FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/97ISR Number: 100000053Report Type:Expedited (15-DaCompany Report #DE97093301A Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa PS 10.00 MG Hospitalization - Circulatory Collapse Health Diazepam C 20.00 MG Initial or Prolonged Professional Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97105236A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS ORAL PO Professional Zolpidem C Lorazepam C Thioridazine C Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97104963A Age:6 WK Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS TRANSPLACENTAL UNK 28 WK Cardiac Murmur Professional Maternal Drugs Affecting Foetus Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97105197A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Fibrosis Health Zyprexa PS 20.00 MG Professional DAILY Haloperidol C Benadryl C Zoloft C Cogentin C Klonopin C Pravachol C Tenormin C Nitroglycerin C Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #GB97103619A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL PO Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #DE97104120A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 10.00 MG; PO Health Professional Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #GB97103925A Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS ORAL 15.00 MG; PO Hospitalization - Phosphokinase Increased Health Levodopa/Benserazide C ORAL 62.50 MG Initial or Prolonged Immobile Professional ;004/DAY; PO Joint Stiffness Other Fluoxetine C ORAL 20.00 MG PO Neuroleptic Malignant Thioridazine C ORAL 30.00 MG PO Syndrome Lisinopril C ORAL 5.00 MG PO Pneumonia Bisacodyl C ORAL 5.00 MG PO Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #IT97103688A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Pneumonia Health DAILY PO Pyrexia Professional Depakine C ORAL 400.00 MG; Stupor 3/DAY; PO Tavor C ORAL 5.00MG; PO Micoren C ORAL 20. MN 1/DAY; ORAL Tavor C INTRAVENOUS 4.00MG; 1/DAY; IV Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #CL97075797A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Dyspnoea Consumer DAILY PO Echolalia Health Prozac C ORAL 80.00 MG Increased Appetite Professional DAILY; ORAL Mania Company Weight Increased Representative Other Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #US97070292A Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Rhabdomyolysis Health DAILY; PO Other Professional Acetaminophen C 24-Jun-2005 12:19 PM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #DE97090310A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Alanine Aminotransferase Health PO Increased Professional Fluanxol C Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hepatocellular Damage Hepatomegaly Hypersensitivity Jaundice Oedema Pyrexia Splenomegaly Date:11/03/97ISR Number: 3005364-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Murmur Olanzapine PS Lilly Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs Sudden Infant Death Syndrome Date:11/03/97ISR Number: 3011590-8Report Type:Periodic Company Report #US97074846A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10 MG DAILY Chest Pain Professional PO Dehydration Calcium Carbonate C Pyrexia Osteoarthritis C Rhabdomyolysis Sedation Date:11/03/97ISR Number: 3011594-5Report Type:Periodic Company Report #US97080142A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Condition Aggravated Health PO Delusion Professional Hydrochlorothiazide C Drug Ineffective Synthroid C K-Dur C Metoprolol C Lorazepam C 24-Jun-2005 12:19 PM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011595-7Report Type:Periodic Company Report #US97080964A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Zyprexa PS ORAL 5.00 MF DAILY Initial or Prolonged Distress Syndrome Professional Provenil C Blood Pressure Increased Atrovent C Coma Convulsion Tachycardia Date:11/03/97ISR Number: 3011598-2Report Type:Periodic Company Report #US97081306A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Irritability Health DAILY PO Mania Professional Date:11/03/97ISR Number: 3011600-8Report Type:Periodic Company Report #US97082461A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Paranoia Health Refusal Of Treatment By Professional Patient Date:11/03/97ISR Number: 3011604-5Report Type:Periodic Company Report #US97082704A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Study Zyprexa PS ORAL 5MG DAILY PO Initial or Prolonged Eye Injury Health Calcium Carbonate C Eye Penetration Professional Colace C Pred-Forte C Timoptic C Ecotrin C Phospholine-Iodide C Dulcolax C Date:11/03/97ISR Number: 3011607-0Report Type:Periodic Company Report #US97084039A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Health Lithium Carbonate C Professional Risperdal C Ativan C Date:11/03/97ISR Number: 3011612-4Report Type:Periodic Company Report #US97084498A Age:87 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cellulitis Initial or Prolonged Delirium Fall 24-Jun-2005 12:19 PM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Pain In Extremity Periorbital Haematoma Report Source Product Role Manufacturer Route Dose Duration Pyrexia Study Zyprexa PS ORAL 10.00 MG Rash Erythematous Health DAILY PO Professional Multivitamins C Nutrition C Peri-Colace C Dulcolax C Lactulose C Date:11/03/97ISR Number: 3011617-3Report Type:Periodic Company Report #US97085023A Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Study Zyprexa PS ORAL 5.00 MG Other Coma Health DAILY PO Hypotension Professional Cipro C Pain Ferrous Sulfate C Prilosec C Peri-Colace C Albuterol C Alprazolam C Date:11/03/97ISR Number: 3011621-5Report Type:Periodic Company Report #US97085167A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Condition Aggravated Health PO Drug Ineffective Professional Vitamin B12 C Oedema Peripheral K-Dur C Artificial Tears C Milk Of Magnesia C Date:11/03/97ISR Number: 3011623-9Report Type:Periodic Company Report #US97090373A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Anger Health PO Hostility Professional Mania Paranoia Psychotic Disorder Date:11/03/97ISR Number: 3011625-2Report Type:Periodic Company Report #US97092296A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Delusion Health PO Drug Withdrawal Syndrome Professional 24-Jun-2005 12:19 PM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011627-6Report Type:Periodic Company Report #US97092452A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Health Valium C Professional Prozac C Salsalate C Benazepril Hydrochloride C Date:11/03/97ISR Number: 3011628-8Report Type:Periodic Company Report #US97092461A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Suicidal Ideation Health Valium C Professional Date:11/03/97ISR Number: 3011630-6Report Type:Periodic Company Report #US97092806A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Suicide Attempt Health Salsalate C Other Professional Ativan C Lithium C Lasix C Coumadin C Date:11/03/97ISR Number: 3011632-XReport Type:Periodic Company Report #US97070766A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa PS ORAL 25 MJG DAILY Abnormal Professional PO Nausea Valproic Acid C Vomiting Date:11/03/97ISR Number: 3011633-1Report Type:Periodic Company Report #US97070775A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa PS ORAL 20.00 MG Initial or Prolonged Drooling Health DAILY PO Ear Infection Professional Trilafon C Eye Movement Disorder Trazodone C Parkinsonism Urinary Retention Date:11/03/97ISR Number: 3011635-5Report Type:Periodic Company Report #US97071180A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Other Neuroleptic Malignant Health Syndrome Professional Company 24-Jun-2005 12:19 PM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Date:11/03/97ISR Number: 3011637-9Report Type:Periodic Company Report #US97072128A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Consumer Zyprexa PS Initial or Prolonged Feeling Cold Health Lithium C Oedema Peripheral Professional Social Avoidant Behaviour Other Stress Date:11/03/97ISR Number: 3011640-9Report Type:Periodic Company Report #US97072134A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO Cognitive Disorder Company Haldol C Depressed Level Of Representative Haldol Decanoate C Consciousness Charcoal, Activated C Dyskinesia Dysphagia Joint Stiffness Muscle Rigidity Neuroleptic Malignant Syndrome Parkinsonian Gait Pyrexia Syncope Tongue Oedema Vomiting Date:11/03/97ISR Number: 3011644-6Report Type:Periodic Company Report #US97072320A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Health Zyprexa PS 15.00MG DAILY Dysphagia Professional PO Respiratory Disorder Depakote C Prozac C Date:11/03/97ISR Number: 3011647-1Report Type:Periodic Company Report #US97072476A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Consumer Zyprexa PS ORAL 20.00 MG Initial or Prolonged Hypertension Health DAILY Other Hypomania Professional Diltiazem C Clonazepam C Lisinopril C Aspirin C Lipitor C Estrogens C 24-Jun-2005 12:19 PM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Valproate Sodium C Date:11/03/97ISR Number: 3011651-3Report Type:Periodic Company Report #US97072785A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Zyprexa PS ORAL 2.50 MG 2/DAY Initial or Prolonged Extrapyramidal Disorder Professional Other Pneumonia Aspiration Other Date:11/03/97ISR Number: 3011654-9Report Type:Periodic Company Report #US97072791A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Other Zyprexa PS ORAL 10.00 MG Initial or Prolonged Lack Of Spontaneous DAILY PO Speech Muscle Rigidity Tremor Date:11/03/97ISR Number: 3011656-2Report Type:Periodic Company Report #US97072797A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Increased Appetite Health Zyprexa PS ORAL 15 MG DAILY 6 MON Initial or Prolonged Oedema Professional Depakote C Polydipsia Other Lasix C Polyuria Amoxicillin C Vomiting Weight Increased Date:11/03/97ISR Number: 3011659-8Report Type:Periodic Company Report #US97072800A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Postural Health Zyprexa PS ORAL 2.5 MG DAILY Initial or Prolonged Myocardial Infarction Professional PO Syncope Other Date:11/03/97ISR Number: 3011662-8Report Type:Periodic Company Report #US97072812A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS 2.50MG DAILY Abnormal Professional PO Tongue Oedema Ativan C Cardizem Cd C Bactrim Ds C Axid C Effexor C 24-Jun-2005 12:19 PM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011665-3Report Type:Periodic Company Report #US97072998A Age:46 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Zyprexa PS Professional Date:11/03/97ISR Number: 3011669-0Report Type:Periodic Company Report #US97073046A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa PS ORAL 50.00 MG UNK Professional PO Zoloft C Date:11/03/97ISR Number: 3011671-9Report Type:Periodic Company Report #US97073247A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO 3 MON Myalgia Myoglobinuria Rhabdomyolysis Date:11/03/97ISR Number: 3011674-4Report Type:Periodic Company Report #US97073268A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Zyprexa PS ORAL 10 MG DAILY Dyspnoea Professional PO Macroglossia Company Cogentin C Representative Ibuprofen C Date:11/03/97ISR Number: 3011677-XReport Type:Periodic Company Report #US97073934A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zyprexa PS ORAL 30.00 MG Inhibition Professional DAILY PO 5 Oedema Peripheral Other WEEKS Ativan C Premarin C Provera C Prazosin C Elavil C K-Dur C Robaxin C Zoloft C Ibuprofen C Lasix C Lotensin C Magnesium Oxide C Norvasc C Risperdal C Albuterol C 24-Jun-2005 12:19 PM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011678-1Report Type:Periodic Company Report #US97073961A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Prozac PS ORAL 10.00 MG Initial or Prolonged Movement Disorder Health DAILY PO Pyrexia Professional Zyprexa SS ORAL 5.00 MG Tremor DAILY PO Tylenol C Lithium C Inderal C Fosamax C Calcium Carbonate C Date:11/03/97ISR Number: 3011682-3Report Type:Periodic Company Report #US97074255A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS ORAL 5.00 MG Initial or Prolonged Fall Professional 2/DAY PO Feeling Hot Other Lethargy Neuroleptic Malignant Syndrome Pyrexia Urine Analysis Abnormal Date:11/03/97ISR Number: 3011683-5Report Type:Periodic Company Report #US97074300A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa PS UNK Professional Date:11/03/97ISR Number: 3011684-7Report Type:Periodic Company Report #US97074306A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 15.00 MG Initial or Prolonged Blood Sodium Decreased Professional DAILY PO 1 WK Hyponatraemia Other Clonazepam C Miosis Albuterol C Sedation Metformin C Vasotec C Lasix C Tegretol C Date:11/03/97ISR Number: 3011687-2Report Type:Periodic Company Report #US97074690A Age:64 YR Gender:Male I/FU:I Outcome PT Other Blood Creatine Phosphokinase Increased Drooling Dyskinesia Dysphagia Hypertension Lethargy 24-Jun-2005 12:19 PM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukocytosis Mental Impairment Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 10.00 MG Syndrome Professional DAILY PO Parkinsonian Gait Other Navane C Pneumonia Pyrexia Salivary Hypersecretion Sedation Tachycardia Upper Respiratory Tract Infection Date:11/03/97ISR Number: 3011691-4Report Type:Periodic Company Report #US97074819A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS ORAL 30.00 MG Initial or Prolonged Blood Creatine Professional DAILY PO Other Phosphokinase Increased Paxil C Delirium Synthroid C Disorientation Drug Level Above Therapeutic Hyperhidrosis Hypertension Restlessness Serotonin Syndrome Tachycardia Urinary Incontinence Date:11/03/97ISR Number: 3011694-XReport Type:Periodic Company Report #US97080403A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Health Zyprexa PS Intervention to Blood Creatine Professional Prevent Permanent Phosphokinase Increased Company Impairment/Damage Dysphagia Representative Hypertonia Hyperventilation Leukocytosis Liver Function Test Abnormal Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tremor Date:11/03/97ISR Number: 3011695-1Report Type:Periodic Company Report #US97081750A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Renal Failure Professional DAILY PO 4 MON Urine Flow Decreased Nafcillin C 24-Jun-2005 12:19 PM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vancomycin C Prozac C Klonopin C Date:11/03/97ISR Number: 3011698-7Report Type:Periodic Company Report #US97082602A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa PS ORAL 5.00 MG Hospitalization - Dyspnoea Professional 2/DAY PO Initial or Prolonged Heart Rate Increased Company Clonazepam C Herpangina Representative Herpes Virus Infection Hypersensitivity Laryngeal Oedema Lung Disorder Pneumonia Aspiration Pyrexia Respiratory Distress Respiratory Failure Respiratory Rate Increased Date:11/03/97ISR Number: 3011701-4Report Type:Periodic Company Report #US97082614A Age:12 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS Agitation Professional Heart Rate Increased Lethargy Sedation Tachypnoea Date:11/03/97ISR Number: 3011704-XReport Type:Periodic Company Report #US97082809A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Zyprexa PS ORAL 10MG DAILY PO 10 DAY Initial or Prolonged Convulsion Professional Cogentin C Synthroid C Date:11/03/97ISR Number: 3011706-3Report Type:Periodic Company Report #US97083556A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 5.00 MG Initial or Prolonged Catatonia Professional DAILY PO Coma Vitamin E C Eye Movement Disorder Benztropine C Face Oedema Haemorrhagic Stroke Hypoaesthesia Oral Tongue Oedema 24-Jun-2005 12:19 PM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011710-5Report Type:Periodic Company Report #US97083568A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Zyprexa PS ORAL 25.00 MG Condition Aggravated Professional DAILY PO Muscle Twitching Benadryl C Date:11/03/97ISR Number: 3011713-0Report Type:Periodic Company Report #US97083577A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Zyprexa PS 30.00 MG UNK Hallucination, Auditory Professional UNK Company Representative Date:11/03/97ISR Number: 3011715-4Report Type:Periodic Company Report #US97083601A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS 15.00 MG Initial or Prolonged Gait Disturbance Professional Paxil C Company Clonapin C Representative Buspar C Date:11/03/97ISR Number: 3011719-1Report Type:Periodic Company Report #US97083793A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Health Zyprexa PS ORAL PO 6 MON Initial or Prolonged Narcolepsy Professional Dilantin C Company Representative Date:11/03/97ISR Number: 3011724-5Report Type:Periodic Company Report #US97084135A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS 25.00MG DAILY Initial or Prolonged Hyperglycaemia Professional PO Other Ketoacidosis Depakote C Polydipsia Polyuria Thirst Date:11/03/97ISR Number: 3011727-0Report Type:Periodic Company Report #US97084261A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS ORAL 140MG PO Coordination Abnormal Professional Lithium C Dysarthria Klonopin C Sedation Synthroid C 24-Jun-2005 12:19 PM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011731-2Report Type:Periodic Company Report #US97084792A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Zyprexa PS Initial or Prolonged Suicidal Ideation Professional Company Representative Date:11/03/97ISR Number: 3011733-6Report Type:Periodic Company Report #US97085020A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa PS ORAL 25.00 MG Aggression Health DAILY PO Anxiety Professional Lorazepam C Hypervigilance Psychotic Disorder Date:11/03/97ISR Number: 3011737-3Report Type:Periodic Company Report #US97085128A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Blood Creatine Professional PO 4 DAY Phosphokinase Increased Depakote C Confusional State Sinemet C Depressed Level Of Consciousness Drug Interaction Dyskinesia Dysphagia Extrapyramidal Disorder Heart Rate Increased Hyperhidrosis Hypotension Muscle Rigidity Neuroleptic Malignant Syndrome Posturing Salivary Hypersecretion Tremor Date:11/03/97ISR Number: 3011740-3Report Type:Periodic Company Report #US97090457A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS 5.00 Initial or Prolonged Parkinsonism Professional Clozaril C Date:11/03/97ISR Number: 3011745-2Report Type:Periodic Company Report #US97090832A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 2.5 MG DAILY Initial or Prolonged Confusional State Professional Paranoia Sedation 24-Jun-2005 12:19 PM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011749-XReport Type:Periodic Company Report #US97091057A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Zyprexa PS 25.00MG UNK Professional UNK Company Representative Date:11/03/97ISR Number: 3011753-1Report Type:Periodic Company Report #US97091084A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS 1 WEEKS Initial or Prolonged Phosphokinase Increased Professional Haldol C Joint Stiffness Company Mental Disorder Representative Pyrexia White Blood Cell Count Increased Date:11/03/97ISR Number: 3011754-3Report Type:Periodic Company Report #US97091330A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Initial or Prolonged Hyperglycaemia Professional Polydipsia Company Representative Date:11/03/97ISR Number: 3011759-2Report Type:Periodic Company Report #US97092005A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Zyprexa PS ORAL 30 MG DAILY Tegretol C Lithium C Date:11/03/97ISR Number: 3011762-2Report Type:Periodic Company Report #US97092314A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zyprexa PS ORAL 2.50 MG DAILY Initial or Prolonged Sedation Professional PO/ 3 WEEKS 3 WK Date:11/03/97ISR Number: 3011768-3Report Type:Periodic Company Report #US97092821A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa PS ORAL 5 MG DAILY Initial or Prolonged Health Lotensin C Professional 24-Jun-2005 12:19 PM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011772-5Report Type:Periodic Company Report #US97093190A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Complications Of Maternal PO/3 MONTH 3 MON Exposure To Therapeutic Klonopin C Drugs Vaginal Haemorrhage Date:11/03/97ISR Number: 3011777-4Report Type:Periodic Company Report #US97093442A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Zyprexa PS ORAL 40MG DAILY PO Health Elavil C Professional Klonopin C Date:11/03/97ISR Number: 3011780-4Report Type:Periodic Company Report #US97093487A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Twitching Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Zoloft C Date:11/03/97ISR Number: 3011784-1Report Type:Periodic Company Report #US97093700A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Hypertension PO Oedema Mouth Clonazepam C Speech Disorder Tongue Oedema Date:11/03/97ISR Number: 3011787-7Report Type:Periodic Company Report #US97074024A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS ORAL 10.00 MG Hyperglycaemia Professional DAILY PO Sertraline C Date:11/03/97ISR Number: 3011790-7Report Type:Periodic Company Report #US97074051A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Discomfort Health Zyprexa PS ORAL 10.00 MG Fatigue Professional DAILY PO Sedation Methocarbamol C 24-Jun-2005 12:19 PM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011794-4Report Type:Periodic Company Report #US97074246A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS 20.00 MG Leukopenia Professional DAILY UNK Neutrophilia Company Representative Date:11/03/97ISR Number: 3011798-1Report Type:Periodic Company Report #US97074288A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgraphia Health Zyprexa PS 5.00 MG 2/DAY Movement Disorder Professional PO Tremor Date:11/03/97ISR Number: 3011802-0Report Type:Periodic Company Report #US97074294A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS ORAL 5.00 MG 2/DAY Movement Disorder Professional PO Date:11/03/97ISR Number: 3011805-6Report Type:Periodic Company Report #US97074303A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 5MG DAILY PO 1 WK Tremor Professional Date:11/03/97ISR Number: 3011807-XReport Type:Periodic Company Report #US97074315A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10MG DAILY PO Weight Increased Date:11/03/97ISR Number: 3011810-XReport Type:Periodic Company Report #US97074321A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa PS ORAL PO 4 MON Health Artane C Professional Prozac C Date:11/03/97ISR Number: 3011813-5Report Type:Periodic Company Report #US97074357A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 5MG DAILY PO 1 MON Professional Lasix C Company Synthroid C Representative Procardia C Coumadin C Potassium C 24-Jun-2005 12:19 PM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Date:11/03/97ISR Number: 3011816-0Report Type:Periodic Company Report #US97074360A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Uric Acid Increased Health Zyprexa PS ORAL 5MG DAILY PO Professional Lithium C Date:11/03/97ISR Number: 3011818-4Report Type:Periodic Company Report #US97074363A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Prozac PS ORAL 20.00MG DAILY Professional PO Zyprexa SS ORAL 20MG DAILY PO Ferrous Sulfate C Folic Acid C Oral Contraceptive Nos C Date:11/03/97ISR Number: 3011822-6Report Type:Periodic Company Report #US97074369A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 10 MG DAILY Professional Company Representative Date:11/03/97ISR Number: 3011824-XReport Type:Periodic Company Report #US97074372A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 5 MG DAILY Professional Depakote C Lopid C Synthroid C Date:11/03/97ISR Number: 3011828-7Report Type:Periodic Company Report #US97074375A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Consumer Zyprexa PS Hallucination, Auditory Date:11/03/97ISR Number: 3011832-9Report Type:Periodic Company Report #US97074378A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 10 MG DAILY Professional Amitriptyline C Trazodone C Loxitane C 24-Jun-2005 12:19 PM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011834-2Report Type:Periodic Company Report #US97074390A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Mania Valproic Acid C Muscle Rigidity Restlessness Tongue Disorder Date:11/03/97ISR Number: 3011837-8Report Type:Periodic Company Report #US97074519A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa PS ORAL PO 9 MON Paranoia Professional Date:11/03/97ISR Number: 3011839-1Report Type:Periodic Company Report #US97074525A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa PS ORAL 10MG DAILY PO Bruxism Professional Lithium C Date:11/03/97ISR Number: 3011840-8Report Type:Periodic Company Report #US97074528A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Consumer Zyprexa PS ORAL 20MG DAILY PO Grunting Prozac C Insomnia Tegretol C Date:11/03/97ISR Number: 3011842-1Report Type:Periodic Company Report #US97074534A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Vesicular Health Zyprexa PS ORAL 5MG DAILY PO 3 WK Professional Trazodone C Zoloft C Ativan C Verapamil C Imitrex C Meclomen C Date:11/03/97ISR Number: 3011845-7Report Type:Periodic Company Report #US97074540A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Health Zyprexa PS ORAL 20MG DAILY PO 3 MON Professional Klonopin C 24-Jun-2005 12:19 PM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011848-2Report Type:Periodic Company Report #US97074555A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Uric Acid Increased Health Zyprexa PS ORAL 20MG DAILY PO Professional Lithobid C Synthroid C Effexor C Diazepam C Date:11/03/97ISR Number: 3011850-0Report Type:Periodic Company Report #US97074558A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 10MG DAILY PO 3 WK Oedema Peripheral Professional Paxil C Date:11/03/97ISR Number: 3011852-4Report Type:Periodic Company Report #US97074588A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS ORAL 15MG DAILY PO Professional Lamictal C Date:11/03/97ISR Number: 3011854-8Report Type:Periodic Company Report #US97074612A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Health Zyprexa PS ORAL 20 MG DAILY Fluctuation Professional Other Date:11/03/97ISR Number: 3011856-1Report Type:Periodic Company Report #US97074615A Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Health Zyprexa PS ORAL 20MG DAILY PO Fluctuation Professional Enalapril C Trifluoperazine C Chlorthalidone C Valproic Acid C Date:11/03/97ISR Number: 3011858-5Report Type:Periodic Company Report #US97074621A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa PS ORAL 5 MG DAILY Syncope Professional Depakote C Tachycardia Other Date:11/03/97ISR Number: 3011860-3Report Type:Periodic Company Report #US97074624A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Coordination Abnormal Health Road Traffic Accident Professional 24-Jun-2005 12:19 PM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Clonazepam C Lithium C Date:11/03/97ISR Number: 3011862-7Report Type:Periodic Company Report #US97074630A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Zyprexa PS ORAL 10 MG DAILY Dermatitis Professional Tylenol C Other Date:11/03/97ISR Number: 3011864-0Report Type:Periodic Company Report #US97074645A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Zyprexa PS ORAL 20 MG DAILY Therapeutic Professional Lithium C Fatigue Other Date:11/03/97ISR Number: 3011867-6Report Type:Periodic Company Report #US97074651A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS ORAL 10MG PO Muscle Twitching Professional Haloperidol C Tremor Other Date:11/03/97ISR Number: 3011871-8Report Type:Periodic Company Report #US97074669A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS 7.50 MG DAILY Professional Lithium C Other Date:11/03/97ISR Number: 3011873-1Report Type:Periodic Company Report #US97074693A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pigmentation Disorder Health Zyprexa PS 10.00 MG Rash Papular Professional 2/DAY Other Date:11/03/97ISR Number: 3011877-9Report Type:Periodic Company Report #US97074978A Age:71 YR Gender:Male I/FU:I Outcome PT Asthenia Dyskinesia Lethargy Therapeutic Agent 24-Jun-2005 12:19 PM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicity Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Lithium C Date:11/03/97ISR Number: 3011879-2Report Type:Periodic Company Report #US97074993A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Health Zyprexa PS ORAL 10MG DAILY PO 1 WK Oedema Peripheral Professional Amoxil C Depakote C Date:11/03/97ISR Number: 3011883-4Report Type:Periodic Company Report #US97074999A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 10MG DAILY PO Dermatitis Professional Zoloft C Pyrexia Risperdal C Klonopin C Date:11/03/97ISR Number: 3011885-8Report Type:Periodic Company Report #US97075005A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS ORAL 5MG DAILY PO Abdominal Pain Professional Benztropine C Constipation Glyburide C Urinary Retention Docusate Sodium C Date:11/03/97ISR Number: 3011887-1Report Type:Periodic Company Report #US97075008A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Health Zyprexa PS ORAL 5MG DAILY PO Professional Date:11/03/97ISR Number: 3011891-3Report Type:Periodic Company Report #US97075011A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Health Zyprexa PS 10.MG DAILY Dysphagia Professional Humabid L.A. C Salivary Hypersecretion Ativan C Date:11/03/97ISR Number: 3011893-7Report Type:Periodic Company Report #US97075014A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 20MG DAILY PO Oedema Peripheral Professional Risperdal C Weight Increased Other Cogentin C 24-Jun-2005 12:19 PM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zestril C Depakote C Theo-Dur C Ventolin C Vistaril C Lasix C Date:11/03/97ISR Number: 3011895-0Report Type:Periodic Company Report #US97075023A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Health Zyprexa PS ORAL 5MG 2/DAY PO Dermatitis Professional Sertraline C Sedation Other Acetaminophen C Date:11/03/97ISR Number: 3011897-4Report Type:Periodic Company Report #US97075026A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10 MG DAILY Dizziness Professional Trazodone C Extrapyramidal Disorder Other Date:11/03/97ISR Number: 3011900-1Report Type:Periodic Company Report #US97075032A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3011903-7Report Type:Periodic Company Report #US97075044A Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15.00 MG Potentiation Professional DAILY PO Drug Level Above Other Clozaril C Therapeutic Procardia Xl C Depakote C Date:11/03/97ISR Number: 3011905-0Report Type:Periodic Company Report #US97075047A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Zyprexa PS ORAL 10 MG DAILY Paraphilia Multivitamins C Psychomotor Hyperactivity Restlessness 24-Jun-2005 12:19 PM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011908-6Report Type:Periodic Company Report #US97075050A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20 MG DAILY 2 MON Professional Date:11/03/97ISR Number: 3011910-4Report Type:Periodic Company Report #US97075056A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Fibrosis Health Zyprexa PS ORAL PO Professional Date:11/03/97ISR Number: 3011912-8Report Type:Periodic Company Report #US97075071A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Health Zyprexa PS ORAL 10MG DAILY PO Tardive Dyskinesia Professional Other Date:11/03/97ISR Number: 3011916-5Report Type:Periodic Company Report #US97075074A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS 10.00 MG Oedema Peripheral Professional DAILY Weight Increased Other Prozac C Diazepam C Depakote C Pepcid C Hydrocortisone C Date:11/03/97ISR Number: 3011919-0Report Type:Periodic Company Report #US97075077A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS ORAL 5.00 MG Injury Professional 3/DAY PO Oedema Peripheral Other Lovothyroxine C Ibuprofen C Plaquenil C Date:11/03/97ISR Number: 3011921-9Report Type:Periodic Company Report #US97075083A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011923-2Report Type:Periodic Company Report #US97075089A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Zyprexa PS ORAL 5 MG DAILY PO Loss Of Control Of Legs Professional Maxzide C Carbidopa C Levodopa C Date:11/03/97ISR Number: 3011925-6Report Type:Periodic Company Report #US97075092A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Delusion Professional Schizophrenia Company Representative Date:11/03/97ISR Number: 3011929-3Report Type:Periodic Company Report #US97075098A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS ORAL 10MG DAILY PO Weight Decreased Professional Vitamin E C Depakote C Buspar C Date:11/03/97ISR Number: 3011932-3Report Type:Periodic Company Report #US97075104A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Health Zyprexa PS ORAL 10 MG DAILY Drug Interaction Professional PO Inhibition Other Depakote C Date:11/03/97ISR Number: 3011934-7Report Type:Periodic Company Report #US97075107A Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS ORAL 5MG DAILY PO Dizziness Professional Valproate Sodium C Hypotension Other Pallor Sedation Date:11/03/97ISR Number: 3011938-4Report Type:Periodic Company Report #US97075125A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Consumer Zyprexa PS ORAL 15 MG DAILY 2 MON Seborrhoea Prolixin C 24-Jun-2005 12:19 PM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011941-4Report Type:Periodic Company Report #US97075134A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Serzone C Date:11/03/97ISR Number: 3011942-6Report Type:Periodic Company Report #US97075158A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20.00 MG Hallucination, Auditory Professional DAILY PO Intentional Self-Injury Vitamin E C Paxil C Haldol C Xanax C Dalmane C Date:11/03/97ISR Number: 3011945-1Report Type:Periodic Company Report #US97075164A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20 MG DAILY Hallucination, Auditory Professional PO Klonopin C Date:11/03/97ISR Number: 3011948-7Report Type:Periodic Company Report #US97075173A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Company Representative Date:11/03/97ISR Number: 3011950-5Report Type:Periodic Company Report #US97075188A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Consumer Zyprexa PS ORAL 10 MG DAILY Face Oedema PO Date:11/03/97ISR Number: 3011954-2Report Type:Periodic Company Report #US97075197A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS ORAL 10.00 MG Dehydration Health 2/DAY PO Depression Professional Desipramine C Dizziness Ativan C Polydipsia Artane C Restlessness Serzone C Temperature Intolerance 24-Jun-2005 12:19 PM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011958-XReport Type:Periodic Company Report #US97075284A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Health Zyprexa PS ORAL 15MG DAILY PO Professional Tegretol C Klonopin C Cogentin C Prozac C Date:11/03/97ISR Number: 3011960-8Report Type:Periodic Company Report #US97075335A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS ORAL 10 MG DAILY Joint Stiffness PO Pain Carbamazepine C Fluoxetine C Clonazepam C Benztropine C Date:11/03/97ISR Number: 3011963-3Report Type:Periodic Company Report #US97075389A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 10 MD DAILY Professional PO 5 MON Zithromax C Date:11/03/97ISR Number: 3011965-7Report Type:Periodic Company Report #US97075416A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 7.5 MG DAILY Sedation PO Serzone C Klonopin C Date:11/03/97ISR Number: 3011967-0Report Type:Periodic Company Report #US97075425A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 MON Sedation Date:11/03/97ISR Number: 3011968-2Report Type:Periodic Company Report #US97075473A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa PS ORAL 5 MG 2/DAY Professional PO 8 MON Artane C Vitamin E C 24-Jun-2005 12:19 PM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011982-7Report Type:Periodic Company Report #US97075437A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Other Zyprexa PS ORAL 17.5 MG DAILY Fatigue PO Illusion Nefazodone C Date:11/03/97ISR Number: 3011983-9Report Type:Periodic Company Report #US97075479A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10 MG DAILY Professional PO 2 MON Date:11/03/97ISR Number: 3011986-4Report Type:Periodic Company Report #US97075485A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faecal Incontinence Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 WK Weight Increased Date:11/03/97ISR Number: 3011988-8Report Type:Periodic Company Report #US97075494A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10 MG DAILY Professional PO 1 MON Paxil C Date:11/03/97ISR Number: 3011989-XReport Type:Periodic Company Report #US97075506A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 20MG DAILY PO 6 WK Health Anafranil C Professional Date:11/03/97ISR Number: 3011991-8Report Type:Periodic Company Report #US97075509A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15MG DAILY PO Potentiation Professional Vistaril C Hallucination Date:11/03/97ISR Number: 3012015-9Report Type:Periodic Company Report #US97092953A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNKNOWN Professional Company Representative 24-Jun-2005 12:19 PM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012016-0Report Type:Periodic Company Report #US97092959A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Prozac C Date:11/03/97ISR Number: 3012017-2Report Type:Periodic Company Report #US97092962A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Company Representative Date:11/03/97ISR Number: 3012018-4Report Type:Periodic Company Report #US97092965A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL UNK;DAILY; PO 1 MON Abnormal Professional Tegretol C Ativan C Date:11/03/97ISR Number: 3012021-4Report Type:Periodic Company Report #US97093184A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Health Zyprexa PS 20.00MG DAILY Exposure To Therapeutic Professional PO Drugs Folic Acid C Nutritional Supplements C Date:11/03/97ISR Number: 3012023-8Report Type:Periodic Company Report #US97093196A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS UNK Professional Luvox C Date:11/03/97ISR Number: 3012025-1Report Type:Periodic Company Report #US97093199A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Distractibility Health Zyprexa PS ORAL 10.00 MG Flight Of Ideas Professional DAILY PO 1 WK Sedation Valproic Acid C Suspiciousness Weight Increased 24-Jun-2005 12:19 PM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012028-7Report Type:Periodic Company Report #US97093244A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS UNK Professional Luvox C Date:11/03/97ISR Number: 3012030-5Report Type:Periodic Company Report #US97093274A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Health Zyprexa PS ORAL 2.5MG DAILY Professional PO Date:11/03/97ISR Number: 3012032-9Report Type:Periodic Company Report #US97093388A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Zyprexa PS ORAL 15.00 MG Aggression Professional DAILY PO Irritability Clonazepam C Obsessive Thoughts Lamotrigine C Nefazodone C Cytomel C Date:11/03/97ISR Number: 3012035-4Report Type:Periodic Company Report #US97093400A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS ORAL 10.00 MG Irritability Professional DAILY PO/ 1 Logorrhoea WEEKS 1 WK Mania Lorazepam C Paranoia Valproic C Sedation Suspiciousness Date:11/03/97ISR Number: 3012037-8Report Type:Periodic Company Report #US97093481A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 40MG PO Professional Navane C Doxepin C Depakote C Date:11/03/97ISR Number: 3012039-1Report Type:Periodic Company Report #US97093496A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Health Zyprexa PS ORAL 7.50 MG DAILY Delusion Professional PO 24-Jun-2005 12:19 PM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012041-XReport Type:Periodic Company Report #US97093529A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Consumer Zyprexa PS Date:11/03/97ISR Number: 3012044-5Report Type:Periodic Company Report #US97093532A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO Date:11/03/97ISR Number: 3012047-0Report Type:Periodic Company Report #US97092926A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Health Zyprexa PS ORAL 5.00 MG DAILY Urinary Incontinence Professional PO Prozac SS UNK Date:11/03/97ISR Number: 3012049-4Report Type:Periodic Company Report #US97092929A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa PS ORAL 20.00 MG 2/DAY PO Zoloft C Zestril C Date:11/03/97ISR Number: 3012052-4Report Type:Periodic Company Report #US97092932A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20MG DAILY PO Professional Clozaril C Company Depakote C Representative Date:11/03/97ISR Number: 3012054-8Report Type:Periodic Company Report #US97092935A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Prozac C Date:11/03/97ISR Number: 3012058-5Report Type:Periodic Company Report #US97092938A Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Prozac SS ORAL 20.00 MG DAILY PO Valium C 24-Jun-2005 12:19 PM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012062-7Report Type:Periodic Company Report #US97092944A Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Health Zyprexa PS ORAL 20.00 MG Faecal Incontinence Professional DAILY PO Urinary Incontinence Prozac SS ORAL 10.00 MG DAILY PO Lithium C Levothyroxine C Date:11/03/97ISR Number: 3012067-6Report Type:Periodic Company Report #US97092947A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Retroperitoneal Oedema Professional Company Representative Date:11/03/97ISR Number: 3012076-7Report Type:Periodic Company Report #US97092869A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Consumer Zyprexa PS ORAL 30.00 MG Drug Ineffective DAILY PO 3 MON Medication Error Paxil C Date:11/03/97ISR Number: 3012079-2Report Type:Periodic Company Report #US97092872A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Health Zyprexa PS ORAL 10.00 MG Increased Professional DAILY PO Liver Function Test Clonidine C Abnormal Claritin C Thorazine C Date:11/03/97ISR Number: 3012084-6Report Type:Periodic Company Report #US97092875A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS SUBCUTANEOUS 7.50MG DAILY Paranoia Health SC 3 MON Sedation Professional Date:11/03/97ISR Number: 3012087-1Report Type:Periodic Company Report #US97092893A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa PS 20.00 MG Professional Company Representative 24-Jun-2005 12:19 PM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012089-5Report Type:Periodic Company Report #US97092896A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS 25.00MG DAILY Hallucination Professional Serzone C Ativan C Date:11/03/97ISR Number: 3012093-7Report Type:Periodic Company Report #US97092899A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10 MG DAILY Professional PO Vitamin E C Lorazepam C Date:11/03/97ISR Number: 3012113-XReport Type:Periodic Company Report #US97092917A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperbilirubinaemia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Cogentin C Klonopin C Amantadine C Date:11/03/97ISR Number: 3012117-7Report Type:Periodic Company Report #US97092923A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3012121-9Report Type:Periodic Company Report #US97092455A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS ORAL 15 MG DAILY Phosphokinase Increased Professional PO Sertraline C Lasix C Librium C Insulin C Prevacid C Imdur C Synthroid C Date:11/03/97ISR Number: 3012124-4Report Type:Periodic Company Report #US97092491A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Other Zyprexa PS UNK 24-Jun-2005 12:19 PM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012141-4Report Type:Periodic Company Report #US97092506A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 15.00 MG Weight Increased DAILY PO 3 MON Prozac C Date:11/03/97ISR Number: 3012142-6Report Type:Periodic Company Report #US97092851A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15..00 MG Professional DAILY PO Cogentin C Depakote C Ativan C Ativan C Date:11/03/97ISR Number: 3012146-3Report Type:Periodic Company Report #US97092854A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 20.00 MG Abnormal Professional DAILY PO Risperdal C Date:11/03/97ISR Number: 3012149-9Report Type:Periodic Company Report #US97092863A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antepartum Haemorrhage Consumer Zyprexa PS ORAL 10MG DAILY PO Date:11/03/97ISR Number: 3012153-0Report Type:Periodic Company Report #US97092866A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS 5.00MG/DAILY/ PO Klonopin C Trazodone C Depakote C Date:11/03/97ISR Number: 3012155-4Report Type:Periodic Company Report #US97092080A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00MG/DAILY/ Sleep Disorder PO Weight Increased 24-Jun-2005 12:19 PM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012159-1Report Type:Periodic Company Report #US97092083A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20.00MG/DAILY Professional /PO 6 MON Prozac C Date:11/03/97ISR Number: 3012161-XReport Type:Periodic Company Report #US97092086A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Zyprexa PS Prolonged Professional Oedema Company Representative Date:11/03/97ISR Number: 3012162-1Report Type:Periodic Company Report #US97092089A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akinesia Health Zyprexa PS ORAL 10.00MG/DAILY Hypoaesthesia Oral Professional /PO Weight Increased Paxil C Date:11/03/97ISR Number: 3012165-7Report Type:Periodic Company Report #US97092098A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS ORAL 10.00MG Chest Discomfort 3/WEEK PO Lithium C Date:11/03/97ISR Number: 3012168-2Report Type:Periodic Company Report #US97092104A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS 15 MG Professional Company Representative Date:11/03/97ISR Number: 3012171-2Report Type:Periodic Company Report #US97092107A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Health Zyprexa PS ORAL 15 MG DAILY Delusion Professional PO Hallucination, Auditory Date:11/03/97ISR Number: 3012173-6Report Type:Periodic Company Report #US97092110A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 7.5 DAILY PO Professional Depakote C 24-Jun-2005 12:19 PM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012176-1Report Type:Periodic Company Report #US97092122A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Consumer Zyprexa PS ORAL 10 MG DAILY Hyperhidrosis Health PO 2 MON Weight Increased Professional Risperdal C Date:11/03/97ISR Number: 3012178-5Report Type:Periodic Company Report #US97092332A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3012211-0Report Type:Periodic Company Report #US97092446A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Weight Increased Professional Date:11/03/97ISR Number: 3025923-XReport Type:Periodic Company Report #US97092008A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 2 MON Date:11/03/97ISR Number: 3025926-5Report Type:Periodic Company Report #US97092017A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cytomegalovirus Infection Other Zyprexa PS ORAL 15.00 MG Hepatic Function Abnormal DAILY PO 3 DAY Lithium C Lorazepam C Date:11/03/97ISR Number: 3025930-7Report Type:Periodic Company Report #US97092023A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Oedema Health Zyprexa PS ORAL 15.00 MG Face Oedema Professional DAILY PO 1 MON Oedema Peripheral Lorazepam C Prozac C Date:11/03/97ISR Number: 3025933-2Report Type:Periodic Company Report #US97092029A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 9 MON Klonopin C 24-Jun-2005 12:19 PM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025937-XReport Type:Periodic Company Report #US97092041A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa PS ORAL 20.00 MG Restlessness Professional DAILY PO 2 MON Company Representative Date:11/03/97ISR Number: 3025940-XReport Type:Periodic Company Report #US97092074A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS 10.00 MG Professional Depakote C Company Representative Date:11/03/97ISR Number: 3025942-3Report Type:Periodic Company Report #US97091435A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 20.00 MG DAILY PO 8 WK Ativan C Zoloft C Date:11/03/97ISR Number: 3025945-9Report Type:Periodic Company Report #US97091438A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Serzone C Klonopin C Wellbutrin C Neurontin C Date:11/03/97ISR Number: 3025948-4Report Type:Periodic Company Report #US97091444A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 3 MON Tegretal C Date:11/03/97ISR Number: 3025949-6Report Type:Periodic Company Report #US97091450A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Formication Consumer Zyprexa PS ORAL 15.00 MG Nausea DAILY PO 2 MON Pruritus Cogentin C Vomiting Navane C 24-Jun-2005 12:19 PM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025954-XReport Type:Periodic Company Report #US97091486A Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Tremor Company Clozaril C Representative Date:11/03/97ISR Number: 3025957-5Report Type:Periodic Company Report #US97091954A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 MON Company Representative Date:11/03/97ISR Number: 3025960-5Report Type:Periodic Company Report #US97091417A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS ORAL 15.00 MG Throat Tightness Professional DAILY PO Effexor C Buspar C Date:11/03/97ISR Number: 3025965-4Report Type:Periodic Company Report #US97091411A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Health Zyrexa PS ORAL 10.00 MG Professional DAILY PO Lithium C Depakote C Date:11/03/97ISR Number: 3025966-6Report Type:Periodic Company Report #US97091402A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Effexor C Cogentin C Date:11/03/97ISR Number: 3025967-8Report Type:Periodic Company Report #US970191405A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polydipsia Health Zyprexa PS ORAL 20.00 MG Thirst Professional DAILY PO 2 MON Glucotrol C Prinivil C Nortriptyline C 24-Jun-2005 12:19 PM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025970-8Report Type:Periodic Company Report #US97090868A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 2.50 MG PO Parkinson'S Disease Professional Date:11/03/97ISR Number: 3025973-3Report Type:Periodic Company Report #US97090871A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.50 35 DAY Professional L-Dopa C Pergolide C Clozaril C Date:11/03/97ISR Number: 3025975-7Report Type:Periodic Company Report #US97090874A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 5.00 22 DAY Professional L-Dopa C Clozaril C Date:11/03/97ISR Number: 3025979-4Report Type:Periodic Company Report #US97091069A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Zyprexa PS ORAL 10.00 MG Dyskinesia Professional DAILY PO Other Dexedrine C Date:11/03/97ISR Number: 3025982-4Report Type:Periodic Company Report #US97091072A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Date:11/03/97ISR Number: 3025984-8Report Type:Periodic Company Report #US97091075A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Professional Desipramine C Company Representative Date:11/03/97ISR Number: 3025986-1Report Type:Periodic Company Report #US97091078A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Health Prozac PS Professional Zyprexa SS 24-Jun-2005 12:19 PM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025989-7Report Type:Periodic Company Report #US97091111A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3025990-3Report Type:Periodic Company Report #US97091204A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 5.00 MG DAILY Dysphonia Health PO Throat Irritation Professional Lithium C Ativan C Date:11/03/97ISR Number: 3025994-0Report Type:Periodic Company Report #US97090859A Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.50 MG PO 36 DAY Professional L-Dopa C Clozaril C Date:11/03/97ISR Number: 3025996-4Report Type:Periodic Company Report #US97090862A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.50 MG PO 14 DAY Professional L-Dopa C Pergolide C Clozaril C Date:11/03/97ISR Number: 3025998-8Report Type:Periodic Company Report #US97090865A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.50 24 DAY Professional L-Dopa C Amantadine C Clozaril C Date:11/03/97ISR Number: 3026002-8Report Type:Periodic Company Report #US97090847A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 2.50 PO Insomnia Professional Date:11/03/97ISR Number: 3026003-XReport Type:Periodic Company Report #US97090850A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026004-1Report Type:Periodic Company Report #US97090853A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.5 MG PO Professional Date:11/03/97ISR Number: 3026006-5Report Type:Periodic Company Report #US97090856A Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.5 MG 6 DAY Professional L-Dopa C Amantadine C Clozaril C Date:11/03/97ISR Number: 3026007-7Report Type:Periodic Company Report #US97084879A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 2.5 MG DAILY Panic Attack Health PO 6 WK Professional Xanax C Date:11/03/97ISR Number: 3026008-9Report Type:Periodic Company Report #US97084888A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photopsia Health Zyprexa PS ORAL PO Professional Other Date:11/03/97ISR Number: 3026011-9Report Type:Periodic Company Report #US97084858A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Other Date:11/03/97ISR Number: 3026013-2Report Type:Periodic Company Report #US97084801A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 1 MON Haldol C N/A C Date:11/03/97ISR Number: 3026014-4Report Type:Periodic Company Report #US97084816A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Fluid Retention Health Influenza Like Illness Professional Company 24-Jun-2005 12:19 PM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS 10 MG Lithium C Date:11/03/97ISR Number: 3026017-XReport Type:Periodic Company Report #US97084855A Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Health Zyprexa PS Tic Professional Clonidine C Tourette'S Disorder Date:11/03/97ISR Number: 3026019-3Report Type:Periodic Company Report #US97084783A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 10 MG DAILY Drug Level Above Health PO 5 MON Therapeutic Professional Zocor C Zoloft C Synthroid C Prilosec C Premarin C Naproxen C Date:11/03/97ISR Number: 3026021-1Report Type:Periodic Company Report #US97084753A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS UNK 2 WK Back Pain Risperdal C Date:11/03/97ISR Number: 3026022-3Report Type:Periodic Company Report #US97084780A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3026024-7Report Type:Periodic Company Report #US97084579A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Depakote C Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026025-9Report Type:Periodic Company Report #US97084570A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Depakote C Company Paxil C Representative Date:11/03/97ISR Number: 3026027-2Report Type:Periodic Company Report #US97084564A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Lithium C Company Serzone C Representative Date:11/03/97ISR Number: 3026028-4Report Type:Periodic Company Report #US97084339A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3026029-6Report Type:Periodic Company Report #US97084534A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Consumer Zyprexa PS ORAL PO Flushing Oedema Peripheral Date:11/03/97ISR Number: 3026031-4Report Type:Periodic Company Report #US97084231A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Health Zyprexa PS ORAL 10 MG DAILY Professional PO Lithium C Date:11/03/97ISR Number: 3026033-8Report Type:Periodic Company Report #US97084267A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 WK Fatigue Health Clonazepam C Professional Neurontin C Hydrochlorothiazide C Potassium C 24-Jun-2005 12:19 PM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026036-3Report Type:Periodic Company Report #US97084309A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Consumer Zyprexa PS ORAL 2.5 MG DAILY Restlessness Health PO 2 WK Sedation Professional Ativan C Premarin C Progesterone C Ginkobiloba C Date:11/03/97ISR Number: 3026039-9Report Type:Periodic Company Report #US97084108A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Hypersensitivity Health Zyprexa PS Pruritus Professional Company Representative Date:11/03/97ISR Number: 3026041-7Report Type:Periodic Company Report #US97084117A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Lithium C Lorazepam C Date:11/03/97ISR Number: 3026043-0Report Type:Periodic Company Report #US97084123A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 5 MG DAILY PO 2 MON Professional Lithium C Date:11/03/97ISR Number: 3026047-8Report Type:Periodic Company Report #US97084138A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 5 MG DAILY PO 2 WK Professional Company Representative Date:11/03/97ISR Number: 3026048-XReport Type:Periodic Company Report #US97084228A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Health Zyprexa PS ORAL 10 MG DAILY Oedema Professional PO Weight Increased 24-Jun-2005 12:19 PM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026051-XReport Type:Periodic Company Report #US97083883A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS 20 MG UNK Professional Company Representative Date:11/03/97ISR Number: 3026053-3Report Type:Periodic Company Report #US97083886A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deafness Health Zyprexa PS Professional Risperdal C Company Representative Date:11/03/97ISR Number: 3026056-9Report Type:Periodic Company Report #US97083892A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Zyprexa PS ORAL 10 MG DAILY Tremor Health PO Professional Date:11/03/97ISR Number: 3026057-0Report Type:Periodic Company Report #US97084057A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 5 MG DAILY PO Drug Level Above Professional Depakote C Therapeutic Ativan C Date:11/03/97ISR Number: 3026059-4Report Type:Periodic Company Report #US97083877A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Pain Health Zyprexa PS 5 MG UNK 2 MON Pyrexia Professional Company Representative Date:11/03/97ISR Number: 3026060-0Report Type:Periodic Company Report #US97083880A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS ORAL 10 MG PO 1 MON Weight Increased Professional Company Representative 24-Jun-2005 12:19 PM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027333-8Report Type:Periodic Company Report #US97081042A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG DAILY Health PO Professional Date:11/03/97ISR Number: 3027335-1Report Type:Periodic Company Report #US97081045A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Prozac PS 3 MON Professional Zyprexa SS 3 MON Date:11/03/97ISR Number: 3027336-3Report Type:Periodic Company Report #US97081156A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS 1 YR Professional Paxil C Cogentin C Haldol C Benadryl C Zantac C Depo-Provera C Date:11/03/97ISR Number: 3027338-7Report Type:Periodic Company Report #US97081180A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS ORAL 2.5 MG DAILY Professional PO 1 WK Lithium C Date:11/03/97ISR Number: 3027339-9Report Type:Periodic Company Report #US97081186A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Sedation Professional DAILY PO 1 MON Weight Increased Lasix C Effexor C Date:11/03/97ISR Number: 3027340-5Report Type:Periodic Company Report #US97081318A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 15.00 MG Hostility Professional DAILY PO Sedation 24-Jun-2005 12:19 PM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027341-7Report Type:Periodic Company Report #US97081510A Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 WK Company Maxzide C Representative Date:11/03/97ISR Number: 3027342-9Report Type:Periodic Company Report #US97080988A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Lithium C Tegretol C Date:11/03/97ISR Number: 3027343-0Report Type:Periodic Company Report #US97081012A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Emotional Disorder Consumer Zyprexa PS ORAL 10.00 MG Feeling Abnormal DAILY PO 1 WK Loxapine C Date:11/03/97ISR Number: 3027344-2Report Type:Periodic Company Report #US97081015A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Serzone C Representative Zoloft C Date:11/03/97ISR Number: 3027345-4Report Type:Periodic Company Report #US97081018A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 1 MON Benztropine C Date:11/03/97ISR Number: 3027346-6Report Type:Periodic Company Report #US97081024A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027347-8Report Type:Periodic Company Report #US97081030A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Desyrl C Representative Date:11/03/97ISR Number: 3027348-XReport Type:Periodic Company Report #US97081033A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Professional Depakote C Company Representative Date:11/03/97ISR Number: 3027349-1Report Type:Periodic Company Report #US97081036A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 WK Company Depakote C Representative Navane C Date:11/03/97ISR Number: 3027350-8Report Type:Periodic Company Report #US97080229A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agoraphobia Consumer Zyprexa PS ORAL 12.5 MG DAILY PO 7 WK Inderal C Date:11/03/97ISR Number: 3027351-XReport Type:Periodic Company Report #US97080238A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 3 WK Pamelor C Tranxene C Date:11/03/97ISR Number: 3027352-1Report Type:Periodic Company Report #US97080295A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharitis Health Zyprexa PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027353-3Report Type:Periodic Company Report #US97080301A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Health Zyprexa PS ORAL 1.25 MG DAILY Professional PO 1 WK Valproic C Date:11/03/97ISR Number: 3027354-5Report Type:Periodic Company Report #US97080517A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Risperdal C Date:11/03/97ISR Number: 3027355-7Report Type:Periodic Company Report #US97080526A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Haldol C Klonopin C Date:11/03/97ISR Number: 3027356-9Report Type:Periodic Company Report #US97080856A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Disorder Health Zyprexa PS Professional Zyprexa C Company A C Representative Zyprexa I Date:11/03/97ISR Number: 3027357-0Report Type:Periodic Company Report #US97080985A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL Other Depakote C Artane C Date:11/03/97ISR Number: 3027359-4Report Type:Periodic Company Report #US97075668A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 15.00 MG Decreased Professional DAILY PO Company Risperdal C Representative 24-Jun-2005 12:19 PM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027360-0Report Type:Periodic Company Report #US97075728A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Consumer Prozac PS 2 YR Sedation Zyprexa SS ORAL 10.00 MG Vision Blurred DAILY PO Weight Increased Haldol C Benadryl C Date:11/03/97ISR Number: 3027361-2Report Type:Periodic Company Report #US97075887A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027362-4Report Type:Periodic Company Report #US97075908A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 DAY Risperdal C Prozac C Wellbutrin C Ativan C Buspar C Date:11/03/97ISR Number: 3027363-6Report Type:Periodic Company Report #US97075917A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa PS ORAL 30.00 MG Constipation Professional DAILY PO 3 MON Faecaloma Date:11/03/97ISR Number: 3027364-8Report Type:Periodic Company Report #US97075923A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 15.00 MG DAILY PO Depakote C Serenil C Date:11/03/97ISR Number: 3027365-XReport Type:Periodic Company Report #US97075926A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Lasix C Representative 24-Jun-2005 12:19 PM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027366-1Report Type:Periodic Company Report #US97075932A Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Consumer Zyprexa PS ORAL 5.00 MG DAILY Weight Increased PO Ritalin C Date:11/03/97ISR Number: 3027367-3Report Type:Periodic Company Report #US97076055A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Consumer Zyprexa PS Date:11/03/97ISR Number: 3027368-5Report Type:Periodic Company Report #US97076103A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 5.00 MG PO Hallucination Professional Vasotec C Muscle Rigidity Other Paxil C Tremor Asa C Date:11/03/97ISR Number: 3027369-7Report Type:Periodic Company Report #US97076154A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO 2 MON Depakote C Benztropine C Date:11/03/97ISR Number: 3027370-3Report Type:Periodic Company Report #US97076157A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred PO 6 DAY Effexor C Ery-Tab C Dihistine C Date:11/03/97ISR Number: 3027371-5Report Type:Periodic Company Report #US97076199A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Health Zyprexa PS 5.00 MG Photophobia Professional Company Representative 24-Jun-2005 12:19 PM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027372-7Report Type:Periodic Company Report #US97076202A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 10.00 MG Paranoid Personality DAILY PO Disorder Date:11/03/97ISR Number: 3027373-9Report Type:Periodic Company Report #US97076208A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 20.00 MG Livedo Reticularis Professional DAILY PO Purpura Haldol C Prozac C Lorazepam C Artane C Date:11/03/97ISR Number: 3027374-0Report Type:Periodic Company Report #US97076211A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Facial Palsy Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027375-2Report Type:Periodic Company Report #US97076217A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3027376-4Report Type:Periodic Company Report #US97076226A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Consumer Zyprexa PS ORAL 20.00 MG DAILY PO 4 WK Date:11/03/97ISR Number: 3027377-6Report Type:Periodic Company Report #US97076238A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Health Zyprexa PS ORAL 1 MON Professional Prolixin C Naprosyn C Cogentin C Prozac C 24-Jun-2005 12:19 PM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027378-8Report Type:Periodic Company Report #US97076250A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Date:11/03/97ISR Number: 3027379-XReport Type:Periodic Company Report #US97076253A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS ORAL 10.00 MG Dyspnoea Professional DAILY PO Heart Rate Increased Date:11/03/97ISR Number: 3027442-3Report Type:Periodic Company Report #US97076259A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Paxil C Loxitane C Dilantin C Remeron C Tegretol C Date:11/03/97ISR Number: 3027445-9Report Type:Periodic Company Report #US97076262A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiv Test Positive Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO 3 WK Decreased Haldol C Date:11/03/97ISR Number: 3027450-2Report Type:Periodic Company Report #US97080145A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Zoloft C Reglan C Date:11/03/97ISR Number: 3027453-8Report Type:Periodic Company Report #US97080148A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Bilirubin Increased Consumer Zyprexa PS ORAL 10.00 MGDAILY Cholelithiasis Health PO Liver Function Test Professional Depakote C Abnormal Tylenol C 24-Jun-2005 12:19 PM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027924-4Report Type:Periodic Company Report #US97093754A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Glucose Tolerance Professional DAILY PO Decreased Company Haldol C Hyperlipidaemia Representative Paxil C Oesophagitis Weight Increased Date:11/03/97ISR Number: 3027927-XReport Type:Periodic Company Report #US97093775A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Zyprexa PS ORAL 40.00 MG Increased Professional DAILY PO Date:11/03/97ISR Number: 3027929-3Report Type:Periodic Company Report #US97094222A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Mental Impairment Professional DAILY PO Synthroid C Haloperidol C Date:11/03/97ISR Number: 3027932-3Report Type:Periodic Company Report #US97094585A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO 4 MON Coma Company Delirium Representative Hyponatraemia Neuroleptic Malignant Syndrome Polydipsia Psychogenic Pyrexia Date:11/03/97ISR Number: 3027935-9Report Type:Periodic Company Report #US97094795A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 600.00 MG PO Initial or Prolonged Hypotension Professional Zoloft C Other Overdose Depakote C Coumadin C Date:11/03/97ISR Number: 3027938-4Report Type:Periodic Company Report #US97095449A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS 150.00 MG Sedation Professional Venlafaxine C Tachycardia 24-Jun-2005 12:19 PM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027940-2Report Type:Periodic Company Report #US97095674A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Zyprexa PS ORAL 40.00 MG Initial or Prolonged Loss Of Control Of Legs Professional DAILY PO Other Company Trazodone C Representative Glipizide C Date:11/03/97ISR Number: 3027943-8Report Type:Periodic Company Report #US97100151A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pyrexia Professional PO 2 DAY Sleep Talking Company Trazodone C Tremor Representative Tegretol C Xanax C Date:11/03/97ISR Number: 3027946-3Report Type:Periodic Company Report #US97072011A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Study Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Date:11/03/97ISR Number: 3027949-9Report Type:Periodic Company Report #US97071243A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS ORAL 10.00 MG Akathisia Health DAILY PO Nervousness Professional Risperdal C Sedation Date:11/03/97ISR Number: 3027951-7Report Type:Periodic Company Report #US97071261A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 5.00 MG DAILY Hypersomnia PO Urinary Incontinence Synthroid C Date:11/03/97ISR Number: 3027954-2Report Type:Periodic Company Report #US97071264A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa PS ORAL 5.00 MG DAILY Feeling Abnormal Professional PO Increased Appetite Depakote C Sedation Tegretol C Paxil C 24-Jun-2005 12:19 PM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027955-4Report Type:Periodic Company Report #US97071285A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 5.00 MG DAILY Abnormal Professional PO 3 MON Pyrexia Company Representative Date:11/03/97ISR Number: 3027958-XReport Type:Periodic Company Report #US97071291A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 7.5 MG DAILY Health PO Professional Prozac C Date:11/03/97ISR Number: 3027960-8Report Type:Periodic Company Report #US97071312A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Consumer Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred PO 1 MON Claritin-D C Date:11/03/97ISR Number: 3027963-3Report Type:Periodic Company Report #US97071315A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Valium C Restoril C Date:11/03/97ISR Number: 3027967-0Report Type:Periodic Company Report #US97071318A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 3 MON Clozaril C Cogentin C Depakote C Ativan C Date:11/03/97ISR Number: 3027970-0Report Type:Periodic Company Report #US97071321A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Consumer Zyprexa PS ORAL 2.5 MG DAILY Epistaxis PO 3 WK Hyperhidrosis Effexor C Klonopin C .25 MG 1/D Klonopin C 1.00 MG 1/D 24-Jun-2005 12:19 PM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027973-6Report Type:Periodic Company Report #US97071324A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS 5.00 MG DAILY Professional Date:11/03/97ISR Number: 3027976-1Report Type:Periodic Company Report #US97071339A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Health Zyprexa PS ORAL 20.00 MG Pyrexia Professional DAILY PO Prozac SS 40.00 MG Trazodone C Demadex C Centrum C Relafen C Date:11/03/97ISR Number: 3027978-5Report Type:Periodic Company Report #US97071483A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027982-7Report Type:Periodic Company Report #US97071498A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Other Date:11/03/97ISR Number: 3027984-0Report Type:Periodic Company Report #US97071531A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027987-6Report Type:Periodic Company Report #US97071534A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027991-8Report Type:Periodic Company Report #US97071543A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Other 24-Jun-2005 12:19 PM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027994-3Report Type:Periodic Company Report #US97071564A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 25.00 MG Professional DAILY PO Other Haldol C Inderal C Date:11/03/97ISR Number: 3028004-4Report Type:Periodic Company Report #US97071576A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 5.00 MG DAILY Dysarthria Professional PO 3 MON Lethargy Carbamazepine C Tremor Calcium Carbonate C Lorazepam C Levothyroxine C Date:11/03/97ISR Number: 3028005-6Report Type:Periodic Company Report #US97071789A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS 20.00 MG 1/ Dystonia Professional Heroin C Date:11/03/97ISR Number: 3028007-XReport Type:Periodic Company Report #UA97071816A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Paxil C Artane C Monopril C Date:11/03/97ISR Number: 3028010-XReport Type:Periodic Company Report #US97071828A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO 2 MON Zoloft C Date:11/03/97ISR Number: 3028012-3Report Type:Periodic Company Report #US97071831A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 40.00 TA PO Overdose Professional Company Representative 24-Jun-2005 12:19 PM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028014-7Report Type:Periodic Company Report #US97071837A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 5.00 MG Decreased Professional DAILY PO 11 DAY Company Clozaril C Representative Depakote C Date:11/03/97ISR Number: 3028016-0Report Type:Periodic Company Report #US97071840A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Discolouration Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Benadryl C Zantac C Klonopin C Date:11/03/97ISR Number: 3028019-6Report Type:Periodic Company Report #US97071846A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa PS ORAL 10.00 MG Lethargy Professional DAILY PO 3 MON Sedation Humalog C Humulin U C Date:11/03/97ISR Number: 3028021-4Report Type:Periodic Company Report #UA97071861A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 6 WK Trazodone C Clonazepam C Buspar C Date:11/03/97ISR Number: 3028023-8Report Type:Periodic Company Report #US97071864A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3028025-1Report Type:Periodic Company Report #US97072005A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Haldol C Ativan C Diazepam C Apap C 24-Jun-2005 12:19 PM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maalox C Milk Of Magnesia C Date:11/03/97ISR Number: 3028027-5Report Type:Periodic Company Report #US97072020A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa PS ORAL 10.00 MG Increased Professional DAILY PO Date:11/03/97ISR Number: 3028030-5Report Type:Periodic Company Report #US97072044A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 10 DAY Klonopin C Trazodone C Date:11/03/97ISR Number: 3028032-9Report Type:Periodic Company Report #US97072047A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Date:11/03/97ISR Number: 3028033-0Report Type:Periodic Company Report #US97072050A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Consumer Zyprexa PS ORAL 5.00 MG DAILY Dermatitis PO Xanax C Date:11/03/97ISR Number: 3028034-2Report Type:Periodic Company Report #US97072053A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS ORAL 2.5 MG DAILY Syncope Professional PO Date:11/03/97ISR Number: 3028036-6Report Type:Periodic Company Report #US9702056A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 5.00 MG DAILY PO Claritin C 24-Jun-2005 12:19 PM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028038-XReport Type:Periodic Company Report #US97072059A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Consumer Zyprexa PS 4 MON Cogentin C Lithium C Date:11/03/97ISR Number: 3028040-8Report Type:Periodic Company Report #US97072062A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Depakote C Klonopin C Micro-K C Thiazides C Diuretic C Date:11/03/97ISR Number: 3028041-XReport Type:Periodic Company Report #US97072068A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Cephalexin C Date:11/03/97ISR Number: 3028043-3Report Type:Periodic Company Report #US97072080A Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apnoea Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO Iron C Atrovent C Vasotec C Valproic Acid C Date:11/03/97ISR Number: 3028045-7Report Type:Periodic Company Report #US97072089A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa PS ORAL 20.00 MG Delusional Perception Health DAILY PO 3 WK Professional Date:11/03/97ISR Number: 3028046-9Report Type:Periodic Company Report #US97072098A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 10.00 MG Pharyngolaryngeal Pain DAILY PO 6 WK Lithium C Lamictal C 24-Jun-2005 12:19 PM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028048-2Report Type:Periodic Company Report #US97072104A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Date:11/03/97ISR Number: 3028050-0Report Type:Periodic Company Report #US97072116A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Health Zyprexa PS Lethargy Professional Date:11/03/97ISR Number: 3028051-2Report Type:Periodic Company Report #US97072119A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Prolixin C Paxil C Voltaren C Progesterone C Hydrodiuril C Date:11/03/97ISR Number: 3028053-6Report Type:Periodic Company Report #US97072308A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataplexy Health Zyprexa PS ORAL 10.00 MG Hallucination Professional DAILY PO Rapid Eye Movements Sleep Abnormal Date:11/03/97ISR Number: 3028054-8Report Type:Periodic Company Report #US97072311A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 10.00 MG Apathy Health DAILY PO Sedation Professional Inderal C Weight Increased Date:11/03/97ISR Number: 3028055-XReport Type:Periodic Company Report #US97072317A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Ritalin C Depakene C 24-Jun-2005 12:19 PM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028057-3Report Type:Periodic Company Report #US97072350A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Health Zyprexa PS ORAL 5.00 MG DAILY Face Oedema Professional PO 1 DAY Tongue Oedema Biaxin C Asa C Trihexyphenidyl C Atrovent C Norvasc C Insulin C Zoloft C Date:11/03/97ISR Number: 3028059-7Report Type:Periodic Company Report #US97072773A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Other Depakote C Lasix C Potassium C Aspirin C Ambien C Amiodarone C Dilantin C Date:11/03/97ISR Number: 3028061-5Report Type:Periodic Company Report #US97072803A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Health Zyprexa PS ORAL 15.00 MG Tachyarrhythmia Professional DAILY PO Other Cogentin C Benadryl C Navane C Date:11/03/97ISR Number: 3028064-0Report Type:Periodic Company Report #US97072815A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Other Zyprexa PS ORAL 10.00 MG Therapeutic Response DAILY PO Unexpected Ativan C Xanax C Lopressor C Date:11/03/97ISR Number: 3028065-2Report Type:Periodic Company Report #US97072950A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Zyprexa PS ORAL 2.50 MG DAILY Lethargy Professional PO Muscle Rigidity Other Lotrel C Muscle Twitching Aspirin C Xalatan C Bromocriptine C 24-Jun-2005 12:19 PM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028068-8Report Type:Periodic Company Report #US97073034A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS 5.00 MG DAILY Oedema Professional Valproate Sodium C Weight Increased Company Phenelzine C Representative Date:11/03/97ISR Number: 3028073-1Report Type:Periodic Company Report #US97073037A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Depakote C Paxil C Date:11/03/97ISR Number: 3028076-7Report Type:Periodic Company Report #US97073061A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Date:11/03/97ISR Number: 3028080-9Report Type:Periodic Company Report #US97073082A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Health Zyprexa PS 5.00 MG DAILY Carpal Tunnel Syndrome Professional Valproate Sodium C Hypoaesthesia Company Alprazolam C Oedema Representative Fluoxetine C Paraesthesia Weight Increased Date:11/03/97ISR Number: 3028084-6Report Type:Periodic Company Report #US97073127A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028087-1Report Type:Periodic Company Report #US97073277A Age:45 YR Gender:Female I/FU:I Outcome PT Blood Creatine Phosphokinase Increased Confusional State Coordination Abnormal Hyperhidrosis Muscle Rigidity Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Posture Abnormal 24-Jun-2005 12:19 PM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 25.00 MG Professional DAILY PO Prozac C Cogentin C Lorazepam C Date:11/03/97ISR Number: 3028090-1Report Type:Periodic Company Report #US97073295A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Buccoglossal Syndrome Consumer Zyprexa PS ORAL 20.00 MG DAILY PO Benztropine C Date:11/03/97ISR Number: 3028093-7Report Type:Periodic Company Report #US97073307A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Attention Health Zyprexa PS ORAL 20.00 MG Deficit/Hyperactivity Professional DAILY PO 1 WK Disorder Haldol C Symmetrel C Date:11/03/97ISR Number: 3028096-2Report Type:Periodic Company Report #US97073313A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Prolixin C Representative Ativan C Benadryl C Date:11/03/97ISR Number: 3028098-6Report Type:Periodic Company Report #US97073316A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Health Zyprexa PS ORAL 5.00 MG DAILY Visual Disturbance Professional PO Sertraline C Estradiol C Date:11/03/97ISR Number: 3028100-1Report Type:Periodic Company Report #US97073322A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional Haloperidol Company Decanoate C Representative Cogentin C Klonopin C Inderal C 24-Jun-2005 12:19 PM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028102-5Report Type:Periodic Company Report #US97073328A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 12.5 MG DAILY Syndrome Professional PO Pyrexia Sepsis Urinary Tract Infection Date:11/03/97ISR Number: 3028104-9Report Type:Periodic Company Report #US97073331A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Zyprexa PS ORAL 12.50 MG DAILY PO Risperdal C Ativan C Date:11/03/97ISR Number: 3028105-0Report Type:Periodic Company Report #US97073337A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS ORAL 10.00 MG Medication Error DAILY PO Speech Disorder Levothroid C Thinking Abnormal Chlorthalidone C Potassium C Lopressor C Date:11/03/97ISR Number: 3028107-4Report Type:Periodic Company Report #US97073346A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asperger'S Disorder Health Zyprexa PS ORAL 10.00 MG Fatigue Professional DAILY PO 14 WK Hyperhidrosis Guanfacine C Hypersomnia Increased Appetite Weight Increased Date:11/03/97ISR Number: 3028109-8Report Type:Periodic Company Report #US97073355A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Zyprexa PS ORAL 15.00 MG Phosphatase Increased Professional DAILY PO Blood Lactate Glyburide C Dehydrogenase Increased Gamma-Glutamyltransferase Increased 24-Jun-2005 12:19 PM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028110-4Report Type:Periodic Company Report #US97073394A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Zyprexa PS ORAL 10.00 MG Hallucination Health 2/DAY PO 5 MON Weight Decreased Professional Antibiotics C Weight Increased Sertraline C Doxazosin C Date:11/03/97ISR Number: 3028114-1Report Type:Periodic Company Report #US97073547A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 15.00 MG Mood Swings Health DAILY PO Professional Serzone C Date:11/03/97ISR Number: 3028116-5Report Type:Periodic Company Report #US97073577A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 1 WK Clozaril C Date:11/03/97ISR Number: 3028119-0Report Type:Periodic Company Report #US97073583A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 2 MON Paxil C Date:11/03/97ISR Number: 3028121-9Report Type:Periodic Company Report #US97073601A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028124-4Report Type:Periodic Company Report #US97073604A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Company Zyprexa PS ORAL 5.00 MG DAILY Sedation Representative PO 3 WK Urinary Retention Synthroid C Date:11/03/97ISR Number: 3028127-XReport Type:Periodic Company Report #US97073613A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL PO 1 MON Condition Aggravated Professional Prozac C 24-Jun-2005 12:19 PM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028129-3Report Type:Periodic Company Report #US97073814A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 5.00 MG DAILY Abnormal Professional PO 2 WK Weight Increased Lithium C Date:11/03/97ISR Number: 3028131-1Report Type:Periodic Company Report #US97073820A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 1 MON Valproate Sodium C Fluvoxamine C Clonazepam C Diphenhydramine C Lorazepam C Ibuprofen C Chlorpromazine C Date:11/03/97ISR Number: 3028134-7Report Type:Periodic Company Report #US97073823A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Consumer Zyprexa PS ORAL 10.00 MG Nervousness Health DAILY PO Professional Date:11/03/97ISR Number: 3028137-2Report Type:Periodic Company Report #US97074009A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 10.00 MG Skin Striae DAILY PO 2 MON Weight Increased Date:11/03/97ISR Number: 3028140-2Report Type:Periodic Company Report #US97074015A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Consumer Zyprexa PS Date:11/03/97ISR Number: 3028142-6Report Type:Periodic Company Report #US97074021A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Oxycodone And Acetaminofen C 24-Jun-2005 12:19 PM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028613-2Report Type:Periodic Company Report #US970838353A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Xanax C Date:11/03/97ISR Number: 3028616-8Report Type:Periodic Company Report #US97083859A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Klonopin C Date:11/03/97ISR Number: 3028618-1Report Type:Periodic Company Report #US97083871A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Health Zyprexa PS ORAL 10.00 MG Tardive Dyskinesia Professional DAILY PO Artane C Paxil C Vitamin E C Date:11/03/97ISR Number: 3028620-XReport Type:Periodic Company Report #US97083850A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa PS ORAL 20.00 MG Glycosuria Professional DAILY PO Haematuria Date:11/03/97ISR Number: 3028621-1Report Type:Periodic Company Report #US97083679A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 5.00 MG DAILY Fatigue Professional PO Lung Infiltration Prozac SS Pyrexia Date:11/03/97ISR Number: 3028623-5Report Type:Periodic Company Report #US97083808A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS Dyskinesia Professional Cardura C Restlessness Company Representative 24-Jun-2005 12:19 PM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028625-9Report Type:Periodic Company Report #US97083823A Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 20.00 MG Paranoia Professional DALIY PO Thioridazine C Date:11/03/97ISR Number: 3028627-2Report Type:Periodic Company Report #US97083829A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 10.00 MG Pain Of Skin DAILY PO 1 WK Synthroid C Date:11/03/97ISR Number: 3028628-4Report Type:Periodic Company Report #US97083847A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 12.50 MG DAILY PO Klonopin C Date:11/03/97ISR Number: 3028629-6Report Type:Periodic Company Report #US97083619A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myalgia Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 6 WK Depakote C Xanax C Synthroid C Date:11/03/97ISR Number: 3028632-6Report Type:Periodic Company Report #US97083622A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 2 WK Professional Prozac SS ORAL 80.00 MG DAILY PO Dalmane C Xanax C Date:11/03/97ISR Number: 3028634-XReport Type:Periodic Company Report #US97083508A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Zyprexa PS ORAL 10.00 MG Dysphagia Health DAILY PO Muscle Rigidity Professional 24-Jun-2005 12:19 PM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028637-5Report Type:Periodic Company Report #US97083490A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS 2 MON Oedema Peripheral Professional Date:11/03/97ISR Number: 3028640-5Report Type:Periodic Company Report #US97083232A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 20.00 MG Weight Increased DAILY PO Date:11/03/97ISR Number: 3028642-9Report Type:Periodic Company Report #US97083247A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Weight Increased Professional DAILY Date:11/03/97ISR Number: 3028645-4Report Type:Periodic Company Report #US97083253A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Klonopin C Representative Depakote C Levoxyl C Date:11/03/97ISR Number: 3028648-XReport Type:Periodic Company Report #US97083478A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urticaria Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 5 WK Stelazine C Klonopin C Date:11/03/97ISR Number: 3028650-8Report Type:Periodic Company Report #US97082890A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apraxia Consumer Zyprexa PS ORAL 2.5 MG DAILY Muscle Rigidity PO Kemadrin C Rigidity C Sinemet C Date:11/03/97ISR Number: 3028652-1Report Type:Periodic Company Report #US97082893A Age:5 YR Gender:Male I/FU:I Outcome PT Accidental Exposure Agitation 24-Jun-2005 12:19 PM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 14 DAY Zyrtec C Flovent C Date:11/03/97ISR Number: 3028655-7Report Type:Periodic Company Report #US97082896A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 2 WK Depakote C Date:11/03/97ISR Number: 3028658-2Report Type:Periodic Company Report #US97083109A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Company Representative Date:11/03/97ISR Number: 3028661-2Report Type:Periodic Company Report #US97083148A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Representative Date:11/03/97ISR Number: 3028664-8Report Type:Periodic Company Report #US97082779A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration International Normalised Health Zyprexa PS Ratio Increased Professional Prozac SS 100.00 MG DAILY Coumadin C 2.5 MG DAILY 6 DAY Coumadin C 5.00 MG 1/D 1 DAY Date:11/03/97ISR Number: 3028667-3Report Type:Periodic Company Report #US97082869A Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Health Zyprexa PS ORAL 10.00 MG Unexpected Professional DAILY PO 6 WK Paxil C 24-Jun-2005 12:19 PM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028669-7Report Type:Periodic Company Report #US97082887A Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Date:11/03/97ISR Number: 3028672-7Report Type:Periodic Company Report #US97082581A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS 5.00 MG 30 DAY Professional Risperdal C Company Benadryl C Representative Date:11/03/97ISR Number: 3028676-4Report Type:Periodic Company Report #US97082623A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lactation Disorder Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 WK Company Representative Date:11/03/97ISR Number: 3028677-6Report Type:Periodic Company Report #US97082575A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 12.5 MG DAILY Professional PO 2 MON Klonopin C Luvox C Date:11/03/97ISR Number: 3028679-XReport Type:Periodic Company Report #US97082578A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3028680-6Report Type:Periodic Company Report #US97082563A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Trilafon C Ssri C Ativan C 24-Jun-2005 12:19 PM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028681-8Report Type:Periodic Company Report #US97082569A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS 5.00 MG DAILY Professional Trilafon C Prozac C Cogentin C Clonidine C Date:11/03/97ISR Number: 3028683-1Report Type:Periodic Company Report #US97082572A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 3 MON Synthroid C Multivitamin C Date:11/03/97ISR Number: 3028685-5Report Type:Periodic Company Report #US97082560A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Depakote C Date:11/03/97ISR Number: 3028687-9Report Type:Periodic Company Report #US97082335A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disorientation Consumer Zyprexa PS ORAL 5.00 MG DAILY Fatigue Health PO Flashback Professional Synthroid C Hepatic Function Abnormal Depakote C Liver Function Test Abnormal Date:11/03/97ISR Number: 3028689-2Report Type:Periodic Company Report #US97082446A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS ORAL 20.00 MG Sedation Professional DAILY PO Weight Increased Date:11/03/97ISR Number: 3028691-0Report Type:Periodic Company Report #US97082449A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperthermia Malignant Health Zyprexa PS ORAL 12.5 MG DAILY Professional PO Cardizem C Lasix C Sinemet C Eldepryl C Parlodel C 24-Jun-2005 12:19 PM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ditropan C Date:11/03/97ISR Number: 3028693-4Report Type:Periodic Company Report #US97082455A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Migraine Consumer Zyprexa PS ORAL 10.00 MG Paraesthesia DAILY PO 2 MON Weight Increased Prozac C Clonidine C Date:11/03/97ISR Number: 3028696-XReport Type:Periodic Company Report #US97082458A Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Posture Abnormal Consumer Zyprexa PS ORAL 2.5 MG DAILY Sedation PO 2 WK Paxil C Sinemet C Amantadine C Date:11/03/97ISR Number: 3028697-1Report Type:Periodic Company Report #US97082476A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Health Zyprexa PS ORAL 15.00 MG PO Hyponatraemia Professional Klonopin C Inappropriate Company Depakote C Antidiuretic Hormone Representative Secretion Date:11/03/97ISR Number: 3028699-5Report Type:Periodic Company Report #US97082059A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS ORAL 10.00 MG Depression DAILY PO Muscle Rigidity Antibiotic C Tremor L-Dopa C Paxil C Date:11/03/97ISR Number: 3028700-9Report Type:Periodic Company Report #US97082071A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Weight Increased Professional Date:11/03/97ISR Number: 3028703-4Report Type:Periodic Company Report #US97082074A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 24-Jun-2005 12:19 PM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028705-8Report Type:Periodic Company Report #US97082077A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 4 MON Demulen C Xanax C Spironolactone C Date:11/03/97ISR Number: 3028707-1Report Type:Periodic Company Report #US97082083A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Sinemet C Date:11/03/97ISR Number: 3028708-3Report Type:Periodic Company Report #US97082119A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Prozac PS ORAL 20.00 MG Syncope DAILY PO Zyprexa SS ORAL 10.00 MG DAILY PO 5 MON Lithium C Date:11/03/97ISR Number: 3028710-1Report Type:Periodic Company Report #US97082272A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Anafranil C Date:11/03/97ISR Number: 3028712-5Report Type:Periodic Company Report #US97082278A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Zyprexa PS 10.00 MG Professional DAILY Octreotide C Insulin C Albuterol C Sertraline C Levothyroxine C Lansoprazole C Date:11/03/97ISR Number: 3028713-7Report Type:Periodic Company Report #US97082284A Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS 6 WK Positive Professional Buspar C Arthritis 24-Jun-2005 12:19 PM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028715-0Report Type:Periodic Company Report #US97082299A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS ORAL PO Professional Gentamicin C Vancomycin C Serax C Date:11/03/97ISR Number: 3028717-4Report Type:Periodic Company Report #US97081849A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pre-Existing Condition Health Zyprexa PS ORAL 5.00 MG DAILY Improved Professional PO 1 MON Therapeutic Response Prozac C Unexpected Date:11/03/97ISR Number: 3028719-8Report Type:Periodic Company Report #US97081855A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO 3 WK Lithium C Lorazepam C Date:11/03/97ISR Number: 3028721-6Report Type:Periodic Company Report #US97081858A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS 10 DAY Nervousness Professional Tylenol C Date:11/03/97ISR Number: 3028724-1Report Type:Periodic Company Report #US97081861A Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 5.00 MG DAILY Sedation Professional PO Date:11/03/97ISR Number: 3028726-5Report Type:Periodic Company Report #US97081522A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Other Zyprexa PS Arthritis Buspirone C Weight Increased Date:11/03/97ISR Number: 3028728-9Report Type:Periodic Company Report #US97081588A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Consumer Zyprexa PS ORAL 10.00 MG Tinnitus DAILY PO 2 WK Tremor Remerom C 24-Jun-2005 12:19 PM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Florinef C Bentyl C Date:11/03/97ISR Number: 3028730-7Report Type:Periodic Company Report #US97081594A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatomegaly Health Zyprexa PS ORAL 10.00 MG Oedema Peripheral Professional DAILY PO Weight Increased Impramine C Date:11/03/97ISR Number: 3028732-0Report Type:Periodic Company Report #US97081597A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa PS 15.00 MG Parkinsonian Gait Health DAILY Vertigo Professional Prozac SS Klonopin C Premarin C Date:11/03/97ISR Number: 3028734-4Report Type:Periodic Company Report #US97081657A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Consumer Zyprexa PS ORAL 10.00 MG Medication Error DAILY PO 10 DAY Date:11/03/97ISR Number: 3028736-8Report Type:Periodic Company Report #US97081660A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028740-XReport Type:Periodic Company Report #US97081822A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO Cogentin C Date:11/03/97ISR Number: 3033612-0Report Type:Periodic Company Report #US97095110A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033615-6Report Type:Periodic Company Report #US97095113A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Skin Disorder Professional DAILY Weight Increased Lithium C Date:11/03/97ISR Number: 3033616-8Report Type:Periodic Company Report #US97095119A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Skin Disorder Professional DAILY PO Weight Increased Lithium C Bentyl C Date:11/03/97ISR Number: 3033618-1Report Type:Periodic Company Report #US97095137A Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 6 WK Sinemet C Sinequan C Levsinex C Acupril C Inderal La C Permax C Propulsid C Ambien C Date:11/03/97ISR Number: 3033620-XReport Type:Periodic Company Report #US97095170A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO Decreased Date:11/03/97ISR Number: 3033622-3Report Type:Periodic Company Report #US97095173A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Acetaminophen C Naprosyn C Klonopin C Entex La C Vancenase C Benadryl C Depakote C Triple Antibiotic Ointment C 24-Jun-2005 12:19 PM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033623-5Report Type:Periodic Company Report #US97095182A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033624-7Report Type:Periodic Company Report #US97095413A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033626-0Report Type:Periodic Company Report #US97095422A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain In Extremity Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Date:11/03/97ISR Number: 3033627-2Report Type:Periodic Company Report #US97095431A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Health Zyprexa PS ORAL 10.00 MG Hypotension Professional DAILY PO Medication Error Date:11/03/97ISR Number: 3033629-6Report Type:Periodic Company Report #US97095440A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Pain Health Zyprexa PS ORAL 5.00 MG Nausea Professional DAILY PO Date:11/03/97ISR Number: 3033630-2Report Type:Periodic Company Report #US97095452A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 10.00 MG PO Professional Date:11/03/97ISR Number: 3033632-6Report Type:Periodic Company Report #US97095689A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 7.50 MG Libido Decreased Health DAILY PO Sedation Professional Neurontin C Weight Increased Sunthroid C 24-Jun-2005 12:19 PM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033634-XReport Type:Periodic Company Report #US97095698A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG Skin Discolouration DAILY PO Neurontin C Tegretol C Effexor C Nortriptyline C Date:11/03/97ISR Number: 3033635-1Report Type:Periodic Company Report #US97095701A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 3 MON Depakote C Date:11/03/97ISR Number: 3033637-5Report Type:Periodic Company Report #US97095731A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS ORAL 10.00 MG Muscle Rigidity Professional DAILY PO 1 MON Tachycardia Sertraline C Tetany Synthroid C Torticollis Tremor Date:11/03/97ISR Number: 3033638-7Report Type:Periodic Company Report #US97095737A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 2 WK Date:11/03/97ISR Number: 3033640-5Report Type:Periodic Company Report #US97095755A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Health Zyprexa PS ORAL 2.5 MG DAILY Professional PO 1 WK Date:11/03/97ISR Number: 3033641-7Report Type:Periodic Company Report #US97100175A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Health Zyprexa PS ORAL 7.5 MG DAILY Hyperhidrosis Professional PO 24-Jun-2005 12:19 PM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033643-0Report Type:Periodic Company Report #US97100181A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Consumer Zyprexa PS ORAL 2.5 MG DAILY Increased PO Vasotec C Depakote C Date:11/03/97ISR Number: 3033644-2Report Type:Periodic Company Report #US97100205A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Zyprexa PS ORAL 10.MG DAILY Retinal Oedema Health PO 3 MON Professional Date:11/03/97ISR Number: 3033646-6Report Type:Periodic Company Report #US97100214A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Company Zyprexa PS ORAL 7.5 MG DAILY Hypersomnia Representative PO 4 MON Date:11/03/97ISR Number: 3033647-8Report Type:Periodic Company Report #US97100217A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neck Pain Consumer Zyprexa PS ORAL 20.00 MG DAILY; PO Date:11/03/97ISR Number: 3033649-1Report Type:Periodic Company Report #US97100223A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 7.5 MG DAILY Sedation Professional PO Weight Increased Date:11/03/97ISR Number: 3033650-8Report Type:Periodic Company Report #US97100232A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Health Zyprexa PS ORAL 10.MG DAILY Inversion Professional PO Tachycardia Date:11/03/97ISR Number: 3033652-1Report Type:Periodic Company Report #US97100466A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 5.0MG DAILY Chills Professional PO Sedation Luvox C 50.MG 002/DAY Vomiting Benztropine C 1.00 MG 2/D Risperdal C 1.00 MG 3/D 24-Jun-2005 12:19 PM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033653-3Report Type:Periodic Company Report #US97100514A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 9 MON Lithium C Depakote C Date:11/03/97ISR Number: 3033655-7Report Type:Periodic Company Report #US97100538A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Scoliosis Consumer Zyprexa PS 5 MON Vision Blurred Date:11/03/97ISR Number: 3033656-9Report Type:Periodic Company Report #US97100562A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyporeflexia Health Zyprexa PS ORAL 15.00 MG Professional DAILY; PO Company Paxil C Representative Ativan C Cogentin C Date:11/03/97ISR Number: 3033658-2Report Type:Periodic Company Report #US97100721A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Galactorrhoea Professional Company Representative Date:11/03/97ISR Number: 3033659-4Report Type:Periodic Company Report #US97100733A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS 2 MON Nasopharyngitis Health Lithium C Pallor Professional Date:11/03/97ISR Number: 3033661-2Report Type:Periodic Company Report #US97100736A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intermittent Claudication Health Zyprexa PS ORAL 10.00MG DAILY Pain In Extremity Professional PO Ativan C 24-Jun-2005 12:19 PM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033662-4Report Type:Periodic Company Report #US97100745A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 5.00 MG Professional DAILY;PO 4 DAY Company Trilafon C Representative Date:11/03/97ISR Number: 3033664-8Report Type:Periodic Company Report #US97100760A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Health Zyprexa PS Dysphoria Professional Prolixin C Sedation Date:11/03/97ISR Number: 3033665-XReport Type:Periodic Company Report #US97100763A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Health Zyprexa PS ORAL 10.00MG Hypoaesthesia Professional DAILY; PO Company Representative Date:11/03/97ISR Number: 3033667-3Report Type:Periodic Company Report #US97100919A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 2.50 MG Weight Decreased DAILY; PO Zoloft C Date:11/03/97ISR Number: 3033668-5Report Type:Periodic Company Report #US97100967A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Consumer Zyprexa PS ORAL PO 3 MON Date:11/03/97ISR Number: 3033670-3Report Type:Periodic Company Report #US97100982A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 25.00 MG Professional DAILY;PO 2 MON Paxil C Date:11/03/97ISR Number: 3033672-7Report Type:Periodic Company Report #US97100994A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laryngospasm Health Zyprexa PS SUBCUTANEOUS 20.00 MG Professional DAILY SC Cogentin C Ativan C 24-Jun-2005 12:19 PM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033674-0Report Type:Periodic Company Report #US97101000A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 15.00MG DAILY Liver Function Test Professional PO Abnormal Anafranil C Vomiting Prozac C Date:11/03/97ISR Number: 3033675-2Report Type:Periodic Company Report #US97101012A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 5.00 MG 2/DAY 2 MON Professional Date:11/03/97ISR Number: 3033676-4Report Type:Periodic Company Report #US97101018A Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Zyprexa PS ORAL 2.50 MG DAILY Professional PO Date:11/03/97ISR Number: 3033678-8Report Type:Periodic Company Report #US97101021A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Rigidity Consumer Zyprexa PS ORAL 10.00 MG Back Pain DAILY PO Blepharospasm Muscle Rigidity Muscle Spasms Tongue Spasm Date:11/03/97ISR Number: 3033680-6Report Type:Periodic Company Report #US97101048A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 3 MON Insulin C Cogentin C Date:11/03/97ISR Number: 3033681-8Report Type:Periodic Company Report #US97101051A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 20.00 MG Professional Date:11/03/97ISR Number: 3033682-XReport Type:Periodic Company Report #US97101060A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Akathisia Health Professional 24-Jun-2005 12:19 PM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 10.00 MG DAILY PO 1 YR Prozac SS 40.00 MG DAILY Remeron C Date:11/03/97ISR Number: 3033684-3Report Type:Periodic Company Report #US95010928A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Study Zyprexa PS ORAL 20.00 MG Pneumonia Health DAILY PO Productive Cough Professional Vitamin C C Pyrexia Dietary Supplement C Vitamin B C Date:11/03/97ISR Number: 3033686-7Report Type:Periodic Company Report #US97032416A Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Hip Fracture Health PO Disability Professional Bumex C Risperdal C Hydrocortisone C Milk Of Magnesia C Tylenol C Ibuprofen C Aspirin C Zestril C Date:11/03/97ISR Number: 3033687-9Report Type:Periodic Company Report #US97042017A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Depressed Mood Health PO Depression Professional Prozac C Hallucination, Auditory Ativan C Stress Suicidal Ideation Date:11/03/97ISR Number: 3033689-2Report Type:Periodic Company Report #US97054300A Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Health PO Professional Asa C Vitamn B 12 C Folic Acid C Lactulose C Surfak C 24-Jun-2005 12:19 PM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033690-9Report Type:Periodic Company Report #US97064384A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Study Zyprexa PS Initial or Prolonged Overdose Health Congentin C Professional Extrapyramidal Syndrome C Date:11/03/97ISR Number: 3033692-2Report Type:Periodic Company Report #US97065605A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Fall Health PO Sleep Disorder Professional Ativan C Date:11/03/97ISR Number: 3033693-4Report Type:Periodic Company Report #US97070175A Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anhedonia Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Depression Health PO Professional Date:11/03/97ISR Number: 3033695-8Report Type:Periodic Company Report #US96123358A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Zyprexa PS ORAL 20 MG DAILY Decreased Professional PO 2 WK Depakote C Oxybutynin C Docusate C Date:11/03/97ISR Number: 3033697-1Report Type:Periodic Company Report #US97022707A Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa PS 10 MG DAILY 2 WK Pyrexia Professional Depakote C Viral Infection Company Representative Date:11/03/97ISR Number: 3033698-3Report Type:Periodic Company Report #US97031054A Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Zyprexa PS ORAL 10 MG 3/DAY Haemoglobin Decreased Professional PO Hyperglycaemia Trilafon C Hypokalaemia Novolin 70/30 C Humulin R C 24-Jun-2005 12:19 PM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033700-9Report Type:Periodic Company Report #US97033847A Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rectal Haemorrhage Health Zyprexa PS ORAL 15 MG DAILY Professional PO Depakote C Wellbutrin C Dynacin C Date:11/03/97ISR Number: 3033701-0Report Type:Periodic Company Report #US97040622A Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS ORAL 7.5 MG DAILY Initial or Prolonged Headache Professional PO Hepatic Function Abnormal Hepatitis Pyrexia Vomiting Date:11/03/97ISR Number: 3033702-2Report Type:Periodic Company Report #US97043202A Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Zyprexa PS ORAL 5 MG DAILY PO 4 DAY Professional Company Representative Date:11/03/97ISR Number: 3033704-6Report Type:Periodic Company Report #US97043208A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS ORAL 30 MG DAILY Coordination Abnormal Professional PO Drug Interaction Company Benadryl C Sedation Representative Depakote C Navane C Luvox C Eskalith Cr C Ativan C Date:11/03/97ISR Number: 3033705-8Report Type:Periodic Company Report #US97045965A Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Zyprexa PS ORAL 100 MG 1 PO Initial or Prolonged Overdose Professional Other Date:11/03/97ISR Number: 3033707-1Report Type:Periodic Company Report #US97054504A Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Zyprexa PS ORAL 50 MG DAILY Professional PO 24-Jun-2005 12:19 PM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol C Risperdal C Luvox C Lithium C Date:11/03/97ISR Number: 3033709-5Report Type:Periodic Company Report #US97054936A Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Prozac PS 20 MG Initial or Prolonged Depressed Level Of Professional Zyprexa SS 10 MG Other Consciousness Required Overdose Intervention to Prevent Permanent Impairment/Damage Date:11/03/97ISR Number: 3033710-1Report Type:Periodic Company Report #US97062497A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Professional PO Other Carbamazepine C Sertraline C Date:11/03/97ISR Number: 3033712-5Report Type:Periodic Company Report #US97064000A Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Culture Positive Health Zyprexa PS ORAL 10 MG 2/DAY Initial or Prolonged Pyrexia Professional PO Lorazepam C Date:11/03/97ISR Number: 3033832-5Report Type:Periodic Company Report #US97093655A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Health Zyprexa PS ORAL 500 MG DAILY Professional PO Date:11/03/97ISR Number: 3033834-9Report Type:Periodic Company Report #US97093670A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Representative 24-Jun-2005 12:19 PM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033909-4Report Type:Periodic Company Report #US97093814A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Depakote C Date:11/03/97ISR Number: 3033911-2Report Type:Periodic Company Report #US97094000A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS ORAL 5.00 MG DAILY PO Effexor C Date:11/03/97ISR Number: 3033914-8Report Type:Periodic Company Report #US97094009A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Zyprexa PS ORAL 2.5 MG DAILY Weight Increased PO Zoloft C Date:11/03/97ISR Number: 3033917-3Report Type:Periodic Company Report #US97094012A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS ORAL 10.00 MG Anger DAILY PO Euphoric Mood Hypotension Date:11/03/97ISR Number: 3033920-3Report Type:Periodic Company Report #US97094024A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 20.00 MG Abnormal Professional DAILY PO Date:11/03/97ISR Number: 3033923-9Report Type:Periodic Company Report #US97094036A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL PO 2 MON Professional Date:11/03/97ISR Number: 3033927-6Report Type:Periodic Company Report #US97094072A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional 24-Jun-2005 12:19 PM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033930-6Report Type:Periodic Company Report #US97094078A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Health Zyprexa PS ORAL 10.00 MG PO Sedation Professional 2/DAY PO 6 MON Date:11/03/97ISR Number: 3033933-1Report Type:Periodic Company Report #US97094081A Age:65 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS Dysphagia Professional Company Representative Date:11/03/97ISR Number: 3033935-5Report Type:Periodic Company Report #US97094084A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cor Pulmonale Health Zyprexa PS 6 WK Pulmonary Hypertension Professional Clozaril C Sleep Apnoea Syndrome Company Representative Date:11/03/97ISR Number: 3033938-0Report Type:Periodic Company Report #US97094252A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Cogentin C Date:11/03/97ISR Number: 3033941-0Report Type:Periodic Company Report #US97094258A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enzyme Abnormality Health Zyprexa PS ORAL 12.50 MG Haematemesis Professional DAILY PO Zoloft C Asa C Date:11/03/97ISR Number: 3033943-4Report Type:Periodic Company Report #US97094264A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 5.00 MG DAILY Dysphagia Professional PO Klonopin C Date:11/03/97ISR Number: 3033947-1Report Type:Periodic Company Report #US97094321A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain In Extremity Health Zyprexa PS ORAL 5.00 MG DAILY Paraesthesia Professional PO 24-Jun-2005 12:19 PM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Norvasc C Date:11/03/97ISR Number: 3033951-3Report Type:Periodic Company Report #US97094324A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Health Zyprexa PS ORAL 10.00 MG Muscle Twitching Professional DAILY PO 4 MON Company Representative Date:11/03/97ISR Number: 3033953-7Report Type:Periodic Company Report #US97094327A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Health Zyprexa PS ORAL 10.00 MG PO Professional DAILY 3 MON Company Representative Date:11/03/97ISR Number: 3033957-4Report Type:Periodic Company Report #US97094330A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 10.00 MG Hallucination, Auditory Professional DAILY PO Tegretol C Synthroid C Klonopin C Zoloft C Date:11/03/97ISR Number: 3033960-4Report Type:Periodic Company Report #US97094336A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Consumer Zyprexa PS ORAL 10.00 MG Hypersomnia DAILY PO 2 MON Sedation Paxil C Vomiting Oxazepam C Date:11/03/97ISR Number: 3033964-1Report Type:Periodic Company Report #US97094540A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 15.00 MG Jaw Disorder DAILY PO Neurosis Palpitations Restless Legs Syndrome Tongue Oedema 24-Jun-2005 12:19 PM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033967-7Report Type:Periodic Company Report #US97094564A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conjunctival Hyperaemia Health Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred Professional PO Date:11/03/97ISR Number: 3033970-7Report Type:Periodic Company Report #US97094597A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Cogentin C Sorbitol C Norvasc C Asa C Depakote C Flagyl C Klonopin C Ativan C Tylenol C Augmentin C Cardura C Duragesic C Humulin R C Date:11/03/97ISR Number: 3033972-0Report Type:Periodic Company Report #US97094726A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033975-6Report Type:Periodic Company Report #US97094765A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Depakote C Effexor C Date:11/03/97ISR Number: 3033978-1Report Type:Periodic Company Report #US97094774A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 7.5 MG DAILY Professional PO Depakote C Cogentin C Lorazepam C Haldol Depot C 24-Jun-2005 12:19 PM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033980-XReport Type:Periodic Company Report #US97094846A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Haldol C Prozac C Depakote C Benadryl C Date:11/03/97ISR Number: 3033984-7Report Type:Periodic Company Report #US97094852A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Liver Function Test Professional DAILY PO Abnormal Amitriptyline C Hydrochlorothiazide With Triamterene C Premarin C Date:11/03/97ISR Number: 3033987-2Report Type:Periodic Company Report #US97094864A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033989-6Report Type:Periodic Company Report #US97094870A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Health Zyprexa PS ORAL 10.00 MG Exposure To Therapeutic Professional DAILYPO 2 MON Drugs Depakote C No Adverse Drug Effect Zoloft C Cogentin C Date:11/03/97ISR Number: 3033992-6Report Type:Periodic Company Report #US97094873A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Health Zyprexa PS Pyrexia Professional Company Representative Date:11/03/97ISR Number: 3033995-1Report Type:Periodic Company Report #US97094882A Age:38 YR Gender:Male I/FU:I Outcome PT Delusional Disorder, Unspecified Type Drug Ineffective Hallucination Hypomania 24-Jun-2005 12:19 PM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional 2/DAY PO Prolixin Decanoate C Prolixin C Klonopin C Date:11/03/97ISR Number: 3033998-7Report Type:Periodic Company Report #US97094894A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS ORAL 10.00 MG Pre-Existing Condition Professional DAILY PO 5 MON Improved Luvox C Weight Increased Tenex C Seldane C Propulsid C Prosom C Xanax C Anticholinergics C Date:11/03/97ISR Number: 3034001-5Report Type:Periodic Company Report #US97094900A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Psychiatric Symptom Professional Depakote C Date:11/03/97ISR Number: 3034003-9Report Type:Periodic Company Report #US97094906A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034006-4Report Type:Periodic Company Report #US97095074A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034010-6Report Type:Periodic Company Report #US97095077A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034012-XReport Type:Periodic Company Report #US97095080A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Of Relaxation Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Zestril C Aspirin C Date:11/03/97ISR Number: 3034014-3Report Type:Periodic Company Report #US97095083A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034016-7Report Type:Periodic Company Report #US97095101A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034017-9Report Type:Periodic Company Report #US97095104A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034019-2Report Type:Periodic Company Report #US97095107A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034098-2Report Type:Periodic Company Report #US97084921A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG PO 6 MON Professional Trazodone C Company Prozac C Representative Date:11/03/97ISR Number: 3034099-4Report Type:Periodic Company Report #US97084924A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 10.00 MG Professional Stelazine C Company Representative 24-Jun-2005 12:19 PM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034100-8Report Type:Periodic Company Report #US97084936A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG Weight Increased DAILY PO 1 MON Zoloft C Ativan C Date:11/03/97ISR Number: 3034101-XReport Type:Periodic Company Report #US97084939A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 15.00 MG Hallucination, Auditory Health DAILY PO Professional Mellaril C Cogentin C Larazepam C Date:11/03/97ISR Number: 3034102-1Report Type:Periodic Company Report #US97084945A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Zoloft C Cogentin C Depakote C Date:11/03/97ISR Number: 3034103-3Report Type:Periodic Company Report #US97084993A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Health Zyprexa PS ORAL 10.00 MG Malaise Professional DAILY PO Nausea Company Depakote C Representative Date:11/03/97ISR Number: 3034104-5Report Type:Periodic Company Report #US97085014A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3034105-7Report Type:Periodic Company Report #US97085017A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Cogentin C 24-Jun-2005 12:19 PM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034106-9Report Type:Periodic Company Report #US97085029A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS ORAL 10.00 MG Myalgia Health DAILY PO Pain Professional Nadolol C Weight Increased Estrogen C Medroxyprogesterone C Trihexyphenidyl C Fluoxetine C Date:11/03/97ISR Number: 3034107-0Report Type:Periodic Company Report #US97085041A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Swelling Professional DAILY PO Trilafon C Propranolol C Artane C Prozac C Ativan C Date:11/03/97ISR Number: 3034108-2Report Type:Periodic Company Report #US97085104A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Ativan C Date:11/03/97ISR Number: 3034109-4Report Type:Periodic Company Report #US97085113A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Other Zyprexa PS ORAL 10.00 MG DAILY PO Paxil C Depakote C Doxepin C Klonopin C Thyroid C Date:11/03/97ISR Number: 3034110-0Report Type:Periodic Company Report #US97085116A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Health Zyprexa PS ORAL 5.00 MG Drug Interaction Professional DAILY PO 4 DAY Extrapyramidal Disorder Sinemet C Fall Depakote C Gait Disturbance Haldol C Hypotension 24-Jun-2005 12:19 PM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034112-4Report Type:Periodic Company Report #US97085122A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3034113-6Report Type:Periodic Company Report #US97085125A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 10.00 MG Mydriasis Professional 2/DAY PO Paxil C Cogentin C Advil C Date:11/03/97ISR Number: 3034114-8Report Type:Periodic Company Report #US97085134A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 10.00 MG Abnormal Professional DAILY PO Metamucil C Cleocin T C Retin A C Date:11/03/97ISR Number: 3034115-XReport Type:Periodic Company Report #US97085137A Age:70 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Drug Ineffective Professional Pyrexia Sweating Fever Tremor Date:11/03/97ISR Number: 3034116-1Report Type:Periodic Company Report #US97085143A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Function Abnormal Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034117-3Report Type:Periodic Company Report #US97085152A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Consumer Zyprexa PS ORAL 5.00 MG DAILY Dermatitis Health PO Eye Irritation Professional Xanax C Headache Malaise Rhinorrhoea 24-Jun-2005 12:19 PM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034119-7Report Type:Periodic Company Report #US97085161A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 20.00 MG Oedema Peripheral Professional DAILY PO Depakote C Diazepam C Date:11/03/97ISR Number: 3034120-3Report Type:Periodic Company Report #US97085191A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034122-7Report Type:Periodic Company Report #US97085197A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034124-0Report Type:Periodic Company Report #US97085200A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034126-4Report Type:Periodic Company Report #US97085203A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034129-XReport Type:Periodic Company Report #US97085287A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 7.50 MG DAILY PO 2 MON Date:11/03/97ISR Number: 3034131-8Report Type:Periodic Company Report #US97085293A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 10.00 MG Oedema Peripheral Professional DAILY PO Depakote C Klonopin C 24-Jun-2005 12:19 PM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034133-1Report Type:Periodic Company Report #US97085299A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Consumer Zyprexa PS ORAL 5.00 MG DAILY Posture Abnormal Health PO 1 WK Professional Sinemet C Date:11/03/97ISR Number: 3034134-3Report Type:Periodic Company Report #US97085305A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 1 MON Professional Date:11/03/97ISR Number: 3034136-7Report Type:Periodic Company Report #US97085311A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS 10.00 MG UNK 1 MON Tardive Dyskinesia Professional Company Representative Date:11/03/97ISR Number: 3034138-0Report Type:Periodic Company Report #US97085314A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS 10.00 MG UNK 2 MON Professional Company Representative Date:11/03/97ISR Number: 3034140-9Report Type:Periodic Company Report #US97090229A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Function Disorder Consumer Zyprexa PS ORAL 15.00 MG Movement Disorder Health DAILY PO Nasal Discomfort Professional Date:11/03/97ISR Number: 3034142-2Report Type:Periodic Company Report #US97090466A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS 2 WK Professional Depakote C Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034144-6Report Type:Periodic Company Report #US97090637A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Health Zyprexa PS ORAL 5.00 MG UNK Medication Error Professional PO Date:11/03/97ISR Number: 3034147-1Report Type:Periodic Company Report #US97090826A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034149-5Report Type:Periodic Company Report #US97090835A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034151-3Report Type:Periodic Company Report #US97090838A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS ORAL 2.50 MG UNK Professional PO Date:11/03/97ISR Number: 3034153-7Report Type:Periodic Company Report #US97090841A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034156-2Report Type:Periodic Company Report #US97090844A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS ORAL 20.00 UNK PO Professional Date:11/03/97ISR Number: 3034158-6Report Type:Periodic Company Report #US97094810A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034161-6Report Type:Periodic Company Report #US97094789A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 24-Jun-2005 12:19 PM Page: 102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Lithium C Effexor C Buspar C Date:11/03/97ISR Number: 3034165-3Report Type:Periodic Company Report #US97094828A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 20.00 MG Liver Function Test Professional DAILY PO Abnormal Depakote C Buspar C Zoloft C Glucotrol C Date:11/03/97ISR Number: 3034168-9Report Type:Periodic Company Report #US97094837A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Paxil C Depakote C L-Thyroxine C Date:11/03/97ISR Number: 3034171-9Report Type:Periodic Company Report #US97094819A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 5.00 MG DAILY Liver Function Test Professional PO Abnormal Lithuim Carbonate C Cogentin C Vitamin E C Date:11/03/97ISR Number: 3034173-2Report Type:Periodic Company Report #US97093541A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 20.00 MG DAILY PO Date:11/03/97ISR Number: 3034177-XReport Type:Periodic Company Report #US97093544A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Consumer Zyprexa PS 10.00 MG Dizziness DAILY UNK Nausea Cozaar C Palpitations Lozol C Vision Blurred K-Dur C Lescol C Fosamax C Paxil C 24-Jun-2005 12:19 PM Page: 103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034564-XReport Type:Periodic Company Report #US97065587A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Professional PO 1 MON Company Representative Date:11/03/97ISR Number: 3034568-7Report Type:Periodic Company Report #US97065620A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Hyperglycaemia Professional PO 3 MON Lethargy Company Representative Date:11/03/97ISR Number: 3035318-0Report Type:Periodic Company Report #US97070103A Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS ORAL 25 MG DAILY Sedation Professional PO Date:11/03/97ISR Number: 3035320-9Report Type:Periodic Company Report #US96120745A Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Zyprexa PS UNKNOWN 10.00 MG Decreased Professional Florinef C White Blood Cell Count Company Xanax C Decreased Representative Tenormin C Prozac C Imdur C Synthroid C Premarin C Provera C Prinivil C Date:11/03/97ISR Number: 3035322-2Report Type:Periodic Company Report #US96121660A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphocyte Count Health Zyprexa PS ORAL 10.00 MG Increased Professional 2/DAY PO 4 DAY Neutropenia Sodium Valproate C Date:11/03/97ISR Number: 3035325-8Report Type:Periodic Company Report #US96122131A Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 24-Jun-2005 12:19 PM Page: 104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035327-1Report Type:Periodic Company Report #US96123949A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO Decreased Clozaril C Depakote C Date:11/03/97ISR Number: 3035330-1Report Type:Periodic Company Report #US97011504A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Date:11/03/97ISR Number: 3035332-5Report Type:Periodic Company Report #US97014924A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS Professional Clozaril C Company Depakote C Representative Cogentin C Date:11/03/97ISR Number: 3035333-7Report Type:Periodic Company Report #US97015014A Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 10.00 MG Decreased Professional DAILY PO Company Clonazepam C Representative Valproate Sodium C Lithium C Ssri C Date:11/03/97ISR Number: 3035335-0Report Type:Periodic Company Report #US97020985A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Abnormal Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 MON Company Buspar C Representative Date:11/03/97ISR Number: 3035337-4Report Type:Periodic Company Report #US97023181A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 20.00 MG Neutropenia Professional DAILY PO White Blood Cell Count Company Artane C Decreased Representative Trimethoprim C Ascorbic Acid C Ferrous Sulfate C Levothyroxine C Risperidone C 24-Jun-2005 12:19 PM Page: 105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humulin R C Date:11/03/97ISR Number: 3035339-8Report Type:Periodic Company Report #US97030610A Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Zyprexa PS ORAL 10.00 MG Decreased Professional DAILY PO White Blood Cell Count Depakote C Decreased Ativan C Date:11/03/97ISR Number: 3035342-8Report Type:Periodic Company Report #US97031204A Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS 10.00 MG Professional DAILY Company Haldol C Representative Benztropine C Depakote C Thioridazine C Date:11/03/97ISR Number: 3035344-1Report Type:Periodic Company Report #US97032989A Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS 5.00 MG Platelet Count Decreased Professional Depakote C White Blood Cell Count Decreased Date:11/03/97ISR Number: 3035345-3Report Type:Periodic Company Report #US97034036A Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 5.00 MG DAILY White Blood Cell Count Professional PO Decreased Valproic Acid C Lithium C Date:11/03/97ISR Number: 3035346-5Report Type:Periodic Company Report #US97035347A Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Prozac C Representative Depakote C Date:11/03/97ISR Number: 3035347-7Report Type:Periodic Company Report #US97035374A Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Blood Pressure Increased Health Professional 24-Jun-2005 12:19 PM Page: 106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL PO Depakote C Trazodone C Orthocept C Symmetrel C Date:11/03/97ISR Number: 3035348-9Report Type:Periodic Company Report #US97035575A Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Below Health Zyprexa PS Therapeutic Professional Carbamazepine C Date:11/03/97ISR Number: 3035350-7Report Type:Periodic Company Report #US97035989A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS 20.00 MG Neutropenia Professional DAILY Company Lorazepam C Representative Thiothixene C Trihexyphenidyl C Date:11/03/97ISR Number: 3035352-0Report Type:Periodic Company Report #US97040817A Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS ORAL 20.00 MG Phosphokinase Increased Professional DAILY PO Blood Lactate Other Dehydrogenase Increased Diarrhoea Liver Function Test Abnormal Pyrexia Date:11/03/97ISR Number: 3035354-4Report Type:Periodic Company Report #US97043247A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Autoimmune Disorder Health Zyprexa PS ORAL 15.00 MG Platelet Count Abnormal Professional DAILY PO Company Haldol C Representative Cogentin C Colace C Benadryl C Date:11/03/97ISR Number: 3035357-XReport Type:Periodic Company Report #US97044495A Age:88 YR Gender:Female I/FU:F Outcome PT Report Source White Blood Cell Count Health Decreased Professional 24-Jun-2005 12:19 PM Page: 107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 10.00 MG DAILY PO Zantac C Digoxin C Cardizem Cd C Trazodone C Ativan C Risperdal C Colace C Date:11/03/97ISR Number: 3035359-3Report Type:Periodic Company Report #US97044624A Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Muscle Spasms Company Eskalith C Representative Prozac C Trazodone C Risperdal C Date:11/03/97ISR Number: 3035361-1Report Type:Periodic Company Report #US97045263A Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperprolactinaemia Health Zyprexa PS ORAL 20.00 MG Mania Professional DAILY PO Company Valproic Acid C Representative Clonazepam C Vitamin E C Amantadine C Date:11/03/97ISR Number: 3035363-5Report Type:Periodic Company Report #US97045797A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Zyprexa PS ORAL 5.00 MG DAILY Haemoglobin Decreased Professional PO Platelet Count Decreased White Blood Cell Count Decreased Date:11/03/97ISR Number: 3035365-9Report Type:Periodic Company Report #US97046298A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Phosphokinase Increased Professional Neuroleptic Malignant Company Syndrome Representative 24-Jun-2005 12:19 PM Page: 108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035366-0Report Type:Periodic Company Report #US97046331A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa PS ORAL 10.00 MG Irritability Professional DAILY PO Libido Increased Company Anafranil C Mania Representative Dioctyl Sodium Psychomotor Hyperactivity Sulfosuccinate C Cogentin C Klonopin C Depakote C Date:11/03/97ISR Number: 3035368-4Report Type:Periodic Company Report #US97050652A Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 10.00 MG Liver Function Test Professional DAILY PO Abnormal Depakote C Date:11/03/97ISR Number: 3035369-6Report Type:Periodic Company Report #US97051819A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa PS ORAL 10.00 MG Glaucoma DAILY PO Headache Prednisone C Heart Rate Increased Nasacort C Insomnia Medication Error Nausea Sedation Tremor Vision Blurred Vomiting Date:11/03/97ISR Number: 3035371-4Report Type:Periodic Company Report #US97052455A Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 15 MG DAILY Systemic Lupus Professional PO Erythematosus Rash Depakote C Thrombocytopenia Aspirin C Date:11/03/97ISR Number: 3035373-8Report Type:Periodic Company Report #US97053790A Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS ORAL 10 MG DAILY White Blood Cell Count Professional PO Decreased Cogentin C Inderal C Loxitane C Depakote C 24-Jun-2005 12:19 PM Page: 109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035375-1Report Type:Periodic Company Report #US97055206A Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Felbatol C Lorazepam C Date:11/03/97ISR Number: 3035376-3Report Type:Periodic Company Report #US97060469A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Dilantin C Representative Valium C Doxepin C Lorazepam C Septra C Thiothixene C Phenazopyridine C Date:11/03/97ISR Number: 3035378-7Report Type:Periodic Company Report #US97060949A Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Depakote C Representative Date:11/03/97ISR Number: 3035379-9Report Type:Periodic Company Report #US97061684A Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Robinul C Neostigmine C Atropine C Diprivan C Forane C Fentanyl C Succinylcholine Chloride C Cisatracurium C Glyburide C Lithium C Synthroid C Date:11/03/97ISR Number: 3035381-7Report Type:Periodic Company Report #US97061738A Age: Gender:Female I/FU:F Outcome PT Report Source Anaemia Health Leukopenia Professional Company 24-Jun-2005 12:19 PM Page: 110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 5.00 MG DAILY PO Date:11/03/97ISR Number: 3035383-0Report Type:Periodic Company Report #US97063280A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 10 MG DAILY Potentiation Professional PO Lithium C Depakote C Mellaril C Date:11/03/97ISR Number: 3035384-2Report Type:Periodic Company Report #US97063295A Age:11 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polydipsia Health Zyprexa PS ORAL 7.5 MG DAILY Polyuria Professional PO 8 WK Lamictal C Risperdal C Date:11/03/97ISR Number: 3035385-4Report Type:Periodic Company Report #US97065122A Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 15.00 MG Alanine Aminotransferase Professional DAILY PO Increased Depakote C Aspartate Zoloft C Aminotransferase Thorazine C Increased Blood Lactate Dehydrogenase Increased Drug Interaction Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Weight Increased Date:11/03/97ISR Number: 3035386-6Report Type:Periodic Company Report #US97065602A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa PS ORAL 10 MG DAILY Sleep Disorder Professional PO Clozaril C 24-Jun-2005 12:19 PM Page: 111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035387-8Report Type:Periodic Company Report #US97070130A Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS ORAL 7.5 MG DAILY Phosphokinase Increased Professional PO 1 WK Muscle Rigidity Depakote C Pyrexia Digoxin C White Blood Cell Count Lasix C Increased Potassium C Coumadin C Date:11/03/97ISR Number: 3035388-XReport Type:Periodic Company Report #US97070151A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS 10 MG DAILY 2 DAY Syndrome Professional Date:11/03/97ISR Number: 3035389-1Report Type:Periodic Company Report #US97070163A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS 10 MG DAILY Abnormal Professional Valproate Sodium C Date:11/03/97ISR Number: 3035391-XReport Type:Periodic Company Report #US97070190A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15 MG DAILY Professional PO 2 WK Depakote C Zoloft C Date:11/03/97ISR Number: 3035392-1Report Type:Periodic Company Report #US97070202A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 5.00 MG DAILY Early Morning Awakening Professional PO 2 MON Swelling Company Effexor C Representative Date:11/03/97ISR Number: 3035393-3Report Type:Periodic Company Report #US97070319A Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Clozaril C Phenobarbital C 24-Jun-2005 12:19 PM Page: 112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035394-5Report Type:Periodic Company Report #US97070340A Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS 5.00 MG DAILY 3 WK Abnormal Professional Date:11/03/97ISR Number: 3035395-7Report Type:Periodic Company Report #US97070343A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 1 MON Professional Nardil C Premarin C Date:11/03/97ISR Number: 3035396-9Report Type:Periodic Company Report #US97070346A Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS 10.00 MG Liver Function Test Professional DAILY 2 WK Abnormal Date:11/03/97ISR Number: 3035397-0Report Type:Periodic Company Report #US97070355A Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS 7.5 MG DAILY Phosphokinase Increased Professional Influenza Liver Function Test Abnormal Date:11/03/97ISR Number: 3035398-2Report Type:Periodic Company Report #US97070466A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 7.5 MG DAILY Dry Skin Professional PO 6 MON Oedema Date:11/03/97ISR Number: 3035399-4Report Type:Periodic Company Report #US97070547A Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Lithium C Other Date:11/03/97ISR Number: 3035401-XReport Type:Periodic Company Report #US97070562A Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035402-1Report Type:Periodic Company Report #US97070568A Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Swelling Health Zyprexa PS ORAL 5.00 MG DAILY Pain Professional PO 4 MON Buspar C Date:11/03/97ISR Number: 3035404-5Report Type:Periodic Company Report #US97070583A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Other Zyprexa PS Prozac SS Date:11/03/97ISR Number: 3035406-9Report Type:Periodic Company Report #US97070604A Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa PS ORAL 5.00 MG DAILY Glaucoma Health PO Professional Glyburide C Synthroid C Coumadin C Date:11/03/97ISR Number: 3035407-0Report Type:Periodic Company Report #US97070607A Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myalgia Health Zyprexa PS ORAL 5 MG DAILY PO 1 MON Professional Coumadin C Trihexin C Lithobid C Propranolol C Date:11/03/97ISR Number: 3035409-4Report Type:Periodic Company Report #US97070613A Age:9 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 5 MG 2/DAY 2 MON Enuresis Professional Hypersomnia Medication Error Sedation Vitamin A Deficiency Date:11/03/97ISR Number: 3035412-4Report Type:Periodic Company Report #US97070619A Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatitis Health Zyprexa PS ORAL 5 MG DAILY PO 2 WK Jaundice Professional Thyroxin C Company Representative 24-Jun-2005 12:19 PM Page: 114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035414-8Report Type:Periodic Company Report #US97070622A Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 5 MG DAILY PO Professional Date:11/03/97ISR Number: 3035417-3Report Type:Periodic Company Report #US97070631A Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS ORAL 10 MG DAILY Professional PO Prozac C Date:11/03/97ISR Number: 3035419-7Report Type:Periodic Company Report #US97070658A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Professional Depakote C Company Representative Date:11/03/97ISR Number: 3035422-7Report Type:Periodic Company Report #US97070685A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 20 MG DAILY Professional PO Date:11/03/97ISR Number: 3055445-1Report Type:Periodic Company Report #US97065584A Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Agitation Professional PO Company Representative Date:11/04/97ISR Number: 3028833-7Report Type:Periodic Company Report #US97080952A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Zyprexa PS ORAL 5 MG DAILY PO Initial or Prolonged Hip Fracture Health Dilantin C Other Professional Enalapril C Digoxin C Cefazolin C Levofloxacin C Demerol C 24-Jun-2005 12:19 PM Page: 115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/97ISR Number: 3028835-0Report Type:Periodic Company Report #US97073049A Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Ecchymosis Health DAILY PO Fall Professional Risperdal C Gait Disturbance Schizophrenia C Sedation Multivitamin C Syncope Risperdal C Date:11/04/97ISR Number: 3028838-6Report Type:Periodic Company Report #US97074810A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Health DAILY PO Professional Date:11/06/97ISR Number: 3005698-0Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Olanzapine PS 15MG QHS Valproic Acid SS 1500 MG BID Lorazepam C Tetanus Toxiod C Benztropine C Date:11/10/97ISR Number: 100000202Report Type:Expedited (15-DaCompany Report #US97105689A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Health Zyprexa PS Professional Droperidol C Date:11/10/97ISR Number: 100000202Report Type:Expedited (15-DaCompany Report #US97106025A Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS ORAL 5MG DAILY PO Professional Ciprofloxacin C ORAL 500MG 2/DAY PO Haldol C 1MG PO Date:11/10/97ISR Number: 100000202Report Type:Expedited (15-DaCompany Report #US97106061A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Health Zyprexa PS 10MG DAILY Hospitalization - Professional Carbidopa C ORAL 25MG 2/DAY PO Initial or Prolonged Levodopa C ORAL 250MG 2/D PO 24-Jun-2005 12:19 PM Page: 116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #GB97105638A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 20.00 MG Initial or Prolonged Phosphokinase Increased Health Procyclidine Depressed Level Of Professional Hydrochloride C 10.00 MG; Consciousness 2/DAY Drug Interaction Chlormethiazole C 2.00 TABLETS Neuroleptic Malignant Clozapine C 12.50 MG Syndrome Pyrexia Tachycardia Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #GB97103901A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Tardive Dyskinesia Health DAILY PO Professional Trifluoperazine C ORAL 5.00 MG Other 2/DAY PO Procyclidine C ORAL 5.00 MG UNK/D PO Haloperidol Decanoate C Aspirin C ORAL 150 MG UNK/D PO Atenolol C ORAL 25.00 MG 1/D PO Zopiclone C ORAL 7.50 MG UNK/D PO Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #DK97105716A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 15.00 MG Initial or Prolonged Neutropenia Health Cisordinol C 6.00 MG Professional UNKNOWN Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #ES97105755A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Health Risperdal C Professional Idalprem C Benzodiazepine C Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #BR97105686A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colour Vision Tests Foreign Zyprexa PS ORAL 30.00 MG Abnormal 3/DAY PO 45 DAY Lethargy Chlorpromazine C 24-Jun-2005 12:19 PM Page: 117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/97ISR Number: 100000227Report Type:Expedited (15-DaCompany Report #AU97105278A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS UNK Sudden Death Other Verapamil C Date:11/10/97ISR Number: 3000107-XReport Type:Expedited (15-DaCompany Report #CA97062959A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Flushing Health DAILY Pain In Extremity Professional Vasodilatation Date:11/10/97ISR Number: 3000116-0Report Type:Expedited (15-DaCompany Report #USA97100640 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Zyprexa PS ORAL 10.00 MG Hospitalization - Professional DAILY PO Initial or Prolonged Company Moban C Representative Klonopin C Date:11/10/97ISR Number: 3000126-3Report Type:Expedited (15-DaCompany Report #F197051042A Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa PS ORAL 5.00 MG DAILY Life-Threatening Lung Neoplasm Malignant Health PO Hospitalization - Muscle Rigidity Professional Suprium C Initial or Prolonged Neuroleptic Malignant Effortil C Syndrome Aktipar C Parkinsonism Eldepryl C Pneumonia Pyrexia Date:11/10/97ISR Number: 3000129-9Report Type:Expedited (15-DaCompany Report #ES97103274A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS ORAL 10.00 MG Hospitalization - Phosphokinase Increased Health DAILYPO Initial or Prolonged Confusional State Professional Imipramine C Depressed Level Of Sertraline C Consciousness Disseminated Intravascular Coagulation Hyperhidrosis Hypertension Hypotension Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/97ISR Number: 3005747-XReport Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Olanzapine PS 10 MG QD 2 WK Initial or Prolonged Dysphagia Atenolol C Weight Decreased Colace C Lovastatin C Buspar C Date:11/17/97ISR Number: 3000744-2Report Type:Expedited (15-DaCompany Report #US97110952A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Erythematous Health Zyprexa PS ORAL 5.00 MG DAILY Rash Generalised Professional PO Luvox C Cogentin C 1.00 MG 2/D Buspar C 10.00 MG 3/D Paxil C 20.00 MG 1/D Date:11/17/97ISR Number: 3000746-6Report Type:Expedited (15-DaCompany Report #US97106787A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Zyprexa PS ORAL 5.00 MG 2/DAY Initial or Prolonged Medication Error Professional PO Platelet Count Decreased Bactrim Ds C Thrombocytopenia Risperdal C Date:11/17/97ISR Number: 3000748-XReport Type:Expedited (15-DaCompany Report #US97106181A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blindness Health DAILY PO Other Confusional State Professional Depakote C Deafness Diabetes Mellitus Hepatitis Hyperglycaemia Hypothyroidism Insomnia Memory Impairment Nephritis Pancreatic Insufficiency Pollakiuria Thirst Weight Decreased Date:11/17/97ISR Number: 3000749-1Report Type:Expedited (15-DaCompany Report #CA97106220A Age:24 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa PS ORAL 40.00 MG Initial or Prolonged Sedation Health /UNK/PO Other Professional 24-Jun-2005 12:19 PM Page: 119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/97ISR Number: 3000750-8Report Type:Expedited (15-DaCompany Report #US97111288A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS UNK Initial or Prolonged Phosphokinase Increased Professional Wellbutrin C Body Temperature Company Lithium C Increased Representative Depakote C Hypertonia Cytomel C Neuroleptic Malignant Trilafon C Syndrome Date:11/17/97ISR Number: 3000989-1Report Type:Expedited (15-DaCompany Report #DE97104828A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS ORAL 30.00 MG Health DAILY PO Professional Melleril C 75.00 MG DAILY Date:11/17/97ISR Number: 3000990-8Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS UNK Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Convulsion Date:11/17/97ISR Number: 3001236-7Report Type:Expedited (15-DaCompany Report #US97100640A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening White Blood Cell Count Health Zyprexa PS ORAL 10.00 MG Hospitalization - Decreased Professional DAILY PO Initial or Prolonged Company Moban C Representative Date:11/17/97ISR Number: 3001237-9Report Type:Expedited (15-DaCompany Report #GB97103619A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 20.00 MG Stress Health DAILY PO Professional Fluoxetine C ORAL 40.00 MG Company DAILY PO Representative Date:11/17/97ISR Number: 3001239-2Report Type:Expedited (15-DaCompany Report #GB97103901A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Tardive Dyskinesia Health DAILY PO Professional Trifluoperazine C Other Procyclidine C 24-Jun-2005 12:19 PM Page: 120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haloperidol C Aspirin C Atenolol C Zopiclone C Date:11/17/97ISR Number: 3001243-4Report Type:Expedited (15-DaCompany Report #DE97084396A Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Zyprexa PS ORAL 40.00 MG Coma Health DAILY PO Professional Isoket Retard C 20.00 MG DAILY UNK Euglucon C Glucobay C ORAL 400.00 MG UNK/D PO Date:11/17/97ISR Number: 3005717-1Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Zyprexa PS ORAL PO 5MG BID + Intervention to Dysphagia 10 MG HS Prevent Permanent Face Oedema Lithium C Impairment/Damage Glossitis Valproic Acid C Klonopin C Navane C Date:11/17/97ISR Number: 3005794-8Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Zyprexa PS ORAL 10MG EVERYDAY 1 MON Neurontin C Premarin C Klonopin C Date:11/17/97ISR Number: 3006050-4Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Olanzapine PS ORAL PO Lamotrigine C Date:11/17/97ISR Number: 3031425-7Report Type:Expedited (15-DaCompany Report #US98021327A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Zyprexa PS Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/97ISR Number: 3005965-0Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Olanzapine PS Lilly ORAL 5 MG PO Initial or Prolonged Sedation Ritalin C Luvox C Oxybutinin C Carbamazepine C Respiradone C Ddavp C Date:11/20/97ISR Number: 3006036-XReport Type:Direct Company Report # Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clonazepam PS Initial or Prolonged Depressed Level Of Professional Amlodipine SS Consciousness Olanzapine SS Lethargy Overdose Respiratory Failure Date:11/21/97ISR Number: 3006527-1Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aphasia Zyprexa PS ORAL 5MG PO DAILY Required Depressed Level Of Serzone C Intervention to Consciousness Cylert C Prevent Permanent Drug Withdrawal Syndrome Synthroid C Impairment/Damage Nausea Obsessive-Compulsive Disorder Water Intoxication Date:11/21/97ISR Number: 3007243-2Report Type:Expedited (15-DaCompany Report #US96121279A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL Initial or Prolonged Phosphokinase Increased Professional Clonazepam C Blood Sodium Increased Diazepam C Neuroleptic Malignant Cephalosporin C C Syndrome Cipro C Ativa C Date:11/21/97ISR Number: 3007244-4Report Type:Expedited (15-DaCompany Report #GB97105968A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Foreign Zyprexa PS ORAL Initial or Prolonged Face Oedema Health Unknown C Hypersensitivity Professional 24-Jun-2005 12:19 PM Page: 122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/97ISR Number: 3007245-6Report Type:Expedited (15-DaCompany Report #GB97105638A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS ORAL Initial or Prolonged Phosphokinase Increased Health Procyclidine Body Temperature Professional Hydrochloride C ORAL Increased Chlormethiazole C ORAL Depressed Level Of Clozapine C ORAL Consciousness Drug Interaction Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Tachycardia Vomiting Date:11/21/97ISR Number: 3007246-8Report Type:Expedited (15-DaCompany Report #US97061054A Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Zyprexa PS 5.OO MG DAILY Initial or Prolonged Confusional State Professional UNK 9 DAY Grand Mal Convulsion Company Prozac C Hyponatraemia Representative Effexor C Date:11/21/97ISR Number: 3007247-XReport Type:Expedited (15-DaCompany Report #US97044960A Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Zyprexa PS ORAL 10 MG/DAY PO Dermatitis Professional Depakote C Glomerulonephritis Company Klonopin C ORAL Proliferative Representative Trilafon C Hypersensitivity Hypertension Nephrotic Syndrome Oedema Peripheral Renal Failure Swelling Weight Increased Date:11/21/97ISR Number: 3007248-1Report Type:Expedited (15-DaCompany Report #US97104963A Age:6 WK Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS 28 WK Cardiac Murmur Professional Complications Of Maternal Exposure To Therapeutic Drugs Sudden Infant Death Syndrome 24-Jun-2005 12:19 PM Page: 123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/97ISR Number: 3007249-3Report Type:Expedited (15-DaCompany Report #US97110952A Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Multiforme Health Zyprexa PS ORAL 5.00 MG Professional DAILY PO Luvox C Cogentin C Buspar C Paxil C Date:11/21/97ISR Number: 3007435-2Report Type:Expedited (15-DaCompany Report #CA97053163A Age:17 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lethargy Foreign Zyprexa PS ORAL 100 MG (10 Hospitalization - Overdose Health 10MG TABS) - Initial or Prolonged Professional OVERDOSE 1 DAY Other Other Date:11/25/97ISR Number: 3002351-4Report Type:Expedited (15-DaCompany Report #US97112359A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Health Zyprexa PS ORAL 3 WK Initial or Prolonged Leukopenia Professional Unknown C Platelet Count Abnormal Platelet Count Decreased Pyrexia Splenomegaly Date:11/25/97ISR Number: 3002352-6Report Type:Expedited (15-DaCompany Report #US97111609A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS ORAL 1 WK Initial or Prolonged Grand Mal Convulsion Professional Haldol C Tegretol C Depakote C Date:11/25/97ISR Number: 3002353-8Report Type:Expedited (15-DaCompany Report #US97111315A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Professional Company Representative Date:11/25/97ISR Number: 3002986-9Report Type:Expedited (15-DaCompany Report #US97035614A Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Hyponatraemia Professional 2/DAY PO Water Intoxication Company Representative 24-Jun-2005 12:19 PM Page: 124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/97ISR Number: 3003477-1Report Type:Expedited (15-DaCompany Report #SI97112794A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blood Creatine Professional DAILY PO Phosphokinase Increased Diazepam C Catatonia Fluphenazine C Haloperidol C Levomepromazine C Biperiden C Date:11/25/97ISR Number: 3003478-3Report Type:Expedited (15-DaCompany Report #CA97112086A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Zyprexa PS ORAL 5.00MG DAILY Platelet Count Decreased Health PO Pyrexia Professional Valproic Acid C White Blood Cell Count Cogentin C Decreased Tazocin C Date:11/25/97ISR Number: 3003480-1Report Type:Expedited (15-DaCompany Report #US97112521A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zyprexa PS UNK 2 MON Obesity Professional Company Representative Date:11/25/97ISR Number: 3003549-1Report Type:Expedited (15-DaCompany Report #US97111321A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS ORAL 20.00 MG PO 5 MON Depression Professional Drug Ineffective Company Therapeutic Response Representative Unexpected Date:11/25/97ISR Number: 3003551-XReport Type:Expedited (15-DaCompany Report #US97112182A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa PS Initial or Prolonged Increased Professional Sertraline C Blood Urea Increased Company Coma Representative Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/97ISR Number: 3002980-8Report Type:Expedited (15-DaCompany Report #IT97103688A Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Foreign Zyprexa PS ORAL 10.00MG DAILY Initial or Prolonged Pneumonia Health PO Pyrexia Professional Depakine C Stupor Tavor C Microren C Na C Date:11/26/97ISR Number: 3002983-3Report Type:Expedited (15-DaCompany Report #CA97106220A Age:24 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa PS 40.00MG PO Initial or Prolonged Sedation Health Other Professional Date:11/26/97ISR Number: 3002984-5Report Type:Expedited (15-DaCompany Report #CA97053163A Age:17 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Above Foreign Zyprexa PS ORAL 100.00 MG 1/ Hospitalization - Therapeutic Health PO 1 DAY Initial or Prolonged Lethargy Professional Other Overdose Date:11/26/97ISR Number: 3002989-4Report Type:Expedited (15-DaCompany Report #US97073019A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Lithium C Representative Cogentin C Date:11/26/97ISR Number: 3002991-2Report Type:Expedited (15-DaCompany Report #US97112182A Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa PS UNKNOWN UNK Initial or Prolonged Increased Professional Sertraline C Aspartate Company Aminotransferase Representative Increased Blood Creatinine Increased Blood Urea Increased Coma Depressed Level Of Consciousness Liver Function Test Abnormal Renal Impairment 24-Jun-2005 12:19 PM Page: 126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/97ISR Number: 3006037-1Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Olanzapine PS C 4 #1 1 MON Date:12/01/97ISR Number: 3051266-4Report Type:Periodic Company Report #9718419 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Cardura PS ORAL 6.00 MG Professional TOTAL, DAILY, ORAL Olanzapine SS Lithium C Benzodiazepines C Date:12/02/97ISR Number: 3003848-3Report Type:Expedited (15-DaCompany Report #GB97110034A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 15 MG Initial or Prolonged Phosphokinase Increased Health Chlorpromazine C Hyperhidrosis Professional Procyclidine C Hypertension Company Clomipramine C Neuroleptic Malignant Representative Syndrome Pallor Personality Disorder Date:12/02/97ISR Number: 3003859-8Report Type:Expedited (15-DaCompany Report #US97062929A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Zyprexa PS ORAL 800.00 MG UNK Increased Professional PO Coordination Abnormal Disorientation Dysarthria Dystonia Intentional Misuse Pain Pyrexia Sedation Tachycardia Date:12/02/97ISR Number: 3003860-4Report Type:Expedited (15-DaCompany Report #US97105440A Age:17 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Depressed Level Of Other Consciousness Hostility Miosis Nervousness Overdose Restlessness 24-Jun-2005 12:19 PM Page: 127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 500.00 MG 1/ Professional PO Ventolin C Depakote C Date:12/02/97ISR Number: 3003861-6Report Type:Expedited (15-DaCompany Report #US97114162A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Consumer Zyprexa PS ORAL 5.00 MG Initial or Prolonged Thromboplastin Time DAILY PO Prolonged Doxepin C Levothyroxine C Cogentin C Date:12/02/97ISR Number: 3003862-8Report Type:Expedited (15-DaCompany Report #US97113883A Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS 75.00 MG UNK Initial or Prolonged Professional UNK Lithium C Date:12/03/97ISR Number: 3004080-XReport Type:Expedited (15-DaCompany Report #DK97113259A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Foreign Zyprexa PS ORAL 10.00 MG PO Health Oxazepam C Professional Clonazepam C Truxal C Orphenadrine C Date:12/03/97ISR Number: 3006684-7Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Olanzapine PS Lilly ORAL 20 MG Q HS PO Required Li2 Co3 C Intervention to Fluoxetine C Prevent Permanent Impairment/Damage Date:12/03/97ISR Number: 3007317-6Report Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Zyprexa PS 5 MG 1QD Initial or Prolonged Dysphagia Zyprena SS 10MG 1QD Pyrexia Tongue Spasm 24-Jun-2005 12:19 PM Page: 128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/97ISR Number: 3002968-7Report Type:Expedited (15-DaCompany Report #DE97093301A Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa PS ORAL 20.00 MG Hospitalization - Circulatory Collapse Health DAILY PO Initial or Prolonged Professional Diazepam C Haloperidol C Date:12/04/97ISR Number: 3002970-5Report Type:Expedited (15-DaCompany Report #DK97105716A Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 15.00 MG Initial or Prolonged Neutropenia Health Cisordinol C Professional Rivotril C Date:12/04/97ISR Number: 3002978-XReport Type:Expedited (15-DaCompany Report #FI97051042A Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS ORAL 5.00 MG DAILY Life-Threatening Phosphokinase Increased Health PO Hospitalization - Extrapyramidal Disorder Professional Suprium C Initial or Prolonged Hypertonia Effortil C Disability Lung Neoplasm Malignant Aktipar C Muscle Rigidity Eldepryl C Neuroleptic Malignant Syndrome Parkinsonism Pneumonia Pyrexia Date:12/04/97ISR Number: 3002979-1Report Type:Expedited (15-DaCompany Report #GB97105968A Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Shock Foreign Zyprexa PS ORAL 20.00 MG PO Initial or Prolonged Catatonia Health Dermatitis Bullous Professional Face Oedema Hypersensitivity Date:12/04/97ISR Number: 3002981-XReport Type:Expedited (15-DaCompany Report #CA97112086A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Foreign Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Folate Deficiency Health PO Other Haemoglobin Decreased Professional Valproic Acid C Leukopenia Cogentin C Neutrophil Count Tazocin C Decreased Pancytopenia Pyrexia Reticulocyte Count Increased Thrombocytopenia 24-Jun-2005 12:19 PM Page: 129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/97ISR Number: 3007563-1Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Olanzapine PS Lilly ORAL 5MG BID PO 8 MON Benztropine C Divalproex C Date:12/04/97ISR Number: 3007592-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Zyprexa PS Eli-Lilly 5 MG HS Tenex C Date:12/08/97ISR Number: 3004381-5Report Type:Expedited (15-DaCompany Report #ES97105755A Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Oedema Foreign Zyprexa PS ORAL UNK UNK Respiratory Failure Health PO Professional Risperdal C Idalprem C Benzodiazepine C Date:12/08/97ISR Number: 3004385-2Report Type:Expedited (15-DaCompany Report #US97112521A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zyprexa PS 20.00 MG Professional DAILY 2 MON Company Representative Date:12/08/97ISR Number: 3004390-6Report Type:Expedited (15-DaCompany Report #US97111609A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Professional PO 1 WK Company Haldol C Representative Tegretol C Depakote C Date:12/08/97ISR Number: 3004392-XReport Type:Expedited (15-DaCompany Report #US97114162A Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Thromboplastin Time PO Prolonged Doxepin C Asthenia Levothyroxine C Dizziness Cogentin C Extrapyramidal Disorder Hyponatraemia 24-Jun-2005 12:19 PM Page: 130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/97ISR Number: 3004393-1Report Type:Expedited (15-DaCompany Report #US97106181A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blindness Health DAILY PO Confusional State Professional Depakote C Deafness Diabetes Mellitus Fatigue Hepatomegaly Hydronephrosis Hypothyroidism Insomnia Leukocytosis Memory Impairment Pancreatic Disorder Pollakiuria Proteinuria Renal Disorder Skin Papilloma Thirst Vision Blurred Visual Acuity Reduced Weight Decreased Date:12/08/97ISR Number: 3004394-3Report Type:Expedited (15-DaCompany Report #US97105197A Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lower Respiratory Tract Health Zyprexa PS 20.00 MG Infection Professional DAILY Pulmonary Fibrosis Haloperidol C Benadryl C Zoloft C Cogentin C Klonopin C Pravachol C Tenormin C Nitroglycerin C Buspar C Date:12/08/97ISR Number: 3004771-0Report Type:Expedited (15-DaCompany Report #GB97113169A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Prozac SS ORAL 60 MG DAILY Other PO Date:12/08/97ISR Number: 3004857-0Report Type:Expedited (15-DaCompany Report #IE97113664A Age: Gender:Female I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS UNK Date:12/08/97ISR Number: 3004889-2Report Type:Expedited (15-DaCompany Report #DE97113979A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 5.00 MG UNK Health PO Professional Haloperidol C Trihexyphenidyl C Date:12/08/97ISR Number: 3004890-9Report Type:Expedited (15-DaCompany Report #GB97113169A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Prozac SS ORAL 60 MG DAILY PO Date:12/08/97ISR Number: 3004894-6Report Type:Expedited (15-DaCompany Report #US97114654A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS ORAL 20 MG DAILY Professional PO Dilantin C Date:12/08/97ISR Number: 3004899-5Report Type:Expedited (15-DaCompany Report #US97114645A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS ORAL 20 MG DAILY Professional PO Date:12/08/97ISR Number: 3004905-8Report Type:Expedited (15-DaCompany Report #US97114621A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Muscle Rigidity Health Zyprexa PS UNK Hospitalization - Neuroleptic Malignant Professional Prolixin C Initial or Prolonged Syndrome Ativan C Psychotic Disorder Cogentin C Pyrexia Tachycardia Date:12/08/97ISR Number: 3004907-1Report Type:Expedited (15-DaCompany Report #AU97114249A Age: Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Overdose Foreign Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 240 MG DAILY PO Date:12/08/97ISR Number: 3018274-0Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Zyprexa PS Lilly ORAL 600 MG X 1 PO Initial or Prolonged Confusional State Liver Function Test Abnormal Overdose Sedation Date:12/11/97ISR Number: 3007329-2Report Type:Expedited (15-DaCompany Report #A001-002-001737 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Aricept PS Eisai, Inc. ORAL NA, PER ORAL Other Professional Zyprexa SS Date:12/11/97ISR Number: 3007339-5Report Type:Expedited (15-DaCompany Report #970902-SK889 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Calan PS ORAL 560.000 MG QD Other Professional PO 2 YR Olanzapine SS ORAL 5.000 MG BID PO 36 MON Date:12/11/97ISR Number: 3007635-1Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Olanzapine PS ORAL 2.5 MG QHD 1 WK Obsessive-Compulsive Fluvoxamine C Disorder Date:12/11/97ISR Number: 3007636-3Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Olanzapine PS Lilly ORAL 20 MG QHS PO Required Lithium Carbonate C Intervention to Fluoxetine C Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/97ISR Number: 3006836-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Olanzapine PS 10 MG BID QID Abnormal Valproic Acid SS 250 MG QID Phenytoin C Streptomycin C Haldol C Ampicillin C Diazepam C Ferrous Sulfate C Date:12/15/97ISR Number: 3008701-7Report Type:Expedited (15-DaCompany Report #GB97115389A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa PS 7.50MG DAILY Health UNK Professional Date:12/15/97ISR Number: 3008709-1Report Type:Expedited (15-DaCompany Report #GB97115263A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Initial or Prolonged Phosphokinase Increased Health Company 15.00 MG Body Temperature Professional Increased Convulsion Lower Respiratory Tract Infection Malaise Nervous System Disorder Neuroleptic Malignant Syndrome Pneumonia Date:12/15/97ISR Number: 3008714-5Report Type:Expedited (15-DaCompany Report #US97074021A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Consumer Zyprexa PS ORAL 10 MG DAILY Health Oxycodone C Professional Acetaminophen C Date:12/15/97ISR Number: 3008720-0Report Type:Expedited (15-DaCompany Report #DE97120985A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS ORAL 15.00 MG; Initial or Prolonged Colitis Health UNK/ PO Diarrhoea Professional Haloperidol C Faeces Discoloured Promethazine C Haemorrhage Diazepam C 24-Jun-2005 12:19 PM Page: 134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/97ISR Number: 3008722-4Report Type:Expedited (15-DaCompany Report #DE97115272A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zyprexa PS ORAL 100.00 MG PO Initial or Prolonged Intentional Misuse Health Other Suicide Attempt Professional Date:12/15/97ISR Number: 3008725-XReport Type:Expedited (15-DaCompany Report #ES97072485A Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Encephalopathy Foreign Zyprexa PS ORAL 10.00 MG Hospitalization - Mental Disorder Due To A Health DAILY PO Initial or Prolonged General Medical Condition Professional Platelet Count Decreased Company Portal Hypertension Representative Sedation White Blood Cell Count Decreased Date:12/15/97ISR Number: 3008726-1Report Type:Expedited (15-DaCompany Report #AU97120622A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Foreign Zyprexa PS ORAL 35.00 MG Initial or Prolonged Thrombocytopenia Health DAILY PO Professional Haloperidol C Date:12/15/97ISR Number: 3008728-5Report Type:Expedited (15-DaCompany Report #US97120754A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Health Zyprexa PS UNK Increased Professional Date:12/15/97ISR Number: 3008730-3Report Type:Expedited (15-DaCompany Report #US97120859A Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Other Zyprexa PS UNK. Initial or Prolonged Tylenol C Date:12/15/97ISR Number: 3008733-9Report Type:Expedited (15-DaCompany Report #US97120433A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Literature Zyprexa PS ORAL 200.00 MG UNK Initial or Prolonged Sinus Tachycardia PO Other 24-Jun-2005 12:19 PM Page: 135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/97ISR Number: 3008737-6Report Type:Expedited (15-DaCompany Report #US97120520A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Literature Zyprexa PS Initial or Prolonged Coma Health Amitriptyline C Other Therapeutic Agent Professional Lorazepam C Toxicity Depakote C Date:12/16/97ISR Number: 3008281-6Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Olanzapine PS ORAL 20 MG QHS PO (5MG ON 10/25/96 TITRATED UP TO 20 MG BY Buspar C Librium C Date:12/16/97ISR Number: 3008291-9Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activated Partial Olanzapine PS 20/MG/D Thromboplastin Time Shortened Date:12/16/97ISR Number: 3008292-0Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Olanzapine PS Eli Lilly 20MG /D Dilantin C Date:12/17/97ISR Number: 3011603-3Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Agitation Blood Creatine Phosphokinase Increased Body Temperature Increased Cognitive Disorder Confusional State Delirium Dementia Hallucination Insomnia Movement Disorder Neuroleptic Malignant Syndrome Paranoia Prostatitis Pyrexia Tearfulness 24-Jun-2005 12:19 PM Page: 136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Urinary Retention Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS ORAL 1.25MG, QHS, PO Date:12/17/97ISR Number: 3019064-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Zyprexa PS 20 MG/DAY Drug Interaction Klonopin SS 1 MG/DAY Date:12/18/97ISR Number: 3009290-3Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Zyprexa PS ORAL 15 MG PO OD 9 MON Tardive Dyskinesia Date:12/18/97ISR Number: 3009323-4Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Zyprexa PS 10 MG IN AM AND 20 MG Date:12/19/97ISR Number: 3009130-2Report Type:Expedited (15-DaCompany Report #GB97114861A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Foreign Zyprexa PS ORAL 15.00 MG Skin Irritation Health DAILY PO Professional Omeprazole C Other Date:12/19/97ISR Number: 3009618-4Report Type:Expedited (15-DaCompany Report #AU97122107A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrasystoles Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Health DAILY PO Professional Date:12/19/97ISR Number: 3009622-6Report Type:Expedited (15-DaCompany Report #US97121726A Age:46 YR Gender:Female I/FU:I Outcome PT Death Apnoea Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Coma Other Dizziness Hepatic Failure Hyperglycaemia 24-Jun-2005 12:19 PM Page: 137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Lactic Acidosis Nausea Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 20.00 MG Syndrome Professional DAILY PO Pyrexia Haldol C Renal Failure Benadryl C Respiratory Failure Restoril C Vomiting Anaprox C Soma C Date:12/19/97ISR Number: 3009623-8Report Type:Expedited (15-DaCompany Report #US97121720A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa PS Death Professional Date:12/19/97ISR Number: 3009627-5Report Type:Expedited (15-DaCompany Report #DE97121240A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa PS ORAL 10.00 MG PO Initial or Prolonged Hypersensitivity Health Professional Other Date:12/19/97ISR Number: 3009629-9Report Type:Expedited (15-DaCompany Report #DE97121807A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zyprexa PS ORAL 7.50 MG DAILY Initial or Prolonged Dystonia Health PO Tremor Professional Haloperidol C Lithium C Date:12/19/97ISR Number: 3009633-0Report Type:Expedited (15-DaCompany Report #US97121696A Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Zyprexa PS 5.0 MG DAILY Hospitalization - Blood Pressure Decreased Professional Risperdal C Initial or Prolonged Cerebrovascular Accident Company Thyroid C Heart Rate Decreased Representative Hyperhidrosis Respiratory Failure Stupor Tongue Paralysis Date:12/19/97ISR Number: 3009637-8Report Type:Expedited (15-DaCompany Report #US97121948A Age: Gender:Male I/FU:I Outcome PT Hospitalization - Hyperglycaemia Initial or Prolonged Intentional Misuse Other Malaise 24-Jun-2005 12:19 PM Page: 138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 30.00 MG PO Professional Date:12/19/97ISR Number: 3009640-8Report Type:Expedited (15-DaCompany Report #US97122968A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Date:12/19/97ISR Number: 3009642-1Report Type:Expedited (15-DaCompany Report #US97122557A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Zyprexa PS ORAL 15 MG DAILY Nausea Professional PO Pulmonary Embolism Uniphyl C Vomiting Atrovent C Flovent C Intal C Ventolin C Depakote C Aldactone C Cytomel C Provera C Climara C Xanax C Date:12/19/97ISR Number: 3009645-7Report Type:Expedited (15-DaCompany Report #NZ97104234A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Foreign Zyprexa PS ORAL 20.0 MG DAILY Alanine Aminotransferase Health PO Increased Professional Valproate Sodium C Aspartate Company Aminotransferase Representative Increased Drug Ineffective Leukopenia Neutropenia Date:12/19/97ISR Number: 3009650-0Report Type:Expedited (15-DaCompany Report #NO97121936A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa PS 20 MG Initial or Prolonged Loss Of Consciousness Health Other Overdose Professional 24-Jun-2005 12:19 PM Page: 139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/97ISR Number: 3009651-2Report Type:Expedited (15-DaCompany Report #GB97122461A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS Initial or Prolonged Circulatory Collapse Health Electrocardiogram Professional Abnormal Date:12/19/97ISR Number: 3009656-1Report Type:Expedited (15-DaCompany Report #GB97114885A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa PS ORAL 20 MG DAILY Dermatitis Health PO Professional Fluoxetine C Other Diazepam C Chlorpheniramine C Thioridazine C Date:12/19/97ISR Number: 3009737-2Report Type:Expedited (15-DaCompany Report #ES97120940A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 20.00MG DAILY Health PO 1 MON Professional Company Representative Date:12/19/97ISR Number: 3009741-4Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS Initial or Prolonged Health Professional Date:12/19/97ISR Number: 3009745-1Report Type:Expedited (15-DaCompany Report #GB97115389A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS 7.50 MG DAILY Sedation Health Haloperidol C Professional Marvelon C Date:12/19/97ISR Number: 3009747-5Report Type:Expedited (15-DaCompany Report #GB97076061A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Limb Crushing Injury Foreign Zyprexa PS Pulmonary Embolism Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/97ISR Number: 3009750-5Report Type:Expedited (15-DaCompany Report #US97120721A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Zyprexa PS ORAL 5.00MG DAILY Initial or Prolonged Heart Rate Decreased Professional PO Sedation Other Ritalin C 20 MG BID Luvox C 150 MG Oxybutynin C 5 MG TID Carbamazepine C 500 MG BID Risperidone C 1 MG Ddavp C Date:12/19/97ISR Number: 3009753-0Report Type:Expedited (15-DaCompany Report #AU97120622A Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antibody Test Positive Foreign Zyprexa PS ORAL 35.00 MG Initial or Prolonged Lymphopenia Health DAILY PO Other Thrombocytopenia Professional Haloperidol C Date:12/19/97ISR Number: 3009759-1Report Type:Expedited (15-DaCompany Report #CA97053163A Age:17 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lethargy Foreign Zyprexa PS 100.00 MG 1/ Hospitalization - Overdose Health PO 1 DAY Initial or Prolonged Professional Other Date:12/19/97ISR Number: 3011666-5Report Type:Expedited (15-DaCompany Report #US97121714A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Aspartate Professional DAILY Aminotransferase Company Effexor C Increased Representative Blood Creatine Phosphokinase Increased Coma Delirium Difficulty In Walking Miosis Muscle Rigidity Neuroleptic Malignant Syndrome Neuropathy Peripheral Pyrexia Renal Failure Renal Failure Acute Renal Impairment Rhabdomyolysis Sinus Tachycardia Speech Disorder Stupor Tachycardia 24-Jun-2005 12:19 PM Page: 141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/97ISR Number: 3011672-0Report Type:Expedited (15-DaCompany Report #US97121702A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Zyprexa PS ORAL 12.50 MG UNK Sudden Death Professional PO Company Haldol C Representative Zoloft C Date:12/19/97ISR Number: 3011861-5Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Zyprexa PS Eli Lilly Initial or Prolonged Aricept SS Ei Sai ORAL 10 MG PO QDAY Date:12/19/97ISR Number: 3011869-XReport Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Fluvoxamine PS Sedation Olanzapine SS Date:12/29/97ISR Number: 3013083-0Report Type:Expedited (15-DaCompany Report #US97121702A Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Zyprexa PS ORAL 12.50 MG PO 5 MON Asphyxia Professional Haldol C Company Zoloft C Representative Date:12/29/97ISR Number: 3013086-6Report Type:Expedited (15-DaCompany Report #US97121720A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Zyprexa PS ORAL 25.00 MG Other Professional DAILY PO Glucotrol C Glucophage C Inderal C Procardia C Vasotec C Albuterol C Date:12/29/97ISR Number: 3013476-1Report Type:Expedited (15-DaCompany Report #US97014375A Age:25 YR Gender:Female I/FU:F Outcome PT Hospitalization - Coma Initial or Prolonged Condition Aggravated Other Convulsion Required Depressed Level Of Intervention to Consciousness Prevent Permanent Drooling Impairment/Damage Dystonia Encephalitis Viral 24-Jun-2005 12:19 PM Page: 142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Joint Stiffness Leukocytosis Meningitis Viral Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 5.00 MG DAILY Muscle Rigidity Professional PO Neuroleptic Malignant Lithium C Syndrome Paranoia Respiratory Failure Stupor Temperature Regulation Disorder Date:12/29/97ISR Number: 3013479-7Report Type:Expedited (15-DaCompany Report #US97022203A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Encephalitis Viral Professional PO 2 DAY Other Loss Of Consciousness Lithium C Mental Impairment Cogentin C Neuroleptic Malignant Perphenazine C Syndrome Respiratory Failure Stupor Date:12/29/97ISR Number: 3013514-6Report Type:Expedited (15-DaCompany Report #US97121948A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS ORAL 30.00 MG PO Initial or Prolonged Vomiting Professional Other Date:12/29/97ISR Number: 3014991-7Report Type:Expedited (15-DaCompany Report #DE97115272A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zyprexa PS ORAL 100.00 MG UNK Initial or Prolonged Suicide Attempt Health PO Other Professional Date:12/29/97ISR Number: 3014992-9Report Type:Expedited (15-DaCompany Report #DE97120985A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS ORAL 15.00 MG UNK Initial or Prolonged Crohn'S Disease Health PO Diarrhoea Professional Haloperidol C Enterocolitis Promethazine C Haemorrhagic Diazepam C Faeces Discoloured Melaena 24-Jun-2005 12:19 PM Page: 143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/97ISR Number: 3015827-0Report Type:Expedited (15-DaCompany Report #AU97122113A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoproteinaemia Foreign Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Nephrotic Syndrome Health PO Oedema Peripheral Professional Lithium C Proteinuria Metformin C Frusemide C Potassium Chloride C Amoxycillin C Date:12/29/97ISR Number: 3015829-4Report Type:Expedited (15-DaCompany Report #AU97123034A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Zyprexa PS 5 MG DAILY Initial or Prolonged Psychotic Disorder Health Sedation Professional Date:12/29/97ISR Number: 3015831-2Report Type:Expedited (15-DaCompany Report #AU97123355A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa PS ORAL 200 MG DAILY Initial or Prolonged Tachycardia Health PO Other Professional Diazepam C Sertraline C Date:12/29/97ISR Number: 3015833-6Report Type:Expedited (15-DaCompany Report #CA97122977A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 10.00 MG Initial or Prolonged Phosphokinase Increased Health DAILY PO Other Blood Pressure Professional Epival C Fluctuation Chorea Cognitive Disorder Delirium Drooling Dysphagia Extrapyramidal Disorder Hallucination, Visual Hyperhidrosis Muscle Rigidity Mutism Parkinsonian Gait Posturing Urinary Incontinence Date:12/29/97ISR Number: 3015848-8Report Type:Expedited (15-DaCompany Report #US97121564A Age:50 YR Gender:Male I/FU:I Outcome PT Hospitalization - Hyperglycaemia Initial or Prolonged Intentional Misuse Other Malaise 24-Jun-2005 12:19 PM Page: 144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Vomiting Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 30.00 MG Professional DAILY PO 5 MON Date:12/29/97ISR Number: 3015849-XReport Type:Expedited (15-DaCompany Report #US97082299A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 1200.00 MG Initial or Prolonged Dyspnoea Professional 1/ PO 1 DAY Other Electrocardiogram Qt Vancomycin C Prolonged Serax C Heart Rate Increased Gentamicin C Obstructive Airways Disorder Overdose Sedation Sinus Tachycardia Stupor Vomiting Date:12/29/97ISR Number: 3015852-XReport Type:Expedited (15-DaCompany Report #US97123145A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Clozaril C Date:12/29/97ISR Number: 3015854-3Report Type:Expedited (15-DaCompany Report #US97124435A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Health Zyprexa PS ORAL 30.00 MG PO Disorder Professional Company Representative Date:12/29/97ISR Number: 3015856-7Report Type:Expedited (15-DaCompany Report #US97124432A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Zyprexa PS ORAL 15.00 MG No Adverse Drug Effect Professional DAILY PO Overdose Depakote C Klonopin C Date:12/29/97ISR Number: 3015859-2Report Type:Expedited (15-DaCompany Report #US97124414A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Risperdal C 24-Jun-2005 12:19 PM Page: 145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/97ISR Number: 3015861-0Report Type:Expedited (15-DaCompany Report #GB97115263A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 20.00 MG UNK Initial or Prolonged Phosphokinase Increased Health PO Body Temperature Professional Thioridazine C Increased Company Convulsion Representative Lower Respiratory Tract Infection Malaise Nervous System Disorder Neuroleptic Malignant Syndrome Pneumonia Date:12/29/97ISR Number: 3015862-2Report Type:Expedited (15-DaCompany Report #DE97103910A Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS 10.00 MG Initial or Prolonged Cardiomyopathy Paroxetine C Date:12/29/97ISR Number: 3015865-8Report Type:Expedited (15-DaCompany Report #IE97124525A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Health Professional Date:12/30/97ISR Number: 3014477-XReport Type:Expedited (15-DaCompany Report #D/97/04252/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Leponex/Clozaril PS UNSPECIFIED Professional Zyprexia SS Date:12/31/97ISR Number: 3070152-7Report Type:Periodic Company Report #9716809 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Vistaril PS ORAL 37.50 MG Professional TOTAL:TID:ORA L Olanzapine SS ORAL ORAL Lithum C Date:01/02/98ISR Number: 3014083-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Dysarthria Dysphonia Hemiparesis 24-Jun-2005 12:19 PM Page: 146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Idiopathic Thrombocytopenic Purpura Ischaemic Stroke Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS ORAL 15MG POQ HS Synthroid C Multivitamin C Date:01/02/98ISR Number: 3014210-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Zyprexa PS ORAL TABS; 20 MG Joint Stiffness PO HS Restlessness Risperdal SS ORAL TABS; 2 MG PO BID Triphasil-28 C Date:01/02/98ISR Number: 3014216-2Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Paxil PS Skb ORAL 20 MG QAM PO Hospitalization - Infection Olanzapine SS Lilly ORAL 5 MG Q HS PO Initial or Prolonged Pyrexia Risperdal SS Janssen ORAL 2MG PO BID Required Serotonin Syndrome (TAPERING) Intervention to Tremor Sinemet C Prevent Permanent Ativan C Impairment/Damage Colace C Levothyroxine C Multivitamin C Axid C Tegretol C Date:01/02/98ISR Number: 3014218-6Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parotid Gland Enlargement Olanzapine PS Lilly ORAL 15 MG PO HS Intervention to Multivitamin C Prevent Permanent Glyburide C Impairment/Damage Lithium Carbonate C Valproic Acid C Clonazepam C Humulin N C Humulin R C Date:01/02/98ISR Number: 3015542-3Report Type:Direct Company Report # Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parotid Gland Enlargement Olanzapine PS Lilly ORAL 2.5MG PO QD Intervention to (HS) Prevent Permanent Selenium C Impairment/Damage Valproate C Vitamin E C 24-Jun-2005 12:19 PM Page: 147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 3015519-8Report Type:Expedited (15-DaCompany Report #GB97112284A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Dyspnoea Health DAILY PO Metastases To Liver Professional Chlorpromazine C Neoplasm Malignant Company Fluphenazine Pulmonary Embolism Representative Decanoate C Other Reboxetine C Date:01/09/98ISR Number: 3015522-8Report Type:Expedited (15-DaCompany Report #US98010133A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS ORAL 10.00MG DAILY Professional PO Company Representative Date:01/09/98ISR Number: 3015527-7Report Type:Expedited (15-DaCompany Report #US98010283A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Representative Date:01/09/98ISR Number: 3015532-0Report Type:Expedited (15-DaCompany Report #US97103220A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS ORAL 5.00 MG 2/DAY Initial or Prolonged Blood Creatine Professional PO Phosphokinase Increased Eskalith C Coordination Abnormal Cogentin C ORAL 1.00 MG 2/D Cough PO Diarrhoea Klonopin C ORAL 2.50 MG 2/D Haematochezia PO Headache Musculoskeletal Stiffness Myalgia Nasal Congestion Nausea Neck Pain Neuroleptic Malignant Syndrome Pharyngolaryngeal Pain Photophobia Pyrexia Tremor Urinary Incontinence Vomiting 24-Jun-2005 12:19 PM Page: 148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 3015535-6Report Type:Expedited (15-DaCompany Report #IE97124525A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS ORAL PO Health Professional Date:01/09/98ISR Number: 3015539-3Report Type:Expedited (15-DaCompany Report #US97125680A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Interstitial Lung Disease Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pneumonia Professional PO Tagamet C Date:01/09/98ISR Number: 3015545-9Report Type:Expedited (15-DaCompany Report #US98010142A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zyprexa PS Acidosis Professional Nausea Vomiting Date:01/09/98ISR Number: 3016517-0Report Type:Expedited (15-DaCompany Report #US97122968A Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa PS ORAL 10.00 MG Overdose Professional DAILY PO Chlorpromazine C Methocarbamol C Prozac C Guiatuss A.C. C Date:01/09/98ISR Number: 3016519-4Report Type:Expedited (15-DaCompany Report #US97123145A Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Zyprexa PS ORAL 10.00 MG DAILY PO Toprol C Daypro C Silver Sulfadiazine C Clozaril C Date:01/09/98ISR Number: 3016521-2Report Type:Expedited (15-DaCompany Report #US97082491A Age:7 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Consumer Zyprexa PS ORAL 5.00 MG 2/DAY Pulse Absent Health PO 7 DAY Respiratory Failure Professional Diphenhydramine C Droperidol C 24-Jun-2005 12:19 PM Page: 149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 3016522-4Report Type:Expedited (15-DaCompany Report #US97124432A Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Zyprexa PS ORAL 15.00 MG Drug Toxicity Professional DAILY PO Depakote C Klonopin C Date:01/09/98ISR Number: 3016524-8Report Type:Expedited (15-DaCompany Report #IE97113664A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS Idiopathic Health Thrombocytopenic Purpura Professional Neutropenia Company Representative Date:01/09/98ISR Number: 3016526-1Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Grand Mal Convulsion Date:01/09/98ISR Number: 3016552-2Report Type:Expedited (15-DaCompany Report #GB98010028A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS ORAL 15.00 MG Initial or Prolonged Health DAILY PO 3 WK Professional Fluphenazine C Date:01/09/98ISR Number: 3016554-6Report Type:Expedited (15-DaCompany Report #NL97124912A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Fatigue Health DAILY PO Professional Cisordinol C Akineton C Date:01/09/98ISR Number: 3016555-8Report Type:Expedited (15-DaCompany Report #IL97125443A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 10.00 MG Enuresis Health DAILY PO Sedation Professional 24-Jun-2005 12:19 PM Page: 150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 4657688-XReport Type:Direct Company Report #DQRS 125734 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Zyrtec 10 Mg Pfizer PS Pfizer ORAL 1 DAILY PO Medication Error Zyprexa 10 Mg Lilly SS Lilly Date:01/12/98ISR Number: 3018569-0Report Type:Direct Company Report # Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Olanzapine PS 10MG BID Hospitalization - Phosphokinase Increased Clozaril SS Initial or Prolonged Muscle Rigidity Neuroleptic Malignant Syndrome Date:01/13/98ISR Number: 3018174-6Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa PS Eli Lilly ORAL 20 MG PO Q Hospitalization - Cardiac Enzymes Increased HS Initial or Prolonged Confusional State Adalat C Gait Disturbance Lithium Carbonate C Ketoacidosis Myocardial Infarction Polydipsia Polyuria Pulmonary Embolism Respiratory Rate Increased Restlessness Date:01/14/98ISR Number: 3016251-7Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Depakote PS ORAL 250 MG PO BID Initial or Prolonged Abnormal Zyprexa SS Thrombocytopenia Date:01/14/98ISR Number: 3016268-2Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Zyprexa PS Eli Lilly ORAL 15 MG PO QHS Hospitalization - Phosphokinase Increased Professional Initial or Prolonged Condition Aggravated Hypertension Leukocytosis Liver Function Test Abnormal Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/98ISR Number: 3016959-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flat Affect Risperidal PS ORAL 2MG PO BID; Muscle Rigidity NDC#50458-032 Psychomotor Retardation 0-01 Zyprexa SS ORAL 15 MG PO Q 9 PM; NDC# 0002-4115-33 Zyprexa SS 15MG PO Q9PM; NDC# 0002-4117-33 Date:01/15/98ISR Number: 3016133-0Report Type:Expedited (15-DaCompany Report #FR98011009A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Foreign Zyprexa PS ORAL PO Initial or Prolonged Pneumonia Health Athymil C Professional Nozinan C Lexomil C Date:01/15/98ISR Number: 3016137-8Report Type:Expedited (15-DaCompany Report #AU98010337A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS ORAL 600.00 MG Initial or Prolonged Tachycardia Health DAILY PO Other Professional Date:01/15/98ISR Number: 3016140-8Report Type:Expedited (15-DaCompany Report #US98011090A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blood Creatine Professional DAILY PO Other Phosphokinase Increased Synthroid C Clonic Convulsion Colace C Depressed Level Of Artane C Consciousness Wellbutrin C Dysarthria Fall Hypothyroidism Inappropriate Affect Muscle Rigidity Neuroleptic Malignant Syndrome Pneumonia Aspiration Pyrexia Weight Decreased Date:01/15/98ISR Number: 3016143-3Report Type:Expedited (15-DaCompany Report #US98010592A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Other Mania Consumer Tardive Dyskinesia Health 24-Jun-2005 12:19 PM Page: 152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 30.00 MG DAILY PO Mellaril C Desipramine C Date:01/15/98ISR Number: 3016146-9Report Type:Expedited (15-DaCompany Report #US98011132A Age:23 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Zyprexa PS ORAL 25.00 MG Other Professional DAILY PO Company Prozac C Representative Date:01/15/98ISR Number: 3016150-0Report Type:Expedited (15-DaCompany Report #US98010595A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Zyprexa PS Date:01/15/98ISR Number: 3017214-8Report Type:Expedited (15-DaCompany Report #US98010124A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Muscle Twitching Professional DAILY PO Pancreatitis Prozac SS 50.00 MG DAILY Omeprazole C Atenolol C Metoprolol C Ms Contin C Dilaudid C Date:01/15/98ISR Number: 3017217-3Report Type:Expedited (15-DaCompany Report #US98010436A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS ORAL 5.00 MG Professional 2/DAY PO 3 MON Other Calan C Date:01/15/98ISR Number: 3017221-5Report Type:Expedited (15-DaCompany Report #US97120754A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Health Zyprexa PS Increased Professional Lymphoma 24-Jun-2005 12:19 PM Page: 153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/98ISR Number: 3017224-0Report Type:Expedited (15-DaCompany Report #US98010442A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Other Zyprexa PS Haloperidol C Cogentin C Date:01/15/98ISR Number: 3017228-8Report Type:Expedited (15-DaCompany Report #US98010433A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pyrexia Professional PO Serotonin Syndrome Paxil C Tremor Risperdal C Sinemet C Ativan C Colace C Axid C Levothyroxine C Multivitamin C Tegretol C Date:01/15/98ISR Number: 3017231-8Report Type:Expedited (15-DaCompany Report #GB98011315A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS 15.00 MG Health DAILY 12 MON Professional Dothiepin C Company N/A C Representative Date:01/15/98ISR Number: 3017235-5Report Type:Expedited (15-DaCompany Report #GB98010670A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zyprexa PS Initial or Prolonged Overdose Health Other Professional Date:01/15/98ISR Number: 3018422-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Olanzapine PS ORAL 15MG QD PO Required Lethargy Lithium SS 600 MG BID Intervention to Deponovera C Prevent Permanent Bentotropine C Impairment/Damage Prophxdol C Nifedipine C Phetz C Metzltestzolerod C Malox C Tylenol C Trazadae C Vitamins E C 24-Jun-2005 12:19 PM Page: 154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Halolol C Date:01/20/98ISR Number: 3017897-2Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Convulsion Neonatal Date:01/20/98ISR Number: 3017900-XReport Type:Expedited (15-DaCompany Report #GB97122461A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Zyprexa PS Initial or Prolonged Chest Pain Health Circulatory Collapse Professional Electrocardiogram Abnormal Date:01/20/98ISR Number: 3017910-2Report Type:Expedited (15-DaCompany Report #US97062269A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS 10.00 Initial or Prolonged Professional MG/DAILY Company Luvox C Representative Wellburtin C Date:01/20/98ISR Number: 3017913-8Report Type:Expedited (15-DaCompany Report #US9706199A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epileptic Aura Health Zyprexa PS ORAL 10.00 Initial or Prolonged Grand Mal Convulsion Professional MG/DAILY PO 3 WK Luvox C Klonopin C Date:01/20/98ISR Number: 3018613-0Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Olanzapine PS 5 MG TID Initial or Prolonged Increased Date:01/20/98ISR Number: 3018747-0Report Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Zyprexia PS ORAL 5 MG PO QD Initial or Prolonged Pruritus Urticaria 24-Jun-2005 12:19 PM Page: 155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/98ISR Number: 3018354-XReport Type:Expedited (15-DaCompany Report #9720530 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Cardura PS ORAL 6.00 MG Initial or Prolonged Professional TOTAL; DAILY; Required ORAL Intervention to Zyprexa SS 5.00 MG Prevent Permanent TOTAL;DAILY Impairment/Damage Gabapentin C Benazepril C Lansorazole C Temazepam C Triazolam C Date:01/22/98ISR Number: 3018355-1Report Type:Expedited (15-DaCompany Report #9720530 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Cardura PS ORAL Initial or Prolonged Professional Zyprexa SS 5 MG TOTAL Required DAILY Intervention to Gabapentin C Prevent Permanent Benazepril C Impairment/Damage Lansoprazole C Temazepam C Triazolam C Date:01/22/98ISR Number: 3018400-3Report Type:Expedited (15-DaCompany Report #9720530 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erection Increased Health Cardura PS ORAL Initial or Prolonged Professional Zyprexa SS 5MG TOTAL; Required DAILY Intervention to Gabapentin C Prevent Permanent Bemazepril C Impairment/Damage Lansoprazole C Temazepam C Triazolam C Date:01/23/98ISR Number: 3018308-3Report Type:Expedited (15-DaCompany Report #US97124435A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Health Zyprexa PS ORAL 30.00 MG Disorder Professional Prozac C Company Representative Date:01/23/98ISR Number: 3018311-3Report Type:Expedited (15-DaCompany Report #US98010133A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS ORAL 10.00 MG Professional DAILY Company Haldol Decanoate C Representative 24-Jun-2005 12:19 PM Page: 156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/98ISR Number: 3018313-7Report Type:Expedited (15-DaCompany Report #US98010283A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Zyprexa PS 10.00 MG Professional DAILY PO Company Representative Date:01/23/98ISR Number: 3018316-2Report Type:Expedited (15-DaCompany Report #US98011132A Age:23 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Zyprexa PS 25.00 MG Other Professional DAILY PO Company Prozac C Representative Date:01/23/98ISR Number: 3018317-4Report Type:Expedited (15-DaCompany Report #GB98010670A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zyprexa PS Initial or Prolonged Overdose Health Other Suicide Attempt Professional Date:01/23/98ISR Number: 3018318-6Report Type:Expedited (15-DaCompany Report #GB97042461A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Zyprexa PS ORAL Hospitalization - Distress Syndrome Health Procyclidine C Initial or Prolonged Cardiac Failure Professional Paroxetine C Circulatory Collapse Other Ranitidine C Dyspnoea Ipratropium Bromide C Infection Salbutamol C Myocardial Infarction Prednisolone C Pulmonary Oedema Amiodarone C Warfarin C Paracetamol C Date:01/23/98ISR Number: 3018321-6Report Type:Expedited (15-DaCompany Report #IE97124525A Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Health Professional Date:01/23/98ISR Number: 3018323-XReport Type:Expedited (15-DaCompany Report #GB97123808A Age: Gender:Female I/FU:F Outcome PT Other Abortion Spontaneous Agitation Dermatitis Emotional Distress 24-Jun-2005 12:19 PM Page: 157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Pruritus Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS ORAL 15.00 MG Health Professional Date:01/23/98ISR Number: 3018478-7Report Type:Expedited (15-DaCompany Report #US98012299A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Zyprexa PS 5.00MG 2/DAY Increased Professional PO Pancytopenia Renal Impairment Date:01/23/98ISR Number: 3018479-9Report Type:Expedited (15-DaCompany Report #US98012686A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Health Zyprexa PS 10.00MG DAILY Cardiac Arrest Professional PO Company Neurontin C Representative Klonopin C Ambien C Doxepin C Date:01/23/98ISR Number: 3018480-5Report Type:Expedited (15-DaCompany Report #US98012353A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS 10.00MG 2/DAY Initial or Prolonged Phosphokinase Increased Professional PO Catatonia Clozaril C Muscle Rigidity Neuroleptic Malignant Syndrome Date:01/23/98ISR Number: 3018481-7Report Type:Expedited (15-DaCompany Report #DE98012440A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 30.00MG DAILY Life-Threatening Health PO Professional Date:01/23/98ISR Number: 3018482-9Report Type:Expedited (15-DaCompany Report #DE98012434A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Zyprexa PS PO Initial or Prolonged Pulmonary Oedema Health Status Epilepticus Professional 24-Jun-2005 12:19 PM Page: 158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/98ISR Number: 3018483-0Report Type:Expedited (15-DaCompany Report #FR98012491A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eyelid Oedema Foreign Zyprexa PS PO Initial or Prolonged Hypersensitivity Health Haldol C Oedema Peripheral Professional Tegretol C Pleural Rub Company Representative Date:01/23/98ISR Number: 3018484-2Report Type:Expedited (15-DaCompany Report #GB98012056A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Foreign Zyprexa PS 5.00 MG DAILY Injury Health Co-Careldopa C Professional Parkinson'S Disease C Company Representative Date:01/23/98ISR Number: 3018814-1Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Olanzapine PS 10 MG QD THEN Initial or Prolonged White Blood Cell Count Professional 15 MG QD Decreased Date:01/25/98ISR Number: 4517500-6Report Type:Direct Company Report #USP 080935 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Pfizer TAB Unevaluable Event Zyprexia SS Lilly TAB Date:01/27/98ISR Number: 3021369-9Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Zyprexa PS Lilly ORAL 10MG ORAL Initial or Prolonged Convulsion ONCE 8/25/97 Other Dizziness AT 10PM Facial Bones Fracture Synthroid C Fall Dyazide C Joint Stiffness Atenolol C Loss Of Consciousness Paxil C Paraesthesia Syncope Tremor Date:01/28/98ISR Number: 3022596-7Report Type:Direct Company Report # Age:31 YR Gender: I/FU:I Outcome PT Life-Threatening Agitation Hospitalization - Delusion Initial or Prolonged Depression 24-Jun-2005 12:19 PM Page: 159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Psychotic Disorder Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS 20MG AM 20MG PM Symmetrel C Thorazine C Ativan C Tegretol C Inderal C Date:01/28/98ISR Number: 3022744-9Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anoxia Zyprexia PS ORAL ORAL DOSE UNK Initial or Prolonged Blood Creatine Risperidal SS ORAL ORAL DOSE UNK Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Encephalopathy Laceration Neuroleptic Malignant Syndrome Respiratory Distress White Blood Cell Count Increased Date:01/29/98ISR Number: 3020573-3Report Type:Expedited (15-DaCompany Report #DE98012440A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 30.00 MG Drug Interaction Health DAILY PO Suicide Attempt Professional Date:01/29/98ISR Number: 3021106-8Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Zyprexa PS Hospitalization - Overdose Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:01/29/98ISR Number: 3022013-7Report Type:Expedited (15-DaCompany Report #HU98013196A Age:60 YR Gender:Female I/FU:I Outcome PT Death Hepatic Function Abnormal Loss Of Consciousness Neuroleptic Malignant Syndrome 24-Jun-2005 12:19 PM Page: 160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS ORAL 10.00 MG Health DAILY Professional Risperdal C Company Representative Date:01/29/98ISR Number: 3022094-0Report Type:Expedited (15-DaCompany Report #US98011090A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Asthenia Professional DAILY PO Other Blood Creatine Synthroid C Phosphokinase Increased Colace C Cerebral Cyst Artane C Clonic Convulsion Wellbutrin C Depressed Level Of Consciousness Drooling Dysphagia Extrapyramidal Disorder Fall Hypothyroidism Inappropriate Affect Muscle Rigidity Mutism Neuroleptic Malignant Syndrome Pneumonia Aspiration Pyrexia Salivary Hypersecretion Stupor Weight Decreased Date:01/29/98ISR Number: 3022095-2Report Type:Expedited (15-DaCompany Report #US98013694A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Zyprexa PS ORAL 30.00 MG DAILY Luvox C Lithium C Ativan C Buspar C Date:01/29/98ISR Number: 3022096-4Report Type:Expedited (15-DaCompany Report #DE98013913A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Foreign Zyprexa PS ORAL 230.00 MG Initial or Prolonged Intentional Misuse Health Other Restlessness Professional Tachycardia 24-Jun-2005 12:19 PM Page: 161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/98ISR Number: 3022097-6Report Type:Expedited (15-DaCompany Report #SE98013496A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa PS Other Date:01/29/98ISR Number: 3022098-8Report Type:Expedited (15-DaCompany Report #GB98013316A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Ventricular Arrhythmia Health DAILY PO Professional Periciazine C Lithium Carbonate C Frusemide C Atenolol C Glyceryl Trinitrate C Thyroxin C Lorazepam C Sertraline C Peppermint Oil C Loperamide C Carbamazepine C Valproate Sodium C Procyclidine C Date:01/29/98ISR Number: 3022099-XReport Type:Expedited (15-DaCompany Report #DE98014138A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS ORAL 10.00 MG Health Professional Date:01/29/98ISR Number: 3022100-3Report Type:Expedited (15-DaCompany Report #IT98013730A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa PS ORAL 15.00 MG Murder Health DAILY PO Professional Samyr C Alprazolam C Date:01/29/98ISR Number: 3022101-5Report Type:Expedited (15-DaCompany Report #DE98013577A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 10 MG UNK PO Drug Ineffective Literature Hallucination Health Professional 24-Jun-2005 12:19 PM Page: 162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/98ISR Number: 3022102-7Report Type:Expedited (15-DaCompany Report #GB97123808A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zyprexa PS ORAL 15.00 MG PO Complications Of Maternal Health Exposure To Therapeutic Professional Drugs Other Dermatitis Pruritus Date:01/29/98ISR Number: 3022131-3Report Type:Expedited (15-DaCompany Report #CL98013079A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional Zopiclone C Date:01/29/98ISR Number: 3022132-5Report Type:Expedited (15-DaCompany Report #US98013085A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Below Health Zyprexa PS ORAL 25.00 MG Therapeutic Professional DAILY PO Tegretol C Klonopin C Paxil C Theophylline C Date:01/30/98ISR Number: 3021439-5Report Type:Expedited (15-DaCompany Report #US97106025A Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Ciprofloxacin C Haldol C Date:01/30/98ISR Number: 3021440-1Report Type:Expedited (15-DaCompany Report #US97106061A Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa PS ORAL 10.OO DAILY Hospitalization - Professional Carbidopa C Initial or Prolonged Levodopa C Date:01/30/98ISR Number: 3021441-3Report Type:Expedited (15-DaCompany Report #FI96115119A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Foreign Zyprexa PS ORAL 10.OO MG Initial or Prolonged Convulsions Health DAILY PO Nausea Professional Diazepam C Vertigo Carbamazepine C Vomiting Nitrazepam C Valproic Acid C 24-Jun-2005 12:19 PM Page: 163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3021443-7Report Type:Expedited (15-DaCompany Report #GB97122461A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS ORAL Initial or Prolonged Circulatory Collapse Health Electrocardiogram T Wave Professional Peaked Myocardial Infarction Date:01/30/98ISR Number: 3021444-9Report Type:Expedited (15-DaCompany Report #US97121063A Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Study Zyprexa PS ORAL 10.00 MG Life-Threatening Abdominal Pain Upper Health DAILY PO Hospitalization - Faecaloma Professional Magnesium Citrate C Initial or Prolonged Intestinal Obstruction Bisacodyl C Pneumonia Aspiration Milk Of Magnesia C Urinary Tract Obstruction Demerol C Phenergan C Dulcolax C Lanoxin C Diflucan C Lorabid C Proventil C Duragesic C Reglan C Date:01/30/98ISR Number: 3021531-5Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Omeprazole PS 20 MG BID Initial or Prolonged Confusional State Professional Olanzapine SS 10 MG QD Delusion Drug Interaction Date:01/30/98ISR Number: 3021560-1Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS Lilly ORAL 40 MG PO QD 4 MON Initial or Prolonged Arrhythmia Professional Dilantin C Liver Function Test Prozac C Abnormal Furosemide C Nausea Supraventricular Tachycardia Vomiting Date:01/30/98ISR Number: 3088922-8Report Type:Periodic Company Report #US97115044A Age:36 YR Gender:Male I/FU:I Outcome PT Alopecia Dermatitis Systemic Lupus 24-Jun-2005 12:19 PM Page: 164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erythematosus Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Klonopin C Buspar C Cogentin C Paxil C Date:01/30/98ISR Number: 3088924-1Report Type:Periodic Company Report #US97115095A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Abnormal Health DAILY PO Professional Zoloft C Lithium Carbonate C Date:01/30/98ISR Number: 3088926-5Report Type:Periodic Company Report #US97115107A Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apathy Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Depression Health DAILY PO Professional Zoloft C Tegretol C Date:01/30/98ISR Number: 3088928-9Report Type:Periodic Company Report #US97115110A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG DAILY PO Zoloft C Date:01/30/98ISR Number: 3088931-9Report Type:Periodic Company Report #US97115113A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG DAILY PO Dilantin C Serzone C Date:01/30/98ISR Number: 3088933-2Report Type:Periodic Company Report #US97115158A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa PS Eli Lilly And Co ORAL 30.00 MG Professional DAILY PO 1 WK 24-Jun-2005 12:19 PM Page: 165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3088935-6Report Type:Periodic Company Report #US97115173A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertonia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Company Depakote C Representative Date:01/30/98ISR Number: 3088938-1Report Type:Periodic Company Report #US97115179A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypercholesterolaemia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Hyperlipidaemia Professional DAILY PO Symmetrel C Depakote C Date:01/30/98ISR Number: 3088941-1Report Type:Periodic Company Report #US97115182A Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Consumer Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY Pollakiuria Health PO Weight Increased Professional Albuterol C Asthma C Zithromax C Ritalin C Tenex C Clonidine C Date:01/30/98ISR Number: 3088944-7Report Type:Periodic Company Report #US97115185A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Apnoea Health PO Asthma Professional Ritalin C Drug Ineffective Prozac C Dyspnoea Weight Increased Date:01/30/98ISR Number: 3088947-2Report Type:Periodic Company Report #US97120118A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3088950-2Report Type:Periodic Company Report #US97120175A Age: Gender:Female I/FU:I Outcome PT Report Source Buccoglossal Syndrome Health Movement Disorder Professional 24-Jun-2005 12:19 PM Page: 166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Haldol C Cogentin C Date:01/30/98ISR Number: 3088954-XReport Type:Periodic Company Report #US97120187A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Date:01/30/98ISR Number: 3088956-3Report Type:Periodic Company Report #US971`20250A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO 5 MON Effexor C Depakote C Date:01/30/98ISR Number: 3088959-9Report Type:Periodic Company Report #US97120265A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Company Luvox C Representative Date:01/30/98ISR Number: 3088960-5Report Type:Periodic Company Report #US97120283A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS Eli Lilly And Co ORAL 2.50 MG 2/DAY Constipation Health PO Dry Mouth Professional Wellbutrin C Insomnia Ambien C Prilosec C Date:01/30/98ISR Number: 3088964-2Report Type:Periodic Company Report #US97120577A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neurosis Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Stupor Professional PO Thirst Serzone C Cylert C Synthroid C 24-Jun-2005 12:19 PM Page: 167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3088966-6Report Type:Periodic Company Report #US97120580A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS Eli Lilly And Co 2 MON Professional Date:01/30/98ISR Number: 3088968-XReport Type:Periodic Company Report #US97120583A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Weight Increased Professional DAILY PO Depakote C Date:01/30/98ISR Number: 3088970-8Report Type:Periodic Company Report #US97120607A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Nervousness PO Sedation Artane C Date:01/30/98ISR Number: 3088973-3Report Type:Periodic Company Report #US97120829A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3088974-5Report Type:Periodic Company Report #US97120844A Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Date:01/30/98ISR Number: 3088977-0Report Type:Periodic Company Report #US97120850A Age:51 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Depakote C Date:01/30/98ISR Number: 3088980-0Report Type:Periodic Company Report #US97120862A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myocarditis Health Zyprexa PS Eli Lilly And Co Professional Luvox C 24-Jun-2005 12:19 PM Page: 168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3088982-4Report Type:Periodic Company Report #US97120865A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Migraine Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Synthroid C Date:01/30/98ISR Number: 3088986-1Report Type:Periodic Company Report #US97120871A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS Eli Lilly And Co 2 MON Professional Date:01/30/98ISR Number: 3088989-7Report Type:Periodic Company Report #US97120877A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3088990-3Report Type:Periodic Company Report #US97120880A Age:14 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Urinary Incontinence Professional 2/DAY PO Luvox C Date:01/30/98ISR Number: 3088993-9Report Type:Periodic Company Report #US97120883A Age:14 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgeusia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional 2/DAY PO Luvox C Date:01/30/98ISR Number: 3089010-7Report Type:Periodic Company Report #US97120886A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Prozac SS ORAL 80.00 MG DAILY PO Date:01/30/98ISR Number: 3089012-0Report Type:Periodic Company Report #US97120889A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Neuroleptic Malignant Health Syndrome Professional Company 24-Jun-2005 12:19 PM Page: 169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5.00 MG 3 DAY Prolixin C Ativan C Cogentin C Tylenol C Date:01/30/98ISR Number: 3089016-8Report Type:Periodic Company Report #US97121114A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG PO Professional Company Representative Date:01/30/98ISR Number: 3089018-1Report Type:Periodic Company Report #US97121120A Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Company Clozaril C Representative Paxil C Date:01/30/98ISR Number: 3089019-3Report Type:Periodic Company Report #US97121126A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Lung Disorder Professional DAILY PO Pulmonary Oedema Trazodone C Prozac C Premarin C Klonopin C Date:01/30/98ISR Number: 3089022-3Report Type:Periodic Company Report #US97121135A Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional 2/DAY PO Luvox C Date:01/30/98ISR Number: 3089024-7Report Type:Periodic Company Report #US97121141A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Odour Abnormal Consumer Zyprexa PS Eli Lilly And Co 24-Jun-2005 12:19 PM Page: 170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089025-9Report Type:Periodic Company Report #US97121147A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Thinking Abnormal DAILY PO Depakote C Klonopin C Date:01/30/98ISR Number: 3089026-0Report Type:Periodic Company Report #US97121150A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Company Representative Date:01/30/98ISR Number: 3089029-6Report Type:Periodic Company Report #US97121156A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Professional Company Representative Date:01/30/98ISR Number: 3089031-4Report Type:Periodic Company Report #US97121162A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paranoia Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 2/DAY PO Lithium C Paxil C Trazodone C Date:01/30/98ISR Number: 3089032-6Report Type:Periodic Company Report #US97121186A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Consumer Zyprexa PS Eli Lilly And Co Face Oedema Multivitamin C Nervousness Speech Disorder Tremor Date:01/30/98ISR Number: 3089035-1Report Type:Periodic Company Report #SPEECH DISORDER Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Consumer Zyprexa PS Eli Lilly And Co Altace C Prilosec C Norvasc C 24-Jun-2005 12:19 PM Page: 171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089036-3Report Type:Periodic Company Report #US97121384A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Weight Increased Prozac C Date:01/30/98ISR Number: 3089039-9Report Type:Periodic Company Report #US97121486A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Thinking Abnormal Health DAILY PO Professional Cogentin C Date:01/30/98ISR Number: 3089041-7Report Type:Periodic Company Report #US97121651A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Weight Increased DAILY PO Ritalin C Prozac C Date:01/30/98ISR Number: 3089044-2Report Type:Periodic Company Report #US97121744A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Thinking Abnormal DAILY PO Weight Increased Date:01/30/98ISR Number: 3089046-6Report Type:Periodic Company Report #US97121750A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Consumer Zyprexa PS Eli Lilly And Co 10.00 MG Sedation Date:01/30/98ISR Number: 3089048-XReport Type:Periodic Company Report #US97121849A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Health Zyprexa PS Eli Lilly And Co 10.00 MG Muscle Spasms Professional Company Representative Date:01/30/98ISR Number: 3089051-XReport Type:Periodic Company Report #US97121861A Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co 5.00 MG DAILY 24-Jun-2005 12:19 PM Page: 172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089052-1Report Type:Periodic Company Report #US97121867A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Other Zyprexa PS Eli Lilly And Co Unevaluable Event Haldol C Date:01/30/98ISR Number: 3089053-3Report Type:Periodic Company Report #US97121879A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089055-7Report Type:Periodic Company Report #US97121885A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa PS Eli Lilly And Co ORAL 25.00 MG Professional DAILY PO 2 MON Date:01/30/98ISR Number: 3089056-9Report Type:Periodic Company Report #US97121996A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Hostility DAILY PO Sedation Dilantin C Weight Increased Ativan C Date:01/30/98ISR Number: 3089059-4Report Type:Periodic Company Report #US97122059A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Consumer Zyprexa PS Eli Lilly And Co 5.00 MG DAILY Rectal Haemorrhage Health Dexedrine C Professional Clonidine C Depakote C Date:01/30/98ISR Number: 3089061-2Report Type:Periodic Company Report #US97122071A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Anxiety Professional DAILY PO Depression Haldol C Drug Ineffective Paxil C Naprosyn C Date:01/30/98ISR Number: 3089064-8Report Type:Periodic Company Report #US97122080A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Consumer Zyprexa PS Eli Lilly And Co ORAL 25.00 MG Unintended Pregnancy DAILY PO 24-Jun-2005 12:19 PM Page: 173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089067-3Report Type:Periodic Company Report #US97122101A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Muscle Rigidity Ferrous Sulfate C Tremor Gentamicicn Ophthalmic Solution C Dulcolax C Vitamin E C Multivitamin C Oxybutynin C Lorazepam C Lactulose C Peri-Colace C Date:01/30/98ISR Number: 3089069-7Report Type:Periodic Company Report #US97122191A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Visual Disturbance Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG 2 Professional /DAY PO Pravachol C Synthroid C Date:01/30/98ISR Number: 3089071-5Report Type:Periodic Company Report #US97122203A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089073-9Report Type:Periodic Company Report #US97122218A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Coordination Abnormal Professional DAILY PO Diarrhoea Lithium C Tremor Propranolol C Vomiting Levothyroxine C Date:01/30/98ISR Number: 3089075-2Report Type:Periodic Company Report #US97122227A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089076-4Report Type:Periodic Company Report #US97122236A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089077-6Report Type:Periodic Company Report #US97122245A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089078-8Report Type:Periodic Company Report #US97122281A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Lithium C Haldol Deconoate C Prozac C Date:01/30/98ISR Number: 3089080-6Report Type:Periodic Company Report #US97122290A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Health Zyprexa PS Eli Lilly And Co Professional Maxzide C Date:01/30/98ISR Number: 3089082-XReport Type:Periodic Company Report #US97122299A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accident Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Orthostatic Hypotension Professional PO Sedation Lorazepam C Weight Decreased Date:01/30/98ISR Number: 3089085-5Report Type:Periodic Company Report #US97122347A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa PS Eli Lilly And Co ORAL 7.50 MG DAILY Extrapyramidal Disorder Professional PO Sedation Buspirone C Amlodipine C Aspirin C Atenolol C Ranitidine C Sinemet - Slow Release C Date:01/30/98ISR Number: 3089088-0Report Type:Periodic Company Report #US97122359A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 17.50 MG Pollakiuria Professional DAILY Thirst Luvox C Lithium C 24-Jun-2005 12:19 PM Page: 175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089107-1Report Type:Periodic Company Report #US97122374A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Stupor Professional DAILY PO Metolazone C Captopril C Date:01/30/98ISR Number: 3089108-3Report Type:Periodic Company Report #US97122428A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa PS Eli Lilly And Co ORAL DAILY PO Date:01/30/98ISR Number: 3089111-3Report Type:Periodic Company Report #US97122434A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Gastritis DAILY PO Xanax C Date:01/30/98ISR Number: 3089113-7Report Type:Periodic Company Report #US97122437A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089116-2Report Type:Periodic Company Report #US97122539A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Glucophage C Date:01/30/98ISR Number: 3089119-8Report Type:Periodic Company Report #US97122542A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co Professional Glipizide C Date:01/30/98ISR Number: 3089121-6Report Type:Periodic Company Report #US97122551A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089125-3Report Type:Periodic Company Report #US97122620A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089127-7Report Type:Periodic Company Report #US97122632A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Professional Date:01/30/98ISR Number: 3089130-7Report Type:Periodic Company Report #US97122635A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3089131-9Report Type:Periodic Company Report #US97122644A Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO 1 DAY Sedation Professional Date:01/30/98ISR Number: 3089133-2Report Type:Periodic Company Report #US97122653A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089194-0Report Type:Periodic Company Report #US97122659A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Hallucination Professional Company Representative Date:01/30/98ISR Number: 3089195-2Report Type:Periodic Company Report #US97122662A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089196-4Report Type:Periodic Company Report #US97122665A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089197-6Report Type:Periodic Company Report #US97122668A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Below Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Therapeutic Professional DAILY PO Dilantin C Phenobarbital C Omeprazole C Cascara C Lactulose C Milk Of Magnesia C Date:01/30/98ISR Number: 3089198-8Report Type:Periodic Company Report #US97122686A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Micturition Urgency Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Desyrel C Benadryl C Docusate C Calcium C Vitamin E C Vitamin C C Multivitamins W/Minerals C Griseofulvin C Date:01/30/98ISR Number: 3089199-XReport Type:Periodic Company Report #US97122890A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Thinking Abnormal PO Lithium C Lorazepam C Date:01/30/98ISR Number: 3089200-3Report Type:Periodic Company Report #US97123028A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Eye Disorder Health DAILY PO Headache Professional Sedation 24-Jun-2005 12:19 PM Page: 178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089201-5Report Type:Periodic Company Report #US97123031A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Clonic Convulsion Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Muscle Twitching Professional DAILY PO 3 WK Paraesthesia Depakote C Lithium C Insulin C Date:01/30/98ISR Number: 3089202-7Report Type:Periodic Company Report #US97123352A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG PO Professional Prozac C Date:01/30/98ISR Number: 3089203-9Report Type:Periodic Company Report #US97123448A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co Pyrexia Professional Date:01/30/98ISR Number: 3089204-0Report Type:Periodic Company Report #US97123547A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Consumer Zyprexa PS Eli Lilly And Co ORAL 12.50 MG Health DAILY PO Professional Risperdal C Carbamazepine C Diphenhydramine C Date:01/30/98ISR Number: 3089205-2Report Type:Periodic Company Report #US97123556A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Pyrexia Health PO Weight Decreased Professional Date:01/30/98ISR Number: 3089206-4Report Type:Periodic Company Report #US97123574A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3089207-6Report Type:Periodic Company Report #US97123592A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Jaundice Health Zyprexa PS Eli Lilly And Co ORAL 7.50 MG DAILY Liver Function Test Professional PO Abnormal 24-Jun-2005 12:19 PM Page: 179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089208-8Report Type:Periodic Company Report #US97123673A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Remeron C Lorazepam C Date:01/30/98ISR Number: 3089209-XReport Type:Periodic Company Report #US97123733A Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089210-6Report Type:Periodic Company Report #US97123757A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG DAILY PO 1 MON Cogentin C Date:01/30/98ISR Number: 3089211-8Report Type:Periodic Company Report #US97123793A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Health Zyprexa PS Eli Lilly And Co Professional Company Representative Other Date:01/30/98ISR Number: 3089212-XReport Type:Periodic Company Report #US97123799A Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Health Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY Weight Increased Professional PO Ritalin C Clonidine C Tofranil C Inderal C Date:01/30/98ISR Number: 3089213-1Report Type:Periodic Company Report #US97123811A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Increased Professional DAILY PO Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089214-3Report Type:Periodic Company Report #US97123814A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Hypoproteinaemia Professional PO Amantadine C Dilantin C Prozac C Date:01/30/98ISR Number: 3089220-9Report Type:Periodic Company Report #US97123817A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3089222-2Report Type:Periodic Company Report #US97123832A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Personality Disorder Consumer Zyprexa PS Eli Lilly And Co ORAL PO Date:01/30/98ISR Number: 3089223-4Report Type:Periodic Company Report #US97123835A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO 1 WK Ativan C Date:01/30/98ISR Number: 3089225-8Report Type:Periodic Company Report #US97123838A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY Professional PO Paxil C Date:01/30/98ISR Number: 3089227-1Report Type:Periodic Company Report #US97123841A Age:22 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3091930-4Report Type:Periodic Company Report #US97123844A Age:34 YR Gender:Male I/FU:I Outcome PT Leukopenia Myalgia 24-Jun-2005 12:19 PM Page: 181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Ativan C Date:01/30/98ISR Number: 3091932-8Report Type:Periodic Company Report #US97124021A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co 7.50 MG DAILY Professional Depakote C Vitamin E C Prolixin C Cogentin C Date:01/30/98ISR Number: 3091934-1Report Type:Periodic Company Report #US97124039A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Professional DAILY PO Haldol C Amantadine C Tegretol C Dilantin C Date:01/30/98ISR Number: 3091936-5Report Type:Periodic Company Report #US97124108A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Prolixin Decaonate C Cogentin C Benadryl C Depakote C Prozac C Klonopin C Redux C Date:01/30/98ISR Number: 3091939-0Report Type:Periodic Company Report #US97124150A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3091942-0Report Type:Periodic Company Report #US97124156A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Cogentin C 24-Jun-2005 12:19 PM Page: 182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stelazine C Trazodone C Zoloft C Date:01/30/98ISR Number: 3091945-6Report Type:Periodic Company Report #US97124615A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Health Zyprexa PS Eli Lilly And Co 5.00 MG Professional Company Representative Date:01/30/98ISR Number: 3091950-XReport Type:Periodic Company Report #US97124702A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO 2 MON Professional Date:01/30/98ISR Number: 3091953-5Report Type:Periodic Company Report #US97124711A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Date:01/30/98ISR Number: 3091956-0Report Type:Periodic Company Report #US97124720A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Increased Professional DAILY PO Hypertension Lithium C Tachycardia Valproic Acid C Hyzaar C Date:01/30/98ISR Number: 3091958-4Report Type:Periodic Company Report #US97124747A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Company Representative Date:01/30/98ISR Number: 3091962-6Report Type:Periodic Company Report #US97124756A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Positive Professional DAILY PO Vasculitis 24-Jun-2005 12:19 PM Page: 183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3091966-3Report Type:Periodic Company Report #US97124762A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co 20.00 MG Professional DAILY Lithium C Ativan C Anafranil C Date:01/30/98ISR Number: 3091980-8Report Type:Periodic Company Report #US97124765A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Vitamins C Date:01/30/98ISR Number: 3091982-1Report Type:Periodic Company Report #US97124801A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3091983-3Report Type:Periodic Company Report #US97124816A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS Eli Lilly And Co 10.00 MG Injury Professional Mellaril C Nervousness Company Benadryl C Representative Date:01/30/98ISR Number: 3091989-4Report Type:Periodic Company Report #US97124840A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3091992-4Report Type:Periodic Company Report #US97125095A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Company Ativan C Representative Effexor C 24-Jun-2005 12:19 PM Page: 184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3091994-8Report Type:Periodic Company Report #US97125203A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Health PO Professional Date:01/30/98ISR Number: 3091996-1Report Type:Periodic Company Report #US97125230A Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Prozac C Lithium C Date:01/30/98ISR Number: 3091998-5Report Type:Periodic Company Report #US97125386A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Hostility Professional DAILY PO Movement Disorder Depakote C Date:01/30/98ISR Number: 3092001-3Report Type:Periodic Company Report #US97125395A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Faeces Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3092005-0Report Type:Periodic Company Report #US97125401A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG PO Oedema Peripheral Health Zoloft C Paraesthesia Professional Sedation Date:01/30/98ISR Number: 3092009-8Report Type:Periodic Company Report #US97125407A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa PS Eli Lilly And Co 20.00 DAILY Paranoia Professional Tranxene C Date:01/30/98ISR Number: 3092013-XReport Type:Periodic Company Report #US97125461A Age:48 YR Gender:Male I/FU:I Outcome PT Confusional State Coordination Abnormal 24-Jun-2005 12:19 PM Page: 185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Skin Discolouration Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Depakote C Cogentin C Date:01/30/98ISR Number: 3092016-5Report Type:Periodic Company Report #US97125419A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Hypertonia Professional DAILY PO Masked Facies Depakote C Tremor Inderal C Date:01/30/98ISR Number: 3092021-9Report Type:Periodic Company Report #US97125425A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Health Zyprexa PS Eli Lilly And Co 17 DAY Increased Appetite Professional Libido Decreased Other Sedation Date:01/30/98ISR Number: 3092024-4Report Type:Periodic Company Report #US97125725A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Consumer Zyprexa PS Eli Lilly And Co ORAL 18.75 MG Apathy Health DAILY PO Hallucination Professional Mevacor C Nervousness Ecotrin C Sedation Centrum C Lorazepam C Effexor C Date:01/30/98ISR Number: 3092028-1Report Type:Periodic Company Report #US97125734A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3092031-1Report Type:Periodic Company Report #US97125746A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Amitriptyline C 24-Jun-2005 12:19 PM Page: 186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092032-3Report Type:Periodic Company Report #US97125773A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Phosphokinase Increased Professional DAILY PO Blood Creatinine Verapamil C Increased Paxil C Myopathy Tenex C Anafranil C Beclovent C Flovent C Serevent C Atrovent C Albuterol C Albuterol C Synthroid C Digoxin C Date:01/30/98ISR Number: 3092037-2Report Type:Periodic Company Report #US98010271A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS Eli Lilly And Co Weight Increased Date:01/30/98ISR Number: 3092040-2Report Type:Periodic Company Report #US98010313A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS Eli Lilly And Co Professional Lithium C Trazodone C Serzone C Date:01/30/98ISR Number: 3092044-XReport Type:Periodic Company Report #US98010316A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deafness Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Zoloft C Trilafon C Date:01/30/98ISR Number: 3092047-5Report Type:Periodic Company Report #US97101183A Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Consumer Zyprexa PS ORAL 40.00 MG Urinary Incontinence Health DAILY PO 6 MON Professional Clozaril C Bethanechol C 24-Jun-2005 12:19 PM Page: 187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092051-7Report Type:Periodic Company Report #US97101204A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Hyperglycaemia Professional DAILY PO 10 MON Lamictal C Lithium C Date:01/30/98ISR Number: 3092055-4Report Type:Periodic Company Report #US97101213A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 7.50 MG DAILY Initial or Prolonged Dysphagia Professional PO Hyperhidrosis Other Trazodone C Hyperventilation Risperdal C Pyrexia Sedation Tachycardia Date:01/30/98ISR Number: 3092058-XReport Type:Periodic Company Report #US97101894A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Aspartate Professional DAILY PO 5 WK Aminotransferase Clozapine C Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Hyponatraemia Leukocytosis Myopathy Neuroleptic Malignant Syndrome Pneumonia Pyrexia Thinking Abnormal Date:01/30/98ISR Number: 3092060-8Report Type:Periodic Company Report #US97102434A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Zyprexa PS ORAL 150.00 MG Dizziness Professional DAILY PO Intentional Misuse Depakote C Sedation Effexor C Date:01/30/98ISR Number: 3092062-1Report Type:Periodic Company Report #US97102728A Age:80 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Chest Pain 24-Jun-2005 12:19 PM Page: 188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Choreoathetosis Dyskinesia Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration Hypertonia Health Zyprexa PS ORAL 5.00 MG DAILY Hyperventilation Professional PO Hypokalaemia Company Colace C Hypoproteinaemia Representative Naprosyn C Hypotension Tamoxifen C Leukocytosis Congentin C Liver Function Test Tylenol C Abnormal Muscle Rigidity Nausea Neuroleptic Malignant Syndrome Pyrexia Salivary Hypersecretion Tachycardia Trismus Vomiting Date:01/30/98ISR Number: 3092064-5Report Type:Periodic Company Report #US97102800A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Zyprexa PS ORAL 50.00 MG Sedation Professional DAILY PO Company Clozaril C Representative Date:01/30/98ISR Number: 3092066-9Report Type:Periodic Company Report #US97103511A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Zyprexa PS ORAL 25.00 MG Back Pain DAILY PO Intentional Misuse Depakote C Muscle Twitching Lamicatal C Pyrexia Congentin C Speech Disorder Tremor Date:01/30/98ISR Number: 3092068-2Report Type:Periodic Company Report #US97103727A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Consumer Zyprexa PS ORAL 40.00 MG Nervousness DAILY PO Tegretol C Lithium C Prozac C Haldol C 24-Jun-2005 12:19 PM Page: 189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092069-4Report Type:Periodic Company Report #US97104543A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Zyprexa PS Initial or Prolonged Health Fluphenazine C Professional Insulin C Date:01/30/98ISR Number: 3092071-2Report Type:Periodic Company Report #US97104924A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 30.00 MG Initial or Prolonged Professional DAILY PO Other Synthroid C Dilantin C Risperdal C Lithium C Clonidine C Date:01/30/98ISR Number: 3092073-6Report Type:Periodic Company Report #US97105080A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Dystonia Professional DAILY PO 2 MON Date:01/30/98ISR Number: 3092076-1Report Type:Periodic Company Report #US97105842A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Zyprexa PS Syncope Professional Date:01/30/98ISR Number: 3092080-3Report Type:Periodic Company Report #US97106718A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS ORAL 15.00 MG Initial or Prolonged Drug Interaction Professional DAILY PO Hyperglycaemia Company Depakote C Thirst Representative Micronase C Urinary Incontinence Propranolol C Date:01/30/98ISR Number: 3092083-9Report Type:Periodic Company Report #US97106748A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Zyprexa PS ORAL 150.00 MG 1/ Intentional Misuse Professional PO 24-Jun-2005 12:19 PM Page: 190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092087-6Report Type:Periodic Company Report #US97106763A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS Initial or Prolonged Nausea Professional Prozac C Other Sedation Tachycardia Date:01/30/98ISR Number: 3092090-6Report Type:Periodic Company Report #US97111450A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa PS 10.00 MG Initial or Prolonged Gait Disturbance Professional DAILY Tremor Ativan C Lithium C Depakote C Date:01/30/98ISR Number: 3092095-5Report Type:Periodic Company Report #US97111729A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Zyprexa PS ORAL 35.00 MG Weight Increased Professional DAILY PO 1 YR Paxil C Depakote C Date:01/30/98ISR Number: 3092097-9Report Type:Periodic Company Report #US97112431A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS ORAL 200.00 MG 1 / Initial or Prolonged Liver Function Test Professional PO Other Sedation Date:01/30/98ISR Number: 3092100-6Report Type:Periodic Company Report #US97112467A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO Choreoathetosis Haldol Decanoate C Dyskinesia Congentin C Hyperhidrosis Benadryl C Hypertension Cocaine C Hypertonia Hyperventilation Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Sedation Stupor Tachycardia Tremor Urinary Incontinence 24-Jun-2005 12:19 PM Page: 191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092102-XReport Type:Periodic Company Report #US97113046A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS 1 YR Initial or Prolonged Decreased Appetite Professional Diabetic Ketoacidosis Ketonuria Nausea Polydipsia Polyuria Vomiting Date:01/30/98ISR Number: 3092106-7Report Type:Periodic Company Report #US97113076A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa PS Professional Date:01/30/98ISR Number: 3092109-2Report Type:Periodic Company Report #US97113514A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Zyprexa PS ORAL 25.00 MG Arthralgia DAILY PO 1 YR Nasal Congestion Levoxyl C Sedation Vision Blurred Weight Increased Date:01/30/98ISR Number: 3092113-4Report Type:Periodic Company Report #US97114108A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS ORAL 10.00 MG Syndrome Professional DAILY PO Date:01/30/98ISR Number: 3092117-1Report Type:Periodic Company Report #US97114372A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Delirium Professional DAILY PO 3 MON Diabetes Mellitus Lorazepam C Date:01/30/98ISR Number: 3092121-3Report Type:Periodic Company Report #US97121342A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Zyprexa PS 40.00 MG Professional DAILY 24-Jun-2005 12:19 PM Page: 192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092126-2Report Type:Periodic Company Report #US97121345A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Health Zyprexa PS ORAL 25.00 MG Professional 3/WEEK PO Zoloft C Aricept C Date:01/30/98ISR Number: 3092131-6Report Type:Periodic Company Report #US97122098A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Health Zyprexa PS 40.00 MG Hyperbilirubinaemia Professional DAILY Intentional Misuse Company Representative Date:01/30/98ISR Number: 3092134-1Report Type:Periodic Company Report #US97122671A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Fall Professional DAILY PO 4 MON Lethargy Zoloft C Muscle Rigidity Pamelor C Mutism Ritalin C Neuroleptic Malignant Syndrome Pyrexia Date:01/30/98ISR Number: 3092137-7Report Type:Periodic Company Report #US97123277A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Health Zyprexa PS ORAL 15.00 MG Hospitalization - Muscle Rigidity Professional DAILY PO Initial or Prolonged Neuroleptic Malignant Inderal La C Syndrome Amantadine C Pyrexia Cardura C Cogentin C Antacid C Tylenol C Multivitamin C Ativan C Perphenazine C Date:01/30/98ISR Number: 3092140-7Report Type:Periodic Company Report #US97123682A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa PS 3 DAY Phosphokinase Increased Professional Wellbutrin C Delirium Trazodone C Neuroleptic Malignant Syndrome White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092143-2Report Type:Periodic Company Report #US97123727A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Consumer Zyprexa PS ORAL 25.00 MG Health DAILY PO Professional Cardura C Desyrel C Aspirin C Date:01/30/98ISR Number: 3092148-1Report Type:Periodic Company Report #US97124360A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flushing Health Zyprexa PS ORAL 5.00 MG DAILY Psychomotor Hyperactivity Professional PO Retching Sedation Date:01/30/98ISR Number: 3092152-3Report Type:Periodic Company Report #US97124417A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Syndrome Professional PO 1 WK Company Navane C Representative Date:01/30/98ISR Number: 3092157-2Report Type:Periodic Company Report #US97124423A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchospasm Health Zyprexa PS ORAL 40.00 MG Dysphagia Professional DAILY PO Pneumonia Aspiration Clozapine C Date:01/30/98ISR Number: 3092165-1Report Type:Periodic Company Report #US97124600A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Zyprexa PS ORAL 70.00 MG Vision Blurred Health DAILY PO Professional Depakote C Date:01/30/98ISR Number: 3092168-7Report Type:Periodic Company Report #US97100685A Age:80 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Monocyte Count Increased Neutrophil Count 24-Jun-2005 12:19 PM Page: 194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Pulmonary Congestion Tachycardia White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Study Zyprexa PS ORAL 5.00 MG DAILY Health PO Professional Levothyroxine C Propulsid C Haldol C Zyprexa C Date:01/30/98ISR Number: 3092172-9Report Type:Periodic Company Report #US97101570A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Stress Disorder Study Zyprexa PS ORAL 15.00 MG Hospitalization - Suicidal Ideation Health DAILY PO Initial or Prolonged Professional Motrin C Tylenol C Date:01/30/98ISR Number: 3092175-4Report Type:Periodic Company Report #US97101897A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Eye Disorder Health DAILY PO Other Flat Affect Professional Trazodone C Hallucination Insomnia C Salivary Hypersecretion Risperidone C Suicidal Ideation Docusate Sodium C Levobunolol C Depakote C Tylenol C Date:01/30/98ISR Number: 3092180-8Report Type:Periodic Company Report #US97102089A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS ORAL 20.00 MG PO Initial or Prolonged Health Advil C Professional Date:01/30/98ISR Number: 3092183-3Report Type:Periodic Company Report #US97102356A Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa PS ORAL 5.00 MG PO Initial or Prolonged Pyrexia Health Bactrim C Professional Date:01/30/98ISR Number: 3092186-9Report Type:Periodic Company Report #US97102407A Age:89 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Pneumonia Aspiration Pulmonary Congestion 24-Jun-2005 12:19 PM Page: 195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Tachycardia Vomiting Report Source Product Role Manufacturer Route Dose Duration Study Zyprexa PS ORAL 5.00 MG DAILY Health PO Professional Zantac C Ativan C Demerol C Date:01/30/98ISR Number: 3092189-4Report Type:Periodic Company Report #US97103394A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Condition Aggravated Health PO Dehydration Professional Allegra C Hypernatraemia Synthroid C Pneumonia Lorazepam C Pulmonary Congestion Pyrexia Sepsis Date:01/30/98ISR Number: 3092193-6Report Type:Periodic Company Report #US97104534A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Health PO Professional Prolixin C Atarax C Date:01/30/98ISR Number: 3092195-XReport Type:Periodic Company Report #US97105395A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Flat Affect Study Zyprexa PS ORAL 20.00 MG Initial or Prolonged Hallucination, Auditory Health DAILY PO Insomnia Professional Lithobid C Mania Pressure Of Speech Date:01/30/98ISR Number: 3092209-7Report Type:Periodic Company Report #US97105779A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Hip Fracture Health PO Disability Professional Aspirin C Isoptin-Slow Release C Multivitamin C 24-Jun-2005 12:19 PM Page: 196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092210-3Report Type:Periodic Company Report #US97112344A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oral Intake Reduced Study Zyprexa PS ORAL 5.00 MG PO Respiratory Failure Health Professional Date:01/30/98ISR Number: 3092211-5Report Type:Periodic Company Report #US97112422A Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa PS ORAL 10.00 MG Life-Threatening Heart Rate Decreased Health DAILY PO Hypotension Professional Lorazepam C Oral Intake Reduced Buspirone C Levothyroxine Sodium C Digoxin C Trazodone C Tylenol C Bacitracin C Date:01/30/98ISR Number: 3092212-7Report Type:Periodic Company Report #US97112731A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clavicle Fracture Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Fall Health DAILY PO Professional Phazyme C Docusate C Nortriptyline C Lanoxin C Aspirin C Buspar C Hydroxyzine C Enulose C Vitamin E C Ibuprofen C Acetaminophen C Milk Of Magnesia C Zithromax C Cipro C Xanax C Date:01/30/98ISR Number: 3092213-9Report Type:Periodic Company Report #US97121015A Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Study Zyprexa PS ORAL 10.00 MG PO Hospitalization - Dehydration Health Aspirin C Initial or Prolonged Ecchymosis Professional Cyanocobalamin C Excoriation Propanolol C Fall Vicon Forte C Oral Intake Reduced Docusate Sodium C Urinary Tract Infection Zantac C Ativan C Vistaril C 24-Jun-2005 12:19 PM Page: 197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092214-0Report Type:Periodic Company Report #US97121063A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Study Zyprexa PS ORAL 10.00 MG Hospitalization - Abdominal Pain Upper Health DAILY PO Initial or Prolonged Pneumonia Professional Magnesium Citrate C Bisacodyl C Milk Of Magnesia C Demerol C Phenergan C Date:01/30/98ISR Number: 3092215-2Report Type:Periodic Company Report #US97122884A Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Infiltration Study Zyprexa PS ORAL 10.00 MG Hospitalization - Pneumonia Aspiration Health DAILY PO Initial or Prolonged Pyrexia Professional Ceftriaxone C Trihexyphenidyl C Diltiazem C Metronidazole C Date:01/30/98ISR Number: 3092216-4Report Type:Periodic Company Report #US97124444A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Study Zyprexa PS ORAL 20.00 MG Fatigue Health DAILY PO Hepatitis Professional Influenza Like Illness Lethargy Pain Pyrexia Date:01/30/98ISR Number: 3092217-6Report Type:Periodic Company Report #US97125038A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Zyprexa PS ORAL 10.00 MG PO Initial or Prolonged Health Professional Date:01/30/98ISR Number: 3092218-8Report Type:Periodic Company Report #US97125710A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Aggression Health DAILY PO Condition Aggravated Professional Grandiosity Insomnia Irritability Judgement Impaired Medication Error Pressure Of Speech 24-Jun-2005 12:19 PM Page: 198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092219-XReport Type:Periodic Company Report #US98010145A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Zyprexa PS ORAL 20.00 MG Initial or Prolonged Health DAILY PO Professional Prozac C Famotidine C Ultram C Valium C Motrin C Date:01/30/98ISR Number: 3092220-6Report Type:Periodic Company Report #US97082461A Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Paranoia Health DAILY PO Professional Date:01/30/98ISR Number: 3092221-8Report Type:Periodic Company Report #US97085023A Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Study Zyprexa PS ORAL 5.00 MG DAILY Other Coma Health PO Hypotension Professional Cipro C Mental Impairment Ferrous Sulfate C Prilosec C Peri-Colace C Albuterol C Alprazolam C Date:01/30/98ISR Number: 3092222-XReport Type:Periodic Company Report #US97092296A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Hallucination Health DAILY PO Professional Date:01/30/98ISR Number: 3092223-1Report Type:Periodic Company Report #US97092452A Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS ORAL 15.00 MG Initial or Prolonged Depression Health DAILY Hepatitis C Professional Valium C Prozac C Salsalate C Benazepril Hydrochloride C 24-Jun-2005 12:19 PM Page: 199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092224-3Report Type:Periodic Company Report #US97083151A Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Study Zyprexa PS ORAL 15.00 MG Infection Health DAILY Professional Date:01/30/98ISR Number: 3092225-5Report Type:Periodic Company Report #US97120121A Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pneumonia Health PO Tachycardia Professional Zantac C Heartburn C Date:01/30/98ISR Number: 3092441-2Report Type:Periodic Company Report #US97012404A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Lithium C Paroxetine C Insulin C Date:01/30/98ISR Number: 3092444-8Report Type:Periodic Company Report #US97031720A Age: Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Inappropriate Health Zyprexa PS Eli Lilly And Co Antidiuretic Hormone Professional Secretion Date:01/30/98ISR Number: 3092446-1Report Type:Periodic Company Report #US97040373A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Hypertension Professional DAILY PO Nervousness Entex La C Sedation Trimox C Speech Disorder Tremor Date:01/30/98ISR Number: 3092450-3Report Type:Periodic Company Report #US97051819A Age:34 YR Gender:Female I/FU:F Outcome PT Amblyopia Amnesia Anxiety Depression Dizziness Glaucoma Headache 24-Jun-2005 12:19 PM Page: 200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Nausea Sedation Report Source Product Role Manufacturer Route Dose Duration Tachycardia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Thinking Abnormal Health DAILY PO Tremor Professional Prednisone C Vomiting Other Asthma C Nasacort C Date:01/30/98ISR Number: 3092453-9Report Type:Periodic Company Report #US97052131A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3092455-2Report Type:Periodic Company Report #US97054228A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Eli Lilly And Co 10.00 MG Phosphokinase Increased Professional DAILY Weight Increased Depakote C ... C Multivitamin C Zantac C Clonidine C Date:01/30/98ISR Number: 3092458-8Report Type:Periodic Company Report #US97060937A Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Phosphokinase Increased Professional 2/DAY PO Weight Increased Haldol C Klonopin C Date:01/30/98ISR Number: 3092460-6Report Type:Periodic Company Report #US97061063A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Depakote C Date:01/30/98ISR Number: 3092463-1Report Type:Periodic Company Report #US97062269A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Health Zyprexa PS Eli Lilly And Co Professional Luvox C Company Wellbutrin C Representative 24-Jun-2005 12:19 PM Page: 201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092467-9Report Type:Periodic Company Report #US97063280A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Therapeutic Professional DAILY PO Lithium C Depakote C Mellaril C Date:01/30/98ISR Number: 3092471-0Report Type:Periodic Company Report #US97063289A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Leukopenia Professional PO Liver Function Test Klonopin C Abnormal Tegretol C Malaise Premarin C Date:01/30/98ISR Number: 3092476-XReport Type:Periodic Company Report #US97064045A Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO 4 DAY Prozac C Lorazepam C Date:01/30/98ISR Number: 3092479-5Report Type:Periodic Company Report #US97065155A Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Iritis Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3092483-7Report Type:Periodic Company Report #US97065410A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Insomnia Professional PO Oedema Company Effexor C Representative Date:01/30/98ISR Number: 3092487-4Report Type:Periodic Company Report #US97070484A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Pamelor C Trazodone C 24-Jun-2005 12:19 PM Page: 202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092490-4Report Type:Periodic Company Report #US97072005A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Haldol C Ativan C Diazepam C Apap C Maalox C Milk Of Magnesia C Date:01/30/98ISR Number: 3092493-XReport Type:Periodic Company Report #US97072020A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Increased Professional DAILY PO Vitamins C Date:01/30/98ISR Number: 3092496-5Report Type:Periodic Company Report #US97073277A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Blood Creatine Professional DAILY PO Phosphokinase Increased Prozac C Confusional State Cogentin C Coordination Abnormal Lorazepam C Dyskinesia Hyperhidrosis Hypertonia Intentional Misuse Muscle Rigidity Musculoskeletal Stiffness Pyrexia Tachycardia Tremor Date:01/30/98ISR Number: 3092499-0Report Type:Periodic Company Report #US97075173A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Choreoathetosis Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Delusion Professional DAILY PO Company Nifedipine C Representative Nicotine Dermal Patch C Date:01/30/98ISR Number: 3092503-XReport Type:Periodic Company Report #US97076211A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Facial Palsy Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Depakote C Risperdal C 24-Jun-2005 12:19 PM Page: 203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tranxene C Vistaril C Date:01/30/98ISR Number: 3092511-9Report Type:Periodic Company Report #US97082272A Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Eli Lilly And Co ORAL 7.50 MG DAILY Drug Interaction Professional PO Anafranil C Klonopin C Date:01/30/98ISR Number: 3092517-XReport Type:Periodic Company Report #US97082284A Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS Eli Lilly And Co Positive Professional Buspar C Arthritis Oedema Pain Date:01/30/98ISR Number: 3092520-XReport Type:Periodic Company Report #US97082446A Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Sedation Health DAILY PO Weight Increased Professional Date:01/30/98ISR Number: 3092526-0Report Type:Periodic Company Report #US97083877A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Eli Lilly And Co 5.00 MG 2 MON Professional Company Representative Date:01/30/98ISR Number: 3092534-XReport Type:Periodic Company Report #US97084228A Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Weight Increased Professional DAILY PO Date:01/30/98ISR Number: 3092549-1Report Type:Periodic Company Report #US97085029A Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Myalgia Health DAILY PO Tendon Disorder Professional Nadolol C Weight Increased Estrogen Nos C Medroxyprogesterone C 24-Jun-2005 12:19 PM Page: 204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trihexyphenidyl C Fluoxetine C Date:01/30/98ISR Number: 3092552-1Report Type:Periodic Company Report #US97085041A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Oedema Professional DAILY PO Papilloedema Propranol C Weight Increased Artane C Prozac C Ativan C Date:01/30/98ISR Number: 3092557-0Report Type:Periodic Company Report #US97085143A Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Abnormal Professional DAILY PO Metamucil C Date:01/30/98ISR Number: 3092561-2Report Type:Periodic Company Report #US97091078A Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Fluoxetine Hcl PS Lilly Research Professional Laboratories Div Eli Lilly And Co ORAL 20.00 MG DAILY PO Zyprexa SS ORAL 20.00 MG DAILY PO Valproic Acid C Date:01/30/98ISR Number: 3092562-4Report Type:Periodic Company Report #US97092086A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co 10.00 MG Prolonged Professional Oedema Company Representative Date:01/30/98ISR Number: 3092563-6Report Type:Periodic Company Report #US97092455A Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Phosphokinase Increased Professional DAILY PO Sertraline C Lasix C Librium C Insulin C Prevacid C Imdur C Synthroid C 24-Jun-2005 12:19 PM Page: 205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lisinopril C Date:01/30/98ISR Number: 3092566-1Report Type:Periodic Company Report #US97092869A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS Eli Lilly And Co ORAL 30.00 MG Intentional Misuse DAILY PO 3 MON Paxil C Klonopin C Date:01/30/98ISR Number: 3092569-7Report Type:Periodic Company Report #US97092917A Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Phosphatase Increased Professional DAILY PO Hyperbilirubinaemia Cogentin C Klonopin C Amantadine C Date:01/30/98ISR Number: 3092572-7Report Type:Periodic Company Report #US97092944A Age:40 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Faecal Incontinence Professional DAILY PO Urinary Incontinence Prozac SS ORAL 10.00 MG DAILY PO Lithium C Levothyroxine C Date:01/30/98ISR Number: 3092574-0Report Type:Periodic Company Report #US97092965A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Abnormal Professional DAILY PO Tegretol C Ativan C Stelazine C Date:01/30/98ISR Number: 3092575-2Report Type:Periodic Company Report #US97094258A Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa PS Eli Lilly And Co ORAL 12.50 MG Increased Professional DAILY PO Aspartate Zoloft C Aminotransferase Asa C Increased Haematemesis 24-Jun-2005 12:19 PM Page: 206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092577-6Report Type:Periodic Company Report #US97094726A Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Lorazepam C Lithium C Date:01/30/98ISR Number: 3092579-XReport Type:Periodic Company Report #US97094906A Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3092583-1Report Type:Periodic Company Report #US97095173A Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Below Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Therapeutic Professional DAILY PO Acetaminophen C Naprosyn C Klonopin C Entex La C Vancenase C Benadryl C Depakote C Triple Antibiotic Ointment C Date:01/30/98ISR Number: 3092590-9Report Type:Periodic Company Report #US97095413A Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3092591-0Report Type:Periodic Company Report #US97100181A Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Consumer Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY Increased PO Vasotec C Depakote C Date:01/30/98ISR Number: 3092592-2Report Type:Periodic Company Report #US97100514A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY PO 9 MON Lithium C 24-Jun-2005 12:19 PM Page: 207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092594-6Report Type:Periodic Company Report #US97100733A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS Eli Lilly And Co 2 MON Pallor Health Lithium C Professional Date:01/30/98ISR Number: 3092595-8Report Type:Periodic Company Report #US97100745A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO 4 DAY Company Trifalon C Representative Date:01/30/98ISR Number: 3092597-1Report Type:Periodic Company Report #US97100760A Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Health Zyprexa PS Eli Lilly And Co Hostility Professional Prolixin C Sedation Company Representative Date:01/30/98ISR Number: 3092599-5Report Type:Periodic Company Report #US97100763A Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Health Zyprexa PS Eli Lilly And Co ORAL 100.00 MG Professional DAILY PO Company Representative Date:01/30/98ISR Number: 3092602-2Report Type:Periodic Company Report #US97100919A Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY PO Zoloft C Date:01/30/98ISR Number: 3092606-XReport Type:Periodic Company Report #US97100967A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Consumer Zyprexa PS Eli Lilly And Co ORAL PO 3 MON Date:01/30/98ISR Number: 3092607-1Report Type:Periodic Company Report #US97100982A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa PS Eli Lilly And Co ORAL 25.00 MG Thrombocytopenia Professional DAILY PO 2 MON Paxil C 24-Jun-2005 12:19 PM Page: 208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Date:01/30/98ISR Number: 3092610-1Report Type:Periodic Company Report #US97100994A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laryngospasm Health Zyprexa PS Eli Lilly And Co SUBCUTANEOUS 20.00 MG Professional DAILY SC Cogentin C Ativan C Date:01/30/98ISR Number: 3092612-5Report Type:Periodic Company Report #US97101000A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Liver Function Test Professional DAILY PO Abnormal Anafranil C Vomiting Prozac C Date:01/30/98ISR Number: 3092614-9Report Type:Periodic Company Report #US97101012A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG 2/DAY Professional PO 2 MON Mellaril C Date:01/30/98ISR Number: 3092617-4Report Type:Periodic Company Report #US97101021A Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertonia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Muscle Twitching DAILY PO Date:01/30/98ISR Number: 3092620-4Report Type:Periodic Company Report #US97101048A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO 3 MON Humulin 70/30 C Cogentin C Ferrous Sulfate C Date:01/30/98ISR Number: 3092624-1Report Type:Periodic Company Report #US97101051A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co 20.00 MG Professional Company Representative 24-Jun-2005 12:19 PM Page: 209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092627-7Report Type:Periodic Company Report #US97101060A Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO 1 YR Company Prozac SS 40.00 MG Representative DAILY Remeron C Date:01/30/98ISR Number: 3092630-7Report Type:Periodic Company Report #US97021234A Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Health Zyprexa PS 150.00 MG Initial or Prolonged Overdose Professional Lithium C Other Sedation Depakote C Date:01/30/98ISR Number: 3092633-2Report Type:Periodic Company Report #US97035971A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS Tachycardia Professional Thinking Abnormal Date:01/30/98ISR Number: 3092638-1Report Type:Periodic Company Report #US97043925A Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Zyprexa PS ORAL 15.00 MG Initial or Prolonged Rectal Haemorrhage Professional DAILY Other Warfarin C Captopril C Digoxin C Insulin C Ranitidine C Docusate C Date:01/30/98ISR Number: 3092643-5Report Type:Periodic Company Report #US97062155A Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervous System Disorder Health Zyprexa PS 90.00 TA Overdose Professional Date:01/30/98ISR Number: 3092646-0Report Type:Periodic Company Report #US97064069A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 10.00 MG 2 MON Initial or Prolonged Hyponatraemia Professional Serzone C Polydipsia Company Upper Gastrointestinal Representative Haemorrhage 24-Jun-2005 12:19 PM Page: 210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092649-6Report Type:Periodic Company Report #US97071180A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS SCHIZOPHRENIA Syndrome Professional Company Representative Date:01/30/98ISR Number: 3092652-6Report Type:Periodic Company Report #US97072998A Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Zyprexa PS ORAL 20.00 MG Professional DAILY 9 MON Depakote C Date:01/30/98ISR Number: 3092654-XReport Type:Periodic Company Report #US97074297A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Zyprexa PS ORAL 15.00 MG Professional DAILY Risperidone C Valproate Sodium C Date:01/30/98ISR Number: 3092656-3Report Type:Periodic Company Report #US97074306A Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Bipolar I Disorder Professional DAILY Coma Other Clonazepam C Delirium Albuterol C Diabetes Mellitus Metformin C Non-Insulin-Dependent Vasotec C Hypercholesterolaemia Lasix C Hypertension Tegretol C Hyponatraemia Iron C Miosis Multivitamins C Mitral Valve Disease Aspirin C Pulmonary Valve Disease Glipizide C Sedation Nitroglycerin C Date:01/30/98ISR Number: 3092658-7Report Type:Periodic Company Report #US97076259A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS ORAL 30.00 MG Intentional Misuse Professional DAILY Medication Error Paxil C Loxitane C Dilantin C Remeron C Tegretol C 24-Jun-2005 12:19 PM Page: 211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092660-5Report Type:Periodic Company Report #US97080403A Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Intervention to Blood Creatine Professional DAILY PO Prevent Permanent Phosphokinase Increased Company Tamoxifen C Impairment/Damage Dysphagia Representative Motrin C Hepatic Function Abnormal Oscal C Hypertonia Cogentin C Hyperventilation Symmetrel C Leukocytosis Tegretol C Neuroleptic Malignant Sinemet C Syndrome Pyrexia Tachycardia Tremor Date:01/30/98ISR Number: 3092662-9Report Type:Periodic Company Report #US97082449A Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Malignant Health Zyprexa PS ORAL 12.50 MG Initial or Prolonged Professional DAILY Cardizem C Lasix C Sinemet C Eldepryl C Parlodel C Ditropan C Date:01/30/98ISR Number: 3092665-4Report Type:Periodic Company Report #US97090457A Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Zyprexa PS 5.00 Initial or Prolonged Parkinsonism Professional Clozaril C L-Dopa C Date:01/30/98ISR Number: 3092667-8Report Type:Periodic Company Report #US97090832A Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 2.50 MG Initial or Prolonged Confusional State Professional Paranoia Sedation Date:01/30/98ISR Number: 3092669-1Report Type:Periodic Company Report #US97091084A Age:70 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Condition Aggravated Confusional State Joint Stiffness Mental Disorder 24-Jun-2005 12:19 PM Page: 212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Sedation White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Health Zyprexa PS 10.00 MG Professional DAILY Company Haldol C Representative Vasotec C Date:01/30/98ISR Number: 3092670-8Report Type:Periodic Company Report #US97092005A Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Zyprexa PS ORAL 30.00 MG Health DAILY 5 WK Professional Tegretol C Lithium C Date:01/30/98ISR Number: 3092672-1Report Type:Periodic Company Report #US97093190A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Vaginal Haemorrhage Health Klonopin C Professional Date:01/30/98ISR Number: 3092673-3Report Type:Periodic Company Report #US97094222A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Diabetes Mellitus Professional DAILY Inadequate Control Synthroid C Diabetic Ketoacidosis Haloperidol C Mental Disorder Date:01/30/98ISR Number: 3092675-7Report Type:Periodic Company Report #US97095449A Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS 150.00 MG Sedation Professional Venlafaxine C Tachycardia Date:01/30/98ISR Number: 3092676-9Report Type:Periodic Company Report #US97101144A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Health Zyprexa PS Eli Lilly And Co Professional Company Representative 24-Jun-2005 12:19 PM Page: 213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092677-0Report Type:Periodic Company Report #US97101162A Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glycosuria Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG 3/DAY Hyperglycaemia Professional PO Urinary Incontinence Paxil C Weight Increased Depakote C Ortho-Novum 1/35 C Multivitamin C Date:01/30/98ISR Number: 3092679-4Report Type:Periodic Company Report #US97101186A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS Eli Lilly And Co 20.00 MG Date:01/30/98ISR Number: 3092682-4Report Type:Periodic Company Report #US97101201A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Abnormal Professional DIALY PO Depakote C Date:01/30/98ISR Number: 3092683-6Report Type:Periodic Company Report #US97101219A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Sedation PO Klonopin C Risperdal C Tegretol C Depakote C Date:01/30/98ISR Number: 3168514-2Report Type:Expedited (15-DaCompany Report #US97113817A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS Syndrome Professional Company Representative Date:02/02/98ISR Number: 3022695-XReport Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Death Cardiac Arrest Cardiomegaly Coma Mental Impairment Neuroleptic Malignant Syndrome Pulmonary Embolism Pulmonary Infarction 24-Jun-2005 12:19 PM Page: 214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Respiratory Rate Increased Report Source Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 15MG PO QHS Paxil SS 20MG QHS Desyrel SS 100MG QHS Date:02/04/98ISR Number: 3024239-5Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Olanzapine PS ORAL 2.5 MG PO X 3 DOSES Imipenem SS INTRAVENOUS 500 MG IV Q 6 HOURS Famotidine C Metronidazole C Diphenhydramine C Hydrocortisone C Estrogen C Ibuprophen C Hydromorphone C Acyclovir C Date:02/04/98ISR Number: 3027259-XReport Type:Direct Company Report # Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Sensation Zeprexa PS ORAL 5 MG ORAL 3 MON Condition Aggravated Lithium C Dysphagia Oesophageal Disorder Panic Attack Paraesthesia Date:02/06/98ISR Number: 3025914-9Report Type:Expedited (15-DaCompany Report #US97104963A Age:6 WK Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS 28 WK Complications Of Maternal Professional Exposure To Therapeutic Drugs Congenital Mitral Valve Incompetence Sudden Infant Death Syndrome Date:02/06/98ISR Number: 3025917-4Report Type:Expedited (15-DaCompany Report #GB98013316A Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Torsade De Pointes Health DAILY PO Ventricular Tachycardia Professional Periciazine C Lithium Carbonate C Frusemide C 24-Jun-2005 12:19 PM Page: 215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C Glyceryl Trinitrate C Thyroxin C Lorazepam C Sertraline C Peppermint Oil C Loperamide C Carbamazepine C Valproate Sodium C Procyclidine C Date:02/06/98ISR Number: 3025919-8Report Type:Expedited (15-DaCompany Report #DE98012434A Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Zyprexa PS ORAL 10.00 MG PO 9 MON Hospitalization - Condition Aggravated Health Initial or Prolonged Grand Mal Convulsion Professional Pulmonary Oedema Respiratory Distress Sedation Status Epilepticus Date:02/06/98ISR Number: 3025922-8Report Type:Expedited (15-DaCompany Report #CA97112086A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Foreign Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Anaemia Vitamin B12 Health PO Other Deficiency Professional Valproic Acid C Drug Interaction Cogentin C Folate Deficiency Tazocin C Haemoglobin Decreased Mean Cell Volume Increased Neutrophil Count Decreased Pancytopenia Platelet Count Decreased Pyrexia White Blood Cell Count Decreased Date:02/06/98ISR Number: 3025924-1Report Type:Expedited (15-DaCompany Report #GB97050760A Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS ORAL 60.00 MG PO Hospitalization - Loss Of Consciousness Health Procyclidine C Initial or Prolonged Overdose Professional Ethanol C Other Respiratory Depression Other 24-Jun-2005 12:19 PM Page: 216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/98ISR Number: 3025928-9Report Type:Expedited (15-DaCompany Report #DE98013577A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 15.00 MG PO Condition Aggravated Literature Hallucination Health Professional Date:02/06/98ISR Number: 3025931-9Report Type:Expedited (15-DaCompany Report #US98010592A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Zyprexa PS ORAL 30.00 MG Mania Health DAILY PO Tardive Dyskinesia Professional Mellaril C Thinking Abnormal Desipramine C Date:02/06/98ISR Number: 3026491-9Report Type:Expedited (15-DaCompany Report #GB98014492A Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mass Foreign Zyprexa PS ORAL 10.00MG DAILY Oedema Peripheral Health PO Professional Procyclidine C Other Lithium C Carbamazepine C Thyroxin C Erythromycin C Co-Danthramer C Date:02/06/98ISR Number: 3026492-0Report Type:Expedited (15-DaCompany Report #GB98010637A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholangitis Sclerosing Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Condition Aggravated Health DAILY PO Other Liver Disorder Professional Ursodeoxycholic Acid C Liver Function Test Hydroxyzine Abnormal Hydrochloride C White Blood Cell Count Decreased Date:02/06/98ISR Number: 3026493-2Report Type:Expedited (15-DaCompany Report #ES98014942A Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS ORAL 10.00MG DAILY Health PO Professional Etumina C Haloperidol C Lorazepam C 24-Jun-2005 12:19 PM Page: 217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/98ISR Number: 3026494-4Report Type:Expedited (15-DaCompany Report #US98014615A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS ORAL 5.00 MG DAILY Other Overdose Professional PO Other Erythrocin C Zovirax C Trazodone C Depakote C Date:02/06/98ISR Number: 3026495-6Report Type:Expedited (15-DaCompany Report #US98015323A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS ORAL 20 MG DAILY Professional PO Company Risperdal C Representative Vistaril C Benardyl C Depakote C Date:02/06/98ISR Number: 3026496-8Report Type:Expedited (15-DaCompany Report #DE98014486A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS ORAL 10.00MG PO Initial or Prolonged Health Professional Other Date:02/06/98ISR Number: 3026501-9Report Type:Expedited (15-DaCompany Report #FR98015077A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa PS ORAL 10.00 MG Drug Level Above Health DAILY PO Therapeutic Professional Anafranil C Daonil C Tercian C Date:02/06/98ISR Number: 3026502-0Report Type:Expedited (15-DaCompany Report #US98014513A Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Literature Zyprexa PS Initial or Prolonged Cyanosis Health Luvox C Other Overdose Professional Respiratory Depression Date:02/06/98ISR Number: 3026503-2Report Type:Expedited (15-DaCompany Report #US98014522A Age:28 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Heart Rate Increased Other Overdose 24-Jun-2005 12:19 PM Page: 218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Literature Zyprexa PS ORAL 25.00 MG UNK Health PO Professional Synthroid C Date:02/06/98ISR Number: 3026506-8Report Type:Expedited (15-DaCompany Report #US97045965A Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Literature Zyprexa PS ORAL 100 MG 1 PO Initial or Prolonged Intentional Misuse Health Heroin C Other Lethargy Professional Miosis Suicide Attempt Date:02/12/98ISR Number: 3029275-0Report Type:Direct Company Report # Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fluid Retention Health Zyprexa PS UP TO 25 Initial or Prolonged Professional MG/DAY Disability Other Required Intervention to Prevent Permanent Impairment/Damage Date:02/12/98ISR Number: 3029281-6Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Olanzapine PS ORAL 35 MG HS PO Date:02/13/98ISR Number: 3029856-4Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akathisia Zyprexa PS Lilly ORAL 5 MG ORAL Hospitalization - Atrial Fibrillation DAILY Initial or Prolonged Atrial Tachycardia Coumadin C Required Muscle Rigidity Lanoxin C Intervention to Neuroleptic Malignant Calan Sr C Prevent Permanent Syndrome Valium C Impairment/Damage Pyrexia Date:02/17/98ISR Number: 3030488-2Report Type:Expedited (15-DaCompany Report #7394931 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Depakote PS Abbott ORAL 500.00 MG PO Initial or Prolonged Rhabdomyolysis Professional BID Zyprexa SS 24-Jun-2005 12:19 PM Page: 219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/98ISR Number: 3030581-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Olanzapine PS 5MG DAILY Extrapyramidal Disorder Paoxetine C Muscle Spasms Propranolol C Musculoskeletal Stiffness Furosemide C Diazapam C Piroxicam C Date:02/17/98ISR Number: 3030674-1Report Type:Expedited (15-DaCompany Report #NZ98021504A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Zyprexa PS ORAL 30.00 MG Psychotic Disorder Health DAILY PO 3 MON Professional Date:02/17/98ISR Number: 3031168-XReport Type:Expedited (15-DaCompany Report #US97103742A Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Zyprexa PS ORAL 25.00 MG Professional DAILY PO Company Haldol C Representative Lithium C Propranolol C Amantadine C Ativan C Date:02/17/98ISR Number: 3031185-XReport Type:Expedited (15-DaCompany Report #US97106181A Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Confusional State Health DAILY PO Other Deafness Professional Depakote C Diabetes Mellitus Hepatomegaly Insomnia Pancreatic Disorder Pollakiuria Renal Hypertrophy Weight Decreased Date:02/17/98ISR Number: 3031190-3Report Type:Expedited (15-DaCompany Report #BBB999 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa PS ORAL 10.00 MG Hepatic Function Abnormal Company DAILY PO Loss Of Consciousness Representative Risperdal C ORAL 1.00 MG DAILY Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/98ISR Number: 3031198-8Report Type:Expedited (15-DaCompany Report #IE97124525A Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS ORAL 10.00 MG UNK Health PO Professional Atenolol C Orphenadrine Hydrochloride C Diazepam C Flurazepam C Chlorpromazine C Haloperidol C Date:02/17/98ISR Number: 3031201-5Report Type:Expedited (15-DaCompany Report #SE98013496A Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Foreign Zyprexa PS Other Date:02/17/98ISR Number: 3031206-4Report Type:Expedited (15-DaCompany Report #CL97075797A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Hyperglycaemia Consumer DIALY PO Hyperphagia Health Prozac C Hypersomnia Professional Mania Company Weight Increased Representative Date:02/17/98ISR Number: 3031213-1Report Type:Expedited (15-DaCompany Report #ES98014942A Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Etumina C ORAL 40.00 MG DAILY PO Haloperidol C Lorazepam C ORAL 5.00 MG 1/D PO Date:02/17/98ISR Number: 3031424-5Report Type:Expedited (15-DaCompany Report #AU98020364A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa PS ORAL PO Other Health Doxycycline C Professional Panadeine Forte C 24-Jun-2005 12:19 PM Page: 221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/98ISR Number: 3031427-0Report Type:Expedited (15-DaCompany Report #US98020670A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Professional Company Representative Date:02/17/98ISR Number: 3031429-4Report Type:Expedited (15-DaCompany Report #US98020436A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Zyprexa PS ORAL 10.00MG 2/DAY Professional PO Prilosec C Ferrous Sulphate C ORAL Date:02/17/98ISR Number: 3032671-9Report Type:Expedited (15-DaCompany Report #IL98021159A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dermatitis Foreign Zyprexa PS ORAL 10.00 MG Hospitalization - Heart Rate Irregular Health 2/DAY PO Initial or Prolonged Pneumonia Professional Carbamazepine C Pyrexia Valium C Respiratory Disorder Date:02/17/98ISR Number: 3032672-0Report Type:Expedited (15-DaCompany Report #GB98020967A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Zyprexa PS 5.00 MG DAILY Decreased Health Atenolol C Professional Date:02/17/98ISR Number: 3032673-2Report Type:Expedited (15-DaCompany Report #CA98020637A Age:51 YR Gender:Male I/FU:I Outcome PT Agitation Blood Creatine Phosphokinase Increased Confusional State Delirium Dysphagia Extrapyramidal Disorder Hyperhidrosis Leukocytosis Muscle Rigidity Mutism Neuroleptic Malignant Syndrome Repetitive Speech Respiratory Rate Increased Salivary Hypersecretion Tachycardia 24-Jun-2005 12:19 PM Page: 222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Trismus Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS ORAL 20 MG DAILY Health PO Professional Benzodiazepine C Company Representative Date:02/19/98ISR Number: 3032445-9Report Type:Expedited (15-DaCompany Report #JAFIN-37709 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Foreign Risperdal PS ORAL 2 MG DAILY Initial or Prolonged Decreased Study ORAL Health Olanzapine SS ORAL 2 MG DAILY Professional ORAL Date:02/19/98ISR Number: 3037374-2Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Zyprexa PS ORAL 40 MG PO QDAY 2 MON Initial or Prolonged Liver Function Test Dilantin C Abnormal Prozac C Nausea Furosemide C Supraventricular Tachycardia Vomiting Date:02/20/98ISR Number: 3032534-9Report Type:Expedited (15-DaCompany Report #US98022425A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Hallucination, Auditory Professional DAILY PO Zoloft C Date:02/20/98ISR Number: 3032538-6Report Type:Expedited (15-DaCompany Report #US98022149A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS Initial or Prolonged Coma Professional Other Intentional Misuse Company Representative Date:02/20/98ISR Number: 3032541-6Report Type:Expedited (15-DaCompany Report #US98022107A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Zyprexa PS Acetaminophen C Propoxyphene C Valproic Acid C Clonazepam C 24-Jun-2005 12:19 PM Page: 223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluvoxamine C Remeron C Date:02/20/98ISR Number: 3032543-XReport Type:Expedited (15-DaCompany Report #US98022119A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS Professional Date:02/20/98ISR Number: 3032545-3Report Type:Expedited (15-DaCompany Report #GB98022263A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS 10.00 MG Phosphokinase Increased Health Lofepramine C Cardio-Respiratory Arrest Professional Catatonia Company Extrapyramidal Disorder Representative Hypotension Myocardial Infarction Myocarditis Neuroleptic Malignant Syndrome Pyrexia Respiratory Rate Increased Date:02/20/98ISR Number: 3032548-9Report Type:Expedited (15-DaCompany Report #US98021828A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Blood Amylase Increased Health PO Other Pancreatitis Professional Zydone C Tenormin C 50 MG Drixoral C Date:02/20/98ISR Number: 3032551-9Report Type:Expedited (15-DaCompany Report #DE98022914A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa PS ORAL 5.00 MG Initial or Prolonged Dermatitis Health Leukopenia Professional Neutropenia Pyrexia Date:02/20/98ISR Number: 3034667-XReport Type:Expedited (15-DaCompany Report #DE9802261A Age:61 YR Gender:Female I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Drug Interaction Extrapyramidal Disorder Fall 24-Jun-2005 12:19 PM Page: 224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS ORAL 20.00 MG; PO Health Valproate Sodium C Professional Trevilor C Clonazepam C Atenolol C Date:02/20/98ISR Number: 3034670-XReport Type:Expedited (15-DaCompany Report #US98021939A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO Chills Other Depakote C Chromaturia Fatigue Feeling Jittery Myalgia Oedema Peripheral Rhabdomyolysis Date:02/20/98ISR Number: 3034673-5Report Type:Expedited (15-DaCompany Report #AU98014624A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa PS ORAL 20 Initial or Prolonged Health MG/DAILY/PO Professional Clonazepam C Date:02/20/98ISR Number: 3034676-0Report Type:Expedited (15-DaCompany Report #US98021774A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Orbital Health Zyprexa PS ORAL 25 Condition Aggravated Professional MG/DAILY/PO Depakote C Lithium C Date:02/20/98ISR Number: 3034680-2Report Type:Expedited (15-DaCompany Report #US98022686A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Paxil C Valproic Acid C Clozapine C Date:02/23/98ISR Number: 3036275-3Report Type:Expedited (15-DaCompany Report #GB98012056A Age:72 YR Gender:Male I/FU:F Outcome PT Death Aortic Valve Stenosis Arrhythmia Chest Crushing 24-Jun-2005 12:19 PM Page: 225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Dementia Fall Report Source Product Role Manufacturer Route Dose Duration Hallucination Foreign Zyprexa PS 5.00 MG DAILY Lung Injury Health Co-Careldopa C Rib Fracture Professional Company Representative Date:02/23/98ISR Number: 3036279-0Report Type:Expedited (15-DaCompany Report #US97105236A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Zyprexa PS Chest Pain Zolpidem C Coronary Artery Disease Lorazepam C Dyspnoea Thioridazine C Electrocardiogram Abnormal Feeling Cold Malaise Precerebral Artery Occlusion Date:02/23/98ISR Number: 3036286-8Report Type:Expedited (15-DaCompany Report #NZ98021514A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS ORAL 30.00 MG Drug Ineffective Health DAILY PO 3 MON Psychotic Disorder Professional Haloperidol C Benztropine C Ranitidine C Clonazepam C Date:02/23/98ISR Number: 3036288-1Report Type:Expedited (15-DaCompany Report #US97080505A Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa PS ORAL 500.00 MG Amnesia Professional 1/PO 1 DAY Atrial Tachycardia Lorcet C Clonic Convulsion Pepcid C Dysarthria Prozac C Grand Mal Convulsion Xanax C Hypophosphataemia Mevacor C Muscle Twitching Sedation Sinus Tachycardia Supraventricular Tachycardia Tardive Dyskinesia Tremor 24-Jun-2005 12:19 PM Page: 226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/98ISR Number: 3036293-5Report Type:Expedited (15-DaCompany Report #US98020646A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Health Zyprexa PS Sepsis Professional Company Representative Date:02/23/98ISR Number: 3036294-7Report Type:Expedited (15-DaCompany Report #US97114621A Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lack Of Spontaneous Health Zyprexa PS ORAL 5.0 MG DAILY Hospitalization - Speech Professional PO 3 DAY Initial or Prolonged Neuroleptic Malignant Prolixin C Syndrome Ativan C Psychotic Disorder Cogentin C Pyrexia Tylenol C Tachycardia Date:02/23/98ISR Number: 3036297-2Report Type:Expedited (15-DaCompany Report #IE97124525A Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa PS ORAL 10.00 MG PO Myocardial Ischaemia Health Atenolol C Professional Diazepam C Flurazepam C Chlorpromazine C Haloperidol C Date:02/23/98ISR Number: 3036702-1Report Type:Direct Company Report # Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Zyprexa PS 0.10 MG BID Initial or Prolonged Blood Pressure Increased Navane SS 2 MG BID Required Confusional State Loxitane SS Intervention to Delusion Ativan SS 0.5 MG PO BID Prevent Permanent Drooling :2 MG Q HS Impairment/Damage Dysarthria Depokate SS 500MG BID; Gait Disturbance 750 MG HS Joint Stiffness Clonidine C 0.1 MG PO BID Muscle Rigidity Procardia Xl C 60 MG QD Oedema Peripheral Cogentin C 1 MG PO BID Sedation Date:02/23/98ISR Number: 3036869-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Health Olanzapine PS ORAL 10 MG Q AM, Intervention to Professional 5MG Q HS Prevent Permanent Haldol C Impairment/Damage Bisacodyl C Lorazepam C 24-Jun-2005 12:19 PM Page: 227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/98ISR Number: 3083026-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anger Zyprexa PS 2.5MG QD Q HS Confusional State Constipation Depression Dyskinesia Erectile Dysfunction Irritability Nausea Oral Discomfort Sedation Urinary Incontinence Date:02/26/98ISR Number: 3039793-7Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Zyprexa PS ORAL 7.5 MG PO QHS Congestive Risperidol SS Depressed Level Of Consciousness Leukocytosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Pyrexia Respiratory Failure Sepsis Tremor Date:02/27/98ISR Number: 3037683-7Report Type:Expedited (15-DaCompany Report #DE98022377A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa PS ORAL 5.00 MG,PO Initial or Prolonged Chest X-Ray Abnormal Health Dysphagia Professional Enanthema Leukopenia Lymphadenopathy Nausea Neutropenia Pyrexia Rash Erythematous Viral Infection Vomiting Date:02/27/98ISR Number: 3037684-9Report Type:Expedited (15-DaCompany Report #DE98024252A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS ORAL 20.00 MG Life-Threatening Respiratory Arrest Health DAILY PO Professional Carbamazepine C Lorazepam C 24-Jun-2005 12:19 PM Page: 228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haloperidol C Acetylsalicylic Acid C Isosorbide C Dytide H C Date:02/27/98ISR Number: 3037691-6Report Type:Expedited (15-DaCompany Report #CA98024381A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Foreign Zyprexa PS ORAL 1100.00 MG Initial or Prolonged Overdose Health DAILY PO Other Sedation Professional Sinus Tachycardia Date:02/27/98ISR Number: 3037692-8Report Type:Expedited (15-DaCompany Report #US98024168A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Initial or Prolonged Insulin-Dependent Professional Azithromycin C Disability Pancreatitis Haemorrhagic Date:02/27/98ISR Number: 3037782-XReport Type:Expedited (15-DaCompany Report #US97105689A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Health Zyprexa PS UNK Professional Droperidol C Depakote C Date:02/27/98ISR Number: 3037784-3Report Type:Expedited (15-DaCompany Report #DE98022641A Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS ORAL 20 MG, PO Initial or Prolonged Drug Interaction Health Valproate Sodium C Extrapyramidal Disorder Professional Trevilor C Fall Clonazepam C Immobile Atenolol C Date:02/27/98ISR Number: 3037787-9Report Type:Expedited (15-DaCompany Report #CA97062959A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Hyperphagia Health DAILY PO Lethargy Professional Pain In Extremity Skin Discolouration Sleep Disorder Weight Increased 24-Jun-2005 12:19 PM Page: 229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/98ISR Number: 3037788-0Report Type:Expedited (15-DaCompany Report #DE97103910A Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Zyprexa PS ORAL 10 MG, DAILY, Hospitalization - Cardiomyopathy Health PO Initial or Prolonged Condition Aggravated Professional Paroxetine C Saroten C Tavor C Hypnorex C Date:02/27/98ISR Number: 3037790-9Report Type:Expedited (15-DaCompany Report #DE98012434A Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Zyprexa PS ORAL 15.00 MG Hospitalization - Phosphokinase Increased Health DAILY PO Initial or Prolonged Brain Oedema Professional Grand Mal Convulsion Pulmonary Oedema Respiratory Distress Rhabdomyolysis Sedation Status Epilepticus Date:02/27/98ISR Number: 3038537-2Report Type:Expedited (15-DaCompany Report #IL98021159A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Lactate Foreign Zyprexa PS ORAL 10.00 MG Hospitalization - Dehydrogenase Increased Health 2/DAY PO Initial or Prolonged Clostridium Colitis Professional Carbamazepine C Dermatitis Haldol C 5 MG 2/D PO Dermatitis Exfoliative Valium C 5MG 2/D Diarrhoea Quinidine C 400 MG 2/D Dyspnoea Clonazepam C 1.00 MG 2/D Eosinophilia Eyelid Oedema Heart Rate Irregular Hepatic Enzyme Increased Hypersensitivity Liver Function Test Abnormal Lymphadenopathy Pneumonia Pruritus Pyrexia Respiratory Disorder Rhonchi Urticaria Date:02/27/98ISR Number: 3038538-4Report Type:Expedited (15-DaCompany Report #US97011660A Age:16 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Other Required 24-Jun-2005 12:19 PM Page: 230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 10.00 MG Abdominal Rigidity Professional DAILY PO Abdominal Tenderness Depakene C 625.00 MG Acute Abdomen 2/DAY Blood Creatinine Lorazepam C Increased Haloperidol C Dyspnoea Tigan C Hallucination, Auditory Ileus Paralytic Liver Function Test Abnormal Nausea Pancreatitis Urinary Incontinence Vomiting Date:02/27/98ISR Number: 3038539-6Report Type:Expedited (15-DaCompany Report #US98024165A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Health Zyprexa PS Influenza Like Illness Professional Depakote C Ketoacidosis Pancreatitis Haemorrhagic Pyrexia Date:02/27/98ISR Number: 3038540-2Report Type:Expedited (15-DaCompany Report #US98023373A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 660.00 MG Initial or Prolonged Overdose Professional Other Company Representative Date:02/27/98ISR Number: 3041940-8Report Type:Direct Company Report # Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Olanzapine PS Lilly 10MG PO HS Initial or Prolonged Face Oedema Fall Hypotension Lethargy Parkinsonian Gait Date:03/02/98ISR Number: 3039648-8Report Type:Expedited (15-DaCompany Report #JAFIN-37709 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Foreign Risperdal PS Janssen ORAL 2 MG DAILY Initial or Prolonged Decreased Study ORAL Health Olanzapine SS ORAL 2 MG DAILY Professional ORAL 24-Jun-2005 12:19 PM Page: 231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flixonase C Duact C Tenox C Date:03/02/98ISR Number: 3132890-7Report Type:Periodic Company Report #9700394 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Zoloft PS ORAL 25.00 MG Professional TOTAL:DAILY:O Company RAL Representative Olanzapine SS Ambien SS Date:03/02/98ISR Number: 3133724-7Report Type:Periodic Company Report #US97073961A Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Prozac PS ORAL 10.00 MG Initial or Prolonged Pyrexia Health DAILY PO Professional Zyprexa SS ORAL 5.00 MG DAILY PO Tylenol C Fever C Lithium C Inderal C Fosamax C Calcium Carbonate C Date:03/02/98ISR Number: 3138793-6Report Type:Periodic Company Report #9713883 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zoloft PS ORAL 25.00 MG Hallucination Professional TOTAL DAILY Hypertension ORAL Tachycardia Zyprexa SS ORAL ORAL Date:03/02/98ISR Number: 3140708-1Report Type:Periodic Company Report #9726391 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Zoloft Tablets PS ORAL 150 MG TOTAL Drug Interaction Professional DAILY ORAL Olanzapine SS ORAL ORAL Trazodone SS ORAL ORAL Pseudoephedrine SS ORAL ORAL Simvastatin C Date:03/02/98ISR Number: 3144454-XReport Type:Periodic Company Report #9726104 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Zoloft PS ORAL 50.00 MG TOTAL: DAILY: ORAL 24-Jun-2005 12:19 PM Page: 232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa SS ORAL ORAL Date:03/03/98ISR Number: 3049935-5Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly 30 MG HS Required Drooling Professional Lorazepam C Intervention to Hyperhidrosis Prevent Permanent Renal Impairment Impairment/Damage Sedation Tremor Date:03/03/98ISR Number: 3049936-7Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Health Zyprexa PS Eli Lilly ORAL 5 MG PO HS Initial or Prolonged Depressed Level Of Professional Other Consciousness Required Dyskinesia Intervention to Psychomotor Seizures Prevent Permanent Restlessness Impairment/Damage Tremor Date:03/03/98ISR Number: 3049938-0Report Type:Direct Company Report # Age:50 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Zyprexa PS Eli Lilly 20 MG HS Required Restlessness Professional Benadryl C Intervention to Depakote C Prevent Permanent Impairment/Damage Date:03/03/98ISR Number: 3049940-9Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Zyprexa PS Eli Lilly ORAL 20 MG Q 6 PM Required Drooling Professional PO Intervention to Restlessness Other Lithium C Prevent Permanent Sleep Disorder Impairment/Damage Tremor Date:03/05/98ISR Number: 3044413-1Report Type:Expedited (15-DaCompany Report #US98025638A Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS ORAL 1.25 MG DAILY 1 MON Initial or Prolonged Sinus Tachycardia Professional Other 24-Jun-2005 12:19 PM Page: 233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/98ISR Number: 3044415-5Report Type:Expedited (15-DaCompany Report #US98025638A Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS ORAL 1.25 MG DAILY 1 MON Initial or Prolonged Sinus Tachycardia Professional Other Date:03/05/98ISR Number: 3044416-7Report Type:Expedited (15-DaCompany Report #US98024666A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa PS ORAL 30.00 MG Initial or Prolonged Professional Company Representative Date:03/05/98ISR Number: 3044417-9Report Type:Expedited (15-DaCompany Report #DE98014966A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Leukopenia Health DAILY Professional Carbamazepine C ORAL 600 MG DAILY Psychosis C Date:03/05/98ISR Number: 3044421-0Report Type:Expedited (15-DaCompany Report #DE98024987A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS ORAL 25.00 MG PO Initial or Prolonged Aminotransferase Health Neurocil C Increased Professional Taxilan C Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Blood Lactate Dehydrogenase Increased Pneumonia Pyrexia Date:03/05/98ISR Number: 3044424-6Report Type:Expedited (15-DaCompany Report #IL98024495A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 15.00 MG Health DAILY PO Professional Date:03/05/98ISR Number: 3044428-3Report Type:Expedited (15-DaCompany Report #HU98024723A Age:28 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Foreign Zyprexa PS Syndrome Health Suicide Attempt Professional Company Representative Date:03/05/98ISR Number: 3044431-3Report Type:Expedited (15-DaCompany Report #GB98025236A Age:70 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa PS Syndrome Health Professional Company Representative Date:03/05/98ISR Number: 3044965-1Report Type:Expedited (15-DaCompany Report #DE97025314A Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged C-Reactive Protein Health DAILY PO Increased Professional Nifedipine C Delirium Phenprocoumon C Hepatic Steatosis Melperone C Parkinson'S Disease Pyrexia Date:03/05/98ISR Number: 3044967-5Report Type:Expedited (15-DaCompany Report #GB98024951A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crohn'S Disease Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Inflammatory Bowel Health DAILY PO Disease Professional Flupentixol C Other Trifluoperazine C Benztropine C Thioridazine C Date:03/05/98ISR Number: 3044970-5Report Type:Expedited (15-DaCompany Report #GB98022263A Age:44 YR Gender:Male I/FU:F Outcome PT Death Blood Creatine Phosphokinase Increased Body Temperature Increased Cardio-Respiratory Arrest Catatonia Hypotension Myocardial Infarction Myocarditis Neuroleptic Malignant Syndrome 24-Jun-2005 12:19 PM Page: 235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Arrest Respiratory Rate Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS ORAL 10.00 MG UNK Health PO Professional Lofepramine C Company Representative Date:03/05/98ISR Number: 3044978-XReport Type:Expedited (15-DaCompany Report #DE98022377A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa PS ORAL 5.00 MG UNK Initial or Prolonged Dermatitis Health PO Dysphagia Professional Leukopenia Lymphadenopathy Nausea Neutropenia Pyrexia Rash Erythematous Viral Infection Vomiting Date:03/05/98ISR Number: 3044983-3Report Type:Expedited (15-DaCompany Report #DE98022914A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa PS ORAL 5.00 MG UNK Initial or Prolonged Dermatitis Health PO Leukopenia Professional Neutropenia Pyrexia Date:03/05/98ISR Number: 3044987-0Report Type:Expedited (15-DaCompany Report #DE98024252A Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa PS ORAL 20.00 MG Life-Threatening Health DAILY PO Professional Carbamazepine C Lorazepam C Haloperidol C Acetylsalicylic C Isosorbide C Dytide H C Date:03/05/98ISR Number: 3044990-0Report Type:Expedited (15-DaCompany Report #ES97120940A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 20.00 MG Health DAILY PO 1 MON Professional Company Representative 24-Jun-2005 12:19 PM Page: 236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/98ISR Number: 3044992-4Report Type:Expedited (15-DaCompany Report #US97102194A Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Professional PO Doxazosin C Gabapentin C Perphenazine C Temazepam C Lorazepam C Triazolam C Lansoprazole C Acetaminophen C Antacid C Milk Of Magnesia C Date:03/05/98ISR Number: 3047436-1Report Type:Expedited (15-DaCompany Report #DE97054750A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Zyprexa PS Initial or Prolonged Increased Health Nifedipine C Delirium Professional Phenprocoumon C Hyperbilirubinaemia Other Pyrexia Date:03/05/98ISR Number: 3047439-7Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Convulsion Grand Mal Convulsion Date:03/06/98ISR Number: 3049468-6Report Type:Direct Company Report # Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Olanzapine PS 1 HS 5 MON Hospitalization - Phosphokinase Increased Professional Initial or Prolonged Muscle Rigidity Other Neuroleptic Malignant Required Syndrome Intervention to Pyrexia Prevent Permanent Impairment/Damage Date:03/06/98ISR Number: 3127898-1Report Type:Periodic Company Report #8-97084-001B Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Effexor PS ORAL 225MG IN AM & Professional 150MG IN PM ORAL Clozaril SS ORAL ORAL 24-Jun-2005 12:19 PM Page: 237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax SS ORAL 1MG THREE TIMES DAILY AND 2MG AT BEDTIME ORAL Zeprexa SS ORAL ORAL Clozaril C Zyprexa C Atenolol C Provera C Premarin C Lithium C Mellaril C Date:03/06/98ISR Number: 3128698-9Report Type:Periodic Company Report #8-97093-002B Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Effexor PS ORAL 225 MG DAILY Professional ORAL, 150 MG DAILY Zyprexa SS 10 MG DAILY THEN 5 MG DAILY Date:03/09/98ISR Number: 3049016-0Report Type:Expedited (15-DaCompany Report #CA97122977A Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Phosphokinase Increased Health DAILY PO Other Blood Pressure Decreased Professional Epival C Body Temperature Increased Chorea Delirium Drooling Drug Level Below Therapeutic Dysphagia Hallucination Hyperhidrosis Lack Of Spontaneous Speech Muscle Rigidity Mutism Parkinsonian Gait Posturing Psychotic Disorder Urinary Incontinence Date:03/09/98ISR Number: 3049020-2Report Type:Expedited (15-DaCompany Report #US9701160A Age:16 YR Gender: I/FU:F Outcome Hospitalization - Initial or Prolonged Other Required 24-Jun-2005 12:19 PM Page: 238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 10.00 MG Abdominal Rigidity Professional DAILY PO Abdominal Tenderness Depakene C Blood Creatine Increased Lorazepam C Blood Urea Increased Haloperidol C Cholelithiasis Tigan C Condition Aggravated Congenital Anomaly Depression Hallucination, Auditory Liver Function Test Abnormal Nausea Respiratory Disorder Schizoaffective Disorder Urinary Incontinence Vomiting Date:03/09/98ISR Number: 3049023-8Report Type:Expedited (15-DaCompany Report #IL98021159A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa PS ORAL 10.00 MG Hospitalization - Clostridium Colitis Health 2/DAY PO Initial or Prolonged Dermatitis Professional Carbamazepine C Dermatitis Exfoliative Haldol C Diarrhoea Valium C Dyspnoea Quinidine C Eosinophilia Clonazepam C Eyelid Oedema Haemolytic Anaemia Heart Rate Irregular Hypersensitivity Liver Function Test Abnormal Lymphadenopathy Pneumonia Pruritus Pyrexia Respiratory Disorder Rhonchi Urticaria Date:03/09/98ISR Number: 3049130-XReport Type:Expedited (15-DaCompany Report #IL98030001A Age:69 YR Gender:Male I/FU:I Outcome PT Life-Threatening Asthenia Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Dyspnoea Fall Myocardial Infarction Neuroleptic Malignant Syndrome Pneumonia 24-Jun-2005 12:19 PM Page: 239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Oedema Pyrexia Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa PS ORAL 10.00 MG Increased Health DAILY PO Professional Tegretol C 002 DAY Ikacor C 2 D Date:03/09/98ISR Number: 3049135-9Report Type:Expedited (15-DaCompany Report #DE98030472A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL PO Health Professional Date:03/09/98ISR Number: 3049139-6Report Type:Expedited (15-DaCompany Report #FI98030532A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Health DAILY PO Professional Lithium C Other Fevarin C Date:03/09/98ISR Number: 3049415-7Report Type:Expedited (15-DaCompany Report #DE98024987A Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS ORAL 25 MG Initial or Prolonged Aminotransferase Health Neurocil C Increased Professional Taxilan C Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Lung Infiltration Pneumonia Pyrexia Rhabdomyolysis Date:03/09/98ISR Number: 3049418-2Report Type:Expedited (15-DaCompany Report #FR98015077A Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa PS ORAL 5 MG DAILY Drug Level Above Health Anafranil C Therapeutic Professional Daonil C Tercian C Lepticur C 24-Jun-2005 12:19 PM Page: 240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/98ISR Number: 3049343-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Disturbance In Attention Zyprexa PS ORAL Paramnesia Seroquil SS ORAL 5MG Schizophrenia TWICE/DAILY Verbigeration Date:03/12/98ISR Number: 3055280-4Report Type:Expedited (15-DaCompany Report #US98025635A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS Initial or Prolonged Tachycardia Professional Haloperidol C Date:03/12/98ISR Number: 3059160-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Olanzepine PS Lilly ORAL 10 MG PO QD Initial or Prolonged Phosphokinase Increased Professional Depakote C Depressed Level Of Ativan C Consciousness Dyspnoea Lethargy Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia White Blood Cell Count Increased Date:03/12/98ISR Number: 3134779-6Report Type:Periodic Company Report #JAUSA-26890 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 6 MG DAILY ORAL Zyprexa SS ORAL DAILY ORAL Lithium C Congentin C Date:03/12/98ISR Number: 3137968-XReport Type:Periodic Company Report #JAUSA-26529 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal Hypercholesterolaemia (Risperidone) Janssen, Tablet PS Janssen ORAL DAILY ORAL Zyprexa (Olanzapine) Tablet SS ORAL DAILY ORAL 24-Jun-2005 12:19 PM Page: 241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139957-8Report Type:Periodic Company Report #JAUSA-28968 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal Professional (Risperidone), Janssen, Tablet 3mg PS Janssen ORAL 3 MG 2 DAILY ORAL/2 MG 2 DAILY ORAL Olanzapine SS 50MG 1 DAILY - TAKEN AT BEDTIME Benztropine C Date:03/12/98ISR Number: 3140466-0Report Type:Periodic Company Report #JAUSA-26983 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Increased Appetite ORAL; 4 MG Sedation DAILY 7 WK Speech Disorder Olanzapine SS ORAL 10 MG DAILY ORAL Date:03/12/98ISR Number: 3144924-4Report Type:Periodic Company Report #JAUSA-29333 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged ORAL Zyprexa SS ORAL ORAL Date:03/12/98ISR Number: 3146653-XReport Type:Periodic Company Report #JAUSA-27541 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Muscle Contractions Professional (Risperidone) PS Janssen ORAL SEE IMAGE Involuntary Haldol (Haloperidol) SS Janssen ORAL 1 MG 2 DAILY ORAL Zyprexa (Olanzapine) SS ORAL SEE IMAGE 9 WK Prozac (Fluoxetine) C Depakote C Eskalith C Atenolol C Date:03/13/98ISR Number: 3066744-1Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Zyprexa PS Lilly 10MG QD Initial or Prolonged Prolixin C Benztropine C 24-Jun-2005 12:19 PM Page: 242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/98ISR Number: 3055174-4Report Type:Expedited (15-DaCompany Report #DE98022377A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa PS 5 MG Initial or Prolonged Dermatitis Health Dysphagia Professional Leukopenia Lymphadenopathy Nausea Neutropenia Pyrexia Rash Erythematous Vomiting Date:03/16/98ISR Number: 3055177-XReport Type:Expedited (15-DaCompany Report #US98010442A Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Therapeutic Agent Professional Haloperidol C Toxicity Cogentin C Date:03/16/98ISR Number: 3055188-4Report Type:Expedited (15-DaCompany Report #DE98024987A Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Zyprexa PS 25 MG/1 DAY Hospitalization - Aminotransferase Health Neurocil C Initial or Prolonged Increased Professional Taxilan C Blood Creatine Phosphokinase Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Lung Infiltration Pneumonia Pyrexia Renal Failure Acute Rhabdomyolysis Transient Ischaemic Attack Date:03/16/98ISR Number: 3055249-XReport Type:Expedited (15-DaCompany Report #US_980300067 Age:71 YR Gender:Female I/FU:I Outcome PT Death Cardiac Failure Hospitalization - Congestive Initial or Prolonged Leukocytosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Paraesthesia Pyrexia Respiratory Failure Sepsis 24-Jun-2005 12:19 PM Page: 243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 7.5 MG/1 DAY Professional Risperdal C Other Date:03/16/98ISR Number: 3055251-8Report Type:Expedited (15-DaCompany Report #US_980300062 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS Initial or Prolonged Overdose Professional Clozaril C Norflex C Motrin C Amoxicillin C Elavil C Clonazepam C Date:03/16/98ISR Number: 3055253-1Report Type:Expedited (15-DaCompany Report #US_980300015 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Zyprexa PS 10 MG/1 DAY 1 DAY Health Haloperidol C Professional Date:03/16/98ISR Number: 3055277-4Report Type:Expedited (15-DaCompany Report #US98023787A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS 40 MG / 1 DAY 3 MON Initial or Prolonged Arrhythmia Professional Dilantin C Bilirubinuria Other Hyperbilirubinaemia Hyponatraemia Liver Function Test Abnormal Nausea Supraventricular Tachycardia Thrombocytopenia Vomiting Date:03/19/98ISR Number: 3057767-7Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Zyprexa PS Lilly 30 MG QHS AND Phosphokinase Increased 10 MG Q AM Cardiac Arrest Amantadine SS 100 MG BID Drug Withdrawal Syndrome Serzone C Intestinal Ischaemia Synthroid C Lung Infiltration Ativan C Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/98ISR Number: 3057870-1Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Discharge Olanzapine PS ORAL 10MG PO QD Trifluperazine C Benztropine C Date:03/19/98ISR Number: 3080150-5Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Olanzapine PS ORAL 10MG PO Muscle Rigidity Salivary Hypersecretion Date:03/20/98ISR Number: 3057468-5Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Olanzapine PS 10MG; QD Intervention to Feeling Abnormal Albuterol Inhaler C Prevent Permanent Alprazola, C Impairment/Damage Benztropine C Captopril C Colace C Ensure C Lasix C Ibuprophen C Locapine C Tretal C Potassium C Darvocet N-100 C Trazadone C Date:03/20/98ISR Number: 3057475-2Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dermatitis Olanzapine PS 10MG; 1 Q D Intervention to Cimetidine C Prevent Permanent Bupropine C Impairment/Damage Date:03/23/98ISR Number: 3059173-8Report Type:Expedited (15-DaCompany Report #US98023787A Age:41 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Arrhythmia Bilirubinuria Hyperbilirubinaemia Hyponatraemia Liver Function Test Abnormal Nausea Supraventricular Tachycardia 24-Jun-2005 12:19 PM Page: 245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenia Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 40 MG/1 DAY Professional Dilantin (Phenytoin Other Sodium) C Prozac (Fluoxetine Hydrochloride) C Furosemide C Date:03/23/98ISR Number: 3059176-3Report Type:Expedited (15-DaCompany Report #US-980300067 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Hospitalization - Congestive Professional Risperdal Initial or Prolonged Depressed Level Of Other (Risperidone) C Consciousness Leukocytosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Pyrexia Respiratory Failure Sepsis Tremor Date:03/23/98ISR Number: 3059198-2Report Type:Expedited (15-DaCompany Report #DE98024987A Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Zyprexa PS 25 MG/DAY Hospitalization - Aminotransferase Health Neurocil C Initial or Prolonged Increased Professional Taxilan C Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Pneumonia Pyrexia Renal Failure Acute Rhabdomyolysis Date:03/23/98ISR Number: 3059201-XReport Type:Expedited (15-DaCompany Report #GB98022263A Age:44 YR Gender:Male I/FU:F Outcome PT Death Apnoea Atrial Septal Defect Blood Creatine Phosphokinase Increased Body Temperature Increased Cardiac Arrest Cardiac Failure Cardio-Respiratory Arrest Catatonia 24-Jun-2005 12:19 PM Page: 246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Hepatic Necrosis Hepatic Steatosis Report Source Product Role Manufacturer Route Dose Duration Hyperplasia Foreign Zyprexa (Olanzapine) PS 10 MG Hypotension Health Lofepramine C Hypotonia Professional Myocardial Infarction Company Myocarditis Representative Neuroleptic Malignant Syndrome Pulmonary Congestion Respiratory Arrest Respiratory Rate Increased Spleen Disorder Tachypnoea Date:03/23/98ISR Number: 3059203-3Report Type:Expedited (15-DaCompany Report #US98022107A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Acetaminophen C Propoxyphene C Valproic Acid C Clonazepam C Fluvoxamine C Remeron C Humulin R C Rezulin C Gemfibrozil C Date:03/23/98ISR Number: 3059205-7Report Type:Expedited (15-DaCompany Report #US97124414A Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Intentional Misuse Professional Risperdal C Date:03/23/98ISR Number: 3059207-0Report Type:Expedited (15-DaCompany Report #IL98030001A Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa PS 10 MG/ 1DAY Hospitalization - Blood Creatine Health Tegretol C Initial or Prolonged Phosphokinase Increased Professional Ikacor C Dyspnoea Dyspnoea Exacerbated Fall Myocardial Infarction Neuroleptic Malignant Syndrome Pneumonia Pulmonary Oedema Pyrexia Rhabdomyolysis White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/98ISR Number: 3059208-2Report Type:Expedited (15-DaCompany Report #GB98025236A Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa PS Syndrome Health Pneumonia Professional Company Representative Date:03/23/98ISR Number: 3059210-0Report Type:Expedited (15-DaCompany Report #GB97050760A Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Foreign Zyprexa PS 10 MG Hospitalization - Arrhythmia Health Ethanol C Initial or Prolonged Brain Hypoxia Professional Diazepam C Loss Of Consciousness Respiratory Depression Date:03/23/98ISR Number: 3059234-3Report Type:Expedited (15-DaCompany Report #FR52-00460 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertonia Foreign Zyprexa PS ORAL 10MG\QD\PO Tremor Cogentin SS 500 MCG\QD Date:03/23/98ISR Number: 3061290-3Report Type:Expedited (15-DaCompany Report #EWC980300041 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS ORAL 15 MG/DAY Health Professional Date:03/23/98ISR Number: 3061292-7Report Type:Expedited (15-DaCompany Report #JP97010424A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS 12.5 MG DAY Initial or Prolonged Akathisia Study Nitrazepam C Anaemia Health Haloperidol C Dizziness Professional Sennoside A C Gastric Ulcer Company Insomnia Representative Melaena Date:03/23/98ISR Number: 3061296-4Report Type:Expedited (15-DaCompany Report #US_98300208 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Zyprexa PS Phosphokinase Increased Professional Amantadine C Chest Pain Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/98ISR Number: 3061301-5Report Type:Expedited (15-DaCompany Report #US_980300148 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Zyprexa PS 7 MON Initial or Prolonged Distress Syndrome Professional Date:03/23/98ISR Number: 3061303-9Report Type:Expedited (15-DaCompany Report #US-980300213 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Consumer Zyprexa PS Zoloft C Date:03/23/98ISR Number: 3061304-0Report Type:Expedited (15-DaCompany Report #GBS980300008 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 20 MG/1 DAY Initial or Prolonged Phosphokinase Increased Health Carbamazepine C Delirium Professional Valproate Sodium C Hypertension Thyroxine Sodium C Pyrexia Orphenadrine C Tachycardia Urinary Incontinence Date:03/23/98ISR Number: 3061307-6Report Type:Expedited (15-DaCompany Report #US-980300059 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS 30 MG/1 DAY 5 MON Initial or Prolonged Diabetes Mellitus Professional Prozac SS 20 MG/2 DAY 3 YR Insulin-Dependent Depakote C Diabetic Ketoacidosis Ketoacidosis Date:03/24/98ISR Number: 3056276-9Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS ORAL 20 MG PO Q HS Initial or Prolonged Dermatitis Professional Prozac C Liver Function Test Synthroid C Abnormal Paxil C Pyrexia Multivitamins C Vomiting White Blood Cell Count Decreased Date:03/27/98ISR Number: 3062374-6Report Type:Expedited (15-DaCompany Report #JP97010424A Age:49 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Akathisia Anaemia Dizziness 24-Jun-2005 12:19 PM Page: 249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastric Ulcer Gastrointestinal Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Melaena Foreign Zyprexa PS 12.5 MG DAY Study Nitrazepam C Health Haloperidol C Professional Sennoside A C Company Representative Date:03/27/98ISR Number: 3131462-8Report Type:Periodic Company Report #A001-002-001791 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Aricept PS ORAL 10 MG (1 IN 1 Initial or Prolonged Professional D), PER ORAL Disability Zyprexa SS ORAL PER ORAL Propranolol C Aleve C Bactrim C Multivitamin C Date:03/31/98ISR Number: 3058815-0Report Type:Expedited (15-DaCompany Report #JP97010424A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS 12.5 MG DAY Initial or Prolonged Akathisia Study Nitrazepam C Anaemia Health Haloperidol C Dizziness Professional Sennoside A C Gastric Ulcer Company Melaena Representative Date:03/31/98ISR Number: 3063204-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Zyprexa PS 2.5MG BID; Syndrome 5MG H.S. Eskalith Cr C Desyrel C Losartan C Lorazepam C Ntg Patch C Pepcid C Aspirin C Cardura C Date:03/31/98ISR Number: 3064282-3Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Zyprexa PS ORAL 2.5 MG PO QD Atenolol SS ORAL 25 MG PO QD Acetaminophen C Warfarin C Oxycodone C 24-Jun-2005 12:19 PM Page: 250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glipizide C Docusate C Maxide C Haldol C Insulin C Thiamine C Date:03/31/98ISR Number: 3067135-XReport Type:Direct Company Report # Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Zyprexa PS 50MG 1 TAB Initial or Prolonged Convulsion DAILY Fall Nervousness Date:04/01/98ISR Number: 3058297-9Report Type:Expedited (15-DaCompany Report #US_980300416 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Induced Health Zyprexa PS 20 MG/1 DAY Professional Zolft (Sertraline Hydrochloride) C Procardia (Nifedipine) C Daypro (Oxaprozin) C Bentyl (Dicycloverine Hydrochoride) C Prevacid (Lansoprazole) C Tylenol Pm C Perphenazine C Date:04/01/98ISR Number: 3058299-2Report Type:Expedited (15-DaCompany Report #CA97013037A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 12.5 MG/ 1 Overdose Health DAY Professional Ferrous Sulfate C Multivitamin C Folic Acid C Zopiclone C Methotrimeprazine (Levomepromazine) C Benztropine (Benzatropine) C Date:04/01/98ISR Number: 3058813-7Report Type:Expedited (15-DaCompany Report #EWC980300101 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zyprexa PS Initial or Prolonged Health Professional Other 24-Jun-2005 12:19 PM Page: 251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/98ISR Number: 3058816-2Report Type:Expedited (15-DaCompany Report #EWC980300119 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS 300 MG/DAY Initial or Prolonged Dyskinesia Health Taxilan C Hyporeflexia Professional Atosil C Suicide Attempt Date:04/01/98ISR Number: 3058817-4Report Type:Expedited (15-DaCompany Report #EWC980300103 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Hospitalization - Health Initial or Prolonged Professional Date:04/01/98ISR Number: 3058820-4Report Type:Expedited (15-DaCompany Report #FR98011009A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Interstitial Lung Disease Health Athymil C Neutrophil Count Professional Nozinan C Increased Lexomil C Date:04/01/98ISR Number: 3058822-8Report Type:Expedited (15-DaCompany Report #GB98024288A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS 500 MG Initial or Prolonged Overdose Health Thioridazine C Suicide Attempt Professional Other Date:04/01/98ISR Number: 3058824-1Report Type:Expedited (15-DaCompany Report #US97082584A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Health Zyprexa PS 10 MG / 1 DAY Initial or Prolonged Genitalia External Professional Paxil C Painful Company Clonazepam C Priapism Representative Date:04/01/98ISR Number: 3058826-5Report Type:Expedited (15-DaCompany Report #US97124414A Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Therapeutic Agent Professional Risperdal C Toxicity 24-Jun-2005 12:19 PM Page: 252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/98ISR Number: 3058828-9Report Type:Expedited (15-DaCompany Report #US98021327A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS 25 MG/1 DAY Granulomatous Liver Professional Valproic Acid C Disease Company Lorazepam C Hepatic Steatosis Representative Insulin C Jaundice Tolazamide C Skin Discolouration Clonazepam C Clindamycin C Effexor C Proventil C Atrovent C Serevent C Date:04/01/98ISR Number: 3058831-9Report Type:Expedited (15-DaCompany Report #US98025638A Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa PS 1.25 MG/1DAY 1 MON Initial or Prolonged Overdose Professional Sinus Tachycardia Date:04/01/98ISR Number: 3058833-2Report Type:Expedited (15-DaCompany Report #US-980300419 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa PS 5 MG/2 DAY Agitation Health Kemardrin C Arrhythmia Professional Ativan C Confusional State Haldol C Disorientation Pulmonary Oedema Speech Disorder Date:04/01/98ISR Number: 3064585-2Report Type:Direct Company Report # Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Generalised Health Olanzapine PS ORAL 5 MG PO QHS Professional Clonazepam C Ativan C Dilcor Xr C Aspirin C Date:04/01/98ISR Number: 3071851-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Zyprexa PS ORAL 5MG, PO, I Convulsion HS. Hyperhidrosis Zoloft SS ORAL 100 MG, PO HS 24-Jun-2005 12:19 PM Page: 253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3061390-8Report Type:Expedited (15-DaCompany Report #US98012299A Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Zyprexa PS 5 MG/ 2 DAY 4 MON Professional Date:04/07/98ISR Number: 3061391-XReport Type:Expedited (15-DaCompany Report #US97090670A Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Health Zyprexa PS Exposure To Therapeutic Professional Drugs Other Congenital Anomaly Dyskinesia Low Set Ears Pterygium Colli Date:04/07/98ISR Number: 3061392-1Report Type:Expedited (15-DaCompany Report #US97094903A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Accidental Exposure Health Zyprexa PS 10 MG 1 DAY Anencephaly Professional Haldol C Congentin C Vistaril C Klonopin C Date:04/07/98ISR Number: 3062371-0Report Type:Expedited (15-DaCompany Report #US98010142A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zyprexa PS Life-Threatening Acidosis Professional D4t C Bradycardia Epivir C Cardio-Respiratory Arrest Diflucan C Nausea Psychotic Disorder Sepsis Vomiting Date:04/07/98ISR Number: 3062377-1Report Type:Expedited (15-DaCompany Report #US 980300660 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS 10 MG/1 DAY Initial or Prolonged Hallucinations, Mixed Health Placebo SS 1 U/2 DAY Professional Date:04/07/98ISR Number: 3063332-8Report Type:Expedited (15-DaCompany Report #8-98086-028A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Foreign Stangyl PS ORAL 250 MD DAILY Abnormal Health ORAL Grand Mal Convulsion Professional Diazepam SS ORAL 40 MG DAILY 24-Jun-2005 12:19 PM Page: 254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report UNTIL 1/16 THEN 5 MG DAILY Lithium Carbonate SS 1000 MG DAILY Olanzapine SS 20 MG DAILY THEN 30 MG DAILY SINCE 2/4 Date:04/07/98ISR Number: 3064155-6Report Type:Expedited (15-DaCompany Report #US 980301068 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Zyprexa PS 20 MG/DAY Initial or Prolonged Mania Health Zoloft C Movement Disorder Professional Nightmare Priapism Date:04/07/98ISR Number: 3064159-3Report Type:Expedited (15-DaCompany Report #GBS 980300162 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS 15 MG/1 DAY Initial or Prolonged Chest Pain Health Ranitidine C Professional Company Representative Date:04/07/98ISR Number: 3064161-1Report Type:Expedited (15-DaCompany Report #GBS980300133 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS Initial or Prolonged Anger Consumer Date:04/07/98ISR Number: 3064163-5Report Type:Expedited (15-DaCompany Report #EWC 980300169 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Health Beloc C Professional Moduretik C Anafranil C Hypnorex C Lopirin C Date:04/07/98ISR Number: 3064165-9Report Type:Expedited (15-DaCompany Report #EWC980300167 Age:54 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Alanine Aminotransferase Increased Aspartate Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Alkaline Phosphatase Increased Cholecystitis Report Source Product Role Manufacturer Route Dose Duration Cholelithiasis Foreign Zyprexa PS 15 MG/DAY Condition Aggravated Health Fevarin C Decreased Appetite Professional Gamma-Glutamyltransferase Increased Nausea Date:04/07/98ISR Number: 3064166-0Report Type:Expedited (15-DaCompany Report #EWC980300147 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 20 MG/DAY Health Tegretol C Professional Tavor C Date:04/07/98ISR Number: 3064169-6Report Type:Expedited (15-DaCompany Report #EWC980300146 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Health Digoxin C Professional Furosemide C Company Nitromint C Representative Gilemal C Date:04/07/98ISR Number: 3064171-4Report Type:Expedited (15-DaCompany Report #EWC980300216 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa PS Initial or Prolonged Health Daktarin C Professional Seropram C Date:04/07/98ISR Number: 3064174-XReport Type:Expedited (15-DaCompany Report #EWC980300200 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Misuse Foreign Zyprexa PS Hospitalization - Suicide Attempt Health Kemadrin C Initial or Prolonged Professional Protazin C Date:04/07/98ISR Number: 3064177-5Report Type:Expedited (15-DaCompany Report #US_980300698 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS 7.5 MG/2 DAY Initial or Prolonged Professional Azt C Lamivudine C Iron C Thorazine C 24-Jun-2005 12:19 PM Page: 256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3066427-8Report Type:Expedited (15-DaCompany Report #US97054879A Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa PS Overdose Health Professional Date:04/07/98ISR Number: 3066429-1Report Type:Expedited (15-DaCompany Report #US98010442A Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Overdose Professional Haloperidol C Cogentin C Date:04/07/98ISR Number: 3066430-8Report Type:Expedited (15-DaCompany Report #GB98024288A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS 500 MG Initial or Prolonged Intentional Misuse Health Thioridazine C Suicide Attempt Professional Other Date:04/07/98ISR Number: 3066431-XReport Type:Expedited (15-DaCompany Report #GB98011315A Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 15 MG DAY Intentional Misuse Health Dothiepin C Professional Company Representative Date:04/07/98ISR Number: 3067111-7Report Type:Expedited (15-DaCompany Report #EWC980300052 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Foreign Zyprexa PS 20 MG / DAY Hostility Health Xanax C Logorrhoea Professional Artane C Rohypnol C Date:04/07/98ISR Number: 3067113-0Report Type:Expedited (15-DaCompany Report #EWC980300195 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Dizziness Health Fevarin C Professional Tavor C Dominal C Tenormin C 24-Jun-2005 12:19 PM Page: 257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3067121-XReport Type:Expedited (15-DaCompany Report #US-980300799 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Health Zyprexa PS UNKNOWN Exposure To Therapeutic Professional Multiple Vitamins C Drugs Death Neonatal Date:04/07/98ISR Number: 3067122-1Report Type:Expedited (15-DaCompany Report #EWC980300187 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Foreign Zyprexa PS ORAL 30 MG/DAY Abnormal Health Hypnorex C Grand Mal Convulsion Professional Stangyl C Valiquid C Date:04/07/98ISR Number: 3067127-0Report Type:Expedited (15-DaCompany Report #US_980300771 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Decreased Professional Tegretol C White Blood Cell Count Decreased Date:04/07/98ISR Number: 3067130-0Report Type:Expedited (15-DaCompany Report #US_980300592 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Zyprexa PS 20 MG/1DAY Initial or Prolonged Abnormal Professional Prozac SS White Blood Cell Count Paxil (Paroxetine Decreased Hydrochloride) C Date:04/07/98ISR Number: 3067132-4Report Type:Expedited (15-DaCompany Report #US_980300830 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Therapeutic Response Consumer Zyprexa PS 15 MG / 1 DAY 3 WK Initial or Prolonged Decreased White Blood Cell Count Decreased Date:04/07/98ISR Number: 3067136-1Report Type:Expedited (15-DaCompany Report #US_980300869 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Zyprexa PS 20 MG / 1 DAY 2 MON Initial or Prolonged Oedema Professional Risperidone C Weight Increased 24-Jun-2005 12:19 PM Page: 258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3067138-5Report Type:Expedited (15-DaCompany Report #US_980300560 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS 20 MG / 1 DAY Initial or Prolonged Euphoric Mood Professional Prolixin Decanoate C Excessive Masturbation Depakote C Insomnia Mania Date:04/07/98ISR Number: 3067142-7Report Type:Expedited (15-DaCompany Report #US98025632A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS Initial or Prolonged Loss Of Consciousness Professional Other Overdose Date:04/07/98ISR Number: 3067144-0Report Type:Expedited (15-DaCompany Report #US_ 980300679 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS UNKNOWN Initial or Prolonged Professional Date:04/07/98ISR Number: 3067151-8Report Type:Expedited (15-DaCompany Report #US_980300331 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Foreign Zyprexa PS 5 MG/1DAY Initial or Prolonged Intestinal Obstruction Study Modopar C Health Hept-A-Myl C Professional Rythmodan C Aspegic C Equanil C Lubentyl C Lubentyl C Liquid C Peristaltine C Date:04/07/98ISR Number: 3067165-8Report Type:Expedited (15-DaCompany Report #US_980300212 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Zyprexa PS NI Initial or Prolonged Wellbutrin C Remeron C Klonopin C Date:04/07/98ISR Number: 3071747-7Report Type:Direct Company Report # Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Olanzapine PS ORAL 5MG PO QHS Initial or Prolonged 24-Jun-2005 12:19 PM Page: 259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3072489-4Report Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Olanzapine PS Initial or Prolonged Date:04/10/98ISR Number: 3062767-7Report Type:Expedited (15-DaCompany Report #8-98091-019A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Effexor PS ORAL ORAL 1 DAY Other Professional Zyprexa Tablets SS ORAL 1 DAY Zyprexa Tablets C ORAL Date:04/10/98ISR Number: 3065508-2Report Type:Expedited (15-DaCompany Report #AU97122107A Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrasystoles Foreign Zyprexa PS 10MG/1 DAY Initial or Prolonged Health Chlorpromazine C Professional Date:04/10/98ISR Number: 3065510-0Report Type:Expedited (15-DaCompany Report #US 980300419 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Zyprexa PS M MG/3 DAY Agitation Kemadrin SS 5 MG/DAY Arrhythmia Methotrimeprazine C Confusional State Ativan C 1 MG/ DAY Disorientation Haldol C UNKNOWN Drug Level Above Therapeutic Intentional Self-Injury Overdose Pulmonary Oedema Speech Disorder Date:04/10/98ISR Number: 3065515-XReport Type:Expedited (15-DaCompany Report #EWC980300169 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS 10MG/DAY Initial or Prolonged Health Beloc C Professional Moduretik C Anafranil C Hypnorex C Lopirin C Date:04/13/98ISR Number: 3065122-9Report Type:Expedited (15-DaCompany Report #7395528 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Depakote PS Abbott ORAL 1.500 GM PO Initial or Prolonged Professional QD Other Zyprexa SS 24-Jun-2005 12:19 PM Page: 260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restoril C Date:04/13/98ISR Number: 3073143-5Report Type:Direct Company Report # Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Olanzapine PS ORAL 10MG PO QHS Abnormal Lithium Carborate C Lorazepam C Haloperidol C Date:04/14/98ISR Number: 3064378-6Report Type:Expedited (15-DaCompany Report #GB98011315A Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 15 MG DAY 1 YR Drug Level Above Health Dothiepin C Therapeutic Professional Overdose Company Representative Other Date:04/14/98ISR Number: 3064383-XReport Type:Expedited (15-DaCompany Report #US_980300059 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS 30 MG/1 DAY 5 MON Initial or Prolonged Insulin-Dependent Professional Prozac SS 20 MG/2DAY 3 YR Hyperglycaemia Depakote C Ketoacidosis Weight Decreased Date:04/14/98ISR Number: 3064384-1Report Type:Expedited (15-DaCompany Report #EWC980300187 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Foreign Zyprexa PS 30 MG/DAY Abnormal Health Hypnorex C Grand Mal Convulsion Professional Stangyl C Valiquid C Date:04/14/98ISR Number: 3064405-6Report Type:Expedited (15-DaCompany Report #EWC980300256 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Health Fevarin C Professional Date:04/14/98ISR Number: 3064408-1Report Type:Expedited (15-DaCompany Report #GBS980300226 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Other Grand Mal Convulsion Foreign Health 24-Jun-2005 12:19 PM Page: 261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS 5 MG DAY Date:04/14/98ISR Number: 3064442-1Report Type:Expedited (15-DaCompany Report #EWC980300254 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 20 MG/DAY Health Professional Date:04/14/98ISR Number: 3065513-6Report Type:Expedited (15-DaCompany Report #US_980300924 Age:87 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Study Health Professional Date:04/14/98ISR Number: 3065607-5Report Type:Expedited (15-DaCompany Report #US97093184A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eclampsia Health Zyprexa PS 20MG /1 AT Initial or Prolonged Gestational Diabetes Professional BED TIME Hepatic Function Abnormal 37WEEKS AND Hypertension 2 DAYS Hypothyroidism Folic Acid C Proteinuria Pepcid C Multivitamins C Synthroid C Date:04/14/98ISR Number: 3065610-5Report Type:Expedited (15-DaCompany Report #US 980401282 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Zyprexa PS ORAL 40 MG/DAY Hospitalization - Phosphokinase Increased Professional Serzone C ORAL 300MG/DAY Initial or Prolonged Cardiac Arrest Other Amantadine C 300 MG/DAY Other Intestinal Ischaemia Synthroid C .1 MG/DAY Lung Infiltration Ativan C 1.5 MG/DAY Neuroleptic Malignant Bentyl C 60 MG/DAY Syndrome Pyrexia Date:04/14/98ISR Number: 3065615-4Report Type:Expedited (15-DaCompany Report #EWC980300241 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/98ISR Number: 3066306-6Report Type:Expedited (15-DaCompany Report #EWC980400282 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zyprexa PS Syndrome Health Lithium C Professional Date:04/14/98ISR Number: 3066309-1Report Type:Expedited (15-DaCompany Report #EWC980400284 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zyprexa PS Syndrome Health Professional Date:04/14/98ISR Number: 3066311-XReport Type:Expedited (15-DaCompany Report #EWC980400267 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 10 MG /DAY Initial or Prolonged Phosphokinase Increased Health Panangin C Muscle Rigidity Professional Diaphyllin C Neuroleptic Malignant Company Syndrome Representative Other Date:04/14/98ISR Number: 3066313-3Report Type:Expedited (15-DaCompany Report #US 980401243 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Zyprexa PS 60 MG/1DAY 1 YR Initial or Prolonged Syncope Professional Company Representative Date:04/14/98ISR Number: 3066316-9Report Type:Expedited (15-DaCompany Report #US 980401305 Age:66 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Zyprexa PS 20 MG/1 DAY Initial or Prolonged Decreased Professional Synthroid C Delusion Risperdal C Oxygen Saturation Neurontin C Decreased Lorazepam C Pneumonia Syncope Date:04/14/98ISR Number: 3066320-0Report Type:Expedited (15-DaCompany Report #US_980401339 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Zyprexa PS Initial or Prolonged Exposure To Therapeutic Professional Drugs Hypoglycaemia Respiratory Distress 24-Jun-2005 12:19 PM Page: 263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/98ISR Number: 3066322-4Report Type:Expedited (15-DaCompany Report #EWC980300243 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 15 MG/DAY Health Professional Company Representative Date:04/14/98ISR Number: 3066365-0Report Type:Expedited (15-DaCompany Report #GBS980300227 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zyprexa PS 20MG DAY Syndrome Health Valproate Sodium C Professional Carbamazepine C Other Orphenadrine C Thyroxine Sodium C Date:04/14/98ISR Number: 3066366-2Report Type:Expedited (15-DaCompany Report #US97011660A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Zyprexa PS 10 MG DAY Initial or Prolonged Abdominal Rigidity Depakene C Other Abdominal Tenderness Lorazepam C Required Acute Abdomen Haloperidol C Intervention to Cholelithiasis Tigan C Prevent Permanent Condition Aggravated Risperidone C Impairment/Damage Dyspnoea Hallucination, Auditory Hepatitis Ileus Paralytic Liver Function Test Abnormal Nausea Pancreatitis Renal Failure Respiratory Distress Urinary Incontinence Vomiting Date:04/14/98ISR Number: 3072530-9Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Zyprexa PS 2 X 10 MG. Initial or Prolonged Sepsis HS Tachycardia Thorazine C Reglan C Symmetril C 24-Jun-2005 12:19 PM Page: 264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/98ISR Number: 3066010-4Report Type:Expedited (15-DaCompany Report #EWC980300256 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Health Fevarin C Professional Date:04/21/98ISR Number: 3066013-XReport Type:Expedited (15-DaCompany Report #CA97112086A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Foreign Zyprexa PS 5 MG 1 DAY Initial or Prolonged Anaemia Megaloblastic Health Valproic Acid C Other Condition Aggravated Professional Cogentin C Folate Deficiency Tazocin C Haemoglobin Decreased Pancytopenia Pyrexia Date:04/21/98ISR Number: 3066042-6Report Type:Expedited (15-DaCompany Report #EWC980400282 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zyprexa PS Syndrome Health Lithium C Professional Date:04/21/98ISR Number: 3066045-1Report Type:Expedited (15-DaCompany Report #US-980300924 Age:87 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Study Health Professional Date:04/21/98ISR Number: 3067171-3Report Type:Expedited (15-DaCompany Report #EWC980300167 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS 15MG / DAY Initial or Prolonged Cholelithiasis Health Fevarin C Condition Aggravated Professional Decreased Appetite Liver Function Test Abnormal Nausea Date:04/22/98ISR Number: 3073692-XReport Type:Expedited (15-DaCompany Report #EWC980400346 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS UNKNOWN UNKNOWN Health Professional 24-Jun-2005 12:19 PM Page: 265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/98ISR Number: 3073693-1Report Type:Expedited (15-DaCompany Report #EWC980400327 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa PS UNKNOWN 10 MG DAY Initial or Prolonged Gait Disturbance Health Muscle Rigidity Professional Orthostatic Hypotension Sleep Disorder Date:04/22/98ISR Number: 3073696-7Report Type:Expedited (15-DaCompany Report #EWC980400355 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa PS UNKNOWN 337.5 MG/DAY Initial or Prolonged Coma Health Dysarthria Professional Intentional Misuse Muscle Rigidity Sinus Tachycardia Date:04/22/98ISR Number: 3076842-4Report Type:Expedited (15-DaCompany Report #US_980300212 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS Initial or Prolonged Professional Wellbutrin C Remeron C Klonopin C Date:04/22/98ISR Number: 3076850-3Report Type:Expedited (15-DaCompany Report #EWC980400337 Age:22 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine PS Health Professional Date:04/22/98ISR Number: 3076851-5Report Type:Expedited (15-DaCompany Report #EWC980400332 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Zyprexa PS 20MG/DAY Hospitalization - Coma Health Nozinan C Initial or Prolonged Hypothermia Professional Overdose Shock Date:04/22/98ISR Number: 3076852-7Report Type:Expedited (15-DaCompany Report #EWC980400328 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS Initial or Prolonged Memory Impairment Health Temazepam C Photophobia Professional Dalmadorm C Suicide Attempt Oxazepam C Visual Acuity Reduced Lithium C 24-Jun-2005 12:19 PM Page: 266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/98ISR Number: 3076853-9Report Type:Expedited (15-DaCompany Report #EWC980400325 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Foreign Zyprexa PS Hospitalization - Health Initial or Prolonged Professional Date:04/22/98ISR Number: 3076854-0Report Type:Expedited (15-DaCompany Report #US_980401337 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Study Olanzapine PS 7.5 MG/DAY Hospitalization - Distress Syndrome Health Prevacid C Initial or Prolonged Aggression Professional Alprazolam C Chest Pain Atenolol C Condition Aggravated Furosemide C Dehydration Nitroglycerin C Dyspnoea Trazodone C Malaise Oxygen Saturation Decreased Pulmonary Embolism Screaming White Blood Cell Count Increased Date:04/22/98ISR Number: 3076855-2Report Type:Expedited (15-DaCompany Report #US_980401194 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Zyprexa PS 7.5 MG/1 AT Initial or Prolonged Condition Aggravated Health BEDTIME 3 WK Mania Professional Date:04/22/98ISR Number: 3076856-4Report Type:Expedited (15-DaCompany Report #GBS980300188 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Foreign Zyprexa PS Intentional Self-Injury Health Trifluoperazine C Professional Venlafaxine C Date:04/22/98ISR Number: 3076859-XReport Type:Expedited (15-DaCompany Report #EWC980400314 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prothrombin Level Foreign Zyprexa PS 10MG/DAY Initial or Prolonged Decreased Health Weight Increased Professional Date:04/22/98ISR Number: 3076860-6Report Type:Expedited (15-DaCompany Report #EWC980400299 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Akathisia Foreign Initial or Prolonged Psychotic Disorder Health 24-Jun-2005 12:19 PM Page: 267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS 15MG/DAY Lorazepam C Date:04/22/98ISR Number: 3076862-XReport Type:Expedited (15-DaCompany Report #GBS980300226 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Zyprexa PS 5MG DAY Health Professional Other Date:04/22/98ISR Number: 3077218-6Report Type:Expedited (15-DaCompany Report #US 980300771 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Neutrophil Count Professional Tegretol C Decreased White Blood Cell Count Decreased Date:04/22/98ISR Number: 3077219-8Report Type:Expedited (15-DaCompany Report #GBS980300227 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zyprexa PS 20MG DAY Syndrome Health Valproate Sodium C Professional Carbamazepine C Other Orphenadrine C Thyroxine C Date:04/22/98ISR Number: 3077220-4Report Type:Expedited (15-DaCompany Report #EWC 980300064 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS 10 MG/ DAY Initial or Prolonged Arterial Occlusive Health Madopar C Disease Professional Deprenyl C Constipation Sectral C Faecaloma Equanil C Haematuria Impaired Gastric Emptying Intestinal Obstruction Urinary Retention Date:04/22/98ISR Number: 3077232-0Report Type:Expedited (15-DaCompany Report #US_980401676 Age:59 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cardiac Failure Initial or Prolonged Congestive Delirium 24-Jun-2005 12:19 PM Page: 268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Diabetes Mellitus Fatigue Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS 10MG/ IN THE Hypervigilance Professional EVENING Oedema Lithium C Renal Failure Date:04/22/98ISR Number: 3077234-4Report Type:Expedited (15-DaCompany Report #US_980401326 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa PS 10MG/D Initial or Prolonged Cholecystitis Health Haloperidol C Jaundice Professional Sodium Valproate C Liver Function Test Abnormal Date:04/22/98ISR Number: 3077236-8Report Type:Expedited (15-DaCompany Report #US-980401311 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS 20 MG/1 DAY Initial or Prolonged Erection Increased Professional Depakote C Other Restoril C Date:04/23/98ISR Number: 3072751-5Report Type:Direct Company Report # Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Zyprexa PS ORAL 5 MG ORAL: TAB Amantadine C Baclofen C Lorazepam C Date:04/27/98ISR Number: 3071180-8Report Type:Expedited (15-DaCompany Report #FLUV001980059 Age:98 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Fevarin PS ORAL 50 MG - 100 Initial or Prolonged Cholelithiasis Health MG PER ORAL Decreased Appetite Professional Zyprexa SS ORAL 5 MG Hepatic Steatosis Nausea Date:04/28/98ISR Number: 3070944-4Report Type:Expedited (15-DaCompany Report #AU98030451A Age:32 YR Gender:Male I/FU:I Outcome PT Hospitalization - Fall Initial or Prolonged Feeling Cold Other Hallucination Headache Hyperhidrosis Insomnia 24-Jun-2005 12:19 PM Page: 269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Parkinson'S Disease Report Source Product Role Manufacturer Route Dose Duration Foreign Zyperxa PS 5 MG / 1 DAY Health Pergolide C Professional Eldepryl C Other Sinemet C Bi-Quinate C Omeprazole C Cardizem C Lasix C Valium C Temazepam C Date:04/28/98ISR Number: 3070950-XReport Type:Expedited (15-DaCompany Report #EWC 980400328 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS Initial or Prolonged Memory Impairment Health Temazepam C Photophobia Professional Dalmadorm C Suicide Attempt Oxazepam C Visual Acuity Reduced Lithium C Date:04/28/98ISR Number: 3070953-5Report Type:Expedited (15-DaCompany Report #US_980401900 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Disorder Health Zyprexa PS 10 MG/1 DAY 8 MON Professional Date:04/28/98ISR Number: 3070955-9Report Type:Expedited (15-DaCompany Report #US_980401976 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS 5 MG / 1 DAY Initial or Prolonged Psychotic Disorder Study Risperdal C Health Sinogan C Professional Date:04/28/98ISR Number: 3070958-4Report Type:Expedited (15-DaCompany Report #US_980402111 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa PS 20 MG/ 1 DAY 6 MON Therapeutic Professional Lithium C Depakote C Tylenol W/ Codeine No. 3 C Date:04/28/98ISR Number: 3070960-2Report Type:Expedited (15-DaCompany Report #US_980401959 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Convulsion Foreign Initial or Prolonged Study 24-Jun-2005 12:19 PM Page: 270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Product Role Manufacturer Route Dose Duration Zyprexa PS 10 MG / 1DAY Clopixol C Date:04/28/98ISR Number: 3070962-6Report Type:Expedited (15-DaCompany Report #GBS980400346 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS Initial or Prolonged Health Professional Date:04/28/98ISR Number: 3070986-9Report Type:Expedited (15-DaCompany Report #US_980401311 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Zyprexa PS 20MG/1 DAY Initial or Prolonged Professional Depakote C Date:04/29/98ISR Number: 3074622-7Report Type:Expedited (15-DaCompany Report #US_980401282 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Zyprexa PS 40 MG / DAY Hospitalization - Phosphokinase Increased Professional Serzone C Initial or Prolonged Cardiac Arrest Other Amantadine C Other Drug Withdrawal Syndrome Synthroid C Intestinal Ischaemia Ativan C Lung Infiltration Bentyl C Neuroleptic Malignant Syndrome Pyrexia Date:04/29/98ISR Number: 3074626-4Report Type:Expedited (15-DaCompany Report #DE98022377A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa PS 5 MG Initial or Prolonged Dermatitis Health Penicillin C Dysphagia Professional Erythema Infectious Mononucleosis Leukopenia Lymphadenopathy Nausea Neutropenia Pneumonia Mycoplasmal Pyrexia Rash Erythematous Viral Infection Vomiting X-Ray Abnormal 24-Jun-2005 12:19 PM Page: 271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/98ISR Number: 3074631-8Report Type:Expedited (15-DaCompany Report #US98010595A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Intolerance Health Zyprexa PS Analgesic Drug Level Professional Above Therapeutic Blood Alcohol Increased Overdose Date:04/29/98ISR Number: 3078804-XReport Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Zyprexa PS 10 MG QD Initial or Prolonged Chest Pain Paxil SS Sk-Beecham 30 MG QD Syncope Date:04/30/98ISR Number: 3072974-5Report Type:Direct Company Report # Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dermatitis Zyprexa PS Lilly ORAL TAB; 5 MG PO Intervention to Urticaria Q HS Prevent Permanent Wellbutrin C Impairment/Damage Dexadrine C Date:04/30/98ISR Number: 3073314-8Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Generalised Zyprexa PS Lilly 10 MG QD Riperdal C Doxepin C Alprazolam C Date:05/01/98ISR Number: 3161001-7Report Type:Periodic Company Report #US9703013A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS 15 MG/ 1DAY Initial or Prolonged Delusion Health Lorazepam C Hallucination Professional Motrin C Overdose ... C Date:05/01/98ISR Number: 3161004-2Report Type:Periodic Company Report #US97030154A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS 7.5 MG/ 1 DAY Initial or Prolonged Professional Glucagon C Haldol C 24-Jun-2005 12:19 PM Page: 272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3161006-6Report Type:Periodic Company Report #US97030322A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Study Zyprexa PS 5 MG/ 4 DAY Initial or Prolonged Agitation Health Ativan C Insomnia Professional Nervousness Date:05/01/98ISR Number: 3161009-1Report Type:Periodic Company Report #US97030574A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS 100MG/ 1 Initial or Prolonged Overdose Professional Sedation Thinking Abnormal Date:05/01/98ISR Number: 3161012-1Report Type:Periodic Company Report #US97030616A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Cholecystitis Health Lithium Carbonate C Professional Ativan C Proventil C Date:05/01/98ISR Number: 3161015-7Report Type:Periodic Company Report #US97033052A Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa PS 10 MG/ 1 DAY Phosphokinase Increased Professional Lithium Carbonate C Leukocytosis Company Clonazepam C Masked Facies Representative Valproate Sodium C Muscle Rigidity Neuroleptic Malignant Syndrome Date:05/01/98ISR Number: 3161019-4Report Type:Periodic Company Report #US97033745A Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Disorder Study Zyprexa PS 10MG/ 1 DAY Hospitalization - Health Tylenol C Initial or Prolonged Professional Ibuprofen C Aspirin C Zestril C Neferex C Bumex C Milk Of Magnesia C Vistaril C 24-Jun-2005 12:19 PM Page: 273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162000-1Report Type:Periodic Company Report #US96114585A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS 7.5 MG / 1 Nervousness DAY Mellaril C Prolixin C Navane C Date:05/01/98ISR Number: 3162006-2Report Type:Periodic Company Report #US96113625A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 10 MG/1 DAY 1 WK Weight Increased Professional Lithium C Thiothixene C Date:05/01/98ISR Number: 3162008-6Report Type:Periodic Company Report #US96113655A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS 1 MON Professional Klonopin C Trimipramine C Inderal C Clozaril C Date:05/01/98ISR Number: 3162037-2Report Type:Periodic Company Report #US96114003A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Health Zyprexa PS 80 MG Professional Company Representative Date:05/01/98ISR Number: 3162040-2Report Type:Periodic Company Report #US96114006A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Consumer Zyprexa PS 5 MG / 1 DAY 10 DAY Tegretol C Cortef C Klonopin C Progrestine C Date:05/01/98ISR Number: 3162043-8Report Type:Periodic Company Report #US96114087A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS 10 MG/ 1 DAY 9 DAY Professional Sertraline C Albuterol C Iron C Valproic Acid C 24-Jun-2005 12:19 PM Page: 274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162045-1Report Type:Periodic Company Report #US96114123A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperventilation Health Zyprexa PS Tremor Professional Date:05/01/98ISR Number: 3162048-7Report Type:Periodic Company Report #US96114153A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 10 MG / 1 DAY Urinary Incontinence Professional Cyclosporin A C Mevacor C Thorazine C Prednisone C Imuran C Date:05/01/98ISR Number: 3162050-5Report Type:Periodic Company Report #US96114273A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Keratoconjunctivitis Consumer Zyprexa PS 10 MG / 1 DAY 3 WK Sicca Health Hydroxyzine C Thinking Abnormal Professional Alprazolam C Visual Disturbance Naproxen C Date:05/01/98ISR Number: 3162052-9Report Type:Periodic Company Report #US96114330A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Study Zyprexa PS 20 MG / 1 DAY Health Ativan C Professional Date:05/01/98ISR Number: 3162053-0Report Type:Periodic Company Report #US96112095A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS 10 MG / 1 DAY 3 DAY Muscle Twitching Professional Stelazine C Company Representative Date:05/01/98ISR Number: 3162054-2Report Type:Periodic Company Report #US96112407A Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS 10 MG / 1 DAY 10 DAY Dizziness Professional Visual Disturbance 24-Jun-2005 12:19 PM Page: 275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162057-8Report Type:Periodic Company Report #US96112410A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS 270 MG / 1 Professional DAY Risperdal C Depakote C Date:05/01/98ISR Number: 3162059-1Report Type:Periodic Company Report #US96112464A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa PS 10 MG / 1 DAY 1 WK Tongue Disorder Risperdal C Paxil C Klonopin C Date:05/01/98ISR Number: 3162061-XReport Type:Periodic Company Report #US96112512A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 10 MG / 1 DAY 1 MON Pain Professional Depakote C Ativan C Sertraline C Hydrochlorothiazide C Date:05/01/98ISR Number: 3162063-3Report Type:Periodic Company Report #US96112575A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Maculo-Papular Health Zyprexa PS Professional Benadryl C Date:05/01/98ISR Number: 3162064-5Report Type:Periodic Company Report #US96112779A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depersonalisation Consumer Zyprexa PS 10 MG /1 DAY 11 DAY Increased Appetite Prozac SS Oedema Peripheral Benadryl C Pruritus Date:05/01/98ISR Number: 3162065-7Report Type:Periodic Company Report #US96113013A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS 15 MG / 1 DAY Hallucination Health Klonopin C Professional Risperdal C 24-Jun-2005 12:19 PM Page: 276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162066-9Report Type:Periodic Company Report #US96111942A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Maculo-Papular Health Zyprexa PS 10 MG / 1 DAY 3 WK Professional Date:05/01/98ISR Number: 3162068-2Report Type:Periodic Company Report #US96111954A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS 10 MG / 1 DAY 3 WK Arthropathy Professional Haldol C Extrapyramidal Disorder Depakote C Oedema Peripheral Cogentin C Salivary Hypersecretion Lithium C Date:05/01/98ISR Number: 3162173-0Report Type:Periodic Company Report #IT96064198A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neurosis Study Zyprexa PS 10 MG Initial or Prolonged Schizophreniform Disorder Health Tavor C Professional Date:05/01/98ISR Number: 3162175-4Report Type:Periodic Company Report #US93082341A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Depression Health Synthroid C Hostility Professional Schizophreniform Disorder Date:05/01/98ISR Number: 3162176-6Report Type:Periodic Company Report #US94010550A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS 10 MG / 1 DAY Initial or Prolonged Schizophreniform Disorder Health Ativan C Professional Date:05/01/98ISR Number: 3162177-8Report Type:Periodic Company Report #US94021963A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 10 MG DAY Initial or Prolonged Health Ativan C Professional Ventolin C Lidex C Intal C 24-Jun-2005 12:19 PM Page: 277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162179-1Report Type:Periodic Company Report #US94023052A Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS 10 MG / 1 DAY Initial or Prolonged Health Cogentin C Professional Restoril C Tylenol C Date:05/01/98ISR Number: 3162180-8Report Type:Periodic Company Report #US94023565A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS 15 MG/ 1 DAY Initial or Prolonged Insomnia Health Tavist-D C Other Vomiting Professional Chloral C Tylenol Cold Extra Strength C Date:05/01/98ISR Number: 3162184-5Report Type:Periodic Company Report #US94024114A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Sedation Health Humulin R C Speech Disorder Professional Humulin Nph C Valium C Date:05/01/98ISR Number: 3162186-9Report Type:Periodic Company Report #US94042179A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Agitation Consumer Multivitamin C Injury Iron C Insomnia Ibuprofen C Mania Ativan C Schizophreniform Disorder Date:05/01/98ISR Number: 3162187-0Report Type:Periodic Company Report #US94061645A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS 5 MG/ 3 DAY Initial or Prolonged Schizophreniform Disorder Consumer Ativan C Cogentin C Date:05/01/98ISR Number: 3162188-2Report Type:Periodic Company Report #US94062668A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Study Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Schizophreniform Disorder Health Cogentin C Professional Dyazide C Lorazepam C 24-Jun-2005 12:19 PM Page: 278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162189-4Report Type:Periodic Company Report #US94062986A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Study Zyprexa PS 20 MG/ 1 DAY 3 MON Other Overdose Health Norinyl C Petechiae Professional Gemfibrozil C Pulmonary Oedema Lorazepam C Subarachnoid Haemorrhage Septra C Vomiting Date:05/01/98ISR Number: 3162190-0Report Type:Periodic Company Report #US94090043A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Hyperhidrosis Health Temazepam C Professional Lorazepam C Date:05/01/98ISR Number: 3162191-2Report Type:Periodic Company Report #US94100979A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Health Temazepam C Professional Date:05/01/98ISR Number: 3162192-4Report Type:Periodic Company Report #US94100997A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apathy Study Zyprexa PS 15 MG/ 1 DAY Hospitalization - Depression Health Initial or Prolonged Professional Date:05/01/98ISR Number: 3162193-6Report Type:Periodic Company Report #US94102017A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Schizophreniform Disorder Health Ativan C Professional Date:05/01/98ISR Number: 3162194-8Report Type:Periodic Company Report #US94123067A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Zyprexa PS 15 MG/ 1 DAY Initial or Prolonged Alcohol Intolerance Health Diarrhoea Professional Pancreatitis Pyrexia Vomiting 24-Jun-2005 12:19 PM Page: 279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162195-XReport Type:Periodic Company Report #US94123847A Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Nausea Health Lorazepam C Professional Niacinamide C Percocet C Prilosec C Ibuprofen C Promethazine C Meperidine Hydrochloride C Date:05/01/98ISR Number: 3162196-1Report Type:Periodic Company Report #US94124111A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Health Ativan C Professional Date:05/01/98ISR Number: 3162197-3Report Type:Periodic Company Report #US95041963A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematemesis Study Zyprexa PS 20 MG DAY 22 WK Haemoptysis Health Doss C Professional Tylenol C Valium C Restoril C Date:05/01/98ISR Number: 3162198-5Report Type:Periodic Company Report #US95042107A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Deficit/Hyperactivity Health Lorazepam C Disorder Professional Mania Schizophreniform Disorder Date:05/01/98ISR Number: 3162199-7Report Type:Periodic Company Report #US96120742A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS 5 MG DAY Weight Increased Maxzide (Dyazide) C Verapamil C Date:05/01/98ISR Number: 3162200-0Report Type:Periodic Company Report #US96120745A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Leukopenia Health Professional Company 24-Jun-2005 12:19 PM Page: 280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS 10 MG Florinef C Xanax C Tenormin C Prozac C Imdur C Synthroid C Premarin C Provera C Prinivil C Date:05/01/98ISR Number: 3162201-2Report Type:Periodic Company Report #US96120757A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Consumer Zyprexa PS 5 MG / 1 DAY 2 DAY Synthroid C Lithium C Restoril C Date:05/01/98ISR Number: 3162202-4Report Type:Periodic Company Report #US96120856A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Health Zyprexa PS Professional Thorazine C Date:05/01/98ISR Number: 3162203-6Report Type:Periodic Company Report #US96120871A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS 10 MG / 1 DAY 1 MON Insomnia Trifluoperazine C Nervousness Date:05/01/98ISR Number: 3162204-8Report Type:Periodic Company Report #US96120886A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Orthostatic Hypotension Health Zyprexa PS 2.5 MG / 1 Professional DAY 1 WK Ativan C Risperdal C Date:05/01/98ISR Number: 3162205-XReport Type:Periodic Company Report #US96120463A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS 5 MG/1 DAY 5 DAY Professional Monopril C Allergy Shot C 24-Jun-2005 12:19 PM Page: 281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162206-1Report Type:Periodic Company Report #US96120469A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Health Zyprexa PS 10 MG 3 WK Syncope Professional Company Representative Date:05/01/98ISR Number: 3162207-3Report Type:Periodic Company Report #US96120481A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Study Zyprexa PS 20 MG / 1 DAY Health Lorazepam C Professional Date:05/01/98ISR Number: 3162208-5Report Type:Periodic Company Report #US96120490A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Phosphokinase Increased Professional Lithium C Leukocytosis Clozaril C Psychotic Disorder Date:05/01/98ISR Number: 3162209-7Report Type:Periodic Company Report #US96120505A Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS 11.25 MG 1 DAY Professional Klonopin C Date:05/01/98ISR Number: 3162210-3Report Type:Periodic Company Report #US96120529A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS 20 MG / 1 DAY 3 WK Eye Pain Date:05/01/98ISR Number: 3162211-5Report Type:Periodic Company Report #US96115074A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Health Zyprexa PS 10 MG / 1 DAY 10 DAY Coordination Abnormal Professional Dizziness Oedema Peripheral Personality Disorder Date:05/01/98ISR Number: 3162212-7Report Type:Periodic Company Report #US96115086A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Zyprexa PS 10 MG / 1 DAY Professional Methadone C 24-Jun-2005 12:19 PM Page: 282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin C Date:05/01/98ISR Number: 3162213-9Report Type:Periodic Company Report #US96115098A Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Consumer Zyprexa PS 10 MG Hallucination Health Professional Date:05/01/98ISR Number: 3162214-0Report Type:Periodic Company Report #US96115281A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Consumer Zyprexa PS 10 MG/1 DAY 9 DAY Health Lithium C Professional Synthroid C Date:05/01/98ISR Number: 3162215-2Report Type:Periodic Company Report #US96115293A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS 5 MG/1 DAY 5 DAY Nervousness Professional Risperdal C Ativan C Synthroid C Trazodone C Date:05/01/98ISR Number: 3162216-4Report Type:Periodic Company Report #US96115350A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Study Zyprexa PS 20 MG/1 DAY Health Ativan C Professional Date:05/01/98ISR Number: 3162217-6Report Type:Periodic Company Report #US96115365A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS 5 MG / 1 DAY 2 WK Lymphadenopathy Wellbutrin C Pharyngitis Depakote C Synthroid C Cytomel C Lorazepm C Date:05/01/98ISR Number: 3162218-8Report Type:Periodic Company Report #US96115044A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Zyprexa PS Professional Risperdal C Company Representative 24-Jun-2005 12:19 PM Page: 283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162234-6Report Type:Periodic Company Report #US95063676A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Zyprexa PS 20 MG; 1 Initial or Prolonged Insomnia Health DAY Professional Date:05/01/98ISR Number: 3162235-8Report Type:Periodic Company Report #US95083082A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Study Zyprexa PS 15 MG; 1 Initial or Prolonged Lung Disorder Health DAY Professional Diabeta C Date:05/01/98ISR Number: 3162236-XReport Type:Periodic Company Report #US96020742A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS 15 MG; 1 DAY Initial or Prolonged Health Glyburide C Professional Multivitamin C Temovate C Coal Tar C Date:05/01/98ISR Number: 3162237-1Report Type:Periodic Company Report #US96066232A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Zyprexa PS 15 MG; 1 Initial or Prolonged Delusion Health DAY Hallucination Professional Insomnia Schizophreniform Disorder Date:05/01/98ISR Number: 3162238-3Report Type:Periodic Company Report #US96101057A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Zyprexa PS 20 MG; 1 Initial or Prolonged Injury Health DAY Paranoia Professional Klonopin C Psychotic Disorder Date:05/01/98ISR Number: 3162239-5Report Type:Periodic Company Report #US96102308A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 20 MG; 1 Initial or Prolonged Hostility Health DAY Professional Ativan C ... C 24-Jun-2005 12:19 PM Page: 284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162240-1Report Type:Periodic Company Report #US96103709A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Study Zyprexa PS 15 MG; 1 Initial or Prolonged Health DAY Professional Insulin C Date:05/01/98ISR Number: 3162241-3Report Type:Periodic Company Report #US96104276A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 25 MG; 1 Initial or Prolonged Hostility Health DAY Professional Klonopin C Date:05/01/98ISR Number: 3162242-5Report Type:Periodic Company Report #US96104498A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 20 MG; 1 Initial or Prolonged Delusion Health DAY Professional Feosol C Date:05/01/98ISR Number: 3162243-7Report Type:Periodic Company Report #US96104546A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 15 MG; 1 Initial or Prolonged Hallucination Health DAY Hostility Professional Ativan C Paranoia Cogentin C Chloral Hydrate C Date:05/01/98ISR Number: 3162244-9Report Type:Periodic Company Report #US96105500A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 20MG; 1 DAY Initial or Prolonged Hostility Health Cogentin C Professional Date:05/01/98ISR Number: 3162245-0Report Type:Periodic Company Report #US96105554A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Health Zyprexa PS 10 MG; 1 Aminotransferase Professional DAY Increased Procardia Xl C Blood Creatine Haldol C Phosphokinase Increased Benadryl C Hypotension 24-Jun-2005 12:19 PM Page: 285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162661-7Report Type:Periodic Company Report #US97105842A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa (Olanzapine) PS 300 MG DAY Initial or Prolonged Intentional Misuse Professional Other Syncope Company Representative Date:05/01/98ISR Number: 3162665-4Report Type:Periodic Company Report #US97112344A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Study Zyprexa (Olanzapine) PS 5 MG Health Professional Date:05/01/98ISR Number: 3162667-8Report Type:Periodic Company Report #US97112422A Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa (Olanzapine) PS 10MG/ 1 DAY Life-Threatening Health Lozepam C Professional Busipirone C Levothyroxine Sodium C Digoxin C Trazodone C Tylenol C Bacitracin C Date:05/01/98ISR Number: 3162671-XReport Type:Periodic Company Report #US97112431A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS 400 MG/ 1 DAY 1 DAY Initial or Prolonged Liver Function Test Professional Sedation Tachycardia Date:05/01/98ISR Number: 3162674-5Report Type:Periodic Company Report #US97112731A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Health Phazyme C Professional Ducosate C Nortriptyline C Lanoxin C Aspirin C Buspar C Hydroxyzine C Enulose C Vitamin E C Ibuprofen C Acetaminophen C Milk Of Magnesia C Zithromax C Cipro C 24-Jun-2005 12:19 PM Page: 286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax C Date:05/01/98ISR Number: 3162678-2Report Type:Periodic Company Report #US97113046A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa (Olanzapine) PS 1 YR Initial or Prolonged Diabetic Ketoacidosis Professional Hyperglycaemia Thirst Vomiting Date:05/01/98ISR Number: 3162682-4Report Type:Periodic Company Report #US97113076A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Professional Date:05/01/98ISR Number: 3162684-8Report Type:Periodic Company Report #US97113817A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 7.5 MG/ 1 DAY Initial or Prolonged Phosphokinase Increased Professional Thioridazine C Other Blood Creatinine Company Haldol C Increased Representative Valproic Acid C Blood Urea Increased Cardizem C Confusional State Clonidine C Hyperhidrosis Lorazepam C Hypertension Hypertonia Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:05/01/98ISR Number: 3162686-1Report Type:Periodic Company Report #US97114054A Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Professional Trihexyphenidyl C Other Date:05/01/98ISR Number: 3162689-7Report Type:Periodic Company Report #US97114108A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Phosphokinase Increased Professional Lithium Carbonate C Hypertension Ambien C Hypertonia Muscle Rigidity Tachycardia 24-Jun-2005 12:19 PM Page: 287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3162699-XReport Type:Periodic Company Report #US97114123A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Aminotransferase Professional Haldol C Increased Buspar C Cholelithiasis Depakote C Dysuria Lactulose C Hypotension Synthroid C Stupor Thrombocytopenia Date:05/01/98ISR Number: 3162703-9Report Type:Periodic Company Report #US97114372A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY 3 MON Initial or Prolonged Diabetes Mellitus Professional Lorazepam C Hyperglycaemia Date:05/01/98ISR Number: 3162707-6Report Type:Periodic Company Report #US97120121A Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Hospitalization - Pneumonia Health Zantac C Initial or Prolonged Tachycardia Professional Propulsid C Haldol C Date:05/01/98ISR Number: 3163025-2Report Type:Periodic Company Report #US_980301062 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Zyprexa (Olanzapine) PS 5 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Ecotrin C Multivitamin C Lasix C Kaon-Cl C Synthroid C Remeron C Metoprolol C Ibuprofen C Apap C Keflex C Date:05/01/98ISR Number: 3163027-6Report Type:Periodic Company Report #US_980301048 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Hepatitis A Professional Depakote C Urine Abnormality Company Vomiting Representative 24-Jun-2005 12:19 PM Page: 288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3163028-8Report Type:Periodic Company Report #US_980301026 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Health Zyprexa (Olanzapine) PS Hepatitis Professional Pyrexia Date:05/01/98ISR Number: 3163029-XReport Type:Periodic Company Report #US_980300927 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Health Professional Date:05/01/98ISR Number: 3163030-6Report Type:Periodic Company Report #US_980300922 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Zyprexa (Olanzapine) PS 15 MG/ 1 DAY 3 WK Initial or Prolonged Leukopenia Clozaril C Date:05/01/98ISR Number: 3163099-9Report Type:Periodic Company Report #US97105779A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Injury Health Aspirin C Disability Professional Isoptin C Multivitamin C Date:05/01/98ISR Number: 3163103-8Report Type:Periodic Company Report #US97104534A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Health Prolixin C Professional Atarax C Date:05/01/98ISR Number: 3163105-1Report Type:Periodic Company Report #US97104924A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 30 MG/ 1 DAY Initial or Prolonged Professional Synthroid C Other Dilantin C Risperdal C Lithium C Date:05/01/98ISR Number: 3163109-9Report Type:Periodic Company Report #US97103961A Age:63 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Creatine 24-Jun-2005 12:19 PM Page: 289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Delirium Hallucination Leukocytosis Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Health Zyprexa PS 5 MG/ 1 DAY Orthostatic Hypotension Professional Zoloft C Paranoia Klonopin C Sedation Risperdal C Stupor Ect C Thinking Abnormal Tremor Urinary Incontinence Urinary Retention Date:05/01/98ISR Number: 3163112-9Report Type:Periodic Company Report #US97103394A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Study Zyprexa PS 5 MG/ 1 DAY Hospitalization - Dehydration Health Allegra C Initial or Prolonged Hypernatraemia Professional Synthroid C Lung Disorder Lorazepam C Pneumonia Pyrexia Date:05/01/98ISR Number: 3163145-2Report Type:Periodic Company Report #US97102356A Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa PS 5 MG Initial or Prolonged Pyrexia Health Bactrim C Professional Date:05/01/98ISR Number: 3163146-4Report Type:Periodic Company Report #US97102407A Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Study Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Pyrexia Health Zantac C Tachycardia Professional Ativan C Vomiting Demerol C Date:05/01/98ISR Number: 3163152-XReport Type:Periodic Company Report #US97101894A Age:40 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aspartate Initial or Prolonged Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Hormone Level Abnormal Hyponatraemia Injury Leukocytosis Myopathy 24-Jun-2005 12:19 PM Page: 290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pneumonia Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS 10 MG/ 1 DAY 5 WK Thinking Abnormal Professional Clozapine C Date:05/01/98ISR Number: 3163154-3Report Type:Periodic Company Report #US97101897A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Study Zyprexa PS 10 MG DAY Initial or Prolonged Apathy Health Trazodone C Other Confusional State Professional Risperidone C Hallucination Docusate Sodium C Salivary Hypersecretion Levobunolol C Sedation Depakote C Speech Disorder Tylenol C Stupor Date:05/01/98ISR Number: 3163156-7Report Type:Periodic Company Report #US97102089A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 20 MG Initial or Prolonged Health Advil C Professional Date:05/01/98ISR Number: 3163158-0Report Type:Periodic Company Report #US97101204A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS 10 MG/ 1 DAY 10 MON Initial or Prolonged Hyperglycaemia Professional Lamictal C Lithium C Date:05/01/98ISR Number: 3163162-2Report Type:Periodic Company Report #US97101570A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS 15 MG/ 1 DAY Hospitalization - Health Initial or Prolonged Professional Date:05/01/98ISR Number: 3163168-3Report Type:Periodic Company Report #US98015710A Age:41 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Hypertonia Hyperventilation Leukocytosis Liver Function Test Abnormal Neuroleptic Malignant Syndrome 24-Jun-2005 12:19 PM Page: 291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Tachycardia Tremor Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 20 MG/ 1 DAY Professional Zoloft C Depakote C Buspar C Pepcid C Lithium C Date:05/01/98ISR Number: 3163171-3Report Type:Periodic Company Report #US98015683A Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Zyprexa PS 15 MG DAY Health Cipro C Professional Prilosec C Ferrous Sulfate C Docusate C Date:05/01/98ISR Number: 3163176-2Report Type:Periodic Company Report #US98015059A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa PS 15 MG/ 1 DAY Professional Depakote C Buspar C Date:05/01/98ISR Number: 3163190-7Report Type:Periodic Company Report #US98015005A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Study Zyprexa PS 5 MG/ 1 DAY Haemorrhage Health Lithium Carbonate C Professional Tylenol Cold And Flu (Cotylenol) C Ketoprofen C Tums C Date:05/01/98ISR Number: 3163235-4Report Type:Periodic Company Report #US98014711A Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hypersensitivity Study Zyprexa PS 5 MG/ 1 DAY Health Zocor C Professional Cipro (Ciprofloxacin Hydrochloride) C Multivitamins C Milk Of Magnesia (Magnesium Hydroxide) C Vistaril (Hydroxyzine Embonate) C Bactrim Ds C Senokot (Senna Fruit) C 24-Jun-2005 12:19 PM Page: 292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medrol Dosepak (Methylprednisolone) C Bisacodyl C Bactrim C Date:05/01/98ISR Number: 3163236-6Report Type:Periodic Company Report #US98014534A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Literature Zyprexa PS 135 MG Initial or Prolonged Sedation Health Suicide Attempt Professional Date:05/01/98ISR Number: 3163238-XReport Type:Periodic Company Report #US98014507A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Literature Zyprexa PS Initial or Prolonged Speech Disorder Health Amitriptyline C Suicide Attempt Professional Klonopin Thinking Abnormal (Clonazepam) C Vomiting Hydromorphone C Effexor (Venlafaxine Hydrochloride) C Date:05/01/98ISR Number: 3163240-8Report Type:Periodic Company Report #US98014498A Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Literature Zyprexa PS Initial or Prolonged Sedation Health Professional Date:05/01/98ISR Number: 3163243-3Report Type:Periodic Company Report #US98014228A Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Zyprexa PS 5 MG/ 1 DAY Health Lasix C Professional Cimetidine C Multivitamins C Dulcolax (Bisacodyl) C Fleet Enema C Milk Of Magnesia (Magnesium Hydrochloride) C Tylenol (Paracetamol) C Erythromycin C Apap (Paracetamol) C 24-Jun-2005 12:19 PM Page: 293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3163245-7Report Type:Periodic Company Report #US98013982A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Zyprexa PS 15 MG/ DAY Initial or Prolonged Health Depakote (Valproate Other Professional Sodium) C Ativan (Lorazepam) C Tylenol (Paracetamol) C Date:05/01/98ISR Number: 3163249-4Report Type:Periodic Company Report #US98013745A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS Initial or Prolonged Sedation Professional Date:05/01/98ISR Number: 3163817-XReport Type:Periodic Company Report #US-980300662 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crying Study Zyprexa PS 15 MG/ 1 DAY Initial or Prolonged Feeling Of Despair Health Prozac C Hallucination, Auditory Professional Cogentin C Date:05/01/98ISR Number: 3163819-3Report Type:Periodic Company Report #US_980300658 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Olanzapine PS 10 MG/DAY Phosphokinase Increased Professional Valproic Acid C Dyskinesia Other Hyperhidrosis Hypertonia Neuroleptic Malignant Syndrome Pyrexia Stupor Tachycardia Urinary Incontinence Date:05/01/98ISR Number: 3163820-XReport Type:Periodic Company Report #US97015641A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 10MG 1 DAY 2 MON Initial or Prolonged Hostility Professional Lithium Carbonate C Urinary Retention Company White Blood Cell Disorder Representative Date:05/01/98ISR Number: 3163825-9Report Type:Periodic Company Report #US97015245A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Other Dystonia Health Professional 24-Jun-2005 12:19 PM Page: 294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10MG DAY Thorazine C Date:05/01/98ISR Number: 3163831-4Report Type:Periodic Company Report #US97013610A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 5MG 1 DAY Initial or Prolonged Depression Professional Sertraline C Electrolyte Depletion Phenytoin C Muscle Twitching Trifluoperazine C Premarin C Provera C Tenormin C Aspirin C Date:05/01/98ISR Number: 3163835-1Report Type:Periodic Company Report #US97014042A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 5MG 4 WK Initial or Prolonged Depression Professional Company Representative Date:05/01/98ISR Number: 3163838-7Report Type:Periodic Company Report #US97012239A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa (Olanzapine) PS 10MG 1 DAY Initial or Prolonged Confusional State Health Congentin C Drug Dependence Professional Ativan C Date:05/01/98ISR Number: 3163840-5Report Type:Periodic Company Report #US96124594A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Zyprexa (Olanzapine) PS Initial or Prolonged Abnormal Professional Levothroxine C Myalgia Company Pyrexia Representative Vomiting White Blood Cell Disorder Date:05/01/98ISR Number: 3163843-0Report Type:Periodic Company Report #US96124603A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS Initial or Prolonged Syndrome Professional Risperdal C 24-Jun-2005 12:19 PM Page: 295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3164285-4Report Type:Periodic Company Report #US97041966A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stupor Health Zyprexa PS 20MG 1 DAY 2 WK Initial or Prolonged Professional Haldol C Date:05/01/98ISR Number: 3164286-6Report Type:Periodic Company Report #US97040874A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa (Olanzapine) PS 20MG 1 DAY Initial or Prolonged Coma Professional Xanax C Dyspnoea Company Representative Date:05/01/98ISR Number: 3164287-8Report Type:Periodic Company Report #US97040070A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 20MG 1 DAY Initial or Prolonged Emotional Disorder Health Synthroid C Hallucination Professional Vitamin E C Personality Disorder Thinking Abnormal Date:05/01/98ISR Number: 3164288-XReport Type:Periodic Company Report #US97036136A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS 20MG 1 DAY Initial or Prolonged Health Lithium C Professional Date:05/01/98ISR Number: 3164289-1Report Type:Periodic Company Report #US97034282A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS Initial or Prolonged Confusional State Professional Required Dermatitis Intervention to Hallucination Prevent Permanent Intentional Misuse Impairment/Damage Pyrexia Sedation Tachycardia Date:05/01/98ISR Number: 3164422-1Report Type:Periodic Company Report #US98013343A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Study Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Hospitalization - Health Amantadine C Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3164425-7Report Type:Periodic Company Report #US98011738A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa (Olanzapine) PS 10MG Initial or Prolonged Health Professional Date:05/01/98ISR Number: 3164428-2Report Type:Periodic Company Report #US98011948A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypoventilation Health Brevital Professional (Methohexital Sodium) PS Zyprexa (Olanzapine) SS Date:05/01/98ISR Number: 3164430-0Report Type:Periodic Company Report #US98011183A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Study Zyprexa (Olanzapine) PS 5MG/ 1DAY Hospitalization - Deep Vein Thrombosis Health Ultram C Initial or Prolonged Professional Tylenol C Date:05/01/98ISR Number: 3164433-6Report Type:Periodic Company Report #US98011078A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthropathy Health Zyprexa (Olanzapine) PS 15MG/1 DAY Blood Creatine Professional Phosphokinase Increased Company Hyperhidrosis Representative Hypertension Hypertonia Leukocytosis Liver Function Test Abnormal Muscle Twitching Myalgia Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:05/01/98ISR Number: 3164445-2Report Type:Periodic Company Report #US96105749A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 10 MG; 1 Initial or Prolonged Hostility Health DAY Professional Cogentin C 24-Jun-2005 12:19 PM Page: 297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3164449-XReport Type:Periodic Company Report #US96110727A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS 10 MG; 1 Ketoacidosis Professional DAY Pulmonary Oedema Paxil C Depakote C Klonopin C Risperdal C Date:05/01/98ISR Number: 3164457-9Report Type:Periodic Company Report #US97042920A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Health Zyprexa PS 20 MG 1 DAY Initial or Prolonged Professional Prozac C Coumadin C Congentin C Klonopin C Desyrel C Date:05/01/98ISR Number: 3164462-2Report Type:Periodic Company Report #US97043835A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Health Other Professional Date:05/01/98ISR Number: 3164466-XReport Type:Periodic Company Report #US97044804A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS 150 MG 1 DAY Initial or Prolonged Intentional Misuse Professional Tegretol C Sedation Date:05/01/98ISR Number: 3164469-5Report Type:Periodic Company Report #US97044828A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 15 MG 1 DAY Initial or Prolonged Alcohol Intolerance Health Prozac C Confusional State Professional Ativan C Injury Date:05/01/98ISR Number: 3164472-5Report Type:Periodic Company Report #US97045497A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Professional Lithium C Depakote C 24-Jun-2005 12:19 PM Page: 298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3164476-2Report Type:Periodic Company Report #US97050499A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 20MG DAY Initial or Prolonged Delusion Health Lithium C Hostility Professional Muscle Twitching Personality Disorder Thinking Abnormal Date:05/01/98ISR Number: 3164478-6Report Type:Periodic Company Report #US97050853A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa PS 6 MON Initial or Prolonged Increased Professional Imipramine C Hyperglycaemia Company Depakote C Sedation Representative Dexdrine C Date:05/01/98ISR Number: 3164596-2Report Type:Periodic Company Report #US98023259A Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Zyprexa PS 2.5 MG/1 DAY 6 DAY Hypokinesia Professional Sinemet C Date:05/01/98ISR Number: 3164599-8Report Type:Periodic Company Report #US98023499A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Prozac (Fluoxetine Health Hydrochloride) PS Professional Zyprexa (Olanzapine) SS Date:05/01/98ISR Number: 3164605-0Report Type:Periodic Company Report #US98030394A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Atrial Fibrillation Professional Coumadin C Hypertonia Other Lanoxin C Neuroleptic Malignant Calan Sr C Syndrome Valium C Pyrexia Date:05/01/98ISR Number: 3164609-8Report Type:Periodic Company Report #US98030340A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Hallucination Health Keflex C Professional 24-Jun-2005 12:19 PM Page: 299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3164612-8Report Type:Periodic Company Report #US98030136A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa PS 5 MG/1 DAY Initial or Prolonged Professional Luvox C Company Knolopin C Representative Date:05/01/98ISR Number: 3164617-7Report Type:Periodic Company Report #US98030073A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zyprexa PS 5 MG Life-Threatening Faecaloma Professional Risperdal C Hospitalization - Gastrointestinal Sudafed C Initial or Prolonged Carcinoma Ativan C Jaundice Cholestatic Peri-Colace C Date:05/01/98ISR Number: 3164620-7Report Type:Periodic Company Report #US98025575A Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Zyprexa PS 5 MG/1 DAY Life-Threatening Congestive Health Aspirin C Hospitalization - Pneumonia Professional Nitroglycerin C Initial or Prolonged Rales Tylenol C Lasix C Ceftin C Date:05/01/98ISR Number: 3164625-6Report Type:Periodic Company Report #US98024867A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS 5 MG/1 DAY Initial or Prolonged Professional Xanax C Buspar C Nortriptyline C Propranolol C Date:05/01/98ISR Number: 3164627-XReport Type:Periodic Company Report #US98024669A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS Syndrome Professional Company Representative Date:05/01/98ISR Number: 3164628-1Report Type:Periodic Company Report #US98023757A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa PS 10 MG/2 DAY Initial or Prolonged Health Doxepin C Professional Paxil C Cogentin C 24-Jun-2005 12:19 PM Page: 300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3164629-3Report Type:Periodic Company Report #US98023742A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Zyprexa PS 10 MG/1 DAY Initial or Prolonged Psychotic Disorder Professional Clarithromycin C Other Trazodone C Metronidazole C Vitamin E C Date:05/01/98ISR Number: 3164631-1Report Type:Periodic Company Report #US98023580A Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Study Zyprexa PS 2.5 MG.1 AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Zantac C Aspirin C Vasotec C Insulin C Sinemet C Date:05/01/98ISR Number: 3164633-5Report Type:Periodic Company Report #US98023520A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS 40 MG OTHER 4 WK Dry Mouth Health Mellaril C Intentional Misuse Professional Phenergan C Nervousness Neurontin C Thinking Abnormal Fioricet C Date:05/01/98ISR Number: 3164634-7Report Type:Periodic Company Report #US98023517A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS 10 MG/1 DAY Professional Haldol C Date:05/01/98ISR Number: 3166216-XReport Type:Periodic Company Report #US97060658A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Libido Increased Study Zyprexa PS 20 MG/1 DAY Initial or Prolonged Mania Health Lithobid (Lithium Paranoia Professional Carbonate) C Personality Disorder Multivitamin C Date:05/01/98ISR Number: 3166219-5Report Type:Periodic Company Report #US97060562A Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Health Verapamil C Professional Peri-Colace C Tylenol C Coumadin C 24-Jun-2005 12:19 PM Page: 301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3166223-7Report Type:Periodic Company Report #US97060070A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Diabetic Ketoacidosis Health Clozaril C Hyperglycaemia Professional Depakote C Paraesthesia Pollakiuria Thirst Vomiting Date:05/01/98ISR Number: 3166228-6Report Type:Periodic Company Report #US97055761A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS 5 MG DAY Initial or Prolonged Sedation Professional Lasix C Potassium C Glyburide C Glucophage C Digoxin C Asa C Zocor C Magnesium C Cogentin C Prolixin C Ferrous Sulfate C Captopril C Date:05/01/98ISR Number: 3166231-6Report Type:Periodic Company Report #US97055542A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Dizziness Catpres C Dyspnoea Tenormin C Hostility Norvasc C Leukocytosis Personality Disorder Tremor Date:05/01/98ISR Number: 3166233-XReport Type:Periodic Company Report #US97055416A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 20 MG DAY Initial or Prolonged Hallucination Health Lithium C Hostility Professional Sleep Disorder Thinking Abnormal Date:05/01/98ISR Number: 3166256-0Report Type:Periodic Company Report #US97070604A Age:60 YR Gender:Female I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Diabetic Ketoacidosis 24-Jun-2005 12:19 PM Page: 302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glaucoma Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa PS 5 MG / 1 DAY Health Glyburide C Professional Synthroid C Coumadin C Lithium C Zantac (Ranitidine Hydrochloride) C Date:05/01/98ISR Number: 3166257-2Report Type:Periodic Company Report #US97070175A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 10 MG DAY Initial or Prolonged Health Professional Date:05/01/98ISR Number: 3166258-4Report Type:Periodic Company Report #US97070172A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS 20 MG DAY Initial or Prolonged Health Professional Date:05/01/98ISR Number: 3166259-6Report Type:Periodic Company Report #US97065620A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS 20 MG / 1 Initial or Prolonged Diabetic Ketoacidosis Professional DAY 3 MON Hyperglycaemia Company Representative Date:05/01/98ISR Number: 3166260-2Report Type:Periodic Company Report #US97065605A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS 10 MG / 1 Initial or Prolonged Anxiety Health DAY Injury Professional Ativan C Sleep Disorder Date:05/01/98ISR Number: 3166261-4Report Type:Periodic Company Report #US97065374A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Consumer Zyprexa PS Initial or Prolonged Personality Disorder 24-Jun-2005 12:19 PM Page: 303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3166262-6Report Type:Periodic Company Report #US97064390A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS 150 MG Initial or Prolonged Intentional Misuse Professional Myalgia Company Representative Date:05/01/98ISR Number: 3166263-8Report Type:Periodic Company Report #US97064384A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Study Zyprexa PS Initial or Prolonged Health Cogentin C Professional Date:05/01/98ISR Number: 3166264-XReport Type:Periodic Company Report #US97064351A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS 20 MG / 1 Initial or Prolonged Delusion Professional DAY Emotional Disorder Lithium C Paranoia Personality Disorder Thinking Abnormal Date:05/01/98ISR Number: 3166265-1Report Type:Periodic Company Report #US97064333A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 20 MG / 1 Initial or Prolonged Hostility Health DAY Paranoia Professional Zantac C Personality Disorder Date:05/01/98ISR Number: 3166266-3Report Type:Periodic Company Report #US97064069A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 10 MG 2 MON Initial or Prolonged Gastrointestinal Professional Serzone C Haemorrhage Company Hyponatraemia Representative Thirst Date:05/01/98ISR Number: 3166267-5Report Type:Periodic Company Report #US97064027A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Zyprexa PS 5 MG / 1 DAY 3 WK Headache Professional Prozac C Oedema Peripheral Klonopin C 24-Jun-2005 12:19 PM Page: 304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3166268-7Report Type:Periodic Company Report #US97063814A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS 20 MG / 1 Initial or Prolonged Increased Appetite Health DAY Other Insomnia Professional Lithium C Nervousness Ativan (Lorazepam) C Thinking Abnormal Thirst Date:05/01/98ISR Number: 3166269-9Report Type:Periodic Company Report #US97063760A Age:84 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Zyprexa PS Initial or Prolonged Pyrexia Health Urinary Tract Infection Professional Date:05/01/98ISR Number: 3166270-5Report Type:Periodic Company Report #US97062896A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS 400 MG DAY 1 DAY Initial or Prolonged Pharyngitis Professional Sedation Speech Disorder Tongue Oedema Date:05/01/98ISR Number: 3166271-7Report Type:Periodic Company Report #US97062563A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS 15 MG / 1 DAY Initial or Prolonged Professional Clonazepam C Date:05/01/98ISR Number: 3166272-9Report Type:Periodic Company Report #US97062497A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS 10 MG / 1 DAY Initial or Prolonged Diabetic Ketoacidosis Professional Carbamazepine C Other Hyperglycaemia Sertraline C Date:05/01/98ISR Number: 3166273-0Report Type:Periodic Company Report #US97062152A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Zyprexa PS 10 MG / 1 Required Professional DAY Intervention to Haldol C Prevent Permanent Norvasc C Impairment/Damage Lotensin C Urecholine C Restoril C Glucotrol C Digoxin C 24-Jun-2005 12:19 PM Page: 305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3166863-5Report Type:Periodic Company Report #US97084498A Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Cellulitis Health Multivitamins C Delirium Professional Peri-Colace C Dermatitis Dulcolax (Bisacodyl) C Eye Haemorrhage Lactulose C Oedema Pain Pyrexia Date:05/01/98ISR Number: 3166866-0Report Type:Periodic Company Report #US97084135A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa (Olanzapine) PS 25 MG/ 1 DAY 2 MON Initial or Prolonged Intentional Misuse Professional Depakote C Ketoacidosis Klonopin C Polyuria Thirst Date:05/01/98ISR Number: 3166869-6Report Type:Periodic Company Report #US97084039A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Health Lithium Carbonate C Professional Risperdal (Risperidone) C Ativan (Lorazepam) C Date:05/01/98ISR Number: 3166871-4Report Type:Periodic Company Report #US97083601A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa (Olanzapine) PS 15 MG Initial or Prolonged Gait Disturbance Professional Paxil C Company Clonapin C Representative Buspar C Date:05/01/98ISR Number: 3166875-1Report Type:Periodic Company Report #US97083793A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Zyprexa (Olanzapine) PS 6 MON Initial or Prolonged Professional Dilantin C Company Depakote C Representative Tegrestol C Date:05/01/98ISR Number: 3166878-7Report Type:Periodic Company Report #US97083556A Age:67 YR Gender:Female I/FU:I Outcome PT Hospitalization - Apnoea Initial or Prolonged Dyskinesia 24-Jun-2005 12:19 PM Page: 306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Face Oedema Stupor Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Professional Vitamin E C Benztropine C Date:05/01/98ISR Number: 3166880-5Report Type:Periodic Company Report #US97082704A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Disorder Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Eye Haemorrhage Health Calcium Carbonate C Professional Colace C Pred-Forte C Timoptic C Ecotrin C Phospholine-Iodide C Dulcolax C Date:05/01/98ISR Number: 3166884-2Report Type:Periodic Company Report #US97082809A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 10 DAY Initial or Prolonged Convulsion Professional Paxil C Cogentin C Synthroid C Date:05/01/98ISR Number: 3166886-6Report Type:Periodic Company Report #US97082602A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Zyprexa (Olanzapine) PS 5 MG/ 2 DAY Hospitalization - Dyspnoea Professional Clonazepam C Initial or Prolonged Pyrexia Company Tachycardia Representative Date:05/01/98ISR Number: 3166889-1Report Type:Periodic Company Report #US97080952A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Health Dilantin C Other Professional Enalapril C Digoxin C Cefazolin C Levofloxacin C Demerol C Date:05/01/98ISR Number: 3166890-8Report Type:Periodic Company Report #US97080964A Age:70 YR Gender:Female I/FU:I Outcome PT Hospitalization - Convulsion Initial or Prolonged Respiratory Disorder 24-Jun-2005 12:19 PM Page: 307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stupor Tachycardia Report Source Product Role Manufacturer Route Dose Duration Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Health Proventil C Professional Atrovent C Date:05/01/98ISR Number: 3167025-8Report Type:Periodic Company Report #US97081306A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Euphoric Mood Study Zyprexa PS 10 MG/DAY Initial or Prolonged Insomnia Health Nervousness Professional Thinking Abnormal Date:05/01/98ISR Number: 3167030-1Report Type:Periodic Company Report #US97074810A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Study Zyprexa PS 10 MG/DAY Initial or Prolonged Health Professional Date:05/01/98ISR Number: 3167034-9Report Type:Periodic Company Report #US97074819A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS ORAL 30 MG/ 1 DAY Initial or Prolonged Blood Creatine Professional Paxil C Phosphokinase Increased Synthroid C Confusional State Delirium Hyperhidrosis Hypertension Intentional Misuse Tachycardia Urinary Incontinence Date:05/01/98ISR Number: 3167037-4Report Type:Periodic Company Report #US97074846A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS 10 MG/DAY Initial or Prolonged Ecchymosis Health Calcium Carbonate C Pyrexia Professional Colace C Tachycardia Pred-Forte C Timoptic C Date:05/01/98ISR Number: 3167428-1Report Type:Periodic Company Report #US97100151A Age:75 YR Gender:Male I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Delirium Other Pyrexia 24-Jun-2005 12:19 PM Page: 308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 5 MG/1 DAY 2 DAY Professional Trazodone C Company Tegretol C Representative Xanax C Date:05/01/98ISR Number: 3167430-XReport Type:Periodic Company Report #US97095431A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Zyprexa PS 10 MG/1 DAY Hypotension Professional Sedation Syncope Date:05/01/98ISR Number: 3167431-1Report Type:Periodic Company Report #US97094585A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS 20 MG DAY 4 MON Initial or Prolonged Phosphokinase Increased Professional Coma Company Delirium Representative Hyponatraemia Neuroleptic Malignant Syndrome Pyrexia Thinking Abnormal Date:05/01/98ISR Number: 3167433-5Report Type:Periodic Company Report #US97094222A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS 10 MG/1 DAY 3 MON Initial or Prolonged Hyperglycaemia Professional Synthroid C Thinking Abnormal Haloperidol C Date:05/01/98ISR Number: 3167435-9Report Type:Periodic Company Report #US97093700A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Zyprexa PS 5 MG/1 DAY Initial or Prolonged Hypertension Clonazepam C Tongue Oedema Effexor C Wellbutrin C Diazepam C Pravachol C Levothyroxine C K-Dur C Toprol Xl C Furosemide C Amaryl C 24-Jun-2005 12:19 PM Page: 309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3167437-2Report Type:Periodic Company Report #US97093754A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS 10 MG/1 DAY Initial or Prolonged Hyperglycaemia Professional Haldol C Hyperlipidaemia Company Paxil C Nausea Representative Oesophagitis Polyuria Tachycardia Thirst Vomiting Weight Increased Date:05/01/98ISR Number: 3167439-6Report Type:Periodic Company Report #US97093190A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Menorrhagia Consumer Zyprexa PS 5 MG/1 DAY 3 MON Initial or Prolonged Health Klonopin C Professional Date:05/01/98ISR Number: 3167440-2Report Type:Periodic Company Report #US97092461A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 20 MG/1 DAY Initial or Prolonged Drug Dependence Health Valium C Professional Date:05/01/98ISR Number: 3167441-4Report Type:Periodic Company Report #US97092452A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS 15 MG/1 DAY Initial or Prolonged Health Valium C Professional Prozac C Salsalate C Benazepril Hydrochloride C Date:05/01/98ISR Number: 3167442-6Report Type:Periodic Company Report #US97092296A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS 10 MG/1 DAY Initial or Prolonged Hallucination Health Professional Date:05/01/98ISR Number: 3167443-8Report Type:Periodic Company Report #US97091330A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Diabetes Mellitus Health Initial or Prolonged Hyperglycaemia Professional Thirst Company 24-Jun-2005 12:19 PM Page: 310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS 2 DAY Date:05/01/98ISR Number: 3167445-1Report Type:Periodic Company Report #US97090373A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 20 MG/1 DAY Initial or Prolonged Hostility Health Mania Professional Paranoia Psychotic Disorder Date:05/01/98ISR Number: 3167447-5Report Type:Periodic Company Report #US97085167A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Zyprexa PS 10 MG/1 DAY Initial or Prolonged Oedema Health Vitamin B12 C Professional K-Dur C Artificial Tears C Milk Of Magnesia C Date:05/01/98ISR Number: 3167448-7Report Type:Periodic Company Report #US97084792A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS Initial or Prolonged Drug Ineffective Professional Company Representative Date:05/01/98ISR Number: 3167450-5Report Type:Periodic Company Report #US-980300184 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Study Olanzapine PS 15 MG/1 DAY Initial or Prolonged Health Lithium C Professional Ativan C Ibuprofen C Date:05/01/98ISR Number: 3167451-7Report Type:Periodic Company Report #US_980300179 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Study Olanzapine PS 5MG/1 DAY Health Professional 24-Jun-2005 12:19 PM Page: 311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3167453-0Report Type:Periodic Company Report #US-980300120 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 5 MG/1 DAY Health Lasix C Professional Cimetidine C Multivitamin C Dulocalax C Fleet Enema C Milk Of Magnesia C Tylenol (Paracetamol) C Erythromycin C Acetaminophen C Date:05/01/98ISR Number: 3167460-8Report Type:Periodic Company Report #US97023691A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Study Zyprexa PS 6 DSG FORM/1 Euphoric Mood Health DAY Insomnia Professional Colace C Thinking Abnormal Tylenol C Date:05/01/98ISR Number: 3167461-XReport Type:Periodic Company Report #US97023502A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS 20 MG/1 DAY Initial or Prolonged Hostility Health Lorazepam C Libido Increased Professional Triamcinolone C Nervousness Personality Disorder Speech Disorder Date:05/01/98ISR Number: 3167462-1Report Type:Periodic Company Report #US97022638A Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS 15 MG DAY Initial or Prolonged Polyuria Professional Amlodipine C Thirst Furosemide C Weight Increased Lasix C Norvasc C Date:05/01/98ISR Number: 3167464-5Report Type:Periodic Company Report #US97022176A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 15 MG / 1 DAY Initial or Prolonged Professional Other 24-Jun-2005 12:19 PM Page: 312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3167466-9Report Type:Periodic Company Report #US97016292A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 5 MG/1 DAY Initial or Prolonged Professional Propranolol C Other Mellaril C Tegretol C Oxazepam C Date:05/01/98ISR Number: 3167467-0Report Type:Periodic Company Report #US97021276A Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Consumer Zyprexa PS 5 MG/1 DAY 6 WK Initial or Prolonged Pyrexia Nicardipine C Isosorbide C Bumex C Allopurinol C Digoxin C Lorazepam C Date:05/01/98ISR Number: 3167468-2Report Type:Periodic Company Report #US96121534A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Study Zyprexa PS Health Lorazepam C Professional Date:05/01/98ISR Number: 3167469-4Report Type:Periodic Company Report #US96121930A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 5 MG/1 DAY Initial or Prolonged Professional Amitriptyline C Ditropan C Verapamil C Ativan C Multivitamins C Date:05/01/98ISR Number: 3167470-0Report Type:Periodic Company Report #US96122341A Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Health Zyprexa PS 5 MG/2 DAY Hospitalization - Hypertension Professional Initial or Prolonged Date:05/01/98ISR Number: 3167471-2Report Type:Periodic Company Report #US96123139A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Hostility Health Klonopin C Paranoia Professional Tylenol C 24-Jun-2005 12:19 PM Page: 313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3167472-4Report Type:Periodic Company Report #US96123736A Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Zyprexa PS 5 MG/1 DAY 9 DAY Initial or Prolonged Cough Furosemide C Faecal Incontinence Haloperidol C Pyrexia Clonazepam C Sedation Diphenhydramine C Stupor Cimetidine C Urinary Tract Disorder Terazosin C Date:05/01/98ISR Number: 3167473-6Report Type:Periodic Company Report #US96123886A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Zyprexa PS Initial or Prolonged Professional Date:05/01/98ISR Number: 3167494-3Report Type:Periodic Company Report #US98030667A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS 5 MG Initial or Prolonged Paranoia Health Personality Disorder Professional Date:05/01/98ISR Number: 3167496-7Report Type:Periodic Company Report #US98030670A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Study Zyprexa PS 2.5 MG/ 1 DAY Life-Threatening Pneumonia Health Sinemet C Hospitalization - Professional Potassium Chloride C Initial or Prolonged Lasix C Prazosin C Ibuprofen C Date:05/01/98ISR Number: 3167497-9Report Type:Periodic Company Report #US_980300005 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS 10 MG/1 DAY Initial or Prolonged Hyponatraemia Professional Fluphenazine C Vertigo Amitriptyline C Triamterene C Date:05/01/98ISR Number: 3167499-2Report Type:Periodic Company Report #US_980300072 Age:52 YR Gender:Female I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Diabetic Ketoacidosis Drug Ineffective Drug Level Below Therapeutic Hyperglycaemia 24-Jun-2005 12:19 PM Page: 314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polyuria Thirst Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 20 MG/1 DAY Professional Haldol C Depakote C Congentin C Paxil C Restoril C Vitamin E C Date:05/01/98ISR Number: 3167500-6Report Type:Periodic Company Report #US_980300556 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS 5 MG/1 DAY Initial or Prolonged Syndrome Professional Company Representative Date:05/01/98ISR Number: 3167502-XReport Type:Periodic Company Report #US_980300479 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS Initial or Prolonged Sedation Professional Speech Disorder Date:05/01/98ISR Number: 3167503-1Report Type:Periodic Company Report #US_980300363 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 20 MG/DAY Initial or Prolonged Professional Date:05/01/98ISR Number: 3167505-5Report Type:Periodic Company Report #US_980300358 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 20 MG/DAY Initial or Prolonged Professional Date:05/01/98ISR Number: 3167507-9Report Type:Periodic Company Report #US98030718A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS 5 MG/ 1 DAY Weight Increased Professional Luvox C Date:05/01/98ISR Number: 3167509-2Report Type:Periodic Company Report #US_980300148 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa (Olanzapine) PS 7 MON Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3167511-0Report Type:Periodic Company Report #US_980300068 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS 10 MG/DAY Professional Date:05/01/98ISR Number: 3167513-4Report Type:Periodic Company Report #US_980300071 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS 2.5 MG/DAY Sinemet C Date:05/01/98ISR Number: 3167515-8Report Type:Periodic Company Report #US_980300017 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS 15 MG/DAY Lithium C Sinequan C Navane C Date:05/01/98ISR Number: 3167710-8Report Type:Periodic Company Report #US97054936A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Prozac PS 20 MG Initial or Prolonged Sedation Professional Zyprexa SS 10 MG Required Intervention to Prevent Permanent Impairment/Damage Date:05/01/98ISR Number: 3167712-1Report Type:Periodic Company Report #US97054927A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS 300 MG Initial or Prolonged Sedation Professional Thinking Abnormal Date:05/01/98ISR Number: 3167714-5Report Type:Periodic Company Report #US97054300A Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Health Asa C Professional Vitamin B12 C Folic Acid C Lactulose C Surfak C 24-Jun-2005 12:19 PM Page: 316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3167715-7Report Type:Periodic Company Report #US97052998A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 20 MG 1 DAY Initial or Prolonged Psychotic Disorder Health Prozac C Thinking Abnormal Professional Cogentin C Ativan C Date:05/01/98ISR Number: 3167717-0Report Type:Periodic Company Report #US97052737A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zyprexa PS 10 MG 1 DAY 2 WK Initial or Prolonged Apathy Professional Clozapine C Aspartate Aminotransferase Increased Asthenia Blood Creatine Phosphokinase Increased Delusion Dyskinesia Hyperhidrosis Hyperventilation Hypocalcaemia Hypokalaemia Hypoproteinaemia Insomnia Monocytosis Nervousness Paranoia Tachycardia Date:05/01/98ISR Number: 3167719-4Report Type:Periodic Company Report #US97051204A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Health Zyprexa PS 10 MG 1 DAY Hospitalization - Professional Initial or Prolonged Company Representative Date:05/01/98ISR Number: 3167720-0Report Type:Periodic Company Report #US97051201A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Consumer Zyrpexa PS Hospitalization - Health Lithium C Initial or Prolonged Professional Date:05/01/98ISR Number: 3167726-1Report Type:Periodic Company Report #US98023238A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS Initial or Prolonged Intentional Misuse Professional Stupor 24-Jun-2005 12:19 PM Page: 317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3167729-7Report Type:Periodic Company Report #US98022416A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS 10MG 1 DAY Initial or Prolonged Health Chloral Hydrate C Professional Stelazine C Vitamin B C Vitamin A C Yohimbine C Vitamin E C Date:05/01/98ISR Number: 3167733-9Report Type:Periodic Company Report #US98022419A Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Study Zyprexa PS 5MG DAY Initial or Prolonged Health Professional Date:05/01/98ISR Number: 3167736-4Report Type:Periodic Company Report #US98022074A Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Study Zyprexa PS 5MG 1 DAY Initial or Prolonged Health Other Professional Date:05/01/98ISR Number: 3167743-1Report Type:Periodic Company Report #US98022083A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Zyprexa PS 5MG 1 DAY Health Calcium C Professional Peridex C Naprosyn C Date:05/01/98ISR Number: 3167747-9Report Type:Periodic Company Report #US98022086A Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Zyprexa PS 10MG /1 DAY Health Betagan C Professional Prinivil C Tums C Ensure Plus C Multivitamin C Debrox C Zostrix C Levobunolol C Date:05/01/98ISR Number: 3167749-2Report Type:Periodic Company Report #US98022098A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Hyperglycaemia Health Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 10MG 1 DAY, PO 1 YR Navane C Depakote C Date:05/01/98ISR Number: 3167750-9Report Type:Periodic Company Report #US98021759A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 20MG 1 DAY Initial or Prolonged Health Ativan C Professional Date:05/01/98ISR Number: 3167751-0Report Type:Periodic Company Report #US98021129A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Zyprexa PS 10MG /1 DAY Initial or Prolonged Bradycardia Professional Synthroid C Dizziness Other Dyazide C Hypertonia Paxil C Paraesthesia Atenolol C Syncope Tremor Date:05/01/98ISR Number: 3167753-4Report Type:Periodic Company Report #US98020907A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Zyprexa PS Initial or Prolonged Professional Risperidone C Other Bethanechol C Ciprofloxacin C Date:05/01/98ISR Number: 3168041-2Report Type:Periodic Company Report #US97074300A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa PS Professional Date:05/01/98ISR Number: 3168043-6Report Type:Periodic Company Report #US97074306A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS 20 MG/DAY 1 WK Initial or Prolonged Hyponatraemia Professional Clonazepam C Miosis Other Albuterol C Sedation Vasotec C Stupor Lasix C Tegretol C Iron C Multivitamins C 24-Jun-2005 12:19 PM Page: 319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin (Acetylsalicylic Acid) C Glipizide C Nitroglycerin (Glyceryl Trinitrate) C Date:05/01/98ISR Number: 3168046-1Report Type:Periodic Company Report #US97073247A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS 20 MG/DAY 3 MON Initial or Prolonged Phosphokinase Increased Professional Myalgia Myopathy Date:05/01/98ISR Number: 3168047-3Report Type:Periodic Company Report #US97072800A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Zyprexa PS 2.5 MG/DAY Initial or Prolonged Syncope Professional Other Date:05/01/98ISR Number: 3168049-7Report Type:Periodic Company Report #US97073049A Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Study Zyprexa PS 10 MG/DAY Initial or Prolonged Ecchymosis Health Risperdal C Sedation Professional Multivitamins C Syncope Date:05/01/98ISR Number: 3168052-7Report Type:Periodic Company Report #US97072320A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Zyprexa PS 15 MG/ DAY Professional Depakote C Prozac C Date:05/01/98ISR Number: 3168054-0Report Type:Periodic Company Report #US97072476A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Zyprexa PS 20 MG/DAY 1 MON Initial or Prolonged Hypertension Professional Diltiazem C Other Mania Valproate Sodium C Clonazepam C Lisinopril C Aspirin C Lipitor C Estrogens C Lithium C 24-Jun-2005 12:19 PM Page: 320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3168060-6Report Type:Periodic Company Report #US97122671A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa (Olanzapine) PS 20 MG DAY 4 MON Initial or Prolonged Coordination Abnormal Professional Zoloft C Hypertonia Pamelor C Pyrexia Ritalin C Sedation Speech Disorder Date:05/01/98ISR Number: 3168063-1Report Type:Periodic Company Report #US97123277A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Health Zyprexa (Olanzapine) PS 15 MG /1 DAY Hospitalization - Blood Creatine Professional Inderal La C Initial or Prolonged Phosphokinase Increased Amantadine C Delirium Cardura C Extrapyramidal Disorder Cogentin C Gait Disturbance Antacid C Hypertonia Tylenol C Liver Function Test Multivitamin C Abnormal Ativan C Neuroleptic Malignant Perphenazine C Syndrome Lithium C Pyrexia Depakote C Sedation Tremor Date:05/01/98ISR Number: 3168066-7Report Type:Periodic Company Report #US97123682A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS 3 DAY Phosphokinase Increased Professional Wellbutrin C Delirium Trazodone C Leukocytosis Neuroleptic Malignant Syndrome Date:05/01/98ISR Number: 3168070-9Report Type:Periodic Company Report #US97124420A Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Liver Function Test Professional Risperdal C Abnormal Other Insulin C Pyrexia Mevacor C Vasodilatation Tegretol C Date:05/01/98ISR Number: 3168075-8Report Type:Periodic Company Report #US97124444A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Study Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Health Sertraline C Professional 24-Jun-2005 12:19 PM Page: 321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3168304-0Report Type:Periodic Company Report #US97105395A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Insomnia Health Lithobid C Mania Professional Date:05/01/98ISR Number: 3168330-1Report Type:Periodic Company Report #US97125710A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa (Olanzapine) PS 10 MG / 1 DAY Initial or Prolonged Insomnia Health Speech Disorder Professional Thinking Abnormal Date:05/01/98ISR Number: 3168331-3Report Type:Periodic Company Report #US98010496A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Zyprexa (Olanzapine) PS 5 MG Hospitalization - Health Nph Iletin C Initial or Prolonged Professional Colace C Iron C Date:05/04/98ISR Number: 3073461-0Report Type:Expedited (15-DaCompany Report #US_980401282 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Zyprexa PS 40 MG / DAY Life-Threatening Phosphokinase Increased Professional Serzone C Hospitalization - Cardiac Arrest Other Amantadine C Initial or Prolonged Hypokalaemia Synthroid C Other Intestinal Ischaemia Ativan C Lung Infiltration Bentyl C Neuroleptic Malignant Syndrome Pyrexia Renal Failure Date:05/04/98ISR Number: 3073473-7Report Type:Expedited (15-DaCompany Report #GBS980400386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa PS Initial or Prolonged Drug Ineffective Health Flupentixol C Ecchymosis Professional Date:05/04/98ISR Number: 3073474-9Report Type:Expedited (15-DaCompany Report #GBS980400386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa PS Initial or Prolonged Drug Effect Decreased Health Flupentixol C Ecchymosis Professional Other 24-Jun-2005 12:19 PM Page: 322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/98ISR Number: 3073477-4Report Type:Expedited (15-DaCompany Report #EWC980300200 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Zyprexa PS Hospitalization - Syncope Health Kemadrin C Initial or Prolonged Professional Promethazine C Date:05/04/98ISR Number: 3073499-3Report Type:Expedited (15-DaCompany Report #FR98020115A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Zyprexa PS 20 MG/DAY Initial or Prolonged Health Professional Company Representative Date:05/04/98ISR Number: 3074172-8Report Type:Expedited (15-DaCompany Report #US-980402555 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS 15 MG/DAY Medication Error Professional Date:05/04/98ISR Number: 3074173-XReport Type:Expedited (15-DaCompany Report #US-980402318 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Consumer Zyprexa PS 10 MG/1 DAY Initial or Prolonged Paranoia Chlorpromazine C Benztropine C Date:05/04/98ISR Number: 3074175-3Report Type:Expedited (15-DaCompany Report #US-980402295 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS 10 MG/1 DAY Professional Paxil C Company Synthroid C Representative Date:05/04/98ISR Number: 3074176-5Report Type:Expedited (15-DaCompany Report #US_980402314 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Zyprexa PS ORAL 10 MG/1 DAY Professional ORAL 1 YR Date:05/04/98ISR Number: 3074177-7Report Type:Expedited (15-DaCompany Report #US_980402301 Age:11 YR Gender:Female I/FU:I Outcome PT Hospitalization - Amnesia Initial or Prolonged Asthenia Coordination Abnormal 24-Jun-2005 12:19 PM Page: 323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Above Therapeutic Electroencephalogram Report Source Product Role Manufacturer Route Dose Duration Abnormal Consumer Zyprexa PS 10 MG/2 DAY Fall Depakote C ORAL 1000 MG/1 DAY Headache PO Heart Rate Irregular Hypertension Hypotonia Nausea Nervous System Disorder Sedation Date:05/04/98ISR Number: 3074180-7Report Type:Expedited (15-DaCompany Report #EWC980400442 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Foreign Zyprexa PS ORAL 20 MG/DAY Drug Withdrawal Syndrome Health ORAL Mania Professional Haldol C Company Representative Other Date:05/04/98ISR Number: 3074182-0Report Type:Expedited (15-DaCompany Report #US_980402205 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Zyprexa PS ORAL 5 MG BID ORAL 2 MON Pulmonary Embolism Professional Depakote C Date:05/04/98ISR Number: 3074185-6Report Type:Expedited (15-DaCompany Report #EWC980400434 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa PS 15 MG/ DAY Initial or Prolonged Pulmonary Hypertension Health Zuclopenthixol C Professional Flufenazin C Date:05/04/98ISR Number: 3074187-XReport Type:Expedited (15-DaCompany Report #EWC980400445 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa PS ORAL 20 MG /DAY Hospitalization - Hyperglycaemia Health ORAL Initial or Prolonged Respiratory Disorder Professional Date:05/04/98ISR Number: 3074214-XReport Type:Expedited (15-DaCompany Report #US_980401194 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Literature Zyprexa PS 7.5 MG/1 AT Initial or Prolonged Health BEDTIME 3 WK Professional 24-Jun-2005 12:19 PM Page: 324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/98ISR Number: 3074216-3Report Type:Expedited (15-DaCompany Report #US_980402483 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa PS ORAL 10 MG/ 1 DAY Blood Potassium Decreased Study ORAL Paralysis Health Glucurolactone C Professional Date:05/04/98ISR Number: 3074219-9Report Type:Expedited (15-DaCompany Report #GBS980300061 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Zyprexa PS 10 MG/2 DAY Initial or Prolonged Cardiac Disorder Consumer Trifluoperazine C Dyspnoea Health Orphenadrine C Hyperhidrosis Professional Pipotiazine C Sedation Tachypnoea Date:05/04/98ISR Number: 3074257-6Report Type:Expedited (15-DaCompany Report #EWC980400376 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Damage Foreign Zyprexa PS ORAL 10 MG /QD Other Brain Oedema Health ORAL Coma Professional Obsidan (Propranolol Disorientation Hydrochloride) C Inosine C Date:05/04/98ISR Number: 3074259-XReport Type:Expedited (15-DaCompany Report #EWC980400413 Age:2 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Zyprexa PS ORAL 15 MG /DAY Initial or Prolonged Health ORAL Professional Akineton (Biperiden Hydrochloride) C Date:05/04/98ISR Number: 3074269-2Report Type:Expedited (15-DaCompany Report #GBS980400359 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Zyprexa PS 60 MG DAY Initial or Prolonged Medication Error Health Professional Date:05/05/98ISR Number: 3084014-2Report Type:Direct Company Report # Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Zyprexa PS 2.5MG QD 1 MON Prolixin Deconoate C 24-Jun-2005 12:19 PM Page: 325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/98ISR Number: 3091366-6Report Type:Expedited (15-DaCompany Report #US_980503236 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS 10 MG/1 DAY Initial or Prolonged Spinal Compression Professional Clopazine C Fracture Company Ativan C Representative Cogentin C Date:05/08/98ISR Number: 3091372-1Report Type:Expedited (15-DaCompany Report #US_980504151 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Consumer Zyprexa PS 15 MG/DAY 6 WK Prozac SS 80 MG/DAY Remeron C Coumadin C Date:05/08/98ISR Number: 3091502-1Report Type:Expedited (15-DaCompany Report #US_980604306 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa PS 10 MG/1 DAY Initial or Prolonged Prothrombin Time Professional Desyrel C Prolonged Company Representative Date:05/12/98ISR Number: 3076969-7Report Type:Expedited (15-DaCompany Report #US_980502903 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Zyprexa PS 600 MG/DAY Restlessness Professional Trazodone C Sedation Tachycardia Date:05/12/98ISR Number: 3076971-5Report Type:Expedited (15-DaCompany Report #US-980402805 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa PS 5 MG/1 DAY Cardio-Respiratory Arrest Professional Lopressor C Coma Zoloft C Sorbitol C Clozaril C Date:05/12/98ISR Number: 3076972-7Report Type:Expedited (15-DaCompany Report #US_980402796 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Consumer Zyprexa PS 10 MG/1 DAY Initial or Prolonged Pain Prozac C Pancreatitis Valium C 24-Jun-2005 12:19 PM Page: 326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/98ISR Number: 3076974-0Report Type:Expedited (15-DaCompany Report #US 98020907A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Zyprexa PS 15 MG / 1 DAY Initial or Prolonged Neutropenia Professional Risperidone C Other Benztropine C Bethanechol C Ciprofloxacin C Date:05/12/98ISR Number: 3076976-4Report Type:Expedited (15-DaCompany Report #GBS980400429 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Euphoric Mood Consumer Psychotic Disorder Date:05/12/98ISR Number: 3076987-9Report Type:Expedited (15-DaCompany Report #US_980502956 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Overdose Health Professional Other Date:05/12/98ISR Number: 3077035-7Report Type:Expedited (15-DaCompany Report #US_980300208 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Zyprexa PS Hospitalization - Phosphokinase Increased Professional Amantadine C Initial or Prolonged Chest Pain Neuroleptic Malignant Syndrome Pyrexia Date:05/12/98ISR Number: 3077038-2Report Type:Expedited (15-DaCompany Report #US_980401282 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Zyprexa PS 40MG/DAY Life-Threatening Phosphokinase Increased Professional Serzone C Hospitalization - Cardiac Arrest Other Amantadine C Initial or Prolonged Chest Pain Synthroid C Other Coronary Artery Surgery Ativan C Hypokalaemia Bentyl C Intestinal Ischaemia Lung Infiltration Neuroleptic Malignant Syndrome Pyrexia Renal Failure 24-Jun-2005 12:19 PM Page: 327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/98ISR Number: 3077041-2Report Type:Expedited (15-DaCompany Report #US-980300067 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa PS 7.5 MG/1 DAY 3 WK Hospitalization - Congestive Professional Risperdal C Initial or Prolonged Confusional State Other Depressed Level Of Consciousness Leukocytosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Pyrexia Respiratory Depression Respiratory Failure Sepsis Tachycardia Tremor Date:05/12/98ISR Number: 3077049-7Report Type:Expedited (15-DaCompany Report #US98012299A Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Zyprexa PS 5 MG/ 2 DAY 4 MON Professional Date:05/12/98ISR Number: 3077059-XReport Type:Expedited (15-DaCompany Report #FR98011009A Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Lung Disorder Health Athymil C Professional Nozinan C Lexomil C Date:05/12/98ISR Number: 3077063-1Report Type:Expedited (15-DaCompany Report #GBS 980400384 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS 15 MG DAY Health Professional Date:05/12/98ISR Number: 3077066-7Report Type:Expedited (15-DaCompany Report #EWC980400445 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa PS 20 MG/DAY Hospitalization - Hyperglycaemia Health Initial or Prolonged Respiratory Disorder Professional 24-Jun-2005 12:19 PM Page: 328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/98ISR Number: 3077068-0Report Type:Expedited (15-DaCompany Report #EWC980300200 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Zyprexa PS Initial or Prolonged Syncope Health Kemadrin C Professional Promethazine C Date:05/12/98ISR Number: 3077072-2Report Type:Expedited (15-DaCompany Report #US_980401326 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa PS 5 MG/DAY Initial or Prolonged Cholecystitis Health Sodium Valproate C Jaundice Professional Trifluoperazine C Liver Function Test Chlorpromazine C Abnormal Date:05/12/98ISR Number: 3077374-XReport Type:Expedited (15-DaCompany Report #GBS980400332 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Foreign Zyprexa PS 5MG/1 DAY Emotional Distress Health Professional Date:05/12/98ISR Number: 3077379-9Report Type:Expedited (15-DaCompany Report #EWC980400532 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS 80MG/DAY Initial or Prolonged Sedation Health Professional Date:05/12/98ISR Number: 3077382-9Report Type:Expedited (15-DaCompany Report #EWC980400534 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhage Subcutaneous Foreign Zyprexa PS 10M/DAY Health Clonazepam C Professional Date:05/12/98ISR Number: 3077386-6Report Type:Expedited (15-DaCompany Report #EWC980400472 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 10MG/DAY 5 WK Life-Threatening Health Professional Date:05/12/98ISR Number: 3077390-8Report Type:Expedited (15-DaCompany Report #EWC980400469 Age:44 YR Gender:Male I/FU:I Outcome PT Hospitalization - Attention Initial or Prolonged Deficit/Hyperactivity 24-Jun-2005 12:19 PM Page: 329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorder Catatonia Disorientation Hallucination Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Foreign Zyprexa PS 10 MG/DAY Health Deroxat(Paroxetine Professional Hydrocholride) C Valprorate Sodium C Clozapine C Date:05/12/98ISR Number: 3077394-5Report Type:Expedited (15-DaCompany Report #US_980502962 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS Initial or Prolonged Agitation Professional Trazodone C Intentional Misuse Tiotixene C Navane C Date:05/12/98ISR Number: 3079906-4Report Type:Direct Company Report # Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Zyprexia PS Lilly Initial or Prolonged Lethargy Zyetec C 10 MG QD PRN Medication Error PO Pyrexia Date:05/12/98ISR Number: 3079907-6Report Type:Direct Company Report # Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Zyprexa PS Neutropenia Benadryl C White Blood Cell Count Desyrel C Decreased Thiamine C Mvi C Date:05/15/98ISR Number: 3078116-4Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Zyprexa PS ORAL 10 MG PO HS Pityriasis Rosea Pruritus Date:05/18/98ISR Number: 3079346-8Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Zyprexa PS 2.5 MG BID Phosphokinase Increased Zyprexa SS 5MG HS Neuroleptic Malignant Eskalith Cr C Syndrome Desyrel C Droperidol C Losartan C Hydrochlorothiazide C 24-Jun-2005 12:19 PM Page: 330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Norvasc C Lorezepam C Nitroglycerine Patch C Aspirin C Cardira C Pepcid C Date:05/18/98ISR Number: 3079991-XReport Type:Expedited (15-DaCompany Report #US98023787A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS 40 MG/ 1 DAY Initial or Prolonged Arrhythmia Professional Dilantin C Bilirubinuria Other Furosemide C Cardiac Failure Congestive Hyperbilirubinaemia Hyponatraemia Liver Function Test Abnormal Nausea Supraventricular Tachycardia Thrombocytopenia Vomiting Date:05/18/98ISR Number: 3079999-4Report Type:Expedited (15-DaCompany Report #US_980402483 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa PS 10 MG/1 DAY Hospitalization - Hypokalaemia Study Glucurolactone C Initial or Prolonged Paralysis Health Professional Date:05/18/98ISR Number: 3080004-4Report Type:Expedited (15-DaCompany Report #US_980300331 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Placebo PS UNK Initial or Prolonged Constipation Study Zyprexa SS 5 MG/1 DAY Intestinal Obstruction Health Modopar C Professional Hept-A-Myl C Rythmodan C Aspegic C Equanil C Lubentyl C Liquid Paraffin And Magnesium Hydroxide C Peristaltine C Date:05/18/98ISR Number: 3080009-3Report Type:Expedited (15-DaCompany Report #GBS980300227 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Other Neuroleptic Malignant Foreign Syndrome Health 24-Jun-2005 12:19 PM Page: 331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS 20 MG DAY Valproate Sodium C Carbamazepine C Orphenadrine C Thyroxine Sodium C Date:05/18/98ISR Number: 3080014-7Report Type:Expedited (15-DaCompany Report #EWC980400325 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Intestinal Functional Health Dytide H C Required Disorder Professional Adumbran C Intervention to Magnesium Verla Prevent Permanent Dragees C Impairment/Damage Date:05/18/98ISR Number: 3080019-6Report Type:Expedited (15-DaCompany Report #US97122557A Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa PS 15 MG/ 1 DAY Initial or Prolonged Dehydration Professional Uniphyl C Other Impaired Gastric Emptying Atrovent C Nausea Flovent C Prothrombin Time Intal C Prolonged Ventolin C Pulmonary Embolism Depakote C Pyrexia Aldactone C Sarcoidosis Cytomel C Vomiting Provera C Climara C Xanax C Date:05/18/98ISR Number: 3080022-6Report Type:Expedited (15-DaCompany Report #US_980402483 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa PS 10 MG/1 DAY Hospitalization - Hypokalaemia Study Glucurolactone C Initial or Prolonged Paralysis Health Professional Other Date:05/18/98ISR Number: 3080031-7Report Type:Expedited (15-DaCompany Report #GBS 980400364 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zyprexa PS 10MG/ 1DAY Initial or Prolonged Euphoric Mood Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/98ISR Number: 3080050-0Report Type:Expedited (15-DaCompany Report #US_980402318 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa PS 10 MG 1 DAY Initial or Prolonged Delusion Health Chlorpromazine C Mental Impairment Professional Benztropine C Paranoia Litho C Date:05/18/98ISR Number: 3080668-5Report Type:Expedited (15-DaCompany Report #EWC980500589 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa PS 10 MG/DAY 7 WK Initial or Prolonged Laryngeal Oedema Health Anafranil C Schizophrenia Professional Company Representative Date:05/18/98ISR Number: 3080669-7Report Type:Expedited (15-DaCompany Report #AU 980500012 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Phosphokinase Increased Health Haloperidol C Other Muscle Rigidity Professional Neuroleptic Malignant Syndrome Pyrexia White Blood Cell Count Increased Date:05/18/98ISR Number: 3080927-6Report Type:Expedited (15-DaCompany Report #US_980503243 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS 170 MG Initial or Prolonged Anger Professional Ativan C Overdose Urethral Discharge Urethral Pain Date:05/18/98ISR Number: 3080930-6Report Type:Expedited (15-DaCompany Report #US97114129A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS 10 MG/ 1 DAY Initial or Prolonged Colitis Professional Nortriptyline C Confusional State Company Prilosec C Depression Representative Lotensin C Diarrhoea Haematochezia Hypotension Ileitis Leukocytosis Pyrexia Renal Failure Acute Sepsis 24-Jun-2005 12:19 PM Page: 333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/98ISR Number: 3080940-9Report Type:Expedited (15-DaCompany Report #EWC980500582 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Oedema Peripheral Health Professional Company Representative Date:05/18/98ISR Number: 3080968-9Report Type:Expedited (15-DaCompany Report #US_980503349 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Company Zyprexa PS 10 MG/DAY Cerebrovascular Accident Representative Liver Function Test Abnormal Renal Failure Acute Date:05/18/98ISR Number: 3080969-0Report Type:Expedited (15-DaCompany Report #GBS980500498 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS 15 MG /DAY Initial or Prolonged Health Diltiazem C Professional Lithium Carbonate C Company Ranitidine C Representative Ibuprofen C Date:05/18/98ISR Number: 3080971-9Report Type:Expedited (15-DaCompany Report #EWC980500584 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Health Professional Company Representative Date:05/18/98ISR Number: 3080973-2Report Type:Expedited (15-DaCompany Report #EWC980500575 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Zyprexa PS Initial or Prolonged Health Professional Date:05/18/98ISR Number: 3080974-4Report Type:Expedited (15-DaCompany Report #EWC980500612 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa PS 10 MG/DAY Myocardial Infarction Health En C Professional Halcion C 24-Jun-2005 12:19 PM Page: 334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/98ISR Number: 3080976-8Report Type:Expedited (15-DaCompany Report #US_980503251 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS 250 MG/DAY Initial or Prolonged Professional Date:05/18/98ISR Number: 3080985-9Report Type:Expedited (15-DaCompany Report #US_980503307 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Effexor C Date:05/18/98ISR Number: 3080987-2Report Type:Expedited (15-DaCompany Report #US_980503378 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Health Zyprexa PS 10 MG/1 DAY Professional Coumadin C Date:05/20/98ISR Number: 3080522-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Zyprexa PS 10 MG 10 DAY Drug Ineffective Zyrtec SS 10 MG 10 DAY Medication Error Date:05/20/98ISR Number: 3167356-1Report Type:Periodic Company Report #8-98079-011D Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Effexor Xr PS ORAL 300 MG DAILY Weight Increased Professional ORAL Zyprexa SS Date:05/22/98ISR Number: 3084577-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Zyprexa PS Dizziness Headache Date:05/26/98ISR Number: 3082535-XReport Type:Expedited (15-DaCompany Report #GBS980400384 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS 15 MG DAY Health Miconazole Nitrate C Professional 24-Jun-2005 12:19 PM Page: 335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3082540-3Report Type:Expedited (15-DaCompany Report #US_980502956 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 10 MG/DAY Overdose Health Loxapac C Professional Other Date:05/26/98ISR Number: 3082543-9Report Type:Expedited (15-DaCompany Report #US_980300015 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Study Zyprexa PS 10 MG/1 DAY Atherosclerosis Health Haloperidol Professional Decanoate C Trihexyphenidyl C Trazodone C Date:05/26/98ISR Number: 3082545-2Report Type:Expedited (15-DaCompany Report #GBS980300188 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Foreign Zyprexa PS UNK Hypothermia Health Trifluoperazine C Professional Other Date:05/26/98ISR Number: 3082549-XReport Type:Expedited (15-DaCompany Report #US98014615A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Health Zyprexa PS 5 MG/ 1 DAY Blood Ethanol Increased Professional Erythrocin C Completed Suicide Semisodium C Overdose Date:05/26/98ISR Number: 3083058-4Report Type:Expedited (15-DaCompany Report #GBS980500504 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Zyprexa PS Initial or Prolonged Health Professional Date:05/26/98ISR Number: 3083075-4Report Type:Expedited (15-DaCompany Report #US-980401299 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Venlafaxine C 24-Jun-2005 12:19 PM Page: 336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3083076-6Report Type:Expedited (15-DaCompany Report #US-980503691 Age:39 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa PS 35 MG/DAY Professional Ativan C Neurontin C Effexor C Date:05/26/98ISR Number: 3083077-8Report Type:Expedited (15-DaCompany Report #US-980503700 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Encephalopathy Health Zyprexa PS Initial or Prolonged Hyperbilirubinaemia Professional Trazodone C Jaundice Date:05/26/98ISR Number: 3083079-1Report Type:Expedited (15-DaCompany Report #GBS980400389 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa PS Initial or Prolonged Hypotension Health Promazine C Professional Lorazepam C Company Aspirin C Representative Date:05/26/98ISR Number: 3083080-8Report Type:Expedited (15-DaCompany Report #GBS980500474 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS 20 MG DAY Initial or Prolonged Electrocardiogram T Wave Health Inversion Professional Pericarditis Date:05/26/98ISR Number: 3083082-1Report Type:Expedited (15-DaCompany Report #US-980503349 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Zyprexa PS 10 MG/DAY Other Cerebrovascular Accident Professional Liver Function Test Company Abnormal Representative Renal Failure Date:05/26/98ISR Number: 3083083-3Report Type:Expedited (15-DaCompany Report #GBS980500509 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Zyprexa PS Decreased Health Professional 24-Jun-2005 12:19 PM Page: 337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3083085-7Report Type:Expedited (15-DaCompany Report #GB98025170A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa PS 20 MG DAY Urticaria Health Fluoxetine C Professional Diazepam C Company Thioridazine C Representative Other Date:05/26/98ISR Number: 3083088-2Report Type:Expedited (15-DaCompany Report #GBS980400363 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Euphoric Mood Foreign Zyprexa PS Initial or Prolonged Mania Health Professional Company Representative Date:05/26/98ISR Number: 3083095-XReport Type:Expedited (15-DaCompany Report #US97122557A Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa PS 15 MG/1 DAY Initial or Prolonged Dehydration Professional Uniphyl C Other Impaired Gastric Emptying Atrovent C Nausea Flovent C Prothrombin Time Intal C Prolonged Ventolin C Pulmonary Embolism Depakote C Pyrexia Aldactone C Sarcoidosis Cytomel C Vomiting Provera C Climara C Xanax C Date:05/26/98ISR Number: 3083096-1Report Type:Expedited (15-DaCompany Report #US97091735A Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Health Zyprexa PS 5 MG 1 DAY 3 MON Initial or Prolonged Hyperglycaemia Professional Paxil C Hypersomnia Company Ativan C Mania Representative Klonopin C Nervousness Personality Disorder Polydipsia Date:05/26/98ISR Number: 3083102-4Report Type:Expedited (15-DaCompany Report #US_980402483 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Foreign Zyprexa PS 10 MG/1 DAY Initial or Prolonged Paralysis Study Glucurolactone C Health Professional 24-Jun-2005 12:19 PM Page: 338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3083108-5Report Type:Expedited (15-DaCompany Report #EWC980400413 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Health Akineton (Biperiden Professional Hydrochloride) C Date:05/26/98ISR Number: 3083156-5Report Type:Expedited (15-DaCompany Report #US-980503307 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Effexor C Date:05/26/98ISR Number: 3083158-9Report Type:Expedited (15-DaCompany Report #US_980503243 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS 170MG Initial or Prolonged Intentional Misuse Professional Ativan C 1 WK Lethargy Urethral Discharge Urethral Pain Date:05/26/98ISR Number: 3083160-7Report Type:Expedited (15-DaCompany Report #US_980401900 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Detachment Health Zyprexa PS 10 MG/1 DAY 8 MON Retinal Disorder Professional Date:05/26/98ISR Number: 3084598-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersomnia Zyprexa PS Date:05/28/98ISR Number: 3083087-0Report Type:Expedited (15-DaCompany Report #GBS980400365 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Euphoric Mood Foreign Zyprexa PS 15 MG/1 DAY Initial or Prolonged Mania Health Professional Company Representative Date:06/01/98ISR Number: 3087325-XReport Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Disability Required 24-Jun-2005 12:19 PM Page: 339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Zyprexa PS ORAL PO 5 MG QDAY Diarrhoea Tagamet C Dyspnoea Exacerbated Afrinol C Dyspnoea Exertional Fatigue Hypoxia Nausea Pneumonia Rales Date:06/01/98ISR Number: 3087327-3Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Zyprexa PS ORAL 5 MG PO QD Hospitalization - Depakote SS ORAL 250 MG PO TID Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:06/01/98ISR Number: 3087704-0Report Type:Expedited (15-DaCompany Report #AU_980500012 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 10 MG/1 DAY Initial or Prolonged Phosphokinase Increased Health Haloperidol C Other Mental Impairment Professional Thioridazine C Neuroleptic Malignant Syndrome Pneumonia Pyrexia White Blood Cell Count Increased Date:06/01/98ISR Number: 3087707-6Report Type:Expedited (15-DaCompany Report #GBS980400386 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Bone Marrow Depression Health Flupentixol C Ecchymosis Professional Pancytopenia Other Date:06/01/98ISR Number: 3087713-1Report Type:Expedited (15-DaCompany Report #US980502956 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 10 MG/DAY Intentional Misuse Health Loxapac C Professional Other 24-Jun-2005 12:19 PM Page: 340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/98ISR Number: 3087720-9Report Type:Expedited (15-DaCompany Report #US_980300331 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS 5 MG/1 DAY Initial or Prolonged Constipation Study Modopar C Intestinal Obstruction Health Hept-A-Myl C Weight Decreased Professional Rythmodan C Aspegic C Equanil C Lubentyl C Liquid Paraffin And Magnesium Hydroxide C Peristaltine C Date:06/01/98ISR Number: 3087726-XReport Type:Expedited (15-DaCompany Report #US97121714A Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS 10 MG/1 DAY Initial or Prolonged Agitation Professional Effexor C Aspartate Company Klonopin C Aminotransferase Representative Trazodone C Increased Ambien C Blood Creatine Phosphokinase Increased Coma Delirium Difficulty In Walking Excitability Miosis Myoglobinuria Overdose Pupillary Reflex Impaired Renal Impairment Rhabdomyolysis Sciatic Nerve Injury Sinus Tachycardia Speech Disorder Stupor Tachycardia Date:06/01/98ISR Number: 3087761-1Report Type:Expedited (15-DaCompany Report #EWC980500706 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 10 MG/DAY Life-Threatening Health Professional Date:06/01/98ISR Number: 3087762-3Report Type:Expedited (15-DaCompany Report #US_980503841 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Intracranial Health Zyprexa PS 10 MG/1DAY Hypertension Professional Bupropion C Lithium C 24-Jun-2005 12:19 PM Page: 341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/98ISR Number: 3087764-7Report Type:Expedited (15-DaCompany Report #US_980503844 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Zyprexa PS 2.5 MG/1 DAY Professional Imdur C Syntrhoid C Bupropion C Date:06/01/98ISR Number: 3087765-9Report Type:Expedited (15-DaCompany Report #GBS980500590 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Date:06/01/98ISR Number: 3087768-4Report Type:Expedited (15-DaCompany Report #US_980503892 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Olanzapine PS 25 MG/DAY Initial or Prolonged Schizophrenia Study Health Professional Date:06/01/98ISR Number: 3087769-6Report Type:Expedited (15-DaCompany Report #US_980503913 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Zyprexa PS 5 MG/DAY Initial or Prolonged Professional Prozac SS 60 MG/DAY Company Representative Date:06/01/98ISR Number: 3087771-4Report Type:Expedited (15-DaCompany Report #US_980503862 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alcohol Increased Health Zyprexa PS Initial or Prolonged Blood Creatine Professional Phosphokinase Increased Facial Palsy Intentional Misuse Loss Of Consciousness Date:06/01/98ISR Number: 3088468-7Report Type:Expedited (15-DaCompany Report #EWC980500699 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS 5 MG/DAY Initial or Prolonged Oedema Peripheral Health Lanacrist C Professional Heminevrin C Other Absenor C Orudis C Imovane C Risperdal C Duphalac C 24-Jun-2005 12:19 PM Page: 342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/98ISR Number: 3088139-7Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS ORAL MG HS, PO Initial or Prolonged Joint Dislocation Professional Prozac SS UNKNOWN 20MG BID Urinary Incontinence Aricept C Premarin C Cardizem C Arabolic Steroid C Date:06/08/98ISR Number: 3091367-8Report Type:Expedited (15-DaCompany Report #US_980402331 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermal Cyst Consumer Zyprexa PS 20 MG/DAY Diffuse Large B-Cell Health Nortriptyline C Lymphoma Professional Lorazepam C Hyperhidrosis Artane C Spleen Disorder Atrifluoperazine C Tooth Discolouration Date:06/08/98ISR Number: 3091368-XReport Type:Expedited (15-DaCompany Report #EWC980500705 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS 5 MG/DAY Initial or Prolonged Oedema Peripheral Health Atarax C Professional Heminevrin C Other Behepan C Ventoline C Atrovent C Lasoc C Effexor C Date:06/08/98ISR Number: 3091369-1Report Type:Expedited (15-DaCompany Report #GBS 980500581 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intermittent Claudication Foreign Zyprexa PS Myocardial Infarction Health Peripheral Vascular Professional Disorder Company Representative Date:06/08/98ISR Number: 3091370-8Report Type:Expedited (15-DaCompany Report #US_980504112 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Zyprexa PS 10 MG/DAY 2 WK Dyspnoea Professional Albuterol C Cocaine C 24-Jun-2005 12:19 PM Page: 343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3091371-XReport Type:Expedited (15-DaCompany Report #US_980504148 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS 1400 MG/DAY Professional Date:06/08/98ISR Number: 3091388-5Report Type:Expedited (15-DaCompany Report #DE98022377A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa PS 5 MG Initial or Prolonged Dermatitis Health Penicillin C Dysphagia Professional Cotrim C Erythema Klacid C Leukopenia Lymphadenopathy Neutropenia Pneumonia Mycoplasmal Pyrexia Rash Erythematous Vomiting Date:06/08/98ISR Number: 3091390-3Report Type:Expedited (15-DaCompany Report #EWC 980300216 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest X-Ray Abnormal Foreign Zyprexa PS Initial or Prolonged Dermatitis Health Daktarin C Dysphagia Professional Seropram C Erythema Leukopenia Lymphadenopathy Nausea Neutropenia Pneumonia Mycoplasmal Pyrexia Viral Infection Vomiting Date:06/08/98ISR Number: 3091395-2Report Type:Expedited (15-DaCompany Report #US 980401900 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Zyprexa PS 10 MG/ 1 DAY Dysphagia Professional Leukopenia Lymphadenopathy Nausea Neutropenia Pneumonia Mycoplasmal Pyrexia Rash Erythematous Vomiting 24-Jun-2005 12:19 PM Page: 344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3091398-8Report Type:Expedited (15-DaCompany Report #US 980402295 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS 10 MG/ 1 DAY Professional Paxil C Company Synthroid C Representative Date:06/08/98ISR Number: 3091401-5Report Type:Expedited (15-DaCompany Report #US 9805603691 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa PS 35 MG/ DAY Professional Ativan C Neurontin C Effexor C Date:06/08/98ISR Number: 3091404-0Report Type:Expedited (15-DaCompany Report #US 980503700 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Bilirubin Increased Health Zyprexa PS Hospitalization - Hepatic Encephalopathy Professional Trazodone C Initial or Prolonged Hepatitis B Jaundice Date:06/08/98ISR Number: 3091500-8Report Type:Expedited (15-DaCompany Report #EWC980500703 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebothrombosis Foreign Zyprexa PS 5 MG/DAY Initial or Prolonged Health Heminevrin C Professional Behepan C Orasorbil C Effortil C Impugan C Nolvadex C Emgesan C Kalcitena C Trombyl C Acetylcysteine "Tika" C Risperdal C Duphalac C Remeron C Date:06/08/98ISR Number: 3091531-8Report Type:Expedited (15-DaCompany Report #CL 97075797A Age:30 YR Gender:Female I/FU:F Outcome PT Hospitalization - Depression Initial or Prolonged Drug Ineffective Dyspnoea Hyperglycaemia Hypersomnia Hypoglycaemia Hypomania 24-Jun-2005 12:19 PM Page: 345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Appetite Insulin Resistance Mania Report Source Product Role Manufacturer Route Dose Duration Schizophrenia Foreign Zyprexa PS 10 MG 1 DAY Sedation Consumer Prozac C Speech Disorder Health Weight Increased Professional Company Representative Date:06/08/98ISR Number: 3092063-3Report Type:Expedited (15-DaCompany Report #ES98014942A Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS 10 MG/ 1DAY Health Etumina C Professional Haloperidol C Lorazepam C Date:06/08/98ISR Number: 3092255-3Report Type:Expedited (15-DaCompany Report #EWC980600759 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Suicide Attempt Foreign Zyprexa PS 10 MG/DAY Health Professional Company Representative Other Date:06/08/98ISR Number: 3092256-5Report Type:Expedited (15-DaCompany Report #GBS980500603 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa PS Circulatory Collapse Health Depixol C Professional Sulpiride C Other Date:06/08/98ISR Number: 3092257-7Report Type:Expedited (15-DaCompany Report #EWC980300117 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa PS 20 MG/DAY Health Laroxyl C Professional Tranxene C Duphalac C Date:06/08/98ISR Number: 3092259-0Report Type:Expedited (15-DaCompany Report #GBS980500610 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Hypotension Health Aspirin C Laceration Professional Chlormethiazole C Sinus Bradycardia Other Promazine C 24-Jun-2005 12:19 PM Page: 346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Diazepam C Date:06/09/98ISR Number: 3090804-2Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Zyprexa PS Lilly ORAL 5 MG QHS PO Initial or Prolonged Therapeutic Lithium C Required Axid C Intervention to Cogentin C Prevent Permanent Albuterol Inhaler C Impairment/Damage Date:06/11/98ISR Number: 3092886-0Report Type:Direct Company Report # Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Zyprexa PS ORAL 2.5, 5, 10 MG QD PO Fecsol C Colace C Lortab C Vitamin E C Kcl C Lensin C Tylenol C Date:06/15/98ISR Number: 3094168-XReport Type:Expedited (15-DaCompany Report #DE98014972A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Zyprexa PS 10 MG / 1 DAY Hospitalization - Health Initial or Prolonged Professional Date:06/15/98ISR Number: 3094170-8Report Type:Expedited (15-DaCompany Report #CA_980600023 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa PS 10 MG/AT Initial or Prolonged Condition Aggravated Study BEDTIME Health Professional Date:06/15/98ISR Number: 3094172-1Report Type:Expedited (15-DaCompany Report #GBS980600635 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Health Sertraline C Professional Company Representative 24-Jun-2005 12:19 PM Page: 347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/98ISR Number: 3094174-5Report Type:Expedited (15-DaCompany Report #GBS980600637 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Zyprexa PS Health Professional Date:06/15/98ISR Number: 3094175-7Report Type:Expedited (15-DaCompany Report #AU_980600041 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 5 MG/1 DAY Hallucination, Auditory Health Modecate C Professional Vitamin E C Benztropine C Date:06/15/98ISR Number: 3094576-7Report Type:Expedited (15-DaCompany Report #EWC980600765 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Zyprexa PS 22.5 MG/DAY Hospitalization - Distress Syndrome Health Haloperidol C Initial or Prolonged Coma Professional Diazepam C Hypokalaemia Akineton C Hyponatraemia Lexaurin C Muscle Rigidity Polydipsia Restlessness Tremor Date:06/15/98ISR Number: 3094742-0Report Type:Expedited (15-DaCompany Report #GBS980600666 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Myocarditis Health Tachycardia Professional Date:06/15/98ISR Number: 3095054-1Report Type:Expedited (15-DaCompany Report #US_980604537 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Zyprexa PS 7.5 MG/DAY Brain Damage Professional Navane C Coma Lithobid C Condition Aggravated Tegretol C Electrocardiogram Change Cogentin C Paralysis Ativan C Psychotic Disorder Vomiting 24-Jun-2005 12:19 PM Page: 348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/98ISR Number: 3095055-3Report Type:Expedited (15-DaCompany Report #US_980604766 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa PS NI Professional Date:06/15/98ISR Number: 3095056-5Report Type:Expedited (15-DaCompany Report #GBS 980600636 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa PS 15 MG DAY Health Carbamazepine C Professional Fluphenazine Company Decanoate C Representative Paroxetine C Procyclidine C Zopiclone C Date:06/16/98ISR Number: 3094206-4Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eye Disorder Zeprexa PS 15 MG 2 X DAY Hospitalization - Nervous System Disorder Ativan SS Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage Date:06/16/98ISR Number: 3094554-8Report Type:Expedited (15-DaCompany Report #GBS980500474 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS 20 MG DAY Initial or Prolonged Electrocardiogram T Wave Health Amitriptyline C Inversion Professional Pericarditis Other Date:06/16/98ISR Number: 3094556-1Report Type:Expedited (15-DaCompany Report #US_980300331 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Foreign Zyprexa PS 5 MG/1DAY Initial or Prolonged Megacolon Study Modopar C Weight Decreased Health Hept-A-Myl C Professional Rythmodan C Aspegic C Equanil C Lubentyl C Liquid Paraffin C Peristaltine C 24-Jun-2005 12:19 PM Page: 349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/98ISR Number: 3095139-XReport Type:Expedited (15-DaCompany Report #EWC980400267 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Phosphokinase Increased Health Panangin C Muscle Rigidity Professional Diaphyllin C Neuroleptic Malignant Company Syndrome Representative Date:06/16/98ISR Number: 3095142-XReport Type:Expedited (15-DaCompany Report #US_980503862 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alcohol Increased Health Zyprexa PS 100 MG/DAY Initial or Prolonged Blood Creatine Professional Captopril C Phosphokinase Increased Hydrochlorothiazide C Blood Lactate Dehydrogenase Increased Chest Pain Convulsion Facial Palsy Fall Hypotonia Intentional Misuse Liver Function Test Abnormal Loss Of Consciousness Mental Impairment Pupillary Light Reflex Tests Abnormal Respiratory Rate Decreased Sedation Date:06/16/98ISR Number: 3095143-1Report Type:Expedited (15-DaCompany Report #US_980300869 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Zyprexa PS 20 MG/1 DAY Initial or Prolonged Oedema Professional Risperidone C Weight Increased Lasix C Dilaudid C Desipramine C Valium C Lansoprazole C Naproxen C Zoloft C Trazodone C Ambien C Asa C Date:06/16/98ISR Number: 3095186-8Report Type:Expedited (15-DaCompany Report #98GB-10553 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Carbamazepine PS 800 MG, DAILY Initial or Prolonged Epilepsy Health Zyprexa SS Hyponatraemia Professional 24-Jun-2005 12:19 PM Page: 350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/98ISR Number: 3095195-9Report Type:Expedited (15-DaCompany Report #GBS980400386 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Bone Marrow Depression Health Flupentixol C Drug Ineffective Professional Amoxycillin C Ecchymosis Other Haemoglobin Decreased Neutrophil Count Decreased Platelet Count Decreased Reticulocyte Count Decreased White Blood Cell Count Decreased Date:06/16/98ISR Number: 3095199-6Report Type:Expedited (15-DaCompany Report #EWC980300103 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS 20 MG/DAY Hospitalization - Health Neurocil C Initial or Prolonged Professional Acc Long (Acetylcysteine) C Bronchoretard C Decortin-H C Pulmicort C Serevent C Date:06/17/98ISR Number: 3095220-5Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Zyprexa PS ORAL 10MG HS Fatigue ORALLY Hyperhidrosis Lithium C Tegretol C Lorazepam C Ativan C Mom C Dss C Date:06/18/98ISR Number: 3095148-0Report Type:Expedited (15-DaCompany Report #US_980402314 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Embolism Health Zyprexa PS 10 MG/1 DAY 1 YR Professional Coumadin C Heparin C Date:06/18/98ISR Number: 3097435-9Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Zyprexa PS 10MG DAILY Initial or Prolonged Thrombocytopenia Lodine SS 4 WK Buspirone C 24-Jun-2005 12:19 PM Page: 351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Antibiotics C Date:06/19/98ISR Number: 3096989-6Report Type:Expedited (15-DaCompany Report #F/98/01273/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Leponex PS ORAL ORAL Initial or Prolonged Dyskinesia Professional Zyprexa SS Extrapyramidal Disorder Hyperhidrosis Pneumonia Productive Cough Date:06/22/98ISR Number: 3097185-9Report Type:Expedited (15-DaCompany Report #100632 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Health Diazepam PS ORAL 30 MG DAILY Initial or Prolonged Professional ORAL Other Zyprexia SS ORAL 5 MG DAILY ORAL Paxil SS ORAL 20 MG DAILY ORAL Lithium SS ORAL 600 MG 2 X PER DAY ORAL Vistaril SS ORAL ORAL Triazolam SS ORAL ORAL Tegretol SS ORAL 400 MG DAILY ORAL Serzone C ORAL 250 MG DAILY ORAL Date:06/23/98ISR Number: 3098141-7Report Type:Expedited (15-DaCompany Report #1998AP46398 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Clozapine PS 1 MON Life-Threatening Tachycardia Health Seroquel SS Professional Olanzapine SS Aspirin "Bayer" C Sodium Valproate C Digoxin C Fybogel C Date:06/24/98ISR Number: 3097782-0Report Type:Expedited (15-DaCompany Report #GBS980600636 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa PS 15 MG Health Carbamazepine C 400 MG Professional Fluphenazine Company Decanoate C 80 MG Representative Paroxetine C 20MG Procyclidine C 5MG Zopiclone C 7.5MG 24-Jun-2005 12:19 PM Page: 352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/98ISR Number: 3097783-2Report Type:Expedited (15-DaCompany Report #GBS980600635 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS UNK Health Sertraline C ORAL 50 MG Professional Company Representative Date:06/24/98ISR Number: 3097784-4Report Type:Expedited (15-DaCompany Report #US 980300799 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Health Zyprexa PS Exposure To Therapeutic Professional Multiple Vitamins C Drugs Intra-Uterine Death Premature Rupture Of Membranes Date:06/24/98ISR Number: 3097785-6Report Type:Expedited (15-DaCompany Report #GBS980600666 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS 10 MG Myocarditis Health Fybogel C ORAL Tachycardia Professional Other Date:06/24/98ISR Number: 3097787-XReport Type:Expedited (15-DaCompany Report #US 980604306 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Zyprexa PS 10 MG Hospitalization - Hepatitis B Professional Desyrel C ORAL 50 MG Initial or Prolonged Prothrombin Time Company Prolonged Representative Date:06/24/98ISR Number: 3097788-1Report Type:Expedited (15-DaCompany Report #US 980503913 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Zyprexa PS 5 MG Initial or Prolonged Professional Ms 6/17/98 SS 60 MG Company Wellbutrin C 75 MG Representative Date:06/24/98ISR Number: 3097821-7Report Type:Expedited (15-DaCompany Report #GBS 980500581 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intermittent Claudication Foreign Zyprexa PS 15 MG/1 DAY Initial or Prolonged Myocardial Infarction Health Flupentixol C Other Peripheral Vascular Professional Procyclidine C Disorder Company Representative 24-Jun-2005 12:19 PM Page: 353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/98ISR Number: 3097831-XReport Type:Expedited (15-DaCompany Report #US 980300577 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Zyprexa PS 5 MG/DAY Initial or Prolonged Drug Abuser Professional Fentanyl C Face Oedema Joint Swelling Oedema Pyrexia Weight Increased Date:06/24/98ISR Number: 3097989-2Report Type:Expedited (15-DaCompany Report #GBS980600705 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Health Professional Company Representative Date:06/24/98ISR Number: 3097992-2Report Type:Expedited (15-DaCompany Report #EWC980600883 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS 2 MONTHS 2 MON Initial or Prolonged Medication Error Consumer Psychotic Disorder Other Date:06/24/98ISR Number: 3097995-8Report Type:Expedited (15-DaCompany Report #GBS980600707 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Health Professional Company Representative Other Date:06/24/98ISR Number: 3097997-1Report Type:Expedited (15-DaCompany Report #GBS980600695 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Foreign Zyprexa PS Initial or Prolonged Drug Ineffective Health Flupentixol Paranoia Professional Decanoate C Suicidal Ideation Other Date:06/24/98ISR Number: 3097998-3Report Type:Expedited (15-DaCompany Report #DE_980600114 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Leukopenia Foreign Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS 30MG DAY Date:06/24/98ISR Number: 3098006-0Report Type:Expedited (15-DaCompany Report #US97093742A Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Zyprexa PS Brain Oedema Professional Cogentin C Completed Suicide Glucotrol C Intentional Misuse Date:06/25/98ISR Number: 3097732-7Report Type:Expedited (15-DaCompany Report #EWC980500705 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS 5 MG/DAY Initial or Prolonged Oedema Peripheral Health Ataraz ( Hydroxyzine Professional Hydrochloride) C Other Heminevrin (Clomethiazole Edisilate) C Behepan (Cyanocobalamin) C Ventoline (Salbutamol) C Atrovent (Ipratrpium Bromide) C Losec (Oemprazole) C Efexor (Venlafaxine Hydrochloride) C Date:06/25/98ISR Number: 3098746-3Report Type:Expedited (15-DaCompany Report #S/98/00059/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Leponex PS ORAL 150 MG ORAL Initial or Prolonged Atelectasis Stesolid SS ORAL 15 MG ORAL Required C-Reactive Protein Clomipramine SS ORAL 100 MG ORAL Intervention to Increased Zyprexa SS ORAL 15 MG ORAL Prevent Permanent Cold Sweat Diuretic C Impairment/Damage Condition Aggravated Dermatitis Ejection Fraction Abnormal Eosinophilia Eosinophilic Pneumonia Hyperhidrosis Hypertension Oedema Pleural Effusion Stress 24-Jun-2005 12:19 PM Page: 355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/98ISR Number: 3099539-3Report Type:Expedited (15-DaCompany Report #GBS980500590 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Procyclidine C Date:06/29/98ISR Number: 3099541-1Report Type:Expedited (15-DaCompany Report #US_980300331 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Foreign Zyprexa PS 5 MG/1 DAY Initial or Prolonged Intestinal Obstruction Study Modopar C Megacolon Health Hept-A-Myl Weight Decreased Professional (Heptaminol Hydrochloride) C Rythmodan (Disopyramide) C Aspegic (Acetylsalicylate Lysine) C Equanil (Meprobamate) C Lubentyl(Paraffin Liquid) C Liquid Paraffin And Magnesium Hydroxide C Peristaltine (Cascara Dry Extract) C Date:06/29/98ISR Number: 3099542-3Report Type:Expedited (15-DaCompany Report #DE_980600114 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Foreign Zyprexa PS 30 MG DAY Abnormal Health Atosil C Leukopenia Professional Date:06/29/98ISR Number: 3099544-7Report Type:Expedited (15-DaCompany Report #EWC980400445 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa PS 20 MG/DAY Hospitalization - Hyperglycaemia Health Initial or Prolonged Respiratory Disorder Professional Date:06/29/98ISR Number: 3100127-0Report Type:Expedited (15-DaCompany Report #EWC980600900 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Balance Disorder Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Brain Oedema Health Levomepromazine C Initial or Prolonged Hyponatraemia Professional Procyclidine C Loss Of Consciousness 24-Jun-2005 12:19 PM Page: 356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/98ISR Number: 3100130-0Report Type:Expedited (15-DaCompany Report #GBS980600666 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa (Olanzapine) PS 10 MG/2 DAY Myocarditis Health Fybogel (Ispaghula) C Tachycardia Professional Aspirin C Other Date:06/29/98ISR Number: 3100131-2Report Type:Expedited (15-DaCompany Report #CA-980600034 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Zyprexa (Olanzapine) PS Bronchospasm Health Tegretol Dyspnoea Exertional Professional (Carbamazepine) C Myocardial Infarction Becloforte Weight Increased (Beclometasone Dipropionate) C Adalat (Nifedipine) C Ventolin (Salbutamol) C Ventolin (Salbutamol) C Date:06/29/98ISR Number: 3100134-8Report Type:Expedited (15-DaCompany Report #GBS980600764 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa (Olanzapine) PS 15 MG DAY Initial or Prolonged Electroencephalogram Health Abnormal Professional Sedation Other Date:06/29/98ISR Number: 3100429-8Report Type:Expedited (15-DaCompany Report #US_980605685 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Supraventricular Foreign Zyprexa PS 20 MG/DAY Tachycardia Health Professional Company Representative Other Date:06/29/98ISR Number: 3100430-4Report Type:Expedited (15-DaCompany Report #US_98605559 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Zyprexa PS 2.5 MG / DAY 30 DAY Other Professional Prolixin Decanoate Other (Fluphenazine Decanotae) C 24-Jun-2005 12:19 PM Page: 357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/98ISR Number: 3100432-8Report Type:Expedited (15-DaCompany Report #US_980300132 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS Initial or Prolonged Intentional Misuse Health Rivotril Professional (Clonazepam) C Other Paxil (Paroxetine Hydrochloride) C Date:06/29/98ISR Number: 3100434-1Report Type:Expedited (15-DaCompany Report #US_98060558 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Other Professional Risperdal(Risperidon e) C Date:06/29/98ISR Number: 3100436-5Report Type:Expedited (15-DaCompany Report #EWC980600926 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged C-Reactive Protein Health Stesolid C Increased Professional Leponex C Cardiac Failure Other Clomipramine C Catecholamines Urine Loracarbef C Increased Doxyferm C Cold Sweat Dermatitis Dyspnoea Ejection Fraction Abnormal Eosinophilia Hypertension Hypokinesia Lung Consolidation Oedema Pleural Effusion Upper Respiratory Tract Infection Date:06/29/98ISR Number: 3100437-7Report Type:Expedited (15-DaCompany Report #EWC980600931 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zyprexa PS 20 MG/DAY Initial or Prolonged Urticaria Health Lorazepam C Professional Flurazepam C Other Date:06/30/98ISR Number: 3100027-6Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Zyprexa PS ORAL 10MG QHS PO Date:06/30/98ISR Number: 3100123-3Report Type:Expedited (15-DaCompany Report #100632 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Health Diazepam PS ORAL 30 MG DAILY Initial or Prolonged Blood Cholesterol Professional ORAL Increased Other Zyprexa SS ORAL 5 MG DAILY Diabetes Mellitus ORAL Hyperlipidaemia Paxil SS ORAL 20 MG DAILY ORAL Lithium SS ORAL 600 MG 2 X PER DAY ORAL Tegretol SS ORAL 400 MG DAILY ORAL Serzone SS ORAL 250 MG DAILY ORAL Triazolam SS ORAL ORAL Vistaril SS ORAL ORAL Date:07/06/98ISR Number: 3101883-8Report Type:Expedited (15-DaCompany Report #GBS980600855 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa PS Health Cyclosporin C Professional Prednisolone C Other Aspirin C Date:07/06/98ISR Number: 3101885-1Report Type:Expedited (15-DaCompany Report #US_980605686 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Health Zyprexa PS 10 MG/DAY Initial or Prolonged Thrombocytopenia Professional Lodine C Other Buspar (Buspirone Hydrochloride) C Date:07/06/98ISR Number: 3101892-9Report Type:Expedited (15-DaCompany Report #GBS980600843 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Foreign Zyprexa PS 10 MG/1 DAY Initial or Prolonged Mania Health Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/98ISR Number: 3101893-0Report Type:Expedited (15-DaCompany Report #GBS980600847 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Health Professional Company Representative Other Date:07/06/98ISR Number: 3101942-XReport Type:Expedited (15-DaCompany Report #DE_980600114 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Foreign Zyprexa PS 30 MG DAY Abnormal Health Atosil C Leukopenia Professional Date:07/06/98ISR Number: 3101944-3Report Type:Expedited (15-DaCompany Report #GBS980600695 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Foreign Zyprexa PS Initial or Prolonged Drug Ineffective Health Flupentixol C Paranoia Professional Procyclidine C Suicidal Ideation Haloperidol C Date:07/06/98ISR Number: 3101966-2Report Type:Expedited (15-DaCompany Report #EWC_980600956 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS 10 MG/ DAY Health Urbanyl C Professional Rohypnol C Company Modecate C Representative Date:07/06/98ISR Number: 3101978-9Report Type:Expedited (15-DaCompany Report #EWC 980300117 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS ORAL 20 MG DAY Health Laroxyl C Professional Tranxene C Duphalac C Date:07/06/98ISR Number: 3101982-0Report Type:Expedited (15-DaCompany Report #EWC 980400434 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Exacerbated Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Pulmonary Hypertension Health Zuclopenthixol C Professional Flufenazin C 24-Jun-2005 12:19 PM Page: 360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/98ISR Number: 3101987-XReport Type:Expedited (15-DaCompany Report #EWC980400442 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Zyprexa PS 20 MG/ DAY Initial or Prolonged Drug Withdrawal Syndrome Health Haldol C Hostility Professional Intentional Self-Injury Company Mania Representative Date:07/06/98ISR Number: 3102410-1Report Type:Expedited (15-DaCompany Report #AU_980600069 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Zyprexa PS 5 MG / 1 DAY Initial or Prolonged Blood Pressure Increased Health Labetalol C Complication Of Delivery Professional Stelazine C Pre-Eclampsia Umbilical Cord Around Neck Date:07/06/98ISR Number: 3102411-3Report Type:Expedited (15-DaCompany Report #CA_980500015 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa PS 1500 MG/ 1 Initial or Prolonged Date:07/06/98ISR Number: 3102412-5Report Type:Expedited (15-DaCompany Report #EWC 980600969 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Zyprexa PS 10 MG/ DAY 3 MON Intestinal Obstruction Health Venflaxine C Professional Company Representative Date:07/06/98ISR Number: 3102413-7Report Type:Expedited (15-DaCompany Report #US_980605716 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ammonia Increased Health Zyprexa PS 5 MG/ DAY Confusional State Professional Remeron C Disorientation Senokot C Hepatic Encephalopathy Date:07/06/98ISR Number: 3102414-9Report Type:Expedited (15-DaCompany Report #US_980605773 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Initial or Prolonged Phosphokinase Increased Professional Haldol C Haematemesis Depakote C Laboratory Test Abnormal Cogentin C Nausea Lamisil C Vomiting Maalox C 24-Jun-2005 12:19 PM Page: 361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Preparation H C Date:07/06/98ISR Number: 3102415-0Report Type:Expedited (15-DaCompany Report #US 980606105 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Zyprexa PS 5 MG/ DAY Professional Lamivudine C Acyclovir C Stavudine C Date:07/06/98ISR Number: 3103995-1Report Type:Direct Company Report # Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Zyprexa PS 5 MG QD Initial or Prolonged Confusional State Tylenol C Dehydration Ativan C Hypotension Lasix C Zaroxolyn C K-Dur C Folvile C Atrovent C Meclizine C Prednisone C Prilosec C Allopurinel C Isoptin C Pravachol C Digoxin C Rheumatrex C Ca Co3 C Serevent C Date:07/06/98ISR Number: 3104039-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS 10MG DAILY Zyprexa SS 10MG DAILY Date:07/07/98ISR Number: 3104004-0Report Type:Direct Company Report # Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Olanzapine PS ORAL 2.5 MG PO BID Initial or Prolonged Hallucination Digoxin C Joint Stiffness Kce Er C Paranoia Pramipexole C Sinemet C Furosemide C 24-Jun-2005 12:19 PM Page: 362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/98ISR Number: 3104072-6Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Face Oedema Olanzapine PS HS Intervention to Rash Maculo-Papular Bupropin SS HS Prevent Permanent Impairment/Damage Date:07/08/98ISR Number: 3103669-7Report Type:Expedited (15-DaCompany Report #M082780 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Serzone PS ORAL 150 MG BID Initial or Prolonged Professional ORAL 1 YR Disability Zyprexa SS ORAL 5 MG OHS ORAL 1 YR Date:07/08/98ISR Number: 3103918-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Olanzapine PS 7.5 QD 9 MON Atorvastatin C Levothyroxine C Li Co-3 C Ativan C Motrin C Mylanta C Date:07/10/98ISR Number: 3108752-8Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Pain Zyprexa PS ONE PER DAY Convulsion Fatigue Muscle Spasms Myalgia Date:07/13/98ISR Number: 3105260-5Report Type:Expedited (15-DaCompany Report #US_980605881 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Confusional State Health Paroxetine C Dysphagia Professional Sinemet C Fall Other Metoprolol C Femur Fracture Tolcapone C Gait Disturbance Vitamin B12 C Hallucination Parkinson'S Disease Pyrexia 24-Jun-2005 12:19 PM Page: 363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/98ISR Number: 3105261-7Report Type:Expedited (15-DaCompany Report #US_980605970 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Health Zyprexa PS Professional Date:07/14/98ISR Number: 3104797-2Report Type:Expedited (15-DaCompany Report #GBS980600846 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyporeflexia Foreign Zyprexa PS 20 MG DAY Initial or Prolonged Platelet Count Decreased Health Chlorpromazine C Sensory Loss Professional Lofepramine C Pipotiazine Palmitaate C Propranolol C Date:07/14/98ISR Number: 3104800-XReport Type:Expedited (15-DaCompany Report #DE97093025A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Abnormal Health Grand Mal Convulsion Professional Date:07/14/98ISR Number: 3104802-3Report Type:Expedited (15-DaCompany Report #CA_980600053 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Overdose Health Professional Date:07/14/98ISR Number: 3104805-9Report Type:Expedited (15-DaCompany Report #EWC980400347 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS 10 MG/DAY Life-Threatening Cardio-Respiratory Arrest Health Axil (Pidotimod) C Hospitalization - Coma Professional Seduxen (Diazepam) C Initial or Prolonged Company Representative Date:07/14/98ISR Number: 3104806-0Report Type:Expedited (15-DaCompany Report #US98023757A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Consumer Zyprexa PS UNKNOWN 15 MG DAY Initial or Prolonged Phosphokinase Increased Health UNKNOWN 7 MON Coma Professional Doxepin C Hepatic Failure Paxil C Hepatocellular Damage Cogentin C Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3104809-6Report Type:Expedited (15-DaCompany Report #GBS980700924 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Foreign Zyprexa PS UNKNOWN 20 MG UNKNOWN Abnormal Health Carbamazepine C Hypothyroidism Professional Medication Error Date:07/14/98ISR Number: 3104831-XReport Type:Expedited (15-DaCompany Report #GBS980700927 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa PS UNKNOWN 20 MG DAY Hypothyroidism Health UNKNOWN Professional Lithium C Company Representative Date:07/14/98ISR Number: 3104835-7Report Type:Expedited (15-DaCompany Report #GBS980700903 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myeloid Leukaemia Foreign Zyprexa PS UNKNOWN 10 MG 1 DAY Initial or Prolonged Health UNKNOWN Professional Fluoxetine C Date:07/14/98ISR Number: 3104838-2Report Type:Expedited (15-DaCompany Report #US_980606184 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS UNKNOWN 300 MG DAY Initial or Prolonged Aspiration Professional UNKNOWN Blood Ethanol Increased Lithium C Depressed Level Of Sertraline C Consciousness Lung Infiltration Overdose Therapeutic Agent Toxicity Date:07/14/98ISR Number: 3104840-0Report Type:Expedited (15-DaCompany Report #US_980606172 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Zyprexa PS UNKNOWN 40 MG DAY Therapeutic Agent Professional UNKNOWN Toxicity Navane C Vomiting Neurontin C Depakote C Date:07/14/98ISR Number: 3104843-6Report Type:Expedited (15-DaCompany Report #US_980706261 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Zyprexa PS UNKNOWN 5 MG DAY Professional UNKNOWN 1 WK 24-Jun-2005 12:19 PM Page: 365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin C Premarin C Date:07/14/98ISR Number: 3104845-XReport Type:Expedited (15-DaCompany Report #US_980706299 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Consumer Zyprexa PS UNKNOWN 10 MG 1 DAY Initial or Prolonged Libido Decreased UNKNOWN Weight Increased Date:07/14/98ISR Number: 3104853-9Report Type:Expedited (15-DaCompany Report #GBS980700925 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Foreign Zyprexa PS UNKNOWN 10 MG DAY Health UNKNOWNS Professional Warfarin C Date:07/14/98ISR Number: 3104933-8Report Type:Expedited (15-DaCompany Report #US_980604306 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Zyprexa PS 10 MG/1 DAY 1 YR Hospitalization - Hepatitis B Professional Desyrel C Initial or Prolonged Infection Company Prothrombin Time Representative Prolonged Date:07/14/98ISR Number: 3105136-3Report Type:Expedited (15-DaCompany Report #GBS980600695 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS 20 MG DAY Initial or Prolonged Disturbance In Attention Health Flupentixol Drug Ineffective Professional Decanoate C Irritability Procyclidine C Paranoia Suicidal Ideation Date:07/14/98ISR Number: 3105139-9Report Type:Expedited (15-DaCompany Report #GBS980600637 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Zyprexa PS Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3105142-9Report Type:Expedited (15-DaCompany Report #GBS980600843 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS 15 MG/1 DAY Initial or Prolonged Health Zuclopenthixol C Professional Company Representative Date:07/14/98ISR Number: 3105147-8Report Type:Expedited (15-DaCompany Report #GBS980500603 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa PS Circulatory Collapse Health Depixol C Professional Sulpiride C Company Representative Other Date:07/14/98ISR Number: 3105149-1Report Type:Expedited (15-DaCompany Report #US_980503700 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Bilirubin Increased Health Zyprexa PS 10 MG/1 DAY 1 YR Hospitalization - Hepatic Encephalopathy Professional Trazodone C Initial or Prolonged Hepatic Failure Company Hepatitis B Representative Jaundice Prothrombin Time Prolonged Date:07/14/98ISR Number: 3108201-XReport Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Zyprexa PS ORAL 5 MG PO 3 MON Tegretol SS ORAL 800 MG PO 3 MON Gabapentin C Date:07/14/98ISR Number: 3108255-0Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Health Zyprexa PS ORAL 20MG,PO 2 MON Professional Tegretol SS UNKNOWN 600MG 2 MON Insulin C Navane C Synthroid C Date:07/15/98ISR Number: 3105591-9Report Type:Expedited (15-DaCompany Report #US97121714A Age:43 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Alcohol Increased 24-Jun-2005 12:19 PM Page: 367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Creatine Phosphokinase Mb Increased Report Source Product Role Manufacturer Route Dose Duration Coma Consumer Zyprexa PS 10 MG/ 1 Delirium Health DAY Dysarthria Professional Effexor (Venlafaxine Hostility Company Hydrochloride) C Miosis Representative Klonopin Pupil Fixed (Clonazepam) C Renal Failure Acute Trazodone C Rhabdomyolysis Ambien (Zolpidem Sinus Tachycardia Tartrate) C Stupor Suicidal Ideation Thinking Abnormal Date:07/15/98ISR Number: 3108268-9Report Type:Direct Company Report # Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Zyprexa PS Lilly Date:07/16/98ISR Number: 3105885-7Report Type:Expedited (15-DaCompany Report #980701-008012345 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Haldol PS ORAL 45 MG, ORAL Initial or Prolonged Depressed Level Of Health Doxepin SS ORAL 1.7 G, ORAL Other Consciousness Professional Perazine SS ORAL 600 MG, ORAL Overdose Olanzapine SS ORAL 20 MG, ORAL Fluoxetine SS ORAL 60 MG, ORAL Date:07/17/98ISR Number: 3108241-0Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Zyprexa PS Lilly ORAL 5 MG HS PO Tongue Disorder Ambien C Date:07/20/98ISR Number: 3106732-XReport Type:Expedited (15-DaCompany Report #US_980401282 Age:40 YR Gender:Male I/FU:F Outcome PT Death Bacteria Sputum Life-Threatening Identified Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Cardiac Arrest Chest Pain Clostridium Colitis Condition Aggravated Coronary Artery Disease Embolism Hyperkalaemia Intestinal Ischaemia Lactic Acidosis Metabolic Disorder 24-Jun-2005 12:19 PM Page: 368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pneumonia Report Source Product Role Manufacturer Route Dose Duration Post Procedural Health Zyprexa PS 40 MG/DAY Complication Professional Vancomycin SS Pulmonary Infarction Other Serzone C Pyrexia Amantadine C Renal Failure Synthroid C Renal Impairment Ativan C Bentyl C Date:07/20/98ISR Number: 3107062-2Report Type:Expedited (15-DaCompany Report #DE_980700176 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Hepatic Steatosis Health Tavor C Professional Date:07/20/98ISR Number: 3107064-6Report Type:Expedited (15-DaCompany Report #DE_980700178 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Health Zyprexa SS 20 MG DAY Professional Haldol C Date:07/20/98ISR Number: 3107150-0Report Type:Expedited (15-DaCompany Report #US_980504112 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Zyprexa PS 10 MG/DAY 2 WK Drug Abuser Professional Albuterol C Dyspnoea Cocaine C Overdose Date:07/20/98ISR Number: 3107152-4Report Type:Expedited (15-DaCompany Report #US-980503700 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Encephalopathy Health Zyprexa PS 10 MG/1 DAY Hospitalization - Hepatic Failure Professional Trazodone C Initial or Prolonged Hepatitis B Company Prozac (Fluoxetine Hyperbilirubinaemia Representative Hydrochloride) C Jaundice Prothrombin Time Prolonged Date:07/20/98ISR Number: 3107153-6Report Type:Expedited (15-DaCompany Report #US_980605716 Age:88 YR Gender:Male I/FU:F Outcome PT Hospitalization - Ammonia Increased Initial or Prolonged Blood Urea Increased Other Confusional State Depressed Level Of 24-Jun-2005 12:19 PM Page: 369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Disorientation Hepatic Encephalopathy Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 5 MG/DAY Professional Remeron (Mirtazapine) C Senokot (Senna Fruit) C Date:07/20/98ISR Number: 3107154-8Report Type:Expedited (15-DaCompany Report #EWC980400346 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 10 MG/DAY Health Professional Date:07/20/98ISR Number: 3107155-XReport Type:Expedited (15-DaCompany Report #DE97093025A Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Zyprexa PS 10 MG DAY 6 MON Initial or Prolonged Abnormal Health Grand Mal Convulsion Professional Date:07/20/98ISR Number: 3107156-1Report Type:Expedited (15-DaCompany Report #GBS980600855 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa PS Coronary Artery Disease Health Cyclosporin A C Professional Prednisolone C Aspirin C Amlodipine C Ranitidine C Date:07/20/98ISR Number: 3107179-2Report Type:Expedited (15-DaCompany Report #US 980706629 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS 5 MG/1 DAY 1 MON Initial or Prolonged Csf Pressure Increased Professional Ritalin Encephalitis (Methylphenidate Grand Mal Convulsion Hydrochloride) C Headache Adderall C Irritability Depakote (Valproate Middle Insomnia Semisodium) C Migraine Lithium C Date:07/20/98ISR Number: 3107180-9Report Type:Expedited (15-DaCompany Report #US 980706523 Age:32 YR Gender:Female I/FU:I Outcome PT Other Balance Disorder Dysarthria Dystonia 24-Jun-2005 12:19 PM Page: 370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Sedation Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS UNKNOWN 200 MG/DAY Health Professional Date:07/20/98ISR Number: 3107181-0Report Type:Expedited (15-DaCompany Report #USA 980706543 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa PS UNKNOWN 150 MG Initial or Prolonged Overdose Health Suicide Attempt Professional Date:07/20/98ISR Number: 3107182-2Report Type:Expedited (15-DaCompany Report #US_980706557 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Olanzapine PS UNKNOWN 135 MG/DAY Initial or Prolonged Hallucination, Auditory Health Other Overdose Professional Persecutory Delusion Suicide Attempt Date:07/20/98ISR Number: 3107183-4Report Type:Expedited (15-DaCompany Report #US 980706540 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS UNKNOWN UNK 6 MON Professional Company Representative Date:07/20/98ISR Number: 3107184-6Report Type:Expedited (15-DaCompany Report #US 980401685 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Zyprexa PS UNKNOWN 10 MG/1DAY 1 MON Convulsion Professional Mirapex (Mirapex) C Overdose Company Mellaril Urinary Tract Disorder Representative (Thioridazine Hydrochloride) C Date:07/20/98ISR Number: 3107185-8Report Type:Expedited (15-DaCompany Report #US98030394A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS UNKNOWN 5 MG/ 1 DAY Initial or Prolonged Atrial Fibrillation Professional Coumadin (Warfarin Other Heart Rate Increased Other Sodium) C Lactic Acidosis Lanoxin (Digoxin) C Muscle Rigidity Calan Sr (Verapamil Neuroleptic Malignant Hydrochloride) C Syndrome Valium (Diazepam) C Pyrexia 24-Jun-2005 12:19 PM Page: 371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/98ISR Number: 3107186-XReport Type:Expedited (15-DaCompany Report #GBS980700955 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Analgesic Drug Level Foreign Zyprexa PS UNKNOWN 10 M/1 DAY Initial or Prolonged Above Therapeutic Health Paracetamol C Brain Oedema Professional Ferrous Sulphate C Cardiac Arrest Cardiac Failure Circulatory Collapse Convulsion Drug Level Below Therapeutic Electrocardiogram Qt Prolonged Headache Hepatic Function Abnormal Nervous System Disorder Overdose Prothrombin Time Shortened Pulse Absent Pupil Fixed Pyrexia Renal Failure Respiratory Arrest Date:07/20/98ISR Number: 3107187-1Report Type:Expedited (15-DaCompany Report #GBS 980700950 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Foreign Zyprexa PS UNKNOWN 20 MG/ 1 DAY Pneumonia Health Enalapril C Professional Diltiazem C Isosorbide Mononitrate C Atenolol C Doxazosin C Aspirin C Indapamide C Date:07/20/98ISR Number: 3107188-3Report Type:Expedited (15-DaCompany Report #EWC 980701054 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anorexia Foreign Zyprexa PS UNKNOWN 10 MG/DAY Asocial Behaviour Cisordinol Fatigue (Clopenthixol Obsessive-Compulsive Hydrocholride) C Disorder Date:07/20/98ISR Number: 3107189-5Report Type:Expedited (15-DaCompany Report #EWC 980701058 Age:22 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Condition Aggravated Constipation Large Intestinal 24-Jun-2005 12:19 PM Page: 372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obstruction Megacolon Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS UNKNOWN 20 MG/DAY Health Tranxene Professional (Clorazepate Dipotassium) C Loxapac (Loxapine Succinate) C Imovane (Zopiclone) C Date:07/20/98ISR Number: 3107190-1Report Type:Expedited (15-DaCompany Report #EWC 980701041 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericardial Effusion Foreign Zyprexa PS UNKNOWN 20 MG/DAY Health Temesta (Lorazepam) C Professional Date:07/20/98ISR Number: 3107191-3Report Type:Expedited (15-DaCompany Report #CA 980700064 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Zyprexa PS UNKNOWN 150 MG Hospitalization - Hyperthermia Malignant Health Nytol C Initial or Prolonged Intentional Misuse Professional Mogadon (Nitrazepam) C Date:07/20/98ISR Number: 3109628-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chorea Olanzapine PS ORAL 7.5MG 2 PO Intervention to Dyskinesia QHS Prevent Permanent Tardive Dyskinesia Didanosine C 100 MG 2 PO Impairment/Damage BID Nelfinavir C 250 MG 3 PO TID Zidovudine C 300 MG 1 PO BID Benztropine C 1MG 1 PO BID Date:07/21/98ISR Number: 3108470-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Olanzapine PS 1 Q AM; 2 Q HS 6 DAY Depakote C Date:07/22/98ISR Number: 3108373-7Report Type:Expedited (15-DaCompany Report #8-98189-001C Age:50 YR Gender:Male I/FU:I Outcome PT Hospitalization - Hepatic Steatosis Initial or Prolonged Hepatitis Liver Function Test 24-Jun-2005 12:19 PM Page: 373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Tavor PS ORAL 2 MG ONCE Study DAILY Zyprexa SS ORAL 10 MG DAILY Date:07/23/98ISR Number: 3107684-9Report Type:Expedited (15-DaCompany Report #US9830 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Adderall 10 PS 15 MG @7&11 Initial or Prolonged Coma 10MG @ 3 1 WK Confusional State Depakote SS Convulsion Zyprexa SS Crying Csf Test Abnormal Electrocardiogram Abnormal Electroencephalogram Abnormal Headache Migraine Respiration Abnormal Screaming Date:07/23/98ISR Number: 3107804-6Report Type:Expedited (15-DaCompany Report #A0067257 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Auricular Swelling Health Wellbutrin PS ORAL ORAL Initial or Prolonged Blood Pressure Increased Professional Dexamphetamine SS ORAL ORAL Blood Thyroid Stimulating Company Olanzapine SS ORAL ORAL Hormone Decreased Representative Hyperglycaemia Hypersensitivity Leukocytosis Pruritus Rash Maculo-Papular Tachycardia Date:07/23/98ISR Number: 3107885-XReport Type:Expedited (15-DaCompany Report #WAES 98075129 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Foreign Vasotec PS ORAL 40 MG PO Life-Threatening Pneumonia Health Olanzapine SS ORAL 20 MG PO Hospitalization - Professional Aspirin C Initial or Prolonged Atenolol C Diltiazem C Doxazosin C Indapamide C Isosorbide-5-Mononit rate C 24-Jun-2005 12:19 PM Page: 374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/98ISR Number: 3109709-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Zyprexa PS Eli Lilly 40 MG / DAY Insomnia Date:07/27/98ISR Number: 3109121-7Report Type:Expedited (15-DaCompany Report #US_980604766 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa PS 5 MG/ 2 DAY 1 MON Professional Pamelor C Elavil C Date:07/27/98ISR Number: 3109123-0Report Type:Expedited (15-DaCompany Report #US_980605558 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Zyprexa PS 30 MG/DAY Coma Professional Risperdal C Drug Level Above Clonazepam C Therapeutic Vomiting Date:07/27/98ISR Number: 3109125-4Report Type:Expedited (15-DaCompany Report #US_980706629 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amphetamines Positive Health Zyprexa PS 5 MG/ 1 DAY 1 MON Initial or Prolonged Coma Professional Ritalin C Grand Mal Convulsion Aderall C Headache Depakote C Irritability Lithium C Middle Insomnia Migraine Date:07/27/98ISR Number: 3109128-XReport Type:Expedited (15-DaCompany Report #GBS 980700955 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Foreign Zyprexa PS 10 MG/1 DAY Life-Threatening Brain Oedema Health Paracetamol C Hospitalization - Cardiac Arrest Professional Ferruous Sulphate C Initial or Prolonged Cardiac Failure Circulatory Collapse Convulsion Drug Level Below Therapeutic Electrocardiogram Qt Prolonged Headache Liver Function Test Abnormal Overdose Pupil Fixed Pyrexia Respiratory Arrest 24-Jun-2005 12:19 PM Page: 375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/98ISR Number: 3109157-6Report Type:Expedited (15-DaCompany Report #CA_980700073 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS ORAL 10 MG/3 DAY Hospitalization - Chest Wall Pain Health Enalapril C Initial or Prolonged Coronary Artery Disease Professional Benzotropine Dyspnoea (Benzatropine Muscle Twitching Mesilate) C Myocardial Infarction Nozinan C Myocardial Ischaemia Date:07/27/98ISR Number: 3109159-XReport Type:Expedited (15-DaCompany Report #US_980706984 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine PS Health Sulpiride C Professional Other Date:07/27/98ISR Number: 3109161-8Report Type:Expedited (15-DaCompany Report #US_980707059 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Zyprexa PS 5 MG/DAY 1 WK Dyspnoea Professional Cardizem C Tachycardia Prinivil C Restoril C Date:07/27/98ISR Number: 3109164-3Report Type:Expedited (15-DaCompany Report #US_980707097 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis A Health Zyprexa PS ORAL 20MG/DAY 5 MON Hepatitis B Professional Depakote C Hepatitis C Neurontin C Liver Function Test Abnormal Date:07/27/98ISR Number: 3109166-7Report Type:Expedited (15-DaCompany Report #EWC980400342 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Zyprexa PS 20MG DAY Hospitalization - Health Truxal C Initial or Prolonged Professional Haldol C Date:07/27/98ISR Number: 3109168-0Report Type:Expedited (15-DaCompany Report #EWC980701089 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Foreign Zyprexa PS 15MG DAY Hospitalization - Hypovolaemic Shock Health Voltarene C Initial or Prolonged Intestinal Obstruction Professional Vomiting Other 24-Jun-2005 12:19 PM Page: 376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/98ISR Number: 3109170-9Report Type:Expedited (15-DaCompany Report #GBS980700952 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS 15MG/1DAY Leukopenia Health Carbamazepine C Professional Date:07/27/98ISR Number: 3109172-2Report Type:Expedited (15-DaCompany Report #GSB980701039 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Foreign Zyprexa PS 20MG DAY Depressed Mood Health Amitriptyline C Grandiosity Professional Date:07/27/98ISR Number: 3109175-8Report Type:Expedited (15-DaCompany Report #GBS980701030 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zyprexa PS 100MG DAY Health Neurontin C Professional Camcolit C Other Epilim Chrono C Dolmatil C Liothyroninie C Zimovane C Date:07/27/98ISR Number: 3109176-XReport Type:Expedited (15-DaCompany Report #GBS980701031 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS 10 MG/2 DAY 9 MON Health Norethisterone C Professional Danol C Other Date:07/27/98ISR Number: 3109179-5Report Type:Expedited (15-DaCompany Report #GBS980700986 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Fall Health Hepatic Rupture Professional Intra-Abdominal Haemorrhage Leg Amputation Polytraumatism Date:07/27/98ISR Number: 3109180-1Report Type:Expedited (15-DaCompany Report #GBS980700988 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Health Venlafaxine C Professional 24-Jun-2005 12:19 PM Page: 377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/98ISR Number: 3109183-7Report Type:Expedited (15-DaCompany Report #US_980707133 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Foreign Zyprexa PS 10MG/1 DAY 1 YR Lymphoma Health Professional Date:07/27/98ISR Number: 3109217-XReport Type:Expedited (15-DaCompany Report #DE 980700236 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Foreign Zyprexa PS Initial or Prolonged Leukopenia Health Lymphadenopathy Professional Pharyngitis Other Pyrexia Date:07/27/98ISR Number: 3109218-1Report Type:Expedited (15-DaCompany Report #DE7060583A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Activated Partial Health Cipramil C Thromboplastin Time Professional Marcumar C Prolonged Other Isoptin C Arrhythmia Atrial Fibrillation Bundle Branch Block Right Confusional State Depression Drug Interaction Gamma-Glutamyltransferase Increased Leukocytosis Lymphopenia Monocytopenia Neutrophilia Date:07/27/98ISR Number: 3109283-1Report Type:Expedited (15-DaCompany Report #EWC980400337 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine PS 15 MG/DAY Intentional Self-Injury Health Olanzapine SS 10 MG/DAY Restlessness Professional Truxal C Tavor C Date:07/27/98ISR Number: 3109284-3Report Type:Expedited (15-DaCompany Report #GBS 980700950 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Foreign Zyprexa PS 20 MG/1 DAY Pneumonia Health Enalapril C Professional Diltiazem C Isosorbide Mononitrate C Atenolol C 24-Jun-2005 12:19 PM Page: 378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Doxazosin C Aspirin C Indapamide C Date:07/27/98ISR Number: 3109605-1Report Type:Expedited (15-DaCompany Report #DE_980700178 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Zyprexa PS 15 MG DAY / Initial or Prolonged Rash Maculo-Papular Health 20 MG DAY Professional Haldol C Akineton C Date:07/27/98ISR Number: 3109803-7Report Type:Expedited (15-DaCompany Report #US_980706673 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa PS UNKNOWN 20 MG/DAY Hospitalization - Congestive Professional UNKNOWN Initial or Prolonged Chest Pain Condition Aggravated Dyspnoea Respiratory Arrest Weight Decreased Date:07/27/98ISR Number: 3109805-0Report Type:Expedited (15-DaCompany Report #US_980706658 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myeloid Metaplasia Health Zyprexa PS UNKNOWN Professional Date:07/27/98ISR Number: 3109808-6Report Type:Expedited (15-DaCompany Report #CA98025407A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa PS UNKNOWN 15 MG/1 AT Initial or Prolonged Increased Health BEDTIME Aspartate Professional UNKNOWN Aminotransferase Company Haldol (Haloperidol) C Increased Representative Ativan (Lorazepam) C Blood Alkaline Cogentin Phosphatase Increased (Benzatropine Cholelithiasis Mesilate) C Convulsion Gallbladder Disorder Gamma-Glutamyltransferase Increased Hepatitis Jaundice Sedation 24-Jun-2005 12:19 PM Page: 379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/98ISR Number: 3110116-8Report Type:Expedited (15-DaCompany Report #EWC980701067 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Spontaneous Study Zyprexa PS Health Professional Date:07/27/98ISR Number: 3110118-1Report Type:Expedited (15-DaCompany Report #EWC980701064 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zyprexa PS 7.5 MG/DAY Health Professional Other Date:07/27/98ISR Number: 3111027-4Report Type:Expedited (15-DaCompany Report #GBS980701035 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Zyprexa PS 5 MG DAY Health Chlorpromazine C Professional Paracetamol C Other Date:07/27/98ISR Number: 3111072-9Report Type:Expedited (15-DaCompany Report #GBS980400386 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Bone Marrow Depression Health Flupentixol C Drug Ineffective Professional Amoxycillin C Ecchymosis Other Leukopenia Neutropenia Thrombocytopenia Date:07/27/98ISR Number: 3111074-2Report Type:Expedited (15-DaCompany Report #GBS980400384 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Zyprexa PS 15 MG DAY Epilepsy Health Miconazole Nitrate SS Professional Date:07/27/98ISR Number: 3111076-6Report Type:Expedited (15-DaCompany Report #US98020670A Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS 10 MG/1 DAY Meningioma Professional Klonopin C Company Paxil (Paroxetine Representative Hydrochloride) C Cylert (Pemoline Magnesium) C Xanax (Alprazolam) C 24-Jun-2005 12:19 PM Page: 380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/98ISR Number: 3111079-1Report Type:Expedited (15-DaCompany Report #EWC980400332 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arthralgia Foreign Zyprexa PS 20 MG/DAY Hospitalization - Body Temperature Health Nozinan C Initial or Prolonged Decreased Professional Tegretol C Cardiac Arrest Mopral C Coma Nifluril C Disseminated Intravascular Coagulation Gastritis Hepatic Failure Hiatus Hernia Inflammation Lung Disorder Osteoarthritis Rhabdomyolysis Shock Date:07/27/98ISR Number: 3111082-1Report Type:Expedited (15-DaCompany Report #US_980504148 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS 1400 MG/DAY Initial or Prolonged Sedation Professional Paxil C Sinus Tachycardia Date:07/31/98ISR Number: 3111333-3Report Type:Expedited (15-DaCompany Report #044-0945-980059 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Neurontin PS ORAL 3200MG Health (1600MG,BID), Professional PER ORAL Zyprexa SS ORAL 100MG (, DAILY), PER ORAL Camcolit C Epilim C Dolmatil C Tertroxin C Zimovane C Date:08/04/98ISR Number: 3112827-7Report Type:Expedited (15-DaCompany Report #EWC 980500582 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercorticoidism Foreign Zyprexa PS 15 MG /DAY Initial or Prolonged Nephrotic Syndrome Health Levothyrox C Oedema Peripheral Professional Mediatensyl C Proteinuria Company Lepiticul C Representative 24-Jun-2005 12:19 PM Page: 381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3112829-0Report Type:Expedited (15-DaCompany Report #US_980402205 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa PS 5 MG/ 2 DAY Initial or Prolonged Diabetes Mellitus Professional Depakote C Other Non-Insulin-Dependent Hyperglycaemia Pulmonary Embolism Date:08/04/98ISR Number: 3112831-9Report Type:Expedited (15-DaCompany Report #US_980707059 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Zyprexa PS 5 MG/DAY 1 WK Dyspnoea Professional Cardizem (Diltiazem Tachycardia Hydrochloride) C Prinivil (Lisinopril) C Restoril (Temazepam) C Date:08/04/98ISR Number: 3112832-0Report Type:Expedited (15-DaCompany Report #GBS 980700988 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Cardiac Disorder Health Venlafaxine C Chest Pain Professional Cold Sweat Hypotension Malaise Pallor Date:08/04/98ISR Number: 3112833-2Report Type:Expedited (15-DaCompany Report #EWC980400534 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Foreign Zyprexa PS 10 MG/ DAY Haemorrhage Subcutaneous Health Clonazepam C Oedema Professional Weight Increased Date:08/04/98ISR Number: 3112835-6Report Type:Expedited (15-DaCompany Report #EWC 980500584 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS 15 MG DAY Health Artane C Professional Company Representative 24-Jun-2005 12:19 PM Page: 382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3112836-8Report Type:Expedited (15-DaCompany Report #US_ 980605558 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa PS 30 MG/DAY Drug Toxicity Professional Risperdal C Vomiting Clonazepam C Date:08/04/98ISR Number: 3112844-7Report Type:Expedited (15-DaCompany Report #DE_980700178 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Zyprexa PS 15 MG DAY / Initial or Prolonged Rash Maculo-Papular Health 20 MG DAY Professional Haldol C Akineton C Date:08/04/98ISR Number: 3113017-4Report Type:Expedited (15-DaCompany Report #EWC 980701088 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS 20 MG DAY Initial or Prolonged Health Tegretol Professional (Carbamazepine) C Other Haldol (Haloperidol) C Date:08/04/98ISR Number: 3113019-8Report Type:Expedited (15-DaCompany Report #GBS980701074 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS UNKNOWN UNK Health Procyclidine C Professional Other Date:08/04/98ISR Number: 3113267-7Report Type:Expedited (15-DaCompany Report #GBS980701061 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Abnormal Health Neglect Of Personal Professional Appearance Other Paranoia Social Avoidant Behaviour Date:08/04/98ISR Number: 3113270-7Report Type:Expedited (15-DaCompany Report #EWC980701169 Age:49 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Anuria Blood Albumin Decreased Communication Disorder Condition Aggravated Depressed Level Of Consciousness 24-Jun-2005 12:19 PM Page: 383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Haematuria Hepatic Function Abnormal Report Source Product Role Manufacturer Route Dose Duration Hypernatraemia Foreign Zyprexa PS 5 MG/DAY Hypothermia Health Trazodone C Laboratory Test Abnormal Professional Paraesthesia Rash Erythematous Sedation Thrombocytopenia Thyroid Disorder Vomiting Date:08/04/98ISR Number: 3206027-XReport Type:Periodic Company Report #US98021129A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Other Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Bradycardia Synthroid C Dizziness Dyazide C Hypertonia Atenolol C Paraesthesia Paxil C Syncope Tremor Date:08/04/98ISR Number: 3206029-3Report Type:Periodic Company Report #US97114108A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Phosphokinase Increased Professional Lithium Carbonate C Hypertension Ambien C Hypertonia Muscle Rigidity Pyrexia Tachycardia Date:08/04/98ISR Number: 3206032-3Report Type:Periodic Company Report #US97114372A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Zyprexa (Olanzapine) PS 20 MG/1 DAY 3 MON Initial or Prolonged Diabetes Mellitus Professional Lorazepam C Hyperglycaemia Date:08/04/98ISR Number: 3206036-0Report Type:Periodic Company Report #US98015059A Age:32 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Diabetes Mellitus Other Diabetic Ketoacidosis Hyperglycaemia Polyuria Sedation Stupor Tachycardia 24-Jun-2005 12:19 PM Page: 384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thirst Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Professional Depakote C Buspar C Date:08/04/98ISR Number: 3206040-2Report Type:Periodic Company Report #US98022098A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa (Olanzapine) PS 10MG/1 DAY Initial or Prolonged Polyuria Professional Navane C Thirst Company Depakote C Representative Paxil C Date:08/04/98ISR Number: 3206044-XReport Type:Periodic Company Report #US98022464A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Hyperglycaemia Professional Paxil C Toprol Xl C Date:08/04/98ISR Number: 3206046-3Report Type:Periodic Company Report #US98025323A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Diabetes Mellitus Depakote C Diabetic Ketoacidosis Lithium C Hyperglycaemia Paraesthesia Tremor Urinary Incontinence Vomiting Date:08/04/98ISR Number: 3206049-9Report Type:Periodic Company Report #US97070622A Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Professional Date:08/04/98ISR Number: 3206051-7Report Type:Periodic Company Report #US98024867A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Professional Xanax C Buspar C Nortriptyline C Propranolol C 24-Jun-2005 12:19 PM Page: 385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206054-2Report Type:Periodic Company Report #US98011948A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypoventilation Health Brevital Professional (Methohexital Sodium) PS Zyprexa (Olanzapine) SS Date:08/04/98ISR Number: 3206057-8Report Type:Periodic Company Report #US_980503212 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Literature Zyprexa (Olanzapine) PS Initial or Prolonged Neurosis Health Suicide Attempt Professional Date:08/04/98ISR Number: 3206061-XReport Type:Periodic Company Report #US_980402408 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Study Zyprexa (Olanzapine) PS 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Aspirin C Acetaminophen C Magnesium Hydroxide C Antacid Liquid Plus Simethicone C Nitroglycerin C Date:08/04/98ISR Number: 3206064-5Report Type:Periodic Company Report #US_980503152 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa (Olanzapine) PS 15 MG/QD DAY Initial or Prolonged Suicide Attempt Health Depakote (Valproate Professional Semisodium) SS 1500 MG/BID DAY Tagamet C Date:08/04/98ISR Number: 3206067-0Report Type:Periodic Company Report #US_980401403 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Health Flexeril C Professional Percocet C Date:08/04/98ISR Number: 3206069-4Report Type:Periodic Company Report #US_980504206 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 5 MG/ AT Initial or Prolonged Health BEDTIME 43 DAY Professional Oxycodone C Acetaminophen C Erythromycin C 24-Jun-2005 12:19 PM Page: 386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valaciclovir C Hydrochlorothiazide/ Triamterene C Fluoxetine C Lorazepam C Date:08/04/98ISR Number: 3206119-5Report Type:Periodic Company Report #US_980604490 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 10 MG/ AT Initial or Prolonged Health BEDTIME Professional Date:08/04/98ISR Number: 3206121-3Report Type:Periodic Company Report #US_980604555 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Psychotic Disorder Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Date:08/04/98ISR Number: 3206124-9Report Type:Periodic Company Report #US_980604759 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 5 MG /D DAY Initial or Prolonged Depression Health Depakote C Professional Loestrin C Date:08/04/98ISR Number: 3206127-4Report Type:Periodic Company Report #US_980604776 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Study Olanzapine PS 20 MG / AT Initial or Prolonged Sedation Health BEDTIME Professional Date:08/04/98ISR Number: 3206133-XReport Type:Periodic Company Report #US_980605465 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Study Olanzapine PS 2.5 MG / D Hospitalization - Renal Failure Health DAY Initial or Prolonged Urinary Tract Infection Professional Aspirin C Amlodipine C Atenolol C Date:08/04/98ISR Number: 3206135-3Report Type:Periodic Company Report #US_980605568 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Hostility Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Olanzapine PS 20 MG/D DAY Ativan C Date:08/04/98ISR Number: 3206137-7Report Type:Periodic Company Report #US_980605949 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Olanzapine PS 5 MG/BEDTIME Initial or Prolonged Health DAY Professional Haldol C Trazodone C Date:08/04/98ISR Number: 3206141-9Report Type:Periodic Company Report #US_980605998 Age:100 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Study Olanzapine PS Disability Health Professional Date:08/04/98ISR Number: 3206144-4Report Type:Periodic Company Report #US_980606080 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 10 MG/D DAY 1 WK Initial or Prolonged Hallucination Health Placebo SS 2 MG/D Paranoia Professional Olanzapine C Date:08/04/98ISR Number: 3206149-3Report Type:Periodic Company Report #US_980402436 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Study Zyprexa (Olanzapine) PS 2.5 MG / 1 Initial or Prolonged Sepsis Health DAY Professional Metamucil C Tylenol C Date:08/04/98ISR Number: 3206152-3Report Type:Periodic Company Report #US_980504164 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urinary Tract Infection Study Olanzapine PS 2.5 MG /DAY Life-Threatening Health Sinemet Cr C Hospitalization - Professional Sinemet C Initial or Prolonged Glyburide C Tylenol C Lotrisone C Dyazide C 24-Jun-2005 12:19 PM Page: 388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206155-9Report Type:Periodic Company Report #US_980604796 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Olanzapine PS 5 MG/D DAY Initial or Prolonged Urinary Tract Infection Health K-Dur C Disability Professional Cipro C Date:08/04/98ISR Number: 3206159-6Report Type:Periodic Company Report #US98023580A Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Study Zyprexa (Olanzapine) PS 2.5 MG / 1 AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Zantac C Aspirin C Vasotec C Insulin C Sinemet C Date:08/04/98ISR Number: 3206162-6Report Type:Periodic Company Report #US_980300839 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Study Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Health Multivitamin C Professional Date:08/04/98ISR Number: 3206165-1Report Type:Periodic Company Report #US97100685A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Leukocytosis Health Levothyroxine C Liver Function Test Professional Motrin C Abnormal Tylenol C Date:08/04/98ISR Number: 3206167-5Report Type:Periodic Company Report #US98011738A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Health Professional Date:08/04/98ISR Number: 3206170-5Report Type:Periodic Company Report #US_980301062 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Zyprexa (Olanzapine) PS 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Ecotrin C Multivitamin C Lasix C Kaon-Cl C Synthroid C Remeron C 24-Jun-2005 12:19 PM Page: 389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metoprolol C Ibuprofen C Apap C Keflex C Date:08/04/98ISR Number: 3206171-7Report Type:Periodic Company Report #US97103394A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Hospitalization - Dehydration Health Allegra C Initial or Prolonged Hypernatraemia Professional Synthroid C Lung Disorder Lorazepam C Pneumonia Pyrexia Date:08/04/98ISR Number: 3206174-2Report Type:Periodic Company Report #US97120121A Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Hospitalization - Pneumonia Health Zantac C Initial or Prolonged Tachycardia Professional Propulsid C Haldol C Date:08/04/98ISR Number: 3206175-4Report Type:Periodic Company Report #US_980300927 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Health Professional Date:08/04/98ISR Number: 3206185-7Report Type:Periodic Company Report #US_980503241 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Professional Company Representative Date:08/04/98ISR Number: 3206187-0Report Type:Periodic Company Report #US_980503931 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Zyprexa (Olanzapine) PS 2 YR Hospitalization - Hypertonia Professional Buspirone C Initial or Prolonged Neuroleptic Malignant Mirtazapine C Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206190-0Report Type:Periodic Company Report #US_980604521 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Depakote C Dyspnoea Ativan C Hypertonia Laboratory Test Abnormal Leukocytosis Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Sedation Stupor Thinking Abnormal Date:08/04/98ISR Number: 3206192-4Report Type:Periodic Company Report #US_980604527 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa (Olanzapine) PS 40 MG/DAY Intentional Misuse Professional Risperdal C Navane C Vasotec C Date:08/04/98ISR Number: 3206195-XReport Type:Periodic Company Report #US_980604978 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS 15 MG/DAY 1 YR Phosphokinase Increased Professional Tegretol C Coma Lisinopril C Hypertension Hytrin C Neuroleptic Malignant Atenolol C Syndrome Mysoline C Pyrexia Benadryl C Tachycardia Albuterol C Date:08/04/98ISR Number: 3206197-3Report Type:Periodic Company Report #US_980605289 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Health Zyprexa (Olanzapine) PS 7.5 MG Professional Wellbutrin C Date:08/04/98ISR Number: 3206200-0Report Type:Periodic Company Report #US_980504059 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 1 DAY Professional Trazodone C Company Risperidone C Representative 24-Jun-2005 12:19 PM Page: 391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206202-4Report Type:Periodic Company Report #US_980401270 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vomiting Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Professional Premarin C Klonopin C Buspar I Date:08/04/98ISR Number: 3206205-XReport Type:Periodic Company Report #US_980402221 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Zyprexa (Olanzapine) PS 1.25 MG/4 DAY Initial or Prolonged Gastrointestinal Disorder Professional Ritalin C Inflammatory Bowel Disease C Valium C Date:08/04/98ISR Number: 3206207-3Report Type:Periodic Company Report #US_980401894 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Diabetic Ketoacidosis Professional Trazodone C Hyperglycaemia Haldol Depot C Hypotension Ketoacidosis Thirst Vomiting Date:08/04/98ISR Number: 3206210-3Report Type:Periodic Company Report #US_980402030 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 18 MON Initial or Prolonged Diabetic Ketoacidosis Professional Hyperglycaemia Date:08/04/98ISR Number: 3206212-7Report Type:Periodic Company Report #US_980402357 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Aminotransferase Professional Depakote C Increased Blood Alkaline Phosphatase Increased Confusional State Hormone Level Abnormal Hyperglycaemia 24-Jun-2005 12:19 PM Page: 392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206214-0Report Type:Periodic Company Report #US_980402610 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS Initial or Prolonged Hyponatraemia Professional Cardizem C Colace C Lithium C Date:08/04/98ISR Number: 3206217-6Report Type:Periodic Company Report #US_980502976 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Hyponatraemia Professional Tegretol C Lamictal C Nifedipine C Prinivil C Date:08/04/98ISR Number: 3206219-XReport Type:Periodic Company Report #US_980503031 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 8 WK Initial or Prolonged Hyperglycaemia Professional Zoloft C Ketoacidosis Date:08/04/98ISR Number: 3206222-XReport Type:Periodic Company Report #US_980503935 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Hyperglycaemia Professional Respiratory Disorder Weight Increased Date:08/04/98ISR Number: 3206224-3Report Type:Periodic Company Report #US_980503937 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Hospitalization - Hyperglycaemia Professional Initial or Prolonged Date:08/04/98ISR Number: 3206226-7Report Type:Periodic Company Report #US_980606134 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 3 MON Diabetic Ketoacidosis Professional Company Representative 24-Jun-2005 12:19 PM Page: 393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206228-0Report Type:Periodic Company Report #US_980604695 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Hyperglycaemia Lithium Carbonate C Diazepam C Tegretol C Trazodone C Serzone C Paxil C Vistaril C Lopid C Date:08/04/98ISR Number: 3206230-9Report Type:Periodic Company Report #US_980604754 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Face Oedema Tegretol C Oedema Peripheral Depakote C Pyrexia Nimotop C Sedation Synthroid C Oscal C Tylenol C Ferrous Sulfate C Lo C Neutra-Phos C Date:08/04/98ISR Number: 3206386-8Report Type:Periodic Company Report #US_980401276 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Neuroleptic Malignant Professional Buspar (Buspirone Other Syndrome Company Hydrochloride) C Representative Remeron (Mirtazapine) C Date:08/04/98ISR Number: 3206387-XReport Type:Periodic Company Report #US_980402211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 20 MG/ 1DAY Initial or Prolonged Professional Sinequan (Doxepin Hydrochloride) C Date:08/04/98ISR Number: 3206388-1Report Type:Periodic Company Report #US_980503782 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Consumer Zyprexa (Olanzapine) PS 10 MG/DAY 1 YR Initial or Prolonged Personality Disorder Company Representative 24-Jun-2005 12:19 PM Page: 394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206390-XReport Type:Periodic Company Report #US_980503791 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Personality Disorder Company Representative Date:08/04/98ISR Number: 3206392-3Report Type:Periodic Company Report #US_980604233 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa (Olanzapine) PS Initial or Prolonged Hypertonia Professional Tegretol Intentional Misuse (Carbamazepine) C Carbutamide C Lovastatin C Lorazepam C Date:08/04/98ISR Number: 3206393-5Report Type:Periodic Company Report #US_980604465 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Hallucination Professional Intentional Misuse Date:08/04/98ISR Number: 3206396-0Report Type:Periodic Company Report #US_980604707 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Hostility Professional Perphenazine C Company Representative Date:08/04/98ISR Number: 3206399-6Report Type:Periodic Company Report #US_980606028 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Lithium C Diazepam C Synthroid (Levothyroxine Sodium) C Date:08/04/98ISR Number: 3206402-3Report Type:Periodic Company Report #US_980606165 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Haloperidol C Company Haldol (Haloperidol) C Representative 24-Jun-2005 12:19 PM Page: 395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206405-9Report Type:Periodic Company Report #US_980606174 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Zyprexa (Olanzapine) PS 15 MG/1 DAY 8 WK Cardiovascular Disorder Professional Sinemet Cr C Drug Ineffective Tasmar (Tolcapone)C C Dystonia Proamatine Hyperreflexia (Midodrine Hypertonia Hydrochloride) C Movement Disorder Neuroleptic Malignant Syndrome Personality Disorder Pyrexia Stupor Tardive Dyskinesia Date:08/04/98ISR Number: 3206408-4Report Type:Periodic Company Report #US_980402334 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Consumer Zyprexa (Olanzapine) PS 5 MG/DAY 2 MON Initial or Prolonged Lithium C Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Bumex (Bumetanide) C Potassium C Prednisone C Date:08/04/98ISR Number: 3206410-2Report Type:Periodic Company Report #US_980503181 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Consumer Zyprexa (Olanzapine) PS 5 MG/1DAY Haloperidol C Lithium Carbonate C Lorazepam C Benztropine C Senna C Divalproex Sodium C Acetaminophen C Date:08/04/98ISR Number: 3206412-6Report Type:Periodic Company Report #US_980604858 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa (Olanzapine) PS 10 MG/ AT Initial or Prolonged Apathy BEDTIME Epistaxis Phenylpropanolamine Hallucination W/ Guaifenesin C Hostility Tessalon Perle Influenza Like Illness (Benzonatate) C Personality Disorder Septra Ds C Weight Increased 24-Jun-2005 12:19 PM Page: 396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206413-8Report Type:Periodic Company Report #US_980606081 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Intentional Misuse Prozac (Fluoxetine Hydrochloride) SS 1 WK Risperdal (Risperidone) C Date:08/04/98ISR Number: 3206416-3Report Type:Periodic Company Report #US97123277A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Health Zyprexa (Olanzapine) PS 15 MG/ 1 DAY Hospitalization - Blood Creatine Professional Inderal La Initial or Prolonged Phosphokinase Increased (Propranolol Delirium Hydrochloride) C Extrapyramidal Disorder Amantadine C Gait Disturbance Cardura (Doxazosin Hypertonia Mesilate) C Liver Function Test Cogentin Abnormal (Benzatropine Neuroleptic Malignant Mesilate) C Syndrome Antacid (Titralac) C Pyrexia Tylenol Sedation (Paracetamol) C Tremor Multivitamin (Multivitamins) C Ativan (Lorazepam) C Perphenazine C Lithium C Tegretol (Carbamazepine) C Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Date:08/04/98ISR Number: 3206418-7Report Type:Periodic Company Report #US97123682A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS 3 DAY Phosphokinase Increased Professional Wellbutrin Delirium (Amfebutamone Leukocytosis Hydrochloride) C Neuroleptic Malignant Trazodone C Syndrome Date:08/04/98ISR Number: 3206420-5Report Type:Periodic Company Report #US98013745A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa (Olanzapine) PS 300 MG / DAY Initial or Prolonged Sedation Professional Trazodone C 24-Jun-2005 12:19 PM Page: 397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206423-0Report Type:Periodic Company Report #US98023238A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa (Olanzapine) PS Initial or Prolonged Intentional Misuse Professional Stupor Date:08/04/98ISR Number: 3206433-3Report Type:Periodic Company Report #US98024669A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa (Olanzapine) PS Syndrome Professional Company Representative Date:08/04/98ISR Number: 3206435-7Report Type:Periodic Company Report #US_980300658 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Olanzapine PS 10 MG/DAY Phosphokinase Increased Professional Valproic Acid C Dyskinesia Other Lorazepam C Hyperhidrosis Vitamins C Hypertonia Neuroleptic Malignant Syndrome Pyrexia Stupor Tachycardia Urinary Incontinence Date:08/04/98ISR Number: 3206813-6Report Type:Periodic Company Report #US_980605665 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Olanzapine PS 7.5 MG/D DAY Initial or Prolonged Health Lasix C Professional Vasotec C Toprol Xl C Potassium Chloride C Synthroid C Multivitamin C Lactulose C Acetylsalicylic Acid C Lortab C Date:08/04/98ISR Number: 3206814-8Report Type:Periodic Company Report #US_980401419 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa (Olanzapine) PS 2.5 MG/ 1DAY Health Synthroid C Professional Multivitamins C Senokot C Axid C Artificial Tears C 24-Jun-2005 12:19 PM Page: 398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ferrous Sulfate C Date:08/04/98ISR Number: 3206815-XReport Type:Periodic Company Report #US_980503082 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Olanzapine PS 20 MG/QD DAY Life-Threatening Health Lopid C Professional Niaspan C Ambien C Prozac C Lotensin C Amaryl C Atenolol C Date:08/04/98ISR Number: 3206816-1Report Type:Periodic Company Report #US_980503436 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 2.5 MG/QHS Initial or Prolonged Hypotension Health DAY Sedation Professional Allopurinol C Insulin Humulin C Glyburide C Clonidine C Fosinopril C Lasix C Albuterol C Beclomethasone Dipropionate C Motrin C Co-Trimoxazole C Date:08/04/98ISR Number: 3206817-3Report Type:Periodic Company Report #US_980604286 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Study Olanzapine PS 5 MG Arrhythmia Health Hypoventilation Professional Sinus Bradycardia Syncope Date:08/04/98ISR Number: 3206819-7Report Type:Periodic Company Report #US_980604821 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Ischaemia Study Olanzapine PS 5 MG/D DAY Initial or Prolonged Health Aspirin C Disability Professional Lanoxin C 24-Jun-2005 12:19 PM Page: 399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206822-7Report Type:Periodic Company Report #US_980605171 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Olanzapine PS 10 MG/D DAY Health Professional Date:08/04/98ISR Number: 3206825-2Report Type:Periodic Company Report #US_980402270 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Study Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Haemorrhage Health Ultram C Professional Desyrel C Paxil C Buspar C Tylenol C Lasix C Coumadin C Ismo C Miacalcin C Theragran C Thiamine C Tums C Micro K Extencaps C Date:08/04/98ISR Number: 3206826-4Report Type:Periodic Company Report #US_980503401 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS Initial or Prolonged Health Combivir C Professional Viracept C Date:08/04/98ISR Number: 3206829-XReport Type:Periodic Company Report #US_980504163 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Professional Date:08/04/98ISR Number: 3206831-8Report Type:Periodic Company Report #US_980504178 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Study Olanzapine PS 10 MG/AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Deponit C Ferrous Sulfate C Glyburide C Carbamazepine C Trazodone C Zoloft C 24-Jun-2005 12:19 PM Page: 400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206833-1Report Type:Periodic Company Report #US_980605854 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Study Olanzapine PS 5 MG/DAY Phosphokinase Increased Health Vitamin E C Professional Aquaphor C Camphor, Menthol, Phenol, Emollient Lotion C Aloe Vesta Protective C Ascorbid Acid C Zinc Sulfate C Date:08/04/98ISR Number: 3206836-7Report Type:Periodic Company Report #US_980401803 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa (Olanzapine) PS 5 MG/ 2 DAY Initial or Prolonged Health Professional Date:08/04/98ISR Number: 3206838-0Report Type:Periodic Company Report #US_980503163 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Hallucination Health Professional Date:08/04/98ISR Number: 3206841-0Report Type:Periodic Company Report #US_980503406 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Study Olanzapine PS Initial or Prolonged Health Professional Date:08/04/98ISR Number: 3206843-4Report Type:Periodic Company Report #US_980503464 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa (Olanzapine) PS 2.5 MG/QHS Initial or Prolonged Hostility Health DAY Professional Timoptic-Xe C Trinsicon C Xalatan C Ativan C Restoril C Maalox C Hydrocortisone C Tylenol C 24-Jun-2005 12:19 PM Page: 401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3206846-XReport Type:Periodic Company Report #US_980503657 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 20 MG/DAY Olanzapine SS 15 MG/ AT BEDTIME Motrin C Date:08/04/98ISR Number: 3206848-3Report Type:Periodic Company Report #US_980503761 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 10 MG/AT Initial or Prolonged Health BEDTIME Professional Date:08/04/98ISR Number: 3206851-3Report Type:Periodic Company Report #US_980503889 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Olanzapine PS 5 MG Initial or Prolonged Health Nadolol C Professional Date:08/04/98ISR Number: 3206854-9Report Type:Periodic Company Report #US_980504135 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Prozac SS 20 MG/DAY Professional Depakote C Ativan C Guaifenesin C Sudafed C Bc Powder C Genora C Vicks Formula 44 C Testosterone Propionate C Date:08/05/98ISR Number: 3113716-4Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ketoacidosis Depakote PS 1500 QHS Pancreatitis Haemorrhagic Zyprexa SS 5 QHS Pancreatitis Necrotising Eskalith C Ativan C 24-Jun-2005 12:19 PM Page: 402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/98ISR Number: 3114599-9Report Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa PS Eli Lilly ORAL 5 MG PO Q AM Initial or Prolonged Phosphokinase Increased Zocor C Prinivil C Lovazepam C Diabeta C K-Dur C Asa C Lasix C Synthroid C Prolixin C Artane C Date:08/10/98ISR Number: 3114645-2Report Type:Direct Company Report # Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Health Zyprexa PS Lilly ORAL 5 MG PO HS Sedation Professional Setraline C Feso4 C Clonazepam C Date:08/10/98ISR Number: 3114649-XReport Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Lilly ORAL 10MG HS ORAL Professional Zyprexa SS Lilly ORAL 5MG HS ORAL Cimetidine C Diazepam C Lico3 C Temazepam C Date:08/10/98ISR Number: 3114890-6Report Type:Expedited (15-DaCompany Report #EWC980701205 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa PS 7.5 MG/DAY Hypercapnia Health Fluvoxamine C Hypoxia Professional Respiratory Failure Sedation Tachypnoea Date:08/10/98ISR Number: 3114892-XReport Type:Expedited (15-DaCompany Report #EWC980701154 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa PS 15 MG/DAY Intraventricular Health Zyprexa SS 10 MG/DAY Haemorrhage Professional Vascular Anomaly 24-Jun-2005 12:19 PM Page: 403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/98ISR Number: 3114897-9Report Type:Expedited (15-DaCompany Report #US_980707654 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antepartum Haemorrhage Health Zyprexa PS 10 MG/DAY Professional Prozac SS 20 MG/DAY Klonopin (Clonazapam) C Date:08/10/98ISR Number: 3114901-8Report Type:Expedited (15-DaCompany Report #US_980707769 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Health Zyprexa PS 20 MG /DAY Other Drug Abuser Professional Cocaine C Eye Haemorrhage Company Cogentin Maculopathy Representative (Benzatropine Vision Blurred Mesilate) C Wellbutrin Sr (Amfebutamone Hydrochloride) C Date:08/10/98ISR Number: 3114904-3Report Type:Expedited (15-DaCompany Report #DE_980700181 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Health Professional Date:08/10/98ISR Number: 3114908-0Report Type:Expedited (15-DaCompany Report #US_980707621 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Olanzapine PS NI Congenital Anomaly Exposure To Therapeutic Health Drugs Professional Congenital Anomaly Stillbirth Date:08/10/98ISR Number: 3114912-2Report Type:Expedited (15-DaCompany Report #US-980707654 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antepartum Haemorrhage Health Zyprexa PS 10 MG/DAY Professional Prozac SS 20 MG/DAY A FEW YEARS Klonopin C Date:08/10/98ISR Number: 3114914-6Report Type:Expedited (15-DaCompany Report #US_980707492 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS UNK Professional 24-Jun-2005 12:19 PM Page: 404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/98ISR Number: 3114917-1Report Type:Expedited (15-DaCompany Report #US-980707694 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Auricular Swelling Health Zyprexa PS UNK Initial or Prolonged Blood Pressure Increased Professional Bupropion C Blood Thyroid Stimulating Other Dextroamphetamine Hormone Decreased Sulfate C Drug Interaction Hyperglycaemia Hypersensitivity Leukocytosis Rash Maculo-Papular Rash Pruritic Skin Ulcer Tachycardia Date:08/10/98ISR Number: 3114953-5Report Type:Expedited (15-DaCompany Report #GBS980801166 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa PS UNK Increased Health Blood Thyroid Stimulating Professional Hormone Increased Other Hypothyroidism Lethargy Sedation Weight Increased Date:08/10/98ISR Number: 3114954-7Report Type:Expedited (15-DaCompany Report #US_980707483 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS 10 MG/DAY 10 MON Professional Prolixin Decanoate (Fluphenazine Decanoate) C Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Artane (Trihexyphendidyl Hydrochloride) C Date:08/11/98ISR Number: 3114546-XReport Type:Direct Company Report # Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Zyprexia PS Hospitalization - Faecal Incontinence Oops C Initial or Prolonged Feeling Abnormal Salivary Hypersecretion Sedation Trismus 24-Jun-2005 12:19 PM Page: 405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/98ISR Number: 3115457-6Report Type:Expedited (15-DaCompany Report #US_980606105 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Zyprexa PS 5 MG/DAY Professional Lamivudine C Acyclovir C Stavudine C Date:08/11/98ISR Number: 3115460-6Report Type:Expedited (15-DaCompany Report #EWC980400342 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastrointestinal Disorder Foreign Zyprexa PS 20 MG DAY Hospitalization - Suicide Attempt Health Truxal C Initial or Prolonged Professional Haldol C Date:08/11/98ISR Number: 3115462-XReport Type:Expedited (15-DaCompany Report #GBS980700955 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Analgesic Drug Level Foreign Zyprexa PS 10 MG/1DAY Life-Threatening Above Therapeutic Health Paracetamol C Hospitalization - Antidepressant Drug Level Professional Ferrous Sulphate C Initial or Prolonged Below Therapeutic Brain Hypoxia Brain Oedema Cardio-Respiratory Arrest Circulatory Collapse Convulsion Electrocardiogram Qt Prolonged Headache Hepatic Function Abnormal Pneumonia Prothrombin Level Decreased Pupil Fixed Pyrexia Date:08/12/98ISR Number: 3117273-8Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Zyprexa PS Lilly And Co ORAL 5 MG PO Q HS 3 MON Eosinophilia Fatigue Date:08/14/98ISR Number: 3117009-0Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Zyprexa PS ORAL 30MG QD PO Required Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/98ISR Number: 3117776-6Report Type:Expedited (15-DaCompany Report #US_980503349 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Zyprexa PS 10 MG/DAY Hospitalization - Cerebrovascular Accident Professional Initial or Prolonged Hepatic Function Abnormal Company Renal Failure Acute Representative Date:08/17/98ISR Number: 3117784-5Report Type:Expedited (15-DaCompany Report #CA_980800099 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa PS 12.5 MG/1 DAY Initial or Prolonged Blood Creatine Health Clonazepam C Other Phosphokinase Increased Professional Benztropine Mesylate C Communication Disorder Lorazepam C Dyskinesia Leukocytosis Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:08/17/98ISR Number: 3117786-9Report Type:Expedited (15-DaCompany Report #US_980808185 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS 30 MG/DAY Initial or Prolonged Drug Ineffective Professional Mood Swings Paranoia Date:08/17/98ISR Number: 3117787-0Report Type:Expedited (15-DaCompany Report #EWC 980801234 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Rupture Foreign Zyprexa PS 10 MG/DAY Cardiac Arrest Health Tegretol C Malaise Professional Imovane C Date:08/17/98ISR Number: 3117788-2Report Type:Expedited (15-DaCompany Report #GBS98080801175 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Foreign Zyprexa PS Date:08/17/98ISR Number: 3117790-0Report Type:Expedited (15-DaCompany Report #US_980808019 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/98ISR Number: 3117791-2Report Type:Expedited (15-DaCompany Report #GBS 980801177 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa PS 210 MG Initial or Prolonged Electroencephalogram Health Abnormal Professional Intentional Misuse Other Date:08/17/98ISR Number: 3117793-6Report Type:Expedited (15-DaCompany Report #US_980808047 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Zyprexa PS 10 MG/DAY Myocardial Infarction Professional Clozaril (Clozapine) C Weight Increased Buspar (Buspirone Hydrochloride) C Date:08/17/98ISR Number: 3117794-8Report Type:Expedited (15-DaCompany Report #EWC 980801270 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prothrombin Time Foreign Zyprexa PS Initial or Prolonged Shortened Health Citalopram C Professional Remid C Other Chloraldurate C Digimerck C Marcumar C Adumbran C Date:08/17/98ISR Number: 3117795-XReport Type:Expedited (15-DaCompany Report #EWC 980801257 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyporeflexia Foreign Zyprexa PS 15 MG/DAY; 10 Initial or Prolonged Paresis Health MG DAY Polyneuropathy Professional Propranolol C Thyroid Medication C Date:08/17/98ISR Number: 3117796-1Report Type:Expedited (15-DaCompany Report #US_980807853 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS 5 MG/DAY Initial or Prolonged Psychotic Disorder Professional Prolixin C Norvasc C Ativan C Date:08/17/98ISR Number: 3117800-0Report Type:Expedited (15-DaCompany Report #US_980808312 Age:18 YR Gender:Male I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Dehydration Diarrhoea Dysarthria Eye Movement Disorder 24-Jun-2005 12:19 PM Page: 408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Haemoglobinuria Liver Function Test Report Source Product Role Manufacturer Route Dose Duration Abnormal Health Zyprexa PS 10 MG/1 DAY Muscular Weakness Professional Depakote C Mydriasis Pyrexia Rhabdomyolysis Date:08/17/98ISR Number: 3117856-5Report Type:Expedited (15-DaCompany Report #US_980808115 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS 30 MG/DAY Professional Date:08/17/98ISR Number: 3117880-2Report Type:Expedited (15-DaCompany Report #US_980707694 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Auricular Swelling Health Zyprexa PS Initial or Prolonged Blood Pressure Increased Professional Bupropion C Blood Thyroid Stimulating Other Dextroamphetamine Hormone Decreased Sulfate C Drug Hypersensitivity Hyperglycaemia Leukocytosis Pruritus Rash Maculo-Papular Skin Ulcer Tachycardia Date:08/18/98ISR Number: 3117854-1Report Type:Expedited (15-DaCompany Report #DE_980800277 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyrpexa PS 7.5 MG DAY Initial or Prolonged Health Decortin Professional (Prednisone) C Other Tofranil (Imipramine Hydrochloride) C L-Thyroxin (Levothyroxine Sodium) C Date:08/18/98ISR Number: 3117881-4Report Type:Expedited (15-DaCompany Report #GBS980701031 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS 10 MG/2 DAY Health Microynn C Professional 24-Jun-2005 12:19 PM Page: 409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/98ISR Number: 3119578-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Sandoz ORAL 12.5 MG PO QD Phosphokinase Increased Zyprexa SS Lilly ORAL 30MG PO QD (DIVIDED) Date:08/19/98ISR Number: 3119049-4Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:08/19/98ISR Number: 3119091-3Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Olanzapine PS ORAL 5 MG/QHS/PO Intervention to Abnormal Trihexyphenidyl C Prevent Permanent Multivitamins Rowell C Impairment/Damage Docusate Sodium C Lactulose C Date:08/19/98ISR Number: 3122617-7Report Type:Expedited (15-DaCompany Report #EWC980801257 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyporeflexia Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Paresis Health Propranolol C Polyneuropathy Professional Thyroid Medication C Other Date:08/25/98ISR Number: 3122153-8Report Type:Expedited (15-DaCompany Report #DE97032923A Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Neutropenia Health Melperone C Professional Date:08/25/98ISR Number: 3122175-7Report Type:Expedited (15-DaCompany Report #US_980706299 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa PS 10 MG/1 DAY Initial or Prolonged Fatigue Health Lethargy Professional Libido Decreased Medication Error Psychomotor Retardation Weight Increased 24-Jun-2005 12:19 PM Page: 410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/98ISR Number: 3122621-9Report Type:Expedited (15-DaCompany Report #US_980605686 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS 10 MG/DAY Initial or Prolonged Haemorrhage Professional Lodine C Other Idiopathic Buspar C Thrombocytopenic Purpura Thrombocytopenia Date:08/25/98ISR Number: 3122624-4Report Type:Expedited (15-DaCompany Report #US_980401676 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS 10 MG/IN THE Initial or Prolonged Cardiac Failure Professional EVENING Other Congestive Prozac (Fluoxetine Cardiomegaly Hydrochloride) SS 20 MG Coma Lithium C Confusional State Monopril C Delirium Precose C Disorientation Synthroid C Dyspnoea Accolate C Fatigue Aspirin C Hallucination Axid C Oedema Florinef C Renal Failure Glucophage C Sedation Therapeutic Agent Toxicity Thought Blocking Weight Increased Date:08/25/98ISR Number: 3122627-XReport Type:Expedited (15-DaCompany Report #GBS980700955 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Foreign Zyprexa PS 10 MG/1 DAY Life-Threatening Brain Oedema Health Paracetamol C Hospitalization - Cardiac Failure Professional Ferrous Sulphate C Initial or Prolonged Cardio-Respiratory Arrest Other Trifluoperazine C Circulatory Collapse Procyclidine C Convulsion Stemetil C Drug Level Above Therapeutic Drug Level Below Therapeutic Electrocardiogram Qt Prolonged Headache Hepatic Function Abnormal Neurological Examination Abnormal Overdose Pneumonia Pulse Absent Pupil Fixed Pyrexia Renal Failure 24-Jun-2005 12:19 PM Page: 411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/98ISR Number: 3122713-4Report Type:Expedited (15-DaCompany Report #AU_980800158 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS UNKNOWN 5 MG 1 AT Initial or Prolonged Health BEDTIME Professional UNKNOWN Date:08/25/98ISR Number: 3122714-6Report Type:Expedited (15-DaCompany Report #DE_980800322 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa PS UNKNOWN 10 MG DAY Initial or Prolonged Health UNKNOWN AND Professional 15 MG DAY UNKNOWN Date:08/26/98ISR Number: 3121980-0Report Type:Expedited (15-DaCompany Report #CA_980800106 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Foreign Zyprexa PS 10 MG/1 DAY Initial or Prolonged Health Epival C Professional Date:08/26/98ISR Number: 3121983-6Report Type:Expedited (15-DaCompany Report #EWC980801293 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS 280 MG/DAY Initial or Prolonged Akathisia Health Depressed Level Of Professional Consciousness Company Depression Representative Intentional Misuse Muscle Rigidity Suicide Attempt Visual Acuity Reduced Date:08/26/98ISR Number: 3121986-1Report Type:Expedited (15-DaCompany Report #EWC980801290 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Foreign Zyprexa PS 20 MG/DAY Initial or Prolonged Loss Of Consciousness Health Nozinan C Nervous System Disorder Professional Paresis Date:08/26/98ISR Number: 3121990-3Report Type:Expedited (15-DaCompany Report #US_980706345 Age:70 YR Gender:Male I/FU:I Outcome PT Death Abdominal Pain Hospitalization - Ascites Initial or Prolonged Confusional State Delirium Electrolyte Imbalance 24-Jun-2005 12:19 PM Page: 412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Grand Mal Convulsion Hyponatraemia Lethargy Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Zyprexa PS 5 MG/DAY Oedema Professional Oncovin SS Pancytopenia Neupogen C Pleural Effusion Restoril C Pneumonia Vicodin C Pyrexia Atarax C Sepsis Insulin C Cyclophosphamide C Doxorubicin C Prenisone C Date:08/26/98ISR Number: 3121993-9Report Type:Expedited (15-DaCompany Report #US_980808450 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Acute Health Zyprexa PS 20 MG/DAY Professional Risperdal C Vasotec C Depakote C Klonopin C Date:08/27/98ISR Number: 3123059-0Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Zyprexa PS ORAL ONCE PO Hospitalization - Circulatory Collapse Haldol C Initial or Prolonged Coma Ativan C Cyanosis Depakote C Heart Rate Decreased Hypotension Pain In Extremity Date:08/31/98ISR Number: 3124042-1Report Type:Expedited (15-DaCompany Report #GBS 980801318 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS UNKNOWN UNK Date:08/31/98ISR Number: 3124043-3Report Type:Expedited (15-DaCompany Report #GBS980801326 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Foreign Zyprexa PS UNKNOWN 15 MG/1 DAY Initial or Prolonged Systemic Lupus Health Paroxetine C Erythematosus Professional Phenytoin C Other Lithium C Benperidol C Diazepam C Atenolol C Temazepam C Carbamazepine C Calcipotriol C Beclomethasone 24-Jun-2005 12:19 PM Page: 413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diproprionate C Ipratropium C Chlorpromazine C Flupentixol C Date:08/31/98ISR Number: 3124044-5Report Type:Expedited (15-DaCompany Report #US_980808923 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS UNKNOWN 10 MG/1 DAY Initial or Prolonged Condition Aggravated Professional Psychotic Disorder Company Pyromania Representative Date:08/31/98ISR Number: 3124045-7Report Type:Expedited (15-DaCompany Report #DE_980700205 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Zyprexa PS UNKNOWN 10 MG DAY Initial or Prolonged Hepatitis Health Hepatomegaly Professional Jaundice Liver Function Test Abnormal Pruritus Date:08/31/98ISR Number: 3124046-9Report Type:Expedited (15-DaCompany Report #DE_980800331 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Zyprexa PS UNKNOWN 10 MG DAY Hospitalization - Cyanosis Health Serdolect SS UNKNOWN 20 MG DAY Initial or Prolonged Drug Effect Decreased Professional Melleril Dyspnoea (Thioridazine Hydrochloride) C Oral Contraceptive Nos C Date:08/31/98ISR Number: 3124047-0Report Type:Expedited (15-DaCompany Report #DE_980800347 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zyprexa PS UNKNOWN 10 MG DAY Initial or Prolonged Loss Of Consciousness Health Tavor (Lorazepam) C Tongue Disorder Professional Noctamid Urinary Incontinence Other (Lormetazepam) C Date:08/31/98ISR Number: 3124182-7Report Type:Expedited (15-DaCompany Report #EWC980701154 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa PS 15 MG/DAY - Intraventricular Health 10 MG DAY Haemorrhage Professional 24-Jun-2005 12:19 PM Page: 414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/98ISR Number: 3124184-0Report Type:Expedited (15-DaCompany Report #EWC980600956 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS 10 MG/DAY Health Urbanyl C Professional Rohypnol C Company Modecate C Representative Date:08/31/98ISR Number: 3124185-2Report Type:Expedited (15-DaCompany Report #EWC980300101 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zyprexa PS 20 MG/DAY Initial or Prolonged Health Tavor C Professional Isoket Retard C Saroten C Date:08/31/98ISR Number: 3124187-6Report Type:Expedited (15-DaCompany Report #US_980605970 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pre-Existing Condition Health Zyprexa PS Improved Professional Renal Impairment Date:08/31/98ISR Number: 3124188-8Report Type:Expedited (15-DaCompany Report #GBS980701074 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Health Procyclidine C Professional Date:08/31/98ISR Number: 3124189-XReport Type:Expedited (15-DaCompany Report #US_980808450 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Acute Health Zyprexa PS 20 MG/DAY Professional Risperdal C Vasotec C Klonopin C Date:08/31/98ISR Number: 3124190-6Report Type:Expedited (15-DaCompany Report #US_980808115 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zyprexa PS 30 MG/DAY Overdose Professional Lithium C 24-Jun-2005 12:19 PM Page: 415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/98ISR Number: 3124268-7Report Type:Expedited (15-DaCompany Report #US98024165A Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Consumer Zyprexa PS 5 MG/1 DAY Influenza Like Illness Health Depakote C Ketoacidosis Professional Eskalith C Pancreatitis Haemorrhagic Other Pyrexia Date:08/31/98ISR Number: 3124271-7Report Type:Expedited (15-DaCompany Report #GB98022263A Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Septal Defect Foreign Zyprexa PS 20 MG AT Blood Creatine Health BEDTIME Phosphokinase Increased Professional Lofepramine C Cardiac Failure Company Trifluoperazine C Cardio-Respiratory Arrest Representative Dothiepin C Catatonia Other Diazepam C Hepatic Steatosis Zopiclone C Hypotension Hypotonia Muscle Rigidity Myocardial Infarction Myocarditis Neuroleptic Malignant Syndrome Pyrexia Tachypnoea Date:08/31/98ISR Number: 3124688-0Report Type:Expedited (15-DaCompany Report #DE_980800322 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Foreign Zyprexa PS 10 MG DAY Health Zyprexa SS 15 MG DAY Professional Other Date:08/31/98ISR Number: 3124689-2Report Type:Expedited (15-DaCompany Report #US98023373A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS 660 MG Initial or Prolonged Overdose Professional Other Company Representative Date:09/01/98ISR Number: 3124438-8Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Required Diabetes Mellitus Intervention to Insulin-Dependent Prevent Permanent Diabetic Ketoacidosis Impairment/Damage Lethargy Sedation 24-Jun-2005 12:19 PM Page: 416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Tongue Disorder Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS Lilly 30MG/ DAILY Date:09/02/98ISR Number: 3125908-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Olanzapine PS Lilly ORAL 10 MG Q AM PO Initial or Prolonged Confusional State Professional Lithium Carbonate Depressed Level Of (600 Mg, Roxane) SS Roxane ORAL 600 MG BID PO Consciousness Lorazepam C Disorientation Disturbance In Attention Dyskinesia Dystonia Leukocytosis Masked Facies Muscle Rigidity Neuroleptic Malignant Syndrome Psychotic Disorder Pyrexia Tachycardia Date:09/02/98ISR Number: 3126350-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Isordil PS 20 MG PO TID Intervention to Fall Zyprexa SS 2.5 MG BID Prevent Permanent Hypotension Asa C Impairment/Damage Colace C Prozac C Multivit. C Prilosec C Dulcolax C Date:09/02/98ISR Number: 3126354-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Zyprexa PS ORAL 20 MG PO HIS Intervention to Klonopin C Prevent Permanent Haldol C Impairment/Damage Benadryl C Vasotec C Procardia Xl C Dyazide C Date:09/02/98ISR Number: 3126365-9Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Blood Creatine Zyprexa PS 10 MG QD Phosphokinase Increased Amitriptyline C Body Temperature Nardil C Increased Inderal C Coma Verapamil C Mental Impairment Ultram C Neuroleptic Malignant Syndrome Renal Impairment Date:09/02/98ISR Number: 3126765-7Report Type:Expedited (15-DaCompany Report #GBS980801366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Fibrosis Foreign Zyprexa PS 10 MG/ 1 DAY Liver Function Test Health Abnormal Professional Date:09/03/98ISR Number: 3125547-XReport Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Olanzapine PS UNKNOWN 2.5 MG Q DAY Initial or Prolonged Balance Disorder Methylphenidate C Required Blood Pressure Increased Oxybutynin C Intervention to Condition Aggravated Sertrazine C Prevent Permanent Dizziness Naprosyn C Impairment/Damage Fall Lethargy Mental Impairment Neuroleptic Malignant Syndrome Psychiatric Symptom Speech Disorder White Blood Cells Urine Positive Date:09/03/98ISR Number: 3125614-0Report Type:Expedited (15-DaCompany Report #S98-DEN-00467-01 (-1) Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prothrombin Level Foreign Citalopram PS ORAL 20 MG QD PO Initial or Prolonged Decreased Health Zyprexa SS Professional Remid (Allopurinol) C Chloraldurat (Chloral Hydrate) C Digimerck (Digitoxin) C Marcumar (Phenprocoumon) C Isoptin (Verapamil Hydrochlordie) C Adumbran (Oxazepam) C 24-Jun-2005 12:19 PM Page: 418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/98ISR Number: 3125665-6Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Zyprexa PS Initial or Prolonged Congestive Depakote SS 500G BID Oedema Peripheral Paxil C Coumadin C Date:09/03/98ISR Number: 3125671-1Report Type:Direct Company Report # Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Zyprexa PS 5MG QHS Abnormal Depakote SS 2500MG QD Electrocardiogram T Wave Ibuprofen C Inversion Fluoxetine C Date:09/03/98ISR Number: 3125672-3Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Zyprexa PS 7.5MG QHS Abnormal Depakote SS 2500MG QD Electrocardiogram T Wave Isoniazid C Inversion Anafranil C Hyperhidrosis Pyridoxine C Skin Discolouration Ibuprofen C Sluggishness Date:09/03/98ISR Number: 3125693-0Report Type:Direct Company Report # Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Choking Zyprexa PS ORAL 1/2 TAB PO Intervention to Faecal Incontinence BID X7 D Prevent Permanent Feeling Cold Zoloft C Impairment/Damage Pyrexia Zantac C Thirst Tremor Urinary Incontinence Date:09/03/98ISR Number: 3125814-XReport Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Increased Olanzapine PS ORAL 5 MG PO TID Convulsion QD Hypotension Prozac C Muscle Rigidity Pupil Fixed Pyrexia Tachycardia 24-Jun-2005 12:19 PM Page: 419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/98ISR Number: 3126514-2Report Type:Expedited (15-DaCompany Report #M086235 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Serzone PS ORAL 100 MG BID Initial or Prolonged Dysarthria Professional ORAL Sedation Zyprexa SS ORAL 10 MG OHS ORAL Date:09/08/98ISR Number: 3126745-1Report Type:Expedited (15-DaCompany Report #US97084501A Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Literature Zyprexa PS 5 MG 1 DAY 1 DAY Initial or Prolonged Hypotension Health Cardura C Priapism Professional Gabapentin C Urinary Retention Lansoprazole C Temazepam C Triazolam C Perphenazine C Lorazepam C Acetaminophen C Antacid C Milk Of Magnesia C Furosemide C Benazepril C Date:09/08/98ISR Number: 3126748-7Report Type:Expedited (15-DaCompany Report #US_980909404 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Zyprexa PS 5 MG DAY Initial or Prolonged Dysarthria Professional Depakote C Date:09/08/98ISR Number: 3126751-7Report Type:Expedited (15-DaCompany Report #US_980809379 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Consumer Zyprexa PS 5 MG 1 DAY Initial or Prolonged Health Atenolol C Professional Company Representative Date:09/08/98ISR Number: 3126761-XReport Type:Expedited (15-DaCompany Report #DE_980800374 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Health Ibuprofen C Professional Akineton Retard C Diazepam C 24-Jun-2005 12:19 PM Page: 420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/98ISR Number: 3126769-4Report Type:Expedited (15-DaCompany Report #DE_980800372 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Zyprexa PS 20 MG DAY / Initial or Prolonged Abnormal Health 10 MG DAY Thrombocytopenia Professional Biperiden C Fluphenazine C Date:09/08/98ISR Number: 3126776-1Report Type:Expedited (15-DaCompany Report #CA_980800122 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa PS Hospitalization - Syndrome Health Haldol C Initial or Prolonged Pyrexia Professional Other Date:09/08/98ISR Number: 3126777-3Report Type:Expedited (15-DaCompany Report #AU_980800177 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa PS 20 MG/ 1 DAY Initial or Prolonged Hyponatraemia Health Antibiotic C Inappropriate Professional Antidiuretic Hormone Secretion Malaise Date:09/08/98ISR Number: 3126778-5Report Type:Expedited (15-DaCompany Report #AU_980800182 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS Initial or Prolonged Leukopenia Health Venlafaxine C Neutropenia Professional Suicide Attempt Tachycardia Date:09/08/98ISR Number: 3127197-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Zyprexa PS 5 MG AM, 20 MG HS Paxil C Lasix C Oxycodone C Aldactone C Colace C Augmentin C Nph Humulin C Reg. Humulin C 24-Jun-2005 12:19 PM Page: 421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/98ISR Number: 3127200-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Zyprexa PS 20 MG HS Haldol C Congentin C Paxil C Pepcid C Depakote C Ortho-Novum C Date:09/09/98ISR Number: 3126604-4Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Amylase Increased Olanzapine PS Lilly ORAL 20MG PO DAY Hospitalization - Blood Creatine Paroxetine C Initial or Prolonged Phosphokinase Increased Clonazepam C Coma Heart Rate Increased Heart Rate Irregular Hypotension Liver Function Test Abnormal Pneumonia Aspiration Pyrexia Respiratory Distress Tachypnoea Vomiting Date:09/09/98ISR Number: 3127299-6Report Type:Expedited (15-DaCompany Report #US_980707097 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatitis A Health Zyprexa PS 20 MG/DAY 5 MON Hepatitis B Professional Depakote C Hepatitis C Neurontin C Liver Function Test Abnormal Date:09/09/98ISR Number: 3127302-3Report Type:Expedited (15-DaCompany Report #US_980808185 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Study Zyprexa PS 30 MG DAY Initial or Prolonged Condition Aggravated Health Delusional Disorder, Professional Persecutory Type Drug Ineffective Elevated Mood Date:09/09/98ISR Number: 3127303-5Report Type:Expedited (15-DaCompany Report #US-980706345 Age:70 YR Gender:Male I/FU:F Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Health Zyprexa PS 5 MG/DAY Agitation Professional Oncovin SS Ascites Neupogen C Condition Aggravated Restoril C Confusional State Vicodin C Convulsion Glucotrol C Delirium Atarax C Grand Mal Convulsion Insulin C Hyponatraemia Cyclophosphamide C Lethargy Doxorubicin C Mental Impairment Prednisone C Neutropenia Oedema Pancytopenia Pleural Effusion Pneumonia Pneumonia Klebsiella Sepsis Date:09/09/98ISR Number: 3127376-XReport Type:Expedited (15-DaCompany Report #GBS980500590 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Other Procyclidine C Trifluoperazine C Zuclopenthixol C Date:09/09/98ISR Number: 3127380-1Report Type:Expedited (15-DaCompany Report #EWC980600765 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Zyprexa PS 22.5 MG/DAY Hospitalization - Distress Syndrome Health Haloperidol C Initial or Prolonged Aspiration Professional Akineton C Bronchopneumonia Other Lexaurin C Cyanosis Electrolyte Imbalance Femoral Neck Fracture Fungal Infection Fungal Sepsis Heart Rate Increased Hypokalaemia Hyponatraemia Hypotension Loss Of Consciousness Muscle Rigidity Restlessness Sepsis Tremor Urinary Incontinence Vomiting Water Intoxication 24-Jun-2005 12:19 PM Page: 423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/98ISR Number: 3127383-7Report Type:Expedited (15-DaCompany Report #EWC980801270 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prothrombin Level Foreign Zyprexa PS Initial or Prolonged Decreased Health Citalopram C Professional Remid C Other Chloraldurat C Digimerck C Marcumar C Adumbran C Date:09/09/98ISR Number: 3128149-4Report Type:Expedited (15-DaCompany Report #1028256A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Systolic Literature Acetaminophen PS ORAL PO Hospitalization - Decreased Health Valproic Acid SS ORAL PO Initial or Prolonged Completed Suicide Professional Olanzapine SS Hypotension Intentional Misuse Mydriasis Tachycardia Date:09/10/98ISR Number: 3126746-3Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Zyprexa PS ORAL 10-20MG PO 7 DAY Euphoric Mood Ativan C Social Avoidant Behaviour Cogentin C Depakote C Date:09/14/98ISR Number: 3129405-6Report Type:Expedited (15-DaCompany Report #US_980909641 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Zyprexa PS 10 MG/1 DAY Lymphadenopathy Professional Wellbutrin Neoplasm Malignant (Amfebutamone Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Date:09/14/98ISR Number: 3129962-XReport Type:Expedited (15-DaCompany Report #GBS980500590 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa (Olanzapine) PS Procyclidine C Trifluoperazine C Zuclopenthixol C 24-Jun-2005 12:19 PM Page: 424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/98ISR Number: 3129965-5Report Type:Expedited (15-DaCompany Report #GBS980801366 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Foreign Zyprexa PS 10 MG/1 DAY Hepatic Fibrosis Health Liver Function Test Professional Abnormal Date:09/14/98ISR Number: 3129968-0Report Type:Expedited (15-DaCompany Report #DE_980800372 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Zyprexa PS 20 MG DAY Initial or Prolonged Abnormal Health Fluphenazine C Thrombocytopenia Professional Date:09/14/98ISR Number: 3129971-0Report Type:Expedited (15-DaCompany Report #US_980809379 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Consumer Zyprexa PS 5 MG/1 DAY Initial or Prolonged Health Atenolol C Professional Company Representative Date:09/14/98ISR Number: 3237833-3Report Type:Periodic Company Report #US98011948A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypoventilation Health Brevital Professional (Methohexital Sodium) PS Zyprexa (Olanzapine) SS Date:09/15/98ISR Number: 3129389-0Report Type:Expedited (15-DaCompany Report #EWC980901420 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Hypervolaemia Health Tolvon C Hyponatraemia Professional Water Intoxication Company Representative Date:09/15/98ISR Number: 3129409-3Report Type:Expedited (15-DaCompany Report #US_980909432 Age:13 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Haematocrit Decreased Other Haemoglobin Decreased Leukaemia Leukopenia Lymphocyte Count Increased 24-Jun-2005 12:19 PM Page: 425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Monocyte Count Increased Neutrophil Count Decreased Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS 20 MG/1 DAY Decreased Professional Adderall C Date:09/15/98ISR Number: 3129415-9Report Type:Expedited (15-DaCompany Report #US_980809280 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Zyprexa PS 5 MG/1 DAY 1 WK Professional Clozaril C Lithium C Serzone C Cogentin C Date:09/15/98ISR Number: 3129420-2Report Type:Expedited (15-DaCompany Report #US_980808272 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Foreign Olanzapine PS 5 MG/ D DAY Initial or Prolonged Abnormal Study Insomnia Health Intentional Misuse Professional Sedation Date:09/15/98ISR Number: 3129433-0Report Type:Expedited (15-DaCompany Report #DE-980700205 Age:4 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa PS 20 MG/1 DAY Initial or Prolonged Hepatitis Health Minisiston C Hepatitis Cholestatic Professional Tavor C Hepatomegaly Other Jaundice Pruritus Date:09/15/98ISR Number: 3129917-5Report Type:Expedited (15-DaCompany Report #US98014615A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Health Zyprexa (Olanzapine) PS 5MG / 1 DAY Completed Suicide Professional Erythromicin C Overdose Zovirax C Trazodone C Depakote C Semisodium C Date:09/17/98ISR Number: 3131063-1Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Other Agitation Delusion Hallucination, Auditory Insomnia 24-Jun-2005 12:19 PM Page: 426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Paranoia Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS ORAL 5 MG QD 2 DAY Parnate SS ORAL 20 MG 4 X PER DAY PO 13 YR Trazodone C Ambien C Date:09/18/98ISR Number: 3132260-1Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Zyprexa PS Lilly ORAL 10 MG HS ORAL Benztropine C Insulin C Lansoprazole C Lisinopril C Maalox C Date:09/18/98ISR Number: 3132262-5Report Type:Direct Company Report # Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Zyprexa PS Lilly ORAL 5 MG HS ORAL Alprazolam C Captopril C Diltiazem C Fluvastatin C Sertraline C Ibuprofen C Thoridazine C Trazodone C Date:09/18/98ISR Number: 3132263-7Report Type:Direct Company Report # Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Palpitations Zyprexa PS Lilly ORAL 10 MG HS ORAL Doxazosin C Lisinopril C Date:09/18/98ISR Number: 3132265-0Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Zyprexa PS Lilly ORAL 20 MG HS PO Apap C Albuterol C Beclomethasone C Benztropine C Calcium Polycarbophil C Cimetidine C Diphenhydramine C Fluphenazine C Lisinopril C 24-Jun-2005 12:19 PM Page: 427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Theophylline C Date:09/18/98ISR Number: 3132266-2Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS Lilly ORAL 5 MG HS ORAL Fatigue Professional Clonazepam C Feeling Abnormal Ibuprofen C Sedation Date:09/18/98ISR Number: 3132267-4Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Lilly ORAL 10 MG HS ORAL Professional Benztropine C Hydroxyzine C Date:09/18/98ISR Number: 3132268-6Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS Lilly ORAL 5 MG HS ORAL Crying Professional Zyprexa SS Lilly ORAL 10 MG HS ORAL Insomnia Nervousness Restlessness Date:09/18/98ISR Number: 3132269-8Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Lilly SEE IMAGE Drug Ineffective Professional Amantadine C Hypotension Ec Asa C Digoxin C Diphenhydramine C Glyburide C Famotidine C L-Thyroxine C Lico3 C Venlafaxine C Ntg Patch C Date:09/18/98ISR Number: 3132270-4Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Health Zyprexa PS Lilly ORAL 5 MG HS ORAL Professional Apap C Maalox C Beclomethosone C Docusate C Famotidine C 24-Jun-2005 12:19 PM Page: 428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metoprolol C Ibuprofen C Multi-Vitamins C Lorazepam C Thyroid C Thiamine C Psyllium C Date:09/18/98ISR Number: 3132271-6Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Lilly SEE B5 Professional SEE IMAGE Caco3 C Warfarin C Date:09/18/98ISR Number: 3132272-8Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Zyprexa PS Lilly ORAL 5 MG HS ORAL Professional Fluoxetine C Trazodone C Miltivitamin (Minerals) C Date:09/18/98ISR Number: 3132273-XReport Type:Direct Company Report # Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flushing Health Zyprexa PS Lilly ORAL 5 MG HS ORAL Tremor Professional Clonazepam C Divalproex C Docusate C Lisinopril C Metipranolol C Prazosin C Sertraline C Simvastatin C Thiamine C Vit E C Date:09/18/98ISR Number: 3132275-3Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS Lilly ORAL 10 MG HS ORAL Dyspnoea Professional Albuterol C Maalox C Aspirin C Benztropine C Famotidine C Felodipine C Psyllium C 24-Jun-2005 12:19 PM Page: 429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/98ISR Number: 3132461-2Report Type:Expedited (15-DaCompany Report #F/98/01272/LEX Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Leponex PS ORAL 700 MG ORAL Initial or Prolonged Anxiety Professional Zyprexa SS ORAL 10 MG ORAL Required Bronchial Obstruction Hept-A-Myl C Intervention to Cholinergic Syndrome Barnetil C Prevent Permanent Confusional State Loxapac C Impairment/Damage Disorientation Drug Ineffective Drug Withdrawal Syndrome Dyskinesia Dyspnoea Enuresis Extrapyramidal Disorder Hyperhidrosis Increased Bronchial Secretion Lung Disorder Pleural Infection Pneumonia Productive Cough Pyrexia Tremor Date:09/20/98ISR Number: 3133370-5Report Type:Expedited (15-DaCompany Report #US_980809379 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Consumer Zyprexa PS 5 MG/1 DAY Initial or Prolonged Health Intal (Cromoglicate Professional Sodium) C Company Proventil Representative (Salbutamol) C Date:09/20/98ISR Number: 3133373-0Report Type:Expedited (15-DaCompany Report #US_980808450 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Acute Health Zyprexa PS 20 MG/DAY Professional Risperdal (Risperidone) C Vasotec (Enalapril Maleate) C Date:09/20/98ISR Number: 3133375-4Report Type:Expedited (15-DaCompany Report #GBS980801175 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Injury Foreign Zyprexa PS Chest Injury Health Laboratory Test Abnormal Professional Road Traffic Accident Other 24-Jun-2005 12:19 PM Page: 430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/98ISR Number: 3132986-XReport Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Zyprexa Tablets Coordination Abnormal (Olanzapine) PS Eli Lilly And Co Date:09/21/98ISR Number: 3133178-0Report Type:Expedited (15-DaCompany Report #DE_980700273 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 15 MG /D DAY Initial or Prolonged Health Dipiperon Professional (Pipamperone) C Date:09/21/98ISR Number: 3133181-0Report Type:Expedited (15-DaCompany Report #US_980909729 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Health Zyprexa PS 7.5 MG/DAY Initial or Prolonged Inversion Professional Depakote (Valprote Hyperhidrosis Semisodium) C Pallor Isoniazid C Sedation Anafranil (Clomipramine Hydrochloride) C Pyrodoxine C Ibuprofen C Date:09/21/98ISR Number: 3133183-4Report Type:Expedited (15-DaCompany Report #US_980909725 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Health Zyprexa PS 5 MG/1 DAY Initial or Prolonged Inversion Professional Prozac SS 8 MG /DAY Depakote (Valproate Semisodium) C Ibuprofen C Date:09/21/98ISR Number: 3133377-8Report Type:Expedited (15-DaCompany Report #JP97010424A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Foreign Zyprexa PS 12.5 MG DAY Akathisia Study Nitrazepam C Anaemia Health Haloperidol C Dizziness Professional Sennoside C Faeces Discoloured Company Gastric Ulcer Representative Gastrointestinal Haemorrhage Hypotension Melaena Pyrexia 24-Jun-2005 12:19 PM Page: 431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/98ISR Number: 3133379-1Report Type:Expedited (15-DaCompany Report #US_980707483 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS 10 MG/DAY 10 MON Professional Prolixin Decanoate (Fluphenazine Decanoate) C Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Artane (Trihexyphenidyl Hydrochloride) C Date:09/21/98ISR Number: 3133452-8Report Type:Expedited (15-DaCompany Report #US_980808185 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Study Zyprexa PS 30 MG/DAY Initial or Prolonged Condition Aggravated Health Drug Ineffective Professional Paranoia Date:09/21/98ISR Number: 3133453-XReport Type:Expedited (15-DaCompany Report #GBS980701030 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zyprexa PS 10 MG DAY Health Neurontin Professional (Gabapentin) C Other Camcolit (Lithium Carbonate) C Epilim Chronon (Valprate Sodium) C Dolmatil (Sulpiride) C Liothyronine C Zimovane (Zopiclone) C Date:09/21/98ISR Number: 3133454-1Report Type:Expedited (15-DaCompany Report #US_980808115 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Zyprexa PS 30 MG/DAY Drug Interaction Professional Lithium C Drug Level Above Premarin (Estrogens Therapeutic Conjugated) C Hepatic Congestion Atrovent Overdose (Ipratropium Pulmonary Congestion Bromide) C Renal Disorder Depakote (Valproate Ventricular Hypertrophy Semisodium) C Ranitidine C 24-Jun-2005 12:19 PM Page: 432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/98ISR Number: 3133502-9Report Type:Expedited (15-DaCompany Report #US_980909713 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa (Olanzapine) PS Initial or Prolonged Congestive Professional Depakote C Other Electrocardiogram T Wave Paxil C Inversion Coumadin C Oedema Peripheral Date:09/22/98ISR Number: 3133131-7Report Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Zyprexa PS Lilly ORAL 7.5MG PO HS Initial or Prolonged Clonazepam C Trazodone C Date:09/22/98ISR Number: 3134274-4Report Type:Expedited (15-DaCompany Report #044-0945-980059 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Neurontin PS ORAL 3200 MG (1600 Health MG, BID) PER Professional ORAL Zyprexa SS ORAL 10 MG DAILY PER ORAL Camcolit (Lithium Carbonate) C Epilim (Valproate Sodium) C Dolmatil (Sulpiride) C Tertroxin (Liothyronine Sodium) C Zimovane (Zopiclone) C Date:09/23/98ISR Number: 3133950-7Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Body Temperature Olanzapine PS Intervention to Increased Prevent Permanent Impairment/Damage Date:09/23/98ISR Number: 3133951-9Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Haloperidol PS Intervention to Syndrome Benztropine SS ORAL 1 MG TAB Prevent Permanent PO/IM Impairment/Damage Olanzapine SS ORAL 5 M TAB PO 24-Jun-2005 12:19 PM Page: 433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/98ISR Number: 3133954-4Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Mania Olanzapine PS Intervention to Prevent Permanent Impairment/Damage Date:09/28/98ISR Number: 3135735-4Report Type:Expedited (15-DaCompany Report #US_980910231 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Zyprexa PS 10 MG/1 DAY Initial or Prolonged Catatonia Professional Haldol (Haloperidol) C Other Circulatory Collapse Other Ativan C Coma Cyanosis Dehydration Depression Date:09/28/98ISR Number: 3136134-1Report Type:Expedited (15-DaCompany Report #GBS980500603 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexra PS Circulatory Collapse Health Deipixol Professional (Flupentixol Company Decanoate) C Representative Sulpiride C Other Date:09/28/98ISR Number: 3136137-7Report Type:Expedited (15-DaCompany Report #CA_980800106 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Foreign Zyprexa PS 10 MG/1 DAY Initial or Prolonged Health Epival (Valproate Disability Professional Semisodium) C Temazepam C Date:09/28/98ISR Number: 3136139-0Report Type:Expedited (15-DaCompany Report #US_980808047 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Zyprexa PS 10 MG/DAY Myocardial Infarction Professional Clozaril (Clozapine0 C Weight Increased Buspar (Buspirone Hydrochloride) C Date:09/28/98ISR Number: 3136142-0Report Type:Expedited (15-DaCompany Report #DE_980800374 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Health Iburprofen C Professional Akineton Retard 24-Jun-2005 12:19 PM Page: 434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Biperiden Hydrochloride) C Diazepam C Date:09/28/98ISR Number: 3136144-4Report Type:Expedited (15-DaCompany Report #DE_980800331 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Zyprexa PS 10 MG DAY Hospitalization - Cyanosis Health Serdolect Initial or Prolonged Drug Effect Decreased Professional (Sertindole) SS 20 MG DAY Dyspnoea Other Melleril Venous Stasis Thioridazine Hydrochloride) C Oral Contraceptive Nos C Frisium (Clobazam) C Glucobay (Acarbose) C Corvaton (Molsidomine) C Tenormin (Atenolol) C Amaryl (Glimepiride) C Glucophage (Metformin Hydrochloride0 C Ximovan (Zopiclone) C Date:09/28/98ISR Number: 3136379-0Report Type:Expedited (15-DaCompany Report #AU_980900228 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS UNKNOWN UNKNOWN Confusional State Health Ventricular Fibrillation Professional Other Date:09/28/98ISR Number: 3136381-9Report Type:Expedited (15-DaCompany Report #EWC980801234 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Rupture Foreign Zyprexa PS UNKNOWN 10 MG DAY Cardiac Arrest Health UNKNOWN Malaise Professional Tegretol (Carbamazepine) C Imovane (Zopiclone) C Date:09/28/98ISR Number: 3136384-4Report Type:Expedited (15-DaCompany Report #DE_980900407 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Foreign Zyprexa PS UNKNOWN 10 MG DAY AND Abnormal Health 20 MG DAY Fatigue Professional UNKNOWN Parkinsonism Pres (Enalapril Shock Maleate) C Tremor 24-Jun-2005 12:19 PM Page: 435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/98ISR Number: 3136386-8Report Type:Expedited (15-DaCompany Report #GBS980600766 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa PS UNKNOWN 1000 MG Initial or Prolonged Delusion Health UNKNOWN Drug Ineffective Professional Electrocardiogram Company Abnormal Representative Hyponatraemia Other Loss Of Consciousness Muscle Twitching Overdose Paranoia Suicidal Ideation Date:09/28/98ISR Number: 3136389-3Report Type:Expedited (15-DaCompany Report #GBS980901472 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Tactile Foreign Zyprexa PS UNKNOWN 140 MG Initial or Prolonged Hallucinations, Mixed Health UNKNOWN Intentional Misuse Professional Company Representative Date:09/28/98ISR Number: 3136392-3Report Type:Expedited (15-DaCompany Report #GBS980901479 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa PS UNKNOWN 15 MG DAY Initial or Prolonged Vomiting Health UNKNOWN Professional Other Date:09/28/98ISR Number: 3136394-7Report Type:Expedited (15-DaCompany Report #AU_980900225 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa PS UNKNOWN 10 MG/DAY Bronchopneumonia UNKNOWN Drug Interaction Fluconazole C Sedation Nefazodone C Cisapride C Valproate Sodium C Liothyronine Sodium C Date:09/28/98ISR Number: 3136399-6Report Type:Expedited (15-DaCompany Report #CA97015884A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS UNKNOWN 10 MG 1 DAY Hospitalization - Oedema Genital Health UNKNOWN Initial or Prolonged Priapism Professional Acetazolamide C Disability Testicular Pain Ranitidine C Docusate Calcium C Ventolin (Salbutamol) C 24-Jun-2005 12:19 PM Page: 436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Becloforte (Beclometasone Dipropionate) C Date:09/28/98ISR Number: 3234298-2Report Type:Periodic Company Report #9805976 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Norvasc Tablets PS ORAL 5.00MG TOTAL Depression DAILY ORAL Drug Ineffective Antidepressants SS ORAL ORAL Face Oedema Zyprexa SS ORAL ORAL Gastrointestinal Disorder Paxil SS ORAL ORAL Headache Tenormin C Oedema Oedema Peripheral Sedation Thinking Abnormal Date:10/02/98ISR Number: 3259883-3Report Type:Periodic Company Report #7396468 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Health Abbott - Depakote PS Abbott Inversion Professional Olanzapine SS Date:10/02/98ISR Number: 3260389-6Report Type:Periodic Company Report #7396127 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Abbott - Depakote PS ORAL 750.000 MG PO Drug Interaction Professional QD Hostility Company Zyprexa SS ORAL 2.500 MG PO Insomnia Representative QD Mania Date:10/02/98ISR Number: 3260398-7Report Type:Periodic Company Report #7396469 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Health Abbott - Depakote PS Abbott Inversion Professional Olanzapine SS Date:10/02/98ISR Number: 3260401-4Report Type:Periodic Company Report #7396470 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Health Abbott-Depakote PS Abbott Inversion Professional Olanzapine SS 24-Jun-2005 12:19 PM Page: 437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/98ISR Number: 3260576-7Report Type:Periodic Company Report #7396329 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Health Abbott - Depakote PS Abbott ORAL 2.500GM PO QD Inversion Professional Olanzapine SS ORAL PO QD Oedema Peripheral Prozac C Date:10/02/98ISR Number: 3260577-9Report Type:Periodic Company Report #7396128 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Abbott - Depakote PS Abbott ORAL 500.00 MG PO Drug Interaction Professional BID Hostility Company Zyprexa SS ORAL 2.500 MG PO Insomnia Representative BID Mania Date:10/02/98ISR Number: 3260583-4Report Type:Periodic Company Report #7396131 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Abbott - Depakote PS Abbott Drug Interaction Professional Zyprexa SS Hostility Company Trazodone C Insomnia Representative Mania Date:10/02/98ISR Number: 3260645-1Report Type:Periodic Company Report #7396258 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Health Abbott - Depakote PS Abbott ORAL 2.500GM PO QD Dehydrogenase Increased Professional Zyprexa SS ORAL PO QD Drug Interaction Other Ibuprofen C Electrocardiogram Abnormal Date:10/05/98ISR Number: 3138038-7Report Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Olanzapine (Zyprexa) PS ORAL 12.5MG P.O. 9 MON Initial or Prolonged Dystonia Cogentin C ORAL 0.5MG BID Eye Rolling Depakote C ORAL 250MG AM, Neuroleptic Malignant 500MG QHS Syndrome Paxil C ORAL 40MG AM Parkinson'S Disease Multivits C Salivary Hypersecretion Tachycardia Urinary Incontinence 24-Jun-2005 12:19 PM Page: 438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/98ISR Number: 3138109-5Report Type:Expedited (15-DaCompany Report #US_980808272 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Foreign Olanzapine PS 5 MG/ D DAY Initial or Prolonged Drug Toxicity Study Insomnia Health Intentional Misuse Professional Sedation Other Date:10/05/98ISR Number: 3138113-7Report Type:Expedited (15-DaCompany Report #EWC980901529 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa PS 5MG DAY 2 WK Completed Suicide Health Lysanxia C Professional Company Representative Other Date:10/05/98ISR Number: 3138116-2Report Type:Expedited (15-DaCompany Report #CA 980900168 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocyte Count Foreign Zyprexa PS 5MG Initial or Prolonged Decreased Health Asa C White Blood Cell Count Professional Ativan C Increased Other Date:10/05/98ISR Number: 3138243-XReport Type:Expedited (15-DaCompany Report #DE98024252A Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS 20MG DAY Life-Threatening Cardio-Respiratory Arrest Health Carbamazepine C Professional Lorazepam C Other Halloperidol C Acetylsalicylic C Isosorbide C Dytide H C Date:10/05/98ISR Number: 3138289-1Report Type:Expedited (15-DaCompany Report #US_980910599 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS 20 MG/1 AT Cardio-Respiratory Arrest Professional BEDTIME Coma Haldol Decanoate C Coronary Artery Disease Hypertrophy Myocardial Fibrosis Swelling 24-Jun-2005 12:19 PM Page: 439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/98ISR Number: 3138291-XReport Type:Expedited (15-DaCompany Report #US_980910603 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS 10 MG/DAY Initial or Prolonged Health Professional Date:10/05/98ISR Number: 3138292-1Report Type:Expedited (15-DaCompany Report #US_980808019 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Zyprexa PS Completed Suicide Professional Drug Toxicity Intentional Misuse Ventricular Hypertrophy Date:10/05/98ISR Number: 3138294-5Report Type:Expedited (15-DaCompany Report #US 980909404 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Zyprexa PS 5MG/DAY Initial or Prolonged Dysarthria Professional Depakote C Date:10/05/98ISR Number: 3138295-7Report Type:Expedited (15-DaCompany Report #US_980910549 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Intracranial Health Zyprexa PS 20 MG/1 DAY Ruptured Cerebral Professional Zoloft C Aneurysm Date:10/05/98ISR Number: 3138297-0Report Type:Expedited (15-DaCompany Report #US_980808115 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Zyprexa PS 30MG DAY Drug Interaction Professional Lithium C Hepatic Congestion Atrovent C Overdose Depakate C Pulmonary Congestion Ranitidine C Renal Disorder Ventricular Hypertrophy Date:10/05/98ISR Number: 3138298-2Report Type:Expedited (15-DaCompany Report #US_980910580 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Nerve Disorder Health Zyprexa PS Professional Effexor C Knonopin C Oral Contraceptive Nos C Levoxyl C Mellaril C 24-Jun-2005 12:19 PM Page: 440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/98ISR Number: 3138299-4Report Type:Expedited (15-DaCompany Report #GBS980700986 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Fall Health Hepatic Rupture Professional Intra-Abdominal Other Haemorrhage Leg Amputation Lower Limb Fracture Polytraumatism Schizophrenia Splenic Rupture Date:10/05/98ISR Number: 3138300-8Report Type:Expedited (15-DaCompany Report #EWC980600969 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Zyprexa PS 10MG DAY 3 MON Intestinal Obstruction Health Venlafaxine C Professional Company Representative Other Date:10/05/98ISR Number: 3138302-1Report Type:Expedited (15-DaCompany Report #DE 980900407 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Foreign Zyprexa PS 10MG DAY, Abnormal Health 20MG DAY Fatigue Professional Pres C Parkinson'S Disease Other Syncope Tremor Date:10/05/98ISR Number: 3138303-3Report Type:Expedited (15-DaCompany Report #CA_980800106 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Foreign Zyprexa PS 10MG / 1 DAY Initial or Prolonged Priapism Health Epival C Professional Temazepam C Other Date:10/05/98ISR Number: 3138902-9Report Type:Expedited (15-DaCompany Report #CA_980900157 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS 15 MG AT Initial or Prolonged Agitation Health BEDTIME Delusion Professional Risperidone C Hypomania Modecate (Fluphenazine Decanoate) C Cogentin (Benzatropine 24-Jun-2005 12:19 PM Page: 441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Date:10/05/98ISR Number: 3138904-2Report Type:Expedited (15-DaCompany Report #CA_980900158 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa PS 2.5 MG Initial or Prolonged Leukocytosis Health Luvox (Fluvoxamine Pancreatitis Acute Professional Maleate) C Date:10/05/98ISR Number: 3138935-2Report Type:Expedited (15-DaCompany Report #EWC980901575 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Zyprexa PS 10 MG/DAY Cardiac Failure Health Truxal C Professional Company Representative Date:10/05/98ISR Number: 3138982-0Report Type:Expedited (15-DaCompany Report #US_980910821 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adrenocortical Foreign Zyprexa PS 1 DAY Insufficiency Acute Literature Risperidone C Cellulitis Health Confusional State Professional Depressed Level Of Consciousness Hypothalamo-Pituitary Disorders Hypothermia Date:10/06/98ISR Number: 3138629-3Report Type:Expedited (15-DaCompany Report #USA004722 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Meridia PS ORAL 10 MG OD PO Syndrome Professional Olanzapine SS UNKNOWN UNK Date:10/06/98ISR Number: 4462833-5Report Type:Direct Company Report #USP 51852 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec (Zypexa Sent Instead) PS Pfizer TAB Zyprexa 10 SS Lilly TAB Date:10/07/98ISR Number: 3139445-9Report Type:Expedited (15-DaCompany Report #7396988 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Health Depakote PS ORAL 2.500 GM PO Initial or Prolonged Inversion Professional QD Other Other Zyprexa SS 5.000 MG QD 24-Jun-2005 12:19 PM Page: 442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prozac C Ibuprofen C Date:10/13/98ISR Number: 3141032-3Report Type:Expedited (15-DaCompany Report #IE97080998A Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa PS 10 MG Initial or Prolonged Priapism Health Thioridazine C Professional Flurazepam C Normison C Date:10/13/98ISR Number: 3141691-5Report Type:Expedited (15-DaCompany Report #CA_980900168 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocyte Count Foreign Zyprexa PS 5 MG Initial or Prolonged Decreased Health Asa C White Blood Cell Count Professional Ativan C Decreased Ntg C Enalapril C K-Dur C Digoxin C Sertraline C Lasix C Date:10/13/98ISR Number: 3141920-8Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Olanzapine PS ORAL 2.5 MG QHS Date:10/13/98ISR Number: 3141938-5Report Type:Direct Company Report # Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Olanzapine (Zyprexa) PS 5 MG QHS Required First Degree 8/4-8/6 THEN Intervention to Electrocardiogram Qt 10 MG QHS Prevent Permanent Prolonged 8/7-8/8 Impairment/Damage Hyperhidrosis Hypotension Sinus Bradycardia Date:10/13/98ISR Number: 3142017-3Report Type:Expedited (15-DaCompany Report #DE_980900455 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Zyprexa PS 200MG DAY Initial or Prolonged Overdose Health Tachycardia Professional 24-Jun-2005 12:19 PM Page: 443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/98ISR Number: 3142044-6Report Type:Expedited (15-DaCompany Report #US_981011167 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Zyprexa PS 2.5 MG/2 DAY 1 MON Urinary Tract Infection Professional Dilantin C Cardizem C Isordil C Ativan C Buspar C Vitamin E C Metamucil C Date:10/13/98ISR Number: 3142046-XReport Type:Expedited (15-DaCompany Report #US97052320A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Zyprexa PS 5 MG/ 1 DAY Professional Buspar C Date:10/13/98ISR Number: 3142108-7Report Type:Expedited (15-DaCompany Report #US 980910969 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa PS 20MG / 1 DAY 2 YR Initial or Prolonged Oedema Professional Lithium C Respiratory Depression Date:10/13/98ISR Number: 3142527-9Report Type:Expedited (15-DaCompany Report #CA_980900157 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa PS 15 MG AT Initial or Prolonged Anger Health BEDTIME Delusion Professional Risperidone C Hallucination Modecate C Hypomania Cogentin C Psychomotor Hyperactivity Date:10/13/98ISR Number: 3142530-9Report Type:Expedited (15-DaCompany Report #DE_980800331 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Zyprexa PS 10 MG DAY Hospitalization - Cholestasis Health Serdolect SS 20 MG DAY Initial or Prolonged Cyanosis Professional Melleril C Dyspnoea Other Oral Contraceptive Hepatic Steatosis Nos C Necrosis Frisium C Pulmonary Oedema Glucobay C Shock Corvaton C Venous Stasis Tenormin C Amaryl C Glucophage C Ximovan C 24-Jun-2005 12:19 PM Page: 444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/98ISR Number: 3142531-0Report Type:Expedited (15-DaCompany Report #DE_980700236 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS Initial or Prolonged Lymphadenopathy Health Phenothiazine C Pharyngitis Professional Pyrexia Date:10/13/98ISR Number: 3142532-2Report Type:Expedited (15-DaCompany Report #EWC980901575 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Zyprexa PS 10 MG/DAY Right Ventricular Failure Health Truxal C Professional Company Representative Date:10/13/98ISR Number: 3142533-4Report Type:Expedited (15-DaCompany Report #GBS980700955 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Zyprexa PS 10 MG/1 DAY Life-Threatening Brain Hypoxia Health Paracetamol C Hospitalization - Brain Oedema Professional Ferrous Sulphate C Initial or Prolonged Cardiac Arrest Other Trifluoperazine C Circulatory Collapse Procyclidine C Confusional State Stemetil C Drug Level Below Therapeutic Electrocardiogram Qt Prolonged Electroencephalogram Abnormal Headache Hepatic Function Abnormal Overdose Pneumonia Pulse Absent Pyrexia Date:10/13/98ISR Number: 3144554-4Report Type:Expedited (15-DaCompany Report #US_980910835 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Health Zyprexa PS Exposure To Therapeutic Professional Drugs Renal Dysplasia Date:10/13/98ISR Number: 3144557-XReport Type:Expedited (15-DaCompany Report #GBS981001623 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Other Cardiac Failure Foreign Congestive Health Professional 24-Jun-2005 12:19 PM Page: 445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS 10 MG DAY Lactulose C Date:10/13/98ISR Number: 3144606-9Report Type:Expedited (15-DaCompany Report #US_980910808 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Health Zyprexa PS 20 MG / 1 DAY 3 MON Hospitalization - Abdominal Pain Professional Paxil (Paroxetine Initial or Prolonged Coma Hydrochloride) C Hyperglycaemia Infection Joint Stiffness Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Date:10/13/98ISR Number: 3144877-9Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Depalote PS Initial or Prolonged Increased Zyprexa SS Body Temperature Remeron C Increased Coma Confusional State Drug Level Above Therapeutic Intentional Misuse Sedation Suicide Attempt Tachycardia Date:10/14/98ISR Number: 3141029-3Report Type:Expedited (15-DaCompany Report #US_980910603 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Zyprexa PS 10 MG/DAY Initial or Prolonged Psychotic Disorder Health Professional Date:10/15/98ISR Number: 3142776-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Atrial Flutter Olanzapine PS ORAL 5MG PO QAM Dizziness Olanzapine SS ORAL 10 MG PO QPM Haematuria Supraventricular Tachycardia 24-Jun-2005 12:19 PM Page: 446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/98ISR Number: 3143969-8Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Nicotine Patch PS 1 DAILY Initial or Prolonged Orthostatic Hypotension Zyprexa SS Lilly ORAL 1 TABLET PO BID; TABLET 10 MG Depakote C Remeron C Date:10/19/98ISR Number: 3143163-0Report Type:Expedited (15-DaCompany Report #CA_980800122 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS 7.5 MG/AT Hospitalization - Phosphokinase Increased Health BEDTIME 1 DAY Initial or Prolonged Chorea Professional Haldol C Coma Drooling Dyskinesia Dysphagia Extrapyramidal Disorder Hyperhidrosis Hypertension Leukocytosis Muscle Rigidity Neuroleptic Malignant Syndrome Oculogyration Opisthotonus Pyrexia Salivary Hypersecretion Tachycardia Tachypnoea Trismus Urinary Incontinence Date:10/19/98ISR Number: 3143538-XReport Type:Expedited (15-DaCompany Report #US_981011167 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Zyprexa PS 2.5 MG/ 2 DAY 1 MON Urinary Tract Infection Professional Dilantin (Phenytoin Sodium) C Cardizem (Diltiazem Hydrochloride) C Isordil (Isosorbide Dinitrate) C Ativan (Lorazepam) C Buspar (Buspirone) C Vitamin E C Metamucil (Psyllium Hydrophilic Mucilloid) C 24-Jun-2005 12:19 PM Page: 447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/98ISR Number: 3143540-8Report Type:Expedited (15-DaCompany Report #DE_980900455 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Zyprexa PS 200 MG/DAY Initial or Prolonged Overdose Health Tachycardia Professional Date:10/19/98ISR Number: 3143541-XReport Type:Expedited (15-DaCompany Report #US_980910969 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS 20 MG/ 1 DAY 2 YR Initial or Prolonged Dyspnoea Professional Eskalith Cr (Lithium Oedema Peripheral Carbonate) C Pco2 Increased Prozac (Fluoxetine Respiratory Depression Hydrochloride) C Date:10/19/98ISR Number: 3143612-8Report Type:Expedited (15-DaCompany Report #EWC980701041 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS 20 MG/DAY Pain Health Temesta C Pericardial Effusion Professional Date:10/19/98ISR Number: 3143613-XReport Type:Expedited (15-DaCompany Report #US_980808047 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Zyprexa PS 10 MG/DAY Myocardial Infarction Professional Prozac SS 10 MG/DAY Weight Increased Clozaril (Clozapine) C Buspar (Buspirone Hydrochloride) C Tiazac (Dil/Tiazem Hydrochloride) C Date:10/19/98ISR Number: 3143657-8Report Type:Expedited (15-DaCompany Report #EWC981001688 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Zyprexa PS 10MG/DAY Initial or Prolonged Electrocardiogram Qt Health Madopar C Other Prolonged Professional Parlodel C Loss Of Consciousness Other Effortil C Ventricular Fibrillation Date:10/19/98ISR Number: 3143658-XReport Type:Expedited (15-DaCompany Report #EWC981001726 Age:41 YR Gender:Female I/FU:I Outcome PT Death Arrhythmia Hospitalization - Cyanosis Initial or Prolonged Dyspnoea Electrolyte Imbalance Hyperkalaemia 24-Jun-2005 12:19 PM Page: 448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Hypotension Malaise Report Source Product Role Manufacturer Route Dose Duration Myalgia Foreign Zyprexa PS Health Clomipramine C Professional Thyrax C Propranolol C Lithium C Date:10/19/98ISR Number: 3143659-1Report Type:Expedited (15-DaCompany Report #GBS981001694 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa PS 5MG DAY Health Pergolide C Professional Other Date:10/19/98ISR Number: 3143660-8Report Type:Expedited (15-DaCompany Report #DE_981000478 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Zyprexa PS 10MG / 1 DAY 8 WK Initial or Prolonged Health Madopar C Professional Other Date:10/19/98ISR Number: 3143661-XReport Type:Expedited (15-DaCompany Report #US_981011209 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Professional Clonazepam C Alcohol C Date:10/19/98ISR Number: 3143662-1Report Type:Expedited (15-DaCompany Report #US_980910968 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa PS 30MG / 1 DAY Initial or Prolonged Hypercapnia Professional Klonopin C Pulmonary Oedema Zoloft C Respiratory Depression Lasix C Potassium C Prilosec C Synthroid C Arimidex C Date:10/19/98ISR Number: 3143663-3Report Type:Expedited (15-DaCompany Report #GBS981001695 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Initial or Prolonged Exposure To Therapeutic Consumer Dothiepin C Drugs Other Mebeverine C Haemorrhage 24-Jun-2005 12:19 PM Page: 449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/98ISR Number: 3143664-5Report Type:Expedited (15-DaCompany Report #US_981011483 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa PS 10MG / 2 DAY Professional Clozaril C Ativan C Date:10/19/98ISR Number: 3143665-7Report Type:Expedited (15-DaCompany Report #US_981011415 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Consumer Zyprexa PS 10MG / 1 DAY Breast Hyperplasia Health Klonopin C Breast Mass Professional Breast Pain Breast Tenderness Calcinosis Depression Fibroadenoma Of Breast Fibrocystic Breast Disease Headache Menstrual Disorder Premenstrual Syndrome Date:10/19/98ISR Number: 3143666-9Report Type:Expedited (15-DaCompany Report #US_981011228 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Zyprexa PS 2.5MG / 1 DAY 3 DAY Initial or Prolonged Supraventricular Professional Verapamil C Atrial Flutter Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Urea Increased Dehydration Fall Hyponatraemia Mental Disorder Neuroleptic Malignant Syndrome Pyrexia Renal Failure Rhabdomyolysis Urinary Retention White Blood Cell Count Increased Date:10/19/98ISR Number: 3144285-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Euphoric Mood Olanzapine PS ORAL 20 MG PO/DAY Initial or Prolonged Medication Error Colace C Sedation Lactulose C Nifedipine C 24-Jun-2005 12:19 PM Page: 450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamins C Terbinafine C Milk Of Magnesia C Hydroxyzine C Date:10/21/98ISR Number: 3144724-5Report Type:Direct Company Report #US 980707473 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Olanzapine PS 5MG/DAY Lithium C Date:10/21/98ISR Number: 3144743-9Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Zyprexa PS Drug Toxicity Testicular Atrophy Date:10/21/98ISR Number: 3144757-9Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Zyprexa PS Coronary Artery Disease Drug Toxicity Endocardial Fibrosis Hepatomegaly Schizophrenia Splenomegaly Date:10/22/98ISR Number: 3145462-5Report Type:Expedited (15-DaCompany Report #WAES 98075129 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Vasotec PS ORAL 40 MG PO 5 YR Hospitalization - Health Olanzapine SS ORAL 20 MG PO Initial or Prolonged Professional Aspirin C Atenolol C Diltiazem C Doxazosin C Indapamide C Isosorbide-5-Mononit rate C Date:10/26/98ISR Number: 3147203-4Report Type:Expedited (15-DaCompany Report #EWC981001732 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemiparesis Foreign Zyprexa PS 5 MG/DAY Initial or Prolonged Loss Of Consciousness Health Astrix C Professional Ticlid C Company Cavinton C Representative Tensiomin C Nitroderm C 24-Jun-2005 12:19 PM Page: 451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dopaflex C Insulin Monotard C Diabetes Mellitus C Actrapid C Date:10/26/98ISR Number: 3147205-8Report Type:Expedited (15-DaCompany Report #DE_981000460 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Zyprexa PS 400 MG/1 DAY Initial or Prolonged Dysarthria Health Motor Dysfunction Professional Overdose Sedation Suicide Attempt Vomiting Date:10/26/98ISR Number: 3147206-XReport Type:Expedited (15-DaCompany Report #AU_980900262 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Zyprexa PS 10 MG/DAY Health Alprazolam C Professional Paroxetine C Other Date:10/26/98ISR Number: 3147208-3Report Type:Expedited (15-DaCompany Report #EWC981001734 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa PS 10 MG/.DAY Initial or Prolonged Diabetes Mellitus Literature Clomipramine C Electrolyte Imbalance Health Hypercholesterolaemia Professional Hyperhidrosis Hypertriglyceridaemia Increased Appetite Thirst Date:10/26/98ISR Number: 3147209-5Report Type:Expedited (15-DaCompany Report #US 981011837 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Zyprexa PS 2.5 MG/ 1 DAY 2 WK Professional Sinemet C Date:10/26/98ISR Number: 3147210-1Report Type:Expedited (15-DaCompany Report #US 981011829 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Zyprexa PS 2.5 MG/ 1 DAY Initial or Prolonged Haemorrhage Professional Haldol C 24-Jun-2005 12:19 PM Page: 452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/98ISR Number: 3147213-7Report Type:Expedited (15-DaCompany Report #US 981011691 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa PS 5 MG/ 1 DAY Initial or Prolonged Confusional State Zoloft C Dizziness Depakote C Lethargy Psychotic Disorder Date:10/26/98ISR Number: 3147215-0Report Type:Expedited (15-DaCompany Report #US 981011475 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS Initial or Prolonged Delusion Other Risperidone SS Psychotic Disorder Date:10/26/98ISR Number: 3147217-4Report Type:Expedited (15-DaCompany Report #GBS981001705 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Health Ranitidine C Professional Chlorpromazine C Date:10/26/98ISR Number: 3147221-6Report Type:Expedited (15-DaCompany Report #EWC981001759 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS Initial or Prolonged Miosis Health Tranxene C Sedation Professional Suicide Attempt Date:10/26/98ISR Number: 3147222-8Report Type:Expedited (15-DaCompany Report #EWC981001733 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Overdose Health Haldol Depot C Professional Mitrazepam C Company Leponex C Representative Date:10/27/98ISR Number: 3147890-0Report Type:Expedited (15-DaCompany Report #US_980706540 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Zyprexa PS 20 MG/1 AT Coronary Artery Disease Professional BEDTIME Pleural Effusion Company Lithium Carbonate C Pneumonitis Representative Prolixin Decanoate C Pulmonary Congestion Pulmonary Oedema 24-Jun-2005 12:19 PM Page: 453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/98ISR Number: 3147891-2Report Type:Expedited (15-DaCompany Report #EWC981001726 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Hospitalization - Blood Creatinine Health Clomipramine C Initial or Prolonged Increased Professional Thyrax C Blood Glucose Increased Other Propranol C Blood Potassium Increased Lithium C Cyanosis Dyspnoea Electrocardiogram Qrs Complex Abnormal Electrolyte Imbalance Hepatosplenomegaly Hyperkalaemia Hypotension Malaise Metabolic Acidosis Muscle Rigidity Myalgia Respiratory Failure Tachycardia Date:10/27/98ISR Number: 3147893-6Report Type:Expedited (15-DaCompany Report #US_981011483 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa PS 10 MG/2 DAY Cardiac Arrest Professional Clozaril C Cardiac Disorder Ativan C Cardiomegaly Date:10/28/98ISR Number: 3149143-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Zoloft PS ORAL 100 MG PO QD Deficit/Hyperactivity Zyprexa SS ORAL 10 MG PO QD Disorder Delusional Disorder, Unspecified Type Nervousness Tremor Date:10/30/98ISR Number: 3256447-2Report Type:Periodic Company Report #US_980808203 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Skin Health Zyprexa (Olanzapine) PS 30 MG/DAY A Initial or Prolonged Intentional Misuse Professional FEW MONTHS Oedema Peripheral 24-Jun-2005 12:19 PM Page: 454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3256449-6Report Type:Periodic Company Report #US_980808222 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 5 MG/ D DAY Life-Threatening Health Buspar C Professional Paxil C Ativan C Date:10/30/98ISR Number: 3256451-4Report Type:Periodic Company Report #US_980808227 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Olanzapine PS 5 MG/ QAM IN Health THE MORNING Professional Aspirin C Paxil C Date:10/30/98ISR Number: 3256454-XReport Type:Periodic Company Report #US_980808261 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Study Olanzapine PS 5 MG/ D DAY Life-Threatening Health Levothyroxine C Hospitalization - Professional Motrin C Initial or Prolonged Tylenol C Date:10/30/98ISR Number: 3256460-5Report Type:Periodic Company Report #US_980808282 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 15 MG/ D DAY Initial or Prolonged Health Tenormin C Professional Date:10/30/98ISR Number: 3256464-2Report Type:Periodic Company Report #US_980808320 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Zyprexa (Olanzapine) PS 30 MG/DAY 7 MON Initial or Prolonged Intentional Misuse Lithium C Klonopin C Date:10/30/98ISR Number: 3256467-8Report Type:Periodic Company Report #US_980808323 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Health Placebo SS 2 MG/D DAY Professional Ativan C 24-Jun-2005 12:19 PM Page: 455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3256471-XReport Type:Periodic Company Report #US_980808369 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 15 MG/ DAY Syndrome Professional Berocca-C C Rhabdomyolysis Date:10/30/98ISR Number: 3256475-7Report Type:Periodic Company Report #US_980808391 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa (Olanzapine) PS 20 MG/ D DAY 46 DAY Initial or Prolonged Hallucination Health Micronase C Schizophreniform Disorder Professional Premarin C Vitamin E C Triamcinolone C Nizoral Skin Cream C Multivitamin C Date:10/30/98ISR Number: 3256478-2Report Type:Periodic Company Report #US_980808397 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 5 MG/ QHS AT Initial or Prolonged Dyspnoea Health BEDTIME Nausea Professional Captopril C Oedema Docusate C Ferrous Gluconate C Gemfibrozil C Hexavitamin C Isosorbide Dinitrate C Lansoprazole C Lovastatin C Metolazone C Potassium Chloride C Terazosin C Vitamin E C Acetaminophen C Clonazepam C Aluminium Magnesium Silicate C Magnesium Hydroxide C Promethazine C Albuterol C Ipratropium C Furosemide C Cyanocobalamin C Warfarin C Date:10/30/98ISR Number: 3256482-4Report Type:Periodic Company Report #US_980808453 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Health Professional Other 24-Jun-2005 12:19 PM Page: 456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3256485-XReport Type:Periodic Company Report #US_980808476 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Drug Ineffective Health Trazodone C Psychotic Disorder Professional Mellaril C Other Klonopin C Haldol C Date:10/30/98ISR Number: 3256487-3Report Type:Periodic Company Report #US_980808481 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Anxiety Health Mellaril C Psychotic Disorder Professional Other Date:10/30/98ISR Number: 3256488-5Report Type:Periodic Company Report #US_980808486 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Health Professional Other Date:10/30/98ISR Number: 3256489-7Report Type:Periodic Company Report #US_980808491 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Zyprexa (Olanzapine) PS Initial or Prolonged Suicide Attempt Health Risperdal C Thinking Abnormal Professional Luvox C Other Tegretol C Clonazepam C Hydrocodone C Date:10/30/98ISR Number: 3256492-7Report Type:Periodic Company Report #US_980808583 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Placebo PS Initial or Prolonged Depression Health Olanzapine SS Hallucinations, Mixed Professional Norvasc C Major Depression Date:10/30/98ISR Number: 3256496-4Report Type:Periodic Company Report #US_980808592 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Paranoia Health (Fluoxetine Professional Hydrochloride) PS Olanzapine SS 24-Jun-2005 12:19 PM Page: 457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3256498-8Report Type:Periodic Company Report #US_980808676 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Tegretol C Coma Depakote C Dyspnoea Anafranil C Extrapyramidal Disorder Zoloft C Nervousness Neuroleptic Malignant Syndrome Pyrexia Stupor Date:10/30/98ISR Number: 3256503-9Report Type:Periodic Company Report #US_980808739 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Study Olanzapine PS 2.5 MG/ D DAY Hospitalization - Health Lisinopril C Initial or Prolonged Professional Furosemide C Vitamin B12 C Folic Acid C Nifedipine C Meclizine C Artificial Tears C Levothyroxine C Digoxin C Multivitamin C Date:10/30/98ISR Number: 3256506-4Report Type:Periodic Company Report #US_980808743 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Zyprexa (Olanzapine) PS 375 MG Gastrointestinal Disorder Professional Depakote C Overdose Tachycardia Date:10/30/98ISR Number: 3257215-8Report Type:Periodic Company Report #US_980808791 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Olanzapine PS Initial or Prolonged Placebo SS Amlodipine C Cimetidine C Folic Acid C Thiamine C Multivitamin C Date:10/30/98ISR Number: 3257217-1Report Type:Periodic Company Report #US_980808884 Age:25 YR Gender:Male I/FU:I Outcome PT Hospitalization - Accident Initial or Prolonged Convulsion 24-Jun-2005 12:19 PM Page: 458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Professional Company Representative Date:10/30/98ISR Number: 3257219-5Report Type:Periodic Company Report #US_980808887 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG/D DAY Initial or Prolonged Hallucination Health Placebo SS 2 MG/ D DAY Insomnia Professional Lorazepam C Schizophreniform Disorder Date:10/30/98ISR Number: 3257220-1Report Type:Periodic Company Report #US_980808961 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa (Olanzapine) PS 525 MG/1 Initial or Prolonged Intentional Misuse Professional Klonopin C Pneumonia Aspiration Cogentin C Respiratory Disorder Sedation Tachycardia Date:10/30/98ISR Number: 3257221-3Report Type:Periodic Company Report #US_980809101 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Hallucination Professional Clozapine C Other Date:10/30/98ISR Number: 3257222-5Report Type:Periodic Company Report #US_980809150 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Depression Health Zoloft C Hallucination Professional Lithium C Other Alcohol C Cocaine C Date:10/30/98ISR Number: 3257223-7Report Type:Periodic Company Report #US_980809159 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Drug Ineffective Health Professional Other 24-Jun-2005 12:19 PM Page: 459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3257225-0Report Type:Periodic Company Report #US_980809192 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophreniform Disorder Study Olanzapine PS 10 MG/D DAY Health Placebo SS 2 MG/D DAY Professional Date:10/30/98ISR Number: 3257228-6Report Type:Periodic Company Report #US_980809222 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Zyprexa (Olanzapine) PS 5 MG/1 DAY 5 DAY Initial or Prolonged Hypertonia Professional Sinemet C Other Hyperventilation Terazosin C Neuroleptic Malignant Furosemide C Syndrome Fosinopril C Pyrexia Stupor Tachycardia Date:10/30/98ISR Number: 3257231-6Report Type:Periodic Company Report #US_980809346 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Zyprexa (Olanzapine) PS 5 MG/ 1 AT Initial or Prolonged Drug Level Above Professional BEDTIME Therapeutic Gabapentin C Salivary Hypersecretion Therapeutic Response Unexpected Date:10/30/98ISR Number: 3257239-0Report Type:Periodic Company Report #US_980909470 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Confusional State Professional Trilafon C Cogentin C Klonopin C Methadone C Date:10/30/98ISR Number: 3257242-0Report Type:Periodic Company Report #US_980909512 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 30 MG/DAY 6 MON Initial or Prolonged Hyperglycaemia Professional Other Intentional Misuse Sedation Speech Disorder Tongue Oedema 24-Jun-2005 12:19 PM Page: 460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3257246-8Report Type:Periodic Company Report #US_980909542 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG/HS AT Initial or Prolonged Health BEDTIME Professional Placebo SS Date:10/30/98ISR Number: 3257249-3Report Type:Periodic Company Report #US_980909548 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Study Olanzapine PS 5 MG/HS AT Initial or Prolonged Urinary Tract Infection Health BEDTIME Other Professional Fluoxetine (Fluoxetine Hydrochloride) SS 20 MG/D DAY Ativan C Diovan C Furosemide C Humulin N C Humulin N C Humulin R C Humulin R C Rezulin C Aspirin C Date:10/30/98ISR Number: 3257252-3Report Type:Periodic Company Report #US_980909624 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Olanzapine PS 2.5 MG/D DAY Initial or Prolonged Health Zoloft C Professional Trazodone C Sinemet C Mirapex C Magnesium C Calcium C Prempro C Date:10/30/98ISR Number: 3257256-0Report Type:Periodic Company Report #US_980909703 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Synthroid C Atenolol C Prilosec C Date:10/30/98ISR Number: 3257261-4Report Type:Periodic Company Report #US_980909773 Age:48 YR Gender:Male I/FU:I Outcome PT Hospitalization - Convulsion Initial or Prolonged Headache Hyponatraemia 24-Jun-2005 12:19 PM Page: 461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 10 MG/1 AT Professional BEDTIME Hydrochlorothiazide C Serzone C Prolixin C Lipitor C Neurontin C Cogentin C Xanax C Ultram C Viagra C Date:10/30/98ISR Number: 3257265-1Report Type:Periodic Company Report #US_980909827 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Albuminuria Health Zyprexa (Olanzapine) PS 15 MG/DAY Diabetes Mellitus Professional Zantac C Polyuria Doxepin C Tachycardia Thirst Date:10/30/98ISR Number: 3257268-7Report Type:Periodic Company Report #US_980909883 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Study Olanzapine PS Initial or Prolonged Health Professional Date:10/30/98ISR Number: 3257273-0Report Type:Periodic Company Report #US_980910023 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG/HS AT Initial or Prolonged Thinking Abnormal Health BEDTIME Professional Placebo SS 5 MG Date:10/30/98ISR Number: 3257441-8Report Type:Periodic Company Report #US_980910091 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Condition Aggravated Health Ibuoprofen C Mania Professional Ephedrine C Psychotic Disorder Date:10/30/98ISR Number: 3257442-XReport Type:Periodic Company Report #US_980910237 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Confusional State Health Initial or Prolonged Hyperglycaemia Professional 24-Jun-2005 12:19 PM Page: 462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Lithium Carbonate C Date:10/30/98ISR Number: 3257443-1Report Type:Periodic Company Report #US_980910267 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Health Professional Other Date:10/30/98ISR Number: 3257444-3Report Type:Periodic Company Report #US_980910372 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Study Olanzapine PS 2.5 MG; 5 MG Initial or Prolonged Health Rocephin C Professional Prednisone C Folic Acid C Synthroid C Oxycontin C Senokot C Diflucan C Date:10/30/98ISR Number: 3257447-9Report Type:Periodic Company Report #US_980910436 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 5 MG/D DAY Initial or Prolonged Hiccups Health Lithium C Sedation Professional Thorazine C Ativan C Date:10/30/98ISR Number: 3257449-2Report Type:Periodic Company Report #US_980910509 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 3 DAY Initial or Prolonged Phosphokinase Increased Professional Buccoglossal Syndrome Hypertension Leukocytosis Pyrexia Thinking Abnormal Date:10/30/98ISR Number: 3257451-0Report Type:Periodic Company Report #US_980910641 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Olanzapine PS Initial or Prolonged Health Risperidone C Professional Fluoketine C 24-Jun-2005 12:19 PM Page: 463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bactrim C Cogentin C Olanzapine C Colace C Benzoyl Peroxide C Cleocin C Date:10/30/98ISR Number: 3257453-4Report Type:Periodic Company Report #US_980910647 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Hallucination Health Prozac (Fluoxetine Insomnia Professional Hydrochloride) SS Paranoia Mellaril C Date:10/30/98ISR Number: 3257454-6Report Type:Periodic Company Report #US_980910655 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Health Placebo SS 2 MG/D DAY Professional Pyridoxine C Glyburide C Percocet C Ativan C Lisinopril C Isoniazid C Acetaminophen C Date:10/30/98ISR Number: 3257455-8Report Type:Periodic Company Report #US_980910707 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Health Placebo SS 2 MG/D DAY Professional Amlodipine C Cimetidine C Folic Acid C Mvi C Thiamine C Date:10/30/98ISR Number: 3257456-XReport Type:Periodic Company Report #US_980910730 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Health Zyprexa (Olanzapine) PS 5 MG/3 DAY Hospitalization - Increased Professional Prozac (Fluoxetine Initial or Prolonged Convulsion Other Hydrochloride) SS 20 MG/1 DAY Hypertonia Hypotension Neuroleptic Malignant Syndrome Pupillary Disorder Pyrexia Tachycardia 24-Jun-2005 12:19 PM Page: 464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3257457-1Report Type:Periodic Company Report #US_980910817 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Hyperglycaemia Professional Leukocytosis Date:10/30/98ISR Number: 3257458-3Report Type:Periodic Company Report #US_980910825 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 10 MG/HS AT Initial or Prolonged Health BEDTIME Professional Remeron C Levoxyl C Restoril C Milk Of Magnesia C Date:10/30/98ISR Number: 3257459-5Report Type:Periodic Company Report #US_980910827 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Study Olanzapine PS 5 MG/D DAY Life-Threatening Condition Aggravated Health Phosphates Enema C Professional Metronidazole C Tobramycin C Levofloxacin C Nitroglycerin C Captopril C Therapeutic Multivitamins C Aspirin C Amlodipine C Date:10/30/98ISR Number: 3257460-1Report Type:Periodic Company Report #US_980910840 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 7.5 MG/HS AT Initial or Prolonged Health BEDTIME Professional Date:10/30/98ISR Number: 3257462-5Report Type:Periodic Company Report #US_980910846 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Study Olanzapine PS Initial or Prolonged Health Placabo SS Professional Zantac C Hydrochlorothiazide C Atrovent C Serevent C Aerobid-M C Theodur Retard C Albuterol C Ocean Nasal Spray C 24-Jun-2005 12:19 PM Page: 465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3267435-4Report Type:Periodic Company Report #US_980910966 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY 1 DAY Professional Company Representative Date:10/30/98ISR Number: 3267438-XReport Type:Periodic Company Report #US_980910963 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Sedation Professional Acetaminophen C Lorazepam C Paxil C Levaquin C Date:10/30/98ISR Number: 3267443-3Report Type:Periodic Company Report #US_980910896 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS 15 MG/AT Initial or Prolonged Health BEDTIME AT Professional BEDTIME Date:10/30/98ISR Number: 3267449-4Report Type:Periodic Company Report #US_980808175 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Motrin C Professional Robaxin C Date:10/30/98ISR Number: 3267454-8Report Type:Periodic Company Report #US_980808159 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 30 MG DAY Initial or Prolonged Drug Ineffective Health Intentional Misuse Professional Date:10/30/98ISR Number: 3267457-3Report Type:Periodic Company Report #US_980808096 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 15 MG/DAY 2 MON Professional Prolixin C Date:10/30/98ISR Number: 3267462-7Report Type:Periodic Company Report #US_980808013 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Back Pain Health Initial or Prolonged Hypertonia Professional 24-Jun-2005 12:19 PM Page: 466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 20 MG/DAY Date:10/30/98ISR Number: 3267465-2Report Type:Periodic Company Report #US_980807860 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Hallucination Health Professional Date:10/30/98ISR Number: 3267468-8Report Type:Periodic Company Report #US_980807835 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Intentional Misuse Professional Depakene C Sedation Prolixin C Speech Disorder Tongue Oedema Date:10/30/98ISR Number: 3267471-8Report Type:Periodic Company Report #US_980707673 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Health Depakote C Professional Olanzapine C 10 MG/D DAY Depakote C Fluoxetine C Metamucil C Tylenol C Ultram C Prempro C Indocin C Date:10/30/98ISR Number: 3267473-1Report Type:Periodic Company Report #US_980707659 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Anxiety Health Lorazepam C Delusion Professional Photophobia Schizophreniform Disorder Date:10/30/98ISR Number: 3267475-5Report Type:Periodic Company Report #US_980707520 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Health Sinemet C Professional Inderal C Hytrin C 24-Jun-2005 12:19 PM Page: 467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyazide C Glynase C Elavil C Ativan C Restoril C Lotensin C Date:10/30/98ISR Number: 3267478-0Report Type:Periodic Company Report #US_980707499 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 7.5 MG/DAY 10 DAY Initial or Prolonged Hostility Health Famotidine C Professional Sertraline C Milk Of Magnesia C Maalox C Aricept C Acetaminophen C Docutase C Depakote C Lorazepam C Date:10/30/98ISR Number: 3267481-0Report Type:Periodic Company Report #US_980706738 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematuria Consumer Zyprexa (Olanzapine) PS 10 MG/DAY 2 WK Haldol C Vitamin C C Fibercon C Chlordiazepoxide C Vitamin E C Centrum C Date:10/30/98ISR Number: 3267483-4Report Type:Periodic Company Report #US_980707356 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa (Olanzapine) PS 15 MG/DAY 18 MON Professional Clonazepam C Date:10/30/98ISR Number: 3267486-XReport Type:Periodic Company Report #US_980707282 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Zyprexa (Olanzapine) PS 460 MG/DAY Initial or Prolonged Intentional Misuse Professional Temazepam C Nervousness Buspar C Speech Disorder Benadryl C Date:10/30/98ISR Number: 3267490-1Report Type:Periodic Company Report #US_980707193 Age:40 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anorexia Initial or Prolonged Asthenia 24-Jun-2005 12:19 PM Page: 468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Insomnia Vomiting Report Source Product Role Manufacturer Route Dose Duration Literature Zyprexa (Olanzapine) PS 10 MG/DAY 2 WK Health Professional Date:10/30/98ISR Number: 3267493-7Report Type:Periodic Company Report #US_980707173 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Study Olanzapine PS 5 MG/D DAY Life-Threatening Health Miacalcin C Professional Lasix C Aspirin C Potassium C Theodur Retard C Calcium C Date:10/30/98ISR Number: 3267497-4Report Type:Periodic Company Report #US98015059A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa (Olanzapine) PS 15 MG / 1 DAY Initial or Prolonged Diabetes Mellitus Professional Depakote C Other Diabetic Ketoacidosis Buspar C Hyperglycaemia Polyuria Sedation Stupor Tachycardia Thirst Vomiting Date:10/30/98ISR Number: 3267500-1Report Type:Periodic Company Report #US_980706878 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis A Health Zyprexa (Olanzapine) PS 1 YR Jaundice Professional Prozac (Fluoxetine Liver Function Test Hydrochloride) SS Abnormal Trazodone C Date:10/30/98ISR Number: 3267502-5Report Type:Periodic Company Report #US_980605289 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Health Zyprexa (Olanzapine) PS 7.5 MG/DAY Professional Wellbutrin C Date:10/30/98ISR Number: 3267504-9Report Type:Periodic Company Report #US_980604776 Age:20 YR Gender:Female I/FU:I Outcome PT Hospitalization - Accidental Overdose Initial or Prolonged Depression 24-Jun-2005 12:19 PM Page: 469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Injury Paranoia Report Source Product Role Manufacturer Route Dose Duration Sedation Study Olanzapine PS 20 MG/AT Health BEDTIME Professional Date:10/30/98ISR Number: 3267506-2Report Type:Periodic Company Report #US_980604555 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Psychotic Disorder Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Date:10/30/98ISR Number: 3267507-4Report Type:Periodic Company Report #US_980504164 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urinary Tract Infection Study Olanzapine PS 2.5 MG/DAY Life-Threatening Health Sinemet Cr C Hospitalization - Professional Sinemet C Initial or Prolonged Glyburide C Tylenol C Lotrisone C Dyazide C Date:10/30/98ISR Number: 3267508-6Report Type:Periodic Company Report #US_980604527 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa (Olanzapine) PS 40 MG/DAY Professional Risperdal C Navane C Vasotec C Date:10/30/98ISR Number: 3267510-4Report Type:Periodic Company Report #US_980503931 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Zyprexa (Olanzapine) PS 20 MG/DAY 1 YR Hospitalization - Phosphokinase Increased Professional Buspirone C Initial or Prolonged Coma Mirtazapine C Hypertension Hypertonia Leukocytosis Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3267512-8Report Type:Periodic Company Report #US_980503657 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 20 MG/DAY Olanzapine SS 15 MG/AT BEDTIME Motrin C Date:10/30/98ISR Number: 3267514-1Report Type:Periodic Company Report #US_980503436 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 2.5 MG/QHS Initial or Prolonged Hypoglycaemia Health DAY Hypotension Professional Allopurinol C Sedation Insulin Humulin C Glyburide C Clonidine C Fosinopril C Lasix C Albuterol C Beclomethasone Dipropionate C Motrin C Co-Trimoxazole C Date:10/30/98ISR Number: 3267516-5Report Type:Periodic Company Report #US_980502976 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Diabetic Ketoacidosis Professional Tegretol C Hyponatraemia Lamictal C Polyuria Nefedipine C Sedation Prinivil C Tachycardia Thirst Date:10/30/98ISR Number: 3267518-9Report Type:Periodic Company Report #US_980503082 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Olanzapine PS 20 MG/QD DAY Life-Threatening Health Lopid C Professional Niaspan C Ambien C Prozac C Lotensin C Amaryl C Atenolol C 24-Jun-2005 12:19 PM Page: 471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3267519-0Report Type:Periodic Company Report #US_980402030 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 18 MON Initial or Prolonged Diabetic Ketoacidosis Professional Hyperglycaemia Date:10/30/98ISR Number: 3267521-9Report Type:Periodic Company Report #US98025323A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amblyopia Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Amnesia Health Depakote C Diabetes Mellitus Professional Lithium C Diabetic Ketoacidosis Hyperglycaemia Myasthenic Syndrome Pain Paraesthesia Polyuria Renal Impairment Tremor Urinary Incontinence Vomiting Date:10/30/98ISR Number: 3267523-2Report Type:Periodic Company Report #US_980300662 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Hallucination Health Prozac C Professional Cogentin C Date:10/30/98ISR Number: 3267525-6Report Type:Periodic Company Report #US_980401276 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Neuroleptic Malignant Professional Buspar C Other Syndrome Company Remeron C Representative Date:10/30/98ISR Number: 3267527-XReport Type:Periodic Company Report #US_980401803 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Mania Health Ativan C Professional Lithium C Benadryl C 24-Jun-2005 12:19 PM Page: 472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3267529-3Report Type:Periodic Company Report #US_980401894 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Diabetic Ketoacidosis Professional Trazodone C Other Hyperglycaemia Haldol Depot C Hypotension ... C Ketoacidosis Polyuria Thirst Vomiting Date:10/30/98ISR Number: 3267531-1Report Type:Periodic Company Report #US98024669A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa (Olanzapine) PS Syndrome Professional Company Representative Date:10/30/98ISR Number: 3267532-3Report Type:Periodic Company Report #US97106763A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Zyprexa (Olanzapine) PS Initial or Prolonged Intentional Misuse Professional Prozac C Sedation Risperdal C Stupor Tachycardia Vomiting Date:10/30/98ISR Number: 3267534-7Report Type:Periodic Company Report #US97100685A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Increased Health Levothyroxine C Aspartate Professional Motrin C Aminotransferase Tylenol C Increased Blood Alkaline Phosphatase Increased Cachexia Dehydration Leukocytosis Pneumonia Date:10/30/98ISR Number: 3267536-0Report Type:Periodic Company Report #US97022308A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Literature Zyprexa (Olanzapine) PS 14 DSG FORM Initial or Prolonged Sedation Health Suicide Attempt Professional Tachycardia 24-Jun-2005 12:19 PM Page: 473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3268418-0Report Type:Periodic Company Report #US_980706868 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 1 DSG Initial or Prolonged Health FORM/DAY Professional Tenormin C Valproate Sodium C Date:10/30/98ISR Number: 3268423-4Report Type:Periodic Company Report #US_980706818 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa (Olanzapine) PS 15 MG/ 1 DAY Initial or Prolonged Anxiety Health Depression Professional Drug Ineffective Other Hostility Intentional Misuse Suicide Attempt Date:10/30/98ISR Number: 3268427-1Report Type:Periodic Company Report #US_980706442 Age:91 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 5 MG/DAY Initial or Prolonged Hostility Health Prevacid C Professional Date:10/30/98ISR Number: 3268430-1Report Type:Periodic Company Report #US_980706498 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Tachycardia Professional Thorazine C Other Date:10/30/98ISR Number: 3268435-0Report Type:Periodic Company Report #US_980706412 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 4 DAY Initial or Prolonged Paranoia Health Azmacort C Professional Zantac C Date:10/30/98ISR Number: 3268437-4Report Type:Periodic Company Report #US_980706335 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Zyprexa (Olanzapine) PS Initial or Prolonged Convulsion Professional Haldlol C Depression 24-Jun-2005 12:19 PM Page: 474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3268440-4Report Type:Periodic Company Report #US_980706351 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 15 MG/QHS AT Initial or Prolonged Health BEDTIME Professional Depakote SS 1000 MG/QHS AT BEDTIME Date:10/30/98ISR Number: 3268447-7Report Type:Periodic Company Report #US_980706302 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa (Olanzapine) PS 30MG/ 1 DAY Initial or Prolonged Depression Health Drug Ineffective Professional Hallucination Other Hostility Intentional Misuse Paranoia Date:10/30/98ISR Number: 3268451-9Report Type:Periodic Company Report #US_980706313 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS 210 MG/DAY Initial or Prolonged Sedation Professional Benztropine C Other Syncope ,,, C Date:10/30/98ISR Number: 3268456-8Report Type:Periodic Company Report #US_980706255 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoxia Study Olanzapine PS 2.5 MG/HS AT Life-Threatening Pneumonia Health BEDTIME Hospitalization - Respiratory Disorder Professional Captopril C Initial or Prolonged Deponit C Lasix C K-Dur C Lanoxin C Zoloft C Atrovent C Serevent C Remeron C Zantac C Compazine C Propulsid C Date:10/30/98ISR Number: 3268460-XReport Type:Periodic Company Report #US_980606165 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Haloperidol C Company Representative 24-Jun-2005 12:19 PM Page: 475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3268465-9Report Type:Periodic Company Report #US_980605870 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Health Zyprexa (Olanzapine) PS 10 MG/ DAY Drug Interaction Professional Phenytoin C Drug Level Above Gabapentin C Therapeutic Fluphenazine Sedation Decanoate C Date:10/30/98ISR Number: 3268470-2Report Type:Periodic Company Report #US_980605949 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Study Olanzapine PS 5 MG/ BEDTIME Hospitalization - Syncope Health DAY Initial or Prolonged Professional Haldol C Trazodone C Synthroid C Date:10/30/98ISR Number: 3268472-6Report Type:Periodic Company Report #US_980605998 Age:100 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Study Olanzapine PS Life-Threatening Health Professional Date:10/30/98ISR Number: 3268474-XReport Type:Periodic Company Report #US_980606080 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS Initial or Prolonged Depression Health Placebo SS Hallucination Professional Olanzapine C Paranoia Hematocrit C Lymphocytes C Creatinine C Wbc Count C Erythrocyte C Ua-Ketones C Ua-Occult Blood C Cpk C X-Ray/Normal C Date:10/30/98ISR Number: 3268478-7Report Type:Periodic Company Report #US_980606081 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Intentional Misuse Health Prozac (Fluoxetine Professional Hydrochloride) SS 1 WK Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3268482-9Report Type:Periodic Company Report #US_980605665 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Olanzapine PS 7.5 MG/ D DAY Initial or Prolonged Cardiac Failure Health Lasix C Congestive Professional Vasotec C Toprol C Potassium Chloride C Synthroid C Multivitamin C Lactulose C Acetylsalicylic Acid C Lortab C Date:10/30/98ISR Number: 3268486-6Report Type:Periodic Company Report #US_980604858 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa (Olanzapine) PS 10 MG/ AT Initial or Prolonged Apathy Other BEDTIME Epistaxis Phenylpropanolamine Hallucination W/Guaifenesin C Hostility Tessalon Perle C Influenza Like Illness Septra Ds C Muscle Twitching Personality Disorder Tinnitus Weight Increased Date:10/30/98ISR Number: 3268493-3Report Type:Periodic Company Report #US_980604978 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS 15 MG/DAY 4 MON Phosphokinase Increased Professional Tegretol Coma (Carbamazepine) C Neuroleptic Malignant Lisinopril C Syndrome Hytrin C Pyrexia Atenolol C Tachycardia Mysoline C Benadryl C Albuterol C Date:10/30/98ISR Number: 3268500-8Report Type:Periodic Company Report #US_980605171 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Olanzapine PS 10 MG/D DAY Health Zyprexa C Professional Verapamil C Micronase C Depakote C Therapeutic Multivitamins C Ferrous Sulfate C 24-Jun-2005 12:19 PM Page: 477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/98ISR Number: 3151520-1Report Type:Expedited (15-DaCompany Report #US_981011829 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Zyprexa PS 2.5 MG/1 DAY Hospitalization - Abdominal Pain Professional Haldol C Initial or Prolonged Blood Culture Positive Proscar C Cardiac Arrest Lasix C Gastrointestinal K-Dur C Haemorrhage Darvon C Oliguria Augmentin C Pain Sepsis Date:11/03/98ISR Number: 3151521-3Report Type:Expedited (15-DaCompany Report #GBS981001705 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Mania Health Ranitidine C Professional Chlorpromazine C Date:11/03/98ISR Number: 3151523-7Report Type:Expedited (15-DaCompany Report #US_981011837 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Foreign Zyprexa PS 2.5 MG/1 DAY 2 WK Initial or Prolonged Health Sinemet C Professional Other Date:11/03/98ISR Number: 3151525-0Report Type:Expedited (15-DaCompany Report #GBS981001695 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Abortion Spontaneous Consumer Dothiepin C Vaginal Haemorrhage Health Mebeverine C Professional Thioridazine C Other Date:11/03/98ISR Number: 3151527-4Report Type:Expedited (15-DaCompany Report #EWC980901529 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 5 MG/DAY Injury Asphyxiation Health Lysanxia C Professional Lepticur C Company Representative Other 24-Jun-2005 12:19 PM Page: 478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/98ISR Number: 3151529-8Report Type:Expedited (15-DaCompany Report #GBS980600847 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS Initial or Prolonged Overdose Health Respiratory Distress Professional Suicide Attempt Company Urinary Retention Representative Other Date:11/03/98ISR Number: 3151531-6Report Type:Expedited (15-DaCompany Report #DE_981000478 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Zyprexa PS 10 MG/ 1 DAY 8 WK Initial or Prolonged Health Madopar C Professional Other Date:11/03/98ISR Number: 3152536-1Report Type:Expedited (15-DaCompany Report #DE_980700208 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 20 MG DAY Initial or Prolonged Health Didronel C Professional Date:11/03/98ISR Number: 3152538-5Report Type:Expedited (15-DaCompany Report #EWC981001849 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS 5 MG/DAY 3 WK Hospitalization - Completed Suicide Health Haldol C Initial or Prolonged Convulsion Professional Temesta C Intentional Misuse Depakine C Date:11/03/98ISR Number: 3152588-9Report Type:Expedited (15-DaCompany Report #GBS981001743 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa (Olanzapine) PS UNKNOWN UNKNOWN Abortion Spontaneous Health Dothiepin C Vaginal Haemorrhage Professional Mebeverine C Thioridazine C Date:11/03/98ISR Number: 3152590-7Report Type:Expedited (15-DaCompany Report #AU_981000320 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa (Olanzapine) PS UNKNOWN UNKNOWN Exposure To Therapeutic Health Drugs Professional Multiple Congenital Abnormalities Premature Baby 24-Jun-2005 12:19 PM Page: 479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/98ISR Number: 3152592-0Report Type:Expedited (15-DaCompany Report #GBS980701056 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Foreign Zyprexa (Olanzapine) PS UNKNOWN 15MG/1 DAY Hospitalization - Chronic Obstructive Health UNKNOWN Initial or Prolonged Pulmonary Disease Professional Salbutamol C Coma Company Prednisolone C Cyanosis Representative Moduretic C Dyspnoea Exacerbated Ipratropium C Lower Respiratory Tract Co-Amoxiclav C Infection Procyclidine C Pyrexia Quinine Sulphate C Respiratory Failure Aminophylline C Sedation Lactulose C Kalms C Bromide C Date:11/03/98ISR Number: 3152594-4Report Type:Expedited (15-DaCompany Report #US_981012018 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arterial Rupture Health Zyprexa (Olanzapine) PS UNKNOWN 20 MG/1 DAY Hospitalization - Coma Professional UNKNOWN Initial or Prolonged Haemorrhage Intracranial Depakote (Valproate Thrombocytopenia Semisodium) C Folic Acid C Azmacort (Triamcinolone Acetonide) C Singulair (Montelukast) C Haldol (Haloperidol) C Date:11/03/98ISR Number: 3152596-8Report Type:Expedited (15-DaCompany Report #EWC981001790 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS UNKNOWN 5 MG/DAY Health UNKNOWN Professional Piportil (Pipotiazine) C Date:11/03/98ISR Number: 3152621-4Report Type:Expedited (15-DaCompany Report #US 981012124 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa PS Syndrome Professional Meridia C Date:11/03/98ISR Number: 3152622-6Report Type:Expedited (15-DaCompany Report #US 980809346 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Zyprexa PS 5MG/1 AT Initial or Prolonged Drug Toxicity Professional BEDTIME Salivary Hypersecretion Gabapentin C Weight Increased 24-Jun-2005 12:19 PM Page: 480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/98ISR Number: 3152625-1Report Type:Expedited (15-DaCompany Report #US 981012209 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Zyprexa PS Professional Lorazepam C Sertraline C Date:11/03/98ISR Number: 3152626-3Report Type:Expedited (15-DaCompany Report #US 981012271 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ketoacidosis Health Zyprexa PS Professional Date:11/03/98ISR Number: 3152628-7Report Type:Expedited (15-DaCompany Report #US 981012246 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS 5MG 1 DAY 10 DAY Initial or Prolonged Mania Professional Haldol C Pressure Of Speech Valproate Bismuth C Psychotic Disorder Inderal C Restlessness Hydrochlorothiazide C Sleep Disorder Darvocrt-N C Date:11/03/98ISR Number: 3152630-5Report Type:Expedited (15-DaCompany Report #US 981012207 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Zyprexa PS Professional Date:11/04/98ISR Number: 3151832-1Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Olanzapine PS ORAL 2.5 MG AM, Dysphemia 7.5 MG PM Digoxin C 0.125 MG PO QD Hydralazine C ORAL 100 MG PO Q8 Nephrocaps C 1 QD Phos C Imdur C 60 MG QD Cardura C 2 MG QD Ativan C 0.5 MG HS PRN Zoloft C 25 MG QAM Date:11/09/98ISR Number: 3154395-XReport Type:Expedited (15-DaCompany Report #SE97075716A Age:61 YR Gender:Male I/FU:F Outcome PT Disability Asthenia Other Confusional State Erectile Dysfunction Hallucination 24-Jun-2005 12:19 PM Page: 481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Impairment Priapism Suspiciousness Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS 10 MG/1 DAY Health Stesolid C Professional Lactulose C Madopark Other Ostanorm C Sinemet - Slow Release C Madopark Quick Mite C Date:11/09/98ISR Number: 3154438-3Report Type:Expedited (15-DaCompany Report #GBS981001705 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Mania Health Ranitidine C Professional Other Date:11/09/98ISR Number: 3154441-3Report Type:Expedited (15-DaCompany Report #AU_981000320 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acquired Foreign Zyprexa (Olanzapine) PS UNK Initial or Prolonged Tracheo-Oesophageal Health Congenital Anomaly Fistula Professional Complications Of Maternal Exposure To Therapeutic Drugs Congenital Anomaly Oesophageal Atresia Date:11/09/98ISR Number: 3154443-7Report Type:Expedited (15-DaCompany Report #US_981011691 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa (Olanzapine) PS 5 MG/1 DAY Confusional State Zoloft (Sertraline Dizziness Hydrochloride) C Lethargy Depakote (Valproate Psychotic Disorder Semisodium) C Date:11/09/98ISR Number: 3154525-XReport Type:Expedited (15-DaCompany Report #EWC981001884 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ectopic Pregnancy Foreign Zyprexa PS Health Professional 24-Jun-2005 12:19 PM Page: 482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/98ISR Number: 3154527-3Report Type:Expedited (15-DaCompany Report #EWC981101901 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Zyprexa PS 10 MG/DAY Haemorrhagic Stroke Health Rivotril C Skull Fracture Professional Dormicum C Company Representative Date:11/09/98ISR Number: 3154528-5Report Type:Expedited (15-DaCompany Report #EWC981001856 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphonia Foreign Zyprexa PS 15 MG/DAY Dystonia Health Deroxat C Leukopenia Professional Largactil C Torticollis Date:11/09/98ISR Number: 3154529-7Report Type:Expedited (15-DaCompany Report #EWC981001868 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Foreign Zyprexa PS 17.5 MG/DAY Confusional State Health Eltroxin C Fall Professional Grand Mal Convulsion Muscle Rigidity Tremor Date:11/09/98ISR Number: 3154530-3Report Type:Expedited (15-DaCompany Report #DE_981000521 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Foreign Zyprexa PS 10 MG/DAY 2 WK Initial or Prolonged Hypoglycaemia Health Carbamazepine C Leukocytosis Professional Furosemide C Pneumonia Nepresol C Pyrexia Euthyrox C Tremor Adalat C Ferro Sanol C Date:11/09/98ISR Number: 3154539-XReport Type:Expedited (15-DaCompany Report #CA_981000206 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Zyprexa PS Health Professional Date:11/09/98ISR Number: 3154541-8Report Type:Expedited (15-DaCompany Report #EWC980901577 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parosmia Foreign Zyprexa PS 15 MG/DAY Health Tranxene C Professional 24-Jun-2005 12:19 PM Page: 483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/98ISR Number: 3154627-8Report Type:Expedited (15-DaCompany Report #US_981012355 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS 10 MG/1 DAY 5 WK Initial or Prolonged Blood Creatine Professional Prozac SS 40 MG DAY 5 WK Other Phosphokinase Increased Blood Glucose Increased Coma Convulsion Dehydration Depressed Level Of Consciousness Diabetic Ketoacidosis Drug Ineffective Electroencephalogram Abnormal Fall Heart Rate Increased Hyperphagia Hyperpyrexia Joint Stiffness Meningitis Muscle Rigidity Neuroleptic Malignant Syndrome Pneumonia Aspiration Polyuria Sedation Temperature Regulation Disorder Thinking Abnormal Thirst Date:11/09/98ISR Number: 3154631-XReport Type:Expedited (15-DaCompany Report #US_981012635 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Consumer Zyprexa PS 5 MG/ 1 DAY Consciousness Prozac SS 20 MG/ 2 DAY Dysarthria Elavil C Hallucination, Visual Xanax C Overdose Pulse Absent Weight Increased Date:11/09/98ISR Number: 3154634-5Report Type:Expedited (15-DaCompany Report #US_980910486 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa PS 5 MG/DAY 2 WK Initial or Prolonged Congestive Professional Naproxen C Crepitations Valproic Acid C Dyspnoea Oedema Peripheral Weight Increased 24-Jun-2005 12:19 PM Page: 484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/98ISR Number: 3154638-2Report Type:Expedited (15-DaCompany Report #US_981012277 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa PS Leukopenia Professional Prozac C Neutropenia Other Cogentin C Klonopin C Date:11/09/98ISR Number: 3154749-1Report Type:Expedited (15-DaCompany Report #98D-10966 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Anafranil PS 150 MG, DAILY Initial or Prolonged Cold Sweat Health Zyprexa SS Heart Rate Increased Professional Hyperreflexia Hypertension Serotonin Syndrome Tremor Date:11/10/98ISR Number: 3154465-6Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Olanzapine PS 5 MG HS, 10 MG HS Date:11/11/98ISR Number: 3155314-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Olanzapine PS 10 MG QHS Date:11/12/98ISR Number: 3156633-6Report Type:Expedited (15-DaCompany Report #AU_981000332 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Foreign Zyprexa PS 20 MG/DAY Initial or Prolonged Anxiety Health Condition Aggravated Professional Medication Error Panic Attack Psychotic Disorder Date:11/13/98ISR Number: 3157843-4Report Type:Direct Company Report # Age:77 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacteriuria Zyprexa PS ORAL 5MG PO QD Initial or Prolonged Blood Chloride Decreased Haematuria Hyponatraemia Proteinuria Water Intoxication White Blood Cells Urine Positive 24-Jun-2005 12:19 PM Page: 485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/98ISR Number: 3157767-2Report Type:Expedited (15-DaCompany Report #EWC981001688 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Foreign Zyprexa PS 10 MG/DAY Hospitalization - Bronchopneumonia Health Madopar C Initial or Prolonged Cardiac Arrest Professional Parolodel C Other Electrocardiogram Qt Other Effortil C Prolonged Loss Of Consciousness Myocardial Infarction Ventricular Fibrillation Date:11/16/98ISR Number: 3157832-XReport Type:Expedited (15-DaCompany Report #EWC981101919 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zyprexa PS 5 MG/DAY Complications Of Maternal Health Exposure To Therapeutic Professional Drugs Company Representative Date:11/16/98ISR Number: 3157835-5Report Type:Expedited (15-DaCompany Report #GBS980600676 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS 10 MG DAY 3 WK Cardiac Arrest Health Paroxetine C Circulatory Collapse Professional Thioridazine C Drug Interaction Company Diazepam C Drug Toxicity Representative Benztropine C Date:11/16/98ISR Number: 3157844-6Report Type:Expedited (15-DaCompany Report #GBS981101827 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Zyprexa PS UNKNOWN 2.5 MG DAY Dystonia Health UNKNOWN Muscle Rigidity Professional Temazepam C Other Paroxetine C Date:11/16/98ISR Number: 3157892-6Report Type:Direct Company Report # Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Olanzapine 5 Mg PS ORAL 5MG PO HS Sedation Date:11/16/98ISR Number: 3158010-0Report Type:Expedited (15-DaCompany Report #US_981012635 Age:39 YR Gender:Male I/FU:F Outcome PT Other Cardiac Arrest Depressed Level Of Consciousness Hallucination, Visual 24-Jun-2005 12:19 PM Page: 486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Speech Disorder Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa PS 5 MG/1 DAY Prozac SS 20 MG/2 DAY Elavil C Xanax C Date:11/16/98ISR Number: 3158023-9Report Type:Expedited (15-DaCompany Report #GBS981101851 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa PS 40 MG Initial or Prolonged Health Chlorpromazine C Professional Date:11/16/98ISR Number: 3158025-2Report Type:Expedited (15-DaCompany Report #AU_981100341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Intentional Misuse Health Professional Date:11/16/98ISR Number: 3158027-6Report Type:Expedited (15-DaCompany Report #CA_981100218 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Foreign Zyprexa PS Mesenteric Occlusion Health Professional Company Representative Date:11/16/98ISR Number: 3158040-9Report Type:Expedited (15-DaCompany Report #US_980910580 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Zyprexa (Olanzapine) PS Professional Effexor C Klonopin C Oral Contraceptive Nos C Levoxyl (Levothyroxine Sodium) C Mellaril (Thioridazine Hydrochloride) C Date:11/16/98ISR Number: 3158041-0Report Type:Expedited (15-DaCompany Report #GBS980700955 Age:22 YR Gender:Female I/FU:F Outcome Death Life-Threatening 24-Jun-2005 12:19 PM Page: 487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hospitalization - Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Brain Hypoxia Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY Brain Oedema Health Paracetamol C Cardiac Arrest Professional Ferrous Sulphate C Cardiac Failure Other Trifluoperazine C Cardio-Respiratory Arrest Procyclidine C Circulatory Collapse Stemetil Convulsion (Prochlorperazine) C Drug Level Above Stelazine Therapeutic (Trifluoperazine Drug Level Below Hydrochloride) C Therapeutic Drug Toxicity Electrocardiogram Qt Prolonged Electroencephalogram Abnormal Headache Hepatic Function Abnormal Neurological Examination Abnormal Overdose Pneumonia Pupil Fixed Pyrexia Renal Impairment Date:11/16/98ISR Number: 3158043-4Report Type:Expedited (15-DaCompany Report #US_980910808 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Health Zyprexa (Olanzapine) PS 20 MG/1 DAY 3 MON Hospitalization - Abdominal Pain Professional Paxil C Initial or Prolonged Coma Diabetes Mellitus Hyperglycaemia Joint Stiffness Multi-Organ Failure Muscle Rigidity Pyrexia Date:11/16/98ISR Number: 3158045-8Report Type:Expedited (15-DaCompany Report #US_981011415 Age:34 YR Gender:Female I/FU:F Outcome PT Other Acne Breast Mass Breast Pain Calcinosis Depression Fibrocystic Breast Disease Flushing Headache Hyperplasia Menstruation Irregular Mood Swings 24-Jun-2005 12:19 PM Page: 488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Night Sweats Premature Menopause Premenstrual Syndrome Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa (Olanzapine) PS 10 MG/1 DAY Health Klonopin Professional (Clonazepam) C Date:11/16/98ISR Number: 3158047-1Report Type:Expedited (15-DaCompany Report #US_981012277 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa (Olanzapine) PS Dystonia Professional Prozac C Full Blood Count Other Cogentin C Decreased Klonopin C Neutrophil Count Decreased Pruritus Date:11/16/98ISR Number: 3158051-3Report Type:Expedited (15-DaCompany Report #US_981012355 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 5 WK Initial or Prolonged Blood Creatine Professional Prozac (Fluoxetine Other Phosphokinase Increased Hydrochloride) SS 40 MG DAY 5 WK Coma Dehydration Depressed Level Of Consciousness Diabetic Ketoacidosis Drug Ineffective Electroencephalogram Abnormal Fall Hyperglycaemia Joint Stiffness Meningitis Muscle Rigidity Neuroleptic Malignant Syndrome Pneumonia Aspiration Polyuria Pyrexia Simple Partial Seizures Temperature Regulation Disorder Thinking Abnormal Thirst Date:11/16/98ISR Number: 3158058-6Report Type:Expedited (15-DaCompany Report #US_981112856 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Health Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Professional Prozac SS 40 MG/1 DAY 24-Jun-2005 12:19 PM Page: 489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/98ISR Number: 3158060-4Report Type:Expedited (15-DaCompany Report #US_981112712 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Depakote C Wellbutrin C Date:11/16/98ISR Number: 3158062-8Report Type:Expedited (15-DaCompany Report #US_981112701 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Health Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Circulatory Collapse Professional Ativan C Initial or Prolonged Hyponatraemia Loss Of Consciousness Date:11/16/98ISR Number: 3158063-XReport Type:Expedited (15-DaCompany Report #US_981011746 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Hospitalization - Circulatory Collapse Professional Ativan C Initial or Prolonged Hyponatraemia Loss Of Consciousness Respiratory Arrest Date:11/16/98ISR Number: 3158169-5Report Type:Expedited (15-DaCompany Report #GBS980500603 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa PS Cardiac Arrest Consumer Depixol C Cardiomegaly Health Circulatory Collapse Professional Cyanosis Company Drug Ineffective Representative Faecal Incontinence Other Fall Gait Disturbance Head Injury Injury Intentional Self-Injury Malaise Obstructive Airways Disorder Pulse Absent Stress Thinking Abnormal Tongue Oedema Viral Myocarditis Date:11/16/98ISR Number: 3158171-3Report Type:Expedited (15-DaCompany Report #US 980707769 Age:37 YR Gender:Male I/FU:F Outcome PT Disability Eye Haemorrhage Other Maculopathy 24-Jun-2005 12:19 PM Page: 490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 20MG/DAY 545 DAY Professional Cocaine C Company Cogentin C Representative Wellbutrin Sr C Date:11/16/98ISR Number: 3158196-8Report Type:Expedited (15-DaCompany Report #DE_ 981100566 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Health Anafranil Professional (Clomipramine Hydrochloride) C Dociton (Propranolol Hydrochloride) C Date:11/16/98ISR Number: 3158258-5Report Type:Expedited (15-DaCompany Report #DE_981100565 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Zyprexa PS 10 MG Initial or Prolonged Delirium Health Stangyl C Grand Mal Convulsion Professional Oxazepam C Inappropriate Gastrozepin C Antidiuretic Hormone Vomex C Secretion Renal Failure Restlessness Date:11/16/98ISR Number: 3158260-3Report Type:Expedited (15-DaCompany Report #CA_981100226 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Overdose Health Professional Company Representative Date:11/16/98ISR Number: 3158262-7Report Type:Expedited (15-DaCompany Report #EWC980300144 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ewing'S Sarcoma Foreign Zyprexa PS 10 MG/DAY Pyrexia Health Lorazepam C Professional Diazepam C Naproxen C Paracetamol C 24-Jun-2005 12:19 PM Page: 491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/98ISR Number: 3158277-9Report Type:Expedited (15-DaCompany Report #DE_981100572 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prothrombin Time Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Prolonged Health Remergil C Professional Marcumar C Sotalex C Ovestin C Date:11/16/98ISR Number: 3158280-9Report Type:Expedited (15-DaCompany Report #DE_981100568 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 5 MG / DAY Initial or Prolonged Health Fluanxol C Professional Date:11/17/98ISR Number: 3159180-0Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Olanzapine PS ORAL 5MG QD ORAL Dizziness Gemfibrozil C Headache Colestipol Hcl C Vomiting Multivitamin C Pyridoxine Hcl C Thiamine Hcl C Lansoprazole C Burpropion Hcl C Buspirone Hcl C Flurazepam (Dalmane) C Carisoprodol C Date:11/19/98ISR Number: 3159484-1Report Type:Expedited (15-DaCompany Report #8-98315-001A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Foreign Stangyl Capsules Initial or Prolonged Health (Trimipramine Other Professional Maleate) PS ORAL ORAL 150MG/225MG/2 00MG/100MG/50 MG/25 50 DAY Olanzapine Tablets SS ORAL 5 MG, THEN INCREASED TO 10 MG, THEN DECREASED TO 5 MG DAILY Lorazepam C Date:11/19/98ISR Number: 3160533-5Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Other Feeling Abnormal Hyperhidrosis Hypermetabolism 24-Jun-2005 12:19 PM Page: 492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Palpitations Respiratory Rate Increased Report Source Product Role Manufacturer Route Dose Duration Sleep Disorder Health Zyprexia PS Lily ORAL 5 MG QHS PRN Tremor Professional PO Date:11/19/98ISR Number: 3160636-5Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Olanzapine PS Novartis Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/98ISR Number: 3161526-4Report Type:Expedited (15-DaCompany Report #7397339 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Depakene Syrup PS Abbott Initial or Prolonged Drug Level Below Professional Olanzapine SS QD Therapeutic Calcium Carbonate C Acetaminophen C Albuterol C Bisacodyl C Ipratropium C Lorazepam C Magnesium Hyrdoxide C Date:11/23/98ISR Number: 3161619-1Report Type:Expedited (15-DaCompany Report #DE_981100568 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa PS 5 MG/DAY Initial or Prolonged Health Fluanxol C Professional Date:11/23/98ISR Number: 3161676-2Report Type:Expedited (15-DaCompany Report #GBS981101935 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grandiosity Foreign Zyprexa PS 10MG DAY Initial or Prolonged Health Professional Other Date:11/23/98ISR Number: 3161677-4Report Type:Expedited (15-DaCompany Report #EWC98110199 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 5MG/DAY Initial or Prolonged Nasopharyngitis Health Procef C Pyrexia Professional Ornade C Other 24-Jun-2005 12:19 PM Page: 493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/98ISR Number: 3161678-6Report Type:Expedited (15-DaCompany Report #AU_981100353 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Zyprexa PS 10MG/DAY Initial or Prolonged Decreased Health Bradycardia Professional Orthostatic Hypotension Other Date:11/23/98ISR Number: 3161680-4Report Type:Expedited (15-DaCompany Report #US_981113199 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Consumer Zyprexa PS Other Cerebrovascular Accident Convulsion Date:11/23/98ISR Number: 3161681-6Report Type:Expedited (15-DaCompany Report #CA_981000206 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Zyprexa PS 25MG Hospitalization - Myocardial Infarction Health Spironolactone C Initial or Prolonged Professional Oral Antidiabetics C Other Oral Antihypertensive C Date:11/23/98ISR Number: 3161754-8Report Type:Expedited (15-DaCompany Report #CA-981100218 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Foreign Zyprexa PS 2.5 MG/2 DAY Mesenteric Occlusion Health Professional Company Representative Date:11/23/98ISR Number: 3161756-1Report Type:Expedited (15-DaCompany Report #CA_981100226 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 1 DSG FORM/1 Intentional Misuse Health DAY Professional Company Representative Date:11/23/98ISR Number: 3161761-5Report Type:Expedited (15-DaCompany Report #GBS981001743 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa PS Abortion Spontaneous Health Dothiepin C Complications Of Maternal Professional Exposure To Therapeutic Other Drugs Vaginal Haemorrhage 24-Jun-2005 12:19 PM Page: 494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3162156-0Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Zyprexa PS Eli Lilly ORAL 10MG PO HS Weight Increased Prozac C Seroquel C Date:11/30/98ISR Number: 3163980-0Report Type:Expedited (15-DaCompany Report #AU_981100352 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Foreign Zyprexa PS 10 MG/1 IN Initial or Prolonged Pancreatitis Health THE EVENING Professional Valproate Sodium C Lithium C Date:11/30/98ISR Number: 3163983-6Report Type:Expedited (15-DaCompany Report #EWC981102041 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS 10 MG/DAY Weight Decreased Health Fluoxetine SS 20 MG/DAY Professional Date:11/30/98ISR Number: 3163985-XReport Type:Expedited (15-DaCompany Report #GBS981001802 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Transient Foreign Zyprexa PS 10 MG DAY Health Professional Date:11/30/98ISR Number: 3163995-2Report Type:Expedited (15-DaCompany Report #US_980300658 Age:67 YR Gender:Male I/FU:I Outcome PT Death Abdominal Pain Hospitalization - Agitation Initial or Prolonged Ammonia Increased Other Anxiety Blood Creatine Phosphokinase Increased Blood Culture Positive Blood Lactate Dehydrogenase Increased Blood Pressure Increased Blood Sodium Increased Body Temperature Increased Cholelithiasis Colorectal Cancer Confusional State Dehydration Delirium Depressed Level Of Consciousness Diarrhoea 24-Jun-2005 12:19 PM Page: 495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Below Therapeutic Dyskinesia Report Source Product Role Manufacturer Route Dose Duration Echolalia Literature Olanzapine PS 10 MG/DAY Heart Rate Increased Health Valproic Acid C Hyperhidrosis Professional Lorazepam C Hypernatraemia Other Folate Sodium C Ileus Paralytic Thiamine C Intestinal Dilatation Docusate Sodium C Intestinal Functional Disorder Mania Metastases To Liver Miosis Muscle Rigidity Mydriasis Nausea Neuroleptic Malignant Syndrome Pyrexia Sedation Tremor Urinary Incontinence Vomiting Date:11/30/98ISR Number: 3163999-XReport Type:Expedited (15-DaCompany Report #US_981112856 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS 5 MG/2 DAY Initial or Prolonged Blood Creatinine Professional Prozac (Fluoxetine Increased Hydrochloride) SS 40 MG/1 DAY Blood Osmolarity Tenoretic C Increased Blood Urea Increased Coma Cushing'S Syndrome Dehydration Diabetic Hyperosmolar Coma Dysarthria Glucose Urine Glycosylated Haemoglobin Increased Hypercapnia Hyperglycaemia Hypernatraemia Oliguria Polydipsia Polyuria Proteinuria Renal Failure Acute Renal Impairment Respiratory Acidosis Respiratory Distress Sinusitis 24-Jun-2005 12:19 PM Page: 496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/98ISR Number: 3164002-8Report Type:Expedited (15-DaCompany Report #DE_981100623 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Zyprexa PS Initial or Prolonged Decreased Health Professional Date:11/30/98ISR Number: 3164003-XReport Type:Expedited (15-DaCompany Report #DE_981100644 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Hypersensitivity Health Pruritus Professional Other Date:11/30/98ISR Number: 3164006-5Report Type:Expedited (15-DaCompany Report #EWC981102094 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Intentional Misuse Health Laroxyl C Professional Tranxene C Company Representative Date:11/30/98ISR Number: 3164008-9Report Type:Expedited (15-DaCompany Report #US_981113370 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Date:11/30/98ISR Number: 3164020-XReport Type:Expedited (15-DaCompany Report #US-981113409 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Consumer Zyprexa PS 5 MG/1 DAY 1 WK Initial or Prolonged Difficulty In Walking Effexor C Dysuria Oedema Genital Date:11/30/98ISR Number: 3164030-2Report Type:Expedited (15-DaCompany Report #AU-981100355 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa PS 10 MG/ 1 DAY Bile Duct Obstruction Health Aropax C Blood Creatine Increased Professional Zantac C Blood Urea Increased Serepax C Cholelithiasis Neo-Cytamen C Condition Aggravated Resonium A C Gallbladder Obstruction Jaundice Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/98ISR Number: 3164036-3Report Type:Expedited (15-DaCompany Report #GBS981101976 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Tachycardia Foreign Zyprexa PS Initial or Prolonged Health Professional Company Representative Date:11/30/98ISR Number: 3164038-7Report Type:Expedited (15-DaCompany Report #EWC980901479 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Foreign Zyprexa PS 10 MG/DAY 2 DAY Hospitalization - Cardio-Respiratory Arrest Health Leponex C Initial or Prolonged Coma Professional Depakine C Convulsion Tranxene C Date:11/30/98ISR Number: 3164076-4Report Type:Expedited (15-DaCompany Report #DE_981100631 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Venous Thrombosis Limb Foreign Zyprexa PS 15 MG DAY Initial or Prolonged Health Contraceptive Drug C Professional Other Date:11/30/98ISR Number: 3164178-2Report Type:Expedited (15-DaCompany Report #GBS981101976 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS 15 MG/1 DAY Initial or Prolonged Ventricular Tachycardia Health Depixol C Professional Company Representative Other Date:11/30/98ISR Number: 3164217-9Report Type:Expedited (15-DaCompany Report #105506 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Other Klonopin PS ORAL 1 MG 4 X PRN Initial or Prolonged Photopsia ORAL Vision Blurred Zyprexa SS ORAL ORAL Weight Decreased Date:12/01/98ISR Number: 3163962-9Report Type:Expedited (15-DaCompany Report #EWC981001688 Age:78 YR Gender:Female I/FU:F Outcome PT Death Brain Hypoxia Hospitalization - Bronchopneumonia Initial or Prolonged Cardiac Arrest Other Electrocardiogram Qt Prolonged 24-Jun-2005 12:19 PM Page: 498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocardial Infarction Ventricular Fibrillation Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS 10 MG/DAY Health Madopar C Professional Parlodel Other (Bromocriptine Mesilate) C Effortil (Etilefrine Hydrochloride) C Cohemin Depot (Hydroxocobalamin Acetate) C Date:12/01/98ISR Number: 3163965-4Report Type:Expedited (15-DaCompany Report #DE_980700205 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa PS 20 MG/1 DAY Initial or Prolonged Hepatitis Cholestatic Health Minisiston Hepatomegaly Professional Contraception C Jaundice Other Tavor (Lorazepam) C Pruritus Date:12/01/98ISR Number: 3163968-XReport Type:Expedited (15-DaCompany Report #EWC981101919 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zyprexa PS 5 MG/EVERY Health OTHER DAY Professional Levothyrox C Company Representative Date:12/01/98ISR Number: 3163971-XReport Type:Expedited (15-DaCompany Report #EWC981001884 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ectopic Pregnancy Foreign Zyprexa PS Initial or Prolonged Health Xanax C Professional Date:12/01/98ISR Number: 3163975-7Report Type:Expedited (15-DaCompany Report #AU_981000332 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Foreign Zyprexa PS 20 MG/IN THE Initial or Prolonged Anxiety Health EVENING Extrapyramidal Disorder Professional Medication Error Panic Attack 24-Jun-2005 12:19 PM Page: 499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/98ISR Number: 3163978-2Report Type:Expedited (15-DaCompany Report #US_981012124 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Zyprexa PS Other Phosphokinase Increased Meridia (Sibutramine Circulatory Collapse Hydrochloride) C Neuroleptic Malignant Syndrome Pyrexia Date:12/01/98ISR Number: 3163982-4Report Type:Expedited (15-DaCompany Report #EWC980701089 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa PS 15 MG DAY Life-Threatening Hypovolaemic Shock Health Voltarene Hospitalization - Intestinal Obstruction Professional (Diclofenac Sodium) C Initial or Prolonged Vomiting Date:12/01/98ISR Number: 3163986-1Report Type:Expedited (15-DaCompany Report #CA_981100226 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 1 DSG FORM/1 Intentional Misuse Health DAY Professional Company Representative Date:12/07/98ISR Number: 3168254-XReport Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Olanzapine PS ORAL 20 MG/ QHS / Dyskinesia PO Dystonia Lorazepam C Musculoskeletal Stiffness Date:12/07/98ISR Number: 3168261-7Report Type:Direct Company Report # Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Olanzapine PS ORAL 10 MG / QHS / PO Valproic Acid C Date:12/08/98ISR Number: 3167930-2Report Type:Expedited (15-DaCompany Report #9839924 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Drug Effect Decreased Initial or Prolonged Drug Ineffective Required Hallucination Intervention to Sedation Prevent Permanent Social Avoidant Behaviour Impairment/Damage Suicide Attempt 24-Jun-2005 12:19 PM Page: 500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Consumer Navane PS ORAL ORAL Olanzapine SS ORAL ORAL Risperidone SS ORAL ORAL Prozac SS ORAL ORAL Cogentin C Date:12/08/98ISR Number: 3168551-8Report Type:Expedited (15-DaCompany Report #DE_981100623 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 20 MG Health Professional Date:12/08/98ISR Number: 3168553-1Report Type:Expedited (15-DaCompany Report #GBS980701074 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Zyprexa (Olanzapine) PS Coronary Artery Disease Consumer Procyclidine C Delusion Of Reference Health Depression Professional Drug Toxicity Extrapyramidal Disorder Haemorrhage Hypertrophy Overdose Persecutory Delusion Psychotic Disorder Tremor Date:12/08/98ISR Number: 3168607-XReport Type:Expedited (15-DaCompany Report #CA_981100253 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa PS 15 MG/1DAY Initial or Prolonged Grandiosity Health Flurazepam C Hallucination Professional Metoprolol C Paranoia Other Psychotic Disorder Date:12/08/98ISR Number: 3168609-3Report Type:Expedited (15-DaCompany Report #GBS981102057 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS 2.5 MG/2 DAY Initial or Prolonged Complete Health Omeprazole C Professional Procyclidine C Frusemide C 24-Jun-2005 12:19 PM Page: 501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/98ISR Number: 3168652-4Report Type:Expedited (15-DaCompany Report #GBS981001802 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Foreign Zyprexa (Olanzapine) PS 10 MG DAY Health Professional Date:12/08/98ISR Number: 3168653-6Report Type:Expedited (15-DaCompany Report #GBS980801318 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa PS Completed Suicide Consumer Condition Aggravated Health Medication Error Professional Schizophrenia, Paranoid Other Type Therapeutic Agent Toxicity Date:12/08/98ISR Number: 3168718-9Report Type:Expedited (15-DaCompany Report #EWC981102144 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zyprexa PS Thrombosis Health Professional Date:12/09/98ISR Number: 3168466-5Report Type:Expedited (15-DaCompany Report #GBS981101976 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS 15 MG/ 1 DAY Initial or Prolonged Ventricular Tachycardia Health Depixol C Professional Company Representative Date:12/09/98ISR Number: 3168467-7Report Type:Expedited (15-DaCompany Report #US_981011209 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa PS Professional Clonazepam C Alcohol C Date:12/09/98ISR Number: 3169481-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Zyprexa PS ORAL 15MG PO QHS; Initial or Prolonged Haemoglobin Decreased 5MG NG QHS Other Leukopenia Pancytopenia 24-Jun-2005 12:19 PM Page: 502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/98ISR Number: 3169701-XReport Type:Expedited (15-DaCompany Report #7397339 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Depakene PS Abbott SYRUP Initial or Prolonged Drug Level Below Professional Olanzapine SS QD Therapeutic Olanzapine C Pneumonia Calcium Carbonate C Acetaminophen C Albuterol C Bisacodyl C Ipratropium C Lorazepam C Magnesium Hydrochloride C Date:12/11/98ISR Number: 3178001-3Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Olanzapine PS ORAL 15MG Q HS PO Depakote C Date:12/14/98ISR Number: 3170032-2Report Type:Expedited (15-DaCompany Report #US_980809280 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Zyprexa (Olanzapine) PS 5 MG/1 DAY 1 WK Professional Clozaril C Lithium C Serzone C Cogentin C Date:12/14/98ISR Number: 3170209-6Report Type:Expedited (15-DaCompany Report #CA_980900158 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa PS 2.5 MG Initial or Prolonged Pancreatitis Acute Health Luvox C White Blood Cell Count Professional Tylenol With Codeine C Increased Other Ibuprofen C Date:12/14/98ISR Number: 3170263-1Report Type:Expedited (15-DaCompany Report #GBS981102054 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS 10 MG AT Initial or Prolonged Cyanosis Health BEDTIME Depressed Level Of Professional Digoxin C Consciousness Warfarin C Peripheral Coldness 24-Jun-2005 12:19 PM Page: 503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/98ISR Number: 3170266-7Report Type:Expedited (15-DaCompany Report #GBS981101979 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Convulsion Health Other Intentional Self-Injury Professional Psychotic Disorder Date:12/14/98ISR Number: 3170268-0Report Type:Expedited (15-DaCompany Report #US_981214405 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa PS 30 MG/DAY Initial or Prolonged Professional Depakote C .. C Desipramine C Paxil C Date:12/14/98ISR Number: 3170295-3Report Type:Expedited (15-DaCompany Report #US_981214013 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Professional Date:12/14/98ISR Number: 3170540-4Report Type:Expedited (15-DaCompany Report #EWC981202170 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Increased Health Initial or Prolonged Diarrhoea Professional Hepatic Failure Company Hyponatraemia Representative Renal Failure Acute Date:12/14/98ISR Number: 3170541-6Report Type:Expedited (15-DaCompany Report #DE_981100634 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 15 MG 2 YR Initial or Prolonged Acidosis Health Haldol (Haloperidol) C Blood Ph Decreased Professional Truxal C Coma Diabetes Mellitus Insulin-Dependent Hyperglycaemia Nausea Date:12/14/98ISR Number: 3170592-1Report Type:Expedited (15-DaCompany Report #US_981113370 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Zyprexa PS UNK Professional Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardizem (Diltiazem Hydrochloride) C Date:12/14/98ISR Number: 3170594-5Report Type:Expedited (15-DaCompany Report #EWC981202172 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS 20 MG Initial or Prolonged Convulsion Health Depakine (Valproate Drug Level Above Professional Sodium) C Therapeutic Anafranil Electroencephalogram (Clomipramine Abnormal Hydrochloride) C Medication Error Akineton (Biperiden Hydrochloride) C Date:12/14/98ISR Number: 3170636-7Report Type:Expedited (15-DaCompany Report #EWC981102041 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa PS 10 MG/DAY Orthostatic Hypotension Health Fluoxetine SS 20 MG/DAY Pyrexia Professional Rivotril C Tonsillitis Other Clamoxyl C Weight Decreased Tonsillitis C Date:12/14/98ISR Number: 3170638-0Report Type:Expedited (15-DaCompany Report #EWC981102094 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa PS Suicide Attempt Health Laroxyl C Professional Tranxene C Company Tegretol C Representative Theralene C Other Date:12/14/98ISR Number: 3170652-5Report Type:Expedited (15-DaCompany Report #US_981214002 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Professional Date:12/14/98ISR Number: 3170654-9Report Type:Expedited (15-DaCompany Report #DE_981200683 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/98ISR Number: 3170683-5Report Type:Expedited (15-DaCompany Report #US_981214367 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Health Zyprexa PS 10 MG/ DAY Initial or Prolonged Hepatic Failure Professional Jaundice Date:12/14/98ISR Number: 3170684-7Report Type:Expedited (15-DaCompany Report #US_981214065 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS 15 MG/1 DAY Initial or Prolonged Condition Aggravated Professional Synthroid Hypothermia (Levothyroxine Sodium) C Klonopin (Clonazepam) C Date:12/15/98ISR Number: 3170438-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Zyprexa PS 10MG QD -SEE Hospitalization - Asthenia B5 1 YR Initial or Prolonged Blood Osmolarity Benadryl C Increased Confusional State Dehydration Depressed Level Of Consciousness Diabetes Mellitus Hyperglycaemia Lipase Increased Mental Impairment Pancreatitis Date:12/15/98ISR Number: 3171097-4Report Type:Expedited (15-DaCompany Report #7397339 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Health Depakane PS Abbott SYRUP Initial or Prolonged Drug Interaction Professional Olanzapine SS QD Drug Level Below Calcium Carbonate C Therapeutic Acetaminophen C Pneumonia Albuterol C Bisacodyl C Ipratropium C Lorazepam C Magnesium Hydroxide C Date:12/17/98ISR Number: 3172424-4Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Disorder Olanzapine PS 15 MG AM & HS Depakote C Triflupromazine C 24-Jun-2005 12:19 PM Page: 506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propranolol C Date:12/18/98ISR Number: 3172040-4Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Zyprexa PS ORAL 15MG PO QHS Joint Stiffness Muscle Rigidity Up And Down Phenomenon Date:12/18/98ISR Number: 3172430-XReport Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Zyprexa PS ORAL 5MG PO QHS Initial or Prolonged Nipple Pain Required Intervention to Prevent Permanent Impairment/Damage Date:12/18/98ISR Number: 3172431-1Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Twitching Zyprexa PS ORAL 12.5 MG PO Initial or Prolonged Tremor QHS Required Intervention to Prevent Permanent Impairment/Damage Date:12/18/98ISR Number: 3172613-9Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Zyprexa PS Eli Lilly ORAL 5 MG PO QHS Orthostatic Hypotension Pepcid C Sedation Lamicile Cream C Date:12/21/98ISR Number: 3172199-9Report Type:Expedited (15-DaCompany Report #8-98344-046A Age: Gender:Male I/FU:I Outcome PT Life-Threatening Diarrhoea Hospitalization - Headache Initial or Prolonged Joint Swelling Leukocytoclastic Vasculitis Nausea Oedema Peripheral Purulent Discharge Pyrexia Rash Erythematous Rash Pustular 24-Jun-2005 12:19 PM Page: 507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxic Epidermal Necrolysis Report Source Product Role Manufacturer Route Dose Duration Foreign Trevilor Tablets Health (Venlafaxine Professional Hydrochloride) PS ORAL 75 MG ONCE DAILY ORAL Hypnorex (Lithium Carbonate) Tablets SS ORAL 600 MG DAILY ORAL Imodium (Loperamide) Capsules SS ORAL 4 MG GIVEN ONLY ONCE ORAL Zyprexa (Olanzapine) Tablets SS ORAL 20 MG / 15 MG SEE IMAGE ORAL Zyprexa C Hypnorex C Ciatyl C Imodium C Date:12/21/98ISR Number: 3172308-1Report Type:Expedited (15-DaCompany Report #US_981214509 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS 20 MG/1 DAY Professional Depakote C Desipramine C Benadryl C Date:12/21/98ISR Number: 3172497-9Report Type:Expedited (15-DaCompany Report #CA_980600034 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Zyprexa PS 30 MG/DAY Bronchospasm Health Tegretol Condition Aggravated Professional (Carbamazepine) C Dyspnoea Becloforte Myocardial Infarction (Beclometasone Overdose Dipropionate) C Weight Increased Adalat (Nifedipine) C Ventolin (Salbutamol) C Lithium C Date:12/21/98ISR Number: 3172498-0Report Type:Expedited (15-DaCompany Report #DE_981200683 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS 10 MG/DAY Health Tavor (Lorazepam) C Professional Other 24-Jun-2005 12:19 PM Page: 508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/98ISR Number: 3172499-2Report Type:Expedited (15-DaCompany Report #US98010442A Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa PS 10 MG/1 DAY Dizziness Health Haloperidol C Therapeutic Agent Professional Cogentin(Benzatropin Toxicity Other e Mesilate) C Date:12/21/98ISR Number: 3172500-6Report Type:Expedited (15-DaCompany Report #US_981012018 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arterial Rupture Health Zyprexa PS 20 MG/1 DAY Hospitalization - Cerebrovascular Accident Professional Depakote (Valproate Initial or Prolonged Coma Semisodium) C Haemorrhagic Stroke Folic Acid C Thrombotic Thrombocytopenic Purpura Date:12/21/98ISR Number: 3172513-4Report Type:Expedited (15-DaCompany Report #GBS981001802 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcohol Interaction Foreign Zyprexa PS 10 MG DAY Blindness Transient Health Professional Other Date:12/21/98ISR Number: 3172514-6Report Type:Expedited (15-DaCompany Report #EWC981001759 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS Initial or Prolonged Intentional Misuse Health Tranxene Miosis Professional (Clorazepate Sedation Dipotassium) C Suicide Attempt Date:12/21/98ISR Number: 3172517-1Report Type:Expedited (15-DaCompany Report #US_981012355 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Coma Dehydration Diabetic Ketoacidosis Fatigue Hyperglycaemia Hyperphagia Increased Appetite Neuroleptic Malignant Syndrome Pneumonia Aspiration Polyuria Pyrexia Simple Partial Seizures 24-Jun-2005 12:19 PM Page: 509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Thirst Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 10 MG/1 DAY 5 WK Professional Prozac SS 40 MG DAY 5 WK Date:12/21/98ISR Number: 3172520-1Report Type:Expedited (15-DaCompany Report #EWC981202231 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperreflexia Foreign Zyprexa PS Initial or Prolonged Hypertension Health Seroxat C Hypertonia Professional Tachycardia Other Date:12/21/98ISR Number: 3172523-7Report Type:Expedited (15-DaCompany Report #DE_981100653 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blister Foreign Zyprexa PS 10 MG Hospitalization - Corneal Disorder Health Trevilor C Initial or Prolonged Dermatitis Bullous Professional Hypnorex C Diarrhoea Imodium C Headache Praxiten C Nausea Novalgin C Purulence Paracetamol C Rash Erythematous Swelling Toxic Epidermal Necrolysis Vasculitis Date:12/21/98ISR Number: 3172526-2Report Type:Expedited (15-DaCompany Report #US_981214573 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Zyprexa PS 10 MG/1 DAY 2 YR Hospitalization - Phosphokinase Increased Professional Paxil C Initial or Prolonged Body Temperature Company Increased Representative Coma Movement Disorder Muscle Rigidity Neuroleptic Malignant Syndrome Renal Failure Tachycardia Date:12/21/98ISR Number: 3172527-4Report Type:Expedited (15-DaCompany Report #US_981214461 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa PS 10 MG/1 DAY 2 YR Congestive Professional Lasix C Pulmonary Hypertension Company Potassium C Representative Lotensin C Nitro C 24-Jun-2005 12:19 PM Page: 510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin C Rezulin C Humulin N C Humulin 70/30 C Glucophage C Lodine C Compazine C Atrovent C Date:12/22/98ISR Number: 3173416-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Olanzapine PS Abnormal Procardia X-L C Myocardial Ischaemia Vasotec C Sinus Arrhythmia Digoxin C Sinus Tachycardia Colace C Supraventricular Extrasystoles Supraventricular Tachycardia Ventricular Hypertrophy Date:12/29/98ISR Number: 3174436-3Report Type:Expedited (15-DaCompany Report #001-0991-981987 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Health Rezulin Initial or Prolonged Dehydrogenase Increased Professional (Troglitazone) PS ORAL 600 MG Fluid Retention Company (,DAILY), PER Hepatic Cirrhosis Representative ORAL Mania Zyprexa (Olanzapine) SS Oedema Diabeta Oedema Peripheral (Glibenclamide) C Splenomegaly Synthroid (Levothyroxine Sodium) C Premarin (Estrogens Conjugated) C Resperdal (Risperidone) C Bumex (Bumetanide) (Potassium) C Depakote (Valproate Semisodium) C Thiothixene (Tiotixene) C Ferrous Sulfate C Date:12/30/98ISR Number: 3176251-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Olanzapine PS ORAL Benztropine SS ORAL 0.5 MG PO QHS 24-Jun-2005 12:19 PM Page: 511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/98ISR Number: 3228512-7Report Type:Periodic Company Report #9716809 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Vistaril Capsules PS ORAL 37.50 MG Professional TOTAL: TID: ORAL Olanzapine SS ORAL ORAL Date:12/31/98ISR Number: 3177050-9Report Type:Expedited (15-DaCompany Report #US_981214792 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa PS 17.5 MG/DAY Prolonged Professional Mellaril SS Depakote(Valproate Semisodium) C Tofranil (Imipramine Hydrochloride) C Date:12/31/98ISR Number: 3177053-4Report Type:Expedited (15-DaCompany Report #US_981214784 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS 300 MG DAY Initial or Prolonged Alkalosis Professional Depakote (Valproate Ammonia Increased Semisodium) C Aspiration Prozac (Fluoxetine Blood Bicarbonate Hydrochloride) C Decreased Blood Ph Increased Blood Potassium Decreased Coma Cough Drug Level Below Therapeutic Hepatic Encephalopathy Hypertension Hyperventilation Intentional Misuse Oxygen Saturation Increased Pco2 Decreased Polyuria Productive Cough Pyrexia Retching Suicide Attempt Tachycardia Vomiting Date:12/31/98ISR Number: 3177057-1Report Type:Expedited (15-DaCompany Report #US_981214351 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Zyprexa PS 2.5 MG/DAY Initial or Prolonged Myocardial Infarction Professional Sinemet C 24-Jun-2005 12:19 PM Page: 512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/98ISR Number: 3177060-1Report Type:Expedited (15-DaCompany Report #DE_981200703 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Zyprexa PS 10 MG Inadequate Control Health Acarbose C Leukopenia Professional Pancytopenia Red Blood Cell Count Decreased Thrombocytopenia Date:12/31/98ISR Number: 3177064-9Report Type:Expedited (15-DaCompany Report #EWC981202245 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Xanax (Aprazolam) C Professional Betaloc (Metoprolol Company Tartrate) C Representative Other Date:12/31/98ISR Number: 3177068-6Report Type:Expedited (15-DaCompany Report #EWC981202264 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Haemorrhagic Stroke Health Magnyl C Professional Lasix (Furosemide) C Other Digoxin C Kaleorid (Potassium Chloride) C Date:12/31/98ISR Number: 3177070-4Report Type:Expedited (15-DaCompany Report #EWC981202278 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa (Olanzapine) PS Health Professional Other Date:12/31/98ISR Number: 3177073-XReport Type:Expedited (15-DaCompany Report #EWC981202279 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Suicidal Ideation Health Professional Other 24-Jun-2005 12:19 PM Page: 513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/98ISR Number: 3177074-1Report Type:Expedited (15-DaCompany Report #CA_981200273 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa PS 10 MG/1 DAY Life-Threatening Amnesia Health Prozac (Fluoxetine Hospitalization - Balance Disorder Professional Hydrochloride) C Initial or Prolonged Blood Pressure Increased Benztropine C Body Temperature Allopurinol C Increased Indomethacin C Cardiac Failure Monopril (Fosinopril Cardio-Respiratory Arrest Sodium) C Confusional State Tylenol W/Codeine Convulsion No. 3 C Depressed Level Of Consciousness Dysarthria Dyskinesia Faecal Incontinence Hallucination Hearing Impaired Heart Rate Increased Hyperhidrosis Myoglobin Urine Neuroleptic Malignant Syndrome Respiratory Failure Urinary Incontinence Date:12/31/98ISR Number: 3177075-3Report Type:Expedited (15-DaCompany Report #EWC981202323 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 560 MG/DAY Initial or Prolonged Arrhythmia Health Crying Professional Hypotension Other Muscle Rigidity Overdose Pyrexia Rhabdomyolysis Tachycardia Urinary Incontinence Date:12/31/98ISR Number: 3177076-5Report Type:Expedited (15-DaCompany Report #DE_981200696 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Zyprexa PS 12.5 MG/DAY Initial or Prolonged Health Doxepin C Professional Date:12/31/98ISR Number: 3177078-9Report Type:Expedited (15-DaCompany Report #EWC981202324 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Leukopenia Foreign Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Olanzapine PS 20 MG/DAY Zoloft (Sertraline Hydrochloride) C Date:12/31/98ISR Number: 3177079-0Report Type:Expedited (15-DaCompany Report #DE_981200700 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Foreign Zyprexa PS 15 MG/DAY Prolonged Health Tiapride C Professional Date:12/31/98ISR Number: 3177080-7Report Type:Expedited (15-DaCompany Report #US_981215029 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional Date:12/31/98ISR Number: 3177082-0Report Type:Expedited (15-DaCompany Report #DE_981200715 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Diarrhoea Health Quilonum (Lithium Initial or Prolonged Gait Disturbance Professional Acetate) C Headache L-Thyroxin C Respiratory Failure Antagonil(Nicardipin Vomiting e Hydrochloride) C Date:12/31/98ISR Number: 3177104-7Report Type:Expedited (15-DaCompany Report #GBS980901485 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa (Olanzapine) PS Transient Ischaemic Health Attack Professional Company Representative Other Date:12/31/98ISR Number: 3177221-1Report Type:Expedited (15-DaCompany Report #US_980909641 Age:49 YR Gender:Male I/FU:F Outcome PT Death Anaemia Other Hepatic Cirrhosis Hepatic Failure Hepatic Neoplasm Malignant Hepatitis C Lymphadenopathy Neoplasm 24-Jun-2005 12:19 PM Page: 515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Testicular Germ Cell Cancer Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 10 MG/1 DAY Professional Wellbutrin C Date:12/31/98ISR Number: 3177222-3Report Type:Expedited (15-DaCompany Report #US_981112712 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS 10 MG/1 DAY Overdose Professional Depakote C Wellbutrin C Date:12/31/98ISR Number: 3177223-5Report Type:Expedited (15-DaCompany Report #GBS981102054 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS 10 MG AT Initial or Prolonged Cyanosis Health BEDTIME Depressed Level Of Professional Digoxin C Consciousness Warfarin C Peripheral Coldness Date:12/31/98ISR Number: 3177224-7Report Type:Expedited (15-DaCompany Report #GBS980600705 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Health Professional Company Representative Date:12/31/98ISR Number: 3177225-9Report Type:Expedited (15-DaCompany Report #GBS980700986 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Fall Health Fracture Professional Hepatic Rupture Intra-Abdominal Haemorrhage Leg Amputation Polytraumatism Splenic Rupture Date:12/31/98ISR Number: 3177226-0Report Type:Expedited (15-DaCompany Report #EWC981001856 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphonia Foreign Zyprexa PS 15 MG/DAY Laryngeal Disorder Health Zyprexa SS 10 MG/ DAY Laryngospasm Professional Deroxat C Torticollis Largactil C 24-Jun-2005 12:19 PM Page: 516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/99ISR Number: 3193018-0Report Type:Periodic Company Report #7397018 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Abbott - Depakote PS Abbott ORAL 500.000 MG Visual Disturbance Professional PO TID Zyprexa SS ORAL 10.000 MG PO QD Date:01/08/99ISR Number: 3178696-4Report Type:Expedited (15-DaCompany Report #DE_981200700 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Electrocardiogram Qt Health Tiapride C Prolonged Professional Date:01/08/99ISR Number: 3178900-2Report Type:Expedited (15-DaCompany Report #AU_981200404 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Zyprexa PS 50 MG/1 DAY Electrocardiogram Health Flupenthixol C Abnormal Professional Date:01/08/99ISR Number: 3178901-4Report Type:Expedited (15-DaCompany Report #DE_981200749 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 10 MG 2 MON Initial or Prolonged Phosphokinase Increased Health Cardiomyopathy Professional Date:01/08/99ISR Number: 3178906-3Report Type:Expedited (15-DaCompany Report #US_981214784 Age:33 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Alkalosis Ammonia Increased Aspiration Blood Bicarbonate Decreased Blood Ph Increased Blood Pressure Fluctuation Coma Cough Heart Rate Increased Hepatic Encephalopathy Hypertension Hyperventilation Hypokalaemia Intentional Misuse Lung Disorder Pco2 Decreased Pneumonia Aspiration Polyuria 24-Jun-2005 12:19 PM Page: 517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Retching Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Zyprexa PS 300 MG DAY Vomiting Professional Depakote C Prozac C Date:01/08/99ISR Number: 3178907-5Report Type:Expedited (15-DaCompany Report #US_981214461 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa PS 10 MG/1 DAY 2 YR Congestive Professional Lasix C Cyanosis Company Potassium Chloride C Dyspnoea Representative Lotensin C Hypoxia Nitro Patch C Oedema Neurontin C Pulmonary Hypertension Rezulin C Humulin N C Humulin 70/30 C Glucophage C Lodine C Compazine C Atrovent C Date:01/08/99ISR Number: 3179056-2Report Type:Expedited (15-DaCompany Report #EWC981202381 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS 20 MG/DAY Initial or Prolonged Health Xanax C Professional Other Date:01/08/99ISR Number: 3179058-6Report Type:Expedited (15-DaCompany Report #GBS981202235 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS 10 MG DAY Initial or Prolonged Ventricular Tachycardia Health Depixol C Professional Paroxetine C Other Date:01/08/99ISR Number: 3179060-4Report Type:Expedited (15-DaCompany Report #US-981215277 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Zyprexa PS 2.5 MG/DAY Abnormal Professional Date:01/11/99ISR Number: 3179532-2Report Type:Expedited (15-DaCompany Report #LBID002990002 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Drug Level Above 24-Jun-2005 12:19 PM Page: 518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Feeling Drunk Nausea Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Lithobid PS ORAL 600 MG, PER DAY, PER ORAL Zyprexa SS ORAL PER ORAL Benzotropine SS ORAL PER ORAL Wellbutrin SS Neurontin SS ORAL PER ORAL Klonopin SS ORAL PER ORAL Ambien SS ORAL PER ORAL Zoloft SS ORAL PER ORAL Lithobid SS ORAL 600 MG, PER DAY, PER ORAL Date:01/11/99ISR Number: 3295476-XReport Type:Periodic Company Report #US_980910541 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amblyopia Consumer Evista (Raloxifene Nausea Hydrochloride) PS 60 MG/DAY Sedation Zyprexa (Olanzapine) SS 1.25 MG/DAY 2 MON Date:01/13/99ISR Number: 3180109-3Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Zyprexa PS 5MG IN THE Hospitalization - Asthenia MORNING (WAS Initial or Prolonged Dizziness 20 MG) Disability Dry Mouth Other Eye Disorder Required Fall Intervention to Hyperhidrosis Prevent Permanent Hypersensitivity Impairment/Damage Lip Disorder Malaise Muscle Rigidity Tongue Paralysis Tremor Weight Decreased Date:01/13/99ISR Number: 3180385-7Report Type:Expedited (15-DaCompany Report #AU_990100407 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Pulmonary Embolism Health Prednisolone C Thinking Abnormal Professional Asthma Medication C Lasix C Date:01/13/99ISR Number: 3180393-6Report Type:Expedited (15-DaCompany Report #GBS981001708 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Mania Foreign Initial or Prolonged Consumer 24-Jun-2005 12:19 PM Page: 519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Company Product Role Manufacturer Route Dose Duration Representative Zyprexa (Olanzapine) PS Date:01/13/99ISR Number: 3180395-XReport Type:Expedited (15-DaCompany Report #US_990115331 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Health Zyprexa PS 10 MG/2 DAY Initial or Prolonged Haematocrit Increased Professional Haldol C Haemorrhage Pancreatitis Acute Pyrexia Date:01/14/99ISR Number: 3180958-1Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Consumer Zyrtec PS Pfizer Zyprexa SS Lilly Date:01/14/99ISR Number: 3180984-2Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa PS ORAL 5MG PO BID Dyskinesia Professional DECREASED FROM TID Date:01/19/99ISR Number: 3182115-1Report Type:Expedited (15-DaCompany Report #EWC990102403 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Initial or Prolonged Eyelid Oedema Health Trilafon Neutropenia Professional (Perphenazine) C Pyrexia Leponex (Clozapine) C Bactrim C Date:01/19/99ISR Number: 3182167-9Report Type:Expedited (15-DaCompany Report #US_990115442 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Zyprexa PS Initial or Prolonged Professional Date:01/19/99ISR Number: 3182168-0Report Type:Expedited (15-DaCompany Report #EWC990102496 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Atrioventricular Block Foreign Olanzapine PS 10 MG/DAY First Degree Health Akineton C Electrocardiogram Professional Serenase C Abnormal Other Melleril C 24-Jun-2005 12:19 PM Page: 520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Temazepam C Date:01/19/99ISR Number: 3182802-5Report Type:Expedited (15-DaCompany Report #DE_981200749 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Blood Creatine Health Leponex (Clozapine) C Phosphokinase Mb Professional Increased Echocardiogram Abnormal Myocardial Infarction Date:01/19/99ISR Number: 3182806-2Report Type:Expedited (15-DaCompany Report #EWC980901577 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parosmia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Tranxene Professional (Clorazepate Dipotassium) C Date:01/19/99ISR Number: 3182812-8Report Type:Expedited (15-DaCompany Report #EWC981001726 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Hospitalization - Cyanosis Health Clomipramine C Initial or Prolonged Dyspnoea Professional Thyrax Electrolyte Imbalance (Levothyroxine) C Hepatic Function Abnormal Propranolol C Hepatosplenomegaly Lithium C Hyperglycaemia Hyperkalaemia Hyponatraemia Hypotension Metabolic Acidosis Muscle Rigidity Myalgia Respiratory Failure Splenomegaly Tachycardia Date:01/19/99ISR Number: 3182814-1Report Type:Expedited (15-DaCompany Report #US_980502956 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Completed Suicide Health Loxapac (Loxapine Overdose Professional Succinate) C 24-Jun-2005 12:19 PM Page: 521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/99ISR Number: 3182818-9Report Type:Expedited (15-DaCompany Report #US_981011746 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Hospitalization - Brain Herniation Professional Ativan (Lorazepam) C Initial or Prolonged Brain Oedema Circulatory Collapse Convulsion Encephalopathy Hypokalaemia Hyponatraemia Loss Of Consciousness Respiratory Arrest Subarachnoid Haemorrhage Date:01/19/99ISR Number: 3182821-9Report Type:Expedited (15-DaCompany Report #US_90115331 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Decreased Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Coma Professional Haldol (Haloperidol) C Haematocrit Decreased Haemorrhage Pancreatitis Acute Pyrexia Date:01/19/99ISR Number: 3385943-2Report Type:Periodic Company Report #US_980707201 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lipase Increased Health Zyprexa (Olanzapine) PS 20 MG/DAY Professional Vancocin (Vancomycin Hydrochloride) SS Effexor (Venlafaxine Hydrochloride) C Lasix (Furosemide) C Premarin (Estrogens Conjugated) C Prilosec (Omeprazole) C Date:01/21/99ISR Number: 3183255-3Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Zyprexa PS ORAL 20MG AT HS PO Initial or Prolonged Depakote C Disability Temazepain C Vicodin C Date:01/22/99ISR Number: 3184028-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Ibuprofen PS ORAL 600 MG TID Muscle Spasms Olanzapine SS ORAL 10 MG TID Tachycardia 24-Jun-2005 12:19 PM Page: 522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/99ISR Number: 3185761-4Report Type:Expedited (15-DaCompany Report #US_981012271 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Consumer Zyprexa (Olanzapine) PS 8 MON Dry Mouth Health Vision Blurred Professional Weight Increased Date:01/25/99ISR Number: 3185763-8Report Type:Expedited (15-DaCompany Report #US-981215029 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional Date:01/25/99ISR Number: 3185765-1Report Type:Expedited (15-DaCompany Report #US_990115442 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Haematocrit Decreased Professional Mellaril C Haemoglobin Decreased Trazodone C Leukopenia Lorazepam C Neutropenia Beconase C Date:01/25/99ISR Number: 3185768-7Report Type:Expedited (15-DaCompany Report #US-981012209 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Zyprexa (Olanzapine) PS Lorazepam C Sertraline C Date:01/25/99ISR Number: 3185770-5Report Type:Expedited (15-DaCompany Report #US_981012207 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Zyprexa (Olanzapine) PS Date:01/25/99ISR Number: 3185788-2Report Type:Expedited (15-DaCompany Report #US_990115758 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa PS 20 MG/1 AT Insomnia Health BEDTIME Professional Valium C Date:01/25/99ISR Number: 3185791-2Report Type:Expedited (15-DaCompany Report #US_990115843 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Status Epilepticus Health Zyprexa PS 10 MG/1 DAY 5 MON Professional Synthroid C Klonopin C Propranolol C 24-Jun-2005 12:19 PM Page: 523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/99ISR Number: 3185798-5Report Type:Expedited (15-DaCompany Report #US_981011746 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Zyprexa PS 10 MG / 2DAY Hospitalization - Balance Disorder Professional Ativan C Initial or Prolonged Brain Herniation Brain Hypoxia Brain Oedema Coma Delirium Diarrhoea Dyspnoea Encephalopathy Hyponatraemia Loss Of Consciousness Lung Infiltration Nervous System Disorder Pneumonia Pulmonary Congestion Pulmonary Oedema Respiratory Arrest Restlessness Salivary Hypersecretion Sedation Stupor Syncope Date:01/25/99ISR Number: 3185801-2Report Type:Expedited (15-DaCompany Report #US_990115829 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa PS 600 MG/1DAY Drug Level Above Health Therapeutic Professional Intentional Misuse Date:01/25/99ISR Number: 3185806-1Report Type:Expedited (15-DaCompany Report #GBS990102351 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa PS Health Lithium C Professional Procyclidine C Other Date:01/25/99ISR Number: 3185811-5Report Type:Expedited (15-DaCompany Report #EWC990102525 Age:23 YR Gender:Male I/FU:I Outcome PT Death Anxiety Hospitalization - Bradycardia Initial or Prolonged Carcinoid Tumour Pulmonary Chest Pain Circulatory Collapse Dyspnoea Electrocardiogram Qt Prolonged 24-Jun-2005 12:19 PM Page: 524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Nausea Pain In Extremity Report Source Product Role Manufacturer Route Dose Duration Pallor Foreign Zyprexa PS 20 MG/DAY Paraesthesia Health Pulmonary Embolism Professional Respiratory Rate Other Increased Shock Sinus Tachycardia Visual Disturbance Date:01/25/99ISR Number: 3185923-6Report Type:Expedited (15-DaCompany Report #EWC981202170 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Foreign Zyprexa PS 20 MG/DAY 5 MON Hospitalization - Asthenia Health Largactil C Initial or Prolonged Blood Creatinine Professional Sulfarlem C Increased Company Loxapac C Diarrhoea Representative Parkinane C Hepatic Failure Noctran C Hyponatraemia Depamide C Jaundice Maalox C Renal Failure Acute Stupor Vomiting Date:01/27/99ISR Number: 3186686-0Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS Lilly Professional Celexa SS Forest Pharmaceuticals Date:02/01/99ISR Number: 3189583-XReport Type:Expedited (15-DaCompany Report #EWC990102559 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Opiates Positive Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Akineton Retard Professional (Biperiden Company Hydrochloride) C Representative Cisordinol Other (Clopenthixol Hydrochloride) C Date:02/01/99ISR Number: 3189585-3Report Type:Expedited (15-DaCompany Report #EWC990102560 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Leukocytoclastic Vasculitis Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Subcutaneous Haematoma Thrombin Time Prolonged Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Health Carbamazepine C Professional Clomipramine C Other Temazepam C Lithium C Konakion (Phytomenadione) C Date:02/01/99ISR Number: 3189587-7Report Type:Expedited (15-DaCompany Report #US_990116378 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Literature Zyprexa (Olanzapine) PS 40 MG/1 DAY 2 MON Coronary Artery Disease Haloperidol C Hypertensive Heart Cyclobenzaprine C Disease Clonazepam C Valproic Acid C Risperidone C Fluphenazine C Fluvoxamine C Date:02/01/99ISR Number: 3189604-4Report Type:Expedited (15-DaCompany Report #US_990115646 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Olanzapine PS 15 MG; 4 Study DAY Health Nitrazepam C Professional Neutrophils C Other ... C Date:02/01/99ISR Number: 3189775-XReport Type:Expedited (15-DaCompany Report #EWC990102581 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS 10 MG/DAY Cardiac Disorder Health Serdolect C Condition Aggravated Professional Dalmadorm C Cough Other Oxazepam C Drug Interaction Electrocardiogram Qt Corrected Interval Prolonged Lung Disorder Pneumonia Sedation Sleep Apnoea Syndrome Snoring 24-Jun-2005 12:19 PM Page: 526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3189779-7Report Type:Expedited (15-DaCompany Report #US_981011229 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Health Zyprexa PS 15 MG/DAY 1 WK Other Increased Professional Blood Urea Increased Company Pneumonia Representative Renal Failure Respiratory Failure Date:02/01/99ISR Number: 3189797-9Report Type:Expedited (15-DaCompany Report #CA_981100218 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Foreign Zyprexa PS 2.5 MG/2 DAY Mesenteric Vein Health Thrombosis Professional Company Representative Date:02/01/99ISR Number: 3189814-6Report Type:Expedited (15-DaCompany Report #US_981012271 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Consumer Zyprexa PS 20 MG/1 AT Condition Aggravated Health BEDTIME Diabetic Ketoacidosis Professional Paxil C Dry Mouth Trazodone C Hepatic Steatosis Lithonate C Hepatomegaly Buspar C Pulmonary Congestion Speech Disorder Thirst Toxicologic Test Abnormal Vision Blurred Weight Increased Date:02/01/99ISR Number: 3189819-5Report Type:Expedited (15-DaCompany Report #US_981112712 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS 10 MG/1 DAY Overdose Professional Depakote C Pulmonary Congestion Wellbutrin C Pulmonary Oedema Toxicologic Test Abnormal Date:02/01/99ISR Number: 3189822-5Report Type:Expedited (15-DaCompany Report #US_990115829 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Literature Zyprexa PS 600 MG/I DAY Completed Suicide Health Drug Level Above Professional Therapeutic Intentional Misuse 24-Jun-2005 12:19 PM Page: 527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3189828-6Report Type:Expedited (15-DaCompany Report #US_981214573 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Zyprexa PS 10 MG/1 DAY 2 YR Hospitalization - Blood Creatine Professional Paxil C Initial or Prolonged Phosphokinase Increased Company Coma Representative Electroencephalogram Abnormal Hyperpyrexia Hypertension Hypoxia Muscle Rigidity Nervous System Disorder Neuroleptic Malignant Syndrome Renal Failure Rhabdomyolysis Syncope Tachycardia Date:02/01/99ISR Number: 3189832-8Report Type:Expedited (15-DaCompany Report #US_981113199 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Consumer Zyprexa PS 5 MG/1 DAY Other Cerebrovascular Accident Health Hydrochlorothiazide C Convulsion Professional K-Dur C Dementia Alzheimer'S Type Norvasc C Date:02/01/99ISR Number: 3189845-6Report Type:Expedited (15-DaCompany Report #US_990115843 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Withdrawal Health Zyprexa (Olanzapine) PS 10 MG / 1 DAY Convulsions Professional Synthroid C Screaming Klonopin C Status Epilepticus Propranolol C Date:02/01/99ISR Number: 3189864-XReport Type:Expedited (15-DaCompany Report #GBS980600705 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Drowning Health Family Stress Professional Company Representative Date:02/01/99ISR Number: 3189889-4Report Type:Expedited (15-DaCompany Report #GBS990102395 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa PS 90 MG Initial or Prolonged Health Venlafaxine C Professional Other 24-Jun-2005 12:19 PM Page: 528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3189893-6Report Type:Expedited (15-DaCompany Report #US_990116232 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa PS Prolonged Professional Remeron C Date:02/01/99ISR Number: 3190233-7Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Olanzapine PS Lilly ORAL 20 MG (2X10 Initial or Prolonged Miosis MG) QD (PO) Pallor Date:02/01/99ISR Number: 3209239-4Report Type:Expedited (15-DaCompany Report #EWC981001734 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Diabetes Mellitus Literature Clomipramine C Electrolyte Imbalance Health Hypercholesterolaemia Professional Hyperglycaemia Hyperhidrosis Hypertriglyceridaemia Increased Appetite Polydipsia Thirst Date:02/01/99ISR Number: 3311574-6Report Type:Periodic Company Report #US_981113302 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS Professional Depakote (Valproate Semisodium) C Date:02/01/99ISR Number: 3311579-5Report Type:Periodic Company Report #US_981113174 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa (Olanzapine) PS Professional Company Representative Date:02/01/99ISR Number: 3311583-7Report Type:Periodic Company Report #US_981113132 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa Professional (Olanzapine) PS 5 MG/DAY 3 DAY Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C 24-Jun-2005 12:19 PM Page: 529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Date:02/01/99ISR Number: 3311586-2Report Type:Periodic Company Report #US_981113087 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa (Olanzapine) PS 15 MG/DAY Psychotic Disorder Professional Precose (Acarbose) C Luvox (Fluvoxamine Maleate) C Date:02/01/99ISR Number: 3311589-8Report Type:Periodic Company Report #US_981113016 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Health Zyprexa (Olanzapine) PS Professional Oral Contraceptive Company Nos C Representative Date:02/01/99ISR Number: 3311591-6Report Type:Periodic Company Report #US_981112877 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa (Olanzapine) PS 30 MG/DAY Professional Date:02/01/99ISR Number: 3311595-3Report Type:Periodic Company Report #US_981112814 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa (Olanzapine) PS Professional Ambien (Zolpidem Tartrate) C Benadryl (Diphenhydramine Hydrochloride) C Colace (Docusate Sodium) C Potassium C Lasix (Furosemide) C Desyrel (Trazodone Hydrochloride) C Sulindac C Vicodin C Acetaminophen C Date:02/01/99ISR Number: 3311599-0Report Type:Periodic Company Report #US_981112768 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Disorder Health Zyprexa Growth Accelerated Professional (Olanzapine) PS 10 MG Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Date:02/01/99ISR Number: 3311604-1Report Type:Periodic Company Report #US_981112800 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Consumer Zyprexa Iron Deficiency Anaemia (Olanzapine) PS 15 MG/DAY Leukopenia Famotidine C Date:02/01/99ISR Number: 3311609-0Report Type:Periodic Company Report #US_981012561 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa (Olanzapine) PS 15 MG Professional Depakote (Valproate Company Semisodium) C Representative Date:02/01/99ISR Number: 3311613-2Report Type:Periodic Company Report #US_981012487 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nail Disorder Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Nortriptyline C Date:02/01/99ISR Number: 3311619-3Report Type:Periodic Company Report #US_981012493 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vaginal Haemorrhage Health Zyprexa (Olanzapine) PS 15 MG/DAY Professional Cogentin (Benzatropine Mesilate) C Klonopin (Clonazepam) C Glucophage (Metformin Hydrochloride) C Glucotrol Xl (Glipizide) C Date:02/01/99ISR Number: 3311623-5Report Type:Periodic Company Report #US_981012369 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coagulation Time Consumer Zyprexa Prolonged (Olanzapine) PS 5 MG/ DAY Zoloft (Sertraline Hydrochloride) C Trazodone C 24-Jun-2005 12:19 PM Page: 531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3311628-4Report Type:Periodic Company Report #US_981012268 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Zyprexa Professional (Olanzapine) PS 15 MG/ 1 DAY 6 WK Tegretol (Carbamazepine) C Ativan (Lorazepam) C Date:02/01/99ISR Number: 3311633-8Report Type:Periodic Company Report #US_981012273 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa Professional (Olanzapine) PS 10 MG/ DAY Navane (Tiotixene) C Date:02/01/99ISR Number: 3311637-5Report Type:Periodic Company Report #US_981012030 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Catatonia Health Zyprexa (Olanzapine) PS Professional Company Representative Date:02/01/99ISR Number: 3311641-7Report Type:Periodic Company Report #US_981011976 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa Iron Deficiency Anaemia Professional (Olanzapine) PS 20 MG/ DAY Jaundice Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Ambien (Zolpidem Tartrate) C Folic Acid C Date:02/01/99ISR Number: 3311645-4Report Type:Periodic Company Report #US_981011493 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urogenital Disorder Health Zyprexa Professional (Olanzapine) PS 7.5 MG/ DAY Company Representative Date:02/01/99ISR Number: 3311649-1Report Type:Periodic Company Report #US_981011087 Age: Gender:Female I/FU:I Outcome PT Report Source Therapeutic Response Health Unexpected Professional 24-Jun-2005 12:19 PM Page: 532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG/ DAY Date:02/01/99ISR Number: 3311653-3Report Type:Periodic Company Report #US_980910712 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 20 MG/ DAY 6 MON Professional Coumadin (Warfarin Sodium) C Ativan (Lorazepam) C Tylenol (Paracetamol) C Date:02/02/99ISR Number: 3196633-3Report Type:Periodic Company Report #US_981011219 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Nervousness Health Haldol C Schizophreniform Disorder Professional Cogentin C Sedation Speech Disorder Date:02/02/99ISR Number: 3196634-5Report Type:Periodic Company Report #US_981011398 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Study Olanzapine PS 2.5 MG/D DAY Life-Threatening Pneumonia Health Zinc Sulfate C Hospitalization - Sepsis Professional Ascorbic Acid C Initial or Prolonged Furosemide C Terazosin C Potassium Chloride C Senna C Date:02/02/99ISR Number: 3196635-7Report Type:Periodic Company Report #US_981011547 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 10 MG/QPM IN Initial or Prolonged Major Depression Health THE EVENING Professional Placebo SS 20 MG/QAM IN THE MORNING Tylenol C Date:02/02/99ISR Number: 3196636-9Report Type:Periodic Company Report #US_981011614 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Study Olanzapine PS 10 MG/QHS AT Hospitalization - Health BEDTIME Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196637-0Report Type:Periodic Company Report #US_981011638 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 20 MG/D DAY Initial or Prolonged Overdose Health Professional Date:02/02/99ISR Number: 3196638-2Report Type:Periodic Company Report #US_981011682 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zypexa PS 30 MG/1 DAY Initial or Prolonged Overdose Professional Valproic Acid C Amantadine C Date:02/02/99ISR Number: 3196639-4Report Type:Periodic Company Report #US_981011749 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Diabetes Mellitus Health Diabetic Ketoacidosis Professional Hyperventilation Weight Increased Date:02/02/99ISR Number: 3196640-0Report Type:Periodic Company Report #US_981011754 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Study Olanzapine PS Health Professional Date:02/02/99ISR Number: 3196641-2Report Type:Periodic Company Report #US_981011756 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 5 MG/DAY Hospitalization - Health Initial or Prolonged Professional Date:02/02/99ISR Number: 3196642-4Report Type:Periodic Company Report #US_981011759 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Olanzapine PS 5 MG/D DAY Initial or Prolonged Rhabdomyolysis Health Aspirin C Professional Prinivil C Vitamin C C Zyrtec C Vitamin E C 24-Jun-2005 12:19 PM Page: 534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196643-6Report Type:Periodic Company Report #US_981011786 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Study Olanzapine PS 10 MG/D DAY Dementia Alzheimer'S Type Health Lasix C Professional Zyprexa C Aleve C Date:02/02/99ISR Number: 3196644-8Report Type:Periodic Company Report #US_981011898 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa (Olanzapine) PS 500 MG Initial or Prolonged Intentional Misuse Professional Effexor C Suicide Attempt Company Serax C Thrombocytopenia Representative Cytomel C Estrace C Duratuss C Advil C Pepcid C Vitamin E C Date:02/02/99ISR Number: 3196645-XReport Type:Periodic Company Report #US_981012006 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acidosis Study Olanzapine PS 10 MG/HS AT Hospitalization - Dehydration Health BEDTIME Initial or Prolonged Hypotension Professional Fluoxetine Myocardial Infarction (Fluoxetine Pancreatitis Hydrochloride) SS 20 MG/D DAY Pneumonia Prilosec C Respiratory Disorder Levoxyl C Urinary Tract Infection Albuterol C Azmacort C Date:02/02/99ISR Number: 3196646-1Report Type:Periodic Company Report #US_981012012 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/QPM IN Initial or Prolonged Gastritis Health THE EVENING Gastrointestinal Disorder Professional Prozac (Fluoxetine Pneumonia Hydrochloride) SS 40 MG/QAM IN THE MORNING Humulin Nph C Humulin Regular C Aleve C Rezulin C Prilosec C Date:02/02/99ISR Number: 3196647-3Report Type:Periodic Company Report #US_981012182 Age:68 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Cerebral Infarction Study Olanzapine PS 7.5 MG/QHS AT Sedation Health BEDTIME Professional Hyoscyamine C Hydroxyzine C Warfarin C Omeprazole C Simvastatin C Dehydroepiandrostero ne C Dexamethasoone C Citalopram C Date:02/02/99ISR Number: 3196648-5Report Type:Periodic Company Report #US_981012296 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS Initial or Prolonged Hallucination Professional Risperdal C Intentional Misuse Company Lithium C Representative Sodium Chloride C Albuterol C Novolin N C Duragesic C Date:02/02/99ISR Number: 3196649-7Report Type:Periodic Company Report #US_981012401 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Mellaril C Depakote C Catapres C Date:02/02/99ISR Number: 3196743-0Report Type:Periodic Company Report #US_981012404 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional Date:02/02/99ISR Number: 3196744-2Report Type:Periodic Company Report #US_981012406 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Zyprexa (Olanzapine) PS Initial or Prolonged Hypotonia Health Risperidone C Sedation Professional Synthroid C Stupor Other Accupril C 24-Jun-2005 12:19 PM Page: 536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196745-4Report Type:Periodic Company Report #US_981012436 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Study Olanzapine PS 15 MG/D DAY Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/D DAY Amaryl C Date:02/02/99ISR Number: 3196786-7Report Type:Periodic Company Report #US_980300839 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Sepsis Health Multivitamin C Professional Micro K Extencaps C Triamterene/Hydrochl orothiazide C Date:02/02/99ISR Number: 3196788-0Report Type:Periodic Company Report #US97101204A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 1 YR Initial or Prolonged Diabetes Mellitus Professional Lamictal C Weight Increased Lithium C Paroxetine C Date:02/02/99ISR Number: 3196790-9Report Type:Periodic Company Report #US97102155A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 8 MON Initial or Prolonged Diabetes Mellitus Professional Depakote C Diabetic Ketoacidosis Fungal Infection Weight Increased Date:02/02/99ISR Number: 3196793-4Report Type:Periodic Company Report #US97102230A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 20 MG/1 DAY 6 MON Initial or Prolonged Drug Ineffective Professional Tegretol C Weight Increased Clonazepam C Date:02/02/99ISR Number: 3196795-8Report Type:Periodic Company Report #US97103394A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Study Zyprexa (Olanzapine) PS 5 MG/1 DAY Hospitalization - Dehydration Health Allegra C Initial or Prolonged Hypernatraemia Professional Synthroid C Lung Disorder Lorazepam C Pneumonia Pyrexia 24-Jun-2005 12:19 PM Page: 537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196797-1Report Type:Periodic Company Report #US_980300927 Age:2 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Health Digoxin C Professional Enalapril C Synthroid C Furosemide C Nitro-Bid C Potassium C Trental C Date:02/02/99ISR Number: 3196799-5Report Type:Periodic Company Report #US_980401803 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 5 MG/ 2 DAY Initial or Prolonged Mania Health Ativan C Professional Lithium C Benadryl C Date:02/02/99ISR Number: 3196801-0Report Type:Periodic Company Report #US_980503937 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Dehydration Professional Thiothixene C Dysuria Valproic Acid C Glycosuria Paroxetine C Hyperglycaemia Medroxyprogesterone C Hyponatraemia Ketoacidosis Oedema Peripheral Polyuria Sedation Thirst Urinary Tract Infection Weight Decreased Date:02/02/99ISR Number: 3196803-4Report Type:Periodic Company Report #US_980606080 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 4 DSQ FORM/D Initial or Prolonged Depression Health DAY Hallucination Professional Placebo SS Hostility Olanzapine C Mania Lorazepam C Paranoia Levothyroxine C Carbamazepine C Ranitidine C Effexor C Ativan C 24-Jun-2005 12:19 PM Page: 538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196805-8Report Type:Periodic Company Report #US_980706498 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Influenza Like Illness Professional Psychotic Disorder Other Pyrexia Tachycardia Date:02/02/99ISR Number: 3196807-1Report Type:Periodic Company Report #US_98070282 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Zyprexa (Olanzapine) PS 460 MG/DAY Initial or Prolonged Intentional Misuse Professional Temazepam C Nervousness Buspar C Speech Disorder Benadryl C Date:02/02/99ISR Number: 3196810-1Report Type:Periodic Company Report #US_980808159 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Drug Ineffective Health Intentional Misuse Professional Date:02/02/99ISR Number: 3196812-5Report Type:Periodic Company Report #US_980808391 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS 20 MG/D DAY 256 DAY Initial or Prolonged Hallucination Health Micronase C Schizophreniform Disorder Professional Premarin C Vitamin E C Triamcinolone C Nizoral Skin Cream C Multivitamin C Date:02/02/99ISR Number: 3196814-9Report Type:Periodic Company Report #US_980808453 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Health Professional Other Date:02/02/99ISR Number: 3196816-2Report Type:Periodic Company Report #US_980808476 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS 20 MG/1 DAY Initial or Prolonged Drug Ineffective Health Trazodone C Psychotic Disorder Professional Mellaril C Other Klonopin C Haldol C 24-Jun-2005 12:19 PM Page: 539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196818-6Report Type:Periodic Company Report #US_980808481 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Anxiety Health Mellaril C Psychotic Disorder Professional Ativan C Date:02/02/99ISR Number: 3196820-4Report Type:Periodic Company Report #US_980808739 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Study Olanzapine PS 2.5 MG/D DAY Hospitalization - Health Lisinopril C Initial or Prolonged Professional Furosemide C Vitamin B12 C Folic Acid C Nifedipine C Meclizine C Artificial Tears C Levothyroxine C Digoxin C Multivitamin C Date:02/02/99ISR Number: 3196822-8Report Type:Periodic Company Report #US_980808887 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG/D DAY Initial or Prolonged Hallucination Health Placebo SS 2 MG/D DAY Insomnia Professional Lorazepam C Schizophreniform Disorder Date:02/02/99ISR Number: 3196825-3Report Type:Periodic Company Report #US_980809101 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Hallucination Health Clozapine C Professional Other Date:02/02/99ISR Number: 3196827-7Report Type:Periodic Company Report #US_980809159 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Drug Ineffective Health Professional Other Date:02/02/99ISR Number: 3196835-6Report Type:Periodic Company Report #US_980910146 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Professional Valproate Sodium C 24-Jun-2005 12:19 PM Page: 540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196837-XReport Type:Periodic Company Report #US_980910237 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa (Olanzapine) PS Initial or Prolonged Hyperglycaemia Professional Lithium Carbonate C Other Date:02/02/99ISR Number: 3196838-1Report Type:Periodic Company Report #US_980910267 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG /1 DAY Initial or Prolonged Health Professional Other Date:02/02/99ISR Number: 3196840-XReport Type:Periodic Company Report #US_980910352 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amblyopia Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Grand Mal Convulsion Professional Zoloft C Sedation Company Representative Date:02/02/99ISR Number: 3196841-1Report Type:Periodic Company Report #US_980910372 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Study Olanzapine PS 2.5 MG Initial or Prolonged Health Rocephin C Professional Prednisone C Folic Acid C Synthroid C Oxycontin C Senokot C Diflucan C Date:02/02/99ISR Number: 3196844-7Report Type:Periodic Company Report #US_980910641 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Olanzapine PS Initial or Prolonged Health Risperidone C Professional Fluoxetine C Bactrim C Congentin C Olanzapine C Colace C Benzoyl Peroxide C Cleocin C Clozaril C Depakote C Ranitidine C Vitamin E C 24-Jun-2005 12:19 PM Page: 541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196846-0Report Type:Periodic Company Report #US_980910655 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG D/ DAY Initial or Prolonged Dystonia Health Placebo SS 2 MG/ D DAY Vomiting Professional Pyridoxine C Weight Decreased Glyburide C Percocet C Ativan C Lisinopril C Isoniazid C Acetaminophen C Date:02/02/99ISR Number: 3196850-2Report Type:Periodic Company Report #US_980910707 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Olanzapine PS 10 MG /D DAY Initial or Prolonged Health Placebo SS 2 MG /D DAY Professional Amlodipine C Cimetidine C Folic Acid C Mvi C Thiamine C Date:02/02/99ISR Number: 3196853-8Report Type:Periodic Company Report #US_980910730 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Zyprexa PS 2.5 MG 2 DAY Hospitalization - Phosphokinase Abnormal Professional Haldol C Initial or Prolonged Convulsion Other Hypertonia Hypotension Neuroleptic Malignant Syndrome Pupillary Disorder Pyrexia Tachycardia Date:02/02/99ISR Number: 3196859-9Report Type:Periodic Company Report #US_980910825 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 2.5 MG/HS AT Initial or Prolonged Health BEDTIME Professional Remeron C Levoxyl C Restoril C Milk Of Magnesia C Pepcid C Dulcolax C Metamucil C Colace C Ativan C Desyrel C 24-Jun-2005 12:19 PM Page: 542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196861-7Report Type:Periodic Company Report #US_980910963 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Sedation Professional Acetaminophen C Lorazepam C Paxil C Levaquine C Date:02/02/99ISR Number: 3196863-0Report Type:Periodic Company Report #US_980910966 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 2.5 MG /1 DAY Professional Depakote C Company Representative Date:02/02/99ISR Number: 3196865-4Report Type:Periodic Company Report #US_981011079 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Literature Zyprexa (Olanzapine) PS 600 MG Initial or Prolonged Coma Health Other Hypoventilation Professional Intentional Misuse Stupor Tachycardia Date:02/02/99ISR Number: 3196867-8Report Type:Periodic Company Report #US_981011107 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa (Olanzapine) PS 20 MG /DAY Diabetic Ketoacidosis Professional Depakote C Hyperglycaemia Date:02/02/99ISR Number: 3196869-1Report Type:Periodic Company Report #US_981011191 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 1 YR Initial or Prolonged Intentional Misuse Professional Sedation Stupor Date:02/02/99ISR Number: 3196871-XReport Type:Periodic Company Report #US_981011199 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 5 MG/ D DAY Initial or Prolonged Health Lithium C Professional 24-Jun-2005 12:19 PM Page: 543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3196872-1Report Type:Periodic Company Report #US_981011212 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG/D DAY Initial or Prolonged Health Placebo SS 40 MG/ D DAY Professional Zantac C Premarin C Tenoretic C Arthrotec C Date:02/02/99ISR Number: 3198621-XReport Type:Periodic Company Report #US_981113204 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Date:02/02/99ISR Number: 3198625-7Report Type:Periodic Company Report #US_981113348 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 5 MG/ D DAY Initial or Prolonged Health Lithium C Professional Prozac C Restoril C Date:02/02/99ISR Number: 3198626-9Report Type:Periodic Company Report #US_981113379 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 10 MG Initial or Prolonged Suicide Attempt Health Professional Date:02/02/99ISR Number: 3198630-0Report Type:Periodic Company Report #US_981113448 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS 20 MG Initial or Prolonged Health Ativan C Professional Haldol C Navane C Inderal C Date:02/02/99ISR Number: 3198633-6Report Type:Periodic Company Report #US_981113449 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Study Olanzapine PS 5 MG/QHS AT Initial or Prolonged Health BEDTIME Professional Depakote C Propulsid C Prevacid C St. John'S Wort C 24-Jun-2005 12:19 PM Page: 544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198634-8Report Type:Periodic Company Report #US_981113571 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Other Zyprexa (Olanzapine) PS Initial or Prolonged Pyrexia Risperdal C Date:02/02/99ISR Number: 3198638-5Report Type:Periodic Company Report #US_981214425 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 15 MG/DAILY Initial or Prolonged Health DAY Professional Cogentin C Effexor C Date:02/02/99ISR Number: 3198642-7Report Type:Periodic Company Report #US_981214505 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 3 DSY Initial or Prolonged Health FORM/DAILY Professional DAY Date:02/02/99ISR Number: 3198643-9Report Type:Periodic Company Report #US_981113621 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Injury Professional Salivary Hypersecretion Company Syncope Representative Urinary Tract Infection Date:02/02/99ISR Number: 3198646-4Report Type:Periodic Company Report #US_981214506 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Initial or Prolonged Laboratory Test Abnormal Clindamycin C Stupor Levaquin C Thinking Abnormal Fragmin C Albuterol C Atrovent C Date:02/02/99ISR Number: 3198647-6Report Type:Periodic Company Report #US_981113703 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Suicide Attempt Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Ativan C Tylenol C Day Pro C Naprosyn C 24-Jun-2005 12:19 PM Page: 545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C Klonopin C Seroquel C Date:02/02/99ISR Number: 3198650-6Report Type:Periodic Company Report #US_981214682 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Study Olanzapine PS 20 MG/1 DAY Increased Health Aspartate Professional Aminotransferase Increased Date:02/02/99ISR Number: 3198652-XReport Type:Periodic Company Report #US_981113736 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG/D DAY Initial or Prolonged Schizophreniform Disorder Health Depakote C Professional Lithium C Vistaril C Date:02/02/99ISR Number: 3198654-3Report Type:Periodic Company Report #US_981214696 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5MG/1 DAY Initial or Prolonged Health Valproic Acid C Professional Valproic Acid C Date:02/02/99ISR Number: 3198655-5Report Type:Periodic Company Report #US_981113754 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 15 MG/ MG AM, Initial or Prolonged Health 10 MG HS DAY Professional Placebo SS 2 MG / 2 DAY Gemfibrozil C Divalproex Sodium C Diazepam C Date:02/02/99ISR Number: 3198659-2Report Type:Periodic Company Report #US_981214699 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG/1 DAY Initial or Prolonged Health ... C Professional 24-Jun-2005 12:19 PM Page: 546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198662-2Report Type:Periodic Company Report #US_981214701 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/DAILY Initial or Prolonged Health DAY Professional Placebo SS 2 MG/DAILY DAY Lisinopril C Date:02/02/99ISR Number: 3198667-1Report Type:Periodic Company Report #US_981214718 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG Initial or Prolonged Health Professional Date:02/02/99ISR Number: 3198671-3Report Type:Periodic Company Report #US_981214925 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Gait Disturbance Oedema Peripheral Weight Increased Date:02/02/99ISR Number: 3198678-6Report Type:Periodic Company Report #US_981214970 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Study Olanzapine PS 10 MG/DAILY Initial or Prolonged Hyponatraemia Health DAY Professional Placebo SS Date:02/02/99ISR Number: 3198681-6Report Type:Periodic Company Report #US_981214999 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 30 MG/1 DAY Syndrome Professional Clozaril C Prozac C Phenobarbital C Niferex C Date:02/02/99ISR Number: 3198686-5Report Type:Periodic Company Report #US_981215194 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Drug Dependence Health Placebo SS 2 MG Injury Professional Atenolol C Diphenhydramine C Gentamicin C Multivitamin C Timolol Maleate C 24-Jun-2005 12:19 PM Page: 547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198689-0Report Type:Periodic Company Report #US_981215222 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS 10 MG/1 DAY Initial or Prolonged Health Lanoxin C Professional Cardura C Allopurinol C Aspirin C Theragran-M C Atrovent C Furosemide C Date:02/02/99ISR Number: 3198690-7Report Type:Periodic Company Report #US_981113872 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Study Olanzapine PS 5 MG/HS AT Initial or Prolonged Thinking Abnormal Health BEDTIME Urinary Incontinence Professional Buspirone C Docusate Sodium C Psyllium C Ketoconazole C Date:02/02/99ISR Number: 3198693-2Report Type:Periodic Company Report #US_981215243 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 2 MG/AT Initial or Prolonged Health BEDTIME Professional Placebo SS Didanosine C Lamivudine C Zidovudine C Trazodone C Combivir C Nelfinavir C Cimetidine C Multivitamins C Date:02/02/99ISR Number: 3198694-4Report Type:Periodic Company Report #US_981213999 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Olanzapine PS 15 MG Initial or Prolonged Otitis Media Health Prozac C Professional Synthroid C Date:02/02/99ISR Number: 3198698-1Report Type:Periodic Company Report #US_981214028 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Citalopram C Other Plaquenil C 24-Jun-2005 12:19 PM Page: 548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198699-3Report Type:Periodic Company Report #US_981215247 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 15 MG/DAY Initial or Prolonged Health Lithium C Professional Prozac C Restoril C Date:02/02/99ISR Number: 3198701-9Report Type:Periodic Company Report #US_981214120 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Orthostatic Hypotension Professional Nicotine Transdermal Other System C Depakote C Remeron C Date:02/02/99ISR Number: 3198703-2Report Type:Periodic Company Report #US_981215248 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Study Olanzapine PS 7.5 MG/1 DAY Life-Threatening Health Professional Date:02/02/99ISR Number: 3198706-8Report Type:Periodic Company Report #US_981214128 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Olanzapine PS 10 MG / AT Initial or Prolonged Health BEDTIME AT Professional BEDTIME Prozac (Fluoxetine Hydrochloride) SS 20 MG/ IN THE MORNING IN THE MORNING Ativan C Lotensin C Naprosyn C Cimetidine C Date:02/02/99ISR Number: 3198708-1Report Type:Periodic Company Report #US_981214135 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Increased Appetite Zoloft C Weight Increased Dilantin C Probenecid C Inderal C Coumadin C 24-Jun-2005 12:19 PM Page: 549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198711-1Report Type:Periodic Company Report #US_981214199 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Confusional State Professional Risperdal C Neuroleptic Malignant Other Syndrome Sedation Date:02/02/99ISR Number: 3198715-9Report Type:Periodic Company Report #US_981214251 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 15 MG/1 DAY 2 WK Professional Date:02/02/99ISR Number: 3198718-4Report Type:Periodic Company Report #US_981214302 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS Initial or Prolonged Overdose Professional Lorazepam C Company Representative Date:02/02/99ISR Number: 3198723-8Report Type:Periodic Company Report #US_981214327 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG Initial or Prolonged Health Placebo SS Professional Date:02/02/99ISR Number: 3198726-3Report Type:Periodic Company Report #US_981214423 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 4 DSG FORM / Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM / MORNING AND BEDTIME DAY Haldol C Cogentin C Date:02/02/99ISR Number: 3198730-5Report Type:Periodic Company Report #US_981012449 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 250 MG/1 DAY Initial or Prolonged Convulsion Professional Zoloft C Delirium Xanax C Depression Intentional Misuse Suicide Attempt Thinking Abnormal 24-Jun-2005 12:19 PM Page: 550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198734-2Report Type:Periodic Company Report #US_981012545 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5 MG/D DAY Initial or Prolonged Health Bentyl C Professional Date:02/02/99ISR Number: 3198738-XReport Type:Periodic Company Report #US_981012594 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 10 MG/HS AT Initial or Prolonged Hallucination Health BEDTIME Paranoia Professional Date:02/02/99ISR Number: 3198741-XReport Type:Periodic Company Report #US_981012619 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 20 MG/DAY 1 DAY Professional Depakote C Company Risperidone C Representative Date:02/02/99ISR Number: 3198746-9Report Type:Periodic Company Report #US_981112680 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Study Olanzapine PS 15 MG/HS AT Life-Threatening Health BEDTIME Hospitalization - Professional Lotensin C Initial or Prolonged Glucotrol C Aspirin C Ibuprofen C Date:02/02/99ISR Number: 3198750-0Report Type:Periodic Company Report #US_981112812 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Health Zoloft C Professional Procardia C Date:02/02/99ISR Number: 3198753-6Report Type:Periodic Company Report #US_981112821 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 30 MG/D DAY Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198756-1Report Type:Periodic Company Report #US_981112824 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG/D DAY Initial or Prolonged Psychotic Disorder Health Trazodone C Schizophreniform Disorder Professional Haldol C Klonopin C Date:02/02/99ISR Number: 3198760-3Report Type:Periodic Company Report #US_981112834 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 20 MG/D DAY Initial or Prolonged Suicide Attempt Health Tegretol C Professional Klonopin C Luvox C Date:02/02/99ISR Number: 3198763-9Report Type:Periodic Company Report #US_981112841 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 20 MG/D DAY Initial or Prolonged Suicide Attempt Health Xanax C Professional Date:02/02/99ISR Number: 3198767-6Report Type:Periodic Company Report #US_981112844 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG/D DAY Initial or Prolonged Schizophreniform Disorder Health Paxil C Professional Depakote C Date:02/02/99ISR Number: 3198770-6Report Type:Periodic Company Report #US_981112861 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Study Zyprexa (Olanzapine) PS 5 MG/D DAY Initial or Prolonged Health Lorazepam C Professional Potassium C Furosemide C Ultram C Claritin C Serzone C Vitamin B12 C Azmacort C Date:02/02/99ISR Number: 3198773-1Report Type:Periodic Company Report #US_981112881 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 2.5 MG/D DAY Initial or Prolonged Health Regular Insulin C Professional Terazosin C Fosinopril Sodium C Nitroglycerin C 24-Jun-2005 12:19 PM Page: 552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin C Lactulose C Insulin Humulin C Date:02/02/99ISR Number: 3198776-7Report Type:Periodic Company Report #US_981112907 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 2.5 MG/D DAY Initial or Prolonged Psychotic Disorder Health Paxil C Professional Depakote C Seroquel C Remeron C Date:02/02/99ISR Number: 3198779-2Report Type:Periodic Company Report #US_981112916 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG/QHS AT Initial or Prolonged Health BEDTIME Professional Lithium C Gemfibrozil C Lorazepam C Viagra C Benadryl C Synthroid C Date:02/02/99ISR Number: 3198782-2Report Type:Periodic Company Report #US_981112996 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Olanzapine PS 10 MG/HS AT Initial or Prolonged Health BEDTIME Professional Placebo SS Colace C Aspirin C Prophylaxis C Date:02/02/99ISR Number: 3198786-XReport Type:Periodic Company Report #US_981113065 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG/HS AT Initial or Prolonged Health BEDTIME Professional Placebo SS Lorazepam C Divalproex C Benztropine C Diphenhydramine C Fluphenazine C .. C Fluphenazine Decanoate C 24-Jun-2005 12:19 PM Page: 553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3198791-3Report Type:Periodic Company Report #US_981113074 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Health Placebo SS Professional Hydroxyzine C Trazodone C Ativan C Hydrochlorothiazide C Date:02/02/99ISR Number: 3198794-9Report Type:Periodic Company Report #US_981113076 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG/ D DAY Initial or Prolonged Hallucination Health Placebo SS Professional Zestril C Prolixin C Cogentin C Date:02/02/99ISR Number: 3198796-2Report Type:Periodic Company Report #US_981113149 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Literature Zyprexa (Olanzapine) PS 1 G/DAY Initial or Prolonged Intentional Misuse Health Miosis Professional Date:02/02/99ISR Number: 3309682-9Report Type:Periodic Company Report #US_980910536 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa (Olanzapine) PS 20 MG/DAY 1 YR Health Lithobid (Lithium Professional Carbonate) C Flax Seed Oil C Multivitamin C Vitamin E C Vasotec (Enalapril Maleate) C Date:02/02/99ISR Number: 3309685-4Report Type:Periodic Company Report #US_980909781 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 20 MG/DAY Professional Depakote C Date:02/02/99ISR Number: 3309687-8Report Type:Periodic Company Report #US_980909468 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa (Olanzapine) PS 30 MG/DAY Thrombocytopenia Professional Gabapentin C Clonazepam C Procardia 24-Jun-2005 12:19 PM Page: 554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xl(Nifedipine) C Date:02/02/99ISR Number: 3309692-1Report Type:Periodic Company Report #US97124762A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Professional Lithium C Ativan C Anafranil C Date:02/02/99ISR Number: 3309697-0Report Type:Periodic Company Report #US_981215164 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 25 MG/DAY Professional Date:02/02/99ISR Number: 3309840-3Report Type:Periodic Company Report #US_981215083 Age:15 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa (Olanzapine) PS Unevaluable Event Professional Date:02/02/99ISR Number: 3309841-5Report Type:Periodic Company Report #US_981215057 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa (Olanzapine) PS 40 MG/DAY Professional Date:02/02/99ISR Number: 3309843-9Report Type:Periodic Company Report #US_981214997 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Health Zyprexa (Olanzapine) PS Abnormal Professional Date:02/02/99ISR Number: 3309848-8Report Type:Periodic Company Report #US_981214954 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS 30 MG/DAY Professional Restoril C Company Colace C Representative Date:02/02/99ISR Number: 3309852-XReport Type:Periodic Company Report #US_981214872 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Mania Health Professional Company 24-Jun-2005 12:19 PM Page: 555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 2.5 MG 6 WK Date:02/02/99ISR Number: 3309855-5Report Type:Periodic Company Report #US_981214823 Age:3 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neonatal Disorder Zyprexa (Olanzapine) PS Sedation Tremor Date:02/02/99ISR Number: 3309858-0Report Type:Periodic Company Report #US_981214728 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa (Olanzapine) PS 15 MG/DAY 4 WK Professional Company Representative Date:02/02/99ISR Number: 3309861-0Report Type:Periodic Company Report #US_981214617 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa (Olanzapine) PS 15 MG/DAY 4 MON Professional Wellbutrin C Ativan C Date:02/02/99ISR Number: 3309864-6Report Type:Periodic Company Report #US_981214500 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS 25 MG/DAY Professional Depakene C Date:02/02/99ISR Number: 3309868-3Report Type:Periodic Company Report #US_981214354 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Health Zyprexa (Olanzapine) PS Professional Company Representative Date:02/02/99ISR Number: 3309877-4Report Type:Periodic Company Report #US_981214203 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 60 MG DAY Professional Company Representative 24-Jun-2005 12:19 PM Page: 556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3309878-6Report Type:Periodic Company Report #US_981214250 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Acne Health Zyprexa (Olanzapine) PS 32.5 MG/DAY 4 MON Intentional Misuse Professional Humulin-Human Lente Insulin (Rdna) (Human Insulin (Rdna Origin)) SS Cogentin C Retin A C Minocin C Date:02/02/99ISR Number: 3309879-8Report Type:Periodic Company Report #US_981214082 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa (Olanzapine) PS 20 MG/DAY Professional Fluphenazine C Company Amitriptyline C Representative Clonazepam C Date:02/02/99ISR Number: 3309881-6Report Type:Periodic Company Report #US_981214015 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Health Zyprexa (Olanzapine) PS Professional Date:02/02/99ISR Number: 3309886-5Report Type:Periodic Company Report #US_981113494 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa (Olanzapine) PS 12.5 MG/DAY 5 MON Professional Date:02/02/99ISR Number: 3309888-9Report Type:Periodic Company Report #US_981113497 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Health Zyprexa (Olanzapine) PS Abnormal Professional Date:02/02/99ISR Number: 3309892-0Report Type:Periodic Company Report #US_981113361 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Professional Paxil C Thyroxine C 24-Jun-2005 12:19 PM Page: 557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3309896-8Report Type:Periodic Company Report #US_981113375 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa (Olanzapine) PS 15 MG/DAY 3 WK Iron Deficiency Anaemia Professional Paxil C Leukopenia Company Ativan C Red Blood Cell Representative Abnormality Date:02/04/99ISR Number: 3192194-3Report Type:Direct Company Report # Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Zyprexa PS ORAL 5MG PO QHS/2.5 MG PO QD Date:02/04/99ISR Number: 3192283-3Report Type:Expedited (15-DaCompany Report #JAGER-42776 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blister Foreign Imodium (Loperamide) PS Janssen ORAL -, SINGLE Hospitalization - Diarrhoea Health ORAL Initial or Prolonged Leukocytoclastic Professional Trevilor Vasculitis (Venlafaxine) SS ORAL 75 MG; Nausea DAILY; ORAL 30 DAY Oedema Peripheral Zyprexa (Olanzapine) SS ORAL 20MG DAILY; Pain 15MG DAILY; Pyrexia 10MG DAILY; Toxic Epidermal ORAL; TABLET 38 DAY Necrolysis Hypnorex (Lithium Carbonate) SS ORAL 600 MG DAILY; ORAL; TABLET 400MG 17 DAY Ciatyl C Praxiten C Date:02/04/99ISR Number: 3300915-1Report Type:Periodic Company Report #M077880 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Serzone Tabs PS ORAL 600 MG QD Extrapyramidal Disorder Professional ORAL Zyprexa SS ORAL 10 MG QD ORAL Date:02/04/99ISR Number: 3301131-XReport Type:Periodic Company Report #M079263 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apraxia Health Serzone Tabs 100 Mg PS ORAL 100 MG ORAL Sedation Professional Klonopin SS ORAL 4 MG ORAL Zyprexa SS ORAL 15 MG ORAL 24-Jun-2005 12:19 PM Page: 558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/99ISR Number: 3307130-6Report Type:Periodic Company Report #M086504 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Serzone Tabs PS ORAL 50 MG BID Professional ORAL 3 DAY Tegretol SS Zyprexa SS Date:02/05/99ISR Number: 3198903-1Report Type:Periodic Company Report #FLUV002980127 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Luvox Tablets Initial or Prolonged Depression Professional (Fluvoxamine Erectile Dysfunction Maleate) PS ORAL 300 MG ,PER Mania ORAL Zyprexa (Olanzapine) SS ORAL 2.5 MG , PER ORAL St. John'S Wort SS ORAL PER ORAL Date:02/05/99ISR Number: 3199055-4Report Type:Periodic Company Report #FLUV002980098 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Health Luvox Tablets 100 Mg Initial or Prolonged Hyperbilirubinaemia Professional (Fluvoxamine Jaundice Maleate) PS ORAL 200 MG , PER Pruritus ORAL Zyprexa (Olanzapine) SS ORAL 5 MG PER ORAL Ativan C Date:02/05/99ISR Number: 3199108-0Report Type:Periodic Company Report #FLUV002980072 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granuloma Health Luvox Tablets 50 Mg Rash Maculo-Papular Professional (Fluvoxamine Skin Nodule Maleate) PS ORAL 150 MG A.M. AND 100 MG P.M. PER ORAL Zyprexa SS ORAL PER ORAL Furosemide C Insulin C Klonopin C Date:02/08/99ISR Number: 3193879-5Report Type:Expedited (15-DaCompany Report #F/98/01273/LEX Age:34 YR Gender:Female I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Asthenia Required Drug Withdrawal Syndrome Intervention to Dyskinesia Prevent Permanent Extrapyramidal Disorder Impairment/Damage Hyperhidrosis 24-Jun-2005 12:19 PM Page: 559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Bronchial Secretion Lung Disorder Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Health Leponex (Clozapine) PS ORAL 800 MG ORAL Professional Zyprexa (Olanzapine) SS Seresta (Oxazepam) C Chronadalate (Nifedipine) C Lipanthyl (Fenofibrate) C Date:02/08/99ISR Number: 3193963-6Report Type:Expedited (15-DaCompany Report #US_990115843 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disseminated Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Other Intravascular Coagulation Professional Synthroid Myocardial Infarction (Levothyroxine Screaming Sodium) C Status Epilepticus Klonopin (Clonazepam) C Propranolol C Date:02/08/99ISR Number: 3193967-3Report Type:Expedited (15-DaCompany Report #DE_981200749 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Zyprexa (Olanzapine) PS 15 MG Initial or Prolonged Blood Creatine Health Leponex (Clozapine) C Phosphokinase Increased Professional Drug Ineffective Other Myalgia Myocardial Infarction Myocarditis Pain In Extremity Date:02/08/99ISR Number: 3193970-3Report Type:Expedited (15-DaCompany Report #GBS990102351 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa (Olanzapine) PS Neutropenia Health Lithium C Professional Procyclidine C Other Date:02/08/99ISR Number: 3193972-7Report Type:Expedited (15-DaCompany Report #US_981214065 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa Belligerence Professional (Olanzapine) PS 15 MG/ 1 DAY Condition Aggravated Synthroid Hypothermia (Levothyroxine Sodium) C Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/99ISR Number: 3193973-9Report Type:Expedited (15-DaCompany Report #DE_981200700 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Electrocardiogram Qt Health Tiapride C Prolonged Professional Other Date:02/08/99ISR Number: 3194093-XReport Type:Expedited (15-DaCompany Report #DE_990100829 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Stupor Health Supraventricular Professional Tachycardia Date:02/08/99ISR Number: 3194094-1Report Type:Expedited (15-DaCompany Report #DE_990100833 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Zyprexa (Olanzapine) PS 5 MG/ 4 DAY Initial or Prolonged Pyrexia Health White Blood Cell Count Professional Decreased Date:02/08/99ISR Number: 3194095-3Report Type:Expedited (15-DaCompany Report #GBS990102426 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Swelling Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Health Depixol C Professional Company Representative Date:02/08/99ISR Number: 3194096-5Report Type:Expedited (15-DaCompany Report #EWC990102587 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa (Olanzapine) PS Hospitalization - Blood Electrolytes Health Cisordinol C Initial or Prolonged Abnormal Professional Blood Pressure Fluctuation Carcinoid Tumour Of The Caecum Change Of Bowel Habit Intestinal Ulcer Malaise Nervous System Disorder Pallor 24-Jun-2005 12:19 PM Page: 561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/99ISR Number: 3194146-6Report Type:Expedited (15-DaCompany Report #EWC990102581 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa PS 10 MG/DAY Cough Health Serdolect C Drug Interaction Professional Dalmadorm C Lung Disorder Other Oxazepam C Pneumonia Sedation Sleep Apnoea Syndrome Snoring Date:02/08/99ISR Number: 3194234-4Report Type:Expedited (15-DaCompany Report #EWC 990102592 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Foreign Zyprexa PS 20 MG/DAY Drug Hypersensitivity Health Hyperkeratosis Professional Pruritus Company Representative Date:02/08/99ISR Number: 3194235-6Report Type:Expedited (15-DaCompany Report #US 990116597 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Zyprexa PS 7.5 MG/ 1 DAY Professional Tylenol C Antacids C Date:02/08/99ISR Number: 3194238-1Report Type:Expedited (15-DaCompany Report #US 990116651 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Zyprexa PS 5 MG/ 2 DAY Health Chlorpromazine C Professional Periciazine C Trihexyphenidyl C Date:02/08/99ISR Number: 3194241-1Report Type:Expedited (15-DaCompany Report #US 990116534 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Encephalopathy Health Zyprexa PS 10 MG/ 2 DAY Grand Mal Convulsion Professional Prozac C Hyponatraemia Company Remeron C Representative Inderal C Depakote C Risperdal C Date:02/08/99ISR Number: 3194244-7Report Type:Expedited (15-DaCompany Report #US 9901166971 Age:34 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Asthenia 24-Jun-2005 12:19 PM Page: 562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Dehydration Depressed Level Of Report Source Product Role Manufacturer Route Dose Duration Consciousness Health Zyprexa PS 20 MG/ 1 DAY 1 YR Diabetes Mellitus Professional Benadryl C Hyperglycaemia Other Hyperglycaemic Hyperosmolar Nonketotic Syndrome Lipase Increased Mental Impairment Pancreatitis Date:02/08/99ISR Number: 3194247-2Report Type:Expedited (15-DaCompany Report #EWC 990202629 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Zyprexa PS 10 MG/ DAY Initial or Prolonged Health Professional Date:02/08/99ISR Number: 3194251-4Report Type:Expedited (15-DaCompany Report #US 990116395 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS 10 MG/ 1 AT Initial or Prolonged Anxiety Health BEDTIME Asthenia Professional Prozac SS 20 MG/ IN THE Infection MORNING Multiple Sclerosis Ativan C Neutrophil Count Pepcid C Increased Ultram C Pain Pain In Extremity Sensory Loss Stress Tremor White Blood Cell Count Increased Date:02/08/99ISR Number: 3194260-5Report Type:Expedited (15-DaCompany Report #7396988 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Health Depakote PS Abbott ORAL 2.5 GM PO QD Inversion Professional Zyprexa SS 5 MG QD Other Prozac C Ibuprofen C Date:02/08/99ISR Number: 3196829-0Report Type:Periodic Company Report #US_980909624 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Olanzapine PS 2.5 MG/D DAY Initial or Prolonged Gastric Ulcer Perforation Health Zoloft C Professional Trazodone C Sinemet C 24-Jun-2005 12:19 PM Page: 563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mirapex C Magnesium C Calcium C Prempro C Date:02/08/99ISR Number: 3196831-9Report Type:Periodic Company Report #US_980909827 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Albuminuria Health Zyprexa PS 15 MG/DAY Diabetes Mellitus Professional Zantac C Polyuria Doxepin C Tachycardia Thirst Weight Decreased Date:02/08/99ISR Number: 3196833-2Report Type:Periodic Company Report #US_980910091 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 10 MG/DAY Initial or Prolonged Condition Aggravated Health Ibuprofen C Mania Professional Ephedrine C Psychotic Disorder Date:02/10/99ISR Number: 3194836-5Report Type:Direct Company Report # Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nipple Disorder Zyprexa PS 20 MG HS Nipple Pain Lithium C Swelling Mellaril C Date:02/10/99ISR Number: 3194918-8Report Type:Expedited (15-DaCompany Report #US_981214351 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Myocardial Infarction Professional Sinemet C Date:02/10/99ISR Number: 3195189-9Report Type:Direct Company Report # Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Zyprexa 10 Mg PS ORAL PO EVERY HS; Initial or Prolonged MAYBE B/T 1-4 MONTHS Date:02/11/99ISR Number: 3196194-9Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Zyprexa PS ORAL 10MG PO HS Rash Generalised Haldol Desanoate C Cogentin C 24-Jun-2005 12:19 PM Page: 564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/99ISR Number: 3198938-9Report Type:Direct Company Report #52035 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Pfizer Zyprexa SS Lilly Date:02/16/99ISR Number: 3199131-6Report Type:Expedited (15-DaCompany Report #US_990217114 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa (Olanzapine) PS Fall Professional Date:02/16/99ISR Number: 3199133-XReport Type:Expedited (15-DaCompany Report #EWC990202631 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Alcohol Problem Health Magnyl C Professional Temazepam "Nm Other Pharma" (Temazepam) C Zoloft (Sertraline Hydrochloride) C Date:02/16/99ISR Number: 3199144-4Report Type:Expedited (15-DaCompany Report #EWC990102614 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Foreign Zyprexa (Olanzapine) PS 25 MG/DAY Life-Threatening Laryngeal Oedema Health Diazepam C Obstructive Airways Professional Gabapentin C Disorder Date:02/16/99ISR Number: 3199186-9Report Type:Expedited (15-DaCompany Report #EWC990202661 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Blood Pressure Decreased Health Artane C Initial or Prolonged Central Venous Pressure Professional Lactulose C Increased Other Hydrocortisone C Chest Pain Electrocardiogram St Segment Elevation Fall Gastrointestinal Disorder Heart Rate Decreased Heart Rate Irregular Hyperventilation Malaise Myocardial Infarction Nausea Pallor Pyrexia Skin Discolouration Ventricular Tachycardia 24-Jun-2005 12:19 PM Page: 565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/99ISR Number: 3199453-9Report Type:Expedited (15-DaCompany Report #EWC981102144 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa (Olanzapine) PS Pulmonary Embolism Health Professional Other Date:02/16/99ISR Number: 3199454-0Report Type:Expedited (15-DaCompany Report #EWC990102525 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Bradycardia Health Initial or Prolonged Chest Pain Professional Circulatory Collapse Other Dyspnoea Echocardiogram Abnormal Electrocardiogram Abnormal Hyperhidrosis Ill-Defined Disorder Nausea Neoplasm Pain In Extremity Pallor Pulmonary Embolism Respiratory Rate Increased Shock Sinus Tachycardia Tachycardia Visual Disturbance Date:02/16/99ISR Number: 3199455-2Report Type:Expedited (15-DaCompany Report #DE_981200715 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Life-Threatening Diarrhoea Health Quilonum (Lithium Hospitalization - Gait Disturbance Professional Acetate) C Initial or Prolonged Headache Other L-Thyroxin Lung Disorder (Levothyroxine Pneumothorax Sodium) C Respiratory Failure Antagonil Vomiting (Nicardipine Hydrochloride) C Date:02/16/99ISR Number: 3199663-0Report Type:Expedited (15-DaCompany Report #EWC990202687 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Discomfort Health Drug Hypersensitivity Professional Urticaria 24-Jun-2005 12:19 PM Page: 566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/99ISR Number: 3199876-8Report Type:Expedited (15-DaCompany Report #EWC990102619 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Hospitalization - Health Initial or Prolonged Professional Company Representative Date:02/17/99ISR Number: 3200099-4Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Zyprexa PS 2.5 MG PO HS Professional Dexedrine C Lithium C Clonidine C Date:02/18/99ISR Number: 3201077-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Zyprexa PS ORAL BID ORAL Intervention to Rentid C Prevent Permanent Pernax C Impairment/Damage Ceplalerin C Kcl C Isosorbide Mononitak C Furpse,Otde C Sininet C Date:02/19/99ISR Number: 3202724-0Report Type:Expedited (15-DaCompany Report #7396988 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Health Abbott - Depakote PS Abbott ORAL 2.500 GM PO Dehydrogenase Increased Professional QD Drug Interaction Other Zyprexa SS 5.000 MG QD Electrocardiogram T Wave Zyprexa C Inversion Prozac C Ibuprofen C Date:02/19/99ISR Number: 3202727-6Report Type:Expedited (15-DaCompany Report #7396991 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Health Abbott - Depakote PS ORAL 2.500 GM PO Drug Interaction Professional QD Electrocardiogram T Wave Other Zyprexa SS 7.500 MG QD Inversion Zyprexa C Hyperhidrosis Isoniazid C Oedema Anafranil C Skin Discolouration Pyridoxine C Sluggishness Ibuprofen C Ventricular Hypertrophy Vitamin B6 C 24-Jun-2005 12:19 PM Page: 567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/99ISR Number: 3308556-7Report Type:Periodic Company Report #S98-USA-00920-01 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Celexa 20mg Tablets PS ORAL 20 MG ONCE Professional Zyprexa 10 Mg Tablets (Olanzapine) SS ORAL 10 MG ONCE Plquenil C Date:02/22/99ISR Number: 3204035-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Zyprexa 10 Mg Tablet PS ZYPREXA 10 MG Professional 2 TAB HS Date:02/22/99ISR Number: 3205718-4Report Type:Periodic Company Report #8-98316-099A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Effexor Xr Capsules PS ORAL ORAL Professional Zyprexa (Olanzapine) Company Tablets SS ORAL ORAL Representative Zyprexa C Date:02/23/99ISR Number: 3204557-8Report Type:Expedited (15-DaCompany Report #DE_981200703 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG / DAY Pancytopenia Health Acarbose C Red Blood Cell Count Professional Allopurinol C Decreased Prothazin Thrombocytopenia (Promethazine Hydrochloride) C Date:02/23/99ISR Number: 3204564-5Report Type:Expedited (15-DaCompany Report #US_990116534 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dementia Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Grand Mal Convulsion Professional Prozac (Fluoxetine Hyponatraemia Company Hydrochloride) C Representative Remeron (Mirtazapine) C Inderal (Propranolol Hydrochloride) C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/99ISR Number: 3204567-0Report Type:Expedited (15-DaCompany Report #US_990116597 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Electrocardiogram Professional Tylenol Abnormal (Paracetamol) C Syncope Vasovagal Antacids C Date:02/23/99ISR Number: 3204583-9Report Type:Expedited (15-DaCompany Report #DE_981200700 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Electrocardiogram Qt Health Tiapride C Prolonged Professional Date:02/23/99ISR Number: 3204754-1Report Type:Expedited (15-DaCompany Report #DE_990200877 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS 40 MG/DAY Health Lorazepam C Professional Other Date:02/23/99ISR Number: 3204756-5Report Type:Expedited (15-DaCompany Report #US_990217538 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Zyprexa PS 20 MG/1 DAY Initial or Prolonged Professional Dilantin C Mellaril C Stelazine C Date:02/23/99ISR Number: 3204757-7Report Type:Expedited (15-DaCompany Report #GBS990102378 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Monoparesis Foreign Zyprexa PS 10 MG DAY Ulnar Nerve Injury Health Orphenadrine C Professional Paroxetine C Other Date:02/23/99ISR Number: 3204758-9Report Type:Expedited (15-DaCompany Report #GBS990102431 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Zyprexa PS TRANSPLACENTAL 20 MG DAY Exposure To Therapeutic Health Paracetamol C Drugs Professional Dyhydrocodeine C Eye Movement Disorder Heparin C Jaundice Ibuprofen C 24-Jun-2005 12:19 PM Page: 569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/99ISR Number: 3204760-7Report Type:Expedited (15-DaCompany Report #EWC990202691 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa PS 10 MG/DAY Hospitalization - Anaemia Health Largactil C Initial or Prolonged Pyrexia Professional Orfidal C Other Date:02/23/99ISR Number: 3204762-0Report Type:Expedited (15-DaCompany Report #US_981113474 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zyprexa PS 10 MG/DAY Atrial Fibrillation Professional Paxil C Cardiac Failure Thyroid Replacement C Congestive Chills Cough Oedema Pyrexia Ventricular Extrasystoles Date:02/23/99ISR Number: 3204860-1Report Type:Expedited (15-DaCompany Report #EWC990202692 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Hospitalization - Pulmonary Oedema Health Valproate Sodium C Initial or Prolonged Renal Failure Professional Respiratory Failure Vomiting Date:02/25/99ISR Number: 3208142-3Report Type:Expedited (15-DaCompany Report #9906989 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Galactorrhoea Health Zoloft Tablets PS ORAL 150.00 MG Intervention to Pituitary Tumour Professional TOTAL; DAILY; Prevent Permanent ORAL Impairment/Damage Zyprexa SS ORAL 10.00 MG TOTAL; DAILY; ORAL Date:02/25/99ISR Number: 3209578-7Report Type:Periodic Company Report #9825936 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Consumer Zoloft Tablets PS ORAL 100.00 MG Menstrual Disorder TOTAL:DAILY:O Neurosis RAL Oedema Zyprexa SS ORAL ORAL Weight Increased Desipramine C Trilafon C Cogentin C 24-Jun-2005 12:19 PM Page: 570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3210137-0Report Type:Periodic Company Report #9820295 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Zoloft Tablets PS ORAL 50.00 MG Dry Mouth TOTAL: DAILY: Flatulence ORAL Depakote SS ORAL ORAL Zyprexa SS ORAL ORAL Synthroid C Premarin C Estrace C Testosterone C Diflucan C Vitamin C Calcium C Ibuprofen C Procerdia C Date:02/25/99ISR Number: 3210862-1Report Type:Periodic Company Report #9800445 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Zoloft Tablets PS ORAL 100.00 MG Professional TOTAL: DAILY: ORAL Zyprexa SS ORAL 10.00 MG TOTAL: DAILY: ORAL Date:02/25/99ISR Number: 3210883-9Report Type:Periodic Company Report #9807381 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Zoloft Tablets PS ORAL ORAL Cardiac Disorder Professional Zyprexa SS Eye Pain Glossitis Mydriasis Nausea Thinking Abnormal Vomiting Date:02/25/99ISR Number: 3212192-0Report Type:Periodic Company Report #JAUSA-34357 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL ORAL Olanzapine (Olanzapine) Capsules SS ORAL 10 MG 1 DAILY ORAL Clozaril (Clozapine) SS 24-Jun-2005 12:19 PM Page: 571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212656-XReport Type:Periodic Company Report #JAUSA-33681 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 5 MG 1 DAILY ORAL Olanzapine (Olanzapine) Capsules SS ORAL ORAL Date:02/25/99ISR Number: 3212661-3Report Type:Periodic Company Report #9802189 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Zoloft Tablets PS ORAL 100.00 MG Anxiety Health TOTAL: DAILY: Asthenia Professional ORAL Gait Disturbance Klonopin SS ORAL ORAL Insomnia Buspar SS ORAL ORAL Nausea Zyprexa SS ORAL ORAL Paraesthesia Atenolol C Sedation Vitamins C Tinnitus Date:02/25/99ISR Number: 3212712-6Report Type:Periodic Company Report #9802279 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Zoloft Tablets PS ORAL 300.00 MG Intentional Misuse TOTAL:DAILY:O Medication Error RAL Sedation Zyprexa SS ORAL ORAL Lithium C Date:02/25/99ISR Number: 3213167-8Report Type:Periodic Company Report #JAUSA-32912 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal PS ORAL PRN Zyprexa (Olanzapine) SS Date:02/25/99ISR Number: 3213219-2Report Type:Periodic Company Report #JAUSA-32230 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Health Risperdal Professional (Risperidone) PS Janssen ORAL 1.5 MG 1 DAILY ORAL Zyprexa (Olanzapine) Suspension SS ORAL 2.5 MG 1 DAILY ORAL Propulsid C Humulin 70/30 C Synthroid C Ferrous Sulfate C Hytrin C 24-Jun-2005 12:19 PM Page: 572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zocor C Erythropoietin C Calcitrol C Losartan C Phoslo C Darvon C Atenolol C Nephro-Vite C Lactulose C Date:02/25/99ISR Number: 3213417-8Report Type:Periodic Company Report #JAUSA-35112 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1MG 2 DAILY ORAL; 4 DOSES GIVEN Zyprexa (Olanzapine) Tablet SS ORAL ORAL Date:02/25/99ISR Number: 3213578-0Report Type:Periodic Company Report #JAUSA-35285 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Risperdal Initial or Prolonged Confusional State Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY Dyspnoea ORAL; .5 MG 1 Neuroleptic Malignant DAILY ORAL 3 DAY Syndrome Zyprexa (Olanzapine) Sedation Tablet 5 Mg SS ORAL 5 MG 2 DAILY Tachycardia ORAL Date:02/25/99ISR Number: 3214001-2Report Type:Periodic Company Report #JAUSA-35194 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Flushing Professional (Risperidone) Hypertrophy Breast Janssen, Tablet 1 Mg PS ORAL .5 MG 2 DAILY Weight Increased ORAL Risperdal (Risperidone) SS ORAL .5 MG 2 DAILY Zyprexa (Olanzapine) Tablet SS ORAL ORAL Date:02/26/99ISR Number: 3208073-9Report Type:Expedited (15-DaCompany Report #9908981 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Depakene PS Abbott ORAL 2.000 GM PO Initial or Prolonged Mania Health Zyprexa SS Other Oedema Peripheral Professional Serax C Platelet Count Decreased 24-Jun-2005 12:19 PM Page: 573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3216758-3Report Type:Periodic Company Report #8-98100-009A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Effexor PS ORAL 300 MG DAILY Asthenia ORAL 200 MG Dizziness DAILY 37.5 MG Drug Withdrawal Syndrome ONCE Influenza Like Illness Zyprexa (Olanzapine) Nausea Tablet SS ORAL 20 MG DAILY Nervousness TAPERED TO 10 Polyuria MG DAILY ORAL Urinary Incontinence Zyprexa C Vomiting Weight Increased Date:03/01/99ISR Number: 3209165-0Report Type:Expedited (15-DaCompany Report #US_990217114 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa (Olanzapine) PS Professional Date:03/01/99ISR Number: 3209169-8Report Type:Expedited (15-DaCompany Report #US_981214573 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 2 YR Hospitalization - Apnoea Professional Paxil (Paroxetine Initial or Prolonged Arrhythmia Company Hydrochloride) C Other Blood Creatine Representative Phosphokinase Increased Blood Pressure Increased Brain Stem Infarction Coma Electroencephalogram Abnormal Hypoxia Movement Disorder Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Renal Failure Rhabdomyolysis Syncope Tachycardia Date:03/01/99ISR Number: 3209228-XReport Type:Expedited (15-DaCompany Report #US_990217538 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Professional Dilantin C Mellaril C Stelazine C 24-Jun-2005 12:19 PM Page: 574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3209231-XReport Type:Expedited (15-DaCompany Report #EWC990202691 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Anaemia Health Largactil C Pyrexia Professional Orfidal C Other Date:03/01/99ISR Number: 3209234-5Report Type:Expedited (15-DaCompany Report #EWC990202631 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Alcohol Problem Health Magnyl C Professional Temazepam C Other Zoloft C Oxazepam C Date:03/01/99ISR Number: 3209244-8Report Type:Expedited (15-DaCompany Report #DE_990100833 Age:11 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Zyprexa (Olanzapine) PS 5 MG/4 DAY Initial or Prolonged Pyrexia Health White Blood Cell Disorder Professional Date:03/01/99ISR Number: 3209247-3Report Type:Expedited (15-DaCompany Report #CA_981100226 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 30 DSG FORM Intentional Misuse Health Imovane C Professional Company Representative Date:03/01/99ISR Number: 3209248-5Report Type:Expedited (15-DaCompany Report #US_980808312 Age:18 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Asthenia Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Diarrhoea Dysarthria Eye Movement Disorder Gaze Palsy Haemoglobinuria Hallucination Hyporeflexia Hypotonia Muscular Weakness Mydriasis Neuroleptic Malignant 24-Jun-2005 12:19 PM Page: 575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Ophthalmoplegia Rhabdomyolysis Serotonin Syndrome Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY White Blood Cell Count Professional Depakote C Increased Lithium C Date:03/01/99ISR Number: 3209304-1Report Type:Expedited (15-DaCompany Report #EWC990202778 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Flurazepam C Professional Other Date:03/01/99ISR Number: 3209376-4Report Type:Expedited (15-DaCompany Report #US_990217700 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Schizophrenia Study Seroxat C Health Valium C Professional Date:03/01/99ISR Number: 3209379-XReport Type:Expedited (15-DaCompany Report #DE_981000466 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malignant Ascites Foreign Zyprexa (Olanzapine) PS 20 MG DAY Ovarian Cancer Health Professional Date:03/01/99ISR Number: 3209381-8Report Type:Expedited (15-DaCompany Report #DE_990200886 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Leukopenia Health Leponex C Liver Function Test Professional Atosil C Abnormal Other Neutropenia Date:03/01/99ISR Number: 3209383-1Report Type:Expedited (15-DaCompany Report #DE_990200890 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Condition Aggravated Health Decentan C Lipid Metabolism Disorder Professional Neurocil C Liver Function Test Abnormal Pancreatic Enzymes Increased Pancreatitis 24-Jun-2005 12:19 PM Page: 576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3209385-5Report Type:Expedited (15-DaCompany Report #DE_990200903 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Pancreatitis Health Neurocil C Initial or Prolonged Professional Date:03/01/99ISR Number: 3209389-2Report Type:Expedited (15-DaCompany Report #DE_990200905 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Supraventricular Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Extrasystoles Health Dipiperon C Ventricular Extrasystoles Professional Cipramil C Xanef C Maninil "Berlin-Chemie" C Ass C Bifiteral C Date:03/01/99ISR Number: 3209390-9Report Type:Expedited (15-DaCompany Report #DE_990200911 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Pulmonary Embolism Health Venlafaxine C Professional Nefadar C Norvasc C Alprazolam C Valverde C Lasix C Date:03/01/99ISR Number: 3209392-2Report Type:Expedited (15-DaCompany Report #GBS980801209 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY Face Oedema Health Oedema Peripheral Professional Company Representative Other Date:03/01/99ISR Number: 3209397-1Report Type:Expedited (15-DaCompany Report #GBS990202621 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Disorder Foreign Zyprexa (Olanzapine) PS 30 MG/1 DAY Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3209399-5Report Type:Expedited (15-DaCompany Report #US_990217001 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Zyprexa (Olanzapine) PS 25 MG/1 DAY Professional Depakote C Thiothixene C Gemfibrozil C Glyburide C Cogentin C Date:03/01/99ISR Number: 3209400-9Report Type:Expedited (15-DaCompany Report #US_990217699 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Zyprexa (Olanzapine) PS 5 MG/1 AT Haemorrhage Health BEDTIME Neutropenia Professional Valproate Sodium C Date:03/01/99ISR Number: 3209402-2Report Type:Expedited (15-DaCompany Report #US_990217709 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Zyprexa (Olanzapine) PS 30 MG/1 DAY Initial or Prolonged Encephalopathy Professional Lithium C Mental Impairment Date:03/01/99ISR Number: 3209536-2Report Type:Expedited (15-DaCompany Report #US_990217714 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa (Olanzapine) PS 5MG / 1 DAY Initial or Prolonged Oesophageal Disorder Professional Oesophageal Spasm Date:03/01/99ISR Number: 3209539-8Report Type:Expedited (15-DaCompany Report #US_990217971 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Zyprexa (Olanzapine) PS Initial or Prolonged Pancreatitis Haemorrhagic Professional Date:03/01/99ISR Number: 3209542-8Report Type:Expedited (15-DaCompany Report #US_990218016 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affective Disorder Literature Zyprexa (Olanzapine) PS 20MG / 1 DAY Initial or Prolonged Aggression Health Agitation Professional Delusion Elevated Mood Mania Psychotic Disorder 24-Jun-2005 12:19 PM Page: 578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3209546-5Report Type:Expedited (15-DaCompany Report #US_990218064 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glucose Tolerance Health Zyprexa (Olanzapine) PS 10MG / 1 DAY Initial or Prolonged Impaired Professional Prozac C Glycosuria Hyperglycaemia Weight Increased Date:03/01/99ISR Number: 3213935-2Report Type:Periodic Company Report #US_980604555 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Psychotic Disorder Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Date:03/01/99ISR Number: 3213974-1Report Type:Periodic Company Report #US_980606081 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Zyprexa (Olanzapine) PS 30 MG / DAY Initial or Prolonged Intentional Misuse Health Prozac (Fluoxetine Professional Hydrochloride) SS 1 WK Risperdal (Risperidone) C Date:03/01/99ISR Number: 3214152-2Report Type:Periodic Company Report #US_981012006 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acidosis Study Olanzapine PS 10 MG/ HS AT Hospitalization - Dehydration Health BEDTIME Initial or Prolonged Hypotension Professional Fluoxetine Myocardial Infarction (Fluoxetine Pancreatitis Hydrochloride) SS 20 MG/D DAY Pneumonia Prilosec C Respiratory Disorder Levoxyl C Urinary Tract Infection Albuterol C Azmacort C Date:03/01/99ISR Number: 3214153-4Report Type:Periodic Company Report #US_981012012 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/QPM IN Initial or Prolonged Gastritis Health THE EVENING Gastrointestinal Disorder Professional Prozac (Fluoxetine Hydrochloride) SS 40 MG/QAM IN THE MORNING Humulin Nph C Humulin Regular C Aleve C 24-Jun-2005 12:19 PM Page: 579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3214156-XReport Type:Periodic Company Report #US_981012436 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Study Olanzapine PS 15 MG/D DAY Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/D DAY Amaryl C Date:03/01/99ISR Number: 3214161-3Report Type:Periodic Company Report #US_981113703 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Suicide Attempt Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Ativan C Tylenol C Day Pro C Naprosyn C Atenolol C Klonopin C Seroquel C Date:03/01/99ISR Number: 3214164-9Report Type:Periodic Company Report #US_981214128 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Olanzapine PS 10 MG/AT Initial or Prolonged Pneumonia Health BEDTIME AT Professional BEDTIME Prozac (Fluoxetine Hydrochloride) SS 20 MG/IN THE MORNING IN THE MORNING Ativan C Lotensin C Naprosyn C Cimetidine C Date:03/01/99ISR Number: 3214622-7Report Type:Periodic Company Report #US_980706878 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Health Zyprexa (Olanzapine) PS 1 YR Jaundice Professional Prozac (Fluoxetine Liver Function Test Hydrochloride) SS Abnormal Trazodone C Date:03/01/99ISR Number: 3214669-0Report Type:Periodic Company Report #US_980808592 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Paranoia Health (Fluoxetine Professional Hydrochloride) PS Olanzapine SS 24-Jun-2005 12:19 PM Page: 580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3215783-6Report Type:Periodic Company Report #US_980909548 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Study Olanzapine PS 5 MG/HS AT Initial or Prolonged Urinary Tract Infection Health BEDTIME Other Professional Fluoxetine (Fluoxetine Hydrochloride) SS 20 MG /D DAY Ativan(Lorazepam) C Diovan (Valsartan) C Furosemide C Humulin N (Insulin Human Injuection, Isophane) C Humulin N (Insulin Human Injection, Isophane) C Humulin R (Insulin Human) C Humulin R (Insulin Human) C Rezulin (Troglitazone) C Aspirin C Date:03/01/99ISR Number: 3215801-5Report Type:Periodic Company Report #US_980909703 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Pyrexia Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG /DAY Synthroid (Levothyroxine Sodium) C Atenolol C Prilosec (Omeprazole) C Date:03/01/99ISR Number: 3215865-9Report Type:Periodic Company Report #US_980910647 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Hallucination Health Prozac (Fluoxetine Insomnia Professional Hydrochloride) SS Paranoia Mellaril (Thioridazine Hydrochloride) C Date:03/01/99ISR Number: 3216005-2Report Type:Periodic Company Report #US98023499A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Prozac (Fluoxetine Professional Hydrochloride) PS Zyprexa (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3219045-2Report Type:Periodic Company Report #US97073961A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Prozac (Fluorextine Initial or Prolonged Pyrexia Health Hydrochloride) PS 10 MG 1 DAY Professional Zyprexa (Olanzapine) SS 5 MG 1 DAY Tylenol C Lithium C Inderal C Fosamax C Calcium Carbonate C Date:03/01/99ISR Number: 3219876-9Report Type:Periodic Company Report #US_980503657 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 20MG/DAY Olanzapine SS 15MG/AT BEDTIME Motrin C Date:03/01/99ISR Number: 3219882-4Report Type:Periodic Company Report #US_980504135 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10MG/DAY Initial or Prolonged Health Prozac (Fluoxetine Professional Hydrochloride) SS 20MG/DAY Depakote C Ativan C Guaifenesin C Sudafed C Bc Powder C Genora C Vicks Formula 44 C Testosterone Propionate C Date:03/01/99ISR Number: 3429253-3Report Type:Periodic Company Report #US98023544A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Prozac PS Lilly Research Sedation Health Laboratories Div Eli Professional Lilly And Co 20 MG/ 1 DAY Zyprexa (Olanzapine) SS 5 MG/ 1 DAY Lithium C Multivitamin C Vitamin B C Vitamin C C 24-Jun-2005 12:19 PM Page: 582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3429317-4Report Type:Periodic Company Report #US_980707379 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vitreous Disorder Health Prozac PS Lilly Research Professional Laboratories Div Eli Lilly And Co Zyprexa (Olanzapine) SS Date:03/01/99ISR Number: 3429318-6Report Type:Periodic Company Report #US_980707387 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Porphyria Non-Acute Health Prozac PS Lilly Research Professional Laboratories Div Eli Company Lilly And Co Representative Zyprexa (Olanzapine) SS A FEW DAYS DAY Date:03/01/99ISR Number: 3429322-8Report Type:Periodic Company Report #US_980807865 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Prozac PS Lilly Research Nystagmus Professional Laboratories Div Eli Lilly And Co 40 MG/DAY 5 MON Zyprexa (Olanzapine) SS 5 MG/DAY 5 MON Klonopin (Clonazepam) C Genora C Cogentin (Benzatropine Mesilate) C Date:03/01/99ISR Number: 3429630-0Report Type:Periodic Company Report #US98024498A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Foetal Disorder Prozac PS Lilly Research Laboratories Div Eli Lilly And Co Zyprexa (Olanzapine) SS Date:03/01/99ISR Number: 3429908-0Report Type:Periodic Company Report #US97070583A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Prozac PS Lilly Research Laboratories Div Eli Lilly And Co Zyprexa SS Date:03/01/99ISR Number: 3430371-4Report Type:Periodic Company Report #US_981012366 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myasthenic Syndrome Consumer Prozac PS Lilly Research Speech Disorder Laboratories Div Eli 24-Jun-2005 12:19 PM Page: 583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lilly And Co 20 MG/DAY Zyprexa(Olanzapine) SS Eskalith(Lithium Carbonate) C Lipitor(Atorvastatin ) C Aspirin C Date:03/01/99ISR Number: 3430714-1Report Type:Periodic Company Report #US98021267A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Consumer Prozac PS Lilly Research Health Laboratories Div Eli Professional Lilly And Co 10 MG / 1 DAY Zyprexa (Olanzapine) SS 15 MG/ 1 DAY Progesterone C Date:03/01/99ISR Number: 3430918-8Report Type:Periodic Company Report #US98025623A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertonia Consumer Prozac PS Lilly Research Sedation Health Laboratories Div Eli Professional Lilly And Co 80 MG/ 1 DAY 9 YR Zyprexa (Olanzapine) SS 2.5 MG/ 1 DAY 20 DAY Baclofen C Oxybutynin C Spironolactone C Synthroid(Levothyrox ine Sodium) C Diazepam C Klonopin (Clonazepam) C Tylenol (Paracetamol) C Voltaren (Diclofenac Sodium) C Nystatin C Sporanox (Itraconazole) C Nortriptyline C Furosemide C Prednisone C Date:03/01/99ISR Number: 3432212-8Report Type:Periodic Company Report #US98023115A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Consumer Zyprexa (Olanzapine) PS 2.5 MG/ 1 DAY Flatulence Health Prozac (Fluoxetine Professional Hydrochloride) SS 40 MG/ 1 DAY 6 WK Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/99ISR Number: 3218486-7Report Type:Periodic Company Report #JAUSA-35781 Age:64 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Propulsid Professional (Cisapride) , Janssen, PS Janssen ORAL 20 MG 4 DAILY ORAL START DATE ESTIMATED Zyprexa (Olanzapine) SS Depakote C Chronulac C Zantac C Timoptic C Date:03/03/99ISR Number: 3211589-2Report Type:Expedited (15-DaCompany Report #990224-008010805 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Haloperidol PS ORAL 2MG, QD, Pain In Extremity Health ORAL; 4MG, Professional QD, ORAL TABLETS Olanzapine SS ORAL 10MG, QD, ORAL Mirtazapine SS ORAL 15MG, QD, ORAL; 30MG,QD, ORAL Lorazepam SS ORAL 2MG, QD, ORAL Levothyroxine C Buspirone C Pindolol C Date:03/03/99ISR Number: 3211736-2Report Type:Expedited (15-DaCompany Report #9906597 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zoloft Tablets PS ORAL ORAL Initial or Prolonged Drug Level Above Professional Lithobid SS ORAL 600.00 MG Therapeutic TOTAL: DAILY: Feeling Drunk ORAL Nausea Zyprexa SS ORAL ORAL Tremor Benztropine SS ORAL ORAL Wellbutrin C Neurontin C Klonopin C Ambien C Date:03/05/99ISR Number: 3214470-8Report Type:Expedited (15-DaCompany Report #A0082673 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Wellbutrin Tablet PS ORAL ORAL Initial or Prolonged Drug Level Above Professional Lithium Carbonate Therapeutic Other Tablet SS ORAL ORAL Feeling Drunk Olanzapine Tablet SS ORAL ORAL Nausea Benzatropine Tablet SS ORAL ORAL Tremor Gabapentin Tablet SS ORAL ORAL 24-Jun-2005 12:19 PM Page: 585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam Tablet SS ORAL ORAL Zolpidem Tartrate Tablet SS ORAL ORAL Sertraline Hydrochloride Tablet SS ORAL ORAL Date:03/05/99ISR Number: 3214552-0Report Type:Expedited (15-DaCompany Report #JAFIN-43416 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal PS ORAL 8 MG DAILY Initial or Prolonged Neutropenia ORAL Zyprexa (Olanzapine) Tablet SS ORAL 5 MG DAILY ORAL Risperdal (Risperidone) SS ORAL 5 MG DAILY ORAL 4 DAY Zyprexa (Olanzapine) SS ORAL 10 MG DAILY ORAL Diapam (Diazepam) C Date:03/08/99ISR Number: 3214100-5Report Type:Direct Company Report # Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Olanzapine PS 5 MG Q DAY Required Syndrome Levothyroxine C Intervention to Tocopheryl C Prevent Permanent Multivitamin C Impairment/Damage Thiamine C Metronidazole C Acetaminophen C Glyburide C Insulin C Date:03/08/99ISR Number: 3215134-7Report Type:Expedited (15-DaCompany Report #US-981214812 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa (Olanzapine) PS 20 MG/DAY 3 MON Initial or Prolonged Professional Lithium C Klonopin C Inderal C Date:03/08/99ISR Number: 3215136-0Report Type:Expedited (15-DaCompany Report #US-990218275 Age:45 YR Gender:Male I/FU:I Outcome PT Death Alcohol Interaction Blood Alcohol Increased Cholelithiasis Coma Drug Abuser Drug Toxicity Pericarditis Adhesive Pulmonary Congestion 24-Jun-2005 12:19 PM Page: 586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS Professional Date:03/08/99ISR Number: 3215138-4Report Type:Expedited (15-DaCompany Report #EWC990202817 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Marrow Hyperplasia Health Risperdal C Neutropenia Professional Diapam C Viral Infection Date:03/08/99ISR Number: 3215140-2Report Type:Expedited (15-DaCompany Report #US-990218151 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Zyprexa (Olanzapine) PS 4 MON Initial or Prolonged Neutrophil Count Abnormal Professional Depakote C White Blood Cell Disorder Date:03/08/99ISR Number: 3215148-7Report Type:Expedited (15-DaCompany Report #US-990218171 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa (Olanzapine) PS Professional Date:03/08/99ISR Number: 3215153-0Report Type:Expedited (15-DaCompany Report #CA_990200357 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Olanzapine PS 10 MG/1 DAY Initial or Prolonged Gallbladder Pain Study Health Professional Date:03/08/99ISR Number: 3215155-4Report Type:Expedited (15-DaCompany Report #CA_990200359 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 10 MG Initial or Prolonged Neutropenia Health Clozapine C Professional Lithium C Company Representative Date:03/08/99ISR Number: 3215156-6Report Type:Expedited (15-DaCompany Report #DE_990200940 Age:47 YR Gender:Female I/FU:I Outcome PT Other Dermatitis Leukopenia 24-Jun-2005 12:19 PM Page: 587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutropenia Pyrexia Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 25 MG/DAY 10 DAY Health Zolpidem C Professional Trisequens C Dihydergot Retard C Nitrangin Compositum C Date:03/08/99ISR Number: 3215169-4Report Type:Expedited (15-DaCompany Report #US_990218174 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa (Olanzapine) PS Therapeutic Professional Stelazine C Excoriation Zoloft C Hyponatraemia Injury Laboratory Test Abnormal Muscle Haemorrhage Tongue Disorder Vitreous Disorder Date:03/08/99ISR Number: 3215186-4Report Type:Expedited (15-DaCompany Report #GBS990202704 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa (Olanzapine) PS 2.5 MG DAY Initial or Prolonged Aminotransferase Health Chlormethiazole C Increased Professional Digoxin C Blood Alkaline Company Aspirin C Phosphatase Increased Representative Lorazepam C Blood Bilirubin Increased Senna C Jaundice Date:03/08/99ISR Number: 3215189-XReport Type:Expedited (15-DaCompany Report #GBS990202674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Olanzapine PS 10 MG DAY Initial or Prolonged Priapism Health Professional Date:03/08/99ISR Number: 3215191-8Report Type:Expedited (15-DaCompany Report #EWC990202785 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Life-Threatening Hyperkalaemia Health Clomipramine C Ventricular Tachycardia Professional Lithium Carbonate C Other 24-Jun-2005 12:19 PM Page: 588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3215192-XReport Type:Expedited (15-DaCompany Report #EWC990202781 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Jaundice Health Professional Date:03/08/99ISR Number: 3215194-3Report Type:Expedited (15-DaCompany Report #EWC990202809 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Foreign Zyprexa (Olanzapine) PS 30 MG/DAY 23 MON Initial or Prolonged Therapeutic Health Temesta C Professional Date:03/08/99ISR Number: 3215525-4Report Type:Expedited (15-DaCompany Report #US_990218140 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Drug Level Above Other Lithobid C Therapeutic Benzotropine C Feeling Drunk Wellbutrin C Nausea Neurontin C Tremor Klonopin C Ambien C Zoloft C Inderal C Date:03/08/99ISR Number: 3215529-1Report Type:Expedited (15-DaCompany Report #US_990218068 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 6 WK Initial or Prolonged Agitation Health Clozapine C Hyperhidrosis Professional Hypokalaemia Hyponatraemia Leukocytosis Lung Infiltration Mental Impairment Neuroleptic Malignant Syndrome Pneumonia Pyrexia Speech Disorder Date:03/08/99ISR Number: 3215552-7Report Type:Expedited (15-DaCompany Report #US_990218165 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Zyprexa (Olanzapine) PS Bipolar I Disorder Professional Methadone C Condition Aggravated Methylphenidate C Coronary Artery Disease Laboratory Test Abnormal Toxicologic Test Abnormal 24-Jun-2005 12:19 PM Page: 589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3219745-4Report Type:Periodic Company Report #1998UW49777 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Seroquel PS Initial or Prolonged Prolonged Health Olanzapine SS Overdose Professional Divalproex C Date:03/09/99ISR Number: 3215390-5Report Type:Expedited (15-DaCompany Report #US_981214351 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Hospitalization - Myocardial Infarction Professional Sinemet C Initial or Prolonged Palpitations Troponin-T/4.0 C Date:03/09/99ISR Number: 3215393-0Report Type:Expedited (15-DaCompany Report #US_990218064 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa (Olanzapine) PS Initial or Prolonged Glucose Tolerance Professional Prozac (Fluoxetine Impaired Hydrochloride) C Glycosylated Haemoglobin Glucose, Serum/Wnl C Increased Hemoglobin A1c C Polydipsia Polyuria Weight Increased Date:03/09/99ISR Number: 3215395-4Report Type:Expedited (15-DaCompany Report #8-99060-110A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombosis Foreign Tavor PS ORAL 2 MG ONCE Study DAILY ORAL Buspar SS ORAL 15 MG TO 30 MG DAILY ORAL Haldol SS ORAL 2 MG TO 4 MG DAILY ORAL Renergil (Mirtazapine) SS ORAL 15 MG TO 30 MG DAILY ORAL Zyprexa SS ORAL 10 MG DAILY ORAL Levothyroxine C Visken C Date:03/09/99ISR Number: 3215488-1Report Type:Expedited (15-DaCompany Report #US_990116232 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa (Olanzapine) PS Corrected Interval Professional Remeron C Prolonged 24-Jun-2005 12:19 PM Page: 590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/99ISR Number: 3215492-3Report Type:Expedited (15-DaCompany Report #US_980707483 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Ulcer Health Zyprexa (Olanzapine) PS 10 MG/DAY 10 MON Hepatic Steatosis Professional Prolixin Decanoate(Fluphenazi ne Decanoate) C Depakote (Valproate Sodium) C Haldol(Haloperidol) C Artane(Trihexyphenid yl Hydrochloride) C Date:03/09/99ISR Number: 3215571-0Report Type:Expedited (15-DaCompany Report #EWC990102525 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Bradycardia Health Akineton C Initial or Prolonged Cardiac Output Decreased Professional Clopenthixol C Chest Pain Other Circulatory Collapse Dyspnoea Electrocardiogram Abnormal Electrocardiogram Qt Prolonged Hyperhidrosis Nausea Pain Pain In Extremity Pallor Pulmonary Embolism Respiratory Rate Increased Shock Sinus Tachycardia Visual Disturbance Date:03/09/99ISR Number: 3215589-8Report Type:Expedited (15-DaCompany Report #US_981214509 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Professional Depakote C Desipramine C Benadryl C Date:03/10/99ISR Number: 3218242-XReport Type:Direct Company Report # Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Health Olanzapine (Zyprexa) PS ORAL 2.5 MG PO QOD 9 DAY Professional Acetaminophen C Senna C Digoxin C Donazepril C Valproic Acid C 24-Jun-2005 12:19 PM Page: 591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Doxazosin C Warfarin C Metamucil C Date:03/11/99ISR Number: 3217560-9Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Zyprexa PS 10 MG QD Depressed Level Of Consciousness Hypoxic Encephalopathy Metabolic Disorder Muscle Contractions Involuntary Neuroleptic Malignant Syndrome Pyrexia Rhabdomyolysis Status Epilepticus Tachycardia Date:03/11/99ISR Number: 3217594-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine PS ORAL 30 MG DAILY- PO Date:03/11/99ISR Number: 3218581-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Olanzapine PS ORAL 35 MG DAILY Glycosuria PO Date:03/15/99ISR Number: 3218921-4Report Type:Direct Company Report #081134 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Pfizer Zyprexa 10mg (Olanzpine) SS Lilly Date:03/15/99ISR Number: 3221054-4Report Type:Expedited (15-DaCompany Report #EWC990102587 Age:37 YR Gender:Male I/FU:F Outcome PT Death Abdominal Pain Hospitalization - Blood Pressure Initial or Prolonged Fluctuation Colon Cancer Electrolyte Imbalance Intestinal Functional Disorder Large Intestinal Ulcer 24-Jun-2005 12:19 PM Page: 592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Pallor Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS Health Cisordinol-Acutard C Professional Other Date:03/15/99ISR Number: 3221056-8Report Type:Expedited (15-DaCompany Report #EWC990202691 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 10MG / DAY Initial or Prolonged Anaemia Other Largactil C Pyrexia Orfidal C Date:03/15/99ISR Number: 3221057-XReport Type:Expedited (15-DaCompany Report #US_990318428 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Zyprexa (Olanzapine) PS 2 WK Professional Company Representative Date:03/15/99ISR Number: 3221072-6Report Type:Expedited (15-DaCompany Report #GB990102455 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperthyroidism Foreign Zyprexa PS 10 MG DAY Health Lithium C Professional Atenolol C Date:03/15/99ISR Number: 3221106-9Report Type:Expedited (15-DaCompany Report #EWC981001688 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Foreign Zyprexa PS 10 MG/DAY Hospitalization - Bronchopneumonia Health Madopar C Initial or Prolonged Cardiac Arrest Professional Parlodel C Other Electrocardiogram Qt Other Effortil C Prolonged Loss Of Consciousness Myocardial Infarction Ventricular Fibrillation Date:03/15/99ISR Number: 3221139-2Report Type:Expedited (15-DaCompany Report #CA_990200357 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Olanzapine PS 10 MG /1 DAY Initial or Prolonged Pain Study Health Professional 24-Jun-2005 12:19 PM Page: 593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/99ISR Number: 3221146-XReport Type:Expedited (15-DaCompany Report #US_990218359 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acquired Health Zyprexa (Olanzapine) PS 15MG / 1 DAY Initial or Prolonged Tracheo-Oesophageal Professional Depakene C Other Fistula Capoten C Oesophageal Perforation Syncope Date:03/15/99ISR Number: 3221151-3Report Type:Expedited (15-DaCompany Report #US_990318706 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Olanzapine PS 20MG / 1 DAY Initial or Prolonged Drug Interaction Health Leukopenia Professional Neutropenia Schizophrenia Date:03/15/99ISR Number: 3221155-0Report Type:Expedited (15-DaCompany Report #GBS990302780 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa (Olanzapine) PS 1600MG / DAY Initial or Prolonged Confusional State Health Hallucination, Auditory Professional Intentional Misuse Other Loss Of Consciousness Pneumonia Schizophrenia Suicidal Ideation Suicide Attempt Date:03/15/99ISR Number: 3221159-8Report Type:Expedited (15-DaCompany Report #GBS990202645 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa (Olanzapine) PS 1000MG Initial or Prolonged Health Venlafaxine C Professional Company Representative Other Date:03/15/99ISR Number: 3221168-9Report Type:Expedited (15-DaCompany Report #DE_981200696 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa (Olanzapine) PS 12.5 MG/DAY Initial or Prolonged Health Doxepin C Professional Other 24-Jun-2005 12:19 PM Page: 594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/99ISR Number: 3221170-7Report Type:Expedited (15-DaCompany Report #DE_990200877 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Overdose Health Lorazepam C Professional Date:03/15/99ISR Number: 3221251-8Report Type:Expedited (15-DaCompany Report #DE_990200890 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Lipids Increased Health Decentan Liver Function Test Professional (Perphenazine) C Abnormal Neurocil Pancreatic Enzymes (Levomepromazine Increased Maleate) C Pancreatitis Acute Date:03/15/99ISR Number: 3221257-9Report Type:Expedited (15-DaCompany Report #EWC990202778 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Other Flurazepam C Date:03/15/99ISR Number: 3221269-5Report Type:Expedited (15-DaCompany Report #GBS990202674 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Olanzapine PS 10 MG DAY Initial or Prolonged Priapism Health Professional Date:03/15/99ISR Number: 3221273-7Report Type:Expedited (15-DaCompany Report #EWC990102560 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Dermatitis Health Carbamazepine C Haemorrhage Subcutaneous Professional Clomipramine C Leukocytoclastic Temazepam C Vasculitis Lithium C Liver Function Test Sintrom C Abnormal Verapamil C Oedema Pruritus Sedation Thrombin Time Prolonged Date:03/15/99ISR Number: 3221309-3Report Type:Expedited (15-DaCompany Report #EWC990202692 Age:45 YR Gender:Male I/FU:F Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Acute Abdomen Foreign Zyprexa (Olanzapine) PS 15MG/DAY Pulmonary Oedema Health Valproate Sodium C Renal Failure Professional Respiratory Failure Other Vomiting Date:03/22/99ISR Number: 3224457-7Report Type:Expedited (15-DaCompany Report #GBS990202704 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa(Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Liver Function Test Health Chlormethiazole C Abnormal Professional Digoxin C Other Aspirin C Lorazepam C Senna C Date:03/22/99ISR Number: 3224494-2Report Type:Expedited (15-DaCompany Report #EWC990202661 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Aortic Dissection Health Artane(Trihexyphenid Initial or Prolonged Blood Pressure Diastolic Professional yl Hydrochloride) C Increased Other Lactulose C Cardiac Arrest Hydrocortisone C Cardiac Failure Central Venous Pressure Increased Chest Pain Convulsion Electrocardiogram St Segment Elevation Heart Rate Irregular Hyperventilation Malaise Myocardial Infarction Nausea Pallor Ventricular Tachycardia Date:03/23/99ISR Number: 3224613-8Report Type:Expedited (15-DaCompany Report #GBS990302858 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Pain In Extremity Health Paroxetine C Rheumatoid Arthritis Professional Other 24-Jun-2005 12:19 PM Page: 596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/99ISR Number: 3224645-XReport Type:Expedited (15-DaCompany Report #US_990116827 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Hospitalization - Chronic Sinusitis Professional Lorazepam C Initial or Prolonged Coma Other Condition Aggravated Encephalopathy Grand Mal Convulsion Pyrexia Date:03/23/99ISR Number: 3224724-7Report Type:Expedited (15-DaCompany Report #CA_990200356 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Zyprexa (Olanzapine) PS 240 MG Hospitalization - Phosphokinase Increased Health Initial or Prolonged Circulatory Collapse Professional Intentional Misuse Other Liver Function Test Abnormal Pneumonia Pyrexia Suicide Attempt Date:03/23/99ISR Number: 3224757-0Report Type:Expedited (15-DaCompany Report #US_990319000 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Overdose Professional Trazodone C Date:03/23/99ISR Number: 3224759-4Report Type:Expedited (15-DaCompany Report #US_990318865 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Depakote C Hepatocellular Damage Liver Function Test Abnormal Neuroleptic Malignant Syndrome Renal Failure Acute Rhabdomyolysis Date:03/23/99ISR Number: 3224762-4Report Type:Expedited (15-DaCompany Report #US_990318889 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Psychotic Disorder Study Hept-A-Myl C Schizophrenia Health Professional Other 24-Jun-2005 12:19 PM Page: 597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/99ISR Number: 3225884-4Report Type:Direct Company Report # Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Olanzapine 5mg 2-3 Initial or Prolonged Pulmonary Disease Times Daily PS 5MG 2-3 TIMES Convulsion DAILY; APPROX Hyponatraemia 10 MONTH PTA 10 MON Pleural Effusion Phenobarbital 30mg 2 Proteinuria Times Daily SS 30MG 2 TIMES Respiratory Acidosis DAILY; APPROX Respiratory Failure 2 MO PTA 2 MON Date:03/25/99ISR Number: 3226353-8Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fatigue Olanzapine PS ORAL 5MG Q HS PO Intervention to Gout Atenolol C Prevent Permanent Weight Increased Ketoconazole C Impairment/Damage Triamcinolone Acetonide C Capsaicin C Cleocin 300mg/Hydocortisdone 600mg/Propylene Glycol 15ml/Etoh 70% C Indomethacin C Allopurinol C Date:03/25/99ISR Number: 3226593-8Report Type:Expedited (15-DaCompany Report #1999COU0224 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - International Normalised Foreign Coumadin PS ORAL 2 MG QD PO Initial or Prolonged Ratio Decreased Study Olanzapine SS 5 MG QHS UNK Health Atenolol C Professional Digoxin C Enalapril C Date:03/26/99ISR Number: 3227404-7Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Olanzapine PS Initial or Prolonged Dysphasia Fluoxetine SS Doxepin SS Lisinopril C Hctz C Simvastation C Clondypam C Multivit C 24-Jun-2005 12:19 PM Page: 598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/99ISR Number: 3228277-9Report Type:Direct Company Report # Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphagia Health Zyprexa PS Lilly ORAL 2.5 MG Q HS Intervention to Professional PO 17 MON Prevent Permanent Coumadin C Impairment/Damage Bisacodyl Supp C Glyburide C Carbamazepine C Date:03/29/99ISR Number: 3228449-3Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Zyprexa PS Lilly ORAL 10 MG QD ORAL Medication Error Psychotic Disorder Date:03/29/99ISR Number: 3228747-3Report Type:Expedited (15-DaCompany Report #US_990319144 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Neutropenia Professional Depakote C Haldol C Citalopram C Cogentin C Mevacor C Clonazepam C Allopurinol C Trazodone C Synthroid C Date:03/29/99ISR Number: 3228751-5Report Type:Expedited (15-DaCompany Report #US_990319132 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharyngeal Oedema Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Swelling Valium C Date:03/29/99ISR Number: 3228774-6Report Type:Expedited (15-DaCompany Report #US_990319098 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS 10 MG/ 1 DAY 6 MON Professional Company Representative Date:03/29/99ISR Number: 3229220-9Report Type:Expedited (15-DaCompany Report #GBS990302784 Age: Gender:Female I/FU:I Outcome PT Death Condition Aggravated Medication Error Pyrexia 24-Jun-2005 12:19 PM Page: 599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Uterine Inflammation Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa Health (Olanzapine) PS 5 MG DAY Professional Reboxetine C Lithium C Amitriptyline C Co-Beneldopa C Date:03/29/99ISR Number: 3229224-6Report Type:Expedited (15-DaCompany Report #DE_990301002 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa (Olanzapine) PS 10 MG/2 DAY Health Tegretal C Professional Other Date:03/29/99ISR Number: 3229229-5Report Type:Expedited (15-DaCompany Report #GBS990302920 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Foreign Zyprexa (Olanzapine) PS 105 MG DAY Initial or Prolonged Health Professional Other Date:03/29/99ISR Number: 3229232-5Report Type:Expedited (15-DaCompany Report #US_980503740 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Labour Health Zyprexa (Olanzapine) PS 10 MG/ 1 AT Initial or Prolonged Accidental Exposure Professional BEDTIME 1 YR Caesarean Section Thorazine C Date:03/29/99ISR Number: 3229237-4Report Type:Expedited (15-DaCompany Report #US_990319292 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antiphospholipid Syndrome Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Benign Intracranial Professional Hypertension Deep Vein Thrombosis Lupus-Like Syndrome Papilloedema Date:03/29/99ISR Number: 3229260-XReport Type:Expedited (15-DaCompany Report #DE-990200877 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Overdose Health Lorazepam C Professional Other 24-Jun-2005 12:19 PM Page: 600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/99ISR Number: 3229261-1Report Type:Expedited (15-DaCompany Report #US-990217714 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Oesophageal Carcinoma Professional Oesophageal Spasm Throat Cancer Date:03/29/99ISR Number: 3229291-XReport Type:Expedited (15-DaCompany Report #DE_980700236 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Leukopenia Health Phenothiazine C Neutropenia Professional Neurocil C Pharyngitis Decentan C Pyrexia Paspertin C Sab Simplex C Date:03/31/99ISR Number: 3230929-1Report Type:Expedited (15-DaCompany Report #A0086505 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Wellbutrin Tablet- Initial or Prolonged Grand Mal Convulsion Professional Controlled Release PS ORAL 150 MG THREE Hallucination Company TIMES PER DAY Illusion Representative ORAL Memory Impairment Olanzapine Sedation (Formulation Unknown) SS 10 MG PER DAY Fluvoxamine Maleate C Lithium Salt C Propranolol Hydrochloride C Lorazepam C Thyroxine Sodium C Date:04/01/99ISR Number: 3231367-8Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erection Increased Zyprexa PS ORAL 10MG PO Q HS Pain Haldol C Cogentin C Date:04/01/99ISR Number: 3232039-6Report Type:Periodic Company Report #7397542 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Abbott - Depakote PS ORAL 1.500 GM PO Professional QD Company Zyprexa SS ORAL PO QD Representative Zyprexa C Neurontin C 24-Jun-2005 12:19 PM Page: 601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/99ISR Number: 3232345-5Report Type:Periodic Company Report #7397863 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Depakote PS ORAL PO Professional Zyprexa SS Other Date:04/01/99ISR Number: 3232366-2Report Type:Periodic Company Report #7396258 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Health Abbott-Depakote PS ORAL 2.5000 GM PO Dehydrogenase Increased Professional QD Drug Interaction Other Zyprexa SS PO QD Electrocardiogram Ibuprofen C Abnormal Date:04/01/99ISR Number: 3232367-4Report Type:Periodic Company Report #7396259 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Abbott-Depakote PS ORAL 2.500 GM PO Electrocardiogram Professional QD Abnormal Other Zyprexa SS ORAL 7.500 MG PO Oedema Peripheral QD Anafranil C Pyridoxine C Isoniazid C Ibuprofen C Vitamin B6 C Date:04/05/99ISR Number: 3232882-3Report Type:Expedited (15-DaCompany Report #AU_990300504 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa (Olanzapine) PS 300 MG/DAY Initial or Prolonged Suicide Attempt Health Mao Inhibitor C Professional Date:04/05/99ISR Number: 3232884-7Report Type:Expedited (15-DaCompany Report #DE_990301024 Age:90 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa (Olanzapine) PS 5 MG Myocardial Infarction Health Tavor C Oedema Peripheral Professional Pulmonary Oedema Sedation Date:04/05/99ISR Number: 3232885-9Report Type:Expedited (15-DaCompany Report #DE_990301035 Age:83 YR Gender:Female I/FU:I Outcome Death Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS Pneumonia Health Professional Date:04/05/99ISR Number: 3232888-4Report Type:Expedited (15-DaCompany Report #GBS990302918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aplastic Anaemia Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Health Thioridazine C Professional Trifluoperazine C Date:04/05/99ISR Number: 3233024-0Report Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Zyprexa 5 Mg PS 5 MG AT 1800 Klonopin SS Q 0800 AND 2100 Date:04/05/99ISR Number: 3233074-4Report Type:Expedited (15-DaCompany Report #DE_990301002 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa PS 10MG/2 DAY Health Tegretal C Professional ... C Other ... C Date:04/05/99ISR Number: 3233081-1Report Type:Expedited (15-DaCompany Report #9911521 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Navane Capsules PS ORAL 10.00 MG Initial or Prolonged Disturbance In Attention TOTAL:DAILY:O Drug Ineffective RAL Zoloft SS ORAL ORAL Zyprexa SS Risperdal SS Date:04/05/99ISR Number: 3233087-2Report Type:Expedited (15-DaCompany Report #US_990319671 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Health Zyprexa PS 10MG/1 DAY Initial or Prolonged Tongue Discolouration Professional Navane C Lithium C Lamactil C Cogentin C 24-Jun-2005 12:19 PM Page: 603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/99ISR Number: 3233088-4Report Type:Expedited (15-DaCompany Report #GBS990302924 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amyotrophic Lateral Foreign Zyprexa PS 15MG/DAY Initial or Prolonged Sclerosis Health Aspirin C Dysphagia Professional Isosorbide Mutism Other Mononitrate C Trazodone C Atenolol C Procyclidine C Propantheline Bromide C Hyoscine Hydrobromide C Date:04/06/99ISR Number: 3232965-8Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa PS 20, NITE Professional Effexor C Colace C Date:04/06/99ISR Number: 3232966-XReport Type:Direct Company Report # Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Health Zyprexa PS 10, BID 2 MON Professional Amitriptyline C Gemfibrozil C Zantac C Buspar C Ativan C Serzone C Synthroid C Date:04/06/99ISR Number: 3232967-1Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa PS 10 AT HS 3 YR Professional Date:04/07/99ISR Number: 3233963-0Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Zyprexa PS ORAL 10MG PO Q HS Haldol C Cogentin C 24-Jun-2005 12:19 PM Page: 604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/99ISR Number: 3234272-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec (Cetirizine Hydrochloride) PS Pfizer Zyprexa (Olanzapine) SS Lilly Date:04/08/99ISR Number: 3237392-5Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Zyrtec Tablets PS ORAL 5MG PO QD Dysphoria Zyprexa Tablet SS ORAL 5MG PO QD Medication Error Date:04/12/99ISR Number: 3237867-9Report Type:Expedited (15-DaCompany Report #US_990319902 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Barbiturates Positive Health Zyprexa PS 75 MG Initial or Prolonged Coma Professional Clonopin C Miosis Company Prozac C Overdose Representative Ritalin C Pneumonia Aspiration Date:04/12/99ISR Number: 3237937-5Report Type:Expedited (15-DaCompany Report #GBS990302784 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa (Olanzapine) PS 5 MG DAY Pyrexia Health Reboxetine C Urinary Tract Infection Professional Date:04/12/99ISR Number: 3237940-5Report Type:Expedited (15-DaCompany Report #CA_990200357 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Olanzapine PS 10 MG 1 DAY Initial or Prolonged Study Health Professional Date:04/12/99ISR Number: 3237952-1Report Type:Expedited (15-DaCompany Report #DE_990401059 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Hodgkin'S Lymphoma Foreign Zyprexa (Olanzapine) PS 3 YR Health Professional 24-Jun-2005 12:19 PM Page: 605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/99ISR Number: 3238035-7Report Type:Expedited (15-DaCompany Report #9906989 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Galactorrhoea Health Zoloft Tablets PS ORAL 150.00MG Intervention to Gynaecomastia Professional TOTAL DAILY Prevent Permanent Thyroxine Decreased ORAL Impairment/Damage Zyprexa SS ORAL 10.00MG TOTAL DAILY ORAL Date:04/12/99ISR Number: 3238065-5Report Type:Expedited (15-DaCompany Report #US_990318865 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Phosphokinase Increased Professional Depakote C Depressed Level Of Consciousness Hepatocellular Damage Hypertension Leukocytosis Liver Function Test Abnormal Renal Failure Acute Rhabdomyolysis Tachycardia Tachypnoea Date:04/12/99ISR Number: 3238067-9Report Type:Expedited (15-DaCompany Report #US_990420242 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperphagia Health Zyprexa (Olanzapine) PS Hospitalization - Polydipsia Professional Initial or Prolonged Polyuria Company Representative Date:04/12/99ISR Number: 3238069-2Report Type:Expedited (15-DaCompany Report #GBS990302966 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Foreign Zyprexa (Olanzapine) PS Health Professional Date:04/12/99ISR Number: 3238071-0Report Type:Expedited (15-DaCompany Report #DE_990301045 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Galactorrhoea Health Promethazine Orthostatic Hypotension Professional Hydrochloride C Other 24-Jun-2005 12:19 PM Page: 606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/99ISR Number: 3238072-2Report Type:Expedited (15-DaCompany Report #US_990420146 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decreased Appetite Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Myocardial Infarction Professional Ecotrin C Captopril C K-Dur C Lasix C Date:04/12/99ISR Number: 3238080-1Report Type:Expedited (15-DaCompany Report #GBS990302918 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa(Olanzapine) PS 40 MG/DAY Initial or Prolonged Anisocytosis Health Thioridazine C Haemorrhage Professional Trifluoperazine C Leukoerythroblastic Other Diazepam C Anaemia Polychromasia Punctate Basophilia Date:04/12/99ISR Number: 3238082-5Report Type:Expedited (15-DaCompany Report #US_980402295 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Zyprexa(Olanzapine) PS 10 MG/1 DAY Health Paxil(Paroxetine Professional Hydrochloride) C Company Synthroid(Levothyrox Representative ine Sodium) C Cytomel(Liothyronine Sodium) C Date:04/12/99ISR Number: 3238114-4Report Type:Expedited (15-DaCompany Report #DE_990301048 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Health Haldol C Professional Remotiv C Other Date:04/14/99ISR Number: 3239859-2Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Thyroid Stimulating Health Olansapine Zyprexa PS Eli Lilly ORAL 10 MG HS PO Intervention to Hormone Increased Professional Pepcid C Prevent Permanent Body Temperature Vi Day 1/N With Iron C Impairment/Damage Decreased Naltrexone C Feeling Cold 24-Jun-2005 12:19 PM Page: 607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/99ISR Number: 3239861-0Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Thyroid Stimulating Health Olansapine PS Eli Lilly ORAL 15 MG HS PO Intervention to Hormone Increased Professional Lorazepam C Prevent Permanent Wellbutrin Sr C Impairment/Damage Date:04/14/99ISR Number: 3239960-3Report Type:Expedited (15-DaCompany Report #USA004722 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Meridia PS ORAL 10 MG OD PO Hepatic Steatosis Professional Olanzapine SS Neuroleptic Malignant Other Syndrome Date:04/19/99ISR Number: 3242414-1Report Type:Expedited (15-DaCompany Report #GBS990302858 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Pain In Extremity Health Paroxetine C Rheumatoid Arthritis Professional Loratidine C Other Date:04/19/99ISR Number: 3242483-9Report Type:Expedited (15-DaCompany Report #US_990420242 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Hospitalization - Diabetes Mellitus Professional Initial or Prolonged Diabetic Coma Company Hyperphagia Representative Malaise Polydipsia Polyuria Urinary Incontinence Date:04/19/99ISR Number: 3242485-2Report Type:Expedited (15-DaCompany Report #US_990319098 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Company Representative Date:04/19/99ISR Number: 3242568-7Report Type:Expedited (15-DaCompany Report #GBS990403007 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Venous Pressure Jugular Health Paroxetine C Increased Professional 24-Jun-2005 12:19 PM Page: 608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/99ISR Number: 3242569-9Report Type:Expedited (15-DaCompany Report #GBS990402992 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa (Olanzapine) PS 2.5 MG DAY Initial or Prolonged Confusional State Health Citalopram C Fatigue Professional Joint Stiffness Other Date:04/19/99ISR Number: 3242630-9Report Type:Expedited (15-DaCompany Report #DE_981200743 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Infiltration Foreign Zyprexa (Olanzapine) PS 10 MG 8 DAY Hospitalization - Pneumonia Aspiration Health Madopar C Initial or Prolonged Pyrexia Professional Parkotil C Tachycardia Motilium C Prostatic Medication C Eunerpan C Date:04/19/99ISR Number: 3242633-4Report Type:Expedited (15-DaCompany Report #GBT990400134 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa (Olanzapine) PS 20 MG DAY Initial or Prolonged Delusion Study Drug Effect Decreased Health Drug Ineffective Professional Hallucination Other Injury Mental Impairment Psychotic Disorder Date:04/19/99ISR Number: 3242634-6Report Type:Expedited (15-DaCompany Report #GBS990403031 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Prolonged Health Malaise Professional Date:04/19/99ISR Number: 3242790-XReport Type:Expedited (15-DaCompany Report #CA_990200359 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Neutropenia Health Clozapine C Professional Lithium C Company Representative Date:04/21/99ISR Number: 3244315-1Report Type:Expedited (15-DaCompany Report #EWC990403151 Age: Gender:Male I/FU:I Outcome PT Report Source Other Mania Foreign Health 24-Jun-2005 12:19 PM Page: 609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS UNKNOWN 10MG / DAY Date:04/22/99ISR Number: 3244673-8Report Type:Direct Company Report # Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Zyprexa PS ORAL 2.5MG QD PO Intervention to Increased Diltiazem C Prevent Permanent Aspartate Ladilosec C Impairment/Damage Aminotransferase Oscal C Increased Asa C Blood Bilirubin Increased Weight Decreased Date:04/26/99ISR Number: 3246950-3Report Type:Expedited (15-DaCompany Report #EWC990403153 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Positive Health Risperdal C Blood Alkaline Professional Klorproman C Phosphatase Increased Other Orsanil C Blood Calcium Decreased Cloxan C C-Reactive Protein Increased Pyrexia Systemic Lupus Erythematosus White Blood Cell Count Increased Date:04/26/99ISR Number: 3246963-1Report Type:Expedited (15-DaCompany Report #US_990420509 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY 2 DAY Health Methyldopa C Professional Date:04/26/99ISR Number: 3246965-5Report Type:Expedited (15-DaCompany Report #EWC990403087 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/99ISR Number: 3246966-7Report Type:Expedited (15-DaCompany Report #EWC990403173 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Pyrexia Health Carbamazepine C Professional Tranxene Other (Clorazepate Dipotassium) C Date:04/26/99ISR Number: 3247217-XReport Type:Expedited (15-DaCompany Report #US_990420775 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa (Olanzapine) PS Professional Company Representative Date:04/26/99ISR Number: 3247219-3Report Type:Expedited (15-DaCompany Report #GBS990302918 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Initial or Prolonged Anisocytosis Health Thioridazine C Blood Folate Decreased Professional Trifluoperazine C Gastrointestinal Other Diazepam C Haemorrhage Haemoglobin Decreased Overdose Polychromasia Serum Ferritin Decreased Vitamin B12 Deficiency Date:04/26/99ISR Number: 3247221-1Report Type:Expedited (15-DaCompany Report #US_990319292 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Intracranial Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Hypertension Professional Zetar C Deep Vein Thrombosis Hydrocortisone C Lupus-Like Syndrome Merieux Flu Vaccine C Papilloedema Date:04/26/99ISR Number: 3247222-3Report Type:Expedited (15-DaCompany Report #CA_990200359 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Health Clozapine C Professional Lithium C Company Synthroid C Representative Risperidone C Other Imipramine C Zestoretic C Epival C 24-Jun-2005 12:19 PM Page: 611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/99ISR Number: 3247291-0Report Type:Expedited (15-DaCompany Report #US_990420849 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Albumin Decreased Health Zyprexa (Olanzapine) PS Blood Creatine Professional Phosphokinase Increased Blood Creatinine Increased Hepatic Failure Liver Function Test Abnormal Overdose Renal Failure Date:04/26/99ISR Number: 3247296-XReport Type:Expedited (15-DaCompany Report #US_990420854 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Zyprexa (Olanzapine) PS Initial or Prolonged Prolonged Professional Fluvoxamine C Syncope Company Trazodone C Representative Date:04/26/99ISR Number: 3247300-9Report Type:Expedited (15-DaCompany Report #US_990420844 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Lithium C Company Wellbutrin C Representative Date:04/26/99ISR Number: 3247304-6Report Type:Expedited (15-DaCompany Report #US_990420722 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Zyprexa (Olanzapine) PS 25 MG/1 DAY Initial or Prolonged Distress Syndrome Professional Effexor C Other Oedema Lithium C Oedema Peripheral Depakote C Pulmonary Oedema Lorazepam C Weight Increased Date:04/26/99ISR Number: 3247307-1Report Type:Expedited (15-DaCompany Report #US_990420767 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oedema Peripheral Health Zyprexa (Olanzapine) PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/99ISR Number: 3247310-1Report Type:Expedited (15-DaCompany Report #US_990420630 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 15 MG/1 AT Professional BEDTIME Quetiapine Fumarate C Wellbutrin C Restoril C Date:04/26/99ISR Number: 3247313-7Report Type:Expedited (15-DaCompany Report #US_990420528 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa (Olanzapine) PS 5 MG/3 DAY Initial or Prolonged Consciousness Professional Phenobarbital C Epilepsy Other Albuterol C Hyponatraemia Atrovent C Metabolic Acidosis Pleural Effusion Pneumonia Polydipsia Proteinuria Respiratory Acidosis Respiratory Failure Date:04/26/99ISR Number: 3247317-4Report Type:Expedited (15-DaCompany Report #EWC990403089 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Dyspnoea Health Nozinan C Face Oedema Professional Haldol C Pruritus Company Representative Date:04/26/99ISR Number: 3250101-9Report Type:Periodic Company Report #A0083747 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Wellbutrin Professional Tablet-Controlled Company Release PS ORAL ORAL 3 WK Representative Olanzapine (Formulation Unknown) SS Date:04/29/99ISR Number: 3249897-1Report Type:Expedited (15-DaCompany Report #DEU001592 Age:65 YR Gender:Female I/FU:I Outcome PT Death Agitation Atrial Fibrillation Cardiomegaly Condition Aggravated Conduction Disorder Delirium Hepatic Steatosis 24-Jun-2005 12:19 PM Page: 613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Myocardial Infarction Report Source Product Role Manufacturer Route Dose Duration Pulmonary Oedema Foreign Isoptin PS ORAL 80 MG DAILY PO Zyprexa SS ORAL 20 MG DAILY PO Lanacrist C Propavan C Temesta C Oxascand C Imovane C Date:04/30/99ISR Number: 3255670-0Report Type:Periodic Company Report #US_990318569 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 10 DAY Professional Prozac (Fluoxetine Hydrochloride) SS 80 MG/1 DAY Trazodone C Date:04/30/99ISR Number: 3255673-6Report Type:Periodic Company Report #US_990318604 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 15 MG/1 DAY Initial or Prolonged Health Professional Date:04/30/99ISR Number: 3255675-XReport Type:Periodic Company Report #US_990318648 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Study Olanzapine PS 1 DSG FORM/2 Initial or Prolonged Health DAY Professional Placebo SS 2 DSG FORM/1 AT BEDTIME Albuterol C Ipratropium C Date:04/30/99ISR Number: 3255676-1Report Type:Periodic Company Report #US_990318742 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 20 MG/1 IN Initial or Prolonged Health THE MORNING Professional Date:04/30/99ISR Number: 3255692-XReport Type:Periodic Company Report #US_990318749 Age:37 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Intentional Misuse Sedation 24-Jun-2005 12:19 PM Page: 614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 400 MG DAY Professional Prozac (Fluoxetine Company Hydrochloride) SS 20 MG/1 DAY Representative Date:04/30/99ISR Number: 3255694-3Report Type:Periodic Company Report #US_990318828 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Health Prozac (Fluoxetine Professional Hydrochloride) SS Date:04/30/99ISR Number: 3255696-7Report Type:Periodic Company Report #US_990318963 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 3 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY Diazepam C Sertraline C Valproate Semisodium C Colace C Ranitidine C Famotidine C Lorazepam C Date:04/30/99ISR Number: 3255706-7Report Type:Periodic Company Report #US_990319012 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 10 MG / 1 DAY Initial or Prolonged Health Depakote C Professional Proventil C Depo Provera C Date:04/30/99ISR Number: 3255707-9Report Type:Periodic Company Report #US_990319146 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 7.5 MG DAY Health Effexor C Professional Bisacodyl C Date:04/30/99ISR Number: 3255708-0Report Type:Periodic Company Report #US_990319151 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Leukocytosis Professional Zoloft C Tachycardia 24-Jun-2005 12:19 PM Page: 615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255710-9Report Type:Periodic Company Report #US_990319171 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Olanzapine PS 2 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Vasotec C Aspirin C Lanoxin C Imdur C Date:04/30/99ISR Number: 3255711-0Report Type:Periodic Company Report #US_990319217 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 590 MG DAY Initial or Prolonged Intentional Misuse Professional Suicide Attempt Company Representative Date:04/30/99ISR Number: 3255712-2Report Type:Periodic Company Report #US_990319225 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypovolaemia Study Zyprexa (Olanzapine) PS 2.5 MG/1 AT Initial or Prolonged Syncope Health BEDTIME Professional Prozac C Furosemide C Lipitor C Ranitidine C Miconazole Nitrate C Insulin Human C Date:04/30/99ISR Number: 3255713-4Report Type:Periodic Company Report #US_990319231 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Zyprexa (Olanzapine) PS Dyskinesia Phenytoin C Grand Mal Convulsion Masked Facies Date:04/30/99ISR Number: 3255716-XReport Type:Periodic Company Report #US_990319249 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 1 DSG FORM/1 IN THE MORNING Olanzapine SS 3 DSG FORM/1 IN THE EVENING 24-Jun-2005 12:19 PM Page: 616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255718-3Report Type:Periodic Company Report #US_990319261 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Study Zyprexa PS 10 MG / 1 AT Health BEDTIME Professional Moban (Molindone) SS 25 MG/2 DAY Depakote C Prozac C Ativan C Zestril C Flonase C Albuterol C Date:04/30/99ISR Number: 3255720-1Report Type:Periodic Company Report #US_990319462 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Consumer Zyprexa (Olanzapine) PS 5 MG/ 3 DAY Initial or Prolonged Pyrexia Health Luvox C Professional Lithium C Lamictal C Date:04/30/99ISR Number: 3255722-5Report Type:Periodic Company Report #US_990319665 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Olanzapine PS 20 MG Initial or Prolonged Health Ativan C Professional Date:04/30/99ISR Number: 3255724-9Report Type:Periodic Company Report #US_990319725 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Zyprexa (Olanzapine) PS 2.5 MG/2 DAY Initial or Prolonged Pyrexia Professional Haldol C Stupor Creatine Phosphokinase C Date:04/30/99ISR Number: 3255725-0Report Type:Periodic Company Report #US_990319800 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG/1 IN Initial or Prolonged Health THE MORNING Professional Date:04/30/99ISR Number: 3255727-4Report Type:Periodic Company Report #US_990319808 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Depakote C Benztropine C Sudafed C 24-Jun-2005 12:19 PM Page: 617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255729-8Report Type:Periodic Company Report #US_990319820 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 3 DSG FORM/ 1 Initial or Prolonged Psychotic Disorder Health DAY Thinking Abnormal Professional Placebo SS 2 DSG FORM/ 1 DAY Date:04/30/99ISR Number: 3255730-4Report Type:Periodic Company Report #US_990319877 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS 15 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Clonazepam C Alprazolam C Aluminium C Casanthranol C Fluoxetine C Ibuprofen C Kaolin/Pectin C Milk Of Magnesia C Nafazodone C Lorazepam C Date:04/30/99ISR Number: 3255732-8Report Type:Periodic Company Report #US_990319943 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 5 MG /1 AT Initial or Prolonged Professional BEDTIME Company Representative Date:04/30/99ISR Number: 3255735-3Report Type:Periodic Company Report #US97065620A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY 3 MON Initial or Prolonged Diabetic Ketoacidosis Professional Hyperglycaemia Company Representative Date:04/30/99ISR Number: 3255748-1Report Type:Periodic Company Report #US_981012545 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5 MG/D DAY Initial or Prolonged Health Bentyl C Professional 24-Jun-2005 12:19 PM Page: 618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255749-3Report Type:Periodic Company Report #US_981112680 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Study Olanzapine PS 15 MG/ HS AT Life-Threatening Health BEDTIME Hospitalization - Professional Lotensin C Initial or Prolonged Glucotrol C Aspirin C Ibuprofen C Date:04/30/99ISR Number: 3255750-XReport Type:Periodic Company Report #US_981113065 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG/HS AT Initial or Prolonged Health BEDTIME Professional Placebo SS Lorazepam C Divalproex Sodium C Benztropine C Diphenhydramine C Fluphenazine C Fluphenazine Decanote C Date:04/30/99ISR Number: 3255751-1Report Type:Periodic Company Report #US_981113074 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Insomnia Health Placebo SS Professional Hydroxyzine C Trazodone C Ativan C Hydrocholorothiazide C Olanzapine C Divalproex Sodium C Multivitamins C Lorazepam C Verapamil C Date:04/30/99ISR Number: 3255752-3Report Type:Periodic Company Report #US_981113076 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG/D DAY Initial or Prolonged Hallucination Health Placebo SS Professional Zestril C Prolixin C Cogentin C Date:04/30/99ISR Number: 3255753-5Report Type:Periodic Company Report #US_981113348 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Overdose Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Olanzapine PS 5 MG/D DAY Lithium C Prozac C Restoril C Date:04/30/99ISR Number: 3255754-7Report Type:Periodic Company Report #US_981113449 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Study Olanzapine PS 5 MG/QHS AT Initial or Prolonged Health BEDTIME Professional Depakote C Propulsid C Prevacid C St. John'S Wort C Date:04/30/99ISR Number: 3255755-9Report Type:Periodic Company Report #US_981113872 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Study Olanzapine PS 5 MG/1 AT Life-Threatening Nervousness Health BEDTIME Hospitalization - Pneumonia Professional Buspirone C Initial or Prolonged Thinking Abnormal Docusate Sodium C Urinary Incontinence Psyllium C Ketoconazole C Paroxetine C Milk Of Magnesia C Date:04/30/99ISR Number: 3255756-0Report Type:Periodic Company Report #US_981214028 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Citalopram C Other Plaquenil C Date:04/30/99ISR Number: 3255757-2Report Type:Periodic Company Report #US_981214128 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Olanzapine PS 10 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Prozac (Fluoxetine Hydrochloride) SS 20 MG/ 1 IN THE MORNING Ativan C Lotensin C Naprosyn C Cimetidine C 24-Jun-2005 12:19 PM Page: 620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255758-4Report Type:Periodic Company Report #US_981214302 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS Initial or Prolonged Overdose Professional Lorazepam C Suicide Attempt Company Representative Date:04/30/99ISR Number: 3255759-6Report Type:Periodic Company Report #US_981214354 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Health Zyprexa (Olanzapine) PS Professional Company Representative Date:04/30/99ISR Number: 3255760-2Report Type:Periodic Company Report #US_981214423 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 4 DSG FORM/ Initial or Prolonged Health AT BEDTIME AT Professional BEDTIME Placebo SS 1 DSG FORM/ MORNING AND BEDTIME DAY Haldol C Cogentin C Date:04/30/99ISR Number: 3255761-4Report Type:Periodic Company Report #US_981214506 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Health Zyprexa (Olanzapine) PS 2.5 MG/ 1 DAY Initial or Prolonged Laboratory Test Abnormal Professional Clindamycin C Stupor Fragmin C Thinking Abnormal Albuterol C Atrovent C Levaquin C Date:04/30/99ISR Number: 3255762-6Report Type:Periodic Company Report #US_981214701 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/DAILY Initial or Prolonged Health DAY Professional Placebo SS 2 MG/DAILY DAY Lisinopril C 24-Jun-2005 12:19 PM Page: 621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255763-8Report Type:Periodic Company Report #US_981214718 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG Initial or Prolonged Health Professional Date:04/30/99ISR Number: 3255764-XReport Type:Periodic Company Report #US_981214970 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Study Olanzapine PS 10 MG/DAILY Initial or Prolonged Hyponatraemia Health DAY Hypothyroidism Professional Placebo SS Pericardial Effusion Pleural Effusion Date:04/30/99ISR Number: 3255765-1Report Type:Periodic Company Report #US_981215222 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS 10 MG/ 1 DAY Initial or Prolonged Health Lanoxin C Professional Cardura C Allopurinol C Aspirin C Theragan-M C Atrovent C Furosemide C K-Dur C Date:04/30/99ISR Number: 3255766-3Report Type:Periodic Company Report #US_981215243 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS Initial or Prolonged Hallucination Health Placebo SS 1 DSG FORM/ Professional 2 DAY Didanosine C Lamivudine C Zidovudine C Trazodone C Combivir C Nelfinavir C Cimetidine C Multivitamins C Zoloft C Haldol C Date:04/30/99ISR Number: 3255767-5Report Type:Periodic Company Report #US_981215247 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 15 MG/ DAY Initial or Prolonged Health Lithium C Professional Prozac C Restoril C 24-Jun-2005 12:19 PM Page: 622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255820-6Report Type:Periodic Company Report #US98023580A Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa (Olanzapine) PS 2.5 MG/1 AT Hospitalization - Sepsis Health BEDTIME Initial or Prolonged Professional Zantac (Ranitidine Hydrochloride) C Aspirin (Acetylsalicylic Acid) C Vastec (Enalapril Maleate) C Insulin C Sinemet C Multivitamin C Rocephin (Ceftriaxone Sodium) C Tylenol (Paracetamol) C Tylenol W/Codeine No. 3 C Restoril (Temazepam) C Date:04/30/99ISR Number: 3255821-8Report Type:Periodic Company Report #US_980401419 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Health Synthroid Professional (Levothyroxine Sodium) C Multivitamins C Senokot (Senna Fruit) C Axid (Nizatidine) C Artificial Tears C Ferrous Sulfate C Date:04/30/99ISR Number: 3255822-XReport Type:Periodic Company Report #US_980401803 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Mania Health Ativan (Lorazepam) C Professional Lithium C Benadryl (Diphenhydramine Hydrochloride) C Date:04/30/99ISR Number: 3255823-1Report Type:Periodic Company Report #US_980402436 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Study Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Initial or Prolonged Sepsis Health Metamucil (Psyllium Professional Hydrophilic Mucilloid) C Tylenol 24-Jun-2005 12:19 PM Page: 623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paracetamol) C Colace (Docusate Sodium) C Ditropan (Oxybutynin) C Date:04/30/99ISR Number: 3255824-3Report Type:Periodic Company Report #US_980503657 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 20 MG / DAY Olanzapine SS 15 MG/AT BEDTIME Motrin (Ibuprofen) C Date:04/30/99ISR Number: 3255825-5Report Type:Periodic Company Report #US_980504178 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Study Olanzapine PS 10 MG/ AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Deponit (Glyceryl Trinitrate) C Ferrous Sulfate C Glyburide C Carbamazepine C Trazodone C Zoloft (Sertraline Hydrochloride) C Date:04/30/99ISR Number: 3255826-7Report Type:Periodic Company Report #US_980604858 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa (Olanzapine) PS 10 MG/AT Initial or Prolonged Apathy Other BEDTIME Epistaxis Phenylpropanolamine Hallucination W/Guaifenesin C Hostility Tessalon Perle Influenza Like Illness (Benzonatate) C Muscle Twitching Septra Ds C Personality Disorder Tinnitus Weight Decreased Weight Increased Date:04/30/99ISR Number: 3255827-9Report Type:Periodic Company Report #US_98605665 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Olanzapine PS 7.5 MG/D DAY Initial or Prolonged Bradycardia Health Lasix (Furosemide) C Cardiac Failure Professional Vasotec (Enalapril Congestive Maleate) C Toprol Xl (Metoprolol 24-Jun-2005 12:19 PM Page: 624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Succinate) C Potassium Chloride C Synthroid (Levothyroxine Sodium) C Multivitamin C Lactulose C Acetylsalicylic Acid C Lortab C Date:04/30/99ISR Number: 3255828-0Report Type:Periodic Company Report #US_980605949 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Study Olanzapine PS 5 MG /BEDTIME Hospitalization - Syncope Health DAY Initial or Prolonged Professional Haldol (Haloperidol) C Trazodone C Synthroid (Levothyroxine Sodium) C Date:04/30/99ISR Number: 3255829-2Report Type:Periodic Company Report #US_980808791 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Olanzapine PS 2 DS FORM/ 1 Initial or Prolonged Dehydration Health AT BEDTIME Professional Placebo SS UNK Amlodipine C Cimetidine C Folic Acid C Thiamine C Multivitamin C Chlordiazepoxide C Date:04/30/99ISR Number: 3255830-9Report Type:Periodic Company Report #US_980808887 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG DAY Initial or Prolonged Hallucination Health Placebo SS 2 MG DAY Insomnia Professional Lorazepam C Schizophreniform Disorder Date:04/30/99ISR Number: 3255831-0Report Type:Periodic Company Report #US_980910237 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa (Olanzapine) PS UNK Initial or Prolonged Hyperglycaemia Professional Lithium Carbonate C Other 24-Jun-2005 12:19 PM Page: 625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255832-2Report Type:Periodic Company Report #US_980910655 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/D DAY Initial or Prolonged Dystonia Health Placebo SS 2 MG/D DAY Vomiting Professional Pyridoxine C Weight Decreased Glyburide C Percocet C Ativan (Lorazepam) C Lisinopril C Isoniazid C Acetaminophen C Date:04/30/99ISR Number: 3255833-4Report Type:Periodic Company Report #US_981011212 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 40 MG/D DAY Initial or Prolonged Health Placebo SS 40 MG/D DAY Professional Zantac (Ranitidine Hydrochloride) C Premarin (Estrogens Conjugated) C Tenoretic C Arthrotec C Date:04/30/99ISR Number: 3255834-6Report Type:Periodic Company Report #US_981011638 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 20 MG / D DAY Initial or Prolonged Overdose Health Professional Date:04/30/99ISR Number: 3255835-8Report Type:Periodic Company Report #US_981011786 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Study Olanzapine PS 10 MG/D DAY Dementia Alzheimer'S Type Health Lasix (Furosemide) C Professional Zyprexa (Olanzapine) C Alece (Naproxen Sodium) C Date:04/30/99ISR Number: 3255836-XReport Type:Periodic Company Report #US_981012012 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/QPM IN Initial or Prolonged Gastritis Health THE EVENING Gastrointestinal Disorder Professional Prozac (Fluoxetine Lung Disorder Hydrochloride) SS 40 MG / QAM IN THE MORNING Humulin Nph (Insulin Human Injection, Isophane) C 24-Jun-2005 12:19 PM Page: 626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humulin Regular (Insulin Human) C Aleve (Naproxen Sodium) C Rezulin (Troglitazone) C Prilosec (Omeprazole) C Date:04/30/99ISR Number: 3255837-1Report Type:Periodic Company Report #US_981012296 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS UNK Initial or Prolonged Delusion Professional Risperdal Hallucination Company (Risperidone) C Intentional Misuse Representative Lithium C Renal Failure Sertraline C Suicide Attempt Trazodone C Date:04/30/99ISR Number: 3255838-3Report Type:Periodic Company Report #US_981012356 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Study Olanzapine PS 2.5 MG / D Hospitalization - Carcinoma Health DAY Initial or Prolonged Thinking Abnormal Professional Cipro (Ciprofloxacin Hydrochloride) C Sodium Chloride C Albuterol C Novolin N (Insulin Human Injection, Isophane) C Duragesic (Fentanyl) C Date:04/30/99ISR Number: 3255839-5Report Type:Periodic Company Report #US_981012436 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Study Olanzapine PS 15 MG /D DAY Health Placebo SS 1 DSG FORM/ 1 Professional DAY Amaryl (Glimepiride) C Date:04/30/99ISR Number: 3255840-1Report Type:Periodic Company Report #US_990115325 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 7.5 MG/ 1 DAY Initial or Prolonged Hostility Health Prozac (Fluoxetine Professional Hydrochloride) C 24-Jun-2005 12:19 PM Page: 627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255841-3Report Type:Periodic Company Report #US_990115336 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Olanzapine PS 20 MG/QHS AT Initial or Prolonged Health BEDTIME Professional Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Metamucil (Psyllium Hydrophilic Mucilloid) C Multivitamin C Date:04/30/99ISR Number: 3255842-5Report Type:Periodic Company Report #US_990115337 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 20 MG/ 1 AT Initial or Prolonged Pyrexia Professional BEDTIME 6 MON Stupor Depakote (Valproate Semisodium) C Lithium C Date:04/30/99ISR Number: 3255843-7Report Type:Periodic Company Report #US_990115469 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 10 MG/ QHS AT Initial or Prolonged Health BEDTIME Professional Prozac (Fluoxetine Hydrochloride) SS 20 MG/ QAM IN THE MORNING Nitroglycerin (Clyceryl Trinitrate) C Cimetidine C Folic Acid C Lescol (Fluvastatin Sodium) C Atenolol C Aspirin C Nitrostat (Glyceryl Trinitrate) C Levothroid (Levothyroxine Sodium) C Date:04/30/99ISR Number: 3255844-9Report Type:Periodic Company Report #US_990115485 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Study Olanzapine PS 20 MG/1/D AT Initial or Prolonged Hostility Health BEDTIME Paranoia Professional Cogentin (Benzatropine Mesilate) C Prozac (Fluoxetine 24-Jun-2005 12:19 PM Page: 628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:04/30/99ISR Number: 3255845-0Report Type:Periodic Company Report #US_990115549 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 3 MON Professional Company Representative Date:04/30/99ISR Number: 3255846-2Report Type:Periodic Company Report #US_990115552 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanazapine PS 3 MON Professional Company Representative Date:04/30/99ISR Number: 3255847-4Report Type:Periodic Company Report #US_990115555 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 3 MON Professional Company Representative Date:04/30/99ISR Number: 3255848-6Report Type:Periodic Company Report #US_990115558 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hostility Consumer Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Depakote (Valproate Semisodium) C Date:04/30/99ISR Number: 3255849-8Report Type:Periodic Company Report #US_990115568 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Oedema Study Olanzapine PS 10 MG/ AT Health BEDTIME AT Professional BEDTIME Multivitamin C Calcium Carbonate C Lorazepam C Tolnaftate C Date:04/30/99ISR Number: 3255850-4Report Type:Periodic Company Report #US_990115579 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 5 MG/QHS AT Initial or Prolonged Hostility Health BEDTIME Professional Acetaminophen C 24-Jun-2005 12:19 PM Page: 629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ranitidine C Trazodone C Date:04/30/99ISR Number: 3255851-6Report Type:Periodic Company Report #US_990115589 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 5 MG/ 1/ D Initial or Prolonged Health DAY Professional Minocycline C Date:04/30/99ISR Number: 3255852-8Report Type:Periodic Company Report #US_990115610 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Zyprexa (Olanzapine) PS 15 MG/1/D DAY Initial or Prolonged Delusion Health Prozac (Fluoxetine Diarrhoea Professional Hydrochloride) SS 20 MG/ 1/D Hyperglycaemia DAY Psychotic Disorder Adalat (Nifedipine) C Vomiting Lasix (Furosemide) C Lanoxin (Digoxin) C Ativan (Lorazepam) C Cogentin (Benzatropine Mesilate) C Vitamin E C Vitamin C C Date:04/30/99ISR Number: 3255853-XReport Type:Periodic Company Report #US_990115715 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Accident Consumer Zyprexa (Olanzapine) PS 20 MG/ 1 DAY 8 MON Amnesia Chest Pain Drug Ineffective Hypertonia Insomnia Mania Paraesthesia Thinking Abnormal Urinary Incontinence Date:04/30/99ISR Number: 3255854-1Report Type:Periodic Company Report #US_990115741 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Study Olanzapine PS 20 MG Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255855-3Report Type:Periodic Company Report #US_990115763 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Health Zyprexa (Olanzapine) PS 20 MG/ DAY 6 MON Professional Date:04/30/99ISR Number: 3255856-5Report Type:Periodic Company Report #US_990115804 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Literature Zyprexa (Olanzapine) PS 5 MG/ 1 DAY 25 DAY Initial or Prolonged Health L-Dopa C Professional Date:04/30/99ISR Number: 3255857-7Report Type:Periodic Company Report #US_990115861 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Olanzapine PS 2 DSG FORM/ Initial or Prolonged Hyponatraemia Health 1/D DAY Water Intoxication Professional Placebo SS 2 DSG FORM/ 1/D DAY Propranolol C Multivitamin C Vitamin E C Aspirin Enteric Coated K.P. (Acetylsalicylic Acid) C Date:04/30/99ISR Number: 3255858-9Report Type:Periodic Company Report #US_990116197 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Study Olanzapine PS 5 MG/ EVERY Initial or Prolonged Health OTHER DAY Professional Mevacor (Lovastatin) C Aricept (Donepezil Hydrochloride) C Cardizem (Diltiazem Hydrochloride) C Nitroglycerin Transdermal System (Glyceryl Trinitrate) C Aspirin Enteric Coated K.P. (Acetylsalicylic Acid) C Mylanta C Paxil (Paroxetine Hydrochloride) C Gingkomin (Ginko Biloba) C 24-Jun-2005 12:19 PM Page: 631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255859-0Report Type:Periodic Company Report #US_990116207 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 2.5 MG/ 1 DAY Initial or Prolonged Health Professional Date:04/30/99ISR Number: 3255860-7Report Type:Periodic Company Report #US_990217403 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 3 DSG FORM/ 1 Initial or Prolonged Thinking Abnormal Health AT BEDTIME Professional Placebo SS 1 DSG FORM/ 2 DAY Metformin C Insulin Injection, Isophane C Insulin Human Zinc Suspension C Simvastatin C Tretinoin C Date:04/30/99ISR Number: 3255861-9Report Type:Periodic Company Report #US_990217553 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urinary Tract Infection Study Olanzapine PS 1 DSG FORM / Hospitalization - Health 1 IN THE Initial or Prolonged Professional MORNING Placebo SS 2 DSG FORM / 1 AT BEDTIME Naprosyn (Naproxen) C Ultram (Tramadol Hydrochloride) C Multivitamin C Fibercon (Polycarbophil Calcium) C Zoloft (Sertraline Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Risperdal (Risperidone) C Paroxetine C Date:04/30/99ISR Number: 3255862-0Report Type:Periodic Company Report #US_990217585 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 4 DSG FORM/ 1 Initial or Prolonged Euphoric Mood Health DAY Insomnia Professional Naproxen C Mania Ibuprofen C Thinking Abnormal Pepto-Bismol (Bismuth 24-Jun-2005 12:19 PM Page: 632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Subsalicylate) C Alka-Seltzer C Echinacea Extract C Goldenseal C Depakote (Valproate Semisodium) C Date:04/30/99ISR Number: 3255863-2Report Type:Periodic Company Report #US_990217615 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Olanzapine PS 4 DSG FORM/ 1 Initial or Prolonged Insomnia Health AT BEDTIME Psychotic Disorder Professional Placebo SS 1 DSG FORM/ 2 Weight Decreased DAY Lisinopril C Lorazepam C Peri-Colace C Albuterol C Theophylline C Date:04/30/99ISR Number: 3255864-4Report Type:Periodic Company Report #US_990217680 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Haemorrhagic Stroke Professional Glucophage Myasthenic Syndrome Company (Metformin Representative Hydrochloride) C Glucotrol (Glipizide) C Aspirin C Date:04/30/99ISR Number: 3255865-6Report Type:Periodic Company Report #US_990217725 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Movement Disorder Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Sedation Professional Ativan (Lorazepam) C Date:04/30/99ISR Number: 3255866-8Report Type:Periodic Company Report #US_990217731 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS 10 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Pilocarpine C Timoptic (Timolol Maleate) C Multivitamin C Furosemide C Aspirin C Potassium Chloride C Metamucil (Psyllium Hydrophilic Mucilloid) C Colace (Docusate Sodium) C 24-Jun-2005 12:19 PM Page: 633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonidine C Zantac (Ranitidie Hydrochloride) C Miacalcin (Calcitonin, Salmon) C Xalatan (Latanoprost) C Date:04/30/99ISR Number: 3255867-XReport Type:Periodic Company Report #US_990217793 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Zyprexa (Olanzapine) PS 25 MG/ 1 DAY 1 YR Initial or Prolonged Leukopenia Professional Overdose Company Representative Date:04/30/99ISR Number: 3255868-1Report Type:Periodic Company Report #US_990217794 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Olanzapine PS 2.5 MG/ 1 AT Initial or Prolonged Congestive Health BEDTIME Disability Hypokalaemia Professional Date:04/30/99ISR Number: 3255869-3Report Type:Periodic Company Report #US_990217922 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Miosis Health Zyprexa (Olanzapine) PS 20 MG / 1 DAY Initial or Prolonged Pallor Professional Stupor Other Tachycardia Date:04/30/99ISR Number: 3255870-XReport Type:Periodic Company Report #US_990217932 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Syndrome Professional Haldol (Haloperidol) C Other Thrombocytopenia Company Representative Date:04/30/99ISR Number: 3255871-1Report Type:Periodic Company Report #US_990218017 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Zyprexa (Olanzapine) PS 20 MG / 1 AT Initial or Prolonged Hallucination Health BEDTIME Professional 24-Jun-2005 12:19 PM Page: 634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3255872-3Report Type:Periodic Company Report #US_990218051 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10 MG DAY Initial or Prolonged Health Placebo SS 2 MG DAY Professional Date:04/30/99ISR Number: 3255873-5Report Type:Periodic Company Report #US_990218057 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS Initial or Prolonged Health Enalapril Maleate W/ Professional Hydrochlorotiazide C Potassium Chloride C Salicylic Acid C Bupropion C Propoxyphene Napsylate W/ Acetaminophene C Acetaminophen C Covera-Hs (Verapamil Hydrochloride) C Date:04/30/99ISR Number: 3255874-7Report Type:Periodic Company Report #US_990218059 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 2 DSG FORM Initial or Prolonged Health Lansoprazole C Professional Fosinopril C Vanceril (Beclometasone Dipropionate) C Serevent (Salmeterol Xinafoate) C Lithium C Date:04/30/99ISR Number: 3255875-9Report Type:Periodic Company Report #US_990218098 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa (Olanzapine) PS 30 MG/ 1 DAY 3 DAY Dermatitis Health Benadryl Overdose Professional (Diphenhydramine Urinary Incontinence Hydrochloride) C Weight Increased Dilantin (Phenytoin Sodium) C Date:04/30/99ISR Number: 3255876-0Report Type:Periodic Company Report #US_990218159 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Study Olanzapine PS 5 MG / 1 AT Sepsis Health BEDTIME Professional Lotensin (Benazepril Hydrochloride) C 24-Jun-2005 12:19 PM Page: 635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tylenol (Paracetamol) C Date:04/30/99ISR Number: 3255877-2Report Type:Periodic Company Report #US_990218160 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Study Olanzapine PS 5 MG/ 2 DAY Initial or Prolonged Oesophageal Ulcer Health Prozac (Fluoxetine Professional Hydrochloride) C Aspirin C Trazodone C Vitamin B12 C Imdur (Isosorbide Mononitrate) C Ferrous Sulfate C Date:04/30/99ISR Number: 3255878-4Report Type:Periodic Company Report #US_990218304 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10 MG / 1 DAY Initial or Prolonged Health Minocycline C Other Professional Retin A (Tretinoin) C Date:04/30/99ISR Number: 3255879-6Report Type:Periodic Company Report #US_990218318 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 4 DSG FORM / Initial or Prolonged Schizophrenia Health 1 DAY Professional Placebo SS 2 DSG FORM / 1 DAY Lisinopril C Atenolol C Hydrochlorothiazide C Levothyroxine C Date:04/30/99ISR Number: 3255880-2Report Type:Periodic Company Report #US_990318564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Professional (DURATION: A FEW YEARS) Effexor (Venlafaxine Hydrochloride) C Depakote (Valproate Semisodium) C Date:04/30/99ISR Number: 3256081-4Report Type:Periodic Company Report #US_990116212 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Neuroleptic Malignant Health Initial or Prolonged Syndrome Professional 24-Jun-2005 12:19 PM Page: 636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Date:04/30/99ISR Number: 3256084-XReport Type:Periodic Company Report #US_990116216 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Zyprexa (Olanzapine) PS 5MG/1 DAY 5 WK Initial or Prolonged Depression Date:04/30/99ISR Number: 3256088-7Report Type:Periodic Company Report #US_990116219 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS 17.5MG/1 IN Initial or Prolonged Health THE EVENING Professional Prozac C Date:04/30/99ISR Number: 3256093-0Report Type:Periodic Company Report #US_990116227 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS 5MG/1DAY Initial or Prolonged Health Professional Date:04/30/99ISR Number: 3256096-6Report Type:Periodic Company Report #US_990116273 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa (Olanzapine) PS 10MG/1 DAY Initial or Prolonged Blood Alkaline Professional Phosphatase Increased Company Blood Creatine Representative Phosphokinase Increased Csf Test Abnormal Delirium Glucocorticoids Increased Haematuria Hyperbilirubinaemia Hypertonia Hyponatraemia Leukocytosis Mydriasis Personality Disorder Speech Disorder Tremor Urine Abnormality 24-Jun-2005 12:19 PM Page: 637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3256101-7Report Type:Periodic Company Report #US_990116302 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Literature Zyprexa (Olanzapine) PS 100MG/1 DAY 1 DAY Initial or Prolonged Increased Health Acetaminophen C Aspartate Professional Aminotransferase Increased Blood Lactate Dehydrogenase Increased Extrapyramidal Disorder Gastrointestinal Disorder Hostility Hypotension Intentional Misuse Suicide Attempt Tachycardia Thinking Abnormal Thrombocythaemia Date:04/30/99ISR Number: 3256103-0Report Type:Periodic Company Report #US_990116365 Age:88 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Zyprexa (Olanzapine) PS 5MG/1 DAY Initial or Prolonged Apnoea Professional Risperdal C Muscle Spasms Other Demerol C Lanoxin C Toprol Xl C Diovan C Nitroglycerin C Procardia C Date:04/30/99ISR Number: 3256106-6Report Type:Periodic Company Report #US_990116456 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Professional Luvox C Date:04/30/99ISR Number: 3256113-3Report Type:Periodic Company Report #US_990116504 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Study Olanzapine PS 2 DSG FORM/1 Tremor Health IN THE Professional EVENING Depakote C Zocor C Accupril C Atenolol C Ambien C Flonase C 24-Jun-2005 12:19 PM Page: 638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3256118-2Report Type:Periodic Company Report #US_990116553 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 5MG/1 AT Initial or Prolonged Health BEDTIME Professional Sorbitol C Klonopin C Peri-Colace C Aspirin C Depakote C Ativan C Date:04/30/99ISR Number: 3256121-2Report Type:Periodic Company Report #US_990116576 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS Initial or Prolonged Suicide Attempt Professional Depakote C Date:04/30/99ISR Number: 3256125-XReport Type:Periodic Company Report #US_990116663 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Study Olanzapine PS 10MG/1 AT Health BEDTIME Professional Amlodipine C Benztropine C Ibuprofen C Albuterol C Oxazepam C Date:04/30/99ISR Number: 3256130-3Report Type:Periodic Company Report #US_990216907 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10MG/1AT Initial or Prolonged Health BEDTIME Professional Placebo SS 2MG/2 DAY Benztropine Mesylate C Triamcinolone Acetonide C Lidocaine C Aluminum & Magnesium Hydroxide/Dimeticone C Ibuprofen C Multivitamin And Mineral Supplement C Lorazepam C Date:04/30/99ISR Number: 3256133-9Report Type:Periodic Company Report #US_990216995 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 12.5MG/1 DAY Professional Premarin C 24-Jun-2005 12:19 PM Page: 639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3256135-2Report Type:Periodic Company Report #US_990217003 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa (Olanzapine) PS Date:04/30/99ISR Number: 3256138-8Report Type:Periodic Company Report #US_990217140 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Calcium Increased Health Zyprexa (Olanzapine) PS 2.5 MG/3 DAY Blood Potassium Decreased Professional Glipizide C Thrombocythaemia Potassium C Date:04/30/99ISR Number: 3256140-6Report Type:Periodic Company Report #US_990217162 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20MG Initial or Prolonged Health Professional Date:04/30/99ISR Number: 3256142-XReport Type:Periodic Company Report #US_990217169 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20MG Initial or Prolonged Health Professional Date:04/30/99ISR Number: 3256145-5Report Type:Periodic Company Report #US_990217293 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Consumer Zyprexa (Olanzapine) PS 40MG/1 DAY Initial or Prolonged Hostility Health Overdose Professional Date:04/30/99ISR Number: 3256148-0Report Type:Periodic Company Report #US_990217371 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Olanzapine PS 15MG/1 IN THE Initial or Prolonged Dizziness EVENING Injury Fluoxetine Paraesthesia (Fluoxetine Thinking Abnormal Hydrochloride) SS 60MG/1 IN THE MORNING Albuterol C Ativan C 24-Jun-2005 12:19 PM Page: 640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3325961-3Report Type:Periodic Company Report #US_990218046 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sexual Dysfunction Consumer Zyprexa (Olanzapine) PS Date:04/30/99ISR Number: 3325963-7Report Type:Periodic Company Report #US_990217865 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS 20 MG / 1 DAY 3 MON Professional Clonopin C Company Representative Date:04/30/99ISR Number: 3325964-9Report Type:Periodic Company Report #US_990217899 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Zyprexa (Olanzapine) PS 21 MG / 1 DAY 8 MON Seroquel C Date:04/30/99ISR Number: 3325966-2Report Type:Periodic Company Report #US_990217587 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Health Zyprexa (Olanzapine) PS 5 DAY Professional Date:04/30/99ISR Number: 3325968-6Report Type:Periodic Company Report #US_990217453 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS Professional Valproic Acid C Date:04/30/99ISR Number: 3325969-8Report Type:Periodic Company Report #US_990217462 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa (Olanzapine) PS 30 MG / 1 DAY 1 MON Overdose Professional Trilafon C Date:04/30/99ISR Number: 3325971-6Report Type:Periodic Company Report #US_990217344 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 20 MG / 1 DAY 4 MON Professional Tegretol C Artane C 24-Jun-2005 12:19 PM Page: 641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3325972-8Report Type:Periodic Company Report #US_990217235 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urine Abnormality Health Zyprexa (Olanzapine) PS 5 MG / 2 DAY 1 WK Professional Date:04/30/99ISR Number: 3325974-1Report Type:Periodic Company Report #US_990217239 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 30 MG / 1 DAY 5 MON Professional Date:04/30/99ISR Number: 3325975-3Report Type:Periodic Company Report #US_990217148 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Consumer Zyprexa (Olanzapine) PS 2.5 MG / 1 Intestinal Obstruction DAY 4 MON Pain Prozac (Fluoxetine Hydrochloride) SS Synthroid C Prempro C Ativan C Date:04/30/99ISR Number: 3325977-7Report Type:Periodic Company Report #US_990217132 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Zyprexa (Olanzapine) PS 40 MG / 1 DAY Date:04/30/99ISR Number: 3325978-9Report Type:Periodic Company Report #US_990216985 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa (Olanzapine) PS 15 MG / 1 DAY Professional Klonopin C Paxil C Eskalith Cr C Date:04/30/99ISR Number: 3325979-0Report Type:Periodic Company Report #US_990216994 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa (Olanzapine) PS Professional Nortriptyline C Date:04/30/99ISR Number: 3325981-9Report Type:Periodic Company Report #US_990116735 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS 10 MG / 1 DAY Professional Elavil C 24-Jun-2005 12:19 PM Page: 642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3325982-0Report Type:Periodic Company Report #US_990116845 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa (Olanzapine) PS 20 MG / 1 DAY Depakote C Date:04/30/99ISR Number: 3325983-2Report Type:Periodic Company Report #US_990116872 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Literature Zyprexa (Olanzapine) PS 10 MG / 1 AT Health BEDTIME Professional Valproic Acid C Haloperidol C Date:04/30/99ISR Number: 3325984-4Report Type:Periodic Company Report #US_990116585 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Zyprexa (Olanzapine) PS 40 MG / 1 DAY 1 YR Effexor C Lithium C Date:04/30/99ISR Number: 3325986-8Report Type:Periodic Company Report #US_990116601 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Visual Disturbance Consumer Zyprexa (Olanzapine) PS 5 MG / 1 DAY Altace C Paxil C Date:04/30/99ISR Number: 3325987-XReport Type:Periodic Company Report #US_990116640 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 20 MG / 1 DAY Professional Tegretol C Levothroid C Date:04/30/99ISR Number: 3325988-1Report Type:Periodic Company Report #US_990116475 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Strabismus Health Zyprexa (Olanzapine) PS 5 MG / 1 DAY Professional Prozac (Fluoxetine Hydrochloride) SS 40 MG / 1 DAY Date:04/30/99ISR Number: 3327460-1Report Type:Periodic Company Report #US_990319952 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa (Olanzapine) PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3327472-8Report Type:Periodic Company Report #US_990319966 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 50 MG/1 DAY Professional Date:04/30/99ISR Number: 3327473-XReport Type:Periodic Company Report #US_990320029 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Optic Neuritis Zyprexa (Olanzapine) PS 4 WK Red Blood Cell Sedimentation Rate Increased Date:04/30/99ISR Number: 3327475-3Report Type:Periodic Company Report #US_990320075 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Splenomegaly Consumer Zyprexa (Olanzapine) PS 7.5 MG/1 DAY 8 MON Luvox C Date:04/30/99ISR Number: 3327476-5Report Type:Periodic Company Report #US_990319896 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa (Olanzapine) PS Iron Deficiency Anaemia Professional Vivactil C Leukopenia Thrombocytopenia Date:04/30/99ISR Number: 3327477-7Report Type:Periodic Company Report #US_990319909 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa (Olanzapine) PS 20 MG/1 FAY 10 DAY Professional Lithium C Date:04/30/99ISR Number: 3327479-0Report Type:Periodic Company Report #US_990319701 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nephrolithiasis Health Zyprexa (Olanzapine) PS Professional Date:04/30/99ISR Number: 3327480-7Report Type:Periodic Company Report #US_990319569 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 22.5 MG/1 DAY 6 MON Overdose Professional Humalog C Thrombocytopenia Tegretol C 24-Jun-2005 12:19 PM Page: 644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3327482-0Report Type:Periodic Company Report #US_990319408 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 15 MG/1 DAY 3 MON Professional Date:04/30/99ISR Number: 3327484-4Report Type:Periodic Company Report #US_990319032 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Professional Date:04/30/99ISR Number: 3327486-8Report Type:Periodic Company Report #US_990319086 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Consumer Zyprexa (Olanzapine) PS 10 MG/2 DAY Atarax C Date:04/30/99ISR Number: 3327487-XReport Type:Periodic Company Report #US_990318780 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS Professional Dapakote C Date:04/30/99ISR Number: 3327488-1Report Type:Periodic Company Report #US_990318404 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 10 MG/3 DAY Professional Depakote C Klonopin C Risperdal C Date:04/30/99ISR Number: 3327489-3Report Type:Periodic Company Report #US_990318434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Health Zyprexa (Olanzapine) PS Congestive Professional Oedema Company Representative Date:04/30/99ISR Number: 3327491-1Report Type:Periodic Company Report #US_990218258 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menometrorrhagia Consumer Zyprexa (Olanzapine) PS 15 MG/1 DAY Depakote C Zoloft C Lorazepam C 24-Jun-2005 12:19 PM Page: 645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3327492-3Report Type:Periodic Company Report #US_990218279 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Depakote C Date:04/30/99ISR Number: 3327493-5Report Type:Periodic Company Report #US_990218113 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Smear Cervix Abnormal Health Zyprexa (Olanzapine) PS 15 MG/1 DAY 9 MON Professional Date:04/30/99ISR Number: 3327494-7Report Type:Periodic Company Report #US_990218130 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa (Olanzapine) PS Professional Lithium C Company Gabapentin C Representative Date:04/30/99ISR Number: 3327495-9Report Type:Periodic Company Report #US_990218155 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Professional Prilosec C Company Xanax C Representative Prozac C Date:04/30/99ISR Number: 3327496-0Report Type:Periodic Company Report #US_990218055 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 25 MG/1 DAY Professional Trazodone C Zoloft C Date:04/30/99ISR Number: 3327783-6Report Type:Periodic Company Report #US_990116253 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Health Zyprexa Professional (Olanzapine) PS 15 MG/ 1 DAY 3 WK Company Representative Date:04/30/99ISR Number: 3327785-XReport Type:Periodic Company Report #US_990115950 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Prolonged Professional Prozac (Fluoxetine Hydrochloride) SS 40 MG/1 DAY 10 YR 24-Jun-2005 12:19 PM Page: 646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Robitussin-Cf C Klonopin C Date:04/30/99ISR Number: 3327789-7Report Type:Periodic Company Report #US_990116043 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Consumer Zyprexa (Olanzapine) PS Unexpected Date:04/30/99ISR Number: 3327792-7Report Type:Periodic Company Report #US_990116075 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Disorder Health Zyprexa (Olanzapine) PS 10 MG DAY 4 MON Professional Date:04/30/99ISR Number: 3327795-2Report Type:Periodic Company Report #US_990116135 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Inappropriate Health Zyprexa (Olanzapine) PS 5 MG/1 AT Antidiuretic Hormone Professional BEDTIME Secretion Company Zoloft C Representative Date:04/30/99ISR Number: 3327799-XReport Type:Periodic Company Report #US_990116153 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Professional Klonopin C Bactrim C Date:04/30/99ISR Number: 3327801-5Report Type:Periodic Company Report #US_990116156 Age:70 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Professional Company Representative Date:04/30/99ISR Number: 3327804-0Report Type:Periodic Company Report #US_990115355 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blindness Health Zyprexa (Olanzapine) PS 10 MG/1 AT Professional BEDTIME 2 WK Company Representative 24-Jun-2005 12:19 PM Page: 647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/99ISR Number: 3327807-6Report Type:Periodic Company Report #US_990115385 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Professional Prozac (Fluoxetine Hydrochloride) SS 10 MG/DAY Prolixin Decanoate C Date:04/30/99ISR Number: 3327811-8Report Type:Periodic Company Report #US_990115322 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Consumer Zyprexa (Olanzapine) PS Date:04/30/99ISR Number: 3327813-1Report Type:Periodic Company Report #US_981214997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Health Zyprexa (Olanzapine) PS Abnormal Professional Zoloft C Triglycerides C Potassium C Date:04/30/99ISR Number: 3327816-7Report Type:Periodic Company Report #US_981214823 Age:3 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neonatal Disorder Zyprexa (Olanzapine) PS Sedation Tremor Date:04/30/99ISR Number: 3327818-0Report Type:Periodic Company Report #US_981113302 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 5 MG/1 AT Professional BEDTIME Depakote C Zoloft C Clonazepam C Date:04/30/99ISR Number: 3327821-0Report Type:Periodic Company Report #US98010874A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY 2 MON Unexpected Professional Paxil C Date:05/03/99ISR Number: 3252165-5Report Type:Expedited (15-DaCompany Report #EWC990403206 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Mania Foreign Initial or Prolonged Mental Impairment Health Professional 24-Jun-2005 12:19 PM Page: 648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG/DAY Imovane C Lasilix C Cortancyl C Date:05/03/99ISR Number: 3252672-5Report Type:Expedited (15-DaCompany Report #US_990420735 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Darvocet-N Initial or Prolonged Pneumonia Professional (Propoxyphene Suicide Attempt Napsylate) PS Zyprexa (Olanzapine) SS Prozac (Fluoxetine Hydrochloride) SS Anafranil C Depakote C Temazepam C Ultram C Chlordiazepoxide C Date:05/03/99ISR Number: 3252755-XReport Type:Expedited (15-DaCompany Report #US_980807868 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa (Olanzapine) PS 7.5 MG/1 AT Exposure To Therapeutic Professional BEDTIME Drugs Navane C Ectopic Pregnancy Lorazepam C Date:05/03/99ISR Number: 3252756-1Report Type:Expedited (15-DaCompany Report #US_990420092 Age:4 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa (Olanzapine) PS Exposure To Therapeutic Professional Prozac (Fluoxetine Drugs Hydrochloride) SS Convulsion Dyskinesia Date:05/03/99ISR Number: 3252757-3Report Type:Expedited (15-DaCompany Report #GBS99043132 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Atrophy Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Renal Failure Health Amisulpride C Professional Company Representative 24-Jun-2005 12:19 PM Page: 649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/99ISR Number: 3252758-5Report Type:Expedited (15-DaCompany Report #EWC990403218 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Jaundice Health Atenolol C Liver Function Test Professional Parnate C Abnormal Other Date:05/03/99ISR Number: 3252760-3Report Type:Expedited (15-DaCompany Report #EWC990403184 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Agitation Health Leponex C Catatonia Professional Temesta C Cough Company Serlain C Dehydration Representative Dystonia C Dystonia Epilepsy Hypertension Hypotonia Leukocytosis Muscle Contractions Involuntary Poverty Of Speech Pyrexia Sedation Stupor Date:05/03/99ISR Number: 3253409-6Report Type:Expedited (15-DaCompany Report #US_990420630 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 15 MG/1 AT Professional BEDTIME Quetiapine Fumarate C Wellbutrin Sr (Amfebutamone Hydrochloride) C Restoril (Temazepam) C Ibuprofen C Azmacort (Triamcinolone Acetonide) C Prempro C Date:05/03/99ISR Number: 3253412-6Report Type:Expedited (15-DaCompany Report #GBS990403031 Age:63 YR Gender:Male I/FU:F Outcome PT Alanine Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Calcium Decreased Blood Creatinine Increased Blood Glucose Increased 24-Jun-2005 12:19 PM Page: 650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Potassium Increased Blood Urea Increased Circulatory Collapse Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Dry Mouth Health Trifluoperazine C Haemoglobin Decreased Professional Heart Rate Increased Company Malaise Representative Orthostatic Hypotension Pallor Tremor Date:05/03/99ISR Number: 3253414-XReport Type:Expedited (15-DaCompany Report #US_990319098 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Hospitalization - Myocarditis Professional Initial or Prolonged Pleural Effusion Company Pulmonary Congestion Representative Pulmonary Oedema Viral Infection Date:05/04/99ISR Number: 3252142-4Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anhedonia Zyprexa 10mg Hs PS Intervention to Disturbance In Attention Zyrtec SS Prevent Permanent Insomnia Impairment/Damage Medication Error Thinking Abnormal Date:05/06/99ISR Number: 3255056-9Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Zyprexa PS Lilly 10MG HS Muscular Weakness Depakote C Myasthenic Syndrome Synthroid C Ativan C Risperdal C Date:05/10/99ISR Number: 3257917-3Report Type:Expedited (15-DaCompany Report #EWC990403291 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiogenic Shock Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Health Kalium C Initial or Prolonged Professional Digoxin C Company Diaphyllin C Representative 24-Jun-2005 12:19 PM Page: 651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/99ISR Number: 3257919-7Report Type:Expedited (15-DaCompany Report #EWC990403262 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Olanzapine PS 10 MG DAY Health Heroin C Professional Date:05/10/99ISR Number: 3257921-5Report Type:Expedited (15-DaCompany Report #GBS990403177 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Zyprexa (Olanzapine) PS 2.5 MG DAY Initial or Prolonged Health Sulpiride C Professional Other Date:05/10/99ISR Number: 3257923-9Report Type:Expedited (15-DaCompany Report #EWC990403294 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Foreign Zyprexa (Olanzapine) PS 5 MG DAY Health Professional Company Representative Date:05/10/99ISR Number: 3257925-2Report Type:Expedited (15-DaCompany Report #GBS990403152 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Olanzapine PS Therapeutic Health Procyclidine C Intentional Misuse Professional Haloperidol C Diazepam C Propranolol C Date:05/10/99ISR Number: 3257927-6Report Type:Expedited (15-DaCompany Report #GBS990403179 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa (Olanzapine) PS 10 MG DAY Prolonged Health Bendrofluazide C Oedema Peripheral Professional Ibuprofen C Other Date:05/10/99ISR Number: 3257930-6Report Type:Expedited (15-DaCompany Report #GBS99043172 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Disorder Foreign Zyprexa (Olanzapine) PS 15 MG DAY Ulcer Health Valproate Sodium C Professional Amitriptyline C Cloral Betaine C Lorazepam C Co-Praxamol C 24-Jun-2005 12:19 PM Page: 652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/99ISR Number: 3258235-XReport Type:Expedited (15-DaCompany Report #US_980402295 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Zyperxa (Olanzapine) PS 10 MG/1 DAY Drug Toxicity Health Paxil C Ecchymosis Professional Sythroid C Pulmonary Congestion Company Cytomel C Pulmonary Oedema Representative Lorazepam C Date:05/10/99ISR Number: 3258239-7Report Type:Expedited (15-DaCompany Report #US_990319000 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa (Olanzapine) PS 15 MG/1DAY Drug Level Above Professional Trazodone C Therapeutic Date:05/10/99ISR Number: 3258336-6Report Type:Expedited (15-DaCompany Report #GBS990202674 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Foreign Olanzapine PS 10 MG DAY Health Becotide Professional (Beclometasone Other Dipropionate) C Date:05/10/99ISR Number: 3258341-XReport Type:Expedited (15-DaCompany Report #EWC990403151 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Other Professional Other Date:05/10/99ISR Number: 3258344-5Report Type:Expedited (15-DaCompany Report #EWC990202661 Age:60 YR Gender:Male I/FU:F Outcome PT Death Agitation Life-Threatening Aortic Dissection Hospitalization - Blood Pressure Decreased Initial or Prolonged Body Temperature Other Decreased Bradycardia Cardiac Arrest Cardiac Failure Central Venous Pressure Increased Chest Pain Convulsion Electrocardiogram St Segment Elevation Fall Heart Rate Irregular Hyperventilation Myocardial Infarction 24-Jun-2005 12:19 PM Page: 653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Pallor Ventricular Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Artane Professional (Trihexyphenidyl Other Hydrochloride) C Lactulose C Hydrocortisone C Date:05/10/99ISR Number: 3258389-5Report Type:Expedited (15-DaCompany Report #EWC990403087 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Clopixol Professional (Auclopenthixol Company Decanoate) C Representative Parkinane Other (Trihexyphenidyl Hydrochloride) C Rivotril (Clonazepam) C Rohypnol (Flunitrazepam) C Date:05/10/99ISR Number: 3258581-XReport Type:Expedited (15-DaCompany Report #US_990421542 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa (Olanzapine) PS 140 MG /DAY Initial or Prolonged Health Professional Date:05/10/99ISR Number: 3258585-7Report Type:Expedited (15-DaCompany Report #GBS990403180 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa (Olanzapine) PS 10 MG DAY Neutropenia Health Clozapine C Professional Lithium C Other Valproate Sodium C Nefazodone C Clonazepam C Droperidol C Date:05/11/99ISR Number: 3259731-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Olanzapine (Lilly) PS Lilly ORAL 10 MG QD PO Condition Aggravated Zoloft C Extrapyramidal Disorder Tegretol C Joint Stiffness Surtak C Muscle Rigidity Ativan C Oops C 24-Jun-2005 12:19 PM Page: 654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/99ISR Number: 3260836-XReport Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Chest Sound Health Olanzapine 10 Mg Aspiration Professional Tablets (Lilly) PS Lilly ORAL 10 MG PO Q HS 2 DAY Cardiac Arrest Valproic Acid C Lethargy Bupropion C Overdose Trazodone C Oxygen Saturation Decreased Date:05/13/99ISR Number: 3260942-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999000133 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Risperdal (Tablet) Initial or Prolonged Positive Health (Risperidone) PS ORAL MG, DAILY, C-Reactive Protein Professional ORAL Increased Zyprexa (Olanzapine) SS ORAL DAILY, ORAL Creatinine Renal Klorproman Clearance Decreased (Chlorpromazine Drug Ineffective Hydrochloride) SS 50 MG, 3 IN 1 Extrapyramidal Disorder DAY(S) Headache Orsanil Liver Function Test (Thioridazine Abnormal Hydrochloride) SS 50 MG, 3 IN 1 Lupus-Like Syndrome DAY(S) Mental Impairment Cloxan Nail Disorder (Chlorprothixene Pyrexia Hydrochloride) SS 50 MG, 3 IN 1 Vomiting DAY(S) Minulet (Femodene) SS ORAL ORAL Date:05/14/99ISR Number: 3262769-1Report Type:Expedited (15-DaCompany Report #A0086505 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Central Nervous System Health Wellbutrin Initial or Prolonged Stimulation Professional Tablet-Controlled Other Confusional State Company Release PS ORAL 150 MG/THREE Grand Mal Convulsion Representative TIMES PER DA Illusion ORAL Memory Impairment Olanzapine Sedation (Formulation Unnown) SS 10 MG/PER DAY Fluvoxamine Maleate C Lithium Salt C Propranolol Hydrochloride C Lorazepam C Thyroxine Sodium C Date:05/17/99ISR Number: 3262541-2Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Abnormal Zyprexa 10mg PS ORAL 20MG PO QD Hyperphagia Efexor C Weight Increased Date:05/17/99ISR Number: 3263851-5Report Type:Expedited (15-DaCompany Report #US_990521621 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Health Zyprexa (Olanzapine) PS 5 MG/ 1 AT Hospitalization - Barrett'S Oesophagus Professional BEDTIME Initial or Prolonged Dysphonia Other Risperidone C Dyspnoea Haloperidol C Fall Divalproex Sodium C Gastrointestinal Naprosyn (Naproxen) C Haemorrhage Ferrous Sulfate C Gram Stain Positive Methylprednisolone C Haematemesis Chloral Hydrate C Haematochezia Haematocrit Decreased Hearing Impaired Heart Rate Increased Hypoxia Oesophageal Ulcer Oxygen Saturation Decreased Pleural Effusion Pneumonia Pyrexia Respiratory Failure Rib Fracture Vomiting Date:05/17/99ISR Number: 3263855-2Report Type:Expedited (15-DaCompany Report #GBT990500145 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Olanzapine PS 20 MG DAY Initial or Prolonged Dependent Personality Study Fluoxetine C Disorder Health Amisulpride C Drug Effect Decreased Professional Diazepam C Drug Ineffective Other Feeling Abnormal Schizophrenia Stress Date:05/17/99ISR Number: 3263962-4Report Type:Expedited (15-DaCompany Report #GBS990403132 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Dialysis Lower Respiratory Tract Infection Pneumonia 24-Jun-2005 12:19 PM Page: 656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Acute Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Amisulpride C Professional Valproate Sodium C Company Droperidol C Representative Metoclopramide C Lorazepam C Diazepam C Famotidine C Date:05/17/99ISR Number: 3263965-XReport Type:Expedited (15-DaCompany Report #US_990420854 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Prolonged Professional Fluvoxamine C Syncope Company Trazodone C Representative Albuterol C Date:05/17/99ISR Number: 3263968-5Report Type:Expedited (15-DaCompany Report #GBS990302966 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hypothyroidism Health Professional Other Date:05/17/99ISR Number: 3263972-7Report Type:Expedited (15-DaCompany Report #GBS980700986 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Fall Health Procyclidine C Hepatic Rupture Professional Intra-Abdominal Haemorrhage Leg Amputation Polytraumatism Schizophrenia Splenic Rupture Date:05/17/99ISR Number: 3263983-1Report Type:Expedited (15-DaCompany Report #EWC990403153 Age:21 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Bilirubin Increased Initial or Prolonged Blood Creatinine Other Increased C-Reactive Protein Increased Dermatitis Dermatitis Atopic Dizziness Dna Antibody Positive 24-Jun-2005 12:19 PM Page: 657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Ineffective Extrapyramidal Disorder Headache Report Source Product Role Manufacturer Route Dose Duration Hypocalcaemia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Liver Disorder Health Risperdal Lupus-Like Syndrome Professional (Risperidone) C Mental Disorder Other Klorproman Muscle Rigidity (Chlorpromazine Pollakiuria Hydrochloride) C Scleroderma Orsanil Sjogren'S Syndrome (Thioridazine Tracheal Deviation Hydrochloride) C Vomiting Cloxan (Chlorprothixene Hydrochloride) C Minulet C Mercilon C Date:05/17/99ISR Number: 3263985-5Report Type:Expedited (15-DaCompany Report #EWC990202692 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Hospitalization - Pulmonary Oedema Health Valproate Sodium C Initial or Prolonged Renal Failure Professional Respiratory Failure Vomiting Date:05/17/99ISR Number: 3265141-3Report Type:Expedited (15-DaCompany Report #CA_990500494 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Zyprexa (Olanzapine) PS 20 MG/1 DAY Date:05/17/99ISR Number: 3265142-5Report Type:Expedited (15-DaCompany Report #CA_990200373 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Grand Mal Convulsion Health Effexor C Professional Clonazepam C Other Periactin C Imovane C Erythromycin C Ventolin C Date:05/17/99ISR Number: 3265143-7Report Type:Expedited (15-DaCompany Report #CA_990500503 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Blood Creatinine Increased Blood Urea Increased Haematuria Nephritis Interstitial Oliguria 24-Jun-2005 12:19 PM Page: 658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Casts Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 2.5 MG AT Health BEDTIME Professional Risperidone C Other Arotinolol C Hydroxyzine C Domperidone C Thioridazine C Date:05/17/99ISR Number: 3265144-9Report Type:Expedited (15-DaCompany Report #CA_990500506 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Zyprexa (Olanzapine) PS 7.5 MG/1 DAY 8 WK Completed Suicide Health Kemadrin C Coronary Artery Disease Professional Other Date:05/17/99ISR Number: 3265145-0Report Type:Expedited (15-DaCompany Report #CA_990500507 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY 6 MON Injury Health Paxil C Professional Other Date:05/17/99ISR Number: 3265146-2Report Type:Expedited (15-DaCompany Report #GBS990503243 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Increased Health Diazepam C Aspartate Professional Aminotransferase Company Increased Representative Blood Bilirubin Increased Other Jaundice Pruritus Date:05/18/99ISR Number: 3264843-2Report Type:Direct Company Report # Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Olanzepine PS ORAL 10MG PO QHS Hospitalization - Torsade De Pointes ("YEARS" BUT Initial or Prolonged Ventricular Fibrillation NO MED Required 4/26-5/1) Intervention to Propafenone SS 225MG TID Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/99ISR Number: 3265214-5Report Type:Expedited (15-DaCompany Report #S99-AUS-00835-01 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Cipramil PS ORAL 10 MG QD Initial or Prolonged Disorientation Health Cipramil Drug Interaction Professional (Citalopram) SS ORAL 40 MG QD Fatigue Zyprexa SS ORAL 20 MG QD Insomnia Zuclopenthixol Nystagmus Decanoate C Road Traffic Accident Salivary Hypersecretion Date:05/19/99ISR Number: 3267047-2Report Type:Periodic Company Report #8-98316-099A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Effexor Xr Capsules PS ORAL DOSE UNKNOWN Professional ORAL Company Zyprexa (Olanzapine) Representative Tablets SS ORAL ORAL Date:05/21/99ISR Number: 3267696-1Report Type:Expedited (15-DaCompany Report #WAES 99055516 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Os Cosopt PS OPHTHALMIC 3 DROPS OPHT Initial or Prolonged Health Olanzapine SS ORAL 15 MG PO Professional Brimonidine D-Tartrate C Lantanoprost C Therapy Unspecified C Date:05/24/99ISR Number: 3269178-XReport Type:Expedited (15-DaCompany Report #JAOCAN1999000062 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Risperdal Initial or Prolonged Abdominal Pain Health (Unspecified) Required Blood Creatinine Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Intervention to Increased 1 DAY(S) Prevent Permanent Blood Sodium Decreased Olanzapine Impairment/Damage Blood Urea Increased (Olanzapine) SS ORAL 2.5 MG, 1 IN Crystalluria 1 DAY(S) Dermatitis Thioridazine Dialysis (Thioridazine) C Nasopharyngitis Domeperidone Nephritis Interstitial (Domeperidone) C Oliguria Hydroxyzine Urinary Casts (Hydroxyzine) C Vomiting Timolol (Timolol) C Date:05/24/99ISR Number: 3269316-9Report Type:Expedited (15-DaCompany Report #US_990521995 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Duodenal Ulcer Health Initial or Prolonged Haemorrhage Professional 24-Jun-2005 12:19 PM Page: 660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Remeron C Date:05/24/99ISR Number: 3269340-6Report Type:Expedited (15-DaCompany Report #US_990522242 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Prozac(Fluoxetine Medication Error Professional Hydrochloride) PS 80 MG/1 DAY Company Zyprexa(Olanzapine) SS 15 MG/1 DAY Representative Date:05/24/99ISR Number: 3269715-5Report Type:Expedited (15-DaCompany Report #DE_990501171 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 20 MG DAY 17 DAY Initial or Prolonged Idiopathic Literature Thrombocytopenic Purpura Health Thrombocytopenia Professional Date:05/24/99ISR Number: 3269720-9Report Type:Expedited (15-DaCompany Report #DE_981200693 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Blood Creatinine Health Novodigal Increased Professional (Beta-Acetyl Condition Aggravated Digoxin) SS YR Renal Impairment Euthyrox C Schizophrenia Furosemide C Urinary Tract Infection Date:05/24/99ISR Number: 3269725-8Report Type:Expedited (15-DaCompany Report #DE_990501138 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Zyprexa (Olanzapine) PS 17.5 MG DAY 5 MON Initial or Prolonged Colitis Health Pyrexia Professional Date:05/25/99ISR Number: 3269231-0Report Type:Expedited (15-DaCompany Report #EWC990503375 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malignant Melanoma Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Health Dominal Forte C Professional Gewacalm C Company Representative 24-Jun-2005 12:19 PM Page: 661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/99ISR Number: 3269235-8Report Type:Expedited (15-DaCompany Report #GBS990503255 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa (Olanzapine) PS Hospitalization - Difficulty In Walking Health Digoxin C Initial or Prolonged Professional Company Representative Date:05/25/99ISR Number: 3269239-5Report Type:Expedited (15-DaCompany Report #GBS990503260 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Olanzapine PS 15 MG/DAY Myocardial Infarction Health Chlorpromazine C Professional Date:05/25/99ISR Number: 3269448-5Report Type:Expedited (15-DaCompany Report #US_980402295 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Zyprexa (Olanzapine) PS 10 MG 1 DAY Pulmonary Congestion Health Paxil C Pulmonary Oedema Professional Synthroid C Company Cytomel C Representative Cogentin C Other Lorazepam C Effexor C Date:05/25/99ISR Number: 3269472-2Report Type:Expedited (15-DaCompany Report #EWC990403089 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Dyspnoea Health Nozinan C Face Oedema Professional Haldol C Myalgia Company Pruritus Representative Date:05/25/99ISR Number: 3269474-6Report Type:Expedited (15-DaCompany Report #EWC990403291 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Life-Threatening Cardiogenic Shock Health Pneumonia Professional Company Representative Date:05/25/99ISR Number: 3269746-5Report Type:Direct Company Report #52339 Age: Gender: I/FU:I Outcome PT Other Dry Mouth Dysphemia Fatigue 24-Jun-2005 12:19 PM Page: 662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Medication Error Migraine Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Zyrtec (Cetirizine Sedation Hydrochoride) PS Pfizer Syncope Zyprexa (Olanzapine) SS Lilly Date:05/25/99ISR Number: 3269860-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Health Olanzapine PS 10 MG Q AM 20 Intervention to Professional MG QHS Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269862-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Health Olanzapine PS 15 MG BID Intervention to Professional Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269885-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Health Olanzapine PS 15 MG QHS 4 MON Intervention to Increased Professional Prevent Permanent Diabetes Mellitus Impairment/Damage Date:05/25/99ISR Number: 3269890-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Health Olanzapine PS 20 MG QHS Intervention to Professional Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269893-8Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Health Olanzapine PS 5MG BID 2 WK Intervention to Professional Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/99ISR Number: 3269897-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Health Olanzapine PS 12.5MG QHS Intervention to Increased Professional Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269900-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Health Olanzapine PS 10 MG QAM 5MG Intervention to Increased Professional QHS Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269904-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Health Olanzapine PS 10MG QAM 20MG Intervention to Increased Professional QHS Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269905-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Health Olanzapine PS 15 MG QHS 1 MON Intervention to Increased Professional Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269930-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Olanzapine PS 35MG HS >2 YR 2 YR Intervention to Increased Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3269935-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Olanzapine PS 5MG QAM 15MG Intervention to QHS >1YR 1 YR Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/99ISR Number: 3270039-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Olanzapine PS 35MG QD 1 YR Intervention to Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3270041-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Olanzapine PS 15MG QAM 5ML Intervention to Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3270417-XReport Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Zyprexa 2.5 Mg Q Hs Hospitalization - Decreased (Lilly) PS ORAL 2.5 MG PO Q Initial or Prolonged Coma HS Required Miosis Klonopin C Intervention to Overdose Ritalin C Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3270427-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Jaw Disorder Zyprexa 10 Mg 2 Q Hs PS Tardive Dyskinesia Risperidone 3mg 1 Q Trismus Hs SS Paxil C Date:05/27/99ISR Number: 3271254-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Olanzapine By (Eli Intervention to Lilly) PS Eli Lilly ORAL 10MG/DAY PO Prevent Permanent Impairment/Damage Date:06/01/99ISR Number: 3274208-5Report Type:Expedited (15-DaCompany Report #US_990421542 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Alkaline Initial or Prolonged Phosphatase Increased Blood Prolactin Increased Hypertension Intentional Misuse 24-Jun-2005 12:19 PM Page: 665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Laboratory Test Abnormal Sinus Bradycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 140 MG/DAY Health Professional Date:06/01/99ISR Number: 3274279-6Report Type:Expedited (15-DaCompany Report #US_990521995 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Haemorrhage Professional Remeron C Gastrointestinal Other Haemorrhage Weight Increased Date:06/01/99ISR Number: 3274319-4Report Type:Expedited (15-DaCompany Report #GBS990503360 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Zyprexa (Olanzapine) PS 10 MG DAY Health Professional Other Date:06/01/99ISR Number: 3274321-2Report Type:Expedited (15-DaCompany Report #US_990522556 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa ( Initial or Prolonged Diabetes Mellitus Professional Olanzapine) PS 20 MG / 1 DAY Other Inadequate Control Hydrochlorothiazide C Hyperglycaemia Propranolol C Haldol Decanoate (Haloperidol Decanoate) C Cogentin (Benztropine Mesilate) C Tylenol (Paracetamol) C Date:06/01/99ISR Number: 3274324-8Report Type:Expedited (15-DaCompany Report #US_990116735 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Professional Elavil (Amitriptyline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/99ISR Number: 3274358-3Report Type:Expedited (15-DaCompany Report #US_990522714 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Fluoxetine Initial or Prolonged Hostility Health (Fluoxetine Irritability Professional Hydrochloride) PS 60 MG/1 DAY Schizophrenia Zyprexa (Olanzapine) SS 10 MG/1 AT Weight Increased BEDTIME Date:06/01/99ISR Number: 3274371-6Report Type:Expedited (15-DaCompany Report #DE_990301014 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Health Professional Date:06/01/99ISR Number: 3274374-1Report Type:Expedited (15-DaCompany Report #US_990522279 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Blood Sodium Decreased Professional Prozac (Fluoxetine Condition Aggravated Hydrochloride) SS Inappropriate Antidiuretic Hormone Secretion Mental Impairment Polydipsia Date:06/01/99ISR Number: 3274454-0Report Type:Expedited (15-DaCompany Report #EWC990503419 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Favoxil (Fluvoxamine Professional Maleate) C Other Date:06/01/99ISR Number: 3274456-4Report Type:Expedited (15-DaCompany Report #EWC990503449 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Rivotril Professional (Clonazepam) C Company Nitromint (Glyceryl Representative Trinitrate) C Other Date:06/01/99ISR Number: 3274773-8Report Type:Direct Company Report # Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Zyprexa PS ORAL ? PO 24-Jun-2005 12:19 PM Page: 667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3275224-XReport Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypertensive Crisis Haloperidol Hospitalization - Decanoate 200mg Iv PS INTRAMUSCULAR Q MONTH IM Initial or Prolonged Zyprexa 10mg SS ORAL QHS PO Required Intervention to Prevent Permanent Impairment/Damage Date:06/07/99ISR Number: 3277239-4Report Type:Expedited (15-DaCompany Report #EWC990503375 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malignant Melanoma Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Health Dominal Forte C Professional Gewacalm C Company Representative Date:06/07/99ISR Number: 3277241-2Report Type:Expedited (15-DaCompany Report #DE_990200877 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Overdose Health Lorazepam C Pyrexia Professional Other Date:06/07/99ISR Number: 3277242-4Report Type:Expedited (15-DaCompany Report #CA_990500494 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa (Olanzapine) PS 20 MG/1 DAY 1 YR Dizziness Health Malaise Professional Company Representative Date:06/07/99ISR Number: 3277333-8Report Type:Expedited (15-DaCompany Report #US_990522874 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa (Olanzapine) PS Other Cardiac Arrest Professional Valproic Acid C Completed Suicide Bupropion C Intentional Misuse Trazodone C Lethargy Oxygen Saturation Decreased Toxicologic Test Abnormal 24-Jun-2005 12:19 PM Page: 668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/99ISR Number: 3277334-XReport Type:Expedited (15-DaCompany Report #GBS990503395 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ecchymosis Foreign Zyprexa (Olanzapine) PS 10 MG DAY Hospitalization - Gastrointestinal Health Quinine C Initial or Prolonged Haemorrhage Professional Prazosin C Haemoglobin Decreased Other Prostatism C Pancytopenia Senna C Platelet Count Decreased White Blood Cell Count Decreased Date:06/07/99ISR Number: 3277348-XReport Type:Expedited (15-DaCompany Report #US_990522718 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Olanzapine PS 10 MG/1 DAY Health Haloperidol C Professional Lithium C Magnesium Oxide C Chlorpromazine Hydrochloride C Benztropine Mesylate C Lorazepam C Date:06/07/99ISR Number: 3277713-0Report Type:Expedited (15-DaCompany Report #9906597 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zoloft Tablets PS ORAL ORAL Initial or Prolonged Drug Level Above Professional Lithobid SS ORAL 600.00 MG Therapeutic TOTAL:DAILY:O Feeling Drunk RAL Nausea Zyprexa SS ORAL ORAL Tremor Benztropine SS ORAL ORAL Wellbutrin C Neurontin C Klonopin C Ambien C Date:06/07/99ISR Number: 3284524-9Report Type:Periodic Company Report #104936 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Health Accutane Capsules Depression Professional (Isotretinoin) PS ORAL ORAL Drug Interaction Zyprexa (Olanzapine) SS ORAL ORAL Paranoia Minocycline C Date:06/09/99ISR Number: 3278901-XReport Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - Hyperhidrosis Initial or Prolonged Hypotension Nausea Pallor 24-Jun-2005 12:19 PM Page: 669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Zyprexa 2.5mg Qhs PS 2.5MG Q HS Date:06/09/99ISR Number: 3279286-5Report Type:Expedited (15-DaCompany Report #9923064 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Consumer Zoloft Tablets PS ORAL 50.00 MG Initial or Prolonged Hypersomnia TOTAL: DAILY: Sedation ORAL Sleep Disorder Zyprexa SS ORAL 15.00 MG TOTAL:DAILY: ORAL Depakote SS 1000.00 MG TOTAL: DAILY Date:06/14/99ISR Number: 3280911-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Olanzapine 10mg Tab PS 20MG QH Date:06/14/99ISR Number: 3280918-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Olanzepine 10mg Tablets PS ORAL 20MG PO QHS Date:06/14/99ISR Number: 3282171-6Report Type:Expedited (15-DaCompany Report #EWC990503484 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 13 MON Hospitalization - Health Xanax C Initial or Prolonged Professional Digoxin C Company Nitromint C Representative Furosemid C Other Date:06/14/99ISR Number: 3282174-1Report Type:Expedited (15-DaCompany Report #AU_990500615 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Olanzapine PS 17.5 MG/DAY Initial or Prolonged Dyskinesia Health Antihypertensive C Hyperhidrosis Professional Anti-Glaucoma Eye Muscle Spasms Other Drops C Neuroleptic Malignant Syndrome Pyrexia Weight Decreased 24-Jun-2005 12:19 PM Page: 670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/99ISR Number: 3282180-7Report Type:Expedited (15-DaCompany Report #US_990623436 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Zyprexa (Olanzapine) PS 10 MG/1 AT Initial or Prolonged Anger Health BEDTIME Headache Professional Fluoxetine Hypersomnia (Fluoxetine Medication Error Hydrochloride) SS 20 MG/1 DAY Psychiatric Symptom Schizophrenia Vomiting Weight Increased Date:06/14/99ISR Number: 3282184-4Report Type:Expedited (15-DaCompany Report #EWC990603489 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Other Date:06/14/99ISR Number: 3282188-1Report Type:Expedited (15-DaCompany Report #EWC990503488 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Oedema Peripheral Health Professional Other Date:06/14/99ISR Number: 3282320-XReport Type:Expedited (15-DaCompany Report #US_990623118 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS Initial or Prolonged Overdose Professional Excedrin C Respiratory Depression Suicide Attempt Date:06/14/99ISR Number: 3282321-1Report Type:Expedited (15-DaCompany Report #US_990522804 Age:48 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Alkaline Phosphatase Increased Blood Glucose Increased Blood Pressure Systolic Increased Blood Urea Decreased Bronchitis Coma Depressed Level Of Consciousness Dermatitis Dysarthria 24-Jun-2005 12:19 PM Page: 671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Overdose Oxygen Saturation Report Source Product Role Manufacturer Route Dose Duration Decreased Health Zyprexa (Olanzapine) PS 520 MG/DAY Pyrexia Professional Valproic Acid C Respiratory Failure Respiratory Rate Increased Sinus Tachycardia Date:06/14/99ISR Number: 3282322-3Report Type:Expedited (15-DaCompany Report #US_990623293 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa (Olanzapine) PS 300 MG DAY Initial or Prolonged Professional Company Representative Date:06/14/99ISR Number: 3282369-7Report Type:Expedited (15-DaCompany Report #EWC990503485 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG /DAY Drowning Health Seduxen C Professional Company Representative Other Date:06/14/99ISR Number: 3282370-3Report Type:Expedited (15-DaCompany Report #EWC990603506 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Neutropenia Health Professional Other Date:06/14/99ISR Number: 3282371-5Report Type:Expedited (15-DaCompany Report #EWC990603505 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Foreign Zyprexa (Olanzapine) PS 15MG /DAY Initial or Prolonged Blood Bilirubin Increased Health Temesta C Jaundice Professional Dominal C Liver Function Test Other Etumine C Abnormal Date:06/14/99ISR Number: 3282372-7Report Type:Expedited (15-DaCompany Report #EWC990603491 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Other Cardiac Failure Foreign Health Professional 24-Jun-2005 12:19 PM Page: 672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 3 MON Date:06/14/99ISR Number: 3282373-9Report Type:Expedited (15-DaCompany Report #US_990623281 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Cardiac Failure Professional Lasix C Congestive Company Oedema Representative Date:06/14/99ISR Number: 3282627-6Report Type:Expedited (15-DaCompany Report #GBS990503243 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Increased Health Diazepam C Aspartate Professional Clobazam C Aminotransferase Company Alt/Sgpt C Increased Representative Alt/Sgpt C Blood Bilirubin Increased Other Ggt C Jaundice Pruritus Date:06/14/99ISR Number: 3282629-XReport Type:Expedited (15-DaCompany Report #EWC990102587 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa (Olanzapine) PS Life-Threatening Arrhythmia Health Cisordinol-Acutard C Hospitalization - Blood Pressure Professional Duphalac C Initial or Prolonged Fluctuation Other Rivotril C Body Temperature Temazepam "Nm Decreased Pharma" C Brain Oedema Change Of Bowel Habit Colon Cancer Electrolyte Imbalance Faecal Incontinence Gastrointestinal Disorder Ileus Paralytic Intestinal Perforation Malaise Pallor Pulmonary Oedema Vomiting Date:06/21/99ISR Number: 3286421-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Abdominal Pain Upper Olanzapine PS Lilly ORAL 15MG QHS Diabetic Ketoacidosis ORAL Mucosal Dryness Propranolol C Nausea Zoloft C Polydipsia Buspar C Polyuria Tachycardia Vomiting Date:06/21/99ISR Number: 3288034-4Report Type:Expedited (15-DaCompany Report #US_990522714 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Fluoxetine Initial or Prolonged Drug Abuser Health (Fluoxetine Hostility Professional Hydrochloride) PS 60 MG/1 DAY Irritability Zyprexa (Olanzapine) SS 10 MG/1 AT Schizophrenia BEDTIME Toxicologic Test Abnormal Weight Increased Date:06/21/99ISR Number: 3288037-XReport Type:Expedited (15-DaCompany Report #CA_981200273 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Life-Threatening Amnesia Health Prozac (Fluoxetine Hospitalization - Balance Disorder Professional Hydrochloride) C Initial or Prolonged Cardiac Failure Other Allopurinol C Cardio-Respiratory Arrest Benztropine C Confusional State Indomethacin C Convulsion Monopril (Fosinopril Depressed Level Of Sodium) C Consciousness Tylenol W/Codeine Dysarthria No. 3 C Dyskinesia Faecal Incontinence Hallucinations, Mixed Hyperhidrosis Hypertension Myoglobinuria Neuroleptic Malignant Syndrome Pyrexia Respiratory Failure Tachycardia Urinary Incontinence Date:06/21/99ISR Number: 3288117-9Report Type:Expedited (15-DaCompany Report #99CDN10320 Age:51 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Glucose Increased Hospitalization - Blood Pressure Increased Initial or Prolonged Convulsion 24-Jun-2005 12:19 PM Page: 674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Above Therapeutic Extrapyramidal Disorder Report Source Product Role Manufacturer Route Dose Duration Heart Rate Increased Foreign Tegretol Cr Extended Intentional Misuse Health Release Loss Of Consciousness Professional Tablet(Arbamazepine) PS ORAL 2400 MG, ONCE Sedation ORAL Suicide Attempt Olanzapine Capsule (Olanzapine) SS ORAL 600 MG, ONCE, ORAL Date:06/21/99ISR Number: 3288154-4Report Type:Expedited (15-DaCompany Report #EWC990403262 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Olanzapine PS 10 MG/DAY Health Heroin C Professional Other Date:06/21/99ISR Number: 3288160-XReport Type:Expedited (15-DaCompany Report #US_990623118 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 150 MG/DAY Initial or Prolonged Depressed Level Of Professional Excedrin C Consciousness Zoloft C Overdose Respiratory Depression Suicide Attempt Date:06/21/99ISR Number: 3288163-5Report Type:Expedited (15-DaCompany Report #US_990420849 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Health Zyprexa (Olanzapine) PS Hepatic Failure Professional Hypoproteinaemia Liver Function Test Abnormal Overdose Renal Failure Date:06/21/99ISR Number: 3288272-0Report Type:Expedited (15-DaCompany Report #EWC990603589 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Oedema Peripheral Health Tegretol C Other Professional Rivotril C Company Representative Other 24-Jun-2005 12:19 PM Page: 675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/99ISR Number: 3288275-6Report Type:Expedited (15-DaCompany Report #EWC990603586 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Basal Ganglion Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Degeneration Health Seroxat C Blood Creatine Professional Procyclidine C Phosphokinase Increased Other Condition Aggravated Hypertonia Thrombocytopenia Date:06/21/99ISR Number: 3288279-3Report Type:Expedited (15-DaCompany Report #US_990623384 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Hypertension Professional Depakote C Clozaril C Date:06/21/99ISR Number: 3288286-0Report Type:Expedited (15-DaCompany Report #GBS990603479 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Health Initial or Prolonged Professional Date:06/21/99ISR Number: 3288289-6Report Type:Expedited (15-DaCompany Report #US_990623607 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Decreased Professional Cytoxan (Cyclophosphamide) C Effexor C Date:06/21/99ISR Number: 3288291-4Report Type:Expedited (15-DaCompany Report #US_990623411 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Hospitalization - Diabetes Mellitus Professional Synthroid C Initial or Prolonged Diabetic Ketoacidosis Glucophage C Other Embolism Aspirin C Hypothyroidism Mental Impairment Pancreatitis Vomiting Date:06/21/99ISR Number: 3288294-XReport Type:Expedited (15-DaCompany Report #US_990623390 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Intracranial Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Celexa C 24-Jun-2005 12:19 PM Page: 676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/99ISR Number: 3289135-7Report Type:Expedited (15-DaCompany Report #DE_990601233 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Health Professional Other Date:06/21/99ISR Number: 3289138-2Report Type:Expedited (15-DaCompany Report #AU_990600631 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Olanzapine PS 150 MG/DAY Initial or Prolonged Health Diazepam C Professional Other Date:06/21/99ISR Number: 3289139-4Report Type:Expedited (15-DaCompany Report #DE_990601250 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Cardiac Failure Health Cardiomyopathy Professional Myocarditis Other Date:06/21/99ISR Number: 3289142-4Report Type:Expedited (15-DaCompany Report #DE_990601248 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Zyprexa (Olanzapine) PS 25 MG/DAY Hospitalization - Chills Health Tremarit (Metixene Initial or Prolonged Disorientation Professional Hydrochloride) C Neuroleptic Malignant Other Adalat Retard Syndrome (Nifedipine) C Neutropenia Acc(Acetylcysteine) C Parkinson'S Disease Haldol (Haloperidol) C Pneumonia Concor (Bisoprolol Pyrexia Fumarate) C Date:06/21/99ISR Number: 3289144-8Report Type:Expedited (15-DaCompany Report #DE_990601256 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aphasia Foreign Zyprexa (Olanzapine) PS Hospitalization - Cardiac Arrest Health Initial or Prolonged Electrocardiogram Qt Professional Prolonged Other Paralysis Shock 24-Jun-2005 12:19 PM Page: 677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/99ISR Number: 3289153-9Report Type:Expedited (15-DaCompany Report #EWC990603577 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Scan Abnormal Foreign Zyprexa(Olanzapine) PS 15 MG/DAY Drug Level Above Health Seropram(Citolopram Therapeutic Professional Hydrobromide) C Heat Oedema Other Tranxilium(Clorazepa Immobile te Dipotassium) C Myalgia Kemadrin(Procyclidin Oedema Peripheral e Hydrochloride) C Phlebothrombosis Risperdal(Risperidon Stupor e) C Date:06/21/99ISR Number: 3289155-2Report Type:Expedited (15-DaCompany Report #EWC990603526 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Cerebral Infarction Health Paresis Professional Other Date:06/22/99ISR Number: 3288969-2Report Type:Expedited (15-DaCompany Report #1191219A Age:61 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Literature Unknown Therapeutic Health Acetaminophen Intentional Misuse Professional Product PS ORAL UNKNOWN DOSE, PO Olanzapine SS ORAL UNKNOWN DOSE, PO Date:06/22/99ISR Number: 3289370-8Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotitis Zyprexa 15mg PS ORAL 1 PO Q HS Swelling Adalat C Gabapentin C Synthroid C Date:06/22/99ISR Number: 3289393-9Report Type:Direct Company Report # Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Zyprexa PS ORAL ORAL; ONE DOSE Warfarin C Colace C Lactcid C Novadex C Serzone C Trimpox C Kron-Cl C Lanoun C Tums C 24-Jun-2005 12:19 PM Page: 678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prencid C Tylenol C Lasix C Levothroid C Darvoet-N-100 C Ranitidone C Nitro Patch C Haldol C Date:06/23/99ISR Number: 3289460-XReport Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Disorder Zyprexa 5mg PS Eli Lilly INITIAL Erectile Dysfunction -20MG; Eye Disorder MAINTANTE-10M Eye Haemorrhage G Fluid Retention Lung Disorder Nervous System Disorder Renal Disorder Date:06/23/99ISR Number: 3289592-6Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Medication Error Zyprexa 25mg Tablet PS ONE AT Intervention to Priapism BEDTIME Prevent Permanent Impairment/Damage Date:06/25/99ISR Number: 3295545-4Report Type:Periodic Company Report #LBID002980031 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Lithobid Tablets 300 Headache Professional Mg (Lithium Nausea Carbonate) PS ORAL 1200 MG, 2 IN Thinking Abnormal 1 D, PER ORAL Tremor Zyprexa (Olanzapine) SS ORAL 5 MG, PER ORAL Date:06/28/99ISR Number: 3292770-3Report Type:Expedited (15-DaCompany Report #US_990624089 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Phenobarbital Initial or Prolonged Pancreatic Enzymes Professional (Phenobarbital) PS Increased Company Zyprexa (Olanzapine) SS 7.5 MG/ 2 AT Suicidal Ideation Representative BEDTIME Dilantin (Phenytoin Sodium) C Norvasc (Amlodipine Besilate) C 24-Jun-2005 12:19 PM Page: 679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/99ISR Number: 3292771-5Report Type:Expedited (15-DaCompany Report #US_990623607 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Decreased Professional Cytoxan (Cyclophosphamide) C Effexor (Venlafaxine Hydrochloride) C Date:06/28/99ISR Number: 3292772-7Report Type:Expedited (15-DaCompany Report #US_990522718 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Olanzapine PS 10 MG/ 1 DAY Health Haloperidol C Professional Lithium C Other Magnesium Oxide C Chlorpromazine Hydrochloride C Benztropine Mesylate C Lorazepam C Date:06/28/99ISR Number: 3292773-9Report Type:Expedited (15-DaCompany Report #EWC990603489 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Foreign Zyprexa (Olanzapine) PS 10 M/DAY Health Loxen (Nicardipine Professional Hydrochloride) C Other Stilnox (Zolpidem) C Madopar C Risperidone C Moclamine (Moclobemide) C Date:06/28/99ISR Number: 3292774-0Report Type:Expedited (15-DaCompany Report #EWC990503488 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Oedema Peripheral Health Kemadrin Professional (Procyclidine Company Hydrochloride) C Representative Rivotril Other (Clonazepam) C Fluanxol (Flupentixol Dihydrochloride) C Date:06/28/99ISR Number: 3292775-2Report Type:Expedited (15-DaCompany Report #US_990623281 Age:37 YR Gender:Female I/FU:F Outcome PT Death Cardiac Arrest Cardiac Failure Congestive Condition Aggravated 24-Jun-2005 12:19 PM Page: 680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coronary Artery Disease Oedema Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Professional Lasix (Furosemide) C Company Representative Date:06/28/99ISR Number: 3292776-4Report Type:Expedited (15-DaCompany Report #GBS990603479 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Pancreatitis Health Initial or Prolonged Professional Other Date:06/28/99ISR Number: 3292827-7Report Type:Expedited (15-DaCompany Report #US_990623620 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Health Zyprexa (Olanzapine) PS 2.5 MG/ 1 AT Initial or Prolonged Blood Pressure Increased Professional BEDTIME Electrocardiogram St Albuterol C Segment Depression Atrovent Hyperhidrosis (Ipratropium Nausea Bromide) C Pallor Lipitor Supraventricular (Atorvastatin) C Tachycardia Prolixin Decanoate Tachycardia (Fluphenazine Decanoate) C Cogentin (Benzatropine Mesilate) C Trazodone C Tegretol (Carbamazepine) C Multivitamin C Prolixin (Fluphenazine Hydrochloride) C Date:06/28/99ISR Number: 3292829-0Report Type:Expedited (15-DaCompany Report #GBS990603513 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hypotension Health Paroxetine C Professional Other 24-Jun-2005 12:19 PM Page: 681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/99ISR Number: 3292830-7Report Type:Expedited (15-DaCompany Report #EWC990603664 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa (Olanzapine) PS 5 M/DAY Initial or Prolonged Hepatocellular Damage Health Parnate Jaundice Cholestatic Professional (Tranylcypromine Jaundice Hepatocellular Other Sulfate) C Liver Function Test Atenolol C Abnormal Lormetazepam C Date:06/28/99ISR Number: 3292832-0Report Type:Expedited (15-DaCompany Report #EWC990603656 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hepatic Enzyme Increased Health Tegretol Oedema Peripheral Professional (Carbamazepine) C Pancytopenia Other Phenytoin C Date:06/28/99ISR Number: 3292833-2Report Type:Expedited (15-DaCompany Report #EWC990603631 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa (Olanzapine) PS Hospitalization - Shock Health Equanil Initial or Prolonged Suicide Attempt Professional (Meprobamate) C Other Deroxat (Paroxetine Hydrochloride) C Date:06/28/99ISR Number: 3292839-3Report Type:Expedited (15-DaCompany Report #GBS990503260 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Rupture Foreign Olanzapine PS 15 MG DAY Aortic Dissection Health Chlorpromazine C Cardiac Tamponade Professional Circulatory Collapse Delusion Myocardial Infarction Paranoia Pericardial Haemorrhage Date:06/28/99ISR Number: 3293098-8Report Type:Expedited (15-DaCompany Report #US_990623659 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zeprexa (Olanzapine) PS Hospitalization - Professional Depakote C Initial or Prolonged Date:06/28/99ISR Number: 3293337-3Report Type:Expedited (15-DaCompany Report #DE_990601280 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Leukopenia Foreign Initial or Prolonged Neutropenia Health 24-Jun-2005 12:19 PM Page: 682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 30 MG/DAY Tofranil (Imipramine Hydrochloride) C Esiteren C Gastrozepin (Pirenzepine Dihydrochloride) C Metoprolol C Acc (Acetylcysteine) C Date:06/28/99ISR Number: 3293375-0Report Type:Expedited (15-DaCompany Report #CA_990600578 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Zyprexa (Olanzapine) PS 10 MG/AT Initial or Prolonged Pain Health BEDTIME 6 WK Professional Wellbutrin Sr C Somnol C Visken C Prozac C Date:06/28/99ISR Number: 3293376-2Report Type:Expedited (15-DaCompany Report #DE_990501207 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Grand Mal Convulsion Health Saroten C Initial or Prolonged Hypervolaemia Professional Tavor C Hypocalcaemia Other Thyroxin C Hypochloraemia Glianimon C Hyponatraemia Polyuria Date:06/28/99ISR Number: 3293378-6Report Type:Expedited (15-DaCompany Report #DE_990601263 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ventricular Fibrillation Foreign Zyprexa (Olanzapine) PS Hospitalization - Health Initial or Prolonged Professional Other Date:06/28/99ISR Number: 3294417-9Report Type:Expedited (15-DaCompany Report #US_990521825 Age:65 YR Gender:Male I/FU:I Outcome PT Asthenia Confusional State Diabetes Mellitus Non-Insulin-Dependent Fall Glycosylated Haemoglobin Increased Hyperglycaemia 24-Jun-2005 12:19 PM Page: 683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Valproic Acid C Date:06/29/99ISR Number: 3293095-2Report Type:Expedited (15-DaCompany Report #US_990623675 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Atrioventricular Block Professional Asa C Cardiac Disorder Felodipine C Drug Toxicity Iron C Folic Acid C Hydralazine C Isordil C Prevacid C Misoprostol C Multivitamin C Tegretol C Digoxin C Klonopin C Date:07/02/99ISR Number: 3296210-XReport Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Trazodone 50 Mg Hs PS 50 MG HS Initial or Prolonged Syncope Professional Olanzapine 5 Mg Bid SS 5 MG BID Valium C Elavil C Prozac C Metoprolol C Methocarbamol C Tramadol C Date:07/02/99ISR Number: 3298565-9Report Type:Expedited (15-DaCompany Report #2257/9986 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Consumer Deltasone Tablets PS ORAL ORAL Initial or Prolonged Delusion Company Cellcept SS Disability Echopraxia Representative Prograf SS Hallucination, Auditory Zoloft SS Mental Impairment Cyprexia (Zyprexa) SS Psychotic Disorder Date:07/06/99ISR Number: 3297428-2Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Zyprexa PS Zoloft SS 24-Jun-2005 12:19 PM Page: 684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/99ISR Number: 3297644-XReport Type:Expedited (15-DaCompany Report #CA_990600604 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Diabetic Ketoacidosis Health Paxil C Glycosylated Haemoglobin Professional Stelazine C Increased Other Pancreatitis Acute Date:07/06/99ISR Number: 3297645-1Report Type:Expedited (15-DaCompany Report #AU_990600653 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Skin Foreign Olanzapine PS 15 MG/DAY Initial or Prolonged Oedema Health Perindopril C Psoriasis Professional Atenolol C Other Date:07/06/99ISR Number: 3297646-3Report Type:Expedited (15-DaCompany Report #EWC990603712 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Zyprexa (Olanzapine) PS Coordination Abnormal Health Drug Toxicity Professional Lethargy Other Date:07/06/99ISR Number: 3297647-5Report Type:Expedited (15-DaCompany Report #GBS990603565 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa (Olanzapine) PS 5 MG AT Blood Creatine Health BEDTIME Phosphokinase Increased Professional Sinemet C Confusional State Other Entacapone C Hyperhidrosis Sotalol C Medication Error Diazepam C Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Rash Erythematous Urinary Tract Infection Date:07/06/99ISR Number: 3297648-7Report Type:Expedited (15-DaCompany Report #US_990624187 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa (Olanzapine) PS 20 MG/DAY 6 MON Professional Prozac (Fluoxetine Company Hydrochloride) SS 6 MON Representative 24-Jun-2005 12:19 PM Page: 685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/99ISR Number: 3297650-5Report Type:Expedited (15-DaCompany Report #US_990624092 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Zyprexa (Olanzapine) PS Initial or Prolonged Electrocardiogram Professional Cocaine C Abnormal Company Representative Date:07/06/99ISR Number: 3297651-7Report Type:Expedited (15-DaCompany Report #CA_990600621 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Olanzapine PS 5 MG/1 DAY Initial or Prolonged Psychotic Disorder Study Health Professional Other Date:07/06/99ISR Number: 3297652-9Report Type:Expedited (15-DaCompany Report #DE_990601295 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Timonil Professional (Carbamazepine) C Other Date:07/06/99ISR Number: 3297925-XReport Type:Expedited (15-DaCompany Report #EWC990603732 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Exposure To Therapeutic Health Lexomil C Drugs Professional Kidney Malformation Other Date:07/06/99ISR Number: 3298474-5Report Type:Expedited (15-DaCompany Report #EWC990603682 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Foreign Zyprexa (Olanzapine) PS 10 MG / DAY Initial or Prolonged Haematuria Health Valproate Sodium C Haemorrhage Professional Lormetazepam C Idiopathic Thrombocytopenic Purpura Date:07/06/99ISR Number: 3303064-1Report Type:Periodic Company Report #201181 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Klonopin Tablets Initial or Prolonged Feeling Drunk Professional (Clonazepam) PS ORAL ORAL Nausea Other Lithobid (Lithium Tremor Carbonate) 300 Mg SS ORAL 300 MG DAILY ORAL Zyprexa 24-Jun-2005 12:19 PM Page: 686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS ORAL ORAL Benzotropine C Wellbutrin C Neurontin C Ambien C Zoloft C Date:07/07/99ISR Number: 3298118-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Olanzapine 10mg (Lilly) PS Lilly ORAL 20MG PO QD Date:07/07/99ISR Number: 3298119-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Olanzapine 10mg Hospitalization - Depressed Level Of (Zyprexa By Lilly) PS Lilly ORAL 20MG PO QD Initial or Prolonged Consciousness Depakote C Required Drooling Loxitane C Intervention to Lethargy Haldol C Prevent Permanent Urinary Incontinence Ativan C Impairment/Damage Capentin C Date:07/07/99ISR Number: 3298121-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine 10mg (Lilly) PS Lilly 20MG QD Haldol C Cogentan C Depakote C Date:07/07/99ISR Number: 3298135-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Olanzapine 10mg Glycosuria (Zyprexa By Lilly) PS Lilly ORAL 20MG PO QD Hyperglycaemia Depakote C Ketonuria Hydrocortisine Cream C Mesoridazine C Date:07/07/99ISR Number: 3298139-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine (Zyprexa-Lilly) 10mg PS Lilly ORAL 20MG PO QD Inh C Temazepam C Pyndoxine C Haldol C Cogentin C 24-Jun-2005 12:19 PM Page: 687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/99ISR Number: 3299156-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Zyprexa 7.5mg (Lilly) PS Lilly ORAL 15MG PO Q 2000 Depakote C Multi-Vit C Date:07/12/99ISR Number: 3301525-2Report Type:Expedited (15-DaCompany Report #US_990623281 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Hospitalization - Cardiac Arrest Professional Lasix (Furosemide) C Initial or Prolonged Cardiac Failure Company Potassium C Congestive Representative Coronary Artery Disease Dyspnoea Oedema Peripheral Pulse Absent Date:07/12/99ISR Number: 3301529-XReport Type:Expedited (15-DaCompany Report #US_990624089 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Phenobarbital Initial or Prolonged Pancreatic Enzymes Professional (Phenobarbital) PS Increased Company Zyprexa (Olanzapine) SS 7.5 MG/2 AT Suicidal Ideation Representative BEDTIME Dilantin (Phenytoin Sodium) C Norvasc (Amlodipine Besilate) C Date:07/12/99ISR Number: 3301531-8Report Type:Expedited (15-DaCompany Report #US_990623384 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Zyprexa (Olanzapine) PS 20 MG/1DAY Cardiovascular Disorder Professional Depakote (Valproate Cough Semisodium) C Dyspnoea Clozaric (Clozapine) C Pulse Absent Atenolol C Respiratory Disorder Aspirin C Date:07/12/99ISR Number: 3301532-XReport Type:Expedited (15-DaCompany Report #GBT990500145 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Olanzapine PS 20 MG DAY Initial or Prolonged Drug Ineffective Study Fluoxetine C Persecutory Delusion Health Amisulpride C Personality Disorder Professional Diazepam C Psychotic Disorder Other Amitriptyline C Visual Disturbance Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/99ISR Number: 3301633-6Report Type:Expedited (15-DaCompany Report #US_990623390 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Intracranial Health Zyprexa (Olanzapine) PS 10 MG 1 DAY Professional Celexa C Date:07/12/99ISR Number: 3301639-7Report Type:Expedited (15-DaCompany Report #GBS990603513 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa (Olanzapine) PS 10 MG DAY Hypotension Health Paroxetine C Professional Date:07/12/99ISR Number: 3301645-2Report Type:Expedited (15-DaCompany Report #US_990318889 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Study Hept-A-Myl C Health Tercian C Professional Stilnox C Date:07/12/99ISR Number: 3301667-1Report Type:Expedited (15-DaCompany Report #GBS981101935 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Health Thyroxine C Professional Other Date:07/12/99ISR Number: 3301668-3Report Type:Expedited (15-DaCompany Report #EWC990603491 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Company Nozinan C Representative Stilnox C Other Aspegic C Diafusor C Date:07/12/99ISR Number: 3349028-3Report Type:Periodic Company Report #US_990319812 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Evista (Raloxifene Hydrochloride) PS 60 MG/1 DAY 3 MON Zyprexa(Olanzapine) SS 2.5 MG/1 DAY 11 DAY 24-Jun-2005 12:19 PM Page: 689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/99ISR Number: 3301406-4Report Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Olanzapine PS ORAL 10MG, 5MG BID ORAL Date:07/15/99ISR Number: 3304670-0Report Type:Expedited (15-DaCompany Report #9911218 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Agglutinins Positive Foreign Abbott-Depakene PS Abbott ORAL 1.000 GM PO Initial or Prolonged Drug Interaction Health QD Epistaxis Professional Olanzapine SS Haematuria Other Purpura Thrombocytopenia Date:07/15/99ISR Number: 3305187-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Olanzapine 10mg PS ORAL 20MG/DAY PO Fluoxetine C Date:07/16/99ISR Number: 3305353-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Risperidone PS ORAL 6 MG PO QD Neutrophil Count Professional Olanzepine SS ORAL 12.5 MG PO Decreased QHS White Blood Cell Count Decreased Date:07/19/99ISR Number: 3306317-6Report Type:Expedited (15-DaCompany Report #CA_990600611 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Risperdal C Professional Company Representative Other Date:07/19/99ISR Number: 3306328-0Report Type:Expedited (15-DaCompany Report #US_990724635 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Olanzapine PS 12.5 MG/1 DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/99ISR Number: 3306331-0Report Type:Expedited (15-DaCompany Report #EWC990603510 Age:6 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Murmur Foreign Olanzapine PS Initial or Prolonged Complications Of Maternal Health Paroxetine C Exposure To Therapeutic Professional Clonazepam C Drugs Other Eltroxin C Convulsion Neonatal Drug Withdrawal Syndrome Neonatal Muscle Spasms Neonatal Respiratory Distress Syndrome Patent Ductus Arteriosus Date:07/19/99ISR Number: 3306486-8Report Type:Expedited (15-DaCompany Report #US_990319292 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Intracranial Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Hypertension Professional Zetar (Coal Tar) C Deep Vein Thrombosis Hydrocortisone C Lipid Metabolism Disorder Merieux Flu Vaccine C Lupus-Like Syndrome Papilloedema Date:07/19/99ISR Number: 3306586-2Report Type:Expedited (15-DaCompany Report #US_990724635 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Olanzapine PS 10 MG/1 DAY Health Haloperidol C Professional Triazolam C Amobarbital C Brovarin C Date:07/19/99ISR Number: 3306590-4Report Type:Expedited (15-DaCompany Report #US_990623607 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Decreased Professional Cytoxan C Effexor C Date:07/19/99ISR Number: 3306620-XReport Type:Expedited (15-DaCompany Report #EWC990703815 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY White Blood Cell Count Health Leponex C Decreased Professional Other 24-Jun-2005 12:19 PM Page: 691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/99ISR Number: 3306621-1Report Type:Expedited (15-DaCompany Report #EWC990703797 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Dyspnoea Health Floxyfral C Miosis Professional Madopar C Other Tegretol C Requip C Theralene C Equanil C Levodopa C Date:07/19/99ISR Number: 3306654-5Report Type:Expedited (15-DaCompany Report #EWC990703772 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Remeron C Professional Betaserc C Other Lanzo C Risolid C Levolac C Tenox C Date:07/19/99ISR Number: 3306655-7Report Type:Expedited (15-DaCompany Report #DE_990401107 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Pyrexia Health Sedation Professional Ureteric Stenosis Other Date:07/19/99ISR Number: 3306678-8Report Type:Expedited (15-DaCompany Report #US_990624169 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alkalosis Health Zyprexa (Olanzapine) PS 10 MG/1 AT Hospitalization - Depressed Level Of Professional BEDTIME Initial or Prolonged Consciousness Other Rythmol C Other Drug Interaction Cardizem C Drug Level Below Depakote C Therapeutic Lasix C Hyperglycaemia Prevacid C Pco2 Increased Synthroid C Pulmonary Embolism Sepsis Tardive Dyskinesia Torsade De Pointes Ventricular Fibrillation Date:07/19/99ISR Number: 3306679-XReport Type:Expedited (15-DaCompany Report #US_990724650 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Death Cardiac Failure Foreign Electroconvulsive Therapy Health 24-Jun-2005 12:19 PM Page: 692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 20 MG/1 AT BEDTIME Thioridazine C Perphenazine C Carbamazepine C Lorazepam C Benzhexol C Hydrochlorothiazide C Ect C Date:07/19/99ISR Number: 3306681-8Report Type:Expedited (15-DaCompany Report #US_990724645 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nausea Health Zyprexa (Olanzapine) PS Palpitations Professional Serentil C Vertigo Company Tofranil C Representative Benadryl C Date:07/19/99ISR Number: 3306750-2Report Type:Expedited (15-DaCompany Report #EWC990603631 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa (Olanzapine) PS 28 DSG FORM Hospitalization - Intentional Misuse Health Equanil C Initial or Prolonged Shock Professional Deroxat C Suicide Attempt Noctran C Date:07/19/99ISR Number: 3306752-6Report Type:Expedited (15-DaCompany Report #EWC990202785 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acid Base Balance Health Zyprexa (Olanzapine) PS 5 MG/DAY Life-Threatening Abnormal Professional Clomipramine C Hospitalization - Arrhythmia Other Initial or Prolonged Blood Bicarbonate Decreased Blood Creatinine Increased Blood Ph Decreased Cardiac Arrest Hepatosplenomegaly Hyperglycaemia Hyperkalaemia Hypotension Liver Disorder Metabolic Acidosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Oxygen Saturation Decreased Respiratory Failure Sedation 24-Jun-2005 12:19 PM Page: 693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/99ISR Number: 3306754-XReport Type:Expedited (15-DaCompany Report #DE_990601256 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa (Olanzapine) PS 12.5 MG/DAY Hospitalization - Arrhythmia Health Initial or Prolonged Brain Hypoxia Professional Disability Cardiac Arrest Electrocardiogram Qt Prolonged Loss Of Consciousness Muscle Spasms Nausea Neurological Examination Abnormal Ophthalmoplegia Pulse Absent Pupillary Disorder Quadriplegia Shock Sternal Fracture Tracheostomy Ventricular Fibrillation Date:07/19/99ISR Number: 3306819-2Report Type:Expedited (15-DaCompany Report #1191245A Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Analgesic Drug Level Literature Unknown Above Therapeutic Health Acetaminophen Completed Suicide Professional Product PS ORAL UNKNOWN DOSE, Drug Level Above PO 48 HR Therapeutic Aspirin SS ORAL UNKNOWN DOSE, PO 48 HR Verapamil SS Valproic Acid SS Risperidone SS Alprazolam SS Venlafaxine SS Olanzapine SS Ibuprofen SS Date:07/19/99ISR Number: 3306860-XReport Type:Expedited (15-DaCompany Report #8-99193-014A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Effexor PS ORAL 300 MG DAILY Initial or Prolonged Distress Syndrome Professional DISCONTINUED Other Oedema Peripheral IN JAN. 1999; Pulmonary Oedema REINITIATED Sedation (DATE AND Sleep Apnoea Syndrome Lithium SS ORAL ORAL Weight Increased Temazepam SS ORAL 5 TO 7 DOSES DAILY ORAL Zyprexa (Olanzapine) Tablets SS ORAL "AS MUCH AS 25 MG PER DAY" ORAL Temazepam C Zyprexa C 24-Jun-2005 12:19 PM Page: 694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Depakote C Lorazepam C Date:07/19/99ISR Number: 3306932-XReport Type:Expedited (15-DaCompany Report #99F--10628 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Tegretol Lp PS ORAL 300 MG, TID, Initial or Prolonged Drug Interaction Health ORAL Miosis Professional Floxyfral Tablet Respiratory Disorder (Fluvoxamine Maleate) SS ORAL 100 MG, DAILY, ORAL Zyprexa SS ORAL 5 MG, DAILY, ORAL Requip SS ORAL 3 MG DAILY, ORAL Modopar C Modopar Slow Release C Equanil C Date:07/19/99ISR Number: 3307254-3Report Type:Expedited (15-DaCompany Report #AU_990600670 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Olanzapine PS 15 MG/1 IN Initial or Prolonged Medication Error Study THE EVENING Psychotic Disorder Health Brufen C Schizophrenia Professional Diamicron C Sedation Sleep Disorder Social Avoidant Behaviour Date:07/19/99ISR Number: 3307256-7Report Type:Expedited (15-DaCompany Report #EWC990603730 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa (Olanzapine) PS Health Professional Other Date:07/19/99ISR Number: 3307258-0Report Type:Expedited (15-DaCompany Report #EWC990603756 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/99ISR Number: 3307357-3Report Type:Expedited (15-DaCompany Report #1191219A Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Unknown Drug Level Above Health Acetaminophen Therapeutic Professional Product PS ORAL PO Olanzapine SS ORAL PO Date:07/20/99ISR Number: 3306766-6Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Zyprexa 5g Am/10g Qhs PS 5MG/10MG Anafranil 50mg Q Hs SS 50MG Lithuim C Depedrine C Date:07/20/99ISR Number: 3307375-5Report Type:Expedited (15-DaCompany Report #9930344 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Disorder Health Zoloft Tablets PS ORAL 200.00 MG Intervention to Drug Interaction Professional TOTAL DAILY Prevent Permanent Company ORAL Impairment/Damage Representative Zyprexa SS Date:07/20/99ISR Number: 3307488-8Report Type:Expedited (15-DaCompany Report #M0429-99 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Foreign Remeron PS ORAL 15-60 MG/DAY Initial or Prolonged Decreased Health PO Other White Blood Cell Count Professional Zyprexa SS 5-75 MG/DAY Decreased Other Betahistidine Hcl C Chlordiazepoxide C Lactulose C Lansoprazole C Peratsin C Risperdal C Temazepam C Date:07/20/99ISR Number: 3307515-8Report Type:Expedited (15-DaCompany Report #FLUV00399000551 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Floxyfral 100 Mg PS ORAL PO Initial or Prolonged Drug Interaction Other Tegretol SS ORAL 300 MG TID PO Miosis Zyprexa SS ORAL PO Overdose Requip SS ORAL PO Respiratory Disorder Modopar C Theralene C 24-Jun-2005 12:19 PM Page: 696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/99ISR Number: 3308832-8Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Health Zyprexa 10mg (Lilly) PS Lilly ONE TAB QHS 5 MON Intervention to Abnormal Professional Prevent Permanent Impairment/Damage Date:07/21/99ISR Number: 3311169-4Report Type:Expedited (15-DaCompany Report #GBS990703746 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa (Olanzapine) PS 2.5 MG /DAY Initial or Prolonged Gait Disturbance Health Oxybutynin C Neuroleptic Malignant Professional Lansoprazole C Syndrome Other Sertraline C Pyrexia Trimethoprim C Date:07/21/99ISR Number: 3311188-8Report Type:Expedited (15-DaCompany Report #EWC990703810 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholestasis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Chromaturia Health Tercian C Faeces Pale Professional Jaundice Company Pyrexia Representative Other Date:07/22/99ISR Number: 3309951-2Report Type:Direct Company Report # Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Percentage Risperidone PS ORAL 6 MG PO QD Decreased Olanzepine SS 12.5 MG PO Treatment Noncompliance QHS White Blood Cell Count Decreased Date:07/22/99ISR Number: 3310396-XReport Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Haloperidol PS ORAL 10MG BID ORAL Restless Legs Syndrome Olanzapine SS ORAL 30MG QHS ORAL Date:07/26/99ISR Number: 3310548-9Report Type:Expedited (15-DaCompany Report #US_990724980 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Circulatory Collapse Professional Ativan C Drug Interaction Sinequan C Exposure To Extreme Clonidine C Temperature Hypotension 24-Jun-2005 12:19 PM Page: 697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/99ISR Number: 3311007-XReport Type:Expedited (15-DaCompany Report #US_990725007 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amblyopia Literature Zyprexa (Olanzapine) PS 10 MG/DAY Balanitis Candida Health Prozac (Fluoxetine Drug Effect Decreased Professional Hydrochloride) SS 60 MG/DAY Fungal Infection Humulin-Human Nph Hallucination, Auditory Insulin (Rdna) Hypercholesterolaemia (Human Insulin (Rdna Hyperglycaemia Origin) ) SS 45 U/2 DAY Hyperlipidaemia Humulin-Human Oedema Regular Insulin Parkinson'S Disease (Rdna) (Human Polydipsia Insulin (Rdna Polyuria Origin) ) SS Weight Increased Glyburide C Date:07/26/99ISR Number: 3311040-8Report Type:Expedited (15-DaCompany Report #99GB-10458 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Clomipramine Initial or Prolonged Grand Mal Convulsion Health (Clomipramine) PS ORAL 150 MG DAILY, Oedema Peripheral Professional ORAL Other Olanzapine (Olanzapine) SS ORAL 5 MG DAILY, ORAL 1 MON Prempak-C C Hydrocodeine C Date:07/26/99ISR Number: 3311158-XReport Type:Expedited (15-DaCompany Report #CA_990700654 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa (Olanzapine) PS 200 MG Hospitalization - Dystonia Health Initial or Prolonged Influenza Professional Overdose Other Pulmonary Oedema Date:07/26/99ISR Number: 3311160-8Report Type:Expedited (15-DaCompany Report #US_990725015 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS 20 MG Initial or Prolonged Condition Aggravated Study Depression Health Drug Ineffective Professional Paranoia Other Psychotic Disorder Date:07/26/99ISR Number: 3311167-0Report Type:Expedited (15-DaCompany Report #EWC990703809 Age:43 YR Gender:Male I/FU:I Outcome PT Hospitalization - Bradycardia Initial or Prolonged Coma 24-Jun-2005 12:19 PM Page: 698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cyanosis Hypotension Hypothermia Report Source Product Role Manufacturer Route Dose Duration Shock Foreign Zyprexa (Olanzapine) PS 2 DSG FORM Health DAY Professional Xanax C Other Nozinan C Tegretol C Date:07/26/99ISR Number: 3311168-2Report Type:Expedited (15-DaCompany Report #DE_990701351 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Foreign Zyprexa (Olanzapine) PS Pleural Effusion Health Right Ventricular Failure Professional Weight Increased Other Date:07/26/99ISR Number: 3311183-9Report Type:Expedited (15-DaCompany Report #GBS990703747 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Myocardial Ischaemia Health Procyclidine C Professional Temazepam C Other Clomipramine C Sulpiride C Date:07/26/99ISR Number: 3311185-2Report Type:Expedited (15-DaCompany Report #US_990725118 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Condition Aggravated Study Drug Ineffective Health Hallucination Professional Paranoia Other Psychiatric Symptom Schizophrenia Date:07/26/99ISR Number: 3311187-6Report Type:Expedited (15-DaCompany Report #US_990725153 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Zyprexa (Olanzapine) PS 10 MG/ 1 AT Initial or Prolonged Schizophrenia Professional BEDTIME Other Prozac C Date:07/26/99ISR Number: 3311189-XReport Type:Expedited (15-DaCompany Report #US_990725071 Age:41 YR Gender:Male I/FU:I Outcome PT Life-Threatening Ammonia Increased Hospitalization - Blood Culture Positive Initial or Prolonged Blood Triglycerides Increased 24-Jun-2005 12:19 PM Page: 699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Depressed Level Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Diabetic Hyperosmolar Professional Depakote C Coma Loxitane C Drooling Haldol C Glycosuria Ativan C Hyperglycaemia Cogentin C Ketonuria Ferrous Sulfate C Lethargy Folic Acid C Pneumonia Multivitamins Renal Failure Acute W.Minerals C Systemic Candida Urinary Incontinence Date:07/26/99ISR Number: 3311208-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999001432 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Literature Risperdal Hospitalization - Distress Syndrome Health (Unspecified) Initial or Prolonged Blood Ph Increased Professional (Risperidone) PS ORAL ORAL Required Coma Aspirin Intervention to Completed Suicide (Acetylsalicylic Prevent Permanent Intentional Misuse Acid) SS ORAL ORAL Impairment/Damage Loss Of Consciousness Acetaminophen, Multi-Organ Failure (Paracetamol) SS ORAL ORAL Pco2 Decreased Verapamil Po2 Increased (Verapamil) SS ORAL ORAL Valproic Acid (Valproic Acid) SS ORAL ORAL Alprazolam (Alprazolam) SS ORAL ORAL Venlafaxine (Venlafaxine) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Ibuprofen (Ibuprofen) SS ORAL ORAL Date:07/26/99ISR Number: 3311379-6Report Type:Expedited (15-DaCompany Report #US_990623411 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa (Olanzapine) PS 15MG / 1 DAY Hospitalization - Diabetes Mellitus Professional Synthroid C Initial or Prolonged Diabetic Ketoacidosis Hypothyroidism C Other Embolism Hypothyroidism Malaise Mental Disorder Pancreatitis Psychiatric Symptom Superior Vena Caval Occlusion Vomiting 24-Jun-2005 12:19 PM Page: 700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/99ISR Number: 3311389-9Report Type:Expedited (15-DaCompany Report #US_990624089 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Phenobarbital Initial or Prolonged Increased Professional (Phenobarbital) PS 30 MG/1 AT Hallucination Company BEDTIME Pancreatic Enzymes Representative Zyprexa (Olanzapine) SS 7.5 MG/2 AT Increased BEDTIME Suicidal Ideation Dilantin (Phenytoin Sodium) C Norvasc (Amlodipine Besilate) C Date:07/27/99ISR Number: 3311636-3Report Type:Expedited (15-DaCompany Report #8-99196-099A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Efexor Tablets Initial or Prolonged Intentional Misuse Health (Venlafaxine Respiratory Rate Professional Hydrochloride) PS ORAL 1050 MG ONE Increased TIME ORAL Tachycardia Ethanol Solution SS ORAL UNKNOWN AMOUNT OF WINE ORAL Olanzapine SS ORAL ORAL Paracetamol SS ORAL "16" ONE TIME ORAL Paracetamol C Olanzapine C Ethanol C Date:07/28/99ISR Number: 3312811-4Report Type:Expedited (15-DaCompany Report #8-99196-090A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Foreign Efexor Tablets Initial or Prolonged Overdose Health (Venlafaxine Other Tachycardia Professional Hydrochloride) PS ORAL 1800MG Tremor OVERDOSE AMOUNT ORAL Olanzapine Tablets SS ORAL 160MG OVERDOSE AMOUNT ORAL Date:07/30/99ISR Number: 3315547-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Olanzapine PS 10MG ~1YR 1 YR Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3316009-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Olanzapine PS 25MG Intervention to Diabetes Mellitus Prevent Permanent Impairment/Damage Date:07/30/99ISR Number: 3317771-8Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Zyprexa 10 Mg PS ORAL 10MG , QHS PO 3 WK Ecchymosis Klonipin 2 Mg SS ORAL 2MG , TID PO Thrombocytopenia Date:07/30/99ISR Number: 3322955-9Report Type:Periodic Company Report #US_990624088 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 1 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Hydrochlorothiazide C Vitamin E C Ginko Biloba C Centrum Silver C The Brain Iii Energizer C The Brain Iii Am C Lecithin C Date:07/30/99ISR Number: 3322956-0Report Type:Periodic Company Report #US_990624194 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Health Zyprexa (Olanzapine) PS 10 MG DAY 6 WK Professional Mellaril C Company Representative Date:07/30/99ISR Number: 3322957-2Report Type:Periodic Company Report #US_990624286 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 15 MG Initial or Prolonged Health Professional Date:07/30/99ISR Number: 3322959-6Report Type:Periodic Company Report #US_990624338 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa (Olanzapine) PS 15 MG/1 AT Initial or Prolonged Health BEDTIME Professional Depakote C Estrostep C 24-Jun-2005 12:19 PM Page: 702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3322972-9Report Type:Periodic Company Report #US_990624351 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS Initial or Prolonged Health Professional Date:07/30/99ISR Number: 3322986-9Report Type:Periodic Company Report #US_990624398 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Consumer Zyprexa (Olanzapine) PS 10 MG 2 DAY Initial or Prolonged Mania Lithium C Navane C Date:07/30/99ISR Number: 3322989-4Report Type:Periodic Company Report #US_990624421 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Restoril C Nifedipine C Donepezil C Metamucil C Hemorrhadial Ointment C Trazodone C Date:07/30/99ISR Number: 3322991-2Report Type:Periodic Company Report #US_990624429 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Literature Olanzapine PS 10 MG 1/DAY Initial or Prolonged Gamma-Glutamyltransferase Health Ciprofloxacin C Increased Professional Nefazodone C Suicide Attempt Atenolol C Urinary Tract Infection Levothyroxine C Phenytoin C Date:07/30/99ISR Number: 3322994-8Report Type:Periodic Company Report #US_990217680 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Coordination Abnormal Professional Glucophage C Myasthenic Syndrome Company Glucotrol C Representative Aspirin C Date:07/30/99ISR Number: 3322995-XReport Type:Periodic Company Report #US_990217932 Age:48 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Pyrexia 24-Jun-2005 12:19 PM Page: 703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Professional Haldol C Company Depakote C Representative Date:07/30/99ISR Number: 3322997-3Report Type:Periodic Company Report #US_990218051 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Olanzapine PS 10 MG DAY Initial or Prolonged Depression Health Placebo SS 2 MG DAY Professional Vitamin E C Glyburide C Fosinopril C Thiamine C Date:07/30/99ISR Number: 3323000-1Report Type:Periodic Company Report #US_990218098 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa (Olanzapine) PS 30 MG / 1 DAY 3 DAY Dermatitis Health Benadryl C Overdose Professional Dilantin C Urinary Incontinence Seizures C Weight Increased Date:07/30/99ISR Number: 3323003-7Report Type:Periodic Company Report #US_990218304 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10 MG/1 DAY Initial or Prolonged Health Minocycline C Professional Date:07/30/99ISR Number: 3323005-0Report Type:Periodic Company Report #US_990319151 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 20 MG /1 DAY Initial or Prolonged Convulsion Professional Zoloft C Other Hyperglycaemia Hypertension Hypertonia Hyperventilation Leukocytosis Salivary Hypersecretion Tachycardia Urine Abnormality 24-Jun-2005 12:19 PM Page: 704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3323008-6Report Type:Periodic Company Report #US_990319171 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Olanzapine PS 2 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Vasotec C Aspirin C Lanoxin C Imdur C Date:07/30/99ISR Number: 3323012-8Report Type:Periodic Company Report #US_990319225 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypovolaemia Study Zyprexa (Olanzapine) PS 2.5 MG /1 AT Initial or Prolonged Syncope Health BEDTIME Professional Prozac C Furosemide C Lipitor C Ranitidine C Miconazole Nitrate C Insulin Human C Insulin Human C Date:07/30/99ISR Number: 3323015-3Report Type:Periodic Company Report #US_990319249 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 1 DSG FORM/ 1 IN THE MORNING Olanzapine SS 3 DSG FORM/ 1 IN THE EVENING Date:07/30/99ISR Number: 3323016-5Report Type:Periodic Company Report #US_990319808 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 17.5 MG/ 1 AT Initial or Prolonged Schizophreniform Disorder Health BEDTIME Professional Depakote C Benztropine C Sudafed C Inderal C Tylenol C Date:07/30/99ISR Number: 3323020-7Report Type:Periodic Company Report #US_990319877 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS 15 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Clonazepam C Alprazolam C 24-Jun-2005 12:19 PM Page: 705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aluminium & Magnesium Hydroxide/ Dimeticone C Casanthranol W/ Docusate Sodium C Fluoxetine C Ibuprofen C Kaolin/Pectin C Milk Of Magnesia C Nefazodone C Lorazepam C Date:07/30/99ISR Number: 3323025-6Report Type:Periodic Company Report #US_990319943 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 5 MG / 1 AT Initial or Prolonged Professional BEDTIME Company Representative Date:07/30/99ISR Number: 3323029-3Report Type:Periodic Company Report #US_990420085 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Study Olanzapine PS 2 DSG FORM/ 1 Initial or Prolonged Hypertonia Health DAY Schizophreniform Disorder Professional Cogentin C Haldol Decanoate C Psychosis C Date:07/30/99ISR Number: 3323032-3Report Type:Periodic Company Report #US_990420145 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 2 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/ 2 DAY Hydroxyzine C Anxiety C Date:07/30/99ISR Number: 3323037-2Report Type:Periodic Company Report #US_990420229 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pyelonephritis Study Olanzapine PS 2.5 MG/ 2 DAY Hospitalization - Health Cardizem C Initial or Prolonged Professional Oxybutynin C Tylenol C Darvocet-N C Vitamin B12 C Atenolol C 24-Jun-2005 12:19 PM Page: 706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3323042-6Report Type:Periodic Company Report #US_990420302 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Study Olanzapine PS 20 MG Myocardial Infarction Health Vitamin E C Professional Monopril C Asa C Prevacid C Cogentin C Nitroglycerin C Date:07/30/99ISR Number: 3323044-XReport Type:Periodic Company Report #US_990420548 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Olanzapine PS Initial or Prolonged Dysphagia Professional Fluoxetine Other (Fluoxetine Hydrochloride) SS Doxepin C Lisinopril C Hydrochlorothiazide C Simvastatin C Clonazepam C Multivitamin C Date:07/30/99ISR Number: 3323049-9Report Type:Periodic Company Report #US_990420549 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Suicide Attempt Health Lithium C Professional Date:07/30/99ISR Number: 3323054-2Report Type:Periodic Company Report #US_990420579 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Study Olanzapine PS 15 MG/1 AT Initial or Prolonged Pneumonia Health BEDTIME Professional Albuterol C Ibuprofen C Insulin Human C Ipratropium C Multivitamin C Levofloxacin C Date:07/30/99ISR Number: 3323057-8Report Type:Periodic Company Report #US_990420628 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Study Olanzapine PS 5 MG/ 1 DAY Hospitalization - Health Lorazepam C Initial or Prolonged Professional Acetaminophen C Phenytoin Sodium C Furosemide C Ocean Nasal Spray C 24-Jun-2005 12:19 PM Page: 707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Robitussin C Aspirin C Nortriptyline C Date:07/30/99ISR Number: 3323600-9Report Type:Periodic Company Report #US_990623310 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Study Olanzapine PS 2.5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Temazepam C Docusate C Propoxyphene C Date:07/30/99ISR Number: 3323606-XReport Type:Periodic Company Report #US_990623354 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Literature Olanzapine PS 5 MG/2 DAY Hostility Health Haloperidol C Professional Divalproex Sodium C Lithium Carbonate C Benztropine C Bethanechol C Nitrofurantoin C Docusate Sodium C Date:07/30/99ISR Number: 3323616-2Report Type:Periodic Company Report #US_990623404 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Zyprexa (Olanzapine) PS 15 MG / 1 DAY Initial or Prolonged Leukocytosis Professional Depakote C Lisinopril C Lithium C Date:07/30/99ISR Number: 3323622-8Report Type:Periodic Company Report #US_990623422 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa (Olanzapine) PS 7.5 MG / 1 AT Initial or Prolonged Health BEDTIME Professional Ibuprofen C Multivitamin C Premarin C Paxil C Date:07/30/99ISR Number: 3323627-7Report Type:Periodic Company Report #US_990623593 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Study Olanzapine PS 5 MG / 1 DAY Hospitalization - Suicide Attempt Health Fluoxetine Initial or Prolonged Professional (Fluoxetine Hydrochloride) SS 60 MG / 1 DAY 24-Jun-2005 12:19 PM Page: 708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3323634-4Report Type:Periodic Company Report #US_990623619 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 5 MG Initial or Prolonged Psychotic Disorder Health Prozac C Professional Ortho-Novum C Date:07/30/99ISR Number: 3323642-3Report Type:Periodic Company Report #US_990623621 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Literature Olanzapine PS 10 MG / 1 DAY 18 MON Initial or Prolonged Movement Disorder Health Bupropion C Other Neuroleptic Malignant Professional Levothyroxine C Syndrome Docusate Sodium C Weight Decreased Artane (Trihexyphenidyl Hydrochloride) C Date:07/30/99ISR Number: 3323647-2Report Type:Periodic Company Report #US_990623689 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS Initial or Prolonged Convulsion Professional Overdose Date:07/30/99ISR Number: 3323650-2Report Type:Periodic Company Report #US_990623737 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 20 MG / 1 DAY Initial or Prolonged Hostility Health Prolixin C Professional Cogentin C Ativan C Bactrim Ds C Tylenol C Depakote C Date:07/30/99ISR Number: 3323654-XReport Type:Periodic Company Report #US_990623748 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Olanzapine PS 2.5 MG/1 DAY Initial or Prolonged Convulsion Health Aricept C Professional Multivitamin C Date:07/30/99ISR Number: 3323659-9Report Type:Periodic Company Report #US_990623759 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 2.5 MG/1 DAY Initial or Prolonged Health Sinemet C Professional Ativan C Dyazide C Capoten C 24-Jun-2005 12:19 PM Page: 709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Elavil C Ibuprofen C Acetaminophen C Date:07/30/99ISR Number: 3323662-9Report Type:Periodic Company Report #US_990623804 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Study Olanzapine PS 2 DSG FORM / Initial or Prolonged Schizophreniform Disorder Health 1 AT BEDTIME Professional Placebo SS 1 DSG FORM/ 2 DAY Folic Acid C Multivitamins C Thiamine C Chlordiazepoxide C Date:07/30/99ISR Number: 3323667-8Report Type:Periodic Company Report #US_990623833 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Consumer Zyprexa (Olanzapine) PS 10 MG / 3 DAY Initial or Prolonged Overdose Health Prilosec C Weight Increased Professional Lithium C Ativan C Skelaxin C Valium C Acetaminophen W/Oxycodone C Klonopin C Navane C Date:07/30/99ISR Number: 3323671-XReport Type:Periodic Company Report #US_990623868 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 7.5 MG/1 DAY Initial or Prolonged Health Ginkgo Biloba C Professional B Complex C Date:07/30/99ISR Number: 3323673-3Report Type:Periodic Company Report #US_990623896 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 20 MG/DAY Initial or Prolonged Depression Health Tylenol C Emotional Disorder Professional Hallucination Hostility Insomnia 24-Jun-2005 12:19 PM Page: 710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3323676-9Report Type:Periodic Company Report #US_990623915 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 2.5 MG/1 AT Initial or Prolonged Delusion Health BEDTIME Hallucination Professional Potassium Chloride C Paranoia Ibuprofen C Aspirin C Isosorbide Mononitrate C Celexa C Nitroglycerin C Date:07/30/99ISR Number: 3323683-6Report Type:Periodic Company Report #US_990623928 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS Professional Company Representative Date:07/30/99ISR Number: 3323686-1Report Type:Periodic Company Report #US_990623990 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Depakote C Bromocriptine C Date:07/30/99ISR Number: 3323688-5Report Type:Periodic Company Report #US_990623999 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10 MG/1 DAY Initial or Prolonged Health Prozac C Professional Ferrous Sulfate C Date:07/30/99ISR Number: 3323691-5Report Type:Periodic Company Report #US_990624060 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 60 MG/1 DAY Date:07/30/99ISR Number: 3324294-9Report Type:Periodic Company Report #US97033745A Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulse Absent Study Zyprexa (Olanzapine) PS Eli Lilly And Hospitalization - Respiratory Arrest Health Company 10MG/DAY Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324298-6Report Type:Periodic Company Report #US98010496A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Study Zyprexa (Olanzapine) PS 5 MG Hospitalization - Pneumonia Health Nph Iletin (Insulin Initial or Prolonged Professional Injection, Isophane) C Colace (Docusate Sodium) C Iron C Date:07/30/99ISR Number: 3324302-5Report Type:Periodic Company Report #US98015005A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Study Zyprexa (Olanzapine) PS 5 MG / 1 DAY Haemorrhage Health Lithium Carbonate C Melaena Professional Tylenol Cold & Flu (Cotylenol) C Ketoprofen C Tums C Date:07/30/99ISR Number: 3324304-9Report Type:Periodic Company Report #US_980503406 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Study Olanzapine PS Initial or Prolonged Hostility Health Depakote (Valproate Professional Semisodium) C Date:07/30/99ISR Number: 3324306-2Report Type:Periodic Company Report #US_980504206 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accident Study Olanzapine PS 10 MG / 1 AT Hospitalization - Intestinal Obstruction Health BEDTIME Initial or Prolonged Professional Oxycodone C Acetaminophen C Erythromycin C Valaciclovir C Hydrochlorothiazide / Triamterene C Fluoxetine C Lorazepam C Multivitamin C Ascorbic Acid C Lisinopril C Terazosin C Date:07/30/99ISR Number: 3324307-4Report Type:Periodic Company Report #US_980604821 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Study Olanzapine PS 5 MG / D DAY Initial or Prolonged Health Aspirin C Disability Professional Lanoxin (Digoxin) C 24-Jun-2005 12:19 PM Page: 712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324308-6Report Type:Periodic Company Report #US_980606080 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 4 DSG FORM/1 Initial or Prolonged Hallucination Health AT BEDTIME Other Paranoia Professional Placebo SS Lorazepam C Levothyroxine C Carbamazepine C Effexor (Venlafaxine Hydrochloride) C Docusate Sodium C Date:07/30/99ISR Number: 3324310-4Report Type:Periodic Company Report #US_980706868 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS 1 DSG Initial or Prolonged Paranoia Health FORM/DAY Thinking Abnormal Professional Tenormin (Atenolol) C Valproate Sodium C Date:07/30/99ISR Number: 3324315-3Report Type:Periodic Company Report #US_981011786 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Olanzapine PS 10 MG / D DAY Health Lasix (Furosemide) C Professional Zyprexa (Olanzapine) C Aleve (Naproxen Sodium) C Date:07/30/99ISR Number: 3324318-9Report Type:Periodic Company Report #US_981012012 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/QPM IN Initial or Prolonged Diabetes Mellitus Health THE EVENING Lung Disorder Professional Prozac (Fluoxetine Hydrochloride) SS 40 MG/QAM IN THE MORNING Humulin Nph (Insulin Human Injection, Isophane) C Humulin Regular (Insulin Human) C Aleve (Naproxen Sodium) C Rezulin (Troglitazone) C Prilosec (Omeprazole) C 24-Jun-2005 12:19 PM Page: 713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324323-2Report Type:Periodic Company Report #US_981113074 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Insomnia Health Placebo SS Professional Hydroxyzine C Ativan (Lorazepam) C Hydrochlorothiazide C Olanzapine C Divalproex Sodium C Multivitamins C Lorazepam C Verapamil C Vitamin E C Date:07/30/99ISR Number: 3324329-3Report Type:Periodic Company Report #US_981113754 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 15 MG/5 MG Initial or Prolonged Health AM, 10 MG HS Professional DAY Placebo SS Gemfibrozil C Divalproex Sodium C Diazepam C Date:07/30/99ISR Number: 3324332-3Report Type:Periodic Company Report #US_981214423 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 4 DSG FORM/AT Initial or Prolonged Health BEDTIME AT Professional BEDTIME Placebo SS 1 DSG FORM/MORNING AND BEDTIME DAY Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Clozapine C Docusate C Date:07/30/99ISR Number: 3324335-9Report Type:Periodic Company Report #US_981215194 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Alcohol Intolerance Health Placebo SS 2 MG Drug Dependence Professional Atenolol C Hostility Diphenhydramine C Injury Gentamicin C Multivitamin C Timolol Maleate C 24-Jun-2005 12:19 PM Page: 714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324341-4Report Type:Periodic Company Report #US_981215243 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Hallucination Health AT BEDTIME Professional Placebo SS 1 DSG FORM/ 2 DAY Didanosine C Lamivudine C Zidovudine C Trazodone C Combivir C Nelfinavir C Cimetidine C Multivitamin C Zoloft (Sertraline Hydrochloride) C Haldol (Haloperidol) C Vitamin E C Date:07/30/99ISR Number: 3324347-5Report Type:Periodic Company Report #US_990115579 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 5 MG/QHS AT Initial or Prolonged Hostility Health BEDTIME Professional Acetaminophen C Ranitidine C Trazodone C Date:07/30/99ISR Number: 3324354-2Report Type:Periodic Company Report #US_990115589 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 5 MG/1/D DAY Initial or Prolonged Health Minocycline C Professional Date:07/30/99ISR Number: 3324360-8Report Type:Periodic Company Report #US_990217371 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/1 IN Initial or Prolonged Dizziness Health THE EVENING Injury Professional Fluoxetine Paraesthesia (Fluoxetine Thinking Abnormal Hydrochloride) SS 60 MG/1 IN THE MORNING Albuterol C Ativan (Lorazepam) C Date:07/30/99ISR Number: 3324365-7Report Type:Periodic Company Report #US_990217403 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Confusional State Initial or Prolonged Hostility 24-Jun-2005 12:19 PM Page: 715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Study Olanzapine PS 3 DSG FORM/1 Health AT BEDTIME Professional Placebo SS 1 DSG FORM/ 2 DAY Metformin C Insulin Injection, Isophane C Insulin Human Zinc Suspension C Simvastatin C Tretinoin C Ibuprofen C Date:07/30/99ISR Number: 3324369-4Report Type:Periodic Company Report #US_990217553 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 1 DSG FORM/1 Hospitalization - Urinary Tract Infection Health IN THE Initial or Prolonged Professional MORNING Naprosyn (Naproxen) C Ultram (Tramadol Hydrochloride) C Multivitamin C Fibercon (Polycarbophil Calcium) C Zoloft (Sertraline Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Risperdal (Risperidone) C Paroxetine C Date:07/30/99ISR Number: 3324612-1Report Type:Periodic Company Report #US_990522240 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parathyroid Disorder Study Olanzapine PS 2 DSG FORM/ 1 Initial or Prolonged Schizophreniform Disorder Health AT BEDTIME Professional Placebo SS 2 DSG FORM/ 1 IN THE MORNING Ativan C Inderal C Pepcid C Ranitidine C Trazodone C 24-Jun-2005 12:19 PM Page: 716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324615-7Report Type:Periodic Company Report #US_990522399 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 9 WK Initial or Prolonged Health Professional Date:07/30/99ISR Number: 3324618-2Report Type:Periodic Company Report #US_990522518 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 15 MG/DAY Initial or Prolonged Health Nortriptyline C Professional Date:07/30/99ISR Number: 3324619-4Report Type:Periodic Company Report #US_990522519 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Olanzapine PS 15 MG/DAY Hospitalization - Health Initial or Prolonged Professional Date:07/30/99ISR Number: 3324624-8Report Type:Periodic Company Report #US_990522540 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Prozac (Fluoxetine Initial or Prolonged Diabetes Mellitus Professional Hydrochloride) PS 20 MG/ 1 DAY Dyspnoea Zyprexa (Olanzapine) SS 7.5 MG/1 DAY Hyperglycaemia Depakote C Hypotension Stomatitis Weight Decreased Date:07/30/99ISR Number: 3324626-1Report Type:Periodic Company Report #US_990522586 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Study Olanzapine PS 1 DSG FORM/ 1 Initial or Prolonged Schizophreniform Disorder Health AT BEDTIME Professional Effexor C Trazodone C Vicodin C Multivitamin C Estratest C Prilosec C Betamethasone C Cipro C Rocephin C 24-Jun-2005 12:19 PM Page: 717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324628-5Report Type:Periodic Company Report #US_990522662 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG/ 1 DAY Initial or Prolonged Health Ativan C Professional Date:07/30/99ISR Number: 3324631-5Report Type:Periodic Company Report #US_990522667 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 5 MG/ 1 AT Initial or Prolonged Confusional State Health BEDTIME Insomnia Professional Hyzaar C Aspirin C Date:07/30/99ISR Number: 3324634-0Report Type:Periodic Company Report #US_990522678 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS Initial or Prolonged Hostility Health Placebo SS Personality Disorder Professional Valproic Acid C Fluphenazine C Lorazepam C Docusate Sodium C Lansoprazole C Lorazepam C Date:07/30/99ISR Number: 3324635-2Report Type:Periodic Company Report #US_990522742 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Study Olanzapine PS 10 MG Life-Threatening Health Hospitalization - Professional Initial or Prolonged Date:07/30/99ISR Number: 3324637-6Report Type:Periodic Company Report #US_990522776 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 15 MG/DAY Initial or Prolonged Health Zantac C Disability Professional Cardizem C Synthroid C Aspirin C Diclofenac Sodium C Tiimolol Maleate C Ibuprofen C Xalatan C 24-Jun-2005 12:19 PM Page: 718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324639-XReport Type:Periodic Company Report #US_990522926 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Neuroleptic Malignant Professional Clozaril C Syndrome Company Pyrexia Representative Date:07/30/99ISR Number: 3324641-8Report Type:Periodic Company Report #US_990522930 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Zyprexa (Olanzapine) PS 10 MG /1 DAY Initial or Prolonged Leukocytosis Professional Other Neuroleptic Malignant Company Syndrome Representative Pyrexia Date:07/30/99ISR Number: 3324642-XReport Type:Periodic Company Report #US_990522937 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 3 DSG FORM/ 1 Initial or Prolonged Hostility Health AT BEDTIME Schizophreniform Disorder Professional Placebo SS 1 DSG FORM/ 2 DAY Benadryl C Multiple Vitamins C Folic Acid C Thiamine C Date:07/30/99ISR Number: 3324643-1Report Type:Periodic Company Report #US_990623057 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Professional Haldol C Company Representative Date:07/30/99ISR Number: 3324658-3Report Type:Periodic Company Report #US_990623153 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 2 DSG FORM Initial or Prolonged Health Placebo SS 1 DSG FORM/ 2 Professional DAY Date:07/30/99ISR Number: 3324661-3Report Type:Periodic Company Report #US_990623190 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Zyprexa (Olanzapine) PS 20 MG/ AT Professional BEDTIME Other Risperidone C Paxil C 24-Jun-2005 12:19 PM Page: 719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324664-9Report Type:Periodic Company Report #US_990623204 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Literature Olanzapine PS 15 MG/ 1 AT Initial or Prolonged Health BEDTIME 12 DAY Disability Professional Date:07/30/99ISR Number: 3324666-2Report Type:Periodic Company Report #US_990623289 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Pyrexia Professional Anafranil C Rhabdomyolysis Neurotin C Klonopin C Cogentin C Date:07/30/99ISR Number: 3324669-8Report Type:Periodic Company Report #US_990623298 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Blood Creatine Professional Lithium C Phosphokinase Increased Company Depakote C Confusional State Representative Hypertonia Salivary Hypersecretion Date:07/30/99ISR Number: 3324674-1Report Type:Periodic Company Report #US_990420644 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Study Olanzapine PS 25 MG/1 AT Hospitalization - Syndrome Health BEDTIME Initial or Prolonged Professional Ativan C Date:07/30/99ISR Number: 3324676-5Report Type:Periodic Company Report #US_990420719 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Study Olanzapine PS 5 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Tylenol C Xalatan C Artificial Tears C Multivitamin C Date:07/30/99ISR Number: 3324692-3Report Type:Periodic Company Report #US_990420770 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Study Olanzapine PS 2.5 MG/1 DAY Initial or Prolonged Health Multivitamin C Professional Seborrhea Ointment C Bacitracin C Acetaminophen C 24-Jun-2005 12:19 PM Page: 720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Terazosin C Hydrochlorothiazide/ Triamterene C Docusate C Aloes C Date:07/30/99ISR Number: 3324693-5Report Type:Periodic Company Report #US_990420857 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Date:07/30/99ISR Number: 3324696-0Report Type:Periodic Company Report #US_990421104 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Increased Professional Aspartate Aminotransferase Increased Convulsion Hyponatraemia Muscle Twitching Neuroleptic Malignant Syndrome Date:07/30/99ISR Number: 3324698-4Report Type:Periodic Company Report #US_990421149 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa (Olanzapine) PS 25 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 40 MG/ 1 DAY Date:07/30/99ISR Number: 3324701-1Report Type:Periodic Company Report #US_990421258 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Cancer Study Olanzapine PS 5 MG/1 AT Health BEDTIME Professional Multivitamis W/ Minerals C Aspirin C Zoloft C Date:07/30/99ISR Number: 3324703-5Report Type:Periodic Company Report #US_990421267 Age:34 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Intentional Misuse 24-Jun-2005 12:19 PM Page: 721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 500 MG DAY Professional Alprazolam C Company Klonopin C Representative Date:07/30/99ISR Number: 3324704-7Report Type:Periodic Company Report #US_990421327 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 10 MG/1 IN Initial or Prolonged Health THE EVENING Professional Prozac (Fluoxetine Hydrochloride) SS 60 MG/1 IN THE MORNING Plaquenil C Naprosyn C Plendil C Tagamet C Tylenol C Vitamins C Date:07/30/99ISR Number: 3324705-9Report Type:Periodic Company Report #US_990421336 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Health DAY Professional Tenormin C Depakote C Date:07/30/99ISR Number: 3324708-4Report Type:Periodic Company Report #US_990421366 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 4 DSG FORM/1 Initial or Prolonged Hostility Health AT BEDTIME Personality Disorder Professional Placebo SS 1 DSG FORM/2 Schizophreniform Disorder DAY Valproic Acid C Docusate Sodium C Lansoprazole C Lorazepam C Date:07/30/99ISR Number: 3324711-4Report Type:Periodic Company Report #US_990421484 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Health Valproic Acid SS 1000 MG/2 DAY Professional Fluoxetine C Synthroid C Prempro C 24-Jun-2005 12:19 PM Page: 722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3324713-8Report Type:Periodic Company Report #US_990421499 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Study Olanzapine PS 5 MG Health Zantac C Professional Synthroid C Zocor C Sorbitol C Miacalcin C Monopril C Paxil C Buspar C Colace C Lithium C Trental C Date:07/30/99ISR Number: 3324715-1Report Type:Periodic Company Report #US_990421564 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 10 MG/ 1 IN Initial or Prolonged Paranoia Health THE MORNING Professional Tylenol C Date:07/30/99ISR Number: 3324717-5Report Type:Periodic Company Report #US_990521654 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Study Olanzapine PS 5 MG/1 AT Hospitalization - Cardiac Failure Health BEDTIME Initial or Prolonged Congestive Professional Oxazepam C Hostility Lorazepam C Injury Atenolol C Donepezil C Sertraline C Digoxin C Gabapentin C Dulcolax C Date:07/30/99ISR Number: 3324734-5Report Type:Periodic Company Report #US_990521897 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Health DAY Professional Placebp SS 2 DSG FORM/1 DAY Nicotine Dermal Patch C Chloral Hydrate C Date:07/30/99ISR Number: 3324735-7Report Type:Periodic Company Report #US_990521987 Age:42 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased 24-Jun-2005 12:19 PM Page: 723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 20 MG/1 AT Professional BEDTIME Lorazepam C Lansoprazole C Lithium C Haloperidol C Diphenhydramine C Sertraline C Date:07/30/99ISR Number: 3324737-0Report Type:Periodic Company Report #US_990522020 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5 MG/1 DAY Initial or Prolonged Injury Health Professional Date:07/30/99ISR Number: 3324739-4Report Type:Periodic Company Report #US_990522101 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 15 MG/DAY Initial or Prolonged Health Depakote C Professional Date:07/30/99ISR Number: 3324740-0Report Type:Periodic Company Report #US_990522167 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Study Olanzapine PS 5 MG/1 AT Dysarthria Health BEDTIME Fall Professional Coumadin C Movement Disorder Digoxin C Vision Blurred Relafen C Vomiting Multivitamin C Date:07/30/99ISR Number: 3358474-3Report Type:Periodic Company Report #US-990420721 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Consumer Zyprexa (Olanzapine) PS 20 MG/1 DAY 1 YR Date:07/30/99ISR Number: 3358476-7Report Type:Periodic Company Report #US_990420655 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatosplenomegaly Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Professional Klonopin (Clonazepam) C Benadryl (Diphenhydramine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3358478-0Report Type:Periodic Company Report #US_990420672 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa (Olanzapine) PS Professional Ambien (Zolpidem Tartrate) C Date:07/30/99ISR Number: 3358479-2Report Type:Periodic Company Report #US_990420260 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Date:07/30/99ISR Number: 3358481-0Report Type:Periodic Company Report #US_990420267 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Purpura Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Colace (Docusate Sodium) C Beconase (Beclometasone Dipropionate) C Date:07/30/99ISR Number: 3358483-4Report Type:Periodic Company Report #US_990319569 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 22.5 MG/1 DAY 6 MON Overdose Professional Humalog (Insulin Thrombocytopenia Lispro) C Tegretol (Carbamazepine) C Date:07/30/99ISR Number: 3358491-3Report Type:Periodic Company Report #US_990319468 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa (Olanzapine) PS 25 MG/1 DAY Overdose Professional Company Representative Date:07/30/99ISR Number: 3358494-9Report Type:Periodic Company Report #US_990318780 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS Professional Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3358498-6Report Type:Periodic Company Report #US_990319032 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Professional Date:07/30/99ISR Number: 3358501-3Report Type:Periodic Company Report #US97063280A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Therapeutic Professional Lithium C Hormone Level Abnormal Depakote (Valproate Hypercalcaemia Semisodium) C Mellaril (Thioridazine Hydrochloride) C Date:07/30/99ISR Number: 3358504-9Report Type:Periodic Company Report #US_990420928 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Electrocardiogram Qt Professional Depakote (Valproate Prolonged Semisodium) C Klonopin (Clonazepam) C Prolixin (Fluphenazine Hydrochloride) C Synthroid (Levothyroxine Sodium) C Date:07/30/99ISR Number: 3358506-2Report Type:Periodic Company Report #US_990421037 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperthyroidism Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Company Representative Date:07/30/99ISR Number: 3358510-4Report Type:Periodic Company Report #US_990421042 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperthyroidism Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Professional Company Representative 24-Jun-2005 12:19 PM Page: 726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3358513-XReport Type:Periodic Company Report #US_990421044 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Penis Disorder Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Professional Depakote (Valproate Semisodium) C Date:07/30/99ISR Number: 3358518-9Report Type:Periodic Company Report #US_990421049 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anticholinergic Syndrome Health Zyprexa (Olanzapine) PS Professional Company Representative Date:07/30/99ISR Number: 3358521-9Report Type:Periodic Company Report #US_990421072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Testicular Failure Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Professional Date:07/30/99ISR Number: 3358525-6Report Type:Periodic Company Report #US_990421087 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS Professional Prilosec (Omeprazole) C Date:07/30/99ISR Number: 3358529-3Report Type:Periodic Company Report #US_990421272 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa (Olanzapine) PS Abnormal Professional Company Representative Date:07/30/99ISR Number: 3358533-5Report Type:Periodic Company Report #US_990421173 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Professional Darvocet-N 100 C Company Flexeril Representative (Cyclobenzaprine Hydrochloride) C Glucophage (Metformin Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Premarin (Estrogens Conjugated) C 24-Jun-2005 12:19 PM Page: 727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medroxyprogesterone C Levothyroxine C Celebrex C Effexor (Venlafaxine Hydrochloride) C Date:07/30/99ISR Number: 3358536-0Report Type:Periodic Company Report #US_990421255 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cutaneous Lupus Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY 2 WK Erythematosus Professional Depakote (Valproate Semisodium) C Benzodiazepine C Date:07/30/99ISR Number: 3358544-XReport Type:Periodic Company Report #US_990624475 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 60 MG/DAY 1 MON Professional Xanax C Date:07/30/99ISR Number: 3358547-5Report Type:Periodic Company Report #US_990624491 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Odour Abnormal Health Zyprexa (Olanzapine) PS Professional Lithobid C Date:07/30/99ISR Number: 3358553-0Report Type:Periodic Company Report #US_990624305 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa (Olanzapine) PS 20 MG/1 DAY 4 MON Intentional Misuse Professional Artane C Buspar C Paxil C Zantac C Date:07/30/99ISR Number: 3358556-6Report Type:Periodic Company Report #US_990624151 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Consumer Zyprexa (Olanzapine) PS 20 MG DAY Overdose Date:07/30/99ISR Number: 3358560-8Report Type:Periodic Company Report #US_990624012 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Zyprexa (Olanzapine) PS 10 MG DAY 1 YR Increased Professional Wellbutrin C Klonopin C Neurontin C Lipitor C 24-Jun-2005 12:19 PM Page: 728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3358563-3Report Type:Periodic Company Report #US_990623992 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 4 DAY Professional Company Representative Date:07/30/99ISR Number: 3358566-9Report Type:Periodic Company Report #US_990623984 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Adrenal Insufficiency Health Zyprexa (Olanzapine) PS 5 MG/1 DAY 5 MON Professional Date:07/30/99ISR Number: 3358568-2Report Type:Periodic Company Report #US_990623664 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 30 MG/DAY Psychotic Disorder Professional Company Representative Date:07/30/99ISR Number: 3358572-4Report Type:Periodic Company Report #US_990623685 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glycosuria Consumer Zyprexa (Olanzapine) PS Company Representative Date:07/30/99ISR Number: 3358576-1Report Type:Periodic Company Report #US_990623445 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Consumer Zyprexa (Olanzapine) PS 15 MG/1 DAY Unexpected Neurontin C Celexa C Glucophage C Tetrabenazine C Navane C Glucotrol C Date:07/30/99ISR Number: 3358579-7Report Type:Periodic Company Report #US_990623418 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 25 MG/DAY Professional Company Representative 24-Jun-2005 12:19 PM Page: 729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3358584-0Report Type:Periodic Company Report #US_990623187 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Prozac (Fluoxetine Leukopenia Professional Hydrochloride) PS 60 MG DAY 6 WK Zyprexa (Olanzapine) SS 5 MG DAY 36 DAY Date:07/30/99ISR Number: 3358586-4Report Type:Periodic Company Report #US_990623108 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa (Olanzapine) PS Professional Acetaminophen C Xanax C Remeron C Ritalin C Date:07/30/99ISR Number: 3358591-8Report Type:Periodic Company Report #US_990623122 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urine Abnormality Consumer Zyprexa (Olanzapine) PS 2.5 MG/1 DAY 6 MON Eskalith C Date:07/30/99ISR Number: 3358596-7Report Type:Periodic Company Report #US_990522743 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cyst Health Zyprexa (Olanzapine) PS 15 MG/1 AT Professional BEDTIME Company Zoloft C Representative Trazodone C Date:07/30/99ISR Number: 3358601-8Report Type:Periodic Company Report #US_990522735 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 5 MG/1 DAY 3 DAY Professional Date:07/30/99ISR Number: 3358606-7Report Type:Periodic Company Report #US_990522026 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Visual Disturbance Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY 10 DAY Professional Date:07/30/99ISR Number: 3358611-0Report Type:Periodic Company Report #US_990522064 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS Professional Neurontin C 24-Jun-2005 12:19 PM Page: 730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3358615-8Report Type:Periodic Company Report #US_990522067 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS Professional Neurontin C Date:07/30/99ISR Number: 3358619-5Report Type:Periodic Company Report #US_990521946 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Splenomegaly Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Prozac (Fluoxetine Hydrochloride) SS 20 MG/IN THE MORNING Date:07/30/99ISR Number: 3358621-3Report Type:Periodic Company Report #US_990521805 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa (Olanzapine) PS 22.5 MG/1 DAY Overdose Professional Depakote C Neurontin C Dexedrine C Date:07/30/99ISR Number: 3358625-0Report Type:Periodic Company Report #US_990521618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photophobia Health Zyprexa (Olanzapine) PS Professional Date:08/02/99ISR Number: 3316114-3Report Type:Expedited (15-DaCompany Report #US_990724980 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa (Olanzapine) PS 10 MG / 1 DAY Circulatory Collapse Professional Ativan C Sinequan C Clonidine C Date:08/02/99ISR Number: 3316115-5Report Type:Expedited (15-DaCompany Report #US_980300560 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Excessive Masturbation Literature Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Inappropriate Affect Health Prolixin C Insomnia Professional Depakote C Mania Clonazepam C Fluphenazine Hydrochloride C Paranoid Schizophrenia C Diphenhydramine C 24-Jun-2005 12:19 PM Page: 731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/99ISR Number: 3316116-7Report Type:Expedited (15-DaCompany Report #GBS990302966 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hypothyroidism Health Professional Other Date:08/02/99ISR Number: 3316656-0Report Type:Expedited (15-DaCompany Report #US-990725336 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 20MG 1 DAY 3 MON Initial or Prolonged Blood Amylase Increased Health Delusion Professional Hallucination Other Pancreatitis Date:08/02/99ISR Number: 3316659-6Report Type:Expedited (15-DaCompany Report #US-990725435 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa (Olanzapine) PS 2.5MG 1 DAY Hospitalization - Pneumonia Aspiration Professional Initial or Prolonged Respiratory Failure Date:08/02/99ISR Number: 3316660-2Report Type:Expedited (15-DaCompany Report #GBS990703804 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa (Olanzapine) PS 20MG DAY Initial or Prolonged Condition Aggravated Health Obsessive-Compulsive Professional Disorder Other Stress Date:08/02/99ISR Number: 3316662-6Report Type:Expedited (15-DaCompany Report #CA-990600611 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Zyprexa (Olanzapine) PS 10MG DAY Other Risperdal C Date:08/02/99ISR Number: 3316766-8Report Type:Expedited (15-DaCompany Report #US_990725636 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Overdose Professional 24-Jun-2005 12:19 PM Page: 732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/99ISR Number: 3316769-3Report Type:Expedited (15-DaCompany Report #US_990725444 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa (Olanzapine) PS 52.5 MG/DAY Initial or Prolonged Professional Date:08/02/99ISR Number: 3316771-1Report Type:Expedited (15-DaCompany Report #US_990725469 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Health Zyprexa (Olanzapine) PS Initial or Prolonged Overdose Professional Risperdal (Risperidone) C Pepcid (Famotidine) C Wellbutrin 9amfebutamone Hydrochloride) C Prilosec (Omeprazole) C Seroquel C Vanceril (Beclometasone Dipropionate) C Date:08/02/99ISR Number: 3316774-7Report Type:Expedited (15-DaCompany Report #GBS990703810 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Foreign Zyprexa (Olanzapine) PS Health Procyclidine C Professional Date:08/02/99ISR Number: 3317223-5Report Type:Expedited (15-DaCompany Report #DE_990601248 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Zyprexa (Olanzapine) PS 25 MG/DAY Hospitalization - Fall Health Tremarit C Initial or Prolonged Laceration Professional Adalat Retard C Neuroleptic Malignant Other Acc C Syndrome Haldol C Neutropenia Concor C Neutrophil Count Cephalexin C Decreased Overdose Parkinson'S Disease Pneumonia Pyrexia Skin Disorder White Blood Cell Disorder Date:08/02/99ISR Number: 3317226-0Report Type:Expedited (15-DaCompany Report #EWC990603656 Age:47 YR Gender:Male I/FU:F Outcome PT Other Dermatitis Hepatic Enzyme Increased 24-Jun-2005 12:19 PM Page: 733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Pancytopenia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Tegretol C Professional Phenytoin C Other Date:08/02/99ISR Number: 3317228-4Report Type:Expedited (15-DaCompany Report #CA98024381A Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 1100 MG DAY Initial or Prolonged Condition Aggravated Literature Dysarthria Health Hallucination, Auditory Professional Overdose Other Po2 Decreased Sedation Tachycardia Tachypnoea Urinary Incontinence Date:08/02/99ISR Number: 3317489-1Report Type:Expedited (15-DaCompany Report #US_990725118 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Drug Ineffective Study Hallucination Health Paranoia Professional Psychiatric Symptom Suspiciousness Date:08/02/99ISR Number: 3317495-7Report Type:Expedited (15-DaCompany Report #EWC990703772 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Electroconvulsive Therapy Health Remeron C Leukopenia Professional Betaserc C Neutropenia Other Lanzo C Risolid C Levolac C Tenox C Date:08/02/99ISR Number: 3317505-7Report Type:Expedited (15-DaCompany Report #EWC990603730 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa (Olanzapine) PS 25 MG/DAY Neutropenia Health Trilafon C Professional Disipal C Other Sobril C Truxal C 24-Jun-2005 12:19 PM Page: 734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/99ISR Number: 3317519-7Report Type:Expedited (15-DaCompany Report #EWC990202785 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acid Base Balance Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Life-Threatening Abnormal Health Clomipramine C Hospitalization - Arrhythmia Professional Lithium Carbonate C Initial or Prolonged Blood Bicarbonate Other Tegretol C Decreased Blood Creatinine Increased Blood Ph Decreased Blood Urea Increased Cardiac Arrest Heart Rate Abnormal Hepatosplenomegaly Hyperglycaemia Hyperkalaemia Hypotension Liver Disorder Metabolic Acidosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Oxygen Saturation Decreased Respiratory Failure Sedation Date:08/03/99ISR Number: 3316640-7Report Type:Direct Company Report # Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Zyprexa / 5 Mg Initial or Prolonged Professional /Lilly PS Lilly ORAL 5 MG /HS / ORAL Clonazepam / 0.5 Mg SS ORAL 0.5 MG / BID / ORAL Sertraline C Date:08/05/99ISR Number: 3319794-1Report Type:Expedited (15-DaCompany Report #1999-07-1204 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Trilafon Initial or Prolonged Erysipelas Health (Perphenazine) Other Hepatitis C Professional Tablets PS ORAL 16 MG DAILY Myalgia Other ORAL Neuroleptic Malignant Cisordinol Syndrome Injectable SS 10 MG/ML Pyrexia Cisordinol Depot Vomiting Injectable SS 200 MG/ML Zyprexa (Olanzapine) Tablets SS ORAL 15 MG DAILY ORAL Waran Tablets C 24-Jun-2005 12:19 PM Page: 735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/99ISR Number: 3322274-0Report Type:Direct Company Report # Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Zyprexa PS ORAL ORAL Weight Increased Imipramine C Dexidrine C Alderall C Clanzepan C Depracote C Date:08/06/99ISR Number: 3320630-8Report Type:Expedited (15-DaCompany Report #211963 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Other Cellcept Initial or Prolonged Fatigue (Mycophenolate Inappropriate Affect Mofetil) PS ORAL 1 GRAM 2 PER Increased Appetite DAY ORAL Psychotic Disorder Fk506 (Tacrolimus) SS ORAL ORAL Schizophrenia Prednisone Sedation (Prednisone) SS ORAL ORAL Weight Increased Deltasone (Prednisone) SS ORAL 10 MG 1 PER DAY ORAL Zyprexa (Olanzapine) SS PARAVENOUS Atenolol C Procardia C Moduretic C Unicap C Folic Acid C Septra Ds C Dht C Zoloft C Date:08/06/99ISR Number: 3320691-6Report Type:Expedited (15-DaCompany Report #US_990116395 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa (Olanzapine) PS 10 MG/1 AT Initial or Prolonged Asthenia Health BEDTIME Condition Aggravated Professional Prozac (Fluoxetine Hemiparesis Hydrochloride) SS 20 MG/1 IN Infection THE MORNING Multiple Sclerosis Ativan (Lorazepam) C Neutrophil Count Papcid (Famotidine) C Increased Ultram (Tramadol Pain In Extremity Hydrochloride) C Paraesthesia Valium C Tremor White Blood Cell Count Increased Date:08/09/99ISR Number: 3321357-9Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Asthma Hypotension 24-Jun-2005 12:19 PM Page: 736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nasal Dryness Report Source Product Role Manufacturer Route Dose Duration Zyprexa 5 Mg Lilly PS Lilly ORAL 5MG HS ORAL Clonazepam C Fluvoxamine C Trazodone C Pyridoxine C Thiamine C Vitamin E C Date:08/09/99ISR Number: 3321657-2Report Type:Expedited (15-DaCompany Report #US_990725765 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS Initial or Prolonged Pancreatitis Professional Date:08/09/99ISR Number: 3321659-6Report Type:Expedited (15-DaCompany Report #US_990725724 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Consumer Zyprexa Convulsion (Olanzapine) PS 5 MG/2 DAY Loss Of Consciousness Depakote C Muscle Spasms Mellaril C Muscle Twitching Wellbutrin C Cogentin C Date:08/09/99ISR Number: 3321661-4Report Type:Expedited (15-DaCompany Report #US_990725593 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Zyprexa PS 20 MG/1 DAY Professional Date:08/09/99ISR Number: 3321695-XReport Type:Expedited (15-DaCompany Report #DE98014966A Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Haemoglobin Decreased Health Timonil Leukopenia Professional (Carbamazepine) C Platelet Count Decreased Other Date:08/09/99ISR Number: 3321698-5Report Type:Expedited (15-DaCompany Report #AU_990700725 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Olanzapine PS 5 MG/1 DAY Health Codeine Phosphate C Professional Morphine C Diazepam C Temazepam C Paracetamol C Oxazepam C 24-Jun-2005 12:19 PM Page: 737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/99ISR Number: 3321802-9Report Type:Expedited (15-DaCompany Report #DE_990200877 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Initial or Prolonged Extrapyramidal Disorder Health Lorazepam C Hypersensitivity Professional Leukocytosis Other Leukopenia Neutropenia Date:08/09/99ISR Number: 3323128-6Report Type:Expedited (15-DaCompany Report #199920403DDC Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Cholestatic Foreign Glimepiride (Amaryl) Initial or Prolonged Health Tablets PS ORAL 3 MG QD PO 142 DAY Professional Olanzapine (Zyprexa) SS ORAL 5 MG QD PO 211 DAY Other Benorilate (Salipran) SS ORAL 20 MG QD PO 142 DAY Acetylsalicylic Acid C Atenolol C Oxazepam C Date:08/09/99ISR Number: 3323251-6Report Type:Expedited (15-DaCompany Report #US_990724980 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Other Cardiac Arrest Professional Ativan C Circulatory Collapse Sinequan C Coma Clonidine C Drug Interaction Loss Of Consciousness Sudden Death Syncope Vasovagal Date:08/09/99ISR Number: 3323257-7Report Type:Expedited (15-DaCompany Report #US_990623659 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa (Olanzapine) PS Hospitalization - Pancreatitis Acute Professional Depakote C Initial or Prolonged Date:08/09/99ISR Number: 3323261-9Report Type:Expedited (15-DaCompany Report #GBT990400134 Age:32 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Condition Aggravated Delusion Drug Effect Decreased Hallucination Malaise Mental Impairment Psychiatric Symptom Psychotic Disorder 24-Jun-2005 12:19 PM Page: 738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 20 MG DAY Study Health Professional Date:08/09/99ISR Number: 3323264-4Report Type:Expedited (15-DaCompany Report #GBS990603565 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa (Olanzapine) PS 5 MG AT Chills Health BEDTIME Confusional State Professional Sinemet C Electrolyte Imbalance Other Entacapone C Hyperhidrosis Sotalol C Hypertension Diazepam C Leukocytosis Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Parkinsonism Pyrexia Rash Erythematous Tachycardia Urinary Tract Infection Date:08/09/99ISR Number: 3323267-XReport Type:Expedited (15-DaCompany Report #DE_990601295 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Neutrophilia Health Timonil C Professional Other Date:08/10/99ISR Number: 3322908-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Olanzapine PS 5MG @ 0700 + Abnormal Professional 1400, AND 10MG QHS Paroxetine C Dextroamphetamine (Dexedrine) C Trazodone C Date:08/13/99ISR Number: 3324364-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Zyprexa 54mg PS ORAL PO QHS Weight Increased Risperdal 1mg SS ORAL PO TID Effexor C 24-Jun-2005 12:19 PM Page: 739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Neurontin C Date:08/13/99ISR Number: 3325595-0Report Type:Expedited (15-DaCompany Report #8-99193-014A Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Effexor PS ORAL 300 MG DAILY; Initial or Prolonged Distress Syndrome Professional DISCONTINUED Other Asthma IN, JAN. Cardiac Failure 1999, Congestive REINITIATED Dyspnoea Lithium SS ORAL UNKNOWN ORAL Ejection Fraction Temazepam SS ORAL 5 T0 7 DOSES Abnormal DAILY ORAL Gout Zyprexa (Olanzapine) Hypertensive Heart Tablets SS ORAL " AS MUCH AS Disease 25 MG PER Hypoxia DAY" ORAL Oedema Temazepam C Oedema Peripheral Zyprexa C Pulmonary Oedema Lithium C Respiratory Failure Depakote C Sedation Lorazepam C Sleep Apnoea Syndrome Weight Increased Date:08/13/99ISR Number: 3325610-4Report Type:Expedited (15-DaCompany Report #10065282 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Selipran Tabs 20 Mg Initial or Prolonged Hepatitis Health (Pravastatin Sodium) PS ORAL 20 MILLIGRAM, Liver Function Test Professional 1/1 DAY; Abnormal Other ORAL Medication Error Zyprexa (Olanzapine) SS ORAL 5 MILLIGRAM, 1/1 DAY; ORAL Amaryl (Glimepiride) C ORAL 3 MILLIGRAM, 1/1 DAY; ORAL Aspirin C Tenormin C Seresta C Date:08/13/99ISR Number: 3325926-1Report Type:Expedited (15-DaCompany Report #199920403DDC Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Cholestatic Foreign Glimepiride (Amaryl) PS ORAL 3 MG QD PO 142 DAY Initial or Prolonged Health Olanzapine SS ORAL 5 MG QD PO 211 DAY Professional Pravastatin Sodium SS ORAL 20MG QD PO 142 DAY Other Oxazepam (Seresta) C Acetylsalic Acid (Aspirin) C Atenolol (Tenormin) C 24-Jun-2005 12:19 PM Page: 740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/99ISR Number: 3326436-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Olanzapine 25 Mg Od PS ORAL 25 MG OD PO 2 MON Dyspnoea Professional Pulse Absent Syncope Date:08/16/99ISR Number: 3326610-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Triglycerides Zyprexa PS ORAL 10MG PO QD Increased Klonopine C Lipitor C Norvasc C Aspirin C Date:08/16/99ISR Number: 3326726-9Report Type:Expedited (15-DaCompany Report #GBS990703810 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Other Procyclidine C Date:08/16/99ISR Number: 3326737-3Report Type:Expedited (15-DaCompany Report #GBS990703810 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Neuropathy Peripheral Health Procyclidine C Professional Other Date:08/16/99ISR Number: 3326738-5Report Type:Expedited (15-DaCompany Report #US_990724645 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nausea Health Zyprexa (Olanzapine) PS 10 MG/DAY Palpitations Professional Serentil C Vertigo Company Tofranil C Representative Benadryl C Date:08/16/99ISR Number: 3326739-7Report Type:Expedited (15-DaCompany Report #DE_990601256 Age:38 YR Gender:Male I/FU:F Outcome PT Life-Threatening Apnoea Hospitalization - Arrhythmia Initial or Prolonged Brain Hypoxia Disability Electrocardiogram Qt Prolonged Fracture Gaze Palsy Loss Of Consciousness Muscle Spasms 24-Jun-2005 12:19 PM Page: 741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocardial Infarction Nausea Pulse Absent Report Source Product Role Manufacturer Route Dose Duration Shock Foreign Zyprexa (Olanzapine) PS 12.5 MG/DAY Ventricular Fibrillation Health Professional Other Date:08/16/99ISR Number: 3326740-3Report Type:Expedited (15-DaCompany Report #EWC990703797 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Drug Interaction Health Floxyfral C Dyspnoea Professional Madopar C Miosis Other Tegretol C Requip C Theralene C Equanil C Levodopa C Date:08/16/99ISR Number: 3326741-5Report Type:Expedited (15-DaCompany Report #EWC990703810 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Chromaturia Health Tercian C Faeces Pale Professional Hepatitis Other Jaundice Liver Function Test Abnormal Pyrexia Date:08/16/99ISR Number: 3326900-1Report Type:Expedited (15-DaCompany Report #US_990725729 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa (Olanzapine) PS 18 MON Hospitalization - Loss Of Consciousness Professional Prozac (Fluoxetine Initial or Prolonged Neuroleptic Malignant Company Hydrochloride) SS FEW YEARS Syndrome Representative Date:08/16/99ISR Number: 3326910-4Report Type:Expedited (15-DaCompany Report #DE_990801412 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angiopathy Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Cerebral Haemorrhage Health Vitamins C Neonatal Professional Complications Of Maternal Other Exposure To Therapeutic Drugs Convulsion Neonatal Neonatal Respiratory Distress Syndrome 24-Jun-2005 12:19 PM Page: 742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/99ISR Number: 3326912-8Report Type:Expedited (15-DaCompany Report #EWC990703932 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Rivotril C Professional Other Date:08/16/99ISR Number: 3326916-5Report Type:Expedited (15-DaCompany Report #US_990826013 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Disorder Health Zyprexa (Olanzapine) PS 5 MG/DAY Thrombocytopenia Professional Date:08/16/99ISR Number: 3326918-9Report Type:Expedited (15-DaCompany Report #US_990826235 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Foreign Zyprexa (Olanzapine) PS 20 MG/1 DAY 1 YR Polydipsia Health Renal Failure Professional Other Date:08/16/99ISR Number: 3330344-6Report Type:Expedited (15-DaCompany Report #US_990725052 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Iron Deficiency Anaemia Health Prozac Initial or Prolonged Professional (Fluoxetine Hydrochloride) PS 60 MG/DAY Zyprexa (Olanzapine) SS 2.5 MG/DAY 1 MON Depakote C Buspar C Date:08/17/99ISR Number: 3327471-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Amylase Increased Olanzapine Diabetic Ketoacidosis (Zyprexia) PS Eli Lilly Disseminated Intravascular Coagulation Medication Error Pancreatitis Date:08/18/99ISR Number: 3329337-4Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypercholesterolaemia Health Zyprexa 10 Mg PS ORAL 10MG PO QHS 3 MON Intervention to Medication Error Professional Haldol C Prevent Permanent Prozac C Impairment/Damage Ambien C Trilifon C Neurontin C 24-Jun-2005 12:19 PM Page: 743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mvi C Date:08/18/99ISR Number: 3329402-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Zyprexa 10mg Hs PS 10MG HS Intervention to Weight Increased Depakote C Prevent Permanent Hctz C Impairment/Damage Zantac C Mvi C Date:08/18/99ISR Number: 3329480-XReport Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Zyprexa 10mg Po Qd PS ORAL 10MG PO QD Intervention to 10MG PO QD Prevent Permanent Remeron C Impairment/Damage Date:08/23/99ISR Number: 3331943-8Report Type:Expedited (15-DaCompany Report #CA_990800723 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 5MG Initial or Prolonged Balance Disorder Health Digoxin C Blood Bilirubin Increased Professional Celebrex C Cholelithiasis Timolol C Confusional State Loizide C Disorientation Tylenol C Lethargy Liver Function Test Abnormal Memory Impairment Neuroleptic Malignant Syndrome Pyrexia Tremor Urinary Incontinence Date:08/23/99ISR Number: 3332010-XReport Type:Expedited (15-DaCompany Report #DE_990801435 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa (Olanzapine) PS 5 MG DAY 23 WK Bone Marrow Depression Literature Amitriptyline C Depression Health Drug Toxicity Professional Leukopenia 24-Jun-2005 12:19 PM Page: 744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/99ISR Number: 3332351-6Report Type:Expedited (15-DaCompany Report #EWC990804029 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Health Trisekvens C Professional Other Date:08/23/99ISR Number: 3332352-8Report Type:Expedited (15-DaCompany Report #GBS990803899 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Foreign Olanzapine PS 20 MG/DAY Gait Disturbance Health Neuropathy Peripheral Professional Paraesthesia Company Sensory Loss Representative Date:08/23/99ISR Number: 3332353-XReport Type:Expedited (15-DaCompany Report #GBS990803965 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Intestinal Obstruction Health Procyclidine C Professional Other Date:08/23/99ISR Number: 3332354-1Report Type:Expedited (15-DaCompany Report #GBS990803966 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Foreign Zyprexa (Olanzapine) PS 5 MG DAY Other Gastrointestinal Health Venlafaxine C Haemorrhage Professional Digoxin C Rectal Haemorrhage Other Aspirin C Haloperidol C Date:08/25/99ISR Number: 3333961-2Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parotitis Zyprexa 7.5 Mg, Intervention to Swelling Lilly PS Lilly ORAL 15MG PO HS Prevent Permanent Gabapenten C Impairment/Damage Adalat Cc C Lotrimin Cream C Synthroid C Date:08/25/99ISR Number: 3334276-9Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Olanzapine PS 10MG HS Initial or Prolonged Coma Thoridazine SS 50MG HS Drooling Gabapentin C Joint Stiffness Lithium Carb C 24-Jun-2005 12:19 PM Page: 745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/99ISR Number: 3335461-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999000751 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Literature Haldol (Unspecified) Aggression Health (Haloperidol) PS MG, DAILY, Condition Aggravated Professional Olanzapine Drug Interaction (Olanzapine) SS DAILY Medication Error Cogentin C Parkinson'S Disease Depakote C Sedation Axid C Nitroglycerin C Metoprolol C Lisinopril C Aspirin C Date:08/26/99ISR Number: 3334569-5Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Health Valproic Acid PS 500MG PO QAM Liver Function Test Professional + 750MG QHS 8 MON Abnormal Olanzapine SS ORAL PO 7.5 MG Q 6PM Date:08/30/99ISR Number: 3337547-5Report Type:Expedited (15-DaCompany Report #CA_990800726 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Leukopenia Health Loxapine C Neutropenia Professional Clonazepam C Thrombocytopenia Company Lithium C Representative Valproate C Zopicone C Lorazepam C Date:08/30/99ISR Number: 3337549-9Report Type:Expedited (15-DaCompany Report #DE_990300997 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Myeloid Leukaemia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Leukocytosis Health Flunanxol Professional (Flupentixol Dihyrochloride) C Lithium C Truxal (Chlorprothixene Hydrochloride) C Date:08/30/99ISR Number: 3337551-7Report Type:Expedited (15-DaCompany Report #US_990116553 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Study Olanzapine PS 5 MG/1 AT Hospitalization - Injury Health BEDTIME Initial or Prolonged Mania Professional Sorbitol C Speech Disorder Klonopin 24-Jun-2005 12:19 PM Page: 746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Peri-Colace C Aspirin Enteric Coated K.P. (Acetylsalicylic Acid) C Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Date:08/30/99ISR Number: 3337724-3Report Type:Expedited (15-DaCompany Report #US_990826789 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Condition Aggravated Study Drug Ineffective Health Hallucination Professional Psychotic Disorder Suicidal Ideation Suspiciousness Date:08/30/99ISR Number: 3337728-0Report Type:Expedited (15-DaCompany Report #GBS990804018 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Feeding Disorder Premature Baby Date:08/30/99ISR Number: 3337730-9Report Type:Expedited (15-DaCompany Report #US_990826208 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Zyprexa (Olanzapine) PS 50 MG DAY Initial or Prolonged Dehydration Professional Prolixin C Depressed Level Of Lithium C Consciousness Celexa C Drug Level Above Symmetrel C Therapeutic Heat Stroke Leukopenia Pyrexia Date:08/30/99ISR Number: 3337732-2Report Type:Expedited (15-DaCompany Report #US_990826831 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Zyprexa (Olanzapine) PS 15 MG 1 DAY Initial or Prolonged Professional Trazodone C Eskalith C Effexor C Inderal C Promethazine C Morphine C Tylenol C 24-Jun-2005 12:19 PM Page: 747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/99ISR Number: 3337734-6Report Type:Expedited (15-DaCompany Report #US_990826824 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 3 DAY Initial or Prolonged Aminotransferase Literature Clothiapine C Increased Health Blood Creatine Professional Phosphokinase Increased Decreased Activity Psychotic Disorder Rhabdomyolysis Date:08/30/99ISR Number: 3337739-5Report Type:Expedited (15-DaCompany Report #US_990826628 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 10 MG DAY 1 WK Initial or Prolonged Anxiety Literature Clozapine C Cholinergic Syndrome Health Confusional State Professional Disturbance In Attention Dyspnoea Hyperhidrosis Oral Intake Reduced Pneumonia Pyrexia Sleep Disorder Superinfection Tremor Urinary Incontinence Vomiting Date:08/30/99ISR Number: 3337742-5Report Type:Expedited (15-DaCompany Report #AU_990800763 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Olanzapine PS Initial or Prolonged Health Professional Date:08/31/99ISR Number: 3337230-6Report Type:Direct Company Report # Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Valproic Acid PS ORAL 500MG TID Hospitalization - Diarrhoea ORAL Initial or Prolonged Liver Function Test Olanzapine SS ORAL 5MG HS ORAL Other Abnormal Malaise Vomiting Date:08/31/99ISR Number: 3337972-2Report Type:Expedited (15-DaCompany Report #DE_990701351 Age:61 YR Gender:Female I/FU:F Outcome PT Other Cardiomegaly Cyanosis 24-Jun-2005 12:19 PM Page: 748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Pleural Effusion Right Ventricular Failure Report Source Product Role Manufacturer Route Dose Duration Tachycardia Foreign Zyprexa (Olanzapine) PS Weight Increased Health Professional Other Date:08/31/99ISR Number: 3337987-4Report Type:Expedited (15-DaCompany Report #EWC990202778 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged White Blood Cell Count Literature Flurazepam C Decreased Health Professional Other Date:08/31/99ISR Number: 3338004-2Report Type:Expedited (15-DaCompany Report #US_990725435 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Hospitalization - Cardiac Failure Professional Celexa C Initial or Prolonged Chronic Obstructive Depakote C Airways Disease Cardizem C Exacerbated Pneumonia Aspiration Respiratory Failure Date:08/31/99ISR Number: 3338205-3Report Type:Expedited (15-DaCompany Report #US_990725724 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Anger Health Depakote (Valproate Catatonia Professional Semisodium) C Conversion Disorder Cogentin Convulsion (Benzatropine Emotional Disorder Mesilate) C Hyperhidrosis Mellaril Hypotonia (Thioridazine Joint Stiffness Hydrochloride) C Movement Disorder Wellbutrin Muscle Rigidity (Amfebutamone Mutism Hydrochloride) C Sedation Speech Disorder Stress Suicidal Ideation Date:08/31/99ISR Number: 3338208-9Report Type:Expedited (15-DaCompany Report #US_990725729 Age:39 YR Gender:Male I/FU:F Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa (Olanzapine) PS 5 MG/1 DAY 18 MON Phosphokinase Increased Professional Prozac (Fluoxetine Diabetes Mellitus Company Hydrochloride) SS YR Hyperpyrexia Representative Loss Of Consciousness Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Renal Failure Date:09/01/99ISR Number: 3338572-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Olanzapine 25mg Od PS ORAL 25MG OD PO 14 MON Medication Error Professional Pulse Absent Respiratory Arrest Syncope Date:09/02/99ISR Number: 3339938-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999000430 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Risperdal Initial or Prolonged Condition Aggravated Health (Unspecified) Depression Professional (Risperidone) PS SEE IMAGE Infection Olanzapine Medication Error (Olanzapine) SS SEE IMAGE Psychotic Disorder Paroxetine C Restlessness Benztropine C Tremor Clonazepam C Paraxetine C Benztropine C Clonazepam C Flucytosine C Dideoxyinosine C D4t C Saquinavir C Ritonavir C Date:09/03/99ISR Number: 3339449-7Report Type:Direct Company Report # Age:73 YR Gender:Male I/FU:I Outcome PT Blood Creatine Phosphokinase Increased Blunted Affect Diarrhoea Drooling Dyskinesia Extrapyramidal Disorder Feeding Disorder Lung Infiltration 24-Jun-2005 12:19 PM Page: 750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pulse Pressure Abnormal Health Zyprexa 5mg - Lilly PS Lilly ORAL 10MG PO QHS 31 MON Pyrexia Professional Apap C Staring Trazodone C Torticollis Albuterol Inh C Trismus Terazosin C Urinary Incontinence Mom C White Blood Cell Count Clonazepam C Increased Haldol C Date:09/03/99ISR Number: 3339453-9Report Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Health Olanzapine 10mg Intervention to Professional (Zyprexa) PS ORAL 10MG PO 2HS 5 MON Prevent Permanent Trazodone C Impairment/Damage Lisinopril C Vitamin E C Date:09/03/99ISR Number: 3339748-9Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Olanzapine 5 Mg PS ORAL 5 MG PO DAILY Intervention to Neutropenia Prevacid C Prevent Permanent Depakote C Impairment/Damage Mvi C Date:09/07/99ISR Number: 3341260-8Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olanzapine PS Hospitalization - Syndrome Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:09/07/99ISR Number: 3342402-0Report Type:Expedited (15-DaCompany Report #US_990826235 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Foreign Zyprexa (Olanzapine) PS 20 MG/1 DAY 1 YR Polydipsia Health Renal Failure Professional 24-Jun-2005 12:19 PM Page: 751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3342405-6Report Type:Expedited (15-DaCompany Report #EWC990503419 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperphagia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Pancreatitis Necrotising Health Favoxil (Fluvoxamine Pyrexia Professional Maleate) C Weight Increased Date:09/07/99ISR Number: 3342407-XReport Type:Expedited (15-DaCompany Report #US_990623411 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Amylase Increased Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Hospitalization - Coagulopathy Professional Synthroid Initial or Prolonged Diabetes Mellitus (Levothyroxine Other Diabetic Ketoacidosis Sodium) C Embolism Glucophage Hyperglycaemia (Metformin Hypothyroidism Hydrochoride) C Malaise Aspirin C Mental Impairment Pancreatitis Vomiting Date:09/07/99ISR Number: 3342409-3Report Type:Expedited (15-DaCompany Report #US_990725593 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Zyprexa (Olanzapine) PS 20 MG/1 DAY Drug Ineffective Depakote (Valproate Idiopathic Semisodium) C Thrombocytopenic Purpura Klonopin Thrombocytopenia (Clonazepam) C Navane (Tiotixene) C Cogentin (Benzatropine Mesilate) C Lithium C Date:09/07/99ISR Number: 3342704-8Report Type:Expedited (15-DaCompany Report #EWC990804098 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Fontex (Fluoxetine Initial or Prolonged Exposure To Therapeutic Health Hydrochloride) PS Disability Drugs Professional Zyprexa (Olanzapine) SS Congenital Hand Other Atarax C Malformation Premature Baby Date:09/07/99ISR Number: 3342800-5Report Type:Expedited (15-DaCompany Report #EWC990804068 Age:37 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Zyprexa (Olanzapine) PS 15 MG / DAY Phosphokinase Increased Health Catatonia Professional Coma Other Dehydration Disseminated Intravascular Coagulation Hyperpyrexia Leukocytosis Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Quadriplegia Date:09/07/99ISR Number: 3342802-9Report Type:Expedited (15-DaCompany Report #AU_990800771 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Tardive Dyskinesia Foreign Zyprexa (Olanzapine) PS Health Professional Date:09/07/99ISR Number: 3342804-2Report Type:Expedited (15-DaCompany Report #EWC990603612 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa (Olanzapine) PS 20MG / DAY Other Asphyxia Health Nolvadex C Asthenia Professional Zoloft C Cardiac Arrest Other Tranxene C Hepatitis Levothyrox C Hepatocellular Damage Hept-A-Myl C Liver Function Test Duphalac C Abnormal Metastases To Bone Vomiting Date:09/07/99ISR Number: 3342806-6Report Type:Expedited (15-DaCompany Report #US_990826979 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa (Olanzapine) PS 15MG / 1 DAY 1 YR Initial or Prolonged Constipation Professional Anafranil C Intestinal Obstruction Tegretol C Date:09/07/99ISR Number: 3342809-1Report Type:Expedited (15-DaCompany Report #EWC990804093 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Zyprexa (Olanzapine) PS 10MG / DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3342813-3Report Type:Expedited (15-DaCompany Report #US_990826986 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa (Olanzapine) PS 10MG / 1 DAY Health Artane C Professional Inderal C Company Deanxit C Representative Other Date:09/07/99ISR Number: 3342816-9Report Type:Expedited (15-DaCompany Report #US_990827123 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Zyprexa (Olanzapine) PS 7.5 MG / 1 Initial or Prolonged Professional DAY Date:09/07/99ISR Number: 3342819-4Report Type:Expedited (15-DaCompany Report #US_990827187 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Health Zyprexa (Olanzapine) PS 10MG / 1 DAY Diabetes Mellitus Professional Humulin-Human Insulin-Dependent Insulin (Rdna) Unknown Forulation (Human Insulin (Rdna Origin)) SS 35 U / DAY Date:09/07/99ISR Number: 3343768-8Report Type:Expedited (15-DaCompany Report #US_981113149 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Zyprexa (Olanzapine) PS 1 G/DAY Initial or Prolonged Coma Health Condition Aggravated Professional Confusional State Depressed Level Of Consciousness Drug Level Above Therapeutic Drug Toxicity Dry Skin Dysarthria Glycosuria Intentional Misuse Miosis Pupillary Reflex Impaired Respiratory Rate Decreased Sedation Suicide Attempt Tachycardia 24-Jun-2005 12:19 PM Page: 754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3343769-XReport Type:Expedited (15-DaCompany Report #US_981113194 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Literature Zyprexa (Olanzapine) PS 350 MG/DAY Initial or Prolonged Consciousness Health Alcohol C Dysarthria Professional Valproic Acid C Intentional Misuse Miosis Sedation Suicide Attempt Date:09/07/99ISR Number: 3343770-6Report Type:Expedited (15-DaCompany Report #US_990827170 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Health Zyprexa (Olanzapine) PS Initial or Prolonged Confusional State Professional Trihexyphenidyl C Decubitus Ulcer Depressed Level Of Consciousness Drug Toxicity Dysarthria Intentional Misuse Miosis Mucosal Dryness Sedation Suicide Attempt Tachycardia Date:09/07/99ISR Number: 3343771-8Report Type:Expedited (15-DaCompany Report #US_990827160 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Literature Zyprexa (Olanzapine) PS 150 MG/DAY Initial or Prolonged Consciousness Health Dysarthria Professional Intentional Misuse Miosis Sedation Suicide Attempt Tachycardia Date:09/08/99ISR Number: 3342638-9Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Olanzapine 10mg Tab PS ORAL 10MG HSORAL Extrapyramidal Disorder Fluphenazine Hcl C Hallucination Sertraline Hcl C Trifluoperazine Hcl C Date:09/08/99ISR Number: 3342928-XReport Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I Outcome PT Death Abnormal Behaviour Completed Suicide 24-Jun-2005 12:19 PM Page: 755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Family Stress Hypersomnia Report Source Product Role Manufacturer Route Dose Duration Hypertension Consumer Effexor Xr Cap 150 Injury Mg Wyeth Ayerst PS Wyeth Ayerst 300MG 150 Insomnia 2/EACH 6 MON Medication Error Zyprexa Tab 10mg Eli Murder Lilly SS Eli Lilly 10MG AT BED Pneumonia 1 EACH 4 MON Suicidal Ideation Xenical C Thyroid Disorder Premarin C Synthroid C Estratest C Esgic-Plus C Combivent C Date:09/08/99ISR Number: 3343080-7Report Type:Direct Company Report # Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Olanzapine PS ORAL 5 MG QD PO Muscle Rigidity Aricept C Tylenol C Ambien C Zithromax C Colace C Insulin C Nacl Bolus C Date:09/09/99ISR Number: 3343710-XReport Type:Direct Company Report # Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 15MG PO QHS Initial or Prolonged Drug Level Above Professional THIS DRUG AT Therapeutic LEAST 6 MO ON Encephalopathy DRUG SINCE Loss Of Consciousness 1/97 6 MON Miosis Ibuprofen 800 Mg C Pyrexia Tachycardia Date:09/09/99ISR Number: 3343721-4Report Type:Direct Company Report # Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Muscle Rigidity Prolixin Dec. 12.5mg Hospitalization - Muscle Twitching (See Image) PS INTRAMUSCULAR 12.5MG EVERY Initial or Prolonged Pyrexia 3WEEKS IM Zyprexa SS ORAL 5MG PO BID Catapron C Buspar C Cogentin C Eskauth C 24-Jun-2005 12:19 PM Page: 756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/99ISR Number: 3345858-2Report Type:Expedited (15-DaCompany Report #US_990624092 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Electrocardiogram Professional Abnormal Company Representative Date:09/13/99ISR Number: 3345860-0Report Type:Expedited (15-DaCompany Report #US_981214405 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 30 MG DAY Initial or Prolonged Hyperglycaemia Professional Depakote C Lipase Increased Desipramine C Pancreatitis Paxil C Date:09/13/99ISR Number: 3345861-2Report Type:Expedited (15-DaCompany Report #CA_990800723 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Balance Disorder Health Digoxin C Blood Bilirubin Increased Professional Celebrex C Confusional State Timolol C Disorientation Lozide C Lethargy Tylenol C Liver Function Test Abnormal Memory Impairment Neuroleptic Malignant Syndrome Pyrexia Tremor Urinary Incontinence Date:09/13/99ISR Number: 3345862-4Report Type:Expedited (15-DaCompany Report #US_990827160 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Literature Zyprexa (Olanzapine) PS 150 MG/DAY Initial or Prolonged Consciousness Health Drug Level Above Professional Therapeutic Dysarthria Intentional Misuse Miosis Sedation Suicide Attempt Tachycardia Date:09/13/99ISR Number: 3345863-6Report Type:Expedited (15-DaCompany Report #US_990827170 Age:22 YR Gender:Male I/FU:F Outcome PT Hospitalization - Acidosis Initial or Prolonged Anion Gap Increased 24-Jun-2005 12:19 PM Page: 757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Bicarbonate Decreased Blood Creatine Report Source Product Role Manufacturer Route Dose Duration Phosphokinase Increased Literature Zyprexa (Olanzapine) PS Confusional State Health Trihexyphenidyl C Decubitus Ulcer Professional Depressed Level Of Consciousness Drug Level Above Therapeutic Dysarthria Intentional Misuse Miosis Mucosal Dryness Sedation Suicide Attempt Tachycardia Date:09/13/99ISR Number: 3345864-8Report Type:Expedited (15-DaCompany Report #US_990725765 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Initial or Prolonged Pancreatitis Professional Date:09/13/99ISR Number: 3346551-2Report Type:Expedited (15-DaCompany Report #GBS990804126 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Blood Creatine Health Stelazine C Phosphokinase Increased Professional Lofepramine C Blood Sodium Increased Other Blood Urea Increased Neuroleptic Malignant Syndrome Pyrexia Renal Failure Acute Sepsis Date:09/13/99ISR Number: 3346554-8Report Type:Expedited (15-DaCompany Report #GBS990904138 Age:40 YR Gender:Male I/FU:I Outcome PT Death Blood Creatinine Hospitalization - Increased Initial or Prolonged Blood Glucose Increased Blood Ph Decreased Blood Urea Increased Cardiac Arrest Coma Hepatic Steatosis Hepatomegaly Hyperglycaemia Ketoacidosis Malaise Overdose Sedation 24-Jun-2005 12:19 PM Page: 758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Paroxetine C Professional Clonazepam C Company Alprazolam C Representative Lithium C Other Carbonate C Date:09/13/99ISR Number: 3346558-5Report Type:Expedited (15-DaCompany Report #US_990927564 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa (Olanzapine) PS Exposure To Therapeutic Professional Paxil C Drugs Company Remeron C Foetal Arrhythmia Representative Neonatal Respiratory Distress Syndrome Date:09/13/99ISR Number: 3346559-7Report Type:Expedited (15-DaCompany Report #CA_990800772 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Fall Health Lorazepam C Female Sexual Arousal Professional Colace C Disorder Company Hypertensive Crisis Representative Speech Disorder Other Tachycardia Date:09/13/99ISR Number: 3346561-5Report Type:Expedited (15-DaCompany Report #US_990725761 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Zyprexa (Olanzapine) PS 20 MG/DAY Leukopenia Professional Zoloft C White Blood Cell Count Norvasc C Abnormal Atenolol C Charcoal Activated C Date:09/13/99ISR Number: 3346564-0Report Type:Expedited (15-DaCompany Report #DE_990901502 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 40 MG/DAY 9 DAY Initial or Prolonged Extrapyramidal Disorder Literature Risperidone C Neutrophil Count Health Benperidol C Decreased Professional Psychotic Disorder Pyrexia Schizophrenia White Blood Cell Disorder 24-Jun-2005 12:19 PM Page: 759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/99ISR Number: 3346721-3Report Type:Expedited (15-DaCompany Report #US_990725007 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amblyopia Literature Prozac(Fluoxetine Balanitis Health Hydrochloride) PS 60 MG/DAY Diabetes Mellitus Professional Zyprexa(Olanzapine) SS 10 MG/DAY Diabetes Mellitus Humulin-Human Nph Inadequate Control Insulin (Rdna) Fungal Infection (Human Insulin (Rdna Hallucination, Auditory Origin)) SS 45 U/2 DAY Hypercholesterolaemia Humulin-Human Hyperglycaemia Regular Insulin Hyperlipidaemia (Rdna) (Human Hypertriglyceridaemia Insulin (Rdna Oedema Origin)) SS Parkinson'S Disease Glyburide C Polydipsia Polyuria Weight Increased Date:09/14/99ISR Number: 3347329-6Report Type:Expedited (15-DaCompany Report #B0070412A Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Zantac (Formulation Hospitalization - Rash Generalised Unknown ) Initial or Prolonged Rash Maculo-Papular (Ranitidine Toxic Epidermal Hydrochloride) PS ORAL ORAL Necrolysis Valproate Sodium (Formulation Unknown) (Valproate Sodium) SS ORAL ORAL Carbamazepine SS ORAL ORAL Cyamemazine (Formulation Unknown) (Cyamemazine) SS ORAL ORAL Olanzepine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Zolpidem (Formulation Unknown) (Zolpidem) SS ORAL ORAL Date:09/17/99ISR Number: 3350104-XReport Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Olanzapine 10 Mg PS ORAL 20MG PO QHS Initial or Prolonged Dystonia Tachycardia 24-Jun-2005 12:19 PM Page: 760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/99ISR Number: 3350358-XReport Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Clonazepam 2 Mg PS ORAL 2 MG PO TID Initial or Prolonged Overdose Olanzapine 10 Mg SS ORAL 10 MG PO Q HS Sedation Atrovent Inhaler C Hydroxyzine C Vitamin E C Gabapentin C Cyproheptadine C Buspar C Temazepam C Date:09/20/99ISR Number: 3352011-5Report Type:Expedited (15-DaCompany Report #EWC990904133 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Health Largactil C Professional Other Date:09/20/99ISR Number: 3352374-0Report Type:Expedited (15-DaCompany Report #EWC990904129 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Mucous Membrane Disorder Foreign Zyprexa (Olanzapine) PS Hospitalization - Skin Lesion Health Azantac C Initial or Prolonged Toxic Epidermal Professional Tegretol C Necrolysis Other Tercian C Date:09/20/99ISR Number: 3352388-0Report Type:Expedited (15-DaCompany Report #US_990927849 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 15 MG/1 AT Initial or Prolonged Encephalopathy Professional BEDTIME Loss Of Consciousness Ibuprofen C Miosis Pyrexia Tachycardia Date:09/20/99ISR Number: 3352410-1Report Type:Expedited (15-DaCompany Report #GBS990603461 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Lymphocyte Count Health Lithium C Decreased Professional Monocyte Count Decreased Neutrophil Count Decreased Platelet Count Decreased Sedation White Blood Cell Count Decreased 24-Jun-2005 12:19 PM Page: 761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3352542-8Report Type:Expedited (15-DaCompany Report #US_990115843 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Literature Zyprexa (Olanzapine) PS 10 MG/1 DAY Hospitalization - Disseminated Health Synthroid C Initial or Prolonged Intravascular Coagulation Professional Klonopin C Other Drug Withdrawal Propranolol C Convulsions Hyperkalaemia Hypotension Ivth Nerve Paralysis Leukocytosis Medication Error Metabolic Acidosis Myocardial Infarction Pupil Fixed Pyrexia Rhabdomyolysis Screaming Status Epilepticus Tachycardia Date:09/20/99ISR Number: 3352662-8Report Type:Expedited (15-DaCompany Report #DE_990200877 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Initial or Prolonged Drug Hypersensitivity Literature Lorazepam C Leukocytosis Health Risperidone C Leukopenia Professional Benperidol C Neutropenia Pyrexia Date:09/20/99ISR Number: 3352668-9Report Type:Expedited (15-DaCompany Report #GBS990603565 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa (Olanzapine) PS 5 MG AT Blood Creatine Health BEDTIME Phosphokinase Increased Professional Sinemet C Chills Other Entacapone C Confusional State Sotalol C Electrolyte Imbalance Diazepam C Hyperhidrosis Hyperpyrexia Hypertension Leukocytosis Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Parkinson'S Disease Rash Erythematous Tachycardia Urinary Tract Infection 24-Jun-2005 12:19 PM Page: 762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3352675-6Report Type:Expedited (15-DaCompany Report #EWC980400332 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arthralgia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Arthritis Literature Nozinan C Initial or Prolonged Bradycardia Health Tegretol C Bundle Branch Block Right Professional Xanax C C-Reactive Protein Mopral C Increased Nifluril C Cardiac Arrest Coma Disseminated Intravascular Coagulation Gastritis Hepatic Failure Hiatus Hernia Hypothermia Joint Swelling Lung Disorder Pneumonia Aspiration Red Blood Cell Sedimentation Rate Increased Renal Failure Acute Rhabdomyolysis Shock Temperature Regulation Disorder Date:09/20/99ISR Number: 3352714-2Report Type:Expedited (15-DaCompany Report #US_990927736 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa(Olanzapine) PS 20 MG Initial or Prolonged Aggression Study Valproic Acid C Condition Aggravated Health Risperidone C Delusion Professional Drug Ineffective Other Hallucination Hostility Psychotic Disorder Date:09/20/99ISR Number: 3352718-XReport Type:Expedited (15-DaCompany Report #DE_990901499 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Zyprexa(Olanzapine) PS 10 MG/DAY Initial or Prolonged Pancreatitis Acute Health Vomiting Professional Other Date:09/20/99ISR Number: 3353006-8Report Type:Expedited (15-DaCompany Report #US_990927865 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Zyprexa (Olanzapine) PS 10 MG Therapeutic Intentional Misuse 24-Jun-2005 12:19 PM Page: 763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3353010-XReport Type:Expedited (15-DaCompany Report #US_990927738 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Zyprexa (Olanzapine) PS Initial or Prolonged Drug Toxicity Professional Lithium C Hepatic Failure Company Haldol (Haloperidol) C Representative Date:09/20/99ISR Number: 3353013-5Report Type:Expedited (15-DaCompany Report #GBS990904153 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Pilonidal Cyst Health Weight Increased Professional Company Representative Date:09/20/99ISR Number: 3353016-0Report Type:Expedited (15-DaCompany Report #GBS990904204 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 2.5 MG 4 DAY Initial or Prolonged Logorrhoea Health Lustral (Sertraline Mania Professional Hydrochloride) C Date:09/21/99ISR Number: 3352710-5Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Olanzapine PS 10MG BID Initial or Prolonged Valproic Acid SS 500 BID Divalpreen C Asa C Date:09/24/99ISR Number: 3356736-7Report Type:Direct Company Report # Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypersomnia Health Zyprexa 5mg Tablet - Intervention to Sedation Professional Lilly PS Lilly 5MG GIVEN Prevent Permanent ONCE Impairment/Damage Diabinese C Monopril C Lasix C Asa C Date:09/27/99ISR Number: 3358760-7Report Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I Outcome PT Life-Threatening Abdominal Pain Upper Hospitalization - Aggression Initial or Prolonged Anger Disability Chest Discomfort Dyspnoea 24-Jun-2005 12:19 PM Page: 764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eye Pain Insomnia Irritability Report Source Product Role Manufacturer Route Dose Duration Night Cramps Luvox-Eli Lilly Pollakiuria Company PS Eli Lilly Company Pruritus Zyprexa-Solvay Company SS Solvay Company Date:09/27/99ISR Number: 3358956-4Report Type:Expedited (15-DaCompany Report #GBS990904304 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa (Olanzapine) PS Exposure To Therapeutic Health Drugs Professional Congenital Anomaly Other Talipes Date:09/27/99ISR Number: 3359182-5Report Type:Expedited (15-DaCompany Report #US_990927856 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Professional Lithium C Trazodone C Klonopin C Date:09/27/99ISR Number: 3359186-2Report Type:Expedited (15-DaCompany Report #GBS990904226 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Foreign Olanzapine PS 12. 5 MG DAY Initial or Prolonged Health Professional Date:09/27/99ISR Number: 3359218-1Report Type:Expedited (15-DaCompany Report #EWC990904265 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Health Deroxat C Professional Xanax C Company Representative Other Date:09/27/99ISR Number: 3359222-3Report Type:Expedited (15-DaCompany Report #GBS990804070 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa (Olanzapine) PS 125 MG/1 DAY Initial or Prolonged Mental Disorder Health Paroxetine C Other Professional Other 24-Jun-2005 12:19 PM Page: 765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/99ISR Number: 3359227-2Report Type:Expedited (15-DaCompany Report #US_990928378 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Consumer Zyprexa (Olanzapine) PS 20 MG/1 DAY Blood Prolactin Increased Valium C Breast Neoplasm Vistaril C Condition Aggravated Date:09/27/99ISR Number: 3359232-6Report Type:Expedited (15-DaCompany Report #US_990928114 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Zyprexa (Olanzapine) PS 15 MG/1 AT Initial or Prolonged Diabetic Ketoacidosis Professional BEDTIME Hyperglycaemia Company Inderal C Mucosal Dryness Representative Sertraline C Pancreatitis Buspirone C Polydipsia Polyuria Tachycardia Vomiting Date:09/27/99ISR Number: 3359236-3Report Type:Expedited (15-DaCompany Report #US_990928327 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 40 MG/1 DAY Initial or Prolonged Loss Of Consciousness Professional Prilosec C Respiratory Depression Date:09/27/99ISR Number: 3359239-9Report Type:Expedited (15-DaCompany Report #GBS990904231 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Olanzapine PS 20 MG/DAY Condition Aggravated Health Imipramine C Electrocardiogram Qt Professional Senna C Prolonged Other Quetiapine C Palpitations Date:09/27/99ISR Number: 3359243-0Report Type:Expedited (15-DaCompany Report #GBS990904268 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Foreign Zyprexa (Olanzapine) PS White Blood Cell Count Health Increased Professional Other Date:09/27/99ISR Number: 3359245-4Report Type:Expedited (15-DaCompany Report #CA_990600578 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Oedema Foreign Initial or Prolonged Pain Health Professional 24-Jun-2005 12:19 PM Page: 766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa(Olanzapine) PS 10 MG/AT BEDTIME 6 WK Wellbutrin Sr C Somnol C Visken C Prozac C Date:09/27/99ISR Number: 3359247-8Report Type:Expedited (15-DaCompany Report #EWC990503419 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compulsions Foreign Zyprexa(Olanzapine) PS 20 MG/DAY Initial or Prolonged Hyperphagia Health Favoxil C Pancreatitis Necrotising Professional Pyrexia Other Weight Increased Date:09/27/99ISR Number: 3359251-XReport Type:Expedited (15-DaCompany Report #US_990116553 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Study Olanzapine PS 15 MG/1 AT Hospitalization - Aggression Health BEDTIME Initial or Prolonged Agitation Professional Sorbitol C Fall Klonopin C Mania Peri-Colace C Pressure Of Speech Aspirin Enteric Coated K.P. C Depakote C Ativan C Date:09/27/99ISR Number: 3359255-7Report Type:Expedited (15-DaCompany Report #US_990826986 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa(Olanzapine) PS 10 MG/1 DAY Health Artane C Professional Inderal C Company Deanxit C Representative Other Date:09/27/99ISR Number: 3359671-3Report Type:Expedited (15-DaCompany Report #EWC990703772 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Leukopenia Health Remeron C Major Depression Professional Betaserc C Other Lanzo C Risolid C Levolac C Tenox C 24-Jun-2005 12:19 PM Page: 767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/99ISR Number: 3360129-6Report Type:Expedited (15-DaCompany Report #EWC990904233 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Other Date:09/27/99ISR Number: 3360131-4Report Type:Expedited (15-DaCompany Report #EWC990904235 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Olanzapine PS 20 MG/DAY Initial or Prolonged Cardiac Failure Health Cardiomyopathy Professional Date:09/27/99ISR Number: 3360132-6Report Type:Expedited (15-DaCompany Report #EWC990904253 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inappropriate Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Antidiuretic Hormone Health Secretion Professional Other Date:09/27/99ISR Number: 3360135-1Report Type:Expedited (15-DaCompany Report #US_990928019 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Zyprexa (Olanzapine) PS Intentional Self-Injury Prozac (Fluoxetine Hydrochloride) SS Date:09/27/99ISR Number: 3360137-5Report Type:Expedited (15-DaCompany Report #EWC990904200 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Jaundice Health Seroxat (Paroxetine Liver Function Test Professional Hydrochloride) C Abnormal Company Xanax (Alprazolam) C Representative Other Date:09/27/99ISR Number: 3360138-7Report Type:Expedited (15-DaCompany Report #EWC990904229 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gamma-Glutamyltransferase Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Increased Health Stilnox (Zolpidem) C Hepatitis Professional Jaundice Other 24-Jun-2005 12:19 PM Page: 768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/99ISR Number: 3367091-0Report Type:Periodic Company Report #A001-002-003428 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Aricept (Donepezil) PS ORAL 2.5MG (1 IN 1 Hyperhidrosis Professional D),PER ORAL;5 MG (1 IN 1 D), PER ORAL; 10 MG (1 IN 1 Zyprexa (Olanzapine) SS ORAL 2.5 MG (1 IN 1 D), PER ORAL; 5 MG (1 IN 1 D), PER ORAL Miacalcin (Calcitonin, Salmon) C Vitamin E (Tocopherol) C Corgard (Nadolol) C Date:09/28/99ISR Number: 3358816-9Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Health Olanzapine 5 Mg Qhs PS 5MG QHS Intervention to Professional Nph/R Insulin Prevent Permanent (70/30) C Impairment/Damage Celexa C Benadryl C Date:09/28/99ISR Number: 3364804-9Report Type:Periodic Company Report #USA009865 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Central Nervous System Consumer Meridia PS ORAL 15 MG OD PO Stimulation Vicodin SS ORAL 5 MG TID PO Sedation Celexa SS ORAL 40 MG OD PO Diovan SS ORAL 80 MG OD PO Detrol SS ORAL 2 MG BID PO Lipitor SS ORAL 10 MG OD PO Zyprexa SS ORAL 5 MG NOCTE PO Date:10/01/99ISR Number: 3392471-7Report Type:Periodic Company Report #US_981113074 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Insomnia Health Placebo SS Professional Hydroxyzine C Trazodone C Ativan C Hydrochlorothiazide C Olanzapine C Divalproex Sodium C Multivitamins C Lorazepam C Vitamin E C Ativan C 24-Jun-2005 12:19 PM Page: 769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/99ISR Number: 3362383-3Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Prolactin Increased Zyprexa 5mg PS ORAL 1 TABLET PO Intervention to Gynaecomastia BID Prevent Permanent Remeron C Impairment/Damage Paxil C Date:10/04/99ISR Number: 3363492-5Report Type:Expedited (15-DaCompany Report #EWC990904316 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Life-Threatening Fall Health Loxapac C Hospitalization - Heat Stroke Professional Initial or Prolonged Pallor Company Pyrexia Representative Tachypnoea Date:10/04/99ISR Number: 3363495-0Report Type:Expedited (15-DaCompany Report #EWC990904294 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Olanzapine PS 10 MG/DAY Life-Threatening Phosphokinase Increased Health Fluanxol C Hospitalization - Catatonia Professional Temesta C Initial or Prolonged Condition Aggravated Dalmadorm C Drug Toxicity Hypertension Muscle Rigidity Negativism Neuroleptic Malignant Syndrome Overdose Pulmonary Embolism Pyrexia Stereotypy Stupor Tachycardia White Blood Cell Disorder Date:10/04/99ISR Number: 3363541-4Report Type:Expedited (15-DaCompany Report #US_990929012 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Health Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Premature Separation Of Professional Zoloft (Sertraline Placenta Hydrochloride) C Date:10/04/99ISR Number: 3363561-XReport Type:Expedited (15-DaCompany Report #GBS990403152 Age:39 YR Gender:Male I/FU:F Outcome PT Death Coronary Artery Disease Drug Level Above Therapeutic Haemorrhage 24-Jun-2005 12:19 PM Page: 770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Misuse Liver Disorder Pulmonary Congestion Report Source Product Role Manufacturer Route Dose Duration Renal Disorder Foreign Olanzapine PS Urine Analysis Abnormal Health Procyclidine C Ventricular Hypertrophy Professional Haloperidol C Other Diazepam C Propranolol C Date:10/04/99ISR Number: 3363562-1Report Type:Expedited (15-DaCompany Report #US_990826208 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Zyprexa (Olanzapine) PS 50 MG / DAY Initial or Prolonged Depressed Level Of Professional Prolixin Consciousness (Fluphenazine Feeling Hot Hydrochloride) C Heat Stroke Lithium C Hyperpyrexia Celexa (Citalopram Leukopenia Hydrobromide) C Mental Impairment Symmetrel Neuroleptic Malignant (Amantadine Syndrome Hydrochloride) C Syncope White Blood Cell Count Decreased Date:10/04/99ISR Number: 3363564-5Report Type:Expedited (15-DaCompany Report #US_981214405 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa (Olanzapine) PS 30 MG /DAY Initial or Prolonged Anorexia Professional Depakote (Valproate Ascites Semisodium) C Blood Glucose Increased Desipramine C Blood Ketone Body Paxil (Paroxetine Increased Hydrochloride) C Blood Ph Decreased Blood Triglycerides Increased Diabetes Mellitus Diabetic Ketoacidosis Emotional Distress Haemoglobin Decreased Ileus Paralytic Liver Function Test Abnormal Pancreatitis Pco2 Decreased Polydipsia Polyuria Respiratory Rate Increased Tachycardia Vomiting 24-Jun-2005 12:19 PM Page: 771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/99ISR Number: 3363805-4Report Type:Expedited (15-DaCompany Report #EWC980400445 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Hyperglycaemia Literature Initial or Prolonged Respiratory Disorder Health Professional Date:10/06/99ISR Number: 3365374-1Report Type:Direct Company Report # Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Olanzapine (Zyprexa)-Lilly. PS Lilly ORAL 20MG PO DAILY Date:10/07/99ISR Number: 3365579-XReport Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Zyprexa PS ORAL 5MG Q HS (PO) Initial or Prolonged Drug Level Above Depacote SS ORAL 750MG IA, 750 Therapeutic MG SP, PO Pneumonia 100MG Date:10/07/99ISR Number: 3365610-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vision Blurred Olanzapine PS 10MG BID Date:10/12/99ISR Number: 3370060-8Report Type:Expedited (15-DaCompany Report #DE_990901544 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG 2 DAY Initial or Prolonged Neutrophil Count Health Haldol (Haloperidol) C Decreased Professional Faustan (Diazepam) C Date:10/12/99ISR Number: 3370063-3Report Type:Expedited (15-DaCompany Report #EWC990904328 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa (Olanzapine) PS Health Professional Date:10/12/99ISR Number: 3370150-XReport Type:Expedited (15-DaCompany Report #EWC980400445 Age:24 YR Gender:Male I/FU:F Outcome PT Death Abdominal Rigidity Hospitalization - Asthenia Initial or Prolonged Atrioventricular Block Other Blood Glucose Abnormal Blood Glucose Increased 24-Jun-2005 12:19 PM Page: 772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Cardiac Failure Electrolyte Imbalance Report Source Product Role Manufacturer Route Dose Duration Extensor Plantar Response Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hyperventilation Literature Haloperidol C Hypoxia Health Lorazepam C Ketoacidosis Professional Metabolic Acidosis Other Nausea Pallor Pneumothorax Polydipsia Sedation Tachycardia Tachypnoea Date:10/12/99ISR Number: 3370156-0Report Type:Expedited (15-DaCompany Report #CA_990700654 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa (Olanzapine) PS 200 MG Hospitalization - Dystonia Health Ativan (Lorazepam) C Initial or Prolonged Emotional Disorder Professional Influenza Other Overdose Pulmonary Oedema Date:10/12/99ISR Number: 3370158-4Report Type:Expedited (15-DaCompany Report #EWC990904200 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Body Temperature Health Seroxat (Paroxetine Initial or Prolonged Decreased Professional Hydrochloride) C Chest X-Ray Abnormal Company Xanax (Alprazolam) C Chromaturia Representative Regulan (Psyllium Colitis Other Hydrophilic Dermatitis Mucilloid) C Dizziness Sural (Ethambutol Hypoaesthesia Dihydrochloride) C Jaundice Pyrazinamide C Liver Function Test Abnormal Nausea Red Blood Cell Sedimentation Rate Increased Sedation Urine Amylase Increased Date:10/12/99ISR Number: 3370161-4Report Type:Expedited (15-DaCompany Report #EWC990904265 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Death Completed Suicide Foreign Condition Aggravated Health Professional Company 24-Jun-2005 12:19 PM Page: 773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 15 MG Deroxat (Paroxetine Hydrochloride) C Tercian (Cyamemazine) C Tegretol (Carbamazepine) C Date:10/12/99ISR Number: 3370165-1Report Type:Expedited (15-DaCompany Report #EWC990904351 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine PS 15 MG/DAY Initial or Prolonged Phosphokinase Increased Health Diazepam C Other Condition Aggravated Professional Droperidol C Liver Function Test Other Abnormal Muscle Rigidity Neuroleptic Malignant Syndrome Psychotic Disorder Tremor Date:10/12/99ISR Number: 3370166-3Report Type:Expedited (15-DaCompany Report #EWC991004403 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine PS 10 MG/DAY 5 MON Intentional Self-Injury Health Sedation Professional Other Date:10/12/99ISR Number: 3370168-7Report Type:Expedited (15-DaCompany Report #US_990929044 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Zyprexa (Olanzapine) PS 3 MON Optic Neuritis Date:10/12/99ISR Number: 3370468-0Report Type:Expedited (15-DaCompany Report #US_990927738 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Zyprexa (Olanzapine) PS Initial or Prolonged Drug Interaction Professional Lithium C Drug Level Above Company Haldol (Haloperidol) C Therapeutic Representative Neurontin Drug Toxicity (Gabapentin) C Hepatic Failure Parkinson'S Disease 24-Jun-2005 12:19 PM Page: 774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3370743-XReport Type:Expedited (15-DaCompany Report #US_990929125 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1DAY Drug Interaction Professional Dilantin (Phenytoin Drug Level Below Sodium) C Therapeutic Mellaril (Thioridazine Hydrochloride) C Date:10/12/99ISR Number: 3370749-0Report Type:Expedited (15-DaCompany Report #US_991029164 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa (Olanzapine) PS Therapeutic Professional Date:10/15/99ISR Number: 3374150-5Report Type:Expedited (15-DaCompany Report #9942708 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Norvasc PS ORAL 5.00 MG Initial or Prolonged Leukopenia Professional TOTAL:DAILY:O Required Schizophrenia RAL Intervention to Olanzapine SS Prevent Permanent Atenolol C Impairment/Damage Date:10/18/99ISR Number: 3374772-1Report Type:Expedited (15-DaCompany Report #US_991029337 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS Initial or Prolonged Hypothermia Professional Mental Impairment Date:10/18/99ISR Number: 3374774-5Report Type:Expedited (15-DaCompany Report #US_991029315 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Initial or Prolonged Delusion Professional Hallucination Company Mania Representative Date:10/18/99ISR Number: 3374776-9Report Type:Expedited (15-DaCompany Report #US_991029297 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 5MG/1 DAY Initial or Prolonged Drug Toxicity Professional Bactrim C Hypothermia Lithium C Muscle Rigidity Trazodone C 24-Jun-2005 12:19 PM Page: 775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/99ISR Number: 3374778-2Report Type:Expedited (15-DaCompany Report #DE_990801445 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Syndrome Health Lithium C Pneumonia Primary Professional Carbamazepine C Atypical Other Euthyrox (Levothyroxine Sodium) C Date:10/18/99ISR Number: 3374780-0Report Type:Expedited (15-DaCompany Report #AU_991000818 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Olanzapine PS 150 MG Initial or Prolonged Overdose Health Sedation Professional Other Date:10/18/99ISR Number: 3374781-2Report Type:Expedited (15-DaCompany Report #GBS991004389 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/AT Pancytopenia Health BEDTIME White Blood Cell Count Professional Decreased Other Date:10/18/99ISR Number: 3375158-6Report Type:Expedited (15-DaCompany Report #GBS991004432 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Prolonged Health Zolpidem C Intentional Misuse Professional Trimipramine C Myocardial Infarction Other Ventricular Hypertrophy Date:10/18/99ISR Number: 3375159-8Report Type:Expedited (15-DaCompany Report #GBS991004397 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Diarrhoea Health Erythromycin Professional (Asymptomatic) C Other Date:10/18/99ISR Number: 3375216-6Report Type:Expedited (15-DaCompany Report #US_990927849 Age:55 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Alkaline Initial or Prolonged Phosphatase Increased Coma Drug Level Above Therapeutic 24-Jun-2005 12:19 PM Page: 776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Encephalopathy Loss Of Consciousness Miosis Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa (Olanzapine) PS 15 MG/1 AT Tachycardia Professional BEDTIME Other Ibuprofen C Date:10/18/99ISR Number: 3375218-XReport Type:Expedited (15-DaCompany Report #US_990826979 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Constipation Professional Anafranil C Megacolon Tegretol C Small Intestinal Obstruction Date:10/18/99ISR Number: 3375689-9Report Type:Expedited (15-DaCompany Report #CA_990600621 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Olanzapine PS 5 MG/ 1 DAY Initial or Prolonged Intentional Misuse Study Psychotic Disorder Health Professional Date:10/18/99ISR Number: 3375690-5Report Type:Expedited (15-DaCompany Report #EWC990904351 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine PS 15 MG/DAY Initial or Prolonged Phosphokinase Increased Health Diazepam C Other Condition Aggravated Professional Droperidol C Liver Function Test Abnormal Muscle Rigidity Neuroleptic Malignant Syndrome Psychotic Disorder Pyrexia Tremor Date:10/18/99ISR Number: 3375692-9Report Type:Expedited (15-DaCompany Report #US_990928327 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphasia Health Zyprexa (Olanzapine) PS 40 MG/1 DAY Hospitalization - Coma Professional Prilosec(Omeprazole) C Initial or Prolonged Loss Of Consciousness Medication Error Sedation 24-Jun-2005 12:19 PM Page: 777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/99ISR Number: 3375713-3Report Type:Expedited (15-DaCompany Report #1999UW03215 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel "Zeneca" PS Zeneca Drug Toxicity Professional Bupropion SS Intentional Misuse Olanzapine SS Carbamazepine SS Pramoxine SS Date:10/18/99ISR Number: 3375757-1Report Type:Expedited (15-DaCompany Report #GBS981202090 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa (Olanzapine) PS 15 MG/1 DAY 1 YR Brain Hypoxia Consumer Cardiac Failure Health Cerebral Ischaemia Professional Circulatory Collapse Company Difficulty In Walking Representative Fall Other Fatigue Gait Disturbance Gliosis Hepatic Fibrosis Hepatic Steatosis Increased Appetite Injury Logorrhoea Loss Of Consciousness Overdose Paraesthesia Pulmonary Oedema Weight Increased Date:10/18/99ISR Number: 3375759-5Report Type:Expedited (15-DaCompany Report #DE_990901568 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Tachycardia Health Truxal Professional (Chloprothixene Other Hydrochloride) C Date:10/18/99ISR Number: 3375760-1Report Type:Expedited (15-DaCompany Report #US_991029509 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Swelling Professional Risperdal Urticaria (Risperidone) C Date:10/19/99ISR Number: 3376142-9Report Type:Expedited (15-DaCompany Report #210415 Age:17 YR Gender:Male I/FU:F Outcome PT Other Chest Pain Condition Aggravated 24-Jun-2005 12:19 PM Page: 778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delusional Disorder, Persecutory Type Fatigue Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Consumer Cellcept Paraesthesia Health (Mycophenolate Psychotic Disorder Professional Mofetil) PS ORAL 1000 MG 2 PER Schizophrenia DAY ORAL Sedation Deltasone Weight Increased (Prednisone) SS ORAL 10 MG DAILY ORAL Fk506 (Tacrolimus) SS ORAL ORAL Zyprexa (Olanzapine) SS PARAVENOUS Prednisone (Prednisone) SS ORAL ORAL Prograf (Tacrolimus) C Atenolol (Atenolol) C Procardia (Nifedipine) C Moduretic (Amiloride Hydrochloride/Hydroc hlorothiazide) C Unicap (Ascorbic Acid/Cholecalciferol /Folic Acid/Vitamin A/Vitamin B Complex/ Vitamin E) C Folic Acid (Folic Acid) C Septra Ds (Sulfamethoxazole/Tr imethoprim) C Dht (Dihydrotachysterol) C Zoloft (Sertraline Hydrochloride) C Sk-65 (Propoxyphene Hydrochloride) C Date:10/20/99ISR Number: 3376264-2Report Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Zyprexa 5mg Lilly PS Lilly ORAL 5 MG HS ORAL Valproic Acid C Clonazepam C Date:10/20/99ISR Number: 3376667-6Report Type:Expedited (15-DaCompany Report #211963 Age:15 YR Gender:Male I/FU:F Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Delusion Disorientation Dissociation Drug Ineffective Fatigue Hallucination, Auditory Inappropriate Affect Increased Appetite 24-Jun-2005 12:19 PM Page: 779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Schizophrenia Sedation Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Other Cellcept Weight Increased (Mycophenolate Mofetil) PS ORAL 1 GRAM 2 PER DAY ORAL Fk506 (Tacrolimus) SS ORAL ORAL Prednisone (Prednisone) SS ORAL ORAL Deltasone (Prednisone) SS ORAL 10 MG 1 PER DAY ORAL Zyprexa (Olanzapine) SS PARAVENOUS Atenolol (Atenolol) C Procardia (Nifedipine) C Moduretic (Amiloride Hydrochloride/Hydroc hlorothiazide) C Unicap (Ascorbic Acid/Cholecalciferol /Folic Acid/Vitamin A/Vitamin B Complex/Vitamin E) C Folic Acid (Folic Acid) C Septra Ds (Sulfamethoxazole/Tr imethoprim) C Dht (Dihydrotachysterol) C Zoloft (Sertraline Hydrochloride) C Date:10/21/99ISR Number: 3376600-7Report Type:Direct Company Report # Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Olanzapine(Zyprexa)2 0mgpohs Managementof Psychotic Disorder PS Date:10/21/99ISR Number: 3376620-2Report Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Olanzapine(Zyprexa) PS ORAL 20 MG PO 4 PM Professional Date:10/21/99ISR Number: 3376629-9Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephritis Health Levaquin 500mg Professional (Ortho-Mcneil) PS Ortho-Mcneil ORAL 500 MG ORAL QD 14 DAY Zyprexa 2.5mg 24-Jun-2005 12:19 PM Page: 780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lilly) SS Lilly ORAL 2.5 MG ORAL QHS 10 DAY Digoxin C Vasotec C Pepcid C Guaifenesin C Lorazepam C Metronidazole C Furosemide C Vancomycin C Date:10/22/99ISR Number: 3377622-2Report Type:Periodic Company Report #98784.01 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Diazepam Tablets 5 Hypoaesthesia Mg PS ORAL 5 MG (ONE Paraesthesia DOSE) ORAL Zyprexa Lilly SS Lilly Date:10/22/99ISR Number: 3377796-3Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Zyprexa (Olanzapine) PS ORAL ORAL 3 MON Initial or Prolonged Medication Error Cogentin C Other Muscle Twitching Tremor Date:10/25/99ISR Number: 3379031-9Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Zyprexa 5 Mg PS ORAL 5MG 1 AM Intervention to 2PMM PO Prevent Permanent Impairment/Damage Date:10/25/99ISR Number: 3380697-8Report Type:Expedited (15-DaCompany Report #GBS990904138 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Increased Health Paroxetine C Initial or Prolonged Blood Glucose Increased Professional Clonazepam C Blood Urea Increased Company Alprazolam C Cardiac Arrest Representative Lithium Carbonate C Coma Other Hepatic Steatosis Hepatomegaly Ketoacidosis Malaise Polydipsia Weight Increased 24-Jun-2005 12:19 PM Page: 781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/99ISR Number: 3380699-1Report Type:Expedited (15-DaCompany Report #EWC990603505 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Olanzapine PS 15 MG/DAY Initial or Prolonged Ascites Health Temesta (Lorazepam) C Blood Bilirubin Increased Professional Dominal Hepatotoxicity Other (Prothipendyl Jaundice Hydrochloride) C Liver Function Test Clotiapine C Abnormal Date:10/25/99ISR Number: 3380731-5Report Type:Expedited (15-DaCompany Report #EWC990804068 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Hospitalization - Bleeding Time Prolonged Health Initial or Prolonged Blood Creatine Professional Disability Phosphokinase Increased Other Catatonia Coma Condition Aggravated Dehydration Disseminated Intravascular Coagulation Hyperpyrexia Leukocytosis Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Opisthotonus Quadriplegia Rhabdomyolysis Date:10/25/99ISR Number: 3380733-9Report Type:Expedited (15-DaCompany Report #US_990928378 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Consumer Zyprexa (Olanzapine) PS 20 MG/1 DAY Breast Neoplasm Valium (Diazepam) C Condition Aggravated Vistaril Hyperprolactinaemia (Hydroxyzine Hydrochloride) C Date:10/25/99ISR Number: 3380735-2Report Type:Expedited (15-DaCompany Report #GBS991004432 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Prolonged Health Zolpidem C Overdose Professional Trimipramine C Ventricular Hypertrophy Other 24-Jun-2005 12:19 PM Page: 782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/99ISR Number: 3381756-6Report Type:Expedited (15-DaCompany Report #217730 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Valium Tablets Initial or Prolonged Liver Function Test Other (Diazepam) PS ORAL 15 MG DAILY Abnormal ORAL Tercian (Cyamemazine) SS ORAL 50 MG DAILY ORAL Deroxat (Paroxetine) SS ORAL 1 DOSE FORM DAILY ORAL Zyprexa (Olanzapine) SS ORAL 2 DOSE FORM DAILY ORAL Date:10/25/99ISR Number: 3382373-4Report Type:Expedited (15-DaCompany Report #EWC991004488 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Hyponatraemia Health Valium (Diazepam) C Inappropriate Professional Antidiuretic Hormone Secretion Pneumonitis Vomiting Date:10/25/99ISR Number: 3382526-5Report Type:Expedited (15-DaCompany Report #EWC991004474 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Increased Health Prozac (Fluoxetine Inflammation Professional Hydrochloride) C Leukocytosis Other Lung Infiltration Microcytic Anaemia Neutropenia Date:10/25/99ISR Number: 3382536-8Report Type:Expedited (15-DaCompany Report #EWC991004497 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Health Professional Company Representative Other Date:10/25/99ISR Number: 3382539-3Report Type:Expedited (15-DaCompany Report #EWC991004496 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Death Death Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG Date:10/25/99ISR Number: 3382544-7Report Type:Expedited (15-DaCompany Report #EWC990904348 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Tachyphylaxis Health Professional Company Representative Other Date:10/25/99ISR Number: 3382549-6Report Type:Expedited (15-DaCompany Report #EWC991004499 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Xanax(Alprazolam) C Professional Company Representative Other Date:10/25/99ISR Number: 3382551-4Report Type:Expedited (15-DaCompany Report #US_991029811 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa(Olanzapine) PS Toxicologic Test Abnormal Professional Mirtazapine C Date:10/25/99ISR Number: 3382557-5Report Type:Expedited (15-DaCompany Report #US_991029594 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa(Olanzapine) PS Hospitalization - Hepatic Failure Professional Wellbutrin(Amfebutam Initial or Prolonged Hyperpyrexia one Hydrochloride) C Renal Failure Buspar(Buspirone Hydrochloride) C Paxil(Paroxetine Hydrochloride) C Date:10/25/99ISR Number: 3382934-2Report Type:Expedited (15-DaCompany Report #217725 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Neotigason Initial or Prolonged Pancreatic Enzyme Health (Acitretin) PS ORAL 25 MG DAILY Abnormality Professional ORAL 183 DAY Pancreatitis Zyprexa (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/99ISR Number: 3395685-5Report Type:Periodic Company Report #99USA11058 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Diovan Capsule Other (Valsartan) PS ORAL 80MG DAILY ORAL Vicodin Tablet 5/500mg (Vicodin) SS ORAL 15MG DAILY ORAL Zyprexa Tablet (Olanzapine) SS ORAL 5MG DAILY ORAL Lipitor Tablet (Atorvastatin) SS ORAL 10MG DAILY ORAL Meridia Capsule (Sibutramine) SS ORAL 15MG DAILY ORAL Detrol Tablets (Tolterodine Tartrate) SS ORAL 4MG DAILY ORAL Celexa Unknown (Citalopram Hydrobromide) SS ORAL 40MG DAILY ORAL Date:10/26/99ISR Number: 3381302-7Report Type:Direct Company Report # Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Lithium 300mg PS ORAL 300 MG PO 1 DAY Initial or Prolonged Depressed Level Of Professional Klopopin 0.5mg SS ORAL 0.5MG PO 1 DAY Consciousness Olanzepine 5mg SS ORAL 5 MG PO 1 DAY Lethargy Mvi SS ORAL TAB 1 DAY Medication Error Speech Disorder Date:10/26/99ISR Number: 3381352-0Report Type:Direct Company Report # Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Zyprexa 10mg Lilly PS Lilly ORAL VARIOU HS Initial or Prolonged Confusional State ORAL Extrapyramidal Disorder Muscle Rigidity Parkinsonism Tremor Date:10/27/99ISR Number: 3381810-9Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Zyprexia 5mg (Lilly) PS Lilly ORAL 5MG PO #30 Initial or Prolonged Agitation ONCE Dysarthria Mental Impairment 24-Jun-2005 12:19 PM Page: 785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/99ISR Number: 3383788-0Report Type:Expedited (15-DaCompany Report #19991000517 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Prilosec Cap PS ORAL 20 MG QD PO Disability Ejection Fraction Health Anafranil - Slow Abnormal Professional Release SS 75 MG BID Hypokinesia Zyprexa SS Left Ventricular Failure Allopurinol C Pericardial Effusion Pneumonia Pulmonary Congestion Pulmonary Hypertension Pyrexia Date:10/27/99ISR Number: 3383825-3Report Type:Expedited (15-DaCompany Report #203688 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Rivatril Anaemia Other (Clonazepam) .5 Mg PS ORAL ORAL Biopsy Bone Marrow Trileptal Abnormal (Oxcarbazepine) 300 Bone Marrow Depression Mg SS ORAL 1050 MG DAILY Cough ORAL Decreased Appetite Zyprexa (Olanzapine) SS 5 MG 1 PER Dizziness DAY Epilepsy Seronil (Fluoxetine Gastrointestinal Disorder Hydrochloride) SS 20 MG 1 PER Hip Fracture DAY Hyponatraemia Spesicor (Metoprolol Leukopenia Tartrate) C Meningioma Primaspan (Aspirin) C Neutropenia Thyroxin Pain In Extremity (Levothyroxine Pyrexia Sodium) C Subdural Haematoma Zocor (Simvastatin) C Urinary Incontinence Nitrosid (Isosorbide Viral Infection Dinitrate) C Actrapid Insulin (Insulin) C Protaphan (Human Insulin Isophane Suspension) C Hydantin (Phenytoin) C Antepsin (Sucralfate) C Deprakine (Valproic Acid) C Absenor (Valproate Sodium) C Panacod (Acetaminophen/Codei ne Phosphate) C 24-Jun-2005 12:19 PM Page: 786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/99ISR Number: 3392344-XReport Type:Periodic Company Report #8-99092-011A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Ativan Tablets PS ORAL 0.5 MG TWICE Professional DAILY ORAL Paxil (Paroxetine) Tablets SS ORAL 30 MG DAILY ORAL Zyprexia (Olanzapine) Tablets SS ORAL 10 MG DAILY ORAL Cogentin (Benztropine) C Venlafaxine Hydrochloride Tablets C Cytomel (Liothyronine) C Zyprexia (Olanzapine) Tablets C Paxil (Paroxetine) Tablets C Synthroid (Levothyroxine) Tablets C Date:11/01/99ISR Number: 3386353-4Report Type:Direct Company Report #CTU 112156 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Health Olanzapine PS Professional Date:11/01/99ISR Number: 3386411-4Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Wellbutrin 150 Sr PS ORAL 150 PO QD -> Extrapyramidal Disorder Professional BID 30 DAY Muscle Twitching Zyprexa 10mg SS 10MG 30 DAY Neuroleptic Malignant Clonazepam C Syndrome Prolixin C Cogentin C Celexa C Date:11/01/99ISR Number: 3386791-XReport Type:Expedited (15-DaCompany Report #99D--10948 Age:65 YR Gender:Female I/FU:I Outcome PT Life-Threatening Bacterial Infection Hospitalization - Drug Level Above Initial or Prolonged Therapeutic Hypokinesia Korsakoff'S Psychosis Non-Alcoholic Left Ventricular Failure Metabolic Disorder Myopathy Toxic 24-Jun-2005 12:19 PM Page: 787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Pulmonary Congestion Pulmonary Hypertension Report Source Product Role Manufacturer Route Dose Duration Viral Infection Foreign Anafranil Retard Health Slow Release Tablet Professional (Clomipramine Other Hydrochloride) PS ORAL UNKN, DAILY,ORAL 18 DAY Zyprexa Unknown (Olanzapine) SS ORAL 10 MG , DAILY, ORAL 23 DAY Allopurinol Unkonwn C Antra Unknown C ... C Date:11/01/99ISR Number: 3386834-3Report Type:Expedited (15-DaCompany Report #10150456 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Lopirin Tabs Initial or Prolonged Drug Interaction (Captopril) PS 18.75 DAY Deroxat (Paroxetine Hcl) SS ORAL 40 MG 1/1 DAY ORAL Zyprexa (Olanzapine) SS ORAL 5 MG 1/1 DAY ORAL Antra (Omeprazole) SS ORAL 20 MG 1/1 DAY ORAL Brufen (Ibuprofen) C Folvite (Folic Acid) C Marcumr (Phenprocoumon) C Date:11/01/99ISR Number: 3386835-5Report Type:Expedited (15-DaCompany Report #10146165 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Foreign Nefazodone Hcl PS ORAL 600 MG 1/1 Initial or Prolonged Paraesthesia Oral Health DAY ORAL Speech Disorder Professional Olanzapine SS 2.5 MG 1/1 DAY Magnesium (Magnesium) C Lorazepam (Lorazepam) C Date:11/01/99ISR Number: 3387967-8Report Type:Periodic Company Report #US_990421336 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Health DAY Professional Tenormin (Atenolol) C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3387968-XReport Type:Periodic Company Report #US_990421366 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 4 DSG FORM/1 Initial or Prolonged Hostility Health AT BED TIME Paranoia Professional Placebo SS 1 DSG FORM/2 Personality Disorder DAY Schizophreniform Disorder Valproic Acid C Docusate Sodium C Lansoprazole C Lorazepam C Therapeutic Multvitamins C Chlorpromazine Hydrochloride C Sunscreen C Fluphenazine C Maalox C Date:11/01/99ISR Number: 3387972-1Report Type:Periodic Company Report #US_990521654 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Study Olanzapine PS 5MG /1 AT Hospitalization - Cardiac Failure Health BEDTIME Initial or Prolonged Congestive Professional Oxazepam C Hostility Lorazepam C Injury Atenolol C Donepezil C Sertraline C Digoxin C Gabapentin C Dulcolax (Bisacodyl) C Date:11/01/99ISR Number: 3387973-3Report Type:Periodic Company Report #US_990521897 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Health DAY Other Professional Placebo SS 2 DSG FORM/1 DAY Nicotine Dermal Patch (Nicotine Resin) C Chloral Hydrate C Date:11/01/99ISR Number: 3387975-7Report Type:Periodic Company Report #US_990522020 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5MG /1 DAY Initial or Prolonged Injury Health Professional 24-Jun-2005 12:19 PM Page: 789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3387976-9Report Type:Periodic Company Report #US_990522240 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parathyroid Disorder Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Schizophreniform Disorder Health AT BED TIME Professional Placebo SS 2 DSG FORM/IN THE MORNING Ativan (Lorazepam) C Inderal (Propranolol Hydrochloride) C Pepcid(Famotidine) C Ranitidine C Trazodone C Date:11/01/99ISR Number: 3387977-0Report Type:Periodic Company Report #US_990522399 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS Initial or Prolonged Health Professional Date:11/01/99ISR Number: 3387979-4Report Type:Periodic Company Report #US_990522518 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 15MG/DAY Initial or Prolonged Health Nortripyline C Professional Date:11/01/99ISR Number: 3387980-0Report Type:Periodic Company Report #US_990522776 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 15 MG/DAY Initial or Prolonged Health Zantac(Ranitidine Disability Professional Hydrochloride) C Cardizem (Diltiazem Hydrochloride) C Synthroid(Levothyrox ine Sodium) C Aspirin C Diclofenac Sodium C Timolol Maleate C Ibuprofen C Xalatan(Latanoprost) C Date:11/01/99ISR Number: 3387981-2Report Type:Periodic Company Report #US_990522926 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Study Zyprexa (Olanzapine) PS 10MG/1 DAY (A Initial or Prolonged Syndrome Health FEW DAYS) Other Professional Clozaril (Clozapine) C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3387983-6Report Type:Periodic Company Report #US_990522937 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Hostility Health AT BEDTIME Schizophreniform Disorder Professional Placebo SS 1 DSG FORM/2DAY Bendryl(Diphenhydram ine Hydrochloride) C Multiple Vitamins C Folic Acid C Thiamine C Amantadine C Benztropine C Haloperidol C Fluphenazine Decanoate C Date:11/01/99ISR Number: 3387985-XReport Type:Periodic Company Report #US_990623057 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Zyprexa (Olanzapine) PS 5MG/1 AT Initial or Prolonged Health BEDTIME Professional Haldol (Haloperidol) C Neutrontin (Gabapentin) C Date:11/01/99ISR Number: 3387986-1Report Type:Periodic Company Report #US_990623153 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 2 DSG FORM Initial or Prolonged Schizophreniform Disorder Health Placebo SS 1 DSG FORM/2 Professional DAY Date:11/01/99ISR Number: 3387987-3Report Type:Periodic Company Report #US_990623404 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Study Zyprexa (Olanzapine Initial or Prolonged Leukocytosis Health ) PS 15MG/1 DAY Professional Depakote (Valproate Semisodium) C Lisinopril C Lithium C Date:11/01/99ISR Number: 3387988-5Report Type:Periodic Company Report #US_990623422 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa (Olanzapine) PS 7.5MG/ 1 AT Initial or Prolonged Pneumonia Health BEDTIME Urinary Tract Infection Professional Ibuprofen C Multivitamins With Iron C Premarin (Estrogens 24-Jun-2005 12:19 PM Page: 791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Conjugated) C Paxil (Paroxetine Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Ferrous Sulfate C Coumadin(Warfarin Sodium) C Pepcid (Famotidine) C Date:11/01/99ISR Number: 3387989-7Report Type:Periodic Company Report #US_990623593 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Study Olanzapine PS 5MG/1DAY Hospitalization - Suicide Attempt Health Fluoxetine(Flouxetin Initial or Prolonged Professional e Hydrochloride) SS 60MG/1DAY Date:11/01/99ISR Number: 3387990-3Report Type:Periodic Company Report #US_990623689 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Study Zyprexa(Olanzapine) PS 1200MG/1DAY Initial or Prolonged Coma Health Convulsion Professional Intentional Misuse Suicide Attempt Date:11/01/99ISR Number: 3387991-5Report Type:Periodic Company Report #US_990623748 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Olanzapine PS 2.5MG/1 DAY Initial or Prolonged Convulsion Health Aricept(Donepezil Professional Hydrochoride) C Multivitamin C Date:11/01/99ISR Number: 3387992-7Report Type:Periodic Company Report #US_990623759 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 2.5MG/1DAY Initial or Prolonged Health Sinemet C Professional Ativan (Lorazepam C Dyazide C Capoten(Captopril) C Elavil (Amitiptyline Hydrochloride) C Ibuprofen C Acetaminophen C Date:11/01/99ISR Number: 3387994-0Report Type:Periodic Company Report #US_990623833 Age:43 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Hallucination 24-Jun-2005 12:19 PM Page: 792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Overdose Sedation Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Study Zyprexa(Olanzapine) PS 10MG/3 DAY Thinking Abnormal Health Prilosec Weight Increased Professional (Omeprazole) C Lithium C Ativan (Lorazepam) C Valium (Diazepam) C Depakote (Valproate Semisodium) C Wellbutrin (Amfebutamone Hydrochloride) C Acetaminophen W/Oxycodone C Klonopin (Clonazepam) C Date:11/01/99ISR Number: 3388332-XReport Type:Periodic Company Report #US_990725506 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Literature Zyprexa (Olanzapine) PS 20 MG/DAY 4 MON Initial or Prolonged Health Risperidone C Professional Date:11/01/99ISR Number: 3388336-7Report Type:Periodic Company Report #US_990928389 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Health Zyprexa (Olanzapine) C Professional Paxil (Paroxetine Hydrochloride) C Date:11/01/99ISR Number: 3388337-9Report Type:Periodic Company Report #US_990725517 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS Initial or Prolonged Health Restoril (Temazepam) C Professional Date:11/01/99ISR Number: 3388347-1Report Type:Periodic Company Report #US_990928639 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Study Olanzapine PS 2.5 MG/ 1 DAY Initial or Prolonged Asthenia Health Aricept (Donepezil Professional Hydrochloride) C Denorex C T-Gel (Coal Tar) C Aspirin C Timoptic (Timolol Maleate) C Multivitamins C 24-Jun-2005 12:19 PM Page: 793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Desoximetasone C Antioxidant C Date:11/01/99ISR Number: 3388348-3Report Type:Periodic Company Report #US_990725551 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa (Olanzapine) PS 30 MG/1 DAY 2 MON Initial or Prolonged Depression Professional Insomnia Company Myalgia Representative Overdose Thinking Abnormal Date:11/01/99ISR Number: 3388352-5Report Type:Periodic Company Report #US_990928660 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 2.5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Relafen (Nabumetone) C Ziac C Macrobid (Nitrofurantoin) C Lorazepam C Date:11/01/99ISR Number: 3388353-7Report Type:Periodic Company Report #US_990928688 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Health Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Aminotransferase Professional Prolixin Decanoate Increased Other (Fluphenazine Hypernatraemia Decanoate) C Hypertonia Catapres-Tts Muscle Twitching (Clonidine) C Pyrexia Date:11/01/99ISR Number: 3388354-9Report Type:Periodic Company Report #US_990725568 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Syndrome Professional Prozac (Fluoxetine Hydrochloride) SS 10 MG/1 DAY Lithium C Ativan (Lorazepam) C Date:11/01/99ISR Number: 3388355-0Report Type:Periodic Company Report #US_990928713 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Study Olanzapine PS 2 DSG FORM/1 Life-Threatening Pneumonia Health AT BEDTIME Hospitalization - Professional Vaseretic C Initial or Prolonged Zocor (Simvastatin) C 24-Jun-2005 12:19 PM Page: 794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multiple Vitamins C Nitrostat (Glyceryl Trinitrate) C Tylenol (Paracetamol) C Coumadin (Warfarin Sodium) C Vioxx (Vioxx) C Erythromycin Ethylsuccinate C Date:11/01/99ISR Number: 3388358-6Report Type:Periodic Company Report #US_990725691 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Olanzapine PS Initial or Prolonged Health Aricept (Donepezil Disability Professional Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Vitamin C C Betacarotene C Vitamin B12 C Ginkobil (Ginkgo Tree Leaves Extract) C Date:11/01/99ISR Number: 3388359-8Report Type:Periodic Company Report #US_990928755 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS Initial or Prolonged Syndrome Professional Other Date:11/01/99ISR Number: 3388360-4Report Type:Periodic Company Report #US_990928796 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 3 MON Professional Luvox (Fluvoxamine Maleate) C Lithium C Xanax (Alprazolam) C Synthroid (Levothyroxine Sodium) C Wellbutrin Sr (Amfebutamone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388361-6Report Type:Periodic Company Report #US_990725706 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Mania Professional Prozac (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Prozac (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Lithium C Klonopin (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Depakote (Valproate Semisodium) C Cytomel (Liothyronine Sodium) C Navane (Tiotixene) C Synthroid (Levothyroxine Sodium) C Trazodone C Ambien (Zolpidem Tartrate) C Tricyclen C Date:11/01/99ISR Number: 3388363-XReport Type:Periodic Company Report #US_990928883 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa (Olanzapine) PS Dry Mouth Dilantin (Phenytoin Sodium) C Phenobarbital C Luvox (Fluvoxamine Maleate) C Date:11/01/99ISR Number: 3388365-3Report Type:Periodic Company Report #US_990928891 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Consumer Zyprexa (Olanzapine) PS Cerebrovascular Accident Convulsion Paraesthesia Sedation Tachycardia Date:11/01/99ISR Number: 3388367-7Report Type:Periodic Company Report #US_990928957 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional 24-Jun-2005 12:19 PM Page: 796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388369-0Report Type:Periodic Company Report #US_990725756 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Study Olanzapine PS 2 DSG Life-Threatening Dementia Health FORM/1DAY Hospitalization - Sedation Professional Prinivil Initial or Prolonged (Lisinopril) C Atenolol C Lanoxin (Digoxin) C Coumadin (Warfarin Sodium) C Floropryl (Isoflurophate) C Premarin (Estrogens Conjugated) C Vitamin E C Multivitamin C Calcium C Date:11/01/99ISR Number: 3388370-7Report Type:Periodic Company Report #US_990929005 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 5 MG Initial or Prolonged Health Placebo SS 1 MG Professional Multivitamin C Date:11/01/99ISR Number: 3388374-4Report Type:Periodic Company Report #US_990929042 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Depakote (Valproate Semisodium) C Ecotrin (Acetylsalicylic Acid) C Synthroid (Levothyroxine Sodium) C Date:11/01/99ISR Number: 3388375-6Report Type:Periodic Company Report #US_990725832 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Study Olanzapine PS Initial or Prolonged Schizophreniform Disorder Health Placebo SS Professional Bactrim Ds C Clotrimazole C Zantac (Ranitidine Hydrochloride) C Propranolol C Timolol C Acetaminophen W/Codeine C Hydroxyzine C Demerol (Pethidine 24-Jun-2005 12:19 PM Page: 797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/01/99ISR Number: 3388381-1Report Type:Periodic Company Report #US_990725892 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 4 DSG FORM Initial or Prolonged Health Paxil (Paroxetine Professional Hydrochloride) C Depakote (Valproate Semisodium) C Glucophage (Metformin Hydrochloride) C Multivitamin C Motrin (Ibuprofen) C Date:11/01/99ISR Number: 3388392-6Report Type:Periodic Company Report #US_990826026 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS Initial or Prolonged Health Olanzapine SS Professional Lorazepam C Enalapril C Furosemide C Digoxin C Thiamine C Ranitidine C Date:11/01/99ISR Number: 3388408-7Report Type:Periodic Company Report #US_990826032 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY Prozac (Fluoxetine Hydrochloride) C Albuterol C Ipratropium Bromide C Date:11/01/99ISR Number: 3388419-1Report Type:Periodic Company Report #US_981214327 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG Initial or Prolonged Health Placebo SS Professional Date:11/01/99ISR Number: 3388428-2Report Type:Periodic Company Report #US_981214701 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Schizophreniform Disorder Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Olanzapine PS 10 MG/DAILY DAY Placebo SS 2 MG/DAILY DAY Lisinopril C Date:11/01/99ISR Number: 3388432-4Report Type:Periodic Company Report #US_981214970 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Study Olanzapine PS 10 MG/DAILY Initial or Prolonged Hyponatraemia Health DAY Hypothyroidism Professional Placebo SS Pericardial Effusion Pleural Effusion Date:11/01/99ISR Number: 3388436-1Report Type:Periodic Company Report #US_981215194 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Alcohol Intolerance Health Placebo SS 2 MG Drug Dependence Professional Atenolol C Diphenhydramine C Gentamicin C Multivitamin C Timolol Maleate C Olanzapine C Date:11/01/99ISR Number: 3388439-7Report Type:Periodic Company Report #US_981215243 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Hallucination Health AT BEDTIME Professional Placebo SS 1 DSG FORM/ 2 DAY Didanosine C Lamivudine C Zidovudine C Trazodone C Combivir C Nelfinavir C Cimetidine C Multivitamins C Zoloft (Sertraline Hydrochloride) C Haldol (Haloperidol) C Vitamin E C 24-Jun-2005 12:19 PM Page: 799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388443-9Report Type:Periodic Company Report #US_990826039 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 17.5 MG DAY Initial or Prolonged Hallucination Health Lorazepam C Professional Date:11/01/99ISR Number: 3388450-6Report Type:Periodic Company Report #US_990115861 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Olanzapine PS 2 DSG Initial or Prolonged Hyponatraemia Health FORM/1/D DAY Water Intoxication Professional Placebo SS 2 DSG FORM/1/D DAY Propranolol C Multivitamin C Vitamin E C Aspirin Enteric Coated K.P. (Acetylsalicylic Acid) C Date:11/01/99ISR Number: 3388456-7Report Type:Periodic Company Report #US_990116197 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Study Olanzapine PS 5 MG / 1 Initial or Prolonged Health EVERY OTHER Professional DAY Mevacor (Lovastatin) C Aricept (Donepezil Hydrochloride) C Cardizem (Diltiazem Hydrochloride) C Nitroglycerin Transdermal System (Glyceryltrinitrate) C Aspirin Enteric Coated K.P. (Acetylsalicylic Acid) C Mylanta C Paxil (Paroxetine Hydrochloride) C Gingkomin (Ginggo Biloba) C Date:11/01/99ISR Number: 3388462-2Report Type:Periodic Company Report #US_990217371 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/ 1 IN Initial or Prolonged Dizziness Health THE EVENING Injury Professional Fluoxetine Paraesthesia (Fluoxetine Thinking Abnormal Hydrochloride) SS 60 MG/1 IN THE MORNING 24-Jun-2005 12:19 PM Page: 800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Ativan (Lorazepam) C Date:11/01/99ISR Number: 3388467-1Report Type:Periodic Company Report #US_990217403 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Hostility Health AT BEDTIME Thinking Abnormal Professional Placebo SS 1 DSG FORM/2 DAY Metformin C Insulin Injection, Isophane C Insulin Human Zinc Suspension C Simvastatin C Tretinoin C Ibuprofen C Date:11/01/99ISR Number: 3388469-5Report Type:Periodic Company Report #US_990217553 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 1 DSG FORM/1 Hospitalization - Urinary Tract Infection Health IN THE Initial or Prolonged Professional MORNING Placebo SS 2 DSG FORM/1 AT BED TIME Naprosyn (Naproxen) C Ultram (Tramadol Hydrochloride) C Multivitamin C Fibercon (Polycarbophil Calcium) C Zoloft (Sertraline Hydrohloride) C Ritalin (Methylphenidate Hydrochloride) C Risperdal (Risperidone) C Paroxetine C Date:11/01/99ISR Number: 3388470-1Report Type:Periodic Company Report #US_990218051 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Olanzapine PS 10 MG DAY Initial or Prolonged Depression Health Placebo SS 2 MG DAY Professional Vitamin E C Glyburide C Fosinopril C Thiamine C 24-Jun-2005 12:19 PM Page: 801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388471-3Report Type:Periodic Company Report #US_990826102 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Hypoventilation Professional Personality Disorder Company Stupor Representative Date:11/01/99ISR Number: 3388473-7Report Type:Periodic Company Report #US_990218098 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Zyprexa (Olanzapine) PS 30 MG/ 1 DAY Convulsion Health Benadryl Dermatitis Professional (Diphenhydramine Oedema Peripheral Hydrochloride) C Overdose Dilantin (Phenytoin Urinary Incontinence Sodium) C Weight Increased Tegretol (Carbamazepine) C Ativan (Lorazepam) C Date:11/01/99ISR Number: 3388475-0Report Type:Periodic Company Report #US_990218160 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Study Olanzapine PS 5 MG/2 DAY Initial or Prolonged Injury Health Prozac (Fluoxetine Oesophageal Ulcer Professional Hydrochloride) C Aspirin C Trazodone C Vitamin B12 C Imdur (Isosorbide Mononitrate) C Ferrous Sulfate C Date:11/01/99ISR Number: 3388476-2Report Type:Periodic Company Report #US_990826243 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Zyprexa (Olanzapine) PS 10 MG/1 IN Initial or Prolonged Drug Dependence Health THE MORNING Professional Trazodone C Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Revia (Naltrexone) C Motrin (Ibuprofen) C Date:11/01/99ISR Number: 3388478-6Report Type:Periodic Company Report #US_990218318 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 4 DSG FORM/1 Initial or Prolonged Schizophreniform Disorder Health DAY Professional Placebo SS 2 DSG FORM/1 24-Jun-2005 12:19 PM Page: 802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY Lisinopril C Atenolol C Hydrochlorothiazide C Levothyroxine C Date:11/01/99ISR Number: 3388480-4Report Type:Periodic Company Report #US_990319808 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS 17.5 MG/1 AT Initial or Prolonged Psychotic Disorder Health BEDTIME Schizophreniform Disorder Professional Depakote (Valproate Semisodium) C Benztropine C Sudafed (Pseudoephedrine Hydrochloride) C Inderal (Propranolol Hydrochloride) C Tylenol (Paracetamol) C Date:11/01/99ISR Number: 3388481-6Report Type:Periodic Company Report #US_990319820 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Psychotic Disorder Health DAY Thinking Abnormal Professional Placebo SS 2 DSG FORM/1 DAY Prolixin Decanoate (Fluphenazine Decanoate) C Diazepam C Zoloft (Sertraline Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Docusate Sodium C Amlodipine C Lansoprazole C Date:11/01/99ISR Number: 3388482-8Report Type:Periodic Company Report #US_990826260 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS Initial or Prolonged Health Placebo SS Professional Propranolol C Lorazepam C Trazodone C Divalproex Sodium C 24-Jun-2005 12:19 PM Page: 803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388484-1Report Type:Periodic Company Report #US_990420145 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY Hydroxyzine C Date:11/01/99ISR Number: 3388485-3Report Type:Periodic Company Report #US_990420579 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Study Olanzapine PS 15 MG/1 AT Initial or Prolonged Pneumonia Health BEDTIME Professional Albuterol C Ibuprofen C Insulin Human C Ipratropium C Multivitamin C Triamcinolone C Levofloxacin C Date:11/01/99ISR Number: 3388487-7Report Type:Periodic Company Report #US_990826288 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS Initial or Prolonged Health Placebo SS Professional Disulfiram C Docusate C Imipramine C Clonazepam C Trazodone C Valproic Acid C Naproxen C Date:11/01/99ISR Number: 3388489-0Report Type:Periodic Company Report #US_990826298 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Olanzapine PS 20 MG Hospitalization - Health Initial or Prolonged Professional Date:11/01/99ISR Number: 3388491-9Report Type:Periodic Company Report #US_990826336 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 2.5 MG AT Initial or Prolonged Chest Pain Health BEDTIME Professional Lorazepam C Effexor (Venlafaxine Hydrochloride) C Aspirin C Aricept (Donepezil Hydrochloride) C 24-Jun-2005 12:19 PM Page: 804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamin C Date:11/01/99ISR Number: 3388493-2Report Type:Periodic Company Report #US_990420770 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Study Olanzapine PS 2.5 MG/1 DAY Initial or Prolonged Health Multivitamin C Professional Seborrhea Ointment C Bacitracin C Acetaminophen C Terazosin C Hydrochlorothiazide / Triamterene C Docusate C Aloes C Date:11/01/99ISR Number: 3388495-6Report Type:Periodic Company Report #US_990421258 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Cancer Study Olanzapine PS 5 MG/1 AT Health BEDTIME Professional Multivitamins W/Minerals C Aspirin C Zoloft (Sertraline Hydrochloride) C Date:11/01/99ISR Number: 3388496-8Report Type:Periodic Company Report #US_990826359 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Lithium C Prozac (Fluoxetine Hydrochloride) C Ibuprofen C Date:11/01/99ISR Number: 3388506-8Report Type:Periodic Company Report #US_990826367 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Health Cogentin Professional (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:11/01/99ISR Number: 3388514-7Report Type:Periodic Company Report #US_990927510 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Depression Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Olanzapine PS 10 MG/DAY 1 WK Zoloft (Sertraline Hydrochloride) C Lithbid (Lithium Carbonate) C Date:11/01/99ISR Number: 3388518-4Report Type:Periodic Company Report #US_990927561 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Syndrome Professional Paxil (Paroxetine Company Hydrochloride) C Representative Date:11/01/99ISR Number: 3388525-1Report Type:Periodic Company Report #US_990927684 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Fluoxetine Initial or Prolonged Health (Fluoxetine Professional Hydrochloride) PS 20 MG 1 DAY Olanzapine SS 10 MG 1 DAY Glucophage (Metformin Hydrochloride) C Glucotrol (Glipizide) C Cardizem Cd (Diltiazem Hydrochloride) C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Date:11/01/99ISR Number: 3388532-9Report Type:Periodic Company Report #US_990927748 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Intracranial Study Olanzapine PS 2.5 MG/2 DAY Initial or Prolonged Laboratory Test Abnormal Health Olanzapine SS 2.5 MG 1 DAY Disability Professional Furosemide C K-Dur (Potassium Chloride) C Norvasc (Amlodipine Besilate) C Vitamin C C Vitamin E C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388535-4Report Type:Periodic Company Report #US_990927802 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Olanzapine PS 10 MG 1 AT Initial or Prolonged Study BEDTIME Health Aspirin C Professional Divalproex Sodium C Felodipine C Propranolol C Trazodone C Date:11/01/99ISR Number: 3388538-XReport Type:Periodic Company Report #US_990927886 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Effect Increased Study Olanzapine PS 20 MG 1 IN Hospitalization - Health THE EVENING Initial or Prolonged Professional Depakote (Valproate Semisodium) C Date:11/01/99ISR Number: 3388541-XReport Type:Periodic Company Report #US_990927934 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Olanzapine PS 2.5 MG 1 DAY Initial or Prolonged Health Professional Date:11/01/99ISR Number: 3388543-3Report Type:Periodic Company Report #US_990927943 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 10 MG/ 1 DAY Initial or Prolonged Hallucination Health Paranoia Professional Date:11/01/99ISR Number: 3388544-5Report Type:Periodic Company Report #US_990927953 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 20 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Prozac (Fluoxetine Hydrochloride) C Ativan (Lorazepam) C Date:11/01/99ISR Number: 3388545-7Report Type:Periodic Company Report #US_990927974 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG/ 1 DAY Initial or Prolonged Health Lorazepam C Professional 24-Jun-2005 12:19 PM Page: 807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388549-4Report Type:Periodic Company Report #US_990928068 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Professional Aspirin C Premarin (Estrogens Conjugated) C Date:11/01/99ISR Number: 3388550-0Report Type:Periodic Company Report #US_990928072 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 2 DSG FORM AT Initial or Prolonged Health BEDTIME Professional Zantac (Ranitidine Hydrochloride) C Vasotec (Enalapril Maleate) C Micronase (Glibenclamide) C Nitro Patch (Glyceryl Trinitrate) C Trimethoprim C Date:11/01/99ISR Number: 3388552-4Report Type:Periodic Company Report #US_990928118 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 2 DSG FORM Initial or Prolonged Injury Health Lanoxin (Digoxin) C Professional Aricept (Donepezil Hydrochloride) C Fosamax (Alendronate Sodium) C Date:11/01/99ISR Number: 3388554-8Report Type:Periodic Company Report #US_990928119 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Study Olanzapine PS Initial or Prolonged Health Olanzapine SS 10 MG/ 1 DAY Professional Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3388555-XReport Type:Periodic Company Report #US_990928129 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS 200 MG/ 1 DAY Initial or Prolonged Sedation Professional Neurontin (Gabapentin) C Celexa (Citalopram Hydrochloride) C Date:11/01/99ISR Number: 3388557-3Report Type:Periodic Company Report #US_990928148 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 1 DSG FORM Initial or Prolonged Health Valproic Acid C Professional Ranitidine C Astemizole C Date:11/01/99ISR Number: 3388559-7Report Type:Periodic Company Report #US_990928248 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olazanpine) PS 150 MG Initial or Prolonged Pyrexia Professional Company Representative Date:11/01/99ISR Number: 3388561-5Report Type:Periodic Company Report #US_990928342 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Study Olanzapine PS 5 MG Initial or Prolonged Health Divalproex Sodium C Professional Trazodone C Donepezil C Vitamin E C Ginkoba (Ginkgo Tree Leaves Extract) C Date:11/01/99ISR Number: 3388565-2Report Type:Periodic Company Report #US_990928350 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG Initial or Prolonged Psychotic Disorder Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 80 MG Date:11/01/99ISR Number: 3388567-6Report Type:Periodic Company Report #US_990928355 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG Initial or Prolonged Health Aspirin C Professional Propranolol C Ambien (Zolpidem 24-Jun-2005 12:19 PM Page: 809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) C Glucophage (Metformin Hydrochloride) C Date:11/01/99ISR Number: 3392264-0Report Type:Periodic Company Report #US_990623999 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10MG 1 DAY Initial or Prolonged Hostility Health Prozac (Fluoxetine Professional Hydrochloride) C Ferrous Sulfate C Date:11/01/99ISR Number: 3392265-2Report Type:Periodic Company Report #US_990624060 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10MG 1 AT Initial or Prolonged Schizophreniform Disorder Health BEDTIME Professional Placebo SS 60MG 1 DAY Date:11/01/99ISR Number: 3392266-4Report Type:Periodic Company Report #US_990624088 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 1 DSG FORM / Initial or Prolonged Health 1 AT BEDTIME Professional Hydrochlorothiazide C Vitamin E C Ginkgo Biloba C Centrum Silver C The Brain 111 Energizer C The Brain 111 Am C Lecithin C Miacalcin (Calcitonin, Salmon) C Oscal (Calsium Carbonate) C Azithromycin C Digoxin C Aspirin Protect (Acetylsalicylic Acid) C Diltiazem C Date:11/01/99ISR Number: 3392267-6Report Type:Periodic Company Report #US_990624194 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Health Zyprexa (Olanzapine) PS 10MG DAY Professional Mellaril Company (Thioridazine Representative Hydrochloride) C 24-Jun-2005 12:19 PM Page: 810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392270-6Report Type:Periodic Company Report #US_990624398 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Consumer Zyprexa (Olanzapine) PS 10MG 2 DAY Initial or Prolonged Mania Lithium C Navane (Tiotixene) C Date:11/01/99ISR Number: 3392271-8Report Type:Periodic Company Report #US_990624421 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 10MG / 1 AT Initial or Prolonged Health BETIME Professional Restoril (Temazepam) C Nefedipine - Slow Release (Nifedipine) C Donepezil C Metamucil (Psyllium Hydrophilic Mucilloid) C Hemorrhoidal Ointment C Trazodone` C Date:11/01/99ISR Number: 3392273-1Report Type:Periodic Company Report #US_990724531 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Study Olanzapine PS 2 DSG FORM 1 Initial or Prolonged Health AT BEDTIME Professional Aricept (Donepezil Hydrochloride) C Glyburide C Date:11/01/99ISR Number: 3392275-5Report Type:Periodic Company Report #US_990724781 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15MG DAY Initial or Prolonged Schizophreniform Disorder Health Effexor (Venlafaxine Professional Hydrochloride) C Depo Provera (Medroxyprogesterone Acetate) C Atrovent (Ipratropium Bromide) C Seroquel C Date:11/01/99ISR Number: 3392296-2Report Type:Periodic Company Report #US_990724914 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392298-6Report Type:Periodic Company Report #US_990724989 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Study Olanzapine PS 20MG Health Lorazepam C Professional Synthroid (Levothyroxine Sodium) C Hypothyroidism C Date:11/01/99ISR Number: 3392314-1Report Type:Periodic Company Report #US_990725003 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Literature Olanzapine PS 5MG DAY Neuroleptic Malignant Health Syndrome Professional Date:11/01/99ISR Number: 3392316-5Report Type:Periodic Company Report #US_990725051 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Olanzapine PS 3 DSG FORM 2 Health DAY Professional Serax (Oxazepam) C Date:11/01/99ISR Number: 3392318-9Report Type:Periodic Company Report #US_990725089 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 30MG 1 DAY Initial or Prolonged Depression Professional Synthroid Hallucination Company (Levothyroxine Hostility Representative Sodium) C Overdose Pepcid (Famotidine) C Weight Increased Celexa (Citalopram Hydrobromide) C Wellbutrin Sr (Amfebutamone Hydrochloride) C Date:11/01/99ISR Number: 3392319-0Report Type:Periodic Company Report #US_990725159 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 15MG 2 DAY Influenza Like Illness Professional Depakote (Valproate Leukopenia Company Semisodium) C Overdose Representative Neurontin Sedation (Gabapentin) C Thrombocytopenia Diamox (Acetazolamide) C Temazepam C 24-Jun-2005 12:19 PM Page: 812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392321-9Report Type:Periodic Company Report #US_990725226 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 10MG 1 AT Initial or Prolonged Professional BEDTIME Other Synthroid (Levothyroxine Sodium) C Date:11/01/99ISR Number: 3392325-6Report Type:Periodic Company Report #US_990725231 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa (Olanzapine) PS 2.5MG 1 DAY Initial or Prolonged Consciousness Professional Soma (Carisoprodol) C Stupor Date:11/01/99ISR Number: 3392330-XReport Type:Periodic Company Report #US_990725290 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accident Study Olanzapine PS 5MG 1 AT Hospitalization - Acute Abdomen Health BEDTIME Initial or Prolonged Professional Prozac (Fluoxetine Other Hydrochloride) C Eskalith (Lithium Carbonate) C Pseudoephedrine C Chlorpheniramine C Ibuprofen C Date:11/01/99ISR Number: 3392333-5Report Type:Periodic Company Report #US_990725352 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Consumer Zyprexa (Olanzapine) PS 5MG 1 DAY 1 WK Initial or Prolonged Deficit/Hyperactivity Health Catapres (Clonidine) C Other Disorder Professional Hostility Insomnia Date:11/01/99ISR Number: 3392335-9Report Type:Periodic Company Report #US_990725399 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa (Olanzapine) PS 15MG Q AT Initial or Prolonged Increased Professional BEDTIME Diabetic Ketoacidosis Other Propranolol C Tachycardia Zoloft (Sertraline Weight Increased Hydrochloride) C Buspar (Buspirone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392337-2Report Type:Periodic Company Report #US_990725464 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20MG DAY Initial or Prolonged Health Professional Date:11/01/99ISR Number: 3392338-4Report Type:Periodic Company Report #US97033745A Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulse Absent Study Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Hospitalization - Respiratory Arrest Health Tylenol C Initial or Prolonged Professional Ibuprofen C Aspirin C Zestril C Niferex C Bumex C Milk Of Magnesia C Vistaril C Date:11/01/99ISR Number: 3392340-2Report Type:Periodic Company Report #US97101204A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Literature Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 1 YR Initial or Prolonged Diabetes Mellitus Health Lamictal C Weight Increased Professional Lithium C Paroxetine C Date:11/01/99ISR Number: 3392343-8Report Type:Periodic Company Report #US97102155A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Literature Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 8 MON Initial or Prolonged Diabetes Mellitus Health Depakote C Diabetic Ketoacidosis Professional Fungal Infection Weight Increased Date:11/01/99ISR Number: 3392345-1Report Type:Periodic Company Report #US97102230A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Zyprexa (Olanzapine) PS 20 MG/ 1 DAY 6 MON Initial or Prolonged Drug Ineffective Health Tegretol C Weight Increased Professional Clonazepam C Date:11/01/99ISR Number: 3392348-7Report Type:Periodic Company Report #US_980402270 Age:88 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Gastrointestinal Haemorrhage Haematemesis 24-Jun-2005 12:19 PM Page: 814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Peptic Ulcer Vomiting Report Source Product Role Manufacturer Route Dose Duration Study Zyprexa (Olanzapine) PS 5 MG/1 DAY Health Ultram C Professional Desyrel C Paxil C Buspar C Tylenol C Lasix C Coumadin C Ismo C Miacalcin C Theragran C Thiamine C Tums C Micro K Extencaps C Date:11/01/99ISR Number: 3392350-5Report Type:Periodic Company Report #US_980503181 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Zyprexa (Olanzapine) PS 5 MG/1 DAY Coma Health Haloperidol C Constipation Professional Lithium Carbonate C Depression Lorazepam C Hallucination Benztropine C Immune System Disorder Senna C Pain Divalproex Sodium C Stomatitis Acetaminophen C Tremor Omeprazole C Date:11/01/99ISR Number: 3392374-8Report Type:Periodic Company Report #US_980503436 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 2.5 MG/QHS Initial or Prolonged Hypoglycaemia Health DAY Hypotension Professional Allopurinol C Sedation Insulin Humulin C Glyburide C Clonidine C Fosinopril C Lasix C Albuterol C Beclomethasone Dipropionate C Motrin C Co-Trimoxazole C Haloperidol C Date:11/01/99ISR Number: 3392391-8Report Type:Periodic Company Report #US_980503937 Age:41 YR Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Dehydration Dysuria 24-Jun-2005 12:19 PM Page: 815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glucose Urine Hyperglycaemia Hyponatraemia Report Source Product Role Manufacturer Route Dose Duration Ketoacidosis Literature Zyprexa (Olanzapine) PS 10 MG/1 DAY Oedema Peripheral Health Thiothixene C Polyuria Professional Valproic Acid C Sedation Paroxetine C Thirst Medroxyprogesterone C Urinary Tract Infection Weight Decreased Date:11/01/99ISR Number: 3392395-5Report Type:Periodic Company Report #US_980504164 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Olanzapine PS 2.5 MG/DAY Hospitalization - Urinary Tract Infection Health Sinemet Cr C Initial or Prolonged Professional Sinemet C Glyburide C Tylenol C Lotrisone C Dyazide C Date:11/01/99ISR Number: 3392399-2Report Type:Periodic Company Report #US_980604821 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Study Olanzapine PS 5 MG/D DAY Initial or Prolonged Health Aspirin C Disability Professional Lanoxin C Date:11/01/99ISR Number: 3392403-1Report Type:Periodic Company Report #US_980606080 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 4 DSG FORM/1 Initial or Prolonged Anxiety Health AT BEDTIME Other Depression Professional Placebo SS Hallucination Lorazepam C Hostility Levothyroxine C Mania Carbamazepine C Paranoia Effexor C Docusate Sodium C Date:11/01/99ISR Number: 3392419-5Report Type:Periodic Company Report #US_980706442 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 5 MG/DAY Initial or Prolonged Hostility Health Prevacid C Professional 24-Jun-2005 12:19 PM Page: 816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392422-5Report Type:Periodic Company Report #US_980807835 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Literature Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Intentional Misuse Health Depakene C Orthostatic Hypotension Professional Prolixin C Sedation Nifedipine C Speech Disorder Benztropine Mesylate C Tachycardia Tongue Oedema Weight Decreased Weight Increased Date:11/01/99ISR Number: 3392426-2Report Type:Periodic Company Report #US_980808323 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/D DAY 5 DAY Initial or Prolonged Health Placebo SS 2 MG/D DAY Professional Ativan C Date:11/01/99ISR Number: 3392433-XReport Type:Periodic Company Report #US_980808583 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS Initial or Prolonged Depression Health Placebo SS Hallucination Professional Norvasc C Major Depression Date:11/01/99ISR Number: 3392435-3Report Type:Periodic Company Report #US_980809192 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/D DAY Initial or Prolonged Health Placebo SS 2 MG/D DAY Professional Ibuprofen C Date:11/01/99ISR Number: 3392438-9Report Type:Periodic Company Report #US_981011786 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Olanzapine PS 10 MG/D DAY Health Lasix C Professional Zyprexa C Aleve C Date:11/01/99ISR Number: 3392442-0Report Type:Periodic Company Report #US_981012436 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Study Olanzapine PS 15 MG/D DAY Health Placebo SS 1 DSG FORM/1 Professional DAY Amaryl C 24-Jun-2005 12:19 PM Page: 817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392468-7Report Type:Periodic Company Report #US_981113065 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 20 MG/HS AT Initial or Prolonged Health BEDTIME Professional Placebo SS Lorazepam C Divalproex C Benztropine C Fluphenazine C Fluphenazine Decanoate C Date:11/01/99ISR Number: 3392475-4Report Type:Periodic Company Report #US_981113076 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG/D DAY Initial or Prolonged Hallucination Health Placebo SS Professional Zestril C Prolixin C Cogentin C Date:11/01/99ISR Number: 3392900-9Report Type:Periodic Company Report #US_990826382 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG DAY Initial or Prolonged Schizophreniform Disorder Health Klonopin Professional (Clonazepam) C Diazepam C Paxil (Paroxetine Hydrochloride) C Asa (Acetylsalicylic Acid) C Ativan (Lorazepam) C Celexa (Citalopram Hydrobromide) C Nitro (Glyceryl Trinitrate) C Zyprexa (Olanzapine) C Date:11/01/99ISR Number: 3392904-6Report Type:Periodic Company Report #US_990826505 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 10 MG/1 DAY Initial or Prolonged Health Synthroid Professional (Levothyroxine Sodium) C Atorvastatin C 24-Jun-2005 12:19 PM Page: 818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392909-5Report Type:Periodic Company Report #US_990826526 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa (Olanzapine) PS 15 MG/1 AT Initial or Prolonged Psychotic Disorder Health BEDTIME Professional Zoloft (Sertraline Hydrochloride) C Klonopin (Clonazepam) C Date:11/01/99ISR Number: 3392912-5Report Type:Periodic Company Report #US_990826612 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Study Olanzapine PS 15 MG/1 DAY Life-Threatening Cardiac Arrest Health Cogentin Professional (Benzatropine Mesilate) C Paxil (Paroxetine Hydrochloride) C Temazepam C Date:11/01/99ISR Number: 3392914-9Report Type:Periodic Company Report #US_990826636 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Health Tylenol Professional (Paracetamol) C Date:11/01/99ISR Number: 3392918-6Report Type:Periodic Company Report #US_990826683 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS Initial or Prolonged Health Depakote (Valproate Professional Semisodium) C Date:11/01/99ISR Number: 3392922-8Report Type:Periodic Company Report #US_990826822 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Depakote (Valproate Semisodium) C Ambien (Zolpidem Tartrate) C Date:11/01/99ISR Number: 3392924-1Report Type:Periodic Company Report #US_990827076 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Hyponatraemia Professional 24-Jun-2005 12:19 PM Page: 819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392926-5Report Type:Periodic Company Report #US_990827086 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Zyprexa (Olanzapine) PS 800 NG DAY Initial or Prolonged Anticholinergic Syndrome Health Arthralgia Professional Depressed Level Of Consciousness Dystonia Electrocardiogram Abnormal Intentional Misuse Myalgia Pyrexia Speech Disorder Date:11/01/99ISR Number: 3392929-0Report Type:Periodic Company Report #US_990827137 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Olanzapine PS 10 MG/1 DAY Initial or Prolonged Health Professional Date:11/01/99ISR Number: 3392931-9Report Type:Periodic Company Report #US_990827145 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 15 MG/1 DAY Initial or Prolonged Psychotic Disorder Health Placebo SS 2 MG/1 DAY Professional Clonazepam C Nicotine Dermal Patch C Date:11/01/99ISR Number: 3392933-2Report Type:Periodic Company Report #US_990827159 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Syndrome Professional Depakote (Valproate Company Semisodium) C Representative Date:11/01/99ISR Number: 3392934-4Report Type:Periodic Company Report #US_990827174 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Health Zyprexa (Olanzapine) PS 20 MG Hypertonia Professional Lithium C Pyrexia Company Representative 24-Jun-2005 12:19 PM Page: 820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3392935-6Report Type:Periodic Company Report #US_990827181 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Syndrome Professional Mellaril Company (Thioridazine Representative Hydrochloride) C Haldol (Haloperidol) C Symmetrel (Amantadine Hydrochloride) C Date:11/01/99ISR Number: 3392936-8Report Type:Periodic Company Report #US_990827255 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Professional Depakote (Valproate Company Semisodium) C Representative Date:11/01/99ISR Number: 3392939-3Report Type:Periodic Company Report #US_990827336 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Study Olanzapine PS 10 MG Other Abnormal Health Ativan (Lorazepam) C Professional Date:11/01/99ISR Number: 3392944-7Report Type:Periodic Company Report #US_990827383 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG Initial or Prolonged Liver Function Test Health Pepto-Bismol Abnormal Professional (Bismuth Subsalicylate) C Tylenol (Paracetamol) C Date:11/01/99ISR Number: 3392946-0Report Type:Periodic Company Report #US_990827384 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Effexor (Venlafaxine Company Hydrochloride) C Representative Date:11/01/99ISR Number: 3392948-4Report Type:Periodic Company Report #US_990827387 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Other Convulsion Health Professional Company 24-Jun-2005 12:19 PM Page: 821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG/2 DAY Lithium C Zoloft (Sertraline Hydrochloride) C Date:11/01/99ISR Number: 3392951-4Report Type:Periodic Company Report #US_990927450 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 4 DSG FORM Initial or Prolonged Health Depakote (Valproate Professional Semisodium) C Date:11/01/99ISR Number: 3396718-2Report Type:Periodic Company Report #US_990929055 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 5 MG/DAY 9 MON Professional Ritalin (Methylphenidate Hydrochloride) C Luvox (Fluvoxamine Maleate) C Date:11/01/99ISR Number: 3396719-4Report Type:Periodic Company Report #US_990929095 Age:8 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Growth Retardation Health Zyprexa (Olanzapine) PS Weight Increased Professional Zoloft (Sertraline Hydrochloride) C Date:11/01/99ISR Number: 3396720-0Report Type:Periodic Company Report #US_990928912 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vitreous Disorder Consumer Zyprexa (Olanzapine) PS 2.5 MG/DAY Celexa (Citalopram Hydrobromide) C Klonopin (Clonazepam) C Estratest Hs C Date:11/01/99ISR Number: 3396721-2Report Type:Periodic Company Report #US_990928938 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 60 MG/DAY Professional 24-Jun-2005 12:19 PM Page: 822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3396722-4Report Type:Periodic Company Report #US_990928431 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 30 MG/DAY Professional Date:11/01/99ISR Number: 3396723-6Report Type:Periodic Company Report #US_990928436 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Prevacid (Lansoprazole) C Depakote (Valproate Semisodium) C Multivitamin C Date:11/01/99ISR Number: 3396724-8Report Type:Periodic Company Report #US_990927961 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 35 MG/AT Professional BEDTIME 7 MON Date:11/01/99ISR Number: 3396725-XReport Type:Periodic Company Report #US_990927822 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/01/99ISR Number: 3396726-1Report Type:Periodic Company Report #US_990827347 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Health Zyprexa (Olanzapine) PS Professional Depakote (Valproate Semisodium) C Date:11/01/99ISR Number: 3396727-3Report Type:Periodic Company Report #US_990827310 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 30 MG/DAY Professional Date:11/01/99ISR Number: 3396728-5Report Type:Periodic Company Report #US_990827313 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 50 MG/DAY Professional Lamotrigine C 24-Jun-2005 12:19 PM Page: 823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3396729-7Report Type:Periodic Company Report #US_990826907 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gout Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Date:11/01/99ISR Number: 3396730-3Report Type:Periodic Company Report #US_990826693 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Gabapentin C Effexor (Venlafaxine Hydrochloride) C Cyclobenzapine C Lipitor (Atorvastatin) C Topamax (Topiramate) C Prevacid (Lansoprazole) C Tylenol (Paracetamol) C Magnesium Hydroxide C Kaopectate C Aluminium Hydroxide C Date:11/01/99ISR Number: 3396731-5Report Type:Periodic Company Report #US_990826802 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Humulin-Human Nph Insulin (Rdna) (Human Insulin (Rdna Origin)) SS Lisinopril C Aspirin C Glyburide C Terazosin C Date:11/01/99ISR Number: 3396732-7Report Type:Periodic Company Report #US_990826385 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Thromboplastin Health Zyprexa (Olanzapine) PS 2 YR Decreased Professional Hypogammaglobulinaemia Laboratory Test Abnormal Date:11/01/99ISR Number: 3396733-9Report Type:Periodic Company Report #US_990826368 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Thromboplastin Health Zyprexa (Olanzapine) PS 2 YR Decreased Professional Laboratory Test Abnormal 24-Jun-2005 12:19 PM Page: 824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3396734-0Report Type:Periodic Company Report #US_990826379 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Thromboplastin Health Zyprexa (Olanzapine) PS 18 MON Decreased Professional Laboratory Test Abnormal Date:11/01/99ISR Number: 3396735-2Report Type:Periodic Company Report #US_990826176 Age:9 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Disorder Health Zyprexa (Olanzapine) PS 20 MG/DAY 2 YR Professional Neurontin Company (Gabapentin) C Representative Adderall C Date:11/01/99ISR Number: 3396736-4Report Type:Periodic Company Report #US_990826047 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS Professional Date:11/01/99ISR Number: 3396737-6Report Type:Periodic Company Report #US_990825960 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hair Disorder Health Zyprexa (Olanzapine) PS 5 MG/DAY 4 WK Professional Date:11/01/99ISR Number: 3398842-7Report Type:Periodic Company Report #US_990725798 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa (Olanzapine) PS 20 MG / DAY Professional Date:11/01/99ISR Number: 3398843-9Report Type:Periodic Company Report #US_990725433 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa (Olanzapine) PS 40 MG / DAY Professional Date:11/01/99ISR Number: 3398845-2Report Type:Periodic Company Report #US_990725439 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Iron Deficiency Anaemia Health Zyprexa (Olanzapine) PS 20 MG / 1 DAY 10 DAY Professional Haldol C Cogentin C Remeron C Compazine C Levothyroxine C Tamoxifen C 24-Jun-2005 12:19 PM Page: 825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coenzyme C Erythromycin C Date:11/01/99ISR Number: 3398846-4Report Type:Periodic Company Report #US_990725285 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retinal Pigmentation Health Zyprexa (Olanzapine) PS 15 MG / 1 DAY 1 YR Visual Disturbance Professional Mellaril (Thioridazine Hydrochloride) C Paxil C Tegretol C Clonazepam C Amitriptyline C Lipitor C Furosemide C Levothyroxine C Albuterol C Combivent C Beclovent C Venceril C Imitrex C Trazodone C Date:11/01/99ISR Number: 3398847-6Report Type:Periodic Company Report #US_990725058 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Professional Depakote C Multivitamine W/Minerals C Date:11/01/99ISR Number: 3398848-8Report Type:Periodic Company Report #US_990724961 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/01/99ISR Number: 3398849-XReport Type:Periodic Company Report #US_990724965 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Precocious Puberty Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Professional Tegretol C Tenex C 24-Jun-2005 12:19 PM Page: 826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3398850-6Report Type:Periodic Company Report #US_990724576 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa (Olanzapine) PS 50 MG/1 DAY Professional Company Representative Date:11/01/99ISR Number: 3398851-8Report Type:Periodic Company Report #US_990724616 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nocturia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 2 YR Professional Date:11/01/99ISR Number: 3398852-XReport Type:Periodic Company Report #US_990624367 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatocellular Damage Health Zyprexa (Olanzapine) PS Professional Glyburide C Glucophage C Zocor C Prempro C Date:11/01/99ISR Number: 3398853-1Report Type:Periodic Company Report #US_990623992 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 4 DAY Professional Company Representative Date:11/01/99ISR Number: 3398854-3Report Type:Periodic Company Report #US_990623187 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Prozac (Fluoxetine Leukopenia Professional Hydrochloride) PS 60 MG DAY Zyprexa (Olanzapine) SS 5 MG DAY 5 WK Date:11/01/99ISR Number: 3398855-5Report Type:Periodic Company Report #US_990522743 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cyst Health Zyprexa (Olanzapine) PS 15 MG/ 1 AT Professional BEDTIME Company Zoloft C Representative Trazodone C 24-Jun-2005 12:19 PM Page: 827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3398856-7Report Type:Periodic Company Report #US_990420928 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Electrocardiogram Qt Professional Depakote C Prolonged Klonopin C Prolixin C Synthroid C Date:11/02/99ISR Number: 3388111-3Report Type:Expedited (15-DaCompany Report #EWC990603682 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Haematuria Health Depakine (Valproate Haemorrhage Professional Sodium) C Idiopathic Lormetazepam C Thrombocytopenic Purpura Date:11/02/99ISR Number: 3388112-5Report Type:Expedited (15-DaCompany Report #EWC990904328 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ascites Foreign Zyprexa (Olanzapine) PS Bleeding Varicose Vein Health Condition Aggravated Professional Hepatic Cirrhosis Other Hepatic Failure Hepatocellular Damage Date:11/02/99ISR Number: 3388122-8Report Type:Expedited (15-DaCompany Report #EWC991004619 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Other Murder Health Nitrazepam C Professional Other Date:11/02/99ISR Number: 3388125-3Report Type:Expedited (15-DaCompany Report #US_991029999 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Literature Zyprexa (Olanzapine) PS 10 MG/DAY 6 DAY Hospitalization - Chronic Obstructive Health Haloperidol C Initial or Prolonged Airways Disease Professional Exacerbated Disorientation Dysphagia Hyperhidrosis Hyperreflexia Muscle Rigidity Neuroleptic Malignant Syndrome Respiratory Failure Tremor Urinary Tract Infection 24-Jun-2005 12:19 PM Page: 828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/99ISR Number: 3388128-9Report Type:Expedited (15-DaCompany Report #AU_991000847 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 10 MG/AT Initial or Prolonged Akathisia Health BEDTIME Emotional Distress Professional Depo Provera Hostility Other (Medroxyprogesterone Intentional Misuse Acetate) C Tachycardia Venlafaxine C Vomiting Date:11/02/99ISR Number: 3388146-0Report Type:Expedited (15-DaCompany Report #US_990927856 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Muscle Rigidity Professional Lithium C Trazodone C Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Date:11/02/99ISR Number: 3388148-4Report Type:Expedited (15-DaCompany Report #GBS990603565 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa (Olanzapine) PS 5 MG AT Blood Creatine Health BEDTIME Phosphokinase Increased Professional Sinemet C Chills Other Entacapone (Comtess) C Confusional State Sotalol C Electrolyte Imbalance Diazepam C Erythema Heart Rate Increased Hyperhidrosis Hypertension Leukocytosis Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Refusal Of Treatment By Patient Urinary Tract Infection Date:11/02/99ISR Number: 3388192-7Report Type:Expedited (15-DaCompany Report #US_991030199 Age:25 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Coma Depressed Level Of Consciousness Hallucination Mydriasis 24-Jun-2005 12:19 PM Page: 829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS Professional Date:11/02/99ISR Number: 3388194-0Report Type:Expedited (15-DaCompany Report #US_991030278 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Hyperglycaemia Professional Albuterol C Prilosec (Omeprazole) C Cogentin (Benzatropine Mesilate) C Haldol (Haloperidol) C Klonopin (Clonazepam) C Date:11/02/99ISR Number: 3388196-4Report Type:Expedited (15-DaCompany Report #US_991030162 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Crepitations Professional Oedema Peripheral Company Pulmonary Oedema Representative Date:11/02/99ISR Number: 3388198-8Report Type:Expedited (15-DaCompany Report #US_991029766 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Rate Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Decreased Professional Lorazepam C Tachycardia Verapamil C Temazepam C Lanoxin (Digoxin) C Date:11/02/99ISR Number: 3388200-3Report Type:Expedited (15-DaCompany Report #US_981012665 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Zyprexa (Olanzapine) PS 20 MG DAY Akathisia Company Prolixin Anxiety Representative (Fluphenazine Blood Prolactin Increased Hydrochloride) C Breast Cancer Recurrent Valium (Diazepam) C Dementia Vistaril Full Blood Count (Hydroxyzine Decreased Hydrochloride) C Stupor Thinking Abnormal 24-Jun-2005 12:19 PM Page: 830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/99ISR Number: 3388203-9Report Type:Expedited (15-DaCompany Report #GBS991004457 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sinus Bradycardia Foreign Olanzapine PS 10 MG DAY Health Efexor (Venlafaxine Professional Hydrochloride) C Other Orovite C Thiamine C Date:11/02/99ISR Number: 3388204-0Report Type:Expedited (15-DaCompany Report #EWC991004592 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intracranial Pressure Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Increased Health Professional Date:11/02/99ISR Number: 3388207-6Report Type:Expedited (15-DaCompany Report #EWC991004593 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 26 MON Initial or Prolonged Increased Health Akineton (Biperiden Haematuria Professional Hydrochloride) C Thrombocytopenia Cisordinol (Clopenthixol Hydrochloride) C Date:11/02/99ISR Number: 3388251-9Report Type:Expedited (15-DaCompany Report #GBS981202090 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa(Olanzapine) PS 15 MG/1 DAY 18 MON Fall Consumer Gait Disturbance Health Gliosis Professional Hepatic Steatosis Company Hepatomegaly Representative Hypoxia Other Increased Appetite Laceration Nervous System Disorder Paraesthesia Pulmonary Congestion Sedation Weight Increased Date:11/02/99ISR Number: 3388254-4Report Type:Expedited (15-DaCompany Report #US_991029509 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa(Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Swelling Professional Risperdal(Risperidon Urticaria e) C 24-Jun-2005 12:19 PM Page: 831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/99ISR Number: 3388266-0Report Type:Expedited (15-DaCompany Report #DE_991001633 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Zyprexa (Olanzapine) PS Hospitalization - Cardiomyopathy Health Anafranil Initial or Prolonged Drug Interaction Professional (Clomipramine Disability Drug Toxicity Other Hydrochloride) C Echocardiogram Abnormal Severe Delusional Ejection Fraction Depression C Abnormal Antra (Omeprazole) C Hypokinesia Allopurinol C Left Ventricular Failure Pericardial Effusion Pneumonia Pulmonary Congestion Pyrexia Date:11/02/99ISR Number: 3388270-2Report Type:Expedited (15-DaCompany Report #DE_991001629 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa (Olanzapine) PS Hospitalization - Syndrome Health Fluanxol Initial or Prolonged Pulmonary Embolism Professional (Flupentixol Dihydrochloride) C Haldol (Haloperidol) C Lorazepam C Dalmadorm (Flurazepam Hydrochloride) C Date:11/02/99ISR Number: 3388272-6Report Type:Expedited (15-DaCompany Report #GBS991004467 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Neonatal Foreign Olanzapine PS Initial or Prolonged Cardiac Failure Health Dothiepin C Coma Professional Complications Of Maternal Exposure To Therapeutic Drugs Cyanosis Neonatal Dehydration Foetal Malposition Hypoglycaemia Neonatal Malaise Oedema Placental Disorder Pregnancy Respiratory Disorder Neonatal Umbilical Cord Abnormality 24-Jun-2005 12:19 PM Page: 832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/99ISR Number: 3388721-3Report Type:Expedited (15-DaCompany Report #EWC990603505 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Olanzapine PS 15 MG/DAY Initial or Prolonged Ascites Health Temesta (Lorazepam) C Blood Bilirubin Increased Professional Dominal Hepatic Enzyme Increased (Prothipendyl Hepatotoxicity Hydrochloride) C Jaundice Clotiapine C Date:11/03/99ISR Number: 3387731-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine 10 Mg (Lilly) PS Lilly ORAL 10-20MG/DAY PO Depakote C Loovral C Paxil C Fes04 C Cogentin C Thorazine C Klonopin C Ativan C Date:11/03/99ISR Number: 3389001-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001752 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Haldol (Unspecified) Hospitalization - Phosphokinase Increased Health (Haloperidol) PS MG, TOTAL, Initial or Prolonged Blood Pressure Increased Professional UNKNOWN Required Body Temperature Fluanxol Intervention to Increased (Flupentixol Prevent Permanent Bradyphrenia Dihydrochloride) SS STARTED IN Impairment/Damage Catatonia EARLY 1999. Cold Sweat Zyprexa (Olanzapine) SS MG, DAILY, Delusion UNKNOWN / 10 Hallucination, Auditory MG, 2 IN 1 Hypotension DAY(S), Leukocytosis UNKNOWN Lung Infiltration Temesta (Lorazepam) SS MG, TOTAL, Motor Dysfunction UNKNOWN/ MG, Mutism TOTAL, Neuroleptic Malignant UNKNOWN/ 1 Syndrome MG, 3 IN 1 Pleural Effusion Dalmadorm Pulmonary Embolism (Flurazepam Sinus Tachycardia Hydrochloride) SS MG, DAILY, Stereotypy UNKNOWN Stupor Akineton (Biperiden Syncope Hydrochloride) SS 2 MG, 4 IN 1 DAY(S), UNKNOWN Tenormin (Atenolol) SS 100 MG, 1 IN 1 DAY(S), UNKNOWN 24-Jun-2005 12:19 PM Page: 833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/99ISR Number: 3392994-0Report Type:Periodic Company Report #1999070012 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Carisoprodol + Initial or Prolonged Professional Aspirin PS ORAL 1 TAB Q8H, PO Zyprexa (Olanzapine) SS ORAL DATA NA, PO Neurontin (Gabapentin) SS ORAL DATA NA, PO Paxil (Paroxetine) C ORAL DATA NA, PO Pepcid C Armour Thyroid C Date:11/04/99ISR Number: 3395363-2Report Type:Periodic Company Report #9845070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Consumer Procardia Xl Hyperglycaemia Extended Release Hypertension Tablets PS ORAL 30.00 MG Pain TOTAL:DAILY:O Schizophreniform Disorder RAL Suicidal Ideation Zyprexa SS ORAL ORAL Weight Increased Toradol SS ORAL ORAL Synthroid C Zantac C Darvocet C Ativan C Date:11/05/99ISR Number: 3390174-6Report Type:Expedited (15-DaCompany Report #A0104288A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Lamictal Initial or Prolonged Drug Interaction Professional (Formulation Unknown Leukopenia ) (Lamotrigine) PS ORAL ORAL Neutropenia Valproic Acid Suicidal Ideation (Formulation White Blood Cell Count Unknown) (Valproic Decreased Acid) SS AT NIGHT Olanzapine (Formulation Unknown) (Olanzapine) SS 5 MG/ AT NIGHT Bupropion Hydrochloride C Clonazepam C Date:11/08/99ISR Number: 3391244-9Report Type:Expedited (15-DaCompany Report #US_991030267 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Haemoglobin Decreased Professional Influenza Company Leukaemia Representative White Blood Cell Count Decreased 24-Jun-2005 12:19 PM Page: 834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/99ISR Number: 3391249-8Report Type:Expedited (15-DaCompany Report #US_991030527 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa (Olanzapine) PS Inadequate Control Professional Lithium C Gestational Diabetes Klonopin (Clonazepam) C Zyprexa C Date:11/08/99ISR Number: 3391250-4Report Type:Expedited (15-DaCompany Report #AU_991000866 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Zyprexa (Olanzapine) PS 15 MG/AT Initial or Prolonged Intentional Misuse Health BEDTIME Other Nausea Professional Paraesthesia Other Suicidal Ideation Date:11/08/99ISR Number: 3391283-8Report Type:Expedited (15-DaCompany Report #GBS991004536 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Drug Interaction Health Valproate Sodium C Haemoglobin Decreased Professional Lorazepam C Neutropenia Company Platelet Count Decreased Representative Thrombocytopenia Other White Blood Cell Count Decreased Date:11/08/99ISR Number: 3391298-XReport Type:Expedited (15-DaCompany Report #EWC991004593 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 26 MON Initial or Prolonged Increased Health Akineton (Biperiden Haematuria Professional Hydrochloride) C Thrombocytopenia Other Cisordinol (Clopenthixol Hydrochloride) C Date:11/08/99ISR Number: 3391303-0Report Type:Expedited (15-DaCompany Report #EWC991004488 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Hyponatraemia Health Valium (Diazepam) C Inappropriate Professional Duphalac (Lactulose) C Antidiuretic Hormone Other Lansoyl (Paraffin, Secretion Liquid) C Pneumonitis Vomiting 24-Jun-2005 12:19 PM Page: 835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/99ISR Number: 3391305-4Report Type:Expedited (15-DaCompany Report #EWC990804068 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Hospitalization - Blood Creatine Health Initial or Prolonged Phosphokinase Increased Professional Disability Catatonia Other Coma Condition Aggravated Dehydration Disseminated Intravascular Coagulation Hyperpyrexia Leukocytosis Multi-Organ Failure Muscle Rigidity Myoglobin Blood Increased Neuroleptic Malignant Syndrome Quadriplegia Rhabdomyolysis Date:11/08/99ISR Number: 3391308-XReport Type:Expedited (15-DaCompany Report #US_990826831 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Health Zyprexa (Olanzapine) PS 15 MG/1 DAY MON Initial or Prolonged Necrosis Professional Trazodone C Pancreatitis Acute Eskalith Cr (Lithium Pleural Effusion Carbonate) C White Blood Cell Count Effexor (Venlafaxine Increased Hydrochloride) C Inderal (Propranolol Hydrochloride) C Promethazine C Morphine C Tylenol (Paracetamol) C Date:11/08/99ISR Number: 3391310-8Report Type:Expedited (15-DaCompany Report #US_991029766 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Condition Aggravated Professional Lorazepam C Insomnia Verapamil C Respiratory Rate Lanoxin C Decreased Temazepam C Schizophrenia Tachycardia Date:11/08/99ISR Number: 3391311-XReport Type:Expedited (15-DaCompany Report #US_990929125 Age:49 YR Gender:Male I/FU:F Outcome PT Other Convulsion Drug Interaction Drug Level Below 24-Jun-2005 12:19 PM Page: 836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Dilantin C Mellaril (Thioridazine Hydrochloride) C Date:11/08/99ISR Number: 3391398-4Report Type:Expedited (15-DaCompany Report #GBS981202090 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Ischaemia Foreign Zyprexa (Olanzapine) PS 15 MG/1 DAY 18 MON Gastritis Erosive Consumer Gliosis Health Hepatic Steatosis Professional Hepatomegaly Company Intentional Self-Injury Representative Laceration Other Meningeal Disorder Nervous System Disorder Pericardial Effusion Pulmonary Congestion Scar Spleen Disorder Date:11/08/99ISR Number: 3391403-5Report Type:Expedited (15-DaCompany Report #US_990928327 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Health Zyprexa (Olanzapine) PS 40 MG/1 DAY Hospitalization - Aphasia Professional Prilosec(Omeprazole) C Initial or Prolonged Blood Sodium Increased Blood Urea Increased Cardiac Arrest Coma Dehydration Loss Of Consciousness Sedation Date:11/08/99ISR Number: 3391406-0Report Type:Expedited (15-DaCompany Report #GBS991004432 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa(Olanzapine) PS Initial or Prolonged Prolonged Health Zolpidem C Intentional Misuse Professional Trimipramine C Neutrophil Count Increased Ventricular Hypertrophy White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/99ISR Number: 3391458-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Seroquel PS ORAL 400MG PO DAILY 1 MON Zyprexa SS ORAL 10MG PO DAILY (SERVERAL MONTHS) Depakene C Clonidine C Cogentin C Anafranil C Vistaril C Date:11/10/99ISR Number: 3391571-5Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Olanzapine PS UP TO 200MG Initial or Prolonged Professional X1 Hydroxyzine SS UP TO 1250MG X 1 Date:11/15/99ISR Number: 3398253-4Report Type:Expedited (15-DaCompany Report #US_991130609 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Airways Disease Professional Depakote C Other Exacerbated Klonopin C Convulsion Liver Function Test Abnormal Date:11/15/99ISR Number: 3398256-XReport Type:Expedited (15-DaCompany Report #GBS991104658 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Renal Infarct Health Thioridazine C Professional Sertraline C Other Trifluoperazine C Date:11/15/99ISR Number: 3398262-5Report Type:Expedited (15-DaCompany Report #EWC991004638 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Foreign Olanzapine PS 10 MG/DAY Initial or Prolonged Psychotic Disorder Health Fluoxetine C Professional 24-Jun-2005 12:19 PM Page: 838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/99ISR Number: 3398266-2Report Type:Expedited (15-DaCompany Report #DE_980500017 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Depression Literature Saroten C White Blood Cell Count Health ... C Decreased Professional ... C Other ... C ... C ... C ... C ... C Date:11/15/99ISR Number: 3398289-3Report Type:Expedited (15-DaCompany Report #GBS991104676 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Prozac (Fluoxetine Other Constipation Health Hydrochloride) PS 20 MG/DAY 3 WK Haematemesis Professional Zyprexa (Olanzapine) SS 10 MG/DAY 3 WK Myocardial Infarction Company Atenolol C Representative Temazepam C Date:11/15/99ISR Number: 3398529-0Report Type:Expedited (15-DaCompany Report #DE_990801435 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Depression Literature Amitriptyline C Neutropenia Health White Blood Cell Count Professional Decreased Other Date:11/15/99ISR Number: 3398532-0Report Type:Expedited (15-DaCompany Report #EWC991004593 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 26 MON Initial or Prolonged Increased Health Akineton (Biperiden Haematuria Professional Hydrochloride) C Thrombocytopenia Other Cisordinol (Clopenthixol Hydrochloride) C Date:11/15/99ISR Number: 3398535-6Report Type:Expedited (15-DaCompany Report #GBS990904204 Age:54 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Agitation Other Condition Aggravated Flight Of Ideas Histrionic Personality Disorder Insomnia Logorrhoea Mania 24-Jun-2005 12:19 PM Page: 839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroid Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 2.5 MG Health Lustral (Sertraline Professional Hydrochloride) C Other Date:11/15/99ISR Number: 3398538-1Report Type:Expedited (15-DaCompany Report #DE_991001629 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa (Olanzapine) PS Hospitalization - Syndrome Health Fluanxol Initial or Prolonged Pulmonary Embolism Professional (Flupentixol Other Dihydrochloride) C Haldol (Haloperidol) C Lorazepam C Dalmadorm (Flurazepam Hydrochloride) C Date:11/15/99ISR Number: 3398584-8Report Type:Expedited (15-DaCompany Report #US_991130825 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Convulsion Professional Other Depressed Level Of Consciousness Hepatic Enzyme Increased Hypotension Hypothermia Prothrombin Time Prolonged Date:11/16/99ISR Number: 3397424-0Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Below Health Olanzapine PS 7 DAY Therapeutic Professional Grand Mal Convulsion Date:11/16/99ISR Number: 3397433-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Health Olanzapine PS 5MG HS Carpal Tunnel Syndrome Professional Diazepam C Haematuria Psyllium C Pain Doxepin C Ranitidine C Buspirone C Trazodone C Polycarbophil C 24-Jun-2005 12:19 PM Page: 840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/99ISR Number: 3399104-4Report Type:Expedited (15-DaCompany Report #9911218 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Abbott- Depakene PS Abbott ORAL 1.000 GM PO Initial or Prolonged Epistaxis Health QD Haematuria Professional Olanzapine SS Purpura Other Olanzapine C Rectal Haemorrhage Lormetazepam C Thrombocytopenia Date:11/16/99ISR Number: 3399164-0Report Type:Expedited (15-DaCompany Report #9912646 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Back Pain Foreign Abbott - Depakene PS Abbott ORAL 2.000 GM PO Diarrhoea Health QD Drug Interaction Professional Olanzapine SS 10.000 MG UNK Ecchymosis Other QD Polyuria Olanzapine C Tranylcypromine C Disulfiram C Date:11/17/99ISR Number: 3398548-4Report Type:Direct Company Report # Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Zyprexa SS Date:11/17/99ISR Number: 3398601-5Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Valproic Acid 500mg And 250mg Tablets PS ORAL 750MG HS ORAL Olanzapine 10mg Tablet SS ORAL 10MG HS ORAL Date:11/18/99ISR Number: 3401656-2Report Type:Expedited (15-DaCompany Report #A0105387A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Lamictal Initial or Prolonged Blood Pressure Decreased Professional (Formulation Drug Interaction Company Unknown) Heart Rate Decreased Representative (Lamotrigine) PS ORAL 200 MG/TWICE PER DAY/ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS 5 MG/ PER DAY Risperidone C Lithium Salt C Venlafaxine Hydrochloride C Sinemet C 24-Jun-2005 12:19 PM Page: 841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/99ISR Number: 3404843-2Report Type:Expedited (15-DaCompany Report #AU_991100887 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Olanzapine PS 10 MG/2 DAY Initial or Prolonged Congestive Study Aspirin C Circulatory Collapse Health Cogentin Hypotension Professional (Benzatropine Other Mesilate) C Lithium C Adalat (Nifedipine) C Thiamine C Date:11/22/99ISR Number: 3404844-4Report Type:Expedited (15-DaCompany Report #EWC991104801 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Foreign Olanzapine PS 20 MG/DAY Hospitalization - Health Prazine (Promazine Initial or Prolonged Professional Hydrochloride) C Other Contraceptive Pill (Oral Contracepative Nos) C Date:11/22/99ISR Number: 3404845-6Report Type:Expedited (15-DaCompany Report #EWC991104788 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa(Olanzapine) PS 10 MG Initial or Prolonged Cholestasis Health Mindiab (Glipizide) C Professional Glucophage Other (Metformin Hydrochloride) C Litarex (Lithium Citrate) C Date:11/22/99ISR Number: 3404846-8Report Type:Expedited (15-DaCompany Report #GBS991104712 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa(Olanzapine) PS 10 MG/DAY Initial or Prolonged Electroencephalogram Health Clopixol Abnormal Professional (Zuclopenthixol Humerus Fracture Other Decanoate) C Eeg, Electroencephalaogra phy C Date:11/22/99ISR Number: 3404847-XReport Type:Expedited (15-DaCompany Report #EWC991104809 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa(Olanzapine) PS Health Prozac (Fluoxetine Professional Hydrochloride) SS Company Representative Other 24-Jun-2005 12:19 PM Page: 842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/99ISR Number: 3404898-5Report Type:Expedited (15-DaCompany Report #GBS990904138 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Aminotransferase Health Paroxetine C Initial or Prolonged Increased Professional Clonazepam C Blood Alcohol Increased Company Alprazolam C Blood Creatine Representative Lithium Carbonate C Phosphokinase Increased Blood Creatinine Increased Blood Glucose Increased Blood Ph Decreased Blood Urea Increased Cardiac Arrest Coma Diarrhoea Fibrosis Hepatic Steatosis Ketoacidosis Liver Disorder Overdose Pulmonary Congestion Pulmonary Oedema Sedation Supraventricular Tachycardia Ventricular Hypertrophy Weight Increased Date:11/22/99ISR Number: 3405683-0Report Type:Periodic Company Report #8-99225-114A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Effexor Xr PS ORAL 450 MG 1X PER 1 DAY, ORAL Lorazepam SS Zyprexa SS 10 MG DAILY Premarin (Conjugated Estrogens) C Lorazepam (Manufacturer Unknown) C Naprosyn (Naproxen) C Ambien (Zolpidem) C Zyprexa (Olanzapine) C Date:11/22/99ISR Number: 3405892-0Report Type:Expedited (15-DaCompany Report #US_991030405 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Zyprexa (Olanzapine) PS 5 MG/1 DAY 1 YR Recurrent Cancer Prozac (Fluoxetine Surgery Hydrochloride) SS 20 MG/1 DAY 5 YR 24-Jun-2005 12:19 PM Page: 843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/99ISR Number: 3405897-XReport Type:Expedited (15-DaCompany Report #US_991131151 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Health Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Cardiac Arrest Professional Prozac (Fluoxetine Initial or Prolonged Completed Suicide Hydrochloride) SS 20 MG/DAY Drug Level Above Dilaudid Therapeutic (Hydromorphone Suicidal Ideation Hydrochloride) C Alprazolam C Valproic Acid C Trazodone C Ibuprofen C Tamoxifen C Date:11/22/99ISR Number: 3405900-7Report Type:Expedited (15-DaCompany Report #US_991131005 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Foreign Zyprexa PS 10 MG/1 DAY Murder Health Midazolam C Physical Assault Professional Clonazepam C Date:11/22/99ISR Number: 3405916-0Report Type:Expedited (15-DaCompany Report #US_991130952 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Prozac (Fluoxetine Initial or Prolonged Mania Professional Hydrochloride) PS 20 MG/DAY 10 MON Zyprexa (Olanzapine) SS 5 MG/DAY 2 WK Depakene (Valproate Sodium) C Date:11/22/99ISR Number: 3415592-9Report Type:Periodic Company Report #S99-USA-01662-01 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Celexa PS ORAL 40MG QD PO Professional Meridia SS ORAL 15MG QOD PO Vicodin SS ORAL 5MG TID PO Diovan SS ORAL 80MG QD PO Detrol SS ORAL 2MG BID PO Lipitor SS ORAL 10MG QD PO Zyprexa SS ORAL 5MG QD PO Date:11/23/99ISR Number: 3405356-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Olanzapine PS 5MG QAM 10MG Phosphatase Increased HS 6 MON Blood Urea Increased 24-Jun-2005 12:19 PM Page: 844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406594-7Report Type:Periodic Company Report #USA/99/01336/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL; Initial or Prolonged Professional Zyprexa (Olanzapine) SS Synthroid (Levothyroxine Sodium) C Date:11/24/99ISR Number: 3409002-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999001894 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Haloperidol(Unspecif Initial or Prolonged Disinhibition Literature ied) (Haloperidol) PS MG, 1 DAY Euphoric Mood Health (S), 1 DAY Hypomania Professional Olanzapine Insomnia (Olanzapine) SS MG, DAILY, Persecutory Delusion Pressure Of Speech Psychotic Disorder Date:11/29/99ISR Number: 3409588-0Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa 15mg Qd - Rash Maculo-Papular Professional Lilly PS Lilly 10MG/5MG QHS Urticaria Navane C Cogentin C Date:11/29/99ISR Number: 3409677-0Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Olanzapine PS 10MG QHS Date:11/29/99ISR Number: 3409705-2Report Type:Expedited (15-DaCompany Report #EWC991104744 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Zyprexa(Olanzapine) PS 20 MG/DAY Hospitalization - Suicide Attempt Health Truxal Initial or Prolonged Professional (Chlorprothixene Company Hydrochloride) C Representative Date:11/29/99ISR Number: 3409708-8Report Type:Expedited (15-DaCompany Report #DE_991101742 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Zyprexa(Olanzapine) PS 10 MG/DAY Initial or Prolonged Hemiparesis Health Speech Disorder Professional Transient Ischaemic Attack 24-Jun-2005 12:19 PM Page: 845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/99ISR Number: 3409755-6Report Type:Expedited (15-DaCompany Report #US_991131668 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa (Olanzapine) PS 25 MG/1 DAY( Professional A FEW MONTHS) Haldol (Haloperidol) C Valproate Sodium C Temazepam C Date:11/29/99ISR Number: 3409764-7Report Type:Expedited (15-DaCompany Report #US_991131653 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa(Olanzapine) PS 10 MG/DAY 1 YR Initial or Prolonged Pancreatitis Professional Depakote (Valproate Weight Increased Semisodium) C Date:11/29/99ISR Number: 3409766-0Report Type:Expedited (15-DaCompany Report #US_991131367 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Olanzapine PS Initial or Prolonged Psychotic Disorder Professional Risperidone C Other Date:11/29/99ISR Number: 3409770-2Report Type:Expedited (15-DaCompany Report #GBS991104778 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Zyprexa(Olanzapine) PS 10 MG/DAY Initial or Prolonged White Blood Cell Count Health Cannabis C Other Decreased Professional Company Representative Date:11/29/99ISR Number: 3409896-3Report Type:Expedited (15-DaCompany Report #AU_991100909 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Olanzapine PS Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Convulsion Other Drug Withdrawal Syndrome Feeling Jittery Muscle Twitching Neonatal Disorder Date:11/29/99ISR Number: 3410012-2Report Type:Expedited (15-DaCompany Report #CA_991100905 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa (Olanzapine) PS 5 MG 2 MON Other Hypoventilation Health Serax C Pneumonia Professional Nitrodur Ii C 24-Jun-2005 12:19 PM Page: 846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/99ISR Number: 3410186-3Report Type:Expedited (15-DaCompany Report #EWC991104858 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Hyperthermia Malignant Health Largactil C Professional Tranxene C Other Esperal C Tiapridal C Deroxat C Zocor C Soprol C Lioresal C Date:11/29/99ISR Number: 3410187-5Report Type:Expedited (15-DaCompany Report #EWC991104851 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG Confusional State Health Seresta C Professional Esperal C Other Debridat C Atrium C Date:11/29/99ISR Number: 3410380-1Report Type:Expedited (15-DaCompany Report #US_991131151 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa (Olanzapine) PS 10 MG DAY Hospitalization - Drug Level Above Professional Prozac (Fluoxetine Initial or Prolonged Therapeutic Hydrochloride) SS 20 MG/DAY Suicidal Ideation Dilaudid (Hydromorphone Hydrochloride) C Alprazolam C Valproic Acid C Trazodone C Ibuprofen C Tamoxifen C Date:11/29/99ISR Number: 3410384-9Report Type:Expedited (15-DaCompany Report #US_990725336 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa(Olanzapine) PS 20 MG/1 DAY 3 MON Initial or Prolonged Blood Amylase Increased Health Delusion Professional Hallucination Other Leukocytosis Pancreatitis Date:11/29/99ISR Number: 3410387-4Report Type:Expedited (15-DaCompany Report #US_980707654 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Health Zyprexa (Olanzapine) PS 10 MG DAY Antepartum Haemorrhage Professional Prozac (Fluoxetine Sepsis Hydrochloride) SS 20 MG/DAY 24-Jun-2005 12:19 PM Page: 847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report A FEW YEARS Klonopin (Clonazepam) C Date:11/29/99ISR Number: 3410389-8Report Type:Expedited (15-DaCompany Report #GBS990904268 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Foreign Zyprexa (Olanzapine) PS Thrombocythaemia Health Aspirin C White Blood Cell Count Professional Sertraline C Increased Other Simvastatin C Gliclazide C Ventolin (Salbutamol) C Glyceryl Trinitrate C Date:11/29/99ISR Number: 3410393-XReport Type:Expedited (15-DaCompany Report #AU_991100887 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Olanzapine PS 10 MG/ 2 DAY Initial or Prolonged Congestive Study Aspirin C Circulatory Collapse Health Cogentin Hypotension Professional (Benzatropine Other Mesilate) C Lithium C Adalat (Nifedipine) C Thiamine C Date:11/29/99ISR Number: 3410398-9Report Type:Expedited (15-DaCompany Report #GBS991104676 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Prozac (Fluoxetine Circulatory Collapse Health Hydrochloride) PS 20 MG DAY 3 WK Constipation Professional Zyprexa (Olanzapine) SS 10 MG DAY 3 WK Haematemesis Company Atenolol C Myocardial Infarction Representative Temazepam C Other Trazodone C Date:11/29/99ISR Number: 3410430-2Report Type:Expedited (15-DaCompany Report #EWC991104940 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Automatism Foreign Zyprexa (Olanzapine) PS 10 MG / DAY Initial or Prolonged Disinhibition Health Leponex C Dyskinesia Professional Oral Intake Reduced Company Psychotic Disorder Representative Date:11/29/99ISR Number: 3410434-XReport Type:Expedited (15-DaCompany Report #EWC991104896 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Foreign Health 24-Jun-2005 12:19 PM Page: 848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Modecate C Valium C Rohypnol C Date:12/03/99ISR Number: 3413313-7Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Ethanol Increased Zyprexa PS ORAL 5MG Q H PO Nightmare Psychotic Disorder Date:12/03/99ISR Number: 3413322-8Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amenorrhoea Consumer Risperdal 2 Mg Am, Required Ovarian Cyst 3mg Pm, Depakote Intervention to Weight Increased 125mg Am, 500mg Pm Prevent Permanent Also Klowpin 0.5mg, Impairment/Damage Doxepin 50 Mg, PS RISPERDAL 2MGAM,3MGPM Depakote 125mg Am 500mg Pm SS 125MG AM, 500MG PM Klonopin 0.5mg SS 0.5MG Doxepin 50mg SS 50MG Olanzapine 5mg SS 5MG Mellarill 50 To 100mg SS 50 TO 100MG Progestin C Date:12/06/99ISR Number: 3413806-2Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa 15mg Qd Rash Maculo-Papular Professional Lilly PS Lilly 10MG/15MG QD Urticaria Navane C Cogentin C Date:12/06/99ISR Number: 3413984-5Report Type:Expedited (15-DaCompany Report #US_991130702 Age:54 YR Gender:Male I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Cellulitis Coordination Abnormal Drug Interaction Drug Level Above Therapeutic Eye Movement Disorder Oedema 24-Jun-2005 12:19 PM Page: 849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Sedation Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa(Olanzapine) PS 5 MG/1 DAY Professional Depakote C Other Carbamazepine C Phenobarbital C Amiloride C Haldol C Date:12/06/99ISR Number: 3413985-7Report Type:Expedited (15-DaCompany Report #US_991131754 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Zyprexa(Olanzapine) PS Eye Haemorrhage Professional Macular Degeneration Visual Acuity Reduced Date:12/06/99ISR Number: 3413986-9Report Type:Expedited (15-DaCompany Report #GBS991104824 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Paroxetine C Professional Lithium C Company Zuclopenthixol C Representative Valium C Date:12/06/99ISR Number: 3413988-2Report Type:Expedited (15-DaCompany Report #GBS991104850 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar Disorder Foreign Zyprexa(Olanzapine) PS 10 MG AS Blood Culture Positive Health NEEDED Coronary Artery Disease Professional Lithium C Leukopenia Other Trazodone C Lower Respiratory Tract Carbamazepine C Infection Diazepam C Neutrophil Count Zinacef C Increased Cephalexin C Pyrexia Lisinopril C Sepsis Lorazepam C White Blood Cell Count Frusemide C Decreased Gentamicin C Date:12/06/99ISR Number: 3413991-2Report Type:Expedited (15-DaCompany Report #EWC991104979 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa(Olanzapine) PS 5 MG/DAY Initial or Prolonged Loss Of Consciousness Health Aricept C Pallor Professional Potassium Ascorbate C Company Ativan C Representative Seroxat C Imovane C 24-Jun-2005 12:19 PM Page: 850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/99ISR Number: 3413994-8Report Type:Expedited (15-DaCompany Report #GBS991104823 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa (Olanzapine) PS Drug Level Above Health Zopicolone C Therapeutic Professional Phenelzine C Vomiting Other Date:12/06/99ISR Number: 3413998-5Report Type:Expedited (15-DaCompany Report #AU_991100919 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Zyprexa (Olanzapine) PS 10MG DAY Initial or Prolonged Health Professional Other Date:12/06/99ISR Number: 3414000-1Report Type:Expedited (15-DaCompany Report #CA_991100958 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Olanzapine PS 5MG DAY 1 WK Hypomania Health Lithium C Mania Professional Lorazepam C Other Date:12/06/99ISR Number: 3414011-6Report Type:Expedited (15-DaCompany Report #DE_991101765 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Health Professional Other Date:12/06/99ISR Number: 3414412-6Report Type:Expedited (15-DaCompany Report #EWC991104801 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Foreign Olanzapine PS 20 MG/DAY Hospitalization - Circulatory Collapse Health Prazine (Promazine Initial or Prolonged Dyspnoea Professional Hydrochloride) C Embolism Other Contraceptive Pill Fibrin D Dimer Increased (Oral Contraceptive Hypotonia Nos) C Pulmonary Embolism Tachycardia Date:12/06/99ISR Number: 3414655-1Report Type:Expedited (15-DaCompany Report #US_991132147 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Olanzapine PS Intentional Misuse Professional Company Representative 24-Jun-2005 12:19 PM Page: 851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/99ISR Number: 3415160-9Report Type:Expedited (15-DaCompany Report #US_991131965 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS 300 MG/1 DAY Initial or Prolonged Professional Company Representative Date:12/08/99ISR Number: 3415375-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Glucose Increased Health Olanzapine 20 & 10 G Required Hyperglycaemia Professional Tabs PS ORAL 30MG PO QHS Intervention to Medication Error Benadryl C Prevent Permanent Pollakiuria Monistat Vaginal Impairment/Damage Polydipsia Cream C Polyuria Psychotic Disorder Urge Incontinence Vaginal Disorder Date:12/08/99ISR Number: 3416442-7Report Type:Expedited (15-DaCompany Report #991206-SK856 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Torsade De Pointes Foreign Celebrex (Celecoxib) PS ORAL 200.000 MG Hospitalization - Ventricular Tachycardia Health Olanzapine Initial or Prolonged Professional (Olanzapine) SS ORAL 2.500 MG Other Date:12/08/99ISR Number: 3416669-4Report Type:Expedited (15-DaCompany Report #9949653 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zoloft Tablets PS ORAL ORAL Initial or Prolonged Hyperglycaemia Professional Zyprexa SS ORAL ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:12/10/99ISR Number: 3417895-0Report Type:Direct Company Report # Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lipids Abnormal Olanzapine 2.5 And Initial or Prolonged Weight Increased 7.5mg PS ORAL 2.5MG BID Other 7.5MG HS ORAL Paroxetine C 24-Jun-2005 12:19 PM Page: 852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/99ISR Number: 3420252-4Report Type:Expedited (15-DaCompany Report #GBS991104778 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Decreased Health Cannabis C Other Monocyte Count Decreased Professional Flupentixol C Psychotic Disorder Company Droperidol C White Blood Cell Count Representative Decreased Other Date:12/13/99ISR Number: 3420253-6Report Type:Expedited (15-DaCompany Report #EWC990904294 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Phosphokinase Increased Health Fluanxol Initial or Prolonged Catatonia Professional (Flupentixol Drug Toxicity Other Dihydrochloride) C Hypertension Temesta (Lorazepam) C Leukocytosis Dalmadorm Muscle Rigidity (Flurazepam Negativism Hydrochloride) C Pulmonary Embolism Haldol (Haloperidol C Pyrexia Stereotypy Stupor Tachycardia Date:12/13/99ISR Number: 3420551-6Report Type:Expedited (15-DaCompany Report #EWC991104987 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Respiratory Tract Health Madopar (Fluoxetine Initial or Prolonged Neoplasm Professional Hydrochloride) C Tuberculosis Company Jumex (Selegiline) C Representative Colfarit Other (Acetylsalicylic Acid) C Tensiomin (Captopril) C Rytmonorm (Propafenone Hydrochloride) C Date:12/13/99ISR Number: 3420553-XReport Type:Expedited (15-DaCompany Report #DE_991201803 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Schizophrenia Study Akineton (Biperiden Health Hydrochloride) C Professional Other 24-Jun-2005 12:19 PM Page: 853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/99ISR Number: 3420555-3Report Type:Expedited (15-DaCompany Report #US_991232271 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Consumer Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Dystonia Hypersensitivity Joint Stiffness Date:12/13/99ISR Number: 3420557-7Report Type:Expedited (15-DaCompany Report #US_991232245 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fibrosis Health Zyprexa (Olanzapine) PS Initial or Prolonged Pericardial Disease Professional Inderal (Propranolol Other Pericardial Excision Company Hydrochloride) C Representative Date:12/13/99ISR Number: 3420776-XReport Type:Expedited (15-DaCompany Report #EWC991105011 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Olanzapine PS 10 MG/DAY Initial or Prolonged Faecal Occult Blood Health Lorazepam C Positive Professional Trihyxyphenidyl C Faeces Discoloured Company Gastric Ulcer Representative Gastroenteritis Helicobacter Gastrointestinal Haemorrhage Haematemesis Haematochezia Haemoglobin Decreased Heart Rate Increased X-Ray Gastrointestinal Tract Abnormal Date:12/13/99ISR Number: 3420781-3Report Type:Expedited (15-DaCompany Report #GBS991104914 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Increased Health Chlorpromazine C Jaundice Professional Procyclidine C Chloral Hydrate C Prothiaden (Dosulepin) C Date:12/13/99ISR Number: 3420787-4Report Type:Expedited (15-DaCompany Report #EWC991104986 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Syncope Health Prozac(Fluoxetine Syncope Vasovagal Professional Hydrochloride) C Mepronizine C Lysanxia (Prazepam) C 24-Jun-2005 12:19 PM Page: 854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/99ISR Number: 3422714-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001752 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Haldol (Unspecified) Hospitalization - Phosphokinase Increased Health (Haloperidol) PS MG, TOTAL, Initial or Prolonged Bradyphrenia Professional UNKNOWN Required Catatonia Fluanxol Intervention to Cold Sweat (Flupentixol Prevent Permanent Condition Aggravated Dihydrochloride) SS STARTED IN Impairment/Damage Delusion EARLY 1999 Embolism Zyprexa (Olanzapine) SS 10 MG, 2 IN Hallucination, Auditory 1 DAY(S), Hypertension UNKNOWN Hypotension Temesta (Lorazepam) SS MG, TOTAL, Leukocytosis UNKNOWN; 1 Motor Dysfunction MG, 3 IN 1 Mutism DAY(S), Neuroleptic Malignant UNKNOWN Syndrome Dalmadorm Parkinson'S Disease (Flurazepam Pulmonary Embolism Hydrochloride) SS MG, DAILY, Pulmonary Infarction UNKNOWN Pyrexia Akineton (Biperiden Syncope Hydrochloride) SS 2 MG, 4 IN 1 Tachycardia DAY(S), UNKNOWN Tenormin (Atenolol) SS 100 MG, 1 IN 1 DAY(S), UNKNOWN Date:12/16/99ISR Number: 3422789-0Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa 20mg Qhs PS 20MG QHS Eye Movement Disorder Professional Zyprexa 15mg Qhs SS 15MG QHS Tegretol C Date:12/17/99ISR Number: 3425043-6Report Type:Expedited (15-DaCompany Report #HQ8458114DEC1999 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Rate Health Ativan Tablet PS ORAL 0.5 MG 2 X Initial or Prolonged Decreased Professional PER 1 DAY, Tachycardia ORAL Lanoxin SS ORAL 1 MG 1 X PER 1 DAY, ORAL Temazepam SS ORAL ORAL Verapamil SS ORAL 0.5 MG 2 X PER 1 DAY, ORAL Zyprexa SS ORAL 10 MG 1 X PER 1 DAY, ORAL Zyprexa SS ORAL 20 MG 1 X PER 1 DAY, ORAL 24-Jun-2005 12:19 PM Page: 855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/99ISR Number: 3428086-1Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Clozaril PS 1 DOSE ONLY Diabetes Mellitus (4 YEARS AGO) Zyprexa SS 5MG 2X/DAY Glyburide C Glucophage C Prevacid C Synthroid C Rmeron C Date:12/22/99ISR Number: 3428273-2Report Type:Expedited (15-DaCompany Report #EWC991205071 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zyprexa (Olanzapine) PS 20 MG/ DAY Initial or Prolonged Health Professional Other Date:12/22/99ISR Number: 3428274-4Report Type:Expedited (15-DaCompany Report #EWC991205047 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS 30 MG / DAY Initial or Prolonged Eczema Health Seborrhoeic Dermatitis Professional Date:12/22/99ISR Number: 3428276-8Report Type:Expedited (15-DaCompany Report #AU_991200932 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Zyprexa (Olanzapine) PS UNK Hospitalization - Health Initial or Prolonged Professional Date:12/22/99ISR Number: 3428279-3Report Type:Expedited (15-DaCompany Report #EWC991205114 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa (Olanzapine) PS 10 MG / DAY Initial or Prolonged Hepatitis Cholestatic Health Jaundice Professional Liver Function Test Other Abnormal Date:12/22/99ISR Number: 3428281-1Report Type:Expedited (15-DaCompany Report #EWC991205083 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa (Olanzapine) PS UNK Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/99ISR Number: 3428286-0Report Type:Expedited (15-DaCompany Report #US_990827181 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Autonomic Neuropathy Professional Mellaril C Blood Creatine Company Haldol C Phosphokinase Increased Representative Symmetrel C Depressed Level Of Ativan C Consciousness Serzone C Dyskinesia Depakote C Dysphagia Extrapyramidal Disorder Hyperhidrosis Hypertension Leukocytosis Muscle Rigidity Neuroleptic Malignant Syndrome Oculogyration Posturing Salivary Hypersecretion Tachycardia Trismus Urinary Incontinence Date:12/22/99ISR Number: 3428303-8Report Type:Expedited (15-DaCompany Report #GBS991204976 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sickle Cell Anaemia With Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Crisis Health Professional Date:12/22/99ISR Number: 3428308-7Report Type:Expedited (15-DaCompany Report #GBS991004528 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Faeces Foreign Olanzapine PS 30 MG/DAY Gastrointestinal Neoplasm Health Haloperidol C Neoplasm Professional Paracetamol C Overdose Other Amoxicillin C Platelet Count Decreased Pipotiazine C Thrombocytopenia Benzotropine C Flixotide C Salbutamol C Chlorpromazine C Theophylline C Prednisolone C Penicillin C Date:12/22/99ISR Number: 3428314-2Report Type:Expedited (15-DaCompany Report #GBS991205022 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Droperidol C Professional 24-Jun-2005 12:19 PM Page: 857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/99ISR Number: 3428319-1Report Type:Expedited (15-DaCompany Report #GBS991104910 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa (Olanzapine) PS 5 MG/DAY White Blood Cell Count Health Carbamazepine C Decreased Professional Date:12/22/99ISR Number: 3428322-1Report Type:Expedited (15-DaCompany Report #AU_991200970 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Olanzapine PS 20 MG/DAY White Blood Cell Count Health Prednisolone C Decreased Professional Hormone Replacement C Thyroxine C Date:12/22/99ISR Number: 3428477-9Report Type:Expedited (15-DaCompany Report #GBT991200203 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Delusion Study Epilim Chrono Drug Effect Decreased Health (Valproate Sodium) C Hallucination Professional Mania Other Mood Swings Paranoia Schizophreniform Disorder Date:12/23/99ISR Number: 3430123-5Report Type:Expedited (15-DaCompany Report #GBS991104850 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cold Sweat Foreign Zyprexa (Olanzapine) PS 10 MG AS Coronary Artery Disease Health NEEDED Differential White Blood Professional Lithium C Cell Count Abnormal Other Trazodone C Dyspnoea Carbamazepine C Haematemesis Diazepam C Lower Respiratory Tract Zinacef (Cefuroxime) C Infection Cephalexin C Neutropenia Lisinopril C Neutrophil Toxic Lorazepam C Granulation Present Frusemide C Pyrexia Gentamicin C Sepsis Date:12/23/99ISR Number: 3430127-2Report Type:Expedited (15-DaCompany Report #US_990826235 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Foreign Zyprexa (Olanzapine) PS 20 MG/1 DAY 18 MON Oedema Health Polydipsia Professional Other 24-Jun-2005 12:19 PM Page: 858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/99ISR Number: 3432398-5Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Olanzapine 10mg PS 10MG HS Movement Disorder Professional Diazepam C Muscle Twitching Date:12/28/99ISR Number: 3432612-6Report Type:Expedited (15-DaCompany Report #US_991030162 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Congestive Professional Effexor (Venlafaxine Cardiomegaly Company Hydrochloride C Cardiomyopathy Representative Tegretol Crepitations (Carbamazepine) C Oedema Peripheral Klonopin Pulmonary Oedema (Clonazepam) C Date:12/28/99ISR Number: 3432617-5Report Type:Expedited (15-DaCompany Report #US_991130825 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Convulsion Professional Other Depressed Level Of Consciousness Hepatic Enzyme Increased Hypotension Hypothermia Prothrombin Time Prolonged Date:12/28/99ISR Number: 3432621-7Report Type:Expedited (15-DaCompany Report #GBS991104824 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Adhesions Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Aortic Atherosclerosis Health Paroxetine C Atherosclerosis Professional Lithium C Bronchopneumonia Company Zuclopenthixol C Calcinosis Representative Valium (Diazepam) C Cardiomyopathy Other Cerebral Atherosclerosis Colon Cancer Coronary Artery Occlusion Hiatus Hernia Metastasis Nasopharyngitis Productive Cough Pulmonary Oedema Scleral Disorder Spleen Disorder 24-Jun-2005 12:19 PM Page: 859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/99ISR Number: 3432627-8Report Type:Expedited (15-DaCompany Report #US_991232920 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Health Zyprexa (Olanzapine) PS Professional Effexor (Venlafaxine Company Hydrochloride) C Representative Date:12/28/99ISR Number: 3432630-8Report Type:Expedited (15-DaCompany Report #DE_991201803 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Schizophrenia Study Akineton (Biperiden Health Hydrochloride) C Professional Date:12/28/99ISR Number: 3432632-1Report Type:Expedited (15-DaCompany Report #EWC990904229 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Hepatitis Health Stilnox (Zolpidem) C Hepatocellular Damage Professional Jaundice Other Liver Function Test Abnormal Pyrexia Date:12/28/99ISR Number: 3432720-XReport Type:Expedited (15-DaCompany Report #EWC991104813 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Platelet Count Decreased Health Largactil Professional (Chlorpromazine Other Hydrochloride) C Piportil (Pipotiazine) C Atrium C Date:12/28/99ISR Number: 3432806-XReport Type:Expedited (15-DaCompany Report #US_991233204 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Literature Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Thinking Abnormal Health Professional Date:12/28/99ISR Number: 3432809-5Report Type:Expedited (15-DaCompany Report #AU_991200939 Age: Gender:Male I/FU:I Outcome PT Report Source Death Convulsion Foreign Health Professional 24-Jun-2005 12:19 PM Page: 860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 25 MG/DAY Date:12/28/99ISR Number: 3432813-7Report Type:Expedited (15-DaCompany Report #DE_991201851 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Delirium Health Quilonum C Diabetes Mellitus Professional Hyperglycaemia Other Liver Function Test Abnormal Mental Disorder Date:12/28/99ISR Number: 3432817-4Report Type:Expedited (15-DaCompany Report #GBS991205029 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Cholangitis Health Fluoxetine C Cholangitis Sclerosing Professional Cholecystitis Company Delusion Representative Haematuria Other Hallucination, Auditory Ill-Defined Disorder Insomnia Post Procedural Complication Vision Blurred Weight Increased Date:12/28/99ISR Number: 3432843-5Report Type:Expedited (15-DaCompany Report #US_991232959 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 06 6 WK Initial or Prolonged Phosphokinase Increased Professional Lithium C Blood Creatinine Valproic Acid C Increased Drug Toxicity Pyrexia Date:12/28/99ISR Number: 3432848-4Report Type:Expedited (15-DaCompany Report #US_991233035 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Phosphatase Increased Professional Depakote C Other Coma Klonopin C Hyperglycaemia Vitamin B C Ketoacidosis 24-Jun-2005 12:19 PM Page: 861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/99ISR Number: 3432874-5Report Type:Expedited (15-DaCompany Report #US_991233059 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Prozac (Fluoxetine Hospitalization - Depression Professional Hydrochloride) PS 20 MG/1 DAY Initial or Prolonged Diabetic Complication Zyprexa (Olanzapine) SS 7.5 MG/1 DAY Increased Appetite Glucophage C Insomnia Klonopin C Restlessness Diabeta C Urinary Incontinence Risperdal C Benadryl C Date:12/29/99ISR Number: 3433062-9Report Type:Direct Company Report # Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Zyprexa 10mg Hs Po PS ORAL 10MG HS PO 3 WK Fungal Skin Infection Micronase C Hyperphagia Gucophage C Increased Appetite Polyuria Weight Increased Date:12/29/99ISR Number: 3433085-XReport Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Prolactin Increased Zyprexa 5 And 10mg PS ORAL 5 MG PO Intervention to Chest Pain HS;10MG PO Prevent Permanent Diabetes Mellitus HS; 5MG PO HS Impairment/Damage Inadequate Control Tluvaxamine C Dyspnoea Ferosimide C Hyperglycaemia Topiramate C Lethargy Docygate C Oedema Peripheral Pancyhemalal C Pyrexia Kcl C Lasix C Asa C Caco C Vit D C Date:01/04/00ISR Number: 3435370-4Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Olanzapine 5mg PS ORAL 5MG PO BID Initial or Prolonged Headache Olanzapine 5mg SS ORAL 5MG PO QD Hyperhidrosis Liver Function Test Abnormal Muscular Weakness Pyrexia Thinking Abnormal 24-Jun-2005 12:19 PM Page: 862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/00ISR Number: 3436075-6Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Zyprexa Initial or Prolonged Dizziness (Olanzapine)10mg Tab PS ORAL 1 TAB PO QHS Loss Of Consciousness Buspar C Tremor Risperdal C Date:01/06/00ISR Number: 3439058-5Report Type:Expedited (15-DaCompany Report #GBS991205022 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Droperidol C Professional Other Date:01/06/00ISR Number: 3439060-3Report Type:Expedited (15-DaCompany Report #EWC990904316 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Systolic Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Life-Threatening Decreased Health Loxapac (Loxapine Hospitalization - Coma Professional Succinate) C Initial or Prolonged Diarrhoea Company Athymil (Mianserin Disseminated Representative Hydrochloride) C Intravascular Coagulation Other Depamide Ecchymosis (Valpromide) C Fall Tranxene Fibrin Degradation (Clorazepate Products Increased Dipotassium) C Gastrointestinal Haemorrhage Heart Rate Increased Hyperthermia Malignant Intestinal Infarction Lactic Acidosis Multi-Organ Failure Petechiae Prothrombin Level Decreased Purpura Renal Failure Acute Rhabdomyolysis Shock Thrombocytopenia Date:01/06/00ISR Number: 3439061-5Report Type:Expedited (15-DaCompany Report #US_991130609 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Airways Disease Professional Depokate (Valproate Other Exacerbated Semisodium) C Convulsion Klonopin Liver Function Test (Clonazepam) C Abnormal Ast/Sgot, Aspartate Aminotransferase C 24-Jun-2005 12:19 PM Page: 863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ldh, Lactic Dehydrogenase C Alt/Sgpt, Alanine Aminotransferase C Date:01/06/00ISR Number: 3439063-9Report Type:Expedited (15-DaCompany Report #GBS991004528 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Foreign Olanzapine PS 30 MG/DAY Overdose Health Haloperidol C Swelling Professional Paracetamol C Thrombocytopenia Other Amoxicillin C Pipotiazine C Benzotropine (Benzatropine Mesilate) C Flixotide (Fluticasone Propionate) C Salbutamol C Chlorpromazine C Theophylline C Prednisolone C Penicillin C Date:01/06/00ISR Number: 3439064-0Report Type:Expedited (15-DaCompany Report #US_990927865 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa (Olanzapine) PS 10 MG Drug Level Above Professional Carbamazepine C Therapeutic Lorazepam C Intentional Misuse Cyanocobalamin C Oedema Benztropine C Pulmonary Congestion Pulmonary Oedema Date:01/06/00ISR Number: 3439065-2Report Type:Expedited (15-DaCompany Report #US_990928114 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Zyprexa (Olanzapine) PS 15 MG/1 AT Initial or Prolonged Anion Gap Increased Professional BEDTIME Blood Amylase Increased Company Inderal (Propranolol Blood Ketone Body Representative Hydrochloride) C Increased Sertraline C Diabetic Ketoacidosis Buspirone C Hyperglycaemia Ketoacidosis Ketonuria Lipase Increased Mucosal Dryness Pancreatitis Polydipsia Polyuria Tachycardia Vomiting 24-Jun-2005 12:19 PM Page: 864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/00ISR Number: 3439094-9Report Type:Expedited (15-DaCompany Report #DE_991201879 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depression Foreign Zyprexa (Olanzapine) PS 10 MG DAY Hospitalization - Pulmonary Embolism Study Saroten - Slow Initial or Prolonged Health Release Professional (Amitriptyline Other Hydrochloride) C Radepur (Chlordiazepoxide) C Risperdal (Risperidone) C Date:01/06/00ISR Number: 3439095-0Report Type:Expedited (15-DaCompany Report #US_991233336 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Necrosis Health Zyprexa (Olanzapine) PS Pancreatic Disorder Professional Pancreatitis Company Representative Date:01/06/00ISR Number: 3439097-4Report Type:Expedited (15-DaCompany Report #US_991233345 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Necrosis Health Zyprexa (Olanzapine) PS Initial or Prolonged Pancreatic Disorder Professional Pancreatitis Company Representative Date:01/06/00ISR Number: 3439098-6Report Type:Expedited (15-DaCompany Report #AU_991201028 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Olanzapine PS 20 MG DAY Health Professional Other Date:01/06/00ISR Number: 3439102-5Report Type:Expedited (15-DaCompany Report #DE_991201881 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Epistaxis Health Tagonis (Paroxetine Professional Hydrochloride) C Other Ferro Sanol C Date:01/06/00ISR Number: 3439105-0Report Type:Expedited (15-DaCompany Report #DE_991201884 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Lymphopenia Foreign Weight Increased Health Professional 24-Jun-2005 12:19 PM Page: 865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 15 MG DAY Pipamperone C Date:01/06/00ISR Number: 3439108-6Report Type:Expedited (15-DaCompany Report #US_991233282 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Periorbital Haematoma Study Olanzapine PS 2 DSG FORM Initial or Prolonged Road Traffic Accident Health DAY Swelling Professional Aricept (Donepezil Hydrochloride) C Date:01/06/00ISR Number: 3439111-6Report Type:Expedited (15-DaCompany Report #DE_991201875 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Psychotic Disorder Study Leponex (Clozapine) C Health Taxilan (Perazine) C Professional Other Date:01/06/00ISR Number: 3439113-XReport Type:Expedited (15-DaCompany Report #DE_991201866 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG 2 DAY Initial or Prolonged Health Professional Other Date:01/06/00ISR Number: 3439120-7Report Type:Expedited (15-DaCompany Report #EWC990703821 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Fibrinogen Foreign Zyprexa (Olanzapine) PS 20 MG DAY Initial or Prolonged Increased Health Cipramil C-Reactive Protein Professional (Citalopram) C Increased Other Tranxene Coagulopathy (Clorazepate Liver Function Test Dipotassium) C Abnormal Staurodorm C Nausea Vomiting Date:01/06/00ISR Number: 3439128-1Report Type:Expedited (15-DaCompany Report #EWC991205200 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Death Completed Suicide Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG DAY Date:01/06/00ISR Number: 3439130-XReport Type:Expedited (15-DaCompany Report #GBS990703720 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basophilia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Chronic Myeloid Leukaemia Health Sertraline C Diabetes Mellitus Professional Serum Cholesterol Non-Insulin-Dependent Other Levels C Eosinophilia Infection Laceration Neutrophilia Self Mutilation White Blood Cell Count Increased Date:01/06/00ISR Number: 3439134-7Report Type:Expedited (15-DaCompany Report #US_990725399 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Health Zyprexa (Olanzapine) PS 15 MG/ 1 AT Initial or Prolonged Diabetic Ketoacidosis Professional BEDTIME Hepatic Enzyme Increased Company Propranolol C Hyperglycaemia Representative Buspar (Buspirone Mucous Membrane Disorder Other Hydrochloride) C Pancreatitis Tachycardia Weight Increased Date:01/06/00ISR Number: 3439171-2Report Type:Expedited (15-DaCompany Report #M0800-99 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Remeron PS ORAL 1 TABLET/DAY Initial or Prolonged Abnormal Health PO Other Professional Zyprexa SS Other Date:01/06/00ISR Number: 3439305-XReport Type:Expedited (15-DaCompany Report #US_991131625 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS 30 MG/1 AT Initial or Prolonged Liver Function Test Professional BEDTIME Abnormal Lithobid (Lithium Pneumonia Carbonate) C Suicide Attempt Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Mellaril (Thioridazine 24-Jun-2005 12:19 PM Page: 867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Desyrel (Trazodone Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Lipitor (Atorvastatin) C Ambien (Zolpidem Tartrate) C Axid (Nizatidine) C Motrin (Ibuprofen) C Date:01/06/00ISR Number: 3439306-1Report Type:Expedited (15-DaCompany Report #US_991131624 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 10 MG/1 AT Professional BEDTIME Risperdal (Risperidone) C Serzone (Nefazodone Hydrochloride) C Depakote (Valproate Semisodium) C Date:01/06/00ISR Number: 3439307-3Report Type:Expedited (15-DaCompany Report #US_991131623 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Zyprexa (Olanzapine) PS 10 MG/1 AT Hospitalization - Blood Creatinine Professional BEDTIME Initial or Prolonged Increased Lithium C Blood Urea Increased Confusional State Decreased Appetite Diarrhoea Drug Toxicity Fatigue Leukocytosis Oliguria Renal Failure Acute Thrombocythaemia Vomiting Date:01/06/00ISR Number: 3439310-3Report Type:Expedited (15-DaCompany Report #US_991131619 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa (Olanzapine) PS 20 MG/1 AT Other Cardio-Respiratory Arrest Professional BEDTIME Convulsion Depakote (Valproate Semisodium) C Clozaril (Clozapine) C 24-Jun-2005 12:19 PM Page: 868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/00ISR Number: 3439311-5Report Type:Expedited (15-DaCompany Report #US_991131614 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 10 MG/3 DAY Overdose Professional Cogentin (Benzatropine Mesilate) C Trilafon (Perphenazine) C Micronase (Glibenclamide) C Premarin (Estrogens Conjugated) C Risperdal(Risperidon e) C Zestril (Lisinopril) C Date:01/06/00ISR Number: 3439312-7Report Type:Expedited (15-DaCompany Report #US_991233261 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Zyprexa (Olanzapine) PS 10 MG Intentional Misuse Luvox (Fluvoxamine Maleate) C Hydrocodone C Xanax (Alprazolam) C Depakote (Valproate Semisodium) C Celexa (Citalopram Hydrobromide) C Date:01/06/00ISR Number: 3439313-9Report Type:Expedited (15-DaCompany Report #US_991233233 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Hepatomegaly Professional Jaundice Date:01/12/00ISR Number: 3443360-0Report Type:Expedited (15-DaCompany Report #US_000133468 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Health Zyprexa (Olanzapine) PS Toxic Epidermal Professional Valproic Acid C Necrolysis Date:01/12/00ISR Number: 3443365-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Olanzapine 10mg Hospitalization - Lilly PS Lilly ORAL 20MG HS ORAL Initial or Prolonged Valproic Acid 250mg Abbott SS Abbott ORAL 750MG AM/1000MG HS ORAL 24-Jun-2005 12:19 PM Page: 869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Folic Acid C Vit E C Date:01/12/00ISR Number: 3443373-9Report Type:Expedited (15-DaCompany Report #EWC000105274 Age:48 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Phosphokinase Increased Health Effexor (Venlafaxine Hepatic Enzyme Increased Professional Hydrochloride) C Hepatitis Other Nausea Date:01/12/00ISR Number: 3443486-1Report Type:Expedited (15-DaCompany Report #EWC000105272 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Increased Health Serenase Hepatomegaly Professional (Haloperidol) C Weight Increased Other Diapam (Diazepam) C Kestine (Ebastine) C Date:01/12/00ISR Number: 3443535-0Report Type:Expedited (15-DaCompany Report #EWC991104986 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Condition Aggravated Health Prozac (Fluoxetine Syncope Professional Hydrochloride) C Syncope Vasovagal Other Mepronizine C Lysanxia (Prazepam) C Haldol (Haloperidol) C Artane (Trihexyphenidyl Hydrochloride) C Date:01/12/00ISR Number: 3443537-4Report Type:Expedited (15-DaCompany Report #DE_991201851 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Diabetes Mellitus Health Quilonum (Lithium Inadequate Control Professional Acetate) C Diabetic Coma Other Hyperglycaemia Liver Function Test Abnormal Psychotic Disorder Sedation 24-Jun-2005 12:19 PM Page: 870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/00ISR Number: 3443723-3Report Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Olanzapine PS Intervention to Prevent Permanent Impairment/Damage Date:01/14/00ISR Number: 3443867-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombocytopenia Olanzapine /10mg Hospitalization - Tablets / PS ORAL 20MG HS ORAL Initial or Prolonged Depakote 250mg Tablets SS ORAL 750MG AM 1000MG HS ORAL Lithium C Levothyroxine C Vitamin E C Folic Acid C Date:01/18/00ISR Number: 3444924-0Report Type:Expedited (15-DaCompany Report #US_000133626 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Zyprexa (Olanzapine) PS 10 MG/1 DAY Increased Date:01/18/00ISR Number: 3444925-2Report Type:Expedited (15-DaCompany Report #EWC000105355 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Purpura Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Rash Vesicular Health Prothiaden Professional (Dosulepin) C Cipramil (Citalopram)* C Xanax (Alprazolam) C Date:01/18/00ISR Number: 3444926-4Report Type:Expedited (15-DaCompany Report #US_000133621 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa (Olanzapine) PS Professional Date:01/18/00ISR Number: 3445055-6Report Type:Expedited (15-DaCompany Report #US_991232959 Age:47 YR Gender:Male I/FU:F Outcome PT Life-Threatening Aortic Thrombosis Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Coagulopathy 24-Jun-2005 12:19 PM Page: 871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Diabetic Hyperosmolar Coma Report Source Product Role Manufacturer Route Dose Duration Drug Toxicity Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Gangrene Professional Lithium C Hyperpyrexia Valproic Acid C Hypertension Vasotec C Leukocytosis Clonazepam C Muscle Rigidity Niaspan C Nephrogenic Diabetes Indocin C Insipidus Neuroleptic Malignant Syndrome Peripheral Ischaemia Peripheral Vascular Disorder Tachycardia Tachypnoea Date:01/18/00ISR Number: 3445061-1Report Type:Expedited (15-DaCompany Report #US_000133632 Age:18 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Zyprexa (Olanzapine) PS 600 MG/1 DAY Initial or Prolonged Hypertension Professional Date:01/18/00ISR Number: 3445063-5Report Type:Expedited (15-DaCompany Report #DE_000101899 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Foreign Zyprexa (Olanzapine) PS 2 MON Initial or Prolonged Haemoglobin Decreased Health Haemolytic Anaemia Professional Leukopenia Mean Cell Volume Increased Thrombocytopenia Date:01/18/00ISR Number: 3445065-9Report Type:Expedited (15-DaCompany Report #US_000133742 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa (Olanzapine) PS 30 MG/1 DAY Congestive Professional Prozac (Fluoxetine Dyspnoea Hydrochloride) SS 60 MG/1 DAY Weight Increased Date:01/18/00ISR Number: 3445067-2Report Type:Expedited (15-DaCompany Report #AU_991000828 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Olanzapine PS 5 MG/DAY White Blood Cell Count Health Efexor C Decreased Professional Alprazolam C Temazepam C 24-Jun-2005 12:19 PM Page: 872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/00ISR Number: 3445857-6Report Type:Expedited (15-DaCompany Report #US_991131536 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa (Olanzapine) PS 150 MG/1 DAY Initial or Prolonged Agitation Professional Dysarthria Other Intentional Misuse Mental Impairment Suicide Attempt Date:01/18/00ISR Number: 3445863-1Report Type:Expedited (15-DaCompany Report #GBS000105153 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa (Olanzapine) PS 5 MG/DAY White Blood Cell Count Health Decreased Professional Other Date:01/18/00ISR Number: 3445864-3Report Type:Expedited (15-DaCompany Report #EWC990804090 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cholecystitis Foreign Olanzapine PS Hospitalization - Dysuria Study Apranax (Naproxen Initial or Prolonged Hepatic Pain Health Sodium) C Inflammation Professional Niflugel (Niflumic Mania Other Acid) C Pain Dafalgan Phlebitis (Paracetamol) C Prostatitis Depakine Chrono C Pulmonary Embolism Prozac (Fluoxetine Pyrexia Hydrochloride ) C Sepsis Fraxiparine Urinary Tract Infection (Heparin-Fraction, Calcium Salt) C Date:01/18/00ISR Number: 3446464-1Report Type:Expedited (15-DaCompany Report #US_991131653 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa (Olanzapine) PS 10 MG/DAY 1 YR Initial or Prolonged Pancreatitis Professional Depakote (Valproate Weight Increased Semisodium) C Date:01/18/00ISR Number: 3446466-5Report Type:Expedited (15-DaCompany Report #GBS990703720 Age:62 YR Gender:Female I/FU:F Outcome PT Other Basophilia Chronic Myeloid Leukaemia Condition Aggravated Diabetes Mellitus Non-Insulin-Dependent Infection Intentional Self-Injury Laceration 24-Jun-2005 12:19 PM Page: 873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophilia Thrombocythaemia White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Sertraline C Professional Aspirin C Company Atorvastatin C Representative Other Date:01/18/00ISR Number: 3446468-9Report Type:Expedited (15-DaCompany Report #DE_991101742 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Hemiparesis Health Contraceptivum E C Speech Disorder Professional Transient Ischaemic Other Attack Weight Increased Date:01/19/00ISR Number: 3445725-XReport Type:Expedited (15-DaCompany Report #US_991232238 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Nervous System Health Zyprexa (Olanzapine) PS 2.5 MG/ 1 AT Hospitalization - Imbalance Professional BEDTIME Initial or Prolonged Blood Creatine Company Celexa (Citalopram Phosphokinase Increased Representative Hydrobromide) C Chorea Wellbutrin Sr Delirium (Amfebutamone Dyskinesia Hydrochloride) C Dysphagia Neurontin Extrapyramidal Disorder (Gabapentin) C Hyperhidrosis Symmetrel Hypertension (Amantadine Leukocytosis Hydrochloride) C Muscle Rigidity Neuroleptic Malignant Syndrome Parkinsonian Gait Pyrexia Tachycardia Tachypnoea Date:01/21/00ISR Number: 3445552-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Olanzapine PS 20MG QD 5 ML Professional 24-Jun-2005 12:19 PM Page: 874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/00ISR Number: 3445561-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Olanzapine PS 15 MG QD Professional Date:01/21/00ISR Number: 3445563-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Clonic Convulsion Health Olanzapine PS 10 MG BID Intervention to Grand Mal Convulsion Professional Prevent Permanent Impairment/Damage Date:01/21/00ISR Number: 3445564-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocythaemia Health Olanzapine PS 5 MG BID 15 MON Professional Date:01/21/00ISR Number: 3445566-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Olanzapine PS 5 MG BID 11 MON Abnormal Professional Date:01/21/00ISR Number: 3445572-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Olanzapine PS 5 MG QAM 10MG Professional QHS 11 MON Date:01/21/00ISR Number: 3521060-6Report Type:Periodic Company Report #1999SUS1351 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Sustiva PS Dupont Professional Pharmaceuticals Co ORAL PO Zyprexa SS Date:01/24/00ISR Number: 3446084-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Disability Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Zyprexa PS 2 MG ONCE Aortic Occlusion DAILY Coagulopathy Lithium SS 300 MG 5X/DAY Coma Vasotec C Decreased Activity Niapsan C Diabetes Mellitus Clonazepam C Drug Interaction Paxil C Dry Mouth Embolism Foot Amputation Gallbladder Disorder Gangrene Hyperglycaemia Hyperpyrexia Renal Impairment Skin Discolouration Stupor Surgery Vision Blurred Vomiting Weight Increased Date:01/24/00ISR Number: 3446524-5Report Type:Expedited (15-DaCompany Report #GBS000105174 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Captopril C Professional Folic Acid C Other Aspirin C Temazepam C Oxybutynin C Date:01/24/00ISR Number: 3446526-9Report Type:Expedited (15-DaCompany Report #EWC000105440 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa (Olanzapine) PS Health Professional Company Representative Other Date:01/24/00ISR Number: 3446545-2Report Type:Expedited (15-DaCompany Report #US_991232245 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fibrosis Health Zyprexa (Olanzapine) PS Initial or Prolonged Pericardial Disease Professional Inderal (Propranolol Other Company Hydrochloride) C Representative 24-Jun-2005 12:19 PM Page: 876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/00ISR Number: 3446546-4Report Type:Expedited (15-DaCompany Report #EWC991205200 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 15 MG/1 DAY Intentional Misuse Health Professional Company Representative Other Date:01/24/00ISR Number: 3446547-6Report Type:Expedited (15-DaCompany Report #AU_991000828 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Olanzapine PS 5 MG/DAY Neutropenia Health Efexor (Venlafaxine Professional Hydrochloride) C Other Alprazolam C Temazepam C Date:01/24/00ISR Number: 3446564-6Report Type:Expedited (15-DaCompany Report #US_991232920 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Effexor (Venlafaxine Company Hydrochloride) C Representative Tegretol (Carbamazepine) C De[Akote (Valproate Sodium) C Date:01/24/00ISR Number: 3446567-1Report Type:Expedited (15-DaCompany Report #US_991233282 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematoma Study Olanzapine PS 2 DSG FORM Initial or Prolonged Periorbital Oedema Health DAY Road Traffic Accident Professional Aricept (Donepezil Hydrochloride) C Date:01/24/00ISR Number: 3446589-0Report Type:Expedited (15-DaCompany Report #US_990421242 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa (Olanzapine) PS 25 MG/1 DAY Nephrolithiasis Health Nightmare Professional Pain In Extremity Pruritus Genital 24-Jun-2005 12:19 PM Page: 877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/00ISR Number: 3446590-7Report Type:Expedited (15-DaCompany Report #US_991232697 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Health Zyprexa (Olanzapine) PS 10 MG/DAY 3 WK Aminotransferase Professional Zoloft (Sertraline Increased Company Hydrochloride) C Atrophy Representative Blood Chloride Decreased Blood Sodium Abnormal Brain Scan Abnormal Convulsion Encephalopathy Nervous System Disorder Sinusitis Date:01/24/00ISR Number: 3446592-0Report Type:Expedited (15-DaCompany Report #US_000134052 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Weight Increased Professional Prolixin Decanoate Other Company (Fluphenazine Representative Decanoate) C Date:01/24/00ISR Number: 3446594-4Report Type:Expedited (15-DaCompany Report #GBS000105168 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activated Partial Foreign Zyprexa (Olanzapine) PS SCHIZOPHRENIA Thromboplastin Time Health Chlorpromazine C Prolonged Professional Coagulopathy Company Haemoglobin Decreased Representative International Normalised Ratio Decreased Prothrombin Time Shortened White Blood Cell Count Decreased Date:01/24/00ISR Number: 3446599-3Report Type:Expedited (15-DaCompany Report #US 000134226 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa (Olanzapine) PS 20 MG/ DAY Professional Depakote C Neurontin C Date:01/24/00ISR Number: 3446602-0Report Type:Expedited (15-DaCompany Report #US-000133934 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Confusional State Pyrexia Tremor 24-Jun-2005 12:19 PM Page: 878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Professional Date:01/24/00ISR Number: 3446605-6Report Type:Expedited (15-DaCompany Report #GBT000100212 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Medication Error Study Amisulpride C Persecutory Delusion Health Epilim Chrono Psychiatric Symptom Professional (Valproate Sodium) C Schizophrenia Other Clonazepam C Date:01/24/00ISR Number: 3446607-XReport Type:Expedited (15-DaCompany Report #AU-000101044 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Olanzapine PS 7.5 MG/DAY Health Professional Date:01/24/00ISR Number: 3446611-1Report Type:Expedited (15-DaCompany Report #EWC000105410 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Hepatic Enzyme Increased Health Imipramine C Hepatotoxicity Professional Jaundice Overdose Date:01/24/00ISR Number: 3446613-5Report Type:Expedited (15-DaCompany Report #EWC000105396 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 480 MG/DAY Intentional Misuse Health Xanax C Professional Company Representative Date:01/24/00ISR Number: 3446614-7Report Type:Expedited (15-DaCompany Report #GBT000100210 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Condition Aggravated Study Modecate C Feeling Abnormal Health Aspirin C Hallucination, Auditory Professional Fluoxetine C Paranoia Other Psychotic Disorder Suicidal Ideation 24-Jun-2005 12:19 PM Page: 879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/00ISR Number: 3446657-3Report Type:Expedited (15-DaCompany Report #US_991233261 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Zyprexa (Olanzapine) PS 10 MG Toxicologic Test Abnormal Professional Luvox (Fluvoxamine Maleate) C Xanax (Alprazolam) C Date:01/24/00ISR Number: 3446820-1Report Type:Expedited (15-DaCompany Report #US_990826789 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Foreign Zyprexa (Olanzapine) PS 20 MG Drug Ineffective Study Hallucination Health Schizophrenia Professional Suspiciousness Other Date:01/24/00ISR Number: 3446823-7Report Type:Expedited (15-DaCompany Report #US_990927736 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa (Olanzapine) PS 20 MG Initial or Prolonged Condition Aggravated Study Valproic Acid C Delusion Health Risperidone C Drug Ineffective Professional Flunitrazepam C Hallucination Other Hostility Psychotic Disorder Schizophrenia Date:01/24/00ISR Number: 3446999-1Report Type:Expedited (15-DaCompany Report #AU_000101035 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Zyprexa (Olanzapine) PS Prolactinoma Health Professional Other Date:01/24/00ISR Number: 3447424-7Report Type:Expedited (15-DaCompany Report #HQ0551018JAN2000 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Efexor (Venlafaxine Initial or Prolonged Overdose Professional Hydrochloride) PS ORAL OVERDOSE Other Respiratory Rate Other AMOUNT Increased UNKNOWN ORAL 1 DAY Sedation Ethanol (Ethanol) SS ORAL OVERDOSE Tachycardia AMOUNT UNKNOWN ORAL 1 DAY Olanzapine (Olanzapine) SS ORAL OVERDOSE AMOUNT UNKNOWN ORAL 1 DAY 24-Jun-2005 12:19 PM Page: 880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/00ISR Number: 3448408-5Report Type:Expedited (15-DaCompany Report #HQ0585219JAN2000 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Efexor (Venlafaxine Initial or Prolonged Overdose Professional Hydrochloride) PS ORAL AMOUNT Respiratory Depression Other UNKNOWN ORAL Sedation Co-Proxamol Tachycardia (Dextropropoxyphene Hydrochloride, Paracetamol) SS ORAL "10" ONE TIME ORAL 1 DAY Lorazepam (Lorazepam) SS ORAL "4" ONE TIME ORAL 1 DAY Olanzapine (Olanzapine) SS ORAL "4" ONE TIME ORAL 1 DAY Thioridazine (Thioridazine) SS ORAL "14" ONE TIME ORAL 1 DAY Date:01/28/00ISR Number: 3447826-9Report Type:Direct Company Report # Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Miosis Zyprexa PS ORAL 10MG PO QD Tramadol Hcl SS ORAL 50MG PO Q8H PRN Arisept C Quinidine C Vicodin C Keflex C Risperdal C Osteomyelitis C Kcl C Lasix C Reg Insulin C Ditropan C Date:01/28/00ISR Number: 3448091-9Report Type:Expedited (15-DaCompany Report #210415 Age:17 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased Disability Blood Urea Increased Chest Pain Delusion Delusional Disorder, Persecutory Type Fatigue Hallucination, Auditory Increased Appetite Medication Error Paraesthesia Protein Total Increased Psychotic Disorder Schizophrenia Sedation 24-Jun-2005 12:19 PM Page: 881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Cellcept Health (Mycophenolate Professional Mofetil) 250 Mg PS ORAL 1000 MG 2 PER DAY ORAL Deltasone (Prednisone) SS ORAL 10 MG DAILY ORAL Fk506 (Tacrolimus) SS ORAL 2 MG 1 PER DAY ORAL Zyprexa (Olanzapine) SS PARAVENOUS Prednisone (Prednisone) SS ORAL ORAL Prograf (Tacrolimus) C Atenolol (Atenolol) C Procardia (Nifedipine) C Moduretic (Amiloride Hydochloride/Hydroch lorothiazide) C Unicap (Ascorbic Acid/Cholecalciferol /Folic Acid/Vitamin A/Vitamin B Complex/Vitamin E) C Folic Acid (Folic Acid) C Septra Ds (Sulfamethoxazole/Tr imethoprim) C Dht (Dihydrotachysterol) C Zoloft (Sertraline Hydrochloride) C Sk-65 (Propoxyphene Hydrochloride) C Amiloride (Amiloride Hydrochloride) C Hydrochlorothiazide (Hydrochlorothiazide ) C Benzotropine (Benztropine Mesylate) C Haloperidol (Haloperidol) C Nifedipine Xl (Nifedipine) C Dihydrotachysterol (Dihydrotachysterol) C Co-Trimoxazole (Sulfamethoxazole/Tr imethoprim) C 24-Jun-2005 12:19 PM Page: 882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3447879-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Rolling Zyprexa 5 Mg Tab PS ORAL 5MG PO HS Depakote 500mg SS 500MG 9AM , 1000MG HS Tegretol C Date:01/31/00ISR Number: 3448574-1Report Type:Expedited (15-DaCompany Report #US98020553A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Zyprexa (Olanzapine) PS 15 MG / 1 DAY Initial or Prolonged Neutropenia Professional Bethanechol C Benztropine (Benzatropine) C Risperidone C Ciprofloxacin C Date:01/31/00ISR Number: 3448579-0Report Type:Expedited (15-DaCompany Report #US_000134310 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Consumer Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Coma Lithium C Disability Dehydration Antihypertensive C Other Drug Interaction Embolism Gangrene Hyperglycaemia Leg Amputation Pain In Extremity Vomiting Weight Increased Date:01/31/00ISR Number: 3448582-0Report Type:Expedited (15-DaCompany Report #US_000134251 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Diabetic Ketoacidosis Professional Risperdal Renal Failure Company (Risperidone) C Thrombocytopenia Representative Date:01/31/00ISR Number: 3448585-6Report Type:Expedited (15-DaCompany Report #EWC000105436 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa (Olanzapine) PS 7.5 MG DAY Initial or Prolonged Health Lithium Carbonate C Professional Hexaglucon C Other 24-Jun-2005 12:19 PM Page: 883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3448588-1Report Type:Expedited (15-DaCompany Report #EWC000105476 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa (Olanzapine) PS 5 MG DAY Health Professional Company Representative Date:01/31/00ISR Number: 3448594-7Report Type:Expedited (15-DaCompany Report #EWC991205137 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Insomnia Health Anafranil Mania Professional (Clomipramine Psychotic Disorder Hydrochloride) C Serepax (Oxazepam) C Sectral (Acebutolol Hydrochloride) C Halcion (Triazolam) C Melleril (Thioridazine Hydrochloride) C Stelazine (Trifluoperazine Hydrochloride) C Date:01/31/00ISR Number: 3448596-0Report Type:Expedited (15-DaCompany Report #GBS000105252 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Foreign Zyprexa (Olanzapine) PS Epistaxis Health St John'S Wort C Nasopharyngitis Professional Thrombocythaemia Date:01/31/00ISR Number: 3448600-XReport Type:Expedited (15-DaCompany Report #DE_000101964 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Euthyrox Professional (Levothyroxine Sodium) C Jodetten (Potassium Iodine) C Atosil (Isopromethazine Hydrochloride) C Antra (Omeprazole) C 24-Jun-2005 12:19 PM Page: 884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3448605-9Report Type:Expedited (15-DaCompany Report #AU_000101070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Olanzapine PS 10 MG/DAY Hospitalization - Phosphokinase Increased Health Initial or Prolonged Bronchitis Professional Confusional State Dehydration Depression Disorientation Neuroleptic Malignant Syndrome Overdose Pneumonia Date:01/31/00ISR Number: 3448611-4Report Type:Expedited (15-DaCompany Report #EWC000105435 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Haemoglobin Decreased Health Betaserc Haemolytic Anaemia Professional (Betahistine Red Blood Cell Count Company Hydrochloride) C Decreased Representative Akineton (Biperiden Sedation Other Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Stugeron (Cinnarizine) C Date:01/31/00ISR Number: 3448616-3Report Type:Expedited (15-DaCompany Report #US_000134170 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 5 MG/DAY Neutropenia Professional Paxil (Paroxetine Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Neutrophils/18 C Neutrophils/45 C Neutrophils/26 C Absolute Neutrophil Count/1.0 C Absolute Neutrophil Count/0.4 C Absolute Neutrophil Count/1.6 C Absolute Neutrophil Count/0.8 C Wbc Count/4.4 C Wbc Count/2.8 C Wbc Count/2.2 C Wbc Count/3.6 C Wbc Count/3.1 C 24-Jun-2005 12:19 PM Page: 885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3448619-9Report Type:Expedited (15-DaCompany Report #GBS000105268 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Foreign Zyprexa (Olanzapine) PS 5 MG AT Increased Health BEDTIME Joint Swelling Professional Stelazine Lacrimation Increased Company (Trifluoperazine Oedema Peripheral Representative Hydrochloride) C Periorbital Oedema Other Seroxat (Paroxetine Thrombocytopenia Hydrochloride) C Lithium C Date:01/31/00ISR Number: 3448622-9Report Type:Expedited (15-DaCompany Report #EWC000105503 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vaginal Haemorrhage Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Health Fluanxol Professional (Flupentixol Company Dihydrochloride) C Representative Other Date:01/31/00ISR Number: 3448626-6Report Type:Expedited (15-DaCompany Report #US_990725058 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa Neutrophil Count Professional (Olanazapine) PS 15 MG/1 DAY Decreased Depakote (Valproate Semisodium) C Multivitamins W/Minerals C Date:01/31/00ISR Number: 3448939-8Report Type:Expedited (15-DaCompany Report #US_991233345 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa (Olanzapine) PS 10 MG/1 AT Initial or Prolonged Pancreatitis Necrotising Professional BEDTIME 2 YR Surgery Company Haldol C Representative Cogentin C Neurontin C Effexor C Insulin C Date:01/31/00ISR Number: 3448940-4Report Type:Expedited (15-DaCompany Report #US_990929044 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Health Zyprexa (Olanzapine) PS 10 MG/1 DAY 3 MON Optic Neuritis Professional Trazodone C Tofranil C Clonazepam C 24-Jun-2005 12:19 PM Page: 886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3448942-8Report Type:Expedited (15-DaCompany Report #US_991233233 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Health Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Thromboplastin Time Professional Prolonged Blood Bilirubin Increased Chromaturia Fatigue Hepatitis B Hepatitis B Antibody Positive Hepatitis B Surface Antigen Positive Hepatomegaly Jaundice Liver Function Test Abnormal Prothrombin Time Prolonged Date:01/31/00ISR Number: 3448943-XReport Type:Expedited (15-DaCompany Report #US_991233336 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatitis C Health Zyprexa (Olanzapine) PS Hospitalization - Necrosis Professional Depakote C Initial or Prolonged Pancreatitis Company Vistaril C Representative Wellbutrin C Glucophage C Date:01/31/00ISR Number: 3448945-3Report Type:Expedited (15-DaCompany Report #GBS991205022 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa (Olanzapine) PS 20 MG/ DAY Health Droperidol C Professional Company Representative Other Date:01/31/00ISR Number: 3448946-5Report Type:Expedited (15-DaCompany Report #US98020907A Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Neutropenia Professional Risperidone C Other Benztropine C Bethanechol C Risperidone C Ciprofloxacin C 24-Jun-2005 12:19 PM Page: 887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3448948-9Report Type:Expedited (15-DaCompany Report #US_991233282 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Periorbital Haematoma Study Olanzapine PS 2 DSG FORM Initial or Prolonged Periorbital Oedema Health DAY Road Traffic Accident Professional Aricept C Date:01/31/00ISR Number: 3448949-0Report Type:Expedited (15-DaCompany Report #GBS000105153 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Date:01/31/00ISR Number: 3448952-0Report Type:Expedited (15-DaCompany Report #US_991233059 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Prozac (Fluoxetine Hospitalization - Diabetes Mellitus Professional Hydrochloride) PS 20 MG/1 DAY Initial or Prolonged Diabetic Complication Zyprexa Hyperphagia (Olanazapine) SS 10 MG/1 DAY Increased Appetite Glocphage (Metformin Insomnia Hydrochloride) C Restlessness Niddm C Urinary Incontinence Klonopin(Clonazepam) C Diabeta (Glibenclamide) C Risperdal (Risperidone) C Benadryl (Diphenhydramine Hydrochloride) C Date:01/31/00ISR Number: 3448954-4Report Type:Expedited (15-DaCompany Report #DE_000101899 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Recurrent Foreign Zyprexa (Olanzapine) PS 2 MON Initial or Prolonged Haemolytic Anaemia Health Acerbon (Lisinopril) C Metastasis Professional Thrombocytopenia White Blood Cell Count Increased Date:01/31/00ISR Number: 3448955-6Report Type:Expedited (15-DaCompany Report #EWC000105272 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Increased Health Serenase Aspartate Professional (Haloperdiol) C Aminotransferase Diapam (Diazepam) C Increased Kestine (Ebastine) C Hepatomegaly Weight Increased 24-Jun-2005 12:19 PM Page: 888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3448956-8Report Type:Expedited (15-DaCompany Report #EWC991004593 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 26 MON Initial or Prolonged Thrombocytopenia Health Akineton (Biperiden Professional Hydrochloride) C Cisordinol (Clopenthixol Hydrochloride) C Rhinocort (Budesonide) C Date:01/31/00ISR Number: 3448957-XReport Type:Expedited (15-DaCompany Report #US_990421242 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa (Olanzapine) PS 20 MG/1 DAY Nephrolithiasis Health Antihypertensive C Nightmare Professional Pain In Extremity Pruritus Genital Date:01/31/00ISR Number: 3448958-1Report Type:Expedited (15-DaCompany Report #US_000133621 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS 15 MG/DAY Professional Cogentin (Benzatropine Mesilate) C Haldol (Haloperidol) C Cannabis C Date:02/01/00ISR Number: 3448815-0Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Irritability Health Olanzapine 10mg Tab PS 20MG HS Initial or Prolonged Overdose Professional Xanax SS UNKNOWN Sedation Darvocet SS Albuterol Inhaler C Beclovent C Atrovent C Paroxetine C Clonazepam C Theophylline C Propanolol C Dibucaine Ointment C Date:02/01/00ISR Number: 3450186-0Report Type:Expedited (15-DaCompany Report #HQ0726126JAN2000 Age:30 YR Gender:Male I/FU:I Outcome PT Hospitalization - Akathisia Initial or Prolonged Bradykinesia Other Chills Masked Facies 24-Jun-2005 12:19 PM Page: 889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinsonism Report Source Product Role Manufacturer Route Dose Duration Health Temesta Tablet Professional (Lorazepam) PS ORAL ORAL Zyprexa (Olanzapine) SS 15 45 DAY Lithiofor C Clopixol C Date:02/02/00ISR Number: 3449891-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Impairment Zyprexa PS ORAL 5MG PO * 1 Initial or Prolonged Muscle Spasms DOSE Other Tremor Date:02/02/00ISR Number: 3450969-7Report Type:Expedited (15-DaCompany Report #HQ8458114DEC1999 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Tachycardia Health Ativan Tablet PS ORAL 0.5 MG 2 X Initial or Prolonged Drug Effect Decreased Professional PER 1 DAY, Other Psychotic Disorder ORAL Respiratory Rate Lanoxin SS ORAL 1 MG 1 X PER Decreased 1 DAY, ORAL Temazepam SS ORAL ORAL Verapamil SS ORAL 0.5 MG 2 X PER 1 DAY, ORAL Zyprexa SS ORAL 10 MG 1 X PER 1 DAY , ORAL Zyprexa SS ORAL 20 MG 1 X PER 1 DAY , ORAL Date:02/04/00ISR Number: 3452655-6Report Type:Expedited (15-DaCompany Report #A002866 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Zoloft Tablets PS ORAL 50.00 MG Initial or Prolonged Health TOTAL:DAILY:O Required Professional RAL Intervention to Other Olanzapine SS Prevent Permanent Alcohol SS ORAL ORAL Impairment/Damage Date:02/07/00ISR Number: 3453982-9Report Type:Expedited (15-DaCompany Report #EWC000105436 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa (Olanzapine) PS 7.5 MG DAY Initial or Prolonged Health Lithium Carbonate C Professional (Glibneclamide) C Other 24-Jun-2005 12:19 PM Page: 890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/00ISR Number: 3454029-0Report Type:Expedited (15-DaCompany Report #EWC991004593 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Foreign Zyprexa (Olanzapine) PS 10 MG/ DAY 2 YR Initial or Prolonged Deficit/Hyperactivity Health Akineton C ORAL 6MG Disorder Professional Cisordinol C ORAL Benign Prostatic Other Rhinocort Hyperplasia (Budesonide) C ORAL Body Temperature Decreased Haematuria Haemorrhage Renal Cyst Thrombocytopenia Urethral Disorder Weight Decreased Date:02/07/00ISR Number: 3454034-4Report Type:Expedited (15-DaCompany Report #EWC991205083 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa (Olanzapine) PS 310 MG / DAY Initial or Prolonged Delirium Health Aropax C ORAL 40MG/DAY Disorientation Professional Extrapyramidal Disorder Other Hypertonia Intentional Misuse Movement Disorder Sedation Suicide Attempt Date:02/07/00ISR Number: 3454039-3Report Type:Expedited (15-DaCompany Report #US_991131668 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa (Olanzapine) PS 25 MG/ 1 DAY Therapeutic Professional Haldol (Haloperidol) C ORAL Valproate Sodium C Hydroxyzine C Temazepam C 30MG/1 DAY Date:02/07/00ISR Number: 3454043-5Report Type:Expedited (15-DaCompany Report #EWC000105274 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Zyprexa (Olanzapine) PS 5 MG/ DAY Blood Creatine Health Effexor C 150MG/DAY Phosphokinase Increased Professional Mepronizine C Hepatitis Other Tranxene C 50MG/DAY Liver Function Test Abnormal Nausea 24-Jun-2005 12:19 PM Page: 891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/00ISR Number: 3454046-0Report Type:Expedited (15-DaCompany Report #EWC000105396 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 15 MG/ DAY Health Xanax C ORAL Professional Date:02/07/00ISR Number: 3454058-7Report Type:Expedited (15-DaCompany Report #EWC981001726 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa (Olanzapine) PS Hospitalization - Blood Bicarbonate Health Clomipramine C Initial or Prolonged Decreased Professional Thyrax Blood Creatinine Other (Levothyroxine) C Increased Propranolol C Cyanosis Lithium C Dyspnoea Electrocardiogram Qrs Complex Prolonged Hepatic Function Abnormal Hepatosplenomegaly Hyperkalaemia Hypoglycaemia Hyponatraemia Hypotension Malaise Metabolic Acidosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Oxygen Saturation Decreased Respiratory Failure Tachycardia Date:02/07/00ISR Number: 3454063-0Report Type:Expedited (15-DaCompany Report #GBS000105252 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Foreign Zyprexa (Olanzapine) PS Epistaxis Health St. John'S Wort C Kaolin Cephalin Clotting Professional Time Prolonged Other Nasopharyngitis Date:02/07/00ISR Number: 3454066-6Report Type:Expedited (15-DaCompany Report #US_000134170 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Zyprexa (Olanzapine) PS 5 MG/DAY Decreased Professional Paxil (Paroxetine White Blood Cell Count Hydrochloride) C Decreased Zantac (Ranitidine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/00ISR Number: 3454229-XReport Type:Expedited (15-DaCompany Report #GBS000105289 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Syndrome Health Droperidol C Professional Lorazepam C ORAL 8MG/DAY Other Procyclidine C Sulpiride C Beechams Powders Nf C Date:02/07/00ISR Number: 3454231-8Report Type:Expedited (15-DaCompany Report #GBS000105300 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Phosphokinase Increased Health Carbamazepine C Myocardial Infarction Professional Urispas (Flavoxate Other Hydrochloride) C 600MG/DAY Date:02/07/00ISR Number: 3454233-1Report Type:Expedited (15-DaCompany Report #US_000134594 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Professional Valproic Acid C Date:02/07/00ISR Number: 3454235-5Report Type:Expedited (15-DaCompany Report #EWC000105538 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Tercian Professional (Cyamemazine) C ORAL Other Date:02/07/00ISR Number: 3454237-9Report Type:Expedited (15-DaCompany Report #EWC000105532 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Zyprexa (Olanzapine) PS Bundle Branch Block Health Prazinil Cardiac Arrest Professional (Carpipramine Cardio-Respiratory Arrest Other Dihydrochloride) C Circulatory Collapse Athymil(Mianserin Coma Hydrochloride) C Convulsion Lexomil (Bromazepam) C Malaise Date:02/07/00ISR Number: 3454244-6Report Type:Expedited (15-DaCompany Report #EWC000105540 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/00ISR Number: 3454248-3Report Type:Expedited (15-DaCompany Report #EWC000105539 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Zyprexa (Olanzapine) PS 10 MG DAY Sudden Death Health Antihypertensive Professional Drugs C Other Benzodiazepine C Hyperium (Rilmenidine) C Buspar (Buspirone Hydrochloride) C Diamicron (Gliclazide) C Lipanthyl (Fenofibrate) C Nitriderm Tts (Glyceryl Trinitrate) C Vastarel (Trimetazidine Dihydrochloride) C Aspirine (Acetylsalicylic Acid) C Date:02/07/00ISR Number: 3454249-5Report Type:Expedited (15-DaCompany Report #DE_000101977 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Intentional Misuse Health Amitriptyline C Loss Of Consciousness Professional Tavor (Lorazepam) C Other Akineton (Biperiden Hydrochloride) C Metoprolol C Date:02/07/00ISR Number: 3454251-3Report Type:Expedited (15-DaCompany Report #US_000133468 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Health Zyprexa (Olanzapine) PS YR Aminotransferase Professional Valproic Acid C Increased Doxycycline C Blood Creatine Phosphokinase Increased Drug Interaction Pyrexia Thermal Burn Toxic Epidermal Necrolysis Date:02/07/00ISR Number: 3455018-2Report Type:Expedited (15-DaCompany Report #EWC000105506 Age:35 YR Gender:Female I/FU:I Outcome PT Hospitalization - Electrocardiogram Qrs Initial or Prolonged Complex Prolonged Electrocardiogram Qt 24-Jun-2005 12:19 PM Page: 894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 20 MG Health Nozinan Professional (Levomepromazine) C Other Mepronizine C Seresta (Oxazepam) C Date:02/07/00ISR Number: 3455019-4Report Type:Expedited (15-DaCompany Report #EWC000105528 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Zyprexa (Olanzapine) PS 10 MG DAY 2 MON Distress Syndrome Health Solian (Amisulpride) C Cardio-Respiratory Arrest Professional Seropram (Citalopram Mydriasis Other Hydrobromide) C Date:02/07/00ISR Number: 3455020-0Report Type:Expedited (15-DaCompany Report #DE_000101985 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Health Professional Other Date:02/07/00ISR Number: 3455022-4Report Type:Expedited (15-DaCompany Report #CA_000101113 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Neutrophil Count Health Stelazine Decreased Professional (Trifluoperazine Platelet Count Decreased Company Hydrochloride) C White Blood Cell Count Representative Decreased Other Date:02/07/00ISR Number: 3455035-2Report Type:Expedited (15-DaCompany Report #DE_000101967 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Myelodysplastic Syndrome Health Zoloft (Sertraline Thrombocytopenia Professional Hydrochloride) C Other Date:02/07/00ISR Number: 3455038-8Report Type:Expedited (15-DaCompany Report #US_000134612 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Pneumonia Professional Gabapentin C Isordil (Isosorbide Dinitrate) C Prevacid 24-Jun-2005 12:19 PM Page: 895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lansoprazole) C Lopressor (Metoprolol Tartrate) C Date:02/07/00ISR Number: 3455040-6Report Type:Expedited (15-DaCompany Report #DE_000101984 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY 2 YR Nasal Congestion Health Professional Other Date:02/07/00ISR Number: 3455041-8Report Type:Expedited (15-DaCompany Report #DE_000101976 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Professional Other Date:02/09/00ISR Number: 3455195-3Report Type:Periodic Company Report #8-99075-020A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Norplant System PS SUBCUTANEOUS SUBCUTANEOUS Amenorrhoea Navane SS 40 G 1X PER 1 Anxiety DAY Asthenia Zyprexa SS 20 MG 1X PER Condition Aggravated 1 DAY Depression Navane (Thiothixene) C Muscle Spasms Zyprexa (Olanzapine) C Muscle Twitching Elavil Photosensitivity Reaction (Amitriptyline Hcl) C Weight Increased Cogentin (Benztropine Mesylate ) C Klonopin (Clonazepam) C Date:02/09/00ISR Number: 3455515-XReport Type:Expedited (15-DaCompany Report #A0104288A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Lamictal Initial or Prolonged Drug Interaction Professional (Formulation Leukopenia Unknown) Neutropenia (Lamotrigine) PS ORAL 100MG / ORAL Suicidal Ideation Valproic Acid (Formulation Unknown) (Valproic Acid) SS ORAL 750 MG / AT NIGHT / ORAL Olanzapine (Formulation Uknown ) (Olanzapine) SS ORAL 5 MG / AT 24-Jun-2005 12:19 PM Page: 896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report NIGHT / ORAL Bupropion Hydrochloride C Clonazepam C Date:02/10/00ISR Number: 3456221-8Report Type:Expedited (15-DaCompany Report #20000100512 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Computerised Tomogram Foreign Plendil PS ORAL 20 MG QD PO Abnormal Health Valproate Sodium SS Dyspnoea Professional Atenolol SS Dyspnoea Exertional Olanzapine SS Forced Expiratory Volume Lithium Carbonate C Abnormal Lung Disorder Pulmonary Fibrosis Pulmonary Function Test Abnormal Date:02/10/00ISR Number: 3619661-XReport Type:Periodic Company Report #US_000235962 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:02/11/00ISR Number: 3456770-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Citalopram (Celexa) Initial or Prolonged Complications Of Maternal 40mg Exposure To Therapeutic Forest/Parke-Davis PS Forest /Park-Davis ORAL 40MG PO QD Drugs Olanzapine (Zyprexa) Convulsion Neonatal 10 Mg Lilly SS Lilly ORAL 10MG PO QD Feeling Jittery Gentamicin C Hypotonia Butorphanol C Hypoventilation Neonatal Ampicillin C Neonatal Apnoeic Attack Opisthotonus Premature Baby Date:02/14/00ISR Number: 3457402-XReport Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa 15 Mg/Day PS 15MG/DAY Muscle Rigidity Professional Lithobid 600 Mg Bid SS 600 MG BID Pyrexia Neurontil 600mg Tid SS 600MG TID Tremor Symmetrel 900mg/Day SS 900MG/DAY 24-Jun-2005 12:19 PM Page: 897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3457512-7Report Type:Expedited (15-DaCompany Report #US_991029811 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Excoriation Health Zyprexa (Olanzapine) PS Haemorrhage Professional Mirtazapine C Overdose Pulmonary Oedema Toxicologic Test Abnormal Date:02/14/00ISR Number: 3457513-9Report Type:Expedited (15-DaCompany Report #US_000134310 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa (Olanzapine) PS 10 MG 1 DAY Initial or Prolonged Cardiovascular Disorder Health Lithium C Disability Coma Professional Antihypertensive C Other Dehydration Embolism Gangrene Hyperglycaemia Neuroleptic Malignant Syndrome Pain In Extremity Pyrexia Renal Impairment Vomiting Weight Increased Date:02/14/00ISR Number: 3457514-0Report Type:Expedited (15-DaCompany Report #US_000134594 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa (Olanzapine) PS 20 MG/1 DAY White Blood Cell Count Professional Valproic Acid C Decreased Date:02/14/00ISR Number: 3457515-2Report Type:Expedited (15-DaCompany Report #EWC991104896 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Congestion Foreign Zyprexa (Olanzapine) PS Health Modecate Professional (Fluphenazine Other Decanoate) C Valium (Diazepam) C Rohypnol (Flunitrazepam) C Tegretol (Carbamazepine) C Date:02/14/00ISR Number: 3457516-4Report Type:Expedited (15-DaCompany Report #EWC991004497 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Death Death Foreign Health Professional 24-Jun-2005 12:19 PM Page: 898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG DAY Orap (Pimozide) C Date:02/14/00ISR Number: 3457517-6Report Type:Expedited (15-DaCompany Report #GBS991104823 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa (Olanzapine) PS 20 MG DAY Drug Level Above Health Zopiclone C Therapeutic Professional Fentazin Hyporeflexia Other (Perphenazine) C Injury Asphyxiation Date:02/14/00ISR Number: 3457518-8Report Type:Expedited (15-DaCompany Report #GBS000105300 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 15 MG DAY Initial or Prolonged Phosphokinase Increased Health Carbamazepine C Myocardial Infarction Professional Urispas (Flavoxate Other Hydrochloride) C Date:02/14/00ISR Number: 3457519-XReport Type:Expedited (15-DaCompany Report #EWC981001726 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa (Olanzapine) PS Hospitalization - Blood Bicarbonate Health Clomipramine C Initial or Prolonged Decreased Professional Thyrax Blood Creatinine Other (Levothyroxine) C Increased Propranolol C Blood Ph Decreased Lithium C Cyanosis Dyspnoea Electrolyte Imbalance Hyperkalaemia Hyponatraemia Hypotension Malaise Metabolic Acidosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Respiratory Failure Date:02/14/00ISR Number: 3457520-6Report Type:Expedited (15-DaCompany Report #EWC990804093 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Cyanosis Health Benzodiazepine C Professional Other 24-Jun-2005 12:19 PM Page: 899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3457521-8Report Type:Expedited (15-DaCompany Report #EWC991004496 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa (Olanzapine) PS 20 MG Malaise Health Moduretic C Pallor Professional Amlor (Amlodipine Pyrexia Company Besilate) C Representative Lepticur (Tropatepine Hydrochloride) C Imovane (Zopiclone) C Effexor (Venlafaxine Hydrochloride) C Terican (Cyamemazine) C Date:02/14/00ISR Number: 3457522-XReport Type:Expedited (15-DaCompany Report #DE_991201884 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphopenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Weight Increased Health Pipamperone C Professional Date:02/14/00ISR Number: 3457523-1Report Type:Expedited (15-DaCompany Report #EWC000105435 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Haemoglobin Decreased Health Betaserc(Betahistine Haemolytic Anaemia Professional Hydrochloride) C Red Blood Cell Count Company Akineton(Biperiden Decreased Representative Hydrochloride) C Sedation Zantac(Ranitidine Hydrochloride) C Stugeron(Cinnarizine ) C Date:02/14/00ISR Number: 3457524-3Report Type:Expedited (15-DaCompany Report #EWC000105528 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Zyprexa (Olanzapine) PS 10 MG DAY 2 MON Distress Syndrome Health Amisulpride C Bronchospasm Professional Citalopram C Cardio-Respiratory Arrest Other Anafranil Coma (Clomipramine Pneumonia Hydrochloride) C Self-Medication Propranolol C Date:02/14/00ISR Number: 3457525-5Report Type:Expedited (15-DaCompany Report #DE_000101964 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Hypersensitivity Health Euthyrox Overdose Professional (Levothyroxine 24-Jun-2005 12:19 PM Page: 900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Jodetten(Potassium Iodide) C Atosil(Isopromethazi ne Hydrochloride) C Antra (Omeprazole) C Date:02/14/00ISR Number: 3457661-3Report Type:Expedited (15-DaCompany Report #US_000235333 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa (Olanzapine) PS Exposure To Therapeutic Professional Zoloft (Sertraline Drugs Company Hydrochloride) C Dystonia Representative Tardive Dyskinesia Date:02/14/00ISR Number: 3457662-5Report Type:Expedited (15-DaCompany Report #US_990927627 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Change Health Zyprexa (Olanzapine) PS Supraventricular Professional Zoloft (Sertraline Tachycardia Company Hydrochloride) C Representative Date:02/14/00ISR Number: 3457663-7Report Type:Expedited (15-DaCompany Report #US_000235119 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Zyprexa (Olanzapine) PS Professional Risperdal (Risperidone) C Date:02/14/00ISR Number: 3457664-9Report Type:Expedited (15-DaCompany Report #US_000235005 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Date:02/14/00ISR Number: 3457665-0Report Type:Expedited (15-DaCompany Report #US_000235009 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Restlessness Health Professional Other 24-Jun-2005 12:19 PM Page: 901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3457800-4Report Type:Expedited (15-DaCompany Report #US_000234999 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Platelet Count Decreased Health Chlorpromazine C Suicidal Ideation Professional Haloperidol C Promethazine C Date:02/14/00ISR Number: 3457801-6Report Type:Expedited (15-DaCompany Report #US_000235246 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa (Olanzapine) PS Professional Date:02/14/00ISR Number: 3457804-1Report Type:Expedited (15-DaCompany Report #US_000235241 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematocrit Decreased Health Zyprexa (Olanzapine) PS 10 MG/1 AT Haemoglobin Decreased Professional BEDTIME 2 MON Mean Cell Haemoglobin Prozac (Fluoxetine Decreased Hydrochloride) SS 20 MG/2 DAY 5 YR Mean Cell Volume Abnormal Red Blood Cell Count Decreased Date:02/14/00ISR Number: 3457811-9Report Type:Expedited (15-DaCompany Report #EWC000205592 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Movement Disorder Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Fatigue Health Risperdal Muscle Contractions Professional (Risperidone) C Involuntary Other Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Pyrexia Vomiting Date:02/14/00ISR Number: 3457814-4Report Type:Expedited (15-DaCompany Report #EWC000105534 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atelectasis Foreign Zyprexa (Olanzapine) PS Hospitalization - Cardio-Respiratory Arrest Health Tercian Initial or Prolonged Coma Professional (Cyamemazine) C Intentional Misuse Other Rohypnol Pneumonia (Flunitrazepam) C Suicide Attempt 24-Jun-2005 12:19 PM Page: 902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3457817-XReport Type:Expedited (15-DaCompany Report #EWC000205600 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Cardiac Disorder Health Serenase Electrocardiogram Professional (Haloperidol) C Abnormal Other Truxal Ventricular Hypertrophy (Chlorprothixene Hydrochloride) C Diskipal (Orphenadrine Hydrochloride) C Date:02/14/00ISR Number: 3457819-3Report Type:Expedited (15-DaCompany Report #EWC000205643 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Induced Foreign Zyprexa (Olanzapine) PS Complications Of Maternal Health Ixel C Exposure To Therapeutic Professional Unspecified Drugs Company Anxiolytic C Congenital Cardiovascular Representative Oral Contraceptive Anomaly Other Nos C Pregnancy Date:02/14/00ISR Number: 3457821-1Report Type:Expedited (15-DaCompany Report #GBS000205346 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Haemorrhage Foreign Zyprexa (Olanzapine) PS 25 MG/DAY Initial or Prolonged Health Professional Other Date:02/14/00ISR Number: 3457824-7Report Type:Expedited (15-DaCompany Report #GBS000205361 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Zyprexa (Olanzapine) PS Exposure To Therapeutic Health Drugs Professional Placental Disorder Other Pregnancy Small For Dates Baby Stillbirth Date:02/14/00ISR Number: 3457826-0Report Type:Expedited (15-DaCompany Report #GBS000205354 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Exposure To Extreme Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Temperature Health Reboxetine C Hypothermia Professional Clonazepam C Overdose Company Representative Other 24-Jun-2005 12:19 PM Page: 903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3457831-4Report Type:Expedited (15-DaCompany Report #US_000235253 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Zyprexa (Olanzapine) PS Initial or Prolonged Electrocardiogram Professional Abnormal Fatigue Date:02/14/00ISR Number: 3457833-8Report Type:Expedited (15-DaCompany Report #DE_991101736 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Lymphopenia Health Tavor (Lorazepam) C Weight Increased Professional Date:02/14/00ISR Number: 3457835-1Report Type:Expedited (15-DaCompany Report #US_000235033 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Aricept (Donepezil Other Blood Creatinine Company Hydrochloride) C Increased Representative Blood Urea Increased Confusional State Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Renal Failure Date:02/14/00ISR Number: 3457837-5Report Type:Expedited (15-DaCompany Report #DE_000202018 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Health Leponex (Clozapine) C Professional Other Date:02/14/00ISR Number: 3457838-7Report Type:Expedited (15-DaCompany Report #DE_000202021 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vaginal Haemorrhage Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Other Date:02/14/00ISR Number: 3457839-9Report Type:Expedited (15-DaCompany Report #US_000234984 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Platelet Count Decreased Foreign Health 24-Jun-2005 12:19 PM Page: 904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG/DAY Date:02/14/00ISR Number: 3457841-7Report Type:Expedited (15-DaCompany Report #US_000234979 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Other Date:02/14/00ISR Number: 3457853-3Report Type:Expedited (15-DaCompany Report #CH98030121A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Life-Threatening Diabetes Mellitus Study Haloperidol SS Hospitalization - Diarrhoea Health Chloraldurat Initial or Prolonged Electrolyte Imbalance Professional (Chloral Hydrate) C Gastrointestinal Lorazepam C Infection Pipamperone C Polydipsia Oxazepam C Vomiting Antra C Water Intoxication Date:02/14/00ISR Number: 3457863-6Report Type:Expedited (15-DaCompany Report #EWC000105550 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Foreign Olanzapine PS 10 MG/ 1 AT Initial or Prolonged Pyrexia Health BEDTIME White Blood Cell Count Professional Nozinan Increased Other (Levomepromazine) C Flunitrazepam C Lithionit (Lithium Sulfate) C Date:02/14/00ISR Number: 3457864-8Report Type:Expedited (15-DaCompany Report #EWC000105564 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Olanzapine PS 15 MG/DAY Initial or Prolonged Pulmonary Embolism Health Professional Other Date:02/14/00ISR Number: 3459611-2Report Type:Periodic Company Report #001-0945-990106 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Drug Level Above Therapeutic 24-Jun-2005 12:19 PM Page: 905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Drunk Nausea Report Source Product Role Manufacturer Route Dose Duration Consumer Neurontin (Gabapentin) PS ORAL PER ORAL Lithobid (Lithium Carbonate) SS ORAL 600 MG (DAILY), PER ORAL Zyprexa (Olanzapine) SS ORAL PER ORAL Wellbutrin (Amfebutamone Hydrochloride) SS ORAL PER ORAL Ambien (Zolpidem Tartrate) SS ORAL PER ORAL Zoloft (Sertraline Hydrochloride) SS ORAL PER ORAL Klonopin (Clonazepam) SS ORAL PER ORAL Benzotropine (Benzatropine Mesilate) SS ORAL PER ORAL Inderal (Propranolol Hydrochloride) C Date:02/15/00ISR Number: 3458387-2Report Type:Expedited (15-DaCompany Report #A0105387A Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Lamictal Initial or Prolonged Drug Interaction Professional (Formulation Heart Rate Decreased Company Unknown) Hypotension Representative (Lamotrigine) PS ORAL 200 MG / TWICE PER DAY / ORAL Olanzapine (Olanzapine) SS 5 MG / PER DAY Risperidone C Lithium Salt C Venlafaxine Hydrochloride C Sinemet C Date:02/16/00ISR Number: 3458850-4Report Type:Expedited (15-DaCompany Report #2000SIN0008 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Sinemet Initial or Prolonged Dementia Health (Carbidopa/Levodopa) PS ORAL 1200 MG DLY Drug Interaction Professional PO Other Ni (Olanzapine) SS ORAL 2.5 MG DLY PO 24-Jun-2005 12:19 PM Page: 906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/00ISR Number: 3460262-4Report Type:Periodic Company Report #8-98106-004A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Furuncle Health Effexor PS ORAL 75 MG 2X PER Oedema Professional 1 DAY, ORAL Oedema Peripheral Zyprexa SS Pain Zyprexa (Olanzapine) C Date:02/22/00ISR Number: 3460545-8Report Type:Expedited (15-DaCompany Report #A004598 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zoloft Tablets PS ORAL 100.00 MG Circulatory Collapse Health TOTAL: ORAL Weight Increased Professional Olanzapine SS ORAL 20.00 MG Company TOTAL: DAILY: Representative ORAL Procyclidine SS ORAL 5.00 MG TOTAL: DAILY: ORAL Date:02/22/00ISR Number: 3460691-9Report Type:Expedited (15-DaCompany Report #EWC991205047 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Hospitalization - Eczema Health Etumine C Initial or Prolonged Professional Temesta C Nozinan C Date:02/22/00ISR Number: 3460694-4Report Type:Expedited (15-DaCompany Report #US_991131624 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 10 MG/ 1 AT Professional BEDTIME Risperdal C Serzone C Depakote C Date:02/22/00ISR Number: 3460876-1Report Type:Expedited (15-DaCompany Report #EWC000105436 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa (Olanzapine) PS 7.5 MG DAY Initial or Prolonged Health Lithium Carbonate C Professional Hexaglucon Other (Glibenclamide) C Date:02/22/00ISR Number: 3460878-5Report Type:Expedited (15-DaCompany Report #EWC000205592 Age:62 YR Gender:Male I/FU:F Outcome PT Hospitalization - Coma Initial or Prolonged Eye Movement Disorder Fatigue 24-Jun-2005 12:19 PM Page: 907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Contractions Involuntary Musculoskeletal Stiffness Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Syndrome Health Risperdal Pneumonia Professional (Risperidone) C Pyrexia Other Vomiting Date:02/22/00ISR Number: 3460880-3Report Type:Expedited (15-DaCompany Report #EWC000105528 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Zyprexa (Olanzapine) PS 10 MG DAY 2 MON Distress Syndrome Health Solian (Amisulpride) C Asthma Professional Seropram (Citalopram Bronchospasm Other Hydrobromide) C Cardio-Respiratory Arrest Anafranil Coma (Clomipramine Mydriasis Hydrochloride) C Pneumonia Avlocardyl (Propranolol) C Date:02/22/00ISR Number: 3460883-9Report Type:Expedited (15-DaCompany Report #GBS990904304 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa (Olanzapine) PS Exposure To Therapeutic Health Drugs Professional Talipes Date:02/22/00ISR Number: 3461077-3Report Type:Expedited (15-DaCompany Report #AU_000201147 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Zyprexa (Olanzapine) PS White Blood Cell Count Health Decreased Professional Other Date:02/22/00ISR Number: 3461078-5Report Type:Expedited (15-DaCompany Report #AU_000201131 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Foreign Olanzapine PS 10 MG/DAY Increased Consumer Other Date:02/22/00ISR Number: 3461081-5Report Type:Expedited (15-DaCompany Report #CA_000201159 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Other Hepatosplenomegaly Foreign Leukopenia Health Neutropenia Professional 24-Jun-2005 12:19 PM Page: 908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 20 MG/DAY Methotrimeprazine C Trimipramine C Biperiden C Clonazepam C Amoxapine C Misoprostol C Naproxen C Methylphenidate C Acetaminophen C Fenofibrate C Date:02/22/00ISR Number: 3461101-8Report Type:Expedited (15-DaCompany Report #US_991131623 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa (Olanzapine) PS 10 MG/1 AT Initial or Prolonged Confusional State Professional BEDTIME Decreased Appetite Lithium C Diarrhoea Drug Toxicity Fatigue Leukocytosis Oliguria Renal Failure Acute Thrombocythaemia Vomiting Date:02/22/00ISR Number: 3461137-7Report Type:Expedited (15-DaCompany Report #US_ 991131619 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa (Olanzapine Other Cardio-Respiratory Arrest Professional ) PS 20 MG/ 1 AT Convulsion BEDTIME Depakote (Valproate Semisodium) C Clozaril C Date:02/22/00ISR Number: 3461140-7Report Type:Expedited (15-DaCompany Report #US_991030278 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine Initial or Prolonged Hyperglycaemia Professional ) PS 20 MG/1 DAY Albuterol C Prilosec (Omeprazole) C Cogentin (Benzatropine Mesilate) C Haldol (Haloperidol) C Klonopin C 24-Jun-2005 12:19 PM Page: 909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/00ISR Number: 3461145-6Report Type:Expedited (15-DaCompany Report #US_991232959 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aortic Thrombosis Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Hospitalization - Blood Creatine Professional Lithium C Initial or Prolonged Phosphokinase Increased Valproic Acid C Disability Blood Creatinine Vasotec (Enalapril Other Increased Maleate) C Blood Ketone Body Clonazepam C Increased Niaspan (Nocotinic Coagulopathy Acid) C Diabetic Hyperosmolar Indocin Coma (Indometacin) C Drug Level Above Therapeutic Drug Toxicity Foot Amputation Gangrene Hyperglycaemia Hypertension Leukocytosis Muscle Rigidity Nephrogenic Diabetes Insipidus Neuralgia Neuroleptic Malignant Syndrome Peripheral Ischaemia Peripheral Vascular Disorder Postoperative Infection Pseudomonas Infection Pyrexia Tachycardia Tachypnoea Date:02/22/00ISR Number: 3461197-3Report Type:Expedited (15-DaCompany Report #GBS000205435 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Zyprexa (Olanzapine) PS 20 MG/DAY Professional Other Date:02/22/00ISR Number: 3461199-7Report Type:Expedited (15-DaCompany Report #DE_000202032 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Differential White Blood Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Cell Count Abnormal Health Neurocil Influenza Like Illness Professional (Levomepromazine Leukopenia Other Maleate) C 24-Jun-2005 12:19 PM Page: 910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/00ISR Number: 3461821-5Report Type:Expedited (15-DaCompany Report #US_000235129 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa (Olanzapine) PS 20 MG/DAY 1 WK Initial or Prolonged Agitation Literature Clonazepam C Delusion Health Haloperidol C Insomnia Professional Levopromazin C Irritability Other Flurazepam C Mania Pressure Of Speech Psychomotor Hyperactivity Date:02/22/00ISR Number: 3461826-4Report Type:Expedited (15-DaCompany Report #DE_000202026 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Carbamazepine C Professional Faustan (Diazepam) C Other Date:02/23/00ISR Number: 3461667-8Report Type:Expedited (15-DaCompany Report #EWC000205697 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Dermatitis Health Professional Company Representative Other Date:02/23/00ISR Number: 3461668-XReport Type:Expedited (15-DaCompany Report #DE_000202011 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Professional Other Date:02/23/00ISR Number: 3461669-1Report Type:Expedited (15-DaCompany Report #DE_000202002 Age:76 YR Gender:Female I/FU:I Outcome PT Life-Threatening Anisocytosis Hospitalization - Bronchopulmonary Initial or Prolonged Aspergillosis Diarrhoea Leukocytosis Leukopenia Lymphopenia Neutrophil Toxic Granulation Present Neutrophilia Platelet Disorder Pneumonia 24-Jun-2005 12:19 PM Page: 911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Poikilocytosis Sepsis Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS Health Professional Other Date:02/23/00ISR Number: 3461670-8Report Type:Expedited (15-DaCompany Report #US_000235519 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Depression Professional Lithium C Joint Stiffness Company Zoloft (Sertraline Muscle Rigidity Representative Hydrochloride) C Neuroleptic Malignant Klonopine Syndrome (Clonazepam) C Restlessness Cogentin (Benzatropine Mesilate) C Date:02/23/00ISR Number: 3461671-XReport Type:Expedited (15-DaCompany Report #US_000235316 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Professional Paxil (Paroxetine Hydrochloride) C Date:02/23/00ISR Number: 3461672-1Report Type:Expedited (15-DaCompany Report #EWC000205707 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Sudden Death Health Leponex (Clozapine) C Professional Depral (Sulpiride) C Company Representative Other Date:02/23/00ISR Number: 3461673-3Report Type:Expedited (15-DaCompany Report #US_980808397 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 5 MG/QHS AT Initial or Prolonged Cardiac Failure Health BEDTIME Congestive Professional Captopril C Condition Aggravated Docusate C Dyspnoea Ferrous Gluconate C Fluid Retention Gemfibrozil C Nausea Hexavitamin C Polyuria Isosorbide Dinitrate C Lansoprazole C Lovastatin C Metolazone C Potassium Chloride C 24-Jun-2005 12:19 PM Page: 912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Terazosin C Vitamin E C Acetaminophen C Clonazepam C Aluminium Magnesium Silicate C Magnesium Hydroxide C Promethazine C Albuterol C Ipratropium C Furosemide C Cyanocobalamin C Warfarin C Date:02/23/00ISR Number: 3461674-5Report Type:Expedited (15-DaCompany Report #US_991232916 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Study Zyprexa (Olanzapine Life-Threatening Diarrhoea Health ) PS 10 MG /1 DAY Hospitalization - Dyspnoea Professional Iron C Initial or Prolonged Faecal Incontinence Theo-Dur Faeces Hard (Theophylline) C Fatigue Cogentin Gastrointestinal Disorder (Benzatropine Hypotension Mesilate) C Ill-Defined Disorder Prozac (Fluoxetine Intestinal Perforation Hydrochloride) C Loss Of Consciousness Ipratropium C Muscle Spasms Ibuprofen C Nausea Flovent (Fluticasone Peripheral Coldness Propionate) C Pulmonary Embolism Menthol/Lubriderm Pulse Absent Cream C Pulse Pressure Decreased Hydrocortisone C Respiratory Arrest Sepsis Vomiting Date:02/23/00ISR Number: 3463289-1Report Type:Periodic Company Report #9925404 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abscess Consumer Zoloft Tablets PS Ear Disorder Zyprexa SS Ear Pain Date:02/23/00ISR Number: 3463332-XReport Type:Periodic Company Report #9925405 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Consumer Zoloft Tablets PS Zyprexa SS 24-Jun-2005 12:19 PM Page: 913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3463711-0Report Type:Periodic Company Report #JRFUSA1999003418 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Date:02/23/00ISR Number: 3463772-9Report Type:Periodic Company Report #JRFUSA1999002494 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Risperdal (1 Mg Blood Ethanol Increased Professional Tablet) Cardio-Respiratory Arrest (Risperidone) PS ORAL 1 MG, 2 IN 1 Circulatory Collapse DAY(S), ORAL Sudden Death Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, ORAL Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Zocor (Simvastatin) C Altace (Ramipril) C Aspirin (Acetylsalicylic Acid) C Colace (Docusate Sodium) C Date:02/23/00ISR Number: 3466903-XReport Type:Periodic Company Report #JAUSA36133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Condition Aggravated Professional (Risperidone) PS ORAL ORAL Suicide Attempt Zyprexa (Olanzapine) SS ORAL ORAL Lithium (Lithium) SS ORAL ORAL Prozac (Fluoxetine) C Date:02/23/00ISR Number: 3467128-4Report Type:Periodic Company Report #JRFUSA1999000490 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL Zyprexa (Olanzapine) SS ORAL 10 MG, 2 IN 1 DAY(S), ORAL Paxil (Paroxetine Hydrochloride) C Date:02/23/00ISR Number: 3467263-0Report Type:Periodic Company Report #9952625 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zoloft Tablets PS Professional Prozac SS 24-Jun-2005 12:19 PM Page: 914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa SS Date:02/23/00ISR Number: 3468471-5Report Type:Periodic Company Report #9947688 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Consumer Zoloft Tablets PS 50.00 MG TOTAL:DAILY Olanzapine SS 20.00 MG TOTAL:DAILY Trazadone SS 100.00 MG TOTAL:DAILY Date:02/23/00ISR Number: 3469884-8Report Type:Periodic Company Report #9940913 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tooth Disorder Health Zoloft Tablets PS 100.00 MG Professional TOTA: DAILY Olanzapine SS Depakote SS Date:02/24/00ISR Number: 3462127-0Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Zyprexa 5 Mg Lilly PS 5 MG Q DAY Syndrome SEVERAL WEEKS Depakote C Synthroid C Midazolam C Date:02/24/00ISR Number: 3463194-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Zyprexa SS Date:02/24/00ISR Number: 3463328-8Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Zyprexa 10mg. Lilly PS Lilly ORAL 10 MG H.S. Intervention to Cataract Operation ORAL Prevent Permanent Lens Implant Impairment/Damage Date:02/24/00ISR Number: 3467571-3Report Type:Periodic Company Report #US_990725568 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 10 MG /1 DAY Initial or Prolonged Syndrome Professional Prozac (Fluoxetine Hydrochloride) SS 10 MG/ 1 DAY 24-Jun-2005 12:19 PM Page: 915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Ativan (Lorazepam) C Date:02/24/00ISR Number: 3467678-0Report Type:Periodic Company Report #US_990927684 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Fluoxetine Initial or Prolonged Health (Fluoxetine Professional Hydrochloride) PS 20 MG/ 1 DAY Olanzapine SS 10 MG/ 1 DAY Glucophage (Metformin Hydrochloride) C Glucotrol (Glipizide) C Cardizem Cd (Diltiazem Hydrochloride) C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Date:02/24/00ISR Number: 3467685-8Report Type:Periodic Company Report #US_990928350 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 20 MG Initial or Prolonged Psychotic Disorder Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 80 MG Date:02/24/00ISR Number: 3467739-6Report Type:Periodic Company Report #US_980503657 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 20 MG/DAY Olanzapine SS 15 MG/AT BEDTIME Motrin (Ibuprofen) C Date:02/24/00ISR Number: 3467741-4Report Type:Periodic Company Report #US_980504135 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Depakote (Valproate Semisodium) C Sudafed (Pseudoephedrine Hydrochloride) C Bc Powder C Genora C 24-Jun-2005 12:19 PM Page: 916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vicks Formula C Testosterone Propionate C Prozac (Fluoxetine Hydrochloride) C Multivitamin C Date:02/24/00ISR Number: 3468486-7Report Type:Periodic Company Report #US_991131132 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa (Olanzapine) PS 15 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 20 MG DAY Date:02/24/00ISR Number: 3468569-1Report Type:Periodic Company Report #US_991233327 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Health (Fluoxetine Professional Hydrochloride) PS 40 MG/1 IN THE MORNING Olanzapine SS 10 MG/1DAY Date:02/24/00ISR Number: 3468591-5Report Type:Periodic Company Report #US_981012012 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/QPM IN Initial or Prolonged Diabetes Mellitus Health THE EVENING Gastritis Professional Prozac (Fluoxetine Gastrointestinal Disorder Hydrochloride) SS 40MG/QAM IN Lung Disorder THE MORNING Humulin Nph C Humulin Regular C Aleve C Rezulin C Prilosec C Date:02/24/00ISR Number: 3468639-8Report Type:Periodic Company Report #US_981214128 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Prozac (Fluoxetine Hydrochloride) SS 20 MG/1 IN THE MORNING Ativan C Lotensin C Naprosyn C Cimetidine C 24-Jun-2005 12:19 PM Page: 917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/00ISR Number: 3468694-5Report Type:Periodic Company Report #US_990217371 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 15 MG/1 IN Initial or Prolonged Dizziness Health THE EVENING Injury Professional Fluoxetine Paraesthesia (Fluoxetine Thinking Abnormal Hydrochlorid) SS 60 MG/1 IN THE MORNING Albuterol C Ativan C Date:02/24/00ISR Number: 3468910-XReport Type:Periodic Company Report #US_990319249 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Hallucination Health (Fluoxetine Professional Hydrochloride) PS 1 DSG FORM/ 1 IN THE MORNING Olanzapine SS 3 DSG FORM/1 IN THE EVENING Date:02/24/00ISR Number: 3469692-8Report Type:Periodic Company Report #US_990522540 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Prozac (Fluoxetine Initial or Prolonged Diabetes Mellitus Professional Hydrochloride) PS 20 MG/1 DAY Dyspnoea Zyprexa (Olanzapine) SS 7.5 MG/1 DAY Hyperglycaemia Depakote (Valproate Hypotension Semisodium) C Stomatitis Weight Decreased Date:02/24/00ISR Number: 3469714-4Report Type:Periodic Company Report #US_990623593 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Study Olanzapine PS 5 MG/1 DAY Hospitalization - Suicide Attempt Health Fluoxetine Initial or Prolonged Professional (Fluoxetine Hydrochloride) SS 60 MG/1 DAY Date:02/28/00ISR Number: 3464427-7Report Type:Expedited (15-DaCompany Report #GBS991104823 Age:18 YR Gender:Male I/FU:F Outcome PT Death Asphyxia Aspiration Atherosclerosis Brain Oedema Bronchopneumonia Coronary Artery Disease Drug Level Above 24-Jun-2005 12:19 PM Page: 918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Gastritis Hepatic Congestion Obstructive Airways Report Source Product Role Manufacturer Route Dose Duration Disorder Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Pulmonary Congestion Health Zopiclone C Pulmonary Oedema Professional Fentazin Vomiting Other (Perphenazine) C Date:02/28/00ISR Number: 3464428-9Report Type:Expedited (15-DaCompany Report #DE_000202026 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Carbamazepine C Professional Faustan (Diazepam) C Other Date:02/28/00ISR Number: 3464429-0Report Type:Expedited (15-DaCompany Report #GBS990603461 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar Disorder Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Leukopenia Health Lithium C Lymphopenia Professional Monocyte Count Decreased Other Neutropenia Platelet Count Decreased Sedation White Blood Cell Count Decreased Date:02/28/00ISR Number: 3464446-0Report Type:Expedited (15-DaCompany Report #AU_000201152 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Olanzapine PS Haemoglobin Decreased Health White Blood Cell Count Professional Decreased Other Date:02/28/00ISR Number: 3464448-4Report Type:Expedited (15-DaCompany Report #CA_000201189 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Foreign Zyprexa (Olanzapine) PS 25 MG Health Professional Other Date:02/28/00ISR Number: 3464453-8Report Type:Expedited (15-DaCompany Report #EWC000205725 Age:30 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Hepatic Enzyme Increased 24-Jun-2005 12:19 PM Page: 919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myalgia Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 7.5 MG DAY Health Professional Other Date:02/28/00ISR Number: 3464499-XReport Type:Expedited (15-DaCompany Report #DE_000202080 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Noctamid Professional (Lormetazepam) C Other Ferrum (Ferrous Fumarate) C Date:02/28/00ISR Number: 3464501-5Report Type:Expedited (15-DaCompany Report #US_000235704 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Prozac (Fluoxetine Pain In Extremity Hydrochloride) PS 30 MG/1 IN Pulmonary Embolism THE MORNING Zyprexa (Olanzapine) SS Ativan (Lorazepam) C Seroquel C Risperdal (Risperidone) C Oral Contraceptive Nos C Date:02/28/00ISR Number: 3464504-0Report Type:Expedited (15-DaCompany Report #US_990115579 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Olanzapine PS 5 MG/QHS AT Initial or Prolonged Aggression Health BEDTIME Cognitive Disorder Professional Acetaminophen C Confusional State Ranitidine C Drug Effect Decreased Trazodone C Haematemesis Multivitamins C Folic Acid C Date:02/28/00ISR Number: 3464505-2Report Type:Expedited (15-DaCompany Report #US_000235822 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa (Olanzapine) PS Decreased Professional 24-Jun-2005 12:19 PM Page: 920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/00ISR Number: 3464508-8Report Type:Expedited (15-DaCompany Report #US_000235816 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional Risperdal (Risperidone) C Date:02/28/00ISR Number: 3464513-1Report Type:Expedited (15-DaCompany Report #US_000235863 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Consumer Zyprexa (Olanzapine) PS 5 MG DAY Heparin C Date:02/28/00ISR Number: 3464636-7Report Type:Expedited (15-DaCompany Report #DE_000202011 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Leponex (Clozapine) C Professional Other Date:02/28/00ISR Number: 3464638-0Report Type:Expedited (15-DaCompany Report #DE_00202002 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anisocytosis Foreign Zyprexa (Olanzapine) PS Hospitalization - Diarrhoea Health Initial or Prolonged Differential White Blood Professional Cell Count Abnormal Other Leukocytosis Leukopenia Lymphopenia Neutrophil Toxic Granulation Present Platelet Disorder Pneumonia Poikilocytosis Sepsis Date:02/28/00ISR Number: 3464646-XReport Type:Expedited (15-DaCompany Report #GBS000205361 Age:1 DY Gender:Female I/FU:F Outcome PT Death Abortion Missed Arteritis Complications Of Maternal Exposure To Therapeutic Drugs Foetal Growth Retardation Foetal Movements Decreased Infarction Placental Disorder Pregnancy Premature Labour 24-Jun-2005 12:19 PM Page: 921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Small For Dates Baby Stillbirth Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS Health Professional Other Date:02/28/00ISR Number: 3464647-1Report Type:Expedited (15-DaCompany Report #GBS000205354 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Overdose Health Reboxetine C Professional Clonazepam C Company Representative Other Date:02/28/00ISR Number: 3464848-2Report Type:Expedited (15-DaCompany Report #US_000235033 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Imbalance Professional Aricept (Donepezil Other Blood Creatine Company Hydrochloride) C Phosphokinase Increased Representative Blood Creatinine Increased Blood Urea Increased Confusional State Dialysis Dysphagia Hyperhidrosis Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Renal Failure Salivary Hypersecretion Tachycardia Urinary Incontinence White Blood Cell Count Increased Date:02/28/00ISR Number: 3464849-4Report Type:Expedited (15-DaCompany Report #US_000133468 Age:16 YR Gender:Male I/FU:F Outcome PT Other Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Burning Sensation C-Reactive Protein Increased Dermatitis Bullous 24-Jun-2005 12:19 PM Page: 922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Pyrexia Toxic Epidermal Report Source Product Role Manufacturer Route Dose Duration Necrolysis Health Zyprexa (Olanzapine) PS 1 MON Professional Valproic Acid C Vibramycin (Doxycycline Hyclate) C Date:02/28/00ISR Number: 3464850-0Report Type:Expedited (15-DaCompany Report #US_991233336 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatitis C Health Zyprexa (Olanzapine) PS Hospitalization - Pancreatitis Professional Depakote (Valproate Initial or Prolonged Pancreatitis Necrotising Company Semisodium) C Representative Vistaril (Hydroxyzine Hydrochloride) C Wellbutrin Sr (Amfabeutamone Hyrdrochloride) C Glucophage (Metformin Hydrochloride) C Date:02/28/00ISR Number: 3464851-2Report Type:Expedited (15-DaCompany Report #US_991030278 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Professional Albuterol C Prilosec (Omeprazole) C Cogentin (Benzatropine Mesilate) C Haldol (Haloperidol) C Klonopin (Clonazepam) C Date:02/28/00ISR Number: 3464852-4Report Type:Expedited (15-DaCompany Report #DE_000101984 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY 2 YR Nasal Congestion Health Professional Date:02/28/00ISR Number: 3464853-6Report Type:Expedited (15-DaCompany Report #DE_000202021 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vaginal Haemorrhage Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional 24-Jun-2005 12:19 PM Page: 923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/00ISR Number: 3464945-1Report Type:Expedited (15-DaCompany Report #US_000134244 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional Depakote (Valproate Company Semisodium) C Representative Date:02/28/00ISR Number: 3464946-3Report Type:Expedited (15-DaCompany Report #EWC000205759 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Zyprexa (Olanzapine) PS 10 MG/ DAY 3 YR Sepsis Health Professional Company Representative Other Date:02/28/00ISR Number: 3464947-5Report Type:Expedited (15-DaCompany Report #EWC000205746 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa (Olanzapine) PS 10 MG/ DAY Initial or Prolonged Dizziness Health Leponex (Clozapine) C Dysphemia Professional Xanax (Alprazolam) C Spinal Osteoarthritis Other Tremor Date:02/28/00ISR Number: 3464950-5Report Type:Expedited (15-DaCompany Report #AU_000201147 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa (Olanzapine) PS Health Professional Other Date:02/28/00ISR Number: 3464952-9Report Type:Expedited (15-DaCompany Report #US_000235715 Age:9 YR Gender:Female I/FU:I Outcome PT Blister Diarrhoea Ecchymosis Enuresis Feeling Jittery Hypertrophy Breast Increased Appetite Nausea Palpitations Pyrexia Salivary Hypersecretion Sedation Thirst Urinary Tract Infection Vomiting 24-Jun-2005 12:19 PM Page: 924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa (Olanzapine) PS 7.5 MG/DAY Prozac (Fluoxetine Hydrochloride) SS Date:02/28/00ISR Number: 3464954-2Report Type:Expedited (15-DaCompany Report #GBS000205443 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG Platelet Count Decreased Health Orphenadrine C Professional Zimovane (Zopiclone) C Other Date:02/29/00ISR Number: 3466492-XReport Type:Direct Company Report # Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Depakene 250 Mg / 5 Impulsive Behaviour Ml PS ORAL 250 / 2 50/50 TID ORAL Olanzapine SS 2.5 Mg ORAL 2.5 MG QHS ORAL Date:03/01/00ISR Number: 3467557-9Report Type:Direct Company Report # Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Above Valproic Acid 250mg PS ORAL 750MG TID Therapeutic ORAL Drug Level Below Olanzapine 5mg SS ORAL 5GM TID ORAL Therapeutic Tenex C Medication Error Neutropenia Date:03/02/00ISR Number: 3469467-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000000871 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Zyprexa (Olanzapine) SS Benzatropine Mesilate SS Date:03/02/00ISR Number: 3470613-2Report Type:Expedited (15-DaCompany Report #DE_000202101 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Truxal Professional (Chlorprothixene 24-Jun-2005 12:19 PM Page: 925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Tavor (Lorazepam) C Diazepam C Date:03/03/00ISR Number: 3467732-3Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amnesia Consumer Zyprexa, Olanzapine PS 5MG TO 20MG Life-Threatening Communication Disorder Disability Confusional State Disorientation Speech Disorder Date:03/03/00ISR Number: 3467768-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Zyprexa (Olanzapine) PS 15 MG H.S. Disability Klonopin SS KLONOPIN= 1MG BID Date:03/03/00ISR Number: 3474685-0Report Type:Expedited (15-DaCompany Report #US_000336713 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Syndrome Professional Prozac (Fluoxetine Company Hydrochloride) SS 20 MG/1 DAY Representative Cogentin (Benzatropine Mesilate) C Date:03/06/00ISR Number: 3470531-XReport Type:Expedited (15-DaCompany Report #DE_000202068 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Foreign Zyprexa (Olanzapine) PS 15 MG /DAY Initial or Prolonged Pruritus Health Tavor (Lorazepam) C Rash Papular Professional Euglucon Other (Glibenclamide)C C Truxal (Chlorprothixene Hydrochloride) C Date:03/06/00ISR Number: 3470532-1Report Type:Expedited (15-DaCompany Report #US_000236051 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Zyprexa (Olanzapine) PS Initial or Prolonged Intentional Misuse Professional 24-Jun-2005 12:19 PM Page: 926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3470533-3Report Type:Expedited (15-DaCompany Report #EWC000205829 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Blood Amylase Increased Health Imovane (Zopiclone) C Diarrhoea Professional Lepticur Hepatitis Other (Tropatepine Liver Function Test Hydrochloride) C Abnormal Nozinan (Levomepromazine) C Theralene (Alimemazine Tartrate) C Haldol(Haloperidol) C Date:03/06/00ISR Number: 3470539-4Report Type:Expedited (15-DaCompany Report #US_000236390 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa (Olanzapine) PS 20 MG /1 DAY Initial or Prolonged Diabetic Coma Professional Remeron Company (Mirtazapine) C Representative Trazodone C Tegretol(Carbamazepi ne) C Luvox (Fluvoxamine Maleate) C Date:03/06/00ISR Number: 3470598-9Report Type:Expedited (15-DaCompany Report #GBS991104884 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa (Olanzapine) PS 10 MG DAY Iron Binding Capacity Health Lithium C Total Increased Professional Benzotropine Iron Deficiency Anaemia (Benzatropine Microcytic Anaemia Mesilate) C Thrombocythaemia Zuclopenthixol C Date:03/06/00ISR Number: 3470603-XReport Type:Expedited (15-DaCompany Report #US_000236334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Disorder Health Zyprexa (Olanzapine) PS Professional Date:03/06/00ISR Number: 3470606-5Report Type:Expedited (15-DaCompany Report #GBS000205481 Age:50 YR Gender:Male I/FU:I Outcome PT Agranulocytosis Akathisia Condition Aggravated Lower Respiratory Tract Infection Neutrophil Count Decreased 24-Jun-2005 12:19 PM Page: 927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 25 MG/DAY Health Professional Company Representative Date:03/06/00ISR Number: 3470609-0Report Type:Expedited (15-DaCompany Report #DE_000202064 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Professional Delix (Ramipril) C Lorzaar (Losartan Potassium) C Ebrantil (Urapidil) C Dilzem (Diltiazem Hydrochloride) C Ass C Thiamazole C Date:03/06/00ISR Number: 3470611-9Report Type:Expedited (15-DaCompany Report #DE_000202104 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Leukopenia Health Eunerpan (Melperone Professional Hydrochloride) C Tavor (Lorazepam) C Bromhexine C Date:03/06/00ISR Number: 3470614-4Report Type:Expedited (15-DaCompany Report #EWC000205825 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 35 MG/DAY Initial or Prolonged Phosphokinase Increased Health Penicillin C Catatonia Professional Theo-Dur Muscle Rigidity (Theophylline) C Neuroleptic Malignant Syndrome Overdose Pneumonia Pyrexia Date:03/06/00ISR Number: 3470616-8Report Type:Expedited (15-DaCompany Report #EWC000205810 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa (Olanzapine) PS 20 MG DAY Bronchitis Other Cardiac Arrest Fear Of Disease 24-Jun-2005 12:19 PM Page: 928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/00ISR Number: 3470340-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Olanzapine 10 Mg Hospitalization - Acidosis Lilly PS Lilly 20MG QD Initial or Prolonged Blood Glucose Increased Divalproex C Lethargy Vomiting Date:03/07/00ISR Number: 3471614-0Report Type:Expedited (15-DaCompany Report #EWC000205901 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Olanzapine PS 10 MG/DAY Health Professional Other Date:03/08/00ISR Number: 3471187-2Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertriglyceridaemia Olanzapine 10mg PS ORAL 20MG PO QHS 12 MON Initial or Prolonged Hypoglycaemia Depakote C Polydipsia Buspar C Polyuria Date:03/08/00ISR Number: 3471188-4Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Zyprexa Or Initial or Prolonged Drug Dependence Olanzapine 2.5mg Eli Other Drug Withdrawal Syndrome Lilly PS Eli Lilly 2.5MG A DAY 16 MON Pain Ambien C Date:03/08/00ISR Number: 3472200-9Report Type:Expedited (15-DaCompany Report #EWC990804090 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cholecystitis Foreign Olanzpine PS Hospitalization - Deep Vein Thrombosis Study Apranax (Naproxen Initial or Prolonged Dysuria Health Sodium) C Hepatic Pain Professional Niflugel (Niflumic Pain Other Acid) C Prostatitis Dafalgan Pulmonary Embolism (Paracetamol) C Pyrexia Depakine Chrono C Sepsis Prozac (Fluoxetine Urinary Tract Infection Hydrochloride) C Fraxiparine (Heparin-Fraction, Calcium Salt) C 24-Jun-2005 12:19 PM Page: 929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/00ISR Number: 3472507-5Report Type:Expedited (15-DaCompany Report #US_000134594 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Lymphocyte Count Professional Valproic Acid C Increased Monocyte Count Increased White Blood Cell Count Decreased Date:03/08/00ISR Number: 3472509-9Report Type:Expedited (15-DaCompany Report #US_991029811 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Excoriation Health Zyprexa (Olanzapine) PS Haemorrhage Professional Mirtazapine C Injury Overdose Pulmonary Oedema Toxicologic Test Abnormal Date:03/08/00ISR Number: 3472516-6Report Type:Expedited (15-DaCompany Report #GBS981101976 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Ventricular Tachycardia Health Depixol (Flupentixol Professional Decanoate) C Company Paroxetine C Representative Senna C Other Oxybutynin C Date:03/08/00ISR Number: 3472518-XReport Type:Expedited (15-DaCompany Report #EWC981001726 Age:41 YR Gender:Female I/FU:F Outcome PT Death Arrhythmia Hospitalization - Blood Bicarbonate Initial or Prolonged Decreased Blood Creatinine Increased Cyanosis Dyspnoea Electrocardiogram Qrs Complex Prolonged Electrolyte Imbalance Hepatosplenomegaly Hyperglycaemia Hyperkalaemia Hyponatraemia Hypotension Malaise Metabolic Acidosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Oxygen Saturation 24-Jun-2005 12:19 PM Page: 930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Respiratory Failure Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS Health Clomipramine C Professional Thyrax Other (Levothyroxine) C Propranolol C Lithium C Date:03/08/00ISR Number: 3472521-XReport Type:Expedited (15-DaCompany Report #EWC000105396 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 480 MG DAY Intentional Misuse Health Xanax (Alprazolam) C Professional Other Date:03/13/00ISR Number: 3474584-4Report Type:Expedited (15-DaCompany Report #DE_991101765 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Health Professional Other Date:03/13/00ISR Number: 3474585-6Report Type:Expedited (15-DaCompany Report #DE_000202104 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Rash Generalised Health Eunerpan (Melperone Professional Hydrochloride) C Other Tavor (Lorazepam) C Bromhexine ( C Furosemid (Furosemide) C Date:03/13/00ISR Number: 3474588-1Report Type:Expedited (15-DaCompany Report #EWC000205600 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Electrocardiogram Health Serenase Abnormal Professional (Haloperidol) C Tachycardia Truxal (Chlorprothixene Hydrochloride) C Disipal (Orphenadrine Hydrochloride) C Rivatril (Clonazepam) C 24-Jun-2005 12:19 PM Page: 931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/00ISR Number: 3474609-6Report Type:Expedited (15-DaCompany Report #EWC990202785 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Life-Threatening Blood Creatinine Health Clomipramine C Hospitalization - Increased Professional Lithium Carbonate C Initial or Prolonged Blood Urea Increased Other Tegretol Cardiac Arrest (Carbamazepine) C Hepatosplenomegaly Hyperglycaemia Hyperkalaemia Hypotension Metabolic Acidosis Muscle Rigidity Myalgia Nephritis Interstitial Neuroleptic Malignant Syndrome Oxygen Saturation Decreased Renal Impairment Respiratory Failure Sedation Date:03/13/00ISR Number: 3474610-2Report Type:Expedited (15-DaCompany Report #GBS000205443 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Foreign Zyprexa (Olanzapine) PS 10 MG Leukopenia Health Orphenadrine C Thrombocytopenia Professional Zimovane (Zopiclone) C Other Date:03/13/00ISR Number: 3474612-6Report Type:Expedited (15-DaCompany Report #US_991233035 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Zyprexa (Olanzapine) PS 10 MG 3 DAY Initial or Prolonged Phosphatase Increased Professional Depakote (Valproate Other Blood Creatinine Semisodium) C Increased Klonopin Blood Urea Increased (Clonazepam) C Diabetes Mellitus Vitamin B C Diabetic Hyperglycaemic Demadex (Torasemide) C Coma Hyzaar C Diabetic Ketoacidosis Lipitor Overdose (Atorvastatin) C Pancreatitis Acute Theophylline C Psychotic Disorder Hytrin (Terazosin Weight Decreased Hydrochloride) C Axid (Nizatidine) C Albuterol C Neurontin (Gabapentin) C Asa (Acetylsalicylic Acid) C Glucotrol (Glipizide) C 24-Jun-2005 12:19 PM Page: 932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/00ISR Number: 3474687-4Report Type:Expedited (15-DaCompany Report #US_000236596 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Zyprexa (Olanzapine) PS Convulsion Date:03/13/00ISR Number: 3474688-6Report Type:Expedited (15-DaCompany Report #US_000236591 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa (Olanzapine) PS 22.5 MG/DAY Professional Prozac (Fluoxetine Company Hydrochloride) SS 20 MG/DAY Representative Depakote (Valproate Semisodium) C Pamelor (Nortriptyline Hydrochloride) C Buspar (Buspirone Hydrochloride) C Haldol (Haloperidol) C Mellaril (Thioradazine Hydrochloride) C Allergy Shot C Date:03/13/00ISR Number: 3474693-XReport Type:Expedited (15-DaCompany Report #US_991131370 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Study Olanzapine PS 5 MG IN THE Hospitalization - Cerebrovascular Accident Health MORNING Initial or Prolonged Condition Aggravated Professional Olanzapine SS 15 MG IN THE Decreased Activity EVENING Disorientation Ativan (Lorazepam) C Drug Toxicity Synthroid Intentional Misuse (Levothyroxine Schizophrenia Sodium) C Sluggishness Lithium C Speech Disorder Prozac (Fluoxetine Suicide Attempt Hydrochloride) C Valium (Diazepam) C Date:03/13/00ISR Number: 3474695-3Report Type:Expedited (15-DaCompany Report #DE_000302124 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Truxal Professional (Chlorprothixene Other Hydrochloride) C Dalmadorm (Flurazepam Hydrochloride) C Fluanxol (Flupentixol Dihydrochloride) C 24-Jun-2005 12:19 PM Page: 933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/00ISR Number: 3474723-5Report Type:Expedited (15-DaCompany Report #GBS981202235 Age:47 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Fall Health Depixol (Flupentixol Ventricular Tachycardia Professional Decanoate) C Other Paroxetine C Senna C Oxybutynin C Date:03/13/00ISR Number: 3475099-XReport Type:Expedited (15-DaCompany Report #EWC000305906 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Foreign Olanzapine PS 5 MG/DAY Haemorrhage Health Haldol (Haloperidol) C Panic Attack Professional Nozinan Sudden Death Company (Levomepromazine) C Representative Sulfarlem (Anethole Other Trithione) C Date:03/13/00ISR Number: 3475101-5Report Type:Expedited (15-DaCompany Report #GBS000205507 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa (Olanzapine) PS Chest Pain Health Circulatory Collapse Professional Cough Company Eosinophil Count Representative Increased Other Malaise Pleural Effusion Pulmonary Haemorrhage Sudden Death Vomiting Date:03/13/00ISR Number: 3475102-7Report Type:Expedited (15-DaCompany Report #US_000235232 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Diabetic Ketoacidosis Professional Depakote (Valproate Other Hyperglycaemia Semisodium) C Nausea Polydipsia Polyuria Date:03/14/00ISR Number: 3475468-8Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Zyprexa 2.5mg PS ORAL 2T PO QHS Initial or Prolonged Coma Depressed Level Of Consciousness Disorientation 24-Jun-2005 12:19 PM Page: 934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/00ISR Number: 3476319-8Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Olanzapine PS Date:03/16/00ISR Number: 3476327-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Zyprexa PS Initial or Prolonged Professional Date:03/16/00ISR Number: 3476945-6Report Type:Expedited (15-DaCompany Report #9716243 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zoloft Tablets PS ORAL 50.00 MG Initial or Prolonged Dystonia Health TOTAL:DAILY:O Required Eye Movement Disorder Professional RAL Intervention to Eye Pain Other Zyprexa SS ORAL 15.00 MG Prevent Permanent Eye Rolling TOTAL:DAILY:O Impairment/Damage Muscle Rigidity RAL Salivary Hypersecretion Tetracycline C Droperidol C Procyclidine C Lorazepam C Date:03/17/00ISR Number: 3477359-5Report Type:Expedited (15-DaCompany Report #10309649 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrasystoles Foreign Modecate Inj 25 Initial or Prolonged Health Mg/Ml (Fluphenazine Professional Decanoate) PS INTRAMUSCULAR 25 MILLIGRAM, Other 1/1 MONTH IM Zyprexa (Olanzapine) SS ORAL 30 MILLIGRAM, 1/1 DAY, ORAL Akineton (Biperiden Lactate) SS ORAL 2 MILLIGRAM, 1/1 DAY ORAL Akineton (Biperiden Lactate) SS INTRAMUSCULAR 5 MILLIGRAM, 1/1 MONTH IM Idalprem (Lorazepam) SS ORAL .5 MG, 1/1 DAY, ORAL Date:03/20/00ISR Number: 3477559-4Report Type:Expedited (15-DaCompany Report #GBS000205507 Age:27 YR Gender:Female I/FU:F Outcome PT Death Cardiomyopathy Chest Pain Circulatory Collapse Cough Drug Interaction Malaise Pleural Effusion 24-Jun-2005 12:19 PM Page: 935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Haemorrhage Sudden Death Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG Health Professional Company Representative Other Date:03/20/00ISR Number: 3477560-0Report Type:Expedited (15-DaCompany Report #GBS000205346 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Ascites Health Droperidol C Cardiac Failure Professional Procyclidine C Gastric Haemorrhage Other Gastrointestinal Haemorrhage Haemoglobin Decreased Hyperkalaemia Oedema Peripheral Date:03/20/00ISR Number: 3477561-2Report Type:Expedited (15-DaCompany Report #EWC000105564 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Olanzapine PS 15 MG/DAY Initial or Prolonged Immobile Health Pulmonary Embolism Professional Other Date:03/20/00ISR Number: 3477841-0Report Type:Expedited (15-DaCompany Report #US_000336929 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Chest Pain Professional Company Representative Date:03/20/00ISR Number: 3477844-6Report Type:Expedited (15-DaCompany Report #GBS000305573 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Overdose Health Mirtazapine C Professional Procyclidine C Company Diazepam C Representative Other 24-Jun-2005 12:19 PM Page: 936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/00ISR Number: 3477848-3Report Type:Expedited (15-DaCompany Report #EWC000306019 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Company Representative Other Date:03/20/00ISR Number: 3477851-3Report Type:Expedited (15-DaCompany Report #EWC000306015 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Injury Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Company Representative Other Date:03/20/00ISR Number: 3477879-3Report Type:Expedited (15-DaCompany Report #US_000337268 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Haemorrhage Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Date:03/20/00ISR Number: 3477882-3Report Type:Expedited (15-DaCompany Report #US_000337263 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Study Olanzapine PS 7.5 MG/1 AT Initial or Prolonged Gastrointestinal Health BEDTIME Haemorrhage Professional Prolixin Haematemesis (Fluphenazine Hydrochloride) SS 5 MG/2 DAY Symmetrel (Amantadine Hydrochloride) C Niferex (Polysaccharide-Iron Complex) C Depakote (Valproate Semisodium) C Vitamin B12 C Date:03/20/00ISR Number: 3477898-7Report Type:Expedited (15-DaCompany Report #US_000337148 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Zyprexa (Olanzapine) PS 80 MG/1 DAY Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/00ISR Number: 3477899-9Report Type:Expedited (15-DaCompany Report #US_000337134 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa (Olanzapine) PS Initial or Prolonged Imprisonment Professional Prozac (Fluoxetine Leukopenia Other Hydrochloride) SS Psychotic Disorder Clozaril (Clozapine) C Date:03/20/00ISR Number: 3477901-4Report Type:Expedited (15-DaCompany Report #US_000337090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Zyprexa (Olanzapine) PS Date:03/20/00ISR Number: 3477903-8Report Type:Expedited (15-DaCompany Report #US_000336986 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa (Olanzapine) PS Sudden Death Professional Company Representative Date:03/20/00ISR Number: 3477906-3Report Type:Expedited (15-DaCompany Report #DE-000302127 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Zyprexa (Olanzapine) PS 15 MG /DAY Initial or Prolonged Neutrophil Count Health Decreased Professional Date:03/20/00ISR Number: 3477910-5Report Type:Expedited (15-DaCompany Report #DE_000302129 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa (Olanzapine) PS 5 MG / DAY Initial or Prolonged Leukopenia Date:03/20/00ISR Number: 3477912-9Report Type:Expedited (15-DaCompany Report #DE_000302126 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa (Olanzapine) PS 2.5 MG Circulatory Collapse Health Madopar C Electrocardiogram Qt Professional Cipramil C Prolonged Hypotension Loss Of Consciousness Date:03/20/00ISR Number: 3477913-0Report Type:Expedited (15-DaCompany Report #DE_000302125 Age:35 YR Gender:Female I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Cough 24-Jun-2005 12:19 PM Page: 938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Influenza Leukopenia Report Source Product Role Manufacturer Route Dose Duration Medication Error Foreign Zyprexa (Olanzapine) PS 10 MG/ DAY Neutropenia Health Tavor C Psychotic Disorder Professional Pyrexia Rhinitis Date:03/20/00ISR Number: 3477953-1Report Type:Expedited (15-DaCompany Report #EWC000305968 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Zyprexa (Olanzapine) PS Health Effexor (Venlafaxine Professional Hydrochloride) C Other Tranxene (Clorazepate Dipotassium) C Date:03/20/00ISR Number: 3477955-5Report Type:Expedited (15-DaCompany Report #EWC000305964 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Shock Health Madopar C Professional Jumex (Selegiline) C Company Nitromint (Glyceryl Representative Trinitrate) C Other Date:03/20/00ISR Number: 3477958-0Report Type:Expedited (15-DaCompany Report #EWC000305951 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Mass Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Pain Health Xanax (Alpraxolam) C Purulence Professional Tolvon (Mianserin Purulent Discharge Company Hydrochloride) C Representative Dormicum (Midazolam Other Maleate) C Date:03/20/00ISR Number: 3477963-4Report Type:Expedited (15-DaCompany Report #DE_000302144 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Neutropenia Health Fluctin (Fluoxetine Professional Hydrochloride) SS 40 MG/DAY Other Atosil (Isopromethazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/00ISR Number: 3477966-XReport Type:Expedited (15-DaCompany Report #DE_000302137 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Multiforme Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Health Laxative Nos C Professional Other Date:03/20/00ISR Number: 3477968-3Report Type:Expedited (15-DaCompany Report #DE_000302129 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Leukopenia Health Professional Other Date:03/20/00ISR Number: 3477985-3Report Type:Expedited (15-DaCompany Report #EWC000306013 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa (Olanzapine) PS 10 MG DAY Hospitalization - Cerebral Ischaemia Health Initial or Prolonged Dizziness Professional Company Representative Date:03/20/00ISR Number: 3477988-9Report Type:Expedited (15-DaCompany Report #EWC000306011 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Syndrome Health Professional Other Date:03/20/00ISR Number: 3478342-6Report Type:Expedited (15-DaCompany Report #CA_990500494 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Zyprexa (Olanzapine) PS 20 MG/1 DAY 1 YR Lung Disorder Health Malaise Professional Pulmonary Congestion Company Sudden Death Representative Toxicologic Test Abnormal Date:03/20/00ISR Number: 3478391-8Report Type:Expedited (15-DaCompany Report #US_991131370 Age:32 YR Gender:Female I/FU:F Outcome PT Life-Threatening Anxiety Hospitalization - Asthenia Initial or Prolonged Coordination Abnormal Disorientation Dysarthria 24-Jun-2005 12:19 PM Page: 940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Misuse Sluggishness Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Suicide Attempt Study Olanzapine PS 5 MG IN THE Health MORNING Professional Olanzapine SS Ativan C Synthroid C Date:03/20/00ISR Number: 3478393-1Report Type:Expedited (15-DaCompany Report #US_991232920 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Effexor C Company Tegretol C Representative Depakote C Date:03/20/00ISR Number: 3478395-5Report Type:Expedited (15-DaCompany Report #US_990421242 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Genital Pruritus Male Consumer Zyprexa (Olanzapine) PS 25 MG/1 DAY Haematuria Health Antihypertensive C Nephrolithiasis Professional Baycol C Nightmare Pain In Extremity Date:03/21/00ISR Number: 3477243-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Olanzapine PS 5 MG AT HS 1 YR Date:03/23/00ISR Number: 3479171-XReport Type:Expedited (15-DaCompany Report #00AUS10051 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Foreign Anafranil Capsule Catatonia Health (Clomipramine Constipation Professional Hydrochloride) PS ORAL 200 MG, Neuroleptic Malignant Other DAILY, ORAL Syndrome Zyprexa (Olanzapine) SS 5 MG DAILY Pollakiuria Date:03/24/00ISR Number: 3480011-3Report Type:Expedited (15-DaCompany Report #US_000337593 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Consumer Zyprexa (Olanzapine) PS Neuroleptic Malignant Syndrome Tardive Dyskinesia 24-Jun-2005 12:19 PM Page: 941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/00ISR Number: 3479987-XReport Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Zyprexa PS NOT Initial or Prolonged Depressed Level Of DOCUMENTED Consciousness Dilantin C Eye Movement Disorder Remeron C Muscle Rigidity Seroquel C Azulfidine C K-Lyte C Xanax C Date:03/27/00ISR Number: 3480590-6Report Type:Expedited (15-DaCompany Report #US_00037618 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Cancer Recurrent Health Zyprexa (Olanzapine) PS Drug Interaction Professional 5-Fluorouracil Nausea "Biosyn"(Fluorouraci Vomiting l) C Buspar (Buspirone Hydrochloride) C Glyburide C Date:03/27/00ISR Number: 3480591-8Report Type:Expedited (15-DaCompany Report #DE_000302197 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Seroxat (Paroxetine Professional Hydrochloride0 C Other Date:03/27/00ISR Number: 3480592-XReport Type:Expedited (15-DaCompany Report #EWC000306074 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Foreign Olanzapine PS 5 MG/1 DAY Initial or Prolonged Congestive Cardiomyopathy Health Cough Professional Coxsackie Viral Infection Other Difficulty In Walking Dyspnoea Electrocardiogram Change Face Oedema Oedema Peripheral Weight Increased Date:03/27/00ISR Number: 3480744-9Report Type:Expedited (15-DaCompany Report #DEU002802 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrasystoles Foreign Akineton PS ORAL 3 MG DAILY PO Initial or Prolonged Other Olanzapine SS ORAL 30 MG DAILY PO Biperiden Lactate SS INTRAMUSCULAR 5 MG DAILY IM Fluphenazine 24-Jun-2005 12:19 PM Page: 942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decanoate SS INTRAMUSCULAR 5 MG DAILY IM Lorazepam SS ORAL 0.5 MG DAILY PO Date:03/27/00ISR Number: 3480816-9Report Type:Expedited (15-DaCompany Report #US_000337410 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ewing'S Sarcoma Health Zyprexa (Olanzapine) PS 2.5 MG/1 AT Initial or Prolonged Professional BEDTIME Acetaminophen C Date:03/27/00ISR Number: 3480882-0Report Type:Expedited (15-DaCompany Report #DE_000302137 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Exfoliative Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Erythema Multiforme Health Laxative Nos C Professional Dominal (Prothipendyl Hydrochloride) C Date:03/27/00ISR Number: 3480883-2Report Type:Expedited (15-DaCompany Report #US_000337134 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa (Olanzapine) PS Initial or Prolonged Leukopenia Professional Prozac (Fluoxetine Psychotic Disorder Other Hydrochloride) SS Clozaril (Clozapine) C Date:03/27/00ISR Number: 3480887-XReport Type:Expedited (15-DaCompany Report #GBS991104823 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Aspiration Health Zopiclone C Atherosclerosis Professional Fentazin Brain Oedema Other (Perphenazine) C Bronchopneumonia Congestive Cardiomyopathy Drug Level Above Therapeutic Gastritis Hepatic Congestion Obstructive Airways Disorder Pulmonary Congestion Pulmonary Oedema Vomiting Date:03/27/00ISR Number: 3480891-1Report Type:Expedited (15-DaCompany Report #EWC000306011 Age:20 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased 24-Jun-2005 12:19 PM Page: 943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Hypertension Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Mutism Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Neuroleptic Malignant Health Modecate Syndrome Professional (Fluphenazine Oral Intake Reduced Decanoate) C Pyrexia Haloperidol C Restlessness Lithium C Tachycardia Urinary Incontinence Date:03/27/00ISR Number: 3480897-2Report Type:Expedited (15-DaCompany Report #DE_991201879 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depression Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Pulmonary Embolism Study Saroten - Slow Initial or Prolonged Health Release Professional (Amitripyline Other Hydrochloride) C Radepur (Chlordiazepoxide) C Risperdal (Risperidone) C Nipolept (Zotepine) C Date:03/27/00ISR Number: 3480905-9Report Type:Expedited (15-DaCompany Report #EWC000306119 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa (Olanzapine) PS 10 MG DAY Health Tercian Professional (Cyamemazine) C Other Lepticur (Tropatepine Hydrochloride) C Date:03/27/00ISR Number: 3480906-0Report Type:Expedited (15-DaCompany Report #AU_000301216 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Neutropenia Health Fluoxetine C Professional Diazepam C Other Valproate Sodium C Chlorpromazine C Melleril (Thioridazine Hydrochloride) C Date:03/27/00ISR Number: 3481195-3Report Type:Expedited (15-DaCompany Report #DE_000302176 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Leukopenia Foreign Health 24-Jun-2005 12:19 PM Page: 944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG/DAY Cipramil (Citalopram) C L-Thyroxin (Levothyroxine Sodium) C Date:03/27/00ISR Number: 3481196-5Report Type:Expedited (15-DaCompany Report #EWC000306060 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa (Olanzapine) PS 35 MG Initial or Prolonged Health Alopam (Oxazepam) C Professional Akineton (Biperiden Other Hydrochloride) C Date:03/27/00ISR Number: 3481198-9Report Type:Expedited (15-DaCompany Report #DE_000202018 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Health Leponex (Clozapine) C Professional Nacom C Other Fevarin (Fluvoxamine Maleate) C Magnesium Verla Dragees C Mono Embolex (Heparin) C Antra (Omeprazole) C Ibuprofen C Date:03/27/00ISR Number: 3481199-0Report Type:Expedited (15-DaCompany Report #GBS000305589 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Albumin Increased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Blood Alkaline Health Seroquel C Phosphatase Increased Professional Leukopenia Other Polycythaemia Date:03/27/00ISR Number: 3481200-4Report Type:Expedited (15-DaCompany Report #EWC000306032 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Pancytopenia Health Tiaprizal (Tiapride Professional Hydrochloride) C Other Adiro (Acetylsalicylic Acid) C Relif (Nabumetone) C 24-Jun-2005 12:19 PM Page: 945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/00ISR Number: 3481202-8Report Type:Expedited (15-DaCompany Report #EWC000306035 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Extrasystoles Health Akineton (Biperiden Professional Hydrochloride) C Other Akineton For Injection (Biperiden Lactate) C Modecate (Fluphenazine Decanoate) C Idalprem (Lorazepam) C Date:03/29/00ISR Number: 3481378-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Olanzapine PS 20 MG AT Extrapyramidal Disorder BEDTIME 1 MON Date:03/29/00ISR Number: 3481398-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Olanzapine PS 10 MG BID Increased Hypercholesterolaemia Date:03/29/00ISR Number: 3481408-8Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Carbidopa / Levodopa PS 25/100 - 2 Initial or Prolonged Delusion TABLETS X 5 Other Hallucination DAYS; 50/200 Mental Impairment 1 HS Paranoia Olanzapine SS 2.5 MG HS Asa C Lansoprazole C Pompirone C Metoprolol C Felodipine C Paxil C Ranitidine C Isosorbid Mononitrate C Pergolide C Date:03/29/00ISR Number: 3481452-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Olanzapine 15 Mg PS 15 MG AT Increased Professional BEDTIME 24-Jun-2005 12:19 PM Page: 946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/00ISR Number: 3481468-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Olanzapine PS 2.5 MG BID >3 MONTHS Date:03/29/00ISR Number: 3481469-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Olanzapine PS 15 MG AT Decreased BEDTIME Date:03/29/00ISR Number: 3481470-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aspartate Olanzapine PS 15 MG Q AM Aminotransferase 20 MG HS Increased Hyperglycaemia Date:03/29/00ISR Number: 3481471-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine PS 15 MG QD Date:03/30/00ISR Number: 3481969-9Report Type:Expedited (15-DaCompany Report #000328-SK104 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Celebrex (Celecoxib) PS ORAL PO Depressed Level Of Other Eltroxin Consciousness (Levothyroxine Muscle Rigidity Sodium) SS ORAL PO Pyrexia Olanzapine Serotonin Syndrome (Olanzapine) SS ORAL PO Parnate (Tranylcypromine Sulfate) SS ORAL PO 30 YR Date:04/03/00ISR Number: 3482998-1Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Olanzapine PS Initial or Prolonged Hyperglycaemia Ketoacidosis Lipase Increased Renal Failure 24-Jun-2005 12:19 PM Page: 947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/00ISR Number: 3483194-4Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Olanzapine PS Initial or Prolonged Blood Creatinine Increased Blood Ph Decreased Blood Urea Increased Fatigue Hyperglycaemia Hyperkalaemia Hypernatraemia Ketonuria Malaise Pco2 Decreased Date:04/03/00ISR Number: 3483303-7Report Type:Expedited (15-DaCompany Report #CA_990500494 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Ph Decreased Foreign Zyprexa (Olanzapine) PS 20 MG/1 DAY 1 YR Dizziness Health Lung Disorder Professional Malaise Company Muscle Rigidity Representative Pulmonary Congestion Other Sudden Death Toxicologic Test Abnormal Date:04/03/00ISR Number: 3483304-9Report Type:Expedited (15-DaCompany Report #DE_000302127 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Neutropenia Health Ergenyl Chrono C Professional Other Date:04/03/00ISR Number: 3483382-7Report Type:Expedited (15-DaCompany Report #EWC000306074 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Foreign Olanzapine PS 5 MG/ 1 DAY Initial or Prolonged Congestive Cardiomyopathy Health Cough Professional Coxsackie Viral Infection Dyspnoea Face Oedema Oedema Peripheral Weight Increased Date:04/03/00ISR Number: 3483383-9Report Type:Expedited (15-DaCompany Report #DE_000302144 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Leukopenia Foreign Neutropenia Health 24-Jun-2005 12:19 PM Page: 948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG/DAY Fluctin (Fluoxetine Hydrochloride) SS 40 MG/DAY Atosil (Isophromethazine Hydrochloride) C Date:04/03/00ISR Number: 3483401-8Report Type:Expedited (15-DaCompany Report #US_000337851 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Zyprexa (Olanzapine) PS 7.5 MG/DAY 1 YR Initial or Prolonged Professional Date:04/03/00ISR Number: 3483428-6Report Type:Expedited (15-DaCompany Report #US_991131370 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Study Olanzapine PS 20 MG/DAY Hospitalization - Asthenia Health Ativan (Lorazepam) C Initial or Prolonged Bulimia Nervosa Professional Synthroid Disability Cerebrovascular Accident (Levothyroxine Confusional State Sodium) C Coordination Abnormal Lithium C Disorientation Prozac (Fluoxetine Drug Interaction Hydrochloride) C Drug Toxicity Valium (Diazepam) C Dysarthria Clonazepam C Intentional Misuse Sluggishness Speech Disorder Suicide Attempt Transient Ischaemic Attack Date:04/03/00ISR Number: 3483430-4Report Type:Expedited (15-DaCompany Report #AU_000301216 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Neutropenia Health Fluoxetine C Professional Diazepam C Valproate Sodium C Chlorpromazine C Melleril (Thioridazine Hydrochloride) C Date:04/03/00ISR Number: 3483437-7Report Type:Expedited (15-DaCompany Report #EWC000305955 Age:31 YR Gender:Female I/FU:I Outcome PT Other Injection Site Abscess Injection Site Erythema 24-Jun-2005 12:19 PM Page: 949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injection Site Induration Injection Site Inflammation Report Source Product Role Manufacturer Route Dose Duration Injection Site Oedema Foreign Olanzapine PS 160 MG/1 Injection Site Pain Study MONTH Oedema Health Temesta (Lorazepam) C Skin Irritation Professional Smear Site Unspecified Abnormal Date:04/03/00ISR Number: 3483438-9Report Type:Expedited (15-DaCompany Report #DE_000302199 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Phosphokinase Increased Literature Cardiac Disorder Health Electrocardiogram St Professional Segment Abnormal Liver Function Test Abnormal Myocardial Infarction Date:04/03/00ISR Number: 3483439-0Report Type:Expedited (15-DaCompany Report #US_000337604 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Hyperglycaemia Professional Synthroid Ketoacidosis Company (Levothyroxine Representative Sodium) C Date:04/03/00ISR Number: 3483773-4Report Type:Expedited (15-DaCompany Report #US_990421242 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa (Olanzapine) PS 25 MG/1 DAY Nephrolithiasis Health Antihypertensive C Nightmare Professional Baycol (Cerivastatin Pain In Extremity Sodium) C Paranoia Pruritus Genital Date:04/03/00ISR Number: 3483917-4Report Type:Expedited (15-DaCompany Report #US_000337022 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa (Olanzapine) PS 2.5 MG/1 AT Initial or Prolonged Pneumonia Health BEDTIME Pulmonary Oedema Professional Albuterol C Renal Failure Acute Aricept (Donepezil Hydrochloride) C Artificial Tears C Aspirin (E.C.) (Acetylsaliculic Acid) C Atrovent 24-Jun-2005 12:19 PM Page: 950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Ipratropium Bromide) C Furosemide C Lanoxin (Digoxin) C Multivitamin C Norvasc (Amlodipine Besilate) C Insulin Novolin C Phoslo (Calcium Acetate) C Prinivil (Lisinopril) C Reguloid C Trazodone C Vitamin C C Vitamin E C Zoloft (Sertraline Hydrochloride) C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Ferrous Sulfate C Colace (Docusate Sodium) C Cortisporin C Hydrocortisone C Date:04/03/00ISR Number: 3483921-6Report Type:Expedited (15-DaCompany Report #DE_000202007 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Leukopenia Health Taxilan (Perazine) C Neutropenia Professional Tavor (Lorazepam) C Other Date:04/03/00ISR Number: 3484076-4Report Type:Expedited (15-DaCompany Report #EWC000306013 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Cerebral Ischaemia Company Tercian Initial or Prolonged Condition Aggravated Representative (Cyamemazine) C Dizziness Other Xanax (Alprazolam) C Psychotic Disorder Imovane (Zopiclone) C Seglor (Dihydroergotamine Mesilate) C Date:04/06/00ISR Number: 3484615-3Report Type:Direct Company Report #USP 52941 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Pfizer Zyprexa (Olanzapine ) SS Lilly 24-Jun-2005 12:19 PM Page: 951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484787-0Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Health Zyprexa (Olanzapine) PS 10 MG QHS Initial or Prolonged Cholestasis Professional Hepatic Necrosis Hepatotoxicity Jaundice Pruritus Date:04/06/00ISR Number: 3484841-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000344 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polycythaemia Vera Study Risperdal Health (Risperidone) PS ORAL 8 MG, DAILY, Professional ORAL Haldol (Unspecified) (Haloperidol) SS ORAL 14 MG, DAILY, ORAL Olanzapine (Olanzapine) SS ORAL 17.5 MG, DAILY, ORAL Atenolol (Atenolol) C Clonazepam (Clonazepam) C Cogentin (Benzatropine Mesilate) C Atenolol (Atenolol) C Clonazepam (Clonazepam) C Cogentin (Benzatropine Mesilate) C Date:04/07/00ISR Number: 3484930-3Report Type:Direct Company Report #USP 52945 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly Zyprexa SS Lilly Date:04/10/00ISR Number: 3486470-4Report Type:Expedited (15-DaCompany Report #L00-SEW-00473-01 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Cipramil (Citalopram Drug Level Above Literature Hydrobromide) PS Therapeutic Health Stesolid (Diazepam) SS Overdose Professional Zyprexa (Olanzapine) SS Toxicologic Test Abnormal 24-Jun-2005 12:19 PM Page: 952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/00ISR Number: 3486656-9Report Type:Expedited (15-DaCompany Report #US_000338289 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ammonia Increased Health Zyprexa (Olanzapine) PS 15 MG/DAY Hepatotoxicity Professional Company Representative Date:04/11/00ISR Number: 3486660-0Report Type:Expedited (15-DaCompany Report #US_000338280 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Hepatotoxicity Professional Company Representative Date:04/11/00ISR Number: 3486668-5Report Type:Expedited (15-DaCompany Report #US_000338270 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zyprexa (Olanzapine) PS Hospitalization - Ketoacidosis Professional Initial or Prolonged Renal Failure Company Other Representative Date:04/11/00ISR Number: 3486671-5Report Type:Expedited (15-DaCompany Report #US_000338029 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusion Health Zyprexa (Olanzapine) PS 20 MG/DAY Overdose Professional Carbamazepine C Date:04/11/00ISR Number: 3486675-2Report Type:Expedited (15-DaCompany Report #US_000338205 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Aminotransferase Professional Prozac (Fluoxetine Increased Hydrochloride) SS 10 MG/1 DAY Cholelithiasis Weight Increased Date:04/11/00ISR Number: 3487088-XReport Type:Expedited (15-DaCompany Report #GBS000305573 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Mirtazapine C Professional Procyclidine C Company Diazepam C Representative Heroin C Other 24-Jun-2005 12:19 PM Page: 953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/00ISR Number: 3488236-8Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Olanzapine PS 20 MG QD Hyperglycaemia Haldol C Date:04/17/00ISR Number: 3488858-4Report Type:Expedited (15-DaCompany Report #A012014 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Loss Of Consciousness Health Zyrtec Tablets PS ORAL 10.00 MG Intervention to Medication Error Professional TOTAL; ORAL Prevent Permanent Zyprexa SS ORAL 10MG ORAL Impairment/Damage Date:04/17/00ISR Number: 3489088-2Report Type:Expedited (15-DaCompany Report #US_000438492 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Health Zyprexa (Olanzapine) PS 2.5 MG/2 DAY 2 WK Initial or Prolonged Endocarditis Professional Allopurinol C Labile Blood Pressure Pyrexia Date:04/17/00ISR Number: 3489090-0Report Type:Expedited (15-DaCompany Report #US_000438908 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adenoma Benign Consumer Zyprexa (Olanzapine) PS 5 MG/1 DAY Blood Urea Abnormal Vitamins Nos C Colitis Dehydration Depersonalisation Dermatitis Contact Gastroenteritis Malabsorption Oedema Peripheral Tardive Dyskinesia Urinary Tract Disorder Date:04/17/00ISR Number: 3489091-2Report Type:Expedited (15-DaCompany Report #US_000438693 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Consumer Zyprexa (Olanzapine) PS 30 MG/DAY 4 MON Prevacid (Lansoprazole) C Date:04/17/00ISR Number: 3489094-8Report Type:Expedited (15-DaCompany Report #US_000438528 Age:43 YR Gender:Male I/FU:I Outcome PT Other Blood Creatinine Increased Chemical Poisoning Mental Impairment 24-Jun-2005 12:19 PM Page: 954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Impairment Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Hydrochlorothiazide C Date:04/17/00ISR Number: 3489146-2Report Type:Expedited (15-DaCompany Report #US_981113199 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Consumer Zyprexa (Olanzapine) PS 5 MG/1 DAY Delusion Health Hydrochlorothiazide C Dyspnoea Professional K-Dur (Potassium Grand Mal Convulsion Chloride) C Mental Disorder Norvasc (Amlodipine Pyrexia Besilate) C Urinary Tract Infection Haldol (Haloperidol) C Vomiting Ativan (Lorazepam) C Prempro C Date:04/17/00ISR Number: 3489150-4Report Type:Expedited (15-DaCompany Report #US_000337593 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Consumer Zyprexa (Olanzapine) PS Neuroleptic Malignant Syndrome Tardive Dyskinesia Date:04/17/00ISR Number: 3489152-8Report Type:Expedited (15-DaCompany Report #US_000236596 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Consumer Zyprexa (Olanzapine) PS Date:04/17/00ISR Number: 3489160-7Report Type:Expedited (15-DaCompany Report #US_990623992 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Literature Zyprexa (Olanzapine) PS 10MG/1 DAY 2 WK Initial or Prolonged Hallucination, Auditory Health Risperidone C Leukopenia Professional Neutropenia Company Representative Date:04/17/00ISR Number: 3489163-2Report Type:Expedited (15-DaCompany Report #US_000439094 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 12 MG Initial or Prolonged Condition Aggravated Health Fluoxetine SS 50 MG Erythropenia Professional Ativan C Haematocrit Decreased Lo/ Ovral C Haemoglobin Decreased Multivitamin C Uterine Haemorrhage Calcium C Tylenol C 24-Jun-2005 12:19 PM Page: 955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ferrous Sulfate C Nasonex C Date:04/17/00ISR Number: 3489165-6Report Type:Expedited (15-DaCompany Report #EWC000406344 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Foreign Olanzapine PS 10MG /DAY Leukopenia Health Seroxat C Nasopharyngitis Professional Lorazepam C Date:04/17/00ISR Number: 3489166-8Report Type:Expedited (15-DaCompany Report #US_000439034 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ageusia Consumer Zyprexa (Olanzapine) PS Bone Pain Bursitis Chest Pain Chills Dehydration Difficulty In Walking Dizziness Dry Mouth Ear Pain Enuresis Eye Pain Face Oedema Facial Pain Flatulence Gait Disturbance Gingivitis Haemorrhage Keratoconjunctivitis Sicca Laryngitis Mouth Haemorrhage Myalgia Pain In Extremity Parkinsonian Gait Pelvic Pain Phobia Purulent Discharge Pyrexia Rheumatoid Arthritis Skin Ulcer Speech Disorder Tongue Disorder Ulcer Urinary Tract Infection Visual Acuity Reduced Date:04/17/00ISR Number: 3489167-XReport Type:Expedited (15-DaCompany Report #EWC000306254 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Circulatory Collapse Foreign Initial or Prolonged Hypotension Health 24-Jun-2005 12:19 PM Page: 956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG/DAY Zoloft (Sertraline Hydrochloride) C Date:04/17/00ISR Number: 3489168-1Report Type:Expedited (15-DaCompany Report #EWC000306256 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Hallucination Health Sinemet C Sedation Professional Seresta (Oxazepam) C Other Avlocardyl (Propranolol) C Seropram (Citalopram Hydrobromide) C Cozaar (Losartan Potassium) C Tiapridal (Tiapride) C Trivastal (Piribedil) C Kardegic (Acetylsalicylate Lysine) C Tanakan (Ginkgo Tree Leaves Extract) C Date:04/17/00ISR Number: 3489310-2Report Type:Expedited (15-DaCompany Report #US_991029164 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Toxicologic Test Abnormal Health Zyprexa (Olanzapine) PS Professional Date:04/17/00ISR Number: 3559670-2Report Type:Periodic Company Report #US_000235622 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Evista PS Eli Lilly And Co 60 MG/DAY 3 WK Hostility Zyprexa (Olanzapine) SS 5MG/DAY 1 MON Aricept (Donepezil Hydrochloride) C Florinef (Fludrocortisone Acetate) C Calcium With Vitamin D C Date:04/18/00ISR Number: 3489151-6Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Liver Function Test Health Olanzapine / 10 Mg / Abnormal Professional Lilly PS Lilly ORAL 10 MG HS ORAL Fluoxetine 20mg Lilly SS Lilly ORAL 60MG AM ORAL Date:04/18/00ISR Number: 3489715-XReport Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa PS ORAL 20 MG PO Q HS Inadequate Control Hyperglycaemia Date:04/24/00ISR Number: 3491485-6Report Type:Direct Company Report # Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Zyprexa 10mg (Lilly) PS Lilly ORAL 10 MG HS ORAL Initial or Prolonged Date:04/24/00ISR Number: 3491598-9Report Type:Expedited (15-DaCompany Report #EWC000406390 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Syndrome Health Initial or Prolonged Vomiting Professional Other Date:04/24/00ISR Number: 3491600-4Report Type:Expedited (15-DaCompany Report #EWC000406384 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Dermatitis Health Headache Professional Meningitis Company Musculoskeletal Stiffness Representative Photophobia Other Posture Abnormal Date:04/24/00ISR Number: 3491604-1Report Type:Expedited (15-DaCompany Report #EWC000406363 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Lymphopenia Health Neutrophil Count Professional Decreased Other Thrombocytopenia 24-Jun-2005 12:19 PM Page: 958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/00ISR Number: 3491725-3Report Type:Expedited (15-DaCompany Report #GBS000405747 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Red Blood Cell Health Zuclopenthixol Sedimentation Rate Professional Decanoate C Increased Other Benztropine C Lithium Carbonate C Date:04/24/00ISR Number: 3491727-7Report Type:Expedited (15-DaCompany Report #US_000439298 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Increased Professional Celexa (Citalopram Full Blood Count Abnormal Hydrobromide) C Medication Error Tegretol Rash Maculo-Papular (Carbamazepine) C Schizophrenia Date:04/24/00ISR Number: 3491770-8Report Type:Expedited (15-DaCompany Report #US_991232916 Age:53 YR Gender:Female I/FU:F Outcome PT Death Adrenal Cortex Atrophy Life-Threatening Ascites Hospitalization - Atelectasis Initial or Prolonged Circulatory Collapse Colitis Ulcerative Collapse Of Lung Coma Crohn'S Disease Cytomegalovirus Infection Diabetes Insipidus Diarrhoea Dyspnoea Enterococcal Bacteraemia Faeces Hard Fatigue Haemodialysis Hypotension Inflammatory Bowel Disease Intestinal Perforation Leukocytosis Loss Of Consciousness Lung Disorder Multi-Organ Failure Muscle Spasms Nausea Peripheral Coldness Peritonitis Pleural Effusion Pseudomonal Sepsis Pseudomonas Infection Pulse Absent Pulse Pressure Decreased Renal Failure Renal Tubular Necrosis 24-Jun-2005 12:19 PM Page: 959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Failure Sepsis Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Vomiting Study Zyprexa (Olanzapine) PS 10 MG/1 DAY Health Iron C Professional Theo-Dur (Theophylline) C Cogentin (Benzatropine Mesilate) C Prozac (Fluoxetine Hydrochloride) C Ipratropium C Ibuprofen C Flovent (Fluticasone Propionate) C Menthol/Lubriderm Cream C Hydrocortisone C Date:04/24/00ISR Number: 3491772-1Report Type:Expedited (15-DaCompany Report #US_991131370 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Study Olanzapine PS 20 MG/DAY Hospitalization - Disorientation Health Ativan (Lorazepam) C Initial or Prolonged Dysarthria Professional Synthroid Intentional Misuse (Levothyroxine Sluggishness Sodium) C Suicide Attempt Lithium C Transient Ischaemic Valium (Diazepam) C Attack Clonazepam C Benztropine C Prozac C Date:04/24/00ISR Number: 3491774-5Report Type:Expedited (15-DaCompany Report #EWC000205725 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Increased Foreign Zyprexa (Olanzapine) PS 7.5 MG DAY Initial or Prolonged Blood Creatine Health Lysanxia (Prazepam) C Other Phosphokinase Increased Professional Hepatic Enzyme Increased Other Myalgia Rhabdomyolysis Date:04/24/00ISR Number: 3491776-9Report Type:Expedited (15-DaCompany Report #US_000337851 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Zyprexa (Olazapine) PS 7.5 MG/DAY 1 YR Initial or Prolonged Metastases To Lymph Nodes Professional 24-Jun-2005 12:19 PM Page: 960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/00ISR Number: 3491778-2Report Type:Expedited (15-DaCompany Report #DE_000302144 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Neutropenia Health Fluctin (Fluoxetine Professional Hydrochloride) SS 40 MG/DAY Other Atosil (Isopromethazine Hydrochloride) C Date:04/24/00ISR Number: 3491834-9Report Type:Expedited (15-DaCompany Report #DE_000302237 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Murmur Foreign Zyprexa (Olanzapine) PS TRANSPLACENTAL 5 MG/DAY Complications Of Maternal Health Tavor (Lorazepam) C TRANSPLACENTAL Exposure To Therapeutic Professional Diazepam C TRANSPLACENTAL Drugs Other Date:04/24/00ISR Number: 3491835-0Report Type:Expedited (15-DaCompany Report #US_000439161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 40 MG/ 1 DAY Professional Company Representative Other Date:04/24/00ISR Number: 3491836-2Report Type:Expedited (15-DaCompany Report #US_991130732 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Threatened Consumer Zyprexa (Olanzapine) PS 10 MG/ 1 AT Complications Of Maternal Health BEDTIME Exposure To Therapeutic Professional Prenate 90 C Drugs Company Haldol (Haloperidol) C Foetal Malposition Representative Alprazolam C Hypertension Placenta Praevia Pregnancy Induced Hypertension Vaginal Haemorrhage Date:04/24/00ISR Number: 3491837-4Report Type:Expedited (15-DaCompany Report #DE_000402277 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Foreign Zyprexa (Olanzapine) PS 4 WK Lymphopenia Health Professional Other 24-Jun-2005 12:19 PM Page: 961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/00ISR Number: 3491970-7Report Type:Expedited (15-DaCompany Report #GBS000405766 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 70 MG Initial or Prolonged Phosphokinase Increased Health Prozac (Fluoxetine Muscle Rigidity Professional Hydrochloride) SS 660 MG Neuroleptic Malignant Other Paracetamol C Syndrome Overdose Sedation Suicidal Ideation Tremor Date:04/24/00ISR Number: 3492015-5Report Type:Expedited (15-DaCompany Report #GBS000405775 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 15 MG/ 1 DAY 200 DAY Initial or Prolonged Delusion Health Schizophrenia Professional Other Date:04/27/00ISR Number: 3493712-8Report Type:Expedited (15-DaCompany Report #A012815 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zoloft Tablets PS ORAL 150.00 MG Initial or Prolonged Diabetes Mellitus TOTAL:BID:ORA Required Non-Insulin-Dependent L Intervention to Dizziness Zyprexa SS ORAL 5.00 MG Prevent Permanent Fatigue TOTAL:DAILY:O Impairment/Damage Headache RAL Influenza Like Illness Valium C Malaise Myalgia Sedation Weight Decreased Date:04/28/00ISR Number: 3493730-XReport Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Zyrtex 10 Mg Pfizer Intervention to Decreased Activity Labs PS Pfizer Labs ORAL 1/DAY/ORAL Prevent Permanent Diabetes Mellitus Zyprexa 10 Mg Lilly SS Lilly ORAL 1/DAY/ORAL Impairment/Damage Dizziness Feeling Abnormal Malaise Medication Error Sedation Speech Disorder 24-Jun-2005 12:19 PM Page: 962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/00ISR Number: 3494384-9Report Type:Expedited (15-DaCompany Report #00P-163-0089291-00 (0) Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Depakene (Depakene) Initial or Prolonged Drug Interaction Professional (Valproic Acid) PS ORAL 750 MG, 1 IN Leukopenia Other 1 HR, PER Neutropenia ORAL Suicidal Ideation Olanzapine (Olanzapine) SS ORAL 5 MG, 1 IN 1 D, PER ORAL Lamotrigine (Lamotrigine) SS ORAL 100 MG, 1 IN 1 D, PER ORAL Amfebutamone Hydrochloride (Amfebutamone Hydrochloride) C Clonazepam (Clonazepam (Clonazepam) C Date:05/01/00ISR Number: 3494549-6Report Type:Expedited (15-DaCompany Report #US_000439659 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa (Olanzapine) PS 20MG/DAY 3 WK Differential White Blood Professional Clozapine C Cell Count Abnormal Depakote (Valproate Neutropenia Semisodium) C White Blood Cell Count Folic Acid C Decreased Detrol (Tolterodine) C Hydroxyzine C Zantac (Ranitidine Hydrochloride) C Desmopressin C Enalapril C Date:05/01/00ISR Number: 3494551-4Report Type:Expedited (15-DaCompany Report #EWC000406480 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Olanzapine PS 15 MG/DAY Increased Health Co-Trimoxazole C Aspartate Professional Aminotransferase Other Increased Leukopenia Date:05/01/00ISR Number: 3494635-0Report Type:Expedited (15-DaCompany Report #US_000439380 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disseminated Health Zyprexa (Olanzapine) PS 210 MG/DAY Hospitalization - Intravascular Coagulation Professional Cannabis C Initial or Prolonged Overdose Toxicologic Test Abnormal 24-Jun-2005 12:19 PM Page: 963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/00ISR Number: 3494637-4Report Type:Expedited (15-DaCompany Report #US_981011175 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Pregnancy Professional Zyprexa (Olanzapine) SS 25 MG/1 DAY Prozac (Fluoxetine Hydrochloride) SS 20 MG/ 1 DAY Date:05/01/00ISR Number: 3494639-8Report Type:Expedited (15-DaCompany Report #US_000440102 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa (Olanzapine) PS Syndrome Professional Depakote (Valproate Company Semisodium) C Representative Date:05/01/00ISR Number: 3494665-9Report Type:Expedited (15-DaCompany Report #EWC000406416 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged C-Reactive Protein Health Imovane (Zopiclone) C Increased Professional Sobril C Confusional State Other Antabus (Disulfiram) C Convulsion Nicotine Transdermal Drug Ineffective System (Nicotine Drug Level Above Resin) C Therapeutic Dysarthria Hyponatraemia Leukocytosis Motor Dysfunction Nausea Neutrophilia Polydipsia Urinary Tract Infection Vertigo Water Intoxication Date:05/01/00ISR Number: 3494668-4Report Type:Expedited (15-DaCompany Report #EWC000406432 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperpyrexia Foreign Zyprexa (Olanzapine) PS 450 MG/DAY Hospitalization - Inflammation Health Tavor (Lorazepam) C Initial or Prolonged Intentional Misuse Professional Lung Disorder Sinus Tachycardia Stupor Date:05/01/00ISR Number: 3494669-6Report Type:Expedited (15-DaCompany Report #EWC000406453 Age:91 YR Gender:Female I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Dementia 24-Jun-2005 12:19 PM Page: 964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Hallucination, Visual Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Health Haldol (Haloperidol) C Professional Imovane (Zopiclone) C Other Levothyrox (Levothyroxine Sodium) C Tardyferon (Ferrous Sulfate) C Timolol Maleate C Sterogyl C Tanakan (Ginkgo Tree Leaves Extract) C Date:05/01/00ISR Number: 3494671-4Report Type:Expedited (15-DaCompany Report #EWC000406489 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Olanzapine PS 20 MG Phosphokinase Increased Health Valproate Sodium C Fatigue Professional Hyperhidrosis Hypoaesthesia Joint Stiffness Neuroleptic Malignant Syndrome Date:05/01/00ISR Number: 3494673-8Report Type:Expedited (15-DaCompany Report #GBS000405785 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Lower Respiratory Tract Health Citalopram C Infection Professional Pneumonia Date:05/01/00ISR Number: 3494676-3Report Type:Expedited (15-DaCompany Report #US_000235870 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Rhabdomyolysis Health Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Professional Lanoxin (Digoxin) C Initial or Prolonged Coumadin (Warfarin Sodium) C Verapamil C Date:05/01/00ISR Number: 3494929-9Report Type:Expedited (15-DaCompany Report #GBS000405775 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 15 MG/ 1 DAY 28 WK Initial or Prolonged Delusion Health Schizophrenia Professional 24-Jun-2005 12:19 PM Page: 965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/00ISR Number: 3494959-7Report Type:Expedited (15-DaCompany Report #DE_990901568 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Zyprexa (Olanzapine) PS 20 MG/ DAY Initial or Prolonged Hypotension Health Truxal C Tachycardia Professional Other Date:05/01/00ISR Number: 3495075-0Report Type:Expedited (15-DaCompany Report #US_000337022 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa (Olanzapine) PS 2.5 MG/1 AT Initial or Prolonged Cardiac Failure Health BEDTIME Congestive Professional Albuterol C Pneumonia Aricept (Donepezil Pulmonary Oedema Hydrochloride) C Renal Failure Acute Artificial Tears C Aspirin (E.C.) (Acetylsalicylic Acid) C Atrovent (Ipratropium Bromide) C Furosemide C Lanoxin (Digoxin) C Multivitamin C Norvasc (Amlodipine Besilate) C Insulin Novolin C Phoslo (Calcium Acetate) C Prinivil (Lisinopril) C Reguloid C Trazodone C Vitamin C C Vitamin E C Zoloft (Sertraline Hydrochloride) C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Ferrous Sulfate C Colace (Docusate Sodium) C Cortisporin C Hydrocortisone C Azmacort (Triamcinolone Acetonide) C Cartia (Acetylsalicylic Acid) C Famvir (Famciclovir) C 24-Jun-2005 12:19 PM Page: 966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/00ISR Number: 3495095-6Report Type:Expedited (15-DaCompany Report #US_000439161 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 40 MG/1 DAY Professional Company Representative Date:05/01/00ISR Number: 3495097-XReport Type:Expedited (15-DaCompany Report #DE_000202101 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Biopsy Bone Marrow Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Abnormal Health Truxal Hyperplasia Professional (Chlorprothixene Platelet Disorder Other Hydrochloride) C Thrombocytopenia Tavor(Lorazepam) C Diazepam C Date:05/01/00ISR Number: 3495392-4Report Type:Expedited (15-DaCompany Report #US_000439615 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Health Zyprexa (Olanzapine) PS 15 MG / IN Initial or Prolonged Decreased Appetite Professional THE EVENINGS Feeling Cold Prozac (Fluoxetine Hyperhidrosis Hydrochloride) SS 60 MG/DAY Hypothermia Prednisone C Oedema Neurontin C Pallor Prevacid C Sedation Potassium C Weight Decreased Demadex C Quinine C Date:05/01/00ISR Number: 3495395-XReport Type:Expedited (15-DaCompany Report #DE_000402308 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Shock Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Health Furanthril C Professional Heparin C Other Digitoxin C Enalapril C Ismn C Distraneurin C Date:05/04/00ISR Number: 3496530-XReport Type:Expedited (15-DaCompany Report #10363778 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Dutonin Tabs Dyskinesia Health (Nefazodone Hcl) PS ORAL ORAL Dystonia Professional Olanzapine SS Mania Muscle Twitching 24-Jun-2005 12:19 PM Page: 967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/00ISR Number: 3498138-9Report Type:Expedited (15-DaCompany Report #US_990623992 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Zyprexa (Olanzapine) PS 10 MG/1 DAY 2 WK Initial or Prolonged Condition Aggravated Health Risperidone C Hallucination, Auditory Professional Neutropenia Company White Blood Cell Count Representative Decreased Date:05/08/00ISR Number: 3498142-0Report Type:Expedited (15-DaCompany Report #EWC000406489 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Olanzapine PS 20 MG Phosphokinase Increased Health Valproate Sodium C Fatigue Professional Hyperhidrosis Company Hypoaesthesia Representative Joint Stiffness Other Neuroleptic Malignant Syndrome Date:05/08/00ISR Number: 3498154-7Report Type:Expedited (15-DaCompany Report #DE_000202032 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Neurocil Professional (Levomepromazine Other Maleate) C Dipiperon (Pipamperone) C Date:05/08/00ISR Number: 3498418-7Report Type:Expedited (15-DaCompany Report #AU_000401275 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Olanzapine PS Eli Lilly And Co Initial or Prolonged Abnormal Health Sarcoidosis Professional Other Date:05/08/00ISR Number: 3498575-2Report Type:Expedited (15-DaCompany Report #US_000440479 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co Professional Cogentin(Benzatropin e Mesilate) C Colace(Docusate Sodium) C 24-Jun-2005 12:19 PM Page: 968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/00ISR Number: 3498582-XReport Type:Expedited (15-DaCompany Report #EWC000406500 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Cogentin(Benzatropin Professional e Mesilate) C Date:05/08/00ISR Number: 3498583-1Report Type:Expedited (15-DaCompany Report #DE_000402347 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 2 YR Condition Aggravated Health Haemoglobin Decreased Professional Other Date:05/08/00ISR Number: 3498584-3Report Type:Expedited (15-DaCompany Report #DE_000402328 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hemiparesis Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY 1 YR Hyporeflexia Health Tavor C Hypotonia Professional Muscular Weakness Other Paraesthesia Parkinsonian Gait Date:05/08/00ISR Number: 3498619-8Report Type:Expedited (15-DaCompany Report #CA_000401405 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Olanzapine PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Diabetic Coma Health Topamax(Topiramate) C Neuropathy Peripheral Professional Renal Failure Acute Company Representative Date:05/09/00ISR Number: 3497758-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Olanzapine 10mg Tonic Convulsion Lilly PS Lilly ORAL 10MG DAY ORAL Date:05/10/00ISR Number: 3619628-1Report Type:Periodic Company Report #US_000541487 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 25 MG/1 DAY Professional 24-Jun-2005 12:19 PM Page: 969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/00ISR Number: 3499857-0Report Type:Direct Company Report # Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Olanzapine PS ORAL 10MG, 10MG HS Hospitalization - ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:05/15/00ISR Number: 3500559-2Report Type:Expedited (15-DaCompany Report #AU_000501333 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Sertraline C Professional Avapro (Irbesartan) C Other Noten (Atenolol) C Logynon Ed C Risperdal (Risperidone) C Date:05/15/00ISR Number: 3500615-9Report Type:Expedited (15-DaCompany Report #US_000235816 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Speech Disorder Professional Risperdal (Risperidone) C Date:05/15/00ISR Number: 3500616-0Report Type:Expedited (15-DaCompany Report #EWC000406500 Age:43 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Cogentin Professional (Benzatropine Other Mesilate) C Date:05/15/00ISR Number: 3500618-4Report Type:Expedited (15-DaCompany Report #EWC000406390 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Consciousness Health Neuroleptic Malignant Professional Syndrome Other Pyrexia Rhabdomyolysis Vomiting 24-Jun-2005 12:19 PM Page: 970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/00ISR Number: 3500727-XReport Type:Expedited (15-DaCompany Report #CA_000401350 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomania Foreign Zyprexa PS Eli Lilly And Co 15 MG AT Initial or Prolonged Health BEDTIME Professional Other Date:05/15/00ISR Number: 3500728-1Report Type:Expedited (15-DaCompany Report #AU_000501339 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Increased Health Metformin Professional Hydrochloride C Other Tegretal C Date:05/15/00ISR Number: 3500729-3Report Type:Expedited (15-DaCompany Report #DE_000502349 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 5 MG/3 DAY Health Tavor C Professional Akineton Retard C Other Date:05/15/00ISR Number: 3501194-2Report Type:Expedited (15-DaCompany Report #US_000440448 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:05/15/00ISR Number: 3501196-6Report Type:Expedited (15-DaCompany Report #GBS990904252 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acne Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Weight Increased Health Professional Other Date:05/15/00ISR Number: 3501199-1Report Type:Expedited (15-DaCompany Report #GBS000505856 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/00ISR Number: 3501232-7Report Type:Expedited (15-DaCompany Report #DE_000101977 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Loss Of Consciousness Health Amitriptyline C Overdose Professional Tavor (Lorazepam) C Phlebothrombosis Other Akineton (Biperiden Pulmonary Embolism Hydrochloride) C Toxicologic Test Abnormal Metoprolol C Date:05/15/00ISR Number: 3501234-0Report Type:Expedited (15-DaCompany Report #CA_000201159 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Anaemia Macrocytic Health Methotrexate C Differential White Blood Professional Trimipramine C Cell Count Abnormal Company Zopiclone C Hallucination, Auditory Representative Biperiden C Headache Other Clonazepam C Hepatic Steatosis Amoxapine C Hepatomegaly Misoprostol C Hypercholesterolaemia Naproxen C Insomnia Dextroamphetamine Iron Binding Capacity Sulfate C Total Increased Methylphenidate C Leukopenia Acetaminophen C Monocyte Count Decreased Fenofibrate C Neutropenia Vitamin B12 C Palpitations Panic Attack Tremor Vitamin B12 Decreased Date:05/18/00ISR Number: 3501432-6Report Type:Direct Company Report # Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Zyprexa PS 10MG DAILY Lethargy Pseudoephidrine SS Medication Error Date:05/22/00ISR Number: 3502603-5Report Type:Expedited (15-DaCompany Report #US_000337410 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ewing'S Sarcoma Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Initial or Prolonged Professional BEDTIME Acetaminophen C Date:05/22/00ISR Number: 3502604-7Report Type:Expedited (15-DaCompany Report #US_000440102 Age: Gender:Female I/FU:F Outcome PT Other Blood Creatine Phosphokinase Increased Extrapyramidal Disorder 24-Jun-2005 12:19 PM Page: 972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Leukocytosis Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Health Zyprexa PS Eli Lilly And Co 10 MG/2 DAY 2 WK Pyrexia Professional Depakote (Valproate Salivary Hypersecretion Company Semisodium) C Tachycardia Representative Lithium C Klonopin (Clonazepam) C Date:05/22/00ISR Number: 3502935-0Report Type:Expedited (15-DaCompany Report #GBS000505875 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Neuroleptic Malignant Health Diazepam C Syndrome Professional Carbamazepine C Other Date:05/22/00ISR Number: 3502943-XReport Type:Expedited (15-DaCompany Report #US_000541402 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa PS Eli Lilly And Co Therapeutic Professional Company Representative Date:05/22/00ISR Number: 3503066-6Report Type:Expedited (15-DaCompany Report #US_000541276 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa (Olanzapine) PS Eli Lilly And Co Therapeutic Professional Estazolam C Ventricular Hypertrophy Date:05/22/00ISR Number: 3503070-8Report Type:Expedited (15-DaCompany Report #US_000540944 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa PS Eli Lilly And Co Therapeutic Professional Stadol (Butorphanol Overdose Company Tartrate) C Toxicologic Test Abnormal Representative Sertraline C Lithium C Neurontin (Gabapentin) C Prilosec (Omeprazole) C Date:05/22/00ISR Number: 3503073-3Report Type:Expedited (15-DaCompany Report #GBS000505893 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Supraventricular 24-Jun-2005 12:19 PM Page: 973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Verapamil C Professional Insulin C Company Representative Other Date:05/22/00ISR Number: 3503275-6Report Type:Expedited (15-DaCompany Report #US_990217001 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Literature Zyprexa PS Eli Lilly And Co 25 MG/1 DAY Priapism Health Depakote C Psychotic Disorder Professional Thiothixene C Gemfibrozil C Glyburide C Cogentin C Date:05/22/00ISR Number: 3503285-9Report Type:Expedited (15-DaCompany Report #DE_000302197 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 1 MON Health Seroxat C Professional Tavor C Date:05/22/00ISR Number: 3505081-5Report Type:Expedited (15-DaCompany Report #US_000541309 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Zyprexa PS Eli Lilly And Co Bite Brain Neoplasm Condition Aggravated Lip Disorder Lipids Increased Mouth Haemorrhage Somatoform Disorder Pregnancy Tardive Dyskinesia Weight Increased Date:05/22/00ISR Number: 3505089-XReport Type:Expedited (15-DaCompany Report #DE_000502386 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 3 WK Initial or Prolonged Hyperglycaemia Health Isoptin (Verapamil Metabolic Acidosis Professional Hydrochloride) C Pco2 Decreased Other Stress Tachycardia 24-Jun-2005 12:19 PM Page: 974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/00ISR Number: 3505090-6Report Type:Expedited (15-DaCompany Report #AU_000501344 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Torsade De Pointes Health Professional Other Date:05/22/00ISR Number: 3505091-8Report Type:Expedited (15-DaCompany Report #EWC000506572 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Cholinergic Syndrome Health Xanax (Alprazolam) C Depressed Level Of Professional Sufenta (Sufentanil Consciousness Other Citrate) C Drug Withdrawal Syndrome Morphine C Hypertonia Speciafoldine (Folic Hyponatraemia Acid) C Injury Parkinane Nervous System Disorder (Trihexyphenidyl Waxy Flexibility Hydrochloride) C Date:05/22/00ISR Number: 3505092-XReport Type:Expedited (15-DaCompany Report #AU_000501350 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 AT Dehydrogenase Increased Literature BEDTIME 1 WK Clonic Convulsion Health Neazodone C Confusional State Professional Clonazepam C Disorientation Other Haloperidol C Hallucination Morphine C Heart Rate Increased Omeprazole C Hyperreflexia Cisapride C Hypertonia Betaxolol C Muscle Rigidity Neuroleptic Malignant Syndrome Paranoia Pyrexia Tachycardia Urinary Incontinence Date:05/22/00ISR Number: 3505093-1Report Type:Expedited (15-DaCompany Report #AU_000501340 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Monoparesis Consumer Anafranil Nasal Polyps Other (Clomipramine Speech Disorder Hydrochloride) C Cogentin (Benzatropine Mesilate) C 24-Jun-2005 12:19 PM Page: 975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/00ISR Number: 3504828-1Report Type:Expedited (15-DaCompany Report #A012815 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Consumer Zoloft PS Pfizer Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Inc ORAL 150.00 MG Required Non-Insulin-Dependent Professional TOTAL:BID:ORA Intervention to Dizziness L Prevent Permanent Fatigue Zyprexa SS ORAL 5.00 MG Impairment/Damage Headache TOTAL:DAILY:O Hyperglycaemia RAL Influenza Like Illness Valium C Malaise Myalgia Sedation Weight Decreased Date:05/25/00ISR Number: 3505041-4Report Type:Expedited (15-DaCompany Report #WAES 00051822 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Cogentin PS Merck And Co Inc Initial or Prolonged Anxiety Health Olanzapine SS Bipolar Disorder Professional Paroxetine SS Bradykinesia Nortriptyline SS Catatonia Lithium Carbonate C Cognitive Disorder Risperidone C Constipation Depression Drug Interaction Dry Mouth Insomnia Mania Muscle Rigidity Pyrexia Tremor Vision Blurred Date:05/26/00ISR Number: 3505923-3Report Type:Periodic Company Report #10065217 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Cytoxan PS Bristol Myers Squibb Initial or Prolonged Professional Co Pharmaceutical Research Institute 1/1 CYCLE Zyprexa (Olanzapine) SS 5 MILLIGRAM, 1/1 DAY Effexor C Date:05/30/00ISR Number: 3506351-7Report Type:Expedited (15-DaCompany Report #EWC000506724 Age:1 DY Gender: I/FU:I Outcome PT Hospitalization - Complications Of Maternal Initial or Prolonged Exposure To Therapeutic Drugs Neonatal Infection Respiratory Disorder Neonatal 24-Jun-2005 12:19 PM Page: 976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Neonatal Report Source Product Role Manufacturer Route Dose Duration Foreign Prozac PS Lilly Research Health Laboratories Div Eli Professional Lilly And Co 2 MON Company Zyprexa (Olanzapine) SS 2 MON Representative Tercian(Cyamemazine) C Other Date:05/30/00ISR Number: 3506447-XReport Type:Expedited (15-DaCompany Report #AU_000501372 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Second Degree Health Bradycardia Professional Other Date:05/30/00ISR Number: 3506448-1Report Type:Expedited (15-DaCompany Report #EWC000506670 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Hypothermia Health Zoloft (Sertraline Professional Hydrochloride) C Company Representative Other Date:05/30/00ISR Number: 3506449-3Report Type:Expedited (15-DaCompany Report #US_000541447 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Zyprexa PS Eli Lilly And Co Mental Impairment Professional Prozac (Fluoxetine Shock Hydrochloride) SS White Blood Cell Count Doxepin C Decreased Date:05/30/00ISR Number: 3506450-XReport Type:Expedited (15-DaCompany Report #US_000541593 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co 2.5 MG/4 DAY Prolonged Professional Date:05/30/00ISR Number: 3506451-1Report Type:Expedited (15-DaCompany Report #GBS000505927 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co Neutrophil Count Health Antidepressant C Decreased Professional Other 24-Jun-2005 12:19 PM Page: 977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/00ISR Number: 3506452-3Report Type:Expedited (15-DaCompany Report #DE_000502413 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Health Folsan (Folic Acid) C Professional Cipramil (Citalopram Other Hydrobromide) C Quilonum (Lithium Acetate) C Quilonum (Lithium Acetate) C Maninil "Berlin-Chemie" (Glibenclamide) C Bifiteral (Lactulose) C Sortis (Atorvastatin Calcium) C Citalopram C Date:05/30/00ISR Number: 3506453-5Report Type:Expedited (15-DaCompany Report #US_000541546 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS Eli Lilly And Co Petechiae Professional Depakote (Valproate Company Semisodium) C Representative Date:05/30/00ISR Number: 3506470-5Report Type:Expedited (15-DaCompany Report #EWC980500747 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atelectasis Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY 7 MON Hospitalization - Blood Creatine Literature Alopam C Initial or Prolonged Phosphokinase Increased Health Clozapine C Blood Test Abnormal Professional Drug Interaction Other Hyperhidrosis Hypertension Metabolic Acidosis Muscle Haemorrhage Muscle Rigidity Myoglobinuria Neuroleptic Malignant Syndrome Pain In Extremity Pallor Pneumonia Pyrexia Rhabdomyolysis Sinus Tachycardia 24-Jun-2005 12:19 PM Page: 978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/00ISR Number: 3506471-7Report Type:Expedited (15-DaCompany Report #EWC000406344 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Leukopenia Health Seroxat (Paroxetine Nasopharyngitis Professional Hydrochloride) C Other Lorazepam C Haloperidol C Impromen (Bromperidol) C Date:05/30/00ISR Number: 3506472-9Report Type:Expedited (15-DaCompany Report #US_000337022 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Initial or Prolonged Cardiac Failure Health BEDTIME Congestive Professional Albuterol C Cellulitis Aricept (Donepezil Condition Aggravated Hydrochloride) C Pneumonia Artificial Tears C Renal Failure Acute Aspirin (E.C.) (Acetylsalicyllic Acid) C Atrovent (Ipratropium Bromide) C Furosemide C Lanoxin (Digoxin) C Multivitamin C Norvasc (Amlodipine Besilate) C Insulin Novolin 70/30 C Phoslo(Calcium Acetate) C Prinivil (Lisinopril) C Reguloid (Psyllium) C Trazodone C Vitamin C C Vitamin E C Zoloft (Sertraline Hydrochloride) C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Ferrous Sulfate C Colace (Docusate Sodium) C Cortisporin Cream C Hydrocortisone C Azmacort (Triamcinolone Acetonide) C Cartia (Acetylsalicylic Acid) C Famvir (Famciclovir) C 24-Jun-2005 12:19 PM Page: 979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardizem Cd (Diltiazem Hydrochloride) C Hydralazine C K-Dur (Potassium Chloride) C Zaroxolyn (Metolazone) C Epogen (Epoetin Alfa) C Prednisone C Prevacid (Lansoprazole) C Date:05/30/00ISR Number: 3506852-1Report Type:Periodic Company Report #1999-10-0863 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Trilafon PS Schering Corp Sub Other Schering Plough Corp 2 MG Lorazepam Tablets SS ORAL 2 MG ORAL Luvox Tablets SS ORAL UNKNOWN ORAL Riperdal SS UNKNOWN Zyprexa (Olanzapine) SS Date:05/31/00ISR Number: 3506315-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Zyprexa (Olanzapine) PS 10 MG Suicidal Ideation Date:05/31/00ISR Number: 3506684-4Report Type:Direct Company Report # Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Olanzapine 10mg PS 10MG Q HS (ON Hospitalization - Convulsion PRIOR TO ADM) Initial or Prolonged Grand Mal Convulsion Required Intervention to Prevent Permanent Impairment/Damage Date:06/01/00ISR Number: 3506913-7Report Type:Expedited (15-DaCompany Report #2000020562 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Xanax PS Pharmacia And Upjohn Initial or Prolonged Cholinergic Syndrome Health Co ORAL 1 MG, QD, Drug Withdrawal Syndrome Professional ORAL Hypertonia Other Sufenta (Sufentanil Hyponatraemia Citrate) SS INTRAVENOUS IV Psychotic Disorder Morphine "Adrian" Stupor (Morphine) SS INTRAVENOUS IV Zyprexa (Olanzapine) SS ORAL 10 MG, QD, ORAL 24-Jun-2005 12:19 PM Page: 980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speciafoldine (Folic Acid) C Parkinane (Trihexyphenidyl Hydrochloride) C Date:06/02/00ISR Number: 3507842-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001423 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Risperdal PS Janssen Research Fdn Initial or Prolonged Akathisia Health Div Johnson And Anxiety Professional Johnson ORAL MG, DAILY, Bradykinesia ORAL Catatonia Lithium Carbonate Cognitive Disorder (Lithium Carbonate) SS MG, DIALY Constipation Paroxetine Depression (Paroxetine) SS MG, DAILY Drug Interaction Olanzapine Dry Mouth (Olanzapine) SS MG, DAILY Fatigue Benztropine Insomnia (Benztropine) SS MG, DAILY Irritability Nortriptyline SS MG, DAILY Mania Muscle Rigidity Parkinsonism Pressure Of Speech Pyrexia Thinking Abnormal Tremor Vision Blurred Date:06/05/00ISR Number: 3508002-4Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Olanzapine 10mg PS ORAL 10 MG ONCE Hospitalization - Diabetes Mellitus DAILY ORAL Initial or Prolonged Diabetic Ketoacidosis Effexor C Polydipsia Depakote C Polyuria Trazadone C Vomiting Date:06/05/00ISR Number: 3508874-3Report Type:Expedited (15-DaCompany Report #CA_980600027 Age:34 YR Gender:Male I/FU:I Outcome PT Hospitalization - Clonic Convulsion Initial or Prolonged Condition Aggravated Convulsion Dizziness Drug Interaction Drug Level Above Therapeutic Dry Mouth Electroencephalogram Abnormal Hallucination, Auditory 24-Jun-2005 12:19 PM Page: 981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obsessive-Compulsive Disorder Sedation Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Literature Chlorimipramine C Health Professional Other Date:06/05/00ISR Number: 3509338-3Report Type:Expedited (15-DaCompany Report #EWC000506762 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS Eli Lilly And Co Health Flurazepam C Professional Citalopram C Other Date:06/05/00ISR Number: 3509346-2Report Type:Expedited (15-DaCompany Report #00P-163-0089291-00(1) Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Depakene PS Abbott Laboratories Initial or Prolonged Drug Interaction Professional Pharmaceutical Leukopenia Other Products Div ORAL 750 MG, 1 IN Neutropenia 1 HR , PER Suicidal Ideation ORAL Olanzapine (Olanzapine) SS ORAL 5 MG, 1 IN 1 D, PER ORAL Lamotrigrine SS ORAL 100 MG, 1 IN 1 D Amfebutamone Hydrochloride (Amfebutamone Hydrochloride) C Clonazepam (Clonazepam) C Date:06/05/00ISR Number: 3509447-9Report Type:Expedited (15-DaCompany Report #CA_000101113 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Haemoglobin Decreased Health Stelazine Leukopenia Professional (Trifluoperazine Neutropenia Company Hydrochloride) C Thrombocytopenia Representative Benztropine C Methotrimeprazine C Date:06/05/00ISR Number: 3509448-0Report Type:Expedited (15-DaCompany Report #DE_000302199 Age:41 YR Gender:Male I/FU:F Outcome PT Hospitalization - Cardiac Disorder Initial or Prolonged Electrocardiogram St Segment Depression 24-Jun-2005 12:19 PM Page: 982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocardial Infarction Wolff-Parkinson-White Syndrome Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Literature Novadral Health (Norfenefrine Professional Hydrohcloride) C Other Vivimed Gegen Kopfschmerzen C Voltaren Idiclofenac Sodium) C Zyrtec (Cetirizine Hydrochloride) C Date:06/05/00ISR Number: 3509463-7Report Type:Expedited (15-DaCompany Report #2000021611US Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Study Zyvox PS Pharmacia And Upjohn Intervention to Clonic Convulsion Health Co ORAL 600 MG, BID, Prevent Permanent Convulsion Professional ORAL Impairment/Damage Drug Interaction Paxil (Paroxetine Fatigue Hydrochloride) SS ORAL 30 MG, HS, Grand Mal Convulsion ORAL Hypotonia Efavirenz Lethargy (Efavirenz) SS ORAL 600 MG, HS, Loss Of Consciousness ORAL Monoparesis Remeron Movement Disorder (Mirtazapine) SS ORAL 30 MG, HS, Muscle Twitching ORAL Serotonin Syndrome Zyprexa (Olanzapine) SS ORAL 5 MG, HS, Tinnitus ORAL Bactrim Ds (Trimethoprim, Sulfamethoxazole) C Azt (Zidovudine) C Abacavir (Abacavir) C Ddi (Didanosine) C Zinc (Zinc) C Vancomycin (Vancomycin) C Ambien (Zolpidem Tartrate) C Coumadin (Warfarin Sodium) C Date:06/05/00ISR Number: 3509478-9Report Type:Expedited (15-DaCompany Report #AU_991200939 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY Convulsion Health Kemadrin C Professional 24-Jun-2005 12:19 PM Page: 983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/00ISR Number: 3509482-0Report Type:Expedited (15-DaCompany Report #EWC000105506 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Convulsion Health Nozinan C Electrocardiogram Qrs Professional Mepronizine C Complex Prolonged Other Seresta C Electrocardiogram Qt Prolonged Hyperkalaemia Suicide Attempt Date:06/05/00ISR Number: 3509483-2Report Type:Expedited (15-DaCompany Report #DE_000502386 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 3 WK Initial or Prolonged Cardiogenic Shock Health Isoptin C Hyperglycaemia Professional Aspirin C Hypotension Other Metabolic Acidosis Pco2 Decreased Skin Disorder Tachycardia Date:06/05/00ISR Number: 3509485-6Report Type:Expedited (15-DaCompany Report #US_000235232 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Health Zyprexa PS Eli Lilly And Co 20 MG/ 1 DAY Initial or Prolonged Diabetic Ketoacidosis Professional Depakote C Other Hyperglycaemia Nausea Polydipsia Polyuria Date:06/05/00ISR Number: 3509486-8Report Type:Expedited (15-DaCompany Report #EWC000306015 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10MG/ DAY Weight Increased Health Prozac (Fluoxetine Professional Hydrochloride) SS 40 MG/ DAY Company Representative Date:06/05/00ISR Number: 3509487-XReport Type:Expedited (15-DaCompany Report #EWC000305968 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/ DAY Health Effexor C Professional Tranxene C Tercian C Parkinane C Stilnox C Heptaminol C 24-Jun-2005 12:19 PM Page: 984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/00ISR Number: 3509489-3Report Type:Expedited (15-DaCompany Report #DE_000502349 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/ 3 DAY Health Tavor C Professional Akineton Retard C Granulocyte C Date:06/05/00ISR Number: 3510006-2Report Type:Expedited (15-DaCompany Report #GBS000505952 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Other Pulmonary Embolism Health Fluphenazine C Professional Other Date:06/05/00ISR Number: 3510007-4Report Type:Expedited (15-DaCompany Report #EWC000506789 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholinergic Syndrome Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Depressed Level Of Health Morphine C Consciousness Professional Xanax C Drug Withdrawal Syndrome Other Sufenta C Head Injury Parkinane C Hypertonia Speciafoldine C Hyponatraemia Road Traffic Accident Stupor Date:06/05/00ISR Number: 3510008-6Report Type:Expedited (15-DaCompany Report #EWC000506738 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Zyprexa PS Eli Lilly And Co 15 MG Hospitalization - Gastric Ulcer Haemorrhage Health Mogadon C Initial or Prolonged Gastrointestinal Professional Seropram C Haemorrhage Molsidolat C Hyperglycaemia Ciproxin C Insulin Mixtard C Date:06/05/00ISR Number: 3510014-1Report Type:Expedited (15-DaCompany Report #AU_000501409 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Foreign Zyprexa PS Eli Lilly And Co Haemorrhage Health Professional Other 24-Jun-2005 12:19 PM Page: 985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/00ISR Number: 3510015-3Report Type:Expedited (15-DaCompany Report #AU_000501393 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG /DAY Health Professional Other Date:06/05/00ISR Number: 3510016-5Report Type:Expedited (15-DaCompany Report #US_000541951 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythropenia Health Zyprexa PS Eli Lilly And Co 30 MG / 1 AT Haematocrit Decreased Professional BEDTIME Haemoglobin Decreased Topamax (Topiramate) C Leukopenia Coumadin (Warfarin Thrombocytopenia Sodium) C Cogentin (Benzatropine Mesilate) C Loxitane (Loxapine Succinate) C Vitamin D C Ativan(Lorazepam) C Restoril (Temazepam) C Multivitamin C Levofloxacin C Date:06/05/00ISR Number: 3510017-7Report Type:Expedited (15-DaCompany Report #GBS000505951 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Foreign Zyprexa PS Eli Lilly And Co 20 MG /DAY Decreased Health Droperidol C Professional Other Date:06/05/00ISR Number: 3510018-9Report Type:Expedited (15-DaCompany Report #US_000542022 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Consumer Zyprexa PS Eli Lilly And Co 5 MG /1 DAY Luvox (Fluvoxamine Maleate) C Celexa (Citalopram Hydrobromide) C Date:06/05/00ISR Number: 3510019-0Report Type:Expedited (15-DaCompany Report #US_000541741 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa PS Eli Lilly And Co 20 MG / DAY 2 YR Initial or Prolonged Liver Function Test Professional Trazodone C Abnormal Company Serax (Oxazepam) C Representative 24-Jun-2005 12:19 PM Page: 986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/00ISR Number: 3510020-7Report Type:Expedited (15-DaCompany Report #US_000542341 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co 5 MG / 1 AT Medication Error Professional BEDTIME Date:06/05/00ISR Number: 3510028-1Report Type:Expedited (15-DaCompany Report #DE_000502446 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Carbamazepine C Professional Other Date:06/05/00ISR Number: 3510261-9Report Type:Expedited (15-DaCompany Report #US_000542025 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Consumer Zyprexa PS Eli Lilly And Co 10 MG /1 DAY Haldol (Haloperidol) C Date:06/06/00ISR Number: 3508821-4Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperthyroidism Lorazepam Tab PS ORAL 0.5MG PO Olanzapine Tab SS ORAL 5MG PO Date:06/06/00ISR Number: 3508919-0Report Type:Direct Company Report # Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Depakote 250mg And Required 500mg Abbott PS Abbott ORAL 500MG BID Intervention to ORAL Prevent Permanent Zyprexa 2.5, 5, 7.5 Impairment/Damage And 10mg Lilly SS Lilly ORAL 7.5MG HS ORAL Date:06/08/00ISR Number: 3510568-5Report Type:Expedited (15-DaCompany Report #A012014 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Zyrtec PS Pfizer Inc ORAL ORAL Initial or Prolonged Medication Error Professional Zyprexa SS ORAL 10.00 MG Required Sedation TOTAL:ORAL Intervention to Levaquin C Prevent Permanent Combivent C Impairment/Damage Allegra C Prednisone Taper C Mycelex Troche C Synthroid C Paxil C Ntg Sl C Prevacid C Pravachol C 24-Jun-2005 12:19 PM Page: 987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prinivil C Plavix C Atenolol C Date:06/09/00ISR Number: 3511007-0Report Type:Expedited (15-DaCompany Report #A012815 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zoloft PS Pfizer Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Inc ORAL 150.00 MG Required Non-Insulin-Dependent Professional TOTAL:BID:ORA Intervention to Dizziness L Prevent Permanent Fatigue Zyprexa SS ORAL 5.00 MG Impairment/Damage Headache TOTAL:DAILY:O Influenza Like Illness RAL Malaise Valum C Myalgia Sedation Weight Decreased Date:06/09/00ISR Number: 3519075-7Report Type:Periodic Company Report #226637 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Accutane PS Hlr Technology ORAL ORAL Schizophrenia Professional Zyprexa SS Date:06/12/00ISR Number: 3511358-XReport Type:Direct Company Report # Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Reaction Olanzapine PS Date:06/12/00ISR Number: 3511408-0Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Zyprexa PS 2 YR Life-Threatening Diarrhoea Lithium C Inappropriate Affect Xanax C Sleep Attacks Sudden Death Date:06/12/00ISR Number: 3512258-1Report Type:Expedited (15-DaCompany Report #EWC000506821 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Required Status Epilepticus Health Intervention to Professional Prevent Permanent Company Impairment/Damage Representative 24-Jun-2005 12:19 PM Page: 988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/00ISR Number: 3512261-1Report Type:Expedited (15-DaCompany Report #AU_000501419 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Foreign Zyprexa PS Eli Lilly And Co Health Serzone C Professional Date:06/12/00ISR Number: 3512475-0Report Type:Expedited (15-DaCompany Report #EWC000506839 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Lithium PS 3600 MG/DAY Initial or Prolonged Suicide Attempt Study Olanzapine SS 7.5 MG/DAY Health Lorazepam C Professional Other Date:06/12/00ISR Number: 3512478-6Report Type:Expedited (15-DaCompany Report #US_000642946 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS Eli Lilly And Co 5 MG/ 1 DAY Other Professional Company Representative Date:06/12/00ISR Number: 3512482-8Report Type:Expedited (15-DaCompany Report #GBS000505878 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Foreign Zyprexa PS Eli Lilly And Co 280 MG Initial or Prolonged Overdose Health Lamotrigine C Peripheral Nerve Injury Professional Seroxat (Paroxetine Company Hydrochloride) C Representative Other Date:06/12/00ISR Number: 3512485-3Report Type:Expedited (15-DaCompany Report #US_000542556 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Health Zyprexa PS Eli Lilly And Co 4 MON Increased Professional Tegretol Diabetes Mellitus (Carbamazepine) C Glucose Tolerance Paxil (Paroxetine Decreased Hdyrochloride) C Pancreatitis Necrotising Depakote (Valproate Semisodium) C Date:06/12/00ISR Number: 3512488-9Report Type:Expedited (15-DaCompany Report #US_000642765 Age:48 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased Diabetic Ketoacidosis 24-Jun-2005 12:19 PM Page: 989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gamma-Glutamyltransferase Increased Hyperglycaemia Report Source Product Role Manufacturer Route Dose Duration Hypertriglyceridaemia Health Zyprexa PS Eli Lilly And Co 20 MG/.DAY Mental Impairment Professional Trazodone(Oxazepam) C Pancreatitis Valproic Acid C Weight Decreased Atenolol C Weight Increased Diltiazem C Hydrochlorothiazide C Date:06/12/00ISR Number: 3512491-9Report Type:Expedited (15-DaCompany Report #EWC000506819 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY Haematemesis Health Noxinan Overdose Professional (Levomepromazine) C Sedation Company Aspirine Representative (Acetylsalicylic Other Acid) C Date:06/12/00ISR Number: 3512509-3Report Type:Expedited (15-DaCompany Report #GBS000505893 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Supraventricular Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Tachycardia Health Verapamil C Professional Insulin C Company Representative Date:06/12/00ISR Number: 3512511-1Report Type:Expedited (15-DaCompany Report #US_000337604 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa PS Eli Lilly And Co 5 MG / 1DAY Pulmonary Embolism Professional Synthroid Company (Levothyroxine Representative Sodium) C Date:06/12/00ISR Number: 3512558-5Report Type:Expedited (15-DaCompany Report #EWC000506762 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa PS Eli Lilly And Co Drug Toxicity Health Flurazepam C Hepatic Steatosis Professional Citalopram C Toxicologic Test Abnormal Other Date:06/12/00ISR Number: 3512561-5Report Type:Expedited (15-DaCompany Report #EWC990603732 Age: Gender:Male I/FU:F Outcome PT Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs 24-Jun-2005 12:19 PM Page: 990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congenital Urinary Tract Obstruction Kidney Malformation Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Lexomil (Bromazepam) C Professional Other Date:06/13/00ISR Number: 3511982-4Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neurodermatitis Zyprexa 7.5mg Psoriasis (Lilly) PS Lilly ORAL 7.5MG 2 TAB Rash Generalised ORALLY Scab Date:06/13/00ISR Number: 3512556-1Report Type:Expedited (15-DaCompany Report #GBS000505927 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Neutrophil Count Health Antidepressant C Decreased Professional Platelet Count Decreased Other Date:06/14/00ISR Number: 3513974-8Report Type:Expedited (15-DaCompany Report #S00-FRA-00774-01 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Citalopram PS Forest Laboratories Initial or Prolonged Increased Health Inc Hepatic Enzyme Increased Professional Olanzapine SS 30 MG QD Company Prazepam SS 30 MG QD Representative Amisulpride SS 300 MG QD Other Date:06/19/00ISR Number: 3515125-2Report Type:Direct Company Report # Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Lipitor 10mg PS ORAL QD PO Initial or Prolonged Phosphokinase Increased Zyprexa 20mg SS ORAL QHS PO Muscular Weakness Myositis Date:06/19/00ISR Number: 3515198-7Report Type:Direct Company Report #USP 081134 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec 10mg PS Pfizer Zyprexa 10mg (Olanzapine) SS Lilly 24-Jun-2005 12:19 PM Page: 991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3515571-7Report Type:Expedited (15-DaCompany Report #US_000643346 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Axid PS Eli Lilly And Co 150 MG/2 DAY Neutropenia Professional Zyprexa (Olanzapine) SS 15 MG/1 DAY 2 MON Multivitains C K-Phos Neutral C Colace (Docusate Sodium) C Simethicone C Calcium Carbonate C Date:06/19/00ISR Number: 3515985-5Report Type:Expedited (15-DaCompany Report #US_000643175 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Increased Professional Renal Impairment Date:06/19/00ISR Number: 3515987-9Report Type:Expedited (15-DaCompany Report #US_000643261 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bite Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Other Blood Creatine Professional Eskalith Cr (Lithium Phosphokinase Increased Carbonate) C Convulsion Fatigue Mania Medication Error Myocardial Infarction Pyrexia Tongue Disorder Weight Increased Date:06/19/00ISR Number: 3515990-9Report Type:Expedited (15-DaCompany Report #AU_000601436 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co Health Professional Company Representative Other Date:06/19/00ISR Number: 3515992-2Report Type:Expedited (15-DaCompany Report #DE_000602513 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Health Anafranil Professional (Clomipramine Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3515996-XReport Type:Expedited (15-DaCompany Report #DE_000602522 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Pulmonary Embolism Health Fluctin (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Other Date:06/19/00ISR Number: 3515998-3Report Type:Expedited (15-DaCompany Report #EWC000606928 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Health Seduxen (Diazepam)X C Professional Company Representative Other Date:06/19/00ISR Number: 3516002-3Report Type:Expedited (15-DaCompany Report #US_000643052 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co 1.25 MG/1 DAY Professional Sinemet C Company Sulindac C Representative Detrol (Tolterodine L-Tartrate) C Aricept (Donepezil Hydrochloride) C Date:06/19/00ISR Number: 3516004-7Report Type:Expedited (15-DaCompany Report #10363778 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Serzone PS Bristol Myers Squibb Initial or Prolonged Dyskinesia Health Co Pharmaceutical Other Mania Professional Research Institute ORAL 400 Muscle Twitching Other MILLIGRAM, 1/1 DAY ORAL Olanzapine SS Date:06/19/00ISR Number: 3516005-9Report Type:Expedited (15-DaCompany Report #US_000643263 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co 5 MG/3 DAY Professional Lanoxin (Digoxin) C Hytrin (Terazosin Hydrochloride) C Acyclovir C 24-Jun-2005 12:19 PM Page: 993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3516022-9Report Type:Expedited (15-DaCompany Report #US_000643180 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Disorder Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Professional Carbamazepine C Nicotine Dermal Patch (Nicotine Resin) C Lomotil C Lorazepam C Cortisporin Ophthalmic Suspension C Estradiol C Date:06/19/00ISR Number: 3516023-0Report Type:Expedited (15-DaCompany Report #DE_000602511 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Decreased Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 2 WK Blood Creatinine Health Pramipexole C Increased Professional Comtess C Chromaturia Other .. C Rhabdomyolysis .. C Date:06/19/00ISR Number: 3516027-8Report Type:Expedited (15-DaCompany Report #EWC000606906 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Blood Creatinine Health Decreased Professional Haemoglobin Decreased Other Hepatomegaly Hyperglycaemia Hypertension Hypokalaemia Hyponatraemia Inappropriate Antidiuretic Hormone Secretion Injury Leukocytosis Liver Function Test Abnormal Mean Cell Volume Increased Polydipsia Psychogenic Red Blood Cell Sedimentation Rate Increased Urinary Incontinence 24-Jun-2005 12:19 PM Page: 994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3516030-8Report Type:Expedited (15-DaCompany Report #US_000337553 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa PS Eli Lilly And Co 210 MG/1 DAY Disseminated Professional Cannabis C Intravascular Coagulation Company Overdose Representative Date:06/19/00ISR Number: 3516162-4Report Type:Expedited (15-DaCompany Report #EWC000506819 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Tracheal Foreign Zyprexa PS Eli Lilly And Co 25 MG /DAY Haematemesis Health Nozinan Overdose Professional (Levomepromazine) C Sedation Company Aspirine Representative (Acetylsalicylic Other Acid) C Date:06/19/00ISR Number: 3516163-6Report Type:Expedited (15-DaCompany Report #EWC990202785 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 5 MG DAY Life-Threatening Blood Bicarbonate Health UNKNOWN Hospitalization - Decreased Professional Clomipramine C Initial or Prolonged Blood Creatinine Other Lithium Carbonate C Other Increased Tegretol Blood Glucose Increased (Carbamazepine) C Blood Ph Decreased Cardiac Arrest Cyanosis Dyspnoea Electrocardiogram Qrs Complex Prolonged Hepatosplenomegaly Hyperglycaemia Hyperkalaemia Hypotension Liver Disorder Metabolic Acidosis Muscle Rigidity Myalgia Nephritis Interstitial Neuroleptic Malignant Syndrome Oxygen Saturation Decreased Renal Impairment Respiratory Failure Sedation Date:06/19/00ISR Number: 3516164-8Report Type:Expedited (15-DaCompany Report #EWC990603732 Age: Gender:Male I/FU:F Outcome PT Congenital Anomaly Complications Of Maternal Exposure To Therapeutic 24-Jun-2005 12:19 PM Page: 995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drugs Delirium Kidney Malformation Medication Error Report Source Product Role Manufacturer Route Dose Duration Pregnancy Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 10 MG DAY Health UNKNOWN Professional Lexomil (Bromazepam) C Other Date:06/19/00ISR Number: 3516165-XReport Type:Expedited (15-DaCompany Report #DE_000402277 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 10 MG DAY Lymphopenia Health UNKNOWN 4 WK Professional Other Date:06/19/00ISR Number: 3516168-5Report Type:Expedited (15-DaCompany Report #GBS000505927 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Leukopenia Health Antidepressant C Neutropenia Professional Thrombocytopenia Date:06/19/00ISR Number: 3516176-4Report Type:Expedited (15-DaCompany Report #2000-ES-00128 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Atrovent PS Boehringer Ingelheim Sudden Death Other Pharmaceuticals Inc RESPIRATORY (INHALATION) 15 ML NR IH Zyprexa (Olanzapine) SS ORAL 10 MG PO Zuclopentixol Decanoate SS INTRAMUSCULAR 200 MG IM Zuclopentixol Acetate SS INTRAMUSCULAR 50 MG IM Tranxilium SS ORAL DOSE UNK PO Noctamid SS ORAL 2 MG PO Rivotril SS ORAL 1 MG PO Clarithromycin SS ORAL 500 MG PO Methadone C ORAL 40 MG PO Date:06/19/00ISR Number: 3516203-4Report Type:Expedited (15-DaCompany Report #AU-000501372 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 20 MG /DAY Initial or Prolonged Second Degree Health Bradycardia Professional 24-Jun-2005 12:19 PM Page: 996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3516205-8Report Type:Expedited (15-DaCompany Report #EWC000105396 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Foreign Zyprexa PS Eli Lilly And Co 480 MG/DAY Other Cardiac Arrest Health Xanax C Cardiogenic Shock Professional Coma Other Completed Suicide Hepatic Failure Hypotension Intentional Misuse Renal Failure Date:06/19/00ISR Number: 3516207-1Report Type:Expedited (15-DaCompany Report #EWC000406363 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autoimmune Disorder Foreign Zyprexa PS Eli Lilly And Co 20 MG / DAY Dermatitis Health Stresam C Lymphopenia Professional Imovane C Neutrophil Count Other Decreased Thrombocytopenia Date:06/19/00ISR Number: 3516210-1Report Type:Expedited (15-DaCompany Report #EWC000406384 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Dermatitis Health Tranxene C Headache Professional Stilnox C Meningism Company Lepticur C Musculoskeletal Stiffness Representative Photophobia Posture Abnormal Date:06/19/00ISR Number: 3516211-3Report Type:Expedited (15-DaCompany Report #EWC000506738 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Zyprexa PS Eli Lilly And Co 15 MG Hospitalization - Diabetes Mellitus Health Mogadon C Initial or Prolonged Gastrointestinal Professional Seropram C Haemorrhage Molsidolat C Glycosylated Haemoglobin Ciproxin C Increased Insulin Mixtard C Hyperglycaemia Small Intestinal Haemorrhage Date:06/20/00ISR Number: 3516372-6Report Type:Expedited (15-DaCompany Report #238238 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clonopin PS Hoffmann La Roche Other Inc ORAL 1 MG DAILY ORAL 24-Jun-2005 12:19 PM Page: 997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa (Olanzapine) 10 Mg SS ORAL 10 MG DAILY ORAL Zuclopenthixol Decanoate (Zuclopenthixol) SS INTRAMUSCULAR 200 MG 1 PER MONTH INTRAMUSCULAR Zuclopenthixol Acetate (Zuclopenthixol) SS INTRAMUSCULAR 50 MG INTRAMUSCULAR Noctamid (Lormetazepam) 2 Mg SS ORAL 2 MG DAILY ORAL Tranxilium (Clorazepate Dipotassium) 5 Mg SS ORAL ORAL Clarithromycine (Clarithromycin) SS ORAL 500 MG DAILY ORAL Metadone (Methadone Hydrochloride) SS ORAL 40 MG DAILY ORAL Atrovent Inhaler (Ipratropium Bromide) 15 Ml SS RESPIRATORY (INHALATION) INHALATION Date:06/26/00ISR Number: 3519507-4Report Type:Expedited (15-DaCompany Report #GBS000505951 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Neutropenia Health Droperidol C Professional Date:06/26/00ISR Number: 3519510-4Report Type:Expedited (15-DaCompany Report #DE_000602511 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 2 WK Initial or Prolonged Aminotransferase Health Pramipexole C Increased Professional Comtess C Blood Creatine Other Phosphokinase Increased Blood Creatinine Increased Chromaturia Rhabdomyolysis Date:06/26/00ISR Number: 3519512-8Report Type:Expedited (15-DaCompany Report #DE_991101742 Age:26 YR Gender:Female I/FU:F Outcome PT Hospitalization - Antibody Test Positive Initial or Prolonged Antinuclear Antibody Positive 24-Jun-2005 12:19 PM Page: 998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bacterial Infection Blood Immunoglobulin E Increased Report Source Product Role Manufacturer Route Dose Duration Cerebral Infarction Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Hemiparesis Professional Contraceptivum E C Speech Disorder Other Systemic Lupus Erythematosus Transient Ischaemic Attack Weight Increased Date:06/26/00ISR Number: 3519514-1Report Type:Expedited (15-DaCompany Report #EWC000506789 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholinergic Syndrome Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Depressed Level Of Health Morphine C Consciousness Professional Xanax C Drug Withdrawal Syndrome Other Sufenta C Hypertonia Parkinane C Hyponatraemia Speciafoldine C Road Traffic Accident Skull Fracture Stupor Date:06/26/00ISR Number: 3519517-7Report Type:Expedited (15-DaCompany Report #US_000439380 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cannabinoids Health Zyprexa PS Eli Lilly And Co 210 MG/DAY Hospitalization - Increased Professional Cannabis C Initial or Prolonged Disseminated Intravascular Coagulation Overdose Date:06/26/00ISR Number: 3519520-7Report Type:Expedited (15-DaCompany Report #US_000643261 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bite Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Other Blood Creatine Professional Eskalith Cr C Phosphokinase Increased Convulsion Fatigue Hypothalamo-Pituitary Disorders Mania Medication Error Myocardial Infarction Necrosis Pituitary Tumour Pyrexia Weight Decreased Weight Increased 24-Jun-2005 12:19 PM Page: 999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/00ISR Number: 3520114-8Report Type:Expedited (15-DaCompany Report #EWC000606993 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Sudden Death Health Cisordinol Professional (Clopenthixol Other Hydrochloride) C Tranxilium (Clorazepate Dipotassium) C Date:06/26/00ISR Number: 3520115-XReport Type:Expedited (15-DaCompany Report #GBS000606094 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Melleril Professional (Thioridazine Company Hydrochloride) C Representative Lorazepam C Other Date:06/26/00ISR Number: 3520116-1Report Type:Expedited (15-DaCompany Report #US_000338309 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperosmolar Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Coma Professional Depakote (Valproate Hyperglycaemia Semisodium) C Mental Impairment Wellbutrin (Amfebutamone Hydrochloride) C Date:06/26/00ISR Number: 3520118-5Report Type:Expedited (15-DaCompany Report #US_000643502 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Sudden Death Professional Delatesestryl (Testosterone Enantate) C Vitamin E C Vitamin B C Calcium C Acetaminophen C Date:06/26/00ISR Number: 3520119-7Report Type:Expedited (15-DaCompany Report #US_000643547 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematochezia Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Hypotension Health Sertraline C Rectal Haemorrhage Professional Donepezil C Vitamin E C Aspirin C 24-Jun-2005 12:19 PM Page: 1000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/00ISR Number: 3520120-3Report Type:Expedited (15-DaCompany Report #US_000643449 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 6 MON Ecchymosis Prevacid Lethargy (Lansoprazole) C Skin Discolouration Reglan (Metoclopramide) C Vioxx (Rofecoxib) C Metamucil (Psyllium Hydrophilic Mucilloid) C Lactulose C Date:06/26/00ISR Number: 3520121-5Report Type:Expedited (15-DaCompany Report #EWC000607013 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Decreased Appetite Health Fatigue Professional Gastrointestinal Other Haemorrhage Headache Nausea Thrombocytopenia Vertigo Date:06/26/00ISR Number: 3520330-5Report Type:Expedited (15-DaCompany Report #US_980503401 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Bone Marrow Depression Health Combivir C Haematocrit Decreased Professional Viracept (Nelfinavir Haemoglobin Decreased Mesilate) C Pneumonia Date:06/26/00ISR Number: 3520333-0Report Type:Expedited (15-DaCompany Report #EWC000606949 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Cardiomegaly Health Efexor (Venlafaxine Electrocardiogram Professional Hydrochloride) C Abnormal Other Rivotril Pulmonary Congestion (Clonazepam) C Date:06/26/00ISR Number: 3520335-4Report Type:Expedited (15-DaCompany Report #EWC000606991 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Sudden Death Health Zuclopenthixol Professional Decanoate C Other Zuclopenthixol Acetate C 24-Jun-2005 12:19 PM Page: 1001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tranxilium (Clorazepate Dipotassium) C Noctamid (Lormetazepam) C Rivotril (Clonazepam) C Clarithromycin C Metadon C Atrovent (Ipratropium Bromide) C Date:06/26/00ISR Number: 3619846-2Report Type:Periodic Company Report #US_000235366 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Consumer Zyprexa PS Eli Lilly And Co 4 WK Therapeutic Tegretol C Topamax C Neurontin C Date:06/27/00ISR Number: 3520092-1Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Tenderness Health Olanzapine 7.5mg Hypertrophy Breast Professional Tablets Lilly PS Lilly 15 MG HS Nipple Pain Date:06/27/00ISR Number: 3520141-0Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Depakote 250 Mg And Hospitalization - 500 Mg Tab Abbott PS Abbott ORAL 250MG QAM, Initial or Prolonged 500 MG QHS ORAL Olanzapine 2.5 Mg And 5 Mg Tab SS Lilly ORAL 2.5MG AM, 5MG HS ORAL Vpa C Date:06/27/00ISR Number: 3520584-5Report Type:Expedited (15-DaCompany Report #203688 Age:58 YR Gender:Female I/FU:F Outcome PT Other Abdominal Pain Anaemia Bone Marrow Depression Cough Decreased Appetite Dizziness Gastrointestinal Disorder Haemoglobin Decreased Hip Fracture Hyponatraemia 24-Jun-2005 12:19 PM Page: 1002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukopenia Neutropenia Pain In Extremity Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Clonopin PS Hoffmann La Roche Urinary Incontinence Other Inc ORAL ORAL Viral Infection Trileptal SS ORAL 1050 MG DAILY ORAL Zyprexa SS 5 MG 1 PER DAY Seronil SS 20 MG 1 PER DAY Spesicor C Primaspan C Prepulsid C Thyroxin C Zocor C Nitrosid C Actrapid Insulin C Protaphan C Hydantin C Antepsin C Deprakine C Absenor C Panacod C Date:06/29/00ISR Number: 3522364-3Report Type:Expedited (15-DaCompany Report #00P-144-0091167-00 (0) Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Foreign Tranxene PS Abbott Laboratories Sudden Death Health Pharmaceutical Professional Products Div ORAL 45 MG, 1 IN 1 D, PER ORAL Olanzapine (Olazapine) SS ORAL 20 MG, 1 IN 1 D, PER ORAL Clopenthixol Hydrochloride (Clopenthixol Hydrochloride) SS INTRAMUSCULAR 800 MG, 1 IN 1 M, INTRAMUSCULAR AND INTRAVENOUS Ethanol (Ethanol) SS Diamorphine (Diamorphine) SS Cocaine (Cocaine) SS Date:06/30/00ISR Number: 3525684-1Report Type:Periodic Company Report #2000031 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Keppra PS Ucb Pharma Inc Initial or Prolonged Sedation Professional Olanzapine SS Suicide Attempt 24-Jun-2005 12:19 PM Page: 1003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/00ISR Number: 3523339-0Report Type:Expedited (15-DaCompany Report #2000021611US Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Study Zyvox PS Pharmacia And Upjohn Intervention to Coma Health Co ORAL 600 MG, BID, Prevent Permanent Convulsion Professional ORAL Impairment/Damage Electroencephalogram Paxil (Paroxetine Abnormal Hydrochloride) SS ORAL 30 MG, HS, Fatigue ORAL Gait Disturbance Efavirenz(Efavirenz) SS ORAL 600 MG, HS, Grand Mal Convulsion ORAL Lethargy Remeron(Mirtazapine) SS ORAL 30 MG, HS, Loss Of Consciousness ORAL Movement Disorder Zyprexa(Olanzapine) SS ORAL 5 MG, HS, Muscle Twitching ORAL Paresis Bactrim Ds Tinnitus (Trimethoprim, Sulfamethoxazole) C Azt (Zidovudine) C Abacavir (Abacavir) C Ddi (Didanosine) C Zinc (Zinc) C Vancomycin (Vancomycin) C Ambien (Zolpidem Tartrate) C Coumadin (Warfarin Sodium) C Date:07/03/00ISR Number: 3523623-0Report Type:Expedited (15-DaCompany Report #DE_000602572 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY 1 YR Initial or Prolonged Petechiae Health Pruritus Professional Pyrexia Other Shock Date:07/03/00ISR Number: 3523625-4Report Type:Expedited (15-DaCompany Report #DE_000602577 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Phosphokinase Increased Health Levomepromazine C Delirium Professional Fluanxol Pyrexia Other (Flupentixol Dihydrochloride) C Date:07/03/00ISR Number: 3523630-8Report Type:Expedited (15-DaCompany Report #EWC000607064 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Disipal Professional (Orphenadrine Other Hydrochloride) C Truxal 24-Jun-2005 12:19 PM Page: 1004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Chlorprothixene Hydrochloride) C Serenase (Haloperidol) C Rivotril (Clonazepam) C Date:07/03/00ISR Number: 3523632-1Report Type:Expedited (15-DaCompany Report #US_000643590 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Gastrointestinal Professional Aricept (Donepezil Haemorrhage Hydrochloride) C Psychotic Disorder Celexa (Citalopram Hydrobromide) C Wellbutrin (Amfebutamone Hydrochloride) C Date:07/03/00ISR Number: 3523635-7Report Type:Expedited (15-DaCompany Report #US_000643705 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Zyprexa PS Eli Lilly And Co Professional Date:07/03/00ISR Number: 3523636-9Report Type:Expedited (15-DaCompany Report #US_000644035 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Abnormal Professional Overdose Company Representative Date:07/03/00ISR Number: 3523637-0Report Type:Expedited (15-DaCompany Report #AU_000601461 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Body Temperature Health Increased Professional Other Date:07/03/00ISR Number: 3523849-6Report Type:Expedited (15-DaCompany Report #US_00337268 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY 24-Jun-2005 12:19 PM Page: 1005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/00ISR Number: 3523851-4Report Type:Expedited (15-DaCompany Report #US_000643052 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Eli Lilly And Co 1.25 MG/1 DAY Leukopenia Professional Sinemet C Upper Respiratory Tract Company Sulindac C Infection Representative Detrol C Aricept C Avapro C Cardura C Date:07/03/00ISR Number: 3523853-8Report Type:Expedited (15-DaCompany Report #US_000643449 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Contact Consumer Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Dyskinesia Health Prevacid C Ecchymosis Professional Reglan C Haematocrit Decreased Vioxx C Haemoglobin Decreased Metamucil C Lethargy Lactulose C Lymphocyte Count Decreased Skin Discolouration Weight Decreased Date:07/03/00ISR Number: 3523855-1Report Type:Expedited (15-DaCompany Report #AU_000501372 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Second Degree Health Diazepam C Bradycardia Professional Ferrogradumet C Solprin C Temaze C Date:07/03/00ISR Number: 3523857-5Report Type:Expedited (15-DaCompany Report #GBS000505856 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Professional Other Date:07/03/00ISR Number: 3523924-6Report Type:Expedited (15-DaCompany Report #2000-ES-00128 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Atrovent PS Boehringer Ingelheim Sudden Death Other Pharmaceuticals Inc 15 ML/NR/IH Zyprexa (Olanzapine) SS ORAL 10 MG/PO Zuclopentixol Decanoate SS INTRAMUSCULAR 200 MG/IM Zuclopentixol Acetate SS INTRAMUSCULAR 50 MG/IM Tranxilium SS ORAL PO 24-Jun-2005 12:19 PM Page: 1006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Noctamid SS ORAL 2 MG/PO Rivotril SS ORAL 1 MG/PO Clarithromycin SS ORAL 500 MG/PO Methadone SS ORAL 40 MG/PO Date:07/03/00ISR Number: 3523999-4Report Type:Expedited (15-DaCompany Report #GBS000606148 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG Health Sinemet C Professional Oxazepam C Other Date:07/03/00ISR Number: 3524000-9Report Type:Expedited (15-DaCompany Report #CA_000601614 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Foreign Zyprexa PS Eli Lilly And Co 15 MG/1 DAY 5 MON Liver Function Test Other Abnormal Date:07/03/00ISR Number: 3524003-4Report Type:Expedited (15-DaCompany Report #EWC000607060 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co Malaise Health Anafranil Pneumonia Professional (Clomipramine Sudden Death Other Hydrochloride) C Date:07/03/00ISR Number: 3524005-8Report Type:Expedited (15-DaCompany Report #GBS000606151 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 2 YR Joint Stiffness Consumer Lower Respiratory Tract Health Infection Professional Oedema Peripheral Other Weight Increased Date:07/03/00ISR Number: 3524011-3Report Type:Expedited (15-DaCompany Report #US_000338309 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperosmolar Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Coma Professional Depakote (Valproate Hyperglycaemia Sodium) C Mental Impairment Wellbutrin (Amfebutamone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/00ISR Number: 3524321-XReport Type:Expedited (15-DaCompany Report #00P-167-0091165-00(0) Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coordination Abnormal Foreign Depakene PS Abbott Laboratories Intervention to Drug Interaction Health Pharmaceutical Prevent Permanent Tremor Professional Products Div 2 GM, 1 IN 1 Impairment/Damage D Olanzapine (Olanzapine) SS 10 MG, 1 IN 1 D Bendroflumethiazide (Bendroflumethiazide ) C Atenolol (Atenolol) C Acetylsalicylic C Date:07/03/00ISR Number: 3524782-6Report Type:Expedited (15-DaCompany Report #US_000643816 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Zyprexa PS Eli Lilly And Co 10MG/ DAY White Blood Cell Count Professional Prozac SS 60MG/ DAY Decreased Tegretol C Neurontin C Date:07/06/00ISR Number: 3524609-2Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Zyprexa (Olanzapine Phosphokinase Increased )5mg PS ORAL 2 T TABS PO Hepatic Enzyme Increased HS- Lithium C Proventil C Synthroid C Synthroid C Docusate Soduim C Acetaminophen C Ibuprofen C Metamucil C Doxycline C Date:07/06/00ISR Number: 3525209-0Report Type:Direct Company Report # Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Zyprexa 10mg U/O Intervention to Dizziness (Lilly) PS Lilly ORAL 10MG PO HS Prevent Permanent Hyperhidrosis (9PM) Impairment/Damage Hypoglycaemia Zoloft C Tremor Pericolose C Weight Increased Tylenol C Maalox C Milk Of Mag C Feso4 C Glucotrol C Haldol C Cogentin C 24-Jun-2005 12:19 PM Page: 1008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525565-3Report Type:Expedited (15-DaCompany Report #S00-NOR-00923-01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Citalopram PS Forest Laboratories Initial or Prolonged Drug Interaction Health Inc ORAL 40 MG QD PO Other Stress Professional Cipramil (Citalopram Other Hydrobromide) SS ORAL TABLET QD PO Zyprexa (Olanzapine) SS ORAL 10 MG QD PO Tolvon (Mianserin Hydrochloride) SS ORAL 30 MG QD PO Tolvon (Mianserin Hydrochloride) SS Stelsolid (Diazepam) C Trimetoprim "Naf" (Trimethoprim) C Doxylin "A.L" Tablet (Doxycycline Monohydrate) C Date:07/06/00ISR Number: 3525573-2Report Type:Expedited (15-DaCompany Report #S00-USA-00749-01 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Accommodation Disorder Health Celexa PS Forest Laboratories Apathy Professional Inc ORAL 10 MG QD PO Colour Blindness Celexa (Citalopram) SS ORAL 20 MG QD PO Visual Field Defect Celexa (Citalopram SS ORAL 10 MG QD PO Seroquel SS ORAL 300 MG QD PO Zyprexa (Olanzapine) SS ORAL 2.5 MG QD PO Date:07/07/00ISR Number: 3526437-0Report Type:Expedited (15-DaCompany Report #S00-FRA-0774-01 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Citalopram PS Forest Laboratories Initial or Prolonged Increased Health Inc Liver Function Test Professional Olanzapine SS 30 MG QD Abnormal Other Prazepam SS 30 MG QD Amisulpride SS 300 MG QD Date:07/07/00ISR Number: 3526607-1Report Type:Expedited (15-DaCompany Report #00P-144-0091168-00(0) Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Tranxene Sd PS Abbott Laboratories Health Pharmaceutical Professional Products Div ORAL PER ORAL Olanzapine (Olanzapine) SS ORAL 10 MG, 1 IN 1 D, PER ORAL Zuclopenthixol Decanoate (Zuclopenthixol Decanoate) SS INTRAMUSCULAR 200 MG, 1 IN 1 D, INTRAMUSCULAR Zuclopenthixol Acetate 24-Jun-2005 12:19 PM Page: 1009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zuclopenthixol) SS INTRAMUSCULAR 50 MG, 1 IN 1 D, INTRAMUSLUCAL Lormetazepam (Lormetazepam) SS ORAL 2 MG, 1 IN 1 D, PER ORAL Clonazepam (Clonazepam) SS ORAL 1 MG, 1 IN 1 D, PER ORAL Methadone (Methadone) SS ORAL 40 MG, 1 IN 1 D, PER ORAL Clarithromycin (Clarithromycin) SS ORAL 500 MG, 1 IN 1 D, PER ORAL Ipratropium Bromide (Ipratropium Bromide) SS RESPIRATORY (INHALATION) INHALATION Date:07/10/00ISR Number: 3526752-0Report Type:Expedited (15-DaCompany Report #US_000644171 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Therapeutic Professional Cogentin Drug Toxicity Company (Benzatropine Toxicologic Test Abnormal Representative Mesilate) C Mellaril (Thioridazine Hydrochloride) C Inderal (Propranolol Hydrochloride) C Prolixin (Fluphenazine Hydrochloride) C Date:07/10/00ISR Number: 3526760-XReport Type:Expedited (15-DaCompany Report #EWC000607143 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Foreign Fluoxetine Hcl PS Lilly Research Initial or Prolonged Hypotonia Health Laboratories Div Eli Complications Of Maternal Professional Lilly And Co 40 MG/DAY Exposure To Therapeutic Other Zyprexa (Olanzapine) SS Drugs Heptaminol C Cyanosis Neonatal Tercian Neonatal Apnoeic Attack (Cyamemazine) C Neonatal Disorder Lysanxia (Prazepam) C Sedation Date:07/10/00ISR Number: 3526813-6Report Type:Expedited (15-DaCompany Report #US_000541951 Age:54 YR Gender:Male I/FU:F Outcome PT Other Blood Creatinine Increased Deep Vein Thrombosis Extrapyramidal Disorder 24-Jun-2005 12:19 PM Page: 1010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pancytopenia Renal Impairment Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co 30 MG/ 1 AT Professional BEDTIME Topamax (Topiramate) C Coumadin (Warfarin Sodium) C Cogentin (Benzatropine Mesilate) C Loxitane (Loxapine Succinate) C Vitamin D C Ativan (Lorazepam) C Restoril (Temazepam) C Multivitamin C Levofloxacin C Date:07/10/00ISR Number: 3526815-XReport Type:Expedited (15-DaCompany Report #EWC000506572 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholinergic Syndrome Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Depressed Level Of Health Xanax(Alprazolam) C Consciousness Professional Sufenta (Sufentanil Head Injury Other Citrate) C Hypertonia Morphine C Hyponatraemia Speciafoldine (Folic Injury Acid) C Road Traffic Accident Parkinane Stupor (Trihexyphenidyl Hydrochloride) C Date:07/10/00ISR Number: 3526839-2Report Type:Expedited (15-DaCompany Report #US_000644035 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa PS Eli Lilly And Co 30 MG/ 1 DAY Abnormal Professional Overdose Company Representative Date:07/10/00ISR Number: 3527453-5Report Type:Expedited (15-DaCompany Report #AU_000601468 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Intentional Misuse Health Valproate Sodium C Overdose Professional Fluvoxamine C Other 24-Jun-2005 12:19 PM Page: 1011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3527454-7Report Type:Expedited (15-DaCompany Report #CA_000201158 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Abnormal Dreams Consumer Metformin C Agitation Other Diane - 35 C Blood Pressure Decreased Orap (Pimozide) C Bradyphrenia Chlorpromazine C Confusional State Constipation Dizziness Dysphagia Dyspnoea Ear Disorder Face Oedema Fatigue Fear Feeling Cold Flushing Hair Texture Abnormal Hallucination, Auditory Headache Heart Rate Increased Hyperhidrosis Insomnia Memory Impairment Miosis Myalgia Mydriasis Nausea Nervousness Pallor Palpitations Pollakiuria Polycystic Ovaries Vision Blurred Weight Increased Date:07/10/00ISR Number: 3527455-9Report Type:Expedited (15-DaCompany Report #EWC000607128 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Jaundice Health Professional Company Representative Date:07/10/00ISR Number: 3527456-0Report Type:Expedited (15-DaCompany Report #GBS000205507 Age:27 YR Gender:Female I/FU:F Outcome PT Death Cardiac Failure Chest Pain Circulatory Collapse Coronary Artery Disease Cough Eosinophil Count Increased 24-Jun-2005 12:19 PM Page: 1012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypersensitivity Malaise Ovarian Cyst Report Source Product Role Manufacturer Route Dose Duration Ovarian Enlargement Foreign Zyprexa PS Eli Lilly And Co 10 MG Pleural Effusion Health Pleural Infection Professional Pulmonary Haemorrhage Company Skin Ulcer Representative Sudden Death Vomiting Date:07/10/00ISR Number: 3527458-4Report Type:Expedited (15-DaCompany Report #GBS000606160 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Medication Error Health Aspirin C Sedation Professional Bendrofluazide C Betahistine C Co-Codamol C Ferrous Sulphate C Dethyrone (Dextrothyroxine Sodium) C Date:07/10/00ISR Number: 3527509-7Report Type:Expedited (15-DaCompany Report #GBS000606174 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apallic Syndrome Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Initial or Prolonged Cardiac Arrest Health Prozac (Fluoxetine Disability Dehydration Professional Hydrochloride) SS Other Drug Interaction Other Droperidol C Drug Level Above Mefenamic Acid C Therapeutic Lorazepam C Electrocardiogram Qt Prolonged Date:07/10/00ISR Number: 3527523-1Report Type:Expedited (15-DaCompany Report #US_000643327 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Lorazepam C Ibuprofen C Date:07/10/00ISR Number: 3527548-6Report Type:Expedited (15-DaCompany Report #DE_000602647 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anosmia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Akineton C Professional Other 24-Jun-2005 12:19 PM Page: 1013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3527555-3Report Type:Expedited (15-DaCompany Report #DE_000602645 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Delirium Health Fluanxol C Disorientation Professional Disturbance In Attention Other Drug Level Above Therapeutic Personality Disorder Date:07/10/00ISR Number: 3527559-0Report Type:Expedited (15-DaCompany Report #DE_000602609 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 7.5 MG /1 DAY Initial or Prolonged Oedema Peripheral Health Impromen C Pain In Extremity Professional Pelvic Venous Thrombosis Other Date:07/10/00ISR Number: 3527563-2Report Type:Expedited (15-DaCompany Report #DE_000602607 Age:99 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tongue Black Hairy Foreign Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Tongue Disorder Health Atosil C Professional Lyogen - Slow Other Release (Fluphenazine Decanoate) C Date:07/10/00ISR Number: 3579916-4Report Type:Periodic Company Report #US_000541390 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Evista PS Eli Lilly And Co 10 MG/DAY 18 MON Sedation Zyprexa (Olanzapine) SS 10 MG/DAY 1 WK Effexor (Venlafaxine Hydrochloride) C Date:07/11/00ISR Number: 3527791-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000004633 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Duragesic PS Alza Corp TRANSDERMAL TRANSD Professional Sertraline (Sertraline) SS Olanzapine (Olanzapine) SS Bupropion (Amfebutamone) SS Codeine (Codeine) SS 24-Jun-2005 12:19 PM Page: 1014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/00ISR Number: 3527541-3Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Zyprexa (Olanzapine)-Lilly PS Lilly ORAL 30MG PO QHS Perphenazine 4 Mg C Milk Of Magnesia C Perphenazine 8 Mg C Acetaminophen C Maalox C Date:07/17/00ISR Number: 3529844-5Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Health Zyprexa 10mg PS ORAL 10MG PO QD Tardive Dyskinesia Professional Risperidone SS ORAL 8MG PO QD Effexor C Cogentin C Amantadine C Date:07/17/00ISR Number: 3530325-3Report Type:Direct Company Report # Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysthymic Disorder Olanzapine PS Masked Facies Date:07/17/00ISR Number: 3530346-0Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Zyprexa-Olanzapine Initial or Prolonged 20 Mgs PS ORAL 20MGS Q HS ORAL Atenolol C Docusate Sodium C Paxil And Depakote C Date:07/17/00ISR Number: 3531081-5Report Type:Expedited (15-DaCompany Report #US_000744877 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sleep Disorder Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Professional Date:07/17/00ISR Number: 3531083-9Report Type:Expedited (15-DaCompany Report #US_000744760 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Alopecia Health Clomipramine C Diabetes Mellitus Professional Pancreatitis Acute Other Serum Ferritin Increased 24-Jun-2005 12:19 PM Page: 1015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/00ISR Number: 3531085-2Report Type:Expedited (15-DaCompany Report #US_000744967 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co Professional Date:07/17/00ISR Number: 3531087-6Report Type:Expedited (15-DaCompany Report #US_000744657 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Health Zyprexa PS Eli Lilly And Co 1 MON Initial or Prolonged Thrombocytopenia Professional Proscar (Finasteride) C Tasmar (Tolcapine) C Sinemet C Eldepryl (Selegiline Hydrochloride) C Dilantin (Phenytoin Sodium) C Date:07/17/00ISR Number: 3531088-8Report Type:Expedited (15-DaCompany Report #EWC000707214 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Eosinophilia Health Tegretol Face Oedema Professional (Carbamazepine) C Pruritus Company Representative Other Date:07/17/00ISR Number: 3531089-XReport Type:Expedited (15-DaCompany Report #EWC000707211 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Eosinophilia Health Tegretol Pruritus Professional (Carbamazepine) C Company Representative Other Date:07/18/00ISR Number: 3530869-4Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Health Paroxetine PS ORAL 20 MG PO QD Initial or Prolonged Hypertension Professional Olanzepine SS ORAL 5 MG PO QD Insomnia Sedation Serotonin Syndrome Tachycardia 24-Jun-2005 12:19 PM Page: 1016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/00ISR Number: 3531148-1Report Type:Expedited (15-DaCompany Report #EWC000305906 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Anxiety Health Haldol (Haloperidol) C Drug Interaction Professional Nozinan Drug Toxicity Other (Levomepromazine) C Gastric Haemorrhage Sulfarlem (Anethole Overdose Trithione) C Panic Attack Tremor Date:07/18/00ISR Number: 3531151-1Report Type:Expedited (15-DaCompany Report #EWC000506762 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Completed Suicide Health Flurazepam C Coronary Artery Disease Professional Citalopram C Drug Level Above Other Lorazepam C Therapeutic Levothyroxine Sodium C Hepatic Steatosis Therapeutic Agent Toxicity Toxicologic Test Abnormal Date:07/18/00ISR Number: 3531154-7Report Type:Expedited (15-DaCompany Report #GBS000205507 Age:27 YR Gender:Female I/FU:F Outcome PT Death Abdominal Discomfort Atherosclerosis Cardiac Disorder Cardiac Failure Cardiomyopathy Chest Pain Circulatory Collapse Coronary Artery Disease Cough Dermatitis Drug Hypersensitivity Dry Mouth Electrolyte Imbalance Eosinophil Count Increased Fluid Overload Gastroenteritis Hepatic Congestion Influenza Injury Malaise Mineral Deficiency Ovarian Cyst Ovarian Enlargement Pleural Effusion Pleural Infection Polydipsia Pulmonary Congestion Pulmonary Haemorrhage 24-Jun-2005 12:19 PM Page: 1017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Haemosiderosis Skin Injury Skin Ulcer Report Source Product Role Manufacturer Route Dose Duration Spleen Disorder Foreign Zyprexa PS Eli Lilly And Co 10 MG Sudden Death Health Thyroid Cyst Professional Vomiting Company Weight Increased Representative Other Date:07/18/00ISR Number: 3531155-9Report Type:Expedited (15-DaCompany Report #GBS000606151 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 18 MON Cerebrovascular Accident Consumer Fall Health Joint Stiffness Professional Lower Respiratory Tract Other Infection Mood Altered Oedema Peripheral Pain In Extremity Sedation Swelling Weight Increased Date:07/18/00ISR Number: 3531157-2Report Type:Expedited (15-DaCompany Report #US_000643346 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Exfoliative Health Axid PS Eli Lilly And Co 150 MG/2 DAY 2 MON Initial or Prolonged Leukopenia Professional Zyprexa (Olanzapine) SS 20 MG/1 AT Other Neutropenia BEDTIME 2 MON Multivitamin C K-Phos Neutral C Colace (Docusate Sodium) C Simethicone C Calcium Carbonate C K-Dur (Potassium Chloride) C Clomipramine C Remeron (Mirtazapine) C Restoril (Temazepam) C Date:07/18/00ISR Number: 3531210-3Report Type:Expedited (15-DaCompany Report #AU_000401330 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Foreign Zyprexa PS Eli Lilly And Co 5MG/DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 1018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/00ISR Number: 3531212-7Report Type:Expedited (15-DaCompany Report #DE_000502446 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Carbamazepine C Professional Other Date:07/18/00ISR Number: 3531214-0Report Type:Expedited (15-DaCompany Report #US_000337022 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Hospitalization - Anuria Health BEDTIME Initial or Prolonged Apnoea Professional Albuterol C Blood Potassium Abnormal Aricept (Donepezil Cellulitis Hydrochloride) C Coma Artificial Tears C Hypotonia Aspirin Lethargy (E.C.)(Acetylsalicyl Mydriasis ic Acid) C Oedema Atrovent (Ipatropium Pallor Bromide) C Pneumonia Furosemide C Pulmonary Oedema Lanoxin (Digoxin) C Pupil Fixed Multivitamin C Renal Failure Acute Norvasc (Amlodipine Respiratory Disorder Besilate) C Insulin Novolin 70/30 C Phslo (Calcium Acetate) C Prinivil (Lisinopril) C Reguloid (Psyllium) C Trazodone C Vitamin C C Vitamin E C Zoloft (Sertraline Hydrochloride C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Ferrous Sulfate C Colace (Ducosate Sodium) C Cortisporin C Hydrocortisone C Azmacort (Triamcinolone Acetonide) C Cartia (Acetylsalicylic Acid) C Famvir (Famciclovir) C Cardizem Cd(Diltiazem Hydrochloride) C Hydralazine C 24-Jun-2005 12:19 PM Page: 1019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report K-Dur (Potassium Chloride) C Zaroxolyn(Metolazone ) C Epogen (Epoetin Alfa) C Prednisone C Prevacid (Lansoprazole) C Vicodin C Ativan (Lorazepam) C Kayexalate (Sodium Polystyrene Sulfonate) C Glucagon C Lacydrin C Date:07/18/00ISR Number: 3531217-6Report Type:Expedited (15-DaCompany Report #CA_000201158 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abnormal Dreams Agitation Anovulatory Cycle Blood Thyroid Stimulating Hormone Increased Bradyphrenia Condition Aggravated Confusional State Constipation Depression Diarrhoea Dizziness Dysphagia Dyspnoea Ear Discomfort Eyelid Oedema Face Oedema Fatigue Fear Flushing Haemoglobin Increased Hair Disorder Hair Growth Abnormal Hallucination, Auditory Headache Heart Rate Increased Hyperhidrosis Hypoglycaemia Hypotension Insomnia Memory Impairment Menstruation Irregular Miosis Myalgia Mydriasis Nausea Nervousness Pallor 24-Jun-2005 12:19 PM Page: 1020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Palpitations Peripheral Coldness Pollakiuria Report Source Product Role Manufacturer Route Dose Duration Polycystic Ovaries Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Renal Disorder Consumer Metformin C Uterine Disorder Other Diane-35 C Vision Blurred Orap (Pimozide) C Weight Increased Chlorpromazine C Date:07/18/00ISR Number: 3531266-8Report Type:Expedited (15-DaCompany Report #DE_000602609 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY Initial or Prolonged Oedema Peripheral Health Impromen Pain In Extremity Professional (Bromperidol) C Pelvic Venous Thrombosis Other Date:07/21/00ISR Number: 3533454-3Report Type:Expedited (15-DaCompany Report #2000025350FR Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Xanax PS Pharmacia And Upjohn Life-Threatening Phosphokinase Increased Health Co ORAL 0.5 MG, ORAL Blood Creatine Professional Zyprexa (Olanzapine) SS ORAL 7.5 MG, ORAL Phosphokinase Mb Other Increased Blood Creatinine Increased Coma Completed Suicide Dehydration Drug Level Above Therapeutic Hyperkalaemia Hypocalcaemia Ileus Paralytic Liver Function Test Abnormal Myoglobin Blood Increased Overdose Respiratory Disorder Date:07/24/00ISR Number: 3533634-7Report Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Zyprexa 10mg Lilly PS Lilly ORAL 10MG PO HS Pneumonia Haloperidol 5mg SS ORAL 5MG HS PO Albuterol C Folic Acid C Multivilamin C Benztropine C Gabapentin C Thiamine C Vit E C Ipratropium C Gabapentin C 24-Jun-2005 12:19 PM Page: 1021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benztropine C Docusate C Date:07/24/00ISR Number: 3534125-XReport Type:Expedited (15-DaCompany Report #DE_000602511 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Aminotransferase Health Pramipexole C Increased Professional Comtess (Entacapone) C Blood Creatine Other L-Dopa C Phosphokinase Increased Parkotil (Pergolide Blood Creatinine Mesilate) C Increased Chromaturia Rhabdomyolysis Date:07/24/00ISR Number: 3534126-1Report Type:Expedited (15-DaCompany Report #US_000337268 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Haemorrhage Consumer Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Tegretol Professional (Carbamazepine) C Date:07/24/00ISR Number: 3534127-3Report Type:Expedited (15-DaCompany Report #US_000236051 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Zyprexa PS Eli Lilly And Co 100 MG/DAY Initial or Prolonged First Degree Professional Chest Pain Hypotension Intentional Misuse Palpitations Suicide Attempt Tachycardia Date:07/24/00ISR Number: 3534128-5Report Type:Expedited (15-DaCompany Report #US_000541402 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Cardiomegaly Professional Lorazepam C Hypertension Company Amoxicillin C Sinusitis Representative Acetaminophen C Ventricular Hypertrophy Robitussin (Guaifenesin) C Date:07/24/00ISR Number: 3534359-4Report Type:Expedited (15-DaCompany Report #US_000745445 Age:19 YR Gender:Male I/FU:I Outcome PT Erythropenia Haematocrit Decreased Haemoglobin Decreased 24-Jun-2005 12:19 PM Page: 1022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukopenia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY 8 DAY Professional Lithium C Date:07/24/00ISR Number: 3534361-2Report Type:Expedited (15-DaCompany Report #US_000745547 Age:11 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Exposure To Therapeutic Consumer Kawakawa C Drugs Health Passiflora C Cough Professional Dyspnoea Other Date:07/24/00ISR Number: 3534363-6Report Type:Expedited (15-DaCompany Report #US_000745171 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Zyprexa PS Eli Lilly And Co 20 MG/ 1 DAY Galactorrhoea Professional Loxitane (Loxapine Pituitary Tumour Benign Company Succinate) C Representative Date:07/24/00ISR Number: 3534367-3Report Type:Expedited (15-DaCompany Report #US_000744983 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 15 MG/ 1DAY Hospitalization - Dizziness Professional Initial or Prolonged Hyperglycaemia Company Vomiting Representative Date:07/24/00ISR Number: 3534369-7Report Type:Expedited (15-DaCompany Report #GBS000706264 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Health Thyroxine C Professional Other Date:07/24/00ISR Number: 3534371-5Report Type:Expedited (15-DaCompany Report #DE_000702717 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Therapeutic Health Tavor (Lorazepam) C Intentional Misuse Professional Truxal Suicidal Ideation Other (Chlorprothixene Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/00ISR Number: 3534373-9Report Type:Expedited (15-DaCompany Report #EWC000707337 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa PS Eli Lilly And Co 15MG/DAY Corrected Interval Health Cetirizine Prolonged Professional Hydrochloride C Company Surmontil Representative (Trimipramine) C Other Seresta Forte (Oxazepam) C Livostin (Levocabastine Hydrochloride) C Irgamid (Sulfadicramide) C Importal (Lactitol) C Date:07/24/00ISR Number: 3534375-2Report Type:Expedited (15-DaCompany Report #GBS000706250 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Peritonitis Health Enalapril C Professional Bumetanide C Other Brufen (Ibuprofen) C Digoxin C Date:07/24/00ISR Number: 3534629-XReport Type:Expedited (15-DaCompany Report #US_000744882 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Bicarbonate Foreign Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Hospitalization - Increased Literature Initial or Prolonged Blood Glucose Increased Health Blood Ph Decreased Professional Coma Confusional State Dyspnoea Pco2 Increased Respiratory Acidosis Respiratory Failure Sedation Date:07/24/00ISR Number: 3534769-5Report Type:Expedited (15-DaCompany Report #EWC000707313 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 1024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/00ISR Number: 3534771-3Report Type:Expedited (15-DaCompany Report #EWC000707334 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Health Professional Other Date:07/24/00ISR Number: 3534774-9Report Type:Expedited (15-DaCompany Report #US_000745377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS Eli Lilly And Co 30 MG/AT Professional BEDTIME Acetaminophen C Maalox C Milk Of Magnesia C Date:07/24/00ISR Number: 3534787-7Report Type:Expedited (15-DaCompany Report #DE_000602645 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Disorientation Health Fluanxol C Disturbance In Attention Professional Drug Level Above Other Therapeutic Personality Disorder Restlessness Date:07/24/00ISR Number: 3535472-8Report Type:Periodic Company Report #20315-029 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Orlaam PS Roxane Laboratories Initial or Prolonged Dyspnoea Professional Inc ORAL 70 MG MWF, PO 2 MON Zyprexa SS Eli Lilly & Co. ORAL 5MG BID, PO Date:07/27/00ISR Number: 3535659-4Report Type:Direct Company Report # Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Zyprexa 20mg, 10mg, 15mg, Eli Lilly PS Eli Lilly ORAL QD PO Lithium Carbonate C Restoril C Serox C Date:07/27/00ISR Number: 3536469-4Report Type:Expedited (15-DaCompany Report #ENT00180 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Blood Cholesterol Initial or Prolonged Increased Blood Creatine Phosphokinase Increased 24-Jun-2005 12:19 PM Page: 1025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Creatine Phosphokinase Mb Increased Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Comtan PS Orion Corp ORAL 800 MG P.O. 3 WK Increased Professional Zyprexa Olanzapine SS ORAL 5 MG P.O. 3 WK Chromaturia Levodopa C Drug Interaction Parkotil Pergolide C Haematuria Sifrol Pramipexole C Liver Function Test Abnormal Rhabdomyolysis Date:07/28/00ISR Number: 3537787-6Report Type:Expedited (15-DaCompany Report #PHBS1999AU04725 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Left Ventricular Failure Health Pharmaceuticals Corp ORAL 75 MG MANE & Mental Impairment Professional 100 MG Orthostatic Hypotension Other NOCTE/DAY, Psychotic Disorder ORAL Pyrexia Olanzapine Tachycardia (Olanzapine) SS 5 MG, QD Sodium Valproate (Valproate Sodium) C Ranitidine (Ranitidine) C Date:07/31/00ISR Number: 3538234-0Report Type:Expedited (15-DaCompany Report #US_000643346 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Axid PS Eli Lilly And Co 150 MG/2 DAY 2 MON Neutropenia Professional Zyprexa (Olanzapine) SS 20 MG 1 AT BEDIME 2 MON Multivitamin C K-Phos Neutral C Colace (Docusate Sodium) C Simethicone C Calcium Carbonate C K-Dur (Potassium Chloride) C Clomipramine C Remeron (Mirtazapine) C Restoril (Temazepam) C Date:07/31/00ISR Number: 3538287-XReport Type:Expedited (15-DaCompany Report #US_000438693 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Consumer Zyprexa PS Eli Lilly And Co 30 MG /DAY 4 MON Health Prevacid Professional (Lansoprazole) C 24-Jun-2005 12:19 PM Page: 1026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/00ISR Number: 3538377-1Report Type:Expedited (15-DaCompany Report #US_000745719 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Psychotic Disorder Professional Prozac (Fluoxetine Company Hydrchloride) SS Representative Tofranil (Imipramine Hydrochloride) C Date:07/31/00ISR Number: 3538379-5Report Type:Expedited (15-DaCompany Report #US_000745687 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa PS Eli Lilly And Co 10 MG/AT Initial or Prolonged Health BEDTIME 6 MON Professional Paxil(Paroxetine Hydrochloride) C Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Date:07/31/00ISR Number: 3538386-2Report Type:Expedited (15-DaCompany Report #EWC000707335 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Sinemet C Professional Company Representative Other Date:07/31/00ISR Number: 3538388-6Report Type:Expedited (15-DaCompany Report #EWC000707368 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Foreign Zyprexa PS Eli Lilly And Co 300 MG/DAY 6 MON Hospitalization - Overdose Health Initial or Prolonged Respiratory Failure Professional Syncope Other Date:07/31/00ISR Number: 3538394-1Report Type:Expedited (15-DaCompany Report #US_000745696 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apgar Score Low Consumer Zyprexa PS Eli Lilly And Co TRANSPLACENTAL Other Complications Of Maternal Health Paxil (Paroxetine Exposure To Therapeutic Professional Hydrochloride) C Drugs Depakote (Valproate Lethargy Semisodium) C Neonatal Apnoeic Attack Haldol (Haloperidol) C Neonatal Respiratory Marijuana C Arrest 24-Jun-2005 12:19 PM Page: 1027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/00ISR Number: 3538399-0Report Type:Expedited (15-DaCompany Report #US_000745510 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Haematemesis Health Lasix (Furosemide) C Haematocrit Decreased Professional Aspirin C Haemoglobin Decreased Norvac (Amlodipine Hiatus Hernia Besilate) C Red Blood Cell Count K-Dur (Potassium Decreased Chloride) C Upper Gastrointestinal Glucotrol Haemorrhage (Glipizide) C Vomiting Cardura (Doxazosin Mesilate) C Imodium (Loperamide Hydrochloride) C Date:07/31/00ISR Number: 3538422-3Report Type:Expedited (15-DaCompany Report #US_000745448 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Fluoxetine Hcl PS Lilly Research Blood Potassium Decreased Professional Laboratories Div Eli Circulatory Collapse Lilly And Co 80 MG PER DAY Completed Suicide Zyprexa (Olanzapine) SS 7.5 MG/DAY Drug Level Above Gabapentin C Therapeutic Drug Toxicity Date:07/31/00ISR Number: 3538436-3Report Type:Expedited (15-DaCompany Report #US_000744657 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Thrombocytopenia Professional Proscar C Tasmar C Sinemet C Edlepryl C Dilantin C Prilosec C Ditropan C Date:07/31/00ISR Number: 3538439-9Report Type:Expedited (15-DaCompany Report #US_000745449 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Professional Lithium C Company Representative Date:07/31/00ISR Number: 3538441-7Report Type:Expedited (15-DaCompany Report #GBS000706281 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Death Overdose Foreign Health 24-Jun-2005 12:19 PM Page: 1028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Fluoxetine (Fluoxetine Hydrochloride) SS Carbamazepine C Date:07/31/00ISR Number: 3538444-2Report Type:Expedited (15-DaCompany Report #EWC000707389 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paralysis Foreign Zyprexa PS Eli Lilly And Co 30 MG DAY Health Lepticur C Professional Rivotril C Other Depamide (Valpromide) C Imovane (Zopiclone) C Theralene (Alimemazine Tartrate) C Date:07/31/00ISR Number: 3538446-6Report Type:Expedited (15-DaCompany Report #EWC000707371 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Iron Deficiency Anaemia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Company Representative Other Date:08/02/00ISR Number: 3539738-7Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Olanzapine PS 7 MON Deep Vein Thrombosis Hctz C Obesity Pulmonary Embolism Weight Increased Date:08/02/00ISR Number: 3540526-6Report Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oedema Peripheral Zyprexa 10 Mg Intervention to Lilly PS Lilly ORAL 10 MG QHS Prevent Permanent ORAL Impairment/Damage 24-Jun-2005 12:19 PM Page: 1029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/00ISR Number: 3545303-8Report Type:Expedited (15-DaCompany Report #DE_000702717 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Drug Level Above Health Tavor (Lorazepam) C Therapeutic Professional Truxal Overdose Other (Chlorprothixene Psychotic Disorder Hydrochloride) C Date:08/08/00ISR Number: 3545304-XReport Type:Expedited (15-DaCompany Report #US_990116735 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Literature Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Depression Health Elavil Ecchymosis Professional (Amitriptyline Hallucination Hydrochloride) C Insomnia Thrombocytopenia Date:08/08/00ISR Number: 3545306-3Report Type:Expedited (15-DaCompany Report #US_000643175 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Hospitalization - Blood Creatinine Professional Doxepin C Initial or Prolonged Increased Metoprolol C Disability Coma Lasix (Furosemide) C Convulsion Kcl-Retard(Potassium Encephalopathy Chloride) C Glomerulonephritis Tylenol Haemodialysis (Paracetamol) C Mental Impairment Albuterol C Nausea Kefzol (Cefazolin Oedema Sodium) C Renal Failure Acute Depakote (Valproate Renal Impairment Semisodium) C Respiratory Failure Ibuprofen C Sedation Loxitane (Loxapine Sepsis Succinate) C Staphylococcal Infection Risperdal Vomiting (Risperidone) C Date:08/08/00ISR Number: 3545354-3Report Type:Expedited (15-DaCompany Report #US_000746120 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Humulin R PS Eli Lilly And Co 41 U/DAY 1 YR Cerebrovascular Accident Zyprexa SS Depersonalisation Feeling Abnormal Retinal Disorder 24-Jun-2005 12:19 PM Page: 1030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/00ISR Number: 3545468-8Report Type:Expedited (15-DaCompany Report #US_000643180 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Renal Impairment Professional Carbamazepine C Sedation Gemfibrozil C Vomiting Nicotine Dermal Patch (Nicotine Resin) C Lomotil C Lorazepam C Cortisporin Ophthalmic Suspension C Estradiol C Date:08/08/00ISR Number: 3545469-XReport Type:Expedited (15-DaCompany Report #US_000643547 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Diverticulitis Intestinal Health Sertraline C Haemorrhagic Professional Donepezil C Haematochezia Vitamin E C Haematocrit Decreased Aspirin C Haemoglobin Decreased Iron C Rectal Haemorrhage Dulcolax (Bisacodyl) C Red Blood Cell Count Bisacodyl C Decreased Date:08/08/00ISR Number: 3545471-8Report Type:Expedited (15-DaCompany Report #US_000745510 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Haematemesis Health Lasix (Furosemide) C Haematocrit Decreased Professional Aspirin C Haemoglobin Decreased Norvasc (Amlodipine Hiatus Hernia Besilate) C Irritable Bowel Syndrome K-Dur (Potassium Nausea Chloride) C Red Blood Cell Count Glucotrol Decreased (Glipizide) C Upper Gastrointestinal Cardura (Doxazosin Haemorrhage Mesilate) C Vomiting Imodium (Loperamide Hydrochloride) C Date:08/08/00ISR Number: 3545514-1Report Type:Expedited (15-DaCompany Report #EWC000707451 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Zyprexa PS Eli Lilly And Co 700MG/DAY Initial or Prolonged Overdose Health Respiratory Disorder Professional Suicide Attempt Company Representative Other 24-Jun-2005 12:19 PM Page: 1031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/00ISR Number: 3545517-7Report Type:Expedited (15-DaCompany Report #GBS000706349 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS Eli Lilly And Co 45 MG/DAY Initial or Prolonged Overdose Health Haloperidol C Professional Losec C Other Ventolin(Salbutamol) C Vitamin C Date:08/08/00ISR Number: 3545519-0Report Type:Expedited (15-DaCompany Report #US_000746053 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombotic Health Zyprexa PS Eli Lilly And Co 5 MG/1 AT Initial or Prolonged Thrombocytopenic Purpura Professional BEDTIME 4 MON Paxil(Paroxetine Hydrochloride) C Date:08/08/00ISR Number: 3545521-9Report Type:Expedited (15-DaCompany Report #US_000745873 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Agitation Professional Asthenia Company Blood Creatine Representative Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Cognitive Disorder Confusional State Delusion Dementia Hallucination Hypoglycaemia Loose Associations Oral Intake Reduced Pyrexia Red Blood Cell Sedimentation Rate Increased Schizophrenia Sleep Disorder Suicidal Ideation Tachycardia Date:08/08/00ISR Number: 3545524-4Report Type:Expedited (15-DaCompany Report #US_000746114 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Angioplasty Health Luvox C Arteriosclerosis Professional Relafen C Inflammation Clonazepam C Tardive Dyskinesia 24-Jun-2005 12:19 PM Page: 1032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/00ISR Number: 3545611-0Report Type:Expedited (15-DaCompany Report #AU_000701672 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/ IN THE Initial or Prolonged Health MORNING Professional Olanzapine SS 20 MG/AT Other BEDTIME Valproate Sodium C Date:08/08/00ISR Number: 3545612-2Report Type:Expedited (15-DaCompany Report #EWC000707416 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Fall Health Tercian Malaise Professional (Cyamemazine) C Sudden Death Company Rohypnol Representative (Flunitrazepam) C Date:08/08/00ISR Number: 3545613-4Report Type:Expedited (15-DaCompany Report #EWC000707418 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Other Status Epilepticus Health Tercian Professional (Cyamemazine) C Company Representative Date:08/08/00ISR Number: 3545614-6Report Type:Expedited (15-DaCompany Report #EWC000707435 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Health Professional Other Date:08/11/00ISR Number: 3548900-9Report Type:Expedited (15-DaCompany Report #A027490 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Vistaril PS Pfizer Laboratories Initial or Prolonged Pyrexia Consumer Div Pfizer Inc ORAL 125.00 MG Spinal Myelogram Abnormal TOTAL: DAILY :ORAL Olanzapine SS ORAL DAILY:ORAL Cyamemazine SS ORAL 200.00 MG TOTAL:DAILY: ORAL 24-Jun-2005 12:19 PM Page: 1033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/00ISR Number: 3549190-3Report Type:Expedited (15-DaCompany Report #00GB-10589 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Tegretol PS Novartis Other Health Pharmaceuticals Corp DAILY Professional Fluoxetine Unknown Other (Fluoxetine) SS Zyprexa Unknown (Olanzapine) SS ORAL ORAL Date:08/14/00ISR Number: 3550455-XReport Type:Expedited (15-DaCompany Report #US_000746190 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Consciousness Tegretol Dizziness (Carbamazepine) C Dysarthria Blood Pressure Headache Medication C Date:08/14/00ISR Number: 3550456-1Report Type:Expedited (15-DaCompany Report #US_000846485 Age:24 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abdominal Pain Consumer Zyprexa PS Eli Lilly And Co Bruxism Prozac (Fluoxetine Complications Of Maternal Hydrochloride) SS Exposure To Therapeutic Nortriptyline C Drugs Microcephaly Date:08/14/00ISR Number: 3550457-3Report Type:Expedited (15-DaCompany Report #US_000643907 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Zyprexa PS Eli Lilly And Co Professional Date:08/14/00ISR Number: 3550579-7Report Type:Expedited (15-DaCompany Report #DE_000502386 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY 3 WK Initial or Prolonged Cardiogenic Shock Health Isoptin C Hyperglycaemia Professional Aspirin C Hypotension Distraneurin C Pco2 Decreased Skin Discolouration Date:08/14/00ISR Number: 3550581-5Report Type:Expedited (15-DaCompany Report #EWC000506821 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Death Cardiac Arrest Foreign Status Epilepticus Health Professional 24-Jun-2005 12:19 PM Page: 1034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 20 MG/DAY Terican C Noriel C Date:08/14/00ISR Number: 3550583-9Report Type:Expedited (15-DaCompany Report #US_000542341 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Eli Lilly And Co Intentional Misuse Professional Date:08/14/00ISR Number: 3550690-0Report Type:Expedited (15-DaCompany Report #A010796 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Consumer Navane PS Roerig Div Pfizer Intervention to Dry Mouth Inc Prevent Permanent Dysuria Stelazine SS Impairment/Damage Neurogenic Bladder Seroquel SS Nightmare Olanzapine SS Tardive Dyskinesia Urinary Retention Date:08/14/00ISR Number: 3550703-6Report Type:Expedited (15-DaCompany Report #US_000846646 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Fluoxetine Hcl PS Lilly Research Therapeutic Professional Laboratories Div Eli Overdose Lilly And Co Zyprexa (Olanzapine) SS Gabapentin C Date:08/14/00ISR Number: 3550728-0Report Type:Expedited (15-DaCompany Report #DE_000802809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 3 MON Health Professional Other Date:08/14/00ISR Number: 3550730-9Report Type:Expedited (15-DaCompany Report #US_000846498 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Foreign Zyprexa PS Eli Lilly And Co SUBLINGUAL 2 YR Leukopenia Literature Neutropenia Health Upper Respiratory Tract Professional Infection Other 24-Jun-2005 12:19 PM Page: 1035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/00ISR Number: 3550732-2Report Type:Expedited (15-DaCompany Report #US_000846385 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Phosphokinase Increased Literature Liver Function Test Health Abnormal Professional Neutropenia Other Psychotic Disorder Date:08/14/00ISR Number: 3550733-4Report Type:Expedited (15-DaCompany Report #CA_000801782 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Pancreatitis Health Octreotide C Professional Ms Contin (Morphine Other Sulfate) C Temazepam C Date:08/14/00ISR Number: 3550738-3Report Type:Expedited (15-DaCompany Report #DE_000602576 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Menstrual Disorder Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Ovarian Cancer Health Contraceptivum E C Ovarian Cyst Professional Other Date:08/14/00ISR Number: 3550739-5Report Type:Expedited (15-DaCompany Report #US_000746153 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Date:08/15/00ISR Number: 3551011-XReport Type:Expedited (15-DaCompany Report #242293 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Clonopin PS Hoffmann La Roche Other Inc ORAL .5 MG DAILY ORAL Zyprexa (Olanzapine) 10 Mg SS ORAL 20 MG DAILY ORAL Metadona (Methadone Hydrochloride) SS ORAL 50 MG DAILY ORAL Date:08/17/00ISR Number: 3552183-3Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Hyporeflexia Initial or Prolonged Intentional Misuse Lethargy 24-Jun-2005 12:19 PM Page: 1036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS Clonazepam SS Diphenhydramine SS Date:08/18/00ISR Number: 3552305-4Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Olanzapine 10mg Tabs Eli-Lilly PS Eli-Lilly ORAL 10MG Q HS ORAL Lithium C Date:08/18/00ISR Number: 3553087-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Olanzapine PS 15 MG AT Second Degree BEDTIME Date:08/18/00ISR Number: 3553088-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Olanzapine PS 10 MG 6 MON First Degree Professional Ventricular Hypertrophy Date:08/18/00ISR Number: 3589007-4Report Type:Periodic Company Report #S99-USA-02348-01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Celexa PS Forest Laboratories Blood Prolactin Increased Professional Inc ORAL 20 MG QD PO Depression Company Celexa (Citalopram) SS 20 MG QD PO Diarrhoea Representative Risperdal Muscle Twitching (Risperidone) SS Paranoia Zyprexa (Olanzapine) SS ORAL 2.5 MG PRN PO Sedation Caffeine SS Sinusitis Lithium Carbonate C Ambien (Zolpidem Tartrate) C Date:08/21/00ISR Number: 3554654-2Report Type:Expedited (15-DaCompany Report #A0125734A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Health Wellbutrin PS Glaxo Wellcome Inc Cardiac Disorder Professional Olanzapine Depressed Level Of Company (Formulation Consciousness Representative Unknown) Hypotension (Olanzapine) SS Overdose 24-Jun-2005 12:19 PM Page: 1037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/00ISR Number: 3554932-7Report Type:Expedited (15-DaCompany Report #JACGER2000001352 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Second Degree Health Div Johnson And Cardiac Arrest Professional Johnson ORAL MG, DAILY, Sinus Arrest ORAL Haldol (Haloperidol) SS ORAL DAILY, ORAL Zyprexa (Olanzapine) SS ORAL DAILY, ORAL Eunerpan (Melperone Hydrochloride) SS ORAL MG, DAILY, ORAL Date:08/22/00ISR Number: 3554808-5Report Type:Direct Company Report # Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Zyprexa PS Hospitalization - Difficulty In Walking Other Antipsychotic SS Initial or Prolonged Inappropriate Disability Antidiuretic Hormone Required Secretion Intervention to Mental Impairment Prevent Permanent Tremor Impairment/Damage Date:08/22/00ISR Number: 3555291-6Report Type:Expedited (15-DaCompany Report #JACGER2000001352 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Haldol PS Rw Johnson Initial or Prolonged Sinus Arrest Health Pharmaceutical Professional Research Institute Div Ortho Pharm ORAL DAILY ORAL Risperdal (Tablet) (Risperidone) SS ORAL DAILY, ORAL Zyprexa (Olanzapine) SS ORAL DAILY, ORAL Eunerpan (Melperone Hydrochloride0 SS ORAL DAILY, ORAL Date:08/22/00ISR Number: 3555511-8Report Type:Expedited (15-DaCompany Report #US_000846646 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Fluoxetine Hcl PS Lilly Research Therapeutic Professional Laboratories Div Eli Overdose Lilly And Co Zyprexa (Olanzapine) SS Gabapentin C Date:08/22/00ISR Number: 3555535-0Report Type:Expedited (15-DaCompany Report #EWC000707334 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Hospitalization - Leukopenia Foreign Initial or Prolonged Neutropenia Health 24-Jun-2005 12:19 PM Page: 1038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5 MG/DAILY Date:08/22/00ISR Number: 3555538-6Report Type:Expedited (15-DaCompany Report #EWC000707214 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Eosinophilia Health Tegretol(Carbamazepi Face Oedema Professional ne) C Pharyngitis Company Solian(Amisulpride) C Representative Imovane(Zopiclone) C Other Date:08/22/00ISR Number: 3555541-6Report Type:Expedited (15-DaCompany Report #US_000643547 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Hospitalization - Haematochezia Health Sertraline C Initial or Prolonged Haematocrit Decreased Professional Donepezil C Haemoglobin Decreased Vitamin E C Hypotension Aspirin C Rectal Haemorrhage Iron C Red Blood Cell Count Dulcolax(Bisacodyl) C Decreased Bisacodyl C Date:08/22/00ISR Number: 3555543-XReport Type:Expedited (15-DaCompany Report #EWC000707435 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Health Professional Other Date:08/22/00ISR Number: 3555544-1Report Type:Expedited (15-DaCompany Report #DE_000602609 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY Initial or Prolonged Pain In Extremity Health Imopromen Pelvic Venous Thrombosis Professional (Bromperidol) C Other Date:08/22/00ISR Number: 3555546-5Report Type:Expedited (15-DaCompany Report #US_000643261 Age:39 YR Gender:Female I/FU:F Outcome PT Death Bite Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Brain Oedema Coma 24-Jun-2005 12:19 PM Page: 1039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Dermal Cyst Fatigue Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Hyperpyrexia Professional Eskalith Cr(Lithium Hypothalamo-Pituitary Carbonate) C Disorders Mania Medication Error Necrosis Pulse Pressure Decreased Sluggishness Weight Increased Date:08/22/00ISR Number: 3555719-1Report Type:Expedited (15-DaCompany Report #EWC000807565 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Iron Deficiency Anaemia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Laroxyl Professional (Amitriptyline Other Hydrochloride) C Lepticur (Tropatepine Hydrochloride) C Theralene (Alimemeazine Tartrate) C Rivotril (Clonazepam) C Seresta (Oxazepam) C Date:08/22/00ISR Number: 3555720-8Report Type:Expedited (15-DaCompany Report #EWC000807561 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Pyrexia Health Atarax (Hydroxyzine Spinal Myelogram Abnormal Professional Hydrochloride) C Other Tercian (Cyamemazine) C Date:08/22/00ISR Number: 3555721-XReport Type:Expedited (15-DaCompany Report #DE_000802838 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Diabetic Coma Health Lithium C Hyperglycaemia Professional Renal Failure Acute Other Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 1040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/22/00ISR Number: 3555722-1Report Type:Expedited (15-DaCompany Report #GBS000806412 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Life Support Foreign Zyprexa PS Eli Lilly And Co 400MG/DAY Initial or Prolonged Overdose Health Professional Company Representative Other Date:08/22/00ISR Number: 3555723-3Report Type:Expedited (15-DaCompany Report #US_000846873 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Haemolytic Anaemia Professional Prilosec (Omeprazole) C Date:08/22/00ISR Number: 3555724-5Report Type:Expedited (15-DaCompany Report #GBS000806392 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomania Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY Initial or Prolonged Health Paroxetine C Professional Venlafaxien C Other Thioridazine C Date:08/22/00ISR Number: 3555728-2Report Type:Expedited (15-DaCompany Report #EWC000807564 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Foreign Lithium PS 900 MG/DAY Initial or Prolonged Bundle Branch Block Right Study Olanzapine SS 20 MG/DAY Other Dyspnoea Health Lorazepam C Haematocrit Decreased Professional Haemoglobin Decreased Other Mean Cell Volume Decreased Microcytic Anaemia Date:08/22/00ISR Number: 3555730-0Report Type:Expedited (15-DaCompany Report #AU_000801765 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Rhinitis Health Metformin C Professional Other Date:08/22/00ISR Number: 3555731-2Report Type:Expedited (15-DaCompany Report #US_000846890 Age:83 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Dizziness Fatigue 24-Jun-2005 12:19 PM Page: 1041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastritis Haematocrit Decreased Haemoglobin Decreased Report Source Product Role Manufacturer Route Dose Duration Sedation Study Zyprexa PS Eli Lilly And Co 2.5 MG / AT Health BEDTIME Professional Pepcid (Famotidine) C Amaryl (Glimepiride) C Atenolol C Cordarone (Amiodarone Hydrochloride) C Furosemide C Evista (Raloxifene Hydrochloride) C Synthroid (Levothyroxine Sodium) C Prinivil (Lisinopril) C K-Dur (Potassium Chloride) C Date:08/22/00ISR Number: 3555732-4Report Type:Expedited (15-DaCompany Report #US_000542527 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Zyprexa PS Eli Lilly And Co 12.5 MG / 1 Hospitalization - Hypokalaemia Health AT BEDTIME Initial or Prolonged Professional Depakote (Valproate Semisodium) C Analgesics C Date:08/22/00ISR Number: 3555764-6Report Type:Expedited (15-DaCompany Report #242430 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Iron Deficiency Anaemia Foreign Clonopin PS Hoffmann La Roche Initial or Prolonged Other Inc ORAL 80 DOSE FORM DAILY ORAL Laroxy Gouttes (Amitriptyline Hydrochloride) SS ORAL 100 DOSE FORM DAILY ORAL Lepticur (Tropatepine) SS ORAL 2 DOSE FORM DAILY ORAL Seresta (Oxazepam) SS ORAL 4 DOSE FORM DAILY ORAL Theralene (Trimeprazine Tartrate) SS ORAL 120 DOSE FORM DAILY ORAL Zyprexa (Olanzapine) SS ORAL 10 MG DAILY ORAL Treatment Not Known C 24-Jun-2005 12:19 PM Page: 1042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/00ISR Number: 3556194-3Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Amitriptyline PS Initial or Prolonged Aphasia Olanzapine SS Drug Interaction Dyspnoea Hyperhidrosis Hypertension Mental Impairment Neuroleptic Malignant Syndrome Pyrexia Salivary Hypersecretion Serotonin Syndrome Sinus Tachycardia Urinary Incontinence Vomiting Date:08/23/00ISR Number: 3556615-6Report Type:Expedited (15-DaCompany Report #HQ9883015AUG2000 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Study Tavor (Lorazepam) PS Wyeth Ayerst Lipase Increased Laboratories Inc ORAL 3 MG 1X PER 1 Liver Function Test DAY ORAL 8 DAY Abnormal Eunerpan (Melperone Hydrochloride) SS ORAL ORAL 11 DAY Zyprexa (Olanzapine) SS ORAL 20 MG 1X PER 1 DAY ORAL Date:08/24/00ISR Number: 3557738-8Report Type:Expedited (15-DaCompany Report #A0124755A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Health Wellbutrin PS Glaxo Wellcome Inc ORAL 200 MG TWICE Hospitalization - Convulsion Professional PER DAY ORAL Initial or Prolonged Insomnia Venlafaxine Intentional Misuse Hydrochloride Loss Of Consciousness (Formulation Suicide Attempt Unknown) Tympanic Membrane (Venlafaxine SS AT NIGHT Perforation Olanzapine Weight Increased (Formulation Unknown) (Olanzapine) SS Ibuprofen (Formulation Unknown) (Ibuprofen) SS Percocet C Date:08/24/00ISR Number: 3566371-3Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Blood Thyroid Stimulating Hormone Increased Condition Aggravated 24-Jun-2005 12:19 PM Page: 1043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypercholesterolaemia Hypertriglyceridaemia Report Source Product Role Manufacturer Route Dose Duration Health Lithium PS ORAL 600 MG PO BID Professional Thorazine SS ORAL 200 MG PO QID Depakote SS ORAL 500 MG PO BID Seroquel SS ORAL 200 MG PO BID Depakote SS ORAL 250-750 MG PO Zyprexa SS ORAL 5MG PO HS Ritalin SS 20 MG PO TID Tenex C Date:08/28/00ISR Number: 3559627-1Report Type:Direct Company Report # Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Zyprexa PS Coordination Abnormal Seroquel SS Dyscalculia Paxil SS Hyperglycaemia Major Depression Mood Disorder Due To A General Medical Condition Movement Disorder Psychotic Disorder Tremor Date:08/28/00ISR Number: 3560520-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000001974 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Literature Risperdal PS Janssen Research Fdn Exposure To Therapeutic Health Div Johnson And Drugs Professional Johnson Intra-Uterine Death Olanzapine (Olanzapine) SS Date:08/28/00ISR Number: 3560749-XReport Type:Expedited (15-DaCompany Report #D0009760A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematoma Foreign Zantac 150 PS Glaxo Wellcome Inc ORAL ORAL Initial or Prolonged Haemorrhage Olanzapine Petechiae (Olanzapine) SS ORAL ORAL Thrombocytopenia Mirtazapine (Mirtazapine) SS ORAL ORAL Date:08/29/00ISR Number: 3561331-0Report Type:Expedited (15-DaCompany Report #US_000847246 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Other 24-Jun-2005 12:19 PM Page: 1044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/00ISR Number: 3561642-9Report Type:Expedited (15-DaCompany Report #JACGER2000001371 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Haldol PS Rw Johnson Initial or Prolonged Phosphokinase Increased Health Pharmaceutical Blood Creatine Professional Research Institute Phosphokinase Mb Div Ortho Pharm ORAL DAILY, ORAL Increased Dipioeron Blood Lactate (Unspecified) Dehydrogenase Increased (Pipamperone) SS ORAL DAILY, ORAL Rhabdomyolysis Akineton (Biperiden Hydrochloride) SS ORAL DAILY, ORAL Zyprexa (Olanzapine) SS ORAL DAILY, ORAL Date:08/29/00ISR Number: 3561678-8Report Type:Expedited (15-DaCompany Report #S00-NLD-01285-01 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Celexa PS Forest Laboratories Hepatic Failure Health Inc ORAL 60 MG, QD, PO Hepatitis Professional Olanzapine SS ORAL 5 MG, QD, PO Jaundice Liver Function Test Abnormal Date:08/29/00ISR Number: 3561792-7Report Type:Expedited (15-DaCompany Report #EWC000807564 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Foreign Lithium PS UNKNOWN 900 MG DAY Initial or Prolonged Bundle Branch Block Right Study UNKNOWN Other Dyspnoea Health Olanzapine SS UNKNOWN 20 MG DAY Haematocrit Decreased Professional UNKNOWN Mean Cell Volume Abnormal Other Lorazepam C Microcytic Anaemia Pulmonary Embolism Date:08/29/00ISR Number: 3561799-XReport Type:Expedited (15-DaCompany Report #DE_000602607 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tongue Black Hairy Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 20 MG 1 DAY Initial or Prolonged Tongue Disorder Health UNKNOWN Professional Atosil (Isopromethazine Hydrochloride) C Lyogen - Slow Release (Fluphenazine Decanoate) C Date:08/29/00ISR Number: 3561802-7Report Type:Expedited (15-DaCompany Report #GBS000806412 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Overdose Foreign Initial or Prolonged Respiratory Depression Health 24-Jun-2005 12:19 PM Page: 1045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co UNKNOWN 400 MG DAY UNKNOWN Date:08/29/00ISR Number: 3561807-6Report Type:Expedited (15-DaCompany Report #US_000744760 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 10 MG 1 Initial or Prolonged Alopecia Health UNKNOWN Blood Cholesterol Professional Clomipramine C Increased Other Glucose, Fasting C Blood Triglycerides Increased Diabetes Mellitus Glycosylated Haemoglobin Decreased High Density Lipoprotein Decreased Low Density Lipoprotein Increased Pancreatitis Acute Psychotic Disorder Serum Ferritin Increased Date:08/29/00ISR Number: 3561820-9Report Type:Expedited (15-DaCompany Report #US_000846890 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG/AT Initial or Prolonged Asthenia Health BEDTIME Faecal Occult Blood Professional Pepcid (Famotidine) C Positive Amaryl (Glimepiride) C Gastritis Atenolol C Haematocrit Decreased Cordarone Haemoglobin Decreased (Amiodarone Lethargy Hydrochloride) C Rectal Haemorrhage Furosemide C Evista (Raloxifene Hydrochloride) C Synthroid (Levothyroxine Sodium) C Prinivil (Lisinopril) C K-Dur (Potassium Chloride) C Date:08/29/00ISR Number: 3561915-XReport Type:Expedited (15-DaCompany Report #US_000847251 Age:15 YR Gender:Female I/FU:I Outcome PT Other Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Hallucination 24-Jun-2005 12:19 PM Page: 1046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatitis C Report Source Product Role Manufacturer Route Dose Duration Health Fluoxetine Hcl PS Lilly Research Professional Laboratories Div Eli Company Lilly And Co 20 MG/1 DAY Representative Zyprexa (Olanzapine) SS 2.5 MG/1 DAY Paxil (Paroxetine Hydrochloride) C Date:08/29/00ISR Number: 3561923-9Report Type:Expedited (15-DaCompany Report #US_000847352 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspiration Health Zyprexa PS Eli Lilly And Co 20 MG.DAY 9 MON Dysphagia Professional Vomiting Company Representative Date:08/29/00ISR Number: 3561926-4Report Type:Expedited (15-DaCompany Report #US_000847537 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Disorder Health Zyprexa PS Eli Lilly And Co Professional Lithobid (Lithium Carbonate) C Date:08/29/00ISR Number: 3561979-3Report Type:Expedited (15-DaCompany Report #CA_000801817 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Gastrointestinal Ulcer Health Morphine C Professional Other Date:08/29/00ISR Number: 3561981-1Report Type:Expedited (15-DaCompany Report #DE_000802856 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Neutropenia Health Leponex (Clozapine) C Platelet Count Decreased Professional Splenomegaly Other Date:08/29/00ISR Number: 3561982-3Report Type:Expedited (15-DaCompany Report #DE_000802857 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Health Tavor (Lorazepam) C Professional Radedorm Other (Notrazepam) C 24-Jun-2005 12:19 PM Page: 1047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/00ISR Number: 3561983-5Report Type:Expedited (15-DaCompany Report #EWC000807596 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa PS Eli Lilly And Co TRANSPLACENTAL Initial or Prolonged Complications Of Maternal Health Exposure To Therapeutic Professional Drugs Other Foetal Disorder Foetal Distress Syndrome Date:08/29/00ISR Number: 3561986-0Report Type:Expedited (15-DaCompany Report #DE_000802894 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Condition Aggravated Health Eosinophilia Professional Hyperhidrosis Other Restlessness Date:08/29/00ISR Number: 3561989-6Report Type:Expedited (15-DaCompany Report #US_000541228 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Health Zyprexa PS Eli Lilly And Co 12.5 MG/1 AT Life-Threatening Cardiac Arrest Professional BEDTIME Coma Valproic Acid C Electrocardiogram Qt Acetaminophen Prolonged W/Hydrocodone Encephalopathy Bitartrate C Tachycardia Ventricular Fibrillation Date:08/29/00ISR Number: 3561992-6Report Type:Expedited (15-DaCompany Report #US_000847621 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co 2 YR Professional Haldol (Haloperidol) C Company Representative Date:08/29/00ISR Number: 3561993-8Report Type:Expedited (15-DaCompany Report #US_000847625 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional Company Representative 24-Jun-2005 12:19 PM Page: 1048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/00ISR Number: 3561439-XReport Type:Direct Company Report # Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Health Zyprexa 5mg (Lilly) PS Lilly ZYPREXA 5MG Intervention to Professional Prevent Permanent Impairment/Damage Date:09/01/00ISR Number: 3563854-7Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Olanzapine PS ORAL 20MG AT NIGHT Deep Vein Thrombosis PO 8 MON Obesity Hctz C Pulmonary Embolism Weight Increased Date:09/01/00ISR Number: 3563958-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Olanzapine - Lilly PS Lilly ORAL 30MG PO DAILY Hospitalization - Ketoacidosis Depakote - Abbott SS Abbott ORAL 1.250MG PO Initial or Prolonged DAILY Required Intervention to Prevent Permanent Impairment/Damage Date:09/01/00ISR Number: 3564128-0Report Type:Expedited (15-DaCompany Report #243169 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Foreign Valium PS Hoffmann La Roche Initial or Prolonged Hormone Decreased Other Inc ORAL 3 DOSE FORM Dehydration DAILY, ORAL Hypernatraemia Lithium Microsol Hyperthyroidism (Lithium Bromide) SS ORAL ORAL Hypotension Zyprexa (Olanzapine) SS ORAL 1 DOSE FORM Nephrogenic Diabetes DAILY, ORAL Insipidus Tercian Polydipsia (Cyamemazine) 40 Polyuria Mg/Ml SS ORAL 25 MG 3 PER DAY ORAL Date:09/06/00ISR Number: 3566321-XReport Type:Expedited (15-DaCompany Report #EWC000807683 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Libido Increased Study Temesta (Lorazepam) C Logorrhoea Health Akineton (Biperiden Professional Hydrochloride) C Other 24-Jun-2005 12:19 PM Page: 1049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/00ISR Number: 3566328-2Report Type:Expedited (15-DaCompany Report #DE_000802883 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Initial or Prolonged Haematoma Health Remergil Petechiae Professional (Mirtazapine) C Thrombocytopenia Other Sostril (Ranitidine Hydrochloride) C Date:09/06/00ISR Number: 3566350-6Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 7.5mg Non-Insulin-Dependent (Lilly) PS Lilly ORAL 15MG PO QHS Glycosuria Haldol C Glycosylated Haemoglobin Cogentin C Increased Prilosec C Hyperglycaemia Nivea C Colace C Chlorpheneramine C Cepacol C Keri Lotion C Robitussin C Nitrostat C Mom C Tylenol C Maalox C Chapstick C Date:09/06/00ISR Number: 3566353-1Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 10mg (Lilly) PS Lilly ORAL 20MG PO QHS Non-Insulin-Dependent Multivitamins C Glycosuria Thiamine C Hyperglycaemia Weight Increased Date:09/06/00ISR Number: 3566384-1Report Type:Expedited (15-DaCompany Report #EWC000306074 Age:38 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Ascites Aspartate Aminotransferase Increased Blood Bilirubin Increased C-Reactive Protein Increased Cardiomegaly Congestive Cardiomyopathy Cough Difficulty In Walking Dyspnoea 24-Jun-2005 12:19 PM Page: 1050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ejection Fraction Abnormal Face Oedema Report Source Product Role Manufacturer Route Dose Duration Fatigue Foreign Zyprexa PS Eli Lilly And Co 5MG/ 1 DAY Hypokinesia Health Haldol C Hypoproteinaemia Professional Laboratory Test Abnormal Other Left Ventricular Failure Mitral Valve Incompetence Myocardial Fibrosis Oedema Peripheral Viral Infection Weight Increased Date:09/06/00ISR Number: 3566386-5Report Type:Expedited (15-DaCompany Report #EWC000807656 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Hepatitis A Health Citalopram C Jaundice Professional Liver Function Test Other Abnormal Date:09/06/00ISR Number: 3566387-7Report Type:Expedited (15-DaCompany Report #DE_000802884 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 12.5 MG/DAY Initial or Prolonged Phosphokinase Increased Health Dipiperon Blood Creatine Professional (Pipamperone) C Phosphokinase Mb Other Haldol (Haloperidol) C Increased Akineton (Biperiden Blood Lactate Hydrochloride) C Dehydrogenase Increased Rhabdomyolysis Date:09/06/00ISR Number: 3566388-9Report Type:Expedited (15-DaCompany Report #EWC000807687 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Hormone Decreased Health Tercian Dehydration Professional (Cyamemazine) C Hypernatraemia Other Valium (Diazepam) C Hyperthyroidism Lithium Microsol Hypotension (Lithium Bromide) C Nephrogenic Diabetes Insipidus Polydipsia Polyuria 24-Jun-2005 12:19 PM Page: 1051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/00ISR Number: 3566389-0Report Type:Expedited (15-DaCompany Report #GBS000806444 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Syndrome Health Renal Failure Acute Professional Company Representative Other Date:09/06/00ISR Number: 3566413-5Report Type:Expedited (15-DaCompany Report #EWC990703815 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Neutropenia Health Leponex (Clozapine) C Professional Other Date:09/06/00ISR Number: 3566423-8Report Type:Expedited (15-DaCompany Report #EWC990603506 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Neutropenia Health Professional Other Date:09/06/00ISR Number: 3566431-7Report Type:Expedited (15-DaCompany Report #EWC000707418 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Other Status Epilepticus Health Tercian Professional (Cyamemazine) C Company Representative Other Date:09/06/00ISR Number: 3566432-9Report Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Zyprexa 5mg (Lilly) PS Lilly Dilantin C Klonopin C Cogentin C Tegretol C Mag Ox C Mvi C Diabeta C 24-Jun-2005 12:19 PM Page: 1052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/00ISR Number: 3566443-3Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 10mg & 7.5mg Tab(Lilly) PS Lilly ORAL 17.5MG PO Q AM Lactulose C Vasotec C Glucophage C Glyburide C Multivitamins C Date:09/06/00ISR Number: 3566568-2Report Type:Expedited (15-DaCompany Report #EWC000807668 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Neutropenia Health Risperidal Professional (Risperidone) C Other Leponex (Clozapine) C Disipal (Orphenadrine Hydrochloride) C Propavan (Propiomazine Maleate) C Zoloft (Sertraline Hydrochloride) C Date:09/06/00ISR Number: 3566641-9Report Type:Expedited (15-DaCompany Report #EWC000506821 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co Status Epilepticus Health Professional Company Representative Other Date:09/06/00ISR Number: 3566643-2Report Type:Expedited (15-DaCompany Report #EWC000606949 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Echocardiogram Abnormal Health Efexor (Venlafaxine Electrocardiogram Change Professional Hydrochloride) C Lung Disorder Other Rivotril (Clonazepam) C Date:09/06/00ISR Number: 3566645-6Report Type:Expedited (15-DaCompany Report #EWC000707389 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Other Paralysis Foreign Health Professional 24-Jun-2005 12:19 PM Page: 1053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 30 MG DAY Lepticur (Tropatepine Hydrochloride) C Rivotril (Clonazepam) C Depamide (Valpromide) C Imovane (Zopiclone) C Noctamide (Lormetazepam) C Date:09/06/00ISR Number: 3566939-4Report Type:Expedited (15-DaCompany Report #US_000643547 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Hospitalization - Diverticulitis Health Sertraline C Initial or Prolonged Erythropenia Professional Donepezil C Gastrointestinal Disorder Vitamin E C Haematochezia Aspirin C Haematocrit Decreased Iron C Haemoglobin Decreased Dulcolax C Hypotension Bisacodyl C Rectal Haemorrhage Date:09/06/00ISR Number: 3566947-3Report Type:Expedited (15-DaCompany Report #US_000847947 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Health Zyprexa PS Eli Lilly And Co 25 MG/DAY 4 MON Overdose Professional Weight Increased Date:09/06/00ISR Number: 3566963-1Report Type:Expedited (15-DaCompany Report #US_000847866 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Thyroid Stimulating Consumer Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY 7 MON Hormone Decreased Celexa (Citalopram Leukopenia Hydrobromide) C Sleep Disorder Depakote (Valproate Thyroid Function Test Semisodium) C Abnormal Tri-Iodothyronine Increased Tri-Iodothyronine Uptake Increased Weight Decreased Weight Increased 24-Jun-2005 12:19 PM Page: 1054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/00ISR Number: 3566964-3Report Type:Expedited (15-DaCompany Report #US_000848300 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Professional Paxil (Paroxetine Company Hydrochloride) C Representative Date:09/07/00ISR Number: 3566480-9Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 5mg (Lilly) PS Lilly ORAL 5MG PO Q HS Inadequate Control Zocor C Vasotec C Glucophage C Diabeta C Sliding Scale Humulin R C Thiamine C Asa C Date:09/07/00ISR Number: 3566484-6Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Zyprexa 10mg (Lilly) PS Lilly ORAL 20MG PO Q HS Humulin R Sliding Scale C Proventil C Effexor Xr C Diflucan C Glucophage C Azmaront C Tegretol C Celexa C Tylenol C Metamucil C Date:09/07/00ISR Number: 3566492-5Report Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Zyprexa 7.5 Mg Tabs Diabetes Mellitus (Lilly) PS Lilly Inadequate Control Colace C Prolixin-D C Cogentin C Lithium C Diabeta C Glucophage C Prilosec C Ativan C Synthroid C 24-Jun-2005 12:19 PM Page: 1055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/00ISR Number: 3567441-6Report Type:Expedited (15-DaCompany Report #A030086 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Disorder Health Norvasc PS Pfizer Agricultural Renal Vessel Disorder Professional Div Zyprexa SS Paxil SS Date:09/08/00ISR Number: 3568244-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Zyprexa 5 Mg Po PS ORAL 5MG HS PO Convulsion Professional Norvasc C Hyperhidrosis Pupil Fixed Date:09/08/00ISR Number: 3568248-6Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis Health Olanzapine 10mg Hospitalization - Professional Tablet Lilly PS Lilly ORAL 10MG HS ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:09/08/00ISR Number: 3568253-XReport Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Health Olanzapine 10mg Initial or Prolonged Professional Tablet Lilly PS Lilly ORAL 10MG HS ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:09/08/00ISR Number: 3568296-6Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa 10mg PS ORAL QHS PO Initial or Prolonged Professional Date:09/08/00ISR Number: 3568402-3Report Type:Expedited (15-DaCompany Report #A014542 Age:65 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 1056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Foreign Zoloft PS Pfizer Health Pharmaceuticals Inc ORAL 50.00 MG Professional TOTAL:DAILY:O RAL Zyprexa SS Rivotril C Nolvadex C Depakine Chrono C Levothyrox C Date:09/12/00ISR Number: 3570273-6Report Type:Expedited (15-DaCompany Report #US_000643180 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Prerenal Failure Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Anorexia Professional Carbamazepine C Dehydration Gemfibrozil C Diarrhoea Nicotine Dermal Nausea Patch (Nicotine Sedation Resin) C Vomiting Lomotil C Lorazepam C Cortisporin Opthalmic Suspension C Estradiol C Date:09/12/00ISR Number: 3570293-1Report Type:Expedited (15-DaCompany Report #US_000643175 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Life-Threatening Blood Creatine Increased Professional Doxepin C Hospitalization - Coma Metoprolol C Initial or Prolonged Convulsion Lasix (Furosemide) C Disability Encephalopathy Kcl-Retard Glomerulonephritis (Potassium Sodium) C Haemodialysis Tylenol Hypertrophic Obstructive (Paracetamol) C Cardiomyopathy Albuterol C Mental Impairment Kefzol (Cefazolin Nausea Sodium) C Oedema Depakote (Valproate Renal Failure Acute Semisodium) C Renal Impairment Ibuprofen C Respiratory Failure Loxitane (Loxapine Sedation Succinate) C Sepsis Risperdal Staphylococcal Infection (Risperidone) C Vomiting 24-Jun-2005 12:19 PM Page: 1057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/00ISR Number: 3570295-5Report Type:Expedited (15-DaCompany Report #US_000847866 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Thyroid Stimulating Consumer Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY 7 MON Hormone Decreased Health Celexa (Citalopram Insomnia Professional Hydrochloride) C Leukopenia Depakote (Valproate Neutropenia Semisodium) C Tri-Iodothyronine Increased Tri-Iodothyronine Uptake Increased Weight Decreased Weight Increased Date:09/12/00ISR Number: 3570325-0Report Type:Expedited (15-DaCompany Report #US_000846410 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Health Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY Hospitalization - Blood Follicle Professional Prozac (Fluoxetine Initial or Prolonged Stimulating Hormone Company Hydrochloride) SS 50 MG/1 DAY 8 YR Other Increased Representative Estradiol C Blood Luteinising Hormone Xanax (Alprazolam) C Increased Reglan Cardiac Arrest (Metoclopramide) C Condition Aggravated Potassium C Delusion Galactorrhoea Hypokalaemia Syncope Ventricular Tachycardia Vomiting Date:09/12/00ISR Number: 3570327-4Report Type:Expedited (15-DaCompany Report #US_990521974 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY 2 YR Initial or Prolonged Phosphokinase Increased Professional Prozac (Fluoxetine Blood Thyroid Stimulating Hydrochloride) SS 20 MG/DAY Hormone Increased Lovastatin C Hypothyroidism Diazepam C Myalgia Terazosin C Neuroleptic Malignant Risperidone C Syndrome Diphenhydramine C Pain Ranitidine C Peripheral Coldness Simvastatin C Date:09/12/00ISR Number: 3570328-6Report Type:Expedited (15-DaCompany Report #US_000848627 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Company Zyprexa PS Eli Lilly And Co 5 MG/1 DAY 10 DAY Haemorrhage Representative Adderall C Joint Swelling 24-Jun-2005 12:19 PM Page: 1058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/00ISR Number: 3570330-4Report Type:Expedited (15-DaCompany Report #US_000848424 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysuria Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY 3 MON Haematuria Professional Prozac (Fluoxetine Micturition Urgency Hydrochloride) SS 20 MG/1 DAY 6 MON Date:09/12/00ISR Number: 3570332-8Report Type:Expedited (15-DaCompany Report #US_000848436 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Petechiae Health Zyprexa PS Eli Lilly And Co 5 MG/1 AT Pyrexia Professional BEDTIME Rash Pruritic Lovenox (Heparin-Fraction, Sodium Salt) C Dilantin (Phenytoin Sodium) C Date:09/12/00ISR Number: 3570436-XReport Type:Expedited (15-DaCompany Report #GBS000906509 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Rhabdomyolysis Health Professional Other Date:09/12/00ISR Number: 3570437-1Report Type:Expedited (15-DaCompany Report #AU_991200960 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Liver Function Test Health Abnormal Professional Other Date:09/12/00ISR Number: 3570439-5Report Type:Expedited (15-DaCompany Report #EWC000907791 Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Back Pain Blood Creatinine Increased Blood Lactate Dehydrogenase Increased Blood Pressure Diastolic Decreased Blood Pressure Diastolic Increased Bradycardia Cardiac Disorder Cardiac Valve Disease Cardiomegaly Congestive Cardiomyopathy Decreased Appetite 24-Jun-2005 12:19 PM Page: 1059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Exertional Echocardiogram Abnormal Ejection Fraction Report Source Product Role Manufacturer Route Dose Duration Abnormal Foreign Zyprexa PS Eli Lilly And Co 40 MG/DAY Flatulence Health Newace (Fosinopril Hyponatraemia Professional Sodium) C Insomnia Other Bumetanide C Mitral Valve Disease Nausea Nocturia Oedema Peripheral Pleural Effusion Pulmonary Oedema Tachycardia Throat Irritation Ventricular Hypertrophy Weight Decreased Date:09/12/00ISR Number: 3570440-1Report Type:Expedited (15-DaCompany Report #EWC000807762 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Zyprexa PS Eli Lilly And Co Leukopenia Seroxat C Lymphopenia Lorazepam C PO Neutropenia Date:09/12/00ISR Number: 3570441-3Report Type:Expedited (15-DaCompany Report #DE_000802956 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 IN Initial or Prolonged Dyspnoea Health THE MORNING Loss Of Consciousness Professional Haldol Depot Movement Disorder Other (Haloperidol Pneumonia Decanoate) C Respiratory Failure Respiratory Gas Exchange Disorder Date:09/12/00ISR Number: 3570442-5Report Type:Expedited (15-DaCompany Report #EWC000807737 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 0.5 MG/DAY Leukopenia Health Semap (Penfluridol) C Neutropenia Professional Leponex (Clozapine) C Other Orap (Pimozide) C Lithium Carbonate C Date:09/12/00ISR Number: 3570443-7Report Type:Expedited (15-DaCompany Report #EWC000807720 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Neutropenia Foreign Neutrophilia Health Professional 24-Jun-2005 12:19 PM Page: 1060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 20 MG/DAY Oxazepam C Date:09/12/00ISR Number: 3570444-9Report Type:Expedited (15-DaCompany Report #EWC000807729 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 1 DSG Neutropenia Health FORM/DAY Professional Seroxat (Paroxetine Other Hydrochloride) C Stilnoct (Zolpidem Tartrate0 C Date:09/12/00ISR Number: 3570450-4Report Type:Expedited (15-DaCompany Report #EWC000105538 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Mania Health Tercian Professional (Cyamemazine) C Other Date:09/12/00ISR Number: 3570451-6Report Type:Expedited (15-DaCompany Report #DE_000602576 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Menstrual Disorder Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Ovarian Cancer Health Contraceptivum E C Ovarian Cyst Professional Other Date:09/12/00ISR Number: 3570452-8Report Type:Expedited (15-DaCompany Report #CA_000401405 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Confusional State Health Topamax (Topiramate) C Convulsion Professional Clonazepam C Diabetic Coma Company Cipro (Ciprofloxacin Dialysis Representative Hydrochloride) C Disorientation Other Paxil (Paroxetine Gastritis Erosive Hydrochloride) C Hyperglycaemia Hypervigilance Nausea Neuropathy Peripheral Polydipsia Polyuria Pyrexia Renal Failure Acute Upper Gastrointestinal Haemorrhage Vomiting 24-Jun-2005 12:19 PM Page: 1061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/00ISR Number: 3570511-XReport Type:Expedited (15-DaCompany Report #DE_000802946 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Required Condition Aggravated Literature Intervention to Neutropenia Health Prevent Permanent Professional Impairment/Damage Other Date:09/12/00ISR Number: 3571046-0Report Type:Expedited (15-DaCompany Report #EWC000707451 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS Eli Lilly And Co 700 MG/DAY Initial or Prolonged Loss Of Consciousness Health Lorazepam C Respiratory Disorder Professional Suicide Attempt Company Representative Other Date:09/12/00ISR Number: 3571052-6Report Type:Expedited (15-DaCompany Report #EWC000105540 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Other Date:09/13/00ISR Number: 3571419-6Report Type:Expedited (15-DaCompany Report #A030086 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Norvasc PS Pfizer Agricultural Arrhythmia Professional Div Blood Creatinine Zyprexa SS Increased Paxil SS Blood Urea Increased Fall Renal Disorder Renal Impairment Ventricular Hypertrophy Date:09/14/00ISR Number: 3570945-3Report Type:Direct Company Report # Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Olanzapine (Zyprexa, Initial or Prolonged Insulin-Dependent Eli Lilly) PS Eli Lilly ORAL 20MG PO Required QHS;30MG PO Intervention to QHS Prevent Permanent Clonazepam C Impairment/Damage Quetiapine C Haloperidol C 24-Jun-2005 12:19 PM Page: 1062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/00ISR Number: 3571645-6Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Zyprexa 5 Mg; (Eli Syncope Professional Lilly) PS Eli Lilly ORAL 5MG PO Q HS 1 DOSE Prozac C Date:09/15/00ISR Number: 3572025-XReport Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Chlorpromazine 50mg PS ORAL 50MG TID ORAL Initial or Prolonged Drooling YEARS Mental Impairment Olanzapine 5mg SS ORAL 5MG TID ORAL Tardive Dyskinesia Albuterol C Baclofen C Divalproex C Folic Acid C Gabapentin C Nimodipine C Ranitidine C Thiamine C Trazodone C Vit E C Date:09/18/00ISR Number: 3573124-9Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sedation Olanzapine PS Intervention to Prevent Permanent Impairment/Damage Date:09/18/00ISR Number: 3573429-1Report Type:Periodic Company Report #9940689 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Navane PS Roerig Div Pfizer Amenorrhoea Professional Inc 40MG Anxiety TOTAL/DAILY/ Asthenia Norplant SS SUBCUTANEOUS SUBCUTANEOUS Depression Zyprexa SS 20MG TOTAL; Hypertonia DAILY Muscle Twitching Photosensitivity Reaction Weight Increased Date:09/18/00ISR Number: 3573437-0Report Type:Periodic Company Report #A010999 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Navane PS Roerig Div Pfizer Pain Inc ORAL 10MG Rhinitis TOTAL/DAILY/O Sedation RAL 24-Jun-2005 12:19 PM Page: 1063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal SS ORAL ORAL Zyprexa SS ORAL 20MG TOTAL/DAILY/O RAL Date:09/18/00ISR Number: 3574579-6Report Type:Expedited (15-DaCompany Report #EWC000907797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Zyprexa PS Eli Lilly And Co Hospitalization - Exposure To Therapeutic Health Initial or Prolonged Drugs Professional Congenital Anomaly Heart Disease Congenital Company Representative Other Date:09/18/00ISR Number: 3574597-8Report Type:Expedited (15-DaCompany Report #AU_000601468 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS Eli Lilly And Co Suicide Attempt Health Valproate Sodium C Professional Fluvoxamine C Date:09/18/00ISR Number: 3574603-0Report Type:Expedited (15-DaCompany Report #EWC000707335 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Health Sinemet C Professional Tanakan (Ginkgo Tree Company Leaves Extract) C Representative Lipanthyl Other (Fenofibrate) C Kardegic (Acetylsalicylate Lysine) C Date:09/18/00ISR Number: 3574604-2Report Type:Expedited (15-DaCompany Report #EWC000907815 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Norset (Mirtazapine) C Professional Other Date:09/18/00ISR Number: 3574605-4Report Type:Expedited (15-DaCompany Report #EWC000907858 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Foreign Zyprexa PS Eli Lilly And Co 15MG/DAY Initial or Prolonged Health Chlorpropamide C Professional Carbolithium Other (Lithium Carbonate) C 24-Jun-2005 12:19 PM Page: 1064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/00ISR Number: 3574824-7Report Type:Expedited (15-DaCompany Report #US_000746153 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Arteriosclerosis Lansoprazole C Cardiomegaly Vitamin B12 With Coma Zinc C Dyspnoea Vitamin E C Hepatic Steatosis Pulmonary Oedema Date:09/18/00ISR Number: 3574830-2Report Type:Expedited (15-DaCompany Report #US_980401339 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Study Zyprexa PS Eli Lilly And Co 30 WK Initial or Prolonged Exposure To Therapeutic Literature Drugs Health Hypoglycaemia Neonatal Professional Neonatal Respiratory Distress Syndrome Premature Baby Date:09/18/00ISR Number: 3574840-5Report Type:Expedited (15-DaCompany Report #US97083184A Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eclampsia Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY 261 DAY Initial or Prolonged Gestational Diabetes Literature Folic Acid C Hypothyroidism Health Pepcid (Famotidine) C Liver Function Test Professional Insulin C Abnormal Multivitamins Nos Pre-Eclampsia (Multivitamins Nos) C Pregnancy Synthroid Pregnancy Induced (Levothyroxine Hypertension Sodium) C Proteinuria Sedation Weight Increased Date:09/18/00ISR Number: 3574847-8Report Type:Expedited (15-DaCompany Report #US_000948744 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS Eli Lilly And Co 2.5 MG /1 DAY 2 DAY Professional Depakote (Valproate Company Semisodium) C Representative Date:09/18/00ISR Number: 3575007-7Report Type:Expedited (15-DaCompany Report #US_000948909 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Fibrillation Health Zyprexa PS Eli Lilly And Co UNKNOWN UNKNOWN Professional Thioridazine C Diphenhydramine C Benzatropine C 24-Jun-2005 12:19 PM Page: 1065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/00ISR Number: 3575008-9Report Type:Expedited (15-DaCompany Report #US_000948999 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Study Zyprexa PS Eli Lilly And Co UNKNOWN 2 DSG FORM Insomnia Other DAY UNKNOWN Sedation Date:09/18/00ISR Number: 3575053-3Report Type:Expedited (15-DaCompany Report #US_000949014 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Crying Ritalin Epistaxis (Methylphenidate Hyperhidrosis Hydrochloride) C Thirst Depakote (Valproate Semisodium) C Clonidine C Date:09/19/00ISR Number: 3574727-8Report Type:Direct Company Report # Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Olanzapine Initial or Prolonged Glycosylated Haemoglobin (Zyprexa, Eli Lilly) PS Eli Lilly ORAL SEE IMAGE Required Increased Clonazepam C Intervention to Hyperglycaemia Quetiapine C Prevent Permanent Haloperidol C Impairment/Damage Date:09/20/00ISR Number: 3576713-0Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sedation Olanzapine PS ORAL 10 MG PO HS Intervention to Prevent Permanent Impairment/Damage Date:09/20/00ISR Number: 3576714-2Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sedation Olanzapine PS ORAL 5MG PO HS Intervention to Prevent Permanent Impairment/Damage Date:09/25/00ISR Number: 3579289-7Report Type:Expedited (15-DaCompany Report #US_990319390 Age:24 YR Gender:Male I/FU:I Outcome PT Alopecia Diabetes Mellitus Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 1066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphadenopathy Monocyte Count Increased Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS Eli Lilly And Co 15 MG/1 DAY 3 YR Health Lithobid C Professional Date:09/25/00ISR Number: 3579290-3Report Type:Expedited (15-DaCompany Report #US_000949655 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Red Blood Cell Count Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Decreased Professional Artane C White Blood Cell Count Visken C Decreased Haldol C Vistaril C Date:09/25/00ISR Number: 3579307-6Report Type:Expedited (15-DaCompany Report #US_000846653 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Study Zyprexa PS Eli Lilly And Co 6 MG Hospitalization - Abscess Health Fluoxetine Initial or Prolonged Atrial Fibrillation Professional (Fluoxetine Blood Albumin Decreased Hydrochloride) SS 75 MG Blood Creatine Humalog (Insulin Phosphokinase Increased Lispro) C Blood Creatinine Ultralente Insulin Increased (Insulin Zinc Blood Lactic Acid Suspension) C Increased Asa (Acetylsalicylic Blood Urea Increased Acid) C Calculus Ureteric Multivitamin C Cholelithiasis Ferrous Sulfate C Condition Aggravated Dermatitis Disseminated Intravascular Coagulation Dysarthria Fatigue Fibrin D Dimer Increased Haematocrit Decreased Liver Function Test Abnormal Nephrolithiasis Neutropenia Osteomyelitis Pulmonary Oedema Renal Impairment Respiratory Failure Rhabdomyolysis Staphylococcal Sepsis Thrombocytopenia Toxic Epidermal Necrolysis 24-Jun-2005 12:19 PM Page: 1067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579310-6Report Type:Expedited (15-DaCompany Report #US_000949299 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Zyprexa PS Eli Lilly And Co 20 MG/1 IN Initial or Prolonged Depression Health THE EVENING Emotional Distress Professional Hallucination, Auditory Hallucination, Olfactory Hallucination, Tactile Oral Intake Reduced Psychotic Disorder Suicidal Ideation Date:09/25/00ISR Number: 3579369-6Report Type:Expedited (15-DaCompany Report #GBS000906569 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Dianette C Professional Other Date:09/25/00ISR Number: 3579370-2Report Type:Expedited (15-DaCompany Report #GBS000906568 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Jaundice Health Nefazodone C Liver Function Test Professional Ranitidine C Abnormal Other Alkaline Phosphatase C Date:09/25/00ISR Number: 3579371-4Report Type:Expedited (15-DaCompany Report #EWC000907941 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Increased Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Haemoglobin Increased Health Anafranil Red Blood Cell Count Professional (Clomipramine Increased Other Hydrochloride) C Date:09/25/00ISR Number: 3579373-8Report Type:Expedited (15-DaCompany Report #EWC000907928 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Haematocrit Increased Health Lorazepam C Haemoglobin Increased Professional Psychotic Disorder Other Red Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 1068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579374-XReport Type:Expedited (15-DaCompany Report #EWC000907923 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Foreign Zyprexa PS Eli Lilly And Co Hospitalization - Loss Of Consciousness Health Citalopram C Initial or Prolonged Precerebral Artery Professional Temazepam C Occlusion Other Date:09/25/00ISR Number: 3579416-1Report Type:Expedited (15-DaCompany Report #US_000949371 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional Celexa (Citalopram Hydrobromide) C Date:09/25/00ISR Number: 3579423-9Report Type:Expedited (15-DaCompany Report #CA_000901926 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Phosphokinase Increased Health Blood Creatine Professional Phosphokinase Mb Company Increased Representative Cardiac Failure Other Congestive Coma Confusional State Differential White Blood Cell Count Abnormal Electrocardiogram Abnormal Electrocardiogram T Wave Inversion Hypotension Leukocytosis Lower Respiratory Tract Infection Mental Impairment Oliguria Pleural Effusion Pulmonary Oedema Rhonchi Date:09/25/00ISR Number: 3579425-2Report Type:Expedited (15-DaCompany Report #GBS000906548 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Foreign Zyprexa PS Eli Lilly And Co 10 MG Health Professional Other 24-Jun-2005 12:19 PM Page: 1069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579428-8Report Type:Expedited (15-DaCompany Report #DE_000903083 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Thrombocytopenia Health Convallocor Sl C Professional Hepatofalk C Other Mutaflor C Gallemolan C Date:09/25/00ISR Number: 3579452-5Report Type:Expedited (15-DaCompany Report #DE_000903072 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Health Professional Other Date:09/25/00ISR Number: 3579457-4Report Type:Expedited (15-DaCompany Report #EWC000907909 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Foreign Zyprexa PS Eli Lilly And Co Health Nortriptyline C Professional Other Date:09/25/00ISR Number: 3579458-6Report Type:Expedited (15-DaCompany Report #EWC000907844 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemodialysis Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Renal Failure Acute Health Beta-Blockers C Rhabdomyolysis Professional Aspirin Cardio Other (Acetylsalicylic Acid) C Limpidex (Lansoprazole) C Date:09/25/00ISR Number: 3579460-4Report Type:Expedited (15-DaCompany Report #CA_000901937 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Drug Toxicity Health Fluoxetine Intentional Misuse Professional (Fluoxetine Other Hydrochloride) SS Bupropion Hydrochloride C Lorazepam C Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 1070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579463-XReport Type:Expedited (15-DaCompany Report #EWC000506839 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Lithium PS 3600 MG/DAY Initial or Prolonged Mania Study Olanzapine SS 7.5 MG/DAY Mood Altered Health Lorazepam C Psychomotor Hyperactivity Professional Suicide Attempt Other Date:09/25/00ISR Number: 3579487-2Report Type:Expedited (15-DaCompany Report #EWC000506819 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY Aspiration Health Nozinan Haematemesis Professional (Levomepromazine) C Medication Error Other Aspirine Overdose (Acetylsalicylic Sedation Acid) C Tercian (Cymemazine) C Kardegic (Acetylsalilcylate Lysine) C Ditropan (Oxybutynin) C Rivotril (Clonazepam) C Staltor (Cerivastatin) C Date:09/25/00ISR Number: 3579488-4Report Type:Expedited (15-DaCompany Report #DE_000802956 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 IN Hospitalization - Dehydration Health THE MORNING 1 DAY Initial or Prolonged Dyspnoea Professional Haldol Depot Hypokinesia Other (Haloperidol Loss Of Consciousness Decanoate) C Pulmonary Embolism Respiratory Failure Date:09/25/00ISR Number: 3579490-2Report Type:Expedited (15-DaCompany Report #DE_000802884 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 12.5 MG/DAY Initial or Prolonged Phosphokinase Increased Health Dipiperon Blood Lactate Professional (Pipamperone) C Dehydrogenase Increased Other Haldol (Haloperidol) C Condition Aggravated Akineton (Biperiden Rhabdomyolysis Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579491-4Report Type:Expedited (15-DaCompany Report #DE_000802809 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 3 MON Health Professional Other Date:09/25/00ISR Number: 3579576-2Report Type:Expedited (15-DaCompany Report #US_000949245 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pain Health Fluoxetine Hcl PS Lilly Research Professional Laboratories Div Eli Company Lilly And Co 40 MG/1DAY Representative Zyprexa (Olanzapine) SS 10 MG/1 DAY Xanax (Alprazolam) C Luvox (Fluvoxamine Maleate) C Date:09/25/00ISR Number: 3579614-7Report Type:Expedited (15-DaCompany Report #US_000846410 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Health Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY Hospitalization - Blood Follicle Professional Prozac (Fluoxetine Initial or Prolonged Stimulating Hormone Company Hydrochloride) SS 50 MG/1 DAY 8 YR Other Increased Representative Estradiol C Blood Luteinising Hormone Xanax (Alprazolam) C Increased Potassium C Cardiac Arrest Reglan Condition Aggravated (Metoclopramide) C Delusion Electrocardiogram Qt Prolonged Galactorrhoea Hypokalaemia Syncope Ventricular Tachycardia Vomiting Date:09/25/00ISR Number: 3579619-6Report Type:Expedited (15-DaCompany Report #US_000847251 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autoimmune Hepatitis Health Fluoxetine Hcl PS Lilly Research Blood Bilirubin Increased Professional Laboratories Div Eli Hallucination Company Lilly And Co 20 MG/1 DAY Hepatitis Chronic Active Representative Zyprexa (Olanzapine) SS 2.5 MG/1 DAY Jaundice Paxil (Paroxetine Liver Function Test Hydrochloride) C Abnormal Psychotic Disorder 24-Jun-2005 12:19 PM Page: 1072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579706-2Report Type:Expedited (15-DaCompany Report #US_000949207 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Axid PS Eli Lilly And Co Initial or Prolonged Delusion Health Olanzapine SS 15 MG/1 DAY Psychotic Disorder Professional Ativan (Lorazepam) C Date:09/25/00ISR Number: 3579749-9Report Type:Expedited (15-DaCompany Report #US_000948999 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Study Zyprexa PS Eli Lilly And Co 2 DSG Insomnia Other FORM/DAY Sedation Date:09/26/00ISR Number: 3580410-5Report Type:Direct Company Report # Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Zyprexa 15 Mg PS ORAL 15 MG P.O. Q DAY Zoloft 200 Mg Qhs SS 200 MG QHS Date:09/26/00ISR Number: 3580490-7Report Type:Expedited (15-DaCompany Report #A0127997A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Wellbutrin PS Glaxo Wellcome Inc ORAL 150 MG/ TWICE Drug Level Above Health PER DAY/ORAL Therapeutic Professional Olanzapine SS Intentional Misuse Other Fluoxetine SS Toxicologic Test Abnormal Lorazepam C Haloperidol C Date:09/27/00ISR Number: 3581422-8Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Olanzapine PS ORAL 20MG PO Q HS Intervention to Weight Increased Depakote C Prevent Permanent Cogentin C Impairment/Damage Date:09/27/00ISR Number: 3581712-9Report Type:Expedited (15-DaCompany Report #2000UW03450 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Dystonia Professional Zyprexa SS Effexor SS 24-Jun-2005 12:19 PM Page: 1073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/00ISR Number: 3584462-8Report Type:Expedited (15-DaCompany Report #A0128346A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Wellbutrin PS Glaxo Wellcome Inc ORAL ORAL 2 MON Semen Abnormal Olanzapine Spermatozoa Abnormal (Formulation Unknown) (Olanzapine) SS Date:10/02/00ISR Number: 3585504-6Report Type:Expedited (15-DaCompany Report #ENT00180 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Attention Other Comtan PS Orion Corp ORAL 1000 MG 26 DAY Hospitalization - Deficit/Hyperactivity Zyprexa Olanzapine SS ORAL 5 MG 23 DAY Initial or Prolonged Disorder Sifrol Pramipexole SS ORAL 2.1 MG 9 DAY Blood Creatine Levodopa-Carbidopa C Phosphokinase Increased Parkotil Pergolide C Blood Creatinine Increased Chills Chromaturia Drug Interaction Gait Disturbance Haematuria Hallucination, Visual Hepatic Function Abnormal Hypercholesterolaemia Liver Function Test Abnormal Motor Dysfunction Muscular Weakness Musculoskeletal Stiffness Myalgia Myoglobinuria Pollakiuria Rhabdomyolysis Salivary Hypersecretion Scoliosis Speech Disorder Urinary Incontinence Date:10/02/00ISR Number: 3586168-8Report Type:Periodic Company Report #2000031 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Keppra PS Ucb Pharma Inc ORAL 500 MG 2/D PO Initial or Prolonged Sedation Professional Olanzapine SS ORAL 10 MG 1/D PO Suicide Attempt Ativan C Date:10/03/00ISR Number: 3586506-6Report Type:Expedited (15-DaCompany Report #US_000948909 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Zyprexa PS Eli Lilly And Co 20MG/1 DAY Drug Level Above Professional Thioridazine C Therapeutic Diphenhydramine C Benzatropine C 24-Jun-2005 12:19 PM Page: 1074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft(Sertraline Hydrochloride) C Date:10/03/00ISR Number: 3586601-1Report Type:Expedited (15-DaCompany Report #EWC000907912 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Biopsy Bone Marrow Health Abnormal Professional Erysipelas Other Pyrexia Date:10/03/00ISR Number: 3586602-3Report Type:Expedited (15-DaCompany Report #AU_000902003 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa PS Eli Lilly And Co 10 MG/IN THE Initial or Prolonged Lower Respiratory Tract Study EVENING Infection Health Frusemide C Professional Slow-K (Potassium Other Chloride) C Captopril C Losec (Omeprazole) C Digoxin C Warfarin C Date:10/03/00ISR Number: 3586604-7Report Type:Expedited (15-DaCompany Report #EWC000907976 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Cardiomyopathy Health Largactil Initial or Prolonged Inflammation Professional (Chlorpromazine Pericarditis Other Hydrochloride) C Pulmonary Oedema Lepticur Pyrexia (Tropatepine Respiratory Disorder Hydrochloride) C Thrombosis Date:10/03/00ISR Number: 3586621-7Report Type:Expedited (15-DaCompany Report #EWC000807762 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 10MG/DAY Leukopenia Health Seroxat (Paroxetine Lymphopenia Professional Hydrochloride) C Neutropenia Other Lorazepam C Date:10/03/00ISR Number: 3586642-4Report Type:Expedited (15-DaCompany Report #CA_000901943 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Other Aneurysm Foreign Health Professional 24-Jun-2005 12:19 PM Page: 1075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Date:10/03/00ISR Number: 3586725-9Report Type:Expedited (15-DaCompany Report #US_000949769 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa PS Eli Lilly And Co Renal Colic Aspirin C Sedation Weight Increased Date:10/03/00ISR Number: 3586726-0Report Type:Expedited (15-DaCompany Report #US_000949876 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Haemorrhage Health Zyprexa PS Eli Lilly And Co 12.5 MG/DAY 15 MON Professional Mellaril Company (Thioridazine Representative Hydrochloride) C Phenytoin C Date:10/03/00ISR Number: 3586807-1Report Type:Expedited (15-DaCompany Report #GBS000706264 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Health Thyroxine C Professional Other Date:10/03/00ISR Number: 3586810-1Report Type:Expedited (15-DaCompany Report #EWC000406344 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Sedation Health Seroxat C Sinusitis Professional Lorazepam C Other Impromen C Haloperidol C Date:10/03/00ISR Number: 3586833-2Report Type:Expedited (15-DaCompany Report #CA_990800726 Age:58 YR Gender:Female I/FU:F Outcome PT Agitation Anger Ankle Fracture Condition Aggravated Cough Drooling Dysphonia Fall Influenza Like Illness 24-Jun-2005 12:19 PM Page: 1076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Irritability Leukopenia Report Source Product Role Manufacturer Route Dose Duration Lip Disorder Foreign Zyprexa PS Eli Lilly And Co 5 MG/AT Logorrhoea Health BEDTIME Mania Professional Loxapine C Mood Altered Company Clonazepam C Neutropenia Representative Lithium Citrate C Pyrexia Other Valproic Acid C Restlessness Zopiclone C Sedation Risperidone C Thrombocytopenia Benztropine C Tremor Date:10/03/00ISR Number: 3586847-2Report Type:Expedited (15-DaCompany Report #EWC000707451 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS Eli Lilly And Co 700 MG/DAY Initial or Prolonged Loss Of Consciousness Health Lorazepam C Respiratory Disorder Professional Suicide Attempt Company Representative Other Date:10/03/00ISR Number: 3586856-3Report Type:Expedited (15-DaCompany Report #CA_000801817 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Gastrointestinal Ulcer Health Morphine C Professional Other Date:10/03/00ISR Number: 3586859-9Report Type:Expedited (15-DaCompany Report #EWC000406390 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Consciousness Health Hyperpyrexia Professional Neuroleptic Malignant Other Syndrome Rhabdomyolysis Vomiting Date:10/03/00ISR Number: 3586879-4Report Type:Expedited (15-DaCompany Report #DE_000802838 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Phosphokinase Increased Health Lithium C Diabetes Mellitus Professional Diabetic Hyperosmolar Other Coma Renal Failure Acute Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 1077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/00ISR Number: 3586884-8Report Type:Expedited (15-DaCompany Report #US_000846653 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Study Fluoxetine Hcl PS Lilly Research Life-Threatening Abscess Health Laboratories Div Eli Hospitalization - Atrial Fibrillation Professional Lilly And Co 75 MG Initial or Prolonged Blood Creatine Olanzapine SS 6 MG Phosphokinase Increased Humalon (Insulin Blood Lactic Acid Lispro) C Increased Ultralente Insuli Blood Magnesium Decreased N(Insulin Zinc Calculus Ureteric Suspension) C Cholelithiasis Asa (Acetylsalicylic Dermatitis Acid) C Difficulty In Walking Mutlivitamin C Disseminated Ferrous Sulfate C Intravascular Coagulation Dysarthria Fatigue Fibrin D Dimer Increased Haematocrit Increased Hypokalaemia Hypoproteinaemia Hypotension Liver Function Test Abnormal Nephrolithiasis Neutropenia Oedema Osteomyelitis Pain In Extremity Pulmonary Oedema Renal Failure Acute Respiratory Failure Rhabdomyolysis Staphylococcal Sepsis Tachycardia Thrombocytopenia Toxic Epidermal Necrolysis Date:10/03/00ISR Number: 3587002-2Report Type:Expedited (15-DaCompany Report #US98010442A Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Dizziness Consumer Haloperidol C Drug Level Above Health Cogentin Therapeutic Professional (Benzathropine Drug Toxicity Other Mesilate) C Intentional Misuse Date:10/03/00ISR Number: 3587004-6Report Type:Expedited (15-DaCompany Report #US_980605558 Age:38 YR Gender:Male I/FU:F Outcome PT Death Accident Cardiac Disorder Coma 24-Jun-2005 12:19 PM Page: 1078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coronary Artery Disease Drug Toxicity Hepatic Congestion Report Source Product Role Manufacturer Route Dose Duration Hepatic Steatosis Literature Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Overdose Health Risperdal Pica Professional (Risperidone) C Renal Disorder Other Clonazepam C Scar Vomiting Date:10/03/00ISR Number: 3587006-XReport Type:Expedited (15-DaCompany Report #US_000745719 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa PS Eli Lilly And Co 5 MG/1 AT Initial or Prolonged Oedema Peripheral Professional BEDTIME 4 WK Psychotic Disorder Company Prozac (Fluoxetine Weight Increased Representative Hydrochloride) SS Tofranil (Imipramine Hydrochloride) C Date:10/03/00ISR Number: 3587069-1Report Type:Expedited (15-DaCompany Report #US_000949967 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Deep Vein Thrombosis Health Oxycodone C Insomnia Professional Allopurinol C Pain In Extremity Hydrochlorthiazide C Hydroxyzine C Indomethacin C Lansoprazole C Lisinopril C Propranolol C Trazodone C Diltiazem C Date:10/03/00ISR Number: 3587070-8Report Type:Expedited (15-DaCompany Report #US_000950175 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Zyprexa PS Eli Lilly And Co 7.5 MG/ 1 DAY 10 DAY Phosphatase Increased Professional Aspirin Enteric Blood Bilirubin Increased Coated C Blood Lactate Glyburide C Dehydrogenase Increased Benzylhydrochlorthia Haematocrit Decreased zide C Haemoglobin Decreased Metoprolol C Metformin C Quinapril C Date:10/03/00ISR Number: 3587071-XReport Type:Expedited (15-DaCompany Report #US_000950336 Age: Gender:Female I/FU:I Outcome PT Colitis Macrocytosis 24-Jun-2005 12:19 PM Page: 1079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin A Deficiency Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:10/04/00ISR Number: 3586155-XReport Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa 2.5mg(Olanzapine) PS Eli Lilly Zaroxolyn (Metolazone) SS Medeva Date:10/04/00ISR Number: 3587732-2Report Type:Expedited (15-DaCompany Report #HQ1598529SEP2000 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Artane PS Lederle Laboratories Initial or Prolonged Condition Aggravated Professional Div American Other Drug Interaction Other Cyanamid Co ORAL 2 MG DAILY Extrapyramidal Disorder ORAL 35 DAY Atarax (Hydroxyzine Hydrochloride) SS Zyprexa (Olanzapine) SS 18 DAY Imovane (Zopiclone) C Date:10/05/00ISR Number: 3588525-2Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Olanzapine PS ORAL QD ORAL Initial or Prolonged Cognitive Disorder Depakote SS ORAL ORAL Condition Aggravated Ativan SS ORAL ORAL Depression Drug Level Above Therapeutic Dysphoria Electrocardiogram Abnormal Elevated Mood Gastrointestinal Disorder Hypomania Lethargy Nervousness Overdose Suicidal Ideation Date:10/06/00ISR Number: 3589395-9Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 1080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Olanzapine PS ORAL 5 MG PO BID Syndrome AND 10 MG PO Oral Intake Reduced Q HS Pneumonia Maxide C Pyrexia Procardia-Xl C Serax C Zoloft C Tylenol C Date:10/06/00ISR Number: 3590726-4Report Type:Expedited (15-DaCompany Report #ENT00180 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Other Comtan PS Orion Corp ORAL 1000 MG 26 DAY Hospitalization - Increased Zyprexa (Olanzapine) SS ORAL 5 MG 23 DAY Initial or Prolonged Aspartate Nacom Other Aminotransferase (Levodopa-Carbidopa) C Increased Parkotil (Pergolide) C Blood Creatine Sifrol (Pramipexole) C Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Chromaturia Drug Interaction Haematuria Haemoglobinuria Hepatic Function Abnormal Rhabdomyolysis Date:10/10/00ISR Number: 3590751-3Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Olanzapine 2.5 Mg Hospitalization - Hyperglycaemia Lilly PS Lilly 2.5 MG QHS Initial or Prolonged Hypotension PER NG Dilantin C Heparin C Tylenol C Florinef C Iron Supplement C Zinc Sulfate C Prevacid C Prozac C Multivitamins C Date:10/10/00ISR Number: 3592482-2Report Type:Expedited (15-DaCompany Report #HQ1598529SEP2000 Age:54 YR Gender:Male I/FU:F Outcome PT Hospitalization - Akathisia Initial or Prolonged Attention Other Deficit/Hyperactivity Disorder 24-Jun-2005 12:19 PM Page: 1081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Drug Interaction Extrapyramidal Disorder Report Source Product Role Manufacturer Route Dose Duration Health Artane PS Lederle Laboratories Professional Div American Other Cyanamid Co ORAL INITIAL DOSE UNKNOWN; DOSE WAS INCREASED FROM 2 MG TO 10 MG/ 35 DAY Atarax (Hydroxyzine Hydrochloride) SS DOSE UNKNOWN Lexomil (Bromazepam) SS 17 DAY Tiapridal (Tiapride) SS Zyprexa SS Tranxene (Clorazepate, Dipotassium) SS Imovane (Zopiclone) C Stilnox (Zolpidem) C Date:10/11/00ISR Number: 3591939-8Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa Zydis Eli Lilly PS Eli Lilly ORAL ORAL Zydis (Apomorphine) Pentech /Scherer SS Pentech /Scherer Date:10/12/00ISR Number: 3594004-9Report Type:Expedited (15-DaCompany Report #US_000643152 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Consumer Humulin R Pen PS Eli Lilly And Co 110 U/DAY 11 YR Initial or Prolonged Cardiac Failure Prozac (Fluoxetine Other Congestive Hydrochloride) SS 20 MG/DAY Condition Aggravated Zyprexa (Olanzapine) SS 5 MG/1 IN THE Depression EVENING 11 YR Diabetic Ulcer Actos (Pioglitazone) C Endocarditis Lithium Carbonate C Fall Restoril (Temazepam) C Heart Rate Decreased Digoxin C Implant Site Infection Lasix C Infection Vitamin B Complex C Insomnia Zestril C Oedema Peripheral Weight Decreased Date:10/12/00ISR Number: 3594014-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Endocrine Disorder Zyprexa 7.5mg 10mg Disability Reproductive Tract 5mg PS VARIED ON Disorder WHAT THEY Sperm Count Decreased WANT TO SEE! 24-Jun-2005 12:19 PM Page: 1082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/00ISR Number: 3594566-1Report Type:Expedited (15-DaCompany Report #EWC000908077 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Zyprexa PS Eli Lilly And Co 10 MG /DAY Blood Creatine Health Phosphokinase Increased Professional Myalgia Company Neutropenia Representative Other Date:10/12/00ISR Number: 3594568-5Report Type:Expedited (15-DaCompany Report #EWC001008084 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Epistaxis Health Professional Other Date:10/12/00ISR Number: 3594569-7Report Type:Expedited (15-DaCompany Report #GBS000906620 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Foreign Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Health Professional Company Representative Other Date:10/12/00ISR Number: 3594570-3Report Type:Expedited (15-DaCompany Report #GBS000906633 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Other Date:10/12/00ISR Number: 3594571-5Report Type:Expedited (15-DaCompany Report #EWC000607013 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Decreased Appetite Health Fatigue Professional Gastrointestinal Other Haemorrhage Headache Hiv Infection Nausea Thrombocytopenia Vertigo 24-Jun-2005 12:19 PM Page: 1083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/00ISR Number: 3594576-4Report Type:Expedited (15-DaCompany Report #DE_000802856 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Neutropenia Health Leponex (Clozapine) C Splenomegaly Professional Risperdal Thrombocytopenia Other (Risperidone) C .... C ....... C ... C ... C ..... C .... C ... C ... C Date:10/12/00ISR Number: 3594743-XReport Type:Expedited (15-DaCompany Report #AU_000901972 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Balance Disorder Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Dystonia Health Serzone(Nefazodone Gait Disturbance Professional Hydrochloride) C Movement Disorder Company Kemadrin(Procyclidin Psychomotor Retardation Representative e Hydrochloride) C Other Amprace(Enalapril Maleate) C Diazepam C Panadeine C Deralin(Propranolol) C Date:10/12/00ISR Number: 3594744-1Report Type:Expedited (15-DaCompany Report #DE_000903176 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Differential White Blood Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Cell Count Abnormal Health Akineton Retard Leukopenia Professional (Biperiden Lymphocyte Count Abnormal Other Hydrochloride) C Neutropenia Euthyrox(Levothyroxi ne Sodium) C Tavor(Lorazepam) C Date:10/12/00ISR Number: 3594745-3Report Type:Expedited (15-DaCompany Report #EWC000908039 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Coma Health Gardenal(Phenobarbit Professional al) C Company Tercian(Cyamemazine) C Representative Other 24-Jun-2005 12:19 PM Page: 1084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/00ISR Number: 3594746-5Report Type:Expedited (15-DaCompany Report #EWC000908051 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Melaena Health Mizollen(Mizolastine Professional ) C Other Antagel C Date:10/12/00ISR Number: 3594781-7Report Type:Expedited (15-DaCompany Report #DE_000602577 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Phosphokinase Increased Health Levomepromazine C Delirium Professional Fluanxol Neuroleptic Malignant Other (Flupentixol Syndrome Dihydrochloride) C Pyrexia Date:10/12/00ISR Number: 3594782-9Report Type:Expedited (15-DaCompany Report #EWC980801293 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS Eli Lilly And Co 280 MG/DAY Initial or Prolonged Depressed Level Of Literature Consciousness Health Depression Professional Dysphagia Company Family Stress Representative Intentional Misuse Other Muscle Rigidity Psychomotor Hyperactivity Sedation Suicide Attempt Visual Acuity Reduced Date:10/12/00ISR Number: 3595229-9Report Type:Expedited (15-DaCompany Report #US_000950691 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Shock Hypoglycaemic Health Darvocet-N 100 PS Eli Lilly And Co Professional Humulin-Human Nph Insulin (Rdna) (Human Insulin (Rdna Origin) SS 12 U/1 IN THE MORNING Zyperxa (Olanzapine) SS 2.5 MG/1 IN THE MORNING Remeron (Mirtazapine) C Furosemide C Vasotec (Enalapril Maleate) C Depakoate (Valproate Semisodium) C Aricept(Donepezil Hydrochloride) C Cholestryramine 24-Jun-2005 12:19 PM Page: 1085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Resin C Date:10/12/00ISR Number: 3595280-9Report Type:Expedited (15-DaCompany Report #US_000439298 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Health Zyprexa PS Eli Lilly And Co 20 MG/ DAY Initial or Prolonged Increased Professional Celexa (Citalopram Full Blood Count Abnormal Hydrobromide) C Medication Error Tegretol Rash Maculo-Papular (Carbamazepine) C Schizophrenia Date:10/12/00ISR Number: 3595281-0Report Type:Expedited (15-DaCompany Report #US_000949014 Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Consumer Zyprexa PS Eli Lilly And Co 5 MG/1DAY Epistaxis Health Ritalin Hyperhidrosis Professional (Methylphenidate Thirst Hydrochloride) C Depakote (Valproate Semisodium) C Clonidine C Date:10/12/00ISR Number: 3595541-3Report Type:Expedited (15-DaCompany Report #WAES 00100081 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Consumer Vioxx PS Merck Research Initial or Prolonged Major Depression Laboratories Div Nausea Merck Co Inc ORAL PO Pulmonary Embolism Zyprexa SS 10 MG/DAILY Sweat Gland Disorder Paxil C Wellbutrin Sr C Date:10/12/00ISR Number: 3595643-1Report Type:Expedited (15-DaCompany Report #US_000745171 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Condition Aggravated Professional Loxitane (Loxapine Lactation Disorder Company Succinate) C Pituitary Tumour Benign Representative Parlodel (Bromocriptine Mesilate) C Date:10/12/00ISR Number: 3595645-5Report Type:Expedited (15-DaCompany Report #US_000950625 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Sexual Abuse Other 24-Jun-2005 12:19 PM Page: 1086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/00ISR Number: 3595646-7Report Type:Expedited (15-DaCompany Report #US_000950610 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Consumer Zyprexa PS Eli Lilly And Co 15 MG/1 AT Initial or Prolonged Hepatic Function Abnormal BEDTIME Hypernatraemia Trazodone C Hypotension Remeron Hypothermia (Mirtazapine) C Mental Impairment Carbamazepine C Date:10/12/00ISR Number: 3595647-9Report Type:Expedited (15-DaCompany Report #US_000950469 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa PS Eli Lilly And Co MON Initial or Prolonged Genital Disorder Male Dilantin (Phenytoin Hydrocele Sodium) C Oedema Klonopin Oedema Peripheral (Clonazepam) C Pain Prolixin Scrotal Infection (Fluphenazine Scrotal Irritation Hydrochloride) C Scrotal Pain Prevacid Scrotal Swelling (Lansoprazole) C Skin Hypertrophy Bupropion C Sleep Apnoea Syndrome Swelling Weight Increased Date:10/12/00ISR Number: 3595649-2Report Type:Expedited (15-DaCompany Report #US_000950267 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Blood Creatinine Professional Effexor (Venlafaxine Other Increased Hydrochloride) C Dialysis Klonopin Food Poisoning (Clonazepam) C Liver Function Test Naprosyn (Naproxen) C Abnormal Imitrex (Sumatriptan Malaise Succinate) C Nausea Renal Tubular Necrosis Vomiting Date:10/13/00ISR Number: 3594930-0Report Type:Expedited (15-DaCompany Report #242293 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Clonopin PS Hoffmann La Roche Other Inc ORAL 0.5 MG DAILY, ORAL Zyprexa (Olanzapine) SS ORAL 20 MG DAILY ORAL 24-Jun-2005 12:19 PM Page: 1087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/00ISR Number: 3594510-7Report Type:Expedited (15-DaCompany Report #242293 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Zyprexa PS 122 DAY Metadona SS 4 DAY Rivotril SS Roche 172 DAY Date:10/16/00ISR Number: 3595562-0Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Olanzapine PS ORAL 15 MG PO Initial or Prolonged Syncope SINGLE DOSE Date:10/17/00ISR Number: 3596649-9Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Citalopram PS 40MG QAM Initial or Prolonged Pleural Effusion Verapmil Sa SS 420MG Required Psychotic Disorder Cyclobenzaprine SS 20MG QHS Intervention to Olanzapine SS 5MG QID Prevent Permanent Temazepam SS 30MG QHS Impairment/Damage Cimetidine SS 300MG BID Divalproex SS 500MG BID Nortriptyline SS 20MG QHS Prochlorperazine SS 10MG QAM Oxycodone/ Apap SS 2 TABS QID PRN Date:10/17/00ISR Number: 3596710-9Report Type:Expedited (15-DaCompany Report #US_001050812 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa PS Eli Lilly And Co UNKNOWN 2.5 MG DAY Drug Effect Decreased UNKNOWN 3 WK Hallucination Humulin-Human Nph Increased Appetite Insulin (Rdna)(Human Muscle Rigidity Insulin (Rdna Origin)) SS UNKNOWN 19 U DAY UNKNOWN Humalog SS 22U/DAY Lescol (Fluvastatin Sodium) C Anti-Hypertensive C Sinemet C Date:10/17/00ISR Number: 3596728-6Report Type:Expedited (15-DaCompany Report #US_000950689 Age:31 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Blood Creatine Phosphokinase Increased Chills Clonic Convulsion Dyspnoea 24-Jun-2005 12:19 PM Page: 1088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Hyperreflexia Hypertension Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Literature Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Nausea Health Venlafaxine C Palpitations Professional Lorazepam C Serotonin Syndrome Sinus Tachycardia Skin Warm Tachypnoea Tremor Vision Blurred Date:10/17/00ISR Number: 3596734-1Report Type:Expedited (15-DaCompany Report #US_001051262 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Acute Health Zyprexa PS Eli Lilly And Co 1 YR Professional Depakote (Valproate Company Semisodium) C Representative Date:10/17/00ISR Number: 3596736-5Report Type:Expedited (15-DaCompany Report #US_001051257 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Psychomotor Hyperactivity Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:10/17/00ISR Number: 3596741-9Report Type:Expedited (15-DaCompany Report #US_000950771 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Convulsion Professional Depakote (Valproate Muscle Rigidity Company Semisodium) C Pneumonia Representative Congentin (Benzatropine Mesilate) C Date:10/17/00ISR Number: 3596746-8Report Type:Expedited (15-DaCompany Report #US_000643152 Age:61 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abscess Initial or Prolonged Bradycardia Other Cardiac Failure Congestive Dementia Alzheimer'S Type Depression Diabetic Ulcer Endocarditis Fall Impaired Healing Implant Site Reaction 24-Jun-2005 12:19 PM Page: 1089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Limb Injury Localised Infection Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Humulin R PS Eli Lilly And Co 110 U/DAY 11 YR Visual Disturbance Prozac (Fluoxetine Weight Decreased Hydrochloride) SS 20 MG/DAY Zyprexa (Olanzapine) SS 5 MG/1 IN THE EVENING Actos (Pioglitazone) C Lithium Carbonate C Restoril (Temazepam) C Digoxin C Lasix (Furosemide) C Vitamin B Complex C Zestril (Lisinopril) C Ambien (Zolpidem Tartrate) C Date:10/17/00ISR Number: 3596747-XReport Type:Expedited (15-DaCompany Report #US_001050900 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS Eli Lilly And Co Other Pulmonary Congestion Professional Haldol (Haloperidol) C Respiratory Failure Risperdal (Risperidone) C Nifedipine C Quetiapine C Diazepam C Naprosyn (Naproxen) C Date:10/17/00ISR Number: 3596749-3Report Type:Expedited (15-DaCompany Report #US_000950685 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acetabulum Fracture Literature Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Initial or Prolonged Ankle Fracture Health Venlafaxine C Confusional State Professional Lorazepam C Disorientation Valproic Acid C Fibula Fracture Clonazepam C Hyperreflexia Trazodone C Injury Liver Function Test Abnormal Pyrexia Respiratory Alkalosis Restlessness Road Traffic Accident Serotonin Syndrome Tachycardia Date:10/17/00ISR Number: 3597034-6Report Type:Expedited (15-DaCompany Report #AU_000902003 Age:59 YR Gender:Male I/FU:F Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Dyspnoea 24-Jun-2005 12:19 PM Page: 1090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lower Respiratory Tract Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 10 MG/IN THE Study EVENING Health Furosemide C Professional Slow-K (Potassium Other Chloride) C Captopril C Losec (Omeprazole) C Digoxin C Warfarin C Date:10/17/00ISR Number: 3597035-8Report Type:Expedited (15-DaCompany Report #EWC000306019 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Company Representative Other Date:10/17/00ISR Number: 3597067-XReport Type:Expedited (15-DaCompany Report #DE_000802894 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Condition Aggravated Health Eosinophilia Professional Hyperhidrosis Other Restlessness Date:10/17/00ISR Number: 3597072-3Report Type:Expedited (15-DaCompany Report #US_001050786 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Suicide Attempt Health Biperiden C Professional Sertraline C Other Date:10/17/00ISR Number: 3597379-XReport Type:Expedited (15-DaCompany Report #GBS001006682 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG IN THE Drowning Health EVENING Professional Paroxetine C Other 24-Jun-2005 12:19 PM Page: 1091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/00ISR Number: 3597382-XReport Type:Expedited (15-DaCompany Report #DE_001003186 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/2 DAY Neutrophil Count Abnormal Health Tavor (Lorazepam) C Professional Radedorm Other (Nitrazepam) C Date:10/20/00ISR Number: 3598930-6Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradykinesia Zyprexa -Olanzapine- Hospitalization - Eye Movement Disorder 10mg Eli Lilly PS Eli Lilly ORAL 10MG QHS ORAL Initial or Prolonged Joint Stiffness Risperdal Required Muscle Rigidity -Risperidone- 2mg Intervention to Neuroleptic Malignant Janssen SS Janssen ORAL 2MG TID ORAL Prevent Permanent Syndrome Impairment/Damage Physical Examination Abnormal Posturing Restlessness Date:10/24/00ISR Number: 3600704-4Report Type:Expedited (15-DaCompany Report #US_001051231 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Pyrexia Professional Adderall C Viral Infection Company Representative Date:10/24/00ISR Number: 3600705-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000004633 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Literature Duragesic PS Alza Corp TRANSDERMAL TRANSD Drug Toxicity Health Codeine (Codeine) SS Professional Sertraline (Sertraline) SS Olanzapine (Olanzapine) SS Bupropion (Amfebutamone) SS Date:10/24/00ISR Number: 3600707-XReport Type:Expedited (15-DaCompany Report #US_000848123 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS Eli Lilly And Co 20 MG/DAY 4 MON Initial or Prolonged Drug Interaction Professional Quetiapine C Dystonia Company Effexor C Pruritus Representative Haloperidol C Vomiting Weight Increased 24-Jun-2005 12:19 PM Page: 1092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/00ISR Number: 3600710-XReport Type:Expedited (15-DaCompany Report #US_001051493 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Embolism Health Zyprexa PS Eli Lilly And Co Phlebitis Professional Company Representative Date:10/24/00ISR Number: 3600712-3Report Type:Expedited (15-DaCompany Report #US_000644157 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 450 MG/DAY Initial or Prolonged Phosphokinase Increased Professional Neurontin Other Hypertension Company (Gabapentin) C Hypophosphataemia Representative Adalat (Nifedipine) C Overdose Estrace (Estradiol) C Rhabdomyolysis Celexa (Citalopram Tachycardia Hydrobromide) C Diphenhydramine C Date:10/24/00ISR Number: 3601097-9Report Type:Expedited (15-DaCompany Report #US_001051509 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional Company Representative Date:10/24/00ISR Number: 3601120-1Report Type:Expedited (15-DaCompany Report #CA_000801817 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Dissociative Disorder Health Morphine C Diverticulum Professional Losec (Omeprazole) C Gastrointestinal Motility Other Pantaloc (Pantaloc) C Disorder Ranitidine C Gastrointestinal Ulcer Prevacid Hyperchlorhydria (Lansoprazole) C Obsessive-Compulsive Amoxicillin C Disorder Biaxin Paranoia (Clarithromycin) C Weight Increased Metronidazole C Ciprofloxacin C Paxil (Paroxetine Hydrochloride) C Apo-Trazodone (Trazodone Hydrochloride) C Apo-Naproxen (Naproxen) C Ms Contin (Morphine Sulfate) C Tylenol W/Codeine No. 3 C Apo-Perphenazine 24-Jun-2005 12:19 PM Page: 1093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Perphenazine) C Apo-Amitriptyline (Amitriptyline Hydrochloride) C Trikacide (Metronidazole) C Statex (Morphine Sulfate) C Doak Oil C Apo-Randitine (Randitine Hydrochloride) C Endocet C Baclofen C Effexor (Venlafaxine Hydrochloride) C Supeudol (Oxycodone Hydrochloride) C Wellbutrin (Amfebutamone Hdyrochloride) C Oxycontin (Oxycodone Hydrochloride) C Moclobemide C Apo-Lorazepam (Lorazepam) C Serzone (Nefazodone Hydrochloride) C Stemetil (Prochlorperazine) C Prepulsid (Cisapride) C Ibuprofen C Date:10/24/00ISR Number: 3601129-8Report Type:Expedited (15-DaCompany Report #AU_001002047 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Blood Uric Acid Increased Study Celebrex (Celecoxib) C Diarrhoea Health Diamicron Gamma-Glutamyltransferase Professional (Gliclazide) C Increased Other Haemoglobin Decreased Leukopenia Pyrexia Thrombocytopenia Vomiting Date:10/24/00ISR Number: 3601130-4Report Type:Expedited (15-DaCompany Report #DE_001003243 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 1094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/00ISR Number: 3601131-6Report Type:Expedited (15-DaCompany Report #DE_001003246 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Vertigo Health Weight Gain Poor Professional White Blood Cell Count Other Decreased Date:10/24/00ISR Number: 3601132-8Report Type:Expedited (15-DaCompany Report #EWC000807564 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Bundle Branch Block Right Study Lithium SS 900 MG/DAY Other Deep Vein Thrombosis Health Lorazepam C Delusion Of Reference Professional Dyspnoea Other Electrocardiogram Abnormal Erotomanic Delusion Escherichia Sepsis Haematocrit Decreased Haemoglobin Decreased Iron Deficiency Anaemia Lung Disorder Mean Cell Volume Decreased Pulmonary Embolism Streptococcal Sepsis Therapeutic Agent Toxicity Date:10/24/00ISR Number: 3601333-9Report Type:Expedited (15-DaCompany Report #US_000846890 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co UNKNOWN 2.5 MG/AT Initial or Prolonged Asthenia Health BEDTIME Colonic Haemorrhage Professional UNKNOWN Dizziness Pepcid (Famotidine) C Faecal Occult Blood Amaryl (Glimepiride) C Positive Atenolol C Fatigue Cordarone Gastritis (Amiodarone Gastrointestinal Hydrochloride) C Angiodysplasia Furosemide C Haematocrit Decreased Evista (Raloxifene Haemoglobin Decreased Hydrochloride) C Lethargy Synthroid Rectal Haemorrhage (Levothyroxine Sedation Sodium) C Prinivil (Lisinopril) C K-Dur (Potassium Chloride) C 24-Jun-2005 12:19 PM Page: 1095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/00ISR Number: 3601373-XReport Type:Expedited (15-DaCompany Report #EWC980801293 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS Eli Lilly And Co 250 MG Initial or Prolonged Attention Literature Deficit/Hyperactivity Health Disorder Professional Depressed Level Of Company Consciousness Representative Dysphagia Intentional Misuse Muscle Disorder Sedation Suicide Attempt Visual Acuity Reduced Date:10/24/00ISR Number: 3601375-3Report Type:Expedited (15-DaCompany Report #GBS000906633 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hallucination, Auditory Health Medication Error Professional Company Representative Date:10/27/00ISR Number: 3603013-2Report Type:Expedited (15-DaCompany Report #US_000848274 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Prozac PS Lilly Research Initial or Prolonged Intracranial Aneurysm Health Laboratories Div Eli Other Medication Error Professional Lilly And Co Overdose Zyprexa (Olanzapine) SS 5 MG/DAY 4 MON Paranoia Klonopin Personality Change (Clonazepam) C Suicidal Ideation Norvasc (Amlodipine Besilate) C Aspirin C Date:10/30/00ISR Number: 3603560-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa (10mg Lilly) PS Lilly ORAL 20MG DAILY PO Glucose Tolerance Zyprexa (5mg Lilly) SS Lilly ORAL 5MG DAILY PO Decreased Glucotrol Xl C Date:10/30/00ISR Number: 3604250-3Report Type:Expedited (15-DaCompany Report #US_001052021 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Professional Serzone (Nefazodone Company Hydrochloride) C Representative Xanax (Alprazolam) C 24-Jun-2005 12:19 PM Page: 1096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/00ISR Number: 3604870-6Report Type:Expedited (15-DaCompany Report #GBS001006751 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Health Professional Company Representative Other Date:10/30/00ISR Number: 3604872-XReport Type:Expedited (15-DaCompany Report #EWC001008244 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Myocardial Infarction Health Temesta (Lorazepam) C Schizophrenia Professional Hygroton Other (Chlortalidone) C Aspirin Cardio (Acetylsalicylic Acid) C Date:10/30/00ISR Number: 3604894-9Report Type:Expedited (15-DaCompany Report #DE_001003278 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 20 MG/ 1 DAY Health Benzodiazepine C Professional Other Date:10/30/00ISR Number: 3604915-3Report Type:Expedited (15-DaCompany Report #GBS001006711 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS Eli Lilly And Co 30 DSG FORM Initial or Prolonged Depressed Level Of Literature Consciousness Health Hypertension Professional Miosis Other Overdose Tachycardia Vomiting Date:10/30/00ISR Number: 3604917-7Report Type:Expedited (15-DaCompany Report #AU_001002122 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Libido Increased Health Betamin(3-(Amino-2,4 Mania Professional -Diiodophenyl) Other -Alanin) C Lithicarb(Lithium Carbonate) C Urimide(Furosemide) C Cogentin (Benzatropine 24-Jun-2005 12:19 PM Page: 1097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Cardiprin (Acetylsalicylic Acid) C Slow-K (Potassium Chloride) C Paxam (Piroxicam) C Date:10/30/00ISR Number: 3604939-6Report Type:Expedited (15-DaCompany Report #EWC000707337 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Abnormal Health Cetirizine Electrocardiogram Qt Professional Hydrochloride C Corrected Interval Company Surmontil Prolonged Representative (Trimipramine) C Other Seresta Forte (Oxazepam) C Livostin (Levocabastine Hydrochloride) C Irgamid (Sulfadicramide) C Importal (Lactitol) C Date:10/30/00ISR Number: 3604941-4Report Type:Expedited (15-DaCompany Report #CA_000801782 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Hospitalization - Accidental Overdose Literature Verapamil C Initial or Prolonged Anuria Health Toradol (Ketorolac Blood Creatinine Professional Tromethamine) C Increased Other Ms Contin (Morphine Blood Culture Positive Sulfate) C Blood Urea Increased Temazepam C Bradycardia Coma Dysphasia Hyperglycaemia Hypotension Leukocytosis Lipase Increased Medication Error Pancreatitis Haemorrhagic Peritonitis Pneumonia Pneumonia Staphylococcal Procedural Site Reaction Pyrexia Renal Impairment Staphylococcal Infection Staphylococcal Sepsis 24-Jun-2005 12:19 PM Page: 1098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/00ISR Number: 3604983-9Report Type:Expedited (15-DaCompany Report #US_001051759 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co 2 MON Health Professional Other Date:10/30/00ISR Number: 3604985-2Report Type:Expedited (15-DaCompany Report #EWC001008274 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Macrocytic Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Professional Other Date:10/30/00ISR Number: 3604987-6Report Type:Expedited (15-DaCompany Report #EWC001008245 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Health Professional Other Date:10/31/00ISR Number: 3604473-3Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Zyprexa 10mg Tablet Other Cerebrovascular Accident Eli Lilly PS Eli Lily ORAL 10MG TABLET Convulsion NOW DOUBLE Delusion ORAL - Dry Mouth Dry Throat Dyspnoea Ejaculation Disorder Haematuria Hallucination Keratoconjunctivitis Sicca Paralysis Sedation Thirst Weight Increased Date:11/03/00ISR Number: 3605936-7Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Zyprexa PS Insomnia 24-Jun-2005 12:19 PM Page: 1099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/00ISR Number: 3606649-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Zyprexa 25mg Qd PS 5 MG AM 20 MG Initial or Prolonged HS Risperdal 5mg Qd SS 2MG AM 3 MG HS Cogentin C Depakote C Ativan C Date:11/03/00ISR Number: 3607214-9Report Type:Expedited (15-DaCompany Report #A014542 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zoloft PS Pfizer Initial or Prolonged Extrapyramidal Disorder Health Pharmaceuticals Inc ORAL 50.00 MG Required Suicidal Ideation Professional TOTAL:DAILY:O Intervention to RAL Prevent Permanent Zyprexa SS Impairment/Damage Rivotril C Nolvadex C Depakine Chrono C Levothyrox C Date:11/06/00ISR Number: 3607794-3Report Type:Expedited (15-DaCompany Report #US_001052564 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Dyspnoea Health Hypertension Professional Oedema Peripheral Other Pain In Extremity Pallor Date:11/06/00ISR Number: 3607796-7Report Type:Expedited (15-DaCompany Report #GBS001006780 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Aggression Health Convulsion Professional Dystonia Other Mood Altered Date:11/06/00ISR Number: 3607799-2Report Type:Expedited (15-DaCompany Report #EWC001008244 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Refusal Of Treatment By Health Temesta (Lorazepam) C Patient Professional Hygroton Other (Chlortalidone) C Aspirin Cardio (Acetylsalicylic Acid) C 24-Jun-2005 12:19 PM Page: 1100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/00ISR Number: 3607801-8Report Type:Expedited (15-DaCompany Report #CA_001002157 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY 2 YR Health Tylenol(Paracetamol) C Professional Lorazepam C Other Date:11/06/00ISR Number: 3607804-3Report Type:Expedited (15-DaCompany Report #CA_001002156 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co 20 MG DAY 2 YR Professional Other Date:11/06/00ISR Number: 3607806-7Report Type:Expedited (15-DaCompany Report #EWC001008300 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Sclerosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Disability Professional Other Date:11/06/00ISR Number: 3607808-0Report Type:Expedited (15-DaCompany Report #EWC001008334 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Sudden Death Health Professional Other Date:11/06/00ISR Number: 3607813-4Report Type:Expedited (15-DaCompany Report #DE_001003284 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Bradycardia Foreign Zyprexa PS Eli Lilly And Co Complications Of Maternal Health Exposure To Therapeutic Professional Drugs Other Congenital Foot Malformation Neonatal Disorder Premature Baby Date:11/06/00ISR Number: 3607814-6Report Type:Expedited (15-DaCompany Report #US_001052507 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Delusion Euphoric Mood Grandiosity Insomnia 24-Jun-2005 12:19 PM Page: 1101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Logorrhoea Mania Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Literature Health Professional Other Date:11/06/00ISR Number: 3607815-8Report Type:Expedited (15-DaCompany Report #EWC001008359 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Urinary Retention Health Mopral(Omeprazole) C Professional Gastro Oesophagial Company Reflux C Representative Other Date:11/06/00ISR Number: 3607816-XReport Type:Expedited (15-DaCompany Report #GBS001006765 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co Health Professional Company Representative Other Date:11/06/00ISR Number: 3607838-9Report Type:Expedited (15-DaCompany Report #US_001052476 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co 5 MG/3 DAY Professional Carafate(Sucralfate) C Nystatin C Zinc Sulfate C Versed (Midazolam Hydrochloride) C Dilaudid (Hydromorphone Hydrochloride) C Peri-Colace C Vitamin C C Prilosec (Omeprazole) C Amantadine C Diflucan (Fluconazole) C Tobramycin C Paxil(Paroxetine Hydrochloride) C Oxandrin (Oxandrolone) C Albumin Human C 24-Jun-2005 12:19 PM Page: 1102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/00ISR Number: 3607839-0Report Type:Expedited (15-DaCompany Report #US97054936A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa PS Eli Lilly And Co 300 MG/DAY Initial or Prolonged Consciousness Professional Prozac (Fluoxetine Required Sedation Hydrochloride) SS 1000 MG/DAY Intervention to Prevent Permanent Impairment/Damage Date:11/06/00ISR Number: 3608035-3Report Type:Expedited (15-DaCompany Report #US_001052115 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa PS Eli Lilly And Co 20 MG/DAY Hallucination, Auditory Stelazine (Trifluoperazine Hydrochloride) C Buspar (Buspirone Hydrochloride) C Date:11/06/00ISR Number: 3608069-9Report Type:Expedited (15-DaCompany Report #US_000848627 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Haemorrhage Professional Adderall C Joint Swelling Company Remeron(Mirtazapine) C Muscle Haemorrhage Representative Risperdal(Risperidon e) C Recombinate (Facto Viii, Recombinant) C Date:11/06/00ISR Number: 3608070-5Report Type:Expedited (15-DaCompany Report #US_000848424 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysuria Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Haematuria Professional Prozac(Fluoxetine Micturition Urgency Hydrochloride) SS 20 MG/1 DAY 6 MON Date:11/06/00ISR Number: 3608199-1Report Type:Expedited (15-DaCompany Report #EWC001008331 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Sudden Death Health Professional Other Date:11/06/00ISR Number: 3608200-5Report Type:Expedited (15-DaCompany Report #EWC001008343 Age:41 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 1103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Bone Marrow Depression Health Tercian Haemoglobin Decreased Professional (Cyamemazine) C Hyperpyrexia Company Xanax (Alprazolam) C Leukopenia Representative Stablon (Tianeptine) C Neutropenia Other Sepsis Skin Infection Date:11/06/00ISR Number: 3623405-5Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Motor Dysfunction Zyprexa PS Date:11/13/00ISR Number: 3610270-5Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Zyrexa (5 Mg Hs & Oedema 1.25mg Bid (Lilly) PS Lilly 1.25MG BID Tongue Disorder 2.5MG HS Prozac C Adderall C Ddavp C Date:11/13/00ISR Number: 3613648-9Report Type:Periodic Company Report #FLUV00299001718 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Luvox PS Solvay Hypersensitivity Pharmaceuticals ORAL UNK DAILY PO Hyperventilation Zyprexa (Olanzapine) SS ORAL UNK DAILY PO Hypokalaemia Vivarin (Caffeine) SS ORAL UNK DAILY PO 20 YR Neck Pain Speech Disorder Tongue Disorder Date:11/14/00ISR Number: 3611464-5Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Cipro PS ORAL CIPRO 500 MG Life-Threatening Therapeutic 30 TABS 15 DAY Face Oedema Zyprexa SS ORAL ZYPREXA 10MG Lethargy 30 TABS Localised Oedema Pulse Absent Respiratory Arrest Sedation Weight Increased 24-Jun-2005 12:19 PM Page: 1104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/00ISR Number: 3611525-0Report Type:Expedited (15-DaCompany Report #US_000847352 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspiration Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Dysphagia Professional Lithium Citrate C Vomiting Company Benadryl Representative (Diphenhydramine Hydrochloride) C Depakote (Valproate Semisodium) C Inderal (Propranolol Hydrochloride) C Prolixin (Fluphenazine Hydrochloride) C Date:11/14/00ISR Number: 3612047-3Report Type:Expedited (15-DaCompany Report #GBS000906633 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Agitation Health Hallucination, Auditory Professional Medication Error Company Skin Discolouration Representative Date:11/15/00ISR Number: 3611739-XReport Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Zyprexa PS ORAL 30MG HS PO Diabetes Mellitus Depakote C Diabetic Ulcer Benadryl C Hyperglycaemia Doxycyline C Ketoacidosis Rocephine C Polyuria Thirst Urinary Incontinence Date:11/15/00ISR Number: 3612198-3Report Type:Expedited (15-DaCompany Report #US_990319499 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Humulin R PS Eli Lilly And Co 5 U/IN THE Initial or Prolonged Diabetes Mellitus MORNING Inadequate Control Humulin-Human Lente Hyperglycaemia Insulin (Rdna) Hypoglycaemia (Human Insulin (Rdna Infection Origin)) SS 22 U/IN THE Injection Site Reaction MORNING Obsessive-Compulsive Iletin-Insulin-Anima Disorder l (Unknown Scar Formulation) Sedation (Insulin, Animal) SS Wound Debridement Zyprexa (Olanzapine) SS 2.5 MG/DAY Klonopin (Clonazepam) C Paxil (Paroxetine 24-Jun-2005 12:19 PM Page: 1105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/15/00ISR Number: 3612433-1Report Type:Expedited (15-DaCompany Report #20001100264 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Prilosec PS Astrazeneca Lp ORAL 20 MG BID PO Initial or Prolonged Neutropenia Other Lepticur SS ORAL 1 QD PO Urinary Retention Zoloft SS ORAL 60 MG QD PO Zyprexa SS ORAL 5 MG QD PO Date:11/15/00ISR Number: 3612462-8Report Type:Expedited (15-DaCompany Report #CA_001002168 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angina Pectoris Foreign Zyprexa PS Eli Lilly And Co 10 MG Blood Sodium Increased Health Metformin C Cardiac Arrest Professional Glyburide C Circulatory Collapse Company Cardizem (Diltiazem Dyspepsia Representative Hydrochloride) C Pain Other Coversyl (Perindopril) C Date:11/15/00ISR Number: 3612546-4Report Type:Expedited (15-DaCompany Report #EWC001008387 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Initial or Prolonged Jaundice Health Temesta (Lorazepam) C Liver Function Test Professional Trazolan (Trazodone Abnormal Other Hydrochloride) C Methadone C Date:11/15/00ISR Number: 3612547-6Report Type:Expedited (15-DaCompany Report #DE_001003373 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa PS Eli Lilly And Co 30 MG DAY Initial or Prolonged Asthenia Health Akineton (Biperiden C-Reactive Protein Professional Hydrochloride) C Increased Other Kreon (Pancreatin) C Hypothermia L-Thyroxin Sedation (Levothyroxine Thyroxine Decreased Sodium) C Dominal Forte (Prothipendyl Hydrochloride) C Diazepam C Renicard C Date:11/15/00ISR Number: 3612550-6Report Type:Expedited (15-DaCompany Report #EWC001008375 Age:42 YR Gender:Female I/FU:I Outcome PT Hospitalization - Bradycardia Initial or Prolonged Electrocardiogram Qt Corrected Interval 24-Jun-2005 12:19 PM Page: 1106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Electrocardiogram Qt Prolonged Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Health Risperidal Professional (Risperidone) C Other Tenox (Temazepam) C Diapam (Diazepam) C Remeron (Mirtazapine) C Zyrtec (Cetirizine Hydrochloride) C Beclonasal (Beclomethasone Dipropionate) C Date:11/15/00ISR Number: 3612551-8Report Type:Expedited (15-DaCompany Report #EWC001008419 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Leukopenia Health Professional Company Representative Other Date:11/15/00ISR Number: 3612552-XReport Type:Expedited (15-DaCompany Report #DE_001103398 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Foreign Zyprexa PS Eli Lilly And Co 2.5 MG DAY Initial or Prolonged Leukopenia Health Isdn C Lymphocyte Count Professional Metoprolol C Increased Other Stilnox (Zolpidem) C Neutropenia Dismenol C Thrombocytopenia Ranitidine C Ass 100 "Ct-Arzneimittel" (Acetylsalicylic Acid) C Lactulose C Beloc-Zoc Mite (Metoprolol Succinate) C Corangin - Slow Release (Isosorbide Mononitrate) C Heparin C Date:11/15/00ISR Number: 3612563-4Report Type:Expedited (15-DaCompany Report #DE_001103383 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 20 MG/IN THE Initial or Prolonged Leukopenia Health EVENING Neutropenia Professional Tavor C Other 24-Jun-2005 12:19 PM Page: 1107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/00ISR Number: 3612677-9Report Type:Expedited (15-DaCompany Report #US_001152674 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Depression Professional Lithium C Hypertriglyceridaemia Zoloft (Sertraline Leukocytosis Hydrochloride) C Mania Klonopin Mood Altered (Clonazepam) C Date:11/15/00ISR Number: 3612679-2Report Type:Expedited (15-DaCompany Report #US_001152844 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Health Zyprexa PS Eli Lilly And Co 20 MG/AT Haematuria Professional BEDTIME Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:11/15/00ISR Number: 3612719-0Report Type:Expedited (15-DaCompany Report #US_001152754 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Delusion Zoloft C Pruritus Remeron C Psychotic Disorder Date:11/17/00ISR Number: 3613226-1Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zyprexa 5mg Eli Lilly & Co PS Eli Lilly & Co BUCCAL 1 TABLET BID BUCCAL Date:11/17/00ISR Number: 3613554-XReport Type:Expedited (15-DaCompany Report #JACGER2000001713 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Haldol PS Rw Johnson Initial or Prolonged Phosphokinase Increased Health Pharmaceutical Body Temperature Professional Research Institute Increased Div Ortho Pharm ORAL MG, DAILY, Chills ORAL Fear Truxa Mutism (Chlorprothixene Neuroleptic Malignant Hydrochloride) SS ORAL MG, DAILY, Syndrome ORAL Stupor Zyprexa (Olanzapine) SS ORAL MG, DAILY, ORAL Ciatyl-Z Acuphase (Zuclopenthixol Acetate) SS INTRAMUSCULAR 150 MG, 1 IN 24-Jun-2005 12:19 PM Page: 1108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 TIME(S), IM SEE IMAGE Fluanxol (Flupentixol Dihydrochloride) SS ORAL MG, DAILY, ORAL Leptilan (Valproate Sodium) C Orfiril (Valproate Sodium) C Date:11/20/00ISR Number: 3614443-7Report Type:Expedited (15-DaCompany Report #US_000848274 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Fluoxetine Hcl PS Lilly Research Initial or Prolonged Injury Health Laboratories Div Eli Other Intracranial Aneurysm Professional Lilly And Co Overdose Zyprexa (Olanzapine) SS 5 MG/DAY 4 MON Paranoia Klonopin Suicidal Ideation (Clonazepam) C Norvasc (Amlodipine Besilate) C Aspirin C Date:11/20/00ISR Number: 3614696-5Report Type:Expedited (15-DaCompany Report #US_001052021 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Professional Serzone (Nefazodone Company Hydrochloride) C Representative Xanax (Alprazolam) C Date:11/20/00ISR Number: 3614697-7Report Type:Expedited (15-DaCompany Report #US_000949769 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS Eli Lilly And Co Dry Mouth Aspirin C Dry Throat Haematuria Hypersomnia Keratoconjunctivitis Sicca Nasal Discomfort Renal Colic Sedation Spermatorrhoea Thirst Weight Increased Date:11/20/00ISR Number: 3614717-XReport Type:Periodic Company Report #AU_001102219 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Neutropenia Foreign Health 24-Jun-2005 12:19 PM Page: 1109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 20 MG/DAY Valproate Sodium C Date:11/20/00ISR Number: 3614718-1Report Type:Expedited (15-DaCompany Report #GBS001106896 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Oedema Health Depixol (Flupentixol Oedema Peripheral Professional Decanoate) C Other Chlorpromazine C Priadel (Lithium Carbonate) C Orphenadrine C Fluoxetine C Date:11/20/00ISR Number: 3614721-1Report Type:Expedited (15-DaCompany Report #EWC001108519 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Ulcer Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Keratoconjunctivitis Health Effexor (Venlafaxine Sicca Professional Hydrochloride) C Company Seresta(Oxazepam) C Representative Imovane(Zopiclone) C Other Date:11/20/00ISR Number: 3614722-3Report Type:Expedited (15-DaCompany Report #GBS001106867 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myopathy Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Photophobia Health Chlordiazepoxide C Sedation Professional Temazepam C Other Sanomigran (Pizotifen Maleate) C Tegretol (Carbamazepine) C Seroxat (Paroxetine Hydrochloride) C Zoton (Lansoprazole) C Date:11/20/00ISR Number: 3614723-5Report Type:Expedited (15-DaCompany Report #EWC001108520 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Nozinan Professional (Levomepromazine) C Other Aricept(Donepezil Hydrochloride) C Nitriderm Tts(Glyceryl Trinitrate) C 24-Jun-2005 12:19 PM Page: 1110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3614724-7Report Type:Expedited (15-DaCompany Report #EWC001108521 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Health Lepticur Professional (Tropatepine Other Hydrochloride) C Mopral (Omeprazole) C Zoloft (Sertraline Hydrochloride) C Date:11/20/00ISR Number: 3614727-2Report Type:Expedited (15-DaCompany Report #DE_001103396 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Liver Disorder Health Lithium C Liver Function Test Professional Lyogen Abnormal Other (Fluphenazine) C Date:11/20/00ISR Number: 3614875-7Report Type:Expedited (15-DaCompany Report #US_000848466 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Zyprexa PS Eli Lilly And Co 40 MG/DAY Blood Chloride Increased Professional Prozac(Fluoxetine Brain Oedema Hydrochloride) SS 40 MG/2 DAY Bronchitis Chronic Mellaril(Thioridazin Cardiac Disorder e Hydrochloride) C Coordination Abnormal Cogentin(Benzatropin Drug Toxicity e Mesilate) C Ecchymosis Ferrous Sulfate C Fall Symmetrel(Amantadine Fibrosis Hydrochloride) C Gait Disturbance Hytrin(Terazosin Hepatic Congestion Hydrochloride) C Hyperkalaemia Seroquel C Ketonuria Laceration Meningeal Disorder Muscle Hypertrophy Myocardial Ischaemia Nervous System Disorder Oedema Peripheral Pancreatic Haemorrhage Proteinuria Pulmonary Congestion Pulmonary Oedema Renal Disorder Skin Discolouration Staphylococcal Infection Ventricular Hypertrophy 24-Jun-2005 12:19 PM Page: 1111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3614876-9Report Type:Expedited (15-DaCompany Report #US_000950381 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Nausea Paxil(Paroxetine Pulmonary Embolism Hydrochloride) C Wellbutrin Sr(Amfebutamone Hydrochloride) C Vioxx(Rofecoxib) C Date:11/20/00ISR Number: 3614895-2Report Type:Expedited (15-DaCompany Report #US_981012183 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cystitis Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY Dysphonia Health Zoloft (Sertraline Haematuria Professional Hydrochloride) C Tongue Oedema Weight Decreased Weight Increased Date:11/20/00ISR Number: 3614896-4Report Type:Expedited (15-DaCompany Report #US_001153237 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flatulence Consumer Zyprexa PS Eli Lilly And Co 7.5 MG/AT Food Craving BEDTIME Gait Disturbance Paxil (Paroxetene Haematochezia Hydrochloride) C Muscle Rigidity Sedation Tremor Weight Increased Date:11/20/00ISR Number: 3614898-8Report Type:Expedited (15-DaCompany Report #US_001152798 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Granulomatous Liver Amitriptyline C Disease Estradiol C Liver Function Test Medroxyprogesterone C Abnormal Pyrexia Date:11/20/00ISR Number: 3614903-9Report Type:Expedited (15-DaCompany Report #US_001052140 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Therapeutic Professional Depakote (Valproate Company Semisodium) C Representative Haldol (Haloperidol) C Levaquin (Levofloxacin) C 24-Jun-2005 12:19 PM Page: 1112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3614911-8Report Type:Expedited (15-DaCompany Report #US_001153029 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arterial Occlusive Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Disease Professional Carotid Artery Stenosis Company Representative Date:11/20/00ISR Number: 3615171-4Report Type:Expedited (15-DaCompany Report #CA_000801817 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Dissociative Disorder Health Morphine C Diverticulum Professional Losec(Omeprazole) C Gastric Outlet Other Pantaloc(Pantaloc) C Obstruction Ranitidine C Gastric Ulcer Prevacid(Lansoprazol Gastrointestinal Motility e) C Disorder Amoxicillin C Gastrointestinal Ulcer Biaxin(Clarithromyci Hyperchlorhydria n) C Obsessive-Compulsive Metronidazole C Disorder Ciprofloxacin C Paranoia Paxil(Paroxetine Weight Increased Hydrochloride) C Apo-Trazodone(Trazod one Hydrochloride) C Apo-Naproxen(Naproxe n) C Ms Contin(Morphine Sulfate) C Tylenol W/Codeine No. 3 C Apo-Perphenazine(Per phenazine) C Apo-Amitriptyline(Am itriptyline Hydrochloride) C Trikacide(Metronidaz ole) C Statex(Morphine Sulfate) C Doak Oil C Apo-Ranitidine(Ranit idine Hydrochloride) C Endocet C Baclofen C Effexor(Venlafaxine Hydrochloride) C Supeudol(Oxycodone Hydrochloride) C Wellbutrin(Amfebutam one Hydrochloride) C Supeudol(Oxycodome Hydrochloride) C Moclobemide C Apo-Lorazepame(Loraz epam) C Serzone(Nefazodone 24-Jun-2005 12:19 PM Page: 1113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Stemetil(Prochlorper azine) C Prepulsid(Cisapride) C Ibuprofen C Date:11/20/00ISR Number: 3615172-6Report Type:Expedited (15-DaCompany Report #DE_000802838 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Phosphokinase Increased Health Quilonum - Slow Disability Blood Immunoglobulin E Professional Release(Lithium Increased Other Carbonate) C Diabetic Hyperosmolar Anafranil(Clomiprami Coma ne Hydrochloride) C Fatigue Glucose, Serum C Hyperglycaemia ... C Inflammation Mental Disorder Due To A General Medical Condition Pneumonia Renal Failure Acute Rhabdomyolysis Thirst Date:11/20/00ISR Number: 3615173-8Report Type:Expedited (15-DaCompany Report #EWC000406416 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged C-Reactive Protein Health Imovane(Zopiclone) C Increased Professional Sobril(Oxazepam) C Condition Aggravated Other Antabus(Disulfiram) C Confusional State Nicotine Transdermal Convulsion System(Nicotine Drug Ineffective Resin) C Drug Level Above Therapeutic Dysarthria Hyponatraemia Nausea Neutrophil Count Increased Polydipsia Urinary Tract Infection Vertigo Water Intoxication White Blood Cell Count Increased Date:11/20/00ISR Number: 3615174-XReport Type:Expedited (15-DaCompany Report #EWC001008387 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperbilirubinaemia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Jaundice Health Temesta(Lorazepam) C Liver Function Test Professional Trazolam(Trazodone Abnormal Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Methadone C Cipramil(Citalopram Hydrobromide) C Date:11/20/00ISR Number: 3615283-5Report Type:Expedited (15-DaCompany Report #EWC001008331 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Cerebrovascular Accident Health Ventolin Drug Effect Decreased Professional (Salbutamol) C Sudden Death Other Prozac (Fluoxetine Hydrochloride) C Logastric (Omeprazole) C Loramet (Lormetazepam) C Trazolan (Trazodone Hydrochloride) C Lanitop (Metildigoxin) C Elthyrone (Levothyroxine Sodium) C Sintrom (Acenocoumarol) C Inderal (Propranolol Hydrochloride) C Date:11/20/00ISR Number: 3615289-6Report Type:Expedited (15-DaCompany Report #EWC001008334 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Sudden Death Health Trazolan (Trazodone Professional Hydrochloride) C Other Dafalgan (Paracetamol) C Loramet (Lormetazepam) C Dominal (Prothipendyl Hydrochloride) C Pulmicort (Budesonide) C Serevent (Salmeterol Xinafoate) C Duovent C Ticlid (Ticlopidine Hydrochloride) C Zestril (Lisinopril) C Nitroderm (Glyceryl Trinitrate) C Corvatard (Molsidomine) C 24-Jun-2005 12:19 PM Page: 1115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3615428-7Report Type:Expedited (15-DaCompany Report #US_001052564 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Dyspnoea Health Hypertension Professional Oedema Peripheral Pain In Extremity Pallor Date:11/20/00ISR Number: 3615430-5Report Type:Expedited (15-DaCompany Report #GBS000606174 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Hyperchloraemic Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Initial or Prolonged Apallic Syndrome Health Prozac (Fluoxetine Disability Blood Bilirubin Increased Professional Hydrochloride) SS Other Blood Creatine Other Droperidol C Phosphokinase Increased Mefenamic Acid C Cardiac Arrest Ativan C Dehydration Drug Interaction Electrocardiogram Abnormal Electrocardiogram Qt Prolonged Hyperglycaemia Hypernatraemia Hypocalcaemia Hypoproteinaemia Liver Function Test Abnormal Date:11/20/00ISR Number: 3615443-3Report Type:Expedited (15-DaCompany Report #GBS000706281 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Drug Level Above Health Fluoxetine Therapeutic Professional (Fluoxetine Overdose Other Hydrochloride) SS Carbamazepine C Date:11/20/00ISR Number: 3615460-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000009257 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL 2 MG, 1 IN 1 DAY(S), ORAL Clozaril SS ORAL ORAL Zyprexa SS ORAL ORAL Lorazepam C Benztropine C 24-Jun-2005 12:19 PM Page: 1116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/00ISR Number: 3616215-6Report Type:Periodic Company Report #990447.01 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Consumer Lorazepam PS Mylan Hypoaesthesia Pharmaceuticals Inc ORAL 8 MG Q HS, ORAL Zyprexa Tablets Lilly SS Lilly ORAL 20 MG Q HS, ORAL Multivitamin C Date:11/22/00ISR Number: 3617647-2Report Type:Expedited (15-DaCompany Report #001-0073-M0000440 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Mouth Consumer Dilantin PS Parke Davis Div Initial or Prolonged Epilepsy Warner Lambert Co ORAL 300 MG Extrapyramidal Disorder (DAILY), PER Fall ORAL Foot Fracture Zyprexa(Olanzapine) SS 20 MG (QHS) Grand Mal Convulsion Phenobarbital(Phenob Hallucination arbital) SS ORAL 60 MG Head Injury (DAILY), PER Loss Of Consciousness ORAL Orthostatic Hypotension Luvox(Fluvoxamine Psychotic Disorder Maleate) SS ORAL 25 MG Schizophrenia (DAILY), PER Simple Partial Seizures ORAL Vertigo Valproate(Valproate Bismuth) SS Risperidone(Risperid one) SS Date:11/22/00ISR Number: 3617735-0Report Type:Expedited (15-DaCompany Report #HQ3702115NOV2000 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Ativan PS Wyeth Ayerst Initial or Prolonged Delusion Laboratories ORAL ORAL Disorientation Olanzapine SS ORAL 20 MG, ORAL Hallucination, Auditory Insomnia Irritability Schizophrenia Social Avoidant Behaviour Suspiciousness Date:11/22/00ISR Number: 3624189-7Report Type:Periodic Company Report #US_000541737 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Psyllium C 24-Jun-2005 12:19 PM Page: 1117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/00ISR Number: 3624192-7Report Type:Periodic Company Report #US_000541867 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/ 1 Initial or Prolonged Cardiovascular Disorder Health AT BEDTIME Professional Zoloft C Ecotrin C Vitamin E C Xalatan C Timoptic C Alphagan C Naproxen C Temazepam C Lorazepam C Atenolol C Date:11/27/00ISR Number: 3621810-4Report Type:Periodic Company Report #PHEH2000US00923 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 500 MG ORAL Psychotic Disorder Zyprexa (Olanzapine) (Olanzapine) SS Prozac (Fluoxetine Hydrochloride) C Date:11/27/00ISR Number: 3621848-7Report Type:Periodic Company Report #PHEH2000US01126 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril PS Novartis Hospitalization - Liver Function Test Professional Pharmaceuticals Corp ORAL 500 MG ORAL; Initial or Prolonged Abnormal 300 MG ORAL ; Thrombocytopenia 250 MG ORAL 7 YR Zyprexa (Olanzapine) (Olanzapine) SS 5 MG 11 DAY Trinalin (Congesteze) C Nitrostat (Glyceryl Trinitrate) C Alupent (Orciprenaline Sulfate) C Tagamet (Cimetidine) C Date:11/27/00ISR Number: 3621885-2Report Type:Periodic Company Report #PHEH2000US02851 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG, ORAL 1 DAY Zyprexa (Olanzapine) SS 1 DAY Neurontin C Cogentin C Prolixin C 24-Jun-2005 12:19 PM Page: 1118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622077-3Report Type:Periodic Company Report #PHEH2000US00401 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Health Clozaril PS Novartis Hospitalization - Overdose Professional Pharmaceuticals Corp ORAL 400MG ORAL Initial or Prolonged Pneumonia Aspiration Oxybutynin Respiratory Arrest (Oxybutynin) Salivary Hypersecretion (Oxybutynin) SS ORAL ORAL Sedation Navane (Tiotixene) (Tiotixene) SS ORAL ORAL Propranolol(Proprano lol) SS ORAL ORAL Colace (Docusate Sodium) (Docusate Sodium) SS 1 DAY Vitamin E(Tocopherol) SS 1 DAY Lescol (Fluvastatin Sodium) (Fluvastatin Sodium) Unknown SS 1 DAY Lithium C Olanzapine C Date:11/28/00ISR Number: 3618023-9Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Zyprexa Zydis 10 Mg Tablet PS ORAL 10 MG PO Q HS Date:11/28/00ISR Number: 3618102-6Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Nortriptyline 20mg PS ORAL 20MG PO QHS Initial or Prolonged Pleural Effusion Olanzapine 5mg SS ORAL 5MG PO QD Required Psychotic Disorder Clonazepam C Intervention to Cyclobenzaprine C Prevent Permanent Divalproex C Impairment/Damage Cimetidine C Citalopram C Percocet C Prochlorperazine C Risperidone C Temazepam C Date:11/28/00ISR Number: 3618125-7Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Olanzapine PS 24-Jun-2005 12:19 PM Page: 1119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3618814-4Report Type:Expedited (15-DaCompany Report #DE_000802856 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG / DAY Neutropenia Health Leponex (Clozapine) C Splenomegaly Professional Risperdal Thrombocytopenia Other (Risperidone) C Date:11/29/00ISR Number: 3618839-9Report Type:Expedited (15-DaCompany Report #AU_001102231 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Lower Respiratory Tract Study Noten (Atenolol) C Infection Health Cogentin Pain In Extremity Professional (Benzatropine Sepsis Other Mesilate) C Vomiting Astrix (Acetylsalicylic Acid) C Date:11/29/00ISR Number: 3618849-1Report Type:Expedited (15-DaCompany Report #GBS001106913 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Health Chlorpromazine C Professional Other Date:11/29/00ISR Number: 3618851-XReport Type:Expedited (15-DaCompany Report #GBS001006682 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG IN THE Drowning Health EVENING Professional Paroxetine C Other Date:11/29/00ISR Number: 3618854-5Report Type:Expedited (15-DaCompany Report #GBS000606174 Age:41 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acidosis Hyperchloraemic Initial or Prolonged Apallic Syndrome Disability Blood Bicarbonate Other Decreased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Urea Increased Cardiac Arrest Dehydration Drug Interaction Drug Level Above 24-Jun-2005 12:19 PM Page: 1120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Electrocardiogram Qt Prolonged Hyperglycaemia Report Source Product Role Manufacturer Route Dose Duration Hypernatraemia Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Hypocalcaemia Health Prozac (Fluoxetine Hypogammaglobulinaemia Professional Hydrochloride) SS Hypoproteinaemia Other Droperidol C Mefenamic Acid C Ativan (Lorazepam) C Date:11/29/00ISR Number: 3618862-4Report Type:Expedited (15-DaCompany Report #US_000745343 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS Eli Lilly And Co 25 MG /1 DAY Drug Level Above Professional Lithium C Therapeutic Depakote (Valproate Drug Toxicity Semisodium) C Haldol (Haloperidol) C Clozaril (Clozapine) C Ativan (Lorazepam) C Aspirin C Albuterol C Date:11/29/00ISR Number: 3618875-2Report Type:Expedited (15-DaCompany Report #US_001153629 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS Eli Lilly And Co 25 MG/DAY Initial or Prolonged Colitis Professional Prevacid Other Gastritis (Lansoprazole) C Gastrointestinal Calcium C Haemorrhage Multivitamins Nos Haematochezia (Multivitamins Nos) C Lethargy Date:11/29/00ISR Number: 3619156-3Report Type:Expedited (15-DaCompany Report #GBS001106940 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Bilirubin Increased Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Constipation Health Liver Function Test Professional Abnormal Company White Blood Cell Count Representative Increased Date:11/29/00ISR Number: 3619164-2Report Type:Expedited (15-DaCompany Report #DE_001103445 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 10 DAY Leukopenia Literature Neutropenia Health Pyrexia Professional 24-Jun-2005 12:19 PM Page: 1121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3619166-6Report Type:Expedited (15-DaCompany Report #DE_001103398 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Initial or Prolonged Leukopenia Health Isdn C Thrombocytopenia Professional Metoprolol C Stilnox C Dismenol C Ranitidine C Ct-Arzneimittel C Lactulose C Beloc-Zoc Mite C Corangin - Slow Release C Prophylaxis Of Angina Pectoris C Heparin C Date:11/29/00ISR Number: 3619181-2Report Type:Expedited (15-DaCompany Report #AU_000601436 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/IN THE Health EVENING Professional Alprazolam C Company Caltrate C Representative Endep C Irbesartan C Lopid C Hormone Replacement Therapy C Bricanyl Turbuhaler C Date:11/29/00ISR Number: 3619565-2Report Type:Periodic Company Report #US_000440203 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY 3 WK Ativan (Lorazepam) C Antihypertensive C Date:11/29/00ISR Number: 3619569-XReport Type:Periodic Company Report #US_000440293 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Disorder Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3619572-XReport Type:Periodic Company Report #US_000440321 Age: Gender:Male I/FU:I Outcome PT Report Source Tongue Disorder Health Professional Company 24-Jun-2005 12:19 PM Page: 1122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Clozaril (Clozapine) C Date:11/29/00ISR Number: 3619576-7Report Type:Periodic Company Report #US_000440420 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Visual Disturbance Health Zyprexa PS Eli Lilly And Co 20 MG/1DAY 3 YR Professional Lithium C Zantac (Ranitidine Hydrochloride) C Albuterol C Date:11/29/00ISR Number: 3619579-2Report Type:Periodic Company Report #US_000440479 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co Professional Cogentin (Benzatropine Mesilate) C Colace (Docusate Sodium) C Date:11/29/00ISR Number: 3619583-4Report Type:Periodic Company Report #US_000540589 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypercalcaemia Health Zyprexa PS Eli Lilly And Co 4 MON Professional Neurontin (Gabapentin) C Lasix (Furosemide) C Fosamax (Alendronate Sodium) C Beta Blocking Agnet C Prempro C Date:11/29/00ISR Number: 3619588-3Report Type:Periodic Company Report #US_000540749 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 50 MG/1 DAY Professional Company Representative Date:11/29/00ISR Number: 3619596-2Report Type:Periodic Company Report #US_000540967 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Menstrual Disorder Health Professional Company 24-Jun-2005 12:19 PM Page: 1123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Date:11/29/00ISR Number: 3619605-0Report Type:Periodic Company Report #US_000540985 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 20 MG/ 4 DAY Professional Levoxyl (Levothyroxine Sodium) C Date:11/29/00ISR Number: 3619609-8Report Type:Periodic Company Report #US_000541134 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3619622-0Report Type:Periodic Company Report #US_000541211 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 9 DAY Professional Ambien C Synthroid C Date:11/29/00ISR Number: 3619629-3Report Type:Periodic Company Report #US_000541531 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Infection Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3619630-XReport Type:Periodic Company Report #US_000541546 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS Eli Lilly And Co Petechiae Professional Depakote C Company Representative Date:11/29/00ISR Number: 3619632-3Report Type:Periodic Company Report #US_000542267 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Health Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY Professional Humulin-Human Nph 24-Jun-2005 12:19 PM Page: 1124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin (Rdna) (Human Insulin (Rdna Origin)) SS Isorbid C Glucotrol C Procardia C Betagan C Date:11/29/00ISR Number: 3619633-5Report Type:Periodic Company Report #US_000542291 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/3 WEEK 1 YR Prozac (Fluoxetine Hydrochloride) SS 5 MG / DAY 1 YR Date:11/29/00ISR Number: 3619635-9Report Type:Periodic Company Report #US_000542390 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 40 MG/ 1DAY Professional Company Representative Date:11/29/00ISR Number: 3619636-0Report Type:Periodic Company Report #US_000542398 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Zyprexa PS Eli Lilly And Co 40 MG/1DAY Date:11/29/00ISR Number: 3619638-4Report Type:Periodic Company Report #US_000642819 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3619639-6Report Type:Periodic Company Report #US_000642828 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3619640-2Report Type:Periodic Company Report #US_000642830 Age: Gender:Female I/FU:I Outcome PT Report Source Oedema Health Professional Company 24-Jun-2005 12:19 PM Page: 1125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 15 MG/ 1 DAY Date:11/29/00ISR Number: 3619641-4Report Type:Periodic Company Report #US_000643018 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 3 MON Professional Loxitane C Company Benzylhydrochlorthia Representative zide C Effexor C Ativan C Premphase C Lithium C Date:11/29/00ISR Number: 3619644-XReport Type:Periodic Company Report #US_000643061 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Professional Company Representative Date:11/29/00ISR Number: 3619646-3Report Type:Periodic Company Report #US_000643166 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromosome Abnormality Health Zyprexa PS Eli Lilly And Co Professional Date:11/29/00ISR Number: 3619652-9Report Type:Periodic Company Report #US_000643378 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psoriasis Health Zyprexa PS Eli Lilly And Co Professional Date:11/29/00ISR Number: 3619654-2Report Type:Periodic Company Report #US_000643430 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa PS Eli Lilly And Co 2 YR Professional Date:11/29/00ISR Number: 3619655-4Report Type:Periodic Company Report #US_000643597 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Oedema Health Professional Company 24-Jun-2005 12:19 PM Page: 1126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Date:11/29/00ISR Number: 3619656-6Report Type:Periodic Company Report #US_000643600 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Professional Company Representative Date:11/29/00ISR Number: 3619657-8Report Type:Periodic Company Report #US_000643727 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 70 MG/1 DAY Professional Date:11/29/00ISR Number: 3619658-XReport Type:Periodic Company Report #US_000643852 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Professional Lithium C Company Depakote C Representative Tegretol C Neurontin C Date:11/29/00ISR Number: 3619660-8Report Type:Periodic Company Report #US_000235960 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3619663-3Report Type:Periodic Company Report #US_000235963 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3619665-7Report Type:Periodic Company Report #US_000236121 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Systemic Lupus Health Erythematosus Professional 24-Jun-2005 12:19 PM Page: 1127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Date:11/29/00ISR Number: 3619667-0Report Type:Periodic Company Report #US_000236334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Disorder Health Zyprexa PS Eli Lilly And Co Professional Date:11/29/00ISR Number: 3619668-2Report Type:Periodic Company Report #US_000236403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Health Zyprexa PS Eli Lilly And Co 5 MG AT Professional BEDTIME Company Ambien (Zolpidem Representative Tartrate) C Date:11/29/00ISR Number: 3619673-6Report Type:Periodic Company Report #US_000236406 Age:8 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Health Zyprexa PS Eli Lilly And Co 5 MG AT Professional BEDTIME 7 MON Company Ambien (Zolpidem Representative Tartrate) C Date:11/29/00ISR Number: 3619674-8Report Type:Periodic Company Report #US_000337106 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 35 MG DAY 1 YR Professional Temazepam C Levodopa-Carbidopa C Benztropine C Date:11/29/00ISR Number: 3619675-XReport Type:Periodic Company Report #US_000337430 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa PS Eli Lilly And Co 10 MG/IN THE Professional EVENING 2 WK Date:11/29/00ISR Number: 3619677-3Report Type:Periodic Company Report #US_000337539 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retinal Depigmentation Health Zyprexa PS Eli Lilly And Co 15 MG Professional Celexa (Citalopram Company Hydrobromide) C Representative 24-Jun-2005 12:19 PM Page: 1128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3619679-7Report Type:Periodic Company Report #US_000848141 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Overdose Professional Remeron Company (Mirtazapine) C Representative Klonopin (Clonazepam) C Inderal (Propranolol Hydrochloride) C Date:11/29/00ISR Number: 3619680-3Report Type:Periodic Company Report #US_000848242 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 25 MG 1 DAY 1 YR Professional Depakote (Valproate Semisodium) C Neurontin (Gabapentin) C Symmetrel (Amantadine Hydrochloride) C Klonopin (Clonazepam) C Date:11/29/00ISR Number: 3619684-0Report Type:Periodic Company Report #US_000848249 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Zyprexa PS Eli Lilly And Co 35 MG/1 DAY Date:11/29/00ISR Number: 3619686-4Report Type:Periodic Company Report #US_000848440 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 60 MG/DAY Professional Levoxyl (Levothyroxine Sodium) C Celexa (Citalopram Hydrobromide) C Disulfiram C Quetiapine C Date:11/29/00ISR Number: 3619687-6Report Type:Periodic Company Report #US_000848545 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS Eli Lilly And Co 5 MG/DAY 4 MON Positive Professional Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3619688-8Report Type:Periodic Company Report #US_000848620 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Personality Disorder Consumer Zyprexa PS Eli Lilly And Co 10 MG/2 DAY 3 YR Mellaril (Thioridazine Hydrochloride) C Date:11/29/00ISR Number: 3619689-XReport Type:Periodic Company Report #US_000948984 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 40 MG/DAY Professional Company Representative Date:11/29/00ISR Number: 3619690-6Report Type:Periodic Company Report #US_000949256 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Premature Baby Health Zyprexa PS Eli Lilly And Co Small For Dates Baby Professional Paxil (Paroxetine Hydrochloride) C Date:11/29/00ISR Number: 3619719-5Report Type:Periodic Company Report #US_000949404 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vitiligo Zyprexa PS Eli Lilly And Co 10 MG/DAY Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3619725-0Report Type:Periodic Company Report #US_000949640 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Testicular Disorder Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 1 YR Professional Anafranil (Clomipramine Hydrochloride) C Buspar (Buspirone Hydrochloride) C Klonopin (Clonazepam) C Ritalin (Methylphenidate Hydrochloride) C Date:11/29/00ISR Number: 3619730-4Report Type:Periodic Company Report #US_000950113 Age: Gender:Female I/FU:I Outcome PT Report Source Oedema Health Professional Company 24-Jun-2005 12:19 PM Page: 1130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Date:11/29/00ISR Number: 3619733-XReport Type:Periodic Company Report #US_000950243 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Depakote C Date:11/29/00ISR Number: 3619738-9Report Type:Periodic Company Report #US_000950251 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY 1 MON Flatulence Blood Pressure Medication C Thyroid C Lung Medication C Prednisone C Date:11/29/00ISR Number: 3619744-4Report Type:Periodic Company Report #US_000950296 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Disorder Consumer Zyprexa PS Eli Lilly And Co 7.5 MG/AT BEDTIME 4 YR Zoloft C Date:11/29/00ISR Number: 3619749-3Report Type:Periodic Company Report #US_000950318 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa PS Eli Lilly And Co 2.5 MG/ 1 DAY Professional Exelon C Company Representative Date:11/29/00ISR Number: 3619755-9Report Type:Periodic Company Report #US_000950336 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Colitis Health Zyprexa PS Eli Lilly And Co Hypovitaminosis Professional Red Blood Cell Company Abnormality Representative Date:11/29/00ISR Number: 3619759-6Report Type:Periodic Company Report #US_000950344 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Muscle Twitching Health Professional 24-Jun-2005 12:19 PM Page: 1131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Date:11/29/00ISR Number: 3619764-XReport Type:Periodic Company Report #US_000950356 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Professional Date:11/29/00ISR Number: 3619767-5Report Type:Periodic Company Report #US_000950598 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS Eli Lilly And Co 7.5 MG/ 1 AT Laboratory Test Abnormal Professional BEDTIME Depakote C Risperdal C Adderall C Clonidine C Date:11/29/00ISR Number: 3619784-5Report Type:Periodic Company Report #US_000950749 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 30 MG/DAY/ A Professional FEW MONTHS Date:11/29/00ISR Number: 3619796-1Report Type:Periodic Company Report #US_000235012 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Inappropriate Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Antidiuretic Hormone Professional Zoloft C Secretion Date:11/29/00ISR Number: 3619798-5Report Type:Periodic Company Report #US_000235076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Supraventricular Health Zyprexa PS Eli Lilly And Co Tachycardia Professional Zoloft C Date:11/29/00ISR Number: 3619803-6Report Type:Periodic Company Report #US_000235107 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Steatosis Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Professional Wellbutrin Sr C Doxepin C Diazepam C Ambien C 24-Jun-2005 12:19 PM Page: 1132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3619812-7Report Type:Periodic Company Report #US_000235241 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Professional BEDTIME 2 MON Prozac SS 20 MG/2 DAY 5 YR Date:11/29/00ISR Number: 3619837-1Report Type:Periodic Company Report #US_000235246 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co Professional Date:11/29/00ISR Number: 3619844-9Report Type:Periodic Company Report #US_000235300 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Penis Disorder Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Professional Company Representative Date:11/29/00ISR Number: 3619857-7Report Type:Periodic Company Report #US_000235378 Age:99 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/1 IN Tongue Disorder THE MORNING Zoloft C Lasix C Potassium C Pepcid C Centrum C Date:11/29/00ISR Number: 3619862-0Report Type:Periodic Company Report #US_000235640 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co 20 MG/1 IN Professional THE EVENING Cogentin C Date:11/29/00ISR Number: 3619866-8Report Type:Periodic Company Report #US_000235822 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 1133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623027-6Report Type:Periodic Company Report #US_990522240 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co UNKNOWN 2 DSG FORM 1 Initial or Prolonged Parathyroid Disorder Health AT BEDTIME Schizophreniform Disorder Professional UNKNOWN Placebo SS UNKNOWN 2 DSG FORM 1 IN THE MORNING UNKNOWN Ativan (Lorazepam) C Inderal (Propranolol Hydrochloride) C Pepcid (Famotidine) C Ranitidine C Trazodone C Quetiapine Fumarate C Fluoxetine C Calcium Carbonate C Calcium C Vitamin D C Date:11/29/00ISR Number: 3623029-XReport Type:Periodic Company Report #US_990522667 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co UNKNOWN 5 MG 1 AT Initial or Prolonged Confusional State Health BEDTIME Insomnia Professional UNKNOWN Hyzaar C Aspirin C Date:11/29/00ISR Number: 3623031-8Report Type:Periodic Company Report #US_990522937 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Zyprexa PS Eli Lilly And Co UNKNOWN 3 DSG FORM 1 Initial or Prolonged Hostility Health AT BEDTIME Schizophreniform Disorder Professional UNKNOWN Placebo SS UNKNOWN 1 DSG FIRM 2 DAY UNKNOWN Benadryl (Diphenhydramine Hydrochloride) C Multiple Vitamins C Folic Acid C Thiamine C Amantadine C Benztropine C Haloperidol C Fluphenazine Decanoate C 24-Jun-2005 12:19 PM Page: 1134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623032-XReport Type:Periodic Company Report #US_990623153 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co UNKNOWN 2 DSG FORM Initial or Prolonged Schizophreniform Disorder Health UNKNOWN Professional Placebo SS UNKNOWN 1 DSG FORM 2 DAY UNKNOWN Date:11/29/00ISR Number: 3623039-2Report Type:Periodic Company Report #US_990623310 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Study Zyprexa PS Eli Lilly And Co UNKNOWN 2.5 MG 1 AT Initial or Prolonged Oedema Peripheral Health BEDTIME Urinary Tract Infection Professional UNKNOWN Temazepam C Docusate C Propoxyphene C Date:11/29/00ISR Number: 3623042-2Report Type:Periodic Company Report #US_990623422 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa PS Eli Lilly And Co UNKNOWN 7.5 MG 1 AT Initial or Prolonged Pneumonia Health BEDTIME Urinary Tract Infection Professional UNKNOWN Multivitamins With Iron C Premarin (Estrogens Conjugated) C Paxil (Paroxetine Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Zestril (Lisinopril) C Ferrous Sulfate C Coumadin (Warfarin Sodium) C Tylenol (Paracetamol) C Trazodone C Ensure C Date:11/29/00ISR Number: 3623043-4Report Type:Periodic Company Report #US_990623689 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS Eli Lilly And Co UNKNOWN 1200 MG 1 DAY Initial or Prolonged Coma Professional UNKNOWN Convulsion Company Intentional Misuse Representative Suicide Attempt 24-Jun-2005 12:19 PM Page: 1135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623045-8Report Type:Periodic Company Report #US_990623748 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Zyprexa PS Eli Lilly And Co UNKNOWN 2.5 MG 1 DAY Initial or Prolonged Convulsion Health UNKNOWN Professional Aricept (Donepezil Hydrochloride) C Multivitamin C Date:11/29/00ISR Number: 3623046-XReport Type:Periodic Company Report #US_990623868 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa PS Eli Lilly And Co UNKNOWN 7.5 MG 1 DAY Initial or Prolonged Health UNKNOWN Professional Ginkgo Biloba C B Complex C Date:11/29/00ISR Number: 3623048-3Report Type:Periodic Company Report #US_990623896 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co UNKNOWN 20 MG DAY Initial or Prolonged Depression Health UNKNOWN Emotional Disorder Professional Tylenol Hallucination (Paracetamol) C Hostility Olanzapine C Insomnia Trilafon Personality Disorder (Perphenazine) C Speech Disorder Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3623049-5Report Type:Periodic Company Report #US_000846974 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Malaise Professional Zoloft C Company Buspar C Representative Depakote C Hydrochlorothiazide C Date:11/29/00ISR Number: 3623052-5Report Type:Periodic Company Report #US_000846999 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Zyprexa PS Eli Lilly And Co 20 MG AT Initial or Prolonged Health BEDTIME Professional Aspirin C Valium C 24-Jun-2005 12:19 PM Page: 1136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623053-7Report Type:Periodic Company Report #US_000847003 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional Synthroid C Gemfibrozil C Date:11/29/00ISR Number: 3623055-0Report Type:Periodic Company Report #US_000847042 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Health Aricept C Professional Hytrin C Potassium C Date:11/29/00ISR Number: 3623056-2Report Type:Periodic Company Report #US_000847248 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 3 DSG FORM/1 Initial or Prolonged Health DAY Professional Date:11/29/00ISR Number: 3623057-4Report Type:Periodic Company Report #US_000847271 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Health Zyprexa PS Eli Lilly And Co 12.5 MG/1 DAY 2 WK Professional Wellbutrin C Date:11/29/00ISR Number: 3623059-8Report Type:Periodic Company Report #US_000847390 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS Eli Lilly And Co 250 MG/DAY Initial or Prolonged Coma Professional Lithium C Overdose Neurontin C Date:11/29/00ISR Number: 3623060-4Report Type:Periodic Company Report #US_000847416 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Consumer Zyprexa PS Eli Lilly And Co Hypotension Syncope Date:11/29/00ISR Number: 3623061-6Report Type:Periodic Company Report #US_000847480 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 30 MG/1 AT Initial or Prolonged Overdose Health BEDTIME Disability Suicide Attempt Professional Prozac C Diovan C 24-Jun-2005 12:19 PM Page: 1137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Keflex C Darvon C Tylenol W/Codeine No. 3 C Date:11/29/00ISR Number: 3623063-XReport Type:Periodic Company Report #US_000847502 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co 5 MG/2 DAY 3 WK Emotional Disorder Professional Klonopin C Tegretol C Topamax C Date:11/29/00ISR Number: 3623064-1Report Type:Periodic Company Report #US_000338266 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Zyprexa PS Eli Lilly And Co 2.5 MG 1 AT Initial or Prolonged Dehydration Health BEDTIME Urinary Tract Infection Professional Sinemet Cr C Sinemet C Ambien (Zolpidem Tartrate) C Date:11/29/00ISR Number: 3623066-5Report Type:Periodic Company Report #US_000338297 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Health Glyburide C Professional Imdur (Isosorbide Mononitrate) C Vasotec (Enalapril Maleate) C Lopid (Gemfibrozil) C Celexa (Citalopram Hydrobromide) C Date:11/29/00ISR Number: 3623068-9Report Type:Periodic Company Report #US_000338347 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Zyprexa PS Eli Lilly And Co 1 MG/1 AT Initial or Prolonged Health BEDTIME Professional Depakote (Valproate Semisodium) C Zovirax (Aciclovir) C Prozac (Fluoxetine Hydrochloride) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623070-7Report Type:Periodic Company Report #US_000338374 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS Eli Lilly And Co 70 MG/DAY Initial or Prolonged Overdose Professional Date:11/29/00ISR Number: 3623071-9Report Type:Periodic Company Report #US_000438488 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Professional Methylphenidate C Tegretol (Carbamazepine) C Topamax (Topiramate) C Date:11/29/00ISR Number: 3623073-2Report Type:Periodic Company Report #US_000438591 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Hyponatraemia Professional Asa (Acetylsalicylic Sedation Acid) C Speech Disorder Amaryl (Glimepiride) C Thinking Abnormal Cardizem (Diltiazem Hydrochloride) C Date:11/29/00ISR Number: 3623074-4Report Type:Periodic Company Report #US_000438646 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Zyprexa PS Eli Lilly And Co 6 MG DAY Initial or Prolonged Health Prozac (Fluoxetine Professional Hydrochloride) SS 25 MG DAY Date:11/29/00ISR Number: 3623075-6Report Type:Periodic Company Report #US_000438673 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/1 Initial or Prolonged Coronary Artery Disease Health AT BEDTIME Professional Vitamin E C Celebrex (Celecoxib) C Temazepam C Date:11/29/00ISR Number: 3623077-XReport Type:Periodic Company Report #US_000438759 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Zyprexa PS Eli Lilly And Co 3 DSG FORM Initial or Prolonged Congestive Health Cardura (Doxazosin Professional Mesilate) C Furosemide C Propranolol C Amitriptyline C Ginkgo Biloba C 24-Jun-2005 12:19 PM Page: 1139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Garlic C Papaya C Aspirin C Serevent (Salmeterol Xinapoate) C Date:11/29/00ISR Number: 3623078-1Report Type:Periodic Company Report #US_000438774 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS Eli Lilly And Co 15 MG DAY Initial or Prolonged Dermatitis Professional Zoloft (Sertraline Liver Function Test Company Hydrochloride) C Abnormal Representative Dilantin (Phenytoin Lymphadenopathy Sodium) C Pain Pruritus Pyrexia Date:11/29/00ISR Number: 3623079-3Report Type:Periodic Company Report #US_990826505 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Health Synthroid C Professional Atorvastatin C Date:11/29/00ISR Number: 3623081-1Report Type:Periodic Company Report #US_990826612 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Life-Threatening Cardiac Arrest Health Cogentin C Professional Paxil C Temazepam C Date:11/29/00ISR Number: 3623082-3Report Type:Periodic Company Report #US_990826636 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG /1 DAY Initial or Prolonged Health Tylenol C Professional Date:11/29/00ISR Number: 3623083-5Report Type:Periodic Company Report #US_99082682 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Professional Depakote C Ambien C Reglan C Promethazine C Chlordiazepoxide C Zyrtec C Zithromax C 24-Jun-2005 12:19 PM Page: 1140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623084-7Report Type:Periodic Company Report #US_990827086 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Zyprexa PS Eli Lilly And Co 800 MG DAY Initial or Prolonged Anticholinergic Syndrome Health Arthralgia Professional Depressed Level Of Consciousness Dystonia Electrocardiogram Abnormal Intentional Misuse Myalgia Pyrexia Speech Disorder Date:11/29/00ISR Number: 3623085-9Report Type:Periodic Company Report #US_990827336 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Study Zyprexa PS Eli Lilly And Co 10 MG Other Abnormal Health Ativan C Professional Date:11/29/00ISR Number: 3623087-2Report Type:Periodic Company Report #US_990927510 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG/DAY 1 WK Initial or Prolonged Health Zoloft C Professional Lithobid C Date:11/29/00ISR Number: 3623088-4Report Type:Periodic Company Report #US_990927748 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Study Zyprexa PS Eli Lilly And Co 2.5 MG/ 2 DAY Hospitalization - Haemorrhage Intracranial Health Furosemide C Initial or Prolonged Infection Professional K-Dur C Disability Pneumonia Norvasc C Sepsis Paxil C Urinary Tract Infection Vitamin C C Vitamin E C Aricept C Theragran-M C Pepcid C Jevity C Lotrisone C Bactroban C Aristocort C Date:11/29/00ISR Number: 3623089-6Report Type:Periodic Company Report #US_990927886 Age:37 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 1141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Depression Study Zyprexa PS Eli Lilly And Co 20 MG/1 IN Drug Effect Increased Health THE EVENING Professional Depakote C Bipolar I C Date:11/29/00ISR Number: 3623090-2Report Type:Periodic Company Report #US_990927934 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Initial or Prolonged Hallucination Health Insomnia Professional Date:11/29/00ISR Number: 3623091-4Report Type:Periodic Company Report #US_990927953 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Prozac C Ativan C Date:11/29/00ISR Number: 3623093-8Report Type:Periodic Company Report #US_990927974 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG / 1 DAY Initial or Prolonged Health Lorazepam C Professional Date:11/29/00ISR Number: 3623094-XReport Type:Periodic Company Report #US_990928068 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Professional Aspirin C Premarin C Date:11/29/00ISR Number: 3623095-1Report Type:Periodic Company Report #US_990928129 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS Eli Lilly And Co 200 MG/ 1 DAY Initial or Prolonged Sedation Professional Neurontin C Celexa C Date:11/29/00ISR Number: 3623097-5Report Type:Periodic Company Report #US_990928248 Age: Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Intentional Misuse Health Initial or Prolonged Pyrexia Professional 24-Jun-2005 12:19 PM Page: 1142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 150 MG Date:11/29/00ISR Number: 3623098-7Report Type:Periodic Company Report #US_990928389 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Health Zyprexa C Professional Paxil C Cogentin C Advil C Prenatal C Date:11/29/00ISR Number: 3623101-4Report Type:Periodic Company Report #US_990928639 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Study Zyprexa PS Eli Lilly And Co 2.5 MG/ 1 DAY Hospitalization - Asthenia Health Aricept C Initial or Prolonged Cholelithiasis Professional Denorex C Dementia T-Gel C Aspirin C Timoptic C Multivitamins C Desoximetasone C Antioxidant C Xalatan C Date:11/29/00ISR Number: 3623103-8Report Type:Periodic Company Report #US_990928713 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/ 1 Life-Threatening Pneumonia Health AT BEDTIME Hospitalization - Professional Vaseretic C Initial or Prolonged Zocor C Multiple Vitamins C Nitrostat C Tylenol C Coumadin C Vioxx C Erythromycin Ethylsuccinate C Date:11/29/00ISR Number: 3623104-XReport Type:Periodic Company Report #US_990928755 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Syndrome Professional Other 24-Jun-2005 12:19 PM Page: 1143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623105-1Report Type:Periodic Company Report #US_990928883 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Consumer Zyprexa PS Eli Lilly And Co 20 MG/ 1 AT Convulsion BEDTIME Dry Mouth Dilantin C Orthostatic Hypotension Phenobarbital C Luvox C Date:11/29/00ISR Number: 3623117-8Report Type:Periodic Company Report #US_000847602 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG /AT Initial or Prolonged Health BEDITME Professional Lisinopril C Glucophage(Metformin Hydrochloride) C Glipizide C Date:11/29/00ISR Number: 3623118-XReport Type:Periodic Company Report #US_000847640 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa PS Eli Lilly And Co 20 MG/DAY 6 MON Initial or Prolonged Hyperglycaemia Lithium C Pollakiuria Tegretol (Carbamazepine_) C Klonopin (Clonazepam) C Mellaril (Thioridazine Hydrochloride) C Synthroid (Levothyroxine Sodium) C Prevacid (Lansoprazole) C Claritin (Lorazepam) C Date:11/29/00ISR Number: 3623119-1Report Type:Periodic Company Report #US_000847659 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Literature Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Weight Increased Health Fluoxetine C Professional Venlafaxine C Quetiapine C Date:11/29/00ISR Number: 3623121-XReport Type:Periodic Company Report #US_000847706 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Initial or Prolonged Tremor Professional Quetiapine C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623122-1Report Type:Periodic Company Report #US_000847716 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 20 MG/1 AT Initial or Prolonged Hyperventilation Professional BEDTIME Nausea Company Prolixin Decanoate( Polyuria Representative Fluphenazine Thirst Decanoate) C Weight Increased Neurontin (Gabapentin) C Date:11/29/00ISR Number: 3623124-5Report Type:Periodic Company Report #US_000847720 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623125-7Report Type:Periodic Company Report #US_000847800 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Lorazepam C Trazodone C Vitamin E C Paxil (Paroxetine Hydrochloride) C Monopril(Fosinopril Sodium) C Norvasc (Amlodipine Besilate) C Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3623128-2Report Type:Periodic Company Report #US_000847893 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623129-4Report Type:Periodic Company Report #US_000848036 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Study Zyprexa PS Eli Lilly And Co 10 MG 1 AT Health BEDTIME Professional Haldol (Haloperidol) C Desyrel (Trazodone Hydrochloride) C Depakote (Valproate Semisodium) C Vistaril 24-Jun-2005 12:19 PM Page: 1145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Hydroxyzine Embonate) C Cogentin (Benzatropine Mesilate) C Date:11/29/00ISR Number: 3623131-2Report Type:Periodic Company Report #US_991029962 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Study Zyprexa PS Eli Lilly And Co 5 MG/2 Hypotension Health Peri-Colace C Pulse Absent Professional Zantac(Ranitidine Respiratory Failure Hydrochloride) C Lotrisone C Axid(Nizatidine) C Date:11/29/00ISR Number: 3623132-4Report Type:Periodic Company Report #US_991030012 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Syndrome Professional Depakote(Valproate Company Semisodium) C Representative Date:11/29/00ISR Number: 3623134-8Report Type:Periodic Company Report #US_991030013 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Study Zyprexa PS Eli Lilly And Co 10 MG DAY Health Depakote(Valproate Professional Semisodium) C ... C Date:11/29/00ISR Number: 3623135-XReport Type:Periodic Company Report #US_991030125 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 17.5 MG/1 DAY Initial or Prolonged Drug Dependence Health Depakote(Valproate Professional Semisodium) C Venlafaxine C Valium(Diazepam) C Date:11/29/00ISR Number: 3623137-3Report Type:Periodic Company Report #US_991030245 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Delusion Health Levoxyl(Levothyroxin Paranoia Professional e Sodium) C Ferrous Sulfate C Artificial Tears C Folic Acid C Zantac(Ranitidine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamin C Buspirone C Carbamazepine C Date:11/29/00ISR Number: 3623139-7Report Type:Periodic Company Report #US_991030292 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Depression Health Ranitidine C Sedation Professional Paxil(Paroxetine Hydrochloride) C Alprazolam C Depakote(Valproate Semisodium) C Date:11/29/00ISR Number: 3623140-3Report Type:Periodic Company Report #US_991030338 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Hallucination Health Professional Date:11/29/00ISR Number: 3623142-7Report Type:Periodic Company Report #US_991030347 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Thinking Abnormal Health BEDTIME Professional Date:11/29/00ISR Number: 3623144-0Report Type:Periodic Company Report #US_991030351 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY Vitamin E C Date:11/29/00ISR Number: 3623145-2Report Type:Periodic Company Report #US_991030366 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS Eli Lilly And Co 15 MG Initial or Prolonged Health Restoril (Temazepam) C Professional Ativan(Lorazepam) C Eskalith Cr(Lithium Carbonate) C Depakote(Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 1147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623148-8Report Type:Periodic Company Report #US_000848052 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Tachycardia Professional Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3623149-XReport Type:Periodic Company Report #US_000848182 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 15 MG/ DAY Initial or Prolonged Weight Increased Professional Paxil (Paroxetine Hydrochloride) C Date:11/29/00ISR Number: 3623150-6Report Type:Periodic Company Report #US_000848304 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Consumer Zyprexa PS Eli Lilly And Co 5 MG/ DAY Initial or Prolonged Hypertonia Depakote (Valproate Muscle Spasms Semisodium) C Date:11/29/00ISR Number: 3623151-8Report Type:Periodic Company Report #US_000848421 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 18 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 AT BEDTIME Ativan (Lorazepam) C Date:11/29/00ISR Number: 3623152-XReport Type:Periodic Company Report #US_000848477 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Consumer Zyprexa PS Eli Lilly And Co 10 MG/ DAY 1 YR Gait Disturbance Injury Sedation Syncope Urinary Incontinence Date:11/29/00ISR Number: 3623153-1Report Type:Periodic Company Report #US_000848488 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Health Lorazepam SS Professional 24-Jun-2005 12:19 PM Page: 1148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623154-3Report Type:Periodic Company Report #US_000848527 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 2 WK Professional Company Representative Date:11/29/00ISR Number: 3623155-5Report Type:Periodic Company Report #US_000848605 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 5 MG/ 1 DAY Initial or Prolonged Health Tylenol Professional (Paracetamol) C Date:11/29/00ISR Number: 3623156-7Report Type:Periodic Company Report #US_000948692 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Congestive Professional Prozac (Fluoxetine Libido Decreased Hydrochloride) SS 20 MG/ DAY Valium (Diazepam) C Lamictal (Lamotrigine) C Ziac C Date:11/29/00ISR Number: 3623157-9Report Type:Periodic Company Report #US_000948712 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Neuroleptic Malignant Professional BEDTIME Syndrome Company Zoloft (Sertraline Representative Hydrochloride) C Lithium C Cogentin (Benzatropine Mesilate) C Risperdal (Risperidone) C Date:11/29/00ISR Number: 3623162-2Report Type:Periodic Company Report #US_000746330 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 4 DSG FORM/AT Initial or Prolonged Health BEDTIME Professional Placebo SS 1 DSG FORM/IN THE MORNING Hydrochlorothiazide C Vitamin E C Potassium Chloride C Felodipine C Aspirin C 24-Jun-2005 12:19 PM Page: 1149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623164-6Report Type:Periodic Company Report #US_000846457 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cystitis Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Deafness Prozac SS 20 MG/DAY 7 YR Faecal Incontinence Nortriptyline C Tremor Weight Increased Date:11/29/00ISR Number: 3623165-8Report Type:Periodic Company Report #US_000846526 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Placebo SS Professional Tylenol C Acetaminophen W/Codeine C Beclomethasone C Psyllium C Ranitidine C Trazodone C Date:11/29/00ISR Number: 3623167-1Report Type:Periodic Company Report #US_000846584 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Zyprexa PS Eli Lilly And Co 50 MG/1 IN Initial or Prolonged Suicide Attempt Health THE EVENING Professional Olanzapine SS 6 MG/1 IN THE EVENING Date:11/29/00ISR Number: 3623169-5Report Type:Periodic Company Report #US_000846853 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co 40 MG/1 DAY Overdose Professional Depakote C Company Representative Date:11/29/00ISR Number: 3623171-3Report Type:Periodic Company Report #US_000846890 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG/AT Initial or Prolonged Health BEDTIME Professional Pepcid C Amaryl C Atenolol C Cordarone C Furosemide C Evista C Synthroid C Prinivil C K-Dur C 24-Jun-2005 12:19 PM Page: 1150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623173-7Report Type:Periodic Company Report #US_000846898 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Overdose Professional Date:11/29/00ISR Number: 3623175-0Report Type:Periodic Company Report #US_000846904 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Polyuria Professional Haldol C Thinking Abnormal Company Thirst Representative Weight Increased Date:11/29/00ISR Number: 3623176-2Report Type:Periodic Company Report #US_991030464 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Zyprexa PS Eli Lilly And Co 5 MG /2 DAY Initial or Prolonged Dyspnoea Professional Laam C Other Methadone C Date:11/29/00ISR Number: 3623177-4Report Type:Periodic Company Report #US_000846910 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Health Lortab C Professional Date:11/29/00ISR Number: 3623178-6Report Type:Periodic Company Report #US_991030481 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Health Depakote C Professional Date:11/29/00ISR Number: 3623179-8Report Type:Periodic Company Report #US_000846912 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Study Zyprexa PS Eli Lilly And Co 12 MG/1 DAY Initial or Prolonged Health Fluoxetine SS 25 MG/1 DAY Professional Folic Acid C Vitamin B-6 C Vitamin B12 C Selenium C Betacarotene C Aspirin C Prempro C Soy C Calcium C Magnesium C 24-Jun-2005 12:19 PM Page: 1151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zinc C Calcium And Vitamin D C Iron C Vitamin E C Date:11/29/00ISR Number: 3623180-4Report Type:Periodic Company Report #US_991030486 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Study Zyprexa PS Eli Lilly And Co 2.5 MG/ 1 DAY Hospitalization - Delusion Health Alphagan C Initial or Prolonged Hallucination Professional Aricept C Pneumonia Aspirin C Sepsis Imdur C Urinary Tract Infection Lorazepam C Regulaid C Timolol C Trazodone C Vitamin B12 C Acetaminophen C Florinef C Multivitamin C Remeron C Date:11/29/00ISR Number: 3623181-6Report Type:Periodic Company Report #US_991030494 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 3 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Cogentin C Date:11/29/00ISR Number: 3623182-8Report Type:Periodic Company Report #US_991030520 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Health Zyprexa PS Eli Lilly And Co 30 MG /DAY Initial or Prolonged Dyspnoea Professional Hydrochlorothiazide Hypertonia /Triamterene C Injury Lopressor C Oedema Wellbutrin C Overdose Depakote C Thinking Abnormal Stool Softener C Tremor Urinary Incontinence Weight Increased Date:11/29/00ISR Number: 3623183-XReport Type:Periodic Company Report #US_991233327 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 40 MG/1 IN Initial or Prolonged Health THE MORNING Professional Olanzapine SS 10 MG/1 DAY Aspirin C 24-Jun-2005 12:19 PM Page: 1152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623184-1Report Type:Periodic Company Report #US_991030525 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Hallucination Professional Prozac (Fluoxetine Other Hormone Level Abnormal Hydrochloride) SS 20 MG/DAY Hyperbilirubinaemia Levothyroxine C Hypertension Propranolol C Paranoia Trazodone C Pyrexia Stupor Tachycardia Date:11/29/00ISR Number: 3623185-3Report Type:Periodic Company Report #US_991233406 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Therapeutic Professional Eskalith (Lithium Face Oedema Carbonate) C Oedema Peripheral Renal Failure Acute Vomiting Date:11/29/00ISR Number: 3623186-5Report Type:Periodic Company Report #US_991130583 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Study Zyprexa PS Eli Lilly And Co 25 MG/DAY Health Depakene C Professional Tegretol C Effexor C Date:11/29/00ISR Number: 3623187-7Report Type:Periodic Company Report #US_991233417 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 15 MG Initial or Prolonged Health Diphenhydramine C Professional Loxapine C Benztropine C Lisinopril C Trazodone C Beclomethasone C Salmeterol C Albuterol C Theophylline C Date:11/29/00ISR Number: 3623188-9Report Type:Periodic Company Report #US_000643941 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Study Zyprexa PS Eli Lilly And Co 20 MG 1 AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Theodur "Elan" (Theophylline) C Atrovent 24-Jun-2005 12:19 PM Page: 1153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Ipratropium Bromide) C Asmacort (Triamcinolone Acetonide) C Zoloft (Sertraline Hydrochloride) C Zestril (Lisinopril) C Date:11/29/00ISR Number: 3623189-0Report Type:Periodic Company Report #US_000643950 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Naprosyn (Naproxen) C Professional Date:11/29/00ISR Number: 3623190-7Report Type:Periodic Company Report #US_991130592 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Tenormin C Bacitracin C Neurontin C Levothroid C Tylenol C Diphenhydramine C Maalox C Premarin C Date:11/29/00ISR Number: 3623191-9Report Type:Periodic Company Report #US_000644033 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Consumer Zyprexa PS Eli Lilly And Co 20 MG/1 DAY 10 WK Initial or Prolonged Paranoia Wellbutrin Sedation (Amfebumatone Hydrochloride) C Neurontin (Gabapentin) C Effexor (Venlafaxine Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3623192-0Report Type:Periodic Company Report #US_991130620 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Syndrome Professional Haldol C Company Luvox C Representative 24-Jun-2005 12:19 PM Page: 1154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623193-2Report Type:Periodic Company Report #US_000644309 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY Initial or Prolonged Hyponatraemia Health Tylenol Urinary Tract Infection Professional (Paracetamol) C Trazodone C Keflex (Cephalexin Monohydrate) C Depakote (Valproate Semisodium) C Naprosyn (Naproxen) C Maxzide C Synthroid (Levothyroxine Sodium) C Date:11/29/00ISR Number: 3623194-4Report Type:Periodic Company Report #US_991130652 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 IN Initial or Prolonged Urinary Retention Health THE EVENING Professional Placebo SS 2 MG/ 1 DAY Calcium Carbonate C Date:11/29/00ISR Number: 3623195-6Report Type:Periodic Company Report #US_000644327 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Study Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Health Lisinopril C Professional Lansoprazole C Alprazolam C Date:11/29/00ISR Number: 3623196-8Report Type:Periodic Company Report #US_000644350 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 1 YR Weight Decreased Professional Elavil (Amitriptyline Hydrochloride) C Date:11/29/00ISR Number: 3623197-XReport Type:Periodic Company Report #US_991029681 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 AT Initial or Prolonged Schizophreniform Disorder Health BEDTIME Professional Placebo C 3 MG /DAY Lisinopril C Atenolol C Hydrochlorothiazide C Fluphenazine Decanoate C 24-Jun-2005 12:19 PM Page: 1155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623198-1Report Type:Periodic Company Report #US_991029697 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 15 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 1 DSG FORM/ 2 DAY Divalproex C Date:11/29/00ISR Number: 3623199-3Report Type:Periodic Company Report #US_000744660 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Health Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Dysphagia Professional Cogentin Extrapyramidal Disorder (Benzatropine Gait Disturbance Mesilate) C Hypertonia Lithium C Hypoxia Valproic Acid C Muscle Rigidity Propanolol C Overdose Divalproex Sodium C Thinking Abnormal Amiloride C Urinary Incontinence Sinemet C Lorazepam C Date:11/29/00ISR Number: 3623200-7Report Type:Periodic Company Report #US_991029710 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthralgia Study Zyprexa PS Eli Lilly And Co 25 MG/1 DAY Hospitalization - Injury Health Amaryl C Initial or Prolonged Professional Aricept C Peri-Colace C Furosemide C Lanoxin C Precose C K-Dur C Multivitamin C Zinc Sulfate C Vitamin C C Vitamin E C Imdur C Tylenol C Milk Of Magnesia C Date:11/29/00ISR Number: 3623201-9Report Type:Periodic Company Report #US_000744661 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Study Zyprexa PS Eli Lilly And Co 2.5 MG /1 DAY Hospitalization - Cerebrovascular Accident Health Furosemide C Initial or Prolonged Professional Plavix (Clopidogrel Sulfate) C Norvasc (Amlodipine Besilate) C 24-Jun-2005 12:19 PM Page: 1156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623202-0Report Type:Periodic Company Report #US_000744696 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Syndrome Professional Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3623203-2Report Type:Periodic Company Report #US_991029767 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623204-4Report Type:Periodic Company Report #US_000744799 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY 6 WK Initial or Prolonged Phosphatase Increased Professional Prozac (Fluoxetine Chills Hydrochloride) SS 10 MG/1 DAY 5 YR Dermatitis Dysarthria Hyperglycaemia Hyperhidrosis Hypoaesthesia Oedema Pyrexia Sedation Thirst Date:11/29/00ISR Number: 3623205-6Report Type:Periodic Company Report #US_991029779 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623206-8Report Type:Periodic Company Report #US_991029836 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Weight Increased Professional Prolixin Decanoate C Company Representative Date:11/29/00ISR Number: 3623207-XReport Type:Periodic Company Report #US_991232955 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Study Zyprexa PS Eli Lilly And Co 5 MG Hypoventilation Health Sinus Bradycardia Professional 24-Jun-2005 12:19 PM Page: 1157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623208-1Report Type:Periodic Company Report #US_991029858 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 5 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Date:11/29/00ISR Number: 3623209-3Report Type:Periodic Company Report #US_991029935 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Polyuria Professional Depakote C Thirst Celexa C Vomiting Lamictal C Date:11/29/00ISR Number: 3623210-XReport Type:Periodic Company Report #US_991233043 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 15 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Ativan C Date:11/29/00ISR Number: 3623211-1Report Type:Periodic Company Report #US_991029949 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623212-3Report Type:Periodic Company Report #US_991233109 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Zyprexa PS Eli Lilly And Co 20 MG / 1 AT Initial or Prolonged Health BEDTIME Professional Multivitamins With Iron C Date:11/29/00ISR Number: 3623213-5Report Type:Periodic Company Report #US_991029953 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Professional Date:11/29/00ISR Number: 3623214-7Report Type:Periodic Company Report #US_991233131 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Oedema Peripheral Health Initial or Prolonged Professional Company 24-Jun-2005 12:19 PM Page: 1158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 20 MG/DAY Depakote C Congentin C Date:11/29/00ISR Number: 3623215-9Report Type:Periodic Company Report #US_991233161 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Zyprexa PS Eli Lilly And Co 4 DSG FORM/1 Initial or Prolonged Hostility Health AT BEDTIME Personality Disorder Professional Placebo SS 1 DSG FORM/ 2 DAY Naftifine C Atenolol C Valproic Acid C Clonazepam C Date:11/29/00ISR Number: 3623218-4Report Type:Periodic Company Report #US_991233186 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Hallucination Health Placebo SS Professional Date:11/29/00ISR Number: 3623220-2Report Type:Periodic Company Report #US_991233242 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623222-6Report Type:Periodic Company Report #US_991233282 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Health DAY Professional Aricept C Date:11/29/00ISR Number: 3623225-1Report Type:Periodic Company Report #US_991233289 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/1 Hospitalization - Hallucination Health AT BEDTIME Initial or Prolonged Suicide Attempt Professional Prozac C Ativan C 24-Jun-2005 12:19 PM Page: 1159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623227-5Report Type:Periodic Company Report #US_991233314 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Zyprexa PS Eli Lilly And Co 20 MG / 1 AT Initial or Prolonged Blood Creatine Professional BEDTIME Phosphokinase Increased Lithium C Confusional State Dizziness Hypoxia Pyrexia Rhabdomyolysis Tachycardia Tremor Date:11/29/00ISR Number: 3623231-7Report Type:Periodic Company Report #US_000744901 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa PS Eli Lilly And Co 4DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/1 IN THE MORNING Sulfamethoxazole C Clomipramine C Clonazepam C Acetaminophen C Date:11/29/00ISR Number: 3623232-9Report Type:Periodic Company Report #US_990725290 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Abdomen Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Hospitalization - Injury Health BEDTIME Initial or Prolonged Professional Prozac C Other Eskalith C Pseudoephedrine C Chlorpheniramine C Ibuprofen C Date:11/29/00ISR Number: 3623233-0Report Type:Periodic Company Report #US_000744968 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Zyprexa PS Eli Lilly And Co 6 MG/1 DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG/1 DAY Ibuprofen C Multivitamin C Vitamin E C Vitamin C C 24-Jun-2005 12:19 PM Page: 1160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623234-2Report Type:Periodic Company Report #US_000744972 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Increased Professional Aspartate Company Aminotransferase Representative Increased Depression Date:11/29/00ISR Number: 3623235-4Report Type:Periodic Company Report #US_990725464 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623236-6Report Type:Periodic Company Report #US_990725706 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Mania Professional Prozac (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Prozac (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Lithium C Klonopin C Paxil C Depakote C Cytomel C Navane C Synthroid C Trazodone C Ambien C Tricyclen C Date:11/29/00ISR Number: 3623237-8Report Type:Periodic Company Report #US_000745142 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 2 DAY FORM/1 Initial or Prolonged Health AT BEDTIME Disability Professional Lorazepam C Aspirin C Date:11/29/00ISR Number: 3623238-XReport Type:Periodic Company Report #US_000745166 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS Eli Lilly And Co 15 MG/1 AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Flonase (Fluticasone Propionate) C Estratab (Estrogens Esterified) C 24-Jun-2005 12:19 PM Page: 1161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nutra-Calm C Folic Acid C Black Current Oil C Vitamin B Complex C Milk Of Magnesia C Date:11/29/00ISR Number: 3623240-8Report Type:Periodic Company Report #US-000745181 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Study Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623241-XReport Type:Periodic Company Report #US_990826032 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY Prozac C Albuterol C Ipratroprium Bromide C Glyburide C Lisinoprl C Date:11/29/00ISR Number: 3623242-1Report Type:Periodic Company Report #US_000745193 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Study Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623243-3Report Type:Periodic Company Report #US_000745254 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 6 MG IN THE Initial or Prolonged Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG IN THE EVENTING Date:11/29/00ISR Number: 3623244-5Report Type:Periodic Company Report #US_990826260 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Placebo SS Professional Propranolol C Lorazepam C Trazodone C 24-Jun-2005 12:19 PM Page: 1162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Divalproex C Date:11/29/00ISR Number: 3623245-7Report Type:Periodic Company Report #US_000745277 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Hospitalization - Suicide Attempt Health BEDTIME Initial or Prolonged Professional Date:11/29/00ISR Number: 3623246-9Report Type:Periodic Company Report #US_990826288 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Schizophrenia Health AT BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY Disulfiram C Docusate C Imipramine C Clonazepam C Trazodone C Valproic Acid C Naproxen C Quietapine Fumarate C Clotrimazole C Acetaminophen C Date:11/29/00ISR Number: 3623247-0Report Type:Periodic Company Report #US_000745290 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Zyprexa PS Eli Lilly And Co 3 DSG Initial or Prolonged Convulsion Health FORM/DAY Other Professional Synthroid (Levothyroxine Sodium) C Allopurinol C Ticlopidine C Ziac C Date:11/29/00ISR Number: 3623248-2Report Type:Periodic Company Report #US_990826298 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS Eli Lilly And Co 20 MG Hospitalization - Health Initial or Prolonged Professional Date:11/29/00ISR Number: 3623249-4Report Type:Periodic Company Report #US_990826359 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Depression Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 1163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5 MG/1 AT BEDTIME Lithium C Prozac (Fluoxetine Hydrochloride) C Ibuprofen C Date:11/29/00ISR Number: 3623250-0Report Type:Periodic Company Report #US_990826367 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Health Cogentin C Professional Ativan C Date:11/29/00ISR Number: 3623261-5Report Type:Periodic Company Report #US_991130662 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 AT Initial or Prolonged Psychotic Disorder Health BEDTIME Professional Date:11/29/00ISR Number: 3623262-7Report Type:Periodic Company Report #US_991130670 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Buccoglossal Syndrome Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Prozac (Fluoxetine Company Hydrochloride) C Representative Klonopin (Clonazepam) C Daypro (Oxaprozin) C Date:11/29/00ISR Number: 3623264-0Report Type:Periodic Company Report #US_991130674 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Hospitalization - Pneumonia Aspiration Health Nifedipine C Initial or Prolonged Professional Levothyroxine C Tylenol (Paracetamol) C Maxzide C Paroxetine C Multivitamin C Ferrous Sulfate C 24-Jun-2005 12:19 PM Page: 1164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623265-2Report Type:Periodic Company Report #US_991130733 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY Drug Dependence Cogentin Hormone Level Abnormal (Benzatropine Mesilate) C Date:11/29/00ISR Number: 3623266-4Report Type:Periodic Company Report #US_991130762 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Anxiety Professional Neurontin Coordination Abnormal (Gabapentin) C Dysarthria Euphoric Mood Hostility Muscle Twitching Nervousness Speech Disorder Syncope Tremor Date:11/29/00ISR Number: 3623267-6Report Type:Periodic Company Report #US_991130912 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa PS Eli Lilly And Co 20 MG/1 AT Initial or Prolonged Schizophreniform Disorder Health BEDTIME Other Professional Placebo SS 1 MG/2 DAY Indomethacin C Fosinopril C Clonazepam C Dilantin (Phenytoin Sodium) C Date:11/29/00ISR Number: 3623268-8Report Type:Periodic Company Report #US_991130925 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pneumonia Aspiration Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Hospitalization - Suicide Attempt Health Initial or Prolonged Tachycardia Professional Other Date:11/29/00ISR Number: 3623270-6Report Type:Periodic Company Report #US_991131144 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health Colace (Docusate Professional Sodium) C 24-Jun-2005 12:19 PM Page: 1165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623271-8Report Type:Periodic Company Report #US_991131204 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Pneumonia Health Twocal Hn C Sepsis Professional Aspirin C Buspar (Buspirone Hydrochloride) C Lorazepam C Milk Of Magnesia C Multivitamin C Vitamin C C Zinc Sulfate C Date:11/29/00ISR Number: 3623273-1Report Type:Periodic Company Report #US_991131230 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthropathy Consumer Zyprexa PS Eli Lilly And Co 10 MGD/DAY Deafness Health Prilosec C Oedema Peripheral Professional Depakote C Pain Date:11/29/00ISR Number: 3623274-3Report Type:Periodic Company Report #US_991131271 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa PS Eli Lilly And Co 15 MG / 1 DAY Professional Sinequan C Company Depakote C Representative Date:11/29/00ISR Number: 3623275-5Report Type:Periodic Company Report #US_991131376 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Health Depakote C Professional Synthroid C Prolixin C Date:11/29/00ISR Number: 3623276-7Report Type:Periodic Company Report #US_991131388 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Study Zyprexa PS Eli Lilly And Co 15 MG Depression Health Depakote C Hallucination Professional Ativan C Trazodone C Tagamet C 24-Jun-2005 12:19 PM Page: 1166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623277-9Report Type:Periodic Company Report #US_991131430 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623278-0Report Type:Periodic Company Report #US_991131457 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 1 MG/2 DAY Date:11/29/00ISR Number: 3623279-2Report Type:Periodic Company Report #US_991131554 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Depakote C Prozac C Multivitamin C Date:11/29/00ISR Number: 3623280-9Report Type:Periodic Company Report #US_991131580 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS Eli Lilly And Co 10 MG/ 1 AT Initial or Prolonged Confusional State Professional BEDTIME Dehydration Other Bupropion C Extrapyramidal Disorder Citalopram C Haloperidol C Benztropine C Date:11/29/00ISR Number: 3623281-0Report Type:Periodic Company Report #US_991131622 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co 5 MG /DAY Professional Company Representative Date:11/29/00ISR Number: 3623282-2Report Type:Periodic Company Report #US_991131662 Age:24 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Sedation Professional 24-Jun-2005 12:19 PM Page: 1167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623283-4Report Type:Periodic Company Report #US_991131715 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 15 MG Initial or Prolonged Health Albuterol C Professional Atrovent (Ipratropium Bromide) C Azmacort (Triamcinolone Acetonide) C Lithium C Date:11/29/00ISR Number: 3623284-6Report Type:Periodic Company Report #US_991131839 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Paranoia Other Lorazepam C Personality Disorder Trilafon Schizophreniform Disorder (Perphenazine) C Luvox (Fluvoxamine Maleate) C Risperdal (Risperidone) C Date:11/29/00ISR Number: 3623285-8Report Type:Periodic Company Report #US_991131841 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Study Zyprexa PS Eli Lilly And Co 5 MG AT Health BEDTIME Professional K-Dur (Potassium Chloride) C Lasix (Furosemide) C Verapamil C Tylenol (Paracetamol) C Date:11/29/00ISR Number: 3623286-XReport Type:Periodic Company Report #US_991132108 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health Lorazepam C Other Professional Tylenol (Paracetamol) C Motrin (Ibuprofen) C Date:11/29/00ISR Number: 3623287-1Report Type:Periodic Company Report #US_991132120 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 3 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY 24-Jun-2005 12:19 PM Page: 1168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623288-3Report Type:Periodic Company Report #US_991232224 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Health Zyprexa PS Eli Lilly And Co 20 MG 1 DAY Initial or Prolonged Professional Ativan (Lorazepam) C Date:11/29/00ISR Number: 3623289-5Report Type:Periodic Company Report #US_991232312 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 4 DSG FORM 1 Initial or Prolonged Health AT BEDTIME Professional Date:11/29/00ISR Number: 3623290-1Report Type:Periodic Company Report #US_991232349 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Zyprexa PS Eli Lilly And Co Life-Threatening Congestive Health Zyprexa (Olanzapine) C Hospitalization - Faecaloma Professional Atenolol C Initial or Prolonged Myocardial Infarction Procardia Xl Disability (Nifedipine) C Glyburide C Aricept (Donepezil Hydrochloride) C Date:11/29/00ISR Number: 3623291-3Report Type:Periodic Company Report #US_991232357 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa PS Eli Lilly And Co 20 MG 1 DAY Initial or Prolonged Professional Serzone (Nefazodone Hydrochloride) C Librium (Chlordiazepoxide Hydrochloride) C Date:11/29/00ISR Number: 3623292-5Report Type:Periodic Company Report #US_991232444 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623294-9Report Type:Periodic Company Report #US_991232509 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Life-Threatening Urinary Tract Infection Health Lactulose C Hospitalization - Professional Aspirin C Initial or Prolonged Senokot C Tylenol C Neurontin C 24-Jun-2005 12:19 PM Page: 1169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nitropatch C Date:11/29/00ISR Number: 3623295-0Report Type:Periodic Company Report #US_991232513 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Health Tagamet C Professional Cogentin C Date:11/29/00ISR Number: 3623296-2Report Type:Periodic Company Report #US_991232593 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Professional Tegretol C Date:11/29/00ISR Number: 3623297-4Report Type:Periodic Company Report #US_991232596 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Syndrome Professional Company Representative Date:11/29/00ISR Number: 3623298-6Report Type:Periodic Company Report #US_991232638 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Hostility Health BEDTIME Professional Date:11/29/00ISR Number: 3623299-8Report Type:Periodic Company Report #US_991232661 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Hyperglycaemia Professional Lotensin C Pravachol C Glucophage C Date:11/29/00ISR Number: 3623301-3Report Type:Periodic Company Report #US_991232762 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 5 MG Initial or Prolonged Hostility Health Ricept C Professional Depakote C Zyprexa C Ativan C 24-Jun-2005 12:19 PM Page: 1170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623303-7Report Type:Periodic Company Report #US_991232818 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Professional FEW MONTHS Clonidine C Klonopin C Date:11/29/00ISR Number: 3623305-0Report Type:Periodic Company Report #US_991232835 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa PS Eli Lilly And Co 17.5 MG/1 DAY Initial or Prolonged Convulsion Drug Interaction Date:11/29/00ISR Number: 3623306-2Report Type:Periodic Company Report #US_991232840 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Date:11/29/00ISR Number: 3623308-6Report Type:Periodic Company Report #US_000948751 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clostridium Colitis Study Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Health Depakote C Professional Neurontin C Date:11/29/00ISR Number: 3623310-4Report Type:Periodic Company Report #US_000948765 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Study Zyprexa PS Eli Lilly And Co 15 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Date:11/29/00ISR Number: 3623312-8Report Type:Periodic Company Report #US_000948895 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Study Zyprexa PS Eli Lilly And Co 5 MG /1 DAY Initial or Prolonged Gait Disturbance Health Zoloft C Professional Hytrin C Aricept C Colace C 24-Jun-2005 12:19 PM Page: 1171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623313-XReport Type:Periodic Company Report #US_000948978 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa PS Eli Lilly And Co 15 MG/ IN THE Initial or Prolonged Increased Professional EVENING 3 MON Aspartate Aminotransferase Increased Date:11/29/00ISR Number: 3623315-3Report Type:Periodic Company Report #US_000949040 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 AT Initial or Prolonged Psychotic Disorder Health BEDTIME Professional Fluticasone C Ipratropium Bromide C Albuterol C Beclomethasone C Tegretol C Acetaminophen C Trazodone C Hydroxyzine C Date:11/29/00ISR Number: 3623317-7Report Type:Periodic Company Report #US_000949187 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Depression Professional Cardizem C Lanoxin C Nitroglycerin C Paroxetine C Date:11/29/00ISR Number: 3623319-0Report Type:Periodic Company Report #US_000949240 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Study Zyprexa PS Eli Lilly And Co 20 MG Hospitalization - Ketoacidosis Health Effexor C Initial or Prolonged Renal Failure Acute Professional Lorazepam C Glucotrol C Gemfibrozil C Glucophage C Date:11/29/00ISR Number: 3623320-7Report Type:Periodic Company Report #US_000949295 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Zyprexa PS Eli Lilly And Co 375 MG Initial or Prolonged Intentional Misuse Professional Zoloft C Sedation Suicide Attempt 24-Jun-2005 12:19 PM Page: 1172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623321-9Report Type:Periodic Company Report #US_000949300 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS Eli Lilly And Co 20 MG/ DAY Initial or Prolonged Professional Company Representative Date:11/29/00ISR Number: 3623322-0Report Type:Periodic Company Report #US_000949398 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Health Citracal C Professional Premarin C Allegra C Lorazepam C Ranitidine C Docusate C Valproic Acid C Naproxen C Date:11/29/00ISR Number: 3623323-2Report Type:Periodic Company Report #US_000949566 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 IN Initial or Prolonged Health THE EVENING Professional Effexor (Venlafaxine Hydrochloride) C Xanax (Alprazolam) C Ativan (Lorazepam) C Milk Of Magnesia C Date:11/29/00ISR Number: 3623324-4Report Type:Periodic Company Report #US_000949660 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Study Zyprexa PS Eli Lilly And Co 75 MG/ 1 AT Health BEDTIME Professional Olanzapine SS 6 MG/1 AT BEDTIME Date:11/29/00ISR Number: 3623325-6Report Type:Periodic Company Report #US_000949687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co Syndrome Professional Haloperidol C Company Representative 24-Jun-2005 12:19 PM Page: 1173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623332-3Report Type:Periodic Company Report #US_000949704 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Dyspnoea Professional Cogentin Dystonia (Benzatropine Mesilate) C Propanolol C Ranitidine C Date:11/29/00ISR Number: 3623333-5Report Type:Periodic Company Report #US_000949749 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Health Zyprexa PS Eli Lilly And Co Weight Increased Professional Company Representative Date:11/29/00ISR Number: 3623334-7Report Type:Periodic Company Report #US_000949804 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Placebo SS Professional Lorazepam C Temazepam C Centrum C Vitamin C C Date:11/29/00ISR Number: 3623335-9Report Type:Periodic Company Report #US_000949829 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 15 MG/1 IN Initial or Prolonged Health THE EVENING Professional Oscal (Calcium Carbonate) C Vitamin E C Vitamin B6 C Benadryl (Diphenhydramine Hydrochloride) C Date:11/29/00ISR Number: 3623336-0Report Type:Periodic Company Report #US_000949900 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Confusional State Professional Ultram (Tramadol Grand Mal Convulsion Company Hydrochloride) C Syncope Representative Synthroid (Levothyroxine Sodium) C Sr (Amfebutamone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623338-4Report Type:Periodic Company Report #US_000949920 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY Liver Function Test Neurontin Abnormal (Gabapentin) C Malaise Depakote (Valproate Sedation Semisodium) C Suicide Attempt Paxil (Paroxetine Urinary Incontinence Hydrochloride) C Weight Increased Date:11/29/00ISR Number: 3623339-6Report Type:Periodic Company Report #US_000949967 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Health Oxycodone And Professional Acetaminophen C Allopurinol C Hydrochlorothiazide C Hydroxyzine C Indomethacin C Lansoprazole C Lisinopril C Propranolol C Trazodone C Diltiazem C Warfarin C Date:11/29/00ISR Number: 3623340-2Report Type:Periodic Company Report #US_990217615 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS Eli Lilly And Co 4DSG FORM/1 Initial or Prolonged Psychotic Disorder Health AT BEDTIME Weight Decreased Professional Placebo SS 1 DSG FORM/2 DAY Lisinopril C Lorazepam C Peri-Colace C Albuterol C Theophylline C Date:11/29/00ISR Number: 3623341-4Report Type:Periodic Company Report #US_990217794 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Initial or Prolonged Congestive Health BEDTIME Disability Professional 24-Jun-2005 12:19 PM Page: 1175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623343-8Report Type:Periodic Company Report #US_990218051 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Depression Health Placebo SS 2 MG DAY Professional Vitamin E C Glyburide C Fosinopril C Thiamine C Date:11/29/00ISR Number: 3623344-XReport Type:Periodic Company Report #US_990218057 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Enalapril Maleate W/Hydrochlorotiazide C Potassium Chloride C Salicylic Acid C Bupropion C Propoxyphene Napsylate W/Acetaminophene C Acetaminophen C Covera-Hs (Verapamil Hydrochloride) C Date:11/29/00ISR Number: 3623345-1Report Type:Periodic Company Report #US_990218160 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Initial or Prolonged Dysphagia Health Prozac (Fluoxetine Oesophageal Ulcer Professional Hydrochloride) C Aspirin C Trazodone C Vitamin B12 C Imdur (Isosorbide Mononitrate) C Ferrous Sulfate C Date:11/29/00ISR Number: 3623346-3Report Type:Periodic Company Report #US_990319146 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Zyprexa PS Eli Lilly And Co 7.5 MG DAY Health Effexor (Venlafaxine Professional Hydrochloride) C Mandelamine(Methenam ine Mandelate) C Bisacodyl C Olanzapine C 24-Jun-2005 12:19 PM Page: 1176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623347-5Report Type:Periodic Company Report #US_990319171 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Vasotec (Enalapril Maleate) C Aspirin C Lanoxin(Digoxin) C Imdur (Isosorbide Mononitrate) C Date:11/29/00ISR Number: 3623348-7Report Type:Periodic Company Report #US_990319728 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Initial or Prolonged Professional Lithium C Klonopin (Clonazepam) C Date:11/29/00ISR Number: 3623349-9Report Type:Periodic Company Report #US_990319800 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG/1 IN Initial or Prolonged Health THE MORNING Professional Date:11/29/00ISR Number: 3623350-5Report Type:Periodic Company Report #US_000949974 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Zyprexa PS Eli Lilly And Co 5 MG/ 1 DAY Syncope Cholestyramine Resin C Thinking Abnormal Allegra-D C Motrin (Ibuprofen) C Ultram (Tramadol Hydrochloride) C Depakote (Valproate Semisodium) C Prevacid (Lansoprazole) C Wellbutrin Sr (Amfebutamone Hydrochloride) C Metoprolol C Synthroid (Levothyroxine Sodium) C Imitrex (Sumatriptan Succinate) C Melatonin C Clonazepam C Pseudoephedrine/ Guaifenesin C Luvox (Fluvoxamine Maleate) C 24-Jun-2005 12:19 PM Page: 1177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpheniramine/ Pseudoephedrine C Celebrex (Celecoxib) C Risperdal (Risperidone) C Xenical (Orlistat) C Lotronex C Date:11/29/00ISR Number: 3623351-7Report Type:Periodic Company Report #US_990319808 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS Eli Lilly And Co 17.5 MG/1 AT Initial or Prolonged Psychotic Disorder Health BEDTIME Schizophreniform Disorder Professional Depakote (Valproate Semisodium) C Benztropine C Sudafed (Pseudoephedrine Hydrochloride) C Inderal(Propranolol Hydrochloride) C Tylenol(Paracetamol) C Date:11/29/00ISR Number: 3623352-9Report Type:Periodic Company Report #US_000950087 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 8 WK Hypoglycaemia Professional Trazodone C Date:11/29/00ISR Number: 3623353-0Report Type:Periodic Company Report #US_000950241 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY 2 WK Paxil (Paroxetine Hydrochloride) C Dilantin (Phenytoin Sodium) C Lamictal (Lamotrigine) C Date:11/29/00ISR Number: 3623354-2Report Type:Periodic Company Report #US_000950376 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Initial or Prolonged Syndrome Professional Overdose Company Representative 24-Jun-2005 12:19 PM Page: 1178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623355-4Report Type:Periodic Company Report #US_000950632 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Zyprexa PS Eli Lilly And Co Date:11/29/00ISR Number: 3623356-6Report Type:Periodic Company Report #US_000950643 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Literature Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Depression Health Fluoxetibe Drug Dependence Professional (Fluoxetine Drug Interaction Hydrochloride) SS 40 MG/1 DAY Buspirone C Trazodone C Zolpidem C Mirtazapine C Levothyroxine C Date:11/29/00ISR Number: 3623357-8Report Type:Periodic Company Report #US_000950662 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 10 MG/DAY 2 MON Initial or Prolonged Hyperglycaemia Professional Haldol Depot Laboratory Test Abnormal (Haloperidol Weight Decreased Decanoate) C Date:11/29/00ISR Number: 3623358-XReport Type:Periodic Company Report #US_000950743 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Ativan (Lorazepam) C ... C Date:11/29/00ISR Number: 3623359-1Report Type:Periodic Company Report #US_990319820 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 3 DSG FORM/1 Initial or Prolonged Psychotic Disorder Health DAY Thinking Abnormal Professional Prolixin Decanoate C Diazepam C Zoloft C Benadryl C Docusate C Amlodipine C Lansoprazole C 24-Jun-2005 12:19 PM Page: 1179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623360-8Report Type:Periodic Company Report #US_000950768 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Zyprexa PS Eli Lilly And Co 7.5 MG/ 1 DAY Initial or Prolonged Health Cardizem Cd Professional (Diltiazem Hydrochloride) C Docusate Sodium C Tylenol Extra Strength (Paracetamol) C Ensure Plus C Multivitamins Nos (Multivitamins Nos) C Aricept (Donepezil Hydrochloride) C Date:11/29/00ISR Number: 3623361-XReport Type:Periodic Company Report #US_990420719 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Tylenol C Xalatan C Artificial Tears C Multivitamin C Date:11/29/00ISR Number: 3623362-1Report Type:Periodic Company Report #US_980300184 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Health Lithium C Professional Ativan(Lorazepam) C Date:11/29/00ISR Number: 3623363-3Report Type:Periodic Company Report #US_990420770 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Initial or Prolonged Health Multivitamin C Professional Seborrhea Ointment C Bacitracin C Acetaminophen C Terazosin C Hydrochlorothiazide/ Triamterene C Dosucate C Aloes C Date:11/29/00ISR Number: 3623365-7Report Type:Periodic Company Report #US_990421336 Age: Gender: I/FU:I Outcome PT Report Source Hospitalization - Diabetes Mellitus Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 1180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 3 DSG FORM/1 DAY Tenormin C Depakote C Date:11/29/00ISR Number: 3623367-0Report Type:Periodic Company Report #US_990421366 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS Eli Lilly And Co 4 DSG FORM/1 Initial or Prolonged Hostility Health AT BEDTIME Injury Professional Valproic Acid C Paranoia Docusate Sodium C Personality Disorder Lansoprazole C Schizophreniform Disorder Lorazepam C Therapeutic Multivitamins C Chlorpromazine Hydrochloride C Chlorpromazine Hydrochloride C Olanzipine C Sunscreen C Vitamin B Complex C Fluphenazine C Maalox C Clonazepam C Quetiapine Fumarate C Clotrimazole C Date:11/29/00ISR Number: 3623381-5Report Type:Periodic Company Report #US_990421499 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Study Zyprexa PS Eli Lilly And Co 5 MG Dehydration Health Zantac C Professional Synthroid C Zocor C Sorbitol C Miacalcin C Monopril C Paxil C Buspar C Colace C Lithium C Trental C Percocet C Date:11/29/00ISR Number: 3623382-7Report Type:Periodic Company Report #US_990521654 Age:84 YR Gender:Male I/FU:I Outcome PT Death Agitation Hospitalization - Cardiac Failure Initial or Prolonged Congestive 24-Jun-2005 12:19 PM Page: 1181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hostility Injury Report Source Product Role Manufacturer Route Dose Duration Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Health BEDTIME Professional Oxazepam C Lorazepam C Atenolol C Donepezil C Sertraline C Digoxin C Gabapentin C Dulcolax C Date:11/29/00ISR Number: 3623384-0Report Type:Periodic Company Report #US_990521897 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health DAY Other Professional Nicotine C Chloral Hydrate C Date:11/29/00ISR Number: 3623387-6Report Type:Periodic Company Report #US_990522101 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Health Depakote C Professional Date:11/29/00ISR Number: 3623390-6Report Type:Periodic Company Report #US_990522167 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Decreased Activity Health BEDTIME Dysarthria Professional Coumadin C Fall Digoxin C Speech Disorder Relafen C Vision Blurred Multivitamin C Vomiting Date:11/29/00ISR Number: 3623392-XReport Type:Periodic Company Report #US_000745346 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Syndrome Professional Haldol (Haloperidol) C Company Representative 24-Jun-2005 12:19 PM Page: 1182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623393-1Report Type:Periodic Company Report #US_000745363 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS Eli Lilly And Co 20 MG/1 AT Initial or Prolonged Hostility Professional BEDTIME Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Date:11/29/00ISR Number: 3623394-3Report Type:Periodic Company Report #US_000745390 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Overdose Professional Zocor (Simvastatin) C Company Representative Date:11/29/00ISR Number: 3623399-2Report Type:Periodic Company Report #US_000745447 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Study Zyprexa PS Eli Lilly And Co 3 DSG FORM/ 1 Hospitalization - Infection Health IN THE Initial or Prolonged Pneumonia Professional EVENING Psychotic Disorder Restoril (Temazepam) C Donepezil C Aspirin C Vitamin E C Percocet C Date:11/29/00ISR Number: 3623401-8Report Type:Periodic Company Report #US_000745459 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa PS Eli Lilly And Co 10 MG/ DAY Initial or Prolonged Congestive Professional Dyspnoea Company Oedema Peripheral Representative Date:11/29/00ISR Number: 3623402-XReport Type:Periodic Company Report #US_000745549 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 3 DSG FORM / Initial or Prolonged Depersonalisation Health 1 AT BEDTIME Thinking Abnormal Professional Placebo SS 1 DSG FORM / 2 DAY K-Dur (Potassium Chloride) C Colace (Docusate Sodium) C Nifedipine C Hydrochlorothiazide C Isosorbide Dinitrate C Lisinopril C 24-Jun-2005 12:19 PM Page: 1183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone C Vitamin E C Date:11/29/00ISR Number: 3623404-3Report Type:Periodic Company Report #US_000745565 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 10 MG / 1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 1 MG/2 DAY Fosinopril C Ibuprofen C Milk Of Magnesia C Kaolin / Pectin C Lorazepam C Haloperidol Lactate C Benztropine Mesylate C Aluminium Hydroxide C Date:11/29/00ISR Number: 3623406-7Report Type:Periodic Company Report #US_000745584 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 4 DSG FORM Initial or Prolonged Hallucination Health DAY Professional Placebo SS 4 DSG FORM DAY Date:11/29/00ISR Number: 3623408-0Report Type:Periodic Company Report #US_000745588 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Zyprexa PS Eli Lilly And Co 6 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG AT BEDTIME Aspirin C Date:11/29/00ISR Number: 3623410-9Report Type:Periodic Company Report #US_000745594 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Health Placebo SS 2 MG DAY Professional Insulin Human C Metformin C Date:11/29/00ISR Number: 3623416-XReport Type:Periodic Company Report #US_000745614 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Increased Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 1184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623417-1Report Type:Periodic Company Report #US_000745625 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Weight Increased Professional Ziac C Date:11/29/00ISR Number: 3623418-3Report Type:Periodic Company Report #US_000745629 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Study Zyprexa PS Eli Lilly And Co 15 MG/AT Initial or Prolonged Health BEDTIME Professional Date:11/29/00ISR Number: 3623419-5Report Type:Periodic Company Report #US_000745659 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Study Zyprexa PS Eli Lilly And Co 10 MG/AT Initial or Prolonged Myasthenic Syndrome Health BEDTIME Other Professional Nizatidine SS 150 MG/2 DAY Montelukast C Nasacort C Benztropine C Date:11/29/00ISR Number: 3623420-1Report Type:Periodic Company Report #US_000745675 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hydrocephalus Study Zyprexa PS Eli Lilly And Co ORAL 2 DSG FORM/AT Initial or Prolonged Syncope Health BEDTIME Professional Zantac C Date:11/29/00ISR Number: 3623421-3Report Type:Periodic Company Report #US_000745720 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Consumer Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Mania Paxil C Personality Disorder Date:11/29/00ISR Number: 3623422-5Report Type:Periodic Company Report #US_000745729 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Health Clonidine C Professional Tylenol Extra Strength C 24-Jun-2005 12:19 PM Page: 1185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623423-7Report Type:Periodic Company Report #US_000745743 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyst Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Zantac C Miacalcin C Vitamin E C Vitamin C C Calcium C Gingko Biloba C Date:11/29/00ISR Number: 3623424-9Report Type:Periodic Company Report #US_000745755 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY Myocardial Infarction Health Celebrex C Professional Donepezil Hydrochloride C Imperial Med Plus Nutritional Supplement C Date:11/29/00ISR Number: 3623425-0Report Type:Periodic Company Report #US_000746032 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketoacidosis Health Zyprexa PS Eli Lilly And Co Nausea Professional Vomiting Date:11/29/00ISR Number: 3623426-2Report Type:Periodic Company Report #US_000746043 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Neurosis Professional Other Water Intoxication Date:11/29/00ISR Number: 3623428-6Report Type:Periodic Company Report #US_000746066 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Zyprexa PS Eli Lilly And Co 6 MG/1 DAY Initial or Prolonged Suicide Attempt Health Fluoxetine SS 25 MG/1 DAY Professional Date:11/29/00ISR Number: 3623429-8Report Type:Periodic Company Report #US_000746078 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Study Zyprexa PS Eli Lilly And Co 10 MG/2 DAY 10 WK Initial or Prolonged Depression Health Ativan C Hallucination Professional Cogentin C Insulin Human 24-Jun-2005 12:19 PM Page: 1186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injection, Isophane C Date:11/29/00ISR Number: 3623430-4Report Type:Periodic Company Report #US_000746097 Age:21 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS Eli Lilly And Co Coordination Abnormal Professional Hallucination Tachycardia Date:11/29/00ISR Number: 3623431-6Report Type:Periodic Company Report #US_000746109 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Study Zyprexa PS Eli Lilly And Co 6 MG/1 DAY Health Fluoxetine SS 50 MG/1 DAY Professional Multiple Vitamins C Date:11/29/00ISR Number: 3623433-XReport Type:Periodic Company Report #US_000746110 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 15 MG/AT Initial or Prolonged Health BEDTIME Professional Date:11/29/00ISR Number: 3623434-1Report Type:Periodic Company Report #US_000746126 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 18 MG Initial or Prolonged Health Fluoxetine SS 75 MG Professional Date:11/29/00ISR Number: 3623435-3Report Type:Periodic Company Report #US_000746152 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Placebo SS Professional Date:11/29/00ISR Number: 3623436-5Report Type:Periodic Company Report #US_000746155 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Hyperglycaemia Professional Depakote C Other Company Synthroid C Representative Tegretol C 24-Jun-2005 12:19 PM Page: 1187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623437-7Report Type:Periodic Company Report #US_000746204 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623776-XReport Type:Periodic Company Report #US_000235186 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Health Zyprexa PS Eli Lilly And Co 2.5 MG / 1 AT Initial or Prolonged Sedation Professional BEDTIME 1 DAY Company Propulsid C Representative Date:11/29/00ISR Number: 3623781-3Report Type:Periodic Company Report #US_000235192 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Diovan C Amaryl C Tricor C Anaprox C Aspirin C Date:11/29/00ISR Number: 3623800-4Report Type:Periodic Company Report #US_000542604 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Study Zyprexa PS Eli Lilly And Co 3 DSG FORM Initial or Prolonged Health Accupril (Quinapril Professional Hydrochloride) C Date:11/29/00ISR Number: 3623802-8Report Type:Periodic Company Report #US_000642720 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY Initial or Prolonged Date:11/29/00ISR Number: 3623805-3Report Type:Periodic Company Report #US_0002355223 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623808-9Report Type:Periodic Company Report #US_000235274 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623810-7Report Type:Periodic Company Report #US_000642784 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Initial or Prolonged Gait Disturbance Professional Sedation Company Representative Date:11/29/00ISR Number: 3623811-9Report Type:Periodic Company Report #US_000642800 Age:68 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Initial or Prolonged Professional Company Representative Date:11/29/00ISR Number: 3623812-0Report Type:Periodic Company Report #US_000642807 Age:78 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Initial or Prolonged Professional Company Representative Date:11/29/00ISR Number: 3623813-2Report Type:Periodic Company Report #US_000235283 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623814-4Report Type:Periodic Company Report #US_000642808 Age:80 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Initial or Prolonged Professional Company Representative 24-Jun-2005 12:19 PM Page: 1189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623815-6Report Type:Periodic Company Report #US_000642899 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Study Zyprexa PS Eli Lilly And Co 1 DSG FORM / Initial or Prolonged Gastrointestinal Disorder Health 1 DAY Professional Asacol (Mesalazine) C Advil (Ibuprofen0 C Date:11/29/00ISR Number: 3623816-8Report Type:Periodic Company Report #US_000235312 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Study Zyprexa PS Eli Lilly And Co 40 MG/ 1 AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Dilantin C Date:11/29/00ISR Number: 3623817-XReport Type:Periodic Company Report #US_000642931 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Date:11/29/00ISR Number: 3623818-1Report Type:Periodic Company Report #US_000235468 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/ 1 Initial or Prolonged Health IN THE Professional EVENING Adalat C Lipitor C Aspirin C Xalatan C Zoloft C Lorazepam C Alphagan C Date:11/29/00ISR Number: 3623819-3Report Type:Periodic Company Report #US_000235509 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Initial or Prolonged Schizophrenia Professional Date:11/29/00ISR Number: 3623820-XReport Type:Periodic Company Report #US_000235535 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 5 MG / 1 AT Initial or Prolonged Health BEDTIME Professional Valtrex C Prilosec C Multivitamin C 24-Jun-2005 12:19 PM Page: 1190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623821-1Report Type:Periodic Company Report #US_000235628 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Study Zyprexa PS Eli Lilly And Co 5 MG/ 1 DAY Initial or Prolonged Cardiac Failure Health Humulin N C Congestive Professional Metoprolol Tartrate C Chest Pain Clomipramine Lung Disorder Hydrochloride C Rezulin C Ditropan C Benztropine C Avandia C Zyban C Date:11/29/00ISR Number: 3623822-3Report Type:Periodic Company Report #US_000642934 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Study Zyprexa PS Eli Lilly And Co I DSG FORM/1 Initial or Prolonged Cerebral Ischaemia Health AT BEDTIME Disability Gait Disturbance Professional Vitamins C Date:11/29/00ISR Number: 3623823-5Report Type:Periodic Company Report #US_000642940 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Lung Disorder Health IN THE Palpitations Professional EVENING Pyrexia Aspirin C Nasonex (Mometasone Furoate) C Aserobid (Flunisolide) C Vitamin B1 C Triamterene C Dulcolax (Bisacodyl) C Multivitamin C Date:11/29/00ISR Number: 3623825-9Report Type:Periodic Company Report #US_000642957 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Weight Decreased Health BEDTIME Professional Placebo SS 1 DAY FORM/2 DY Lorazepam C Date:11/29/00ISR Number: 3623828-4Report Type:Periodic Company Report #US_000642970 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zyprexa PS Eli Lilly And Co 5MG / 2 DAY 1 MON Convulsion Professional Salivary Hypersecretion Company Syncope Representative 24-Jun-2005 12:19 PM Page: 1191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623830-2Report Type:Periodic Company Report #US_000643136 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Consumer Zyprexa PS Eli Lilly And Co 40 MG/DAY Initial or Prolonged Overdose Luvox (Fluvoxamine Maleate) C Clomipramine C Date:11/29/00ISR Number: 3623831-4Report Type:Periodic Company Report #US_000643248 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Diabetes Mellitus Professional Paxil(Paroxetine Hydrochloride) C Vitamin B12 C Lorazepam C Zestoretic C Lipitor (Atorvastatin) C Glucotrol (Glipizide) C Glocuphage (Metformin Hydrochloride) C Theo-Dur (Theophylline) C Azmacort (Triamcinolone Acetonide) C Elavil C Ventolin C Date:11/29/00ISR Number: 3623834-XReport Type:Periodic Company Report #US_000643266 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Diabetes Mellitus Professional Lithium C Sedation Effexor (Enlafaxine Hydrochloride0 C Klonopin (Clonazepam) C Date:11/29/00ISR Number: 3623835-1Report Type:Periodic Company Report #US_000643291 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Psychotic Disorder Health Celebrex (Celecoxib) C Professional Anusol C Prevacid (Lansoprazole) C Hydrocortisone C Zantac (Ranitidine Hydrochloride) C Milk Of Magnesia C Levothyroxine C 24-Jun-2005 12:19 PM Page: 1192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623837-5Report Type:Periodic Company Report #US_000643357 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Study Zyprexa PS Eli Lilly And Co 15 MG/1 AT Life-Threatening Cerebrovascular Accident Health BEDTIME Hospitalization - Pneumonia Professional Sertraline C Initial or Prolonged Trazodone C Aspirin C Vitamin B12 C Donepezil C Levothyroxine C Vitamin E C Docusate C Psyllium C Simethicone C Date:11/29/00ISR Number: 3623838-7Report Type:Periodic Company Report #US_000643391 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malignant Melanoma Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health IN THE Professional EVENINGS Hytrin (Terazosin Hydrochloride) C Caltrate (Calcium Carbonate) C Multivitamin C Trimethoprim Sufate C Date:11/29/00ISR Number: 3623840-5Report Type:Periodic Company Report #US_000643431 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neck Pain Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Fluoxetine SS 3 DSG FORM Professional DAY Imitrex (Sumatriptan Succinate) C Ativan C Rolaids C Zantac C Tylenol C Aspirin C Contact C Comtrex C Laxative C Anexsia C Relafen C Date:11/29/00ISR Number: 3623841-7Report Type:Periodic Company Report #US_000643485 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Syndrome Professional Lithium C Company Representative 24-Jun-2005 12:19 PM Page: 1193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623843-0Report Type:Periodic Company Report #US_000235653 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Initial or Prolonged Overdose Professional Norvasc (Amlodipine Other Besilate) C Buspar (Buspirone Hydrochloride) C Prilosec (Omeprazole) C Flovent (Fluticasone Propionate) C Date:11/29/00ISR Number: 3623844-2Report Type:Periodic Company Report #US_000643521 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 4 DSG FORM Initial or Prolonged Health Atenolol C Professional Sertraline Hydrochloride C Date:11/29/00ISR Number: 3623845-4Report Type:Periodic Company Report #US_000235666 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 12.5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Clonazepam C Other Erythromycin Stolate C Lamotrigine C Levothyroxine C Kcl-Zyma (Potassium Chloride) C Senna C Multivitamin C Vitamin E C Date:11/29/00ISR Number: 3623846-6Report Type:Periodic Company Report #US_000643532 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS Eli Lilly And Co 20 MG /1 AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Lithium C Ativan(Lorazepam) C Date:11/29/00ISR Number: 3623847-8Report Type:Periodic Company Report #US_000235669 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Suicide Attempt Health Prozac (Fluoxetine Professional Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623848-XReport Type:Periodic Company Report #US_000235710 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa PS Eli Lilly And Co 120 MG/1 DAY Initial or Prolonged Intentional Misuse Date:11/29/00ISR Number: 3623849-1Report Type:Periodic Company Report #US_000643547 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Hospitalization - Rectal Haemorrhage Health Sertraline C Initial or Prolonged Professional Donepezil C Vitamin E C Aspirin C Iron C Dulcolax (Bisacodyl) C Date:11/29/00ISR Number: 3623850-8Report Type:Periodic Company Report #US_000235851 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Study Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Health Folic Acid C Professional Vitamin C C Vitamin E C Multivitamin C Date:11/29/00ISR Number: 3623851-XReport Type:Periodic Company Report #US_000235906 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Suicide Attempt Health Paxil (Paroxetine Professional Hydrochloride) C Depakote (Valproate Semisodium) C Restoril (Temazepam) C Tofranil (Imipramine Hydrochloride) C Trazodone C Theo-Dur (Theophylline) C Hytrin (Terazosin Hydrochloride) C Synthroid (Levothyroxine Sodium) C Septra C Ditropan (Oxybutynin) C Detrol (Tolterodine) C 24-Jun-2005 12:19 PM Page: 1195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623852-1Report Type:Periodic Company Report #US_000643556 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stupor Study Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623853-3Report Type:Periodic Company Report #US_000643665 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Phosphokinase Increased Professional Klonopin Oedema Peripheral (Clonazepam) C Red Blood Cell Zoloft (Sertraline Sedimentation Rate Hydrochloride) C Increased Methadone C Tongue Oedema Date:11/29/00ISR Number: 3623854-5Report Type:Periodic Company Report #US_000236028 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co Hyperglycaemia Professional Stelazine Company (Trifluoperazine Representative Hydrochloride) C Date:11/29/00ISR Number: 3623855-7Report Type:Periodic Company Report #US_000643670 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 12 MG /1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 AT BEDTIME Valium (Diazepam) C Date:11/29/00ISR Number: 3623856-9Report Type:Periodic Company Report #US_000643688 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Health Nizatidine Professional (Nizatidine) SS 150 MG /2 DAY Date:11/29/00ISR Number: 3623857-0Report Type:Periodic Company Report #US_000643728 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS Eli Lilly And Co 17 DSG Initial or Prolonged Sedation Professional FORM/DAY Tachycardia Lithium C 24-Jun-2005 12:19 PM Page: 1196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623858-2Report Type:Periodic Company Report #US_000236050 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Lorazepam C Tenormin (Atenolol) C Prozac (Fluoxetine Hydrochloride) C Colace (Docusate Sodium) C Date:11/29/00ISR Number: 3623859-4Report Type:Periodic Company Report #US_000643740 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Initial or Prolonged Overdose Professional Prozac (Fluoxetine Weight Increased Hydrochloride) SS 40 MG/DAY Date:11/29/00ISR Number: 3623860-0Report Type:Periodic Company Report #US_000236059 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Placebo SS Professional Glipizide C Metformin C Fosinopril C Lithium Carbonate C Date:11/29/00ISR Number: 3623861-2Report Type:Periodic Company Report #US_000643932 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Ativan (Lorazepam) C Proventil (Salbutamol) C Atrovent (Ipratropium Bromide) C Ibuprofen C Vicodin C Date:11/29/00ISR Number: 3623862-4Report Type:Periodic Company Report #US_000236139 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS Eli Lilly And Co 15 MG IN THE Initial or Prolonged Health MORNING Professional Paxil (Paroxetine Hydrochloride) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623863-6Report Type:Periodic Company Report #US_990928957 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Date:11/29/00ISR Number: 3623864-8Report Type:Periodic Company Report #US_000236177 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Professional Anafranil Company (Clomipramine Representative Hydrochloride) C Lortab C Xanax (Alprazolam) C Klonopin (Clonazepam) C Date:11/29/00ISR Number: 3623865-XReport Type:Periodic Company Report #US_990929042 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Depakote (Valproate Semisodium) C Ecotrin (Acetylsalicylic Acid) C Synthroid (Levothyroxine Sodium) C Date:11/29/00ISR Number: 3623866-1Report Type:Periodic Company Report #US_000236358 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS Eli Lilly And Co 7.5 MG/1 AT Health BEDTIME Professional Date:11/29/00ISR Number: 3623867-3Report Type:Periodic Company Report #US_991029284 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/1 Initial or Prolonged Hallucination Health AT BEDTIME Thinking Abnormal Professional Placebo SS 3 DSG FORM Niacin C Gemfibrozil C Docusate Sodium C Trazodone C 24-Jun-2005 12:19 PM Page: 1198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623868-5Report Type:Periodic Company Report #US_000236410 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Health Zyprexa PS Eli Lilly And Co 20 MG/1 IN Initial or Prolonged Hyperglycaemia Professional THE EVENING Other Hyperlipidaemia Company Valproic Acid C Personality Disorder Representative Buspar (Buspirone Polyuria Hydrochloride) C Thirst Weight Decreased Weight Increased Date:11/29/00ISR Number: 3623869-7Report Type:Periodic Company Report #US_991029307 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Life-Threatening Health Lasix (Furosemide) C Hospitalization - Professional Potassium Chloride C Initial or Prolonged Morphine C Coumadin (Warfarin Sodium) C Effexor (Venlafaxine Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Iopidine (Apraclonidine) C Lanoxin (Digoxin) C Prinivil (Lisinopril) C Synthroid (Levothyroxine Sodium) C Vicon Forte C Date:11/29/00ISR Number: 3623870-3Report Type:Periodic Company Report #US_000236484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co Professional Prozac (Fluoxetine Company Hydrochloride) SS Representative Dilantin (Phenytoin Sodium) C Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3623871-5Report Type:Periodic Company Report #US_000236486 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hernia Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Intestinal Obstruction Health Professional 24-Jun-2005 12:19 PM Page: 1199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623872-7Report Type:Periodic Company Report #US_991029408 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Insomnia Health AT BEDTIME Professional Placebo SS 3 DSG FORM/DAY Hydrochlorothiazide C Date:11/29/00ISR Number: 3623873-9Report Type:Periodic Company Report #US_000236517 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Study Zyprexa PS Eli Lilly And Co 5 MG Life-Threatening Sepsis Health Vioxx (Rofecoxib) C Hospitalization - Professional K-Dur (Potassium Initial or Prolonged Chloride) C Maxzide C Acetaminophen C Combivent C Benadryl(Diphenhydra mine Hydrochloride) C Vicon Forte C Vitamin C C Macrondantin (Nitrofurantoin) C Omeprazole C Date:11/29/00ISR Number: 3623874-0Report Type:Periodic Company Report #US_000336610 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Zyprexa PS Eli Lilly And Co 20 MG/1 AT Initial or Prolonged Paranoia Professional BEDTIME Company Prozac (Fluoxetine Representative Hydrochloride) SS 20 MG/DAY Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Date:11/29/00ISR Number: 3623875-2Report Type:Periodic Company Report #US_000336613 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 15 MG DAY Initial or Prolonged Health Ventolin Inhaler Professional (Salbutamol) C Zyrtec (Cetirizine Hydrochloride) C Neurontin (Gabapentin) C Olanzapine C Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 1200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623876-4Report Type:Periodic Company Report #US_991029449 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Zyprexa PS Eli Lilly And Co 2.5 MG Initial or Prolonged Health Prinzide C Professional Feosol (Ferrous Sulfate) C Zocor (Simvastatin) C Centrum C Aricept (Donepezil Hydrochloride) C Altace (Ramipril) C Labetalol C Date:11/29/00ISR Number: 3623877-6Report Type:Periodic Company Report #US_000336614 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Osteomyelitis Study Zyprexa PS Eli Lilly And Co 3 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Paxil (Paroxetine Hydrochloride) C Plavix (Clopidogrel Sulfate) C Lasix (Furosemide) C K-Dur (Potassium Chloride) C Propoxyphene Napsylate W/Acetaminophene C Lsnocin (Digoxin) C Date:11/29/00ISR Number: 3623878-8Report Type:Periodic Company Report #US_000336632 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Study Zyprexa PS Eli Lilly And Co 5 MG Initial or Prolonged Schizophreniform Disorder Health Professional Date:11/29/00ISR Number: 3623879-XReport Type:Periodic Company Report #US_991029523 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Professional Date:11/29/00ISR Number: 3623880-6Report Type:Periodic Company Report #US_000336678 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Placebo SS Professional Lithium C Trazadone C Aspirin C 24-Jun-2005 12:19 PM Page: 1201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623881-8Report Type:Periodic Company Report #US_000336705 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY Increased Professional Neurontin C Aspartate Effexor C Aminotransferase Amantadine C Increased ..... C Hyperbilirubinaemia Jaundice Date:11/29/00ISR Number: 3623882-XReport Type:Periodic Company Report #US_000336710 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/1 Health IN THE Professional MORNING Olanzapine SS 2 DSG FORM/1 AT BEDTIME Date:11/29/00ISR Number: 3623883-1Report Type:Periodic Company Report #US_991029534 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Depression Health Proventil Professional (Salbutamol) C Date:11/29/00ISR Number: 3623884-3Report Type:Periodic Company Report #US_000336715 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3623885-5Report Type:Periodic Company Report #US_000336745 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Ventolin C Date:11/29/00ISR Number: 3623886-7Report Type:Periodic Company Report #US_000336752 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hernia Study Zyprexa PS Eli Lilly And Co 1 DSG FORM Initial or Prolonged Health Synthroid C Professional Adalat C 24-Jun-2005 12:19 PM Page: 1202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623887-9Report Type:Periodic Company Report #US_000336767 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Zyprexa PS Eli Lilly And Co 2 DSG FORM AT Initial or Prolonged Congestive Health BEDTIME Professional Vitamin C C Ecotrin C Glucotrol C Quinine Sulfate C Rezulin C Fosinopril C Date:11/29/00ISR Number: 3623888-0Report Type:Periodic Company Report #US_991029545 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Drug Dependence Health Motrin (Ibuprofen) C Other Injury Professional Norethindrone C Suicide Attempt Prenatal C Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Esgic C Multivitamin C Date:11/29/00ISR Number: 3623889-2Report Type:Periodic Company Report #US_000336784 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health DAY Professional Prempro C Fosamax C Ocuvite C Oscal C Lipitor C Date:11/29/00ISR Number: 3623890-9Report Type:Periodic Company Report #US_000336807 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperlipidaemia Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Ketoacidosis Professional Doxepin C Company Neurontin C Representative Wellbutrin C Date:11/29/00ISR Number: 3623891-0Report Type:Periodic Company Report #US_991029571 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Zyprexa PS Eli Lilly And Co 2 DSG Hospitalization - Suicide Attempt Health FORM/DAY Initial or Prolonged Professional Placebo SS 2 DSG FORM/ 1 AT BEDTIME Depakote (Valproate 24-Jun-2005 12:19 PM Page: 1203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Premarin (Estrogens Conjugated) C Multivitamin C Ativan (Lorazepam) C Aleve (Naproxen Sodium) C Calcium C Date:11/29/00ISR Number: 3623892-2Report Type:Periodic Company Report #US_000336867 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Zyprexa PS Eli Lilly And Co 12 MG Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG Zestril C Ativan C Date:11/29/00ISR Number: 3623941-1Report Type:Periodic Company Report #US_000337726 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa PS Eli Lilly And Co 15 MG/ 1 DAY Initial or Prolonged Weight Increased Company Paxil C Representative Klonopin C Remeron C Lithium C Vicodin C Lasix C Date:11/29/00ISR Number: 3623942-3Report Type:Periodic Company Report #US_000337747 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Syncope Professional Date:11/29/00ISR Number: 3623943-5Report Type:Periodic Company Report #US_000337751 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Zyprexa PS Eli Lilly And Co 10 MG/DAY 10 WK Initial or Prolonged Neurosis Professional Paxil C Personality Disorder Date:11/29/00ISR Number: 3623945-9Report Type:Periodic Company Report #US_000337876 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/2 Initial or Prolonged Health DAY Professional Placebo SS 1 DSG FORM/2 DAY Temazepam C Valproic Acid C 24-Jun-2005 12:19 PM Page: 1204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sertraline C Docusate C Cortisporin Otic Drops C Date:11/29/00ISR Number: 3623947-2Report Type:Periodic Company Report #US_000337893 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/ 1 AT BEDTIME Citalopram C Trazodone C Diclofenac C Folic Acid C Thiamine C Multivitamin C Date:11/29/00ISR Number: 3623948-4Report Type:Periodic Company Report #US_000338050 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Consumer Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Lithium C Date:11/29/00ISR Number: 3623950-2Report Type:Periodic Company Report #US_000338109 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Malaise BEDTIME 10 DAY Tinnitus Date:11/29/00ISR Number: 3623952-6Report Type:Periodic Company Report #US_000338200 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Study Zyprexa PS Eli Lilly And Co 2.5 MG AT Initial or Prolonged Health BEDTIME Professional Felodipine C Isosorbide Dinitrate C Multivitamin C Metoprolol Tartrate C Aspirin C Acetaminophen C Lactulose C Date:11/29/00ISR Number: 3623955-1Report Type:Periodic Company Report #US_000338227 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 2 DSG FORM/2 24-Jun-2005 12:19 PM Page: 1205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY Trazodone C Valproic Acid C Multivitamin C Clonazepam C Ibuprofen C Acetaminophen C Imipramine C Date:11/29/00ISR Number: 3623956-3Report Type:Periodic Company Report #US_000338253 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional Other Company Representative Date:11/29/00ISR Number: 3623981-2Report Type:Periodic Company Report #US_000336933 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa PS Eli Lilly And Co 5 MG Health Placebo SS Professional Aspirin C Glyburide C Insulin C Enalapril C Colace (Docusate Sodium) C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Date:11/29/00ISR Number: 3623982-4Report Type:Periodic Company Report #US_000336946 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Drug Dependence Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG Date:11/29/00ISR Number: 3623983-6Report Type:Periodic Company Report #US_000336957 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Study Zyprexa PS Eli Lilly And Co 20 MG/1 AT Initial or Prolonged Influenza Like Illness Health BEDTIME Lung Disorder Professional 24-Jun-2005 12:19 PM Page: 1206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623984-8Report Type:Periodic Company Report #US_000337003 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 5 MG Initial or Prolonged Encephalopathy Health Baby Aspirin Hallucination Professional (Acetysalicylic Hostility Acid) C Multivitamin C Vitamin E C Ginkgo Biloba C Atrovent (Ipratropium Bromide) C Dulcolax (Bisacodyl) C Ativan (Lorazepam) C Date:11/29/00ISR Number: 3623985-XReport Type:Periodic Company Report #US_000337022 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG / 1 AT Hospitalization - Cardiac Failure Health BEDTIME Initial or Prolonged Congestive Professional Albuterol C Cellulitis Aricept (Donepezil Diabetes Mellitus Hydrochloride) C Lung Disorder Artificial Tears C Pneumonia Aspirin (E.C.) Renal Failure Acute (Acetylsalicylic Acid) C Atrovent (Ipratropium Bromide) C Furosemide C Lanoxin (Digoxin) C Multivitamin C Norvasc (Amlodipine Besilate) C Insulin Novolin 70/30 C Phoslo (Calcium Acetate) C Prinivil (Lisinopril) C Reguloid (Psyllium) C Trazodone C Vitamin C C Vitamin E C Zoloft (Sertraline Hydrochloride) C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Ferrous Sulfate C Colate (Docusate Sodium) C Cortisporin Cream C Hydrocortisone C Azmacort (Triamcinolone 24-Jun-2005 12:19 PM Page: 1207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetonide C Cartia (Acetylsalicylic Acid) C Famvir (Famciclovir) C Cardizem Cd (Diltiazem Hydrochloride) C Hydralazine C K-Dur (Potassium Chloride) C Zaroxolyn (Metolazone) C Epogen (Epoetin Alfa) C Prednisone C Prevacid (Lansoprazole) C Vicodin C Ativan (Lorazepam) C Kayexalate (Sodium Polystyrene Sulfonate) C Glucagon C Lacydrin C Date:11/29/00ISR Number: 3623986-1Report Type:Periodic Company Report #US_000337262 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 2.5 MG DAY Initial or Prolonged Health Trazodone C Professional Vitamin B12 C Labetalol C Vitamin E C Asa (Acetylsalicylic Acid) C Ginkoba (Ginkgo Tree Leaves Exract) C Betacarotene C Date:11/29/00ISR Number: 3623987-3Report Type:Periodic Company Report #US_000337263 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Study Zyprexa PS Eli Lilly And Co 7.5 MG / 1 AT Initial or Prolonged Haemorrhage Health BEDTIME Professional Prolixin (Fluphenazine Hydrochloride) SS 5 MG/2 DAY Symmetrel (Amantadine Hydrochloride) C Niferex (Polysaccharide-Iron Complex) C Depakote (Valproate Semisodium) C Vitamin B12 C 24-Jun-2005 12:19 PM Page: 1208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3623988-5Report Type:Periodic Company Report #US_000337279 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Zyprexa PS Eli Lilly And Co 2 DSG FORM AT Initial or Prolonged Congestive Health BEDTIME Professional Hydrochlorothiazide C Isordil (Isosorbide Dinitrate) C Vasotec (Enalapril Maleate) C Coumadin (Warfarin Sodium) C Humulin N (Insulin Human Injection, Isophane) C Humulin R (Insulin Human) C Lanoxin (Digoxin) C Lasix (Furosemide) C Date:11/29/00ISR Number: 3623989-7Report Type:Periodic Company Report #US_000337319 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Study Zyprexa PS Eli Lilly And Co 5 MG / 1 AT Hospitalization - Suicide Attempt Health BEDTIME Initial or Prolonged Professional Klonopin (Clonazepam) C Neurontin (Gabapentin) C Lithium C Date:11/29/00ISR Number: 3623990-3Report Type:Periodic Company Report #US_000337526 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Zyprexa PS Eli Lilly And Co 25 MG/DAY 1 YR Musculoskeletal Stiffness Professional Overdose Company Schizophreniform Disorder Representative Date:11/29/00ISR Number: 3624076-4Report Type:Periodic Company Report #US_990623991 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Consumer Zyprexa PS Eli Lilly And Co Prozac (Fluoxetine Hydrochloride) SS 40 MG/1 DAY 6 YR Valium C Date:11/29/00ISR Number: 3624078-8Report Type:Periodic Company Report #US_000438794 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Hallucination Health Placebo SS 2 MG/ 1 DAY Professional 24-Jun-2005 12:19 PM Page: 1209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624080-6Report Type:Periodic Company Report #US_990623992 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Literature Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 14 DAY Initial or Prolonged Leukopenia Health Risperidone C Professional Company Representative Date:11/29/00ISR Number: 3624081-8Report Type:Periodic Company Report #US_990623999 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Hostility Health Prozac C Professional Ferrous Sulfate C Date:11/29/00ISR Number: 3624082-XReport Type:Periodic Company Report #US_990624088 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Hydrochlorothiazide C Vitamin E C Ginkgo Biloba C Centrum Silver C The Brain Iii Energizer C The Brain Iii Am C Vitamin B12 C Lecithin C Miacalcin C Oscal C Azithromycin C Digoxin C Aspirin Protect C Diltiazem C Date:11/29/00ISR Number: 3624083-1Report Type:Periodic Company Report #US_000438830 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Study Zyprexa PS Eli Lilly And Co 2 DSG FORM AT Initial or Prolonged Health BEDTIME Professional Nitrodur C Prevacid C Hydrochlorothiazide C Hydralazine C Aspirin C Atrovent C Peri-Colace C Lactulose C Vioxx C 24-Jun-2005 12:19 PM Page: 1210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624084-3Report Type:Periodic Company Report #US_990624286 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 15 MG Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624085-5Report Type:Periodic Company Report #US_000438865 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/ 1 Initial or Prolonged Schizophreniform Disorder Health AT BEDTIME Professional Date:11/29/00ISR Number: 3624086-7Report Type:Periodic Company Report #US_000438866 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Health Simvastatin C Professional Mu Ltivitamins C Vitamin E C Date:11/29/00ISR Number: 3624088-0Report Type:Periodic Company Report #US_990624338 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS Eli Lilly And Co 15 MG/1 AT Initial or Prolonged Health BEDTIME Professional Depakote C Estrostep C Prozac C Cogentin C Date:11/29/00ISR Number: 3624089-2Report Type:Periodic Company Report #US_000438893 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS Eli Lilly And Co 1000 MG/ DAY Initial or Prolonged Stupor Professional Depakote C Tachycardia Company Urinary Retention Representative Date:11/29/00ISR Number: 3624091-0Report Type:Periodic Company Report #US_000438933 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Study Zyprexa PS Eli Lilly And Co 4 DSG FORM/ 1 Initial or Prolonged Health AT BEDTIME Professional Klonopin C Tiazac C Atenolol C Detrol C Lanoxin C Zoloft C 24-Jun-2005 12:19 PM Page: 1211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Demadex C Remeron C Vicon C Date:11/29/00ISR Number: 3624094-6Report Type:Periodic Company Report #US_000439008 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Zyprexa PS Eli Lilly And Co 15 MG/ 1 DAY Professional Company Representative Date:11/29/00ISR Number: 3624095-8Report Type:Periodic Company Report #US_990624421 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Psychotic Disorder Health BEDTIME Professional Restoril C Nifedipine C Donepezil C Metamucil C Hemorrhoidal Ointment C Trazodone C Date:11/29/00ISR Number: 3624097-1Report Type:Periodic Company Report #US_000439094 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 12MG Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG Ativan C Lo/Ovral C Multivitamin C Calcium C Tylenol C Ferrous Sulfate C Nasonex C Date:11/29/00ISR Number: 3624100-9Report Type:Periodic Company Report #US_000439130 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Initial or Prolonged Health Placebo SS 2 DSG FORM/ 2 Professional DAY 24-Jun-2005 12:19 PM Page: 1212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624102-2Report Type:Periodic Company Report #US_000439222 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Buccoglossal Syndrome Consumer Zyprexa PS Eli Lilly And Co 30 MG/ 1 DAY Initial or Prolonged Movement Disorder Wellbutrin C Overdose Haloperidol C Suicide Attempt Effexor C Date:11/29/00ISR Number: 3624105-8Report Type:Periodic Company Report #US_000439277 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Zyprexa PS Eli Lilly And Co 5 MG/ DAY Hospitalization - Professional Clozaril (Clozapine) C Initial or Prolonged Other Trinalin C Nitrostat (Glyceryl Trinitrate) C Alupent (Orciprenaline Sulfate) C Tagamet (Cimetidine) C Date:11/29/00ISR Number: 3624106-XReport Type:Periodic Company Report #US_990724531 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Aricept C Glyburide C Date:11/29/00ISR Number: 3624107-1Report Type:Periodic Company Report #US_000439298 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Laboratory Test Abnormal Professional Celexa (Citalopram Schizophreniform Disorder Hydrobromide) C Tegretol (Carbamazepine) C Date:11/29/00ISR Number: 3624108-3Report Type:Periodic Company Report #US_000439329 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM / Initial or Prolonged Health 1 AT BEDTIME Professional Date:11/29/00ISR Number: 3624109-5Report Type:Periodic Company Report #US_000439343 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa PS Eli Lilly And Co 2 DSG FORM / Initial or Prolonged Urinary Tract Infection Health 1 AT BEDTIME Professional Coumadin (Warfarin 24-Jun-2005 12:19 PM Page: 1213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Lanoxin (Digoxin) C Aricept (Donepezil Hydrochloride) C Vitamin E C Multivitamin C Xanax (Alprazolam) C Date:11/29/00ISR Number: 3624110-1Report Type:Periodic Company Report #US_990724781 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 15 MG DAY Initial or Prolonged Schizophreniform Disorder Health Effexor C Professional Depo Provera C Atrovent C Seroquel C Prilosec C Date:11/29/00ISR Number: 3624111-3Report Type:Periodic Company Report #US_000439362 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 15 G/DAY Initial or Prolonged Professional Effexor (Venlafaxine Hydrochloride) C Risperdal (Risperidone) C Date:11/29/00ISR Number: 3624112-5Report Type:Periodic Company Report #US_000439475 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Study Zyprexa PS Eli Lilly And Co 1 DSG FORM / Initial or Prolonged Health 1 DAY Professional Prinzide C Norpace (Disopyramide Phosphate) C Corgard (Nadolol) C Naproxen C Date:11/29/00ISR Number: 3624113-7Report Type:Periodic Company Report #US_990724914 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Initial or Prolonged Leukocytosis Professional BEDTIME Pyrexia Aspirin C Red Blood Cell Iron C Sedimentation Rate Metolazone C Increased Prevacid C Lasix C K-Dur C Digoxin C 24-Jun-2005 12:19 PM Page: 1214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624114-9Report Type:Periodic Company Report #US_000439609 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health No Study Drug SS Professional Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Seroquel C Date:11/29/00ISR Number: 3624115-0Report Type:Periodic Company Report #US_000439632 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Gastrointestinal Health BEDTIME Haemorrhage Professional No Study Drug SS Hypoxia Zoloft (Sertraline Nervousness Hydrochloride) C Multivitamin C Bisacodyl C Cimetidine C Colace (Docusate Sodium) C Trazodone C Ativan (Lorazepam) C Zocor (Simvastatin) C Date:11/29/00ISR Number: 3624116-2Report Type:Periodic Company Report #US_000439689 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624117-4Report Type:Periodic Company Report #US_000439706 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM / Initial or Prolonged Suicide Attempt Health 1 DAY Professional Date:11/29/00ISR Number: 3624118-6Report Type:Periodic Company Report #US_000440393 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Study Zyprexa PS Eli Lilly And Co 10 MG AT Initial or Prolonged Health BEDTIME Professional Aspirin C Beclomethasone C Metoprolol C Trazodone C Albuterol C Ibuprofen C 24-Jun-2005 12:19 PM Page: 1215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624119-8Report Type:Periodic Company Report #US_000440412 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Zyprexa PS Eli Lilly And Co 2.5 MG Initial or Prolonged Health Valium (Diazepam) C Professional Aricept (Donepezil Hydrochloride) C Naprosyn (Naproxen) C K-Dur (Potassium Chloride) C Vitamin B12 C Date:11/29/00ISR Number: 3624120-4Report Type:Periodic Company Report #US_000439738 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Health Ovcon C Professional Ativan(Lorazepam) C Date:11/29/00ISR Number: 3624121-6Report Type:Periodic Company Report #US_000440432 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 5 MG/1 EVERY Initial or Prolonged Health OTHER DAY Professional Nizatidine C Atenolol C Paroxetine C Ambien (Zolpidem Tartrate) C Ativan (Lorazepam) C Date:11/29/00ISR Number: 3624122-8Report Type:Periodic Company Report #US_000439798 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Albuterol C Theo-Dur (Theophylline) C Oxygen C Vitamin E C Calcium C Multivitamin C Darvocet-N C Date:11/29/00ISR Number: 3624123-XReport Type:Periodic Company Report #US_000540654 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa PS Eli Lilly And Co 7.5 MG / 1 Phosphokinase Increased Professional DAY Laboratory Test Abnormal Company Thorazine Representative (Chlorpromazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benzatropine Mesilate) C Date:11/29/00ISR Number: 3624124-1Report Type:Periodic Company Report #US_000439907 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health Zyprexa (Olanzapine) C Professional Zoloft (Sertraline Hydrochloride) C Date:11/29/00ISR Number: 3624125-3Report Type:Periodic Company Report #US_000540868 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Professional Company Representative Date:11/29/00ISR Number: 3624126-5Report Type:Periodic Company Report #US_000540875 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Ativan (Lorazepam) C Professional Cogentin (Benzatropine Mesilate) C Restoril (Temazepam) C Tegretol (Carbamazepine) C Date:11/29/00ISR Number: 3624127-7Report Type:Periodic Company Report #US_000439942 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Zyprexa PS Eli Lilly And Co 5 MG MG/1 AT Initial or Prolonged Health BEDTIME Professional Lithium C Thorazine (Chlorpromazine Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Ditropan (Oxybutynin) C 24-Jun-2005 12:19 PM Page: 1217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624128-9Report Type:Periodic Company Report #US_000540903 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paraesthesia Study Zyprexa PS Eli Lilly And Co 6 MG/1 DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG/1 DAY Premphase C Zestoretic C Allegra (Fexofenadine Hydrochloride) C Allergy Shot C Tagamet (Cimetidine) C Ibuprofen C Prilosec (Omeprazole) C Hydrochlorothiazide C Fiber C Date:11/29/00ISR Number: 3624129-0Report Type:Periodic Company Report #US_000440071 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Consumer Zyprexa PS Eli Lilly And Co 2 DAY Initial or Prolonged Health Neutrontin Professional (Gabapentin) C Celebrex (Celecoxib) C Effexor (Venlafaxine Hydrochloride) C Ultram (Tramadol Hydrochloride) C Klonopin (Clonazepam) C Zocor (Simvastatin) C Norvasc (Amlodipine Besilate) C Synthroid (Levothyroxine Sodium) C Coumadin (Warfarin Sodium) C Date:11/29/00ISR Number: 3624130-7Report Type:Periodic Company Report #US_000540921 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Zyprexa PS Eli Lilly And Co 20 MG/1 AT Initial or Prolonged Gastroenteritis Health BEDTIME Vomiting Professional Serzone (Nefazodone Hydrochloride) C Date:11/29/00ISR Number: 3624131-9Report Type:Periodic Company Report #US_000440142 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Suicide Attempt Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 1218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5 MG/1 DAY AT BEDTIME Ambien (Zolpidem Tartrate) C Trazodone C Celexa (Citalopram Hydrobromide) C Date:11/29/00ISR Number: 3624132-0Report Type:Periodic Company Report #US_000540963 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Ketoacidosis Professional Company Representative Date:11/29/00ISR Number: 3624133-2Report Type:Periodic Company Report #US_000540965 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketoacidosis Health Zyprexa PS Eli Lilly And Co 20 MG/DAY 6 MON Professional Company Representative Date:11/29/00ISR Number: 3624134-4Report Type:Periodic Company Report #US_000440152 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Zyprexa PS Eli Lilly And Co 25 MG/1 AT Ketoacidosis Health BEDTIME 5 MON Weight Increased Professional Date:11/29/00ISR Number: 3624135-6Report Type:Periodic Company Report #US_000440161 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/1 Initial or Prolonged Health DAY Professional Premarin (Estrogens Conjugated) C Paroxsysmal Atrial Fibrillation C Vasotec (Enalapril Maleate) C Synthroid (Levothyroxine Sodium) C Lanoxin (Digoxin) C Coumadin (Warfarin Sodium) C Pepcid Ac(Famotidine) C 24-Jun-2005 12:19 PM Page: 1219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium C Tylenol Extra Strength (Paracetamol) C Colon Cleanser C Date:11/29/00ISR Number: 3624136-8Report Type:Periodic Company Report #US_000440162 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Zyprexa PS Eli Lilly And Co 20 MG/ 1 DAY Ketoacidosis Health Professional Date:11/29/00ISR Number: 3624137-XReport Type:Periodic Company Report #US_000440285 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subdural Haematoma Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624140-XReport Type:Periodic Company Report #US_000541034 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vomiting Study Zyprexa PS Eli Lilly And Co 10 MG/ AT Initial or Prolonged Health BEDTIME Professional Zoloft C Proventil Inhaler C Date:11/29/00ISR Number: 3624143-5Report Type:Periodic Company Report #US_000541044 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Lactic Acidosis Professional Prozac (Fluoxetine Nausea Hydrochloride) SS Vomiting Date:11/29/00ISR Number: 3624146-0Report Type:Periodic Company Report #US_000541050 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 25 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine Hydrochloride SS 60 MG/ 1 IN THE MORNING Prevacid C Loestrin C Naprosyn C Tylenol C 24-Jun-2005 12:19 PM Page: 1220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624148-4Report Type:Periodic Company Report #US_000541109 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Study Zyprexa PS Eli Lilly And Co 2.5 MG Initial or Prolonged Health Risperidone SS Professional Paxil C Ativan C Date:11/29/00ISR Number: 3624151-4Report Type:Periodic Company Report #US_000541159 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional Placebo SS Haldol C Date:11/29/00ISR Number: 3624154-XReport Type:Periodic Company Report #US_000541212 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 3 MON Initial or Prolonged Phosphokinase Abnormal Professional Depakote C Other Grand Mal Convulsion Stupor Date:11/29/00ISR Number: 3624156-3Report Type:Periodic Company Report #US_000541223 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Zyprexa PS Eli Lilly And Co 20 MG/1 AT Initial or Prolonged Health BEDTIME Professional ... C Aspirin C Multivitamins And Mineral Suplement C Date:11/29/00ISR Number: 3624157-5Report Type:Periodic Company Report #US_000541272 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624159-9Report Type:Periodic Company Report #US_000541279 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624160-5Report Type:Periodic Company Report #US_981214423 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 4 DSG FORM / Initial or Prolonged Health AT BEDTIME AT Professional BEDTIME Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Clozapine C Docusate C Date:11/29/00ISR Number: 3624161-7Report Type:Periodic Company Report #US_000541293 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624170-8Report Type:Periodic Company Report #US_981214425 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 15 MG/ DAILY Initial or Prolonged Health DAY Professional Cogentin C Effexor C Date:11/29/00ISR Number: 3624172-1Report Type:Periodic Company Report #US_000541300 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624175-7Report Type:Periodic Company Report #US_000541303 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624177-0Report Type:Periodic Company Report #US_000541306 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624180-0Report Type:Periodic Company Report #US_000541359 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Professional Ativan C Company Synthroid C Representative Desipramine C Date:11/29/00ISR Number: 3624182-4Report Type:Periodic Company Report #US_000541427 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Weight Increased Professional Depakote C Company Representative Date:11/29/00ISR Number: 3624185-XReport Type:Periodic Company Report #US_981214696 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 4 DSG FORM/ 1 Initial or Prolonged Health DAY Professional Valproic Acid C Ecotrin C Date:11/29/00ISR Number: 3624186-1Report Type:Periodic Company Report #US_000541461 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Attention Professional Benztropine C Deficit/Hyperactivity Famotidine C Disorder Claritin C Blood Urea Increased Timolol C Dehydration Atropine C Salivary Hypersecretion Sedation Date:11/29/00ISR Number: 3624188-5Report Type:Periodic Company Report #US_000541599 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3624191-5Report Type:Periodic Company Report #US_000541791 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Phosphokinase Increased Professional 24-Jun-2005 12:19 PM Page: 1223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624193-9Report Type:Periodic Company Report #US_981215194 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS Eli Lilly And Co 20 MG/ 1 DAY Initial or Prolonged Alcohol Intolerance Health Placebo SS 2 MG Drug Dependence Professional Atenolol C Hostility Diphenhydramine C Gentamicin C Multivitamin C Timolol C Olanzapine C Date:11/29/00ISR Number: 3624194-0Report Type:Periodic Company Report #US_981215248 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Study Zyprexa PS Eli Lilly And Co 7.5 MG / 1 Life-Threatening Health DAY Professional Date:11/29/00ISR Number: 3624210-6Report Type:Periodic Company Report #US_000541923 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS Eli Lilly And Co 5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Coumadin (Warfarin Sodium) C Tenormin (Atenolol) C Glucosamine Chondroitin C Antioxidant C Fish Oil C Vitamin C C Multivitamin C Metamucil (Psyllium Hydrophilic Mucilloid) C Vitamin E C Ativan (Lorazepam) C Date:11/29/00ISR Number: 3624212-XReport Type:Periodic Company Report #US_000541951 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Zyprexa PS Eli Lilly And Co 30 MG/1 AT Leukopenia Professional BEDTIME Overdose Topamax (Topiramate) C Thrombocytopenia Coumadin (Warfarin Sodium) C Cogentin (Benzatropine Mesilate) C Loxitane (Loxapine Succinate) C Vitamin D C Ativan (Lorazepam) C Restoril (Temazepam) C 24-Jun-2005 12:19 PM Page: 1224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamin C Levofloxacin C Date:11/29/00ISR Number: 3624215-5Report Type:Periodic Company Report #US_000541953 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Supraventricular Study Zyprexa PS Eli Lilly And Co 15 MG Initial or Prolonged Tachycardia Health Nizatidine SS 150 MG/2 DAY Professional Albuterol C Lorazepam C Claritin (Loratadine) C Loestrin Fe C Date:11/29/00ISR Number: 3624217-9Report Type:Periodic Company Report #US_000542007 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Ketoacidosis Professional Date:11/29/00ISR Number: 3624219-2Report Type:Periodic Company Report #US_000542022 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Consumer Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Luvox (Fluvoxamine Maleate) C Celexa (Citalopram Hydrobromide) C Date:11/29/00ISR Number: 3624222-2Report Type:Periodic Company Report #US_000542030 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 3 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Tylenol (Paracetamol) C Hydrochlorothiazide C Accupril (Quinapril Hydrochloride) C Synthroid (Levothyroxine Sodium) C Date:11/29/00ISR Number: 3624224-6Report Type:Periodic Company Report #US_000542173 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/1 Initial or Prolonged Neurosis Health IN THE Professional MORNING Fluoxetine Hydrochloride SS 2 DSG FORM/1 24-Jun-2005 12:19 PM Page: 1225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report IN THE EVENING Premarin (Estrogens Conjugated) C Pepcid (Famotidine) C Centrum C Tums C Date:11/29/00ISR Number: 3624226-XReport Type:Periodic Company Report #US_000542185 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa PS Eli Lilly And Co 100 MG/1 DAY 6 MON Initial or Prolonged Intentional Misuse Professional Adderall C Sedation Company Effexor (Venlafaxine Stupor Representative Hydrochloride) C Neurontin (Gabapentin) C Date:11/29/00ISR Number: 3624228-3Report Type:Periodic Company Report #US_000542536 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amblyopia Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Intentional Misuse Professional Date:11/29/00ISR Number: 3624230-1Report Type:Periodic Company Report #US_000542549 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 5 MG Initial or Prolonged Mania Health Aspirin C Professional Multivitamin C Date:11/29/00ISR Number: 3624255-6Report Type:Periodic Company Report #US_000134398 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS Eli Lilly And Co 5 MG /1 AT Initial or Prolonged Hyperglycaemia Professional BEDTIME Serzone (Nefazodone Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/29/00ISR Number: 3624258-1Report Type:Periodic Company Report #US_000134444 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Weight Increased Professional Effexor (Venlafaxine Company Hydrochloride) C Representative 24-Jun-2005 12:19 PM Page: 1226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624275-1Report Type:Periodic Company Report #US_000134550 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 17.5 MG / Initial or Prolonged Health 1DAY Professional Zoloft (Sertraline Hydrochloride) C Date:11/29/00ISR Number: 3624278-7Report Type:Periodic Company Report #US_000134554 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS Eli Lilly And Co 2 DSG FORM / Initial or Prolonged Psychotic Disorder Health 1 DAY Professional Date:11/29/00ISR Number: 3624279-9Report Type:Periodic Company Report #US_990115579 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 5 MG/ QHS AT Initial or Prolonged Haematemesis Health BEDTIME Personality Disorder Professional Acetaminophen C Ranitidine C Trazodone C Multivitamins C Folic Acid C Date:11/29/00ISR Number: 3624281-7Report Type:Periodic Company Report #US_000134664 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Buccoglossal Syndrome Health Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY Initial or Prolonged Deafness Professional Lithium C Drug Withdrawal Syndrome Clonidine C Dyskinesia Zoloft (Sertraline Hormone Level Abnormal Hydrochloride) C Oculogyration Adderall C Date:11/29/00ISR Number: 3624283-0Report Type:Periodic Company Report #US_000134711 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Study Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Health Nizatidine Professional (Nizatidine) SS Date:11/29/00ISR Number: 3624284-2Report Type:Periodic Company Report #US_000134758 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Health Glucotrol Professional (Glipizide) C Prinivil (Lisinopril) C 24-Jun-2005 12:19 PM Page: 1227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin (Estrogens Conjugated) C Norvasc (Amlodipine Besilate) C Aspirin C Date:11/29/00ISR Number: 3624286-6Report Type:Periodic Company Report #US_000134826 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Study Zyprexa PS Eli Lilly And Co 2 DSG FORM / Initial or Prolonged Health 1 DAY Professional Norvasc (Amlodipine Besilate) C Lipitor (Atorvastatin) C Premarin (Estrogens Conjugated) C Celebrex (Celcoxib) C Date:11/29/00ISR Number: 3624288-XReport Type:Periodic Company Report #US_000134838 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thinking Abnormal Study Zyprexa PS Eli Lilly And Co 2 DSG FORM / Initial or Prolonged Urinary Tract Infection Health 1 AT BEDTIME Professional Ativan (Lorazepam) C Precose (Acarbose) C Zoloft (Sertraline Hydrochloride) C Colace (Docusate Sodium) C Vicon-C C Clonidine C Aspirin (E.C.) (Acetylsalicylic Acid) C Date:11/29/00ISR Number: 3624290-8Report Type:Periodic Company Report #US_000235175 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Study Zyprexa PS Eli Lilly And Co 10 MG / 1 AT Health BEDTIME Professional Valium (Diazepam) C Date:11/29/00ISR Number: 3624292-1Report Type:Periodic Company Report #US_980504135 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Depakote C Sudafed C Bc Powder C Genora C 24-Jun-2005 12:19 PM Page: 1228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vicks Formula 44 C Testosterone Propionate C Prozac C Multivitamin C Date:11/29/00ISR Number: 3624293-3Report Type:Periodic Company Report #US_980504206 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accident Study Zyprexa PS Eli Lilly And Co 10 MG/1 AT Hospitalization - Intestinal Obstruction Health BEDTIME Initial or Prolonged Professional Oxycodone C Acetaminophen C Erythromycin C Valciclovir C Hydrochloriathiazide /Triamterene C Fluoxetine C Lorazepam C Multivitamin C Ascorbic Acid C Lisinopril C Terazosin C Date:11/29/00ISR Number: 3624294-5Report Type:Periodic Company Report #US_980604490 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS Eli Lilly And Co 10 MG/AT Initial or Prolonged Health BEDTIME Professional Divalproex Sodium C Ativan C Date:11/29/00ISR Number: 3624295-7Report Type:Periodic Company Report #US_980604759 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS Eli Lilly And Co 5 MG/D DAY Initial or Prolonged Depression Health Depakote C Professional Loestrin C Date:11/29/00ISR Number: 3624297-0Report Type:Periodic Company Report #US_980604776 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Study Zyprexa PS Eli Lilly And Co 20 MG AT Initial or Prolonged Depression Health BEDTIME Hallucination Professional Depakote C Hostility Injury Paranoia Sedation 24-Jun-2005 12:19 PM Page: 1229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624298-2Report Type:Periodic Company Report #US_980604858 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa PS Eli Lilly And Co 10 MG/ AT Initial or Prolonged Apathy Other BEDTIME Epistaxis Phenylpropanolamine Hallucination W/Guaifenesin C Hostility Tessalon Perle C Influenza Like Illness Septra Ds C Muscle Twitching Personality Disorder Psychotic Disorder Tinnitus Weight Decreased Weight Increased Date:11/29/00ISR Number: 3624299-4Report Type:Periodic Company Report #US_980808397 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 5 MG/QHS AT Initial or Prolonged Cardiac Failure Health BEDTIME Congestive Professional Captopril C Dyspnoea Docusate C Nausea Ferrous Gluconate C Oedema Gemfibrozil C Hexavitamin C Isosorbide Dinitrate C Lansoprazole C Lovastatin C Metolazone C Potassium Chloride C Terazosin C Vitamin E C Acetaminophen C Clonazepam C Aluminium Magnesium Silicate C Magnesium Hydroxide C Promethazine C Albuterol C Ipratropium C Furosemide C Cyanocobalamin C Insulin C Warfarin C Date:11/29/00ISR Number: 3624300-8Report Type:Periodic Company Report #US_980910846 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Placebo SS Professional Zantac C Hydrochlorothiazide C Atrovent C Serevent C Aerobid-M C Theodur Retard C 24-Jun-2005 12:19 PM Page: 1230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Ocean Nasal Spray C Date:11/29/00ISR Number: 3624302-1Report Type:Periodic Company Report #US_981113074 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS Eli Lilly And Co 10 MG/D DAY Initial or Prolonged Insomnia Health Placebo SS Professional Hydroxyzine C Trazodone C Ativan C Hydrochlorothiazide C Olanzapine C Divalproex Sodium C Multivitamins C Lorazepam C Verapamil C Vitamin E C Date:11/29/00ISR Number: 3624303-3Report Type:Periodic Company Report #US_981113076 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 15 MG/D DAY Initial or Prolonged Hallucination Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 20 MG DAY Zestril C Prolixin C Cogentin C Date:11/29/00ISR Number: 3624305-7Report Type:Periodic Company Report #US98013982A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Zyprexa PS Eli Lilly And Co 15 MG / 1 DAY Initial or Prolonged Health Depakote (Valproate Other Professional Semisodium) C Ativan (Lorazepam) C Tylenol (Paracetamol) C Date:11/29/00ISR Number: 3624306-9Report Type:Periodic Company Report #US98030667A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Zyprexa PS Eli Lilly And Co 5 MG Initial or Prolonged Paranoia Health Psychotic Disorder Professional 24-Jun-2005 12:19 PM Page: 1231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624308-2Report Type:Periodic Company Report #US_000133471 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Face Oedema Professional Omeprazole C Hyperglycaemia Beconase Sedation (Beclometasone Weight Increased Dipropionate) C Date:11/29/00ISR Number: 3624309-4Report Type:Periodic Company Report #US_000133513 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624310-0Report Type:Periodic Company Report #US_000133546 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Study Zyprexa PS Eli Lilly And Co 15 MG Initial or Prolonged Depression Health Professional Date:11/29/00ISR Number: 3624313-6Report Type:Periodic Company Report #US_000133592 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Study Zyprexa PS Eli Lilly And Co 2.5 AT Pneumonia Health BEDTIME Professional Ativan (Lorazepam) C Celexa (Citalopram Hydrobromide) C Trazodone C Children'S Aspirin (Acetylsalicylic Acid) C Triamterene / Hydrochlorothiazide C Inapsine (Droperidol) C Multivitamin And Mineral Supplement C Keflex (Cefalexin Monohydrate) C Date:11/29/00ISR Number: 3624315-XReport Type:Periodic Company Report #US_000133600 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Health Amoxicillin C Professional Ativan (Lorazepam) C Hydrocortisone C Chloral Hydrate C Klonopin 24-Jun-2005 12:19 PM Page: 1232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Date:11/29/00ISR Number: 3624316-1Report Type:Periodic Company Report #US_000133673 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Zyprexa PS Eli Lilly And Co 7 MG/QAM DAY Hospitalization - Health Prevacid Initial or Prolonged Professional (Lansoprazole) C Metamucil (Psyllium Hydrophilic Mucilloid) C Regulcid C Multivitamin C Trazodone C Trusopt (Dorzolamide Lactate) C Lac-Hydrin (Ammonium Lactate) C Two-Cal Hn C Aricept (Donepezil Hydrochloride) C Buspar (Buspirone Hydrochloride) C Furosemide C K-Dur (Potassium Chloride) C Lanoxin (Digoxin) C Acetaminophen C Lortab Elixir C Ativan (Lorazepam) C Levaquin (Levofloxacin) C Guaifenesin C Date:11/29/00ISR Number: 3624317-3Report Type:Periodic Company Report #US_000133692 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Initial or Prolonged Health DAY Professional Placebo SS 1 DSG FORM/2 DAY Acetaminophen C Benztropine C Nortriptyline C Verapamil C Date:11/29/00ISR Number: 3624318-5Report Type:Periodic Company Report #US_000133701 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Zyprexa PS Eli Lilly And Co 10 MG/ 1 AT Initial or Prolonged Suicide Attempt Health BEDTIME Professional 24-Jun-2005 12:19 PM Page: 1233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624319-7Report Type:Periodic Company Report #US_000133711 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS Eli Lilly And Co 15 MG/1 AT Initial or Prolonged Depression Health BEDTIME Paranoia Professional Atenolol C Lorazepam C Loperamide C Date:11/29/00ISR Number: 3624320-3Report Type:Periodic Company Report #US_990115610 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Zyprexa PS Eli Lilly And Co 15 MG/ 1/ D Initial or Prolonged Delusion Health DAY Diarrhoea Professional Prozac (Fluoxetine Hyperglycaemia Hydrochloride) SS 20 MG/ 1 /D Nausea DAY Psychotic Disorder Adalat C Vomiting Lasix C Lanoxin C Ativan C Cogentin C Vitamin E C Vitamin C C Date:11/29/00ISR Number: 3624321-5Report Type:Periodic Company Report #US_000133934 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Confusional State Leukocytosis Pyrexia Tremor Date:11/29/00ISR Number: 3624323-9Report Type:Periodic Company Report #US_000133946 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Study Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Hospitalization - Health Initial or Prolonged Professional Date:11/29/00ISR Number: 3624325-2Report Type:Periodic Company Report #US_000133957 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 1 DSG FORM/1 Initial or Prolonged Health DAY Professional Lorazepam C 24-Jun-2005 12:19 PM Page: 1234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3624326-4Report Type:Periodic Company Report #US_990116207 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 2.5 MG / 1 Initial or Prolonged Health DAY Professional Date:11/29/00ISR Number: 3624328-8Report Type:Periodic Company Report #US_000134029 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Health Professional Date:11/29/00ISR Number: 3624330-6Report Type:Periodic Company Report #US_990116504 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/ 1 Health IN THE Professional EVENING Depakote C Zocor C Accupril C Atenolol C Ambien C Date:11/29/00ISR Number: 3624333-1Report Type:Periodic Company Report #US_990217585 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS Eli Lilly And Co 10 MG / 1 AT Initial or Prolonged Depression Health BEDTIME Euphoric Mood Professional Naproxen C Insomnia Pepto-Bismol C Mania Alka-Seltzer C Thinking Abnormal Echinacea Extract C Goldenseal C Depakote C Ativan C Hydrochlorothiazide/ Triamterene C Date:11/29/00ISR Number: 3624354-9Report Type:Periodic Company Report #US_000134160 Age:18 MON Gender:Male I/FU:I Outcome PT Hospitalization - Accidental Overdose Initial or Prolonged Agitation Blood Alkaline Phosphatase Increased Dyspnoea Gastric Atony Hyperglycaemia Mucous Membrane Disorder Respiratory Alkalosis 24-Jun-2005 12:19 PM Page: 1235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Tachycardia Report Source Product Role Manufacturer Route Dose Duration Literature Zyprexa PS Eli Lilly And Co 40 MG 1 DAY Health Professional Date:11/29/00ISR Number: 3624356-2Report Type:Periodic Company Report #US_000134224 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Study Zyprexa PS Eli Lilly And Co 7.5 MG Life-Threatening Health Lasix C Hospitalization - Professional Lotensin C Initial or Prolonged Vitamin E C Klor-Con C Date:11/29/00ISR Number: 3624357-4Report Type:Periodic Company Report #US_000134272 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Study Zyprexa PS Eli Lilly And Co 10 MG Health Placebo SS Professional Depakote C Lithium C Vasotec C Glucotrol C Date:11/29/00ISR Number: 3624358-6Report Type:Periodic Company Report #US_000134383 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Health Propranolol C Professional Benztropine C Date:11/29/00ISR Number: 3624360-4Report Type:Periodic Company Report #US_000134397 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa PS Eli Lilly And Co 15 MG/1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 2 MG/DAY Tylenol W/Codeine No. 3 C Nicotine C Propranolol C Date:11/29/00ISR Number: 3631310-3Report Type:Periodic Company Report #US_000846801 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co 5 MG / 1 DAY Professional Company Representative 24-Jun-2005 12:19 PM Page: 1236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631311-5Report Type:Periodic Company Report #US_000846920 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 35 MG/AT Professional BEDTIME Company Prozac (Fluoxetine Representative Hydrochloride) SS 10 MG/EVERY OTHER DAY Depakote (Valproate Semisodium) C Prenate Ultra C Tylenol (Paracetamol) C Date:11/29/00ISR Number: 3631313-9Report Type:Periodic Company Report #US_000847048 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Zyprexa PS Eli Lilly And Co 25 MG/1 DAY Date:11/29/00ISR Number: 3631315-2Report Type:Periodic Company Report #US_000847103 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Optic Neuritis Health Zyprexa PS Eli Lilly And Co 3 YR Professional Zoloft (Sertraline Hydrochloride) C Verapamil C Date:11/29/00ISR Number: 3631316-4Report Type:Periodic Company Report #US_000847117 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY 1 MON Professional Mellaril Company (Thioridazine Representative Hydrochloride) C Date:11/29/00ISR Number: 3631327-9Report Type:Periodic Company Report #US_000847370 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Hair Colour Changes Professional Zoloft (Sertraline Penis Disorder Hydrochloride) C Date:11/29/00ISR Number: 3631328-0Report Type:Periodic Company Report #US_000847504 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Zyprexa PS Eli Lilly And Co 40 MG/1 DAY Risperdal (Risperidone) C Trileptal (Oxcarbazepine) C Serentil 24-Jun-2005 12:19 PM Page: 1237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mesoridazine) C Date:11/29/00ISR Number: 3631329-2Report Type:Periodic Company Report #US_000847900 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Disorder Other Zyprexa PS Eli Lilly And Co Prozac (Fluoxetine Hydrochloride) SS Risperdal (Risperidone) C Date:11/29/00ISR Number: 3631330-9Report Type:Periodic Company Report #US_000847967 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Health Zyprexa PS Eli Lilly And Co Professional Marijuana C Company Representative Date:11/29/00ISR Number: 3631333-4Report Type:Periodic Company Report #US_000848135 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 15 MG/2 DAY 4 WK Professional Lithium C Ibuprofen C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Topamax (Topiramate) C Date:11/29/00ISR Number: 3631334-6Report Type:Periodic Company Report #US_000644149 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Disorder Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 2 YR Professional Date:11/29/00ISR Number: 3631336-XReport Type:Periodic Company Report #US_000644342 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hormone Level Abnormal Health Zyprexa PS Eli Lilly And Co 1 WK Professional Depakote (Valproate Semisodium) C Remeron (Mirtazapine) C 24-Jun-2005 12:19 PM Page: 1238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631338-3Report Type:Periodic Company Report #US_000644418 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaphylactoid Reaction Health Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY Professional Date:11/29/00ISR Number: 3631340-1Report Type:Periodic Company Report #US_000744628 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lichen Planus Health Zyprexa PS Eli Lilly And Co 5 MG/DAY 2 YR Professional Valium (Diazepam) C Date:11/29/00ISR Number: 3631342-5Report Type:Periodic Company Report #US_000745305 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Insipidus Health Zyprexa PS Eli Lilly And Co 7.5 MG/ 1 DAY Professional Prempro C Oscal/Calcium Carbonate) C Date:11/29/00ISR Number: 3631344-9Report Type:Periodic Company Report #US_000745560 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS Eli Lilly And Co 10 MG/ 1 DAY 3 YR Professional Date:11/29/00ISR Number: 3631346-2Report Type:Periodic Company Report #US_000746009 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS Eli Lilly And Co 20 MG1 DAY Professional Haldol Decanoate Company (Haloperidol Representative Decanoate) C Date:11/29/00ISR Number: 3631347-4Report Type:Periodic Company Report #US_000846367 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3631348-6Report Type:Periodic Company Report #US_000846467 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY 2 MON Urinary Retention Depakote (Valproate Semisodium) C Paxil (Paroxetine 24-Jun-2005 12:19 PM Page: 1239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/29/00ISR Number: 3631349-8Report Type:Periodic Company Report #US_000846523 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Dependence Health Zyprexa PS Eli Lilly And Co 30 MG/ 1 DAY Overdose Professional Company Representative Date:11/29/00ISR Number: 3631350-4Report Type:Periodic Company Report #US_000846545 Age:9 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Consumer Zyprexa PS Eli Lilly And Co Diarrhoea Sleep Disorder Date:11/29/00ISR Number: 3631351-6Report Type:Periodic Company Report #US_000338038 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemolytic Anaemia Health Zyprexa PS Eli Lilly And Co Professional Date:11/29/00ISR Number: 3631352-8Report Type:Periodic Company Report #US_000338042 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3631353-XReport Type:Periodic Company Report #US_000338047 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS Eli Lilly And Co 12 MG/DAY Abnormal Professional Sertraline C Company Risperdal Representative (Risperidone) C Date:11/29/00ISR Number: 3631354-1Report Type:Periodic Company Report #US_000438631 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Respiratory Disorder Health Zyprexa PS Eli Lilly And Co 10 MG/DAY 1 MON Professional Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 1240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631355-3Report Type:Periodic Company Report #US_000438637 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Respiratory Disorder Health Zyprexa PS Eli Lilly And Co 10 MG/DAY 5 MON Professional Date:11/29/00ISR Number: 3631356-5Report Type:Periodic Company Report #US_000438878 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Eli Lilly And Co 15 MG / 1 DAY Professional Company Representative Date:11/29/00ISR Number: 3631358-9Report Type:Periodic Company Report #US_000439057 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa PS Eli Lilly And Co 6 MON Professional Radiation Therapy C Date:11/29/00ISR Number: 3631359-0Report Type:Periodic Company Report #US_000439314 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Prozac C Gabapentin C Date:11/29/00ISR Number: 3631360-7Report Type:Periodic Company Report #US_000439659 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co 20 MG / DAY 3 YR Professional Clozapine C Depakote (Valproate Semisodium) C Folic Acid C Detrol (Tolterodine) C Hydroxyzine C Zantac (Ranitidine Hydrochloride) C Desmopressin C Enalapril C Date:11/29/00ISR Number: 3631361-9Report Type:Periodic Company Report #US_000439817 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Professional Company Representative 24-Jun-2005 12:19 PM Page: 1241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631368-1Report Type:Periodic Company Report #US_000133621 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Professional Cogentin C Haldol C Cannabis C Date:11/29/00ISR Number: 3631370-XReport Type:Periodic Company Report #US_000133899 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Health Zyprexa PS Eli Lilly And Co 60 MG/DAY 1 DAY Professional Effexor C Date:11/29/00ISR Number: 3631372-3Report Type:Periodic Company Report #US_000134142 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Penis Disorder Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY 18 MON Date:11/29/00ISR Number: 3631373-5Report Type:Periodic Company Report #US_000134147 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Corneal Lesion Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Professional Adderall C Company Representative Date:11/29/00ISR Number: 3631374-7Report Type:Periodic Company Report #US_000134151 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neurosis Health Zyprexa PS Eli Lilly And Co 17.5 MG/DAY 14 WK Professional Stelazine (Trigluoperazine Hydrochloride) C Date:11/29/00ISR Number: 3631375-9Report Type:Periodic Company Report #US_000134226 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Professional Depakote C Neurontin C Date:11/29/00ISR Number: 3631377-2Report Type:Periodic Company Report #US_000134385 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa PS Eli Lilly And Co Lithobid C 24-Jun-2005 12:19 PM Page: 1242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631378-4Report Type:Periodic Company Report #US_000134530 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Consumer Zyprexa PS Eli Lilly And Co Date:11/29/00ISR Number: 3631379-6Report Type:Periodic Company Report #US_000134747 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 60 MG/DAY A Professional FEW DAYS Haldol C Date:11/29/00ISR Number: 3631381-4Report Type:Periodic Company Report #US_000134837 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3631383-8Report Type:Periodic Company Report #US_000950755 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 7 MON Professional Lithium C Date:11/29/00ISR Number: 3631385-1Report Type:Periodic Company Report #US_990218102 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Professional Date:11/29/00ISR Number: 3631387-5Report Type:Periodic Company Report #US_990725058 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Professional Depakote (Valproate Semisodium) C Multivitamins W/Minerals C Date:11/29/00ISR Number: 3631394-2Report Type:Periodic Company Report #US_991029359 Age:80 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS Eli Lilly And Co Professional Company Representative 24-Jun-2005 12:19 PM Page: 1243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631396-6Report Type:Periodic Company Report #US_991030109 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Consumer Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Depakote C Zoloft C Ativan C Date:11/29/00ISR Number: 3631399-1Report Type:Periodic Company Report #US_991030485 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 1 MON Nortriptyline C Date:11/29/00ISR Number: 3631400-5Report Type:Periodic Company Report #US_991130601 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co Thrombocytopenia Professional Celexa C Date:11/29/00ISR Number: 3631805-2Report Type:Periodic Company Report #US_991130765 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Professional Date:11/29/00ISR Number: 3631808-8Report Type:Periodic Company Report #US_991130994 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:11/29/00ISR Number: 3631814-3Report Type:Periodic Company Report #US_991131443 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Health Zyprexa PS Eli Lilly And Co 15 MG/DAY 1 YR Professional Mellaril C Paxil C Date:11/29/00ISR Number: 3631816-7Report Type:Periodic Company Report #US_991131534 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neurosis Health Zyprexa PS Eli Lilly And Co 5 MG/DAY 18 MON Professional 24-Jun-2005 12:19 PM Page: 1244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631817-9Report Type:Periodic Company Report #US_991131685 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Professional Benadryl C Company Representative Date:11/29/00ISR Number: 3631828-3Report Type:Periodic Company Report #US_991131962 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Prozac (Fluoxetine Company Hydrochloride) SS 20 MG/DAY Representative Depakote C Date:11/29/00ISR Number: 3631831-3Report Type:Periodic Company Report #US_991131963 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Prozac (Fluoxetine Company Hydrochloride) SS 20 MG/DAY Representative Depakote C Date:11/29/00ISR Number: 3631832-5Report Type:Periodic Company Report #US_991131964 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Prozac (Fluoxetine Company Hydrochloride) SS 20 MG/DAY 3 MON Representative Depakote C Date:11/29/00ISR Number: 3631834-9Report Type:Periodic Company Report #US_991232624 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Acne Health Zyprexa PS Eli Lilly And Co 1 MON Professional Date:11/29/00ISR Number: 3631835-0Report Type:Periodic Company Report #US_991232677 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Inappropriate Health Zyprexa PS Eli Lilly And Co Antidiuretic Hormone Professional Wellbutrin C Secretion Company Representative 24-Jun-2005 12:19 PM Page: 1245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3631838-6Report Type:Periodic Company Report #US_991232873 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Pustular Literature Zyprexa PS Eli Lilly And Co 3 WK Health Propanolol C Professional Date:11/29/00ISR Number: 3631841-6Report Type:Periodic Company Report #US_991232889 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intracranial Pressure Health Zyprexa PS Eli Lilly And Co 5 MG/ 1 AT Increased Professional BEDTIME Paxil C Date:11/29/00ISR Number: 3631843-XReport Type:Periodic Company Report #US_991232920 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Professional Effexor C Company Tegretol C Representative Depakote C Date:11/29/00ISR Number: 3631844-1Report Type:Periodic Company Report #US_991233420 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS Eli Lilly And Co 25 MG/DAY Professional Multivitamin C Company Representative Date:11/30/00ISR Number: 3627785-6Report Type:Periodic Company Report #A0125786A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Wellbutrin Sr PS Glaxo Wellcome Inc ORAL ORAL Productive Cough Professional Olanzapine Company (Formulation Representative Unknown) (Olanzapine) SS 5 MG Theophylline C Inhaler C Oral Contraceptive C Date:12/04/00ISR Number: 3620807-8Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa Zydis 5,10,15,20mg PS 24-Jun-2005 12:19 PM Page: 1246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/00ISR Number: 3620816-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa Tablet 10mg Lilly PS Lilly Zyrtec Tablets 10mg Pfizer SS Pfizer Date:12/04/00ISR Number: 3621653-1Report Type:Expedited (15-DaCompany Report #US_001154200 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Eli Lilly And Co Professional Zoloft (Sertraline Company Hydrochloride) C Representative Trazodone C Date:12/04/00ISR Number: 3621654-3Report Type:Expedited (15-DaCompany Report #US_001153999 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Eli Lilly And Co 235 MG/DAY Intentional Misuse Professional Ativan (Lorazepam) C Ibuprofen C Vitamin E C Paroxetine C Date:12/04/00ISR Number: 3621667-1Report Type:Expedited (15-DaCompany Report #A0104288A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Literature Lamictal PS Glaxo Wellcome Inc ORAL 100 MG / ORAL Initial or Prolonged Drug Interaction Health Valproic Acid Leukopenia Professional (Valproic Acid) SS ORAL 750 MG / AT Neutropenia NIGHT / ORAL Suicidal Ideation Olanzapine (Olanzapine) SS ORAL 5 MG / AT NIGHT / ORAL Bupropion Hydrochloride C Clonazepam C Date:12/04/00ISR Number: 3621849-9Report Type:Expedited (15-DaCompany Report #EWC001108580 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Fall Health Hostility Professional Major Depression Other Suicidal Ideation 24-Jun-2005 12:19 PM Page: 1247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/00ISR Number: 3621854-2Report Type:Expedited (15-DaCompany Report #EWC001108585 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY Hyperglycaemia Health Teralithe (Lithium Hypertriglyceridaemia Professional Carbonate) C Weight Increased Other Stablon (Tianeptine) C Largactil (Chlorpromazine Hydrochloride) C Date:12/04/00ISR Number: 3621857-8Report Type:Expedited (15-DaCompany Report #EWC001108595 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Duodenal Ulcer Health Glucophage Gastritis Professional (Metformin Hepatic Steatosis Other Hydrochloride) C Oesophagitis Pancreatitis Acute Scar Date:12/04/00ISR Number: 3621859-1Report Type:Expedited (15-DaCompany Report #EWC001108668 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Foreign Zyprexa PS Eli Lilly And Co 10 MG Epistaxis Health Kemadrin Swelling Professional (Procyclidine Company Hydrochloride) C Representative Lexotanil (Bromazepam) C Date:12/04/00ISR Number: 3621862-1Report Type:Expedited (15-DaCompany Report #EWC001108686 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Health Artane Professional (Trihexyphenidyl Company Hydrochloride) C Representative Zoloft (Sertraline Other Hydrochloride) C Tenormin (Atenolol) C Eurodin (Estazolam) C Magnesium Oxide C Date:12/04/00ISR Number: 3621896-7Report Type:Expedited (15-DaCompany Report #US_001154073 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Eli Lilly And Co 35 MG/DAY Cardiac Arrest Health Anafranil Completed Suicide Professional (Clomipramine Intentional Misuse Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/00ISR Number: 3621897-9Report Type:Expedited (15-DaCompany Report #US_001153158 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Study Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Other Asthenia Health Centrum Silver C Bundle Branch Block Right Professional Vitamin E C Cardiac Disorder Detrol (Tolterodine Cardiomegaly L-Tartrate) C Chromaturia Compression Fracture Condition Aggravated Electrocardiogram Qt Corrected Interval Prolonged Heart Rate Increased Spinal Fracture Ventricular Extrasystoles Date:12/04/00ISR Number: 3621898-0Report Type:Expedited (15-DaCompany Report #GBS001106956 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Renal Failure Acute Health Professional Company Representative Other Date:12/04/00ISR Number: 3621900-6Report Type:Expedited (15-DaCompany Report #GBS001106977 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa PS Eli Lilly And Co Exposure To Therapeutic Health Seroxat (Paroxetine Drugs Professional Hydrochloride) C Polydactyly Other Temazepam C Date:12/04/00ISR Number: 3621903-1Report Type:Expedited (15-DaCompany Report #EWC001108662 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Leponex (Clozapine) C Professional Orfiril (Valproate Company Sodium) C Representative Xanax (Alprazolam) C Other Date:12/04/00ISR Number: 3621907-9Report Type:Expedited (15-DaCompany Report #CA_001102274 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chromosome Abnormality Foreign Zyprexa PS Eli Lilly And Co 10 MG AT Initial or Prolonged Dysphagia Health BEDTIME Nervous System Disorder Professional Aventyl Speech Disorder Other (Nortriptyline 24-Jun-2005 12:19 PM Page: 1249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS 25 MG AT BEDTIME Date:12/04/00ISR Number: 3621954-7Report Type:Expedited (15-DaCompany Report #US_001152798 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Increased Health Amitriptyline C Fatigue Professional Estradiol C Granulomatous Liver Medroxyprogesterone C Disease Hepatic Steatosis Liver Function Test Abnormal Pyrexia Sarcoidosis Date:12/04/00ISR Number: 3622209-7Report Type:Expedited (15-DaCompany Report #EWC000907912 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 10 MG DAY Erysipelas Health UNKNOWN Haemoglobin Decreased Professional Truxal Leukopenia Other (Chlorprothixen Monocytosis Hydrochloride) C Myeloid Maturation Arrest Renitec (Enalapril Neutropenia Maleate) C Pyrexia Sobril (Oxazepam) C Fenergan (Promethazine) C Bricanyl (Terbutaline Sulfate) C Date:12/04/00ISR Number: 3622210-3Report Type:Expedited (15-DaCompany Report #DE_990200877 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 40 MG DAY Initial or Prolonged Hypersensitivity Literature UNKNOWN Leukocytosis Health Lorazepam C Leukopenia Professional Risperidone C Neutropenia Other Benperidol C Overdose Pyrexia Date:12/04/00ISR Number: 3622211-5Report Type:Expedited (15-DaCompany Report #DE_001103445 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co UNKNOWN UNKNOWN 9 DAY Leukopenia Literature Neutropenia Health Pyrexia Professional Other 24-Jun-2005 12:19 PM Page: 1250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/00ISR Number: 3622212-7Report Type:Expedited (15-DaCompany Report #EWC991104979 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa PS Eli Lilly And Co UNKNOWN 5 MG DAY Initial or Prolonged Cardiogenic Shock Literature UNKNOWN Other Hyperglycaemia Health Aricept (Donepezil Loss Of Consciousness Professional Hydrochloride) C Pallor Company Potassium Ascorbate C Representative Ativan (Lorazepam) C Other Seroxat (Paroxetine Hydrochloride) C Imovane (Zopiclone) C Date:12/04/00ISR Number: 3623160-9Report Type:Expedited (15-DaCompany Report #AU_000701672 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Zyprexa PS Eli Lilly And Co 10 MG/ IN THE Initial or Prolonged Pancreatitis Health MORNING Professional Olanzapine SS 20 MG/AT Other BEDTIME Valproate Sodium C Date:12/04/00ISR Number: 3623161-0Report Type:Expedited (15-DaCompany Report #AU_001102219 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Valproate Sodium C Professional Other Date:12/04/00ISR Number: 3623163-4Report Type:Expedited (15-DaCompany Report #EWC001108519 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Keratoconjunctivitis Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Sicca Health Effexor (Venlafaxine Professional Hydrochloride) C Company Seresta (Oxazepam) C Representative Imovane (Zopiclone) C Other Date:12/05/00ISR Number: 3621764-0Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Zyprexa PS ORAL 20 MG PO HS Depakote C Inderal C 24-Jun-2005 12:19 PM Page: 1251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/00ISR Number: 3621766-4Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Zyprexa PS 10MG 2 TABS Consciousness HS Hyperglycaemia Prolixin Deconate C Benadryl C Cogentin C Date:12/05/00ISR Number: 3621771-8Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Olanzapine PS ORAL PO 20MG HS ; Depressed Level Of PO 10MG AM Consciousness Depakote C Hyperglycaemia Benadryl C Renal Failure Acute Prolixin C Tachycardia Prolixin Deconate C Ativan C Date:12/05/00ISR Number: 3621804-9Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blister Zyprexa 5 Mg Po Hs PS ORAL PO 5MG HS Pain Lithium C Vistaril C Date:12/05/00ISR Number: 3622535-1Report Type:Expedited (15-DaCompany Report #US_001154063 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoeic Attack Literature Zyprexa PS Eli Lilly And Co Hospitalization - Blood Chloride Increased Health Ranitidine C Initial or Prolonged Blood Creatine Professional Benztropine Mesylate C Disability Phosphokinase Increased Cephalexin C Other Cognitive Disorder Coma Disturbance In Attention Encephalopathy Haematocrit Decreased Haemoglobin Decreased Hemiplegia Hyperpyrexia Hypotension Labile Blood Pressure Mental Disorder Metabolic Acidosis Mucous Membrane Disorder Muscle Rigidity Neuroleptic Malignant Syndrome Pneumonia Pyrexia Respiratory Distress Tachycardia Tremor 24-Jun-2005 12:19 PM Page: 1252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/00ISR Number: 3622776-3Report Type:Expedited (15-DaCompany Report #GBS000706281 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Zyprexa PS Eli Lilly And Co Bronchopneumonia Health Fluoxetine Cholelithiasis Professional (Fluoxetine Completed Suicide Other Hydrochloride) SS Drug Level Above Carbamazepine C Therapeutic Ecchymosis Overdose Pulmonary Congestion Therapeutic Agent Toxicity Date:12/07/00ISR Number: 3624243-XReport Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Zyprexa (15mg Po Initial or Prolonged Dizziness Qhs) PS ORAL 15MG PO QHS, Hyperglycaemia 10 MG PO QHS Laboratory Test Abnormal Depakote C Malaise Ativan C Cogentin C Benadryl C Date:12/08/00ISR Number: 3625560-XReport Type:Expedited (15-DaCompany Report #S00-NLD-01285-01 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Celexa PS Forest Laboratories Alanine Aminotransferase Health Inc ORAL 60 MG QD PO Increased Professional Cipramil SS ORAL 40 MG QD PO Gamma-Glutamyltransferase Other Cipramil SS ORAL 20 MG QD PO Increased Olanzapine SS ORAL 5 MG QD PO Hepatic Failure Hepatitis A Scleral Disorder Date:12/11/00ISR Number: 3626378-4Report Type:Direct Company Report #USP 53476 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly Norvasc (Amlodipine) SS Pfizer Date:12/11/00ISR Number: 3626471-6Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa (5mg) PS ORAL 5MG PO Q HS Initial or Prolonged Phosphokinase Increased Zoloft C Condition Aggravated Serax C Psychotic Disorder Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 1253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3626691-0Report Type:Expedited (15-DaCompany Report #US_001254771 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co 20 MG/DAY 2 YR Prolonged Professional Myocardial Infarction Company Representative Date:12/11/00ISR Number: 3626693-4Report Type:Expedited (15-DaCompany Report #US_001254698 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa PS Eli Lilly And Co 240 MG/DAY Initial or Prolonged Renal Failure Professional Paxil C Rhabdomyolysis Date:12/11/00ISR Number: 3626694-6Report Type:Expedited (15-DaCompany Report #US_001154478 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Health Zyprexa PS Eli Lilly And Co 15 MG/AT Professional BEDTIME Date:12/11/00ISR Number: 3626800-3Report Type:Expedited (15-DaCompany Report #US_001254576 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercholesterolaemia Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Hyperglycaemia Professional Panic Attack Company Representative Date:12/11/00ISR Number: 3626829-5Report Type:Expedited (15-DaCompany Report #US_001051493 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Professional Other Company Representative Date:12/11/00ISR Number: 3626830-1Report Type:Expedited (15-DaCompany Report #US_001154200 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Other Hyperthermia Malignant Professional Zoloft (Sertraline Overdose Company Hydrochloride) C Tachycardia Representative Trazodone C 24-Jun-2005 12:19 PM Page: 1254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3626831-3Report Type:Expedited (15-DaCompany Report #US-001154483 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 3 WK Prozac (Fluoxetine Hydrochloride) SS 20 MG/DAY Metorpolol C Levothyroxine C Effexor (Venlafaxine Hydrochloride) C Date:12/11/00ISR Number: 3626838-6Report Type:Expedited (15-DaCompany Report #US_000847251 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autoimmune Hepatitis Health Zyprexa PS Eli Lilly And Co 20 MG /1 DAY Hallucination Professional Zyprexa (Olanzapine) SS 2.5 MG/DAY Hepatitis Chronic Active Company Paxil C Representative Date:12/11/00ISR Number: 3626948-3Report Type:Expedited (15-DaCompany Report #EWC001108701 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Haemorrhage Study Diazepam C Haematemesis Health ... C Haemoglobin Decreased Professional Mania Other Date:12/11/00ISR Number: 3626949-5Report Type:Expedited (15-DaCompany Report #AU_000501403 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affective Disorder Foreign Lithium PS 6 DSG Initial or Prolonged Aggression Study FORM/DAY 33 DAY Agitation Health Placebo SS 4 DSG Alanine Aminotransferase Professional FORM/DAY Increased Other Olazapine SS 20 MG/DAY Anxiety Depression Irritability Mania Date:12/11/00ISR Number: 3627102-1Report Type:Expedited (15-DaCompany Report #GBS001106913 Age:71 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Other Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase 24-Jun-2005 12:19 PM Page: 1255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Jaundice Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 5 MG / 1 DAY Health Chlopromazine C Professional Cod Liver Oil C Other Date:12/11/00ISR Number: 3627103-3Report Type:Expedited (15-DaCompany Report #GBS001106956 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Zyprexa PS Eli Lilly And Co 15 MG / 1 DAY Initial or Prolonged Renal Failure Acute Health Professional Company Representative Other Date:12/11/00ISR Number: 3627104-5Report Type:Expedited (15-DaCompany Report #DE_001003278 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 20 MG / 1 DAY Health Benzodiazepine C Professional Other Date:12/11/00ISR Number: 3627105-7Report Type:Expedited (15-DaCompany Report #DE_001103383 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 20 MG / IN Initial or Prolonged Leukopenia Health THE EVENING Medication Error Professional Tavor C Neutropenia Other Date:12/11/00ISR Number: 3627168-9Report Type:Expedited (15-DaCompany Report #DE_001203597 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Phosphokinase Increased Health Rhabdomyolysis Professional Date:12/11/00ISR Number: 3627171-9Report Type:Expedited (15-DaCompany Report #DE_001103571 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mediastinum Neoplasm Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY 4 WK Initial or Prolonged Pericardial Effusion Health Professional Other 24-Jun-2005 12:19 PM Page: 1256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3627206-3Report Type:Expedited (15-DaCompany Report #GBS001106994 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Orthostatic Hypotension Health Professional Other Date:12/11/00ISR Number: 3627271-3Report Type:Expedited (15-DaCompany Report #EWC001108711 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Atrioventricular Block Health Haldol (Haloperidol) C Initial or Prolonged Blood Pressure Decreased Professional Valium (Diazepam) C Medication Error Company Psychopax (Diazepam) C Representative Anexate (Flumazenil) C Other Date:12/11/00ISR Number: 3627274-9Report Type:Expedited (15-DaCompany Report #EWC001108712 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Other Date:12/11/00ISR Number: 3627277-4Report Type:Expedited (15-DaCompany Report #GBS001106940 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Hepatitis Health Lithium Citrate C Other Jaundice Cholestatic Professional Lactulose C Neutrophilia Company Senna C Vomiting Representative White Blood Cell Count Other Increased Date:12/11/00ISR Number: 3627280-4Report Type:Expedited (15-DaCompany Report #GBS001106988 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa PS Eli Lilly And Co 10 MG IN THE Hospitalization - Hyponatraemia Health EVENING Initial or Prolonged Inappropriate Professional Chlorpromazine C Antidiuretic Hormone Other Secretion Respiratory Failure 24-Jun-2005 12:19 PM Page: 1257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3627354-8Report Type:Expedited (15-DaCompany Report #EWC001108697 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa PS Eli Lilly And Co 130 MG/DAY Initial or Prolonged Prolonged Health Trimipramine C Overdose Professional Company Representative Other Date:12/13/00ISR Number: 3627779-0Report Type:Direct Company Report # Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Olanzapine 7.5mg PS ORAL 7.5MG DAILY Initial or Prolonged Fall ORAL Lisinopril C Furosemide C Sertraline C Clonazepam C Date:12/15/00ISR Number: 3631526-6Report Type:Direct Company Report # Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Zyprexa 10mg Lilly PS Lilly ORAL 10MG QHS ORAL Gynaecomastia Oedema Peripheral Date:12/18/00ISR Number: 3631750-2Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Zyrtec PS Pfizer Head Injury Zyprexa SS Lilly Medication Error Date:12/18/00ISR Number: 3632833-3Report Type:Expedited (15-DaCompany Report #US_990319499 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Humulin R PS Eli Lilly And Co 5 U/IN THE Initial or Prolonged Diabetes Mellitus MORNING Inadequate Control Humulin-Human Lente Feeling Drunk Insulin (Rdna) Injection Site Reaction (Human Insulin (Rdna Localised Infection Origin)) SS 22 U/IN THE Obsessive-Compulsive MORNING Disorder Iletin-Insulin-Anima Postoperative Infection l (Unknown Scar Formulation) Sedation (Insulin, Animal) SS Skin Ulcer Zyprexa (Olanzapine) SS 2.5 MG/DAY Toe Amputation Klonopin Urinary Tract Infection (Clonazepam) C Wound Debridement Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/00ISR Number: 3633040-0Report Type:Expedited (15-DaCompany Report #PHEH2000US09071 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS Novartis Electrocardiogram Qt Professional Pharmaceuticals Corp ORAL 1000 MG, QD, Prolonged ORAL Overdose Serentil (Mesoridazine) SS Risperdal (Risperidone) SS Olanzapine (Olanzapine) SS Date:12/18/00ISR Number: 3633213-7Report Type:Expedited (15-DaCompany Report #DE_001203597 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Aminotransferase Health Atosil Increased Professional (Isopromethazine Blood Lactate Other Hydrochloride) C Dehydrogenase Increased Fluninoc Malaise (Flunitrazepam) C Rhabdomyolysis Date:12/18/00ISR Number: 3633219-8Report Type:Expedited (15-DaCompany Report #EWC000506724 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Fluoxetine Hcl PS Lilly Research Initial or Prolonged Exposure To Therapeutic Health Laboratories Div Eli Drugs Professional Lilly And Co Neonatal Disorder Company Zyprexa (Olanzapine) SS Sedation Representative Lysanxia (Prazepam) C Upper Respiratory Tract Other Infection Date:12/18/00ISR Number: 3633247-2Report Type:Expedited (15-DaCompany Report #EWC981001849 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY 3 WK Hospitalization - Coma Health Haldol(Haloperidol) C Initial or Prolonged Completed Suicide Professional Temesta(Lorazepam) C Convulsion Other Depakine(Valproate Pyrexia Sodium) C Date:12/18/00ISR Number: 3633346-5Report Type:Expedited (15-DaCompany Report #US_001254961 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Hypothermia Professional Neurontin Pneumonia (Gabapentin) C Thrombocytopenia 24-Jun-2005 12:19 PM Page: 1259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/00ISR Number: 3634037-7Report Type:Expedited (15-DaCompany Report #CA_001202411 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cleft Palate Foreign Zyprexa PS Eli Lilly And Co Congenital Anomaly Complications Of Maternal Health Other Exposure To Therapeutic Professional Drugs Company Heart Rate Decreased Representative Kidney Malformation Other Neonatal Disorder Polydactyly Date:12/18/00ISR Number: 3634042-0Report Type:Expedited (15-DaCompany Report #US_001255014 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Pleural Effusion Health Paroxetine C Professional Other Date:12/19/00ISR Number: 3632893-XReport Type:Expedited (15-DaCompany Report #A0134381A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Lamictal PS Glaxo Wellcome ORAL 200MG Twice Initial or Prolonged Anxiety per day 2 YR Bipolar Disorder Zyprexa SS Condition Aggravated Lithium SS Drug Effect Decreased Norvasc C Mood Altered Date:12/19/00ISR Number: 3633574-9Report Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Zyprexia PS ORAL DAILY ORAL Life-Threatening Ginko Biloba(Herbal) SS ORAL DAILY ORAL Hospitalization - Initial or Prolonged Disability Date:12/19/00ISR Number: 3634386-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU04439 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecaloma Foreign Mellaril PS Novartis Renal Failure Acute Health Pharmaceuticals Corp ORAL 400 MG/DAY, Professional ORAL Other Stelazine (Trifluoperazine Hydrochloride) SS 20 MG/DAY Olanzapine SS 5 MG/DAY Modecate "Squibb" (Fluphenazine Decanoate) SS 50 MG/MONTH Cogentin 24-Jun-2005 12:19 PM Page: 1260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) SS 2 MG/DAY Date:12/20/00ISR Number: 3635124-XReport Type:Expedited (15-DaCompany Report #A0134381A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Lamictal PS Glaxo Wellcome Inc ORAL 200 MG/ TWICE Initial or Prolonged Drug Ineffective Professional PER DAY/ ORAL 2 YR Olanzapine (Formulation Unknown) (Olanzapine) SS Lithium Salt (Formulation Unknown) (Lithium Salt) SS Amlodipine C Date:12/20/00ISR Number: 3635177-9Report Type:Expedited (15-DaCompany Report #200090214BWH Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Cipro PS Bayer Corp ORAL 1000 MG DAILY Drug Interaction Other ORAL Drug Level Above Zyprexa SS ORAL 10 MG DAILY Therapeutic ORAL Orchitis Synthroid C Sedation Alprazolam C Sleep Apnoea Syndrome Celexa C Ventricular Hypertrophy Lithium C Date:12/21/00ISR Number: 3635566-2Report Type:Direct Company Report # Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Zyprexa (10mg Hs Po) PS ORAL 10MG HS PO Sudden Death Buspar C Vit E C Motrin C Urospas C Date:12/21/00ISR Number: 3635724-7Report Type:Expedited (15-DaCompany Report #PHRM2000FR01831 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Intentional Misuse Health Pharmaceuticals Corp ORAL ORAL, 1800 Suicide Attempt Professional MG, Other ONCE/SINGLE, ORAL Zyprexa (Olanzapine) Tablet SS ORAL 200 MG, ONCE/SINGLE, ORAL 24-Jun-2005 12:19 PM Page: 1261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/00ISR Number: 3638208-5Report Type:Expedited (15-DaCompany Report #US_001153999 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Eli Lilly And Co 150 MG/DAY Intentional Misuse Professional Ativan C Ibuprofen C Vitamin E C Paroxetine C Date:12/26/00ISR Number: 3638668-XReport Type:Expedited (15-DaCompany Report #US_001051262 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Health Zyprexa PS Eli Lilly And Co 30 MG/DAY 1 YR Increased Professional Depakote (Valproate Blood Glucose Increased Company Semisodium) C Pancreatitis Acute Representative Hydrochlorothiazide C Date:12/26/00ISR Number: 3638738-6Report Type:Expedited (15-DaCompany Report #US_001255486 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Zyprexa PS Eli Lilly And Co Professional Benztropine C Other Date:12/26/00ISR Number: 3638739-8Report Type:Expedited (15-DaCompany Report #US_001255372 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Consumer Zyprexa PS Eli Lilly And Co 95 MG/1 DAY Wellbutrin (Amfebutamone Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Date:12/26/00ISR Number: 3638741-6Report Type:Expedited (15-DaCompany Report #US_001255115 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Health Zyprexa PS Eli Lilly And Co Exposure To Therapeutic Professional Prozac (Fluoxetine Drugs Hydrochloride) SS Pregnancy Stillbirth Date:12/26/00ISR Number: 3638785-4Report Type:Expedited (15-DaCompany Report #A039625 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zoloft PS Pfizer Hyperthermia Malignant Professional Pharmaceuticals Inc ORAL 1000.00 MG Overdose TOTAL: ORAL Respiratory Arrest Zyprexa SS ORAL 260.00 MG Tachycardia TOTAL:ORAL 24-Jun-2005 12:19 PM Page: 1262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone SS ORAL 200.00 MG TOTAL:ORAL Date:12/26/00ISR Number: 3639319-0Report Type:Expedited (15-DaCompany Report #US_001255908 Age:19 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa PS Eli Lilly And Co Exposure To Therapeutic Professional Prenatal C Drugs Developmental Delay Failure To Thrive Microcephaly Date:12/26/00ISR Number: 3640111-1Report Type:Expedited (15-DaCompany Report #DE_001103449 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Atrial Septal Defect Foreign Zyprexa PS Eli Lilly And Co TRANSPLACENTAL Benign Congenital Health Tavor C TRANSPLACENTAL Hypotonia Professional Complications Of Maternal Other Exposure To Therapeutic Drugs Drug Withdrawal Syndrome Neonatal Fatigue Tremor Neonatal Date:12/26/00ISR Number: 3640112-3Report Type:Expedited (15-DaCompany Report #DE_001203597 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Aminotransferase Health Atosil C Increased Professional Fluinoc C Blood Creatine Other Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Blood Lactate Dehydrogenase Increased Date:12/26/00ISR Number: 3640114-7Report Type:Expedited (15-DaCompany Report #DE_001203812 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co Health Professional Other 24-Jun-2005 12:19 PM Page: 1263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/00ISR Number: 3640116-0Report Type:Expedited (15-DaCompany Report #EWC001208956 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Fraxiparine C Professional Other Date:12/26/00ISR Number: 3640117-2Report Type:Expedited (15-DaCompany Report #EWC001208977 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Previscan C Professional Fer "Ucb" (Ferrous Other Chloride) C Date:12/26/00ISR Number: 3640153-6Report Type:Expedited (15-DaCompany Report #EWC001209096 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Sedation Health Dominal Professional (Prothipendyl Other Hydrochloride) C Date:12/26/00ISR Number: 3640218-9Report Type:Expedited (15-DaCompany Report #DE_001204153 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arterial Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Compartment Syndrome Health Stilnox C Disability Diplopia Professional Kliogest C Neuroleptic Malignant Other Syndrome Rhabdomyolysis Scar Date:12/26/00ISR Number: 3640226-8Report Type:Expedited (15-DaCompany Report #GBS990603479 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Hospitalization - Respiratory Failure Literature Initial or Prolonged Health Professional Date:12/26/00ISR Number: 3640228-1Report Type:Expedited (15-DaCompany Report #GBS000205354 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Drug Level Above Health Reboxetine C Therapeutic Professional Clonazepam C Company Representative 24-Jun-2005 12:19 PM Page: 1264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/00ISR Number: 3640229-3Report Type:Expedited (15-DaCompany Report #DE_000602572 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Escherichia Infection Health Cynt (Moxonidine) C Petechiae Professional Nephrotrans (Sodium Pruritus Other Bicarbonate) C Pyrexia Akineton (Biperidin) C Shock Maninil C Urinary Tract Infection Vitaferro C Date:12/26/00ISR Number: 3640233-5Report Type:Expedited (15-DaCompany Report #GBS001207583 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Foreign Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Initial or Prolonged Literature Sulpiride C Health Professional Date:12/26/00ISR Number: 3640408-5Report Type:Expedited (15-DaCompany Report #EWC001209236 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Intentional Misuse Health Professional Other Date:12/26/00ISR Number: 3640409-7Report Type:Expedited (15-DaCompany Report #EWC001209237 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Drug Level Above Other Therapeutic Intentional Misuse Date:12/26/00ISR Number: 3640410-3Report Type:Expedited (15-DaCompany Report #EWC001209101 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Sedation Health Haldol(Haloperidol) C Professional Dominal(Prothipendyl Other Hydrochloride) C Date:12/27/00ISR Number: 3638912-9Report Type:Expedited (15-DaCompany Report #EWC001108686 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Abnormal Health Artane Professional (Trihexyphenidyl Company Hydrochloride) C Representative Zoloft (Sertraline 24-Jun-2005 12:19 PM Page: 1265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Tenormin (Atenolol) C Eurodin (Estazolam) C Magnesium Oxide C Date:12/27/00ISR Number: 3638914-2Report Type:Expedited (15-DaCompany Report #EWC001108701 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Upper Gastrointestinal Study Diazepam C Haemorrhage Health Professional Other Date:12/27/00ISR Number: 3640110-XReport Type:Expedited (15-DaCompany Report #AU_001202472 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co Hyperhidrosis Health Cipramil C Oxygen Saturation Professional Decreased Company Pallor Representative Other Date:12/27/00ISR Number: 3640113-5Report Type:Expedited (15-DaCompany Report #DE_001203797 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Initial or Prolonged Pancytopenia Health Professional Other Date:12/27/00ISR Number: 3640115-9Report Type:Expedited (15-DaCompany Report #EWC001209138 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Depression Health Largactil C Drowning Professional Vival C Drug Abuser Other Paranoia Psychotic Disorder Date:01/02/01ISR Number: 3640254-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zydis -Olanzapine PS Zydis -Apomorphine- SS 24-Jun-2005 12:19 PM Page: 1266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/01ISR Number: 3642846-3Report Type:Expedited (15-DaCompany Report #2000UW03450 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS Astrazeneca Initial or Prolonged Dermatitis Contact Professional Pharmaceuticals Lp ORAL 100 MG BID PO Drug Interaction Zyprexa SS 5 MG BID Dystonia Effexor SS Pruritus Weight Increased Date:01/08/01ISR Number: 3643582-XReport Type:Expedited (15-DaCompany Report #DE_001204153 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Compartment Syndrome Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Diplopia Health Stilnox (Zolpidem) C Initial or Prolonged Feeling Cold Professional Kliogest C Pain In Extremity Other Paraesthesia Pyrexia Rhabdomyolysis Tachycardia Thrombosis Date:01/08/01ISR Number: 3643583-1Report Type:Expedited (15-DaCompany Report #DE_001203797 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Folate Deficiency Health Pancytopenia Professional Other Date:01/08/01ISR Number: 3643584-3Report Type:Expedited (15-DaCompany Report #GBS001006780 Age:4 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Accidental Overdose Health Ventolin Other Aggression Professional (Salbutamol) C Circulatory Collapse Other Becotide Convulsion (Beclometasone Coordination Abnormal Dipropionate) C Dystonia Mood Altered Sedation Date:01/08/01ISR Number: 3643586-7Report Type:Expedited (15-DaCompany Report #GBS000205354 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Reboxetine C Professional Clonazepam C Company Representative Other 24-Jun-2005 12:19 PM Page: 1267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/01ISR Number: 3643590-9Report Type:Expedited (15-DaCompany Report #US_001255860 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prothrombin Time Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 DAY Prolonged Professional Claritin (Loratadine) C Coumadin (Warfarin Sodium) C Atenolol C Accupril (Quinapril Hydrochloride) C Date:01/08/01ISR Number: 3643653-8Report Type:Expedited (15-DaCompany Report #PHRM2000FR01831 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Clonic Convulsion Health Pharmaceuticals Corp ORAL ORAL Intentional Misuse Professional Zyprexa (Olanzapine) SS ORAL 200 MG, Microcytic Anaemia Other ONCE/SINGLE , Suicide Attempt ORAL Artane (Trihexyphenidyl Hydrochloride) SS Date:01/08/01ISR Number: 3643784-2Report Type:Expedited (15-DaCompany Report #PHNU2000DE02414 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Anafranil PS Novartis Hospitalization - Consciousness Study Pharmaceuticals Corp ORAL 25 MG/DAY, Initial or Prolonged Diabetic Hyperosmolar Health ORAL ; 50 Coma Professional MG/DAY, ORAL Extrapyramidal Disorder Other Zyprexa (Olanzapine) SS ORAL 20 MG/DAY, Hypertension ORAL Mental Disorder Due To A Quilonum (Lithium General Medical Condition Acetate) C Pneumonia Pyrexia Renal Failure Restlessness Rhabdomyolysis Tachycardia Tachypnoea Date:01/08/01ISR Number: 3644383-9Report Type:Expedited (15-DaCompany Report #GBS001207621 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 1268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/01ISR Number: 3644385-2Report Type:Expedited (15-DaCompany Report #EWC010109676 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Pharyngeal Oedema Health Rash Generalised Professional Company Representative Other Date:01/08/01ISR Number: 3644386-4Report Type:Expedited (15-DaCompany Report #EWC001209440 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Health Professional Other Date:01/08/01ISR Number: 3644388-8Report Type:Expedited (15-DaCompany Report #EWC001209401 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Steatosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Leukocytosis Health Haloperidol C Liver Function Test Professional Abnormal Other Weight Increased Date:01/08/01ISR Number: 3644390-6Report Type:Expedited (15-DaCompany Report #DE_001204174 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Petechiae Health Cynt-.(Moxonidine) SS 0.1 MG/1 IN Pruritus Professional THE EVENING Shock Other Nephrotrans (Sodium Urinary Tract Infection Bicarbonate) C Akineton (Biperiden Hydrochloride) C Maninil C Vitaferro C Date:01/08/01ISR Number: 3644473-0Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Olanzapine PS Date:01/08/01ISR Number: 3644478-XReport Type:Expedited (15-DaCompany Report #DE_000602572 Age:66 YR Gender:Female I/FU:F Outcome PT Hospitalization - Escherichia Infection Initial or Prolonged Petechiae Pyrexia 24-Jun-2005 12:19 PM Page: 1269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Pruritic Shock Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Cynt (Moxonidine) C Professional Nephrotrans (Sodium Other Bicarbonate Hydrochloride) C Vitaferro C Date:01/08/01ISR Number: 3644480-8Report Type:Expedited (15-DaCompany Report #AU_001202678 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Goitre Study Voltaren (Diclofenac Health Sodium) C Professional Date:01/08/01ISR Number: 3644581-4Report Type:Expedited (15-DaCompany Report #US_001154483 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 3 WK Prozac (Olanzapine) SS 20 MG/DAY Metoprollol C Effexor (Venlafaxine Hydrochloride) C Levothyroxine C Date:01/09/01ISR Number: 3643578-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Neurontin PS Zyprexa SS Date:01/09/01ISR Number: 3644639-XReport Type:Expedited (15-DaCompany Report #200090214BWH Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Chloride Increased Consumer Cipro PS Bayer Corp ORAL 1000 MG DAILY Blood Ethanol Increased Other ORAL Blood Potassium Increased Zyprexa SS ORAL 10 MG DAILY Blood Sodium Increased ORAL Coma Synthroid C Completed Suicide Alprazolam C Drug Interaction Celexa C Drug Level Above Lithium C Therapeutic Depakote C Overdose Sedation Ventricular Hypertrophy 24-Jun-2005 12:19 PM Page: 1270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/01ISR Number: 3655020-1Report Type:Periodic Company Report #US_000848122 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Evista PS Eli Lilly And Co 60 MG/1 DAY 3 MON Zyprexa SS 20 MG DAILY 18 MON Lithium Carbonate C 750 MG/1 DAY Promethazine C Fexofenadine Hydrochloride C Tetracycline C Vitamin C C Aspirin C Date:01/10/01ISR Number: 3645453-1Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Zyrexia 10mg PS ORAL 1T HS PO Phobia Date:01/10/01ISR Number: 3645582-2Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Zyprexa 10mg PS 10 MG HS Weight Increased Celexa C Klonopin C Depakote C Date:01/16/01ISR Number: 3648127-6Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Olanzapine PS ORAL 2.5MG Q AM Joint Stiffness AND 5 MG Q HS Movement Disorder Benztropine C Nervousness Methylphenidate C Restlessness Tremor Date:01/16/01ISR Number: 3648207-5Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Olanzapine (10mg) PS ORAL 10MG QHS PO Initial or Prolonged Valproex C Oxybutynin C Trazadone C Date:01/16/01ISR Number: 3648229-4Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Olanzapine PS ORAL 10MG Q HS Venlafaxine C 24-Jun-2005 12:19 PM Page: 1271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/01ISR Number: 3648235-XReport Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Jittery Quetiapine PS ORAL 200MG BID PO Muscle Rigidity Olanzapine SS ORAL 10 MG Q AM AND 15 MG Q HS PO Lorazepam C Benztropine C Mvi C Guiafenesin C Apap C Date:01/17/01ISR Number: 3649172-7Report Type:Expedited (15-DaCompany Report #US_001152844 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Health Zyprexa PS Eli Lilly And Co 20 MG/AT Urinary Tract Infection Professional BEDTIME Zoloft(Sertraline Hydrochloride) C Cogentin(Benzatropin e Mesilate) C Date:01/17/01ISR Number: 3649438-0Report Type:Expedited (15-DaCompany Report #2000UW03450 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS Astrazeneca Initial or Prolonged Dermatitis Contact Professional Pharmaceuticals Lp ORAL 100 MG BID PO Drug Interaction Zyprexa SS 5 MG BID Dystonia Effexor SS Pruritus Haloperidal SS INTRAMUSCULAR 10 MG IM Torticollis Vomiting Weight Increased Date:01/17/01ISR Number: 3649706-2Report Type:Expedited (15-DaCompany Report #DE_001103449 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Atrial Septal Defect Foreign Zyprexa PS Eli Lilly And Co Caesarean Section Health Tavor C Complications Of Maternal Professional Exposure To Therapeutic Other Drugs Fatigue Neonatal Disorder Tremor Neonatal Date:01/17/01ISR Number: 3649708-6Report Type:Expedited (15-DaCompany Report #AU_001202678 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Hospitalization - Condition Aggravated Foreign Initial or Prolonged Dysphagia Study Goitre Health 24-Jun-2005 12:19 PM Page: 1272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 10 MG/DAY Voltaren C Date:01/17/01ISR Number: 3649709-8Report Type:Expedited (15-DaCompany Report #DE_001203597 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Aminotransferase Health Atosil C Increased Professional Fluninoc C Blood Creatine Other Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Blood Lactate Dehydrogenase Increased Rhabdomyolysis Date:01/18/01ISR Number: 3650337-9Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Zyprexa Lilly PS Lilly ORAL 25MG PO Q PM Sudden Death Celexa Forest SS Forest ORAL 40MG PO Q AM Date:01/18/01ISR Number: 3650631-1Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Zyprexa 15mg 2tt Hypersomnia Lilly PS Lilly ORAL 15MG PO 2TT Sudden Death GHS MDD WITH 9 MON Date:01/18/01ISR Number: 3650632-3Report Type:Direct Company Report # Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Zyprexa 5mg Lilly PS Lilly ORAL 5MG PO Q HS Sudden Death Date:01/18/01ISR Number: 3650635-9Report Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zyprexa PS Lilly ORAL 10MG PO TID Effexor C Haldol C Lozestin C Neurotin C Ativin C Neupoxen C Zocor C 24-Jun-2005 12:19 PM Page: 1273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tegretol C Accupril C Tagamet C Amitriptylene C Date:01/19/01ISR Number: 3650629-3Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Olanzapine PS ORAL 20MG,20M QD Initial or Prolonged Syndrome ORAL Haloperidol 5mg/Ml Inj, Soln SS INTRAMUSCULAR 2.5MG Q6H IM Date:01/19/01ISR Number: 3651534-9Report Type:Expedited (15-DaCompany Report #US_010157185 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Strangulated Health Zyprexa PS Eli Lilly And Co 15 MG/1 AT Other Hernia Professional BEDTIME Drug Level Above Company Clozaril (Clozapine) C Therapeutic Representative Klonopin Gastrointestinal Necrosis (Clonazepam) C Umbilical Hernia Fosinopril C Depakote (Valproate Semisodium) C Atenolol C Date:01/19/01ISR Number: 3651556-8Report Type:Expedited (15-DaCompany Report #US_010157263 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Zyprexa PS Eli Lilly And Co Decreased Professional Depakote C White Blood Cell Count Decreased Date:01/19/01ISR Number: 3651557-XReport Type:Expedited (15-DaCompany Report #US_010157242 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Abnormal Literature Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Clozapine C Professional Divalproex Sodium C Nifedipine C Metformin C Insulin C Ativan C Date:01/19/01ISR Number: 3651592-1Report Type:Expedited (15-DaCompany Report #DE_010104555 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Drug Interaction Foreign Initial or Prolonged Pancreatitis Health Professional 24-Jun-2005 12:19 PM Page: 1274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 10 MG/DAY Leponex (Clozapine) C Seroxat (Paroxetine Hydrochloride) C Pirenzepine C Date:01/19/01ISR Number: 3651593-3Report Type:Expedited (15-DaCompany Report #DE_010104712 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Foreign Zyprexa PS Eli Lilly And Co Health Professional Other Date:01/19/01ISR Number: 3652009-3Report Type:Expedited (15-DaCompany Report #US_010157213 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 40 DAY Neutropenia Literature Chlorprothixene C Health Clonazepam C Professional Orphenadrine C Other Date:01/19/01ISR Number: 3652012-3Report Type:Expedited (15-DaCompany Report #US_010157204 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/1 DAY 24 DAY Neutropenia Literature Zuclopenthixol C Health Clonazepam C Professional Other Date:01/19/01ISR Number: 3652509-6Report Type:Expedited (15-DaCompany Report #US_010156893 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY Hospitalization - Condition Aggravated Health Fluvoxamine C Initial or Prolonged Confusional State Professional Depakote (Valproate Difficulty In Walking Semisodium) C Extrapyramidal Disorder Clonazepam C Hallucination, Auditory Insomnia Neuroleptic Malignant Syndrome Paranoia Sedation 24-Jun-2005 12:19 PM Page: 1275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/01ISR Number: 3652511-4Report Type:Expedited (15-DaCompany Report #US_010157038 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Completed Suicide Other Ciprofloaxcin C Drug Interaction Levothyroxine Sodium C Drug Level Above Alprazolam C Therapeutic Celexa (Citalopram Overdose Hydrobromide) C Sedation Lithium C Ventricular Hypertrophy Date:01/19/01ISR Number: 3652513-8Report Type:Expedited (15-DaCompany Report #US_010157105 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS Eli Lilly And Co 15 MG/2 DAY Initial or Prolonged Dizziness Professional Quetiapine C Joint Stiffness Klonopin Weight Increased (Clonazepam) C Tegretol (Carbamazepine) C Remeron (Mirtazapine) C Haldol (Haloperidol) C Date:01/22/01ISR Number: 3651255-2Report Type:Expedited (15-DaCompany Report #B0092065A Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Maculo-Papular Valaciclovir Initial or Prolonged Rash Pustular Hydrochloride PS Glaxo Wellcome ORAL 12 DAY Olanzapine SS ORAL Chlorhexidine C TOPICAL Depamide C ORAL 900MG per day Rohypnol C ORAL Tercian C ORAL 75MG per day Date:01/22/01ISR Number: 3651465-4Report Type:Direct Company Report # Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Olanzepine PS 10MG HS ? Initial or Prolonged MONTHS OF TRX= POOR HISTORY Dilantin C Coumadin C Date:01/22/01ISR Number: 3652245-6Report Type:Expedited (15-DaCompany Report #02266 Age:23 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Trazodone Hcl PS Purepac Pharmaceutical Co Div Purepac Inc ORAL ORAL Olanzapine SS ORAL ORAL 24-Jun-2005 12:19 PM Page: 1276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluoxetine SS ORAL ORAL Date:01/22/01ISR Number: 3652251-1Report Type:Expedited (15-DaCompany Report #02303 Age:35 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil Hcl PS Purepac Intentional Misuse Pharmaceutical Co Div Purepac Inc ORAL ORAL Amitriptyline SS ORAL ORAL Olanzapine SS ORAL ORAL Date:01/23/01ISR Number: 3653852-7Report Type:Expedited (15-DaCompany Report #B0092065A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Maculo-Papular Foreign Valtrex PS Glaxo Wellcome Inc ORAL 500 MG ORAL Initial or Prolonged Rash Pustular Olanzapine (Olanzapine) SS ORAL ORAL Chlorhexidine C Valpromide C Flunitrazepam C Cyamemazine C Date:01/24/01ISR Number: 3653350-0Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zyprexa 15 Mg 1 Hs PS 1 HS Zyprexa 5 Mg 1 Middle Of Night Prn Sleep SS MIDDLE OF NIGHT PRN SLEEP Prozac C Remeron C Klonopan C Trozadone C Date:01/25/01ISR Number: 3655222-4Report Type:Expedited (15-DaCompany Report #US_001154200 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Health Zyprexa PS Eli Lilly And Co 400 MG/DAY Other Cardio-Respiratory Arrest Professional Zoloft C Hyperthermia Malignant Company Trazodone C Neuroleptic Malignant Representative Syndrome Overdose Suicide Attempt Ventricular Fibrillation 24-Jun-2005 12:19 PM Page: 1277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/01ISR Number: 3655237-6Report Type:Expedited (15-DaCompany Report #US_000950243 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Consumer Zyprexa PS Eli Lilly And Co UNKNOWN 15 MG 1 DAY Initial or Prolonged Mania UNKNOWN Narcolepsy Depakote (Valproate Weight Increased Semisodium) C Date:01/25/01ISR Number: 3655238-8Report Type:Expedited (15-DaCompany Report #US_010157428 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Zyprexa PS Eli Lilly And Co UNKNOWN 10 MG 4 DAY Condition Aggravated UNKNOWN 2 YR Injury Lithonate (Lithium Optic Atrophy Carbonate) C Parkinsonism Eskalith (Lithium Scleral Disorder Carbonate) C Visual Acuity Reduced Luvox (Fluvoxamine Maleate) C Zaditor (Ketotifen) C Allegra (Fexofenadine Hydrochloride) C Synthroid (Levothyroxine Sodium) C Nasonex (Mometasone Furoate) C Date:01/25/01ISR Number: 3655658-1Report Type:Expedited (15-DaCompany Report #US_000235316 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Professional Paxil (Paroxetine Hydrochloride) C Date:01/25/01ISR Number: 3655684-2Report Type:Expedited (15-DaCompany Report #US_010157699 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Literature Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Neutropenia Health Weight Increased Professional Date:01/25/01ISR Number: 3655698-2Report Type:Expedited (15-DaCompany Report #US_001052548 Age:56 YR Gender:Female I/FU:I Outcome PT Blood Cholesterol Increased Blood Glucose Increased Blood Thyroid Stimulating Hormone Increased Blood Triglycerides Increased 24-Jun-2005 12:19 PM Page: 1278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Pain Condition Aggravated Ketonuria Report Source Product Role Manufacturer Route Dose Duration Low Density Lipoprotein Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Increased Professional Zantac (Ranitidine Weight Increased Hydrochloride) C White Blood Cell Count Estrace (Estradiol) C Increased Synthroid (Levothyroxine Sodium) C Depakote (Valproate Semisodium) C Lipitor (Atorvastatin) C Iron Sulfate C Vitaminc C Toprol Xl (Metoprolol Succinate) C Date:01/25/01ISR Number: 3655699-4Report Type:Expedited (15-DaCompany Report #US_010157546 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Eating Disorder Professional Aricept (Donepezil Hallucination Hydrochloride) C Psychotic Disorder Lanoxin (Digoxin) C Sleep Disorder Norvasc (Amlodipine Besilate0 C Avalide C Catapressan (Clonidine) C Date:01/25/01ISR Number: 3655701-XReport Type:Expedited (15-DaCompany Report #US_010157695 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Literature Zyprexa PS Eli Lilly And Co 30 MG/1 DAY 2 WK White Blood Cell Count Health Decreased Professional Date:01/25/01ISR Number: 3655703-3Report Type:Expedited (15-DaCompany Report #US_010157728 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Study Zyprexa PS Eli Lilly And Co 6 MG/1 IN THE Initial or Prolonged Blood Potassium Decreased Health EVENING Blood Urea Abnormal Professional Fluoxetine Dizziness (Fluoxetine Headache Hydrochloride) SS 50 MG/1 IN Hyperhidrosis THE EVENING Nausea Ziac C Subarachnoid Haemorrhage Progesterone C Ventricular Extrasystoles Premarin (Estrogens Vomiting Conjugated) C White Blood Cell Count Flovent (Fluticasone Increased Propionate) C 24-Jun-2005 12:19 PM Page: 1279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alupent (Orciprenaline Sulfate) C Ativan (Lorazepam) C Date:01/25/01ISR Number: 3655722-7Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Olanzapine 7.5mg Tablets Lilly PS Lilly ORAL 7.5MG/37.5 AM HS ORAL Date:01/25/01ISR Number: 3655773-2Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Olanzapine 10mg Qd PS Initial or Prolonged Syndrome Valproic Acid C Estrogen C Alprazolam C Date:01/25/01ISR Number: 3656063-4Report Type:Expedited (15-DaCompany Report #CA_010103029 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Health Elavil Professional (Amitriptyline Company Hydrochloride) C Representative Tegretol Other (Carbamazepine) C Duralith (Lithium Carbonate) C Date:01/25/01ISR Number: 3656064-6Report Type:Expedited (15-DaCompany Report #DE_010104696 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa PS Eli Lilly And Co 20 MG /DAY Cardiac Arrest Health Diazepam C Convulsion Professional Sinupret C Dyspnoea Other Restlessness Vomiting Date:01/25/01ISR Number: 3656065-8Report Type:Expedited (15-DaCompany Report #EWC010125029 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Health Tranxene(Clorazepate Professional Dipotassium) C Other Tercian (Cyamemazine) C 24-Jun-2005 12:19 PM Page: 1280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/01ISR Number: 3655695-7Report Type:Expedited (15-DaCompany Report #US_010157369 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Increased Professional Adderall C Dermatitis Lithium C Dermatitis Exfoliative Clonidine C Infectious Mononucleosis Risperdal Liver Function Test (Risperidone) C Abnormal Lymphadenopathy Pyrexia Date:01/30/01ISR Number: 3657539-6Report Type:Expedited (15-DaCompany Report #AU_010102923 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Zyprexa PS Eli Lilly And Co 30 MG/DAY Initial or Prolonged Health Epilim (Valproate Professional Sodium) C Other Date:01/30/01ISR Number: 3657569-4Report Type:Expedited (15-DaCompany Report #GBS001106994 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/IN THE Initial or Prolonged Fall Health EVENING Femur Fracture Professional Aspirin C Orthostatic Hypotension Other Lansoprazole C Haloperridol C Date:01/30/01ISR Number: 3657570-0Report Type:Expedited (15-DaCompany Report #GBS000205354 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa PS Eli Lilly And Co Brain Oedema Health Reboxetine C Completed Suicide Professional Coronary Artery Disease Company Hepatic Congestion Representative Overdose Other Date:01/30/01ISR Number: 3657606-7Report Type:Expedited (15-DaCompany Report #DE_010104813 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholestasis Foreign Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 1281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/01ISR Number: 3657609-2Report Type:Expedited (15-DaCompany Report #GBS010108112 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Other Date:01/30/01ISR Number: 3657610-9Report Type:Expedited (15-DaCompany Report #EWC990703815 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Neutropenia Literature Leponex C Health Professional Other Date:01/30/01ISR Number: 3657614-6Report Type:Expedited (15-DaCompany Report #DE_010104807 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Increased Health Myocardial Ischaemia Professional Other Date:01/30/01ISR Number: 3657635-3Report Type:Expedited (15-DaCompany Report #EWC010125128 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Increased Health Pertofran C Aspartate Professional Aminotransferase Company Increased Representative Blood Alkaline Other Phosphatase Increased Gamma-Glutamyltransferase Increased Date:01/30/01ISR Number: 3657647-XReport Type:Expedited (15-DaCompany Report #EWC010125211 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Medication Error Health Haloperidol C Professional Date:01/30/01ISR Number: 3657654-7Report Type:Expedited (15-DaCompany Report #DE_010104832 Age: Gender:Male I/FU:I Outcome PT Death Complications Of Maternal Exposure To Therapeutic Drugs 24-Jun-2005 12:19 PM Page: 1282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stillbirth Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co Health Truxal C Professional Date:01/30/01ISR Number: 3657655-9Report Type:Expedited (15-DaCompany Report #GBS010108062 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Initial or Prolonged Abnormal Health Aspirin C Hypotension Professional Ranitidine C Hypoxia Other Bendrofluazide C Liver Function Test Zopiclone C Abnormal Renal Impairment Date:01/30/01ISR Number: 3657659-6Report Type:Expedited (15-DaCompany Report #EWC001108711 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Atrioventricular Block Health Haldol C Initial or Prolonged Blood Pressure Decreased Professional Valium C Bradycardia Company Psychopax C Electrocardiogram Representative Anexate C Abnormal Date:01/30/01ISR Number: 3657673-0Report Type:Expedited (15-DaCompany Report #GBS991104712 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Grand Mal Convulsion Literature Clopixol C Humerus Fracture Health Professional Other Date:01/30/01ISR Number: 3657677-8Report Type:Expedited (15-DaCompany Report #EWC000807737 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 0.5 MG/DAY Literature Semap C Health Orap C Professional Leponex C Other Lithium Carbonate C Date:01/30/01ISR Number: 3657772-3Report Type:Expedited (15-DaCompany Report #US_010157866 Age:77 YR Gender:Male I/FU:I Outcome PT Other Electrocardiogram Qt Corrected Interval 24-Jun-2005 12:19 PM Page: 1283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co 5 MG/3 DAY Professional Haldol (Haloperidol) C Lamotrigine C Potassium C Nifedipine - Slow Release (Nifedipine) C Buspirone C Aspirin Enteric Coated K.P.(Acetylsalicylic Acid) C Triamterene And Hydrochlorothiazid "Harris" C Date:01/30/01ISR Number: 3657773-5Report Type:Expedited (15-DaCompany Report #US_010157965 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 3 DSG Initial or Prolonged Health FORM/DAY Professional Neosporin Ointment C Chloral Hydrate C Tylenol (Paracetamol) C Date:01/30/01ISR Number: 3658784-6Report Type:Expedited (15-DaCompany Report #US_001255115 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Health Zyprexa PS Eli Lilly And Co Exposure To Therapeutic Professional Prozac (Fluoxetine Drugs Hydrochloride) SS Stillbirth Date:01/30/01ISR Number: 3658785-8Report Type:Expedited (15-DaCompany Report #US_010157038 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Chloride Increased Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Blood Glucose Decreased Other Ciprofloxacin C Blood Potassium Increased Levothyroxine Sodium C Blood Sodium Increased Alprazolam C Cardiomegaly Celexa C Coma Lithium C Completed Suicide Depakote C Drug Interaction Drug Level Above Therapeutic Intentional Misuse Laboratory Test Abnormal Sedation 24-Jun-2005 12:19 PM Page: 1284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/01ISR Number: 3658786-XReport Type:Expedited (15-DaCompany Report #US_001255372 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Consumer Zyprexa PS Eli Lilly And Co 237.5 MG/1 Initial or Prolonged Health DAY Professional Wellbutrin C Effexor C Date:02/02/01ISR Number: 3661494-2Report Type:Periodic Company Report #FLUV00200006125 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Luvox PS Solvay Hyperglycaemia Pharmaceuticals ORAL 100 MG TID PO Hyperhidrosis Zyprexa (Olanzapine) SS ORAL 12.5 MG DAILY Hypoglycaemia PO Menorrhagia Alprazolam Weight Increased (Alprazolam) C Buspar (Buspirone Hydrochloride) C Date:02/02/01ISR Number: 3662048-4Report Type:Periodic Company Report #FLUV00200002039 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Luvox (Fluvoxamine Anxiety Professional Maleate) PS ORAL SEE IMAGE Paraesthesia Company Zyprexa (Olanzapine) SS ORAL QD PO Tremor Representative Neurontin (Gabapentin) C Ativan (Lorazepam) C Date:02/02/01ISR Number: 3663307-1Report Type:Periodic Company Report #FLUV00200006077 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Luvox PS Solvey Hallucination Professional Pharmaceuticals, Sedation Inc. ORAL 150 MG DAILY PO, 300 MG DAILY, PO Zypress (Olanzapine) SS ORAL DAILY PO Risperdal (Risperidone) C Anapranil (Clomipramine Hydrochloride) C Date:02/05/01ISR Number: 3659732-5Report Type:Direct Company Report # Age:46 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 24-Jun-2005 12:19 PM Page: 1285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Olanzapine PS 5MGM AM 15MGM Influenza Like Illness HS Date:02/05/01ISR Number: 3661093-2Report Type:Expedited (15-DaCompany Report #A039625 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Health Zoloft PS Pfizer Cardio-Respiratory Arrest Professional Pharmaceuticals Inc ORAL ORAL Completed Suicide Zyprexa SS ORAL 260.00 MG Hyperthermia Malignant TOTAL: ORAL Neuroleptic Malignant Trazodone SS ORAL 150.00 MG Syndrome TOTAL: ORAL Overdose Tachycardia Date:02/05/01ISR Number: 3661284-0Report Type:Expedited (15-DaCompany Report #US_000745696 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apgar Score Low Consumer Zyprexa PS Eli Lilly And Co TRANSPLACENTAL Other Complications Of Maternal Health Paxil (Paroxetine Exposure To Therapeutic Professional Hydrochloride) C TRANSPLACENTAL Drugs Depakote (Valproate, Lethargy Semisodium) C TRANSPLACENTAL Neonatal Apnoeic Attack Haldol (Haloperidol) C TRANSPLACENTAL Neonatal Disorder Marijuana C TRANSPLACENTAL Date:02/05/01ISR Number: 3661286-4Report Type:Expedited (15-DaCompany Report #US_000745687 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa PS Eli Lilly And Co 10 MG/AT Initial or Prolonged Health BEDTIME Professional Paxil (Paroxetine Hydrochloride) C Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Date:02/05/01ISR Number: 3661289-XReport Type:Expedited (15-DaCompany Report #US_000541276 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Health Zyprexa PS Eli Lilly And Co Other Arrhythmia Professional Estazolam C Respiratory Distress Ventricular Hypertrophy 24-Jun-2005 12:19 PM Page: 1286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/01ISR Number: 3661337-7Report Type:Expedited (15-DaCompany Report #US_990319499 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Humulin -Human Lente Initial or Prolonged Coronary Artery Surgery Insulin (Rdna) Diabetes Mellitus (Human Insulin (Rdna Hypoglycaemia Origin) ) PS 38 U/DAY Injection Site Reaction Humulin-Human Localised Infection Regular Insulin Obsessive-Compulsive (Rdna) (Human Disorder Insulin (Rdna Postoperative Infection Origin) ( SS 5 U/IN THE Scar MORNING Sedation Iletin-Insulin-Anima Skin Ulcer l (Unknown Toe Amputation Formulation) Urinary Tract Infection (Insulin, Animal) SS Zyprexa (Olanzapine) SS 2.5 MG/DAY Humalog-.(Lispro) SS 28 U/DAY Klonopin (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Date:02/05/01ISR Number: 3662484-6Report Type:Expedited (15-DaCompany Report #US_001255014 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Initial or Prolonged Pleural Effusion Health Paroxetine C Pneumonia Professional Other Date:02/05/01ISR Number: 3663100-XReport Type:Expedited (15-DaCompany Report #DE_010104712 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Essential Foreign Zyprexa PS Eli Lilly And Co Thrombocythaemia Health Professional Other Date:02/05/01ISR Number: 3663101-1Report Type:Expedited (15-DaCompany Report #DE_010104807 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa PS Pfizer Laboratories Initial or Prolonged Myocardial Ischaemia Health Div Pfizer Inc 20 MG/DAY Professional Other Date:02/05/01ISR Number: 3663102-3Report Type:Expedited (15-DaCompany Report #EWC010109676 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Oedema Foreign Rash Erythematous Health 24-Jun-2005 12:19 PM Page: 1287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5 MG DAY Date:02/05/01ISR Number: 3663103-5Report Type:Expedited (15-DaCompany Report #GBS000505952 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Other Headache Health Modecate Pulmonary Embolism Professional (Fluphenazine Other Decanoate) C Benztropine C Date:02/06/01ISR Number: 3661032-4Report Type:Expedited (15-DaCompany Report #US_010158682 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thrombin Decreased Consumer Zyprexa PS 5 MG/DAY Impaired Healing Prozac (Fluoxetine Laboratory Test Abnormal Hydrochloride) SS Platelet Count Decreased Paxil (Paroxetine Sedation Hydrochloride) C Weight Increased Xanax (Alprazolam) C Date:02/06/01ISR Number: 3661037-3Report Type:Expedited (15-DaCompany Report #US_010158601 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Bipolar Disorder Other Lamictal Condition Aggravated (Lamotrigine) C Lithium C Amlodipine C ORAL Date:02/06/01ISR Number: 3661053-1Report Type:Expedited (15-DaCompany Report #US_010158657 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Professional Claritin Company (Loratadine) C Representative Date:02/06/01ISR Number: 3661201-3Report Type:Expedited (15-DaCompany Report #US_010158306 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS Eli Lilly And Co 25 MG/DAY Initial or Prolonged Hallucination Professional Medication Error Psychotic Disorder 24-Jun-2005 12:19 PM Page: 1288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/01ISR Number: 3661209-8Report Type:Expedited (15-DaCompany Report #US_010158498 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co 5 MG Professional Tegretol Company (Carbamazepine) C Representative Date:02/06/01ISR Number: 3661211-6Report Type:Expedited (15-DaCompany Report #US_010158510 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 IN Drug Toxicity Professional THE EVENING Suicidal Ideation Company Trazodone C Representative Celexa (Citalopram Hydrobromide) C Synthroid (Levothyroxine Sodium) C Date:02/06/01ISR Number: 3661215-3Report Type:Expedited (15-DaCompany Report #US_010158537 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Professional Effexor (Venlafaxine Company Hydrochloride) C Representative Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Neurontin (Gabapentin) C Ativan (Lorazepam) C Naproxen C Zocor (Simvastatin) C Accupril (Quinapril Hydrochloride) C Tagamet (Cimetidine) C Amitriptyline C Date:02/06/01ISR Number: 3662611-0Report Type:Expedited (15-DaCompany Report #GBS010108137 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY 6 WK Lower Respiratory Tract Health Modecate Infection Professional (Fluphenazine Company Decanoate) C Representative Chlorpromazine C Other 24-Jun-2005 12:19 PM Page: 1289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/01ISR Number: 3662624-9Report Type:Expedited (15-DaCompany Report #EWC001008245 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Haemorrhage Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Thrombocytopenia Health Forlax (Macrogol) C Professional Other Date:02/06/01ISR Number: 3662627-4Report Type:Expedited (15-DaCompany Report #CA_010103064 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Affective Disorder Foreign Zyprexa PS Eli Lilly And Co 800 MG Alcoholism Health Completed Suicide Professional Delusional Disorder, Company Mixed Type Representative Depression Other Overdose Paranoia Date:02/06/01ISR Number: 3662631-6Report Type:Expedited (15-DaCompany Report #GBS010108133 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Hospitalization - Blood Pressure Increased Consumer Procyclidine C Initial or Prolonged Cardiomegaly Health Atenolol C Confusional State Professional Zopiclone C Coronary Artery Disease Other Haloperidol C Ecchymosis Heart Rate Increased Hepatic Congestion Hepatic Steatosis Lung Consolidation Malaise Metabolic Acidosis Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Pulmonary Congestion Pulmonary Oedema Pyrexia Skin Ulcer Vomiting Date:02/06/01ISR Number: 3662696-1Report Type:Expedited (15-DaCompany Report #EWC010125206 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Pancreatic Cyst Health Lorazepam C Procedural Site Reaction Professional Benzotropine Other (Benzatropine Mesilate) C Zuclopenthixol C 24-Jun-2005 12:19 PM Page: 1290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/01ISR Number: 3662699-7Report Type:Expedited (15-DaCompany Report #EWC010125207 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertrophy Foreign Zyprexa PS Eli Lilly And Co 7.5 MG DAY Initial or Prolonged Hypothalamo-Pituitary Health Disorders Professional Other Date:02/06/01ISR Number: 3662702-4Report Type:Expedited (15-DaCompany Report #EWC010125222 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Retinal Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Other Date:02/06/01ISR Number: 3662706-1Report Type:Expedited (15-DaCompany Report #EWC010125227 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Completed Suicide Health Hallucination Professional Company Representative Other Date:02/06/01ISR Number: 3662744-9Report Type:Expedited (15-DaCompany Report #GBS010108130 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Foreign Zyprexa PS Eli Lilly And Co 5 MG/IN THE Haemorrhagic Stroke Health EVENING Hypertension Professional Lithium Carbonate C Oedema Peripheral Other Venlafaxine C Date:02/06/01ISR Number: 3662748-6Report Type:Expedited (15-DaCompany Report #EWC010125031 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS Eli Lilly And Co 22.5 MG DAY Hospitalization - Pyrexia Health Rivotril Initial or Prolonged Toxic Epidermal Professional (Clonazepam) C Necrolysis Other Tegretol (Carbamazepine) C Date:02/06/01ISR Number: 3662910-2Report Type:Expedited (15-DaCompany Report #AU_010102940 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co Health Carbamazepine C Professional Vigabatrin C Other 24-Jun-2005 12:19 PM Page: 1291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/01ISR Number: 3662911-4Report Type:Expedited (15-DaCompany Report #CA_000901929 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co 10 MG AT Breech Presentation Consumer BEDTIME Caesarean Section Other Materna C Cervical Incompetence Polifer C Complications Of Maternal Iron C Exposure To Therapeutic Folic Acid C Drugs Premature Baby Date:02/06/01ISR Number: 3662912-6Report Type:Expedited (15-DaCompany Report #CA_010103092 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Neonatal Foreign Zyprexa PS Eli Lilly And Co Complications Of Maternal Consumer Materna C Exposure To Therapeutic Other Drugs Premature Baby Date:02/06/01ISR Number: 3662915-1Report Type:Expedited (15-DaCompany Report #EWC010125245 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co Health Nozinan Professional (Levomepromazine) C Company Representative Other Date:02/06/01ISR Number: 3662916-3Report Type:Expedited (15-DaCompany Report #EWC010125253 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Foreign Zyprexa PS Eli Lilly And Co 25 MG DAY Rectal Haemorrhage Health Cogentin Professional (Benzatropine Other Mesilate) C Date:02/12/01ISR Number: 3663846-3Report Type:Direct Company Report # Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Olanzapine PS ORAL 5 MG PO AM; Syndrome 15 MG PO HS Ayerqestin C Premarin C Sinemet C Neurontin C Oxycontin C Ocal C 24-Jun-2005 12:19 PM Page: 1292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/01ISR Number: 3664104-3Report Type:Periodic Company Report #HQ0768708SEP2000 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Effexor PS Wyeth Ayerst Initial or Prolonged Professional Laboratories ORAL ORAL Other Quetiapine (Quetiapine) SS ORAL ORAL Pyrexa (Olanzapine) SS ORAL ORAL Date:02/12/01ISR Number: 3664242-5Report Type:Expedited (15-DaCompany Report #01-01-0030 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 60 MG QD ORAL Respiratory Disorder Professional Olanzapine Tablets SS ORAL 30MG QD ORAL White Blood Cell Count Lorazepam 2 Mg Tid C Decreased Date:02/13/01ISR Number: 3664801-XReport Type:Expedited (15-DaCompany Report #US_001153629 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS Eli Lilly And Co 25 MG/ DAY 8 DAY Initial or Prolonged Confusional State Professional Prevacid(Lansoprazol Other Diverticulitis e) C Gastritis Oscal(Calcium Gastrointestinal Carbonate) C Haemorrhage Multivitamins Haematochezia Nos(Multivitamins Hallucination Nos) C International Normalised Ratio Decreased Lethargy Platelet Count Decreased Sedation Date:02/13/01ISR Number: 3665056-2Report Type:Expedited (15-DaCompany Report #AU_010102950 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Professional Other Date:02/13/01ISR Number: 3665058-6Report Type:Expedited (15-DaCompany Report #EWC010125298 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa PS Eli Lilly And Co 30 MG/DAY Hospitalization - Arrhythmia Health Initial or Prolonged Electrocardiogram Qt Professional Corrected Interval Other Prolonged Overdose Sudden Death 24-Jun-2005 12:19 PM Page: 1293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/01ISR Number: 3665070-7Report Type:Expedited (15-DaCompany Report #EWC010125305 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Haemorrhage Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Hospitalization - Other Risperdal Initial or Prolonged (Risperidone) C Seroxat (Paroxetome Hydrochloride) C Date:02/13/01ISR Number: 3665073-2Report Type:Expedited (15-DaCompany Report #EWC010225406 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Purpura Health Professional Other Date:02/13/01ISR Number: 3665077-XReport Type:Expedited (15-DaCompany Report #EWC010225382 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Professional Other Date:02/13/01ISR Number: 3665086-0Report Type:Expedited (15-DaCompany Report #EWC010225389 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Decreased Health Professional Other Date:02/13/01ISR Number: 3665088-4Report Type:Expedited (15-DaCompany Report #EWC010225399 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Lithium Carbonate C Professional Flurazepam C Other Artrane (Trihexyphenidyl Hydrochloride) C Date:02/13/01ISR Number: 3665094-XReport Type:Expedited (15-DaCompany Report #GBS010108165 Age: Gender: I/FU:I Outcome PT Death Abortion Spontaneous Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs Congenital Anomaly 24-Jun-2005 12:19 PM Page: 1294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Foetal Disorder Pregnancy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co Health Professional Other Date:02/13/01ISR Number: 3665099-9Report Type:Expedited (15-DaCompany Report #EWC010125336 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Leukopenia Health Depamide Pyrexia Professional (Valpromide) C Other Gardenal (Phenobarbital) C Urbanyl (Clobazam) C Date:02/13/01ISR Number: 3665103-8Report Type:Expedited (15-DaCompany Report #EWC010125342 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Increased Health Buspirone Aspartate Professional Hydrochloride C Aminotransferase Company Mianserin C Increased Representative Blood Lactate Other Dehydrogenase Increased Eosinophilia Gamma-Glutamyltransferase Increased Leukopenia Date:02/13/01ISR Number: 3665107-5Report Type:Expedited (15-DaCompany Report #GBS010108152 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Function Abnormal Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY 39 DAY Hospitalization - Pneumonia Health Initial or Prolonged Professional Company Representative Other Date:02/13/01ISR Number: 3665110-5Report Type:Expedited (15-DaCompany Report #US_010259029 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Foreign Olanzapine PS 10 MG/1 DAY Leukopenia Literature Neutropenia Health Pneumonia Professional Pyrexia Other 24-Jun-2005 12:19 PM Page: 1295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/01ISR Number: 3665134-8Report Type:Expedited (15-DaCompany Report #EWC010125319 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Prozac (Fluoxetine Mycosis Fungoides Health Hydrochloride) PS 40 MG/DAY Professional Zyprexa (Olanzapine) SS 7.5 MG/DAY Other Anafranil (Clomipramine Hydrochloride) C Date:02/13/01ISR Number: 3665292-5Report Type:Expedited (15-DaCompany Report #US_010158591 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Iron Decreased Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY Productive Cough Prozac (Fluoxetine Hydrochloride) SS 20 MG/DAY 6 YR Mellaril (Thioridazine Hydrochloride) C Divalproex Sodium C Date:02/13/01ISR Number: 3665294-9Report Type:Expedited (15-DaCompany Report #US_010158851 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa PS Eli Lilly And Co 10 MG DAY Sedation Professional Depakote (Valproate Company Semisodium) C Representative Lithium C Date:02/13/01ISR Number: 3665295-0Report Type:Expedited (15-DaCompany Report #US_010158520 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co 20 MG Professional Non Steroidal Company Antiinflammatory Representative (Otc) C Date:02/13/01ISR Number: 3665297-4Report Type:Expedited (15-DaCompany Report #US_010158524 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zyprexa PS Eli Lilly And Co 30 MG Lethargy Professional Klonopin Sedation Company (Clonazepam) C Representative Depakote (Valproate Semisodium) C Date:02/13/01ISR Number: 3665298-6Report Type:Expedited (15-DaCompany Report #US_010158794 Age: Gender:Female I/FU:I Outcome PT Report Source Other Abnormal Behaviour Health Pancreatitis Professional 24-Jun-2005 12:19 PM Page: 1296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Depakote (Valproate Semisodium) C Date:02/13/01ISR Number: 3665299-8Report Type:Expedited (15-DaCompany Report #US_010159008 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Hallucination Professional Ranitidine C Hypovolaemic Shock Pancreatitis Acute Date:02/13/01ISR Number: 3665430-4Report Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diplopia Gabapentin PS Eye Pain Olanzapine SS Date:02/13/01ISR Number: 3666427-0Report Type:Expedited (15-DaCompany Report #EWC001008274 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Macrocytic Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Health Professional Other Date:02/13/01ISR Number: 3666428-2Report Type:Expedited (15-DaCompany Report #EWC001108585 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Foreign Zyprexa (Olanzapine) PS 25 MG/DAY Hyperglycaemia Health Teralithe (Lithium Hypertriglyceridaemia Professional Carbonate) C Weight Increased Other Stablon (Tianeptine) C Largactil (Chlorpromazine Hydrochloride) C Date:02/13/01ISR Number: 3666429-4Report Type:Expedited (15-DaCompany Report #US_001255014 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Olanzapine PS 10 MG/1 DAY Initial or Prolonged Pleural Effusion Health Paroxetine C Pneumonia Professional Pyrexia Other 24-Jun-2005 12:19 PM Page: 1297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/01ISR Number: 3664700-3Report Type:Direct Company Report # Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Zyprexa (5 Mg) PS ORAL 5MG PO QID Hypotension Albuterol SS ORAL 0.5ML NEB Q 4 HRS Prozac C Depakote C Neurontin C Clonidine C Ddavp C Zithromax C Tylenol C Motrin C Racemic Epi C Date:02/15/01ISR Number: 3665608-XReport Type:Expedited (15-DaCompany Report #B0098251A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Becotide PS Glaxo Wellcome RESPIRATORY Health (INHALATION) Professional Ventoline SS Glaxo Wellcome RESPIRATORY (INHALATION) Olanzapine SS ORAL Date:02/16/01ISR Number: 3666119-8Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa PS ORAL 20MG ORAL Sinequan C Date:02/20/01ISR Number: 3666731-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Haldol PS ORAL 5MG PO BID Initial or Prolonged Syndrome Olanzapine SS Required Cogentin C Intervention to Ativan C Prevent Permanent Impairment/Damage Date:02/20/01ISR Number: 3666796-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olanzapine PS 10 MG QD / Hospitalization - Syndrome VARIOUS DOSES Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 1298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/01ISR Number: 3667212-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zydis / 5 Mg PS Zyprexa Zydis 5mg SS Date:02/20/01ISR Number: 3667214-XReport Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa / 10 Mg PS ORAL 10MG QD ORAL Orthostatic Hypotension Syncope Date:02/21/01ISR Number: 3667829-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa (Olanzapine) PS Lilly Zyrtec(Cetirizine Hydrochloride) SS Pfizer Date:02/21/01ISR Number: 3668063-9Report Type:Expedited (15-DaCompany Report #US_010259458 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Gastrointestinal Professional BEDTIME A FEW Haemorrhage MONTHS Haematochezia Prozac (Fluoxetine Hydrochloride) SS 20 MG/DAY A FEW MONTHS Lithium C Trazodone C Atenolol C K-Dur (Potassium Chloride) C Synthroid (Levothyroxine Sodium) C Date:02/21/01ISR Number: 3668071-8Report Type:Expedited (15-DaCompany Report #US_010259777 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Decreased Professional Clozapine C Company Representative Date:02/21/01ISR Number: 3668072-XReport Type:Expedited (15-DaCompany Report #US_010259189 Age:88 YR Gender:Female I/FU:I Outcome PT Other Electrocardiogram Qt Corrected Interval 24-Jun-2005 12:19 PM Page: 1299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co 7.5 MG/DAY 21 MON Professional Accupril (Quinapril Hydrochloride) C Trazodone C Sorbitol C Vitamin D C Zoloft (Sertraline Hydrochloride) C Miacalcin (Calcitonin, Salmon) C Nitro-Dur (Glyceryl Trinitrate) C Plavix (Clopidogrel Sulfate) C Marional (Dronabinol) C ORAL Date:02/21/01ISR Number: 3668074-3Report Type:Expedited (15-DaCompany Report #US_010259319 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa PS Eli Lilly And Co 2 WK Hospitalization - Depressed Level Of Professional Lithium C Initial or Prolonged Consciousness Company Carbamazepine C Other Pollakiuria Representative Pulmonary Embolism Date:02/21/01ISR Number: 3668076-7Report Type:Expedited (15-DaCompany Report #US_010259521 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Initial or Prolonged Condition Aggravated Professional Date:02/21/01ISR Number: 3668078-0Report Type:Expedited (15-DaCompany Report #US_010259567 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Embolus Health Zyprexa PS Eli Lilly And Co 25 MG/DAY Other Chest Pain Professional Glyburide C Deep Vein Thrombosis Metformin C Drug Level Above Therapeutic Pulmonary Embolism Date:02/21/01ISR Number: 3668079-2Report Type:Expedited (15-DaCompany Report #US_010259441 Age:17 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Amnesia Difficulty In Walking Disorientation Dysarthria 24-Jun-2005 12:19 PM Page: 1300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucinations, Mixed Heart Rate Increased Overdose Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Consumer Fluoxetine Hcl PS Lilly Research Syncope Laboratories Div Eli Tic Lilly And Co 20 MG/DAY 2 MON Zyprexa (Olanzapine) SS 100 MG/DAY Date:02/21/01ISR Number: 3668965-3Report Type:Periodic Company Report #JRFUSA2000007073 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Neuroleptic Malignant Professional Olanzapine Required Syndrome (Olanzapine) SS ORAL 10 MG, 1 IN 1 Intervention to NIGHT(S), Prevent Permanent ORAL Impairment/Damage Lithium (Lithium) C Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:02/21/01ISR Number: 3669173-2Report Type:Expedited (15-DaCompany Report #US_001152797 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Drug Ineffective Health Zyprexa (Olanzapine) SS 20 MG DAY Hepatic Neoplasm Professional Malignant Jaundice Psychotic Disorder Date:02/21/01ISR Number: 3669391-3Report Type:Expedited (15-DaCompany Report #EWC010225372 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Hospitalization - Hyperprolactinaemia Health Xanax C Initial or Prolonged Myocardial Infarction Professional Weight Increased Company Representative Date:02/21/01ISR Number: 3669393-7Report Type:Expedited (15-DaCompany Report #EWC010225438 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Blood Pressure Decreased Health Tercian(Cyamemazine) C Pulmonary Embolism Professional Heptaminol C Pyrexia Company Diane-35 C Representative 24-Jun-2005 12:19 PM Page: 1301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669395-0Report Type:Expedited (15-DaCompany Report #AU_010102939 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Neutropenia Health Carbamazepine C Pyrexia Professional Vigabatrin C Date:02/21/01ISR Number: 3669397-4Report Type:Expedited (15-DaCompany Report #EWC010225414 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Initial or Prolonged Parkinson'S Disease Health Madopar C Rhabdomyolysis Professional Other Date:02/21/01ISR Number: 3669656-5Report Type:Periodic Company Report #JRFUSA1999004363 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Confusional State Professional Olanzapine Required Extrapyramidal Disorder (Olanzapine) SS Intervention to Bupropion Prevent Permanent (Amfebutamone) C Impairment/Damage Depakote (Valproate Semisodium) C Prednisone (Prednisone) C Date:02/22/01ISR Number: 3669053-2Report Type:Expedited (15-DaCompany Report #EWC001209401 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Increased Health Haloperidol C Gamma-Glutamyltransferase Professional Increased Company Leukocytosis Representative Weight Increased Other Date:02/22/01ISR Number: 3669344-5Report Type:Expedited (15-DaCompany Report #CA_000901929 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co 10 MG AT Breech Presentation Consumer BEDTIME Caesarean Section Other Materna C Cervical Incompetence Polifer C Complications Of Maternal Iron C Exposure To Therapeutic Folic Acid C Drugs Pregnancy Premature Baby 24-Jun-2005 12:19 PM Page: 1302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/01ISR Number: 3669345-7Report Type:Expedited (15-DaCompany Report #EWC001008419 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Professional Other Date:02/22/01ISR Number: 3669347-0Report Type:Expedited (15-DaCompany Report #GBS001106994 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/IN THE Hospitalization - Decreased Activity Health EVENING Initial or Prolonged Extrasystoles Professional Aspirin C Disability Fall Other Lansoprazole C Femur Fracture Haloperidol C Orthostatic Hypotension Date:02/22/01ISR Number: 3669348-2Report Type:Expedited (15-DaCompany Report #EWC010125336 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Leukopenia Health Depamide Pyrexia Professional (Valpromide) C Other Gardenal (Phenobarbital) C Date:02/22/01ISR Number: 3669350-0Report Type:Expedited (15-DaCompany Report #DE_010104813 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Zyprexa PS Eli Lilly And Co 5 MG/2DAY Initial or Prolonged Health Professional Other Date:02/22/01ISR Number: 3669351-2Report Type:Expedited (15-DaCompany Report #EWC010225382 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Professional Other Date:02/22/01ISR Number: 3669353-6Report Type:Expedited (15-DaCompany Report #AU_010102923 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Zyprexa PS Eli Lilly And Co 30 MG/DAY Initial or Prolonged Health Epilim (Valproate Professional Sodium) C Other 24-Jun-2005 12:19 PM Page: 1303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/01ISR Number: 3669355-XReport Type:Expedited (15-DaCompany Report #EWC010125128 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Abnormal Pertofran (Desipramine Hydrochloride) C Date:02/22/01ISR Number: 3669461-XReport Type:Expedited (15-DaCompany Report #CA_010103092 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Neonatal Foreign Zyprexa PS Eli Lilly And Co Breech Delivery Consumer Materna C Complications Of Maternal Other Polifer C Exposure To Therapeutic Iron C Drugs Folic Acid C Premature Baby Small For Dates Baby Date:02/22/01ISR Number: 3669470-0Report Type:Expedited (15-DaCompany Report #EWC001208977 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged White Blood Cell Count Health Previscan Decreased Professional (Fluindione) C Other Fer "Ucb" (Ferrous Chloride) C Innohep (Heparin-Fraction, Sodium Salt) C Date:02/22/01ISR Number: 3669634-6Report Type:Expedited (15-DaCompany Report #US_010158510 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Zyprexa PS Eli Lilly And Co 2.5 MG/1 IN Suicidal Ideation Professional THE EVENING Company Trazodone C Representative Celexa C Synthroid C Date:02/22/01ISR Number: 3669635-8Report Type:Expedited (15-DaCompany Report #US_010157546 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Hallucination Professional Aricept C Insomnia Lanoxin C Oral Intake Reduced Norvasc C Psychotic Disorder Avalide C Thinking Abnormal Catapressan C 24-Jun-2005 12:19 PM Page: 1304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/01ISR Number: 3669636-XReport Type:Expedited (15-DaCompany Report #US_000643502 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Other Mitral Valve Disease Professional Delatestryl C Sudden Death Vitamin C C Vitamin B Complex C Calcium Carbonate C Acetaminophen C Multivitamin C Date:02/22/01ISR Number: 3669637-1Report Type:Expedited (15-DaCompany Report #US_010157728 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Zyprexa PS Eli Lilly And Co 6 MG/1 IN THE Initial or Prolonged Back Pain Health EVENING Blood Potassium Decreased Professional Fluoxetine Electrocardiogram (Fluoxetine Abnormal Hydrochloride) SS 50 MG/1 IN Flat Affect THE EVENING Subarachnoid Haemorrhage Ziac C Ventricular Extrasystoles Progesterone C White Blood Cell Count Premarin C Increased Flovent C Alupent C Ativan C Date:02/22/01ISR Number: 3669638-3Report Type:Expedited (15-DaCompany Report #US_000846890 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG/AT Initial or Prolonged Condition Aggravated Health BEDTIME Dizziness Professional Pepcid C Fatigue Amaryl C Gastritis Atenolol C Gastrointestinal Cordarone C Angiodysplasia Furosemide C Gastrointestinal Evista C Haemorrhage Synthroid C Lethargy Prinivil C Rectal Haemorrhage K-Dur C Sedation Calcium With Vitamin D C Vitamin E C Aspirin C Xalatan C Date:02/22/01ISR Number: 3669639-5Report Type:Expedited (15-DaCompany Report #US_010158537 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co 30 MG DAY Professional Effexor (Venlafaxine Company Hydrochloride) C Representative Haldol (Haloperidol) C Cogentin 24-Jun-2005 12:19 PM Page: 1305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) C Neurontin (Gabapentin) C Ativan (Lorazepam) C Naproxen C Zocor (Simvastatin) C Accupril (Quinapril Hydrochloride) C Tagamet (Cimetidine) C Amitriptyline C Glyburide C Diabetes C Date:02/22/01ISR Number: 3669640-1Report Type:Expedited (15-DaCompany Report #US_010158524 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zyprexa PS Eli Lilly And Co 30 MG Diabetic Ketoacidosis Professional Klonopin Lethargy (Clonazepam) C Sedation Depakote (Valproate Semisodium) C Date:02/22/01ISR Number: 3669641-3Report Type:Expedited (15-DaCompany Report #US_010158520 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co 20 MG Professional Prozac (Fluoxetine Company Hydrochloride) SS 60 MG DAY Representative Non Steroidal Antiinflammatory (Otc) C Remeron(Mirtazapine) C Klonopin (Clonazepam) C Trazodone C Date:02/23/01ISR Number: 3669906-5Report Type:Expedited (15-DaCompany Report #CA_010103092 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Breech Presentation Consumer Materna 1.60 C Complications Of Maternal Other Polifer C Exposure To Therapeutic Iron C Drugs Folic Acid C Neonatal Disorder Pregnancy Premature Baby Small For Dates Baby 24-Jun-2005 12:19 PM Page: 1306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/01ISR Number: 3670565-6Report Type:Expedited (15-DaCompany Report #US_010259832 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co Corrected Interval Professional Thorazine Prolonged (Chlorpromazine Hydrochloride) C .. C Date:02/26/01ISR Number: 3670593-0Report Type:Expedited (15-DaCompany Report #US_010259783 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Professional Zyprexa (Olanzapine) SS 20 MG/1 DAY Company Depakote (Valproate Representative Semisodium) C Ativan (Lorazepam) C Neurontin (Gabapentin) C Date:02/26/01ISR Number: 3670595-4Report Type:Expedited (15-DaCompany Report #US_010260122 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Zyprexa PS Eli Lilly And Co 150 MG/DAY Initial or Prolonged Depressed Level Of Professional Consciousness Hypersomnia Respiratory Depression Sedation Date:02/26/01ISR Number: 3670596-6Report Type:Expedited (15-DaCompany Report #US_010259675 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombosis Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:02/26/01ISR Number: 3670612-1Report Type:Expedited (15-DaCompany Report #US_010157965 Age:45 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Aspartate Aminotransferase Increased Blood Cholesterol Decreased Blood Triglycerides Increased Haemoglobin Decreased Hypophosphataemia Mean Cell Volume Abnormal Mean Cell Volume 24-Jun-2005 12:19 PM Page: 1307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Monocyte Count Increased Neutrophil Count Increased Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Study Zyprexa PS Eli Lilly And Co 3 DSG Increased Health FORM/DAY Professional Neosporin Ointment C Chloral Hydrate C Tylenol (Paracetamol) C Date:02/26/01ISR Number: 3670613-3Report Type:Expedited (15-DaCompany Report #US_010157728 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Study Zyprexa PS Eli Lilly And Co 6 MG/1 IN THE Initial or Prolonged Blood Potassium Decreased Health EVENING Dizziness Professional Fluoxetine Hyperhidrosis (Fluoxetine Subarachnoid Haemorrhage Hydrochloride) SS 50 MG/1 IN Ventricular Extrasystoles THE EVENING White Blood Cell Count Ziac C Increased Progesterone C Premarin (Estrogens Conjugated) C Flovent (Fluticasone Propionate) C Alupent (Orciprenaline Sulfate) C Ativan (Lorazepam) C Date:02/26/01ISR Number: 3671200-3Report Type:Expedited (15-DaCompany Report #EWC010225505 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Haemothorax Health Diazepam C Head Injury Professional Hepatic Rupture Other Injury Kidney Rupture Lower Limb Fracture Peritoneal Haemorrhage Skull Fracture Date:02/26/01ISR Number: 3671201-5Report Type:Expedited (15-DaCompany Report #EWC010225531 Age:2 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Exposure To Therapeutic Health Citalopram C Drugs Professional Cyanosis Neonatal Company Oedema Peripheral Representative Ventricular Septal Defect 24-Jun-2005 12:19 PM Page: 1308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/01ISR Number: 3671202-7Report Type:Expedited (15-DaCompany Report #EWC010225530 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Zyprexa PS Eli Lilly And Co Consumer Ventoline C Date:02/26/01ISR Number: 3671376-8Report Type:Expedited (15-DaCompany Report #GBS980500610 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Hypotension Health Aspirin C Laceration Professional Chlormethiazole C Sinus Bradycardia Other Promazine C Lorazepam C Diazepam C Date:02/26/01ISR Number: 3671377-XReport Type:Expedited (15-DaCompany Report #GBS980400389 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Hypotension Health Promazine C Laceration Professional Lorazepam C Sinus Bradycardia Company Aspirin C Representative Chlormethiazole C Other Diazepam C Date:02/26/01ISR Number: 3671378-1Report Type:Expedited (15-DaCompany Report #EWC010125298 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Hospitalization - Diarrhoea Depakine Chrono C Initial or Prolonged Electrocardiogram Qt Etumine (Clotiapine) C Corrected Interval Oxazepam C Prolonged Mogadon (Nitrazepam) C Heart Rate Increased Xanax (Alprazolam) C Myocardial Infarction Medrol Sudden Death (Methylprednisolone) C Ventricular Fibrillation Prothiaden (Dosulepin) C Barexal C Date:02/26/01ISR Number: 3671379-3Report Type:Expedited (15-DaCompany Report #GBS010108152 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY 39 DAY Hospitalization - Bronchopneumonia Health Depixol (Flupentixol Initial or Prolonged Liver Function Test Professional Decanoate) C Abnormal Company Lower Respiratory Tract Representative Infection Other Tremor Viral Upper Respiratory Tract Infection 24-Jun-2005 12:19 PM Page: 1309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3671512-3Report Type:Periodic Company Report #US_001153386 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Olanzapine PS Eli Lilly And Initial or Prolonged Professional Company 12 MG/1 DAY Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 DAY Date:02/27/01ISR Number: 3671513-5Report Type:Periodic Company Report #US_001153198 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Health Olanzapine PS Eli Lilly And Initial or Prolonged Professional Company 18MG/1 IN THE EVENING Fluoxetine (Fluoxetine Hydrochloride) SS 50MG/1 IN THE EVENING Date:02/27/01ISR Number: 3671518-4Report Type:Periodic Company Report #US_001152834 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Olanzapine PS Eli Lilly And Initial or Prolonged Professional Company 6 MG/1 DAY Fluoxetine Hydrochloride SS 50MG/1 DAY Premarin (Estrogens Conjugated C Singulair (Montelukast Sodium) C Serevent Inhaler C Proventil Inhaler (Salbutamol) C Metamucil (Psyllium Hydrophilic Mucilloid) C Zestril (Lisinopril) C Baycol (Cerivastatin Sodium) C Date:02/27/01ISR Number: 3671519-6Report Type:Periodic Company Report #US_001052448 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Health Fluoxetine Initial or Prolonged Professional (Fluoxetine Hydrochloride) PS 25 MG / 1 DAY Olanzapine SS Eli Lilly And Company 12 MG/1 DAY Nitro Patch (Glyceryl Trinitrate) C Zocor (Simvastatin C Folic Acid C 24-Jun-2005 12:19 PM Page: 1310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3671522-6Report Type:Periodic Company Report #US_001052128 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Fluoxetine Initial or Prolonged Depression Professional Hydrochloride PS 25 MG/ 1 IN THE EVENING Olanzapine SS Eli Lilly And Company 12 MG/ 1 IN THE EVENING Serax(Oxazepam) C Multivitamin C Date:02/27/01ISR Number: 3671541-XReport Type:Periodic Company Report #US_000950643 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Literature Olanzapine PS Eli Lilly And Initial or Prolonged Depression Health Company 10 MG/1 DAY Drug Dependence Professional Fluoxetine Drug Interaction (Fluoxetine Hydrochloride) SS 40 MG/1 DAY Buspirone C Trazodone C Zolpidem C Mirtazapine C Levothyroxine C Date:02/27/01ISR Number: 3671579-2Report Type:Periodic Company Report #US_000949694 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Consumer Zyprexa (Olanzapine) PS Eli Lilly And Initial or Prolonged Dysphagia Company Disability Extrapyramidal Disorder Prozac (Fluoxetine Other Hallucination Hydrochloride) SS 18 MON Hypertonia Depakote (Valproate Hypotension Semisodium) C Movement Disorder Quetiapine C Musculoskeletal Stiffness Trilafon C Personality Disorder Aricept (Donepezil Pneumonia Aspiration Hydrochloride) C Respiratory Disorder Skin Ulcer Date:02/27/01ISR Number: 3671581-0Report Type:Periodic Company Report #US_000949660 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Study Olanzapine PS Eli Lilly And Health Company 6 MG/1 AT Professional BEDTIME Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 AT BEDTIME 24-Jun-2005 12:19 PM Page: 1311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3671596-2Report Type:Periodic Company Report #US_000948692 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa(Olanzapine) PS Eli Lilly And Congestive Professional Company 15 MG/DAY Libido Decreased Prozac (Fluoxetine Hydrochloride) SS 20 MG/DAY Valium (Diazepam) C Lamictal(Lamotrigine ) C Ziac C Date:02/27/01ISR Number: 3671607-4Report Type:Periodic Company Report #US_000848421 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Initial or Prolonged Health (Fluoxetine Professional Hydrochloride) PS 5 MG/1 AT BEDTIME Olanzapine SS Eli Lilly And Company 6 MG/1 AT BEDTIME Ativan (Lorazepam) C Date:02/27/01ISR Number: 3673533-3Report Type:Periodic Company Report #US_000846584 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Prozac PS Lilly Research Initial or Prolonged Suicide Attempt Health Laboratories Div Eli Professional Lilly And Co 50 MG/1 IN THE EVENING Olanzapine SS 6 MG/1 IN THE EVENING Date:02/27/01ISR Number: 3673535-7Report Type:Periodic Company Report #US_000846457 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cystitis Consumer Prozac PS Lilly Research Deafness Laboratories Div Eli Faecal Incontinence Lilly And Co 20 MG/DAY 7 YR Tremor Zyprexa (Olanzapine) SS 10 MG/DAY Weight Increased Nortriptyline C Date:02/27/01ISR Number: 3673539-4Report Type:Periodic Company Report #US_000746126 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 75MG Olanzapine SS 18 MG 24-Jun-2005 12:19 PM Page: 1312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3673541-2Report Type:Periodic Company Report #US_000746109 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Study Fluoxetine Hcl PS Lilly Research Health Laboratories Div Eli Professional Lilly And Co 50 MG/ 1 DAY Olanzapine SS 6 MG/1 DAY Multiple Vitamins C Date:02/27/01ISR Number: 3673543-6Report Type:Periodic Company Report #US_000746066 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Suicide Attempt Health Laboratories Div Eli Professional Lilly And Co 25 MG/ 1 DAY Olanzapine SS 6 MG/1 DAY Date:02/27/01ISR Number: 3673545-XReport Type:Periodic Company Report #US_000745588 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 50 MG AT BEDTIME Olanzapine SS 6 MG AT BEDTIME Aspirin C Date:02/27/01ISR Number: 3673546-1Report Type:Periodic Company Report #US_000745254 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 50 MG IN THE EVENING Olanzapine SS 6 MG IN THE EVENING Date:02/27/01ISR Number: 3673548-5Report Type:Periodic Company Report #US_000744968 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 50 MG / 1 DAY Olanzapine SS 6 MG/ 1 DAY Ibuprofen C Multivitamin C Vitamin E C Vitamin C C 24-Jun-2005 12:19 PM Page: 1313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3673553-9Report Type:Periodic Company Report #US_000643950 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Intolerance Health Fluoxetine Hcl PS Eli Lilly And Initial or Prolonged Professional Company Olanzapine SS Naprosyn(Naproxen) C Date:02/27/01ISR Number: 3673564-3Report Type:Periodic Company Report #US_000643670 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 75 MG/1 AT BEDTIME Olanzapine SS 12 MG/1 AT BEDTIME Valium (Diazepam) C Date:02/27/01ISR Number: 3673578-3Report Type:Periodic Company Report #US_000643431 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neck Pain Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 3 DSG FORM DAY Olanzapine SS 3 DSG FORM DAY Imitrex C Ativan C Rolaids C Zantac C Tylenol C Aspirin C Contact C Comtrex C Laxative C Anexsia C Relafen C Date:02/27/01ISR Number: 3673584-9Report Type:Periodic Company Report #US_000642931 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co Olanzapine SS Date:02/27/01ISR Number: 3673588-6Report Type:Periodic Company Report #US_000542173 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Depression Study Initial or Prolonged Neurosis Health 24-Jun-2005 12:19 PM Page: 1314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Fluoxetine Hcl PS Lilly Research Laboratories Div Eli Lilly And Co 2 DSG FORM/1 IN THE EVENING Olanzapine SS 1 DSG FORM/1 IN THE MORNING Premarin C Pepcid C Centrum C Tums C Date:02/27/01ISR Number: 3673601-6Report Type:Periodic Company Report #US_000541050 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 60 MG/1 IN THE MORNING Olanzapine SS 25 MG/1 AT BEDTIME Prevacid (Lansoprazole) C Loestrin C Naprosyn (Naproxen) C Tylenol (Paracetamol) C Date:02/27/01ISR Number: 3673603-XReport Type:Periodic Company Report #US_000541044 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Prozac PS Lilly Research Initial or Prolonged Lactic Acidosis Professional Laboratories Div Eli Nausea Lilly And Co Vomiting Zyprexa (Olanzapine) SS Date:02/27/01ISR Number: 3673607-7Report Type:Periodic Company Report #US_000540903 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paraesthesia Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 25 MG/1 DAY Olanzapine SS 6 MG/1 DAY Premphase C Zestoretic C Allegra (Fexofenadine Hydrochloride) C Allergy Shot C Tagamet (Cimetidine) C Ibuprofen C 24-Jun-2005 12:19 PM Page: 1315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prilosec (Omeprazole) C Hydrochlorothiazide C Fiber C Date:02/27/01ISR Number: 3673609-0Report Type:Periodic Company Report #US_000540893 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Consumer Prozac PS Lilly Research Initial or Prolonged Intentional Misuse Health Laboratories Div Eli Menometrorrhagia Professional Lilly And Co 20 MG/DAY Weight Decreased Zyprexa (Olanzapine) SS 15 MG/DAY 1 MON Weight Increased Date:02/27/01ISR Number: 3673627-2Report Type:Periodic Company Report #US_000439094 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Fluoxetine Initial or Prolonged Health (Fluoxetine Professional Hydrochloride) PS Lilly Research Laboratories Div Eli Lilly And Co 50 MG Olanzapine SS 12 MG Ativan (Lorazepam) C Lo/Ovral C Multivitamin C Calcium C Tylenol (Paracetamol) C Ferrous Sulfate C Nasonex (Mometasone Furoate) C Date:02/27/01ISR Number: 3673631-4Report Type:Periodic Company Report #US_000438646 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Prozac PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 25 MG DAY Olanzapine SS 6 MG DAY Date:02/27/01ISR Number: 3673632-6Report Type:Periodic Company Report #US_000438621 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Pain Consumer Prozac PS Lilly Research Initial or Prolonged Face Oedema Laboratories Div Eli Hostility Lilly And Co 20 MG/DAY Zyprexa (Olanzapine) SS 2.5 MG/DAY 1 MON Depakote (Valproate Semisodium) C Clomipramine C Clonidine C 24-Jun-2005 12:19 PM Page: 1316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3673701-0Report Type:Periodic Company Report #US97054927A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Fluoxetine Hcl PS Lilly Research Initial or Prolonged Sedation Professional Laboratories Div Eli Thinking Abnormal Lilly And Co 1000 MG Zyprexa (Olanzapine) SS 300 MG Phenobarbital C Dilantin (Phenytoin Sodium) C Alcohol C Date:02/27/01ISR Number: 3673760-5Report Type:Periodic Company Report #US_991233327 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 40MG / 1 IN THE MORNING Olanzapine SS 10MG /1 DAY Aspirin C Date:02/27/01ISR Number: 3673782-4Report Type:Periodic Company Report #US_990623991 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Consumer Fluoxetine Hcl PS Lilly Research Laboratories Div Eli Lilly And Co 40 MG/1 DAY 6 YR Zyprexa (Olanzapine) SS Valium (Diazepam) C Date:02/27/01ISR Number: 3673794-0Report Type:Periodic Company Report #US_990115610 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Delusion Health Laboratories Div Eli Diarrhoea Professional Lilly And Co 20 MG/1/D DAY Hyperglycaemia Zyprexa (Olanzapine) SS 15 MG/1D DAY Psychotic Disorder Adalat (Nifedipine C Vomiting Lasix (Furosemide) C Lanoxin(Digoxin) C Ativan(Lorazepam) C Cogentin(Benzatropin e Mesilate) C Vitamin E C Vitamin C C Date:02/27/01ISR Number: 3673799-XReport Type:Periodic Company Report #US_981113076 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Hallucination Health Laboratories Div Eli Professional Lilly And Co 20 MG DAY 24-Jun-2005 12:19 PM Page: 1317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine SS 15 MG/D DAY Zestril (Lisinopril) C Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:02/27/01ISR Number: 3673851-9Report Type:Periodic Company Report #US_001153967 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Study Fluoxetine Hcl PS Lilly Research Health Laboratories Div Eli Professional Lilly And Co 5 MG/1 DAY Olanzapine SS 1 MG / 1 DAY Asa (Acetylsalycylic Acid ) C Ativan (Lorazepam) C Glyburide C Glucophage (Metformin Hydrochloride) C Accupril (Quinapril Hydrochloride) C Indocin (Indometacin) C Date:02/27/01ISR Number: 3674412-8Report Type:Periodic Company Report #US_001051320 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Intentional Misuse Health Laboratories Div Eli Suicide Attempt Professional Lilly And Co 25 MG/1 DAY Olanzapine SS 162 MG/DAY Tylenol (Paracetamol) C Bc Powder C Tums C Rolaids (Dihydrooxyaluminium Sodium Carbonate) C Alka-Seltzer C Date:02/27/01ISR Number: 3674415-3Report Type:Periodic Company Report #US_001050938 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 50 MG/1 DAY Olanzapine SS 6 MG/ 1 DAY Tylenol (Paracetamol) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3674417-7Report Type:Periodic Company Report #US_001050921 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 50 MG/1 DAY Olanzapine SS 6 MG/1 DAY Chloral Hydrate C Date:02/27/01ISR Number: 3674420-7Report Type:Periodic Company Report #US_000950743 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co Olanzapine SS Ativan (Lorazepam) C Date:02/27/01ISR Number: 3674423-2Report Type:Periodic Company Report #US_000744830 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Fluoxetine Hcl PS Lilly Research Initial or Prolonged Oedema Laboratories Div Eli Sedation Lilly And Co 20 MG/DAY 5 MIN Weight Increased Zyprexa (Olanzapine) SS 10 MG /DAY 7 WK Date:02/27/01ISR Number: 3674425-6Report Type:Periodic Company Report #US_000744799 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Fluoxetine Hcl PS Lilly Research Initial or Prolonged Phosphatase Increased Professional Laboratories Div Eli Chills Lilly And Co 10 MG/1 DAY 5 YR Dermatitis Zyprexa (Olanzapine) SS 15 MG/1 DAY 6 WK Dysarthria Hyperglycaemia Hyperhidrosis Hypoaesthesia Oedema Pyrexia Sedation Thirst Date:02/27/01ISR Number: 3676486-7Report Type:Periodic Company Report #US_000336610 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Fluoxetine Hcl PS Lilly Research Initial or Prolonged Paranoia Professional Laboratories Div Eli Company Lilly And Co 20 MG/DAY Representative Zyprexa (Olanzapine) SS 20 MG/ 1 AT BEDTIME Depakote (Valproate Semisodium) C (Haloperidol) C 24-Jun-2005 12:19 PM Page: 1319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3676488-0Report Type:Periodic Company Report #US_000236484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Fluoxetine Hcl PS Lilly Research Professional Laboratories Div Eli Company Lilly And Co Representative Zyprexa (Olanzapine) SS Dilantin (Phentoin Sodium) C Depakote (Valproate Semisodium) C Date:02/27/01ISR Number: 3676564-2Report Type:Periodic Company Report #US_000336946 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Drug Dependence Health Laboratories Div Eli Professional Lilly And Co 20 MG Zyprexa (Olanzapine) SS 10 MG Date:02/27/01ISR Number: 3676565-4Report Type:Periodic Company Report #US_000336867 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Fluoxetine Hcl PS Lilly Research Initial or Prolonged Health Laboratories Div Eli Professional Lilly And Co 50 MG Olanzapine SS 12 MG Zestril (Lisinopril) C Ativan (Lorazepam) C Date:02/27/01ISR Number: 3676568-XReport Type:Periodic Company Report #US_000336710 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Study Fluoxetine Hcl PS Lilly Research Health Laboratories Div Eli Professional Lilly And Co 1 DSG FORM/1 IN THE MORNING Olanzapine SS 2 DSG FORM/1 AT BEDTIME Date:02/28/01ISR Number: 3671053-3Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Risperdal 2 Mg Po Hospitalization - Dysarthria Bid PS ORAL 2 MG BID PO Initial or Prolonged Extrapyramidal Disorder Zyprexa 10 Mg X 1 Required Hallucination, Visual Dose SS ORAL 10 MG MS PO Intervention to Heart Rate Increased Trazodone 100 Mg Hs SS 100 MG HS Prevent Permanent Pyrexia Haldol 5 Mg 1m X 1 SS INTRAMUSCULAR 5 MG IM X 1 Impairment/Damage Restlessness Effexor 75 Mg Xr Po Speech Disorder Qd SS ORAL 75 MG XR PO QD 24-Jun-2005 12:19 PM Page: 1320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benztropine 2 Mg Po Bid SS ORAL 2 MG PO BID Cogentin C Effexor C Wellbutrin C Gabapentin C Paxil C Compazine C Meclizine C Trazodone C Acyclovir C Thiamine C Mvi C Unasyin C Date:02/28/01ISR Number: 3671570-6Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa PS ORAL 15 MG PO Hospitalization - Diabetic Coma DAILY HS 2 YR Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage Date:02/28/01ISR Number: 3671738-9Report Type:Expedited (15-DaCompany Report #DE_001203797 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Folate Deficiency Health Mycotoxicosis Professional Pancytopenia Other Pernicious Anaemia Weight Decreased Date:02/28/01ISR Number: 3671739-0Report Type:Expedited (15-DaCompany Report #GBS981101935 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Deficit/Hyperactivity Literature Thyroxine C Disorder Health Delusion Of Grandeur Professional Hallucination, Auditory Other Logorrhoea Mania Date:02/28/01ISR Number: 3672700-2Report Type:Periodic Company Report #9952625 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zoloft PS Pfizer Professional Pharmaceuticals Inc 24-Jun-2005 12:19 PM Page: 1321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prozac SS Zyprexa SS Date:02/28/01ISR Number: 3676158-9Report Type:Periodic Company Report #A013199 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Health Zoloft PS Pfizer Amnesia Professional Pharmaceuticals Inc ORAL 50.00 MG Anxiety TOTAL:DAILY:O Bronchitis RAL Drug Withdrawal Syndrome Azithromycin SS ORAL DAILY:ORAL Increased Appetite Zyprexa SS Insomnia Prevacid C Laryngitis Aspirin C Mental Disorder Celebrex C Rhinitis Valerian C Sedation Unknown Herbal Sinusitis Medication C Sleep Disorder Date:02/28/01ISR Number: 3676183-8Report Type:Periodic Company Report #9934713 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Zoloft PS Pfizer Drug Ineffective Pharmaceuticals Inc ORAL 50.00 MG Haematuria TOTAL:DAILY:O Insomnia RAL Sedation Zyprexa SS Weight Increased Risperdal SS ORAL 1.00 MG TOTAL:DAILY:O RAL Vitamins C Date:02/28/01ISR Number: 3676933-0Report Type:Periodic Company Report #A019726 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zoloft PS Pfizer Delusion Professional Pharmaceuticals Inc ORAL 100.00 MG Dermatitis TOTAL:DAILY:O Infection RAL Leukocytosis Clozapine SS ORAL 400.00 MG Paranoia TOTAL:BID:ORA Pruritus L Schizophreniform Disorder Clonazepam SS ORAL 2.00 MG Speech Disorder TOTAL:DAILY:O RAL Olanzapine SS ORAL 10.00 MG TOTAL:DAILY:O RAL Herbal Supplement C 24-Jun-2005 12:19 PM Page: 1322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3677087-7Report Type:Periodic Company Report #A028304 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Zoloft PS Pfizer Hair Colour Changes Professional Pharmaceuticals Inc 100.00 MG Penis Disorder TOTAL:DAILY Zyprexa SS 10.00 MG TOTAL:DAILY Date:02/28/01ISR Number: 3677381-XReport Type:Periodic Company Report #A003834 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypernatraemia Health Zoloft PS Pfizer Professional Pharmaceuticals Inc Zyprexa SS Date:02/28/01ISR Number: 3679831-1Report Type:Periodic Company Report #A036729 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Consumer Zoloft PS Pfizer Thinking Abnormal Pharmaceuticals Inc 50.00 MG Weight Increased TOTAL Olanzapine SS Date:03/02/01ISR Number: 3672257-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Olanzapine-(Zyprexa) Intervention to 10mg Lilly PS Lilly ORAL 20MG HS ORAL Prevent Permanent Impairment/Damage Date:03/02/01ISR Number: 3673033-0Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Zyprexa (10mg) PS 10MG PER DAY Lorazepam C Date:03/02/01ISR Number: 3673090-1Report Type:Expedited (15-DaCompany Report #002-0184-M0100002 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Benadryl Hcl PS Parke Davis Div Psychotic Disorder Health Warner Lambert Co ORAL 25 MG , PER Professional ORAL Zyprexa (Olanzapine) SS ORAL 5 MG (DAILY), PER ORAL 13 WK 24-Jun-2005 12:19 PM Page: 1323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/01ISR Number: 3673270-5Report Type:Expedited (15-DaCompany Report #01-01-0030 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 600MG QD ORAL Respiratory Disorder Professional Olanzapine Tablets SS ORAL 30MG QD ORAL Lorazepam C Date:03/05/01ISR Number: 3673859-3Report Type:Expedited (15-DaCompany Report #2001045700US Age:35 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Calan PS Gd Searle And Co ORAL ORAL Health Amitriptyline(Amitri Professional ptyline) SS ORAL ORAL Other Olanzapine(Olanzapin e) SS ORAL ORAL Date:03/05/01ISR Number: 3673934-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000862 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Drug Ineffective Health ORAL Neutrophil Count Professional Leponex (Clozapine) SS ORAL 100 MG, Decreased DAILY, ORAL Psychotic Disorder Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, White Blood Cell Count ORAL Decreased Disipal (Orphenadrine Hydrochloride) C Propavan (Propiomazine Maleate) C Zolfot (Sertraline Hydrochloride) C Date:03/05/01ISR Number: 3683523-2Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa Zydis PS Lilly Zydis Apomorphine SS Pentech Pharm/Scherer Dds Date:03/06/01ISR Number: 3674666-8Report Type:Direct Company Report # Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Zyprexa PS ORAL 5MG PO 7AM & Initial or Prolonged Blood Creatine 10MG PO 8.30 Phosphokinase Increased PM Body Temperature Increased Confusional State Decreased Appetite 24-Jun-2005 12:19 PM Page: 1324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/01ISR Number: 3674790-XReport Type:Expedited (15-DaCompany Report #US_000541228 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Zyprexa PS Eli Lilly And Co 12.5 MG/1 AT Life-Threatening Coma Health BEDTIME Other Delusion Professional Valproic Acid C Electrocardiogram Qt Acetaminophen Prolonged W/Hydrocodone Hallucination Bitartrate C Heart Rate Increased Hypokalaemia Hypoxic Encephalopathy Ventricular Fibrillation Date:03/06/01ISR Number: 3674803-5Report Type:Expedited (15-DaCompany Report #GBS010208276 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Glycosylated Haemoglobin Health Risperidone C Increased Professional Venlafaxine C Other Date:03/06/01ISR Number: 3674804-7Report Type:Expedited (15-DaCompany Report #US_010260594 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY 5 WK Parkinson'S Disease Literature L-Dopa C Health Benserazide C Professional Other Date:03/06/01ISR Number: 3674806-0Report Type:Expedited (15-DaCompany Report #AU_010203169 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Increased Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Macrocytosis Health Aropax (Paroxetine Monocyte Count Increased Professional Hydrochloride) C Neutrophil Count Company Increased Representative Other Date:03/06/01ISR Number: 3674807-2Report Type:Expedited (15-DaCompany Report #EWC010225653 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Neutropenia Health Leponex (Clozapine) C White Blood Cell Count Professional Risperdal Decreased Other (Risperidone) C Disipal (Orphenadrine Hydrochloride) C Propavan (Propiomazine 24-Jun-2005 12:19 PM Page: 1325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) C Zoloft (Sertraline Hydrochloride) C Date:03/06/01ISR Number: 3674863-1Report Type:Expedited (15-DaCompany Report #US_000542527 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Zyprexa PS Eli Lilly And Co 12.5 MG/L AT Hospitalization - Hypokalaemia Health BEDTIME Initial or Prolonged Professional Depakote (Valproate Semisodium) C Analgesics C Date:03/06/01ISR Number: 3674881-3Report Type:Expedited (15-DaCompany Report #US_990319499 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Humulin L PS 38 U/DAY Initial or Prolonged Coordination Abnormal Humulin-Human Diabetes Mellitus Regular Insulin Hypoglycaemia (Rdna) (Human Infection Insulin (Rdna Injection Site Fibrosis Origin)) SS Injection Site Reaction Iletin-Insulin-Anima Localised Infection l (Unknown Obsessive-Compulsive Formulation) Personality Disorder (Insulin, Animal) SS Postoperative Infection Zyprexa (Olanzapine) SS 2.5 MG/DAY Scar Humalog-. (Lispro) SS 28 U/DAY Sedation Klonopin Staphylococcal Infection (Clonazepam) C Ulcer Paxil (Paroxetine Urinary Tract Infection Hydrochloride) C Wound Debridement Date:03/06/01ISR Number: 3674896-5Report Type:Expedited (15-DaCompany Report #US_001255762 Age:78 YR Gender:Male I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Blood Chloride Increased Disability Blood Pressure Decreased Coma Confusional State Decreased Appetite Dehydration Fall Femoral Neck Fracture Hip Fracture Hypernatraemia Lethargy Leukocytosis Lymphocyte Count Decreased Neutrophil Count Increased Pain In Extremity Pco2 Increased 24-Jun-2005 12:19 PM Page: 1326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Acute Report Source Product Role Manufacturer Route Dose Duration Study Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Aricept (Donepezil Professional Hydrochloride) C Aspirin C Digoxin C Vasotec (Enalapril Maleate) C Flomax (Morniflumate) C Folic Acid C Metoprolol C Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Ativan (Lorazepam) C Date:03/06/01ISR Number: 3674900-4Report Type:Expedited (15-DaCompany Report #US_010260350 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Initial or Prolonged Pneumonia Health Vitamins Nos C Professional Synthroid (Levothyroxine Sodium) C Miacalcin (Calcitonin, Salmon) C Vitamin E C Ditropan (Oxybutynin) C Premarin Vaginal Cream (Estrogens Conjugated) C Paxil (Paroxetine Hydrochloride) C Wellbutrin (Amfebutamone Hydrochloride) C Date:03/06/01ISR Number: 3674904-1Report Type:Expedited (15-DaCompany Report #US_010260539 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Eli Lilly And Co 5 MG/DAY 7 MON White Blood Cell Count Professional Paxil (Paroxetine Decreased Company Hydrochloride) C Representative Klonopin (Clonazepam) C Norpramin (Desipramine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/01ISR Number: 3674911-9Report Type:Expedited (15-DaCompany Report #US_010260308 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS Eli Lilly And Co 15 MG/DAY 2 WK Professional Date:03/06/01ISR Number: 3674912-0Report Type:Expedited (15-DaCompany Report #US_010156827 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Consumer Zyprexa PS Eli Lilly And Co Hospitalization - Heart Rate Irregular Initial or Prolonged Musculoskeletal Stiffness Myelodysplastic Syndrome Neck Pain Neuroleptic Malignant Syndrome Respiratory Failure Date:03/06/01ISR Number: 3674913-2Report Type:Expedited (15-DaCompany Report #US_010260172 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastrointestinal Health Zyprexa PS Eli Lilly And Co 15 MG/DAY 1 YR Hospitalization - Haemorrhage Professional Initial or Prolonged Hallucination Company Other Pneumonia Representative Respiratory Failure Date:03/06/01ISR Number: 3674915-6Report Type:Expedited (15-DaCompany Report #US_010260377 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa PS Eli Lilly And Co 20 MG/1 AT Respiratory Disorder Professional BEDTIME White Blood Cell Count Other Clozapine C Decreased Lorazepam C Date:03/06/01ISR Number: 3675143-0Report Type:Expedited (15-DaCompany Report #EWC001208794 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Drug Level Above Health Largactil Therapeutic Professional (Chlorpromazine Drug Toxicity Company Hydrochloride) C Sudden Death Representative Other Date:03/06/01ISR Number: 3675145-4Report Type:Expedited (15-DaCompany Report #EWC010225626 Age:83 YR Gender:Male I/FU:I Outcome PT Hospitalization - Body Temperature Initial or Prolonged Increased Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 1328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Professional Other Date:03/06/01ISR Number: 3675151-XReport Type:Expedited (15-DaCompany Report #EWC010225705 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acne Foreign Zyprexa PS Eli Lilly And Co 500 MG DAY Hospitalization - Completed Suicide Health Initial or Prolonged Convulsion Professional Loss Of Consciousness Company Overdose Representative Respiratory Disorder Other Speech Disorder Tachycardia Weight Increased Date:03/06/01ISR Number: 3675153-3Report Type:Expedited (15-DaCompany Report #GBS010208273 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Other Dyskinesia Health Ventolin Epilepsy Professional (Salbutamol) C Loss Of Consciousness Other Beclomethasone C Mydriasis Sudden Death Date:03/06/01ISR Number: 3675154-5Report Type:Expedited (15-DaCompany Report #GBS010208277 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Zyprexa PS Eli Lilly And Co 15 MG Health Valproate Sodium C Professional Other Date:03/06/01ISR Number: 3675344-1Report Type:Expedited (15-DaCompany Report #EWC001108668 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Foreign Zyprexa PS Eli Lilly And Co 10 MG Dyspnoea Health Kemadrin(Procyclidin Epistaxis Professional e Hydrochloride) C Nasal Oedema Company Lexotanil Suffocation Feeling Representative (Bromazepam) C Other 24-Jun-2005 12:19 PM Page: 1329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/01ISR Number: 3675347-7Report Type:Expedited (15-DaCompany Report #EWC010125211 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Weight Increased Health Haloperidol C Professional Other Date:03/06/01ISR Number: 3675350-7Report Type:Expedited (15-DaCompany Report #EWC010125245 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa PS Eli Lilly And Co Health Nozinan Professional (Levomepromazine) C Company Representative Other Date:03/06/01ISR Number: 3675353-2Report Type:Expedited (15-DaCompany Report #EWC001008245 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Haemorrhage Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Thrombocytopenia Health Forlax (Macrogol) C Professional Other Date:03/06/01ISR Number: 3675356-8Report Type:Expedited (15-DaCompany Report #GBS000606151 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Condition Aggravated Consumer Initial or Prolonged Decreased Activity Health Depressed Mood Professional Fall Other Joint Stiffness Lower Respiratory Tract Infection Oedema Peripheral Pain In Extremity Paramnesia Sedation Sensation Of Heaviness Weight Increased Date:03/06/01ISR Number: 3675373-8Report Type:Expedited (15-DaCompany Report #002-0073-M0100018 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Dilantin PS Parke Davis Div Health Warner Lambert Co 300 MG Professional Zyprexa (Olanzapine) SS ORAL 10 MG (DAILY), PER ORAL (Haloperidol) C 24-Jun-2005 12:19 PM Page: 1330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Magnesium) C Phosphate (Sodium Bicarbonate, Potassium Bicarbonate, Sodium Phosphate Monobasic) C (Metoclopramide) C Date:03/06/01ISR Number: 3675401-XReport Type:Expedited (15-DaCompany Report #DE_001204153 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arterial Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Compartment Syndrome Health Stilnox (Zolpidem) C Initial or Prolonged Diplopia Professional Kliogest C Pain In Extremity Other Paraesthesia Peripheral Coldness Pyrexia Renal Impairment Rhabdomyolysis Tachycardia Date:03/06/01ISR Number: 3675613-5Report Type:Expedited (15-DaCompany Report #A104073 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Lithium Carbonate PS Pfizer Inc ORAL ORAL Intervention to Increased Other Ranitidine SS ORAL 300.00 MG Prevent Permanent Aspartate TOTAL:DAILY:O Impairment/Damage Aminotransferase RAL Increased Nefazodone SS ORAL 300.00 MG Blood Alkaline TOTAL:DAILY:O Phosphatase Increased RAL Blood Lactate Olanzapine SS ORAL DAILY:ORAL Dehydrogenase Increased Gamma-Glutamyltransferase Increased Pyrexia Date:03/08/01ISR Number: 3676671-4Report Type:Expedited (15-DaCompany Report #EMADSS2001000835 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bone Marrow Depression Foreign Haldol PS Rw Johnson Health Pharmaceutical Professional Research Institute Div Ortho Pharm ORAL 1, DAILY, ORAL Zyprexa (Olanzapine) SS ORAL ORAL Date:03/09/01ISR Number: 3676473-9Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Life-Threatening Abdominal Pain Chest Pain 24-Jun-2005 12:19 PM Page: 1331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Constipation Gastrointestinal Disorder Heart Rate Irregular Report Source Product Role Manufacturer Route Dose Duration Syncope Zyprexa (15,10,7.5,5,2.5) PS Date:03/09/01ISR Number: 3678494-9Report Type:Expedited (15-DaCompany Report #HQ8114607MAR2001 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Ativan PS Wyeth Ayerst Exposure To Therapeutic Professional Laboratories TRANSPLACENTAL 3.5 1X PER 1 Drugs DAY Somnolence Neonatal TRANSPLACENTA Tremor Neonatal L Olanzapine (Olanzapine) SS TRANSPLACENTAL 25 MG 1X PER 1 DAY TRANSPLACENTA L Date:03/09/01ISR Number: 3678497-4Report Type:Expedited (15-DaCompany Report #HQ8018506MAR2001 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Ativan PS Wyeth Ayerst Pregnancy Professional Laboratories ORAL 3.5 MG 1X PER 1 DAY ORAL Olanzapine (Olanzapine) SS 25 MG 1X PER 1 DAY Date:03/12/01ISR Number: 3680319-2Report Type:Expedited (15-DaCompany Report #US_010260798 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Cognitive Disorder Professional Prozac (Fluoxetine Confusional State Hydrochloride) SS 20 MG/DAY Delirium Depakote (Valproate Medication Error Semisodium) C Muscle Rigidity Trazodone C Negativism Neuroleptic Malignant Syndrome Persecutory Delusion Schizophrenia Date:03/12/01ISR Number: 3680320-9Report Type:Expedited (15-DaCompany Report #US_010260768 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Eli Lilly And Co Professional Company Representative 24-Jun-2005 12:19 PM Page: 1332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680321-0Report Type:Expedited (15-DaCompany Report #US_010260743 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Arrhythmia Company Zyprexa PS Eli Lilly And Co 10 MG/DAY 3 YR Initial or Prolonged Representative Insulin-Insulin-Anim al (Unknown Formulation) (Insulin, Animal) SS Lopressor (Metoprolol Tartrate) C Paxil (Paroxetine Hydrochloride) C Date:03/12/01ISR Number: 3680325-8Report Type:Expedited (15-DaCompany Report #US_010260691 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Deep Vein Thrombosis Health Fluoxetine Dyspnoea Professional (Fluoxetine Heart Rate Increased Hydrochloride) SS Respiratory Rate Mircette C Increased Multiviramin C Prempro C Asa (Acetylsalicylic Acid) C Zantac (Ranitidine Hydrochloride) C Date:03/12/01ISR Number: 3680326-XReport Type:Expedited (15-DaCompany Report #US_010260674 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co (A FEW WEEKS) Professional Company Representative Date:03/12/01ISR Number: 3680327-1Report Type:Expedited (15-DaCompany Report #US_010260640 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Dysphagia Celexa (Citalopram Irritability Hydrobromide) C Renal Failure Date:03/12/01ISR Number: 3680328-3Report Type:Expedited (15-DaCompany Report #US_010260442 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Other Professional Company Representative 24-Jun-2005 12:19 PM Page: 1333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680342-8Report Type:Expedited (15-DaCompany Report #US_991132147 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS Eli Lilly And Co Overdose Professional Toxicologic Test Abnormal Company Representative Date:03/12/01ISR Number: 3680343-XReport Type:Expedited (15-DaCompany Report #US_010157185 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Strangulated Health Zyprexa PS Eli Lilly And Co 15 MG/1 AT Hernia Professional BEDTIME Apnoea Company Clozaril (Clozapine) C Atherosclerosis Representative Klonopin Blood Alcohol Increased (Clonazepam) C Coma Fosinopril C Depressed Level Of Depakote (Valproate Consciousness Semisodium) C Drug Level Above Atenolol C Therapeutic Drug Toxicity Faecaloma Gastritis Gastrointestinal Necrosis Lethargy Sepsis Umbilical Hernia Vomiting Date:03/12/01ISR Number: 3680356-8Report Type:Expedited (15-DaCompany Report #EWC010225704 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Hospitalization - Grand Mal Convulsion Health Zoloft (Sertraline Initial or Prolonged Sudden Death Professional Hydrocholride) C Company Trilafon C Representative Pamol (Paracetamol) C Other Benzodiazepine C Date:03/12/01ISR Number: 3680357-XReport Type:Expedited (15-DaCompany Report #EWC010225701 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Hospitalization - Grand Mal Convulsion Health Serenase Initial or Prolonged Sedation Professional (Haloperidol) C Company Loxapac (Loxapine Representative Succinate) C Other Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 1334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680358-1Report Type:Expedited (15-DaCompany Report #DE_010205142 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/ 1 DAY Hospitalization - Health Hypnorex (Lithium Initial or Prolonged Professional Carbonate) C Other Date:03/12/01ISR Number: 3680359-3Report Type:Expedited (15-DaCompany Report #EWC010325779 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Viral Infection Health Professional Other Date:03/12/01ISR Number: 3680360-XReport Type:Expedited (15-DaCompany Report #EWC010225742 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Foreign Zyprexa PS Eli Lilly And Co 10 MG /AT Haemorrhage Health BEDTIME Iron Deficiency Anaemia Professional Remeron Other (Mirtazapine) C Edronax (Reboxetine) C Date:03/12/01ISR Number: 3680361-1Report Type:Expedited (15-DaCompany Report #GBS010208313 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Hospitalization - Body Temperature Health Calcitriol C Initial or Prolonged Decreased Professional Ipratropium C Depressed Level Of Other Gastrocote C Consciousness Ecchymosis Fall Humerus Fracture Injury Limb Injury Pallor Sudden Death Date:03/12/01ISR Number: 3680362-3Report Type:Expedited (15-DaCompany Report #GBS010208307 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Oedema Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Sudden Death Health Procyclidine C Professional Other 24-Jun-2005 12:19 PM Page: 1335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680363-5Report Type:Expedited (15-DaCompany Report #EWC010325786 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Health Professional Other Date:03/12/01ISR Number: 3680518-XReport Type:Expedited (15-DaCompany Report #2000UW01591 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS Astrazeneca Uk Ltd ORAL 250 MG HS PO 10 WK Intervention to Visual Acuity Reduced Professional Zyprexa SS Prevent Permanent Risperdal SS Impairment/Damage Date:03/12/01ISR Number: 3680609-3Report Type:Expedited (15-DaCompany Report #US_010360889 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS Eli Lilly And Co 1 YR Initial or Prolonged Increased Appetite Professional Trileptal Psychotic Disorder (Oxcarbazepine) C Weight Increased Depakote C Date:03/12/01ISR Number: 3680648-2Report Type:Expedited (15-DaCompany Report #US_010260735 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Zyprexa (Olanzapine) PS Eli Lilly And Co 5 MG/DAY Sedation Depakote (Valproate Thirst Semisodium) C Cogentin (Benzatropine Mesilate) C Prosom (Estazolam) C Date:03/12/01ISR Number: 3680651-2Report Type:Expedited (15-DaCompany Report #US_010260731 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Zyprexa (Olanzapine) PS Eli Lilly And Co Initial or Prolonged Pneumothorax Professional Albuterol C Company Representative Date:03/12/01ISR Number: 3680696-2Report Type:Expedited (15-DaCompany Report #GBS010208304 Age:48 YR Gender:Male I/FU:I Outcome PT Death Atherosclerosis Other Bundle Branch Block Right Chest Pain Coronary Artery Disease Electrocardiogram St 24-Jun-2005 12:19 PM Page: 1336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Segment Elevation Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 20 MG Health Professional Other Date:03/12/01ISR Number: 3680731-1Report Type:Expedited (15-DaCompany Report #1818977-2001-00179 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Dependence Foreign Kemadrin PS Monarch Pulmonary Embolism Health Pharmaceuticals Inc ORAL 5MG/3XDAY/ORA Sudden Death Professional L Olanzapine (Olanzapine) SS ORAL 5MG 2XDAY/ORAL Date:03/12/01ISR Number: 3680856-0Report Type:Expedited (15-DaCompany Report #DE_010104807 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Increased Health Coronary Artery Disease Professional Dyspnoea Other Myocardial Ischaemia Date:03/12/01ISR Number: 3680858-4Report Type:Expedited (15-DaCompany Report #DE_001103396 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Increased Health Lithium C Aspartate Professional Lyogen Aminotransferase Other (Fluphenazine) C Increased Gamma-Glutamyltransferase Increased Liver Disorder Date:03/12/01ISR Number: 3681250-9Report Type:Expedited (15-DaCompany Report #AU_010203143 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Health Citalopram C Professional Company Representative 24-Jun-2005 12:19 PM Page: 1337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3681252-2Report Type:Expedited (15-DaCompany Report #EWC010225551 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Increased Health Solian(Amisulpride) C Blood Creatine Professional Xanax C Phosphokinase Increased Pruritus C Condition Aggravated Oedema Peripheral Pruritus Thrombocythaemia Date:03/12/01ISR Number: 3681253-4Report Type:Expedited (15-DaCompany Report #DE_010205161 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Decreased Health Valiquid(Diazepam) C Professional Date:03/12/01ISR Number: 3681254-6Report Type:Expedited (15-DaCompany Report #US_010360977 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypomania Foreign Zyprexa PS Eli Lilly And Co 10 MG/1DAY Mania Literature Health Professional Date:03/12/01ISR Number: 3681255-8Report Type:Expedited (15-DaCompany Report #EWC010325772 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Professional Date:03/12/01ISR Number: 3681256-XReport Type:Expedited (15-DaCompany Report #EWC010225759 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haemodialysis Foreign Zyprexa PS Eli Lilly And Co 28 DSG Hospitalization - Pyrexia Health FORM/DAY Initial or Prolonged Renal Impairment Professional Teralithe (Lithium Respiratory Distress Carbonate) C Rhabdomyolysis Tercian C Shock Suicide Attempt Date:03/13/01ISR Number: 3679849-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Zydis SS 24-Jun-2005 12:19 PM Page: 1338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/01ISR Number: 3680171-5Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Zyprexa (Olanzapine) Initial or Prolonged Apathy 10mg PS ORAL 10MG PO BID Depression Buspirone C Fatigue Bupropion C Hordeolum Tremor Date:03/14/01ISR Number: 3680973-5Report Type:Expedited (15-DaCompany Report #01P-163-0103966-00 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Depakote PS Abbott Laboratories ORAL 250 MG, 2 IN Drug Interaction 1 D, PER ORAL Thirst Prosom 2mg (Prosom) (Estazolam) SS ORAL 2 MG, 1 IN 1 D, PER ORAL Benzatropine Mesilate (Benzatropine Mesilate) SS ORAL 2 MG, 1 IN 1 D, PER ORAL Olanzapine (Olanzapine) SS ORAL 2.5 MG, 1 IN 1 D, PER ORAL Date:03/16/01ISR Number: 3683050-2Report Type:Expedited (15-DaCompany Report #PHEH2001US02179 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Exelon PS Novartis Confusional State Professional Pharmaceuticals Corp ORAL 6 MG, BID, Paranoia Company ORAL Sedation Representative Zyprexa (Olanzapine SS ORAL ORAL Weight Increased Date:03/19/01ISR Number: 3682881-2Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Klonopin (2 Mg Tid) PS Initial or Prolonged Risperdol (4mg Hs) SS Luvox 100 Mg Bid SS Zyprexa Po 200 SS Date:03/19/01ISR Number: 3684127-8Report Type:Expedited (15-DaCompany Report #EWC010225349 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aspartate Foreign Zyprexa PS Eli Lilly And Co 7.5 MG DAY Aminotransferase Health Tranxene Increased Professional (Clorazepate Blood Creatine Other Dipotassium) C Phosphokinase Increased ... C Eosinophilia 24-Jun-2005 12:19 PM Page: 1339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/01ISR Number: 3684131-XReport Type:Expedited (15-DaCompany Report #EWC010225512 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Alanine Aminotransferase Health Prozac (Fluoxetine Increased Professional Hydrochloride) C Aspartate Company Aminotransferase Representative Increased Other Asthenia Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Hepatocellular Damage Nausea Vomiting Date:03/19/01ISR Number: 3684133-3Report Type:Expedited (15-DaCompany Report #EWC010225791 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa PS Eli Lilly And Co Exposure To Therapeutic Health Serlain (Sertaline) C Drugs Professional Edronax (Reboxetine) C Hydroureter Company Kidney Malformation Representative Pregnancy Other Date:03/19/01ISR Number: 3684135-7Report Type:Expedited (15-DaCompany Report #EWC010325807 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Increased Health Cipramil (Citalopram Blood Bilirubin Increased Professional Hydrobromide) C Blood Lactate Other Temesta (Lorazepam) C Dehydrogenase Increased C-Reactive Protein Increased Deep Vein Thrombosis Gamma-Glutamyltransferase Increased Haemoglobin Decreased Laboratory Test Abnormal Platelet Count Abnormal Red Blood Cell Sedimentation Rate Increased Sensation Of Heaviness Date:03/19/01ISR Number: 3684171-0Report Type:Expedited (15-DaCompany Report #GBS010308346 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa PS Eli Lilly And Co 60 MG/DAY Initial or Prolonged Gastric Haemorrhage Health Lofepramine C Professional Procyclidine C Other Gaviscon C 24-Jun-2005 12:19 PM Page: 1340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/01ISR Number: 3684174-6Report Type:Expedited (15-DaCompany Report #GBS010308372 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperthyroidism Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Venlafaxine C Professional Other Date:03/19/01ISR Number: 3684189-8Report Type:Expedited (15-DaCompany Report #EWC001008359 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Urinary Retention Health Mopral (Omeprazole) C Professional Company Representative Other Date:03/19/01ISR Number: 3684193-XReport Type:Expedited (15-DaCompany Report #EWC001008084 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Mucosal Dryness Health Professional Other Date:03/19/01ISR Number: 3684196-5Report Type:Expedited (15-DaCompany Report #EWC000908077 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Blood Creatine Health Phosphokinase Increased Professional Myalgia Company Neutropenia Representative Other Date:03/19/01ISR Number: 3684325-3Report Type:Expedited (15-DaCompany Report #US_010360827 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Loss Of Consciousness Professional Muscle Twitching Renal Failure Acute Rhabdomyolysis Date:03/19/01ISR Number: 3684327-7Report Type:Expedited (15-DaCompany Report #US_010361075 Age:20 YR Gender:Female I/FU:I Outcome PT Other Agitation Condition Aggravated Electrocardiogram Qt 24-Jun-2005 12:19 PM Page: 1341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co 5 MG/1 AT Professional BEDTIME Ambien (Zolpidem Tartrate) C Date:03/19/01ISR Number: 3684376-9Report Type:Expedited (15-DaCompany Report #US_010259111 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Study Zyprexa PS Eli Lilly And Co 10 MG/AT Initial or Prolonged Haemorrhage Health BEDTIME Disability Myocardial Infarction Professional Combivent C Other Flovent (Fluticasone Propionate) C Levobunolol C Date:03/19/01ISR Number: 3684381-2Report Type:Expedited (15-DaCompany Report #US_010361329 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Zyprexa PS Eli Lilly And Co 20 MG/1 AT Professional BEDTIME 45 WK Date:03/19/01ISR Number: 3684385-XReport Type:Expedited (15-DaCompany Report #US_010361575 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Haemoglobin Decreased Professional Company Representative Date:03/19/01ISR Number: 3684468-4Report Type:Expedited (15-DaCompany Report #US_010157428 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Zyprexa PS Eli Lilly And Co 10 MG/4 DAY 2 YR Optic Atrophy Lithonate (Lithium Parkinsonism Carbonate) C Scleral Disorder Eskalith (Lithium Screaming Carbonate) C Visual Acuity Reduced Luvox (Fluvoxamine Maleate) C Zaditor (Ketotifen) C Allegra (Fexofenadine Hydrochloride) C Synthroid (Levothyroxine Sodium) C Nasonex (Mometasone Furoate) C 24-Jun-2005 12:19 PM Page: 1342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/01ISR Number: 3684472-6Report Type:Expedited (15-DaCompany Report #US_000337022 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Hospitalization - Anaemia Health BEDTIME Initial or Prolonged Apnoea Professional Albuterol C Bradycardia Aricept (Donepezil Cardiac Failure Hydrochloride) C Congestive Artificial Tears C Cellulitis Aspirin (E.C.) Chronic Obstructive (Acetylsalicylic Airways Disease Acid) C Exacerbated Atrovent Coma (Ipratropium Condition Aggravated Bromide) C Diabetes Mellitus Furosemide C Dyspnoea Lanoxin (Digoxin) C Eye Movement Disorder Multivitamin C Hyperkalaemia Norvasc (Amlodipine Hyperlipidaemia Besilate) C Hypertension Insulin Novolin Hyponatraemia 70/30 C Hypotonia Phoslo (Calcium Lethargy Acetate) C Oedema Prinivil Pallor (Lisinopril) C Pneumonia Regulopid (Psyllium) C Pupil Fixed Trazodone C Renal Failure Acute Vitamin C C Respiratory Failure Vitamin E C Zoloft (Sertraline Hydrochloride) C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Ferrous Sulfate C Colace (Docusate Sodium) C Cortisporin Cream C Hydrocortisone C Azmacort (Triamcinolone Acetonide) C Cartia (Acetylsalicylic Acid) C Famvir (Famciclovir) C Cardizem Cd (Diltiazem Hydrochloride) C Hydralazine C K-Dur (Potassium Chloride) C Zaroxolyn (Metolazone) C Epogen (Epoetin Alfa) C Prednisone C Prevacid (Lansoprazole) C 24-Jun-2005 12:19 PM Page: 1343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vicodin C Ativan (Lorazepam) C Kayexalate (Sodium Polystyrene Sulfonate) C Glucagon C Lacydrin C Domeboro C Bactroban (Mupirocin) C Nystatin C Combivent C Ambien (Zolpidem Tartrate) C Bisacodyl C Pepcid (Famotidine) C Date:03/19/01ISR Number: 3684606-3Report Type:Expedited (15-DaCompany Report #US_010360929 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akinesia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 2 MON Other Condition Aggravated Literature L-Dopa C Decubitus Ulcer Health Difficulty In Walking Professional Hallucination Other Insomnia Pneumonia Respiratory Failure Sedation White Blood Cell Count Increased Date:03/19/01ISR Number: 3684607-5Report Type:Expedited (15-DaCompany Report #US_010360854 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 10MG/1 DAY 1 DAY Electrocardiogram Qt Literature Perphenazine C Prolonged Health Hypotension Professional Hypothermia Other Loss Of Consciousness Sedation Date:03/19/01ISR Number: 3684620-8Report Type:Expedited (15-DaCompany Report #EWC001108686 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Zyprexa PS Eli Lilly And Co 20 MG Initial or Prolonged Decreased Health Artane White Blood Cell Count Professional (Trihexyphenidyl Increased Company Hydrochloride) C Representative Zoloft (Sertraline Other Hydrochloride) C Tenormin (Atenolol) C Eurodin (Estazolam) C Magnesium Oxide C 24-Jun-2005 12:19 PM Page: 1344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/01ISR Number: 3684622-1Report Type:Expedited (15-DaCompany Report #EWC010225531 Age:2 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Septal Defect Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Complications Of Maternal Company Citalopram C Congenital Anomaly Exposure To Therapeutic Representative Drugs Other Cyanosis Oedema Peripheral Postmature Baby Ventricular Septal Defect Date:03/19/01ISR Number: 3684624-5Report Type:Expedited (15-DaCompany Report #EWC010225701 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blunted Affect Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Hospitalization - Convulsion Health Serenase Initial or Prolonged Grand Mal Convulsion Professional (Haloperidol) C Sedation Company Loxapac (Loxapine Representative Succinate) C Other Risperdal (Risperidone) C Date:03/19/01ISR Number: 3684697-XReport Type:Expedited (15-DaCompany Report #2000AP01195 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Albumin Increased Foreign Seroquel PS Astrazeneca Uk Ltd 300 MG DAILY Blood Alkaline Health Zyprexa SS ORAL 10 MG DAILY Phosphatase Increased Professional PO Polycythaemia Other Zyprexa SS ORAL 10 MG DAILY White Blood Cell Count PO Decreased Date:03/20/01ISR Number: 3685175-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Zyprexa (5mg) PS ORAL 5MG PO QD 2 DAY Initial or Prolonged Remeron C Other Senekot-S C Xanax C Aleve C Mom C Date:03/26/01ISR Number: 3689504-7Report Type:Direct Company Report #USP 53810 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa Zydis Tablet, Disintegrating PS Lilly Zydis Tablet SS Genetech Pharm/ Scherer Monograph For Apomorphine (Zydis) SS 24-Jun-2005 12:19 PM Page: 1345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3689831-3Report Type:Expedited (15-DaCompany Report #US_010361867 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Therapeutic Professional Permax (Pergolide Mesylate) SS 1 MG/2 DAY Topamax (Tpiramate) C Clonazepam C Vistaril (Hydroxyzine Embonate) C Desmopressin C Decadron (Dexamethasone) C Lasix (Furosemide) C Cardizem Cd (Diltiazem Hydrochloride) C Date:03/26/01ISR Number: 3689834-9Report Type:Expedited (15-DaCompany Report #US_010361657 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperosmolar Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Coma Professional Other Influenza Like Illness Pneumonia Pulmonary Embolism Renal Failure Upper Gastrointestinal Haemorrhage Weight Increased Date:03/26/01ISR Number: 3689835-0Report Type:Expedited (15-DaCompany Report #US_010361816 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Maculopathy Health Zyprexa PS Eli Lilly And Co Retinal Disorder Professional Date:03/26/01ISR Number: 3690078-5Report Type:Expedited (15-DaCompany Report #US_010156827 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Hospitalization - Heart Rate Irregular Health Initial or Prolonged Mental Impairment Professional Musculoskeletal Stiffness Myelodysplastic Syndrome Neck Pain Neuroleptic Malignant Syndrome Pain Respiratory Failure Sinusitis 24-Jun-2005 12:19 PM Page: 1346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3690079-7Report Type:Expedited (15-DaCompany Report #US_010157105 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa PS Eli Lilly And Co 15 MG/2 DAY Initial or Prolonged Aggression Professional Quetiapine C Difficulty In Walking Klonopin(Clonazepam) C Dizziness Tegretol Swelling (Carbamazepine) C Tremor Remeron(Mirtazapine) C Trismus Haldol (Haloperidol) C Weight Increased Date:03/26/01ISR Number: 3690080-3Report Type:Expedited (15-DaCompany Report #US_010260377 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Initial or Prolonged Mental Impairment Professional Clozapine C Other Neutropenia Other Lorazepam C Pneumonia Psychotic Disorder Respiratory Disorder Screaming Speech Disorder Thinking Abnormal Viral Infection White Blood Cell Count Decreased Date:03/26/01ISR Number: 3690081-5Report Type:Expedited (15-DaCompany Report #US_000337022 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Study Zyprexa PS Eli Lilly And Co 2.5 MG/1 AT Hospitalization - Blood Potassium Decreased Health BEDTIME Initial or Prolonged Blood Potassium Increased Professional Albuterol C Bradycardia Aricept (Donepezil Cardiac Failure Hydrochloride) C Congestive Artificial Tears C Cellulitis Aspirin (E.C.) Coma (Acetylsalicylic Face Oedema Acid) C Hypotension Atrovent Pneumonia (Ipratropium Pulmonary Oedema Bromide) C Pupil Fixed Furosemide C Renal Failure Acute Lanoxin (Digoxin) C Respiratory Failure Multivitamin C Norvasc (Amlodipine Besilate) C Insulin Novolin 70/30 C Phoslo (Calcium Acetate) C Prinivil (Lisinopril) C Reguloid (Psyllium) C Trazodone C Vitamin C C 24-Jun-2005 12:19 PM Page: 1347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin E C Zoloft (Sertraline Hydrochloride) C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Colace (Docusate Sodium) C Cortisporin Cream C Hydrocortisone C Azmacort(Triamcinolo ne Acetonide) C Diltiazem C Famvir (Famciclovir) C Cardizem Cd(Diltiazem Hydrochloride) C Hydralazine C K-Dur (Potassium Chloride) C Zaroxolyn (Metolazone) C Epogen (Epoetin Alfa) C Prednisone C Prevacid (Lansoprazole) C Vicodin C Ativan (Lorazepam) C Kayexalate (Sodium Polystyrene Sulfonate) C Glucagon C Lacydrin C Domeboro C Bactroban (Mupirocin) C Nystatin C Combivent C Ambien(Zolpidem Tartrate) C Bisacodyl C Pepcid(Famotidine) C Ferrous Sulfate C Date:03/26/01ISR Number: 3690108-0Report Type:Expedited (15-DaCompany Report #US_010361653 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zyprexa PS Eli Lilly And Co Professional Company Representative 24-Jun-2005 12:19 PM Page: 1348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3690109-2Report Type:Expedited (15-DaCompany Report #US_010361601 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Life-Threatening Cardio-Respiratory Arrest Professional Other Dizziness Company Fall Representative Head Injury Sepsis Date:03/26/01ISR Number: 3690110-9Report Type:Expedited (15-DaCompany Report #US_010361507 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complication Of Delivery Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Complications Of Maternal Professional Exposure To Therapeutic Drugs Lethargy Neonatal Disorder Pyrexia Social Avoidant Behaviour Tachypnoea Tremor Date:03/26/01ISR Number: 3690111-0Report Type:Expedited (15-DaCompany Report #US_010361491 Age:5 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa PS Eli Lilly And Co Exposure To Therapeutic Professional Drugs Drug Withdrawal Syndrome Neonatal Lethargy Neonatal Disorder Obstructed Labour Pyrexia Tachypnoea Tremor Neonatal Date:03/26/01ISR Number: 3690112-2Report Type:Expedited (15-DaCompany Report #US_010260062 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Diabetic Ketoacidosis Professional Haldol Decanoate Disorientation Company (Haloperidol Respiratory Failure Representative Decanoate) C Weight Increased Date:03/26/01ISR Number: 3690113-4Report Type:Expedited (15-DaCompany Report #US_010260014 Age:46 YR Gender:Male I/FU:I Outcome PT Hospitalization - Dermatitis Initial or Prolonged Hypersensitivity 24-Jun-2005 12:19 PM Page: 1349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Laryngeal Oedema Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Humulin-Human Company Insulin (Rdna) Representative Unkown Formulation (Human Insulin (Rdna Origin)) SS Norvasc (Amlodipine Besilate) C Date:03/26/01ISR Number: 3690134-1Report Type:Expedited (15-DaCompany Report #US_001154483 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa PS Eli Lilly And Co 2.5 MG/ DAY 3 WK Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Metoprolol C Levothyroxine C Effexor (Venlafaxine Hydrochloride C Date:03/26/01ISR Number: 3690135-3Report Type:Expedited (15-DaCompany Report #US_010259111 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS Eli Lilly And Co 10 MG/AT Initial or Prolonged Dyspnoea Health BEDTIME Gastrointestinal Professional Ecotrin Haemorrhage (Acetylsalicylic Myocardial Infarction Acid) SS Combivent C Flovent (Fluticasone Propionate) C Levobunolol C Lipitor (Atrovastatin) C Atenolol C Date:03/26/01ISR Number: 3690136-5Report Type:Expedited (15-DaCompany Report #US_000643547 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adenoma Benign Study Olanzapine PS Eli Lilly And Co 2 DSG FORM Hospitalization - Blood Pressure Decreased Health Sertraline C Initial or Prolonged Cerebrovascular Accident Professional Donepezil C Coma Vitamin E C Condition Aggravated Aspirin C Diverticulitis Iron C Haematochezia Bisacodyl C Rectal Haemorrhage 24-Jun-2005 12:19 PM Page: 1350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3690141-9Report Type:Expedited (15-DaCompany Report #US_010260768 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epistaxis Health Zyprexa PS Eli Lilly And Co Fall Professional Cozaar (Losartan Intentional Misuse Company Potassium) C Suicide Attempt Representative Neurontin (Gabapentin) C Trileptal (Oxcarbazepine) C Flonase (Fluticasone Propionate) C Vitamin B12 C Date:03/26/01ISR Number: 3690208-5Report Type:Expedited (15-DaCompany Report #EWC010225438 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Initial or Prolonged Back Pain Health Tercian Hypotension Professional (Cyamemazine) C Pulmonary Embolism Company Heptaminol C Pyrexia Representative Diane-35 C Other Date:03/26/01ISR Number: 3690209-7Report Type:Expedited (15-DaCompany Report #EWC010325854 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Health Professional Other Date:03/26/01ISR Number: 3690215-2Report Type:Expedited (15-DaCompany Report #GBS010108133 Age:41 YR Gender:Female I/FU:F Outcome PT Death Abdominal Distension Hospitalization - Abdominal Pain Initial or Prolonged Abdominal Pain Upper Atherosclerosis Cardiomegaly Confusional State Coronary Artery Disease Ecchymosis Heart Rate Increased Hepatic Congestion Hepatic Steatosis Hypertension Lung Consolidation Lung Disorder Malaise Metabolic Acidosis Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant 24-Jun-2005 12:19 PM Page: 1351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Pulmonary Congestion Pulmonary Oedema Pyrexia Report Source Product Role Manufacturer Route Dose Duration Renal Disorder Foreign Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Respiratory Rate Consumer Procyclidine C Increased Health Atenolol C Skin Ulcer Professional Zopiclone C Spleen Disorder Company Haloperidol C Vomiting Representative Other Date:03/26/01ISR Number: 3690217-6Report Type:Expedited (15-DaCompany Report #GBS010108152 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Aspartate Health Depizol (Flupentixol Initial or Prolonged Aminotransferase Professional Decanoate) C Increased Company Atrial Flutter Representative Blood Alkaline Other Phosphatase Increased Blood Lactate Dehydrogenase Increased Bronchopneumonia Disseminated Intravascular Coagulation Hypotension Lower Respiratory Tract Infection Peptic Ulcer Perforation Renal Impairment Sepsis Tremor Viral Upper Respiratory Tract Infection Date:03/26/01ISR Number: 3690218-8Report Type:Expedited (15-DaCompany Report #AU_001202472 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa PS Eli Lilly And Co Cardiomyopathy Health Cipramil Hyperhidrosis Professional (Citalopram Oxygen Saturation Company Hydrobromide) C Decreased Representative Pallor Other Date:03/26/01ISR Number: 3690222-XReport Type:Expedited (15-DaCompany Report #GBS010208307 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Oedema Foreign Zyprexa PS Eli Lilly And Co 10 MG/ DAY Sudden Death Health Procyclidine C Professional Other 24-Jun-2005 12:19 PM Page: 1352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3690266-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU02737 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Anafranil PS Novartis Complications Of Maternal Health Pharmaceuticals Corp ORAL 100 MG/DAY, Exposure To Therapeutic Professional ORAL Drugs Other Zyprexa (Olanzapine) SS ORAL 20 MG/DAY, ORAL Atovastatin C Nitrazepam C Lipitor (Atorvastatin) C Mogadon C Date:03/26/01ISR Number: 3690315-7Report Type:Expedited (15-DaCompany Report #GBS010308394 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glucose Tolerance Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Impaired Health Chlorpromazine C Professional Procyclidine C Other Date:03/26/01ISR Number: 3690317-0Report Type:Expedited (15-DaCompany Report #DE_001203872 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Congestive Health Paroxetin Condition Aggravated Professional (Paroxetine) C Erythema Infectiosum Novodigal(Dogoxin) C Myocarditis Promethazine C Pulmonary Congestion Date:03/26/01ISR Number: 3690320-0Report Type:Expedited (15-DaCompany Report #CA_010303362 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa PS Eli Lilly And Co Exposure To Therapeutic Health Drugs Professional Spina Bifida Company Representative Other Date:03/26/01ISR Number: 3690322-4Report Type:Expedited (15-DaCompany Report #GBS010108142 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Oedema Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Sudden Death Health Procyclidine C Professional Fluphenazine Company Decanoate C Representative Other 24-Jun-2005 12:19 PM Page: 1353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3690325-XReport Type:Expedited (15-DaCompany Report #GBS010308440 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co Health Professional Date:03/26/01ISR Number: 3690326-1Report Type:Expedited (15-DaCompany Report #EWC010325860 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Hyponatraemia Health Akineton(Biperiden Neutropenia Professional Hydrochloride) C Oral Candidiasis Stilnox(Zolpidem) C Pyrexia Upper Respiratory Tract Infection Date:03/26/01ISR Number: 3691644-3Report Type:Expedited (15-DaCompany Report #US_000745495 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Placental Disorder Professional Paxil (Paroxetine Pregnancy Company Hydrochloride) C Representative Date:03/29/01ISR Number: 3691381-5Report Type:Expedited (15-DaCompany Report #257291 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Valium PS Roche 8 DAY Initial or Prolonged Anafranil SS Zyprexa SS Tavor SS 1 DAY Heparin C 2 DAY Date:03/29/01ISR Number: 3692317-3Report Type:Expedited (15-DaCompany Report #EWC001108595 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Gastritis Health Glucophage Hepatic Steatosis Professional (Metformin Oesophagitis Company Hydrochloride) C Pancreatitis Acute Representative Scar Other Date:03/30/01ISR Number: 3693365-XReport Type:Expedited (15-DaCompany Report #HQ8980428MAR2001 Age:49 YR Gender:Female I/FU:I Outcome PT Hospitalization - Circulatory Collapse Initial or Prolonged Fall Other Haemorrhage 24-Jun-2005 12:19 PM Page: 1354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Laceration Orthostatic Hypotension Report Source Product Role Manufacturer Route Dose Duration Foreign Ativan PS Wyeth Ayerst Study Laboratories ORAL 2.5 MG 1X PER 1 DAY 1 DAY Clomipramine (Clomipramine,) SS ORAL SEE IMAGE 4 DAY Diazepam (Diazepam) SS ORAL 20 MG 1X PER 1 DAY, 15 MG 1XPER 1 DAY, 10 MG 1X PER 1 DAY, 5 MG 4 DAY Olanzapine (Olanzapine) SS ORAL 15 MG 1X PER 1 DAY, 20 MG 1X PER 1 DAY 27 DAY Heparin (Heparin) C Date:03/31/01ISR Number: 3693527-1Report Type:Expedited (15-DaCompany Report #257291 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Foreign Valium PS Hoffmann La Roche Initial or Prolonged Circulatory Collapse Study Inc ORAL 20 MG DAILY Concussion Health ORAL Dizziness Postural Professional Anafranil Electrocardiogram (Clomipramine Abnormal Hydrochloride) SS ORAL 150 MG DAILY Fall ORAL Headache Zyprexa (Olanzapine) SS ORAL 20 MG DAILY Hypotension ORAL Insomnia Tavor (Lorazepam) SS ORAL 2.5 MG DAILY Laceration ORAL Loss Of Consciousness Heparin (Heparin Malaise Sodium) C Skull Fracture Date:04/03/01ISR Number: 3695231-2Report Type:Expedited (15-DaCompany Report #US_010362167 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Agitation Literature Condition Aggravated Health Hallucination, Auditory Professional Leukopenia Other Neutropenia Psychomotor Hyperactivity Psychotic Disorder Date:04/03/01ISR Number: 3695234-8Report Type:Expedited (15-DaCompany Report #US_010362156 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Other Leukopenia Foreign Literature Health 24-Jun-2005 12:19 PM Page: 1355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 20 MG/DAY Date:04/03/01ISR Number: 3695236-1Report Type:Expedited (15-DaCompany Report #US_010362146 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Literature Health Professional Other Date:04/03/01ISR Number: 3695433-5Report Type:Expedited (15-DaCompany Report #US_010362253 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Prozac PS Lilly Research Initial or Prolonged Increased Professional Laboratories Div Eli Aspartate Lilly And Co 60 MG/DAY 2 YR Aminotransferase Zyprexa (Olanzapine) SS 10 MG/DAY 4 MON Increased Cogentin Schizophrenia (Benzatropine Mesilate) C Buspar (Buspirone Hydrochloride) C Coenzyme A C Serzone (Nefazodone Hydrochloride) C Date:04/03/01ISR Number: 3695437-2Report Type:Expedited (15-DaCompany Report #US_010259819 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Zyprexa PS Eli Lilly And Co 15 MG/L AT Hospitalization - Aspartate Professional BEDTIME Initial or Prolonged Aminotransferase Company Disability Increased Representative Cerebrovascular Accident Coma Diabetic Ketoacidosis Encephalopathy Hyperglycaemia Influenza Like Illness Pancreatitis Date:04/03/01ISR Number: 3695438-4Report Type:Expedited (15-DaCompany Report #US_010260244 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gingival Hyperplasia Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Professional BEDTIME Company Serzone (Nefazodone Representative Hydrochloride) C Remeron 24-Jun-2005 12:19 PM Page: 1356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mirtazapine) C Clozapine C Lorazepam C Date:04/03/01ISR Number: 3695439-6Report Type:Expedited (15-DaCompany Report #US_010361993 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gangrene Health Zyprexa PS Eli Lilly And Co Renal Failure Professional Date:04/03/01ISR Number: 3695440-2Report Type:Expedited (15-DaCompany Report #US_010361896 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Prolonged Professional BEDTIME Plavix (Clopidogrel Sulfate) C Metoprolol C Pepcid (Famotidine) C Wellbutrin (Amfebutamone Hydrochloride) C Aspirin C Enoxaparin C Klonopin (Clonazepam) C Date:04/03/01ISR Number: 3695463-3Report Type:Expedited (15-DaCompany Report #US_010360889 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa PS Eli Lilly And Co 1 YR Initial or Prolonged Condition Aggravated Professional Trileptal Other Drug Level Above (Oxcarbazepine) C Therapeutic Depakote (Valproate Increased Appetite Semisodium) C Psychotic Disorder Weight Increased Date:04/03/01ISR Number: 3695464-5Report Type:Expedited (15-DaCompany Report #US_010260429 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Dependence Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Overdose Professional Company Representative Date:04/03/01ISR Number: 3695465-7Report Type:Expedited (15-DaCompany Report #US_010157105 Age:38 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Difficulty In Walking Dizziness 24-Jun-2005 12:19 PM Page: 1357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Joint Stiffness Schizophrenia Swelling Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Eli Lilly And Co 15 MG/2 DAY Weight Increased Professional Quetiapine C Klonopin (Clonazepam) C Tegretol (Carbamazepine) C Remeron (Mirtazapine) C Haldol (Haloperidol) C Date:04/03/01ISR Number: 3695466-9Report Type:Expedited (15-DaCompany Report #US_000643547 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adenoma Benign Study Zyprexa PS Eli Lilly And Co 2 DSG FORM Hospitalization - Benign Colonic Neoplasm Health Sertraline C Initial or Prolonged Blood Pressure Decreased Professional Donepezil C Cerebrovascular Accident Vitamin E C Coma Aspirin C Diverticulitis Iron C Haematocrit Decreased Dulcolax (Bisacodyl) C Haemoglobin Decreased Bisacodyl C Rectal Haemorrhage Red Blood Cell Count Decreased Date:04/03/01ISR Number: 3695918-1Report Type:Expedited (15-DaCompany Report #GBS000205354 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa PS Eli Lilly And Co Brain Oedema Health Reboxetine C Coronary Artery Disease Professional Clonazepam C Overdose Company Paranoia Representative Pulmonary Congestion Other Pulmonary Oedema Date:04/03/01ISR Number: 3695921-1Report Type:Expedited (15-DaCompany Report #EWC010325772 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Therapeutic Health Mania Professional Other Date:04/03/01ISR Number: 3695924-7Report Type:Expedited (15-DaCompany Report #DE_010104555 Age:31 YR Gender:Male I/FU:F Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Non-Insulin-Dependent Drug Interaction 24-Jun-2005 12:19 PM Page: 1358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fat Tissue Increased Hyperlipidaemia Hypertriglyceridaemia Report Source Product Role Manufacturer Route Dose Duration Pancreatitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Leponex (Clozapine) C Professional Seroxat (Paroxetine Other Hydrochloride) C Pirenzepine C Date:04/03/01ISR Number: 3695927-2Report Type:Expedited (15-DaCompany Report #DE_001204153 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arterial Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Compartment Syndrome Health Stilnox (Zolpidem) C Initial or Prolonged Diplopia Professional Kliogest C Renal Impairment Other Rhabdomyolysis Tachycardia Date:04/03/01ISR Number: 3695931-4Report Type:Expedited (15-DaCompany Report #DE_001203872 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Cardiac Failure Health Paroxetin Congestive Professional (Paroxetine) C Cyanosis Other Promethazine C Dyspnoea Novodigal (Digoxin) C Myocarditis Oedema Peripheral Pulmonary Congestion Date:04/03/01ISR Number: 3695934-XReport Type:Expedited (15-DaCompany Report #CA_010303362 Age:4 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Induced Foreign Zyprexa PS Eli Lilly And Co 124 DAY Arnold-Chiari Health Clonazepam C Malformation Professional Paxil (Paroxetine Complications Of Maternal Company Hydrochloride) C Exposure To Therapeutic Representative Drugs Other Congenital Hydrocephalus Meningocele Spina Bifida Date:04/03/01ISR Number: 3695956-9Report Type:Expedited (15-DaCompany Report #DE_000802838 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Alkaline Initial or Prolonged Phosphatase Increased Disability Blood Pressure Increased Cognitive Disorder Depressed Level Of Consciousness 24-Jun-2005 12:19 PM Page: 1359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Coma Disturbance In Attention Gamma-Glutamyltransferase Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Hallucination Literature Quilonum - Slow Hallucinations, Mixed Health Release (Lithium Lethargy Professional Carbonate) C Liver Disorder Other Anafranil Malaise (Clomipramine Mental Disorder Due To A Hydrochloride) C General Medical Condition Paraesthesia Pneumonia Renal Failure Acute Rhabdomyolysis Thirst Visual Disturbance Date:04/03/01ISR Number: 3696338-6Report Type:Expedited (15-DaCompany Report #US_010362407 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Increased Professional Blood Pressure Medication C Date:04/03/01ISR Number: 3696344-1Report Type:Expedited (15-DaCompany Report #US_010362177 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY First Degree Professional Cardiomegaly Date:04/03/01ISR Number: 3696375-1Report Type:Expedited (15-DaCompany Report #US_010361942 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Consumer Insulin-Insulin-Anim Initial or Prolonged Hyperhidrosis al (Unknown Transplant Rejection Formulation) (Insulin, Animal) PS Eli Lilly And Co Humulin-Human Insulin (Rdna): 30% Regular, 70% Nph (Human Insulin (Rdna Origin)) SS 35 U/2 DAY Humalog-, (Lispro) SS Zyprexa (Olanzapine) SS Adalat (Nifedipine) C Aspirin C Atenolol C Bactrim C Claritin (Loratadine) C Clonidine C Colace (Docusate Sodium) C 24-Jun-2005 12:19 PM Page: 1360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prednisone C Prilosec (Omeprazole) C Minoxidil C Ketoconazole C Terazosin C Date:04/03/01ISR Number: 3696566-XReport Type:Expedited (15-DaCompany Report #A104039 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Foreign Zoloft Tablets PS Pfizer Intervention to Overdose Health Pharmaceuticals Inc ORAL ORAL Prevent Permanent Restlessness Professional Olanzapine SS Impairment/Damage Sedation Other Tachycardia Tremor Date:04/03/01ISR Number: 3696582-8Report Type:Expedited (15-DaCompany Report #DE_010305367 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Lymphopenia Health Tavor (Lorazepam) C Professional Ergenyl Chrono C Other Carbamazepine C Priorin C Eunerpan (Melperone Hydrochloride) C Cipramil (Citalopram Hydrobromide) C L-Thyroxin (Levothyroxine Sodium) C Date:04/03/01ISR Number: 3696585-3Report Type:Expedited (15-DaCompany Report #AU_010303220 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Professional Other Date:04/03/01ISR Number: 3696597-XReport Type:Expedited (15-DaCompany Report #AU_010303222 Age:40 YR Gender:Female I/FU:I Outcome PT Life-Threatening Confusional State Hospitalization - Dyspnoea Initial or Prolonged Faecal Incontinence Hypercapnia Pco2 Increased Pneumonia Po2 Decreased Respiratory Disorder Respiratory Failure 24-Jun-2005 12:19 PM Page: 1361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Sleep Apnoea Syndrome Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 20 MG/IN THE Health EVENING Professional Lithium Carbonate C Other Valproate Sodium C Venlafaxine C Date:04/03/01ISR Number: 3696609-3Report Type:Expedited (15-DaCompany Report #DE_010305363 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Sodium Decreased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Grand Mal Convulsion Health Lasix (Furosemide) C Initial or Prolonged Inappropriate Professional Antidiuretic Hormone Other Secretion Date:04/03/01ISR Number: 3696625-1Report Type:Expedited (15-DaCompany Report #DE_010305366 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Phosphokinase Increased Health Rhabdomyolysis Professional Date:04/03/01ISR Number: 3696631-7Report Type:Expedited (15-DaCompany Report #EWC010326007 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Overdose Health Stilnox C Professional Date:04/03/01ISR Number: 3696634-2Report Type:Expedited (15-DaCompany Report #EWC010326024 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Chondromatosis Foreign Zyprexa PS Eli Lilly And Co 6 MON Complications Of Maternal Health Tranxene C Exposure To Therapeutic Professional Drugs Congenital Anomaly Foetal Distress Syndrome Date:04/04/01ISR Number: 3695181-1Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Zyprexa (Olanzapine) Intervention to Inadequate Control (10mg -Lilly) PS Lilly 20MG @HS Prevent Permanent Insulin Human 70/30 C Impairment/Damage 24-Jun-2005 12:19 PM Page: 1362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/01ISR Number: 3696956-5Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Zyprexa Hospitalization - Diabetes Mellitus (Olanzapine), (Eli Initial or Prolonged Diabetic Ketoacidosis Lilly) PS El Lilly ORAL 10MG ONCE Required Hypoglycaemia DAILY PO 15MG Intervention to Polydipsia ONCE DAILY PO Prevent Permanent Urinary Incontinence Valproic Acid C Impairment/Damage Vomiting Date:04/05/01ISR Number: 3698673-4Report Type:Direct Company Report #USP 53890 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zydis PS Scherer Zyprexa Zydis SS Lilly Date:04/06/01ISR Number: 3700113-3Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Delirium Olanzapine PS Date:04/06/01ISR Number: 3700172-8Report Type:Expedited (15-DaCompany Report #LBID00201001421 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Literature Lithobid PS Solvay Initial or Prolonged Decreased Health Pharmaceuticals ORAL 1200 MG DAILY Blood Urea Increased Professional PO 1200 MG Drug Level Above DAILY PO Therapeutic Clonazepam Hypothermia (Clonazepam) SS ORAL 1 MG QD PO Lethargy Olanzapine SS ORAL 5 MG QD PO Mental Impairment Piroxicam Oedema Peripheral (Piroxicam) C Oral Intake Reduced Trazodone Platelet Count Decreased Hydrochloride (Trazodone Hydrochloride) C Lactulose (Lactulose) C Sulfamethoxazole (Sulfamethoxazole) C Trimethoprim (Trimethoprim) C Date:04/08/01ISR Number: 3707348-4Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Olanzapine PS ORAL 15 MG AM 10 Neuroleptic Malignant MG PM PO 2 YR Syndrome 24-Jun-2005 12:19 PM Page: 1363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/01ISR Number: 3699947-3Report Type:Expedited (15-DaCompany Report #B0070412A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Consumer Azantac PS Glaxo Wellcome ORAL Hospitalization - Rash Maculo-Papular Sodium Valproate SS ORAL Initial or Prolonged Toxic Epidermal Carbamazepine SS ORAL 7 DAY Necrolysis Cyamemazine SS ORAL Zyprexa SS ORAL Zolpidem SS ORAL Date:04/09/01ISR Number: 3699980-1Report Type:Expedited (15-DaCompany Report #A0141730A Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Lamictal PS Glaxo Wellcome ORAL 200MG Per day YR Initial or Prolonged Agitation Carafate SS Other Arthralgia Dilantin SS 500MG Per day Blood Pressure Increased Zyprexa SS Chest Pain Prevacid C Convulsion Pepcid C Drug Level Above Therapeutic Fall Hypoaesthesia Insomnia Nervous System Disorder Petechiae Psychotic Disorder Speech Disorder Swelling Vomiting Date:04/09/01ISR Number: 3700936-0Report Type:Expedited (15-DaCompany Report #DE_010305433 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Decreased Other Cotrim C Exelon (Rivastigmine Tartrate) C Nacom C Cipramil (Citalopram Hydrobromide) C Almirid (Dihydroergocryptine Mesilate) C Ass 100 "Ct-Arzneimittel" (Acetylsalicylic Acid) C Distraneurin (Clomethiazole Edisilate) C Glucophag (Metformin Hydrochloride) C Euglucon (Glibenclamide) C 24-Jun-2005 12:19 PM Page: 1364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/01ISR Number: 3700939-6Report Type:Expedited (15-DaCompany Report #EWC000506767 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Caesarean Section Health Complications Of Maternal Professional Exposure To Therapeutic Drugs Eclampsia Postpartum Disorder Pregnancy Premature Baby Schizophrenia Date:04/09/01ISR Number: 3700941-4Report Type:Expedited (15-DaCompany Report #EWC010426223 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Rivotril Professional (Clonazepam) C Company Seroxat (Paroxetine Representative Hydrochloride) C Laevolac (Lactulose) C Date:04/09/01ISR Number: 3700942-6Report Type:Expedited (15-DaCompany Report #DE_010305398 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Hepatitis Health Aricept (Donepezil Jaundice Professional Hydrochloride) C Date:04/09/01ISR Number: 3700944-XReport Type:Expedited (15-DaCompany Report #CA_010303431 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Biopsy Lymph Gland Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Abnormal Health Elavil Breast Cancer Female Professional (Amitriptyline Liver Function Test Hydrochloride) C Abnormal Lithium C Neoplasm Date:04/09/01ISR Number: 3701002-0Report Type:Expedited (15-DaCompany Report #A0141730A Age:25 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Agitation Required Arthralgia Intervention to Blood Pressure Increased Prevent Permanent Brain Scan Abnormal Impairment/Damage Brief Psychotic Disorder Without Marked Stressors Chest Pain Convulsion 24-Jun-2005 12:19 PM Page: 1365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Above Therapeutic Fall Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Health Lamictal PS Glaxo Wellcome Inc ORAL 200 MG / PER Imprisonment Professional DAY / ORAL Injury Sucralfate Insomnia (Sucralfate) SS Neck Pain Phenytoin Nervous System Disorder (Phenytoin) SS 500 MG / PER Petechiae DAY Psychotic Disorder Olanzapine Speech Disorder (Olanzapine) SS Vomiting Lansoprazole C Famotidine C Date:04/09/01ISR Number: 3701022-6Report Type:Expedited (15-DaCompany Report #DE_010305408 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Circulatory Collapse Health Anafranil Fall Professional (Clomipramine Haemorrhage Other Hydrochloride) C Head Injury Valium (Diazepam) C Headache Tavor (Lorazepam) C Insomnia Heparin C Loss Of Consciousness Skull Fractured Base Date:04/09/01ISR Number: 3701024-XReport Type:Expedited (15-DaCompany Report #DE_010305400 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY 7 WK Initial or Prolonged Decreased Health Dizziness Professional Gait Disturbance Other Malaise Date:04/09/01ISR Number: 3701045-7Report Type:Expedited (15-DaCompany Report #IL98021159A Age:34 YR Gender:Male I/FU:I Outcome PT Life-Threatening Apnoea Hospitalization - Aspartate Initial or Prolonged Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Lactate Dehydrogenase Increased Cardiomegaly Clostridium Colitis Dermatitis Dermatitis Exfoliative Diarrhoea Drug Hypersensitivity 24-Jun-2005 12:19 PM Page: 1366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Eosinophilia Eyelid Oedema Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Increased Literature Carbamazepine C Haemolytic Anaemia Health Haldol (Haloperidol) C Heart Rate Irregular Professional Valium (Diazepam C Hepatic Enzyme Increased Other Quinidine C Hepatic Necrosis Clonazepam C Hepatitis Lymphadenopathy Periorbital Oedema Pneumonia Pruritus Pyrexia Respiratory Failure Upper Respiratory Tract Infection Urticaria Date:04/09/01ISR Number: 3701131-1Report Type:Direct Company Report # Age:64 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Zyprexa PS ORAL PO Hospitalization - Dialysis Valproic Acid C Initial or Prolonged Metabolic Acidosis Verapamil C Required Muscle Rigidity Lasix C Intervention to Neuroleptic Malignant Paxil C Prevent Permanent Syndrome Zantac C Impairment/Damage Renal Failure Acute Date:04/09/01ISR Number: 3701163-3Report Type:Expedited (15-DaCompany Report #US_010362821 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspiration Health Zyprexa PS Eli Lilly And Co 5 MG/2 DAY 30 MON Paralysis Professional Colace (Docusate Sodium) C Date:04/09/01ISR Number: 3701170-0Report Type:Expedited (15-DaCompany Report #US_010362876 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Zyprexa PS Eli Lilly And Co Overdose Date:04/09/01ISR Number: 3701360-7Report Type:Expedited (15-DaCompany Report #US_010362337 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 1367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/01ISR Number: 3701361-9Report Type:Expedited (15-DaCompany Report #US_010362485 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Zyprexa PS Eli Lilly And Co 40 MG/1 AT Diabetes Mellitus Professional BEDTIME Clonazepam C Topiramate C Levothyroxine C Ciprofloxacin C Phenazopyridine C Date:04/09/01ISR Number: 3701515-1Report Type:Expedited (15-DaCompany Report #B0070412A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Zantac 150 PS Glaxo Wellcome Inc ORAL ORAL Hospitalization - Rash Generalised Valproate Sodium SS ORAL ORAL Initial or Prolonged Rash Maculo-Papular Carbamazepine SS ORAL ORAL Toxic Epidermal Cyamemazine SS ORAL ORAL Necrolysis Olanzapine SS ORAL ORAL Zolpidem SS ORAL ORAL Date:04/09/01ISR Number: 3701518-7Report Type:Expedited (15-DaCompany Report #EWC010326171 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Hepatitis Health Hypothermia Professional Lymphopenia Other Neutropenia Pneumonia Thrombocytopenia Date:04/09/01ISR Number: 3701623-5Report Type:Expedited (15-DaCompany Report #EWC010326136 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ultrasound Scan Abnormal Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Urinary Retention Health Urinary Tract Disorder Professional Other Date:04/10/01ISR Number: 3702330-5Report Type:Expedited (15-DaCompany Report #US_000134612 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Literature Zyprexa PS Eli Lilly And Co 25 MG DAY Initial or Prolonged Diabetic Hyperosmolar Health Gabapentin C Other Coma Professional Isordil (Isosorbide Glycosylated Haemoglobin Dinitrate) C Increased Prevacid Hallucination (Lansoprazole) C Pneumonia Lopressor Polydipsia (Metoprolol Polyuria Tartrate) C Venlafaxine C 24-Jun-2005 12:19 PM Page: 1368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/01ISR Number: 3702338-XReport Type:Expedited (15-DaCompany Report #US_010361329 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Zyprexa PS Eli Lilly And Co 20 MG/1 AT Professional BEDTIME 45 WK Date:04/10/01ISR Number: 3702343-3Report Type:Expedited (15-DaCompany Report #US_010259319 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa PS Eli Lilly And Co 2 WK Hospitalization - Loss Of Consciousness Professional Lithium C Initial or Prolonged Pollakiuria Company Carbamazepine C Other Pulmonary Embolism Representative Thirst Date:04/10/01ISR Number: 3702872-2Report Type:Expedited (15-DaCompany Report #EWC010225626 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Increased Health Rhabdomyolysis Professional Sedation Other Date:04/10/01ISR Number: 3702874-6Report Type:Expedited (15-DaCompany Report #CA_010103029 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Activity Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Deep Vein Thrombosis Health Elavil Depression Professional (Amitriptyline Company Hydrochloride) C Representative Tegretol Other (Carbamazepine) C Duralith (Lithium Carbonate) C Date:04/10/01ISR Number: 3703611-1Report Type:Expedited (15-DaCompany Report #002-0945-M0100045 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Neurontin PS Parke Davis Drug Level Above Health Pharmaceuticals Ltd ORAL PER ORAL Therapeutic Professional Zyprexia (Olanzapine) SS Hydromorphone(Hydrom orphone) SS Date:04/11/01ISR Number: 3703104-1Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Dysarthria Hyperphagia 24-Jun-2005 12:19 PM Page: 1369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Appetite Polydipsia Polyuria Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Olanzapine-Zyprexa- 10 Mg Eli Lilly PS Eli Lilly ORAL 30MG HS ORAL Risperdal C Depakote C Date:04/11/01ISR Number: 3703248-4Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Zyprexa (10mg) (Eli Initial or Prolonged Willy) PS Eli Willy 1 DAILY Lorazepam C Wellbutrin C Zoloft C Date:04/11/01ISR Number: 3703280-0Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa (Olanzapine) 10mg (Tablet) PS ORAL 20MG HS PO 30MG HS Haloperidol Decanoate C Divalproex Sodium C Date:04/11/01ISR Number: 3703282-4Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa (Olanzapine) 5mg & 10mg Tablets PS ORAL 15MG HS PO Combivent Inhaler C Diltiazem Er C Docusate Calcium C Flovent Inhaler C Hydroxyzine Hcl C K-Dur C Lanoxin C Pepcid C Vasotec C Tetracycline C Date:04/12/01ISR Number: 3703893-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Zyprexa "Olanzapine" Muscle Rigidity 2.5 Mg Eli Lilly PS Eli Lilly ORAL 2.5 MG BID Neuroleptic Malignant ORAL Syndrome Risperdol Pyrexia "Risperidal" SS ORAL 0.5 MG BID ORAL 24-Jun-2005 12:19 PM Page: 1370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/01ISR Number: 3704382-5Report Type:Direct Company Report # Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Mirapex 0.25mg PS ORAL 2 PO TID Initial or Prolonged Delirium Zyprexa 2.5mg SS ORAL 1 PO QHS Sedation Ecasa X C Vasotec C Plavix C Lasix C Digoxin C Lopressor C Celebrex C Date:04/15/01ISR Number: 3723900-4Report Type:Expedited (15-DaCompany Report #GBS010408660 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Health Professional Other Date:04/16/01ISR Number: 3705553-4Report Type:Expedited (15-DaCompany Report #US_010259832 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co 20 MG/IN THE Initial or Prolonged Corrected Interval Professional EVENING Prolonged Thorazine Oxygen Saturation (Chlopromazine Decreased Hydrochloride) C Remeron (Mirtazapine) C Lorazepam C Lithium C Date:04/16/01ISR Number: 3705555-8Report Type:Expedited (15-DaCompany Report #US_010361896 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Hospitalization - Corrected Interval Professional BEDTIME Initial or Prolonged Prolonged Plavix (Clopidogrel Electrocardiogram Qt Sulfate) C Prolonged Metoprolol C Phaeochromocytoma Pepcid (Famotidine) C Torsade De Pointes Wellbutrin (Amfebutamone Hydrochloride) C Aspirin C Enoxaparin C Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 1371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/01ISR Number: 3705578-9Report Type:Expedited (15-DaCompany Report #US_010260539 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS Eli Lilly And Co 5 MG/DAY 7 MON Decreased Professional Paxil (Paroxetine Company Hydrochloride) C Representative Klonopin (Clonazepam) C Norpramin (Desipramine Hydrochloride) C Date:04/16/01ISR Number: 3706024-1Report Type:Expedited (15-DaCompany Report #EWC010225406 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Purpura Health Professional Date:04/16/01ISR Number: 3706030-7Report Type:Expedited (15-DaCompany Report #DE_010305366 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Haldol (Haloperidol) C Professional Neurocil (Levomepromazine Maleate) C Akineton Retard (Biperiden Hydrochloride) C Date:04/16/01ISR Number: 3706052-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU03611 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Muscle Rigidity Foreign Exelon PS Novartis Neuroleptic Malignant Health Pharmaceuticals Corp 1.5 MG, BID Syndrome Professional Zyprexa (Olanzapine) SS 5 MG, QD Other Aricept (Donepezil Hydrochloride) SS 10 MG/D Prednisolone C Date:04/16/01ISR Number: 3706197-0Report Type:Expedited (15-DaCompany Report #EWC001108595 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Duodenal Ulcer Health Glucophage Gastritis Professional (Metformin Hepatic Steatosis Company Hydrochloride) C Oesophagitis Representative Pancreatitis Acute Other Scar 24-Jun-2005 12:19 PM Page: 1372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/01ISR Number: 3707007-8Report Type:Expedited (15-DaCompany Report #EWC010426240 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Hepatic Function Abnormal Health Eltroxin Pyrexia Professional (Levothyroxine Other Sodium) C Litarex (Lithium Citrate) C Optimol (Timolol Maleate) C Remeron (Mirtazapine) C Date:04/17/01ISR Number: 3707008-XReport Type:Expedited (15-DaCompany Report #EWC010426265 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa PS Eli Lilly And Co 35 MG Health Professional Other Date:04/17/01ISR Number: 3707011-XReport Type:Expedited (15-DaCompany Report #GBS010408579 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Initial or Prolonged Mental Impairment Health Professional Other Date:04/17/01ISR Number: 3707012-1Report Type:Expedited (15-DaCompany Report #EWC010426243 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa PS Eli Lilly And Co 10 MG Initial or Prolonged Haemodialysis Health Zoloft (Sertraline Renal Tubular Necrosis Professional Hydrochloride) C Rhabdomyolysis Other Date:04/17/01ISR Number: 3707065-0Report Type:Expedited (15-DaCompany Report #US_010463418 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Health Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Increased Professional Blood Triglycerides Company Increased Representative Haematuria Hepatic Steatosis Prostatitis Urinary Incontinence Weight Increased 24-Jun-2005 12:19 PM Page: 1373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/01ISR Number: 3707066-2Report Type:Expedited (15-DaCompany Report #US_010463196 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Decreased Activity Consumer Zyprexa PS Eli Lilly And Co Diarrhoea Difficulty In Walking Fluid Retention Paralysis Rash Pruritic Date:04/17/01ISR Number: 3707069-8Report Type:Expedited (15-DaCompany Report #US_010463327 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Zyprexa PS Eli Lilly And Co 20 MG/1 AT Diabetes Mellitus Professional BEDTIME 4 YR Insulin-Dependent Paxil (Paroxetine Dysphagia Hydrochloride) C Epiglottitis Ambien (Zolpidem Head Injury Tartrate) C Nasopharyngeal Disorder Depakote (Valproate Oesophageal Disorder Semisodium) C Respiratory Arrest Depakene (Valproate Respiratory Distress Sodium) C Norvasc (Amlodipine Besilate) C Hydrochlorothiazide/ Triamterene C Prevacid (Lansoprazole) C Date:04/17/01ISR Number: 3707071-6Report Type:Expedited (15-DaCompany Report #US_010463374 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa Professional (Olanzapine) PS Eli Lilly And Co Date:04/17/01ISR Number: 3707096-0Report Type:Expedited (15-DaCompany Report #PHBS2000AU06115 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Foreign Anafranil PS Novartis Bladder Disorder Health Pharmaceuticals Corp ORAL ORAL Catatonia Professional Zyprexa (Olanzapine) Constipation Other Unknown SS 5 MG/DAY Dystonia Parkinson'S Disease Pollakiuria Date:04/19/01ISR Number: 3707921-3Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required 24-Jun-2005 12:19 PM Page: 1374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Zyprexa 50 Mg PS ORAL 50MG ORAL Dystonia Hypertension Irritability Date:04/19/01ISR Number: 3708980-4Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Priapism Zyprexa PS SEE IMAGE Date:04/24/01ISR Number: 3710015-4Report Type:Expedited (15-DaCompany Report #US_010157495 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Zyprexa PS Eli Lilly And Co 6 DSG FORM Initial or Prolonged Asthma Health Placebo SS 3 DSG FORM/AT Blood Glucose Increased Professional BEDTIME Condition Aggravated Trazodone C Deep Vein Thrombosis Albuterol C Diabetes Mellitus Ipratropium C Diabetic Ketoacidosis Cetirizine C Pulmonary Embolism Fluticasone C Sinusitis Montelukast C Amoxicillin C Haldol (Haloperidol) C Lansoprazole C Combivent C Colace (Docusate Sodium) C Ferrous Sulfate C K-Dur (Potassium Chloride) C Prednisone C Flexeril (Cyclobenzaprine Hydrochloride) C Ascorbic Acid C Date:04/24/01ISR Number: 3710016-6Report Type:Expedited (15-DaCompany Report #US_010463641 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY White Blood Cell Count Professional Prozac (Fluoxetine Decreased Company Hydrochloride) SS Representative Date:04/24/01ISR Number: 3710647-3Report Type:Expedited (15-DaCompany Report #US_010156893 Age:63 YR Gender:Male I/FU:F Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 1375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY Agitation Health Fluvoxamine C Arteriosclerosis Professional Depakote(Valproate Bronchopneumonia Semisodium) C Coordination Abnormal Clonazepam C Difficulty In Walking Thiamine C Diverticulum Cozaar (Losartan Emphysema Potassium) C Flushing Vioxx (Rorecoxib) C Hallucination, Auditory Pravachol Insomnia (Pravastatin Sodium) C Lethargy Cogentin Neuroleptic Malignant (Benzatropine Syndrome Mesilate) C Paranoia Coumadin (Warfarin Pneumonia Sodium) C Rhabdomyolysis Prednisone C Sedation Methotrexate C Date:04/24/01ISR Number: 3710650-3Report Type:Expedited (15-DaCompany Report #US_010260735 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Zyprexa PS Eli Lilly And Co 5 MG/DAY Sedation Depakote (Valproate Thirst Semisodium) C Cogentin (Benzatropine Mesilate) C Prosom (Estazolam) C Date:04/24/01ISR Number: 3710651-5Report Type:Expedited (15-DaCompany Report #US_000848466 Age:38 YR Gender:Male I/FU:F Outcome PT Death Accidental Overdose Blood Potassium Increased Brain Oedema Bronchitis Chronic Cardiac Disorder Coordination Abnormal Drug Toxicity Ecchymosis Fibrosis Gait Disturbance Hepatic Congestion Inflammation Laceration Muscle Hypertrophy Nervous System Disorder Oedema Peripheral Pancreatic Disorder Pancreatic Haemorrhage Pulmonary Oedema Renal Disorder Skin Discolouration 24-Jun-2005 12:19 PM Page: 1376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Staphylococcal Infection Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Health Fluoxetine Hcl PS Lilly Research Professional Laboratories Div Eli Lilly And Co 40 MG/2 DAY Zyprexa (Olanzapine) SS 40 MG/DAY Mellaril (Thioridazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Ferrous Sulfate C Symmetrel (Amantadine Hydrochloride) C Hytrin (Terazosin Hydrochloride) C Seroquel C Date:04/24/01ISR Number: 3710816-2Report Type:Expedited (15-DaCompany Report #US_010463374 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 5 MG/3 DAY Initial or Prolonged Phosphokinase Increased Professional Clozaril (Clozapine) C Mania Company Depakote (Valproate Pyrexia Representative Semisodium) C Schizophrenia Sedation Date:04/24/01ISR Number: 3710818-6Report Type:Expedited (15-DaCompany Report #US_010361575 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Haematocrit Decreased Professional Asa (Acetylsalicylic Haemoglobin Decreased Company Acid) C International Normalised Representative Multivitamin C Ratio Decreased Prothrombin Time Shortened Date:04/24/01ISR Number: 3710828-9Report Type:Expedited (15-DaCompany Report #US_010259458 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Hospitalization - Faeces Discoloured Professional BEDTIME A FEW Initial or Prolonged Haematochezia MONTHS Other Renal Neoplasm Prozac (Fluoxetine Hydrochloride) SS 20 MG/DAY A FEW MONTHS Lithium C Trazodone C Atenolol C K-Dur (Potassium 24-Jun-2005 12:19 PM Page: 1377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chloride) C Synthroid (Levothyroxine Sodium) C Date:04/24/01ISR Number: 3710832-0Report Type:Expedited (15-DaCompany Report #US_010463552 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Health Zyprexa (Olanzapine) PS Eli Lilly And Co Professional Date:04/24/01ISR Number: 3710856-3Report Type:Expedited (15-DaCompany Report #EWC010125031 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS Eli Lilly And Co 22.5 MG DAY Toxic Epidermal Health Rivotril Necrolysis Professional (Clonazepam) C Other Tegretol (Carbamazepine) C Date:04/24/01ISR Number: 3710865-4Report Type:Expedited (15-DaCompany Report #EWC010326136 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bladder Disorder Foreign Zyprexa PS Eli Lilly And Co 2.5 MG DAY Hypertonic Bladder Health Urinary Retention Professional Other Date:04/24/01ISR Number: 3711172-6Report Type:Expedited (15-DaCompany Report #EWC010426340 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Biperiden C Professional Zuclopenthixol Decanoate C INTRAMUSCULAR 200 MG/EVERY OTHER WEEK Date:04/24/01ISR Number: 3711190-8Report Type:Expedited (15-DaCompany Report #EWC010426329 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Malaise Health Pancreatitis Acute Professional Vomiting Company Representative 24-Jun-2005 12:19 PM Page: 1378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/01ISR Number: 3711191-XReport Type:Expedited (15-DaCompany Report #EWC010426331 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Muscle Spasms Health Rivotril C Vomiting Professional Company Representative Date:04/24/01ISR Number: 3711193-3Report Type:Expedited (15-DaCompany Report #GBS010408612 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa PS Eli Lilly And Co 60 MG/ IN THE Initial or Prolonged Health EVENING Professional Carbamazepine C Date:04/24/01ISR Number: 3711350-6Report Type:Expedited (15-DaCompany Report #DE_010305363 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Hospitalization - Grand Mal Convulsion Health Initial or Prolonged Hypokalaemia Professional Hyponatraemia Other Inappropriate Antidiuretic Hormone Secretion Pneumonia Aspiration Pyrexia Sedation Urinary Tract Infection Date:04/24/01ISR Number: 3711351-8Report Type:Expedited (15-DaCompany Report #EWC001108712 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Other Retinal Vein Thrombosis Health Professional Other Date:04/25/01ISR Number: 3710668-0Report Type:Expedited (15-DaCompany Report #C2001-0972.01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Literature Clonazepam PS Mylan Initial or Prolonged Decreased Activity Other Pharmaceuticals Inc ORAL 1 MG QD, ORAL Depressed Level Of Lithium SS ORAL 300 MG BID Consciousness AND 600 MG Hyperreflexia QHS, ORAL Hypothermia Olanzapine Lilly SS Lilly ORAL 5 MG QD, ORAL Lethargy Piroxicam C Mental Impairment Sulfamethoxazole/Tri Oedema Peripheral methoprim C Oral Intake Reduced Social Avoidant Behaviour 24-Jun-2005 12:19 PM Page: 1379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/01ISR Number: 3710738-7Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Flushing Olanzapine PS ORAL 20 MG / DAY Initial or Prolonged Headache PO Required Rhabdomyolysis Valproic Acid SS 1000 MG BID 76 MON Intervention to Lithium Co3 C Prevent Permanent Depakote C Impairment/Damage Clonazapine C Date:04/25/01ISR Number: 3711175-1Report Type:Expedited (15-DaCompany Report #A014542 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Zoloft PS Pfizer Initial or Prolonged Suicidal Ideation Health Pharmaceuticals Inc ORAL 50.00 MG Required Professional TOTAL: DAILY: Intervention to ORAL Prevent Permanent Zyprexa SS Impairment/Damage Rivotril C Nolvadex C Depakine Chrono C Levothyrox C Date:04/27/01ISR Number: 3712909-2Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olanzapine PS ORAL 15MG,5MG QAM Hospitalization - Syndrome ORAL Initial or Prolonged Cephalexin (Keflex) C Required Nifedipine Cc Intervention to (Adalat Cc) C Prevent Permanent Divalproex Impairment/Damage (Depakote) C Lithium Carbonate C Olanzapine (Zyprexa) C Trazodone (Desyrel) C Docusate Sod (Colace) C Haloperidol C Metoprolol C Methyldopate C Levofloxacin (Levaquin) C Ranitidine (Zantac) C Date:04/27/01ISR Number: 3713110-9Report Type:Expedited (15-DaCompany Report #PHBS2000FI08467 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agranulocytosis Initial or Prolonged Blood Creatinine Increased Blood Lactate Dehydrogenase Increased C-Reactive Protein Increased 24-Jun-2005 12:19 PM Page: 1380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coombs Direct Test Positive Haemolysis Report Source Product Role Manufacturer Route Dose Duration Infection Foreign Clozaril PS Novartis Leukopenia Health Pharmaceuticals Corp ORAL 350MG/D, ORAL Neutropenia Professional Zyprexa(Olanzapine) SS 47 DAY Pyrexia Other Haloperin C Renal Impairment Opamox (Oxazepam) C Imovane C Burana C Date:04/30/01ISR Number: 3713852-5Report Type:Expedited (15-DaCompany Report #US_010362253 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Prozac PS Lilly Research Initial or Prolonged Increased Professional Laboratories Div Eli Aspartate Lilly And Co 60 MG/DAY 2 YR Aminotransferase Zyprexa (Olanzapine) SS 10 MG/DAY 4 MON Increased Cogentin Condition Aggravated (Benzatropine Schizophrenia Mesilate) C Buspar (Buspirone Hydrochloride) C Coenzyme C Serzone (Nefazodone Hydrochloride) C Date:04/30/01ISR Number: 3713891-4Report Type:Expedited (15-DaCompany Report #US_010464116 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY Face Oedema Levothyroxine C Hypersensitivity Obstructive Airways Disorder Pruritus Tongue Oedema Date:04/30/01ISR Number: 3713894-XReport Type:Expedited (15-DaCompany Report #US_010464002 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Health Zyprexa PS Eli Lilly And Co 80 MG/DAY 3 DAY Professional Seroquel (Paroxetine Hydrochloride) C Date:04/30/01ISR Number: 3713895-1Report Type:Expedited (15-DaCompany Report #AU_001002122 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Insomnia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Hospitalization - Mania Study Betamin (3- Initial or Prolonged Promiscuity Health (5-Amino-2, Sexual Inhibition Professional 4-Diidophenyl) Other -Alanin) C 24-Jun-2005 12:19 PM Page: 1381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithicarb (Lithium Carbonate) C Uremide (Furosemide) C Cogentin (Benzatropine Mesilate) C Cardiprin (Acetylsalicylic Acid) C Slow-K (Potassium Chloride) C Slow-K (Potassium Chloride) C Paxam (Piroxicam) C Date:04/30/01ISR Number: 3713896-3Report Type:Expedited (15-DaCompany Report #US_010463979 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS Eli Lilly And Co 15 MG/DAY 3 MON White Blood Cell Count Professional Depakote (Valproate Decreased Semisodium) C Serzone (Nefazodone Hydrochloride) C Celebrex (Celecoxib) C Date:04/30/01ISR Number: 3713897-5Report Type:Expedited (15-DaCompany Report #US_010464089 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Paxil (Paroxetine Company Hydrochloride) C Representative Ritalin (Methylphenidate Hydrochloride) C Date:04/30/01ISR Number: 3713899-9Report Type:Expedited (15-DaCompany Report #EWC010426340 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Biperiden C Professional Zuclopenthixol Other Decanoate C Date:04/30/01ISR Number: 3713901-4Report Type:Expedited (15-DaCompany Report #US_010361816 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Maculopathy Health Zyprexa PS Eli Lilly And Co Pigmentation Disorder Professional Zestril (Lisinopril) C Retinal Disorder Lanoxin (Digoxin) C Visual Acuity Reduced Wellbutrin (Amfebutamone Hydrochloride) C Prilosec 24-Jun-2005 12:19 PM Page: 1382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Omeprazole) C Ddavp (Desmopressin) C Detrol (Tolterodine L-Tartrate) C Clonazepam C Meclizine C Date:04/30/01ISR Number: 3713905-1Report Type:Expedited (15-DaCompany Report #US_010362177 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Zyprexa PS Eli Lilly And Co 2.5 MG/2 DAY First Degree Professional Cardiomegaly Date:04/30/01ISR Number: 3713931-2Report Type:Expedited (15-DaCompany Report #US_010362337 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Zyprexa PS Eli Lilly And Co Completed Suicide Professional Drug Toxicity Pulmonary Oedema Date:04/30/01ISR Number: 3713938-5Report Type:Expedited (15-DaCompany Report #US_991029297 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Literature Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Aminotransferase Health Bactrim C Other Increased Professional Lithium C Blood Pressure Diastolic Trazodone C Decreased Piroxicam C Coma Clonazepam C Constipation Lactulose C Decreased Activity Trimethoprim C Depressed Level Of Consciousness Hypothermia Lethargy Mental Impairment Muscle Rigidity Oedema Peripheral Oral Intake Reduced Social Avoidant Behaviour Date:04/30/01ISR Number: 3713941-5Report Type:Expedited (15-DaCompany Report #US_010260442 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Other Injury Professional Haldol (Haloperidol) C Company Congetin Representative (Benzatropine Mesilate) C 24-Jun-2005 12:19 PM Page: 1383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/01ISR Number: 3713955-5Report Type:Expedited (15-DaCompany Report #US_010260172 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Zyprexa PS Eli Lilly And Co 15 MG/DAY 1 YR Life-Threatening Haemorrhage Professional Hospitalization - Hallucination Company Initial or Prolonged Pneumonia Representative Other Respiratory Failure Date:04/30/01ISR Number: 3713965-8Report Type:Expedited (15-DaCompany Report #US_010464115 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colorectal Cancer Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Depression Literature Health Professional Other Date:04/30/01ISR Number: 3714285-8Report Type:Expedited (15-DaCompany Report #US_010463899 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Deficit/Hyperactivity Literature Disorder Health Delusion Of Grandeur Professional Drug Withdrawal Syndrome Mania Date:04/30/01ISR Number: 3714286-XReport Type:Expedited (15-DaCompany Report #US_010463929 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Foreign Zyprexa PS Eli Lilly And Co 25 MG/1 DAY Hallucination, Auditory Literature Persecutory Delusion Health Psychotic Disorder Professional Schizophrenia Date:04/30/01ISR Number: 3714299-8Report Type:Expedited (15-DaCompany Report #EWC010426475 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Anaemia Health Lexomil (Bromazepam) C Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 1384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/01ISR Number: 3714300-1Report Type:Expedited (15-DaCompany Report #GBS010408597 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Extrapyramidal Disorder Health Carbamazepine C Leukopenia Professional Clomipramine C Neutrophil Count Other Benztropine C Decreased Modecate Physical Assault (Fluphenazine Platelet Count Decreased Decanoate) C Thiordiazine C Date:04/30/01ISR Number: 3714303-7Report Type:Expedited (15-DaCompany Report #GBS010408660 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co Health Professional Other Date:04/30/01ISR Number: 3714307-4Report Type:Expedited (15-DaCompany Report #GBS010408663 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Withdrawal Foreign Zyprexa PS Eli Lilly And Co Hospitalization - Syndrome Health Initial or Prolonged Alcoholism Professional Cardio-Respiratory Arrest Company Convulsion Representative Coronary Artery Other Atherosclerosis Overdose Date:04/30/01ISR Number: 3714308-6Report Type:Expedited (15-DaCompany Report #EWC010426465 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Disorder Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Lysanxia (Prazepam) C Professional Company Representative Other Date:04/30/01ISR Number: 3714312-8Report Type:Expedited (15-DaCompany Report #DE_010405568 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY Initial or Prolonged Overdose Health Tavor (Lorazepam) C Professional Paracetamol C Other 24-Jun-2005 12:19 PM Page: 1385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/01ISR Number: 3714437-7Report Type:Expedited (15-DaCompany Report #US_010463931 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Foreign Zyprexa PS Eli Lilly And Co 20 MG/1DAY Deficit/Hyperactivity Literature Disorder Health Delusion Professional Insomnia Mental Disorder Date:05/01/01ISR Number: 3714528-0Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Zyprexa (5mg) PS ORAL 10MG Q45 PO Hyperglycaemia Lithium C Ketoacidosis Date:05/01/01ISR Number: 3715178-2Report Type:Expedited (15-DaCompany Report #EMADSS2001002636 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged Hyponatraemia Health DAILY, ORAL Muscle Contractions Professional Depakine (Valproate Involuntary Sodium) SS ORAL 200 MG, 2 IN 1 DAILY, ORAL Deprax (Trazodone Hydrochloride) SS ORAL 100 MG, 2 IN 1, ORAL Distraneurine (Clomethiazole Edisilate) SS ORAL 192 MG, 2 IN 1, ORAL Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, ORAL Date:05/02/01ISR Number: 3715853-XReport Type:Expedited (15-DaCompany Report #2001SE03367 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Required Oedema Peripheral Health PO Intervention to Paraesthesia Professional Zyprexa SS ORAL 10 MG DAILY Prevent Permanent Vomiting Other PO Impairment/Damage Date:05/03/01ISR Number: 3717418-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100522 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Literature Neurontin PS Parke Davis Health Pharmaceuticals Ltd 900 MG Professional (DAILY) Risperidone (Risperidone) SS 6 MG (DAILY) Olanzapine 24-Jun-2005 12:19 PM Page: 1386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS 7.5 MG (DAILY) Fluvoxamine (Fluvoxamine) SS 300 MG (DAILY) Oxazepam (Oxazepam) SS 25 MG (DAILY) Date:05/07/01ISR Number: 3717686-7Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Olanzapine 10mg PS 10 MG QD Date:05/08/01ISR Number: 3718941-7Report Type:Direct Company Report # Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine (Zyprexa) PS 10 MG QHS Initial or Prolonged Polydipsia Required Polyuria Intervention to Prevent Permanent Impairment/Damage Date:05/08/01ISR Number: 3719123-5Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anticholinergic Syndrome Zyprexa PS ORAL 10MG Q 45 PO Diabetic Ketoacidosis Elavil C Dry Mouth Thorazine C Vision Blurred Prozac C Clonidone C Trazadone C Albuterol C Date:05/08/01ISR Number: 3719126-0Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Zyprexa 10mg PS ORAL 10MG 2 QHS PO Hyperglycaemia Lithium C Date:05/08/01ISR Number: 3719330-1Report Type:Expedited (15-DaCompany Report #GBS010408597 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Leukopenia Health Carbamazepine C Physical Assault Professional Clomipramine C Other Benztropine C Modecate (Fluphenazine Decanoate) C Thioridazine C 24-Jun-2005 12:19 PM Page: 1387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/01ISR Number: 3719335-0Report Type:Expedited (15-DaCompany Report #EWC010125207 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertrophy Foreign Zyprexa PS Eli Lilly And Co 7.5 MG DAY Initial or Prolonged Hypothalamo-Pituitary Health Disorders Professional Other Date:05/08/01ISR Number: 3719336-2Report Type:Expedited (15-DaCompany Report #EWC010225759 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa PS Eli Lilly And Co 28 DSG Hospitalization - Haemodialysis Health FORM/DAY Initial or Prolonged Intentional Misuse Professional Teralithe (Lithium Polyneuropathy Other Carbonate) C Pyrexia Tercian Renal Impairment (Cyamemazine) C Respiratory Distress Rhabdomyolysis Sepsis Shock Suicide Attempt Date:05/08/01ISR Number: 3719702-5Report Type:Expedited (15-DaCompany Report #EWC010426634 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphocyte Count Abnormal Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Neutropenia Health Thioridazine Professional Hydrochloride C Other Temazepam C Date:05/08/01ISR Number: 3719703-7Report Type:Expedited (15-DaCompany Report #GBS010408664 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Citalopram C Professional Thyroxine C Other Date:05/08/01ISR Number: 3719704-9Report Type:Expedited (15-DaCompany Report #GBS010408689 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neonatal Aspiration Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Health Citalopram C Professional Other 24-Jun-2005 12:19 PM Page: 1388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/01ISR Number: 3719705-0Report Type:Expedited (15-DaCompany Report #GBS010408651 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Foreign Zyprexa PS Eli Lilly And Co 30 MG DAY Initial or Prolonged Nephritis Interstitial Health Valproate Sodium C Renal Failure Acute Professional Trazodone C White Blood Cell Count Other Prednisolone C Increased Date:05/08/01ISR Number: 3719706-2Report Type:Expedited (15-DaCompany Report #GBS010408696 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Foreign Zyprexa PS Eli Lilly And Co Health Professional Company Representative Other Date:05/08/01ISR Number: 3720324-0Report Type:Expedited (15-DaCompany Report #US_010464503 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS Eli Lilly And Co 10 MG/DAY Urinary Tract Infection Professional Wellbutrin White Blood Cell Count Company (Amfebutamone Decreased Representative Hydrochloride) C Trazodone C Date:05/08/01ISR Number: 3720327-6Report Type:Expedited (15-DaCompany Report #US_010464683 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Zyprexa PS Eli Lilly And Co 20 MG/DAY 14 MON Decreased Professional Tegretol Company (Carbamazepine) C Representative Neurontin (Gabapentin) C Thorazine (Chlorpromazine Hydrochloride) C Klonopin (Clonazepam) C Date:05/08/01ISR Number: 3720329-XReport Type:Expedited (15-DaCompany Report #US_010464161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laryngeal Oedema Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Respiratory Distress Professional Company Representative 24-Jun-2005 12:19 PM Page: 1389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/01ISR Number: 3720497-XReport Type:Expedited (15-DaCompany Report #EWC010426569 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Life-Threatening Syndrome Health Moditen Hospitalization - Psychotic Disorder Professional (Fluphenazine Initial or Prolonged Company Enantate) C Representative Aspirine Other (Acetylsalicylic Acid) C Lithium C Depakine (Valproate Sodium) C Haloperidol C Date:05/08/01ISR Number: 3720498-1Report Type:Expedited (15-DaCompany Report #EWC010426581 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa PS Eli Lilly And Co 15 MG/ 1DAY 20 DAY Initial or Prolonged Neuroleptic Malignant Health Lithium Carbonate C Syndrome Professional Haloperidol C Polydipsia Company Renal Failure Acute Representative Other Date:05/08/01ISR Number: 3720502-0Report Type:Expedited (15-DaCompany Report #GBS010408669 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa PS Eli Lilly And Co 5 MG/ 1 DAY Condition Aggravated Literature Disorientation Health Extrapyramidal Disorder Professional Hallucination, Visual Other Persecutory Delusion Date:05/08/01ISR Number: 3720639-6Report Type:Expedited (15-DaCompany Report #US_010463418 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Increased Professional Blood Triglycerides Company Increased Representative Haematuria Hepatic Steatosis Mental Disorder Prostatitis Sedation Urinary Incontinence Weight Increased 24-Jun-2005 12:19 PM Page: 1390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/01ISR Number: 3720640-2Report Type:Expedited (15-DaCompany Report #US_010463327 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Concussion Health Zyprexa PS Eli Lilly And Co 20 MG/I AT Initial or Prolonged Pneumonia Professional BEDTIME 4 YR Other Post-Traumatic Amnestic Paxil (Paroxetine Disorder Hydrochloride) C Sinus Tachycardia Ambien (Zolpidem Vocal Cord Paralysis Tartrate) C Depakote (Valproate Semisodium) C Depakene (Valproate Sodium) C Norvasc (Amlodipine Besilate) C Hydrochlorothiazide/ Triamterene C Prevacid (Lansoprazole) C Date:05/08/01ISR Number: 3720641-4Report Type:Expedited (15-DaCompany Report #US_010260674 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Professional Prozac (Fluoxetine Company Hydrochloride) SS 10 MG/2 DAY Representative Date:05/09/01ISR Number: 3720456-7Report Type:Expedited (15-DaCompany Report #US_010259189 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa PS Eli Lilly And Co 7.5 MG / DAY Prolonged Professional Accupril (Quinapril Hydrochloride) C Trazodone C Sorbitol C Vitamin D C Zoloft (Sertraline Hydrochloride) C Miacalcin (Caltinonin, Salmon) C Nitro-Dur (Glyceryl Trinitrate) C Plavix (Clopidogrel Sulfate) C Marinol (Dronabinol) C Date:05/09/01ISR Number: 3721165-0Report Type:Expedited (15-DaCompany Report #10824720 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Encephalopathy Desyrel PS Apothecon Inc Div Hospitalization - Hyponatraemia Bristol Myers Squibb ORAL 100 Initial or Prolonged Muscle Contractions MILLIGRAM, Involuntary ORAL Depakine (Valproate 24-Jun-2005 12:19 PM Page: 1391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) SS ORAL 200 MILLIGRAM, ORAL Risperdal (Risperidone) SS 1 MILLIGRAM, ORAL Distraneurine (Chlormethiazole) SS ORAL 192 MILLIGRAM, ORAL Zyprexa (Olanzapine) SS ORAL 100 MILLIGRAM, ORAL Date:05/09/01ISR Number: 3723084-2Report Type:Periodic Company Report #US_000847672 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Halitosis Consumer Humatrope PS Eli Lilly And Co 1.4 MG/OTHER 2 WK Medication Error Zyprexa (Olanzapine) SS 5 MG/ AT BEDTIME 6 WK Clonazepam C Elavil (Amitriptyline Hydrochloride) C Cellcept (Mycophenolate Mofetil) C Date:05/10/01ISR Number: 3720685-2Report Type:Direct Company Report # Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pruritus Zyprexa (20mg) PS 20MG QD 1 DAY Intervention to Urticaria Topamax (25mg) SS 25MG QD 1 DAY Prevent Permanent Impairment/Damage Date:05/11/01ISR Number: 3720860-7Report Type:Expedited (15-DaCompany Report #B0098251A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Becotide PS Glaxo Wellcome RESPIRATORY (INHALATION) Ventoline SS Glaxo Wellcome RESPIRATORY (INHALATION) 100MCG Unknown Olanzapine SS ORAL Date:05/14/01ISR Number: 3723800-XReport Type:Expedited (15-DaCompany Report #US_010464632 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co 10 MG/ 1 AT Initial or Prolonged Haematuria Professional BEDTIME Renal Failure 24-Jun-2005 12:19 PM Page: 1392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/01ISR Number: 3723801-1Report Type:Expedited (15-DaCompany Report #US_010565042 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Pr Health Zyprexa PS Eli Lilly And Co 10 MG/ 1 AT Shortened Professional BEDTIME 5 WK Loxitane (Loxapine Succinate) C Multivitamins C Date:05/14/01ISR Number: 3723848-5Report Type:Expedited (15-DaCompany Report #US_000846920 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS Lilly Research Initial or Prolonged Herpes Simplex Professional Laboratories Div Eli Prescribed Overdose Company Lilly And Co 35 MG/AT Schizoaffective Disorder Representative BEDTIME Prozac (Fluoxetine Hydrochloride) SS 10 MG/EVERY OTHER DAY Depakote (Valproate Semisodium) C Prenate Ultra C Tylenol (Paracetamol) C Flagyl (Metronidazole) C Lotrine C Trichloroacetic Acid C Keflex (Cefalexin Monohydrate) C Lortab C Date:05/14/01ISR Number: 3723870-9Report Type:Expedited (15-DaCompany Report #US_010360827 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Zyprexa PS Eli Lilly And Co 4 WK Initial or Prolonged Coma Dyskinesia Dysphagia Hypertension Loss Of Consciousness Medication Error Muscle Twitching Renal Failure Rhabdomyolysis Date:05/14/01ISR Number: 3723872-2Report Type:Expedited (15-DaCompany Report #US_010565030 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Metrorrhagia Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Professional Company Representative 24-Jun-2005 12:19 PM Page: 1393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/01ISR Number: 3723882-5Report Type:Expedited (15-DaCompany Report #GBS010408663 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 470 MG Hospitalization - Phosphokinase Increased Health Paroxetine C Initial or Prolonged Cardio-Respiratory Arrest Professional Convulsion Company Coronary Artery Disease Representative Overdose Other Date:05/14/01ISR Number: 3723902-8Report Type:Expedited (15-DaCompany Report #EWC000205600 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Electrocardiogram Health Serenase Abnormal Professional (Haloperidol) C Tachycardia Other Truxal Ventricular Hypertrophy (Chlorprothixene Hydrochloride) C Disipal (Orphenadrine Hydrochloride) C Rivatril (Clonazepam) C Date:05/14/01ISR Number: 3723904-1Report Type:Expedited (15-DaCompany Report #EWC000607064 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Disipal Professional (Orphenadrine Other Hydrochloride) C Truxal (Chlorprothixene Hydrochloride) C Serenase (Haloperidol) C Rivotril (Clonazepam) C Date:05/14/01ISR Number: 3723906-5Report Type:Expedited (15-DaCompany Report #DE_010405568 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY Initial or Prolonged Neutropenia Health Tavor (Lorazepam0 C Overdose Professional Paracetamol C Other Date:05/14/01ISR Number: 3723926-0Report Type:Expedited (15-DaCompany Report #EWC010125207 Age:19 YR Gender:Female I/FU:F Outcome PT Hospitalization - Hypertrophy Initial or Prolonged Hypothalamo-Pituitary 24-Jun-2005 12:19 PM Page: 1394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorders Pregnancy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 7.5 MG DAY Health Professional Other Date:05/14/01ISR Number: 3723965-XReport Type:Expedited (15-DaCompany Report #GBS010408712 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Other Pulmonary Embolism Health Lithium Carbonate C Professional Sinemet C Other Benzhexol C Date:05/14/01ISR Number: 3723967-3Report Type:Expedited (15-DaCompany Report #EWC010426253 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accommodation Disorder Foreign Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Ruptured Cerebral Consumer Aricept (Donepezil Aneurysm Other Hydrochloride) C Magnyl C Norvasc (Amlodipine Besilate) C Prednisolone C Spersadex Comp C Date:05/14/01ISR Number: 3723968-5Report Type:Expedited (15-DaCompany Report #GBS010408717 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Libido Decreased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Penile Size Reduced Health Anafranil Other Professional (Clomipramine Other Hydrochloride) C Lithium C Atenolol C Bendrofluazide C Date:05/14/01ISR Number: 3724023-0Report Type:Expedited (15-DaCompany Report #EWC010426616 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 1395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/01ISR Number: 3724024-2Report Type:Expedited (15-DaCompany Report #EWC010526758 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Increased Health Liver Disorder Professional Other Date:05/14/01ISR Number: 3724087-4Report Type:Expedited (15-DaCompany Report #10824720 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Encephalopathy Foreign Desyrel PS Apothecon Inc Div Hospitalization - Hyponatraemia Health Bristol Myers Squibb ORAL 200 Initial or Prolonged Muscle Contractions Professional MILLIGRAMS, 1 Involuntary Other DAY ORAL Depakine (Valproate Sodium) SS ORAL 200 MILLIGRAM, 2/1 DAY ORAL Risperdal (Risperidone) SS ORAL 2 MILLIGRAM, 1 DAY ORAL Distraneurine (Chlormethiazole) SS ORAL 194 MILLIGRAM, 2/1 DAY ORAL Zyprexa (Olanzapine) SS ORAL 10 MILLIGRAM, 1 DAY ORAL Date:05/14/01ISR Number: 3724088-6Report Type:Expedited (15-DaCompany Report #GBS010508739 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Zyprexa PS Eli Lilly And Co 50 MG/DAY Bundle Branch Block Left Health Dizziness Professional Overdose Other Date:05/14/01ISR Number: 3724089-8Report Type:Expedited (15-DaCompany Report #EWC010526654 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Health Nozinan Professional (Levomepromazine) C Other Date:05/14/01ISR Number: 3724216-2Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 24-Jun-2005 12:19 PM Page: 1396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Belligerence Zyprexa 15mgs Eli Hallucination, Visual Lilly PS Eli Lilly ORAL 22.5 MGS AT Headache NIGHT ORAL Insomnia Depakote C Intentional Self-Injury Tegretal C Nausea Trileptal C Obsessive-Compulsive Disorder Physical Assault Date:05/16/01ISR Number: 3724146-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Benzodiazepine Initial or Prolonged Confusional State (Unknown-Not Prev. Delirium At This Site) Drug Withdrawal Syndrome Olanzepine PS Dysarthria Olanzapine At This Feeling Jittery Site SS Date:05/16/01ISR Number: 3724196-XReport Type:Direct Company Report # Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Apnoea Zyprexa Zydis PS ORAL 10 MG PO HS Intervention to Blood Creatine Hadol C Prevent Permanent Phosphokinase Increased Verapamil C Impairment/Damage Coma Paxil C Confusional State Cardura C Convulsion Valproic Acid C Dyspnoea Metabolic Acidosis Muscle Rigidity Neuroleptic Malignant Syndrome Date:05/17/01ISR Number: 3724436-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Olanzapine PS ORAL 5GM PO X 1 Hospitalization - Consciousness Mirtazapine C Initial or Prolonged Dysarthria Bupropion C Required Hypoventilation Obcp C Intervention to Overdose Prevent Permanent Tachycardia Impairment/Damage Tachypnoea 24-Jun-2005 12:19 PM Page: 1397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/01ISR Number: 3725898-1Report Type:Expedited (15-DaCompany Report #HQ8980428MAR2001 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Study Ativan PS Wyeth Ayerst Initial or Prolonged Fall Laboratories ORAL 2.5 MG 1X PER Other Haemorrhage 1 DAY;ORAL 1 DAY Head Injury Clomipramine Orthostatic Hypotension (Clomipramine, ) SS ORAL SEE IMAGE 4 DAY Diazepam (Diazepam, ) SS ORAL SEE IMAGE 4 DAY Olanzapine (Olanzapine, ) SS ORAL SEE IMAGE 27 DAY Heparin C ... C ... C ORAL 20 MG 1X PER 1 DAY;ORAL 1 DAY ... C ORAL 15 MG 1X PER 1 DAY;ORAL 2 DAY ... C ORAL 10 MG 1X PER 1 DAY;ORAL 1 DAY ... C ORAL 5 MG 1X PER 1 DAY;ORAL 4 DAY .... C ORAL 15 MG 1X PER 1 DAY;ORAL 27 DAY ... C ORAL 20 MG 1X PER 1 DAY;ORAL ... C Date:05/21/01ISR Number: 3726423-1Report Type:Expedited (15-DaCompany Report #US_010565220 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 10 MG 1 IN Hospitalization - Dry Mouth Professional THE EVENING Initial or Prolonged Hypersensitivity Prozac (Fluoxetine Vision Blurred Hydrochloride) SS UNKNOWN Elavil (Amitriptyline Hydrochloride) C Thorazine (Chlorpromazine Hydrochloride) C Clonidine C Trazodone C Albuterol C Methadone C Date:05/21/01ISR Number: 3726456-5Report Type:Expedited (15-DaCompany Report #10832210 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Serzone PS Bristol Myers Squibb Initial or Prolonged Increased Professional Co Pharmaceutical Aspartate Research Institute ORAL ORAL Aminotransferase Zyprexa (Olanzapine) SS 10 MILLIGRAM, Increased 1 DAY Schizophrenia Prozac (Fluoxetine Hcl) SS 60 MILLIGRAM, 1 DAY 24-Jun-2005 12:19 PM Page: 1398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Buspar Tabs C Cogentin C Coenzyme C Date:05/21/01ISR Number: 3726475-9Report Type:Expedited (15-DaCompany Report #US_010565250 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Hyperglycaemia Professional Lithium C Date:05/21/01ISR Number: 3726484-XReport Type:Expedited (15-DaCompany Report #US_010565235 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Hyperglycaemia Professional Lithium C Muscle Twitching Date:05/21/01ISR Number: 3726490-5Report Type:Expedited (15-DaCompany Report #US_010565049 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metastasis Health Zyprexa PS Eli Lilly And Co Phaeochromocytoma Professional Date:05/21/01ISR Number: 3726492-9Report Type:Expedited (15-DaCompany Report #US_001052548 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Increased Professional Zantac (Ranitidine Blood Lactate Hydrochloride) C Dehydrogenase Increased Estrace (Estradiol) C Blood Thyroid Stimulating Synthroid Hormone Increased (Levothyroxine Blood Triglycerides Sodium) C Increased Depakote (Valproate Chest Pain Semisodium) C Condition Aggravated Lipitor Coronary Artery Disease (Atorvastatin) C Hyperglycaemia Iron Sulfate C Ketonuria Vitamin C C Low Density Lipoprotein Toprol Xl Increased (Metoprolol Neutrophil Count Succinate) C Increased Quetiapine C Weight Increased White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 1399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/01ISR Number: 3726496-6Report Type:Expedited (15-DaCompany Report #US_010565379 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Hallucination, Auditory Lithium C Mania Suicide Attempt Date:05/21/01ISR Number: 3726500-5Report Type:Expedited (15-DaCompany Report #US_010464682 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS Eli Lilly And Co 10 MG/AT Oligomenorrhoea Professional BEDTIME 16 DAY Date:05/21/01ISR Number: 3726518-2Report Type:Expedited (15-DaCompany Report #US_010565479 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Health Zyprexa PS Eli Lilly And Co Haemorrhage Professional Aspirin C Company Representative Date:05/21/01ISR Number: 3726837-XReport Type:Expedited (15-DaCompany Report #GBS010508789 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperglycaemic Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Coma Health Sertraline C Professional Metformin C Other Date:05/21/01ISR Number: 3726838-1Report Type:Expedited (15-DaCompany Report #DE_010505685 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS Eli Lilly And Co 80 MG/DAY Initial or Prolonged Corneal Reflex Decreased Health Paroxetin Heart Rate Increased Professional (Paroxetine) C Muscle Spasms Other Overdose Pupillary Reflex Impaired Suicide Attempt Date:05/21/01ISR Number: 3726839-3Report Type:Expedited (15-DaCompany Report #EWC010526755 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Floxyfral Professional (Fluvoxamine Company Maleate) C Representative Pravasine Other (Pravastatin Sodium) C Dakar (Lansoprazole) C 24-Jun-2005 12:19 PM Page: 1400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/01ISR Number: 3726944-1Report Type:Expedited (15-DaCompany Report #A110652 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperglycaemic Foreign Zoloft PS Pfizer Other Coma Health Pharmaceuticals Inc ORAL 50.00 MG Required Professional TOTAL:DAILY:O Intervention to Other RAL Prevent Permanent Olanzapine SS ORAL 10.00 MG Impairment/Damage TOTAL:DAILY:O RAL Metformin C Date:05/21/01ISR Number: 3727091-5Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Malignant Zyprexa 5mg Lilly PS Lilly ORAL 5 MG HS PO Initial or Prolonged Neuroleptic Malignant Required Syndrome Intervention to Prevent Permanent Impairment/Damage Date:05/22/01ISR Number: 3727520-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Zyprexa (10mg)(Lilly) PS Lilly ORAL 10MG PO QHS Diflucan C Claritin C Vioxx C Depakote C Methadone C Date:05/22/01ISR Number: 3727648-1Report Type:Expedited (15-DaCompany Report #HQ0746310MAY2001 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Optic Neuritis Health Effexor PS Wyeth Ayerst Initial or Prolonged Vision Blurred Professional Laboratories ORAL SEE IMAGE Other Antabus (Disulfiram, Tablet) SS Zyprexa (Olanzapine, ) SS ORAL 15 MG 1X PER 1 DAY 758 DAY Akineton (Biperiden Lactate) C Tetracycline (Tetracycline) C Apodorm (Nitrazepam) C Sobril (Oxazepam) C Citodon (Codeine Phosphate/Paracetamo l) C 24-Jun-2005 12:19 PM Page: 1401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/01ISR Number: 3727407-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa 10mg Eli Lilly Company PS Eli Lilly Company 1 TABLET DAILY Zyrtec SS Pfizer Pharm 1 TABLET DAILY Date:05/23/01ISR Number: 3728415-5Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Zyprexa 2.5mg/5mg Intervention to Tabs Lilly PS Lilly ORAL 7.5MG PM/TID Prevent Permanent ORAL Impairment/Damage Date:05/24/01ISR Number: 3729487-4Report Type:Periodic Company Report #S00-USA-02153-01 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Celexa PS Forest Laboratories Hirsutism Professional Inc ORAL 30 MG QD PO Celexa (Citalopram Hydrobromide) SS ORAL 20 MG QD PO Zyprexa (Olanzapine) SS Date:05/24/01ISR Number: 3730218-2Report Type:Periodic Company Report #S01-USA-00189-01 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Celexa PS Forest Laboratories Drug Ineffective Inc ORAL 30 MG QD PO Celexa (Citalopram) SS ORAL 20 MG QD PO Celexa (Citalopram) SS ORAL 25 MG QD PO Celexa (Citalopram) SS ORAL 20 MG QD PO Zyprexia (Olanzapine) SS ORAL 3.75 MG QD PO Luvox (Fluvoxamine Maleate) C Azmacort (Triamcinolone Acetonide) C Ventolin (Salbutamol) C Date:05/25/01ISR Number: 3728425-8Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 1402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aspiration Zyprexa 10mg PS ORAL 10 MG PO QD Coma Haldol 5 Mg/Ml Inj SS 2 MG IM Q 4 Metabolic Acidosis HOURS PRN Pyrexia Shock Date:05/25/01ISR Number: 3728867-0Report Type:Expedited (15-DaCompany Report #A111051 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Navane PS Roerig Div Pfizer Initial or Prolonged Drug Interaction Professional Inc ORAL 30.00 MG Hallucination, Auditory TOTAL; DAILY; Paranoia ORAL Sedation Ziprasidone SS ORAL 160.00 MG Sleep Walking TOTAL; BID; Snoring ORAL Vomiting Zyprexa SS Weight Increased Serzone SS ORAL 600.00 MG TOTAL; DAILY; ORAL Cogentin C Thyroxine C Neurontin C Risperidone C Alcohol C Date:05/28/01ISR Number: 3728939-0Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Zyprexa, 20 Mg PS ORAL 1, PER DAY, Fatigue ORAL Fluid Retention Detrol, 4mg SS ORAL 1, PER DAY, Oedema Peripheral ORAL Sluggishness Weight Increased Date:05/29/01ISR Number: 3729886-0Report Type:Expedited (15-DaCompany Report #US_001152797 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Study Zyprexa PS Eli Lilly And Co 20 MG DAY Hospitalization - Drug Ineffective Health Olanzapine SS 10 MG/DAY Initial or Prolonged Hepatic Neoplasm Professional Placebo SS 2 MG/DAY Malignant Psychotic Disorder Date:05/29/01ISR Number: 3730032-8Report Type:Expedited (15-DaCompany Report #US_010260735 Age:21 YR Gender:Male I/FU:F Outcome PT Death Arrhythmia Drug Interaction 24-Jun-2005 12:19 PM Page: 1403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Thirst Report Source Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5 MG/DAY Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Prosom (Estazolam) C Date:05/29/01ISR Number: 3730416-8Report Type:Expedited (15-DaCompany Report #EWC010426634 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Thioridazine Professional Hydrocdhloride C Other Temazepam C Date:05/29/01ISR Number: 3730417-XReport Type:Expedited (15-DaCompany Report #DE_001204153 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Compartment Syndrome Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Diplopia Health Stilnox (Zolpidem) C Initial or Prolonged Paraesthesia Professional Kliogest C Peripheral Coldness Other Pyrexia Renal Impairment Rhabdomyolysis Tachycardia Thrombosis Date:05/29/01ISR Number: 3730449-1Report Type:Expedited (15-DaCompany Report #GBS010408660 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Health Professional Other Date:05/29/01ISR Number: 3730452-1Report Type:Expedited (15-DaCompany Report #EWC010526873 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Hospitalization - Dizziness Health Nozinan Initial or Prolonged Drug Level Changed Professional (Levomepromazine) C Hyperglycaemia Other Entumin (Clotiapine) C Hypotension Tavor (Lorazepam) C Loss Of Consciousness 24-Jun-2005 12:19 PM Page: 1404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3730454-5Report Type:Expedited (15-DaCompany Report #EWC010526857 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Cardiac Disorder Health Furesis (Furosemide) C Professional Egazil Duretter Other (Hyoscyamine Sulfate) C Kardopal C Rivatril (Clonazepam) C Permax (Pergolide Mesilate) C Oxepam (Oxazepam) C Multitabs C Neurobion Forte C Kalisol (Potassium Chloride) C Date:05/29/01ISR Number: 3730455-7Report Type:Expedited (15-DaCompany Report #EWC010526821 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Hepatic Enzyme Increased Consumer Depamide Sudden Death Health (Valpromide) C Supraventricular Professional Extrasystoles Other Weight Decreased Date:05/29/01ISR Number: 3730460-0Report Type:Expedited (15-DaCompany Report #EWC010526798 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Efexor (Venlafaxine Professional Hydrochloride) C Other Antabus (Disulfiram) C Akineton (Biperiden Hydrochloride) C Tetracycline "Nm Pharma" (Tetracycline Hydrochloride) C Apodorm (Nitrazepam) C Sobril (Oxazepam) C Citodon C Date:05/29/01ISR Number: 3730461-2Report Type:Expedited (15-DaCompany Report #EWC010526684 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY 2 DAY Hospitalization - Confusional State Health Initial or Prolonged Professional Other 24-Jun-2005 12:19 PM Page: 1405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3730462-4Report Type:Expedited (15-DaCompany Report #EWC010225719 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Blood Urea Increased Health Imovane (Zopiclone) C Initial or Prolonged Cardio-Respiratory Arrest Professional Cerebral Atrophy Other Convulsion Depressed Level Of Consciousness Hallucination, Visual Oral Intake Reduced Skin Infection Skin Ulcer Tonic Convulsion Date:05/29/01ISR Number: 3730463-6Report Type:Expedited (15-DaCompany Report #DE_010505759 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Differential White Blood Health Cell Count Abnormal Professional Leukopenia Other Date:05/29/01ISR Number: 3730464-8Report Type:Expedited (15-DaCompany Report #EWC010526935 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coagulation Factor Vii Foreign Zyprexa PS Eli Lilly And Co Level Decreased Health Coagulation Factor X Professional Level Decreased Company Liver Function Test Representative Abnormal Other Prothrombin Level Decreased Date:05/29/01ISR Number: 3730467-3Report Type:Expedited (15-DaCompany Report #AU_010503554 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Foreign Zyprexa PS Eli Lilly And Co Difficulty In Walking Consumer Dyspnoea Other Eating Disorder Epistaxis Mastication Disorder Vision Blurred Weight Increased Date:05/29/01ISR Number: 3730496-XReport Type:Expedited (15-DaCompany Report #US_010565970 Age:21 YR Gender:Male I/FU:I Outcome PT Other Aggression Belligerence 24-Jun-2005 12:19 PM Page: 1406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delusion Hallucination Obsessive-Compulsive Report Source Product Role Manufacturer Route Dose Duration Disorder Consumer Zyprexa PS Eli Lilly And Co 22.5 MG/DAY Tachycardia Depakote (Valproate Semisodium) C Tegretol (Carbamazepine) C Trileptal (Oxcarbazepine) C Date:05/29/01ISR Number: 3730497-1Report Type:Expedited (15-DaCompany Report #US_010565737 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Health Zyprexa PS Eli Lilly And Co Muscle Disorder Professional Depakote (Valproate Company Semisodium) C Representative Date:05/29/01ISR Number: 3730498-3Report Type:Expedited (15-DaCompany Report #US_010565439 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alveolitis Allergic Health Zyprexa PS Eli Lilly And Co 1 YR Interstitial Lung Disease Professional Lithium C Wellbutrin (Amfebutamone Hydrochloride) C Date:05/29/01ISR Number: 3730499-5Report Type:Expedited (15-DaCompany Report #US_010565605 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Irregular Health Zyprexa PS Eli Lilly And Co Professional Date:05/29/01ISR Number: 3730501-0Report Type:Expedited (15-DaCompany Report #US_010565562 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Health Zyprexa PS Eli Lilly And Co 10 MG/DAY 1 YR Initial or Prolonged Thrombocytopenic Purpura Professional Metoprolol C Zocor (Simvastatin C Clonidine C Synthroid (Levothyroxine Sodium) C Date:05/29/01ISR Number: 3730553-8Report Type:Expedited (15-DaCompany Report #US_010565402 Age:69 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Hyporeflexia Hypotension 24-Jun-2005 12:19 PM Page: 1407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Nervous System Disorder Overdose Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Wellbutrin (Amfebutamone Hydrochloride0 C Antihypertensive C Ect C Date:05/29/01ISR Number: 3730681-7Report Type:Expedited (15-DaCompany Report #EWC980400442 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Deficit/Hyperactivity Literature Haldol (Haloperidol) C Disorder Health Delusion Professional Dissociative Disorder Company Drug Withdrawal Syndrome Representative Hostility Other Insomnia Mania Medication Error Psychotic Disorder Date:05/29/01ISR Number: 3730686-6Report Type:Expedited (15-DaCompany Report #EWC010426616 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Professional Company Representative Other Date:05/29/01ISR Number: 3730688-XReport Type:Expedited (15-DaCompany Report #DE_010505685 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS Eli Lilly And Co 80 MG/DAY Initial or Prolonged Convulsion Health Paroxetin C Corneal Reflex Decreased Professional Heart Rate Increased Other Intentional Misuse Muscle Spasms Pupillary Reflex Impaired Suicide Attempt Date:05/29/01ISR Number: 3730835-XReport Type:Expedited (15-DaCompany Report #GBS010408689 Age:2 DY Gender:Female I/FU:F Outcome PT Hospitalization - Complications Of Maternal Initial or Prolonged Exposure To Therapeutic Other Drugs 24-Jun-2005 12:19 PM Page: 1408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congenital Pneumonia Forceps Delivery Prolonged Pregnancy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co Health Citalopram C Professional Other Date:05/29/01ISR Number: 3730838-5Report Type:Expedited (15-DaCompany Report #GBS010408663 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Withdrawal Foreign Zyprexa PS Eli Lilly And Co 470 MG Hospitalization - Syndrome Health Paroxetine C Initial or Prolonged Blood Creatinine Professional Increased Company Blood Glucose Increased Representative Cardio-Respiratory Arrest Other Convulsion Coronary Artery Atherosclerosis Coronary Artery Disease Drug Level Above Therapeutic Ecchymosis Hepatic Steatosis Overdose Pulmonary Congestion Date:05/29/01ISR Number: 3730840-3Report Type:Expedited (15-DaCompany Report #GBS000706281 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Foreign Zyprexa PS Eli Lilly And Co Completed Suicide Consumer Fluoxetine Drug Level Above Health (Fluoxetine Therapeutic Professional Hydrochloride) SS Ecchymosis Other Carbamazepine C Intentional Misuse Pulmonary Congestion Date:05/29/01ISR Number: 3730843-9Report Type:Expedited (15-DaCompany Report #EWC010526758 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 5 MG / 1 DAY Increased Health Aspartate Professional Aminotransferase Other Increased Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Increased Liver Disorder 24-Jun-2005 12:19 PM Page: 1409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/01ISR Number: 3731168-8Report Type:Expedited (15-DaCompany Report #US0112700 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Adderall 10 PS Shire Laboratories Professional Inc Company Zyprexa SS Representative Zyprexa (Olanzapine) C Date:05/31/01ISR Number: 3731230-XReport Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS Initial or Prolonged Quetiapine Fumarate C Required Bupropion Intervention to (Wellbutrin Sr) C Prevent Permanent Hydroxyzine C Impairment/Damage Dancate C Ibuprofen C Ketoconazol C Psyllion C Pyridoxine Hcl C Verapamil Hcl C Acetaminophen C Fluticasone Prop C Insulin Reg Human C Hydroxyzine C Date:06/04/01ISR Number: 3732905-9Report Type:Expedited (15-DaCompany Report #US_000439094 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Study Zyprexa PS Eli Lilly And Co 12 MG Uterine Haemorrhage Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG Ativan (Lorazepam) C Lo/Ovral C Multivitamin C Calcium C Tylenol (Paracetamol) C Ferrous Sulfate C Nasonex (Mometasone Furoate) C Date:06/04/01ISR Number: 3732909-6Report Type:Expedited (15-DaCompany Report #US_010464632 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Confusional State Professional BEDTIME Diabetes Mellitus Nausea Pyrexia Renal Failure Vomiting 24-Jun-2005 12:19 PM Page: 1410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3732919-9Report Type:Expedited (15-DaCompany Report #US_010463931 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Literature Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Deficit/Hyperactivity Health Disorder Professional Delusional Disorder, Persecutory Type Delusional Perception Drug Withdrawal Syndrome Insomnia Date:06/04/01ISR Number: 3733164-3Report Type:Expedited (15-DaCompany Report #EWC010426265 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa PS Eli Lilly And Co 35 MG Sedation Health Professional Other Date:06/04/01ISR Number: 3733510-0Report Type:Periodic Company Report #A108714 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon PS Pfizer Central Anorexia Research ORAL 40.00 MG Apathy TOTAL; BID; Dyskinesia ORAL Euphoric Mood Zyprexa SS ORAL ORAL Insomnia Tegretol C Nervousness Vitamin E C Psychotic Disorder Triphasal C Schizophreniform Disorder Inderal C Multi-Vitamin C Date:06/04/01ISR Number: 3733539-2Report Type:Periodic Company Report #A107311 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Geodon PS Pfizer Central Dizziness Research ORAL 20.00 MG Increased Appetite TOTAL:DAILY:O RAL Olanzapine SS Haloperidol C Vitamin C C Unspecified Pain Reliever C Date:06/04/01ISR Number: 3733896-7Report Type:Expedited (15-DaCompany Report #US_010463418 Age:23 YR Gender:Male I/FU:F Outcome PT Blood Cholesterol Increased Delusion 24-Jun-2005 12:19 PM Page: 1411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Haematuria Hepatic Steatosis Report Source Product Role Manufacturer Route Dose Duration Prostatitis Health Zyprexa (Olanzapine) PS Eli Lilly And Co 15 MG/DAY Sedation Professional Stress Company Urinary Incontinence Representative Weight Increased Date:06/05/01ISR Number: 3734126-2Report Type:Expedited (15-DaCompany Report #EWC010526961 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Haematemesis Health Professional Other Date:06/05/01ISR Number: 3734147-XReport Type:Expedited (15-DaCompany Report #CA_010503671 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Aminotransferase Health Increased Professional Blood Alkaline Company Phosphatase Increased Representative Diabetic Ketoacidosis Other Gamma-Glutamyltransferase Increased Malaise Medication Error Date:06/05/01ISR Number: 3734149-3Report Type:Expedited (15-DaCompany Report #EWC010526983 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Drug Interaction Health Deroxat (Paroxetine Professional Hydrochloride) C Other Date:06/05/01ISR Number: 3734606-XReport Type:Expedited (15-DaCompany Report #US_010566281 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Health Prozac (Fluoxetine Initial or Prolonged Professional Hydrochloride) SS 40 MG/DAY Other 24-Jun-2005 12:19 PM Page: 1412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734607-1Report Type:Expedited (15-DaCompany Report #US_010566275 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Arrest Foreign Zyprexa PS Eli Lilly And Co Health Professional Company Representative Other Date:06/05/01ISR Number: 3734850-1Report Type:Expedited (15-DaCompany Report #US_010566161 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 18 MON Professional Serzone (Nefazodone Hydrochloride) C Date:06/05/01ISR Number: 3735253-6Report Type:Expedited (15-DaCompany Report #US_010566366 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Health Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Increased Professional Depakote (Valproate Semisodium) C Adderall C Date:06/05/01ISR Number: 3735256-1Report Type:Expedited (15-DaCompany Report #US_010566117 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Health Zyprexa PS Eli Lilly And Co 150 MG/DAY Overdose Professional Date:06/05/01ISR Number: 3735318-9Report Type:Expedited (15-DaCompany Report #US_010566126 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Depakote (Valproate Confusional State Semisodium) C Delirium Metoprolol C Feeling Jittery Hyperhidrosis Neuroleptic Malignant Syndrome Tachycardia White Blood Cell Count Increased Date:06/05/01ISR Number: 3735319-0Report Type:Expedited (15-DaCompany Report #US_010566399 Age:29 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 1413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Literature Zyprexa PS Eli Lilly And Co 10 MG/DAY Disorientation Health Neuroleptic Malignant Professional Syndrome Pneumonia Aspiration Schizophrenia Sepsis Date:06/07/01ISR Number: 3735000-8Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Zyprexa 10 Mg Lilly PS Lilly ORAL 10 MG HS ORAL Multivitamins With Minerals C Date:06/08/01ISR Number: 3736390-2Report Type:Expedited (15-DaCompany Report #EWC010426569 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Life-Threatening Syndrome Health Moditen For Hospitalization - Professional Injection Initial or Prolonged Company (Fluphenazine Representative Enantate) C Other Aspirine (Acetylsalicylic Acid) C Lithium C Depakine (Valproate Sodium) C Haloperidol C Date:06/08/01ISR Number: 3736391-4Report Type:Expedited (15-DaCompany Report #EWC010526873 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Hospitalization - Drug Level Above Health Nozinan Initial or Prolonged Therapeutic Professional (Levomepromazine) C Hyperglycaemia Other Entumin (Clotiapine) C Hypotension Tavor (Lorazepam) C Loss Of Consciousness Date:06/08/01ISR Number: 3736392-6Report Type:Expedited (15-DaCompany Report #EWC010426581 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa PS Eli Lilly And Co 15 MG/1 DAY 20 DAY Initial or Prolonged Neuroleptic Malignant Health Lithium Carbonate C Syndrome Professional Haloperidol C Polydipsia Company Renal Failure Acute Representative Other 24-Jun-2005 12:19 PM Page: 1414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/01ISR Number: 3736423-3Report Type:Expedited (15-DaCompany Report #US_010565049 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Zyprexa PS Eli Lilly And Co Professional Date:06/08/01ISR Number: 3736435-XReport Type:Expedited (15-DaCompany Report #GBS010508903 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Deficit/Hyperactivity Health Thyroxine C Disorder Professional Hallucination, Auditory Other Speech Disorder Date:06/08/01ISR Number: 3736436-1Report Type:Expedited (15-DaCompany Report #GBS010508905 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 50 MG/DAY Initial or Prolonged First Degree Health Haloperidol C Dizziness Professional Procyclidine C Rectal Haemorrhage Other Zimovane (Zopiclone) C Lorazepam C Date:06/08/01ISR Number: 3736437-3Report Type:Expedited (15-DaCompany Report #CA_010603786 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration International Normalised Foreign Zyprexa PS Eli Lilly And Co 5 MG Ratio Increased Health Warfarin C Professional Other Date:06/08/01ISR Number: 3736438-5Report Type:Expedited (15-DaCompany Report #US_010666926 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Blood Creatinine Health Midazolam C Increased Professional Blood Urea Increased Other Electrolyte Imbalance Haematuria Ketonuria Neuroleptic Malignant Syndrome Polyuria Proteinuria Tremor 24-Jun-2005 12:19 PM Page: 1415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/01ISR Number: 3736440-3Report Type:Expedited (15-DaCompany Report #GBS010608933 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa PS Eli Lilly And Co Hospitalization - Hepatorenal Failure Health Initial or Prolonged Loss Of Consciousness Professional Overdose Other Pulmonary Oedema Date:06/08/01ISR Number: 3736445-2Report Type:Expedited (15-DaCompany Report #GBS010508739 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Zyprexa PS Eli Lilly And Co 50 MG/DAY Initial or Prolonged Atrioventricular Block Health Other First Degree Professional Syncope Other Date:06/08/01ISR Number: 3736446-4Report Type:Expedited (15-DaCompany Report #EWC010426240 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa PS Eli Lilly And Co 10 MG DAY Initial or Prolonged Gamma-Glutamyltransferase Health Eltroxin Increased Professional (Levothyroxine Hepatic Function Abnormal Other Sodium) C Pyrexia Litarex (Lithium Citrate) C Optimol (Timolol Maleate) C Remeron (Mirtazapine) C Date:06/08/01ISR Number: 3736470-1Report Type:Expedited (15-DaCompany Report #US_010464646 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Oedema Health Zyprexa (Olanzapine) PS Eli Lilly And Co 5 MG/DAY Other Professional Imuran C ORAL 100 MG/DAY PO Cyclosporine C ORAL 125 MG/2 DAY PO Prednisone C ORAL 10 MG/1 EVERY OTHER DAY PO Cardizem Cd C ORAL 180 MG/DAY PO Date:06/08/01ISR Number: 3736472-5Report Type:Expedited (15-DaCompany Report #US_010566723 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Study Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Haemorrhage Health Aspirin C ORAL 81 MG/DAY PO International Normalised Professional Axid C ORAL 300 MG/DAY PO Ratio Increased Betapace C ORAL 40 MG/DAY PO Prothrombin Time Depakote C ORAL 1500 MG/DAY Prolonged PO Effexor C ORAL 225 MG/DAY PO Enulose C 15 DSG 24-Jun-2005 12:19 PM Page: 1416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report FORM/DAY Warfarin C ORAL 5 MG/DAY PO Lorazepam C ORAL 1 MG/AS NEEDED PO Multivitamin C ORAL 1 DSG FORM/DAY PO Date:06/08/01ISR Number: 3736555-XReport Type:Expedited (15-DaCompany Report #US_010666906 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombotic Health Zyprexa PS Eli Lilly And Co Thrombocytopenic Purpura Professional Company Representative Date:06/08/01ISR Number: 3736798-5Report Type:Expedited (15-DaCompany Report #HQ1056018MAY2001 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Ativan PS Wyeth Ayerst Other Convulsion Health Laboratories ORAL 30 MG 1X PER Hyporeflexia Professional 1 DAY; ORAL Intentional Misuse Other Seroxat (Paroxetine Hydrochloride, ) SS ORAL 280 MG 1X PER 1 DAY; ORAL 1 DAY Zyprexia (Olanzapine, ) SS ORAL 80 MG 1X PER 1 DAY; ORAL 1 DAY Date:06/08/01ISR Number: 3737642-2Report Type:Expedited (15-DaCompany Report #US_010566687 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS Eli Lilly And Co 5 MG / 2 DAY; Initial or Prolonged Personality Disorder Professional A FEW MONTHS Psychotic Disorder Paxil (Paroxetine Hydrochloride) C Wellbutrin (Amfebutamone Hydrochloride) C Date:06/08/01ISR Number: 3737643-4Report Type:Expedited (15-DaCompany Report #US_010666811 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Zyprexa PS Eli Lilly And Co 5 MG/1 AT Depression BEDTIME 13 MON Granulomatous Liver Prozac (Fluoxetine Disease Hydrochloride) SS 40 MG/1 IN Haemosiderosis THE MORNING 14 MON Sedation Polyethylene Glycol C Suicidal Ideation Syncope 24-Jun-2005 12:19 PM Page: 1417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/01ISR Number: 3737645-8Report Type:Expedited (15-DaCompany Report #US_010666975 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Professional Company Representative Date:06/08/01ISR Number: 3737648-3Report Type:Expedited (15-DaCompany Report #US_010566375 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Weight Increased Seroquel C Lithium C Haldol Decanoate (Haloperidol Decanoate) C Date:06/08/01ISR Number: 3737651-3Report Type:Expedited (15-DaCompany Report #US_010566463 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa PS Eli Lilly And Co Initial or Prolonged Pancreatitis Acute Other Phlebothrombosis Renal Failure Acute Date:06/12/01ISR Number: 3740278-0Report Type:Periodic Company Report #US_010361193 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Axid PS Eli Lilly And Co 300 MG/2 DAY Initial or Prolonged Health Olanzapine SS 15 MG DAY Professional Ativan (Lorazepam) C Date:06/12/01ISR Number: 3740281-0Report Type:Periodic Company Report #US_010259070 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Study Axid PS Eli Lilly And Co 150 MG/2 DAY Health Olanzapine SS 10 MG AT Professional BEDTIME Lotrisone C Sominex C Date:06/12/01ISR Number: 3740285-8Report Type:Periodic Company Report #US_000745659 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Study Axid PS Eli Lilly And Co 150 MG 2/DAY Initial or Prolonged Myasthenic Syndrome Health Olanzapine SS 10 MG/AT Professional BEDTIME Montelukast C Nasacort (Triamcinolo9ne 24-Jun-2005 12:19 PM Page: 1418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetonide) C Benztropine C Date:06/12/01ISR Number: 3740288-3Report Type:Periodic Company Report #US_000643688 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Axid PS Eli Lilly And Co 150 MG/2 DAY Initial or Prolonged Health Olanzapine SS 10 MG Professional Date:06/12/01ISR Number: 3740290-1Report Type:Periodic Company Report #US_000134711 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Study Axid PS Eli Lilly And Co Initial or Prolonged Health Olanzapine SS 10 MG Professional Date:06/13/01ISR Number: 3738162-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Zyprexa 7.5mg Hs PS ORAL 7.5MG PO HS Initial or Prolonged Congenital Anomaly THROUGH OUT Disability Crying PREGNANCY Congenital Anomaly Neonatal Disorder Zoloft 50mg Hs SS 50MG HS Neonatal Respiratory THROUGHOUT Failure PREGNNACY Obstructive Airways Disorder Posturing Respiratory Disorder Neonatal Swelling Umbilical Cord Abnormality Date:06/13/01ISR Number: 3738863-5Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Olanzapine 10mg PS ORAL 10 MG PO Q HS Other Bradykinesia Apap C Required Catatonia Amiodarone C Intervention to Confusional State Asa Ec C Prevent Permanent Decreased Activity Benztropine C Impairment/Damage Drooling Combivent Ihl C Lethargy K-Dur C Muscle Rigidity Lactulose C Sedation Olanzapine C Trazodone C Valproate Sodium C 24-Jun-2005 12:19 PM Page: 1419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3740685-6Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS Initial or Prolonged Quetiapine Fumarate C Required Bupropion Intervention to (Wellbutrin Sr) C Prevent Permanent Hydroxyzine C Impairment/Damage Pancote C Ibuprofen C Ketoconazole 2% Shampoo C Psyllium C Pyridoxine Hcl C Verapamil Hcl C Acetaminophen C Fluticasone C Insulin Reg C Hydroxyzine C Pyridoxine C Date:06/19/01ISR Number: 3742074-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Olanzapine PS Initial or Prolonged Neuroleptic Malignant Depakote C Required Syndrome Intervention to Prevent Permanent Impairment/Damage Date:06/19/01ISR Number: 3742393-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Prolixin Decanoate PS INTRAMUSCULAR 37.5MG IM Hospitalization - Rhabdomyolysis Q2WEEKS Initial or Prolonged Olanzapine SS ORAL 10MG PO QHS Required Amantadine C Intervention to Adalat Cc C Prevent Permanent Fluoxetine C Impairment/Damage Docusate C Date:06/19/01ISR Number: 3742511-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100747 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angiopathy Literature Neurontin PS Pfizer Inc 900 MG Initial or Prolonged Intentional Misuse Health Olanzapine Priapism Professional (Olanzapine) SS 5 MG (NIGHT), Suicide Attempt Paroxetine (Paroxetine) SS 20 MG (NIGHT), 24-Jun-2005 12:19 PM Page: 1420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3742609-4Report Type:Expedited (15-DaCompany Report #GBS010508905 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 50 MG/DAY Initial or Prolonged First Degree Health Haloperidol C Dizziness Professional Procyclidine C Electrocardiogram Other Schizophrenia C Abnormal Rectal Haemorrhage Date:06/19/01ISR Number: 3742611-2Report Type:Expedited (15-DaCompany Report #GBS010508739 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS Eli Lilly And Co 50 MG/DAY Initial or Prolonged First Degree Health Haloperidol C Other Bundle Branch Block Left Professional Procyclidine C Conduction Disorder Other Zimovane C Dizziness Lorazepam C Date:06/19/01ISR Number: 3742618-5Report Type:Expedited (15-DaCompany Report #GBS010408696 Age:65 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Foreign Zyprexa PS Eli Lilly And Co Health Professional Company Representative Other Date:06/19/01ISR Number: 3742621-5Report Type:Expedited (15-DaCompany Report #GBS010408651 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Zyprexa PS Eli Lilly And Co 30 MG DAY Initial or Prolonged Renal Failure Acute Health Valproate Sodium C Professional Trazodone C Company Prednisolone C Representative Other Date:06/19/01ISR Number: 3742653-7Report Type:Expedited (15-DaCompany Report #GBS010608933 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa PS Eli Lilly And Co 1.4 Hospitalization - Hepatorenal Failure Health MILLIGRAM/LIT Initial or Prolonged Loss Of Consciousness Professional ER Pulmonary Oedema Other Colchicine C 24-Jun-2005 12:19 PM Page: 1421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3742656-2Report Type:Expedited (15-DaCompany Report #GBS001006751 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Overdose Health Sudden Death Professional Company Representative Date:06/19/01ISR Number: 3742787-7Report Type:Expedited (15-DaCompany Report #2001SE04434 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Health PO Prevent Permanent Professional Zyprexa SS 20 MG DAILY Impairment/Damage Other Depakine C Dormicum "Roche" C Akineton C Date:06/19/01ISR Number: 3742921-9Report Type:Expedited (15-DaCompany Report #EWC010526873 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Hospitalization - Drug Level Above Health Nozinan Initial or Prolonged Therapeutic Professional (Levomepromazine) C Hyperglycaemia Other Entumin (Clotiapine) C Hypotension Tavor (Lorazepam) C Loss Of Consciousness Renal Failure Date:06/19/01ISR Number: 3742924-4Report Type:Expedited (15-DaCompany Report #DE_010505685 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa PS Eli Lilly And Co 80 MG/DAY Initial or Prolonged Corneal Reflex Decreased Health Paroxetin Heart Rate Increased Professional (Paroxetin) C Muscle Spasms Other Tavor (Lorazepam) C Overdose Suicide Attempt Date:06/19/01ISR Number: 3742926-8Report Type:Expedited (15-DaCompany Report #CA_001202411 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cleft Palate Foreign Zyprexa PS Eli Lilly And Co Congenital Anomaly Complications Of Maternal Health Other Exposure To Therapeutic Professional Drugs Company Heart Rate Decreased Representative Kidney Malformation Other Polydactyly Trisomy 18 24-Jun-2005 12:19 PM Page: 1422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3743228-6Report Type:Expedited (15-DaCompany Report #A113027 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperphagia Health Zoloft PS Pfizer Intervention to Impaired Gastric Emptying Professional Pharmaceuticals Inc Prevent Permanent Vomiting Ziprasidone SS Impairment/Damage Weight Decreased Zyprexa SS Weight Increased Date:06/19/01ISR Number: 3743240-7Report Type:Expedited (15-DaCompany Report #US_010667011 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Humulin-Human Movement Disorder Insulin (Rdna) Unknown Formulation (Hu PS Prozac (Fluoxetine Hydrochloride) SS Zyprexa (Olanzapine) SS 15 MG/1 DAY Dilantin (Phenytoin Sodium) C Date:06/19/01ISR Number: 3743268-7Report Type:Expedited (15-DaCompany Report #US_010667057 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Permax PS Eli Lilly And Co 0.25 MG/2 DAY Pericardial Effusion Professional Zyprexa SS Other Mysoline (Primidone) C Propranolol C Lasix (Furosemide) C K-Dur (Potassium Chloride) C Date:06/19/01ISR Number: 3743409-1Report Type:Expedited (15-DaCompany Report #US_010566723 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Study Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Dehydration Health Aspirin C Gastrointestinal Professional Axid (Nizatidine) C Haemorrhage Betapace (Sotalol Prothrombin Time Hydrochloride) C Prolonged Depakote (Valproate Renal Failure Acute Semisodium) C Effexor (Venlafaxine Hydrochloride) C Enulose (Lactulose) C Warfarin C Lorazepam C Multivitamin C 24-Jun-2005 12:19 PM Page: 1423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/01ISR Number: 3743563-1Report Type:Expedited (15-DaCompany Report #10832210 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Serzone PS Bristol Myers Squibb Initial or Prolonged Increased Other Co Pharmaceutical Aspartate Research Institute ORAL 200MG, ORAL Aminotransferase Zyprexa (Olanzapine) SS ORAL 10 MG, 1 DAY, Increased ORAL Schizophrenia Ambien C Buspar Tabs C Coenzyme C Cogentin C Prilosec C Inderal C Date:06/20/01ISR Number: 3743565-5Report Type:Expedited (15-DaCompany Report #US_010667166 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:06/20/01ISR Number: 3743566-7Report Type:Expedited (15-DaCompany Report #US_010667371 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Faecaloma Professional Other Company Representative Date:06/20/01ISR Number: 3743567-9Report Type:Expedited (15-DaCompany Report #US_010667368 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Zyprexa PS Eli Lilly And Co Initial or Prolonged Faecaloma Professional Other Company Representative Date:06/20/01ISR Number: 3743587-4Report Type:Expedited (15-DaCompany Report #US_010667275 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS Eli Lilly And Co Professional Zestril (Lisinopril) C Company Cardizem (Diltiazem Representative Hydrochloride0 C Norvasc (Amlodipine Besilate) C 24-Jun-2005 12:19 PM Page: 1424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/01ISR Number: 3743596-5Report Type:Expedited (15-DaCompany Report #NSADSS2001017040 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Literature Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Initial or Prolonged Potentiation Health ORAL Priapism Professional Fluvoxamine (Fluvoxamine) SS ORAL 300 MG, DAILY, ORAL Olanzapine (Olanzapine) SS ORAL 7.5 MG, DAILY, ORAL Gabapentin (Gabapentin) C Oxazepam (Oxazepam) C Date:06/20/01ISR Number: 3743606-5Report Type:Expedited (15-DaCompany Report #US_010260706 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Dysphagia Professional Paxil (Paroxetine Other Dysphasia Hydrochloride) C Electrolyte Imbalance Extrapyramidal Disorder Gait Disturbance Hypokalaemia Neuroleptic Malignant Syndrome Oedema Peripheral Pyoderma Urinary Tract Infection Date:06/20/01ISR Number: 3743693-4Report Type:Expedited (15-DaCompany Report #EWC010627204 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Grand Mal Convulsion Health Amantan C Weight Increased Professional Date:06/20/01ISR Number: 3743694-6Report Type:Expedited (15-DaCompany Report #CA_010603802 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Foreign Zyprexa PS Eli Lilly And Co 15 MG/1 DAY 3 MON Health Professional Date:06/20/01ISR Number: 3743766-6Report Type:Expedited (15-DaCompany Report #DE_010606023 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Aponal C ORAL PO 8 WK Professional Isoptin Retard C ORAL PO Other Zoloft C ORAL PO 24-Jun-2005 12:19 PM Page: 1425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/01ISR Number: 3743800-3Report Type:Expedited (15-DaCompany Report #CA_010403514 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Foreign Zyprexa PS Eli Lilly And Co 7.5 MG AT Initial or Prolonged Polydipsia Health BEDTIME Disability Polyneuropathy Professional Lithium C Other Polyuria Other Epival (Valproate Semisodium) C Anti-Inflammatory C Allopurinol C Date:06/20/01ISR Number: 3743803-9Report Type:Expedited (15-DaCompany Report #EWC010627131 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Leukopenia Health Thrombocytopenia Professional Other Date:06/20/01ISR Number: 3743805-2Report Type:Expedited (15-DaCompany Report #EWC010527062 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Foreign Zyprexa PS Eli Lilly And Co 5 MG/AT Initial or Prolonged Oedema Peripheral Health BEDTIME Professional Other Date:06/20/01ISR Number: 3743823-4Report Type:Expedited (15-DaCompany Report #DE_010605969 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY White Blood Cell Count Health Edronax (Olanzapine) C 15 MG/DAY Decreased Professional Tavor (Lorazepam) C Other Date:06/20/01ISR Number: 3743825-8Report Type:Expedited (15-DaCompany Report #GBS010608940 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa PS Eli Lilly And Co 25 MG/DAY Corrected Interval Health Lithium C Prolonged Professional Losec (Omeprazole) C Overdose Other Melleril (Thioridazine Hydrochloride) C Date:06/20/01ISR Number: 3743827-1Report Type:Expedited (15-DaCompany Report #EWC010627170 Age:70 YR Gender:Female I/FU:I Outcome PT Other Ecchymosis Haematoma Oedema 24-Jun-2005 12:19 PM Page: 1426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain In Extremity Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co Health Thyrax Professional (Levothyroxine) C Lorazepam C Priadel (Lithium Carbonate) C Nortilen (Nortriptyline Hydrochloride) C Losec (Omeprazole) C Adalat (Nifedipine) C Date:06/20/01ISR Number: 3743828-3Report Type:Expedited (15-DaCompany Report #US_010667036 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hallucination Health Mental Disorder Professional Other Date:06/20/01ISR Number: 3743829-5Report Type:Expedited (15-DaCompany Report #EWC000406490 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eclampsia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Pregnancy Health Professional Other Date:06/20/01ISR Number: 3743882-9Report Type:Expedited (15-DaCompany Report #US_010667031 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Condition Aggravated Professional Depakote (Valproate Headache Company Semisodium) C Vision Blurred Representative Date:06/22/01ISR Number: 3745003-5Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradyphrenia Zyprexa 5 Mg PS ORAL 5MG HS PO Intervention to Drug Withdrawal Syndrome Seroquel SS ORAL 50MG BID PO Prevent Permanent Fatigue Wellbutrin C Impairment/Damage Malaise Serzone C Vertigo Lamictal C Neurontin C 24-Jun-2005 12:19 PM Page: 1427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/01ISR Number: 3746664-7Report Type:Expedited (15-DaCompany Report #2001SE04424 Age:72 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Other Seroquel PS Astrazeneca Lp ORAL 25 MG BID PO Zyprexa SS 5 MG DAILY Remeron C Stilnox C Hygroton C Tenormin C Date:06/25/01ISR Number: 3747254-2Report Type:Expedited (15-DaCompany Report #PHEH2001US04201 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Health Clozaril PS Novartis Chills Professional Pharmaceuticals Corp ORAL 650 MG, ORAL Drug Interaction Zyprexa (Olanzapine) SS SEE IMAGE 2907 DAY Leukopenia Seroquel Neutropenia (Quetiapine) C Pharyngolaryngeal Pain Synthroid C Pneumonia Inderal C Buspar (Buspirone Hydrochloride) C Efexor Er (Venlafaxine Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Ddavp (Desmopressin) C Date:06/26/01ISR Number: 3747192-5Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa (Olanzapine) Hospitalization - Polydipsia Lilly PS Lilly ORAL 2.5 PO Q AM Initial or Prolonged Polyuria 12.5 PO Q PM Other Required Intervention to Prevent Permanent Impairment/Damage Date:06/26/01ISR Number: 3747252-9Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Olanzapine 25 Mg PS ORAL 25 MG PO QHS Hospitalization - Increased Zoloft C Initial or Prolonged Diabetic Ketoacidosis Dilantin C White Blood Cell Count Haldol C Increased Cogentin C Inderal C 24-Jun-2005 12:19 PM Page: 1428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3747807-1Report Type:Expedited (15-DaCompany Report #US_010260691 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Study Zyprexa PS Eli Lilly And Co Initial or Prolonged Dyspnoea Health Fluoxetine Heart Rate Increased Professional (Fluoxetine Hydrochloride) SS Mircette C Multivitamin C Prempro C Asa (Acetylsalicylic Acid) C Zantac (Ranitidine Hydrochloride) C Date:06/26/01ISR Number: 3747893-9Report Type:Expedited (15-DaCompany Report #US_010566117 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Pr Health Zyprexa PS Eli Lilly And Co 150 MG/DAY Initial or Prolonged Shortened Professional Paxil (Paroxetine Other Intentional Misuse Hydrochloride) C Lethargy Sinus Tachycardia Suicide Attempt Tachycardia Date:06/26/01ISR Number: 3747894-0Report Type:Expedited (15-DaCompany Report #US_010464646 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Oedema Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Hospitalization - Pulmonary Oedema Professional Imuran Initial or Prolonged (Azathioprine) C Other Cyclosporine C Prednisone C Cardizem Cd (Diltiazem Hydrochloride) C Date:06/26/01ISR Number: 3747895-2Report Type:Expedited (15-DaCompany Report #US_010361657 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperosmolar Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Life-Threatening Coma Professional Hospitalization - Influenza Like Illness Initial or Prolonged Pneumonia Pulmonary Embolism Renal Failure Upper Gastrointestinal Haemorrhage Weight Increased 24-Jun-2005 12:19 PM Page: 1429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3747896-4Report Type:Expedited (15-DaCompany Report #US_000134310 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Embolism Health Lithium C Disability Gangrene Professional Antihypertensive C Other Hyperglycaemia Leg Amputation Neuroleptic Malignant Syndrome Pain In Extremity Poor Peripheral Circulation Renal Impairment Vomiting Weight Increased Date:06/26/01ISR Number: 3747897-6Report Type:Expedited (15-DaCompany Report #US_991232959 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aortic Thrombosis Consumer Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Hospitalization - Coagulopathy Health Lithium C Initial or Prolonged Dehydration Professional Valproic Acid C Disability Diabetic Hyperosmolar Vasotec (Enalapril Other Coma Maleate) C Drug Level Above Clonazepam C Therapeutic Niaspan (Nicotinic Foot Amputation Acid) C Gangrene Indocin Hyperglycaemia (Indometacin) C Leukocytosis Nephrogenic Diabetes Insipidus Neuroleptic Malignant Syndrome Pain In Extremity Peripheral Ischaemia Peripheral Vascular Disorder Pseudomonas Infection Pyrexia Renal Impairment Vomiting Weight Increased Date:06/26/01ISR Number: 3747898-8Report Type:Expedited (15-DaCompany Report #US_001153158 Age:78 YR Gender:Female I/FU:F Outcome PT Death Asthenia Atherosclerosis Bundle Branch Block Right Cardiac Disorder Cardiomegaly Chromaturia Compression Fracture Dysphagia Electrocardiogram Qt 24-Jun-2005 12:19 PM Page: 1430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Corrected Interval Prolonged Heart Rate Increased Ventricular Extrasystoles Report Source Product Role Manufacturer Route Dose Duration Study Zyprexa PS Eli Lilly And Co 2 DSG FORM/AT Health BEDTIME Professional Centrum Silver C Vitamin E C Detrol (Tolterodine L-Tartrate) C Date:06/26/01ISR Number: 3747931-3Report Type:Expedited (15-DaCompany Report #DE_010606023 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Decreased Health Aponal (Doxepin Influenza Like Illness Professional Hydrochloride C Leukocytosis Other Isoptin Retard Lymphopenia (Verapamil Neutrophilia Hydrochloride) C Zoloft (Sertraline Hydrochloride C Date:06/26/01ISR Number: 3747944-1Report Type:Expedited (15-DaCompany Report #EWC000406490 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eclampsia Foreign Zyprexa PS Eli Lilly And Co 10MG/DAY Initial or Prolonged Health Professional Other Date:06/26/01ISR Number: 3747946-5Report Type:Expedited (15-DaCompany Report #GBS010608940 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa PS Eli Lilly And Co 30 MG/DAY Corrected Interval Health Lithium C Prolonged Professional Melleril Electrocardiogram T Wave Company (Thioridazine Inversion Representative Hydrochloride) C Overdose Other Tegretol (Carbamazepine) C Dalmane (Flurazepam Hydrochloride) C Date:06/26/01ISR Number: 3747947-7Report Type:Expedited (15-DaCompany Report #GBS010508903 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Deficit/Hyperactivity Health Thyroxine C Disorder Professional Cerebral Atrophy Other Hallucination, Auditory Speech Disorder 24-Jun-2005 12:19 PM Page: 1431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3747948-9Report Type:Expedited (15-DaCompany Report #GBS001006751 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Sudden Death Health Professional Company Representative Other Date:06/26/01ISR Number: 3747959-3Report Type:Expedited (15-DaCompany Report #CA_001202411 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cleft Palate Foreign Zyprexa PS Eli Lilly And Co Congenital Anomaly Complications Of Maternal Health Other Exposure To Therapeutic Professional Drugs Company Death Neonatal Representative Heart Rate Decreased Other Kidney Malformation Polydactyly Trisomy 18 Date:06/26/01ISR Number: 3747961-1Report Type:Expedited (15-DaCompany Report #EWC010627131 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Leukopenia Health Thrombocytopenia Professional Other Date:06/26/01ISR Number: 3747962-3Report Type:Expedited (15-DaCompany Report #EWC010526654 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Health Nozinan Professional (Levomepromazine) C Other Benzodiazepine C Date:06/26/01ISR Number: 3748047-2Report Type:Expedited (15-DaCompany Report #EWC010627201 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Thrombocytopenia Health Depamide C Professional Other 24-Jun-2005 12:19 PM Page: 1432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3748048-4Report Type:Expedited (15-DaCompany Report #GBS010608959 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Chlorpromazine C Professional Lithium C Other Aspirin C Atenolol C Allopurinol C Date:06/26/01ISR Number: 3748050-2Report Type:Expedited (15-DaCompany Report #DE_010606027 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Lymphocyte Count Health Remergil Decreased Professional (Mirtazapine) C Other Atosil (Isopromethazine Hydrochloride) C Ximovan (Zopiclone) C Ass C Lopirin (Captopril) C Bronchoretard (Theophylline) C Magnesium Verla (Magnesium Hydrogen Aspartate) C Pulmicort (Budesonide) C Atrovent (Ipratropium Bromide) C Sortis (Atorvastatin Calcium) C Tavor (Lorazepam) C Edronax (Reboxetine) C Amoxihexal (Amoxicillin Trihydrate) C Zoloft (Sertraline Hyrocholoride) C Date:06/26/01ISR Number: 3748207-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Tegretol PS Decreased Zyprexa SS Date:06/26/01ISR Number: 3748223-9Report Type:Expedited (15-DaCompany Report #GBS010608984 Age: Gender:Male I/FU:I Outcome PT Report Source Death Diabetes Mellitus Foreign Non-Insulin-Dependent Health Lung Neoplasm Malignant Professional Malignant Melanoma Company 24-Jun-2005 12:19 PM Page: 1433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Date:06/26/01ISR Number: 3748471-8Report Type:Expedited (15-DaCompany Report #US_010667930 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa PS Eli Lilly And Co Date:06/26/01ISR Number: 3748525-6Report Type:Expedited (15-DaCompany Report #US_010667830 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 6 DAY Initial or Prolonged Corrected Interval Paxil (Paroxetine Prolonged Hydrochloride) C Memory Impairment Synthroid Palpitations (Levothyroxine Tachycardia Sodium) C Date:06/26/01ISR Number: 3748527-XReport Type:Expedited (15-DaCompany Report #US_010565372 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Zyprexa PS Eli Lilly And Co 30 MG/1 DAY Initial or Prolonged Increased Lithium C Aspartate Neurontin Aminotransferase (Gabapentin) C Increased Blood Cholesterol Increased Blood Triglycerides Increased Condition Aggravated Psychotic Disorder Weight Increased Date:06/26/01ISR Number: 3748528-1Report Type:Expedited (15-DaCompany Report #US_000439362 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bicarbonate Literature Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Decreased Health Effexor (Venlafaxine Other Blood Ph Decreased Professional Hydrochloride) C Depression Risperdal Diabetes Mellitus (Risperidone) C Non-Insulin-Dependent Imipramine C Diabetic Ketoacidosis Hallucination Hypokalaemia Pco2 Decreased Po2 Increased Renal Tubular Necrosis Weight Increased 24-Jun-2005 12:19 PM Page: 1434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/01ISR Number: 3748410-XReport Type:Direct Company Report # Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Zyprexa (Olanzapine) PS ORAL 10 MG HS P.O. Intervention to Lithium Carbonate C Prevent Permanent Augmentin C Impairment/Damage Aricept I Date:06/28/01ISR Number: 3748664-XReport Type:Expedited (15-DaCompany Report #262790 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Xenical PS Roche Initial or Prolonged Schizophrenia Professional Zyprexa I THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Teralithe I THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Date:06/28/01ISR Number: 3749204-1Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Olanzapine PS Vision Blurred Valproic Acid C Benztropine C Lithium C Pseudoephedrine C Date:06/29/01ISR Number: 3750293-9Report Type:Expedited (15-DaCompany Report #17812-136 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Consumer Lithium Carbonate PS Roxane Laboratories Initial or Prolonged Imprisonment Inc ORAL 600 Road Traffic Accident MG,BID,ORAL 10 YR Zyprexa(Olanzapine)T ablet, 10mg Eli Lilly SS Eli Lilly ORAL 10MG,QHS,ORAL Trazadone C Ativan (Lorazepam) C Inderal (Propranolol) C Date:07/02/01ISR Number: 3750733-5Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Zyprexa PS ORAL 15MG AT HS PO Intervention to Seroquel SS ORAL 300 MG AT HS Prevent Permanent PO Impairment/Damage 24-Jun-2005 12:19 PM Page: 1435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751052-3Report Type:Expedited (15-DaCompany Report #US_010666926 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Blood Creatinine Health Midazolam C Increased Professional Blood Urea Increased Other Electrolyte Imbalance Haematuria Ketonuria Neuroleptic Malignant Syndrome Polyuria Proteinuria Date:07/02/01ISR Number: 3751054-7Report Type:Expedited (15-DaCompany Report #262790 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Xenical PS Hlr Technology ORAL ORAL Initial or Prolonged Drug Interaction Health Zyprexa (Olanzapine) SS ORAL ORAL Medication Error Professional Teralithe (Lithium Persecutory Delusion Carbonate) SS ORAL ORAL Schizophrenia Date:07/02/01ISR Number: 3751310-2Report Type:Expedited (15-DaCompany Report #002-0945-M0100045 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Neurontin PS Pfizer Inc ORAL PER ORAL Health Zyprexia Professional (Olanzapine) SS Hydromorphone SS Date:07/02/01ISR Number: 3751365-5Report Type:Expedited (15-DaCompany Report #US_010668227 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Zyprexa PS Eli Lilly And Co Loss Of Consciousness Lithium C Sedation Vomiting Weight Decreased Date:07/02/01ISR Number: 3751368-0Report Type:Expedited (15-DaCompany Report #US_010668246 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY Burning Sensation Dyazide C Oedema Peripheral Micronase Pain In Extremity (Glibenclamide) C Tenormin (Atenolol) C Premarin (Estrogens Conjugated) C Zestril (Lisinopril) C Ditropan 24-Jun-2005 12:19 PM Page: 1436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Oxybutynin) C Allegra (Fexofenadine Hydrochloride) C Axid (Nizatidine) C Valium (Diazepam) C Ambien (Zolpidem Tartrate) C Date:07/02/01ISR Number: 3751371-0Report Type:Expedited (15-DaCompany Report #US_010668176 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Consumer Zyprexa PS Eli Lilly And Co 7.5 MG/1 DAY 4 YR Date:07/02/01ISR Number: 3751374-6Report Type:Expedited (15-DaCompany Report #US_010668038 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthritis Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY Diarrhoea Depakene (Valproate Dizziness Sodium) C Sedation Neurontin Vomiting (Gabapentin) C Weight Increased Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Nasonex (Mometasone Furoate) C Claritin (Loratadine) C Benadryl (Diphenhydramine Hydrochloride) C Date:07/02/01ISR Number: 3751378-3Report Type:Expedited (15-DaCompany Report #US_010566723 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Study Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Gastrointestinal Health Aspirin C Haemorrhage Professional Axid (Nizatidine) C Haematuria Betapace (Sotalol International Normalised Hydrochloride) C Ratio Increased Depakote (Valproate Prothrombin Time Semisodium) C Prolonged Effexor (Venlafaxine Rectal Haemorrhage Hydrochloride) C Renal Failure Acute Enulose (Lactulose) C Warfarin C Lorazepam C Multivitamin C Desoximetasone C Nizoral Shampoo (Ketoconazole) C 24-Jun-2005 12:19 PM Page: 1437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751862-2Report Type:Expedited (15-DaCompany Report #GBS010608960 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Increased Health Aspartate Professional Aminotransferase Other Increased Blood Creatine Phosphokinase Increased Date:07/02/01ISR Number: 3751872-5Report Type:Expedited (15-DaCompany Report #EWC010627370 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Increased Health Aspartate Professional Aminotransferase Other Increased Date:07/02/01ISR Number: 3751873-7Report Type:Expedited (15-DaCompany Report #EWC010627330 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Increased Health Akineton (Bipriden Aspartate Professional Hydrochloride) C Aminotransferase Other Clopixol Increased (Zuclopentrhixol Blood Lactate Decanoate) C Dehydrogenase Increased Condition Aggravated Convulsion Gamma-Glutamyltransferase Increased Infection Macroglossia Neutrophil Count Increased Psychotic Disorder White Blood Cell Count Increased Date:07/02/01ISR Number: 3751874-9Report Type:Expedited (15-DaCompany Report #EWC010627325 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Thrombocytopenia Health Loxapac (Loxapine Professional Succinate) C Other 24-Jun-2005 12:19 PM Page: 1438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751875-0Report Type:Expedited (15-DaCompany Report #EWC010526935 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coagulation Factor Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Decreased Health Zoloft (Sertraline Coagulation Factor Vii Professional Hydrochloride) C Level Decreased Company Risperdal Representative (Risperidone) C Other Date:07/02/01ISR Number: 3751876-2Report Type:Expedited (15-DaCompany Report #EWC010526843 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG/2 DAY Initial or Prolonged Increased Health Enapren (Enalapril Aspartate Professional Maleate) C Aminotransferase Other Tiklid (Ticlopidine Increased Hydrochloride) C Asthenia Zantac (Rantidine Blood Pressure Decreased Hydrochloride) C Dyspnoea En (Delorazepam) C Dyspnoea Exertional Diuretic C Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Hypertensive Heart Disease Psychotic Disorder Date:07/03/01ISR Number: 3752168-8Report Type:Expedited (15-DaCompany Report #EWC010627329 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Hospitalization - Ventricular Fibrillation Health Xanax (Alprazolam) C Initial or Prolonged Professional Betaloc Zok Company (Metoprolol Representative Tartrate) C Other Date:07/03/01ISR Number: 3752245-1Report Type:Expedited (15-DaCompany Report #EWC010326171 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Asthenia Health Imovane (Zopiclone) C Hepatitis Professional Forlax (Macrogol) C Hypothermia Other Hept-A-Myl Lung Disorder (Heptaminol Lymphopenia Hydrochloride) C Neutropenia Pneumonia Thrombocytopenia 24-Jun-2005 12:19 PM Page: 1439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/01ISR Number: 3752246-3Report Type:Expedited (15-DaCompany Report #EWC010526755 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hepatic Steatosis Health Floxyfral Hepatitis Professional (Fluvoxamine Company Maleate) C Representative Pravasine Other (Pravastatin Sodium) C Dakar (Lansoprazole) C Date:07/03/01ISR Number: 3752258-XReport Type:Expedited (15-DaCompany Report #EWC010627344 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Zyprexa PS Eli Lilly And Co 5 MG/1 DAY Initial or Prolonged Oedema Health Cipramil (Citalopram Weight Increased Professional Hydrobromide) C Company Representative Other Date:07/03/01ISR Number: 3752265-7Report Type:Expedited (15-DaCompany Report #EWC01025336 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Leukopenia Consumer Depamide C Pyrexia Other Gardenal C Urbanyl C Date:07/03/01ISR Number: 3752266-9Report Type:Expedited (15-DaCompany Report #EWC010225759 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa PS Eli Lilly And Co 280 MG/DAY Hospitalization - Drug Level Above Health Teralithe (Lithium Initial or Prolonged Therapeutic Professional Carbonate) C Haemodialysis Other Tercian Immobile (Cyamemazine) C Pain In Extremity Zoloft (Sertraline Paraesthesia Hydrochloride) C Polyneuropathy Pyrexia Renal Impairment Respiratory Distress Rhabdomyolysis Sepsis Shock Suicide Attempt Date:07/03/01ISR Number: 3752267-0Report Type:Expedited (15-DaCompany Report #GBS010609026 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Death Intentional Misuse Foreign Health 24-Jun-2005 12:19 PM Page: 1440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 720 MG/DAY Prozac (Fluoxetine Hydrochloride) C Date:07/03/01ISR Number: 3752268-2Report Type:Expedited (15-DaCompany Report #GBS010609021 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Overdose Consumer Orphenadrine C Health Professional Company Representative Other Date:07/03/01ISR Number: 3752680-1Report Type:Expedited (15-DaCompany Report #GBS010608933 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Zyprexa PS Eli Lilly And Co Hospitalization - Cardiac Arrest Health Colchicine C Initial or Prolonged Hepatic Steatosis Professional Diazepam C Hepatitis Company Prozac (Fluoxetine Hepatomegaly Representative Hydrochloride) C Hepatorenal Failure Other Loss Of Consciousness Overdose Pulmonary Oedema Renal Tubular Necrosis Suicidal Ideation Date:07/03/01ISR Number: 3752682-5Report Type:Expedited (15-DaCompany Report #AU_010603721 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Decreased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Bradycardia Health Coversyl Initial or Prolonged Condition Aggravated Professional (Perindopril) C Convulsion Other Drug Toxicity Hypertension Polydipsia Date:07/03/01ISR Number: 3752683-7Report Type:Expedited (15-DaCompany Report #EWC010627158 Age:46 YR Gender:Male I/FU:I Outcome PT Hospitalization - Arthralgia Initial or Prolonged Blood Alkaline Phosphatase Increased Blood Creatine Phosphokinase Mb Increased 24-Jun-2005 12:19 PM Page: 1441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscular Weakness Myalgia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 20 MG 16 MON Health Tegretol Professional (Carbamazepine) C Other Kemadrin (Procyclidine Hydrochloride) C Chlorpromazine C Date:07/03/01ISR Number: 3752686-2Report Type:Expedited (15-DaCompany Report #CA_010603921 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa PS Eli Lilly And Co Health Celexa (Citalopram Professional Hydrobromide) C Company Valproate Semisodium C Representative Other Date:07/03/01ISR Number: 3752688-6Report Type:Expedited (15-DaCompany Report #EWC010225685 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Prostatic Foreign Zyprexa PS Eli Lilly And Co 5 MG DAY Initial or Prolonged Hyperplasia Health Neoplasm Malignant Professional Company Representative Other Date:07/04/01ISR Number: 3752297-9Report Type:Expedited (15-DaCompany Report #US_010464116 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY Hypersensitivity Health Levothyroxine C Obstructive Airways Professional Antibiotic C Disorder Aspirin C Date:07/04/01ISR Number: 3752298-0Report Type:Expedited (15-DaCompany Report #US_010464161 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastric Cancer Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY 3 DAY Hospitalization - Oropharyngeal Swelling Professional Lithium C Initial or Prolonged Respiratory Distress Company Depakote C Other Stridor Representative Paxil C Prilosec C 24-Jun-2005 12:19 PM Page: 1442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/04/01ISR Number: 3752299-2Report Type:Expedited (15-DaCompany Report #US_010566687 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS Eli Lilly And Co 5 MG/ 2 DAY Initial or Prolonged Professional A FEW MONTHS Paxil C Wellbutrin C Date:07/04/01ISR Number: 3752300-6Report Type:Expedited (15-DaCompany Report #US_010668104 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Health Professional Date:07/05/01ISR Number: 3752553-4Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Klonopin 2mg Tid PS Initial or Prolonged Luvox SS 100MG Q1 Risperdal SS 4MG HS Zyprexia SS 20MG HS Date:07/05/01ISR Number: 3752634-5Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Haloperidol Conc. PS 10MG BID Initial or Prolonged Decanoate SS 250MG Q3W IM Olanzapine SS ORAL 10MG DAILY PO Lithium Citrate C Sertraline C Docusate Sodium C Lactulose C Date:07/05/01ISR Number: 3753407-XReport Type:Periodic Company Report #250180 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Clonopin PS Hoffmann La Roche Dry Mouth Inc ORAL 0.5 MG 1 PER Muscle Disorder DAY ORAL Neck Pain Zyprexa (Olanzapine) SS 20 MG DAILY Pain In Extremity Sedation Date:07/05/01ISR Number: 3753619-5Report Type:Expedited (15-DaCompany Report #2001SE04434 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Health PO Prevent Permanent Professional Zyprexa SS 20 MG DAILY Impairment/Damage Other Depakine C 24-Jun-2005 12:19 PM Page: 1443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dormicin "Roche" C Akineton C Date:07/05/01ISR Number: 3753621-3Report Type:Expedited (15-DaCompany Report #2001SE04424 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG BID PO Intervention to Health Zyprexa SS 5 MG DAILY Prevent Permanent Professional Remeron C Impairment/Damage Other Stilnox C Hygroton C Tenormin C Date:07/05/01ISR Number: 3753634-1Report Type:Expedited (15-DaCompany Report #A114881 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombocytopenia Foreign Zoloft PS Pfizer Health Pharmaceuticals Inc ORAL DAILY:ORAL Professional Olanzapine SS ORAL ORAL Company Representative Date:07/06/01ISR Number: 3752994-5Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Olanzepine PS ORAL 10MG QD ORAL Hospitalization - Hyperphagia Maxzide C Initial or Prolonged Citalopram C Date:07/06/01ISR Number: 3753892-3Report Type:Expedited (15-DaCompany Report #US0115800 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Steatosis Health Adderall 10 PS Shire Pharmaceutical Sudden Death Professional Development Inc 20 MG BID 2 YR Company Zyprexa SS 5 MG QD 2 YR Representative Zyprexa C Date:07/09/01ISR Number: 3753828-5Report Type:Expedited (15-DaCompany Report #A0149276A Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Health Lamictal PS Glaxo Wellcome ORAL 50MG Twice Initial or Prolonged Bradykinesia Professional per day Other Dermatitis Olanzapine SS ORAL 10MG At night 186 DAY Rash Erythematous Synthroid C Glaxo Wellcome ORAL 100MG Per day Skin Discolouration 24-Jun-2005 12:19 PM Page: 1444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/01ISR Number: 3754907-9Report Type:Expedited (15-DaCompany Report #US_010668237 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Tremor Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Professional Depakote (Valproate Semisodium) C Date:07/09/01ISR Number: 3754908-0Report Type:Expedited (15-DaCompany Report #US_010668264 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Consumer Zyprexa PS Eli Lilly And Co 10 MG/AT Imprisonment Other BEDTIME Road Traffic Accident Haldol (Haloperidol) C Ativan (Lorazepam) C Trazodone C Inderal (Propranolol Hydrochloride) C Lithium C Date:07/09/01ISR Number: 3754909-2Report Type:Expedited (15-DaCompany Report #US_010668286 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Therapeutic Agent Zyprexa PS Eli Lilly And Co Toxicity Hydrocodone W/Acetaminophen C Date:07/09/01ISR Number: 3755324-8Report Type:Expedited (15-DaCompany Report #JACGBR2000000511 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Droleptan(Unspecifie Initial or Prolonged Depressed Level Of Health d) (Droperidol) PS INTRAMUSCULAR IM Consciousness Professional Zyprexa (Olanzapine) SS 10 MG, 2 IN 1 Drug Interaction DAY(S) Drug Level Above Fluoxetine Therapeutic Hydrochloride SS ORAL ORAL Mefenamic Acid C Lorazepam C Date:07/09/01ISR Number: 3755507-7Report Type:Expedited (15-DaCompany Report #EWC010325817 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Fungal Skin Infection Health Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 1445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/01ISR Number: 3755508-9Report Type:Expedited (15-DaCompany Report #DE_010606176 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co Health Professional Other Date:07/09/01ISR Number: 3755509-0Report Type:Expedited (15-DaCompany Report #DE_010606185 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Health Amitriptyline C Professional Date:07/09/01ISR Number: 3755510-7Report Type:Expedited (15-DaCompany Report #EWC010426242 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Initial or Prolonged Mydriasis Health Depamide Pyrexia Professional (Valpromide) C Other Sulfarlem (Anethole Trithione) C Date:07/09/01ISR Number: 3755511-9Report Type:Expedited (15-DaCompany Report #US_010667802 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Foreign Zyprexa PS Eli Lilly And Co 10 MG/AT Deficit/Hyperactivity Health BEDTIME Disorder Professional Linton (Haloperidol) C Convulsion Company Orap (Pimozide) C Fall Representative Amlodin (Amlodipine Inappropriate Affect Other Besilate) C Insomnia Rohypnol Soliloquy (Flunitrazepam) C Tasmolin (Biperiden) C Hiberna (Promethazine Hydrochloride) C Date:07/09/01ISR Number: 3755512-0Report Type:Expedited (15-DaCompany Report #GBS010609044 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Citalopram C Professional Other 24-Jun-2005 12:19 PM Page: 1446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/01ISR Number: 3755515-6Report Type:Expedited (15-DaCompany Report #EWC010627170 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Foreign Zyprexa PS Eli Lilly And Co Ecchymosis Health Thyrax C Eosinophilia Professional Lorazepam C Extrapyramidal Disorder Other Priadel (Lithium Fall Carbonate) C Haematoma Nortrilen Leukocytosis (Nortriptyline Neutrophilia Hydrochloride) C Pain In Extremity Losec (Omeprazole) C Swelling Adalat (Nifedipine) C Thrombocythaemia Formoterol C Flixotide (Fluticasone Propionate) C Date:07/09/01ISR Number: 3755516-8Report Type:Expedited (15-DaCompany Report #GBS010609021 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Completed Suicide Consumer Orphenadrine C Drug Level Above Health Droperidol C Therapeutic Professional Procyclidine C Overdose Company Paroxetine C Toxicologic Test Abnormal Representative Other Date:07/09/01ISR Number: 3755542-9Report Type:Expedited (15-DaCompany Report #EWC010627420 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gestational Diabetes Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Pregnancy Health Effexor (Venlafaxine Weight Increased Professional Hydrochloride) C Other Trazolan (Trazodone Hydrochloride) C Iron C Sultrin C Promognor C Gynomyk (Butoconazole Nitrate) C Date:07/09/01ISR Number: 3755543-0Report Type:Expedited (15-DaCompany Report #EWC010627397 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co Hospitalization - Sepsis Health Remeron Initial or Prolonged White Blood Cell Count Professional (Mirtazapine) C Decreased Other Tazocin C Targocid (Teicoplanin) C Fungustatin (Fluconazole) C 24-Jun-2005 12:19 PM Page: 1447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sucralfate C Enoxaparin Sodium C Furosemide C Lorazepam C Salbutamol C Levophed (Norepinephrine Bitartrate) C Date:07/09/01ISR Number: 3755544-2Report Type:Expedited (15-DaCompany Report #EWC010627417 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bone Marrow Depression Foreign Zyprexa PS Eli Lilly And Co Other Haldol (Haloperidol) C Tercian (Cyamemazine) C Date:07/09/01ISR Number: 3755545-4Report Type:Expedited (15-DaCompany Report #GBS010608956 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Fluid Retention Health Warfarin C International Normalised Professional Venlafaxine C Ratio Increased Company Priadel (Lithium Representative Carbonate) C Other Omeprazole C Efamast (Evening Primrose Oil) C Date:07/09/01ISR Number: 3755546-6Report Type:Expedited (15-DaCompany Report #EWC010627438 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Foreign Zyprexa PS Eli Lilly And Co 15 MG DAY Initial or Prolonged Health Professional Other Date:07/09/01ISR Number: 3755548-XReport Type:Expedited (15-DaCompany Report #EWC010627460 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Femur Fracture Study Oxazepam C Disability Health Tramadol C Professional Ranitidine C Other Nitrazepam C Date:07/09/01ISR Number: 3755551-XReport Type:Expedited (15-DaCompany Report #EWC010627408 Age:24 YR Gender:Male I/FU:I Outcome PT Alanine Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 1448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Health Haloperidol C Professional Tavor (Lorazepam) C Other Akineton (Biperiden Hydrochloride) C Date:07/09/01ISR Number: 3755600-9Report Type:Expedited (15-DaCompany Report #DE_010606027 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Decreased Health Remergil Professional (Mirtazapine) C ORAL Other Atosil (Isopromethazine Hydrochloride) C Ximovan (Zopiclone0 C ORAL Ass C ORAL Lopirin (Captopril) C ORAL Bronchoretard (Theophylline) C ORAL Magnesium Verla (Magnesium Hydrogen Aspartate) C ORAL Pulmicort (Budesonide) C Atrovent (Ipratropium Bromide) C Tavor (Lorazepam) C Edronax (Reboxetine) C Amoxihexal (Amoxicillin Trihydrate) C Zoloft (Sertraline Hydrochloride) C Date:07/09/01ISR Number: 3755601-0Report Type:Expedited (15-DaCompany Report #EWC010225349 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dehydration Foreign Zyprexa PS Eli Lilly And Co 7.5 MG DAY Eosinophilia Health Tranxene Infection Professional (Clorazepate Neuroleptic Malignant Other Dipotassium) C Syndrome Tranxene C Date:07/09/01ISR Number: 3755602-2Report Type:Expedited (15-DaCompany Report #EWC010527062 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythromelalgia Foreign Zyprexa PS Eli Lilly And Co 5 MG/AT Initial or Prolonged Health BEDTIME Professional Pergolide C Other Madopar C 24-Jun-2005 12:19 PM Page: 1449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dulcolax (Bisacodyl) C Dormicum (Midazolam Maleate) C Lasix (Furosemide) C Date:07/09/01ISR Number: 3755603-4Report Type:Expedited (15-DaCompany Report #EWC010225759 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa PS Eli Lilly And Co 280 MG/DAY Hospitalization - Circulatory Collapse Health Teralithe (Lithium Initial or Prolonged Haemodialysis Professional Carbonate) C Intentional Misuse Other Tercian Pain In Extremity (Cyamemazine) C Polyneuropathy Zoloft (Sertraline Pyrexia Hydrochloride) C Renal Failure Acute Respiratory Distress Rhabdomyolysis Shock Suicide Attempt Date:07/09/01ISR Number: 3755604-6Report Type:Expedited (15-DaCompany Report #AU_010603721 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Decreased Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Bradycardia Health Coversyl Initial or Prolonged Convulsion Professional (Perindopril) C Drug Toxicity Other Hypertension Polydipsia Date:07/09/01ISR Number: 3756151-8Report Type:Expedited (15-DaCompany Report #US_010668372 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Overdose Professional Effexor (Venlafaxine Hydrochloride) C Lamictal (Lamotrigine) C Date:07/09/01ISR Number: 3756153-1Report Type:Expedited (15-DaCompany Report #US_010668480 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS Eli Lilly And Co 2.5 MG/DAY Skin Ulcer Professional Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/01ISR Number: 3756156-7Report Type:Expedited (15-DaCompany Report #US_010668373 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS Eli Lilly And Co 5 MG/IN THE Pain In Extremity MORNING 2 YR Paralysis Digoxin C Tremor Paxil (Paroxetine Hydrochloride) C Tamoxifen C Date:07/09/01ISR Number: 3756190-7Report Type:Expedited (15-DaCompany Report #EWC010627373 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 40 MG/DAY Overdose Health Professional Company Representative Other Date:07/10/01ISR Number: 3754889-XReport Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Olanzapine PS 5MG (?) @ 3 Initial or Prolonged Rhabdomyolysis WEEKS PTA 3 WK Zoloft C Valproic Acid C Date:07/10/01ISR Number: 3755941-5Report Type:Expedited (15-DaCompany Report #10894574 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Prolixin Decanoate PS Apothecon Inc Div Initial or Prolonged Delirium Health Bristol Myers Squibb ORAL 100 MG, Medication Error Professional 1/TOTAL ORAL Overdose Company Olanzapine SS ORAL 450 MG, 1/ Representative TOTAL ORAL Other Date:07/10/01ISR Number: 3756931-9Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Olanzapine PS ORAL 25 MG QD ORAL Initial or Prolonged Amprenavir 150 Mg SS ORAL 1200 MG BID Disability ORAL Indinavir C Efavirenz C Pravastatin C Sertraline C Fluconazole C Beclomethasone C Klonipin C 24-Jun-2005 12:19 PM Page: 1451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/01ISR Number: 3756953-8Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Olanzapine Abnormal (Zyprexa/Lilly) PS ORAL 15 MG PO QD Grand Mal Convulsion Lithium C Paroxetine C Fluphenazine C Amantadine C Date:07/11/01ISR Number: 3756997-6Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Zyprexa (10mg) PS ORAL 10MG QHS PO Initial or Prolonged Dyskinesia DOSE TITRATED Extrapyramidal Disorder UP 5-8-01 Movement Disorder Date:07/12/01ISR Number: 3757006-5Report Type:Expedited (15-DaCompany Report #A0149276A Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Health Lamictal PS Glaxo Wellcome Inc ORAL 50 MG (TWICE Initial or Prolonged Bradykinesia Professional PER DAY) ORAL Required Rash Erythematous Olanzapine Intervention to (Olanzapine) SS ORAL 10 MG (AT Prevent Permanent NIGHT) ORAL Impairment/Damage Thyroxine Sodium C Date:07/12/01ISR Number: 3757107-1Report Type:Direct Company Report # Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Zyprexa (5 Mg) PS 5MG 1T QID, I Circulatory Collapse DOSE Decreased Activity Sinemet (50/200) SS 50/200 1T BID Difficulty In Walking ROUTINELY Fatigue Aggrenox C Hypersomnia Megestrol C Thinking Abnormal Ranitidine C Estratrol C Celexa C Date:07/13/01ISR Number: 3758540-4Report Type:Expedited (15-DaCompany Report #FLUV00301003053 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Foreign Luvox PS Solvay Initial or Prolonged Mydriasis Literature Pharmaceuticals ORAL 150 MG DAILY Tremor Other PO Olanzapine (Olanzapine) SS SEE IMAGE 24-Jun-2005 12:19 PM Page: 1452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3759533-3Report Type:Expedited (15-DaCompany Report #EWC010627420 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gestational Diabetes Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Pregnancy Health Effexor (Venlafaxine Weight Increased Professional Hydrochloride) C Other Trazolan (Trazodone Hydrochloride) C Iron C Sultrin C Promognor C Gynomyk (Butoconazole Nitrate) C Date:07/16/01ISR Number: 3759551-5Report Type:Expedited (15-DaCompany Report #US_010768727 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Eli Lilly And Co 15 MG/DAY Professional Company Representative Date:07/16/01ISR Number: 3759552-7Report Type:Expedited (15-DaCompany Report #US_010768802 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa PS Eli Lilly And Co 20 MG/1 DAY Professional Lithium C Company Representative Date:07/16/01ISR Number: 3759554-0Report Type:Expedited (15-DaCompany Report #US_010768752 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Zyprexa PS Eli Lilly And Co 15 MG/1 DAY Initial or Prolonged Diabetes Mellitus Lipitor Hypertension (Atorvastatin) C Mental Disorder Loxitane (Loxapine Myocardial Infarction Succinate) C Neuroleptic Malignant Lithium C Syndrome Psychotic Disorder Pyrexia Renal Failure Suicide Attempt White Blood Cell Count Increased Date:07/16/01ISR Number: 3759569-2Report Type:Expedited (15-DaCompany Report #EWC001209440 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Hospitalization - Pulmonary Embolism Foreign Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 1453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5 MG/DAY Stilnox (Zolpidem) C Date:07/16/01ISR Number: 3759570-9Report Type:Expedited (15-DaCompany Report #EWC010627460 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Femur Fracture Study Oxazepam C Disability Osteoporosis Health Tramadol C Professional Ranitidine C Other Nitrazepam C Date:07/16/01ISR Number: 3759571-0Report Type:Expedited (15-DaCompany Report #GBS010609044 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Neutropenia Health Citalopram C White Blood Cell Count Professional Decreased Company Representative Other Date:07/16/01ISR Number: 3759572-2Report Type:Expedited (15-DaCompany Report #EWC010426569 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 DAY Life-Threatening Syndrome Health Moditen For Hospitalization - Professional Injection Initial or Prolonged Company (Fluphenazine Representative Enantate) C Other Aspirine (Acetylsalicylic Acid) C Lithium C Depakine (Valproate Sodium) C Haloperidol C Date:07/16/01ISR Number: 3759574-6Report Type:Expedited (15-DaCompany Report #EWC010526821 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Hepatic Enzyme Increased Consumer Depamide Supraventricular Health (Valpromide) C Extrasystoles Professional Ventricular Extrasystoles Other Weight Decreased 24-Jun-2005 12:19 PM Page: 1454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3759581-3Report Type:Expedited (15-DaCompany Report #US_010768992 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Health Zyprexa PS Eli Lilly And Co 5 MG/DAY Professional Company Representative Date:07/16/01ISR Number: 3759618-1Report Type:Expedited (15-DaCompany Report #US_010566275 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Arrest Foreign Zyprexa PS Eli Lilly And Co Health Prozac (Fluoxetine Professional Hydrohloride) SS Company Representative Other Date:07/16/01ISR Number: 3759812-XReport Type:Expedited (15-DaCompany Report #US_010768988 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Consumer Zyprexa PS Eli Lilly And Co 15 MG/DAY 3 MON Feeling Abnormal Prozac (Fluoxetine Insomnia Hydrochloride) SS Loss Of Consciousness Lithium C Road Traffic Accident Thirst Weight Increased Date:07/16/01ISR Number: 3759862-3Report Type:Expedited (15-DaCompany Report #US_010566281 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Hospitalization - Respiratory Arrest Health Prozac (Fluoxetine Initial or Prolonged Professional Hydrochloride) SS 40 MG/DAY Company Representative Other Date:07/16/01ISR Number: 3759864-7Report Type:Expedited (15-DaCompany Report #GBS010608956 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Fluid Retention Health Warfarin C International Normalised Professional Venlafaxine C Ratio Increased Company Priadel (Lithium Representative Carbonate) C Other Omeprazole C Efamast (Evening Primrose Oil) C 24-Jun-2005 12:19 PM Page: 1455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3759865-9Report Type:Expedited (15-DaCompany Report #DE_010606176 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Professional Other Date:07/16/01ISR Number: 3759962-8Report Type:Expedited (15-DaCompany Report #US_010768760 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ill-Defined Disorder Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Nausea Health Risperidone C Professional Biperiden C Company Etizolam C Representative Bio Three C Other Quazepam C Levomepromazine C Promethazine C Date:07/16/01ISR Number: 3759964-1Report Type:Expedited (15-DaCompany Report #US_010768853 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Multivitamins Nos Professional (Multivitamins Nos) C Company Representative Other Date:07/16/01ISR Number: 3759965-3Report Type:Expedited (15-DaCompany Report #DE_010706221 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Health Professional Other Date:07/16/01ISR Number: 3759967-7Report Type:Expedited (15-DaCompany Report #US_010768781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Vegetamin B C Professional Flunitrazepam C Company Nitrazepam C Representative Sennoside C Other Polycarbophil C 24-Jun-2005 12:19 PM Page: 1456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3760086-4Report Type:Expedited (15-DaCompany Report #US_010768692 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Zyprexa PS Eli Lilly And Co 10 MG / DAY Initial or Prolonged Speech Disorder Health Stupor Professional Company Representative Other Date:07/16/01ISR Number: 3760088-8Report Type:Expedited (15-DaCompany Report #US_010668361 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dialysis Foreign Zyprexa PS Eli Lilly And Co 10 MG / DAY Hospitalization - Drug Ineffective Health Risperidone C Initial or Prolonged Hallucination Professional Linton (Haloperidol) C Hallucination, Auditory Company Apiracohl Loss Of Consciousness Representative (Todralazine) C Pulmonary Fibrosis Other Pentona (Mazaticol Respiratory Failure Hydrochloride) C Suicide Attempt Diazepam C Vegetamin A C Rohypnol (Flunitrazepam) C Nifedipine C Bezatol - Slow Release (Bezafibrate) C Sennoside A C Date:07/16/01ISR Number: 3760090-6Report Type:Expedited (15-DaCompany Report #GBS010709053 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Foreign Zyprexa PS Eli Lilly And Co 40 MG / DAY Hospitalization - Congestive Cardiomyopathy Health Perindopril C Initial or Prolonged Echocardiogram Abnormal Professional Carbamazepine C Myositis Other Lofepramine C Lactulose C Date:07/16/01ISR Number: 3760093-1Report Type:Expedited (15-DaCompany Report #EWC010727518 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Zyprexa PS Eli Lilly And Co 7.5 MG DAY Initial or Prolonged Health Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 1457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3760094-3Report Type:Expedited (15-DaCompany Report #EWC010727498 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Chest Pain Health Fluvoxamine C Electrocardiogram Professional Levomepromazine C Abnormal Other Electrocardiogram Qrs Complex Abnormal Date:07/16/01ISR Number: 3760102-XReport Type:Expedited (15-DaCompany Report #AU_010703761 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemolytic Anaemia Foreign Zyprexa PS Eli Lilly And Co Health Professional Company Representative Other Date:07/16/01ISR Number: 3760104-3Report Type:Expedited (15-DaCompany Report #DE_010606189 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Increased Health Biperiden C Aspartate Professional Imipramin Aminotransferase Other (Imipramine Increased Hydrochloride) C Blood Creatine Lorazepam C Phosphokinase Increased Ranitidine C Diabetes Mellitus Metoprolol C Inadequate Control Actraphane Hm Gamma-Glutamyltransferase (Insulin Human Increased Injection, Isophane) C Sedation Urinary Tract Infection Date:07/16/01ISR Number: 3760107-9Report Type:Expedited (15-DaCompany Report #DE_010706257 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY White Blood Cell Count Health Decreased Professional Other Date:07/16/01ISR Number: 3760110-9Report Type:Expedited (15-DaCompany Report #DE_010706258 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Stangyl Professional (Trimipramine Other Maleate) C 24-Jun-2005 12:19 PM Page: 1458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3760115-8Report Type:Expedited (15-DaCompany Report #EWC010426464 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Increased Health Anaframil Aspartate Professional (Clomipramine Aminotransferase Other Hydrochloride) C Increased Stilnox (Zolpidem) C Gamma-Glutamyltransferase Alprazolam C Increased Buspirone Gynaecomastia Hydrochloride C Date:07/16/01ISR Number: 3760119-5Report Type:Expedited (15-DaCompany Report #EWC010526968 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Increased Health Aspartate Professional Aminotransferase Other Increased Date:07/16/01ISR Number: 3760123-7Report Type:Expedited (15-DaCompany Report #EWC010727505 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Increased Health Valproate Sodium C Aspartate Professional Lithium C Aminotransferase Company Increased Representative Gamma-Glutamyltransferase Other Increased Weight Increased Date:07/16/01ISR Number: 3760917-8Report Type:Expedited (15-DaCompany Report #EWC010727524 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Foreign Zyprexa PS Eli Lilly And Co 7.5 MG Dermatitis Health Professional Company Representative Other Date:07/16/01ISR Number: 3760919-1Report Type:Expedited (15-DaCompany Report #US_010668368 Age:69 YR Gender:Female I/FU:I Outcome PT Other Blood Pressure Decreased Bradycardia Coma Computerised Tomogram Abnormal Dizziness Faecal Incontinence 24-Jun-2005 12:19 PM Page: 1459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Pallor Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Haloperidol C Professional Company Representative Other Date:07/17/01ISR Number: 3759993-8Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Adderall 30 Mg PS ORAL 30 MG/ TWICE Hospitalization - Alopecia DAILY/ ORAL Initial or Prolonged Amnesia Zyprexia/ 5 Mg SS ORAL 5 MG/ Disability Delusion BEDTIME/ ORAL Insomnia Paranoia Psychotic Disorder Pyromania Suicidal Ideation Thinking Abnormal Weight Decreased Date:07/19/01ISR Number: 3761763-1Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Olanzapine (Lilly) PS Lilly ORAL 2.5MG AND 5MG PO Thiamine C Mvi C Folic Acid C Bupropion Sr C Ranitidine C Albuterol C Date:07/19/01ISR Number: 3762597-4Report Type:Expedited (15-DaCompany Report #NSADSS2001020630 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Haldol PS Rw Johnson Professional Pharmaceutical Research Institute Div Ortho Pharm Zyprexa (Olanzapine) SS ORAL ORAL Date:07/19/01ISR Number: 3762682-7Report Type:Expedited (15-DaCompany Report #DE_010706221 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co Health Professional Other 24-Jun-2005 12:19 PM Page: 1460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/01ISR Number: 3763452-6Report Type:Expedited (15-DaCompany Report #US_010464434 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Zyprexa PS Eli Lilly And Co 10 MG/1 IN Hospitalization - Injury Professional THE EVENING Initial or Prolonged Zoloft (Sertraline Hydrochloride) C Prolixin Decanoate(Fluphenazi ne Decanoate) C Date:07/23/01ISR Number: 3763503-9Report Type:Expedited (15-DaCompany Report #US_010769531 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cellulitis Health Zyprexa PS Eli Lilly And Co 10 MG/DAY 3 DAY Petechiae Professional Prozac (Fluoxetine Hydrochloride) SS Lithium C Cogentin (Benzatropine Mesilate) C Prevacid (Lansoprazole) C Date:07/23/01ISR Number: 3763504-0Report Type:Expedited (15-DaCompany Report #US_010769369 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Zyprexa PS Eli Lilly And Co International Normalised Professional Coumadin (Warfarin Ratio Increased Sodium) C Mouth Haemorrhage Cipro (Ciprofloxacin Hydrochloride) C Zoloft(Sertraline Hydrochloride) C Megace (Megestrol Acetate) C Date:07/23/01ISR Number: 3763528-3Report Type:Expedited (15-DaCompany Report #EWC010727622 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Neutropenia Health Loxapac (Loxapine Professional Succinate) C Other Date:07/23/01ISR Number: 3763529-5Report Type:Expedited (15-DaCompany Report #FR_010700080 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Leukopenia Foreign Pyrexia Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 1461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Eli Lilly And Co Prozac (Fluoxetine Hydrochloride) SS 20 MG/DAY Stilnox (Zolpidem) C Date:07/23/01ISR Number: 3763531-3Report Type:Expedited (15-DaCompany Report #EWC010727612 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co Initial or Prolonged Renal Failure Acute Health Efferalgan Professional (Paracetamol) C Other Rohypnol (Flunitrazepam) C Revia (Naltrexone) C Depakine (Valproate Sodium) C Date:07/23/01ISR Number: 3763532-5Report Type:Expedited (15-DaCompany Report #EWC010727607 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Professional Company Representative Other Date:07/23/01ISR Number: 3763534-9Report Type:Expedited (15-DaCompany Report #EWC010727598 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 10 MG/DAY Condition Aggravated Health Temesta (Lorazepam) C Drug Effect Decreased Professional Insomnia Other Leukopenia Date:07/23/01ISR Number: 3763536-2Report Type:Expedited (15-DaCompany Report #DE_010505818 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 2.5 MG/DAY Initial or Prolonged Hyperglycaemia Health Lanitop Upper Respiratory Tract Professional (Metildigoxin) C Infection Other Syntestan (Cloprednol) C Remergil (Mirtazapine) C Pulmicort Turbuhaler (Budesonide) C Berotec Inhaler (Fenoterol) C 24-Jun-2005 12:19 PM Page: 1462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium C Vigantoletten (Colecalciferol) C Godamed C Ampho Moronal "Bristol-Myers Squibb" (Amphotericin B) C Propycil (Propylthiouracil) C Rulid (Roxithromycin) C Kalinor (Potassium Chloride) C Date:07/23/01ISR Number: 3763538-6Report Type:Expedited (15-DaCompany Report #AU_010703853 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 10 MG/DAY Health Fluoxetine Professional (Fluoxetine Company Hydrochloride) SS 40 MG/DAY Representative Other Date:07/23/01ISR Number: 3763748-8Report Type:Expedited (15-DaCompany Report #US_010769559 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Phosphokinase Increased Health Haloperidol C Oedema Professional Chlorpromazine C Renal Failure Company Levomepromazine C Representative Griseofulvin C Other Date:07/23/01ISR Number: 3763749-XReport Type:Expedited (15-DaCompany Report #US_010769430 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Increased Appetite Health Serenace Insomnia Professional (Haloperidol) C Pruritus Company Akineton (Biperiden Speech Disorder Representative Hydrochloride) C Other Date:07/23/01ISR Number: 3763750-6Report Type:Expedited (15-DaCompany Report #US_010769393 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Eosinophilia Foreign Initial or Prolonged Neutrophilia Health Rash Erythematous Professional Rash Generalised Company Representative 24-Jun-2005 12:19 PM Page: 1463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5 MG/DAY Selbex (Teprenone) C Isomytal (Amobarbital) C Furosemide C Gaslon (Irsogladine Maleate) C Date:07/23/01ISR Number: 3763758-0Report Type:Expedited (15-DaCompany Report #US_010565287 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Carcinoma Health Zyprexa PS Eli Lilly And Co A FEW WEEKS Initial or Prolonged Professional Other Company Representative Date:07/23/01ISR Number: 3763759-2Report Type:Expedited (15-DaCompany Report #US_010566315 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Steatosis Health Zyprexa PS Eli Lilly And Co 5 MG / 1 DAY 2 YR Professional Adderall C Other Date:07/23/01ISR Number: 3763760-9Report Type:Expedited (15-DaCompany Report #US_010769249 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa PS Eli Lilly And Co 30 MG/DAY Increased Professional Trileptal Aspartate Company (Oxcarbazepine) C Aminotransferase Representative Increased Blood Sodium Decreased Oedema Overdose Platelet Count Decreased Date:07/23/01ISR Number: 3764066-4Report Type:Expedited (15-DaCompany Report #DE_010606023 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Decreased Health Aponal (Doxepin Influenza Like Illness Professional Hydrochloride) C Leukocytosis Other Isoptin Retard Lymphopenia (Verapamil Neutrophilia Hydrochloride) C Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/01ISR Number: 3764082-2Report Type:Expedited (15-DaCompany Report #DE_010706258 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Health Stagyl (Trimipramine Professional Meleate) C Other Date:07/23/01ISR Number: 3764083-4Report Type:Expedited (15-DaCompany Report #GBS010609044 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Impairment Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Neutropenia Health Citolopram C Professional Company Representative Other Date:07/23/01ISR Number: 3764084-6Report Type:Expedited (15-DaCompany Report #GBS010609026 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa PS Eli Lilly And Co Panic Reaction Health Prozac (Fluxetine Renal Haemorrhage Professional Hydrochloride) SS Sepsis Company Suicide Attempt Representative Other Date:07/23/01ISR Number: 3764092-5Report Type:Expedited (15-DaCompany Report #EWC010627158 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Zyprexa PS Eli Lilly And Co 20 MG 2 YR Initial or Prolonged Blood Alkaline Health Tegretol Phosphatase Increased Professional (Carbamazepine) C Blood Creatine Other Kemadrin Phosphokinase Mb (Procyclidine Increased Hydrochloride) C Muscular Weakness Chlorpromazine C Myalgia Date:07/23/01ISR Number: 3764097-4Report Type:Expedited (15-DaCompany Report #US_010768781 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Increased Health Vegetamin B C Aspartate Professional Flunitrazepam C Aminotransferase Company Nitrazepam C Increased Representative Sennoside C Blood Alkaline Other Polycarbophil Phosphatase Increased Calcium C Blood Bilirubin Increased Jaundice 24-Jun-2005 12:19 PM Page: 1465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/01ISR Number: 3764887-8Report Type:Expedited (15-DaCompany Report #US_010769189 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Increased Health Aspartate Professional Aminotransferase Company Increased Representative Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Leukopenia Date:07/23/01ISR Number: 3764898-2Report Type:Expedited (15-DaCompany Report #US_010769267 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Syndrome Health Tolopelon Pneumonia Aspiration Professional (Timiperone) C Respiratory Failure Company Tasmolin (Biperiden) C Representative Symmetrel (Amantadine Hydrochloride) C Pantosin (Pathethine) C Magnesium Oxide C Doral (Quazepam) C Brovarin (Bromisoval) C Date:07/26/01ISR Number: 3766176-4Report Type:Expedited (15-DaCompany Report #A117130 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Geodon PS Pfizer Central Initial or Prolonged Difficulty In Walking Research ORAL 120.00 MG Drug Interaction TOTAL: Drug Level Above BIID:ORAL Therapeutic Lithium SS ORAL 1600.00 MG Hallucination TOTAL: DAILY: ORAL Zyprexa (Olanzapine) SS ORAL 30.00 MG TOTAL: DAILY:ORAL Tegretol (Carbamazepine) SS ORAL ORAL Sleeping Medication C Blood Pressure Medication C Date:07/27/01ISR Number: 3766600-7Report Type:Direct Company Report # Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Zyprexa SS 24-Jun-2005 12:19 PM Page: 1466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/01ISR Number: 3766718-9Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Ketone Body Zyprexa 10mg PS ORAL HS PO Intervention to Dry Mouth Lithium Carbonate C Prevent Permanent Hyperglycaemia Benadryl C Impairment/Damage Hypomania Depakote C Increased Appetite Prolixin C Insomnia Lethargy Pollakiuria Sedation Weight Increased Date:07/30/01ISR Number: 3767651-9Report Type:Expedited (15-DaCompany Report #US_010667057 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Permax PS Eli Lilly And Co 0.25 MG/2 DAY Pericardial Effusion Professional Zyprexa (Olanzapine) SS Other Mysoline (Primidone) C Propranolol C Lasix (Furosemide) C K-Dur (Potassium Chloride) C Date:07/30/01ISR Number: 3767653-2Report Type:Expedited (15-DaCompany Report #US_010768791 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Zyprexa PS Eli Lilly And Co 5 MG/2 DAY Initial or Prolonged Blood Bilirubin Increased Professional Chromaturia Dyspnoea Haemoglobin Decreased Hepatic Encephalopathy Prothrombin Level Increased Pyrexia Tachycardia Vomiting Date:07/30/01ISR Number: 3767655-6Report Type:Expedited (15-DaCompany Report #US_010565379 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Hallucination, Auditory Health Lithium C Mania Professional Suicide Attempt Date:07/30/01ISR Number: 3767706-9Report Type:Expedited (15-DaCompany Report #US_010463552 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 1467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/01ISR Number: 3767907-XReport Type:Expedited (15-DaCompany Report #US_010769797 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Zyprexa PS Eli Lilly And Co Professional Date:07/30/01ISR Number: 3767940-8Report Type:Expedited (15-DaCompany Report #US_010565439 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alveolitis Allergic Health Zyprexa PS Eli Lilly And Co 1 YR Antibody Test Positive Professional Lithium (Amfebutamone Hydrochloride) C Date:07/30/01ISR Number: 3768300-6Report Type:Expedited (15-DaCompany Report #US_010769550 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa PS Eli Lilly And Co Other Ketoacidosis Professional Company Representative Date:07/30/01ISR Number: 3768302-XReport Type:Expedited (15-DaCompany Report #US_010770010 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa PS Eli Lilly And Co 5 MG/DAY Dysarthria Procardia Xl Dysphemia (Nifedipine) C Staring Date:07/30/01ISR Number: 3768350-XReport Type:Expedited (15-DaCompany Report #US_010769534 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Health Zyprexa PS Eli Lilly And Co 180 MG/DAY Overdose Professional Company Representative Date:07/30/01ISR Number: 3768730-2Report Type:Expedited (15-DaCompany Report #EWC010325786 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Health Professional Other 24-Jun-2005 12:19 PM Page: 1468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/01ISR Number: 3768732-6Report Type:Expedited (15-DaCompany Report #DE_010606027 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Hypersensitivity Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY White Blood Cell Count Health Remergil Decreased Professional (Mirtazapine) C Other Atosil (Isopromethazine Hydrochloride0 C Ximovan (Zopiclone) C Ass C Lopirin (Captopril) C Bronchoretard (Theophylline) C Magnesium Verla (Magnesium Hydrogen Aspartate) C Pulmicort (Budesonide) C Atrovent (Ipratropium Bromide) C Sortis (Atorvastatin Calcium) C Tavor (Lorazepam) C Edronax (Reboxetine) C Amoxihexal (Amoxicillin Trihydrate) C Zoloft (Sertraline Hydrochloride) C Date:07/30/01ISR Number: 3769054-XReport Type:Expedited (15-DaCompany Report #EWC010727683 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Professional Other Date:07/30/01ISR Number: 3769055-1Report Type:Expedited (15-DaCompany Report #EWC010727658 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eclampsia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Urinary Tract Infection Health Nibiol (Nitroxoline) C Professional Company Representative Other Date:07/30/01ISR Number: 3769057-5Report Type:Expedited (15-DaCompany Report #CA_010704014 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Hypothermia Foreign Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 1469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 10 MG Date:07/30/01ISR Number: 3769058-7Report Type:Expedited (15-DaCompany Report #GBS010709135 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Coronary Artery Disease Health Co-Codamol C Dyspnoea Professional Synflex (Naproxen Mouth Haemorrhage Other Sodium) C Overdose Ibuprofen C Pulmonary Oedema Duovent C Toxicologic Test Abnormal Ventricular Hypertrophy Date:07/30/01ISR Number: 3769060-5Report Type:Expedited (15-DaCompany Report #EWC010727693 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extensor Plantar Response Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Initial or Prolonged Paresis Health Professional Other Date:07/30/01ISR Number: 3769077-0Report Type:Expedited (15-DaCompany Report #EWC010727733 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Increased Health Deroxat (Paroxetine Aspartate Professional Hydrochloride) C Aminotransferase Company Increased Representative Blood Lactate Other Dehydrogenase Increased Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Platelet Disorder Weight Increased Date:07/30/01ISR Number: 3769078-2Report Type:Expedited (15-DaCompany Report #GBS010609026 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co Intentional Misuse Health Prozac (Fluoxetine Mental Impairment Professional Hydrochloride) SS Panic Reaction Company Renal Haemorrhage Representative Toxicologic Test Abnormal Other Vomiting 24-Jun-2005 12:19 PM Page: 1470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/01ISR Number: 3769079-4Report Type:Expedited (15-DaCompany Report #US_010769267 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Neuroleptic Malignant Health Tolopelon Syndrome Professional (Timiperone) C Pneumonia Aspiration Company Tasmolin (Biperiden) C Respiratory Failure Representative Symmetrel Other (Amantadine Hydrochloride) C Pantosin (Pantethine) C Magnesium Oxide C Doral (Quazepam) C Brovarin (Bromisoval) C Date:07/31/01ISR Number: 3768508-XReport Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Mass Zyprexa - Eli Lilly PS Eli Lilly ORAL 5MG QHS PO Breast Pain Date:08/01/01ISR Number: 3768456-5Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Olanzapine (15mg) PS Initial or Prolonged Date:08/07/01ISR Number: 3771696-2Report Type:Expedited (15-DaCompany Report #US_010770342 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa PS Eli Lilly And Co 20 MG/DAY Professional Depakote (Valproate Company Semisodium) C Representative Haldol (Haloperidol) C Date:08/07/01ISR Number: 3771713-XReport Type:Expedited (15-DaCompany Report #US_010770038 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Zyprexa PS 450 MG/DAY Dizziness Professional Xanax (Alprazolam) C Intentional Misuse Restoril (Temazepam) C Kyphosis Inderal (Propranolol Speech Disorder Hydrochloride) C Date:08/07/01ISR Number: 3771715-3Report Type:Expedited (15-DaCompany Report #US_010770169 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Zyprexa PS 40 MG/DAY Initial or Prolonged Professional Kemadrin 24-Jun-2005 12:19 PM Page: 1471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Procyclidine Hydrochloride) C Aricept (Donepezil Hydrochloride0 C Prilosec (Omeprazole) C Amantadine C Buspar (Buspirone Hydrochloride) C Date:08/07/01ISR Number: 3771717-7Report Type:Expedited (15-DaCompany Report #US_010770346 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa PS 40 MG/DAY Professional Depakote (Valproate Company Semisodium) C Representative Haldol (Haloperidol) C Date:08/07/01ISR Number: 3771728-1Report Type:Expedited (15-DaCompany Report #US_010566366 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Health Zyprexa (Olanzapine) PS Eli Lilly And Co 15 MG/ 1 DAY Increased Professional Depakote (Valproate Semisodium) C Adderall C Date:08/07/01ISR Number: 3771730-XReport Type:Expedited (15-DaCompany Report #US_010666906 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombotic Health Zyprexa (Olanzapine) PS Eli Lilly And Co Thrombocytopenic Purpura Professional Company Representative Date:08/07/01ISR Number: 3771792-XReport Type:Expedited (15-DaCompany Report #US_010770382 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Difficulty In Walking Consumer Zyprexa PS Eli Lilly And Co 10 MG/DAY Date:08/07/01ISR Number: 3771793-1Report Type:Direct Company Report # Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Zyprexa PS ORAL QD PO Diabetic Coma Nervousness 24-Jun-2005 12:19 PM Page: 1472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/01ISR Number: 3772055-9Report Type:Expedited (15-DaCompany Report #CA_010704029 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalitis Viral Foreign Zyprexa PS Eli Lilly And Co 10 MG/1 AT Initial or Prolonged Hypokalaemia Health BEDTIME Other Meningitis Professional Premarin (Estrogens Neuroleptic Malignant Other Conjugated) C Syndrome Glucophage (Metformin Hydrochloride0 C Provera (Medroxyprogesterone Acetate) C Ativan (Lorazepam) C Zocor (Simvastatin0 C Celexa (Citalopram Hydrobromide) C Date:08/07/01ISR Number: 3772058-4Report Type:Expedited (15-DaCompany Report #DE_010606189 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Aminotransferase Health Biperidin C Increased Professional Imipramin(Imipramin Blood Creatine Other Hydrochloride) C Phosphokinase Increased Ranitidine C Diabetes Mellitus Metoprolol C Gamma-Glutamyltransferase Acraphane Hm(Insulin Increased Human Injection, Pyrexia Isophane) C Urinary Tract Infection Date:08/07/01ISR Number: 3772145-0Report Type:Expedited (15-DaCompany Report #DE_010606176 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Schizophrenia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Thrombocytopenia Health Professional Other Date:08/07/01ISR Number: 3772151-6Report Type:Expedited (15-DaCompany Report #FR_010700095 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Tercian(Cyamemazine) C Professional Other Date:08/07/01ISR Number: 3772152-8Report Type:Expedited (15-DaCompany Report #US_010770461 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Death Completed Suicide Foreign Health 24-Jun-2005 12:19 PM Page: 1473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 10 MG/DAY Fluphenaziine Decanoate C Date:08/07/01ISR Number: 3772153-XReport Type:Expedited (15-DaCompany Report #US_010770302 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Other Water Intoxication Health Tasmolin (Biperiden) C Professional Etilefrine C Company Pentona (Mazaticol Representative Hydrochloride) C Other Valerin (Valproate Sodium) C Rohypnol(Flunitrazep am) C Nelbon(Nitrazepam) C Hirnamin ( Levomepromazine) C Pursennid (Senna Leaf) C Eurodin (Estazolam) C Alosenn C Solita T C Barnetil (Sultopride) C Impromen (Bromperidol) C Date:08/07/01ISR Number: 3772158-9Report Type:Expedited (15-DaCompany Report #EWC010627170 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Foreign Zyprexa PS Eli Lilly And Co Ecchymosis Health Thyrax Eosinophilia Professional (Levothyroxine) C Fall Other Lorazepam C Haematoma Priadel (Lithium Leukocytosis Carbonate) C Movement Disorder Nortrilen Pain In Extremity (Nortriptyline Swelling Hydrochloride) C Thrombocythaemia Losec (Omeprazole) C Adalat (Nifedipine) C Formoterol C Flixotide (Fluticasone Propionate) C 24-Jun-2005 12:19 PM Page: 1474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/01ISR Number: 3772196-6Report Type:Expedited (15-DaCompany Report #US_010769393 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Neutrophilia Health Selbex(Teprenone) C Rash Erythematous Professional Isomytal Rash Generalised Company (Am0barbital) C Representative Furosemide C Other Gaslon (Irsogladine Maleate) C Date:08/09/01ISR Number: 3775387-3Report Type:Expedited (15-DaCompany Report #US_010871008 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Eli Lilly And Co 1 DAY Professional Company Representative Date:08/10/01ISR Number: 3779966-9Report Type:Periodic Company Report #PHEH2001US06136 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Trileptal PS Novartis Increased Professional Pharmaceuticals Corp ORAL 900 MG, TID, Aspartate Company ORAL Aminotransferase Representative Zyprexa (Olanzapine) SS ORAL 30 MG, QD, Increased ORAL Blood Sodium Decreased Celexa (Citalopram Blood Urea Decreased Hydrobromide) SS ORAL 40 MG, QD, Neutrophil Count ORAL Decreased Oedema Peripheral Platelet Count Decreased Red Blood Cell Count Decreased White Blood Cell Count Decreased Date:08/13/01ISR Number: 3775110-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Zyprexa 7.5 Mg Lilly PS ORAL 7.5 MG HS Initial or Prolonged ORAL Haloperidol 5 Mg SS ORAL 5 MG TID PO Quetiapine C Date:08/13/01ISR Number: 3775992-4Report Type:Expedited (15-DaCompany Report #US_010666906 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombotic Health Zyprexa (Olanzapine) PS Eli Lilly And Co Thrombocytopenic Purpura Professional Company Representative 24-Jun-2005 12:19 PM Page: 1475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/01ISR Number: 3775994-8Report Type:Expedited (15-DaCompany Report #US_010769369 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Health Zyprexa (Olanzapine) PS Eli Lilly And Co Initial or Prolonged International Normalised Professional Coumadin (Warfarin Other Ratio Increased Sodium) C Mouth Haemorrhage Cipro (Ciprofloxacin Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Megace (Megestrol Acetate) C Date:08/13/01ISR Number: 3776014-1Report Type:Expedited (15-DaCompany Report #US_010565562 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombotic Health Zyprexa PS Eli Lilly And Co 10 MG/DAY 1 YR Initial or Prolonged Thrombocytopenic Purpura Professional Metoprolol C Company Zocor (Simvastatin) C Representative Clonidine C Synthroid (Levothyroxine Sodium) C Date:08/13/01ISR Number: 3776138-9Report Type:Expedited (15-DaCompany Report #US_010870685 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atelectasis Health Fluoxetine Hcl PS Lilly Research Oedema Peripheral Professional Laboratories Div Eli Overdose Lilly And Co 90 MG/DAY Zyprexa (Olanzapine) SS 5 MG/DAY 2 MON Amitriptyline C Alprazolam C Date:08/13/01ISR Number: 3776331-5Report Type:Expedited (15-DaCompany Report #US_010870762 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zyprexa PS Eli Lilly And Co Drug Toxicity Professional Celexa (Citalopram Hydrobromide) C Date:08/13/01ISR Number: 3776334-0Report Type:Expedited (15-DaCompany Report #US_010770512 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Depigmentation Health Zyprexa PS Eli Lilly And Co 3 MON Professional Ortho Cyclen C Methylphenidate C Klonopin (Clonazepam) C Luvox (Fluvoxamine Maleate) C 24-Jun-2005 12:19 PM Page: 1476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/01ISR Number: 3776487-4Report Type:Expedited (15-DaCompany Report #DE_010706257 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY White Blood Cell Count Health Decreased Professional Other Date:08/13/01ISR Number: 3776490-4Report Type:Expedited (15-DaCompany Report #US_010870923 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Health Professional Company Representative Other Date:08/13/01ISR Number: 3776491-6Report Type:Expedited (15-DaCompany Report #US_010870787 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Injury Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Other Lower Limb Fracture Health Risperdal Pelvic Fracture Professional (Risperidone) C Spinal Fusion Acquired Company Contomin Stress Representative (Chlorpromazine Suicidal Ideation Other Hydrochloride) C Suicide Attempt Haloperidol C Date:08/13/01ISR Number: 3776492-8Report Type:Expedited (15-DaCompany Report #US_010770244 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Initial or Prolonged Delusion Health Levomepromazine C Weight Decreased Professional Company Representative Other Date:08/13/01ISR Number: 3776493-XReport Type:Expedited (15-DaCompany Report #GBS010809222 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Abnormal Health Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 1477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/01ISR Number: 3776494-1Report Type:Expedited (15-DaCompany Report #GBS010709210 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Health Piportil Depot Professional (Pipotiazine Other Palmitate) C Date:08/13/01ISR Number: 3776495-3Report Type:Expedited (15-DaCompany Report #GBS010709207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Dyspepsia Health Depixol (Flupentixol Headache Professional Decanoate) C Joint Stiffness Other Pain Date:08/13/01ISR Number: 3776496-5Report Type:Expedited (15-DaCompany Report #GBS010709193 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Complications Of Maternal Health Sertraline C Exposure To Therapeutic Professional Drugs Other Extrapyramidal Disorder Feeling Jittery Neonatal Disorder Premature Baby Date:08/13/01ISR Number: 3776497-7Report Type:Expedited (15-DaCompany Report #EWC010727779 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Tuberculosis Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY 2 YR Hospitalization - Sudden Death Health Initial or Prolonged Professional Other Date:08/13/01ISR Number: 3776498-9Report Type:Expedited (15-DaCompany Report #DE_010706416 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Neutropenia Health Clozapine C Professional .. C Other Date:08/13/01ISR Number: 3776521-1Report Type:Expedited (15-DaCompany Report #US_010768692 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Ileus Paralytic Foreign Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 10 MG/DAY Date:08/13/01ISR Number: 3776524-7Report Type:Expedited (15-DaCompany Report #US_010769430 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Increased Appetite Health Serenace Insomnia Professional (Haloperidol) C Pruritus Company Akineton (Biperiden Speech Disorder Representative Hydrochloride) C Weight Increased Other Date:08/13/01ISR Number: 3776526-0Report Type:Expedited (15-DaCompany Report #US_010770461 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Refusal Of Treatment By Health Fluphenazine Relative Professional Decanoate C Company Biperiden Representative Hydrochloride C Other Cloxazolam C Quazepam C Date:08/13/01ISR Number: 3776919-1Report Type:Expedited (15-DaCompany Report #US_010769393 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Neutrophilia Health Selbex (Teprenone) C Rash Erythematous Professional Isomytal White Blood Cell Count Company (Amobarbital) C Increased Representative Furosemide C Other Gaslon (Irsogladine Maleate) C Date:08/13/01ISR Number: 3776921-XReport Type:Expedited (15-DaCompany Report #EWC010727683 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Injury Asphyxiation Health Professional Other Date:08/14/01ISR Number: 3777277-9Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome Other Required Intervention to 24-Jun-2005 12:19 PM Page: 1479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Zyprexa 20 Mg 1 X Daily PS ORAL 20 MG 1 X DAILY BY MOUTH Date:08/14/01ISR Number: 3780181-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Zyprexa PS Date:08/16/01ISR Number: 3778488-9Report Type:Direct Company Report # Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Zyprexa PS Fall Gait Disturbance Date:08/16/01ISR Number: 3779086-3Report Type:Expedited (15-DaCompany Report #01P-163-0103471-00 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Kaletra PS Abbott Laboratories ORAL PER ORAL Initial or Prolonged Diabetic Ketoacidosis Professional Olanzapine SS Mania Combivir C Ketoconazole C Phenytoin Sodium C Date:08/17/01ISR Number: 3779708-7Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Olanzapine PS ORAL 25MG PO BID Initial or Prolonged Aspirin C Excedrin C Atenolol C Clotrimazole C Cyclobenzaprine C Ibuprofen C Lorazepam C Niacin C Oxazepam C Simvastatin C Vit E C Date:08/17/01ISR Number: 3780087-XReport Type:Expedited (15-DaCompany Report #A112903 Age:29 YR Gender:Female I/FU:F Outcome PT Death Completed Suicide Glomerulonephritis Membranoproliferative 24-Jun-2005 12:19 PM Page: 1480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Toxicologic Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon PS Pfizer Central Health Research ORAL 20.00 MG Professional TOTAL: BID: ORAL Hydrocodone SS Olanzapine SS Clonazepam C Promethazine C Zestril C Prevacid C Acetominophen C Lorazepam C Albuterol Inhaler C Levora C Celexa C Triazolan C Ambien C Ibuprofen C Aerobid-M C Daypro C Date:08/20/01ISR Number: 3780394-0Report Type:Direct Company Report # Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Zyprexa 5mg Lily PS Lily ORAL 5MG ONCE Initial or Prolonged Prolonged DAILY ORAL Celexa C Norvasc C Ambien C Premarin C Cozaar C Levothyroxine C Propranolol C Ritalin C Potassium Chloride C Percocet C Lasix C Date:08/20/01ISR Number: 3780594-XReport Type:Expedited (15-DaCompany Report #US_010769189 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Hepatic Function Abnormal Health Tasmolin (Biperiden) C Leukopenia Professional Nasopharyngitis Company Sedation Representative Other 24-Jun-2005 12:19 PM Page: 1481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/01ISR Number: 3780600-2Report Type:Expedited (15-DaCompany Report #EWC010627325 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Thrombocytopenia Health Loxapac (Loxapine Professional Succinate) C Other Date:08/20/01ISR Number: 3780602-6Report Type:Expedited (15-DaCompany Report #CA_010804103 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Complications Of Maternal Consumer Exposure To Therapeutic Other Drugs Pregnancy Date:08/20/01ISR Number: 3780603-8Report Type:Expedited (15-DaCompany Report #DE_990501177 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY 4 WK Health Ergenyl (Valproate Professional Sodium) C Other Date:08/20/01ISR Number: 3780702-0Report Type:Expedited (15-DaCompany Report #US_0108712166 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Other Phosphokinase Increased Health Contomin Dysphagia Professional (Chlorpromazine Neuroleptic Malignant Company Hydrochloride) C Syndrome Representative Vegetamin A C Pneumonia Other Benzalin (Nitrazepam) C Brotizolam C Cabaser (Cabergoline) C Haloperidol C Trihexyphenidyl C Rohypnol (Flunitrazepam) C Date:08/20/01ISR Number: 3780704-4Report Type:Expedited (15-DaCompany Report #US_010769393 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa PS Eli Lilly And Co 5 MG/DAY Initial or Prolonged Neutrophilia Health Selbex (Teprenone) C Rash Erythematous Professional Isomytal Rash Generalised Company (Amobarbital) C White Blood Cell Count Representative Furosemide C Increased Other Gaslon (Irsogladine Maleate) C 24-Jun-2005 12:19 PM Page: 1482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/01ISR Number: 3780708-1Report Type:Expedited (15-DaCompany Report #EWC001208977 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged White Blood Cell Count Health Previscan Decreased Professional (Fluindione) C Other Fer "Ucb" (Ferrous Chloride) C Innohep (Heparin-Fraction, Sodium Salt) C Date:08/20/01ISR Number: 3780711-1Report Type:Expedited (15-DaCompany Report #US_010870787 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haemorrhage Foreign Zyprexa PS Eli Lilly And Co 15 MG/DAY Other Lower Limb Fracture Health Risperdal Pelvic Fracture Professional (Risperidone) C Spinal Fracture Company Contomin Suicidal Ideation Representative (Chlorpromazine Suicide Attempt Other Hydrochloride) C Haloperidol C Akineton (Biperiden Hydrochloride) C Amoban (Zopiclone) C Date:08/20/01ISR Number: 3780732-9Report Type:Expedited (15-DaCompany Report #US_010668286 Age:50 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Zyprexa (Olanzapine) PS 20 MG/AT Life-Threatening Cholelithiasis BEDTIME Hospitalization - Gastric Haemorrhage Hydrocodone Initial or Prolonged Haematocrit Decreased W/Acetaminophen C Haemoglobin Decreased Klonopin Pulmonary Congestion (Clonazepam) C Pulmonary Oedema Depakote (Valpraote Semisodium) C Date:08/20/01ISR Number: 3780764-0Report Type:Expedited (15-DaCompany Report #GBS010809244 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS Eli Lilly And Co Health Professional Company Representative Other Date:08/20/01ISR Number: 3780765-2Report Type:Expedited (15-DaCompany Report #US_010871019 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Drug Effect Decreased Health Initial or Prolonged Weight Increased Professional 24-Jun-2005 12:19 PM Page: 1483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co Date:08/20/01ISR Number: 3780766-4Report Type:Expedited (15-DaCompany Report #EWC010827940 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Walking Foreign Zyprexa PS Eli Lilly And Co 10 MG/DAY Health Fluoxetine(Fluxetine Professional Hydrochloride) SS 40 MG/DAY Company Representative Distributor Other Date:08/20/01ISR Number: 3780768-8Report Type:Expedited (15-DaCompany Report #EWC010827934 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Middle Insomnia Foreign Zyprexa PS Eli Lilly And Co 20 MG/DAY Sleep Walking Health Fluxetine(Fluoxetine Professional Hydrochloride) SS 30 MG/DAY Company Representative Other Date:08/20/01ISR Number: 3780796-2Report Type:Expedited (15-DaCompany Report #DE_010806483 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Zyprexa PS Eli Lilly And Co Initial or Prolonged Bladder Disorder Health Digoxin C Other Bradycardia Professional Sotalol C Depressed Level Of Other Acetylsalicylic Acid C Consciousness Captopril C Dysphagia Risperidone C Extrapyramidal Disorder Promethazine C Malnutrition Urinary Retention Date:08/20/01ISR Number: 3780909-2Report Type:Expedited (15-DaCompany Report #GBS010809222 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Foreign Zyprexa PS Eli Lilly And Co 15 MG / 1 DAY Corrected Interval Health Paroxetine C Prolonged Professional Sudden Death Other 24-Jun-2005 12:19 PM Page: 1484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/01ISR Number: 3780910-9Report Type:Expedited (15-DaCompany Report #EWC010727518 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Zyprexa PS Eli Lilly And Co 7.5 MG/DAY Initial or Prolonged Oedema Peripheral Health Depamide Professional (Valpromide) C Company Athymil (Mianserin Representative Hydrochloride) C Other Xanax (Alprazolam) C Date:08/20/01ISR Number: 3780911-0Report Type:Expedited (15-DaCompany Report #EWC010526821 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Foreign Zyprexa PS Eli Lilly And Co 20 MG DAY Blood Pressure Systolic Consumer Depamide Increased Health (Valpromide) C Hepatic Enzyme Increased Professional Aspirin C Stress Other Supraventricular Extrasystoles Ventricular Extrasystoles Weight Decreased Date:08/20/01ISR Number: 3780912-2Report Type:Expedited (15-DaCompany Report #EWC010526684 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa PS Eli Lilly And Co 5 MG/ 1DAY 2 DAY Hospitalization - Confusional State Health Hypertensive C Initial or Prolonged Professional Antidepressant C Other Date:08/20/01ISR Number: 3780962-6Report Type:Periodic Company Report #PHEH2001US03174 Age:97 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Exelon PS Novartis Blood Pressure Decreased Professional Pharmaceuticals Corp ORAL 1.5 MG, BID, Confusional State ORAL Disorientation Olanzapine Heart Rate Decreased (Olanzapine) SS 3 DAY Syncope Lorazepam (Lorazepam) SS 3 DAY Anihypertensive Drugs (No Ingredients/Substanc es) SS Acetylsalicylic Acid C Furosemide C Levothyroxine (Levothyroxine) C 24-Jun-2005 12:19 PM Page: 1485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/01ISR Number: 3780428-3Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Olanzapine PS ORAL 5 MG/ BID/ ORAL Date:08/22/01ISR Number: 3782065-3Report Type:Expedited (15-DaCompany Report #US_010870695 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Infarction Foreign Zyprexa(Olanzapine) PS 10 MG/DAY Dysphagia Health Electroencephalogram Professional Abnormal Company Extrapyramidal Disorder Representative Muscle Rigidity Other Stupor Waxy Flexibility Date:08/22/01ISR Number: 3782117-8Report Type:Expedited (15-DaCompany Report #A119351 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zoloft PS ORAL 150.00 MG Initial or Prolonged Blood Sodium Decreased Professional TOTAL:DAILY:O Required Convulsion RAL Intervention to Fall Zyprexa SS Prevent Permanent Lethargy Vasotec C Impairment/Damage Memory Impairment Albuterol Inhaler C Psychotic Disorder Water Intoxication Date:08/24/01ISR Number: 3783242-8Report Type:Expedited (15-DaCompany Report #PERCOCET2001-00222 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Percocet Endo PS Endo ORAL 15 TABS UKN Brain Oedema Professional PO Cardiomegaly Olanzapine SS Coronary Artery Disease Propoxyphene SS Drug Level Above Fluoxetine SS Therapeutic Chlorpromazine SS Drug Toxicity Caffeine SS Hepatic Congestion Hepatic Steatosis Pulmonary Congestion Pulmonary Haemorrhage Date:08/27/01ISR Number: 3783413-0Report Type:Expedited (15-DaCompany Report #US_010871684 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa (Olanzapine) PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 1486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/01ISR Number: 3783544-5Report Type:Expedited (15-DaCompany Report #US_010871462 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Disorder Health Zyprexa (Olanzapine) PS Eli Lilly 5 MG/DAY Initial or Prolonged Pneumonia Professional Company Representative Date:08/27/01ISR Number: 3783594-9Report Type:Expedited (15-DaCompany Report #US_001154483 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Consumer Zyprexa (Olanzapine) PS 5 MG/DAY Weight Increased Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Metoprolol C Levothyroxine C Effexor (Venlafaxine Hydrochloride) C Celexa (Citalopram Hydrobromide) C Date:08/27/01ISR Number: 3783667-0Report Type:Expedited (15-DaCompany Report #DE_010606027 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Decreased Health Remergil Professional (Mirtazapine) C Other Atosil(Isopromethaz ine Hydrochloride) C Ass C Lopirin (Captopril) C Bronchoretard (Theophylline) C Magnesium Verla (Magnesium Hydrogen Aspartate) C Pulmicort (Budesonide) C Atrovent (Ipratropium Bromide) C Sortis (Atorvastatin Calcium) C Tavor (Lorazepam) C Edronax (Reboxetine) C Amoxihexal (Amoxicillin Trihydrate) C Zoloft (Sertraline Hydrochloride) C Ximovan(Zopiclone) C 24-Jun-2005 12:19 PM Page: 1487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/01ISR Number: 3783668-2Report Type:Expedited (15-DaCompany Report #EWC010426475 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Anaemia Health Lexomil (Bromazepam) C Lower Respiratory Tract Professional Akineton (Biperiden Infection Company Hydrochloride) C Pyrexia Representative Xanax (Alprazolam) C Other Stilnox (Zolpidem) C Date:08/27/01ISR Number: 3783770-5Report Type:Expedited (15-DaCompany Report #EWC010827993 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Radiotherapy C Professional Date:08/27/01ISR Number: 3783771-7Report Type:Expedited (15-DaCompany Report #EWC010828015 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Health Rexer (Mirtazapine) C Professional Other Date:08/27/01ISR Number: 3783772-9Report Type:Expedited (15-DaCompany Report #DE_010806485 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa (Olanzapine) PS 5 MG/2 DAY Condition Aggravated Health Sifrol (Pramipexole Hypertension Professional Dihydrochloride) C Pancytopenia Other Madopar Depot C Potassium C Dopergin (Lisuride Maleate) C Zyloric (Allopurinol) C Bazoton (Urtica Extract) C Arelix (Piretanide) C Sandocal (Calcium Glubionate) C Norvasc (Amlodipine Besilate) C Eunerpan (Melperone Hydrochloride) C Date:08/27/01ISR Number: 3783773-0Report Type:Expedited (15-DaCompany Report #GBS010809301 Age:45 YR Gender:Male I/FU:I Outcome PT Other Condition Aggravated Lymphocyte Count Decreased 24-Jun-2005 12:19 PM Page: 1488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophil Count Decreased Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 40 MG/DAY Health Lorazepam C Professional Other Date:08/27/01ISR Number: 3783799-7Report Type:Expedited (15-DaCompany Report #DE_010606023 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Leukocytosis Health Aponal (Doxepin Professional Hydrochloride) C Other Isoptin Retard (Verapamil Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:08/27/01ISR Number: 3783800-0Report Type:Expedited (15-DaCompany Report #US_010870923 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Serenace Professional (Haloperidol) C User Facility Akineton (Biperiden Other Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Depas (Etizolam) C Lendormin (Brotizolam) C Date:08/27/01ISR Number: 3783865-6Report Type:Expedited (15-DaCompany Report #US_010871705 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Other Diabetes Mellitus Health Diabinese Diabetic Coma Professional (Chlorpropamide) C Other Date:08/27/01ISR Number: 3783866-8Report Type:Expedited (15-DaCompany Report #US_010871419 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Other Depressed Level Of Health Seroquel C Consciousness Professional Contomin Dyspnoea Company (Chlorpromazine Neuroleptic Malignant Representative Hydrochloride) C Syndrome Other Serenace (Haloperidol) C 24-Jun-2005 12:19 PM Page: 1489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/01ISR Number: 3783867-XReport Type:Expedited (15-DaCompany Report #EWC010827988 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Anafranil Professional (Clomipramine Other Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Seresta (Oxazepam) C Rivotril (Clonazepam) C Tercian (Cyamemazine) C Akineton (Biperiden Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Imovane (Zopiclone) C Levothyrox (Levothyroxine Sodium) C Hypothyroidism C Date:08/27/01ISR Number: 3783868-1Report Type:Expedited (15-DaCompany Report #GBS010809299 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY Increased Health Procyclidine C Blood Alkaline Professional Lactulose C Phosphatase Increased Other Tibolone C Blood Bilirubin Increased Lorazepam C Hepatic Function Abnormal Date:08/27/01ISR Number: 3783869-3Report Type:Expedited (15-DaCompany Report #GBS010809297 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorgasmia Foreign Zyprexa (Olanzapine) PS 10M G/DAY Erectile Dysfunction Health Loss Of Libido Professional Other Date:08/28/01ISR Number: 3783334-3Report Type:Direct Company Report # Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Olanzapine 2.5mg PS ORAL 2.5MG TID ORAL Sertraline 100mg SS ORAL 50MG QAM ORAL 24-Jun-2005 12:19 PM Page: 1490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/01ISR Number: 3785146-3Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Seroquel (Astra Neuroleptic Malignant Zeneca) Quetiapine Syndrome Fumarate PS Astra Zeneca Rhabdomyolysis Zyprexa(Lilly) Thienobenzodiazepine SS Lilly PTA Date:08/29/01ISR Number: 3785369-3Report Type:Expedited (15-DaCompany Report #A044-002-003156 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Aricept (Donepezil) PS ORAL SEE IMAGE Hospitalization - Fall Health Zyprexa (Olanzapine) SS ORAL 5 MG, PER Initial or Prolonged Muscular Weakness Professional ORAL Date:08/31/01ISR Number: 3787146-6Report Type:Periodic Company Report #A117222 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Ziprasidone Po PS 20.00 MG Professional TOTAL: DAILY Zyprexa SS Topamax SS 400.00 MG TOTAL: BID Date:08/31/01ISR Number: 3787172-7Report Type:Periodic Company Report #A111235 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Ziprasidone Po PS Psychotic Disorder Professional Zyprexa SS Clozaril SS Date:08/31/01ISR Number: 3787268-XReport Type:Periodic Company Report #A114099 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Ziprasidone Po PS Pfizer 40.00 MG Dizziness Professional TOTAL:BID Insomnia Zyprexa SS Thinking Abnormal Lopressor C Haldol C Pamelor C Ginkgo Biloba C Adderall C Concerta C Date:08/31/01ISR Number: 3787279-4Report Type:Periodic Company Report #A113770 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Ziprasidone Po PS Professional Zyprexa SS 24-Jun-2005 12:19 PM Page: 1491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787531-2Report Type:Periodic Company Report #A113562 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myalgia Health Ziprasidone Po PS ORAL BID:ORAL Professional Zyprexa SS Wellbutrin C Stelazine C Ativan C Date:08/31/01ISR Number: 3787598-1Report Type:Periodic Company Report #A112562 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myalgia Consumer Ziprasidone PS ORAL 120.00 MG Pharyngitis Health TOTAL:BID:ORA Professional L Zyprexa SS ORAL 5.00 MG TOTAL:DAILY:O RAL Docusate C Famotidine C Lorazepam C Fluvoxamine C Date:08/31/01ISR Number: 3787644-5Report Type:Periodic Company Report #A111596 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Ziprasidone Po PS ORAL 80.00 MG Chills Professional TOTAL:BID:ORA Dizziness L Hyperhidrosis Zyprexa SS 20.00 MG Sedation TOTAL Date:08/31/01ISR Number: 3787686-XReport Type:Periodic Company Report #A111593 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Ziprasidone Po PS ORAL 100.00 MG Attention Professional TOTAL:BID:ORA Deficit/Hyperactivity L Disorder Zyprexa SS Dizziness Insomnia Paranoia Schizophreniform Disorder Sedation Date:08/31/01ISR Number: 3788810-5Report Type:Periodic Company Report #A107311 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Ziprasidone Po PS ORAL 40.00 MG Dizziness Health TOTAL:BID:ORA Increased Appetite Professional L Palpitations Olanzapine SS ORAL 10.00 MG TOTAL:DAILY:O 24-Jun-2005 12:19 PM Page: 1492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report RAL Haloperidol C Vitamin C C Unspecified Pain Reliever C Date:08/31/01ISR Number: 3790655-7Report Type:Periodic Company Report #A113160 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Ziprasidone Po PS ORAL 160.00 MG Professional TOTAL:BID:ORA L Zyprexa SS Lithium C Depakote C Date:09/01/01ISR Number: 3789876-9Report Type:Expedited (15-DaCompany Report #GBS010809299 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY Increased Health Procyclidine C Blood Alkaline Professional Lactulose C Phosphatase Increased Other Tibolone C Blood Bilirubin Increased Lorazepam C Hepatic Function Abnormal Date:09/06/01ISR Number: 3788188-7Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Olanzapine PS ORAL 20MG PO 4 WK Irritability Paranoia Date:09/06/01ISR Number: 3788192-9Report Type:Direct Company Report # Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Olanzapine PS 2.5MG TID Abnormal Loxapine C Vitamin E C Dss Zoloft C Senna C Ibuprofen C Date:09/06/01ISR Number: 3788769-0Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nocturia Olanzapine PS ORAL 10 MG QHS PO 6 MON Urinary Incontinence Ranitidine C Maalox C Benadryl C Tylenol C 24-Jun-2005 12:19 PM Page: 1493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/01ISR Number: 3789336-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine Zenith Initial or Prolonged Goldline PS Zenith Goldline ORAL 100 MG/TID/ORAL Zyprexa Eli Lilly SS Eli Lilly ORAL 20MG HS ORAL Date:09/07/01ISR Number: 3789522-4Report Type:Expedited (15-DaCompany Report #US_010769249 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa (Olanzapine) PS 30 MG/DAY 25 DAY Increased Professional Trileptal Aspartate Company (Oxcarbazepine) C Aminotransferase Representative Celexa(Citalopram Increased Hydrobromide) C Blood Sodium Decreased Oedema Peripheral Platelet Count Decreased White Blood Cell Count Decreased Date:09/07/01ISR Number: 3789729-6Report Type:Expedited (15-DaCompany Report #AU_010603721 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Decreased Foreign Olanzapine PS 10 MG/DAY Hospitalization - Bradycardia Health Voersyl (Perinopril) C Initial or Prolonged Confusional State Professional Convulsion Other Coordination Abnormal Dizziness Drug Toxicity Emphysema Polydipsia Date:09/07/01ISR Number: 3789731-4Report Type:Expedited (15-DaCompany Report #DE_010806483 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Olanzapine PS Initial or Prolonged Bladder Disorder Literature Digoxin C Other Bradycardia Health Sotalol C Dysphagia Professional Acetylsalcyclic Acid C Extrapyramidal Disorder Other Captopril C Malnutrition Risperidone C Urinary Retention Promethazine C Date:09/07/01ISR Number: 3789795-8Report Type:Expedited (15-DaCompany Report #DE_980500047 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Leukopenia Foreign Psychotic Disorder Literature Health Professional 24-Jun-2005 12:19 PM Page: 1494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 1 5 MG/DAY Parkotil (Pergolide Mesylate) SS Madopar C Nacom C Donepezil Hydrochloride C Date:09/07/01ISR Number: 3789798-3Report Type:Expedited (15-DaCompany Report #DE_010806602 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Foreign Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Health Professional Other Date:09/07/01ISR Number: 3789800-9Report Type:Expedited (15-DaCompany Report #AU_010804042 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Emotional Distress Foreign Olanzapine PS White Blood Cell Count Study Increased Health Professional Other Date:09/07/01ISR Number: 3789817-4Report Type:Expedited (15-DaCompany Report #US-010872266 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coombs Positive Health Zyprexa (Olanzapine) PS 5 MG/DAY 2 MON Haemolytic Anaemia Professional Effexor (Venlafaxine Pancytopenia Hydrochloride) C Date:09/07/01ISR Number: 3789872-1Report Type:Expedited (15-DaCompany Report #US_010769430 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Dysarthria Health Serenace Increased Appetite Professional (Haloperidol) C Insomnia Company Akineton (Biperiden Pruritus Representative Hydrochloride) C Speech Disorder Other Developmental Tongue Paralysis Weight Increased 24-Jun-2005 12:19 PM Page: 1495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/01ISR Number: 3789877-0Report Type:Expedited (15-DaCompany Report #EWC010325860 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Hyponatraemia Health Akineton (Biperiden Initial or Prolonged Lower Respiratory Tract Professional Hydrochloride) C Infection Other Stilnox (Zolpidem) C Lung Disorder Oral Candidiasis Ulcer Date:09/07/01ISR Number: 3789878-2Report Type:Expedited (15-DaCompany Report #US_010871419 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Life-Threatening Cardiac Arrest Health Seroquel C Other Depressed Level Of Professional Contomin Consciousness Company (Chlorpromazine Dyspnoea Representative Hydjrochloride) C Other Serenace (Haloperidol) C Date:09/07/01ISR Number: 3789879-4Report Type:Expedited (15-DaCompany Report #US_010871266 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Life-Threatening Phosphokinase Increased Health Contomin Dysphasia Professional (Chlorpromazine Hyperhidrosis Company Hydrochloride) C Neuroleptic Malignant Representative Vegetamin A C Syndrome Other Benzalin Pneumonia (Nitrazepam) C Salivary Hypersecretion Brotizolam C Stupor Cabaser (Cabergoline) C Haloperidol C Trihexyphenidyl C Rohypnol (Flunitrazepam) C Hirnamin (Levomepromazine) C Cremin (Mosapramine Hydrochloride) C Hiberna(Promethazine Hydrochloride) C Date:09/07/01ISR Number: 3789880-0Report Type:Expedited (15-DaCompany Report #US_010870695 Age:60 YR Gender:Male I/FU:F Outcome PT Other Cerebral Infarction Dysphagia Electroencephalogram Abnormal Extrapyramidal Disorder Muscle Rigidity 24-Jun-2005 12:19 PM Page: 1496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stupor Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Professional Company Representative Other Date:09/07/01ISR Number: 3789887-3Report Type:Expedited (15-DaCompany Report #US_010769393 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa (Olanzapine) PS Eli Lilly And Co 10 MG/DAY Initial or Prolonged Face Oedema Health Selbex (Teprenone) C Hypoproteinaemia Professional Isomytal Insomnia Company (Amobarbital) C Neutrophilia Representative Furosemide C Oedema Peripheral Other Gaslon (Irsogladine Pica Maleate) C Rash Erythematous Pariet (Rabeprazole Rash Generalised Sodium) C Restlessness White Blood Cell Count Increased Date:09/07/01ISR Number: 3789888-5Report Type:Expedited (15-DaCompany Report #DE_001003278 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa (Olanzapine) PS 20 MG/1 DAY Health Benzodiazepine C Professional Other Date:09/07/01ISR Number: 3789890-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU08675 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Muscle Rigidity Foreign Exelon Hospitalization - Neuroleptic Malignant Health (Rivastigmine) PS Initial or Prolonged Syndrome Professional Zyprexa (Olanzapine) SS 2.5 MG/D, Pyrexia Other Prednisolone C Date:09/07/01ISR Number: 3790114-1Report Type:Expedited (15-DaCompany Report #US_010871911 Age:36 YR Gender:Female I/FU:I Outcome PT Death Blood Creatine Life-Threatening Phosphokinase Increased Other Depressed Level Of Consciousness Hepatic Failure Neuroleptic Malignant Syndrome Renal Failure 24-Jun-2005 12:19 PM Page: 1497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Failure Sedation Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 30 MG/DAY Professional Clonazepam C Company Zoloft (Sertraline Representative Hydrochloride) C Synthroid (Levothyroxine Sodium) C Chronulac (Lactulose) C Colace (Docusate Sodium) C Simethicone C Date:09/07/01ISR Number: 3790117-7Report Type:Expedited (15-DaCompany Report #US_010871760 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatitis Health Zyprexa (Olanzapine) PS 30 MG/1 DAY 1 MON Hospitalization - Multi-Organ Failure Professional Tegretol Initial or Prolonged Pyrexia (Caramazepine) C Schizoaffective Disorder C Date:09/07/01ISR Number: 3790119-0Report Type:Expedited (15-DaCompany Report #US_010871238 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Health Zyprexa (Olanzapine) PS 15 MG/1 DAY 8 MON Initial or Prolonged Ileus Paralytic Professional Depakote (Valproate Sepsis Semisodium) C Date:09/07/01ISR Number: 3790121-9Report Type:Expedited (15-DaCompany Report #US_010872350 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Consumer Zyprexa (Olanzapine) PS 15 MG/ AT Increased BEDTIME 2 YR Prozac (Fluoxetine Hydrochloride) SS 2 YR Topamax (Topiramate) C Wellbutrin Sr (Amfebutamone Hydrochloride) C Klonopin (Clonazepam) C Date:09/07/01ISR Number: 3790156-6Report Type:Expedited (15-DaCompany Report #US_010872262 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonitis Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional Company Representative 24-Jun-2005 12:19 PM Page: 1498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/01ISR Number: 3790158-XReport Type:Expedited (15-DaCompany Report #US_010872216 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Consumer Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Psychotic Disorder Date:09/07/01ISR Number: 3790159-1Report Type:Expedited (15-DaCompany Report #US_010872137 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Zyprexa (Olanzapine) PS 2.5 MG/DAY 2 YR Oedema Professional Miralax C Multivitamin C Antacid Liquid Plus Simethicone C Pepcid (Famotidine) C Wellbutrin (Amfebutamone Hydrochloride) C Date:09/07/01ISR Number: 3790160-8Report Type:Expedited (15-DaCompany Report #US_010872130 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Consumer Zyprexa (Olanzapine) PS 2 YR Initial or Prolonged Mania Other Weight Increased Date:09/07/01ISR Number: 3790173-6Report Type:Expedited (15-DaCompany Report #US_010871944 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Literature Olanzapine PS 10 MG/DAY Hepatitis C Health Leukopenia Professional Platelet Count Decreased Psychotic Disorder Date:09/07/01ISR Number: 3790279-1Report Type:Expedited (15-DaCompany Report #US_010872376 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Health Gramalil (Tiapride Professional Hydrochloride) C Company Serenace Representative (Haloperidol) C Akineton (Biperiden Hydrochloride) C Ubretid (Distigmine Bromide) C 24-Jun-2005 12:19 PM Page: 1499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/01ISR Number: 3790282-1Report Type:Expedited (15-DaCompany Report #DE_010806562 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 560 MG/DAY Overdose Health Remergil Professional (Mirtazapine) C Other Date:09/07/01ISR Number: 3790283-3Report Type:Expedited (15-DaCompany Report #GBS010809350 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Zyprexa (Olanzapine) PS Exposure To Therapeutic Health Oxazepam C Drugs Professional Zopiclone C Neonatal Disorder Other Polycythaemia Date:09/08/01ISR Number: 3789813-7Report Type:Expedited (15-DaCompany Report #US_010872602 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspiration Health Zyprexa (Olanzapine) PS UNKNOWN Professional Company Representative Date:09/11/01ISR Number: 3791434-7Report Type:Expedited (15-DaCompany Report #A117982 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Effect Decreased Health Ziprasidone Po PS ORAL 160.00 MG Intervention to Dyspnoea Professional TOTAL:BID:ORA Prevent Permanent Oedema L Impairment/Damage Psychotic Disorder Zyprexa (Olanzapine) SS Pulmonary Oedema Celexa (Citalopram) C Respiratory Distress Xanax (Alprazolam) C Suicidal Ideation Date:09/12/01ISR Number: 3790924-0Report Type:Direct Company Report # Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Epistaxis Zyprexa 2 1/2 Mg PS ORAL 1.25 MG / Intervention to ORAL Prevent Permanent Impairment/Damage Date:09/12/01ISR Number: 3791673-5Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Zyprexa (7.5 Mg) Initial or Prolonged (Lilly) PS Lilly ORAL 15 MG HS PO 6 MON 24-Jun-2005 12:19 PM Page: 1500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/01ISR Number: 3791734-0Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olazapine (Zyprexa) Hospitalization - Syndrome 10 Mg Po Qhs PS ORAL 10 MG PO QHS Initial or Prolonged PRIOR TO ADMISSION Amitriptyline C Venafaxine C Amlodipine C Topiramate C Date:09/12/01ISR Number: 3792251-4Report Type:Expedited (15-DaCompany Report #US_010565042 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Pr Health Zyprexa (Olanzapine) PS 10 MG/1 AT Shortened Professional BEDTIME 5 WK Electrocardiogram St Loxitane (Loxapine Segment Abnormal Succinate) C Ventricular Arrhythmia Multivitamins C Date:09/12/01ISR Number: 3792462-8Report Type:Expedited (15-DaCompany Report #GBS010809222 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa (Olazapine) PS 15 MG/1 DAY Pulmonary Oedema Health Paroxetine C Sudden Death Professional Zopiclone C Company Procyclidine C Representative Other Date:09/12/01ISR Number: 3792463-XReport Type:Expedited (15-DaCompany Report #GBS010809350 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Complications Of Maternal Foreign Zyprexa (Olazapine) PS Other Exposure To Therapeutic Health Oxazepam C Drugs Professional Zopiclone C Polycythaemia Other Date:09/12/01ISR Number: 3792464-1Report Type:Expedited (15-DaCompany Report #GBS010809244 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa (Olazapine) PS Coronary Artery Disease Health Lustral (Sertraline Inflammation Professional Hydrochloride) C Lung Consolidation Company Overdose Representative Pulmonary Congestion Other Pulmonary Oedema Toxicologic Test Abnormal 24-Jun-2005 12:19 PM Page: 1501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/01ISR Number: 3792465-3Report Type:Expedited (15-DaCompany Report #EWC990904129 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Zyprexa (Olanzapine) PS Hospitalization - Toxic Epidermal Health Azantac (Ranitidine Initial or Prolonged Necrolysis Professional Hydrochloride) C Other Other Tegretol (Carbamazepine) C Tercian (Cyamemazine) C Stilnox (Zolpidem) C Date:09/12/01ISR Number: 3792466-5Report Type:Expedited (15-DaCompany Report #EWC010627373 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carbon Monoxide Poisoning Foreign Olanzapine PS 40 MG/DAY Completed Suicide Health Professional Company Representative Other Date:09/12/01ISR Number: 3792467-7Report Type:Expedited (15-DaCompany Report #EWC010225705 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acne Foreign Zyprexa (Olanzapine) PS 500 MG DAY Hospitalization - Convulsion Health Initial or Prolonged Depressed Level Of Professional Consciousness Company Intentional Misuse Representative Loss Of Consciousness Other Sedation Speech Disorder Suicide Attempt Tachycardia Weight Increased Date:09/12/01ISR Number: 3792468-9Report Type:Expedited (15-DaCompany Report #CA_010503671 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Aminotransferase Health Increased Professional Blood Alkaline Company Phosphatase Increased Representative Dehydration Other Diabetes Mellitus Diabetic Hyperosmolar Coma Gamma-Glutamyltransferase Increased Malaise Medication Error Pulmonary Congestion 24-Jun-2005 12:19 PM Page: 1502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/01ISR Number: 3792470-7Report Type:Expedited (15-DaCompany Report #DE_000302197 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 1 MON Health Seroxat (Paroxetine Professional Hydrochloride) C Other Tavor (Lorazepam) C Date:09/12/01ISR Number: 3792472-0Report Type:Expedited (15-DaCompany Report #US_010872376 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Anaemia Health Gramalil (Tiapride Bronchospasm Professional Hydrochloride) C Faecal Incontinence Company (Haloperidol) C Fall Representative Akineton (Biperiden Injury Other Hydrochloride) C Sepsis Ubretid (Distigmine Bromide) C Artane (Trihexyphenidyl Hydrochloride) C Amoban (Zopiclone) C Date:09/12/01ISR Number: 3792474-4Report Type:Expedited (15-DaCompany Report #US_010871705 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Other Diabetes Mellitus Health Diabinese Diabetic Coma Professional (Chlorpropamide) C Hyperglycaemia Other Date:09/12/01ISR Number: 3792480-XReport Type:Expedited (15-DaCompany Report #US_010871419 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Life-Threatening Blood Pressure Increased Health Seroquel C Other Brain Damage Professional Contomin Cardiac Arrest Company (Chlorpromazine Coma Representative Hydrochloride) C Neuroleptic Malignant Other Serenace Syndrome (Haloperidol) C Oliguria Oxygen Saturation Decreased Respiratory Arrest Vomiting Date:09/12/01ISR Number: 3792493-8Report Type:Expedited (15-DaCompany Report #PHBS2001CH08916 Age:44 YR Gender:Male I/FU:I Outcome PT Death Agitation Bronchitis 24-Jun-2005 12:19 PM Page: 1503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) Health Unknown PS Professional Entumin (Clotiapine) Other Unknown SS Lorazepam (Lorazepam) SS Promazine (Promazine) SS Midazolam (Midazolam) SS Olanzapine (Olanzapine) SS Seretide (Salmeterol, Fluticasone Propionate) C Serevent (Salmeterol Xinafoate) C Amoxicillin (Amoxicillin) C Clavulanic Acid (Clavulanic Acid) C Clarithromycin (Clarithromycin) C Prednisolone C Tienam (Imipenem, Cilastatin) C Morphine (Morhpine) C Haloperidol C Date:09/12/01ISR Number: 3792690-1Report Type:Expedited (15-DaCompany Report #GBR004398 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Foreign Verapamil PS ORAL 2400 MG PO Anuria Literature Olanzapine SS 5 MG DAILY Blood Culture Positive Health Ketorolac C Bradycardia Professional Morphine Sulfate C Cerebral Infarction Other Temazepam C Coma Dysphagia Hypertension Hypotension Infection Overdose Pancreatitis Haemorrhagic Pathogen Resistance Peritonitis Pneumonia Procedural Site Reaction Wound Secretion 24-Jun-2005 12:19 PM Page: 1504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/01ISR Number: 3792715-3Report Type:Expedited (15-DaCompany Report #DE_010806601 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Foreign Zyprexa PS 15 MG/DAY Initial or Prolonged Consumer Health Professional Other Date:09/12/01ISR Number: 3792717-7Report Type:Expedited (15-DaCompany Report #US_010973015 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Oedema Foreign Zyprexa (Olanzapine) PS Skin Disorder Health Stevens-Johnson Syndrome Professional Company Representative Other Date:09/12/01ISR Number: 3792719-0Report Type:Expedited (15-DaCompany Report #DE_010806644 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Uric Acid Increased Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Fungal Skin Infection Health Sepram (Citalopram Rhabdomyolysis Professional Hydrobromide) C Other Testosteron (Testosterone Propionate) C Date:09/12/01ISR Number: 3792722-0Report Type:Expedited (15-DaCompany Report #US_010872580 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyponatraemia Foreign Zyprexa PS 2.5 MG/DAY Hospitalization - Pancytopenia Health Hicaliq C Initial or Prolonged Pyrexia Professional Tagamet (Cimetidine) C Sepsis Company Primperan Vomiting Representative (Metoclopramide) C Other Intralipos (Soya Oil) C Ferric Hydroxide Colloidal C Proteamin 12x C Serenace (Haloperidol) C Date:09/12/01ISR Number: 3792725-6Report Type:Expedited (15-DaCompany Report #US_010872415 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Other C-Reactive Protein Foreign Increased Health Headache Professional Pancytopenia Company Pyrexia Representative 24-Jun-2005 12:19 PM Page: 1505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG/DAY Serenace (Haloperidol) C Contomin (Chlorpromazine Hydrochloride) C Rohypnol (Flunitrazepam) C Levotomin (Levomepromazine Maleate) C Benzalin (Mitrazepam) C Date:09/12/01ISR Number: 3792726-8Report Type:Expedited (15-DaCompany Report #EWC010827872 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Zyprexa (Olanzapine) PS 35 MG/DAY Overdose Health Litarex (Lithium White Blood Cell Count Professional Citrate) C Decreased Other Risperdal (Risperidone) C Domnamid (Estazolam) C Trilafon (Perphenazine) C Date:09/12/01ISR Number: 3793023-7Report Type:Expedited (15-DaCompany Report #US_010872464 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulomatous Liver Health Zyprexa (Olanzapine) PS 6 MON Disease Professional Date:09/12/01ISR Number: 3793025-0Report Type:Expedited (15-DaCompany Report #US_010973031 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa Zydis Professional (Olanzapine) PS 20 MG/DAY Company Representative Date:09/17/01ISR Number: 3793934-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Life-Threatening Body Temperature Increased Confusional State Depressed Level Of Consciousness Dyspnoea Heart Rate Increased 24-Jun-2005 12:19 PM Page: 1506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxygen Saturation Decreased Report Source Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL QHS PO Allopurinol C Ecotrin C Exelon C Flomax C Furosemide C Neurontin C Plavix C Proscar C Tylenol C Roxicet C Mom C Date:09/17/01ISR Number: 3794042-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Zyprexa 10 Mg Lilly PS Lilly ORAL 10 MG HS ORAL Carbamazepine C Ferrous Sulfate C Gabapentin C Mirtazapine C Magnesium Citrate C Ranitidine C Date:09/17/01ISR Number: 3794417-6Report Type:Expedited (15-DaCompany Report #US_010565042 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Pr Health Zyprexa (Olanzapine) PS 10 MG/1 AT Shortened Professional BEDTIME 5 WK Electrocardiogram St Loxitane (Loxapine Segment Abnormal Succinate) C Multivitamins C Date:09/17/01ISR Number: 3794426-7Report Type:Expedited (15-DaCompany Report #US_010871462 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa (Olanzapine) PS 5 MG/DAY Hospitalization - Hepatic Failure Professional Initial or Prolonged Leukocytosis Company Other Metabolic Acidosis Representative Neuroleptic Malignant Syndrome Pneumonia Staphylococcal Renal Failure Respiratory Acidosis Respiratory Failure Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 1507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/01ISR Number: 3794468-1Report Type:Expedited (15-DaCompany Report #US_010769430 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Emotional Disorder Health Serenace Euphoric Mood Professional (Haloperidol) C Feeling Abnormal Company Akineton (Biperiden Increased Appetite Representative Hydrochloride) C Paraesthesia Other Pruritus Speech Disorder Tongue Paralysis Weight Increased Date:09/17/01ISR Number: 3794644-8Report Type:Expedited (15-DaCompany Report #US_990421242 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa (Olanzapine) PS 25 MG/1 DAY Back Pain Health Antihypertensive C Joint Stiffness Professional Baycol (Cerivastatin Muscle Spasms Sodium) C Nephrolithiasis Pravachol Nightmare (Pravastatin Sodium) C Pain In Extremity Indapamide C Pruritus Genital Date:09/17/01ISR Number: 3794778-8Report Type:Expedited (15-DaCompany Report #DE_010806644 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Health Sepram (Citalopram Professional Hydrobromide) C Other Testosteron (Testosterone Propionate) C Date:09/17/01ISR Number: 3794781-8Report Type:Expedited (15-DaCompany Report #US_010768781 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Increased Health Vegetamin B C Aspartate Professional Flunitrazepam C Aminotransferase Company Nitrazepam C Increased Representative Sennoside C Blood Alkaline Polycarbophil Phosphatase Increased Calcium C Blood Bilirubin Increased Jaundice 24-Jun-2005 12:19 PM Page: 1508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/01ISR Number: 3794978-7Report Type:Expedited (15-DaCompany Report #GBS010809244 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa (Olanzapine) PS Drug Toxicity Health Lustral (Sertraline Intentional Self-Injury Professional Hydrochloride) C Lung Consolidation Company Overdose Representative Pulmonary Congestion Other Pulmonary Oedema Date:09/17/01ISR Number: 3794982-9Report Type:Expedited (15-DaCompany Report #EWC010727622 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Neutropenia Health Loxapac (Loxapine Professional Succinate) C Other .. C Date:09/17/01ISR Number: 3795717-6Report Type:Expedited (15-DaCompany Report #DE_010505759 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Health Professional Other Date:09/17/01ISR Number: 3795735-8Report Type:Expedited (15-DaCompany Report #US_010871266 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Life-Threatening Metabolic Acidosis Health Contomin Neuroleptic Malignant Professional (Chlorpromazine Syndrome Company Hydrochloride) C Pneumonia Representative Vegetamin A C Stupor Other Benzalin (Nitrazepam) C Brotizolam C Cabaser (Cabergoline) C Haloperidol C Trihexyphenidyl C Rohypnol (Flunitrazepam) C Hirnamin (Levomepromazine) C Cremin (Mosapramine Hydrochloride) C Hiberna (Promethazone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/01ISR Number: 3795737-1Report Type:Expedited (15-DaCompany Report #US_010872580 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyponatraemia Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Hospitalization - Malnutrition Health Hicaliq C Initial or Prolonged Pancytopenia Professional Tagamet (Cimetidine) C Sepsis Company Primperan Vomiting Representative (Metoclopramide) C Other Intralipos (Soya Oil) C Ferric Hydroxide Colloidal C Proteamin C Serenace (Haloperidol) C Date:09/18/01ISR Number: 3795284-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005240 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Haldol (Unspecified) Liver Function Test Health (Haloperidol) PS ORAL 10 MG DAILY, Abnormal Professional ORAL Metabolic Acidosis Eritumine Pyrexia (Clotiapine) SS ORAL SEE IMAGE Respiratory Failure Leponex (Clozapine) SS STANDARD DAILY DOSE (PRIOR TO HOSPITALISATI ON ): 400 MG/ Temesta (Lorazepam) SS INTRAVENOUS SEE IMAGE Promazine (Promazine) SS 150 MG Midazolam (Midazolam) SS 9 MG Olanzapine (Olanzapine) SS 5 MG Fraxiparine (Heparin Fraction, Calcium Salt) C Morphine (Morphine) C Seretide (Salmeterol Xinafoate) C Date:09/20/01ISR Number: 3796324-1Report Type:Expedited (15-DaCompany Report #A120462 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zoloft Tablets PS ORAL 100.00 MG Initial or Prolonged Exposure To Therapeutic Other TOTAL:ORAL Drugs Zyprexa SS ORAL ORAL Extrapyramidal Disorder 24-Jun-2005 12:19 PM Page: 1510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/01ISR Number: 3796491-XReport Type:Direct Company Report #USP 54390 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa Zydis (Olanzapine) PS Lilly Apomorphine SS Demtecth/Scherer Dds Date:09/21/01ISR Number: 3797597-1Report Type:Expedited (15-DaCompany Report #A121393 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zoloft Tablets PS ORAL ORAL Laryngotracheo Bronchitis Health Olanzapine SS ORAL ORAL Overdose Professional Pulmonary Congestion Date:09/25/01ISR Number: 3798499-7Report Type:Expedited (15-DaCompany Report #US_010872376 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa ( Initial or Prolonged Anaemia Health Olanzapine) PS Bronchospasm Professional Gramalil (Tiapride Faecal Incontinence Company Hydrochloride) C Fall Representative Serenace Heart Rate Increased Other (Haloperidol) C Injury Akineton (Biperiden Sepsis Hydrochloride) C Ubretid (Distigmine Bromide) C Artane (Trihexyphenidyl Hydrochloride) C Amoban (Zopiclone) C Date:09/25/01ISR Number: 3798971-XReport Type:Expedited (15-DaCompany Report #US_010973086 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Hyponatraemia Health Tegretol Purpura Professional (Carbamazepine) C Company Selenica-R Representative (Valproate Sodium) C Akineton (Biperiden Hydrochloride) C Marzulene S C Magnesium Oxide C Date:09/25/01ISR Number: 3799122-8Report Type:Expedited (15-DaCompany Report #US_010872415 Age:58 YR Gender:Female I/FU:F Outcome PT Other C-Reactive Protein Increased Headache Pyrexia 24-Jun-2005 12:19 PM Page: 1511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Count Decreased White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Serenace Professional (Haloperidol) C Company Contomin Representative (Chlorpromazine Other Hydrochloride) C Rohypnol (Flunitrazepam) C Levotomin (Levomepromazine Maleate) C Benzalin (Nitrazepam) C Date:09/25/01ISR Number: 3799998-4Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:09/25/01ISR Number: 3800111-5Report Type:Direct Company Report # Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Zyprexa Misc. PS 1 A DAY Dry Mouth Dyskinesia Ill-Defined Disorder Mood Swings Date:09/25/01ISR Number: 3800758-6Report Type:Expedited (15-DaCompany Report #US_010973442 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Zyprexa (Olanzapine) PS 15 MG/DAY 1 YR Dizziness Professional Parnate Fear (Tranycypromine Hypotension Sulfate) C Joint Stiffness Klonopin Nervousness (Clonazepam) C Paralysis Topamax (Topiramate) C Photopsia Depakote (Valproate Sedation Semisodium) C Speech Disorder Tremor Visual Disturbance 24-Jun-2005 12:19 PM Page: 1512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3800759-8Report Type:Expedited (15-DaCompany Report #US_010973640 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa (Olanzapine) PS 15 MG/DAY Professional Haldol (Haloperidol) C Company Representative Date:09/25/01ISR Number: 3800760-4Report Type:Expedited (15-DaCompany Report #US_010973286 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cachexia Health Zyprexa (Olanzapine) PS Oral Intake Reduced Professional Lorazepam C Company Representative Date:09/25/01ISR Number: 3800787-2Report Type:Expedited (15-DaCompany Report #A121393 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Zoloft Tablets PS ORAL ORAL Coronary Artery Disease Health Zyprexa (Olanzapine) SS ORAL ORAL Inflammation Professional Caffeine C Intentional Misuse Other Nicotine C Pulmonary Congestion Respiratory Disorder Date:09/25/01ISR Number: 3800803-8Report Type:Expedited (15-DaCompany Report #EWC010928188 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine PS 10 MG/DAY Health Tranxilium(Clorazepa Professional te Dipotassium) C Other Oxybutynin C Date:09/25/01ISR Number: 3800805-1Report Type:Expedited (15-DaCompany Report #US_010973086 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa PS Eli Lilly And Initial or Prolonged Condition Aggravated Health Company 20 MG/DAY Platelet Count Decreased Professional Tegretol Purpura Company (Carbamazepine) C Representative Selenica-R(Valproate Other Sodium) C Akineton(Biperiden Hydrochloride) C Marzulene S C Magnesium Oxide C 24-Jun-2005 12:19 PM Page: 1513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3800806-3Report Type:Expedited (15-DaCompany Report #EWC010928195 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS Eli Lilly And Initial or Prolonged Phosphokinase Increased Health Company 15 MG/DAY Blood Lactate Professional Lexomil (Bromazepam) C Dehydrogenase Increased Other Temesta (Lorazepam) C Hypokalaemia Tercian(Cyamemazine) C Polyuria Parkinnane (Trihexyphenidyl Hydrochloride) C Date:09/25/01ISR Number: 3800807-5Report Type:Expedited (15-DaCompany Report #EWC010928145 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Foreign Olanzapine PS Eli Lilly And Hospitalization - Increased Health Company 10 MG/1 DAY Initial or Prolonged Leukopenia Professional Oxazepam C Neutropenia Other Seroxat (Paroxetine Skin Disorder Hydrochloride) C Thrombocytopenia Date:09/25/01ISR Number: 3800808-7Report Type:Expedited (15-DaCompany Report #EWC010928163 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Olanzapine PS Eli Lilly And Depression Health Company 10 MG/DAY Dizziness Professional Trittico (Trazodone Other Hydrochloride) C Date:09/25/01ISR Number: 3800809-9Report Type:Expedited (15-DaCompany Report #EWC010928162 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine PS Eli Lilly And Injury Health Company 5 MG/DAY Professional Mirtazapine C Other Alprazolam C Date:09/25/01ISR Number: 3800810-5Report Type:Expedited (15-DaCompany Report #EWC010928155 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Foreign Olanzapine PS Eli Lilly And Epistaxis Health Company 10 MG/DAY Professional Dextroamphetamine Other Sulfate C Date:09/25/01ISR Number: 3800811-7Report Type:Expedited (15-DaCompany Report #DE_010906714 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Haematemesis Foreign Melaena Health 24-Jun-2005 12:19 PM Page: 1514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Eli Lilly And Company 7.5 MG/DAY Date:09/25/01ISR Number: 3800812-9Report Type:Expedited (15-DaCompany Report #DE_010906726 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulation Factor V Foreign Zyprexa(Olanzapine) PS Initial or Prolonged Level Increased Health Atosil(Isopromethazi Deep Vein Thrombosis Professional ne Hydrochloride) C Other Date:09/25/01ISR Number: 3800813-0Report Type:Expedited (15-DaCompany Report #CA_010904285 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Iron Decreased Foreign Zyprexa(Olanzapine) PS 10 MG/DAY Initial or Prolonged Hepatitis Health Pimozide C Iron Binding Capacity Professional Amozide C Total Decreased Company Leukocytosis Representative Pain In Extremity Other Pyrexia Red Blood Cell Sedimentation Rate Increased Serum Ferritin Increased Thrombocythaemia White Blood Cell Count Increased Date:09/25/01ISR Number: 3800814-2Report Type:Expedited (15-DaCompany Report #AU_010904116 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Foreign Olanzapine PS 70 MG Initial or Prolonged Overdose Health Fluvoxamine C Viral Myocarditis Professional Other Date:09/25/01ISR Number: 3800815-4Report Type:Expedited (15-DaCompany Report #EWC010928247 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa(Olanzapine) PS 576 DAY Intentional Misuse Health Temesta(Lorazepam) C Toxicologic Test Abnormal Professional Other 24-Jun-2005 12:19 PM Page: 1515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3801073-7Report Type:Expedited (15-DaCompany Report #US_010973227 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Increased Health Sertraline C Neutrophil Count Professional Sibutramine C Decreased Other White Blood Cell Count Decreased Date:09/25/01ISR Number: 3801074-9Report Type:Expedited (15-DaCompany Report #AU_010904098 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Malaise Health Psychotic Disorder Professional Company Representative Other Date:09/25/01ISR Number: 3801082-8Report Type:Expedited (15-DaCompany Report #US_010973015 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Oedema Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Pigmentation Disorder Health Seroquel C Initial or Prolonged Stevens-Johnson Syndrome Professional Miradol (Sulpiride) C Company Impromen Representative (Bromperidol) C Other Lodopin (Zotepine) C Akineton (Biperiden Hydrochloride) C Chlorpromazine C Pantosin (Pantethine) C Selbex (Teprenone) C Levomepromazine C Date:09/25/01ISR Number: 3801211-6Report Type:Expedited (15-DaCompany Report #US_010872580 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Hospitalization - Anxiety Health Hicaliq C Initial or Prolonged Hyponatraemia Professional Tagamet (Cimetidine) C Iron Deficiency Company Primperan Malnutrition Representative (Metoclopramide0 C Pancytopenia Other Intralipos (Soya Pyrexia Oil) C Sepsis Ferric Hydroxide Vomiting Colloidal C Proteamin 12x C Serenace (Haloperidol) C 24-Jun-2005 12:19 PM Page: 1516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3801272-4Report Type:Expedited (15-DaCompany Report #US_010973637 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Health Zyprexa (Olanzapine) PS Professional Paxil (Paroxetine Company Hydrochloride) C Representative Aricept (Donepezil Hydrochloride) C Date:09/25/01ISR Number: 3801275-XReport Type:Expedited (15-DaCompany Report #US_010973641 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa (Olanzapine) PS Professional Amantadine C Date:09/25/01ISR Number: 3801277-3Report Type:Expedited (15-DaCompany Report #US_010973481 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa (Olanzapine) PS 30 MG/1 DAY Professional Company Representative Date:09/25/01ISR Number: 3801285-2Report Type:Expedited (15-DaCompany Report #US_010973572 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Joint Dislocation Health Lexotan (Bromazepam) C Other Loss Of Consciousness Professional Silece Vomiting Other (Flunitrazepam) C Date:09/25/01ISR Number: 3801286-4Report Type:Expedited (15-DaCompany Report #EWC010928296 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS 10 MG Initial or Prolonged Leukocytoclastic Health Vasculitis Professional Urticaria Other Date:09/25/01ISR Number: 3801287-6Report Type:Expedited (15-DaCompany Report #AU_010904115 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Serotonin Syndrome Health Fluoxetine Professional (Fluoxetine Company Hydrochloride) SS 60 MG/DAY Representative Other 24-Jun-2005 12:19 PM Page: 1517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3801311-0Report Type:Expedited (15-DaCompany Report #DE_010906779 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Health Sepram (Citalopram Professional Hydrobromide) C Other Dipiperon (Pipamperone) C Beloc (Metoprolol Tartrate) C Arelix (Piretanide) C Fraxiparin (Heparin-Fraction, Calcium Salt) C Zyloric (Allopurinol) C Date:09/25/01ISR Number: 3801313-4Report Type:Expedited (15-DaCompany Report #EWC010827993 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oxygen Saturation Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Decreased Health Radiotherapy C Pyrexia Professional Lysanxia (Prazepam) C Other Minozinan (Levomepromazine) C Deroxat (Paroxetine Hydrochloride) C Mopral (Omeprazole) C Rivotril (Clonazepam) C Neurontin (Gabapentin) C Solupred (Prednisolone Sodium Sulfobenzoate) C Date:09/25/01ISR Number: 3801401-2Report Type:Expedited (15-DaCompany Report #US_010973034 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Test Abnormal Health Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Neuroleptic Malignant Professional Syndrome Company Representative Date:09/25/01ISR Number: 3801409-7Report Type:Expedited (15-DaCompany Report #US_010973165 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hallucination Consumer Zyprexa (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 1518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3801430-9Report Type:Expedited (15-DaCompany Report #US_010768752 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa(Olanzapine) PS 16 MG/1 DAY Initial or Prolonged Back Pain Lipitor(Atorvastatin Blood Chloride Decreased ) C Blood Sodium Decreased Loxitane(Loxapine Chest Pain Succinate) C Croup Infectious Lithium C Diabetes Mellitus Headache Heart Rate Increased Hypertension Insomnia Laceration Myocardial Infarction Neuroleptic Malignant Syndrome Pco2 Decreased Pleural Disorder Psychiatric Symptom Psychotic Disorder Pyrexia Renal Failure Respiratory Rate Increased Rhabdomyolysis Suicidal Ideation White Blood Cell Count Increased Date:09/25/01ISR Number: 3802320-8Report Type:Expedited (15-DaCompany Report #DE_010806485 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Zyprexa (Olanzapine) PS 5 MG/2 DAY Health Sifrol (Ramipexole Professional Dihydrochloride) C Other Madopar Depot C Potassium C Dopergin (Lisuride Maleate) C Zyloric (Allopurinol) C Bazoton (Urtica Extract) C Sandocal (Calcium Glubionate) C Norvasc (Amlodipine Besilate) C Eunerpan (Melperone Hydrochloride) C Arelix C 24-Jun-2005 12:19 PM Page: 1519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3802321-XReport Type:Expedited (15-DaCompany Report #US_010769393 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Hypoproteinaemia Health Selbex (Teprenone) C Insomnia Professional Isomytal Neutrophilia Company (Amobarbital) C Pica Representative Furosemide C Rash Erythematous Other Gaslon(Irsogladine Restlessness Maleate) C Senile Dementia Pariet (Rabeprazole White Blood Cell Count Sodium) C Increased Date:09/25/01ISR Number: 3802322-1Report Type:Expedited (15-DaCompany Report #DE_010806602 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Foreign Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Health Professional Other Date:09/26/01ISR Number: 3798910-1Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Olanzapine (10 Mg) PS ORAL 20 MG PO QHS Dizziness Quetiapine (100mg) SS ORAL 100 MG PO QHS Fatigue Citalopram C Hunger Quetiapine C Thirst Haldol Decanoate C Weight Increased Date:09/26/01ISR Number: 3799919-4Report Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Olanzapine (7.5mg) PS ORAL 15MG PO QHS Initial or Prolonged Citalopram C Clonazepam C Trazodone C Date:09/27/01ISR Number: 3800045-6Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Olanzapine 7.5mg Tab PS Initial or Prolonged Triamcinolone Acetonide C Venlafaxine C Pergolide Mesylate C Albuterol So4 Inh C Fluocinolone Acetonide C Carbidopa 50/Levodopa C 24-Jun-2005 12:19 PM Page: 1520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loperamide Hcl C Naproxen C Date:09/28/01ISR Number: 3801725-9Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Olanzapine 10mg PS ORAL 20MG BID Abnormal ORALLY Acetaminophen C Capsaicin C Etodolac C Felodipine C Hydroxyzine Pamoate C Methylsalicylate Balm C Quetiapine Fumarate C Ranitidine Hcl C Temazepam C Trazodone Hcl C Date:09/28/01ISR Number: 3801737-5Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Olanzapine 10mg PS 10MG Q HS Abnormal Fluoxetine C Hydroxyzine C Gabapentin C Date:09/28/01ISR Number: 3802056-3Report Type:Direct Company Report # Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Zyprexa (2.5 Mg @Hs Oedema Peripheral Po) PS 2.5 MG Q HS Weight Increased Date:09/28/01ISR Number: 3802751-6Report Type:Periodic Company Report #2000UW05296 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Seroquel "Zeneca" PS "Zeneca" ORAL 125 MG DAILY Vision Blurred Professional PO Zyprexa SS ORAL 20 MG DAILY PO Navane C Date:09/28/01ISR Number: 3802884-4Report Type:Periodic Company Report #2000UW04635 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG BID PO Hypothermia Professional Olanzapine SS Gabapentin SS Reglan SS 24-Jun-2005 12:19 PM Page: 1521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3804678-2Report Type:Periodic Company Report #2000AP04264 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Literature Olanzapine PS 10 MG Intervention to Inadequate Control Health Quetiapine Fumarate SS 100 MG TID Prevent Permanent Professional Sertraline C Impairment/Damage Haloperidol Decanoate C Fluoxetine C Glipizide C Metformin C Venlafaxine C Date:10/01/01ISR Number: 3804162-6Report Type:Expedited (15-DaCompany Report #LBID00201003889 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Lithium, Initial or Prolonged Constipation Health Manufacturer Unknown Diarrhoea Professional (Lithium) PS ORAL 900 MG DAILY Disorientation PO Disturbance In Attention Olanzapine Electroencephalogram (Olanzapine) SS ORAL 5 MG DAILY PO Abnormal Haloperidol Encephalopathy (Haloperidol) SS ORAL 20 MG DAILY Medication Error PO Memory Impairment (Carbamazepine) C Obsessive Thoughts Paranoia Urinary Incontinence Date:10/02/01ISR Number: 3803634-8Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Zyprexa 10mg PS ORAL 10MG QD ORAL Increased Aspartate Aminotransferase Increased Date:10/03/01ISR Number: 3803295-8Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bladder Disorder Zyprexa (10 Mg) PS 10 MG HS 2 MON Body Temperature Geodon (20 Mg) SS 40 MG BID Decreased Lipitor C Coma Communication Disorder Hyperhidrosis Joint Stiffness Muscle Rigidity Paranoia Parkinsonian Gait Tremor 24-Jun-2005 12:19 PM Page: 1522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/01ISR Number: 3804470-9Report Type:Expedited (15-DaCompany Report #US_010973743 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Literature Olanzapine PS 5 MG Initial or Prolonged Suicidal Ideation Health Lamotrigine C Other Professional Valproic Acid C Clonazepam C Bupropion C Date:10/03/01ISR Number: 3804497-7Report Type:Expedited (15-DaCompany Report #US_010973716 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Consumer Zyprexa (Olanzapine) PS 50 MG/DAY Initial or Prolonged Airways Disease Valproic Acid C Exacerbated Paroxetine C Face Oedema Trazodone C Buspirone C Benztropine C Date:10/03/01ISR Number: 3804498-9Report Type:Expedited (15-DaCompany Report #US_010973722 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Consumer Zyprexa (Olanzapine) PS 15 MG/DAY Life-Threatening Foreign Body Aspiration Risperdal Hypoxia (Risperidone) C Ambien (Zolpidem Tartrate) C Date:10/03/01ISR Number: 3804501-6Report Type:Expedited (15-DaCompany Report #US_010973921 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis B Health Zyprexa (Olanzapine) PS 40 MG/DAY Initial or Prolonged Leukopenia Professional Other Lymphoma Company Pyrexia Representative Thrombocytopenia Date:10/03/01ISR Number: 3804503-XReport Type:Expedited (15-DaCompany Report #US_010973910 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Consumer Zyprexa (Olanzapine) PS 7.5 MG/DAY Blood Cholesterol Klonopin Increased (Clonazepam0 C Fatigue Avandia (Rosiglitazone Maleate) C Metformin C Glipizide C Synthroid (Levothyroxine Sodium) C Simvastatin C Colace (Docusate 24-Jun-2005 12:19 PM Page: 1523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Multivitamin C Lantus (Insulin) C Vitamin C Date:10/03/01ISR Number: 3804509-0Report Type:Expedited (15-DaCompany Report #US-010668372 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa (Olanzapine) PS 30 MG/DAY Therapeutic Professional Effexor (Venlafaxine Drug Toxicity Hydrochloride) C Overdose Lamictal Toothache (Lamotrigine) C Date:10/03/01ISR Number: 3804511-9Report Type:Expedited (15-DaCompany Report #US_000235863 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Consumer Zyprexa (Olanzapine) PS 5 MG/DAY Sedation Health Heparin C Professional Company Representative Date:10/03/01ISR Number: 3804527-2Report Type:Expedited (15-DaCompany Report #US_010973861 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Professional Company Representative Date:10/03/01ISR Number: 3805344-XReport Type:Expedited (15-DaCompany Report #US_010872376 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Anaemia Health Gramalil (Tiapride Bronchospasm Professional Hydrochloride C Dehydration Company Serenace Faecal Incontinence Representative (Haloperidol) C Fall Other Akineton (Biperiden Injury Hydrochloride) C Neutrophil Count Ubretid (Distigmine Increased Bromide) C Pyrexia Artane Red Blood Cell Count (Trihexyphenidyl Decreased Hydrochloride) C Sepsis Amoban (Zopiclone) C 24-Jun-2005 12:19 PM Page: 1524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/01ISR Number: 3805346-3Report Type:Expedited (15-DaCompany Report #EWC010928247 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 576 DAY Intentional Misuse Health Temesta (Lorazepam) C Overdose Professional Other Date:10/03/01ISR Number: 3805348-7Report Type:Expedited (15-DaCompany Report #EWC010526873 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Olanzapine PS 10 MG/2 DAY Hospitalization - Dizziness Health Nozinan Initial or Prolonged Hyperglycaemia Professional (Levomepromazine) C Hypotension Other Entumin (Clotiapine) C Loss Of Consciousness Tavor (Lorazepam) C Overdose Date:10/03/01ISR Number: 3805350-5Report Type:Expedited (15-DaCompany Report #EWC010627344 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Weight Increased Health Cipramil (Citalopram Disability Professional Hydrobromide) C Company Representative Other Date:10/03/01ISR Number: 3805352-9Report Type:Expedited (15-DaCompany Report #EWC001108521 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Leukopenia Health Lepticur Urinary Retention Professional (Tropatepine Other Hydrochloride) C Mopral (Omeprazole) C Zoloft (Sertraline Hydrochloride) C Date:10/03/01ISR Number: 3805353-0Report Type:Expedited (15-DaCompany Report #EWC001008359 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Urinary Retention Health Mopral (Omeprazole) C Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 1525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/01ISR Number: 3805355-4Report Type:Expedited (15-DaCompany Report #DE_010706258 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Stangyl Professional (Trimipramine Other Maleate) C Date:10/03/01ISR Number: 3805356-6Report Type:Expedited (15-DaCompany Report #DE_010505818 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Hyperglycaemia Literature Lanitop Upper Respiratory Tract Health (Metildoigoxin) C Infection Professional Syntestan Other (Cloprednol) C Remergil (Mirtazapine) C Pulmicort Turbuhaler (Budesonide) C Berotec Inhaler (Fenoterol) C Calcium C Vigantoletten (Colecalciferol) C Godamed C Ampho Moronal "Bristol-Myers Squibb" (Amphotericin B) C Propycil (Propylthiouracil) C Rulid (Roxithromycin) C Kalinor (Potassium Chloride) C Date:10/03/01ISR Number: 3805729-1Report Type:Expedited (15-DaCompany Report #US_010973015 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Erythema Multiforme Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Oedema Health Seroquel C Initial or Prolonged Professional Miradol (Sulpiride) C Company Impromen Representative (Bromperidol) C Other Lodopin (Zotepine) C Akineton (Biperiden Hydrochloride) C Chlorpromazine C Pantosin (Pantethine) C Selbex (Teprenone) C Levomepromazine C 24-Jun-2005 12:19 PM Page: 1526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/01ISR Number: 3805730-8Report Type:Expedited (15-DaCompany Report #US_010872580 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperphagia Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Hospitalization - Hyponatraemia Health Hicaliq C Initial or Prolonged Pancytopenia Professional Tagamet (Cimetidine) C Pyrexia Company Primperan Sepsis Representative (Metoclopramide) C Vomiting Other Intralipos (Soya Oil) C Ferric Hydroxide Colloidal C Proteamin 12x C Serenace (Haloperidol) C Date:10/03/01ISR Number: 3805733-3Report Type:Expedited (15-DaCompany Report #US_010974040 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Diabetic Coma Health Risperdal Initial or Prolonged Hyperglycaemia Professional (Risperidone) C Other Pharyngitis Company Artane Representative (Trihexyphenidyl Other Hydrochloride) C Rohypnol (Flunitrazepam) C Halcion (Triazolam) C Date:10/03/01ISR Number: 3806061-2Report Type:Expedited (15-DaCompany Report #US_010973926 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombotic Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Thrombocytopenic Purpura Professional Celexa (Citalopram Hydrobromide) C Date:10/03/01ISR Number: 3806110-1Report Type:Expedited (15-DaCompany Report #GBS010909478 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Zyprexa (Olanzapine) PS Coronary Artery Disease Health Lustral (Sertraline Intentional Misuse Professional Hydrochloride) C Pulmonary Congestion Other Tracheitis Date:10/03/01ISR Number: 3806111-3Report Type:Expedited (15-DaCompany Report #EWC010928302 Age:43 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Calcium Decreased Initial or Prolonged Blood Creatine Other Phosphokinase Mb Increased Blood Sodium Decreased 24-Jun-2005 12:19 PM Page: 1527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressed Level Of Consciousness Hypoproteinaemia Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Foreign Olanzapine PS 600 MG/DAY Laboratory Test Abnormal Health Xanax (Alprazolam) C Paraesthesia Professional Renal Impairment Other Rhabdomyolysis Suicide Attempt Date:10/03/01ISR Number: 3806112-5Report Type:Expedited (15-DaCompany Report #EWC010928307 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Hospitalization - Haemoglobin Decreased Health Cisordinol Initial or Prolonged Overdose Professional (Clopenthixol Company Hydrochloride) C Representative Nozinan Other (Levomepromazine) C Date:10/03/01ISR Number: 3806113-7Report Type:Expedited (15-DaCompany Report #EWC010928316 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiogenic Shock Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Coma Health Medication Error Professional Multi-Organ Failure Other Neuroleptic Malignant Syndrome Polyneuropathy Tachycardia Date:10/03/01ISR Number: 3806114-9Report Type:Expedited (15-DaCompany Report #US_010973893 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Constipation Health Haloperidol C Delusion Professional Levomepromazine C Hallucination, Auditory Company Fluphenazine C Insomnia Representative Promethazine Middle Insomnia Other Hydrochloride C White Blood Cell Count Magnesium Oxide C Decreased Sennoside A+B C Date:10/03/01ISR Number: 3806115-0Report Type:Expedited (15-DaCompany Report #US_010973805 Age:36 YR Gender:Female I/FU:I Outcome PT Blood Creatine Phosphokinase Increased Confusional State Hypotension Leukopenia Muscle Rigidity 24-Jun-2005 12:19 PM Page: 1528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Benzodiazepine C Professional Atenolol C Company Representative Other Date:10/03/01ISR Number: 3806116-2Report Type:Expedited (15-DaCompany Report #US_010973487 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Phosphatase Increased Health Serenace Blood Chloride Abnormal Professional (Haloperidol) C Blood Cholesterol Company Artane Increased Representative (Trihexyphenidyl Blood Sodium Abnormal Other Hydrochloride) C Blood Triglycerides Rohypnol Increased (Flunitrazepam) C Cholelithiasis Amoban (Zopiclone) C Gamma-Glutamyltransferase Somelin Increased (Haloxazolam) C Hyperglycaemia Akineton (Biperiden Platelet Count Abnormal Hydrochloride) C White Blood Cell Count Abnormal Date:10/03/01ISR Number: 3806117-4Report Type:Expedited (15-DaCompany Report #EWC010928332 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Zyprexa (Olanzapine) PS 0.5 DSG Initial or Prolonged Weight Increased Health FORM/DAY Professional Solian (Amisulpride) C Other Date:10/03/01ISR Number: 3806122-8Report Type:Expedited (15-DaCompany Report #EWC010928299 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyrexa (Olanzapine) PS 10 MG/DAY Study Depamide Health (Valpromide) C Professional Tranxene Other (Clorazepate Dipotassium) C Ludiomil (Maprotiline Hydrochloride) C Parkinane (Triheyxyphenidyl Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/01ISR Number: 3806124-1Report Type:Expedited (15-DaCompany Report #US_010973842 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Other Pneumonia Aspiration Health Professional Company Representative Other Date:10/03/01ISR Number: 3806125-3Report Type:Expedited (15-DaCompany Report #GBS010809287 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Coagulation Time Health Sulpiride C Prolonged Professional Other Date:10/03/01ISR Number: 3806181-2Report Type:Expedited (15-DaCompany Report #DE_010906845 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Seroxat (Paroxetine Professional Hydrochloride) C Other Tavor (Lorazepam) C Date:10/03/01ISR Number: 3806182-4Report Type:Expedited (15-DaCompany Report #DE_010906844 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Health Professional Other Date:10/03/01ISR Number: 3806802-4Report Type:Expedited (15-DaCompany Report #EWC010928298 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS Health Paroxetine C Professional Trazodone C Other Date:10/05/01ISR Number: 3806079-XReport Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Zyprexa 5mg PS 5MG 1 Q AM 24-Jun-2005 12:19 PM Page: 1530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/01ISR Number: 3807393-4Report Type:Expedited (15-DaCompany Report #2001UW12261 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Foreign Seroquel "Zeneca" PS ORAL 12.5 MG BID Intervention to Laryngospasm Other PO Prevent Permanent Zyprexa SS ORAL 5 MG TID PO 5 DAY Impairment/Damage Sinemet C Date:10/08/01ISR Number: 3806941-8Report Type:Expedited (15-DaCompany Report #1633422A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Sepsis Literature Acetaminophen Hospitalization - Coma Health Product, Unspecified PS ORAL PO Initial or Prolonged Drug Level Above Professional Paxil (See Sect C10) SS ORAL PO Required Therapeutic Zyprexa SS Intervention to Encephalopathy Prevent Permanent Haemodialysis Impairment/Damage Heart Rate Increased Hepatic Failure Renal Failure Date:10/09/01ISR Number: 3805423-7Report Type:Expedited (15-DaCompany Report #A0162626A Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Wellbutrin PS Glaxo Wellcome ORAL Initial or Prolonged Blood Potassium Abnormal Eskalith Cr SS Glaxo Wellcome ORAL 900MG Per day 5 YR Blood Sodium Abnormal Zyprexa SS UNKNOWN Condition Aggravated Prilosec SS UNKNOWN Diplopia Disorientation Electrolyte Imbalance Fall Tremor Date:10/09/01ISR Number: 3805433-XReport Type:Expedited (15-DaCompany Report #B0121882A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Headache Zyban PS Glaxo Wellcome ORAL Therapeutic Agent Olanzapine SS ORAL 20MG per day Toxicity Methadone SS Glaxo Wellcome UNKNOWN Lithium Carbonate C Glaxo Wellcome UNKNOWN Carbimazole C UNKNOWN Date:10/10/01ISR Number: 3808027-5Report Type:Expedited (15-DaCompany Report #FR_010700080 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Pyrexia Health Prozac (Fluoxetine Professional Hydrochloride) SS 40 MG/DAY Company Stilnox (Zolpidem) C Representative Other 24-Jun-2005 12:19 PM Page: 1531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/01ISR Number: 3808029-9Report Type:Expedited (15-DaCompany Report #EWC010928307 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Hospitalization - C-Reactive Protein Health Sisordinol Initial or Prolonged Increased Professional (Clopenthixol Haemoglobin Decreased Company Hydrochloride) C Overdose Representative Nozinan Other (Levomepromazine) C Date:10/10/01ISR Number: 3808034-2Report Type:Expedited (15-DaCompany Report #DE_010806601 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Consumer Health Professional Other Date:10/10/01ISR Number: 3808035-4Report Type:Expedited (15-DaCompany Report #DE_010906714 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematemesis Foreign Zyprexa (Olanzapine) PS 7.5 MG/DAY Melaena Health Professional Other Date:10/10/01ISR Number: 3808036-6Report Type:Expedited (15-DaCompany Report #US_010973842 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Pneumonia Health Professional Company Representative Other Date:10/10/01ISR Number: 3808038-XReport Type:Expedited (15-DaCompany Report #US_010974040 Age:32 YR Gender:Male I/FU:F Outcome PT Death Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Blood Alkaline Other Phosphatase Increased Decreased Appetite Dehydration Depressed Level Of Consciousness Diabetes Mellitus Diabetic Coma Pharyngitis Polydipsia Thirst 24-Jun-2005 12:19 PM Page: 1532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Risperdal Professional (Risperidone) C Company Artane Representative (Trihexyphenidyl Other Hydrochooride) C Rohypnol (Flunitrazepam) C Halcion (Triazolam) C Date:10/10/01ISR Number: 3808061-5Report Type:Expedited (15-DaCompany Report #US_010872376 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Biopsy Bone Marrow Foreign Zyprexa (Olanzapine) PS Hospitalization - Abnormal Health Gramalil (Tiapride Initial or Prolonged Blood Albumin Decreased Professional Hydrochloride) C Bronchospasm Company Serenace Dehydration Representative (Haloperidol) C Faecal Incontinence Other Akineton (Biperiden Fall Hydrochloride) C Injury Ubretid (Distigmine Pancytopenia Bromide) C Protein Total Decreased Artane Pyrexia (Trihexyphenidyl Sepsis Hydrochloride) C Amoban (Zopiclone) C Date:10/10/01ISR Number: 3808325-5Report Type:Expedited (15-DaCompany Report #US_01057105 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa (Olanzapine) PS 15 MG/2 DAY Initial or Prolonged Difficulty In Walking Professional Quetiapine C Dizziness Klonopin Joint Stiffness (Clonazepam) C Physical Assault Tegretol Schizophrenia (Carbamazepine) C Swelling Remeron Tremor (Mirtazapine) C Weight Increased Haldol (Haloperidol) C Ativan (Lorazepam) C Depakote (Valproate Semisodium0 C Date:10/10/01ISR Number: 3808329-2Report Type:Expedited (15-DaCompany Report #US_010770512 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Maculopathy Health Zyprexa (Olanzapine) PS 3 MON Pigmentation Disorder Professional Ortho Cyclen C Methylphenidate C Klonopin (Clonazepam) C Luvox (Fluvoxamine 24-Jun-2005 12:19 PM Page: 1533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) C Date:10/10/01ISR Number: 3809042-8Report Type:Expedited (15-DaCompany Report #US_010974163 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Tenderness Literature Olanzapine PS 2.5 MG/DAY Blood Albumin Decreased Health Sertraline C Blood Pressure Diastolic Professional Lithium C Decreased Cardiac Murmur Electrocardiogram T Wave Inversion Fall Haematuria Heart Rate Increased Influenza Leukocytosis Liver Tenderness Rhabdomyolysis Date:10/10/01ISR Number: 3809044-1Report Type:Expedited (15-DaCompany Report #US_98121465B Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Consumer Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Increased Depakote (Valproate Oedema Peripheral Semisodium) C Lipitor (Atorvastatin) C Estradiol C Lasix (Furosemide) C Remeron (Mirtazapine) C Date:10/10/01ISR Number: 3809150-1Report Type:Expedited (15-DaCompany Report #2001023091-1 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Eskalith PS Smith Beecham ORAL SEE IMAGE 5 YR Initial or Prolonged Condition Aggravated Wellbutrin Diplopia (Bupropion) SS Glaxowellcome Disorientation Zyprexa SS Lilly Electrolyte Imbalance Prilosec Fall (Omeprazole) SS Astrazeneca Tremor Date:10/10/01ISR Number: 3809270-1Report Type:Expedited (15-DaCompany Report #US_010872266 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coombs Positive Health Zyprexa (Olanzapine) PS 5 MG/DAY 2 MON Haemolytic Anaemia Professional Effexor (Venlafaxine Pancytopenia Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/01ISR Number: 3809474-8Report Type:Expedited (15-DaCompany Report #US_010769249 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa (Olanzapine) PS 30 MG/DAY 25 DAY Increased Professional Trileptal Aspartate Company (Oxcarbazepine) C Aminotransferase Representative Celexa (Citalopram Increased Hydrobromide) C Blood Sodium Decreased Oedema Peripheral Platelet Count Decreased White Blood Cell Count Decreased Date:10/10/01ISR Number: 3809492-XReport Type:Expedited (15-DaCompany Report #1998UW47645 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Ineffective Literature Seroquel PS ORAL 200 MG BID PO Intervention to Hepatitis C Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Leukopenia Professional PO Impairment/Damage Platelet Count Decreased Olanzapine SS 10 MG DAILY Psychotic Disorder Risperdal C Date:10/10/01ISR Number: 3809965-XReport Type:Expedited (15-DaCompany Report #EWC010928384 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zyprexa (Olanzapine) PS Initial or Prolonged Urticaria Health Efexor (Venlafaxine Professional Hydrochloride) C Other Ferro-Retard (Ferrous Sulfate) C Vitamineral C Sobril (Oxazepam) C Date:10/10/01ISR Number: 3809966-1Report Type:Expedited (15-DaCompany Report #EWC010928387 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Foreign Olanzapine PS 5 MG/DAY Initial or Prolonged Jaundice Health Flupentixol C Professional Sertraline C Other Levodopa Benserazide Hydrochlo C Biperiden C Date:10/10/01ISR Number: 3809967-3Report Type:Expedited (15-DaCompany Report #US_010974237 Age:63 YR Gender:Female I/FU:I Outcome PT Death Cardiac Failure Cardio-Respiratory Arrest Deep Vein Thrombosis Myocardial Infarction Prostration Pulmonary Thrombosis 24-Jun-2005 12:19 PM Page: 1535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Mevalotin Professional (Pravastatin Sodium) C Company Eurodin (Estazolam) C Representative Other Date:10/10/01ISR Number: 3809971-5Report Type:Expedited (15-DaCompany Report #GBS010909511 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY Epilepsy Health Prozac (Fluoxetine Medication Error Professional Hydrochloride) C Schizophrenia Other Date:10/10/01ISR Number: 3809972-7Report Type:Expedited (15-DaCompany Report #GBS010909482 Age:0 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zyprexa (Olanzapine) PS Exposure To Therapeutic Health Drugs Professional Congenital Hypothyroidism Other Date:10/10/01ISR Number: 3810490-0Report Type:Expedited (15-DaCompany Report #US_010973572 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Hospitalization - Joint Dislocation Health Lexotan (Bromazepan) C Initial or Prolonged Loss Of Consciousness Professional Silece Other Vomiting Other (Flunitrazepam) C Lendormin (Brotizolam) C Pursennid (Senna Leaf) C Date:10/10/01ISR Number: 3810500-0Report Type:Expedited (15-DaCompany Report #US_010872415 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Increased Health Serenace Other Condition Aggravated Professional (Haloperidol) C Headache Company Contomin Mental Disorder Representative (Chlorpromazine Pyrexia Other Hydrochloride) C Red Blood Cell Count Royhpnol Decreased (Flinitrazepam) C White Blood Cell Count Levotomin Decreased (Levomepromazine Maleate) C Benzalin 24-Jun-2005 12:19 PM Page: 1536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nitrazepam) C Date:10/11/01ISR Number: 3807606-9Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:10/11/01ISR Number: 3807653-7Report Type:Direct Company Report # Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Olanzapine PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:10/11/01ISR Number: 3807924-4Report Type:Expedited (15-DaCompany Report #US_010973031 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa Zydis Professional (Olanzapine) PS 20 MG/DAY 2 WK Company Zyprexa (Olanzapine) SS 20 MG/DAY 2 YR Representative Date:10/16/01ISR Number: 3809755-8Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Zyprexa 10mg- Initial or Prolonged Prolonged (Lilly) PS Lilly ORAL 10 MG PO TID 6 DAY Hypertension Lisinopril C Date:10/16/01ISR Number: 3810152-XReport Type:Expedited (15-DaCompany Report #B0121882A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyban Tablet - Zyban Headache (Bupropion Hydrochloride) PS ORAL 150 MG ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Methadone Hydrochloride (Formulation Unknown) (Methadone Hydrochloride) SS 24-Jun-2005 12:19 PM Page: 1537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate C Carbimazole C Date:10/16/01ISR Number: 3810515-2Report Type:Expedited (15-DaCompany Report #A0162626A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Wellbutrin Initial or Prolonged Condition Aggravated Unspecified Tablet Diplopia (Bupropion Disorientation Hydrochloride) PS ORAL ORAL Electrolyte Imbalance Lithium Carbonate Fall (Formulation Tremor Unknown) (Lithium Carbonate) SS ORAL 900 MG / PER DAY / ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS Omeprazole (Formulation Unknown) (Omeprazole) SS Date:10/17/01ISR Number: 3811012-0Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemic Olanzapine 10mg PS ORAL 20MG QD ORAL Hyperosmolar Nonketotic Hydrochlorothiazide C Syndrome Benazepril C Sepsis Date:10/18/01ISR Number: 3811110-1Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Zyprexa 5mg Eli-Lilly PS Eli-Lilly ORAL 5MG TO QHS ORAL Date:10/18/01ISR Number: 3811790-0Report Type:Expedited (15-DaCompany Report #A117982 Age:40 YR Gender:Female I/FU:F Outcome PT Required Chest X-Ray Abnormal Intervention to Dyspnoea Prevent Permanent Electrocardiogram Qt Impairment/Damage Corrected Interval Prolonged Electrocardiogram Qt Prolonged Fluid Retention Oedema Psychotic Disorder Pulmonary Oedema 24-Jun-2005 12:19 PM Page: 1538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Health Ziprasidone Po PS ORAL 160.00 MG Professional TOTAL:BID:ORA L Zyprexa (Olanzapine) SS Celexa (Citalopram) C Xanax (Alprazolam) C Date:10/18/01ISR Number: 3811895-4Report Type:Expedited (15-DaCompany Report #DE_010906845 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS Eli Lilly And Health Company 20 MG/DAY Professional Seroxat (Paroxetine Other Hydrochloride) C Tavor (Lorazepam) C Date:10/18/01ISR Number: 3811896-6Report Type:Expedited (15-DaCompany Report #DE_010906844 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS Eli Lilly And Health Company 30 MG/DAY Professional Other Date:10/18/01ISR Number: 3811897-8Report Type:Expedited (15-DaCompany Report #US_010871419 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa (Olanzapine) PS Eli Lilly And Life-Threatening Cardiac Arrest Health Company 10 MG/DAY Other Dyspnoea Professional Seroquel C Hypopnoea Company Contomin Oliguria Representative (Chlorpromazine Oxygen Saturation Hydrochloride) C Decreased Serenace Respiratory Failure (Haloperidol) C Vomiting Artane (Trihexyphenidyl Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Silece (Flunitrazepam) C Mecobalamin C Juvela (Tocopherol) C Ubretid (Distigmine Bromide) C Halomonth (Haloperidol Decanoate) C 24-Jun-2005 12:19 PM Page: 1539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3811912-1Report Type:Expedited (15-DaCompany Report #US_011074944 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Celexa (Citalopram Blood Pressure Increased Hydrobromide) C Heart Rate Irregular Hyperhidrosis Neuroleptic Malignant Syndrome Oedema Peripheral Pallor Pyrexia Rhabdomyolysis Date:10/18/01ISR Number: 3811914-5Report Type:Expedited (15-DaCompany Report #US_011074914 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilic Pneumonia Health Zyprexa (Olanzapine) PS 2.5 MG/3 DAY Professional Effexor (Venlafaxine Company Hydrochloride) C Representative Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Date:10/18/01ISR Number: 3811919-4Report Type:Expedited (15-DaCompany Report #US_011075155 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa (Olanzapine) PS Ketoacidosis Professional Paxil (Paroxetine Company Hydrochloride) C Representative Tegretol (Carbamazepine) C Date:10/18/01ISR Number: 3811926-1Report Type:Expedited (15-DaCompany Report #US_010973487 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Phosphatase Increased Health Serenace Blood Chloride Abnormal Professional (Haloperidol) C Blood Cholesterol Company Artane Increased Representative (Trihexyphenidyl Blood Sodium Abnormal Other Hydrochloride) C Blood Triglycerides Rohypnol Increased (Flunitrazepam) C Cholelithiasis Amoban (Zopiclone) C Gamma-Glutamyltransferase Somelin Increased (Haloxazolam) C Hyperglycaemia Akineton (Biperiden Platelet Count Abnormal Hydrochloride) C White Blood Cell Count Abnormal 24-Jun-2005 12:19 PM Page: 1540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3812026-7Report Type:Expedited (15-DaCompany Report #US_011075008 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Hirnamin Professional (Levomepromazine) C Company Akineton (Biperiden Representative Hydrochloride) C Other Rohypnol(Flunitrazep am) C Date:10/18/01ISR Number: 3812027-9Report Type:Expedited (15-DaCompany Report #GBS011009544 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa(Olanzapine) PS 20 MG/DAY Headache Health Zyban (Amfebutamone Sudden Death Professional Hydrochloride) C Other Methadone C Lithium Carbonate C Carbimazole C Date:10/18/01ISR Number: 3812035-8Report Type:Expedited (15-DaCompany Report #US_011074928 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Diazepam C Professional Haloperidol C Company Representative Other Date:10/18/01ISR Number: 3812036-XReport Type:Expedited (15-DaCompany Report #US_011074670 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/ DAY Health Impromen( Professional Bromperidol) C Company Representative Other Date:10/18/01ISR Number: 3812040-1Report Type:Expedited (15-DaCompany Report #US_011074672 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autism Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Completed Suicide Health Famotidine C Lethargy Professional Malaise Company Representative Other 24-Jun-2005 12:19 PM Page: 1541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3812074-7Report Type:Expedited (15-DaCompany Report #US_011074834 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Culture Positive Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Diarrhoea Health Disseminated Professional Intravascular Coagulation Company Neuroleptic Malignant Representative Syndrome Other Date:10/18/01ISR Number: 3812086-3Report Type:Expedited (15-DaCompany Report #GBS011009535 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa (Olanzapine) PS 40 MG Decreased Health Professional Other Date:10/19/01ISR Number: 3811467-1Report Type:Direct Company Report # Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Zyprexa (2.5 Mg Tab Hospitalization - Renal Failure Acute X 1) PS 2.5MG @HS X 1 Initial or Prolonged Zyprexa (5mg Tab X 1) SS 5MG @ HS X 1 Amantadine C Celecoxib C Hctz/Triamterene C Valsartan C Bisacodyl C Fosrmonole C Carbidopa/Levodopa C Venlafaxine C Proproxyphene C Methycellulose C Lactulose C Date:10/22/01ISR Number: 3813833-7Report Type:Expedited (15-DaCompany Report #HQ7286218OCT2001 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Morphine Sulfate Intentional Misuse (Morphine Sulfate, Tablet, Extended Release) PS ORAL UNKNOWN, ORAL Olanzapine (Olanzapine) SS Date:10/23/01ISR Number: 3813767-8Report Type:Expedited (15-DaCompany Report #PHRM2001FR01992 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Coma Foreign Initial or Prolonged Convulsion Health Hyponatraemia Professional 24-Jun-2005 12:19 PM Page: 1542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Ludiomil (Maprotiline Hydrochloride) Tablet PS ORAL ORAL Deroxat (Paroxetine Hydrochloride) Unknown SS ORAL ORAL Zyprexa (Olanzapine) Tablet SS ORAL ORAL Date:10/23/01ISR Number: 3814412-8Report Type:Expedited (15-DaCompany Report #HQ7315918OCT2001 Age:50 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Diazepam (Diazepam, Intentional Misuse Unspec) PS Amiloride (Amiloride, ) SS Olanzapine (Olanzapine, ) SS Date:10/24/01ISR Number: 3814012-XReport Type:Expedited (15-DaCompany Report #DE97032923A Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Literature Melperone C Health Verapamil C Professional Other Date:10/24/01ISR Number: 3814014-3Report Type:Expedited (15-DaCompany Report #US_010872415 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged C-Reactive Protein Health Serenace Other Increased Professional (Halperidol) C Condition Aggravated Company Contomin Delusion Representative (Chlorpromazine Fatigue Other Hydrochloride) C Mental Disorder Rohypnol Mouth Ulceration (Flunitrazepam) C Pyrexia Levotomin Red Blood Cell Count (Levomepromazine Decreased Maleate) C Staphylococcal Infection Benzalin Thrombocythaemia (Nitrazepam) C Tongue Discolouration Vomiting White Blood Cell Count Decreased 24-Jun-2005 12:19 PM Page: 1543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/01ISR Number: 3814017-9Report Type:Expedited (15-DaCompany Report #US_010973893 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Condition Aggravated Health Haloperidol C Delusion Professional Levomepromazine C Eating Disorder Company Fluphenazine C Hallucination, Auditory Representative Promethazine Insomnia Other Hydrochloride C White Blood Cell Count Magnesium Oxide C Decreased Sennoside A+B C Date:10/24/01ISR Number: 3814020-9Report Type:Expedited (15-DaCompany Report #CA_010603802 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY 3 MON Polyuria Health Valproate Sodium C Professional Topimax(Topiramate) C Other Date:10/24/01ISR Number: 3814228-2Report Type:Expedited (15-DaCompany Report #US_010871911 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Health Zyprexa (Olanzapine) PS 30 MG/DAY Life-Threatening Ecchymosis Professional Synthroid Hospitalization - Hepatic Failure Company (Levothyroxine Initial or Prolonged Neuroleptic Malignant Representative Sodium) SS Syndrome Clonazepam C Renal Failure Colace (Docusate Respiratory Failure Sodium) C Simethicone C Chronulac (Lactulose) C Zoloft (Sertraline Hydrochloride) C Date:10/24/01ISR Number: 3814255-5Report Type:Expedited (15-DaCompany Report #US_011075229 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Feeling Abnormal Ativan (Lorazepam) C Hip Fracture Nervousness Weight Decreased Date:10/24/01ISR Number: 3814258-0Report Type:Expedited (15-DaCompany Report #US_011074942 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Zyprexa (Olanzapine) PS 10 MG/DAY Grand Mal Convulsion Professional Risperdal Laceration (Risperidone) C Subdural Haematoma Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 1544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Benadryl (Diphenhydramine Hydrochloride) C Ibuprofen C Date:10/24/01ISR Number: 3814259-2Report Type:Expedited (15-DaCompany Report #US_011075105 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Zyprexa (Olanzapine) PS 10 MG/1 DAY Risperdal (Risperidone) C Ziprasidone C Topomax (Topiramate) C Carbamazepine C Erythromycin C Date:10/24/01ISR Number: 3814261-0Report Type:Expedited (15-DaCompany Report #US_011075166 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zyprexa (Olanzapine) PS 15 MG/DAY Drug Level Changed Professional Cellcept (Mycophenolate Mofetil) C Prednisone C Depakote (Valproage Semisodium) C Ganciclovir C Clonazepam C Date:10/24/01ISR Number: 3814263-4Report Type:Expedited (15-DaCompany Report #US_011075206 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Hip Fracture Professional Zoloft (Sertraline Initial or Prolonged Company Hydrochloride) C Other Representative Keflex (Cefalexin Monohydrate) C Date:10/24/01ISR Number: 3814265-8Report Type:Expedited (15-DaCompany Report #US_011075213 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Zyprexa (Olanzapine) PS 10 MG/DAY Other Professional Prozac (Fluoxetine Company Hydrochloride) SS Representative Humulin-Human Insulin (Rdna) Unknown Formulation (Hu SS 24-Jun-2005 12:19 PM Page: 1545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/01ISR Number: 3814337-8Report Type:Expedited (15-DaCompany Report #US_010973086 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Hyponatraemia Health Tegretol Purpura Professional (Carbamazepine) C Company Selenica-R Representative (Valproate Sodium) C Other Akineton (Biperiden Hydrochloride) C Marzulene S C Magnesium Oxide C Date:10/24/01ISR Number: 3814340-8Report Type:Expedited (15-DaCompany Report #EWC010928307 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Hospitalization - Dialysis Health Cisordinol Initial or Prolonged Overdose Professional (Clopenthixol Renal Failure Company Hydrochloride) C Schizophrenia Representative Nozinan Sepsis Other (Levomepromazine) C Magnesia (Magnesium Oxide) C Ferro Duretter (Ferrous Sulfate) C Date:10/24/01ISR Number: 3814342-1Report Type:Expedited (15-DaCompany Report #DE_010906726 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa (Olanzapine) PS 10 MG/4 DAY Initial or Prolonged Pulmonary Embolism Health Atosil Vena Cava Thrombosis Professional (Isopromethazine Venous Occlusion Other Hydrochloride) C Date:10/24/01ISR Number: 3814344-5Report Type:Expedited (15-DaCompany Report #US_011074672 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Suicidal Ideation Health Famotidine C Professional Company Representative Other Date:10/24/01ISR Number: 3814345-7Report Type:Expedited (15-DaCompany Report #US_011075008 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Death Cardio-Respiratory Arrest Foreign Completed Suicide Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 1546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10MG/DAY Hirnamin (Levomepromazine) C Akineton (Biperiden Hydrochloride) C Rohypnol (Flunitrazepam) C Serenace (Haloperidol) C Wintermin (Chlorpromazine Hydrochloride) C Pursennid (Senna Leaf) C Olopatadine Hydrochloride C Date:10/24/01ISR Number: 3814610-3Report Type:Expedited (15-DaCompany Report #US_011075194 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Olanzapine PS 5 MG DAY 17 DAY Neutropenia Literature Schizophrenia Health White Blood Cell Count Professional Decreased Other Date:10/24/01ISR Number: 3814612-7Report Type:Expedited (15-DaCompany Report #EWC011028613 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Olanzapine PS 5 MG DAY Increased Health Lithium C Blood Glucose Increased Professional Blood Triglycerides Company Increased Representative Electrocardiogram Qt Other Corrected Interval Glycosuria High Density Lipoprotein Decreased Laboratory Test Abnormal Urine Abnormality White Blood Cells Urine Positive Date:10/24/01ISR Number: 3814614-0Report Type:Expedited (15-DaCompany Report #EWC011028572 Age:26 YR Gender:Female I/FU:I Outcome PT Life-Threatening Coma Hospitalization - Hepatic Enzyme Increased Initial or Prolonged Intentional Misuse Lower Respiratory Tract Infection 24-Jun-2005 12:19 PM Page: 1547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Rhabdomyolysis Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine PS Health Alprazolam C Professional Other Date:10/24/01ISR Number: 3814615-2Report Type:Expedited (15-DaCompany Report #EWC010928333 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Olanzapine PS 5 MG DAY Initial or Prolonged Bladder Disorder Health Risperdal C-Reactive Protein Professional (Risperidone) C Increased Other Aspegic Constipation (Acetylsalicylate Faecaloma Lysine) C Infection Inhibace Plus C Myalgia Pyrexia Respiratory Disorder Sedation Date:10/24/01ISR Number: 3814740-6Report Type:Expedited (15-DaCompany Report #FR_011000235 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Increased Health Xanax (Alprazolam) C Arterial Thrombosis Professional Effexor (Venlafaxine Blood Lactate Company Hydrochloride) C Dehydrogenase Increased Representative Cerebrovascular Accident Other Hemiplegia Platelet Count Decreased Retinopathy Date:10/24/01ISR Number: 3814762-5Report Type:Expedited (15-DaCompany Report #US_011075387 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Zyprexa (Olanzapine) PS 280 MG/DAY Initial or Prolonged Overdose Health Seroquel C Rhabdomyolysis Professional Halcion (Triazolam) C Company Rohypnol Representative (Flunitrazepam) C Other Date:10/24/01ISR Number: 3814864-3Report Type:Expedited (15-DaCompany Report #FR_011000220 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Neutropenia Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 1548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG/DAY Date:10/24/01ISR Number: 3814983-1Report Type:Expedited (15-DaCompany Report #US_010973387 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ammonia Increased Health Prozac (Fluoxetine Bipolar Disorder Professional Hydrochloride) PS 20 MG DAY Hepatic Neoplasm Zyprexa (Olanzapine) SS 2.5 MG/AT Malignant BEDTIME 1 WK Mental Disorder Due To A Aldactone General Medical Condition (Spironolactone) C Atenolol C Synthroid (Levothyroxine Sodium) C Date:10/24/01ISR Number: 3815016-3Report Type:Expedited (15-DaCompany Report #US_010566463 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Consumer Zyprexa (Olanzapine) PS 10 MG/1 AT Initial or Prolonged Diabetes Mellitus BEDTIME Other Diabetic Hyperosmolar Stelazine Coma (Trifluoperazine Dizziness Hydrochloride) C Dry Mouth Fatigue Hypovolaemia Nausea Pancreatitis Acute Pneumonia Pyrexia Renal Failure Acute Sedation Weight Decreased White Blood Cell Count Increased Date:10/24/01ISR Number: 3815018-7Report Type:Expedited (15-DaCompany Report #US_010770342 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa Zydis Professional (Olanzapine) PS 20 MG/DAY Company Depakote (Valproate Representative Semisodium) C Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 1549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/01ISR Number: 3815019-9Report Type:Expedited (15-DaCompany Report #US_010770346 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa (Olanzapine) PS 40 MG/DAY White Blood Cell Count Professional Depakote (Valproate Decreased Company Semisodium) C Representative Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Klonopin (Clonazepam) C Date:10/24/01ISR Number: 3815096-5Report Type:Expedited (15-DaCompany Report #US_011074903 Age:58 YR Gender:Male I/FU:I Outcome PT Death Abdominal Pain Other Abnormal Behaviour Agitation Anxiety Aspartate Aminotransferase Increased Blood Albumin Increased Blood Calcium Increased Blood Chloride Increased Blood Creatine Phosphokinase Increased Blood Phosphorus Increased Blood Potassium Increased Blood Pressure Increased Blood Sodium Increased Cardiac Arrest Coma Constipation Delirium Dysuria Excoriation Haematuria Heart Rate Increased Hostility Insomnia Judgement Impaired Lethargy Lung Infiltration Metabolic Acidosis Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Proteinuria Prothrombin Time Prolonged Pyrexia Renal Failure Respiratory Acidosis Respiratory Rate Increased 24-Jun-2005 12:19 PM Page: 1550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stupor Suicidal Ideation Tachypnoea Report Source Product Role Manufacturer Route Dose Duration Urinary Casts Literature Olanzapine PS White Blood Cell Count Health Fluoxetine Increased Professional (Fluoxetine Hydrochloride) SS Nortriptyline C Zolpidem C Gabapentin C Multivitamins C Laxative C Date:10/24/01ISR Number: 3815276-9Report Type:Expedited (15-DaCompany Report #DE_990100814 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS Health Professional Other Date:10/24/01ISR Number: 3815277-0Report Type:Expedited (15-DaCompany Report #DE_990100804 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Decreased Health Professional Other Date:10/24/01ISR Number: 3815279-4Report Type:Expedited (15-DaCompany Report #DE_011007024 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Zyprexa (Olanzapine) PS 10 MG/IN THE Medication Error Health EVENING Metrorrhagia Professional Valette C Other Date:10/24/01ISR Number: 3815288-5Report Type:Expedited (15-DaCompany Report #DE97045593A Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 15 MG DAY Neutropenia Health Professional Other Date:10/24/01ISR Number: 3815294-0Report Type:Expedited (15-DaCompany Report #DE96122041A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Leukopenia Foreign Health Professional 24-Jun-2005 12:19 PM Page: 1551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG Melperone C Date:10/24/01ISR Number: 3815296-4Report Type:Expedited (15-DaCompany Report #DE97065443A Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa (Olanzapine) PS 20 MG DAY 4 MON Initial or Prolonged Leukopenia Health Professional Other Date:10/24/01ISR Number: 3815360-XReport Type:Expedited (15-DaCompany Report #US_000846653 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abscess Study Olanzapine PS Eli Lilly And Life-Threatening Arthropathy Health Company 6 MG Hospitalization - Atrial Fibrillation Professional Fluoxetine Initial or Prolonged Blood Albumin Decreased (Fluoxetine Blood Fibrinogen Hydrochloride) SS 75 MG Increased Humalog (Insulin Blood Lactic Acid Lispro) C Increased Ultralente Insulin Blood Magnesium Decreased (Insulin Zinc Calculus Ureteric Suspension) C Cholelithiasis Asa (Acetylsalicylic Difficulty In Walking Acid) C Disseminated Multivitamin C Intravascular Coagulation Ferrous Sulfate C Dysarthria Fatigue Haematocrit Decreased Hypokalaemia Hypotension Liver Function Test Abnormal Nephrolithiasis Neutropenia Oedema Osteomyelitis Pain In Extremity Pulmonary Oedema Renal Failure Acute Respiratory Failure Rhabdomyolysis Staphylococcal Sepsis Tachycardia Thrombocytopenia Toxic Epidermal Necrolysis Urography Abnormal 24-Jun-2005 12:19 PM Page: 1552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/01ISR Number: 3815363-5Report Type:Expedited (15-DaCompany Report #US_011075445 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa (Olanzapine) PS Eli Lilly And Decreased Professional Company Date:10/26/01ISR Number: 3816416-8Report Type:Direct Company Report # Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Zyphrexa PS Lotensin C Aspirin C Multivitamins C Vitamin E And D C Date:10/29/01ISR Number: 3817149-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL 6 MG, DAILY, Professional ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 150 MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 300 MG, DAILY, ORAL Olanzapine (Olanzapine) SS ORAL 5 MG, DAILY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Teprenone (Teprenone) C Date:10/30/01ISR Number: 3819367-8Report Type:Periodic Company Report #CIP01000572 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Asacol(Mesalamine)Ta Depression Professional blet, 400mg PS ORAL SEE IMAGE Obsessive Thoughts Rythmol "Biosedra" Prostate Cancer (Propafenone) SS Biosedra ORAL 300 MG 3 TIMES DAILY, ORAL Digoxin (Digoxin) SS ORAL 0.25 MG DAILY, ORAL 24-Jun-2005 12:19 PM Page: 1553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin (Clonazepam) SS ORAL 0.5 MG TWICE DAILY, ORAL Paxil (Paroxetine Hydrochloride) SS ORAL 4 MG DIALY, ORAL Zyprexa (Olanzapine) Tablet, 2.5 Tablet SS ORAL 0.6 MG DAILY, ORAL Folic Acid (Folic Acid) C B Complex (Nicotinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine C Acetylsalicylic Acid (Acetylsalicylic Acid) C Multivitamins (Folic Acid, Nicotinamide,Panthen ol, Retinol, Riboflavin, Thiamine C Date:10/31/01ISR Number: 3817278-5Report Type:Expedited (15-DaCompany Report #A0162401A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Zyban PS Glaxo Wellcome ORAL Initial or Prolonged Mood Swings Topamax SS UNKNOWN Suicidal Ideation Zyprexa SS UNKNOWN Klonopin SS UNKNOWN Ziprasidone SS UNKNOWN Depakote SS UNKNOWN Date:10/31/01ISR Number: 3818049-6Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Olanzapine (Zyprexa) PS ORAL 5MG PO HS Electrocardiogram Ect C Abnormal Clonazepam C Tachycardia Gabapentin C Date:10/31/01ISR Number: 3818159-3Report Type:Expedited (15-DaCompany Report #US_011075562 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa Olanzapine PS 5 YR Life-Threatening Dyspnoea Professional Hospitalization - Hyperglycaemia Initial or Prolonged Ventricular Fibrillation 24-Jun-2005 12:19 PM Page: 1554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/01ISR Number: 3818160-XReport Type:Expedited (15-DaCompany Report #US_011075563 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Compartment Syndrome Health Zyprexa (Olanzapine) PS 20 MG/DAY 1 YR Muscle Spasms Professional Prozac (Fluoxetine Pain In Extremity Hydrochloride) SS 40 MG/1 DAY Weight Increased Risperdal (Risperidone) C Lipitor (Atorvastatin) C Date:10/31/01ISR Number: 3818168-4Report Type:Expedited (15-DaCompany Report #FR_011000267 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Seropram (Citalopram Professional Hydrobromide) C Other Date:10/31/01ISR Number: 3818169-6Report Type:Expedited (15-DaCompany Report #FR_011000262 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Epistaxis Health Professional Other Date:10/31/01ISR Number: 3818176-3Report Type:Expedited (15-DaCompany Report #GBS011009592 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sinoatrial Block Foreign Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Health Carbamazepine C Professional Ferrous Sulfate Other Exsiccated C Date:10/31/01ISR Number: 3818177-5Report Type:Expedited (15-DaCompany Report #GBS011009602 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Olanzapine PS 10 MG/DAY Initial or Prolonged Prolonged Health Aspirin C Other Professional Venlafaxine C Other Frusemide C Diazepam C Lansoprazole C Date:10/31/01ISR Number: 3818179-9Report Type:Expedited (15-DaCompany Report #US_010973857 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Life-Threatening Rhabdomyolysis Foreign Hospitalization - Health Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 1555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG/DAY Melleril (Thioridazine Hydrochloride) C Serenace (Haloperidol) C Rohypnol (Flunitrazepam) C Amoban (Zopiclone) C Meptin (Procaterol Hydrochloride0 C Almeta (Alclometasone Dipropionate) C Methaderm (Dexamethasone Dipropionate) C Date:10/31/01ISR Number: 3818184-2Report Type:Expedited (15-DaCompany Report #US_011075501 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Pyrexia Health Akineton (Biperiden Professional Hydrochloride0 C Company Etizolam C Representative Rohypnol Other (Flunitrazepam) C Date:10/31/01ISR Number: 3818185-4Report Type:Expedited (15-DaCompany Report #US_011075722 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Other Condition Aggravated Health Haloperidol C Dystonia Professional Tolopelon Myocardial Ischaemia Company (Timiperone) C Speech Disorder Representative Risperidone C Developmental Other Levotomin (Levomepromazine Maleate) C Depakene (Valproate Sodium) C Tasmolin (Biperiden) C Date:10/31/01ISR Number: 3818334-8Report Type:Expedited (15-DaCompany Report #DE_011007083 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delirium Foreign Zyprexa (Olanzapine) PS 10 MG/IN THE Hospitalization - Pancytopenia Health EVENING Initial or Prolonged Sepsis Professional Omeprazole C Staphylococcal Infection Other Delix (Ramipril) C Chloraldurat (Chloral Hydrate) C 24-Jun-2005 12:19 PM Page: 1556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Furosemid (Furosemide) C Date:10/31/01ISR Number: 3818336-1Report Type:Expedited (15-DaCompany Report #GBS011009590 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa (Olanzapine) PS 10 MG Second Degree Health Professional Other Date:10/31/01ISR Number: 3818398-1Report Type:Expedited (15-DaCompany Report #US_011075503 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Olanzapine PS 20 MG/DAY Literature Quetiapine C Health Professional Other Date:10/31/01ISR Number: 3818431-7Report Type:Expedited (15-DaCompany Report #US_011075857 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Dyspnoea Professional Furosemide C Other Lisinopril C Spironolactone C Losartan C Depakote (Valproate Semisodium) C Lipitor (Atorvastatin) C Aspirin C Levothyroxine C Date:10/31/01ISR Number: 3818433-0Report Type:Expedited (15-DaCompany Report #US_011075894 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Literature Zyprexa (Olanzapine) PS Coma Health Benztropine C Drug Level Above Professional Lorazepam C Therapeutic Clonazepam C Drug Toxicity Ecchymosis Excoriation Laceration Pulmonary Congestion Pulmonary Oedema Spleen Disorder Testicular Disorder 24-Jun-2005 12:19 PM Page: 1557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/01ISR Number: 3818524-4Report Type:Expedited (15-DaCompany Report #EWC011028709 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Olanzapine PS 1 MG/DAY Initial or Prolonged Vomiting Study Tenormine (Atenolol) C Health Skenan (Morphine Professional Sulfate) C Other Calcite D C Exelon (Rivastigmine Tartrate) C Motilium (Domperidone) C Imuline 830 C Date:10/31/01ISR Number: 3818525-6Report Type:Expedited (15-DaCompany Report #US_010769189 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Increased Health Tasmolin (Biperiden) C Aspartate Professional Aminotransferase Company Increased Representative Blood Cholesterol Other Increased Fatigue Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Inflammation Leukopenia Nasopharyngitis Respiratory Disorder Sedation Thrombocytopenia Date:10/31/01ISR Number: 3818526-8Report Type:Expedited (15-DaCompany Report #US_010973893 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Condition Aggravated Health Haloperidol C Delusion Professional Levomepromazine C Hallucination, Auditory Company Fluphenazine C Insomnia Representative Promethazine Mental Disorder Other Hydrochloride C Middle Insomnia Magnesium Oxide C White Blood Cell Count Sennoside A+B C Decreased Date:10/31/01ISR Number: 3818527-XReport Type:Expedited (15-DaCompany Report #EWC010827988 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Phosphokinase Increased Health Anafranil Other Condition Aggravated Professional (Clomipramine Hepatitis Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor (Venlafaxine Hydrochloride) C Seresta (Oxazepam) C Rivotril (Clonazepam) C Tercian (Cyamemazine) C Akineton (Biperiden Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Imovane (Zopiclone) C Levothyrox (Levothyroxine Sodium) C Kaleorid (Potassium Chloride) C Lisanxia C Yohimbine C Date:10/31/01ISR Number: 3818537-2Report Type:Expedited (15-DaCompany Report #US_010872376 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Hospitalization - Blood Albumin Decreased Health Gramalil (Tiapride Initial or Prolonged Bronchospasm Professional Hydrochloride) C Dehydration Company Serenace Faecal Incontinence Representative (Haloperidol) C Fall Other Akineton (Biperiden Heart Rate Increased Hydrochloride) C Injury Ubretid (Distigime Pancytopenia Bromide) C Protein Total Decreased Artane Pyrexia (Trihexyphenidyl Sepsis Hydrochloride) C Amoban (Zopiclone) C Date:10/31/01ISR Number: 3818538-4Report Type:Expedited (15-DaCompany Report #US_011074672 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Haemorrhage Health Famotidine C Shock Professional Suicidal Ideation Company Representative Other Date:10/31/01ISR Number: 3818539-6Report Type:Expedited (15-DaCompany Report #US_011074834 Age:67 YR Gender:Male I/FU:F Outcome PT Life-Threatening Anorexia Hospitalization - Blood Culture Positive Initial or Prolonged Cyanosis Other Dehydration 24-Jun-2005 12:19 PM Page: 1559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Disseminated Intravascular Coagulation Report Source Product Role Manufacturer Route Dose Duration Haematochezia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Haemorrhagic Diathesis Health Risperdal Multi-Organ Failure Professional (Risperidone) C Neuroleptic Malignant Company Depas (Etizolam) C Syndrome Representative Halcion (Triazolam) C Oedema Other Levotomin Pancytopenia (Levomepromazine Pyrexia Maleate) C Dogmatyl (Sulpiride) C Sepazon (Cloxazolam) C Fluphenazine C Date:10/31/01ISR Number: 3818653-5Report Type:Expedited (15-DaCompany Report #GBS000205507 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa (Olanzapine) PS 10 MG Chest Pain Consumer Cough Health Cyst Professional Dermatitis Company Dry Mouth Representative Eosinophil Count Other Increased Gastroenteritis Hypersensitivity Influenza Ovarian Enlargement Pleural Effusion Pleural Infection Pulmonary Alveolar Haemorrhage Pulmonary Congestion Scratch Skin Ulcer Snoring Sudden Death Vomiting Weight Increased Date:10/31/01ISR Number: 3818654-7Report Type:Expedited (15-DaCompany Report #FR_010700095 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Tercian Professional (Cyamemazine) C Other Date:10/31/01ISR Number: 3818655-9Report Type:Expedited (15-DaCompany Report #FR_011000220 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Neutropenia Foreign Health 24-Jun-2005 12:19 PM Page: 1560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG/DAY Date:10/31/01ISR Number: 3818730-9Report Type:Expedited (15-DaCompany Report #US_010974040 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decreased Appetite Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Dehydration Health Risperdal Initial or Prolonged Depressed Level Of Professional (Risperidone) C Other Consciousness Company Artane Diabetic Coma Representative (Trihexyphenidyl Hyperglycaemia Other Hydrochloride) C Pharyngitis Rohypnol Polydipsia (Flunitrazepam) C Halcion (Triazolam) C Date:10/31/01ISR Number: 3819207-7Report Type:Expedited (15-DaCompany Report #US_011075453 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Olanzapine PS 35 MG/DAY 3 YR Other Escherichia Infection Literature Lithium Carbonate C Pneumonia Health Quetiapine C Psychotic Disorder Professional Pyrexia Other Sepsis Tonsillitis Date:10/31/01ISR Number: 3819274-0Report Type:Expedited (15-DaCompany Report #AU_001002047 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Adhesions Foreign Olanzapine PS Initial or Prolonged Abdominal Pain Study Celebrex (Celecoxib) C Blood Uric Acid Increased Health Diamiciron Diarrhoea Professional (Gliclazide) C Gamma-Glutamyltransferase Other Increased Haemoglobin Decreased Leukopenia Platelet Count Decreased Pyrexia Vomiting Date:11/01/01ISR Number: 3817965-9Report Type:Expedited (15-DaCompany Report #300478 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Necrosis Rivotril PS Roche Initial or Prolonged Zyprexa SS Tegretol SS Tranxene C 24-Jun-2005 12:19 PM Page: 1561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/01ISR Number: 3819838-4Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Zyprexa PS 7 OR MORE Hospitalization - Tremor DAILEY Initial or Prolonged Disability Congenital Anomaly Required Intervention to Prevent Permanent Impairment/Damage Date:11/05/01ISR Number: 3820507-5Report Type:Expedited (15-DaCompany Report #02675 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Diazepam PS Intentional Misuse Olanzapine SS Amiloride SS Date:11/05/01ISR Number: 3820704-9Report Type:Expedited (15-DaCompany Report #02611 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Carbamazepine PS Intentional Misuse Bupropion SS Olanzepine SS Date:11/05/01ISR Number: 3820746-3Report Type:Expedited (15-DaCompany Report #02613 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonazepam PS Intentional Misuse Bupropion SS Olanzepine SS Date:11/05/01ISR Number: 3820763-3Report Type:Expedited (15-DaCompany Report #02663 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Alprazolam PS Intentional Misuse Bupropion SS Olanzapine SS Date:11/05/01ISR Number: 3820803-1Report Type:Expedited (15-DaCompany Report #02620 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Trazodone PS Paroxetine SS Olanzapine SS 24-Jun-2005 12:19 PM Page: 1562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/01ISR Number: 3820856-0Report Type:Expedited (15-DaCompany Report #02684 Age:30 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Trazodone PS Amphetamine SS Olanzapine SS Date:11/05/01ISR Number: 3821978-0Report Type:Expedited (15-DaCompany Report #300478 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Necrosis Foreign Rivotril Initial or Prolonged Other (Clonazepam) PS ORAL 6 MG DAILY ORAL Zyprexa (Olanzapine) SS ORAL 20 MG DAILY ORAL Tegretol (Carbamazepine) 400 Mg SS ORAL 800 MG DAILY ORAL Tranxene (Clorazepate Dipotassium) C Date:11/06/01ISR Number: 3820736-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatotoxicity Zyprexa PS 5MG BID ON Initial or Prolonged 10/12 INCREASED 5MG AM, 10MG HS ON 10-16 Klonopin SS 1MG BID Date:11/06/01ISR Number: 3821638-6Report Type:Expedited (15-DaCompany Report #02678 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Morphine Sr PS Suicide Attempt Olanzapine SS Date:11/07/01ISR Number: 3822082-8Report Type:Expedited (15-DaCompany Report #A044-002-003326 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Aricept (Donepezil) PS ORAL SEE IMAGE Initial or Prolonged Posture Abnormal Health Zyprexa (Olanzapine) SS ORAL SEE IMAGE Professional Ritalin (Methylphenidate Hydrochloride) SS ORAL SEE IMAGE Thrombran (Trazodone Hydrochloride) C Ass (Acetylsalicylic Acid) C 24-Jun-2005 12:19 PM Page: 1563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3822384-5Report Type:Expedited (15-DaCompany Report #US_000846653 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthritis Infective Study Olanzapine PS 6 MG Life-Threatening Arthropathy Health Fluoxetine Hospitalization - Atrial Fibrillation Professional (Fluoxetime Initial or Prolonged Blood Culture Positive Hydrochloride) SS 75 MG Culture Urine Positive Humalog (Insuliin Disseminated Lispro) C Intravascular Coagulation Ultralente Insulin Haematocrit Decreased (Insulin Zinc Hypokalaemia Suspension) C Hypotension Asa (Acetylsalicylic Liver Function Test Acid) C Abnormal Multivitamin C Metabolic Acidosis Ferrous Sulfate C Oedema Renal Impairment Respiratory Alkalosis Respiratory Distress Rhabdomyolysis Sepsis Staphylococcal Infection Staphylococcal Sepsis Thrombocytopenia Toxic Epidermal Necrolysis Date:11/07/01ISR Number: 3822400-0Report Type:Expedited (15-DaCompany Report #A124796 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Consumer Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Condition Aggravated TOTAL DAILY Difficulty In Walking ORAL Hostility Zyprexa SS Muscle Spasms Benadryl C Speech Disorder Calcium C Stupor Synthroid C Tension Detrol C Depakote C Calcitriol C Lamictal C Risperdal C Date:11/07/01ISR Number: 3823261-6Report Type:Expedited (15-DaCompany Report #US_010769559 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Phosphokinase Increased Health Haloperidol C Delusion Professional Chlorpromazine C Medication Error Company Levomepromazine C Oedema Representative Griseofulvin C Renal Failure Acute Other Cetapril (Alacepril) C Adalat (Nifedipine) C 24-Jun-2005 12:19 PM Page: 1564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3823272-0Report Type:Expedited (15-DaCompany Report #US_011075501 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Zyprexa (Olanzapine) PS 20MG/DAY Initial or Prolonged Increased Akineton (Bipiriden Hepatitis Hydrochloride) C Malaise Etizolam C Pyrexia Rohypnol (Flunitrazepam) C Levotomin (Levopromazine Maleate) C Magnesium Oxide C Date:11/07/01ISR Number: 3823273-2Report Type:Expedited (15-DaCompany Report #US_011075722 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa (Olanzapine) PS 20MG/DAY Other Condition Aggravated Health Haloperidol C Coronary Artery Disease Professional Tolopelon Dystonia Company (Tiiperone) C Speech Disorder Representative Risperidone C Other Levotomin (Levomepromazine Maleate) C Depakene (Valproate Sodium) C Tasmolin (Biperiden) C Date:11/07/01ISR Number: 3823274-4Report Type:Expedited (15-DaCompany Report #DE_011007112 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zypexa (Olanzapine) PS 15MG/DAY Eating Disorder Health Carbamazepine C Leukopenia Professional Trimipramine C Weight Decreased Other Date:11/07/01ISR Number: 3823342-7Report Type:Expedited (15-DaCompany Report #US_010973861 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Hospitalization - Professional Initial or Prolonged Company Representative Date:11/07/01ISR Number: 3823346-4Report Type:Expedited (15-DaCompany Report #US_011076076 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Road Traffic Accident Consumer Zyprexa (Olanzapine) PS Wellbutrin (Amfebutamone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3823348-8Report Type:Expedited (15-DaCompany Report #US_011076070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Zyprexa (Olanzapine) PS Asthma Hypersensitivity Date:11/07/01ISR Number: 3823351-8Report Type:Expedited (15-DaCompany Report #US_011075909 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged White Blood Cell Count Professional Clozapine C Decreased Other White Blood Cell Count Increased Date:11/07/01ISR Number: 3823637-7Report Type:Expedited (15-DaCompany Report #EWC011028675 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Depressed Level Of Health Tegretol Consciousness Professional (Carbamazepine) C Facial Palsy Other Rohypnol Haemorrhage Intracranial (Flunitrazepam) C Hemiparesis Hemiplegia Hypoaesthesia Sedation Date:11/07/01ISR Number: 3823638-9Report Type:Expedited (15-DaCompany Report #DE_011007115 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Valproic Acid C Professional Other Date:11/07/01ISR Number: 3823639-0Report Type:Expedited (15-DaCompany Report #DE_001003186 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 15 MG/2 DAY Neutrophil Count Abnormal Health Tavor (Lorazepam) C White Blood Cell Count Professional Radedorm Decreased Other (Nitrazepam) C Date:11/07/01ISR Number: 3823955-2Report Type:Expedited (15-DaCompany Report #US_011076451 Age: Gender:Male I/FU:I Outcome PT Report Source Other Drug Eruption Foreign Hepatitis Health Professional 24-Jun-2005 12:19 PM Page: 1566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Date:11/07/01ISR Number: 3823964-3Report Type:Expedited (15-DaCompany Report #US_011076449 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Health Zyprexa (Olanzapine) PS Initial or Prolonged Sepsis Professional Other Company Representative Date:11/07/01ISR Number: 3823965-5Report Type:Expedited (15-DaCompany Report #US_011076225 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Bile Duct Stone Health Vomiting Professional Other Date:11/07/01ISR Number: 3823966-7Report Type:Expedited (15-DaCompany Report #GBS011009647 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS Increased Health Chlorpromazine C Aspartate Professional Paracetamol C Aminotransferase Other Haloperidol C Increased Lorazepam C Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Increased Jaundice Date:11/07/01ISR Number: 3823967-9Report Type:Expedited (15-DaCompany Report #GBS011009652 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zyprexa (Olanzapine) PS 5 MG/2 DAY Hospitalization - Consciousness Health Mirtazapine C Initial or Prolonged Respiratory Failure Professional Adalat La C Other Simvastatin C Atenolol C Lisinopril C Metformin C Date:11/07/01ISR Number: 3824004-2Report Type:Expedited (15-DaCompany Report #EWC011028803 Age:14 YR Gender:Female I/FU:I Outcome PT Bone Marrow Depression Haemoglobin Decreased 24-Jun-2005 12:19 PM Page: 1567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Count Decreased Weight Decreased White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Foreign Zyprexa (Olanzapine) PS Health Zoloft (Sertraline Professional Hydrochloride) C Other Propavan (Propiomazine Maleate) C Stilnoct (Zolpidem Tartrate) C Stesolid (Diazepam) C Flagyl (Metronidazole) C Kavepenin (Phenoxymethylpenici llin Potassium) C Date:11/07/01ISR Number: 3824134-5Report Type:Expedited (15-DaCompany Report #DE97065443A Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Zyprexa (Olanzapine) PS 20 MG DAY 4 MON Initial or Prolonged Leukopenia Health Professional Other Date:11/07/01ISR Number: 3824167-9Report Type:Expedited (15-DaCompany Report #DE_990100804 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Decreased Health Professional Other Date:11/07/01ISR Number: 3824168-0Report Type:Expedited (15-DaCompany Report #EWC010928302 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Olanzapine PS 600 MG/DAY Initial or Prolonged Phosphatase Decreased Health Xanax (Alprazolam) C Other Blood Calcium Decreased Professional ... C Blood Phosphorus Other .... C Increased ... C Blood Sodium Decreased ... C Depressed Level Of .... C Consciousness Intentional Misuse Nerve Compression Paraesthesia Protein Total Decreased Renal Impairment Rhabdomyolysis Suicide Attempt 24-Jun-2005 12:19 PM Page: 1568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3824169-2Report Type:Expedited (15-DaCompany Report #US_010973086 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Blood Creatine Health Tegretol Phosphokinase Increased Professional (Carbamazepine) C Blood Lactate Company Selencia-R Dehydrogenase Increased Representative (Valproate Sodium) C Condition Aggravated Other Akineton (Biperiden Ecchymosis Hydrochloride) C Hyponatraemia Marzulene S C Muscle Injury Magnesium Oxide C Platelet Count Decreased Purpura Date:11/07/01ISR Number: 3824315-0Report Type:Expedited (15-DaCompany Report #US_011076452 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Humulin-Human Cerebrovascular Accident Insulin (Rdna): 30% Crying Regular, 70% Nph (H PS 7 YR Diabetes Mellitus Prozac (Fluoxetine Diabetes Mellitus Hydrochloride) SS Inadequate Control Zyprexa (Olanzapine) SS 2.5 MG/DAY Feeling Abnormal Humalog-, (Lispro) SS 1 WK Fibromyalgia Glucophage Mood Swings (Metformin Myocardial Infarction Hydrochloride) C Screaming Actos "Takeda" Sedation (Pioglitazone) C Sleep Walking Klor-Con (Potassium Swelling Chloride) C Furosemide C Prednisone C Coumadin (Warfarin Sodium) C Temazepam C Hyzaar C Tylenol (Paracetamol) C Oxycontin (Oxycodone Hydrochloride) C Vioxx (Rofecoxib) C Norvasc (Amlodipine Besilate) C Venlafaxine C Date:11/07/01ISR Number: 3824332-0Report Type:Expedited (15-DaCompany Report #US_011076265 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faeces Discoloured Consumer Zyprexa (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 1569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3824333-2Report Type:Expedited (15-DaCompany Report #US_011075861 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa (Olanzapine) PS 2.5 MG/DAY 1 DAY Professional Company Representative Date:11/08/01ISR Number: 3822382-1Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Disorder Zyprexa PS Date:11/08/01ISR Number: 3823240-9Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Zyprexa PS ORAL 10 MG PO QD 10 DAY Abnormal Date:11/09/01ISR Number: 3822725-9Report Type:Direct Company Report # Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Amnesia Zyprexa 20mg PS 20MG 2 TIMES Intervention to Apathy Prevent Permanent Confusional State Impairment/Damage Depression Dyspnoea Flat Affect Major Depression Paraesthesia Date:11/12/01ISR Number: 3825204-8Report Type:Expedited (15-DaCompany Report #PERI00201004598 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Foreign Coversyl Confusional State Health (Perindopril) PS ORAL 8 MG QD PO Convulsion Professional Olanzapine Coordination Abnormal Other (Olanzapine) SS ORAL 10 MG DAILY Dizziness PO Hypertension Hyponatraemia Polydipsia Date:11/13/01ISR Number: 3824653-1Report Type:Expedited (15-DaCompany Report #LBID00201004554 Age:13 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Tenderness Initial or Prolonged Blood Pressure Decreased Body Temperature Increased Differential White Blood 24-Jun-2005 12:19 PM Page: 1570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cell Count Abnormal Fall Haematuria Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration Influenza Literature Lithium Sr (Lithium) PS ORAL 300 MG BID PO Leukocytosis Health Olanzapine Myocardial Infarction Professional (Olanzapine) SS Respiratory Rate (Sertraline) C Increased Rhabdomyolysis Date:11/13/01ISR Number: 3824981-XReport Type:Periodic Company Report #PHEH2001US06136 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Trileptal(Oxcarbazep Increased Professional ine) Tablet PS ORAL 300 MG, TID, Aspartate ORAL Aminotransferase Zyprexa(Olanzapine) SS ORAL 15 MG/QHS + Increased 15 MG/TID, Blood Sodium Decreased ORAL Blood Urea Decreased Celexa (Citalopram Neutrophil Count Hydrobromide) C Decreased Oedema Peripheral Platelet Count Decreased Red Blood Cell Count Decreased White Blood Cell Count Decreased Date:11/13/01ISR Number: 3826153-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE02553 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleurothotonus Foreign Ritaline Initial or Prolonged Study (Methylphenidate Health Hydrochloride) Professional Tablet PS ORAL SEE IMAGE Other Zyprexa (Olanzapine) SS ORAL SEE IMAGE Aricept (Donepezil Hydrochloride) SS ORAL SEE IMAGE Thombran (Trazodone Hydrochloride) C Acetylsalicylate C Date:11/14/01ISR Number: 3825082-7Report Type:Expedited (15-DaCompany Report #2001UW14424 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Other Prilosec PS Initial or Prolonged Condition Aggravated Zyprexa SS Disorientation Eskalith SS Fall Wellbutrin SS 24-Jun-2005 12:19 PM Page: 1571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/01ISR Number: 3826506-1Report Type:Expedited (15-DaCompany Report #EWC011028689 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Professional Company Representative Date:11/16/01ISR Number: 3824937-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Zyprexa PS ORAL 2.5 MG PO Required STAT Intervention to Prevent Permanent Impairment/Damage Date:11/16/01ISR Number: 3824974-2Report Type:Expedited (15-DaCompany Report #WAES 01111497 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Prinivil PS Merck & Co., Inc ORAL Olanzapine SS Mirtazapine SS Date:11/16/01ISR Number: 3825951-8Report Type:Periodic Company Report #PHEH2001US06399 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Exelon Syncope Professional (Rivastigmine) PS Company Zyprexa (Olanzapine) SS Representative Date:11/16/01ISR Number: 3825952-XReport Type:Periodic Company Report #PHEH2001US06400 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Exelon Syncope Professional (Rivastigmine) PS Company Zyprexa (Olanzapine) SS Representative Date:11/16/01ISR Number: 3825987-7Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Zyprexa PS ORAL 12.5 MG PO Hospitalization - QHS Initial or Prolonged Wellbutrin C Required Neurontin C Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 1572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/01ISR Number: 3825366-2Report Type:Expedited (15-DaCompany Report #WAES 01111496 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Midamor PS Merck & Co., Inc ORAL Intentional Misuse Diazepam SS Olanzapine SS Date:11/19/01ISR Number: 3827583-4Report Type:Expedited (15-DaCompany Report #001-0945-M0101301 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Literature Gabapentin Hospitalization - Aggression Health (Gabapentin) PS Initial or Prolonged Agitation Professional Haloperidol Other Aspartate (Haloperidol) SS 15 MG (5 MG, Aminotransferase TID) Increased Olanzapine Blood Albumin Increased (Olanzapine) SS Blood Calcium Decreased Nortriptyline Blood Creatine (Nortriptyline) SS Phosphokinase Increased Zolpedem (Zolpidem) SS Blood Pressure Increased Fluoxetine SS Blood Sodium Increased Multivitamins Cardiac Arrest (Ergocalciferol, Chest X-Ray Abnormal Ascorbic Acid, Folic Constipation Acid, Thiamine Delirium Hydrochloride, SS Dry Skin Unspecified Dysuria Laxatives SS Excoriation Clomipramine Haematuria (Clomipramine) SS 25 MG (DAILY) Haemodialysis Benztropine Headache (Benzatropine Heart Rate Increased Mesilate) SS 4 MG (BID) Insomnia Buspirone Sr Lethargy (Buspirone) SS 100 MG Metabolic Acidosis (DAILY) Multi-Organ Failure Clonazepam Muscle Rigidity (Clonazepam) SS 1.5 MG (TID) Neuroleptic Malignant Syndrome Proteinuria Prothrombin Time Prolonged Renal Failure Respiratory Rate Increased Serotonin Syndrome Tachypnoea Urinary Casts White Blood Cell Count Increased Date:11/19/01ISR Number: 3828235-7Report Type:Expedited (15-DaCompany Report #AU_010102950 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Other Pituitary Tumour Foreign Health 24-Jun-2005 12:19 PM Page: 1573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Olanzapine PS 20 MG/DAY Date:11/19/01ISR Number: 3828236-9Report Type:Expedited (15-DaCompany Report #DE_011007083 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delirium Foreign Zyprexa( Olanzapine) PS 10 MG/IN THE Hospitalization - Pancytopenia Health EVENING Initial or Prolonged Staphylococcal Sepsis Professional Omeprazole C Other Delix(Ramipril) C Chloraldurat (Chloral Hydrate) C Furosemid (Furosemide) C Date:11/19/01ISR Number: 3828238-2Report Type:Expedited (15-DaCompany Report #EWC011028709 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Olanzapine PS 1 MG/DAY Initial or Prolonged Vomiting Study Tenormine (Atenolol) C Health Skenan (Morphine Professional Sulfate) C Other Exelon (Rivastigmine Tartrate) C Motilium (Domperidone) C Date:11/19/01ISR Number: 3828239-4Report Type:Expedited (15-DaCompany Report #US_011074834 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Hospitalization - Blood Creatine Health Risperdal Initial or Prolonged Phosphokinase Increased Professional (Risperidone) C Other Blood Culture Positive Company Depas (Etizolam) C Cyanosis Representative Halcion (Triazolam) C Dehydration Other Levotomin Depressed Level Of (Levomepromazine Consciousness Maleate) C Diarrhoea Dogmatyl (Sulpiride) C Difficulty In Walking Sepazon (Cloxazolam) C Disseminated Fluphenazine C Intravascular Coagulation Haematochezia Multi-Organ Failure Neuroleptic Malignant Syndrome Oedema Pancytopenia Psychotic Disorder Tachycardia 24-Jun-2005 12:19 PM Page: 1574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/01ISR Number: 3828283-7Report Type:Expedited (15-DaCompany Report #US_010974040 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decreased Appetite Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Dehydration Health Risperdal Initial or Prolonged Diabetes Mellitus Professional (Risperidone) C Other Diabetic Coma Company Artane Pharyngitis Representative (Trihexyphenidyl Other Hydrochloride) C Rohypnol (Flunitrazepam) C Halcion (Triazolam) C Date:11/20/01ISR Number: 3828063-2Report Type:Expedited (15-DaCompany Report #US_011076561 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Diabetes Mellitus Health Rohypnol Diabetic Hyperglycaemic Professional (Flunitrazepam) C Coma Company Aricept (Donepezil Erythema Representative Hydrochloride) C Sedation Other Hiberna (Promethazine Hydrochloride) C Daonil (Glibenclamide) C Date:11/20/01ISR Number: 3828064-4Report Type:Expedited (15-DaCompany Report #US_011076460 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Myocardial Infarction Health Vegetamin A C Professional Brotizolam C Company Representative Other Date:11/20/01ISR Number: 3828078-4Report Type:Expedited (15-DaCompany Report #US_011176636 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Blood Creatine Health Lithium C Phosphokinase Increased Professional Valproate Sodium C Blood Lactate Other Clonazepam C Dehydrogenase Increased Chlorpromazine C Condition Aggravated Midazolam C Confusional State Disorientation Hallucination Insomnia 24-Jun-2005 12:19 PM Page: 1575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3828087-5Report Type:Expedited (15-DaCompany Report #US_011176678 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Condition Aggravated Consumer Lorazepam C Platelet Count Decreased Other Amiodarone C White Blood Cell Count Aspirin C Decreased Date:11/20/01ISR Number: 3828098-XReport Type:Expedited (15-DaCompany Report #DE_011107221 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Health Melperone C Professional Other Date:11/20/01ISR Number: 3828099-1Report Type:Expedited (15-DaCompany Report #FR_011000320 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Streptococcal Infection Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Toxic Skin Eruption Health Nozinan Professional (Levomepromazine) C Other Fluanxol (Flupentixol Dihydrochloride) C Date:11/20/01ISR Number: 3828100-5Report Type:Expedited (15-DaCompany Report #FR_011000324 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Coma Health Drug Level Above Professional Therapeutic Other Intentional Misuse Pneumonitis Pyrexia Suicide Attempt Date:11/20/01ISR Number: 3828101-7Report Type:Expedited (15-DaCompany Report #CA_011004465 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Sensation Foreign Zyprexa (Olanzapine) PS 5 MG IN THE Initial or Prolonged Oedema Peripheral Health EVENING Photopsia Professional Bupropion C Weight Increased Other Divalproex Sodium C Lorazepam C Zopiclone C 24-Jun-2005 12:19 PM Page: 1576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3828102-9Report Type:Expedited (15-DaCompany Report #US_011176762 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Decreased Health Dogmatyl (Sulpiride) C Platelet Count Decreased Professional Lodopin (Zotepine) C Red Blood Cell Count Company Haloperidol C Decreased Representative White Blood Cell Count Other Decreased Date:11/20/01ISR Number: 3828124-8Report Type:Expedited (15-DaCompany Report #US_011076547 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Zyprexa (Olanzapine) PS Decreased Health Professional Company Representative Other Date:11/20/01ISR Number: 3828125-XReport Type:Expedited (15-DaCompany Report #US_011076079 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Cardiac Arrest Health Barnetil Condition Aggravated Professional (Sultopride) C Coordination Abnormal Company Serenace Mental Disorder Representative (Haloperidol) C Other Doral (Quazepam) C Hiberna (Promethazine Hydrochloride) C Risperdal (Risperidone) C Pursennid (Senna Leaf) C Date:11/20/01ISR Number: 3828126-1Report Type:Expedited (15-DaCompany Report #FR_011000306 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Pulmonary Embolism Health Gardenal Professional (Phenobarbital) C Other Tegretol (Carbamazepine) C Tercian (Cyamemazine) C Seresta (Oxazepam) C 24-Jun-2005 12:19 PM Page: 1577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3828180-7Report Type:Expedited (15-DaCompany Report #US_000950381 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antiphospholipid Syndrome Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Cold Sweat Paxil (Paroxetine Depression Hydrochloride) C Hypertension Wellbutrin Sr Iron Deficiency (Amfebutamone Menstrual Disorder Hydrochloride) C Nausea Vioxx (Rofecoxib) C Oedema Coumadin (Warfarin Pulmonary Embolism Sodium) C Pulmonary Hypertension Phentermine C Weight Increased Toprol Xl (Metoprolol Succinate) C Lasix (Furosemide) C Niferex (Polysaccharide-Iron Complex) C Date:11/20/01ISR Number: 3828185-6Report Type:Expedited (15-DaCompany Report #US_011176783 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Zyprexa (Olanzapine) PS 7.5 MG/DAY Asthenia Tenormin (Atenolol) C Bone Infection Allopurinol C Circulatory Collapse Procrit Dehydration (Erythropoietin) C Fatigue Amaryl (Glimepiride) C Foot Amputation Ditropan Xl Hip Fracture (Ditropan Xl) C Joint Contracture Aricept (Donepezil Red Blood Cell Count Hydrochloride) C Decreased Multivitamin C Staphylococcal Infection Tremor Urinary Incontinence Urinary Tract Infection Date:11/20/01ISR Number: 3828186-8Report Type:Expedited (15-DaCompany Report #US_011076347 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatotoxicity Health Zyprexa (Olanzapine) PS Professional Clonazepam C Company Representative Date:11/20/01ISR Number: 3828194-7Report Type:Expedited (15-DaCompany Report #US_011076260 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperparathyroidism Health Zyprexa (Olanzapine) PS Oedema Professional 24-Jun-2005 12:19 PM Page: 1578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830777-5Report Type:Periodic Company Report #PHEH2000US10929 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Other Clozaril(Clozapine) Tablet PS ORAL ORAL Risperdal(Risperidon e) SS ORAL 2 MG, QD, ORAL Risperdal Regiment #2 SS ORAL 3 MG, QD, ORAL Risperdal Regiment #3 SS ORAL 2 MG, QD, ORAL Risperdal Regiment #4 SS ORAL 5 MG, QD, ORAL Risperdal Regiment #5 SS ORAL 3 MG, BID, ORAL Zyprexa(Olanzapine) SS ORAL ORAL Benztropine (Benzatropine Mesilate) C Lorazepam C Date:11/20/01ISR Number: 3836011-4Report Type:Periodic Company Report #US_010362879 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Study Olanzapine PS 2.5 MG/ 1 DAY Initial or Prolonged Syndrome Health Zoloft (Sertraline Disability Professional Hydrochloride) C Aricept (Donepezil Hydrochloride) C Calcium C Multivitamin C Ferrous Sulfate C Date:11/21/01ISR Number: 3827925-XReport Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Olanzapine-Zyprexa Hospitalization - Diabetic Ketoacidosis 20mg Eli Lilly PS Eli Lilly ORAL 20MG QHS ORAL Initial or Prolonged Dizziness Paroxetine-Paxil C Polydipsia Polyuria Visual Disturbance Date:11/21/01ISR Number: 3828528-3Report Type:Expedited (15-DaCompany Report #US_011075926 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa (Olanzapine) PS 5 MG Neuroleptic Malignant Professional Haloperidol C Syndrome Company Trazodone C Representative Dantrolene C 24-Jun-2005 12:19 PM Page: 1579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/01ISR Number: 3828640-9Report Type:Expedited (15-DaCompany Report #WAES 01111496 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Literature Tab Midamor Unk PS ORAL PO Health Diazepam Unk SS Professional Olanzapine Unk SS Date:11/21/01ISR Number: 3828907-4Report Type:Expedited (15-DaCompany Report #CA_011004465 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Foreign Zyprexa (Olanzapine) PS 5 MG IN THE Choking Sensation Health MORNING Condition Aggravated Professional Prozac (Fluoxetine Depression Other Hydrochloride) SS 40 MG/2 DAY Dyspnoea Wellbutrin Oedema Peripheral (Amfebutamone Photopsia Hydrochloride) C Psychotic Disorder Epival (Valproate Weight Increased Semisodium) C Lorazepam C Zopiclone C Ultralente Insulin (Insulin Zinc Suspension) C Insulin-Toronto (Insulin Zinc Supension) C Date:11/21/01ISR Number: 3828908-6Report Type:Expedited (15-DaCompany Report #EWC011028689 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Professional Company Representative Other Date:11/21/01ISR Number: 3828909-8Report Type:Expedited (15-DaCompany Report #US_011076547 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Akineton (Biperiden Professional Hydrochloride) C Company Wypax (Lorazepam) C Representative Hirnamin Other (Levomepromazine) C Doral (Quazepam) C Lendormin (Brotizolam) C Pursennid (Senna Leaf) C Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 1580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/01ISR Number: 3828910-4Report Type:Expedited (15-DaCompany Report #FR_011000267 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Leukopenia Health Deroxat (Paroxetine Neutropenia Professional Hydrochloride) C Other Date:11/21/01ISR Number: 3828911-6Report Type:Expedited (15-DaCompany Report #US_011076460 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Vegetamin A C Professional Brotizolam C Company Representative Other Date:11/21/01ISR Number: 3828912-8Report Type:Expedited (15-DaCompany Report #US_011076079 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Cardiac Failure Health Barnetil Coordination Abnormal Professional (Sultopride) C Electrocardiogram Qt Company Serenace Prolonged Representative (Haloperidol) C Electrocardiogram T Wave Other Doral (Quazepam) C Inversion Hiberna Sudden Death (Promethazine Hydrochloride) C Risperdal (Risperidone) C Pursennid (Senna Leaf) C Date:11/21/01ISR Number: 3829088-3Report Type:Expedited (15-DaCompany Report #FR_011100326 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Phosphokinase Increased Health Rivotril Muscle Necrosis Professional (Clonazepam) C Other Tegretol (Carbamazepine) C Tranxene (Clorazepate Dipotassium) C Date:11/21/01ISR Number: 3829089-5Report Type:Expedited (15-DaCompany Report #US_011177022 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Death Myocardial Infarction Foreign Health Professional 24-Jun-2005 12:19 PM Page: 1581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 10 MG/DAY Serenace (Haloperidol) C Artane (Trihexyphenidyl Hydrochloride) C Rohypnol (Flunitrazepam) C Coolspan (Sulpiride) C Risperidone C Isosorbide Dinitrate C Tagamet (Cimetidine) C Herbesser (Diltiazem Hydrochloride) C Miorelark (Eperisone Hydrochloride) C Etilefrine Hydrochloride C Allopurinol C Bezatol - Slow Release (Bezafibrate) C Date:11/21/01ISR Number: 3829156-6Report Type:Expedited (15-DaCompany Report #EWC011128920 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Foreign Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Health Clopixol Professional (Zuclopenthixol Other Decanoate) C Tavor (Lorazepam) C Date:11/21/01ISR Number: 3829157-8Report Type:Expedited (15-DaCompany Report #US_011075387 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa (Olanzapine) PS 280 MG/DAY Initial or Prolonged Rhabdomyolysis Health Seroquel C Professional Halciol (Triazolam) C Company Rohypnol Representative (Flunitrazepam) C Other Wypax (Lorazepam) C Pursennid (Senna Leaf) C Ubretid (Distigmine Bromide) C Date:11/21/01ISR Number: 3829158-XReport Type:Expedited (15-DaCompany Report #EWC011128881 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Death Completed Suicide Foreign Health Professional 24-Jun-2005 12:19 PM Page: 1582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Olanzapine PS 5 MG DAY Risperidone C Valproate Semisodium C Date:11/21/01ISR Number: 3829159-1Report Type:Expedited (15-DaCompany Report #EWC010526709 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa (Olanzapine) PS 10 MG DAY 1 MON Initial or Prolonged Exposure To Therapeutic Health Cisordinol Drugs Professional (Clopenthixol Premature Baby Company Hydrochloride) C Representative Disipal Other (Orphenadrine Hydrochloride) C Date:11/21/01ISR Number: 3829164-5Report Type:Expedited (15-DaCompany Report #DE_011107208 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa (Olanzapine) PS 5 MG DAY Initial or Prolonged Posture Abnormal Health Thombran (Trazodone Professional Hydrochloride) C Other Aricept (Donepezil Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Ass C Date:11/21/01ISR Number: 3829167-0Report Type:Expedited (15-DaCompany Report #DE_011107207 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG DAY Life-Threatening Health Professional Other Date:11/21/01ISR Number: 3829171-2Report Type:Expedited (15-DaCompany Report #DE_011107202 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Foreign Zyprexa (Olanzapine) PS 2.5 MG 1 DAY Initial or Prolonged Deficit/Hyperactivity Health Trevilor Disorder Professional (Venlafaxine Dyskinesia Other Hydrochloride) C Eunerpan (Melperone Hydrochloride) C Remergil (Mirtazapine) C Beloc Zok (Metoprolol Succinate) C 24-Jun-2005 12:19 PM Page: 1583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Duspatal (Mebeverine) C Antra (Omeprazole) C Date:11/21/01ISR Number: 3829175-XReport Type:Expedited (15-DaCompany Report #GBS011109692 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myeloid Leukaemia Foreign Zyprexa Hospitalization - Overdose Health (Olanzapine) PS 30 MG DAY Initial or Prolonged Pneumonia Professional Fluoxetine C Other Modecate (Fluphenazine Decanoate) C Diazepam C Depo Provera (Medroxyprogesterone Acetate) C Date:11/21/01ISR Number: 3829305-XReport Type:Expedited (15-DaCompany Report #US_011176945 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 1500 MG/DAY Initial or Prolonged Intentional Misuse Professional Xanax (Alprazolam) C Pneumonia Aspiration Rhabdomyolysis Date:11/21/01ISR Number: 3829328-0Report Type:Expedited (15-DaCompany Report #US_011177146 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/21/01ISR Number: 3829332-2Report Type:Expedited (15-DaCompany Report #US_011176835 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Road Traffic Accident Consumer Zyprexa (Olanzapine) PS 10 DAY Sleep Attacks Date:11/21/01ISR Number: 3829421-2Report Type:Expedited (15-DaCompany Report #US_011176909 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Humalog-. (Lispro) PS Initial or Prolonged Congestive Zyprexa (Olanzapine) SS 5 MG/1 DAY Other Prozac (Fluoxetine Hydrochloride) SS 60MG/DAY Lasix (Furosemide) C Atenolol C Imdur (Isosorbide Mononitrate) C 24-Jun-2005 12:19 PM Page: 1584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Estrace (Estradiol) C Prevacid (Lansoprazole) C K-Dur (Potassium Chloride) C Zocor (Simvastatin) C Norvasc (Amlodipine Besilate) C Avandia (Rosglitazone Maleate) C Date:11/21/01ISR Number: 3829463-7Report Type:Expedited (15-DaCompany Report #WAES 01111497 Age:65 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Tab Prinivil PS ORAL PO Health Olanzapine Unk SS Professional Mirtazapine Unk SS Date:11/21/01ISR Number: 3829669-7Report Type:Expedited (15-DaCompany Report #US_011076268 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Corrected Interval Health Haloperidol Prolonged Professional Decanoate C Company Serenace Representative (Haloperidol) C Other Akineton (Biperiden Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Silece (Flunitrazepam) C Amoran (Zopiclone) C Levotomin (Levomepromazine Maleate) C Hiberna (Promethazine Hydrochloride) C Selbex (Teprenone) C Magnesium Oxide C Date:11/21/01ISR Number: 3829766-6Report Type:Expedited (15-DaCompany Report #US_011074942 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Zyprexa (Olanzapine) PS 10 MG/DAY Grand Mal Convulsion Professional Risperdal Laceration (Risperidone) C Subdural Haematoma Depakote (Valproate Semisodium) C Clonazepam C Benadryl (Diphenhydramine 24-Jun-2005 12:19 PM Page: 1585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Ibuprofen C Date:11/21/01ISR Number: 3829771-XReport Type:Expedited (15-DaCompany Report #US_010770382 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Difficulty In Walking Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Sedation Date:11/21/01ISR Number: 3830083-9Report Type:Expedited (15-DaCompany Report #US_011076251 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Prolonged Health Lendormin Pyrexia Professional (Brotizolam) C Company Amlodin (Amlodipine Representative Besilate) C Other Lasix (Furosemide) C Myonal (Eperisone Hydrochloride) C Foipan (Camostate Mesilate) C Aspara K (Aspartate Potassium) C Nitrol (Glyceryl Trinitrate) C Date:11/21/01ISR Number: 3830088-8Report Type:Expedited (15-DaCompany Report #DE_011107201 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Life-Threatening Health Prednisolon C Professional Zoloft (Sertraline Other Hydrochloride) C Stangyl (Trimipramine Maleate) C Edronax (Reboxetine) C Kreon (Pancreatin) C Antra (Omeprazole) C Date:11/21/01ISR Number: 3830090-6Report Type:Expedited (15-DaCompany Report #US_011177211 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rhabdomyolysis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Health Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 1586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/01ISR Number: 3830092-XReport Type:Expedited (15-DaCompany Report #EWC011128941 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Foreign Zyprexa (Olanzapine) PS Muscle Spasms Health Zoloft (Sertraline Professional Hydrochloride) C Other Beserol C Date:11/21/01ISR Number: 3830118-3Report Type:Expedited (15-DaCompany Report #DE_011107304 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa (Olanzapine) PS Health Professional Other Date:11/26/01ISR Number: 3828606-9Report Type:Expedited (15-DaCompany Report #301831 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Klonopin PS Roche Initial or Prolonged Mood Swings Zyban I Tobacco Abuse Topamax I Zyprexa I Geodon I Divalproex I Date:11/27/01ISR Number: 3830517-XReport Type:Expedited (15-DaCompany Report #US_011177666 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa-Oral Exposure To Therapeutic Professional (Olanzapine) Drugs (Olanzapine) PS Premature Baby Xanax C Respiratory Distress Date:11/27/01ISR Number: 3830518-1Report Type:Expedited (15-DaCompany Report #US_011177467 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Health Zyprexa (Olanzapine) PS 400 MG/DAY Initial or Prolonged Feeling Drunk Professional Lithium C Heart Rate Increased Clonazepam C Hypothyroidism Celexa(Citalopram Overdose Hydrobromide) C Ambien (Zolpidem Tartrate) C Date:11/27/01ISR Number: 3830996-8Report Type:Expedited (15-DaCompany Report #US_010973640 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Death Completed Suicide Health Professional 24-Jun-2005 12:19 PM Page: 1587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 15 MG DAY Haldol (Haloperidol) C Date:11/27/01ISR Number: 3831183-XReport Type:Expedited (15-DaCompany Report #EWC011129004 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Calmaxid Initial or Prolonged Hepatic Infarction Health (Nizatidine) PS 450 MG/DAY Weight Increased Professional Zyprexa (Olanzapine) SS 20 MG/DAY Other Ludiomil (Maprotiline Hydrochloride) C Quilonorm (Lithium Acetate) C Date:11/27/01ISR Number: 3831380-3Report Type:Expedited (15-DaCompany Report #US_011176762 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Increased Health Dogmatyl (Sulpiride) C Aspartate Professional Lodopin (Zotepine) C Aminotransferase Company Linton (Haloperidol) C Increased Representative Tasmolin (Biperiden) C Haematocrit Decreased Other Hiberna Haemoglobin Decreased (Promethazine Platelet Count Decreased Hydrochloride) C Red Blood Cell Count Penselin Decreased (Dipyridamole) C White Blood Cell Count Silece Decreased (Flunitrazepam) C Tinelac (Sennoside A+B) C Date:11/27/01ISR Number: 3831456-0Report Type:Expedited (15-DaCompany Report #US_011075722 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Other Complete Health Haloperidol C Bradycardia Professional Tolopelon Bundle Branch Block Left Company (Timiperone) C Bundle Branch Block Right Representative Risperidone C Cardiac Disorder Other Levotomin(Levomeprom Condition Aggravated azine Maleate) C Coronary Artery Disease Depakene (Valproate Dystonia Sodium) C Respiratory Arrest Tasmolin (Biperiden) C Speech Disorder Developmental 24-Jun-2005 12:19 PM Page: 1588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/01ISR Number: 3831566-8Report Type:Expedited (15-DaCompany Report #EWC011129042 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Other Accuprin (Quinapril Increased Hydrochloride) C Blood Alkaline Aspirinetta Phosphatase Increased (Acetylsalicylic Blood Bilirubin Increased Acid) C Gamma-Glutamyltransferase Bi-Euglucon M C Increased Jaundice Date:11/27/01ISR Number: 3831572-3Report Type:Expedited (15-DaCompany Report #EWC011129025 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Foreign Olanzapine PS 70 DSG FORM Hospitalization - Loss Of Consciousness Health Initial or Prolonged Neuroleptic Malignant Professional Syndrome Other Overdose Pyrexia Restlessness Suicide Attempt Tachycardia Date:11/27/01ISR Number: 3831574-7Report Type:Expedited (15-DaCompany Report #EWC011128968 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Olanzapine PS 10 DAY Carpal Tunnel Syndrome Health Methadone C Oedema Peripheral Professional Rivotril Red Blood Cell Other (Clonazepam) C Sedimentation Rate Seresta (Oxazepam) C Increased Dalmadorm (Flurazepam Hydrochloride) C Deroxat (Paroxetine Hydrochloride) C Date:11/27/01ISR Number: 3831576-0Report Type:Expedited (15-DaCompany Report #DE_011107311 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatitis Foreign Zyprexa (Olanzapine) PS Drug Toxicity Health Diazepam C Inflammation Professional Amitriptyline C Lung Disorder Other Respiratory Disorder Suicide Attempt Thyroid Disorder Urinary Retention 24-Jun-2005 12:19 PM Page: 1589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/01ISR Number: 3831577-2Report Type:Expedited (15-DaCompany Report #DE_011107314 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Thrombocytopenia Health Spasmex (Trospium White Blood Cell Disorder Professional Chloride) C Other Date:11/27/01ISR Number: 3831591-7Report Type:Expedited (15-DaCompany Report #EWC011028675 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa Initial or Prolonged Cerebrovascular Accident Health (Olanzapine) PS 10 MG/1 DAY Decreased Activity Professional Tegretol Depressed Level Of (Carbazepine) C Consciousness Rohypnol Facial Palsy (Flunitrazepam) C Haemoglobin Decreased Haemorrhagic Stroke Headache Hemiparesis Hemiplegia Hypoaesthesia Sedation Speech Disorder Date:11/27/01ISR Number: 3831593-0Report Type:Expedited (15-DaCompany Report #EWC011028803 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Foreign Zyprexa (Olanzapine) PS Bone Marrow Depression Health Zoloft (Sertraline Haemoglobin Decreased Professional Hydrochloride) C Weight Decreased Other Propavan White Blood Cell Count (Propiomazine Decreased Maleate) C Stilnoct (Zolpidem) C Stesolid (Diazepam) C Flagyl (Metronidazole) C Kavepenin (Phenoxymethylpenici llin Potassium) C Date:11/27/01ISR Number: 3831683-2Report Type:Expedited (15-DaCompany Report #EWC010727598 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Olanzapine PS 10 MG/DAY Condition Aggravated Health Temesta (Lorazepam) C Leukopenia Professional Loramet Other (Lormetazepam) C Zantac (Ranitidine Hydrochloride) C Xanax - Slow Release (Alprazolam) C Serenase 24-Jun-2005 12:19 PM Page: 1590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Haloperidol) C Cipramil (Citalopram Hydrobromide) C Sotalex (Sotalol Hydrochloride) C Asaflow (Acetylsalicylic Acid) C Effortil Pl (Etileprine Hydrochloride) C Date:11/28/01ISR Number: 3831358-XReport Type:Expedited (15-DaCompany Report #301831 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Klonopin Initial or Prolonged Drug Interaction Other (Clonazepam) PS Mood Swings Zyban (Bupropion Tobacco Abuse Hydrochloride) SS ORAL ORAL Topamax (Topiramate) SS Zyprexa (Olanzapine) SS Geodon (Ziprasidone Hydrochloride) SS Divalproex (Divalproex Sodium) SS Date:11/28/01ISR Number: 3831812-0Report Type:Expedited (15-DaCompany Report #NSADSS2001034911 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mood Swings Consumer Topamax Initial or Prolonged Suicidal Ideation (Unspecified) (Topiramate) PS Zyban (Amfebutamone Hydrochloride) SS ORAL Olanzapine (Olanzapine) SS Clonazepam (Clonazepam) SS Date:11/29/01ISR Number: 3832124-1Report Type:Expedited (15-DaCompany Report #PHRM2001FR02581 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Tegretol Lp PS ORAL 200 MG, BID, Initial or Prolonged Drug Level Above Health ORAL Therapeutic Professional Tegretol(Carbazmazep Epilepsy Other ine) Suspension SS ORAL 100 MG, QD, Overdose ORAL Pneumonia Aspiration Zyprexa (Olanzapine) Psychotic Disorder Tablet SS ORAL 1 DF, QD, Sedation ORAL 24-Jun-2005 12:19 PM Page: 1591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832831-0Report Type:Periodic Company Report #US_010870991 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Zyprexa Overdose (Olanzapine) PS 30 MG/DAY Weight Increased Zoloft (Sertaline Hydrochloride) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3832832-2Report Type:Periodic Company Report #US_010871045 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Study Zyprexa (Olanzapine) PS 20 MG DAY Hospitalization - Health Initial or Prolonged Professional Date:11/29/01ISR Number: 3832833-4Report Type:Periodic Company Report #US_010871143 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Consumer Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Haldol (Haloperidol) C Seroquel C Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3832834-6Report Type:Periodic Company Report #US_010871148 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Miosis Health Zyprexa (Olanzapine) PS Initial or Prolonged Schizophrenia Professional Date:11/29/01ISR Number: 3832835-8Report Type:Periodic Company Report #US_010870751 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa (Olanzapine) PS Initial or Prolonged Sedation Professional Company Representative Date:11/29/01ISR Number: 3832836-XReport Type:Periodic Company Report #US_010870770 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG IN THE Initial or Prolonged Health EVNING Professional Fluoxetine (Gluoxetine Hydrochloride) SS 25 MG IN THE 24-Jun-2005 12:19 PM Page: 1592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report EVENING Estrogen Nos C Pravachol (Pravastatin Sodium) C Synthroid (Levothyroxine Sodium) C Date:11/29/01ISR Number: 3832837-1Report Type:Periodic Company Report #US_010870797 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mydriasis Health Zyprexa (Olanzapine) PS 205 MG/DAY Initial or Prolonged Overdose Professional Somnolence Company Representative Date:11/29/01ISR Number: 3832838-3Report Type:Periodic Company Report #US_010770351 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Prescribed Overdose Professional Clozapine C Other Depakote (Valproate Semisodium) C Lorazepam C Date:11/29/01ISR Number: 3832839-5Report Type:Periodic Company Report #US_010770368 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Prilosec Professional (Omeprazole) C Pepcid (Famotidine) C Lithium C Alupent (Orciprenaline Sulfate) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3832840-1Report Type:Periodic Company Report #US_010770460 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 1 WK Initial or Prolonged Professional Neurontin Company (Gabapentin) C Representative Xanax C Paxil (Paroxetine Hydrochloride) C Estradiol C Pepcid (Famotidine) C Soma (Carisoprodol) C Albuterol C Serevent (Salmeterol Xinafoate) C Lasix (Furosemide) C 24-Jun-2005 12:19 PM Page: 1593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lortab C Beclovent Inhaler ( Beclometasone Dipropionate) C Catapressan Tts (Clonidine Hydrochloride) C Stadol (Butorphanol Tartrate) C Date:11/29/01ISR Number: 3832841-3Report Type:Periodic Company Report #US_001256055 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Zyprexa PS 10 MG/1 DAY Tardive Dyskinesia Professional Lithium C Tegretol (Carbamazepine) C Seroquel C Lotensin (Benazepril Hydrochloride) C Cardizem Cd (Diltiazem Hydrochloride) C Estrogen W/Medroxyprogesteron C Date:11/29/01ISR Number: 3832842-5Report Type:Periodic Company Report #US_010156744 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Health Zyprexa PS 20 MG/DAY Initial or Prolonged Loss Of Consciousness Professional Quetiapine C Sedation Company Thorazine Representative (Chlorpromazine Hydrochloride) C Luvox (Fluvoxamine Maleate) C Tegretol (Carbamazepine) C Oral Hypoglycemic C Date:11/29/01ISR Number: 3832843-7Report Type:Periodic Company Report #US_001255876 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Study Olanzapine PS 1 DSG FORM/ Health DAY Professional Propranolol Hcl W/ Other Hydrochlorothiazide C Lorazepam C 24-Jun-2005 12:19 PM Page: 1594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832844-9Report Type:Periodic Company Report #US_001255724 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sinusitis Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Protonix C Avandia (Rosiglitazone Maleate) C Kcl-Retard (Potassium Chloride) C Lasix (Furosemide) C Singulair (Montelukast Sodium) C Date:11/29/01ISR Number: 3832845-0Report Type:Periodic Company Report #US_001255736 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 2 DSG FORM/ Initial or Prolonged Confusional State Health AT BEDTIME Other Delirium Professional Aricept (Donepezil Hostility Hydrochloride) C Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Hydrodiuril (Hydrochlorothiazide ) C Prempro C Nitroglycerin (Glyceryl Trinitrate) C Bactrim Ds C Date:11/29/01ISR Number: 3832846-2Report Type:Periodic Company Report #US_001255762 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Zyprexa PS 5 MG/DAY Initial or Prolonged Hip Fracture Health Aricept (Donepezil Disability Hypernatraemia Professional Hydrochloride) C Leukocytosis Aspirin C Renal Failure Acute Digoxin C Vasotec (Enalapril Maleate) C Flomax (Morniflumate) C Folic Acid C Metoprolol C Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832847-4Report Type:Periodic Company Report #US_001254939 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia, Paranoid Study Olanzapine PS Initial or Prolonged Type Health Professional Date:11/29/01ISR Number: 3832848-6Report Type:Periodic Company Report #US_001254940 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia, Paranoid Study Olanzapine PS Initial or Prolonged Type Health Professional Date:11/29/01ISR Number: 3832849-8Report Type:Periodic Company Report #US_001254947 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia, Paranoid Study Olanzapine PS Initial or Prolonged Type Health ... C Professional ... C Date:11/29/01ISR Number: 3832850-4Report Type:Periodic Company Report #US_001254995 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Study Olanzapine PS 7.5 MG/DAY Hospitalization - Carcinoma Health Paxil (Paroxetine Initial or Prolonged Professional Hydrochloride) C Benzatropine C Date:11/29/01ISR Number: 3832851-6Report Type:Periodic Company Report #US_001255008 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Study Olanzapine PS 1 DSG Initial or Prolonged Health FORM/DAY Professional Placebo SS 1 DSG FORM/DAY Date:11/29/01ISR Number: 3832852-8Report Type:Periodic Company Report #US_001255017 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Homicidal Ideation Study Olanzapine PS 15 MG/AT Initial or Prolonged Health BEDTIME Professional Olanzapine SS 20 MG/1 AT BEDTIME Aspirin C Carbamazepine C Lovastatin C Propoxyphene C Ranitidine C Sertraline C 24-Jun-2005 12:19 PM Page: 1596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832853-XReport Type:Periodic Company Report #US_001255036 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Phosphokinase Increased Professional Muscle Rigidity Company Neuroleptic Malignant Representative Syndrome Sluggishness Urinary Retention Date:11/29/01ISR Number: 3832854-1Report Type:Periodic Company Report #US_001255258 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Eating Disorder Professional Inhalers C Headache Ace-Inhibitor C Hyponatraemia Date:11/29/01ISR Number: 3832855-3Report Type:Periodic Company Report #US_001255315 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Polydipsia Health Zyprexa (Olanzapine) PS 5 MG/ 1 DAY Initial or Prolonged Professional Company Representative Date:11/29/01ISR Number: 3832856-5Report Type:Periodic Company Report #US_001255338 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Study Olanzapine PS 2 DSG Initial or Prolonged Health FORM/DAY Professional Date:11/29/01ISR Number: 3832857-7Report Type:Periodic Company Report #US_001255433 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Study Olanzapine PS 20 MG/DAY Hospitalization - Health Ativan (Lorazepam) C Initial or Prolonged Professional Date:11/29/01ISR Number: 3832858-9Report Type:Periodic Company Report #US_001255486 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Zyprexa (Olanzapine) PS Professional Benzthopine C Other Lorazepam C 24-Jun-2005 12:19 PM Page: 1597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832859-0Report Type:Periodic Company Report #US_001255488 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS 630 MG/DAY Initial or Prolonged Loss Of Consciousness Professional Celexa (Citalopram Hydrobromide) C Date:11/29/01ISR Number: 3832860-7Report Type:Periodic Company Report #US_001254805 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3832861-9Report Type:Periodic Company Report #US_001254810 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3832862-0Report Type:Periodic Company Report #US_001254815 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3832863-2Report Type:Periodic Company Report #US_001254782 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa (Olanzapine) PS 22.5 MG/DAY Congestive Professional Overdose Company Pitting Oedema Representative Date:11/29/01ISR Number: 3832864-4Report Type:Periodic Company Report #US_001254686 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Professional Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832865-6Report Type:Periodic Company Report #US_001254727 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3832866-8Report Type:Periodic Company Report #US_001254750 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia, Paranoid Study Olanzapine PS Initial or Prolonged Type Health Professional Date:11/29/01ISR Number: 3832867-XReport Type:Periodic Company Report #US_001254762 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3832868-1Report Type:Periodic Company Report #US_001254768 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3832869-3Report Type:Periodic Company Report #US_001254602 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Ileus Paralytic Professional Haldol (Haloperidol) C Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Trazodone C Cogentin (Benzatropien Mesilate) C Date:11/29/01ISR Number: 3832870-XReport Type:Periodic Company Report #US_001153967 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Self-Injury Study Olanzapine PS 1 MG/1 DAY Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 5 MG/ 1 DAY Asa (Acetylsalicylic Acid) C 24-Jun-2005 12:19 PM Page: 1599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan (Lorazepam) C Glyburide C Glucophage (Metformin Hydrochloride) C Accupril (Quinapril Hydrochloride) C Indocin (Indometacin) C Date:11/29/01ISR Number: 3832871-1Report Type:Periodic Company Report #US_001154082 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS Syndrome Professional Company Representative Date:11/29/01ISR Number: 3832872-3Report Type:Periodic Company Report #US_001154165 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 20 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Etodolac C Hydroxyzine Pamoate C Terbinafine C Clonazepam C Date:11/29/01ISR Number: 3832873-5Report Type:Periodic Company Report #US_001153698 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3832874-7Report Type:Periodic Company Report #US_001153799 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Consumer Zyprexa (Olanzapine) PS 20 MG/DAY 2 YR Health Professional Date:11/29/01ISR Number: 3832875-9Report Type:Periodic Company Report #US_001153873 Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Akathisia Initial or Prolonged Anxiety Asthenia Depression Dyskinesia 24-Jun-2005 12:19 PM Page: 1600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Navane (Tiotixene) C Company Paxil (Paroxetine Representative Hydrochloride) C Verapamil C Synthroid (Levothyroxine Sodium) C Premarin (Estrogens Conjugated) C Trazodone C Date:11/29/01ISR Number: 3832876-0Report Type:Periodic Company Report #US_001153386 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Olanzapine PS 12 MG/ 1 DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 75 MG/ 1 DAY Date:11/29/01ISR Number: 3832877-2Report Type:Periodic Company Report #US_001153547 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prostate Cancer Study Olanzapine PS 5 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Sertraline C Docusate C Aspirin C Psyllium C Albuterol C Ibuprofen C Nortriptyline C Ipratropium C Date:11/29/01ISR Number: 3832878-4Report Type:Periodic Company Report #US_010871753 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Progression Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Weight Increased Date:11/29/01ISR Number: 3832879-6Report Type:Periodic Company Report #US_010871600 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Olanzapine PS 10 MG DAY Initial or Prolonged Health Placebo SS 2 DSG FORM Professional DAY Detrol (Tolterodine L-Tartrate) C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 1601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan (Lorazepam) C Ferrous Sulfate C Date:11/29/01ISR Number: 3832880-2Report Type:Periodic Company Report #US_010871551 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa (Olanzapine) PS 15 MAG/DAY Initial or Prolonged Ketoacidosis Professional Clonidine C Company Neurontin Representative (Gabapentin) C Cogentin (Benzatropine Mesilate) C Thorazine (Chlorpromazine Hydrochloride) C Topamax (Topiramate) C Atenolol C Date:11/29/01ISR Number: 3832881-4Report Type:Periodic Company Report #US_010871390 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Professional Imdur - Slow Release(Isosorbide Mononitrate) C Vasotec (Enalapril Maleate) C Cardizem (Diltiazem Hydrochloride) C Micronase (Glibenclamide) C Pepcid (Famotidine) C Detrol (Tolterodine L-Tartrate) C Catapres (Clonidine) C Ferrous Sulfate C Date:11/29/01ISR Number: 3832882-6Report Type:Periodic Company Report #US_010871446 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Professional Premarin (Estrogens Conjugated) C Date:11/29/01ISR Number: 3832883-8Report Type:Periodic Company Report #US_010871493 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ectopic Pregnancy Study Olanzapine PS 10 MG/2 DAY Initial or Prolonged Health Vicodin C Professional 24-Jun-2005 12:19 PM Page: 1602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832884-XReport Type:Periodic Company Report #US_010871269 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Study Olanzapine PS 6 MG DAY Initial or Prolonged Interstitial Lung Disease Health Fluoxetine(Fluoxetin Pneumonia Professional e Hydrochloride) SS 25 MG DAY Atenolol C Lipitor (Atorvastatin) C Prempro C Zyrtec (Cetirizine Hydrochloride) C Flonase (Fluticasone Propionate) C Soma(Carisoprodol) C Date:11/29/01ISR Number: 3832885-1Report Type:Periodic Company Report #US_010871205 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Study Olanzapine PS 15 MG DAY Initial or Prolonged Health Amantadine SS 3 DSG FORM Professional DAY Zoloft (Sertraline Hydrochloride) C Lithium C Date:11/29/01ISR Number: 3832886-3Report Type:Periodic Company Report #US_010871215 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecal Incontinence Study Olanzapine PS 5 MG DAY Initial or Prolonged Health Multivitamin C Disability Professional Ginkgo Biloba C Vitamin E C Glyburide C Flomax (Morniflumate) C Aricept (Donepezil Hydrochloride) C Aspirin C Celexa (Citalopram Hydrobromide) C Ativan(Lorazepam) C Date:11/29/01ISR Number: 3832887-5Report Type:Periodic Company Report #US_010871245 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 20 MG/DAY Initial or Prolonged Health Benzatropine Professional Mesilate C Analgesic Balm C Methocarbamol C Terbinafine C Divalproex Sodium C Ibuprofen C Ranitidine C 24-Jun-2005 12:19 PM Page: 1603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anusol-Hc C Dibucaine C Amoxicillin C Clarithromycin C Hydrocortisone C Lansoprazole C Date:11/29/01ISR Number: 3832888-7Report Type:Periodic Company Report #US_010870919 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Prozac (Fluoxetine Nervous System Disorder Hydrochloride) PS 10 MG/DAY Zyprexa (Olanzapine) SS 5 MG/DAY Ativan(Lorazepam) C Norvasc(Amlodipine Besilate) C Lozol (Indapamide) C Date:11/29/01ISR Number: 3832889-9Report Type:Periodic Company Report #US_010870921 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Health Placebo SS Professional Ativan(Lorazepam) C Date:11/29/01ISR Number: 3832890-5Report Type:Periodic Company Report #US_010870985 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Health Zyprexa-Oral Jaundice Professional (Olanzapine) Liver Function Test Company (Olanzapine) PS 5 MG/DAY Abnormal Representative Aspirin C Weight Decreased Date:11/29/01ISR Number: 3832891-7Report Type:Periodic Company Report #US_010770560 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Tegretol Professional (Carbamazepine) C Celexa (Citalopram Hydrobromide) C Topamax (Topiramate) C Acetaminophen C Date:11/29/01ISR Number: 3832892-9Report Type:Periodic Company Report #US_010770288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Intentional Misuse Suicide Attempt 24-Jun-2005 12:19 PM Page: 1604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832893-0Report Type:Periodic Company Report #US_010770231 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3832894-2Report Type:Periodic Company Report #US_010770113 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Study Zyprexa (Olanzapine) PS 15 MG/DAY Consumer Ritalin Health (Methylphenidate Professional Hydrochloride) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:11/29/01ISR Number: 3832895-4Report Type:Periodic Company Report #US_010770127 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Study Olanzapine PS 10 MG/AT Initial or Prolonged Health BEDTIME Professional Placebo SS 10 MG/DAY Ibuprofen C Prozac (Fluoxetine Hydrochloride) C Indocin (Indometacin) C Trazodone C Zyprexa (Olanzapine) C Date:11/29/01ISR Number: 3832896-6Report Type:Periodic Company Report #US_010770150 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5 MG/1 AT Initial or Prolonged Suicidal Ideation Health BEDTIME Professional Estrogen Nos C Date:11/29/01ISR Number: 3832897-8Report Type:Periodic Company Report #US_010769959 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Impaired Healing Study Olanzapine PS 6 MG/1 IN THE Initial or Prolonged Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 IN THE EVENING Hydrochlorothiazide C 24-Jun-2005 12:19 PM Page: 1605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832898-XReport Type:Periodic Company Report #US_010770065 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petit Mal Epilepsy Consumer Zyprexa (Olanzapine) PS 5 MG/ 1 DAY 42 MON Prozac (Fluoxetine Hydrochloride) SS 20 MG/ 2 DAY 4 YR Baclofen C Dilantin (Phenytoin Sodium) C Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3832899-1Report Type:Periodic Company Report #US_010769900 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 6 MG DAY Initial or Prolonged Depression Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG DAY Lorazepam C Date:11/29/01ISR Number: 3832900-5Report Type:Periodic Company Report #US_010769887 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG IN THE Initial or Prolonged Suicidal Ideation Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG IN THE EVENING Ativan (Lorazepam) C Ramipril C Prempro C Date:11/29/01ISR Number: 3834124-4Report Type:Periodic Company Report #US_010768854 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Study Olanzapine PS 4 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 4 DSG FORM/1 AT BEDTIME Asmacort (Triamcinolone Acetonide) C Librium (Chlordiazepoxide Hydrochloride) C Date:11/29/01ISR Number: 3834125-6Report Type:Periodic Company Report #US_010768797 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Blood Glucose Increased Health Initial or Prolonged Diabetic Ketoacidosis Professional 24-Jun-2005 12:19 PM Page: 1606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 20 MG/1 DAY Date:11/29/01ISR Number: 3834126-8Report Type:Periodic Company Report #US_010768800 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Professional Company Representative Date:11/29/01ISR Number: 3834127-XReport Type:Periodic Company Report #US_010768839 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Olanzapine PS 6 DSG Initial or Prolonged Professional FORM/DAY Date:11/29/01ISR Number: 3834128-1Report Type:Periodic Company Report #US_010668582 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa (Olanzapine) PS 15 MG/DAY Professional Date:11/29/01ISR Number: 3834129-3Report Type:Periodic Company Report #US_010768639 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3834130-XReport Type:Periodic Company Report #US_010768695 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 1 DSG FORM/AT Initial or Prolonged Dyspnoea Health BEDTIME Professional Fluoxetine(Fluoxetin e Hydrochloride) SS 1 DSG FORM/AT BEDTIME Prinzide C Atenolol C Asa (Acetylsalicylic Acid) C Multivitamin C Niacin C Excedrin Migraine C 24-Jun-2005 12:19 PM Page: 1607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3834131-1Report Type:Periodic Company Report #US_010668217 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Diabetes Mellitus Other Dry Mouth Gait Disturbance Increased Appetite Malaise Nasopharyngitis Weight Increased Date:11/29/01ISR Number: 3834132-3Report Type:Periodic Company Report #US_010668227 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Consumer Zyprexa (Olanzapine) PS Loss Of Consciousness Health Lithium C Memory Impairment Professional Nausea Vomiting Weight Decreased Date:11/29/01ISR Number: 3834133-5Report Type:Periodic Company Report #US_010668233 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Study Zyprexa (Olanzapine) PS 10 MG DAY Initial or Prolonged Health Labetalol C Disability Professional Dorzolamide C Multivitamin C Vitamin E C Metamucil (Psyllium Hydrophilic Mucilloid) C Aspirin C Date:11/29/01ISR Number: 3834134-7Report Type:Periodic Company Report #US_010668260 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Consumer Zyprexa (Olanzapine) PS 20 MG/ 1 DAY Initial or Prolonged Schizophrenia Weight Increased Date:11/29/01ISR Number: 3834135-9Report Type:Periodic Company Report #US_010668314 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Zyprexa (Olanzapine) PS Hypotension Professional Luvox (Fluvoxamine Intentional Misuse Maleate) C 24-Jun-2005 12:19 PM Page: 1608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3834136-0Report Type:Periodic Company Report #US_010668320 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Consumer Zyprexa (Olanzapine) PS 70 MG/ DAY Initial or Prolonged Heart Rate Decreased Company Lithium C Insomnia Representative Intentional Misuse Somnolence Tremor Date:11/29/01ISR Number: 3834137-2Report Type:Periodic Company Report #US_010668389 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5 MG/DAY Initial or Prolonged Health Ativan (Lorazepam) C Professional Date:11/29/01ISR Number: 3834138-4Report Type:Periodic Company Report #US_010667945 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Misuse Study Olanzapine PS 15 MG/ AT Hospitalization - Suicide Attempt Health BEDTIME Initial or Prolonged Professional Ambien (Zolpidem Tartrate) C Lithium C Date:11/29/01ISR Number: 3834139-6Report Type:Periodic Company Report #US_010668028 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia, Paranoid Study Olanzapine PS 10 MG/ 2 DAY Initial or Prolonged Type Health Prozac (Fluoxetine Professional Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3834140-2Report Type:Periodic Company Report #US_010668035 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 20 MG AT Initial or Prolonged Health BEDTIME Professional Lorazepam C Benzotropine (Benzatropine Mesilate) C Date:11/29/01ISR Number: 3834141-4Report Type:Periodic Company Report #US_010668040 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS 30 MG DAY Initial or Prolonged Health Neurontin Professional (Gabapentin) C 24-Jun-2005 12:19 PM Page: 1609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Benadryl (Diphenhydramine Hydrochloride) C Date:11/29/01ISR Number: 3834142-6Report Type:Periodic Company Report #US_010668045 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3834143-8Report Type:Periodic Company Report #US_010668047 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS 6 MG AT Initial or Prolonged Health BEDTIME Professional Doxepin C Date:11/29/01ISR Number: 3834144-XReport Type:Periodic Company Report #US_010668060 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 6 MG/DAY Initial or Prolonged Mania Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 20 MG/DAY Date:11/29/01ISR Number: 3834145-1Report Type:Periodic Company Report #US_010668078 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa Professional (Olanzapine) PS 20 MG/1 DAY Company Prozac (Fluoxetine Representative Hydrochloride) SS 20 MG/DAY Neurontin (Gabapentin) C Klonopin (Clonazepam) C Date:11/29/01ISR Number: 3834146-3Report Type:Periodic Company Report #US_010668112 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 17 MG/DAY Initial or Prolonged Health Depakote (Valproate Professional Semisodium) C Other Lithium C 24-Jun-2005 12:19 PM Page: 1610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3834147-5Report Type:Periodic Company Report #US_010668118 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Depakote (Valproate Professional Semisodium) C Other Date:11/29/01ISR Number: 3834148-7Report Type:Periodic Company Report #US_010668121 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Consumer Zyprexia Initial or Prolonged Schizophrenia (Olanzapine) PS 20 MG/DAY 5 YR Date:11/29/01ISR Number: 3834149-9Report Type:Periodic Company Report #US_010668123 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS 20 MG/AT Initial or Prolonged Health BEDTIME Professional Depakote (Valproate Other Semisodium) C Date:11/29/01ISR Number: 3834150-5Report Type:Periodic Company Report #US_010668124 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS 10 MG/AT Initial or Prolonged Health BEDTIME Professional Depakote(Valproate Other Semisodium) C Date:11/29/01ISR Number: 3834151-7Report Type:Periodic Company Report #US_010668149 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa (Olanzapine) PS 2 YR Initial or Prolonged Fatigue Celexa (Citalopram Hydrobromide) C Prilosec (Omeprazole) C Date:11/29/01ISR Number: 3834152-9Report Type:Periodic Company Report #US_010668176 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Consumer Zyprexa (Olanzapine) PS 7.5 MG/1 DAY 4 YR Date:11/29/01ISR Number: 3834153-0Report Type:Periodic Company Report #US_010667903 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 1611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3834154-2Report Type:Periodic Company Report #US_010667909 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Zyprexa PS Initial or Prolonged Professional Date:11/29/01ISR Number: 3834155-4Report Type:Periodic Company Report #US_010667842 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3834156-6Report Type:Periodic Company Report #US_010667615 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Consumer Zyprexa PS Initial or Prolonged Blood Testosterone Benztropine C Decreased Benadryl C Libido Decreased Psychotic Disorder Date:11/29/01ISR Number: 3834157-8Report Type:Periodic Company Report #US_010667555 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 6 MG DAY Initial or Prolonged Suicide Attempt Health Fluoxetine SS 75 MG DAY Professional Lorazepam C Date:11/29/01ISR Number: 3834158-XReport Type:Periodic Company Report #US_010667287 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 15 MG AT Initial or Prolonged Health BEDTIME Professional Placebo SS 3 DSG FORM IN THE MORNING Olanzapine C Elavil C Xanax C Effexor C Tylenol C Albuterol C Tylenol Sinus C Date:11/29/01ISR Number: 3834159-1Report Type:Periodic Company Report #US_010667293 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 2 DSG Initial or Prolonged Health FORM/DAY Professional Placebo SS 2 DSG FORM/DAY 24-Jun-2005 12:19 PM Page: 1612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zestril C Atenolol C Vioxx C Artane C Hydrodiuril C Aspirin C Date:11/29/01ISR Number: 3834160-8Report Type:Periodic Company Report #US_010667335 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Literature Olanzapine PS 100 MG Initial or Prolonged Priapism Health Gabapentin C Suicide Attempt Professional Paroxetine C Date:11/29/01ISR Number: 3834161-XReport Type:Periodic Company Report #US_010667423 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arthropathy Consumer Zyprexa PS Hospitalization - Communication Disorder Xanax C Initial or Prolonged Dyskinesia Eyelid Ptosis Gait Disturbance Headache Loss Of Consciousness Memory Impairment Neuroleptic Malignant Syndrome Tremor Date:11/29/01ISR Number: 3834162-1Report Type:Periodic Company Report #US_010667146 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Zyprexa PS Professional Prozac SS 20 MG/ 1 DAY Trazodone C Date:11/29/01ISR Number: 3834163-3Report Type:Periodic Company Report #US_010667160 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Consumer Zyprexa PS Initial or Prolonged Abnormal Date:11/29/01ISR Number: 3834216-XReport Type:Periodic Company Report #US_010666987 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine SS 25 MG DAY Professional Maxalt C Tylenol C 24-Jun-2005 12:19 PM Page: 1613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3834221-3Report Type:Periodic Company Report #US_010667028 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Olanzapine PS 2.5 MG DAY Initial or Prolonged Congestive Health Levoxyl C Professional Lasix C Digoxin C Nitroglycerin C Zantac C Isosorbide C Prednisone C Aspirin C Date:11/29/01ISR Number: 3834228-6Report Type:Periodic Company Report #US_010566786 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine SS 75 MG DAY Professional Ativan C Date:11/29/01ISR Number: 3834233-XReport Type:Periodic Company Report #US_010566723 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Study Olanzapine PS 20 MG/DAY Initial or Prolonged Haemorrhage Health Aspirin C Professional Axid C Betapace C Depakote C Effexor C Enulose C Warfarin C Lorazepam C Multivitamin C Desoximetasone C Nizoral Shampoo C Date:11/29/01ISR Number: 3834237-7Report Type:Periodic Company Report #US_010566331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Health Zyprexa PS 15 MG/DAY Initial or Prolonged Professional Company Representative Date:11/29/01ISR Number: 3834242-0Report Type:Periodic Company Report #US_010566359 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Olanzapine PS Initial or Prolonged Paranoia Professional Synthroid C Psychotic Disorder Lasix C Axid C Metamucil C K-Dur C 24-Jun-2005 12:19 PM Page: 1614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pepto-Bismol C Date:11/29/01ISR Number: 3834247-XReport Type:Periodic Company Report #US_010566387 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 1 DSG FORM/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine SS 1 DSG FORM/AT BEDTIME Synthroid C Premarin C Albuterol C Propantheline C Date:11/29/01ISR Number: 3834251-1Report Type:Periodic Company Report #US_010566444 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Study Zyprexa PS 15 MG/AT Initial or Prolonged Health BEDTIME Other Professional Combivir C Sustiva C Multivitamin C Folic Acid C Date:11/29/01ISR Number: 3834252-3Report Type:Periodic Company Report #US_010566451 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa PS 5 MG/DAY Initial or Prolonged Congestive Professional Toxicologic Test Abnormal Date:11/29/01ISR Number: 3834253-5Report Type:Periodic Company Report #US_010566513 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 12 MG DAY Initial or Prolonged Dyspnoea Health Fluoxetine SS 25 MG Oedema Peripheral Professional Rolaids C Metamucil C Prevacid C Ibuprofen C Tums C Alka-Seltzer C Date:11/29/01ISR Number: 3835982-XReport Type:Periodic Company Report #US_010973734 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Olanzapine PS 20 MG/DAY Initial or Prolonged Inadequate Control Health Ativan(Lorazepam) C Disability Professional Glucophage(Metformin Hydrochloride) C Tetracycline C 24-Jun-2005 12:19 PM Page: 1615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flovent(Fluticasone Propionate) C Date:11/29/01ISR Number: 3835983-1Report Type:Periodic Company Report #US_010973742 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa(Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3835984-3Report Type:Periodic Company Report #US_010973836 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa(Olanzapine) PS 7.5 MG/DAY 2 WK Initial or Prolonged Difficulty In Walking Professional Levoxyl(Levothyroxin Dysphagia Company e Sodium) C Mental Status Changes Representative Muscle Rigidity Pyrexia Tremor Date:11/29/01ISR Number: 3835985-5Report Type:Periodic Company Report #US_010973874 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Study Olanzapine PS 2.5 MG DAY Initial or Prolonged Health Exelon(Rivastigmine Professional Tartrate) C Lomotil C Fosamax(Alendronate Sodium) C Tylenol (Rofecoxib) C Date:11/29/01ISR Number: 3835986-7Report Type:Periodic Company Report #US_010973920 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa(Olanzapine) PS 10 MG/1 DAY Professional Nortriptyline C Company Lithium C Representative Date:11/29/01ISR Number: 3835987-9Report Type:Periodic Company Report #US_010973921 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis B Health Zyprexa(Olanzapine) PS 40 MG/DAY Initial or Prolonged Leukopenia Professional Other Prescribed Overdose Company Pyrexia Representative Thrombocytopenia 24-Jun-2005 12:19 PM Page: 1616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3835988-0Report Type:Periodic Company Report #US_010973485 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa(Olanzapine) PS Initial or Prolonged Somnolence Professional Company Representative Date:11/29/01ISR Number: 3835989-2Report Type:Periodic Company Report #US_010973495 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Study Olanzapine PS 5 MG/AT Initial or Prolonged Health BEDTIME Professional Clonzepam C Multivitamin C Date:11/29/01ISR Number: 3835990-9Report Type:Periodic Company Report #US_010973274 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Zyprexa(Olanzapine) PS 15 MG/AT Initial or Prolonged Health BEDTIME Professional Valium (Diazepam) C Enalapril C Date:11/29/01ISR Number: 3835991-0Report Type:Periodic Company Report #US_010973418 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa(Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Professional Company Representative Date:11/29/01ISR Number: 3835992-2Report Type:Periodic Company Report #US_001051320 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Olanzapine PS 162 MG/DAY Initial or Prolonged Suicidal Ideation Health Fluoxetine Suicide Attempt Professional (Fluoxetine Hydrochloride) SS 25 MG/ 1 DAY Tylenol (Paracetamol) C Bc Powder C Tums C Rolaids (Dihydroxyaluminum Sodium Carbonate) C Alka-Seltzer C 24-Jun-2005 12:19 PM Page: 1617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3835993-4Report Type:Periodic Company Report #US_001051344 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Zyprexa (Olanzapine) PS 25 MG/ DAY Initial or Prolonged Increased Benztropine C Other Aspartate Lithium C Aminotransferase Clarithromycin C Increased Lorazepam C Blood Lactate Robitussin Dehydrogenase Increased (Guaifenesin) C Convulsion Divalproex Sodium C Neuroleptic Malignant Syndrome Overdose Date:11/29/01ISR Number: 3835994-6Report Type:Periodic Company Report #US_001051222 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa (Olanzapine) PS 20 MG/DAY 6 MON Initial or Prolonged Loss Of Consciousness Professional Trazodone C Other Company Representative Date:11/29/01ISR Number: 3835995-8Report Type:Periodic Company Report #US_001051185 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Study Olanzapine PS Initial or Prolonged Health Ativan (Lorazepam) C Professional Chloral Hydrate C Clonidine C Date:11/29/01ISR Number: 3835996-XReport Type:Periodic Company Report #US_001051188 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Increased Professional Zoladex (Goserelin) C Blood Urea Increased Company Nilutamide C Depressed Level Of Representative Consciousness Ketoacidosis Overdose Date:11/29/01ISR Number: 3835997-1Report Type:Periodic Company Report #US_001051847 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Consumer Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Fall 24-Jun-2005 12:19 PM Page: 1618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3835998-3Report Type:Periodic Company Report #US_001051509 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Zyprexa (Olanzapine) PS Initial or Prolonged Professional Company Representative Date:11/29/01ISR Number: 3835999-5Report Type:Periodic Company Report #US_001051519 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Study Olanzapine PS 20 MG/ 1 AT Initial or Prolonged Convulsion Health BEDTIME Depression Suicidal Professional Synthroid (Levothyroxine Sodium) C Tylenol (Paracetamol) C Date:11/29/01ISR Number: 3836000-XReport Type:Periodic Company Report #US_001051448 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 15 MG/DAY Syndrome Professional Company Representative Date:11/29/01ISR Number: 3836001-1Report Type:Periodic Company Report #US_001052101 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Olanzapine PS 10 MG/ 1 DAY Life-Threatening Health Professional Date:11/29/01ISR Number: 3836002-3Report Type:Periodic Company Report #US_001052440 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Olanzapine PS 12.5 MG / 1 Initial or Prolonged Suicidal Ideation Health IN THE Professional EVENING 26 DAY Citalopram C Lithium C Bisacodyl C Metamucil (Psyllium Hydrophilic Mucilloid) C Colace C Multivitamins C 24-Jun-2005 12:19 PM Page: 1619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836003-5Report Type:Periodic Company Report #US_001052448 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Study Nortriptyline PS 100 MG Initial or Prolonged Health Olanzapine SS 12 MG/ 1 DAY Professional Fluoxetine (Fluoxetine Hydrochloride) SS 25MG/1 DAY Nitro Patch (Glyceril Trinitrate) C Zocor (Simvastatin) C Folic Acid C Date:11/29/01ISR Number: 3836004-7Report Type:Periodic Company Report #US_001152834 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG/ 1 DAY Initial or Prolonged Health Fluoxetine Professional Hydrochloride SS 50 MG/ 1 DAY Premarin (Estrogen Conjugated) C Singulair (Montelukast Sodium) C Serevent Inhaler C Proventil Inhaler (Salbutamol) C Metamucil (Psyllium Hydrophylic Mucilloid) C Zestril (Lisinopril) C Baycol (Cerivastatin Sodium) C Date:11/29/01ISR Number: 3836005-9Report Type:Periodic Company Report #US_001152950 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Consumer Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Increased Fall Loss Of Consciousness Muscle Rigidity Date:11/29/01ISR Number: 3836006-0Report Type:Periodic Company Report #US_001152994 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Zyprexa Initial or Prolonged Increased Professional (Olanzapine) PS 5 MG/DAY Blood Triglycerides Company Carbamazepine C Increased Representative Diabetes Mellitus 24-Jun-2005 12:19 PM Page: 1620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836007-2Report Type:Periodic Company Report #US_001153012 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Hyponatraemia Professional Serzone (Nefazodone Other Hydrochloride) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3836008-4Report Type:Periodic Company Report #US_001153021 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS Phosphokinase Increased Professional Company Representative Date:11/29/01ISR Number: 3836009-6Report Type:Periodic Company Report #US_010463080 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Zyprexa (Olanzapine) PS 15 MG AT Initial or Prolonged Congestive Health BEDTIME Obstructive Airways Professional Diovan (Valsartan) C Disorder Hydrochlorothiazide C Glipizide C Levothyroxine C Prevacid (Lansoprazole) C Tegretol (Carbamazepine) C Lasix (Furosemide) C Trazodone C Vitoplex Plus C Date:11/29/01ISR Number: 3836010-2Report Type:Periodic Company Report #US_010362805 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3836012-6Report Type:Periodic Company Report #US_010362903 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 1 YR Initial or Prolonged Professional Desyrel (Trazodone Company Hydrochloride) C Representative 24-Jun-2005 12:19 PM Page: 1621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836013-8Report Type:Periodic Company Report #US_010362974 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Olanzapine PS 6 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG AT BEDTIME Valium (Diazepam) C Celebrex (Celecoxib) C Date:11/29/01ISR Number: 3836014-XReport Type:Periodic Company Report #US_010362609 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Consumer Zyprexa (Olanzapine) PS 20 MG/2 DAY Initial or Prolonged Overdose Buspar (Buspirone Hydrochloride) C Depakote (Valproate Semisodium) C Tegretol (Carbamazepine) C Trazodone C Celexa (Citalopram Hydrobromide) C Xanax (Alprazolam) C Tylenol W/Codeine No. 4 C Date:11/29/01ISR Number: 3836015-1Report Type:Periodic Company Report #US_010362335 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Zyprexa (Olanzapine) PS 5 MG/DAY Cardiac Arrest Professional Syncope Date:11/29/01ISR Number: 3836016-3Report Type:Periodic Company Report #US_010362340 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketoacidosis Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3836017-5Report Type:Periodic Company Report #US_010362364 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Schizoaffective Disorder Study Olanzapine PS 10 MG/DAY Hospitalization - Therapeutic Agent Health Depakote(Valproate Initial or Prolonged Toxicity Professional Semisodium) C Clonazepam C Effexor(Venlafaxine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate C Date:11/29/01ISR Number: 3836018-7Report Type:Periodic Company Report #US_010362401 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Olanzapine PS 12 MG/1 IN Initial or Prolonged Diabetic Ulcer Health THE EVENING Disability Osteomyelitis Acute Professional Fluoxetine Pneumonia (Fluoxetine Hydrochloride) SS 25 MG/1 IN THE EVENING Insulin Humulin C Glucophage (Metformin Hydrochloride) C Accupril (Quinapril Hydrochloride) C Lasix (Furosemide) C Klor-Con(Potassium Chloride) C Folic Acid C Erythromycin C Naproxen C Ativan (Lorazepam) C Amaryl (Glimepiride) C Humulin R (Insulin Human) C Vitamin C C Mevacor (Lovastatin) C Feosol (Ferrous Sulfate) C Lotensin (Benazepril Hydrochloride) C Date:11/29/01ISR Number: 3836019-9Report Type:Periodic Company Report #US_010362408 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine PS 3 DSG FORM AT Initial or Prolonged Paranoia Health BEDTIME Professional Placebo SS 2 DSG FORM/2 DAY Diazepam C Fosinopril C Insulin Novolin C Metformin C Date:11/29/01ISR Number: 3836020-5Report Type:Periodic Company Report #US_010362412 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Study Olanzapine PS 2 DSG FORM Hospitalization - Complete Health DAY Initial or Prolonged Professional Vitamin C C Colace (Docusate Sodium) C Ferrous Sulfate C 24-Jun-2005 12:19 PM Page: 1623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toprol Xl (Metoprolol Succinate) C Fosamax (Alendronate Sodium) C Citracal With Vitamin D C Date:11/29/01ISR Number: 3836021-7Report Type:Periodic Company Report #US_010362247 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Professional Remeron Company (Mirtazapine) C Representative Date:11/29/01ISR Number: 3836022-9Report Type:Periodic Company Report #US_010362248 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Health Zyprexa (Olanzapine) PS 10 MG/DAY Blood Glucose Increased Professional Lithium C Lipase Increased Verapamil C Hydorchlorothiazide C Date:11/29/01ISR Number: 3836023-0Report Type:Periodic Company Report #US_010361818 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 10 MG AT Initial or Prolonged Cognitive Disorder Health BEDTIME Thinking Abnormal Professional Placebo SS Clomipramine C Date:11/29/01ISR Number: 3836024-2Report Type:Periodic Company Report #US_010361819 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa (Olanzapine) PS 10 MG/DAY 1 YR Initial or Prolonged Asthenia Professional Blood Glucose Increased Confusional State Headache Vomiting Date:11/29/01ISR Number: 3836025-4Report Type:Periodic Company Report #US_010361822 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Acute Study Olanzapine PS 15 MG/AT Hospitalization - Therapeutic Agent Health BEDTIME Initial or Prolonged Toxicity Professional Eskalith(Lithium Carbonate) C Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 1624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Norvasc (Amlodipine Besilate) C Date:11/29/01ISR Number: 3836026-6Report Type:Periodic Company Report #US_010361877 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS Initial or Prolonged Health Fluoxetine(Fluoxetin Professional e Hydrochloride) SS Ativan(Lorazepam) C Date:11/29/01ISR Number: 3836027-8Report Type:Periodic Company Report #US_010361882 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa (Olanzapine) PS 5 MG/1 AT Hypertriglyceridaemia Professional BEDTIME 2 MON Depakote (Valproate Semisodium) C (Oxaprozin) C Baycol (Cerivastatin Sodium) C Date:11/29/01ISR Number: 3836028-XReport Type:Periodic Company Report #US_010361895 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Olanzapine PS 10 MG AT Initial or Prolonged Post-Traumatic Stress Health BEDTIME Disorder Professional Placebo SS Date:11/29/01ISR Number: 3836029-1Report Type:Periodic Company Report #US_010361992 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa (Olanzapine) PS 20 MG/DAY FEW Initial or Prolonged Polydipsia Professional MONTHS Polyuria Gabapentin C Urine Ketone Body Present Date:11/29/01ISR Number: 3836030-8Report Type:Periodic Company Report #US_010362022 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Lamotrigine C Professional Divalproex Sodium C Ortho Tri-Cyclen C 24-Jun-2005 12:19 PM Page: 1625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836031-XReport Type:Periodic Company Report #US_010361468 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG/1 DAY Initial or Prolonged Suicidal Ideation Health Fluoxetine(Fluoxetin Professional e Hydrochloride) SS 75 MG/1 DAY Centrum C Selenium C Vitamin E C Vitamin Ca C Date:11/29/01ISR Number: 3836032-1Report Type:Periodic Company Report #US_010361495 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Health Zyprexa (Olanzapine) PS 15 MG/1DAY Initial or Prolonged Professional Date:11/29/01ISR Number: 3836033-3Report Type:Periodic Company Report #US_010361570 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Buccoglossal Syndrome Consumer Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Joint Stiffness Risperdal Muscle Spasms (Risperidone) C Tremor Buspar (Buspirone Hydrochloride) C Xanax (Alprazolam) C Ditropan (Oxybutynin) C Ultram C Date:11/29/01ISR Number: 3836034-5Report Type:Periodic Company Report #US_010361634 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine PS 20 MG DAY Initial or Prolonged Agitation Health Naproxen C Professional Lorazepam C Date:11/29/01ISR Number: 3836035-7Report Type:Periodic Company Report #US_010361109 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Study Olanzapine PS 12 MG DAY Initial or Prolonged Dyspnoea Exertional Health Fluoxetine Electrocardiogram T Wave Professional (Fluoxetine Inversion Hydrochloride) SS 25 MG DAY Celebrex (Celecoxib) C Imitrex (Sumatriptan Succinate) C Fioricet C Estrace (Estradiol) C Tylenol (Paracetamol) C Aspirin C 24-Jun-2005 12:19 PM Page: 1626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836036-9Report Type:Periodic Company Report #US_010361193 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Nizatidine Initial or Prolonged Health (Nizatidine) PS 300 MG/2 DAY Professional Olanzapine SS 15 MG DAY Ativan (Lorazepam) C Date:11/29/01ISR Number: 3836037-0Report Type:Periodic Company Report #US_010361198 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 1 DSG Initial or Prolonged Health FORM/DAY Professional Fluoxetine (Fluoxetine Hydrocloride) SS 1 DSG FORM/DAY Date:11/29/01ISR Number: 3836038-2Report Type:Periodic Company Report #US_010361324 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Study Olanzapine PS 5 MG DAY Hallucination Health Klonopin Professional (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Metoprolol Tartrate C Detrol (Tolterodine L-Tartrate) C Zocor (Simvastatin) C Vitamin E C Ogen (Estropipate) C Ginkoba (Ginkgo Tree Levels Extract) C Zestril (Lisinopril) C Guaifenesin C Erytromec (Erthromycin Stearate) C Date:11/29/01ISR Number: 3836039-4Report Type:Periodic Company Report #US_010360924 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petit Mal Epilepsy Health Zyprexa (Olanzapine) PS 5 MG/DAY 2 WK Professional Tefretol (Carbamzepine) C Date:11/29/01ISR Number: 3836040-0Report Type:Periodic Company Report #US_010360951 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 10 MG AT Initial or Prolonged Hallucination, Auditory Health BEDTIME Paranoia Professional Placebo SS 24-Jun-2005 12:19 PM Page: 1627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trilafon (Perphenazine) C Trazodone C Zolpidem C Sertraline Hydrochloride C Furosemide C Potassium Chloride C Date:11/29/01ISR Number: 3836041-2Report Type:Periodic Company Report #US_010260691 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Mircette C Multivitamin C Prempro C Asa (Acetylsalicyclic Acid) C Zantac (Ranitidine Hydrochloride) C Date:11/29/01ISR Number: 3836074-6Report Type:Periodic Company Report #US_010872706 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Olanzapine SS 15 MG/DAY Professional Ativan (Lorazepam) C Aspirin C Propanolol C Date:11/29/01ISR Number: 3836075-8Report Type:Periodic Company Report #US_010872452 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Professional Wellbutrin Company (Amfebutamone Representative Hydrochloride) C Date:11/29/01ISR Number: 3836076-XReport Type:Periodic Company Report #US_010872584 Age:75 YR Gender:Female I/FU:I Outcome PT Other Blood Alkaline Phosphatase Increased Blood Chloride Decreased Blood Electrolytes Abnormal Blood Potassium Increased Blood Pressure Fluctuation 24-Jun-2005 12:19 PM Page: 1628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Sodium Decreased Decreased Appetite Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration Nausea Health Zyprexa (Olanzapine) PS 15 MG/DAY Protein Urine Present Professional Norvasc (Amlodipine Pyrexia Besilate) C Syncope Catapressan (Clonidine) C Atenolol C Chloral Hydrate C Bentyl (Dicycloverine Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Evista (Raloxifene .Hydrochloride) C Date:11/29/01ISR Number: 3836079-5Report Type:Periodic Company Report #US_010872284 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 10 MG/DAY Initial or Prolonged Impulsive Behaviour Health Ativan (Lorazepam) C Professional Wellbutrin (Amfebutamone Hydrochloride) C Atarax (Hydroxyzine Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Date:11/29/01ISR Number: 3836080-1Report Type:Periodic Company Report #US_010872076 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Literature Olanzapine PS 20 MG/DAY Initial or Prolonged Headache Health Risperidone C Insulin-Requiring Type Ii Professional Venlafaxine C Diabetes Mellitus Valproic Acid C Upper Respiratory Tract Atorvastatin C Infection Propranolol C Weight Increased Paroxetine C Ibuprofen C Date:11/29/01ISR Number: 3836083-7Report Type:Periodic Company Report #US_010871889 Age:15 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Acute Stress Disorder Other Aggression Anxiety Depression Fear Intentional Self-Injury 24-Jun-2005 12:19 PM Page: 1629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Muscle Spasms Report Source Product Role Manufacturer Route Dose Duration Visual Disturbance Consumer Zyprexa (Olanzapine) PS Weight Increased Prozac (Fluoxetine Hydrochloride) SS Date:11/29/01ISR Number: 3836090-4Report Type:Periodic Company Report #US_010871914 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Olanzapine SS 30 MG/DAY Professional Ambien (Zolpidem Tartrate) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3836105-3Report Type:Periodic Company Report #US_010871930 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Drooling Professional Ritalin Tremor Company (Methylphenidate Representative Hydrochloride) C Adderall C Clonidine C Date:11/29/01ISR Number: 3836125-9Report Type:Periodic Company Report #US_010260340 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Quetiapine PS 400 MG/DAY Initial or Prolonged Health Olanzapine SS 15 MG/DAY Professional Olanzapine SS 20 MG/DAY Xanax (Alprazolam) C Albuterol C Date:11/29/01ISR Number: 3836126-0Report Type:Periodic Company Report #US_010260350 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 2.5 MG/DAY Initial or Prolonged Pneumonia Health Vitamins Nos C Professional Synthroid (Levothyroxine Sodium) C Miacalcin (Calcitonin, Salmon) C Vitamin E C Ditropan (Oxybutynin) C Premarin Vaginal Cream (Estrogens Conjugated) C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin (Amfebutamone Hydrochloride) C Date:11/29/01ISR Number: 3836127-2Report Type:Periodic Company Report #US_010260360 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Study Olanzapine PS 10 MG/AT Initial or Prolonged Obstruction Health BEDTIME Professional Date:11/29/01ISR Number: 3836128-4Report Type:Periodic Company Report #US_010260428 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 10 MG/DAY Professional Neurontin (Gabapentin) C Date:11/29/01ISR Number: 3836129-6Report Type:Periodic Company Report #US_010260531 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Olanzapine PS 15 MG AT Initial or Prolonged Health BEDTIME Professional Placebo SS Zyprexa (Olanzapine) SS 20 MG AT BEDTIME Lorazepam C Date:11/29/01ISR Number: 3836130-2Report Type:Periodic Company Report #US_010260531 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Olanzapine PS 15 MG AT Initial or Prolonged Health BEDTIME Professional Placebo SS Zyprexa (Olanzapine) SS 20 MG AT BEDTIME Lorazepam C Date:11/29/01ISR Number: 3836131-4Report Type:Periodic Company Report #US_010260544 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine PS 20 MG/DAY Initial or Prolonged Suicidal Ideation Health Professional 24-Jun-2005 12:19 PM Page: 1631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836132-6Report Type:Periodic Company Report #US_010260630 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Obstructive Study Olanzapine PS 15 MG/DAY Hospitalization - Pulmonary Disease Health Buspar (Buspirone Initial or Prolonged Oxygen Saturation Professional Hydrochloride) C Decreased Date:11/29/01ISR Number: 3836133-8Report Type:Periodic Company Report #US_010259616 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Health Zyprexa (Olanzapine) PS Professional Date:11/29/01ISR Number: 3836134-XReport Type:Periodic Company Report #US_010259583 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Zyprexa (Olanzapine) PS 3 MON Initial or Prolonged Professional Reglan Disability Company (Metoclopramide) C Representative Date:11/29/01ISR Number: 3836892-4Report Type:Periodic Company Report #US_010259313 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Pollakiuria Professional Company Representative Date:11/29/01ISR Number: 3836893-6Report Type:Periodic Company Report #US_010158788 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG/DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG/DAY Olanzapine SS Tylenol (Paracetamol) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3836895-XReport Type:Periodic Company Report #US_010158263 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Professional Company Representative 24-Jun-2005 12:19 PM Page: 1632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836896-1Report Type:Periodic Company Report #US_010158314 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Prozac (Fluoxetine Initial or Prolonged Professional Hydrochloride) PS Zyprexa (Olanzapine) SS Lamictal (Lamotrigine) C Date:11/29/01ISR Number: 3836897-3Report Type:Periodic Company Report #US_010158325 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Diabetes Mellitus Health Paxil (Paroxetine Non-Insulin-Dependent Professional Hydrochloride) C Fatigue Ritalin (Methylphenidate Hydrochloride) C Date:11/29/01ISR Number: 3836898-5Report Type:Periodic Company Report #US_010158401 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 20 MG/1 AT Initial or Prolonged Health BEDTIME Professional Olanzapine SS 20 MG/1 AT BEDTIME Placebo SS Placebo SS Galenic /Polymyxin B/Neomycin/Bactracin C Ipratropium Bromide C Divalproex Sodium C Aspirin C Digoxin C Glyburide C Fosinopril C Simvastatin C Terazosin C Lorazepam C Olanazapine C Date:11/29/01ISR Number: 3836899-7Report Type:Periodic Company Report #US_010158410 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa (Olanzapine) PS 30 MG/DAY 7 MON Initial or Prolonged Derealisation Health Haldol Decanoate Hallucination Professional (Haloperidol Overdose Decanoate) C Social Avoidant Behaviour 24-Jun-2005 12:19 PM Page: 1633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3836900-0Report Type:Periodic Company Report #US_010158515 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3836901-2Report Type:Periodic Company Report #US_010158526 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 7.5 MG/DAY Professional Company Representative Date:11/29/01ISR Number: 3836902-4Report Type:Periodic Company Report #US_010158539 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY 17 MON Initial or Prolonged Nausea Professional Depakene (Valproate Other Pyrexia Sodium) C Vomiting Clonopin Weight Decreased (Clonazepam) C Prevacid (Lansoprazole) C Asthmacort C Colace (Ducosate Sodium) C Date:11/29/01ISR Number: 3836903-6Report Type:Periodic Company Report #US_010158615 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Increased Appetite Consumer Zyprexa (Olanzapine) PS 40 MG/ DAY Initial or Prolonged Medication Error Schizophreniform Disorder Sluggishness Date:11/29/01ISR Number: 3836904-8Report Type:Periodic Company Report #US_010158657 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Zyprexa (Olanzapine) PS 10 MG/ 2 DAY Initial or Prolonged Professional Claritin Company (Loratadine) C Representative Date:11/29/01ISR Number: 3836905-XReport Type:Periodic Company Report #US_010158719 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Ketoacidosis Health Initial or Prolonged Professional 24-Jun-2005 12:19 PM Page: 1634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 20 MG/ DAY Date:11/29/01ISR Number: 3836906-1Report Type:Periodic Company Report #US_010157830 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Study Olanzapine PS 2.5 MG/ DAY Initial or Prolonged Airways Disease Health Wellbutrin Exacerbated Professional (Amfebutamone Myocardial Infarction Hydrochloride) C Celebrex (Celecoxib) C Tequin (Gatifloxacin) C Topamax (Topiramate) C Digoxin C Vicodin C Valium (Diazepam) C Prevacid (Lansoprazole) C Xanax (Alprazolam) C Rythmol (Propafenone) C Flovent (Fluticasone Propionate) C Date:11/29/01ISR Number: 3836907-3Report Type:Periodic Company Report #US_010157832 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zypreza (Olanzapine) PS 7.5 MG/DAY 3 YR Initial or Prolonged Drug Effect Decreased Schizoaffective Disorder Date:11/29/01ISR Number: 3836908-5Report Type:Periodic Company Report #US_010157965 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 3 DSG FORM/ Initial or Prolonged Health DAY Professional Neosporin Ointment C Chloral Hydrate C Tylenol (Paracetamol) C Date:11/29/01ISR Number: 3836909-7Report Type:Periodic Company Report #US_010158164 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Localised Infection Study Zyprexia Initial or Prolonged Health (Olanzapine) PS 2.5 MG/ AT Professional BEDTIME Prozac (Fluoxetine Hydrochloride) C Procardia 24-Jun-2005 12:19 PM Page: 1635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nifedipine) C Ecotrin (Acetylsalicylic Acid) C Date:11/29/01ISR Number: 3836910-3Report Type:Periodic Company Report #US_010157695 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Literature Olanzapine PS 30 MG/ 1 DAY 2 WK Health Professional Date:11/29/01ISR Number: 3836911-5Report Type:Periodic Company Report #US_010157699 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Literature Olanzapine PS 30 MG/ 1 DAY Neutropenia Health Weight Increased Professional Date:11/29/01ISR Number: 3836912-7Report Type:Periodic Company Report #US_010157728 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subarachnoid Haemorrhage Study Olanzapine PS 6M/1 IN THE Initial or Prolonged Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG/1 IN THE EVENING Ziac C Progesterone C Premarin (Estrogens Conjugated) C Flovent (Fluticasone Propionate) C Alupent (Orciprenaline Sulfate) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3836913-9Report Type:Periodic Company Report #US_010157737 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 2.5 MG DAY Hospitalization - Respiratory Failure Health Diltiazem C Initial or Prolonged Sepsis Professional Enulose (Lactulose) C Evista (Raloxifene Hydrochloride) C Furosemide C K-Dur (Potassium Chloride) C Os-Cal C Zantac (Ranitidine Hydrochloride) C Zoloft (Sertraline 24-Jun-2005 12:19 PM Page: 1636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/29/01ISR Number: 3836914-0Report Type:Periodic Company Report #US_010157360 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa (Olanzapine) PS 25 MG/ 4 DAY Phosphokinase Increased Professional Depakote (Valproate Loss Of Consciousness Company Semisodium) C Overdose Representative Lithium C Cogentin (Benzatropine Mesilate) C Date:11/29/01ISR Number: 3836915-2Report Type:Periodic Company Report #US_010157429 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Study Olanzapine PS 5 MG/AT Health BEDTIME Professional Date:11/29/01ISR Number: 3836916-4Report Type:Periodic Company Report #US_010157452 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG/AT BEDTIME Lorazepam C Date:11/29/01ISR Number: 3836917-6Report Type:Periodic Company Report #US_010157495 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 6 DSG FORM Initial or Prolonged Deep Vein Thrombosis Health Placebo SS 3 DSG FORM/AT Diabetic Ketoacidosis Professional BEDTIME Hyperglycaemia Trazodone C Sinusitis Albuterol C Ipratropium C Cetirizine C Fluticasone C Montelukast C Amoxicillin C Haldol (Haloperidol) C Lansoprazole C Combivent C Colace (Docusate Sodium) C Ferrous Sulfate C K-Dur (Potassium Chloride) C Prednisone C Flexeril 24-Jun-2005 12:19 PM Page: 1637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Cyclobenzaprine Hydrochloride) C Ascorbic Acid C Date:11/29/01ISR Number: 3836918-8Report Type:Periodic Company Report #US_010157504 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Olanzapine PS 15 MG/1 DAY Hospitalization - Congestive Health Placebo SS 1 DSG FORM/2 Initial or Prolonged Chronic Obstructive Professional DAY Airways Disease Furosemide C Exacerbated Potassium Chloride C Captopril C Digoxin C Albuterol C Levaquin (Levofloxacin) C Ipratropium Bromide C Date:11/29/01ISR Number: 3836919-XReport Type:Periodic Company Report #US_010157535 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Literature Olanzapine PS 30 MG DAY Health Haloperidol Professional Decanoate C Clozapine C Carbamazepine C Date:11/29/01ISR Number: 3836920-6Report Type:Periodic Company Report #US_010157572 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Literature Olanzapine PS 15 MG/AT Initial or Prolonged Health BEDTIME Professional Haloperidol C Lithium C Valproic Acid C Date:11/29/01ISR Number: 3836925-5Report Type:Periodic Company Report #US_010157580 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Literature Olanzapine PS 10 MG/DAY Initial or Prolonged Health Perphenazine C Professional Valproic Acid C Lithium C Risperidone C Clozapine C Date:11/29/01ISR Number: 3836928-0Report Type:Periodic Company Report #US_010157585 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa (Olanzapine) PS 35 MG/DAY 2 YR Initial or Prolonged Suicidal Ideation Professional Depakote (Valproate 24-Jun-2005 12:19 PM Page: 1638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Neurontin (Gabapentin) C Lamictal (Lamotrigine) C Amitriptyline C Date:11/29/01ISR Number: 3836929-2Report Type:Periodic Company Report #US_010157590 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Murder Study Olanzapine PS 6 MG/1 IN THE Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 IN THE MORNING Synthroid (Levothyroxine Sodium) C Actos (Pioglitazone) C Humulin 70/30 C Ibuprofen C Date:11/29/01ISR Number: 3836930-9Report Type:Periodic Company Report #US_010157604 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Health Zyprexa (Olanzapine) PS Initial or Prolonged Hypersensitivity Professional Company Representative Date:11/29/01ISR Number: 3836931-0Report Type:Periodic Company Report #US_010157608 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Hallucination Date:11/29/01ISR Number: 3836933-4Report Type:Periodic Company Report #US_010157612 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Olanzapine PS 6 MG/1 DAY Initial or Prolonged Inadequate Control Health Fluoxetine Hyperglycaemia Professional (Fluoxetine Ketoacidosis Hydrochloride) SS 25 MG/1 DAY Covera (Verapamil Hydrochloride) C Accupril (Quinapril Hydrochloride) C Synthroid (Levothyroxine Sodium) C Furosemide C Multivitamin C Univasc (Moexipril 24-Jun-2005 12:19 PM Page: 1639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/29/01ISR Number: 3836935-8Report Type:Periodic Company Report #US_010157177 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Neuroleptic Malignant Professional Other Syndrome Company Representative Date:11/29/01ISR Number: 3836938-3Report Type:Periodic Company Report #US_001256004 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Olanzapine PS 2 DSG FORM/AT Initial or Prolonged Pneumonia Health BEDTIME Professional Aspirin C Peri-Colace C Tylenol (Paracetamol) C Robitussin (Guaifenesin) C Percocet C Date:11/29/01ISR Number: 3836940-1Report Type:Periodic Company Report #US_001256007 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 5 MG/DAY 1 WK Professional Neurontin Company (Gabapentin) C Representative Serentil (Mesoridazine) C Date:11/29/01ISR Number: 3836941-3Report Type:Periodic Company Report #US_001256013 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 5 MG/DAY 3 MON Professional Ativan (Lorazepam) C Company Dilantin (Phenytoin Representative Sodium) C .. C Date:11/29/01ISR Number: 3836942-5Report Type:Periodic Company Report #US_001256031 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Suicidal Ideation Health Professional 24-Jun-2005 12:19 PM Page: 1640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3837030-4Report Type:Periodic Company Report #US_991029545 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Drug Abuser Health Motrin (Ibuprofen) C Other Self Mutilation Professional Norethindrone C Self-Injurious Ideation Prenatal C Suicide Attempt Depakote(Valproate Semisodium) C Klonopin (Clonazepam) C Esgic C Multivitamin C Date:11/29/01ISR Number: 3837035-3Report Type:Periodic Company Report #US_991029571 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Study Olanzapine PS 2 DSG Hospitalization - Depression Suicidal Health FORM/DAY Initial or Prolonged Suicidal Ideation Professional Placebo SS 2 DSG FORM/1 Suicide Attempt AT BEDTIME Depakote (Valproate Semisodium) C Premarin (Estorgens Congugated) C Multivitamin C Ativan(Lorazepam) C Aleve (Naproxen Sodium) C Calcium C Date:11/29/01ISR Number: 3837036-5Report Type:Periodic Company Report #US_991029697 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Olanzapine PS 15 MG/1 AT Initial or Prolonged Paranoia Health BEDTIME Schizophrenia Professional Placebo SS 1 DSG FORM/2 Suicidal Ideation DAY Divalproex Sodium C Lorazepam C Clotrimazole C Date:11/29/01ISR Number: 3837037-7Report Type:Periodic Company Report #US_991029710 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthralgia Study Olanzapine PS 2.5 MG/1 DAY Hospitalization - Dementia Health Amaryl (Glimepiride) C Initial or Prolonged Professional Aricept (Donepezil Hydrochloride) C Peri-Colace C Furosemide C Lanoxin(Digoxin) C Precose(Acarbose) C K-Dur C Multivitamin C 24-Jun-2005 12:19 PM Page: 1641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zinc Sulfate C Vitamin C C Vitamin E C Imdur(Isosorbide Mononitrate) C Tylenol (Paracetamol) C Milk Of Magnesia C Date:11/29/01ISR Number: 3837038-9Report Type:Periodic Company Report #US_991030245 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 15 MG/1 DAY Initial or Prolonged Delusion Health Levoxyl Paranoia Professional (Levothyroxine Sodium) C Ferrous Sulfate C Artificial Tears C Folic Acid C Zantac(Ranitidine Hydrochloride) C Multivitamin C Buspirone C Carbamazepine C Date:11/29/01ISR Number: 3837039-0Report Type:Periodic Company Report #US_991030481 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 10 MG DAY Initial or Prolonged Health No Study Drug SS Professional Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3837040-7Report Type:Periodic Company Report #US_991030486 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Study Olanzapine PS 2.5 MG/1 DAY Hospitalization - Delusion Health Alphagan(Brimonidine Initial or Prolonged Hallucination Professional Tartrate) C Pneumonia Aricept (Donepezil Sepsis Hydrochloride) C Urinary Tract Infection Aspirin C Imdur (Isosorbide Mononitrate) C Lorazepam C Regulaid C Timolol C Trazodone C Vitamin B12 C Acetaminophen C Florinef (Fludrocortisone Acetate) C Multivitamin C Remeron 24-Jun-2005 12:19 PM Page: 1642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mirtazapine) C Lorazepam C Date:11/29/01ISR Number: 3837041-9Report Type:Periodic Company Report #US_991130583 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Zyprexa (Olanzapine) PS 25 MG/DAY Hospitalization - Schizoaffective Disorder Health Depakene (Valproate Initial or Prolonged Professional Sodium) C Tegretol (Carbamazepine) C Effexor (Venlafaxine Hydrochloride) C Date:11/29/01ISR Number: 3837042-0Report Type:Periodic Company Report #US_991131204 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Pneumonia Health Twocal Hn C Urosepsis Professional Aspirin C Buspar (Buspirone Hydrochloride) C Lorazepam C Milk Of Magnesia C Multivitamin C Vitamin C C Zinc Sulfate C Tylenol (Paracetamol) C Silvadene (Sulfadiazine Silver) C Date:11/29/01ISR Number: 3837043-2Report Type:Periodic Company Report #US_981214696 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 4 DSG FORM/1 Initial or Prolonged Health DAY Professional Valproic Acid C Ecotrin (Acetylsalicylic Acid) C Date:11/29/01ISR Number: 3837044-4Report Type:Periodic Company Report #US_010974298 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Zyprexa (Olanzapine) PS 5 MG/DAY Drooling Professional Lethargy Company Pneumonia Aspiration Representative 24-Jun-2005 12:19 PM Page: 1643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3837045-6Report Type:Periodic Company Report #US_010974098 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Zyprexa (Olanzapine) PS 2.5 MG/1 DAY Professional Company Representative Date:11/29/01ISR Number: 3837047-XReport Type:Periodic Company Report #US_010974104 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3837048-1Report Type:Periodic Company Report #US_010974120 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Consumer Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Diarrhoea Depakote (Valproate Liver Function Test Semisodium) C Abnormal Zoloft (Sertraline Muscle Rigidity Hydrochloride) C Pneumonia Vomiting Date:11/29/01ISR Number: 3837049-3Report Type:Periodic Company Report #US_010974190 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 18 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG AT BEDTIME Date:11/29/01ISR Number: 3837050-XReport Type:Periodic Company Report #US_010974014 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Consumer Zyprexa (Olanzapine) PS 30 MG/1 DAY Hostility Neurontin Prescribed Overdose (Gabapentin) C Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3837051-1Report Type:Periodic Company Report #US_010974020 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Congestive Professional Prozac (Fluoxetine Somnolence Hydrochloride) SS 10 MG/1 DAY Gabapentin C Klonopin (Clonazepam) C Alprazolam C Lorazepam C Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3837052-3Report Type:Periodic Company Report #US_010973529 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Zyprexa (Olanzapine) PS 5 MG/AT Increased Professional BEDTIME Aspartate Company Quetiapine C Aminotransferase Representative Venlafaxinenidine C Increased Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Increased Date:11/29/01ISR Number: 3837053-5Report Type:Periodic Company Report #US_010973535 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 2.5 MG/AT Initial or Prolonged Depressed Mood Health BEDTIME Professional Celexa (Citalopram Hydrobromide) C Calcium And Vitamin D C Date:11/29/01ISR Number: 3837054-7Report Type:Periodic Company Report #US_010973707 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Convulsion Professional Prozac (Fluoxetine Intentional Misuse Company Hydrochloride) SS Suicide Attempt Representative Tachycardia Date:11/29/01ISR Number: 3837061-4Report Type:Periodic Company Report #US_010973211 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Weight Increased 24-Jun-2005 12:19 PM Page: 1645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3837062-6Report Type:Periodic Company Report #US_010973212 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Congestive Professional Weight Increased Company Representative Date:11/29/01ISR Number: 3837063-8Report Type:Periodic Company Report #US_010973240 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Professional Septra C Zovirax (Aciclovir) C Naprosyn (Naproxen) C Prilosec (Omeprazole) C Dilantin (Phenytoin Sodium) C Nizoral (Ketoconazole) C Combivir C Lopinavir C Colace (Docusate Sodium) C Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Megace (Megestrol Acetate) C Elocon (Mometasone Furoate) C Vitamin B12 C Date:11/29/01ISR Number: 3837064-XReport Type:Periodic Company Report #US_010973250 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa (Olanzapine) PS 7 DSG Initial or Prolonged Somnolence Professional FORM/DAY Suicide Attempt Lorazepam C Amantadine C Date:11/29/01ISR Number: 3837065-1Report Type:Periodic Company Report #US_010872870 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 15 MG AT Initial or Prolonged Health BEDTIME Professional Amantadine SS 300 MG DAY Zoloft (Sertraline Hydrochloride) C Lorazepam C Aspirin C Orthocept C 24-Jun-2005 12:19 PM Page: 1646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3837066-3Report Type:Periodic Company Report #US_010972991 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Aggression Health Lithobid (Lithium Dyskinesia Professional Carbonate) C Hunger Methylphenidate Insomnia Hydrochloride C Prescribed Overdose Date:11/29/01ISR Number: 3837067-5Report Type:Periodic Company Report #US_010973033 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa (Olanzapine) PS 12.5 MG/1 DAY Initial or Prolonged Increased Professional Other Blood Triglycerides Increased Blood Urea Increased Diabetic Ketoacidosis Date:11/29/01ISR Number: 3837068-7Report Type:Periodic Company Report #US_010872766 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adjustment Disorder Study Olanzapine PS Initial or Prolonged Mania Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Olanzapine SS 5 MG/DAY Lorazepam C Albuterol C Vicodin C Date:11/29/01ISR Number: 3837069-9Report Type:Periodic Company Report #US_010872773 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Professional Prozac (Fluoxetine Hydrochloride) SS 60 MG/1 DAY Celexa (Citalopram Hydrobromide) C Remeron (Mirtazapine) C Multivitamins Nos (Multivitamins Nos) C Folate Sodium C Iron Sulfate C Date:11/29/01ISR Number: 3837070-5Report Type:Periodic Company Report #US_010872780 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Study Olanzapine PS 18 MG IN THE Initial or Prolonged Health EVENING Professional Fluoxetine 24-Jun-2005 12:19 PM Page: 1647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Fluoxetine Hydrochloride) SS 75 MG IN THE EVENING Ativan (Lorazepam) C Date:11/29/01ISR Number: 3837770-7Report Type:Periodic Company Report #US_010565545 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 5 MG/DAY Initial or Prolonged Suicidal Ideation Health Professional Date:11/29/01ISR Number: 3837771-9Report Type:Periodic Company Report #US_010565397 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 10 MG/DAY 1 MON Professional Company Representative Date:11/29/01ISR Number: 3837772-0Report Type:Periodic Company Report #US_010565399 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3838435-8Report Type:Periodic Company Report #US_000745675 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Study Olanzapine PS 2 DSG FORM/AT Initial or Prolonged Consciousness Health BEDTIME Normal Pressure Professional Zantac (Ranitidine Hydrocephalus Hydrochloride) C Vitamin C C Aspirin C Advil (Ibuprofen) C Date:11/29/01ISR Number: 3838440-1Report Type:Periodic Company Report #US_000746066 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 6 MG/1 DAY Initial or Prolonged Suicide Attempt Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG/1 DAY 24-Jun-2005 12:19 PM Page: 1648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838443-7Report Type:Periodic Company Report #US_000746152 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foot Fracture Study Olanzapine PS Initial or Prolonged Health Placebo C Professional Date:11/29/01ISR Number: 3838450-4Report Type:Periodic Company Report #US_000846584 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Study Fluoxetine PS 50 MG/ 1 IN Hospitalization - Suicide Attempt Health THE EVENING Initial or Prolonged Professional Olanzapine SS 6 MG/ 1 IN THE EVENING Date:11/29/01ISR Number: 3838453-XReport Type:Periodic Company Report #US_000846890 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Olanzapine PS 2.5 MG/ AT Initial or Prolonged Health BEDTIME Professional Pepcid (Famotidine) C Amaryl (Glimepiride) C Atenolol C Cordarone (Amiodarone Hydrochloride) C Furosemide C Evista (Raloxifene Hydrochloride) C Synthroid (Levothyroxine Sodium) C Prinivil (Lisinopril) C K-Dur (Potassium Chloride) C Calcium With Vitamin D C Vitamin E C Aspirin C Xalatan (Latanoprost) C Date:11/29/01ISR Number: 3838460-7Report Type:Periodic Company Report #US_000846912 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Study Olanzapine PS 12 MG/ 1 DAY Initial or Prolonged Breast Cancer Health Fluoxetine Other Dehydration Professional (Fluoxetine Vomiting Hydrochloride) SS 25 MG/ 1 DAY Folic Acid C Vitamin B-6 C Vitamin B12 C Selenium C Betacarotene C 24-Jun-2005 12:19 PM Page: 1649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin C Prempro C Soy C Calcium C Magnesium C Zinc C Calcium And Vitamin D C Iron C Vitamin E C Neurontin (Gabapentin) C Date:11/29/01ISR Number: 3838467-XReport Type:Periodic Company Report #US_000846999 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Study Olanzapine PS 20 MG AT Initial or Prolonged Health BEDTIME Professional Aspirin C Valium (Diazepam) C Date:11/29/01ISR Number: 3838471-1Report Type:Periodic Company Report #US_000847480 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Limb Fracture Study Olanzapine PS 30 MG/ 1AT Initial or Prolonged Overdose Health BEDTIME Disability Suicide Attempt Professional Prozac (Fluoxetine Hydrochloride) C Diovan (Valsartan) C Keflex (Cefalexin Monohydrate) C Darvon (Dextropropoxyphene Hydrochloride) C Tylenol W/Codeine No. 3 C Date:11/29/01ISR Number: 3838476-0Report Type:Periodic Company Report #US_000643532 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicidal Ideation Study Olanzapine PS 10 MG/1 AT Hospitalization - Health BEDTIME Initial or Prolonged Professional Lithium C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3838479-6Report Type:Periodic Company Report #US_000643547 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Study Olanzapine PS 2 DSG FORM Hospitalization - Diverticulitis Health Sertraline C Initial or Prolonged Rectal Haemorrhage Professional Donepezil C Vitamin E C Aspirin C 24-Jun-2005 12:19 PM Page: 1650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Iron C Dulcolax (Bisacodyl) C Bisacodyl C Date:11/29/01ISR Number: 3838482-6Report Type:Periodic Company Report #US_000643670 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 12 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 AT BEDTIME Valium (Diazepam) C Date:11/29/01ISR Number: 3838486-3Report Type:Periodic Company Report #US_000643688 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG Initial or Prolonged Health Nizatidine Professional (Nizatidine) SS 150 MG/2 DAY Date:11/29/01ISR Number: 3838493-0Report Type:Periodic Company Report #US_000644309 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 2.5 MG/1 DAY Initial or Prolonged Hyponatraemia Health Olanzapine SS 5 MG/1 DAY Urinary Tract Infection Professional Tylenol (Paracetamol) C Trazodone C Keflex (Cefalexin Monohydrate) C Depakote (Valproate Semisodium) C Naprosyn (Naproxen) C Maxzide C Synthroid (Levothyroxine Sodium) C Date:11/29/01ISR Number: 3838498-XReport Type:Periodic Company Report #US_000745277 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa (Olanzapine) PS 5 MG/1 AT Initial or Prolonged Suicide Attempt Health BEDTIME Other Professional Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838501-7Report Type:Periodic Company Report #US_000745290 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Olanzapine PS 3 DSG Initial or Prolonged Transient Ischaemic Health FORM/DAY Disability Attack Professional Synthroid (Levothyroxine Sodium) C Allopurinol C Ticlopidine C Ziac C Date:11/29/01ISR Number: 3838504-2Report Type:Periodic Company Report #US_000745447 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Empyema Study Olanzapine PS 3 DSG FORM/1 Hospitalization - Febrile Convulsion Health IN THE Initial or Prolonged Pneumonia Professional EVENING Psychotic Disorder Restoril (Temazepam) C Donepezil C Aspirin C Vitamin E C Percocet C Date:11/29/01ISR Number: 3838505-4Report Type:Periodic Company Report #US_000745565 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 1 MG/2 DAY Fosinopril C Ibuprofen C Milk Of Magnesia C Kaolin/Pectin C Lorazepam C Haloperidol Lactate C Benztropine Mesylate C Aluminium Hydroxide C Date:11/29/01ISR Number: 3838512-1Report Type:Periodic Company Report #US_000745588 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Olanzapine PS 6 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG AT BEDTIME Aspirin C Bactrim C 24-Jun-2005 12:19 PM Page: 1652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838518-2Report Type:Periodic Company Report #US_000542030 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Suicidal Ideation Health AT BEDTIME Professional Tylenol (Paracetamol) C Hydrochlorothiazide C Accupril (Quinapril Hydrochloride) C Synthroid (Levothyroxine Sodium) C Date:11/29/01ISR Number: 3838523-6Report Type:Periodic Company Report #US_000542349 Age:98 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Study Olanzapine PS 2.5 MG/1 DAY Hospitalization - Myocardial Infarction Health Tobramycin Initial or Prolonged Myocardial Ischaemia Professional Ophthalmic Solution C Subdural Haematoma Persantine Urinary Tract Infection (Dipyridamole) C Multivitamin C Vitamin E C Lorazepam C Ensure C Ferrous Sulfate C Date:11/29/01ISR Number: 3838526-1Report Type:Periodic Company Report #US_000542604 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertensive Crisis Study Olanzapine PS 3 DSG FORM Initial or Prolonged Health Accupril (Quinapril Professional Hydrochloride) C Date:11/29/01ISR Number: 3838527-3Report Type:Periodic Company Report #US_000642931 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Date:11/29/01ISR Number: 3838528-5Report Type:Periodic Company Report #US_000642934 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Olanzapine PS 1 DSG FORM/1 Initial or Prolonged Difficulty In Walking Health AT BEDTIME Disability Eating Disorder Professional Vitamins C Hypokinesia Transient Ischaemic Attack 24-Jun-2005 12:19 PM Page: 1653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838529-7Report Type:Periodic Company Report #US_000642940 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Study Olanzapine PS 2 DSG FORM/IN Initial or Prolonged Body Temperature Health THE EVENING Increased Professional Aspirin C Chronic Obstructive Nasonex C Airways Disease Aerobid Exacerbated (Flunisolide) C Palpitations Vitamin B1 C Triamterene C Dulcolax (Bisacodyl) C Multivitamin C Date:11/29/01ISR Number: 3838530-3Report Type:Periodic Company Report #US_000642957 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Weight Decreased Health BEDTIME Professional Placebo SS 1 DSG FORM/2 DAY Lorazepam C Acetaminophen C Date:11/29/01ISR Number: 3838544-3Report Type:Periodic Company Report #US_010565471 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Initial or Prolonged Professional Pepcid (Famotidine) C Mvi (Mvi) C Colace (Docusate Sodium) C Synthroid (Levothyroxine Sodium) C Date:11/29/01ISR Number: 3838551-0Report Type:Periodic Company Report #US_010565304 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Health Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Aminotransferase Professional Vasotec (Enalapril Increased Company Maleate) C Blood Alkaline Representative Zoloft (Sertraline Phosphatase Increased Hydrochloride) C Chills Aricept (Donepezil Confusional State Hydrochloride) C Gait Disturbance Gamma-Glutamyltransferase Increased Pyrexia Urinary Incontinence 24-Jun-2005 12:19 PM Page: 1654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838557-1Report Type:Periodic Company Report #US_010565272 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Olanzapine PS 5 MG/1 AT Health BEDTIME Professional Aricept (Donepezil Hydrochloride) C Synthroid (Levothyroxine Sodium) C Vitamin E C Megace (Megestrol Acetate) C Zoloft (Sertraline Hydrochloride) C Date:11/29/01ISR Number: 3838559-5Report Type:Periodic Company Report #US_010565199 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laceration Study Olanzapine PS 6 MG DAY Initial or Prolonged Multiple Fractures Health Fluoxetine Road Traffic Accident Professional (Fluoxetine Hydrochloride) SS 25 MG DAY Flovent(Fluticasone Propionate) C Albuterol C Premarin(Estrogens Conjugated) C Serevent (Salmeterol Xinafoate) C Date:11/29/01ISR Number: 3838563-7Report Type:Periodic Company Report #US_010565172 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Post-Traumatic Stress Study Olanzapine PS 1 DSG Initial or Prolonged Disorder Health FORM/DAY Professional Fluoxetine (Fluoxetine Hydrochloride) SS 1 DSG FORM/DAY Restoril (Temazepam) C Date:11/29/01ISR Number: 3838566-2Report Type:Periodic Company Report #US_010464695 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa (Olanzapine) PS 5 MG/2 DAY 1 MON Inadequate Control Professional Company Representative 24-Jun-2005 12:19 PM Page: 1655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838569-8Report Type:Periodic Company Report #US_010564728 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Study Zyprexa (Olanzapine) PS 7.5 MG/DAY Life-Threatening Death Health Cartia Xt (Cartia Hospitalization - Diabetic Ketoacidosis Professional Xt) C Initial or Prolonged Dizziness K-Dur(Potassium Chloride) C Pepcid(Famotidine) C Enalapril C Propulsid (Cisapride) C Prozac (Fluoxetine Hydrochloride) C Glipizide C Folic Acid C Ferrous Sulfate C Novolin N(Insulin Human Injection, Isophane) C Hydroxyzine Pamoate C Diphenhydramine C Carbamazepine C Demadex (Torasemide) C Date:11/29/01ISR Number: 3838620-5Report Type:Periodic Company Report #US_000643357 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Study Olanzapine PS 15 MG/1 AT Life-Threatening Pneumonia Aspiration Health BEDTIME Hospitalization - Respiratory Arrest Professional Sertraline C Initial or Prolonged Trazodone C Aspirin C Vitamin B12 C Donepezil C Levothyroxine C Vitamin E C Docusate C Psyllium C Simethicone C Date:11/29/01ISR Number: 3838621-7Report Type:Periodic Company Report #US_000643391 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malignant Melanoma Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Health IN THE Professional EVENING Hytrin (Terazosin Hydrochloride) C Caltrate (Calcium Carbonate) C Multivitamin C Trimethoprim Sulfate C 24-Jun-2005 12:19 PM Page: 1656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838622-9Report Type:Periodic Company Report #US_000643521 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 20 MG/1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 2 DSG FORM Fluphenazine Hydrochloride SS 5 MG/3 DAY Atenolol C Sertraline Hydrochloride C Trihexyphenidyl C Date:11/29/01ISR Number: 3838623-0Report Type:Periodic Company Report #US_000439094 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Uterine Haemorrhage Study Olanzapine PS 12 MG Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG Ativan (Lorazepam) C Lo/Ovral C Multivitamin C Calcium C Tylenol (Paracetamol) C Ferrous Sulfate C Nasonex (Mometasone Furoate) C Date:11/29/01ISR Number: 3838624-2Report Type:Periodic Company Report #US_000439222 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Buccoglossal Syndrome Consumer Zyprexa (Olanzapine) PS 30 MG/ 1 DAY Initial or Prolonged Muscle Spasms Wellbutrin Nodding Of Head (Amfebutamone Overdose Hydrochloride) C Psychotic Disorder Haloperidol C Suicide Attempt Effexor (Venlafaxine Hydrochloride) C Date:11/29/01ISR Number: 3838626-6Report Type:Periodic Company Report #US_000440142 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Zyprexa (Olanzapine) PS 5 MG/ 1 AT Initial or Prolonged Suicide Attempt Health BEDTIME Professional Ambien (Zolpidem Tartrate) C Trazodone C Celexa (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 1657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838627-8Report Type:Periodic Company Report #US_000440393 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Study Olanzapine PS 2.5 MG AT Hospitalization - Body Temperature Health BEDTIME Initial or Prolonged Increased Professional Aspirin C Disability Brain Herniation Beclomethasone C Cerebrovascular Accident Metoprolol C Coma Trazodone C Dyspnoea Albuterol C Haemorrhage Intracranial Ibuprofen C Hypertension Loss Of Consciousness Pain Personality Disorder Psychosexual Disorder Date:11/29/01ISR Number: 3838628-XReport Type:Periodic Company Report #US_000541034 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperemesis Gravidarum Study Olanzapine PS 10 MG/ AT Initial or Prolonged Health BEDTIME Professional Zoloft (Sertraline Hydrochloride) C Proventil Inhaler (Salbutamol) C Date:11/29/01ISR Number: 3838629-1Report Type:Periodic Company Report #US_000541050 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Study Olanzapine PS 25 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine Hydrochloride SS 60 MG/ 1 IN THE MORNING Prevacid (Lansoprazole) C Loestrin C Naprosyn (Naproxen) C Tylenol (Paracetamol) C Date:11/29/01ISR Number: 3838630-8Report Type:Periodic Company Report #US_000541223 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 20 MG/ 1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS Aspirin C Multivitamin And Mineral Supplement C 24-Jun-2005 12:19 PM Page: 1658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838631-XReport Type:Periodic Company Report #US_000541300 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS Initial or Prolonged Schizophrenia Health Professional Date:11/29/01ISR Number: 3838633-3Report Type:Periodic Company Report #US_000134838 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Urinary Tract Infection Health AT BEDTIME Professional Ativan (Lorazepam) C Precose (Acarbose) C Zoloft (Sertraline Hydrochloride) C Colace (Docusate Sodium) C Vicon-C C Clonidine C Aspirin (E.C.) (Acetylsalicylic Acid) C Date:11/29/01ISR Number: 3838634-5Report Type:Periodic Company Report #US_000235175 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Bipolar I Disorder Health BEDTIME Drug Dependence Professional Valium (Diazepam) C Suicidal Ideation Date:11/29/01ISR Number: 3838635-7Report Type:Periodic Company Report #US_000235274 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Olanzapine PS Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3838636-9Report Type:Periodic Company Report #US_000235906 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS Initial or Prolonged Suicide Attempt Health Paxil (Paroxetine Professional Hydrochloride) C Depakote (Valproate Semisodium) C Restoril (Temazepam) C Tofranil (Imipramine Hydrochloride) C Trazodone C Theo-Dur (Theophylline) C 24-Jun-2005 12:19 PM Page: 1659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hytrin (Terazosin Hydrochloride) C Synthroid (Levothyroxine Sodium) C Colace (Docusate Sodium) C Septra C Ditropan (Oxybutynin) C Detrol (Tolterodine) C Date:11/29/01ISR Number: 3838637-0Report Type:Periodic Company Report #US_000336710 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Suicidal Study Fluoxetine Health (Fluoxetine Professional Hydrochloride) PS 1 DSG FORM/1 AT BEDTIME Olanzapine SS 2 DSG FORM/1 AT BEDTIME Date:11/29/01ISR Number: 3838638-2Report Type:Periodic Company Report #US_000336957 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Study Olanzapine PS 20 MG/1 AT Initial or Prolonged Chronic Obstructive Health BEDTIME Pulmonary Disease Professional Influenza Schizophrenia, Paranoid Type Date:11/29/01ISR Number: 3838639-4Report Type:Periodic Company Report #US_000337022 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Study Zyprexa (Olanzapine) PS 2.5 MG/1 AT Hospitalization - Cardiac Failure Health BEDTIME Initial or Prolonged Congestive Professional No Study Drug SS Cellulitis Albuterol C Chronic Obstructive Aricept C Pulmonary Disease Artificial Tears C Dyspnoea Aspirin C Pneumonia Atrovent C Renal Failure Acute Furosemide C Respiratory Failure Lanoxin C Multivitamin C Norvasc (Amlodipine Besilate) C Insulin Novolin C Phoslo (Calcium Acetate) C Prinivil (Lisinopril) C Reguloid (Psyllium) C Trazodone C 24-Jun-2005 12:19 PM Page: 1660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin C C Vitamin E C Zoloft (Sertraline Hydrochloride) C Acetaminophen C Isordil (Isosorbide Dinitrate) C Insulin C Ferrous Sulfate C Colace (Docusate Sodium) C Cortisporin Cream C Hydrocortisone C Azmacort (Triamcinolone Acetonide) C Diltiazem C Famvir (Famciclovir) C Cardizem Cd (Diltiazem Hydrochloride) C Hydralazine C K-Dur (Potassium Chloride) C Zaroxolyn (Metolazone) C Epogen (Epoetin Alfa) C Prednisone C Prevacid (Lansoprazole) C Vicodin C Ativan (Lorazepam) C Kayexalate (Sodium Polystrene Sulfonate) C Glucagon C Lacydrin C Domeboro C Bactroban (Mupirocin) C Nystatin C Combivent C Ambien (Zolpidem Tartrate) C Bisacodyl C Pepcid (Famotidine) C Date:11/29/01ISR Number: 3838640-0Report Type:Periodic Company Report #US_000337893 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Health AT BEDTIME Professional Placebo SS 1 DSG FORM/1 AT BEDTIME Citalopram C Trazodone C Diclofenac C Folic Acid C 24-Jun-2005 12:19 PM Page: 1661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thiamine C Multivitamin C Hydroxyzine C Benzatropine C Carbamazepine C Haloperidol C Date:11/29/01ISR Number: 3838641-2Report Type:Periodic Company Report #US_000338200 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Neoplasm Study Olanzapine PS 2.5 MG AT Initial or Prolonged Diverticulum Intestinal Health BEDTIME Professional Felodipine C Isosorbide Dinitrate C Multivitamin C Metoprolol Tartrate C Aspirin C Acetaminophen C Lactulose C Date:11/29/01ISR Number: 3838642-4Report Type:Periodic Company Report #US_000338297 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Study Olanzapine PS 5 MG DAY Initial or Prolonged Health Glyburide C Professional Imdur (Isosorbide Mononitrate) C Vasotec (Enalapril Maleate) C Lopid (Gemfibrozil) C Celexa (Citalopram Hydrobromide) C Date:11/29/01ISR Number: 3838643-6Report Type:Periodic Company Report #US_001052182 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Olanzapine PS 20 MG/1 IN Initial or Prolonged Health THE EVENING Professional Verapamil C Synthroid (Levothyroxine Sodium) C Theophylline C Valproic Acid C Date:11/29/01ISR Number: 3838644-8Report Type:Periodic Company Report #US_001052186 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Olanzapine PS 2 DSG FORM/1 Initial or Prolonged Health DAY Professional Methotrexate C Folic Acid C Fosamax (Alendronate 24-Jun-2005 12:19 PM Page: 1662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Aricept (Donepezil Hydrochloride0 C Date:11/29/01ISR Number: 3838645-XReport Type:Periodic Company Report #US_001052500 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Open Fracture Study Olanzapine PS 1 DSG Initial or Prolonged Road Traffic Accident Health FORM/DAY Professional Placebo SS 1 DSG FORM/DAY Ambien (Zolpidem Tartrate) C Date:11/29/01ISR Number: 3838646-1Report Type:Periodic Company Report #US_001052581 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Olanzapine PS 5 MG/1 DAY Initial or Prolonged Health Exelon (Rivastigmine Professional Tartrate) C Evista (Raloxifene Hydrochloride) C Folic Acid C Vitamin C C Vitamin E C Multivitamin C Date:11/29/01ISR Number: 3838647-3Report Type:Periodic Company Report #US_001152728 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Zyprexa (Olanzapine) PS 20 MG/1 AT Loss Of Consciousness Professional BEDTIME Company Parnate Representative (Tranylcypromide Sulfate) C Estrogen Nos C Piroxicam C Levothyyroxine C Date:11/29/01ISR Number: 3838648-5Report Type:Periodic Company Report #US_001152744 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine PS Initial or Prolonged Agitation Health Aspirin C Disability Confusional State Professional Coumadin (Warfarin Sodium) C Date:11/29/01ISR Number: 3838649-7Report Type:Periodic Company Report #US_001152751 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Blood Potassium Increased Initial or Prolonged Ketoacidosis 24-Jun-2005 12:19 PM Page: 1663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Sedation Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 32.5 MG/DAY Professional Klonopin (Clonazepam) C Sonata(Zaleplon) C Date:11/29/01ISR Number: 3838650-3Report Type:Periodic Company Report #US_001052458 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Chondromatosis Health BEDTIME Other Professional Paxil (Paroxetine Hydrochloride) C Date:11/29/01ISR Number: 3838651-5Report Type:Periodic Company Report #US_001153198 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Study Olanzapine PS 18 MG/1 IN Initial or Prolonged Health THE EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG/1 IN THE EVENING Date:11/29/01ISR Number: 3838652-7Report Type:Periodic Company Report #US_001153287 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Zyprexa (Olanzapine) PS Initial or Prolonged Weight Increased Professional Company Representative Date:11/29/01ISR Number: 3838653-9Report Type:Periodic Company Report #EWC010225441 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS 255 MG/MONTH Initial or Prolonged Psychotic Disorder Health Ativan (Lorazepam) C Professional Date:11/29/01ISR Number: 3838654-0Report Type:Periodic Company Report #EWC010225718 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 300 MG/MONTH Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838655-2Report Type:Periodic Company Report #EWC010426228 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 255 MG/MONTH Initial or Prolonged Health Mellaril Professional (Thioridazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Desyrel (Trazodone Hydrochloride) C Wellbutrin (Amfebutamone Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Procardia Xl (Nifedipine) C Multivitamins C Vitamin E C Date:11/29/01ISR Number: 3838656-4Report Type:Periodic Company Report #EWC010526918 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 255 MG/MONTH Initial or Prolonged Health Zestril (Lisinopril) C Professional Provachol C Prolixin Decanoate (Fluphenazine Decanoate) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3838657-6Report Type:Periodic Company Report #EWC010727699 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 300 MG/OTHER Initial or Prolonged Health Norvasc (Amlodipine Professional Besilate) C Synthroid (Levothyroxine Sodium) C Zocor (Simvastatin) C Ambien (Zolpidem Tartrate) C Date:11/29/01ISR Number: 3838658-8Report Type:Periodic Company Report #EWC010827875 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 300 MG/OTHER Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3838659-XReport Type:Periodic Company Report #EWC010827973 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 200 MG/ Initial or Prolonged Health EVERYOTHER Professional WEEK Ativan (Lorazepam) C Restoril (Temazepam) C Prozac (Fluoxetine Hydrochloride) C Date:11/29/01ISR Number: 3838660-6Report Type:Periodic Company Report #EWC010827980 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Study Olanzapine PS 300 MG/ 1 Initial or Prolonged Health OTHER Professional Date:11/29/01ISR Number: 3839484-6Report Type:Periodic Company Report #US_010464338 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Zyprexa PS 20 MG/DAY Initial or Prolonged Weight Increased Professional Prozac (Fluoxetine Hydrochloride) SS Restoril (Temazepam) C Tegretol (Carbamazepine) C Neurontin (Gabapentin) C Date:11/29/01ISR Number: 3839486-XReport Type:Periodic Company Report #US_010464358 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Olanzapine PS 2.5 MG DAY Hospitalization - Health Aricept (Donepezil Initial or Prolonged Professional Hydrochloride) C Flonase (Fluticasone Propionate) C Combivent C Isosorbide C Alprazolam C Haldol (Haloperidol) C Date:11/29/01ISR Number: 3839491-3Report Type:Periodic Company Report #US_010464422 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Olanzapine PS 2.5 MG DAY Initial or Prolonged Health Multivitamin C Professional Cyanocobalamin C Zinc Oxide C 24-Jun-2005 12:19 PM Page: 1666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839493-7Report Type:Periodic Company Report #US_010464478 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Wellbutrin Sr Professional (Amfebutamone Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3839495-0Report Type:Periodic Company Report #US_010464502 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa (Olanzapine) PS 50 MG/DAY Initial or Prolonged Tachycardia Professional Depakote (Valproate Company Semisodium) C Representative Date:11/29/01ISR Number: 3839496-2Report Type:Periodic Company Report #US_010464109 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 15 MG/AT Initial or Prolonged Suicidal Ideation Health BEDTIME Professional Date:11/29/01ISR Number: 3839497-4Report Type:Periodic Company Report #US_010464011 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3839502-5Report Type:Periodic Company Report #US_010464018 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Study Olanzapine PS 10 MG/AT Initial or Prolonged Health BEDTIME Professional Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3839503-7Report Type:Periodic Company Report #US_010463673 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine(Fluoxetin Professional e Hydrochloride) SS 50 MG DAY Lorazepam C Lipitor (Atorvastatin) C Naprosyn (Naproxen) C Imitrex (Sumatriptan 24-Jun-2005 12:19 PM Page: 1667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Succinate) C Date:11/29/01ISR Number: 3839504-9Report Type:Periodic Company Report #US_010463717 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Olanzapine PS 6 MG DAY Initial or Prolonged Hyperglycaemia Health Fluoxetine Vertigo Positional Professional (Fluoxetine Vision Blurred Hydrochloride) SS 25 MG DAY Aspirin C Acetaminophen C Ibuprofen C Hydrochlorothiazide C Rhinocort (Budesonide) C Midrin C Date:11/29/01ISR Number: 3839507-4Report Type:Periodic Company Report #US_000949900 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Zyprexa (Olanzapine) PS 10 MG/DAY Fall Professional Ultram (Tramadol Grand Mal Convulsion Company Hydrochloride) C Loss Of Consciousness Representative Synthroid (Levothyroxine Sodium) C Wellbutrin Sr (Amfebutamone Hydrochloride) C Date:11/29/01ISR Number: 3839509-8Report Type:Periodic Company Report #US_010362997 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 5 MG/AT Initial or Prolonged Health BEDTIME Professional Lipitor (Atorvastatin) C Zestril (Lisinopril) C Glucophage (Metformin Hydrochloride) C Lithium C Ritalin (Methylphenidate Hydrochloride) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3839511-6Report Type:Periodic Company Report #US_000950662 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alcohol Increased Health Zyprexa (Olanzapine) PS 10 MG/DAY 2 MON Initial or Prolonged Diabetic Ketoacidosis Professional Haldol Depot Hyperglycaemia (Haloperidol Weight Decreased Decanoate) C 24-Jun-2005 12:19 PM Page: 1668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glucose C Date:11/29/01ISR Number: 3839512-8Report Type:Periodic Company Report #US_000950710 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa (Olanzapine) PS 5 MG/1 AT Initial or Prolonged Anger Health BEDTIME Nervousness Professional Zoloft (Sertraline Somnolence Hydrochloride) C Adderall C Levothroid (Levothyroxine Sodium) C Depakote (Valproate Semisodium) C Amoxil (Amoxicillin Trihydrate) C Date:11/29/01ISR Number: 3839514-1Report Type:Periodic Company Report #US_000950743 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3839515-3Report Type:Periodic Company Report #US_000950768 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Study Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Initial or Prolonged Health Cardizem Cd Professional (Diltiazem Hydrochloride) C Docusate Sodium C Tylenol Extra Strength (Paracetamol) C Ensure Plus C Multivitamins Nos (Multivitamins Nos) C Aricept (Donepezil Hydrochloride) C Date:11/29/01ISR Number: 3839516-5Report Type:Periodic Company Report #US_001050776 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 5 MG/1 AT Initial or Prolonged Syndrome Professional BEDTIME Company Effexor (Venlafaxine Representative Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839517-7Report Type:Periodic Company Report #US_001050777 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Zyprexa (Olanzapine) PS 10 MG/DAY 7 MON Initial or Prolonged Intentional Misuse Effexor (Venlafaxine Vomiting Hydrochloride) C Weight Increased Date:11/29/01ISR Number: 3839519-0Report Type:Periodic Company Report #US_001050921 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS 6 MG/1 DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG/1 DAY Chloral Hydrate C Date:11/29/01ISR Number: 3839523-2Report Type:Periodic Company Report #US_001050938 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG/1 DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG/1 DAY Tylenol (Paracetamol) C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3839531-1Report Type:Periodic Company Report #US_001050987 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Study Olanzapine PS 2 DSG Life-Threatening Myocardial Ischaemia Health FORM/DAY Hospitalization - Sepsis Professional Glyburide C Initial or Prolonged Glucophage C Proscar C Procardia C Plavix C Vitamin B12 C Selenium C Vitamin B12 C Vitamin E C Betacarotene C Garlic C Multivitamin C Date:11/29/01ISR Number: 3839540-2Report Type:Periodic Company Report #US_001051008 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 10MG/ 1 DAY Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839546-3Report Type:Periodic Company Report #US_001051077 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Laboratory Test Abnormal Professional Date:11/29/01ISR Number: 3839556-6Report Type:Periodic Company Report #US_010463723 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Depakote (Valproate Professional Semisodium) C Topamax (Topiramate) C Date:11/29/01ISR Number: 3839563-3Report Type:Periodic Company Report #US_010463835 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Literature Zyprexa (Olanzapine) PS UNKNOWN 1 WK Initial or Prolonged Syndrome Health Paroxetine C Professional Depakote (Valproate Company Semisodium) C Representative Risperdal (Risperidone) C Lorazepam C Levodopa-Carbidopa C Selegiline C Date:11/29/01ISR Number: 3839582-7Report Type:Periodic Company Report #US_010463571 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine PS 2.5 MG AT Initial or Prolonged Burns Second Degree Health BEDTIME Dehydration Professional Aspirin C Hostility Macrobid C Neurogenic Bladder Bactrim Ds C Urinary Tract Infection Date:11/29/01ISR Number: 3839587-6Report Type:Periodic Company Report #US_010463482 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 10MG / DAY Initial or Prolonged Confusional State Health Nalvadex C Professional Ativan C Date:11/29/01ISR Number: 3839592-XReport Type:Periodic Company Report #US_010463436 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG AT Initial or Prolonged Psychotic Disorder Health BEDTIME Professional Placebo SS 50 MG / AT BEDTIME 24-Jun-2005 12:19 PM Page: 1671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839595-5Report Type:Periodic Company Report #US_010463438 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Olanzapine PS ORAL 12 MG PO DAY Initial or Prolonged Health Placebo SS Professional Ativan C Date:11/29/01ISR Number: 3839597-9Report Type:Periodic Company Report #US_010463439 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Study Olanzapine PS 2 DSG FORM AT Initial or Prolonged Health BEDTIME Professional Stelazine C Date:11/29/01ISR Number: 3839598-0Report Type:Periodic Company Report #US_010463302 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Coma Health Zyprexa PS UNKNOWN Professional Company Representative Date:11/29/01ISR Number: 3839601-8Report Type:Periodic Company Report #US_010564833 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ovarian Cancer Study Olanzapine PS 5 MG/IN THE Hospitalization - Health EVENING Initial or Prolonged Professional Disability Date:11/29/01ISR Number: 3839602-XReport Type:Periodic Company Report #US_010564928 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 15 MG/DAY Professional Date:11/29/01ISR Number: 3839603-1Report Type:Periodic Company Report #US_010565000 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Literature Olanzapine PS 10 MG/1 DAY Initial or Prolonged Diabetes Mellitus Health Fluoxetine Other Sexual Dysfunction Professional Hydrochloride SS Suicidal Ideation Mirtazapine C Suicide Attempt Benztropine C Weight Decreased Temazepam C Weight Increased 24-Jun-2005 12:19 PM Page: 1672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839605-5Report Type:Periodic Company Report #US_010565039 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Olanzapine PS 15 MG/1 DAY Health Divalproex Sodium C Professional Sertraline C Propranolol C Date:11/29/01ISR Number: 3839608-0Report Type:Periodic Company Report #US_010565043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa Initial or Prolonged Intentional Misuse Professional (Olanzapine) PS 190 MG/DAY Company Representative Date:11/29/01ISR Number: 3839611-0Report Type:Periodic Company Report #US_010464165 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Study Olanzapine PS 2 DSG Initial or Prolonged Health FORM/DAY Disability Professional Paxil (Paroxetine Hydrochloride) C Valium (Diazepam) C Depo Provera (Medroxyprogesterone Acetate) C Date:11/29/01ISR Number: 3839612-2Report Type:Periodic Company Report #US_010464178 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 8 DSG Initial or Prolonged Health FORM/DAY Professional Olanzapine SS 10 MG/DAY Ativan (Lorazepam) C Date:11/29/01ISR Number: 3839613-4Report Type:Periodic Company Report #US_010464254 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Zyprexa Professional (Olanzapine) PS 15 MG/DAY Company Valium (Diazepam) C Representative Date:11/29/01ISR Number: 3839614-6Report Type:Periodic Company Report #US_010464259 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS Initial or Prolonged Coma Professional Depressed Level Of Company Consciousness Representative 24-Jun-2005 12:19 PM Page: 1673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839615-8Report Type:Periodic Company Report #US_010464300 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Disability Professional Date:11/29/01ISR Number: 3839623-7Report Type:Periodic Company Report #US_010566539 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Quetiapine PS 300 MG/DAY Initial or Prolonged Health Quetiapine SS 400 MG/DAY Professional Olanzapine SS 15 MG/IN THE EVENING Valium (Diazepam) C Date:11/29/01ISR Number: 3839626-2Report Type:Periodic Company Report #US_010566664 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Zyprexa (Olanzapine) PS 15 MG/DAY Hospitalization - Phosphokinase Increased Professional Lorazepam C Initial or Prolonged Pyrexia Company Other Representative Date:11/29/01ISR Number: 3839628-6Report Type:Periodic Company Report #US_010566708 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Study Risperidone PS 1 DSG FORM Initial or Prolonged Health DAY Professional Olanzapine SS 3.75 MG DAY Hyoscyamine C Dorzolamide C Sertraline C Furosemide C Date:11/29/01ISR Number: 3839629-8Report Type:Periodic Company Report #US_010566063 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 10 MG/AT Initial or Prolonged Health BEDTIME Other Professional Gabapentin C Synthroid (Levothyroxine Sodium) C Propranolol C Chlorothiazide C Mysoline (Primidone) C Docusate Sodium C Trazodone C Asa (Acetylsalicylic Acid) C Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 1674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin Humulin 70/30 C Benazepril C Tylenol (Paracetamol) C Ativan (Lorazepam) C Nicorette (Nicotine Resin) C Klonopin (Clonazepam) C Benadryl (Diphenhydramine Hydrochloride) C Date:11/29/01ISR Number: 3839637-7Report Type:Periodic Company Report #US_010566126 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa (Olanzapine) PS 7.5 MG/1 DAY Initial or Prolonged Phosphokinase Increased Professional Depakote (Valproate Confusional State Semisodium) C Delirium Metoprolol C Hyperhidrosis Tachycardia Tremor White Blood Cell Count Increased Date:11/29/01ISR Number: 3839639-0Report Type:Periodic Company Report #US_010566144 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 7.5 MG/DAY Initial or Prolonged Syndrome Professional Norvasc (Amlodipine Besilate) C Multivitamin C Date:11/29/01ISR Number: 3839640-7Report Type:Periodic Company Report #US_010566146 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Study Olanzapine PS 10 MG/AT Initial or Prolonged Nausea Health BEDTIME Sedation Professional Oxybutynin C Ceftazidime C Date:11/29/01ISR Number: 3839641-9Report Type:Periodic Company Report #US_010565957 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Literature Olanzapine PS 7.5 MG/1 DAY Priapism Health Gabapentin C Psychotic Disorder Professional Oxazepam C Fluvoxamine C Risperidone C 24-Jun-2005 12:19 PM Page: 1675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839642-0Report Type:Periodic Company Report #US_010565805 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 3 DSG Initial or Prolonged Health FORM/DAY Professional Placebo SS 3 DSG FORM/DAY Ativan (Lorazepam) C Ortho Cyclen C Date:11/29/01ISR Number: 3839643-2Report Type:Periodic Company Report #US_010565817 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Olanzapine PS 10 MG/DAY Initial or Prolonged Professional Neurontin Disability (Gabapentin) C Date:11/29/01ISR Number: 3839644-4Report Type:Periodic Company Report #EWC010828116 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS Eli Lilly And Initial or Prolonged Health Company 200 MG/2 WEEK Professional Date:11/29/01ISR Number: 3839645-6Report Type:Periodic Company Report #EWC010928389 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Study Olanzapine PS 300 MG/EVERY Initial or Prolonged Health OTHER WEEK Professional Date:11/29/01ISR Number: 3839646-8Report Type:Periodic Company Report #US94084090A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Study Zyprexa(Olanzanpine) PS 20/MG/ 1 DAY Hospitalization - Diabetic Ketoacidosis Health Ativan (Lorazepam) C Initial or Prolonged Ketosis Professional Polydipsia Polyuria Weight Decreased Date:11/29/01ISR Number: 3839647-XReport Type:Periodic Company Report #US_010463113 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Consumer Zyprexa (Olanzapine) PS Eli Lilly And Initial or Prolonged Dizziness Company 20 MG/DAY 5 MON Ear Pain Quetiapine C Eli Lilly 20 MG/DAY 5 MON Localised Oedema Quetiapine C Oral Pain Schizophreniform Disorder Weight Decreased 24-Jun-2005 12:19 PM Page: 1676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839648-1Report Type:Periodic Company Report #US97054927A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa(Olanzanpine) PS 300 MG Initial or Prolonged Consciousness Professional Prozac(Fluoxetine Hypersomnia Hydrochloride) SS 1000 MG Overdose Phenobarbital C Dilantin (Phenytoin Sodium) C Alcohol C Date:11/29/01ISR Number: 3839655-9Report Type:Periodic Company Report #US98030667A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Zyprexa(Olanzapine) PS 5 MG Initial or Prolonged Agitation Consumer Hostility Paranoia Psychotic Disorder Date:11/29/01ISR Number: 3839657-2Report Type:Periodic Company Report #US_000133673 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Study Zyprexa(Olanzapine) PS 7 MG/QAM DAY Hospitalization - Health Prevacid Initial or Prolonged Professional (Lansoprazole) C Metamucil (Psyllium Hydrophillic Mucilloid) C Regulcid C Multivitamin C Timopotic (Timolol Maleate) C Trazadone C Trusopt (Dorzalamide Hydrochloride) C Lac-Hydrin (Ammonium Lactate) C Two-Cal Hn C Aricept (Donepezil Hydrochloride) C Buspar (Buspirone Hydrochloride) C Furosemide C K-Dur (Potassium Chloride) C Lanoxin (Dygoxin) C Acetaminophen C Lortab Elixir C Ativan (Lorazepam) C Levaquin (Levofloxacin) C Guaifenesin C Coumadin (Warfarin Sodium) C Imodium (Loperamide Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxygen C Date:11/29/01ISR Number: 3839660-2Report Type:Periodic Company Report #US_000134224 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Study Olanzapine PS 7.5 MG Life-Threatening Health Lasix (Furosemide) C Hospitalization - Professional Lotensin (Benazepril Initial or Prolonged Hydrochloride) C Vitamin E C Klor-Con (Potassium Chloride) C Date:11/29/01ISR Number: 3839662-6Report Type:Periodic Company Report #US_000134397 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Olanzapine PS 15 MG/1 AT Initial or Prolonged Paranoia Health BEDTIME Professional Placebo SS 2 MG/DAY Tylenol W/Codeine No. 3 C Nicotine C Propranolol C Motrin (Ibuprofen) C Ciprofloxacin Hydrochloride C Folic Acid C Cogentin (Benzatropine Mesilate) C Metronidazole C Date:11/29/01ISR Number: 3839664-XReport Type:Periodic Company Report #US_000134550 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 17.5 MG/1 DAY Initial or Prolonged Health Zoloft (Sertraline Professional Hydrochloride) C Date:11/29/01ISR Number: 3839666-3Report Type:Periodic Company Report #US_000948895 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Study Olanzapine PS 5 MG/1 DAY Initial or Prolonged Gait Disturbance Health Zoloft (Sertraline Posture Abnormal Professional Hydrochloride) C Hytrin (Terazosin Hydrochloride) C Aricept (Donepezil Hydrochloride) C Colace (Docusate Sodium) C 24-Jun-2005 12:19 PM Page: 1678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839669-9Report Type:Periodic Company Report #US_000949040 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Homicidal Ideation Study Olanzapine PS 20 MG/1 AT Initial or Prolonged Psychotic Disorder Health BEDTIME Professional Fluticasone C Ipratropium Bromide C Albuterol C Beclometasone C Tegretol (Carbamazepine) C Acetaminophen C Trazodone C Hydroxyzine C Date:11/29/01ISR Number: 3839671-7Report Type:Periodic Company Report #US_000949240 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Study Olanzapine PS 20 MG Hospitalization - Hyperglycaemia Health Effexor (Venlafaxine Initial or Prolonged Renal Failure Acute Professional Hydrochloride) C Lorazepam C Glucotrol Xl (Glipizide) C Gemfibrozil C Glucophage (Metformin Hydrochloride) C Date:11/29/01ISR Number: 3839674-2Report Type:Periodic Company Report #US_000949295 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa (Olanzapine) PS 375 MG Initial or Prolonged Intentional Misuse Professional Zoloft (Sertraline Somnolence Hydrochloride) C Suicide Attempt Date:11/29/01ISR Number: 3839675-4Report Type:Periodic Company Report #US_000949398 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 20 MG/1 DAY Initial or Prolonged Health Citracal (Calcium Professional Citrate) C Premarin (Estrogens Conjugated) C Allegra (Fexofenadine Hydrochloride) C Lorazepam C Ranitidine C Docusate C Valproic Acid C Naproxen C 24-Jun-2005 12:19 PM Page: 1679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3839679-1Report Type:Periodic Company Report #US_000949660 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Study Olanzapine PS 6 MG/1 AT Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 AT BEDTIME Date:11/29/01ISR Number: 3839681-XReport Type:Periodic Company Report #US_000949687 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa (Olanzapine) PS 10 MG/1 AT Initial or Prolonged Increased Professional BEDTIME Aspartate Company Haloperidol C Aminotransferase Representative Lithium Carbonate C Increased Clonazepam C Breath Sounds Decreased Cogentin Dizziness (Benzatropine Neuroleptic Malignant Mesilate) C Syndrome Date:11/29/01ISR Number: 3839683-3Report Type:Periodic Company Report #US_000949804 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS Initial or Prolonged Health Placebo SS Professional Lorazepam C Temazepam C Centrum C Vitamin C C Date:11/29/01ISR Number: 3839684-5Report Type:Periodic Company Report #US_000949829 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 15 MG/1 IN Initial or Prolonged Health THE EVENING Professional Oscal (Calcium Carbonate) C Vitamin E C Vitamin B6 C Benadryl (Diphenhydramine Hydrochloride) C Tegretol (Carbamazepine) C Date:11/29/01ISR Number: 3839685-7Report Type:Periodic Company Report #US_000847602 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Suicidal Ideation Study Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 1680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Olanzapine PS 10 MG/AT BEDTIME Lisinopril C Glucophage (Metformin Hydrochloride) C Glipizide C Lithium C Date:11/29/01ISR Number: 3839686-9Report Type:Periodic Company Report #US_000847640 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa (Olanzapine) PS 20 MG/DAY 42 MON Initial or Prolonged Diabetes Mellitus Lithium C Pollakiuria Tegretol (Carbamazepine) C Klonopin (Clonazepam) C Mellaril (Thioridazine Hydrochloride) C Synthroid (Levothyroxine Sodium) C Prevacid (Lansoprazole) C Claritin (Loratadine) C Date:11/29/01ISR Number: 3839687-0Report Type:Periodic Company Report #US_000847800 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Study Olanzapine PS 2.5 MG/1 AT Initial or Prolonged Health BEDTIME Professional Lorazepam C Trazodone C Vitamin E C Paxil (Paroxetine Hydrochloride) C Monopril (Fosinopril Sodium) C Norvasc (Amlodipine Besilate) C Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3839688-2Report Type:Periodic Company Report #US_000847873 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Study Olanzapine PS Health Advil (Ibuprofen) C Professional Vitamin B12 C 24-Jun-2005 12:19 PM Page: 1681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prempro C Vitamin E C Multivitamin C Vitamin C C Calcium Magnesium Zinc C Aspirin C Folic Acid C Date:11/29/01ISR Number: 3839690-0Report Type:Periodic Company Report #US_000847893 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Risperidone C Professional Benzoyl Peroxide C Doxycycline C Date:11/29/01ISR Number: 3839692-4Report Type:Periodic Company Report #US_000848421 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 6 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG/1 AT BEDTIME Ativan (Lorazepam) C Date:11/29/01ISR Number: 3839696-1Report Type:Periodic Company Report #US_000948692 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Zyprexa (Olanzapine) PS 15 MG/DAY Congestive Professional Prozac (Fluoxetine Libido Decreased Hydrochloride) SS 20 MG/DAY Valium (Diazepam) C Lamictal (Lamotrigine) C Ziac C Date:11/29/01ISR Number: 3839698-5Report Type:Periodic Company Report #US_000948765 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Study Olanzapine PS 15 MG/1 AT Hospitalization - Dyspnoea Health BEDTIME Initial or Prolonged Hyperglycaemia Professional Novolin (Insulin Lung Neoplasm Malignant Human Injection, Respiratory Arrest Isophane) C Diclofenac C Trazodone C 24-Jun-2005 12:19 PM Page: 1682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3842069-9Report Type:Periodic Company Report #US_010260698 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Company Representative Date:11/29/01ISR Number: 3842070-5Report Type:Periodic Company Report #US_010260739 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Professional Dilantin (Phenytoin Company Sodium) C Representative Date:11/29/01ISR Number: 3842071-7Report Type:Periodic Company Report #US_010260025 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Zyprexa (Olanzapine) PS 25 MG/DAY 2 YR Initial or Prolonged Overdose Haldol (Haloperidol) C Polydipsia Polyuria Vomiting Date:11/29/01ISR Number: 3842072-9Report Type:Periodic Company Report #US_010260051 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Prozac (Fluoxetine Initial or Prolonged Professional Hydrochloride) PS 10 MG/2 DAY Company Zyprexa (Olanzapine) SS 2.5 MG/ IN Representative THE EVENING Date:11/29/01ISR Number: 3842073-0Report Type:Periodic Company Report #US_010260056 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 20 MG/DAY Initial or Prolonged Health Clonazepam C Professional Synthroid (Levothyroxine Sodium) C Date:11/29/01ISR Number: 3842074-2Report Type:Periodic Company Report #US_010260168 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Study Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Health Temazepam C Professional Darvocet-N C Ventolin (Salbutamol) C 24-Jun-2005 12:19 PM Page: 1683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3842075-4Report Type:Periodic Company Report #US_010260182 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Health Paxil (Paroxetine Professional Hydrochloride) C Lactulose C Pepcid Ac (Famotidine) C Ibuprofen C Pseudoephedrine C Meclizine C Acetaminophen C Artificial Tears C Bisacodyl C Lorazepam C Date:11/29/01ISR Number: 3842076-6Report Type:Periodic Company Report #US_010260203 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 6 MG AT Initial or Prolonged Pneumonia Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG AT BEDTIME Caltrate (Calcium Carbonate) C Advil (Ibuprofen) C Lorazepam C Levoxacin (Levofloxacin) C Trazodil (Trazodone Hydrochloride) C Date:11/29/01ISR Number: 3842077-8Report Type:Periodic Company Report #US_010260220 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG DAY Initial or Prolonged Drug Abuser Health Fluoxetine(Fluoxetin Paranoia Professional e Hydrochloride) SS 25 MG DAY Suicidal Ideation Lorazepam C Date:11/29/01ISR Number: 3842084-5Report Type:Periodic Company Report #US_010260324 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS 20 MG/DAY Initial or Prolonged Health Tagamet (Cimetidine) C Professional Depakote (Valproate Semisodium) C Norvasc (Amlodipine Besilate) C 24-Jun-2005 12:19 PM Page: 1684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3842085-7Report Type:Periodic Company Report #US_001052122 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Increased Professional Neurontin Arthralgia (Gabapentin) C Aspartate Celexa (Citalopram Aminotransferase Hydrobromide) C Increased Ambien (Zolpidem Food Craving Tartrate) C Headache Pyrexia Date:11/29/01ISR Number: 3842086-9Report Type:Periodic Company Report #US_001052128 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 12 MG/1 AT Initial or Prolonged Depressed Mood Health BEDTIME Professional Fluoxetine Hydrochloride SS 25 MG/1 AT BEDTIME Serax (Oxazepam) C Multivitamin C Ativan (Lorazepam) C Date:11/29/01ISR Number: 3842087-0Report Type:Periodic Company Report #US_001052017 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS Initial or Prolonged Health Placebo SS Professional Tylenol (Paracetamol) C Motrin (Ibuprofen) C Lorazepam C Date:11/29/01ISR Number: 3842088-2Report Type:Periodic Company Report #US_001052076 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Health Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Blood Sodium Decreased Professional Other Ketoacidosis Company Overdose Representative Date:11/29/01ISR Number: 3842089-4Report Type:Periodic Company Report #US_001051870 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa (Olanzapine) PS 2.5 MG/1 DAY 49 WK Initial or Prolonged Health Donepezil Professional Hydrochloride C Multivitamins C Influenza Virus Vaccine C Phosphatidyl Serine C 24-Jun-2005 12:19 PM Page: 1685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin C Date:11/29/01ISR Number: 3842090-0Report Type:Periodic Company Report #US_001051889 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 5 MG/DAY Professional Company Representative Date:11/29/01ISR Number: 3842091-2Report Type:Periodic Company Report #US_001052318 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Study Olanzapine PS 2.5 MG/1 IN Health THE EVENING 65 DAY Professional Coumadin (Warfarin Sodium) C Lanoxin (Digoxin) C Date:11/29/01ISR Number: 3842092-4Report Type:Periodic Company Report #US_001052350 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Study Olanzapine PS 2.5 MG/1 IN Initial or Prolonged Health THE EVENING Professional Aspirin C Lotensin (Benazepril Hydrochloride) C Glucophage (Metformin Hydrochloride) C Norvasc (Amlodipine Besilate) C Paxil (Paroxetine Hydrochloride) C Date:11/29/01ISR Number: 3842093-6Report Type:Periodic Company Report #US_001052354 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Olanzapine PS 10 MG/1 DAY Initial or Prolonged Agitation Health Clozapine C Delusion Professional Divalproex Sodium C Paranoia Date:11/29/01ISR Number: 3842094-8Report Type:Periodic Company Report #US_001052161 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Prolapse Study Olanzapine PS 15 MG/1 DAY Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3842095-XReport Type:Periodic Company Report #US_010769382 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS Initial or Prolonged Hyperglycaemia Professional Date:11/29/01ISR Number: 3842096-1Report Type:Periodic Company Report #US_010769385 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Hyperglycaemia Professional Lithium C Other Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3842097-3Report Type:Periodic Company Report #US_010769399 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Tachycardia Health Zyprexa (Olanzapine) PS Professional Company Representative Date:11/29/01ISR Number: 3842098-5Report Type:Periodic Company Report #US_010769496 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 12 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG AT BEDTIME Synthroid (Levothyroxine Sodium) C Robitussin (Guaifenesin) C Comtrex C Lorazepam C Tylenol (Paracetamol) C Date:11/29/01ISR Number: 3842099-7Report Type:Periodic Company Report #US_010769503 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS Initial or Prolonged Health Citalopram C Professional Clonazepam C Metformin C Lisinopril C Isotretinoin C Albuterol Sulfate C Albuterol C Salmeterol Xinafoate C 24-Jun-2005 12:19 PM Page: 1687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluticasone Propionate C Triamcinolone Acetonide C Date:11/29/01ISR Number: 3842100-0Report Type:Periodic Company Report #US_010769079 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 5 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG/AT BEDTIME Vitamin E C Vitamin C C Aspirin C Tums C Estrace (Estradiol) C Date:11/29/01ISR Number: 3842101-2Report Type:Periodic Company Report #US_010768988 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Consumer Zyprexa (Olanzapine) PS 15 MG/DAY 3 MON Insomnia Prozac (Fluoxetine Loss Of Consciousness Hydrochloride) SS Road Traffic Accident Lithium C Thinking Abnormal Thirst Weight Increased Date:11/29/01ISR Number: 3842102-4Report Type:Periodic Company Report #US_010768954 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Cell Carcinoma Study Olanzapine PS 10 MG/DAY Initial or Prolonged Stage Unspecified Health Professional Date:11/29/01ISR Number: 3842103-6Report Type:Periodic Company Report #US_010768865 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Study Olanzapine PS 20 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 80 MG/IN THE MORNING 24-Jun-2005 12:19 PM Page: 1688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3842104-8Report Type:Periodic Company Report #US_010768905 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Olanzapine PS 12 MG DAY Initial or Prolonged Congestive Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 75 MG AY Multivitamin C Vasotec (Enalapril Maleate) C Glucophage (Metformin Hydrochloride) C Glyburide C Prilosec (Omeprazole) C Actos (Pioglitazone) C Lasix (Furosemide) C Spironolactone C Zocor (Simvastatin) C Precose(Acarbose) C Premarin (Estrogens Conjugated) C Hyoscyamine C Glucovance C Motrin (Ibuprofen) C Prevacid (Lansoprazole) C Date:11/29/01ISR Number: 3842105-XReport Type:Periodic Company Report #US_010769790 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 5 MG/DAY Syndrome Professional Zoloft (Sertraline Company Hydrochloride) C Representative Date:11/29/01ISR Number: 3842106-1Report Type:Periodic Company Report #US_010769791 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 20 MG/DAY Professional Date:11/29/01ISR Number: 3842107-3Report Type:Periodic Company Report #US_010769794 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Professional Company Representative 24-Jun-2005 12:19 PM Page: 1689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3842108-5Report Type:Periodic Company Report #US-010769680 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atelectasis Consumer Zyprexa (Olanzapine) PS 5 MG/DAY 6 WK Initial or Prolonged Chest Wall Pain Prozac (Fluoxetine Oedema Peripheral Hydrochloride) SS 80 MG/DAY 13 YR Hydrochlorothiazide With Triamterene C Date:11/29/01ISR Number: 3842109-7Report Type:Periodic Company Report #US_010769705 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Study Olanzapine PS 10 MG/DAY Initial or Prolonged Inversion Health Toradol (Ketorolac Professional Tromethamine) C Date:11/29/01ISR Number: 3842110-3Report Type:Periodic Company Report #US_010769751 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Consumer Zyprexa (Olanzapine) PS 25 MG/DAY Initial or Prolonged Prescribed Overdose Restlessness Date:11/29/01ISR Number: 3842111-5Report Type:Periodic Company Report #US_010769545 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 10 MG/1 DAY Petit Mal Epilepsy Professional Clonazepam C Date:11/29/01ISR Number: 3842112-7Report Type:Periodic Company Report #US_010769174 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa (Olanzapine) PS 50 MG/DAY Initial or Prolonged Hallucination Professional Overdose Company Somnolence Representative Date:11/29/01ISR Number: 3842113-9Report Type:Periodic Company Report #US_010769210 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Loss Of Consciousness Klonopin Memory Impairment (Clonazepam) C Desyrel (Trazodone Hydrochloride) C Detrol (Tolterodine L-Tartrate) C Ativan (Lorazepam) C Depakote (Valproate Semisodium) C Bipolar Disorder C 24-Jun-2005 12:19 PM Page: 1690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3842114-0Report Type:Periodic Company Report #US_010769256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Zyprexa (Olanzapine) PS Syncope Date:11/29/01ISR Number: 3842115-2Report Type:Periodic Company Report #US_980503406 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Study Olanzapine PS Initial or Prolonged Mood Swings Health Depakote (Valproate Professional Semisodium) C Date:11/29/01ISR Number: 3842116-4Report Type:Periodic Company Report #US_980504135 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Study Olanzapine PS 10 MG/ DAY Initial or Prolonged Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/ DAY Depakote (Valproate Semisodium) C Sudafed (Pseudoephedrine Hydrochloride) C Bc Powder C Genora 1/35 C Vicks Formula 44 C Testosterone Propionate C Prozac (Fluoxetine Hydrochloride) C Multivitamin C Date:11/29/01ISR Number: 3842117-6Report Type:Periodic Company Report #US_980604776 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Study Olanzapine PS 20 MG/ AT Initial or Prolonged Hallucination, Auditory Health BEDTIME Homicidal Ideation Professional Depakote (Valproate Hypersomnia Semisodium) C Intentional Self-Injury Depo Provera Paranoia (Medroxyprogresteron Suicidal Ideation e Acetate) C Date:11/29/01ISR Number: 3842118-8Report Type:Periodic Company Report #US_980808320 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Consumer Zyprexa(Olanzapine) PS 30 MG/DAY Initial or Prolonged Anxiety Lithium C Diabetes Mellitus Risperdal Drug Ineffective (Risperidone) C Overdose Ativan (Lorazepam) C Tremor Klonopin 24-Jun-2005 12:19 PM Page: 1691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Date:11/29/01ISR Number: 3842119-XReport Type:Periodic Company Report #US_980910023 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 20 MG/HS AT Initial or Prolonged Tangentiality Health BEDTIME Professional Placebo SS 5 MG Date:11/29/01ISR Number: 3842120-6Report Type:Periodic Company Report #US_010974420 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Study Olanzapine PS 5 MG/AT Initial or Prolonged Decreased Activity Health BEDTIME Mental Status Changes Professional Hydrochlorothiazide C Aspirin C Date:11/29/01ISR Number: 3842121-8Report Type:Periodic Company Report #US_010974422 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Blood Glucose Increased Professional Depakote (Valproate Company Semisodium) C Representative Date:11/29/01ISR Number: 3842122-XReport Type:Periodic Company Report #US_010974452 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Study Olanzapine PS 10 MG/ DAY Health Depakote (Valproate Professional Semisodium) C Date:11/29/01ISR Number: 3842123-1Report Type:Periodic Company Report #US_010974282 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 10 MG/AT Initial or Prolonged Health BEDTIME Professional Diphenhydramine C Date:11/29/01ISR Number: 3842124-3Report Type:Periodic Company Report #US_010974293 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Zyprexa (Olanzapine) PS 1 YR Professional 24-Jun-2005 12:19 PM Page: 1692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3843055-5Report Type:Periodic Company Report #US_010158883 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa (Olanzapine) PS Professional Estrogen Nos C Company Representative Date:11/29/01ISR Number: 3843058-0Report Type:Periodic Company Report #US_010158887 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Olanzapine PS 2 DSG Life-Threatening Health FORM/DAY Professional Vitamin E C Multivitamin C Timolol C Prednisolone C Olanzapine C Date:11/29/01ISR Number: 3843060-9Report Type:Periodic Company Report #US_010158917 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Study Olanzapine PS 6 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine Hydrochloride SS 75 MG/1 AT BEDTIME Multivitamin C Ventolin (Salbutamol) C Pulmicort (Budesonide) C Prevacid (Lansoprazole) C Serax (Oxazepam) C Celebrex (Celecoxib) C Indapamide C Zyrtec (Cetirizine Hydrochloride) C Midrin C Date:11/29/01ISR Number: 3843062-2Report Type:Periodic Company Report #US_010158989 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG/AT Initial or Prolonged Hallucination, Auditory Health BEDTIME Suicidal Ideation Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG/AT BEDTIME Advil (Ibuprofen) C 24-Jun-2005 12:19 PM Page: 1693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3843064-6Report Type:Periodic Company Report #US_010158993 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Zyprexa (Olanzapine) PS 125 MG/DAY Fatigue Professional Motion Sickness Overdose Supraventricular Extrasystoles Tachycardia Date:11/29/01ISR Number: 3843073-7Report Type:Periodic Company Report #US_010259070 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Study Olanzapine PS 10 MG AT Health BEDTIME Professional Nizatidine (Nizatidine) SS 150 MG/2 DAY Lotrisone C Sominex C Date:11/29/01ISR Number: 3843075-0Report Type:Periodic Company Report #US_010259111 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa (Olanzapine) PS 10 MG/AT Initial or Prolonged Gastrointestinal Health BEDTIME Disability Haemorrhage Professional Combivent C Other Myocardial Infarction Flovent (Fluticaone Propionate) C Levobunolol C Lipitor (Atorvastatin) C Atenolol C Ecotrin (Acetylsalicylic Acid) C Date:11/29/01ISR Number: 3843077-4Report Type:Periodic Company Report #US_010259201 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa (Olanzapine) PS 30 MG/DAY 6 MON Initial or Prolonged Schizoaffective Disorder Professional Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Zoloft (Sertraline Hydrochloride) C Date:11/29/01ISR Number: 3843078-6Report Type:Periodic Company Report #US_010259222 Age:28 YR Gender:Female I/FU:I Outcome PT Other Blood Glucose Increased Blood Triglycerides Increased 24-Jun-2005 12:19 PM Page: 1694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Increased Appetite Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa (Olanzapine) PS 20 MG/1 AT Professional BEDTIME Clonazepam C Oral Contraceptive Nos C Depo Provera (Medroxyprogesterone Acetate) C Date:11/29/01ISR Number: 3843080-4Report Type:Periodic Company Report #US_010259312 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Olanzapine PS 12 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/AT BEDTIME Lasix (Furosemide) C Vioxx (Rofecoxib) C Diovan (Valsartan) C Date:11/29/01ISR Number: 3843082-8Report Type:Periodic Company Report #US_990216907 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Olanzapine PS 10 MG/1 AT Initial or Prolonged Health BEDTIME Professional Placebo SS 2 MG/2 DAY Benztropine Mesylate C Triamcinolone Aceonide C Lidocaine C Aluminium & Magnesium Hydroxide/Dimeticone C Ibuprofen C Multivitamin And Mineral Supplement C Lorazepam C Date:11/29/01ISR Number: 3843084-1Report Type:Periodic Company Report #US_990218318 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 4 DSG Initial or Prolonged Schizophrenia Health FORM/1DAY Professional Placebo SS 2 DSG FORM/1DAY Lisinopril C Atenolol C Hydrochlorothiazide C Levothyroxine C 24-Jun-2005 12:19 PM Page: 1695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3843085-3Report Type:Periodic Company Report #US_990318604 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 10 MG/1 DAY Initial or Prolonged Health Professional Date:11/29/01ISR Number: 3843087-7Report Type:Periodic Company Report #US_990420579 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchial Carcinoma Study Olanzapine PS 15 MG/1 AT Initial or Prolonged Lobar Pneumonia Health BEDTIME Pneumonia Professional Albuterol C Ibuprofen C Insulin Human C Ipratropium C Multivitamin C Triamcinolone C Levovloxacin C Date:11/29/01ISR Number: 3843088-9Report Type:Periodic Company Report #US_990420644 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Study Olanzapine PS 25 MG/1 AT Hospitalization - Syndrome Health BEDTIME Initial or Prolonged Professional Ativan (Lorazepam) C Date:11/29/01ISR Number: 3843101-9Report Type:Periodic Company Report #US_ 990421336 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Olanzapine PS 3 DSG FORM/1 Initial or Prolonged Non-Insulin-Dependent Health DAY Diabetic Ketoacidosis Professional Tenormin (Atenolol) C Depakote (Valproate Semisodium) C Date:11/29/01ISR Number: 3843102-0Report Type:Periodic Company Report #US_990421484 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Valproic Acid PS 1000 MG/2 DAY Initial or Prolonged Health Zyprexa (Olanzapine) SS 10 MG Professional Fluoxetine C Synthroid (Levothyroxine Sodium) C Prempro C 24-Jun-2005 12:19 PM Page: 1696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3843103-2Report Type:Periodic Company Report #US_990522167 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Olanzapine PS 5 MG/1 AT Health BEDTIME Professional Coumadin (Warfarin Sodium) C Digoxin C Relafen (Nabumetone) C Multivitamin C Date:11/29/01ISR Number: 3843104-4Report Type:Periodic Company Report #US_990522667 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS 5 MG/1 AT Initial or Prolonged Fall Health BEDTIME Insomnia Professional Hyzaar C Aspirin C Date:11/29/01ISR Number: 3843105-6Report Type:Periodic Company Report #US_990623619 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Olanzapine PS 5 MG Initial or Prolonged Psychotic Disorder Health Prozac (Fluoxetine Professional Hydrochloride C Ortho-Novum C Date:11/29/01ISR Number: 3843106-8Report Type:Periodic Company Report #US_990623896 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Olanzapine PS 20 MG/DAY Initial or Prolonged Agitation Health Tylenol Depressed Mood Professional (Paracetamol) C Depression Olanzapine C Hallucination, Auditory Trilation Homicidal Ideation (Perphenazine) C Hostility Depakote (Valproate Insomnia Semisodium) C Mood Swings Pressure Of Speech Suicidal Ideation Date:11/29/01ISR Number: 3843108-1Report Type:Periodic Company Report #US_990624338 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Study Zyprexa (Olanzapine) PS 15 MG/1 AT Initial or Prolonged Health BEDTIME Professional Depakote (Valproate Semisodium) C Estrostep C Prozac (Fluoxetine Hydrochloride) C Cogentin 24-Jun-2005 12:19 PM Page: 1697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) C Date:11/29/01ISR Number: 3843109-3Report Type:Periodic Company Report #US_990725756 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Study Olanzapine PS 2 DSG FORM/1 Life-Threatening Dementia Alzheimer'S Type Health DAY Hospitalization - Lethargy Professional Prinivil Initial or Prolonged (Lisinopril) C Atenolol C Lanoxin (Digoxin) C Coumadin (Warfarin Sodium) C Atrial Fibrillation C Floropryl (Isoflurophate) C Glaucoma C Premarin (Estrogens Conjugated) C Vitamin E C Multivitamins C Calcium C Date:11/29/01ISR Number: 3843110-XReport Type:Periodic Company Report #US_990826612 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Study Olanzapine PS 15 MG/1 DAY Health Cogentin Professional (Benzatropine Mesilate) C Paxil (Paroxetine Hydrochloride) C Temazepam C Date:11/29/01ISR Number: 3843111-1Report Type:Periodic Company Report #US_990827336 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Study Olanzapine PS 10 MG Other Abnormal Health Ativan(Lorazepam) C Professional Date:11/29/01ISR Number: 3843112-3Report Type:Periodic Company Report #US_990927684 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Fluoxetine Initial or Prolonged Health (Fluoxetine Professional Hydrochloride) PS 20 MG/1 DAY Olanzapine SS 10 MG/1 DAY Glucophage (Metformin Hydrochloride) C Glucotrol Glipizide) C Cardizem Cd 24-Jun-2005 12:19 PM Page: 1698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Diltiazem Hydrochloride) C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Date:11/29/01ISR Number: 3843113-5Report Type:Periodic Company Report #US_990927748 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacteraemia Study Olanzapine PS 2.5 MG/2 DAY Hospitalization - Dehydration Health Furosemide C Initial or Prolonged Implant Site Infection Professional K-Dur (Potassium Disability Intraventricular Chloride) C Haemorrhage Norvasc (Amlodipine Pneumonia Besilate) C Urinary Tract Infection Paxil (Paroxetine Hydrochloride) C Vitamin C C Vitamin E C Aricept (Donepezil Hydrochloride) C Theragran-M C Pepcid (Famotidine) C Aristocort (Triamcinolone) C Jevity C Lotrisone C Bactroban (Mupirocin) C Maxiflor (Diflorasone Diacetate) C Mycolog C Multivitamin C Fiber C Tylenol C Date:11/29/01ISR Number: 3843114-7Report Type:Periodic Company Report #US_990927934 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Olanzapine PS 2.5 MG/1 DAY Initial or Prolonged Hallucination Health Insomnia Professional Date:11/29/01ISR Number: 3843115-9Report Type:Periodic Company Report #US_990928072 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Study Olanzapine PS 2 DSG FORM AT Initial or Prolonged Health BEDTIME Professional Zantac (Ranitidine Hydrochloride) C Vasotec (Enalapril Maleate) C Micronase (Glibenclamide) C Nitro Patch 24-Jun-2005 12:19 PM Page: 1699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Glyceryl Trinitrate) C Trimethoprim C Date:11/29/01ISR Number: 3843116-0Report Type:Periodic Company Report #US_990929005 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Olanzapine PS 5 MG Initial or Prolonged Health Placebo SS 1 MG Professional Multivitamin C Date:12/04/01ISR Number: 3833062-0Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Olanzapine PS ORAL 15MG PO QHS Muscle Rigidity Depakote C Tremor Amantadine C Colace C Lescol C Date:12/04/01ISR Number: 3833066-8Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Seroquel (25mg) PS 25 MG PO Hospitalization - Body Temperature (DAILY AS Initial or Prolonged Increased BID) Required Dehydration Prednisone (20 Mg) SS ORAL 20 MG PO (8 Intervention to Haematemesis PILLS Prevent Permanent Urine Ketone Body Present DISPENSED) Impairment/Damage White Blood Cell Count Prolixin Deconate Increased 50mg SS INTRAMUSCULAR 50 MG IM Q MONTH Zyprexa Zydis 5 Mg SS INTRAVENOUS 5 MG PO IVP Insulin C Liquid Prozac C Liquid Depakene C Depakote C Zanax C Klonopin C Date:12/04/01ISR Number: 3834828-3Report Type:Expedited (15-DaCompany Report #A126907 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Ziprasidone Po PS ORAL ORAL Initial or Prolonged Gynaecomastia Zyprexa SS ORAL ORAL Medication Error Depakote SS Topamax C 24-Jun-2005 12:19 PM Page: 1700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/01ISR Number: 3834884-2Report Type:Expedited (15-DaCompany Report #US_011177637 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/1 DAY, A FEW YEARS Desipramine C Carbamazepine C Date:12/05/01ISR Number: 3834886-6Report Type:Expedited (15-DaCompany Report #US_011177643 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serum Sickness Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Lithium C Date:12/05/01ISR Number: 3834887-8Report Type:Expedited (15-DaCompany Report #US_010974402 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa (Olanzapine) PS 10 MG/DAY Haematocrit Decreased Health Haemoglobin Decreased Professional Hyperhidrosis Hypoaesthesia Mean Cell Haemoglobin Concentration Decreased Mean Cell Volume Decreased Pallor Red Blood Cell Count Decreased Syncope Weight Increased Date:12/05/01ISR Number: 3834888-XReport Type:Expedited (15-DaCompany Report #US_011177618 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Zyprexa-Oral Initial or Prolonged Drug Interaction (Olanzapine) Mood Swings (Olanzapine) PS Zyban (Amfebutamone Hydrochloride) C Topiramate C Clonazepam C Date:12/05/01ISR Number: 3834904-5Report Type:Expedited (15-DaCompany Report #US_011177641 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Zyprexa-Oral PS 5 MG/DAY Initial or Prolonged Blood Calcium Decreased Professional Pravachol Other Hypoparathyroidism (Pravastatin Sodium) C 24-Jun-2005 12:19 PM Page: 1701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flovent (Fluticasone Propionate) C Lasix (Furosemide) C Depakote (Valproate Semisodium) C Prednisone C Date:12/05/01ISR Number: 3834929-XReport Type:Expedited (15-DaCompany Report #US_010973640 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Condition Aggravated Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Haldol (Haloperidol) C Date:12/05/01ISR Number: 3835036-2Report Type:Expedited (15-DaCompany Report #US_0110755262 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa (Olanzapine) PS 10 MG/DAY 5 YR Life-Threatening Cardiomyopathy Professional Hospitalization - Convulsion Initial or Prolonged Diabetes Mellitus Insulin-Dependent Enterobacter Infection Implant Site Infection Lung Infiltration Pyrexia Ventricular Fibrillation Date:12/05/01ISR Number: 3835100-8Report Type:Expedited (15-DaCompany Report #US_011076380 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Phosphatase Increased Health Haloperidol C Blood Cholesterol Professional Zotepine C Increased Company Risperidone C Blood Glucose Increased Representative Akineton (Biperiden Blood Pressure Increased Other Hydrochloride) C Cyanosis Hirnamin Grand Mal Convulsion (Levomepromazine) C Heart Rate Increased Pyrethia Respiratory Arrest (Promethazine Restlessness Hydrochloride) C Date:12/05/01ISR Number: 3835102-1Report Type:Expedited (15-DaCompany Report #EWC011129096 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Zyprexa-Oral Completed Suicide Health (Olanzapine)(Olanzap Depression Professional ine) PS 10 MG/DAY Company Rivotril Representative (Clonazepam) C Other 24-Jun-2005 12:19 PM Page: 1702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/01ISR Number: 3835105-7Report Type:Expedited (15-DaCompany Report #EWC011129086 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine)(Olanzap Aspartate Professional ine) PS 10 MG/DAY Aminotransferase Company Increased Representative Blood Bilirubin Increased Other Hepatic Steatosis Jaundice Cholestatic Liver Function Test Abnormal Somnolence Date:12/05/01ISR Number: 3835106-9Report Type:Expedited (15-DaCompany Report #EWC011129071 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Diastolic Foreign Zyprexa-Oral Increased Health (Olanzapine) Cardiac Disorder Professional (Olanzapine) PS 10 MG/DAY Cardiomegaly Company Zestril (Lisinopril) C Congestive Cardiomyopathy Representative Eucardic Dilatation Ventricular Other (Carvedilol) C Dyspnoea Exacerbated Furosemide C Echocardiogram Abnormal Losec (Omeprazole) C Electrocardiogram St-T Segment Abnormal Heart Rate Increased Hypokinesia Mitral Valve Incompetence Oedema Peripheral Pneumonia Tricuspid Valve Incompetence Ventricular Extrasystoles Weight Increased Date:12/05/01ISR Number: 3835108-2Report Type:Expedited (15-DaCompany Report #EWC011129041 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Weight Increased Foreign Zyprexa-Oral Health (Olanzapine)(Olanzap Professional ine) PS 20 MG/DAY Company Representative Other Date:12/05/01ISR Number: 3835140-9Report Type:Expedited (15-DaCompany Report #EWC011129039 Age: Gender:Male I/FU:I Outcome PT Report Source Death Overdose Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 1703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Date:12/05/01ISR Number: 3835315-9Report Type:Expedited (15-DaCompany Report #AU_011104437 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Zyprexa-Oral Initial or Prolonged Purpura Health (Olanzpine) Professional (Olanzapine) PS 2.5 MG/IN THE Company EVENING Representative Madopar 125 C Other Florinef (Fludrocortisone Acetate) C Cardiprin (Acetylsalicylic Acid) C Date:12/05/01ISR Number: 3835316-0Report Type:Expedited (15-DaCompany Report #DE_011107392 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Foreign Zyprexa-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY A Other FEW YEARS Date:12/05/01ISR Number: 3835317-2Report Type:Expedited (15-DaCompany Report #FR_011100382 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Loxapac (Loxapine Representative Succinate) C Other Tercian (Cyamemazine) C Date:12/05/01ISR Number: 3835651-6Report Type:Expedited (15-DaCompany Report #US_011076561 Age:61 YR Gender:Female I/FU:F Outcome PT Hospitalization - Decreased Activity Initial or Prolonged Decubitus Ulcer Depressed Level Of Consciousness Diabetes Mellitus Diabetic Hyperglycaemic Coma Difficulty In Walking Dysstasia Erythema Somnolence 24-Jun-2005 12:19 PM Page: 1704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ulcer Varicella Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Rohypnol Professional (Flunitrazepam) C Company Aricept (Donepezil Representative Hydrochloride) C Other Hiberna (Promethazine Hydrochloride) C Daonil (Glibenclamide) C Date:12/05/01ISR Number: 3835661-9Report Type:Expedited (15-DaCompany Report #US_011076460 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Foreign Zyprexa-Oral Myocardial Infarction Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Vegetamin A C Representative Brotizolam C Other Date:12/05/01ISR Number: 3835669-3Report Type:Expedited (15-DaCompany Report #EWC011129042 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Other Accuprin (Quinapril Increased Hydrochloride) C Blood Alkaline Aspirinetta Phosphatase Increased (Acetylsalicyclic Gamma-Glutamyltransferase Acid) C Increased Bi-Euglucon M C Jaundice Date:12/05/01ISR Number: 3835705-4Report Type:Expedited (15-DaCompany Report #EWC11129025 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Foreign Olanzapine PS 70 DSG FORM Hospitalization - Hyperpyrexia Health Initial or Prolonged Loss Of Consciousness Professional Neuroleptic Malignant Other Syndrome Overdose Restlessness Suicide Attempt Tachycardia 24-Jun-2005 12:19 PM Page: 1705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/01ISR Number: 3835706-6Report Type:Expedited (15-DaCompany Report #US_011176762 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Increased Health Dogmatyl (Sulpiride) C Aspartate Professional Lodopin (Zotepine) C Aminotransferase Company Linton (Haloperidol) C Increased Representative Tasmolin (Biperiden) C Haematocrit Decreased Other Hiberna Haemoglobin Decreased (Promethazine Platelet Count Decreased Hydrochlirde) C Red Blood Cell Count Penselin Decreased (Dipyridamole) C White Blood Cell Count Silece Decreased (Flunitrazepam) C Tinelac (Sennoside A+B) C Date:12/05/01ISR Number: 3835707-8Report Type:Expedited (15-DaCompany Report #DE_011007115 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Health Valproic Acid C Professional Other Date:12/05/01ISR Number: 3836291-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Zyprexa(2.5mg Initial or Prolonged Diabetic Ketoacidosis Tablets)(Lilly) PS Lilly PLEASE SEE Required B-5 Intervention to Duricef C Prevent Permanent Gemfibrozil C Impairment/Damage Vasotec C Questran Packet C Hytrin C Enteric Coated Asa C Ibuprofen C Valproic Acid C Acetaminophen C Thioridazine C Chronulac C Zincate C Mom C Metamucil C Surfak C Famotidine C Lotrimin Cr C Lotrisone Cr C Anusol Hc C Baby Power C Zeasorb C Multiple Vitamins C Selenium C 24-Jun-2005 12:19 PM Page: 1706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/01ISR Number: 3836320-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Zyprexa PS Date:12/05/01ISR Number: 3836323-4Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Zyprexa PS Date:12/10/01ISR Number: 3838307-9Report Type:Direct Company Report # Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Zyprexa 2.5 PS ORAL 2.5 BID ORAL Initial or Prolonged Chest Pain Celexa 30 SS ORAL 30 QAM ORAL Sinus Bradycardia Metoprolol C Nifedipine Sr C Hydralazine C Digoxin C Lasix C Zocor C Isordil C Depakote C Insulin C Folate C Oxycontin C Zantac C Mvi C Colace C Vicodin C Zyprexa C ... C Date:12/11/01ISR Number: 3838350-XReport Type:Expedited (15-DaCompany Report #US_011178245 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa-Oral Blood Prolactin Increased Professional (Olanzapine) Epistaxis Company (Olanzapine) PS Representative Risperdal (Risperidone) C Date:12/11/01ISR Number: 3838352-3Report Type:Expedited (15-DaCompany Report #US_011178079 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Health Zyprexa-Oral Renal Failure Acute Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Diflucan (Fluconazole) C Haldol (Halperidol) C 24-Jun-2005 12:19 PM Page: 1707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838353-5Report Type:Expedited (15-DaCompany Report #US_011178033 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa-Oral Hyperkalaemia Professional (Olanzapine) (Olanzapine) PS 2.5 MG/DAY 1 DAY Cytoxan (Cyclophosphamide) C Lasix (Furosemide) C Synthroid (Levothyroxine Sodium) C Date:12/11/01ISR Number: 3838354-7Report Type:Expedited (15-DaCompany Report #US_011178045 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Gun Shot Wound (Olanzapine) (Olanzapine) PS Date:12/11/01ISR Number: 3838379-1Report Type:Expedited (15-DaCompany Report #US_011075489 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Zyprexa -Oral Heart Rate Decreased Professional (Olanzapine ) (Olanzapine) PS 5 MG/1 DAY Atenolol C Date:12/11/01ISR Number: 3838402-4Report Type:Expedited (15-DaCompany Report #US_011075861 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine)(Olanzap User Facility ine) PS 2.5 MG/DAY 1 DAY Company Representative Date:12/11/01ISR Number: 3838445-0Report Type:Expedited (15-DaCompany Report #EWC011129143 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Striae Foreign Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Other Efexor (Venlafaxine Hydrochloride) C Date:12/11/01ISR Number: 3838446-2Report Type:Expedited (15-DaCompany Report #AU_010703761 Age: Gender:Male I/FU:I Outcome PT Report Source Other Haemolytic Anaemia Foreign Health 24-Jun-2005 12:19 PM Page: 1708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS Date:12/11/01ISR Number: 3838449-8Report Type:Expedited (15-DaCompany Report #US_011178231 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Olanzapine-Oral Initial or Prolonged Extrapyramidal Disorder Study (Olanzapine) PS 10 MG DAY Gastric Ulcer Haemorrhage Health Valproate Sodium C Professional Clonazepam C Trihexyphenidyl C Levomepromazine C Date:12/11/01ISR Number: 3838462-0Report Type:Expedited (15-DaCompany Report #EWC011028709 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Olanzapine PS 1 MG/DAY Initial or Prolonged Vomiting Study Tenormine (Atenolol) C Health Skenan (Morphine Professional Sulfate) C Other Calcite D C Exelon (Rivastigmine Tartrate) C Motilium (Domperidone) C Umuline Profil 30 (Insulin Human Injection, Isophane) C Hydromorphone Hydrochloride C Date:12/11/01ISR Number: 3838466-8Report Type:Expedited (15-DaCompany Report #US_011076268 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Electrocardiogram Qt Health Haloperidol Corrected Interval Professional Decanoate C Prolonged Company Serenace Electrocardiogram Qt Representative (Haloperidol) C Prolonged Other Akineton (Biperiden Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Silece (Flunitrazepam) C Amoban (Zopiclone) C Levotomin (Levomepromazine Maleate) C Hiberna (Promethazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Selbex (Teprenone) C Magnesium Oxide C Date:12/11/01ISR Number: 3838472-3Report Type:Expedited (15-DaCompany Report #US_011178007 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Blood Alkaline Health (Olanzapine) PS 5 MG/DAY Other Phosphatase Increased Professional Aspirine Blood Bilirubin Increased Other (Acetylsalicylic Hepatic Enzyme Increased Acid) C Jaundice Tilazem (Diltiazem Hydrochloride) C Date:12/11/01ISR Number: 3838497-8Report Type:Expedited (15-DaCompany Report #US_011178274 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Limb Fracture Foreign Zyprexa-Oral Initial or Prolonged Suicide Attempt Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Representative Other Date:12/11/01ISR Number: 3838500-5Report Type:Expedited (15-DaCompany Report #US_011178209 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Hospitalization - Diabetic Coma Health (Olanzapine) Initial or Prolonged Hyperglycaemia Professional (Olanzapine) PS 15 MG/DAY Other Company Representative Other Date:12/11/01ISR Number: 3838509-1Report Type:Expedited (15-DaCompany Report #GBS011109692 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myeloid Leukaemia Foreign Zyprexa (Olanzapine) PS 30 MG/DAY Hospitalization - Pneumonia Health Fluoxetine C Initial or Prolonged Professional Modecate Other (Fluphenazine Decanoate) C Diazepam C Depo-Provera (Medroxyprogesteron Acetate) C 24-Jun-2005 12:19 PM Page: 1710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838534-0Report Type:Expedited (15-DaCompany Report #EWC011129042 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholangitis Foreign Zyprexa-Oral Initial or Prolonged Jaundice Health (Olanzapine) Liver Disorder Professional (Olanzapine) PS 10 MG/DAY Other Accuprin (Quinapril Hydrochloride) C Aspirinetta (Acetylsalicylic Acid) C Bi-Euglucon M C Date:12/11/01ISR Number: 3838535-2Report Type:Expedited (15-DaCompany Report #EWC011129041 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Representative Other Date:12/11/01ISR Number: 3838536-4Report Type:Expedited (15-DaCompany Report #EWC000506724 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Prozac-Oral Initial or Prolonged Exposure To Therapeutic Health (Fluoxetine) Drugs Professional (Fluoxetine Cyanosis Neonatal Company Hydrochloride) PS Hypotonia Neonatal Representative Zyprexa-Oral Neonatal Apnoeic Attack Other (Olanzapine) Respiratory Tract (Olanzapine) SS Infection Lysanxia (Prazepam) C Somnolence Neonatal Tercian (Cyamemazine) C Hept-A-Myl (Heptaminol Hydrochloride) C Date:12/11/01ISR Number: 3838537-6Report Type:Expedited (15-DaCompany Report #EWC000607143 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Prozac (Fluoxetine Initial or Prolonged Exposure To Therapeutic Health Hydrochloride) PS Drugs Professional Zyprexa (Olanzapine) SS Cyanosis Neonatal Other Heptaminol C Hypotonia Neonatal Tercian Neonatal Apnoeic Attack (Cyamemazine) C Somnolence Neonatal Lysanxia (Prazepam) C 24-Jun-2005 12:19 PM Page: 1711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838541-8Report Type:Expedited (15-DaCompany Report #2001-11-1906 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Trilafon Hospitalization - Sudden Death Health (Perphenazine) Initial or Prolonged Professional Tablets PS ORAL 8 MG/DAY ORAL Other Zoloft Tablets SS ORAL 100 MG/DAY ORAL Zyprexa (Olanzapine) Tablets SS ORAL 7.5 MG/DAY ORAL Pamol C Date:12/11/01ISR Number: 3838556-XReport Type:Expedited (15-DaCompany Report #EWC011129004 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Calmaxid Initial or Prolonged Anaemia Health (Nizatidine) PS 300 MG/DAY C-Reactive Protein Professional Zyprexa (Olanzapine) SS 20 MG/DAY Increased Other Ludiomil(Maprotiline Change Of Bowel Habit Hydrochloride) C Diverticulitis Quilonorm (Lithium Haematoma Acetate) C Hepatic Infarction Liver Abscess Salpingitis Vasculitis Weight Increased Date:12/11/01ISR Number: 3839020-4Report Type:Expedited (15-DaCompany Report #US_010974040 Age:32 YR Gender:Male I/FU:F Outcome PT Death Acute Tonsillitis Hospitalization - Blister Initial or Prolonged Blood Alkaline Other Phosphatase Increased Blood Creatinine Increased C-Reactive Protein Increased Convulsion Decreased Appetite Dehydration Depressed Level Of Consciousness Depression Diabetes Mellitus Diabetic Coma Diabetic Ketoacidosis Hypernatraemia Hyperphagia Hyperuricaemia Hypokalaemia Hyponatraemia Loss Of Consciousness Metabolic Acidosis Pharyngitis 24-Jun-2005 12:19 PM Page: 1712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharyngolaryngeal Pain Polydipsia Thirst Report Source Product Role Manufacturer Route Dose Duration Tonsillar Hypertrophy Foreign Zyprexa-Oral PS 10 MG/DAY Tonsillitis Health Risperdal Weight Increased Professional (Risperidone) C Company Artane(Trihexyphenid Representative yl Hydrochloride) C Other Rohypnol(Flunitrazep am) C Halcion(Triazolam) C Date:12/11/01ISR Number: 3839111-8Report Type:Expedited (15-DaCompany Report #DE_010505818 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Zyprexa (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Increased Literature Lanitop Condition Aggravated Health (Metildigoxin) C Drug Interaction Professional Syntestan Hyperglycaemia Other (Cloprednol) C Infection Remergil Respiratory Tract (Mirtazapine) C Infection Pulmicort Turbuhaler (Budesonide) C Berotec Inhaler (Fenoterol) C Calcium C Vigantoletten (Colecalciferol) C Godamed C Ampho Moronal "Bristol-Myers Squibb" (Amphotericin B) C Propycil (Propylthiouracil) C Rulid (Roxithromycin) C Kalinor (Potassium Chloride) C Date:12/11/01ISR Number: 3839112-XReport Type:Expedited (15-DaCompany Report #US_011076251 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Electrocardiogram Health Lendormin Abnormal Professional (Brotizolam) C Electrocardiogram Qt Company Amlodin (Amlodipine Prolonged Representative Besilate) C Pyrexia Other Lasix (Furosemide) C Myonal (Eperisone Hydrochloride) C Foipan (Camostat Mesilate) C Aspara K (Aspartate Potassium) C Nitrol (Glyceryl 24-Jun-2005 12:19 PM Page: 1713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trinitrate) C Date:12/12/01ISR Number: 3839831-5Report Type:Expedited (15-DaCompany Report #A128171 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Zoloft Tablets PS ORAL 100.00 MG Hospitalization - Sudden Death Health TOTAL:DAILY:O Initial or Prolonged Professional RAL Other Perphenazin SS ORAL 8.00 MG TOTAL:DAILY:O RAL Olanzapin SS ORAL 7.50 MG TOTAL:DAILY:O RAL Paracetamol C Date:12/12/01ISR Number: 3840220-8Report Type:Expedited (15-DaCompany Report #01-1953 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Loxitane (Loxapac) Hospitalization - Somnolence Health Capsules PS Wyeth Ayerst ORAL 15 MG 1 X PER Initial or Prolonged Professional 1 DAY, ORAL 305 DAY Company Risperdal Representative (Risperidone), Manufacturer Unknown SS ORAL 500 UG 1 X PER 1 DAY, ORAL 28 DAY Serenase (Haloperidol) SS ORAL 2 MG 1 X PER 1 DAY, ORAL 305 DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG 1 X PER 1 DAY, ORAL 301 DAY Date:12/13/01ISR Number: 3839403-2Report Type:Expedited (15-DaCompany Report #EMADSS2001007112 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Haldol (Unspecified) Somnolence Health (Haloperidol) PS ORAL 2 MG, DAILY, Professional ORAL Risperidone (Unspecified) (Risperidone) SS ORAL 500 MCG, DAILY, ORAL Loxapac (Loxapine Succinate) SS ORAL 15 MG, DAILY. ORAL Olanzapine (Olanzapine) SS ORAL 2.5 MG, DAILY, ORAL 24-Jun-2005 12:19 PM Page: 1714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/01ISR Number: 3840456-6Report Type:Expedited (15-DaCompany Report #PHRM2001FR02734 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Tegretol Drug Exposure During Other (Carbamazepine) Pregnancy Tablet PS ORAL ORAL Pregnancy Mirtazapine (Mirtazapine) Tablet SS ORAL 15 MG, TID, ORAL Zyprexa (Olanzapine) Tablet SS ORAL 10 MG, QD, ORAL Date:12/14/01ISR Number: 3840943-0Report Type:Expedited (15-DaCompany Report #EMADSS2001007112 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Risperidone Somnolence Health (Unspecified) Professional (Risperidone) PS ORAL 500 MCG, DAILY, ORAL Haldol(Unspecified)( Haloperidol) SS ORAL 2 MG, DAILY, ORAL Loxapac(Loxapine Succinate) SS ORAL 15 MG, DAILY, ORAL Olanzapine(Olanzapin e) SS ORAL 2.5 MG, DAILY, ORAL Date:12/17/01ISR Number: 3839972-2Report Type:Direct Company Report # Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Zyprexa PS ORAL 5MG AM/10MG Initial or Prolonged Blood Glucose Increased HS PO Blood Pressure Increased Neurontin SS 300MG BID Lethargy Date:12/18/01ISR Number: 3841902-4Report Type:Expedited (15-DaCompany Report #2015123 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Morphine Sulfate Coma Professional (Similar To Andas Pulmonary Congestion Other 74-769 And 74-862) PS Pulmonary Oedema Oxycodone Therapeutic Agent Hydrochloride Toxicity (Similar To Nda Toxicologic Test Abnormal 20-553) SS Codeine SS ORAL PO Olanzapine SS ORAL PO Acetaminophen SS ORAL PO Paroxetine SS ORAL PO Bupropion SS ORAL PO Nicotine SS ORAL PO 24-Jun-2005 12:19 PM Page: 1715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3842140-1Report Type:Expedited (15-DaCompany Report #US_011076251 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Electrocardiogram Health Lendormin Abnormal Professional (Brotizolam) C Electrocardiogram Qt Company Amlodin (Amlodipine Prolonged Representative Besilate) C Hypokalaemia Other Lasix (Furosemide) C Pyrexia Myonal (Eperisone Hydrochloride) C Foipan (Camostat Mesilate) C Aspara K (Aspartate Potassium) C Nitrol (Glyceryl Trinitrate) C Date:12/19/01ISR Number: 3842154-1Report Type:Expedited (15-DaCompany Report #GBS011209836 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Duodenal Ulcer Foreign Zyprexa-Oral Perforation Health (Olanzapine) Myocardial Infarction Professional (Olanzapine) PS 20 MG/DAY Other Date:12/19/01ISR Number: 3842155-3Report Type:Expedited (15-DaCompany Report #GBS011209824 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Foreign Zyprexa-Oral Decreased Activity Health (Olanzapine) Face Oedema Professional (Olanzapine) PS 5 MG/DAY Mental Impairment Other Citalopram C Zopiclone C Diazepam C Bactroban (Mupirocin) C Lorazepam C Date:12/19/01ISR Number: 3842165-6Report Type:Expedited (15-DaCompany Report #US_011278464 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Starvation Foreign Zyprexa-Oral Health (Olanzapine) PS 20 MG/DAY Professional Wintermin Company (Chlorpromazine Representative Hydrochloride) C Other Levotomin (Levomepromazine Maleate) C Halcion (Triazolam) C Tasmolin (Biperiden) C Proheparum C 24-Jun-2005 12:19 PM Page: 1716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3842166-8Report Type:Expedited (15-DaCompany Report #US_011278481 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Foreign Zyprexa-Oral Drug Level Above Health (Olanzapine) PS 10 MG/DAY Therapeutic Professional Depakene (Valproate Drug Toxicity Company Sodium) C Somnolence Representative Zantac (Ranitidine Speech Disorder Other Hydrochloride) C Tremor Methycobal C Urinary Tract Infection Aplace (Troxipide) C Loxonin (Loxi Profen Sodium) C Chloramphenicol C Luvox (Fluvoxamine Maleate) C Zolpidem C Depas (Etizolam) C Serenace (Haloperidol) C Date:12/19/01ISR Number: 3842167-XReport Type:Expedited (15-DaCompany Report #GBS011209838 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Foreign Zyprexa-Oral Initial or Prolonged Hormone Increased Health (Olanzapine) PS 10 MG Hyperthyroidism Professional Phenelzine C Mental Disorder Other Risperidone C Tachycardia Nafazodone C Thyroxine Free Increased Thyroxine C Chlorpromazine C Date:12/19/01ISR Number: 3842168-1Report Type:Expedited (15-DaCompany Report #GBS011209837 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mobility Decreased Foreign Zyprexa-Oral Posture Abnormal Health (Olanzapine) Professional (Olanzapine) PS 5 MG Other Cefalexin C Zopiclone C Lorazepam C Diazepam C Date:12/19/01ISR Number: 3842169-3Report Type:Expedited (15-DaCompany Report #DE_011207543 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Neoplasm Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other 24-Jun-2005 12:19 PM Page: 1717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3842170-XReport Type:Expedited (15-DaCompany Report #EWC011229288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Zyprexa-Oral Hospitalization - Dysarthria Health (Olanzapine) Initial or Prolonged Feeling Abnormal Professional (Olanzapine) PS 20000 MG/DAY Other Hallucination, Visual Other Heart Rate Increased Overdose Sleep Attacks Somnolence Speech Disorder Suicide Attempt Therapeutic Agent Toxicity Date:12/19/01ISR Number: 3842171-1Report Type:Expedited (15-DaCompany Report #FR_011200434 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Depo Provera (Medroxyprogesterone Acetate) C Date:12/19/01ISR Number: 3842188-7Report Type:Expedited (15-DaCompany Report #EWC011129041 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS ORAL 20 MG/DAY Company Representative Other Date:12/19/01ISR Number: 3842189-9Report Type:Expedited (15-DaCompany Report #FR_011000306 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Pulmonary Embolism Health Gardenal Professional (Phenobarbital) C Other Tegretol (Carbamazepine) C Tercian (Cyamenazine) C Seresta (Oxazepam) C Date:12/19/01ISR Number: 3842191-7Report Type:Expedited (15-DaCompany Report #US_010974040 Age:32 YR Gender:Male I/FU:F Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 1718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration C-Reactive Protein Foreign Zyprexa-Oral Increased Health (Olanzapine) Convulsion Professional (Olanzapine) PS 10 MG/DAY Decreased Appetite Company Risperdal Dehydration Representative (Risperidone) C Diabetic Hyperosmolar Other Artane Coma (Trihexyphenidyl Diabetic Ketoacidosis Hydrochloride) C Hepatic Enzyme Increased Rohypnol Hyperuricaemia (Flunitrazepam) C Hypokalaemia Halcion (Triazolam) C Hyponatraemia Metabolic Acidosis Nervousness Renal Failure Restlessness Tonsillitis Weight Increased Date:12/19/01ISR Number: 3842192-9Report Type:Expedited (15-DaCompany Report #EWC011129039 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Foreign Zyprexa-Oral Overdose Health (Olanzapine) Professional (Olanzapine) PS 15 MG/1 DAY Company Representative Other Date:12/19/01ISR Number: 3842194-2Report Type:Expedited (15-DaCompany Report #US_011076380 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Zyprexa-Oral Phosphatase Increased Health (Olanzapine) Blood Cholesterol Professional (Olanzapine) PS 20 MG/DAY Increased Company Haloperidol C Blood Glucose Increased Representative Zotepine C Blood Pressure Increased Other Risperidone C Cyanosis Akineton (Biperiden Fall Hydrochloride) C Feeling Abnormal Hirnamin Grand Mal Convulsion (Levomepromazine) C Heart Rate Increased Pyrethia Respiratory Arrest (Promethazine Restlessness Hydrochloride) C Date:12/19/01ISR Number: 3842227-3Report Type:Expedited (15-DaCompany Report #US_011076268 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Other Electrocardiogram Qt Foreign Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG/DAY Haloperidol Decanoate C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Silece (Flunitrazepam) C Amoban (Zopiclone) C Levotomin (Levomepromazine Maleate) C Hiberna (Promethazine Hydrochloride) C Selbex (Teprenone) C Magnesium Oxide C Date:12/19/01ISR Number: 3842264-9Report Type:Expedited (15-DaCompany Report #EWC011128920 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Blood Lactate Health Clopixol Dehydrogenase Increased Professional (Zuclopenthixol Malaise Other Decanoate) C Tavor (Lorazepam) C Date:12/19/01ISR Number: 3842269-8Report Type:Expedited (15-DaCompany Report #DE_011007112 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Leukopenia Health Carbamazepine C Underweight Professional Trimipramine C Other Date:12/19/01ISR Number: 3842272-8Report Type:Expedited (15-DaCompany Report #DE_010806602 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Foreign Zypreza-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/ 1 DAY Other 24-Jun-2005 12:19 PM Page: 1720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3842274-1Report Type:Expedited (15-DaCompany Report #US_011178209 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Hospitalization - Diabetic Coma Health (Olanzapine) Initial or Prolonged Diabetic Hyperosmolar Professional (Olanzapine) PS 10 MG/DAY Other Coma Company Timiperone C Hyperglycaemia Representative Biperiden C Hypoxia Other Weight Decreased Date:12/19/01ISR Number: 3842553-8Report Type:Expedited (15-DaCompany Report #US_011278580 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Literature Olanzapine-Oral Initial or Prolonged Aggression Health (Olanzapine) PS 15 MG/DAY Agitation Professional Fluphenazine C Blood Potassium Increased Benztropine C Blood Urea Increased Valproic Acid C Convulsion Diabetes Mellitus Folliculitis Hypoglycaemia Incontinence Ketoacidosis Ketonuria Nausea Petit Mal Epilepsy Pollakiuria Thrombocytopenia Vomiting Weight Decreased Date:12/19/01ISR Number: 3842555-1Report Type:Expedited (15-DaCompany Report #US_011278839 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Paxil (Paroxetine Hydrochloride) C Date:12/19/01ISR Number: 3842566-6Report Type:Expedited (15-DaCompany Report #US_011278604 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other 24-Jun-2005 12:19 PM Page: 1721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3842586-1Report Type:Expedited (15-DaCompany Report #AU_011204498 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 20 MG/DAY Professional Company Representative Other Date:12/19/01ISR Number: 3842588-5Report Type:Expedited (15-DaCompany Report #US_011178213 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Olanzapine-Oral Condition Aggravated Literature (Olanzapine) PS 15 MG/DAY Delusion Health Drug Ineffective Professional Dystonia Other Extrapyramidal Disorder Hallucination Petit Mal Epilepsy Date:12/19/01ISR Number: 3842596-4Report Type:Expedited (15-DaCompany Report #USA011210119 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Renal Failure Professional (Olanzapine) Other (Olanzapine) PS Lithium C Date:12/19/01ISR Number: 3842686-6Report Type:Expedited (15-DaCompany Report #US_011176945 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa-Oral Initial or Prolonged Coma Professional (Olanzapine) Diabetes Mellitus (Olanzapine) PS 1500 MG/DAY 1 DAY Non-Insulin-Dependent Xanax (Alprazolam) C Hypoaesthesia Zoloft (Sertraline Overdose Hydrochloride) C Pain In Extremity Wellbutrin Pneumonia Aspiration (Amfebutamone Rhabdomyolysis Hydrochloride) C Lorazepam C Synthroid (Levothyroxine Sodium) C Hydrochlorothiazide C Date:12/19/01ISR Number: 3843146-9Report Type:Expedited (15-DaCompany Report #USA011110015 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Health Professional 24-Jun-2005 12:19 PM Page: 1722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 40 MG/DAY Date:12/20/01ISR Number: 3843226-8Report Type:Expedited (15-DaCompany Report #HQ9568318DEC2001 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Study Trevilor Initial or Prolonged (Venlafaxine Other Hydrochloride, Tablet) PS ORAL SEE IMAGE 7 DAY Eunerpan (Melperone Hydrochloride) SS ORAL 100 MG 1X PER 1 DAY 4 DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG 1X PER 1 DAY 23 DAY Remergil (Mirtazapine) C Beloc Zok (Metoprolol Succinate) C Duspatal (Mebeverine) C Antra (Omeprazole) C Date:12/20/01ISR Number: 3844671-7Report Type:Periodic Company Report #HQ5926713SEP2001 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Effexor Xr Professional (Venlafaxine Company Hydrochloride, Representative Capsule, Extended Release) PS ORAL ORAL Buspar (Buspirone Hydrochloride) SS Clonopin (Clonazepam) SS Trazodone (Trazodone) SS Zyprexa (Olanzapine) SS Date:12/21/01ISR Number: 3843712-0Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olanzapine PS Syndrome Quetiapine SS 24-Jun-2005 12:19 PM Page: 1723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/01ISR Number: 3844078-2Report Type:Expedited (15-DaCompany Report #01P-055-0113799-00 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cataract Foreign Depakine Tablets Health (Sodium Valproate PS ORAL 500 MG, 1 IN Professional 1 D, PER ORAL Other Olanzapine SS ORAL 5 MG, 1 IN 1 D, PER ORAL Date:12/27/01ISR Number: 3844300-2Report Type:Expedited (15-DaCompany Report #A0162401A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Zyban PS Glaxo Wellcome ORAL 150MG Per day 1 WK Initial or Prolonged Drug Effect Decreased Topamax SS UNKNOWN Loss Of Employment Zyprexa SS UNKNOWN Mania Klonopin SS UNKNOWN 1MG Unknown Mood Swings Suicidal Ideation Tobacco Abuse Date:12/27/01ISR Number: 3845081-9Report Type:Expedited (15-DaCompany Report #GBS011209880 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Neonatal Foreign Zyprexa-Oral Drug Exposure During Health (Olanzapine) PS TRANSPLACENTAL Pregnancy Professional Somnolence Neonatal Other Date:12/27/01ISR Number: 3845082-0Report Type:Expedited (15-DaCompany Report #US_011279301 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa-Oral Hospitalization - Condition Aggravated Health (Olanzapine) Initial or Prolonged Haemodialysis Professional (Olanzapine) PS 5 MG/DAY Insomnia Company Brotizolam C Intentional Misuse Representative Doral (Quazepam) C Memory Impairment Other Contomin Pyrexia (Chlorpromazine Rhabdomyolysis Hydrochloride) C Suicidal Ideation Horizon (Diazepam) C Vomiting Date:12/27/01ISR Number: 3845083-2Report Type:Expedited (15-DaCompany Report #US_011279411 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Hyperosmolar Foreign Zyprexa-Oral Coma Health (Olanzapine) PS ORAL 10 MG/DAY Professional Wypax (Lorazepam) C Company Representative Other 24-Jun-2005 12:19 PM Page: 1724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845089-3Report Type:Expedited (15-DaCompany Report #EWC011229464 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Zyprexa-Oral Hospitalization - Congestive Health (Olanzapine) Initial or Prolonged Disorientation Professional (Olanzapine) PS 2.5 MG DAY Hypoglycaemic Coma Company Rocefin (Ceftriaxone Myocardial Ischaemia Representative Sodium) C Other Enapren (Enalapril Maleate) C Lasix (Furosemide) C Clexane (Heparin-Fraction, Sodium Salt) C Actrapid (Insulin) C Zantac (Ranitidine Hydrochloride) C Date:12/27/01ISR Number: 3845090-XReport Type:Expedited (15-DaCompany Report #CA_011204621 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epistaxis Foreign Olanzapine-Oral Loss Of Consciousness Health (Olanzapine) PS 20 MG AT Mouth Haemorrhage Professional BEDTIME Other Ventolin (Salbutamol) C Date:12/27/01ISR Number: 3845091-1Report Type:Expedited (15-DaCompany Report #US_011279485 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Foreign Olanzapine-Oral Initial or Prolonged Gastrointestinal Disorder Consumer (Olanzapine) PS Congenital Other Haloperidol C Maternal Drugs Affecting Levomepromazine C Foetus Premature Baby Pulmonary Oedema Neonatal Skull Malformation Date:12/27/01ISR Number: 3845092-3Report Type:Expedited (15-DaCompany Report #DE_011207599 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysarthria Foreign Zyprexa-Oral Hospitalization - Hyponatraemia Health (Olanzapine) Initial or Prolonged Soft Tissue Injury Professional (Olanzapine) PS 20 MG/DAY Status Epilepticus Other Promethazine C Tongue Disorder Date:12/27/01ISR Number: 3845093-5Report Type:Expedited (15-DaCompany Report #DE_011207615 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Foreign Health 24-Jun-2005 12:19 PM Page: 1725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 15 MG/DAY Date:12/27/01ISR Number: 3845137-0Report Type:Expedited (15-DaCompany Report #US_011178274 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Zyprexa Initial or Prolonged Foot Fracture Health (Olanzapine) PS 20 MG/DAY Insomnia Professional Trihexyphenidyl C Lower Limb Fracture Company Sennoside A C Suicide Attempt Representative Benzodiazepine C Other Date:12/27/01ISR Number: 3845138-2Report Type:Expedited (15-DaCompany Report #US_011278464 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa Health (Olanzapine) PS 20 MG/DAY Professional Wintermin Company (Chlorpromazine Representative Hydrochloride) C Other Levotomin (Levomepromazine Maleate) C Halcion (Triazolam) C Tasmolin (Biperiden) C Proheparum C Date:12/27/01ISR Number: 3845139-4Report Type:Expedited (15-DaCompany Report #US_011075008 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Completed Suicide Health Hirnamin Hypochondriasis Professional (Levomepromazine) C Obsessive Thoughts Company Akineton (Biperiden Stress Representative Hydrochloride) C Suppressed Lactation Other Rohypnol (Flunitrazepam) C Serenace (Haloperidol) C Wintermin (Chlorpromazine Hydrochloride) C Pursennid (Senna Leaf) C Olopatadine Hydrochloride C 24-Jun-2005 12:19 PM Page: 1726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845140-0Report Type:Expedited (15-DaCompany Report #US_011178209 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Hospitalization - Condition Aggravated Health (Olanzapine) Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) PS 15 MG/DAY Diabetic Hyperosmolar Company Timiperone C Coma Representative Biperiden C Hepatocellular Damage Other Sepazon (Cloxazolam) C Hyperlipidaemia Lipantil Parkinsonism (Fenofibrate) C Weight Increased Date:12/27/01ISR Number: 3845141-2Report Type:Expedited (15-DaCompany Report #GBS011209824 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Foreign Zyprexa Face Oedema Health (Olanzapine) PS 5 MG/DAY Mental Impairment Professional Citalopram C Mobility Decreased Other Zopiclone C Diazepam C Bactroban (Mupirocin) C Lorazepam C Date:12/27/01ISR Number: 3845142-4Report Type:Expedited (15-DaCompany Report #GBS011209836 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Duodenal Ulcer Foreign Zyprexa Perforation Health (Olanzapine) PS 20 MG/DAY Haemorrhoids Professional Myocardial Infarction Other Date:12/27/01ISR Number: 3845143-6Report Type:Expedited (15-DaCompany Report #DE_011007024 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa Drug Interaction Health (Olanzapine) PS 10 MG/IN THE Menorrhagia Professional EVENING Schizophrenia, Paranoid Other Valette C Type Date:12/27/01ISR Number: 3845144-8Report Type:Expedited (15-DaCompany Report #AU_011204499 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Olanzapine PS 2.5 MG/DAY Initial or Prolonged Femoral Neck Fracture Study Zoloft (Sertraline Health Hydrochloride) C Professional Quinate (Quinine Other Sulfate) C 24-Jun-2005 12:19 PM Page: 1727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845151-5Report Type:Expedited (15-DaCompany Report #US_011278481 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholinesterase Foreign Zyprexa-Oral Increased Health (Olanzapine) Delusion Professional (Olanzapine) PS 10 MG/DAY Depressed Level Of Company Depakene (Valproate Consciousness Representative Sodium) C Drug Toxicity Other Zantac (Ranitidine Dysarthria Hydrochloride) C Pyrexia Methycobal Tremor (Mecobalamin) C Urinary Tract Infection Aplace (Troxipide) C Loxonin (Loxoprofen Sodium) C Chloramphenicol C Luvox (Fluvoxamine Maleate) C Zolpidem C Depas (Etizolam) C Serenace (Haloperidol) C Date:12/27/01ISR Number: 3845152-7Report Type:Expedited (15-DaCompany Report #US_011278604 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Artane Representative (Trihexyphenidyl Other Hydrochloride) C Lexotan (Bromazepam) C Date:12/27/01ISR Number: 3845247-8Report Type:Expedited (15-DaCompany Report #2015279 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Oxycodone Convulsion Professional Hydrochloride Coronary Artery Other (Similar To Nda Atherosclerosis 20-553) PS Hypertensive Heart Citalopram SS Disease Olanzapine SS Pulmonary Congestion Pulmonary Hypertension Toxicologic Test Abnormal Date:12/27/01ISR Number: 3845506-9Report Type:Expedited (15-DaCompany Report #USA011210215 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Propoxyphene Initial or Prolonged Lethargy Professional Napsylate-With Acetaminophen PS Zyprexa-Oral (Olanzapine) 24-Jun-2005 12:19 PM Page: 1728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS 15 MG/DAY Neurontin (Gabapentin) C Claritin (Loratadine) C Aricept (Donepezil Hydrochloride) C Trazodone C Remeron (Mirtazapine) C Transderm-Scop (Hyoscine) C Date:12/27/01ISR Number: 3845527-6Report Type:Expedited (15-DaCompany Report #US_011177641 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Zyprexa-Oral Initial or Prolonged Blood Albumin Decreased Professional (Olanzapine) Other Blood Parathyroid Hormone (Olanzapine) PS 5 MG/DAY Decreased Pravachol Blood Phosphorus (Pravastatin Sodium) C Increased Flovent (Fluticasone Hypocalcaemia Propionate) C Lasix (Furosemide) C Prednisone C Depakote (Valproate Semisodium) C Date:12/27/01ISR Number: 3845604-XReport Type:Expedited (15-DaCompany Report #US_010872415 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Discomfort Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - Agranulocytosis Health Serenace Initial or Prolonged C-Reactive Protein Professional (Haloperidol) C Increased Company Contomin Chromosome Abnormality Representative (Chlorpromazine Delusion Other Hydrochloride) C Granulocytopenia Rohypnol Headache (Flunitrazepam) C Mental Disorder Levotomin Myelodysplastic Syndrome (Levomepromazepam Oral Soft Tissue Disorder Maleate) C Pancytopenia Benzalin Pyrexia (Nitrazepam) C Red Blood Cell Count Decreased Staphylococcal Infection Tongue Discolouration Vomiting White Blood Cell Count Decreased White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 1729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845609-9Report Type:Expedited (15-DaCompany Report #EWC011229288 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accommodation Disorder Foreign Zyprexa-Oral Hospitalization - Blood Pressure Decreased Health (Olanzapine) PS 20000 MG/DAY Initial or Prolonged Drug Toxicity Professional Other Dysarthria Other Hallucination, Visual Overdose Sleep Attacks Somnolence Speech Disorder Suicide Attempt Date:12/27/01ISR Number: 3845610-5Report Type:Expedited (15-DaCompany Report #EWC011129039 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Condition Aggravated Health (Olanzapine) Delusion Professional (Olanzapine) PS 15 MG/1 DAY Depression Company Drug Tolerance Representative Hallucination Other Hepatic Steatosis Overdose Date:12/27/01ISR Number: 3845611-7Report Type:Expedited (15-DaCompany Report #DE_011107392 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa-Oral Initial or Prolonged Hyponatraemia Health (Olanzapine) PS 10 MG/DAY Pneumonia Professional Rhabdomyolysis Other Tachyarrhythmia Date:12/27/01ISR Number: 3845612-9Report Type:Expedited (15-DaCompany Report #DE_011107208 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Dystonia Health Thombran (Trazodone Professional Hydrochloride) C Other Aricept (Donepezil Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Ass C Date:12/27/01ISR Number: 3845623-3Report Type:Expedited (15-DaCompany Report #FR_011200475 Age:41 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abortion Spontaneous Initial or Prolonged Complications Of Maternal 24-Jun-2005 12:19 PM Page: 1730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exposure To Therapeutic Drugs Maternal Drugs Affecting Foetus Report Source Product Role Manufacturer Route Dose Duration Pregnancy Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Norset (Mirtazapine) C Tegretol (Carbamazepine) C Date:12/27/01ISR Number: 3845632-4Report Type:Expedited (15-DaCompany Report #US_010871741 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Headache Health (Olanzapine)(Olanzap Insomnia Professional ine) PS 20 MG/DAY Irritability Company Risperdal Representative (Risperidone) C Other Hiberna (Promethazine Hydrochloride) C Depas (Etizolam) C Date:12/27/01ISR Number: 3845723-8Report Type:Expedited (15-DaCompany Report #US_010973442 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Zyprexa (Olanzapine) PS 20 MG/DAY 19 MON Confusional State Professional Parnate Dizziness (Tranylcypromine Hypotension Sulfate) C Joint Stiffness Klonopin Nervousness (Clonazepam) C Paralysis Topamax (Topiramate) C Somnolence Depakote (Valproate Syncope Semisodium) C Tremor Visual Disturbance Date:12/27/01ISR Number: 3845724-XReport Type:Expedited (15-DaCompany Report #US_010973641 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zyprexa-Oral Other Pneumonia Professional (Olanzapine) Respiratory Failure (Olanzapine) PS 10 MG/ 1 AT BEDTIME Amantadine C Date:12/27/01ISR Number: 3845730-5Report Type:Expedited (15-DaCompany Report #USA011210198 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zyprexa-Oral Therapeutic Professional (Olanzapine) Drug Toxicity (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 1731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845732-9Report Type:Expedited (15-DaCompany Report #USA011210150 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Propoxyphene Professional Napsylate-With Company Acetaminophen PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/DAY 3 WK Ultram (Tramadol Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:12/27/01ISR Number: 3845740-8Report Type:Expedited (15-DaCompany Report #US_011279183 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Health Zyprexa-(Oral) Diabetes Mellitus Professional (Olanzapine) Inadequate Control (Olanzapine) PS ORAL (ORAL) Electrocardiogram Qt Prozac-(Oral) Corrected Interval (Fluoxetine) Prolonged (Fluoxetine Hydrochloride) SS ORAL (ORAL) : 60 MG/1 DAY Insulin C Date:12/27/01ISR Number: 3845741-XReport Type:Expedited (15-DaCompany Report #USA011210161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Consumer Zyprexa-(Oral) Therapeutic (Olanzapine) Imprisonment (Olanzapine) PS ORAL (ORAL) Date:12/27/01ISR Number: 3845764-0Report Type:Expedited (15-DaCompany Report #USA011210231 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypersensitivity Health Zyprexa-Oral Professional (Olanazpine) Company (Olanzapine) PS Representative Date:12/27/01ISR Number: 3845765-2Report Type:Expedited (15-DaCompany Report #USA011210248 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 10 MG/2 Divalproex Sodium C Benztropine C Haloperidol C 24-Jun-2005 12:19 PM Page: 1732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845768-8Report Type:Expedited (15-DaCompany Report #USA011210179 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Zyprexa-Oral Life-Threatening Influenza Like Illness Health (Olanzapine) Hospitalization - Loss Of Consciousness Professional (Olanzapine) PS Initial or Prolonged Pain Celexa (Citalopram Other Pyrexia Hydrobromide) C Sinusitis Tremor Date:12/27/01ISR Number: 3845831-1Report Type:Expedited (15-DaCompany Report #DE_011207578 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral Health (Olanzapine)(Olanzap Professional ine) PS 5 MG/DAY Other Remergil (Mirtazapine) C Date:12/27/01ISR Number: 3845832-3Report Type:Expedited (15-DaCompany Report #DE_011207577 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral(Olanzap Health ine)(Olanzapine) PS 10 MG/DAY Professional Ergenyl(Valproate Other Sodium) C Cipramil(Citalopram Hydrobromide) C Date:12/27/01ISR Number: 3845833-5Report Type:Expedited (15-DaCompany Report #EWC011229322 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Leukopenia Foreign Olanzapine-Oral Health (Olanzapine) PS 10 MG/DAY Professional Other Date:12/27/01ISR Number: 3845834-7Report Type:Expedited (15-DaCompany Report #CA_011104509 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatic Carcinoma Foreign Zyprexa(Olanzapine) PS 5 MG DAY Consumer Epival(Valproate Health Semisodium) C Professional Lithyrofine C Company Centrum C Representative Benstropen C Other Motrin(Ibuprofen) C Fluoanol C 24-Jun-2005 12:19 PM Page: 1733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845835-9Report Type:Expedited (15-DaCompany Report #DE_011107360 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Zyprexa-Oral Dyspnoea Health (Olanzapine)(Olanzap Sinus Tachycardia Professional ine) PS 20 MG/IN THE Other EVENING Date:12/27/01ISR Number: 3845838-4Report Type:Expedited (15-DaCompany Report #DE_011207520 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glucose Tolerance Test Foreign Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine)(Olanzap Professional ine) PS 10 MG/DAY Other Date:12/27/01ISR Number: 3845843-8Report Type:Expedited (15-DaCompany Report #US_011279034 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Zyprexa-Oral Cerebral Infarction Health (Olanzapine) Incontinence Professional (Olanzapine) PS 5 MG/DAY Overdose Company Oxygen Saturation Representative Decreased Other Somnolence Date:12/27/01ISR Number: 3845845-1Report Type:Expedited (15-DaCompany Report #GBS011209845 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Prozac-Oral Initial or Prolonged Increased Health (Fluoxetine) Disability Circulatory Collapse Professional (Fluoxetine Other Fatigue Other Hydrochloride) PS 20 MG/DAY Guillain-Barre Syndrome Zyprexa-Oral Lethargy (Olanzapine) Nausea (Olanzapine) SS 10 MG/DAY Neutropenia Vomiting Date:12/27/01ISR Number: 3845846-3Report Type:Expedited (15-DaCompany Report #DE_011207597 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral PS 5 MG/DAY Health Dominal Professional (Prothipendyl Other Hydrochloride) C Ass C Ximovan (Zopiclone) C 24-Jun-2005 12:19 PM Page: 1734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/01ISR Number: 3845869-4Report Type:Expedited (15-DaCompany Report #GBS010909482 Age:0 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Aplasia Foreign Zyprexa (Olanzapine) PS Congenital Hypothyroidism Health Sertraline C Maternal Drugs Affecting Professional Foetus Company Thyroid Malformation Representative Other Date:12/27/01ISR Number: 3845945-6Report Type:Expedited (15-DaCompany Report #EWC000506572 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Catatonia Literature (Olanzapine) Cholinergic Syndrome Health (Olanzapine) PS 10 MG/DAY Hallucination, Auditory Professional Xanax (Alprazolam) C Head Injury Other Sufenta (Sufentanil Hypertension Citrate) C Hypertonia Morphine C Hyponatraemia Speciafoldine (Folic Injury Acid) C Loss Of Consciousness Parkinane Multiple Fractures (Trihexyphenidyl Rash Hydrochloride) C Road Traffic Accident Salivary Hypersecretion Sinus Tachycardia Stupor Tachypnoea Tremor Date:12/28/01ISR Number: 3846509-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE02553 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Ritaline(Methylpheni Initial or Prolonged Study date Hydrochloride) Health Tablet PS ORAL SEE IMAGE Professional Zyprexa(Olanzapine) SS ORAL SEE IMAGE Other Aricept(Donepezil Hydrochloride) SS ORAL SEE IMAGE Thrombran(Trazodone Hydrochloride) C Acetylsalicylate C Date:12/28/01ISR Number: 3846713-1Report Type:Expedited (15-DaCompany Report #A122469 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Digeorge'S Syndrome Foreign Zoloft Tablets PS ORAL 50.00 MG Maternal Drugs Affecting Health TOTAL:DAILY:O Foetus Professional RAL Pregnancy Olanzapine SS ORAL 15.00 MG TOTAL:DAILY:O RAL 24-Jun-2005 12:19 PM Page: 1735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/01ISR Number: 3846741-6Report Type:Expedited (15-DaCompany Report #A129860 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Zoloft Tablets PS ORAL 50.00 MG Exposure To Therapeutic Health TOTAL: ORAL Drugs Professional Zyprexa (Olanzapine) SS ORAL 15.00 MG Digeorge'S Syndrome Other TOTAL: DAILY: Maternal Drugs Affecting ORAL Foetus Pregnancy Date:12/31/01ISR Number: 3845970-5Report Type:Direct Company Report #CTU 157950 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Zyprexa (Olanzapine) Intervention to (20mg ) PS ORAL 20MG PO QD Prevent Permanent Prozac C Impairment/Damage Date:12/31/01ISR Number: 3846075-XReport Type:Direct Company Report #CTU 158001 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Olanzapine (Zyprexa) PS 2.5-5 MG QD Initial or Prolonged Generalised Oedema Multi-Vitamin C Hepatitis Asa C Alcohol C Date:01/04/02ISR Number: 3848246-5Report Type:Periodic Company Report #01-05-0257 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozapine Hospitalization - Professional Tablets-Ivax Initial or Prolonged Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 650MG QD ORAL Depakote Tablets SS ORAL 1000 MG QD ORAL Zyprexa Tablets SS ORAL 30MG QD ORAL Lorazepam C Date:01/04/02ISR Number: 3849566-0Report Type:Expedited (15-DaCompany Report #PHRM2001FR01992 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Antidiuretic Foreign Ludiomil Initial or Prolonged Hormone Increased Health (Maprotiline Cerebral Ischaemia Professional Hydrochloride) Coma Other Tablet PS ORAL ORAL Convulsion Deroxat (Paroxetine Hyponatraemia Hydrochloride) SS ORAL ORAL Nausea Zyprexa (Olanzapine) Pituitary Tumour Benign Tablet SS ORAL ORAL Vomiting Seresta (Oxazepam) 24-Jun-2005 12:19 PM Page: 1736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablet C Temesta Tablet C Buspar (Buspirone Hydrochloride) Tablet C Veratran (Clotiazepam) Tablet C Tercian (Cyamemazine) Tablet C Date:01/07/02ISR Number: 3849062-0Report Type:Direct Company Report #CTU 158491 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Haloperidol PS .5MG BID Initial or Prolonged Syndrome Olanzapine SS 2.5MG QD Date:01/07/02ISR Number: 3849399-5Report Type:Expedited (15-DaCompany Report #A130101 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Zyrtec Tablets PS ORAL 10.00 MG Intervention to Asthenia Professional TOTAL; DAILY; Prevent Permanent Drug Interaction ORAL Impairment/Damage Loss Of Consciousness Parnate SS ORAL 60.00 MG Sedation TOTAL; DAILY; ORAL Zyprexa SS ORAL ORAL Neurontin C Trazodone C Date:01/07/02ISR Number: 3852795-3Report Type:Expedited (15-DaCompany Report #2001-12-0997 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Intron A (Interferon Initial or Prolonged Professional Alfa-2b Recombinant) Company Injectable PS Representative Zyprexa (Olanzapine) SS Serzone SS Date:01/08/02ISR Number: 3849930-XReport Type:Expedited (15-DaCompany Report #2001-11-1906 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Trilafon Tablets Hospitalization - Sudden Death Health (Perphenazine) PS ORAL 8 MG DAY ORAL Initial or Prolonged Professional Zoloft Tablets SS ORAL 100 MG DAY Other ORAL Zyprexa (Olanzapine) Tablets SS ORAL 7.5 MG DAY ORAL Pamol C 24-Jun-2005 12:19 PM Page: 1737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/02ISR Number: 3849957-8Report Type:Expedited (15-DaCompany Report #US_011279573 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Date:01/08/02ISR Number: 3849961-XReport Type:Expedited (15-DaCompany Report #US_011279034 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa-Oral Life-Threatening Brain Stem Infarction Health (Olanzapine) Hospitalization - Cerebral Infarction Professional (Olanzapine) PS 5 MG/DAY Initial or Prolonged Depressed Level Of Company Consciousness Representative Dizziness Other Electroencephalogram Abnormal Faecal Incontinence Oxygen Saturation Decreased Soliloquy Somnolence Urinary Incontinence Date:01/08/02ISR Number: 3849962-1Report Type:Expedited (15-DaCompany Report #US_011178274 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Mood Foreign Zyprexa-Oral Initial or Prolonged Lower Limb Fracture Health (Olanzapine) PS ORAL 20 MG/DAY Other Suicide Attempt Professional Trihexyphenidyl C Company Sennoside A C Representative Benzodiazepine C Other Date:01/08/02ISR Number: 3849983-9Report Type:Expedited (15-DaCompany Report #CA_011204627 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa Oral Initial or Prolonged Weight Increased Health (Olanzapine) PS 5 MG 10 MON Professional Company Representative Other Date:01/08/02ISR Number: 3850145-XReport Type:Expedited (15-DaCompany Report #US_020179689 Age:23 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Condition Aggravated Delusion Extrapyramidal Disorder 24-Jun-2005 12:19 PM Page: 1738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Laceration Pica Self Injurious Behaviour Report Source Product Role Manufacturer Route Dose Duration Suicide Attempt Foreign Olanzapine-Oral Study (Olanzapine) PS 15 MG DAY Health Impromen(Bromperidol Professional ) C Other Akineton(Biperiden Hydrochloride) C Levotomin(Levomeprom azine Maleate) C Hiberna(Promethazine Hydrochloride) C Lendormin(Brotizolam ) C Rohypnol(Flunitrazep am) C Meilax(Ethyl Loflazepate) C Sulpiride C Magnesium Oxide C Doral (Quazepam) C Tandospirone Citrate (Sediel) C Parlodel(Bromocripti ne Mesilate) C Valerin(Valproate Sodium) C Depas(Etizolam) C Date:01/08/02ISR Number: 3850254-5Report Type:Expedited (15-DaCompany Report #US_011279633 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Olanzapine-Oral PS ORAL 20 MG DAY Initial or Prolonged Condition Aggravated Study Rohypnol Persecutory Delusion Health (Flunitrazepam) C Psychiatric Symptom Professional Somnolence Other Date:01/08/02ISR Number: 3850256-9Report Type:Expedited (15-DaCompany Report #EWC011229288 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Zyprexa-Oral) Hospitalization - Dissociation Health (Olanzapine) PS 20000 MG/DAY Initial or Prolonged Drug Toxicity Professional Other Hallucination, Visual Other Heart Rate Increased Intentional Misuse Memory Impairment Sedation Somnolence Speech Disorder Suicide Attempt 24-Jun-2005 12:19 PM Page: 1739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/02ISR Number: 3850568-9Report Type:Direct Company Report #CTU 158678 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Ph Decreased Olanzepine 20mg PS ORAL 20MG QD ORAL Diabetic Hyperosmolar Hydrochlorothiazide C Coma Benazepril C Hypoxia Rhabdomyolysis Sepsis Date:01/08/02ISR Number: 3850831-1Report Type:Expedited (15-DaCompany Report #US_011176762 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Increased Health Dogmatyl (Sulpiride) C Aspartate Professional Lodopin (Zotepine) C Aminotransferase Company Linton (Haloperidol) C Increased Representative Tasmolin(Biperiden) C Haematocrit Decreased Other Hiberna(Promethazine Haemoglobin Decreased Hydrochloride) C Platelet Count Decreased Penselin Red Blood Cell Count (Dipyridamole) C Decreased Silece(Flunitrazepam White Blood Cell Count ) C Decreased Tinelac(Sennoside A+B) C Date:01/10/02ISR Number: 3851417-5Report Type:Expedited (15-DaCompany Report #2014869 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Oxycodone Coronary Artery Professional Hydrochloride Atherosclerosis Other (Similar To Nda Depression 20-553) PS Drug Toxicity Citalopram SS Injection Site Dextromethorphan SS Haemorrhage Propoxyphene SS Sternal Fracture Olanzapine SS Metoprolol SS Date:01/10/02ISR Number: 3851748-9Report Type:Periodic Company Report #US_001052448 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Study Nortriptyline Initial or Prolonged Health (Nortriptyline Professional Hydrochloride) PS 100 MG Company Olanzapine SS 12 MG/1 DAY Representative Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG/1 DAY Nitro Patch (Glyceryl Trinitrate) C Zocor (Simvastatin) C Folic Acid C 24-Jun-2005 12:19 PM Page: 1740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/02ISR Number: 3851805-7Report Type:Expedited (15-DaCompany Report #2001-12-0997 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Intron A (Interferon Initial or Prolonged Professional Alfa-2b Recombinant) Company Injectable Solution PS SUBCUTANEOUS 3 MU TIW Representative SUBCUTANEOUS Rebetol (Ribavirin) Capsules SS ORAL 1200 MG QD ORAL Zyprexa (Olanzapine) SS Serzone SS Effexor(Venlafaxine Hcl) C Elavil C Wellbutrin (Bupropion) C Oxycontin (Oxycodone Hcl) C Neurontin C Synthroid C Prilosec C Fiorinal C Buspar C Soma C Inderal C Date:01/14/02ISR Number: 3852003-3Report Type:Direct Company Report #CTU 159020 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:01/16/02ISR Number: 3853894-2Report Type:Direct Company Report #CTU 159502 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Olanzapine 5mg PS ORAL 5 MG 1/2 BID Intervention to Dizziness ORAL Prevent Permanent Dyspnoea Citalopram 20 Mg SS ORAL 20 MG QD Impairment/Damage ORAL Simvastatin C Fosinopril C Nitroglycerin C Metoprolol C Date:01/16/02ISR Number: 3854035-8Report Type:Expedited (15-DaCompany Report #DE_011207662 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Other Breast Cancer Foreign Health Professional 24-Jun-2005 12:19 PM Page: 1741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:01/16/02ISR Number: 3854037-1Report Type:Expedited (15-DaCompany Report #US_011076156 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Fall Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Contomin Representative (Chlorpromazine Other Hydrochloride) C Risperdal (Risperidone) C Artane (Trihexyphenidyl Hydrochloride) C Tasmolin (Biperiden) C Selbex (Teprenone) C Levotomin (Levomepromazine Maleate) C Rohypnol (Flunitrazepam) C Seroquel C Date:01/17/02ISR Number: 3855670-3Report Type:Direct Company Report #CTU 159571 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Zyprexa 10mg Eli Diabetes Mellitus Lilly PS Eli Lilly 10MG Q HS 1 YR Non-Insulin-Dependent Zoloft C Protonix C Premarin C Date:01/22/02ISR Number: 3856680-2Report Type:Direct Company Report #CTU 159682 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Zyprexa 5mg And 15mg Dry Skin (Lilly) PS Lilly 5MG PO QAM & Electrocardiogram 15MG QPM 5 WK Abnormal Paxil 10mg (Smith Electrocardiogram Qrs Kline Beecham) SS Smithkline Beecham ORAL 10MG PO AT Complex Prolonged 8:00PM 5 WK Hyperhidrosis Dicyclomine C Pallor Clonazepam C Pulmonary Embolism Syncope Ventricular Fibrillation 24-Jun-2005 12:19 PM Page: 1742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/02ISR Number: 3856683-8Report Type:Direct Company Report #CTU 159684 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Zyprexa 7.5mg Circulatory Collapse (Lilly) PS Lilly ORAL 7.5MG PO Dizziness BID 4 MON Dyspnoea Diovan 80mg Hyperhidrosis (Novartis) SS Novartis ORAL 80MG PO ZAM 6 MON Pulmonary Embolism Hydrochlorothiazide Respiratory Rate 12.5mg SS ORAL 12.5MG PO Increased QAM 6 MON Tachycardia Date:01/22/02ISR Number: 3857588-9Report Type:Expedited (15-DaCompany Report #HQ0746310MAY2001 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Atrophy Health Efexor (Venlafaxine Optic Neuritis Professional Hydrochloride, Retinogram Abnormal Other Tablet) PS ORAL 112.5 MG 1X PER 1 DAY Effexor (Venlafaxine Hydrochloride, Tablet) SS ORAL 22 DAY Antabus (Disulfiram, Tablet) SS ORAL 1.2 G 1X PER 1 WK 1351 DAY Zyprexa(Olanzapine,) SS ORAL 15 MG 1X PER 1 DAY 228 DAY Akineton (Biperiden Lactate) C Tetracycline (Tetracycline) C Apodorm (Nitrazepam) C Sobril (Oxazepam) C Citodon (Codeine Phosphate/Paracetamo l) C Date:01/23/02ISR Number: 3856866-7Report Type:Direct Company Report #CTU 159740 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa 20 Mg Eli Disability Lilly PS Eli Lilly ORAL 20MG DAY ORAL / BUCCAL Date:01/23/02ISR Number: 3859941-6Report Type:Periodic Company Report #NSADSS2001029161 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL DAILY, ORAL Olanzapine (Olanzapine) SS ORAL DAILY, ORAL Perphenazine (Perphenazine) SS ORAL DAILY, ORAL 24-Jun-2005 12:19 PM Page: 1743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859945-3Report Type:Periodic Company Report #NSADSS2001030429 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperidone Initial or Prolonged (Risperidone) PS Zyprexa (Olanzapine) SS Date:01/23/02ISR Number: 3860031-7Report Type:Direct Company Report #CTU 159869 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Olanzepine(10mg) Initial or Prolonged Decreased Appetite Lilly PS Lilly 10MG QHS Required Dysarthria Intervention to Parkinsonism Prevent Permanent Renal Failure Acute Impairment/Damage Date:01/24/02ISR Number: 3859458-9Report Type:Expedited (15-DaCompany Report #FLUV00202000109 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Luvox (Fluvoxamine Initial or Prolonged Back Pain Professional Maleate) PS ORAL 50 MG BID PO, Convulsion 25 MG BID PO Rhabdomyolysis Zyprexa (Olanzapine) SS ORAL 2.5 MG DAILY PO, 1.25 MG DAILY PO Trileptal (Oxcarbazepine) C Clonapin (Clonazepam) C Diamox (Acetazolamide) C Phenergan (Promethazine Hydrochloride) C Date:01/24/02ISR Number: 3859566-2Report Type:Direct Company Report #CTU 159978 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Zyprexa 5mg Intervention to Diabetes Mellitus Tablets / Lilly PS Lilly ORAL 5 MG, QHS, PO Prevent Permanent Fatigue Naproxen C Impairment/Damage Hunger Oxymetazoline C Nocturia Sertraline C Polyuria Gabapentin C Thirst Weight Increased Date:01/25/02ISR Number: 3858547-2Report Type:Direct Company Report #CTU 160117 Age:79 YR Gender:Female I/FU:I Outcome PT Other Dry Skin Erythema 24-Jun-2005 12:19 PM Page: 1744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Report Source Product Role Manufacturer Route Dose Duration Zyprexa PS 2.5 MG BID 2T QHS Vicodin C Zoloft C Date:01/25/02ISR Number: 3860063-9Report Type:Expedited (15-DaCompany Report #GBS020109946 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Zyprexa L Electrocardiogram Qt Health (Olanzapine) PS ORAL 5 MG Prolonged Professional Aspirin C Other Isosorbide Mononitrate C Amlodipine C Date:01/25/02ISR Number: 3860066-4Report Type:Expedited (15-DaCompany Report #EWC020129597 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 40 MG/DAY Aminotransferase Other Insidon (Opipramol Increased Hydrochloride) C Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Dry Skin Exanthem Eyelid Oedema Haemangioma Inflammation Leukopenia Pyrexia Thrombocytopenia Date:01/25/02ISR Number: 3860070-6Report Type:Expedited (15-DaCompany Report #AU_020104586 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa Health (Olanzapine) PS 5 MG/DAY Professional Aropax (Paroxetine Other Hydrochloride) C Date:01/25/02ISR Number: 3860098-6Report Type:Expedited (15-DaCompany Report #EWC010727733 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Autoimmune Disorder Initial or Prolonged Diabetes Mellitus Disability Inadequate Control 24-Jun-2005 12:19 PM Page: 1745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Report Source Product Role Manufacturer Route Dose Duration Hepatic Steatosis Foreign Olanzapine PS 15 MG/DAY Hepatitis Health Deroxat (Paroxetine Platelet Count Increased Professional Hydrochloride) C Renal Impairment Company Renal Tubular Disorder Representative Weight Increased Other Date:01/25/02ISR Number: 3860101-3Report Type:Expedited (15-DaCompany Report #US_020180048 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Olanzapine-Oral Other Cerebral Infarction Study (Olanzapine) PS 10 MG DAY White Blood Cell Count Health Isosorbide Dinitrate C Increased Professional Eurodin (Estazolam) C Other Hiberna (Promethazine Hydrochloride) C Lendormin (Brotizolam) C Ganaton (Fm) (Ganaton (Fm)) C Laxoberon (Sodium Picosulfate) C Senna Liquid Extract C Impromen (Bromperidol) C Calslot (Manidipine Hydrochloride) C Cetapril (Alacepril) C Panaldine (Ticlopidine Hydrochloride) C Date:01/25/02ISR Number: 3860117-7Report Type:Expedited (15-DaCompany Report #GBS020109962 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glossitis Foreign Zyprexa-Oral Oral Discomfort Health (Olanzapne) Stomatitis Professional (Olanzapine) PS 5 MG/DAY Other Procyclidine C Date:01/25/02ISR Number: 3860196-7Report Type:Expedited (15-DaCompany Report #US_020180121 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Study (Olanzapine) PS 12 MG/2 DAY Health Fluoxetine-Oral Professional (Fluoxetine) Other (Fluoxetine Hydrochlor SS 50 MG AT BEDTIME Lorazepam C 24-Jun-2005 12:19 PM Page: 1746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/02ISR Number: 3860246-8Report Type:Direct Company Report #USP 54715 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Zyrtec PS Pfizer Hypersomnia Zyprexa SS Lilly Loss Of Consciousness Medication Error Mixed Connective Tissue Disease Nausea Pulmonary Oedema Date:01/25/02ISR Number: 3860495-9Report Type:Expedited (15-DaCompany Report #FR_011000294 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Zyprexa-Oral Cytolytic Hepatitis Health (Olanzapine) Hepatic Steatosis Professional (Olanzapine) PS 20 MG/DAY Weight Increased Other Mopral (Omeprazole) C Lysanxia (Prazepam) C Lipanthyl (Fenofibrate) C Date:01/25/02ISR Number: 3860496-0Report Type:Expedited (15-DaCompany Report #DE_020107710 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Oral Initial or Prolonged Lower Respiratory Tract Health (Olanzapine) Infection Professional (Olanzapine) PS 15 MG/DAY Pyrexia Other Carbimazole C Stomatitis Necrotising Date:01/25/02ISR Number: 3860713-7Report Type:Expedited (15-DaCompany Report #A127092 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Consumer Zoloft Tablets PS ORAL 50.00 MG Intervention to Anger Health TOTAL:DAILY:O Prevent Permanent Difficulty In Walking Professional RAL Impairment/Damage Feeling Abnormal Zyprexa SS ORAL 5.00 MG Illusion TOTAL:DAILY:O Visual Disturbance RAL Reminyl C Vitamin E C Vitamin C C Vitamin D C Date:01/25/02ISR Number: 3860714-9Report Type:Expedited (15-DaCompany Report #2002AP00158 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Quetiapine PS Toxicologic Test Abnormal Health Sertraline SS Professional Olanzapine SS Ephedrine C 24-Jun-2005 12:19 PM Page: 1747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pseudoephedrine C Date:01/25/02ISR Number: 3860754-XReport Type:Expedited (15-DaCompany Report #US_020180026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Olanzapine-Oral Initial or Prolonged Depressed Level Of Health (Olanzapine) PS 20 MG/DAY Other Consciousness Professional Quetiapine C Diabetes Mellitus Valproate Sodium C Glycosylated Haemoglobin Clonazepam C Increased ... C Hypoglycaemia Overdose Psychotic Disorder Sedation Suicide Attempt Weight Increased Date:01/25/02ISR Number: 3861445-1Report Type:Expedited (15-DaCompany Report #US94084090A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anion Gap Increased Study Zyprexa-Oral Hospitalization - Blood Insulin Increased Literature (Olanzapine) Initial or Prolonged Body Mass Index Increased Health (Olanzapine) PS 20 MG / 1 DAY Diabetes Mellitus Professional Ativan (Lorazepam) C Diabetic Ketoacidosis Glycosylated Haemoglobin Increased Insulin C-Peptide Increased Ketosis Weight Decreased Date:01/25/02ISR Number: 3861496-7Report Type:Expedited (15-DaCompany Report #US_011076452 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Humulin-Human Cerebrovascular Accident Health Insulin(Rdna): 30% Crying Professional Regular, 70% Nph PS 7 YR Diabetes Mellitus Prozac-Oral Inadequate Control (Fluoxetine) Feeling Abnormal (Fluoxetine Fibromyalgia Hydrochloride) SS Mood Swings Zyprexa-Oral Muscular Weakness (Olanzapine) Myocardial Infarction (Olanzapine) SS 2.5 MG/DAY Screaming Humalog-. (Lispro) SS 7 DAY Sedation Glucophage(Metformin Sleep Walking Hydrochloride) C Swelling Actos "Takeda" (Pioglitazone) C Klor-Con(Potassium Chloride) C Furosemide C Prednisone C 24-Jun-2005 12:19 PM Page: 1748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coumadin(Warfarin Sodium) C Temazepam C Hyzaar C Tylenol(Paracetamol) C Oxycontin(Oxycodone Hydrochloride) C Vioxx (Refecoxib) C Norvasc(Amlodipine Besilate) C Venlafaxine C Date:01/28/02ISR Number: 3859827-7Report Type:Expedited (15-DaCompany Report #US_011177637 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa-Oral Professional (Olanzapine) (Olanazapine) PS 20 MG/1 DAY/A FEW YEARS Desipramine C Carbamazepine C Date:01/28/02ISR Number: 3859828-9Report Type:Expedited (15-DaCompany Report #US_010668104 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Consumer Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Date:01/28/02ISR Number: 3860415-7Report Type:Direct Company Report #CTU 160214 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arthralgia Olanzapine 15mg Intervention to Myalgia Tablet - Lilly PS Lilly ORAL 15 PO DAILY Prevent Permanent Impairment/Damage Date:01/28/02ISR Number: 3860418-2Report Type:Direct Company Report #CTU 160218 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Zyprexa PS 2.5MG HS Tardive Dyskinesia Tegretol C Depakote C Celexa C Klonopin C Norvasc C Toprol C 24-Jun-2005 12:19 PM Page: 1749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/02ISR Number: 3861282-8Report Type:Expedited (15-DaCompany Report #EWC010326024 Age:0 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anomaly Of External Ear Foreign Zyprexa-Oral Congenital Health (Olanzapine) Caesarean Section Professional (Olanzapine) PS 6 MON Congenital Anomaly Other Tranxene Foetal Distress Syndrome (Clorazepate Maternal Drugs Affecting Dipotassium) C Foetus Pregnancy Small For Dates Baby Date:01/28/02ISR Number: 3861284-1Report Type:Expedited (15-DaCompany Report #GBS010909511 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Epilepsy Health Prozac (Fluoxetine Schizoaffective Disorder Professional Hydrochloride) C Other Date:01/28/02ISR Number: 3861286-5Report Type:Expedited (15-DaCompany Report #AU_011204499 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Olanzapine-Oral Initial or Prolonged Fall Study (Olanzapine) PS 2.5 MG/DAY Femoral Neck Fracture Health Zoloft (Sertraline Professional Hydrochloride) C Other Quinate (Quinine Sulfate) C Date:01/28/02ISR Number: 3861287-7Report Type:Expedited (15-DaCompany Report #CA_011104509 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa-Oral Initial or Prolonged Jaundice Consumer (Olanzapine) Other Jaundice Cholestatic Health (Olanzapine) PS 5 MG DAY Pancreatic Carcinoma Professional Epival (Valproate Company Semisodium) C Representative L-Thyroxine C Other Centrum C Benztropine C Motrin (Ibuprofen) C Fluanxol (Flupentixol Dihydrochloride) C Lithium Carbonate C Wellbutrin (Amfebutamone Hydrochloride) C Desyrel (Trazodone Hydrochloride) C Desipramine C Trazodone C Synthroid 24-Jun-2005 12:19 PM Page: 1750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine Sodium) C Flupentixol C Voltaren (Diclofenac Sodium) C Lorazepam C Tylenol (Paracetamol) C Tylenol W/Codeine No. 3 C Date:01/29/02ISR Number: 3860801-5Report Type:Direct Company Report #CTU 160408 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Zyprexa 2.5mg Lilly PS Lilly ORAL 2.5MG ONCE Anger DAILY ORAL Condition Aggravated Drug Effect Decreased Mania Date:01/29/02ISR Number: 3860811-8Report Type:Direct Company Report #CTU 160411 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa PS Hospitalization - Hypokalaemia Cardura C Initial or Prolonged Hyponatraemia Augmentin C Required Lethargy Elavil C Intervention to Pollakiuria Oxazepam C Prevent Permanent Polydipsia Impairment/Damage Date:01/30/02ISR Number: 3862597-XReport Type:Expedited (15-DaCompany Report #US_020179689 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laceration Foreign Olanzapine-Oral Initial or Prolonged Pica Study (Olanzapine) PS 15 MG DAY Self Injurious Behaviour Health Impromen Suicide Attempt Professional (Bromperidol) C Other Akineton (Biperiden Hydrochloride) C Hibernia (Promethazine Hydrochloride) C Rohypnol (Flunitrazepam) C Meilax (Ethyl Loflazepate) C Sulpiride C Magensium Oxide C Doral (Quazepam) C Tandospirone Citrate (Sediel) C Parlodel (Bromocriptine Mesilate) C Depas (Etizolam) C 24-Jun-2005 12:19 PM Page: 1751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/02ISR Number: 3862599-3Report Type:Expedited (15-DaCompany Report #GBS011209836 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa-Oral Hospitalization - Abdominal Pain Upper Health (Olanzapine) Initial or Prolonged Duodenal Ulcer Professional (Olanzapine) PS 15 MG/DAY Perforation Other Faecal Occult Blood Positive Haemoglobin Decreased Myocardial Infarction Protein Total Decreased Rectal Haemorrhage Upper Gastrointestinal Haemorrhage Date:01/30/02ISR Number: 3862630-5Report Type:Expedited (15-DaCompany Report #EWC010526798 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Foreign Zyprexa-Oral Vision Blurred Health (Olanzapine) Visual Disturbance Professional (Olanzapine) PS 15 MG/DAY Visual Field Defect Other Effexor (Venlafaxine Hydrochloride) C Antabus (Disulfiram) C Akineton (Biperiden Hydrochloride) C Tetracycline "Nm Pharma" (Tetracycline Hydrochloride) C Apodorm (Nitrazepam) C Sobril (Oxazepam) C Citodon C Date:01/30/02ISR Number: 3862631-7Report Type:Expedited (15-DaCompany Report #DE_011207662 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Date:01/30/02ISR Number: 3862910-3Report Type:Expedited (15-DaCompany Report #US_010973910 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Consumer Zyprexa (Olanzapine) PS 7.5 MG/DAY Blood Cholesterol Klonopin Increased (Clonazepam) C Fatigue Avandia (Rosiglitazone Maleate) C Metformin C Glipizide C Synthroid 24-Jun-2005 12:19 PM Page: 1752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine Sodium) C Simvastatin C Colace (Docusate Sodium) C Multivitamin C Lantus (Insulin) C Vitamin C Date:01/30/02ISR Number: 3862911-5Report Type:Expedited (15-DaCompany Report #USA011210161 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Consumer Zyprexa-Oral Pulmonary Embolism (Olanzapine) (Olanzapine) PS Date:01/31/02ISR Number: 3861056-8Report Type:Expedited (15-DaCompany Report #B0134019A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mouth Haemorrhage Zyban PS Glaxo Wellcome ORAL 150MG As directed Fluoxetine SS ORAL 20MG Per day Olanzapine SS ORAL 7.5MG Unknown Loxapine SS ORAL 50MG Per day Mepronizine SS ORAL 2UNIT Per day Date:01/31/02ISR Number: 3862811-0Report Type:Expedited (15-DaCompany Report #US_991029836 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Lethargy Professional (Olanzapine) Somnolence Company (Olanzapine) PS 10 MG/1 DAY Weight Increased Representative Prolixin Decanoate White Blood Cell Count (Fluphenazine Increased Decanoate) C Date:01/31/02ISR Number: 3862812-2Report Type:Expedited (15-DaCompany Report #US_011176998 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Infarction Health Zyprexa-Oral Nuclear Magnetic Professional (Olanzapine) Resonance Imaging Brain (Olanzapine) PS 15MG/DAY A Abnormal FEW YEARS Wellbutrin (Amfebutamone Hydrochloride) C Synthroid (Levothyroxine Sodium) C Zestril (Lisinopril) C K-Dur (Potassium Chloride) C Hydrochlorothiazide C Lipitor 24-Jun-2005 12:19 PM Page: 1753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) C Aspirin C Date:01/31/02ISR Number: 3862814-6Report Type:Expedited (15-DaCompany Report #US_011177352 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Sinus Tachycardia Professional (Olanzapine) Company (Olanzapine) PS 600 MG/DAY Representative Neurontin (Gabapentin) C Effexor (Venlafaxine Hydrochloride) C Klonopin (Clonazepam) C Ativan (Lorazepam) C Thorazine (Chlorpromazine Hydrochloride) C Date:01/31/02ISR Number: 3862816-XReport Type:Expedited (15-DaCompany Report #USA020110403 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Date:01/31/02ISR Number: 3862817-1Report Type:Expedited (15-DaCompany Report #USA020110404 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 15 MG/DAY Date:01/31/02ISR Number: 3862908-5Report Type:Expedited (15-DaCompany Report #US_980910955 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Cerebrovascular Accident (Olanzapine) Decreased Activity (Olanzapine) PS 15 MG/DAY Diabetes Mellitus Serentil Fatigue (Mesoridazine) C Glycosylated Haemoglobin Metformin C Increased Glipizide C Sedation Zoloft (Sertraline Hydrochloride) C Klonopin (Clonazepam) C Simvastatin C Beconase (Beclometasone Dipropionate) C Vitamin E C Vitamin C C 24-Jun-2005 12:19 PM Page: 1754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lisinopril C Glyburide C Synthroid (Levothyroxine Sodium) C Colace (Docusate Sodium) C Multivitamin C Date:01/31/02ISR Number: 3862961-9Report Type:Expedited (15-DaCompany Report #DE_020107774 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Other Tavor (Lorazepam) C Remergil (Mirtazapine) C Remestan (Temazepam) C Date:01/31/02ISR Number: 3862970-XReport Type:Expedited (15-DaCompany Report #GBS020109990 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Foreign Zyprexa-Oral Antidiuretic Hormone Health (Olanzapine) Secretion Professional (Olanzapine) PS 20 MG/DAY Other Bendrofluazide C Date:01/31/02ISR Number: 3862999-1Report Type:Expedited (15-DaCompany Report #US_020180609 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa-Oral Other Cholangitis Health (Olanzapine) Cholelithiasis Professional (Olanzapine) PS 5 MG/DAY Pulse Absent Company Rohypnol Representative (Flunitrazepam) C Other Date:01/31/02ISR Number: 3863003-1Report Type:Expedited (15-DaCompany Report #GBS011209933 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Pressure Initial or Prolonged Fluctuation Body Temperature Increased Drug Level Increased Electrolyte Imbalance Hyperhidrosis Incontinence Leukocytosis Mental Status Changes Mutism Neuroleptic Malignant 24-Jun-2005 12:19 PM Page: 1755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Melleril Representative (Thioridazine Other Hydrochloride) C Lithium C Alprazolam C Cogentin (Benzatropine Mesilate) C Date:01/31/02ISR Number: 3863276-5Report Type:Expedited (15-DaCompany Report #USA020110453 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Health Zyprexa-Oral Initial or Prolonged Thrombocytopenic Purpura Professional (Olanzapine) (Olanzapine) PS 20 MG DAY 2 YR Lisinopril C Date:01/31/02ISR Number: 3863278-9Report Type:Expedited (15-DaCompany Report #US_020180581 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:01/31/02ISR Number: 3863280-7Report Type:Expedited (15-DaCompany Report #USA020110420 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 3 DAY Representative Date:01/31/02ISR Number: 3863283-2Report Type:Expedited (15-DaCompany Report #USA020110463 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS Representative Date:01/31/02ISR Number: 3863284-4Report Type:Expedited (15-DaCompany Report #FR_020100538 Age: Gender:Female I/FU:I Outcome PT Other Abortion Spontaneous Maternal Drugs Affecting 24-Jun-2005 12:19 PM Page: 1756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Foetus Pregnancy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Norset (Mirtazapine) C Tegretol (Carbamazepine) C Date:01/31/02ISR Number: 3863286-8Report Type:Expedited (15-DaCompany Report #FR_020100552 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytolytic Hepatitis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Stilnox (Zolpidem) C Date:01/31/02ISR Number: 3863287-XReport Type:Expedited (15-DaCompany Report #EWC020129663 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Zyprexa-Oral Hospitalization - Anorexia Health (Olanzapine) Initial or Prolonged Anuria Professional (Olanzapine) PS 10 MG/DAY Blood Bilirubin Increased Other Theralen Dyspnoea (Alimemazine Epistaxis Tartrate) C Gallbladder Disorder Imovane (Zopiclone) C Haematuria Acetylcysteine Hepatic Failure "Tika" Hepatitis (Acetylcysteine) C Hepatitis D Hepatorenal Syndrome Pyrexia Renal Failure Selective Iga Immunodeficiency Somnolence Vomiting Date:01/31/02ISR Number: 3863289-3Report Type:Expedited (15-DaCompany Report #EWC020129673 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Striae Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Remeron (Mirtazapine) C 24-Jun-2005 12:19 PM Page: 1757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/02ISR Number: 3863292-3Report Type:Expedited (15-DaCompany Report #DE_020107769 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Date:01/31/02ISR Number: 3863297-2Report Type:Expedited (15-DaCompany Report #GBS020110010 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/2 DAY Other Lormetazepam C Venlafaxine C Mirtazapine C Date:02/01/02ISR Number: 3863907-XReport Type:Expedited (15-DaCompany Report #2001AP05963 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Risperdal SS ORAL 12 MG DAILY Other PO Contomin SS ORAL 300 MG DAILY PO Zyprexa SS ORAL 5 MG DAILY PO Zyprexa SS ORAL 10 MG DAILY PO Levotomin C Artane C Tasmolin C Selbex C Rohypnol C Date:02/01/02ISR Number: 3864294-3Report Type:Expedited (15-DaCompany Report #2002CG00161 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Mopral PS ORAL 1 DF DAILY PO Initial or Prolonged Anxiety Health Zyprexa SS ORAL 5 MG DAILY PO Cerebral Ischaemia Professional Imovane SS ORAL 1 DF DAILY PO Cerebrovascular Accident Other Deroxat SS ORAL 1 DF DAILY PO Condition Aggravated Celebrex SS ORAL 1 DF DAILY PO Diarrhoea Tranxene 5 Mg SS ORAL 1 DF DAILY PO Disorientation Corvasal C Drug Ineffective Sinemet C Hallucination Hemiplegia 24-Jun-2005 12:19 PM Page: 1758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/02ISR Number: 3863751-3Report Type:Direct Company Report #CTU 160648 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Olanzapine 10 Mg Intervention to Phosphokinase Increased Lilly PS Lilly ORAL 10 MG BID Prevent Permanent Dehydration ORAL Impairment/Damage Hypotension Thioridazine 30mg/Ml SS ORAL 40 MG TID Neuroleptic Malignant ORAL Syndrome Carbamazepine C Pneumonia Benztropine C Pyrexia Lorazepam C Somnolence Date:02/05/02ISR Number: 3865743-7Report Type:Expedited (15-DaCompany Report #USA020110503 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Health Zyprexa-Oral Initial or Prolonged Rhabdomyolysis Professional (Olanzapine) Other Company (Olanzapine) PS 20 MG/DAY Representative Loxitane (Lixapine Succinate) C Neurontin (Gabapentin) C Adalat (Nifedipine) C Tenormin (Atenolol) C Lasix (Furosemide) C Potassium C Synthroid (Levothyroxine Sodium) C Colchicine C Allopurinol C Date:02/05/02ISR Number: 3865745-0Report Type:Expedited (15-DaCompany Report #USA020110510 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:02/05/02ISR Number: 3865746-2Report Type:Expedited (15-DaCompany Report #US_020181053 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Olanzapine- Oral Initial or Prolonged Diabetic Ketoacidosis Health (Olanzapine) PS 15 MG/DAY Hyperglycaemia Professional Valproic Acid C Insomnia Carbamazepan Glucose C Pancreatitis Anion Gap C Bicarbonate C Ph, Venous C Ua-Glucose C Hemoglobin A1c C Alcohol C Amylase C Lipase C 24-Jun-2005 12:19 PM Page: 1759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/02ISR Number: 3865748-6Report Type:Expedited (15-DaCompany Report #USA020110558 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Zyprexa-Oral Initial or Prolonged Pregnancy Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:02/05/02ISR Number: 3865751-6Report Type:Expedited (15-DaCompany Report #USA020110493 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Zyprexa-Oral Initial or Prolonged Thinking Abnormal (Olanzapine) Weight Increased (Olanzapine) PS 5 MG/TWICE DAY Date:02/05/02ISR Number: 3865753-XReport Type:Expedited (15-DaCompany Report #USA020110494 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Iron Decreased Consumer Zyprexa-Oral Fibroma (Olanzapine) Menorrhagia (Olanzapine) PS 2.5 MG/DAY Psychotic Disorder Red Blood Cell Count Decreased Date:02/05/02ISR Number: 3865754-1Report Type:Expedited (15-DaCompany Report #USA020110526 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Zyprexa-Oral Initial or Prolonged Chest Pain (Olanzapine) Fatigue (Olanzapine) PS 1.25 MG/AT Haemoglobin Decreased BEDTIME Multivitamin C Date:02/05/02ISR Number: 3865756-5Report Type:Expedited (15-DaCompany Report #USA020110563 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Zyprexa-Oral Initial or Prolonged Airways Disease Professional (Olanzapine) Exacerbated (Olanzapine) PS 5 MG/DAY Hyponatraemia Dapsone C Hypoxia Remeron (Mirtazapine) C Ms Contin (Morphine Sulfate) C Date:02/05/02ISR Number: 3865757-7Report Type:Expedited (15-DaCompany Report #USA020110549 Age:12 YR Gender: I/FU:I Outcome PT Report Source Epistaxis Health Professional 24-Jun-2005 12:19 PM Page: 1760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:02/05/02ISR Number: 3865826-1Report Type:Expedited (15-DaCompany Report #FR_020100563 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa Initial or Prolonged Increased Health (Olanzapine) PS 10 MG/DAY Aspartate Professional Tercian Aminotransferase Other (Cyamemazine) C Increased Havlane (Loprazolam Biliary Tract Disorder Mesilate) C Blood Alkaline Phosphatase Increased Cholestasis Gamma-Glutamyltransferase Increased Hyperbilirubinaemia Pruritus Date:02/05/02ISR Number: 3865875-3Report Type:Expedited (15-DaCompany Report #US_020181029 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Foreign Zyprexa-Oral Initial or Prolonged Palpitations Health (Olanzapine) PS 20 MG/DAY Other Petechiae Professional Lithium C Platelet Count Decreased Other Clonazepam C Salivary Gland Disorder Date:02/05/02ISR Number: 3865876-5Report Type:Expedited (15-DaCompany Report #US_020180702 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Foreign Zyprexa-Oral Initial or Prolonged Blood Urea Increased Health (Olanzapine) PS 10 MG/DAY Creatinine Renal Professional Serenace Clearance Increased Company (Haloperidol) C Representative Lendormin (Brotizolam) C Cercin (Diazepam) C Date:02/05/02ISR Number: 3865878-9Report Type:Expedited (15-DaCompany Report #DE_020107832 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral Neutrophil Count Health (Olanzapine) Decreased Professional (Olanzapine) PS 20 MG/DAY Other Remergil (Mirtazapine) C Tavor (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/02ISR Number: 3865880-7Report Type:Expedited (15-DaCompany Report #FR_020100595 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Other Blood Glucose Increased Health (Olanzapine) Fatigue Professional (Olanzapine) PS 20 MG/DAY Hyperglycaemia Company Oral Candidiasis Representative Urine Ketone Body Present Other Weight Increased Date:02/05/02ISR Number: 3865881-9Report Type:Expedited (15-DaCompany Report #EWC020129720 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Zyprexa-Oral Epilepsy Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Other Fenobarbital C Date:02/05/02ISR Number: 3865886-8Report Type:Expedited (15-DaCompany Report #FR_020100576 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Blood Creatinine Professional (Olanzapine) PS 2.5 MG/DAY Increased Company Blood Urea Increased Representative Dehydration Other Muscle Rigidity Pyrexia Date:02/05/02ISR Number: 3865887-XReport Type:Expedited (15-DaCompany Report #CA_020104677 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS Company Seroquel C Representative Other Date:02/05/02ISR Number: 3865889-3Report Type:Expedited (15-DaCompany Report #EWC020129743 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Granulocytopenia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Rivotril (Clonazepam) C 24-Jun-2005 12:19 PM Page: 1762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/02ISR Number: 3865890-XReport Type:Expedited (15-DaCompany Report #EWC020129740 Age:5 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Foreign Zyprexa-Oral Initial or Prolonged Foetal Disorder Health (Olanzapine) Congenital Anomaly Maternal Drugs Affecting Professional (Olanzapine) PS Foetus Company Frontin (Alprazolam) C Spina Bifida Representative Tegretol Other (Carbamazepine) C Date:02/05/02ISR Number: 3865893-5Report Type:Expedited (15-DaCompany Report #EWC020129680 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Health (Olanzapine) PS 10 MG/DAY Professional Other Date:02/05/02ISR Number: 3865894-7Report Type:Expedited (15-DaCompany Report #US_020180775 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Olanzapine-Oral Study (Olanzapine) PS 10 MG DAY Health Pursennid (Senna Professional Leaf) C Other Ferrous Sulfate C Date:02/05/02ISR Number: 3866376-9Report Type:Expedited (15-DaCompany Report #US_011279411 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ammonia Increased Foreign Zyprexa-Oral Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS 10 MG /DAY Diabetes Mellitus Company Wypax (Lorazepam) C Diabetic Hyperosmolar Representative Wintermin(Chloroprom Coma Other azine Hydrochloride) C Glucose Urine Present Aminoleban C Hypernatraemia Pansporin (Cefotiam Infection Hydrochloride) C Polyuria Cravit Pyrexia (Levofloxacin) C Vomiting Silece (Flunitrazepam) C Gaster (Famotidine) C Date:02/05/02ISR Number: 3866379-4Report Type:Expedited (15-DaCompany Report #DE_020107710 Age:50 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agranulocytosis Initial or Prolonged Bronchitis Jaw Disorder Osteomyelitis Pyrexia 24-Jun-2005 12:19 PM Page: 1763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stomatitis Necrotising Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Carbimazole C Date:02/05/02ISR Number: 3866381-2Report Type:Expedited (15-DaCompany Report #GBS020109978 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Olanzapine-Oral Coma Other (Olanzapine) PS 20 MG /1 AT Dyspnoea BEDTIME Chlorpromazine C Clomipramine C Procyclidine C Lorazepam C Date:02/05/02ISR Number: 3866383-6Report Type:Expedited (15-DaCompany Report #US_011076156 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Fall Health (Olanzapine) Professional (Olanzapine) PS 10 MG /DAY Company Contomin Representative (Chlorpromazine Other Hydrcochloride) C Risperdal(Risperidon e) C Artane (Trixhexyphenidyl Hydrochloride) C Tasmolin (Biperiden) C Selbex (Teprenone) C Levotomin (Levomepromazine Maleate) C Rohypnol (Flunitrazepam) C Seroquel C Date:02/05/02ISR Number: 3866385-XReport Type:Expedited (15-DaCompany Report #US_011279034 Age:58 YR Gender:Female I/FU:F Outcome PT Death Blood Pressure Decreased Life-Threatening Brain Stem Infarction Hospitalization - Cerebral Infarction Initial or Prolonged Depressed Level Of Consciousness Dizziness Faecal Incontinence Gastric Ulcer Moaning Oxygen Saturation 24-Jun-2005 12:19 PM Page: 1764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Pneumonia Pulse Pressure Decreased Screaming Report Source Product Role Manufacturer Route Dose Duration Soliloquy Foreign Zyprexa-Oral Somnolence Health (Olanzapine) Urinary Incontinence Professional (Olanzapine) PS 5 MG/DAY Company Representative Other Date:02/06/02ISR Number: 3865749-8Report Type:Expedited (15-DaCompany Report #USA020110473 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Lithium C Date:02/07/02ISR Number: 3867750-7Report Type:Expedited (15-DaCompany Report #2002SE00762 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 600 MG DAILY Overdose Health PO Professional Zyprexa SS LONG TERM Other TREATMENT Akineton SS Prozac SS Orfidal SS Trankimazin SS Date:02/13/02ISR Number: 3869457-9Report Type:Periodic Company Report #2012179 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) PS Diazepam SS Temazepam SS Olanzapine SS Meprobmate SS Paxil (Paroxetine) C Date:02/13/02ISR Number: 3870586-4Report Type:Periodic Company Report #2012646 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) PS Alprazolam SS Diphenhydramine SS Nicotine SS 24-Jun-2005 12:19 PM Page: 1765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine SS Barbiturate SS Benzodiazepine SS Salicylate SS Valproic Acid SS Gabapentin SS Butalbital SS Carisoprodol C Neurontin (Gabapentin) C Depakote (Divalproex Sodium) C Zyprexa C Viagra C Risperdal C Nystatin Cream Usp C Diphenhydramine C Date:02/13/02ISR Number: 3871041-8Report Type:Periodic Company Report #2012354 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Oxycodone Professional Hydrochloride PS Other Cocaine SS Promethazine SS Chlorpromazine SS Acetaminophen SS ORAL PO Ibuprofen SS ORAL PO Caffeine SS ORAL PO Olanzapine SS ORAL PO Date:02/13/02ISR Number: 3871045-5Report Type:Periodic Company Report #2012358 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride PS Other Ethanol SS ORAL PO Citalopram SS ORAL PO Olanzapine SS ORAL PO Caffeine SS PO Date:02/13/02ISR Number: 3871103-5Report Type:Periodic Company Report #2015056 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Oxycodone Professional Hydrochloride PS Other Morphine Sulfate (Similar To Nda 19-516) SS Codeine SS Olanzapine SS Acetaminophen SS Paroxetine SS Bupropion SS Nicotine SS 24-Jun-2005 12:19 PM Page: 1766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/02ISR Number: 3872378-9Report Type:Periodic Company Report #2014811 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) PS Hydrocodone Bitartrate SS Hydroxyzine Hcl SS Pseudoephedrine Hcl SS Olanzapine SS Acetaminophen SS Phenylpropanolamine Hcl SS Chlorpheniramine Maleate SS Date:02/13/02ISR Number: 3872439-4Report Type:Periodic Company Report #2014461 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Oxycontin Cr Professional Tablets, 10 Mg Other (Oxycodone Hydrochloride) PS ORAL 10 MG BID PO Zyprexa (Olanzapine) SS Carbamazepine SS Clonazepam SS ORAL 2 MG TID PO Paroxetine Hcl C Date:02/13/02ISR Number: 3875530-1Report Type:Periodic Company Report #2013117 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Cr Professional Tablets, 10 Mg Other (Oxycodone Hydrochloride) PS ORAL PO Amitriptyline SS Olanzapine SS Trihexyphenidyl Hcl SS Alprazolam SS Cannabinoids SS Atropine SS Date:02/13/02ISR Number: 3876167-0Report Type:Periodic Company Report #2013013 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) PS Dihydrocodeine (Similar To Anda 88-584) SS Hydrocdone 24-Jun-2005 12:19 PM Page: 1767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bitartrate SS Ethanol (Alcohol, Anhydrous) SS Propoxyphene Hcl SS Butalbital Compound SS Temazepam SS Olanzapine SS Labetalol SS Acetaminophen SS Ibuprofen SS Salicylamide SS Caffeine Anhydride SS Nicotine SS Date:02/13/02ISR Number: 3876168-2Report Type:Periodic Company Report #2013014 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) PS MG Hydrocodone Bitartrate SS Dihydrocodeine (Similar To Anda 88-584) SS Fluoxetine SS MG Olanzapine SS MG Amphetamine SS MG Cocaine SS Acetaminophen SS MG Caffeine SS Nicotine SS Date:02/13/02ISR Number: 3876765-4Report Type:Periodic Company Report #2012099 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Cr Other Drug Dependence Professional Tablets, 20 Mg Company (Oxycodone Representative Hydrochloride) PS ORAL MG PO Olanzapine SS Date:02/13/02ISR Number: 3876767-8Report Type:Periodic Company Report #2012098 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Cr Other Drug Dependence Professional Tablets, 20 Mg Company (Oxycodone Representative Hydrochloride) PS ORAL MG PO Alprazolam SS ORAL MG PO Olanzapine SS Triazolam C 24-Jun-2005 12:19 PM Page: 1768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/02ISR Number: 3876805-2Report Type:Periodic Company Report #2012663 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride PS Other Hydrocodone Bitartrate SS Dihydrocodeine (Similar To Anda 88-584) SS Mirtazepine SS Temazepam SS Acetaminophen SS Carisoprodol SS Meprobamate SS Flurazepam SS Olanzapine SS Diazepam SS Salicylate SS Propoxyphene Hcl SS Caffeine Anhydride SS Date:02/13/02ISR Number: 3877729-7Report Type:Periodic Company Report #2013081 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) PS Xanax (Alprazolam) SS Zyprexa (Olanzapine) SS Zoloft (Sertraline Hcl) SS Cocaine SS Date:02/13/02ISR Number: 3880169-8Report Type:Periodic Company Report #2012651 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Cr Professional Tablets, 40 Mg Other (Oxycodone Hydrochloride) PS ORAL MG; PO Nicotine SS Acetaminophen SS Olanzapine SS Promethazine Hcl SS Meperidine Hcl SS Propoxyphene Hcl SS Clonazepam SS Xanax (Alprazolam) C Prozac (Fluoxetine) C Soma (Carisoprodol) C Neuronitn C 24-Jun-2005 12:19 PM Page: 1769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/02ISR Number: 3870831-5Report Type:Expedited (15-DaCompany Report #2002-BP-00018BP (0) Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Consumer Catapres Tts Dizziness Health (Clonidine Malaise Professional Hydrochloride) PS 0.1 MG (2.5 Sedation MG, 1 PATCH Q Syncope WEEK), TO Tinnitus Risperidone (Risperidone) SS ?2.5-5.0 MG QD, NR, DISCONTINUED 10/?/2001 AND RESTARTED Zyprexa SS ?2.5-5.0MG QD, NR Effexor C Date:02/15/02ISR Number: 3870851-0Report Type:Direct Company Report #CTU 161741 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Memory Impairment Zyprexa (Olonzapine) Eli Lilly PS Eli Lilly CA 6 MG ONCE A DAY Date:02/15/02ISR Number: 3871559-8Report Type:Expedited (15-DaCompany Report #2002092456FR Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Celebrex Initial or Prolonged Anxiety Health (Celecoxib)Capsule PS ORAL ORAL Cerebrovascular Accident Professional Imovane (Zopiclone) SS ORAL ORAL Confusional State Other Mopral (Omeprazole) SS ORAL ORAL Diarrhoea Deroxat(Paroxetine Hallucination Hydrochloride) SS ORAL ORAL Irritability Zyprexa(Olanzapine) SS ORAL 5 MG, QD, ORAL Tranxene(Clonazepate Dipotassium) SS ORAL 5 MG, QD, ORAL Corvasal C Sinemet C Date:02/19/02ISR Number: 3871477-5Report Type:Expedited (15-DaCompany Report #EWC020129784 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Olanzapine-Oral Life-Threatening Delirium Health (Olanzapine) PS 5 MG/DAY Fall Professional Stelazine Injury Other (Trifluoperazine Hydrochloride) C Cicladol (Piroxicam Betadex) C 24-Jun-2005 12:19 PM Page: 1770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/02ISR Number: 3871560-4Report Type:Expedited (15-DaCompany Report #02P-056-0187943-00 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Tranxene Initial or Prolonged Anxiety Other (Clorazepate Cerebrovascular Accident Dipotassium) Confusional State (Clorazepate Diarrhoea Dipotassium) PS ORAL 5 MG, 1 IN 1 Disorientation D, PER ORAL Drug Ineffective Zopiclone SS ORAL PER ORAL Hallucination Omeprazole SS ORAL PER ORAL Irritability Paroxetine Hydrochloride SS ORAL PER ORAL Olanzapine SS ORAL 5 MG, 1 IN 1 D, PER ORAL Celecoxib SS ORAL PER ORAL Molsidomine C Sinemet C Levomepromazine C Date:02/19/02ISR Number: 3871603-8Report Type:Expedited (15-DaCompany Report #USA020110677 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Zyprexa - Oral Initial or Prolonged Aggression (Olanzapine) Balance Disorder (Olanzapine) PS Coma Flovent (Fluticasone Dizziness Propionate) C Drug Level Increased Singulair Dyspnoea (Montelukast Sodium) C Epistaxis Albuterol C Fall Panmist Jr C Headache Mental Status Changes Miosis Somnolence Urinary Incontinence Date:02/19/02ISR Number: 3871604-XReport Type:Expedited (15-DaCompany Report #USA020110700 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa - Oral Platelet Count Increased Professional (Olanzapine) (Olanzapine) PS 3.75 MG / DAY Celexa (Citalopram Hydrobromide) C Date:02/19/02ISR Number: 3871820-7Report Type:Expedited (15-DaCompany Report #US_020181075 Age:25 YR Gender:Male I/FU:I Outcome PT Other Anxiety Bradykinesia Cogwheel Rigidity Condition Aggravated Decreased Activity 24-Jun-2005 12:19 PM Page: 1771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Drooling Gait Disturbance Report Source Product Role Manufacturer Route Dose Duration Kayser-Fleischer Ring Foreign Olanzapine PS ORAL 10 MG/DAY Masked Facies Literature Risperidone C Nervous System Disorder Health Biperiden C Nuclear Magnetic Professional Resonance Imaging Brain Other Abnormal Parkinsonism Posture Abnormal Psychotic Disorder Speech Disorder Tongue Paralysis Tremor Date:02/19/02ISR Number: 3871822-0Report Type:Expedited (15-DaCompany Report #CA_020104713 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa - Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 10 MG DAY Myositis Professional Clonazepam C Other Sertraline C Date:02/19/02ISR Number: 3871825-6Report Type:Expedited (15-DaCompany Report #CA_020104721 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) PS Professional Ace Inhibitor C Company Representative Other Date:02/19/02ISR Number: 3871826-8Report Type:Expedited (15-DaCompany Report #DE_020107868 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Zyprexa - Oral Initial or Prolonged Myocarditis Health (Olanzapine) PS 25 MG/DAY Prescribed Overdose Professional Haldol (Haloperidol) C Psychotic Disorder Other Diazepam C Pyrexia Neurocil (Levomepromazine Maleate) C Solian (Amisulpride) C Date:02/19/02ISR Number: 3871828-1Report Type:Expedited (15-DaCompany Report #DE_020107884 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Embolism Foreign Zyprexa-Oral Phlebitis Health (Olanzapine) PS 5MG/DAY Professional Tagonis Other (Paroxetine 24-Jun-2005 12:19 PM Page: 1772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Tafil (Alprazolam) C Date:02/19/02ISR Number: 3871830-XReport Type:Expedited (15-DaCompany Report #DE_020107885 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Foreign Zyprexa - Oral Health (Olanzapine) PS 2.5 MG/DAY Professional Remergil Other (Mirtazapine) C Trevilor (Venlafaxine Hydrochloride) C Date:02/19/02ISR Number: 3871831-1Report Type:Expedited (15-DaCompany Report #DE_020107904 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa -Oral First Degree Health (Olanzapine) PS 10 MG/DAY Bradycardia Professional Other Date:02/19/02ISR Number: 3871841-4Report Type:Expedited (15-DaCompany Report #FR_020100592 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Foreign Zyprexa Gastrointestinal Health (Olanzapine) PS 15 MG/DAY 5 MON Obstruction Professional Prozac SS 20 MG/DAY Other Depamide (Valpromide) C Artane (Trihexyphenidyl Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Date:02/19/02ISR Number: 3871843-8Report Type:Expedited (15-DaCompany Report #FR_020100599 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytolytic Hepatitis Foreign Zyprexa-Oral Health (Olanzapine) PS 10 MG/DAY Professional Anafranil Company (Clomipramine Representative Hydrochloride) C Other Date:02/19/02ISR Number: 3871844-XReport Type:Expedited (15-DaCompany Report #GBS020110061 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Myocardial Infarction Foreign Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 1773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/DAY Effexor (Venlafaxine Hydrochloride) C Date:02/19/02ISR Number: 3871846-3Report Type:Expedited (15-DaCompany Report #GBS020110076 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Zyprexa-Oral Sedation Health (Olanzapine) PS 15 MG Professional Sertraline C Other Date:02/19/02ISR Number: 3871847-5Report Type:Expedited (15-DaCompany Report #GBS020110077 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG/2 DAY Other Professional Mirtazapine C Other Date:02/19/02ISR Number: 3872037-2Report Type:Expedited (15-DaCompany Report #EWC020129788 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Olanzpine PS 10 MG/DAY Health Professional Other Date:02/19/02ISR Number: 3872039-6Report Type:Expedited (15-DaCompany Report #EWC020229858 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Peripheral Vascular Foreign Zyprexa- Oral Disorder Health (Olanzapine) PS 10 MG DAY Thrombocytopenia Professional Nefadar (Nefazodone Other Hydrochloride) C ORAL Vival ( Diazepam) C Flunipam (Flunitrazepam) C Date:02/19/02ISR Number: 3872469-2Report Type:Expedited (15-DaCompany Report #S02-FRA-00267-01 Age:41 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Asthenia Enanthema Eosinophilia 24-Jun-2005 12:19 PM Page: 1774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperpyrexia Liver Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Psychomotor Retardation Foreign Citalopram Rash Health (Citalopram Rash Maculo-Papular Professional Hydrobromide) PS ORAL 30 MG QD PO Other Tercian (Cyamemazine) SS Zyprexa (Olanzapine) SS ORAL 15 MG QD PO Heptamyl (Heptaminol Hydrochloride) SS ORAL 20 UNITS QD PO Stilnox (Zolpidem) SS ORAL 10 MG QD PO Parkinane (Trihexyphenidyl Hydrochloride) SS ORAL 5 MG QD PO Depamide (Valpromide) SS ORAL 300 MG TID PO Sulfarlem(Anethole Trihione) SS ORAL 150 MG QD PO Normacol SS Date:02/19/02ISR Number: 3872802-1Report Type:Expedited (15-DaCompany Report #US_020181147 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polymyositis Consumer Zyprexa-0ral (Olanzapine) (Olanzapine) PS 20 MG/DAY Date:02/19/02ISR Number: 3872831-8Report Type:Expedited (15-DaCompany Report #USA020110589 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apathy Consumer Zyprexa-Oral Other Difficulty In Walking (Olanzapine) Gastric Ulcer Haemorrhage (Olanzapine) PS 2.5 MG/2 DAY Listless Aricept (Donepezil Walking Disability Hydrochloride) C Weight Decreased Date:02/20/02ISR Number: 3872614-9Report Type:Direct Company Report #CTU 161898 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Zyprexa PS Lilly Pharm Co. ORAL 7.5 MG TABLET Intervention to PO QD Prevent Permanent Lipitor C Impairment/Damage Provera C Asa C Glyburide C Vit B C Vit E C Vit A+D C Tums C 24-Jun-2005 12:19 PM Page: 1775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3872827-6Report Type:Expedited (15-DaCompany Report #US_020281305 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Olanzapine-Oral Initial or Prolonged Chills Literature (Olanzapine) PS 5 MG/DAY 15 DAY Odynophagia Health Cyanamide(Calcium Purulent Discharge Professional Carbimide) C Pyrexia Other Tonsillar Ulcer Date:02/20/02ISR Number: 3872845-8Report Type:Expedited (15-DaCompany Report #GBS020210112 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Induced Foreign Olanzapine-Oral Maternal Drugs Affecting Literature (Olanzapine) PS Foetus Health Meningocele Professional Other Date:02/20/02ISR Number: 3872860-4Report Type:Expedited (15-DaCompany Report #US_020180581 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/ DAY Date:02/20/02ISR Number: 3873056-2Report Type:Expedited (15-DaCompany Report #US_020281275 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Health Prozac-Oral Initial or Prolonged Complications Of Maternal Professional (Fluoxetine)(Fluoxet Exposure To Therapeutic Other ine Hydrochloride) PS 80 MG/1 DAY Drugs Zyprexa-Oral Vomiting (Olanzapine)(Olanzap ine) SS 20 MG/1 DAY Celexa (Citalopram Hydrobromide) C Remeron (Mirtazapine) C Date:02/20/02ISR Number: 3873387-6Report Type:Expedited (15-DaCompany Report #USA020210909 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa-Oral Intentional Misuse Professional (Olanzapine) Company (Olanzapine0 PS 40 MG/DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/DAY 24-Jun-2005 12:19 PM Page: 1776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3873388-8Report Type:Expedited (15-DaCompany Report #USA011210215 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Propoxyphene Initial or Prolonged Blood Pressure Increased Professional Napsylate-With Depressed Level Of Acetaminophen PS Consciousness Zyprexa-Oral Glycosylated Haemoglobin (Olanzapine) Increased (Olanzapine) SS 15 MG/DAY Heart Rate Increased Neurontin Lethargy (Gabapentin) C Claritin (Loratadine) C Aricept(Donepezil Hydrochloride) C Trazodone C Remeron(Mitrazapine) C Transderm-Scop(Hyosc ine) C Date:02/20/02ISR Number: 3873391-8Report Type:Expedited (15-DaCompany Report #A0358791A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Communication Disorder Consumer Paxil (Paroxetine Initial or Prolonged Feeling Of Despair Hydrochloride) PS ORAL 20 MG/ORAL Loss Of Libido Paroxetine Suicidal Ideation Hydrochloride 60 Mg Suicide Attempt (Paroxetine Hydrochloride) SS ORAL ORAL Lithium Salt (Lithium Salt) SS Olanzapine (Olanzapine) SS Date:02/20/02ISR Number: 3873510-3Report Type:Expedited (15-DaCompany Report #USA020210987 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Zyprexa-Oral Initial or Prolonged Flat Affect Professional (Olanzapine) Company (Olanzapine) PS Representative Lithium C Date:02/20/02ISR Number: 3873523-1Report Type:Expedited (15-DaCompany Report #USA020110742 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Consumer Zyprexa-Oral Haemorrhage (Olanzapine) (Olanzapine) PS 5 MG/DAY 1 MON Synthroid (Levothyroxine Sodium) C Hydrocodone C Zoloft (Sertraline Hydrochloride) C Eskalith (Lithium 24-Jun-2005 12:19 PM Page: 1777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbonate) C Date:02/20/02ISR Number: 3873524-3Report Type:Expedited (15-DaCompany Report #US_020180309 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine Oral Initial or Prolonged Haematemesis Health (Olanzapine) PS Hallucination, Auditory Professional Clonopin Heart Rate Increased (Clonazepam) C Irritability Vasotec (Enalapril Psychomotor Hyperactivity Maleate) C Psychotic Disorder Tylenol (Paracetamol) C Date:02/20/02ISR Number: 3873710-2Report Type:Expedited (15-DaCompany Report #USA020210937 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:02/20/02ISR Number: 3873711-4Report Type:Expedited (15-DaCompany Report #USA020210935 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Arrhythmia Health Zyprexa -Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:02/20/02ISR Number: 3873756-4Report Type:Expedited (15-DaCompany Report #DE_020107832 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral Neutrophil Count Health (Olanzapine) Decreased Professional (Olanzapine) PS 20 MG/DAY Other Remergil (Mirtazapine) C Tavor (Lorazepam) C Date:02/20/02ISR Number: 3873803-XReport Type:Expedited (15-DaCompany Report #US_020281427 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Zyprexa-Oral Depressed Level Of Study (Olanzapine) Consciousness Health (Olanzapine) PS 20 MG/DAY Injury Asphyxiation Professional Lodopin (Zotepine) C Urinary Incontinence Other Tolopelon (Timiperone) C Serenace (Haloperidol) C Akineton (Biperiden 24-Jun-2005 12:19 PM Page: 1778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Eurodin (Estazolam) C Vegetamin A C Silece (Flunitrazepam) C Date:02/20/02ISR Number: 3873804-1Report Type:Expedited (15-DaCompany Report #US_020281417 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akathisia Foreign Olanzapine-Oral Cerebral Infarction Study (Olanzapine) PS 10 MG/2 DAY Condition Aggravated Health Mellaril Dysarthria Professional (Thioridazine Extrapyramidal Disorder Other Hydrochloride) C Gastroduodenal Ulcer Dogmatyl Hemiparesis (Sulpidride) C Irritability Tolopelon Salivary Hypersecretion (Timiperone) C Schizophrenia, Paranoid Sepazon (Cloxazolam) C Type Parlodel Thirst (Bromocriptine Thrombotic Stroke Mesilate) C Tremor Cystanin (L-Cysteine Ethyl Ester, Hydrochloride) C Mucosta (Rebamipide) C Silece (Flunitrazepam) C Tasmolin (Biperiden) C Date:02/20/02ISR Number: 3873805-3Report Type:Expedited (15-DaCompany Report #AU_010102981 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa-Oral Coronary Artery Health (Olanzapine) Atherosclerosis Professional (Olanzapine) PS 20 MG/DAY Coronary Artery Occlusion Other Fluphenazine Hypertension Decanoate C Kidney Small Fluanzol - Slow Myocardial Ischaemia Release (Flupentixol Pulmonary Congestion Decanoate) C Pulmonary Oedema Flupentixol C Weight Increased Date:02/20/02ISR Number: 3873806-5Report Type:Expedited (15-DaCompany Report #GBS020210143 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Foreign Zypreza-Oral Muscle Contractions Health (Olanzapine) Involuntary Professional (Olanzapine) PS 10 MG/ 2 DAY Tongue Disorder Other Diclofenac C Nivea Cream C 24-Jun-2005 12:19 PM Page: 1779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3873962-9Report Type:Expedited (15-DaCompany Report #GBS020210110 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Axillary Vein Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Blood Creatinine Literature (Olanzapine) PS Other Increased Health Blood Pressure Increased Professional Crying Other Depressed Level Of Consciousness Disorientation Euphoric Mood Hyperhidrosis Hypomania Insomnia Irritability Mental Impairment Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:02/20/02ISR Number: 3873980-0Report Type:Expedited (15-DaCompany Report #US_010872415 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Hospitalization - C-Reactive Protein Health Serenace Initial or Prolonged Increased Professional (Haloperidol) C Chromosome Abnormality Company Contomin Fatigue Representative (Chlorpromazine Granulocytopenia Other Hydrochloride) C Headache Rohypnol Mucosal Erosion (Flunitrazepam) C Myelodysplastic Syndrome Levotomin Oral Infection (Levomepromazine Platelet Count Increased Maleate) C Pyrexia Benzalin Red Blood Cell Count (Nitrazepam) C Decreased Schizophrenia Staphylococcal Infection Tongue Discolouration Vomiting Date:02/20/02ISR Number: 3873992-7Report Type:Expedited (15-DaCompany Report #EWC010727733 Age:35 YR Gender:Male I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Autoimmune Hepatitis Disability Diabetes Mellitus Inadequate Control Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Fatigue Haematuria Hepatic Steatosis 24-Jun-2005 12:19 PM Page: 1780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatitis Hyperventilation Microalbuminuria Report Source Product Role Manufacturer Route Dose Duration Nausea Foreign Olanzapine PS 15 MG/DAY Renal Impairment Health Deroxat (Paroxetine Renal Tubular Disorder Professional Hydrochloride) C Thrombocythaemia Company Vomiting Representative Weight Increased Other Date:02/20/02ISR Number: 3874001-6Report Type:Expedited (15-DaCompany Report #US_011178209 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Foreign Zyprexa-Oral Hospitalization - Decreased Health (Olanzapine) Initial or Prolonged Cardio-Respiratory Arrest Professional (Olanzapine) PS 15 MG/DAY Other Condition Aggravated Company Timiperone C Diabetes Mellitus Representative Biperiden C Diabetic Coma Other Sepazon (Cloxazolam) C Diabetic Hyperosmolar Lipantil Coma (Fenofibrate) C Encephalopathy Seroquel C Hepatotoxicity Serenace Hyperlipidaemia (Haloperidol) C Increased Appetite Impromen Parkinsonism (Bromperidol) C Date:02/20/02ISR Number: 3874008-9Report Type:Expedited (15-DaCompany Report #US_020180609 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alkalosis Foreign Zyprexa-Oral Other Blood Pressure Decreased Health (Olanzapine) Cholangitis Professional (Olanzapine) PS 2.5 MG/DAY Cholelithiasis Company Rohypnol Condition Aggravated Representative (Flunitrazepam) C Hepatic Atrophy Other Hepatocellular Damage Hypernatraemia Pallor Pulse Absent Urinary Incontinence Date:02/20/02ISR Number: 3874009-0Report Type:Expedited (15-DaCompany Report #US_020180702 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Blood Potassium Increased Professional (Olanzapine) PS ORAL 5 MG/DAY Blood Urea Increased Company Serenace Condition Aggravated Representative (Haloperidol) C Psychiatric Symptom Other Lendormin (Brotizolam) C Cercin (Diazepam) C Eutensin (Furosemide) C 24-Jun-2005 12:19 PM Page: 1781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Predonine (Prednisolone) C Lasix (Furosemide) C Sodium Bicarbonate C Aspara-Ca (Aspartate Calcium) C Selbex (Teprenone) C Alesion (Epinastine Hydrochloride) C Physio 35 C Vitamedin Intravenous C Flavine Adenine Dinucleotide C Solita T C Date:02/20/02ISR Number: 3874010-7Report Type:Expedited (15-DaCompany Report #US_020180048 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Olanzapine-Oral Other Cerebral Infarction Study (Olanzapine) PS 10 MG DAY Gastric Cancer Health Isosorbide Dinitrate C White Blood Cell Count Professional Eurodin (Estrazolam) C Increased Other Hiberna (Promethazine Hydrochloride) C Lendormin (Brotizolam) C Ganaton (Fm) (Ganaton (Fm)) C Laxoberon (Sodium Picosulfate) C Senna Liquid Extract C Impromen (Bromperidol) C Calslot (Manidipine Hydrochloride) C Cetapril (Alacepril) C Panaldine (Ticlopidine Hydrochloride) C Date:02/20/02ISR Number: 3874023-5Report Type:Expedited (15-DaCompany Report #US_020180775 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Olanzapine-Oral Constipation Study (Olanzapine) PS 10 MG DAY Headache Health Pursennid (Senna Professional Leaf) C Other Ferrous Sulfate C 24-Jun-2005 12:19 PM Page: 1782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3874027-2Report Type:Expedited (15-DaCompany Report #EWC020129740 Age:3 MON Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Foreign Zyprexa-Oral Initial or Prolonged Maternal Drugs Affecting Health (Olanzapine) Congenital Anomaly Foetus Professional (Olanzapine) PS Spina Bifida Company Frontin (Alprazolam) C Representative Tegretol Other (Carbamazepine) C Date:02/20/02ISR Number: 3874029-6Report Type:Expedited (15-DaCompany Report #EWC010928195 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Blood Creatine Health Lexomil (Bromazepam) C Phosphokinase Increased Professional Temesta (Lorazepam) C Blood Lactate Other Tercian Dehydrogenase Increased (Cyamemazine) C Hypokalaemia Parkinane Polyuria (Trihexyphenidyl Hydrochloride) C Date:02/21/02ISR Number: 3872712-XReport Type:Direct Company Report #CTU 161967 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa PS Hospitalization - Non-Insulin-Dependent Lithium C Initial or Prolonged Diabetic Coma Depakote C Required Diabetic Ketoacidosis Serzone C Intervention to Prevent Permanent Impairment/Damage Date:02/21/02ISR Number: 3872749-0Report Type:Direct Company Report #CTU 162019 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Olanzapine PS ORAL 5MG QD PO Initial or Prolonged Phosphokinase Increased Depakote C Other Hyperhidrosis Paroxetine C Hyperpyrexia Lansoprazole C Hypertension Sinemet Cr C Hypoxia Phenytoin C Incontinence Bisacodyl C Mental Status Changes Colace C Neuroleptic Malignant Senokot C Syndrome Diazepam C Respiratory Rate Lorazepam C Increased Tachycardia Tachypnoea 24-Jun-2005 12:19 PM Page: 1783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/02ISR Number: 3872754-4Report Type:Direct Company Report #CTU 162025 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tongue Oedema Zyprexa 20mg Lilly PS Lilly Initial or Prolonged Metoclopramide 10mg Generic Par Pharma SS Par Pharma 10MG BID Insulin R C Insulin N C Atrovent C Vasotec C Cardura C Date:02/21/02ISR Number: 3873521-8Report Type:Expedited (15-DaCompany Report #US_011177261 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Zyprexa-Oral Initial or Prolonged Blood Creatinine Abnormal Professional (Olanzapine) Blood Glucose Abnormal Company (Olanzapine) PS 5 MG/1 DAY Blood Urea Abnormal Representative Prozac-Oral Dehydration (Fluoxetine) Diabetes Mellitus (Fluoxetine Inadequate Control Hydrochloride SS 20 MG/DAY Diverticulum Flovent (Fluticasone Dyspnoea Exacerbated Propionate) C Hypertension Lasix (Furosemide) C Myositis Prilosec Respiratory Failure (Omeprazole) C Skin Ulcer Avandia Urinary Tract Infection (Rosiglitazone Maleate) C Date:02/22/02ISR Number: 3875240-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001013 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Reminyl Initial or Prolonged Dyskinesia Health (Galantamine) PS ORAL 24 MG, DAY Dystonia Professional (S), ORAL Gait Disturbance Dipiperon (40 Mg Movement Disorder Tablet) Muscle Disorder (Pipamperone) SS ORAL 160 MG, DAY Muscle Tightness (S), ORAL Myogelosis Risperdal (Risperidone) SS ORAL 1 MG, DAY (S), ORAL Zyprexa (Olanzapine) SS ORAL 2.5 MG, DAY (S), ORAL Akatinol Mematine (Memantine) C Presomen (Estrogens Conjugated) C 24-Jun-2005 12:19 PM Page: 1784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/02ISR Number: 3873319-0Report Type:Direct Company Report #CTU 162151 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Zyrexa 5mg (Lilly) PS Lilly ORAL 5MG PO DAILY Date:02/25/02ISR Number: 3874223-4Report Type:Expedited (15-DaCompany Report #EWC020229908 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Foreign Zyprexa-Oral(Olanzap Initial or Prolonged Thrombocytopenic Purpura Health ine) (Olanzapine) PS 5 M/DAY Petechiae Professional Company Representative Other Date:02/25/02ISR Number: 3874225-8Report Type:Expedited (15-DaCompany Report #FR_020100538 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zyprexa-Oral Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS 10 MG/DAY Maternal Drugs Affecting Other Norset (Mirtazapine0 C Foetus Tegretol(Carbamazepi ne) C Date:02/25/02ISR Number: 3874959-5Report Type:Direct Company Report #CTU 162275 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Zyprexa PS Consciousness Zyrtec SS Fatigue Lethargy Medication Error Date:02/27/02ISR Number: 3876065-2Report Type:Expedited (15-DaCompany Report #02P-062-0188088-00 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Akineton Ampules Initial or Prolonged Health (Akineton) Professional (Biperiden) (Biperiden) PS INTRAVENOUS 2.5 MG, 1 IN 1 D, INTRAVENOUS ; Akineton (Biperiden) (Biperiden) SS ORAL 4 MG, 2 IN 1 D, PER ORAL ; 2 MG, 2 IN 1 D, PER ORAL Clatyl-Z Acuphase SS INTRAMUSCULAR SEE IMAGE Olanzapine SS ORAL 10 MG, 1 IN 1 D , PER ORAL Perazine SS ORAL 100 MG, 1 IN 1 D, PER ORAL 24-Jun-2005 12:19 PM Page: 1785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diazepam C Fluanxol C Date:02/27/02ISR Number: 3882018-0Report Type:Periodic Company Report #US_010464338 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Weight Increased Professional Prozac (Fluoxetine Hydrochloride) SS Restoril (Temazepam) C Tergretol (Cambamazepine) C Neurontin (Gabapentin) C Date:02/27/02ISR Number: 3882019-2Report Type:Periodic Company Report #US_010463673 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG DAY Lorazepam C Lipitor (Atorvastatin) C Naprosyn (Naprosyn) C Imitrex (Sumatriptan Succinate) C Date:02/27/02ISR Number: 3882021-0Report Type:Periodic Company Report #US_010463717 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Olanzapine PS 6 MG DAY Initial or Prolonged Hyperglycaemia Health Fluoxetine Vertigo Positional Professional (Fluoxetine Vision Blurred Hydrochloride) SS ORAL 25 MG DAY Aspirin C Acetaminophen C Ibuprofen C Hydrochlorothiazide C Rhinocort (Budesonide) C Midrin C Date:02/27/02ISR Number: 3882026-XReport Type:Periodic Company Report #US_010362401 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Olanzapine PS 12 MG/1 IN Initial or Prolonged Diabetic Ulcer Health THE EVENING Disability Osteomyelitis Acute Professional Fluoxetine Pneumonia (Fluoxetine Hydrochloride) SS 25 MG/1 IN THE EVENING 24-Jun-2005 12:19 PM Page: 1786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin Humulin 70/30 C Glucophage (Metformin Hydrochloride) C Accupril (Quinapril Hydrochloride) C Lasix (Furosemide) C Klor-Con (Potassium Chloride) C Folic Acid C Erythromycin C Naproxen C Ativan (Lorazepam) C Amaryl (Glimepiride) C Humulin R (Insulin Human) C Vitamin C C Mevacor (Lovastatin) C Feosol (Ferrus Sulfate) C Lotensin (Benazepril Hydrochloride) C Date:02/27/02ISR Number: 3882028-3Report Type:Periodic Company Report #US_010361875 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Completed Suicide Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 60 MG DAY Lorazepam C Date:02/27/02ISR Number: 3882041-6Report Type:Periodic Company Report #US_010565199 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laceration Study Olanzapine PS 6 MG DAY Initial or Prolonged Multiple Fractures Health Fluoxetine Road Traffic Accident Professional (Fluoxetine Hydrochloride SS 25 MG DAY Flovent (Fluticasone Propionate) C Albuterol C Premarin (Estrogens Conjugated) C Serevent (Salmeterol Xinfoate) C Date:02/27/02ISR Number: 3882046-5Report Type:Periodic Company Report #US_010565172 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Post-Traumatic Stress Study Olanzapine PS 1 DSG Initial or Prolonged Disorder Health FORM/DAY Professional Fluoxetine (Fluoxetine 24-Jun-2005 12:19 PM Page: 1787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS 1 DSG FORM/DAY Restoril (Temazepam) C Date:02/27/02ISR Number: 3882048-9Report Type:Periodic Company Report #US_010565000 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Literature Olanzapine PS 10 MG/1 DAY Initial or Prolonged Diabetes Mellitus Health Fluoxetine Other Sexual Dysfunction Professional Hydrochloride SS Suicidal Ideation Mirtazapine C Suicide Attempt Benztropine C Weight Decreased Temazepam C Weight Increased Date:02/27/02ISR Number: 3890541-8Report Type:Periodic Company Report #US_010872766 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adjustment Disorder Study Olanzapine PS Initial or Prolonged Mania Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Olanzapine SS 5 MG/DAY Lorazepam C Albuterol C Vicodin C Date:02/27/02ISR Number: 3890542-XReport Type:Periodic Company Report #US_010872773 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Professional Prozac (Fluoxetine Hydrochloride) SS 60 MG/1 DAY Celexa (Citalopram Hydrobromide) C Remeron (Mirtazapine) C Multivitamins Nos (Multivitamins Nos) C Folate Sodium C Iron Sulfate C Date:02/27/02ISR Number: 3890543-1Report Type:Periodic Company Report #US_010872780 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Study Olanzapine PS 18 MG IN THE Initial or Prolonged Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG IN THE EVENING Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/02ISR Number: 3890544-3Report Type:Periodic Company Report #US_010871889 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Acute Stress Disorder Prozac (Fluoxetine Other Aggression Hydrochloride) SS Anxiety Depression Fear Intentional Self-Injury Liver Function Test Abnormal Visual Disturbance Weight Increased Date:02/27/02ISR Number: 3890547-9Report Type:Periodic Company Report #US_010871269 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Study Olanzapine PS 6 MG DAY Initial or Prolonged Interstitial Lung Disease Health Fluoxetine Pneumonitis Professional (Fluoxetine Hydrochloride) SS 25 MG DAY Atenolol C Lipitor (Atorvastatin) C Prempro C Zyrtec (Cetirizine Hydrochlorde) C Flonase (Fluticasone Propionate) C Soma (Carisoprodol) C Date:02/27/02ISR Number: 3890548-0Report Type:Periodic Company Report #US_010870770 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG IN THE Initial or Prolonged Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloriede) SS 25 MG IN THE EVENING Estrogen Nos C Pravachol (Pravastatin Sodium) C Synthroid (Levothyroxine Sodium) C Date:02/27/02ISR Number: 3890549-2Report Type:Periodic Company Report #US_010870697 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Prozac (Fluoxetine Initial or Prolonged Dysgeusia Hydrochloride) PS 40 MG/DAY Fall Zyprexa (Olanzapine) SS 1 MON Darvocet- N-. 24-Jun-2005 12:19 PM Page: 1789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Propoxypnene Napsylate) SS 1 MON Effexor (Venlafaxine Hydrochloride) C Librium C Xanax (Alprazolam) C Synthroid (Levothyroxine Sodium) C Duradrin C Date:02/27/02ISR Number: 3890553-4Report Type:Periodic Company Report #US_010769959 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Impaired Healing Study Olanzapine PS 6MG/1 IN THE Initial or Prolonged Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG /1 IN THE EVENING Hydrochlorothiazide C Date:02/27/02ISR Number: 3890554-6Report Type:Periodic Company Report #US_010769887 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12MG IN THE Initial or Prolonged Suicidal Ideation Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG IN THE EVENING Ativan(Lorazepam) C Ramipril C Pempro C Date:02/27/02ISR Number: 3890555-8Report Type:Periodic Company Report #US_010769900 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 6 MG DAY Initial or Prolonged Depression Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG DAY Lorazepam C Date:02/27/02ISR Number: 3890558-3Report Type:Periodic Company Report #US_010769079 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 5 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG/AT BEDTIME Vitamin E C 24-Jun-2005 12:19 PM Page: 1790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin C C Aspirin C Tums C Estrace(Estradiol) C Date:02/27/02ISR Number: 3890559-5Report Type:Periodic Company Report #US_010768865 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Study Olanzapine PS 20 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 80 MG/IN THE MORNING Date:02/27/02ISR Number: 3890560-1Report Type:Periodic Company Report #US_010768905 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Olanzapine PS 12 MG DAY Initial or Prolonged Congestive Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 75 MG DAY Multivitamin C Vasotec (Enalapril Maleate) C Glucophage (Metformin Hydrochloride) C Glyburide C Prilosec(Omeprazole) C Actos (Pioglitazone) C Lasix (Furosemide0 C Spironolactone C Zocor(Simvastatin) C Precose(Acarbose) C Premarin(Estrogens Conjugated) C Hyoscyamine C Glucovance C Motrin(Ibuprofen) C Prevacid (Lansoprazole) C Date:02/27/02ISR Number: 3890563-7Report Type:Periodic Company Report #US_010768695 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 1 DSG FORM/AT Initial or Prolonged Dyspnoea Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 1 DSG FORM/AT BEDTIME Prinzide C Atenolol C Asa (Acetilsalicylic 24-Jun-2005 12:19 PM Page: 1791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid) C Multivitamin C Niacin C Excedrin Migraine C Date:02/27/02ISR Number: 3890571-6Report Type:Periodic Company Report #US_010667555 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 6 MG DAY Initial or Prolonged Suicide Attempt Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 75 MG DAY Lorazepam C Date:02/27/02ISR Number: 3890573-XReport Type:Periodic Company Report #US_010566786 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 75 MG DAY Ativan (Lorazepam) C Date:02/27/02ISR Number: 3890574-1Report Type:Periodic Company Report #US_010566513 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 12 MG DAY Initial or Prolonged Dyspnoea Health Fluoxetine Oedema Peripheral Professional (Fluoxetine Hydrochloride) SS 25 MG DAY Rolaids (Dihydroxyaluminum Sodium Carbonate) C Metamucil (Psyllium Hydrophilic Mucilloid) C Prevacid (Lansoprazole) C Voltaren (Diclofenac Sodium) C Ibuprofen C Tums C Alka-Seltzer C Date:02/27/02ISR Number: 3890575-3Report Type:Periodic Company Report #US_010566387 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 1 DSG FORM/ Initial or Prolonged Health AT BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 1 DSG FORM/ AT BEDTIME Synthroid 24-Jun-2005 12:19 PM Page: 1792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine Sodium) C Premarin (Estrogens Conjugated) C Albuterol C Propantheline C Date:02/27/02ISR Number: 3890596-0Report Type:Periodic Company Report #US_000541050 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Major Depression Study Olanzapine PS 25 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine Hydrochloride SS 60 MG/1 IN THE MORNING Prevacid (Lansoprazole) C Loestrin C Naprosyn (Naproxen) C Tylenol (Paracetamol) C Date:02/27/02ISR Number: 3890598-4Report Type:Periodic Company Report #US_001255724 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sinusitis Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Protonix C Avandia (Rosiglitazone Maleate) C Kcl-Retard (Potassium Chloride) C Lasix (Furosemide) C Singulair (Montelukast Sodium) C Date:02/27/02ISR Number: 3890599-6Report Type:Periodic Company Report #US_001050921 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine PS 6 MG/1 DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG/1 DAY Chloral Hydrate C Date:02/27/02ISR Number: 3890601-1Report Type:Periodic Company Report #US_001052128 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Olanzapine PS 12 MG/1 AT Initial or Prolonged Depressed Mood Health BEDTIME Professional Fluoxetine 24-Jun-2005 12:19 PM Page: 1793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride SS 25 MG/1 AT BEDTIME Serax (Oxazepam) C Multivitamin C Ativan (Lorazepam) C Date:02/27/02ISR Number: 3890602-3Report Type:Periodic Company Report #US_001052448 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Study Nortriptyline Initial or Prolonged Health (Nortriptyline Professional Hydrochloride) PS 100 MG Olanzapine SS 12 MG/1 DAY Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG/1 DAY Nitro Patch (Glyceryl Trinitrate) C Zocor (Simvastatin) C Zocor (Simvastatin) C Folic Acid C Date:02/27/02ISR Number: 3890603-5Report Type:Periodic Company Report #US_000643670 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 12 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 AT BEDTIME Valium (Diazepam) C Date:02/27/02ISR Number: 3890615-1Report Type:Periodic Company Report #US_000745588 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Study Olanzapine PS 6 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG AT BEDTIME Aspirin C Bactrim C Date:02/27/02ISR Number: 3890616-3Report Type:Periodic Company Report #US_000746066 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Olanzapine PS 6 MG/1 DAY Initial or Prolonged Suicide Attempt Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG/1 DAY 24-Jun-2005 12:19 PM Page: 1794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/02ISR Number: 3890617-5Report Type:Periodic Company Report #US_000846584 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Study Fluoxetine Hospitalization - Suicide Attempt Health (Fluoxetine Initial or Prolonged Professional Hydrochloride) PS 50 MG/1 IN THE EVENING Olanzapine SS 6 MG/1 THE EVENING Date:02/27/02ISR Number: 3890618-7Report Type:Periodic Company Report #US_000846912 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Study Olanzapine PS 12 MG/1 DAY Initial or Prolonged Breast Cancer Health Fluoxetine Other Dehydration Professional (Fluoxetine Vomiting Hydrochloride) SS 25 MG/1 DAY Folic Acid C Vitamin B-6 C Vitamin B12 C Selenium C Betacarotene C Aspirin C Prempro C Soy C Calcium C Magnesium C Zinc C Calcium And Vitamin D C Iron C Vitamin E C Neurontin (Gabapentin) C Date:02/27/02ISR Number: 3890630-8Report Type:Periodic Company Report #US_000848421 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 6 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG/1 AT BEDTIME Ativan (Lorazepam) C Date:02/27/02ISR Number: 3890633-3Report Type:Periodic Company Report #US_000950743 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/02ISR Number: 3890643-6Report Type:Periodic Company Report #US_010158314 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Prozac (Fluoxetine Initial or Prolonged Professional Hydrochloride) PS Zyprexa (Olanzapine) SS Lamictal(Lamotrigine ) C Date:02/27/02ISR Number: 3890647-3Report Type:Periodic Company Report #US_010260203 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 6 MG AT Initial or Prolonged Pneumonia Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG AT BEDTIME Caltrate (Calcium Carbonate) C Advil (Ibuprofen) C Lorazepam C Levoxacin (Levofloxacin) C Trazodil (Trazodone Hydrochloride) C Date:02/27/02ISR Number: 3890649-7Report Type:Periodic Company Report #US_010260220 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG DAY Initial or Prolonged Paranoia Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG DAY Lorazepam C Date:02/27/02ISR Number: 3890652-7Report Type:Periodic Company Report #US_010260051 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Prozac (Fluoxetine Initial or Prolonged Professional Hydrochloride) PS 10 MG/2 DAY Company Zyprexa (Olanzapine) SS 2.5 MG/ IN Representative THE EVENING Date:02/27/02ISR Number: 3890655-2Report Type:Periodic Company Report #US_010259312 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Olanzapine PS 12 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/AT BEDTIME 24-Jun-2005 12:19 PM Page: 1796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix (Furosemide) C Vioxx (Rofecoxib) C Carpal Tunnel Syndrome C Diovan (Valsartan) C Date:02/27/02ISR Number: 3890662-XReport Type:Periodic Company Report #US_010158989 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG/AT Initial or Prolonged Hallucination, Auditory Health BEDTIME Suicidal Ideation Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG/AT BEDTIME Date:02/27/02ISR Number: 3891218-5Report Type:Periodic Company Report #US_010157728 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subarachnoid Haemorrhage Study Olanzapine PS 6 MG/1 IN THE Initial or Prolonged Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG/1 IN THE EVENING Ziac C Progesterone C Premarin (Estrogens Conjugated) C Flovent (Fluticasone Propionate) C Alupent (Orciprenaline Sulfate) C Ativan (Lorazepam) C Date:02/27/02ISR Number: 3891220-3Report Type:Periodic Company Report #US_010157590 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Murder Study Olanzapine PS 6 MG/1 IN THE Health EVENING Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG/1 IN THE MORNING Synthroid (Levothyroxine Sodium) C Actos (Pioglitazone) C Humulin 70/30 C Ibuprofen C 24-Jun-2005 12:19 PM Page: 1797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/02ISR Number: 3891222-7Report Type:Periodic Company Report #US_010157612 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Olanzapine PS 6 MG 1/DAY Initial or Prolonged Inadequate Control Health Fluoxetine Hyperglycaemia Professional (Fluoxetine Ketoacidosis Hydrochloride) SS 25 MG/1 DAY Covera (Verapamil Hydrochloride) C Accupril (Quinapril Hydrochloride) C Synthroid (Levothyroxine Sodium) C Furosemide C Multivitamin C Univasc (Moexipril Hydrochloride) C Date:02/27/02ISR Number: 3891224-0Report Type:Periodic Company Report #US_010157452 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG/AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG/AT BEDTIME Lorazepam C Date:02/27/02ISR Number: 3891234-3Report Type:Periodic Company Report #US_010158788 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Study Olanzapine PS 12 MG/DAY Initial or Prolonged Suicidal Ideation Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG/DAY Olanzapine C Tylenol (Paracetamol) C Ativan (Lorazepam) C Date:02/27/02ISR Number: 3891236-7Report Type:Periodic Company Report #US_010158644 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Consumer Prozac (Fluoxetine Initial or Prolonged Feeling Hot Hydrochloride) PS Headache Zyprexa (Olanapine) SS 2.5 MG/DAY 6 WK Paraesthesia Valproic Acid C Somnolence Haldol (Haloperidol) C Suicidal Ideation 24-Jun-2005 12:19 PM Page: 1798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/02ISR Number: 3891488-3Report Type:Periodic Company Report #US_990927684 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Fluoxetine Initial or Prolonged Health (Fluoxetine Professional Hydrochloride) PS 20 MG/1 DAY Olanzapine SS 10 MG/1 DAY Glucophage (Metformin Hydrochloride) C Glucotrol (Glipizide) C Cardizem Cd (Diltiazem Hydrochloride) C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Date:02/27/02ISR Number: 3891490-1Report Type:Periodic Company Report #US_980504135 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Study Olanzapine PS 10 MG/DAY Initial or Prolonged Health Prozac (Fluoxetine Professional Hydrochloride) SS 20 MG/DAY Depakote (Valproate Semisodium) C Sudafed (Pseudoephedrine Hydrochloride) C Bc Powder C Genora C Vicks Formula 44 C Testosterone Propionate C Prozac (Fluoxetine Hydrochloride) C Multivitamin C Date:02/27/02ISR Number: 3891491-3Report Type:Periodic Company Report #US_011278680 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Study Olanzapine-Oral Initial or Prolonged Pulmonary Disease Health (Olanzapine) PS 12 MG DAY Professional Fluoxetine-Oral (Fluoxetine) (Fluoxeitine Hydrochlor SS 75 MG DAY Celebrex (Celecoxib) C Centrum Silver C Zinc C Premarin (Estrogens Conjugated) C Vitamin C C Quinine C Toprol Xl (Metoprolol 24-Jun-2005 12:19 PM Page: 1799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Succinate) C Aspirin C Hydrodiuril (Hydrochlorothiazide ) C Date:02/27/02ISR Number: 3891493-7Report Type:Periodic Company Report #US_011177909 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 6 MG DAY Professional Fluoxetine-Oral (Fluoxetine) (Fluoxeitine Hydrochlor SS 25 MG DAY Date:02/27/02ISR Number: 3891495-0Report Type:Periodic Company Report #US_011076168 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Non-Small Cell Lung Study Olanzapine PS 6 MG DAY Initial or Prolonged Cancer Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG DAY Combivent C Albuterol C Date:02/27/02ISR Number: 3891496-2Report Type:Periodic Company Report #US_011075901 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Placebo PS Initial or Prolonged Health Placebo SS Professional Olanzapine SS Fluoxetine (Fluoxetine Hydrochloride) SS 25 MG/DAY Valium (Diazepam) C Allegra-D C Aleve(Naproxen Sodium) C Zithromax (Azithromycin) C Soma (Carisoprodol) C Date:02/27/02ISR Number: 3891497-4Report Type:Periodic Company Report #US_010158917 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Study Olanzapine PS 6 MG/1 AT Initial or Prolonged Health BEDTIME Professional Fluoxetine Hydrochloride SS 75 MG/1 AT BEDTIME Multivitamin C Ventolin(Salbutamol) C Pulmicort 24-Jun-2005 12:19 PM Page: 1800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Budesonide) C Prevacid (Lansoprazole) C Serax (Oxazepam) C Celebrex (Celecoxib) C Indapamide C Zyrtec (Cetirizine Hydrochloride) C Midrin C Date:02/27/02ISR Number: 3891498-6Report Type:Periodic Company Report #US_010361877 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Ativan (Lorazepam) C Date:02/27/02ISR Number: 3891499-8Report Type:Periodic Company Report #US_010361468 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Olanzapine PS 12 MG/1 DAY Initial or Prolonged Suicidal Ideation Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 75 MG /1 DAY Centrum C Selenium C Vitamin E C Vitamin C C Date:02/27/02ISR Number: 3891501-3Report Type:Periodic Company Report #US_010361198 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Olanzapine PS 1 DSG Initial or Prolonged Health FORM/DAY Professional Fluoxetine (Fluoxetie Hydrochloride) SS 1 DSG FORM/DAY Date:02/27/02ISR Number: 3891502-5Report Type:Periodic Company Report #US_010361109 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Study Olanzapine PS 12 MG DAY Initial or Prolonged Dyspnoea Exertional Health Fluoxetine Electrocardiogram T Wave Professional (Flouxetine Inversion Hydrochloride) SS 25 MG DAY Celebrex (Celecoxib) C Imitrex (Sumatriptan Succinate) C Fioricet C Estrace (Estradiol) C Tylenol 24-Jun-2005 12:19 PM Page: 1801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paracetamol) C Aspirin C Date:02/27/02ISR Number: 3891504-9Report Type:Periodic Company Report #US_010260691 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Study Olanzapine PS Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS Mircette C Multivitamin C Prempro C Asa (Acetylsalicylic Acid) C Zantac (Ranitidine Hydrochloride) C Date:02/27/02ISR Number: 3891506-2Report Type:Periodic Company Report #US_010362974 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Olanzapine PS 6 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 50 MG AT BEDTIME Valium (Diazepam) C Celebrex (Celecoxib) C Date:02/28/02ISR Number: 3878169-7Report Type:Expedited (15-DaCompany Report #2002-02-1107 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Health Rebetol (Ribavirin) Amniocentesis Abnormal Professional Capsules PS ORAL 1200 MG QD Foetal Disorder Company ORAL Pregnancy Representative Intron A (Interferon Transmission Of Drug Via Alfa-2b Recombinant) Semen Injectable Solution SS SUBCUTANEOUS 3 MU TIW Ultrasound Scan Abnormal SUBCUTANEOUS Gabapentin SS Olanzapine SS Date:03/01/02ISR Number: 3876661-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE00808 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Ludiomil Initial or Prolonged Study (Maprotiline Health Hydrochloride) Professional Film-Coated Tablet PS ORAL 50 MG/DAY, Other ORAL Ludiomil (Maprotiline Hydrochloride) 24-Jun-2005 12:19 PM Page: 1802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Solution For Injection SS INTRAVENOUS 50 - 150 MG/DAY, INTRAVENOUS Zyprexa (Olanzapine) Film-Coated Tablet SS ORAL 2.5 MG/DAY, ORAL Ergenyl "Sanofi" (Valproate Sodium) Enteric-Film-Coated Tablet SS Sanofi ORAL SEE IMAGE Alna (Tamsulosin Hydrochloride) Slow Release Tablet SS ORAL 0.4 MG/DAY, ORAL Staurodorm Neu (Flurazepam) C Diazepam C Date:03/01/02ISR Number: 3877865-5Report Type:Expedited (15-DaCompany Report #HQ1014726FEB2002 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukoplakia Health Efexor Xr Lymphopenia Professional (Venlafaxine Neutropenia Other Hydrochloride, Capsule, Extended Release) PS ORAL 75 MG 1X PER 1 DAY Epilim (Valproate Sodium,) SS 600 MG 1X PER 1 DAY Targocid (Teicoplanin,) SS 400 MG 1X PER 1 DAY Zyprexa (Olanzapine,) SS 10 MG 1X PER 1 DAY Warfarin (Warfarin) C Date:03/01/02ISR Number: 3877868-0Report Type:Expedited (15-DaCompany Report #HQ1014226FEB2002 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Efexor (Venlafaxine Professional Hydrochloride, Other Unspec) PS ORAL 75 MG 1X PER 1 DAY 7 MON Olanzapine (Olanzapine,) SS 7.5 MG 1X PER 1 DAY 163 DAY Valproate Sodium (Valproate Sodium,) SS 1 G 1X PER 1 DAY 7 MON Celecoxib (Celecoxib) C Ranitidine (Ranitidine) C 24-Jun-2005 12:19 PM Page: 1803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/02ISR Number: 3878807-9Report Type:Expedited (15-DaCompany Report #A204048 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zoloft Tablets PS ORAL 50.00 MG Initial or Prolonged Depression Professional TOTAL:DAILY:O Required Diabetes Mellitus Company RAL Intervention to Drug Effect Decreased Representative Wellbutrin SS ORAL 300.00 MG Prevent Permanent Fatigue TOTAL:BID:ORA Impairment/Damage Fear L Gait Disturbance Zyprexa SS ORAL 10.00 Hallucination, Visual TOTAL:DAILY:O Hemianopia RAL Insomnia Date:03/04/02ISR Number: 3876626-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11735347 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Olanzapine PS ORAL White Blood Cell Count Professional Coversyl C Decreased Hctz C Date:03/04/02ISR Number: 3877210-5Report Type:Direct Company Report #CTU 162599 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Zyprexa 20mg PS ORAL 20MG PO HS Celexa 40mg SS ORAL 40MG PO HS Ranitidine C Magnesium Oxide C Niacin C Phenobarbital C Primidone C Asiprin C Furosemide C Neurontin C Dilantin C Haldol Decanoate C Date:03/04/02ISR Number: 3877891-6Report Type:Direct Company Report #USP 54771 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec 10mg(Cetirizine Hydrochloride) PS Pfizer Zyprexa 10mg (Olanzapine) SS Lilly Date:03/04/02ISR Number: 3878151-XReport Type:Expedited (15-DaCompany Report #US_020281605 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 15 MG Hypertriglyceridaemia Professional Weight Increased 24-Jun-2005 12:19 PM Page: 1804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/02ISR Number: 3878155-7Report Type:Expedited (15-DaCompany Report #USA020211020 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa-Oral Gastric Haemorrhage (Olanzapine) Gastrointestinal Disorder (Olanzapine) PS 2.5 MG/ IN Oedema THE EVENING Respiratory Disorder Nexium Salivary Hypersecretion (Esomeprazole) C Swelling Carafate Tooth Discolouration (Sucralfate) C Baclofen C Lamictal (Lamotrigine) C Topamax (Topiramate) C Zonegran (Zonisamide) C Synthroid (Levothyroxine Sodium) C Propranolol C Flonase (Fluticasone Propionate) C Miralax (Macrogol) C Date:03/04/02ISR Number: 3878225-3Report Type:Expedited (15-DaCompany Report #US_010872773 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Zyprexa (Olanzapine) Initial or Prolonged Exposure To Therapeutic Professional (Olanzapine) PS 20 MG/1 DAY Drugs Other Prozac (Fluoxetine) Depression (Fluoxetine Drug Effect Decreased Hydrochloride) SS 80 MG/1 DAY Premature Labour Celexa (Citalopram Vomiting Hydrobromide) C Remeron (Mirtazapine) C Multivitamins Nos (Multivitamins Nos) C Folate Sodium C Iron Sulfate C Date:03/04/02ISR Number: 3878720-7Report Type:Expedited (15-DaCompany Report #EWC010727733 Age:35 YR Gender:Male I/FU:F Outcome PT Hospitalization - Autoimmune Hepatitis Initial or Prolonged Diabetes Mellitus Disability Inadequate Control Diabetes Mellitus Insulin-Dependent Haemoglobin Urine Present Hepatic Steatosis Hyperventilation Ketoacidosis Liver Function Test Abnormal Microalbuminuria 24-Jun-2005 12:19 PM Page: 1805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Disorder Polydipsia Polyneuropathy Report Source Product Role Manufacturer Route Dose Duration Polyuria Foreign Olanzapine PS 15 MG/DAY Renal Impairment Health Deroxat (Paroxetine Respiratory Rate Professional Hydrochloride) C Increased Company Urine Ketone Body Present Representative Weight Increased Other Date:03/04/02ISR Number: 3878896-1Report Type:Expedited (15-DaCompany Report #US_020281592 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 10 MG Hyperlipidaemia Professional Lithium C Hypertriglyceridaemia Weight Increased Date:03/04/02ISR Number: 3878903-6Report Type:Expedited (15-DaCompany Report #US_020181124 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Consumer Zyprexa-Oral Initial or Prolonged Drug Abuser (Olanzapine) Drug Withdrawal Syndrome (Olanzapine) PS 10 MG/DAY Erectile Dysfunction Aspirin C Haematocrit Decreased Cogentin Haemoglobin Decreased (Benzatropine Keratoconjunctivitis Mesilate) C Sicca Levsin (Hyoscyamine Pain Sulfate) C Priapism Somnolence Date:03/04/02ISR Number: 3878907-3Report Type:Expedited (15-DaCompany Report #US_020281585 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine0 PS 12.5 MG Blood Glucose Increased Professional Lithium C Hypertriglyceridaemia Valproic Acid C Weight Increased Date:03/04/02ISR Number: 3878912-7Report Type:Expedited (15-DaCompany Report #US_020281582 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS ORAL 5 MG Blood Glucose Increased Professional Glycosylated Haemoglobin Increased Hypertriglyceridaemia Weight Increased 24-Jun-2005 12:19 PM Page: 1806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/02ISR Number: 3878915-2Report Type:Expedited (15-DaCompany Report #US_020281564 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 20 MG Diabetes Mellitus Professional Valproic Acid C Hyperlipidaemia Hypertriglyceridaemia Weight Decreased Date:03/04/02ISR Number: 3878936-XReport Type:Expedited (15-DaCompany Report #US_020281783 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa-Oral Blood Pressure Abnormal Health (Olanzapine) Heart Rate Decreased Professional (Olanzapine) PS 20 MG/DAY Pituitary Tumour Benign Company Impromen Vomiting Representative (Bromperidol) C Other Levotomin (Levomepromazine Maleate) C Gasmotin (Mosapride Citrate) C Lendormin (Brotizolam) C Date:03/04/02ISR Number: 3878953-XReport Type:Expedited (15-DaCompany Report #US_020281563 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 30 MG Diabetes Mellitus Professional Lithium C Hypertriglyceridaemia Weight Increased Date:03/04/02ISR Number: 3878956-5Report Type:Expedited (15-DaCompany Report #US_020281559 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Olanzapine-Oral Hyperlipidaemia Health (Olanzapine) PS 20 MG Hypertriglyceridaemia Professional Weight Increased Date:03/04/02ISR Number: 3878958-9Report Type:Expedited (15-DaCompany Report #US_020281597 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 20 MG Hyperlipidaemia Professional Hypertriglyceridaemia Weight Decreased 24-Jun-2005 12:19 PM Page: 1807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/02ISR Number: 3878962-0Report Type:Expedited (15-DaCompany Report #US_020281770 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Faeces Consumer Zyprexa-Oral Drooling (Olanzapine) Eye Disorder (Olanzapine) PS Sedation Lamictal Stevens-Johnson Syndrome (Lamotrigine) C Amoxicillin C Topiramate C Date:03/04/02ISR Number: 3878965-6Report Type:Expedited (15-DaCompany Report #US_020281603 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 10 MG Hypertriglyceridaemia Professional Weight Increased Date:03/04/02ISR Number: 3878977-2Report Type:Expedited (15-DaCompany Report #AU_020204700 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS Other Citalopram C Diazepam C Date:03/04/02ISR Number: 3878978-4Report Type:Expedited (15-DaCompany Report #US_020281664 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa-Oral Supraventricular Health (Olanzapine) Extrasystoles Professional (Olanzapine) PS 7.5 MG /DAY Company Representative Other Date:03/04/02ISR Number: 3878979-6Report Type:Expedited (15-DaCompany Report #US_020281759 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa-Oral Monoplegia Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 1808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/02ISR Number: 3878980-2Report Type:Expedited (15-DaCompany Report #US_020281780 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Vegetamin B C Rohypnol (Flunitrazepam) C Polycarbophyl Calcium C Ubretid (Distigmine Bromide) C Date:03/04/02ISR Number: 3878982-6Report Type:Expedited (15-DaCompany Report #FR_020200660 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Septal Defect Foreign Zyprexa-Oral Initial or Prolonged Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS Gastrointestinal Disorder Other Teralithe (Lithium Hypothyroidism Carbonate) C Hypotonia Neonatal Tercian Maternal Drugs Affecting (Cyamemazine) C Foetus Parkinane Neonatal Disorder (Trihexyphenidyl Neonatal Respiratory Hydrochloride) C Distress Syndrome Effexor Paresis (Venalafaxine Premature Rupture Of Hydrochloride) C Membranes Date:03/04/02ISR Number: 3878986-3Report Type:Expedited (15-DaCompany Report #US_020281594 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 15 MG Diabetes Mellitus Professional Lithium C Hypertriglyceridaemia Valproic Acid C Obesity ... C Date:03/04/02ISR Number: 3878990-5Report Type:Expedited (15-DaCompany Report #US_020281699 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Health Prozac-Oral Initial or Prolonged Maternal Drugs Affecting Professional (Fluoxetine) Foetus Other (Fluoxetine Neonatal Respiratory Hydrochloride) PS Depression Zyprexa-Oral (Olanzapine) (Olanzapine) SS Celexa (Citalopram Hydrobromide) C Remeron (Mirtazapine) C 24-Jun-2005 12:19 PM Page: 1809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/02ISR Number: 3878991-7Report Type:Expedited (15-DaCompany Report #US_020281610 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 20 MG Diabetes Mellitus Professional Valproic Acid C Hypertriglyceridaemia Nelfinavir C Date:03/04/02ISR Number: 3878994-2Report Type:Expedited (15-DaCompany Report #US_020281587 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Olanzapine-Oral Increased Health (Olanzapine) PS 10 MG Blood Glucose Abnormal Professional Hypertriglyceridaemia Weight Increased Date:03/04/02ISR Number: 3879033-XReport Type:Expedited (15-DaCompany Report #AU_020204732 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Olanzapine-Oral Initial or Prolonged Pneumonia Health (Olanzapine) PS 15 MG/DAY Sepsis Professional Zuclopethixol C Other Date:03/04/02ISR Number: 3879080-8Report Type:Expedited (15-DaCompany Report #US_020181261 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa-Oral Initial or Prolonged Anxiety Health (Olanzapine) Attention Professional (Olanzapine) PS 20 MG/DAY Deficit/Hyperactivity Company Contomin Disorder Representative (Chlorpromazine Condition Aggravated Other Hydrochloride) C Excitability Levotomin Hallucination (Levomepromazine Hypercholia Maleate) C Insomnia Silece Irritability (Flunitrazepam) C Persecutory Delusion Vegetamin A C Trihexyphenidyl Hydrochloride C Date:03/04/02ISR Number: 3879084-5Report Type:Expedited (15-DaCompany Report #GBS020210143 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Foreign Zyprexa-Oral Muscle Contractions Health (Olanzapine) Involuntary Professional (Olanzapine) PS 10 MG/2 DAY Tongue Disorder Other Diclofenac C Nivea Cream C 24-Jun-2005 12:19 PM Page: 1810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/02ISR Number: 3879105-XReport Type:Expedited (15-DaCompany Report #S02-FRA-00267-01 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Chest Sound Foreign Citalopram Initial or Prolonged Asthenia Health (Citalopram Enanthema Professional Hydrobromide) PS ORAL 30 MG QD PO Eosinophilia Other Tercian Exanthem (Cyamemazine) SS Hyperpyrexia Zyprexa (Olanzapine) SS ORAL 15 MG QD PO Liver Function Test Heptamyl (Heptaminol Abnormal Hydrochloride) SS ORAL 20 UNITS QD Lung Disorder PO Pleural Rub Stilnox (Zolpidem) SS ORAL 10 MG QD PO Psychomotor Retardation Parkinane Rash Maculo-Papular (Trihexyphenidyl Hydrochloride) SS ORAL 5 MG QD PO Depamide (Valpromide) SS ORAL 300 MG TID PO Sulfarlem (Anethole Trithione) SS ORAL 150 MG QD PO Normacol SS Date:03/04/02ISR Number: 3879117-6Report Type:Expedited (15-DaCompany Report #GBS020110061 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspepsia Foreign Zyprexa-Oral Initial or Prolonged Left Ventricular Failure Health (Olanzapine) Myocardial Infarction Professional (Olanzapine) PS 20 MG/DAY Company Nefazodone C Representative Other Date:03/04/02ISR Number: 3879119-XReport Type:Expedited (15-DaCompany Report #GBS020109990 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Foreign Zyprexa-Oral Antidiuretic Hormone Health (Olanzapine) Secretion Professional (Olanzapine) PS 12.5 MG/DAY Other Bendrofluazide C Atenolol C Date:03/04/02ISR Number: 3879120-6Report Type:Expedited (15-DaCompany Report #FR_020100599 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytolytic Hepatitis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Anafranil Representative (Clomipramine Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/02ISR Number: 3879132-2Report Type:Expedited (15-DaCompany Report #US_020281427 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Zyprexa-Oral Depressed Level Of Study (Olanzapine) Consciousness Health (Olanzapine) PS 20 MG/DAY Injury Asphyxiation Professional Lodopin ((Zotepine) C Urinary Incontinence Other Tolopelon (Timiperone) C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride) C Silece (Flunitrazepam) C Eurodin (Estazolam) C Vegetamin A C Adalat L (Nifedipine) C Date:03/04/02ISR Number: 3879140-1Report Type:Expedited (15-DaCompany Report #EWC011028709 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Olanzapine PS 1 MG/DAY Initial or Prolonged Nausea Study Tenormine (Atenolol) C Vomiting Health Skenan (Morphine Professional Sulfate) C Other Calcite D C Exelon (Rivastigmine Tartrate) C Motilium (Domperidone) C Umuline Profil 30 (Insulin Human Injection, Isophane) C Hydromorphone Hydrochloride C Date:03/04/02ISR Number: 3879184-XReport Type:Expedited (15-DaCompany Report #EWC000606949 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dilatation Ventricular Foreign Zyprexa-Oral Initial or Prolonged Echocardiogram Abnormal Health (Olanzapine) Lung Disorder Professional (Olanzapine) PS 15 MG/DAY Other Effexor (Venlafaxine Hydrochloride) C Rivotril (Clonazepam) C Date:03/04/02ISR Number: 3880982-7Report Type:Expedited (15-DaCompany Report #US_020281738 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Xigris (Drotrecogin Initial or Prolonged Overdose Professional Alfa (Activated) ) PS 35 UG/KG/HR Other Platelet Count Decreased Vancocin (Vancomycin 24-Jun-2005 12:19 PM Page: 1812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS Olanzapine-Oral (Olanzapine) SS Levophen (Norepnephrine Bitartrate) C Dopamine C Levaquin (Levofloxacin) C Elavil (Amitriptyline Hydrochloride) C Xanax (Alprazolam) C Celexa (Citalopram Hydrnbromide) C Reglan (Metoclopramide) C Norepinephrine C Date:03/05/02ISR Number: 3877412-8Report Type:Expedited (15-DaCompany Report #B0134019A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mouth Haemorrhage Zyban PS Glaxo Wellcome ORAL 150MG As Overdose directed Fluoxetine SS ORAL 20MG Per day Olanzapine SS ORAL 7.5MG Twice per day Aceprometazine + Meprobamate SS ORAL 1UNIT per day Anethole SS ORAL 6UNIT per day Zolpidem SS ORAL 1UNIT per day Loxapine SS ORAL 50MG Per day Cyamemazine C ORAL 25MG Three times per day Pristinamycin C ORAL Date:03/05/02ISR Number: 3879747-1Report Type:Direct Company Report #CTU 162805 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Olanzapine 7.5mg, Salivary Hypersecretion 10mg, 2.5mg Eli Lilly PS Eli Lilly ORAL 10MG Q AM 15MG QHS ORAL Lorazepam C Date:03/05/02ISR Number: 3880314-4Report Type:Direct Company Report #CTU 162790 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa 10 Mg PS 10 MG Q HS Required Diabetes Mellitus Luvox C Intervention to Depakote C Prevent Permanent Risperal C Impairment/Damage Topamax C 24-Jun-2005 12:19 PM Page: 1813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/02ISR Number: 3879988-3Report Type:Expedited (15-DaCompany Report #02P-062-0188749-00 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Ergenyl (Depakene) PS ORAL 300 MG , 1 IN Initial or Prolonged Pain In Extremity Health 1 D, PER ORAL Thrombosis Professional Maprotiline Other Hydrochoride SS ORAL 50 MG , 1 IN 1 D, PER ORAL Olanzapine SS ORAL 2.5 MG, 1 IN 1 D, PER ORAL Tamsulosin Hydrochloride SS ORAL 0.4 MG, 1 IN 1 D, PER ORAL Flurazepam C Diazepam C Date:03/06/02ISR Number: 3890593-5Report Type:Periodic Company Report #A200685 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Increased Professional TOTAL:BID:ORA Amenorrhoea L Hypercholesterolaemia Zyprexa SS Tremor Tegretol Xr C Vomiting Centrum Vit Weight Decreased Supplement C Caltrate C Date:03/07/02ISR Number: 3880564-7Report Type:Expedited (15-DaCompany Report #EWC020229991 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Central Pontine Foreign Zyprexa-Oral Initial or Prolonged Myelinolysis Health (Olanzapine) Disability Coma Professional (Olanzapine) PS 10 MG/DAY Hypertension Ameride C Hyponatraemia Modecate (Fluphenazine Decanoate) C Tranxilium (Clorazepate Dipotassium) C Date:03/07/02ISR Number: 3880566-0Report Type:Expedited (15-DaCompany Report #FR_020200693 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Foreign Zyprexa-Oral Localised Oedema Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Floxyfral (Fluvoxamine Maleate) C Temesta (Lorazepam) C Imovane (Zopiclone) C 24-Jun-2005 12:19 PM Page: 1814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/02ISR Number: 3880567-2Report Type:Expedited (15-DaCompany Report #FR_020200690 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Zyprexa-Oral Hepatocellular Damage Health (Olanzapine) Nausea Professional (Olanzapine) PS 10 MG/DAY Vomiting Depamide (Valpromide) C Date:03/07/02ISR Number: 3880570-2Report Type:Expedited (15-DaCompany Report #EWC020230016 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Hyperglycaemia Health (Olanzapine) Intentional Misuse Professional (Olanzapine) PS 20 MG Other Propavan (Propiomazine Maleate) C Imovan (Zopiclone) C Date:03/07/02ISR Number: 3880571-4Report Type:Expedited (15-DaCompany Report #EWC020230012 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Complications Of Maternal Foreign Olanzapine-Oral Exposure To Therapeutic Health (Olanzapine) PS Drugs Professional Cipramil (Citalopram Maternal Drugs Affecting Company Hydrobromide) C Foetus Representative Stelazine Precipitate Labour (Trifluoperazine Pregnancy Hydrochloride) C Date:03/07/02ISR Number: 3880613-6Report Type:Expedited (15-DaCompany Report #CA_020104677 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa (Olanzapine) Erosive Oesophagitis Health (Olanazapine) PS 30 MG Splenomegaly Professional Seroquel C Sudden Death Company Effexor-Xr Weight Increased Representative (Venlafaxine White Blood Cell Count Other Hydrochloride) C Increased Date:03/07/02ISR Number: 3880659-8Report Type:Expedited (15-DaCompany Report #US_020181261 Age:51 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Anger Attention Deficit/Hyperactivity Disorder Excitability Hallucination Insomnia 24-Jun-2005 12:19 PM Page: 1815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Persecutory Delusion Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Contomin Representative (Chlorpromazine Other Hydrochloride) C Levotomin (Levomepromazine Maleate) C Silece (Flunitrazepam) C Vegetamin A C Trihexyphenidyl Hydrochloride C Date:03/07/02ISR Number: 3880703-8Report Type:Expedited (15-DaCompany Report #EWC000606949 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Zyprexa-Oral Initial or Prolonged Dilatation Ventricular Health (Olanzapine) Lung Disorder Professional (Olanzapine) PS 15 MG/DAY Other Efexor (Venlafaxine Hydrochloride) C Rivotril (Clonazepam) C Date:03/07/02ISR Number: 3880707-5Report Type:Expedited (15-DaCompany Report #EWC011129071 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Abnormal Foreign Zyprexa-Oral Blood Pressure Diastolic Health (Olanzapine) Increased Professional (Olanzapine) PS 10 MG/DAY Blood Thyroid Stimulating Company Zestril (Lisinopril) C Hormone Abnormal Representative Eucardic Cardiac Disorder Other (Carvedilol) C Cardiomegaly Furosemide C Congestive Cardiomyopathy Losec (Omeprazole) C Diabetes Mellitus Non-Insulin-Dependent Electrocardiogram St-T Segment Abnormal Gamma-Glutamyltransferase Abnormal Haemoglobin Decreased Heart Rate Increased Mitral Valve Incompetence Tricuspid Valve Incompetence Urine Flow Decreased Ventricular Extrasystoles Ventricular Hypokinesia Weight Increased White Blood Cell Disorder 24-Jun-2005 12:19 PM Page: 1816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/02ISR Number: 3881053-6Report Type:Expedited (15-DaCompany Report #US_020281894 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Embolism Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:03/07/02ISR Number: 3881083-4Report Type:Expedited (15-DaCompany Report #US_010769970 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Prozac-Oral Initial or Prolonged Fatigue (Fluoxetine) (Fluoxetine Hydrochloride) PS 40 MG/DAY Prozac Weekly-Weekly (Once A Week Formualtion) (Flu SS 90 MG/1 WEEK 1 MON Zyprexa-Oral (Olanzapine) (Olanzapine) SS 15 MG/DAY 2 MON Risperdal (Risperidone) C Date:03/07/02ISR Number: 3881090-1Report Type:Expedited (15-DaCompany Report #US_020281699 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Health Prozac-Oral Initial or Prolonged Maternal Drugs Affecting Professional (Fluoxetine) Foetus Other (Fluoextine Neonatal Respiratory Hydrochloride) PS Distress Syndrome Zyprexa-Oral (Olanzapine)(Olanzap ine) SS Celexa(Citalopram Hydrobromide) C Remeron(Mirtazapine) C Date:03/07/02ISR Number: 3881200-6Report Type:Expedited (15-DaCompany Report #US_010872773 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Zyprexa-Oral Initial or Prolonged Exposure To Therapeutic Professional (Olanzapine) Drugs Other (Olanzapine) PS 20 MG/1 DAY Depression Prozac-Oral Maternal Drugs Affecting (Fluoxetine) Foetus (Fluoxetine Neonatal Respiratory Hydrochloride) SS 80 MG/1 DAY Depression Celexa (Citalopram Vomiting Hydrochloride) C Remeron (Mirtazapine) C Multivitamins Nos (Multivitamins Nos) C Folate Sodium C 24-Jun-2005 12:19 PM Page: 1817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Iron Sulfate C Date:03/07/02ISR Number: 3881315-2Report Type:Expedited (15-DaCompany Report #DE_020208039 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zyprexa Oral Initial or Prolonged Hypotension Health (Olanzapine) Loss Of Consciousness Professional (Olanzapine) PS 10 MG/DAY Pulse Absent Other Decentan Sinus Bradycardia (Perphenazine) C Tachycardia Dipiperon (Pipamperone) C Date:03/07/02ISR Number: 3881365-6Report Type:Expedited (15-DaCompany Report #DE_020208035 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa-Oral Initial or Prolonged Hyposthenuria Health (Olanzapine) Loss Of Consciousness Professional (Olanzapine) PS 2.5 MG/DAY Syncope Other Aurorix(Moclobemide) C Antraomeprazole) C Cordanum(Talinolol) C Plavix(Clopidogrel Sulfate) C Delix(Ramipril) C Date:03/07/02ISR Number: 3881366-8Report Type:Expedited (15-DaCompany Report #DE_020208026 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Oedema Peripheral Health (Olanzapine) Pain In Extremity Professional (Olanzapine) PS 2.5 MG/DAY Other Ludiomil(Maprotiline Hydrochloride) C Ergenyl(Valproate Sodium) C Alna(Tamsulosin Hydrochloride) C Staurodorm Neu(Flurazepam) C Diazepam C Date:03/07/02ISR Number: 3881367-XReport Type:Expedited (15-DaCompany Report #DE_020208048 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Zyprexa-Oral Head Injury Health (Olanzapine) Syncope Professional (Olanzapine) PS 10 MG/DAY Traumatic Haematoma Other Quilonium-R (Lithium Carbonate) C L-Thyroxin(Levothyro xine Sodium) C Ass C 24-Jun-2005 12:19 PM Page: 1818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propanolol C Diazepam C Docentan(Perphenazin e) C Tavor(Lorazepam) C Date:03/07/02ISR Number: 3881368-1Report Type:Expedited (15-DaCompany Report #DE_020208089 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Breast Neoplasm Foreign Zyprexa-Oral Initial or Prolonged Blood Prolactin Increased Health (Olanzapine) Cancer Pain Professional (Olanzapine) PS 12.5 MG/DAY Other Tavor(Lorazepam) C Date:03/07/02ISR Number: 3881369-3Report Type:Expedited (15-DaCompany Report #DE_020208056 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:03/07/02ISR Number: 3881389-9Report Type:Expedited (15-DaCompany Report #US_020281927 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Cancer Metastatic Foreign Olanzapine-Oral Pneumonia Study (Olanzapine) PS 10 MG DAY Respiratory Failure Health Impromen Professional (Bromperidol) C Other Cremin (Mosapramine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Barnetil (Sultopride) C Levotomin (Levopromazine Maleate) C Symmetrel (Amantadine Hydrochloride) C Hiberna (Promethazine Hydrochloride) C Halcion (Triazolam) C Gastrom (Ecabet Monosodium) C Gascon (Dimeticone) C Selbex (Teprenone) C Marzulene S C Magnesium Oxide C Bio Three C Pursennid (Senna Leaf) C Chinese Medicine C 24-Jun-2005 12:19 PM Page: 1819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/02ISR Number: 3881392-9Report Type:Expedited (15-DaCompany Report #DE_020207981 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Foreign Zyprexa-Oral Initial or Prolonged Red Blood Cell Count Health (Olanzapine) Decreased Professional (Olanzapine) PS 10 MG/DAY White Blood Cell Count Other Dipiperon Decreased (Pipamperone) C Date:03/07/02ISR Number: 3881394-2Report Type:Expedited (15-DaCompany Report #EWC020230041 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Olanzapine Oral Health (Olanzapine) PS 20 MG / DAY Professional Valproate Sodium C Company Representative Other Date:03/07/02ISR Number: 3881396-6Report Type:Expedited (15-DaCompany Report #EWC020230052 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Zyprexa-Oral Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 5 MG/ DAY Other Lasix (Furosemide) C Madopar C Triatec (Ramipril) C Spectrum (Ceftazidime) C Calciparina Choay (Heparin Calcium) C Date:03/07/02ISR Number: 3881398-XReport Type:Expedited (15-DaCompany Report #DE_02028038 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Gamma-Glutamyltransferase Professional (Olanzapine) PS 20 MG/DAY Increased Other Stangyl Gingival Bleeding (Trimipramine Liver Function Test Maleate) C Abnormal Atosil Mouth Haemorrhage (Isopromethazine Neutropenia Hydrochloride) C Thrombocytopenia Imurek (Azathioprine) C Mono Embolex (Heparin) C 24-Jun-2005 12:19 PM Page: 1820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/02ISR Number: 3881439-XReport Type:Expedited (15-DaCompany Report #USA020211481 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Consumer Zyprexa Oral Aspiration (Olanzapine) Coma (Olanzapine) PS Diabetes Mellitus Inadequate Control Dysphagia Labile Blood Pressure Date:03/07/02ISR Number: 3881440-6Report Type:Expedited (15-DaCompany Report #USA020211436 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Date:03/07/02ISR Number: 3881441-8Report Type:Expedited (15-DaCompany Report #USA020211401 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Pancreatitis Professional (Olanzapine) Schizophrenia (Olanzapine) PS 12.5 MG/DAY Treatment Noncompliance Vomiting Date:03/08/02ISR Number: 3890530-3Report Type:Periodic Company Report #US_011075592 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Spinal Osteoarthritis Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 50 MG DAY Norvasc (Amlodipin E Besilate) C Ecotrin (Acetysalicylic Acid) C Date:03/08/02ISR Number: 3890531-5Report Type:Periodic Company Report #US_011075033 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lumbar Vertebral Fracture Study Olanzapine PS 18 MG/DAY Hospitalization - Road Traffic Accident Health Fluoxetine(Fluoxetin Initial or Prolonged Professional e Hydrochloride) SS 75 MG/DAY Acetaminophen C Acetylsalicylic Acid C 24-Jun-2005 12:19 PM Page: 1821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/02ISR Number: 3890532-7Report Type:Periodic Company Report #US_011074843 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Olanzapine PS 1 MG Initial or Prolonged Sinus Bradycardia Professional Fluoxetine (Fluoxetine Hydrochloride) SS 5 MG Monopril (Fosinopril Sodium) C Detrol (Tolterodine L-Tartrate) C Atenolol C Date:03/08/02ISR Number: 3890533-9Report Type:Periodic Company Report #US_010974190 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 18 MG AT Initial or Prolonged Health BEDTIME Professional Fluoxetine (Fluoxetine Hydrochloride) SS 75 MG AT BEDTIME Date:03/08/02ISR Number: 3890534-0Report Type:Periodic Company Report #US_010974020 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Congestive Professional Prozac (Fluoxetine Somnolence Hydrochoride) SS 10 MG/1 DAY Gabapentin C Klonopin (Clonazepam) C Alprazolam C Lorazepam C Depakote (Valproate Semisodium0 C Date:03/08/02ISR Number: 3890535-2Report Type:Periodic Company Report #US_010973707 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Intentional Misuse Professional Prozac (Fluoxetine Suicide Attempt Company Hydrochloride) SS Representative Date:03/11/02ISR Number: 3881170-0Report Type:Direct Company Report #CTU 163125 Age:80 YR Gender:Female I/FU:I Outcome PT Death Coma Hospitalization - Convulsion Initial or Prolonged Nervous System Disorder Pneumonia Aspiration Status Epilepticus 24-Jun-2005 12:19 PM Page: 1822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Zyprexa 2.5mg PS ORAL 2.5MG BID ORAL Alprazolam SS ORAL ? QD1X2WK,DC ORAL Date:03/12/02ISR Number: 3881610-7Report Type:Direct Company Report #CTU 163188 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Acute Zyprexa 20mg PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:03/14/02ISR Number: 3882439-6Report Type:Direct Company Report #CTU 163349 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Zyprexa PS ORAL 20MG PO HS 5 DAY Initial or Prolonged Haloperidol C Ativan C Date:03/14/02ISR Number: 3882514-6Report Type:Expedited (15-DaCompany Report #A0162401A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Zyban PS Glaxo Wellcome ORAL 150MG Per day 1 WK Initial or Prolonged Drug Ineffective Professional Topamax SS UNKNOWN Psychotic Disorder Zyprexa SS UNKNOWN Klonopin SS UNKNOWN 1MG Unknown Date:03/14/02ISR Number: 3882730-3Report Type:Direct Company Report #CTU 163381 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Seroquel PS ORAL PO Zyprexa SS ORAL PO Prolixin C Cogentin C Date:03/14/02ISR Number: 3882731-5Report Type:Direct Company Report #CTU 163382 Age:31 YR Gender:Male I/FU:I Outcome PT Death Acute Respiratory Hospitalization - Distress Syndrome Initial or Prolonged Anorexia Other Blood Glucose Increased Blood Triglycerides Increased Cardiopulmonary Failure 24-Jun-2005 12:19 PM Page: 1823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dry Mouth Ketoacidosis Lipids Increased Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Zyprexa 7.5mg PS DAILY Pancreatitis Perph C Pollakiuria Benz C Renal Failure Traz C Thirst Vision Blurred Weight Decreased Date:03/14/02ISR Number: 3883753-0Report Type:Expedited (15-DaCompany Report #US_010565970 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Study Zyprexa-Oral Belligerence Consumer (Olanzapine) Delusion Health (Olanzapine) PS 22.5 MG/DAY Hallucination Professional Depakote (Valproate Obsessive-Compulsive Semisodium) C Disorder Tegretol Psychotic Disorder (Carbamazepine) C Tachycardia Trileptal (Oxcarbazepine) C Date:03/14/02ISR Number: 3883827-4Report Type:Expedited (15-DaCompany Report #01-1953 FOL#1 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Loxitane (Loxapac) Hospitalization - Somnolence Health Capsules, Wyeth Initial or Prolonged Professional Ayerst PS Wyeth Ayerst ORAL 15 MG 1 X PER Company 1 DAY, ORAL 305 DAY Representative Risperdal (Risperidone) SS ORAL 500 UG 1 X PER 1 DAY, ORAL 28 DAY Serenase (Haloperidol) SS ORAL 2 MG 1 X PER 1 DAY, ORAL 305 DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG 1 X PER 1 DAY, ORAL 301 DAY Date:03/14/02ISR Number: 3883846-8Report Type:Expedited (15-DaCompany Report #US_020181029 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Foreign Zyprexa-Oral(Olanzap Initial or Prolonged Haematuria Health ine)(Olanzapine0 PS 20 MG/DAY Palpitations Professional Lithium C Petechiae Other Clonazepam C Platelet Count Decreased Purpura Salivary Hypersecretion 24-Jun-2005 12:19 PM Page: 1824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/02ISR Number: 3883848-1Report Type:Expedited (15-DaCompany Report #US_011076156 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Fall Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Contomin(Chlorpromaz Representative ine Hydrochloride) C Other Risperdal(Risperidon e) C Artane(Trihexyphenid yl Hydrochloride) C Artane(Trihexyphenid yl Hydrochloride) C Tasmolin(Bipriden) C Selbex(Teprenone) C Levotomin(Levomeprom azine Maleate) C Rohypnol(Flunitrazep am) C Seroquel C Date:03/14/02ISR Number: 3883849-3Report Type:Expedited (15-DaCompany Report #DE_020107885 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Foreign Zyprexa-Oral Venous Thrombosis Limb Health (Olanzapine0 Professional (Olanzapine0 PS 2.5 MG/DAY Other Remergil(Mirtazapine ) C Trevilor(Venlafaxine Hydrochloride) C Date:03/14/02ISR Number: 3883850-XReport Type:Expedited (15-DaCompany Report #DE_020107884 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Foreign Zyprexa-Oral(Olanzap Thrombosis Health ine) (Olanzapine) PS 5 MG/DAY Professional Tagonis(Paroxetine Other Hydrochloride) C Tafil(Alprazolam) C Date:03/14/02ISR Number: 3883935-8Report Type:Expedited (15-DaCompany Report #USA020211601 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa-Oral Initial or Prolonged Pregnancy Professional (Olanzapine) Schizoaffective Disorder (Olanzapine) PS 15 MG/DAY 80 MON 24-Jun-2005 12:19 PM Page: 1825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/02ISR Number: 3883936-XReport Type:Expedited (15-DaCompany Report #USA020211797 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebothrombosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:03/14/02ISR Number: 3883972-3Report Type:Expedited (15-DaCompany Report #USA020211528 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Failure Health Zyprexa-Oral Other Neuroleptic Malignant Professional (Olanzapine) Syndrome Company (Olanzapine) PS Representative Clozaril (Clozapine) C Date:03/14/02ISR Number: 3883977-2Report Type:Expedited (15-DaCompany Report #US_010361622 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Health Zyprexa-Oral Initial or Prolonged Pregnancy Professional (Olanzapine) Psychotic Disorder Company (Olanzapine) PS 2.5 MG/DAY Representative Date:03/14/02ISR Number: 3883988-7Report Type:Expedited (15-DaCompany Report #DE_020208129 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration International Normalised Foreign Zyprexa-Oral Ratio Increased Health (Olanzapine) Professional (Olanzapine) PS 10 MG/ DAY Other Falithrom (Phenprocoumon) C Date:03/14/02ISR Number: 3883989-9Report Type:Expedited (15-DaCompany Report #FR_020100568 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Other Increased Gamma-Glutamyltransferase Increased Liver Disorder Prothrombin Time Prolonged 24-Jun-2005 12:19 PM Page: 1826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/02ISR Number: 3883992-9Report Type:Expedited (15-DaCompany Report #US_020382224 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Date:03/14/02ISR Number: 3884123-1Report Type:Expedited (15-DaCompany Report #USA020211791 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Health Zyprexa-Oral Professional (Olanzapine (Olanzapine) PS Date:03/14/02ISR Number: 3884214-5Report Type:Expedited (15-DaCompany Report #US_020282152 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Study (Olanzapine) PS 5 MG/1 DAY Aspartate Health Haloperidol C Aminotransferase Professional Timiperone C Increased Other Tasmolin (Biperiden) C Blood Lactate Triazolam C Dehydrogenase Increased Bezafibrate C Condition Aggravated Forsenid (Sennoside Gamma-Glutamyltransferase A+B) C Increased Mania Schizophrenia, Paranoid Type Date:03/14/02ISR Number: 3884216-9Report Type:Expedited (15-DaCompany Report #US_020282163 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Foreign Olanzapine-Oral Initial or Prolonged Increased Study (Olanzapine) PS 20 MG/DAY Hallucination, Auditory Health Seranace Persecutory Delusion Professional (Haloperidol) C Other Chlorpromazine C Date:03/14/02ISR Number: 3884217-0Report Type:Expedited (15-DaCompany Report #DE_020208110 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Zyprexa-Oral Hearing Impaired Health (Olanzapine) Hepatic Steatosis Professional (Olanzapine) PS 5 MG/DAY Pyrexia Other Cipramil (Citalopram Vasculitis Hydrobromide) C Viral Infection Weight Increased 24-Jun-2005 12:19 PM Page: 1827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/02ISR Number: 3884218-2Report Type:Expedited (15-DaCompany Report #US_020382240 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Foreign Zyprexa-Oral Initial or Prolonged Asthenia Literature (Olanzapine) Blood Gases Abnormal Health (Olanzapine) PS 5 MG/DAY 18 MON Congestive Cardiomyopathy Professional Cough Other Dehydration Dilatation Ventricular Dyspnoea Ejection Fraction Decreased Fibrosis Inflammation Oedema Peripheral Pyrexia Weight Increased Date:03/14/02ISR Number: 3884220-0Report Type:Expedited (15-DaCompany Report #CA_020204815 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Olanzapine-Oral Thrombocytopenia Study (Olanzapine) PS Health Professional Date:03/14/02ISR Number: 3884222-4Report Type:Expedited (15-DaCompany Report #EWC020230051 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Haloperidol C Date:03/14/02ISR Number: 3884223-6Report Type:Expedited (15-DaCompany Report #DE_020308171 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Cipramil (Citalopram Hydrobromide) C Carbamazepine C Date:03/14/02ISR Number: 3884224-8Report Type:Expedited (15-DaCompany Report #DE_020208130 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Zyprexa-Oral International Normalised Health (Olanzapine) Ratio Increased Professional (Olanzapine) PS 5 MG/DAY Other Marcumar (Phenprocoumon) C 24-Jun-2005 12:19 PM Page: 1828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sepram (Citalopram Hydrobromide) C Diazepam C Dilatrend (Carvedilol) C Date:03/14/02ISR Number: 3884259-5Report Type:Expedited (15-DaCompany Report #US_020282087 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Foreign Olanzapine-Oral Hospitalization - Gastric Ulcer Haemorrhage Study (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Health Cremin (Mosapramine Professional Hydrochloride) C Other Gramalil (Tiapride Hydrochloride) C Tasmolin (Biperiden) C Trihexyphenidyl Hydrochloride C Tsukushi Am C Chinese Medicine C Sennoside A C Rohypnol (Flunitrazepam) C Eurodin (Estazolam) C Barnetil (Sultopride) C Hirnamin (Levomepromazine) C Depas (Etizolam) C Date:03/14/02ISR Number: 3884271-6Report Type:Expedited (15-DaCompany Report #US_020281783 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa-Oral First Degree Health (Olanzapine) Heart Rate Decreased Professional (Olanzapine) PS 20 MG DAY Vomiting Company Impromen Representative (Bromperidol) C Other Levotomin (Levomepromazine Maleate) C Gasmotin (Mosapride Citrate) C Lendormin (Brotizolam) C Date:03/14/02ISR Number: 3884273-XReport Type:Expedited (15-DaCompany Report #US_020281780 Age:32 YR Gender:Female I/FU:F Outcome PT Other Atrioventricular Block Complete Condition Aggravated Electrocardiogram Qt Shortened Myocardial Ischaemia 24-Jun-2005 12:19 PM Page: 1829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Retention Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 12.5 MG DAY Other Vegetamin B C Rohypnol (Flunitrazepam) C Polycarbophil Calcium C Ubretid (Distigmine Bromide) C Wintermin (Chlorpromazine Hydrochloride) C Serenace (Haloperidol) C Risperdal (Risperidone) C Lodopin (Zotepine) C Biperiden C Sennoside A C Quetiapine Fumarate C Date:03/14/02ISR Number: 3884275-3Report Type:Expedited (15-DaCompany Report #US_020281664 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Zyprexa-Oral Atrioventricular Block Health (Olanzapine) Bradycardia Professional (Olanzapine) PS 7.5 MG DAY Condition Aggravated Company Anginal Supraventricular Representative (Dipyridamole) C Extrasystoles Other Mexitil (Mexiletine Hydrochloride) C Sennoside A C Pyrethia (Promethazine Hydrochloride) C Eurodin (Estazolam) C Date:03/15/02ISR Number: 3884367-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperdal (Tablet) Sudden Death Health (Risperidone) PS SEE IMAGE FOR Professional DOSAGE TEXT & THERAPY DATES Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS VARING DOSES FROM 25 TO 300 MG DAILY Quetiapine Fumarate (Quetiapine Fumarate) SS VARING DOSES 24-Jun-2005 12:19 PM Page: 1830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report FROM 50 TO 600 MG DAILY Olanzapine (Olanzapine) SS VARING DOSES FROM 5 TO 10 MG DAILY Flunitrazepam (Flunitrazepam) SS VARING DOSE FROM 2 MG TO 4 MG Levomepromazine (Levomepromazine) SS VARING DOSE FROM 10 MG TO 25 MG Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Teprenone (Teprenone) C Date:03/15/02ISR Number: 3884621-0Report Type:Expedited (15-DaCompany Report #200210922BCC Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Consumer Aleve (Naproxen Initial or Prolonged Phosphokinase Increased Other Sodium) PS ORAL 4400 MG ONCE Myocardial Ischaemia ORAL Somnolence Depakote Tablets SS Zyprexa (Olanzapine) SS Date:03/19/02ISR Number: 3885402-4Report Type:Expedited (15-DaCompany Report #DE_020308199 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening C-Reactive Protein Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Infection Professional (Olanzapine) PS 5 MG/DAY Pyrexia Other Sifrol (Pramipezole Dihydrochloride) C Nacom C Arelix (Piretanide) C Date:03/19/02ISR Number: 3885424-3Report Type:Expedited (15-DaCompany Report #DE_020308190 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) Chromaturia Professional (Olanzapine) PS 10 MG/2 DAY Loss Of Consciousness Other Xanef (Enalapril Pyrexia Maleate) C Rhabdomyolysis Dytide H C Tachycardia Norvasc (Amlodipine Besilate) C 24-Jun-2005 12:19 PM Page: 1831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diazepam C Tavor (Lorazepam) C Akineton (Biperiden Hydrochloride) C Ciatyl-Z Acuphase (Zuclopenthixol Acetate) C Date:03/19/02ISR Number: 3885430-9Report Type:Expedited (15-DaCompany Report #US_020281566 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Zyprexa-Oral Other Angina Pectoris Health (Olanzapine) Asthma Professional (Olanzapine) PS 20 MG/DAY Cerebrovascular Disorder Company Akineton (Riperiden Embolism Representative Hydrochloride) C Epilepsy Other Etizolam C Hypotonia Tegretol Phlebothrombosis (Carbamazepine) C Pulmonary Hypertension Risperdal Respiratory Arrest (Risperidone) C Respiratory Disorder Ethyl Loflazepate C Shock Neoperidol C Sleep Apnoea Syndrome Snoring Somnolence Ventricle Rupture Weight Increased Date:03/19/02ISR Number: 3885432-2Report Type:Expedited (15-DaCompany Report #US_011279569 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa-Oral Gastric Cancer Health (Olanzapine) Hypoglycaemia Professional (Olanzapine) PS 10 MG/DAY Pancreatic Carcinoma Company Seroquel C Representative Other Date:03/19/02ISR Number: 3885435-8Report Type:Expedited (15-DaCompany Report #US_020382423 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 1832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/02ISR Number: 3885437-1Report Type:Expedited (15-DaCompany Report #FR_020300746 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Hypotonia Neonatal Health (Olanzapine) Jaundice Neonatal Professional (Olanzapine) PS Neonatal Respiratory Other Tercian Distress Syndrome (Cyamemazine) C Patent Ductus Arteriosus Celestene Premature Baby (Betamethasone) C Somnolence Neonatal Loxen (Nicardipine Hydrochloride) C Date:03/19/02ISR Number: 3885439-5Report Type:Expedited (15-DaCompany Report #FR_020300744 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS 15 MG/DAY Drugs Other Tercian Gestational Diabetes (Cyamemazine) C Hypertension Pre-Eclampsia Pregnancy Date:03/19/02ISR Number: 3885509-1Report Type:Expedited (15-DaCompany Report #USA020110741 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Penis Disorder Health Zyprexa-Oral Initial or Prolonged Post Procedural Professional (Olanzapine) Disability Complication Company (Olanzapine) PS 15 MG/DAY Other Priapism Representative Ativan (Lorazepam) C Thrombosis Prolixin Decanoate (Fluphenazine Decanoate) C Benadryl (Diphenhydramine Hydrochloride) C Date:03/19/02ISR Number: 3885512-1Report Type:Expedited (15-DaCompany Report #USA020311943 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY 6 MON Representative Depakote (Valproate Semisodium) C Date:03/19/02ISR Number: 3885515-7Report Type:Expedited (15-DaCompany Report #USA020311969 Age: Gender:Male I/FU:I Outcome PT Report Source Death Death Health Professional 24-Jun-2005 12:19 PM Page: 1833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Date:03/19/02ISR Number: 3885520-0Report Type:Expedited (15-DaCompany Report #US_010768842 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Consumer Zyprexa-Oral Caesarean Section (Olanzapine) Twin Pregnancy (Olanzapine) PS Uterine Leiomyoma Date:03/19/02ISR Number: 3885524-8Report Type:Expedited (15-DaCompany Report #US_020382317 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrested Labour Health Prozac-Oral Initial or Prolonged Bronchiolitis Professional (Fluoxetine) Caesarean Section (Fluoxetine Mania Hydrochloride) PS Maternal Drugs Affecting Humalog-. (Lispro) SS Foetus Zyprexa-Oral Pregnancy (Olanzapine) Premature Baby (Olanzapine) SS Transient Tachypnoea Of The Newborn Date:03/19/02ISR Number: 3885530-3Report Type:Expedited (15-DaCompany Report #USA020211749 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Bullous Health Zyprexa-Oral Lymphocyte Count Professional (Olanzapine) Decreased (Olanzapine) PS 10 MG/DAY 1 YR Neutrophil Count Lithobid (Lithium Increased Carbonate) C Red Blood Cell Klonopin Sedimentation Rate (Clonazepam) C Increased Selenium C Date:03/19/02ISR Number: 3885834-4Report Type:Expedited (15-DaCompany Report #DE_020208158 Age:73 YR Gender:Male I/FU:I Outcome PT Death Atrial Tachycardia Hospitalization - Cardiac Arrest Initial or Prolonged Cardiac Failure Cardiovascular Disorder Hypokalaemia 24-Jun-2005 12:19 PM Page: 1834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infarction Normochromic Normocytic Anaemia Report Source Product Role Manufacturer Route Dose Duration Pneumonia Foreign Zyprexa-Oral Psychotic Disorder Health (Olanzapine) Pyrexia Professional (Olanzapine) PS 10 MG/DAY Restlessness Other Benzodiazepine C Rhabdomyolysis Truxal (Chlorprothixene Hydrochloride) C Date:03/19/02ISR Number: 3885836-8Report Type:Expedited (15-DaCompany Report #FR_020300750 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Unilateral Foreign Zyprexa-Oral Eye Haemorrhage Health (Olanzapine) Retinal Detachment Professional (Olanzapine) PS 27.5 MG /DAY Other Tegretol (Carbamazepine) C Teralithe (Lithium Carbonate) C Date:03/19/02ISR Number: 3885874-5Report Type:Expedited (15-DaCompany Report #USA020110549 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Health Zyprexa-Oral Epistaxis Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY Representative Clonidiine C Adderall C Date:03/19/02ISR Number: 3885878-2Report Type:Expedited (15-DaCompany Report #USA020110554 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Lithium C Wellbutrin Sr (Amfebutamone Hydrochloride) C Date:03/19/02ISR Number: 3885939-8Report Type:Expedited (15-DaCompany Report #EWC011129086 Age:45 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased 24-Jun-2005 12:19 PM Page: 1835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Steatosis Jaundice Cholestatic Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Representative Date:03/19/02ISR Number: 3885940-4Report Type:Expedited (15-DaCompany Report #FR_011200434 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Depo Provera (Medroxyprogesterone Acetate) C Date:03/19/02ISR Number: 3885941-6Report Type:Expedited (15-DaCompany Report #EWC000306074 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Literature (Olanzapine) PS 5 MG/1 DAY Aspartate Health Haldol(Haloperidol) C Aminotransferase Professional Increased Other Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Gases Abnormal Blood Lactate Dehydrogenase Increased Cardiac Failure Congestive Cardiomyopathy Dehydration Difficulty In Walking Dilatation Ventricular Face Oedema Hypoproteinaemia Inflammation Mitral Valve Incompetence Myocardial Fibrosis Pyrexia Viral Infection Date:03/19/02ISR Number: 3885942-8Report Type:Expedited (15-DaCompany Report #US_020382240 Age:45 YR Gender:Male I/FU:F Outcome PT Hospitalization - Ascites Initial or Prolonged Asthenia Blood Gases Abnormal Cough Dehydration Dilatation Ventricular 24-Jun-2005 12:19 PM Page: 1836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Inflammation Myocardial Fibrosis Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Foreign Zyprexa-Oral Pyrexia Literature (Olanzapine) Weight Increased Health (Olanzapine) PS 5 MG/ DAY 18 MON Professional Date:03/19/02ISR Number: 3885943-XReport Type:Expedited (15-DaCompany Report #DE_020107769 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Date:03/19/02ISR Number: 3885944-1Report Type:Expedited (15-DaCompany Report #DE_020107884 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Foreign Zyprexa-Oral Thrombosis Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Tagonis (Paroxetine Hydrochloride) C Tafil (Alprazolam) C Date:03/19/02ISR Number: 3885955-6Report Type:Expedited (15-DaCompany Report #USA020110589 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apathy Consumer Zyprexa-Oral Other Aspartate (Olanzapine) Aminotransferase Abnormal (Olanzapine) PS 2.5 MG/2 DAY Blood Urea Increased Aricept (Donepezil Difficulty In Walking Hydrochloride) C Gastric Ulcer Haemorrhage Lorazepam C Haematocrit Decreased Vioxx (Rofecoxib) C Haemoglobin Decreased Listless Red Blood Cell Count Decreased Urinary Tract Infection Weight Decreased Date:03/19/02ISR Number: 3885959-3Report Type:Expedited (15-DaCompany Report #A205737 Age:61 YR Gender:Female I/FU:I Outcome PT Hospitalization - Bronchitis Initial or Prolonged Cerebrovascular Accident Required Chronic Obstructive Intervention to Pulmonary Disease Prevent Permanent Confusional State Impairment/Damage Extrapyramidal Disorder Feeling Abnormal Influenza Like Illness 24-Jun-2005 12:19 PM Page: 1837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nightmare Screaming Report Source Product Role Manufacturer Route Dose Duration Consumer Navane Capsules PS ORAL 4.00 MG TOTAL:DAILY:O RAL Nicotine SS Zyprexa SS ORAL 2.50 MG TOTAL:DAILY:O RAL Depakote SS ORAL ORAL Timoptic C Date:03/19/02ISR Number: 3886005-8Report Type:Expedited (15-DaCompany Report #FR_020200719 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Zyprexa-Oral Hospitalization - Phosphokinase Increased Health (Olanzapine) Initial or Prolonged Blood Pressure Decreased Professional (Olanzapine) PS 15 MG/DAY Fall Other Imovane C Haemoglobin Decreased Forlax (Macrogol) C Hepatocellular Damage Hypothermia Inflammation Leukopenia Lung Disorder Neutropenia Thrombocytopenia Date:03/19/02ISR Number: 3886091-5Report Type:Expedited (15-DaCompany Report #001-0945-M0200293 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thyroid Disorder Consumer Neurontin Initial or Prolonged Weight Increased (Gabapentin) PS Olanzapine SS 10 MG (5 MG, TWICE A DAY) Dicycloverine Hydrochloride C Folic Acid C Docusate Sodium Casanthranol C Levothyroxine C Lisinopril C Multivitamins With Minerals C Thiamine C Verapamil C Verapamil C Benzatropine Mesilate C Loxapine C Bisacodyl C Lorazepam C 24-Jun-2005 12:19 PM Page: 1838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/02ISR Number: 3885619-9Report Type:Direct Company Report #CTU 163738 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Zyprexa (Olanzepine) PS 2.5 QD Abnormal Paxil C Xanax C Valium C Date:03/20/02ISR Number: 3885803-4Report Type:Direct Company Report #CTU 163815 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Olanzapine Lilly PS Lilly ORAL 20 MG QD ORAL Intervention to Fluphenazine SS ORAL 5 MG QD ORAL Prevent Permanent Impairment/Damage Date:03/20/02ISR Number: 3886467-6Report Type:Direct Company Report #CTU 163856 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa 10mg PS ORAL 10MG HS ORAL Initial or Prolonged Phosphokinase Increased Fall Date:03/25/02ISR Number: 3888075-XReport Type:Direct Company Report #CTU 164098 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Zyprexa PS Initial or Prolonged Date:03/25/02ISR Number: 3888077-3Report Type:Direct Company Report #CTU 164099 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Olanzepine PS Initial or Prolonged Buspar SS Depakote C Date:03/26/02ISR Number: 3888897-5Report Type:Direct Company Report #CTU 164197 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Zyprexa 2.5 Mg PS ORAL 2.5MG DAILY Syndrome ORAL Date:03/26/02ISR Number: 3888938-5Report Type:Direct Company Report #CTU 164192 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Fortovase Increased -Saquinavir- 200mg Blood Triglycerides Roche PS Roche ORAL 1200MG TID Increased ORAL 24-Jun-2005 12:19 PM Page: 1839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zypreza-Olanzapine- 5mg Lilly SS Lilly ORAL 15MG QHS ORAL Date:03/27/02ISR Number: 3890262-1Report Type:Direct Company Report #CTU 164250 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Zyprexa PS ORAL 1 MON Required Intervention to Prevent Permanent Impairment/Damage Date:03/27/02ISR Number: 3890419-XReport Type:Direct Company Report #CTU 164344 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Zyprexa 10 Mg > 40 Mg> 10mg> Dc 2/26/02 PS 10MG -> 40 MG -> 10MG -> DC 2/26/02 ABOVE Haldol C Date:03/27/02ISR Number: 3891044-7Report Type:Expedited (15-DaCompany Report #PHRM2002FR00980 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Retinal Detachment Foreign Tegretol Retinal Haemorrhage Health (Carbamazepine) Visual Acuity Reduced Professional Tablet PS ORAL 1 DF, BID, Other ORAL Teralithe(Lithium Carbonate) Slow Release Tablet SS ORAL 400 MG, BID, ORAL Zyprexa (Olanzapine) Tablet SS ORAL 27.5 MG/DAY, ORAL Oral Contraceptive Nos C Date:03/28/02ISR Number: 3890768-5Report Type:Direct Company Report #CTU 164356 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Olanzepine Dose Initial or Prolonged Unknown PS Methadone C Clonazepam C Date:03/28/02ISR Number: 3891876-5Report Type:Expedited (15-DaCompany Report #02P-163-0189748-00 Age:44 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased 24-Jun-2005 12:19 PM Page: 1840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram Abnormal Myocardial Ischaemia Report Source Product Role Manufacturer Route Dose Duration Overdose Foreign Depakote Tablets Somnolence Health (Divalproex Sodium) Professional (Divalproex Sodium) PS ORAL ORAL Other Naproxen Sodium SS ORAL ORAL Olanzapine SS ORAL ORAL Date:03/28/02ISR Number: 3891966-7Report Type:Expedited (15-DaCompany Report #US_010871741 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Headache Health (Olanzapine) Insomnia Professional (Olanzapine) PS 20 MG/DAY Irritability Company Risperdal Poisoning Deliberate Representative (Risperidone) C Hiberna (Promethazine Hydrochloride) C Depas (Etizolam) C Silece (Flunitrazepam) C Date:03/28/02ISR Number: 3891968-0Report Type:Expedited (15-DaCompany Report #US_020282179 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Contusion Foreign Olanzapine-Oral Life-Threatening Extrapyramidal Disorder Study (Olanzapine) PS 10 MG DAY Fall Health Fluphenazine C Haematemesis Professional Periactin Subdural Haematoma (Cyprohepatidine Hydrochloride) C Emilace (Nemonapride) C Serenace (Haloperidol) C Vegetamin B C Laxoberon (Sodium Picosulfate) C Pursennid (Senna Leaf) C Akineton (Biperiden Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Hirnamin (Levomepromazine) C Pyrethia (Promethazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/02ISR Number: 3892107-2Report Type:Direct Company Report #CTU 164431 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Olanzapine PS ORAL ORAL Life-Threatening Neoplasm Malignant Hospitalization - Skin Cancer Initial or Prolonged Date:03/29/02ISR Number: 3892650-6Report Type:Direct Company Report #CTU 164460 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Zyprexa-Oral Hospitalization - (Olanzapine)(Olanzap Initial or Prolonged ine) PS 5MG/DAY Required Aricept SS 10MG Intervention to Prevent Permanent Impairment/Damage Date:03/29/02ISR Number: 3892722-6Report Type:Expedited (15-DaCompany Report #A206561 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Ziprasidone Po PS ORAL ORAL Intervention to Weight Increased Professional Zyprexa SS Prevent Permanent Company Impairment/Damage Representative Date:03/29/02ISR Number: 3892725-1Report Type:Expedited (15-DaCompany Report #2002AP00620 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Literature Quetiapine PS ORAL 100 MG DAILY Intervention to Convulsion Health PO 1 DAY Prevent Permanent Disorientation Professional Olanzapine SS ORAL 15 MG DAILY Impairment/Damage Drug Interaction PO Fall Benztropine C Tongue Biting Sertraline C Tremor Clonazepam C Date:04/01/02ISR Number: 3892812-8Report Type:Direct Company Report #CTU 164662 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Zyprexia-Oral Hospitalization - (Olanzapine) Initial or Prolonged (Olanzapine) PS ORAL 5 MG/DAY 6 MON Required Aricept SS 10 MG Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 1842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/02ISR Number: 3893727-1Report Type:Expedited (15-DaCompany Report #US96123673A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Polydipsia Professional (Olanzapine) (Olanzapine) PS 5 MG/1 DAY Risperidone C Paroxetine C Date:04/02/02ISR Number: 3893864-1Report Type:Expedited (15-DaCompany Report #US_020382922 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 250 MG/DAY Date:04/02/02ISR Number: 3893979-8Report Type:Expedited (15-DaCompany Report #US96124591A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 5 MG/ 1 DAY 2 WK Date:04/02/02ISR Number: 3893985-3Report Type:Expedited (15-DaCompany Report #USA020312606 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Catecholamines Health Zyprexa-Oral Initial or Prolonged Abnormal Professional (Olanzapine) Blood Pressure Increased (Olanzapine) PS Seroquel C Date:04/02/02ISR Number: 3893987-7Report Type:Expedited (15-DaCompany Report #US_020382878 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniocentesis Abnormal Health Zyprexa-Oral Initial or Prolonged Complications Of Maternal Professional (Olanzapine) Exposure To Therapeutic (Olanzapine) PS Drugs Laboratory Test Abnormal Maternal Drugs Affecting Foetus Premature Baby Ultrasound Scan Abnormal Date:04/02/02ISR Number: 3894081-1Report Type:Expedited (15-DaCompany Report #AU_020304858 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY 4 DAY Other Fluanxol 24-Jun-2005 12:19 PM Page: 1843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Flupentixole Dihydrochloride) C Date:04/02/02ISR Number: 3894116-6Report Type:Expedited (15-DaCompany Report #US_010872777 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Foreign Zyprexa (Olanzapine) PS 20 MG/DAY Other Cerebral Haemorrhage Health Lodipin(Zotepine) C Grand Mal Convulsion Professional Impromen(Bromperidol Mydriasis Company ) C Tachycardia Representative Luvox (Fluvoxamine Other Maleate) C Sennoside A C Selbex (Teprenone) C Bicamol(Biperidem Hydrochloride) C Vegetamin A C Date:04/02/02ISR Number: 3894167-1Report Type:Expedited (15-DaCompany Report #US_020281789 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine)(Olanzap Other Hepatic Steatosis Professional ine) PS 10 MG/DAY Hepatocellular Damage Company Levotomin Hyperuricaemia Representative (Levomepromazine Obesity Other Maleate) C Lendormin (Brotizolam) C Lipitor (Astorvastatin) C Actos (Pioglitazone) C Zyloric (Allopurinol) C Date:04/02/02ISR Number: 3894169-5Report Type:Expedited (15-DaCompany Report #US_020382388 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Dyspnoea Health (Olanzapine Neuroleptic Malignant Professional (Olanzapine) PS 250 MG/DAY Syndrome Company Rohypnol Overdose Representative (Flunitrazepam) C Pneumonia Rhabdomyolysis Date:04/02/02ISR Number: 3894171-3Report Type:Expedited (15-DaCompany Report #US_020383040 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Death Hallucination Foreign Hallucination, Auditory Health Insomnia Professional Overdose Company Representative 24-Jun-2005 12:19 PM Page: 1844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine)(Olanzap ine) PS 20 MG/DAY Quetiapine Fumarate C Silece (Flunitrazepam) C Chloramphenicol C Anafranil (Clomipramine Hydrochloride) C Diazepam C Date:04/02/02ISR Number: 3894175-0Report Type:Expedited (15-DaCompany Report #US_020382774 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Zyprexa-Oral Hospitalization - Phosphokinase Increased Health (Olanzapine) Initial or Prolonged Diabetic Coma Professional (Olanzapine) PS 50 MG/DAY Other Dialysis Other Prothiaden Hyperglycaemia (Dosulepin) C Malaise Levotomin C Nausea Rohypnol Neuroleptic Malignant (Flunitrazepam) C Syndrome Limas (Lithium Pyrexia Carbonate) C Rhabdomyolysis Halcion (Triazolam) C Shock Thirst Date:04/02/02ISR Number: 3894191-9Report Type:Expedited (15-DaCompany Report #US_020180121 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Weight Increased Study (Olanzaine) PS 12 MG/2 DAY Health Fluoxetine-Oral Professional (Fluoxetine) Other (Fluoxetine Hydrochlor SS 50 MG AT BEDTIME Lorazepam C Date:04/02/02ISR Number: 3894196-8Report Type:Expedited (15-DaCompany Report #DE_020308313 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Zyprexa-Oral Initial or Prolonged Hepatitis Health (Olanzapine) Jaundice Professional (Olanzapine) PS 10 MG/DAY Other Novodigal (Digoxin) C Tavor (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/02ISR Number: 3894251-2Report Type:Expedited (15-DaCompany Report #US_020282163 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Foreign Olanzapine-Oral Initial or Prolonged Increased Study (Olanzapine) PS 20 MG/DAY Hallucination, Auditory Health Serenace Persecutory Delusion Professional (Haloperidol) C Other Chlorpromazine C Date:04/02/02ISR Number: 3894732-1Report Type:Expedited (15-DaCompany Report #US_020383050 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Zyprexa-Oral Hepatic Function Abnormal Health (Olanzapine) Increased Appetite Professional (Olanzapine) PS 20 MG/DAY Obesity Company Contomin Representative 9chlorpromazine Other Hydrochloride) C Linton (Haloperidol) C Seroquel C Date:04/02/02ISR Number: 3894860-0Report Type:Expedited (15-DaCompany Report #US_020281566 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypervolaemia Foreign Zyprexa-Oral Life-Threatening Hypotonia Health (Olanzapine) Other Lung Disorder Professional (Olanzapine) PS 20 MG/DAY Respiratory Arrest Company Akineton (Biperidem Snoring Representative Hydrochloride) C Somnolence Other Etizolam C Sudden Death Tegretol Tongue Spasm (Carbamazepine) C Weight Increased Risperdal (Risperidone) C Ethyl Loflazepate C Neoperidol C Date:04/02/02ISR Number: 3896612-4Report Type:Periodic Company Report #US_010769680 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atelectasis Consumer Zyprexa (Olanzapine) PS 5 MG/DAY 6 WK Initial or Prolonged Chest Wall Pain Prozac (Fluoxetine Oedema Peripheral Hydrochloride) SS 80 MG/DAY 13 YR Hydrochlorothiazide With Triamterene C Date:04/02/02ISR Number: 3896621-5Report Type:Periodic Company Report #US_010666987 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Olanzapine PS 6 MG DAY Initial or Prolonged Health Fluoxetine Professional (Fluoxetine Hydrochloride) SS 25 MG DAY 24-Jun-2005 12:19 PM Page: 1846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maxalt (Ritatriptan Benzoate C Tylenol (Paracetamol) C Date:04/03/02ISR Number: 3894899-5Report Type:Expedited (15-DaCompany Report #USA020312345 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Consumer Zyprexa-Oral Hospitalization - (Olanzapine) Initial or Prolonged (Olanzapine) PS 7.5 MG/DAY Date:04/03/02ISR Number: 3894901-0Report Type:Expedited (15-DaCompany Report #USA020312412 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Zyprexa-Oral Professional (Olanzapine) PS 5 MG/DAY 1 WK Company Representative Date:04/03/02ISR Number: 3894903-4Report Type:Expedited (15-DaCompany Report #USA020312459 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Date:04/03/02ISR Number: 3895075-2Report Type:Expedited (15-DaCompany Report #US_020181147 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polymyositis Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/DAY Date:04/03/02ISR Number: 3895305-7Report Type:Expedited (15-DaCompany Report #US_020382645 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Olanzapine-Oral Cardiac Arrest Study (Olanzapine) PS 5 MG DAY Dysphagia Health Clofekton Extrasystoles Professional (Clocapramine Faecal Incontinence Other Hydrochloride) C Heart Rate Increased Neuleptil Injury Asphyxiation (Periciazine) C Pulse Absent Hirnamin Respiratory Arrest (Levomepromazine) C Wheezing Akineton (Biperiden Hydrochloride) C Magnesium Oxide C Effortil (Etilefrine 24-Jun-2005 12:19 PM Page: 1847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Hiberna (Promethazine Hydrochloride) C Benzalin (Nitrazepam) C Gaster (Famotidine) C Pursennid (Senna Leaf) C Dogmatyl (Sulpiride) C Date:04/03/02ISR Number: 3895306-9Report Type:Expedited (15-DaCompany Report #DE_020308221 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Health (Olanzapine) Respiratory Rate Professional (Olanzapine) PS 1000 MG Decreased Other Suicide Attempt Date:04/03/02ISR Number: 3895492-0Report Type:Expedited (15-DaCompany Report #US_020281820 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Aggression Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS 5 MG/DAY Increased Appetite Company Serenace Psychiatric Symptom Representative (Haloperidol) C Other Apamin (Periciazine) C Hibernia (Promethazine Hydrochloride) C Benzalin (Nitrazepam) C Halcion (Triazolam) C Date:04/03/02ISR Number: 3895493-2Report Type:Expedited (15-DaCompany Report #US_020382678 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Hospitalization - Pneumonia Health (Olanzapine) Initial or Prolonged Pneumonia Aspiration Professional (Olanzapine) PS 10 MG/DAY Other Somnolence Company Firstcin (Cefozopran Representative Hydrochloride) C Other Excegran (Zonisamide) C Midodrine Hydrochloride C Silece (Flunitrazepam) C Risperidone C Depakene (Valproate Sodium) C Emilace (Nemonapride) C 24-Jun-2005 12:19 PM Page: 1848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/02ISR Number: 3895494-4Report Type:Expedited (15-DaCompany Report #US_020382801 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Henoch-Schonlein Purpura Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG/DAY Professional Haloperidol C Company Etizolam C Representative Mianserin Other Hydrochloride C Flunitrazepam C Zopiclone C Date:04/03/02ISR Number: 3895618-9Report Type:Expedited (15-DaCompany Report #FR_011200434 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Depo Provera (Medroxyprogesterone Acetate) C Date:04/03/02ISR Number: 3895620-7Report Type:Expedited (15-DaCompany Report #EWC020129740 Age:4 MON Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Induced Foreign Zyprexa-Oral Initial or Prolonged Maternal Drugs Affecting Health (Olanzapine) Congenital Anomaly Foetus Professional (Olanzapine) PS Pregnancy Company Frontin (Alprazolam) C Spina Bifida Representative Tegretol Other (Carbamazepine) C Date:04/03/02ISR Number: 3895623-2Report Type:Expedited (15-DaCompany Report #CA_020104713 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Muscle Necrosis Health (Olanzapine) Pain Professional (Olanzapine) PS 20 MG DAY Polymyositis Other Clonazepam C Treatment Noncompliance Sertraline C Date:04/03/02ISR Number: 3895626-8Report Type:Expedited (15-DaCompany Report #DE_020308190 Age:56 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anuria Initial or Prolonged Asthenia Back Pain Blood Creatinine Increased Blood Urea Increased Chromaturia Loss Of Consciousness Pyrexia 24-Jun-2005 12:19 PM Page: 1849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhabdomyolysis Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/2 DAY Other Xanef (Enalapril Maleate) C Dytide H C Norvasc (Amlodipine Besilate) C Diazepam C Tavor (Lorazepam) C Akineton (Biperiden Hydrochloride) C Ciatyl-Z (Acuphase (Zuclopenthixol Acetate) C Date:04/03/02ISR Number: 3895628-1Report Type:Expedited (15-DaCompany Report #EWC020330232 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oral Initial or Prolonged Prolonged Health (Olanzapine) Medication Error Professional (Olanzapine) PS 15 MG/DAY Overdose Company Trittico (Trazodone Sedation Representative Hydrochloride) C Suicide Attempt Other Date:04/03/02ISR Number: 3895957-1Report Type:Expedited (15-DaCompany Report #USA020312464 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Consumer Zyprexa-Oral (Olanzapine) PS 2.5 MG/2 DAY Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Date:04/03/02ISR Number: 3895958-3Report Type:Expedited (15-DaCompany Report #USA020211152 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa-Oral Initial or Prolonged Blood Creatine Professional (Olanzapine) PS 30 MG/DAY 21 MON Phosphokinase Increased Company Chlorpromazine C Condition Aggravated Representative Prilosec C Depressed Level Of Stool Softener Consciousness (Docusate Sodium) C Myoglobin Blood Increased Sinusitis 24-Jun-2005 12:19 PM Page: 1850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/02ISR Number: 3896915-3Report Type:Expedited (15-DaCompany Report #2002AP00620 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Literature Quetiapine PS ORAL 100 MG DAILY Intervention to Convulsion Health PO 1 DAY Prevent Permanent Disorientation Professional Olanzapine SS ORAL 15 MG DAILY Impairment/Damage Drug Interaction PO Fall Benztropine C Memory Impairment Sertraline C Clonazepam C Date:04/05/02ISR Number: 3898215-4Report Type:Direct Company Report #CTU 165143 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Olanzapine PS SEE #5 (LAST Increased DOSAGES PM MEDS DAY BEFORE HE WAS FOUND) Risperdol SS SEE #5 (LAST DOSAGES PM MEDS DAY BEFORE HE WAS FOUND) Date:04/09/02ISR Number: 3897871-4Report Type:Expedited (15-DaCompany Report #02P-114-0190600-00 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Tranxene Initial or Prolonged Electrocardiogram Qt Health (Clorazepate Prolonged Professional Dipotassium) Hypotension Other (Clorazepate Somnolence Dipotassium) PS ORAL 50 MG, 1 IN 1 D, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 D, PER ORAL Date:04/09/02ISR Number: 3897934-3Report Type:Expedited (15-DaCompany Report #2002AP00556 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Flatulence Health PO Prevent Permanent Gastrointestinal Motility Professional Seroquel SS ORAL 150 MG DAILY Impairment/Damage Disorder Other PO Intestinal Dilatation Seroquel SS ORAL 75 MG DAILY Nausea PO Somnolence Risperdal SS ORAL 3 MG DAILY PO Vomiting Tasmolin SS ORAL 3 MG DAILY PO Zyprexa SS ORAL 10 MG DAILY PO Levotomin SS ORAL 20 MG DAILY PO Depas C Sennoside C Pantosin C 24-Jun-2005 12:19 PM Page: 1851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report No Match C Gascon C Magnesium Oxide C Date:04/09/02ISR Number: 3898821-7Report Type:Direct Company Report #CTU 165354 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Zyprexa PS ORAL 2.5 -> 3.0 MG Abnormal PO HS X 1, + Overdose HS Vomiting Methodone C Zithromax C Multivitamin C Acetaminophen C Robitussin C Nicotine Gum C Reglan/Activated Charcoal C Prolixin C Vistaril C Date:04/10/02ISR Number: 3899547-6Report Type:Direct Company Report #CTU 165461 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Olanzapine PS SEE #5 (LAST Increased DOSAGES PRN MEDS DAY BEFORE HE WAS FOUND) Risperdol SS SEE #5 (LAST DOSAGES PRN MEDS DAY BEFORE HE WAS FOUND) Date:04/11/02ISR Number: 3897446-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Risperdal PS ORAL 14 DAY Schizophrenia Chlorpromazine Hydrochloride SS ORAL 916 DAY Quetiapine Fumarate SS ORAL 237 DAY Trihexyphenidyl Hydrochloride SS ORAL 916 DAY Flunitrazepam SS ORAL 916 DAY Teprenone SS ORAL 185 DAY Biperiden Hydrochloride SS ORAL 916 DAY Olanzapine SS ORAL 41 DAY Levomepromazine Maleate SS ORAL 721 DAY Diazepam SS ORAL 14 DAY Promethazine SS ORAL 83 DAY Nitrazepam SS ORAL 47 DAY Lorazepam SS ORAL 376 DAY 24-Jun-2005 12:19 PM Page: 1852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report L-Cysteine Ethylester Hydrocholoride SS ORAL 14 DAY Mosapramine SS ORAL 23 DAY Etizolam SS ORAL 93 DAY Impromen SS ORAL 501 DAY Risperdal C ORAL 28 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 9 DAY Risperdal C ORAL 306 DAY Risperdal C ORAL 28 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 14 DAY Levomepromazine Maleate C ORAL Flunitrazepam C ORAL Teprenone C ORAL Biperiden Hydrochloride C ORAL Trihexyphenidyl Hydrochloride C ORAL Olanzapine C ORAL Quetiapine Fumarate C ORAL Chlorpromazine Hydrochloride C ORAL Risperdal C ORAL 14 DAY Risperdal C ORAL 49 DAY Risperdal C ORAL 35 DAY Risperdal C ORAL 126 DAY Risperdal C ORAL 63 DAY Risperdal C ORAL 174 DAY Risperdal C ORAL Date:04/11/02ISR Number: 3899349-0Report Type:Expedited (15-DaCompany Report #EWC020330424 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa-Oral Initial or Prolonged Drug Interaction Health (Olanzapine) PS 10 MG/DAY Electrocardiogram Qt Professional Tranxene Prolonged Other (Clorazepate Hypotension Dipotassium) C Somnolence Date:04/11/02ISR Number: 3899351-9Report Type:Expedited (15-DaCompany Report #DE_020308343 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Foreign Zyprexa Initial or Prolonged Repolarisation Health (Olanzapine) PS ORAL 10 MG/ 1 IN Abnormality Professional THE EVENING Other Vitamin B12 C 24-Jun-2005 12:19 PM Page: 1853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/02ISR Number: 3899354-4Report Type:Expedited (15-DaCompany Report #GBS020310443 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Olanzapine PS ORAL 10 MG/DAY Depression Health Haloperidol C Left Ventricular Failure Professional Lustral (Sertraline Other Hydrochloride) C Procyclidine C Date:04/11/02ISR Number: 3899355-6Report Type:Expedited (15-DaCompany Report #EWC020330452 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Post Procedural Foreign Zyprexa Disability Complication Health (Olanzapine) PS 7.5 MG/DAY Pulmonary Embolism Professional Fevarin Company (Fluvoxamine Representative Maleate) C Other Xanax (Alprazolam) C Date:04/11/02ISR Number: 3899357-XReport Type:Expedited (15-DaCompany Report #EWC020330438 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Zyprexa Hospitalization - Vomiting Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Professional Praxiten (Oxazepam) C Company Representative Other Date:04/11/02ISR Number: 3899360-XReport Type:Expedited (15-DaCompany Report #EWC020330407 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Olanzapine PS 30 MG/DAY Decreased Health Professional Other Date:04/11/02ISR Number: 3899410-0Report Type:Expedited (15-DaCompany Report #CA_020204815 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Biopsy Bone Marrow Foreign Olanzapine-Oral Hospitalization - Abnormal Study (Olanzapine) PS 20 MG Initial or Prolonged Body Temperature Health Hydrochlorothiazide C Other Increased Professional Coversyl Pancytopenia Other (Perindopril) C Salbutamol C 24-Jun-2005 12:19 PM Page: 1854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/02ISR Number: 3899427-6Report Type:Expedited (15-DaCompany Report #US_020382678 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Hospitalization - Dysphagia Health (Olanzapine) Initial or Prolonged General Physical Health Professional (Olanzapine) PS 10 MG/DAY Other Deterioration Company Firstcin (Cefozopran Incontinence Representative Hydrochloride) C Injury Asphyxiation Other Midodrine Malnutrition Hydrochloride C Otorrhoea Silece(Flunitrazepam Pneumonia ) C Pneumonia Aspiration Risperidone C Pyrexia Depakene(Valproate Somnolence Sodium) C Serenace(Haloperidol ) C Akineton(Biperiden Hydrochloride) C Ubretid (Distigmine Bromide) C Impromen(Bromperidol ) C Lactulose C Cravit(Levofloxacin) C Glycerin C Date:04/11/02ISR Number: 3899429-XReport Type:Expedited (15-DaCompany Report #GBS010909482 Age:0 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Caesarean Section Foreign Zyprexa (Olanzapine) PS Complications Of Maternal Health Sertraline C Exposure To Therapeutic Professional Drugs Company Congenital Hypothyroidism Representative Maternal Drugs Affecting Other Foetus Pregnancy Date:04/11/02ISR Number: 3899431-8Report Type:Expedited (15-DaCompany Report #EWC020330232 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oral Initial or Prolonged Prolonged Health (Olanzapine) Overdose Professional (Olanzapine) PS 15 MG/DAY Sedation Company Trittico (Trazodone Suicide Attempt Representative Hydrochloride) C Other Date:04/11/02ISR Number: 3899432-XReport Type:Expedited (15-DaCompany Report #EWC020230051 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Renal Failure Foreign Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 1855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/DAY Haloperidol C Date:04/11/02ISR Number: 3899433-1Report Type:Expedited (15-DaCompany Report #DE_020308313 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Zypexa-Oral(Olanzapi Initial or Prolonged Health ne)(Olanzapine) PS 10 MG/DAY Professional Novodigal(Digoxin) C Other Tavor(Lorazepam) C Date:04/11/02ISR Number: 3899442-2Report Type:Expedited (15-DaCompany Report #USA020312979 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Zyprexa-Oral Initial or Prolonged Mania Professional (Olanzapine) (Olanzapine) PS 30 MG/DAY Eskalith Cr (Lithium Carbonate) C Date:04/11/02ISR Number: 3899443-4Report Type:Expedited (15-DaCompany Report #US_020383011 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Health Zyprexa-Oral Transient Ischaemic Professional (Olanzapine) Attack Company (Olanzapine) PS 5 MG/DAY Representative Sinemet C Promazine C Date:04/11/02ISR Number: 3899445-8Report Type:Expedited (15-DaCompany Report #USA020313015 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:04/11/02ISR Number: 3899695-0Report Type:Expedited (15-DaCompany Report #USA020210909 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa-Oral Intentional Misuse Professional (Olanzapine) Company (Olanzapine) PS 40 MG/DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine 24-Jun-2005 12:19 PM Page: 1856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS 20 MG/DAY Date:04/11/02ISR Number: 3899696-2Report Type:Expedited (15-DaCompany Report #USA020110589 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Consumer Zyprexa-Oral Apathy Health (Olanzapine) Blood Urea Increased Professional (Olanzapine) PS 2.5 MG/2 DAY Difficulty In Walking Aricept (Donepezil Gastric Ulcer Haemorrhage Hydrochloride) C Haematocrit Decreased Lorazepam C Haemoglobin Decreased Vioxx (Rofecoxib) C Listless Prilosec Pyrexia (Omeprazole) C Red Blood Cell Count Decreased Urinary Tract Infection Weight Decreased White Blood Cell Count Increased Date:04/12/02ISR Number: 3900144-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal Fall Health (Risperidone) PS SEE IMAGE Schizophrenia Professional Impromen (Unspecified) (Bromperidol) SS VARYING DOSES FROM 6 TO 24 MG DAILY Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS VARYING DOSES FROM 25 TO 300 MG DAILY Biperiden Hydrochloride (Biperiden Hydrochloride) SS VARYING DOSES FROM 3 TO 6 MG DAILY Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL VARYING DOSE FROM 5 MG TO 50 MG DAILY, PO Olanzapine (Olanzapine) SS ORAL MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS VARYING DOSES FROM 50 TO 600 MG DAILY 24-Jun-2005 12:19 PM Page: 1857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Lorazepam) SS VARYING DOSES FROM 0.5 WHEN NECESSARY TO 3 MG DAILY Promethazine (Promethazine) SS ORAL MG, DAILY, ORAL Diazepam (Diazepam) SS ORAL MG, PRN, ORAL Nitrazepam (Nitrazepam) SS ORAL MG, DAILY, ORAL L-Cysteine Ethylester Hydrocholoride (L-Cysteine Ethylester, SS ORAL MG, DAILY, ORAL Flunitrazepam (Flunitrazepam) SS ORAL VARYING DOSE FROM 1 MG TO 4 MG DAILY, PO Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS VARYING DOSES FROM 4 TO 12 MG DAILY Teprenone (Teprenone) C VARYING DOSES FROM 150 TO 300 MG DAILY Etizolam (Etizolam) C ORAL MG, DAILY, ORAL Mosapramine (Mosapramine) C VARYING DOSES FROM 50 TO 150 MG DAILY Date:04/16/02ISR Number: 3900371-6Report Type:Direct Company Report #CTU 165753 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Zyprexa PS 5MG @ NOON Initial or Prolonged Hyperhidrosis AND HS Rhabdomyolysis OUTPATIENT Trilafon C Haldol C Sorata C Date:04/16/02ISR Number: 3900746-5Report Type:Direct Company Report #CTU 165839 Age:23 YR Gender:Male I/FU:I Outcome PT Death Clumsiness Confusional State Encephalitis Haemodialysis 24-Jun-2005 12:19 PM Page: 1858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Ischaemia Metabolic Disorder Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Olanzapine 10 Mg Nausea Lilly PS Lilly ORAL 10MG HS PO Petechiae Trileptal C Pyrexia Norvasc C Renal Failure Acute Nexium C Renal Tubular Necrosis Lithium C Respiratory Rate Atenolol C Increased Nystatin C Rhabdomyolysis Vomiting Date:04/16/02ISR Number: 3901076-8Report Type:Direct Company Report #CTU 165800 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Zyprexa PS ORAL 2.5 -> 3.0 MG Abnormal PO X 1 AND HS Overdose Reglan C Vomiting Activated Charcoal C Zyprexa C Methodone C Zithromax C Multivitamin C Acetaminophen C Robitussin C Nicotine Gum C Prolixin Hcl C Vistaril C Date:04/16/02ISR Number: 3902374-4Report Type:Expedited (15-DaCompany Report #FLUV00302000769 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Luvox 25 Phosphatase Increased Health (Fluvoxamine Blood Pressure Systolic Professional Maleate) PS ORAL SEE IMAGE Increased Other Lodopin (Zotepine) SS ORAL 150 MG DAILY Convulsion PO Drug Interaction Zyprexa (Olanzapine) SS ORAL SEE IMAGE Electroencephalogram Impromen Abnormal (Bromperidol) SS ORAL 18 MG DAILY Fall PO Heart Rate Increased Sennoside Mouth Haemorrhage (Sennoside) C Musculoskeletal Stiffness Selbex (Teprenone) C Mydriasis Bicamol (Biperiden Schizophrenia Hydrochloride) C Scratch Vegetamin A () C Somnolence 24-Jun-2005 12:19 PM Page: 1859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/02ISR Number: 3902058-2Report Type:Expedited (15-DaCompany Report #EWC020430501 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Iliac Vein Thrombosis Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Date:04/17/02ISR Number: 3902063-6Report Type:Expedited (15-DaCompany Report #FR_020400835 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytolytic Hepatitis Foreign Zyprexa-Oral Oedema Health (Olanzapine) Oedema Peripheral Professional (Olanzapine) PS 7.5 MG/DAY Pain Other Lysanxia (Prazepam) C Subcutaneous Nodule Urticaria Date:04/17/02ISR Number: 3902069-7Report Type:Expedited (15-DaCompany Report #US_020483183 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 25 MG/DAY Company Norvasc (Amlodipine Representative Besilate) C Other Novarok (Imidapril Hydrochloride) C Shiomarin (Latamoxef) Mellitus C Date:04/17/02ISR Number: 3902089-2Report Type:Expedited (15-DaCompany Report #US_020483405 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enterocolitis Foreign Olanzapine-Oral Initial or Prolonged Study (Olanzapine) PS 15 MG DAY Health Wintermin Professional (Chlorpromazine Other Hydrochloride) C Diazepam C Artane (Trihexyphenidyl Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Pursennid (Senna Leaf) C Magnesium Oxide C Biofermin R (Streptococcus Faecalis) C Simvastatin C 24-Jun-2005 12:19 PM Page: 1860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/02ISR Number: 3902090-9Report Type:Expedited (15-DaCompany Report #DE_020408396 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Foreign Zprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Aequamen (Vethahistine Mesilate) C Date:04/17/02ISR Number: 3902091-0Report Type:Expedited (15-DaCompany Report #EWC020430507 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Selo-Zok (Metroprolol Succinate) C Zestril (Lisinopril) C Diural (Furosemide) C Marevan (Warfarin Sodium) C Digitoxin C Date:04/17/02ISR Number: 3902124-1Report Type:Expedited (15-DaCompany Report #US_020483211 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Anaemia Professional Olanzapine) PS 5 MG/DAY Aspartate Company Risperdal Aminotransferase Representative (Risperidone) C Increased Other Akineton (Biperiden Hepatic Function Abnormal Hydrochloride) C Halcion(Triazolam) C Depas(Etizolam) C Lendormin(Brotizolam ) C Date:04/17/02ISR Number: 3902125-3Report Type:Expedited (15-DaCompany Report #US_020483352 Age:69 YR Gender:Female I/FU:I Outcome PT Hospitalization - Amnesia Initial or Prolonged Asthenia Other Blood Creatine Phosphokinase Increased Brain Oedema C-Reactive Protein Increased Cerebral Haemorrhage Disorientation Dysstasia Fall Headache 24-Jun-2005 12:19 PM Page: 1861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Urinary Incontinence White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Zyprexa-Oral Health (Olanzapine)(Olanzap Professional ine) PS 5 MG/DAY Company Depromel Representative (Fluvoxamine) C Other Doral(Quazepam) C Date:04/17/02ISR Number: 3902201-5Report Type:Expedited (15-DaCompany Report #2002AP00855 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Literature Quetiapine PS 100 MG TID Intervention to Inadequate Control Health Olanzapine SS 10 MG Prevent Permanent Weight Increased Professional Sertraline C Impairment/Damage Haloperidol Decanoate C Fluoxetine C Venlafaxine C Date:04/17/02ISR Number: 3902243-XReport Type:Expedited (15-DaCompany Report #USA020110526 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Zyprexa-Oral Initial or Prolonged Chest Pain Health (Olanzapine) Decreased Activity Professional (Olanzapine) PS 1.25 MG/AT Platelet Count Abnormal BEDTIME Multivitamin C Date:04/17/02ISR Number: 3902399-9Report Type:Expedited (15-DaCompany Report #DE_000802838 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Zyprexa-Oral Initial or Prolonged Depressed Level Of Literature (Olanzapine) Disability Consciousness Health (Olanzapine) PS 20 MG/DAY Diabetic Hyperosmolar Professional Quilonum - Slow Coma Other Release (Lithium Hyperglycaemia Carbonate) C Lethargy Anafranil Malaise (Clomipramine Mental Disorder Due To A Hydrochloride) C General Medical Condition Paraesthesia Renal Failure Acute Rhabdomyolysis Thirst Vision Blurred 24-Jun-2005 12:19 PM Page: 1862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/02ISR Number: 3902457-9Report Type:Expedited (15-DaCompany Report #US_020281705 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Zyprexa-Oral Increased (Olanzapine) Hypertriglyceridaemia (Olanzapine) PS 6 MON Testis Cancer Weight Increased Date:04/17/02ISR Number: 3902460-9Report Type:Expedited (15-DaCompany Report #USA020413469 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa-Oral Initial or Prolonged Disorientation Professional (Olanzapine) Dizziness Company (Olanzapine) PS 10 MG/DAY Miosis Representative Paxil (Paroxetine Muscle Spasms Hydrochloride) C Date:04/17/02ISR Number: 3902462-2Report Type:Expedited (15-DaCompany Report #US_020383112 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Literature Olanzapine-Oral Confusional State Health (Olanzapine) PS 15 MG/DAY Convulsion Professional Benztropine C Disorientation Sertraline C Drug Interaction Clonazepam C Fall Quetiapine C Speech Disorder Tongue Biting Tremor Date:04/17/02ISR Number: 3902467-1Report Type:Expedited (15-DaCompany Report #USA020313128 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Consumer Zyprexa-Oral Dyspepsia (Olanzapine) Epistaxis (Olanzapine) PS 5 MG/DAY Lethargy Pyrexia Syncope Date:04/17/02ISR Number: 3902491-9Report Type:Expedited (15-DaCompany Report #US_020382774 Age:39 YR Gender:Male I/FU:F Outcome PT Life-Threatening Apallic Syndrome Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Diabetic Hyperglycaemic Coma Dialysis Disseminated Intravascular Coagulation Hyperhidrosis 24-Jun-2005 12:19 PM Page: 1863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myoglobinuria Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Polydipsia Foreign Zyprexa-Oral Pyrexia Health (Olanzapine) Shock Professional (Olanzapine) PS 50 MG/DAY Tachycardia Company Prothiaden Tachypnoea Representative (Dosulepin) C Water Intoxication Other Levotomin Weight Increased (Levomepromazine White Blood Cell Count Maleate) C Increased Rohypnol (Flunitrazepam) C Limas (Lithium Carbonate) C Halcion(Triazolam) C , C Date:04/17/02ISR Number: 3902515-9Report Type:Expedited (15-DaCompany Report #USA020313247 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa-Oral Other Neuroleptic Malignant Professional (Olanzapine) Syndrome Company (Olanzapine) PS 40 MG/DAY Representative Trileptal (Oxcarbepine) C Lithium C Date:04/17/02ISR Number: 3902518-4Report Type:Expedited (15-DaCompany Report #USA020211713 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Zyprexa-Oral Initial or Prolonged Mania Professional (Olanzapine) Company (Olanzapine) PS Representative Geodon (Ziprasidone Hydrochloride) C Seroquel C Date:04/17/02ISR Number: 3902527-5Report Type:Expedited (15-DaCompany Report #US_020483209 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Literature Zyprexa-Oral Initial or Prolonged Coma Health (Olanzapine) Overdose Professional (Olanzapine) PS Tegretol (Carbamazepine) C Date:04/17/02ISR Number: 3902529-9Report Type:Expedited (15-DaCompany Report #USA020110440 Age:89 YR Gender:Female I/FU:I Outcome PT Life-Threatening Atrioventricular Block Hospitalization - Second Degree Initial or Prolonged Blood Glucose Increased 24-Jun-2005 12:19 PM Page: 1864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urea Increased Conduction Disorder Creatinine Renal Report Source Product Role Manufacturer Route Dose Duration Clearance Decreased Health Zyprexa-Oral Myocardial Ischaemia Professional (Olanzapine) Pco2 Decreased (Olanzapine) PS 5 MG/DAY Syncope Aricept (Donepezil Torsade De Pointes Hydrochloride) C Date:04/17/02ISR Number: 3902833-4Report Type:Expedited (15-DaCompany Report #DE_020107904 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa-Oral First Degree Health (Olanzapine) Bradycardia Professional (Olanzapine) PS 10 MG/DAY Electrocardiogram Qt Other Corrected Interval Shortened Date:04/17/02ISR Number: 3902836-XReport Type:Expedited (15-DaCompany Report #CA_020204815 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Biopsy Bone Marrow Foreign Olanzapine-Oral Hospitalization - Abnormal Study (Olanzapine) PS 20 MG Initial or Prolonged Blood Prolactin Increased Health Hydrochlorothiazide C Other Blood Triglycerides Professional Conversyl Increased Other (Perindopril) C Blood Urine Present Salbutamol C Body Temperature Increased Fatigue Infection Neutropenia Pancytopenia Protein Urine Renal Impairment Date:04/17/02ISR Number: 3902839-5Report Type:Expedited (15-DaCompany Report #EWC000506767 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa (Olanzapine) PS 5MG/DAY Initial or Prolonged Caesarean Section Health Complications Of Maternal Professional Exposure To Therapeutic Other Drugs Eclampsia Postpartum Disorder Pregnancy Schizophrenia 24-Jun-2005 12:19 PM Page: 1865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/02ISR Number: 3902841-3Report Type:Expedited (15-DaCompany Report #DE_020208110 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Zyprexa-Oral Initial or Prolonged Hearing Impaired Health (Olanzapine) Pyrexia Professional (Olanzapine) PS 5 MG/DAY Vasculitis Other Cipramil (Citalopram Viral Infection Hydrobromide) C Weight Decreased Weight Increased Date:04/17/02ISR Number: 3902846-2Report Type:Expedited (15-DaCompany Report #EWC020230012 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apgar Score Low Foreign Olanzapine-Oral Maternal Drugs Affecting Health (Olanzapine) PS Foetus Professional Cipramil (Citalopram Neonatal Disorder Company Hydrobromide) C Respiratory Disorder Representative Stelazine(Trifluoper Other azine Hydrochloride) C Date:04/17/02ISR Number: 3903040-1Report Type:Expedited (15-DaCompany Report #2002101362US Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Medrol Grand Mal Convulsion Professional (Methylprednisolone) Tablet PS ORAL ORAL 1 DAY Zyprexa (Olanzapine) SS Lithium SS Propranolol SS Levothyroxine SS Date:04/18/02ISR Number: 3902919-4Report Type:Expedited (15-DaCompany Report #A207676 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Ziprasidone Po PS ORAL 40.00 MG Hospitalization - Electrocardiogram Health TOTAL:DAILY:O Initial or Prolonged Abnormal Professional RAL Insomnia Olanzapine Po SS ORAL ORAL Loss Of Consciousness Fluoxetine SS ORAL ORAL Pericarditis Clonazepam SS ORAL ORAL Sinus Bradycardia Alprazolanum C Somnolence Loratadine C Suicide Attempt Date:04/18/02ISR Number: 3903411-3Report Type:Expedited (15-DaCompany Report #A206561 Age:42 YR Gender:Female I/FU:F Outcome PT Required Agitation Intervention to Akathisia Prevent Permanent Decreased Appetite Impairment/Damage Emotional Disorder Extrapyramidal Disorder 24-Jun-2005 12:19 PM Page: 1866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Increased Appetite Joint Stiffness Report Source Product Role Manufacturer Route Dose Duration Somnolence Health Ziprasidone Po PS 40.00 MG Tardive Dyskinesia Professional TOTAL:BID Weight Increased Zyprexa SS 20.00 MG TOTAL: DAILY Iron Supplements C Headache Medicine- Unspecified C Date:04/22/02ISR Number: 3904679-XReport Type:Expedited (15-DaCompany Report #2002-02-1107 Age:48 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Health Rebetol (Ribavirin) Multiple Congenital Professional Capsules PS ORAL 1200 MG QD Abnormalities Company ORAL Pregnancy Representative Intron A (Interferon Transmission Of Drug Via Alfa-2b Recombinant) Semen Injectable Solution SS SUBCUTANEOUS 3 MU TIW SUBCUTANEOUS Gabapentin SS Olanzapine SS Date:04/22/02ISR Number: 3904734-4Report Type:Expedited (15-DaCompany Report #A204048 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zoloft Tablets PS ORAL 50.00 MG Initial or Prolonged Depression Professional TOTAL:DAILY:O Required Diabetes Mellitus RAL Intervention to Drug Ineffective Wellbutrin SS ORAL 300.00 MG Prevent Permanent Fatigue TOTAL:BID:ORA Impairment/Damage Fear L Gait Disturbance Zyprexa SS ORAL 10.00 Hallucination, Visual TOTAL:DAILY:O Hemianopia RAL Insomnia Date:04/22/02ISR Number: 3905020-9Report Type:Expedited (15-DaCompany Report #A206161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Consumer Ziprasidone Po PS Intervention to Aggression Zyprexa (Olanzapine) SS Prevent Permanent Depression Xanax (Alprazolam) SS Impairment/Damage Intentional Self-Injury Obsessive-Compulsive Disorder Date:04/24/02ISR Number: 3906767-0Report Type:Expedited (15-DaCompany Report #EWC010125319 Age:40 YR Gender:Female I/FU:F Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 1867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Clostridial Infection Foreign Prozac (Fluoxetine Diarrhoea Health Hydrochloride) PS 40 MG DAY Disease Progression Professional Zyprexa (Olanzapine) SS 7.5 MG DAY Mycosis Fungoides Other Anafranil Recurrent (Clomipramine Pneumocystis Jiroveci Hydrochloride) C Pneumonia Respiratory Failure Date:04/24/02ISR Number: 3907052-3Report Type:Expedited (15-DaCompany Report #USA020413974 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Darvocet-N-. Syndrome Professional (Propoxyphene Company Napsylate) PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS Insulin C Date:04/26/02ISR Number: 3906857-2Report Type:Expedited (15-DaCompany Report #NSADSS2002012923 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Risperdal PS ORAL Initial or Prolonged Increased Zyprexa SS ORAL 26 DAY Anaemia Akineton C UNKNOWN Aspartate Halcion C UNKNOWN Aminotransferase Depas C UNKNOWN Increased Lendormin C UNKNOWN Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Date:04/29/02ISR Number: 3908371-7Report Type:Direct Company Report #CTU 166761 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disorientation Zyprexa 10mg PS QHS Clonidine C Neurontin C Valium C Trazodone C Folic Acid C Thiamine C Effexor Xr C Motrin C 24-Jun-2005 12:19 PM Page: 1868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/02ISR Number: 3909109-XReport Type:Direct Company Report #CTU 166881 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Zyprexa (Olanzapine) PS ORAL 20MG HS, PO Initial or Prolonged Non-Insulin-Dependent Effexor C Diabetic Ketoacidosis Nortriplyline C Urinary Tract Infection Glucoptose C Klonopin C Date:04/29/02ISR Number: 3909408-1Report Type:Expedited (15-DaCompany Report #US_020281894 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:04/29/02ISR Number: 3909410-XReport Type:Expedited (15-DaCompany Report #US_020180309 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Olanzapine-Oral Initial or Prolonged Blood Pressure Increased Health (Olanzapine) PS Haematemesis Professional Clonopin Hallucination, Auditory (Clonazepam) C Heart Rate Increased Vasotec (Enalapril Irritability Maleate) C Psychomotor Hyperactivity Tylenol Psychotic Disorder (Paracetamol) C Vomiting Projectile Depakote (Valproate Semisodium) C Date:04/29/02ISR Number: 3909655-9Report Type:Expedited (15-DaCompany Report #AU_020304858 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa-Oral Drug Toxicity Health (Olanzapine) Restrictive Pulmonary Professional (Olanzapine) PS 10 MG/DAY 4 DAY Disease Other Fluanxol (Flupentixol Dihydrochloride) C Date:04/29/02ISR Number: 3910316-0Report Type:Expedited (15-DaCompany Report #US_020483513 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chromaturia Foreign Zyprexa-Oral Condition Aggravated Health (Olanzapine) PS ORAL 15 MG/DAY Dialysis Professional Akineton (Biperiden Myoglobinuria Company Hydrochloride) C Rhabdomyolysis Representative Rohypnol Tremor (Flunitrazepam) C Water Intoxication Neuleptil White Blood Cell Count (Periciazine) C Increased Noritren 24-Jun-2005 12:19 PM Page: 1869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nortriptyline Hydrochloride) C Hiberna (Promethazine Hydrochloride) C Levotomin (Levomepromazine Maleate) C Contomin (Chlorpromazine Hydrochloride) C Benzalin (Nitrazepam) C Date:04/29/02ISR Number: 3910388-3Report Type:Expedited (15-DaCompany Report #NSADSS2002012923 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Other Anaemia Professional DAY(S), ORAL Aspartate Zyprexa (Olanzapine) SS ORAL 5 MG, DAILY, Aminotransferase ORAL Increased Akineton(Biperiden Hepatic Function Abnormal Hydrochloride) C Halcion (Triazolam) C Depas (Etizolam) C Lendormin (Brotizolam) C Date:04/29/02ISR Number: 3910432-3Report Type:Expedited (15-DaCompany Report #DE_020408441 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Foreign Zyprexa-Oral Initial or Prolonged Chromaturia Health (Olanzapine) PS 20 MG/DAY Difficulty In Walking Professional Ciatyl-Z Malaise (Zuclopenthixol Myalgia Hydrochloride) C Rhabdomyolysis Timonil - Slow Schizophrenia Release (Carbamazepine) C Diazepam C Date:04/29/02ISR Number: 3910436-0Report Type:Expedited (15-DaCompany Report #DE_020308190 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) Chromaturia Professional (Olanzapine) PS 10 MG/2 DAY Loss Of Consciousness Xanef (Enalapril Pyrexia Maleate) C Renal Impairment Dytide H C Rhabdomyolysis Norvasc (Amlodipine Tachycardia Besilate) C Diazepam C Tavor (Lorazepam) C Akineton (Biperiden 24-Jun-2005 12:19 PM Page: 1870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Citayl-Z Acuphase (Zuclopenthixol Acetate) C Date:04/29/02ISR Number: 3910936-3Report Type:Expedited (15-DaCompany Report #US_020382774 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperglycaemic Foreign Zyprexa-Oral Life-Threatening Coma Health (Olanzapine) Hospitalization - Dialysis Professional (Olanzapine) PS 50 MG/DAY Initial or Prolonged Disseminated Company Prothiaden Other Intravascular Coagulation Representative (Dosulepin) C Eye Disorder Other Levotomin Hepatic Steatosis (Levomepromazine Neuroleptic Malignant Maleate) C Syndrome Rohypnol Pharyngeal Oedema (Flunitrazepam) C Renal Disorder Limas (Lithium Shock Carbonate) C Staphylococcal Infection Halcion(Triazolam) C Water Intoxication Weight Increased Date:04/30/02ISR Number: 3908654-0Report Type:Direct Company Report #CTU 166887 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Olanzapine PS ORAL 20MG PO QHS Olanzapine SS ORAL 10MG PO QD Lorazepam C Valproic Acid C Propranolol C Hctz C Date:04/30/02ISR Number: 3909236-7Report Type:Direct Company Report #CTU 166928 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Valproic Acid PS ORAL 20GM PO X 1 Hospitalization - Ammonia Increased DOSE Initial or Prolonged Anger Olanzapine SS ORAL 52.5MG X PO 1 Required Drug Level Increased DOSE Intervention to Hallucination, Visual Prevent Permanent Intentional Misuse Impairment/Damage Paranoia Screaming Suicidal Ideation Date:04/30/02ISR Number: 3910400-1Report Type:Expedited (15-DaCompany Report #US_020483714 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Other Condition Aggravated Foreign Electrocardiogram Qt Health Corrected Interval Professional Prolonged Company 24-Jun-2005 12:19 PM Page: 1871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/ DAY Date:04/30/02ISR Number: 3910401-3Report Type:Expedited (15-DaCompany Report #US_020483757 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Foreign Zyprexa-Oral Fall Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Risperdal Representative (Risperidone) C Other Rohypnol (Flunitrazepam) C Pursennid (Senna Leaf) C Date:04/30/02ISR Number: 3910430-XReport Type:Expedited (15-DaCompany Report #GBS020210276 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Zyprexa-Oral Pulmonary Congestion Health (Olanzapine) Pulmonary Embolism Professional (Olanzapine) PS 20 MG Pulmonary Infarction Other Pulmonary Oedema Date:04/30/02ISR Number: 3910453-0Report Type:Expedited (15-DaCompany Report #EWC020430663 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Zyprexa-Oral Initial or Prolonged Hallucination Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Seroxat (Paroxetine Hydrochloride) C Sobril (Oxazepam) C Flunitrazepam C Voltaren (Diclofenac Sodium) C Date:04/30/02ISR Number: 3910455-4Report Type:Expedited (15-DaCompany Report #EWC020430652 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Zyprexa-Oral Initial or Prolonged Infarction Health (Olanzapine) Lipids Increased Professional (Olanzapine) PS Weight Increased Other 24-Jun-2005 12:19 PM Page: 1872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/02ISR Number: 3910514-6Report Type:Expedited (15-DaCompany Report #USA020414416 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa - Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:04/30/02ISR Number: 3910517-1Report Type:Expedited (15-DaCompany Report #USA020414202 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 2.5 MG/DAY Ativan (Lorazepam) C Date:04/30/02ISR Number: 3910738-8Report Type:Expedited (15-DaCompany Report #US_020483496 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphemia Literature Olanzapine - Oral Initial or Prolonged Hallucinations, Mixed Health (Olanzapine) PS 10 MG/DAY 8 DAY Serotonin Syndrome Professional Mirtazapine C Tramadol C Date:04/30/02ISR Number: 3910740-6Report Type:Expedited (15-DaCompany Report #USA020413926 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dystonia Health Zyprexa-Oral Other Overdose Professional (Olanzapine) Company (Olanzapine) PS 60 MG/DAY Representative Synthroid (Levothyroxine Sodium) C Date:04/30/02ISR Number: 3910742-XReport Type:Expedited (15-DaCompany Report #USA020414001 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa - Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Date:04/30/02ISR Number: 3910804-7Report Type:Expedited (15-DaCompany Report #US_020483586 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Olanzapine-Oral Inadequate Control Literature (Olanzapine) PS 30 MG/DAY Health Metformin C Professional Gliclazide C Other 24-Jun-2005 12:19 PM Page: 1873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/02ISR Number: 3911063-1Report Type:Expedited (15-DaCompany Report #A205737 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Consumer Navane Capsules PS ORAL 4.00 MG Initial or Prolonged Asthenia Health TOTAL: DAILY: Required Bronchitis Professional ORAL Intervention to Chronic Obstructive Nicotine SS Prevent Permanent Pulmonary Disease Zyprexa SS ORAL 2.50 MG Impairment/Damage Confusional State TOTAL: DAILY: Drug Withdrawal Syndrome ORAL Extrapyramidal Disorder Depakote SS ORAL ORAL Fear Timoptic C Feeling Abnormal Influenza Like Illness Screaming Date:04/30/02ISR Number: 3911404-5Report Type:Expedited (15-DaCompany Report #US_020483708 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Olanzapine-Oral Initial or Prolonged Study (Olanzapine) PS 20 MG DAY Health Bromperidol C Professional Carbamazepine C Other Flunitrazepam C Midorine C Marzulene S C Trihexyphenidyl C Bethanechol C Tinelac (Sennoside A&B) C Clonazepam C Date:04/30/02ISR Number: 3911405-7Report Type:Expedited (15-DaCompany Report #EWC020430632 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Olanzapine-Oral Hospitalization - Mouth Haemorrhage Health (Olanzapine) PS 30 MG/DAY Initial or Prolonged Parotitis Professional Augmentin C Platelet Count Decreased Company Fraxiparine Staphylococcal Infection Representative (Heparin-Fraction, Other Calcium Salt) C Orfiril (Valproate Sodium) C Date:04/30/02ISR Number: 3911408-2Report Type:Expedited (15-DaCompany Report #US_020483713 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa Hospitalization - Loss Of Consciousness Health (Olanzapine) PS ORAL Initial or Prolonged Professional Other Company Representative Other 24-Jun-2005 12:19 PM Page: 1874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/02ISR Number: 3909253-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11735347 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Olanzapine PS ORAL Initial or Prolonged Pyrexia Professional Prednisone Acetate SS 50 mg from 14 Mar 02 to 27 Mar 02; 25 mg from 28 Mar 02. Coversyl C Hctz C Date:05/01/02ISR Number: 3909994-1Report Type:Direct Company Report #CTU 167010 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Citalopram 20mg Q Am PS Olazapine SS Gabapentin SS Date:05/03/02ISR Number: 3912146-2Report Type:Direct Company Report #CTU 167275 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Zyprexa PS ORAL 15MG QHS PO Non-Insulin-Dependent Klonopin C Diabetic Ketoacidosis Trazodone C Insulin Resistance Respiratory Failure Date:05/06/02ISR Number: 3912609-XReport Type:Expedited (15-DaCompany Report #A209482 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zoloft Tablets PS ORAL 50.00 MG Initial or Prolonged Convulsion Health TOTAL:DAILY:O Dyspnoea Professional RAL Mental Disorder Other Levodopa + Normochromic Normocytic Benserazide SS ORAL DAILY:ORAL Anaemia Olanzapine SS ORAL 2.50 MG Persecutory Delusion TOTAL:ORAL Glyceryl Nitrate SS ORAL 5.00 MG TOTAL:DAILY:O RAL Moclobemide C Paracetamol C Tobramycin C Macrogol 4000 C Date:05/07/02ISR Number: 3913278-5Report Type:Expedited (15-DaCompany Report #A206561 Age:42 YR Gender:Female I/FU:F Outcome PT Required Agitation Intervention to Akathisia Prevent Permanent Decreased Appetite Impairment/Damage Dyskinesia 24-Jun-2005 12:19 PM Page: 1875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Elevated Mood Extrapyramidal Disorder Fatigue Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Health Ziprasidone Po PS 40.00 MG Somnolence Professional TOTAL BID Tardive Dyskinesia Zyprexa SS 20.00 MG Weight Increased TOTAL DAILY Iron Supplements C Headache Medicine - Unspecified C Date:05/07/02ISR Number: 3913280-3Report Type:Expedited (15-DaCompany Report #US_020484035 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Shock Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Voltaren (Diclofenac Representative Sodium) C Other Lendormin (Brotizolam) C Date:05/07/02ISR Number: 3913283-9Report Type:Expedited (15-DaCompany Report #GBS020410618 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa Health -Oral(Olanzapine) Professional (Olanzapine) PS 20MG /DAY Company Valproate Sodium C Representative Lamotrigine C Other Date:05/07/02ISR Number: 3913286-4Report Type:Expedited (15-DaCompany Report #FR_020400932 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa (Olanzapine Nasopharyngitis Health ) (Olanzapine) PS 7.5 MG /DAY Professional Solinan Other (Amisulpride) C Date:05/07/02ISR Number: 3913289-XReport Type:Expedited (15-DaCompany Report #FR_020400914 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 15 MG /DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 1876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3913293-1Report Type:Expedited (15-DaCompany Report #US_020483882 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Company Myslee (Zolipidem Representative Tartrate) C Other Methycobal(Mecobalam in) C Abilit (Sulpiride) C Trihexyphenidyl Hydrochloride C Date:05/07/02ISR Number: 3913294-3Report Type:Expedited (15-DaCompany Report #US_020483864 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glucose Tolerance Foreign Zyprexa-Oral Initial or Prolonged Impaired Health (Olanzapine) Liver Disorder Professional (Olanzapine) PS 10 MG /DAY Company Lipitor Representative (Atorvastatin) C Other Simvastatin C Miradol (Sulpiride) C Akineton (Biperiden Hydrochloride) C Rivotril (Clonazepam) C Gasmotin (Mosapride Citrate) C Lendormin (Brotizolam) C Acyclovir C Date:05/07/02ISR Number: 3913412-7Report Type:Expedited (15-DaCompany Report #EWC020430739 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroxine Decreased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Date:05/07/02ISR Number: 3913413-9Report Type:Expedited (15-DaCompany Report #EWC020430699 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ischaemia Foreign Zyprexa-Oral Initial or Prolonged Leg Amputation Health (Olanzapine) Disability Polycythaemia Professional (Olanzapine) PS 5 MG/1 DAY Other Tranxene (Clorazepate Dipotassium) C Temazepam C 24-Jun-2005 12:19 PM Page: 1877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3913416-4Report Type:Expedited (15-DaCompany Report #DE_020208130 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-Oral Initial or Prolonged International Normalised Health (Olanzapine) Ratio Increased Professional (Olanzapine) PS 5 MG/DAY Prothrombin Time Abnormal Other Marcumar (Phenprocoumon) C Sepram (Citalopram Hydrobromide) C Diazepam C Dilatrend (Carvedilol) C Date:05/07/02ISR Number: 3913420-6Report Type:Expedited (15-DaCompany Report #AU_020404972 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Inflammation Foreign Olanzapine-Oral Thrombocytopenia Health (Olanzapine) PS 20 MG/DAY Professional Zuclopenthixol C Other Date:05/07/02ISR Number: 3913464-4Report Type:Expedited (15-DaCompany Report #FR_020400894 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Olanzapine-Oral Hospitalization - Cardiac Arrest Literature (Olanzapine) PS 420 MG/OTHER Initial or Prolonged Chemical Burns Of Eye Health Alprazolam C Drug Toxicity Professional Hyperkalaemia Other Ileus Paralytic Rhabdomyolysis Vomiting Date:05/07/02ISR Number: 3913596-0Report Type:Expedited (15-DaCompany Report #USA020414538 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Zyprexa-Oral Initial or Prolonged Abnormal Professional (Olanzapine)(Olanzap Renal Impairment ine) PS Rhabdomyolysis Depakote(Valproate Toxic Epidermal Semisodium) C Necrolysis Date:05/07/02ISR Number: 3913597-2Report Type:Expedited (15-DaCompany Report #USA020414709 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Zyprexa-Oral(Olanzap Cardiac Arrest Professional ine)(Olanzapine) PS 10 MG/DAY Company Representative 24-Jun-2005 12:19 PM Page: 1878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3913598-4Report Type:Expedited (15-DaCompany Report #US_020483285 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Study Olanzapine-Oral(Olan Initial or Prolonged Pulmonary Embolism Health zapine) PS Professional Zestril(Lisinopril) C Date:05/07/02ISR Number: 3913605-9Report Type:Expedited (15-DaCompany Report #USA020414690 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomania Health Prozac Weekly PS 90 MG/WEEK Initial or Prolonged Serotonin Syndrome Professional Prozac-Oral Company (Fluoxetine) Representative (Fluoxetine Hydrochloride) SS 40 MG/DAY Zyprexa- Oral (Olanzapine) SS 90 MG/ WEEK Date:05/07/02ISR Number: 3913665-5Report Type:Expedited (15-DaCompany Report #HQ2085029APR2002 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Literature Effexor Xr Hospitalization - Circulatory Collapse (Venlafaxine Initial or Prolonged Pulmonary Embolism Hydrochloride, Supraventricular Capsule, PS ORAL 225 MG 1X PER Tachycardia 1 DAY, ORAL Clonazepam (Clonazepam, ) SS ORAL 1 MG 1X PER 1 DAY, ORAL Olanzapine (Olanzapine, ) SS ORAL 20 MG 1X PER 1 DAY, ORAL Date:05/08/02ISR Number: 3914123-4Report Type:Expedited (15-DaCompany Report #US_020180775 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Olanzapine-Oral(Olan Constipation Study zapine) PS 10 MG DAY Headache Health Pursennid (Senna Increased Appetite Professional Leaf) C Lymphocyte Count Other Ferrous Sulfate C Decreased Neutrophil Count Increased Platelet Count Increased Weight Increased Date:05/08/02ISR Number: 3914125-8Report Type:Expedited (15-DaCompany Report #US_020382423 Age:24 YR Gender:Female I/FU:F Outcome PT Death Anxiety Aspiration Completed Suicide 24-Jun-2005 12:19 PM Page: 1879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Discomfort Emotional Disorder Fall Report Source Product Role Manufacturer Route Dose Duration Injury Asphyxiation Foreign Zyprexa-Oral(Olanzap Overdose Health ine)(Olanzapine) PS 10 MG/DAY Vomiting Professional Seroquel C Company Besacolin(Bethanecho Representative l Chloride) C Other Benzalin(Nitrazepam) C Rohypnol(Flunitrazep am) C Halcion(Triazolam) C Zolpidem Tartrate C Date:05/08/02ISR Number: 3914141-6Report Type:Expedited (15-DaCompany Report #DE_020408439 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa-Oral Initial or Prolonged Pericardial Effusion Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY A Other FEW MONTHS Novodigal (Digoxin) C Concor (Bisoprolol Fumarate) C Amarul (Glimepiride) C Tramal (Tramadol Hydrochloride) C Antra C Date:05/08/02ISR Number: 3914237-9Report Type:Expedited (15-DaCompany Report #US_020483713 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Hospitalization - Diabetes Mellitus Health (Olanzapine) Initial or Prolonged Glycosylated Haemoglobin Professional (Olanzapine) PS Other Increased Company Loss Of Consciousness Representative Myocardial Infarction Other Date:05/08/02ISR Number: 3914238-0Report Type:Expedited (15-DaCompany Report #US_020483714 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 1880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/02ISR Number: 3914939-4Report Type:Expedited (15-DaCompany Report #EWC011028709 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Foreign Olanzapine PS 1 MG/DAY Initial or Prolonged Haematemesis Study Tenormine (Atenolol) C Vomiting Health Skenan (Morphine Professional Sulfate) C Other Calcite D C Exelon (Rivastigmine Tartrate) C Motilium (Domperidone) C Umuline Profil 30 (Insulin Human Injection, Isophane) C Hydromorphone Hydrochloride C Lactulose C Date:05/08/02ISR Number: 3914942-4Report Type:Expedited (15-DaCompany Report #EWC020230051 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Exertional Foreign Zyprexa-Oral Initial or Prolonged Gamma-Glutamyltransferase Health (Olanzapine) PS 20 MG/DAY Increased Professional Haloperidol C Hypertension Other Lung Disorder Polyuria Renal Failure Weight Decreased Date:05/08/02ISR Number: 3914945-XReport Type:Expedited (15-DaCompany Report #GBS020109978 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Olanzapine-Oral Drug Level Above Health (Olanzapine) PS 20 MG/1 AT Therapeutic Professional BEDTIME Therapeutic Agent Company Chlorpromazine C Toxicity Representative Clomipramine C Other Procyclidine C Lorazepam C Date:05/08/02ISR Number: 3914994-1Report Type:Expedited (15-DaCompany Report #USA020110510 Age:78 YR Gender:Female I/FU:F Outcome PT Death Activated Partial Other Thromboplastin Time Prolonged Blood Bicarbonate Decreased Blood Creatine Phosphokinase Increased Blood Potassium Increased Blood Sodium Decreased Cardio-Respiratory Arrest 24-Jun-2005 12:19 PM Page: 1881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Failure Hyperbilirubinaemia Hypoglycaemia Report Source Product Role Manufacturer Route Dose Duration International Normalised Health Zyprexa-Oral Ratio Increased Professional (Olanzapine) PS 5 MG/IN THE Mental Status Changes EVENING 2 WK Platelet Count Decreased Coreg (Carvedilol) C Somnolence Multivitamin C Oscal (Calcium Carbonate) C Imodium(Loperamide Hydrochloride) C Coumadin (Warfarin Sodium) C Celexa (Citalopram Hydrobromide) C Zantac (Raniditine Hydrochloride) C Potassium Chloride C Lasix (Furosemide) C Antivert C Tylenol (Paracetamol C Maalox C Milk Of Magnesia C Date:05/09/02ISR Number: 3914371-3Report Type:Direct Company Report #CTU 167752 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinson'S Disease Zyprexa PS ORAL 15MG PO QHS Initial or Prolonged Depakote C Flomax C Klonopin C Imdur C Celexa C Lipitor C Dyazide C Asa C Date:05/10/02ISR Number: 3913889-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11735347 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erysipelas Olanzapine PS ORAL Initial or Prolonged Leukaemia Prednisone Acetate SS 50 mg from 14 Disability Neutropenia Mar 02 to 27 Mar 02; 25 mg from 28 Mar 02. Coversyl C Hctz C Losec C 24-Jun-2005 12:19 PM Page: 1882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/02ISR Number: 3914404-4Report Type:Direct Company Report #CTU 167805 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oedema Peripheral Zyprexa 7.5 Mg Qd/ Intervention to Lilly PS Lilly ORAL QD 7.5 MG PO Prevent Permanent Depakote C Impairment/Damage Date:05/10/02ISR Number: 3915722-6Report Type:Expedited (15-DaCompany Report #02-04-0358 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Clozapine - Ivax Hospitalization - Syndrome Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS ORAL 600MG QD ORAL Zyprexa Tablets SS ORAL ORAL Date:05/13/02ISR Number: 3916243-7Report Type:Expedited (15-DaCompany Report #A207676 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Ziprasidone PS ORAL 40.00 MG Hospitalization - Electrocardiogram Qt Health TOTAL:DAILY:O Initial or Prolonged Corrected Interval Professional RAL Prolonged Olanzapine SS ORAL ORAL Insomnia Fluoxetine SS ORAL ORAL Loss Of Consciousness Clonazepam SS ORAL ORAL Pericarditis Alprazolanum C Sinus Bradycardia Loratadine C Somnolence Suicide Attempt Date:05/13/02ISR Number: 3916546-6Report Type:Expedited (15-DaCompany Report #D0038482A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Foreign Eskalith Initial or Prolonged Somnolence Health Tablet-Controlled Suicide Attempt Professional Release (Lithium Carbonate) PS ORAL SINGLE DOSE / ORAL Galantamine Hydrobromide Tablet (Galantamine Hydrobromide) SS ORAL SINGLE DOSE / ORAL Olanzapine Tablet (Olanzapine) SS ORAL SINGLE DOSE / ORAL Venlafaxine Hydrochloride Tablet (Venlafaxine Hydrochloride) SS ORAL SINGLE DOSE / ORAL Amitriptyline Hcl Tablet (Amitriptyline Hcl) SS ORAL SINGLE DOSE / ORAL 24-Jun-2005 12:19 PM Page: 1883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/02ISR Number: 3916945-2Report Type:Expedited (15-DaCompany Report #DE_020308313 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Zyprexa -Oral Initial or Prolonged Jaundice Health (Olanzapine)(Olanzap Professional ine) PS 10 MG /DAY Other Novodigal (Digoxin) C Tavor (Lorazepam) C Date:05/15/02ISR Number: 3917135-XReport Type:Expedited (15-DaCompany Report #US_020483757 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Increased Foreign Zyprexa-Oral Other Diabetic Coma Health (Olanzapine) Diabetic Ketoacidosis Professional (Olanzapine) PS 5 MG/DAY Fall Company Risperdal Representative (Risperidone) C Other Rohypnol (Flunitrazepam) C Pursennid (Senna Leaf) C Pyramistin (Trihexyphenidyl Hydrochloride) C Date:05/15/02ISR Number: 3917136-1Report Type:Expedited (15-DaCompany Report #EWC020430632 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Culture Positive Foreign Olanzapine-Oral Hospitalization - Drug Interaction Health (Olanzapine) PS 30 MG/DAY Initial or Prolonged Drug Level Above Professional Augmentin C Therapeutic Company Fraxiparine Gingival Bleeding Representative (Heparin-Fraction, Parotitis Other Calcium Salt) C Petechiae Orfiril (Valproate Staphylococcal Infection Sodium) C Thrombocytopenia .. C .. C .. C .. C .. C .. C .. C .. C .. C Date:05/15/02ISR Number: 3917138-5Report Type:Expedited (15-DaCompany Report #AU_020204732 Age:20 YR Gender:Male I/FU:F Outcome PT Life-Threatening Bronchopneumonia Hospitalization - Cardiomyopathy Initial or Prolonged Circulatory Collapse Dilatation Ventricular Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 1884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Sepsis Ventricular Hypokinesia Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 15 MG/DAY Professional Zuclopenthixol C Other Date:05/15/02ISR Number: 3917139-7Report Type:Expedited (15-DaCompany Report #GBS020410618 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Valproate Sodium C Representative Lamotrigine C Other Date:05/15/02ISR Number: 3917143-9Report Type:Expedited (15-DaCompany Report #US_020382645 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Olanzapine-Oral Cardiac Arrest Study (Olanzapine) PS 5 MG DAY Cardiovascular Disorder Health Clofekton Cerebrovascular Disorder Professional (Clocapramine Dysphagia Other Hydrochloride) C Faecal Incontinence Neuleptil Heart Rate Decreased (Periciazine) C Injury Asphyxiation Hirnamin Pulse Absent (Levomepromazine) C Respiratory Arrest Akineton (Biperiden Salivary Hypersecretion Hydrochloride) C Wheezing Magnesium Oxide C Effortil (Etilefrine Hydrochloride) C Hiberna (Promethazine Hydrochloride) C Benzalin (Nitrazepam) C Gaster (Famotidine) C Pursennid (Senna Leaf) C Dogmatyl (Sulpiride) C Date:05/15/02ISR Number: 3917246-9Report Type:Expedited (15-DaCompany Report #USA020515049 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 500 MG/DAY Representative Ambien (Zolpidem Tartrate) C 24-Jun-2005 12:19 PM Page: 1885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/02ISR Number: 3917260-3Report Type:Expedited (15-DaCompany Report #US_020584155 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arthralgia Foreign Zyprexa-Oral Back Pain Health (Olanzapine) Deep Vein Thrombosis Professional (Olanzapine) PS ORAL 10 MG/DAY Gait Disturbance Company Serenace Representative (Haloperidol) C Other Hirnamin (Levomepromazine) C Akineton (Biperiden Hydrochloride) C Gasmotin (Mosapride Citrate) C Doral (Quazepam) C Halomonth (Haloperidol Decanoate) C Date:05/15/02ISR Number: 3917262-7Report Type:Expedited (15-DaCompany Report #US_020484095 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa Condition Aggravated Health (Olanzapine) PS 10 MG/DAY Drowning Professional Psychiatric Symptom Company Representative Other Date:05/15/02ISR Number: 3917264-0Report Type:Expedited (15-DaCompany Report #US_020584157 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Representative Other Date:05/15/02ISR Number: 3917338-4Report Type:Expedited (15-DaCompany Report #USA020414824 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Zyprexa-Oral Other Respiratory Distress Professional (Olanzapine) Respiratory Failure Company (Olanzapine) PS 20 MG/2 DAY Viral Infection Representative Date:05/15/02ISR Number: 3917342-6Report Type:Expedited (15-DaCompany Report #USA020414728 Age:72 YR Gender:Male I/FU:I Outcome PT Death Circulatory Collapse Hospitalization - Difficulty In Walking Initial or Prolonged Disorientation 24-Jun-2005 12:19 PM Page: 1886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Loss Of Consciousness Staphylococcal Infection Report Source Product Role Manufacturer Route Dose Duration Tremor Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/DAY Sinemet C Mevacor(Lovastatin) C Dilacor (Digoxin) C Date:05/15/02ISR Number: 3917343-8Report Type:Expedited (15-DaCompany Report #USA020414746 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Health Zyprexa-Oral Initial or Prolonged Staphylococcal Infection Professional (Olanzapine) Other Stevens-Johnson Syndrome (Olanzapine) PS 3 WK Depakote(Valproate Semisodium) C Date:05/15/02ISR Number: 3917344-XReport Type:Expedited (15-DaCompany Report #USA020414731 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa-Oral Professional (Olanzapine) PS 20 MG/DAY Company Representative Date:05/16/02ISR Number: 3917561-9Report Type:Direct Company Report #CTU 168217 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Mydriasis Zyprexa 5mg 1x A Day Swelling Lilly Mfr PS Lilly 5MG A DAY Vasodilatation Date:05/20/02ISR Number: 3918902-9Report Type:Direct Company Report #CTU 168397 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Zyprexa Lilly PS Lilly 2.5 MG QD Depakote C Trazodone C Date:05/20/02ISR Number: 3918903-0Report Type:Direct Company Report #CTU 168398 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Swelling Zyprexa - Lilly PS Lilly 7.5 MG HS Depakote C Restoril C 24-Jun-2005 12:19 PM Page: 1887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/02ISR Number: 3936845-1Report Type:Expedited (15-DaCompany Report #USA020616478 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 40 MG/DAY Date:05/22/02ISR Number: 3921282-6Report Type:Expedited (15-DaCompany Report #US_020483285 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Study Olanzapine-Oral Initial or Prolonged Pulmonary Embolism Health (Olanzapine) PS Professional Zestril(Lisinopirl) C Date:05/22/02ISR Number: 3921660-5Report Type:Expedited (15-DaCompany Report #GBS020510638 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa Initial or Prolonged Liver Function Test Health (Olanzapine) PS 10 MG/DAY Abnormal Professional Largactil Other (Chlorpromazine Hydrochloride) C Seroxat (Paroxetine Hydrochloride) C Date:05/22/02ISR Number: 3922138-5Report Type:Expedited (15-DaCompany Report #USA020515330 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa-Oral Professional (Olanzapine) PS Date:05/22/02ISR Number: 3922363-3Report Type:Expedited (15-DaCompany Report #HQ8980428MAR2001 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Study Tavor (Lorazpeam, Initial or Prolonged Fall Tablet, Sublingual) PS ORAL 2.5 MG 1X PER Other Haemorrhage 1 DAY ORAL 1 DAY Head Injury Clomipramine Hyposthenuria (Clomipramine, ) SS ORAL SEE IMAGE 4 DAY Orthostatic Hypotension Diazepam (Diazepam, ) SS ORAL 20/15/10/5 MG 1X PER 1 DAY, ORAL 4 DAY Olanzapine (Olanzapine, ) SS ORAL SEE IMAGE 27 DAY Heparin (Heparin) C 24-Jun-2005 12:19 PM Page: 1888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3922420-1Report Type:Expedited (15-DaCompany Report #US_020483882 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Zyprexa-Oral Fall Health (Olanzapine) Rhabdomyolysis Professional (Olanzapine) PS 7.5 MG/DAY Company Myslee (Zolpidem Representative Tartrate) C Other Methycobal (Mecobalamin) C Abilit (Sulpiride) C Trihexyphenidyl Hydrochloride C Date:05/22/02ISR Number: 3922422-5Report Type:Expedited (15-DaCompany Report #DE_020107832 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Remergil (Mirtazapine) C Tavor (Lorazepam) C Date:05/22/02ISR Number: 3922424-9Report Type:Expedited (15-DaCompany Report #DE_020308313 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Novodigal (Digoxin) C Tavor (Lorazepam) C Date:05/22/02ISR Number: 3922425-0Report Type:Expedited (15-DaCompany Report #GBS011209836 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa-Oral Hospitalization - Atherosclerosis Health (Olanzapine) Initial or Prolonged Duodenal Ulcer Professional (Olanzapine) PS 15 MG/DAY Duodenal Ulcer Other Perforation Gastrointestinal Haemorrhage Nausea Protein Total Decreased Pulmonary Congestion Pulmonary Embolism Pulmonary Oedema Rectal Haemorrhage Spleen Congestion Upper Gastrointestinal Haemorrhage 24-Jun-2005 12:19 PM Page: 1889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3922427-4Report Type:Expedited (15-DaCompany Report #US_020483713 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Foreign Zyprexa-Oral Hospitalization - Aminotransferase Health (Olanzapine) Initial or Prolonged Increased Professional (Olanzapine) PS 5 MG/DAY Other Blood Creatine Company Blopress Phosphokinase Increased Representative (Candesartan Blood Lactate Other Cilexetil) C Dehydrogenase Increased Harnal (Tamsulosin Cardio-Respiratory Arrest Hydrochloride) C Diabetes Mellitus Norvasc (Amlodipine Glycosylated Haemoglobin Besilate) C Decreased Glimicron Loss Of Consciousness (Gliclazide) C Mydriasis Persantin Pupillary Reflex Impaired (Dipyridamole) C Date:05/22/02ISR Number: 3922428-6Report Type:Expedited (15-DaCompany Report #US_020483757 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Other Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 5 MG/DAY Aminotransferase Company Risperdal Increased Representative (Risperidone) C Blood Albumin Abnormal Other Rohypnol Blood Alkaline (Flunitrazepam) C Phosphatase Increased Pursennid (Senna Blood Amylase Increased Leaf) C Blood Bilirubin Increased Pyramistin Blood Creatinine Abnormal (Trihexyphenidyl Blood Glucose Increased Hydrochloride) C Blood Lactate Dehydrogenase Increased Blood Potassium Increased Blood Sodium Increased Blood Urea Increased Blood Uric Acid Increased Condition Aggravated Diabetic Coma Diabetic Ketoacidosis Fall Gamma-Glutamyltransferase Increased Lymphocyte Count Decreased Mental Disorder Monocyte Count Increased Movement Disorder Neutrophil Count Increased Platelet Count Decreased Protein Total Abnormal Red Blood Cell Count Abnormal Weight Increased White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 1890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3922435-3Report Type:Expedited (15-DaCompany Report #DE_020308190 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) General Physical Health Professional (Olanzapine) PS 10 MG/2 DAY Deterioration Other Xanef (Enalapril Loss Of Consciousness Maleate) C Pyrexia Dytide H C Renal Impairment Norvasc (Amlodipine Rhabdomyolysis Besilate) C Tachycardia Diazepam C Tavor (Lorazepam) C Akineton (Biperiden Hydrochloride) C Ciatyl-Z Acuphase (Zuclopenthixol Acetate) C Date:05/22/02ISR Number: 3922437-7Report Type:Expedited (15-DaCompany Report #DE_020208158 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Tachycardia Foreign Zyprexa-Oral Hospitalization - Cardiac Arrest Health (Olanzapine) Initial or Prolonged Cardiac Failure Professional (Olanzapine) PS 10 MG/DAY Cardiovascular Disorder Other Lorazepam C Dehydration Truxal Hypokalaemia (Chlorprothixene Mental Disorder Due To A Hydrochloride) C General Medical Condition Haloperidol C Myocardial Infarction Biperiden C Normochromic Normocytic Anaemia Pneumonia Pyrexia Red Blood Cell Sedimentation Rate Increased Restlessness Rhabdomyolysis White Blood Cell Count Decreased Date:05/22/02ISR Number: 3922603-0Report Type:Expedited (15-DaCompany Report #EWC020530850 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa-Oral Initial or Prolonged Dyspnoea Health (Olanzapine) Pneumonia Aspiration Professional (Olanzapine) PS 20 MG/DAY Pyrexia Company Tremor Representative Other 24-Jun-2005 12:19 PM Page: 1891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3922604-2Report Type:Expedited (15-DaCompany Report #GBS020510661 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Valproate Sodium C Lamotrigine C Date:05/22/02ISR Number: 3922605-4Report Type:Expedited (15-DaCompany Report #GBS020510668 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactoid Reaction Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Lithium Carbonate C Date:05/22/02ISR Number: 3922606-6Report Type:Expedited (15-DaCompany Report #US_020584382 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Serenace Representative (Haloperidol) C Other Tegretol (Carbamazepine) C Lodopin (Zotepine) C Hirnamin (Levomepromazine) C Date:05/22/02ISR Number: 3922748-5Report Type:Expedited (15-DaCompany Report #USA020515144 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/22/02ISR Number: 3922749-7Report Type:Expedited (15-DaCompany Report #USA020515251 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Health Zyprexa-Oral Life-Threatening Increased Professional (Olanzapine) Other Diabetic Ketoacidosis Company (Olanzapine) PS 15 MG/DAY Hypercholesterolaemia Representative Klonopin Respiratory Failure (Clonazepam) C Trazodone C 24-Jun-2005 12:19 PM Page: 1892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/02ISR Number: 3921585-5Report Type:Direct Company Report #CTU 168797 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa Zydis 5 Mg PS Zydis ORAL 5 MG PO QHS Initial or Prolonged Phosphokinase Abnormal Blood Creatinine Abnormal Blood Pressure Fluctuation Blood Urea Abnormal Chromaturia Lethargy Muscle Rigidity Neuroleptic Malignant Syndrome White Blood Cell Disorder Date:05/28/02ISR Number: 3924289-8Report Type:Expedited (15-DaCompany Report #A206561 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Ziprasidone Po PS 40.00 MG Intervention to Agitation Professional TOTAL:BID Prevent Permanent Akathisia Company Zyprexa SS 20.00 MG Impairment/Damage Athetosis Representative TOTAL:DAILY Bruxism Iron Supplements C Cogwheel Rigidity Headache Medicine C Condition Aggravated Dyskinesia Extrapyramidal Disorder Fatigue Hallucination, Auditory Joint Stiffness Mood Altered Movement Disorder Tardive Dyskinesia Weight Increased Date:05/28/02ISR Number: 3924319-3Report Type:Expedited (15-DaCompany Report #001-0073-M0200236 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Dilantin (Phenytoin Balance Disorder Professional Sodium) PS ORAL (UNKNOWN), Confusional State PER TUBE, PER Drug Level Above ORAL Therapeutic (Olanzapine) SS Drug Level Below (Rofecoxib) C Therapeutic (Alprazolam) C Fall (Risperidone) C Medication Error (Donepezil Mental Status Changes Hydrochloride) C Psychotic Disorder (Famotidine) C (Citalopram Hydrobromide) C (Heparin-Fraction, Sodium Salt) C 24-Jun-2005 12:19 PM Page: 1893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/02ISR Number: 3924335-1Report Type:Expedited (15-DaCompany Report #M0425-2002 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Literature Remeron PS 45 MG DAY Initial or Prolonged Tramadol SS 150 MG DAY Required Olanzapine SS 10 MG DAY Intervention to Prevent Permanent Impairment/Damage Date:05/29/02ISR Number: 3926019-2Report Type:Expedited (15-DaCompany Report #GBS020510661 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Valproate Sodium C Lamotrigine C Date:05/29/02ISR Number: 3926023-4Report Type:Expedited (15-DaCompany Report #US_020483714 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Zyprexa-Oral Condition Aggravated Health (Olanzapine) Electrocardiogram Qt Professional (Olanzapine) PS 20 MG/DAY Prolonged Company Triazolam C Representative Flunitrazepam C Other Date:05/29/02ISR Number: 3926033-7Report Type:Expedited (15-DaCompany Report #US_020483352 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Foreign Zyprexa-Oral Other Asthenia Health (Olanzapine) Blood Creatine Professional (Olanzapine) PS 5 MG/ DAY Phosphokinase Increased Company Doral(Quazepam) C Brain Contusion Representative Doral (Quazepam) C Brain Scan Abnormal Other Dogmatyl (Sulpiride) C Cerebral Haemorrhage Benzalin Contusion (Nitrazepam) C Disorientation Tagamet (Cimetidine) C Fall Pursennid (Senna Headache Leaf) C Infection Magnesium Oxide C Insomnia Muscle Injury Oedema Pyrexia Subdural Haematoma Urinary Incontinence White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 1894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/02ISR Number: 3926036-2Report Type:Expedited (15-DaCompany Report #US_020382388 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Health (Olanzapine) Syndrome Professional (Olanzapine) PS 250 MG/ DAY Overdose Company Rohypnol Pneumonia Representative (Flunitrazepam) C Rhabdomyolysis Other Suicidal Ideation Date:05/29/02ISR Number: 3926038-6Report Type:Expedited (15-DaCompany Report #US_020180775 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Olanzapine-Oral Condition Aggravated Study (Olanzapine) PS 10 MG DAY Constipation Health Pursennid (Senna Headache Professional Leaf) C Increased Appetite Other Ferrous Sulfate C Lymphocyte Count Decreased Neutrophil Count Increased Platelet Count Increased Weight Increased Date:05/29/02ISR Number: 3926043-XReport Type:Expedited (15-DaCompany Report #US_020483864 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Zyprexa-Oral Hospitalization - Insulin-Dependent Health (Olanzapine) Initial or Prolonged Hepatic Function Abnormal Professional (Olanzapine) PS 10 MG/DAY Other Hepatic Steatosis Company Lipitor Hepatitis Representative (Atorvastatin) C Increased Appetite Other Simvastatin C Weight Increased Miradol (Sulpiride) C Akineton (Biperiden Hydrochloride) C Rivotril (Clonazepam) C Gasmotin (Mosapride Citrate) C Lendormin (Brotizolam) C Acyclovir C Doral (Quazepam) C Date:05/29/02ISR Number: 3926094-5Report Type:Expedited (15-DaCompany Report #D0038587A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Eskalith Required Intentional Misuse Health Tablet-Controlled Intervention to Suicide Attempt Professional Release (Lithium Prevent Permanent Carbonate) PS ORAL 60 TABLET/ Impairment/Damage SINGLE DOSE/ 24-Jun-2005 12:19 PM Page: 1895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Olanzapine Tablet (Olanzapine) SS ORAL 27 TABLET/ SINGLE DOSE/ ORAL Date:05/29/02ISR Number: 3926158-6Report Type:Expedited (15-DaCompany Report #EWC020430771 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa-Oral Drug Level Above Health (Olanzapine) PS 5 MG/DAY Therapeutic Professional Maniprex (Lithium Electroencephalogram Company Carbonate) C Abnormal Representative Stilnoct (Zolipdem Grand Mal Convulsion Other Tartrate) C Xanax (Alprazolam) C Date:05/29/02ISR Number: 3926161-6Report Type:Expedited (15-DaCompany Report #US_020584418 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa Initial or Prolonged Hepatic Steatosis Health (Olanzapine) PS ORAL 20 MG/DAY Increased Appetite Professional Risperdal Weight Increased Company (Risperidone) C Representative Akineton (Biperiden Other Hydrochloride) C Anafranil (Clomipramine Hydrochloride) C Levotomin (Levomepromazine Maleate) C Benozil (Flurazepam Hydrochloride) C Vegetamin A C Date:05/29/02ISR Number: 3926184-7Report Type:Expedited (15-DaCompany Report #2002GB01254 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acidosis Foreign Quetiapine PS ORAL 150 MG BID PO Hospitalization - Dehydration Health Zyprexa SS ORAL 20 MG HS PO Initial or Prolonged Diabetic Ketoacidosis Professional Clozapine C Required Glycosylated Haemoglobin Other Intervention to Increased Prevent Permanent Weight Increased Impairment/Damage Date:05/29/02ISR Number: 3926683-8Report Type:Expedited (15-DaCompany Report #DE_011007083 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Foreign Zyprexa (Olanzapine) PS 10 MG/IN THE Hospitalization - Staphylococcal Sepsis Health EVENING Initial or Prolonged Professional Omeprazole C Other Delix (Ramipril) C 24-Jun-2005 12:19 PM Page: 1896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Novodigal(Digoxin) C Ibuprofen C Glucophage(Metformin Hydrochloride) C Amaryl(Glimepiride) C Kalinor(Potassium Chloride) C Haldol(Haloperidol) C Movicol C Omnic(Tamsulosin Hydrochloride) C Fragmin P Forte (Fragmin P Forte) C Date:05/29/02ISR Number: 3926684-XReport Type:Expedited (15-DaCompany Report #FR_020400894 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Olanzapine-Oral Hospitalization - Aspiration Literature (Olanzapine) PS OTHER 420 MG OTHER Initial or Prolonged Body Temperature Health Alprazolam C Other Decreased Professional Bradycardia Other Cardiac Arrest Chemical Burns Of Eye Coma Drug Interaction Drug Level Above Therapeutic Drug Toxicity Hyperkalaemia Hypotension Ileus Paralytic Mydriasis Overdose Renal Impairment Rhabdomyolysis Toxicologic Test Abnormal Urinary Incontinence Vomiting Date:05/30/02ISR Number: 3926832-1Report Type:Expedited (15-DaCompany Report #02-0842 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Loxitane (Loxapac) PS 50 MG 1X PER Initial or Prolonged Priapism Professional 1 DAY, 1 DAY Company Nozinan Representative (Levomepromazine) SS ORAL 100 DROP 1 X PER 1 DAY, PO Risperdal (Risperidone) SS ORAL 1 TABLET 1 X PER 1 DAY, ORAL 13 DAY Tercian (Cyamemazine) SS ORAL 120 DROP 1 X PER 1 DAY, ORAL Zyprexa (Olanzapine) SS ORAL 2 TABLET 1 X 24-Jun-2005 12:19 PM Page: 1897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PER 1 DAY, ORAL Imovane (Zopiclone) C Lepticur (Tropatepine Hydrochloride) C Date:05/30/02ISR Number: 3927720-7Report Type:Expedited (15-DaCompany Report #USA020515646 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Depakote (Valproate Semisodium) C Metformin C Glyburide C Date:05/30/02ISR Number: 3927721-9Report Type:Expedited (15-DaCompany Report #USA020515595 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Consumer Zyprexa-Oral Initial or Prolonged Hip Fracture (Olanzapine) Other Insomnia (Olanzapine) PS 2.5 MG/DAY 2 MON Somnolence Serzone (Nefazodone Hydrochloride) C Tamoxifen C Multivitamin C Date:05/30/02ISR Number: 3927835-3Report Type:Expedited (15-DaCompany Report #GBS020510715 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Cholestatic Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Epilim Chrono (Valproate Sodium) C Date:05/30/02ISR Number: 3927861-4Report Type:Expedited (15-DaCompany Report #GBS001106963 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa (Olanzapine) PS 3 WK Other Cardiovascular Disorder Consumer Dyspnoea Health Ejection Fraction Professional Decreased Other Pulmonary Oedema Ventricular Hypokinesia 24-Jun-2005 12:19 PM Page: 1898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/02ISR Number: 3927863-8Report Type:Expedited (15-DaCompany Report #FR_020500971 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Nausea Health (Olanzapine) Vomiting Professional (Olanzapine) PS 5 MG/DAY Company Lexomil (Bromazepam) C Representative Other Date:05/30/02ISR Number: 3927864-XReport Type:Expedited (15-DaCompany Report #DE_020508680 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) Myoglobin Blood Increased Professional (Olanzapine) PS 15 MG/DAY Other Lorazepam C Date:05/30/02ISR Number: 3927866-3Report Type:Expedited (15-DaCompany Report #GBS020510714 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infertility Male Foreign Zyprexa-Oral Sperm Count Decreased Health (Olanzapine) Professional (Olanzapine) PS 15 MG Other Date:05/30/02ISR Number: 3927868-7Report Type:Expedited (15-DaCompany Report #GBS020510712 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blepharitis Foreign Zyprexa-Oral Initial or Prolonged Cellulitis Orbital Consumer (Olanzapine) Condition Aggravated Other (Olanzapine) PS Diarrhoea Frequent Bowel Movements Gastrointestinal Pain Hepatitis A Ill-Defined Disorder Jaundice Malaise Nausea Oedema Peripheral Skin Inflammation Vein Disorder Vein Pain Weight Increased Date:05/30/02ISR Number: 3927870-5Report Type:Expedited (15-DaCompany Report #GBS020510675 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatomegaly Foreign Zyprexa-Oral Initial or Prolonged Hypersensitivity Health (Olanzapine) Professional (Olanzapine0 PS 5 MG/2 DAY Other Ranitidine C 24-Jun-2005 12:19 PM Page: 1899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone C Diazepam C Date:05/30/02ISR Number: 3927871-7Report Type:Expedited (15-DaCompany Report #FR_020500963 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa-Oral Initial or Prolonged Coma Literature (Olanzapine) Other Disseminated Health (Olanzapine) PS 20 MG/DAY Intravascular Coagulation Professional Carbamazepine C Drug Ineffective Other Levomepromazine C Hypothermia Alprazolam C Shock Date:05/30/02ISR Number: 3927890-0Report Type:Expedited (15-DaCompany Report #US_020483916 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Completed Suicide Foreign Zyprexa-Oral Contusion Health (Olanzapine) Schizophrenia Professional (Olanzapine) PS 20 MG/DAY Treatment Noncompliance Company Lendormin Representative (Brotizolam) C Other Fursennid (Senna Leaf) C Date:05/30/02ISR Number: 3927892-4Report Type:Expedited (15-DaCompany Report #DE_020508679 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Date:05/30/02ISR Number: 3927895-XReport Type:Expedited (15-DaCompany Report #DE_020207927 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Health (Olanzapine) Syndrome Professional (Olanzapine) PS 30 MG/DAY Psychotic Disorder Other Haldol (Haloperidol) C Euthyrox (Levothyroxine Sodium) C Tavor (Lorazepam) C Akineton Retard (Biperiden Hydrochloride) C Climopax C 24-Jun-2005 12:19 PM Page: 1900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/02ISR Number: 3928031-6Report Type:Expedited (15-DaCompany Report #USA020515553 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Zyprexa-Oral Agitation (Olanzapine) Anger (Olanzapine) PS 5 MG/DAY Asthenia Nasacort Confusional State (Triamcinolone Eyelid Oedema Acetonide) C Impaired Driving Ability Pulmicort Movement Disorder (Budesonide) C Reading Disorder Femhrt C Thinking Abnormal Herbal Extracts Nos C Tremor Vaginal Haemorrhage Visual Acuity Reduced Date:05/30/02ISR Number: 3928151-6Report Type:Expedited (15-DaCompany Report #USA020211344 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa-Oral Initial or Prolonged Amnesia Professional (Olanzapine) Aspartate Company (Olanazapine) PS 20 MG/DAY Aminotransferase Representative Zoloft (Sertraline Increased Hydrochloride) C Condition Aggravated Trazodone C Confusional State Ambien (Zolpidem Fall Tartrate) C Heart Rate Increased Ativan (Lorazepam) C Medication Error Cogentin Mental Impairment (Benzatropine Nephrogenic Diabetes Mesilate) C Insipidus Neuroleptic Malignant Syndrome Psychomotor Hyperactivity Psychotic Disorder Pyrexia Rhabdomyolysis Date:06/03/02ISR Number: 3926867-9Report Type:Direct Company Report #CTU 169345 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Olanzapine 10mg Initial or Prolonged Arthralgia Zyprexa PS ORAL 10MG QD ORAL Malaise Calcium-Vitamin Myalgia D-Oscal-D- C Nausea Multivitamis-Centrum Pyrexia Silver C Vomiting Acetaminophen C 24-Jun-2005 12:19 PM Page: 1901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/02ISR Number: 3968408-6Report Type:Periodic Company Report #A200685 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Increased Professional TOTAL:BID:ORA Amenorrhoea L Hypercholesterolaemia Zyprexa SS Tremor Tegretol Xr C Vomiting Centrum Vit Weight Decreased Supplement C Caltrate C Date:06/04/02ISR Number: 3928202-9Report Type:Expedited (15-DaCompany Report #D0038000A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lipase Increased Foreign Paxil Tablet Initial or Prolonged Health (Paroxetine Professional Hydrochloride) PS ORAL UNK/UNKNOWN/O RAL Olanzapine Tablet SS ORAL UNK/UNKNOWN/O RAL Haloperidol C Lorazepam C Amisulpride C Venlafaxine Hydrochloride C Date:06/04/02ISR Number: 3943964-2Report Type:Periodic Company Report #237292 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Dreams Consumer Lariam (Mefloquine Intervention to Anxiety Health Hydrochloride) 250 Prevent Permanent Confusional State Professional Mg PS ORAL 250 MG 1 PER Impairment/Damage Crying WEEK ORAL Depression Valium (Diazepam) SS Dissociation Risperdal Fatigue (Risperidone) SS Feeling Abnormal Zyprexa (Olanzapine) SS Hallucination Hallucination, Auditory Hallucination, Visual Hyperglycaemia Hyperventilation Jamais Vu Psychotic Disorder Suicidal Ideation Thinking Abnormal Tremor Date:06/05/02ISR Number: 3929902-7Report Type:Expedited (15-DaCompany Report #USA020515900 Age:79 YR Gender:Male I/FU:I Outcome PT Hospitalization - Cough Initial or Prolonged Dysphagia Other Dysuria 24-Jun-2005 12:19 PM Page: 1902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oesophageal Disorder Oral Intake Reduced Pneumonia Report Source Product Role Manufacturer Route Dose Duration Pneumonia Aspiration Health Zyprexa-Oral Staphylococcal Infection Professional (Olanzapine) Weight Decreased (Olanzapine) PS 15 MG/DAY Depakote C Xanax C Proscar C Ritalin C Date:06/05/02ISR Number: 3929903-9Report Type:Expedited (15-DaCompany Report #USA020516008 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chills Consumer Zyprexa Completed Suicide Zydis-Dispersible Dysphemia (Olanzapine) Heart Rate Increased (Olanzapine) PS 10 MG/DAY Medication Error Nightmare Social Avoidant Behaviour Suicidal Ideation Date:06/05/02ISR Number: 3929909-XReport Type:Expedited (15-DaCompany Report #S02-USA-00682-01 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Celexa (Citalopram Professional Hydrobromide) PS Zyprexa (Olanzapine) SS Parkinson'S Medication (Nos) C Date:06/05/02ISR Number: 3929927-1Report Type:Expedited (15-DaCompany Report #US_020584664 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Zyprexa-Oral Other Pneumonia Health (Olanzapine) PS Respiratory Failure Professional Viral Infection Company White Blood Cell Count Representative Decreased Date:06/05/02ISR Number: 3930149-9Report Type:Expedited (15-DaCompany Report #AU_020204732 Age:20 YR Gender:Male I/FU:F Outcome PT Life-Threatening Bronchopneumonia Hospitalization - Cardiomyopathy Initial or Prolonged Circulatory Collapse Dilatation Ventricular Dyspnoea Liver Function Test Abnormal Medication Error 24-Jun-2005 12:19 PM Page: 1903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Productive Cough Sepsis Report Source Product Role Manufacturer Route Dose Duration Ventricular Hypokinesia Foreign Olanzapine-Oral Health (Olanzapine) PS 15 MG/DAY Professional Zuclopenthixol C Other Date:06/05/02ISR Number: 3930151-7Report Type:Expedited (15-DaCompany Report #US_020483405 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Study (Olanzapine) PS 15 MG DAY Blood Bilirubin Increased Health Wintermin C-Reactive Protein Professional (Chlorpromazine Increased Other Hydrochloride) C Enterocolitis Diazepam C Gamma-Glutamyltransferase Artane Increased (Trihexyphenidyl Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Pursennid (Senna Leaf) C Magnesium Oxide C Biofermin R (Streptpcpccus Faecalis) C Simvastatin C Date:06/05/02ISR Number: 3930154-2Report Type:Expedited (15-DaCompany Report #US_020584382 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Zyprexa-Oral Pulse Absent Health (Olanzapine) Respiratory Arrest Professional (Olanzapine) PS 15 MG/DAY Company Serenace Representative (Haloperidol) C Other Tegretol (Carbamazepine) C Lodopin (Zotepine) C Barnetil (Sultopride) C Setous (Zotepine) C Hirnamin ( Levomepromazine) C Date:06/05/02ISR Number: 3930167-0Report Type:Expedited (15-DaCompany Report #EWC020531013 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Foreign Zyprexa-Oral Hospitalization - Hypoxia Health (Olanzapine) Initial or Prolonged Lung Infiltration Professional (Olanzapine) PS 40 MG/DAY Other Lamictal 24-Jun-2005 12:19 PM Page: 1904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lamotrigine) C Apozepam (Diazepam) C Truxal (Chlorprothixene Hydrochloride) C Levotrin C Litarex (Lithium Citrate) C Antabus (Disulfiram) C Date:06/05/02ISR Number: 3930173-6Report Type:Expedited (15-DaCompany Report #EWC020531005 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Hospitalization - Anxiety Health (Olanzapine) Initial or Prolonged Aortic Embolus Professional (Olanzapine) PS 5 MG/DAY Peripheral Embolism Other Risperdal (Risperidone) C Akineton (Biperiden Hydrochloride) C Valium (Diazepam) C Date:06/05/02ISR Number: 3930178-5Report Type:Expedited (15-DaCompany Report #US_020584729 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Memory Impairment Foreign Zyprexa-Oral Myocardial Infarction Health (Olanzapine) Somnolence Professional (Olanzapine) PS 10 MG/DAY Company Risperdal Representative (Risperidone) C Other Akineton (Biperiden Hydrochloride) C Rohypnol (Flunitrazepam) C Vegetamin B C Date:06/05/02ISR Number: 3930180-3Report Type:Expedited (15-DaCompany Report #FR_020500994 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Zyprexa- Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Representative Other Date:06/05/02ISR Number: 3930191-8Report Type:Expedited (15-DaCompany Report #FR_020501013 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aneurysm Foreign Zyprexa-Oral Initial or Prolonged Coronary Artery Disease Health (Olanzapine ) Myocardial Infarction Professional (Olanzapine) PS 2.5 MG /DAY Weight Increased Other Imovane(Zopiclone) C 24-Jun-2005 12:19 PM Page: 1905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/02ISR Number: 3930192-XReport Type:Expedited (15-DaCompany Report #FR_020501005 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematoma Foreign Olanzapine-Oral(Olan Initial or Prolonged Study zapine) PS 1 DSG Health FORM/DAY Professional Cordarone(Amiodarone Other Hydrochloriede) C Kaleorid (Potassium Chloride) C Lasilix (Furosemide) C Previscan(Fluindione ) C Triatec(Ramipril) C Doliprane(Paracetamo l) C Hemigoxine Nativelle(Digoxin) C Speciafoldine (Folic Acid) C Tardyferon (Ferous Sulfate) C Bromazepam C Deroxat (Paroxetine Hydrochloride) C Stilnox (Zolpidem) C Date:06/05/02ISR Number: 3930536-9Report Type:Expedited (15-DaCompany Report #US_020584673 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged Other (Olanzapine) PS Clozapine C Date:06/05/02ISR Number: 3930539-4Report Type:Expedited (15-DaCompany Report #US_020584672 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar Disorder Health Zyprexa-Oral Complications Of Maternal Professional (Olanzapine) Exposure To Therapeutic (Olanzapine) PS TRANSPLACENTAL Drugs Methadone C Drug Dependence Wellbutrin(Amfebutam Maternal Drugs Affecting one Hydrochloride) C Foetus Neonatal Disorder Date:06/05/02ISR Number: 3930542-4Report Type:Expedited (15-DaCompany Report #US_020584157 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Death Completed Suicide Foreign Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 1906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/DAY Gasmotin (Mosapride Citrate) C Yodel (Senna) C Sulpiride C Hiberna (Promethazine Hydrochloride) C Vegetamin A C Lendormin (Brotizolam) C Aldactone-A (Spironolactone) C Date:06/05/02ISR Number: 3930545-XReport Type:Expedited (15-DaCompany Report #US_020483708 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Olanzapine-Oral Initial or Prolonged Schizophrenia, Study (Olanzapine) PS 20 MG DAY Disorganised Type Health Bromperidol C Professional Carbamazepine C Other Flunitrazepam C Midodrine C Marzulene S C Trihexyphenidyl C Bethanechol C Tinelac (Sennoside A+B) C Clonazepam C Date:06/05/02ISR Number: 3930547-3Report Type:Expedited (15-DaCompany Report #FR_020100595 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Other Candidiasis Health (Olanzapine) Diabetic Hyperglycaemic Professional (Olanzapine) PS 10 MG/DAY Coma Company Fatigue Representative Glycosylated Haemoglobin Other Increased Hyperglycaemia Medication Error Urine Ketone Body Present Weight Increased Date:06/05/02ISR Number: 3930551-5Report Type:Expedited (15-DaCompany Report #EWC020430771 Age:23 YR Gender:Female I/FU:F Outcome PT Other Drug Interaction Drug Level Increased 24-Jun-2005 12:19 PM Page: 1907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Epilepsy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Maniprex (Lithium Representative Carbonate) C Other Stilnoct (Zolpidem Tartrate) C Xanax (Alprazolam) C Date:06/05/02ISR Number: 3930553-9Report Type:Expedited (15-DaCompany Report #EWC020430739 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroxine Free Decreased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 12.5 MG/DAY Other Xanor (Alprazolam) C Imovane (Zopiclone) C Date:06/05/02ISR Number: 3930596-5Report Type:Expedited (15-DaCompany Report #EWC020531040 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Lithium C Other Date:06/05/02ISR Number: 3930599-0Report Type:Expedited (15-DaCompany Report #US_020584726 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Foreign Zyprexa-Oral Initial or Prolonged Chest Pain Health (Olanzapine) PS 2.5 MG/DAY 4 MON Nocturnal Dyspnoea Professional Afrin C Tachycardia Other Date:06/05/02ISR Number: 3930601-6Report Type:Expedited (15-DaCompany Report #EWC020530981 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa Velotab Depression Health -Oral (Olanzapine) PS 20 MG/DAY Professional Loramet(Lormetazepam Other ) C Tranxilium(Clorazepa te Dipotassium) C Clopixol(Zuclopenthi xol Decanoate) C 24-Jun-2005 12:19 PM Page: 1908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/02ISR Number: 3930603-XReport Type:Expedited (15-DaCompany Report #GBS020510747 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Eyelid Ptosis Congenital Foreign Zyprexa-Oral Maternal Drugs Affecting Health (Olanzapine) PS TRANSPLACENTAL Foetus Professional Perinatal Brain Damage Company Representative Other Date:06/05/02ISR Number: 3930612-0Report Type:Expedited (15-DaCompany Report #FR_020200690 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Zyprexa-Oral Hepatocellular Damage Health (Olanzapine) Nausea Professional (Olanzapine) PS 10 MG/DAY Vomiting Other Depamide (Valpromide) C Date:06/05/02ISR Number: 3930617-XReport Type:Expedited (15-DaCompany Report #GBS020109978 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Olanzapine-Oral Drug Level Increased Health (Olanzapine) PS 20 MG/L AT Drug Toxicity Professional BEDTIME Dyspnoea Company Chlorpromazine C Respiratory Disorder Representative Clomipramine C Other Procyclidine C Lorazepam C Date:06/05/02ISR Number: 3930619-3Report Type:Expedited (15-DaCompany Report #FR_020100599 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Zyprexa-Oral Cytolytic Hepatitis Health (Olanzapine) Hepatocellular Damage Professional (Olanzapine) PS 15 MG/DAY Company Anapranil Representative (Clomipramine Other Hydrochloride) C Date:06/05/02ISR Number: 3930621-1Report Type:Expedited (15-DaCompany Report #DE_020308313 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Novodigal (Digoxin) C Tavor (Lorazepam) C 24-Jun-2005 12:19 PM Page: 1909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/02ISR Number: 3930625-9Report Type:Expedited (15-DaCompany Report #EWC010928145 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Olanzapine-Oral Hospitalization - Biopsy Bone Marrow Health (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Abnormal Professional Oxazepam C Blood Disorder Other Seroxat (Paroxetine Differential White Blood Hydrochloride) C Cell Count Abnormal Granulocytopenia Hodgkin'S Disease Leukopenia Mean Cell Volume Decreased Non-Hodgkin'S Lymphoma Skin Disorder Thrombocytopenia Date:06/07/02ISR Number: 3929803-4Report Type:Direct Company Report #CTU 169708 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Olanzapine 25 Mg PS ORAL 25 MG HS PO Initial or Prolonged Prolixin C Depakase C Congentin C Depakote C Date:06/07/02ISR Number: 3930270-5Report Type:Periodic Company Report #USA011110028 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) PS 5 MG/DAY Date:06/07/02ISR Number: 3930271-7Report Type:Periodic Company Report #USA011110030 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Health Zyprexa-Oral Initial or Prolonged Pulmonary Embolism Professional (Olanzapine) PS 30 MG/DAY Company Representative Date:06/07/02ISR Number: 3930272-9Report Type:Periodic Company Report #USA011210036 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Consumer Zyprexa-Oral Initial or Prolonged Intentional Misuse (Olanzapine) PS 37.5 MG/DAY Oligomenorrhoea Paxil (Paroxetine Hydrochloride) C Alprazolam C Wellbutrin (Amfebutamone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930273-0Report Type:Periodic Company Report #USA0200312809 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:06/07/02ISR Number: 3930274-2Report Type:Periodic Company Report #USA020313065 Age:67 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Professional (Olanzapine) PS 2.5 MG/DAY Company Aricept (Donepezil Representative Hydrochloride) C Reminyl (Galantamine) C Date:06/07/02ISR Number: 3930275-4Report Type:Periodic Company Report #USA020313019 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa-Oral Respiratory Arrest Professional (Olanzapine) PS Date:06/07/02ISR Number: 3930276-6Report Type:Periodic Company Report #USA020313015 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS Company Representative Date:06/07/02ISR Number: 3930277-8Report Type:Periodic Company Report #USA020312984 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysstasia Consumer Zyprexa-Oral Fall (Olanzapine) PS 15 MG/DAY Weight Decreased Date:06/07/02ISR Number: 3930278-XReport Type:Periodic Company Report #USA020312979 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Zyprexa-Oral Initial or Prolonged Mania Professional (Olanzapine) PS 30 MG/DAY Prescribed Overdose Eskalith Cr (Lithium Carbonate) C 24-Jun-2005 12:19 PM Page: 1911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930279-1Report Type:Periodic Company Report #USA020312903 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Consumer Zyprexa-Oral Photophobia (Olanzapine) PS 30 MG/DAY Prescribed Overdose Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Date:06/07/02ISR Number: 3930280-8Report Type:Periodic Company Report #USA020312832 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa-Oral PS 25 MG/DAY Prescribed Overdose Professional Depakote (Valproate Semisodium) C Lamictal (Lamotrigine) C Date:06/07/02ISR Number: 3930281-XReport Type:Periodic Company Report #USA020312773 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/2 DAY Prozac-Oral (Fluoxetine (Fluoxetine Hydrochloride) SS 20 MG/DAY Artane (Trihexyprhenidyl Hydrochloride) C Risperdal (Risperidone) C Date:06/07/02ISR Number: 3930282-1Report Type:Periodic Company Report #US_010769970 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Prozac-Oral PS 40 MG/DAY Initial or Prolonged Drug Effect Decreased Prozac Weekly-Weekly Fatigue (Once A Week Schizophrenia Formulation) (Flu SS 90 MG/1 WEEK Somnolence Zyprexa-Oral (Olanzapine) (Olanzapine) SS 15 MG/DAY Risperdal (Risperidone) C Date:06/07/02ISR Number: 3930283-3Report Type:Periodic Company Report #USA020311984 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Consumer Zyprexa-Oral Mania (Olanzapine) Weight Increased (Olanzapine) PS 20 MG/AT 24-Jun-2005 12:19 PM Page: 1912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report BEDTIME Accupril (Quinapril Hydrochloride) C Date:06/07/02ISR Number: 3930284-5Report Type:Periodic Company Report #USA020211794 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:06/07/02ISR Number: 3930285-7Report Type:Periodic Company Report #USA020313124 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Topamax (Topiramate) C (Amfebutamone Hydrochloride) C Seroquel C Date:06/07/02ISR Number: 3930286-9Report Type:Periodic Company Report #USA020211344 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa-Oral Syndrome Professional (Olanzapine) Company (Olanzapine) PS Representative Date:06/07/02ISR Number: 3930287-0Report Type:Periodic Company Report #USA020210994 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY 2 WK Representative Date:06/07/02ISR Number: 3930288-2Report Type:Periodic Company Report #USA020210939 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa-Oral Suicidal Ideation Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Neurontin (Gabapentin) C Lithium C Seroquel C 24-Jun-2005 12:19 PM Page: 1913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930289-4Report Type:Periodic Company Report #USA020210901 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Tardive Dyskinesia Company (Olanzapine) PS 15 MG/DAY Representative Prozac Weekly - Weekly (Once A Week Formulation) (Flu SS 180 MG/WEEK Date:06/07/02ISR Number: 3930290-0Report Type:Periodic Company Report #US_010974020 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged Congestive Prozac (Fluoxetine Somnolence Hydrochloride) SS 10 MG/1 DAY Gabapentin C Klonopin (Clonazepam) C Alprazolam C Lorazepam C Depakote (Valproate Semisodium) C Date:06/07/02ISR Number: 3930291-2Report Type:Periodic Company Report #US_010973211 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa (Olanzapine) PS Initial or Prolonged Weight Increased Date:06/07/02ISR Number: 3930293-6Report Type:Periodic Company Report #US_010770351 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa (Olanzapine) PS 30 MG/DAY Initial or Prolonged Prescribed Overdose Professional Clozapine C Other Depakote (Valproate Semisodium) C Lorazepam C Date:06/07/02ISR Number: 3930294-8Report Type:Periodic Company Report #US_000847178 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Consumer Humulin-Human Initial or Prolonged Blood Glucose Increased Insulin (Rdna): 30% Infection Regular, 70% Nph H PS 60 U/2 DAY Pruritus Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Humulin-Human Ultralente Insulin (Rdna) (Human Insu SS 10 U/1 DAY Humalog-. (Lispro) SS 24-Jun-2005 12:19 PM Page: 1914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa (Olanzapine) SS 10 MG/1 AT BEDTIME Haldol Decanoate (Haloperidol Decanoate) C Klonopin (Clonazepam) C Diphenhydramine C Hydroxyzine C Date:06/07/02ISR Number: 3930295-XReport Type:Periodic Company Report #US_000337431 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Zyprexa-Oral Initial or Prolonged Dyskinesia (Olanzapine) Fatigue (Olanzapine) PS 20 MG/DAY Schizophrenia Zyprexa Weight Increased Zydis-Dispersible (Olanzapine) (Olanzapine) SS 40 MG/DAY Date:06/07/02ISR Number: 3930296-1Report Type:Periodic Company Report #US_000337431 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Zyprexa-Oral Initial or Prolonged Dyskinesia (Olanzapine) Fatigue (Olanzapine) PS 20 MG/DAY Schizophrenia Zyprexa Weight Increased Zydis-Dispersible (Olanzapine) (Olanzapine) SS 40 MG/DAY Date:06/07/02ISR Number: 3930297-3Report Type:Periodic Company Report #USA020312250 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Health Zyprexa-Oral Initial or Prolonged Nausea Professional (Olanzapine) Pyrexia (Olanzapine) PS 2.5 MG/DAY Vomiting Depakote (Valproate Semisodium) C Date:06/07/02ISR Number: 3930298-5Report Type:Periodic Company Report #USA020312236 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Consumer Zyprexa-Oral Initial or Prolonged Sedation (Olanzapine) Tremor (Olanzapine) PS 50 MG/DAY 24-Jun-2005 12:19 PM Page: 1915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930299-7Report Type:Periodic Company Report #USA020312110 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY Representative Date:06/07/02ISR Number: 3930300-0Report Type:Periodic Company Report #US_011177720 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cerebrovascular Accident Consumer Zyprexa-Oral Fall (Olanzapine) Headache (Olanzapine) PS A FEW MONTHS Hemiparesis Loss Of Consciousness Memory Impairment Pyrexia Date:06/07/02ISR Number: 3930301-2Report Type:Periodic Company Report #US_011177418 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa (Olanzapine) PS 3 YR Initial or Prolonged Date:06/07/02ISR Number: 3930302-4Report Type:Periodic Company Report #US_011177244 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa (Olanzapine) PS 20 MG/DAY Syndrome Professional Lithium C Company Paxil (Paroxetine Representative Hydrochloride) C Date:06/07/02ISR Number: 3930303-6Report Type:Periodic Company Report #US_011177209 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Zyprexa (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Hypokinesia Celexa (Citalopram Increased Appetite Hydrobromide) C Pneumonia Fluorouracil C Somnolence Date:06/07/02ISR Number: 3930304-8Report Type:Periodic Company Report #US_011177115 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Zyprexa (Olanzapine) PS 20 MG/DAY Initial or Prolonged 24-Jun-2005 12:19 PM Page: 1916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930305-XReport Type:Periodic Company Report #US_011176976 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Dysarthria Professional (Olanzapine) Lethargy (Olanzapine) PS 5 MG/2 DAY Miosis Lithium C Wellbutrin (Amfebutamone Hydrochloride) C Topamax (Topiramate) C Carbatrol (Carbamazepine) C Levoxyl (Levothyroxine Sodium) C Date:06/07/02ISR Number: 3930306-1Report Type:Periodic Company Report #US_011076368 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:06/07/02ISR Number: 3930307-3Report Type:Periodic Company Report #US_011075261 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Zyprexa Initial or Prolonged Disorientation Other (Olanzapine) PS Fall Eskalith C Prilosec (Omeprazole) C Wellbutrin (Amfebutamone Hydrochloride) C Date:06/07/02ISR Number: 3930308-5Report Type:Periodic Company Report #US_011075156 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa Initial or Prolonged Professional (Olanzapine) PS Company Luvox (Fluvoxamine Representative Maleate) C Benzodiazepine C Date:06/07/02ISR Number: 3930309-7Report Type:Periodic Company Report #US_011074925 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Polycythaemia Health Zyprexa Initial or Prolonged Subarachnoid Haemorrhage Professional (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 1917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930310-3Report Type:Periodic Company Report #US_990420639 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa-Oral Initial or Prolonged Blood Triglycerides (Olanzapine) Other Increased (Olanzapine) PS 20 MG/1 DAY Convulsion Prozac-Oral Hallucination, Auditory (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG/1 DAY 3 YR Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Pepcid (Famotidine) C Topamax (Topiramate) C Date:06/07/02ISR Number: 3930311-5Report Type:Periodic Company Report #US_020382857 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa-Oral Initial or Prolonged Phosphokinase Increased (Olanzapine) Electrocardiogram Change (Olanzapine) PS Intentional Misuse Aleve (Naproxen Somnolence Sodium) C Depakote (Valproate Semisodium) C Date:06/07/02ISR Number: 3930312-7Report Type:Periodic Company Report #US_020382631 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Benadryl (Diphenhydramine Hydrochloride) C Date:06/07/02ISR Number: 3930313-9Report Type:Periodic Company Report #US_020382419 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 1918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930314-0Report Type:Periodic Company Report #US_020282043 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) PS 5 MG/1 DAY Hyperhidrosis Depakote (Valproate Hyperpyrexia Semisodium) C Hypertension Paroxetine C Hypoxia Lansoprazole C Incontinence Sinemet Cr C Mental Disorder Phenytoin C Tachycardia Bisacodyl C Tachypnoea Colace (Docusate Sodium) C Senokot (Senna Fruit) C Diazepam C Lorazepam C Date:06/07/02ISR Number: 3930315-2Report Type:Periodic Company Report #US_020180651 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Salivary Hypersecretion Health Zyprexa-Oral Initial or Prolonged Tardive Dyskinesia Professional (Olanzapine) Other (Olanzapine) PS Date:06/07/02ISR Number: 3930316-4Report Type:Periodic Company Report #US_011279464 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Insulin-Dependent (Olanzapine) PS 10 MG/1 IN Ketoacidosis THE EVENING YR Quetiapine C Promethazine C Benztropine C Date:06/07/02ISR Number: 3930317-6Report Type:Periodic Company Report #US_011178208 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:06/07/02ISR Number: 3930318-8Report Type:Periodic Company Report #US_011177941 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 1919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3930319-XReport Type:Periodic Company Report #US_011177745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:06/07/02ISR Number: 3930336-XReport Type:Periodic Company Report #USA020210797 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:06/07/02ISR Number: 3930337-1Report Type:Periodic Company Report #USA020210802 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Consumer Zyprexa-Oral Initial or Prolonged Joint Swelling (Olanzapine) Pneumonia (Olanzapine) PS 5 MG/DAY 2 WK Sleep Disorder Date:06/07/02ISR Number: 3930338-3Report Type:Periodic Company Report #USA020210814 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Consumer Zyprexa-Oral Initial or Prolonged Dysphagia (Olanzapine) Prescribed Overdose (Olanzapine) PS 22.5 MG/DAY Restlessness Visual Disturbance Weight Increased Date:06/07/02ISR Number: 3934080-4Report Type:Expedited (15-DaCompany Report #D0038633A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Eskalith Tablet - Initial or Prolonged Bowel Sounds Abnormal Health Controlled Release Dysarthria Professional (Lithium Carbonate) PS ORAL 90 TABLET/ Enuresis SINGLE DOSE/ Faecal Incontinence ORAL Haemodialysis Olanzapine Tablet Intentional Misuse (Olanzapine) SS ORAL 20 TABLET/ Suicide Attempt SINGLE DOSE/ ORAL Citalopram Tablet (Citalopram) SS ORAL 20 TABLET/ SINGLE DOSE/ ORAL Thyroxine Sodium Tablet (Levothyroxine 24-Jun-2005 12:19 PM Page: 1920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) SS ORAL 50 TABLET/ SINGLE DOSE/ ORAL Prothipendyl Hcl Tablet (Prothipendyl Hcl) SS ORAL 10 TABLET/ SINGLE DOSE/ ORAL Date:06/10/02ISR Number: 3931302-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR01472 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Nitriderm Tts Initial or Prolonged Choking Health (Glyceryl Dyspnoea Professional Trinitrate) Epilepsy Other Trans-Therapeutic-Sy Normochromic Normocytic stem PS TRANSDERMAL 5 MG, QD, Anaemia TRANSDERMAL Persecutory Delusion Zoloft (Sertraline Psychotic Disorder Hydrochloride) Capsule SS ORAL 50 MG/DAY, ORAL Moclamine (Moclobemide) Tablet SS ORAL 300 MG/DAY, ORAL Modopar (Benserazide Hydrochloride, Levodopa) Capsule SS ORAL 3 CAPS/DAY, ORAL Zyprexa (Olanzapine) Tablet SS ORAL 2.5 MG/DAY, ORAL Doliprane (Paracetamol) SS ORAL ORAL Forlax Powder (Macrogol) Powder SS ORAL ORAL Tobrex (Tobramycin Sulfate) Ey SS INTRAOCULAR OCULAR Date:06/10/02ISR Number: 3931377-9Report Type:Expedited (15-DaCompany Report #2002101362US Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Medrol(Methylprednis Grand Mal Convulsion Professional olone)Tablet PS ORAL ORAL 1 DAY Zyprexa (Olanzapine) SS Lithium (Lithium) SS Propranolol(Proprano lol) SS Levothyroxine(Levoth yroxine) SS Date:06/11/02ISR Number: 3930816-7Report Type:Direct Company Report #CTU 169841 Age: Gender:Male I/FU:I Outcome Required Intervention to 24-Jun-2005 12:19 PM Page: 1921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Zyprexa 2.5mg Lilly PS Lilly ORAL 2.5MG DAY ORAL Date:06/12/02ISR Number: 3932811-0Report Type:Expedited (15-DaCompany Report #US_020584766 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Of Chronic Literature Olanzapine-Oral Initial or Prolonged Disease Health (Olanzapine) PS 5 MG/3 DAY 3 YR Other Blood Potassium Decreased Professional Blood Pressure Decreased Blood Sodium Decreased Condition Aggravated Confusional State Cough Hallucination, Auditory Heat Stroke Hyperhidrosis Lethargy Neuroleptic Malignant Syndrome Pancytopenia Schizophrenia, Paranoid Type Sinusitis Date:06/12/02ISR Number: 3932892-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE00808 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Ludiomil Initial or Prolonged Oedema Peripheral Study (Maprotiline Pain In Extremity Health Hydrochloride) Professional Film-Coated Tablet PS ORAL SEE IMAGE Other Ludiomil (Maprotiline Hydrochloride) Solution For Injection SS INTRAVENOUS 50 - 150 MG/DAY, INTRAVENOUS Zyprexa (Olanzapine0 Film-Coated Tablet SS ORAL 2.5 MG/DAY, ORAL Ergenyl "Sanofi" Enteric-Film-Coated Tablet C Alna (Tamsulosin Hydrochloride) Slow Release Tablet C Staurodorm Neu (Flurazepam) Tablet C Diazepam Tablet C 24-Jun-2005 12:19 PM Page: 1922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3932944-9Report Type:Expedited (15-DaCompany Report #USA020516134 Age:0 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Communication Disorder Consumer Zyprexa PS ORAL Developmental Delay Clozapine C Maternal Drugs Affecting Foetus Premature Baby Date:06/12/02ISR Number: 3932946-2Report Type:Expedited (15-DaCompany Report #USA020516263 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa-Oral Hospitalization - Apnoea Professional (Olanzapine) Initial or Prolonged Blood Glucose Increased (Olanzapine) PS 800 MG Other Dystonia Hydrocodone Hypertension W/Acetaminophen C Intentional Misuse (Benzatropine Limb Deformity Mesilate) C Pneumocystis Jiroveci Venlafaxine C Pneumonia Vistaril C Respiratory Depression Gabapentin C Somnolence Ranitidine C Suicide Attempt Calcium C Docusate C Ibuprofen C Date:06/12/02ISR Number: 3932952-8Report Type:Expedited (15-DaCompany Report #USA020516020 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Pulmonary Embolism Professional (Olanzapine) Company (Olanzapine) PS Representative Date:06/12/02ISR Number: 3932968-1Report Type:Expedited (15-DaCompany Report #CA_011204621 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Olanzapine-Oral Coronary Artery Stenosis Health (Olanzapine) PS 20 MG AT Drug Toxicity Professional BEDTIME Epistaxis Other Ventolin Hyperthermia Malignant (Salbutamol) C Loss Of Consciousness Mouth Haemorrhage Pulmonary Congestion Pulmonary Oedema Scar Skin Discolouration Sudden Death 24-Jun-2005 12:19 PM Page: 1923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3932970-XReport Type:Expedited (15-DaCompany Report #US_020584724 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Diabetes Mellitus Study (Olanzapine) PS Health Professional Other Date:06/12/02ISR Number: 3932973-5Report Type:Expedited (15-DaCompany Report #US_020684888 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Completed Suicide Foreign Zyprexa-Oral Other Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS 10 MG/DAY Dialysis Company Artane Intentional Misuse Representative (Trihexyphenidyl Loss Of Consciousness Other Hydrochloride) C Pneumonia Aspiration Rohypnol Renal Failure (Flunitrazepam) C Rhabdomyolysis Suicide Attempt Vomiting Date:06/12/02ISR Number: 3932980-2Report Type:Expedited (15-DaCompany Report #US_020584813 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematochezia Foreign Zyprexa-Oral Consumer (Olanzapine) Other (Olanzapine) PS 2.5 MG/DAY Vascace (Cilazapril) C Date:06/12/02ISR Number: 3932982-6Report Type:Expedited (15-DaCompany Report #US_020584795 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa Oral Initial or Prolonged Malaise Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Silece Representative (Flunitrazepam) C Other Date:06/12/02ISR Number: 3932985-1Report Type:Expedited (15-DaCompany Report #EWC020531086 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Foreign Zyprexa-Oral Initial or Prolonged Drug Toxicity Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Depakin (Valproate Representative Sodium) C Other En (Delorazepam) C Luminal (Phenobarbital) C 24-Jun-2005 12:19 PM Page: 1924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3932987-5Report Type:Expedited (15-DaCompany Report #FR_020501030 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Legionella Infection Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Noctamide (Lormetazepam) C Nordaz (Nordazepam) C Date:06/12/02ISR Number: 3932990-5Report Type:Expedited (15-DaCompany Report #FR_020501018 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis B Antibody Foreign Zyprexa-Oral Positive Health (Olanzapine) Hepatocellular Damage Professional (Olanzapine) PS 10 MG/DAY Company Stablon (Tianeptine) C Representative Atarax (Hydroxyzine Other Hydrochloride) C Date:06/12/02ISR Number: 3932992-9Report Type:Expedited (15-DaCompany Report #FR_020501016 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extensor Plantar Response Foreign Zyprexa-Oral Initial or Prolonged Miosis Health (Olanzapine) Mood Swings Professional (Olanzapine) PS 10 MG/DAY Persecutory Delusion Other Lysanxia (Prazepam) C Somnolence Equanil Treatment Noncompliance (Meprobamate) C Aricept (Donepezil Hydrochloride) C Ditropan (Oxybutynin) C Date:06/12/02ISR Number: 3932994-2Report Type:Expedited (15-DaCompany Report #US_020584799 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Foreign Olanzapine-Oral Literature (Olanzapine) PS 30 MG/DAY Health Lithium Sulfate C Professional Valproate Sodium C Other Cannabis C Date:06/12/02ISR Number: 3932999-1Report Type:Expedited (15-DaCompany Report #EWC020531092 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Granulocytopenia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Lysantin (Orphenadrine Hydrochloride) C Dogmatil (Sulpiride) C 24-Jun-2005 12:19 PM Page: 1925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxapax (Oxazepam) C Stilnoct (Zolpidem Tartrate) C Dogmatil(Sulpiride) C Date:06/12/02ISR Number: 3933001-8Report Type:Expedited (15-DaCompany Report #DE_020508771 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Zyprexa-Oral Hospitalization - Insulin-Dependent Health (Olanzapine) Initial or Prolonged General Physical Health Professional (Olanzapine) PS 15 MG/DAY Deterioration Other Akineton (Biperiden Hydrochloride) C Truxal (Chlorprothixene Hydrochloride) C Glianimon (Benperidol C Haldol Decanoate (Haloperidol Decanoate) C Date:06/12/02ISR Number: 3933003-1Report Type:Expedited (15-DaCompany Report #DE_011207661 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Oral Initial or Prolonged Biopsy Bone Marrow Health (Olanzapine) Abnormal Professional (Olazapine) PS 5 MG/DAY Neutropenia Other Date:06/12/02ISR Number: 3933007-9Report Type:Expedited (15-DaCompany Report #US_020584836 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Olanzapine-Oral Hospitalization - Cerebrovascular Disorder Study (Olanzapine) PS ORAL 10 MG DAY Initial or Prolonged Convulsion Health Levomepromazine C Other Dyspnoea Professional Flunitrazepam C Hypoglycaemia Other Famotidiine C Loss Of Consciousness Carbamazepine C Miosis Date:06/12/02ISR Number: 3933024-9Report Type:Expedited (15-DaCompany Report #FR_020500963 Age:43 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Bradycardia Other Bronchopneumonia Cardiac Arrest Coma Cyanosis Disseminated Intravascular Coagulation Hepatocellular Damage 24-Jun-2005 12:19 PM Page: 1926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertonia Hypothermia Miosis Report Source Product Role Manufacturer Route Dose Duration Nosocomial Infection Foreign Zyprexa-Oral Oliguria Literature (Olanzapine) Pallor Health (Olanzapine) PS 10 MG/M2 DAY Peripheral Coldness Professional Carbamazepine C Proteus Infection Other Levomepromazine C Rhabdomyolysis Alprazolam C Shock Somnolence Ventricular Fibrillation Date:06/12/02ISR Number: 3933027-4Report Type:Expedited (15-DaCompany Report #EWC980400332 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Zyprexa-Oral Hospitalization - Arthritis Literature (Olanzapine) Initial or Prolonged Aspiration Bronchial Health (Olanzapine) PS 10 MG/2 DAY Blood Glucose Increased Professional Nozinan Bradycardia Other (Levomepromazine) C Bronchopneumonia Tegretol Bundle Branch Block Right (Carbamazepine) C Cardiac Arrest Xanax (Alprazolam) C Coma Mopral (Omeprazole) C Cyanosis Nifluril (Niflumic Disseminated Acid) C Intravascular Coagulation Electrocardiogram Abnormal Feeling Cold Gastritis Hepatic Failure Hepatocellular Damage Hiatus Hernia Hypertonia Hypothermia Miosis Nosocomial Infection Oedema Peripheral Pallor Proteus Infection Renal Failure Acute Rhabdomyolysis Shock Somnolence Ventricular Fibrillation Date:06/12/02ISR Number: 3936716-0Report Type:Expedited (15-DaCompany Report #D0038482A Age:53 YR Gender:Female I/FU:F Outcome PT Hospitalization - Convulsion Initial or Prolonged Disorientation Hypertension Intentional Misuse Somnolence Suicide Attempt 24-Jun-2005 12:19 PM Page: 1927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Foreign Eskalith Health Tablet-Controlled Professional Release (Lithium Carbonate) PS ORAL 3 TABLET / SINGLE DOSE/ ORAL Galantamine Hydrobromide Tablet (Galantamine Hydrobromide) SS ORAL 3 TABLET/ SINGLE DOSE/ ORAL Olanzapine Tablet (Olanzapine) SS ORAL 3 TABLET/ SINGLE DOSE/ ORAL Venlafaxine Hydrochloride Tablet (Venlafaxine Hydrochloride) SS ORAL 4 TABLET/ SINGLE DOSE/ ORAL Unknown Tablet (Unknown) SS ORAL SINGLE DOSE/ ORAL Amitriptyline Hcl Tablet (Amitriptyline Hcl) SS ORAL SINGLE DOSE/ ORAL Date:06/13/02ISR Number: 3933325-4Report Type:Direct Company Report #CTU 170161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Zyprexa 20mg PS ORAL 20MG PO QHS Initial or Prolonged Extrapyramidal Disorder Date:06/13/02ISR Number: 3934099-3Report Type:Expedited (15-DaCompany Report #EWC020530837 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extensor Plantar Response Foreign Zyprexa-Oral Initial or Prolonged Hyperreflexia Health (Olanzapine) Loss Of Consciousness Professional (Olanzapine) PS 20 MG DAY Movement Disorder Company Tegretol Overdose Representative (Carbamazepine) C Respiratory Disorder Other Suicide Attempt Toxicologic Test Abnormal 24-Jun-2005 12:19 PM Page: 1928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/02ISR Number: 3934103-2Report Type:Expedited (15-DaCompany Report #GBS020510714 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Infertility Male Foreign Zyprexa-Oral Sperm Count Decreased Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Other Date:06/13/02ISR Number: 3934138-XReport Type:Expedited (15-DaCompany Report #GBS020510712 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blepharitis Foreign Zyprexia- Oral Initial or Prolonged Bradykinesia Consumer (Olanzapine) Cellulitis Orbital Health (Olanzapine) PS 10 MG/DAY Condition Aggravated Professional Priadel(Lithium Extrapyramidal Disorder Carbonate) C Frequent Bowel Movements Zopiclone C Hepatitis A Temazepam C Hyperhidrosis Ill-Defined Disorder Malaise Musculoskeletal Stiffness Nausea Oedema Peripheral Rectal Tenesmus Salivary Hypersecretion Skin Inflammation Vein Disorder Vein Pain Weight Increased Date:06/13/02ISR Number: 3934350-XReport Type:Expedited (15-DaCompany Report #FR_020100552 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Foreign Zyprexa-Oral Hepatocellular Damage Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Stilnox (Zolpidem) C Date:06/13/02ISR Number: 3934351-1Report Type:Expedited (15-DaCompany Report #US_020584664 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decreased Activity Foreign Zyprexa-Oral Hospitalization - Dehydration Health (Olanzapine) Initial or Prolonged Eating Disorder Professional (Olanzapine) PS Other Neutrophil Count Company Serenace Increased Representative (Haloperidol) C Pancytopenia Other Hirnamin Pneumonia Viral (Levomepromazine) C Pyrexia Lexin Respiratory Failure (Carbamazepine) C Stupor Rohypnol Urinary Tract Infection (Flunitrazepam) C Magnesium Oxide C Gasmotin (Mosapride 24-Jun-2005 12:19 PM Page: 1929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citrate) C Pantosin (Pantethine) C Horizon (Diazepam) C Fero-Gradumet (Ferrous Sulfate) C Neuleptil (Periciazine) C Date:06/13/02ISR Number: 3934353-5Report Type:Expedited (15-DaCompany Report #US_020483713 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Oral Hospitalization - Infarction Health (Olanzapine) Initial or Prolonged Aspartate Professional (Olanzapine) PS 5 MG/DAY Other Aminotransferase Company Blopress Increased Representative (Candesartan Blood Creatine Other Cilexetil) C Phosphokinase Increased Harnal (Tamsulosin Cardiac Failure Hydrochloride) C Cardio-Respiratory Arrest Norvasc (Amlodipine Diabetes Mellitus Besilate) C Loss Of Consciousness Glimicron Mydriasis (Gliclazide) C Pupillary Reflex Impaired Persantin (Dipyridamole) C Date:06/13/02ISR Number: 3934451-6Report Type:Expedited (15-DaCompany Report #FR_020500963 Age:43 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Blood Bicarbonate Other Decreased Blood Lactic Acid Increased Blood Ph Increased Blood Pressure Decreased Bradycardia Bronchopneumonia Cardiac Arrest Cardiovascular Disorder Circulatory Collapse Coagulopathy Coma Cyanosis Disseminated Intravascular Coagulation Electrocardiogram Qrs Complex Prolonged Feeling Cold Hepatocellular Damage Hypertonia Hypothermia Nosocomial Infection Oliguria Pallor Pco2 Decreased Platelet Count Decreased 24-Jun-2005 12:19 PM Page: 1930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Po2 Decreased Protein Total Decreased Proteus Infection Report Source Product Role Manufacturer Route Dose Duration Pupils Unequal Foreign Zyprexa-Oral Respiratory Rate Literature (Olanzapine) Decreased Health (Olanzapine) PS 10 MG/2 DAY Rhabdomyolysis Professional Carbamazepine C Shock Other Levomepromazine C Somnolence Alprazolam C Ventricular Fibrillation Date:06/13/02ISR Number: 3934517-0Report Type:Expedited (15-DaCompany Report #US_020282032 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa-Oral(Olanzap Hospitalization - Attention Health ine)(Olanzapine) PS 210 MG/DAY Initial or Prolonged Deficit/Hyperactivity Professional Silece(Flunitrazepam Disorder Company ) C Blood Pressure Decreased Representative Serenace(Haloperidol Coma Other ) C Electrocardiogram Qt Akineton(Biperiden Prolonged Hydrochloride) C Hypokalaemia Magnesium Oxide C Hyponatraemia Lab B(Lactobacillus Logorrhoea Bifidus, Loss Of Consciousness Lyophilized) C Overdose Thrombocythaemia White Blood Cell Count Increased Date:06/17/02ISR Number: 3935148-9Report Type:Direct Company Report #CTU 170294 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Zyprexa -2.5mg-Eli Lilly PS Eli Lilly 2.5MG , 1X1DAY Effexor C Linethroid C Cytomel C Date:06/17/02ISR Number: 3935525-6Report Type:Expedited (15-DaCompany Report #2002UW01819 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Seroquel "Zeneca" PS Zeneca ORAL 800 MG DAILY Overdose Professional PO Olanzapine SS Effexor SS 24-Jun-2005 12:19 PM Page: 1931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/02ISR Number: 3935593-1Report Type:Expedited (15-DaCompany Report #NSADSS2002019628 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Haldol (Unspecified) Initial or Prolonged Syndrome Professional (Haloperidol) PS Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Date:06/18/02ISR Number: 3935918-7Report Type:Expedited (15-DaCompany Report #MK200206-0157-1 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Induced Foreign Anafranil 25 Mg Anal Atresia Health Capsules 100 PS 25MG, DAILY Complications Of Maternal Professional Depamide Exposure To Therapeutic (Valpromide) Drugs 600mg/Day SS Congenital Eye Disorder Theralene 10 Congenital Genital Drops/Day SS Malformation Zyprexa SS Congenital Musculoskeletal Anomaly Ear Malformation Fallot'S Tetralogy Foetal Disorder Gastrointestinal Disorder Congenital Limb Malformation Maternal Drugs Affecting Foetus Microgenia Multiple Congenital Abnormalities Oligohydramnios Placental Disorder Pregnancy Pulmonary Hypoplasia Urinary Tract Malformation Date:06/20/02ISR Number: 3936176-XReport Type:Direct Company Report #CTU 170561 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Zyprexa 20mg PS ORAL 20MG PO QHS Initial or Prolonged Extrapyramidal Disorder Date:06/20/02ISR Number: 3936588-4Report Type:Expedited (15-DaCompany Report #EWC020631185 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Nozinan (Levomepromazine) C 24-Jun-2005 12:19 PM Page: 1932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cisordinol (Clopenthixol Hydrochloride) C Disipal (Orphenadrine Hydrochloride) C Date:06/20/02ISR Number: 3936590-2Report Type:Expedited (15-DaCompany Report #EWC020631178 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Scan Abnormal Foreign Olanzapine - Oral Life-Threatening Cerebral Atrophy Health (Olanzapine) PS 10 MG/DAY Hospitalization - Coma Professional Dopamine Agonist C Initial or Prolonged Complex Partial Seizures Other Encephalitis Date:06/20/02ISR Number: 3936591-4Report Type:Expedited (15-DaCompany Report #EWC020631226 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Cholestatic Foreign Zyprexa-Oral Initial or Prolonged Hepatotoxicity Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:06/20/02ISR Number: 3936594-XReport Type:Expedited (15-DaCompany Report #US_020684963 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine ) Professional (Olanzapine) PS 10 MG/DAY Company Levotomin Representative (Levomeprazole Other Maleate) C Date:06/20/02ISR Number: 3936608-7Report Type:Expedited (15-DaCompany Report #DE_020608888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angiopathy Foreign Zyprexa-Oral Depressed Level Of Consumer (Olanzapine) Consciousness Other (Olanzapine) PS Dysgeusia Zyprexa Velotab-Oral Fatigue (Olanzapine) Photosensitivity Reaction (Olanzapine) SS Renal Disorder Johanniskraut-Kapsel n(Hypericum Extract) C Date:06/20/02ISR Number: 3936609-9Report Type:Expedited (15-DaCompany Report #DE_020608885 Age:34 YR Gender:Male I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Simple Partial Seizures 24-Jun-2005 12:19 PM Page: 1933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Status Epilepticus Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Tegretal - Slow Release (Carbamazepine) C Gabitril (Tiagabine Hydrochloride) C Date:06/20/02ISR Number: 3936611-7Report Type:Expedited (15-DaCompany Report #AU_020605094 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Olanzapine-Oral Initial or Prolonged Multi-Organ Failure Health (Olanzapine) PS 40 MG/DAY Nausea Professional Clozapine C Neuroleptic Malignant Other Valproate Sodium C Syndrome Respiratory Failure Date:06/20/02ISR Number: 3936612-9Report Type:Expedited (15-DaCompany Report #US_020584792 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Other Cardio-Respiratory Arrest Literature (Olanzapine) Cardiomegaly Health (Olanzapine) PS 15 MG/DAY Chest Discomfort Professional Propericiazine Oral Intake Reduced Company (Periciazine) C Pyrexia Representative Levomepromazine C Sudden Death Other Flunitrazepam C Supraventricular Biperiden C Extrasystoles Mosapride Citrate C Ventricular Extrasystoles Serrapeptase C Carbazochrome Sodium Sulfonate C Digoxin C Furosemide C Spironolactone C Date:06/20/02ISR Number: 3936613-0Report Type:Expedited (15-DaCompany Report #EWC020631202 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Zyprexa-Oral Initial or Prolonged Other (Olanzapine) (Olanzapine) PS Cipramil (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 1934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/02ISR Number: 3936614-2Report Type:Expedited (15-DaCompany Report #EWC020631184 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa-Oral Leukopenia Health (Olanzapine) Professional (Olanzapine) PS 105 MG/DAY Company Buspirone C Representative Other Date:06/20/02ISR Number: 3936843-8Report Type:Expedited (15-DaCompany Report #USA020110526 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Zyprexa-Oral Initial or Prolonged Anxiety Health (Olanzapine) Bone Marrow Depression Professional (Olanzapine) PS 1.25 MG/AT Chest Pain BEDTIME Constipation Depression Dyspnoea Exertional Eosinophilia Erythropoiesis Abnormal Hyperchromic Anaemia Microcytic Anaemia Oedema Peripheral Palpitations Rash Temperature Intolerance White Blood Cell Count Abnormal Date:06/20/02ISR Number: 3936844-XReport Type:Expedited (15-DaCompany Report #USA020616537 Age:2 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Blood Pressure Decreased (Olanzapine) Heart Rate Decreased (Olanzapine) PS 25 MG Somnolence Date:06/20/02ISR Number: 3936853-0Report Type:Expedited (15-DaCompany Report #USA020516414 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Zyprexa-Oral Initial or Prolonged Cardiac Enzymes Increased Professional (Olanzapine) Electrocardiogram (Olanzapine) PS 2.5 MG/DAY Abnormal Luvox (Fluvoxamine Maleate) C Date:06/20/02ISR Number: 3936854-2Report Type:Expedited (15-DaCompany Report #USA020516368 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Acute Health Zyprexa-Oral Initial or Prolonged Pyrexia Professional (Olanzapine) 24-Jun-2005 12:19 PM Page: 1935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS 10 MG/DAY Oscal 500-D C Centrum Silver C Date:06/20/02ISR Number: 3936855-4Report Type:Expedited (15-DaCompany Report #USA020616648 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa-Oral Ecchymosis Professional (Olanzapine) Oedema Peripheral Company (Olanzapine) PS 10 MG/DAY Weight Increased Representative Date:06/20/02ISR Number: 3936856-6Report Type:Expedited (15-DaCompany Report #USA020616581 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 15 MG/DAY Date:06/20/02ISR Number: 3936857-8Report Type:Expedited (15-DaCompany Report #USA020616539 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Health Zyprexa-Oral Initial or Prolonged Eosinophilia Professional (Olanzapine) Influenza Like Illness (Olanzapine) PS Lipase Increased Wellbutrin Liver Function Test (Amfebutamone Abnormal Hydrochloride) C Xanax (Alprazolam) C Date:06/21/02ISR Number: 3937560-0Report Type:Expedited (15-DaCompany Report #USA020110503 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Ph Increased Health Zyprexa - Oral Hospitalization - Diabetic Coma Professional (Olanzapine) Initial or Prolonged Rhabdomyolysis Company (Olanzapine) PS 20 MG/DAY Other Weight Increased Representative Loxitane (Loxapine Succinate) C Neurontin (Gabapentin) C Adalat (Nifedipine) C Tenormin (Atenolol) C Lasix (Furosemide) C Potassium C Synthroid (Levothyroxine Sodium) C Colchicine C Allopurinol C Iron Sulfate C 24-Jun-2005 12:19 PM Page: 1936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3937563-6Report Type:Expedited (15-DaCompany Report #USA020413674 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Hepatitis C Health (Olanzapine) ( Other Overdose Professional Olanzapine) PS 20 MG/DAY Pancreatitis Depakote (Valproate Weight Decreased Sodium) C Neurontin (Gabapentin) C Ambien (Zolpidem Tartrate) C Klonopin (Clonazepam) C Seroquel C Zantac (Ranitidine Hydrochloride) C Trileptal (Oxcarbazepine) C Date:06/21/02ISR Number: 3937923-3Report Type:Expedited (15-DaCompany Report #EWC010125319 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clostridium Colitis Foreign Prozac-Oral Hospitalization - Disease Progression Health (Fluoxetine) Initial or Prolonged Dyspnoea Professional (Fluoxetine Other Erythema Other Hydrochloride) PS 40 MG/DAY Hyperplasia Zyprexa-Oral Lymphoma (Olanzapine) Mycosis Fungoides (Olanzapine) SS 7.5 MG/DAY Pneumocystis Jiroveci Anafranil Pneumonia (Clomipramine Pneumonia Hydrochloride) C Psychiatric Symptom Atarax (Hydroxyzine Respiratory Failure Hydrochloride) C Skin Nodule Lexomil (Bromazepam) C Orap (Pimozide) C Solian (Amisulpride) C Effexor (Venlafaxine Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Date:06/21/02ISR Number: 3937930-0Report Type:Expedited (15-DaCompany Report #EWC020531040 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Lithium C Other 24-Jun-2005 12:19 PM Page: 1937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3937933-6Report Type:Expedited (15-DaCompany Report #EWC020230041 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG/DAY Professional Epilim (Valproate Company Sodium) C Representative Other Date:06/21/02ISR Number: 3937950-6Report Type:Expedited (15-DaCompany Report #US_020584795 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Foreign Zyprexa-Oral Hepatitis Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Silece Representative (Flunitrazepam) C Other Date:06/21/02ISR Number: 3937955-5Report Type:Expedited (15-DaCompany Report #US_020584729 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS 10 MG/DAY Hypertension Company Risperdal Myocardial Infarction Representative (Risperidone) C Somnolence Other Biperiden Hydrochloride C Rohypnol (Flunitrazepam) C Vegetamin B C Allorine (Allopurinol) C Date:06/21/02ISR Number: 3937989-0Report Type:Expedited (15-DaCompany Report #A117982 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Health Ziprasidone Po PS ORAL 160.00 MG Intervention to Drug Effect Decreased Professional TOTAL: BID: Prevent Permanent Dyspnoea ORAL Impairment/Damage Fluid Retention Zyprexa (Olanzapine) SS Pulmonary Oedema Celexa (Citalopram) C Respiratory Distress Xanax (Alprazolam) C Date:06/21/02ISR Number: 3938131-2Report Type:Expedited (15-DaCompany Report #A213033 Age: Gender:Male I/FU:I Outcome PT Report Source Required Rash Foreign Intervention to Suicide Attempt Health Prevent Permanent Urticaria Professional Impairment/Damage Company 24-Jun-2005 12:19 PM Page: 1938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Ziprasidone Po PS ORAL ORAL Zyprexa SS Tavor SS Alcohol SS Date:06/21/02ISR Number: 3938135-XReport Type:Expedited (15-DaCompany Report #USA020413705 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Health Zyprexa-Oral Overdose Professional (Olanzapine) Pancreatic Haemorrhage Company (Olanzapine) PS 25 MG DAY Representative Depakote (Valproate Semisodium) C Luvox (Fluvoxamine Maleate) C Date:06/21/02ISR Number: 3938285-8Report Type:Expedited (15-DaCompany Report #US_020382774 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Zyprexa-Oral Life-Threatening Anxiety Health (Olanzapine) Hospitalization - Blood Pressure Decreased Professional (Olanzapine) PS 10 MG DAY Initial or Prolonged Coma Company Prothiaden Other Dehydration Representative (Dosulepin) C Diabetic Hyperglycaemic Other Levotomin Coma (Levomepromazine Dialysis Maleate) C Disseminated Rohypnol Intravascular Coagulation (Flunitrazepam) C Dizziness Limas (Lithium Hepatic Steatosis Carbonate) C Loss Of Consciousness Halcion (Triazolam) C Neuroleptic Malignant Syndrome Pharyngeal Oedema Renal Disorder Rhabdomyolysis Shock Staphylococcal Infection Tachycardia Thirst Vomiting Water Intoxication Weight Increased Date:06/21/02ISR Number: 3938289-5Report Type:Expedited (15-DaCompany Report #GBS020510712 Age:66 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blepharitis Initial or Prolonged Cellulitis Orbital Condition Aggravated Extrapyramidal Disorder 24-Jun-2005 12:19 PM Page: 1939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Food Intolerance Frequent Bowel Movements Hepatitis Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Foreign Zyprexa-Oral Incontinence Consumer (Olanzapine) Nausea Health (Olanzapine) PS 10 MG/DAY Oedema Peripheral Professional Priadel (Lithium Rectal Tenesmus Other Carbonate) C Salivary Hypersecretion Zopiclone C Skin Inflammation Temazepam C Vein Pain Weight Increased Date:06/21/02ISR Number: 3938656-XReport Type:Expedited (15-DaCompany Report #A211896 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zoloft Tablets PS 100.00 MG Initial or Prolonged Confusional State Health TOTAL Decreased Appetite Professional Olanzapine SS 5.00 MG Dehydration Company TOTAL:DAILY Delirium Representative Alimemazine SS 10.00 Hallucination TOTAL:DAILY Hyponatraemia Risperidone C Zopiclone C Oxapam C Buflomedil C Urapidil C Irbesartan C Clorazepate C Date:06/24/02ISR Number: 3937929-4Report Type:Direct Company Report #CTU 170791 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Olanzapine PS Echocardiogram Abnormal Carbamazepine C Myocarditis Pulse Absent Syncope Ventricular Fibrillation Ventricular Tachycardia Date:06/25/02ISR Number: 3939403-8Report Type:Expedited (15-DaCompany Report #HQ2925324JUN2002 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Temesta (Lorazepam, Initial or Prolonged Contusion Professional Tablet) PS ORAL 3.5 MG 1X PER Other Drug Interaction 1 DAY ORAL 1 DAY Drug Level Increased Temesta (Lorazepam, Fall Tablet) SS 5.5 MG 1X PER Wound 1 DAY 2 DAY Temesta (Lorazepam, Tablet) SS 1 MG 1X PER 1 DAY 3 DAY Temesta (Lorazepam, Tablet) SS 5 MG 1X PER 1 24-Jun-2005 12:19 PM Page: 1940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY 2 DAY Temesta (Lorazepam, Tablet) SS 2.5 MG 1X PER 1 DAY 2 DAY Temesta (Lorazepam, Tablet) SS 2 MG/DAY MAXIMUM Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS 300 MG 1X PER 1 DAY 2 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS 1500 MG 1 X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS 600 MG 1X PER 1 DAY 2 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS 1200 MG 1X PER 1 DAY 3 DAY Quilonorm (Lithium Acetate, ) SS 900 MG 1X PER 1 DAY Zyprexa (Olanzapine, ) SS 10 MG 1X PER 1 DAY 12 DAY Zyprexa (Olanzapine, ) SS 12.5 MG 1X PER 1 DAY Eltroxin (Levothyroxine Sodium) C Diovan (Valsartan) C Zyloric (Allopurinol) C Akineton (Biperiden Hydrochloride) C Date:06/25/02ISR Number: 3939619-0Report Type:Expedited (15-DaCompany Report #EWC020631229 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Neoplasm Foreign Zyprexa-Oral Hospitalization - Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG/DAY 1 YR Company Representative Other 24-Jun-2005 12:19 PM Page: 1941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/02ISR Number: 3939620-7Report Type:Expedited (15-DaCompany Report #EWC020631272 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Trileptal (Oxcarbazepine) C Stilnox (Zolpidem) C Date:06/25/02ISR Number: 3939622-0Report Type:Expedited (15-DaCompany Report #EWC020631303 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Abdomen Foreign Olanzapine-Oral Initial or Prolonged Blood Cholesterol Health (Olanzapine) PS 15 MG/DAY Increased Professional Lithium C Blood Triglycerides Company Fluoxetine C Increased Representative Malaise Other Pancreatic Pseudocyst Pancreatitis Weight Increased Date:06/25/02ISR Number: 3939625-6Report Type:Expedited (15-DaCompany Report #EWC020631304 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Zyprexa-Oral Initial or Prolonged Dysphagia Health (Olanzapine) Salivary Hypersecretion Professional (Olanzapine) PS 10 MG/DAY Other Depakine (Valproate Sodium) C Tranxene (Clorazepate Dipotassium) C Etumine (Clotiapine) C Date:06/25/02ISR Number: 3939626-8Report Type:Expedited (15-DaCompany Report #FR_020601065 Age: Gender:Male I/FU:I Outcome PT Death Abortion Induced Anal Atresia Anomaly Of External Ear Congenital Complications Of Maternal Exposure To Therapeutic Drugs Congenital Anomaly Congenital Eye Disorder Congenital Genitourinary Abnormality Facial Dysmorphism Fallot'S Tetralogy Gastrointestinal Disorder Congenital Infarction 24-Jun-2005 12:19 PM Page: 1942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maternal Drugs Affecting Foetus Microgenia Report Source Product Role Manufacturer Route Dose Duration Multiple Congenital Foreign Zyprexa-Oral Abnormalities Health (Olanzapine) Oligohydramnios Professional (Olanzapine) PS Placental Disorder Other Anafranil Placental Necrosis (Clomipramine Pulmonary Hypoplasia Hydrochloride) C Renal Disorder Therlalene Thrombosis (Alimemazine Tartrate) C Depamide (Valpromide) C Date:06/25/02ISR Number: 3939629-3Report Type:Expedited (15-DaCompany Report #FR_020601077 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa-Oral Dysphagia Health (Olanzapine) Professional (Olanzapine) PS 25 MG/DAY Other Date:06/25/02ISR Number: 3939630-XReport Type:Expedited (15-DaCompany Report #FR_020601092 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Zyprexa-Oral Pneumonia Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Date:06/25/02ISR Number: 3939634-7Report Type:Expedited (15-DaCompany Report #EWC020631342 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Olanzapine-Oral Initial or Prolonged Concussion Health (Olanzapine) PS 12.5 MG/DAY Contusion Professional Temesta (Lorazepam) C Drug Interaction Other Quilonorm (Lithium Drug Level Increased Acetate) C Fall Eltroxin Laceration (Levothyroxine Sodium) C Diovan (Valsartan) C Zyloric (Allopurinol) C Depakine Chrono C Akineton (Biperiden Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/02ISR Number: 3939636-0Report Type:Expedited (15-DaCompany Report #EWC020631330 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Foreign Zyprexa-Oral Initial or Prolonged Suicidal Ideation Health (Olanzapine) Suicide Attempt Professional (Olanzapine) PS 560 MG/DAY Other Gladem (Sertraline Hydrochloride) C Date:06/25/02ISR Number: 3939638-4Report Type:Expedited (15-DaCompany Report #EWC020530820 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ear Haemorrhage Foreign Zyprexa-Oral Life-Threatening Hyperglycaemic Health (Olanzapine) Hospitalization - Hyperosmolar Nonketotic Professional (Olanzapine) PS 25 MG 1 YR Initial or Prolonged Syndrome Company Zoloft (Sertraline Meningitis Representative Hydrochloride) C Neuroleptic Malignant Other Truxal Syndrome (Chlorprothixene Prescribed Overdose Hydrochloride) C Serotonin Syndrome Lomir (Isradipine) C Glucophage (Metformin Hydrochloride) C Rivotril (Clonazepam) C Date:06/25/02ISR Number: 3939700-6Report Type:Expedited (15-DaCompany Report #USA020616823 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa-Oral Initial or Prolonged Congestive Professional (Olanzapine) Cardiomegaly Company (Olanzapine) PS 20 MG/DAY Oedema Representative Ativan (Lorazepam) C Phytonadione C Date:06/25/02ISR Number: 3939701-8Report Type:Expedited (15-DaCompany Report #USA020616635 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa-Oral Initial or Prolonged Crying (Olanzapine) Delusion (Olanzapine) PS 10 MG/DAY Fear Zyprexa Paranoia Zydis-Dispersible (Olanzapine) (Olanzapine) SS 20 MG/DAY 10 WK Cogentin (Benzatropine Mesilate) C Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 1944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/02ISR Number: 3939702-XReport Type:Expedited (15-DaCompany Report #USA020617017 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Zyprexa-0ral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 2 YR Lithium C Tegretol (Carbamazepine) C Klonopin (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Date:06/25/02ISR Number: 3939713-4Report Type:Expedited (15-DaCompany Report #USA020617003 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG AT BEDTIME Date:06/25/02ISR Number: 3939714-6Report Type:Expedited (15-DaCompany Report #USA020616996 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 10 MG DAY Date:06/25/02ISR Number: 3939744-4Report Type:Expedited (15-DaCompany Report #US_020685139 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Zyprexa-Oral Gastrointestinal Professional (Olanzapine) Haemorrhage (Olanzapine) PS 10 MG/DAY Wellbutrin Sr (Amfebutamone Hydrochloride) C Date:06/25/02ISR Number: 3939928-5Report Type:Expedited (15-DaCompany Report #USA020616703 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersomnia Health Zyprexa-Oral Pyrexia Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Depakote (Valproate Semisodium) C Coumadin (Warfarin Sodium) C 24-Jun-2005 12:19 PM Page: 1945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/02ISR Number: 3939931-5Report Type:Expedited (15-DaCompany Report #USA020616746 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY Representative Date:06/25/02ISR Number: 3939934-0Report Type:Expedited (15-DaCompany Report #DE_990200875 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Foreign Zyprexa-Oral Initial or Prolonged Eosinophilia Literature (Olanzapine ) Euphoric Mood Health (Olanzapine) PS 22.5 MG/DAY Leukocytosis Professional Lorazepam C Medication Error Other Mental Disorder Prescribed Overdose Self Esteem Inflated Sleep Disorder White Blood Cell Count Increased Date:06/25/02ISR Number: 3939957-1Report Type:Expedited (15-DaCompany Report #CA_020605171 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Company Representative Other Date:06/25/02ISR Number: 3939967-4Report Type:Expedited (15-DaCompany Report #US_020584368 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acidosis Foreign Zyprexa-Oral Hospitalization - Arteritis Health (Olanzapine) PS ORAL 5 MG/DAY Initial or Prolonged Pyrexia Professional Vancomycin-Iv Other Status Epilepticus Company (Vancomycin) SS INTRAVENOUS 1000 MG/DAY Representative Barnetil Other (Sultopride) C Silece (Flunitrazepam) C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride) C Benzalin (Nitrazepam) C Iscotin (Isoniazid) C Baktar C Prednisolone C Dalacin (Clindamycin Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/02ISR Number: 3939969-8Report Type:Expedited (15-DaCompany Report #US_020685242 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Abnormal Foreign Zyprexa-Oral Obesity Health (Olanzapine) PS ORAL 20 MG/DAY Weight Decreased Professional Vegetamin A C Company Rohypnol Representative (Flunitrazepam) C Other Limas (Lithium Carbonate) C Zotepine C Linton (Haloperidol) C Tasmolin (Biperiden) C Date:06/25/02ISR Number: 3939975-3Report Type:Expedited (15-DaCompany Report #GBS020610853 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Zyprexa-Oral Neck Mass Health (Olanzapine) PS ORAL 5 MG/1 DAY Oedema Peripheral Professional Efexor (Venlafaxine Pitting Oedema Other Hydrochloride) C Date:06/25/02ISR Number: 3940024-1Report Type:Expedited (15-DaCompany Report #HQ294424JUN2002 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Temesta (Lorazepam, Abnormal Professional Unspec) PS ORAL SEE IMAGE 65 DAY Weight Increased Quilonorm Retard (Lithium Carbonate, ) SS SEE IMAGE 10 DAY Zyprexa (Olanzapine, ) SS SEE IMAGE 5 DAY Date:06/25/02ISR Number: 3940064-2Report Type:Expedited (15-DaCompany Report #US_020584425 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Zyprexa-Oral Abnormal Health (Olanzapine) Blood Triglycerides Professional (Olanzapine) PS 10 MG/DAY Abnormal Company Bezatol Sr Condition Aggravated Representative (Bezafibrate) C Diabetes Mellitus Other Risperdal Glucose Tolerance (Risperidone) C Impaired Linton (Haloperidol) C Glucose Urine Present Levotomin Glycosylated Haemoglobin (Levomepromazine Increased Maleate) C High Density Lipoprotein Lexin Abnormal (Carbamazepine) C Type I Hyperlipidaemia Akineton (Biperiden Hydrochloride) C Diazepam C Grimac C Promethazine C 24-Jun-2005 12:19 PM Page: 1947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/02ISR Number: 3940067-8Report Type:Expedited (15-DaCompany Report #US_020584697 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 5 MG/DAY Aminotransferase Company Increased Representative Blood Triglycerides Other Increased Cataplexy Diabetes Mellitus Gamma-Glutamyltransferase Increased Glycosylated Haemoglobin Increased Liver Function Test Abnormal Date:06/25/02ISR Number: 3940070-8Report Type:Expedited (15-DaCompany Report #US_020685125 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Zyprexa-Oral Ventricular Fibrillation Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Akineton (Biperiden Representative Hydrochloride) C Other Symmetrel (Amantadine Hydrochloride) C Quetiapine Fumarate C Dogmatyl (Sulpiride) C Date:06/25/02ISR Number: 3940076-9Report Type:Expedited (15-DaCompany Report #EWC020530850 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa-Oral Initial or Prolonged Dyspnoea Health (Olanzapine) Neuroleptic Malignant Professional (Olanzapine) PS 20 MG/DAY Syndrome Company Salivary Hypersecretion Representative Tremor Other Date:06/26/02ISR Number: 3940469-XReport Type:Direct Company Report #CTU 170966 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olanzapine PS ORAL 15MG BEDTIME Syndrome ORAL 24-Jun-2005 12:19 PM Page: 1948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/02ISR Number: 3940524-4Report Type:Direct Company Report #CTU 171173 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine PS ORAL PO 5 MG HS Date:06/27/02ISR Number: 3940689-4Report Type:Direct Company Report #CTU 171137 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Olanzapine 10mg Bid PS ORAL 10MG PO BID Niacin C Fluoxetine C Ascorbic Acid C Vit E C Ziprasidone C Date:06/27/02ISR Number: 3940691-2Report Type:Direct Company Report #CTU 171139 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Olanzapine -Lilly PS Lilly 30MG HS Weight Increased Valproic Acid SS Maxzide C Levothyroxine C ... C Amolodipine C Lipitor C Date:06/27/02ISR Number: 3940692-4Report Type:Direct Company Report #CTU 171141 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Olanzapine Tablets PS ORAL 10MG PO BID Date:06/27/02ISR Number: 3940693-6Report Type:Direct Company Report #CTU 171093 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Olanzapine 5 Mg Metabolic Acidosis Lilly PS Lilly HS Date:06/27/02ISR Number: 3940795-4Report Type:Direct Company Report #CTU 171069 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersomnia Olanzapine Tab PS 10 MG DAILY Parkinsonism Sedation Date:06/27/02ISR Number: 3940825-XReport Type:Expedited (15-DaCompany Report #USA020515251 Age:20 YR Gender:Male I/FU:F Outcome Death Life-Threatening 24-Jun-2005 12:19 PM Page: 1949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Health Zyprexa-Oral Increased Professional (Olanzapine) Blood Glucose Increased Company (Olanzapine) PS 15 MG DAY Blood Ph Decreased Representative Klonopin Blood Triglycerides (Clonazepam) C Increased Trazodone C Blood Urea Abnormal Risperdal Depressed Level Of (Risperidone) C Consciousness Haldol Decanoate Diabetic Ketoacidosis (Haloperidol Lethargy Decanoate) C Respiratory Failure Somnolence Urine Ketone Body Present Weight Increased Date:06/27/02ISR Number: 3941358-7Report Type:Expedited (15-DaCompany Report #US_020484095 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abulia Foreign Zyprexa-Oral Hospitalization - Adjustment Disorder Health (Olanzapine) Initial or Prolonged Communication Disorder Professional (Olanzapine) PS 10 MG/DAY Completed Suicide Company Humulin-Human Nph Decreased Appetite Representative Insulin (Rdna) Depression Other (Human Insulin (Rd SS Diabetic Retinopathy Glucobay(Acarbose) C Drowning Tetramide (Mianserin Dyskinesia Hydrochloride) C Gait Disturbance Eurodin(Estazolam) C Humerus Fracture Lendormin Negativism (Brotizolam) C Neuropathy Peripheral Psychiatric Symptom Suicidal Ideation Suicide Attempt Vitreous Haemorrhage Date:06/27/02ISR Number: 3984120-1Report Type:Periodic Company Report #WAES 0205USA00585 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Tab Vioxx 25 Mg PS ORAL 25 Drug Level Increased Professional MG/DAILY/PO Extrapyramidal Disorder Clozapine SS Olanzapine SS Biaxin C Phenergan With Codeine C 24-Jun-2005 12:19 PM Page: 1950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/02ISR Number: 3941503-3Report Type:Direct Company Report #CTU 171232 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Chloride Decreased Olanzapine PS ORAL 40 MG PO QD 1 MON Hospitalization - Blood Creatine Vit B12 C Initial or Prolonged Phosphokinase Increased Gatifloxacin C Blood Glucose Increased Prednisone C Blood Potassium Increased Darvocet C Blood Sodium Decreased Salmeterol C Dyspnoea Imuran C Myalgia Colace C Renal Impairment Ativan C Rhabdomyolysis Gabapentin C Combivent C Tylox C Heparin C Solucortef C Depakene C Vasotec C Bactrim C Lopressor Xl C Zofran C Folic Acid C Asa C Nexium C Date:06/28/02ISR Number: 3941950-XReport Type:Expedited (15-DaCompany Report #GBS020510712 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Blepharitis Consumer (Olanzapine)(Alanzap Bradykinesia Health ine) PS 10 MG/DAY Cellulitis Orbital Professional Priadel (Lithium Condition Aggravated Other Carbonate) C Diarrhoea Zopiclone C Extrapyramidal Disorder Temazepam C Faecal Incontinence Faeces Discoloured Gastrooesophageal Reflux Disease Hepatitis B Hyperhidrosis Ill-Defined Disorder Insomnia Joint Swelling Malaise Musculoskeletal Stiffness Nausea Oedema Peripheral Pain Salivary Hypersecretion Skin Inflammation Urinary Incontinence Varicose Vein Weight Increased 24-Jun-2005 12:19 PM Page: 1951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/02ISR Number: 3941951-1Report Type:Expedited (15-DaCompany Report #USA020515144 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Zyprexa-Oral Hospitalization - Infarction Professional (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Cardiac Failure Company Dilantin (Phenytoin Congestive Representative Sodium) C Lasix (Fuurosemide) C K-Dur (Potassium Chloride) C Altace (Ramipril) C Aldactone (Spironolactone) C Date:06/28/02ISR Number: 3941955-9Report Type:Expedited (15-DaCompany Report #US_020584724 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Olanzapine-Oral Completed Suicide Study (Olanzapine) PS 15 MG DAY Drowning Health Wypax (Lorazepam) C Professional Silece Other (Flunitrazepam) C Actos (Pioglitazone) C Levotomin (Levomepromazine Maleate) C Date:06/28/02ISR Number: 3941970-5Report Type:Expedited (15-DaCompany Report #EWC020631178 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxic Encephalopathy Foreign Olanzapine-Oral Life-Threatening Atrophy Health (Olanzapine) PS 10 MG/DAY Hospitalization - Brain Oedema Professional Dopamine Agonist C Initial or Prolonged Coma Other Complex Partial Seizures Confusional State Encephalitis Date:06/28/02ISR Number: 3941972-9Report Type:Expedited (15-DaCompany Report #GBS020510638 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zyprexa-Oral Initial or Prolonged Jaundice Health (Olanzapine)(Olanzap Liver Function Test Professional ine) PS 10MG /DAY Abnormal Other Largactil (Chlorpromazine Hydrochloride) C Seroxat(Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/02ISR Number: 3941977-8Report Type:Expedited (15-DaCompany Report #US_020684888 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Zyprexa-Oral Other Dialysis Health (Olanzapine)(Olanzap Loss Of Consciousness Professional ine) PS 10 MG/DAY Mental Disorder Company Artane Overdose Representative (Trihexyphenidyl Pneumonia Aspiration Other Hydrochloride) C Renal Failure Rohypnol Rhabdomyolysis (Flunitrazepam) C Suicide Attempt Vomiting Date:06/28/02ISR Number: 3941980-8Report Type:Expedited (15-DaCompany Report #US_020684963 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa-Oral Initial or Prolonged Gastrointestinal Health (Olanzapine)(Olanzap Haemorrhage Professional ine) PS 10 MG/DAY Company Levotomin Representative (Levomepromazine Other Maleate) C Rivotril (Clonazepam) C Metoclol (Metoclopramide) C Primperan(Metoclopra mide) C Wypax(Lorazepam) C Lendormin(Brotizolam ) C Rohypnol (Flunitrazepam) C Date:06/28/02ISR Number: 3941982-1Report Type:Expedited (15-DaCompany Report #EWC010526709 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 1 MON Initial or Prolonged Exposure To Therapeutic Health Cisordinol Drugs Professional (Clopenthixol Maternal Drugs Affecting Company Hydrochloride) C Foetus Representative Disipal Premature Baby Other (Orphenadrine Psychotic Disorder Hydrochloride) C Date:07/01/02ISR Number: 3942397-2Report Type:Direct Company Report #CTU 171381 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Ibuprofen PS ORAL 12 TABS PO Initial or Prolonged Somnolence EACH X 1 DOSE Required Toxicologic Test Abnormal Paroxetine SS Intervention to Olanzapine SS Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 1953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3943469-9Report Type:Expedited (15-DaCompany Report #EMADSS2002003882 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Haldol (Injection) Initial or Prolonged Hepatic Steatosis Health (Haloperidol) PS INTRAMUSCULAR SEE IMAGE Hepatitis Professional Zyprexa (Olanzapine) SS ORAL SEE IMAGE Rhabdomyolysis Glianimon Schizophrenia, Paranoid (Benperidol) SS ORAL SEE IMAGE Type Dociton (Propranol-Ol Hydrochloride) C Akineton (Biperiden Hydrochloride) C Atropinsulfat (Trospium Chloride) C Quilonum (Lithium Acetate) C Orfiril (Valproate Sodium) C Tavor (Lorazepam) C Date:07/01/02ISR Number: 3952767-4Report Type:Periodic Company Report #US_000847178 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Consumer Humulin-Human Initial or Prolonged Blood Glucose Increased Insulin (Rdna): 30% Infection Regular, 70% Nph (H PS 60 U/2 DAY Pruritus Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Humulin-Human Ultralente Insulin (Rdna) (Human Insu SS 10 U/1 DAY Humalog- (Lispro) SS Zyprexa (Olanzaprine) SS 10 MG/ 1 AT BEDTIME Haldol Decanoate (Haloperidol Decanoate) C Klonopin (Clonazepam) C Diphenhydramine C Hydroxyzine C Date:07/02/02ISR Number: 3943539-5Report Type:Direct Company Report #CTU 171529 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Increased Zyprexa PS ORAL 5 MG 4 MON Depakote C Asa C Neurontin C Prednisone C Lasix C 24-Jun-2005 12:19 PM Page: 1954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/02ISR Number: 3943574-7Report Type:Expedited (15-DaCompany Report #EWC020631303 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Abdomen Foreign Olanzapine-Oral Initial or Prolonged Blood Cholesterol Health (Olanzapine) PS 15 MG/DAY Increased Professional Lithium C Blood Triglycerides Company Fluoxetine C Decreased Representative Malaise Other Pancreatic Pseudocyst Pancreatitis Weight Increased Date:07/02/02ISR Number: 3943585-1Report Type:Expedited (15-DaCompany Report #DE_011207615 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Date:07/02/02ISR Number: 3943614-5Report Type:Expedited (15-DaCompany Report #US_020685125 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Zyprexa-Oral Ileus Paralytic Health (Olanzapine) Ventricular Fibrillation Professional (Olanzapine) PS 20 MG DAY Company Akineton (Biperiden Representative Hydrochloride) C Other Symmetrel (Amantadine Hydrochloride) C Quetiapine Fumarate C Dogmatyl (Sulpiride) C Date:07/02/02ISR Number: 3943633-9Report Type:Expedited (15-DaCompany Report #US_020584368 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acidosis Foreign Zyprexa-Oral Hospitalization - General Physical Health Health (Olanzapine) Initial or Prolonged Deterioration Professional (Olanzapine) PS 5 MG/DAY Other Inflammation Company Vancomycin-Iv Pneumonia Representative (Vancomycin) Pyrexia Other (Vancomycin Status Epilepticus Hydrochlorid SS 100 MG/DAY Barnetil (Sultopride) C Silece (Flunitrazepam) C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride) C Benzalin (Nitrazepam) C 24-Jun-2005 12:19 PM Page: 1955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Iscotin (Isoniazid)C C Baktar C Prednisolone C Dalacin (Clindamycin Hydrochloride) C Endoxan (Cyclophosphamide) C Date:07/02/02ISR Number: 3943636-4Report Type:Expedited (15-DaCompany Report #FR_020100599 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Zyprexa-Oral Hepatocellular Damage Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Anafranil Representative (Clomipramine Other Hydrochloride) C Date:07/03/02ISR Number: 3944258-1Report Type:Expedited (15-DaCompany Report #US_020685375 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Platelet Count Decreased Study (Olanzapine) PS 25 MG DAY Tremor Health Perospirone Hcl Professional Hydrate "Lullan" C Amoban (Zopiclone) C Orap (Pimozide) C Depas (Etizolam) C Date:07/03/02ISR Number: 3944260-XReport Type:Expedited (15-DaCompany Report #GBS020610896 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Other Gliclazide C Aspirin C Temazepam C Date:07/03/02ISR Number: 3944264-7Report Type:Expedited (15-DaCompany Report #US_020383049 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Amylase Increased Foreign Zyprexa-Oral Hospitalization - Neuroleptic Malignant Health (Olanzapine) Initial or Prolonged Syndrome Professional (Olanzapine) PS 20 MG/DAY Overdose Company Benzalin Representative (Nitrazepam) C Other Lendormin (Brotizolam) C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride C 24-Jun-2005 12:19 PM Page: 1956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/02ISR Number: 3944267-2Report Type:Expedited (15-DaCompany Report #HQ2925324JUN2002 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Increased Health Temesta (Lorazepam, Initial or Prolonged Blood Glucose Increased Professional Tablet) PS ORAL SEE IMAGE 1 DAY Circulatory Collapse Depakine Chrono Drug Interaction (Valproate Drug Level Below Sodium/Valproic Therapeutic Acid) SS SEE IMAGE 2 DAY Fall Quilonorm (Lithium Haematocrit Decreased Acetate) SS Haemoglobin Decreased Zyprexa (Olanzapine) SS SEE IMAGE 12 DAY Laceration Eltroxin Red Blood Cell Count (Levothyroxine Decreased Sodium) C Diovan (Valsartan) C Zyloric (Allopurinol0 C Akineton (Biperiden Hydrochloride) C Date:07/03/02ISR Number: 3944455-5Report Type:Expedited (15-DaCompany Report #EWC020631462 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Olanzapine-Oral Hospitalization - Myocarditis Health (Olanzapine) PS Initial or Prolonged Professional Company Representative Other Date:07/03/02ISR Number: 3944840-1Report Type:Expedited (15-DaCompany Report #USA020211263 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Consumer Zyprexa-Oral Initial or Prolonged Dystonia (Olanzapine) PS 40 MG/DAY Other Electrolyte Imbalance Zyprexa Glucose Tolerance Zydis-Dispersible Impaired (Olanzapine) SS 20 MG/2 DAY Heart Rate Decreased Depakote (Valproate Neuroleptic Malignant Semisodium) C Syndrome Parkinsonian Gait Scoliosis Tic Tongue Disorder Weight Increased Date:07/03/02ISR Number: 3944909-1Report Type:Expedited (15-DaCompany Report #US008746 Age:42 YR Gender:Male I/FU:F Outcome PT Hospitalization - Atelectasis Initial or Prolonged Bipolar Disorder Coma Delusion 24-Jun-2005 12:19 PM Page: 1957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Electrocardiogram T Wave Abnormal Report Source Product Role Manufacturer Route Dose Duration Hypomania Health Provigil PS ORAL 200 MG QD Mania Professional ORAL Overdose Provigil SS Psychotic Disorder Wellbutrin SS ORAL 6 TAB ONCE Suicidal Ideation ORAL Wellbutrin SS ORAL 200 MG QD ORAL Zyprexa SS Lithium C Date:07/03/02ISR Number: 3944949-2Report Type:Expedited (15-DaCompany Report #2002UW01819 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Seroquel "Zeneca" PS "Zeneca" ORAL 800 MG DAILY Hepatic Steatosis Professional PO Ill-Defined Disorder Olanzapine SS Overdose Effexor SS Treatment Noncompliance Medication For Hypertension SS Date:07/03/02ISR Number: 3944967-4Report Type:Expedited (15-DaCompany Report #EWC010526709 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Maternal Drugs Affecting Foreign Zyprexa(Olanzapine) PS 10 MG/DAY 1 MON Initial or Prolonged Foetus Health Cisordinol Premature Baby Professional (Clopenthixol Psychotic Disorder Company Hydrochloride) C Representative Dispal (Orphenadrine Other Hydrochloride) C Date:07/03/02ISR Number: 3945074-7Report Type:Expedited (15-DaCompany Report #US_020685308 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Foreign Zyprexa-Oral Other Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Serenace Representative (Haloperidol) C Other Barnetil (Sultopride) C Date:07/08/02ISR Number: 3944719-5Report Type:Direct Company Report #CTU 171680 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Zyprexa PS 2 TABS QHS Intervention to Syndrome Unasyn C Prevent Permanent Morphine Drip C Impairment/Damage Ativan C Thiamine C Folic Acid C 24-Jun-2005 12:19 PM Page: 1958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pepcid C Date:07/08/02ISR Number: 3945022-XReport Type:Direct Company Report #CTU 171700 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa 15 Mg PS ORAL 15 MG PO HS Hospitalization - Diabetic Ketoacidosis Depakote C Initial or Prolonged Dyspnoea Stelazine C Hyperhidrosis Hyperventilation Mental Status Changes Date:07/08/02ISR Number: 3945652-5Report Type:Expedited (15-DaCompany Report #PHBS2002CH07403 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Diovan(Valsartan) Initial or Prolonged Laceration Health Unknown PS ORAL 80 MG/DAY, Shock Professional ORAL Other Zyprexa(Olanzapine) SS ORAL 10 & 2 MG/DAY, ORAL Temesta(Lorazepam) SS ORAL 3.5 MG/DAY, ORAL Quilonoram Retard C El Troxin C Zyloric "Glaxo Wellcome" C Depakine C Akineton (Biperiden Hydrochloride) C Date:07/09/02ISR Number: 3945448-4Report Type:Direct Company Report #CTU 171899 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Zyprexa 2.5mg Tablets Baker PS Baker ONE TABLET AT BEDTIME Zyprexa 2.5mg Tablets Baker SS Baker Date:07/09/02ISR Number: 3945750-6Report Type:Direct Company Report #CTU 171805 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Zyprexa 2.5mg Eli Hospitalization - Lilly PS Eli Lilly PARENTERAL 2.5MG BID Initial or Prolonged PARENTERAL Effexor C 24-Jun-2005 12:19 PM Page: 1959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3945925-6Report Type:Direct Company Report #CTU 171926 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperventilation Olanzapine (Zyprexa Neuroleptic Malignant (R)) - Eli Lilly PS Eli Lilly 10 MG Q 6-8 Syndrome HR PRN Screaming Haloperidol SS INTRAMUSCULAR TOTAL OF 15MG IM/IV - 1-2MG Q6 HR ON 3/22 & 3/24 Pseudoephedrine C Prazosin C Trazadone C Olanzapine C Mirtazipine C Clonazepam C Silenafil C Kava Kava Root C Date:07/09/02ISR Number: 3946915-XReport Type:Expedited (15-DaCompany Report #US_020685406 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Maternal Drugs Affecting Health Zyprexa-Oral Initial or Prolonged Foetus Professional (Olanzapine) Neonatal Aspiration (Olanzapine) PS Neonatal Disorder Pregnancy Date:07/09/02ISR Number: 3946916-1Report Type:Expedited (15-DaCompany Report #USA020617296 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS ORAL Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS ORAL Date:07/09/02ISR Number: 3946925-2Report Type:Expedited (15-DaCompany Report #USA020617353 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:07/09/02ISR Number: 3946926-4Report Type:Expedited (15-DaCompany Report #USA020617482 Age:46 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Arthralgia Blood Albumin Decreased Blood Amylase Increased 24-Jun-2005 12:19 PM Page: 1960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Copper Increased Cyanosis Headache Report Source Product Role Manufacturer Route Dose Duration Malnutrition Consumer Zyprexa-Oral Myalgia (Olanzapine) Pallor (Olanzapine) PS 15 MG/DAY 11 WK Protein Total Decreased Celebrex (Celecoxib) C Pyrexia Premarin (Estrogens Weight Increased Conjugated) C Xanax (Alprazolam) C Risperdal (Risperidone) C Effexor (Venlafaxine Hydrochloride) C Klonopin (Clonazepam) C Zyrtec (Cetirizine Hydrochloride) C Trinsicon C Omega-3 Fatty Acids (Omega-3 Triglycerides) C Malic Acid C Date:07/09/02ISR Number: 3946927-6Report Type:Expedited (15-DaCompany Report #USA020617487 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 3 DAY Representative Thorazine (Chlorpromazine Hydrochloride) C Date:07/09/02ISR Number: 3946928-8Report Type:Expedited (15-DaCompany Report #USA020617533 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Zyprexa-Oral Initial or Prolonged Gastrointestinal Disorder Professional (Olanzapine) Company (Olanzapine) PS Representative Date:07/09/02ISR Number: 3947080-5Report Type:Expedited (15-DaCompany Report #US_020684898 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glycosylated Haemoglobin Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Polydipsia Professional (Olanzapine) PS 10 MG/DAY Polyuria Company Risperdal Representative (Risperidone) C Other Akineton(Biperiden Hydrochloride) C Bromperidol C Artane(Trihexyphenid yl Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Silece (Flunitrazepam) C Dalmate (Flurazepam Hydrochloride) C Neuleptil (Periciazine) C Gasmotin (Mosapride Citrate) C Date:07/09/02ISR Number: 3947098-2Report Type:Expedited (15-DaCompany Report #EWC020631524 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa-Oral Intentional Self-Injury Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Panangin C Representative Medazepam C Other Colfarit (Acetylsalicylic Acid) C Inderal (Propranolol Hydrochloride) C Date:07/09/02ISR Number: 3947099-4Report Type:Expedited (15-DaCompany Report #EWC020731615 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lichen Planus Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 7.5 MG/1 DAY Professional Enalapril Maleate C Other Propranolol Hydrochloride C Thyroxine Sodium C Vitamin B Substances C Oxazepam C Date:07/09/02ISR Number: 3947100-8Report Type:Expedited (15-DaCompany Report #DE_020608994 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Zyprexa-Oral Hospitalization - Complete Health (Olanzapine) Initial or Prolonged Coma Professional (Olanzapine) PS 7.5 MG/DAY Coronary Artery Disease Other Stangyl (Trimipramine Maleate) C Anafranil (Clomipramine Hydrochloride) C Thyreotom C None C 24-Jun-2005 12:19 PM Page: 1962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3947107-0Report Type:Expedited (15-DaCompany Report #DE_020609017 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Date:07/09/02ISR Number: 3947108-2Report Type:Expedited (15-DaCompany Report #EWC020631509 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Maternal Drugs Affecting Foreign Olanzapine-Oral Initial or Prolonged Foetus Health (Olanzapine) PS Neonatal Respiratory Professional Distress Syndrome Other Date:07/09/02ISR Number: 3947114-8Report Type:Expedited (15-DaCompany Report #USA020413705 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Health Zyprexa-Oral Completed Suicide Professional (Olanzapine) Overdose Company (Olanzapine) PS 25 MG/DAY Pancreatic Haemorrhage Representative Depakote(Valproate Semisodium) C Luvox (Fluvoxamine Maleate) C Date:07/09/02ISR Number: 3947115-XReport Type:Expedited (15-DaCompany Report #USA020516368 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Acute Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Oscal 500-D C Centrum Silver C Tylenol (Paracetamol) C Date:07/09/02ISR Number: 3947119-7Report Type:Expedited (15-DaCompany Report #US_990319499 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Diabetes Mellitus Inadequate Control Feeling Abnormal Injection Site Reaction Localised Infection Obsessive-Compulsive Disorder Postoperative Infection Skin Ulcer Somnolence Staphylococcal Infection 24-Jun-2005 12:19 PM Page: 1963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toe Amputation Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Consumer Humulin-Humulin Lente PS 38 U/DAY Humulin-Human Regular Insulin SS Iletin-Insulin-Anima l SS Zyprexa-Oral (Olanzapine) SS 2.5 MG/DAY Humalog-. (Lispro) SS 28 U/DAY Klonopin (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Date:07/09/02ISR Number: 3947131-8Report Type:Expedited (15-DaCompany Report #USA020717840 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Physical Assault Health Zyprexa-Oral Psychotic Disorder Professional (Olanzapine) (Olanzapine) PS 60 MG/DAY Date:07/09/02ISR Number: 3947133-1Report Type:Expedited (15-DaCompany Report #US_010259053 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Zyprexa-Oral Initial or Prolonged Anxiety (Olanzapine)(Olanzap Constipation ine) PS 5 MG/DAY 3 YR Dizziness Drug Ineffective Headache Hypothyroidism Influenza Like Illness Insomnia Nausea Suicidal Ideation Date:07/09/02ISR Number: 3947134-3Report Type:Expedited (15-DaCompany Report #US_010872440 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Consumer Zyprexa-Oral Initial or Prolonged Exposure To Therapeutic Health (Olanzapine)(Olanzap Drugs Professional ine) PS 20 MG/DAY Malaise Depakoe (Valproate Premature Labour Semisodium) C Vomiting Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 1964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3947150-1Report Type:Expedited (15-DaCompany Report #US_020685296 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Nizatidine Non-Insulin-Dependent Health (Nizatidine) PS 150 MG/2 DAY Weight Decreased Professional Olanzapine-Oral (Olanzapine) SS 15 MG/AT BEDTIME Haloperidol Decanoate C Divalproex Sodium C Lorazepam C Levothyroxine C Date:07/09/02ISR Number: 3947157-4Report Type:Expedited (15-DaCompany Report #USA020617706 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Prozac-Oral Toxicologic Test Abnormal Professional (Fluoxetine) Company (Fluoxetine Representative Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG/DAY Haldol Decanoate (Haloperidol Decanoate) C Date:07/09/02ISR Number: 3947249-XReport Type:Expedited (15-DaCompany Report #B0271873A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Requip Tablet Initial or Prolonged Hallucination, Visual (Ropinirole Hcl) PS ORAL ORAL Persecutory Delusion Olanzapine (Formulation Unknown) (Olanzapine) SS Modopar C Lorazepam C Citalopram Hydrobromide C Date:07/09/02ISR Number: 3947643-7Report Type:Expedited (15-DaCompany Report #EWC020530820 Age:52 YR Gender:Female I/FU:F Outcome PT Death Agitation Life-Threatening Depressed Level Of Hospitalization - Consciousness Initial or Prolonged Diabetes Mellitus Ear Haemorrhage Hyperglycaemic Hyperosmolar Nonketotic Syndrome Hyperpyrexia Infection 24-Jun-2005 12:19 PM Page: 1965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Meningitis Herpes Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pneumonia Foreign Zyprexa-Oral Prescribed Overdose Health (Olanzapine) Rhabdomyolysis Professional (Olanzapine) PS 25 MG 1 YR Serotonin Syndrome Company Zoloft (Sertraline Representative Hydrochloride) C Other Truxal (Chlorprothixene Hydrochloride) C Lomir (Isadipine) C Glucophage(Metformin Hydrochloride) C Rivotril (Clonazepam) C Date:07/09/02ISR Number: 3947644-9Report Type:Expedited (15-DaCompany Report #EWC020631330 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Foreign Zyprexa Oral Initial or Prolonged Confusional State Health (Olanzapine) Memory Impairment Professional (Olanzapine) PS 560 MG/DAY Micturition Disorder Other Gladem (Sertraline Sinus Tachycardia Hydrochloride) C Suicide Attempt Date:07/09/02ISR Number: 3947645-0Report Type:Expedited (15-DaCompany Report #EWC020631462 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Olanzapine Hospitalization - Health (Olanzapine) PS 10 MG Initial or Prolonged Professional Fevarin (Fluvoxamine Company Maleate) C Representative Date:07/09/02ISR Number: 3947646-2Report Type:Expedited (15-DaCompany Report #AU_020204700 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zypexa-Oral Overdose Health (Olanzapine) Professional (Olanzapine) PS Company Citalopram C Representative Diazepam C Other Date:07/09/02ISR Number: 3947647-4Report Type:Expedited (15-DaCompany Report #DE_020408396 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Zyprexa-Oral Initial or Prolonged Colitis Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Aequamen 24-Jun-2005 12:19 PM Page: 1966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Betahistine Mesilate) C Date:07/09/02ISR Number: 3947654-1Report Type:Expedited (15-DaCompany Report #US_020483713 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Oral Hospitalization - Infarction Health (Olanzapine) Initial or Prolonged Arrhythmia Professional (Olanzapine) PS 5 MG/DAY Other Aspartate Company Blopress Aminotransferase Representative (Candesartan Increased Cilexetil) C Blood Creatine Harnal (Tamsulozin Phosphokinase Increased Hydrochloride) C Blood Lactate Prostatic Dehydrogenase Increased Hypertrophy C Cardiac Failure Norvasc (Amlodipine Cardio-Respiratory Arrest Besilate) C Diabetes Mellitus Glimicron Sudden Death (Gliclazide) C Ventricular Hypertrophy Persantin (Dipyridamole) C Date:07/09/02ISR Number: 3947655-3Report Type:Expedited (15-DaCompany Report #US_020685308 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa-Oral Other Abnormal Behaviour Health (Olanzapine) Anuria Professional (Olanzapine) PS 10 MG/DAY Blood Glucose Increased Company Serenace Cardiac Failure Acute Representative (Haloperidol) C Cardio-Respiratory Arrest Other Barnetil Chest X-Ray Abnormal (Sultopride) C Circulatory Collapse Zotepine C Convulsion Propericiazine Electrocardiogram Qt (Periciazine) C Prolonged Biperiden C Ileus Paralytic Vegetamin B C Pallor Flunitrazepam C Pulse Absent Levopromazine C Pupillary Reflex Impaired Lipovas (Fenofibrate) C Date:07/09/02ISR Number: 3947656-5Report Type:Expedited (15-DaCompany Report #FR_020601077 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa-Oral Prescribed Overdose Health (Olanzapine) Professional (Olanzapine) PS 25 MG/DAY Other 24-Jun-2005 12:19 PM Page: 1967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3947662-0Report Type:Expedited (15-DaCompany Report #US_020685227 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Other Mydriasis Health (Olanzapine) Professional (Olanzapine) PS 10MG/DAY Company Seroquel C Representative Serenace Other (Haloperidol) C Chlorpromazine C Hirnamin (Levomepromazine) C Barnetil (Sultopride) C Tegretol (Carbamazepine) C Benzalin (Nitrazepam) C Pyrethia (Promethazine Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Date:07/09/02ISR Number: 3947663-2Report Type:Expedited (15-DaCompany Report #US_020685237 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Hospitalization - Mental Disorder Health (Olanzapine) Initial or Prolonged Refusal Of Treatment By Professional (Olanzapine) PS 15 MG/DAY Patient Company Chlorpromazine C Representative Haloperidol C Other Hirnamin (Levomepromazine) C Depas (Etizolam) C Pyrethia (Promethazine Hydrochloride) C Rohypnol (Flunitrazepam) C Artane (Trihexyphenidyl Hydrochloride) C Date:07/09/02ISR Number: 3947664-4Report Type:Expedited (15-DaCompany Report #US_020785540 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Labyrinthitis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Other 24-Jun-2005 12:19 PM Page: 1968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3947665-6Report Type:Expedited (15-DaCompany Report #US_020684963 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) Renal Cyst Professional (Olanzapine) PS 10 MG/DAY Company Levotomin Representative (Levomepromazine Other Maleate) C Rivotril (Clonazepam) C Metoclol (Metoclopramide) C Primperan (Metoclopramide) C Wypax (Lorazepam) C Lendormin (Brotizolam) C Rohypnol (Flunitrazepam) C Date:07/10/02ISR Number: 3946277-8Report Type:Direct Company Report #CTU 172071 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Cholesterol Olanzapine PS 10 MG BID PO Intervention to Increased Sinemet C Prevent Permanent Blood Glucose Increased Glucophage C Impairment/Damage Blood Triglycerides Glucotrol C Increased Zocor C Glycosylated Haemoglobin Proventil Inhaler C Increased Date:07/10/02ISR Number: 3946366-8Report Type:Direct Company Report #CTU 171941 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Olanzepine 2.5 Mg Initial or Prolonged Consciousness And 5 Mg PS 5 MG QHS Drooling Azithromycin C Somnolence Valproic Acid C Guanfacine C Date:07/10/02ISR Number: 3946369-3Report Type:Direct Company Report #CTU 171943 Age:21 YR Gender:Female I/FU:I Outcome PT Hospitalization - Caesarean Section Initial or Prolonged Complications Of Maternal Required Exposure To Therapeutic Intervention to Drugs Prevent Permanent Foetal Disorder Impairment/Damage Foetal Heart Rate Decreased Foetal Heart Rate Increased Foetal Movements Decreased 24-Jun-2005 12:19 PM Page: 1969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maternal Drugs Affecting Foetus Neonatal Respiratory Report Source Product Role Manufacturer Route Dose Duration Distress Syndrome Zyprexa 5mg Qd Eli Premature Baby Lilly PS Eli Lilly 5MG QD Tachycardia Prozac C Iron C Date:07/10/02ISR Number: 3947829-1Report Type:Expedited (15-DaCompany Report #A213033 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blister Foreign Ziprasidone Intervention to Infection Health (Ziprasidone) PS ORAL 6 GRAM, ORAL Prevent Permanent Sensory Disturbance Professional Zyprexa (Olanzapine) SS 75 MG Impairment/Damage Suicide Attempt Company Tavor (Lorazepam) SS Urticaria Representative Date:07/10/02ISR Number: 3949723-9Report Type:Expedited (15-DaCompany Report #D0038587A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Eskalith Tablet- Initial or Prolonged Haemodialysis Health Controlled Release PS ORAL 60 TABLET/ Other Intentional Misuse Professional SINGLE DOSE/ Required Polyuria ORAL Intervention to Somnolence Olanzapine Tablet Prevent Permanent Suicide Attempt (Olanzapine) SS ORAL 27 TABLET / Impairment/Damage SINGLE DOSE/ ORAL Date:07/11/02ISR Number: 3946832-5Report Type:Direct Company Report #CTU 172106 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Zyprexa PS ORAL PO Neuroleptic Malignant Prozac SS ORAL PO Syndrome Trazodone SS ORAL PO Pulse Absent Sonata SS ORAL PO Respiratory Failure Date:07/11/02ISR Number: 3948992-9Report Type:Expedited (15-DaCompany Report #S02-AUS-01353-01 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Cipramil (Citalopram Overdose Health Hydrobromide) PS Professional Cipramil (Citalopram Other Hydrobromide) SS ORAL 20 MG QD PO Diazepam SS Diazepam SS ORAL 2 MG PRN PO Olanzapine (Olanzapine) SS ORAL 20 MG QD PO Olanzapine (Olanzapine) SS ORAL 20 MG QD PO 24-Jun-2005 12:19 PM Page: 1970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/02ISR Number: 3947491-8Report Type:Direct Company Report #CTU 172194 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Zyprexa 10 Mg PS ORAL 10 MG PO QD Intervention to Depakote C Prevent Permanent Impairment/Damage Date:07/12/02ISR Number: 3949056-0Report Type:Expedited (15-DaCompany Report #USA-2002-0001521 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Adrenal Adenoma Professional Hydrochloride Arteriosclerosis (Similar To Nda Atherosclerosis 20-553) (Oxycodone Bronchiolitis Hydrochloride) PS MG Cardiomegaly Olanzapine Coma (Olanzapine) SS MG Contusion Paroxetine Drug Toxicity Hydrochloride Emphysema (Paroxetine Excoriation Hydrochloride) SS MG Hepatic Steatosis Dextromethorphan Injury (Dextromethorphan) SS MG Mucosal Erosion Pallor Somnolence Toxicologic Test Abnormal Vomiting Date:07/12/02ISR Number: 3950426-5Report Type:Expedited (15-DaCompany Report #D0038633A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Eskalith Initial or Prolonged Dysarthria Health Tablet-Controlled Enuresis Professional Release (Lithium Faecal Incontinence Carbonate) PS ORAL 90 TABLET/ Haemodialysis SINGLE DOSE/ Intentional Misuse ORAL Somnolence Olanzapine Tablet Suicide Attempt (Olanzapine) SS ORAL 20 TABLET/ Vomiting SINGLE DOSE/ ORAL Citalopram Tablet (Citalopram) SS ORAL 20 TABLET/ SINGLE DOSE/ ORAL Thyroxine Sodium Tablet (Levothyroxine Sodium) SS ORAL 50 TABLET/ SINGLE DOSE/ ORAL Prothipendyl Hcl Tablet (Prothipendyl Hcl) SS ORAL 10 TABLET/ SINGLE DOSE/ 24-Jun-2005 12:19 PM Page: 1971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:07/15/02ISR Number: 3948154-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11735347 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Culture Positive Health Olanzapine PS ORAL Initial or Prolonged Erysipelas Professional Prednisone Acetate C 50 mg from 14 Disability Leukaemia Mar 02 to 27 Neutropenia Mar 02; 25 mg Streptococcal Infection from 28 Mar White Blood Cell Count 02 to 27 Jun Decreased Coversyl C Hctz C Losec C Neupogen C Cortisone C Date:07/15/02ISR Number: 3948586-5Report Type:Direct Company Report #CTU 172310 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Olanzepine 5 Mg Initial or Prolonged Lilly PS Lilly ORAL 15 MG QHS ORAL Phenytoin C Metoprolol C Lisinopril C Lansoprazole C Date:07/16/02ISR Number: 3949719-7Report Type:Expedited (15-DaCompany Report #DE_020709057 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Zyprexa-Oral Haemolytic Anaemia Health (Olanzapine) Hypotension Professional (Olanzapine) PS 10 MG/DAY Pyrexia Other Fluanxol Tachycardia (Flupentixol Dihydrochloride) C Tavor (Lorazepam) C Date:07/16/02ISR Number: 3949934-2Report Type:Expedited (15-DaCompany Report #US_020785624 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG DAY Company Tolopelon Representative (Timiperone) C Other 24-Jun-2005 12:19 PM Page: 1972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/02ISR Number: 3949936-6Report Type:Expedited (15-DaCompany Report #DE_020709062 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akinesia Foreign Zyprexa-Oral Hospitalization - Drug Toxicity Consumer (Olanzapine) Initial or Prolonged Heart Rate Decreased Other (Olanzapine) PS Hepatic Failure Hepatic Function Abnormal Date:07/16/02ISR Number: 3949938-XReport Type:Expedited (15-DaCompany Report #GBS020610940 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa-Oral Initial or Prolonged Delusion Consumer (Olanzapine) Disorientation Health (Olanzapine) PS Dysarthria Professional Carbamazepine C Hallucination Other Intentional Misuse Date:07/16/02ISR Number: 3949942-1Report Type:Expedited (15-DaCompany Report #GBS020710989 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Foreign Zyprexa-Oral Chorea Health (Olanzapine) Dyskinesia Professional (Olanzapine) PS 10 MG/DAY Dystonia Other Lorazepam C Oculogyration Diazepam C Dexamethasone C Haloperidol C Lansoprazole C Date:07/16/02ISR Number: 3950037-1Report Type:Expedited (15-DaCompany Report #USA020617799 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 10 MG Depakote (Valproate Semisodium) C Diazepam C Diphenhydramine C Neurontin (Gabapentin) C Date:07/16/02ISR Number: 3950038-3Report Type:Expedited (15-DaCompany Report #USA020617765 Age: Gender:Female I/FU:I Outcome PT Report Source Death Blood Glucose Increased Health Other Professional 24-Jun-2005 12:19 PM Page: 1973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/DAY Date:07/16/02ISR Number: 3950390-9Report Type:Expedited (15-DaCompany Report #USA020717948 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Health Zyrexa Hospitalization - Muscle Spasms Professional (Olanzapine) PS 15 MG/DAY Initial or Prolonged Pollakiuria Lithium C Other Thirst Date:07/16/02ISR Number: 3950391-0Report Type:Expedited (15-DaCompany Report #US_020785604 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Health Zyprexa-Oral Hyperkalaemia Professional (Olanzapine) PS ORAL 20 MG/DAY Hypotension Lisinopril C Hypothermia Thioridazine C Depakote (Valproate Semisodium) C Levothyroxine C Date:07/16/02ISR Number: 3950394-6Report Type:Expedited (15-DaCompany Report #USA020717888 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Macular Degeneration Consumer Zyprexa-Oral Ocular Vascular Disorder (Olanzapine) Visual Disturbance (Olanzapine) PS 2.5 MG/IN THE EVENING 5 MON Zoloft (Sertraline Hydrochloride) C Imipramine C Armour Thyroid (Thyroid) C Fosamax (Alendronate Sodium) C Date:07/17/02ISR Number: 3950430-7Report Type:Expedited (15-DaCompany Report #US_020584795 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Zyprexa-Oral Hepatic Function Abnormal Health (Olanzapine ) Hepatic Steatosis Professional (Olanzapine) PS 10 MG/DAY Company Silece(Flunitrazepam Representative ) C Other 24-Jun-2005 12:19 PM Page: 1974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/02ISR Number: 3950433-2Report Type:Expedited (15-DaCompany Report #US_020684963 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) Other Leukopenia Professional (Olanzapine) PS 10 MG/DAY Platelet Count Decreased Company Levotomin Renal Cyst Representative (Levomepromazine Other Maleate) C Rivotril (Clonazepam) C Metoclol(Metoclopram ide) C Primperan(Metoclopra mide) C Wypax(Lorazepam) C Lendormin (Brotizolam) C Rohypnol(Flunitrazep am) C Date:07/17/02ISR Number: 3950979-7Report Type:Expedited (15-DaCompany Report #USA020516020 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Zyprexa-Oral Other Diabetes Mellitus Professional (Olanzapine) Electrocardiogram Company (Olanzapine) PS 30 MG/DAY Abnormal Representative Zoloft (Sertraline Pulmonary Embolism Hydrochloride) C Weight Increased Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Topamax (Topiramate) C Date:07/17/02ISR Number: 3950980-3Report Type:Expedited (15-DaCompany Report #USA020616746 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Health Zyprexa-Oral Fatigue Professional (Olanzapine) Rhabdomyolysis Company (Olanzapine) PS ORAL 2.5 MG/DAY Representative Date:07/17/02ISR Number: 3950981-5Report Type:Expedited (15-DaCompany Report #US_020383011 Age:81 YR Gender:Female I/FU:F Outcome PT Other Abnormal Behaviour Agitation Anxiety Coma Confusional State Depressed Level Of Consciousness Depression Emotional Disorder 24-Jun-2005 12:19 PM Page: 1975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Hallucination Homicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa-Oral Hypervigilance Health (Olanzapine Immobile Professional (Olanzapine) PS 5 MG/DAY Incoherent Company Sinemet C Listless Representative Promazine C Mobility Decreased Requip (Ropinirole Mood Altered Hydrochloride) C Oral Intake Reduced Paranoia Sleep Disorder Speech Disorder Suicidal Ideation Transient Ischaemic Attack Waxy Flexibility Date:07/18/02ISR Number: 3950320-XReport Type:Direct Company Report #CTU 172509 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Olanzepine 7.5mg PS ORAL 7.5MG QD ORAL Initial or Prolonged Confusional State Pyrexia Tachycardia Date:07/18/02ISR Number: 3950634-3Report Type:Direct Company Report #CTU 172544 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Zyprexa 7.5mg Tablet PS Initial or Prolonged Tremor Oxycodone Required 5mg/Acetaminophen C Intervention to Nifedipine C Prevent Permanent Lisinopril C Impairment/Damage Doxazosin C Diphenhydramine C Acetaminophen C Lovastatin C Atenolol C Date:07/19/02ISR Number: 3951650-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU08140 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril (Clozapine) Completed Suicide Study Tablet PS ORAL 400 MG/DAY, Overdose Health ORAL Professional Olanzapine Other (Olanzapine) SS Haloperidol (Haloperidol) SS Metazapine SS Clonidine Hydrochloride(Clonid ine Hydrochloride) SS 24-Jun-2005 12:19 PM Page: 1976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/02ISR Number: 3952568-7Report Type:Direct Company Report #CTU 172841 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Olanzapine 20mg Intervention to Non-Insulin-Dependent Lilly PS Lilly ORAL 20 MG QHS Prevent Permanent ORAL Impairment/Damage Hctz C Date:07/24/02ISR Number: 3953590-7Report Type:Expedited (15-DaCompany Report #FR9115317JUL2002 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Soprol (Bisoprolol, Initial or Prolonged Health Tablet, 0) PS ORAL ORAL Other Professional Lipanthyl Other (Fenofibrate, ,0) SS ORAL ORAL Zyprexa (Olanzapine, ,0) SS ORAL SEE IMAGE 45 DAY Seresta (Oxazepam) C Oracilline (Phenoxymethylpenici llin) C Benerva (Thiamine Hydrochloride) C Date:07/25/02ISR Number: 3954090-0Report Type:Expedited (15-DaCompany Report #USA020616648 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa-Oral Ecchymosis Professional (Olanzapine) Pitting Oedema Company (Olanzapine) PS 10 MG/DAY 3 WK Weight Increased Representative Advair C Flonase (Fluticasone Propionate) C Calan Sr (Verapamil Hydrochloride) C Synthroid (Levothyroxine Sodium) C Maxalt (Rizatriptan Benzoate0 C Meclizine C Vioxx (Rofecoxib) C Date:07/25/02ISR Number: 3954091-2Report Type:Expedited (15-DaCompany Report #USA020617482 Age:46 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Arthralgia Asthenia Blood Albumin Decreased Blood Amylase Increased Blood Copper Increased Chills Cyanosis Headache 24-Jun-2005 12:19 PM Page: 1977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Malnutrition Myalgia Report Source Product Role Manufacturer Route Dose Duration Nail Discolouration Consumer Zyprexa-Oral Pallor (Olanzapine)(Olanzap Protein Total Decreased ine) PS 15 MG/DAY Pyrexia Celebrex(Celecoxib) C Tinnitus Premarin (Estrogens Conjugates0 C Xanax (Alprazolam) C Risperdal (Risperidone) C Effexor (Venlafaxine Hydrochloride) C Klonopin (Clonazepam) C Zyrtec (Certirizine Hydrochloride) C Trinsicon C Omega-3 Fatty Acids (Omega-3 Triglycerides) C Malic Acid C Magnesium C Wellbutrin (Amfebutamone Hydrochloride) C Iron Supplement C Vitamin B12 C Date:07/25/02ISR Number: 3954092-4Report Type:Expedited (15-DaCompany Report #USA020413674 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Hepatitis C Health (Olanzapine) Other Injection Site Irritation Professional (Olanzapine0 PS 20 MG/DAY Liver Function Test Humalog -(Lispro) SS Abnormal Depakote (Valproate Overdose Semisodium) C Pancreatitis Neurontin Skin Disorder (Gabapentin) C Weight Decreased Ambien (Zolpidem Weight Increased Tartrate) C Klonopin (Clonazepam) C Seroquel C Zantac (Ranitidine Hydrochloride) C Trileptal (Oxcarbazepine0 C Lantus (Insulin Glargine) C 24-Jun-2005 12:19 PM Page: 1978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/02ISR Number: 3954109-7Report Type:Expedited (15-DaCompany Report #USA020718237 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine)(Olanzap Company ine) PS 40 MG/DAY Representative Date:07/25/02ISR Number: 3954110-3Report Type:Expedited (15-DaCompany Report #USA020718193 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mood Altered Health Zyprexa-Oral Hospitalization - Neuroleptic Malignant Professional (Olanzapine) Initial or Prolonged Syndrome (Olanzapine) PS 15 MG/DAY Other Refusal Of Treatment By Klonopin Patient (Clonazepam) C Suicidal Ideation Haldol (Haloperidol) C Date:07/25/02ISR Number: 3954111-5Report Type:Expedited (15-DaCompany Report #USA020718105 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Complication Health Zyprexa-Oral Initial or Prolonged Neoplasm Malignant Professional (Olanzapine) Company (Olanzapine) PS Representative Date:07/25/02ISR Number: 3954112-7Report Type:Expedited (15-DaCompany Report #USA020718045 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Syndrome Professional (Olanzapine) Company (Olanzapine) PS Representative Date:07/25/02ISR Number: 3954113-9Report Type:Expedited (15-DaCompany Report #USA020718257 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 5 MG/DAY Representative Date:07/25/02ISR Number: 3954158-9Report Type:Expedited (15-DaCompany Report #USA020718251 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Prozac (Fluoxetine Hospitalization - Syndrome Professional Hydrochloride) PS 30 MG/DAY Initial or Prolonged Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG Trazadone 24-Jun-2005 12:19 PM Page: 1979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Trazadone) C Sonata (Zaleplon) C Date:07/25/02ISR Number: 3954843-9Report Type:Expedited (15-DaCompany Report #GBS020711014 Age:4 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Calcium Decreased Foreign Zyprexa-Oral Convulsion Neonatal Health (Olanzapine) Maternal Drugs Affecting Professional (Olanzapine) PS Foetus Other Prozac-Oral Muscle Twitching (Fluoxetine Neonatal Disorder Hydrochloride) C Date:07/25/02ISR Number: 3954845-2Report Type:Expedited (15-DaCompany Report #FR_020701220 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Zyprexa-Oral Therapeutic Health (Olanzapine) Pneumonia Aspiration Professional (Olanzapine) PS 20 MG/DAY Company Clopixol Representative (Zuclopenthixol Decanate) C Rivotril (Clonazepam) C Lepticur (Tropatepine Hydrochloride) C Subutex (Buprenorphine Hydrochloride) C Date:07/25/02ISR Number: 3954856-7Report Type:Expedited (15-DaCompany Report #DE_020709108 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gingival Bleeding Foreign Zyprexa-Oral Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 30 MG/DAY Company Representative Date:07/25/02ISR Number: 3954857-9Report Type:Expedited (15-DaCompany Report #EWC020731709 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Olanzapine-Oral Other Health (Olanzapine) PS Professional Diazepam C Company Representative 24-Jun-2005 12:19 PM Page: 1980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/02ISR Number: 3954866-XReport Type:Expedited (15-DaCompany Report #02P-062-0195153-00 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Excitability Foreign Akineton (Biperiden) Sudden Cardiac Death Health (Biperiden) PS ORAL 6 MG, 1 IN 1 Professional D, PER ORAL Nipolept SS ORAL 450 MG, 1 IN 1 D, PER ORAL Diazepam SS ORAL 30 MG, 1 IN 1 D, PER ORAL Perazine SS ORAL 600 MG, 1 IN 1 D, PER ORAL Olanzapine SS ORAL 7.5 MG, 1 IN 1 D, PER ORAL Carbamazepine SS ORAL 700 MG, 1 IN 1 D, PER ORAL Pholedrin-Longo-I-Si s C Date:07/25/02ISR Number: 3955290-6Report Type:Expedited (15-DaCompany Report #AU_020605094 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Olanzapine-Oral Initial or Prolonged Multi-Organ Failure Health (Olanzapine) PS 40 MG/DAY Nausea Professional Clozapine C Neuroleptic Malignant Other Valproate Sodium C Syndrome Sertraline C Pneumonia Primary Atypical Date:07/25/02ISR Number: 3955291-8Report Type:Expedited (15-DaCompany Report #US_020584836 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Olanzapine-Oral Hospitalization - Cardio-Respiratory Arrest Study (Olanzapine) PS 10 MG DAY Initial or Prolonged Cerebrovascular Disorder Health Levomepromazine C Other Convulsion Professional Flunitrazepam C Dyspnoea Other Famotidine C Fall Carbamazepine C Hypoglycaemia Loss Of Consciousness Miosis Pallor Date:07/25/02ISR Number: 3955294-3Report Type:Expedited (15-DaCompany Report #EWC020731719 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 10 MG/DAY Body Temperature Professional Increased Hypothyroidism 24-Jun-2005 12:19 PM Page: 1981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/02ISR Number: 3955295-5Report Type:Expedited (15-DaCompany Report #US_020785745 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abulia Foreign Zyprexa-Oral Initial or Prolonged Anxiety Literature (Olanzapine) Blood Bilirubin Increased Health (Olanzapine) PS 20 MG/DAY Blood Glucose Increased Professional Delusion Delusion Of Reference Hallucination, Auditory Hepatic Enzyme Increased Insomnia Mental Disorder Persecutory Delusion Polydipsia Social Avoidant Behaviour Somnolence Tension Thirst Weight Increased Date:07/26/02ISR Number: 3954292-3Report Type:Direct Company Report #CTU 173001 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Olanzapine 30mg/Day Blood Ketone Body Present Eli Lilly PS Eli Lilly 30MG DAY Diabetic Ketoacidosis Risperidone C Prozac C Lithobid C Wellbutrin C Date:07/26/02ISR Number: 3956651-1Report Type:Expedited (15-DaCompany Report #PHBS2002CH08085 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Mellerette PS ORAL 5 MG, TID, Initial or Prolonged Coma Health ORAL Confusional State Professional Zyprexa (Olanzapine) SS ORAL 5 MG, DAY, Hypokalaemia Other ORAL Hyponatraemia Deanxit(Melitracen, Hypotension Flupentixol) SS ORAL 1 CP/DAY, Somnolence ORAL Lexotanil (Bromazepam) SS ORAL 4.5 MG/DAY, ORAL Distraneurin SS ORAL 300 MG/DAY, ORAL Torem (Torasemide) C Nitroderm Tts C Zestril (Lisinopril) C Cardioaspirine C Benerva C Supradyn (Ferrous Carbonate, Magnesium Phosphate Monobasic, Manganese Sulfate, Molybdenum C Sesquioxide, Sodium 24-Jun-2005 12:19 PM Page: 1982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Borate, Vitamins Nos C Ciproxin (Ciprofloxacin) C Fraxiparine (Heparin-Fraction, Calcium Salt) C Kcl-Zyma C Dafalgan (Paracetamol) C Sirop Figue C Rocephine (Ceftriaxone) C Clamoxyl C Zovirax "Glaxo Wellcome" C Date:07/26/02ISR Number: 3956817-0Report Type:Expedited (15-DaCompany Report #001-0073-M0200236 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Dilantin Suspension Balance Disorder Professional (Phenytoin Sodium) PS ORAL NASOGASTRIC Confusional State TUBE Drug Level Above Olanzapine SS Therapeutic Rofecoxib C Drug Level Below Alprazolam C Therapeutic Risperidone C Fall Donepezil Medication Error Hydrochloride C Mental Status Changes Famotidine C Psychotic Disorder Citalopram Hydrobromide C Heparin -Fraction, Sodium Salt C Date:07/26/02ISR Number: 3988622-3Report Type:Periodic Company Report #PHEH2002US00829 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Mellaril(Thioridazin Initial or Prolonged Professional e Hydrochloride) Unknown PS Zyprexa (Olanzapine) SS Cogentn (Benzatropine Mesilate) C Date:07/29/02ISR Number: 3954594-0Report Type:Direct Company Report #CTU 173072 Age:34 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Disability Congenital Anomaly Other Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 1983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Haldol 600mgm Prozac PS EPIDURAL 2 TIME 2 Injury EPIDURAL Memory Impairment Zyprexa 100mgm Lilly SS Lilly DENTAL 2 TIMES 2 Performance Status DENTAL Decreased Date:07/29/02ISR Number: 3955041-5Report Type:Direct Company Report #CTU 173119 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Failure Topiramate 250mg Qhs PS 25MG QHS 1 Hospitalization - Hepatic Necrosis DOSE ONLY Initial or Prolonged Zyprexa (Incr Dose In Last Week) SS 10MG QD (INCR DOSE FOR 1 WEEK) Phenytek C Rappamine C Cellcept C Prograf C Date:07/29/02ISR Number: 3955051-8Report Type:Direct Company Report #CTU 173116 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Zydis (Olanzapine) PS ORAL 25MG PO HS Extrapyramidal Disorder Date:07/29/02ISR Number: 3956859-5Report Type:Expedited (15-DaCompany Report #S02-GER-01506-01 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Foreign Cipramil (Citalopram Health Hydrobromide) PS INTRAVENOUS 20 MG IV Professional Zyprexa (Olanzapine) SS 5 MG QD Other Nitrous Oxide C Catechloamines C Antibiotics C Date:07/31/02ISR Number: 3957994-8Report Type:Expedited (15-DaCompany Report #USA020617003 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa - Oral Gun Shot Wound Health (Olanzapine) Professional (Olanzapine) PS 10 MG/AT BEDTIME Celexa (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 1984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/02ISR Number: 3958087-6Report Type:Expedited (15-DaCompany Report #FR_020100595 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Diabetic Hyperglycaemic Literature (Olanzapine) Coma Health (Olanzapine) PS 10 MG/DAY Fatigue Professional Hyperglycaemia Company Medication Error Representative Oral Candidiasis Other Urine Ketone Body Present Weight Increased Date:08/01/02ISR Number: 3956266-5Report Type:Direct Company Report #CTU 173333 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Glucose Increased Olanzapine 20 Mg Glucose Urine Present Lilly PS Lilly OPHTHALMIC 20 MG QHS Glycosylated Haemoglobin ORAL Increased Quetiapine 1200 Mg Zeneca SS Zeneca ORAL 600 MG BID ORAL Atenolol C Dyazide C Date:08/01/02ISR Number: 3956856-XReport Type:Direct Company Report #CTU 173385 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Cholesterol Olanzapine PS ORAL 10MG BID PO Intervention to Increased Sinemet C Prevent Permanent Blood Triglycerides Glucophage C Impairment/Damage Increased Glucatrol C Diabetes Mellitus Zocor C Proventil C Date:08/01/02ISR Number: 3957162-XReport Type:Expedited (15-DaCompany Report #DE-020709062 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akinesia Foreign Zyprexa-Oral Hospitalization - Ascites Consumer (Olanzapine) Initial or Prolonged Asthenia Health (Olanzapine) PS Difficulty In Walking Professional Vioxx (Rofecoxi) C Heart Rate Decreased Other Amineurin Hepatic Failure (Amitriptyline Hepatitis Fulminant Hydrochloride) C Multi-Organ Failure Delix (Ramipril) C Date:08/01/02ISR Number: 3957531-8Report Type:Expedited (15-DaCompany Report #US_981012271 Age:39 YR Gender:Female I/FU:F Outcome PT Death Diabetic Ketoacidosis Dry Mouth Hepatomegaly 24-Jun-2005 12:19 PM Page: 1985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervous System Disorder Pulmonary Congestion Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Thirst Literature Zyprexa-Oral Toxicologic Test Abnormal Consumer (Olanzapine) Vision Blurred Health (Olanzapine) PS 20 MG/1 AT Weight Increased Professional BEDTIME Paxil (Paroxetine Hydrochloride) C Trazodone C Lithonate(Lithium Carbonate) C Buspar (Buspirone Hydrochloride) C Date:08/01/02ISR Number: 3957660-9Report Type:Expedited (15-DaCompany Report #DE_020709057 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Electrocardiogram Health (Olanzapine) Abnormal Professional (Olanzapine) PS 10 MG/DAY Hypotension Other Fluanxol(Flupentixol Pulmonary Embolism Dihydrochloride) C Pyrexia Tavor (Lorazepam) C Tachycardia Date:08/01/02ISR Number: 3957664-6Report Type:Expedited (15-DaCompany Report #US_020282087 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Foreign Olanzapine-Oral Hospitalization - Depressed Level Of Study (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Consciousness Health Cremin (Mosapramine Gastric Ulcer Haemorrhage Professional Hydrochloride) C Haemoglobin Decreased Other Gramalil (Tiapride Hypotension Hydrochloride) C Pulse Pressure Decreased Tasmolin (Biperiden) C Trihexyphenidyl Hydrochloride C Tsukushi Am C Chinese Medicine C Sennoside A C Rohypnol (Flunitrazepam) C Eurodin(Estazolam) C Barnetil(Sultopride) C Hirnamin(Levomeproma zine) C Depas (Etizolam) C Date:08/01/02ISR Number: 3957669-5Report Type:Expedited (15-DaCompany Report #US_011178209 Age:29 YR Gender:Male I/FU:F Outcome Death Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 1986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Foreign Zyprexa-Oral Increased Literature (Olanzapine) Cardio-Respiratory Arrest Health (Olanzapine) PS 15 MG/DAY Condition Aggravated Professional Timiperone C Diabetes Mellitus Company Biperiden C Diabetic Hyperosmolar Representative Sepazon(Cloxazolam) C Coma Other Lipantil(Fenofibrate Encephalopathy ) C Hepatotoxicity Seroquel C Hyperlipidaemia Serenace Hypoxia (Haloperidol) C Increased Appetite Impromen Weight Decreased (Bromperidol) C Date:08/01/02ISR Number: 3957695-6Report Type:Expedited (15-DaCompany Report #K200201341 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Jaundice Cholestatic Foreign Altace Capsules Health (Ramipril) Capsule, Professional 1.25 Mg PS ORAL 1.25 MG, QD, Other ORAL Olanzapine (Olanzapine) 2.5mg SS ORAL 2.5 MG, QD, ORAL Simvastatin(Simvasta tin) SS Omeprazole (Omeprazole) C Tramadol C Augmentin (Amoxicillin Trihydrate, Clavulanate Potassium) C Flucloxacillin C Trimethoprim C Acetylsalicylic Acid C Date:08/01/02ISR Number: 3957719-6Report Type:Expedited (15-DaCompany Report #US97091735A Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Zyprexa-Oral Initial or Prolonged Blood Glucose Increased Health (Olanzapine) Diabetic Coma Professional (Olanzapine) PS 5 MG/ 1 DAY 3 MON Hypersomnia Company Paxil (Paroxetine Mania Representative Hydrochloride) C Polydipsia Ativan (Lorazepam) C Klonopin (Clonazepam) C ` 24-Jun-2005 12:19 PM Page: 1987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3957729-9Report Type:Expedited (15-DaCompany Report #US_020685227 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Other Convulsion Health (Olanzapine) Mydriasis Professional (Olanzapine) PS 10 MG/DAY Company Seroquel C Representative Serenace Other (Haloperidol) C Chlorpromazine C Hirnamin (Levomepromazine) C Barnetil (Sultopride) C Tegretol (Carbamazepine) C Benzalin (Nitrazepam) C Pyrethia (Promethazine Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Date:08/01/02ISR Number: 3957739-1Report Type:Expedited (15-DaCompany Report #USA020516263 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa-Oral Hospitalization - Analgesic Drug Level Professional (Olanzapine) Initial or Prolonged Above Therapeutic (Olanzapine) PS 800 MG Other Apnoea Hydrocodone Blood Glucose Increased W/Acetaminophen C Blood Pressure Increased Cogentin Drug Screen Positive (Benzatropine Dystonia Mesilate) C Heart Rate Increased Venlafaxine C Hypertension Vistaril Intentional Misuse (Hydroxyzine Respiratory Depression Embonate) C Somnolence Gabapentin C Suicide Attempt Ranitidine C Calcium C Docusate C Ibuprofen C Date:08/01/02ISR Number: 3957741-XReport Type:Expedited (15-DaCompany Report #USA020718577 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Prozac-Oral Hospitalization - Drug Level Increased Professional (Fluoxetine) Initial or Prolonged Drug Toxicity (Fluoxetine Psychotic Disorder Hydrochloride) PS 40 MG/DAY Sedation Zyprexa-Oral (Olanzapine) (Olanzapine) SS Depakote (Valproate 24-Jun-2005 12:19 PM Page: 1988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Wellbutrin (Amfebutamone Hydrochloride) C Tenormin (Atenolol) C Date:08/01/02ISR Number: 3957742-1Report Type:Expedited (15-DaCompany Report #US_000542556 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Literature Zyprexa-Oral Increased Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 4 MON Pancreatitis Necrotising Tegretol (Carbamazepine) C Paxil (Paroxetine Hydrochloride) C Depakote (Valproate Semisodium) C Date:08/01/02ISR Number: 3957754-8Report Type:Expedited (15-DaCompany Report #DE_020709173 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Cipramil (Citalopram Hydrobromide) C Date:08/01/02ISR Number: 3957757-3Report Type:Expedited (15-DaCompany Report #US_020685388 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening C-Reactive Protein Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Decreased Appetite Professional (Olanzapine) PS 2.5 MG/DAY Depressed Level Of Company Chlorpromazine Consciousness Representative Hydrochloride C Diabetes Mellitus Other Thyradin S Diabetic Coma (Levothyroxine Infection Sodium) C Malaise Cortril Polydipsia (Hydrocortisone) C Polyuria Pyrexia Thirst White Blood Cell Count Increased Date:08/01/02ISR Number: 3957945-6Report Type:Expedited (15-DaCompany Report #US_020584382 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Death Drug Ineffective Foreign Fall Health Pulse Absent Professional Tachycardia Company 24-Jun-2005 12:19 PM Page: 1989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 5 MG/3 DAY Serenace (Haloperidol) C Tegretol (Carbamazepine) C Lodopin (Zotepine) C Hirnamin (Levomepromazine) C Barnetil (Sultopride) C Setous (Zotepine) C Date:08/01/02ISR Number: 3957946-8Report Type:Expedited (15-DaCompany Report #US_020685308 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa Other Blood Glucose Increased Health (Olanzapine) PS ORAL 10 MG/DAY Cardiac Failure Acute Professional Serenace Cardio-Respiratory Arrest Company (Haloperidol) C Chest X-Ray Abnormal Representative Barnetil Circulatory Collapse Other (Sultopride) C Convulsion Zotepine C Electrocardiogram Qt Propericiazine Prolonged (Periciazine) C Faecal Incontinence Biperiden C Ileus Paralytic Vegetamin B C Pallor Flunitrazepam C Pulse Absent Levomepromazine C Urinary Incontinence Lipovas Vomiting (Fenofibrate) C Date:08/01/02ISR Number: 3957947-XReport Type:Expedited (15-DaCompany Report #US_020685237 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Foreign Zyprexa Hospitalization - Phosphatase Increased Health (Olanzapine) PS 15 MG/DAY Initial or Prolonged Blood Cholesterol Professional Chlorpromazine C Increased Company Haloperidol C Blood Glucose Increased Representative Hirnamin Cardio-Respiratory Arrest Other (Levopromazine) C Condition Aggravated Depas Treatment Noncompliance (Etizolam) C Pyrethia (Promethazine Hydrochloride) C Rohypnol (Flunitrazepam) C Artane (Trihexyphenidyl Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3957978-XReport Type:Expedited (15-DaCompany Report #EWC020731746 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Oral(Olanzap Life-Threatening Cardiomyopathy Health ine)(Olanzapine) PS 13 MG/DAY 2 YR Hospitalization - Hypertension Professional Cipramil(Citalopram Initial or Prolonged Other Hydrobromide) C Kredex(Carvedilol) C Normorix C Flunipam (Flunitrazepam) C Nozinan(Levomepromaz ine) C Date:08/01/02ISR Number: 3957983-3Report Type:Expedited (15-DaCompany Report #DE_020709180 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain Foreign Zyprexa-Oral(Olanzap Initial or Prolonged Health ine)(Olanzapine) PS 10 MG/DAY Professional Remergil(Mitrazapine Other ) C Date:08/01/02ISR Number: 3957985-7Report Type:Expedited (15-DaCompany Report #DE_020709186 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral(Olanzap Initial or Prolonged Phosphokinase Mb Health ine)(Olanzapine) PS 10 MG/DAY Increased Professional Circulatory Collapse Other Rhabdomyolysis Supraventricular Tachycardia Date:08/01/02ISR Number: 3957991-2Report Type:Expedited (15-DaCompany Report #EWC020731766 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Torsade De Pointes Foreign Olanzapine-Oral(Olan Ventricular Fibrillation Health zapine) PS 5 MG/DAY Professional Lanoxin(Digoxin) C Other Lasix(Furosemide) C Date:08/01/02ISR Number: 3958010-4Report Type:Expedited (15-DaCompany Report #USA020718509 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zyprexa-Oral Pulmonary Embolism Professional (Olanzapine) (Olanzapine) PS 30 MG/DAY Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 1991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3958011-6Report Type:Expedited (15-DaCompany Report #USA020718460 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 600 MG Seroquel C Date:08/01/02ISR Number: 3958014-1Report Type:Expedited (15-DaCompany Report #USA020718438 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Neurosensory Consumer Zyprexa-Oral Pyrexia (Olanzapine) Tinnitus (Olanzapine) PS 2.5 MG/DAY Prandin (Prandin) C Glucophage (Metformin Hydrochloride) C Plavix (Clopidogrel Sulfate) C Calan (Verapamil Hydrochloride) C Mavik (Trandolapril) C Paxil (Paroxetine Hydrochloride) C Xanax (Alprazolam) C Date:08/01/02ISR Number: 3958067-0Report Type:Expedited (15-DaCompany Report #US_010973483 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anoxia Consumer Humalog-.(Lispro) PS 6 YR Convulsion Zyprexa-Oral Drug Toxicity (Olanzapine) Eye Rolling (Olanzapine) SS 15 MG/DAY Increased Appetite Neurontin Orthostatic Hypotension (Gabapentin) C Psychotic Disorder Paxil (Paroxetine Vomiting Hydrochloride) C Weight Increased Insulin Glargine C Levothyroxine C Date:08/01/02ISR Number: 3958684-8Report Type:Expedited (15-DaCompany Report #USA-2002-0001280 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Oxycontin Tablets Anxiety Health (Oxycodone Condition Aggravated Professional Hydrochloride) Cr Drug Toxicity Tablet PS Emotional Disorder Meperidine Pain Hydrochloride Splenomegaly (Pethidine Toxicologic Test Abnormal Hydrochloride) SS 3 DAY Propoxyphene (Dextropropoxyphene) SS 3 DAY Promethazine 24-Jun-2005 12:19 PM Page: 1992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Promethazine) SS 3 DAY Klonopin (Clonazepam) SS 3 DAY Zyprexa (Olanzapine) SS 3 DAY Acetaminophen (Paracetamol) SS 3 DAY Date:08/02/02ISR Number: 3957302-2Report Type:Direct Company Report #CTU 173407 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 5mg Eli Non-Insulin-Dependent Lilly PS Eli Lilly ORAL 1 DAY ORAL Date:08/02/02ISR Number: 3960444-9Report Type:Periodic Company Report #2001UW06439 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Literature Elavil PS ORAL 150 MG DAILY Initial or Prolonged Health PO Professional Elavil SS Olanzapine SS ORAL 10 MG DAILY PO Date:08/05/02ISR Number: 3957778-0Report Type:Direct Company Report #CTU 173476 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Zyprexa PS ORAL 10 MG PO HS 2 WK Neurontin C Lorazepam C Seroquel C Date:08/05/02ISR Number: 3959016-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01717 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Trileptal(Oxcarbazep Initial or Prolonged Increased Health ine) Film-Coated Aspartate Professional Tablet PS ORAL 300 MG/DAY; Aminotransferase Other 600 MG/DAY, Increased ORAL; 1200 Blood Alkaline MG/DAY, ORAL Phosphatase Increased Novalgin(Metamizole Blood Creatine Sodium) Drops SS ORAL ORAL Phosphokinase Increased Tiletamine Blood Lactate Hydrochloride Dehydrogenase Increased (Valoron) Blood Urea Increased (Tiletamine Gamma-Glutamyltransferase Hydrochloride) Drops SS Increased Sevredol(Morphine Oedema Sulfate) SS PRN Pulmonary Oedema Mst(Morphine Sulfate) SS Remergil(Mirtazapine ) SS Zyprexa(Olanzapine) SS Neurontin 24-Jun-2005 12:19 PM Page: 1993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Gabapentin) C Dytide (Benzthiazide) C Dilatrend (Carvedilol) C Marcumar (Phenprocoumon) C Mevinacor C Risperdal (Risperidone) C Eunerpan (Melperone Hydrochloride) C Movicol (Macrogol) C Diazepam Drops C Tavor C Nitro-Spray C Neurocil (Levomepromazine Maleate) C Durogesic (Fentanyl) C Loperamide (Loperamide) C Date:08/07/02ISR Number: 3959395-5Report Type:Direct Company Report #CTU 173682 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amputation Zyprexa PS Hospitalization - Diabetes Mellitus Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage Date:08/07/02ISR Number: 3959798-9Report Type:Expedited (15-DaCompany Report #DE_020709108 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Epistaxis Health (Olanzapine) Gingival Bleeding Professional (Olanzapine) PS 30 MG/DAY Idiopathic Company Thrombocytopenic Purpura Representative Melaena Other Splenomegaly Thrombocytopenia Date:08/07/02ISR Number: 3959799-0Report Type:Expedited (15-DaCompany Report #US_020584792 Age:54 YR Gender:Male I/FU:F Outcome PT Death Acute Coronary Syndrome Other Calcinosis Cardiac Failure Acute Cardiomegaly Coronary Artery Disease 24-Jun-2005 12:19 PM Page: 1994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram T Wave Amplitude Decreased Myocardial Ischaemia Report Source Product Role Manufacturer Route Dose Duration Oral Intake Reduced Foreign Zyprexa-Oral Pyrexia Literature (Olanzapine)(Olanzap Sudden Death Health ine) PS 15 MG/DAY Supraventricular Professional Propericiazine Extrasystoles Company (Periciazine) C Ventricular Extrasystoles Representative Levomepromazine C Other Flunitrazepam C Biperiden C Mosapride Citrate C Serrapeptase C Carbazochrome Sodium Sulfonate C Digoxin C Furosemide C Spironolactone C Date:08/07/02ISR Number: 3959800-4Report Type:Expedited (15-DaCompany Report #GBS011209836 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Disorder Foreign Zyprexa-Oral Hospitalization - Atherosclerosis Health (Olanzapine)(Olanzap Initial or Prolonged Duodenal Ulcer Professional ine) PS 15 MG/DAY Haemorrhage Other Electrocardiogram T Wave Amplitude Decreased Haemoglobin Decreased Liver Disorder Post Procedural Complication Protein Total Decreased Pulmonary Congestion Pulmonary Embolism Pulmonary Oedema Renal Disorder Spleen Congestion Thrombosis Date:08/07/02ISR Number: 3959801-6Report Type:Expedited (15-DaCompany Report #GBS000205507 Age:27 YR Gender:Female I/FU:F Outcome PT Death Arterial Disorder Atherosclerosis Cardiac Failure Acute Chest Pain Cough Dry Mouth Eosinophil Count Increased Gastroenteritis Influenza Liver Disorder Malaise Mineral Deficiency Ovarian Cyst 24-Jun-2005 12:19 PM Page: 1995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ovarian Enlargement Pleural Effusion Polydipsia Report Source Product Role Manufacturer Route Dose Duration Pulmonary Congestion Foreign Zyprexa (Olanzapine) PS 10 MG Pulmonary Haemorrhage Consumer Rash Health Scratch Professional Skin Ulcer Company Snoring Representative Spleen Congestion Other Thyroid Cyst Type I Hypersensitivity Vein Disorder Vomiting Weight Increased Date:08/07/02ISR Number: 3959836-3Report Type:Expedited (15-DaCompany Report #US_020786262 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa-Oral Initial or Prolonged Dehydration Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Impromen Representative (Bromperidol) C Other Date:08/07/02ISR Number: 3959837-5Report Type:Expedited (15-DaCompany Report #US_020786227 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphoria Foreign Zyprexa-Oral Insomnia Health (Olanzapine) Irritability Professional (Olanzapine) PS 10 MG/DAY Oedema Peripheral Other Clonazepam C Petechiae Date:08/07/02ISR Number: 3959848-XReport Type:Expedited (15-DaCompany Report #US_020281664 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Foreign Zyprexa-Oral Bradycardia Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS 7.5 MG//DAY Supraventricular Company Anginal Extrasystoles Representative (Dipyridamole) C Other Mexitil (Mexiletine Hydrochloride) C Sennoside A C Pyrethia (Promethazine Hydrochloride) C Eurodin (Estazolam) C 24-Jun-2005 12:19 PM Page: 1996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/02ISR Number: 3960123-8Report Type:Expedited (15-DaCompany Report #02P-163-0197125-00 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Health Depakote (Divalproex Initial or Prolonged Increased Professional Sodium) (Divalproex Required Company Sodium) PS ORAL 1000 MG, 1 IN Intervention to Representative 1 D, PER ORAL Prevent Permanent Olanzapine SS Impairment/Damage Date:08/07/02ISR Number: 3960151-2Report Type:Expedited (15-DaCompany Report #US_020786255 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Depression Health (Olanzapine) Drug Ineffective Professional (Olanzapine) PS 10 MG/DAY Company Representative Other Date:08/07/02ISR Number: 3960154-8Report Type:Expedited (15-DaCompany Report #US_020786127 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 3 WK Date:08/07/02ISR Number: 3960223-2Report Type:Expedited (15-DaCompany Report #USA020718619 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa-Oral Hospitalization - Hepatic Failure Professional (Olanzapine) Initial or Prolonged Intentional Misuse Company (Olanzapine) PS Other Respiratory Distress Representative Date:08/07/02ISR Number: 3960225-6Report Type:Expedited (15-DaCompany Report #USA020617448 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Dizziness (Olanzapine) PS Feeling Abnormal Trazodone C Lethargy Vioxx (Rofecoxib) C Lopressor (Metoprolol Tartrate) C Glucovance C Digitek (Digoxin) C 24-Jun-2005 12:19 PM Page: 1997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/02ISR Number: 3960226-8Report Type:Expedited (15-DaCompany Report #USA020718869 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:08/07/02ISR Number: 3960228-1Report Type:Expedited (15-DaCompany Report #USA020718623 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa-Oral Corrected Interval Professional (Olanzapine) Prolonged Company (Olanzapine) PS Representative Date:08/07/02ISR Number: 3960230-XReport Type:Expedited (15-DaCompany Report #USA020718761 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eating Disorder Consumer Zyprexa-Oral Initial or Prolonged Mania (Olanzapine) Paranoia (Olanzapine) PS 30 MG/DAY Lithium C Seroquel C Thorazine (Chlorpromazine Hydrochloride) C Ativan (Lorazepam) C Congentin (Benzatropine Mesilate) C Date:08/07/02ISR Number: 3960342-0Report Type:Expedited (15-DaCompany Report #US_020684963 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) Other Leukopenia Professional (Olanzapine) PS 10 MG/DAY Renal Cyst Company Levotomin Representative (Levomepromazine Other Maleate) C Rivotril (Clonazepam) C Metoclol (Metoclopramide) C Primperan (Metoclopramide) C Wypax (Lorazepam) C Lendormin (Brotizolam) C Rohypnol (Flunitrazepam) C 24-Jun-2005 12:19 PM Page: 1998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/02ISR Number: 3960359-6Report Type:Expedited (15-DaCompany Report #US_020785745 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agoraphobia Foreign Zyprexa Oral Initial or Prolonged Alanine Aminotransferase Literature (Olanzapine) PS 20 MG/DAY Increased Health Contomin Aspartate Professional (Chlorpromazine Aminotransferase Other Hydrochloride) C Increased Silece Blood Bilirubin Increased (Flunitrazepam) C Glucose Urine Present Hyperglycaemia Polydipsia Polyuria Thirst Date:08/07/02ISR Number: 3960467-XReport Type:Expedited (15-DaCompany Report #FR_020701239 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Zyprexa-Oral Initial or Prolonged Interstitial Lung Disease Health (Olanzapine) Lung Infection Professional (Olanzapine) PS 1 DSG FORM Lung Infiltration Other /DAY Lymphadenopathy Mediator (Belfluorex Pulmonary Hypertension Hydrochloride) C Renal Failure Date:08/07/02ISR Number: 3960468-1Report Type:Expedited (15-DaCompany Report #EWC020731876 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa-Oral(Olanzap Hospitalization - Central Pontine Health ine)(Olanzapine) PS Initial or Prolonged Myelinolysis Professional Ameride C Coma Other Modecate Drug Interaction (Fluphenazine Hyponatraemia Decanoate) C Paralysis Tranxilium Speech Disorder (Clorazepate Vomiting Dipotassium) C Date:08/07/02ISR Number: 3960472-3Report Type:Expedited (15-DaCompany Report #GBS020711165 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa-Olra Pacing Threshold Health (Olanzapine)(Olanzap Increased Professional ine) PS 2.5 MG/1 DAY Other Date:08/07/02ISR Number: 3960473-5Report Type:Expedited (15-DaCompany Report #US_020785797 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Fall Foreign Initial or Prolonged Humerus Fracture Study 24-Jun-2005 12:19 PM Page: 1999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS 5 MG DAY Miradol (Sulpiride) C Neuer (Cetraxate Hydrochloride) C Nelurolen (Nitrazepam) C Diovan (Valsartan) C Diazepam C Date:08/07/02ISR Number: 3960561-3Report Type:Expedited (15-DaCompany Report #GBS010508739 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa-Oral Initial or Prolonged First Degree Literature (Olanzapine) Other Bundle Branch Block Left Health (Olanzapine) PS 50 MG/DAY Overdose Professional Haloperidol C Other Procyclidine C Zimovane (Zopiclone) C Lorazepam C Date:08/07/02ISR Number: 3960566-2Report Type:Expedited (15-DaCompany Report #EWC020731803 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Foreign Olanzapine-Oral Initial or Prolonged Confusional State Health (Olanzapine) PS 10 MG/DAY Professional Amlodipine C Other Carbasalate Calcium C Temazepam C Lithium Carbonate C Clonazepam C Date:08/07/02ISR Number: 3960568-6Report Type:Expedited (15-DaCompany Report #DE_020508826 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ulcer Foreign Zyprexa-Oral Initial or Prolonged Insulin-Requiring Type Ii Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 15 MG/DAY Treatment Noncompliance Company Representative Other Date:08/07/02ISR Number: 3960570-4Report Type:Expedited (15-DaCompany Report #FR_020701247 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Guillain-Barre Syndrome Foreign Zyprexa-Oral Hospitalization - Hepatitis Health (Olanzapine) Initial or Prolonged Pulmonary Embolism Professional (Olanzapine) PS 15 MG/DAY Other Rhabdomyolysis Other Athymil (Mianserin Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone (Zopiclone) C Date:08/07/02ISR Number: 3960606-0Report Type:Expedited (15-DaCompany Report #USA020718669 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 3 MON Representative Celexa (Citalopram Hydrobromide) C Prevacid (Lansoprazole) C Date:08/09/02ISR Number: 3960639-4Report Type:Direct Company Report #CTU 173908 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa Zydis 20mg PS ORAL 20 MG PO HS Date:08/09/02ISR Number: 3962111-4Report Type:Expedited (15-DaCompany Report #MK200208-0092-1 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Anafranil 50 Mg Overdose Health Capsules 100 PS Toxicologic Test Abnormal Professional Olanzapine SS Chlorpromazine C Lorazepam C Procyclidine C Date:08/12/02ISR Number: 3961371-3Report Type:Expedited (15-DaCompany Report #US_020785745 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agoraphobia Foreign Zyprexa Initial or Prolonged Alanine Aminotransferase Literature (Olanzapine) PS 20 MG/DAY Other Increased Health Contomin Anxiety Professional (Chlorpromazine Aspartate Other Hydrochloride) C Aminotransferase Silece Increased (Flunitrazepam) C Blood Bilirubin Increased Glucose Urine Present Hyperglycaemia Polydipsia Polyuria Thirst Weight Decreased 24-Jun-2005 12:19 PM Page: 2001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/02ISR Number: 3961372-5Report Type:Expedited (15-DaCompany Report #DE_020709108 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa PS ORAL 30 MG/DAY Initial or Prolonged Gingival Bleeding Health Hepatic Cirrhosis Professional Idiopathic Company Thrombocytopenic Purpura Representative Splenomegaly Other Date:08/12/02ISR Number: 3961373-7Report Type:Expedited (15-DaCompany Report #EWC010325860 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa Hospitalization - Hyponatraemia Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Lung Infection Professional Akineton (Biperiden Oral Candidiasis Other Hydrochloride) C Skin Necrosis Stilnox (Zolpidem) C Skin Ulcer Date:08/12/02ISR Number: 3961374-9Report Type:Expedited (15-DaCompany Report #EWC010426475 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa PS ORAL 10 MG/DAY Initial or Prolonged Anaemia Health Lexomil (Bromazepam) C Hyponatraemia Professional Akineton (Biperiden Lung Infection Company Hydrochloride) C Oral Candidiasis Representative Xanax(Alprazolam) C Skin Necrosis Other Stilnox (Zolpidem) C Skin Ulcer Date:08/12/02ISR Number: 3961375-0Report Type:Expedited (15-DaCompany Report #EWC010727658 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Complications Of Maternal Health Nibiol (Nitroxoline) C Exposure To Therapeutic Professional Drugs Company Pre-Eclampsia Representative Pregnancy Other Urinary Tract Infection Date:08/12/02ISR Number: 3961376-2Report Type:Expedited (15-DaCompany Report #EWC010928307 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyrexa Hospitalization - Dialysis Health (Olanzapine) PS 30 MG/DAY Initial or Prolonged Haemoglobin Decreased Professional Cisordinol Prescribed Overdose Company (Clopenthixol Renal Failure Representative Hydrochloride) C Sepsis Other Nozinan (Levomepromazine) C Magnesia Dak 24-Jun-2005 12:19 PM Page: 2002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Magnesium Oxide) C Ferro Duretter (Ferrous Sulfate) C Disipal (Orphenadrine Hydrochloride) C Date:08/12/02ISR Number: 3961382-8Report Type:Expedited (15-DaCompany Report #B0274697A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Paxil PS ORAL SEE DOSAGE Initial or Prolonged Dialysis TEXT ORAL Disability Drug Interaction Cocaine (Formulation Other Hypervolaemia Unknown) (Cocaine) SS INTRAVENOUS INTRAVENOUS Myocardial Infarction Olanzapipne Overdose (Formulation Paraparesis Unknown) Renal Failure Acute (Olanzapine) SS ORAL 10 MG PER DAY Rhabdomyolysis ORAL Serotonin Syndrome Diamorphine Hydrochloride C Methadone Hydrochloride C Clonazepam C Lorazepam C Date:08/12/02ISR Number: 3961405-6Report Type:Expedited (15-DaCompany Report #US_020685308 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Zyprexa-Oral Other Blood Glucose Increased Health (Olanzapine) Cardiac Failure Acute Professional (Olanzapine) PS 10 MG/DAY Cardio-Respiratory Arrest Company Serenace Chest X-Ray Abnormal Representative (Haloperidol) C Circulatory Collapse Other Barnetil Convulsion (Sultopride) C Electrocardiogram Qt Zotepine C Prolonged Propericiazine Faecal Incontinence (Periciazine) C Ileus Paralytic Biperiden C Pulse Absent Vegetamin B C Pupillary Light Reflex Flunitrazepam C Tests Abnormal Levomepromazine C Urinary Incontinence Lipovas (Fenofibrate) C Date:08/12/02ISR Number: 3961410-XReport Type:Expedited (15-DaCompany Report #FR_020501018 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis B Antibody Foreign Zyprexa-Oral Positive Health (Olanzapine) Hepatocellular Damage Professional (Olanzapine) PS 10 MG/DAY Mean Cell Volume Company Stablon (Tianeptine) C Increased Representative Atarax (Hydroxyzine Other Hydrochloride) C Akineton Retard 24-Jun-2005 12:19 PM Page: 2003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Biperiden Hydrochloride) C Sulfarlem (Anethole Trithione) C Date:08/12/02ISR Number: 3961411-1Report Type:Expedited (15-DaCompany Report #GBS020711165 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/1 DAY Other Haloperidol C Date:08/12/02ISR Number: 3961420-2Report Type:Expedited (15-DaCompany Report #EWC020631185 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Nozinan (Levomepromazine) C Cisordinol (Clopenthixol Hydrochloride) C Disipal (Orphenadrine Hydrochloride) C Magnesia "Dak" (Magnesium Oxide) C Date:08/12/02ISR Number: 3962009-1Report Type:Expedited (15-DaCompany Report #USA020516020 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Zyprexa-Oral Other Coronary Artery Professional (Olanzapine) Atherosclerosis Company (Olanzapine) PS 30 MG/AT Deep Vein Thrombosis Representative BEDTIME Diabetes Mellitus Zoloft (Sertraline Electrocardiogram Hydrochloride) C Abnormal Depakote (Valproate Laboratory Test Abnormal Semisodium) C Pulmonary Embolism Klonopin Weight Increased (Clonazepam) C Topamax (Topiramate) C Date:08/12/02ISR Number: 3962203-XReport Type:Expedited (15-DaCompany Report #USA020617296 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine 24-Jun-2005 12:19 PM Page: 2004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS 40 MG/DAY Avalide C Date:08/14/02ISR Number: 3963294-2Report Type:Expedited (15-DaCompany Report #2002AP02135 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 700 MG DAILY Delusion Health PO Hallucination Professional Zyprexa SS ORAL 10 MG DAILY Mydriasis Other PO Serenace SS ORAL 15 MG DAILY PO Hirnamin C Contomin C Benzalin C Pyrethia C Artane C Barnetil C Tegretol C Date:08/15/02ISR Number: 3962560-4Report Type:Direct Company Report #CTU 174196 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Quetiapine PS Initial or Prolonged Phosphokinase Increased Haloperidal SS Olanzapine SS Date:08/15/02ISR Number: 3962594-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11735347 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Olanzapine PS ORAL Hospitalization - Erysipelas Professional Prednisone Acetate C 50 mg from 14 Initial or Prolonged Leukaemia Mar 02 to 27 Neutropenia Mar 02; 25 mg from 28 Mar 02 to 27 Jun Coversyl C Hctz C Losec C Neupogen C Cortisone C Date:08/15/02ISR Number: 3962914-6Report Type:Direct Company Report #CTU 174246 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Olanzapine 20 Mg Eli Weight Increased Lilly PS Eli Lilly ORAL 20 MG QHS ORAL Clonazepam C Zolpidem C Depakote C Paxil C Benztropine C 24-Jun-2005 12:19 PM Page: 2005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/02ISR Number: 3963909-9Report Type:Expedited (15-DaCompany Report #USA020718908 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 1 YR Representative Date:08/15/02ISR Number: 3963916-6Report Type:Expedited (15-DaCompany Report #USA020718938 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa - Oral Initial or Prolonged Convulsion Professional (Olanzapine) Other Hysterectomy (Olanzapine) PS Depakote (Valproate Semsodium) C Date:08/15/02ISR Number: 3963917-8Report Type:Expedited (15-DaCompany Report #US_020684962 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Zyprexa-Oral Exposure To Therapeutic Professional (Olanzapine) Drugs Company (Olanzapine) PS 27.5 MG/DAY Ectopic Pregnancy Representative Depakote (Valproate Maternal Drugs Affecting Semisodium) C Foetus Date:08/15/02ISR Number: 3963985-3Report Type:Expedited (15-DaCompany Report #B0273338A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Paxil Tablet Aggression Health (Paroxetine Condition Aggravated Professional Hydrochloride) PS ORAL 20 MG/PER Prostration DAY/ORAL Sleep Apnoea Syndrome Amisulpride Tablet Tachycardia (Amisulpride) SS ORAL 200 MG/PER Torsade De Pointes DAY/ORAL Cyamemazine (Cyamemazine) SS Olanzapine (Olanzapine) SS Haloperidol (Haloperidol) SS Date:08/15/02ISR Number: 3964108-7Report Type:Expedited (15-DaCompany Report #FR_020701262 Age:1 DY Gender:Female I/FU:I Outcome PT Hospitalization - Caesarean Section Initial or Prolonged Foetal Heart Rate Abnormal Maternal Drugs Affecting Foetus Pregnancy 24-Jun-2005 12:19 PM Page: 2006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premature Baby Small For Dates Baby Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa -Oral Health (Olanzapine)(Olanzap Professional ine) PS Other Tercian (Cyamemazine) C Date:08/15/02ISR Number: 3964109-9Report Type:Expedited (15-DaCompany Report #FR_020701263 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa-Oral Initial or Prolonged Hepatocellular Damage Health (Olanzapine) Hyperpyrexia Professional (Olanzapine) PS 10 MG/DAY Other Tercian (Cyamemazine) C Sulfarlem (Antehole Trithione) C Loxapac(Loxapine Succinate) C Date:08/15/02ISR Number: 3964165-8Report Type:Expedited (15-DaCompany Report #EWC020731892 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:08/15/02ISR Number: 3964328-1Report Type:Expedited (15-DaCompany Report #GBS020811213 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Zyprexa-Oral Initial or Prolonged Joint Stiffness Health (Olanzapine) Muscle Rigidity Professional (Olanzapine) PS 5 MG/2 DAY Tremor Other Paroxetine C Prednisolone C Date:08/15/02ISR Number: 3964352-9Report Type:Expedited (15-DaCompany Report #CA_020805276 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Foreign Olanzapine-Oral Hospitalization - Body Mass Index Increased Literature (Olanzapine) PS 20 MG/DAY 8 MON Initial or Prolonged Decreased Appetite Health Dehydration Professional Diabetes Mellitus Other Inadequate Control Diabetic Hyperosmolar Coma Vitreous Disorder Weight Increased 24-Jun-2005 12:19 PM Page: 2007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/02ISR Number: 3964353-0Report Type:Expedited (15-DaCompany Report #EWC020731861 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Olanzapine Oral Hospitalization - Syndrome Health (Olanzapine) PS 5 MG 3 DAY Initial or Prolonged Respiratory Disorder Professional Anti Parkinson C Other Date:08/15/02ISR Number: 3964354-2Report Type:Expedited (15-DaCompany Report #EWC020731872 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Olanzapine Oral Hospitalization - Drug Interaction Health (Olanzapine) PS 10 MG / DAY; Initial or Prolonged Hypervolaemia Professional A FEW MONTHS Ischaemic Cardiomyopathy Other Methadone C Myocardial Infarction Rivotril(Clonazepam) C Overdose Temesta(Lorazepam) C Paraparesis Deroxat (Paroxetine Renal Failure Acute Hydrochloride) C Rhabdomyolysis Heroin C Serotonin Syndrome Cocaine C Date:08/15/02ISR Number: 3964355-4Report Type:Expedited (15-DaCompany Report #FR_011000226 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa- Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS 10 MG/DAY Drugs Other Tercian Pre-Eclampsia (Cyamemazine) C Pregnancy Premature Baby Date:08/16/02ISR Number: 3962953-5Report Type:Direct Company Report #CTU 174336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Testosterone Zyprexa 10 Mg PS ORAL 10 MG AT Decreased NIGHT ORAL Diabetes Mellitus Actos C Hypertension Insulin C Risperdal C Date:08/19/02ISR Number: 3964740-0Report Type:Expedited (15-DaCompany Report #DE_020709180 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Remergil (Mirtazapine) C 24-Jun-2005 12:19 PM Page: 2008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3964523-1Report Type:Direct Company Report #CTU 174620 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Zyprexa 5mg Lilly PS Lilly Initial or Prolonged Tardive Dyskinesia Zyprexa Zydis 10mg Disability Lilly SS Lilly Asa C Ativan C Oscal C Prempro C Multivitamins C Tylenol C Seroquel C Benadryl C Maalox C Simethicone C Dulcolax C Vit E C Inderal C Zocor C Mom C Colace C Date:08/20/02ISR Number: 3964842-9Report Type:Expedited (15-DaCompany Report #USA020819557 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Disease Health Zyprexa Initial or Prolonged Mental Disorder Professional Zydis-Dispersible (Olanzapine) (Olanzapine) PS 10 MG/DAY Rifampin C Date:08/20/02ISR Number: 3964845-4Report Type:Expedited (15-DaCompany Report #USA020819482 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Other Syndrome Professional (Olanzapine) Company (Olanzapine) PS Representative Date:08/20/02ISR Number: 3964848-XReport Type:Expedited (15-DaCompany Report #USA020819396 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Loxapine C Date:08/20/02ISR Number: 3964850-8Report Type:Expedited (15-DaCompany Report #USA020819428 Age: Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Loss Of Consciousness Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:08/20/02ISR Number: 3965202-7Report Type:Expedited (15-DaCompany Report #CA_010503671 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Foreign Zyprexa-Oral Hospitalization - Aspartate Literature (Olanzapine) PS ORAL 20 MG/DAY Initial or Prolonged Aminotransferase Abnormal Health Asthenia Professional Blood Alkaline Company Phosphatase Abnormal Representative Diabetes Mellitus Other Diabetic Hyperosmolar Coma Drug Hypersensitivity Gamma-Glutamyltransferase Abnormal Laboratory Test Abnormal Malaise Psychotic Disorder Pulmonary Congestion Schizophrenia Treatment Noncompliance Vitreous Disorder Weight Increased Date:08/20/02ISR Number: 3965345-8Report Type:Expedited (15-DaCompany Report #US_000439362 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Literature Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Other Non-Insulin-Dependent Professional (Olanzapine) PS 20 MG/DAY Diabetic Ketoacidosis Company Effexor (Venlafaxine Hallucination Representative Hydrochloride) C Hypokalaemia Risperdal Renal Failure (Risperidone) C Renal Tubular Necrosis Imipramine C Thrombocytopenia Weight Increased Date:08/20/02ISR Number: 3965350-1Report Type:Expedited (15-DaCompany Report #US_000134251 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Diabetic Ketoacidosis Professional (Olanzapine) Renal Failure Company (Olanzapine) PS 20 MG/1 DAY Thrombocytopenia Representative Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 2010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3965400-2Report Type:Expedited (15-DaCompany Report #US_020786128 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urine Present Foreign Zyprexa-Oral Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS 20 MG/DAY Hepatocellular Damage Company Barnetil Hyperhidrosis Representative (Sultopride) C Neuroleptic Malignant Other Rohypnol Syndrome (Flunitrazepam) C Parkinsonism Benzalin (Nitrazepam) C Contomin (Chlorpromazine Hydrochloride) C Cravit (Levofloxacin) C Date:08/20/02ISR Number: 3965458-0Report Type:Expedited (15-DaCompany Report #GBS020811256 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Zyprexa-Oral Initial or Prolonged Central Pontine Health (Olanzapine) Myelinolysis Professional (Olanzapine) PS 7.5 MG Loss Of Consciousness Other Malaise Nervous System Disorder Polydipsia Date:08/20/02ISR Number: 3965466-XReport Type:Expedited (15-DaCompany Report #AU_020805299 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Aggression Health (Olanzapine) Psychotic Disorder Professional (Olanzapine) PS 2.5 MG/IN THE Company EVENING Representative Other Date:08/20/02ISR Number: 3965469-5Report Type:Expedited (15-DaCompany Report #EWC020831997 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa-Oral Initial or Prolonged Hyponatraemia Health (Olanzapine) Pneumonia Aspiration Professional (Olanzapine) PS 0.25 MG/DAY Company Paroxetin Representative (Paroxetine) C Other Saroten (Amitriptyline Hydrochloride) C Xanor (Alprazolam) C 24-Jun-2005 12:19 PM Page: 2011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3965505-6Report Type:Expedited (15-DaCompany Report #EWC020631202 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Zyprexa-Oral Initial or Prolonged Other (Olanzapine) (Olanzapine) PS Cipramil (Citalopram Hydrobromide) C Date:08/20/02ISR Number: 3965508-1Report Type:Expedited (15-DaCompany Report #FR_020100552 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Foreign Zyprexa-Oral Hepatocellular Damage Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Stilnox (Zolpidem) C Date:08/20/02ISR Number: 3965510-XReport Type:Expedited (15-DaCompany Report #FR_020701263 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Foreign Zyprexa-Oral Initial or Prolonged Hyperpyrexia Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Tercian (Cyamemazine) C Sulfarlem (Anethole Trithione) C Loxapac (Loxapine Succinate) C Date:08/20/02ISR Number: 3965511-1Report Type:Expedited (15-DaCompany Report #US_020685388 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Osmolarity Foreign Zyprexa-Oral Hospitalization - Increased Health (Olazapine) Initial or Prolonged Blood Ph Increased Professional (Olanzapine) PS 2.5 MG/DAY C-Reactive Protein Company Chlorpromazine Increased Representative Hydrochloride C Decreased Appetite Other Thyradin S Diabetes Mellitus (Levothyroxine Diabetic Coma Sodium) C Infection Cortril Malaise (Hydrocortisone) C Polydipsia Polyuria Pyrexia Thirst White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3965521-4Report Type:Expedited (15-DaCompany Report #US_020886787 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa-Oral Pulmonary Embolism Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:08/20/02ISR Number: 3965530-5Report Type:Expedited (15-DaCompany Report #US_020886730 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Olanzapine-Oral Gastric Ulcer Study (Olanzapine) PS 10 MG DAY Shock Haemorrhagic Health Serenace Professional (Haloperidol) C Other Contomin (Chlorpromazine Hydrochloride) C Tegretol (Carbamazepine) C Akineton (Biperiden Hydrochloride) C Eurodin (Estazolam) C Rohypnol (Flunitrazepam) C Vegetamin A C Date:08/20/02ISR Number: 3965555-XReport Type:Expedited (15-DaCompany Report #USA020617487 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Health Zyprexa-Oral Insomnia Professional (Olanzapine) Memory Impairment Company (Olanzapine) PS 5 MG/AT Mental Status Changes Representative BEDTIME Oedema Darvocet-. (Propoxyphene Hydrochloride) SS 100 MG/AS NEEDED Trazadone (Trazodone) C Aricept (Donepezil Hydrochloride) C Diovan Hct C Date:08/20/02ISR Number: 3965556-1Report Type:Expedited (15-DaCompany Report #EWC010627344 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Zyprexa (Olanzapine) PS 5 MG Initial or Prolonged Oedema Health Cipramil (Citalopram Disability Weight Increased Professional Hydrobromide) C Company Representative Other 24-Jun-2005 12:19 PM Page: 2013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3965558-5Report Type:Expedited (15-DaCompany Report #CA_020805276 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Foreign Olanzapine-Oral Hospitalization - Dehydration Literature (Olanzapine) PS 20 MG/DAY 8 MON Initial or Prolonged Diabetes Mellitus Health Inadequate Control Professional Diabetic Hyperosmolar Other Coma Psychotic Disorder Treatment Noncompliance Weight Increased Date:08/21/02ISR Number: 3964940-XReport Type:Direct Company Report #CTU 174688 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Olanzepine 10 PS ORAL 5 BID ORAL Initial or Prolonged Blood Pressure Abnormal Seroquel 50 SS ORAL 50 QD PRN Chills ORAL Cogwheel Rigidity Trazadone C Flushing Synthroid C Heart Rate Abnormal Effexor Xr C Hyperhidrosis Ativan C Joint Stiffness Cogentin C Mental Status Changes Colace C Palpitations Tylenol C Tachycardia Metronidazole C Tremor Erythromycin C Nizoral C Date:08/23/02ISR Number: 3966298-9Report Type:Direct Company Report #CTU 174927 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Swelling Zyprexa Zydis 5mg Initial or Prolonged Face Oedema Eli Lilly PS Eli Lilly ORAL 5MG PO BID Pallor Date:08/23/02ISR Number: 3966299-0Report Type:Direct Company Report #CTU 174928 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 2.5mg Lilly PS Lilly 2.5MG QHS Synthroid C Zocor C Tylenol C Oscal And Vit D C Multiple Vitamins And Iron C Nicotrol Inhaler I 24-Jun-2005 12:19 PM Page: 2014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/02ISR Number: 3967408-XReport Type:Expedited (15-DaCompany Report #02P-056-0198391-00 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Tranxene Initial or Prolonged Health (Clorazepate Professional Dipotassium) (Clorazepate Dipotassium) PS ORAL ORAL Mepronizine SS ORAL 410 MG, ORAL Olanzapine SS ORAL ORAL Nitrazepam SS ORAL 5 MG, ORAL Noctran 10 SS ORAL 10 MG, ORAL Mianserin Hydrochloride SS ORAL 10 MG, ORAL Diazepam C Zopiclone C Date:08/26/02ISR Number: 3967481-9Report Type:Direct Company Report #CTU 175052 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Zyprexa 5mg PS 5MG QD 1 WK Dehydration Paxil SS Joint Stiffness Pneumonia Sedation Tremor Vomiting Date:08/27/02ISR Number: 3967407-8Report Type:Direct Company Report #CTU 175108 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Zyprexa 5mg PS ORAL 5MG QHS ORAL Initial or Prolonged Hypercapnia Fosamax C Hypoxia Aleve C Liver Function Test Abnormal Myocardial Infarction Respiratory Failure Date:08/27/02ISR Number: 3967410-8Report Type:Direct Company Report #CTU 175110 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa 7.5mg PS ORAL 7.5MG QD ORAL Initial or Prolonged Phosphokinase Increased Selegiline 5mg SS ORAL 5MG BID ORAL Communication Disorder Sinemet C Confusional State Asa C Heart Rate Increased Plavix C Pyrexia Lasix C Respiratory Rate Lipitor C Increased Tremor 24-Jun-2005 12:19 PM Page: 2015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/02ISR Number: 3967817-9Report Type:Direct Company Report #CTU 175205 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Zyprexa 20 Mg Hospitalization - (Lilly) PS Lilly 20MG DAILY Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:08/27/02ISR Number: 3968101-XReport Type:Expedited (15-DaCompany Report #FR9115317JUL2002 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Soprol (Bisoprolol, Initial or Prolonged Professional Tablet, 0) PS ORAL ORAL Other Other Lipanthyl (Fenofibrate,, 0) SS ORAL ORAL Zyprexa (Olanzapine ,, 0) SS ORAL SEE IMAGE 45 DAY Seresta (Oxazepam) C Oracilline (Phenoxymethylpenici llin) C Benerva (Thiamine Hydrochloride) C Date:08/27/02ISR Number: 3969192-2Report Type:Expedited (15-DaCompany Report #A0377880A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Health Eskalith Tablet Initial or Prolonged Drug Level Increased Professional -Controlled Release Required Dyspepsia (Lithium Carbonate) PS ORAL UNK / SEE Intervention to Muscle Rigidity DOSAGE TEXT / Prevent Permanent Overdose ORAL Impairment/Damage Psychomotor Hyperactivity Buspirone Restlessness Hydrochloride Somnolence (Formulation Speech Disorder Unknown) Buspirone Staring Hydrochloride) SS ORAL ORAL Vomiting Olanzapine (Formulation Unknown)Olanzapine) SS ORAL ORAL Risperidone (Formulation Unknown)Risperidone) SS ORAL ORAL Benztropine Mesylate (Formulation Unknown)(Benztropine Mesylate) SS ORAL ORAL Thyroxine Sodium (Formulation Unknown) Levothyroxine Sodium) SS ORAL ORAL 24-Jun-2005 12:19 PM Page: 2016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/02ISR Number: 3968429-3Report Type:Expedited (15-DaCompany Report #USA020414202 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Consumer Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Ativan (Lorazepam) C Date:08/28/02ISR Number: 3968430-XReport Type:Expedited (15-DaCompany Report #USA020718908 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/2 DAY 11 MON Representative Synthroid (Levothyroxine Sodium) C Univasc (Moexipril Hydrochloride) C Trazadone (Trazodone) C Celebrex (Celecoxib) C Celexa (Citalopram Hydrobromide) C Date:08/28/02ISR Number: 3968506-7Report Type:Expedited (15-DaCompany Report #FR_020701247 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cytolytic Hepatitis Foreign Zyprexa-Oral Hospitalization - Guillain-Barre Syndrome Health (Olanzapine) Initial or Prolonged Hypokalaemia Professional (Olanzapine) PS 15 MG/DAY Other Hyponatraemia Athymil (Mianserin Pulmonary Embolism Hydrochloride) C Renal Failure Acute Zoplicone Rhabdomyolysis (Zopiclone) C Weight Increased Xanax (Alprazolam) C Procaine C Feldene (Piroxicam) C Miorel (Thiocolchicoside) C Ketum (Ketoprofen) C Dafalgan (Paracetamol) C Date:08/28/02ISR Number: 3968514-6Report Type:Expedited (15-DaCompany Report #GBS020510712 Age:66 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blepharitis Initial or Prolonged Cellulitis Orbital Change Of Bowel Habit Diarrhoea Extrapyramidal Disorder Faecal Incontinence Faeces Pale Gastrointestinal Disorder 24-Jun-2005 12:19 PM Page: 2017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastrooesophageal Reflux Disease Hepatitis B Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Foreign Zyprexa-Oral Insomnia Consumer (Olanzapine) Liver Disorder Health (Olanzapine) PS 10 MG/DAY Malaise Professional Priadel (Lithium Nausea Other Carbonate) C Rectal Tenesmus Zopiclone C Salivary Hypersecretion Temazepam C Skin Inflammation Urinary Incontinence Weight Increased Date:08/28/02ISR Number: 3968555-9Report Type:Expedited (15-DaCompany Report #US_020685388 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Osmolarity Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Decreased Appetite Professional (Olanzapine) PS 2.5 MG/DAY Depressed Level Of Company Chlorpromazine Consciousness Representative Hydrochloride C Diabetes Mellitus Other Thyradin S Diabetic Coma (Levothyroxine Infection Sodium) C Malaise Cortril White Blood Cell Count (Hydrocortisone) C Increased Date:08/28/02ISR Number: 3968556-0Report Type:Expedited (15-DaCompany Report #US_020786128 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urine Present Foreign Zyprexa-Oral Hepatotoxicity Health (Olanzapine) Neuroleptic Malignant Professional (Olanzapine) PS 20 MG/DAY Syndrome Company Barnetil Representative (Sultopride) C Other Rohypnol (Flunitrazepam) C Benzalin (Nitrazepam) C Contomin (Chlorpromazine Hydrochloride) C Cravit (Levofloxacin) C Date:08/29/02ISR Number: 3967827-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11735347 Age:30 YR Gender:Male I/FU:F Outcome PT Death Cardio-Respiratory Arrest Hospitalization - Erysipelas Initial or Prolonged Laryngitis Leukaemia Neutropenia 24-Jun-2005 12:19 PM Page: 2018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Streptococcal Infection White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Olanzapine PS ORAL Prednisone Acetate C 50 mg from 14 Mar 02 to 27 Mar 02; 25 mg from 28 Mar 02 to 27 Jun Coversyl C Hctz C Losec C Neupogen C Cortisone C Date:08/29/02ISR Number: 3968618-8Report Type:Direct Company Report #CTU 175339 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Zyprexa 2.5 Mg PS ONE DOSE/HR Hospitalization - Renal Failure Acute Initial or Prolonged Date:08/30/02ISR Number: 3969713-XReport Type:Expedited (15-DaCompany Report #FR_020801322 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Olanzapine PS 5 MG/DAY Initial or Prolonged Delusion Of Grandeur Literature Amisulpride C Insomnia Health Lithium C Irritability Professional Mania Other Date:08/30/02ISR Number: 3969716-5Report Type:Expedited (15-DaCompany Report #EWC020832022 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa Initial or Prolonged Diarrhoea Health (Olanzapine) PS 20 MG/DAY Professional Venlafaxine C Other Mirtazapine C Date:08/30/02ISR Number: 3970046-6Report Type:Expedited (15-DaCompany Report #US_020887198 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/02ISR Number: 3970047-8Report Type:Expedited (15-DaCompany Report #US_020886918 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:08/30/02ISR Number: 3970222-2Report Type:Expedited (15-DaCompany Report #FR_020801330 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa-Oral Initial or Prolonged Neutropenia Health (Olanzapine) Professional (Olanzapine) PS 1 DSG Other FORM/DAY Lipanthyl (Fenofibrate) C Soprol (Bisoprolol Fumarate) C Oracilline (Phenoxymethylpenici llin) C Benerva (Thiamine Hydrochloride) C Seresta (Oxazepam) C Date:08/30/02ISR Number: 3970223-4Report Type:Expedited (15-DaCompany Report #EWC020832087 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Other Depamide Increased (Valpromide) C Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Hyponatraemia Date:08/30/02ISR Number: 3970263-5Report Type:Expedited (15-DaCompany Report #USA020819733 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/1 DAY Representative Date:08/30/02ISR Number: 3970282-9Report Type:Expedited (15-DaCompany Report #US_020886789 Age:32 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate 24-Jun-2005 12:19 PM Page: 2020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Creatine Phosphokinase Increased Report Source Product Role Manufacturer Route Dose Duration Crush Syndrome Foreign Zyprexa-Oral Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS 280 MG/DAY Overdose Company Wintermin(Chlorproma Representative zine Hydrochloride) C Other Hirnamin (Levomepromazine) C Benzalin (Nitrazepam) C Pyrethia (Promethazine Hydrochloride) C Date:08/30/02ISR Number: 3970283-0Report Type:Expedited (15-DaCompany Report #US_020887033 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine)(Olanzap Aspartate Professional ine) PS 10 MG/DAY Aminotransferase Company Impromen Increased Representative (Bromperidol) C Blood Cholesterol Other Tasmolin (Biperiden) C Increased Mevalotin Blood Triglycerides (Pravastatin Sodium) C Increased Levomepromazine C Condition Aggravated Dalmate (Flurazepam Gamma-Glutamyltransferase Hydrochloride) C Increased Hyperlipidaemia Weight Increased White Blood Cell Count Increased Date:08/30/02ISR Number: 3970284-2Report Type:Expedited (15-DaCompany Report #US_020887038 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Zyprexa-Oral Diabetes Mellitus Health (Olanzapine) Hunger Professional (Olanzapine) PS 10 MG/DAY Obesity Company Lendormin(Brotizolam Representative ) C Other Date:08/30/02ISR Number: 3970285-4Report Type:Expedited (15-DaCompany Report #GBS020811275 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blister Foreign Zyprexa-Oral Initial or Prolonged Overdose Health (Olanzapine) Rash Professional (Olanzapine) PS 400 MG/DAY Other Paracetamol C Zopiclone C Valproate Sodium C 24-Jun-2005 12:19 PM Page: 2021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/02ISR Number: 3970569-XReport Type:Expedited (15-DaCompany Report #USA020819827 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Bypass Health Zyprexa-Oral Initial or Prolonged Hallucination, Visual Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Chloral Hydrate C Date:08/30/02ISR Number: 3970571-8Report Type:Expedited (15-DaCompany Report #USA020819605 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Consumer Zyprexa-Oral Initial or Prolonged Weight Increased (Olanzapine) (Olanzapine) PS 10 MG/1 DAY 2 YR Seroquel C Singulair (Montelukast Sodium) C Desloratadine C Date:08/30/02ISR Number: 3970594-9Report Type:Expedited (15-DaCompany Report #US_020886973 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Deterioration Health Zyprexa-Oral Convulsion Professional (Olanzapine) Depressed Level Of Company (Olanzapine) PS 2.5 MG/2 DAY Consciousness Representative (A FEW YEARS) General Physical Health Lisinopril C Deterioration Lorazepam C Mental Impairment Pilocarpine Eye Drops C Latanoprost C Clotrimazole C Date:08/30/02ISR Number: 3970595-0Report Type:Expedited (15-DaCompany Report #USA020820014 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Norvasc (Amlodipine Besilate) C Haldol (Haloperidol) C Date:08/30/02ISR Number: 3970597-4Report Type:Expedited (15-DaCompany Report #USA020819716 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa-Oral Initial or Prolonged Mania Professional (Olanzapine) Pressure Of Speech Company (Olanzapine) PS 20 MG/AT Representative BEDTIME Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/02ISR Number: 3970598-6Report Type:Expedited (15-DaCompany Report #USA020819616 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Zyprexa-Oral Other Professional (Olanzapine) Company (Olanzapine) PS Representative Date:08/30/02ISR Number: 3970600-1Report Type:Expedited (15-DaCompany Report #USA020819643 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa-Oral Other Professional (Olanzapine) Company (Olanzapine) PS Representative Date:08/30/02ISR Number: 3970601-3Report Type:Expedited (15-DaCompany Report #USA020819750 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Consumer Zyprexa-Oral Myocardial Infarction (Olanzapine) (Olanzapine) PS 25 MG/1 DAY 2 YR Date:09/04/02ISR Number: 3971288-6Report Type:Expedited (15-DaCompany Report #MK200208-0329-1 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Circulatory Collapse Foreign Anafranil 25mg Haemodialysis Health Capsules 100 PS Neuroleptic Malignant Professional Largactil SS Syndrome Xanax SS Neuropathy Peripheral Zyprexa SS Rhabdomyolysis Tremor Date:09/04/02ISR Number: 3971652-5Report Type:Expedited (15-DaCompany Report #MK200206-0274-2 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anticholinergic Syndrome Foreign Anafranil 50 Mg Atrioventricular Block Capsules PS 100MG DAILY Complete Zyprexa SS Cardiogenic Shock Stangyl SS Coronary Artery Disease Remergil C Myocardial Ischaemia Resuscitation Date:09/05/02ISR Number: 3971298-9Report Type:Direct Company Report #CTU 175735 Age:31 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Disability 24-Jun-2005 12:19 PM Page: 2023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Diabetes Mellitus Zyprexa PS Non-Insulin-Dependent Geodon SS Hirsutism Polycystic Ovaries Weight Increased Date:09/05/02ISR Number: 3972043-3Report Type:Expedited (15-DaCompany Report #USA020819968 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Prozac-Oral Initial or Prolonged Bipolar Disorder (Fluoxetine) Condition Aggravated (Fluoxetine Constipation Hydrochloride) PS 80 MG/DAY Rectal Tenesmus Zyprexa-Oral Self Injurious Behaviour (Olanzapine) Vertigo (Olanzapine) SS 5 MG/DAY 5 DAY Fluoxetine C Zocor (Simvastatin) C Aspirin C Tegretol (Carbamazepine) C Xanax (Alprazolam) C Date:09/05/02ISR Number: 3972055-XReport Type:Expedited (15-DaCompany Report #USA020819953 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antiphospholipid Syndrome Health Zyprexa-Oral Haemolytic Anaemia Professional (Olanzapine) (Olanzapine) PS 5 MG/1 DAY 7 YR Date:09/05/02ISR Number: 3972056-1Report Type:Expedited (15-DaCompany Report #USA020717984 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) (Olanzapine) PS 20 MG/D 4 YR Risperdal (Risperidone) C Date:09/05/02ISR Number: 3972057-3Report Type:Expedited (15-DaCompany Report #USA020820175 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Health Zyprexa-Oral Medication Error Professional (Olanzapine) Company (Olanzapine) PS 15 MG/1 DAY 1 DAY Representative 24-Jun-2005 12:19 PM Page: 2024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/02ISR Number: 3972059-7Report Type:Expedited (15-DaCompany Report #USA020820096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Zyprexa-Oral Dyspnoea Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY Representative Date:09/05/02ISR Number: 3972060-3Report Type:Expedited (15-DaCompany Report #USA020820094 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Liver Function Test (Olanzapine) PS 20 MG/DAY Abnormal Depakote (Valproate Skin Cancer Semisodium) C Weight Increased Paxil (Paroxetine Hydrochloride) C Klonopin (Clonazepam) C Date:09/05/02ISR Number: 3972071-8Report Type:Expedited (15-DaCompany Report #US_020887261 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oxygen Saturation Company Zyprexa-Oral Initial or Prolonged Decreased Representative (Olanzapine) Pco2 Increased (Olanzapine) PS 5 MG/DAY 8 DAY Somnolence Date:09/05/02ISR Number: 3972287-0Report Type:Expedited (15-DaCompany Report #US_020887362 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Purpura Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Company Representative Other Date:09/05/02ISR Number: 3972292-4Report Type:Expedited (15-DaCompany Report #DE_020809473 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-Oral Initial or Prolonged Drug Level Increased Health (Olanzapine) Neuroleptic Malignant Professional (Olanzapine) PS Syndrome Company Lithium C Renal Failure Acute Representative Other 24-Jun-2005 12:19 PM Page: 2025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/02ISR Number: 3972293-6Report Type:Expedited (15-DaCompany Report #DE_020809471 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-Oral Initial or Prolonged Drug Level Decreased Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Carbanazepine C Representative Other Date:09/05/02ISR Number: 3972294-8Report Type:Expedited (15-DaCompany Report #DE_020809467 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Foreign Zyprexa-Oral Haemorrhage Consumer (Olanzapine) Other (Olanzapine) PS 10 MG/2 DAY Date:09/05/02ISR Number: 3972295-XReport Type:Expedited (15-DaCompany Report #EWC020832118 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Olanzapine-Oral Initial or Prolonged Psychotic Disorder Health (Olanzapine) PS 10 MG/DAY Other Professional Haloperidol C Other Date:09/05/02ISR Number: 3972296-1Report Type:Expedited (15-DaCompany Report #FR_020801338 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Foreign Zyprexa-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) Tremor Professional (Olanzapine) PS 1 DSG Company FORM/DAY Representative Other Date:09/05/02ISR Number: 3972297-3Report Type:Expedited (15-DaCompany Report #EWC020832110 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Olanzapine-Oral Initial or Prolonged Cerebral Infarction Health (Olanzapine) PS 20 MG/DAY Disability Nervous System Disorder Professional Claritine Paralysis Other (Loratadine) C Date:09/05/02ISR Number: 3972298-5Report Type:Expedited (15-DaCompany Report #US_020887313 Age:53 YR Gender:Male I/FU:I Outcome PT Life-Threatening Body Temperature Other Increased Convulsion Depressed Level Of Consciousness 24-Jun-2005 12:19 PM Page: 2026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Nausea Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Foreign Zyprexa-Oral Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Representative Other Date:09/05/02ISR Number: 3972302-4Report Type:Expedited (15-DaCompany Report #EWC020832087 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Other Depamide Increased (Valpromide) C Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Hyponatraemia Psychotic Disorder Date:09/05/02ISR Number: 3972303-6Report Type:Expedited (15-DaCompany Report #DE_020508826 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Insulin-Dependent Health (Olanzapine) Diabetic Complication Professional (Olanzapine) PS 15 MG/DAY Prescribed Overdose Company Treatment Noncompliance Representative Other Date:09/05/02ISR Number: 3972304-8Report Type:Expedited (15-DaCompany Report #US_020886789 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 280 MG/DAY Aminotransferase Company Wintermin Increased Representative (Chlorpromazine Blood Creatine Other Hydrochloride) C Phosphokinase Increased Hirnamin Crush Syndrome (Levomepromazine) C Depressed Level Of Benzalin Consciousness (Nitrazepam) C Overdose Pyrethia (Promethazine Hydrochloride) C .. C .. C 24-Jun-2005 12:19 PM Page: 2027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/02ISR Number: 3972305-XReport Type:Expedited (15-DaCompany Report #US_020383040 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zyprexa-Oral Asthenia Health (Olanzapine) Dehydration Professional (Olanzapine) PS 20 MG/DAY Insomnia Company Quetiapine Fumarate C Overdose Representative Silece Overwork Other (Flunitrazepam) C Treatment Noncompliance Anafranil Weight Decreased (Clomipramine Hydrochloride0 C Diazepam C Wintermin (Chlorpromazine Hydrochloride) C Date:09/05/02ISR Number: 3972744-7Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Lithium PS ORAL ORAL Formication Professional Ziprasidone SS ORAL 120 MG (BID), Insomnia ORAL Lethargy Mellaril (Thioridazine Hydrochloride) SS Zyprexa (Olanzapine) SS Verapamil C Synthroid (Levothyroxine Sodium) C Date:09/05/02ISR Number: 3972759-9Report Type:Expedited (15-DaCompany Report #US_990217971 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Literature Zyprexa-Oral Other Distress Syndrome Health (Olanzapine) Confusional State Professional (Olanzapine) PS Csf Glucose Increased Depakote (Valproate Csf Protein Increased Semisodium) C Drug Interaction Lithium C Hepatic Steatosis Clonazepam C Hypotension Claritin Lethargy (Loratadine) C Metabolic Acidosis Bronchodilators C Nervous System Disorder Oxygen Saturation Decreased Pancreatitis Haemorrhagic Tachycardia 24-Jun-2005 12:19 PM Page: 2028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/02ISR Number: 3972313-9Report Type:Expedited (15-DaCompany Report #EMADSS2002005118 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Foreign Risperdal (2 Mg Condition Aggravated Health Tablet) Extrapyramidal Disorder Professional (Risperidone) PS ORAL 2 MG, DAILY, Joint Stiffness ORAL Muscle Rigidity Dipiperon Neoplasm (Unspecified) (Pipamperone) SS 60 MG, DAILY, Eunerpan (Melperone Hydrochloride) SS ORAL 50 MG, DAILY, ORAL Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, ORAL Date:09/06/02ISR Number: 3973432-3Report Type:Expedited (15-DaCompany Report #2002AP02542 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Hypotension Health PO Initial or Prolonged Hypothermia Professional Zyprexa SS ORAL 5 MG DAILY PO Other Pursennid C Akineton C Depas C Efotinon C Landsen C Risumic C Tegretol C Magnesium Oxide C Pantosin C Evamyl C Doral C Date:09/09/02ISR Number: 3973266-XReport Type:Direct Company Report #USP 55039 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec (Cetirizine Hydrochloride) PS Pfizer Zyprexa (Olanzapine) SS Lilly Date:09/10/02ISR Number: 3973546-8Report Type:Expedited (15-DaCompany Report #USA020718669 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa-Oral Neutrophil Count Professional (Olanzapine) Decreased Company (Olanzapine) PS 5 MG/1 AT Pneumonia Representative BEDTIME 3 MON White Blood Cell Count Celexa (Citalopram Decreased Hydrobromide) C Prevacid (Lansoprazole) C 24-Jun-2005 12:19 PM Page: 2029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/02ISR Number: 3973564-XReport Type:Expedited (15-DaCompany Report #DE_020809471 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Foreign Zyprexa Oral Initial or Prolonged Treatment Noncompliance Health (Olanzapine) Weight Increased Professional (Olanzapine) PS 15 MG/DAY Company Carbamazepine C Representative Other Date:09/10/02ISR Number: 3973565-1Report Type:Expedited (15-DaCompany Report #EWC011028709 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arterial Stenosis Limb Foreign Olanzapine-Oral Initial or Prolonged Arteriopathic Disease Study (Olanzapine) PS 1 MG/DAY Disability Arteritis Health Tenormine (Atenolol) C Atherosclerosis Professional Skenan (Morphine Condition Aggravated Other Sulfate) C Decubitus Ulcer Calcite D C Gastric Ulcer Exelon (Rivastigmine Haematemesis Tartrate) C Leg Amputation Motilium Oesophageal Ulcer (Domperidone) C Skin Necrosis Umuline Profil 30 Skin Ulcer (Insulin Human Vomiting Injection, Isophane) C Hydromorphone Hydrochloride C Lactulose C Date:09/10/02ISR Number: 3973585-7Report Type:Expedited (15-DaCompany Report #US_020887033 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Blood Triglycerides Professional (Olanzapine) PS 10 MG/DAY Increased Company Impromen Hepatic Function Abnormal Representative (Bromperidol) C Hyperlipidaemia Other Tasmolin (Biperiden) C Jaundice Mevalotin Malaise (Pravastatin Sodium) C Retching Levomepromazine C Weight Increased Dalmate (Flurazepam White Blood Cell Count Hydrochloride) C Increased Date:09/10/02ISR Number: 3973592-4Report Type:Expedited (15-DaCompany Report #EWC020832148 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa Health (Olanzapine) PS ORAL 10 MG/DAY Professional Seropram (Citalopram Company Hydrobromide) C Representative Rivotril Other (Clonazepam) C 24-Jun-2005 12:19 PM Page: 2030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/02ISR Number: 3973593-6Report Type:Expedited (15-DaCompany Report #US_020887549 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine PS ORAL ORAL Increased Health Wypax (Lorazepam) C Aspartate Professional Rohypnol Aminotransferase Company (Flunitrazepam) C Increased Representative Chlorpromazine C Blood Lactate Other Dehydrogenase Increased Gamma-Glutamyltransferase Increased Laboratory Test Abnormal Pyrexia Date:09/10/02ISR Number: 3973695-4Report Type:Expedited (15-DaCompany Report #USA020313015 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:09/10/02ISR Number: 3973702-9Report Type:Expedited (15-DaCompany Report #USA020718045 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa - Oral Other Joint Stiffness Professional (Olanzapine) Pyrexia Company (Olanzapine) PS 10 MG/DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/DAY Trazadone (Trazodone) C Vicodin C Concerta (Methylphenidate Hydrochloride) C Date:09/10/02ISR Number: 3973767-4Report Type:Expedited (15-DaCompany Report #USA020820247 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa Professional (Olanzapine) PS ORAL Company Representative Date:09/10/02ISR Number: 3973770-4Report Type:Expedited (15-DaCompany Report #USA020820424 Age: Gender:Male I/FU:I Outcome PT Death Completed Suicide Depression 24-Jun-2005 12:19 PM Page: 2031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injury Asphyxiation Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa Professional (Olanzapine) PS ORAL 5 MG/DAY Company Effexor Representative (Venlafaxine Hydrochloride) SS Lamcital (Lamotrigine) C Date:09/10/02ISR Number: 3973803-5Report Type:Expedited (15-DaCompany Report #USA020820226 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Consumer Zyprexa-Oral Initial or Prolonged Heart Rate Increased (Olanzapine) Other Medication Error (Olanzapine) PS 5 MG/1 DAY Date:09/10/02ISR Number: 3973805-9Report Type:Expedited (15-DaCompany Report #USA020820231 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Tachycardia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:09/10/02ISR Number: 3973807-2Report Type:Expedited (15-DaCompany Report #US_020887506 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Consumer Zyprexa-Oral Initial or Prolonged Renal Failure (Olanzapine) (Olanzapine) PS Date:09/11/02ISR Number: 3974698-6Report Type:Expedited (15-DaCompany Report #B0278841A US02678 Age:27 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Morphine Sulphate PS ORAL ORAL Intentional Misuse Health Olanzapine Unknown SS ORAL ORAL Professional Other Date:09/11/02ISR Number: 3974733-5Report Type:Direct Company Report #USP 54888 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Xigris(Drotrecogin) PS Lilly Zydis SS 24-Jun-2005 12:19 PM Page: 2032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/02ISR Number: 3975122-XReport Type:Expedited (15-DaCompany Report #2002AP02542 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Blood Pressure Decreased Health PO Initial or Prolonged Condition Aggravated Professional Zyprexa SS ORAL 5 MG DAILY PO Drug Interaction Other Pursennid C Gait Disturbance Akineton C Hypothermia Depas C Efotinon C Landsen C Risumic C Tegretol C Magnesium Oxide C Pantosin C Evamyl C Doral C Date:09/12/02ISR Number: 3975243-1Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Lithium PS ORAL 900 MG Drug Interaction Professional (DAILY), ORAL Feeling Abnormal Geodon (Ziprasidone) SS ORAL 1`20 MG Insomnia (BID), ORAL Lethargy Mellaril (Thiridazine Hydrochloride) SS Zyprexa (Olanzapine) SS Verapamil C Synthroid (Levothyroxine Sodium) C Date:09/13/02ISR Number: 3975639-8Report Type:Direct Company Report #CTU 176358 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Olanzapine 10 Mg PS ORAL 1 TAB ORAL Initial or Prolonged Increased Risperidone 4 Mg SS ORAL 2 TABS ORAL Diabetes Mellitus Drug Effect Decreased Pancreatitis Date:09/16/02ISR Number: 3976068-3Report Type:Direct Company Report #CTU 176484 Age:12 YR Gender:Male I/FU:I Outcome PT Required Dry Mouth Intervention to Fatigue Prevent Permanent Headache Impairment/Damage Heart Rate Increased Heart Rate Irregular Memory Impairment Motor Dysfunction Muscle Spasms Polydipsia 24-Jun-2005 12:19 PM Page: 2033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Zyprexa 2.5mg No Labels Were Given To Me Just PS ORAL PO BID TWICE A DAY ORAL Clonidine 0.2 Mg SS 1, PO, BID,TWICE DAILY Ddavp C Concerta C Vistaril C Thorazine C Date:09/16/02ISR Number: 3976162-7Report Type:Direct Company Report #CTU 176472 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Zyprexa PS ORAL ONE-TIME ORAL Initial or Prolonged Date:09/16/02ISR Number: 3976682-5Report Type:Expedited (15-DaCompany Report #2002090011 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Doral (Quazepam) Initial or Prolonged Phosphokinase Increased Health Tablets PS ORAL 20 MG/D, PO Difficulty In Walking Professional Haloperidol SS ORAL SEE IMAGE Dysuria Olanzapine SS ORAL 10 MG/D, PO Neuroleptic Malignant Bromocriptine Syndrome Mesilate C Dantrolene Sodium C Trihexyphenidyl Hcl C Biperiden Hcl C Brotizolam C Sennosides C Valsartan C Date:09/17/02ISR Number: 3976582-0Report Type:Direct Company Report #CTU 176703 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Zyprexa 10 Mg PS ORAL 10MG PO BID Initial or Prolonged Depakote C Thiamine C Folic Acid C Date:09/17/02ISR Number: 3976720-XReport Type:Direct Company Report #CTU 176641 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Chlordiazepoxide PS Initial or Prolonged Olanzapine SS Divalproex C 24-Jun-2005 12:19 PM Page: 2034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3976782-XReport Type:Expedited (15-DaCompany Report #USA020819428 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) Company (Olanzapine) PS Representative Lithium C Actos (Pioglitazone) C Glucophage - Slow Release (Metformin Hydrochloride) C Prilosec (Omeprazole) C Prevacid (Lansoprazole) C Hydrochlorothiazide C Relafen (Nabumetone) C Celebrex (Celecoxib) C Ibuprofen C Rynatan C Detrol (Tolterodine L-Tartrate) C Monopril (Fosinopril Sodium) C Synthroid (Levothyroxine Sodium) C Lorazepam C Klaonopin (Clonazepam) C Oxycontin (Oxycodone Hydrochloride) C Neurontin (Gabapentin) C Date:09/17/02ISR Number: 3976785-5Report Type:Expedited (15-DaCompany Report #USA020617533 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Zyprexa-Oral Initial or Prolonged Hiatus Hernia Professional (Olanzapine) Company (Olanzapine) PS Representative Date:09/17/02ISR Number: 3976826-5Report Type:Expedited (15-DaCompany Report #USA020820528 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Zyprexa PS ORAL 20 MG/1 DAY 15 MON Initial or Prolonged Professional Niacin C Company Synthroid C Representative 24-Jun-2005 12:19 PM Page: 2035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3976827-7Report Type:Expedited (15-DaCompany Report #USA020920701 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Zyprexa PS ORAL Infarction Professional Company Representative Date:09/17/02ISR Number: 3976837-XReport Type:Expedited (15-DaCompany Report #USA020920662 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS ORAL Professional Company Representative Date:09/17/02ISR Number: 3976864-2Report Type:Direct Company Report #CTU 176699 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Zyprexa 5mg PS ORAL 5MG PO Q HS Initial or Prolonged Neurontin C Paxil C Ambien C Lasix C Glyburide C Pravachol C Ntg C Insulin 70/30 C Lisinopril C Asa C Glucophage C Date:09/17/02ISR Number: 3976891-5Report Type:Expedited (15-DaCompany Report #US_020987672 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Olanzapine-Oral Other Deep Vein Thrombosis (Olanzapine) PS Obesity Hydrochlorothiazide C Pulmonary Embolism Weight Increased Date:09/17/02ISR Number: 3976892-7Report Type:Expedited (15-DaCompany Report #US_020987773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Neonatal Health Zyprexa-Oral Initial or Prolonged Maternal Drugs Affecting Professional (Olanzapine) Foetus (Olanzapine) PS 38 WK Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C 24-Jun-2005 12:19 PM Page: 2036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin C Date:09/17/02ISR Number: 3976893-9Report Type:Expedited (15-DaCompany Report #US_020987815 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Health Zyprexa-Oral Orthostatic Hypotension Professional (Olanzapine) Company (Olanzapine) PS Representative Date:09/17/02ISR Number: 3976894-0Report Type:Expedited (15-DaCompany Report #US_020987698 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Literature Olanzapine-Oral Initial or Prolonged Discomfort Health (Olanzapine) PS 25 MG/DAY 1 YR Emotional Distress Professional Medication Error Priapism Psychotic Disorder Treatment Noncompliance Date:09/17/02ISR Number: 3976917-9Report Type:Expedited (15-DaCompany Report #USA020819643 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Hospitalization - Non-Insulin-Dependent Professional (Olanzapine) Initial or Prolonged Dizziness Company (Olanzapine) PS 10 MG/1 AT Other Loss Of Consciousness Representative BEDTIME Myocardial Infarction Vitamin E C Prolixin Decanoate (Fluphenazine Decanoate) C Date:09/17/02ISR Number: 3976958-1Report Type:Expedited (15-DaCompany Report #GBS020811275 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Foreign Zyprexa-Oral Initial or Prolonged Anxiety Health (Olanzapine) Blister Professional (Olanzapine) PS Depression Other Zyprexa-Oral Insomnia (Olanzapine) Liver Function Test (Olanzapine) SS 400 MG/DAY Abnormal Paracetamol C Overdose Zopiclone C Rash Valproate Sodium C Rash Papular Weight Increased 24-Jun-2005 12:19 PM Page: 2037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3976977-5Report Type:Expedited (15-DaCompany Report #EWC020932255 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Hexaglucon (Glibenclamide) C Lithium "Oba" (Lithium Carbonate) C Date:09/17/02ISR Number: 3976983-0Report Type:Expedited (15-DaCompany Report #EWC020932257 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Apathy Health (Olanzapine) Other Aspiration Professional (Olanzapine) PS 5 MG/DAY Cardiomegaly Other Alprazolam "Nm Delusion Pharma" (Alprazolam) C Extrapyramidal Disorder Fear Hyperhidrosis Intentional Misuse Intentional Self-Injury Lung Infiltration Pneumonia Salivary Hypersecretion Date:09/17/02ISR Number: 3976986-6Report Type:Expedited (15-DaCompany Report #CA_020905342 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Phlebitis Foreign Zyprexa-Oral Other Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG DAY Other Date:09/17/02ISR Number: 3976993-3Report Type:Expedited (15-DaCompany Report #DE_020809527 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 5 MG/DAY Aminotransferase Other Fluanxol Increased (Flupentixol Blood Bilirubin Increased Dihydrochloride) C Gamma-Glutamyltransferase Akineton Retard Increased (Biperiden Hydrochloride) C Truxal (Chlorprothixene Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3977311-7Report Type:Expedited (15-DaCompany Report #DE_020809473 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-Oral Initial or Prolonged Drug Level Increased Health (Olanzapine) Neuroleptic Malignant Professional (Olanzapine) PS 10 MG/DAY Syndrome Company Lithium C Pneumonia Representative Renal Failure Other Date:09/17/02ISR Number: 3977315-4Report Type:Expedited (15-DaCompany Report #DE_020308199 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Communication Disorder Foreign Zyprexa-Oral Hospitalization - General Physical Health Health (Olanzapine) Initial or Prolonged Deterioration Professional (Olanzapine) PS 5 MG/DAY Hypotension Other Sifrol (Pramipexole Infection Dihydrochloride) C Lung Infiltration Nacom C Pancytopenia Arelix (Piretanide) C Pyrexia Somnolence Date:09/17/02ISR Number: 3977351-8Report Type:Expedited (15-DaCompany Report #EWC020932214 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Foreign Zyprexa-Oral Initial or Prolonged Sepsis Health (Olanzapine) Professional (Olanzapine) PS Other Topamax (Topiramate) C Date:09/17/02ISR Number: 3977352-XReport Type:Expedited (15-DaCompany Report #EWC020932249 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Foreign Zyprexa-Rapid-Acting Overdose Other Im (Olanzapine) PS 20 MG/IN THE EVENING Imovane (Zopiclone) C Propavan (Propiomazine) C Date:09/17/02ISR Number: 3977380-4Report Type:Expedited (15-DaCompany Report #US_020684888 Age:24 YR Gender:Male I/FU:F Outcome PT Life-Threatening Depressed Level Of Other Consciousness Dialysis Intentional Misuse Loss Of Consciousness Pneumonia Aspiration Renal Failure Rhabdomyolysis Suicide Attempt 24-Jun-2005 12:19 PM Page: 2039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Artane Representative (Trihexyphenidyl Other Hydrochloride) C Rohypnol (Flunitrazepam) C Date:09/17/02ISR Number: 3977447-0Report Type:Expedited (15-DaCompany Report #US_020987707 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Eruption Foreign Olanzapine Eosinophil Count Health (Olanzapine) PS ORAL 10 MG/DAY Increased Professional Vegetamin A C Erythema Company Depas Liver Disorder Representative (Etizolam) C Oedema Peripheral Other White Blood Cell Count Increased Date:09/17/02ISR Number: 3977563-3Report Type:Expedited (15-DaCompany Report #US_020987637 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa-Oral Initial or Prolonged Consciousness Health (Olanzapine) Overdose Professional (Olanzapine) PS 14 DSG Company FORM/DAY Representative Depas (Etizolam) C Other Date:09/17/02ISR Number: 3977565-7Report Type:Expedited (15-DaCompany Report #US_020987720 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Oral Haematemesis Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Lodopin (Zotepine) C Representative Rohypnol Other (Flunitrazepam) C Tinelac (Sennoside A+B) C Pyrethia (Promethazine Hydrochloride) C Hirnamin (Levomepromazine) C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride) C Lexotan (Bromazepam) C 24-Jun-2005 12:19 PM Page: 2040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Artane (Trihexyphenidyl Hydrochloride) C Valerin (Valproate Sodium) C Amaryl (Glimepiride) C Date:09/17/02ISR Number: 3977592-XReport Type:Expedited (15-DaCompany Report #USA020820553 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Darvocet-. Initial or Prolonged Abnormal Professional (Propoxyphene Other Company Hydrochloride) PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS Advair C Trazodone C Paxil (Paroxetine Hydrochloride) C Dyazide C Prevacid (Lansoprazole) C Aciphex (Rabeprazole Sodium) C Date:09/17/02ISR Number: 3978559-8Report Type:Expedited (15-DaCompany Report #HQ4130110SEP2002 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Health Premarin (Conjugated Initial or Prolonged Dizziness Professional Estrogens, Tablet) PS ORAL 0.625 MG Other Hepatitis Other DAILY ORAL 68 DAY Isoniazid (Isoniazid) SS 300 MG DAILY 221 DAY Olanzapine (Olanzapine, ) SS 5 MG AS NEEDED Pyridoxine Hydrochloride (Pyridoxine Hydrochloride, ) SS 50 MG DAILY 221 DAY Rifampicin (Rifampicin, ) SS 600 MG DAILY 221 DAY Zantac (Ranitidine Hydrochloride, ) SS 300 MG DAILY 37 DAY Date:09/17/02ISR Number: 3979101-8Report Type:Expedited (15-DaCompany Report #GBS020911421 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Olanzapine-Oral Health (Olanzapine) PS ORAL Professional Aspirin (Aspirin Other (Acetylsaliculic Acid)) SS 24-Jun-2005 12:19 PM Page: 2041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3979102-XReport Type:Expedited (15-DaCompany Report #GBS020911411 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Stem Ischaemia Foreign Zyprexa Oral Myocardial Infarction Health (Olanzapine) PS ORAL 10 MG Professional Procyclidine C Other Clopixol (Zuclopenthixol Decanoate) C Priadel (Lithium Carbonate) C Diazepam C Date:09/17/02ISR Number: 3979103-1Report Type:Expedited (15-DaCompany Report #DE_020909604 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokinesia Foreign Zyprexa Oral Oedema Health Phlebitis Professional (Olanzapine) PS ORAL 10 MG/DAY Other Kemadrin (Procyclidine Hydrochloride) C Risperdal (Risperidone) C Seropram (Citalopram Hydrobromide) C Clorazepate Dipotassium C Date:09/18/02ISR Number: 3977667-5Report Type:Direct Company Report #CTU 176767 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Cholesterol Zyprexa 20mg PS ORAL 20MG QD ORAL Required Increased Intervention to Blood Triglycerides Prevent Permanent Increased Impairment/Damage Diabetes Mellitus Date:09/19/02ISR Number: 3977710-3Report Type:Expedited (15-DaCompany Report #B0279489A Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Paxil (Paroxetine Health Hydrochloride) PS Professional Olanzapine (Olanzapine) SS Trazodone (Trazodone) SS Date:09/19/02ISR Number: 3977725-5Report Type:Expedited (15-DaCompany Report #B0279408A Age:39 YR Gender: I/FU:I Outcome PT Report Source Death Completed Suicide Literature Intentional Misuse Health 24-Jun-2005 12:19 PM Page: 2042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Paracetamol (Acetaminophen) PS Paxil (Paroxetine Hydrochloride) SS Olanzapine (Olanzapine) SS Date:09/19/02ISR Number: 3978205-3Report Type:Expedited (15-DaCompany Report #B0279666A Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Literature Lithium Salt Health (Formulation Professional Unknown) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS Date:09/19/02ISR Number: 3978294-6Report Type:Expedited (15-DaCompany Report #A0379981A Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Misuse Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Carbamazepine (Carbamazepine) SS Olanzapine (Olanzapine) SS Date:09/19/02ISR Number: 3978454-4Report Type:Expedited (15-DaCompany Report #A0379990A Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Misuse Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Alprazolam (Alprazolam) SS Olanzapine (Olanzapine) SS Date:09/19/02ISR Number: 3978463-5Report Type:Expedited (15-DaCompany Report #A0379986A Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Misuse Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Olanzapine 24-Jun-2005 12:19 PM Page: 2043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Formulation Unknown) (Olanzapine) SS Clonazepam (Formulation Unknown) (Clonazepam) SS Date:09/19/02ISR Number: 3978504-5Report Type:Direct Company Report #CTU 176860 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Increased Appetite Zyprexa 2.5mg Lilly PS Lilly ORAL 1.25MG BID Intervention to Oedema Peripheral ORAL Prevent Permanent Protein Total Decreased Depakote C Impairment/Damage Weight Increased Prozac C Date:09/20/02ISR Number: 3978130-8Report Type:Direct Company Report #USP 55172 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zytrec PS Pfizer Zyprexa SS Lilly Date:09/22/02ISR Number: 4013043-7Report Type:Periodic Company Report #A119959 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Thiothixene Initial or Prolonged Professional (Tiotixene) PS ORAL ORAL Required Zyprexa (Olanzapine) SS Intervention to Haldol (Haloperidol) SS Prevent Permanent Seroquel (Quetiapine Impairment/Damage Fumarate) SS Date:09/23/02ISR Number: 3980042-0Report Type:Expedited (15-DaCompany Report #NSADSS2002032638 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Fentanyl (Patch) Health (Fentanyl) PS Professional Zolpidem (Zolpidem) SS Olanzapine (Olanzapine) SS Date:09/23/02ISR Number: 3980158-9Report Type:Expedited (15-DaCompany Report #US0205100 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Carbamazepine PS 600 MG Initial or Prolonged Dystonia Literature Olanzapine SS 10 MG 24-Jun-2005 12:19 PM Page: 2044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/02ISR Number: 3980471-5Report Type:Expedited (15-DaCompany Report #US_020987795 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Fluctuation Literature Olanzapine-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) PS 20 MG/DAY 3 YR Other Non-Insulin-Dependent Professional Dizziness Somnolence Weight Increased Date:09/24/02ISR Number: 3980472-7Report Type:Expedited (15-DaCompany Report #USA020920819 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Zyprexa-Oral Initial or Prolonged Weight Increased Professional (Olanzapine) PS Company Representative Date:09/24/02ISR Number: 3980497-1Report Type:Expedited (15-DaCompany Report #US_020684963 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Foreign Zyprexa-Oral Initial or Prolonged Iron Deficiency Anaemia Health (Olanzapine) Other Leukopenia Professional (Olanzapine) PS 10 MG/DAY Renal Cyst Company Levotomin Representative (Levomepromazine Other Maleate) C Rivotril (Clonazepam) C Metoclol (Metoclopramide) C Primperan (Metoclopramide) C Wypax (Lorazepam) C Lendormin (Brotizolam) C Rohypnol (Flunitrazepam) C Date:09/24/02ISR Number: 3980498-3Report Type:Expedited (15-DaCompany Report #US_020987637 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zyprexa-Oral Hospitalization - Consciousness Health (Olanzapine) Initial or Prolonged Intentional Misuse Professional (Olanzapine) PS 14 DSG Suicide Attempt Company FORM/DAY Therapeutic Agent Representative Depas (Etizolam) C Toxicity Other 24-Jun-2005 12:19 PM Page: 2045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/02ISR Number: 3980499-5Report Type:Expedited (15-DaCompany Report #US_020887362 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Purpura Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Company Representative Other Date:09/24/02ISR Number: 3980966-4Report Type:Expedited (15-DaCompany Report #EWC020731861 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Olanzapine-Oral Life-Threatening Syndrome Health (Olanzapine) PS 5 MG 3 DAY Hospitalization - Respiratory Disorder Professional Anti Parkinson C Initial or Prolonged Thrombosis Other Date:09/24/02ISR Number: 3981108-1Report Type:Expedited (15-DaCompany Report #AU_020905429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Central Foreign Zyprexa-Oral Nervous System Anomaly Health (Olanzapine) Maternal Drugs Affecting Professional (Olanzapine) PS Foetus Company Representative Other Date:09/24/02ISR Number: 3981112-3Report Type:Expedited (15-DaCompany Report #US_020987919 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Haemorrhage Foreign Olanzapine-Oral Health (Olanzapine) PS 15 MG/DAY 1 YR Professional Haloperidol C Other Valproate Sodium C Clonazepam C Biperiden C Date:09/24/02ISR Number: 3981113-5Report Type:Expedited (15-DaCompany Report #2002AP02542 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Hypotension Health PO Initial or Prolonged Hypothermia Professional Zyprexa SS ORAL 5 MG DAILY PO Other Pursennid C Akineton C Depas C Efotinon C Landsen C Risumic C Tegretol C Magnesium Oxide C Pantosin C 24-Jun-2005 12:19 PM Page: 2046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Evamyl C Doral C Date:09/24/02ISR Number: 3981131-7Report Type:Expedited (15-DaCompany Report #US_020887033 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Hepatic Function Abnormal Health (Olanzapine) Other Hepatic Steatosis Professional (Olanzapine) PS 10 MG/DAY Hyperlipidaemia Company Impromen Jaundice Representative (Bromperidol) C Malaise Other Tasmolin (Biperiden) C Retching Mevalotin Weight Increased (Pravastatin Sodium) C White Blood Cell Count Levomepromazine C Increased Dalmate (Flurazepam Hydrochloride) C Date:09/24/02ISR Number: 3981132-9Report Type:Expedited (15-DaCompany Report #FR_020701220 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Psychosis Foreign Zyprexa-Oral Death Health (Olanzapine) Drug Level Increased Professional (Olanzapine) PS 30 MG/DAY Medication Error Company Clopixol Pneumonia Aspiration Representative (Zuclopenthixol Somnolence Other Decanoate) C Rivotril (Clonazepam) C Lepticur(Tropatepine Hydrochloride) C Subutex(Buprenorphin e Hydrochloride) C Depakote (Valproate Semisodium) C Date:09/24/02ISR Number: 3981133-0Report Type:Expedited (15-DaCompany Report #EWC020731766 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Torsade De Pointes Foreign Olanzapine-Oral Ventricular Fibrillation Health (Olanzapine) PS ORAL 5 MG/DAY Professional Lanoxin(Digoxin) C Other Lasix (Furosemide) C Date:09/24/02ISR Number: 3981134-2Report Type:Expedited (15-DaCompany Report #US_020886730 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Ulcer Haemorrhage Foreign Olanzapine-Oral Shock Haemorrhagic Study (Olanzapine) PS ORAL 10 MG DAY Health Serenace Professional (Haloperidol) C Other Contomin (Chlorpromazine 24-Jun-2005 12:19 PM Page: 2047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Tegretol (Carbamazepine) C Akineton (Biperiden Hydrochloride) C Eurodin (Estazolam) C Rohypnol (Flunitrazepam) C Vegetamin A C Date:09/24/02ISR Number: 3981135-4Report Type:Expedited (15-DaCompany Report #FR_020901405 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa-Oral Initial or Prolonged Syndrome Health (Olanzapine) Rhabdomyolysis Professional (Olanzapine) PS ORAL 1 DSG Other FORM/DAY Kardegic (Acetylsalicylate Lysine) C Coaprovel C Date:09/24/02ISR Number: 3981137-8Report Type:Expedited (15-DaCompany Report #EWC020932294 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Therapeutic Agent Foreign Olanzapine-Oral Toxicity Health (Olanzapine) PS ORAL 10 MG/DAY Treatment Noncompliance Professional Valproic Acid C Company Diazepam C Representative Other Date:09/24/02ISR Number: 3981138-XReport Type:Expedited (15-DaCompany Report #DE_020909603 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS ORAL 5 MG/DAY Other Date:09/24/02ISR Number: 3981140-8Report Type:Expedited (15-DaCompany Report #CA_020905345 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Olanzapine -Oral Health (Olanzapine) PS ORAL 20 MG/DAY Professional Other 24-Jun-2005 12:19 PM Page: 2048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/02ISR Number: 3981284-0Report Type:Direct Company Report #CTU 177053 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Zyprexa 5ml PS Sedation Somnolence Date:09/24/02ISR Number: 3981532-7Report Type:Expedited (15-DaCompany Report #US_020987863 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Health Zyprexa-Oral Professional (Olanzapine)(Olanzap Company ine) PS Representative Date:09/24/02ISR Number: 3981533-9Report Type:Expedited (15-DaCompany Report #US_020987862 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa-Oral Prolonged Professional (Olanzapine)(Olanzap Company ine) PS Representative Date:09/26/02ISR Number: 3981481-4Report Type:Direct Company Report #CTU 177263 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Hyperosmolar Zyprexa 10mg Lilly PS Lilly ORAL 30MG DAILY Hospitalization - Coma ORAL Initial or Prolonged Encephalopathy Depakote 500mg Required Abbott SS Abbott ORAL 1500MG DAILY Intervention to ORAL Prevent Permanent Impairment/Damage Date:09/30/02ISR Number: 3983339-3Report Type:Direct Company Report #CTU 177558 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Olanzapine -Zyprexa- PS ORAL ORAL Initial or Prolonged Coma Electrocardiogram Qt Prolonged Hypotension Date:10/01/02ISR Number: 3983047-9Report Type:Expedited (15-DaCompany Report #GBS020911421 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine Intentional Misuse Health (Olanzapine) PS ORAL Treatment Noncompliance Professional Aspirin Other (Acetylsalicylic Acid)) SS 24-Jun-2005 12:19 PM Page: 2049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report . . . . . C Date:10/01/02ISR Number: 3983106-0Report Type:Expedited (15-DaCompany Report #DE_020909664 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:10/01/02ISR Number: 3983108-4Report Type:Expedited (15-DaCompany Report #EWC020731896 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Spontaneous Foreign Olanzapine-Oral Anxiety Health (Olanzapine) PS 10 MG/DAY Complications Of Maternal Professional Exposure To Therapeutic Other Drugs Haemorrhage Maternal Drugs Affecting Foetus Restlessness Stillbirth Date:10/01/02ISR Number: 3983303-4Report Type:Expedited (15-DaCompany Report #US_020483405 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Study (Olanzapine) PS 15 MG DAY Other Anger Health Wintermin Blood Bilirubin Increased Professional (Chlorpromazine C-Reactive Protein Other Hydrochloride) C Increased Diazepam C Enterocolitis Artane Gamma-Glutamyltransferase (Trihexyphenidyl Increased Hydrochloride) C Intestinal Obstruction Pyrethia Irritability (Promethazinehydroch Pyrexia loride) C Pursennid (Senna Leaf) C Magnesium Oxide C Biofermin R (Streptococcus Faecalis) C Simvastatin C Gaster (Famotidine) C Date:10/01/02ISR Number: 3983477-5Report Type:Expedited (15-DaCompany Report #US_020887038 Age:69 YR Gender:Female I/FU:F Outcome PT Other Abdominal Pain Diabetes Mellitus 24-Jun-2005 12:19 PM Page: 2050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hunger Increased Appetite Pyrexia Report Source Product Role Manufacturer Route Dose Duration Weight Increased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Lendormin Representative (Brotizolam) C Other Date:10/01/02ISR Number: 3983478-7Report Type:Expedited (15-DaCompany Report #US_020887549 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 15 MG/DAY Aspartate Professional Wypax (Lorazepam) C Aminotransferase Company Rohypnol Increased Representative (Flunitrazepam) C Blood Lactate Other Chlorpromazine C Dehydrogenase Increased Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Pyrexia Date:10/01/02ISR Number: 3983479-9Report Type:Expedited (15-DaCompany Report #US_020987707 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Foreign Olanzapine-Oral Dehydrogenase Increased Health (Olanzapine) PS 10 MG/DAY Drug Eruption Professional Vegetamin A C Eosinophil Count Company Depas (Etizolam) C Increased Representative Ldh, Lactic Erythema Other Dehydrogenase C Excoriation Hepatic Function Abnormal Oedema Peripheral White Blood Cell Count Increased Date:10/01/02ISR Number: 3983480-5Report Type:Expedited (15-DaCompany Report #EWC020731861 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Olanzapine-Oral Life-Threatening Syndrome Health (Olanzapine) PS 5 MG 3 DAY Hospitalization - Obstructive Airways Professional Anti Parkinson C Initial or Prolonged Disorder Other Procedural Complication Respiratory Disorder 24-Jun-2005 12:19 PM Page: 2051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 3983481-7Report Type:Expedited (15-DaCompany Report #US_020685375 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Decreased Activity Study (Olanzapine) PS 20 MG DAY Hallucination Health Perospirone Hcl Platelet Count Decreased Professional Hydrate "Lullan C Tremor Other Amoban (Zopliclone) C Orap (Pimozide) C Depas (Etizolam) C Risperdal (Risperidone) C Akineton (Biperiden Hydrochloride) C Date:10/01/02ISR Number: 3983495-7Report Type:Expedited (15-DaCompany Report #EWC020932377 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Murder Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Rivotril (Clonazepam) C Xanax (Alprazolam) C Date:10/01/02ISR Number: 3983497-0Report Type:Expedited (15-DaCompany Report #FR_020901453 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Representative Other Date:10/01/02ISR Number: 3983498-2Report Type:Expedited (15-DaCompany Report #DE_020909646 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa-Oral Hospitalization - Difficulty In Walking Health (Olanzapine) Initial or Prolonged Dyspnoea Professional (Olanzapine) PS 20 MG/DAY Generalised Oedema Other Hyponatraemia Date:10/01/02ISR Number: 3983507-0Report Type:Expedited (15-DaCompany Report #US_020987573 Age:70 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Alkaline 24-Jun-2005 12:19 PM Page: 2052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphatase Increased Blood Lactate Dehydrogenase Increased Liver Disorder Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Hirnamin Representative (Levomepromazine) C Other Rohypnol (Flunitrazepam) C Depas (Etizolam) C Pyrethia (Promethazine Hydrochloride) C Flomox (Cefcapene Pivoxil Hydrochloride) C Cravit (Levofloxacin) C Cefmetazon (Cefmetazole Sodium) C Date:10/01/02ISR Number: 3983555-0Report Type:Expedited (15-DaCompany Report #USA020921253 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Zyprexa-Oral Other Pulmonary Embolism Professional (Olanzapine) Company (Olanzapine) PS 20 MG/ DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/ DAY Date:10/01/02ISR Number: 3985045-8Report Type:Expedited (15-DaCompany Report #US_011279183 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Health Zyprexa-Oral Diabetes Mellitus Professional (Olanzapine) Electrocardiogram Qt (Olanzapine) PS 10 MG/1 AT Corrected Interval BEDTIME Prolonged Novolog (Insulin Aspart) C Lantus (Insulin Glargine) C Paxil (Paroxetine Hydrochloride) C Date:10/01/02ISR Number: 3985680-7Report Type:Expedited (15-DaCompany Report #USA020921110 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Consumer Zyprexa-Oral Hip Arthroplasty (Olanzapine) (Olanzapine) PS 5 MG/DAY 24-Jun-2005 12:19 PM Page: 2053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 3985681-9Report Type:Expedited (15-DaCompany Report #US_020988011 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Zyprexa-Oral Initial or Prolonged Coma Professional (Olanzapine) Other Confusional State (Olanzapine) PS 750 MG Depressed Level Of Consciousness Dysarthria Haemorrhage Subcutaneous Hypotonia Hypoxia Implant Site Reaction Nystagmus Pulmonary Embolism Somnolence Spinal Cord Disorder Status Epilepticus Date:10/01/02ISR Number: 3985682-0Report Type:Expedited (15-DaCompany Report #USA020921366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY 2 DAY Representative Oxycontin (Oxycodone Hydrochloride) C Date:10/01/02ISR Number: 3985683-2Report Type:Expedited (15-DaCompany Report #USA020921267 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombocytopenia Health Zyprexa-Oral Hospitalization - White Blood Cell Count Professional (Olanzapine) Initial or Prolonged Decreased Company (Olanzapine) PS 5 MG/DAY 4 WK Representative Date:10/01/02ISR Number: 3985753-9Report Type:Expedited (15-DaCompany Report #USA020921180 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Genital Disorder Female Health Zyprexa-Oral Initial or Prolonged Neutropenia Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY 16 MON Representative Date:10/01/02ISR Number: 4008709-9Report Type:Periodic Company Report #1998UW47645 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Literature Seroquel PS ORAL 200 MG BID PO Intervention to White Blood Cell Count Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Decreased Professional PO Impairment/Damage Olanzapine SS 10 MG DAILY Risperdal C 24-Jun-2005 12:19 PM Page: 2054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008783-XReport Type:Periodic Company Report #2002UW00348 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG HS PO Intervention to Professional Zyprexa SS 7.5 MG HS Prevent Permanent Zyprexa SS 10 MG HS Impairment/Damage Effexor SS 150 MG Effexor SS 75 MG Neurontin C Humalin C Glucovance C Vitamin E C Toprol C Norvasc C Ultram C Prevacid C Mellaril C Date:10/01/02ISR Number: 4027251-2Report Type:Periodic Company Report #2002AP00323 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Literature Quetiapine PS 25 MG DAILY 6 DAY Hospitalization - Suicide Attempt Health Quetiapine SS 100 MG DAILY Initial or Prolonged Professional Quetiapine SS 200 MG DAILY 4 MON Required Olanzapine SS 10 MG DAILY 3 YR Intervention to Olanzapine SS 20 MG DAILY Prevent Permanent Olanzapine SS 30 MG DAILY Impairment/Damage Valproate C Clonazepam C Haloperidol C Date:10/02/02ISR Number: 3984370-4Report Type:Direct Company Report #CTU 177797 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Insomnia Propranolol PS 15MG/D Hospitalization - Mental Disorder Haldolial X 2 SS 10 MG Initial or Prolonged Benztropine SS Disability Zyprexa SS 5 MG/D Other Diabetes Meds C Required Intervention to Prevent Permanent Impairment/Damage Date:10/02/02ISR Number: 3985522-XReport Type:Direct Company Report #CTU 177721 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Olanzapine PS ORAL 35MG QD ORAL 24-Jun-2005 12:19 PM Page: 2055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3985524-3Report Type:Direct Company Report #CTU 177722 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anticholinergic Syndrome Olanzapine PS Chills Amitriptyline SS Coma Convulsion Dry Skin Electrocardiogram Qt Corrected Interval Shortened Feeling Cold Mental Status Changes Salivary Hypersecretion Sinus Tachycardia Tremor Urinary Incontinence Date:10/02/02ISR Number: 3985529-2Report Type:Direct Company Report #CTU 177726 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa 2.5mg Eli Initial or Prolonged Phosphokinase Increased Lilly PS Eli Lilly ORAL 2.5MG BID Blood Creatine ORAL Phosphokinase Mb Zyprexa 7.5mg Eli Increased Lilly SS Eli Lilly ORAL 7.5MG HS ORAL Blood Creatinine Increased Blood Urea Increased Body Temperature Increased Dehydration Depressed Level Of Consciousness Lethargy Date:10/03/02ISR Number: 3985221-4Report Type:Expedited (15-DaCompany Report #2002058575 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Connective Tissue Literature Zyrtec (Tablets) Disorder Health (Cetirizine Dizziness Professional Hydrochloride) PS ORAL ORAL Ill-Defined Disorder Zyprexa (Olanzapine) SS ORAL ORAL Loss Of Consciousness Medication Error Pulmonary Oedema Date:10/03/02ISR Number: 3985531-0Report Type:Direct Company Report #CTU 178920 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10MG 24-Jun-2005 12:19 PM Page: 2056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/02ISR Number: 3986943-1Report Type:Expedited (15-DaCompany Report #2002-DE-02246GD(0) Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Literature Methadone Required Torsade De Pointes (Methadone) PS 1000 MG, NR 12 MON Intervention to Olanzapine Prevent Permanent (Olanzapine) SS Impairment/Damage Date:10/03/02ISR Number: 3987372-7Report Type:Expedited (15-DaCompany Report #02P-008-0200591-00 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Epilim Tablets Hospitalization - Condition Aggravated Health (Sodium Valproate) Initial or Prolonged Delirium Professional (Sodium Valproate) Hallucination, Auditory Other (Sodium Valproate) PS ORAL 10 GM, ONCE, Intentional Misuse ORAL Olanzapine SS ORAL 2.5 GM, ONCE, ORAL Haloperidol SS ORAL 100 MG, ONCE, ORAL Trifeme C Bekunis C Date:10/03/02ISR Number: 3987410-1Report Type:Expedited (15-DaCompany Report #2002058781 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fluid Retention Foreign Zoloft (Sertraline) PS Initial or Prolonged Health Olanzapine SS Professional Diuretics SS Date:10/03/02ISR Number: 3987991-8Report Type:Expedited (15-DaCompany Report #2002-DE-02258GD(0) Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Literature Methadone Required Hypokalaemia (Methadone) PS 65 MG 2 MON Intervention to Syncope Olanzapine Prevent Permanent Torsade De Pointes (Antipsychotics) SS Impairment/Damage Alcohol (Ethanol) SS Date:10/07/02ISR Number: 3985806-5Report Type:Direct Company Report #CTU 178024 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Olanzapine PS ORAL 10MG PO QAM, Disseminated 20MG PO HS Intravascular Coagulation Atenolol C Hypertension Heldol Deconate C Toxicologic Test Abnormal Benztropine C 24-Jun-2005 12:19 PM Page: 2057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/02ISR Number: 3986911-XReport Type:Direct Company Report #CTU 178161 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Lamotrigine PS Initial or Prolonged Olanzapine SS Date:10/07/02ISR Number: 3990432-8Report Type:Direct Company Report #CTU 178066 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Olanzapine PS ORAL 10MG PO QAM ; Hypertension 20MG PO HS Sudden Death Atenolol C Toxicologic Test Abnormal Haldol Deconate C Benztropine C Date:10/07/02ISR Number: 3990434-1Report Type:Direct Company Report #CTU 178067 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Spinal Disorder Zyprexa 2.5mg PS ORAL 2.5MG QHS PO Date:10/08/02ISR Number: 3986313-6Report Type:Direct Company Report #CTU 178182 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Olanzapine PS ORAL 10MG PO QAM; Hypertension 20MG PO HS Toxicologic Test Abnormal Atenolol C Haldol Deconate C Benztropine C Date:10/08/02ISR Number: 3989856-4Report Type:Expedited (15-DaCompany Report #02P-163-0201355-00 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene) Professional (Valproic Acid) (Valproic Acid) PS Olanzapine SS Gabapentin SS Date:10/08/02ISR Number: 3989864-3Report Type:Expedited (15-DaCompany Report #02P-163-0201330-00 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene ) Professional (Valproic Acid) (Valproic Acid) PS Acetylsalicylic Acid SS Olanzapine SS 24-Jun-2005 12:19 PM Page: 2058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/02ISR Number: 3990523-1Report Type:Expedited (15-DaCompany Report #2002090023 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Foreign Doral (Quazepam) Hypotension Health Tablets PS ORAL 15 MG/D, PO Hypothermia Professional Quetiapine Fumarate SS ORAL 200 MG/D, PO Memory Impairment Olanzapine SS ORAL 5 MG/D PO Speech Disorder Etizolam SS ORAL 3 MG/D PO Clonazepam SS ORAL 1 MG/D PO Carbamazepine SS ORAL 150 MG/D PO Lormetazepam SS ORAL 1 MG/D PO Sennosides C Biperiden Hcl C Etilefrine Hcl C Amezinium Metilsulfate C Magnesium Oxide C Pantethine C Date:10/08/02ISR Number: 3991368-9Report Type:Expedited (15-DaCompany Report #DE_000302217 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Health Dipiperon Professional (Pipamperone) C Other Dociton (Propanolol Hydrochloride) C Date:10/09/02ISR Number: 3987235-7Report Type:Direct Company Report #CTU 178341 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Zyprexa Lilly PS Lilly ORAL 2.5-10MG QD Initial or Prolonged ORAL Date:10/09/02ISR Number: 3987323-5Report Type:Direct Company Report #CTU 178438 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Zyprexa 2.5 Mg (Ely Initial or Prolonged Difficulty In Walking Lilli) PS Ely Lilli ORAL 1 PILL DAILY Other Fall ORAL 2 YR Lordosis Date:10/09/02ISR Number: 3987557-XReport Type:Direct Company Report #CTU 178323 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Olanzapine PS ORAL 10 MG PO Olanzapine Tab SS ORAL 10MG PO 24-Jun-2005 12:19 PM Page: 2059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3988240-7Report Type:Direct Company Report #CTU 178291 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Olanzepine PS ORAL 20 MG, 10 MG Intervention to BID ORAL Prevent Permanent Diazepam C Impairment/Damage Trihexyphenidyl Hcl C Quetiapine Fumarate C Potassium Chloride C Potassium Chloride (K-Dur) C Date:10/09/02ISR Number: 3989669-3Report Type:Direct Company Report #CTU 178331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec 10 Mg Pfizer PS Pfizer ORAL 10 MG AT BEDTIME ORAL Zyprexa 10 Mg Eli Lilly SS Eli Lilly ORAL 10 MG AT BETIME ORAL Date:10/09/02ISR Number: 3990556-5Report Type:Expedited (15-DaCompany Report #US_020988238 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Company Hiberna Increased Representative (Promethazine Fatigue Other Hydrochloride) C Lexotan (Bromazepam) C Pursennid (Senna Leaf) C Magnesium Oxide C Silece (Flunitrazepam) C Vegetamin A C Date:10/09/02ISR Number: 3990572-3Report Type:Expedited (15-DaCompany Report #CA_020905391 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:10/09/02ISR Number: 3990574-7Report Type:Expedited (15-DaCompany Report #CA_020905386 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Metrorrhagia Foreign Health 24-Jun-2005 12:19 PM Page: 2060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG Estrogen C Progesterone C Date:10/09/02ISR Number: 3990575-9Report Type:Expedited (15-DaCompany Report #EWC020932494 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Purpura Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Other Lithium C Date:10/09/02ISR Number: 3990576-0Report Type:Expedited (15-DaCompany Report #EWC020932437 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zyprexa-Oral Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS Drugs Other Haemorrhage Maternal Drugs Affecting Foetus Restlessness Stillbirth Unintended Pregnancy Date:10/09/02ISR Number: 3990577-2Report Type:Expedited (15-DaCompany Report #FR_020901476 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiospasm Foreign Zyprexa-Oral Initial or Prolonged Foreign Body Trauma Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Other Effexor (Venlafaxine Hydrochloride) C Valium (Diazepam) C Atarax (Hydroxyzine Hydrochloride) C Date:10/09/02ISR Number: 3990578-4Report Type:Expedited (15-DaCompany Report #FR_020901468 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zyprexa-Oral Pyrexia Health (Olanzapine) Tachypnoea Professional (Olanzapine) PS 10 MG DAY Company Effexor (Venlafaxine Representative Hydrochloride) C Other Xanax (Alprazolam) C 24-Jun-2005 12:19 PM Page: 2061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3990580-2Report Type:Expedited (15-DaCompany Report #GBS020911574 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Olanzapine-Oral Other (Olanzapine) PS Date:10/09/02ISR Number: 3991040-5Report Type:Expedited (15-DaCompany Report #US_020887107 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Olanzapine-Oral Initial or Prolonged Blindness (Olanzapine) PS 10 MG/DAY Disability Brain Damage Other Coma Dementia Depressed Level Of Consciousness Difficulty In Walking Fall General Physical Health Deterioration Intervertebral Disc Protrusion Memory Impairment Pain Speech Disorder Tremor Weight Increased Date:10/09/02ISR Number: 3991041-7Report Type:Expedited (15-DaCompany Report #USA020921709 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa-Oral Cardiovascular Disorder (Olanzapine) Cerebrovascular Accident (Olanzapine) PS 6 YR Constipation Lipitor Oral Intake Reduced (Atorvastatin) C Personality Change Celebrex (Celecoxib) C Singulair (Montelukast Sodium) C Norvasc (Amlodipine Besilate) C Plavix (Clopidogrel Sulfate) C Aspirin "Bayer" (Acetylsalicylic Acid) C Imdur (Isosorbide Mononitrate) C Sinemet C Stool Softener (Docusate Sodiuim) C Paxil (Paroxetine Hydrochloride) C Xanax (Alprazolam) C Timoptic (Timolol Maleate) C 24-Jun-2005 12:19 PM Page: 2062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3991042-9Report Type:Expedited (15-DaCompany Report #USA020921663 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS Representative Date:10/09/02ISR Number: 3991043-0Report Type:Expedited (15-DaCompany Report #US_020988316 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Literature Olanzapine-Oral Initial or Prolonged Blood Pressure Health (Olanzapine) PS 10MG Fluctuation Professional Sertraline C Body Temperature Paroxetine C Increased Alprazolam C Catatonia Haloperidol C Cerebral Cyst Coma Drug Ineffective Electroencephalogram Abnormal Heart Rate Increased Metabolic Encephalopathy Neuroleptic Malignant Syndrome Oral Intake Reduced Sedation Urinary Incontinence Urinary Tract Infection Date:10/09/02ISR Number: 3991300-8Report Type:Expedited (15-DaCompany Report #DE_020909603 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatosis Foreign Zyprexa-Oral Exanthem Health (Olanzapine) Left Ventricular Failure Professional (Olanzapine) PS 5 MG/DAY Other Torasemid C Ramipril C Ass C Insulin C Date:10/09/02ISR Number: 3991302-1Report Type:Expedited (15-DaCompany Report #US_020987919 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Haemorrhage Foreign Olanzapine-Oral Health (Olanzapine) PS 15 MG/DAY 1 YR Professional Haloperidol C Other Valproate Sodium C Clonazepam C Biperiden C 24-Jun-2005 12:19 PM Page: 2063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3991305-7Report Type:Expedited (15-DaCompany Report #US_020987637 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zyprexa-Oral Hospitalization - Consciousness Health (Olanzapine) Initial or Prolonged Drug Toxicity Professional (Olanzapine) PS 14 DSG Overdose Company FORM/DAY Suicide Attempt Representative Depas (Etizolam) C Other Date:10/09/02ISR Number: 3991886-3Report Type:Expedited (15-DaCompany Report #US_020887033 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Blood Triglycerides Professional (Olanzapine) PS 10 MG / DAY Increased Company Impromen Condition Aggravated Representative (Bromperidol) C Hepatic Function Abnormal Other Tasmolin (Biperiden) C Hepatic Steatosis Mevalotin Hyperlipidaemia (Pravastatin Sodium) C Jaundice Levomepromazine C Malaise Dalmate (Flurazepam Retching Hydrochloride) C Weight Increased White Blood Cell Count Increased Date:10/09/02ISR Number: 3991890-5Report Type:Expedited (15-DaCompany Report #US_020886789 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine)(Olanzap Aspartate Professional ine) PS Aminotransferase Company Wintermin Increased Representative (Chlorpromazine Blood Creatine Other Hydrochloride) C Phosphokinase Increased Hirnamin Crush Syndrome (Levomepromazine) C Depressed Level Of Benzalin Consciousness (Nitrazepam) C Overdose Pyrethia (Promethazine Hydrochloride) C Date:10/09/02ISR Number: 3991946-7Report Type:Expedited (15-DaCompany Report #USA020819827 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Zyprexa Initial or Prolonged Hallucination, Visual Professional Zydis-Dispersible Overdose (Olanzapine) Weight Decreased (Olanzapine) PS 35 MG/DAY 3 YR Chloral Hydrate C Multivitamin And Mineral Supplement C 24-Jun-2005 12:19 PM Page: 2064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3991948-0Report Type:Expedited (15-DaCompany Report #USA020110526 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa PS 1.25 MG/AT Initial or Prolonged Biopsy Bone Marrow Health BEDTIME Abnormal Professional Multivitamin C Blood Iron Increased Chest Pain Constipation Decreased Activity Depression Dyspnoea Exertional Eosinophilia Hypochromic Anaemia Liver Function Test Abnormal Oedema Peripheral Platelet Count Abnormal Rash Reticulocyte Count Decreased Temperature Intolerance White Blood Cell Count Abnormal Date:10/09/02ISR Number: 3991951-0Report Type:Expedited (15-DaCompany Report #US_020988011 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catheter Related Health Zyprexa-Oral Initial or Prolonged Complication Professional (Olanzapine) Other Clonic Convulsion (Olanzapine) PS ORAL 750 MG Coma Confusional State Convulsion Drug Level Increased Dysarthria Generalised Non-Convulsive Epilepsy Haemorrhage Subcutaneous Hypotonia Hypoxia Medication Error Nystagmus Pulmonary Embolism Somnolence Status Epilepticus Date:10/09/02ISR Number: 3991990-XReport Type:Expedited (15-DaCompany Report #USA020921645 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/2 DAY Representative 24-Jun-2005 12:19 PM Page: 2065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3992174-1Report Type:Expedited (15-DaCompany Report #USA020921652 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa Oral Initial or Prolonged Dyspnoea Professional (Olanzapine) Fall Company (Olanzapine) PS Renal Failure Acute Representative Rhabdomyolysis Date:10/10/02ISR Number: 3991751-1Report Type:Expedited (15-DaCompany Report #USA020921239 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gingival Bleeding Health Zyprexa PS Professional Company Representative Date:10/10/02ISR Number: 3992166-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU08140 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril (Clozapine) Completed Suicide Study Tablet PS ORAL 400 MG/DAY, Overdose Health ORAL Professional Olanzapine Other (Olanzapine) SS Haloperidol (Haloperidol) SS Metazapine () SS Clonidine Hydrochloride (Clonidine Hyrdochloride) SS Date:10/11/02ISR Number: 3991684-0Report Type:Direct Company Report #CTU 178588 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Insipidus Depakote PS 26.5G Hospitalization - Intentional Misuse (OVERDOSE) Initial or Prolonged Loss Of Consciousness Zyprexa SS 230MG(OVERDOS Required Medication Error E) Intervention to Haloperidol Im C Prevent Permanent Depo-Provera C Impairment/Damage Date:10/15/02ISR Number: 3991794-8Report Type:Direct Company Report #CTU 178673 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Zyprexa 15mg Lilly PS Lilly ORAL 15 MG HS ORAL Initial or Prolonged Syndrome Ativan C Mvi C Lopressor C Zocor C Depakote C 24-Jun-2005 12:19 PM Page: 2066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colace C Vitamin E C Trileptal C Date:10/15/02ISR Number: 3994014-3Report Type:Direct Company Report #CTU 178612 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gait Disturbance Zyprexa PS ORAL 30 MG PO QD Hospitalization - Hyperglycaemia Risperdal SS ORAL 3 MG PO BID Initial or Prolonged Hyperkalaemia Lorazepam C Required Hyponatraemia Depakote C Intervention to Mental Status Changes Den Vk C Prevent Permanent Renal Failure Impairment/Damage Somnolence Urinary Incontinence Date:10/16/02ISR Number: 3992716-6Report Type:Direct Company Report #CTU 178878 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa 7.5mg Lilly PS Lilly ORAL 7.5MG BID PO Asa C Motrin C Prevacid C Tylenol C Maalox Plus C Milk Of Magnesia C Date:10/16/02ISR Number: 3993257-2Report Type:Expedited (15-DaCompany Report #US_021088523 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Health Zyprexa-Oral Intentional Misuse Professional (Olanzapine) Suicide Attempt (Olanzapine) PS Zoloft (Sertraline Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Trazodone C Date:10/16/02ISR Number: 3993671-5Report Type:Expedited (15-DaCompany Report #EWC021032564 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bile Duct Obstruction Foreign Zyprexa-Oral Initial or Prolonged Cholelithiasis Health (Olanzapine) Liver Function Test Professional (Olanzaine) PS 10 MG/DAY Abnormal Company Urinary Bladder Atrophy Representative Other 24-Jun-2005 12:19 PM Page: 2067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3993673-9Report Type:Expedited (15-DaCompany Report #EWC021032541 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subdural Haematoma Foreign Olanzapine-Oral Initial or Prolonged Syncope Study (Olanzapine) PS 10 MG Health Colme Professional (Chloramphenicol Other Palmitate) C Date:10/16/02ISR Number: 3993675-2Report Type:Expedited (15-DaCompany Report #EWC021032567 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Foreign Olanzapine-Oral Neutrophil Count Health (Olanzapine) PS 10 MG/DAY Increased Professional Pyrexia Other White Blood Cell Count Increased Date:10/16/02ISR Number: 3993678-8Report Type:Expedited (15-DaCompany Report #EWC020932530 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Transplant Foreign Olanzapine-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) PS 10 MG/DAY A Professional FEW MONTHS Other Nifedipin C Paroxetin (Paroxetine) C Lorazepam C Omeprazole C Atenolol C Sulfamethoxazole W/Trimethoprim C Pethidine C Prednison (Prednisone) C Mycophenolate Mofetil C Sirolimus C Tramadol C Date:10/16/02ISR Number: 3993681-8Report Type:Expedited (15-DaCompany Report #FR_021001498 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other 24-Jun-2005 12:19 PM Page: 2068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3993683-1Report Type:Expedited (15-DaCompany Report #FR_020901489 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arterial Injury Foreign Zyprexa-Oral Initial or Prolonged Depression Health (Olanzapine) Other Injury Professional (Olanzapine) PS 5 MG/DAY Insomnia Other Prozac-Oral Mania (Fluoxetine) Suicide Attempt (Fluoxetine Hydrochloride) SS Teralithe (Lithium Carbonate) C Seropram (Citalopram Hydrobromide) C Prothiaden (Dosulepin) C Xanax (Alprazolam) C Date:10/16/02ISR Number: 3993736-8Report Type:Expedited (15-DaCompany Report #USA020921779 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Other Pneumonia (Olanzapine) PS 20 MG/DAY 3 YR Depakote (Valproate Semisodium) C Date:10/16/02ISR Number: 3993739-3Report Type:Expedited (15-DaCompany Report #USA020921791 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Consumer Zyprexa-Oral Initial or Prolonged Dizziness (Olanzapine) Dysarthria (Olanzapine) PS 10 MG/DAY Ear Congestion Medication Error Muscle Twitching Somnolence Date:10/16/02ISR Number: 3993741-1Report Type:Expedited (15-DaCompany Report #USA021022035 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa-Oral Abnormal Professional (Olanzapine) Renal Failure Company (Olanzapine) PS Representative Date:10/16/02ISR Number: 3993755-1Report Type:Expedited (15-DaCompany Report #USA020921859 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Consumer Zyprexa-Oral Oedema Peripheral (Olanzapine) Somnolence (Olanzapine) PS 10 MG/DAY Weight Increased Depakote (Valproate 24-Jun-2005 12:19 PM Page: 2069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Aspirin C Date:10/16/02ISR Number: 3993757-5Report Type:Expedited (15-DaCompany Report #USA021021963 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aplastic Anaemia Health Zyprexa-Oral Drug Effect Decreased Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY 2 MON Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Vitamin E C Date:10/16/02ISR Number: 3993758-7Report Type:Expedited (15-DaCompany Report #USA021021970 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 15 MG/DAY Sonata(Zaleplon) C Date:10/16/02ISR Number: 3993759-9Report Type:Expedited (15-DaCompany Report #USA021022035 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa-Oral Abnormal Professional (Olanzapine) Renal Failure Company (Olanzapine) PS Representative Date:10/16/02ISR Number: 3993761-7Report Type:Expedited (15-DaCompany Report #USA021021951 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:10/16/02ISR Number: 3993764-2Report Type:Expedited (15-DaCompany Report #US_021088439 Age:58 YR Gender:Male I/FU:I Outcome PT Other Blood Glucose Increased Blood Testosterone Decreased 24-Jun-2005 12:19 PM Page: 2070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocardial Infarction Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 3 YR Date:10/16/02ISR Number: 3994339-1Report Type:Expedited (15-DaCompany Report #FR_020601092 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Hypersensitivity Professional (Olanzapine) PS 7.5 MG/DAY Interstitial Lung Disease Other Restrictive Pulmonary Disease Date:10/16/02ISR Number: 3994345-7Report Type:Expedited (15-DaCompany Report #EWC020932437 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Zyprexa-Oral Exposure To Therapeutic Health (Olanzapine) Drugs Professional (Olanzapine) PS Haemorrhage Other Intra-Uterine Death Maternal Drugs Affecting Foetus Pregnancy Date:10/16/02ISR Number: 3994351-2Report Type:Expedited (15-DaCompany Report #GBS990403152 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Foreign Olanzapine PS Atherosclerosis Health Procyclidine C Drug Level Above Professional Haloperidol C Therapeutic Other Diazepam C Drug Screen Positive Propranolol C Haemorrhage Hepatic Congestion Medication Error Overdose Petechiae Pulmonary Congestion Ventricular Hypertrophy Date:10/16/02ISR Number: 3994463-3Report Type:Expedited (15-DaCompany Report #GBS020911421 Age:43 YR Gender:Male I/FU:F Outcome PT Death Atherosclerosis Completed Suicide Drug Level Above Therapeutic Hepatic Steatosis 24-Jun-2005 12:19 PM Page: 2071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Misuse Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Aspirin (Aspirin Other (Acetylsalicylic Acid)) SS ... C Date:10/16/02ISR Number: 3994495-5Report Type:Expedited (15-DaCompany Report #US_020987573 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Company Hirnamin Increased Representative (Levomepromazine) C Blood Alkaline Other Rohypnol Phosphatase Increased (Flunitrazepam) C Blood Lactate Depas (Etizolam) C Dehydrogenase Increased Pyrethia Gamma-Glutamyltransferase (Promethazine Increased Hydrochloride) C Liver Disorder Flomox (Cefcapene Oliguria Pivoxil Pyrexia Hydrochloride) C Urinary Tract Infection Cravit (Levofloxacin) C Cefmetazon (Cefmetazole Sodium) C Date:10/16/02ISR Number: 3994557-2Report Type:Expedited (15-DaCompany Report #US_020887313 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Olanzapine-Oral Other Back Pain Study (Olanzapine) PS 20 MG/DAY Body Temperature Health Risperdal Increased Professional (Risperidone) C Convulsion Company Tasmolin (Biperiden) C Depressed Level Of Representative Ubretid (Distigmine Consciousness Other Bromide) C Diarrhoea Silece Hyponatraemia (Flunitrazepam) C Nausea Contomin Neuroleptic Malignant (Chlorpromazine Syndrome Hydrochloride) C Polydipsia Depromel Pyrexia (Fluvoxamine) C Rhabdomyolysis Hypen (Etodolac) C Tachycardia Zyloric Urinary Incontinence (Allopurinol) C Water Intoxication Methycobal White Blood Cell Count (Mecobalamin) C Abnormal 24-Jun-2005 12:19 PM Page: 2072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3994584-5Report Type:Expedited (15-DaCompany Report #2002UW13817 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Self-Injury Health Seroquel PS Hospitalization - Overdose Professional Zyprexa SS Initial or Prolonged Physical Assault Ventricular Tachycardia Date:10/16/02ISR Number: 3994592-4Report Type:Expedited (15-DaCompany Report #1998UW47645 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis C Literature Seroquel PS ORAL 200 MG BID PO Intervention to Leukopenia Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Neutropenia Professional PO Impairment/Damage Paranoia Olanzapine SS 10 MG DAILY Physical Assault Risperdal C Psychotic Disorder Thrombocytopenia Date:10/16/02ISR Number: 3994650-4Report Type:Expedited (15-DaCompany Report #USA020110558 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Zyprexa-Oral Initial or Prolonged Imprisonment Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:10/16/02ISR Number: 3994659-0Report Type:Expedited (15-DaCompany Report #USA020921267 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aplastic Anaemia Health Zyprexa-Oral Hospitalization - Bone Marrow Depression Professional (Olanzapine) Initial or Prolonged Pancytopenia Company (Olanzapine) PS 5 MG/DY Other Representative Date:10/16/02ISR Number: 3994662-0Report Type:Expedited (15-DaCompany Report #US_020988011 Age:63 YR Gender:Male I/FU:F Outcome PT Hospitalization - Catheter Related Initial or Prolonged Complication Other Choreoathetosis Clonic Convulsion Coma Confusional State Convulsion Drug Level Increased Dysarthria Extensor Plantar Response Grimacing Haemorrhage Subcutaneous Hyperhidrosis Hypotonia Hypoxia Intentional Misuse 24-Jun-2005 12:19 PM Page: 2073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervous System Disorder Nystagmus Pulmonary Embolism Report Source Product Role Manufacturer Route Dose Duration Somnolence Health Zyperxa -Oral Status Epilepticus Professional (Olanzapine( (Olanzapine) PS 800 MG Lithium C Date:10/16/02ISR Number: 3995619-6Report Type:Expedited (15-DaCompany Report #2002GB02132 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Losec PS ORAL 20 MG QD PO Initial or Prolonged Aplasia Pure Red Cell Health Olanzapine SS ORAL 10 MG QD PO Required Professional Olanzapine SS ORAL 10 MG QD PO Intervention to Other Levosulpiride SS ORAL 25 MG QD PO Prevent Permanent Impairment/Damage Date:10/16/02ISR Number: 3999472-6Report Type:Expedited (15-DaCompany Report #B0282447A Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paxil (Formulation Intentional Misuse Health Unknown) (Paroxetine Professional Hydrochloride) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Trazodone (Formulation Unknown) (Trazodone) SS Date:10/17/02ISR Number: 3991227-1Report Type:Expedited (15-DaCompany Report #322915 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Consumer Valium PS Roche 30 DAY Respiratory Arrest Depakine Chrono C Zyprexa I 456 DAY Heroin I Date:10/17/02ISR Number: 3993770-8Report Type:Direct Company Report #CTU 178905 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Zyprexa 15mg PS Q -DAILY Hospitalization - Pancreatitis Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/02ISR Number: 3997315-8Report Type:Expedited (15-DaCompany Report #002#2#2002-00109 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Reglan Initial or Prolonged Blepharospasm (Metoclopramide Hcl) PS ORAL 10 MG, 4 IN 1 Disability Blood Pressure Increased D, ORAL Bruxism Prochlorperazine - Conversion Disorder Edisylate SS Dizziness Haloperidol SS Dystonia Gabapentin SS Eye Disorder Olanzapine SS Feeling Abnormal Lisinopril C Grimacing Diazepam C Haemangioma Mylanta C Halo Vision Metoprolol C Movement Disorder Heparin C Muscle Spasms Clopidogrel C Nausea Nervousness Nightmare Pain Paraesthesia Photopsia Photosensitivity Reaction Restlessness Strabismus Tardive Dyskinesia Date:10/21/02ISR Number: 3997942-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE03407 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Trileptal Initial or Prolonged Drug Ineffective Consumer Fmi(Oxcabazepine) PS ORAL ORAL; 2450 Drug Interaction Other MG/D (800-450 Epilepsy 200) Fatigue Zyprexa(Olanzapine) SS 7.5 MG/D / Nasal Congestion 2.5 MG /D Keppra (Levetiracetam) C Date:10/21/02ISR Number: 3998786-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE03407 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Trileptal Initial or Prolonged Coordination Abnormal Consumer Fmi(Oxcarbazepine) Drug Ineffective Other Unknown PS ORAL SEE IMAGE Drug Interaction Zyprexa (Olanzapine) SS 7.5 MG/D Fatigue Keppra Nasal Congestion (Levetiracetam) C Date:10/21/02ISR Number: 3999776-7Report Type:Expedited (15-DaCompany Report #2002060647 Age:48 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Renal Transplant Foreign Nifedipine Rhabdomyolysis Health (Nifedipine) PS ORAL 90 MG Professional (DAILY), ORAL Olanzapine (Olanzapine) SS ORAL 10 MG (DAILY), ORAL Sulfamethoxazole W/Trimethoprim (Bactrim) SS Pethidine C Paroxetine C Lorazepam C Omeprazole C Atenolol C Mycophenolate Mofetil C Sirolimus C Tramadol C Date:10/21/02ISR Number: 3999799-8Report Type:Expedited (15-DaCompany Report #B0282056A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Paxil Tablet Weight Increased Literature (Paroxetine Health Hydrochloride) PS ORAL ORAL Professional Olanzapine (Olanzapine) SS ORAL ORAL Date:10/22/02ISR Number: 3996203-0Report Type:Direct Company Report #CTU 179251 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Zyprexa (Olanzepine) Required Syncope 20mg (Tablet) PS 20MG (1 Intervention to TABLET AT BED Prevent Permanent TIME) Impairment/Damage Date:10/22/02ISR Number: 3996210-8Report Type:Direct Company Report #CTU 179255 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Clozapine PS 100MG /150MG Hospitalization - Pneumonitis Q HS Initial or Prolonged Sinus Tachycardia Olanzapine (Zyprexa) SS 10MG QHS Required Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 2076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/02ISR Number: 3999406-4Report Type:Expedited (15-DaCompany Report #A0383146A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Misuse Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS Date:10/23/02ISR Number: 3999479-9Report Type:Expedited (15-DaCompany Report #B0282395A Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paxil (Formulation Intentional Misuse Health Unknown) (Paroxetine Professional Hydrochloride) PS ORAL ORAL Doxepin (Formulation Unknown) (Doxepin) SS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Date:10/23/02ISR Number: 3999588-4Report Type:Expedited (15-DaCompany Report #A0383134A Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Misuse Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Valproic Acid (Valproic Acid) SS Olanzapine (Olanzapine) SS Date:10/23/02ISR Number: 3999600-2Report Type:Expedited (15-DaCompany Report #A0383142A Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Misuse Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Aspirin (Formulation Unknown) (Aspirin) SS Olanzapine (Formulation Unknown) (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 2077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/02ISR Number: 3999584-7Report Type:Direct Company Report #CTU 179656 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Prozac PS 40 MG 1 DAY @ Psychomotor Hyperactivity BED Syncope Zyprexa SS 5 MG 1 DAY @ BED Date:10/25/02ISR Number: 4001415-6Report Type:Expedited (15-DaCompany Report #2002058781 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fluid Retention Foreign Zoloft (Sertraline) PS ORAL 50 MG Initial or Prolonged Generalised Oedema Health (DAILY), ORAL Inappropriate Professional Olanzapine SS Antidiuretic Hormone Diuretics SS Secretion Quetiapine Fumarate C Weight Decreased Ramipril C Torasemide C Digoxin C Spironolactone C Carvedilol C Date:10/28/02ISR Number: 4000844-4Report Type:Expedited (15-DaCompany Report #USA021022158 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Health Zyprexa PS Completed Suicide Professional Drug Level Increased Intentional Misuse Date:10/28/02ISR Number: 4000845-6Report Type:Expedited (15-DaCompany Report #USA021022160 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS 50 MG/DAY Overdose Professional Company Representative Date:10/28/02ISR Number: 4000846-8Report Type:Expedited (15-DaCompany Report #USA021021998 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Consumer Zyprexa PS 5 MG/DAY Menorrhagia Lithium C Menstruation Irregular Stress Date:10/28/02ISR Number: 4000850-XReport Type:Expedited (15-DaCompany Report #US_021088707 Age:69 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Lung Carcinoma Cell Type Consumer Zyprexa PS Unspecified Stage Iv Depakote (Valproate Mania Semisodium) C Date:10/28/02ISR Number: 4000851-1Report Type:Expedited (15-DaCompany Report #USA021022302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Consumer Zyprexa PS Other Company Representative Date:10/28/02ISR Number: 4000863-8Report Type:Expedited (15-DaCompany Report #USA021022211 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Urine Present Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:10/28/02ISR Number: 4001196-6Report Type:Expedited (15-DaCompany Report #USA021022259 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Pancreatitis Professional (Olanzapine) Renal Failure Acute Company Olanzapine) PS 10 MG/DAY Representative Lopressor (Metoprolol Tartrate) C Zestril (Lisinopril C Zoloft (Sertraline Hydrochloride) C Singulair (Montelukast Sodium C Aspirin C Desyrel (Trazondone Hydrochloride) C Prednisone C Date:10/28/02ISR Number: 4001550-2Report Type:Expedited (15-DaCompany Report #US_020987863 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Zyprexa-Oral Professional (Olanzapine)(Olanzap Company ine) PS Representative 24-Jun-2005 12:19 PM Page: 2079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/02ISR Number: 4001551-4Report Type:Expedited (15-DaCompany Report #USA021022139 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mania Health Prozac-Oral Other Pancreatitis Acute Professional (Fluoxetine)(Fluoxet ine Hydrochloride) PS 40 MG/DAY Zyprexa -Oral (Olanzapine)(Olanzap ine) SS 20 MG/DAY Date:10/28/02ISR Number: 4002339-0Report Type:Expedited (15-DaCompany Report #EWC021032637 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Leukaemia Foreign Zyprexa-Oral Initial or Prolonged Pancytopenia Health (Olanzapine) Professional (Olanzapine) PS Other Imovane (Zopiclone) C Lithium Carbonate C Date:10/28/02ISR Number: 4002341-9Report Type:Expedited (15-DaCompany Report #EWC021032638 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Foreign Olanzapine-Oral Initial or Prolonged Deep Vein Thrombosis Health (Olanzapine) PS 2.5 MG DAY Disability Pseudodiverticular Professional Amaryl (Glimepiride) C Disease Other Stugeron Forte Renal Impairment (Cinnarizine) C Urinary Retention Accupro (Quinapril Urinary Tract Disorder Hydrochloride) C Vesicoureteric Reflux Distraneurin (Clomethiazole Edisilate) C Date:10/28/02ISR Number: 4002342-0Report Type:Expedited (15-DaCompany Report #DE_021009797 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Lower Foreign Zyprexa-Oral Blood Prolactin Increased Health (Olanzapine) Breast Pain Professional (Olanzapine) PS 2.5 MG/1 DAY 2 YR Hypertrophy Breast Other Pituitary Tumour Benign Weight Increased Date:10/28/02ISR Number: 4002343-2Report Type:Expedited (15-DaCompany Report #US_021088669 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Increased Upper Airway Health (Olanzapine) Secretion Professional (Olanzapine) PS 15 MG/DAY Productive Cough Company Representative Other 24-Jun-2005 12:19 PM Page: 2080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/02ISR Number: 4002344-4Report Type:Expedited (15-DaCompany Report #US_021088722 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 100 MG/DAY Company Representative Other Date:10/28/02ISR Number: 4002494-2Report Type:Expedited (15-DaCompany Report #GBS021011651 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Oxazepam C Date:10/28/02ISR Number: 4002506-6Report Type:Expedited (15-DaCompany Report #FR_020901468 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Foreign Zyprexa-Oral Pulmonary Embolism Health (Olanzapine) Pyrexia Professional (Olanzapine) PS 10 MG/DAY Company Effexor (Venlafaxine Representative Hydrochloride) C Other Xanax (Alprazolam) C Date:10/28/02ISR Number: 4002512-1Report Type:Expedited (15-DaCompany Report #FR_020501013 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Aneurysm Foreign Zyprexa-Oral Initial or Prolonged Coronary Artery Disease Health (Olanzapine) Myocardial Infarction Professional (Olanzapine) PS 2.5 MG/DAY Weight Increased Other Imovane (Zopiclone) C Date:10/28/02ISR Number: 4002645-XReport Type:Expedited (15-DaCompany Report #US_020988350 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Diet Refusal Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS 20 MG/DAY Company Representative Date:10/28/02ISR Number: 4002655-2Report Type:Expedited (15-DaCompany Report #US_020987707 Age:30 YR Gender:Male I/FU:F Outcome PT Other Blood Lactate Dehydrogenase Increased Drug Eruption 24-Jun-2005 12:19 PM Page: 2081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eosinophil Count Increased Excoriation Report Source Product Role Manufacturer Route Dose Duration Hepatic Function Abnormal Foreign Olanzapine-Oral Oedema Peripheral Health (Olanzapine) PS 10 MG/DAY Professional Vegetamin A C Company Depas (Etizolam) C Representative Date:10/29/02ISR Number: 4001653-2Report Type:Expedited (15-DaCompany Report #USA021022602 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Consumer Zyprexa-Oral Initial or Prolonged Depressed Level Of (Olanzapine) Consciousness (Olanzapine) PS Diabetes Mellitus Mepiridine Hyperaesthesia Hydrochloride C Tongue Oedema Insulin C Fluid Pill C Blood Pressure Pill C Date:10/29/02ISR Number: 4002023-3Report Type:Expedited (15-DaCompany Report #US_020886730 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Olanzapine-Oral Blood Pressure Decreased Study (Olanzapine) PS 10 MG DAY Depressed Level Of Health Serenace Consciousness Professional (Haloperidol) C Feeling Abnormal Other Contomin Haematemesis (Chlorpromazine Po2 Decreased Hydrochloride) C Shock Haemorrhagic Tegretol Vomiting (Carbamazepine) C Akineton (Biperiden Hydrochloride) C Eurodin (Estazolam) C Rohypnol (Flunitrazepam) C Vegetamin A C Date:10/29/02ISR Number: 4002090-7Report Type:Expedited (15-DaCompany Report #US_020988261 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa-Orla Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) Blood Potassium Decreased Company (Olanzapine) PS 5 MG/DAY Body Temperature Representative Lithium C Increased Cogwheel Rigidity Extrapyramidal Disorder Immobile Loss Of Consciousness White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4002096-8Report Type:Expedited (15-DaCompany Report #USA021022336 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Zyprexa-Oral Other Confusional State Professional (Olanzapine) Diabetic Coma Company (Olanzapine) PS 15 MG/DAY Psychotic Disorder Representative Lithium C Suicidal Ideation Urinary Incontinence Date:10/29/02ISR Number: 4002097-XReport Type:Expedited (15-DaCompany Report #USA021022550 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Zyprexa-Oral Road Traffic Accident Professional (Olanzapine) Company (Olanzapine) PS Representative Date:10/29/02ISR Number: 4002098-1Report Type:Expedited (15-DaCompany Report #USA021022589 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS UNKNOWN Representative Date:10/29/02ISR Number: 4002099-3Report Type:Expedited (15-DaCompany Report #USA021022591 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Zyprexa-Oral Initial or Prolonged Condition Aggravated (Olanzapine) Drug Ineffective (Olanzapine) PS Ejaculation Disorder Lithium C Depakote (Valproate Semisodium) C Date:10/29/02ISR Number: 4002100-7Report Type:Expedited (15-DaCompany Report #USA021022594 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa-Oral Respiratory Depression Professional (Olanzapine) (Olanzapine) PS UNKNOWN Date:10/29/02ISR Number: 4002498-XReport Type:Expedited (15-DaCompany Report #FR_020601092 Age:64 YR Gender:Female I/FU:F Outcome PT Hospitalization - Drug Ineffective Initial or Prolonged Eosinophilia Other Hypersensitivity Interstitial Lung Disease Pyrexia 24-Jun-2005 12:19 PM Page: 2083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restrictive Pulmonary Disease Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Date:10/29/02ISR Number: 4003114-3Report Type:Expedited (15-DaCompany Report #TPA2002A01277 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Actos (Pioglitazone Initial or Prolonged Cataract Hydrochloride) (45 Depression Milligram, Tablets) PS ORAL 45 MG, QAM, Dizziness PER ORAL Fracture Zyprexa Hand Fracture (Olanazpaine) (15 Osteoporosis Milligrams) SS ORAL 15 MG, 1 IN 1 Rib Fracture D, PER ORAL Somnolence Humulin 70/30 Suicidal Ideation (Humulin 70/30) (48 Iu (International Unit), Injection) C Anacin (Anacin) C Clebrex (Celecoxib) C Amigesic (Salsalate) C Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Nitroglycerin (Glyceryl Trinitrate) C Date:10/29/02ISR Number: 4003349-XReport Type:Expedited (15-DaCompany Report #GBS021011722 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa Hospitalization - Congestive Health (Olanzapine) PS 10 MG/2 AT Initial or Prolonged Professional BEDTIME Other Haloperidol C Salmeterol Xinafoate C Diprosone (Betamethasone Dipropionate) C Salamol (Salbutamol Sulfate) C Beclomethasone Dipropionate C Salbutamol C Carbamazepine C Venlafaxine Hydrochloride C 24-Jun-2005 12:19 PM Page: 2084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4003352-XReport Type:Expedited (15-DaCompany Report #GBS021011685 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplasia Pure Red Cell Foreign Olanzapine Initial or Prolonged Health (Olanzapine) PS ORAL 10 MG/DAY Professional Losec (Omeprazole) C Other Levosulpiride C Date:10/29/02ISR Number: 4003355-5Report Type:Expedited (15-DaCompany Report #US_021089023 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine Initial or Prolonged Phosphokinase Increased Literature (Olanzapine) PS ORAL 20 MG/DAY Serotonin Syndrome Health Risperidone C Urinary Incontinence Professional Lithium C White Blood Cell Count Other Citalopram C Increased Date:10/29/02ISR Number: 4003358-0Report Type:Expedited (15-DaCompany Report #US_021088928 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Olanzapine Cyanosis Study (Olanzapine) PS ORAL 10 MG DAY Foreign Body Trauma Health Serenace Injury Asphyxiation Professional (Haloperidol) C Pulse Absent Other Levotomin (Levomepromazine Maleate) C Apamin (Periciazine) C Spiroiptan/Spiperone C Lodopin (Zotepine) C Akineton (Biperiden Hydrochloride) C Marzulene S C Nitrazepam C Insumin (Flurazepam) C Rohypnol (Flunitrazepam) C Levotomin (Levomepromazine Maleate) C Date:10/29/02ISR Number: 4003363-4Report Type:Expedited (15-DaCompany Report #FR_021001558 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Foreign Zyprexa Completed Suicide Health (Olanzapine) PS ORAL 10 MG/DAY Intentional Misuse Professional Haldol Company (Haloperidol) C Representative Other 24-Jun-2005 12:19 PM Page: 2085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4003674-2Report Type:Expedited (15-DaCompany Report #GBS020310307 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Foreign Zyprexa-Oral Initial or Prolonged Brief Psychotic Disorder, Health (Olanzapine) With Postpartum Onset Professional (Olanzapine) PS 10 MG IN THE Caesarean Section Other MORNING; Complications Of Maternal Sertraline C Exposure To Therapeutic Drugs Failed Trial Of Labour Maternal Drugs Affecting Foetus Postpartum Haemorrhage Pregnancy Date:10/29/02ISR Number: 4003683-3Report Type:Expedited (15-DaCompany Report #EWC021032708 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY; A Company FEW YEARS Representative Cisordinol Other (Clopenthixol Hydrochloride) C Date:10/29/02ISR Number: 4003684-5Report Type:Expedited (15-DaCompany Report #EWC021032747 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conjunctivitis Foreign Olanzapine-Oral Mouth Ulceration Health (Olanzapine) PS 10 MG/DAY Stomatitis Haemorrhagic Professional L-Dopa C Company Ascriptin C Representative Alendronate Sodium C Other Ace-Inhibitor C Date:10/29/02ISR Number: 4003686-9Report Type:Expedited (15-DaCompany Report #GBS021011743 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Peroneal Nerve Palsy Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG/1 DAY Professional Venlfaxine C Other Vitamin B12 C Date:10/29/02ISR Number: 4003697-3Report Type:Expedited (15-DaCompany Report #GBS021011610 Age:35 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Diabetic Hyperglycaemic Coma Encephalopathy 24-Jun-2005 12:19 PM Page: 2086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine- Oral Health (Olanzapine) PS 10 MG/DAY Professional Other Date:10/30/02ISR Number: 4002203-7Report Type:Direct Company Report #CTU 180000 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Olanzapine PS Seroquel 25 Mg Tablet SS Date:10/30/02ISR Number: 4002428-0Report Type:Direct Company Report #CTU 180007 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Luvox 150mg Bid P.O. Drug Interaction Prior To 10/19/00 Drug Level Increased -8/22/02 PS ORAL 150 MG PO BID Zyprexa 20mg SS ORAL 20MG BID PO Date:10/30/02ISR Number: 4003441-XReport Type:Expedited (15-DaCompany Report #US_020988238 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Company Hiberna Increased Representative (Promethazine Drug Ineffective Other Hydrochloride) C Jaundice Lexotan (Bromazepam) C Pyrexia Pursennid (Senna Urethral Haemorrhage Leaf) C Urinary Retention Magnesium Oxide C Silece (Flunitrazepam) C Vegetamin A C Date:10/30/02ISR Number: 4003510-4Report Type:Expedited (15-DaCompany Report #US_020584697 Age:30 YR Gender:Male I/FU:F Outcome PT Other Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Triglycerides Increased Cataplexy Electrolyte Imbalance Gamma-Glutamyltransferase 24-Jun-2005 12:19 PM Page: 2087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Hepatic Function Abnormal Hyperglycaemia Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Company Representative Other Date:10/30/02ISR Number: 4003517-7Report Type:Expedited (15-DaCompany Report #US_020887549 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 15 MG DAY Blood Lactate Professional Wypax (Lorazepam) C Dehydrogenase Increased Company Rohypnol Gamma-Glutamyltransferase Representative (Flunitrazepam) C Increased Other Chlorpromazine C Hepatic Function Abnormal Pyrexia Date:10/30/02ISR Number: 4003545-1Report Type:Expedited (15-DaCompany Report #FR_020501013 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Aneurysm Foreign Zyprexa-Oral Initial or Prolonged Coronary Artery Disease Health (Olanzapine) Myocardial Infarction Professional (Olanzapine) PS 2.5 MG DAY Weight Increased Other Imovane (Zopiclone) C Date:10/30/02ISR Number: 4003568-2Report Type:Expedited (15-DaCompany Report #EWC020932494 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Purpura Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Lithium C Citalopram C Date:10/30/02ISR Number: 4003991-6Report Type:Expedited (15-DaCompany Report #USA020820014 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Zyprexa-Oral Other Diabetic Ketoacidosis Professional (Olanzapine) Loss Of Consciousness Company (Olanzapine) PS 15 MG DAY 1 YR Weight Increased Representative Norvasc (Amlodipine Besilate) C Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 2088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/02ISR Number: 4001362-XReport Type:Direct Company Report #CTU 180062 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Zyprexa 5 Mg PS BUCCAL 5 MG DAY Cough BUCCAL Diabetes Mellitus Cipramil C Non-Insulin-Dependent Vioxx C Date:10/31/02ISR Number: 4002126-3Report Type:Direct Company Report #CTU 180041 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Olanzapine 20mg Hospitalization - Confusional State Eli Lilly PS Eli Lilly ORAL 20MG TWICE Initial or Prolonged Diabetic Ketoacidosis DAILY ORAL Required Thorazine C Intervention to Lorazepam C Prevent Permanent Impairment/Damage Date:10/31/02ISR Number: 4003060-5Report Type:Direct Company Report #CTU 180101 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Zyprexa 2.5mg 5mg Required Difficulty In Walking & 10 Mg Lilly PS Lilly TAPERED DOSES Intervention to Somnolence Ec Aspirin C Prevent Permanent Levothyroxin C Impairment/Damage Multivitamins C Oscal W/ D C Pericolace C Pbn Oint C Prevacid C Tylenol C Lithium C Date:10/31/02ISR Number: 4003079-4Report Type:Direct Company Report #CTU 180098 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Zyprexa 5mg Lilly PS Lilly TAPERED UP Other AND DOWN Zyprexa 2.5mg Lilly SS Lilly Mom C Vasotec C Vioxx C Cogentin C Oscal C Valproic Acid C Date:10/31/02ISR Number: 4003105-2Report Type:Direct Company Report #CTU 180099 Age:62 YR Gender:Female I/FU:I Outcome Other Required Intervention to 24-Jun-2005 12:19 PM Page: 2089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Zyprexa 2.5 Mg Lilly Difficulty In Walking 5 Mg&10 Mg PS TAPERED DOSES Somnolence El Aspirin C Levohydroxin C Multivitamins C Oscal With D C Pericolace C Pbn Oint C Prevacid C Tylenol C Lithium C Date:10/31/02ISR Number: 4003907-2Report Type:Expedited (15-DaCompany Report #USA020616537 Age:2 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Blood Pressure Decreased Health (Olanzapine) Electrocardiogram Pr Professional (Olanzapine) PS 25 MG Shortened Erythromycin Heart Rate Decreased W/Sulfisoxazole C Overdose Somnolence Tachycardia Date:10/31/02ISR Number: 4003972-2Report Type:Expedited (15-DaCompany Report #USA020820553 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Darvocet-.(Propoxyph Initial or Prolonged Abnormal Professional ene Hydrochloride) PS Other Malnutrition Company Zyprexa-Oral Underweight Representative (Olanzapine) (Olanzapine) SS Advair C Trazodone C Paxil (Paroxetine Hydrochloride) C Dyazide C Prevacid (Lansoprazole) C Aciphex (Rabeprazole Sodium) C Date:10/31/02ISR Number: 4003973-4Report Type:Expedited (15-DaCompany Report #USA020920701 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Test Abnormal Health Zyprexa-Oral Myocardial Infarction Professional (Olanzapine) Company (Olanzapine) PS 20 MG/AT Representative BEDTIME Lisinopril C Hydrochlorothiazide C 24-Jun-2005 12:19 PM Page: 2090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/02ISR Number: 4003984-9Report Type:Expedited (15-DaCompany Report #US_020887506 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Consumer Zyprexa Oral Initial or Prolonged Palpitations Health (Olanzapine)(Olanzap Renal Failure Acute Professional ine) PS Rhabdomyolysis Neurontin(Gabapentin ) C Trazadone C Dilaudid(Hydromorpho ne Hydrochloride) C Nicotine Dermal Patch(Nicotine Resin) C Date:10/31/02ISR Number: 4004407-6Report Type:Expedited (15-DaCompany Report #2002UW14400 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Purpura Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Thrombocytopenia Health PO 9 DAY Prevent Permanent Professional Zyprexa SS 2.5 MG DAILY 19 MON Impairment/Damage Other Asa C Centrum Forte C Cimetidine C Lorazepam C Vitamin B Complex C Vitamin E C Zopiclone C Date:10/31/02ISR Number: 4004929-8Report Type:Expedited (15-DaCompany Report #2002AP03573 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Intentional Misuse Health Olanzapine SS Toxicologic Test Abnormal Professional Date:10/31/02ISR Number: 4005036-0Report Type:Expedited (15-DaCompany Report #FLUV00302002674 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Floxyfral 100 Initial or Prolonged Oedema Peripheral Other (Fluovoxamine Disability Weight Increased Maleate) PS ORAL 150 MG DAILY PO Zyprexa (Olanzapine) SS ORAL 15 MG DAILY PO Tranxilium (Clorazepate Dipotassium) C 24-Jun-2005 12:19 PM Page: 2091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/02ISR Number: 4005098-0Report Type:Expedited (15-DaCompany Report #2002063342 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Zoloft (Sertraline) PS ORAL 200 MG Hospitalization - Neutropenia Health (DAILY), ORAL Initial or Prolonged Professional Olanzapine SS ORAL 10 MG Other (DAILY), ORAL Isopromethazine Hydrochloride SS ORAL 60 MG (DAILY) ORAL Lorazepam C Zopiclone C .. C Date:11/05/02ISR Number: 4003903-5Report Type:Direct Company Report #CTU 180342 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Weight Increased Olanzipine 7.5 Mg Va Disability Medical Center PS ORAL 1 TAB NIGHTLY Required ORAL Intervention to Prevent Permanent Impairment/Damage Date:11/05/02ISR Number: 4006688-1Report Type:Expedited (15-DaCompany Report #PHEH2002US09332 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Salivary Hypersecretion Professional Tablet PS ORAL 300 MG, BID, ORAL Zyprexa (Olanzapine) SS Lithium (Lithium) C Artane (Trihexyphenidyl Hydrochloride) C Glucotrol Xl (Glipizide) C Actos / Usa / (Pioglitazone Hydrochloride, Pioglitazone) C Date:11/05/02ISR Number: 4006710-2Report Type:Expedited (15-DaCompany Report #HQ4985931OCT2002 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Diphenhydramine Hcl Intentional Misuse (Diphenhydramine Hydrochloride, Injection) PS OVERDOSE Fluoxetine (Fluoxetine) SS OVERDOSE Olanzapine (Olanzapine) SS OVERDOSE 24-Jun-2005 12:19 PM Page: 2092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/02ISR Number: 4006726-6Report Type:Expedited (15-DaCompany Report #HQ4987831OCT2002 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Literature Fentanyl Citrate (Fentanyl Citrate, Injection) PS FATAL OVERDOSE, AMOUNT UNKNOWN Olanzapine (Olanzapine) SS Zolpidem (Zolpidem) SS Date:11/06/02ISR Number: 4007620-7Report Type:Expedited (15-DaCompany Report #USA021022139 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mania Health Prozac-Oral Other Pancreatitis Acute Professional (Fluoxetine) (Fluoxetine Hydrochloride) PS 80 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG/DAY Axid (Nizatidine) SS Date:11/06/02ISR Number: 4007678-5Report Type:Expedited (15-DaCompany Report #US_020988011 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa-Oral Hospitalization - Congestive Professional (Olanzapine) Initial or Prolonged Catheter Related (Olanzapine) PS 800 MG Other Complication Lithium C Choreoathetosis Clonic Convulsion Coma Completed Suicide Confusional State Drug Level Increased Dysarthria Grimacing Haemorrhage Subcutaneous Hypotonia Hypoxia Injection Site Haemorrhage Intentional Misuse Nuclear Magnetic Resonance Imaging Brain Abnormal Nystagmus Pathogen Resistance Pneumonia Somnolence Status Epilepticus 24-Jun-2005 12:19 PM Page: 2093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/02ISR Number: 4007680-3Report Type:Expedited (15-DaCompany Report #USA020921779 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Professional (Olanzapine) Other Syndrome (Olanzapine) PS 20 MG/DAY 3 YR Pneumonia Depakote (Valproate Semisodium) C Wellbutrin (Amfebutamone Hydrochloride) C Date:11/06/02ISR Number: 4007705-5Report Type:Expedited (15-DaCompany Report #USA021022798 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/06/02ISR Number: 4007852-8Report Type:Expedited (15-DaCompany Report #USA020719107 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Health Zyprexa-Oral Hospitalization - Loss Of Consciousness Professional (Olanzapine) Initial or Prolonged Pancreatitis (Olanzapine) PS 15 MG DAY Other Depakote (Valproate Semisodium) C Date:11/06/02ISR Number: 4007855-3Report Type:Expedited (15-DaCompany Report #USA021022690 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa-Oral Initial or Prolonged Anxiety Professional (Olanzapine) Other Neoplasm Company (Olanzapine) PS 40 MG/DAY Tardive Dyskinesia Representative Lithium C Tic Date:11/06/02ISR Number: 4008622-7Report Type:Expedited (15-DaCompany Report #EWC021032825 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Quadriparesis Foreign Olanzapine-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) PS 5 MG/DAY Professional Fluoxamine C Other Date:11/06/02ISR Number: 4008624-0Report Type:Expedited (15-DaCompany Report #EWC021032788 Age:33 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Electrocardiogram 24-Jun-2005 12:19 PM Page: 2094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Electrocardiogram T Wave Inversion Overdose Report Source Product Role Manufacturer Route Dose Duration Somnolence Foreign Olanzapine-Oral Tachycardia Health (Olanzapine) PS Professional Other Date:11/06/02ISR Number: 4008625-2Report Type:Expedited (15-DaCompany Report #DE_021009896 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Foreign Zyprexa-Oral Initial or Prolonged Diarrhoea Haemorrhagic Health (Olanzapine) Henoch-Schonlein Purpura Professional (Olanzapine) PS ORAL Leukocytoclastic Other Phenytoin C Vasculitis Prohipendyl C Date:11/06/02ISR Number: 4008626-4Report Type:Expedited (15-DaCompany Report #DE_021009878 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa - Oral Initial or Prolonged Aminotransferase Health (Olanzapine) Increased Professional (Olanzapine) PS 15 MG/DAY Rhabdomyolysis Company Remergil Representative (Mirtazapine) C Other Date:11/06/02ISR Number: 4008628-8Report Type:Expedited (15-DaCompany Report #US_021089160 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Olanzapine-Oral Phosphokinase Increased Study (Olanzapine) PS Hepatocellular Damage Health Risperdal Hypercholesterolaemia Professional (Risperidone) C Restless Legs Syndrome Other Akineton (Biperiden Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Date:11/06/02ISR Number: 4008630-6Report Type:Expedited (15-DaCompany Report #EWC021032824 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Olanzapine-Oral Parkinsonism Health (Olanzapine) PS 10 MG/DAY 18 MON Professional Epilim (Valproate Company Sodium) C Representative Other 24-Jun-2005 12:19 PM Page: 2095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/02ISR Number: 4008632-XReport Type:Expedited (15-DaCompany Report #CA_021005447 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Foreign Olanzapine-Oral Arrhythmia Health (Olanzapine) PS 25 MG/DAY Blood Alcohol Increased Professional Pulmonary Oedema Company Representative Other Date:11/06/02ISR Number: 4008635-5Report Type:Expedited (15-DaCompany Report #DE_021009810 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Dispersible Initial or Prolonged Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 20 MG/IN THE Myocarditis Company EVENING Representative Other Date:11/06/02ISR Number: 4008636-7Report Type:Expedited (15-DaCompany Report #US_021089150 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Olanzapine-Oral Initial or Prolonged Diarrhoea Study (Olanzapine) PS 20 MG DAY Excitability Health Panaldine( Gastrointestinal Professional Ticlopidine Haemorrhage Other Hyrochloride) C Ileus Paralytic Magnesium Oxide C Insomnia Tinelac (Sennoside Transient Ischaemic A+B) C Attack Hirnamin (Levomepromazine) C Pyrethia (Promethazine Hydrochloride) C Vegetamin B C Date:11/06/02ISR Number: 4008642-2Report Type:Expedited (15-DaCompany Report #GBS021011773 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Olanzapine-Oral Other Infarction Consumer (Olanzapine) PS 7.5 MG/DAY Apnoea Other Epilim (Valproate Bite Sodium) C Cardiac Arrest Tegretol Dyspnoea Exacerbated (Carbamazepine) C Grand Mal Convulsion Diazepam C Myocardial Ischaemia Lamictal Tongue Disorder (Lamotrigine) C Aspirin C Pulmicort (Budesonide) C Combivent C 24-Jun-2005 12:19 PM Page: 2096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/02ISR Number: 4008649-5Report Type:Expedited (15-DaCompany Report #EWC021032567 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Test Abnormal Foreign Olanzapine-Oral Initial or Prolonged Differential White Blood Health (Olanzapine) PS 10 MG/DAY Other Cell Count Abnormal Professional Headache Other Neutrophil Count Increased Viral Infection White Blood Cell Count Increased Date:11/06/02ISR Number: 4008651-3Report Type:Expedited (15-DaCompany Report #US_021088928 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Olanzapine-Oral Injury Asphyxiation Study (Olanzapine) PS 10 MG DAY Pulse Absent Health Serenace Pulse Pressure Decreased Professional (Haloperidol) C Other Levotomin (Levomepromazine Maleate) C Apamin (Periciazine) C Spiroiptan/Spiperone C Lodopin (Zotepine) C Akineton (Biperiden Hydrochloride) C Marzulene S C Nitrazepam C Insumin (Flurazepam) C Rohypnol (Flunitrazepam) C Levotomin (Levomepromazine Maleate) C Date:11/06/02ISR Number: 4008652-5Report Type:Expedited (15-DaCompany Report #US_020887313 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Olanzapine-Oral Other Blood Sodium Increased Study (Olanzapine) PS 20 MG/DAY Convulsion Health Risperdal Depressed Level Of Professional (Risperidone) C Consciousness Company Tasmolin (Biperiden) C Diarrhoea Representative Ubretid (Distigmine Hyponatraemia Other Bromide) C Malnutrition Silece Nausea (Flunitrazepam) C Neuroleptic Malignant Contomin Syndrome (Chlorpromazine Polydipsia Hydrochloride) C Rhabdomyolysis Depromel Tachycardia (Fluvoxamine) C Urinary Incontinence Hypen (Etodolac) C Water Intoxication Zyloric (Allopurinol) C 24-Jun-2005 12:19 PM Page: 2097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Methycobal (Mecobalamin) C Date:11/06/02ISR Number: 4008657-4Report Type:Expedited (15-DaCompany Report #FR_020601092 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Foreign Zyprexa-Oral Initial or Prolonged Interstitial Lung Disease Health (Olanzapine) Restrictive Pulmonary Professional (Olanzapine) PS 7.5 MG/DAY Disease Other Date:11/06/02ISR Number: 4008818-4Report Type:Expedited (15-DaCompany Report #EWC021032791 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Olanzapine-Oral Initial or Prolonged Agitation Health (Olanzapine) PS 10 MG Drug Toxicity Professional Irritability Other Somnolence Date:11/06/02ISR Number: 4008819-6Report Type:Expedited (15-DaCompany Report #US_021089053 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Prozac-Oral Initial or Prolonged Health (Fluoxetine) Professional (Fluoxetine Company Hydrochloride) PS 20 MG/DAY Representative Zyprexa-Oral Other (Olanzapine) (Olanzapine) SS 10 MG/DAY Date:11/07/02ISR Number: 4008655-0Report Type:Expedited (15-DaCompany Report #EWC010526709 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa (Olanzapine) PS 10 MG/DAY 1 MON Initial or Prolonged Exposure To Therapeutic Health Cisordinol Drugs Professional (Clopenthixol Psychotic Disorder Company Hydrochloride) C Representative Disipal Other (Orphenadrine Hydrochloride) C Date:11/07/02ISR Number: 4009112-8Report Type:Expedited (15-DaCompany Report #HQ5008401NOV2002 Age:37 YR Gender:Male I/FU:I Outcome PT Hospitalization - Electrocardiogram Qt Initial or Prolonged Prolonged Other Hypotension Intentional Misuse Oliguria Pneumonia Aspiration 24-Jun-2005 12:19 PM Page: 2098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Report Source Product Role Manufacturer Route Dose Duration Literature Efexor (Venlafaxine Hydrochloride, Unspec) PS ORAL 9450MG (OVERDOSE AMAOUNT) Olanzapine (Olanzapine,) SS ORAL 700 MG (OVERDOSE AMOUNT) Date:11/07/02ISR Number: 4009319-XReport Type:Expedited (15-DaCompany Report #GB9334504NOV2002 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Peroneal Nerve Palsy Foreign Efexor (Venlafaxine Other Health Hydrochloride, Professional Tablet, 0) PS ORAL SEE IMAGE 57 DAY Other Zyprexa (Olanzapine, ,0) SS ORAL 5 MG 1X PER 1 DAY ORAL 94 DAY Vitamin B12 (Cyanocobalamin And Derivatives) (Vitamin B12 (Cyanocobalamin And C Date:11/10/02ISR Number: 4014565-5Report Type:Expedited (15-DaCompany Report #GBS021111874 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Withdrawal Syndrome Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Other Date:11/12/02ISR Number: 4009848-9Report Type:Expedited (15-DaCompany Report #US_020988350 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Zyprexa-Oral Initial or Prolonged Diet Refusal Health (Olanzapine) Fatigue Professional (Olanzapine) PS 20 MG/DAY Hyperglycaemia Company Representative Other Date:11/12/02ISR Number: 4009851-9Report Type:Expedited (15-DaCompany Report #US_020987637 Age:29 YR Gender:Female I/FU:F Outcome PT Hospitalization - Antisocial Behaviour Initial or Prolonged Anxiety Depressed Level Of Consciousness 24-Jun-2005 12:19 PM Page: 2099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Drug Toxicity Overdose Report Source Product Role Manufacturer Route Dose Duration Stress Foreign Zyprexa-Oral Suicidal Ideation Health (Olanzapine) Suicide Attempt Professional (Olanzapine) PS 14 DSG Company FORM/DAY Representative Depas (Etizolam) C Other Pursennid (Senna Leaf) C Date:11/12/02ISR Number: 4009856-8Report Type:Expedited (15-DaCompany Report #USA021022917 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Consumer Zyprexa-Oral Initial or Prolonged Oedema (Olanzapine) Oedema Peripheral (Olanzapine) PS 10 MG/DAY 4 WK Somnolence Tachycardia Weight Increased Date:11/12/02ISR Number: 4009891-XReport Type:Expedited (15-DaCompany Report #US_020484031 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Zyprexa-Oral Complications Of Maternal Professional (Olanzapine) Exposure To Therapeutic Company (Olanzapine) PS 7.5 MG/2 DAY Drugs Representative Prozac-Oral Polyhydramnios (Fluoxetine) Weight Increased (Fluoxetine Hydrochloride) SS 50 MG/DAY Klonopin (Clonazepam) C Geodon (Ziprasidone Hydrochloride) C Date:11/12/02ISR Number: 4010285-1Report Type:Expedited (15-DaCompany Report #GBS021111842 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Lorazepam C Date:11/12/02ISR Number: 4010289-9Report Type:Expedited (15-DaCompany Report #US_021089358 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Condition Aggravated Health (Olanzapine) Hallucination, Auditory Professional (Olanzapine) PS 10 MG/DAY Company Eurodin (Estazolam) C Representative Other 24-Jun-2005 12:19 PM Page: 2100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/02ISR Number: 4010297-8Report Type:Expedited (15-DaCompany Report #US_021189448 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Olanzapine-Oral Initial or Prolonged Gastric Mucosal Lesion Study (Olanzapine) PS 20 MG DAY Haematemesis Health Wintermin Hepatic Function Abnormal Professional (Chlorpromazine White Blood Cell Count Other Hydrochloride) C Increased Linton (Haloperidol) C Tasmolin (Biperiden) C Pantosin (Pantethine) C Hirnamin (Levomepromazine) C Lendormin (Brotizolam) C Halcion (Triazolam) C Magnesium Oxide C Pursennid (Senna Leaf) C Sodium Picosulfate C Lexin (Carbamazepine) C Date:11/12/02ISR Number: 4010304-2Report Type:Expedited (15-DaCompany Report #EWC021032835 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Zyprexa-Oral Hospitalization - Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 10 MG/DAY Other Efexor (Venlafaxine Hydrochloride) C Temazepam C Date:11/12/02ISR Number: 4010696-4Report Type:Expedited (15-DaCompany Report #US_021189528 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Zyprexa-Oral Consciousness Health (Olanzapine) Fear Professional (Olanzapine) PS ORAL 10 MG/DAY Hepatic Function Abnormal Company Hypothermia Representative Somnolence Other Date:11/12/02ISR Number: 4010702-7Report Type:Expedited (15-DaCompany Report #APCDSS2002001317 Age:84 YR Gender:Male I/FU:I Outcome PT Life-Threatening C-Reactive Protein Required Increased Intervention to Dehydration Prevent Permanent Depressed Level Of Impairment/Damage Consciousness Hypertonia Lower Respiratory Tract Infection 24-Jun-2005 12:19 PM Page: 2101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Red Blood Cell Sedimentation Rate Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Reminyl (Tablet) Serotonin Syndrome Health (Galantamine) PS ORAL 4 MG, 2 IN 1 Somnolence Professional DAY(S), ORAL Avanza (Mirtazapine) SS SEE TEXT Zyprexa (Olanzapine) SS SEE TEXT Digoxin Pg (Digoxin) C Warfarin (Warfarin) C Lasix (Furosemide) C Date:11/12/02ISR Number: 4010876-8Report Type:Expedited (15-DaCompany Report #FR_021001558 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Intentional Misuse Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Haldol(Haloperidol) C Representative Bromazepam C Other Date:11/12/02ISR Number: 4010877-XReport Type:Expedited (15-DaCompany Report #DE_020909646 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa-Oral Hospitalization - Difficulty In Walking Health (Olanzapine) Initial or Prolonged Dyspnoea Professional (Olanzapine) PS 20 MG/DAY Hyponatraemia Other Inappropriate Antidiuretic Hormone Secretion Date:11/12/02ISR Number: 4011467-5Report Type:Expedited (15-DaCompany Report #US_021088722 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Aspartate Professional (Olanzapine) PS 100 MG/DAY Aminotransferase Company Increased Representative Depressed Level Of Other Consciousness Formication Intentional Misuse Rhabdomyolysis Somnolence Stress Suicide Attempt 24-Jun-2005 12:19 PM Page: 2102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/02ISR Number: 4011551-6Report Type:Expedited (15-DaCompany Report #USA021022302 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Consumer Zyprexa-Oral Hospitalization - Confusional State Health (Olanzapine) Initial or Prolonged Diabetic Coma Professional (Olanzapine) PS 15 MG/DAY Other Glycosylated Haemoglobin Company Lithium C Increased Representative Effexor-Xr Incontinence (Venlafaxine Renal Failure Acute Hydrochloride) C Date:11/12/02ISR Number: 4011697-2Report Type:Expedited (15-DaCompany Report #USA021023160 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG/EVERY 4 Representative HOUR Ativan (Lorazepam) C Haldol (Haloperidol) C Date:11/12/02ISR Number: 4011702-3Report Type:Expedited (15-DaCompany Report #USA021022972 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/12/02ISR Number: 4011704-7Report Type:Expedited (15-DaCompany Report #USA021022950 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 225 MG/DAY Flexeril (Cyclobenzaprine Hydrochloride) C Xanax (Alprazolam) C Effexor (Venlafaxine Hydrochloride) C Date:11/12/02ISR Number: 4011707-2Report Type:Expedited (15-DaCompany Report #US_021089349 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Zyprexa-Oral Foetal Heart Rate Professional (Olanzapine) Decreased Company (Olanzapine) PS Maternal Drugs Affecting Representative Prozac-Oral Foetus (Fluoxetine) Polyhydramnios (Fluoxetine Premature Baby Hydrochloride) SS Prescribed Overdose Klonopin 24-Jun-2005 12:19 PM Page: 2103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Geodon (Ziprasidone Hydrochloride) C Date:11/13/02ISR Number: 4011817-XReport Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Seroquel PS ORAL 2002 MG TID Initial or Prolonged Infarction Health PO Required Cardiomyopathy Professional Olanzapine SS Intervention to Delirium Other Cipramil C Prevent Permanent Depressed Level Of Haloperidol C Impairment/Damage Consciousness Temazepam C Electrocardiogram T Wave Abnormal Psychotic Disorder Ventricular Hypokinesia Date:11/13/02ISR Number: 4023668-0Report Type:Periodic Company Report #USA020210909 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 40 MG/DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/DAY Date:11/13/02ISR Number: 4023680-1Report Type:Periodic Company Report #USA020210901 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS 15 MG/DAY Initial or Prolonged Prescribed Overdose Professional Prozac Weekly-Weekly Tardive Dyskinesia Company (Once A Week Representative Formulation) (Flu SS 180 MG/WEEK Date:11/13/02ISR Number: 4028960-1Report Type:Periodic Company Report #US_990420639 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa-Oral Initial or Prolonged Blood Triglycerides (Olanzapine) PS ORAL 20 MG/1 DAY Other Increased Prozac-Oral Convulsion (Fluoxetine) Hallucination, Auditory (Fluoxetine Hydrochloride) SS ORAL 40 MG/1 DAY 3 YR Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Pepcid (Famotidine) C Topamax (Topiramate) C 24-Jun-2005 12:19 PM Page: 2104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4028968-6Report Type:Periodic Company Report #USA020819283 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) PS ORAL 10 MG/DAY Somnolence Company Prozac-Oral Representative (Fluoxetine) (Fluoxetine Hydrochloride) C ORAL Buspar (Buspirone Hydrochloride) C Date:11/13/02ISR Number: 4028971-6Report Type:Periodic Company Report #USA020718326 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) (Olanzapine) PS ORAL 10 MG/DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 50 MG/DAY Ms Contin (Morphine Sulfate) C Msir (Morphine Sulfate) C Norvasc (Amlodipine Besilate) C Monopril (Fosinopril Sodium) C Prevacid (Lansoprazole) C Azulfidine (Sulfasalazine) C Folic Acid C Thiamine C Flexeril (Cyclobenzaprine Hydrochloride) C Date:11/13/02ISR Number: 4028972-8Report Type:Periodic Company Report #USA020718045 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Zyprexa-Oral Other Joint Stiffness Professional (Olanzapine) Pyrexia Company (Olanzapine) PS ORAL 10 MG/DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS ORAL 20 MG/DAY Trazadone (Trazodone) C Vicodin C Concerta (Methyphenidate Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4028973-XReport Type:Periodic Company Report #USA020718078 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Prozac-Oral Initial or Prolonged Professional (Fluoxetine) PS ORAL 40 MG/DAY Company Zyprexa-Oral Representative (Olanzapine) (Olanzapine) SS ORAL 30 MG/DAY Valproic Acid C Clozaril (Clozapine) C Date:11/13/02ISR Number: 4028979-0Report Type:Periodic Company Report #USA020414849 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Zyprexa-Oral Initial or Prolonged Anger (Olanzapine) Hostility (Olanzapine) PS ORAL 20 MG/DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS ORAL Tegretol (Carbamazepine) C Date:11/13/02ISR Number: 4028986-8Report Type:Periodic Company Report #USA020312773 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa Initial or Prolonged (Olanzapine) PS 10 MG/2 DAY Prozac (Fluoxetine Hydrochloride) SS ORAL 20 MG/DAY Artane (Trihexyphenidyl Hydorchloride) C Risperdal (Risperidone) C Date:11/14/02ISR Number: 4012887-5Report Type:Expedited (15-DaCompany Report #2002133055US Age:43 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Dramamine Health (Dimenhydrinate) Professional Tablet PS ORAL ORAL Fluoxetine (Fluoxetine) SS Olanzapine (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 2106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/02ISR Number: 4011295-0Report Type:Direct Company Report #CTU 181054 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Zyprexa 5 Mg PS 5MG QAM/PM,.5MG QHS, 5MG QAM/PM 2.5MG QHS Adderall Xr 70mg Qam SS 70MG QAM Celexa 20mg Qd SS 20MG QD Tenex 1mg Tid C 1MG TID Date:11/15/02ISR Number: 4011364-5Report Type:Direct Company Report #CTU 181019 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS ORAL 50MG HS ORAL Initial or Prolonged Delirium Olanzepine SS ORAL 10MG BID ORAL Dry Mouth Apap C Haemodynamic Instability Divalproex C Mental Status Changes Gabapentin C Mydriasis Haldol C Pneumonia Lorazepam C Pyrexia Chlorpromazine C Tachycardia Benztropine C Date:11/15/02ISR Number: 4013420-4Report Type:Expedited (15-DaCompany Report #2002133078US Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Xanax (Alprazolam) Health Tablet PS Professional Desipramine (Desipramine) SS Olanzapin E(Olanzapine) SS Date:11/18/02ISR Number: 4014887-8Report Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Infarction Health Olanzapine SS Required Cardiomyopathy Professional Cipramil C Intervention to Delirium Other Haloperidol C Prevent Permanent Depressed Level Of Temazepam C Impairment/Damage Consciousness Electrocardiogram T Wave Abnormal Ventricular Hypokinesia Date:11/18/02ISR Number: 4157179-9Report Type:Periodic Company Report #2002-07-1382 Age:37 YR Gender:Male I/FU:F Outcome PT Other Agitation Disorientation 24-Jun-2005 12:19 PM Page: 2107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Insomnia Mania Report Source Product Role Manufacturer Route Dose Duration Health Peg-Intron Professional (Peginterferon Company Alfa-2b) Injectable Representative Powder PS SUBCUTANEOUS 150 UG QWK SUBCUTANEOUS Rebetol (Ribavirin) Capsules SS ORAL 800 MG QD ORAL Zyprexa (Olanzapine) SS 5-10 MG QD 3 DAY Paxil C 40 MG QD Serax C 30 MG HS Claritin (Loratadine) C 1 QD Date:11/19/02ISR Number: 4012834-6Report Type:Direct Company Report #CTU 181340 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Generalised Zyprexa 7.5mg PS ORAL 7.5MG PO HS Rash Maculo-Papular Date:11/19/02ISR Number: 4014511-4Report Type:Expedited (15-DaCompany Report #US_021189666 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Other Drug Level Increased Health (Olanzapine) PS Professional Carbamazepine C Clonidine C Date:11/19/02ISR Number: 4014513-8Report Type:Expedited (15-DaCompany Report #US_021189717 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Oxcarbazepine C Charcoal C Date:11/19/02ISR Number: 4014517-5Report Type:Expedited (15-DaCompany Report #US_021189732 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Date:11/19/02ISR Number: 4014539-4Report Type:Expedited (15-DaCompany Report #US_021189590 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Akathisia Foreign Initial or Prolonged Mania Study 24-Jun-2005 12:19 PM Page: 2108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS 10 MG DAY Contomin (Chlorpromazine Hydrochloride) C Impromen (Bromperidol) C Artane (Trihehyphenidyl Hydrochloride) C Depas (Etizolam) C Silece (Flunitrazepam) C Pyrethia (Promethazine Hydrochloride) C Limas (Lithium Carbonate) C Date:11/19/02ISR Number: 4014542-4Report Type:Expedited (15-DaCompany Report #US_021189656 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Seroquel C Representative Tegretol Other (Carbamazepine) C Chlorpromazine C Date:11/19/02ISR Number: 4014546-1Report Type:Expedited (15-DaCompany Report #US_021189701 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Other Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Ethanol C Date:11/19/02ISR Number: 4014548-5Report Type:Expedited (15-DaCompany Report #US_021189736 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Date:11/19/02ISR Number: 4014562-XReport Type:Expedited (15-DaCompany Report #US_021189685 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Desipramine C 24-Jun-2005 12:19 PM Page: 2109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alprazolam C Date:11/19/02ISR Number: 4014566-7Report Type:Expedited (15-DaCompany Report #US_021189687 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Paroxetine C Trazodone C Date:11/19/02ISR Number: 4014567-9Report Type:Expedited (15-DaCompany Report #FR_021101632 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Zyprexa-Oral Initial or Prolonged Cytolytic Hepatitis Health (Olanzapine) Escherichia Sepsis Professional (Olanzapine) PS 5 MG/DAY Escherichia Urinary Tract Other Tercian Infection (Cyamemazine) C Pyelonephritis Acute Deroxat (Paroxetine Tremor Hydrochloride) C ... C ... C ... C ... C ... C ... C ... C ... C Date:11/19/02ISR Number: 4014569-2Report Type:Expedited (15-DaCompany Report #EWC021133007 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epistaxis Foreign Olanzapine-Oral Mouth Haemorrhage Health (Olanzapine) PS 10 MG/DAY Professional Clonazepam C Company Clozapine C Representative Topiramate C Other Propranolol C Date:11/19/02ISR Number: 4014570-9Report Type:Expedited (15-DaCompany Report #US_021189623 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Other Drug Toxicity Health (Olanzapine) PS Professional Aspirin C Bupropion C 24-Jun-2005 12:19 PM Page: 2110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/02ISR Number: 4014581-3Report Type:Expedited (15-DaCompany Report #US_021189719 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Olanzapine-Oral Other Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Quetiapine C Respiratory Arrest Date:11/19/02ISR Number: 4014587-4Report Type:Expedited (15-DaCompany Report #US_021189722 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Trazodone C Respiratory Arrest Furosemide C Date:11/19/02ISR Number: 4014591-6Report Type:Expedited (15-DaCompany Report #US_021189699 Age:76 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Literature Olanzapine-Oral Other Health (Olanzapine) PS Professional Tranylcypromine C Lamotrigine C Date:11/19/02ISR Number: 4014602-8Report Type:Expedited (15-DaCompany Report #US_021189725 Age:48 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Level Above Health (Olanzapine) PS Therapeutic Professional Clorazepate C Drug Toxicity Modafinil C Date:11/19/02ISR Number: 4014609-0Report Type:Expedited (15-DaCompany Report #US_021189644 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Other Drug Toxicity Health (Olanzapine) PS Professional Doxepin C Paroxetine C Date:11/19/02ISR Number: 4014612-0Report Type:Expedited (15-DaCompany Report #US_021189680 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Bupropion C Valproic Acid C 24-Jun-2005 12:19 PM Page: 2111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/02ISR Number: 4014617-XReport Type:Expedited (15-DaCompany Report #US_021189676 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Amitriptyline C Clonazepam C Date:11/19/02ISR Number: 4014618-1Report Type:Expedited (15-DaCompany Report #US_021189632 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Literature Olanzapine-Oral Health (Olanzapine) PS Professional Fentanyl C Zolpidem C Date:11/19/02ISR Number: 4015141-0Report Type:Expedited (15-DaCompany Report #2002066177 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Geodon (Ziprasidone) PS 160 MG Chest Pain Professional Olanzapine SS 20 MG Electrocardiogram Qt Company Corrected Interval Representative Prolonged Date:11/19/02ISR Number: 4015145-8Report Type:Expedited (15-DaCompany Report #USA021123457 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Zyprexa-Oral Thrombocythaemia Professional (Olanzapine) (Olanzapine) PS Interferon C Ribavirin C Date:11/19/02ISR Number: 4015147-1Report Type:Expedited (15-DaCompany Report #USA021123453 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa-Oral Other Sudden Death Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/19/02ISR Number: 4015149-5Report Type:Expedited (15-DaCompany Report #USA021123338 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa-Oral Hospitalization - Congestive Professional (Olanzapine) Initial or Prolonged Fatigue Company (Olanzapine) PS 20 MG/DAY Representative Xanax (Alprazolam) C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/02ISR Number: 4015150-1Report Type:Expedited (15-DaCompany Report #USA021023270 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Delusion Professional (Olanzapine) Psychotic Disorder Company (Olanzapine) PS 5 MG/DAY 1 MON Representative Effexor (Venlafaxine Hydrochloride) C Neurontin (Gabapentin) C Date:11/19/02ISR Number: 4015208-7Report Type:Expedited (15-DaCompany Report #US_021189673 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Other Drug Level Increased Health (Olanzapine) PS Professional Valproic Acid C Date:11/19/02ISR Number: 4015211-7Report Type:Expedited (15-DaCompany Report #US_021189698 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Health (Olanzapine) PS Professional Bupropion C Date:11/19/02ISR Number: 4015214-2Report Type:Expedited (15-DaCompany Report #US_021189700 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Ethanol C Date:11/19/02ISR Number: 4015218-XReport Type:Expedited (15-DaCompany Report #US_021189709 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Fluoxetine-Oral (Fluoxetine) (Fluoxetine Hydrochlor SS Diphenhydramine C Date:11/19/02ISR Number: 4015405-0Report Type:Expedited (15-DaCompany Report #US_021189677 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Nortriptyline Exposure To Toxic Agent Health (Nortriptyline Professional Hydrochloride) PS Olanzapine-Oral (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 2113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram C Date:11/19/02ISR Number: 4015484-0Report Type:Expedited (15-DaCompany Report #US_021189713 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Other Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Gabapentin C Date:11/19/02ISR Number: 4015507-9Report Type:Expedited (15-DaCompany Report #US_021189457 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Literature Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Blood Urea Increased Professional (Olanzapine) PS Diabetes Mellitus Divalproex Sodium C Hyperglycaemic Neurontin Hyperosmolar Nonketotic (Gabapentin) C Syndrome Hydrochlorothiazide C Hypovolaemia Zocor (Simvastatin) C Orthostatic Hypotension Urinary Incontinence Urine Ketone Body Present Weight Decreased Date:11/20/02ISR Number: 4012213-1Report Type:Expedited (15-DaCompany Report #B0285108A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Seroxat PS Glaxo Wellcome ORAL 40MG per day Sudden Death Zyprexa SS ORAL 20MG per day Date:11/20/02ISR Number: 4015265-8Report Type:Expedited (15-DaCompany Report #FR_020701247 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa-Oral Hospitalization - Cytolytic Hepatitis Health (Olanzapine) Initial or Prolonged Dyspnoea Professional (Olanzapine) PS 10 MG/DAY Other Guillain-Barre Syndrome Other Athymil (Mianserin Pulmonary Embolism Hydrochloride) C Weight Increased Zopiclone (Zopiclone) C Xanax (Alprazolam) C Procaine C Feldene (Piroxicam) C Miorel (Thiocolchicoside) C Ketum (Ketoprofen) C Dafalgan (Paracetamol) C 24-Jun-2005 12:19 PM Page: 2114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/02ISR Number: 4015269-5Report Type:Expedited (15-DaCompany Report #EWC021032825 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Fibrinogen Foreign Olanzapine-Oral Initial or Prolonged Increased Health (Olanzapine) PS 5 MG/DAY Hyperglycaemia Professional Fluvoxamine C Laboratory Test Abnormal Other Paresis Parkinsonism Red Blood Cell Sedimentation Rate Increased Rhabdomyolysis Sepsis Urinary Tract Infection Date:11/20/02ISR Number: 4015271-3Report Type:Expedited (15-DaCompany Report #US_020483405 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Study (Olanzapine) PS 15 MG DAY Other Anger Health Wintermin Blood Bilirubin Increased Professional (Chlorpromazine C-Reactive Protein Other Hydrochloride) C Increased Diazepam C Enterocolitis Artane Gamma-Glutamyltransferase (Trihexyphenidyl Increased Hydrochloride) C Gastrointestinal Pyrethia Infection (Promethazine Intestinal Obstruction Hydrochloride) C Irritability Pursennid (Senna Pyrexia Leaf) C Magnesium Oxide C Bioferin R (Streptococcus Faecalis) C Simvastatin C Gaster (Famotidine) C Date:11/20/02ISR Number: 4015730-3Report Type:Expedited (15-DaCompany Report #US_021189647 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Humulin-Human : 30% Initial or Prolonged Cataract Other Regular, 70% Nph PS 48 IU/2 DAY Depression Prozac Dizziness (Fluoxetine Fracture Hydrochloride) SS ORAL Hand Fracture Depakote Osteoporosis (Valproate Rib Fracture Semisodium) SS Somnolence Zyprex Suicidal Ideation (Olanzapine) SS ORAL 15 MG/DAY Actos (Pioglitazone) C Takeda Nitroglycerin (Glyceryl 24-Jun-2005 12:19 PM Page: 2115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trinitrate) C Risperdal (Risperidone) C Anacin C Celebrix (Celecoxib) C Salsalate C Date:11/20/02ISR Number: 4015748-0Report Type:Expedited (15-DaCompany Report #GB9334504NOV2002 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Peroneal Nerve Palsy Foreign Efexor Other Health (Venlafaxine ) PS ORAL SEE IMAGE 27 DAY Professional Zyprexa Other (Olanzapine) SS ORAL 5 MG 1 X PER 1 DAY, ORAL 98 DAY Vitamin B12 (Cyanocobalamin And Derivatives) C Date:11/20/02ISR Number: 4015975-2Report Type:Expedited (15-DaCompany Report #EMADSS2002006938 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Haldol (Solution) Hospitalization - Complete Health (Haloperidol) PS ORAL 0.6 MG, Initial or Prolonged Bronchopneumonia Professional DAILY, ORAL Disability Electrocardiogram Qt Zyprexa (Olanzapine) SS ORAL 2.5 MG, Other Prolonged DAILY, ORAL Required Insomnia Madopar (Madopar) C Intervention to Staphylococcal Infection Symmetrel Prevent Permanent Torsade De Pointes (Amantadine Impairment/Damage Hydrochloride) C Sinemet-Cr (Sinemet) C Aspirine Cardio (Acetylsalicylic Acid) C Concor Cor (Bisoprolol Fumarate) C Dafalgan (Paracetamol) C Imovane (Zopiclone) C Nitroderm Tts (Glyceryl Trinitrate) C Date:11/20/02ISR Number: 4016684-6Report Type:Expedited (15-DaCompany Report #US_021089160 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Olanzapine-Oral Phosphokinase Increased Study (Olanzapine) PS Hepatocellular Damage Health Risperdal Hypercholesterolaemia Professional (Risperidone) C Insomnia Other Akineton (Biperiden Restless Legs Syndrome Hydrochloride) C Contomin 24-Jun-2005 12:19 PM Page: 2116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Chlorpromazine Hydrochloride) C Benzalin (Nitrazepam) C Date:11/20/02ISR Number: 4030799-8Report Type:Periodic Company Report #PHEH2002US03169 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Exelon Professional (Rivastigmine) PS Zyprexa(Olanzapine) SS Date:11/22/02ISR Number: 4013688-4Report Type:Direct Company Report #CTU 181533 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa PS ORAL 15MG PO Glycosylated Haemoglobin QHS-CURRENTLY Increased ON 25MG QHS PO Enalapril C Seroquel C Lorazepam C Metoprolol C Glucotrol Xl C Haldol (Haloperidol) C Congentin (Benztropine) C Prolixin (Fluphenazine) C Depakote (Divalproex) C Risperdal (Risperidone) C Date:11/22/02ISR Number: 4013838-XReport Type:Expedited (15-DaCompany Report #B0285375A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Retrovir PS Glaxo Wellcome ORAL 300MG Unknown 4 YR Initial or Prolonged Phosphokinase Increased Epivir SS Glaxo Wellcome ORAL 150MG Twice per day Crixivan SS ORAL 400MG Twice per day Zyprexa SS ORAL 7.5MG Twice per day Date:11/22/02ISR Number: 4018887-3Report Type:Periodic Company Report #PHEH2002US06571 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozaril Initial or Prolonged Dehydration Professional (Clozapine) PS ORAL 300 MG, QD, Psychotic Disorder ORAL Weight Decreased Zyprexa (Olanzapine) SS Celexa (Citalopram Hydrobromide) SS 24-Jun-2005 12:19 PM Page: 2117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Date:11/25/02ISR Number: 4014719-8Report Type:Direct Company Report #CTU 181596 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anhidrosis Zyprexa 5mg PS ORAL 5MG 1 X AT Fatigue ORAL Heart Rate Increased Muscle Twitching Somnolence Weight Increased Date:11/25/02ISR Number: 4016241-1Report Type:Expedited (15-DaCompany Report #USA021123575 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Zyprexa-Oral Psychotic Disorder Professional (Olanzapine) Rhabdomyolysis Company (Olanzapine) PS Representative Naproxen C Date:11/25/02ISR Number: 4016245-9Report Type:Expedited (15-DaCompany Report #USA021123702 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa-Oral Initial or Prolonged Delusion (Olanzapine) Drug Abuser (Olanzapine) PS 80 MG/DAY Euphoric Mood Hallucination Memory Impairment Paraesthesia Sexual Dysfunction Treatment Noncompliance Date:11/25/02ISR Number: 4016246-0Report Type:Expedited (15-DaCompany Report #US_021189941 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Study Olanzapine-Oral Initial or Prolonged International Normalised Health (Olanzapine) PS 15 MG DAY Ratio Increased Professional Depakene (Valproate Sodium) C Colace (Docusate Sodium) C Captopril C Potassium Chloride C Lasix (Furosemide) C Coumadin (Warfarin Sodium) C Lipitor (Atorvastatin) C 24-Jun-2005 12:19 PM Page: 2118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/02ISR Number: 4016262-9Report Type:Expedited (15-DaCompany Report #USA020921421 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immune System Disorder Health Zyprexa-Oral Phlebitis Professional (Olanzapine) (Olanzapine) PS 15 MG/DAY 2 YR Zoloft (Sertraline Hydrochloride) C Date:11/25/02ISR Number: 4016298-8Report Type:Expedited (15-DaCompany Report #USA020820424 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa Injury Asphyxiation Professional -Oral(Olanzapine) Somnolence Company (Olanzapine) PS 5 MG /DAY Representative Effexor-Xr (Venlafaxine Hydrochloride) C Date:11/25/02ISR Number: 4016301-5Report Type:Expedited (15-DaCompany Report #USA021022972 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Health Zyprexa-Oral Initial or Prolonged Infarction Professional (Olanzapine) Company (Olanzapine) PS 5 MG DAY Representative Date:11/25/02ISR Number: 4017151-6Report Type:Expedited (15-DaCompany Report #US_020987707 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Foreign Olanzapine-Oral Dehydrogenase Increased Health (Olanzapine) PS 10 MG/DAY Eosinophil Count Professional Vegetamin A C Increased Company Depas (Etizolam) C Toxic Epidermal Representative Necrolysis Other White Blood Cell Count Increased Date:11/25/02ISR Number: 4017155-3Report Type:Expedited (15-DaCompany Report #US_021088722 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa-Oral Initial or Prolonged Consciousness Health (Olanzapine) Formication Professional (Olanzapine) PS 100 MG/DAY Intentional Misuse Company Metabolic Acidosis Representative Overdose Other Rhabdomyolysis Somnolence Stress Suicide Attempt Urinary Incontinence 24-Jun-2005 12:19 PM Page: 2119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/02ISR Number: 4017160-7Report Type:Expedited (15-DaCompany Report #DE_020909646 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa-Oral Hospitalization - Difficulty In Walking Health (Olanzapine) Initial or Prolonged Dyspnoea Professional (Olanzapine) PS 20 MG/DAY Generalised Oedema Other Inappropriate Antidiuretic Hormone Secretion Somnolence Date:11/25/02ISR Number: 4017167-XReport Type:Expedited (15-DaCompany Report #FR_020901476 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiospasm Foreign Zyprexa-Oral Initial or Prolonged Foreign Body Trauma Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Effexor (Venlafaxine Hydrochloride) C Valium (Diazepam) C Atarax (Hydroxyzine Hydrochloride) C Depamide (Valpromide) C Lasilix (Furosemide) C Date:11/25/02ISR Number: 4017321-7Report Type:Expedited (15-DaCompany Report #GBS021111938 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Olanzapine-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) PS 15 MG/DAY Professional Lorazepam C Other Haloperidol C Date:11/25/02ISR Number: 4017361-8Report Type:Expedited (15-DaCompany Report #USA021123731 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) Other (Olanzapine) PS Zoloft (Sertraline Hydrochloride) C Date:11/25/02ISR Number: 4017386-2Report Type:Expedited (15-DaCompany Report #US_021189930 Age:67 YR Gender:Female I/FU:I Outcome PT Life-Threatening Blood Creatinine Hospitalization - Increased Initial or Prolonged Cellulitis Other Coma Disorientation Fall 24-Jun-2005 12:19 PM Page: 2120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Enzyme Increased Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Respiratory Distress Health Zyprexa-Oral Tremor Professional (Olanzapine) Urinary Incontinence (Olanzapine) PS 10 MG/DAY Vancomycin-Intraveno us Formulation (Vancomycin Hydr SS Effexor (Venlafaxine Hydrochloride) C Xanax (Alprazolam) C Lithium C Dalmane (Flurazepam Hydrochloride) C Paxil (Paroxetine Hydrchloride) C Date:11/25/02ISR Number: 4017414-4Report Type:Expedited (15-DaCompany Report #EMADSS2002006938 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Haldol (Solution) Hospitalization - Complete Health (Haloperidol) PS ORAL 0.6 MG, Initial or Prolonged Bronchopneumonia Professional DAILY, ORAL Disability Electrocardiogram Qt Zyprexa (Olanzapine) SS ORAL 2.5 MG, Other Prolonged DAILY, ORAL Required Electrocardiogram T Wave Madopar (Madopar) C Intervention to Abnormal Symmetrical Prevent Permanent Staphylococcal Infection (Amantadine Impairment/Damage Torsade De Pointes Hydrochloride) C Sinemet-Cr (Sinemet) C Aspirine Cardio (Acetylsalicylic Acid) C Concor Cor (Bisoprolol Fumarate) C Dafalgan (Paracetamol) C Imovane (Zopiclone) C Nitroderm Tts (Glyceryl Trinitrate) C Date:11/25/02ISR Number: 4017437-5Report Type:Expedited (15-DaCompany Report #DE_021110076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa-Oral Initial or Prolonged Liver Disorder Health (Olanzapine) Professional (Olanzapine) PS Company Cipramil (Citalopram Representative Hydrobromide) C Other 24-Jun-2005 12:19 PM Page: 2121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/02ISR Number: 4017441-7Report Type:Expedited (15-DaCompany Report #DE_021110078 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Tiapridex (Tiapride Hydrochloride) C Bronchoretard (Theophylline) C Norvasc (Amlodipine Besilate) C Arelix (Piretanide) C Delix (Ramipril) C Aldactone (Spironolactone) C Date:11/25/02ISR Number: 4017443-0Report Type:Expedited (15-DaCompany Report #GBS021111945 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Zyprexa-Oral Sudden Death Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Seroxat (Paroxetine Hydrochloride) C Date:11/25/02ISR Number: 4017444-2Report Type:Expedited (15-DaCompany Report #FR_021101642 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa-Oral Initial or Prolonged Bradypnoea Health (Olanzapine) Drug Level Increased Professional (Olanzapine) PS Hyperammonaemia Other Imovane (Zopiclone) C Hypotension Depakote (Valproate Syncope Semisodium) C Temesta (Lorazepam) C Diamicron (Gliclazide) C Zoloft (Sertraline Hydrochloride) C Metformine C Trimetazidine C Date:11/25/02ISR Number: 4017445-4Report Type:Expedited (15-DaCompany Report #FR_021101660 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) Blood Lactate Professional (Olanzapine) PS 5 MG/DAY Dehydrogenase Increased Company Prozac (Fluoxetine Coma Representative Hydrochloride) C Heat Stroke Other 24-Jun-2005 12:19 PM Page: 2122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/02ISR Number: 4017446-6Report Type:Expedited (15-DaCompany Report #FR_021101663 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Purpura Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Tercian (Cyamemazine) C Theralene (Alimemazine Tartrate) C Date:11/25/02ISR Number: 4017447-8Report Type:Expedited (15-DaCompany Report #GBS021011832 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Date:11/25/02ISR Number: 4017448-XReport Type:Expedited (15-DaCompany Report #EWC020832096 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine-Oral Chest Pain Health (Olanzapine) PS 20 MG/DAY Professional Haloperidol C Other Diazepam C Date:11/26/02ISR Number: 4018059-2Report Type:Expedited (15-DaCompany Report #2002067049 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Health Phenelzine Sulfate Other Difficulty In Walking Professional (Phenelzine Sulfate) PS Malaise Benadryl Injection Mitral Valve Disease (Diphenydramine) SS Poverty Of Speech Olanzapine SS Pulmonary Oedema Alprazolam SS Respiratory Disorder Lamotrigine SS Benzatropine Mesilate SS Zolpidem Tartrate C Date:11/29/02ISR Number: 4019146-5Report Type:Expedited (15-DaCompany Report #EMADSS2002007164 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Haldol (2 Mg/Ml Initial or Prolonged Atrial Fibrillation Health Liquid) Rhabdomyolysis Professional (Haloperidol) PS ORAL 12 MG, DAILY, ORAL Depakine (Valproate Sodium) SS ORAL 400 MG, DAILY, ORAL Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, 24-Jun-2005 12:19 PM Page: 2123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Tercian (Cyamemazine) SS ORAL 200 MG, DAILY, ORAL Date:11/29/02ISR Number: 4019888-1Report Type:Expedited (15-DaCompany Report #02P-062-0204412-00 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Akineton Retard Initial or Prolonged Health (Biperiden) PS ORAL 4 MG, 1 IN 1 Professional D, PER ORAL, 4 MG 2 IN 1 DAY PER ORAL Ziprasidone Hydrochloride SS ORAL SEE IMAGE ORAL Olanzapine SS OPHTHALMIC SEE IMAGE ORAL Lorazepam C Date:12/02/02ISR Number: 4017521-6Report Type:Expedited (15-DaCompany Report #D0039829A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Quilonum Retard PS Glaxo Wellcome ORAL 450MG Unknown 3 DAY Initial or Prolonged Drug Interaction Professional Zyprexa SS ORAL 2 DAY Drug Level Increased Laubeel C ORAL 30 DAY Date:12/03/02ISR Number: 4020707-8Report Type:Expedited (15-DaCompany Report #US_021089358 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cervical Vertebral Foreign Zyprexa-Oral Other Fracture Health (Olanzapine) Completed Suicide Professional (Olanzapine) PS 10 MG/DAY Condition Aggravated Company Eurodin (Estazolam) C Crying Representative Levomepromazine C Delusion Other Biperiden C Hallucination, Auditory Propitan Restlessness (Pipamperone) C Date:12/03/02ISR Number: 4020715-7Report Type:Expedited (15-DaCompany Report #USA021022302 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Consumer Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Confusional State Professional (Olanzapine) PS 15 MG/DAY Other Constipation Company Lithium C Death Representative Effexor-Xr Diabetic Coma (Venlafaxine Incontinence Hydrochloride) C Renal Failure Acute 24-Jun-2005 12:19 PM Page: 2124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4021004-7Report Type:Expedited (15-DaCompany Report #US_000439191 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Appetite Consumer Prozac-Oral Drug Abuser Company (Fluoxetine) Drug Screen Positive Representative (Fluoxetine Excitability Hydrochloride) PS 20 MG/DAY Medication Error Zyprexa-Oral Murder (Olanzapine) Oral Intake Reduced (Olanzapine) SS 10 MG/DAY Physical Assault Ritalin Psychotic Disorder (Methylphenidate Schizophrenia, Paranoid Hydrochloride) C Type Klonopn (Clonazepam) C Somnolence Desyrel (Trazodone Suicidal Ideation Hydrochloride) C Treatment Noncompliance Luvox (Fluvoxamine Maleate) C Date:12/03/02ISR Number: 4021054-0Report Type:Expedited (15-DaCompany Report #2002066177 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Geodon (Ziprasidone) PS 160 MG (TWICE Chest Pain Professional A DAY) Dyspnoea Exertional Company Olanzapine SS 25 MG (DAILY) Electrocardiogram Qt Representative Liothyronine Sodium C Corrected Interval Lorazepam C Prolonged Citalopram Epistaxis Hydrobromide C Nausea Palpitations Vomiting Date:12/03/02ISR Number: 4021079-5Report Type:Expedited (15-DaCompany Report #USA020921267 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aplastic Anaemia Health Zyprexa-Oral Hospitalization - Bone Marrow Depression Professional (Olanzapine) Initial or Prolonged Gout Company (Olanzapine) PS 5 MG/DAY Other Pancytopenia Representative Vancomycin-Iv Pyrexia (Vancomycin) Renal Impairment (Vancomycin Squamous Cell Carcinoma Hydrochlorid SS Hytrin (Terazosin Hydrochloride) C Cardizem (Diltiazem Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Acetaminophen C Celexa (Citalopram Hydrobromide) C Wellbutrin (Amfebutamone Hydrochloride) C Vitamin B12 C Colchicine C 24-Jun-2005 12:19 PM Page: 2125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Allopurinol C Diflucan (Fluconazole) C Antibiotic C Radiation Therapy C Date:12/03/02ISR Number: 4021313-1Report Type:Expedited (15-DaCompany Report #US_021189528 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Foreign Zyprexa Other Coma Health (Olanzapine) PS 10 MG/DAY Hypothermia Professional Halosten Liver Function Test Company (Haloperidol) C Abnormal Representative Serenace Oliguria Other (Haloperidol) C Pyrethia (Promethazine Hydrochloride) C Hirnamin (Levomepromazine) C Sepazon (Cloxazolam) C Akineton (Biperiden Hydrochloride) C Toughmac E C Vegetamin A C Pursennid (Senna Leaf) C Date:12/03/02ISR Number: 4021315-5Report Type:Expedited (15-DaCompany Report #EWC020731709 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Olanzapine-Oral Other Neuroleptic Malignant Health (Olanzapine) PS 10 MG/DAY Syndrome Professional Diazepam C Company Representative Other Date:12/03/02ISR Number: 4021316-7Report Type:Expedited (15-DaCompany Report #GBS021111938 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Bilirubin Increased Foreign Olanzapine Blood Lactate Health (Olanzapine) PS 15 MG/DAY Dehydrogenase Abnormal Professional Lorazepam C Condition Aggravated Other Haloperidol C Date:12/03/02ISR Number: 4021317-9Report Type:Expedited (15-DaCompany Report #GBS021011832 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Chronic Foreign Zyprexa Initial or Prolonged Liver Function Test Health (Olanzapine) PS ORAL 20 MG Abnormal Professional Pancreatitis Other 24-Jun-2005 12:19 PM Page: 2126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/02ISR Number: 4019374-9Report Type:Direct Company Report #CTU 182133 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Zoloft PS Initial or Prolonged Zyprexia SS Etoh SS Ibuprofen C Olanzepine C Sertraline C Date:12/04/02ISR Number: 4021551-8Report Type:Expedited (15-DaCompany Report #DE9357728NOV2002 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Tavor (Lorazepam, Initial or Prolonged Miosis Professional Tablet, 0) PS ORAL 20 TABLETS Sedation (OVERDOSE AMOUNT 10 MG) 1 DAY Lendormin (Brotizolam, , 0) SS ORAL 20 TABLETS (OVERDOSE AMOUNT 5.0 MG) 1 DAY Remergil (Mirtazapine, , 0) SS ORAL 10 TABLETS (OVERDOSE AMOUNT 300MG) 1 DAY Stilnox (Zolpidem, , 0) SS ORAL 6 TABLETS (OVERDOSE AMOUNT 60 MG) 1 DAY Tafil (Alprazolam, 0) SS ORAL 1.5 TABLETS (OVERDOSE AMOUNT 0.75MG) 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 26 TABLETS (OVERDOSE AMOUNT 65 MG) 1 DAY Date:12/04/02ISR Number: 4021949-8Report Type:Expedited (15-DaCompany Report #USA021123830 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zyprexa-Oral Influenza Like Illness Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Neurontin (Gabapentin) C Trilafon (Perphenazine) C Methadone C 24-Jun-2005 12:19 PM Page: 2127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/02ISR Number: 4021951-6Report Type:Expedited (15-DaCompany Report #USA020819443 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Urea Increased Health Zyprexa-Oral Hospitalization - Dehydration Professional (Olanzapine) Initial or Prolonged Diabetes Mellitus Company (Olanzapine) PS 5 MG/DAY 6 WK Hypotension Representative Glyburide C Sepsis Date:12/04/02ISR Number: 4021970-XReport Type:Expedited (15-DaCompany Report #USA021123892 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Zyprexa-Oral Other Professional (Olanzapine) Company (Olanzapine) PS Representative Diflucan (Fluconazole) C Date:12/04/02ISR Number: 4021971-1Report Type:Expedited (15-DaCompany Report #USA021123960 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Zyprexa-Oral Other Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Date:12/04/02ISR Number: 4021976-0Report Type:Expedited (15-DaCompany Report #US_021190277 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Zyprexa-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS Representative Date:12/04/02ISR Number: 4021988-7Report Type:Expedited (15-DaCompany Report #US_021190049 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Zyprexa-Oral Initial or Prolonged Hypoglycaemic Coma Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Adderall C Date:12/04/02ISR Number: 4021991-7Report Type:Expedited (15-DaCompany Report #US_021190146 Age:32 YR Gender:Male I/FU:I Outcome PT Death Blood Bicarbonate Hospitalization - Decreased Initial or Prolonged Bradycardia Other Brain Death Diabetic Ketoacidosis Hyperventilation Pco2 Abnormal 24-Jun-2005 12:19 PM Page: 2128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Fibrillation Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 2.5 MG/DAY Date:12/04/02ISR Number: 4021993-0Report Type:Expedited (15-DaCompany Report #US_021190052 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa-Oral Hospitalization - Congestive Professional (Olanzapine) Initial or Prolonged Catatonia Company (Olanzapine) PS 20 MG/DAY Dehydration Representative Zyprexa Muscle Rigidity Zydis-Dispersible Oral Intake Reduced (Olanzapine) Pleural Effusion (Olanzapine) SS 20 MG/DAY Pyrexia Anti-Depressant C Renal Failure Tachycardia Tremor Date:12/04/02ISR Number: 4022304-7Report Type:Expedited (15-DaCompany Report #EWC021133102 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Olanzapine-Oral Life-Threatening Drug Abuser Health (Olanzapine) PS 30 MG/DAY Hospitalization - Drug Detoxification Professional Nozinan Initial or Prolonged Drug Toxicity Other (Levomepromazine) SS Euphoric Mood Zyrtec (Cetirizine Lipomatosis Hydrochloride) C Pulmonary Oedema Oxymetazoline Respiratory Disorder Hydrochloride C Tongue Disorder Skinoren (Azelaic Tongue Oedema Acid) C Tonsillar Hypertrophy Weight Increased Date:12/04/02ISR Number: 4022305-9Report Type:Expedited (15-DaCompany Report #EWC021133069 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Olanzapine-Oral Hospitalization - Complete Health (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Bradycardia Professional Haloperidol C Convulsion Other Madopar C Pneumonia Staphylococcal Symmetrel Torsade De Pointes (Amantadine Hydrochloride) C Sinemet Cr C Aspirin C Ceftriaxone C Dafalgan (Paracetamol) C Imovane(Zopiclone) C Nitroderm 24-Jun-2005 12:19 PM Page: 2129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tts(Glyceryl Trinitrate) C Stilnox(Zolpidem) C Date:12/04/02ISR Number: 4022307-2Report Type:Expedited (15-DaCompany Report #EWC021133144 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Olanzapine-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) PS 20 MG/DAY Exposure To Therapeutic Professional Stilnox (Zolpidem) C Drugs Other Ventolin Condition Aggravated (Salbutamol) C Hypoaesthesia Prothiazine Pregnancy (Promethazine Hydrochloride) C Date:12/04/02ISR Number: 4022308-4Report Type:Expedited (15-DaCompany Report #EWC021133121 Age:28 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Status Epilepticus Foreign Zyprexa-Oral Hospitalization - Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG/DAY Company Depakine (Valproate Representative Sodium) C Other Lamictal (Lamotrigine) C Date:12/04/02ISR Number: 4022310-2Report Type:Expedited (15-DaCompany Report #AU_021105680 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Foreign Zyprexa-Oral Initial or Prolonged Prescribed Overdose Health (Olanzapine) Professional (Olanzapine) PS 30 MG/IN THE Other EVENING 4 YR Lithium C Risperidone C Nizatidine C Diazepam C Date:12/04/02ISR Number: 4022312-6Report Type:Expedited (15-DaCompany Report #AU_021105679 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Consumer (Olanzapine) Delusion Other (Olanzapine) PS 15 MG/DAY Obsessive-Compulsive Disorder 24-Jun-2005 12:19 PM Page: 2130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/02ISR Number: 4022314-XReport Type:Expedited (15-DaCompany Report #US_021190054 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Olanzapine-Oral Completed Suicide Health (Olanzapine) PS 5 MG/AT Hyperglycaemia Professional BEDTIME Irritability Company Vegetamin A C Obsessive-Compulsive Representative Disorder Other Suicidal Ideation Date:12/04/02ISR Number: 4022324-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB03848 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Carbamazepine Non-Insulin-Dependent Health (Carbamazepine) Professional Unknown PS ORAL 800 MG/DAY, Other ORAL Zyprexa (Olanzapine) SS ORAL 10 MG/DAY, ORAL Venlafaxine ( Venlafaxine) SS ORAL 150 MG/DAY, ORAL Date:12/04/02ISR Number: 4022353-9Report Type:Expedited (15-DaCompany Report #US_020685058 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Zyprexa-Oral Initial or Prolonged Hallucination, Auditory Health (Olanzapine) Other Persecutory Delusion Professional (Olanzapine) PS 20 MG/DAY Restlessness Company Parlodel Rhabdomyolysis Representative (Bromocriptine Other Mesilate) C Rohypnol (Flunitrazepam) C Date:12/04/02ISR Number: 4022425-9Report Type:Expedited (15-DaCompany Report #DE_021110134 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Blood Alkaline Health (Olanzapine) Phosphatase Increased Professional (Olanzapine) PS 20 MG/DAY Liver Function Test Other Aquaphor C Abnormal Ultrasound Scan Abnormal Urinary Tract Infection Date:12/04/02ISR Number: 4022438-7Report Type:Expedited (15-DaCompany Report #USA021124027 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Surgery Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY 24-Jun-2005 12:19 PM Page: 2131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor (Venlafaxine Hydrochloride) C Neurontin (Gabapentin C Trazadone (Trazodone) C Date:12/04/02ISR Number: 4022462-4Report Type:Expedited (15-DaCompany Report #DE_021110138 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa-Oral Initial or Prolonged Company (Olanzapine) Representative (Olanzapine) PS 20 MG/DAY Date:12/04/02ISR Number: 4022465-XReport Type:Expedited (15-DaCompany Report #USA021123964 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa-Oral Ear Haemorrhage Professional (Olanzapine) Hyperhidrosis (Olanzapine) PS 10 MG/DAY Topamax (Topiramate) C Effexor (Venlafaxine Hydrochloride) C Clonazepam C Date:12/04/02ISR Number: 4022470-3Report Type:Expedited (15-DaCompany Report #DE_021110127 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Zyprexa-Oral Initial or Prolonged Phosphatase Increased Health (Olanzapine) Blood Lactate Professional (Olanzapine) PS 20 MG/DAY Dehydrogenase Increased Other Atosil(Isopromethazi Liver Function Test ne Hydrochloride) C Abnormal Date:12/04/02ISR Number: 4022472-7Report Type:Expedited (15-DaCompany Report #DE_021110098 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Zyprexa-Oral Hospitalization - Asthenia Health (Olanzapine)(Olanzap Initial or Prolonged Dizziness Professional ine) PS ORAL 5 MG/DAY 5 YR Fatigue Company Hypnorex(Lithium Infection Representative Carbonate) C Leukocytosis Cipramil(Citalopram Malaise Hydrobromide) C Weight Decreased 24-Jun-2005 12:19 PM Page: 2132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/02ISR Number: 4022473-9Report Type:Expedited (15-DaCompany Report #CA_021105525 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Decreased Foreign Zyprexa-Oral Initial or Prolonged Drug Level Increased Health (Olanzapine)(Olanzap Liver Function Test Professional ine) PS ORAL 20 MG/AT Abnormal Other BEDTIME Neutropenia Benadryl(Diphenhydra Thrombocytopenia mine Hydrochloride) C Orap(Pimozide) C Valium(Diazepam) C Valproic Acid C Date:12/04/02ISR Number: 4022475-2Report Type:Expedited (15-DaCompany Report #US_021088871 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disseminated Foreign Zyprexa-Oral Other Intravascular Coagulation Health (Olanzapine) Hypoglycaemia Professional (Olanzapine) PS ORAL 20 MG/DAY Company Solanax(Alprazolam) C Representative Artist (Carvedilol) C Other Cibenol(Cibenzoline Succinate) C Mendon(Clorazepate Dipotassium) C Date:12/04/02ISR Number: 4022476-4Report Type:Expedited (15-DaCompany Report #GBS021111983 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Ph Decreased Foreign Zyprexa-Oral Initial or Prolonged Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS ORAL 700 MG/DAY Hypotension Other Efexor(Venlafaxine Intentional Misuse Hydrochloride) C Po2 Decreased Pulmonary Function Test Decreased Date:12/04/02ISR Number: 4022494-6Report Type:Expedited (15-DaCompany Report #EWC021133117 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 5 MG/DAY Required Professional Surmontil Intervention to Company (Trimipramine) C Prevent Permanent Representative Tegretol Impairment/Damage Other (Carbamazepine) C Rivotril (Clonazepam) C Meleril (Thioridazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/02ISR Number: 4022592-7Report Type:Expedited (15-DaCompany Report #DE9357728NOV2002 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Tavor (Lorazepam, Initial or Prolonged Miosis Professional Tablet, 0) PS ORAL 20 TABLETS Sedation (OVERDOSE Somnolence AMOUNT 10 MG), ORAL 1 DAY Lendormin (Brotizolam, 0) SS ORAL 20 TABLETS (OVERDOSE AMOUNT 5.0 MG), ORAL 1 DAY Remergil (Mirtazapine , 0) SS ORAL 10 TABLETS (OVERDOSE AMOUNT 300 MG), ORAL 1 DAY Stilnox (Zolpidem, 0) SS ORAL 6 TABLETS (OVERDOSE AMOUNT 60 MG), ORAL 1 DAY Tafil (Alprazolam, 0) SS ORAL 1.5 TABLETS (OVERDOSE AMOUNT 0.75 MG) , ORAL 1 DAY Zyprexa (Olanzapine, 0) SS ORAL 26 TABLETS (OVERDOSE AMOUNT 65 MG), ORAL 1 DAY Date:12/06/02ISR Number: 4020267-1Report Type:Direct Company Report #CTU 182254 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Clozapine 25mg Ivax PS Ivax 25mg ORAL 25MG AM AND Initial or Prolonged Syndrome HS ORAL Olanzapine 20mg Lilly SS Lilly ORAL 20MG 5 PM ORAL Date:12/06/02ISR Number: 4022613-1Report Type:Expedited (15-DaCompany Report #B0285159A Age:43 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Literature Diphenhydramine Health Hydrochloride Professional (Formulation Unknown) (Diphenhydramine PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Fluoxetine (Formulation 24-Jun-2005 12:19 PM Page: 2134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unknown) (Fluoxetine) SS ORAL ORAL Date:12/06/02ISR Number: 4025867-0Report Type:Direct Company Report #CTU 182238 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Olanzepine 5mg PS ORAL 5 QD ORAL Syndrome Citalopram C Acetazolimide C Clonazepam C Carbamazepine C Senekot C Tylenol C Asa C Thiamine C Tenormin C Mvi C Date:12/09/02ISR Number: 4023135-4Report Type:Expedited (15-DaCompany Report #2002068666 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stupor Foreign Cetirizine (Tablets) Initial or Prolonged Suicide Attempt Health (Cetirizine Professional Hydrochloride) PS ORAL ORAL Olanzapine SS ORAL ORAL Paracetamol SS ORAL ORAL Metamizole Sodium SS ORAL ORAL Date:12/10/02ISR Number: 4024307-5Report Type:Expedited (15-DaCompany Report #USA020617353 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa-Oral Professional (Olanzapine)(Olanzap ine) PS 15 MG/AT BEDTIME Date:12/10/02ISR Number: 4024697-3Report Type:Expedited (15-DaCompany Report #USA021124047 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Humalog-. (Lispro) PS Initial or Prolonged Aphasia Zyprexa-Oral Other Depression (Olanzapine) Diabetes Mellitus (Olanzapine) SS 15 MG/DAY 11 MON Inadequate Control Lantus (Insulin Diabetic Coma Glargine) C Suicide Attempt Wellbutrin Treatment Noncompliance (Amfebutamone Tremor Hydrochloride) C Levothyroxine C 24-Jun-2005 12:19 PM Page: 2135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/02ISR Number: 4024807-8Report Type:Expedited (15-DaCompany Report #CA_020204815 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Prolactin Increased Foreign Olanzapine-Oral Life-Threatening Blood Urine Present Study (Olanzapine) PS 20 MG Hospitalization - Body Temperature Health Hydrochlorothiazide C Initial or Prolonged Increased Professional Coversyl Other Extrapyramidal Disorder Other (Perindopril) C Fatigue Salbutamol C Leukaemia Myelodysplastic Syndrome Myeloid Metaplasia Neutropenia Pancytopenia Pneumonia Pyrexia Streptococcal Sepsis Date:12/10/02ISR Number: 4024808-XReport Type:Expedited (15-DaCompany Report #US_021088722 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 100 MG/DAY Aminotransferase Company Increased Representative Blood Lactate Other Dehydrogenase Increased Depressed Level Of Consciousness Formication Intentional Misuse Metabolic Acidosis Rhabdomyolysis Somnolence Stress Suicide Attempt Date:12/10/02ISR Number: 4024809-1Report Type:Expedited (15-DaCompany Report #US_020281727 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Representative Other Date:12/10/02ISR Number: 4024810-8Report Type:Expedited (15-DaCompany Report #US_020281759 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Death Cerebrovascular Accident Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 2136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:12/10/02ISR Number: 4024948-5Report Type:Expedited (15-DaCompany Report #USA021124251 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diet Refusal Health Zyprexa-Oral Medication Error Professional (Olanzapine) Oesophageal Stenosis (Olanzapine) PS 20 MG/DAY Zyprexa Zydis-Dispersible (Olanzapine) (Olanzapine) SS 12.5 MG/DAY Date:12/10/02ISR Number: 4024950-3Report Type:Expedited (15-DaCompany Report #USA021124267 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa-Oral Initial or Prolonged Vomiting (Olanzapine) (Olanzapine) PS Zyprexa Zydis-Dispersible (Olanzapine) (Olanzapine) SS 40 MG/DAY Haldol (Haloperidol) C Clonazepam C Lorazepam C Metformin C Date:12/10/02ISR Number: 4025047-9Report Type:Expedited (15-DaCompany Report #USA021124210 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Osteoarthritis Consumer Humulin-Human Suicidal Ideation Insulin (Rdna): 30% Tremor Regular, 70% Nph (H PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG/DAY Levoxyl (Levothyroxine Sodium) C Accupril (Quinipril Hydrochloride) C Vioxx (Rofecoxib) C Avandia (Rosiglitazone Maleate) C Metformin C Lithium C Lorazepam C Diazepam C 24-Jun-2005 12:19 PM Page: 2137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin C Atenolol C Date:12/10/02ISR Number: 4025058-3Report Type:Expedited (15-DaCompany Report #FR_021101709 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS OTHER 10 MG/OTHER Other Loxapac (Loxapine Succinate) C Tercian (Cyamemazine) C Date:12/10/02ISR Number: 4025092-3Report Type:Expedited (15-DaCompany Report #EWC021133130 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa-Oral Initial or Prolonged Haematoma Health (Olanzapine)(Olanzap Humerus Fracture Professional ine) PS ORAL 10 MG Hyponatraemia Other Fluanxol Pneumonia (Flupentixol Dihydrochloride) C Buspar (Buspirone Hydrochloride) C Oxascand (Oxazepam) C Disipal (Orphenadrime Hydrochloride) C Lanzo (Lansoprazole) C Propavan (Propiomazine Maleate) C Zoloft (Sertraline Hydrochloride) C Date:12/10/02ISR Number: 4025097-2Report Type:Expedited (15-DaCompany Report #FR-021101710 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Zyprexa-Oral Initial or Prolonged Atrial Fibrillation Health (Olanzapine)(Olanzap Rhabdomyolysis Professional ine) PS 10 MG/DAY Other Depakine (Valproate Sodium) C Haldol (Haloperidol) C Tercian (Cyamemazine) C Date:12/10/02ISR Number: 4025099-6Report Type:Expedited (15-DaCompany Report #DE_021110235 Age: Gender:Female I/FU:I Outcome PT Report Source Amenorrhoea Foreign Menorrhagia Consumer 24-Jun-2005 12:19 PM Page: 2138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa- Oral (Olanzapine)(Olanzap ine) PS ORAL 20 MG/DAY Date:12/10/02ISR Number: 4025187-4Report Type:Expedited (15-DaCompany Report #GBS021011722 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Oral Hospitalization - Congestive Health (Olanzapine)(Olanzap Initial or Prolonged Dilatation Ventricular Professional ine) PS 10 MG/2 AT Ventricular Hypertrophy Other BEDTIME Haloperidol C Salmeterol Xinafoate C Diprosone(Betamethas one Dipropionate) C Salamol(Salbutamol Sulfate) C Beclomethasone Dipropionate C Salbutamol C Carbamazepine C Venlafaxine Hydrochloride C Date:12/10/02ISR Number: 4025218-1Report Type:Expedited (15-DaCompany Report #US_021190285 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Foreign Olanzapine-Oral Hospitalization - Hyponatraemia Study (Olanzapine) PS 20 MG DAY Initial or Prolonged Injury Asphyxiation Health Haloperidol C Vomiting Professional Zotepine C Other Biperiden C Brotizolam C Flunitrazepam C Date:12/10/02ISR Number: 4025219-3Report Type:Expedited (15-DaCompany Report #FR_021101707 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Foreign Zyprexa-Oral Initial or Prolonged Blood Sodium Increased Health (Olanzapine) Dehydration Professional (Olanzapine) PS 20 MG/DAY Hyperglycaemia Other Hyperosmolar State Renal Failure Acute Thrombocytopenia 24-Jun-2005 12:19 PM Page: 2139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/02ISR Number: 4025557-4Report Type:Expedited (15-DaCompany Report #FR_021001498 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Foreign Zyprexa-Oral Hepatocellular Damage Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Prozac (Fluoxetine Hydrochloride) C Stilnox (Zolpidem) C Xanax (Alprazolam) C Topalgic (Tramadol Hydrochloride) C Cacit C Date:12/11/02ISR Number: 4021748-7Report Type:Direct Company Report #CTU 182532 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Zyprexa PS Platelet Count Abnormal Risperdal SS Red Blood Cell Count Glipizide C Abnormal Mvi C Red Cell Distribution Trazadone C Width Increased Zyprexa C White Blood Cell Count Ilithium C Abnormal Date:12/11/02ISR Number: 4022078-XReport Type:Direct Company Report #CTU 182503 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Zyprexa 15mg Lilly PS Lilly ORAL 15MG PO QHS Date:12/11/02ISR Number: 4024216-1Report Type:Expedited (15-DaCompany Report #02P-151-0205406-00 Age:33 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Foreign Depakine (Depakene) Intervention to Drug Interaction Health (Sodium Prevent Permanent Tremor Professional Valproate/Valproic Impairment/Damage Acid) (Sodium Valproate/Valproic PS ORAL 1500 MG, 1 IN 1 D, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 D, PER ORAL; 5 MG, 1 IN 1 D, PER ORAL Reboxetine SS ORAL 4 MG, 1 IN 1 D, PER ORAL Citalopram Hydrobromide SS ORAL 20 MG, 1 IN 1 D, PER ORAL Zopiclone SS ORAL 7.5 MG, 1 IN 1 D, PER ORAL Bromazepam SS ORAL 3 MG, 1 IN 1 D, PER ORAL Propranolol Hydrochloride SS ORAL 40 MG, 1 IN 1 24-Jun-2005 12:19 PM Page: 2140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D, PER ORAL Date:12/12/02ISR Number: 4022897-XReport Type:Direct Company Report #CTU 182608 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Prozac Once Weekly PS ORAL ONCE WEEKLY Completed Suicide ORAL Thinking Abnormal Zyprexa SS ORAL ORAL Date:12/13/02ISR Number: 4023538-8Report Type:Direct Company Report #CTU 182681 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Olanzapine 17.5 Mg PS 17.5 MG QD Intervention to Increased Prevent Permanent Impairment/Damage Date:12/13/02ISR Number: 4025819-0Report Type:Direct Company Report #CTU 182807 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Zyprex PS OUTPT RX Initial or Prolonged Hyponatraemia Maxizide C Date:12/13/02ISR Number: 4026413-8Report Type:Expedited (15-DaCompany Report #S02-SWI-03383-01 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Erectile Dysfunction Foreign Seropram (Citalopram Testicular Pain Health Hydrobromide) PS ORAL 20 MG QD PO Professional Zyprexa (Olanzapine) SS ORAL 17.5 MG QD PO Other Date:12/13/02ISR Number: 4027160-9Report Type:Expedited (15-DaCompany Report #02P-163-0205468-00 Age:25 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Valproic Acid Completed Suicide Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Date:12/13/02ISR Number: 4027164-6Report Type:Expedited (15-DaCompany Report #02P-163-0205470-00 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Valproic Acid Completed Suicide Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS ORAL PER ORAL Bupropion SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL 24-Jun-2005 12:19 PM Page: 2141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/02ISR Number: 4027135-XReport Type:Expedited (15-DaCompany Report #02P-056-0205684-00 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Depakine Tablets Initial or Prolonged Atrial Fibrillation Health (Sodium Valproate) Rhabdomyolysis Professional (Sodium Valproate) Tachycardia (Sodium Valproate) PS ORAL 400 MG, 1 IN 1 D, ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 D, ORAL Haloperidol SS ORAL 12 MG, 1 IN 1 D, ORAL Cyamemazine SS 200 MG, 1 IN 1 D Date:12/17/02ISR Number: 4026081-5Report Type:Direct Company Report #CTU 182781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Zyprexa (Olanzipine) PS Required Intervention to Prevent Permanent Impairment/Damage Date:12/17/02ISR Number: 4026100-6Report Type:Direct Company Report #CTU 182809 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cutaneous Lupus Dilantin 100mg Caps PS 200MG BID Erythematosus Zyprexa 5mg Tabs SS 5MG QHS Systemic Lupus Erythematosus Date:12/17/02ISR Number: 4028006-5Report Type:Expedited (15-DaCompany Report #021212-PM0015-00 Age:48 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clorazepate Health Dipotassium Professional (Tranxene) PS ORAL P.O. Other Modafinil SS ORAL P.O. Olanzapine SS ORAL P.O. Date:12/18/02ISR Number: 4025728-7Report Type:Direct Company Report #CTU 183009 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Risperdal 1mg Jannsa PS Jannson SEE DESCRIBE EVENT Zyprexa 20mg Lilly SS Lilly SEE DESCRIBE EVENT Lithum 300mg Roche SS Roche Paxil C Synthroid C Lopid C Benadryl C 24-Jun-2005 12:19 PM Page: 2142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metamucil C Cogentin C Ativan C Prolixin C Altace C Date:12/18/02ISR Number: 4025825-6Report Type:Direct Company Report #CTU 182886 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glycosylated Haemoglobin Olanzapine 5 Mg PS ORAL 5MG DAILY Initial or Prolonged Increased ORAL Hyperglycaemia Metformin C Paxil C Zyprexa C Date:12/18/02ISR Number: 4029108-XReport Type:Expedited (15-DaCompany Report #USA021022727 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral(Olanzap Initial or Prolonged Alcoholic Hangover Health ine)(Olanzapine) PS 40 MG/DAY Bipolar Disorder Professional Lithobid(Lithium Drug Abuser Carbonate) C Feeling Abnormal Trazodone C Hunger Insomnia Mental Disorder Oedema Peripheral Paranoia Pyromania Treatment Noncompliance Weight Increased Date:12/18/02ISR Number: 4029126-1Report Type:Expedited (15-DaCompany Report #US_011075894 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Literature Zyprexa(Olanzapine) PS Contusion Health Benztropine C Drug Toxicity Professional Lorazepam C Excoriation Clonazepam C Laceration Pulmonary Congestion Pulmonary Fibrosis Pulmonary Haemorrhage Pulmonary Oedema Renal Disorder Spleen Congestion Thymus Disorder Date:12/18/02ISR Number: 4029239-4Report Type:Expedited (15-DaCompany Report #EWC021133130 Age:25 YR Gender:Male I/FU:F Outcome PT Hospitalization - Fall Initial or Prolonged Haematoma 24-Jun-2005 12:19 PM Page: 2143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humerus Fracture Hyponatraemia Pneumonia Report Source Product Role Manufacturer Route Dose Duration Water Intoxication Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Fluanxol (Flupentixol Dihydrochloride) C Buspar (Buspirone Hydrochloride) C Oxascand (Oxazepam) C Disipal (Orphenadrine Hydrochloride) C Lanzo (Lansoprazole) C Propavan (Propiomazine Maleate) C Zoloft (Sertraline Hydrochloride) C Date:12/18/02ISR Number: 4029241-2Report Type:Expedited (15-DaCompany Report #EWC021133117 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 5 MG/DAY Professional Surmontil Company (Trimipramine) C Representative Tegretol Other (Carbamazepine) C Rivotril(Clonazepam) C Meleril(Thioridazine Hydrochloride) C Date:12/18/02ISR Number: 4029243-6Report Type:Expedited (15-DaCompany Report #US_020786227 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphoria Foreign Zyprexa-Oral Insomnia Health (Olanzapine) Irritability Professional (Olanzapine) PS 10 MG/DAY Oedema Peripheral Other Clonazepam C Petechiae Pitting Oedema Date:12/18/02ISR Number: 4029244-8Report Type:Expedited (15-DaCompany Report #US_021089160 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Olanzapine-Oral Phosphokinase Increased Study (Olanzapine) PS Hepatocellular Damage Health Risperdal Hypercholesterolaemia Professional (Risperidone) C Insomnia Other Akineton (Biperiden Restless Legs Syndrome Hydrochloride) C Contomin 24-Jun-2005 12:19 PM Page: 2144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Chlopromazine Hydrochloride) C Benzalin(Nitrazepam) C Date:12/18/02ISR Number: 4029247-3Report Type:Expedited (15-DaCompany Report #DE_021210266 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myalgia Foreign Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Health (Olanzapine) Syndrome Professional (Olanzapine) PS 15 MG/DAY Other Seroxat (Paroxetine Hydrochloride) C Date:12/18/02ISR Number: 4029249-7Report Type:Expedited (15-DaCompany Report #EWC021233275 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS 5 MG/DAY Drugs Other Eclampsia Maternal Drugs Affecting Foetus Pregnancy Date:12/18/02ISR Number: 4029251-5Report Type:Expedited (15-DaCompany Report #AU_021205736 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/IN THE Other EVENING Minipress(Prazosin Hydrochloride) C Temazepam C Ginseng C Date:12/18/02ISR Number: 4029256-4Report Type:Expedited (15-DaCompany Report #USA021224283 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Tardive Dyskinesia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Haldol (Haloperidol) C Date:12/18/02ISR Number: 4029293-XReport Type:Expedited (15-DaCompany Report #US_021190054 Age:35 YR Gender:Female I/FU:F Outcome PT Death Anxiety Completed Suicide Hyperglycaemia Irritability 24-Jun-2005 12:19 PM Page: 2145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obsessive-Compulsive Disorder Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG AT Professional BEDTIME Company Vegetamin A C Representative Other Date:12/18/02ISR Number: 4029295-3Report Type:Expedited (15-DaCompany Report #DE_021110134 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Zyprexa-Oral Initial or Prolonged Hepatocellular Damage Health (Olanzapine) Ultrasound Abdomen Professional (Olanzapine) PS 20 MG DAY Abnormal Other Aquaphor C Urinary Tract Infection Date:12/18/02ISR Number: 4029306-5Report Type:Expedited (15-DaCompany Report #AU_021205731 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Foreign Olanzapine-Oral Initial or Prolonged Supraventricular Health (Olanzapine) PS 10 MG/DAY Extrasystoles Professional Cyproheptadine C Supraventricular Other Pantoprazole C Tachycardia Treatment Noncompliance Ventricular Extrasystoles Date:12/18/02ISR Number: 4029365-XReport Type:Expedited (15-DaCompany Report #US_021290384 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Zyprexa-Oral Hospitalization - Glomerulonephritis Health (Olanzapine) Initial or Prolonged Rapidly Progressive Professional (Olanzapine) PS 10 MG/DAY Haematemesis Company Epadel (Ethyl Pulmonary Haemorrhage Representative Icosapentate) C Other Tasmolin (Biperiden) C Benzalin (Nitrazepam) C Date:12/18/02ISR Number: 4029469-1Report Type:Expedited (15-DaCompany Report #US_000337090 Age:25 YR Gender:Male I/FU:F Outcome PT Death Accidental Overdose Circulatory Collapse Coma Drug Toxicity Excoriation Fibrosis Head Injury Laceration 24-Jun-2005 12:19 PM Page: 2146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Congestion Pulmonary Haemorrhage Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Pulmonary Vascular Literature Zyprexa-Oral Disorder Consumer (Olanzapine) Renal Vessel Disorder Health (Olanzapine) PS Testicular Disorder Professional Benztropine C Thymus Disorder Lorazepam C Clonazepam C Date:12/18/02ISR Number: 4029470-8Report Type:Expedited (15-DaCompany Report #USA021124027 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Chest Pain (Olanzapine) PS 10 MG/DAY Coronary Artery Surgery Effexor (Vanlafaxine Diabetes Mellitus Hydrochloride) C Treatment Noncompliance Neurontin (Gabapentin) C Trazadone (Trazodone) C Date:12/18/02ISR Number: 4029481-2Report Type:Expedited (15-DaCompany Report #US_011278610 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Zyprexa Hospitalization - Asthenia Literature (Olanzapine) PS 20 MG/DAY Initial or Prolonged Clonic Convulsion Health Haloperidol C ORAL Constipation Professional Akineton Disinhibition Company (Biperiden Dizziness Representative Hydrochloride) C Drug Interaction Other Flunitrazepam C Drug Level Above Selbex (Teprenone) C Therapeutic Quetiapine Fumarate C Drug Withdrawal Syndrome Promethazine C Electroencephalogram Pursennid (Senna Abnormal Leaf) C Eye Disorder Ebrantil (Urapidil) C Fall Metligine (Midodrine Loss Of Consciousness Hydrochloride) C Orthostatic Hypotension Halcion (Triazolam) C Urinary Retention Date:12/19/02ISR Number: 4026279-6Report Type:Direct Company Report #CTU 183028 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Zyprexa 5mg Lilly PS Lilly ORAL 5MG DAILY ORAL Lithium Carbonate C 24-Jun-2005 12:19 PM Page: 2147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/02ISR Number: 4030199-0Report Type:Expedited (15-DaCompany Report #FR9375116DEC2002 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Temesta (Lorazepam, Initial or Prolonged Overdose Health Tablet, 0) PS ORAL 170 MG 1X PER Professional 1 DAY 1 DAY Depamide (Valpromide, , 0) SS 1 DAY Effexor (Venlafaxine Hydrochloride, Tablet, 0) SS ORAL 2.37 G 1X PER 1 DAY 1 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 50 MG 1X PER 1 DAY 1 DAY Risperdal (Risperidone, ,0) SS 1 DAY Rivotril (Clonazepam, , 0) SS 1 DAY Theralene (Alimemazine Tartrate, , 0) SS ORAL 30 ML 1X PER 1 DAY 1 DAY Topiramate (Topiramate, , 0) SS 1 DAY Tranxene (Clorazepate Dipotassium, , 0) SS ORAL 500 MG 1X PER 1 DAY 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 140 MG 1X PER 1 DAY 1 DAY Date:12/20/02ISR Number: 4030961-4Report Type:Expedited (15-DaCompany Report #K200202018 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Kemadrin Initial or Prolonged Hypotension Other (Procyclidine) Loss Of Consciousness Tablet, 5 Mg PS Overdose Clozapine Shock (Clozapine) SS Olanzapine (Olanzapine) SS Date:12/23/02ISR Number: 4028539-1Report Type:Direct Company Report #CTU 183234 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Zyprexa PS Eli Lilly ONCE DAILY Delirium Lithium C Hyperglycaemia Weight Increased 24-Jun-2005 12:19 PM Page: 2148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/02ISR Number: 4032346-3Report Type:Expedited (15-DaCompany Report #2002-102213-NL M1315-2002 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Cholestatic Foreign Mirtazapine PS ORAL 15 MG Initial or Prolonged Health Olanzapine SS 5 MG Professional Dothiepin SS ORAL 25 MG Other Ferrous Sulphate C Folic Acid C Sodium Picosulfate C Date:12/24/02ISR Number: 4033450-6Report Type:Expedited (15-DaCompany Report #GBS021011749 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ependymoma Foreign Zyprexa-Oral Spinal Cord Disorder Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/1 DAY Company Representative Date:12/24/02ISR Number: 4033524-XReport Type:Expedited (15-DaCompany Report #US_020987707 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Foreign Olanzapine-Oral Dehydrogenase Increased Health (Olanzapine) PS 10 MG/DAY Drug Eruption Professional Vegetamin A C Erythema Company Depas (Etizolam) C Excoriation Representative Nasopharyngitis Other Photosensitivity Reaction Pruritus Pyrexia Toxic Epidermal Necrolysis White Blood Cell Count Increased Date:12/24/02ISR Number: 4033525-1Report Type:Expedited (15-DaCompany Report #FR_021101660 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acid Base Balance Foreign Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine) Blood Creatine Professional (Olanzapine) PS 5 MG/DAY Phosphokinase Increased Company Prozac (Fluoxetine Blood Lactate Representative Hydrochloride) C Dehydrogenase Increased Other Tercian Body Temperature (Cyamemazine) C Increased Depamide Coma (Valpromide) C Heat Stroke Hyperglycaemia 24-Jun-2005 12:19 PM Page: 2149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/02ISR Number: 4033672-4Report Type:Expedited (15-DaCompany Report #USA021224466 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa-Oral Corrected Interval Professional (Olanzapine) Prolonged Company (Olanzapine) PS Representative Date:12/24/02ISR Number: 4033675-XReport Type:Expedited (15-DaCompany Report #USA021224684 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Death Health Zyprexa-Oral Initial or Prolonged Intentional Misuse Professional (Olanzapine) Medication Error Company (Olanzapine) PS 15 MG/DAY Representative Date:12/24/02ISR Number: 4033676-1Report Type:Expedited (15-DaCompany Report #USA021224761 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Zyprexa-Oral Other Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Vioxx (Rofecoxib) C Date:12/24/02ISR Number: 4033810-3Report Type:Expedited (15-DaCompany Report #USA021224773 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Health Zyprexa-Oral Antidiuretic Hormone Professional (Olanzapine) Secretion (Olanzapine) PS 7.5 MG/DAY Date:12/24/02ISR Number: 4033813-9Report Type:Expedited (15-DaCompany Report #US_021290840 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Literature Olanzapine-Oral Initial or Prolonged Bipolar Disorder Health (Olanzapine) PS 15 MG/DAY Other Blood Pressure Decreased Professional Fluoxetine Csf Glucose Abnormal Hydrochloride-Oral Dysarthria (Fluoxetine) SS 20 MG/DAY 2 WK Nausea Divalproex Sodium C Neuroleptic Malignant Syndrome Date:12/24/02ISR Number: 4033998-4Report Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 2150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Acute Myocardial Foreign Seroquel PS 200 MG TID PO Infarction Health Olanzapine SS Cardiomyopathy Professional Cipramil C Delirium Other Haloperidol C Psychotic Disorder Temazepam C Ventricular Hypokinesia Date:12/24/02ISR Number: 4034268-0Report Type:Expedited (15-DaCompany Report #A01200204067 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Iscover (Clopidogrel Hospitalization - Thrombocytopenia Professional Sulfate) Tablet 75mg PS ORAL 75 MG OD Initial or Prolonged Zyprexa (Olanzapine ) Tablet 10 Mg SS ORAL 10 MG OD Omeprazol Alter (Omeprazole) C Procrin (Leuprorelin Acetate) C Lexatin (Bromazepam) C Zyloric (Allopurinol) C Date:12/24/02ISR Number: 4034283-7Report Type:Expedited (15-DaCompany Report #USA020819396 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Loxapine C Date:12/24/02ISR Number: 4034318-1Report Type:Expedited (15-DaCompany Report #GBS021011749 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ependymoma Foreign Zyprexa-Oral Spinal Cord Disorder Health (Olanzapine)(Olanzap Professional ine) PS 7.5 MG/1 DAY Company Representative Other Date:12/24/02ISR Number: 4034328-4Report Type:Expedited (15-DaCompany Report #DE_021210334 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Company Anafranil Representative (Clomipramine Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/02ISR Number: 4034347-8Report Type:Expedited (15-DaCompany Report #EWC021233344 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Carcinoma Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine)(Olanzap Professional ine) PS 15 MG/DAY Company Piportil Representative (Pipotiazine) C Other Rivotril (Clonazepam) C Date:12/24/02ISR Number: 4034349-1Report Type:Expedited (15-DaCompany Report #GBS021212262 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Cholestatic Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 5 MG/1 AT Professional BEDTIME Other Mirtazapine C Dothiepin C Ferrous Sulphate C Folic Acid C Sodium Picosulphate C Date:12/24/02ISR Number: 4034351-XReport Type:Expedited (15-DaCompany Report #CA_021005459 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anoxic Encephalopathy Foreign Zyprexa-Oral Initial or Prolonged Coma Health (Olanzapine)(Olanzap Condition Aggravated Professional ine) PS 20 MG/AT Electrocardiogram Qt Company BEDTIME Prolonged Representative Rivotril Schizophrenia, Other (Clonazepam) C Disorganised Type Kemadrin (Procyclidine Hydrochloride) C Date:12/24/02ISR Number: 4034353-3Report Type:Expedited (15-DaCompany Report #EWC021233291 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine)(Olanzap Professional ine) PS 15 MG/DAY Company Aurorix Representative (Moclobemide) C Other Seroxat (Paroxetine Hydrochloride) C Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/02ISR Number: 4034355-7Report Type:Expedited (15-DaCompany Report #EWC021233301 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Zyprexa-Oral Hospitalization - Thrombocytopenia Health (Olanzapine)(Olanzap Initial or Prolonged Professional ine) PS 10 MG/DAY Other Omeprazole C Procrin (Leuprorelin Acetate) C Lexatin (Bromazepam) C Zyloric (Allopurinol) C Iscover (Clopidogrel Sulfate) C Date:12/24/02ISR Number: 4034356-9Report Type:Expedited (15-DaCompany Report #US_021088725 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Olanzapine-Oral Initial or Prolonged Asthenia Study (Olanzapine) PS 10 MG/2 DAY Blood Cholesterol Health Contomin Increased Professional (Chlorpromazine Cardiomyopathy Other Hydrochloride) C Constipation Neuleptil Emotional Disorder (Periciazine) C Hepatitis Serenace Insomnia (Haloperidol) C Neoplasm Artane Renal Impairment (Trihexyphenidyl White Blood Cell Count Hydrochloride) C Decreased Vegetamin A C Silece (Flunitrazepam) C Pursennid (Senna Leaf) C Levotomin (Levomepromazine Maleate) C Date:12/24/02ISR Number: 4034358-2Report Type:Expedited (15-DaCompany Report #US_021290869 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Polycythaemia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine)(Olanzap Professional ine) PS Company Representative Other Date:12/24/02ISR Number: 4034364-8Report Type:Expedited (15-DaCompany Report #GBS021212238 Age: Gender: I/FU:I Outcome PT Hospitalization - Circulatory Collapse Initial or Prolonged Hypotension Intentional Misuse 24-Jun-2005 12:19 PM Page: 2153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Clozaril (Clozapine) C Procyclidine C Date:12/24/02ISR Number: 4034368-5Report Type:Expedited (15-DaCompany Report #GBS021212244 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Haloperidol C Procyclidine C Modecate (Fluphenazine Decanoate) C Date:12/24/02ISR Number: 4034372-7Report Type:Expedited (15-DaCompany Report #GBS021212258 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Foreign Olanzapine-Oral Hospitalization - Pulmonary Disease Health (Olanzapine) PS Initial or Prolonged Circulatory Collapse Professional Dothiepin C Pulmonary Oedema Other Piportil Depot Sudden Death (Pipotiazine Palmitate) C Nitrazepam C Procyclidine C Propanolol C Date:12/24/02ISR Number: 4034377-6Report Type:Expedited (15-DaCompany Report #FR_021201762 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Overdose Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Depakote (Valproate Semisodium) C Xanax (Alprazolam) C Effexor (Venlafaxine Hydrochloride) C Date:12/26/02ISR Number: 4030796-2Report Type:Direct Company Report #CTU 183387 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Zyprexa PS ORAL 7.5 MG PO QD Syndrome 24-Jun-2005 12:19 PM Page: 2154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4031697-6Report Type:Periodic Company Report #01-11-0615 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-75MG QD ORAL Zyprexa Tablets SS ORAL ORAL Mellaril Tablets SS ORAL ORAL Cogentin C Date:12/26/02ISR Number: 4035494-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB04140 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Carbamazepine Contusion Health (Carbamazepine)Unkno Epilepsy Professional wn PS Intentional Misuse Other Fluoxetine Toxicologic Test Abnormal (Fluoxetine) SS Zyprexa (Olanzapine) SS ORAL ORAL Date:12/26/02ISR Number: 4038722-7Report Type:Periodic Company Report #US_000847178 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Consumer Humulin-Human Initial or Prolonged Blood Glucose Increased Insulin (Rdna): 30% Pruritus Regular, 70% Nph (H PS 60 U/2 DAY Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Humulin-Human Ultralente Insulin (Rdna) (Human Insu SS 10 U/L DAY Humalog-. (Lispro) SS Zyprexa (Olanzapine) SS 10 MG/L AT BEDTIME Haldol Decanoate (Haloperidol Decanoate) C Klonopin (Clonazepam) C Diphenhydramine C Hydroxyzine C Date:12/26/02ISR Number: 4038887-7Report Type:Periodic Company Report #US_990115366 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Diabetic Ketoacidosis Drug Ineffective Movement Disorder Pancreatic Disorder 24-Jun-2005 12:19 PM Page: 2155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Humalog (Lispro) PS 10 U/3 DAY Health Humulin-Human Professional Regular Insulin (Rdna)(Human Insulin SS 6 U/3 DAY Humulin-Human Nph Insulin (Rdna)(Human Insulin (Rd SS Zyprexa-Oral (Olanzapine)(Olanzap ine) SS 15 MG/DAY Humalog.-Lispro SS Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Lantus (Insulin Glargine) C Risperdal (Risperidone) C Novolin N (Insulin Human Injection, Isophane) C Novolog (Insulin Aspart) C Lithium C Synthroid (Levothyroxine Sodium) C Premarin (Estrogen Conjugated) C Klonopin (Clonazepam) C Date:12/30/02ISR Number: 4032720-5Report Type:Direct Company Report #CTU 183546 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Zyprexa 10mg Lilly PS Lilly ORAL ONCE A DAY FOR 3 YEARS ORAL 3 YR Date:12/30/02ISR Number: 4036551-1Report Type:Expedited (15-DaCompany Report #DE9382123DEC2002 Age:65 YR Gender:Female I/FU:I Outcome PT Hospitalization - Hypotension Initial or Prolonged Intentional Misuse Pallor 24-Jun-2005 12:19 PM Page: 2156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Tavor (Lorazepam, Professional Tablet, 0) PS ORAL 40 TABLETS (OVERDOSE AMOUNT 40MG) ORAL Eunerpan (Melperone Hydrochloride) SS ORAL 10 TABLETS (OVERDOSE AMOUNT 1000MG) ORAL Zoloft (Sertraline Hydrochloride) SS ORAL OVERDOSE AMOUNT 50 TABLETS, ORAL Zopiclone (Zopiclone) SS ORAL 20 TABLETS (OVERDOSE AMOUNT 150MG) ORAL Zyprexa (Olanzapine) SS ORAL 10 TABLETS 2.5MG (OVERDOSE AMOUNT 25MG) ORAL Date:12/31/02ISR Number: 4034170-4Report Type:Periodic Company Report #2000630 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Consumer Keppra PS ORAL 250 MG 2/D PO Erectile Dysfunction Keppra SS ORAL 375 MG 2/D PO Keppra SS ORAL 500 MG 2/D PO Zyprexa SS ORAL 2.5 MG PO Zyprexa SS ORAL 5 MG PO Depakote C Synthyroid C Date:12/31/02ISR Number: 4036658-9Report Type:Expedited (15-DaCompany Report #US_021290969 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Zyprexa-Oral Initial or Prolonged Dialysis (Olanzapine) Other Hallucination (Olanzapine) PS Nasopharyngitis Digoxin C Pneumonia Renal Failure Schizophrenia Date:12/31/02ISR Number: 4036665-6Report Type:Expedited (15-DaCompany Report #US_021290950 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Gastric Ulcer Haemorrhage 24-Jun-2005 12:19 PM Page: 2157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperventilation Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/DAY/ A FEW YEARS Avapro (Irbesartan) C Demadex (Torasemide) C Paxil (Paroxetine Hydrochloride) C Date:12/31/02ISR Number: 4036666-8Report Type:Expedited (15-DaCompany Report #USA021224877 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Infection Health Zyprexa-Oral Hospitalization - Respiratory Arrest Professional (Olanzapine) Initial or Prolonged (Olanzapine) PS 10 MG/DAY Date:12/31/02ISR Number: 4036704-2Report Type:Expedited (15-DaCompany Report #DE_021210354 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Oral Initial or Prolonged Neutrophil Count Health (Olanzapine)(Olanzap Decreased Professional ine) PS 5 MG DAY Pneumonia Other Orfiril (Valproate Sodium) C Melneurin (Melperone Hydrochloride) C Enalapril C Hydrochlorothiazid C Bisoprolol C Digoxin C Ximovan (Zopiclone) C Marcumar (Phenprocoumon) C Date:12/31/02ISR Number: 4036705-4Report Type:Expedited (15-DaCompany Report #DE_021210370 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine)(Olanzap Professional ine) PS 5 MG/1 DAY Other Citalopram C Lorazepam C Date:12/31/02ISR Number: 4036706-6Report Type:Expedited (15-DaCompany Report #EWC021233357 Age:58 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Diabetes Mellitus Insulin-Dependent 24-Jun-2005 12:19 PM Page: 2158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Hypotension Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine)(Olanzap Professional ine) PS 10 MG/DAY Other Clopixol (Zuclopenthixol Decanoate) C Date:12/31/02ISR Number: 4036760-1Report Type:Expedited (15-DaCompany Report #FR_021201796 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Haemorrhage Foreign Zyprexa-Oral Initial or Prolonged Intraductal Papilloma Of Health (Olanzapine) Breast Professional (Olanzapine) PS 20 MG/DAY Other Date:01/06/03ISR Number: 4036986-7Report Type:Direct Company Report #CTU 183934 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Olanzapine PS Date:01/06/03ISR Number: 4036991-0Report Type:Direct Company Report #CTU 183874 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Olanzapine 10mg Lilly PS Lilly ORAL 10MG QHS ORAL Olanzapine 5mg Lilly SS Lilly ORAL 5MG BID ORAL Date:01/07/03ISR Number: 4038078-XReport Type:Direct Company Report #CTU 184002 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Olanzapine PS ORAL 5 MG QHS PO Initial or Prolonged Syndrome Date:01/09/03ISR Number: 4040810-6Report Type:Expedited (15-DaCompany Report #DE_021210397 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hidradenitis Foreign Zyprexa-Oral Consumer (Olanzapine)(Olanzap Other ine) PS 10 MG/DAY Date:01/09/03ISR Number: 4040813-1Report Type:Expedited (15-DaCompany Report #US_021291113 Age:58 YR Gender:Male I/FU:I Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 2159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Foreign Zyprexa-Oral Hypoxic Encephalopathy Health (Olanzapine)(Olanzap Injury Asphyxiation Professional ine) PS 5 MG/DAY Company Bicamol(Biperiden Representative Hydrochloride) C Other Bup-4(Propiverine Hydrochloride) C Eurodin(Estazolam) C Brotizolam C Date:01/09/03ISR Number: 4040822-2Report Type:Expedited (15-DaCompany Report #US_021190285 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Foreign Olanzapine-Oral Life-Threatening Hyponatraemia Study (Olanzapine) PS 20 MG DAY Injury Asphyxiation Health Haloperidol C Vomiting Professional Zotepine C Other Biperiden C Brotizolam C Flunitrazepam C Date:01/10/03ISR Number: 4041175-6Report Type:Expedited (15-DaCompany Report #328513 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Rivotril Initial or Prolonged Tremor Other (Clonazepam) PS ORAL ORAL Valium Diazepam SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Loxapac (Loxapine) SS ORAL ORAL Tranxene (Clorazepate Dipotassium) SS ORAL ORAL Tegretol (Carbamazepine) SS ORAL ORAL Date:01/13/03ISR Number: 4040979-3Report Type:Direct Company Report #CTU 184250 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Trifluoperazine PS 15MG HSBY Depressed Level Of MOUTH Consciousness Olanzapine Tab, Movement Disorder Rapid Disintegr SS ORAL 10MG HSPO Ascorbic Acid C Multivitamin C Vitamin B Complex C Vitamin E C Ranidine Hcl C Heparin Na ,Pork C Acetaminophen C 24-Jun-2005 12:19 PM Page: 2160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/03ISR Number: 4041245-2Report Type:Direct Company Report #CTU 184328 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Zyprexa 10mg PS ORAL 10MG BID ORAL Dizziness Date:01/13/03ISR Number: 4041978-8Report Type:Expedited (15-DaCompany Report #EWC030133475 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Thrombosis Foreign Zyprexa-Oral Deep Vein Thrombosis Health (Olanzapine) Pulmonary Embolism Professional (Olanzapine) PS Other Date:01/13/03ISR Number: 4041980-6Report Type:Expedited (15-DaCompany Report #EWC030133473 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Olanzapine-Oral Initial or Prolonged Cerebral Haemorrhage Consumer (Olanzapine) PS ORAL 5 MG/DAY Coma Other Gliclazide C Zofenopril C Cardirene (Acetylsalicylate Lysine) C Trental (Pentoxifylline) C Date:01/13/03ISR Number: 4041982-XReport Type:Expedited (15-DaCompany Report #030106-PM0017-00 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Tranxene Initial or Prolonged Tremor Health (Clorazepate Professional Dipotassium) PS ORAL P.O. Other Carbamazepine SS ORAL P.O. Clonazepam SS ORAL P.O. Diazepam SS ORAL P.O Loxapine Succinate SS ORAL P.O. Olanzapine SS ORAL P.O. Date:01/13/03ISR Number: 4041984-3Report Type:Expedited (15-DaCompany Report #030109-PM0019-00 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Tranxene Initial or Prolonged Health (Clorazepate Professional Dipotassium) PS ORAL 5 MG, P.O. QD Other Lithium Carbonate SS ORAL 250 MG, P.O. BID Olanzapine SS ORAL 10 MG, P.O. QD Zopiclone SS ORAL 7.5 MG, P.O. QD YR 24-Jun-2005 12:19 PM Page: 2161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/03ISR Number: 4042722-0Report Type:Expedited (15-DaCompany Report #02P-062-0204412-00 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Akineton Retard Initial or Prolonged Health (Biperiden) PS ORAL SEE IMAGE Professional Ziprasidone Hydrochloride SS ORAL SEE IMAGE Olanzapine SS ORAL SEE IMAGE Lorazepam C Date:01/14/03ISR Number: 4043103-6Report Type:Expedited (15-DaCompany Report #2003-102508-NL Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Mirtazapine PS ORAL 5 MG Increased Health Olanzapine SS ORAL 10 MG Arrhythmia Professional Alprazolam SS ORAL 1000 MG Cardiac Arrest Dyspnoea Date:01/15/03ISR Number: 4042987-5Report Type:Expedited (15-DaCompany Report #US_021291111 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Olanzapine-Oral Other Atrioventricular Block Health (Olanzapine) PS 20 MG/DAY First Degree Professional Akineton (Riperiden Cardiac Death Company Hyrochloride) C Cardio-Respiratory Arrest Representative Limas (Lithium Chest Pain Other Carbonate) C Dyskinesia Excitability Date:01/15/03ISR Number: 4043508-3Report Type:Expedited (15-DaCompany Report #GBS030112363 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypomania Foreign Olanzapine-Oral Health (Olanzapine) PS 10 MG Professional Citalopram C Other Carbamazepine C Piportil Depot (Pipotiazine Palmitate) C Orphenadrine C Date:01/15/03ISR Number: 4043517-4Report Type:Expedited (15-DaCompany Report #S03-UKI-00005-01 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Cipralex Increased Health (Escitalopram) PS ORAL 20 MG QD PO Professional Olanzapine SS ORAL 10 MG QD PO Other 24-Jun-2005 12:19 PM Page: 2162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/03ISR Number: 4043521-6Report Type:Expedited (15-DaCompany Report #US_021291107 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Olanzapine-Oral Other Faecal Incontinence Study (Olanzapine) PS 5 MG DAY Fall Health Haloperidol C Gastrointestinal Professional Biperiden C Haemorrhage Other Sulpiride C Haematemesis Alprazolam C Shock Haemorrhagic Levomepromazine C Flunitrazepam C Sennoside A C Vegetamin A C Date:01/15/03ISR Number: 4043522-8Report Type:Expedited (15-DaCompany Report #GBS030112365 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 10 MG/AT Blood Alkaline Professional BEDTIME Phosphatase Increased Other Fluoxetine C Gamma-Glutamyltransferase Procyclidine C Increased Date:01/15/03ISR Number: 4043533-2Report Type:Expedited (15-DaCompany Report #USA021225267 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Transient Consumer Zyprexa-Oral Delusion (Olanzapine) Diarrhoea (Olanzapine) PS 5 MG/DAY Mouth Ulceration Date:01/15/03ISR Number: 4043618-0Report Type:Expedited (15-DaCompany Report #US_030191326 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Prozac-Oral Dizziness Other (Fluoxetine) Grand Mal Convulsion (Fluoxetine Tinnitus Hydrochloride) PS 40 MG Tremor Zyprexa-Oral (Olanzapine) (Olanzapine) SS Xanax (Alprazolam) C Date:01/15/03ISR Number: 4043838-5Report Type:Expedited (15-DaCompany Report #USA-2002-0002680 Age:40 YR Gender:Male I/FU:F Outcome PT Death Cardiomegaly Coronary Artery Atherosclerosis Drug Toxicity Fall Head Injury 24-Jun-2005 12:19 PM Page: 2163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Steatosis Hypertension Laceration Report Source Product Role Manufacturer Route Dose Duration Myocardial Infarction Consumer Oxycodone Overdose Health Hydrochloride Toxicologic Test Abnormal Professional (Similar To Nda Other 20-553)Oxycodone Hydrochloride) PS Morphine Sulfate (Morphine Sulfate) SS Diazepam (Diazepam) SS Acetaminophen (Paracetamol) SS Olanzapine (Olanzapine) SS Date:01/16/03ISR Number: 4042762-1Report Type:Direct Company Report #CTU 184672 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Olanzapine PS ORAL 10 MG BEDTIME ORAL Nefazodone C Gabapentin C Flunisolide C Tretinoin C Sildenafil Citrate C Alprazolam C Lorazepam C Date:01/16/03ISR Number: 4042986-3Report Type:Direct Company Report #CTU 184730 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Zyprexa Zydis PS ORAL 10 MG PO QAM &QHS Lithium Citrate C Klonopin C Benadryl C Thorazine C Haldol C Date:01/17/03ISR Number: 4043765-3Report Type:Direct Company Report #CTU 184782 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cognitive Disorder Zyprexa 10 Mg PS ORAL 10 MG DAILY Required Drug Dependence ORAL Intervention to Myalgia Prevent Permanent Nervous System Disorder Impairment/Damage Pain Panic Disorder With Agoraphobia Tardive Dyskinesia 24-Jun-2005 12:19 PM Page: 2164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4044178-0Report Type:Direct Company Report #CTU 184900 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Celecoxib PS ORAL "PO:" 100MG Intervention to Increased DAILY Prevent Permanent Aspartate Olanzapine SS 10MG DAILY Impairment/Damage Aminotransferase Increased Blood Alkaline Phosphatase Increased Date:01/21/03ISR Number: 4044249-9Report Type:Direct Company Report #CTU 184866 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Zyprexa 7.5mg PS ORAL 7.5MG QHS Initial or Prolonged ORAL Required Lexapro 10mg SS ORAL 10MG QD ORAL Intervention to Prevent Permanent Impairment/Damage Date:01/21/03ISR Number: 4044696-5Report Type:Expedited (15-DaCompany Report #2003-DE-00014GD Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Lithium Carbonate Initial or Prolonged Bipolar Disorder (Lithium Carbonate) PS SEE IMAGE 3 MON Body Temperature Risperidone Increased (Risperidone) SS 3 MG NR Cognitive Disorder Paroxetine Constipation (Paroxetine) SS 20 MG NR Drug Interaction Olanzapine Drug Level Below (Antipsychotics) SS SEE IMAGE Therapeutic Benztropine Dry Mouth (Benzatropine Parkinsonian Crisis Mesilate) SS 2 MG Vision Blurred Nortriptyline (Nortriptyline) SS 50 MG Date:01/21/03ISR Number: 4045855-8Report Type:Expedited (15-DaCompany Report #L02-USA-03743-12 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram Health (Citalopram Professional Hydrobromide) PS Nortriptyline SS Olanzapine SS Date:01/21/03ISR Number: 4045858-3Report Type:Expedited (15-DaCompany Report #B0285914A Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Literature Aspirin (Aspirin) PS ORAL ORAL Health Valproic Acid Professional (Valproic Acid) SS ORAL ORAL 24-Jun-2005 12:19 PM Page: 2165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine (Olanzapine) SS Date:01/22/03ISR Number: 4044549-2Report Type:Direct Company Report #CTU 184990 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Zyprexa PS ORAL 10MG BID ORAL Hospitalization - Consciousness Wellbutrin SS ORAL 150MG BID Initial or Prolonged Neuroleptic Malignant ORAL Syndrome Date:01/23/03ISR Number: 4046161-8Report Type:Expedited (15-DaCompany Report #EWC030133516 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine Health (Olanzapine) PS 15 MG/DAY Professional Valproate Sodium C Other Romparkin (Trihexyphenidyl) C Diazepam C Phenobarbital C Date:01/23/03ISR Number: 4046165-5Report Type:Expedited (15-DaCompany Report #JP_030100314 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affect Lability Foreign Zyprexa-Oral Emotional Disorder Consumer (Olanzapine) Thrombosis Other (Olanzapine) PS 25 MG/DAY Date:01/23/03ISR Number: 4046181-3Report Type:Expedited (15-DaCompany Report #DE_030110492 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fibroadenoma Of Breast Foreign Zyprexa Health (Olanzapine) PS 2.5 MG / DAY Professional Lorazepam C Other Date:01/23/03ISR Number: 4046476-3Report Type:Expedited (15-DaCompany Report #US_020483750 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Hunger Literature (Olanzapine) Other Hyperlipidaemia Health (Olanzapine) PS 15 MG/DAY Laboratory Test Abnormal Professional Risperdal Company (Risperidone) C Representative Akineton (Biperiden Other Hydrochloride) C Lendormin (Brotizolam) C Lipitor (Atorvastatin) C 24-Jun-2005 12:19 PM Page: 2166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bezatol-Slow Release (Bezafibrate) C Date:01/23/03ISR Number: 4046479-9Report Type:Expedited (15-DaCompany Report #FR_021001559 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa-Oral Initial or Prolonged Hallucination Health (Olanzapine) Neuroleptic Malignant Professional (Olanzapine) PS 20 MG/DAY Syndrome Company Tiapridal (Tiapride) C Rhabdomyolysis Representative Shock Other Date:01/23/03ISR Number: 4046496-9Report Type:Expedited (15-DaCompany Report #US_021291107 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Olanzapine-Oral Other Faecal Incontinence Study (Olanzapine) PS 5 MG DAY Gastrointestinal Health Haloperidol C Haemorrhage Professional Biperiden C Haematemesis Other Sulpiride C Shock Haemorrhagic Alprazolam C Levomepromazine C Flunitrazepam C Sennoside A C Vegetamin A C Date:01/23/03ISR Number: 4046544-6Report Type:Expedited (15-DaCompany Report #EWC030133475 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphasia Foreign Zyprexa-Oral Hospitalization - Arterial Thrombosis Health (Olanzapine) Initial or Prolonged Brain Scan Abnormal Professional (Olanzapine) PS 30 MG/DAY Carotid Artery Thrombosis Other (DURATION: A Computerised Tomogram FEW MONTHS) Abnormal Orfiril (Valproate Diplopia Sodium) C Dizziness Selozok (Metoprolol Facial Palsy Succinate) C Headache Atacand (Candesartan Hemiplegia Cilexetil) C Oedema Peripheral Pneumonia Aspiration Prescribed Overdose Productive Cough Pulmonary Embolism Respiratory Arrest Staphylococcal Infection Streptococcal Infection Sudden Death Vena Cava Thrombosis 24-Jun-2005 12:19 PM Page: 2167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046550-1Report Type:Expedited (15-DaCompany Report #US_021290869 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Foreign Zyprexa-Oral Erythema Health (Olanzapine) Increased Appetite Professional (Olanzapine) PS 10 MG/DAY Red Blood Cell Count Company Contomin Increased Representative (Chlorpromazine White Blood Cell Count Other Hydrochloride) C Increased Doral (Quazepam) C Silece (Flunitrazepam) C Date:01/23/03ISR Number: 4046661-0Report Type:Expedited (15-DaCompany Report #USA030125730 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa Professional (Olanzapine) PS ORAL Date:01/23/03ISR Number: 4046663-4Report Type:Expedited (15-DaCompany Report #USA030125705 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG/3 DAY Representative Date:01/23/03ISR Number: 4046664-6Report Type:Expedited (15-DaCompany Report #USA030125445 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Health Zyprexa Hospitalization - Professional (Olanzapine) PS ORAL 5 MG/DAY 1 DAY Initial or Prolonged Company Risperdal Representative (Risperidone) C Date:01/23/03ISR Number: 4046665-8Report Type:Expedited (15-DaCompany Report #USA030125414 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Zyprexa Initial or Prolonged Cellulitis Professional (Olanzapine) PS Company Prolixin Representative (Fluphenazine Hydrochloride) C Isosorbide C Vitamin E C Zocor (Simvastatin) C 24-Jun-2005 12:19 PM Page: 2168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046667-1Report Type:Expedited (15-DaCompany Report #USA030125406 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Health Zyprexa Initial or Prolonged Bone Marrow Depression Professional (Olanzapine) PS ORAL 10 MG/AT Other Company BEDTIME 1 YR Representative Klonopin (Clonazepam) C Zocor (Simvastatin) C Date:01/23/03ISR Number: 4047289-9Report Type:Expedited (15-DaCompany Report #L03-USA-00135-07 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Carbamazepine PS Intentional Misuse Health Olanzapine SS Professional Clonidine SS Additional Substances Nos SS Date:01/24/03ISR Number: 4047534-XReport Type:Expedited (15-DaCompany Report #CA_021205587 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Humulin-Human Initial or Prolonged Pancreatitis Health Regular Insulin Professional (Rdna) (Human Other Insulin PS Olanzapine-Oral (Olanzapine) SS 20 MG/IN THE EVENING Humulin-Human Nph Insulin (Rdna) (Human Insulin (Rd SS Valproic Acid C Date:01/24/03ISR Number: 4047719-2Report Type:Expedited (15-DaCompany Report #EMADSS200300517 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Fall Health (Unspecified) Loss Of Consciousness Professional (Risperidone) PS UNKNOWN SEE IMAGE Metastases To Meninges Deroxat (Paroxetine Pleural Effusion Hydrochloride) SS UNKNOWN 10 MG, DAILY, Rib Fracture UNKNOWN Sarcoma Temesta (Lorazepam) SS UNKNOWN 2 MG, DAILY, Suicide Attempt UNKNOWN Zyprexa (Olanzapine) SS UNKNOWN 10 MG, DAILY, UNKNOWN Date:01/28/03ISR Number: 4049402-6Report Type:Expedited (15-DaCompany Report #USA021022917 Age:39 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Lactate Consumer Zyprexa-Oral Dehydrogenase Increased Health (Olanzapine)(Olanzap Brain Oedema Professional ine) PS 10 MG/DAY 146 DAY Face Oedema Prolixin Decanoate Feeling Abnormal (Fluphenazine Hyperhidrosis Decanoate) C Hypoaesthesia Lithium Carbonate C Irritability Artane Mania (Trihexyphenidyl Oedema Hydrochloride) C Oedema Peripheral Neurontin Palpitations (Gabapentin) C Paranoia Paxil (Paroxetine Pitting Oedema Hydrochloride) C Somnolence Lasix (Furosemide) C Tachycardia Weight Increased Date:01/28/03ISR Number: 4049408-7Report Type:Expedited (15-DaCompany Report #GBS030112463 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Convulsion Foreign Olanzapine-Oral Hypotonia Health (Olanzapine) PS 12.5 MG/1 DAY Sedation Professional Epilim (Valproate Temperature Regulation Other Sodium) C Disorder Date:01/28/03ISR Number: 4049409-9Report Type:Expedited (15-DaCompany Report #USA030125705 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine)(Olanzap Company ine) PS 30 MG/ 3 DAY Representative Date:01/28/03ISR Number: 4049413-0Report Type:Expedited (15-DaCompany Report #DE_030110501 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oral Initial or Prolonged Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 15 MG/DAY Hypokalaemia Other Aquaphor C Beloc Zok C Date:01/28/03ISR Number: 4049415-4Report Type:Expedited (15-DaCompany Report #EWC030133566 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Life-Threatening Deep Vein Thrombosis Foreign Health Professional 24-Jun-2005 12:19 PM Page: 2170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS 25 MG/DAY Haldol (Haloperidol) C Lorazepam C Akineton (Biperiden/Hydrochlo ride) C Date:01/28/03ISR Number: 4049418-XReport Type:Expedited (15-DaCompany Report #US_030191600 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 5 MG/DAY Aspartate Professional Aminotransferase Company Increased Representative Liver Disorder Other Date:01/28/03ISR Number: 4049419-1Report Type:Expedited (15-DaCompany Report #FR_030101882 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Date:01/28/03ISR Number: 4049420-8Report Type:Expedited (15-DaCompany Report #GBS030112417 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Diastolic Foreign Olanzapine-Oral Abnormal Health (Olanzapine) PS 10 MG/DAY Bradycardia Professional Valproate Sodium C Electrocardiogram Other Sertraline C Abnormal Lithium Carbonate C Lactulose C Fybogel (Ispaghula) C Diazepam C Docusate C Date:01/28/03ISR Number: 4049438-5Report Type:Expedited (15-DaCompany Report #GBS030112435 Age:1 DY Gender: I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Caesarean Section Complications Of Maternal Exposure To Therapeutic Drugs Cyanosis Neonatal Maternal Drugs Affecting Foetus 24-Jun-2005 12:19 PM Page: 2171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premature Baby Small For Dates Baby Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Depixol (Flupentixol Other Decanoate) C Sertraline C Dothiepin C Benzodiazepine C Date:01/28/03ISR Number: 4049725-0Report Type:Expedited (15-DaCompany Report #US_030191592 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Consumer Zyprexa-Oral Aspiration (Olanzapine (Olanzapine) PS 2.5 MG/DAY 3 MON Date:01/28/03ISR Number: 4049727-4Report Type:Expedited (15-DaCompany Report #USA030126101 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 3.75 MG DAY Coumadin (Warfarin Sodium) C Date:01/28/03ISR Number: 4049729-8Report Type:Expedited (15-DaCompany Report #USA030126269 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Myeloma Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY 2 YR Representative Xanax (Alprazolam) C Klonopin (Clonazepam) C Date:01/29/03ISR Number: 4050177-5Report Type:Expedited (15-DaCompany Report #USA-2002-0001280 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Oxycontin Tablets 40 Anxiety Health Mg (Oxycodone Condition Aggravated Professional Hydrochloride) Cr Drug Toxicity Other Tablet PS 40 MG Emotional Disorder Oxycontin Tablets 20 Pain Mg (Oxycodone Prescribed Overdose Hydrochloride) Cr Splenomegaly Tablet SS 20 MG Toxicologic Test Abnormal Meperidine Hydrochloride (Pethidine Hydrochloride) SS Propoxyphene 24-Jun-2005 12:19 PM Page: 2172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Dextropropoxyphene) SS Klonopin (Clonazepam) SS Zyprexa (Olanzapine) SS Acetaminophen (Paracetamol) SS Hydrocodone W/Acetaminophen C Alprazolam (Alprazolam) C Trimox (Amoxicillin Trihydrate) C Promethazine W/Codeine "Pharm Basic" (Promethazine Hydrochloride, Codeine Phosphate) C Diazepam (Diazepam) C Roxicet C Trimethoprim-Sulfa (Trimethoprim, Sulfamethoxazole) C Loperamide (Loperamide) C Carisoprodol (Carisoprodol) C Acetaminophen W/Codeine C Ibuprofen C Prozac (Fluoxetine Hydrochloride) C Depo Provera (Medroxyprogesterone Acetate) C Naproxen Sodium (Naproxen Sodium) C Carbamazepine (Carbamazepine) C Ampicillin (Ampicillin) C Date:01/31/03ISR Number: 4050166-0Report Type:Direct Company Report #CTU 185724 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Zyprexa 5mg PS ORAL 5MG HS ORAL Hospitalization - Syndrome Diovan C Initial or Prolonged Claritin C Required Hctz C Intervention to Ambien C Prevent Permanent Impairment/Damage Date:01/31/03ISR Number: 4050208-2Report Type:Direct Company Report #CTU 185755 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Zyprexa 15 Mg PS ORAL 15 MG QD PO 6 YR Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/03ISR Number: 4051154-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE03407 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Trileptal Fmi Initial or Prolonged Balance Disorder Health (Oxcarbazepine) Bradyphrenia Professional Unknown PS ORAL ORAL; 250 Convulsion Other MG/D,ORAL Coordination Abnormal Zyprexa(Olanzapine) SS 7.5 MG/D, SEE Depressed Level Of IMAGE Consciousness Keppra Drug Ineffective (Levetiracetam) C Drug Interaction Orfiril Desitin C Fatigue Bespar C Initial Insomnia Busp C Nasal Congestion Risperdal C Nausea Vitamins C Pollakiuria Folgamma C Sedation Status Epilepticus Date:02/03/03ISR Number: 4050790-5Report Type:Direct Company Report #CTU 185837 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Zyprexa 10mg Lilly PS Lilly ORAL 10MG DAY ORAL Intervention to Weight Increased Zyprexa 7.5mg Lilly SS Lilly ORAL 15MG DAY ORAL Prevent Permanent Glucophage C Impairment/Damage Amaryl C Date:02/03/03ISR Number: 4051383-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR00501 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Tegretol(Carbamazepi Initial or Prolonged Drug Interaction Health ne) Tablet PS ORAL 400 MG BID Drug Level Above Professional ORAL Therapeutic Other Rivotril Tremor (Clonazepam) SS ORAL ORAL Loxapac (Loxapine Succinate) Tablet SS ORAL 25 MG DAY ORAL Zyprexa (Olanzapine) Tablet SS ORAL 2 DF QD ORAL Valium C Atarax (Hydroxyzine Hydrochloride) Tablet C Date:02/03/03ISR Number: 4051483-0Report Type:Expedited (15-DaCompany Report #328513 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Rivotril Initial or Prolonged Drug Interaction Other (Clonazepam) PS ORAL 1 DOSE FORM Drug Toxicity 2 PER DAY Tremor ORAL Zyprexa (Olanzapine) SS ORAL 2 DOSE FORM 1 PER DAY 24-Jun-2005 12:19 PM Page: 2174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Loxapac (Loxapine) SS ORAL 25 MG ORAL Tegretol (Carbamazepine) SS ORAL 400 MG 2 PER DAY ORAL Atarax (Hydroxyzine Hydrochloride) C Valium (Diazepam) C Date:02/03/03ISR Number: 4051555-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000700 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Decreased Activity Foreign Haldol (5 Mg Tablet) Deep Vein Thrombosis Health (Haloperidol) PS ORAL 20 MG, DAILY, Weight Increased Professional ORAL Zyprexa (Olanzapine) SS ORAL 20 MG, ORAL Akineton (Biperiden Hydrochloride) C Lormetazepam (Lormetazepam) C Date:02/04/03ISR Number: 4050994-1Report Type:Direct Company Report #CTU 185890 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Zyprexia 2.5 Lily PS Lily ONE AT Intervention to Syndrome Prevent Permanent Panic Attack Impairment/Damage Date:02/04/03ISR Number: 4051039-XReport Type:Direct Company Report #CTU 185907 Age:39 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 15 Mg Eli Inadequate Control Lilly PS Eli Lilly ORAL 15 MG 1X Diabetes Mellitus DAILY ORAL Non-Insulin-Dependent Date:02/04/03ISR Number: 4052324-8Report Type:Expedited (15-DaCompany Report #2003AP00312 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Ketoacidosis Health PO Prevent Permanent Professional Zyprexa SS ORAL 5 MG DAILY PO Impairment/Damage Other Zyprexa SS ORAL 10 MG DAILY PO Zyprexa SS ORAL 20 MG DAILY PO Zyprexa SS ORAL 15 MG DAILY PO Toledomin C Contomin C 24-Jun-2005 12:19 PM Page: 2175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/03ISR Number: 4052329-7Report Type:Expedited (15-DaCompany Report #USA021224773 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inappropriate Health Zyprexa-Oral Initial or Prolonged Antidiuretic Hormone Professional (Olanzapine) Other Secretion (Olanzapine) PS 7.5 MG/DAY Zoloft (Sertraline Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Date:02/04/03ISR Number: 4052338-8Report Type:Expedited (15-DaCompany Report #USA021224684 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Death Health Zyprexa-Oral Hospitalization - Intentional Misuse Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 15 MG/DAY Representative Date:02/04/03ISR Number: 4052340-6Report Type:Direct Company Report #CTU 185941 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Olanzapine PS 5MG BID Citalopram C Beclomethasone Intranasal Spray C Bisacodyl C Lamotrigine C Saline Nasal Spray C Vitamin E C Date:02/04/03ISR Number: 4052468-0Report Type:Expedited (15-DaCompany Report #FR_030101892 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Foreign Zyprexa-Oral Burning Sensation Consumer (Olanzapine) Constipation Other (Olanzapine) PS Haematochezia Oedema Peripheral Date:02/04/03ISR Number: 4052486-2Report Type:Expedited (15-DaCompany Report #EWC021132966 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Fluoxetine-Oral Initial or Prolonged Fall Consumer (Fluoxetine) Loss Of Consciousness Health (Fluoxetine Professional Hydrochlor PS 60 MG/DAY Other Olanzapine-Oral (Olanzapine) SS 20 MG/DAY Temesta (Lorazepam) C Seroquel (Quetiapine Fumarate) C 24-Jun-2005 12:19 PM Page: 2176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/03ISR Number: 4052493-XReport Type:Expedited (15-DaCompany Report #GBS030112483 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 20 MG/1 DAY Professional Chlorpromazine C Other Date:02/04/03ISR Number: 4052495-3Report Type:Expedited (15-DaCompany Report #FR_030101888 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemodialysis Foreign Zyprexa-Oral Initial or Prolonged Intentional Misuse Health (Olanzapine) Rhabdomyolysis Professional (Olanzapine) PS Suicide Attempt Other Risperdal (Risperidone) C Teralithe (Lithium Carbonate) C Tranxene (Clorazepate Dipotassium) C Nozinan (Levomepromazine) C Date:02/04/03ISR Number: 4052497-7Report Type:Expedited (15-DaCompany Report #FR_030101848 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa-Oral Initial or Prolonged Drug Interaction Health (Olanzapine) Drug Toxicity Professional (Olanzapine) PS 2 DSG Tremor Other FORM/DAY Rivotril (Clonazepam) C Tegretol (Carbamazepine) C Loxapac (Loxapine Succinate) C Valium (Diazepam) C Atarax (Hydroxyzine Hydrochloride) C Date:02/04/03ISR Number: 4052504-1Report Type:Expedited (15-DaCompany Report #DE_021210370 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine)(Olanzap Professional ine) PS 5 MG/1 DAY Other Citalopram C Lorazepam C 24-Jun-2005 12:19 PM Page: 2177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/03ISR Number: 4052505-3Report Type:Expedited (15-DaCompany Report #DE_021110134 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Atherosclerosis Foreign Zyprexa-Oral Initial or Prolonged Asthenia Health (Olanzapine) Blood Amylase Increased Professional (Olanzapine) PS 20 MG/DAY Hepatocellular Damage Other Aquaphor C Urinary Tract Infection Date:02/04/03ISR Number: 4052506-5Report Type:Expedited (15-DaCompany Report #FR_020701220 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Foreign Zyprexa-Oral Pneumonia Aspiration Health (Olanzapine) Somnolence Professional (Olanzapine) PS 30 MG/DAY Company Clopixol Representative (Zuclopenthixol Other Decanoate) C Rivotril (Clonazepam) C Lepticur (Tropatepine Hydrochloride) C Subutex (Buprenorphine Hydrochloride) C Depakote (Valproate Semisodium) C Date:02/04/03ISR Number: 4052543-0Report Type:Expedited (15-DaCompany Report #DE_030110501 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coronary Artery Disease Foreign Zyprexa-Oral Electrocardiogram Qt Health (Olanzapine) Corrected Interval Professional (Olanzapine) PS 15 MG/DAY Prolonged Other Aquaphor (Xipamide) SS 20 MG/DAY Hyperlipidaemia Beloc Zok Hypokalaemia (Metoprolol Ventricular Extrasystoles Succinate) C Weight Increased Kalinor (Potassium Chloride) C Date:02/04/03ISR Number: 4052544-2Report Type:Expedited (15-DaCompany Report #GBS030112417 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Diastolic Foreign Olanzapine-Oral Decreased Health (Olanzapine) PS 10 MG/DAY Bradycardia Professional Valproate Sodium C Electrocardiogram Qt Other Sertraline C Corrected Interval Lithium Carbonate C Prolonged Lactulose C Fybogel (Ispaghula) C Diazepam C Docusate C 24-Jun-2005 12:19 PM Page: 2178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/03ISR Number: 4052545-4Report Type:Expedited (15-DaCompany Report #GBS020510712 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blepharitis Foreign Zyprexa-Oral Initial or Prolonged Cellulitis Orbital Consumer (Olanzapine) Condition Aggravated Health (Olanzapine) PS 10 MG/DAY Diarrhoea Professional Priadel (Lithium Extrapyramidal Disorder Other Carbonate) C Faecal Incontinence Zopiclone C Gastrooesophageal Reflux Temazepam C Disease Hepatitis B Hyperhidrosis Insomnia Malaise Nausea Oedema Peripheral Rectal Tenesmus Salivary Hypersecretion Skin Inflammation Urinary Incontinence Vein Pain Weight Increased Date:02/04/03ISR Number: 4052549-1Report Type:Expedited (15-DaCompany Report #EWC021032541 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extradural Haematoma Foreign Olanzapine-Oral Initial or Prolonged Syncope Study (Olanzapine) PS 10 MG Health Calcium Carbimide C Professional Other Date:02/04/03ISR Number: 4052573-9Report Type:Expedited (15-DaCompany Report #EWC030133475 Age:50 YR Gender:Female I/FU:F Outcome PT Death Aphasia Hospitalization - Arterial Disorder Initial or Prolonged Arterial Thrombosis Carotid Artery Thrombosis Computerised Tomogram Abnormal Diplopia Dizziness Facial Palsy Haemoglobin Abnormal Headache Hemiplegia Oedema Peripheral Pneumonia Aspiration Prescribed Overdose Pulmonary Microemboli Respiratory Arrest Staphylococcal Infection Streptococcal Infection Sudden Death Superior Vena Caval 24-Jun-2005 12:19 PM Page: 2179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Occlusion Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 30 MG/DAY Other (DURATION: A FEW MONTHS) Orfiril (Valproate Sodium) C Selozok (Metoprolol Succinate) C Atacand (Candesartan Cilexetil) C Date:02/04/03ISR Number: 4052577-6Report Type:Expedited (15-DaCompany Report #US_030191855 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Foreign Olanzapine-Oral Pneumonia Study (Olanzapine) PS 10 MG DAY Sepsis Health Amazolon (Amatadine Professional Hydrochloride) C Other Serenace(Haloperidol ) C Sulpiride C Rize (Clotiazepam) C Selbex (Teprenone) C Levotomin (Levomepromazine Maleate) C Triazolam C Bezatol Sr (Bezafibrate) C Sennoside A + B C Cronmolin (Maprotiline Hydrochloride) C Risperdal (Risperidone) C Serenamin (Diazepam) C Madopar C Paxil (Paroxetine Hydrochloride) C Date:02/04/03ISR Number: 4052579-XReport Type:Expedited (15-DaCompany Report #EWC030133641 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Olanzapine-Oral Initial or Prolonged Red Blood Cell Count Health (Olanzapine) PS 7.5 MG/DAY Decreased Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 2180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/03ISR Number: 4052581-8Report Type:Expedited (15-DaCompany Report #EWC030133602 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Gun Shot Wound Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Anafranil (Clomipramine Hydrochloride) C Date:02/04/03ISR Number: 4052584-3Report Type:Expedited (15-DaCompany Report #EWC030133587 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Foreign Olanzapine-Oral Hospitalization - Epilepsy Health (Olanzapine) PS ORAL 10 MG/DAY Initial or Prolonged Fall Professional Risperidone C Loss Of Consciousness Other Paroxetine C Meningioma Lorazepam C Pleural Effusion Rib Fracture Date:02/04/03ISR Number: 4052925-7Report Type:Expedited (15-DaCompany Report #USA030126888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Strattera Initial or Prolonged Drooling Professional (Atomoxetine Dysarthria Company Hydrochloride) PS 18 MG/DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 7.5 MG/DAY Depakote (Valproate Semidsodium) C Concerta (Methylphenidate Hydrochloride) C Date:02/04/03ISR Number: 4053212-3Report Type:Expedited (15-DaCompany Report #USA020921421 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autoimmune Disorder Health Zyprexa-Oral Phlebitis Professional (Olanzapine) (Olanzapine) PS 15 MG/DAY 2 YR Zoloft (Sertraline Hydrochloride) C Date:02/04/03ISR Number: 4053359-1Report Type:Expedited (15-DaCompany Report #USA030126415 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Progressive Multifocal Consumer Zyprexa-Oral Leukoencephalopathy (Olanzapine) (Olanzapine) PS 6 YR 24-Jun-2005 12:19 PM Page: 2181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/03ISR Number: 4053360-8Report Type:Expedited (15-DaCompany Report #USA030126592 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:02/04/03ISR Number: 4053361-XReport Type:Expedited (15-DaCompany Report #USA030126590 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa-Oral Other Coma Professional (Olanzapine) Depressed Level Of Company (Olanzapine) PS 10 MG Consciousness Representative Thorazine(Chlorproma Drug Interaction zine Hydrochloride) C Movement Disorder Neuroleptic Malignant Syndrome Productive Cough Pyrexia Tardive Dyskinesia Tremor Date:02/04/03ISR Number: 4053362-1Report Type:Expedited (15-DaCompany Report #USA030126857 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Zyprexa-Oral Initial or Prolonged Dysphagia Professional (Olanzapine) Muscle Spasms Company (Olanzapine) PS 10 MG/DAY Muscle Tightness Representative Ativan (Lorazepam) C Date:02/05/03ISR Number: 4053845-4Report Type:Expedited (15-DaCompany Report #2003002973 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Atarax Coordination Abnormal Health (Tablet)(Hydroxyzine Dyskinesia Professional Hydrochloride) PS ORAL 300 MG Fatigue (DAILY), ORAL Gait Disturbance Valnoctamide SS ORAL 2 MG (DAILY), Hypersomnia ORAL Self Injurious Behaviour Meprobamate SS ORAL 240 MG (DAILY), ORAL Clonazepam SS ORAL 6 MG (DAILY), ORAL Olanzapine SS ORAL 25 MG (DAILY), ORAL Ibuprofen SS ORAL 400 MG (DAILY), ORAL Alimemazine Tartrate C Paraffin, Liquid C Cyamemazine C All Other Therapeutic Products C 24-Jun-2005 12:19 PM Page: 2182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/03ISR Number: 4053908-3Report Type:Expedited (15-DaCompany Report #030127-PM0023-00 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Tranxene Initial or Prolonged Intentional Misuse Health (Clorazepate Professional Dipotassium) PS ORAL 500 MG, P.O, Other QD Valpromide SS Lorazepam SS ORAL 170 MG, P.O., QD Alimemazine Tartrate SS ORAL 15 MG, P.O., QD Clonazepam SS Risperidone SS Topiramate SS Olanzapine SS 140 MG, QD Trihexyphenidyl Hydrochloride SS 50 MG Venlafaxine Hydrochloride SS Date:02/06/03ISR Number: 4053109-9Report Type:Direct Company Report #CTU 186148 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Zyprexa 5mg 2 Po Q Required Vertigo Hs PS ORAL 2 PO Q HS Intervention to Weight Increased Lasix C Prevent Permanent Synthroid C Impairment/Damage Prilosec C Albuterol Nebs C Singulair C Date:02/07/03ISR Number: 4055120-0Report Type:Expedited (15-DaCompany Report #NSADSS2003005438 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Arrest Health Risperdal Professional (Unspecified)(Risper done) PS 5 MG, DAILY, UNKNOWN Zyprexa (Olanzapine) SS ORAL 5 MG, DAILY, ORAL Date:02/10/03ISR Number: 4055075-9Report Type:Expedited (15-DaCompany Report #2003004062 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Consumer Lithane (Lithium) PS ORAL 250 MG (BID), Initial or Prolonged ORAL Clorazepate Dipotassium SS ORAL 5 MG (DAILY), ORAL Olanzapine SS ORAL 10 MG (DAILY), ORAL Zopiclone SS ORAL 7.5 MG (DAILY), ORAL 24-Jun-2005 12:19 PM Page: 2183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/03ISR Number: 4055826-3Report Type:Direct Company Report #CTU 186472 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Olanzapine PS ORAL 2.5MG PO QD Hospitalization - Oxycodone C Initial or Prolonged Midodrine C Required Risperidone C Intervention to Morphine Sulfate C Prevent Permanent Amoxicillin/Clavulan Impairment/Damage ate C Levothyroxine C Pamidronate C Date:02/11/03ISR Number: 4056266-3Report Type:Expedited (15-DaCompany Report #2002-10-2453 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abortion Other Trilafon Other Bronchitis (Perphenazine) Chest Pain Tablets PS ORAL 2 MG HS ORAL Complications Of Maternal Zyprexa (Olanzapine) Exposure To Therapeutic Tablets SS ORAL ORAL Drugs Trazodone SS 50 MG HS Conversion Disorder Prozac SS 30-10 MG QD Convulsion Caffeine SS Disturbance In Attention Vicodin C Drug Interaction Flexeril C Drug Withdrawal Syndrome Indocin C Dysphagia Multivitamins C Dystonia Ativan 1 Mg Prn C Emotional Disorder Headache Mastitis Maternal Drugs Affecting Foetus Nausea Neuralgia Somatisation Disorder Speech Disorder Tardive Dyskinesia Throat Tightness Vomiting Weight Decreased Date:02/11/03ISR Number: 4056432-7Report Type:Expedited (15-DaCompany Report #US010607 Age:48 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Provigil PS Intentional Misuse Health Tranxene SS Professional Zyprexa SS Date:02/12/03ISR Number: 4057228-2Report Type:Expedited (15-DaCompany Report #030130-PM0024-00 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Intentional Misuse Initial or Prolonged Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 2184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Foreign Tranxene Health (Clorazepate Professional Dipotassium) Tablets PS ORAL 5 MG, P.O QD Other Risperedone Tablets SS ORAL P.O. Olanzapine Tablets SS ORAL P.O. Lithium Carbonate Tablets SS ORAL P.O. Levomepromazine Tablets SS ORAL P.O. Date:02/12/03ISR Number: 4057235-XReport Type:Expedited (15-DaCompany Report #030109-PM0019-01 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Tranxene Initial or Prolonged Health (Clorazepate Professional Dipotassium) PS ORAL 5 MG, P.O. QD YR Other Lithium Carbonate SS ORAL 250 MG, P.O., BID YR Olanzapine SS ORAL 10 MG, P.O., QD Zopiclone SS ORAL 7.5 MG, P.O., QD YR Date:02/12/03ISR Number: 4057668-1Report Type:Periodic Company Report #A0371843A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Paxil (Formulation Initial or Prolonged Overdose Professional Unknown) (Paroxetine Other Hydrochloride) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Date:02/12/03ISR Number: 4058214-9Report Type:Expedited (15-DaCompany Report #DE_030110580 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Health (Olanzapine) Overdose Professional (Olanzapine) PS 400 MG/DAY Suicide Attempt Other Tavor (Lorazepam) C Stilnox (Zolpidem) C Date:02/12/03ISR Number: 4058216-2Report Type:Expedited (15-DaCompany Report #CA_030105679 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Death Drug Level Increased Foreign Prescribed Overdose Health Professional Company 24-Jun-2005 12:19 PM Page: 2185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 30 MG Date:02/12/03ISR Number: 4058223-XReport Type:Expedited (15-DaCompany Report #EWC030133632 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Olanzapine-Oral Leukocytoclastic Health (Olanzapine) PS 15 MG/DAY Vasculitis Professional Combivent C Respiratory Disorder Other Prednison Respiratory Tract (Prednisolone) C Infection Seretide Diskus C Theophylline C Lorazepam C Date:02/12/03ISR Number: 4058262-9Report Type:Expedited (15-DaCompany Report #USA021123657 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Calcium Abnormal Health Zyprexa-Oral Blood Cholesterol Professional (Olanzapine) Increased (Olanzapine) PS ORAL 25 MG/AT Blood Glucose Abnormal BEDTIME Blood Triglycerides Abnormal Electrocardiogram Qt Corrected Interval Prolonged Pco2 Abnormal Date:02/12/03ISR Number: 4058373-8Report Type:Expedited (15-DaCompany Report #USA030126948 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Intentional Self-Injury Professional (Olanzapine) Lower Limb Fracture Company (Olanzapine) PS 20 MG/DAY 2 MON Weight Increased Representative Date:02/12/03ISR Number: 4058674-3Report Type:Expedited (15-DaCompany Report #US_030191406 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Olanzapine-Oral Initial or Prolonged Condition Aggravated Study (Olanzapine) PS ORAL 10 MG DAY Other Delusion Health Linton (Haloperidol) C Hypochondriasis Professional Levotomin Other (Levomepromazine Maleate) C Lexotan(Bromazepam) C Rohypnol (Flunitrazepam) C 24-Jun-2005 12:19 PM Page: 2186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benzalin (Nitrazepam) C Lendormin (Brotizolam) C Tasmolin (Biperiden) C Ferromia (Ferrous Citrate) C Pursennid (Senna Leaf) C Yodel (Senna) C Magnesium Oxide C Date:02/12/03ISR Number: 4058675-5Report Type:Expedited (15-DaCompany Report #FR_021201796 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intraductal Papilloma Of Foreign Zyprexa-Oral Initial or Prolonged Breast Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Xanax (Alprazolam) C Representative Melleril Other (Thioridazine Hydrochloride) C Lepticur (Tropatepine Hydrochloride) C Date:02/12/03ISR Number: 4058676-7Report Type:Expedited (15-DaCompany Report #FR_030101925 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Induced Foreign Zyprexa -Oral Intra-Uterine Death Health (Olanzapine) Maternal Drugs Affecting Professional (Olanzapine) PS Foetus Other Depakine (Valproate Sodium) C Rivotril (Clonazepam) C Date:02/12/03ISR Number: 4058678-0Report Type:Expedited (15-DaCompany Report #FR_030101923 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Induced Foreign Zyprexa Oral Initial or Prolonged Complications Of Maternal Health (Olanzapnie) Exposure To Therapeutic Professional (Olanzapine) PS 5 MG/DAY Drugs Other Depakine (Valproate Intra-Uterine Death Sodium) C Maternal Drugs Affecting Rivotril Foetus (Clonazepam) C Date:02/12/03ISR Number: 4058697-4Report Type:Expedited (15-DaCompany Report #GBS010909478 Age:39 YR Gender:Male I/FU:F Outcome PT Death Bronchitis Coronary Artery 24-Jun-2005 12:19 PM Page: 2187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atherosclerosis Intentional Misuse Pulmonary Congestion Tracheitis Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS Health Lustral (Sertraline Professional Hydrochloride) C Other Date:02/12/03ISR Number: 4058698-6Report Type:Expedited (15-DaCompany Report #US_030191855 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Foreign Olanzapine-Oral Pneumonia Study (Olanzapine) PS 10 MG DAY Sepsis Health Amazolon (Amantadine Professional Hydrochloride) C Other Serenace (Haloperidol) C Sulpiride C Rize (Clotiazepam) C Selbex (Teprenone) C Levotomin (Levomepromazine Maleate) C Triazolam C Bezatol Sr (Bezafibrate) C Sennoside A+B C Cronmolin (Maprotiline Hydrochloride) C Risperdal (Risperidone) C Serenamin (Diazepam) C Madopar C Paxil (Paroxetine Hydrochloride) C Date:02/12/03ISR Number: 4058712-8Report Type:Expedited (15-DaCompany Report #US_030191945 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Olanzapine Initial or Prolonged Depression Literature (Olanzapine) PS 10 MG/DAY Galactorrhoea Health Paranoia Professional Other Date:02/12/03ISR Number: 4058713-XReport Type:Expedited (15-DaCompany Report #US_030191994 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foreign Body Aspiration Foreign Olanzapine Initial or Prolonged Study (Olanzapine) PS 22.5 MG DAY Other Gramalil (Tiapride Hydrochloride) C Seroquel 24-Jun-2005 12:19 PM Page: 2188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine Fumarate) C Lullan (Lullan) C Eurodin (Estazolam) C Rohypnol (Flunitrazepam) C Alosenn C Pursennid (Senna Leaf) C Nivadil (Nilvadipine) C Magnesium Oxide C Gascon (Dimeticone) C Stomachics & Digestives C Chinese Medicine C Date:02/12/03ISR Number: 4058720-7Report Type:Expedited (15-DaCompany Report #EWC030133566 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Foreign Olanzapine-Oral Weight Increased Health (Olanzapine) PS 25 MG/DAY Professional Haldol (Haloperidol) C Other Lorazepam C Akineton (Biperiden Hydrochloride) C Date:02/12/03ISR Number: 4058724-4Report Type:Expedited (15-DaCompany Report #FR_030101930 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antepartum Haemorrhage Foreign Zyprexa-Oral Initial or Prolonged Caesarean Section Health (Olazapine) Complications Of Maternal Professional (Olanzapine) PS 5 MG/DAY Exposure To Therapeutic Other Drugs Pre-Eclampsia Premature Baby Date:02/12/03ISR Number: 4058725-6Report Type:Expedited (15-DaCompany Report #DE_030110614 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oral Initial or Prolonged Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 5 MG/DAY Electrocardiogram Qt Company Acetylsalicyclic Prolonged Representative Acid C Hypokalaemia Other Cipramil (Citalopram Hydrobromide) C Osyrol (Spironolactone) C Diastabol (Miglitol) C 24-Jun-2005 12:19 PM Page: 2189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/03ISR Number: 4058783-9Report Type:Expedited (15-DaCompany Report #JP_030100350 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Zyprexa-Oral Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS 20 MG/DAY Dialysis Company Serenace Hepatic Failure Representative (Haloperidol) C Neuroleptic Malignant Other Lodopin (Zotepine) C Syndrome Seroquel (Quetiapine Renal Failure Acute Fumarate) C Rhabdomyolysis Valerin (Valproate White Blood Cell Count Sodium) C Increased Wypax (Lorazepam) C Akineton (Biperiden Hydrochloride) C Gasmotin (Mosapride Citrate) C Lac B (Lactobacillus Bifidus, Lyophilized) C Rohypnol (Flunitrazepam) C Vegetamin A C Anatensol (Fluphenazine Hydrochloride) C Levotomin (Levomepromazine Maleate) C Hiberna (Promethazine Hydrochloride) C Date:02/12/03ISR Number: 4058784-0Report Type:Expedited (15-DaCompany Report #GBS030112496 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Olanzapine-Oral Hospitalization - Pulse Absent Health (Olanzapine) PS 2.5 MG Initial or Prolonged Professional Other Date:02/12/03ISR Number: 4058785-2Report Type:Expedited (15-DaCompany Report #FR_030101931 Age:0 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS Drugs Other Haematoma Maternal Drugs Affecting Foetus Placental Disorder Pre-Eclampsia Premature Baby 24-Jun-2005 12:19 PM Page: 2190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/03ISR Number: 4057531-6Report Type:Expedited (15-DaCompany Report #2003AP00312 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Diabetic Ketoacidosis Health PO Prevent Permanent Nasopharyngitis Professional Zyprexa SS ORAL 5 MG DAILY PO Impairment/Damage Weight Increased Other Zyprexa SS ORAL 10 MG DAILY PO Zyprexa SS ORAL 20 MG DAILY PO Zyprexa SS ORAL 15 MG DAILY PO Toledomin C Contomin C Date:02/19/03ISR Number: 4059065-1Report Type:Expedited (15-DaCompany Report #2003002973 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyskinesia Foreign Atarax (Tablet) Fatigue Health (Hydroxyzine Somnolence Professional Hydrochloride) PS ORAL 300 MG (DAILY), ORAL Valnoctamide SS ORAL 2 MG (DAILY), ORAL Meprobamate SS ORAL 240 MG (DAILY), ORAL Clonazepam SS ORAL 6 MG (DAILY), ORAL Olanzapine SS ORAL 25 MG (DAILY), ORAL Ibuprofen SS ORAL 400 MG (DAILY), ORAL Alimemazine Tartrate C Paraffin, Liquid C Cyamemazine C All Other Therapeutic Products C Date:02/19/03ISR Number: 4060448-4Report Type:Expedited (15-DaCompany Report #NSADSS2003005795 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Risperidone Initial or Prolonged Drug Level Increased Health (Unspecified)(Risper Hepatic Encephalopathy Professional idone) PS Ziprasidone SS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Zoloft (Sertraline Hydrochloride) C Gabitril (Tiagabine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Artane 24-Jun-2005 12:19 PM Page: 2191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Trihexyphenidyl Hydrochloride) C Date:02/19/03ISR Number: 4060717-8Report Type:Expedited (15-DaCompany Report #USA-2002-0001280 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Oxycontin Tablets 40 Anxiety Health Mg(Oxycodone Condition Aggravated Professional Hydrochloride) Cr Emotional Disorder Other Tablet PS ORAL 40 MG, BID, Pain ORAL Splenomegaly Oxycontin Tablets 20 Therapeutic Agent Mg(Oxycodone Toxicity Hydrochloride) Cr Toxicologic Test Abnormal Tablet SS 20 MG 14 DAY Meperidine Hydrochloried (Pethidine Hydrochloriede) SS 14 DAY Propoxyphene (Dextropropoxyphene) SS 14 DAY Klonopin (Clonazepam) SS 1 MG, TID; SEE IMAGE Zyprexa (Olanzapine) SS ORAL 10 MG, NOCTE, ORAL Acetaminophen(Parace tamol) SS 14 DAY Hydrocodone W/Acetaminophen C Alprazolam (Alprazolam) C Trimox (Amoxicillin Trihydrate) C Promethazine W/Codeine (Promethazine Hydrochloride) C "Pharm Basic" Diazepam (Diazepam) C Roxicet C Trimetoprim-Sulfa (Trimethoprim, Sulfamethoxazole) C Loperamide(Loperamid e) C Carisoprodol (Carisoprodol) C Acetaminophen W/ Codeine C Ibuprofen C Prozac (Fluoxetine Hydrochloride) C Depo Provera (Medroxyprogesterone Acetate) C Naproxen Sodium (Naproxen Sodium) C Carbamezepine(Carbam azepine) C Ampicillin 24-Jun-2005 12:19 PM Page: 2192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Ampicillin) C Soma C Date:02/20/03ISR Number: 4057314-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185682 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Mucomyst PS Apothecon ORAL 7 DAY Initial or Prolonged Pyrexia Zyprexa SS ORAL 7 DAY Rash Maculo-Papular Artane C Rash Pustular Meprobamate C Skin Exfoliation Date:02/20/03ISR Number: 4058536-1Report Type:Direct Company Report #CTU 186953 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heat Stroke Olanzapine 2.5mg Initial or Prolonged Eli Lilly PS Eli Lilly OCCLUSIVE DRESSING 2.5MG QHS OCCLUSIVE DRESS Benzatropine 1 Mg SS ORAL 1 MG QD ORAL Date:02/20/03ISR Number: 4060918-9Report Type:Expedited (15-DaCompany Report #FR9375116DEC2002 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Temesta (Lorazepam, Initial or Prolonged Overdose Professional Tablet, 0) PS ORAL 170 MG 1X PER Other Other 1 DAY; ORAL 1 DAY Depamide (Valpromide, ,0) SS UNKNOWN UNKNOWN 1 DAY Effexor (Venlafaxine Hydrochloride, Tablet, O) SS ORAL 2.37 G 1X PER 1 DAY; ORAL 1 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 50 MG 1X PER 1 DAY; ORAL 1 DAY Risperdal (Risperidone, , 0) SS UNKNOWN UNKNOWN 1 DAY Rivotril (Clonazepam, , 0) SS UNKNOWN UNKNOWN 1 DAY Theralene (Alimemazine Tartrate, , 0) SS ORAL 30 ML 1X PER 1 DAY; ORAL 1 DAY Topiramate (Topiramate, , 0) SS UNKNOWN UNKNOWN 1 DAY Tranxene (Clorazepate Dipotassium, , 0) SS ORAL 500 MG 1X PER 1 DAY; ORAL 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 140 MG 1X PER 24-Jun-2005 12:19 PM Page: 2193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY; ORAL 1 DAY Date:02/20/03ISR Number: 4061931-8Report Type:Expedited (15-DaCompany Report #2003AP00312 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Diabetic Ketoacidosis Health PO Prevent Permanent Dry Mouth Professional Zyprexa SS ORAL 5 MG DAILY PO Impairment/Damage Nasopharyngitis Other Zyprexa SS ORAL 10 MG DAILY PO Zyprexa SS ORAL 20 MG DAILY PO Zyprexa SS ORAL 15 MG DAILY PO Toledomin C Contomin C Date:02/24/03ISR Number: 4061450-9Report Type:Periodic Company Report #PHEH2002US09728 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Exelon Professional (Rivastigimine) Company Capsule PS ORAL 1.5 MG, BID, Representative ORAL Zyprexa (Olanzapine) SS SEE IMAGE Glyburide C Klor-Con C Clindamycin (Clindamycin) C Date:02/24/03ISR Number: 4061455-8Report Type:Periodic Company Report #PHEH2002US10365 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Exelon Professional (Rivastigimine) Capsule PS ORAL 3 MG, BID, ORAL Zyprexa (Olanzapine) SS 61 DAY Warfarin Sodium (Warfarin Sodium) C Norvasc C Aciphex (Rabeprazole Sodium) C Xanax (Alprazolam) C Zoloft (Sertraline Hydrochloride) C Date:02/24/03ISR Number: 4064760-4Report Type:Expedited (15-DaCompany Report #USA030126888 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Strattera Initial or Prolonged Drooling Professional (Atomoxetine Dysarthria Company Hydrochloride) PS 18 MG/DAY Representative Zyprexa-Oral 24-Jun-2005 12:19 PM Page: 2194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS 7.5 MG/DAY Depakote(Valproate Semisodium) C Concerta (Methylphenidate Hydrochloride) C Date:02/24/03ISR Number: 4064867-1Report Type:Expedited (15-DaCompany Report #NSADSS2003007614 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anencephaly Health Topamax (Topiramate) PS URETHRAL UTERINE Maternal Drugs Affecting Professional Zyprexia Foetus (Olanzapine) SS Pregnancy Date:02/24/03ISR Number: 4065026-9Report Type:Expedited (15-DaCompany Report #USA030228363 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apallic Syndrome Consumer Zyprexa-Oral Neuroleptic Malignant Company (Olanzapine) Syndrome Representative (Olanzapine) PS Celexa(Citalopram Hydrobromide) C Date:02/25/03ISR Number: 4061307-3Report Type:Direct Company Report #CTU 187305 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Zyprexa 15mg Lilly PS Lilly ZYPREXA 15MG Pulmonary Embolism DAILY 1 YR Artane 5mg SS ARTANE 5MG 1 YR Allegra SS Date:02/25/03ISR Number: 4065119-6Report Type:Expedited (15-DaCompany Report #EWC021233243 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Zyprexa-Oral Initial or Prolonged Incontinence Health (Olanzapine) Influenza Professional (Olanzapine) PS 15 MG/DAY Neuroleptic Malignant Company Quilonorm Retard Syndrome Representative (Lithium Carbonate) C Overdose Other Akineton(Biperiden Hydrochloride) C Date:02/25/03ISR Number: 4065122-6Report Type:Expedited (15-DaCompany Report #EWC030233815 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Kyphosis Foreign Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS 15 MG/AT BEDTIME Nozinan (Levomepromazine) C 24-Jun-2005 12:19 PM Page: 2195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamictal (Lamotrigine) C Orfinil (Valproate Sodium) C Selo-Zok (Metoprolol Succinate) C Vallergan (Alimemazine Tartrate) C Haldol (Haloperidol) C Largactil (Chlorpromazine Hydrochloride) C Date:02/25/03ISR Number: 4065124-XReport Type:Expedited (15-DaCompany Report #EWC030233762 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Foreign Olanzapine-Oral Abnormal Health (Olanzapine) PS ORAL 7.5 MG/DAY Electrocardiogram Qt Professional Haldol (Haloperidol) C Prolonged Company Akineton (Biperiden Medication Error Representative Hydrochloride) C Sinus Bradycardia Other Date:02/25/03ISR Number: 4065127-5Report Type:Expedited (15-DaCompany Report #GBS030212553 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Foreign Olanzapine-Oral Circulatory Collapse Other (Olanzapine) PS Death Citalopram C Toxicologic Test Abnormal Date:02/25/03ISR Number: 4065129-9Report Type:Expedited (15-DaCompany Report #GBS030112500 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Olanzapine-Oral Exposure To Therapeutic Health (Olanzapine) PS 15 MG Drugs Professional Dothiepin C Postpartum Haemorrhage Other Sulpiride C Prolonged Labour Date:02/25/03ISR Number: 4065198-6Report Type:Expedited (15-DaCompany Report #US_030191613 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Olanzapine-Oral Initial or Prolonged Fall Health (Olanzapine) PS 10 MG/DAY Other Loss Of Consciousness Professional Depas (Etizolam) C Muscle Rigidity Company Lendormin Nuclear Magnetic Representative (Brotizolam) C Resonance Imaging Other Hirnamin Abnormal (Levomepromazine) C Polydipsia Vomiting 24-Jun-2005 12:19 PM Page: 2196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/03ISR Number: 4065200-1Report Type:Expedited (15-DaCompany Report #US_021290784 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa-Oral Hospitalization - Coma Literature (Olanzapine) Initial or Prolonged Dialysis Health (Olanzapine) PS 125 MG/DAY Electroencephalogram Professional Tegretol Abnormal Company (Carbamazepine) C Flatulence Representative Amoxan (Amoxapine) C Heart Rate Increased Other Ubretid (Distigmine Intentional Misuse Bromide) C Mydriasis Tryptanol Suicide Attempt (Amitriptyline Hydrochloride) C Melex (Mexazolam) C Date:02/25/03ISR Number: 4065218-9Report Type:Expedited (15-DaCompany Report #US_030191600 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olnazapine-Oral Increased Health (Olanzapine) PS 5 MG/DAY Aspartate Professional Aminotransferase Company Increased Representative Blood Cholinesterase Other Decreased Hepatic Function Abnormal Date:02/25/03ISR Number: 4065220-7Report Type:Expedited (15-DaCompany Report #US_021189528 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Zyprexa-Oral Other Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS 10 MG/DAY Hepatic Function Abnormal Company Halosten Hypothermia Representative (Haloperidol) C Other Serenace (Haloperidol) C Pyrethia (Promethazine Hydrocloride) C Hirnamin (Levomepromazine) C Sepazon (Cloxazolam) C Akineton (Biperiden Hydrochloride) C Toughmac E C Vegetamin A C Pursennid (Senna Leaf) C 24-Jun-2005 12:19 PM Page: 2197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/03ISR Number: 4065396-1Report Type:Expedited (15-DaCompany Report #DE_021009810 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Dispersible Initial or Prolonged Corrected Interval Health (Olanzapine) PS 20 MG/IN THE Prolonged Professional EVENING Company Representative Other Date:02/25/03ISR Number: 4065402-4Report Type:Expedited (15-DaCompany Report #GBS021111983 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Foreign Zyprexa-Oral Initial or Prolonged Coma Health (Olanzapine) PS 700 MG/DAY Hypotension Professional Effexor (Venlafaxine Intentional Misuse Other Hydrochloride) C Respiratory Disorder Date:02/25/03ISR Number: 4065884-8Report Type:Expedited (15-DaCompany Report #USA030228559 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Maternal Drugs Affecting Health Zyprexa-Oral Initial or Prolonged Foetus Professional (Olanzapine) Neonatal Apnoeic Attack (Olanzapine) PS Date:02/25/03ISR Number: 4065885-XReport Type:Expedited (15-DaCompany Report #US_030292429 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Literature Olanzapine-Oral Initial or Prolonged Cellulitis Health (Olanzapine) PS 10 MG/DAY 8 MON Hyperreflexia Professional Kefzol (Cefazolin Laceration Sodium) SS Major Depression Paroxetine C Neuroleptic Malignant Lamotrigine C Syndrome Lorazepam C Oliguria Nifedipine C Suicide Attempt Lisinopril C White Blood Cells Urine Furosemide C Positive Fluvastatin C Tamsulosin Hydrochloride C Sorbitol C Aspirin C Docusate Sodium C Date:02/25/03ISR Number: 4065887-3Report Type:Expedited (15-DaCompany Report #USA030228646 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anencephaly Health Zyprexa-Oral Congenital Anomaly Professional (Olanzapine) Maternal Drugs Affecting (Olanzapine) PS Foetus Topamax (Topiramate) C 24-Jun-2005 12:19 PM Page: 2198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/03ISR Number: 4065888-5Report Type:Expedited (15-DaCompany Report #USA030228398 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Zyprexa-Oral Hospitalization - Drug Interaction Professional Olanzapine) PS 5 MG/DAY Initial or Prolonged Hypotension Company Clonidine C Other Representative Beta Blocker C Date:02/25/03ISR Number: 4065902-7Report Type:Expedited (15-DaCompany Report #JP_030200370 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Hirnamin Representative (Levomepromazine) C Other Date:02/25/03ISR Number: 4065916-7Report Type:Expedited (15-DaCompany Report #US_030292496 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Olanzapine-Oral Initial or Prolonged Hepatic Function Abnormal Study (Olanzapine) PS 10 MG/DAY Parkinsonism Health Akineton (Biperiden Professional Hydrochloride) C Other Rohypnol (Fluntrazepam) C Selbex (Teprenone) C Date:02/25/03ISR Number: 4065917-9Report Type:Expedited (15-DaCompany Report #FR_030202011 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zyprexa-Oral Initial or Prolonged Speech Disorder Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Temesta (Lorazepam) C Date:02/25/03ISR Number: 4065918-0Report Type:Expedited (15-DaCompany Report #GBS030212574 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis A Foreign Olanzapine-Oral Restless Legs Syndrome Health (Olanzapine) PS 2.5 MG/DAY Professional Dothiepin C Other Date:02/25/03ISR Number: 4065919-2Report Type:Expedited (15-DaCompany Report #GBS030212580 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Other Stevens-Johnson Syndrome Foreign Health Professional 24-Jun-2005 12:19 PM Page: 2199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Carbamazepine C Lustral (Sertraline Hydrochloride) C Date:02/25/03ISR Number: 4065920-9Report Type:Expedited (15-DaCompany Report #FR_030201998 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Foreign Zyprexa-Oral Initial or Prolonged Pyrexia Health (Olanzapine) Rash Maculo-Papular Professional (Olanzapine) PS 10 MG/DAY Rash Pustular Other Mucomyst Skin Exfoliation (Acetylcusteine) C Toxic Skin Eruption Artane (Trihexyphenidyl Hydrochloride) C Meprobamate C Date:02/25/03ISR Number: 4065935-0Report Type:Expedited (15-DaCompany Report #USA030228432 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Company Strattera Complex Partial Seizures Representative (Atomoxetine Mania Hydrochloride) PS 40 MG/DAY Weight Increased Zyprexa-Oral (Olanzapine) (Olanzapine) SS 13.75 MG/DAY Ativan (Lorazepam) C Axid (Nizatidine) C Flonase (Fluticasone Propionate) C Neurontin (Gabapentin) C Topamax (Topiramate) C Date:02/25/03ISR Number: 4066160-XReport Type:Expedited (15-DaCompany Report #US_000948999 Age:53 YR Gender:Male I/FU:F Outcome PT Death Blood Bicarbonate Decreased Blood Chloride Increased Blood Creatinine Increased Blood Ketone Body Present Blood Potassium Increased Blood Sodium Increased Blood Urea Increased Circadian Rhythm Sleep Disorder Coronary Artery 24-Jun-2005 12:19 PM Page: 2200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atherosclerosis Diabetes Mellitus Diabetic Ketoacidosis Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Hepatic Steatosis Study Zyprexa-Oral Hypersomnia Literature (Olanzapine) Rib Fracture Health (Olanzapine) PS 2 DSG Professional FORM/DAY Other Date:02/25/03ISR Number: 4066492-5Report Type:Expedited (15-DaCompany Report #USA030127460 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Drug Level Above Professional (Olanzapine) Therapeutic (Olanzapine) PS 20 MG DAY Haematemesis Pancrease Intentional Misuse (Pancrelipase) C Date:02/25/03ISR Number: 4066493-7Report Type:Expedited (15-DaCompany Report #USA021123627 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Stress Professional (Olanazapine) Company (Olanizapine) PS 20 MG/DAY Representative Paxil (Paroxetine Hydrochloride) C Date:02/25/03ISR Number: 4066528-1Report Type:Expedited (15-DaCompany Report #DE_030210690 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa-Oral Initial or Prolonged Blood Cholesterol Health (Olanzapine) Increased Professional (Olanzapine) PS 10 MG/DAY Blood Triglycerides Other Remergil Increased (Mirtazapine) C Rhabdomyolysis Benzodiazepine C Date:02/25/03ISR Number: 4066529-3Report Type:Expedited (15-DaCompany Report #FR_030202020 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bulimia Nervosa Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS 10 MG/DAY Hypersomnia Company Depakote (Valproate Weight Increased Representative Semisodium) C Other 24-Jun-2005 12:19 PM Page: 2201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/03ISR Number: 4066530-XReport Type:Expedited (15-DaCompany Report #EWC030233892 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Respiratory Arrest Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Delorazepam C Representative Other Date:02/25/03ISR Number: 4066531-1Report Type:Expedited (15-DaCompany Report #EWC030133728 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Olanzapine-Oral Initial or Prolonged Depressed Level Of Health (Olanzapine) PS 5 MG Other Consciousness Professional Thioridazine C Drug Withdrawal Syndrome Other Amitriptyline C Neuroleptic Malignant Syndrome Pneumonia Aspiration Date:02/25/03ISR Number: 4066532-3Report Type:Expedited (15-DaCompany Report #EWC030233821 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa-Oral Goitre Health (Olanzapine) Prothrombin Time Professional (Olanzapine) PS 5 MG/DAY Shortened Other Dobupal (Venlafaxine Therapeutic Response Hydrochloride) C Decreased Sintrom(Acenocoumaro Thyroxine Abnormal l) C Seguril C Enalapril C Date:02/25/03ISR Number: 4066609-2Report Type:Expedited (15-DaCompany Report #CA_030105679 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Zyprexa-Oral Hospitalization - Therapeutic Consumer (Olanzapine) Initial or Prolonged Drug Level Increased Health (Olanzapine) PS 30 MG Other Feeling Cold Professional Zyprexa-Oral Prescribed Overdose Company (Olanzapine) Somnolence Representative (Olanzapine) SS 20 MG/DAY Therapeutic Agent Other Toxicity Vomiting Date:02/26/03ISR Number: 4066629-8Report Type:Expedited (15-DaCompany Report #2003004062 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Consumer Lithane (Lithium) PS ORAL 250 MG (BID), Initial or Prolonged Health ORAL Professional Clorazepate 24-Jun-2005 12:19 PM Page: 2202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dipotassium SS ORAL 5 MG (DAILY), ORAL Olanzapine SS ORAL 10 MG (DAILY), ORAL Zopiclone SS ORAL 7.5 MG (DAILY), ORAL Date:02/26/03ISR Number: 4066877-7Report Type:Expedited (15-DaCompany Report #030130-PM0024-01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Tranxene Initial or Prolonged Rhabdomyolysis Health (Clorazepate Suicide Attempt Professional Dipotassium) Tablets PS ORAL 5 MG, P.O. QD Other Risperedone Tablets SS ORAL P.O. Olanzapine Tablets SS ORAL P.O. Lithium Carbonate Tablets SS ORAL P.O. Levomepromazine Tablets SS ORAL P.O. Date:02/27/03ISR Number: 4067068-6Report Type:Expedited (15-DaCompany Report #GBS030112483 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 20 MG/1 DAY Professional Chlorpromazine C Other Date:02/27/03ISR Number: 4067312-5Report Type:Expedited (15-DaCompany Report #DE_021210354 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa -Oral Initial or Prolonged Drug Hypersensitivity Health (Olanzapine ) Lobar Pneumonia Professional (Olanzapine) PS 5 MG DAY Other Orfiril (Valporate Sodium) C Melneurin(Melperone Hydrochloride) C Enlapril C Hydrochlorothiazid C Bisoprolol C Digoxin C Ximovan(Zopiclone) C Marcumar (Phenprocoumon) C Date:02/27/03ISR Number: 4067314-9Report Type:Expedited (15-DaCompany Report #DE_030110580 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Health (Olanzapine) Overdose Professional (Olanzapine) PS 400 MG/DAY Suicide Attempt Other Tavor (Lorazepam) C Stilnox (Zolpidem) C 24-Jun-2005 12:19 PM Page: 2203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/03ISR Number: 4067316-2Report Type:Expedited (15-DaCompany Report #DE_021110078 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Incompetence Foreign Zyprexa-Oral Initial or Prolonged Aortic Valve Stenosis Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS 15 MG/DAY Ischaemic Cardiomyopathy Other Tiapridex (Tiapride Myocardial Infarction Hydrochloride) C Pneumonia Bronchoretard Pulmonary Oedema (Theophylline) C Rhabdomyolysis Norvasc (Amlodipine Right Ventricular Failure Besilate) C Arelix (Piretanide) C Delix (Ramipril) C Aldactone (Spironolactone) C Cefpodoxime C Date:02/27/03ISR Number: 4067318-6Report Type:Expedited (15-DaCompany Report #FR_021201796 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intraductal Papilloma Of Foreign Zyprexa-Oral Initial or Prolonged Breast Health (Olanzapine)(Olanzap Professional ine) PS 20 MG/DAY Company Xanax(Alprazolam) C Representative Melleril Other (Thioridazine Hydrochloride) C Lepticur (Tropatepine Hydrochloride) C Date:02/27/03ISR Number: 4067479-9Report Type:Expedited (15-DaCompany Report #DE_030110614 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Foreign Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine) Electrocardiogram Qt Professional (Olanzapine) PS 5 MG/DAY Corrected Interval Company Acetylsalicylic Acid C Prolonged Representative Cipramil (Citalopram Electrocardiogram Qt Other Hydrobromide) C Prolonged Osyrol Hypokalaemia (Spironolactone) C Diastabol(Miglitol) C Kalinor (Potassium Chloride) C Date:02/27/03ISR Number: 4067549-5Report Type:Expedited (15-DaCompany Report #EWC021032567 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Foreign Olanzapine-Oral Initial or Prolonged Leukaemia Health (Olanzapine) PS 10 MG/DAY Other Professional Other 24-Jun-2005 12:19 PM Page: 2204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/03ISR Number: 4068580-6Report Type:Expedited (15-DaCompany Report #EWC030133641 Age:15 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Olanzapine-Oral Red Blood Cell Count Health (Olanzapine) PS 7.5 MG/DAY Decreased Professional Company Representative Other Date:02/28/03ISR Number: 4068187-0Report Type:Expedited (15-DaCompany Report #03P-062-0211080-00 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Akineton (Biperiden) Initial or Prolonged Respiratory Failure Health (Biperiden) PS ORAL 2 MG, 19 IN 1 Salivary Hypersecretion Professional ONCE, PER Suicide Attempt ORAL Chlorazepam SS ORAL 5 MG, 3 IN 1 ONCE, PER ORAL Sertraline Hydrochloride SS ORAL 50 MG, 10 IN 1 ONCE, PER ORAL Clozapine SS ORAL 100 MG, 40 IN 1 ONCE, PER ORAL Parstelin SS ORAL 16 TABLET, 1 IN 1 ONCE, PER ORAL Diazepam SS ORAL 10 MG, 15 IN 1 ONCE, PER ORAL Prothipendyl Hydrochloride SS ORAL 80 MG, 20 IN 1 ONCE, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 ONCE, PER ORAL Date:03/03/03ISR Number: 4066123-4Report Type:Direct Company Report #CTU 187796 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Zyprexia 0.25 Mg/Day Discomfort Eli Lilly/Total Care Pharmaceutical Product Pharmacy PS Eli Lilly/Total Care Complaint Pharmacy ORAL 0.25 MG/DAY Weight Decreased PILL ORAL Date:03/03/03ISR Number: 4069724-2Report Type:Expedited (15-DaCompany Report #2003002621 Age:39 YR Gender: I/FU:I Outcome PT Report Source Death Completed Suicide Literature Health 24-Jun-2005 12:19 PM Page: 2205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Sinequan (Cap) (Doxepin) PS Olanzapine SS Paroxetine SS Date:03/03/03ISR Number: 4069824-7Report Type:Expedited (15-DaCompany Report #2003003832 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anion Gap Increased Health Lithium (Lithium) PS ORAL 600 MG(BID), Initial or Prolonged Anxiety Professional ORAL Blood Alkaline Olanzapine SS ORAL 20 MG, ORAL Phosphatase Increased Atenolol C Blood Bicarbonate Lorazepam C Decreased Blood Glucose Increased Blood Thyroid Stimulating Hormone Increased Depression Dysarthria Gait Disturbance Haematocrit Decreased Lymphocyte Count Decreased Neutrophil Count Increased Platelet Disorder Red Blood Cell Count Decreased Renal Failure Acute Schizophrenia Therapeutic Agent Toxicity Date:03/04/03ISR Number: 4065482-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0293775A Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Lithium Carbonate PS Glaxosmithkline Initial or Prolonged Rhabdomyolysis Professional Tranxene SS ORAL 5MG Four Suicide Attempt times per day Risperidone SS ORAL Olanzapine SS Levomepromazine SS Date:03/04/03ISR Number: 4066221-5Report Type:Direct Company Report #USP 55556 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Pfizer Zyprexa SS Lilly 24-Jun-2005 12:19 PM Page: 2206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/03ISR Number: 4069386-4Report Type:Expedited (15-DaCompany Report #USA030229256 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Health Zyprexa-Oral Rhabdomyolysis Professional (Olanzapine) (Olanzapine) PS Date:03/04/03ISR Number: 4069390-6Report Type:Expedited (15-DaCompany Report #USA030228745 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged (Olanzapine) PS Date:03/04/03ISR Number: 4069393-1Report Type:Expedited (15-DaCompany Report #USA030228817 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplegia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY 1 DAY Representative Haldol C Date:03/04/03ISR Number: 4069881-8Report Type:Expedited (15-DaCompany Report #USA030228664 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Pain Consumer Zyprexa-Oral Confusional State Company (Olanzapine) Feeling Abnormal Representative (Olanzapine) PS 10 MG Feeling Jittery Hallucination Hyperhidrosis Insomnia Memory Impairment Tremor Vaginal Haemorrhage Date:03/04/03ISR Number: 4069886-7Report Type:Expedited (15-DaCompany Report #USA030229330 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Strattera Deficit/Hyperactivity Professional (Atomoxetine Disorder Company Hydrochloride) PS 40 MG/DAY Mania Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 12.5 MG/DAY Effexor-Xr (Venlafaxine Hydrochloride) C Wellbutrin Sr (Bupropion Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/03ISR Number: 4070301-8Report Type:Expedited (15-DaCompany Report #US_030292711 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa-Oral Initial or Prolonged Akathisia Literature (Olanzapine) Other Anxiety Health (Olanzapine) PS 20 MG/DAY Emotional Disorder Professional Sulpiride C Excitability Other Eye Disorder Fatigue Fear Irritability Persecutory Delusion Date:03/04/03ISR Number: 4070306-7Report Type:Expedited (15-DaCompany Report #JP_030200410 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Company Luvox (Fluvoxamine Increased Representative Maleate) C Blood Lactate Other Depas (Etizolam) C Dehydrogenase Increased Date:03/04/03ISR Number: 4070307-9Report Type:Expedited (15-DaCompany Report #GBS030212619 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Foreign Zyprexa -Oral Initial or Prolonged Hyponatraemia Health (Olanzapine) Renal Failure Professional (Olanzapine) PS Other Chemotheapy C Date:03/04/03ISR Number: 4070309-2Report Type:Expedited (15-DaCompany Report #EWC030233923 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa-Oral Initial or Prolonged Hallucination Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Remeron Representative (Mirtazapine) C Other Date:03/04/03ISR Number: 4070421-8Report Type:Expedited (15-DaCompany Report #US_030191613 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Olanzapine-Oral Initial or Prolonged Fall Consumer (Olanzapine) PS 10 MG/DAY Other Loss Of Consciousness Health Depas (Etizolam) C Polydipsia Professional Lendormin Vomiting Company (Brotizolam) C Representative Hirnamin Other (Levomepromazine) C 24-Jun-2005 12:19 PM Page: 2208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/03ISR Number: 4070422-XReport Type:Expedited (15-DaCompany Report #GBS030212553 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Olanzapine-Oral Other Death Health (Olanzapine) PS Emphysema Professional Citalopram C Toxicologic Test Abnormal Other Date:03/04/03ISR Number: 4070591-1Report Type:Expedited (15-DaCompany Report #US_011178209 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa-Oral Hospitalization - Blood Triglycerides Literature (Olanzapine) Initial or Prolonged Increased Health (Olanzapine) PS 15 MG/DAY Other Cardio-Respiratory Arrest Professional Timiperone C Condition Aggravated Company Biperiden C Diabetic Hyperosmolar Representative Sepazon(Cloxazolam) C Coma Other Lipantil(Fenofibrate Diabetic Ketoacidosis ) C Fall Seroquel C Hepatocellular Damage Serenace(Haloperidol Hyperlipidaemia ) C Increased Appetite Impromen(Bromperidol Vomiting ) C Date:03/04/03ISR Number: 4070592-3Report Type:Expedited (15-DaCompany Report #US_030292496 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Olanzapine-Oral Initial or Prolonged Hepatic Function Abnormal Study (Olanzapine) PS 10 MG/DAY Parkinsonism Health Akineton (Biperiden Professional Hydrochloride) C Other Rohypnol (Flunitrazepam) C Selbex (Teprenone) C Date:03/05/03ISR Number: 4072173-4Report Type:Periodic Company Report #2003005856 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Bupropion Other Company Hydrochloride SS Representative Olanzapine SS All Other Non-Therapeutic Products SS Date:03/06/03ISR Number: 4068849-5Report Type:Direct Company Report #CTU 188027 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menstruation Irregular Zyprexa 5mg PS ORAL 5MG HS ORAL 24-Jun-2005 12:19 PM Page: 2209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/03ISR Number: 4072062-5Report Type:Expedited (15-DaCompany Report #2003008811 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Consumer Lithane (Lithium) PS ORAL 250 MG (BID), Initial or Prolonged ORAL Zopiclone SS ORAL 7.5 MG (QD), ORAL Clorazepate Dipotassium SS ORAL 5 MG (QD), ORAL Olanzapine SS ORAL 10 MG (QD), ORAL Date:03/10/03ISR Number: 4070275-XReport Type:Direct Company Report #CTU 188310 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Olanzapine PS Throat Tightness Date:03/11/03ISR Number: 4072645-2Report Type:Direct Company Report #CTU 188437 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa 10mg Lilly PS Lilly ORAL 10MG QD PO Required Divalproex Sodium C Intervention to Lithium C Prevent Permanent Impairment/Damage Date:03/12/03ISR Number: 4072000-5Report Type:Direct Company Report #CTU 188574 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Risperdone 0.25 Mg PS ORAL 0.25 MG QHS Initial or Prolonged Consciousness ORAL Fall Olanzapine 2.5 Mg SS ORAL 2.5 MG QHS Medication Error ORAL Miacalcin Spray C Vitamin E C Date:03/12/03ISR Number: 4072387-3Report Type:Direct Company Report #USP 55586 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa (Olanzapine) PS Lilly Celexa (Citalopram Hydrobromide) SS Forest Pharm Date:03/12/03ISR Number: 4073255-3Report Type:Direct Company Report #CTU 188578 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Olanzapine PS ORAL 5 MG DAILY Hospitalization - ORAL Initial or Prolonged Carbamazepine Xr C 24-Jun-2005 12:19 PM Page: 2210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamotrigine C Lorazepam C Date:03/12/03ISR Number: 4075034-XReport Type:Expedited (15-DaCompany Report #USA021124210 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Humulin-Human Obsessive Thoughts Insulin (Rdna): 30% Osteoarthritis Regular, 70% Nph PS Suicidal Ideation Zyprexa-Oral Tremor (Olanzapine) Weight Increased (Olanzapine) SS 15 MG/DAY Levoxyl (Levothyroxine Sodium) C Accupril (Quinapril Hydrochloride) C Vioxx (Rofecoxib) C Avandia (Rosiglitazone Maleate) C Metformin C Lithium C Lorazepam C Diazepam C Aspirin C Atenolol C Date:03/12/03ISR Number: 4075044-2Report Type:Expedited (15-DaCompany Report #USA030228648 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Gemzar (Gemcitabine Other Distress Syndrome Professional Hydrochloride) PS Agitation Company Zyprexa-Oral Pneumonitis Representative (Olanzapine) Psychotic Disorder (Olanzapine) SS Date:03/12/03ISR Number: 4075084-3Report Type:Expedited (15-DaCompany Report #JP_030100328 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Zyprexa-Oral Activities Of Daily Study (Olanzapine) Living Impaired Health (Olanzapine) PS 10 MG/DAY Dementia Professional Orap (Pimozide) C Disorientation Company Artane Dysphagia Representative (Trihexyphenidyl Eye Rolling Other Hydrochloride) C Restlessness Lexotan (Bromazepam) C Metligine (Midodrine Hydrochloride) C Cabagin-U Tab. (Vitamin U) C 24-Jun-2005 12:19 PM Page: 2211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/03ISR Number: 4075160-5Report Type:Expedited (15-DaCompany Report #EWC030233970 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Food Poisoning Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG/DAY Professional Diazepam C Other Date:03/12/03ISR Number: 4075163-0Report Type:Expedited (15-DaCompany Report #EWC030234018 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Foreign Zyprexa-Oral Hospitalization - Blood Glucose Increased Health (Olanzapine) Initial or Prolonged Hypotension Professional (Olanzapine) PS Loss Of Consciousness Other Polydipsia Polyuria Respiratory Arrest Weight Increased Date:03/12/03ISR Number: 4075167-8Report Type:Expedited (15-DaCompany Report #JP_030200376 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Blood Creatine Foreign Zyprexa-Oral Other Phosphokinase Increased Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS 2.5 MG/DAY Rhabdomyolysis Company Contomin Representative (Chlorpromazine Other Hydrochloride) C Flumezin (Fluphenazine) C Tasmolin (Biperiden) C Voltaren (Diclofenac Sodium) C Pursennid (Senna Leaf) C Serenace (Haloperidol) C Date:03/12/03ISR Number: 4075267-2Report Type:Expedited (15-DaCompany Report #GBS030212619 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Foreign Zyprexa-Oral Initial or Prolonged Depression Health (Olanzapine) Extrapyramidal Disorder Professional (Olanzapine) PS 10 MG/DAY Hepatic Cirrhosis Other Chemotherapy C Hepatic Failure Frusemide C Hyponatraemia Quetiapine C Renal Failure 24-Jun-2005 12:19 PM Page: 2212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/03ISR Number: 4075410-5Report Type:Expedited (15-DaCompany Report #USA030229244 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menorrhagia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:03/12/03ISR Number: 4075411-7Report Type:Expedited (15-DaCompany Report #USA030126917 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Other Aspartate Company (Olanzapine) PS 10 MG/DAY Aminotransferase Representative Bactrium Ds C Increased Erythromycin C Blood Alkaline Phosphatase Increased Jaundice Date:03/12/03ISR Number: 4075412-9Report Type:Expedited (15-DaCompany Report #US_030393033 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Disorder Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Date:03/12/03ISR Number: 4075414-2Report Type:Expedited (15-DaCompany Report #USA030229727 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Consumer Prozac-Oral Initial or Prolonged Blood Pressure Increased (Fluoxetine) Disease Recurrence (Fluoxetine Dizziness Hydrochloride) PS 30 MG/IN THE Feeling Abnormal EVENING Heart Rate Increased Zyprexa-Oral Tremor (Olanzapine) (Olanzapine) SS 7.5 MG/IN THE EVENING Date:03/12/03ISR Number: 4075591-3Report Type:Expedited (15-DaCompany Report #USA030230020 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/03ISR Number: 4075593-7Report Type:Expedited (15-DaCompany Report #USA030229399 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Diabetic Neuropathy (Olanzapine) Mania (Olanzapine) PS 35 MG/DAY Effexor (Venlafaxine Hydrochloride) C Date:03/13/03ISR Number: 4073565-XReport Type:Direct Company Report #CTU 188667 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Seroquel 100mg Po Intervention to Pneumonia Tid PS ORAL 100MG PO TID Prevent Permanent Zyprexa 5mg Po Bid SS 5MG BID Impairment/Damage Zantac C Vancomycin C Flovent C Date:03/14/03ISR Number: 4074372-4Report Type:Direct Company Report #CTU 188749 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Lorazepam PS SEE ITEM B5 Cardiac Arrest Zyprexa Zydis SS 10MG TID Drug Interaction Topamax C Physical Assault Prevacid C Respiratory Arrest Klonopin C Peri-Colace C Date:03/17/03ISR Number: 4077566-7Report Type:Expedited (15-DaCompany Report #EMADSS2003000517 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Fall Health (Unspecified) Required Loss Of Consciousness Professional (Risperidone) PS 1 MG; 9 MG, Intervention to Meningeal Neoplasm DAILY Prevent Permanent Pleural Effusion Deroxat (Paroxetine Impairment/Damage Rib Fracture Hydrochloride) SS 10 MG, DAILY, Sarcoma Zyprexa (Olanzapine) SS 10 MG, DAILY Suicide Attempt Temesta (Lorazepam) SS 2 MG, DAILY Date:03/18/03ISR Number: 4075546-9Report Type:Direct Company Report #CTU 188982 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Olanzapine PS ORAL 25 MG PO QHS Intervention to Prolonged Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 2214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/03ISR Number: 4077937-9Report Type:Expedited (15-DaCompany Report #USA021022302 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Consumer Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Confusional State Professional (Olanzapine) PS 15 MG/DAY Constipation Company Lithium C Diabetic Coma Representative Effexor-Xr Hyperglycaemia (Venlafaxine Incontinence Hydrochloride) C Renal Failure Acute Rhabdomyolysis Date:03/18/03ISR Number: 4077939-2Report Type:Expedited (15-DaCompany Report #USA021123457 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Decreased Health Zyprexa-Oral Pulmonary Embolism Professional (Olanzapine) Thrombocythaemia (Olanzapine) PS 5 MGDAY Interferon C Ribavirin C Methadone C Date:03/18/03ISR Number: 4077944-6Report Type:Expedited (15-DaCompany Report #US_020887506 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Consumer Zyprexa-Oral Initial or Prolonged Palpitations Health (Olanzapine) Renal Failure Acute Professional (Olanzapine) PS 15 MG/DAY Rhabdomyolysis Neurontin (Gabapentin) C Dilaudid (Hydromorphone Hydrochloride) C Nicotine Dermal Patch (Nicotine Resin) C Trazodone C Date:03/18/03ISR Number: 4077945-8Report Type:Expedited (15-DaCompany Report #USA030127460 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Haematemesis Professional (Olanzapine) Therapeutic Agent (Olanzapine) PS 20 MG DAY Toxicity Pancrease (Pancrelipase) C Date:03/18/03ISR Number: 4077994-XReport Type:Expedited (15-DaCompany Report #US_030393166 Age: Gender:Male I/FU:I Outcome PT Report Source Death Medication Error Health Professional 24-Jun-2005 12:19 PM Page: 2215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/18/03ISR Number: 4077995-1Report Type:Expedited (15-DaCompany Report #USA030330325 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/DAY Lithium C Date:03/18/03ISR Number: 4077997-5Report Type:Expedited (15-DaCompany Report #US_010870797 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Zyprexa (Olanzapine) PS 205 MG/DAY Initial or Prolonged Agitation Health Paroxetine C Other Blood Pressure Diastolic Professional Adderall C Decreased Company Depressed Level Of Representative Consciousness Heart Rate Increased Intentional Misuse Miosis Mydriasis Pupillary Reflex Impaired Respiratory Rate Increased Somnolence Speech Disorder Date:03/18/03ISR Number: 4078000-3Report Type:Expedited (15-DaCompany Report #USA030230066 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Haemorrhage Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 7.5 MG/DAY Representative Date:03/18/03ISR Number: 4078189-6Report Type:Expedited (15-DaCompany Report #PHBS2003GR02285 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Exelon Initial or Prolonged Difficulty In Walking Health (Rivastigmine) PS ORAL 6 MG/D, ORAL Rhabdomyolysis Professional Zyprexa (Olanzapine) SS 5 MG/DAY Other Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/03ISR Number: 4078193-8Report Type:Expedited (15-DaCompany Report #US_020684963 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Zyprexa-Oral Hospitalization - Bone Marrow Depression Health (Olanzapine) Initial or Prolonged Leukopenia Professional (Olanzapine) PS 10 MG/DAY Other Renal Cyst Company Levotomin(Levomeprom Representative azine Maleate) C Other Rivotril (Clonazepam) C Metoclol (Metoclopramide) C Wypax (Lorazepam) C Lendormin(Brotizolam ) C Rohypnol (Flunitrazepam) C Date:03/18/03ISR Number: 4078195-1Report Type:Expedited (15-DaCompany Report #GBS030212580 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Other Carbamazepine C Lustral (Sertraline Hydrochloride C Date:03/18/03ISR Number: 4078197-5Report Type:Expedited (15-DaCompany Report #GBS030212553 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Foreign Olanzapine- Oral Atherosclerosis Other (Olanzapine) PS Coronary Artery Citalopram C Atherosclerosis Drug Level Above Therapeutic Hepatic Steatosis Myocardial Fibrosis Overdose Pleural Adhesion Pulmonary Alveolar Haemorrhage Pulmonary Congestion Sudden Death Ventricular Hypertrophy Date:03/18/03ISR Number: 4078246-4Report Type:Expedited (15-DaCompany Report #DE_030310821 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Bone Marrow Depression Foreign Initial or Prolonged Convulsion Health Drug Interaction Professional General Physical Health Company Deterioration Representative 24-Jun-2005 12:19 PM Page: 2217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Zoloft (Sertraline Hydrochloride) C Ergenyl (Valproate Sodium) C Sortis (Atorvastatin Calcium) C Beloc Zok (Metoprolol Succinate) C Aponal (Doxepin Hydrochloride) C Date:03/18/03ISR Number: 4078248-8Report Type:Expedited (15-DaCompany Report #GBS030312696 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Zyprexa-Oral Bronchitis Health (Olanzapine)(Olanzap Condition Aggravated Professional ine) PS 10 MG Emphysema Other Reboxetine C Salbutamol C Lithium C Date:03/18/03ISR Number: 4078254-3Report Type:Expedited (15-DaCompany Report #FR_030202093 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Seropram (Citalopram Hydrobromide) C Tercian Icyamemazine) C Date:03/18/03ISR Number: 4078260-9Report Type:Expedited (15-DaCompany Report #GBS030312722 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Olanzapine-Oral Pulmonary Embolism Health (Olanzapine) PS 10 MG Sudden Death Professional Aspirin C Other Ferrous Sulphate C Date:03/18/03ISR Number: 4078262-2Report Type:Expedited (15-DaCompany Report #EWC030334077 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Epistaxis Foreign Extrapyramidal Disorder Health Headache Professional 24-Jun-2005 12:19 PM Page: 2218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS 2.5 MG/DAY Date:03/18/03ISR Number: 4078266-XReport Type:Expedited (15-DaCompany Report #FR_030101930 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Foreign Zyprexa - Oral Initial or Prolonged Caesarean Section Health (Olanzapine) Complications Of Maternal Professional (Olanzapine) PS 5 MG/DAY Exposure To Therapeutic Other Drugs Gastrooesophageal Reflux Disease Maternal Drugs Affecting Foetus Pre-Eclampsia Premature Baby Date:03/18/03ISR Number: 4078272-5Report Type:Expedited (15-DaCompany Report #FR_030101931 Age:0 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS Drugs Other Lamictal Gastrooesophageal Reflux (Lamotrigine) SS Disease Deroxat (Paroxetine Maternal Drugs Affecting Hydrochloride) C Foetus Effexor (Venlafaxine Pre-Eclampsia Hydrochloride) C Premature Baby Date:03/18/03ISR Number: 4078278-6Report Type:Expedited (15-DaCompany Report #JP_030200410 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Company Depas (Etizolam) C Increased Representative Hirnamin Blood Lactate Other (Levomepromazine) C Dehydrogenase Increased Nitrazepam C Liver Disorder Rohypnol (Flunitrazepam) C Date:03/18/03ISR Number: 4078282-8Report Type:Expedited (15-DaCompany Report #JP_030100350 Age:27 YR Gender:Male I/FU:F Outcome PT Life-Threatening Aggression Blood Glucose Fluctuation 24-Jun-2005 12:19 PM Page: 2219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressed Level Of Consciousness Dialysis Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Foreign Zyprexa-Oral Hepatic Failure Health (Olanzapine) Ileus Paralytic Professional (Olanzapine) PS 20 MG/DAY Mydriasis Company Serenace Neuroleptic Malignant Representative (Haloperidol) C Syndrome Other Lodopin (Zotepine) C Pupillary Reflex Impaired Seroquel (Quetiapine Renal Failure Acute Fumarate) C Rhabdomyolysis Valerin (Valproate Salivary Hypersecretion Sodium) C White Blood Cell Count Wypax (Lorazepam) C Increased Akineton (Biperiden Hydrochloride) C Gasmotin (Mosapride Citrate) C Lac B (Lactobacillys Bifidus, Lyophilized) C Rohypnol (Flunitrazepam) C Vegetamine A C Anatensol (Fluphenazine Hydrochloride) C Levotomin (Levomepromazine Maleate) C Hiberna (Promethazine Hydrochloride) C Date:03/18/03ISR Number: 4078285-3Report Type:Expedited (15-DaCompany Report #FR_030101925 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Induced Foreign Zyprexa-Oral Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS Drugs Other Depakine (Valproate Haematoma Sodium) C Intra-Uterine Death Rivotril Maternal Drugs Affecting (Clonazepam) C Foetus Placental Disorder Pregnancy Date:03/18/03ISR Number: 4078287-7Report Type:Expedited (15-DaCompany Report #FR_030101923 Age:34 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abortion Induced Initial or Prolonged Complications Of Maternal Exposure To Therapeutic Drugs Haematoma Intra-Uterine Death 24-Jun-2005 12:19 PM Page: 2220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Placental Disorder Pregnancy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Depakine (Valproate Sodium) C Rivotril (Clonazepam) C Date:03/18/03ISR Number: 4078289-0Report Type:Expedited (15-DaCompany Report #EWC030234018 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Blood Creatinine Abnormal Professional (Olanzapine) PS Blood Pressure Decreased Other Blood Sodium Decreased Blood Urea Increased Diabetes Mellitus Diabetic Ketoacidosis General Physical Health Deterioration Loss Of Consciousness Pco2 Decreased Po2 Increased Respiratory Arrest Weight Increased Date:03/18/03ISR Number: 4078406-2Report Type:Expedited (15-DaCompany Report #JP_030300456 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Foreign Zyprexa Ear Haemorrhage Health (Olanzapine) PS ORAL 5 MG/DAY Fall Professional Depromel Laceration Company (Fluvoxamine) C Loss Of Consciousness Representative Meilax (Ethyl Other Loflazepate) C Date:03/19/03ISR Number: 4077291-2Report Type:Direct Company Report #CTU 189146 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa 10 Mg Qhs PS 10 MG QHS Cyproheptadire C Effexor Xr C Ibuprofen C Acetaminophen C Pilocarpine C Timoptic C Maalox C 24-Jun-2005 12:19 PM Page: 2221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/03ISR Number: 4077475-3Report Type:Direct Company Report #USP 55612 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa Xydis (Olanzapine) PS Lilly Zyprexa (Olanzapine) SS Lilly Date:03/19/03ISR Number: 4077501-1Report Type:Direct Company Report #USP 55607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa (Olanzapine) PS Lilly Zyrtec (Cetirizine Hydrochloride) SS Pfizer Date:03/19/03ISR Number: 4078637-1Report Type:Expedited (15-DaCompany Report #HQWYE011312MAR03 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Dobupal Retard Initial or Prolonged Prothrombin Level Professional (Venlafaxine Decreased Other Hydrochloride, Capsule, Extended Release) PS ORAL 150 MG 2X PER 1 DAY ORAL Sintrom (Acenocoumarol) SS ORAL 7 MG 1X PER 1 DAY ORAL 75 DAY Sintrom (Acenocoumarol) SS ORAL 30 MG 1X PER 1 DAY ORAL Zyprexa (Olanzapine) SS ORAL 5 MG 1X PER 1 DAY ORAL Seguril (Furosemide) C Enalapril (Enalapril) C Date:03/20/03ISR Number: 4074983-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12209664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Paraplatin PS Bristol-Myers Squibb Initial or Prolonged Drug Interaction Company INTRAVENOUS Paranoia Dexamethasone C post Psychotic Disorder chemotherapy 3 DAY Ondansetron C post chemotherapy 3 DAY Olanzapine I administered after cycle 1 of chemotherapy 24-Jun-2005 12:19 PM Page: 2222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/03ISR Number: 4080147-2Report Type:Expedited (15-DaCompany Report #EMADSS2003000517 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) PS 1 MG; 9 MG, Required Loss Of Consciousness Professional DAILY Intervention to Medication Error Deroxat (Paroxetine Prevent Permanent Meningioma Hydrochloride) SS 10 MG, DAILY Impairment/Damage Pleural Effusion Zyprexa (Olanzapine) SS 10 MG, DAILY Rib Fracture Temesta (Lorazepam) SS 2 MG, DAILY Suicidal Ideation Date:03/20/03ISR Number: 4080646-3Report Type:Expedited (15-DaCompany Report #L02-USA-03743-12 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Celexa (Citalopram Convulsion Health Hydrobromide) PS Depressed Level Of Professional Nortriptyline SS Consciousness Olanzapine SS Ventricular Fibrillation Ventricular Tachycardia Date:03/21/03ISR Number: 4078235-XReport Type:Direct Company Report #CTU 189237 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Zyprexa 10 Mg PS ORAL 10 MG PO HS Intervention to Megace 800 Mg SS ORAL 800 MG PO QAM Prevent Permanent Impairment/Damage Date:03/24/03ISR Number: 4076710-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0294907A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tremor Deroxat PS Glaxosmithkline ORAL 20MG Per day 56 DAY Initial or Prolonged Lithium Sulphate SS ORAL 330MG Per day 12 DAY Zyprexa SS ORAL 5MG Per day 50 DAY Temesta C ORAL 3MG Per day Date:03/24/03ISR Number: 4079668-8Report Type:Direct Company Report #CTU 189323 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Zyprexa 5mg @Hs PS ORAL HS PO Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 2223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/03ISR Number: 4082854-4Report Type:Expedited (15-DaCompany Report #2002-01825 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Foreign Loxitane Im Initial or Prolonged Health (Loxapac)(Loxapine Professional Hydrochloride) Company Injection, 50 Mg/Ml PS INTRAMUSCULAR 150 MG, Representative SINGLE, Other INTRAMUSCULAR Nozinan(Levomepromaz ine) SS ORAL 100 GTT, SINGLE, ORAL Risperidal(Risperido ne) Tablet SS ORAL 1 TABLET, DAILY, ORAL Terrcian(Cyamemazine SS ORAL 120 GTT, DAILY, ORAL Zyprexa(Olanzapine) Tablet SS ORAL 2 TABLET, DAILY, ORAL Imovane (Zopiclone) C Lepticur (Tropatepine Hydrochloride) C Date:03/24/03ISR Number: 4095326-8Report Type:Periodic Company Report #USA030126464 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Consumer Strattera Pruritus (Atomoxetine Hydrochloride) PS 40 MG/1 DAY Zyprexa-Oral (Olanazapine) (Olanazapine) SS 5 MG DAY Ritalin (Methylphenidate Hydrochloride) C Date:03/24/03ISR Number: 4095342-6Report Type:Periodic Company Report #USA030228237 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Strattera Fatigue (Atomoxetine Nausea Hydrochloride) PS 40 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/DAY Celexa (Citalopram Hydrobromide) C Date:03/24/03ISR Number: 4096377-XReport Type:Periodic Company Report #USA030126199 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Strattera Mania Professional (Atomoxetine 24-Jun-2005 12:19 PM Page: 2224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) PS 18 MG/2 DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/1 AT BEDTIME Concerta (Methykphenidate Hydrochloride) C Date:03/24/03ISR Number: 4096420-8Report Type:Periodic Company Report #USA030125661 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Strattera Nausea (Atomoxetine Weight Increased Hydrochloride) PS 80 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/DAY Celexa (Citalopram Hydrobromide) C Date:03/24/03ISR Number: 4096442-7Report Type:Periodic Company Report #USA030125769 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Strattera Disturbance In Attention (Atomoxetine Restlessness Hydrochloride) PS 25 MG IN THE Stupor MORNING Zyprexa-Oral (Olanzapine) (Olanzapine) SS ORAL 10 MG AT BEDTIME Methylphenidate Hydrochloride C Date:03/24/03ISR Number: 4097057-7Report Type:Periodic Company Report #USA030126913 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Fatigue (Atomoxetine Feeling Abnormal Hydrochoride) PS 75 MG/DAY Headache Zyprexa-Oral Hypersomnia (Olanzapine) Insomnia (Olanzapine) SS 10 MG/DAY 8 MON Somnolence Adderall C Date:03/24/03ISR Number: 4097679-3Report Type:Periodic Company Report #USA030126583 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Strattera Eye Rolling (Atomoxetine Movement Disorder Hydrochloride) PS 25 MG/DAY Sedation Zyprexa-Oral (Olanzapine) 24-Jun-2005 12:19 PM Page: 2225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS Topamax (Topiramate) C Neutrontin (Gabapentin) C Celexa (Citalopram Hydrobromide) C Clonidine C Date:03/24/03ISR Number: 4097703-8Report Type:Periodic Company Report #USA030126647 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Strattera Fatigue (Atomoxetine Insomnia Hydrochloride) PS 60 MG/1 IN THE EVENING Zyprexa-Oral (Olanzapine) (Olanzapine) SS Date:03/24/03ISR Number: 4097882-2Report Type:Periodic Company Report #USA030126494 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Consumer Strattera Vomiting (Atomoxetine Hydrochloride) PS 40 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG/DAY Zoloft (Sertraline Hydrochloride) C Depakote (Valproate Semisodium) C Date:03/24/03ISR Number: 4098168-2Report Type:Periodic Company Report #USA030127495 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Strattera (Atomoxetine Hydrochloride) PS 25 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS Adderall C Concerta (Methylphenidate Hydrochloride) C Date:03/24/03ISR Number: 4098210-9Report Type:Periodic Company Report #USA030127286 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Fatigue (Atomoxetine Psychomotor Hyperactivity Hydrochloride) PS 18 MG/1 IN THE MORNING 24-Jun-2005 12:19 PM Page: 2226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/1 AT BEDTIME Concerta (Methylphenidate Hydrochloride) C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Date:03/24/03ISR Number: 4098326-7Report Type:Periodic Company Report #USA030127338 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apathy Consumer Strattera Depression (Atomoxetine Drug Ineffective Hydrochloride) PS 60 MG/DAY Headache Zyprexa-Oral Influenza (Olanzapine) Vision Blurred (Olanzapine) SS Klonopin (Clonazepam) C Gabitril (Tiagabine Hydrochloride) C Thyroid C Vioxx (Refecoxib) C Celexa (Citalopram Hydrobromide) C Date:03/24/03ISR Number: 4098343-7Report Type:Periodic Company Report #USA030227890 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Consumer Strattera Somnolence (Atomoxetine Hydrochloride) PS 65 MG DAY Zyperxa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/1 DAY Celexa (Citalopram Hydrobromide) C Date:03/24/03ISR Number: 4098507-2Report Type:Periodic Company Report #USA030227737 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Strattera (Atomoxetine Hydrochloride) PS 80 MG/DAY Zyprexa-Oral (Olanazapine) (Olanazapine) SS 30 MG AT BEDTIME Klonopin (Clonazepam) C Tegretol 24-Jun-2005 12:19 PM Page: 2227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Carbamazepine) C Anafranil (Clomipramine Hydrochloride) C Date:03/24/03ISR Number: 4098646-6Report Type:Periodic Company Report #USA030227851 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Body Temperature Consumer Strattera Increased (Atomoxetine Hypersomnia Hydrochloride) PS 25 MG/DAY Influenza Zyprexa-Oral (Olanazapine) (Olanazapine) SS 5 MG/DAY Concerta (Methylphenidate Hydrochloride) C Remeron (Mirtazapine) C Date:03/24/03ISR Number: 4098652-1Report Type:Periodic Company Report #USA030227853 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Impulsive Behaviour Consumer Strattera Irritability (Atomoxetine Psychomotor Hyperactivity Hydrochloride) PS 18 MG/1 IN Somnolence THE EVENING Zyprexa-Oral (Olanazapine) (Olanazapine) SS 2.5 MG/1 IN THE EVENING Date:03/24/03ISR Number: 4098671-5Report Type:Periodic Company Report #USA030229330 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Strattera Professional (Atomoxetine Company Hydrochloride) PS 40 MG/DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 12.5 MG/DAY Effexor-Xr (Venlafaxine Hydrochloride) C Wellbutrin Sr (Bupropion Hydrochloride) C Date:03/24/03ISR Number: 4098762-9Report Type:Periodic Company Report #USA030228983 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Consumer Strattera (Atomoxetine Hydrochloride) PS 40 MG/1 DAY 5 DAY 24-Jun-2005 12:19 PM Page: 2228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/1 DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG/DAY Actos (Pioglitazone) C Accupril (Quinapril Hydrochloride) C Clonazepam C Glucophage (Metformin Hydrochloride) C Fluoxetine Hydrochloride C Date:03/24/03ISR Number: 4098776-9Report Type:Periodic Company Report #USA030229017 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Strattera Back Pain (Atomoxetine Chills Hydrochloride) PS 25 MG/DAILY 10 DAY Difficulty In Walking Zyprexa-Oral Dizziness (Olanzapine) Flushing (Olanzapine) SS Headache Propanolol C Heart Rate Increased Serax (Oxazepam) C Influenza Like Illness Insomnia Irritability Muscle Spasms Muscle Tightness Mydriasis Tremor Urticaria Date:03/24/03ISR Number: 4098799-XReport Type:Periodic Company Report #USA030228936 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ear Infection Health Strattera Pyrexia Professional (Atomoxetine Rash Company Hydrochloride) PS Respiratory Disorder Representative Zyprexa-Oral (Olanzapine (Olanzapine) SS Adderall C Date:03/24/03ISR Number: 4098981-1Report Type:Periodic Company Report #USA030229051 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Strattera Insomnia (Atomoxetine Muscle Spasms Hydrochloride) PS 40 MG/1 DAY 4 DAY Pain In Extremity Zyprexa-Oral 24-Jun-2005 12:19 PM Page: 2229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) (Olanzapine) SS .25 MG/2 DAY 9 MON Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG/DAY Neurontin (Gabapentin) C Date:03/24/03ISR Number: 4099855-2Report Type:Periodic Company Report #US_030292078 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pallor Consumer Strattera Skin Discolouration (Atomoxetine Somnolence Hydrochloride) PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS ORAL ORAL Amantadine C Date:03/25/03ISR Number: 4077593-XReport Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040688A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Quilonum PS Glaxosmithkline ORAL Suicide Attempt Trevilor SS ORAL Zyprexa SS ORAL 400MG per day Date:03/25/03ISR Number: 4080663-3Report Type:Direct Company Report #CTU 189456 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Bupropion Sr PS Initial or Prolonged Agitation Trazodone SS Blood Creatine Olanzapine SS Phosphokinase Increased Ziprasidone C Depression Lithium C Drug Ineffective Beclomethasone C Electrocardiogram Qt Fexofenadine C Prolonged Folic Acid C Medication Error Naproxen C Mental Status Changes Propranold C White Blood Cell Count Rabeprazole C Increased Simvastatin C Thiamine C Trazodone C Ziprasidone C Lithium C Olanzapine C Bupropion C Date:03/25/03ISR Number: 4083271-3Report Type:Expedited (15-DaCompany Report #2003AP01266 Age:52 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 2230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Cardiomyopathy Foreign Seroquel PS ORAL 600 MG DAILY Confusional State Health PO Consciousness Fluctuating Professional Olanzapine SS Myocardial Infarction Other Cipramil C Psychotic Disorder Date:03/26/03ISR Number: 4082684-3Report Type:Direct Company Report #CTU 189581 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa 5mg PS ORAL ZYPREXA 5MG Required Hyperphagia HS PO Intervention to Polydipsia Haldol C Prevent Permanent Polyuria Risperdal C Impairment/Damage Urinary Incontinence Weight Decreased Date:03/26/03ISR Number: 4082685-5Report Type:Direct Company Report #CTU 189582 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa 20mg PS ORAL 20MG HS PO Required Weight Increased Depacote SS ORAL 500 MG BID PO Intervention to Prevent Permanent Impairment/Damage Date:03/26/03ISR Number: 4084136-3Report Type:Expedited (15-DaCompany Report #NALB20030001 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bipolar Disorder Foreign Nalbuphine PS SUBCUTANEOUS 20 MG ONCE Hospitalization - Bradycardia Health SUBCU Initial or Prolonged Cardiac Arrest Professional Scopolamine SS SUBCUTANEOUS 0.5 ML ONCE Required Condition Aggravated SUBCU Intervention to Drug Interaction Olanzapine SS ORAL 30 MG PO Prevent Permanent Infection Lithium Carbonat SS ORAL 900 MG PO Impairment/Damage Inflammation Clonazepam SS ORAL 10 MG PO Mania Pantoprazol SS 40 MG Biperidine SS 2 MG Valproinat SS 3000 MG Olanzapine C Lithium Carbonat C Clonazepam C Amoxicillin/Clavulan at C Valproinat C Amoxicillin/Clavulan at C Valproinat C 24-Jun-2005 12:19 PM Page: 2231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/03ISR Number: 4084250-2Report Type:Expedited (15-DaCompany Report #HQWYE815503MAR03 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Efexor Exel Hospitalization - Agitation Professional (Venlafaxine Initial or Prolonged Attention Hydrochloride, Deficit/Hyperactivity Capsule, Extended Disorder Release) PS ORAL 75 MG 1X PER Communication Disorder 1 DAY, ORAL 28 DAY Distractibility Dominal Eye Movement Disorder (Prothipendyl Inappropriate Hydrochloride) SS ORAL 40 MG 1X PER Antidiuretic Hormone 1 DAY, ORAL Secretion Risperdal Muscle Spasms (Risperidone) SS 4 MG 1X PER 1 Speech Disorder DAY 55 DAY Zyprexa (Olanzapine) SS 5 MG (1/2 TABLET) 22 DAY Loramet (Lormetazepam) C Zantac (Ranitidine Hydrochloride) C Xanax (Alprazolam) C Lysanxia (Prazepam) C Voltaren (Diclofenac Sodium) C Dafalgan (Paracetamol) C Sodium Chloride C Ferro-Gradumet (Ferrous Sulfate) C Kemadren (Procyclidine Hydrochloride) C Fragmin (Heparin-Fraction, Sodium Salt) C Betnelan (Betamethasone) C Date:03/27/03ISR Number: 4080799-7Report Type:Direct Company Report #CTU 189635 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Olanzapine PS ORAL 2.5 MG PO QHS Initial or Prolonged Syndrome Atorvastatin C Required Benazepril C Intervention to Carvedilol C Prevent Permanent Furosemide C Impairment/Damage Spironolactone C Date:03/27/03ISR Number: 4083097-0Report Type:Expedited (15-DaCompany Report #US_020483513 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Life-Threatening Dialysis Foreign Rhabdomyolysis Literature White Blood Cell Count Health Abnormal Professional 24-Jun-2005 12:19 PM Page: 2232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 15 MG/DAY Akineton (Biperiden Hydrochloride) C Rohypnol (Flunitrazepam) C Neuleptil (Periciazine) C Noritren (Nortriptyline Hydrochloride) C Hiberna (Promethazine Hydrochloride) C Levotomin (Levomepromazine Maleate) C Contomin (Chlorpromazine Hydrochloride) C Benzalin (Nitrazepam) C Date:03/27/03ISR Number: 4084359-3Report Type:Expedited (15-DaCompany Report #USA030330854 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Date:03/27/03ISR Number: 4084361-1Report Type:Expedited (15-DaCompany Report #USA030331871 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:03/27/03ISR Number: 4084398-2Report Type:Expedited (15-DaCompany Report #USA020516368 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Literature Zyprexa-Oral Initial or Prolonged Cholelithiasis Health (Olanzapine) PS 10 MG/DAY Hepatitis Acute Professional Oscal 500-D C Hepatomegaly Centrum Silver C Liver Tenderness Tylenol Mucous Membrane Disorder (Paracetamol) C Pyrexia White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/03ISR Number: 4085871-3Report Type:Expedited (15-DaCompany Report #US_030393412 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Myeloma Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:03/27/03ISR Number: 4086546-7Report Type:Expedited (15-DaCompany Report #USA030330980 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Zyprexa-Oral Other Body Temperature Professional (Olanzapine) Increased Company (Olanzapine) PS 5 MG/DAY Delirium Tremens Representative Lexapro Mental Status Changes (Escitalopram) C Overdose Somnolence Tremor Date:03/27/03ISR Number: 4086548-0Report Type:Expedited (15-DaCompany Report #USA030331015 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Zyprexa-Oral Hospitalization - Cough Professional (Olanzapine) Initial or Prolonged (Olanzapine) PS 10 MG/3 DAY 3 DAY Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Valium (Diazepam) C Date:03/27/03ISR Number: 4086549-2Report Type:Expedited (15-DaCompany Report #USA030330823 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa-Oral Small Cell Lung Cancer Professional (Olanzapine) Stage Unspecified Company (Olanzapine) PS Representative Date:03/27/03ISR Number: 4086603-5Report Type:Expedited (15-DaCompany Report #GBS030312722 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Olanzapine-Oral Pulmonary Embolism Health (Olanzapine) PS UNKNOWN 10 MG/UNKNOWN Sudden Death Professional Aspirin C Other Ferrous Sulphate C Thyroxine C 24-Jun-2005 12:19 PM Page: 2234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/03ISR Number: 4086607-2Report Type:Expedited (15-DaCompany Report #EWC021032824 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Foreign Olanzapine-Oral Flatulence Health (Olanzapine) PS 10 MG/DAY Hepatocellular Damage Professional Epilim (Valproate Parkinsonism Company Sodium) C Representative Paroxetine C Other Date:03/27/03ISR Number: 4086609-6Report Type:Expedited (15-DaCompany Report #DE_030210690 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa-Oral Initial or Prolonged Blood Cholesterol Health (Olanzapine) Increased Professional (Olanzapine) PS 10 MG/DAY Blood Triglycerides Other Remergil Increased (Mirtazapine) C Rhabdomyolysis Benzodiazepine C Date:03/27/03ISR Number: 4086751-XReport Type:Expedited (15-DaCompany Report #US_030191994 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Olanzapine-Oral Initial or Prolonged Pneumonia Aspiration Study (Olanzapine) PS 22.5 MG DAY Health Gramalil (Tiapride Professional Hydrochloride) C Other Seroquel (Quetiapine Fumarate) C Lullan (Lullan) C Eurodin(Estazolam) C Rohypnol(Flunitrazep am) C Alosenn C Pursennid(Senna Leaf) C Nivadil(Nilvadipine) C Magnesium Oxide C Gascon(Dimeticone) C Stomachics & Digestives C Chinese Medicine C Date:03/27/03ISR Number: 4086926-XReport Type:Expedited (15-DaCompany Report #USA030330783 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Multiforme Health Zyprexa-Oral Initial or Prolonged Mental Status Changes Professional (Olanzapine) Other Company (Olanzapine) PS 15 MG/1 AT Representative BEDTIME Lithium C Risperdal (Risperidone) C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/03ISR Number: 4086927-1Report Type:Expedited (15-DaCompany Report #USA020515095 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Activities Of Daily Health Zyprexa-Oral Hospitalization - Living Impaired Professional (Olanzapine Initial or Prolonged Complications Of Maternal )(Olanzapine) PS 10 MG/DAY Disability Exposure To Therapeutic Risperdal Drugs (Risperidone) C Depression Gestational Diabetes Induced Labour Infection Pregnancy Psoriasis Rheumatoid Arthritis Date:03/27/03ISR Number: 4086949-0Report Type:Expedited (15-DaCompany Report #GBS030312744 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa-Oral Hospitalization - Renal Failure Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 48 DSG Other FORM/DAY Anadin Extra C Paroxetine C Naltrexone C Date:03/27/03ISR Number: 4086958-1Report Type:Expedited (15-DaCompany Report #EWC030334172 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bile Duct Stone Foreign Zyprexa-Oral Hospitalization - Cardiac Arrest Health (Olanzapine) Initial or Prolonged Cholecystitis Acute Professional (Olanzapine) PS 30 MG Company Quilonorm Retard Representative (Lithium Carbonate) C Other Rivotril (Clonazepam) C Augmentin C Pantoloc (Pantoprazole Sodium0 C Akineton (Biperiden Hydrochloride) C Depakine (Valproate Sodium) C Nubain (Nalbuphine Hydrochloride) C Scopolamine C Date:03/27/03ISR Number: 4086959-3Report Type:Expedited (15-DaCompany Report #JP_030300489 Age:35 YR Gender:Female I/FU:I Outcome PT Life-Threatening Depressed Level Of Consciousness Intentional Misuse 24-Jun-2005 12:19 PM Page: 2236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Ventricular Fibrillation Ventricular Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:03/27/03ISR Number: 4086960-XReport Type:Expedited (15-DaCompany Report #JP_030300476 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Oral Infarction Study (Olanzapine) Neutrophil Count Health (Olanzapine) PS 10 MG/DAY Decreased Professional Levotomin Other (Levomepromazine Maleate) C Risperdal (Risperidone) C Emilace (Nemonapride) C Tegretol (Carbamazepine) C Epirenat (Valproate Sodium) C Excegran (Zonisamide) C Rohypnol (Flunitrazepam) C Doral (Quazepam) C Laxoberon (Sodium Picosulfate) C Date:03/27/03ISR Number: 4086961-1Report Type:Expedited (15-DaCompany Report #US_021189777 Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - Akathisia Initial or Prolonged Anxiety Condition Aggravated Constipation Conversion Disorder Delusion Depression Diarrhoea Drug Ineffective Dyskinesia Excitability Hallucination Headache Hyperhidrosis Increased Appetite Initial Insomnia Irritability Menstrual Disorder Musculoskeletal 24-Jun-2005 12:19 PM Page: 2237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Discomfort Nasopharyngitis Salivary Hypersecretion Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Thirst Foreign Olanzapine-Oral Tremor Study (Olanzapine) PS 10 MG DAY Health Silece Professional (Flunitrazepam) C Other Lendormin (Brotizolam) C Pydoxal (Pyridoxal Phosphate) C Constan (Alprazolam) C Horizon (Diazepam) C Date:03/27/03ISR Number: 4086962-3Report Type:Expedited (15-DaCompany Report #US_030393174 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Foreign Olanzapine-Oral Initial or Prolonged Pulmonary Disease Study (Olanzapine) PS 20 MG/DAY Obesity Health Professional Other Date:03/27/03ISR Number: 4086964-7Report Type:Expedited (15-DaCompany Report #FR_030302161 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Viral Myositis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Other Date:03/28/03ISR Number: 4083386-XReport Type:Direct Company Report #CTU 189697 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Zyprexa 15mg Qd PS ORAL 5MG PO QHS Initial or Prolonged Diabetes Mellitus Non-Insulin-Dependent Diabetic Ketoacidosis Metabolic Acidosis Nausea Vomiting Date:03/28/03ISR Number: 4083695-4Report Type:Direct Company Report #CTU 189721 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Olanzapine PS 10 MG Intervention to Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 2238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/03ISR Number: 4086782-XReport Type:Expedited (15-DaCompany Report #03P-062-0211080-00 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Akineton(Biperiden) Initial or Prolonged Mydriasis Health (Biperiden) PS ORAL 2 MG, 19 IN 1 Required Overdose Professional ONCE, PER Intervention to Pneumonia Aspiration ORAL Prevent Permanent Respiratory Failure Chlorazepam SS ORAL 5 MG, 3 IN 1 Impairment/Damage Salivary Hypersecretion ONCE, PER Suicide Attempt ORAL Sertraline Hydrocloride SS ORAL 50 MG, 10 IN 1 ONCE, PER ORAL Clozapine SS ORAL 100 MG, 40 IN ONCE, PER ORAL Parstelin SS ORAL 16 TABLET, 1 IN 1 ONCE, PER ORAL Diazepam SS ORAL 10 MG, 15 IN 1 ONCE, PER ORAL Prothipendyl Hydrochloride SS ORAL 80 MCG, 20 IN 1 ONCE, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 ONCE, PER ORAL Date:03/31/03ISR Number: 4085615-5Report Type:Expedited (15-DaCompany Report #NSADSS2003007614 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Induced Health Topamax (Topiramate) PS UTERINE Anencephaly Professional Zyprexia Complications Of Maternal (Olanzapine) SS 10 MG, DAILY, Exposure To Therapeutic UTERINE Drugs Maternal Drugs Affecting Foetus Pregnancy Date:04/01/03ISR Number: 4084777-3Report Type:Direct Company Report #CTU 189857 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Palpitations Olanzapine Wafer Intervention to 20mg PS ORAL 20MG HS ORAL Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 2239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4084902-4Report Type:Direct Company Report #CTU 189924 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthma Risperdal PS 2.3 MG DAILY Hospitalization - Blood Pressure Decreased PILL Initial or Prolonged Body Temperature Zyprexa SS 20 MG, 10MG, Disability Decreased 2.5MG PILL Other Cerebrovascular Accident Zoloft SS 100 MG, 50 Required Coma MG, 25 MG Intervention to Convulsion Effexor SS Prevent Permanent Cyst Elavil SS Impairment/Damage Encephalomalacia Tegretol C Extrapyramidal Disorder Depakote C Fungal Infection Gabitril C Gastrooesophageal Reflux Claritin C Disease Synthroid C Haematoma Advair Discus C Heart Rate Increased Keppra C Hypothyroidism Felbamate C Joint Stiffness Zonegran C Ovarian Disorder Prevacid C Pain Allegra C Psychomotor Hyperactivity Lodine Xl C Rash Flonase C Rhinitis Ativan C Scleroderma Cogentin C Skin Lesion Amantadine C Sleep Apnoea Syndrome Benadryl C Status Epilepticus Clonopin C Syncope Haldol C Uterine Disorder Seroquel C Visual Disturbance Elavil C Weight Decreased Effexor C Date:04/02/03ISR Number: 4087041-1Report Type:Direct Company Report #CTU 190115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Zyprexa 5 Mg Lilly PS ORAL 5 MG BID ORAL Initial or Prolonged Hypersensitivity Paxil C Date:04/04/03ISR Number: 4085215-7Report Type:Expedited (15-DaCompany Report #AT-ROCHE-335077 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Rivotril PS Roche ORAL 2 DAY Cardiac Failure Acute Rivotril SS Roche ORAL 4 DAY Mania Zyprexa SS ORAL 13 DAY Quilonorm Retard SS ORAL 13 DAY Augmentin SS ORAL 3 DAY Augmentin SS ORAL Augmentin SS ORAL 7 DAY Depakine SS ORAL Depakine SS ORAL Depakine SS ORAL 26 DAY Depakine SS ORAL 2 DAY Nubain SS SUBCUTANEOUS STRENGTH 20 MG/2ML. GIVEN IN THE 24-Jun-2005 12:19 PM Page: 2240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report EVENING. Scopolamine SS Roche SUBCUTANEOUS GIVEN IN THE EVENING. Pantoloc C ORAL Akineton C ORAL 2 DAY Date:04/04/03ISR Number: 4089691-5Report Type:Expedited (15-DaCompany Report #USA030331656 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Strattera Initial or Prolonged Syncope Professional (Atomoxetine Other Company Hydrochloride) PS 2 DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS Depakote (Valproate Semisodium) C Date:04/04/03ISR Number: 4089738-6Report Type:Expedited (15-DaCompany Report #USA030331378 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Health Zyprexa Transient Ischaemic Professional Zydis-Dispersible Attack (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:04/04/03ISR Number: 4089902-6Report Type:Expedited (15-DaCompany Report #US_030393331 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Literature Olanzapine-Oral Corrected Interval Health (Olanzapine) PS 20 MG/2 DAY 11 DAY Prolonged Professional Tachycardia Date:04/04/03ISR Number: 4090086-9Report Type:Expedited (15-DaCompany Report #USA030331875 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Intracranial Health Zyprexa -Oral Hypertension Professional (Olanzapine) Company (Olanzapine) PS Representative Date:04/04/03ISR Number: 4090117-6Report Type:Expedited (15-DaCompany Report #USA030331541 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Agitation Professional (Olanzapine) Diverticular Perforation (Olanzapine) PS 80 MG/DAY Diverticulitis Depakote (Valproate Hostility Semisodium) C Psychotic Disorder Prolixin (Fluphenazine 24-Jun-2005 12:19 PM Page: 2241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Klonopin (Clonazepam) C Levaquin (Levofloxacin) C Flagyl(Metronidazole ) C Date:04/04/03ISR Number: 4090118-8Report Type:Expedited (15-DaCompany Report #USA030331497 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Consumer Zyprexa - Oral Initial or Prolonged Pulmonary Embolism (Olanzapine) Other (Olanzapine) PS 40 MG/DAY Date:04/04/03ISR Number: 4090153-XReport Type:Expedited (15-DaCompany Report #USA030228646 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anencephaly Health Zyprexa-Oral Complications Of Maternal Professional (Olanzapine) Exposure To Therapeutic Other (Olanzapine) PS Drugs Topamax (Topiramate) C Maternal Drugs Affecting Foetus Pregnancy Date:04/04/03ISR Number: 4090270-4Report Type:Expedited (15-DaCompany Report #JP_030300531 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Triglycerides Foreign Olanzapine-Oral Increased Study (Olanzapine) PS 10 MG DAY Disease Recurrence Health Risperdal Dyskinesia Professional (Risperidone) C Hyperlipidaemia Other Tasmolin (Biperiden) C Schizophrenia, Disorganised Type Weight Increased Date:04/04/03ISR Number: 4090273-XReport Type:Expedited (15-DaCompany Report #JP_030300532 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Olanzapine-Oral Initial or Prolonged Excitability Study (Olanzapine) PS 20 MG DAY Schizophrenia Health Risperdal Professional (Risperidone) C Other Akineton (Biperiden Hydrochloride) C Ubretid (Distigmine Bromide) C Brotizolam C Benzalin (Nitrazepam) C Vegetamin A C Pursennid (Senna 24-Jun-2005 12:19 PM Page: 2242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leaf) C Lexotan (Bromazepam) C Date:04/04/03ISR Number: 4090276-5Report Type:Expedited (15-DaCompany Report #JP_030300549 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Blood Urea Professional (Olanzapine) PS 5 MG/DAY Condition Aggravated Company Cold Medication C Haemorrhage Representative Hepatic Cirrhosis Other Somnolence Date:04/04/03ISR Number: 4090279-0Report Type:Expedited (15-DaCompany Report #JP_030300503 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperammonaemia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Levotomin Representative (Levomepromazine Other Maleate) C Valerin (Valproate Sodium) C Thyradin S (Levothyroxine Sodium) C Pursennid (Senna Leaf) C Date:04/04/03ISR Number: 4090282-0Report Type:Expedited (15-DaCompany Report #JP_030300513 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperammonaemia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Valerin (Valproate Representative Sodium) C Other Pursennid (Senna Leaf) C Magnesium Oxide C Date:04/04/03ISR Number: 4090285-6Report Type:Expedited (15-DaCompany Report #JP_030300520 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Auricular Swelling Foreign Zyprexa-Oral Initial or Prolonged Deafness Neurosensory Health (Olanzapine) Dizziness Professional (Olanzapine) PS 10MG/DAY Nausea Company Palgin C Sudden Hearing Loss Representative Tinnitus Other 24-Jun-2005 12:19 PM Page: 2243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4090287-XReport Type:Expedited (15-DaCompany Report #FR_030302189 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Zyprexa-Oral Asthenia Health (Olanzapine) Prothrombin Time Professional (Olanzapine) PS 20 MG/DAY Shortened Other Xanax (Alprazolam) C Thrombocytopenia Date:04/04/03ISR Number: 4090291-1Report Type:Expedited (15-DaCompany Report #FR_030302176 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Foreign Zyprexa-Oral Neonatal Health (Olanzapine) Dystonia Professional (Olanzapine) PS Maternal Drugs Affecting Other Foetus Neonatal Disorder Date:04/04/03ISR Number: 4090294-7Report Type:Expedited (15-DaCompany Report #FR_030302177 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperpyrexia Foreign Zyprexa-Oral Initial or Prolonged Hypertonia Health (Olanzapine) Neuroleptic Malignant Professional (Olanzapine PS 5 MG/DAY Syndrome Company Tiapridal (Tiapride) C Representative Other Date:04/04/03ISR Number: 4090389-8Report Type:Expedited (15-DaCompany Report #US_030393313 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Olanzapine-Oral Initial or Prolonged Bradyphrenia Literature (Olanzapine) PS 10 MG Other Mutism Health Lorazepam C Suicide Attempt Professional Other Date:04/04/03ISR Number: 4090395-3Report Type:Expedited (15-DaCompany Report #FR_020901453 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine Professional )(Olanzapine) PS 20 MG/DAY Company Anticoagulant Representative Citrate Dextrose C Other 24-Jun-2005 12:19 PM Page: 2244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4090400-4Report Type:Expedited (15-DaCompany Report #EWC030334275 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:04/04/03ISR Number: 4090404-1Report Type:Expedited (15-DaCompany Report #JP_030300476 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Oral Infarction Study (Olanzapine) Neutrophil Count Health (Olanzapine) PS 10 MG/DAY Decreased Professional Levotomin Other (Levomepromazine Maleate) C Risperdal (Risperidone) C Emilace (Nemonapride) C Tegretol(Carbamazepi ne) C Epirenat (Valproate Sodium) C Excegran (Zonisamide) C Rohypnol (Flunitrazepam) C Doral (Quazepam) C Laxoberon (Sodium Picosulfate) C Date:04/04/03ISR Number: 4090416-8Report Type:Expedited (15-DaCompany Report #JP_030300528 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Increased Study (Olanzapine)(Olanzap Aspartate Health ine) PS 10 MG/1 DAY Aminotransferase Professional Serenace Increased Other (Haloperidol) C Blood Lactate Contomin Dehydrogenase Increased (Chlorpromazine Cardio-Respiratory Arrest Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Myslee (Zolpidem Tartrate) C Lendormin (Brotizolam) C Doral (Quazepam) C 24-Jun-2005 12:19 PM Page: 2245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4090555-1Report Type:Expedited (15-DaCompany Report #US_030393462 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Foreign Zyprexa-Oral Gingival Bleeding Consumer (Olanzapine) Petechiae Other (Olanzapine) PS 5 MG/DAYI Thrombocytopenia Melleril Vaginal Haemorrhage (Thioridazine Hydrochloride) C Date:04/04/03ISR Number: 4090582-4Report Type:Expedited (15-DaCompany Report #JP_030300456 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Foreign Zyprexa-Oral Ear Disorder Health (Olanzapine) Ear Haemorrhage Professional (Olanzapine) PS ORAL 5 MG/DAY Fall Company Depromel C Heart Injury Representative Meilax C Loss Of Consciousness Date:04/04/03ISR Number: 4090584-8Report Type:Expedited (15-DaCompany Report #GBS021011773 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Olanzapine-Oral Hospitalization - Apnoea Consumer (Olanzapine) PS ORAL 7.5 MG/IN THE Initial or Prolonged Blood Sodium Decreased Health EVENING Other Depressed Mood Professional Epilim(Valproate Dyspnoea Sodium) C Epilepsy Tegretol Epileptic Aura (Carbamazepine) C Grand Mal Convulsion Diazepam C Myocardial Infarction Nu-Seals Paranoia Aspirin(Acetylsalicy Tongue Biting lic Acid) C Pulmicort(Budesonide ) C Combivent C Gamanil(Lofepramine Hydrochloride) C Date:04/04/03ISR Number: 4090589-7Report Type:Expedited (15-DaCompany Report #JP_030100328 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dementia Foreign Zyprexa-Oral Eye Rolling Study (Olanzapine) Restlessness Health (Olanzapine) PS ORAL 10 MG/DAY Professional Orap(Pimozide) C Company Artane(Trihexyphenid Representative yl Hydrochloride) C Lexotan(Bromazepam) C Metligine(Midodrine Hydrochloride) C Cabagin-U Tab. (Vitamin U) C 24-Jun-2005 12:19 PM Page: 2246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4090593-9Report Type:Expedited (15-DaCompany Report #US_030292496 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Foreign Olanzapine-Oral Initial or Prolonged Increased Study (Olanzapine) PS ORAL 10 MG/DAY Constipation Health Akineton C Hepatic Function Abnormal Professional Rohypnol C Parkinsonism Selbex C Date:04/04/03ISR Number: 4090629-5Report Type:Expedited (15-DaCompany Report #EWC021032824 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Foreign Olanzapine-Oral Flatulence Health (Olanzapine) PS 10 MG/DAY Hepatocellular Damage Professional Epilim (Valproate Parkinsonism Company Sodium) C Representative Paroxetine C Other Date:04/08/03ISR Number: 4091879-4Report Type:Expedited (15-DaCompany Report #03P-009-0214904-00 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Depakine Hospitalization - Cardiac Arrest Health (Depakene)(Sodium Initial or Prolonged Drug Level Above Professional Valproate/Valproic Therapeutic Acid) (Sodium Inflammation Valproate/Valproic PS ORAL SEE IMAGE Oxygen Saturation Olanzapine SS ORAL 30 MG, 1 IN 1 Decreased D, PER ORAL Pyrexia Lithium Carbonate SS ORAL PER ORAL Self-Medication Nalbuphine Shock Hydrochloride SS SUBCUTANEOUS 20 MG, 1 IN 1 Toxicologic Test Abnormal D, SUBCUTANEOUS Hyoscine SS SUBCUTANEOUS 0.5 ML, 1 IN 1 D, SUBCUTANEOUS Clonazepam SS ORAL 16 MG, 1 IN 1 D, PER ORAL .... C Amoxicillin Trihydrate C Pantoprazole C Biperiden C Date:04/10/03ISR Number: 4093326-5Report Type:Expedited (15-DaCompany Report #GBS030312871 Age:22 YR Gender:Male I/FU:I Outcome PT Hospitalization - Angina Pectoris Initial or Prolonged Arrhythmia Other Chest Pain Diabetic Coma Haematemesis Haematochezia Hyperchlorhydria 24-Jun-2005 12:19 PM Page: 2247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Peptic Ulcer Speech Disorder Tachycardia Report Source Product Role Manufacturer Route Dose Duration Tetany Foreign Olanzapine-Oral Weight Decreased Health (Olanzapine) PS 5 MG Professional Other Date:04/10/03ISR Number: 4093328-9Report Type:Expedited (15-DaCompany Report #GBS030312886 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Zyprexa-Oral Other Tachycardia Health (Olanzapine) Ventricular Extrasystoles Professional (Olanzapine) PS 20 MG/DAY Other Procyclidine C Depakote (Valproate Semisodium) C Diazepam C Haloperidol C Date:04/10/03ISR Number: 4093330-7Report Type:Expedited (15-DaCompany Report #GBS030312897 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG Professional Paracetamol C Other Dihydrocodeine C Date:04/10/03ISR Number: 4093364-2Report Type:Expedited (15-DaCompany Report #JP_030300564 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Olanzapine-Oral Infarction Study (Olanzapine) PS 10 MG/DAY Asthenia Health Mercazole Depressed Level Of Professional (Thiamazole) C Consciousness Other Limas (Lithium Gait Disturbance Carbonate) C Akineton (Biperiden Hydrochloride) C Barnetil (Sultopride) C Vegetamin B C Rhythmy (Rilmazafone) C Gatifloxacin C Date:04/10/03ISR Number: 4093532-XReport Type:Expedited (15-DaCompany Report #EWC030334389 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Back Pain Other C-Reactive Protein Increased 24-Jun-2005 12:19 PM Page: 2248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cholestasis Dehydration Diabetes Mellitus Report Source Product Role Manufacturer Route Dose Duration Non-Insulin-Dependent Foreign Zyprexa-Oral Epigastric Discomfort Consumer (Olanzapine) Fluid Retention Health (Olanzapine) PS 5 MG Haemoglobin Increased Professional Metformin C Hepatic Steatosis Other Hepatitis Hypertriglyceridaemia Ketoacidosis Nervousness Pancreatitis Schizophrenia White Blood Cell Count Increased Date:04/10/03ISR Number: 4093533-1Report Type:Expedited (15-DaCompany Report #US_020483513 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Zyprexa-Oral Rhabdomyolysis Literature (Olanzapine) Tremor Health (Olanzapine) PS 15 MG/DAY White Blood Cell Count Professional Akineton(Biperiden Increased Company Hydrochloride) C Representative Rohypnol(Flunitrazep Other am) C Neuleptil(Periciazin e) C Hiberna(Promethazine Hydrochloride) C Levotomin(Levomeprom azine Maleate) C Benzalin(Nitrazepam) C Date:04/10/03ISR Number: 4093559-8Report Type:Expedited (15-DaCompany Report #DE_030310958 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Foreign Zyprexa-Oral Hospitalization - Coagulopathy Health (Olanzapine) Initial or Prolonged Depressed Level Of Professional (Olanzapine) PS 5 MG/DAY Consciousness Other Nacom - Slow Release C Lower Gastrointestinal Haemorrhage Shock Date:04/10/03ISR Number: 4093655-5Report Type:Expedited (15-DaCompany Report #JP_030100328 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Other Dementia Foreign Dysphagia Study Insomnia Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 2249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/DAY Orap (Pimozide) C Artane (Trihexyphenidyl Hydrochloride) C Lexotan (Bromazepam) C Metligine (Midodrine Hydrochloride) C Cabagin-U Tab. (Vitamin U) C Date:04/10/03ISR Number: 4093656-7Report Type:Expedited (15-DaCompany Report #JP_030300476 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Decreased Foreign Zyprexa-Oral Depressed Level Of Study (Olanzapine) Consciousness Health (Olanzapine) PS 10 MG/DAY Incontinence Professional Levotomin Neutrophil Count Other (Levomepromazine Decreased Maleate) C Pallor Risperdal Psychogenic Pain Disorder (Risperidone) C Shock Emilace Sudden Death (Nemonapride) C Tegretol (Carbamazepine) C Epirenat (Valproate Sodium) C Excegran (Zonisamide) C Rohypnol (Flunitrazepam) C Doral (Quazepam) C ... C Laxoberon (Sodium Picosulfate) C Date:04/10/03ISR Number: 4093657-9Report Type:Expedited (15-DaCompany Report #JP_030300489 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zyprexa-Oral Consciousness Health (Olanzapine) Electrocardiogram Qt Professional (Olanzapine) PS Prolonged Company Fall Representative Intentional Misuse Speech Disorder Suicidal Ideation Suicide Attempt Ventricular Fibrillation Ventricular Tachycardia 24-Jun-2005 12:19 PM Page: 2250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/03ISR Number: 4093665-8Report Type:Expedited (15-DaCompany Report #CA_021005447 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Foreign Olanzapine Oral Alcohol Interaction Health (Olanzapine) PS 25 MG/DAY Arrhythmia Professional Clonazepam C Pulmonary Congestion Company Procyclid Pulmonary Oedema Representative (Procyclidine Other Hydrochloride) C Date:04/10/03ISR Number: 4093721-4Report Type:Expedited (15-DaCompany Report #USA-2002-0001280 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Oxycontin Tablets 40 Condition Aggravated Health Mg(Oxycodone Drug Toxicity Professional Hydrochloride) Cr Emotional Disorder Other Tablet PS ORAL 40 MG, BID, Pain ORAL Splenomegaly Oxycontin Tablets 20mg (Oxycodone Hydrochloride) SS 20 MG 14 DAY Meperidine Hydrochloride (Pethidine Hydrochloride) Unknown SS 14 DAY Propoxyphene (Dextropropoxyphene) SS 14 DAY Klonopin (Clonazepam) SS ORAL SEE IMAGE Zyprexa (Olanzapine) Unknown SS ORAL 10 MG, NOCTE, ORAL Acetaminophen (Paracetamol) Unknown SS 14 DAY Hydrocodone W/Acetaminophen C Alprazolam (Alprazolam) C Trimox (Amoxicillin Trihydrate) C Promethazine W/Codeine "Pharm Basic" (Promethazine Hydrochloride) C Diazepam (Diazepam) C Roxicet C Trimetoprim-Sulfa (Trimethoprim, Sulfamethoxazole) C Loperamide (Loperamide) C Carisoprodol (Carisoprodol) C Acetaminophen W/Codeine C Ibuprofen C Prozac (Fluoxetine 24-Jun-2005 12:19 PM Page: 2251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Depo Provera (Medroxyprogesterone Acetate) C Naproxen Sodium (Naproxen Sodium) C Carbamazepine (Carbamazepine) C Ampicillin (Ampicillin) C Prozac (Fluoxetine Hydrochloride) C Soma (Carisoprodol) C Date:04/10/03ISR Number: 4093807-4Report Type:Expedited (15-DaCompany Report #US_021088725 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Olanzapine- Oral Initial or Prolonged Anaemia Study (Olanzapine) PS 10 MG/2 DAY Blood Cholesterol Health Contomin Increased Professional (Chlorpromazine Constipation Other Hydrochloride) C Decreased Appetite Neuleptil Fatigue (Periciazine) C Hepatitis Serenace Insomnia (Haloperidol) C Mental Impairment Artane Renal Impairment (Thihexyphenidyl White Blood Cell Count Hydrochloride) C Decreased Vegetamin A C Silece (Flunitrazepam) C Pursennid (Senna Leaf) C Levotomin (Levomepromazine Maleate) C Magnesium Oxide C Laxoberon (Sodium Picosulfate) C Date:04/10/03ISR Number: 4093906-7Report Type:Expedited (15-DaCompany Report #USA030332235 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:04/10/03ISR Number: 4093927-4Report Type:Expedited (15-DaCompany Report #USA030332293 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Contusion Consumer Prozac-Oral Initial or Prolonged Drug Dependence (Fluoxetine) Disability Road Traffic Accident (Fluoxetine Other Tremor Hydrochloride) PS 20 MG/DAY 24-Jun-2005 12:19 PM Page: 2252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa-Oral (Olanzapine) (Olanzapine) SS Date:04/10/03ISR Number: 4093949-3Report Type:Expedited (15-DaCompany Report #USA030126590 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activities Of Daily Health Zyprexa-Oral Other Living Impaired Professional (Olanzapine) Cardiac Arrest Company (Olanzapine) PS 10 MG/DAY Coma Representative Thorazine Depressed Level Of (Chlorpromazine Consciousness Hydrohcloride) C Drug Interaction Cogentin Faecal Incontinence (Benzatropine Movement Disorder Mesilate) C Nausea Neuroleptic Malignant Syndrome Productive Cough Pyrexia Stress Thirst Tremor Urinary Incontinence Date:04/14/03ISR Number: 4091782-XReport Type:Direct Company Report #CTU 190782 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Zyprexa 4mgs, And Epistaxis 7and A Half Mgs PS 10MGS. Weight Increased Date:04/14/03ISR Number: 4092216-1Report Type:Direct Company Report #CTU 190786 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Zyprexa PS Initial or Prolonged Sleep Disorder Celexa SS Celexa C Pragil C Date:04/15/03ISR Number: 4095270-6Report Type:Expedited (15-DaCompany Report #USA030330783 Age:71 YR Gender:Male I/FU:F Outcome PT Hospitalization - Body Temperature Initial or Prolonged Increased Other Dermatitis Drug Hypersensitivity Eating Disorder Eosinophil Count Erythema Multiforme Gram Stain Negative Lymphocyte Count 24-Jun-2005 12:19 PM Page: 2253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Status Changes Rash Maculo-Papular Stevens-Johnson Syndrome Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 15 MG/1 AT Representative BEDTIME Lithium C Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Date:04/15/03ISR Number: 4095591-7Report Type:Expedited (15-DaCompany Report #USA030332850 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Aggression (Olanzapine) Other Breast Cancer (Olanzapine) PS 10 MG DAY 28 MON Depression Neurontin Difficulty In Walking (Gabapentin) C Dysarthria Zoloft (Sertraline Fall Hydrochloride) C Fatigue Ativan (Lorazepam) C Feeling Abnormal Aspirin C Medication Error Synthroid (Levothyroxine Sodium) C Multivitamin C Calcium C Date:04/15/03ISR Number: 4095593-0Report Type:Expedited (15-DaCompany Report #USA030332633 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Zyprexa-Oral Other Professional (Olanzapine) Company (Olanzapine) PS UNKNOWN 15 MG/DAY Representative Norvasc (Amlodipine Besilate) C Aldactazide C Date:04/15/03ISR Number: 4095668-6Report Type:Expedited (15-DaCompany Report #US_030493755 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Literature Olanzapine-Oral Neutropenia Health (Olanzapine) PS 30 MG/DAY Professional Haloperidol C Lorazepam C 24-Jun-2005 12:19 PM Page: 2254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4095676-5Report Type:Expedited (15-DaCompany Report #US_030493865 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) PS Date:04/15/03ISR Number: 4095679-0Report Type:Expedited (15-DaCompany Report #US_030493837 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Health Zyprexa-Oral Initial or Prolonged Overdose Professional (Olanzapine) PS Company Representative Date:04/15/03ISR Number: 4095684-4Report Type:Expedited (15-DaCompany Report #USA030432987 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Depression Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS 20 MG/DAY Company Representative Date:04/15/03ISR Number: 4095687-XReport Type:Expedited (15-DaCompany Report #USA030432956 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Unilateral Health Zyprexa-Oral Visual Acuity Reduced Professional (Loanzapine) PS Date:04/15/03ISR Number: 4095796-5Report Type:Expedited (15-DaCompany Report #US_030493792 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Olanzapine-Oral Initial or Prolonged Grand Mal Convulsion Literature (Olanzapine) PS ORAL 20 MG/DAY 1 DAY Other Neuroleptic Malignant Health Flufenazin Syndrome Professional (Fluphenazine Renal Impairment Other Hydrochloride) C Rhabdomyolysis Date:04/15/03ISR Number: 4095801-6Report Type:Expedited (15-DaCompany Report #FR_030402262 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Zyprexa-Oral Hospitalization - Death Health (Olanzapine)(Olanzap Initial or Prolonged Intentional Misuse Professional ine) PS ORAL 17.5 MG/DAY Lung Disorder Company Stilnox(Zolpidem) C Representative Clopixol - Slow Other Release(Zuclopenthix ol Decanoate) C Tiapridal (Tiapride) C 24-Jun-2005 12:19 PM Page: 2255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4095804-1Report Type:Expedited (15-DaCompany Report #FR_030302234 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Zyprexa -Oral Initial or Prolonged Cytolytic Hepatitis Other (Olanzapine) Haemolysis (Olanzapine) PS ORAL 10 MG/DAY Inflammation Effexor (Venlafaxine Hydrochloride) C Haldol(Haloperidol) C Xanax (Alprazolam) C Stilnox (Zolpidem) C Date:04/15/03ISR Number: 4095806-5Report Type:Expedited (15-DaCompany Report #FR_030302232 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa - Oral Initial or Prolonged Hypothermia Health (Olanzapine) Malaise Professional (Olanzapine) PS ORAL 10 MG/DAY Other Date:04/15/03ISR Number: 4096038-7Report Type:Expedited (15-DaCompany Report #GBS030312886 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Refusal Of Treatment By Foreign Zyprexa-Oral Other Patient Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Procyclidine C Depakote (Valproate Semisodium) C Diazepam C Haloperidol C Date:04/15/03ISR Number: 4096303-3Report Type:Expedited (15-DaCompany Report #AU_030306126 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Foreign Olanzapine-Oral Initial or Prolonged Clonic Convulsion Literature (Olanzapine) PS 10 MG/DAY Other Cognitive Deterioration Health Anticoagulant C Electroencephalogram Professional Abnormal Other Epilepsy Hypotension Memory Impairment Psychotic Disorder Sluggishness Social Avoidant Behaviour Somnolence Thalassaemia Beta Thrombocytopenia Tremor 24-Jun-2005 12:19 PM Page: 2256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4096413-0Report Type:Expedited (15-DaCompany Report #DE_030411063 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Olanzapine-Oral Initial or Prolonged Depression Literature (Olanzapine) PS 20 MG/DAY Epilepsy Health Flupentixol C Euphoric Mood Professional Carbamazepine C Insomnia Other Haloperidol C Mania Schizoaffective Disorder Date:04/15/03ISR Number: 4096417-8Report Type:Expedited (15-DaCompany Report #DE_030411064 Age:69 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Foreign Olanzapine-Oral Electroencephalogram Literature (Olanzapine) PS Abnormal Health Memory Impairment Professional Overdose Other Visual Acuity Reduced Date:04/15/03ISR Number: 4096567-6Report Type:Expedited (15-DaCompany Report #EWC030434497 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Foreign Zyprexa-Oral Initial or Prolonged Aphasia Health (Olanzapine) Bowel Sounds Abnormal Professional (Olanzapine) PS 1000 MG Communication Disorder Other Dry Mouth Inappropriate Affect Incoherent Muscle Twitching Overdose Restless Legs Syndrome Supraventricular Tachycardia Date:04/15/03ISR Number: 4096569-XReport Type:Expedited (15-DaCompany Report #EWC030434446 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Haldol Decanoate (Haloperidol Dacanoate) C Date:04/15/03ISR Number: 4096571-8Report Type:Expedited (15-DaCompany Report #JP_030400645 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Death Choking Foreign Health Professional 24-Jun-2005 12:19 PM Page: 2257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 2.5 MG/DAY Seroquel (Quetiapine Fumarate) C Date:04/15/03ISR Number: 4096573-1Report Type:Expedited (15-DaCompany Report #JP_030400643 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:04/15/03ISR Number: 4096574-3Report Type:Expedited (15-DaCompany Report #GBS030312908 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Zyprexa-Oral Exposure To Therapeutic Health (Olanzapine) Drugs Professional (Olanzapine) PS Maternal Drugs Affecting Other Foetus Premature Baby Stillbirth Date:04/15/03ISR Number: 4096767-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01492 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Foreign Carbamazepine Drug Interaction Health (Carbamazepine) PS ORAL 300 MG/DAY, Restlessness Professional ORAL Other Olanzapine (Olanzapine) SS ORAL 12.5 MG/DAY, ORAL Mirtazapine (Mirtazapine) C Aspirine C Simvastatin C Date:04/16/03ISR Number: 4094587-9Report Type:Direct Company Report #CTU 191128 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Lisinopril PS Initial or Prolonged Olanzapine SS Sildenafil C 24-Jun-2005 12:19 PM Page: 2258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/03ISR Number: 4096652-9Report Type:Direct Company Report #CTU 191011 Age:38 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Zyprexa 7.5 Mgm PS ORAL 7.5 MGM 1X Difficulty In Walking ORAL Feeling Drunk Tremor Date:04/17/03ISR Number: 4095199-3Report Type:Direct Company Report #CTU 191136 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Celexa 10-60 Mg PS ORAL 10-60 MG ONCE Chills A DAY ORAL Diarrhoea Zyprexa 1.3-2.5 Mg SS ORAL 1.3-2.5 ONCE Dizziness A DAY ORAL Flushing Headache Nausea Pain Paraesthesia Pyrexia Sleep Disorder Tremor Vomiting Date:04/18/03ISR Number: 4098571-0Report Type:Expedited (15-DaCompany Report #2003-04-1214 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Temodar Fatigue Professional (Temozolomide) Gait Disturbance Capsules PS ORAL 100 MG QD Somnolence ORAL Zyprexa (Olanzapine) Tablets SS ORAL 5 MG QD ORAL Zoloft Tablets C Zofran (Ondansetron) C Date:04/21/03ISR Number: 4099271-3Report Type:Expedited (15-DaCompany Report #03P-009-0214904-00 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Depakine (Depakene) Hospitalization - Drug Level Increased Health (Sodium Initial or Prolonged Inflammation Professional Valproate/Valproic Mania Acid) (Sodium Oxygen Saturation Depakine (Depakene) PS SEE IMAGE Decreased Olanzapine SS ORAL 30 MG, 1 IN 1 Pneumonia D, PER ORAL Self-Medication Lithium Carbonate SS ORAL PER ORAL Shock Clonazepam SS ORAL 16 MG, 1 IN 1 D, PER ORAL Nalbuphine Hydrochloride SS SUBCUTANEOUS 20 MG, 1 IN 1 D, SUBCUTANEOUS Hyoscine SS SUBCUTANEOUS 0.5 ML, 1 IN 24-Jun-2005 12:19 PM Page: 2259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 D, SUBCUTANEOUS Date:04/21/03ISR Number: 4099562-6Report Type:Expedited (15-DaCompany Report #2003-DE-00014GD Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Lithium Carbonate Initial or Prolonged Anxiety (Lithium Carbonate) PS 600 MG > 3 Bipolar Disorder MONTHS Body Temperature Risperidone Increased (Risperidone) SS 3 MG Catatonia Paroxetine Cognitive Disorder (Paroxetine) SS 20 MG Constipation Olanzapine Drug Interaction (Antipsychotics) SS 5 MG Drug Level Below Benztropine Therapeutic (Benzatropine Drug Level Increased Mesilate) SS 2 MG Dry Mouth Nortriptyline Insomnia (Nortriptyline) SS 50 MG Parkinsonism Tremor Vision Blurred Date:04/22/03ISR Number: 4099889-8Report Type:Expedited (15-DaCompany Report #JP_030400701 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Epistaxis Foreign Zyprexa Neutrophil Count Health (Olanazapine) PS 10 MG/DAY Decreased Professional Levotomin Pallor Company (Levomepromazine Representative Maleate) C Other Date:04/22/03ISR Number: 4099892-8Report Type:Expedited (15-DaCompany Report #DE_030411060 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa PS 7.5 MG/DAY Initial or Prolonged Circulatory Collapse Health Zyprexa Velotab-Oral Coma Professional (Olanzapine) Hypotension Other (Olanzapine) SS 10 MG/DAY Sick Sinus Syndrome Tafil(Alprazolam) C Syncope Dipiperon(Pipamperon e) C Tavor(Lorazepam) C Date:04/22/03ISR Number: 4099916-8Report Type:Expedited (15-DaCompany Report #EWC030233845 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Zyprexa PS OCCLUSIVE Health DRESSING 5 MG/DAY Professional Orfidal Other (Lorazepam) C Vandral 24-Jun-2005 12:19 PM Page: 2260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Venlafaxine Hydrochloride) C Date:04/22/03ISR Number: 4099923-5Report Type:Expedited (15-DaCompany Report #EWC030434514 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 20 MG/DAY Depression Health Apo-Diazepam Treatment Noncompliance Professional (Diazepam) C Other Remeron (Mirtazapine) C Plegomazim (Chlorpromazine Hydrochloride) C Geratam (Piracetam) C Siofor (Metformin Hydrochloride) C Date:04/22/03ISR Number: 4099927-2Report Type:Expedited (15-DaCompany Report #JP_030400671 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Foreign Olanzapine PS ORAL 10 MG/1 DAY Initial or Prolonged Schizophrenia Study Zotepine C Schizophrenia, Paranoid Health Biperiden C Type Professional Flunitrazepam C Other Brotizolam C Timiperone C Alprazolam C Date:04/22/03ISR Number: 4100172-2Report Type:Expedited (15-DaCompany Report #JP_030400666 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Paxil (Paroxetine Representative Hydrochloride) C Other Miradol (Sulpiride) C Date:04/22/03ISR Number: 4100178-3Report Type:Expedited (15-DaCompany Report #GBS030412952 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Foreign Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 20 MG/ Other Epilim Chrono (Valproate Sodium) C Diazepam C 24-Jun-2005 12:19 PM Page: 2261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/03ISR Number: 4100179-5Report Type:Expedited (15-DaCompany Report #JP_030400730 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Anuria Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Company Akineton (Biperiden Blood Creatine Representative Hydrochloride) C Phosphokinase Other Vegetamin A C Blood Creatinine Depas (Etizolam) C Blood Pressure Wintermin Blood Urea (Chlorpromazine Blood Uric Acid Hydrochloride) C C-Reactive Protein Thyradin S Dialysis (Levothyroxine Oxygen Saturation Sodium) C Decreased Alinamin F Platelet Count (Fursultiamine) C Pyrexia Magnesium Oxide C Urinary Retention Yodel (Senna) C White Blood Cell Count Date:04/22/03ISR Number: 4100283-1Report Type:Expedited (15-DaCompany Report #USA030433225 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Respiratory Failure Professional (Olanzapine) Company (Olanzapine) PS 35 MG/DAY 2 YR Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 60 MG/DAY Date:04/22/03ISR Number: 4100284-3Report Type:Expedited (15-DaCompany Report #USA030433250 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Road Traffic Accident Professional (Olanzapine) (Olanzapine) PS 2.5 MG/DAY Fluoxetine-Oral (Fluoxetine) (Fluoxetine Hydrochlor SS 20 MG/DAY Klonopin (Clonazepam) C Trazodone C Periactin (Cyproheptadine Hydrochloride) C Date:04/22/03ISR Number: 4100288-0Report Type:Expedited (15-DaCompany Report #USA030433774 Age:34 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Health Zyprexa Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS 20 MG/DAY Date:04/22/03ISR Number: 4100293-4Report Type:Expedited (15-DaCompany Report #USA030433767 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Zyprexa Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS 35 MG/DAY 1 YR Date:04/22/03ISR Number: 4100535-5Report Type:Expedited (15-DaCompany Report #US_030493932 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS 50 MG/DAY Professional Company Representative Date:04/22/03ISR Number: 4100861-XReport Type:Expedited (15-DaCompany Report #USA030433494 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 500 MG Representative Date:04/22/03ISR Number: 4100863-3Report Type:Expedited (15-DaCompany Report #USA030433336 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Other Hepatotoxicity Professional (Olanzapine) Liver Function Test Company (Olanzapine) PS Abnormal Representative Date:04/22/03ISR Number: 4100865-7Report Type:Expedited (15-DaCompany Report #USA030434067 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/03ISR Number: 4100866-9Report Type:Expedited (15-DaCompany Report #US_030493871 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Maternal Drugs Affecting Health Zyprexa-Oral Initial or Prolonged Foetus Professional (Olanzapine) Neonatal Respiratory Company (Olanzapine) PS Distress Syndrome Representative Effexor (Venlafaxine Pre-Eclampsia Hydrochloride) C Pregnancy Depakote (Valproate Premature Baby Semisodium) C Seroquel C Date:04/23/03ISR Number: 4097620-3Report Type:Direct Company Report #CTU 191516 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Zyprexa-Lilly PS Lilly ORAL 20MG Q DAY PO 4 MON Initial or Prolonged Dehydration Geodon-Pfizer SS Pfizer ORAL 60MG BID PO 4 MON Diabetes Mellitus Depakote C Hyperosmolar State Pancreatitis Date:04/23/03ISR Number: 4101488-6Report Type:Expedited (15-DaCompany Report #JP_030300564 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Olanzapine-Oral Infarction Study (Olanzapine) PS 10 MG DAY Asthenia Health Mercazole Depressed Level Of Professional (Thiamazole) C Consciousness Other Limas (Lithium Gait Disturbance Carbonate) C Akineton (Biperiden Hydrochloride) C Barnetil (Sultopride) C Vegetamin B C Rhythmy (Rilmazafone) C Gatifloxacin C Date:04/23/03ISR Number: 4102024-0Report Type:Expedited (15-DaCompany Report #JP_030300531 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Triglycerides Foreign Olanzapine-Oral Increased Study (Olanzapine) PS 10 MG DAY Condition Aggravated Health Risperdal Dyskinesia Professional (Risperidone) C Hyperlipidaemia Other Tasmolin (Biperiden) C Weight Increased 24-Jun-2005 12:19 PM Page: 2264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/03ISR Number: 4102027-6Report Type:Expedited (15-DaCompany Report #DE_030411064 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticholinergic Syndrome Foreign Olanzapine-Oral Condition Aggravated Literature (Olanzapine) PS 20 MG/DAY Drug Interaction Health Clozapine C Drug Toxicity Professional Digitoxin C Electroencephalogram Other Atenolol C Abnormal Glimepiride C Hepatic Steatosis Phenprocoumon C Mental Disorder Due To A General Medical Condition Overdose Renal Impairment Date:04/23/03ISR Number: 4102030-6Report Type:Expedited (15-DaCompany Report #EWC030334389 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa-Oral Initial or Prolonged Blood Triglycerides Consumer (Olanzapine) Other Increased Health (Olanzapine) PS 15 MG Dehydration Professional Metformin C Diabetes Mellitus Other Non-Insulin-Dependent Fluid Retention Haemoglobin Increased Hepatic Steatosis Hepatitis Ketoacidosis Nervousness Pancreatitis Schizophrenia White Blood Cell Count Increased Date:04/23/03ISR Number: 4102033-1Report Type:Expedited (15-DaCompany Report #GBS030212580 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Zyprexa PS Initial or Prolonged Health Carbamazepine C Professional Lustral (Sertraline Other Hydrochloride) C Date:04/23/03ISR Number: 4102034-3Report Type:Expedited (15-DaCompany Report #JP_030300513 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS ORAL 10 MG/DAY Initial or Prolonged Hyperammonaemia Health Valerin (Valproate Other Irritability Professional Sodium) C Social Avoidant Behaviour Company Pursennid (Senna Representative Leaf) C Other Magnesium Oxide C Risperidone C 24-Jun-2005 12:19 PM Page: 2265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/03ISR Number: 4102035-5Report Type:Expedited (15-DaCompany Report #JP_030200376 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Zyprexa PS ORAL 2.5 MG/DAY Health Contomin Professional (Chlorpromazine Company Hydrochloride) C Representative Flumezin Other (Fluphenazine) C Tasmolin (Biperiden) C Voltaren (Diclofenac Sodium) C Pursennid (Senna Leaf) C Serenace (Haloperidol) C Date:04/23/03ISR Number: 4102188-9Report Type:Expedited (15-DaCompany Report #HQWYE689415APR03 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Health Effexor Xr Neutropenia Professional (Venlafaxine Hydrochloride, Capsule, PS ORAL ORAL Targocid (Teicoplanin,) SS Valproate Sodium (Valproate Sodium),) SS Zyprexa (Olanzapine,) SS Warfarin C Date:04/24/03ISR Number: 4100232-6Report Type:Direct Company Report #CTU 191615 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphemia Strattera Lethargy (Atomoxetine Somnolence Hydrochloride) PS 18 MG/IN THE MORNING Zyprexa-Oral (Olanzapine) (Olanzapine) SS 7.5 MG/IN THE EVENING Date:04/24/03ISR Number: 4100537-9Report Type:Direct Company Report #CTU 191565 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Olanzapine 10 Mg Eli Hospitalization - Consciousness Lilly PS Eli Lilly ORAL 10 MG QD ORAL Initial or Prolonged Diabetic Ketoacidosis Valproic Acid C Hctz C Paroxetine C Kcl C Rabeprizole C Nifedipine C 24-Jun-2005 12:19 PM Page: 2266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonidine C Date:04/25/03ISR Number: 4100905-5Report Type:Direct Company Report #CTU 191638 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Olanzapine 5 Mg PS ORAL 5 MG QD PO Initial or Prolonged Syndrome Date:04/25/03ISR Number: 4103119-8Report Type:Expedited (15-DaCompany Report #2003016395 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Gabapentin Drug Level Increased Health (Gabapentin) PS ORAL ORAL Professional Valproic Acid (Valproic Acid) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL All Other Therapeutic Products SS ORAL ORAL Date:04/25/03ISR Number: 4103212-XReport Type:Expedited (15-DaCompany Report #2003016566 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Literature Lithane (Lithium) PS ORAL ORAL Health Olanzapine Professional (Olanzapine) SS ORAL ORAL Date:04/25/03ISR Number: 4117303-0Report Type:Periodic Company Report #NSADSS2002011114 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Literature Ultram (50 Mg Initial or Prolonged Health Tablet) (Tramadol Professional Hydrochloride) PS ORAL 150 MG, DAILY; ORAL Mirtazapine (Mirtazapine) SS UNKNOWN 45 MG, DAILY; UNKNOWN Olanzapine (Olanzapine) SS UNKNOWN 10 MG, DAILY; UNKNOWN Date:04/28/03ISR Number: 4104123-6Report Type:Expedited (15-DaCompany Report #2002-10-2453 Age:44 YR Gender:Female I/FU:F Outcome PT Disability Abdominal Pain Upper Other Bronchitis Chest Pain Conversion Disorder Convulsion Disturbance In Attention Drug Interaction 24-Jun-2005 12:19 PM Page: 2267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyskinesia Dysphagia Dysphonia Report Source Product Role Manufacturer Route Dose Duration Fatigue Other Trilafon Head Discomfort (Perphenazine) Headache Tablets PS ORAL 2 MG HS ORAL Mastitis Zyprexa (Olanzapine) Muscle Spasms Tablets SS ORAL ORAL Nausea Trazodone SS 50 MG HS Neck Pain Prozac SS 30-10 MG QD Neuralgia Caffeine SS Reading Disorder Lithium SS Respiratory Disorder ... C Speech Disorder Indocin C Tardive Dyskinesia Ativan C Throat Tightness Multivitamins C Vomiting Flexeril C Weight Decreased ... C ... C Vicodin C ... C ... C Date:04/29/03ISR Number: 4104625-2Report Type:Direct Company Report #CTU 191916 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Zyprexa 20mg /10mg Pain 7.5mg/2.5mg PS 1 TABLET AT Skin Disorder BEDTIME Date:04/30/03ISR Number: 4104788-9Report Type:Expedited (15-DaCompany Report #JP_030300538 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening C-Reactive Protein Foreign Zyprexa-Oral Other Increased Health (Olanzapine) Depressed Level Of Professional (Olanzapine) PS 420 MG/1 DAY Consciousness Company Intentional Misuse Representative Suicide Attempt Other Date:04/30/03ISR Number: 4104798-1Report Type:Expedited (15-DaCompany Report #EWC030434578 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Olanzapine-Oral Consciousness Health (Olanzapine) PS 2.5 MG/DAY Respiratory Disorder Professional Dipiperon Somnolence Other (Pipamperone) C Nitrazepam C 24-Jun-2005 12:19 PM Page: 2268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4104804-4Report Type:Expedited (15-DaCompany Report #FR_030402299 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Other Actiskenan (Morphine Sulfate) C Mopral (Omeprazole) C Contramal (Tramadol Hydrochloride) C Xanax (Alprazolam) C Fraxiparine (Heparin-Fraction, Calcium Salt) C Date:04/30/03ISR Number: 4104806-8Report Type:Expedited (15-DaCompany Report #EWC030434640 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa-Oral Hyperammonaemia Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Largactil (Chlorpromazine Hydrochloride) C Rivotril (Clonazepam) C Date:04/30/03ISR Number: 4104808-1Report Type:Expedited (15-DaCompany Report #GBS030412991 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Company Representative Other Date:04/30/03ISR Number: 4104883-4Report Type:Expedited (15-DaCompany Report #US_030393174 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Olanzapine-Oral Initial or Prolonged Intervertebral Disc Study (Olanzapine) PS 20 MG/DAY Protrusion Health Obesity Professional Other Date:04/30/03ISR Number: 4104886-XReport Type:Expedited (15-DaCompany Report #FR_030302176 Age:1 DY Gender: I/FU:F Outcome PT Other Caesarean Section Drug Withdrawal Syndrome Neonatal 24-Jun-2005 12:19 PM Page: 2269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dystonia Gastrooesophageal Reflux Disease Report Source Product Role Manufacturer Route Dose Duration Maternal Drugs Affecting Foreign Zyprexa-Oral Foetus Health (Olanzapine) Neonatal Disorder Professional (Olanzapine) PS Tremor Neonatal Other Date:04/30/03ISR Number: 4104889-5Report Type:Expedited (15-DaCompany Report #US_021189448 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Olanzapine-Oral Initial or Prolonged Gastric Mucosal Lesion Study (Olanzapine) PS 20 MG DAY Haematemesis Health Wintermin Hepatic Cirrhosis Professional (Chlorpromazine Hepatic Function Abnormal Other Hydrochloride) C Hypoglycaemia Linton (Haloperidol) C Hypoproteinaemia Tasmolin (Biperiden) C Prurigo Pantosin White Blood Cell Count (Pantethine) C Increased Hirnamin (Levomepromazine) C Lendormin (Brotizolam) C Halcion (Triazolam) C Magnesium Oxide C Pursennid (Senna Leaf) C Sodium Picosulfate C Lexin (Carbamazepine) C Dogmatyl (Sulpiride) C Date:04/30/03ISR Number: 4104893-7Report Type:Expedited (15-DaCompany Report #JP_030300503 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Drug Ineffective Health (Olanzapine) Drug Level Increased Professional (Olanzapine) PS 20 MG/DAY Hyperammonaemia Company Levotomin Mood Altered Representative (Levomepromazine Other Maleate) C Valerin (Valproate Sodium) C Thyradin S (Levothyroxine Sodium) C Pursennid (Senna Leaf) C Bromperidol C 24-Jun-2005 12:19 PM Page: 2270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4104895-0Report Type:Expedited (15-DaCompany Report #JP_030300476 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Zyprexa-Oral Blood Glucose Decreased Study (Olanzapine) Condition Aggravated Health (Olanzapine) PS 10 MG/DAY Hypercholesterolaemia Professional Levotomin Nervous System Disorder Other (Levomepromazine Neutrophil Count Maleate) C Decreased Risperdal Pallor (Risperidone) C Psychogenic Pain Disorder Emilace Shock (Nemonapride) C Sudden Death Tegretol (Carbamazepine) C Epirenat (Valproate Sodium) C Excegran (Zonisamide) C Rohypnol (Flunitrazepam) C Doral (Quazepam) C Laxoberon (Sodium Picosulfate) C Date:04/30/03ISR Number: 4105111-6Report Type:Direct Company Report #CU 192008 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bladder Disorder Depakote 125 Mg Hospitalization - Cardiac Disorder (Lilly) PS Lilly ORAL 125 MG, DAILY Initial or Prolonged Clumsiness X 1 ORAL 3 YR Disability Coordination Abnormal Xyprexa 15 Mg Abbott SS Abbott ORAL 15 MG, DAILY Other Facial Paresis X 1, ORAL 3 YR Required Gastrointestinal Disorder Intervention to Lethargy Prevent Permanent Mental Impairment Impairment/Damage Migraine Myotonia Respiratory Failure Speech Disorder Visual Acuity Reduced Weight Increased Date:04/30/03ISR Number: 4105833-7Report Type:Expedited (15-DaCompany Report #US-030494042 Age:63 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased Other Blood Osmolarity Increased Blood Potassium Increased Blood Sodium Increased Blood Urea Increased Confusional State Culture Urine Positive Cystitis Dehydration 24-Jun-2005 12:19 PM Page: 2271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Escherichia Infection Heart Rate Increased Hypotension Report Source Product Role Manufacturer Route Dose Duration Mental Status Changes Literature Olanzapine-Oral Nephrogenic Diabetes Health (Olanzapine) PS 5 MG/DAY Insipidus Professional Aspirin Enteric Pathogen Resistance Coated Polydipsia (Acetylsalicylic Urosepsis Acid) C White Blood Cell Count Metformin C Increased Valproic Acid C Furosemide C Date:04/30/03ISR Number: 4105836-2Report Type:Expedited (15-DaCompany Report #US_030494055 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Literature Olanzapine-Oral Hospitalization - Diarrhoea Health (Olanzapine) PS Initial or Prolonged Sepsis Professional Paroxetine C Toxic Epidermal Temazapam C Necrolysis Tramadol C Terbinafine C Date:04/30/03ISR Number: 4105839-8Report Type:Expedited (15-DaCompany Report #USA020921570 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Transient Consumer Zyprexa-Oral Diarrhoea (Olanzapine) Migraine With Aura (Olanzapine) PS 5 MG/DAY Mouth Ulceration Lithium C Photopsia Lexapro Treatment Noncompliance (Escitalopram) C Weight Increased Depakote (Valproate Semisodium) C Date:04/30/03ISR Number: 4105881-7Report Type:Expedited (15-DaCompany Report #USA030434750 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Toxicologic Test Abnormal Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Oxycodone C Date:04/30/03ISR Number: 4105884-2Report Type:Expedited (15-DaCompany Report #USA030434452 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4105887-8Report Type:Expedited (15-DaCompany Report #US_030393705 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Zyprexa Professional Zydis-Dispersible (Olanzapine) (Olanzapine) PS 5 MG 1 DAY Date:04/30/03ISR Number: 4105889-1Report Type:Expedited (15-DaCompany Report #US_030494111 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Other Zyprexa-Oral Respiratory Arrest (Olanzapine) (Olanzapine) PS Date:04/30/03ISR Number: 4105891-XReport Type:Expedited (15-DaCompany Report #US_030494123 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Consumer Zyprexa-Oral Other Cardiac Arrest (Olanzapine) Coma (Olanzapine) PS Date:04/30/03ISR Number: 4106112-4Report Type:Expedited (15-DaCompany Report #USA030433948 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Other (Olanzapine) PS 10 MG/AT BEDTIME Amantadine C Depakote (Valproate Semisodium) C Lithium C Date:04/30/03ISR Number: 4106114-8Report Type:Expedited (15-DaCompany Report #USA030434201 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa-Oral Initial or Prolonged Consciousness Professional (Olanzapine) Other Tachycardia Company (Olanzapine) PS 440 MG/ONCE Tremor Representative Weight Increased Date:04/30/03ISR Number: 4106116-1Report Type:Expedited (15-DaCompany Report #USA030434382 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Zyprexa-Oral Initial or Prolonged Coma Professional (Olanzapine) Other Neuroleptic Malignant Company (Olanzapine) PS 1 YR Syndrome Representative 24-Jun-2005 12:19 PM Page: 2273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4106505-5Report Type:Expedited (15-DaCompany Report #USA030434001 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Strattera Hospitalization - Drug Interaction Professional (Atomoxetine Initial or Prolonged Dysphagia Hydrochloride) PS 25 MG/DAY Lethargy Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Paxil Cr C Ritalin La (Methylphenidate Hydrochloride) C Date:04/30/03ISR Number: 4106506-7Report Type:Expedited (15-DaCompany Report #USA030434119 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Strattera Initial or Prolonged Professional (Atomoxetine Company Hydrochloride) PS 18 MG Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS Depakote (Valproate Semisodium) C Date:04/30/03ISR Number: 4106767-4Report Type:Expedited (15-DaCompany Report #USA030433966 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Screen Positive Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 35 MG/DAY Cogentin (Benzatropine Mesilate) C Date:05/02/03ISR Number: 4106927-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01492 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Foreign Carbamazepine Drug Interaction Health (Carbamazepine) Restlessness Professional Unknown PS ORAL 300MG/DAY, Other ORAL Olanzapine (Olanzapine) SS ORAL 12.5 MG/DAY, ORAL Mirtazapine (Mirtazapine) C Aspirine C Simvastatin C 24-Jun-2005 12:19 PM Page: 2274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/03ISR Number: 4105642-9Report Type:Direct Company Report #CTU 192300 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glycosylated Haemoglobin Olanzapine 10mg Increased (Lilly) PS Lilly ORAL 10 MG PO QHS Hyperglycaemia Lisinopril C Carbamazepine C Multivitamin C Ibuprofen C Date:05/05/03ISR Number: 4105703-4Report Type:Direct Company Report #CTU 192237 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa 15mg Eli Hospitalization - Diabetic Ketoacidosis Lilly PS Eli Lilly ORAL 15MG DAILY Initial or Prolonged ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:05/06/03ISR Number: 4108456-9Report Type:Expedited (15-DaCompany Report #US_030494111 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Other Zyprexa Respiratory Arrest (Olanzapine) PS Date:05/06/03ISR Number: 4108550-2Report Type:Expedited (15-DaCompany Report #USA030434978 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cyanosis Health Strattera Dyspnoea Professional (Atomoxetine Syncope Vasovagal Hydrochloride) PS 25 MG/DAY 18 DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Tenex (Guanfacine Hydrochloride) C Date:05/06/03ISR Number: 4108581-2Report Type:Expedited (15-DaCompany Report #GBS030413027 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa-Oral Overdose Health (Olanzapine) Toxicologic Test Abnormal Professional (Olanzapine) PS Company Zopiclone C Representative Other 24-Jun-2005 12:19 PM Page: 2275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/03ISR Number: 4108593-9Report Type:Expedited (15-DaCompany Report #JP_030400776 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Depakene (Valproate Representative Sodium) C Other Rohypnol (Flunitrazepam) C Uniphyl (Theophylline) C Perdipin La (Nicardipine Hydrochloride) C Date:05/06/03ISR Number: 4108594-0Report Type:Expedited (15-DaCompany Report #GBS030412919 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zyprexa-Oral Initial or Prolonged Glasgow Coma Scale Health (Olanzapine) Abnormal Professional (Olanzapine) PS 120 MG/DAY Intentional Misuse Other Lithium C Suicidal Ideation Paroxetine C Suicide Attempt Painkillers C Toxicologic Test Abnormal Hormone Replacement Therapy C Cystrin (Oxybutynin) C Date:05/06/03ISR Number: 4108595-2Report Type:Expedited (15-DaCompany Report #EWC030434661 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Foreign Zyprexa-Oral Initial or Prolonged Feeding Problem In Health (Olanzapine) Newborn Professional (Olanzapine) PS Maternal Drugs Affecting Other Foetus Neonatal Disorder Pregnancy Somnolence Neonatal Date:05/06/03ISR Number: 4108596-4Report Type:Expedited (15-DaCompany Report #EWC030434669 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa-Oral Disability Depression Health (Olanzapine) Dizziness Professional (Olanzapine) PS 15 MG/DAY Fall Company Prozac (Fluoxetine Oral Intake Reduced Representative Hydrochloride) C Psychomotor Hyperactivity Other Psychotic Disorder Shock 24-Jun-2005 12:19 PM Page: 2276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/03ISR Number: 4108825-7Report Type:Expedited (15-DaCompany Report #US_030494280 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Zyprexa-Oral (Olanazapine) (Olanazapine) PS Date:05/06/03ISR Number: 4108826-9Report Type:Expedited (15-DaCompany Report #USA030434903 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Aggression (Olanazapine) Other Bladder Cancer (Olanazapine) PS Dry Mouth Morphine C Prostatectomy Screaming Speech Disorder Date:05/08/03ISR Number: 4108896-8Report Type:Direct Company Report #USP 081103 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly Zyrtec SS Pfizer Date:05/08/03ISR Number: 4109254-2Report Type:Expedited (15-DaCompany Report #USA030331875 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Intracranial Health Zyprexa-Oral Initial or Prolonged Hypertension Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 5 MG/DAY 1 YR Representative Prozac (Fluoxetine Hydrochloride) C Xanax (Alprazolam) C Date:05/08/03ISR Number: 4109271-2Report Type:Expedited (15-DaCompany Report #USA030331015 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Zyprexa-Oral Hospitalization - Cough Professional (Olanzapine) Initial or Prolonged Hypotonia (Olanzapine) PS 10 MG/3 DAY 3 DAY Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Valium (Diazepam) C Date:05/08/03ISR Number: 4109274-8Report Type:Expedited (15-DaCompany Report #US_020988011 Age:63 YR Gender:Male I/FU:F Outcome PT Death Cardiac Failure Other Congestive 24-Jun-2005 12:19 PM Page: 2277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Catheter Site Haemorrhage Choreoathetosis Coma Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa-Oral Coordination Abnormal Professional (Olanzapine) Dysarthria (Olanzapine) PS 750 MG Dyskinesia Lithium C Electroencephalogram Terazosin C Abnormal Rabeprazole C Extensor Plantar Response Methocarbamol C Gait Disturbance Thiamine C Grimacing Ibuprofen C Haemorrhage Subcutaneous Heart Rate Increased Hyperreflexia Hypoxia Lethargy Nervous System Disorder Nuclear Magnetic Resonance Imaging Brain Abnormal Nystagmus Overdose Pathogen Resistance Pneumonia Restlessness Salivary Hypersecretion Somnolence Speech Disorder Status Epilepticus Ventricular Tachycardia Date:05/08/03ISR Number: 4109276-1Report Type:Expedited (15-DaCompany Report #US_001153999 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Overdose Professional (Olanzapine) (Olanzapine) PS 150 MG/DAY Ativan (Lorazepam) C Ibuprofen C Vitamin E C Paroxetine C Date:05/08/03ISR Number: 4109332-8Report Type:Expedited (15-DaCompany Report #JP_030300533 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Failure Foreign Olanzapine-Oral Disseminated Study (Olanzapine) PS 10 MG DAY Intravascular Coagulation Health Lullan (Lullan) C Pneumonia Professional Tasmolin (Biperiden) C Pulmonary Alveolar Other Benzalin Haemorrhage (Nitrazepam) C Pursennid (Senna Leaf) C 24-Jun-2005 12:19 PM Page: 2278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/03ISR Number: 4109356-0Report Type:Expedited (15-DaCompany Report #JP_030300528 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Increased Study (Olanzapine) Aspartate Health (Olanzapine) PS 10 MG/1 DAY Aminotransferase Professional Serenace Increased Other (Haloperidol) C Blood Lactate Contomin Dehydrogenase Increased (Chlorpromazine) C Cardio-Respiratory Arrest Pyrethia (Promethazine Hydrochloride) C Myslee (Zolpidem Tartrate) C Lendormin (Brotizolam) C Doral (Quazepam) C Halcion (Triazolam) C Date:05/08/03ISR Number: 4109421-8Report Type:Expedited (15-DaCompany Report #JP_030400730 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa-Oral Aspartate Health (Olanzapine) Aminotransferase Professional (Olanzapine) PS 10 MG/DAY Blood Creatinine Company Vegetamin A C Increased Representative Depas (Etizolam) C Blood Pressure Systolic Other Wintermin Decreased (Chlorpromazine Blood Urea Increased Hydrochloride) C C-Reactive Protein Thyradin S Liver Disorder (Levothyroxine Neuroleptic Malignant Sodium) C Syndrome Alinamin F Oliguria (Fursultiamine) C Pancytopenia Magnesium Oxide C Renal Disorder Yodel (Senna) C Staphylococcal Infection Urinary Retention Date:05/08/03ISR Number: 4109466-8Report Type:Expedited (15-DaCompany Report #JP_030300520 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Auricular Swelling Foreign Zyprexa-Oral Initial or Prolonged Deafness Neurosensory Health (Olanzapine) Dizziness Professional (Olanzapine) PS 10 MG/DAY Nausea Company Palgin C Sudden Hearing Loss Representative Tinnitus Other Vertigo 24-Jun-2005 12:19 PM Page: 2279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/03ISR Number: 4109477-2Report Type:Expedited (15-DaCompany Report #GBS030112483 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Olanzapine Initial or Prolonged Health Professional (Olanzapine) PS ORAL 20 MG/1 DAY Other Chlorpromazine C Risperdal C Date:05/08/03ISR Number: 4109479-6Report Type:Expedited (15-DaCompany Report #GBS030312744 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa PS ORAL 48 DSG Hospitalization - Renal Failure Health FORM/DAY Initial or Prolonged Somnolence Professional Anadin Extra C Suicidal Ideation Paroxetine C Weight Increased Naltrexone C Date:05/08/03ISR Number: 4109824-1Report Type:Direct Company Report #USP 081039 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Pfizer Zyprexa SS Lilly Date:05/08/03ISR Number: 4109826-5Report Type:Direct Company Report #USP 081009 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Pfizer Zyprexa SS Lilly Date:05/09/03ISR Number: 4110545-XReport Type:Expedited (15-DaCompany Report #2002-10-2453 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Bronchitis Initial or Prolonged Chest Pain Disability Conversion Disorder Other Convulsion Disturbance In Attention Drug Interaction Dyskinesia Dysphagia Dystonia Fatigue Head Discomfort Headache Mastitis Menopausal Symptoms Muscle Spasms Musculoskeletal Discomfort Nausea Neuralgia Somatisation Disorder 24-Jun-2005 12:19 PM Page: 2280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Tardive Dyskinesia Vomiting Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Other Trilafon (Perphenazine) Tablets PS ORAL 2 MG HS ORAL Zyprexa (Olanzapine) Tablets SS ORAL ORAL Trazodone SS 50 MG HS Prozac SS 30-10 MG QD Caffeine SS Lithium SS Vicodin C Flexeril C Indocin C Multivitamins C Ativan C Thyroid C Date:05/12/03ISR Number: 4110860-XReport Type:Direct Company Report #CTU 192722 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Olanzapine 2.5 Mg PS ORAL 2.5 MG QD Initial or Prolonged Dizziness ORAL Hemiparesis Speech Disorder Date:05/12/03ISR Number: 4111796-0Report Type:Direct Company Report #USP 51749 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Pfizer Zyprexa SS Lilly Date:05/12/03ISR Number: 4111849-7Report Type:Direct Company Report #USP 51722 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Celexa PS Forest Pharmaceuticals Zyprexa SS Lilly Date:05/13/03ISR Number: 4111567-5Report Type:Expedited (15-DaCompany Report #EWC030434730 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Recurrence Foreign Zyprexa-Oral Ileus Health (Olanzapine) Mania Professional (Olanzapine) PS 15 MG/DAY 6 MON Company Representative Other 24-Jun-2005 12:19 PM Page: 2281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/03ISR Number: 4111568-7Report Type:Expedited (15-DaCompany Report #DE_030411195 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Gastrointestinal Disorder Consumer (Olanzapine) Genital Disorder Male Other (Olanzapine) PS Somnolence Neurocil (Levomepromazine Maleate) C Atosil(Isopromethazi ne Hydrochloride) C Insulin C Date:05/13/03ISR Number: 4111579-1Report Type:Expedited (15-DaCompany Report #GBS030413026 Age:69 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Increased Foreign Olanzapine-Oral Rhabdomyolysis Health (Olanzapine PS 5 MG/2 DAY Professional Risperidone C Other Aricept(Donepezil Hydrochloride) C Trimethoprim C Lorazepam C Date:05/13/03ISR Number: 4111580-8Report Type:Expedited (15-DaCompany Report #GBS030312782 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa -Oral Health (Olanzapine) PS 7.5 MG/DAY Professional Fluphenazine Company Decanoate C Representative Other Date:05/13/03ISR Number: 4111581-XReport Type:Expedited (15-DaCompany Report #GBS030413039 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Drowning Consumer (Olanzapine) PS 10 MG Other Risperidone C Date:05/13/03ISR Number: 4111582-1Report Type:Expedited (15-DaCompany Report #EWC030534744 Age:58 YR Gender:Male I/FU:I Outcome PT Other Agitation Akathisia Condition Aggravated Disinhibition Drug Ineffective Fall Logorrhoea Mania Movement Disorder 24-Jun-2005 12:19 PM Page: 2282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rotator Cuff Syndrome Weight Fluctuation Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG/DAY Professional Seroproam(Citalopram Other Hydrobromide) C (Lorazepam) C Quilonorm Retard(Lithium Carbonate) C Effexor (Venlafaxine Hydrochloride) C Campral (Acamprosate Calcium) C Date:05/13/03ISR Number: 4111641-3Report Type:Expedited (15-DaCompany Report #FR_030302232 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa-Oral Initial or Prolonged Bundle Branch Block Right Health (Olanzapine) Orthostatic Hypotension Professional (Olanzapine) PS 20 MG/DAY Other Solian (Amisulpride) C Tercian (Cyamemazine) C Date:05/13/03ISR Number: 4111690-5Report Type:Expedited (15-DaCompany Report #USA030435235 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Consumer Zyprexa-Oral Initial or Prolonged Dyspnoea (Olanzapine) Psychomotor Hyperactivity (Olanzapine) PS Respiratory Rate Albuterol C Increased Zyrtec (Cetirizine Skin Discolouration Hydrochloride) C Date:05/13/03ISR Number: 4111691-7Report Type:Expedited (15-DaCompany Report #USA030435215 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa-Oral Disease Recurrence Professional (Olanzapine) (Olanzapine) PS Date:05/13/03ISR Number: 4111692-9Report Type:Expedited (15-DaCompany Report #USA030435205 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Other Thrombosis Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/03ISR Number: 4111693-0Report Type:Expedited (15-DaCompany Report #USA030435341 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Lithium C Date:05/13/03ISR Number: 4111694-2Report Type:Expedited (15-DaCompany Report #USA030435345 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Maternal Drugs Affecting Health Zyprexa-Oral Foetus Professional (Olanzapine) Neural Tube Defect (Olanzapine) PS Pregnancy Date:05/13/03ISR Number: 4111697-8Report Type:Expedited (15-DaCompany Report #USA030435627 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) PS 5 MG/DAY 2 MON Company Klonopin Representative (Clonazepam) C Date:05/13/03ISR Number: 4111698-XReport Type:Expedited (15-DaCompany Report #USA030435748 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Health Zyprexa-Oral Ventricular Extrasystoles Professional (Olanzapine) (Olanzapine) PS 7.5 MG Depakote (Valproate Semisodium) C Risperidal (Risperidone) C Date:05/13/03ISR Number: 4111699-1Report Type:Expedited (15-DaCompany Report #USA030435794 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardio-Respiratory Arrest Health Zyprexa-Oral Syncope Professional (Olanzapine) Company (Olanzapine) PS 6 MON Representative Antihypertensive C Date:05/13/03ISR Number: 4111800-XReport Type:Expedited (15-DaCompany Report #USA020616863 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Zypexa-Oral Diabetes Mellitus (Olanzapine) Pancreatic Necrosis (Olanzapine) PS UNKNOWN UNK Glyburide C 24-Jun-2005 12:19 PM Page: 2284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/03ISR Number: 4112776-1Report Type:Direct Company Report #CTU 192857 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Zyprexa 20mg Lilly PS Lilly ORAL 20MG BEDTIME Intervention to ORAL Prevent Permanent Lipitor C Impairment/Damage Date:05/14/03ISR Number: 4113062-6Report Type:Direct Company Report #CTU 192900 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Trazodone PS ORAL 100MG QHS Initial or Prolonged Dry Mouth ORAL Electrocardiogram Qt Olanzapine 7.5mg SS ORAL 7.5MG 2QD Prolonged ORAL Fatigue Hallucination, Auditory Overdose Tachycardia Tremor Date:05/14/03ISR Number: 4113196-6Report Type:Direct Company Report #CTU 192918 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Olanzapine 5mg Initial or Prolonged Coma Lilly PS Lilly ORAL 5MG QD ORAL Grand Mal Convulsion Pneumonia Date:05/14/03ISR Number: 4113283-2Report Type:Direct Company Report #CTU 192952 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Olanzapine 10mg PS ORAL 10MG QPM PO Hospitalization - Asthenia Olanzapine 5 Mg SS ORAL 5 MG QAM PO Initial or Prolonged Dizziness Fall Memory Impairment Polydipsia Polyuria Syncope Urinary Incontinence Date:05/14/03ISR Number: 4113778-1Report Type:Direct Company Report #CTU 192998 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zyprexa 15mg Eli Lilly PS Eli Lilly ORAL 10MG INITALLY TO 15MG OD ORAL 24-Jun-2005 12:19 PM Page: 2285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/03ISR Number: 4109977-5Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0299312A Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumopathy Zovirax PS Glaxosmithkline UNKNOWN 1UNIT Four Initial or Prolonged times per day Vectarion SS ORAL 1UNIT Three times per day Oxeol SS ORAL 1UNIT Per day Zyprexa SS ORAL 1UNIT Per day Aricept SS ORAL 1UNIT Per day Fraxiparine SS SUBCUTANEOUS 7500UNIT Per day Date:05/15/03ISR Number: 4113086-9Report Type:Expedited (15-DaCompany Report #2002-10-2453 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Other Trilafon Initial or Prolonged Bronchitis (Perphenazine) Disability Chest Pain Tablets PS ORAL 2 -6 MG QD Other Convulsion ORAL Disturbance In Attention Zyprexa (Olanzapine) Drug Interaction Tablets SS ORAL ORAL Dysphagia Trazodone SS 50 MG HS Dysphonia Prozac SS 30-10 MG QD Dyspnoea Caffeine SS Eye Movement Disorder Lithium SS Fatigue Vicodin C Headache Flexeril C Mastitis Indocin C Menopausal Symptoms Multivitamins C Muscle Spasms Ativan C Musculoskeletal Thyroid C Discomfort Wellbutrin Nausea (Bupropion) C Neck Pain Zoloft C Reading Disorder Desipramine C Speech Disorder Effexor C Tardive Dyskinesia Depakote C Throat Tightness Nortriptyline C Vomiting Doxepin C Weight Decreased Date:05/16/03ISR Number: 4113684-2Report Type:Expedited (15-DaCompany Report #M0481-2003 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Mirtazapine PS 60 MG Initial or Prolonged Decreased Professional Olanzapine SS Circulatory Collapse Diarrhoea Loss Of Consciousness Platelet Count Decreased 24-Jun-2005 12:19 PM Page: 2286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/03ISR Number: 4114647-3Report Type:Expedited (15-DaCompany Report #EWC030534795 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 2.5 MG/DAY Aminotransferase Other Ergenyl (Valproate Increased Sodium) C Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Chromaturia Faeces Discoloured Gamma-Glutamyltransferase Increased Liver Disorder Pain Date:05/19/03ISR Number: 4114648-5Report Type:Expedited (15-DaCompany Report #EWC030534815 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Zyprexa-Oral Breast Hyperplasia Health (Olanzapine) Breast Mass Professional (Olanzapine) PS 20 MG/DAY Breast Pain Company Paroxetine C Weight Increased Representative Other Date:05/19/03ISR Number: 4114651-5Report Type:Expedited (15-DaCompany Report #CA_030505920 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Dispersible Overdose Health (Olanzapine) Professional (Olanzapine) PS 6 MON Company Representative Other Date:05/19/03ISR Number: 4114652-7Report Type:Expedited (15-DaCompany Report #DE_030511212 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Foreign Zyprexa-Oral Initial or Prolonged Idiopathic Health (Olanzapine) Thrombocytopenic Purpura Professional (Olanzapine) PS 5 MG/DAY Other Date:05/19/03ISR Number: 4115059-9Report Type:Expedited (15-DaCompany Report #USA030536535 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Zyprexa-Oral Leukopenia Professional (Olanzapine) Neutrophil Count Company (Olanzapine) PS Increased Representative Arimidex 24-Jun-2005 12:19 PM Page: 2287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Anastrozole) C Trileptal (Oxcarbazepine) C Date:05/19/03ISR Number: 4115060-5Report Type:Expedited (15-DaCompany Report #USA030536487 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:05/19/03ISR Number: 4115061-7Report Type:Expedited (15-DaCompany Report #USA030536357 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zyprexa-Oral Dehydration Professional (Olanzapine) Diabetes Mellitus Company (Olanzapine) PS 20 MG/DAY 4 MON Hyperosmolar State Representative Geodon (Ziprasidone Pancreatitis Hydrochloride) C Depakote (Valproate Semisodium) C Date:05/19/03ISR Number: 4115062-9Report Type:Expedited (15-DaCompany Report #USA030536109 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Zyprexa-Oral Other Overdose Professional (Olanzapine) PS 30 MG /AT Pulmonary Embolism BEDTIME 1 YR Vasotec (Enalapril Maleate) C Lorazepam C Oscal (Calcium Carbonate0 C Clindamycin C Date:05/19/03ISR Number: 4115063-0Report Type:Expedited (15-DaCompany Report #USA030535988 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Methadone C Depakote (Valproate Semisodium) C Date:05/19/03ISR Number: 4115064-2Report Type:Expedited (15-DaCompany Report #USA030434966 Age:12 YR Gender:Male I/FU:I Outcome PT Other Condition Aggravated Insomnia Lupus-Like Syndrome 24-Jun-2005 12:19 PM Page: 2288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY 1 WK Representative Date:05/19/03ISR Number: 4115074-5Report Type:Expedited (15-DaCompany Report #US_030594525 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Zyprexa-Oral Cardiac Failure Professional (Olanzapine) Hypoglycaemia Company (Olanzapine) PS Organ Failure Representative Trilafon (Perphenazine) C Depakote (Valproate) C Date:05/19/03ISR Number: 4115082-4Report Type:Expedited (15-DaCompany Report #USA030330823 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Health Zyprexa-Oral Leukopenia Professional (Olanzapine) Myeloid Maturation Arrest Company (Olanzapine) PS 32 MON Neutropenia Representative Chlorpromazine C Small Cell Lung Cancer Risperdal Stage Unspecified (Risperidone) C Date:05/19/03ISR Number: 4115091-5Report Type:Expedited (15-DaCompany Report #USA030126101 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 3.75 MG DAY Coumadin (Warfarin Sodium) C Date:05/19/03ISR Number: 4115135-0Report Type:Expedited (15-DaCompany Report #US_030594382 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Upper Gastrointestinal Foreign Olanzapine-Oral Haemorrhage Literature (Olanzapine) PS Health Aspirin C Professional Metformin C Other Date:05/19/03ISR Number: 4115136-2Report Type:Expedited (15-DaCompany Report #US_030594378 Age:65 YR Gender: I/FU:I Outcome PT Report Source Other Cholelithiasis Foreign Pancreatitis Acute Literature 24-Jun-2005 12:19 PM Page: 2289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS Zopiclone C Date:05/19/03ISR Number: 4115143-XReport Type:Expedited (15-DaCompany Report #FR_030302189 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Zyprexa-Oral Asthenia Health (Olanzapine) Blood Iron Decreased Professional (Olanzapine) PS 15 MG/DAY Prothrombin Time Other Xanax (Alprazolam) C Shortened Thrombocytopenia Date:05/19/03ISR Number: 4115144-1Report Type:Expedited (15-DaCompany Report #GBS030413027 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Drug Toxicity Health (Olanzapine) Overdose Professional (Olanzapine) PS Company Zopiclone C Representative Other Date:05/19/03ISR Number: 4115145-3Report Type:Expedited (15-DaCompany Report #GBS030413039 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Drowning Consumer (Olanzapine) Health (Olanzapine) PS 12.5 MG/DAY Professional Risperidone C Other Date:05/19/03ISR Number: 4115146-5Report Type:Expedited (15-DaCompany Report #FR_030302176 Age:1 DY Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apgar Score Low Foreign Zyprexa-Oral Caesarean Section Health (Olanzapine) Drug Withdrawal Syndrome Professional (Olanzapine) PS Gastrooesophageal Reflux Other Disease Maternal Drugs Affecting Foetus 24-Jun-2005 12:19 PM Page: 2290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/03ISR Number: 4115147-7Report Type:Expedited (15-DaCompany Report #JP_030500880 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Overdose Other (Olanzapine) (Olanzapine) PS Lexotan(Bromazepam) C Tofranil (Imipramine Hydrochloride) C Tryptanol (Amitriptyline Hydrochloride) C Mucosta (Rebamipide) C Paxil (Paroxetine Hydrochloride) C Date:05/19/03ISR Number: 4115148-9Report Type:Expedited (15-DaCompany Report #FR_030402367 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Motility Foreign Zyprexa-Oral Initial or Prolonged Disorder Health (Olanzapine) Gastrooesophageal Reflux Professional (Olanzapine) PS 7.5 MG/DAY Disease Other Deroxat(Paroxetine Hydrochloride) C Primperan (Metoclopramide) C Lepticur (Tropatepine Hydrochloride) C Exelon (Rivastigmine Tartrate) C Glucor (Acarbose) C Lipanthyl (Fenofibrate) C Date:05/19/03ISR Number: 4115164-7Report Type:Expedited (15-DaCompany Report #GBS030513079 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG/DAY Professional Diazepam C Other Zopiclone C Lorazepam C Thioridazine C Haldol Decanoate (Haloperidol Decanoate) C Co-Trimoxazole C Date:05/19/03ISR Number: 4115165-9Report Type:Expedited (15-DaCompany Report #JP_030400818 Age:41 YR Gender:Female I/FU:I Outcome PT Life-Threatening Hypertension Hospitalization - Myelocyte Count Increased Initial or Prolonged Pharyngolaryngeal Pain 24-Jun-2005 12:19 PM Page: 2291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Red Blood Cell Sedimentation Rate Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Zyprexa-Oral White Blood Cell Count Health (Olanzapine) Increased Professional (Olanzapine) PS 5 MG/DAY Other Serenace (Haloperidol) C Artane (Trihexyphenidyl Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Rohypnol (Flunitrazepam) C Date:05/19/03ISR Number: 4115176-3Report Type:Expedited (15-DaCompany Report #AU_030506228 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Consumer (Olanzapine) Body Temperature Health (Olanzapine) PS 5 MG/DAY Increased Professional Avanza (Mirtazapine) C Confusional State Other Depressed Level Of Consciousness Gastric Disorder Liver Disorder Platelet Count Decreased Renal Disorder Date:05/22/03ISR Number: 4116112-6Report Type:Expedited (15-DaCompany Report #2002-10-2453 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Bronchitis Disability Chest Pain Other Cognitive Disorder Conversion Disorder Convulsion Disturbance In Attention Drug Interaction Drug Withdrawal Syndrome Dyskinesia Dysphagia Dysphonia Emotional Disorder Fatigue Head Discomfort Headache Mastitis Memory Impairment Menopausal Symptoms Muscle Spasms Musculoskeletal Discomfort 24-Jun-2005 12:19 PM Page: 2292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Neck Pain Neuralgia Report Source Product Role Manufacturer Route Dose Duration Performance Status Other Trilafon Decreased (Perphenazine) Reading Disorder Tablets PS ORAL 2 -6 MG QD Respiratory Disorder ORAL Somatisation Disorder Zyprexa (Olanzapine) Speech Disorder Tablets SS ORAL ORAL Tardive Dyskinesia Trazodone SS 50 MG HS Throat Tightness Prozac SS 30-10 MG QD Vomiting Caffeine SS Weight Decreased Lithium SS Vicodin C Flexeril C Indocin C Multivitamins C Ativan C Thyroid Unknown C Wellbutrin (Bupropion) C Zoloft C Desipramine C Effexor C Depakote C Nortriptyline C Doxepin C Dicloxacillin C Clonazepam C Beclomethasone C Ibuprofen C Alprazolam C Cephalexin C Septran Ds (Trimethoprim/Sulfam ethoxazole) C Date:05/23/03ISR Number: 4114803-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12276796 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Buspar Tabs 10 Mg PS Bristol-Myers Squibb Hospitalization - Pulmonary Embolism Professional Company ORAL 10mg tablet- Initial or Prolonged Superinfection Lung 1.5 tabs/day Thyroid Disorder Kardegic SS ORAL Zyprexa SS ORAL 1 tablet daily. Date:05/23/03ISR Number: 4120517-7Report Type:Periodic Company Report #USA030330262 Age:54 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Anxiety Malaise Nervousness Paranoia Prescribed Overdose Tension 24-Jun-2005 12:19 PM Page: 2293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 30 MG/DAY Lithium C Prevacid C Date:05/27/03ISR Number: 4117436-9Report Type:Direct Company Report #CTU 194025 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Zyprexa PS ORAL 7.5 MG ONCE Feeling Abnormal DAILY ORAL Pollakiuria Thirst Weight Increased Date:05/27/03ISR Number: 4119126-5Report Type:Direct Company Report #CTU 193922 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delirium Olanzapine Lilly PS Lilly ORAL 10 MG QD PO Hospitalization - Hallucination Initial or Prolonged Hyperpyrexia Required Muscle Rigidity Intervention to Neuroleptic Malignant Prevent Permanent Syndrome Impairment/Damage Tachycardia Date:05/28/03ISR Number: 4118682-0Report Type:Expedited (15-DaCompany Report #2003-105038-NL Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dementia Consumer Remeron PS 7.5 MG DAILY Emotional Distress Zyprexa SS DF DAILY Hallucination Haldol SS 0.5 MG DAILY Plafix C Date:05/28/03ISR Number: 4119074-0Report Type:Expedited (15-DaCompany Report #EMADSS2003004249 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Risperdal (2 Mg Initial or Prolonged Positive Health Tablet) Rhabdomyolysis Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL; 4 MG DAILY, ORAL Zyprexa (Olanzapine) SS 15 MG, DAILY, UNKNOWN L-Thyroxin (Levothyroxine Sodium) C 24-Jun-2005 12:19 PM Page: 2294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120446-9Report Type:Periodic Company Report #USA030125416 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4120449-4Report Type:Periodic Company Report #USA030125411 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Zyprexa-Oral Initial or Prolonged Anaemia Professional (Olanzapine) Dizziness Company (Olanzapine) PS Representative Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Albuterol C Azmacort (Triamcinolone Acetonide) C Atrovent (Ipratropium Bromide) C Synthroid (Levothyroxine Sodium) C Vitamin C C Date:05/28/03ISR Number: 4120450-0Report Type:Periodic Company Report #USA021225075 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Zyprexa-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 5 MG/AT Other Representative BEDTIME Wellbutrin Sr (Bupropion Hydrochloride) C Date:05/28/03ISR Number: 4120451-2Report Type:Periodic Company Report #USA021225058 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Company Zyprexa-Oral Initial or Prolonged Coma Representative (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120454-8Report Type:Periodic Company Report #USA021224984 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4120456-1Report Type:Periodic Company Report #USA021224614 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa-Oral Initial or Prolonged Confusional State (Olanzapine) (Olanzapine) PS Date:05/28/03ISR Number: 4120459-7Report Type:Periodic Company Report #USA021224605 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Depakote (Valproate Semisodium) C Date:05/28/03ISR Number: 4120464-0Report Type:Periodic Company Report #USA021224559 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Depakote (Valproate Semisodium) C Date:05/28/03ISR Number: 4120467-6Report Type:Periodic Company Report #USA021224461 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY 2 DAY Representative Haldol (Haloperidol) C Date:05/28/03ISR Number: 4120469-XReport Type:Periodic Company Report #USA021224398 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) Tachycardia Company (Olanzapine) PS 300 MG/DAY Representative 24-Jun-2005 12:19 PM Page: 2296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120474-3Report Type:Periodic Company Report #USA030229512 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Ejaculation Disorder (Olanzapine) (Olanzapine) PS 10 MG/2 DAY Risperdal (Risperidone) C Lithobid (Lithium Carbonate) C Benzatropine C Date:05/28/03ISR Number: 4120477-9Report Type:Periodic Company Report #USA030228809 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Other Lipids Abnormal Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4120478-0Report Type:Periodic Company Report #USA030228671 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Professional (Olanzapine) Other Syndrome (Olanzapine) PS 5 MG/1 DAY White Blood Cell Count Celexa (Citalopram Increased Hydrobromide) C Aricept C Date:05/28/03ISR Number: 4120479-2Report Type:Periodic Company Report #USA030228391 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4120482-2Report Type:Periodic Company Report #USA030228323 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Blood Glucose Increased (Olanzapine) Other Diabetes Mellitus (Olanzapine) PS 20 MG/DAY Furuncle Humulin-Human Nph Pancreatitis Insulin (Rdna) Weight Increased (Human Insulin (Rd SS Temazepam C Remeron (Mirtazapine) C Trazodone C Celexa (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 2297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin (Bupropion Hydrochloride) C Date:05/28/03ISR Number: 4120483-4Report Type:Periodic Company Report #USA030227668 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Urine Ketone Body Present Professional (Olanzapine) Weight Decreased (Olanzapine) PS 10 MG/DAY 8 MON Klonopin (Clonazepam) C Date:05/28/03ISR Number: 4120486-XReport Type:Periodic Company Report #USA030126426 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa-Oral Initial or Prolonged Dementia Professional (Olanzapine) Other Hyperglycaemia Company (Olanzapine) PS 5 MG/DAY Weight Increased Representative Remeron (Mirtazapine) C Date:05/28/03ISR Number: 4120487-1Report Type:Periodic Company Report #USA030126263 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4120489-5Report Type:Periodic Company Report #USA030126212 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS Date:05/28/03ISR Number: 4120490-1Report Type:Periodic Company Report #USA030125621 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Lithium C 24-Jun-2005 12:19 PM Page: 2298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120494-9Report Type:Periodic Company Report #USA030331652 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Depakote (Valproate Semisodium) C Date:05/28/03ISR Number: 4120499-8Report Type:Periodic Company Report #USA030331592 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Other Aspartate (Olanzapine) PS 10 MG/AT Aminotransferase BEDTIME Increased Xanax (Alprazolam) C Hepatitis Liver Function Test Abnormal Pyrexia Schizophrenia Date:05/28/03ISR Number: 4120502-5Report Type:Periodic Company Report #USA030331546 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Date:05/28/03ISR Number: 4120507-4Report Type:Periodic Company Report #USA030331440 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 25 MG/DAY Representative Seroquel (Quetiapine Fumarate) C Date:05/28/03ISR Number: 4120508-6Report Type:Periodic Company Report #USA030331022 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased Other Convulsion Difficulty In Walking Disorientation Dysphagia Fall Insomnia Mental Status Changes Middle Insomnia 24-Jun-2005 12:19 PM Page: 2299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:05/28/03ISR Number: 4120513-XReport Type:Periodic Company Report #USA030330759 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 10 MG/DAY Representative Carbamazepine C Date:05/28/03ISR Number: 4120515-3Report Type:Periodic Company Report #USA030330321 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) Urinary Tract Infection (Olanzapine) PS 2.5 MG/DAY Date:05/28/03ISR Number: 4120519-0Report Type:Periodic Company Report #USA030229727 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Consumer Zyprexa-Oral Initial or Prolonged Dizziness (Olanzapine) Dyspnoea (Olanzapine) PS 7.5 MG/IN THE Feeling Abnormal EVENING Heart Rate Increased Prozac-Oral Schizoaffective Disorder (Fluoxetine) Tremor (Fluoxetine Hydrochloride) SS 30 MG/IN THE EVENING Date:05/28/03ISR Number: 4120521-9Report Type:Periodic Company Report #USA030229518 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Ejaculation Disorder (Olanzapine) (Olanzapine) PS 5 MG/DAY Klonopin (Clonazepam) C Lithonate (Lithium Cabonate) C Depakote (Valproate Semisodium) C Geodon( Ziprasidone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120524-4Report Type:Periodic Company Report #US_021189466 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Lithium Carbonate C Date:05/28/03ISR Number: 4120525-6Report Type:Periodic Company Report #US_020988349 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Zyprexa-Oral Initial or Prolonged Parkinsonism Professional (Olanzapine) Pyrexia (Olanzapine) PS Urinary Tract Infection Date:05/28/03ISR Number: 4120526-8Report Type:Periodic Company Report #USA030332633 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Other Syncope Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Norvasc (Amlodipine Besilate) C Aldactazide C Date:05/28/03ISR Number: 4120528-1Report Type:Periodic Company Report #USA030332441 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Zyprexa-Oral Initial or Prolonged Gait Disturbance Professional (Olanzapine) Hyperventilation Company (Olanzapine) PS 5 MG/DAY 1 MON Representative Date:05/28/03ISR Number: 4120530-XReport Type:Periodic Company Report #USA030332300 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Zyprexa-Oral Initial or Prolonged Overdose Professional (Olanzapine) (Olanzapine) PS 50 MG/DAY Date:05/28/03ISR Number: 4120531-1Report Type:Periodic Company Report #USA030332252 Age:26 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Glucose Fluctuation Initial or Prolonged Blood Glucose Increased Other Blood Sodium Increased Hyperglycaemic Hyperosmolar Nonketotic Syndrome Hyperkalaemia 24-Jun-2005 12:19 PM Page: 2301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Thirst Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/AT BEDTIME Multivitamin C Folate Sodium C Date:05/28/03ISR Number: 4120533-5Report Type:Periodic Company Report #USA030332235 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4120535-9Report Type:Periodic Company Report #USA030332076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa-Oral Initial or Prolonged Prescribed Overdose Professional (Olanzapine) Other Company (Olanzapine) PS 25 MG/DAY 4 YR Representative Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Haloperidol C Date:05/28/03ISR Number: 4120536-0Report Type:Periodic Company Report #USA030331854 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) Mania Company (Olanzapine) PS 5 MG/DAY Orthostatic Hypotension Representative Depakote (Valproate Sinus Bradycardia Semisodium) C .. C .. C Date:05/28/03ISR Number: 4120539-6Report Type:Periodic Company Report #USA030331656 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Strattera Initial or Prolonged Loss Of Consciousness Professional (Atomoxetine Other Tongue Disorder Company Hydrochloride) PS 2 DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120543-8Report Type:Periodic Company Report #US_991232959 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aortic Thrombosis Consumer Zyprexa Hospitalization - Dehydration Health (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Diabetic Hyperosmolar Professional Lithium C Disability Coma Valproic Acid C Other Drug Level Increased Vasotec (Enalapril Gangrene Maleate) C Hypercoagulation Clonazepam C Hyperglycaemia Niaspan (Nicotinic Nephrogenic Diabetes Acid) C Insipidus Indocin Neuroleptic Malignant (Indometacin) C Syndrome Pain In Extremity Peripheral Ischaemia Renal Impairment Weight Increased Date:05/28/03ISR Number: 4120546-3Report Type:Periodic Company Report #US_990115366 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Humalog-.(Lispro) PS 10 U/3 DAY Initial or Prolonged Diabetic Ketoacidosis Health Humulin-Human Drug Ineffective Professional Regular Insulin Movement Disorder (Rdna) (Human Pancreatic Disorder Insulin SS 6 U/3 DAY Weight Increased Humulin-Human Nph Insulin (Rdna) (Human Insulin (Rd SS Zyprexa-Oral (Olanzapine) SS ORAL 15 MG/DAY Lithium C Synthroid (Levothyroxine Sodium) C Premarin (Estrogens Conjugated) C (Clonazepam) C Lantus (Insulin Glargine) C Novolin N (Insulin Human Injection, Isophane) C Risperdal C Date:05/28/03ISR Number: 4120547-5Report Type:Periodic Company Report #US_030393705 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa Zydis Medication Error Professional (Olanzapine) PS 5 MG 1 DAY 24-Jun-2005 12:19 PM Page: 2303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120549-9Report Type:Periodic Company Report #US_030191948 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa Initial or Prolonged Professional (Olanzapine) PS Company Representative Date:05/28/03ISR Number: 4120551-7Report Type:Periodic Company Report #US_021290959 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa Initial or Prolonged Sedation Professional (Olanzapine) PS ORAL 145 MG/DAY Somnolence Company Suicide Attempt Representative Date:05/28/03ISR Number: 4120553-0Report Type:Periodic Company Report #US_021290741 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Zyprexa Initial or Prolonged Drooling Professional (Olanzapine) PS ORAL 50 MG/1 DAY Hallucination, Auditory Company Haldol (Haloperidol) C Prescribed Overdose Representative Lithium C Colace (Docusate Sodium) C Fibercon (Polycarbophil Calcium) C Lactulose C Date:05/28/03ISR Number: 4120555-4Report Type:Periodic Company Report #US_021290721 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa Initial or Prolonged Diabetic Ketoacidosis (Olanzapine) PS ORAL Other Muscle Spasms Pollakiuria Thirst Date:05/28/03ISR Number: 4120556-6Report Type:Periodic Company Report #US_021290564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa Initial or Prolonged Professional (Olanzapine) PS Company Representative 24-Jun-2005 12:19 PM Page: 2304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4120560-8Report Type:Periodic Company Report #US_021189647 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Humulin-Human Initial or Prolonged Cataract Other Insulin : 30% Depression Regular, 70% Nph PS 48 IU/2 DAY Dizziness Prozac Hand Fracture (Fluoxetine) SS Osteoporosis Zyprexa Rib Fracture (Olanzapine) SS 15 MG./DAY Somnolence Actos Suicidal Ideation "Takeda" (Pioglitazone) C Takeda Anacin C Celebrex (Celecoxib) C Salsalate C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Nitroglycerin (Glyceryl Trinitrate) C Date:05/28/03ISR Number: 4120562-1Report Type:Periodic Company Report #US_021189641 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Prozac Weekly PS 90 MG/DAY Initial or Prolonged Limb Injury Professional Zyprexa-Oral Prescribed Overdose (Olanzapine) SS ORAL 50 MG/DAY Pulmonary Embolism Tricor (Fenofibrate) C Premarin (Estrogens Conjugated) C Calcium Carbonate C Vitamin E C Date:05/28/03ISR Number: 4122654-XReport Type:Periodic Company Report #USA021022883 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa-Oral Initial or Prolonged Tardive Dyskinesia Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4122655-1Report Type:Periodic Company Report #USA021022803 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Pancreatitis Professional (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4122656-3Report Type:Periodic Company Report #USA021022802 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Propylthiouracil C Zoloft C Celebrex (Celecoxib) C Date:05/28/03ISR Number: 4122657-5Report Type:Periodic Company Report #USA021022772 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Aspartate (Olanzapine) PS 15 MG/DAY Aminotransferase Meropenem C Increased Morphine C Blood Bilirubin Increased Lorazepam C Zofran C Chlorpromazine C Date:05/28/03ISR Number: 4122658-7Report Type:Periodic Company Report #USA021022625 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ischaemic Stroke Health Zyprexa-Oral Initial or Prolonged Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Remeron (Mirtazapine) C Date:05/28/03ISR Number: 4122659-9Report Type:Periodic Company Report #USA021022483 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Zyprexa-Oral Initial or Prolonged Headache (Olanzapine) Schizophrenia (Olanzapine) PS 10 MG/DAY Weight Increased Date:05/28/03ISR Number: 4122660-5Report Type:Periodic Company Report #USA021022394 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Road Traffic Accident Professional (Olanzapine) Other Company (Olanzapine) PS 5 MG/DAY Representative Zoloft C Wellbutrin Sr C Klonopin C 24-Jun-2005 12:19 PM Page: 2306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4122661-7Report Type:Periodic Company Report #USA021022371 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Antihypertensive C Date:05/28/03ISR Number: 4122662-9Report Type:Periodic Company Report #USA021022347 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Other Company (Olanzapine) PS Representative Haldol (Haloperidol) C Date:05/28/03ISR Number: 4122663-0Report Type:Periodic Company Report #USA021022274 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Disorientation Professional (Olanzapine) Other Loss Of Consciousness Company (Olanzapine) PS 20 MG/DAY Schizophrenia Representative Risperidal Tooth Extraction (Risperidone) C Date:05/28/03ISR Number: 4122664-2Report Type:Periodic Company Report #USA021123491 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Zyprexa-Oral Initial or Prolonged Weight Increased Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/28/03ISR Number: 4122665-4Report Type:Periodic Company Report #USA021123469 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 150 MG/DAY Representative Date:05/28/03ISR Number: 4122666-6Report Type:Periodic Company Report #USA021123428 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 300 MG/DAY Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4122667-8Report Type:Periodic Company Report #USA021123297 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Zyprexa-Oral Initial or Prolonged Depressed Level Of Professional (Olanzapine) Consciousness (Olanzapine) PS 15 MG Medication Error Restlessness Date:05/28/03ISR Number: 4122668-XReport Type:Periodic Company Report #USA021123281 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Date:05/28/03ISR Number: 4122669-1Report Type:Periodic Company Report #USA021123280 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Date:05/28/03ISR Number: 4122670-8Report Type:Periodic Company Report #USA021023247 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Lithium C Date:05/28/03ISR Number: 4122671-XReport Type:Periodic Company Report #USA021023091 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Date:05/28/03ISR Number: 4122672-1Report Type:Periodic Company Report #USA021023024 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS 20 MG/DAY 24-Jun-2005 12:19 PM Page: 2308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4122673-3Report Type:Periodic Company Report #USA021023016 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa - Oral Initial or Prolonged Coma Professional (Olanzapine) (Olanzapine) PS Date:05/28/03ISR Number: 4122674-5Report Type:Periodic Company Report #USA021224361 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Health Zyprexa PS Initial or Prolonged Professional Benadryl Company (Diphenhydramine Representative Hydrochloride) C Klonopin (Clonazepam) C Clozaril (Clozapine) C Desyrel (Trazodone Hydrochloride) C Date:05/28/03ISR Number: 4122675-7Report Type:Periodic Company Report #USA021124209 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tremor Health Zyprexa PS 5 MG/DAY Initial or Prolonged Professional Sinemet C Company Representative Date:05/28/03ISR Number: 4122676-9Report Type:Periodic Company Report #USA021124171 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa PS 20 MG/DAY Professional Company Representative Date:05/28/03ISR Number: 4122677-0Report Type:Periodic Company Report #USA021124126 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Health Zyprexa PS 15 MG/DAY Initial or Prolonged Blood Glucose Increased Professional Celexa (Citalopram Blood Potassium Decreased Company Hydrobromide) C Convulsion Representative Risperdal Hyponatraemia (Risperidone) C Polydipsia Haldol Decanoate (Haloperidol Decanoate) C Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 2309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4122678-2Report Type:Periodic Company Report #USA021124124 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Health Zyprexa PS 5 MG/DAY Initial or Prolonged Overdose Professional Other Date:05/28/03ISR Number: 4122679-4Report Type:Periodic Company Report #USA021124047 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Zyprexa PS 15 MG/DAY 11 MON Initial or Prolonged Blood Glucose Decreased Humalog-.(Lispro) SS Other Blood Glucose Increased Lantus (Insulin Depression Glargine) C Diabetic Coma Wellbutrin Speech Disorder (Amfebutamone Suicide Attempt Hydrochloride) C Tremor Levothyroxine C Date:05/28/03ISR Number: 4122680-0Report Type:Periodic Company Report #USA021124045 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS 10 MG/DAY Initial or Prolonged Blood Creatine Professional Phosphokinase Increased Company Delirium Representative Intentional Misuse Tachycardia Date:05/28/03ISR Number: 4122681-2Report Type:Periodic Company Report #USA021123618 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS 5 MG/AT Initial or Prolonged Agitation Professional BEDTIME Drug Screen Positive Aspirin C Hypotension Pneumonia Syncope Date:05/28/03ISR Number: 4122682-4Report Type:Periodic Company Report #USA021123496 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa Zydis PS 10 MG/DAY Initial or Prolonged Syndrome Professional Verapamil C Other Aspirin C Hydrochlorothiazide C 24-Jun-2005 12:19 PM Page: 2310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4122683-6Report Type:Periodic Company Report #USA021123492 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa Zydis PS 20 MG/DAY 5 DAY Initial or Prolonged Syndrome Professional Haldol (Haloperidol) C Other Aspirin C Oscal (Calcium Carbonate) C Date:05/28/03ISR Number: 4122684-8Report Type:Periodic Company Report #USA021022225 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Zyprexa-Oral Initial or Prolonged Convulsion (Olanzapine) Other Difficulty In Walking (Olanzapine) PS 20 MG/DAY 5 YR Hypertension Demulen C Weight Increased Quetiapine C Date:05/28/03ISR Number: 4122685-XReport Type:Periodic Company Report #USA021022128 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Blood Creatine Professional (Olanzapine) Phosphokinase Increased (Olanzapine) PS 20 MG/DAY Convulsion Hyponatraemia Liver Function Test Abnormal Polydipsia Tachycardia Date:05/28/03ISR Number: 4122686-1Report Type:Periodic Company Report #USA020921541 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardioactive Drug Level Health Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Professional (Olanzapine) Syndrome Company (Olanzapine) PS 10 MG/DAY Pyelonephritis Representative Risperdal (Risperidone) C Aricept (Donepezil Hydrochloride) C Lanoxin (Digoxin) C Questran (Colestyramine) C Aspirin C Calcium C Acetaminophen C Nitroglycerin (Glyceryl Trinitrate) C Zantac (Ranitidine Hydrochloride) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 2311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4122687-3Report Type:Periodic Company Report #USA020920708 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:05/28/03ISR Number: 4122688-5Report Type:Periodic Company Report #USA020819293 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Consumer Zyprexa-Oral Initial or Prolonged Bronchospasm (Olanzapine) Chest Discomfort (Olanzapine) PS 5 MG/2 DAY Chest Pain Kadian (Morphine Conversion Disorder Sulfate) C Depression Vicodin C Dissociative Disorder Neurontin Electrocardiogram (Gabapentin) C Abnormal Inderal La (Propanol Fatigue Hydrochloride) C Feeling Cold Proventil Hypertension (Salbutamol) C Initial Insomnia Flovent (Fluticasone Paraesthesia Propionate) C Thinking Abnormal Tremor Upper Respiratory Tract Inflammation Date:05/28/03ISR Number: 4122689-7Report Type:Periodic Company Report #USA020718602 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Fall Company (Olanzapine) PS 20 MG/DAY Glycosylated Haemoglobin Representative Haldol Decanoate Increased (Haloperidol Decanoate) C Cogentin (Benazatropine Mesilate) C Depakote (Valproate Semisodium) C Date:05/29/03ISR Number: 4118540-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0409645A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Paxil Cr PS Glaxosmithkline ORAL Hallucination Zyprexa SS Hallucination, Auditory Metadate SS Nightmare Self Mutilation 24-Jun-2005 12:19 PM Page: 2312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4118546-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0300130A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Paroxetine PS Glaxosmithkline 20MG At night Increased Olanzapine SS 10MG Twice Haemorrhage per day Hypotension Mental Status Changes Muscle Rigidity Tremor Date:05/29/03ISR Number: 4119401-4Report Type:Direct Company Report #CTU 194234 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Weight Increased Zyprexa PS 10-20 MG Intervention to DAILY Prevent Permanent Impairment/Damage Date:05/29/03ISR Number: 4119402-6Report Type:Direct Company Report #CTU 194239 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Zyprexa 5-15 Mg Intervention to Abnormal Daily PS 5-15 MG "O" Prevent Permanent Diabetes Mellitus Lamithal C Impairment/Damage Insulin-Dependent Effexor C Date:05/29/03ISR Number: 4119403-8Report Type:Direct Company Report #CTU 194240 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Zyprexa PS 5-20 MG Hyperlipidaemia Effexor Xl C Date:05/29/03ISR Number: 4119574-3Report Type:Direct Company Report #CTU 194308 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Zyprexa 20mg PS ORAL 20MG DAILY Fall ORAL Haemorrhage Celebrex 200mg SS ORAL 200MG DAILY Head Injury ORAL Laceration Depakote C Loss Of Consciousness Benztropine C Pulmonary Embolism Trazodone C Pulse Abnormal Respiratory Rate Increased 24-Jun-2005 12:19 PM Page: 2313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4119730-4Report Type:Expedited (15-DaCompany Report #GBS030513089 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Other Date:05/29/03ISR Number: 4119732-8Report Type:Expedited (15-DaCompany Report #JP_030500914 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Acute Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) Other Diabetes Mellitus Professional (Olanzapine) PS 10 MG/DAY Company Tegretol Representative (Carbamazepine) C Other Artane (Trihexyphenidyl Hydrochloride) C Risperdal (Risperidone) C Cercine (Diazepam) C Rohypnol (Flunitrazepam) C Hyserenin (Valproate Sodium) C Myslee (Zolpidem Tartrate) C Benzalin (Nitrazepam) C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Date:05/29/03ISR Number: 4120181-7Report Type:Expedited (15-DaCompany Report #USA030536651 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Bupropion C Chlorpromazine C Date:05/29/03ISR Number: 4120183-0Report Type:Expedited (15-DaCompany Report #USA030536660 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Zyprexa-Oral Suicide Attempt (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120186-6Report Type:Expedited (15-DaCompany Report #USA030537151 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 260 MG Representative Xanax (Alprazolam) C Oxycontin (Oxycodone Hydrochloride) C Date:05/29/03ISR Number: 4120188-XReport Type:Expedited (15-DaCompany Report #USA030536959 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Necrotising Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 1 MON Zyprexa Zydis-Oral (Olanzapine) (Olanzapine) SS 3 WK Haldol (Haloperidol) C Ativan (Lorazepam) C Date:05/29/03ISR Number: 4120189-1Report Type:Expedited (15-DaCompany Report #USA030536969 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/29/03ISR Number: 4120192-1Report Type:Expedited (15-DaCompany Report #EWC030534852 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa-Oral Initial or Prolonged Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS 35 MG Myoglobinuria Company Overdose Representative Suicide Attempt Other Thinking Abnormal Date:05/29/03ISR Number: 4120198-2Report Type:Expedited (15-DaCompany Report #FR_030502417 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Foreign Zyprexa-Oral Initial or Prolonged Thrombosis Health (Olanzapine) Myocardial Infarction Professional (Olanzapine) PS 5 MG/DAY Other Tanganil (Ethanolamine Acetylleucinate) C Sermion (Nicergoline) C Tanakan (Ginkgo 24-Jun-2005 12:19 PM Page: 2315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biloba Extract) C Trimetazidine C Aspirin C Date:05/29/03ISR Number: 4120225-2Report Type:Expedited (15-DaCompany Report #JP_030500898 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Olanzapine-Oral Initial or Prolonged Dysuria Study (Olanzapine) PS 2.5 MG DAY Renal Failure Health Impromen Urinary Retention Professional (Bromperidol) C Other Akineton (Biperiden Hydrochloride) C Date:05/29/03ISR Number: 4120226-4Report Type:Expedited (15-DaCompany Report #JP_030500928 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Foreign Zyprexa-Oral Dizziness Study (Olanzapine) Gait Disturbance Health (Olanzapine) PS 5 MG/DAY Professional Emilace Other (Nemonapride) C Artane (Trihexyphenidyl Hydrochloride) C Tegretol (Carbamazepine) C Gascon (Dimeticone) C Politose C Benzalin (Nitrazepam) C Alosenn C Date:05/29/03ISR Number: 4120227-6Report Type:Expedited (15-DaCompany Report #DE_030511235 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bilirubin Conjugated Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Complication Of Pregnancy Professional (Olanzapine) PS 9 MON Complications Of Maternal Other Exposure To Therapeutic Drugs Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Maternal Drugs Affecting Foetus Pregnancy Date:05/29/03ISR Number: 4120232-XReport Type:Expedited (15-DaCompany Report #EWC030534861 Age:77 YR Gender:Female I/FU:I Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 2316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Pneumonia Viral Foreign Zyprexa-Oral Shock Health (Olanzapine) Professional (Olanzapine) PS 5 MG Company Representative Other Date:05/29/03ISR Number: 4120567-0Report Type:Expedited (15-DaCompany Report #EWC030434661 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Foreign Zyprexa-Oral Initial or Prolonged Decreased Appetite Health (Olanzapine) Feeding Problem In Professional (Olanzapine) PS Newborn Other Fontex-Oral Maternal Drugs Affecting (Fluoxetine) Foetus (Fluoxetine Neonatal Disorder Hydrochloride) SS Pregnancy Somnolence Neonatal Date:05/29/03ISR Number: 4120568-2Report Type:Expedited (15-DaCompany Report #CA_030505920 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Self-Injury Foreign Zyprexa-Dispersible Overdose Health (Olanzapine) PS Professional Zyprexa-Oral Company (Olanzapine) SS Representative Lithium C Other Alprazolam C Zopiclone C Lorazepam C Date:05/29/03ISR Number: 4120570-0Report Type:Expedited (15-DaCompany Report #JP_030400730 Age:42 YR Gender:Male I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Anuria Aspartate Aminotransferase Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Pressure Systolic Decreased Blood Urea Increased C-Reactive Protein Increased Depressed Level Of Consciousness Flatulence Haemodialysis 24-Jun-2005 12:19 PM Page: 2317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Hypoxia Liver Disorder Report Source Product Role Manufacturer Route Dose Duration Multi-Organ Failure Foreign Zyprexa-Oral Myoglobinuria Health (Olanzapine) PS 10 MG/DAY Neuroleptic Malignant Professional Vegetamin A C Syndrome Company Depas (Etizolam) C Pancytopenia Representative Wintermin Pneumonia Other (Chlorpromazine Pyrexia Hydrochloride) C Renal Disorder Thyradin S Sepsis (Levothyroxine Staphylococcal Infection Sodium) C Tachycardia Alinamin F Urinary Retention (Fursultiamine) C White Blood Cell Count Magnesium Oxide C Yodel (Senna) C Date:05/29/03ISR Number: 4120574-8Report Type:Expedited (15-DaCompany Report #JP_030300513 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Foreign Zyprexa-Oral Initial or Prolonged Blood Glucose Health (Olanzapine) PS 10 MG/DAY Other Blood Sodium Professional Valerin (Valproate Grand Mal Convulsion Company Sodium) C Hyperammonaemia Representative Pursennid (Senna Irritability Other Leaf) C Social Avoidant Behaviour Magnesium Oxide C Risperidone C Date:05/29/03ISR Number: 4120576-1Report Type:Expedited (15-DaCompany Report #JP_030300503 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Hyperammonaemia Health (Olanzapine) Mood Altered Professional (Olanzapine) PS 20 MG/DAY Company Levotomin Representative (Levomepromazine Other Maleate) C Valerin (Valproate Sodium) C Thyradin S (Levothyroxine Sodium) C Pursennid (Senna Leaf) C Bromperidol C Date:05/29/03ISR Number: 4120806-6Report Type:Expedited (15-DaCompany Report #EWC030534744 Age:58 YR Gender:Male I/FU:F Outcome PT Other Agitation Akathisia Drug Ineffective Fall 24-Jun-2005 12:19 PM Page: 2318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Logorrhoea Mania Rotator Cuff Syndrome Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Foreign Olanzapine-Oral Weight Increased Health (Olanzapine) PS ORAL 20 MG/DAY Professional Seropram C Other Temesta C Quilonorm Retard C Efexor C Campral C Date:05/29/03ISR Number: 4120828-5Report Type:Expedited (15-DaCompany Report #JP_030500916 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Foreign Zyprexa-Oral Hepatic Cancer Metastatic Health (Olanzapine) Hepatomegaly Professional (Olanzapine) PS 15 MG/DAY Respiratory Failure Company Tegretol Representative (Carbamazepine) C Other Date:05/29/03ISR Number: 4120880-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143434 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify Tabs 15 Mg PS Otsuka Pruritus Pharmaceutical Company, Ltd. ORAL Interrupted on 23-Dec-2003. Restarted at reduced dose Zyprexa SS Lithium C Inderal C Zantac C Date:05/30/03ISR Number: 4120102-7Report Type:Expedited (15-DaCompany Report #B0299984A Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lithium Salt Intentional Misuse Health (Formulation Professional Unknown) (Lithium Salt) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Date:05/30/03ISR Number: 4120115-5Report Type:Expedited (15-DaCompany Report #B0299982A Age:33 YR Gender: I/FU:I Outcome PT Report Source Death Completed Suicide Literature Overdose Health 24-Jun-2005 12:19 PM Page: 2319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Lithium Salt (Formulation Unknown) (Lithium Salt) PS ORAL ORAL Hydrocodone + Paracetamol (Formulation Unknown) (Hydrocodone + SS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Date:05/30/03ISR Number: 4121196-5Report Type:Expedited (15-DaCompany Report #JP_030500887 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Delusion Study (Olanzapine) Hallucination Health (Olanzapine) PS 5 MG/DAY Professional Serenace(Haloperidol Other ) C Contomin(Chlorpromaz ine Hydrochloride) C Depas(Etizolam) C Wypax(Lorazepam) C Rohypnol(Flunitrazep am) C Date:06/02/03ISR Number: 4121727-5Report Type:Expedited (15-DaCompany Report #PHBS2003JP05265 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Foreign Melleril(Thioridazin Hospitalization - Prolonged Health e Hydrochloride) Initial or Prolonged Intentional Misuse Professional Tablet PS ORAL 200 MG/DAY, Suicide Attempt Other ORAL; ORAL Ventricular Fibrillation Zyprexa(Olanzapine) SS ORAL 80 MG/D, Ventricular Tachycardia ORAL; ORAL Date:06/02/03ISR Number: 4121816-5Report Type:Direct Company Report #CTU 194511 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Olanzapine 7.5mg Qhs PS 7.5MG QHS Hospitalization - Blood Creatine Quetiapine 25mg One SS Initial or Prolonged Phosphokinase Increased Synthroid C Catatonia Neuroleptic Malignant Syndrome Pyrexia Tachycardia 24-Jun-2005 12:19 PM Page: 2320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4122109-2Report Type:Direct Company Report #CTU 194569 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinson'S Disease Olanzapine 10mg PS 1 TAB HS Initial or Prolonged Pulmonary Embolism Date:06/02/03ISR Number: 4122147-XReport Type:Direct Company Report #USP 55874 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec 10mg PS Pfizer Uspg Somnolence Zyprexa 10mg SS Lilly Date:06/03/03ISR Number: 4122322-4Report Type:Direct Company Report #CTU 194621 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa PS Eli Lilly ORAL 30 MG QHS PO Hospitalization - Blood Ph Decreased Strattera (Eli Initial or Prolonged Confusional State Lilly) SS Eli Lilly 18 MG QAM X 8 Required Dry Mouth DOSES, 40 X Intervention to 14D THEN 60 Prevent Permanent MG Impairment/Damage Date:06/04/03ISR Number: 4123100-2Report Type:Direct Company Report #CTU 194947 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Effexor Xr PS ORAL ORAL Initial or Prolonged Depressed Level Of Zyprexa SS ORAL ORAL Consciousness Celebrex C Electromyogram Abnormal Flexeril C Haemodialysis Depakote C Myopathy Neurontin C Pain Synthroid C Pain In Extremity Ultram C Date:06/04/03ISR Number: 4123656-XReport Type:Direct Company Report #CTU 195028 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Olanzapine PS 15MG HS BY Initial or Prolonged Neutropenia MOUTH Aspirin C Rabeprazole Na C Simvastatin C Buspirone Hcl C Date:06/04/03ISR Number: 4123847-8Report Type:Expedited (15-DaCompany Report #EWC030434446 Age:32 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aspartate Initial or Prolonged Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 2321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased Pyrexia Report Source Product Role Manufacturer Route Dose Duration Rhabdomyolysis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Haldol Decanoate (Haloperidol Decanoate) C Date:06/04/03ISR Number: 4124167-8Report Type:Expedited (15-DaCompany Report #GBS030413039 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprex-Oral Drowning Consumer (Olanzapine) Health (Olanzapine) PS 12.5 MG/DAY Professional Risperidone C Other Date:06/04/03ISR Number: 4124168-XReport Type:Expedited (15-DaCompany Report #EWC030534852 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa-Oral Initial or Prolonged Overdose Health (Olanzapine) Rhabdomyolysis Professional (Olanzapine) PS 35 MG Suicide Attempt Company Thinking Abnormal Representative Other Date:06/04/03ISR Number: 4124169-1Report Type:Expedited (15-DaCompany Report #CA_030505920 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Attention-Seeking Foreign Zyprexa-Dispersible Behaviour Health (Olanzapine) Completed Suicide Professional (Olanzapine) PS Overdose Company Zyprexa-Oral Representative (Olanzapine) Other (Olanzapine) SS Lithium C Alprazolam C Zopiclone C Lorazepam C Date:06/04/03ISR Number: 4124170-8Report Type:Expedited (15-DaCompany Report #JP_030500880 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Intentional Misuse Company (Olanzapine) Representative (Olanzapine) PS Other Lexotan (Bromazepam) C Tofranil (Imipramine Hydrochloride) C Tryptanol 24-Jun-2005 12:19 PM Page: 2322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amitriptyline Hydrochloride) C Mucosta (Rebamipide) C Paxil (Paroxetine Hydrochloride) C Date:06/04/03ISR Number: 4124183-6Report Type:Expedited (15-DaCompany Report #GBS030513089 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Psychotic Disorder Health (Olanzapine) PS Professional Other Date:06/04/03ISR Number: 4124214-3Report Type:Expedited (15-DaCompany Report #GBS030513112 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Foreign Olanzapine-Oral Initial or Prolonged Blood Bicarbonate Literature (Olanzapine) PS 10 MG/DAY 4 WK Blood Creatine Health Phosphokinase Professional Blood Insulin Other Blood Ph Decreased Circulatory Collapse Depressed Level Of Consciousness Diabetic Ketoacidosis Insulin C-Peptide Somnolence Date:06/04/03ISR Number: 4124216-7Report Type:Expedited (15-DaCompany Report #GBS030513113 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Olanzapine-Oral Initial or Prolonged Increased Literature (Olanzapine) PS Blood Triglycerides Health Aspirin C Increased Professional Statin C Condition Aggravated Other Diabetes Mellitus Hyperosmolar State Date:06/04/03ISR Number: 4124231-3Report Type:Expedited (15-DaCompany Report #GBS030513124 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Olanzapine-Oral Therapeutic Agent Health (Olanzapine) PS Toxicity Professional Depixol (Flupentixol Other Decanoate) C Zopiclone C 24-Jun-2005 12:19 PM Page: 2323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/03ISR Number: 4124235-0Report Type:Expedited (15-DaCompany Report #EWC030534907 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:06/04/03ISR Number: 4124237-4Report Type:Expedited (15-DaCompany Report #EWC030534902 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:06/04/03ISR Number: 4124241-6Report Type:Expedited (15-DaCompany Report #DE_030511317 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:06/04/03ISR Number: 4124244-1Report Type:Expedited (15-DaCompany Report #GBS030513142 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/2 DAY Other Montelukast C Salbutamol C Atrovent (Ipratropium Bromide) C Lorazepam C Date:06/04/03ISR Number: 4124285-4Report Type:Expedited (15-DaCompany Report #B0300503A Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Overdose Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS Fluoxetine (Formulation Unknonw) (Fluoxetine) SS 24-Jun-2005 12:19 PM Page: 2324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/03ISR Number: 4124288-XReport Type:Expedited (15-DaCompany Report #B0300502A Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS Gabapentin (Formulation Unknown) (Gabapentin) SS Date:06/04/03ISR Number: 4124290-8Report Type:Expedited (15-DaCompany Report #B0300506A Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Health (Formulation Professional Unknown) (Bupropion Hydrochloride) PS ORAL ORAL Fluvoxamine (Formulation Unknown) (Fluvoxamine) SS Olanzapine (Formulation Unknown) (Olanzapine) SS Date:06/04/03ISR Number: 4124297-0Report Type:Expedited (15-DaCompany Report #B0300504A Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS Date:06/04/03ISR Number: 4124425-7Report Type:Expedited (15-DaCompany Report #USA030537656 Age:79 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Dysphagia (Olanzapine)(Olanzap Swelling ine) PS 24-Jun-2005 12:19 PM Page: 2325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/03ISR Number: 4124426-9Report Type:Expedited (15-DaCompany Report #USA030537180 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa - Oral Initial or Prolonged Mania (Olanzapine) Psychotic Disorder (Olanzapine) PS 2.5 MG/DAY 3 YR Lexapro (Escitalopram) C Date:06/04/03ISR Number: 4124428-2Report Type:Expedited (15-DaCompany Report #USA030537226 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa-Oral Drug Toxicity Company (Olanazapine) Overdose Representative (Olanazapine) PS 10 MG Toxicologic Test Abnormal Risperdal (Risperidone) C Date:06/04/03ISR Number: 4124430-0Report Type:Expedited (15-DaCompany Report #USA030537629 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Zyprexa-Oral Aphonia (Olanazapine) Hallucination, Visual (Olanazapine) PS 2.5 MG/DAY 2 DAY Restlessness Remeron (Mirtrazapine) C Haldol (Haloperidol) C Date:06/04/03ISR Number: 4124529-9Report Type:Expedited (15-DaCompany Report #USA030537107 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Strattera Initial or Prolonged Dyskinesia (Atomoxetine Hallucination, Auditory Hydrochloride) PS 25 MG/DAY Tremor Zyprexa-Oral (Olanzapine) (Olanzapine) SS Allegra (Fexofenadine Hydrochloride) C Eskalith (Lithium Carbonate) C Insulin C Microgestin Fe C Pancrease Microtabs C Paxil (Paroxetine Hydrochloride) C Date:06/04/03ISR Number: 4124532-9Report Type:Expedited (15-DaCompany Report #USA030537782 Age:2 YR Gender:Female I/FU:I Outcome PT Death Cardio-Respiratory Arrest Convulsion 24-Jun-2005 12:19 PM Page: 2326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Somnolence Staring Report Source Product Role Manufacturer Route Dose Duration Consumer Strattera Health (Atomoxetine Professional Hydrochloride) PS 30 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/2 DAY Date:06/04/03ISR Number: 4124536-6Report Type:Expedited (15-DaCompany Report #US_030594696 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Literature Olanzapine-Oral Initial or Prolonged Increased Health (Olanzapine) PS 10 MG/DAY Other Aspartate Professional Aminotransferase Increased Brief Psychotic Disorder, With Postpartum Onset Complications Of Maternal Exposure To Therapeutic Drugs Delusion Hallucination, Auditory Pregnancy Date:06/04/03ISR Number: 4124539-1Report Type:Expedited (15-DaCompany Report #USA030537504 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Health Zyprexa-Oral Sedation Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Benzodiazepine C Date:06/06/03ISR Number: 4126045-7Report Type:Expedited (15-DaCompany Report #2003103156 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Benadryl Initial or Prolonged Condition Aggravated Professional (Diphenhydramine) PS ORAL ORAL Depression Olanzapine Dyspnoea (Olanzapine) SS ORAL 30 TABS OF 15 Mental Status Changes MG EACH ONCE, Productive Cough ORAL Psychotic Disorder Ethanol (Ethanol) SS ORAL SEVERAL Suicide Attempt SHOTS, ORAL Wheezing Quetiapine Fumarate (Quetiapine Fumarate) C Alprazolam (Alprazolam) C Enalapril (Enalapril) C Calcium Carbonate (Calcium Carbonate) C 24-Jun-2005 12:19 PM Page: 2327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paracetamol (Paracetamol) C Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C Valproate Semisodium (Valproate Semisodium) C Date:06/09/03ISR Number: 4126152-9Report Type:Expedited (15-DaCompany Report #USA030332048 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Zyprexa-Oral Initial or Prolonged Anger (Olanzapine) PS 20 MG/DAY Drug Effect Decreased Seroquel (Quetiapine Flatulence Fumarate0 C Psychotic Disorder Clonazepam C Weight Increased Date:06/09/03ISR Number: 4126369-3Report Type:Expedited (15-DaCompany Report #2003GB01364 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Foreign Quetiapine PS 25 MG BID PO Intervention to Circulatory Collapse Health Olanzapine SS 20 MG QD PO Prevent Permanent Hypotonia Professional Lansoprazole C Impairment/Damage Other Lorazepam C Finasteride C Date:06/09/03ISR Number: 4126515-1Report Type:Expedited (15-DaCompany Report #2003GB01364 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Foreign Quetiapine PS ORAL 25 MG BID PO Intervention to Circulatory Collapse Health Olanzapine SS ORAL 20 MG QD PO Prevent Permanent Hypotonia Professional Lansoprazole C Impairment/Damage Other Lorazepam C Finasteride C Date:06/11/03ISR Number: 4127883-7Report Type:Expedited (15-DaCompany Report #JP_030400701 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Below Foreign Zyprexa-Oral Therapeutic Health (Olanzapine) Epistaxis Professional (Olanzapine) PS 10 MG/DAY Granulocyte Count Company Levotomin C Decreased Representative Pallor 24-Jun-2005 12:19 PM Page: 2328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/03ISR Number: 4127999-5Report Type:Expedited (15-DaCompany Report #EWC030534936 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Olanzapine-Oral Ulcer Health (Olanzapine) PS 10 MG/DAY Professional Other Date:06/11/03ISR Number: 4128002-3Report Type:Expedited (15-DaCompany Report #DE_030511395 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Hospitalization - Alanine Aminotransferase Health (Olanzapine) Initial or Prolonged Increased Professional (Olanzapine) PS 20 MG/DAY Aspartate Company Euthyrox Aminotransferase Representative (Levothyroxine Increased Other Sodium) C Blood Creatine Truxal Phosphokinase Increased (Chlorprothixene Blood Creatinine Hydrochloride) C Increased Adalat (Nifedipine) C Blood Lactate Euglucon Dehydrogenase Increased (Glibenclamide) C Blood Urea Increased Neuroleptic Malignant Syndrome Pulmonary Embolism Pyrexia Date:06/11/03ISR Number: 4128004-7Report Type:Expedited (15-DaCompany Report #CA_030505972 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Zyprexa-Oral Other Congestive Health (Olanzapine) Myocarditis Professional (Olanzapine) PS 40 MG Company Loxapine C Representative Activan (Lorazepam) C Other Date:06/11/03ISR Number: 4128009-6Report Type:Expedited (15-DaCompany Report #JP_030501007 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Infarction Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 10 MG/DAY Professional Tolopelon Other (Timiperone) C Biofermin C Trihexyphenidyl Hydrochloride C Towarat (Nifedipine) C Renivace (Enalapril Maleate) C Alfacalcidol C Vegetamin A C 24-Jun-2005 12:19 PM Page: 2329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Silece (Flunitrazepam) C Contomin (Chlorpromazine Hydrochloride) C Date:06/11/03ISR Number: 4128021-7Report Type:Expedited (15-DaCompany Report #GBS030513169 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Zyprexa-Oral Hospitalization - Phosphokinase Increased Health (Olanzapine) Initial or Prolonged Hyperpyrexia Professional (Olanzapine) PS 12.5 MG/DAY Hypertension Other Zimovane (Zopiclone) C Incontinence Edronax (Reboxetine) C Joint Dislocation Lactulose C Leukocytosis Procyclidine C Muscle Rigidity Neuroleptic Malignant Syndrome Tachycardia Date:06/11/03ISR Number: 4128023-0Report Type:Expedited (15-DaCompany Report #US_030594835 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperpyrexia Literature Olanzapine-Oral Hospitalization - Hypotension Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Injection Site Professional Paroxetine C Other Haemorrhage Mental Status Changes Muscle Rigidity Prothrombin Time Prolonged Tachycardia Tremor Date:06/11/03ISR Number: 4128047-3Report Type:Expedited (15-DaCompany Report #JP_030500944 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Zyprexa-Oral Initial or Prolonged Chest X-Ray Abnormal Health (Olanzapine) Eosinophil Count Professional (Olanzapine) PS 10 MG/DAY Increased Company Risperdal Fall Representative (Risperidone) C Femoral Neck Fracture Other Flunitrazepam C Pleural Effusion Chinese Medicine C Pyrexia White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/03ISR Number: 4128049-7Report Type:Expedited (15-DaCompany Report #GBS030513161 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Olanzapine-Oral Bradycardia Health (Olanzapine) PS 20 MG/1 DAY Circulatory Collapse Professional Quetiapine C Hypotonia Other Lansoprazole C Lorazepam C Finasteride C Date:06/11/03ISR Number: 4128052-7Report Type:Expedited (15-DaCompany Report #GBS030513158 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Olanzapine-Oral Phosphokinase Increased Health (Olanzapine) PS 20 MG Electrocardiogram Qt Professional Zuclopenthixol Prolonged Other Acetate C Supraventricular Methadone C Extrasystoles Diazepam C Valproate Sodium C Date:06/11/03ISR Number: 4128053-9Report Type:Expedited (15-DaCompany Report #EWC030534953 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Depression Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Temesta (Lorazepam) C Date:06/11/03ISR Number: 4128054-0Report Type:Expedited (15-DaCompany Report #FR_030502465 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa-Oral Initial or Prolonged Femoral Neck Fracture Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Representative Other Date:06/11/03ISR Number: 4128810-9Report Type:Expedited (15-DaCompany Report #USA030433494 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Health Zyprexa Atherosclerosis Professional Drug Screen Positive Company (Olanzapine) PS ORAL 500 MG Drug Toxicity Representative Paxil Hepatic Steatosis (Paroxetine Hydrochloride) C Bupropion C Pritor (Telmisartan) C Neurontin (Gabapentin) C 24-Jun-2005 12:19 PM Page: 2331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Lactulose C Date:06/11/03ISR Number: 4128813-4Report Type:Expedited (15-DaCompany Report #USA030330980 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Increased Health Zyprexa PS ORAL 5 MG/DAY Hospitalization - Blood Urea Increased Professional Lexapro Initial or Prolonged Coma Company (Escitalopram) C Other Convulsion Representative Neuroleptic Malignant Syndrome Overdose Sinus Tachycardia Somnolence Ventricular Extrasystoles Date:06/11/03ISR Number: 4128877-8Report Type:Expedited (15-DaCompany Report #USA030537804 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Prozac Exposure To Therapeutic Professional (Fluoxetine Drugs Hydrochloride) PS TRANSPLACENTAL Feeling Jittery Zyprexa-Oral Hyperreflexia (Olanazapine) Maternal Drugs Affecting (Olanazapine) SS TRANSPLACENTAL Foetus Albuterol C Neonatal Hypotension Flovent (Fluticasone Serotonin Syndrome Propionate) C Tremor Date:06/11/03ISR Number: 4128880-8Report Type:Expedited (15-DaCompany Report #USA020819494 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Prozac Initial or Prolonged Anger Professional (Fluoxetine Complications Of Maternal Hydrochloride) PS ORAL Exposure To Therapeutic Zyprexa-Oral Drugs (Olanazapine) SS ORAL 10 MG/DAY Depression Homicidal Ideation Maternal Drugs Affecting Foetus Postpartum Depression Premature Baby Premature Labour Suicidal Ideation Treatment Noncompliance 24-Jun-2005 12:19 PM Page: 2332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/03ISR Number: 4129127-9Report Type:Expedited (15-DaCompany Report #USA030538190 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Disorder Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine) Gastric Ulcer Haemorrhage (Olanzapine) PS 15 MG Haemoglobin Avapro (Irbesartan) C Hyperventilation Demadex (Torasemide) C Paraesthesia Depakote (Valproate Weight Increased Semidosium) C Wheezing Iron C Paxil (Paroxetine Hydrochloride) C Zonegran (Zonisamide) C Date:06/12/03ISR Number: 4127663-2Report Type:Direct Company Report #CTU 195640 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Olanzapine Lilly PS Lilly ORAL 5 MG QHS ORAL Fall Valproate C Lithium C Date:06/12/03ISR Number: 4128874-2Report Type:Expedited (15-DaCompany Report #DE_980500017 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa(Olanzapine) PS 5 MG/DAY Breast Discomfort Literature Saroten(Amitriptylin Depression Health e Hydrochloride) C Lactation Disorder Professional Neutropenia Other Palpitations Date:06/12/03ISR Number: 4128876-6Report Type:Expedited (15-DaCompany Report #DE_990200877 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa(Olanzapine) PS 40 MG/DAY Initial or Prolonged Febrile Neutropenia Literature Lorazepam C General Physical Health Health Risperidone C Deterioration Professional Benperidol C Hypersensitivity Other Leukopenia Overdose Date:06/12/03ISR Number: 4128879-1Report Type:Expedited (15-DaCompany Report #EWC020430632 Age:66 YR Gender:Male I/FU:F Outcome PT Life-Threatening Blood Albumin Decreased Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Mb Increased Drug Level Above Therapeutic 24-Jun-2005 12:19 PM Page: 2333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gingival Bleeding Neutrophil Percentage Increased Report Source Product Role Manufacturer Route Dose Duration Parotitis Foreign Olanzapine-Oral Petechiae Health (Olanzapine) PS 30 MG/DAY Staphylococcal Professional Augmentin C Bacteraemia Company Fraxiparine(Heparin- Thrombocytopenic Purpura Representative Fraction, Calcium Other Salt) C Orfiril(Valproate Sodium) C Date:06/12/03ISR Number: 4128896-1Report Type:Expedited (15-DaCompany Report #DE_001203797 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Foreign Zyprexa (Olanzapine) PS 5 MG/DAY Initial or Prolonged Anaemia Megaloblastic Health Asthenia Professional Bone Marrow Depression Other Bone Marrow Toxicity Drug Toxicity Dyspnoea Folate Deficiency Pancytopenia Pernicious Anaemia Pyrexia Weight Decreased Date:06/12/03ISR Number: 4128897-3Report Type:Expedited (15-DaCompany Report #DE_010505759 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa (Olanzapine) PS 15 MG/DAY Initial or Prolonged Leukopenia Health Professional Other Date:06/12/03ISR Number: 4128899-7Report Type:Expedited (15-DaCompany Report #CA_020204815 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Foreign Olanzapine-Oral Life-Threatening Neutropenia Study (Olanzapine) PS 20 MG Hospitalization - Pancytopenia Health Hydrochlorothiazide C Initial or Prolonged Pneumonia Professional Coversyl Other Streptococcal Sepsis Other (Perindopril) C Salbutamol C Date:06/12/03ISR Number: 4128901-2Report Type:Expedited (15-DaCompany Report #DE_0001011899 Age:73 YR Gender:Female I/FU:F Outcome PT Hospitalization - Breast Cancer Metastatic Initial or Prolonged Haemolytic Anaemia Neoplasm Recurrence Thrombocytopenia 24-Jun-2005 12:19 PM Page: 2334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa (Olanzapine) PS 10 MG /DAY 2 MON Health Acerbon (Lisinopril) C Professional Other Date:06/12/03ISR Number: 4128904-8Report Type:Expedited (15-DaCompany Report #DE_010806485 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Zyprexa (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Health Sifrol (Pramipexole Other Professional Dihydrochloride) C Other Madopar Depot C Potassium C Dopergin (Lisuride Maleate) C Zyloric (Allopurinol) C Bazoton (Urtica Extract) C Arelix (Piretanide) C Sandocal (Calcium Glubionate) C Norvasc (Amlodipine Besilate0 C Eunerpan (Melperone Hydrochloride) C Date:06/12/03ISR Number: 4128908-5Report Type:Expedited (15-DaCompany Report #EWC990202778 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Normochromic Normocytic Literature Flurazepam C Anaemia Health White Blood Cell Count Professional Decreased Other Date:06/12/03ISR Number: 4128999-1Report Type:Expedited (15-DaCompany Report #US97050274A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Zyprexa (Olanzapine) PS 50 MG DAY 3 MON Neutropenia Professional Ativan Thrombocytopenia Company (Lorazepam) C White Blood Cell Count Representative Ambien (Zolpidem Tartrate) C Date:06/12/03ISR Number: 4129136-XReport Type:Expedited (15-DaCompany Report #US97023259A Age:66 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Zyprexa (Olanzapine) PS 10 MG/ 1 DAY Aspiration Professional Propylthiouracil C Blood Bilirubin Cogentin Blood Thyroid Stimulating (Benzatropine Hormone Mesilate) C Candiduria Vitamin C Eosinophil Percentage Paxil (Paroxetine Increased Hydrochloride) C Haematocrit Depakote (Valproate Haemoglobin Semisodium) C Haptoglobin Multivitamin Lymphocyte Percentage (Multivitamins) C Increased Mean Cell Volume Microcytosis Monocyte Percentage Increased Platelet Count Polychromasia Pyrexia Red Blood Cell Count Tachycardia Thyroxine Free White Blood Cell Count Date:06/12/03ISR Number: 4129137-1Report Type:Expedited (15-DaCompany Report #US_010770342 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa Lymphocyte Percentage Professional Zydis(Olanzapine) PS 20 MG/DAY Increased Company Depakote(Valproate Monocyte Percentage Representative Semisodium) C Increased Haldol(Haloperidol) C Reticulocyte Percentage Increased White Blood Cell Count Decreased Date:06/12/03ISR Number: 4129146-2Report Type:Expedited (15-DaCompany Report #2003AP02157 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Lisinopril PS Health Olanzapine SS Professional Mirtazapine SS Date:06/12/03ISR Number: 4129261-3Report Type:Expedited (15-DaCompany Report #DE_030511354 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 2336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/03ISR Number: 4129291-1Report Type:Expedited (15-DaCompany Report #US_010770346 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa (Olanzapine) PS 40 MG/DAY Alanine Aminotransferase Professional Depakote(Valproate Reticulocyte Count Company Semisodium) C Representative Haldol(Haloperidol) C Cogentin (Benzatropine Mesilate) C Klonopin(Clonazepam) C Date:06/16/03ISR Number: 4130332-6Report Type:Expedited (15-DaCompany Report #002#2#2002-00109 (0) Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Reglan-10mg-Tablet Initial or Prolonged Arthropathy (Metoclopramide Hcl) PS ORAL 10MG, 4 IN 1 Disability Blepharospasm D, ORAL Blood Pressure Increased Prochlorperazine-Edi Chest Discomfort sylate SS Condition Aggravated Haloperidol SS Conversion Disorder Gabapentin SS Depression Olanzapine SS Diarrhoea Lisinopril C Disturbance In Attention Diazepam C Drug Withdrawal Syndrome Mylanta C Dry Mouth Metoprolol C Dysphagia Heparin C Dysphemia Clopidogrel C Dyspnoea Dystonia Eye Pain Feeling Abnormal Halo Vision Headache Hyperhidrosis Impaired Driving Ability Malaise Migraine Muscle Spasms Nausea Nervousness Nightmare Obsessive-Compulsive Disorder Palpitations Paraesthesia Photosensitivity Reaction Posture Abnormal Restlessness Sleep Apnoea Syndrome Speech Disorder Strabismus Syncope Tardive Dyskinesia Tic Tremor Visual Acuity Reduced 24-Jun-2005 12:19 PM Page: 2337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/03ISR Number: 4130480-0Report Type:Expedited (15-DaCompany Report #03P-163-0221101-00 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS Olanzapine SS Date:06/16/03ISR Number: 4130481-2Report Type:Expedited (15-DaCompany Report #03P-163-0221095-00 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS Olanzapine SS Date:06/17/03ISR Number: 4130804-4Report Type:Direct Company Report #CTU 195950 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Olanzapine 5 Mg PS ORAL 5 MG QHS ORAL Hospitalization - Fall Ultracet 37.5/325 Mg SS ORAL 37.5/325 Q8H Initial or Prolonged ORAL Trazodone C Mirtazapine C Date:06/17/03ISR Number: 4131236-5Report Type:Expedited (15-DaCompany Report #USA030537226 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa-Oral Drug Toxicity Health (Olanzapine) Overdose Professional (Olanzapine) PS 10 MG Toxicologic Test Abnormal Company Risperdal Representative (Risperidone) C Prolixin Decanoate (Fluphenazine Decanoate) C Date:06/17/03ISR Number: 4131345-0Report Type:Expedited (15-DaCompany Report #03P-163-0221135-00 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil Health (Isoptin) PS ORAL PER ORAL Professional Amitriptyline SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL 24-Jun-2005 12:19 PM Page: 2338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/03ISR Number: 4131475-3Report Type:Expedited (15-DaCompany Report #USA030538312 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Zyprexa-Oral Initial or Prolonged Confusional State Professional (Olanzapine) Other Haemorrhage (Olanzapine) PS 5 MG Hepatic Function Abnormal Antibiotic C Neuroleptic Malignant Vitamin B12 C Syndrome Date:06/17/03ISR Number: 4131482-0Report Type:Expedited (15-DaCompany Report #USA030638450 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zyprexa-Oral Initial or Prolonged Condition Aggravated Professional (Olanzapine) Insomnia Company (Olanzapine) PS Psychotic Disorder Representative Date:06/17/03ISR Number: 4131488-1Report Type:Expedited (15-DaCompany Report #USA030638425 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 20 MG Representative Date:06/17/03ISR Number: 4131490-XReport Type:Expedited (15-DaCompany Report #USA030638580 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Zyprexa-Oral Fatigue (Olanzapine) Medication Error (Olanzapine) PS 5 MG/DAY Myelitis Transverse Luvox (Fluvoxaine Obsessive-Compulsive Maleate) C Disorder Trileptal (Oxcarbazepine) C Premarin (Estrogens Conjugated) C Date:06/17/03ISR Number: 4131491-1Report Type:Expedited (15-DaCompany Report #USA030638582 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative 24-Jun-2005 12:19 PM Page: 2339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/03ISR Number: 4131506-0Report Type:Expedited (15-DaCompany Report #USA030638666 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 7.5 MG/DAY Representative Celexa (Citalopram Hydrobromide) C Date:06/17/03ISR Number: 4131589-8Report Type:Expedited (15-DaCompany Report #USA030638821 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Increased Appetite Professional (Olanzapine) Intentional Misuse Company (Olanzapine) PS Treatment Noncompliance Representative Weight Decreased Weight Increased Date:06/17/03ISR Number: 4131634-XReport Type:Expedited (15-DaCompany Report #EWC030534999 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Exanthem Foreign Zyprexa-Oral Pruritus Generalised Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Ritalin Representative (Methylphenidate Other Hydrochloride) C Nemexin (Naltrexone Hydrochloride) C Seropram (Citalopram Hydrobromide) C Date:06/17/03ISR Number: 4131636-3Report Type:Expedited (15-DaCompany Report #AU_030606335 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Avanza (Mirtazapine) C Date:06/17/03ISR Number: 4131638-7Report Type:Expedited (15-DaCompany Report #EWC030635030 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Olanzapine-Oral Initial or Prolonged Dependence Health (Olanzapine) PS 100 MG/DAY Drug Abuser Professional Dysarthria Company Muscle Rigidity Representative Neck Pain Other Overdose Somnolence Treatment Noncompliance 24-Jun-2005 12:19 PM Page: 2340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/03ISR Number: 4131639-9Report Type:Expedited (15-DaCompany Report #EWC030635038 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Lorazepam C Anafranil (Clomipramine Hydrochloride) C Date:06/17/03ISR Number: 4131641-7Report Type:Expedited (15-DaCompany Report #EWC030635059 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mouth Haemorrhage Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Date:06/17/03ISR Number: 4131721-6Report Type:Expedited (15-DaCompany Report #EWC030534810 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Foreign Olanzapine-Oral Malignant Health (Olanzapine) PS 20 MG/DAY Liver Function Test Professional Paroxetine C Abnormal Other Malaise Nausea Date:06/17/03ISR Number: 4131729-0Report Type:Expedited (15-DaCompany Report #GBS030513161 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Olanzapine-Oral Bradycardia Health (Olanzapine) PS 20 MG/1 DAY Circulatory Collapse Professional Quetiapine C Drug Interaction Other Lansoprazole C Potentiation Lorazepam C Hypotonia Finasteride C Date:06/17/03ISR Number: 4131734-4Report Type:Expedited (15-DaCompany Report #GBS030513124 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Olanzapine-Oral Other Brain Oedema Health (Olanzapine) PS 20 MG/DAY Cardiomegaly Professional Depixol(Flupentixol Choking Other Decanoate) C Drug Screen Positive Zopiclone C Hepatitis C Overdose Therapeutic Agent Toxicity Ventricular Hypertrophy Vomiting 24-Jun-2005 12:19 PM Page: 2341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/03ISR Number: 4131735-6Report Type:Expedited (15-DaCompany Report #JP_030400730 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa-Oral Hospitalization - Anuria Health (Olanzapine) Initial or Prolonged Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Company Vegetamin A C Blood Creatine Representative Depas (Etizolam) C Phosphokinase Increased Other Wintermin Blood Pressure Systolic (Chlorpromazine Decreased Hydrochloride) C C-Reactive Protein Thyradin S Flatulence (Levothyroxine Haemodialysis Sodium) C Infection Alinamin F Liver Disorder (Fursultiamine) C Myoglobinuria Magnesium Oxide C Neuroleptic Malignant Yodel (Senna) C Syndrome Pancytopenia Pneumonia Renal Impairment Tachycardia Urinary Retention Date:06/17/03ISR Number: 4131737-XReport Type:Expedited (15-DaCompany Report #JP_030500914 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Acute Foreign Zyprexa-Oral Initial or Prolonged Hyperglycaemia Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Tegretol Representative (Carbamazepine) C Other Artane (Trihexyphenidyl Hydrochloride) C Risperdal (Risperidone) C Cercine (Diazepam) C Rohypnol (Flunitrazepam) C Hyserenin (Valproate Sodium) C Myslee (Zolpidem Tartrate) C Benzalin (Nitrazepam) C Serenace (Haloperidol) C Akineton (Biperiden Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/03ISR Number: 4131784-8Report Type:Expedited (15-DaCompany Report #JP_030400701 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Epistaxis Foreign Zyprexa-Oral Granulocyte Count Health (Olanzapine) Decreased Professional (Olanzapine) PS 10 MG/DAY Pallor Company Levotomin Representative (Levomepromazine Other Maleate) C Date:06/17/03ISR Number: 4131787-3Report Type:Expedited (15-DaCompany Report #JP_030300564 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Olanzapine-Oral Infarction Study (Olanzapine) PS 10 MG DAY Asthenia Health Mercazole Blood Pressure Decreased Professional (Thiamazole) C Bradycardia Other Limas (Lithium Cardiac Failure Carbonate) C Depressed Level Of Akineton (Biperiden Consciousness Hydrochloride) C Gait Disturbance Barnetil (Sultopride) C Vegetamin B C Rhythmy (Rilmazafone) C Gatifloxacin C Date:06/18/03ISR Number: 4131207-9Report Type:Direct Company Report #CTU 196061 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Zyprexa PS ORAL 5 MG 1 X ORAL Dizziness Neurontin C Loss Of Consciousness Ovcon-35 C Palpitations Albuterol C Date:06/19/03ISR Number: 4132829-1Report Type:Expedited (15-DaCompany Report #DEWYE171512JUN03 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Foreign Tavor (Lorazepam) PS ORAL UNKNOWN Somnolence Health AMOUNT Professional (THERAPEUTICA Other L DOSIS) ORAL 1 DAY Hypnorex - Slow Release (Lithium Carbonate, 0) SS ORAL 1 TABLET (=400 MG) ORAL 1 DAY Trevilor (Venlafaxine Hydrochloride, Tablet, 0) SS ORAL 2 TABLETS (UNKNOWN STREGTH) ORAL 1 DAY Zopiclone 24-Jun-2005 12:19 PM Page: 2343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zopiclone, 0) SS ORAL 4 TABLETS (=30 MG) ORAL 1 DAY Zyprexa (Olanzapine. 0) SS ORAL 1 TABLET (=10 MG) ORAL 1 DAY Date:06/19/03ISR Number: 4133053-9Report Type:Expedited (15-DaCompany Report #EMADSS2003004249 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Risperdal Initial or Prolonged Positive Health (Risperidone) Rhabdomyolysis Professional Tablets PS ORAL 2 MG, ORAL : 4 MG , ORAL Zyprexa (Olanzapine) SS 15 MG L-Thyroxin (Unspecified) Levothyroxine Sodium C Date:06/19/03ISR Number: 4188559-3Report Type:Periodic Company Report #325133 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Literature Clonazepam Health (Clonazepam) PS ORAL ORAL Professional Amitriptyline (Amtriptyline Hydrochloride) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Date:06/20/03ISR Number: 4133829-8Report Type:Expedited (15-DaCompany Report #2002-10-2453 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Alcohol Interaction Disability Blood Caffeine Increased Other Bronchitis Chest Pain Conversion Disorder Convulsion Disturbance In Attention Drug Interaction Drug Withdrawal Syndrome Dysphagia Dysphonia Eye Movement Disorder Fatigue Head Discomfort Headache Mastitis Menopausal Symptoms Mental Disorder Muscle Spasms Musculoskeletal Discomfort Nausea Neck Pain 24-Jun-2005 12:19 PM Page: 2344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuralgia Reading Disorder Respiratory Disorder Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Other Trilafon Tardive Dyskinesia (Perphenazine) Throat Tightness Tablets PS ORAL 2-6 MG QD Vomiting ORAL Weight Decreased Zyprexa (Olanzapine) Tablets SS ORAL ORAL Trazodone SS 50 MG HS Prozac SS 30-10 MG QE Caffeine SS Lithium SS Vicodin C Flexeril C Indocin C Multivitamins C Ativan C Thyroid C Clonazepam C Beclomethasone Nasal Solution C Ibuprofen C Alaprazolam C Cephalexin C Septran Ds (Trimethoprim/Sulfam ethoxazole) C Date:06/24/03ISR Number: 4133949-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0302485A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Zyban PS Glaxosmithkline ORAL 12G Single Hospitalization - Coma Professional dose 1 DAY Initial or Prolonged Convulsion Zyprexa SS ORAL 80TAB Single Intentional Misuse dose Pyrexia Imovane SS ORAL Suicide Attempt Tachycardia Date:06/24/03ISR Number: 4134710-0Report Type:Direct Company Report #CTU 196528 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Parkinson'S Disease Zyprexa 2.5mg Then 5mg After 6th Day PS ORAL 1 DAILY ORAL 2.5 MG THEN 5MG AFTER 6TH DAY. Date:06/24/03ISR Number: 4135295-5Report Type:Expedited (15-DaCompany Report #DE_980700205 Age:50 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Cholesterol Initial or Prolonged Increased Blood Triglycerides 24-Jun-2005 12:19 PM Page: 2345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Dyskinesia Hepatitis Cholestatic Menorrhagia Report Source Product Role Manufacturer Route Dose Duration Uterine Leiomyoma Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Company Minisiston C Representative Tavor (Lorazepam) C Other Date:06/24/03ISR Number: 4135296-7Report Type:Expedited (15-DaCompany Report #CA_030505972 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa-Oral Initial or Prolonged Congestive Health (Olanzapine) Other Myocarditis Professional (Olanzapine) PS 40 MG Company Loxapine C Representative Ativan (Lorazepam) C Other Date:06/24/03ISR Number: 4135297-9Report Type:Expedited (15-DaCompany Report #EWC020230051 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Exertional Foreign Zyprexa-Oral Initial or Prolonged Gamma-Glutamyltransferase Health (Olanzapine) Increased Professional (Olanzapine) PS 20 MG/DAY Hypertension Other Haloperidol C Renal Failure Date:06/24/03ISR Number: 4135299-2Report Type:Expedited (15-DaCompany Report #EWC020129720 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epilepsy Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Other Fenobarbital C Date:06/24/03ISR Number: 4135300-6Report Type:Expedited (15-DaCompany Report #CA_030505920 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Attention-Seeking Foreign Zyprexa-Dispersible Behaviour Health (Olanzapine) PS 15 MG/DAY Overdose Professional Zyprexa-Oral Company (Olanzapine) SS 15 MG/DAY Representative Lithium C Other Alprazolam C Zopiclone C Lorazepam C 24-Jun-2005 12:19 PM Page: 2346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/03ISR Number: 4135301-8Report Type:Expedited (15-DaCompany Report #AU_030606335 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG/DAY Professional Avanza (Mirtazapine) C Other Date:06/24/03ISR Number: 4135304-3Report Type:Expedited (15-DaCompany Report #JP_030500887 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Zyprexa-Oral Initial or Prolonged Extrapyramidal Disorder Health (Olanzapine) Hallucination Professional (Olanzapine) PS 5 MG/DAY Insomnia Other Serenance Soliloquy (Haloperidol) C Contomin (Chlorpromazine Hydrochloride0 C Depas (Etizolam) C Wypax (Lorazepam) C Date:06/24/03ISR Number: 4135338-9Report Type:Expedited (15-DaCompany Report #GBS030613242 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Foreign Olanzapine-Oral Tongue Ulceration Health (Olanzapine) PS 2.5 MG Professional Mirtazapine C Other Date:06/24/03ISR Number: 4135339-0Report Type:Expedited (15-DaCompany Report #DE_030611463 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Zyprexa-Oral Leukopenia Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Date:06/24/03ISR Number: 4135340-7Report Type:Expedited (15-DaCompany Report #EWC020230052 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Zyprexa-Oral Life-Threatening Cardiac Arrest Health (Olanzapine) Other Leukopenia Professional (Olanzapine) PS ORAL 7.5 MG/DAY Shock Other Lasix (Furosemide) C Thrombocytopenia Madopar C Triatec (Ramipril) C Spectrum (Ceftazidime) C Calciparina Chay (Heparin Calcium) C 24-Jun-2005 12:19 PM Page: 2347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/03ISR Number: 4135341-9Report Type:Expedited (15-DaCompany Report #JP_030601117 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Study (Olanzapine) Constipation Health (Olanzapine) PS 10 MG/DAY Hyperglycaemia Professional Vegetamin A C Polydipsia Other Depakene (Valproate Polyuria Sodium) C Weight Increased Seroquel C White Blood Cell Count Limas (Lithium Increased Carbonate) C Risperdal (Risperidone) C Date:06/24/03ISR Number: 4135342-0Report Type:Expedited (15-DaCompany Report #JP_030601114 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Metrorrhagia Foreign Zyorexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY 1 YR Other Date:06/24/03ISR Number: 4135350-XReport Type:Expedited (15-DaCompany Report #GBS030613214 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Olanzapine-Oral(Olan Initial or Prolonged Renal Failure Health zapine) PS 20 MG/1 DAY Rhabdomyolysis Professional Zopiclone C Other Date:06/24/03ISR Number: 4135352-3Report Type:Expedited (15-DaCompany Report #EWC030635014 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral(Olanzap Initial or Prolonged Convulsion Health ine) PS 2.5 MG/DAY Loss Of Consciousness Professional Coraspin(Acetylsalic Other ylic Acid) C Trental (Pentoxifylline) C Cerebrovascular Illness C Novalgin (Metamizole Sodium) C Ulcuran (Ranitidine Hdyrochloride) C Metpamid (Metoclopramide) C 24-Jun-2005 12:19 PM Page: 2348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/03ISR Number: 4135353-5Report Type:Expedited (15-DaCompany Report #FR_030602509 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Hypothermia Health (Olanzapine) PS 15 MG/DAY Professional Company Representative Other Date:06/24/03ISR Number: 4135386-9Report Type:Expedited (15-DaCompany Report #US_030695368 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Olanzapine-Oral Initial or Prolonged Blood Cholesterol Literature (Olanzapine) PS 7 MON Increased Health Clozapine C Condition Aggravated Professional Lithium C Diabetes Mellitus Other Psychotic Disorder Date:06/24/03ISR Number: 4135469-3Report Type:Expedited (15-DaCompany Report #JP_030500898 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Olanzapine-Oral Initial or Prolonged Renal Failure Study (Olanzapine) PS 2.5 MG DAY Health Impromen(Bromperidol Professional ) C Other Akineton(Biperiden Hydrochloride) C Date:06/24/03ISR Number: 4135486-3Report Type:Expedited (15-DaCompany Report #EWC030635138 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-0ral Initial or Prolonged Dysarthria Health (Olanzapine) Encephalopathy Professional (Olanzapine) PS 15 MG/DAY Hyperpyrexia Other Carbolithium Hypothermia (Lithium Carbonate) C Sopor Clopixol (Zuclopenthixol Decanoate) C Novonorm (Repaglinide) C Rivotril (Clonazepam) C Bb-K8 (Amikacin Sulfate) C Trental (Pentoxifylline) C 24-Jun-2005 12:19 PM Page: 2349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/03ISR Number: 4135575-3Report Type:Expedited (15-DaCompany Report #US_030695244 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Literature Olanzapine-Oral Initial or Prolonged Neuroleptic Malignant Health (Olanzapine) PS 5 MG/DAY Other Syndrome Professional Parkinsonism Date:06/24/03ISR Number: 4135585-6Report Type:Expedited (15-DaCompany Report #USA030639163 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paralysis Health Zyprexa-Oral Initial or Prolonged Wheelchair User Professional (Olanzapine) PS 20 MG/DAY Other Company Seroquel (Quetiapine Representative Fumarate) C Date:06/24/03ISR Number: 4135586-8Report Type:Expedited (15-DaCompany Report #USA030638827 Age:2 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrooesophageal Reflux Health Zyprexa-Oral Initial or Prolonged Disease Professional (Olanzapine) Maternal Drugs Affecting Company (Olanzapine) PS Foetus Representative Neonatal Disorder Date:06/24/03ISR Number: 4135640-0Report Type:Expedited (15-DaCompany Report #EWC021032825 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Olanzapine-Oral Initial or Prolonged Laboratory Test Abnormal Health (Olanzapine) PS 5 MG/DAY Parkinsonism Professional Fluvoxamine C Quadriplegia Other En(Delorazepam) C Rhabdomyolysis Urosepsis Date:06/24/03ISR Number: 4135672-2Report Type:Expedited (15-DaCompany Report #USA030537629 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Consumer Zyprexa-Oral PS 2.5 MG/DAY 2 DAY Hallucination Remeron SS Restlessness Haldol SS Speech Disorder Date:06/24/03ISR Number: 4135843-5Report Type:Expedited (15-DaCompany Report #USA030638880 Age:11 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Blood Glucose Increased Blood Ketone Body Present Diabetes Mellitus Gastritis 24-Jun-2005 12:19 PM Page: 2350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa - Oral Professional (Olanzapine) (Olanzapine) PS 2.5 MG/2 DAY Date:06/24/03ISR Number: 4135845-9Report Type:Expedited (15-DaCompany Report #USA030638917 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Health Zyprexa - Oral Initial or Prolonged Hyperhidrosis Professional (Olanzapine) Oral Soft Tissue Disorder (Olanzapine) PS 20 MG/DAY 3 MON Rash Erythematous Haldol (Haloperidol) C Tachycardia Date:06/24/03ISR Number: 4135849-6Report Type:Expedited (15-DaCompany Report #USA030638927 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa - Oral Hospitalization - Somnolence (Olanzapine) ( Initial or Prolonged Olanzapine) PS 10 MG/M2 DAY Exelon (Rivastigme Tartrate) C Neurontin (Gabapentin) C Norvasc (Amlodipine Besilate) C Aspirin C Vitamin E C Vitamin B C Date:06/24/03ISR Number: 4135854-XReport Type:Expedited (15-DaCompany Report #US_030695165 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa - Oral Other Diabetes Mellitus Professional (Olanzapine) Diabetic Ketoacidosis Company (Olanzapine) PS Representative Antidepressant C Date:06/24/03ISR Number: 4135865-4Report Type:Expedited (15-DaCompany Report #US_030695107 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Health Strattera Blood Ph Decreased Professional (Atomoxetine Confusional State Company Hydrochloride) PS Dry Mouth Representative Zyprexa - Oral Unevaluable Event (Olazapine) ( Olanzapine) SS 30 MG/DAY 2 YR Clonazepam C 24-Jun-2005 12:19 PM Page: 2351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/03ISR Number: 4136444-5Report Type:Expedited (15-DaCompany Report #03P-056-0221590-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Depakote (Divalproex Initial or Prolonged Disturbance In Attention Health Sodium) (Divalproex Hypotonia Professional Sodium) PS ORAL 500 MG, 4 IN 1 D, ORAL Mepronizine SS ORAL 410 MG, 1 IN 1 D, ORAL Olanzapine SS ORAL 1 DOSAGE FORMS, 1 IN 1 D, ORAL Clonazepam SS ORAL 2 MG, 1 IN 1 D, ORAL Cyamemazine SS ORAL 40 MG, 1 IN 1 D, ORAL Verapamil Hydrochloride C Date:06/25/03ISR Number: 4141642-0Report Type:Periodic Company Report #USA030537782 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Strattera Increased Appetite Health (Atomoxetine Prescribed Overdose Professional Hydrochloride) PS 30 MG/ DAY Sedation Zyprexa-Oral Somnolence (Olanzapine) (Olanzapine) SS 2.5 MG/ 2 DAY Date:06/25/03ISR Number: 4141644-4Report Type:Periodic Company Report #USA030537107 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Consumer Strattera Initial or Prolonged Hallucination, Auditory (Atomoxetine Tremor Hydrochloride) PS 25 MG DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS Allegra (Fexofenadine Hydrochloride) C Eskalith (Lithium Carbonate) C Insulin C Microgestin Fe C Pancrease Microtabs C Paxil (Paroxetine Hydrochloride) C Date:06/25/03ISR Number: 4150836-XReport Type:Periodic Company Report #USA030331082 Age:40 YR Gender:Female I/FU:I Outcome PT Dizziness Fatigue Hypoaesthesia 24-Jun-2005 12:19 PM Page: 2352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Somnolence Report Source Product Role Manufacturer Route Dose Duration Consumer Strattera (Atomoxetine Hydrochloride) PS 80 MG/DAY Zyprexa-Oral (Olanzapine) (Onlanzapine) SS 20 MG/DAY Paxil (Paroxetine Hydrochloride) C 25 MG/DAY Wellbutrin (Bupropion Hydrochloride) C 400 MG/DAY Trileptal (Oxcarbazepine) C 1200 MG/DAY Date:06/25/03ISR Number: 4151639-2Report Type:Periodic Company Report #USA030331798 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Strattera Mania (Atomoxetine Hydrochloride) PS 2.5 MG Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Zyprexa-Oral (Olanzapine) (Olanzapine) SS Seroquel (Quetiapine Fumarate) C Trileptal (Oxcarbazepine) C Aripiprazole C Date:06/25/03ISR Number: 4152628-4Report Type:Periodic Company Report #USA030331676 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Strattera Sedation Professional (Atomoxetine Company Hydrochloride) PS 25 MG Representative Olanzapine-Oral (Olanzapine) SS ORAL Lithobid (Lithium Carbonate) C Date:06/25/03ISR Number: 4153256-7Report Type:Periodic Company Report #USA030331502 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Strattera Prescribed Overdose (Atomoxetine Psychomotor Hyperactivity Hydrochloride) PS 36 MG/DAY Psychotic Disorder Zyprexa-Oral (Olanzapine) 24-Jun-2005 12:19 PM Page: 2353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS 5 MG/DAY Seroquel (Quetiapine Fumarate) C Date:06/25/03ISR Number: 4153516-XReport Type:Periodic Company Report #USA030433222 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Nausea (Olanzapine) Somnolence (Olanzapine) PS 2.5 MG/AT BEDTIME Strattera (Atomoxetine Hydrochloride) SS 40 MG/DAY 2 WK Concerta (Methylphenidate Hydrochloride) C Date:06/25/03ISR Number: 4153608-5Report Type:Periodic Company Report #USA030433285 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Strattera Increased Appetite (Atomoxetine Mania Hydrochloride) PS 80 MG/DAY Weight Increased Zyprexa - Oral (Olanzapine) (Olanzapine) SS ORAL 2.5 MG Seroquel C Date:06/25/03ISR Number: 4156813-7Report Type:Periodic Company Report #USA030435367 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Consumer Strattera Impulsive Behaviour (Atomoxetine Insomnia Hydrochloride) PS 40 MG/IN THE MORNING Zyprexa Zydis-Oral (Olanzapine) (Olanzapine) SS ORAL 10 MG/IN THE EVENING Paxil (Paroxetine Hydrochloride) C Date:06/25/03ISR Number: 4156819-8Report Type:Periodic Company Report #USA030435388 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Strattera Fatigue (Atomoxetine Feeling Abnormal Hydrochloride) PS 40 MG/DAY Hypersomnia Zyprexa-Oral Infection (Olanzapine) Personality Change (Olanzapine) SS ORAL 2.5 MG/DAY Valproic Acid C 24-Jun-2005 12:19 PM Page: 2354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/03ISR Number: 4157957-6Report Type:Periodic Company Report #USA030332770 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Strattera Middle Insomnia (Atomoxetine Prescribed Overdose Hydrochloride) PS 120 MG/3 DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 60 MG/DAY Zyprexa (Olanzapine) (Olanzapine) SS Klonopin (Clonazepam) C Seroquel (Quetiapine Fumarate) C Date:06/25/03ISR Number: 4158995-XReport Type:Periodic Company Report #USA030434545 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Strattera Drug Ineffective Professional (Atomoxetine Prescribed Overdose Company Hydrochloride) PS 18 MG/2 DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/DAY Date:06/25/03ISR Number: 4160775-6Report Type:Periodic Company Report #USA030332040 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Health Strattera Professional (Atomoxetine Company Hydrochloride) PS 60 MG/DAY Representative Zyprexa - Oral (Olanzapine) (Olanzapine) SS 10 MG/DAY Orap (Pimozide) C Adderall C Date:06/25/03ISR Number: 4160781-1Report Type:Periodic Company Report #USA03032114 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Strattera Sleep Walking (Atomoxetine Hydrochloride) PS 40 MG/DAY Zyprexa - Oral (Olanzapine) (Olanzapine) SS 12.5 MG/DAY Lithium C 24-Jun-2005 12:19 PM Page: 2355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/03ISR Number: 4161509-1Report Type:Periodic Company Report #USA030330925 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Strattera(Atomoxetin Irritability e Hydrochloride) PS 30 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 7 MG/DAY Ritalin-Sr (Methylphenidate Hydrochloride) C Date:06/25/03ISR Number: 4161545-5Report Type:Periodic Company Report #USA030330767 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Strattera Pyrexia (Atomoxetine Skin Discolouration Hydrochloride) PS 18 MG/DAY Urticaria Zyprexa-Oral (Olanzapine) (Olanzapine) SS 1.25 MG/AT BEDTIME Wellbutrin(Bupropion Hydrochloride) C Benadryl(Diphenhydra mine Hydrochloride) C Prednisolone C Date:06/25/03ISR Number: 4161623-0Report Type:Periodic Company Report #USA030330735 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Consumer Strattera (Atomoxetine Hydrochloride) PS 60 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/AT BEDTIME Clonidine C Date:06/25/03ISR Number: 4162635-3Report Type:Periodic Company Report #USA030229051 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Strattera Insomnia (Atomoxetine Muscle Spasms Hydrochloride) PS 40MG/1 DAY 4 DAY Pain In Extremity Zyprexa (Olanzapine) SS 2.5 MG/2 DAY 9 MON Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40MG/DAY Neurontin (Gabapentin) C 24-Jun-2005 12:19 PM Page: 2356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/03ISR Number: 4162689-4Report Type:Periodic Company Report #US97011525A Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Consumer Strattera Malaise Health (Atomoxetine Nausea Professional Hydrochloride) PS 80 MG/DAY Pruritus Zyprexa Rash (Olanzapine) SS ORAL 5 MG/1 DAY Somnolence Imipramine C Weight Decreased Ritalin(Methylphenid Weight Increased ate Hydrochloride) C Catapres (Clinidine) C Zoloft (Sertraline Hydrochloride) C Date:06/25/03ISR Number: 4162925-4Report Type:Periodic Company Report #USA030332659 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activities Of Daily Consumer Strattera Living Impaired (Atomoxetine Aggression Hydrochloride) PS 25 MG/DAY Asthenia Zyprexa-Oral Dizziness (Olanzapine) Fatigue (Olazapine) SS 2.5 MG/DAY Malaise Somnolence Date:06/25/03ISR Number: 4163404-0Report Type:Periodic Company Report #USA030229616 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Health Strattera Neck Pain Professional (Atomoxetine Neurological Symptom Hydrochloride) PS 40 MG Zyprexa-Oral (Olanzapine) (Olanzapine) SS Concerta (Methylphenidate Hydrochloride) C Risperdal (Risperidone) C Date:06/25/03ISR Number: 4163430-1Report Type:Periodic Company Report #USA030229734 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Strattera Crying (Atomoxetine Screaming Hydrochloride) PS 60 MG/IN THE EVENING Zyprexa-Oral (Olanzapine)(Olanzap ine) SS Adderall C Adderall Xr C Benadryl 24-Jun-2005 12:19 PM Page: 2357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Diphenhydramine Hydrochloride) C Imipramine C Clonidine C Tenex (Guanfacine Hydrochloride) C Date:06/25/03ISR Number: 4165710-2Report Type:Periodic Company Report #USA030433672 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Consumer Forteo Depression (Teriparatide) PS 20 UG/DAY Disturbance In Attention Zyprexa (Olanzapine SS ORAL 5 MG/DAY Injection Site Cozaar C Haemorrhage Lithium C Weight Decreased Pepcid(Famotidine) C Primidone C Synthroid (Levothyroxine Sodium) C Zocor(Simvastatin) C Date:06/25/03ISR Number: 4166403-8Report Type:Periodic Company Report #USA030229556 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Forteo Dyspepsia (Teriparatide) PS 20 UG /DAY Fear Zyprexa-Oral (Olanzapine) SS ORAL Centrum C Citracal (Calcium Citrate) C Estrogen Nos C Fibercon (Polycarbophil Calcium) C Folic Acid C Klonopin (Clonazepam) C Maxide C Paxil (Paroxetine Hydrochloride) C Protonix (Pantoprazole) C Bran C Stool Softener (Docusate Sodium) C Vitamin B1 C Vitamin B12 C Vitamin E C Zestril (Lisinopril) C Vitamin C C 24-Jun-2005 12:19 PM Page: 2358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/03ISR Number: 4137515-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Risperidone Initial or Prolonged Aspartate Health (Risperidone) Aminotransferase Professional Unspecified PS Blood Alkaline Perphenazine Phosphatase (Perphenazine) SS Blood Bicarbonate Olanzapine Blood Calcium (Olanzapine) SS Blood Chloride Quetiapine Blood Creatine (Quetiapine) SS Phosphokinase Ziprasidone Blood Creatine (Ziprasidone) SS Phosphokinase Mb Clonazepam () Blood Creatinine Clonazepam C Blood Glucose Mirtazapine () Blood Magnesium Mirtazapine C Blood Ph Increased Catopril () Blood Potassium Captopril C Blood Sodium Glipizide () Dyspnoea Glipizide C Electrocardiogram T Wave Abnormal Glucose Urine Present Haemoglobin Mental Disorder Oxygen Saturation Decreased Pco2 Po2 Protein Total Pulmonary Congestion Pulmonary Vascular Disorder Red Blood Cells Urine Positive Sinus Tachycardia Thirst Urine Ketone Body Present White Blood Cells Urine Positive Date:06/27/03ISR Number: 4138871-9Report Type:Expedited (15-DaCompany Report #2002-DE-02258GD Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokalaemia Literature Methadone Required Syncope (Methadone) PS 65 MG 2 MON Intervention to Torsade De Pointes Olanzapine Prevent Permanent (Antipsychotics) SS Impairment/Damage Date:06/27/03ISR Number: 4138887-2Report Type:Expedited (15-DaCompany Report #2002-DE-02246GD Age:50 YR Gender:Male I/FU:F Outcome Other Required 24-Jun-2005 12:19 PM Page: 2359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Literature Methadone Corrected Interval (Methadone) PS 1000 MG 12 MON Prolonged Olanzapine Electrocardiogram Qt (Antipsychotics) SS Prolonged Syncope Torsade De Pointes Date:06/30/03ISR Number: 4137206-5Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041217A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Quilonum PS Glaxosmithkline ORAL 3TAB Single No Adverse Drug Effect Professional dose 1 DAY Suicide Attempt Zyprexa SS ORAL 10TAB Single dose 1 DAY Date:06/30/03ISR Number: 4138098-0Report Type:Direct Company Report #CTU 196918 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Zyprexa 10 Mg Lilly PS Lilly ORAL 20 MG ONCE A Drug Withdrawal Syndrome DAY ORAL Feeling Abnormal Zoloft 100 Mg Pfizer SS Pfizer ORAL 100 MG ONCE A Heart Rate Increased DAY ORAL Illusion Panic Reaction Visual Disturbance Date:06/30/03ISR Number: 4146722-1Report Type:Periodic Company Report #USA030228323 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Blood Glucose Increased (Olanzapine) Other Diabetes Mellitus (Olanzapine) PS 20 MG/DAY Furuncle Humulin-Human Nph Pancreatitis Insulin (Rdna) Weight Increased (Human Insulin (Rd SS Humalog-. (Lispro) SS Temazepam C Remeron (Mirtazapine) C Trazodone C Celexa (Citalopram Hydrobromide) C Wellbutrin (Bupropion Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/03ISR Number: 4148626-7Report Type:Periodic Company Report #2002066465 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Sertraline Professional (Sertraline) PS ORAL 200 MG (BID), ORAL Bupropion Hydrochloride (Bupropion Hydrochloride) SS ORAL 300 MG (BID), ORAL Olanzapine (Olanzapine) SS ORAL 5 MG (BID), ORAL Allegra-D (Pseudoephedrine Hydrochloride, Fexofenadine) SS ORAL (BID), ORAL Minocycline (Minocycline) SS 200 MG (BID Date:06/30/03ISR Number: 4164280-2Report Type:Periodic Company Report #US_990319499 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Humulin-Human Lente Initial or Prolonged Blood Glucose Decreased Insulin (Rdna) Blood Glucose Increased (Human Insulin PS 34 U/DAY Compulsions Humulin-Human Hyperglycaemia Regular Insulin Hypoglycaemia (Rdna) (Human Scar Insulin SS Sedation Iletin-Insulin-Anima Skin Ulcer l (Unknown Surgery Formulation) (Insuli SS Urinary Tract Infection Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/DAY Humalog-.(Lispro) SS 28 U/DAY Humulin-Human Insulin (Rdna) : 50% Regular, 50% Nph (H SS Humulin-Human Insulin (Rdna) : 30% Regular, 70% Nph (H SS Klonopin (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Lexapro (Escitalopram) C Date:07/01/03ISR Number: 4138847-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279857 Age:1 DY Gender:Female I/FU:F Outcome PT Congenital Anomaly Atrial Septal Defect Other Maternal Drugs Affecting Foetus 24-Jun-2005 12:19 PM Page: 2361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maternal Use Of Illicit Drugs Report Source Product Role Manufacturer Route Dose Duration Health Videx Ec Caps 400 Mg PS Bristol-Myers Squibb Professional Company TRANSPLACENTAL Received from week 16 of gestation until delivery. Viracept SS TRANSPLACENTAL Received from week 16 of gestation until delivery. Retrovir SS TRANSPLACENTAL Haldol SS TRANSPLACENTAL Zyprexa SS TRANSPLACENTAL during the 1st trimester Date:07/01/03ISR Number: 4139893-4Report Type:Direct Company Report #CTU 197062 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Zyprexa (2.5-10mg/D) PS 25-10MG/D Intervention to Prevent Permanent Impairment/Damage Date:07/01/03ISR Number: 4139945-9Report Type:Direct Company Report #CTU 197044 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Zyprexa 10mg PS ONE QHS 3 YR Insomnia Artane C Paraesthesia Ativan C Tremor Glyburide C Date:07/01/03ISR Number: 4140337-7Report Type:Expedited (15-DaCompany Report #USA030639815 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Strattera Professional (Atomoxetine Company Hydrochloride) PS 80 MG/AT Representative BEDTIME Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 80 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG/AT BEDTIME Adderall Xr C Nexium (Esomeprazole) C 24-Jun-2005 12:19 PM Page: 2362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/03ISR Number: 4140457-7Report Type:Expedited (15-DaCompany Report #USA030536357 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zyprexa-Oral Blood Osmolarity Professional (Olanzapine) Blood Sodium Company (Olanzapine) PS 20 MG/AT Blood Urea Representative BEDTIME Dehydration Geodon (Ziprasidone Diabetes Mellitus Hydrochloride) C Hyperosmolar State Depakote (Valproate Pancreatitis Semisodium) C Pco2 Seroquel (Quetiapine Urine Ketone Body Fumarate) C Weight Increased Date:07/01/03ISR Number: 4140458-9Report Type:Expedited (15-DaCompany Report #USA030537151 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa-Oral Multiple Drug Overdose Professional (Olanzapine) Company (Olanzapine) PS 260 MG Representative Xanax (Alprazolam) C Oxycontin (Oxycodone Hydrochloride) C Date:07/01/03ISR Number: 4140482-6Report Type:Expedited (15-DaCompany Report #DE_021210370 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Zyprexa-Oral Initial or Prolonged Granulocytopenia Health (Olanzapine) Rhabdomyolysis Professional (Olanzapine) PS 5 MG/1 DAY Other Citalopram C Lorazepam C Date:07/01/03ISR Number: 4140499-1Report Type:Expedited (15-DaCompany Report #2003026108 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Zyrtec (Tablets) Hospitalization - Calculus Bladder Health (Cetirizine) PS ORAL 10 MG ORAL Initial or Prolonged Leukocytosis Professional Haloperidol Other Pancreatitis Acute (Haloperidol) SS ORAL ORAL Renal Failure Propranolol (Propranolol) SS ORAL ORAL Paracetamol (Paracetamol) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL 5 MG ORAL Troxerutin (Troxerutin) SS ORAL 1000 MG ORAL 24-Jun-2005 12:19 PM Page: 2363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/03ISR Number: 4140636-9Report Type:Expedited (15-DaCompany Report #USA030639620 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Prozac-Oral(Fluoxeti Initial or Prolonged Coma ne) (Fluoxetine Other Communication Disorder Hydrochloride) PS 20 MG/IN THE Fall MORNING Head Injury Zyprexa-Oral Hypertension (Olanzapine) SS 10 MG/AT Inadequate Diet BEDTIME Incontinence Coumadin (Warfarin Insomnia Sodium) C Laceration Fosamax (Alendroante Sodium) C Miralax (Macrogol) C Vasotec (Enalapril Maleate) C Date:07/01/03ISR Number: 4140804-6Report Type:Expedited (15-DaCompany Report #CA_030606033 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa Hospitalization - Agitation Health Zydis-Dispersible Initial or Prolonged Arrhythmia Professional (Olanzapine) Confusional State Company (Olanzapine) PS 20 MG Hostility Representative Muscle Rigidity Other Pyrexia Date:07/01/03ISR Number: 4140807-1Report Type:Expedited (15-DaCompany Report #EWC030635151 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG/DAY Professional Zopiclone C Company Gtn C Representative Flupentixol Other Decanoate C Amoxycillin C Vitamin B Complex C Ventolin(Salbutamol) C Losec(Omeprazole) C Clonazepam C Diastop C Panadeine C Date:07/01/03ISR Number: 4140812-5Report Type:Expedited (15-DaCompany Report #EWC030635088 Age:76 YR Gender:Male I/FU:I Outcome PT Other Hyperthermia Malignant Metabolic Acidosis Psychomotor Agitation Renal Failure Respiratory Failure Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 2364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sopor Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG/DAY Professional Paroxetine C Other Alprazolam C Ticlopidine C Date:07/01/03ISR Number: 4140833-2Report Type:Expedited (15-DaCompany Report #EWC030635231 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Infection Foreign Zyprexa-Oral Hospitalization - Neuroleptic Malignant Health (Olanzapine) Initial or Prolonged Syndrome Professional (Olanzapine) PS 10 MG/UNKNOWN Viral Infection Company Prozac (Fluoxetine Representative Hydrochloride) C Edronax (Reboxetine) C Fluzepam (Flurazepam Hydrochloride) C Apaurin C Date:07/01/03ISR Number: 4140839-3Report Type:Expedited (15-DaCompany Report #FR_030602559 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-Oral Initial or Prolonged International Normalised Health (Olanzapine) Ratio Decreased Professional (Olanzapine) PS 15 MG/DAY Phlebitis Levothyrox White Blood Cell Count (Levothyroxine Decreased Sodium) Hypothyroidism C Aspegic (Acetylsalicylate Lysine) Phlebitis C Mopral (Omeprazole) Ulcer C Transipeg (Macrogol) Constipation C Fraxodi (Nadroparin Calcium) Phlebitis C Previscan (Fluindione) Phlebitis C Date:07/01/03ISR Number: 4140843-5Report Type:Expedited (15-DaCompany Report #FR_030602569 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Foreign Zyprexa-Oral Initial or Prolonged Electrocardiogram Qt Health (Olanzapine) Prolonged Professional (Olanzapine) PS 1 DSG Other FORM/DAY Mepronizine C Tercian (Cyamemazine) C 24-Jun-2005 12:19 PM Page: 2365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Isoptine (Verapamil Hydrochloride) C Depakote (Valproate Semisodium) C Rivotril (Clonazepam) C Date:07/01/03ISR Number: 4140844-7Report Type:Expedited (15-DaCompany Report #GBS030613281 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aphasia Foreign Olanzapine- Oral Asthenia Health (Olanzapine) PS 15 MG/UNKNOWN Dysphasia Professional Bendrofluazide C Other Enalapril C Date:07/01/03ISR Number: 4140845-9Report Type:Expedited (15-DaCompany Report #GBS030613228 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Olanzapine- Oral Initial or Prolonged Fall Health (Olanzapine) PS 10 MG/1 DAY Head Injury Professional Thyroxine C Loss Of Consciousness Other Warfarin C Flecainide C Loratadine C Pizotifen C Salbutamol C Salmeterol C Atrovent (Ipratropium Bromide) C Sodium Cromoglycate C Date:07/01/03ISR Number: 4140996-9Report Type:Expedited (15-DaCompany Report #DE_030611520 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Foreign Zyperxa Velotab-Oral Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS 20 MG/DAY Chills Company Cipramil (Citalopram Confusional State Representative Hydrobromide) C Dyskinesia Other Rivotril(Clonazepam) C Dyspnoea Tavor (Lorazepam) C Hyperhidrosis Ximovan (Zopiclone) C Myoglobin Blood Increased Tachycardia Tachypnoea Date:07/01/03ISR Number: 4141000-9Report Type:Expedited (15-DaCompany Report #JP_030601146 Age: Gender:Male I/FU:I Outcome PT Other Anaemia Diabetes Mellitus Difficulty In Walking 24-Jun-2005 12:19 PM Page: 2366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Large Intestine Carcinoma Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 5 MG/DAY Professional Serenace Other (Haloperidol) C Contomin (Chlorpromazine Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Bezalip (Bezafibrate) C Norvasc (Amlodipine Besilate) C Eurodin (Estazolam) C Date:07/02/03ISR Number: 4141563-3Report Type:Expedited (15-DaCompany Report #HQWYE797930JUN03 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congenital Hand Foreign Efexor (Venlafaxine Malformation Health Hydrochloride, Maternal Drugs Affecting Professional Tablet) PS ORAL 75 MG 1 X PER Foetus Other 1 DAY Alprazolam (Alprazolam) SS ORAL 40 MG 1 X PER 1 TOT Nefadar (Nefazodone Hydrochloride) SS ORAL "200-100" DAILY Ponstan (Mefenamic Acid,) SS ORAL "OCCASIONALLY (4-5 TIME/MONTH)" Prazine (Promazine Hydrochloride, Tablet) SS ORAL 50 MG 1 X PER 1 TOT 1 DAY Primperan (Metoclopramide,) SS ORAL 10 MG 1 X PER 1 DAY 23 DAY Seresta (Oxazepam, Tablet) SS ORAL 30 MG 1 X PER 1 DAY 55 DAY Topamax (Topiramate) SS ORAL "200-100 MG" DAILY 55 DAY Trittico (Trazodone Hydrochloride) SS ORAL "50-100 MG" DAILY Zyprexa (Olanzapine, ) SS ORAL 2.5 MG 1 X PER 1 DAY 24-Jun-2005 12:19 PM Page: 2367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/03ISR Number: 4146911-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030602437 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperidone Hospitalization - Cerebral Atrophy Health (Risperidone) Initial or Prolonged Circulatory Collapse Professional Tablets PS ORAL ORAL Drug Abuser Olanzapine Feeling Abnormal (Olanzapine) Tablets SS ORAL ORAL Gait Disturbance Amezinium Hallucination, Auditory Metisulfate Ventricular Fibrillation (Amezinium Metilsulfate) Tablets SS ORAL 20 MG, 1 IN 1 DAY, ORAL Dimeticone (Tablets) Dimeticone C Cetilo (Tablets) All Other Therapeutic Products C Vegetamin-A (Vegetamin A) Tablets C Brotizolam (Brotizolam) Tablets C Itropride Hydrochloride (Itopride Hydrochloride) C Sennoside (All Other Therapeutic Products) Tablets C Haloperidol (Haloperidol) Tablets C Senna Extract (Senna Liquid Extract) Tablets C Date:07/03/03ISR Number: 4141453-6Report Type:Direct Company Report #CTU 197225 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa Eli Lilly PS Eli Lilly BUCCAL 1 TAB DAILY Disability Insulin-Dependent BUCCAL Ketoacidosis Date:07/07/03ISR Number: 4142140-0Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0302485A Age:38 YR Gender:Male I/FU:F Outcome PT Life-Threatening Atrioventricular Block Hospitalization - Bradycardia Initial or Prolonged Coma Convulsion Drug Ineffective Intentional Misuse Pyrexia Suicide Attempt Supraventricular 24-Jun-2005 12:19 PM Page: 2368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Zyban PS Glaxosmithkline ORAL 12G Single Professional dose 1 DAY Zyprexa SS ORAL 80TAB Single dose Imovane SS ORAL Date:07/07/03ISR Number: 4143067-0Report Type:Direct Company Report #CTU 197293 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anion Gap Zyprexa 10mg Lilly PS Lilly ORAL 10MG QD PRN Hospitalization - Blood Glucose Increased ORAL Initial or Prolonged Ketoacidosis Required Polydipsia Intervention to Polyuria Prevent Permanent Impairment/Damage Date:07/07/03ISR Number: 4144669-8Report Type:Expedited (15-DaCompany Report #2003027467 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Lithium (Lithium) PS 900 MG Initial or Prolonged Increased Literature Haloperidol Apathy Health (Haloperidol) SS 4.5 MG Aspartate Professional Olanzapine Aminotransferase (Olanzapine) SS Increased Valproate Semisodium Blood Creatine (Valproate Phosphokinase Increased Semisodium) C Blood Sodium Decreased Clonazepam Blood Urea Increased (Clonazepam) C Catatonia Carbamazepine Echolalia (Carbamazepine) C Echopraxia Thioridazine Extensor Plantar Response (Thioridazine) C Haemoglobin Decreased Hyperreflexia Monocyte Count Decreased Movement Disorder Muscle Rigidity Myalgia Negativism Neuroleptic Malignant Syndrome Neutrophil Count Increased Pyrexia Red Blood Cell Count Decreased Somnolence Tachycardia Urinary Retention White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4143271-1Report Type:Direct Company Report #CTU 197450 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel PS ORAL 25 MG BID Syndrome ORAL Zyprexa SS ORAL 2.5 MG BID ORAL Date:07/08/03ISR Number: 4144927-7Report Type:Expedited (15-DaCompany Report #M0691-2003 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Mirtazapine PS ORAL SEE IMAGE 75 DAY Initial or Prolonged Potentiation Professional Venlafaxine Hepatic Failure Hydrochloride SS ORAL SEE IMAGE 16 DAY Olanzapine SS ORAL SEE IMAGE 98 DAY Nefazodone Hydrochloride C Zopiclone C Levothyroxine Sodium C Tetrazepam C Lactulose C Date:07/08/03ISR Number: 4145102-2Report Type:Expedited (15-DaCompany Report #2003144872CH Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Congenital Hand Foreign Xanax(Alprazolam) Congenital Anomaly Malformation Health Tablet, 2mg PS ORAL 2 MG/DAY, Drug Exposure During Professional ORAL Pregnancy Other Seresta(Oxazepam) Maternal Drugs Affecting Tablet, 15mg SS ORAL 30 MG, QD, Foetus ORAL Zyprexa(Olanzapine) Tablet, 2.5mg SS ORAL 2.5 MG, QD, ORAL Nefadar (Nefazodone Hydrochloride) Tablet SS ORAL 200 00 MG/DAY, ORAL : 100 MG/DAY ORAL Topamax(Topiramate) Tablet SS ORAL 20 MG/DAY, ORAL : 100 MG/DAY Mefenamic Acid C Trittico C Entumin (Clotiapine) C Primperan C Prazine (Promazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145153-8Report Type:Expedited (15-DaCompany Report #M0689-2003 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Health Mirtazapine PS ORAL 30 MG/45 MG 1 DAY Initial or Prolonged Decreased Professional Venlafaxine Delirium Hydrochloride SS ORAL 150 MG/75 Disorientation MG/150 MG 2 DAY Drug Interaction Olanzapine SS ORAL 5 MG Heart Rate Increased Lorazepam C Restlessness Risperidone C Speech Disorder White Blood Cell Count Date:07/08/03ISR Number: 4145159-9Report Type:Expedited (15-DaCompany Report #M0688-2003 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Mirtazapine PS ORAL 60 MG/ 45 MG/ Initial or Prolonged Depression Professional 30 MG/ 45 MG 13 DAY Liver Function Test Venlafaxine Abnormal Hydrochloride SS ORAL 75 MG/ 150 MG/ 225 MG/150 MG/ 75 MG 13 DAY Olanzapine SS ORAL 2.5 MG/ 5 MG/ 7.5 MG 11 DAY Lorazepam C Date:07/08/03ISR Number: 4145328-8Report Type:Expedited (15-DaCompany Report #S03-GER-02749-01 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Urinary Retention Health Hydrobromide) PS ORAL 20 MG QD PO Weight Increased Professional Cipramil (Citalopram Other Hydrobrmoide) SS ORAL 40 MG QD PO Taxilan (Perazine0 SS ORAL 75 MG PO Zyprexa(Olanzapine) SS ORAL 10 MG PO Zyprexa (Olanzapine) SS ORAL 15 MG PO Zyprexa (Olanzapine) SS ORAL 20 MG PO Zyprexa(Olanzapine) SS ORAL 25 MG QD PO Date:07/08/03ISR Number: 4145507-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acute Respiratory Initial or Prolonged Distress Syndrome Alanine Aminotransferase Aspartate Aminotransferase Blood Alkaline Phosphatase Blood Bicarbonate Blood Calcium Blood Chloride Blood Creatine Blood Creatine 24-Jun-2005 12:19 PM Page: 2371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Blood Creatine Phosphokinase Mb Blood Glucose Report Source Product Role Manufacturer Route Dose Duration Blood Magnesium Study Risperidone Blood Urine Health (Risperidone) Chest X-Ray Abnormal Professional Unspecified PS Dyspnoea Perphenazine Electrocardiogram T Wave (Perphenazine) SS Abnormal Olanzapine Glucose Urine Present (Olanzapine) SS Haematocrit Decreased Quetiapine Haemoglobin (Quetiapine) SS Hypokalaemia Ziprasidone Hyponatraemia (Ziprasidone) SS Mental Disorder Clonazepam C Pco2 Decreased Mirtazapine C Po2 Decreased Catopril C Polydipsia Psychogenic Glipizide C Protein Total Pulmonary Congestion Respiratory Failure Sinus Tachycardia Thirst Troponin White Blood Cells Urine Positive Date:07/09/03ISR Number: 4143535-1Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12119814 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Congenital Hand Nefadar Tabs PS Bristol-Myers Squibb Congenital Anomaly Malformation Company TRANSPLACENTAL started 200mg Other Drug Exposure During daily, then Pregnancy dose decreased to 100mg daily Trittico SS Apothecon TRANSPLACENTAL 50-100 mg daily Alprazolam SS TRANSPLACENTAL Topamax SS TRANSPLACENTAL 100mg-200mg daily Seresta SS TRANSPLACENTAL 14-Jun-02-alr eady the 59 th day post-concepti on Zyprexa SS TRANSPLACENTAL Effexor C TRANSPLACENTAL (25-Jul-02-st art date-already 100th day post-concepti Mefenamic Acid C TRANSPLACENTAL dose 2000-2500 mg/month if needed Entumine C TRANSPLACENTAL 104th day post-concepti on 24-Jun-2005 12:19 PM Page: 2372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Primperan C TRANSPLACENTAL 85th to 111th day post-concepti on Date:07/09/03ISR Number: 4143795-7Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041217A Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Health Quilonum PS Glaxosmithkline ORAL 3TAB Single Initial or Prolonged Suicide Attempt Professional dose 1 DAY Zyprexa SS ORAL 10TAB Single dose 1 DAY Date:07/09/03ISR Number: 4146009-7Report Type:Expedited (15-DaCompany Report #US_030393671 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Alanine Aminotransferase (Olanzapine) Increased (Olanzapine) PS Aspartate Aminotransferase Increased Blood Calcium Decreased Blood Urea Decreased Diabetes Mellitus Inadequate Control Diarrhoea Haemorrhagic Drug Ineffective Endometriosis Flank Pain Hepatic Steatosis Liver Scan Abnormal Nausea Nephrolithiasis Vaginal Mycosis Vomiting Date:07/09/03ISR Number: 4146126-1Report Type:Expedited (15-DaCompany Report #USA030536357 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa-Oral Blood Ph Decreased Professional (Olanzapine) Blood Sodium Company (Olanzapine) PS 20 MG/AT Blood Urea Representative BEDTIME Dehydration Geodon (Ziprasidone Diabetes Mellitus Hydrochloride) C Drug Level Increased Depakote (Valproate Hyperosmolar State Semisodium) C Pancreatitis Urine Ketone Body Weight Increased 24-Jun-2005 12:19 PM Page: 2373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/03ISR Number: 4146136-4Report Type:Expedited (15-DaCompany Report #USA030435627 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Klonopin (Clonazepam) C Celexa (Citalopram Hydrobromide) C Tylenol With Codeine C Date:07/09/03ISR Number: 4146245-XReport Type:Expedited (15-DaCompany Report #USA030639936 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Paxil (Paroxetine Hydrochloride) C Soma (Carisoprodol) C Trazadone (Trazadone) C Date:07/09/03ISR Number: 4146384-3Report Type:Expedited (15-DaCompany Report #US_030695165 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Chloride Health Zyprexa-Oral Other Blood Creatinine Professional (Olanzapine) Blood Potassium Company (Olanzapine) PS 25 MG Blood Sodium Representative Effexor-Xr Blood Urea (Venlafaxine Dehydration Hydrochloride) C Diabetes Mellitus Trazodone C Diarrhoea Albuterol C Emphysema Liver Disorder Nausea Toxicologic Test Abnormal Vomiting Weight Decreased Weight Increased Date:07/09/03ISR Number: 4146473-3Report Type:Expedited (15-DaCompany Report #EWC030434425 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Zyprexa-Oral Hospitalization - Pneumonia Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS Company Representative Other 24-Jun-2005 12:19 PM Page: 2374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/03ISR Number: 4146565-9Report Type:Expedited (15-DaCompany Report #USA030640128 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Malignant Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Haldol (Haloperidol) C Date:07/09/03ISR Number: 4146567-2Report Type:Expedited (15-DaCompany Report #USA030639984 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Hyperpyrexia Professional (Olanzapine) Kidney Infection Company (Olanzapine) PS 5 MG/DAY Representative Strattera (Atomoxetine Hydrochloride) SS 40 MG/2 DAY Norpramin (Desipramine Hydrochloride) C Desyrel (Trazodone Hydrochloride) C Xanax (Alprazolam) C Norco C Hyzaar C Ziac C Anaspaz (Hyoscyamine Sulfate) C Date:07/09/03ISR Number: 4146884-6Report Type:Expedited (15-DaCompany Report #EWC030735362 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Zyprexa-Oral Initial or Prolonged Liver Function Test Health (Olanazapine) Abnormal Professional (Olanazapine) PS 3.8 MG/DAY Pancreatic Enlargement Other Pancreatic Necrosis Pancreatitis Parenteral Nutrition Sepsis Tremor Urinary Retention Weight Increased Date:07/09/03ISR Number: 4146885-8Report Type:Expedited (15-DaCompany Report #GBS030613305 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Foreign Olanzapine-Oral Toxic Epidermal Health (Olanzapine) PS 12.5 MG/ Necrolysis Professional Diazepam C Other Thiamine C Atenolol C Adalat La (Nifedipine) C Depakote (Valproate 24-Jun-2005 12:19 PM Page: 2375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Risperidone C Date:07/09/03ISR Number: 4146887-1Report Type:Expedited (15-DaCompany Report #JP_030601168 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa-Oral Initial or Prolonged Overdose Health (Olanazapine) Professional (Olanazapine) PS 100 MG/DAY Company Rohypnol(Flunitrazep Representative am) C Other Akineton (Biperiden Hydrochloride) C Date:07/09/03ISR Number: 4146889-5Report Type:Expedited (15-DaCompany Report #JP_030601208 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Foreign Zyprexa-Oral Other Respiratory Arrest Health (Olanazapine) Temperature Regulation Professional (Olanazapine) PS 2.5 MG/DAY Disorder Company Permax (Pergolide Tracheostomy Representative Mesilate) C Vocal Cord Disorder Other Symmetrel (Amantadine Hydrochloride) C Levodopa Benserazide Hydrochlo C Depromel (Fluvoxamine) C Thyradin (Thyroid) C Pantosin (Pantethine) C Magnesium Oxide C Aspara K(Aspartate Potassium) C Date:07/09/03ISR Number: 4146913-XReport Type:Expedited (15-DaCompany Report #FR- JNJFOC-20030601299 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Haldol (Haloperidol) Life-Threatening Drug Interaction Health Unspecified PS ORAL ORAL Hospitalization - Neoplasm Of Appendix Professional Avlocardyl Initial or Prolonged Pancreatitis Acute (Propranolol) SS ORAL 40 MG, ORAL Renal Failure Paracetamol (Paracetamol) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL 5 MG, 1 IN 1 DAY, ORAL Zyrtec (Cetirizine Hydrochloride) SS ORAL 10 MG, ORAL Veinamitol (Troxerutin) SS ORAL 1000 MG, 1 IN 1 DAY, ORAL 24-Jun-2005 12:19 PM Page: 2376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/03ISR Number: 4146922-0Report Type:Expedited (15-DaCompany Report #EWC030534936 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Foreign Olanzapine-Oral Sudden Death Health (Olanzapine) PS 10 MG DAY Treatment Noncompliance Professional Diazepam C Ulcer Other Date:07/09/03ISR Number: 4146926-8Report Type:Expedited (15-DaCompany Report #EWC030635030 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Foreign Olanzapine-Oral Initial or Prolonged Muscle Rigidity Health (Olanzapine) PS 100 MG DAY Muscle Spasms Professional Overdose Company Somnolence Representative Speech Disorder Other Date:07/09/03ISR Number: 4146938-4Report Type:Expedited (15-DaCompany Report #EWC030635357 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Zyprexa-Oral Overdose Health (Olanzapine) Professional (Olanzapine) PS 560 MG/OTHER Other Date:07/09/03ISR Number: 4146948-7Report Type:Expedited (15-DaCompany Report #JP_030500944 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Chest X-Ray Abnormal Professional (Olanzapine) PS 10 MG DAY Drug Ineffective Company Risperdal Eosinophil Count Representative (Risperidone) C Increased Other Flunitrazepam C Fall Chinese Medicine C Femoral Neck Fracture Cefotiam C Pleural Effusion Gentamicin Sulfate C Pyrexia White Blood Cell Count Increased Date:07/09/03ISR Number: 4146972-4Report Type:Expedited (15-DaCompany Report #JP_030300564 Age:68 YR Gender:Female I/FU:F Outcome PT Death Acute Myocardial Hospitalization - Infarction Initial or Prolonged Asthenia Blood Creatine Phosphokinase Increased Blood Pressure Decreased Bradycardia Cardiac Failure 24-Jun-2005 12:19 PM Page: 2377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressed Level Of Consciousness Gait Disturbance Report Source Product Role Manufacturer Route Dose Duration Upper Respiratory Tract Foreign Olanzapine-Oral Inflammation Study (Olanzapine) PS 10 MG/1 DAY Health Mercazole(Thiamazole Professional ) C Other Limas(Lithium Carbonate) C Akineton(Biperiden Hydrochloride) C Barnetil(Sultopride) C Vegetamin B C Rhythmy(Rilmazafone) C Date:07/09/03ISR Number: 4146974-8Report Type:Expedited (15-DaCompany Report #EWC030434730 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Foreign Zyprexa-Oral Condition Aggravated Health (Olanzpine)(Olanzapi Gastrointestinal Disorder Professional ne) PS 15 MG/DAY 6 MON Mania Company Thrombosis Representative Other Date:07/09/03ISR Number: 4146975-XReport Type:Expedited (15-DaCompany Report #JP_030500880 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Overdose Consumer (Olanzapine) Company (Olanzapine) PS 35 MG/DAY Representative Lexotan(Bromazepam) C Other Tofranil(Imipramine Hydrochloride) C Tryptanol(Amitriptyl ine Hydrochloride) C Mucosta(Rebamipide) C Paxil(Paroxetine Hydrochloride) C Date:07/09/03ISR Number: 4146976-1Report Type:Expedited (15-DaCompany Report #JP_030500916 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa-Oral Back Pain Health (Olanzapine) Decreased Appetite Professional (Olanzapine) PS 15 MG/DAY Hepatic Cancer Metastatic Company Tegretol(Carbamazepi Hepatomegaly Representative ne) C Respiratory Failure Other 24-Jun-2005 12:19 PM Page: 2378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/03ISR Number: 4147381-4Report Type:Expedited (15-DaCompany Report #EMADSS2003004249 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Foreign Risperdal Initial or Prolonged Polymyositis Health (Risperidone) Rhabdomyolysis Professional Tablets PS ORAL 2 MG, ORAL Zyprexa (Olanzapine) Unspecified SS 15 MG L-Thyroxin (Levothyroxine Sodium) C Date:07/09/03ISR Number: 4147655-7Report Type:Expedited (15-DaCompany Report #JP_030601172 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Constipation Study (Olanzapine) Delusion Health (Olanzapine) PS 2.5 MG/DAY Treatment Noncompliance Professional Weight Increased Other Date:07/09/03ISR Number: 4147656-9Report Type:Expedited (15-DaCompany Report #AU_030606404 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Zyprexa-Oral Initial or Prolonged Body Temperature Consumer (Olanzapine) Increased Other (Olanzapine) PS 60 MG/DAY Coordination Abnormal Prozac C Delirium Valium (Diazepam) C Dysarthria Lithium C Feeling Abnormal White Blood Cell Count Increased Date:07/09/03ISR Number: 4147657-0Report Type:Expedited (15-DaCompany Report #DE_030611533 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Foreign Zyprexa-Oral Hospitalization - Pulmonary Embolism Health (Olanzapine) Initial or Prolonged Respiratory Failure Professional (Olanzapine) PS 10 MG/DAY Other Ergenyl (Valproate Sodium) C Edronax (Reboxetine) C Cipramil (Citalopram Hydrobromide) C Corvaton C Pantozol (Pantoprazole Sodium) C Beloc Zok (Metoprolol Succinate) C Ismo (Isosorbide Mononitrate) C Ass C 24-Jun-2005 12:19 PM Page: 2379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alna (Tamsulosin Hydrochloride) C Date:07/09/03ISR Number: 4147658-2Report Type:Expedited (15-DaCompany Report #DE_030611535 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Edronax (Reboxetine) C Date:07/09/03ISR Number: 4147659-4Report Type:Expedited (15-DaCompany Report #EWC030635272 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Foreign Zyprexa-Oral Other Neuroleptic Malignant Health (Olanzapine) Syndrome Professional (Olanzapine) PS 5 MG/DAY Pyrexia Other Mirapexin Renal Failure Acute (Pramipexole Rhabdomyolysis Dihydrochloride) C Seropram (Citalopram Hydrobromide) C Halcion (Triazolam) C Date:07/09/03ISR Number: 4147660-0Report Type:Expedited (15-DaCompany Report #EWC030635308 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Hospitalization - Overdose Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS OTHER 1800 MG/OTHER Other Date:07/09/03ISR Number: 4147665-XReport Type:Expedited (15-DaCompany Report #HQWYE801530JUN03 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Health Avlocardyl Life-Threatening Mass Professional (Propranolol Hospitalization - Pancreatitis Acute Other Hydrochloride, Initial or Prolonged Renal Failure Tablet) PS ORAL 1 DF DAILY, ORAL Haldol (Haloperidol) SS ORAL ORAL Paracetamol (Paracetamol) SS ORAL ORAL Veinamitol (Troxerutin) SS Zyprexa (Olanzapine) SS ORAL 5 MG 1 X PER 1 DAY, ORAL 10 DAY Zyrtec (Cetirizine Hydrochloride) SS 24-Jun-2005 12:19 PM Page: 2380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/03ISR Number: 4144486-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041363A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradyarrhythmia Health Quilonum PS Glaxosmithkline ORAL Hypothermia Professional Taxilan SS ORAL Loss Of Consciousness Godamed SS Glaxosmithkline ORAL Clozapine SS ORAL Akineton SS ORAL Pirenzepin SS ORAL Dominal Forte SS ORAL Lorazepam SS ORAL Chlorprothixen SS ORAL Rivotril SS ORAL Orfiril SS ORAL Zyprexa SS ORAL Topamax SS ORAL Seroquel SS ORAL Date:07/10/03ISR Number: 4144631-5Report Type:Direct Company Report #CTU 197618 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Zyprexa Zydis 20mg PS ORAL SEE IMAGE Date:07/10/03ISR Number: 4146699-9Report Type:Expedited (15-DaCompany Report #2002-10-2453 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Other Perphenazine Tablets PS ORAL 2-6 MG QD Initial or Prolonged Alcohol Interaction ORAL Disability Bronchitis Trilafon Other Chest Pain (Perphenazine) Conversion Disorder Tablets SS ORAL 2-6 MG QD Convulsion ORAL Disturbance In Attention Trazodone SS 50 MG HS Drug Interaction Prozac SS 30-10 MG QD Dysphagia Caffeine SS Dysphonia Lithium SS Dystonia Zyprexa (Olanzapine) Eye Movement Disorder Tablets SS ORAL ORAL Headache Vicodin C Mastitis Flexeril C Muscle Spasms Indocin C Musculoskeletal Multivitamins C Discomfort Ativan C Nausea Thyroid C Neck Pain Wellbutrin Neuralgia (Bupropion) C Speech Disorder Zoloft C Tardive Dyskinesia Desipramine C Throat Tightness Effexor C Vomiting Depakote C Weight Decreased Nortriptyline C Doxepin C Dicloxacillin C Clonazepam C Beclomethasone C Ibuprofen C Alprazolam C 24-Jun-2005 12:19 PM Page: 2381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cephalexin C Septran Ds (Trimethoprim/Sulfam ethoxazole) C Date:07/10/03ISR Number: 4147372-3Report Type:Expedited (15-DaCompany Report #FRWYE195330JUN03 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Seresta (Oxazepam, Initial or Prolonged Lymphocyte Count Professional Tablet, 0 ) PS ORAL 50 MG 4X 1 Other Decreased Other DAY, ORAL 51 DAY Pyrexia Athymil (Mianserin White Blood Cell Count Hydrochloride, , 0) SS ORAL 60 MG 1X PER Decreased 1 DAY, ORAL 29 DAY Gabacet (Piracetam, , 0) SS FOR YEARS YR Mediator (Benfluorex Hydrochloride, 0) SS 13 DAY Mepronizine (Aceprometazine/Mepr obamate, 0) SS FOR YEARS YR Nozinan (Levomepromazine, 0) SS ORAL 25 MG 3X PER 1 DAY, ORAL 29 DAY Stilnox (Zolpidem, 0) SS Tegretol (Carbamazepine, 0) SS ORAL 200 MG 1X PER 1 DAY, ORAL 1 YR Tegretol (Carbamazepine, 0) SS 400 MG 1X PER 1 DAY 29 DAY Zoloft (Sertraline Hydrochloride, 0 ) SS ORAL 50 MG 2X PER 1 DAY, ORAL 29 DAY Zyprexa (Olanzapine, 0) SS ORAL 5 MG, 1X PER 1 DAY, ORAL 29 DAY Date:07/10/03ISR Number: 4147373-5Report Type:Expedited (15-DaCompany Report #HQWYE797930JUN03 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congenital Hand Health Effexor (Venlafaxine Malformation Professional Hydrochloride, Maternal Drugs Affecting Other Tablet) PS ORAL 75 MG 1X PER Foetus 1 DAY, ORAL 14 DAY Alprazolam (Alprazolam, ) SS ORAL "PROBALBY" 2 MG DAILY, ORAL Entumin (Clotiapine, ) SS ORAL 40 MG 1X PER 1 TOT, ORAL 1 DAY Nefadar (Nefazodone Hydrochloride,) SS ORAL "200-100 MG" DAILY, ORAL Ponstan (Mefenamic 24-Jun-2005 12:19 PM Page: 2382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid,) SS ORAL "OCCASIONALLY (4-5 TIME/MONTH)", ORAL, YEARS Prazine (Promazine Hydrochloride, Tablet) SS ORAL 50 MG 1X PER 1 TOT, ORAL 1 DAY Primperan (Metoclopramide,) SS ORAL 10 MG, 1X PER 1 DAY, ORAL 23 DAY Seresta (O0xazepam, Tablet) SS ORAL 30 MG 1X PER 1 DAY, ORAL 55 DAY Topamax (Topiramate, ) SS ORAL "200-100 MG" DAILY, ORAL 55 DAY Trittico (Trazodone Hydrochloride,) SS ORAL "50-100 MG" DAILY, ORAL Zyprexa(Olanzapine, ) SS ORAL 2.5 MG 1X PER 1 DAY, ORAL Date:07/11/03ISR Number: 4146201-1Report Type:Direct Company Report #CTU 197731 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Olanzapine 20 Mg Initial or Prolonged Phosphokinase Increased Lilly PS Lilly ORAL 20 MG PO ORAL Divalproex C Date:07/15/03ISR Number: 4149013-8Report Type:Expedited (15-DaCompany Report #US_020988011 Age:63 YR Gender:Male I/FU:F Outcome PT Death Anoxia Hospitalization - Arrhythmia Initial or Prolonged Cardiac Failure Other Congestive Choreoathetosis Coma Confusional State Drug Level Increased Dysarthria Gait Disturbance Grimacing Haemorrhage Subcutaneous Heart Rate Increased Hypotonia Hypoxia Implant Site Haemorrhage Lethargy Myoclonus Nystagmus Overdose Pathogen Resistance Pneumonia Pulmonary Embolism Restlessness 24-Jun-2005 12:19 PM Page: 2383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salivary Hypersecretion Somnolence Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Status Epilepticus Health Zyprexa-Oral Ventricular Tachycardia Professional (Olanzapine) (Olanzapine) PS 750 MG Lithium C Terazosin C Rabeprazole C Methocarbamol C Thiamine C Ibuprofen C Date:07/15/03ISR Number: 4149016-3Report Type:Expedited (15-DaCompany Report #USA030537107 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Consumer Strattera Initial or Prolonged Hallucination, Auditory Health (Atomoxetine Tremor Professional Hydrochloride) PS 25 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS Allegra (Fexofenadine Hydrochloride) C Eskalith (Lithium Carbonate) C Insulin C Microgestin Fe C Pancreas Microtabs C Paxil (Paroxetine Hydrochloride) C Date:07/15/03ISR Number: 4149292-7Report Type:Expedited (15-DaCompany Report #USA030640289 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Multiforme Health Zyprexa-Oral Professional (Olanzapine) PS 2.5 MG/DAY Company Zoloft (Sertraline Representative Hydrochloride) C Date:07/15/03ISR Number: 4149294-0Report Type:Expedited (15-DaCompany Report #USA30640332 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Occlusive Consumer Zyprexa-Oral(Olanzap Disease ine) PS 30 MG/DAY Atherosclerosis Gabapentin C Death Trazodone C Food Craving Insomnia Sinus Arrhythmia Thrombosis Weight Increased 24-Jun-2005 12:19 PM Page: 2384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/03ISR Number: 4149379-9Report Type:Expedited (15-DaCompany Report #EWC030735416 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Urea Increased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Representative Other Date:07/15/03ISR Number: 4149381-7Report Type:Expedited (15-DaCompany Report #US_030795864 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Olanzapine-Oral Initial or Prolonged Drug Interaction Literature (Olanzapine) PS 5 MG/DAY 5 DAY Glucose Urine Health Valproic Acid C Glycosylated Haemoglobin Professional Lithium C Increased Other Haloperidol C Hyperglycaemic Hyperosmolar Nonketotic Syndrome Malaise Polydipsia Polyuria Date:07/15/03ISR Number: 4149383-0Report Type:Expedited (15-DaCompany Report #DE_030611567 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Zyprexa-Oral Initial or Prolonged Thrombosis Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Risperdal(Risperidon e) C Date:07/15/03ISR Number: 4149956-5Report Type:Expedited (15-DaCompany Report #JP_030501007 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Zyprexa-Oral Initial or Prolonged Eating Disorder Study (Olanzapine) Facial Palsy Health (Olanzapine) PS 10 MG/DAY Hemiplegia Professional Tolopelon Other (Timiperone) C Biofermin C Trihexyphenidyl Hydrochloride C Towarat (Nifedipine) C Renivace (Enalapril Maleate) C Alfacalcidol C Vegetamin A C Silece (Flunitrazepam) C Contomin (Chlorpromazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Adalat (Nifedipine) C Date:07/15/03ISR Number: 4149957-7Report Type:Expedited (15-DaCompany Report #JP_030500928 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acoustic Neuroma Foreign Zyprexa-Oral Initial or Prolonged Cerebellar Tumour Study (Olanzapine) Dizziness Health (Olanzapine) PS 5 MG/DAY Gait Disturbance Professional Emilace Other (Nemonapride) C Artane (Trihexyphenidyl Hydrochloride) C Tegretol (Carbamazepine) C Gascon (Dimeticone) C Politose C Benzalin (Nitrazepam) C Alosenn C Date:07/15/03ISR Number: 4149963-2Report Type:Expedited (15-DaCompany Report #EWC030434730 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Foreign Zyprexa-Oral Gastrointestinal Disorder Health (Olanzapine) Mania Professional (Olanzapine) PS 15 MG/DAY 6 MON Thrombosis Company Representative Other Date:07/15/03ISR Number: 4150166-6Report Type:Expedited (15-DaCompany Report #03P-153-0223589-00 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemic Foreign Valproic Acid Initial or Prolonged Hyperosmolar Nonketotic Literature (Depakene) (Valproic Syndrome Health Acid) (Valproic Malaise Professional Acid) PS 1000 MG, 1 IN Polydipsia 1 D Polyuria Lithium SS 600 MG, 1 IN 1 D Olanzapine SS 5 MG, 1 IN 1 D Haloperidol C Date:07/15/03ISR Number: 4150288-XReport Type:Expedited (15-DaCompany Report #EWC030735435 Age:40 YR Gender:Female I/FU:I Outcome PT Other Abdominal Discomfort Anorexia Asthenia Asthma Condition Aggravated 24-Jun-2005 12:19 PM Page: 2386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eye Pain Fatigue Mental Impairment Report Source Product Role Manufacturer Route Dose Duration Mood Altered Foreign Zyprexa-Oral Nausea Health (Olanzapine) Oedema Peripheral Professional (Olanzapine) PS 10 MG/DAY Pruritus Other Paroxetine C Psychomotor Retardation Buspirone C Psychotic Disorder Benztropine C Weight Decreased Date:07/15/03ISR Number: 4150293-3Report Type:Expedited (15-DaCompany Report #EWC030735389 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Congenital Hand Foreign Olanzapine-Oral Congenital Anomaly Malformation Health (Olanzapine) PS Maternal Drugs Affecting Professional Xanax (Alprazolam) C Foetus Other Topamax (Topiramate) C Nefadar (Nefazodone Hydrochloride) C Trittico (Trazodone Hydrochloride) C Seresta (Oxazepam) C Primperan (Metoclopramide) C Efexor (Venlafaxine Hydrochloride) C Clotiapine C Mefenamic Acid C Prazine (Promazine Hydrochloride) C Date:07/15/03ISR Number: 4150295-7Report Type:Expedited (15-DaCompany Report #FR_030702637 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Chronic Foreign Zyprexa-Oral Initial or Prolonged Bronchitis Pneumococcal Health (Olanzapine) Depressed Level Of Professional (Olanzapine) PS 1 DSG Consciousness Other FORM/DAY Inappropriate Depakine (Valproate Antidiuretic Hormone Sodium) C Secretion Date:07/15/03ISR Number: 4150298-2Report Type:Expedited (15-DaCompany Report #GBS030713339 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 2387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/03ISR Number: 4148345-7Report Type:Expedited (15-DaCompany Report #WAES 0307DEU00072 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Vioxx PS Merck & Co., Inc ORAL Life-Threatening Dialysis Enalapril Maleate SS ORAL Hospitalization - Drug Interaction Risperidone SS ORAL Initial or Prolonged Duodenal Ulcer Olanzapine SS ORAL Haemorrhage Esomeprazole Renal Failure Magnesium SS ORAL Furosemide Sodium SS ORAL Date:07/16/03ISR Number: 4148596-1Report Type:Direct Company Report #CTU 198055 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Increased Olanzapine PS ORAL 7.5 2 HS PO 6 WK Initial or Prolonged Other Date:07/16/03ISR Number: 4148607-3Report Type:Direct Company Report #CTU 198065 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Olanzapine 5 Mg Initial or Prolonged Difficulty In Walking Tablet PS 5 MG QHS Hallucination Lorazepam 1 Mg Hyperhidrosis Tablet SS 1 MG BID PRN Mental Status Changes Muscle Rigidity Date:07/16/03ISR Number: 4150064-8Report Type:Expedited (15-DaCompany Report #EWC030735362 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Zyprexa-Oral Initial or Prolonged Drug Ineffective Health (Olanzapine)(Olanzap Pancreatic Necrosis Professional ine) PS 3.8 MG/DAY Sepsis Other Tremor Urinary Retention Weight Increased Date:07/16/03ISR Number: 4150217-9Report Type:Expedited (15-DaCompany Report #CA_030606052 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Increased Foreign Olanzapine-Oral Hospitalization - Diabetic Ketoacidosis Study (Olanzapine) PS 10 MG/AT Initial or Prolonged Health BEDTIME Professional Sertraline C Other 24-Jun-2005 12:19 PM Page: 2388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/03ISR Number: 4150719-5Report Type:Direct Company Report #CTU 198163 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Olanzapine PS ORAL 20 MG PO QD Drug Level Increased Lithium Carbonate C Drug Toxicity Cogentin C Hypertension Prevacid C Thiamine C Prolixin Decanoate C Date:07/17/03ISR Number: 4151215-1Report Type:Expedited (15-DaCompany Report #03P-062-0223625-00 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Foreign Akineton(Biperiden) Initial or Prolonged Hypothermia Health (Biperiden) PS ORAL PER ORAL Loss Of Consciousness Professional Perazine SS ORAL PER ORAL Poisoning Godamed SS ORAL PER ORAL Clozapine SS ORAL PER ORAL Pirenzepine SS ORAL PER ORAL Prothipendyl Hydrochloride SS ORAL PER ORAL Lorazepam SS ORAL PER ORAL Chlorprothixene SS ORAL PER ORAL Clonazepam SS ORAL PER ORAL Orfiril SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Topiramate SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Lithium Carbonate SS ORAL PER ORAL Date:07/21/03ISR Number: 4150384-7Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0417270A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Bupropion PS Glaxosmithkline ORAL Completed Suicide Ethanol SS Fall Zyprexa SS Intentional Misuse Nortriptyline SS Xanax SS Acetaminophen SS Glaxosmithkline Nexium C Nicorette C Glaxosmithkline Date:07/21/03ISR Number: 4151163-7Report Type:Direct Company Report #CTU 198289 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Olanzapine PS ORAL 10MG QHS ORAL Initial or Prolonged Date:07/21/03ISR Number: 4152805-2Report Type:Expedited (15-DaCompany Report #03-0056 Age:22 YR Gender:Female I/FU:I Outcome PT Congenital Anomaly Complications Of Maternal Exposure To Therapeutic 24-Jun-2005 12:19 PM Page: 2389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drugs Pregnancy Report Source Product Role Manufacturer Route Dose Duration Other Ponstel (Mefenamic Acid 250 Mg Capsules) Nda 15-034 PS ORAL 4-5 TIMES/MONTH, PO Seresta Expidet (Oxazepam) SS ORAL 30MG, PO Alprazolam SS ORAL PO Zyprexa (Olanzapine) SS ORAL 2.5 MG, DAILY, PO Nefadar (Nefazodone) SS ORAL 200MG, PO Topamax (Topiramate) SS ORAL 200MG , PO Efexor (Venlafaxine) SS ORAL 75MG, DAILY, PO Prazine (Promazine) SS ORAL 50MG, DAILY, PO Primperan (Metoclopramide) C Entumine (Clotiapine): C Trittico (Trazodone) C Date:07/21/03ISR Number: 4152923-9Report Type:Expedited (15-DaCompany Report #03-0057 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Congenital Hand Other Ponstel(Mefenamic Congenital Anomaly Malformation Acid 250 Mg Maternal Drugs Affecting Capsules) Nda 15-034 PS ORAL 4-5 Foetus TIMES/MONTH, Pregnancy PO Seresta Expidet (Oxazepam) SS ORAL 30MG, PO Alprazolam SS ORAL PO Zyprexa (Olanzapine) SS ORAL 2.5MG, DAILY, PO Nefadar (Nefazodone) SS ORAL 200MG, PO Topamax (Topiramate) SS ORAL 200MG, PO Efexor (Venlafaxine) SS ORAL 75MG, DAILY, PO Prazine (Promazine) SS ORAL 50MG, DAILY, PO Primperan (Metoclopramide) C Entumine C Tritico (Trazodone) C Date:07/23/03ISR Number: 4155223-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030601299 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Haldol (Haloperidol) Life-Threatening Neoplasm Of Appendix Health Unspecified PS ORAL ORAL Hospitalization - Pancreatitis Acute Professional Avlocardyl Initial or Prolonged Renal Failure (Propranolol) SS ORAL 40 MG, ORAL Paracetamol 24-Jun-2005 12:19 PM Page: 2390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paracetamol) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL 5 MG, 1 IN 1 DAY, ORAL Zyrtec (Cetirizine Hydrochloride) SS ORAL 10 MG, ORAL Veinamitol (Troxerutin) SS ORAL 1000 MG, 1 IN 1 DAY, ORAL Date:07/24/03ISR Number: 4156101-9Report Type:Expedited (15-DaCompany Report #2003020437 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Zoloft (Sertraline) PS Disease Recurrence Professional Rofecoxib Drug Interaction Company (Rofecoxib) SS Grand Mal Convulsion Representative Olanzapine (Olanzapine) SS Date:07/24/03ISR Number: 4156139-1Report Type:Expedited (15-DaCompany Report #EWC030735509 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Zyprexa-Oral Initial or Prolonged Diabetic Complication Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS 10 MG/DAY Visual Disturbance Company Representative Other Date:07/24/03ISR Number: 4156148-2Report Type:Expedited (15-DaCompany Report #DE_030711645 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pemphigus Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 IN Other THE EVENING 6 YR Date:07/24/03ISR Number: 4156149-4Report Type:Expedited (15-DaCompany Report #DE_030711637 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Foreign Zyprexa-Oral Initial or Prolonged Inversion Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Solian (Amisulpride) C Ferro Sanol C Date:07/24/03ISR Number: 4156151-2Report Type:Expedited (15-DaCompany Report #JP_030701336 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Disability Akinesia Foreign Mutism Study Health Professional 24-Jun-2005 12:19 PM Page: 2391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/1 DAY Haloperidol C Bromperidol C Cremin (Mosapramine Hydrochloride) C Levotomin (Levomepromazine Maleate) C Biperiden C Benzalin (Nitrazepam) C Gasmotin (Mosapride Citrate) C Sennoside A C Date:07/24/03ISR Number: 4156255-4Report Type:Expedited (15-DaCompany Report #FR_030702671 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Foreign Zyprexa-Oral Initial or Prolonged Caesarean Section Health (Olanzapine) Complications Of Maternal Professional (Olanzapine) PS Exposure To Therapeutic Other Drugs Foetal Growth Retardation Hypertonia Neonatal Jaundice Neonatal Labour Onset Delayed Maternal Drugs Affecting Foetus Ophthalmia Neonatorum Pregnancy Induced Hypertension Proteinuria Tremor Neonatal Date:07/24/03ISR Number: 4156259-1Report Type:Expedited (15-DaCompany Report #FR_030702667 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Rivotril (Clionazepam) C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/03ISR Number: 4156266-9Report Type:Expedited (15-DaCompany Report #GBS030713359 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Fibrillation Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:07/24/03ISR Number: 4156270-0Report Type:Expedited (15-DaCompany Report #FR_030702648 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Zyprexa-Oral Initial or Prolonged Febrile Neutropenia Health (Olanzapine) White Blood Cell Count Professional (Olanzapine) PS 5 MG/DAY Decreased Other Mepronizine C Gabacet (Piracetam) C Tegretol ( Carbamazepine ) C Nozinan (Levomepromazine) C Seresta (Oxazepam) C Stilnox (Zolpidem) C Mediator (Benfluorex Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Athymil (Mianserin Hydrochloride) C Aparanax (Naproxen Sodium) C Lanzor (Lansoprazole) C Date:07/24/03ISR Number: 4156272-4Report Type:Expedited (15-DaCompany Report #FR_030602593 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Echography Abnormal Foreign Zyprexa - Oral Life-Threatening Leukocytosis Health (Olanzapine) Hospitalization - Neoplasm Of Appendix Professional (Olanzapine) PS 5 MG/DAY Initial or Prolonged Pancreatitis Acute Other Avlocardyl Renal Failure Acute (Propranolol) C Vomiting Paracetamol C Zyrtec (Ceterizine Hydrochloride) C Veinamitol (Troxerutin) C Date:07/24/03ISR Number: 4156276-1Report Type:Expedited (15-DaCompany Report #FR_030602504 Age:53 YR Gender:Male I/FU:I Outcome PT Hospitalization - Bradycardia Initial or Prolonged Dizziness Sinus Arrest 24-Jun-2005 12:19 PM Page: 2393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa - Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Stilnox C Date:07/24/03ISR Number: 4156325-0Report Type:Expedited (15-DaCompany Report #USA021225267 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Consumer Zyprexa-Oral Delusion (Olanzapine) PS ORAL 5 MG/DAY Diarrhoea Stomatitis Date:07/24/03ISR Number: 4156354-7Report Type:Expedited (15-DaCompany Report #DSA_22996_2003 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dialysis Foreign Enalapril Maleate PS ORAL 5 MG QD PO Life-Threatening Drug Interaction Health Rofecoxib SS ORAL 25 MG UNK PO Hospitalization - Duodenal Ulcer Professional Risperdal SS ORAL 1.5 MG QD PO Initial or Prolonged Haemorrhage Other Zyprexa SS ORAL 10 MG QD PO Renal Failure Nexium SS 20 MG BID Lasix SS ORAL 40 MG QD PO Date:07/24/03ISR Number: 4156451-6Report Type:Expedited (15-DaCompany Report #JP_030701335 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyperxa-Oral Stress Health (Olanzapine) Professional (Olanzapine) PS Company Risperdal Representative (Risperidone) C Date:07/24/03ISR Number: 4156453-XReport Type:Expedited (15-DaCompany Report #GBS030713394 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Exfoliative Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG/1 DAY Professional Carbamazepine C Other Lithium C Date:07/24/03ISR Number: 4156456-5Report Type:Expedited (15-DaCompany Report #GBS030713329 Age:50 YR Gender:Female I/FU:I Outcome PT Disability Asthenia Coordination Abnormal Dysarthria Dysphagia Dysphasia 24-Jun-2005 12:19 PM Page: 2394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 15 MG Professional Enalapril C Other Bendrofluazide C Date:07/24/03ISR Number: 4156459-0Report Type:Expedited (15-DaCompany Report #FR_030702684 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cytolytic Hepatitis Foreign Zyprexa-Dispersible Initial or Prolonged Delirium Health (Olanzapine) Hypertension Professional (Olanzapine) PS 20 MG/DAY Weight Increased Company Seropram (Citalopram Representative Hydrobromide) C Other Temesta (Lorazepam) C Lepticur (Tropatepine Hydrochloride) C Date:07/24/03ISR Number: 4156496-6Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20030702042 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Topamax (Topiramate) Congenital Anomaly Health Tablets PS 200MG-100MG Professional Seresta (Oxazepam) Tablets SS INTRA-UTERINE 30 MG, 1 IN 1 DAY, INTRA-UTERINE Zyprexa (Olanzapine) Tablets SS INTRA-UTERINE 2.5 MG, 1 IN 1 DAY, INTRA-UTERINE Nefadar (Nefazodone Hydrochloride) Tablets SS 100-100MG/DAI LY Efexor (Venlafaxine Hydrochloride) Capsule SS INTRA-UTERINE 75 MG, 1 IN 1 DAY, INTRA-UTERINE Mefenamic Acid (Mefenamic Acid) Tablets SS INTRA-UTERINE 500 MG, 4 IN 1 MONTH, INTRA-UTERINE Trittico (Trazodone Hydrochloride) Tablets SS 150-100MG/DAI LY Entumine (All Other Therapeutic Products) Tablets SS INTRA-UTERINE 40 MG, 1 IN 1 DAY, INTRA-UTERINE 24-Jun-2005 12:19 PM Page: 2395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Primperan (Metoclopramide) Tablets SS INTRA-UTERINE 10 MG, 1 IN 1 , INTRA-URINE Prazine (Promazine Hydrochloride) Tablets SS INTRA-UTERINE 50 MG, 1 IN 1 DAY, INTRA-UTERINE Date:07/24/03ISR Number: 4156632-1Report Type:Expedited (15-DaCompany Report #EWC030534902 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine)(Olanzap Professional ine) PS 5 MG/DAY Other Dipyridamole C Movicol C Date:07/24/03ISR Number: 4156634-5Report Type:Expedited (15-DaCompany Report #US_021189448 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Olanzapine-Oral Initial or Prolonged Gastric Mucosal Lesion Study (Olanzapine) PS 20 MG DAY Haematemesis Health Wintermin Hepatic Cirrhosis Professional (Chlorpromazine Hypoglycaemia Other Hydrochloride) C Hypoproteinaemia Linton (Haloperidol) C Prurigo Tasmolin (Biperiden) C White Blood Cell Count Pantosin Increased (Pantethine) C Hirnamin (Levomepromazine) C Lendormin (Brotizolam) C Halcion (Triazolam) C Magnesium Oxide C Pursennid (Senna Leaf) C Sodium Picosulfate C Lexin (Carbamazepine) C Dogmatyl (Sulpiride) C Date:07/24/03ISR Number: 4156705-3Report Type:Expedited (15-DaCompany Report #JP_030100328 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Zyprexa-Oral Antisocial Behaviour Study (Olanzapine) Dementia Health (Olanzapine) PS 10 MG/DAY Disorientation Professional Orap (Pimozide) C Dysphagia Company Artane Eye Rolling Representative (Trihexyphenidyl Insomnia Other Hydrochloride) C Lexotan (Bromazepam) C 24-Jun-2005 12:19 PM Page: 2396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metligine (Midodrine Hydrochloride) C Cabagin-U Tab. (Vitamin U) C Date:07/24/03ISR Number: 4156707-7Report Type:Expedited (15-DaCompany Report #JP_030500944 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest X-Ray Abnormal Foreign Zyprexa-Oral Initial or Prolonged Eosinophil Count Company (Olanzapine) Increased Representative (Olanzapine) PS 10 MG/DAY Fall Other Risperdal Femoral Neck Fracture (Risperidone) C Pleural Effusion Flunitrazepam C Pneumonia Chinese Medicine C White Blood Cell Count Increased Date:07/24/03ISR Number: 4156709-0Report Type:Expedited (15-DaCompany Report #GBS030613281 Age:50 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aphasia Foreign Olanzapine-Oral Asthenia Health (Olanzapine) PS 15 MG/UNKNOWN Dysphasia Professional Bendrofluazide C Other Enalapril C Date:07/24/03ISR Number: 4156711-9Report Type:Expedited (15-DaCompany Report #GBS030513089 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Other Date:07/24/03ISR Number: 4156713-2Report Type:Expedited (15-DaCompany Report #EWC030635138 Age:64 YR Gender:Male I/FU:F Outcome PT Death Aortic Atherosclerosis Life-Threatening Blood Creatine Hospitalization - Phosphokinase Mb Initial or Prolonged Blood Creatinine Increased Blood Ph Decreased Cerebral Atrophy Chest X-Ray Abnormal Culture Urine Positive Drug Interaction Dysarthria Encephalopathy Enterobacter Infection Hyperpyrexia Periventricular Leukomalacia 24-Jun-2005 12:19 PM Page: 2397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pseudomonas Infection Sopor White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Carbolithium (Lithium Carbonate) C Clopixol (Zuclopenthixol Decanoate) C Novonorm (Repaglinide) C Rivotril (Clonazepam) C Bb-K8 (Amikacin Sulfate) C Trental (Pentoxifylline) C Ciproxin (Ciprofloxacin) C Targosid (Teicoplanin) C Diflucan (Fluconazole) C Date:07/24/03ISR Number: 4156715-6Report Type:Expedited (15-DaCompany Report #EWC030635151 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG/DAY Professional Zopiclone C Company Grn C Representative Flupentixol Other Decanoate C Amoxycillin C Vitamin B Complex C Ventolin (Salbutamol) C Losec (Omeprazole) C Clonazepam C Diastop C Panadeine C Date:07/24/03ISR Number: 4156728-4Report Type:Expedited (15-DaCompany Report #FR_020701174 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS 10 MG/DAY Drugs Other Parlodel Delirium (Bromocriptine Hypertension Mesilate) C Phlebitis Proteinuria 24-Jun-2005 12:19 PM Page: 2398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/03ISR Number: 4156730-2Report Type:Expedited (15-DaCompany Report #EWC030735521 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Olanzapine-Dispersib Initial or Prolonged Malnutrition Health le (Olanzapine) PS 20 MG/DAY Pancytopenia Professional Valium (Diazepam) C Other Date:07/25/03ISR Number: 4153886-2Report Type:Direct Company Report #CTU 198653 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Lexapro 10 Mg Hospitalization - Delayed Recovery From Forrest PS Forrest ORAL 10 MG QDAY Initial or Prolonged Anaesthesia ORAL Required Hyperhidrosis Zyprexa 2.5 Mg And Intervention to Muscle Rigidity 20 Mg Eli Lilly SS Eli Lilly ORAL 2.5 MG, 20 Prevent Permanent Nervous System Disorder QAM, QHS ORAL Impairment/Damage Rhabdomyolysis Phenergan C Tremor Toprol Xl C Aspirin C Nitroglycerin Sl C Prilosec C Pepcid C Lasix C Potassium C Flomax C Reglan C Zoloft C Remeron C Date:07/25/03ISR Number: 4156896-4Report Type:Expedited (15-DaCompany Report #US_030796240 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Disorder Foreign Olanzapine-Oral Initial or Prolonged Metrorrhagia Health (Olanzapine) PS 10 MG/DAY Other Pancytopenia Professional Levomepromazine C Other Trifluoperazine C Date:07/28/03ISR Number: 4155365-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-342737 Age:69 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Anaemia Blood Creatine Phosphokinase Increased Cardiac Murmur Confusional State Drug Interaction Encephalopathy Febrile Convulsion Liver Function Test Abnormal Lung Infection Miosis Nausea 24-Jun-2005 12:19 PM Page: 2399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Rales Renal Impairment Report Source Product Role Manufacturer Route Dose Duration Tachycardia Rivotril PS Roche ORAL Zofran C ORAL Co-Reniten C ORAL Primperan C ORAL Prepulsid C ORAL Antra C ORAL Microklist C ORAL Movicol C ORAL Aspirin Cardio C ORAL Halcion I ORAL Mst Continus I ORAL Zyprexa I ORAL Date:07/28/03ISR Number: 4155806-3Report Type:Direct Company Report #USP 50272 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa 10mg PS Lilly Zyrtec 10mg SS Pfizer Date:07/28/03ISR Number: 4156048-8Report Type:Direct Company Report #USP 50672 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Ziac PS Lederle Zyprexa SS Lilly Date:07/28/03ISR Number: 4156224-4Report Type:Direct Company Report #USP 50298 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Pfizer TABLET Zyprexa SS Lilly TABLET Date:07/28/03ISR Number: 4156264-5Report Type:Direct Company Report #USP 50538 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly TABLET Zyrtec SS Pfizer TABLET Date:07/28/03ISR Number: 4156288-8Report Type:Direct Company Report #USP 50547 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly 24-Jun-2005 12:19 PM Page: 2400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/03ISR Number: 4158288-0Report Type:Expedited (15-DaCompany Report #2003028963 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Foreign Lipitor Initial or Prolonged Alanine Aminotransferase Health (Atorvastatin) PS ORAL 10 MG Aspartate Professional (DAILY), ORAL Aminotransferase Olanzapine Blood Bilirubin (Olanzapine) SS ORAL 10 MG Blood Lactate (DAILY), ORAL Dehydrogenase Allopurinol C-Reactive Protein (Allopurinol) SS ORAL 100 MG Drug Hypersensitivity (DAILY), ORAL Gamma-Glutamyltransferase Risperidone Haemoglobin (Risperidone) SS ORAL 4 MG (DAILY), Hepatic Function Abnormal ORAL Infection Vegetamin A Platelet Count (Phenobarbital, Pyrexia Promethazine, Rash Chlorpromazine White Blood Cell Count Hydrochloride) SS ORAL 1 DF (DAILY), ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) SS ORAL 2 MG (DAILY), ORAL Cloxazolam (Cloxazolam) C Date:07/29/03ISR Number: 4156571-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342779 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Rivotril PS Roche ORAL Initial or Prolonged Zyprexa SS ORAL IN THE EVENING. Zyprexa SS ORAL IN THE EVENING. Depakote SS ORAL Date:07/29/03ISR Number: 4156942-8Report Type:Direct Company Report #USP 55970 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Pfizer Labs Zyprexa 10mg SS Lilly Date:07/29/03ISR Number: 4157511-6Report Type:Direct Company Report #CTU 198892 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Zyprexa PS 24-Jun-2005 12:19 PM Page: 2401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/03ISR Number: 4158556-2Report Type:Expedited (15-DaCompany Report #US_030494123 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Consumer Zyprexa-Oral Other Cardiac Arrest (Olaznapine) PS Coma Diabetes Mellitus Date:07/29/03ISR Number: 4159266-8Report Type:Expedited (15-DaCompany Report #JP_030701385 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa Initial or Prolonged Hypertension Study (Olanzapine) PS ORAL 10 MG/DAY Osteoarthritis Health Linton (Haloperidol) C Weight Increased Professional Tasmolin (Biperiden) C Other Gasmotin (Mosapride Citrate) C Kolantyl C Gaster (Famotidine) C Thyradin S (Levothyroxine Sodium) C Infree (Indometacin) C Silece (Flunitrazepan) C Date:07/29/03ISR Number: 4159278-4Report Type:Expedited (15-DaCompany Report #FR_030702695 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Foreign Zyprexa-Oral Initial or Prolonged Fall Health (Olanzapine) Loss Of Consciousness Professional (Olanzapine) PS Nervous System Disorder Other Tercian Rhabdomyolysis (Cyamemazine) C Date:07/29/03ISR Number: 4159279-6Report Type:Expedited (15-DaCompany Report #EWC030735641 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG/DAY Other Altiazem (Diltiazem Hydrochloride) C Cardiovasc(Lercanidi pine Hydrochloride) C Mepral (Omeprazole) C Rivotril (Clonazepam) C Candesartan C 24-Jun-2005 12:19 PM Page: 2402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/03ISR Number: 4159280-2Report Type:Expedited (15-DaCompany Report #EWC030735635 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa-Dispersible Initial or Prolonged Coma Health (Olanzapine) Depressed Level Of Professional (Olanzapine) PS 1960 MG/DAY Consciousness Company Seroquel (Quetiapine Lipase Increased Representative Fumarate) C Overdose Other Tavor (Lorazepam) C Suicide Attempt Tachycardia Ventricular Extrasystoles Date:07/29/03ISR Number: 4159281-4Report Type:Expedited (15-DaCompany Report #EWC030735604 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Blood Creatine Company (Olanzapine) Phosphokinase Increased Representative (Olanzapine) PS 10 MG/DAY Headache Other Neurontin Hepatic Enzyme Increased (Gabapentin) C Hyperkalaemia Musculoskeletal Pain Pyrexia Renal Failure Vomiting Date:07/29/03ISR Number: 4159282-6Report Type:Expedited (15-DaCompany Report #EWC030735575 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:07/29/03ISR Number: 4159283-8Report Type:Expedited (15-DaCompany Report #DE_030711663 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Prescribed Overdose Foreign Zyprexa-Oral Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 30 MG/DAY Other Sortis (Atorvastatin Calcium) C Pipamperone C Metex (Methotrexate Sodium) C Date:07/29/03ISR Number: 4159285-1Report Type:Expedited (15-DaCompany Report #JP_030500883 Age:69 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Aspartate Aminotransferase 24-Jun-2005 12:19 PM Page: 2403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Bilirubin Blood Lactate Dehydrogenase Report Source Product Role Manufacturer Route Dose Duration Cholecystitis Foreign Olanzapine-Oral Difficulty In Walking Study (Olanzapine) PS 10 MG/2 DAY Hepatic Function Abnormal Health Miradol (Sulpiride) C Ileus Professional Biperiden C Oral Intake Reduced Other Serenace (Haloperidol) C Parkin (Profenamine) C Halcion (Triazolam) C Pursennide (Senna Leaf) C Adalat L (Nifedipine) C Gaster (Famotidine) C Date:07/29/03ISR Number: 4159577-6Report Type:Expedited (15-DaCompany Report #FR_020100595 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Diabetes Mellitus Literature (Olanzapine) Hypertriglyceridaemia Health (Olanzapine) PS 15 MG/DAY Ketoacidosis Professional Ketonuria Company Oral Candidiasis Representative Proteinuria Other Weight Increased Date:07/29/03ISR Number: 4159578-8Report Type:Expedited (15-DaCompany Report #JP_030601172 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Affect Lability Foreign Zyprexa-Oral Life-Threatening Blood Creatine Study (Olanzapine0 Phosphokinase Increased Health (Olanzapine) PS 2.5 MG/DAY Completed Suicide Professional Condition Aggravated Other Constipation Delusion Hallucination Mental Disorder Pigmentation Disorder Rash Papular Somnolence Date:07/29/03ISR Number: 4159579-XReport Type:Expedited (15-DaCompany Report #JP_030601146 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Study (Olanzapine) Difficulty In Walking Health (Olanzapine) PS 5 MG/DAY Gait Disturbance Professional Serenace Large Intestine Carcinoma Other (Haloperidol) C Contomin (Chlorpromazine 24-Jun-2005 12:19 PM Page: 2404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Bezalip (Bezafibrate) C Norvasc (Amlodipine Besilate) C Eurodin (Estazolam) C Date:07/29/03ISR Number: 4159580-6Report Type:Expedited (15-DaCompany Report #EWC030534861 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Viral Foreign Zyprexa-Oral Hospitalization - Shock Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG 6 MON Company Representative Other Date:07/29/03ISR Number: 4159581-8Report Type:Expedited (15-DaCompany Report #EWC030635308 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zypexa-Oral Hospitalization - Intentional Misuse Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 1800 MG/OTHER Other Date:07/29/03ISR Number: 4159582-XReport Type:Expedited (15-DaCompany Report #JP_030601208 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Autonomic Neuropathy Foreign Zyprexa-Oral Chorea Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS 2.5 MG/DAY Dystonia Company Permax (Pergolide Extrapyramidal Disorder Representative Mesylate) SS 750 UG/DAY Hypokalaemia Other Symmetrel On And Off Phenomenon (Amantadine Psychiatric Symptom Hydrochloride) C Pyrexia Levodopa Benserazide Respiratory Arrest Hydrochloride C Respiratory Failure Depromel Soliloquy (Fluvoxamine) C Suicidal Ideation Thyradin S Temperature Regulation (Levothyroxine Disorder Sodium) C Vocal Cord Disorder Pantosin (Panthetine) C Magnesium Oxide C 24-Jun-2005 12:19 PM Page: 2405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/03ISR Number: 4159584-3Report Type:Expedited (15-DaCompany Report #JP_030701391 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Foreign Zyprexa-Oral Hallucination, Visual Literature (Olanzapine) Hypothermia Health (Olanzapine) PS 2.5 MG/AT Professional BEDTIME Other Date:07/29/03ISR Number: 4159588-0Report Type:Expedited (15-DaCompany Report #03P-056-0225134-00 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Depakote Tablets Initial or Prolonged Health (Depakote) Professional (Divalproex Sodium) (Divalproex Sodium) PS ORAL 1 DOSAGE FORMS, 3 IN 1 D, ORAL Clonazepam SS ORAL 1 MG, 2 IN 1 D, ORAL Olanzapine SS ORAL SEE IMAGE Meprobamate C Date:07/29/03ISR Number: 4159621-6Report Type:Expedited (15-DaCompany Report #US_030796229 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Date:07/29/03ISR Number: 4159622-8Report Type:Expedited (15-DaCompany Report #US_030796210 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olazapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Lithium C Date:07/29/03ISR Number: 4159623-XReport Type:Expedited (15-DaCompany Report #US_030796233 Age:23 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine -Oral Intentional Misuse Health (Olanzapine) PS Professional Fluoxetine-Oral (Fluoxetine) (Fluoxetine Hydrochlor SS Trazodone C 24-Jun-2005 12:19 PM Page: 2406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/03ISR Number: 4159624-1Report Type:Expedited (15-DaCompany Report #US_030796176 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Fluoxetine-Oral(Flox etine) (Fluoxetine Hydrochloride) SS Bupropion C Date:07/29/03ISR Number: 4159625-3Report Type:Expedited (15-DaCompany Report #USA030741194 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Consumer Zyprexa-Oral Other Coma (Olanzapine) PS 2.5 MG Sedation Cardura (Doxazosin Sepsis Mesilate) C Aricept (Donepezil Hydrochloride) C Date:07/29/03ISR Number: 4159626-5Report Type:Expedited (15-DaCompany Report #USA030741515 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Health Zyprexa-Oral Initial or Prolonged Blood Glucose Increased Professional (Olanzapine) PS 30 MG Other Cataract Company Geodon (Ziprasidone Representative Hydrochloride) C Mellaril (Thioridazine Hydrochloride) C Gabitril (Tiababine Hydrochloride) C Tegretol (Carbamazepine) C Risperdal (Risperidone) C Date:07/29/03ISR Number: 4159658-7Report Type:Expedited (15-DaCompany Report #03P-062-0223625-00 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Foreign Akineton (Biperiden) Initial or Prolonged Hypothermia Health (Biperiden) PS ORAL PER ORAL Loss Of Consciousness Professional Perazine SS ORAL PER ORAL Poisoning Godamed SS ORAL PER ORAL Clozapine SS ORAL PER ORAL Pirenzepine SS ORAL PER ORAL Prothipendyl Hydrochloride SS ORAL PER ORAL Lorazepam SS ORAL PER ORAL Chlorprothixene SS ORAL PER ORAL Clonazepam SS ORAL PER ORAL Orfiril SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Topiramate SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL 24-Jun-2005 12:19 PM Page: 2407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate SS ORAL PER ORAL Date:07/30/03ISR Number: 4160281-9Report Type:Expedited (15-DaCompany Report #2003-DE-02977GD (0) Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acetonaemia Foreign Lithium Carbonate Initial or Prolonged Blood Glucose Increased Literature (Lithium Carbonate) PS 600 MG Blood Osmolarity Olanzapine Increased (Antipsychotics) SS 5 MG Diabetic Hyperosmolar Valproic Acid Coma (Valproic Acid) SS 1000 MG Glucose Urine Present Glycosylated Haemoglobin Increased Malaise Polydipsia Polyuria Date:07/30/03ISR Number: 4160886-5Report Type:Expedited (15-DaCompany Report #2003169566CH Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adhesion Foreign Halcion(Triazolam)Ta Initial or Prolonged Agitation Health blet PS ORAL 0.25 MG, QD, Anaemia Professional ORAL Bladder Cancer Other Zyprexa(Olanzapine) SS ORAL 5 MG, QD, Blood Creatine ORAL Phosphokinase Increased Mst Continus Catheter Related (Morphine Sulfate) SS 90 MG DAILY Complication Rivotril(Clonazepam) SS 1 GM, QD Cerebral Atrophy Zofran (Ondansetron Confusional State Hydrochloride) C Constipation Primperan C Device Failure Co-Reniten C Disorientation Prepulsid Diverticulum (Cisapride) C Drug Ineffective Aspirine C Encephalopathy Antra C Gastric Ulcer Movicol C Helicobacter Gastritis Microklist C Hydronephrosis Hyperhidrosis Hypertension Inguinal Hernia Intestinal Hypomotility Metastases To Liver Metastases To Lung Nausea Osteoarthritis Physical Examination Abnormal Pyrexia Renal Cyst Renal Impairment Tachycardia 24-Jun-2005 12:19 PM Page: 2408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/03ISR Number: 4161310-9Report Type:Expedited (15-DaCompany Report #US_030796166 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Valproic Acid C Date:07/30/03ISR Number: 4161314-6Report Type:Expedited (15-DaCompany Report #US_030796164 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Literature Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Hydrocodone C Date:07/30/03ISR Number: 4161336-5Report Type:Expedited (15-DaCompany Report #US_030796169 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Valproic Acid C Date:07/30/03ISR Number: 4161337-7Report Type:Expedited (15-DaCompany Report #US_030796171 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Amitriptyline C Verapamil C Date:07/30/03ISR Number: 4161338-9Report Type:Expedited (15-DaCompany Report #US_030796179 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Bupropion C Gabapentin C Date:07/30/03ISR Number: 4161339-0Report Type:Expedited (15-DaCompany Report #US_030796209 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Lithium C Hydrocodone W/Acetaminophen C 24-Jun-2005 12:19 PM Page: 2409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/03ISR Number: 4161341-9Report Type:Expedited (15-DaCompany Report #US_030796172 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Bupropion C Fluvoxamine C Date:07/30/03ISR Number: 4161343-2Report Type:Expedited (15-DaCompany Report #US_030796173 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Bupropion C Date:07/31/03ISR Number: 4158688-9Report Type:Direct Company Report #CTU 198970 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Olanzapine PS Initial or Prolonged Phosphokinase Increased Date:08/01/03ISR Number: 4159327-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342779 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Rivotril PS Roche ORAL Initial or Prolonged Zyprexa SS ORAL STRENGHT = 7.5 MG TAKEN IN THE EVENING. Zyprexa SS ORAL STRENGHT= 10 MG TAKEN IN THE EVENING. Depakote SS ORAL Barnetil C Date:08/01/03ISR Number: 4159734-9Report Type:Direct Company Report #CTU 199083 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Zyprexa 2.5mg PS 2.5MG/DAY Intervention to Second Degree Potassium Chloride C Prevent Permanent Bradycardia Haldol C Impairment/Damage Date:08/01/03ISR Number: 4162137-4Report Type:Expedited (15-DaCompany Report #2003024982 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Zeldox (Capsules) Initial or Prolonged Hypertensive Crisis Health (Ziprasidone) PS ORAL 60 MG (BID), Restlessness Professional ORAL Treatment Noncompliance Olanzapine (Olanzapine) SS 5 MG (DAILY) 24-Jun-2005 12:19 PM Page: 2410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/03ISR Number: 4204481-8Report Type:Periodic Company Report #2002AP03626 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amitriptyline PS Intentional Misuse Health Olanzapine SS Professional Clonazepam SS Date:08/01/03ISR Number: 4205389-4Report Type:Periodic Company Report #2002AP03626 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amitriptyline PS Intentional Misuse Health Olanzapine SS Professional Clonazepam SS Date:08/04/03ISR Number: 4160291-1Report Type:Expedited (15-DaCompany Report #PHBS2003JP05265 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Melleril PS Novartis Sector: Hospitalization - Prolonged Pharma ORAL 200 mg/d Initial or Prolonged Intentional Misuse Melleril SS Novartis Sector: Suicide Attempt Pharma ORAL Ventricular Fibrillation Zyprexa SS ORAL 80 mg/d Ventricular Tachycardia Zyprexa SS ORAL Date:08/04/03ISR Number: 4160616-7Report Type:Direct Company Report #CTU 199145 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Strattera 120 PS Dysarthria Zyprexa 7.5 SS Dysthymic Disorder Prozac 40 SS Family Stress Mood Altered Date:08/04/03ISR Number: 4160696-9Report Type:Direct Company Report #CTU 199192 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Zyprexa PS ORAL ORAL Hospitalization - Feeling Cold Risperdal SS ORAL ORAL Initial or Prolonged Glasgow Coma Scale Required Abnormal Intervention to Neuroleptic Malignant Prevent Permanent Syndrome Impairment/Damage Oxygen Saturation Decreased Pneumonia Aspiration Respiratory Arrest Vomiting 24-Jun-2005 12:19 PM Page: 2411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/03ISR Number: 4161070-1Report Type:Direct Company Report #CTU 199151 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Strattera Eli Lilly PS Eli Lilly MORNING EVENING Zyprexa SS WAS TOLD THEY WERE USUALLY USED TOGETHER Date:08/04/03ISR Number: 4161260-8Report Type:Direct Company Report #USP 50186 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Pfizer Zyprexa SS Lilly Date:08/04/03ISR Number: 4164201-2Report Type:Expedited (15-DaCompany Report #HQWYE801530JUN03 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mass Health Avlocardyl Life-Threatening Neutrophil Count Professional (Propranolol Hospitalization - Increased Other Hydrochloride, Initial or Prolonged Pancreatitis Acute Tablet) PS ORAL 1 DF DAILY Renal Failure Haldol (Haloperidol) SS ORAL Paracetamol (Paracetamol) SS ORAL Veinamitol (Troxerutin) SS Zyprexa (Olanzapine) SS ORAL 5 MG 1X PER 1 DAY 10 DAY Zyrtec (Cetirizine Hydrochloride) SS Date:08/04/03ISR Number: 4164414-XReport Type:Expedited (15-DaCompany Report #DEU-2003-0000507 Age:69 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Anaemia Other Arrhythmia Blood Creatine Phosphokinase Increased Cardiac Murmur Cerebral Atrophy Confusional State Drug Interaction Encephalopathy General Physical Health Deterioration Hyperhidrosis Lung Infection Miosis Nausea Neuroleptic Malignant Syndrome Overdose Paraneoplastic Syndrome 24-Jun-2005 12:19 PM Page: 2412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Rales Renal Cyst Report Source Product Role Manufacturer Route Dose Duration Renal Failure Foreign Ms Contin PS ORAL 90 MG, DAILY, Tachycardia Health ORAL Professional Zyprexa (Olanzapine) SS ORAL 5 MG, DAILY, Other ORAL Rivotril (Clonazepam) SS ORAL 1 MG, DAILY, ORAL Halcion (Triazolam) SS ORAL 0.25 MG, DAILY, ORAL Zofran (Ondansetron Hydrochloride) C Primperan C Co-Reniten (Enalapril Maleate, Hydrochlorothiazide) C Prepulsid (Cisapride) C Acetylsalicylic Acid C Antra (Omeprazole) C Movicol (Macrogol, Sodium Chloride, Potassium Chloride, Sodium Bicarbonate) C Microklist (Sorbitol, Sodium Citrate, Sodium Lauryl Sulfoacetate) C Date:08/05/03ISR Number: 4164684-8Report Type:Expedited (15-DaCompany Report #US_020987604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Zyprexa-Oral Initial or Prolonged Pregnancy Professional (Olanzapine) Psychotic Disorder Company (Olanzapine) PS Representative Date:08/05/03ISR Number: 4164689-7Report Type:Expedited (15-DaCompany Report #USA030742307 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa-Oral Other Dizziness Professional (Olanzapine) Loss Of Consciousness Company (Olanzapine) PS 5 MG/DAY Representative Geodon(Ziprasidone Hydrochloride) C Date:08/05/03ISR Number: 4164731-3Report Type:Expedited (15-DaCompany Report #US_030796404 Age:46 YR Gender:Male I/FU:I Outcome PT Death Abdominal Distension Other Brain Oedema Coma Diabetic Ketoacidosis 24-Jun-2005 12:19 PM Page: 2413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastrointestinal Disorder Gastrointestinal Oedema Hepatic Failure Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Consumer Zyprexa-Oral Hypokalaemia Other (Olanzapine) Hypotension (Olanzapine) PS 15 MG/DAY Intestinal Infarction Gemfibrozil C Multi-Organ Failure Amlodipine Besilate C Pulse Absent Hydrochlorothiazide C Renal Failure Acute Benzatropine Respiratory Arrest Mesilate C Respiratory Failure Rhabdomyolysis Date:08/05/03ISR Number: 4165014-8Report Type:Expedited (15-DaCompany Report #JP_030701422 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa-Oral Initial or Prolonged Glucose Tolerance Health (Olanzapine) Impaired Professional (Olanzapine) PS 20 MG/DAY Glucose Urine Present Company Risperdal(Risperidon Representative e) C Other Tolopelon (Timiperone) C Landsen (Clonazepam) C Bufferin C Omeprazon (Omeprazole) C Myslee (Zolpidem Tartrate) C Solon (Sofalcone) C Magnesium Oxide C Date:08/05/03ISR Number: 4165016-1Report Type:Expedited (15-DaCompany Report #GBS030713442 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Olanzapine-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) PS 10 MG Psychotic Disorder Professional Depixol(Flupentixol Other Decanoate) C Date:08/05/03ISR Number: 4165017-3Report Type:Expedited (15-DaCompany Report #GBS030713441 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Olanzapine-Oral Initial or Prolonged Blood Creatinine Health (Olanzapine) PS 10 MG Blood Sodium Professional Bendrofluazide C Blood Urea Other Citalopram C Circulatory Collapse Candesartan C Dehydration Aspirin C Electrolyte Imbalance Zopiclone C 24-Jun-2005 12:19 PM Page: 2414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/03ISR Number: 4165018-5Report Type:Expedited (15-DaCompany Report #GBS030713429 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Olanzapine-Oral Health (Olanzapine) PS 2.5 MG Professional Prozac (Fluoxetine Other Hydrochloride) C Date:08/05/03ISR Number: 4165021-5Report Type:Expedited (15-DaCompany Report #FR_030702727 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermographism Foreign Zyprexa-Oral Face Oedema Health (Olanzapine) Respiratory Disorder Professional (Olanzapine) PS 30 MG/DAY Urticaria Other Depakine Chrono C Effexor (Venlafaxine Hydrochloride) C Seresta (Oxazepam) C Lepticur (Tropatepine Hydrochloride) C Dafalgan (Paracetamol) C Diane C Date:08/05/03ISR Number: 4165022-7Report Type:Expedited (15-DaCompany Report #EWC030735732 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Dispersib Increased Health le (Olanzapine) PS 20 MG/DAY Aspartate Professional Aminotransferase Company Increased Representative Blood Alkaline Other Phosphatase Increased Cholestasis Gamma-Glutamyltransferase Increased Hepatic Steatosis Date:08/05/03ISR Number: 4165024-0Report Type:Expedited (15-DaCompany Report #EWC030735638 Age:69 YR Gender:Male I/FU:I Outcome PT Death Anaemia Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Confusional State Disease Progression Drug Interaction Encephalopathy General Physical Health Deterioration Hydronephrosis Nausea Neuroleptic Malignant 24-Jun-2005 12:19 PM Page: 2415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Paraneoplastic Syndrome Pyrexia Renal Cyst Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG/DAY Professional Mst Other Continus(Morphine Sulfate) C Rivotril(Clonazepam) C Halcion(Triazolam) C Zofran(Ondansetron Hydrochloride) C Primperan(Metoclopra mide) C Co-Reniten C Prepulsid(Cisapride) C Cardioaspirine(Acety lsalicylic Acid) C Antra(Omeprazole) C Movicol C Microklist C Date:08/05/03ISR Number: 4165498-5Report Type:Expedited (15-DaCompany Report #USA030742255 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Zyprexa-Oral Spinal Cord Disorder Professional (Olanzapine) Swelling Company (Olanzapine) PS 5 MG Representative Date:08/05/03ISR Number: 4165500-0Report Type:Expedited (15-DaCompany Report #USA030742180 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amputation Health Zyprexa-Oral Drug Toxicity Professional (Olanzapine) Overdose Company (Olanzapine) PS 15 MG/DAY 3 YR Suicide Attempt Representative Coumadin (Warfarin Sodium) C Date:08/05/03ISR Number: 4165501-2Report Type:Expedited (15-DaCompany Report #USA030742175 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) Body Temperature (Olanzapine) PS 20 MG/DAY Increased Topamax (Topiramate) C Date:08/05/03ISR Number: 4165504-8Report Type:Expedited (15-DaCompany Report #USA030741953 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Consumer Zyprexa-Oral Other Heart Rate Increased (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Adderall C Trazadone (Trazodone) C Marijuana C Wellbutrin (Bupropion Hydrochloride) C Date:08/05/03ISR Number: 4165506-1Report Type:Expedited (15-DaCompany Report #2003028963 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Foreign Lipitor Initial or Prolonged Alanine Aminotransferase Health (Atorvastatin) PS ORAL 10 MG Aspartate Professional (DAILY), ORAL Aminotransferase Risperidone Blood Bilirubin (Risperidone) SS ORAL 4 MG (DAILY), Blood Glucose Increased ORAL Blood Lactate Olanzapine Dehydrogenase (Olanzapine) SS ORAL 10 MG Blood Triglycerides (DAILY), ORAL Increased Vegetamin A Blood Urea Increased (Phenobarbital, C-Reactive Protein Promethazine, Drug Eruption Chlorpromazine Gamma-Glutamyltransferase Hydrochloride) SS ORAL 12.5 MG/12.5 Haemoglobin MG/30 MG Hepatic Function Abnormal (DAILY), ORAL Hypersensitivity Vegetamin A Infection (Phenobarbital, Insomnia Promethazine, Liver Disorder Chlorpromazine Platelet Count Hydrochloride) SS ORAL 25 MG/12.5 Pyrexia MG/40 MG Rash (DAILY), ORAL White Blood Cell Count Allopurinol (Allopurinol) SS ORAL 100 MG (DAILY), ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Cloxazolam (Cloxazolam) C Date:08/05/03ISR Number: 4165711-4Report Type:Expedited (15-DaCompany Report #S03-UKI-03135-01 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Cipramil (Citalopram Initial or Prolonged Blood Creatinine Health Hydrobromide) PS ORAL 10 MG QD PO Blood Urea Professional Bendrofluazide SS ORAL 2.5 MG QD PO Circulatory Collapse Other Olanzapine SS ORAL 5 MG QD PO Dehydration Candesartan C Electrolyte Imbalance Aspirin Bayer Hyponatraemia (Acetylsalicylic Acid) C Zopiclone C 24-Jun-2005 12:19 PM Page: 2417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/03ISR Number: 4162569-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041363A Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Quilonum Retard PS Glaxosmithkline ORAL Initial or Prolonged Hypothermia Taxilan SS ORAL Loss Of Consciousness Godamed SS Glaxosmithkline ORAL Clozapine SS ORAL Akineton SS ORAL Pirenzepin SS ORAL Dominal Forte SS ORAL Lorazepam SS ORAL Chlorprothixen SS ORAL Rivotril SS ORAL Orfiril SS ORAL Zyprexa SS ORAL Topamax SS ORAL Seroquel SS ORAL Date:08/06/03ISR Number: 4164874-4Report Type:Expedited (15-DaCompany Report #JP_030701227 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa-Oral Cardiac Failure Health (Olanzapine) Cardio-Respiratory Arrest Professional (Olanzapine) PS 20 MG/DAY Cerebral Atrophy Company Risperdal Drug Effect Decreased Representative (Risperidone) C Drug Interaction Other Ganaton (Itopride Fall Hydrochloride) C Feeling Abnormal Cetilo C Malaise Risumic (Amezinium Medication Error Metilsulfate) C Sudden Death Vegetamin A C Ventricular Fibrillation Lendormin (Brotizolam) C Pursennid (Senna Leaf) C Yodel (Senna) C Date:08/06/03ISR Number: 4164908-7Report Type:Expedited (15-DaCompany Report #FLUV00303001761 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akathisia Foreign Depromel 25 Other Condition Aggravated Health (Fluvoxamine Dystonia Professional Maleate) PS ORAL 50 MG DAILY Extrapyramidal Disorder Other PO Mental Disorder Zyprexa (Olanzapine) SS ORAL 2.5 MG DAILY Respiratory Arrest PO Suicidal Ideation Permax (Pergolide Temperature Regulation Mesilate) SS ORAL 750 MCG DAILY Disorder PO Vocal Cord Disorder Symmetrel (Amantadine Hydrochloride) C Pantosin (Pantethine) C Madopar (Levodopa/Benserazid 24-Jun-2005 12:19 PM Page: 2418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report e Hydrochloride) C Magnesium Oxide (Magnesium Oxide) C Thyradin S (Levothyroxine Sodium) C Aspara (Aspartate Potassium) C Date:08/06/03ISR Number: 4165922-8Report Type:Expedited (15-DaCompany Report #EWC030735509 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Blood Lactate Professional (Olanzapine) PS 7.5 MG Dehydrogenase Increased Company Effexor -Xr Blood Triglycerides Representative (Venlafaxine Increased Other Hydrochloride) C Cerebrovascular Accident Akton (Cloxazolam) C Diabetes Mellitus Isoten (Bisoprolol Inadequate Control Fumarate) C Ejection Fraction Ethyrone Decreased (Levothyroxine Gamma-Glutamyltransferase Sodium) C Increased Glycosylated Haemoglobin Hepatic Enzyme Increased Hyperglycaemia Hypokinesia Low Density Lipoprotein Increased Date:08/06/03ISR Number: 4165923-XReport Type:Expedited (15-DaCompany Report #DE_030511317 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Twitching Foreign Zyprexa Velotab-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 10 MG IN THE Other EVENING Date:08/06/03ISR Number: 4165924-1Report Type:Expedited (15-DaCompany Report #EWC030133632 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Decreased Foreign Olanzapine - Oral Leukocytoclastic Health (Olanzapine) PS 15 MG/DAY Vasculitis Professional Combivent C Petechiae Other Prednison(Prednisone Respiratory Tract ) C Infection Seretide Diskus C Theophylline C Lorazepam C 24-Jun-2005 12:19 PM Page: 2419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/03ISR Number: 4165925-3Report Type:Expedited (15-DaCompany Report #FR_020701174 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrested Labour Foreign Zyprexa-Oral Initial or Prolonged Caesarean Section Health (Olanzapine) Complications Of Maternal Professional (Olanzapine) PS 10 MG/DAY Exposure To Therapeutic Other Parlodel Drugs (Bromocriptine Conjunctivitis Mesilate) C Delirium Foetal Growth Retardation Hypertonia Jaundice Maternal Drugs Affecting Foetus Phlebitis Pre-Eclampsia Tremor Date:08/06/03ISR Number: 4165926-5Report Type:Expedited (15-DaCompany Report #FR_030602559 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-Oral Initial or Prolonged International Normalised Health (Olanzapine) Ratio Decreased Professional (Olanzapine) PS 15 MG/DAY Phlebitis Other Levothyrox White Blood Cell Count (Levothyroxine Decreased Sodium) C Aspegic (Acetylsalicylate Lysine) C Mopral (Omeprazole) C Transipeg (Macrogol) C Fraxodi (Nadroparin Calcium) C Previscan (Fluindione) C Date:08/06/03ISR Number: 4165933-2Report Type:Expedited (15-DaCompany Report #CA_030606052 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Increased Foreign Olanzapine-Oral Hospitalization - Diabetic Ketoacidosis Study (Olanzapine) PS 10 MG/AT Initial or Prolonged Health BEDTIME Professional Sertraline C Other Date:08/07/03ISR Number: 4166180-0Report Type:Expedited (15-DaCompany Report #HQWYE903305AUG03 Age:40 YR Gender:Male I/FU:I Outcome PT Death Cardiac Arrest Cardiomyopathy Circulatory Collapse Hypocalcaemia Hypokalaemia 24-Jun-2005 12:19 PM Page: 2420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Shock Health Efexor (Venlafaxine Professional Hydrochloride, Other Tablet) PS ORAL ORAL Clozaril SS ORAL 200 MG 1X PER 1 DAY, ORAL Epilim (Valproate Sodium) SS ORAL ORAL Olanzapine SS ORAL ORAL Date:08/08/03ISR Number: 4167533-7Report Type:Expedited (15-DaCompany Report #M0798-2003 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glasgow Coma Scale Health Mirtazapine PS DF Initial or Prolonged Abnormal Professional Risperidone SS DF Hypotension Venlafaxine SS DF Radicular Syndrome Olanzapine SS Somnolence Lormetazepam C Suicide Attempt Prothipendyl Tachycardia Hydrochloride C Date:08/12/03ISR Number: 4166941-8Report Type:Direct Company Report #CTU 199881 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Aleve Naproxen Initial or Prolonged Restlessness (Otc) PS OTC Somnolence Zyprexa Olanzapine SS Speech Disorder Date:08/12/03ISR Number: 4168158-XReport Type:Expedited (15-DaCompany Report #USA030537857 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Carotid Artery Occlusion Health Zyprexa-Oral Initial or Prolonged Condition Aggravated Professional (Olanzapine) Other Hypoperfusion Company (Olanzapine) PS 2.5 MG/DAY Nervous System Disorder Representative Date:08/12/03ISR Number: 4168480-7Report Type:Expedited (15-DaCompany Report #USA030742833 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Fluoxetine C Zocor (Simvastatin) C 24-Jun-2005 12:19 PM Page: 2421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/03ISR Number: 4168482-0Report Type:Expedited (15-DaCompany Report #USA030742892 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:08/12/03ISR Number: 4168484-4Report Type:Expedited (15-DaCompany Report #USA030843024 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:08/12/03ISR Number: 4168486-8Report Type:Expedited (15-DaCompany Report #USA030843032 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Seroquel (Quetiapine Fumarate) C Paxil (Paroxetine Hydrochloride) C Trazadone (Trazodone) C Soma (Carisoprodol) C Date:08/12/03ISR Number: 4168506-0Report Type:Expedited (15-DaCompany Report #USA030742439 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Strattera Initial or Prolonged Weight Increased (Atomoxetine Hydrochloride) PS 6 MON Zyprexa-Oral (Olanzapine) SS 10 MG/DAY 6 MON Depakote (Valproate Semisodium) C Date:08/12/03ISR Number: 4168514-XReport Type:Expedited (15-DaCompany Report #USA030742201 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Urine Consumer Zyprexa Body Temperature Zydis-Disperisble Decreased (Olanzapine) Feeling Cold (Olanzapine) PS 15 MG Insomnia Wellbutrin Thinking Abnormal (Bupropion Hydrochloride) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 2422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/03ISR Number: 4168516-3Report Type:Expedited (15-DaCompany Report #USA030742432 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Maternal Drugs Affecting Consumer Zyprexa-Oral Foetus (Olanzapine) Trisomy 21 (Olanzapine) PS Date:08/12/03ISR Number: 4168518-7Report Type:Expedited (15-DaCompany Report #USA030742579 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Health Zyprexa-Oral Initial or Prolonged Attack Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:08/12/03ISR Number: 4168520-5Report Type:Expedited (15-DaCompany Report #USA030742703 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 20 MG Representative Date:08/12/03ISR Number: 4168628-4Report Type:Expedited (15-DaCompany Report #US_030796404 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Consumer Zyprexa-Oral Other Coma Other (Olanzapine) Diabetic Ketoacidosis (Olanzapine) PS 15 MG/DAY Gastrointestinal Oedema Gemfibrozil C Hyperglycaemia Amlodipine Besilate C Hypokalaemia Hydrochlorothiazide C Hypotension Benzatropine Intestinal Infarction Mesilate C Liver Disorder Liver Function Test Abnormal Multi-Organ Failure Pulse Absent Renal Failure Acute Respiratory Arrest Respiratory Failure Rhabdomyolysis Shock Date:08/12/03ISR Number: 4168842-8Report Type:Expedited (15-DaCompany Report #US_030796627 Age:24 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Ascites Diarrhoea Gastroenteritis Haemoglobin Hepatic Function Abnormal 24-Jun-2005 12:19 PM Page: 2423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatomegaly Lymphocyte Count Nausea Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Foreign Olanzapine-Oral Portal Hypertension Consumer (Olanzapine) PS 20 MG/DAY Red Blood Cell Count Other Clonazepam C Reticulocyte Percentage Splenomegaly White Blood Cell Count Date:08/12/03ISR Number: 4168843-XReport Type:Expedited (15-DaCompany Report #EWC030835805 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cerebral Haemorrhage Foreign Zyprexa-Oral Coma Study (Olanzapine) Road Traffic Accident Health (Olanzapine) PS 10 MG/DAY Professional Eurodin (Estazolam) C Other Date:08/12/03ISR Number: 4168846-5Report Type:Expedited (15-DaCompany Report #DE_030711757 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Zyprexa-Oral Initial or Prolonged Blood Prolactin Increased Health (Olanzapine) Galactorrhoea Professional (Olanzapine) PS 30 MG/DAY Prescribed Overdose Company Truxal Representative (Chlorprothixene Other Hydrochloride) C Date:08/12/03ISR Number: 4168890-8Report Type:Expedited (15-DaCompany Report #JP_030701422 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glucose Tolerance Foreign Zyprexa-Oral Initial or Prolonged Impaired Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Risperdal Representative (Risperidone) C Other Tolopelon (Timiperone) C Landsen (Clonazepam) C Bufferin C Omeprazon (Omeprazole) C Myslee (Zolpidem Tartrate) C Solon (Sofalcone) C Magnesium Oxide C Date:08/12/03ISR Number: 4168957-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706419 Age:73 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Dehydration Foreign Risperdal Endocarditis Health (Risperidone) Extrapyramidal Disorder Professional Tablets PS ORAL ORAL Myoglobinuria Zyprexia Pancytopenia (Olanzapine) Tablets SS ORAL 15 MG, ORAL Psychotic Disorder Haldol (Haloperidol) Pyrexia Unspecified SS 2 MG, 3 IN 1 Rhabdomyolysis DAY Belok Zok (Metoprolol Succinate) SS 95 MG, 1 IN 1 DAY Norvasc (Amlodipine Besilate) SS ORAL 5 MG, 2 IN 1 DAY, ORAL Xanef (Enalapril Maleate) Tablets SS ORAL ORAL Tavor (Lorazepam) SS ORAL 0.5 MG, 3 IN 1 DAY, ORAL Vibolex (B-Komplex "Leciva") Capsules SS ORAL 300 MG, 2 IN 1 DAY, ORAL Hydrochlorothiazide C Molsidomin (Molsidomine) C Kalinor (Potassium Chloride) C Dytide H (Dyazide) C Kepinol (Bactrim) C Corvaton Ret. (Molsidomine) C Date:08/12/03ISR Number: 4168964-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706419 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Other Endocarditis Professional Tablets PS ORAL ORAL Extrapyramidal Disorder Zyprexia General Physical Health (Olanzapine) Tablets SS ORAL 15 MG, ORAL Deterioration Haldol (Haloperidol) SS 2 MG, 3 IN 1 Pancytopenia DAY Rhabdomyolysis Belok Zok (Metoprolol Succinate) SS 95 MG, 1 IN 1 DAY Norvasc (Amlodipine Besilate) SS ORAL 5 MG, 2 IN 1 DAY, ORAL Xanef (Enalapril Maleate) Tablets SS ORAL ORAL Tavor (Lorazepam) SS ORAL 0.5 MG, 3 IN 1 DAY, ORAL Vibolex (B-Komplex "Leciva") Capsules SS ORAL 300 MG, 2 IN 1 DAY, ORAL 24-Jun-2005 12:19 PM Page: 2425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochlorothiazide (Hydrochlorothiazide ) C Molsidomin (Molsidomine) C Kalinor (Potassium Chloride) C Dytide H (Dyazide) Tablets C Kepinol (Bactrim) C Corvaton Ret. (Molsidomine) Tablets C Date:08/12/03ISR Number: 4169159-8Report Type:Expedited (15-DaCompany Report #DE_030711766 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Zyprexa-Oral Initial or Prolonged General Physical Health Health (Olanzapine) Deterioration Professional (Olanzapine) PS 20 MG/DAY Hyperthyroidism Other Corvaton - Slow Hypokalaemia Release Hyponatraemia (Molsidomine) C Pancytopenia Dytide C Psychotic Disorder Haldol Rhabdomyolysis "Janssen-Cilag" Urinary Tract Infection (Haloperidol) C Kepinol C Mono Embolex (Heparin) C Alpha-Vibolex (Thioctic Acid) C Kalinor-Brausetablet ten C Beloc Zok (Metoprolol Succinate) C Norvasc (Amlodipine Besilate) C Xanef (Enalapril Maleate) C Tavor (Lorazepam) C Date:08/12/03ISR Number: 4169162-8Report Type:Expedited (15-DaCompany Report #US_030796240 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Culture Positive Foreign Olanzapine-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) PS 10 MG/DAY Gastric Disorder Professional Levomepromazine C Gram Stain Negative Other Trifluoperazine C Metrorrhagia 24-Jun-2005 12:19 PM Page: 2426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/03ISR Number: 4169180-XReport Type:Expedited (15-DaCompany Report #EWC030735641 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Zyprexa-Oral Initial or Prolonged Lymphoproliferative Health (Olanzapine) Disorder Professional (Olanzapine) PS 7.5 MG/DAY Thrombocytopenia Other Altiazem(Diltiazem Hydrochloride) C Cardiovasc (Lercanidipine Hydrochloride) C Mepral (Omeprazole) C Rivotril(Clonazepam) C Candesartan C Date:08/12/03ISR Number: 4169182-3Report Type:Expedited (15-DaCompany Report #JP_030400701 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Decreased Foreign Zyprexa-Oral Epistaxis Health (Olanzapine) Granulocytopenia Professional (Olanzapine) PS 10 MG/DAY Pallor Company Depakene (Valproate Platelet Count Decreased Representative Sodium) C Other Limas(Lithium Carbonate) C Rohypnol (Flunitrazepam) C Benzalin (Nitrazepam) C Date:08/12/03ISR Number: 4169184-7Report Type:Expedited (15-DaCompany Report #GBS030713359 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Zyprexa-Oral Other Circulatory Collapse Health (Olanzapine) Convulsion Professional (Olanzapine) PS 20 MG/DAY Death Company Methadone C Disturbance In Attention Representative Pulse Absent Other Respiratory Distress Ventricular Fibrillation Date:08/12/03ISR Number: 4169186-0Report Type:Expedited (15-DaCompany Report #GBS030713339 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Olanzapine-Oral Other Deep Vein Thrombosis Health (Olanzapine) PS 15 MG/UNKNOWN Pulmonary Embolism Professional Lithium C Company Zuclopenthixol C Representative Melatonin C Other Lorazepam C 24-Jun-2005 12:19 PM Page: 2427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/03ISR Number: 4169188-4Report Type:Expedited (15-DaCompany Report #EWC030735732 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Dispersib Increased Health le (Olanzapine) PS 20 MG/DAY Aspartate Professional Aminotransferase Company Increased Representative Blood Alkaline Other Phosphatase Increased Cholestasis Gamma-Glutamyltransferase Increased Hepatic Steatosis Date:08/12/03ISR Number: 4169190-2Report Type:Expedited (15-DaCompany Report #CA_030606033 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa Hospitalization - Agitation Health Zydis-Dispersible Initial or Prolonged Arrhythmia Professional (Olanzapine) Blood Creatine Company (Olanzapine) PS 20 MG Phosphokinase Representative Cardiac Disorder Other Condition Aggravated Confusional State Hostility Muscle Rigidity Pyrexia Date:08/12/03ISR Number: 4169191-4Report Type:Expedited (15-DaCompany Report #JP_030701335 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Injury Asphyxiation Health (Olanzapine) Irritability Professional (Olanzapine) PS 15 MG/DAY Company Risperdal(Risperidon Representative e) C Other Amoban(Zopiclone) C Eurodin(Estazolam) C Sennoside A+B C Date:08/13/03ISR Number: 4166836-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06906 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Zelnorm PS Novartis Sector: Drug Ineffective Pharma ORAL 6 mg, BID 18720MIN Hypersensitivity Zyprexa SS Suicidal Ideation Zestril C UNK, UNK Tremor 24-Jun-2005 12:19 PM Page: 2428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/03ISR Number: 4166996-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU00506 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL 25 mg, UNK Initial or Prolonged Loss Of Consciousness Clozaril (Clozapine) SS Novartis Sector: Other Sudden Death Pharma ORAL 50 mg, BID Urinary Incontinence Clozaril (Clozapine) SS Novartis Sector: Pharma 137.5 mg, UNK Oxazepam C 60 mg, QD Diazepam I ORAL 10 mg, TID Olanzapine I ORAL 10 mg, UNK Olanzapine I UNK, UNK Date:08/14/03ISR Number: 4168122-0Report Type:Direct Company Report #USP 50047 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa PS Lilly TAB Dipentum SS Pharmacia CAPSULE Date:08/14/03ISR Number: 4168124-4Report Type:Direct Company Report #USP 50048 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly TABLET Zyrtec SS Pfizer TABLET Date:08/14/03ISR Number: 4168159-1Report Type:Expedited (15-DaCompany Report #PHBS2003JP05265 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Melleril PS Novartis Sector: Hospitalization - Consciousness Pharma ORAL 200 mg/d Initial or Prolonged Electrocardiogram Qt Melleril SS Novartis Sector: Prolonged Pharma ORAL 20 tablets, Intentional Misuse ONCE/SINGLE Suicide Attempt Zyprexa SS ORAL 80 mg/d Ventricular Fibrillation Zyprexa SS ORAL 16 tablets, Ventricular Tachycardia ONCE/SINGLE Date:08/14/03ISR Number: 4169359-7Report Type:Expedited (15-DaCompany Report #2003105626 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Adhesions Health Benadryl Initial or Prolonged Abdominal Distension Professional (Diphenhydramine) PS ORAL ORAL Abdominal Pain Upper Olanzapine Constipation (Olanzapine) SS ORAL 20 MG QD, Nausea ORAL Small Intestinal Benzatropine Mesilae Obstruction (Benzatropine Vomiting Mesilate) SS ORAL ORAL Hydrochlorothiazide (Hydrochlorothiazide ) C Amlodipine Besilate 24-Jun-2005 12:19 PM Page: 2429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amlodipine Besilate) C Atorvastatin (Atorvastatin) C Benzatropine (Benzatropine) C Montelukast Sodium (Montelukast Sodium) C Haloperidol (Haloperidol) C Date:08/15/03ISR Number: 4168651-XReport Type:Expedited (15-DaCompany Report #DK-GLAXOSMITHKLINE-B0305937A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Lamictal PS Glaxosmithkline YR Initial or Prolonged Dizziness Olanzapine SS Fall Citalopram SS Oedema Lithium Carbonate C Glaxosmithkline Parkinson'S Disease Pimozide C Weight Increased Date:08/15/03ISR Number: 4168659-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041664A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Quilonum Retard PS Glaxosmithkline ORAL 6750MG per Multiple Drug Overdose day Somnolence Meto Isis SS ORAL 4000MG per Suicide Attempt day Zyprexa SS ORAL 175MG per day Diazepam SS ORAL 350MG per day Date:08/15/03ISR Number: 4170069-0Report Type:Direct Company Report #CTU 200069 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zyprexa PS 10MGS 2X A DAY Date:08/15/03ISR Number: 4170957-5Report Type:Direct Company Report #USP 042142 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly Zyrtec SS Pfizer Date:08/18/03ISR Number: 4172985-2Report Type:Expedited (15-DaCompany Report #03P-056-0209096-00 Age:31 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Ammonia Increased Anticonvulsant Drug Level Above Therapeutic Aspartate 24-Jun-2005 12:19 PM Page: 2430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Confusional State Glasgow Coma Scale Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Foreign Depakote Tablets Suicide Attempt Health (Depakote) Tachycardia Professional (Divalproex Sodium) Company (Divalproex Sodium) PS ORAL 15 G, 30 Representative TABLETS AT ONCE, ORAL Olanzapine SS ORAL 28 TABLETS AT ONCE, ORAL Alprazolam SS ORAL 7.5 MG AT ONCE, ORAL Ethanol SS Date:08/19/03ISR Number: 4169854-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291266 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Tequin PS Bristol-Myers Squibb Drug Interaction Company Depakote I Zyprexa I Date:08/19/03ISR Number: 4172547-7Report Type:Expedited (15-DaCompany Report #USA030843373 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Strattera Initial or Prolonged Overdose Professional (Atomoxetine Suicide Attempt Company Hydrochloride) PS 3280 MG Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 140 MG Date:08/19/03ISR Number: 4173258-4Report Type:Expedited (15-DaCompany Report #USA030742810 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa-Oral Prolonged Professional (Olanzapine) (Olanzapine) PS Clonidine C Wellbutrin(Bupropion Hydrochloride) C Date:08/19/03ISR Number: 4173260-2Report Type:Expedited (15-DaCompany Report #USA030843498 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Zyprexa-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS Other Representative 24-Jun-2005 12:19 PM Page: 2431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/03ISR Number: 4173262-6Report Type:Expedited (15-DaCompany Report #USA030843435 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Wound Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:08/19/03ISR Number: 4173692-2Report Type:Expedited (15-DaCompany Report #GBS030713359 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Zyprexa-Oral Other Circulatory Collapse Health (Olanzapine) Convulsion Professional (Olanzapine) PS 20 MG/DAY Disturbance In Attention Company Methadone C Dyspnoea Representative Ventricular Fibrillation Other Date:08/19/03ISR Number: 4173693-4Report Type:Expedited (15-DaCompany Report #GBS030513124 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Olanzapine-Oral Other Brain Oedema Health (Olanzapine) PS 20 MG/1 DY Cardiomegaly Professional Depixol (Flupentixol Depressed Level Of Other Decanoate) C Consciousness Zopiclone C Drug Screen Positive Drug Toxicity Foreign Body Aspiration Hepatic Congestion Hepatitis C Laboratory Test Interference Liver Disorder Malaise Pulmonary Alveolar Haemorrhage Self-Injurious Ideation Suicidal Ideation Ventricular Hypertrophy Date:08/19/03ISR Number: 4173694-6Report Type:Expedited (15-DaCompany Report #DE_030711757 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Zyprexa-Oral Initial or Prolonged Blood Prolactin Increased Literature (Olanzapine) Galactorrhoea Company (Olanzapine) PS 30 MG/DAY Prescribed Overdose Representative Truxal Other (Chlorprothixene Hydrochloride) C Anafranil (Clomipramine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/03ISR Number: 4173695-8Report Type:Expedited (15-DaCompany Report #EWC030635357 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Zyprexa-Oral Brain Oedema Health (Olanzapine) Completed Suicide Professional (Olanzapine) PS OTHER 560 MG/OTHER Drug Toxicity Other Overdose Toxicologic Test Abnormal Date:08/19/03ISR Number: 4173734-4Report Type:Expedited (15-DaCompany Report #EWC030825819 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Olanzapine-Oral Hospitalization - Complete Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Bradycardia Professional Nozinan Cardiac Arrest Other (Levomepromazine) C Date:08/19/03ISR Number: 4173792-7Report Type:Expedited (15-DaCompany Report #DE_030611520 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Foreign Zyprexa Velotab Oral Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS 20 MG/DAY Chills Company Cipramil (Citalopram Confusional State Representative Hydrobromide) C Dyskinesia Other Rivotril Dyspnoea (Clonazepam) C Extrapyramidal Disorder Tavor (Lorazepam) C Hyperhidrosis Ximovan (Zopiclone) C Myoglobin Blood Increased Tachycardia Tachypnoea Date:08/19/03ISR Number: 4173821-0Report Type:Expedited (15-DaCompany Report #JP_030500928 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acoustic Neuroma Foreign Zyprexa-Oral Initial or Prolonged Dizziness Study (Olanzapine) Gait Disturbance Health (Olanzapine) PS 5 MG/DAY Professional Emilace Other (Nemonapride) C Artane (Trihexyphenidyl Hydrochloride) C Tegretol (Carbamazepine) C Gascon (Dimeticone) C Politose C Benzalin (Nitrazepam) C Alosenn C 24-Jun-2005 12:19 PM Page: 2433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/03ISR Number: 4174292-0Report Type:Expedited (15-DaCompany Report #HQWYE956607AUG03 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Depression Health Vandral (Venlafaxine Initial or Prolonged Respiratory Failure Professional Hydrochloride, Other Tablet) PS ORAL 37.5 MG 1X PER 1 DAY ORAL Deprax (Trazodone Hydrochloride, ) SS ORAL 50 MG 1X PER 1 DAY ORAL Dormodor (Flurazepam Hydrochloride, ) SS ORAL 30 MG 1X PER 1 DAY ORAL Lexatin (Bromazepam, ) SS ORAL 3 MG 1X PER 1 DAY ORAL Zyprexa (Olanzapine, ) SS ORAL 5 MG 1X PER 1 DAY ORAL Date:08/19/03ISR Number: 4174720-0Report Type:Expedited (15-DaCompany Report #JP_030801507 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercapnia Foreign Zyprexa-Oral Initial or Prolonged Respiratory Depression Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Company Wintermin Representative (Chlorpromazine Other Hydrochloride) C Date:08/19/03ISR Number: 4174721-2Report Type:Expedited (15-DaCompany Report #GBS030813497 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Olanzapine-Oral Initial or Prolonged Oedema Health (Olanzapine) PS 20 MG Ventricular Dysfunction Professional Lithium C Other Diazepam C Clomipramine C Date:08/19/03ISR Number: 4174722-4Report Type:Expedited (15-DaCompany Report #JP_030801496 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Zyprexa-Oral Road Traffic Accident Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Tasmolin Representative (Bisperiden) C Other 24-Jun-2005 12:19 PM Page: 2434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/03ISR Number: 4174723-6Report Type:Expedited (15-DaCompany Report #GBS030813487 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intestinal Obstruction Foreign Olanzapine-Oral Volvulus Of Bowel Health (Olanzapine) PS 2.5 MG/2 DAY Professional Madopar C Other Venlafaxine C Co-Amilofruse C Date:08/19/03ISR Number: 4174724-8Report Type:Expedited (15-DaCompany Report #EWC030835869 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Rupture Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Other Date:08/19/03ISR Number: 4174725-XReport Type:Expedited (15-DaCompany Report #CA_030806143 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Clonazepam C Effexor (Venlafaxine Hydrochloride) C Lamotrigine C Date:08/21/03ISR Number: 4176551-4Report Type:Expedited (15-DaCompany Report #HQWYE956607AUG03 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Depression Health Vandral (Venlafaxine Hospitalization - Respiratory Failure Professional Hydrochloride, Initial or Prolonged Other Tablet) PS ORAL 37.5 MG 1X PER 1 DAY Deprax (Trazodone Hydrochloride, ) SS ORAL 50 MG 1X PER 1 DAY Dormoor (Flurazepam Hydrochloride, ) SS ORAL 30 MG 1X PER 1 DAY Lexatin (Bromazepam, ) SS ORAL 3 MG 1X PER 1 DAY Zyprexa (Olanzapine, ) SS ORAL 5 MG 1X PER 1 DAY Date:08/22/03ISR Number: 4171994-7Report Type:Expedited (15-DaCompany Report #PHEH2003US06906 Age:74 YR Gender:Female I/FU:F Outcome PT Other Dizziness Drug Hypersensitivity 24-Jun-2005 12:19 PM Page: 2435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Ineffective Suicidal Ideation Tremor Report Source Product Role Manufacturer Route Dose Duration Zelnorm PS Novartis Sector: Pharma ORAL 6 mg, BID 18720MIN Zyprexa SS Zestril C UNK, UNK Date:08/25/03ISR Number: 4172638-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-344813 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Diazepam PS Roche ORAL Drug Interaction Remeron I ORAL Drug Level Increased Remeron I ORAL 42 DAY Respiratory Depression Zyprexa I ORAL 42 DAY Sudden Death Stilnox I ORAL Date:08/25/03ISR Number: 4173878-7Report Type:Direct Company Report #CTU 200627 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Zyprexa 2.5mg PS ORAL 2.5MG QD ORAL Intervention to Increased Prevent Permanent Impairment/Damage Date:08/25/03ISR Number: 4173936-7Report Type:Direct Company Report #CTU 200635 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Zyprexa 20mg PS ORAL 20MG DAILY Intervention to Increased ORAL Prevent Permanent Impairment/Damage Date:08/25/03ISR Number: 4177655-2Report Type:Expedited (15-DaCompany Report #M0438-2003 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Mirtazapine PS ORAL 15 MG/30 MG, Cardiac Failure Professional ORAL 616 WKY Drug Level Increased Olanzapine SS ORAL 2.5 MC, ORAL 6 WK Diazepam SS ORAL ORAL Zolpidem SS ORAL ORAL ... C Date:08/26/03ISR Number: 4174966-1Report Type:Direct Company Report #CTU 200720 Age:45 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 2436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Autonomic Nervous System Zyprexa 20 Mg PS ORAL 20 MG PO Imbalance DAILY Depressed Level Of Decadron C Consciousness Mavik C Neuroleptic Malignant Celexa C Syndrome Coumadin C Renal Failure Acute Phenergan C Respiratory Failure Levaquin C Rhabdomyolysis Xanax C Zofran C Ferrous Gluc C Percocet C Date:08/26/03ISR Number: 4175008-4Report Type:Direct Company Report #CTU 200729 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Olanzapine 7.5qhs PS Initial or Prolonged Weight Increased Date:08/26/03ISR Number: 4178593-1Report Type:Expedited (15-DaCompany Report #EWC011129004 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Calmaxid Initial or Prolonged Abdominal Pain Upper Health (Nizatidine) PS 300 MG/DAY Other Adenoma Benign Professional Zyprexa-Oral Anaemia Other (Olanzapine) Benign Hepatic Neoplasm (Olanzapine) SS 20 MG/DAY C-Reactive Protein Ludiomil Increased (Maprotiline Change Of Bowel Habit Hydrochloride) C Diverticulitis Quilonorm (Lithium Granulomatous Liver Acetate) C Disease Haematoma Hepatic Infarction Hepatic Necrosis Liver Abscess Salpingitis Vasculitis Weight Increased Date:08/26/03ISR Number: 4178674-2Report Type:Expedited (15-DaCompany Report #JP_030701335 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Injury Asphyxiation Health (Olanzapine) Persecutory Delusion Professional (Olanzapine) PS 15 MG/DAY Company Risperdal Representative (Risperidone) C Other Amoban (Zopiclone) C Eurodin (Estazolam) C Sennoside A+B C 24-Jun-2005 12:19 PM Page: 2437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/03ISR Number: 4178675-4Report Type:Expedited (15-DaCompany Report #DE_030711766 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Dehydration Health (Olanzapine) Delusional Disorder, Professional (Olanzapine) PS 20 MG/DAY Persecutory Type Other Corvaton - Slow Hyperthyroidism Release(Molsidomine) C Hypokalaemia Dytide C Hyponatraemia Haldol Pancytopenia "Janssen-Cilag"(Halo Rhabdomyolysis peridol) C Somnolence Kepinol C Urinary Tract Infection Mono Embolex(Heparin) C Alpha-Vibolex(Thioct ic Acid) C Kalinor-Brausetablet ten C Beloc Zok(Metoprolol Succinate) C Norvasc(Amlodipine Besilate) C Xanef(Enalapril Maleate) C Tavor(Lorazepam) C Date:08/26/03ISR Number: 4178676-6Report Type:Expedited (15-DaCompany Report #DE_030711757 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Zyprexa-Oral Initial or Prolonged Galactorrhoea Health (Olanzapine) Prescribed Overdose Professional (Olanzapine) PS 30 MG/DAY Company Truxal(Chlorprothixe Representative ne Hydrochloride) C Other Anafranil(Clomiprami ne Hydrochloride) C Date:08/26/03ISR Number: 4178809-1Report Type:Expedited (15-DaCompany Report #US_030695107 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Health Strattera Hospitalization - Blood Ph Decreased Professional (Atomoxetine Initial or Prolonged Blood Urea Company Hydrochloride) PS 80 MG/DAY Confusional State Representative Zyprexa-Oral Dehydration (Olanzapine) Dry Mouth (Olanzapine) SS 30 MG/DAY Glycosylated Haemoglobin Clonazepam C Increased Nausea Polydipsia Polyuria Vomiting 24-Jun-2005 12:19 PM Page: 2438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/03ISR Number: 4178874-1Report Type:Expedited (15-DaCompany Report #JP_030801579 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Foreign Zyprexa-Oral Blood Creatine Health (Olanzapine) Phosphokinase Professional (Olanzapine) PS 20 MG/DAY Blood Lactate Company Dehydrogenase Representative Gamma-Glutamyltransferase Other Hepatic Function Abnormal Micturition Disorder Date:08/26/03ISR Number: 4178878-9Report Type:Expedited (15-DaCompany Report #EWC030835893 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa-Oral Initial or Prolonged Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS 12.5 MG Confusional State Other Tranxene Depressed Level Of (Clorazepate Consciousness Dipotassium) C Dysphagia Nozinan Extrapyramidal Disorder (Levomepromazine) C Neuroleptic Malignant Tritace (Ramipril) C Syndrome Pyrexia Salivary Hypersecretion Somnolence White Blood Cell Count Increased Date:08/26/03ISR Number: 4179365-4Report Type:Expedited (15-DaCompany Report #EWC030835884 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Depression Foreign Zyprexa-Oral Respiratory Failure Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Lexatin (Bromazepam) C Dormodor (Flurazepam Hydrochloride) C Vandral (Venlafaxine Hydrochloride) C Deprax (Trazodone Hydrochloride) C Trazodone C Date:08/26/03ISR Number: 4179366-6Report Type:Expedited (15-DaCompany Report #AU_030806555 Age:38 YR Gender:Female I/FU:I Outcome PT Hospitalization - Body Temperature Initial or Prolonged Increased Hyperhidrosis Leukocytosis Musculoskeletal Stiffness Myocarditis 24-Jun-2005 12:19 PM Page: 2439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachypnoea Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Zoloft C Representative Other Date:08/26/03ISR Number: 4179367-8Report Type:Expedited (15-DaCompany Report #DE_030811833 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Foreign Zyprexa-Oral Refusal Of Treatment By Health (Olanzapine) Patient Professional (Olanzapine) PS 20 MG/DAY Other Tavor (Lorazepam) C Orfiril - Slow Release(Valproate Sodium) C Date:08/26/03ISR Number: 4179369-1Report Type:Expedited (15-DaCompany Report #DE_030811834 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Tavor (Lorazepam) C Date:08/26/03ISR Number: 4179466-0Report Type:Expedited (15-DaCompany Report #FR_030802802 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Hypertrophy Foreign Zyprexa-Oral Initial or Prolonged Cardiomegaly Health (Olanzapine) Electrocardiogram St-T Professional (Olanzapine) PS 10 MG/DAY Segment Abnormal Other Solian(Amisulpride) C Malaise Sinus Tachycardia Ventricular Hypertrophy Date:08/26/03ISR Number: 4179517-3Report Type:Expedited (15-DaCompany Report #DE_030711645 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Zyprexa-Oral Initial or Prolonged Positive Health (Olanzapine) Pemphigus Professional (Olanzapine) PS 10 MG/1 IN Red Blood Cell Other THE EVENING 6 YR Sedimentation Rate Increased Type Iii Immune Complex Mediated Reaction 24-Jun-2005 12:19 PM Page: 2440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/03ISR Number: 4179614-2Report Type:Expedited (15-DaCompany Report #USA030844090 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Zyprexa-Oral Initial or Prolonged Delusional Disorder, Professional (Olanzapine) Other Unspecified Type (Olanzapine) PS 20 MG Drug Effect Decreased Date:08/26/03ISR Number: 4179616-6Report Type:Expedited (15-DaCompany Report #US_030695122 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Consumer Zyprexa-Oral Initial or Prolonged Blood Creatine (Olanzapine) Other Blood Potassium (Olanzapine) PS 10 MG/AT Blood Sodium BEDTIME Blood Urea Haldol (Haloperidol) C Circulatory Collapse Depakote (Valproate Diabetes Mellitus Semisodium) C Non-Insulin-Dependent Glucophage Diabetic Coma (Metformin Motor Dysfunction Hydrochloride) C Movement Disorder Glucotrol Xl Vomiting (Glipizide) C White Blood Cell Count Seroquel (Quetiapine Fumarate) C Date:08/26/03ISR Number: 4179617-8Report Type:Expedited (15-DaCompany Report #US_030897001 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Literature Olanzapine-Oral Initial or Prolonged Imbalance Health (Olanzapine) PS 10 MG/DAY 3 DAY Blood Creatine Professional Cefazolin C Phosphokinase Increased Blood Pressure Decreased Delirium Dysphagia Hypotension Lymphocyte Count Monocytosis Pyrexia Sinus Tachycardia White Blood Cell Count Increased Date:08/27/03ISR Number: 4176062-6Report Type:Direct Company Report #CTU 200831 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Olanzapine PS ORAL 10 MG DAILY PO 24-Jun-2005 12:19 PM Page: 2441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4176078-XReport Type:Direct Company Report #CTU 200835 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obesity Olanzapine PS ORAL 40 MG DAILY PO Gabapentin C Thiothixene C Topiramate C Date:08/27/03ISR Number: 4179518-5Report Type:Expedited (15-DaCompany Report #DE_030611567 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Zyprexa-Oral Initial or Prolonged Thrombosis Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Risperdal (Risperidone) C Date:08/28/03ISR Number: 4175108-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12273769 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL Started on 5mg/Increased to 10mg on 22-Apr-2003 Lorazepam C ORAL Had taken for "many" years/started a slow taper 1 week prior Gabitril C ORAL 8 MON Lexapro C ORAL 6 WK Zyprexa I ORAL Dose was increased to 15mg from 10mg in the past month 1 YR Date:08/28/03ISR Number: 4176139-5Report Type:Direct Company Report #CTU 200867 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Zyprexa 2x 10 Mg And Hospitalization - 2 X 5 Mg /Day Eli Initial or Prolonged Lilly PS Eli Lilly ORAL 30 MG DIVIDED Required ORAL Intervention to Chlorpromazine 100 Prevent Permanent Mg Udl SS Udl ORAL 100 MG DAILY Impairment/Damage AT HS ORAL Calcium Carb C Levothyroxine C Nicotine Patch C Acetaminophen C 24-Jun-2005 12:19 PM Page: 2442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187741-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12336426 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Abilify Tabs 10 Mg PS Otsuka Overdose Pharmaceutical Company, Ltd. Effexor Xr SS Zyprexa SS Date:08/29/03ISR Number: 4182264-5Report Type:Expedited (15-DaCompany Report #DSA_23158_2003 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Foreign Tavor PS 20 MG ONCE Hospitalization - Intentional Misuse Health Zyprexa SS 35 MG ONCE Initial or Prolonged Tachycardia Professional Other Date:09/02/03ISR Number: 4178852-2Report Type:Direct Company Report #CTU 201094 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Valproic Acid 500 Mg PS ORAL 2500 MG QD 2 Hospitalization - Diabetes Mellitus AM, 3 ORAL Initial or Prolonged Diabetic Ketoacidosis Olanzapine 5 Mg SS ORAL 5 MG BID ORAL Required Pancreatitis Propranolol C Intervention to Fluvoxamine C Prevent Permanent Seroquel C C Impairment/Damage Docusate C Date:09/02/03ISR Number: 4183541-4Report Type:Expedited (15-DaCompany Report #2003-02548 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Road Traffic Accident Health Trazodone (Watson Professional Laboratories) (Trazodone Hydrochloride) Tablet PS Watson Laboratories ORAL 250 MG, QHS, ORAL Klonopin (Clonazepam) SS ORAL 1 MG, QHS, ORAL Prozac (Fluoxetine Hydrochloride) SS ORAL 60 MG, DAILY, ORAL Zyprexa (Olanzapine) SS ORAL 5 MG, DAILY, ORAL Flexeril (Cyclobenzaprine Hydrochloride) 10mg SS ORAL 10 MG, Q8H, ORAL 24-Jun-2005 12:19 PM Page: 2443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4177726-0Report Type:Expedited (15-DaCompany Report #PHBS2001NZ09465 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - Drug Interaction Pharma ORAL 200 mg/day 47520MIN Initial or Prolonged Valproate Sodium C UNKNOWN 1500 mg/day Combivent C UNKNOWN Synermox C Olanzapine I UNKNOWN 10 mg/day Date:09/03/03ISR Number: 4178021-6Report Type:Expedited (15-DaCompany Report #CH-ROCHE-345203 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Rivotril PS Roche ORAL Initial or Prolonged Drug Interaction Dafalgan C ORAL Hyperammonaemia Xanax C UNKNOWN Loss Of Consciousness Depakine Chrono I ORAL Lamictal I ORAL Fluctine I ORAL Zyprexa I ORAL Date:09/03/03ISR Number: 4178080-0Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0307782A Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Lamictal PS Glaxosmithkline ORAL 100MG Per day 2 YR Initial or Prolonged Disorientation Depakine SS ORAL 500MG Twice Fall per day Hyperammonaemia Fluctine SS ORAL 20MG Per day Loss Of Consciousness Zyprexa SS ORAL 5MG Per day Urinary Incontinence Rivotril SS ORAL .5MG Three times per day Dafalgan C Glaxosmithkline ORAL 500MG Six times per day Alprazolam C 1MG per day Date:09/03/03ISR Number: 4178084-8Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041664A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Quilonum Retard PS Glaxosmithkline ORAL 6750MG per Initial or Prolonged Distress Syndrome day Aspiration Meto Isis SS ORAL 4000MG per Bradycardia day Intentional Misuse Zyprexa SS ORAL 175MG per day Loss Of Consciousness Diazepam SS ORAL 350MG per day Pneumonia Somnolence Suicide Attempt Date:09/03/03ISR Number: 4184490-8Report Type:Expedited (15-DaCompany Report #USA030844633 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Ankle Fracture Consumer Zyprexa-Oral Clavicle Fracture (Olanzapine) Collapse Of Lung (Olanzapine) PS 10 MG/DAY Memory Impairment Altace (Ramipril) C Pelvic Fracture Lexapro Rib Fracture (Escitalopram) C Road Traffic Accident Upper Limb Fracture Date:09/03/03ISR Number: 4184492-1Report Type:Expedited (15-DaCompany Report #USA030844471 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Zyprexa-Oral Loss Of Consciousness Professional (Olanzapine) Periorbital Haematoma Company (Olanzapine) PS 10 MG Road Traffic Accident Representative Tegretol (Carbamazepine) C Xanax (Alprazolam) C Date:09/03/03ISR Number: 4184497-0Report Type:Expedited (15-DaCompany Report #USA030844383 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Hospitalization - Ketoacidosis Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 40 MG/DAY 7 MON Representative Depakote (Valproate Semisodium) C Date:09/03/03ISR Number: 4184695-6Report Type:Expedited (15-DaCompany Report #USA030844485 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malignant Neoplasm Health Zyprexa-Oral Progression Professional (Olanzapine) PS Muscle Spasms Company Representative Date:09/03/03ISR Number: 4184701-9Report Type:Expedited (15-DaCompany Report #USA030844300 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative 24-Jun-2005 12:19 PM Page: 2445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4184703-2Report Type:Expedited (15-DaCompany Report #US_030897132 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Literature Olanzapine-Oral(Olan Electrocardiogram Qt Health zapine) PS 60 MG/DAY Corrected Interval Professional Chlorpromazine C Prolonged Quetiapine C Date:09/03/03ISR Number: 4184720-2Report Type:Expedited (15-DaCompany Report #GBS030813579 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 17.5 MG/ Other Lower Respiratory Tract Professional Mirtazapine C Infection Other Chlordiazepoxide C Renal Impairment Date:09/03/03ISR Number: 4184722-6Report Type:Expedited (15-DaCompany Report #JP_030801622 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Company Representative Other Date:09/03/03ISR Number: 4184725-1Report Type:Expedited (15-DaCompany Report #JP_030801624 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disseminated Foreign Zyprexa-Oral Disability Intravascular Coagulation Health (Olanzapine) Other Heart Rate Decreased Professional (Olanzapine) PS 5 MG/DAY Lung Infection Company Vancomycin-Iv Pseudomonal Representative (Vancomycin) Pneumonia Staphylococcal Other (Vancomycin Respiratory Failure Hydrochloride SS Harnal(Tamsulosin Hydrochloride) C Biofermin C Sm Powder C Clarith(Clarithromyc in) C Isodine Gargle(Iodine) C Fungizone(Amphoteric in B) C Lendormin(Brotizolam ) C Magnesium Oxide C Lactec C Methylprednisolone Sodium Succinate C Carbenin C Aminofluid C 24-Jun-2005 12:19 PM Page: 2446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glunon(Glucose) C Atarax(Hydroxyzine Hydrochloride) C Serenace(Haloperidol ) C Solita-T3 Injection C Date:09/03/03ISR Number: 4184730-5Report Type:Expedited (15-DaCompany Report #JP_030801625 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Lactate Foreign Zyprexa-Oral Life-Threatening Dehydrogenase Increased Health (Olanzapine) Blood Pressure Decreased Professional (Olanzapine) PS 5 MG/1 AT C-Reactive Protein Company BEDTIME Increased Representative Predonine Coma Other (Prednisolone) C Delirium Gatifloxacin C Fall Mucosta (Rebamipide) C Heart Rate Decreased Baktar C Mydriasis Silece Oxygen Saturation (Flunitrazepam) C Decreased Myslee (Zolpidem Pallor Tartrate) C Pneumonia Aspiration Pneumothorax Respiratory Arrest White Blood Cell Count Increased Date:09/03/03ISR Number: 4184733-0Report Type:Expedited (15-DaCompany Report #JP_030801637 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:09/03/03ISR Number: 4184734-2Report Type:Expedited (15-DaCompany Report #EWC030835948 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchiolitis Foreign Olanzapine-Oral Bronchitis Health (Olanzapine) PS 2.5 MG/DAY Cardiac Disorder Professional Remeron(Mirtazapine) C Cardiac Failure Other Stilnox(Zolpidem) C Drug Interaction Diazepam C Haemorrhage Hypoxia Lung Disorder Respiratory Depression 24-Jun-2005 12:19 PM Page: 2447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4184738-XReport Type:Expedited (15-DaCompany Report #FR_030802824 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coronary Artery Foreign Zyprexa-Oral Thrombosis Health (Olanzapine) Myocardial Infarction Professional (Olanzapine) PS 1 DSG Other FORM/DAY Trimetazidine C Sermion(Nicergoline) C Tanakan(Ginkgo Biloba Extract) C Cokenzen C Date:09/03/03ISR Number: 4184739-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030700011 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Risperdal Initial or Prolonged Pulmonary Embolism Health (Risperidone) Weight Increased Professional Unspecified PS ORAL SEE IMAGE Marcumar (Phenprocoumon) SS Zyprexa (Olanzapine) SS ORAL 30 MG 1 IN 1 DAY ORAL Nizak (Nizatidine) C Pantozol (Pantoprazole Sodium) C Date:09/03/03ISR Number: 4184744-5Report Type:Expedited (15-DaCompany Report #FR_030702684 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Foreign Zyprexa Increased Health Blood Uric Acid Increased Professional (Olanzapine) PS 20 MG/DAY Calcinosis Company Seropram (Citalopram Cytolytic Hepatitis Representative Hydrobromide) C Hypertension Other Temesta (Lorazepam) C Weight Increased Lepticur (Tropatepine Hydrochloride) C Haldol (Haloperidol) C Date:09/03/03ISR Number: 4184745-7Report Type:Expedited (15-DaCompany Report #JP_030801507 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Foreign Zyprexa Hospitalization - Coma Health Initial or Prolonged Constipation Professional (Olanzapine) PS ORAL 2.5 MG/DAY Hypercapnia Company Wintermin Respiratory Depression Representative (Chlorpromazine Respiratory Failure Other Hydrochloride) C Gaster (Famotidine) C Primperan(Metoclopra mide) C Bisolvon 24-Jun-2005 12:19 PM Page: 2448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bromphexine Hydrochloride) C Ciproxan (Ciprofloxacin Hydrochloride) C Rohypnol (Flunitrazepam) C Serenace (Haloperidol) C Lasix (Furosemide) C Selbex (Terprenone) C Mucosolvan (Ambroxol Hydrochloride) C Date:09/03/03ISR Number: 4184758-5Report Type:Expedited (15-DaCompany Report #DE_030611567 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - International Normalised Foreign Zyprexa Initial or Prolonged Ratio Abnormal Health (Olanzapine) PS 15 MG/DAY Pulmonary Embolism Professional Risperdal Thrombosis Other (Risperidone) C Weight Decreased Date:09/03/03ISR Number: 4184760-3Report Type:Expedited (15-DaCompany Report #EWC030835884 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Failure Foreign Zyprexa Health (Olanzapiene) PS ORAL 5 MG/DAY Professional Lexatin (Bromazepam) C Other Dormodor (Flurazepam Hydrochloride) C Vndral (Venlafaxine Hydrochloride) C Deprax (Trazodone Hydrochloride) C Trazodone C Date:09/03/03ISR Number: 4184762-7Report Type:Expedited (15-DaCompany Report #JP_030500883 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Olanzapine Initial or Prolonged Alanine Aminotransferase Study Aspartate Health (Olanzapine) PS ORAL 10 MG/DAY Aminotransferase Professional Miradol (Sulpiride) C Blood Bilirubin Other Biperiden C Blood Lactate Serenace Dehydrogenase (Haloperidol) C Bowel Sounds Abnormal Parkin (Profenamine) C Difficulty In Walking Halcion (Triazolam) C Flatulence Pursennide (Senna Hepatic Function Abnormal Leaf) C Ileus Adalat L Oral Intake Reduced (Nifedipine) C Gaster (Famotidine) C 24-Jun-2005 12:19 PM Page: 2449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4184765-2Report Type:Expedited (15-DaCompany Report #JP_030701385 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Zyprexa Initial or Prolonged Hypertension Study (Olanzapine) PS ORAL 10 MG/DAY Osteoarthritis Health Linton (Haloperidol) C Weight Increased Professional Tasmolin (Biperiden) C Other Gasmotin (Mosapride Citrate) C Kolantyl C Gaster (Famotidine) C Thyradin S (Levothyroxine Sodium) C Infree (Indometacin) C Silece (Flunitrazepam) C Date:09/03/03ISR Number: 4185139-0Report Type:Expedited (15-DaCompany Report #DSA_23146_2003 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Tavor PS ORAL 25 MG ONCE PO Initial or Prolonged Tachycardia Health Zyprexa SS ORAL 140 MG ONCE Tremor Professional PO Other Eunerpan SS ORAL 2500 MG ONCE PO Remergil SS ORAL 48 TAB ONCE PO Paroxetine SS ORAL 1000 MG ONCE PO Date:09/08/03ISR Number: 4185670-8Report Type:Expedited (15-DaCompany Report #200303853 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Imprisonment Consumer Flexeril 10mg Initial or Prolonged Memory Impairment Other Tablets 10 Mg/Tablet PS ORAL 10 MG Q8H PO Road Traffic Accident Klonopin SS ORAL 1 MG HS PO Prozac SS ORAL 60 MG QD PO Trazodone SS ORAL 250 MG HS PO Zyprexa SS ORAL 5 MG BID PO Date:09/09/03ISR Number: 4186592-9Report Type:Direct Company Report #CTU 201516 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Olanzapine PS Initial or Prolonged Tachycardia Vomiting Date:09/09/03ISR Number: 4187412-9Report Type:Expedited (15-DaCompany Report #US_021189448 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Blood Alkaline 24-Jun-2005 12:19 PM Page: 2450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphatase Increased Decreased Appetite Gamma-Glutamyltransferase Increased Report Source Product Role Manufacturer Route Dose Duration Gastric Mucosal Lesion Foreign Olanzapine-Oral Haematemesis Study (Olanzapine) PS 20 MG DAY Hepatic Cirrhosis Health Wintermin Hepatic Function Abnormal Professional (Chlorpromazine Hypoglycaemia Other Hydrochloride) C Hypoproteinaemia Linton (Haloperidol) C Iron Deficiency Anaemia Tasmolin (Biperiden) C Orthostatic Hypotension Pantosin Prurigo (Pantethine) C White Blood Cell Count Hirnamin Increased (Levomepromazine) C Lendormin (Brotizolam) C Halcion (Triazolam) C Magnesium Oxide C Pursennid (Senna Leaf) C Sodium Picosulfate C Lexin (Carbamazepine) C Dogmatyl (Sulpiride) C Date:09/09/03ISR Number: 4187413-0Report Type:Expedited (15-DaCompany Report #JP_030801496 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Foreign Zyprexa-Oral Constipation Health (Olanzapine) Fall Professional (Olanzapine) PS 20 MG/DAY Gait Disturbance Company Tasmolin (Biperiden) C Representative Other Date:09/09/03ISR Number: 4187414-2Report Type:Expedited (15-DaCompany Report #JP_030801507 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Foreign Zyprexa-Oral Hospitalization - Coma Health (Olanzapine) Initial or Prolonged Constipation Professional (Olanzapine) PS 2.5 MG/DAY Hypercapnia Company Wintermin Respiratory Failure Representative (Chlorpromazine Other Hydrochloride) C Gaster (Famotidine) C Gaster (Famotidine) C Primperan (Metoclopramide) C Bisolvon (Bromhexine Hydrochloride) C Ciproxsan (Ciprofloxacin Hydrochloride) C Rohypnol (Flunitrazepam) C Serenace (Haloperidol) C 24-Jun-2005 12:19 PM Page: 2451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix (Furosemide) C Selbex (Teprenone) C Mucosolvan (Ambroxol Hydrochloride) C Date:09/09/03ISR Number: 4187417-8Report Type:Expedited (15-DaCompany Report #JP_030801622 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Other Convulsion Health (Olanzapine) Gaze Palsy Professional (Olanzapine) PS 2.5 MG/D AT Respiratory Depression Company BEDTIME Representative Date:09/09/03ISR Number: 4187418-XReport Type:Expedited (15-DaCompany Report #EWC030735575 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Blood Creatine Professional (Olanzapine) PS 10 MG/DAY Phosphokinase Mb Other Increased Condition Aggravated Date:09/09/03ISR Number: 4187419-1Report Type:Expedited (15-DaCompany Report #FR_030802824 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coronary Artery Foreign Zyprexa-Oral Atherosclerosis Health (Olanzapine) Coronary Artery Professional (Olanzapine) PS 1 DSG Thrombosis Other FORM/DAY Myocardial Infarction Trimetazidine C Sermion (Nicergoline) C Tanakan (Ginkgo Biloba Extract) C Cokenzen C Date:09/09/03ISR Number: 4187422-1Report Type:Expedited (15-DaCompany Report #JP_030801624 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Respiratory Foreign Zyprexa-Oral Disability Failure Health (Olanzapine) Other Condition Aggravated Professional (Olanzapine) PS 5 MG/DAY Coombs Direct Test Company Vancomycin-Iv Positive Representative (Vancomycin) Disseminated Other (Vancomycin Intravascular Coagulation Hydrochloride) SS Heart Rate Decreased Harnal(Tamsulosin Lung Infection Hydrochloride) C Pseudomonal Biofermin C Pneumonia Staphylococcal Sm Powder C Respiratory Failure Clarith(Clarithromyc 24-Jun-2005 12:19 PM Page: 2452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report in) C Isodine Gargle(Iodine) C Fungizone(Amphoteric in B) C Lendormin(Brotizolam ) C Magnesium Oxide C Lactec C Methylprednisolone Sodium Succinate C Carbenin C Aminofluid C Glunon(Glucose) C Atarax(Hydroxyzine Hydrochloride) C Serenace(Haloperidol ) C Solita-T3 Injection C Date:09/09/03ISR Number: 4187424-5Report Type:Expedited (15-DaCompany Report #JP_030801625 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Lactate Foreign Zyprexa-Oral Life-Threatening Dehydrogenase Increased Health (Olanzapine) Disability Blood Pressure Decreased Professional (Olanzapine) PS 5 MG/1 AT C-Reactive Protein Company BEDTIME Increased Representative Predonine(Prednisolo Cardiac Failure Other ne) C Cardio-Respiratory Arrest Gatifloxacin C Delirium Mucosta(Rebamipide) C Fall Baktar C Heart Rate Decreased Silece(Flunitrazepam Injury Asphyxiation ) C Mydriasis Myslee(Zolpidem Oxygen Saturation Tartrate) C Decreased Pallor Pneumonia Aspiration Pneumothorax White Blood Cell Count Increased Date:09/09/03ISR Number: 4187425-7Report Type:Expedited (15-DaCompany Report #JP_030801637 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Oral Infarction Health (Olanzapine)(Olanzap Blood Pressure Decreased Professional ine) PS 5 MG/DAY Cardiac Arrest Company Zyloric Depressed Level Of Representative (Allopurinol) C Consciousness Other Zantac (Ranitidine Pulmonary Embolism Hydrochloride) C Respiratory Arrest Gasmotin(Mosapride Citrate) C Monilac(Lactulose) C Digoxin C Nauzelin(Domperidone 24-Jun-2005 12:19 PM Page: 2453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ) C Topicain(Oxetacaine) C Dogmatyl(Sulpiride) C Myslee(Zolpidem Tartrate) C Voltaren(Diclofenac Sodium) C Aldactone-A(Spironol actone) C Depas(Etizolam) C Azunol(Sodium Gualenate) C Mucodyne(Carbocistei ne) C Gatifloxacin C Tetramide(Mianserin Hydrochloride) C Benzalin(Nitrazepam) C Contomin(Chlorpromaz ine Hydrochloride) C Lactose C Aminofluid C Maxipime(Cefepime Hydrochloride) C Isepacin(Isepamicin Sulfate) C Dalacin-S(Clindamyci n) C Lasix(Furosemide) C Date:09/09/03ISR Number: 4187457-9Report Type:Expedited (15-DaCompany Report #A01200303807 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Stilnox - (Zolpidem) PS ORAL AS NEEDED Decreased Remeron Cardiac Disorder (Mirtazapine) 30 Mg SS ORAL 15 MG/30MG 16 WK Drug Interaction Zyprexa Drug Level Decreased (Olanazapine) SS ORAL 2.5 MG 6 WK Drug Level Increased Diazepam SS ORAL Respiratory Depression Date:09/09/03ISR Number: 4187458-0Report Type:Expedited (15-DaCompany Report #AU_030806643 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Zyprexa-Oral Hospitalization - Myocarditis Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 20 MG/DAY Company Seroquel (Quetiapine Representative Fumarate) SS Other Date:09/09/03ISR Number: 4187909-1Report Type:Expedited (15-DaCompany Report #USA030845002 Age:67 YR Gender:Female I/FU:I Outcome PT Other Breast Mass Circulatory Collapse 24-Jun-2005 12:19 PM Page: 2454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eye Rolling Fall Feeling Abnormal Report Source Product Role Manufacturer Route Dose Duration Head Injury Consumer Zyprexa-Oral Insomnia (Olanzapine) PS 10 M/DAY Loss Of Consciousness Valium (Diazepam) C Ovarian Cancer Fluoxetine Parkinsonian Gait Hydrochloride C Somnolence Date:09/09/03ISR Number: 4187912-1Report Type:Expedited (15-DaCompany Report #USA030845068 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Zyprexa-Oral Professional (Olanzapine) PS Date:09/09/03ISR Number: 4187913-3Report Type:Expedited (15-DaCompany Report #USA030845118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Consumer Zyprexa-Oral Overdose (Olanzapine) PS 5 MG Victim Of Homicide Date:09/09/03ISR Number: 4187915-7Report Type:Expedited (15-DaCompany Report #USA030844952 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Health Zyprexa-Oral Other Deafness Professional (Olanzapine) PS Diabetes Mellitus Coumadin (Warfarin Inadequate Control Sodium) C Memory Impairment Plavix(Clopidogrel Personality Change Sulfate) C Transient Ischaemic Aspirin C Attack Ambien (Zolpidem Tartrate) C Insulin C Date:09/09/03ISR Number: 4188024-3Report Type:Expedited (15-DaCompany Report #USA030845152 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Imprisonment Consumer Prozac-Oral Initial or Prolonged Memory Impairment Other (Fluoxetine) Road Traffic Accident (Fluoxetine Hydrochloride) PS 60 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/2 DAY Trazadone (Trazodone) C Flexeril C Klonopin (Clonazapm) C 24-Jun-2005 12:19 PM Page: 2455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4188029-2Report Type:Expedited (15-DaCompany Report #USA030845625 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG Representative Klonopin (Clonazepam) C Date:09/09/03ISR Number: 4188033-4Report Type:Expedited (15-DaCompany Report #US_030897211 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Maternal Drugs Affecting Consumer Zyprexa-Oral Foetus (Olanzapine) Ventricular Septal Defect (Olanzapine) PS Date:09/09/03ISR Number: 4188062-0Report Type:Expedited (15-DaCompany Report #USA030845460 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:09/09/03ISR Number: 4188100-5Report Type:Expedited (15-DaCompany Report #US_030897250 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acanthosis Nigricans Literature Olanzapine-Oral Initial or Prolonged Blood Cholesterol Health (Olanzapine) PS 10 MG Other Increased Professional Clomipramine C Diabetes Mellitus Citalopram C Hypertriglyceridaemia Trihexyphenidyl C Insulin C-Peptide Methylphenidate C Increased Buspirone C Xanthoma Date:09/09/03ISR Number: 4188106-6Report Type:Expedited (15-DaCompany Report #JP_030801654 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Zyprexa-Oral Consciousness Study (Olanzapine) Water Intoxication Health (Olanzapine) PS 10 MG/DAY Professional Lullan (Perospirone Other Hydrochloride) C Depas (Etizolam) C Setous (Zotepine) C Benzalin (Nitrazepam) C 24-Jun-2005 12:19 PM Page: 2456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4188112-1Report Type:Expedited (15-DaCompany Report #JP_030901700 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa-Oral Initial or Prolonged Delusion Study (Olanzapine) Hallucination Health (Olanzapine) PS 15 MG/DAY Professional Wypax (Lorazepam) C Norvasc (Amlodipine Besilate) C Pursennid (Senna Leaf) C Myslee (Zolpidem Tartrate) C Lendormin (Brotizolam) C Date:09/09/03ISR Number: 4188115-7Report Type:Expedited (15-DaCompany Report #JP_030801665 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Family Stress Health (Olanzapine) Restlessness Professional (Olanzapine) PS Company Representative Other Date:09/09/03ISR Number: 4188123-6Report Type:Expedited (15-DaCompany Report #DE_030811894 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Zyprexa Oral Hospitalization - Anisocytosis Health (Olanzapine) Initial or Prolonged Hypochromasia Professional (Olanzapine) PS 25 MG/DAY Other Tegreatl Retard C Date:09/09/03ISR Number: 4188127-3Report Type:Expedited (15-DaCompany Report #EWC030835992 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Foreign Olanzapine Oral Initial or Prolonged Confusional State Health (Olanzapine) PS 5 MG/DAY Disorientation Professional Fluoxetine-Oral Drug Interaction Other (Fluoxetine) Fall (Fluoxetine Head Injury Hydrochlor SS 20 MG/DAY Loss Of Consciousness Depakine Chrono C Urinary Incontinence Lamictal (Lamotrigine) C Rivotril (Clonazepam) C Dafalgan (Paracetamol) C 24-Jun-2005 12:19 PM Page: 2457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4188131-5Report Type:Expedited (15-DaCompany Report #EWC030936041 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Olanzapine Oral Hospitalization - Choking Consumer (Olanzapine) PS Initial or Prolonged Coma Health Moditen Hypoxia Professional (Fluphenazine Loss Of Consciousness Other Hydrochloride) C Respiratory Arrest Prazine Tension (Hydrochloride) C Tonic Convulsion Akineton (Biperiden Vomiting Hydrochloride) C Date:09/09/03ISR Number: 4188136-4Report Type:Expedited (15-DaCompany Report #USA020717984 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrolyte Imbalance Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine)(Olanzap Other Psychotic Disorder ine) PS 20 MG/D 4 YR Vitamin D Deficiency Risperdal(Risperidon e) C Date:09/09/03ISR Number: 4188156-XReport Type:Expedited (15-DaCompany Report #JP_030801579 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Foreign Zyprexa-Oral Condition Abnormal Health (Olanzapine) Hepatic Function Abnormal Professional (Olanzapine) PS 20 MG/DAY Micturition Disorder Company Representative Other Date:09/09/03ISR Number: 4188299-0Report Type:Expedited (15-DaCompany Report #FR_030802830 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Foreign Zyprexa-Oral Initial or Prolonged Ileus Paralytic Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Other Tercian (Cyamemazine) C Athymil (Mianserin Hydrochloride) C Equanil (Meprobamate) C Date:09/09/03ISR Number: 4188302-8Report Type:Expedited (15-DaCompany Report #GBS030813618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Foreign Olanzapine-Oral Decreased Health (Olanzapine) PS 30 MG/DAY Neutropenia Professional Pindolol C Other Zopiclone C 24-Jun-2005 12:19 PM Page: 2458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/03ISR Number: 4187351-3Report Type:Direct Company Report #CTU 201611 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Zyprexa PS Initial or Prolonged Dysphonia Prozac SS Dystonia Altace C Swollen Tongue Date:09/11/03ISR Number: 4189580-1Report Type:Expedited (15-DaCompany Report #2003036851 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Consumer Zoloft (Sertraline) PS ORAL ORAL Initial or Prolonged Zyprexa (Olanzapine) SS ORAL ORAL Other Date:09/11/03ISR Number: 4189621-1Report Type:Direct Company Report #USP 042170 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zephrex La PS Bock TABLET Zyprexa SS Lilly TABLET Date:09/12/03ISR Number: 4187820-6Report Type:Expedited (15-DaCompany Report #PHEH2003US06906 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Discomfort Zelnorm PS Novartis Sector: Depression Pharma ORAL 6 mg, BID 18720MIN Dizziness Zyprexa SS ORAL 2.5 mg, QD Drug Hypersensitivity Zestril C ORAL 5 mg, QD Drug Ineffective Xanax C ORAL .5 mg, PRN Feeling Abnormal Carafate Suicidal Ideation Tremor /Usa/ C Date:09/16/03ISR Number: 4187008-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0409645A Age:7 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Paxil Cr PS Glaxosmithkline ORAL 12 DAY Initial or Prolonged Drug Interaction Zyprexa SS ORAL 5MG At night Other Excoriation Metadate SS ORAL 22 DAY Hallucination Concerta C ORAL 36MG Twice Hallucination, Auditory per day Laceration Nightmare Psychotic Disorder Self Mutilation Date:09/16/03ISR Number: 4191108-7Report Type:Expedited (15-DaCompany Report #JP_030801622 Age:90 YR Gender:Male I/FU:F Outcome PT Death Cardiac Failure Acute Productive Cough 24-Jun-2005 12:19 PM Page: 2459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Depression Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/L AT Company BEDTIME Representative Other Date:09/16/03ISR Number: 4191113-0Report Type:Expedited (15-DaCompany Report #JP_030801579 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Other Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Company Valerin (Valproate Increased Representative Sodium) C Blood Alkaline Other Rohypnol Phosphatase Increased (Flunitrazepam) C Blood Lactate Pursennid (Senna Dehydrogenase Increased Leaf) C Constipation Magnesium Oxide C Depressed Level Of Gasmotin(Mosapride Consciousness Citrate) C Face Oedema Gamma-Glutamyltransferase Increased Hypoglycaemia Jaundice Liver Disorder Multi-Organ Failure Oedema Peripheral Pneumonia Renal Impairment White Blood Cell Count Decreased Date:09/16/03ISR Number: 4191154-3Report Type:Expedited (15-DaCompany Report #JP_030701422 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Abnormal Foreign Zyprexa Health Professional (Olanzapine) PS ORAL 17.5 MG/DAY Company Risperdal Representative (Risperidone) C Other Tolopelon (Timiperone) C Landsen (Clonazepam) C Bufferin C Myslee (Zolpidem Tartrate) C Solon (Sofalcone) C Magnesuim Oxide C Setous (Zotepine) C Triihexyphenidyl Hydrochloride C 24-Jun-2005 12:19 PM Page: 2460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/03ISR Number: 4191369-4Report Type:Expedited (15-DaCompany Report #HQWYE581909SEP03 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Vandral Retard Syndrome Health (Venlafaxine Professional Hydrochloride, Other Capsule, Extended Release) PS ORAL 300 MG 1X PER 1 DAY 9 DAY Rexer (Mirtazapine) SS ORAL 30 MG 1X PER 1 DAY 11 DAY Sinemet (Carbidopa/Levodopa) SS ORAL 3 DOSE 1X PER 1 DAY Zyprexa (Olanzapine) SS ORAL 20 MG 1X PER 1 DAY 9 DAY Idalprem (Lorazepam) C Date:09/16/03ISR Number: 4192776-6Report Type:Direct Company Report #CTU 201879 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexa 10 Mg PS ORAL 10 MG QHS Initial or Prolonged Phosphokinase Increased ORAL Dehydration Synthroid C Fall Docusate C Tykenol C Eucerin Cream C Date:09/16/03ISR Number: 4192977-7Report Type:Direct Company Report #CTU 201949 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Flomax 0.8 Mg Qd PS 0.8 MG QD Lisinopril 10 Mg Po Qd SS ORAL 10 MG PO QD Zyprexa 10 Po Qd SS ORAL 10 PO QD Date:09/16/03ISR Number: 4193095-4Report Type:Direct Company Report #CTU 201914 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Olanzapine PS 15 MG Q AM AND 20, QHS [LONG TERM] Haloperidol C Benztropine C Date:09/17/03ISR Number: 4191382-7Report Type:Expedited (15-DaCompany Report #JP_030701367 Age:31 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 2461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Alkaline Phosphatase Increased Blood Creatine Report Source Product Role Manufacturer Route Dose Duration Phosphokinase Increased Foreign Zyprexa Blood Lactate Health (Olanzapine) PS ORAL 15MG/DAY Dehydrogenase Increased Professional Akineton (Biperiden C-Reactive Protein Company Hydrochloride) C Increased Representative Rohypnol Gamma-Glutamyltransferase Other (Fluntrazepam) C Increased Magnesium Oxide C Haematocrit Decreased Seroquel (Quetiapine Hyperpyrexia Fumarate) C Liver Disorder Muscle Rigidity Neuroleptic Malignant Syndrome Platelet Count Increased Red Blood Cell Count Decreased Salivary Hypersecretion Tachycardia White Blood Cell Count Increased Date:09/17/03ISR Number: 4191393-1Report Type:Expedited (15-DaCompany Report #US_030997551 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Foreign Olanzapine PS ORAL 5 MG/DAY Hospitalization - Pulmonary Disease Literature Venlafaxine C Initial or Prolonged Deep Vein Thrombosis Health Haloperidol C Dementia Professional Hydroxyzine C Dyspnoea Other Clomethiazole C Infected Skin Ulcer Topical Oesophagitis Corticosteroids C Phlebothrombosis Pulmonary Embolism Urinary Tract Infection Date:09/17/03ISR Number: 4191395-5Report Type:Expedited (15-DaCompany Report #US_030997553 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Olanzapine PS ORAL 5 MG/DAY 44 DAY Literature Melperone C Health Acetylisalicylic Professional Acid C Other Digoxin C Clomethiazole C Valproic Acid C Date:09/17/03ISR Number: 4191413-4Report Type:Expedited (15-DaCompany Report #JP_030701336 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Disability Akinesia Foreign Mutism Study Health 24-Jun-2005 12:19 PM Page: 2462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa -Oral (Olanzapine) (Olanzapine) PS 10 MG/1 DAY Haloperidol C Bromperidol C Cremin (Mosapramine Hydrochloride) C Levotomin (Levomepromazine Maleate) C Biperiden C Benzalin (Nitrazepam0 C Gasmotin (Mosapride Citrate) C Sennoside A C Date:09/17/03ISR Number: 4191433-XReport Type:Expedited (15-DaCompany Report #JP_030601172 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexia-Oral Life-Threatening Phosphokinase Increased Study (Olanzapine) Completed Suicide Health (Olanzapine) PS 2.5 MG/DAY Condition Aggravated Professional Constipation Delusion Hallucination Pigmentation Disorder Rash Papular Date:09/17/03ISR Number: 4191959-9Report Type:Expedited (15-DaCompany Report #JP_030901717 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Risperdal Representative (Risperidone) C Other Solanax (Alprazolam) C Artane (Trihexyphenidyl Hydrochloride) C Date:09/17/03ISR Number: 4192687-6Report Type:Expedited (15-DaCompany Report #USA030845778 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 60 MG/DAY Prozac-Oral (Fluoxetine) (Fluoxetine 24-Jun-2005 12:19 PM Page: 2463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS 30 MG/DAY Xanax (Alprazolam) C Neurontin(Gabapentin ) C Date:09/17/03ISR Number: 4192690-6Report Type:Expedited (15-DaCompany Report #USA030845419 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa-Oral Polymenorrhoea Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY Representative Seroquel (Quetiapine Fumarate) C Date:09/17/03ISR Number: 4192693-1Report Type:Expedited (15-DaCompany Report #USA30946224 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Zyprexa-Oral Initial or Prolonged Urinary Tract Infection Professional (Olanzapine) Other Company (Olanzapine) PS 2 MON Representative Date:09/17/03ISR Number: 4192696-7Report Type:Expedited (15-DaCompany Report #USA030946061 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Laboratory Test Abnormal Consumer Zyprexa-Oral Panic Attack (Olanzapine) (Olanzapine) PS 8 DAY Xanax (Alprazolam) C Mavik (Trandolapril) C Altace (Ramipril) C Zoloft (Sertraline Hydrochloride) C Date:09/17/03ISR Number: 4192738-9Report Type:Expedited (15-DaCompany Report #US_030997518 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Diabetic Ketoacidosis (Olanzapine) PS Haemoptysis Loss Of Consciousness Pulse Absent Respiratory Arrest Date:09/17/03ISR Number: 4192841-3Report Type:Expedited (15-DaCompany Report #CEL-2003-01127-ROC Age:7 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Anxiety Blood Glucose Blood Thyroid Stimulating 24-Jun-2005 12:19 PM Page: 2464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hormone Depression Dissociation Excoriation Report Source Product Role Manufacturer Route Dose Duration Haematocrit Health Metadate Er Haemoglobin Professional (Methylphenidate Hallucination Hydrochloride) PS ORAL 20 MG (20 MG, Hallucination, Auditory DAILY AT 3 Laceration PM), PO Nightmare Zyprexa Platelet Count Increased (Olanzapine) SS ORAL 5 MG (5 MG, Psychotic Disorder HS), PO Red Blood Cell Count Paxil Cr Self Mutilation (Paroxetine White Blood Cell Count Hydrochloride) SS ORAL 12.5 MG (12.5 MG, IN THE MORNING), PO Concerta (Methylphenidate Hydrochloride) SS ORAL 72 MG (72 MG, IN THE MORNING) Date:09/17/03ISR Number: 4193265-5Report Type:Expedited (15-DaCompany Report #JP_030300503 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Drug Ineffective Health (Olanzapine ) Hyperammonaemia Professional (Olanzapine) PS 20MG/DAY Mood Altered Company Levotomin Representative (Levopromazine Other Maleate) C Valerin (Valproate Sodium) C Thyradin S (Levothyroxine Sodium) C Pursennid (Senna Leaf) C Bromperidol C Date:09/17/03ISR Number: 4193266-7Report Type:Expedited (15-DaCompany Report #GBS030713329 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Foreign Olanzapine-Oral Other Coordination Abnormal Health (Olanzapine) PS 15MG Dysarthria Professional Enalapril C Dysphagia Company Bendrofluazide C Dysphasia Representative Influenza Like Illness Other Tremor 24-Jun-2005 12:19 PM Page: 2465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/03ISR Number: 4193358-2Report Type:Expedited (15-DaCompany Report #GBS030913644 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Olanzapine-Oral Initial or Prolonged Dehydration Health (Olanzapine) PS 10 MG Dialysis Professional Sertraline C Neuroleptic Malignant Company Haloperidol C Syndrome Representative Pyrexia Other Renal Failure Acute Stupor Date:09/17/03ISR Number: 4193364-8Report Type:Expedited (15-DaCompany Report #GBS030212550 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decubitus Ulcer Foreign Olanzapine-Oral Hospitalization - Drug Interaction Health (Olanzapine) PS 20 MG Initial or Prolonged Muscle Rigidity Professional Risperidone C Mutism Company Haloperidol C Neuroleptic Malignant Representative Syndrome Other Pulmonary Embolism Pyrexia Date:09/17/03ISR Number: 4193367-3Report Type:Expedited (15-DaCompany Report #GBS030212549 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Olanzapine-Oral Initial or Prolonged Confusional State Health (Olanzapine) PS 20 MG/DAY Other Disinhibition Professional Lithium C Disorientation Company Haloperidol C Irritability Representative Neuroleptic Malignant Other Syndrome Date:09/17/03ISR Number: 4193371-5Report Type:Expedited (15-DaCompany Report #US_030997461 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Zyprexa-Oral Hospitalization - Cardiopulmonary Failure Health (Olanzapine) Initial or Prolonged Cholecystitis Acute Professional (Olanzapine) PS Drug Abuser Other Diazepan (Diazepam) C Haemodialysis Carbamazepine C Haemodynamic Instability Propranolol C Metabolic Acidosis Renal Failure Rhabdomyolysis Thrombocytopenia 24-Jun-2005 12:19 PM Page: 2466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/03ISR Number: 4193385-5Report Type:Expedited (15-DaCompany Report #JP_030901695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Company Representative Date:09/17/03ISR Number: 4193410-1Report Type:Expedited (15-DaCompany Report #EWC030936079 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Foreign Olanzapine-Oral Initial or Prolonged Decreased Health (Olanzapine) PS 20 MG/DAY Other Convulsion Professional Valproate Sodium C Extrapyramidal Disorder Other Biperiden Fall Hydrochloride C Loss Of Consciousness Muscle Spasms Poisoning Tic White Blood Cell Count Decreased Date:09/17/03ISR Number: 4193412-5Report Type:Expedited (15-DaCompany Report #EWC030936051 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholestasis Foreign Olanzapine-Oral Hepatocellular Damage Health (Olanzapine) PS 5 MG/DAY Hypoproteinaemia Professional Tolvon (Mianserin Oedema Peripheral Other Hydrochloride) C Aspro Cardio (Acetylsalicylic Acid) C Serpram (Citalopram Hydrobromide) C Mogadon (Nitrazepam) C Duphalac (Lactulose) C Date:09/17/03ISR Number: 4193413-7Report Type:Expedited (15-DaCompany Report #FR_030902854 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Foreign Zyprexa-Oral Initial or Prolonged Electrocardiogram Qt Health (Olanzapine) Prolonged Professional (Olanzapine) PS 20 MG/DAY Neuroleptic Malignant Other Haldol (Haloperidol) C Syndrome Tercian Neutrophil Count (Cyamemazine) C Troponin Increased Neuleptil (Periciazine) C Lepticur (Tropatepine Hydrochloride) C Sulfarlem (Anethole Trithione) C 24-Jun-2005 12:19 PM Page: 2467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seglor (Dihydroergotamine Mesilate) C Date:09/17/03ISR Number: 4193414-9Report Type:Expedited (15-DaCompany Report #EWC030534798 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Zyprexa-Oral Disease Recurrence Health (Olanzapine) Feeling Abnormal Professional (Olanzapine) PS 20 MG Fistula Other Piportil Hallucination (Pipotizine) C Pulmonary Embolism Leponex (Clozapine) C Haloperidol C Date:09/17/03ISR Number: 4193419-8Report Type:Expedited (15-DaCompany Report #DE_030911952 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cleft Lip Foreign Zyprexa-Oral Hypoglycaemia Neonatal Health (Olanzapine) Maternal Drugs Affecting Professional (Olanzapine) PS 5 MG/DAY Foetus Other Seroquel (Quetiapine Fumarate) C Date:09/17/03ISR Number: 4193420-4Report Type:Expedited (15-DaCompany Report #JP_030901706 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Foreign Zyprexa-Oral Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Company Carbamazepine C Representative Doral (Quazepam) C Other Sennoside C Date:09/17/03ISR Number: 4193428-9Report Type:Expedited (15-DaCompany Report #JP_030300513 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Foreign Zyprexa-Oral Initial or Prolonged Blood Glucose Health (Olanzapine) Other Blood Sodium Professional (Olanzapine) PS 10 MG/DAY Grand Mal Convulsion Company Valerin (Valproate Hyperammonaemia Representative Sodium) C Irritability Other Pursennid (Senna Social Avoidant Behaviour Leaf) C Magnesium Oxide C Risperidone C 24-Jun-2005 12:19 PM Page: 2468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/03ISR Number: 4193508-8Report Type:Expedited (15-DaCompany Report #US_030997554 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Olanzapine-Oral Hospitalization - Depressed Level Of Literature (Olanzapine) PS 5 MG/DAY Initial or Prolonged Consciousness Health Tamoxifen C Other General Physical Health Professional Mirtazapine C Deterioration Other Oxazepam C Hypotension Eltilefrin C Pulmonary Embolism Cyanocobalamin C Sinus Tachycardia Furosemide C Tachypnoea Acetylcysteine C Spironolactone C Lactulose C Date:09/22/03ISR Number: 4193064-4Report Type:Periodic Company Report #S03-USA-00751-01 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Celexa (Citalopram Professional Hydrobromide) PS ORAL 20 MG QD PO Fentanyl SS Alprazolam SS 2 MG QD Trazodone SS 100 MG QD Hydrocodone SS Zyprexa (Olanzapine) SS 10 MG QD Atenolol SS 50 MG QD Date:09/22/03ISR Number: 4193067-XReport Type:Periodic Company Report #S02-USA-01544-01 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Health Celexa (Citalopram Initial or Prolonged Professional Hydrobromide) PS ORAL 20 MG QD PO Zyprexa (Olanzapine) SS 10 MG QD Date:09/22/03ISR Number: 4193846-9Report Type:Expedited (15-DaCompany Report #03P-163-0232426-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Depakote Er 500mg Initial or Prolonged Rash Professional (Depakote Er) Company (Divalproex Sodium) PS ORAL 500 MG, 2 IN Representative 1 D, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 D, PER ORAL Date:09/22/03ISR Number: 4193939-6Report Type:Direct Company Report #CTU 202081 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Difficulty In Walking Zyprexa PS ORAL 5MG-10MG QDAY Required Hepatitis Klonopin C Intervention to Oedema Peripheral Naproxen C Prevent Permanent Skin Ulcer Impairment/Damage Weight Increased 24-Jun-2005 12:19 PM Page: 2469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/03ISR Number: 4194024-XReport Type:Direct Company Report #CTU 202191 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Olanzapine PS ORAL 10 MG QD ORAL Date:09/22/03ISR Number: 4194449-2Report Type:Direct Company Report #CTU 2020193 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Olanzapine PS ORAL 10 MG QD ORAL Date:09/22/03ISR Number: 4195892-8Report Type:Expedited (15-DaCompany Report #FRWYE297415SEP03 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Effexor (Venlafaxine Cyanosis Professional Hydrochloride, Tablet, 0) PS ORAL 300 MG DAILY, ORAL 1 WK Glyceryl Trinitrate (Glyceryl Trinitrate, Unspec, 0) SS Isoptin (Verapamil Hydrochloride, 0) SS ORAL ORAL Prozac (Fluoxetine Hydrochloride, 0) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL 5 MG DAILY ORAL Date:09/23/03ISR Number: 4191736-9Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12386470 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Failure Deprax Tabs PS Apothecon ORAL 30 tablets Hospitalization - Lexatin SS ORAL 30 capsules Initial or Prolonged Dormodor SS ORAL 30 capsules Vandral SS ORAL 60 tablets Zyprexa SS ORAL 28 tablets Date:09/23/03ISR Number: 4197814-2Report Type:Expedited (15-DaCompany Report #US_030997518 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Consumer Zyprexa-Oral Other Diabetes Mellitus (Olanzapine) Diabetic Ketoacidosis (Olanzapine) PS Haemoptysis Loss Of Consciousness Malaise Pulse Absent Pupil Fixed Respiratory Arrest 24-Jun-2005 12:19 PM Page: 2470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4195437-2Report Type:Direct Company Report #CTU 202393 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Haloperidol 5 Mg/1 Intervention to Syndrome Ml PS INTRAMUSCULAR 5 M Q8 H PRN Prevent Permanent IM Impairment/Damage Zyprexa 10 Mg Lilly SS Lilly ORAL 10 MG BID ORAL Geodon-Ziprasidone C Date:09/24/03ISR Number: 4197767-7Report Type:Expedited (15-DaCompany Report #HQWYE581909SEP03 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Vandral Retard Syndrome Professional (Venlafaxine Other Hydrochloride, Capsule, Extended Release) PS ORAL 300 MG 1X PER 1 DAY ORAL 9 DAY Sinemet (Carbidopa./Levodopa ) SS ORAL 3 DOSE 1X PER 1 DAY ORAL Zyprexa (Olanzapine) SS ORAL 20 MG 1X PER 1 DAY ORAL 9 DAY Idalprem (Lorazepam) C Rexer (Mirtazapine) C Date:09/24/03ISR Number: 4197771-9Report Type:Expedited (15-DaCompany Report #JP_030901695 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Gastritis Health (Olanzapine) PS 20 MG/DAY Hepatitis Professional Contomin Suicide Attempt Company (Chlorpromazine Representative Hydrochloride) C Other Impromen (Bromperidol) C Vegetamin B C Akineton (Biperiden Hydrochloride) C Brotizolam C Benzalin (Nitrazepam) C Rohypnol (Flunitrazepam) C Date:09/24/03ISR Number: 4197772-0Report Type:Expedited (15-DaCompany Report #JP_030801507 Age:73 YR Gender:Female I/FU:F Outcome PT Death Bronchial Obstruction Hospitalization - Constipation Initial or Prolonged Hypercapnia Respiratory Depression Respiratory Failure 24-Jun-2005 12:19 PM Page: 2471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sputum Retention Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) PS 2.5 MG/DAY Professional Wintermin Company (Chlorpromazine Representative Hydrochloride) C Other Gaster (Famotidine) C Gaster (Famotidine) C Primperan (Metoclopramide) C Bisolvon (Bromhexine Hydrochloride) C Ciproxan (Ciprofloxacin Hydrochloride) C Rohypnol (Flunitrazepam) C Serenace (Haloperidol) C Lasix (Furosemide) C Selbex (Teprenone) C Mucosolvan (Ambroxol Hydrochloride) C Date:09/24/03ISR Number: 4197774-4Report Type:Expedited (15-DaCompany Report #JP_030601208 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Zyprexa-Oral Hospitalization - Dystonia Health (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Extrapyramidal Disorder Professional Permax (Pergolide Hypokalaemia Company Mesylate) SS 750 UG/DAY On And Off Phenomenon Representative Symmetrel Psychiatric Symptom Other (Amantadine Pyrexia Hydrochloride) C Respiratory Arrest Levodopa Benserazide Soliloquy Hydrochlo C Suicidal Ideation Depromel Temperature Regulation (Fluvoxamine) C Disorder Thyradin S Vocal Cord Disorder (Levothyroxine Sodium) C Pantosin (Pantethine) C Magnesium Oxide C Date:09/24/03ISR Number: 4197776-8Report Type:Expedited (15-DaCompany Report #JP_030500916 Age:51 YR Gender:Male I/FU:F Outcome PT Death Abdominal Distension Alanine Aminotransferase Aspartate Aminotransferase Back Pain Blood Bilirubin Blood Lactate 24-Jun-2005 12:19 PM Page: 2472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydrogenase Decreased Appetite Gamma-Glutamyltransferase Hepatic Cancer Metastatic Report Source Product Role Manufacturer Route Dose Duration Hepatomegaly Foreign Zyprexa-Oral Respiratory Failure Health (Olanzapine) PS 15 MG/DAY Professional Tegretol Company (Carbamazepine) C Representative ..... C Other ..... C ...... C Date:09/24/03ISR Number: 4197777-XReport Type:Expedited (15-DaCompany Report #JP_030701227 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Cerebral Atrophy Health (Olanzapine) PS 20 MG/DAY Dizziness Professional Risperdal Fall Company (Risperidone) C Feeling Abnormal Representative Ganaton (Itopride Hypotension Other Hydrochloride) C Medication Error Cetilo C Risumic (Amezinium Metilsulfate) C Vegetamin A C Lendormin (Brotizolam) C Prusennid (Senna Leaf) C Yodel (Senna) C Date:09/24/03ISR Number: 4197779-3Report Type:Expedited (15-DaCompany Report #GBS030813579 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 17.5 MG Other Lower Respiratory Tract Professional Mirtazapine C Infection Other Chlordiazepoxide C Renal Impairment Date:09/24/03ISR Number: 4197788-4Report Type:Expedited (15-DaCompany Report #JP_030801654 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Chloride Decreased Foreign Zyprexa-Oral Blood Sodium Decreased Study (Olanzapine) Depressed Level Of Health (Olanzapine) PS 10 MG/DAY Consciousness Professional Lullan (Perospirone Water Intoxication Other Hydrochloride) C Depas (Etizolam) C Setous (Zotepine) C Benzalin (Nitrazepam) C Isomytal (Amobarbital) C Brovarin (Bromisoval) C 24-Jun-2005 12:19 PM Page: 2473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Picoben (Sodium Picosulfate) C Date:09/24/03ISR Number: 4197789-6Report Type:Expedited (15-DaCompany Report #JP_030801622 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Convulsion Health (Olanzapine) Gaze Palsy Professional (Olanzapine) PS 2.5 MG/1 AT Productive Cough Company BEDTIME Respiratory Depression Representative Other Date:09/24/03ISR Number: 4197790-2Report Type:Expedited (15-DaCompany Report #JP_030801624 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa-Oral Disability Coombs Direct Test Health (Olanzapine) Other Positive Professional (Olanzapine) PS 5 MG/DAY Disseminated Company Vancomycin-Iv Intravascular Coagulation Representative (Vancomycin) Dyspnoea Other (Vancomycin Lung Infection Hydrochlorid SS Pseudomonal Harnal (Tamsulosin Oxygen Saturation Hydrochloride) C Pneumonia Staphylococcal Biofermin C Respiratory Failure Sm Powder C Clarith (Clarithromycin) C Isodine Gargle (Iodine) C Fungizone (Amphotericin B) C Lendormin (Brotizolam) C Magnesium Oxide C Lactec C Methylprednisolone Sodium Succinate C Carbenin C Aminofluid C Glunon (Glucose) C Atarax (Hydroxyzine Hydrochloride) C Serenace (Haloperidol) C Solita -T3 Injection C Date:09/24/03ISR Number: 4197791-4Report Type:Expedited (15-DaCompany Report #JP_030801625 Age:60 YR Gender:Male I/FU:F Outcome PT Death Blood Lactate Life-Threatening Dehydrogenase Increased Disability Blood Pressure Decreased C-Reactive Protein 24-Jun-2005 12:19 PM Page: 2474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Cardiac Failure Cardio-Respiratory Arrest Coma Report Source Product Role Manufacturer Route Dose Duration Cough Foreign Zyprexa-Oral Cyanosis Health (Olanzapine) Delirium Professional (Olanzapine) PS 5 MG/1 AT Dyspnoea Company BEDTIME Dyspnoea Exertional Representative Predonine Fall Other (Prednisolone) C Heart Rate Decreased Gatifloxacin C Hypoxia Mucosta (Rebamipide) C Injury Asphyxiation Baktar C Mydriasis Silece Pallor (Flunitrazepam0 C Pneumonia Aspiration Myslee (Zolpidem Pneumothorax Tartrate) C White Blood Cell Count Increased Date:09/24/03ISR Number: 4197792-6Report Type:Expedited (15-DaCompany Report #JP_030801637 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa-Oral Cardio-Respiratory Arrest Health (Olanzapine) Chest Discomfort Professional (Olanzapine) PS 5 MG/DAY Cough Company Zyloric Depressed Level Of Representative (Allopurinol) C Consciousness Other Zantac(Ranitidine Dyspnoea Hydrochloride) C Dyspnoea Exertional Gasmotin (Mosapride Oedema Citrate) C Respiration Abnormal Monilac (Lactulose) C Digoxin C Nauzelin (Domperidone) C Topicain (Oxetacaine) C Dogmatyl (Sulpiride) C Myslee (Zolpidem Tartrate) C Nauzelin (Domperidone) C Voltaren (Diclofenac Sodium) C Aldactone-A (Spironolactone) C Depas (Etizolam) C Azunol (Sodium Gualenate) C Mucodyne (Carbocisteine) C Gatifloxacin C Tetramide (Mianserin Hydrochloride) C Benzalin (Nitrazepam) C Contomin (Chlorpromazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lactose C Aminofluid C Maxipime (Cefepime Hydrochloride) C Isepacin (Isepamicin Sulfate) C Dalacin-S (Clindamycin) C Lasix (Furosemide) C Date:09/24/03ISR Number: 4197808-7Report Type:Expedited (15-DaCompany Report #US_030997553 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Olanzapine-Oral Literature (Olanzapine) PS 5 MG/AY 44 DAY Health Melperone C Professional Acetylsalicylic Acid C Other Digoxin C Clomethiazole C Valproic Acid C Date:09/24/03ISR Number: 4197809-9Report Type:Expedited (15-DaCompany Report #JP_030901720 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Arrhythmia Professional (Olanzapine) PS 30 MG/DAY Aspartate Company Hirnamin Aminotransferase Representative (Levomepromazine) C Increased Other Flunitrazepam C Blood Creatine Isomytal Phosphokinase Increased (Amobarbital) C Blood Glucose Blood Potassium Increased Cardio-Respiratory Arrest Excitability Logorrhoea Prescribed Overdose Sudden Death Date:09/24/03ISR Number: 4197810-5Report Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Zyprexa-Oral Initial or Prolonged Pyrexia Health (Olanzapine) Renal Failure Acute Professional (Olanzapine) PS 10 MG/DAY Rhabdomyolysis Company Representative Other 24-Jun-2005 12:19 PM Page: 2476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4197815-4Report Type:Expedited (15-DaCompany Report #FR_030902854 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Other Haldol (Haloperidol) C Increased Tercian Blood Creatine (Cyamemazine) C Phosphokinase Increased Neuleptil Blood Lactate (Periciazine) C Dehydrogenase Increased Lepticur Disturbance In Attention (Tropatepine Electrocardiogram Qt Hydrochloride) C Prolonged Sulfarlem (Anethole Leukocytosis Trithione) C Liver Function Test Seglor Abnormal (Dihydroergotamine Neuroleptic Malignant Mesilate) C Syndrome Date:09/24/03ISR Number: 4198205-0Report Type:Expedited (15-DaCompany Report #CA_030906207 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Olanzapine-Oral Initial or Prolonged Haematuria Study (Olanzapine) PS 5 DSG Renal Colic Health FORM/DAY Professional Losec (Omeprazole) C Other Atenolol C Lisinopril C Hydrochlorothiazide C Date:09/24/03ISR Number: 4198240-2Report Type:Expedited (15-DaCompany Report #US_030997554 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Olanzapine-Oral Hospitalization - Depressed Level Of Literature (Olanzapine) PS 5 MG/DAY Initial or Prolonged Consciousness Health Tamoxifen C Other General Physical Health Professional Mirtazapine C Deterioration Other Oxazepam C Hypotension Eltilefrin C Oedema Peripheral Cyanocobalamin C Pulmonary Embolism Furosemide C Sinus Tachycardia Acetylcysteine C Tachypnoea Spironolactone C Lactulose C Date:09/24/03ISR Number: 4198244-XReport Type:Expedited (15-DaCompany Report #US_030997551 Age:89 YR Gender:Male I/FU:I Outcome PT Death Chronic Obstructive Hospitalization - Pulmonary Disease Initial or Prolonged Deep Vein Thrombosis Infected Skin Ulcer Oesophagitis 24-Jun-2005 12:19 PM Page: 2477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Embolism Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Literature (Olanzapine) PS 5 MG/DAY Health Venlafaxine C Professional Haloperidol C Other Hydroxyzine C Clomethiazole C Topical Corticosteroids C Date:09/24/03ISR Number: 4198259-1Report Type:Expedited (15-DaCompany Report #DE_030911980 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Zyprexa-Oral Initial or Prolonged Conversion Disorder Health (Olanzapine) Convulsion Professional (Olanzapine) PS 10 MG/DAY 6 WK Drug Level Increased Other Fevarin (Fluvoxamine Rhabdomyolysis Maleate) C Vomiting Date:09/24/03ISR Number: 4198263-3Report Type:Expedited (15-DaCompany Report #FR_030902879 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebellar Syndrome Foreign Zyprexa-Oral Health (Olanzapine) PS 10 MG/DAY Professional Other Date:09/24/03ISR Number: 4198265-7Report Type:Expedited (15-DaCompany Report #EWC030936201 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Foreign Zyprexa-Oral Initial or Prolonged Pancreatitis Health (Olanzapine) Sepsis Professional (Olanzapine) PS 2 YR Company Representative Other Date:09/24/03ISR Number: 4198269-4Report Type:Expedited (15-DaCompany Report #EWC030936169 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa-Oral Hospitalization - Syndrome Health (Olanzaipine) PS 10 MG/DAY Initial or Prolonged Paranoia Professional Benzodiazepine C Pyrexia Company Antiparkinson Drugs C Representative Other 24-Jun-2005 12:19 PM Page: 2478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4198270-0Report Type:Expedited (15-DaCompany Report #US_030997504 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Olanzapine-Oral Increased Literature (Olanzapine) PS 10 MG Blood Triglycerides Health Increased Professional Hepatic Steatosis Other Hepatomegaly Weight Increased Date:09/24/03ISR Number: 4198272-4Report Type:Expedited (15-DaCompany Report #US_030997501 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Olanzapine-Oral Increased Literature (Olanzapine) PS 10 MG Blood Triglycerides Health Flupentixol C Increased Professional Hepatic Steatosis Other Hepatomegaly Hyperlipidaemia Ultrasound Liver Abnormal Weight Increased Date:09/24/03ISR Number: 4199156-8Report Type:Expedited (15-DaCompany Report #USA-2003-0009569 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Oxycontin Cr PS MG Haemorrhage Professional Bupropion Pneumonia Other (Amfebutamone) SS MG Toxicologic Test Abnormal Olanzapine (Olanzapine) SS MG Venlafaxine (Venlafaxine) SS MG Date:09/24/03ISR Number: 4199166-0Report Type:Expedited (15-DaCompany Report #USA030946603 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa-Oral Overdose Professional (Olanzapine) PS Company Valium (Diazepam) C Representative Duragesic (Fentanyl) C Date:09/24/03ISR Number: 4199167-2Report Type:Expedited (15-DaCompany Report #USA030946381 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Zyprexa-Oral Initial or Prolonged Disease Recurrence Professional (Olanzapine) PS Company Representative 24-Jun-2005 12:19 PM Page: 2479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4199169-6Report Type:Expedited (15-DaCompany Report #USA030946396 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Operation Health Zyprexa-Oral Initial or Prolonged Thrombosis Professional (Olanzapine) PS Company Representative Date:09/24/03ISR Number: 4199170-2Report Type:Expedited (15-DaCompany Report #USA030946150 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Encephalopathy Health Zyprexa-Oral Parkinsonism Professional (Olanzapine) PS 15 MG Pyrexia Company Lithium C Representative Date:09/24/03ISR Number: 4199173-8Report Type:Expedited (15-DaCompany Report #USA030537782 Age:2 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Strattera Apnoea Health (Atomoxetine Bipolar Disorder Professional Hydrochloride PS 30 MG/DAY Convulsion Zyprexa-Oral Insomnia (Olanzapine) Psychomotor Hyperactivity (Olanzapine) SS 2.5 MG/2 DAY Respiratory Arrest Sedation Somnolence Date:09/24/03ISR Number: 4199267-7Report Type:Expedited (15-DaCompany Report #USA030433966 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prescribed Overdose Health Zyprexa-Oral Therapeutic Agent Professional (Olanzapine) Toxicity (Olanzapine) PS 35 MG/DAY Cogentin(Benzatropin e Mesilate) C Date:09/25/03ISR Number: 4196199-5Report Type:Direct Company Report #CTU 202553 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Zyprexa 20 Mg Eli Initial or Prolonged Living Impaired Lilly PS Eli Lilly ORAL 20 MG ONCE A Disability Dementia Alzheimer'S Type DAY ORAL Electroencephalogram Nph Insulin C Abnormal Zocor C Memory Impairment Coumadin C Personality Change Hyzaar C Sleep Apnoea Syndrome 24-Jun-2005 12:19 PM Page: 2480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/03ISR Number: 4196200-9Report Type:Direct Company Report #CTU 202554 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Celexa 10mg PS ORAL 10MG HS ORAL Hospitalization - Syndrome Zyprexa 10mg SS ORAL 10MG HS ORAL Initial or Prolonged Calcium W/ Vit D C Ranitidine C Multivitamin C Senna/Docusate C Miacalcin C Clonazepam C Date:09/26/03ISR Number: 4195457-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE03182 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Leponex / Clozaril Hospitalization - Syndrome (Clozapine) PS Novartis Sector: Initial or Prolonged Pneumonia Pharma ORAL Unknown Thrombocytopenia Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 750mg/day Zyprexa SS ORAL 20 mg/day 5760 MIN Nipolept "Aventis" SS ORAL 150 mg/day 2880 MIN Haldol "Janssen" C ORAL 15 mg/day 15840MIN Solian C ORAL 800mg/day 53280MIN Date:09/26/03ISR Number: 4197026-2Report Type:Direct Company Report #CTU 202655 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Olanzapine PS ORAL 15MG Q DAY Initial or Prolonged Diabetic Ketoacidosis ORAL Hypertriglyceridaemia Insulin C Pancreatitis Date:09/26/03ISR Number: 4197109-7Report Type:Direct Company Report #CTU 202722 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa 10 Mg Eli Required Insulin-Dependent Lilly PS Eli Lilly ORAL 10 MG PO QD 1 MON Intervention to Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4200160-1Report Type:Expedited (15-DaCompany Report #JP_030801507 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Ph Increased Foreign Zyprexa-Oral Hospitalization - Bronchial Obstruction Health (Olanzapine) Initial or Prolonged Coma Professional (Olanzapine) PS 2.5 MG/DAY Constipation Company Wintermin Cough Representative (Chlorpromazine Hypercapnia Other Hydrochloride) C Respiratory Failure Gaster (Famotidine) C 24-Jun-2005 12:19 PM Page: 2481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gaster (Famotidine) C Primperan (Metoclopramide) C Bisolvon (Bromhexine Hydrochloride) C Ciproxan (Ciprofloxacin Hydrochloride) C Rohypnol (Flunitrazepam) C Serenace (Haloperidol) C Lasix (Furosemide) C Selbex (Teprenone) C Mucosolvan (Ambroxol Hydrochloride) C Date:09/26/03ISR Number: 4210265-7Report Type:Periodic Company Report #1998UW47645 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Literature Seroquel PS ORAL 200 MG BID PO Intervention to Neutropenia Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Thrombocytopenia Professional PO Impairment/Damage Olanzapine SS 10 MG DAILY Risperdal C Date:09/26/03ISR Number: 4210311-0Report Type:Periodic Company Report #2003UW07518 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Consumer Seroquel PS Intervention to Convulsion Seroquel SS ORAL 300 MG HS PO Prevent Permanent Zyprexa SS Impairment/Damage Unspecified Medications C Date:09/26/03ISR Number: 4210893-9Report Type:Periodic Company Report #2002UW10893 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Olanzapine SS Prevent Permanent Impairment/Damage Date:09/29/03ISR Number: 4202851-5Report Type:Expedited (15-DaCompany Report #200304644 Age:48 YR Gender:Female I/FU:I Outcome PT Death Acute Respiratory Hospitalization - Distress Syndrome Initial or Prolonged Alanine Aminotransferase Required Increased Intervention to Analgesic Drug Level Prevent Permanent Increased Impairment/Damage Aspartate 24-Jun-2005 12:19 PM Page: 2482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Creatinine Increased Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Literature Unspecified Blood Urea Decreased Other Acetaminophen Bowel Sounds Abnormal Product PS ORAL PO Cardiac Arrest Cocaine SS Coma Caffeine SS ORAL PO Completed Suicide Citalopram SS ORAL PO Electrocardiogram Qrs Quetiapine SS ORAL PO Complex Shortened Clonidine SS ORAL PO Electrocardiogram T Wave Olanzapine SS ORAL PO Abnormal Nicotine SS Haemorrhage Pantoprazole SS ORAL PO Heart Rate Increased Clonazepam SS ORAL PO Intentional Misuse Aspirin SS International Normalised Levothyroxine SS ORAL PO Ratio Increased Metabolic Acidosis Multiple Drug Overdose Prothrombin Time Prolonged Urine Output Decreased Date:09/30/03ISR Number: 4202157-4Report Type:Expedited (15-DaCompany Report #FLUV00303001761 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akathisia Foreign Depromel 25 Other Blood Potassium Decreased Health (Fluvoxamine Condition Aggravated Professional Maleate) PS ORAL 50 MG DAILY Drug Interaction Other PO Drug Level Increased Zyprexa (Olanzapine) SS ORAL 2.5 MG DAILY Extrapyramidal Disorder PO On And Off Phenomenon Permax (Pergolide Pyrexia Mesilate) SS ORAL 750 MCG DAILY Respiratory Arrest PO Soliloquy Symmetrel Suicidal Ideation (Amantadine Temperature Regulation Hydrochloride) C Disorder Pantosin Thyroidectomy (Pantethine) C Vocal Cord Paresis Madopar (Levodopa/Benserazid e Hydrochloride) C Magnesium Oxide (Magnesium Oxide) C Thyradin S (Levothyroxine Sodium) C Aspara (Aspartate Potassium) C Date:09/30/03ISR Number: 4202895-3Report Type:Expedited (15-DaCompany Report #USA030638666 Age: Gender:Male I/FU:F Outcome PT Report Source Death Overdose Health Professional 24-Jun-2005 12:19 PM Page: 2483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 7.5 MG/DAY Celexa (Citalopram Hydrobromide) C Date:09/30/03ISR Number: 4203010-2Report Type:Expedited (15-DaCompany Report #US_030997665 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa-Oral\ Other Drug Level Increased (Olanzapine) Respiratory Arrest (Olanzapine) PS 7.5 MG Respiratory Failure Adderall C Ativan (Lorazepam) C Celexa (Citaloprma Hydrobromide) C Date:09/30/03ISR Number: 4203073-4Report Type:Expedited (15-DaCompany Report #USA030946664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atelectasis Consumer Zyprexa-Oral Chest Pain (Olanzapine) Pleural Effusion (Olanzapine) PS Date:09/30/03ISR Number: 4203150-8Report Type:Expedited (15-DaCompany Report #DE_030912041 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa-Oral Hospitalization - Syndrome Health (Olanzapine) Initial or Prolonged Pneumonia Professional (Olanzapine) PS 20 MG/DAY Other Nipolept (Zotepine) C Diazepam C Akinetoni (Biperiden Hydrochloride) C Date:09/30/03ISR Number: 4203168-5Report Type:Expedited (15-DaCompany Report #EWC011229464 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa-Oral Hospitalization - Blood Insulin Increased Literature (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Bundle Branch Block Right Health Rocefin (Ceftriaxone Cardiac Failure Professional Sodium) C Congestive Other Enapren (Enalapril Confusional State Maleate) C Hypoglycaemic Coma Lasix (Furosemide) C Myocardial Ischaemia Clexane Sinus Tachycardia (Heparin-Fraction, Sodium Salt) C Actrapid (Insulin) C Zantac (Ranitidine 24-Jun-2005 12:19 PM Page: 2484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:09/30/03ISR Number: 4203181-8Report Type:Expedited (15-DaCompany Report #JP_030901812 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 10 MG/DAY Professional Lexotan (Bromazepam) C Other Tetramide (Mianserin Hydrochloride) C Halcion (Triazolam) C Amoxan (Amoxapine) C Date:09/30/03ISR Number: 4203198-3Report Type:Expedited (15-DaCompany Report #US_030997614 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Olanzapine-Oral Psoriasis Literature (Olanzapine) PS 5 MG/2 DAY Therapy Non-Responder Health Professional Date:09/30/03ISR Number: 4203384-2Report Type:Expedited (15-DaCompany Report #EWC030936250 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Olanzapine-Oral Anti-Hbc Antibody Health (Olanzapine) PS 20 MG/DAY Positive Professional Blood Lactate Other Dehydrogenase Increased Cryoglobulins Present Elliptocytosis Erythroleukaemia Haptoglobin Decreased Leukaemia Red Blood Cell Spherocytes Present Thrombocytopenia Date:09/30/03ISR Number: 4203386-6Report Type:Expedited (15-DaCompany Report #EWC030936258 Age:52 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Anaemia Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Feeling Abnormal Gamma-Glutamyltransferase 24-Jun-2005 12:19 PM Page: 2485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Hepatic Steatosis Hepatitis Jaundice Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Effexor (Venlafaxine Other Hydrochloride) C Tranxilium (Clorazepate Dipotassium) C Imovane (Zopiclone) C Date:09/30/03ISR Number: 4203392-1Report Type:Expedited (15-DaCompany Report #EWC030936271 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG/DAY 6 WK Professional Risperidone C Company Paracetamol C Representative Other Date:09/30/03ISR Number: 4203395-7Report Type:Expedited (15-DaCompany Report #GBS030913711 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Olanzapine-Oral Heart Injury Health (Olanzapine) PS 20 MG Professional Haloperidol C Company Representative Other Date:09/30/03ISR Number: 4203397-0Report Type:Expedited (15-DaCompany Report #GBS030913717 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hallucination Foreign Zyprexa-Oral Hospitalization - Neuroleptic Malignant Health (Olanzapine) PS 15 MG/DAY Initial or Prolonged Syndrome Professional Fluoxetine-Oral Other (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG Bendrofluazide C Diclofenac C Zopiclone C Date:09/30/03ISR Number: 4203416-1Report Type:Expedited (15-DaCompany Report #FR_030101930 Age:35 YR Gender:Female I/FU:F Outcome PT Hospitalization - Caesarean Section Initial or Prolonged Complications Of Maternal Exposure To Therapeutic Drugs Pre-Eclampsia 24-Jun-2005 12:19 PM Page: 2486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premature Baby Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) PS 5 MG/DAY Professional Other Date:09/30/03ISR Number: 4203418-5Report Type:Expedited (15-DaCompany Report #FR_030902854 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) PS 20 MG/DAY Aspartate Professional Haldol (Haloperidol) C Aminotransferase Other Tercian Increased (Cyamemazine) C Blood Creatine Neuletpil Phosphokinase Increased (Periciazine) C Blood Creatinine Lepticur Increased (Tropatepine Blood Culture Positive Hydrochloride) C Blood Lactate Sulfarlem (Anethole Dehydrogenase Increased Trithione) C Blood Urea Seglor C-Reactive Protein (Dihydroergotamine Dehydration Mesilate) C Electrocardiogram Qt Prolonged Neuroleptic Malignant Syndrome Streptococcal Infection Troponin Date:09/30/03ISR Number: 4203426-4Report Type:Expedited (15-DaCompany Report #JP_030801622 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Convulsion Health (Olanzapine) PS 2.5 MG/1 AT Death Professional BEDTIME Productive Cough Company Teicoplanin C Representative Lasix (Furosemide) C Other Total Parenteral Nutrition C Date:09/30/03ISR Number: 4203472-0Report Type:Expedited (15-DaCompany Report #JP_030801624 Age:73 YR Gender:Male I/FU:F Outcome PT Death Condition Aggravated Life-Threatening Depressed Level Of Other Consciousness Disseminated Intravascular Coagulation Heart Rate Decreased Lung Infection Pseudomonal 24-Jun-2005 12:19 PM Page: 2487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Staphylococcal Refusal Of Treatment By Patient Report Source Product Role Manufacturer Route Dose Duration Respiratory Failure Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5MG/DAY Company Vancomycin-Iv Representative (Vancomycin) Other (Vancomycin Hydrochloride) SS Harnal Tamsulosin Hydrochloride) C Biofermin C Sm Powder C Clarith (Clarithromycin) C Isodine Gargle (Iodine) C Fungizone (Amphotericin B) C Lendormin (Brotizolam) C Magnexsium Oxide C Lactec C Methylprednisolone Sodium Succinate C Carbenin C Aminofluid C Glunon (Glucose) C Atarax (Hydroxyzine Hydrochloride) C Serrenace (Haloperidol) C Solita-T3 Injection C Date:09/30/03ISR Number: 4203478-1Report Type:Expedited (15-DaCompany Report #JP_030801625 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Lactate Foreign Zyprexa-Oral Life-Threatening Dehydrogenase Increased Health (Olanzapine) Blood Pressure Decreased Professional (Olanzapine) PS 5 MG/1 AT Cardiac Failure Company BETIME Cardio-Respiratory Arrest Representative Predonine Choking Other (Prednisolone) C Coma Gatifloxacin C Fall Mucosta(Rebamipide) C Heart Rate Decreased Baktar C Interstitial Lung Disease Silece Mydriasis (Flunitrazepam) C Pallor Myslee (Zolpidem Pneumothorax Tartrate) C Date:09/30/03ISR Number: 4203706-2Report Type:Expedited (15-DaCompany Report #EWC030835871 Age:35 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 2488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Zyprexa-Oral Constipation Health (Olanzapine) Ileus Paralytic Professional (Olanzapine) PS 80 MG/DAY Pneumonia Company Cisordinol Postoperative Infection Representative (Clopenthixol Psychiatric Symptom Other Hydrochloride) C Psychopax(Diazepam) C Lithium Carbonate C Bellanorm(Belladonna Alkaloids) C Date:09/30/03ISR Number: 4203786-4Report Type:Expedited (15-DaCompany Report #JP_030801629 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa - Oral Hospitalization - Aspartate Health (Olanzapine) Initial or Prolonged Aminotransferase Professional (Olanzapine) PS 270 MG/DAY Blood Bilirubin Company Serenace Blood Lactate Representative (Haloperidol) C Dehydrogenase Lodopin (Zotepine) C Depressed Level Of Hirnamin (Zolpidem Consciousness Tartrate) C Gamma-Glutamyltransferase Myslee (Zolpidem Heart Rate Decreased Tartrate) C Hepatic Function Abnormal Lung Disorder Overdose Pneumonia Aspiration Po2 Decreased Suicide Attempt Date:09/30/03ISR Number: 4203808-0Report Type:Expedited (15-DaCompany Report #DE_030912019 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Zyprexa Velotab-Oral Hospitalization - Bone Marrow Depression Health (Olanzapine) Initial or Prolonged Drug Toxicity Professional (Olanzapine) PS 20 MG/DAY Leukopenia Company Carbamazepine C Thrombocytopenia Representative Kreon (Pancreatin) C Other Pantozol (Pantoprazole Sodium) C Konakion (Phytomenadione) C Acetylcysteine C Neurocil (Levomepromazine Maleate) C Antibiotics C 24-Jun-2005 12:19 PM Page: 2489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/03ISR Number: 4203934-6Report Type:Expedited (15-DaCompany Report #JP_021200300 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniotic Cavity Infection Foreign Zyprexa-Oral Initial or Prolonged Anxiety Health (Olanzapine) PS Complications Of Maternal Professional Wypax (Lorazepam) C Exposure To Therapeutic Company Drugs Representative Pregnancy Other Premature Rupture Of Membranes Date:09/30/03ISR Number: 4203935-8Report Type:Expedited (15-DaCompany Report #JP_030901726 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Foreign Zyprexa PS 10 MG/DAY Initial or Prolonged Health Serenace Disability Professional (Haloperidol) C Company Depas (Etizolam) C Representative Artane Other (Trihexyphenidyl Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Pursennide (Senna Leaf) C Date:09/30/03ISR Number: 4203937-1Report Type:Expedited (15-DaCompany Report #JP_030901799 Age:2 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniotic Cavity Infection Foreign Zyprexa PS TRANSPLACENTAL Initial or Prolonged Maternal Drugs Affecting Health Wypax (Lorazepam) C Foetus Professional Premature Rupture Of Company Membranes Representative Tachypnoea Other Umbilical Hernia Date:09/30/03ISR Number: 4203939-5Report Type:Expedited (15-DaCompany Report #JP_030901826 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa Intentional Self-Injury Health (Olanzapine) PS 5 MG/DAY Professional Valerin (Valproate Company Sodium) C Representative Depas (Etizolam) C Other Luvox (Fluvoxamine Maleate) C Silece (Flunitrazepam) C 24-Jun-2005 12:19 PM Page: 2490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/03ISR Number: 4204122-XReport Type:Expedited (15-DaCompany Report #USA030946924 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Myocardial Infarction Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 20 MG 9 MON Representative Date:09/30/03ISR Number: 4204127-9Report Type:Expedited (15-DaCompany Report #USA030947076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ankle Fracture Consumer Zyprexa-Oral Brain Damage (Olanzapine) Fall (Olanzapine) PS Date:10/01/03ISR Number: 4204579-4Report Type:Expedited (15-DaCompany Report #JP_030901779 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diet Refusal Foreign Zyprexa-Oral Initial or Prolonged Refusal Of Treatment By Study (Olanzapine) Patient Health (Olanzapine) PS 2.5 MG/1 DAY Professional Dogmatyl (Sulpiride) C Other Solanax (Alprazolam) C Novamin (Prochlorperazine) C Horizon (Diazepam) C Date:10/02/03ISR Number: 4200865-2Report Type:Direct Company Report #CTU 202999 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Olanzapine PS Initial or Prolonged Gait Disturbance Required Intervention to Prevent Permanent Impairment/Damage Date:10/02/03ISR Number: 4200908-6Report Type:Direct Company Report #CTU 202998 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Olanzapine PS Initial or Prolonged Risperidone C Required Trazodone C Intervention to Hydrixyzine Hcl C Prevent Permanent Benztropine Mesylate C Impairment/Damage 24-Jun-2005 12:19 PM Page: 2491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/03ISR Number: 4203974-7Report Type:Expedited (15-DaCompany Report #DSA_23352_2003 Age:95 YR Gender:Female I/FU:U Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Enalapril Maleate PS ORAL 5MG QD PO Initial or Prolonged Blood Insulin Increased Literature Olanzapine SS ORAL 2.5 MG Q DAY Drug Interaction Health PO Hypoglycaemia Professional Furosemide C Hypoglycaemic Coma Other Enoxaparin Sodium C Insulin C-Peptide Amino Acids C Increased Ceftriaxone C 5% Glucose Solutiontassium Chloride C Potassium Chloride C Human Insulin C Ranitidine C Date:10/03/03ISR Number: 4201750-2Report Type:Direct Company Report #CTU 203104 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Potassium Increased Zyprexa 10mg PS ORAL 10 MG AT Hospitalization - Blood Sodium Decreased BEDTIM ORAL Initial or Prolonged Confusional State Depakote C Required Dehydration Lithium Carbonate C Intervention to Diabetes Mellitus Ambien C Prevent Permanent Inadequate Control Impairment/Damage Disorientation Loss Of Consciousness Weight Decreased Date:10/03/03ISR Number: 4204603-9Report Type:Expedited (15-DaCompany Report #2003039897 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Doxepin Completed Suicide Health (Doxepin) PS Professional Gabapentin (Gabapentin) SS Olanzapine (Olanzapine) SS Date:10/03/03ISR Number: 4205805-8Report Type:Expedited (15-DaCompany Report #2003040439 Age:67 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Confusional State Dehydration Dialysis Insomnia Neuroleptic Malignant Syndrome Pyrexia Renal Failure Acute Restlessness Stupor 24-Jun-2005 12:19 PM Page: 2492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Lustral (Sertraline) PS ORAL 100 MG Health (DAILY), ORAL Professional Haloperidol (Haloperidol) SS INTRAMUSCULAR 5 MG, INTRAMUSCULAR Olanzapine (Olanzapine) SS ORAL 10 MG (ONE DOSE), ORAL Date:10/03/03ISR Number: 4206348-8Report Type:Expedited (15-DaCompany Report #2003039720 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Gabapentin Other Completed Suicide Health (Gabapentin) PS Overdose Professional Methadone (Methadone) SS Olanzapine (Olanzapine) SS Date:10/03/03ISR Number: 4206349-XReport Type:Expedited (15-DaCompany Report #2003039951 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Sertraline Other Completed Suicide Health (Sertraline) PS ORAL ORAL Professional Alprazolam (Alprazolam) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Date:10/06/03ISR Number: 4204971-8Report Type:Expedited (15-DaCompany Report #2003040180 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Nardil (Phenelzine Initial or Prolonged Blood Glucose Sulfate) PS ORAL 30 MG Disability Difficulty In Walking (DAILY), ORAL Other Glucose Tolerance Olanzapine Impaired (Olanzapine) SS ORAL ORAL Impaired Work Ability Clonazepam Muscle Rigidity (Clonazepam) SS Muscle Spasms Rosiglitazone Muscle Strain Maleate Muscle Tightness (Rosiglitazone Myalgia Maleate) C Myocardial Infarction Tamsulosin Hydrochloride (Tamsulosin Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/03ISR Number: 4204998-6Report Type:Expedited (15-DaCompany Report #2003039950 Age:31 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Health (Ziprasidone) PS Professional Olanzapine (Olanzapine) SS Acetylsalicylic Acid (Acetylsalicylic Acid) SS Date:10/06/03ISR Number: 4205005-1Report Type:Expedited (15-DaCompany Report #2003039919 Age:54 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Sertraline Other Completed Suicide Health (Sertraline) PS ORAL ORAL Professional Olanzapine (Olanzapine) SS ORAL ORAL Clonazepam (Clonazepam) SS ORAL ORAL All Other Therapeutic Products SS ORAL ORAL Date:10/06/03ISR Number: 4205605-9Report Type:Expedited (15-DaCompany Report #2003039664 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amlodipine Health (Amlodipine) PS ORAL ORAL Professional Olanzapine (Olanzapine) SS ORAL ORAL Citalopram (Citalopram) SS ORAL ORAL All Other Therapeutic Products SS ORAL ORAL Date:10/07/03ISR Number: 4202465-7Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12392148 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Fungizone Os PS Apothecon ORAL 3 DAY Initial or Prolonged Phosphokinase Increased Zyprexa SS ORAL 10 mg daily Neuroleptic Malignant to Syndrome 24-May-2003 Tercian C ORAL Smecta C Daflon C Deroxat C Imovane C Orap C 4 mg 25-Apr-2003 to 11-May-2003 and 2 mg from Lepticur C Mopral C Vitamin B1 C 24-Jun-2005 12:19 PM Page: 2494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seresta C Effexor C Theralene C Clamoxyl C 5 DAY Date:10/07/03ISR Number: 4206827-3Report Type:Expedited (15-DaCompany Report #2003178974US Age:44 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Sertraline Completed Suicide Health (Sertraline Overdose Professional Hydrochloride) Respiratory Arrest Capsule PS ORAL ORAL Xanax (Alprazolam) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Date:10/07/03ISR Number: 4206903-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030905920 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Haloperidol Initial or Prolonged Drug Interaction Health (Haloperidol) Neuroleptic Malignant Professional Injection PS INTRAMUSCULAR 5 MG, 1 IN 1 Syndrome DAY, Renal Failure Acute INTRA-MUSCULA R Olanzapine (Olanzapine) Unknown SS 10 MG, 1 IN 1 DAY Sertraline (Sertraline) Unknown SS SEE IMAGE Date:10/07/03ISR Number: 4207086-8Report Type:Expedited (15-DaCompany Report #03P-163-0235135-00 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Valproic Acid Initial or Prolonged Insulin-Dependent Literature (Depakene) (Valproic Ketoacidosis Health Acid) (Valproic Professional Acid) PS 1 IN 1 D Olanzapine SS 5 MG, AT BEDTIME Venlafaxine SS 1 IN 1 D Date:10/08/03ISR Number: 4207492-1Report Type:Expedited (15-DaCompany Report #CA_030906263 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS Overdose Health Professional Other 24-Jun-2005 12:19 PM Page: 2495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4207503-3Report Type:Expedited (15-DaCompany Report #CA_030906250 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS Overdose Health Paroxetine C Professional Chlordiazepoxide C Demoxepam C Diazepam "Nordic" C Flurazepam C Date:10/08/03ISR Number: 4207504-5Report Type:Expedited (15-DaCompany Report #CA_030906251 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS Overdose Health Codeine C Professional Acetaminophen C Other Carbamazepine C Date:10/08/03ISR Number: 4207505-7Report Type:Expedited (15-DaCompany Report #CA_030906252 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Olanzapine-Oral Overdose Literature (Olanzapine) PS Health Codeine C Professional Acetaminophen C Other Date:10/08/03ISR Number: 4207506-9Report Type:Expedited (15-DaCompany Report #CA_030906253 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS Overdose Health Professional Other Date:10/08/03ISR Number: 4207507-0Report Type:Expedited (15-DaCompany Report #CA_030906254 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS ORAL ORAL Overdose Health Professional Other 24-Jun-2005 12:19 PM Page: 2496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4207508-2Report Type:Expedited (15-DaCompany Report #EWC030936368 Age:2 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Maternal Drugs Affecting Foreign Zyprexa-Oral Foetus Health (Olanzapine) Premature Baby Professional (Olanzapine) PS 25 WK Other Date:10/08/03ISR Number: 4207589-6Report Type:Expedited (15-DaCompany Report #USA030948028 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Consumer Zyprexa-Oral Initial or Prolonged Feeling Abnormal (Olanzapine) Incontinence (Olanzapine) PS UNKNOWN UNK Pyrexia Busar (Buspirone Hydrochloride) C Date:10/08/03ISR Number: 4207590-2Report Type:Expedited (15-DaCompany Report #US_030997777 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Hypersomnia Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Lithium C Date:10/08/03ISR Number: 4207591-4Report Type:Expedited (15-DaCompany Report #USA030948147 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Zyprexa-Oral Food Interaction Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 45 MG/AT Representative BEDTIME 6 YR Date:10/08/03ISR Number: 4207592-6Report Type:Expedited (15-DaCompany Report #US_030997819 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Anxiety Professional (Olanzapine) Depression Other (Olanzapine) PS 5 MG/AT Hallucination, Auditory BEDTIME Initial Insomnia Metadate Er Nightmare (Methylphenidate) C Psychotic Disorder Paxil Cr C Self Mutilation Concerta Treatment Noncompliance (Methylphenidate Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4207658-0Report Type:Expedited (15-DaCompany Report #USA030537782 Age:2 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Consumer Strattera Respiratory Arrest Health (Atomoxetine Sedation Professional Hydrochloride) PS 30 MG/DAY Somnolence Zyprexa-Oral Olanzapine) (Olanzapine) SS 2.5 MG/2 DAY Date:10/08/03ISR Number: 4207677-4Report Type:Expedited (15-DaCompany Report #2003035058 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zithromax (Caps) Initial or Prolonged Blood Glucose Increased (Azithromycin) PS ORAL (DAILY), ORAL Disability Candidiasis Carbamazepine Other Chills (Carbamazepine) SS ORAL ORAL Decreased Appetite Olanzapine Depression (Olanzapine) SS ORAL ORAL Dermatitis Exfoliative Venlafaxine Ear Pain Hydrochloride Herpes Virus Infection (Venlafaxine Hypersensitivity Hydrochloride) C Insomnia Leukocytoclastic Vasculitis Malaise Oedema Peripheral Otorrhoea Pain Pain In Extremity Pharyngolaryngeal Pain Photosensitivity Reaction Psychosomatic Disease Purulent Discharge Pyrexia Rash Refusal Of Treatment By Patient Rhinitis Allergic Scar Skin Exfoliation Skin Tightness Stevens-Johnson Syndrome Swelling Tension Headache Tinea Cruris Toxic Epidermal Necrolysis Upper Gastrointestinal Haemorrhage Upper Respiratory Tract Infection Urticaria Vision Blurred Weight Decreased 24-Jun-2005 12:19 PM Page: 2498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4207684-1Report Type:Expedited (15-DaCompany Report #EWC030936317 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Fluoxetine-Oral Initial or Prolonged Increased Health (Fluoxetine) Coma Professional (Fluoxetine Drug Interaction Other Hydrochlor PS 40 MG/DAY Drug Toxicity Olanzapine-Oral Heart Rate Increased (Olanzapine) SS 10 MG/DAY Pneumonia Methadone C Respiratory Failure Valproic Acid C Toxicologic Test Abnormal Amitriptyline C Zolpidem C Chlorprothixene C Date:10/08/03ISR Number: 4207753-6Report Type:Expedited (15-DaCompany Report #US_030897211 Age:13 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Atrial Septal Defect Consumer Zyprexa-Oral Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS Ventricular Septal Defect Date:10/08/03ISR Number: 4207789-5Report Type:Expedited (15-DaCompany Report #CA_030906261 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Olanzapine-Oral Alcohol Use Literature (Olanzapine) PS Drug Toxicity Health Lorazepam C Professional Ethanol C Other Date:10/08/03ISR Number: 4207824-4Report Type:Expedited (15-DaCompany Report #USA030843708 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Consumer Zyprexa-Oral Hospitalization - Muscle Rigidity (Olanzapine) Initial or Prolonged Parkinson'S Disease (Olanzapine) PS ORAL 5 MG/DAY, Renal Failure ORAL Salivary Hypersecretion Somnolence Date:10/08/03ISR Number: 4207826-8Report Type:Expedited (15-DaCompany Report #USA030947631 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa-Oral Other Completed Suicide Health (Olanzapine) Drug Toxicity Professional (Olanzapine) PS 20 MG/AT Intentional Misuse Company BEDTIME Pulmonary Embolism Representative Pulmonary Haemorrhage 24-Jun-2005 12:19 PM Page: 2499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4207859-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906368 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Concerta Initial or Prolonged Anxiety Professional (Methylphenidate Other Blood Glucose Hydrochloride) S R PS 72 MG, IN 1 Blood Thyroid Stimulating DAY Hormone Zyprexa (Olanzapine) SS 5 MG, 1 IN 1 Depression DAY Excoriation Paxil Cr (Paroxetine Haematocrit Hydrochloride) SS 12.5 MG, 1 IN Haemoglobin 1 DAY Hallucination, Auditory Metadate Er Initial Insomnia (Methylphenidate) SS 20 MG, 1 IN 1 Laceration DAY Nightmare Platelet Count Increased Psychotic Disorder Red Blood Cell Count Refusal Of Treatment By Relative Self Mutilation White Blood Cell Count Date:10/08/03ISR Number: 4208003-7Report Type:Expedited (15-DaCompany Report #US_030997763 Age:21 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Olanzapine-Oral Overdose Literature (Olanzapine) PS ORAL Health Professional Other Date:10/08/03ISR Number: 4208014-1Report Type:Expedited (15-DaCompany Report #US_030997764 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Olanzapine Other Phosphokinase Increased Literature Cerebral Haemorrhage Health (Olanzapine) PS ORAL Drug Toxicity Professional Hyperglycaemia Other Hyperpyrexia Hypokalaemia Hypotension Intentional Misuse Date:10/08/03ISR Number: 4208017-7Report Type:Expedited (15-DaCompany Report #US_030997774 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Olanzapine Other Haemorrhage Literature (Olanzapine) PS ORAL 10 MG/2 DAY Hyperpyrexia Health Paroxetine C Hypotension Professional Other 24-Jun-2005 12:19 PM Page: 2500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208019-0Report Type:Expedited (15-DaCompany Report #US_030997752 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS Overdose Health Paroxetine C Professional Date:10/08/03ISR Number: 4208022-0Report Type:Expedited (15-DaCompany Report #US_030997754 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS Overdose Health Professional Date:10/08/03ISR Number: 4208023-2Report Type:Expedited (15-DaCompany Report #US_030997759 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Olanzapine-Oral Overdose Literature (Olanzapine) PS Health Lithium C Professional Other Date:10/08/03ISR Number: 4208024-4Report Type:Expedited (15-DaCompany Report #US_030997761 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Olanzapine-Oral Overdose Literature (Olanzapine) PS 70 MG/DAY Health Clonazepam C Professional Other Date:10/08/03ISR Number: 4208034-7Report Type:Expedited (15-DaCompany Report #EWC030635231 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Bilirubin Increased Foreign Zyprexa Hospitalization - Blood Creatinine Health Initial or Prolonged Increased Professional (Olanzapine) PS ORAL 10 MG Blood Glucose Increased Company Prozac (Fluoxetine Blood Sodium Increased Representative Hydrochloride) C General Physical Health Other Edronax (Reboxetine) C Deterioration Fluzepam (Flurazepam Neuroleptic Malignant Hydrochloride) C Syndrome Apaurin (Diazepam) C Pneumonia Viral White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208036-0Report Type:Expedited (15-DaCompany Report #DE_030911952 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cleft Lip Foreign Zyprexa PS TRANSPLACENTAL 5 MG/2 DAY Other Hypoglycaemia Neonatal Health Seroquel Maternal Drugs Affecting Professional (Quetiapine Foetus Other Fumarate) C Date:10/08/03ISR Number: 4208055-4Report Type:Expedited (15-DaCompany Report #GBS030913717 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Zyprexa-Oral Hospitalization - Syndrome Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 15 MG/DAY Other Fluoxetine-Oral (Fluoxetine ) (Fluoxetine Hydrochlor SS 20 MG Bendrofluazide C Diclofenac C Zopiclone C Date:10/08/03ISR Number: 4208056-6Report Type:Expedited (15-DaCompany Report #JP_021200300 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniotic Cavity Infection Foreign Zyprexa-Oral Initial or Prolonged Anxiety Health (Olanzapine) Complications Of Maternal Professional (Olanzapine) PS Exposure To Therapeutic Company Drugs Representative Premature Rupture Of Other Membranes Date:10/08/03ISR Number: 4208057-8Report Type:Expedited (15-DaCompany Report #JP_030300503 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Drug Ineffective Health (Olanzapine) Hyperammonaemia Professional (Olanzapine) PS 20 MG/DAY Mood Altered Company Levotomin Representative (Levomepromazine Other Maleate) C Valerin (Valproate Sodium) C Thyradin S (Levothyroxine Sodium) C Pursennid (Senna Leaf) C Bromperidol C 24-Jun-2005 12:19 PM Page: 2502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208058-XReport Type:Expedited (15-DaCompany Report #JP_030300513 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Foreign Zyprexa-Oral Initial or Prolonged Blood Glucose Health (Olanzapine) Other Blood Sodium Professional (Olanzapine) PS 10 MG/DAY Grand Mal Convulsion Company Valerin (Valproate Hyperammonaemia Representative Sodium) C Irritability Other Pursennid (Senna Social Avoidant Behaviour Leaf) C Magnesium Oxide C Risperidone C Date:10/08/03ISR Number: 4208059-1Report Type:Expedited (15-DaCompany Report #JP_030801579 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Aspartate Professional (Olanzapine) PS 20 MG/DAY Other Aminotransferase Company Valerin (Valproate Increased Representative Sodium) C Blood Alkaline Other Rohypnol Phosphatase Increased (Flunitrazepam) C Blood Bilirubin Increased Pursennid (Senna Blood Creatine Leaf) C Phosphokinase Increased Magnesium Oxide C Blood Lactate Gasmotin (Mosapride Dehydrogenase Increased Citrate) C Blood Pressure Decreased Seroquel (Quetiapine Blood Urea Increased Fumarate) C Face Oedema Gamma-Glutamyltransferase Increased General Physical Health Deterioration Hypoglycaemia Jaundice Liver Disorder Malnutrition Oedema Peripheral Protein Total Decreased Pyrexia White Blood Cell Count Decreased Date:10/08/03ISR Number: 4208060-8Report Type:Expedited (15-DaCompany Report #CA_030906260 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Olanzapine-Oral Overdose Literature (Olanzapine) PS Health Valproic Acid C Professional Other 24-Jun-2005 12:19 PM Page: 2503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208061-XReport Type:Expedited (15-DaCompany Report #JP_030801622 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Productive Cough Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/1 AT Company BEDTIME Representative Teicoplanin C Other Lasix (Furosemide) C Total Parenteral Nutrition C Date:10/08/03ISR Number: 4208062-1Report Type:Expedited (15-DaCompany Report #JP_030801625 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa-Oral Life-Threatening Alveolar Proteinosis Health (Olanzapine) Blood Lactate Professional (Olanzapine) PS 5 MG/1 AT Dehydrogenase Increased Company BEDTIME Blood Pressure Decreased Representative Predonine Cardiac Failure Other (Prednisolone) C Cardio-Respiratory Arrest Gatifloxacin C Coma Mucosta (Rebamipide) C Cough Baktar C Cyanosis Silece Delirium (Flunitrazepam) C Depressed Level Of Myslee (Zolpidem Consciousness Tartrate) C Dyspnoea Dyspnoea Exertional Fall Heart Rate Decreased Hypoxia Injury Asphyxiation Insomnia Interstitial Lung Disease Mydriasis Pallor Pneumonia Aspiration Pneumothorax Pulmonary Fibrosis Respiratory Arrest Respiratory Depression White Blood Cell Count Increased Date:10/08/03ISR Number: 4208122-5Report Type:Expedited (15-DaCompany Report #JP_030801624 Age:73 YR Gender:Male I/FU:F Outcome PT Death C-Reactive Protein Life-Threatening Increased Other Collapse Of Lung Coma Condition Aggravated Depressed Level Of Consciousness Disseminated 24-Jun-2005 12:19 PM Page: 2504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intravascular Coagulation Dyspnoea Exertional Heart Rate Decreased Lung Infection Report Source Product Role Manufacturer Route Dose Duration Pseudomonal Foreign Zyprexa-Oral Pneumonia Staphylococcal Health (Olanzapine) ( Respiratory Failure Professional Olanzapine) PS 5 MG/DAY Company Vancomycin-Iv Representative (Vancomycin) Other (Vancomycin Hydrochloride) SS Harnal (Tamsulosin Hydrochloride) C Biofermin C Sm Powder C Clarith (Clarithromycin) C Isodine Gargle (Iodine) C Fungizone (Amphotericin B) C Lendormin (Brotizolam) C Magnesium Oxide C Lactec C Methylpresnisolone Sodium Succinate C Carbenin C Aminofluid C Glunon (Glucose) C Atarax (Hydroxyzine Hydrochloride) C Serenace (Haloperidol) C Solita-T3 Injection C Date:10/08/03ISR Number: 4208123-7Report Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Zyprexa-Oral Initial or Prolonged Pyrexia Health (Olanzapine) Renal Failure Acute Professional (Olanzapine) PS 10 MG/DAY Rhabdomyolysis Company Representative Other Date:10/08/03ISR Number: 4208125-0Report Type:Expedited (15-DaCompany Report #JP_030901826 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Valerin (Valproate Representative Sodium) C Other Depas (Etizolam) C Luvox (Fluvoxamine Maleate) C Silece C 24-Jun-2005 12:19 PM Page: 2505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208128-6Report Type:Expedited (15-DaCompany Report #EWC030835805 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cerebral Haemorrhage Foreign Zyprexa-Oral Coma Study (Olanzapine) Road Traffic Accident Health (Olanzapine) PS 10 MG/DAY Professional Eurodin (Estazolam) C Other Date:10/08/03ISR Number: 4208129-8Report Type:Expedited (15-DaCompany Report #CA_000901937 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Zyprexa-Oral Drug Toxicity Literature (Olanzapine) Health (Olanzapine) PS Professional Fluoxetine-Oral Company (Fluoxetine) Representative (Fluoxetine Other Hydrochlor SS Bupropion Hydrochloride C Lorazepam C Haldol (Haloperidol) C Date:10/08/03ISR Number: 4208130-4Report Type:Expedited (15-DaCompany Report #CA_980600053 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Drug Toxicity Health (Olanzapine) Overdose Professional (Olanzapine) PS Other Date:10/08/03ISR Number: 4208133-XReport Type:Expedited (15-DaCompany Report #CA_010103064 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Drug Level Above Literature (Olanzapine) Therapeutic Health (Olanzapine) PS 800 MG Drug Toxicity Professional Intentional Misuse Company Treatment Noncompliance Representative Other Date:10/08/03ISR Number: 4208135-3Report Type:Expedited (15-DaCompany Report #JP_030901779 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diet Refusal Foreign Zyprexa-Oral Initial or Prolonged Refusal Of Treatment By Study (Olanzapine) Patient Health (Olanzapine) PS 2.5 MG/ 1 DAY Professional Dogmatil (Sulpiride) C Other Solanax (Alprazolam) C Noavmin (Prochlorperazine) C 24-Jun-2005 12:19 PM Page: 2506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Horizon (Diazepam) C Date:10/08/03ISR Number: 4208208-5Report Type:Expedited (15-DaCompany Report #EWC030936364 Age:6 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Neonatal Foreign Zyprexa-Oral Maternal Drugs Affecting Health (Olanzapine) Foetus Professional (Olanzapine) PS 25 WK Premature Baby Other Date:10/08/03ISR Number: 4208210-3Report Type:Expedited (15-DaCompany Report #JP_030901692 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Company Toledomin Increased Representative (Milnacipran Blood Cholesterol Other Hydrochloride) C Increased Akineton (Biperiden Blood Glucose Increased Hydrochloride) C Blood Lactate Brotizolam C Dehydrogenase Increased Erythema Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Lymphocyte Stimulation Test Positive Malaise Pruritus Date:10/08/03ISR Number: 4208214-0Report Type:Expedited (15-DaCompany Report #JP_030901842 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Zyprexa-Oral Initial or Prolonged Asthenia Health (Olanzapine) Balance Disorder Professional (Olanzapine) PS 10 MG/ 1 DAY Blood Creatine Company Atolant Phosphokinase Increased Representative (Neticonazole Blood Pressure Other Hydrochloride) C Fluctuation Primperan Blood Uric Acid Increased (Metoclopramide) C Cerebral Atrophy Magnesium Oxide C Cylindruria Difficulty In Walking Dizziness Dysstasia Face Oedema Gait Disturbance Hyporeflexia Nausea Oedema Peripheral Protein Urine Present Vomiting 24-Jun-2005 12:19 PM Page: 2507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208216-4Report Type:Expedited (15-DaCompany Report #CA_030906255 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Level Increased Literature (Olanzapine) PS Drug Toxicity Health Oxazepam C Overdose Professional Other Date:10/08/03ISR Number: 4208218-8Report Type:Expedited (15-DaCompany Report #CA_030906256 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Olanzapine-Oral Cerebral Atherosclerosis Literature (Olanzapine) PS Diabetes Mellitus Health Procyclidine C Drug Toxicity Professional Overdose Other Date:10/08/03ISR Number: 4208221-8Report Type:Expedited (15-DaCompany Report #CA_030906258 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Foreign Olanzapine-Oral Breast Cancer Literature (Olanzapine) PS Drug Toxicity Health Codeine C Multiple Drug Overdose Professional Venlafaxine C Other Flurazepam C 2-Oh-Ethylflurazepam C Metoclopramide C Date:10/08/03ISR Number: 4208222-XReport Type:Expedited (15-DaCompany Report #CA_030906259 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Olanzapine-Oral Drug Toxicity Literature (Olanzapine) PS Overdose Health Codeine C Professional Phenytoin C Other Oxycodone C Alprazolam C Citalopram C Date:10/08/03ISR Number: 4208223-1Report Type:Expedited (15-DaCompany Report #CA_030906262 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Olanzapine-Oral Other Completed Suicide Literature (Olanzapine) PS Drug Toxicity Health Overdose Professional Respiratory Failure Other 24-Jun-2005 12:19 PM Page: 2508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208657-5Report Type:Direct Company Report #CTU 203470 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olanzapine 10mg Hospitalization - Syndrome Eli Lilly PS Eli Lilly ORAL 10MG 3 X Initial or Prolonged DAILY ORAL Required Meperidine 100mg Intervention to Wyeth-Ayerst SS Wyeth-Ayerst INTRAMUSCULAR 125MG Q4HRS Prevent Permanent PRN Impairment/Damage INTRAMUSCULAR Fentanyl Patcth C Hydroxyzine C Date:10/09/03ISR Number: 4209215-9Report Type:Expedited (15-DaCompany Report #KII-2003-0002571 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Oxycodone Initial or Prolonged Alanine Aminotransferase Professional Hydrochloride Other Increased (Similar To Nda Aspartate 20-553)(Oxycodone Aminotransferase Hydrochloride) PS ORAL ORAL Increased Zyprexa(Olanzapine) SS ORAL ORAL Blood Glucose Ambien(Zolpidem Blood Potassium Tartrate) SS ORAL ORAL Cells In Urine Chromaturia Intentional Misuse Multiple Drug Overdose Red Blood Cells Urine Respiratory Depth Decreased Somnolence Urinary Casts Urine Output Decreased Date:10/10/03ISR Number: 4209247-0Report Type:Expedited (15-DaCompany Report #HQWYE581909SEP03 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Vandral Retard Syndrome Professional (Venlafaxine Other Hydrochloride, Capsule, Extended Release) PS ORAL 300 MG 1X PER 1 DAY; ORAL 9 DAY Sinemet (Carbidopa/Levodopa, ( SS ORAL 3 DOSE 1X PER 1 DAY; ORAL Zyprexa (Olanzapine, ) SS ORAL 20 MG 1X PER 1 DAY; ORAL Idalprem (Lorazepam) C Rexer (Mirtazapine) C 24-Jun-2005 12:19 PM Page: 2509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/03ISR Number: 4209792-8Report Type:Direct Company Report #USP 080787 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa PS Eli Lilly TABLET Zyrtec SS Pfizer TABLET Date:10/15/03ISR Number: 4210269-4Report Type:Expedited (15-DaCompany Report #M1116-2003 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Mirtazapine PS ORAL 30 MG 9 DAY Syndrome Olanzapine SS ORAL 20 MG 10 DAY Venlafaxine Hydrochloride SS ORAL 300 MG 10 DAY Lorazepam SS ORAL 5 MG 10 DAY Sinemet SS ORAL 3 DF Date:10/15/03ISR Number: 4210270-0Report Type:Expedited (15-DaCompany Report #M1115-2003 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Mirtazapine PS ORAL 60 MG 2 MON Olanzapine SS ORAL 10 MG 2 MON Acetylsalicylic Acid C Pentazol C Losartan Potassium C Lozaar Plus C Metoprolol Succinate C Rifampicin Sodium C Vancomycin C Gentamicin Sulfate C Heparin Fraction, Calcium Salt C Carbocisteine C Amlodipine Besilate C Date:10/15/03ISR Number: 4211071-XReport Type:Expedited (15-DaCompany Report #US_030997774 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Literature Olanzapine-Oral Hospitalization - Increased Health (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Cardio-Respiratory Arrest Professional Paroxetine C Drug Toxicity Hyperpyrexia Hypotension Injection Site Haemorrhage Mental Status Changes Muscle Rigidity Tachycardia Tremor 24-Jun-2005 12:19 PM Page: 2510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4211072-1Report Type:Expedited (15-DaCompany Report #US_030997763 Age:21 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Intentional Misuse Professional Overdose Toxicologic Test Abnormal Date:10/15/03ISR Number: 4211073-3Report Type:Expedited (15-DaCompany Report #US_030997764 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Literature Olanzapine-Oral Hospitalization - Phosphokinase Increased Health (Olanzapine) PS Initial or Prolonged Blood Pressure Systolic Professional Naproxen C Increased Cerebral Haemorrhage Coma Drug Toxicity Heart Rate Increased Hyperglycaemia Hyperpyrexia Hypokalaemia Hypotension Intentional Misuse Suicide Attempt Date:10/15/03ISR Number: 4211085-XReport Type:Expedited (15-DaCompany Report #DSA_23407_2003 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Diltiazem PS Hospitalization - Completed Suicide Health Olanzapine SS Initial or Prolonged Multiple Drug Overdose Professional Date:10/15/03ISR Number: 4211142-8Report Type:Expedited (15-DaCompany Report #2003031466 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Lopid (Gemfibrozil) PS ORAL 12200 MG Initial or Prolonged Mental Disorder Professional (BID), ORAL Other Olanzapine (Olanzapine) SS ORAL ORAL Bupropion Hydrochloride (Bupropion Hydrochloride) C Paroxetine Hydrochloride (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4211143-XReport Type:Expedited (15-DaCompany Report #US_031097975 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Olanzapine-Oral Health (Olanzapine) PS Professional Date:10/15/03ISR Number: 4211146-5Report Type:Expedited (15-DaCompany Report #US_031097926 Age:61 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Literature Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Acetaminophen C Date:10/15/03ISR Number: 4211154-4Report Type:Expedited (15-DaCompany Report #US_031097979 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Multiple Drug Overdose Professional Fluoxetine Hydrochloride-Oral (Fluoxetine) SS Benztropine C Date:10/15/03ISR Number: 4211358-0Report Type:Expedited (15-DaCompany Report #USA030946924 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Zyprexa-Oral Completed Suicide Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 20 MG 9 MON Representative Date:10/15/03ISR Number: 4211475-5Report Type:Expedited (15-DaCompany Report #US_031097937 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Overdose Professional Valproic Acid C Carbamazepine C Date:10/15/03ISR Number: 4211770-XReport Type:Expedited (15-DaCompany Report #USA030948573 Age:46 YR Gender:Male I/FU:I Outcome PT Abdominal Pain Asthenia Constipation Dizziness Dry Throat Dyspnoea Nervous System Disorder Oropharyngeal Swelling 24-Jun-2005 12:19 PM Page: 2512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rectal Haemorrhage Throat Tightness Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/DAY 6 WK Lithium C Prevacid (Lansoprazole) C Lamictal (Lamotrigine) C Date:10/15/03ISR Number: 4211772-3Report Type:Expedited (15-DaCompany Report #USA030948579 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Increased (Olanzapine) Gallbladder Disorder (Olanzapine) PS 10 MG/DAY 3 WK Gamma-Glutamyltransferase Synthroid Increased (Levothyroxine High Density Lipoprotein Sodium) C Increased Ambien (Zolpidem Low Density Lipoprotein Tartrate) C Increased Renal Pain Date:10/15/03ISR Number: 4211774-7Report Type:Expedited (15-DaCompany Report #USA030948512 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa-Oral Professional (Lonazapine (Olanzapine) PS Date:10/15/03ISR Number: 4213420-5Report Type:Expedited (15-DaCompany Report #JP_030901799 Age:2 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniotic Cavity Infection Foreign Zyprexa-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS Drugs Company Infection Representative Maternal Drugs Affecting Other Foetus Pregnancy Premature Rupture Of Membranes Tachypnoea Umbilical Hernia 24-Jun-2005 12:19 PM Page: 2513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4213421-7Report Type:Expedited (15-DaCompany Report #JP_030801654 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa-Oral Initial or Prolonged Consciousness Study (Olanzapine) Hypochloraemia Health (Olanzapine) PS 10 MG/DAY Hyponatraemia Professional Lullan (Perospirone Water Intoxication Other Hydrochloride) C Depas (Etizolam) C Setous (Zotepine) C Benzalin (Nitrazepam) C Isomytal (Amobarbital) C Brovarin (Bromisoval) C Picoben (Sodium Picosulfate) C Date:10/15/03ISR Number: 4213492-8Report Type:Expedited (15-DaCompany Report #DE_030511395 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Hospitalization - Blood Creatinine Health (Olanzapine) Initial or Prolonged Increased Professional (Olanzapine) PS 20 MG/DAY Blood Urea Increased Company Euthyrox(Levothyroxi Brain Oedema Representative ne Sodium) C Neuroleptic Malignant Other Truxal(Chlorprothixe Syndrome ne Hydrochloride) C Pulmonary Embolism Adalat(Nifedipine) C Rhabdomyolysis Euglucon(Glibenclami Ventricular Hypertrophy de) C Heparin C Date:10/15/03ISR Number: 4213494-1Report Type:Expedited (15-DaCompany Report #DE_030911980 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Zyprexa-Oral Initial or Prolonged Conversion Disorder Health (Olanzapine) Drug Interaction Professional (Olanzapine) PS 10 MG/DAY 6 WK Drug Level Increased Other Fevarin(Fluvoxamine Rhabdomyolysis Maleate) C Vomiting Date:10/15/03ISR Number: 4213496-5Report Type:Expedited (15-DaCompany Report #DE_030912041 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Zyprexa-Oral Life-Threatening Syndrome Health (Olanzapine) Hospitalization - Pneumonia Professional (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Other Nipolept(Zotepine) C Diazepam C Akineton(Biperiden Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4213718-0Report Type:Expedited (15-DaCompany Report #EWC030936250 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Olanzapine-Oral Blood Lactate Health (Olanzapine) PS 20 MG/DAY Dehydrogenase Increased Professional Chest Pain Other Cryoglobulins Present Dyspnoea Exertional Elliptocytosis Erythroleukaemia Fatigue Haptoglobin Decreased Red Blood Cell Spherocytes Present Tachypnoea Thrombocytopenia Date:10/15/03ISR Number: 4213720-9Report Type:Expedited (15-DaCompany Report #JP_030901717 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY Company Representative Other Date:10/15/03ISR Number: 4213865-3Report Type:Expedited (15-DaCompany Report #GBS030913791 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Olanzapine-Oral Ejection Fraction Health (Olanzapine) PS 2.5 MG/4 DAY Decreased Professional Lustral (Sertraline Left Ventricular Failure Other Hydrochloride) C Haloperidol C Procyclidine C Date:10/15/03ISR Number: 4213987-7Report Type:Expedited (15-DaCompany Report #EWC031036414 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematochezia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Representative Other Date:10/15/03ISR Number: 4214022-7Report Type:Expedited (15-DaCompany Report #JP_030901751 Age:25 YR Gender:Male I/FU:I Outcome PT Other Abdominal Pain Blood Triglycerides 24-Jun-2005 12:19 PM Page: 2515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Diarrhoea Glycosylated Haemoglobin Increased Report Source Product Role Manufacturer Route Dose Duration Headache Foreign Zyprexa-Oral Hepatic Function Abnormal Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS 10 MG/DAY Weight Increased Company Brotizolam C Representative Other Date:10/15/03ISR Number: 4214136-1Report Type:Expedited (15-DaCompany Report #EWC031036417 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine Initial or Prolonged Phosphokinase Bb Health (Olanzapine) PS ORAL 10 MG/DAY Increased Professional Citalopram C Blood Creatine Other Tiklid (Ticlopidine Phosphokinase Increased Hydrochloride) C Blood Creatine Nitrosylon (Glyceryl Phosphokinase Mm Trinitrate) C Increased Blood Lactate Dehydrogenase Increased Hyperpyrexia Psychomotor Retardation Pulmonary Embolism Date:10/15/03ISR Number: 4214210-XReport Type:Expedited (15-DaCompany Report #JP_030901731 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa-Oral Initial or Prolonged Autoimmune Hepatitis Health (Olanzapine) Blood Creatine Professional (Olanzapine) PS 20 MG/DAY Phosphokinase Company Luvox(Fluvoxamine Glucose Urine Present Representative Maleate) C Hyperglycaemia Other Risperdal(Risperidon Hypotension e) C Nausea Solanax(Alprazolam) C Polydipsia Biperiden C Pyrexia Dihydroergotamine Vomiting Mesilate C Midodrine Hydrochloride C Date:10/15/03ISR Number: 4214213-5Report Type:Expedited (15-DaCompany Report #JP_031001909 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Upper Gastrointestinal Foreign Zyprexa-Oral Initial or Prolonged Haemorrhage Study (Olanzapine) Health (Olanzapine) PS 10 MG/DAY Professional Zopiclone C Other Selbex(Teprenone) C Vitamin B Complex C Magnesium Oxide C Gasmotin(Mosapride 24-Jun-2005 12:19 PM Page: 2516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citrate) C Date:10/17/03ISR Number: 4211175-1Report Type:Direct Company Report #CTU 204045 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Zyprexa 10 Mg PS ONCE/DAY Initial or Prolonged Extrapyramidal Disorder Klonopin 1 Mg SS 4-5 MG/DA Disability Parkinsonism Prozac C Other Rectal Haemorrhage Lamictol C Required Retching Provigil C Intervention to Vision Blurred Wellbutrin C Prevent Permanent Weight Decreased Abilitify C Impairment/Damage Serzone C Trazodone C Date:10/17/03ISR Number: 4214609-1Report Type:Expedited (15-DaCompany Report #HQWYE050807OCT03 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Vandral Retard Hospitalization - Syndrome Professional (Venlafaxine Initial or Prolonged Other Hydrochloride, Capsule, Extended Release) PS ORAL 300 MG 1X PER 1 DAY 9 DAY Idalprem (Lorazepam, ) SS ORAL 5 MG 1X PER 1 DAY 9 DAY Rexer (Mirtazapine, ) SS ORAL 30 MG 1X PER 1 DAY 9 DAY Sinemet-Plus (Carbidopa/Levodopa, ) SS ORAL *3 DF/DAY" Zyprexa (Olanzapine, ) SS ORAL 20 MG 1X PER 1 DAY 9 DAY Date:10/17/03ISR Number: 4214611-XReport Type:Expedited (15-DaCompany Report #HQWYE581909SEP03 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Vandral Retard Syndrome Professional (Venlafaxine Other Hydrochloride, Capsule, Extended Release) PS ORAL 300 MG 1X PER 1 DAY 9 DAY Sinemet (Carbidopa/Levodopa, ) SS ORAL 3 DOSE 1X PER 1 DAY Zyprexa (Olanzapine, ) SS ORAL 20 MG 1X PER 1 DAY 9 DAY Idalprem (Lorazepam) C Rexer (Mirtazapine) C 24-Jun-2005 12:19 PM Page: 2517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/03ISR Number: 4215813-9Report Type:Expedited (15-DaCompany Report #JP_030801637 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Zyprexa-Oral Cardio-Respiratory Arrest Health (Olanzapine) Chest Discomfort Professional (Olanzapine) PS 5 MG/D AT Cough Company BEDTIME Cyanosis Representative Zyloric C Depressed Level Of Other Zantac (Ranitidine Consciousness Hydrochloride) C Hypoxia Gasmotin (Mosapride Oedema Citrate) C Respiratory Depression Monilac (Lactulose) C Digoxin C Nauzelin (Domperidone) C Topicain (Oxetacaine) C Dogmatyl (Sulpiride) C Myslee (Zolpidem Tarttrate) C Voltaren (Diclofenac Sodium) C Aldactone-A (Spironolactone) C Depas (Etizolam) C Azunol(Sodium Gualenate) C Mucodyne (Carbocisteine) C Gatifloxacin C Tetramide (Mianserin Hydrochloride) C Benzalin (Nitrazepam) C Contomin (Chlorpromazine Hydrochlioride) C Lactose C Aminofluid C Maxipime (Cefepime Hydrochloride) C Isepacin (Isepacin Sulfate) C Dalacin-S (Clindamycin) C Lasix (Furosemide) C Clindamycin C Date:10/21/03ISR Number: 4215818-8Report Type:Expedited (15-DaCompany Report #JP_030901692 Age:43 YR Gender:Male I/FU:F Outcome PT Other Blood Glucose Increased Condition Aggravated Erythema Hepatic Function Abnormal Hepatic Steatosis Hepatitis Lymphocyte Stimulation 24-Jun-2005 12:19 PM Page: 2518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Test Positive Malaise Pruritus Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Toledomin Representative (Milnacipran Other Hydrochloride) C Akineton (Biperiden Hydrochloride) C Brotizolam C Date:10/21/03ISR Number: 4215823-1Report Type:Expedited (15-DaCompany Report #JP_030901726 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Zyprexa-Oral Initial or Prolonged Respiratory Failure Health (Olanzapine) Disability Professional (Olanzapine) PS 10 MG/DAY Company Serenace C Representative Depas (Etizolam) C Other Artane (Trihexyphenidyl Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Fursennide (Senna Leaf) C Date:10/21/03ISR Number: 4215827-9Report Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Zyprexa-Oral Initial or Prolonged Oedema Peripheral Health (Olanzapine) Pulmonary Oedema Professional (Olanzapine) PS 10 MG/DAY Pyrexia Company Amoban (Zopiclone) C Respiratory Failure Representative Cercine (Diazepam) C Rhabdomyolysis Other Cefazolin Sodium C Cravit (Levofloxacin) C Pedipin La (Nicardipine Hydrochloride) C Heparin C Lasix (Furosemide) C Mannitol C Epogin (Epoetin Beta) C Date:10/21/03ISR Number: 4215898-XReport Type:Expedited (15-DaCompany Report #EWC031036524 Age: Gender:Female I/FU:I Outcome PT Report Source Death Completed Suicide Foreign Health 24-Jun-2005 12:19 PM Page: 2519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS Citalopram C Date:10/21/03ISR Number: 4215900-5Report Type:Expedited (15-DaCompany Report #JP_031001932 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Hyperglycaemia Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Levotomin Representative (Levomepromazine Other Maleate) C Sepazon (Cloxazolam) C Cercine (Diazepam) C Depas (Etizolam) C Doral (Quazepam) C Eurodin (Estazolam) C Paxil (Paroxetine Hydrochloride) C Date:10/21/03ISR Number: 4215902-9Report Type:Expedited (15-DaCompany Report #DE_031012161 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Foreign Zyprexa-Oral Initial or Prolonged Drug Toxicity Health (Olanzapine) Professional (Olanzapine) PS 5 MG/2 DAY Other Remergil (Mirtazapine) C Ass C Pantozol (Pantoprazole Sodium) C Sortis (Atorvastatin Calcium) C Lorzaar (Losartan Potassium) C Isoket Retard (Isosorbide Dinitrate) C Corvaton - Slow Release (Molsidomine) C Lozaar Plus C Beloc Zok (Metoprolol Succinate) C Norvasc (Amlodiine Besilate) C Vancomycin C Gentamycin C Fraxiparin (Heparin-Fraction, Calcium Salt) C 24-Jun-2005 12:19 PM Page: 2520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bifiteral (Lactulose) C Klistier C Lecicarbon C Eremfat (Rifamicin Sodium) C Date:10/21/03ISR Number: 4215904-2Report Type:Expedited (15-DaCompany Report #EWC031036487 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phaeochromocytoma Foreign Olanzapine-Oral Initial or Prolonged Secondary Hypertension Health (Olanzapine) PS 10 MG/DAY Tachycardia Professional Truxal Other (Chlorprothixene Hydrochloride) C Seroquel (Quetiapine Fumarate) C Clopixol (Zucluphenthixol Decanoate) C Valium (Diazepam) C Akineton Retard (Biperiden Hydrochloride) C Date:10/21/03ISR Number: 4215942-XReport Type:Expedited (15-DaCompany Report #USA031049272 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Zyprex-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Date:10/21/03ISR Number: 4215987-XReport Type:Expedited (15-DaCompany Report #JP_030901826 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Other Parkinsonism Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Valerin (Valproate Representative Sodium) C Other Depas (Etizolam) C Luvox (Fluvoxamine Maleate) C Silece (Flunitrazepam) C Lendormin (Brotizolam) C Diazepam C Sennoside A+B C 24-Jun-2005 12:19 PM Page: 2521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/03ISR Number: 4215990-XReport Type:Expedited (15-DaCompany Report #EWC031036417 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 10 MG/DAY Blood Creatine Professional Citalopram C Phosphokinase Mb Other Tiklid (Ticlopidine Increased Hydrochloride) C Blood Lactate Nitrosylon (Glyceryl Dehydrogenase Increased Trinitrate) C Enzyme Abnormality Hyperpyrexia Psychomotor Retardation Pulmonary Embolism Date:10/21/03ISR Number: 4215993-5Report Type:Expedited (15-DaCompany Report #CA_030806143 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Zyprexa-Oral Pneumonia Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Clonazepam C Representative Effexor (Venlafaxine Other Hydrochloride) C Lamotrigine C Date:10/21/03ISR Number: 4216046-2Report Type:Expedited (15-DaCompany Report #USA030844952 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Health Zyprexa-Oral Other Asthenia Professional (Olanzapine) PS 2.5 MG Deafness Coumadin (Warfarin Diabetes Mellitus Sodium) C Inadequate Control Plavix (Clopidogrel Memory Impairment Sulfate) C Personality Change Aspirin C Transient Ischaemic Ambien (Zolpidem Attack Tartrate) C Wheelchair User Humalog (Insulin Lispro) C Lantus (Insulin Glargine) C Effexor-Xr (Venlafaxine Hydrochloride) C Protonix (Pantoprazole) C Date:10/21/03ISR Number: 4217079-2Report Type:Expedited (15-DaCompany Report #USA031049346 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ecchymosis Health Zyprexa-Oral Rash Professional (Olanzapine) Vasculitis (Olanzapine) PS 7.5 MG/DAY 24-Jun-2005 12:19 PM Page: 2522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/03ISR Number: 4217083-4Report Type:Expedited (15-DaCompany Report #USA031049154 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa-Oral Abnormal Professional (Olanzapine) Stevens-Johnson Syndrome Company (Olanzapine) PS Representative Date:10/21/03ISR Number: 4217085-8Report Type:Expedited (15-DaCompany Report #USA031049093 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Health Zyprexa-Oral Initial or Prolonged Pregnancy Professional (Olanzapine) Pregnancy (Olanzapine) PS 20 MG/DAY Prozac-Oral (Fluoxetine ) (Fluoxetine Hydrochloride) SS 60 MG/DAY Clonazepam C Date:10/21/03ISR Number: 4217439-XReport Type:Expedited (15-DaCompany Report #USA030946224 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa-Oral Initial or Prolonged Jaundice Professional (Olanzapine) Other Urinary Tract Infection Company (Olanzapine) PS 10 MG/ AT Representative BEDTIME Date:10/22/03ISR Number: 4215253-2Report Type:Direct Company Report #CTU 204292 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Xanax PS Initial or Prolonged Somnolence Olanzapine SS Buspirone SS Sertraline C Date:10/23/03ISR Number: 4217381-4Report Type:Expedited (15-DaCompany Report #FRWYE195330JUN03 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seresta Initial or Prolonged Hyponatraemia Health (Oxazeapm) PS ORAL 50 MG4X PER 1 Other Loss Of Consciousness Professional DAY ORAL 51 DAY Lymphocyte Count Other Athymil (Mianserin Decreased Hydrochloride) SS ORAL 60 MG 1X PER Pyrexia A DAY ORAL 29 DAY Renal Failure Gabacet (Piracetam) SS 1 YR Syncope Mediator (Benfluorex White Blood Cell Count Hydrochoride, , 0) SS 13 DAY Decreased Mepronizine (Aceprometazine/Mepr obamate) SS 1 YR Nozianan (Levomepromazine) SS ORAL 25 MG 3X PER 24-Jun-2005 12:19 PM Page: 2523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY ORAL 29 DAY Stilnox (Zolpidem, ,0) SS Tegretol (Carbamazepine, , 0) SS ORAL 200 MG 2X PER 1 DAY ORAL / SEE IMAGE 29 DAY Zoloft (Sertraline Hydrochloride, , 0) SS ORAL 50 MG 2X PER 1 DAY ORAL 29 DAY Zyprexa (Olanzapine, ,0) SS ORAL 5 MG 2X PER 1 DAY ORAL 29 DAY Date:10/23/03ISR Number: 4217426-1Report Type:Expedited (15-DaCompany Report #03P-167-0236608-00 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Depakote (Divalproex Intervention to Health Sodium) PS Prevent Permanent Professional Olanzapine SS Impairment/Damage Date:10/24/03ISR Number: 4219831-6Report Type:Expedited (15-DaCompany Report #2003019160 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Nardil (Phenelzine Initial or Prolonged Anorgasmia Sulfate) PS 37 MG (DAILY) Drug Interaction Quetiapine Fumarate Dry Mouth (Quetiapine Headache Fumarate) SS 50 MG (DAILY) Hypersomnia Olanzapine Insomnia (Olanzapine) SS Mental Disorder Lithium Carbonate Nausea (Lithium Carbonate) SS 900 MG (BID) Rapid Eye Movements Sleep Lamotrigine Abnormal (Lamotrigine) SS 50 MG Salivary Gland Disorder Novothyral Skin Disorder (Levothyroxine Weight Increased Sodium, Liothyronine Sodium) C Date:10/27/03ISR Number: 4219657-3Report Type:Direct Company Report #CTU 204635 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Olanzapine-Zyprexa- Non-Insulin-Dependent 10 Mg Lilly PS Lilly ORAL 10 MG QD ORAL Date:10/27/03ISR Number: 4219723-2Report Type:Direct Company Report #CTU 204640 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Zyprexa 5mg PS Intervention to Polydipsia Seroquel SS Prevent Permanent Weight Decreased Impairment/Damage 24-Jun-2005 12:19 PM Page: 2524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/03ISR Number: 4220934-0Report Type:Expedited (15-DaCompany Report #2003AP03753 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Tamoxifen PS 40 MG DAILY Deep Vein Thrombosis Literature Olanzapine SS 5 MG DAILY Dehydration Health Potassium Chloride C Delusion Professional Magnesium Hydroxide C Depressed Level Of Other Calcium Carbonate C Consciousness Lactulose C Depression General Physical Health Deterioration Hypoalbuminaemia Hypocalcaemia Hypokalaemia Hypotension Oedema Peripheral Oral Intake Reduced Pulmonary Embolism Sinus Tachycardia Tachypnoea Date:10/28/03ISR Number: 4221255-2Report Type:Direct Company Report #CTU 204770 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 2.5mg PS 2.5 MG DAILY Prilosec C Synthroid C Lexapro C Atenolol C Date:10/28/03ISR Number: 4222275-4Report Type:Expedited (15-DaCompany Report #EWC031036562 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arterial Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG/DAY Professional Nozinan Other (Levomepromazine) C Date:10/28/03ISR Number: 4222276-6Report Type:Expedited (15-DaCompany Report #DE_031012192 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa-Oral Bronchitis Health (Olanzapine) PS 40 MG/DAY 2 DAY Coronary Artery Occlusion Professional Valium (Diazepam) C Hypoxia Company Rohypnol Prescribed Overdose Representative (Flunitrazepam) C Other Lithium C Magnesium C 24-Jun-2005 12:19 PM Page: 2525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4222277-8Report Type:Expedited (15-DaCompany Report #DE_031012203 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 15 MG/DAY Food Aversion Professional Pipamperone C Gait Disturbance Company General Nutrition Representative Disorder Other Pyrexia Restlessness Date:10/28/03ISR Number: 4222278-XReport Type:Expedited (15-DaCompany Report #EWC030735466 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anoxia Foreign Zyprexa-Oral Initial or Prolonged Atrophy Health (Olanzapine) PS 5 MG/DAY Blood Glucose Decreased Professional Haldol (Haloperidol) C Blood Urea Increased Other Cordarone Coma (Amiodarone Myoclonic Epilepsy Hydrochloride) C Date:10/28/03ISR Number: 4222293-6Report Type:Expedited (15-DaCompany Report #EWC031036634 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Generalised Foreign Olanzapine-Oral Exanthematous Pustulosis Health (Olanzapine) PS 10 MG/DAY Rash Erythematous Professional Fluoxetine-Oral Other (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/DAY Mirtazapine C Midazolam C Tranxilium (Clorazepate Dipotassium) C Clotiapine C Valproic Acid C Date:10/28/03ISR Number: 4222569-2Report Type:Expedited (15-DaCompany Report #US_030795917 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Zyrpexa-Oral Colonic Polyp (Olanzapine) Diabetes Mellitus (Olanzapine) PS 5 MG/DAY Diverticulum Lopid (Gemfibrozil) C Fatigue Valium (Diazepam) C Gastrointestinal Aspirin (E.C.) Haemorrhage (Acetylsalicylic Haemorrhoidal Haemorrhage Acid) C Ketoacidosis Glucotrol Xl Pancreatitis (Quinapril Pneumonia Mycoplasmal Hydrochloride) C Prothrombin Time Accupril (Quinapril Prolonged Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochlorothiazide C Glucophage (Metformin Hydrochloride) C Date:10/28/03ISR Number: 4222572-2Report Type:Expedited (15-DaCompany Report #USA031049600 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Neoplasm Health Zyprexa-Oral Initial or Prolonged Pancreatitis Acute Professional (Olanapine) Other (Olanzapine) PS 15 MG Depakote (Valproate Semisodium) C Date:10/28/03ISR Number: 4222575-8Report Type:Expedited (15-DaCompany Report #USA031049545 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conduction Disorder Health Zyprexa-Oral Convulsion Professional (Olanzapine) Hypoxia (Olanzapine) PS 5 MG/DAY 2 DAY Date:10/28/03ISR Number: 4222673-9Report Type:Expedited (15-DaCompany Report #USA030947719 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Strattera Initial or Prolonged Drug Effect Decreased (Atomoxetine Increased Appetite Hydrochloride) PS 80 MG/2 DAY Psychomotor Hyperactivity Zyprexa - Oral Treatment Noncompliance (Olanzapine) Weight Increased (Olanzapine) SS 5 MG/DAY Date:10/28/03ISR Number: 4222683-1Report Type:Expedited (15-DaCompany Report #JP_030300503 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Drug Ineffective Health (Olanzapine) Hyperammonaemia Professional (Olanzapine) PS 20 MG/DAY Mood Altered Company Levotomin Representative (Levomepromazine Maleate) C Valerin (Valproate Sodium) C Thyradin S (Levothyroxine Sodium) C Pursennid (Senna Leaf) C Bromperidol C 24-Jun-2005 12:19 PM Page: 2527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4222777-0Report Type:Expedited (15-DaCompany Report #US_030494123 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Consumer Zyprexa-Oral Other Distress Syndrome (Olanzapine) Anuria (Olanzapine) PS Blood Chloride Depakote(Valproate Blood Creatinine Semisodium) C Blood Ph Increased Prilosec(Omeprazole) C Blood Potassium Trazodone C Blood Sodium Clonidine C Blood Urea Neurontin(Gabapentin Cardiac Arrest ) C Coma Prozac (Fluoxetine Csf White Blood Cell Hydrochloride) C Count Positive Verapamil C Diabetes Mellitus Buspar(Buspirone Disorientation Hydrochloride) C Disseminated Intravascular Coagulation Dysarthria Epistaxis Fatigue Haematocrit Haemoglobin Hypotension Lymphocyte Count Mean Cell Haemoglobin Mean Cell Volume Multi-Organ Failure Neutrophil Count Pco2 Pneumonia Red Blood Cell Count Sepsis White Blood Cell Count Date:10/28/03ISR Number: 4222944-6Report Type:Expedited (15-DaCompany Report #2003112431 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Consumer Geodon Chest Pain (Zirasidone) PS INTRAVENOUS INTRAVENOUS Dizziness Olanzapine Feeling Abnormal (Olanzapine) SS ORAL ORAL Medication Error Haloperidol Prostate Cancer (Haloperidol) C Weight Fluctuation Date:10/28/03ISR Number: 4223037-4Report Type:Expedited (15-DaCompany Report #JP_031001997 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zyprexa-Oral Initial or Prolonged Insomnia Study (Olanzapine)(Olanzap Pneumonia Aspiration Health ine) PS 5 MG/DAY Professional Hirnamin(Levomeproma Other zine) C Rivotril 24-Jun-2005 12:19 PM Page: 2528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Trihexyphenidyl Hydrochloride C Neurovitan C Gramalil(Tiapride Hydrochloride) C Rohypnol (Flunitrazepam) C Tinelac(Sennoside A+B) C Date:10/28/03ISR Number: 4223038-6Report Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Foreign Zyprexa-Oral Crackles Lung Health (Olanzapine)(Olanzap Decreased Appetite Professional ine) PS 10 MG/DAY Depressed Level Of Company Serenace(Haloperidol Consciousness Representative ) C Diabetic Coma Other Diabetic Ketoacidosis Heart Rate Increased Hyperventilation Hypotension Malaise Metabolic Acidosis Nausea Obesity Oliguria Renal Failure Respiratory Rate Increased Tachypnoea Thirst Urine Ketone Body Present Vomiting Date:10/28/03ISR Number: 4223039-8Report Type:Expedited (15-DaCompany Report #EWC031036635 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Allergic Foreign Olanzapine-Oral Health (Olanzapine0 PS 5 MG/DAY Professional Lorazepam C Other Date:10/28/03ISR Number: 4223040-4Report Type:Expedited (15-DaCompany Report #EWC031036640 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Olanzapine-Oral Initial or Prolonged Eyelid Oedema Health (Olanzapine) PS 20 MG/DAY Other Pyrexia Professional Topiramate C Rash Erythematous Other Oxazepam C Swelling Face Zolpidem C Urticaria Risperidone C 24-Jun-2005 12:19 PM Page: 2529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4223041-6Report Type:Expedited (15-DaCompany Report #EWC031036662 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Urinary Tract Infection Health (Olanzapine) PS 10 MG/DAY Professional Lorazepam C Other Valerian Extract C Chloral Hydrate C Atenolol C Esomeprazole C Chondroitin Sulfate C Date:10/28/03ISR Number: 4223108-2Report Type:Expedited (15-DaCompany Report #JP_030300513 Age:51 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Foreign Zyprexa-Oral Initial or Prolonged Blood Glucose Health (Olanzapine) Other Blood Sodium Professional (Olanzapine) PS 10 MG/DAY Grand Mal Convulsion Company Valerin (Valproate Hyperammonaemia Representative Sodium) C Irritability Pursennid (Senna Social Avoidant Behaviour Leaf) C Magnesium Oxide C Risperidone C Date:10/28/03ISR Number: 4223109-4Report Type:Expedited (15-DaCompany Report #JP_030901692 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Company Toledomin Increased Representative (Milnacipran Blood Cholesterol Hydrochloride) C Increased Akineton (Biperiden Blood Glucose Increased Hydrochloride) C Condition Aggravated Brotizolam C Erythema Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hepatic Steatosis Lymphocyte Stimulation Test Positive Malaise Pruritus Date:10/28/03ISR Number: 4223110-0Report Type:Expedited (15-DaCompany Report #JP_030901695 Age:33 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Anxiety Aspartate Aminotransferase 24-Jun-2005 12:19 PM Page: 2530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Alkaline Phosphatase Increased Blood Lactate Report Source Product Role Manufacturer Route Dose Duration Dehydrogenase Increased Foreign Zyprexa-Oral Gastritis Health (Olanzapine) Hepatic Function Abnormal Professional (Olanzapine) PS 20 MG/DAY Hepatitis Company Contomin Jaundice Representative (Chlorpromazine Suicide Attempt Hydrochloride) C Impromen (Bromperidol) C Vegetamin B C Akineton (Biperiden Hydrochloride) C Brotizolam C Benzalin (Nitrazepam) C Rohypnol (Flunitrazepam) C Date:10/28/03ISR Number: 4223112-4Report Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Zyprexa-Oral Hospitalization - Pulmonary Oedema Health (Olanzapine) Initial or Prolonged Pyrexia Professional (Olanzapine) PS 10 MG/DAY Respiratory Failure Company Amoban (Zopiclone) C Rhabdomyolysis Representative Cercine (Diazepam) C Cefazolin Sodium C Cravit (Levofloxacin) C Perdipin La (Nicardipine Hydrochloride) C Heparin C Lasix (Furosemide) C Mannitol C Epogin (Epoetin Beta) C Date:10/28/03ISR Number: 4223114-8Report Type:Expedited (15-DaCompany Report #JP_031001932 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Hyperglycaemia Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Levotomin Representative (Leomepromazine Maleate) C Sepazon (Cloxazolam) C Cercine (Diazepam) C Depas (Etizolam) C Doral (Quazepam) C Eurodin (Estazolam) C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4223177-XReport Type:Expedited (15-DaCompany Report #US_030997518 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Consumer Zyprexa-Oral Other Angiopathy (Olanzapine)(Olanzap Chest Pain ine) PS 30 MG/AT Constipation BEDTIME Diabetes Mellitus Indapamine C Diabetes Mellitus Docusate Sodium C Inadequate Control Zoloft(Sertraline Diabetic Ketoacidosis Hydrochloride) C Dilatation Ventricular Clonazepam C Dizziness Depakote (Valproate Dysarthria Semisodium) C Dysstasia Metamucil(Psyllium Glycosylated Haemoglobin Hydrophilic Increased Mucilloid) C Haemoptysis Ibuprofen C Headache Hypersomnia Hypoaesthesia Insomnia Lethargy Loss Of Consciousness Metabolic Disorder Nausea Oral Intake Reduced Pain In Jaw Pulmonary Oedema Pulse Absent Respiratory Arrest Respiratory Tract Congestion Rhinorrhoea Staring Vision Blurred Date:10/29/03ISR Number: 4223361-5Report Type:Expedited (15-DaCompany Report #USA-2003-0007532 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Oxycodone Completed Suicide Professional Hydrochloride PS Intentional Misuse Other Hydrocodone Multiple Drug Overdose Bitartrate (Similar Pulmonary Congestion To Ind Pulmonary Oedema 59,175)(Naltrexone, Paracetamol, SS Acetaminophen(Parace tamol) SS Mirtazapine(Mirtazap ine) SS Alprazolam(Alprazola m) SS Olanzapine(Olanzapin e) SS Sertraline(Sertralin e) SS Trazodone(Trazodone) SS Bupropion(Amfebutamo 24-Jun-2005 12:19 PM Page: 2532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ne) SS Date:10/30/03ISR Number: 4224025-4Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20031004828 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Topamax (Topiramate) Initial or Prolonged Drug Interaction Health Unspecified PS SEE IMAGE Pyrexia Professional Zyprexa (Olanzapine) SS SEE IMAGE Risperdal (Risperidone) C Stilnox (Zolpidem) C Seresta (Oxazepam) C Date:10/30/03ISR Number: 4224282-4Report Type:Expedited (15-DaCompany Report #03P-167-0236608-00 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Depakote (Divalproex Initial or Prolonged Lower Respiratory Tract Health Sodium) (Divalproex Required Infection Professional Sodium) PS Intervention to White Blood Cell Count Olanzapine SS Prevent Permanent Decreased Impairment/Damage Date:10/31/03ISR Number: 4223749-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-350260 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Scan Abnormal Valium PS Roche ORAL 20 DAY Hospitalization - Cerebral Atrophy Theralene SS ORAL Initial or Prolonged Confusional State Zyprexa SS ORAL 24 DAY Klebsiella Infection Tercian C ORAL 20 DAY Pneumonia Aspiration Lepticur C ORAL 24 DAY Psychomotor Retardation Depakote C UNKNOWN Respiratory Failure Imovane C ORAL Date:10/31/03ISR Number: 4225288-1Report Type:Expedited (15-DaCompany Report #03P-163-0238291-00 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Valproic Acid Body Temperature Literature (Depakene) (Valproic Increased Health Acid) (Valproic Grand Mal Convulsion Professional Acid) PS ORAL 7-10 TABLETS, Heart Rate Increased ORAL Hypertension Levothyroxine SS Intentional Misuse Olanzapine SS 7-10 TABLETS Oxygen Saturation Decreased Pulse Absent Respiratory Rate Increased Thyrotoxic Crisis Ventricular Fibrillation 24-Jun-2005 12:19 PM Page: 2533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4226464-4Report Type:Expedited (15-DaCompany Report #K200301719 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Literature Levoxyl Grand Mal Convulsion Health (Levothyroxine) Intentional Misuse Professional Tablet, 25mcg PS ORAL Pulse Absent Olanzapine Thyrotoxic Crisis (Olanzapine) SS ORAL ORAL Ventricular Fibrillation Valproic Acid (Valproic Acid) SS ORAL Date:11/03/03ISR Number: 4226871-XReport Type:Expedited (15-DaCompany Report #2003-DE-05108GD Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Methadone Completed Suicide (Methadone) PS ORAL PO Multiple Drug Overdose Olanzapine SS ORAL PO Gabapentin (Gabapentin) SS ORAL PO Date:11/03/03ISR Number: 4227099-XReport Type:Expedited (15-DaCompany Report #2003-DE-05105GD Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Methadone Overdose (Methadone) PS ORAL PO Respiratory Arrest Olanzapine SS ORAL PO Date:11/04/03ISR Number: 4227460-3Report Type:Expedited (15-DaCompany Report #M1252-2003 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Mirtazapine PS DF Initial or Prolonged Rhabdomyolysis Professional Olanzapine SS DF Metoprolol Tartrate SS DF Zopiclone SS DF Diazepam SS DF Date:11/04/03ISR Number: 4227500-1Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20031004532 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Erythropenia Health (Risperidone) PS ORAL SEE IMAGE, Leukopenia Professional ORAL Zyprexa (Olanzapine) SS SEE IMAGE Combivir (Zidovudine W/Lamivudine) SS 300 MG Viracept (Nelfinavir Mesilate C 24-Jun-2005 12:19 PM Page: 2534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/03ISR Number: 4228470-2Report Type:Expedited (15-DaCompany Report #USA031050501 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa Initial or Prolonged Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Depakote (Valproate Semisodium) C Date:11/05/03ISR Number: 4228471-4Report Type:Expedited (15-DaCompany Report #USA031050193 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Benadryl (Diphenhydramine Hydrochloride) C Date:11/05/03ISR Number: 4228474-XReport Type:Expedited (15-DaCompany Report #USA031050393 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Health Zyprexa-Oral Hospitalization - Confusional State Professional (Olanzapine) Initial or Prolonged Pancreatitis Acute (Olanzapine) PS 20 MG Pollakiuria Seroquel (Quetiapine Polydipsia Fumarate) C Paxil (Paroxetine Hydrochloride) C Date:11/05/03ISR Number: 4228611-7Report Type:Expedited (15-DaCompany Report #US_031098328 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Literature Olanzapine-Oral Increased Health (Olanzapine) PS 1 MON Aspartate Professional Nortriptyline C Aminotransferase Divalproex Sodium C Increased Blood Lactate Dehydrogenase Increased Drug Interaction Mood Altered Pancreatitis Date:11/05/03ISR Number: 4228612-9Report Type:Expedited (15-DaCompany Report #US_031098331 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Literature Olanzapine-Oral Increased Health (Olanzapine) PS 41 WK Drug Interaction Professional Divalproex Sodium C Hepatic Steatosis Weight Increased 24-Jun-2005 12:19 PM Page: 2535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/03ISR Number: 4228613-0Report Type:Expedited (15-DaCompany Report #USA031050800 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa Initial or Prolonged Professional Zydis-Dispersible(Ol Company anazapine) Representative (Olanazapine) PS Date:11/05/03ISR Number: 4228614-2Report Type:Expedited (15-DaCompany Report #USA031050802 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa Initial or Prolonged Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Date:11/05/03ISR Number: 4228615-4Report Type:Expedited (15-DaCompany Report #USA031050803 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa Initial or Prolonged Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Date:11/05/03ISR Number: 4228616-6Report Type:Expedited (15-DaCompany Report #USA031050804 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa Initial or Prolonged Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Date:11/05/03ISR Number: 4228629-4Report Type:Expedited (15-DaCompany Report #USA031050618 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Oedema Consumer Prozac-Oral Drug Ineffective (Fluoxetine) Insomnia (Fluoxetine Nervousness Hydrochloride) PS 20 MG Somnolence Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG Lipitor (Atorvastatin) C Timoptic (Timolol Maleate) C Trazadone (Trazodone) C Hydrochlorothiazide C ... C 24-Jun-2005 12:19 PM Page: 2536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/03ISR Number: 4228637-3Report Type:Expedited (15-DaCompany Report #USA031050414 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/05/03ISR Number: 4228755-XReport Type:Expedited (15-DaCompany Report #2003114527 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zoloft (Sertraline) PS ORAL 100 MG Initial or Prolonged Convulsion Health (DAILY), ORAL Other Disorientation Professional Olanzapine Muscle Twitching (Olanzapine) SS ORAL 10 MG Psychomotor Agitation (DAILY), ORAL Rhabdomyolysis Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL 75 (DAILY), ORAL Lorazepam (Lorazepam) C Diazepam (Diazepam) C Date:11/05/03ISR Number: 4228764-0Report Type:Expedited (15-DaCompany Report #JP_031002041 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Foreign Zyprexa-Oral Initial or Prolonged C-Reactive Protein Health (Olanzapine) Other Chromaturia Professional (Olanzapine) PS 300 MG/1 DAY Coma Company Paxil (Paroxetine Hepatic Function Abnormal Representative Hydrochloride) C Sputum Discoloured Other Suicide Attempt Date:11/05/03ISR Number: 4228766-4Report Type:Expedited (15-DaCompany Report #GBS031013916 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Depakote (Valproate Other Semisodium) C Date:11/05/03ISR Number: 4228768-8Report Type:Expedited (15-DaCompany Report #GBS031013793 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Multiforme Foreign Zyprexa-Oral Neutropenia Health (Olanzapine) Treatment Noncompliance Professional (Olanzapine) PS 20 MG/DAY White Blood Cell Count Other Venlafaxine C Carbamazepine C Clopixol Acuphase 24-Jun-2005 12:19 PM Page: 2537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zuclopenthixol Acetate) C Date:11/05/03ISR Number: 4228769-XReport Type:Expedited (15-DaCompany Report #GBS031013882 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Olanzapine-Oral Initial or Prolonged Coordination Abnormal Health (Olanzapine) PS ORAL 15 MG/1 DAY Disability Muscle Rigidity Professional Metoclopramide C Other Pancytopenia Other Ritonavir C Somnolence Lamivudine C Azithromycin C Fluconazole C Methadone C Lansoprazole C Lactulose C Thiamine C Tenofovir Disoproxil Fumarate C Fosamprenavir C Date:11/05/03ISR Number: 4228771-8Report Type:Expedited (15-DaCompany Report #EWC031036699 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa-Oral Other Acidosis Health (Olanzapine) Agitation Professional (Olanzapine) PS 5 MG/DAY Chronic Myeloid Leukaemia Company Levosupiride C Coma Representative Difosfonal Condition Aggravated Other (Clodronate Confusional State Disodium) C Disseminated Calcium C Intravascular Coagulation Steroids C Drug Interaction Fibrin D Dimer Increased Leukaemia Recurrent Platelet Count Pulmonary Embolism Respiratory Failure Tachypnoea White Blood Cell Count Date:11/05/03ISR Number: 4228776-7Report Type:Expedited (15-DaCompany Report #CA_030806141 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basophil Count Increased Foreign Zyprexa-Oral Haematocrit Decreased Health (Olanzapine) Haemoglobin Decreased Professional (Olanzapine) PS 20 MG Petechiae Other Procyclidine C Thrombocytopenia 24-Jun-2005 12:19 PM Page: 2538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/03ISR Number: 4228783-4Report Type:Expedited (15-DaCompany Report #JP_031002049 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Study (Olanzapine) Meningitis Aseptic Health (Olanzapine) PS 10 MG/DAY Professional Mm C Other Gascon (Dimeticone) C Gluconsan K (Potassium Gluconate) C Mucosta (Rebamipide) C Magnesium Oxide C Lexotan (Bromazepam) C Doral (Quazepam) C Chinese Medicine C Gasmotin (Mosapride Citrate) C Frandol (Isosorbide Dinitrate) C Paxil (Paroxetine Hydrochloride) C Date:11/05/03ISR Number: 4228790-1Report Type:Expedited (15-DaCompany Report #JP_031002037 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa-Oral Initial or Prolonged Anxiety Literature (Olanzapine) Blood Creatine Health (Olanzapine) PS Phosphokinase Increased Professional Etizolam C Feeling Abnormal Other Levomepromazine C Hallucination, Auditory Promethazine C Hyperhidrosis Biperiden C Hypersomnia Insomnia Liver Disorder Muscle Rigidity Relationship Breakdown Restlessness Somatic Delusion Somnolence Tachycardia Tension Date:11/05/03ISR Number: 4237599-4Report Type:Expedited (15-DaCompany Report #B0313215A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Paxil (Formulation Therapeutic Literature Unknown) (Paroxetine Health Hydrochloride) PS Professional Olanzapine (Formulation Unknown) (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 2539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/03ISR Number: 4237632-XReport Type:Expedited (15-DaCompany Report #B0313227A Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Paxil (Formulation Drug Toxicity Literature Unknown) (Paroxetine Toxicologic Test Abnormal Health Hydrochloride) PS Professional Olanzapine (Formulation Unknown) (Olanzapine) SS Date:11/06/03ISR Number: 4227894-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0371291A Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Wellbutrin PS Glaxosmithkline ORAL 300MG Twice Initial or Prolonged Confusional State per day 2 YR Other Crying Lamictal SS Glaxosmithkline ORAL Dissociation Wellbutrin SS Glaxosmithkline ORAL Drooling Pain Medication SS ORAL Drug Ineffective Wellbutrin SS Glaxosmithkline ORAL 600MG per day Dysgeusia Ultracet SS Dyskinesia Seroquel SS ORAL Emotional Disorder Nicotine Gum SS Glaxosmithkline ORAL Excoriation Zyprexa SS ORAL Feeling Jittery Klonopin C ORAL Gastric Disorder Lorazepam C Grand Mal Convulsion Ortho Tri-Cyclen C ORAL Head Injury Nicotine Patch C Glaxosmithkline TRANSDERMAL Insomnia Effexor C Mania Lescol C Musculoskeletal Stiffness Nail Disorder Nausea Pain Prescribed Overdose Psoriasis Road Traffic Accident Scratch Thinking Abnormal Tooth Loss Vaginal Infection Vaginal Mycosis Vomiting Weight Decreased Weight Increased Date:11/06/03ISR Number: 4229601-0Report Type:Periodic Company Report #USA030740995 Age:41 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Dreams Initial or Prolonged Blood Glucose Decreased Other Convulsion Dental Caries Diabetes Mellitus Hallucination Hallucination, Auditory Injury 24-Jun-2005 12:19 PM Page: 2540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Libido Increased Prescribed Overdose Psychomotor Hyperactivity Report Source Product Role Manufacturer Route Dose Duration Road Traffic Accident Consumer Zyprexa- Skin Atrophy Oral (Olanzapine) PS 30 MG/AT Skin Striae BEDTIME Suicidal Ideation Prozac-Oral Weight Decreased (Fluoxetine)(Fluoxet Weight Increased ine Hydrochloride) SS 20 MG/2 DAY Tegretol(Carbamazepi ne) C Date:11/06/03ISR Number: 4229788-XReport Type:Expedited (15-DaCompany Report #AU_03036126 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Olanzapine-Oral Initial or Prolonged Cerebral Atrophy Literature (Olanzapine) PS 10 MG/DAY Other Cognitive Disorder Health Anticoagulant C Convulsion Professional Dystonia Other Electroencephalogram Abnormal Hypersomnia Hypotension Memory Impairment Myoclonus Nuclear Magnetic Resonance Imaging Brain Abnormal Sluggishness Social Avoidant Behaviour Tremor Date:11/06/03ISR Number: 4229796-9Report Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:F Outcome PT Life-Threatening Anxiety Hospitalization - Coma Initial or Prolonged Crackles Lung Other Decreased Appetite Depressed Level Of Consciousness Diabetic Coma Diabetic Ketoacidosis Dialysis Hyperventilation Hypotension Malaise Metabolic Acidosis Nausea Obesity Polydipsia Renal Failure Acute Respiratory Disorder Tachycardia Tachypnoea Thirst 24-Jun-2005 12:19 PM Page: 2541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Serenace(Haloperidol Representative 0 C Other Date:11/06/03ISR Number: 4229800-8Report Type:Expedited (15-DaCompany Report #JP_030901726 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Q Wave Foreign Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine) Disability Malaise Professional (Olanzapine) PS 10 MG/DAY Pyrexia Company Serenace(Haloperidol Respiratory Failure Representative ) C White Blood Cell Count Other Depas(Etizolam) C Increased Artrane(Trihexypheni dyl Hydrochloride) C Contomin(Chlorpromaz ine Hydrochloride) C Pursennide(Senna Leaf) C Date:11/06/03ISR Number: 4229852-5Report Type:Expedited (15-DaCompany Report #JP_030901812 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chemical Poisoning Foreign Zyprexa-Oral Completed Suicide Study (Olanzapine) Health (Olanzapine) PS 10 MG/DAY Professional Lexotan(Bromazepam) C Other Tetramide(Mianserin Hydrochloride) C Halcion(Triazolam) C Amoxan(Amoxapine) C Date:11/06/03ISR Number: 4229856-2Report Type:Expedited (15-DaCompany Report #EWC031036662 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Withdrawal Syndrome Health (Olanzapine) PS 10 MG/DAY Urinary Tract Infection Professional Lorazepam C Other Valerian Extract C Chloral Hydrate C Atenolol C Esomeprazole C Chondroitin Sulfate C Mianserin C Clotiapine C Reboxetine C 24-Jun-2005 12:19 PM Page: 2542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/03ISR Number: 4229905-1Report Type:Expedited (15-DaCompany Report #EWC031036524 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Injury Asphyxiation Health (Olanzapine) PS Professional Citalopram C Company Moditen(Fluphenazine Representative Hydrochloride) C Other Akineton(Biperiden Hydrochloride) C Dormicum(Nitrazepam) C Amlopin(Amlodipine Besilate) C Date:11/06/03ISR Number: 4229914-2Report Type:Expedited (15-DaCompany Report #EWC030936271 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG/DAY 6 WK Professional Risperidone C Company Paracetamol C Representative Other Date:11/06/03ISR Number: 4229918-XReport Type:Expedited (15-DaCompany Report #EWC030534815 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Zyprexa-Oral Breast Hyperplasia Health (Olanzapine) Breast Mass Professional (Olanzapine) PS 20 MG/DAY Breast Pain Company Paroxetine C Weight Increased Representative Other Date:11/06/03ISR Number: 4230464-8Report Type:Expedited (15-DaCompany Report #JP_031001997 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Study (Olanzapine) Other Aspartate Health (Olanzapine) PS 5MG/DAY Aminotransferase Professional Hirnamin(Levomeproma Increased Other zine) C Blood Creatine Rivotril(Clonazepam) C Phosphokinase Increased Trihexyphenidyl Dyskinesia Hydrochloride C Insomnia Neurovitan C Medication Error Gramalil(Tiapride Pneumonia Aspiration Hydrochloride) C Rohypnol(Flunitrazep am) C Tinelac(Sennoside A+B) C 24-Jun-2005 12:19 PM Page: 2543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/03ISR Number: 4230474-0Report Type:Expedited (15-DaCompany Report #USA031049295 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Health Strattera Initial or Prolonged Aggression Professional (Atomoxetine Aphasia Company Hydrochloride) PS 18 MG/DAY 2 DAY Cerebrovascular Accident Representative Zyprexa-Oral Convulsion (Olanzapine) Heart Rate Increased (Olanzapine) SS 2.5 MG/DAY Hemiparesis Clonidine C Respiratory Disorder Metadate Staring (Methylphenidate) C Tic Date:11/06/03ISR Number: 4230675-1Report Type:Periodic Company Report #US_021189641 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Prozac Weekly PS 90 MG/DAY Initial or Prolonged Limb Injury Professional Zypexa-Oral Prescribed Overdose (Olanzapine) Pulmonary Embolism (Olanzapine) SS 50 MG/DAY Tricor (Fenofibrate) C Premarin (Estrogens Conjugated) C Vitamin E C Date:11/06/03ISR Number: 4230676-3Report Type:Periodic Company Report #US_021189647 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Prozac-Oral Initial or Prolonged Cataract Other (Fluoxetine) Depression (Fluoxetine Dizziness Hydrochloride) PS Hand Fracture Humulin-Human Osteoporosis Insulin (Rdna) :30% Rib Fracture Regular, 70% Nph SS 48 IU/2 DAY Somnolence Zyprexa-Oral Suicidal Ideation (Olanzapine) SS 15 MG/DAY Actos (Pioglitazone) C Takeda Anacin C Celebrex (Celecoxib) C Salsalate C Depakote (Valproate Semisodium) C Risperdal (Riseperidone) C Nitroglycerin (Glyceryl Trinitrate) C 24-Jun-2005 12:19 PM Page: 2544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/03ISR Number: 4230695-7Report Type:Periodic Company Report #USA020718078 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Health Prozac-Oral Initial or Prolonged Sedation Professional (Fluoxetine) Company (Fluoxetine Representative Hydrochloride) PS 40 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 30 MG/DAY Valproic Acid C Clozaril (Clozapine) C Date:11/06/03ISR Number: 4230700-8Report Type:Periodic Company Report #USA030845778 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS ORAL 60 MG/DAY Prescribed Overdose Professional Prozac (Fluoxetine Hydrochloride) SS OROPHARINGEAL 30 MG/DAY Xanax (Alprazolam) C Neurontin (Gabapentin) C Fluoxetine C Norfluoxetiine C Date:11/06/03ISR Number: 4230701-XReport Type:Periodic Company Report #USA030844908 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Prozac PS Initial or Prolonged Respiratory Depression Professional Zyprexa-Oral Somnolence (Olanzapine)(Olanzap ine) SS Date:11/06/03ISR Number: 4230706-9Report Type:Periodic Company Report #USA030742301 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Prozac Initial or Prolonged Anxiety (Fluoxetine Convulsion Hydrochloride) PS 60 MG/1 IN Obsessive-Compulsive THE MORNING Disorder Zyprexa-Oral (Olanzapine)(Olanzap ine) SS 17.5 MG/DAY Klonopin (Clonazepam) C Topamax(Topiramate) C Contraceptive Pill(Oral Contraceptive Nos) C 24-Jun-2005 12:19 PM Page: 2545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4231635-7Report Type:Direct Company Report #CTU 205541 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Zyprexa 61/2 Yrs. Abdominal Pain Consistantly From Abnormal Behaviour 12/3/01-10/15/03. Confusional State Dose Mostly Hyperglycaemia 7.5mg/Day PS Hyperglycaemic Seroquel Hyperosmolar Nonketotic 1/12/00->10/15/2003 Syndrome Dose Mostly 400 Mg Nausea Sqd SS Pancreatitis Paxil Polydipsia 9/98->10/15//03 Dose Vomiting 60 Mg Qd Last 10 Days SS Trazodone 50 Mg One @Hs Since 8/12/03 SS Date:11/07/03ISR Number: 4232064-2Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0313072A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Deroxat PS Glaxosmithkline ORAL Zyprexa SS UNKNOWN Date:11/09/03ISR Number: 4232883-2Report Type:Direct Company Report #CTU 205701 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa 15mg Lilly PS Lilly ORAL 2 TABLETS BID Disability Diabetic Neuropathy ORAL Required General Physical Health Seroquel 100mg Intervention to Deterioration Astrazeneca SS Astrazeneca ORAL 1 TABLET ONCE Prevent Permanent Hypertension DAILY ORAL Impairment/Damage Ketoacidosis Effexor C Proteinuria Synthroid C Buspar C Albuterol C Date:11/10/03ISR Number: 4232398-1Report Type:Direct Company Report #CTU 205690 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Olanzapine 5 Mg Eli Intervention to Diabetes Mellitus Lilly PS Eli Lilly ORAL 15 MG QHS Prevent Permanent Drug Effect Decreased ORAL Impairment/Damage Suicidal Ideation Olanzapine 5 Mg Eli Lilly SS Eli Lilly ORAL 5 MG QAM ORAL Effexor C Geodon C Xanax C Paxil C 24-Jun-2005 12:19 PM Page: 2546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/03ISR Number: 4234148-1Report Type:Expedited (15-DaCompany Report #2003-109712-NL Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Mirtazapine PS ORAL 30 MG, ORAL Olanzapine SS ORAL 2.5 MG, ORAL 6 WK Date:11/12/03ISR Number: 4233921-3Report Type:Direct Company Report #CTU 205852 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Olanzapine 10 Mg Initial or Prolonged Phosphokinase Increased Lilly PS Lilly 10 MG AM AND HS Date:11/12/03ISR Number: 4234811-2Report Type:Expedited (15-DaCompany Report #USA030844300 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa-Oral Feeling Abnormal Professional (Olanzapine) Haematoma Company (Olanzapine) PS 5 MG/DAY Representative Date:11/12/03ISR Number: 4234986-5Report Type:Expedited (15-DaCompany Report #EWC031036699 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Foreign Zyprexa PS 5 MG/DAY Hospitalization - Agitation Health Levosulpiride C Initial or Prolonged Anaemia Professional Difosfonal Other Anorexia Company (Clodronate Coma Representative Disodium) C Confusional State Other Calcium C Disseminated Steroids C Intravascular Coagulation Drug Interaction Fibrin D Dimer Increased Leukaemia Recurrent Platelet Count Pulmonary Embolism Respiratory Failure Tachypnoea Treatment Noncompliance White Blood Cell Count Date:11/12/03ISR Number: 4235038-0Report Type:Expedited (15-DaCompany Report #JP_031001997 Age:66 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Other Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Dyskinesia 24-Jun-2005 12:19 PM Page: 2547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Pneumonia Aspiration Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 5 MG/DAY Professional Hirnamin Other (Levomepromazine) C Rivotril (Clonazepam) C Trihexyphenidyl Hydrochloride C Neurovitan C Gramalil (Tiapride Hydrochloride) C Rohypnol (Flunitrazepam) C Tinelac (Sennoside A+B) C Date:11/12/03ISR Number: 4235039-2Report Type:Expedited (15-DaCompany Report #GBS030913711 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Olanzapine-Oral Hospitalisation Health (Olanzapine) PS 20 MG 6 MON Pulmonary Embolism Professional Haloperidol C Company Representative Other Date:11/12/03ISR Number: 4235132-4Report Type:Expedited (15-DaCompany Report #NLWYE381103NOV03 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Health Efexor Xr Drug Interaction Professional (Venlafaxine Serotonin Syndrome Hydrochloride, Suicidal Ideation Capsule, Extended Release, 0) PS ORAL 75 MG 1X PER 1 DAY ORAL Zyprexa (Olanzapine, , 0) SS 7.5 MG 1X PER 1 DAY Date:11/12/03ISR Number: 4235266-4Report Type:Expedited (15-DaCompany Report #JP_030901826 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Other Parkinsonism Health (Olanzapine)(Olanzap Professional ine) PS 10 MG/DAY Company Valerin (Valproate Representative Sodium) C Other Depas (Etizolam) C Luvox (Fluvoxamine Maleate) C Silece 24-Jun-2005 12:19 PM Page: 2548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Flunitrazepam) C Lendormin (Brotizolam) C Diazepam C Sennoside A+B C Date:11/12/03ISR Number: 4235267-6Report Type:Expedited (15-DaCompany Report #JP_030801507 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Foreign Zyprexa-Oral Hospitalization - Constipation Health (Olanzapine) PS 2.5 MG/DAY Initial or Prolonged Hypercapnia Professional Wintermin Respiratory Depression Company (Chlorpromazine Respiratory Failure Representative Hydrochloride) C Other Gaster (Famotidine) C Primperan (Metoclopramide) C Bisolvon (Bromhexine Hydrochloride) C Ciproxan (Ciprofloxacin Hydrochloride) C Rohypnol (Flunitrazepam) C Serenace (Haloperidol) C Lasix (Furosemide) C Selbex (Teprenone) C Mucosolvan (Ambroxol Hydrochloride) C Date:11/12/03ISR Number: 4235268-8Report Type:Expedited (15-DaCompany Report #FR_030702648 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Oral Initial or Prolonged Biopsy Bone Marrow Health (Olanzapine) Abnormal Professional (Olanzapine) PS 5 MG/DAY Hyponatraemia Other Mepronizine C Malaise Gabacet (Piracetam) C Pyrexia Tegretol Renal Failure (Carbamazepine) C Syncope Seresta (Oxazepam) C Stilnox (Zolpidem) C Mediator (Benfluorex Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Athymil (Mianserin Hydrochloride) C Aranax (Naproxen Sodium) C Lanzor (Lansoprazole) C 24-Jun-2005 12:19 PM Page: 2549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/03ISR Number: 4235269-XReport Type:Expedited (15-DaCompany Report #FR_030702727 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Foreign Zyprexa-Oral Prescribed Overdose Health (Olanzapine) Respiratory Disorder Professional (Olanzapine) PS 30 MG/DAY Urticaria Other Depakine Chrono C Effexor (Venlafaxine Hydrochloride C Seresta (Oxazepam) C Lepticur (Tropatepine Hydrochloride) C Diane C Theralene (Alimemazine Tartrate) C Date:11/13/03ISR Number: 4234377-7Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0314609A Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Paroxetine PS Glaxosmithkline ORAL 40MG per day Initial or Prolonged Multiple Drug Overdose Olanzapine SS ORAL 15MG per day Diazepam SS UNKNOWN Date:11/13/03ISR Number: 4235768-0Report Type:Expedited (15-DaCompany Report #USA030947745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa-Oral Professional (Olanzapine ) Company (Olanzapine) PS 10 MG Representative Depakote (Valproate Semisodium) C Date:11/13/03ISR Number: 4235775-8Report Type:Expedited (15-DaCompany Report #USA031050801 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Paxil (Paroxetine Hydrochloride) C Date:11/13/03ISR Number: 4235902-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706436 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Bones Fracture Foreign Risperdal Grand Mal Convulsion Health (Risperidone) Skin Laceration Professional Tablets PS ORAL 6 MG, ORAL Leponex (Clozapine) Tablets SS ORAL 25 MG, ORAL Zyprexa (Olanzapine) Tablets SS ORAL 20 MG, ORAL 24-Jun-2005 12:19 PM Page: 2550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cipramil (Citalopram Hydrobromide) Tablets SS ORAL 20 MG, ORAL Bronchoretard (Theophylline) C Berotec (Fenoterol Hydrobromide) Spray C Pulmicort (Budesonide) Spray C Date:11/13/03ISR Number: 4235944-7Report Type:Expedited (15-DaCompany Report #AU_031006849 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Foreign Zyprexa-Oral Initial or Prolonged Neonatal Health (Olanzapine) Congenital Anomaly Congenital Foot Professional (Olanzapine) PS Other Malformation Other Epilim (Valproate Convulsion Neonatal Sodium) C Feeding Problem In Clozaril (Clozapine) C Newborn Zuclopenthixol Hepatosplenomegaly Decanoate C Hyperammonaemia Hyperbilirubinaemia Neonatal Apnoeic Attack Pregnancy Vomiting Weight Decreased Date:11/13/03ISR Number: 4235949-6Report Type:Expedited (15-DaCompany Report #AU_031006851 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Foreign Olanzapine-Oral Initial or Prolonged Imbalance Health (Olanzapine) PS 30 MG/DAY Professional Haloperidol C Other Date:11/13/03ISR Number: 4235951-4Report Type:Expedited (15-DaCompany Report #AU_031006858 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zyprexa-Oral Consciousness Health (Olanzapine) Hyponatraemia Professional (Olanzapine) PS 20 MG/DAY Muscle Rigidity Other Diazepam C Rhabdomyolysis Urine Osmolarity Date:11/13/03ISR Number: 4235952-6Report Type:Expedited (15-DaCompany Report #DE_031012270 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Life-Threatening Constipation Foreign Hospitalization - Health Initial or Prolonged Professional Company 24-Jun-2005 12:19 PM Page: 2551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/DAY Haloperidol C Date:11/13/03ISR Number: 4235953-8Report Type:Expedited (15-DaCompany Report #EWC031036737 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Hospitalization - Haemorrhage Health (Olanzapine) Initial or Prolonged Polytraumatism Professional (Olanzapine) PS 40 MG/DAY Syncope Company Quilnorm(Lithium Representative Acetate) C Other Lamictal (Lamotrigine) C Date:11/13/03ISR Number: 4235954-XReport Type:Expedited (15-DaCompany Report #EWC031036760 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Olanzapine-Oral Initial or Prolonged Aminotransferase Health (Olanzapine) PS 30 MG/DAY Increased Professional Diazepam C Blood Creatinine Other Zopiclone C Increased Levomepromazine C Blood Glucose Increased Mirtazapine C Blood Lactate Acetylsalicylic Acid C Dehydrogenase Increased Metoprolol C C-Reactive Protein Atenolol C Increased Enalapril C Rhabdomyolysis Salvia C Weight Decreased Chlorprothixen "Neuraxpharm" (Chlorprothixene Hydrochloride) C Flupentixol C Biperiden C Date:11/13/03ISR Number: 4235955-1Report Type:Expedited (15-DaCompany Report #EWC031036774 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Interaction Health (Olanzapine) PS 7.5 MG/DAY Libido Increased Professional Remeron Other (Mirtazapine) C Date:11/13/03ISR Number: 4235969-1Report Type:Expedited (15-DaCompany Report #EWC031036780 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Diabetic Hyperglycaemic Initial or Prolonged Coma 24-Jun-2005 12:19 PM Page: 2552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Enzyme Increased Influenza Myalgia Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Zyprexa -Oral Renal Failure Health (Olanzapine) PS 10 MG/ DAY Professional Depakin (Valproate Company Sodium) C Representative Orap (Pimozide) C Other Tavor (Lorazepam) C Date:11/13/03ISR Number: 4235980-0Report Type:Expedited (15-DaCompany Report #FR_031003067 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Company Symbicort C Representative Other Date:11/13/03ISR Number: 4235981-2Report Type:Expedited (15-DaCompany Report #GBS031013959 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Olanzapine-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) PS 10 MG Other Confusional State Professional Zopiclone C Psychotic Disorder Other Adcal-D3 C Water Intoxication Diazepam C Carbimazole C Date:11/13/03ISR Number: 4235982-4Report Type:Expedited (15-DaCompany Report #JP_031002099 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Persecutory Delusion Study (Olanzapine) Schizophrenia, Paranoid Health (Olanzapine) PS 10 MG/DAY Type Professional Lexin Other (Carbamazepine) C Hiberna (Promethazine Hydrochloride) C Barnetil (Sultopride) C Rohypnol (Flunitrazepam) C Bicamol (Biperiden Hydrochloride) C Midodrine Hydrochloride C Amezinium Metilsulfate C Gasmotin (Mosapride Citrate) C Pantosin (Pantethine) C 24-Jun-2005 12:19 PM Page: 2553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Magnesium Oxide C Sennoside A+B C Halomonth (Haloperidol Decanoate) C Date:11/13/03ISR Number: 4235983-6Report Type:Expedited (15-DaCompany Report #JP_031002075 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Study (Olanzapine) Blood Creatine Health (Olanzapine) PS 5 MG/DAY Phosphokinase Increased Professional Risperdal Dehydration Other (Risperidone) C Hypernatraemia Wypax (Lorazepam) C Pyrexia Akineton (Biperiden Rhabdomyolysis Hydrochloride) C Selbex (Teprenone) C Vegetamin A C Depas (Etizolam) C Rohypnol (Flunitrazepam) C Parlodel (Bromocriptine Mesilate) C Ubretid (Distigmine Bromide) C Melleril (Thioridazine Hydrochloride) C Date:11/13/03ISR Number: 4235984-8Report Type:Expedited (15-DaCompany Report #JP_031002058 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diet Refusal Foreign Zyprexa-Oral Other Hypokalaemia Study (Olanzapine) Smoker Health (Olanzapine) PS 10 MG/1 DAY Suicide Attempt Professional Risperdal Weight Decreased (Risperidone) C Dogmatyl (Supiride) C Pyrethia (Promethazine Hydrochloride) C Risumic (Amezinium Metilsulfate) C Metligine (Midordrine Hydrochloride) C Benzalin (Nitrazepam) C Laxoberon (Sodium Picosulfate) C 24-Jun-2005 12:19 PM Page: 2554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/03ISR Number: 4236531-7Report Type:Direct Company Report #CTU 206176 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Zyprexa Initial or Prolonged Decreased (Olanzapine)/Lilly PS Lilly ORAL 2.5 MG PO Q HS Methylprednisolone C Date:11/17/03ISR Number: 4237088-7Report Type:Expedited (15-DaCompany Report #2003040700 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bipolar I Disorder Foreign Lipitor Hospitalization - Seasonal Affective Consumer (Atorvastatin) PS ORAL 20 MG Initial or Prolonged Disorder Health (DAILY), ORAL Other Sleep Disorder Professional Olanzapine Suicide Attempt (Olanzapine) SS 5 MG (DAILY) Lithium (Lithium Carbonate) (Lithium) SS 100 MG (DAILY) Date:11/18/03ISR Number: 4237618-5Report Type:Expedited (15-DaCompany Report #2003003832 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Lithium (Lithium) PS ORAL 600 MG (BID), Initial or Prolonged Anion Gap Increased Professional ORAL Anxiety Olanzapine Bleeding Time Prolonged (Olanzapine) SS ORAL 20 MG, ORAL Blood Alkaline Atenolol (Atenolol) C Phosphatase Increased Lorazepam Blood Bicarbonate (Lorazepam) C Decreased Blood Calcium Decreased Blood Glucose Increased Blood Potassium Increased Blood Sodium Decreased Blood Thyroid Stimulating Hormone Increased Confusional State Depression Disturbance In Attention Dysarthria Gait Disturbance Haematocrit Decreased Haemoglobin Decreased Hypertension Lymphocyte Percentage Decreased Mean Platelet Volume Decreased Neutrophil Percentage Increased Red Blood Cell Count Decreased Renal Failure Acute Schizoaffective Disorder Therapeutic Agent Toxicity 24-Jun-2005 12:19 PM Page: 2555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4237439-3Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0379981A Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Ethanol Increased Consumer Bupropion PS Glaxosmithkline ORAL Cardiomegaly Carbamazepine SS UNKNOWN Coma Olanzapine SS UNKNOWN Completed Suicide Clonazepam SS Convulsion Ethanol SS Depressed Level Of Aspirin SS Glaxosmithkline Consciousness Ecchymosis Hepatic Steatosis Intentional Misuse Mydriasis Ovarian Cyst Pulmonary Congestion Pulmonary Oedema Pupil Fixed Date:11/19/03ISR Number: 4238625-9Report Type:Expedited (15-DaCompany Report #JP_030801654 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa-Oral Initial or Prolonged Consciousness Study (Olanzapine) Hypochloraemia Health (Olanzapine) PS 10 MG/DAY Hyponatraemia Professional Lullan (Perospirone Other Hydrochloride) C Depas (Etizolam) C Setous (Zotepine) C Benzalin (Nitrazepam) C Isomytal (Amobarbital) C Brovarin (Bromisoval) C Picoben (Sodium Picosulfate) C Date:11/19/03ISR Number: 4238627-2Report Type:Expedited (15-DaCompany Report #JP_030500916 Age:51 YR Gender:Male I/FU:F Outcome PT Death Abdominal Distension Abdominal Pain Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Bilirubin Increased Blood Lactate Dehydrogenase Increased Condition Aggravated Decreased Appetite Feeling Abnormal Gamma-Glutamyltransferase Increased Hepatic Cancer Metastatic 24-Jun-2005 12:19 PM Page: 2556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatomegaly Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) PS 15 MG/DAY Professional Tegretol Company (Carbamazepine) C Representative Other Date:11/19/03ISR Number: 4238631-4Report Type:Expedited (15-DaCompany Report #EWC031036780 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Hepatic Enzyme Increased Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS 15 MG/DAY Influenza Company Tavor (Lorazepam) C Ketoacidosis Representative Carbamazepine C Myalgia Other Pyrexia Renal Failure Date:11/19/03ISR Number: 4238633-8Report Type:Expedited (15-DaCompany Report #EWC030735521 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Foreign Olanzapine-Dispersib Initial or Prolonged Pancytopenia Health le (Olanzapine) PS 20 MG/DAY Professional Valium (Diazepam) C Other Date:11/19/03ISR Number: 4238634-XReport Type:Expedited (15-DaCompany Report #DE_030511317 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Foreign Zyprexa Velotab-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 10 MG IN THE Other EVENING Date:11/19/03ISR Number: 4238797-6Report Type:Expedited (15-DaCompany Report #USA031050393 Age:24 YR Gender:Male I/FU:F Outcome PT Death Abasia Hospitalization - Abdominal Pain Initial or Prolonged Blood Triglycerides Increased Confusional State Hyperglycaemia Hyperosmolar State Nausea Pancreatic Enlargement Pancreatitis Polydipsia Polyuria 24-Jun-2005 12:19 PM Page: 2557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Refusal Of Treatment By Patient Vomiting Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa-Oral Increased Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Seroquel (Quetiapine Fumarate) C Paxil (Paroxetine Hydrochloride) C Trazodone C Date:11/19/03ISR Number: 4238799-XReport Type:Expedited (15-DaCompany Report #USA031049093 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Health Zyprexa-Oral Initial or Prolonged Complications Of Maternal Professional (Olanzapine) Exposure To Therapeutic (Olanzapine) PS 20 MG/1 AT Drugs BEDTIME Diarrhoea Prozac-Oral Enuresis (Fluoxetine) Intentional Self-Injury (Fluoxetine Laceration Hydrochloride) SS 60 MG/DAY Scab Klonopin Treatment Noncompliance (Clonazepam) C Weight Increased Ibuprofen C Acetaminophen C Magnesium Hydroxide C Aluminum/Magnesium/S imeth C Cetylpyridinium Chloride C Lopedium (Loperamide Hydrochloride) C Multivitamin C Date:11/19/03ISR Number: 4238987-2Report Type:Expedited (15-DaCompany Report #2003-03756 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Dilacor Xr (Watson Health Laboratories)(Diltia Professional zem Hydrochloride) Capsule (Extended Release) PS Watson Laboratories ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Date:11/19/03ISR Number: 4239059-3Report Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:F Outcome PT Life-Threatening Aspartate Hospitalization - Aminotransferase Initial or Prolonged Increased Blood Lactate Dehydrogenase Increased 24-Jun-2005 12:19 PM Page: 2558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urea Increased Condition Aggravated Dialysis Report Source Product Role Manufacturer Route Dose Duration Pulmonary Oedema Foreign Zyprexa Renal Impairment Health (Olanzapine) PS 10 MG/DAY Respiratory Failure Professional Amoban (Zopiclone) C Rhabdomyolysis Company Cercine (Diazepam) C Representative Cefazolin Sodium C Other Cravit (Levofloxacin) C Perdipin La (Nicardipine Hydrochloride) C Heparin C Lasix (Furosemide) C Mannitol C Epogin (Epoetin Beta) C Date:11/19/03ISR Number: 4239061-1Report Type:Expedited (15-DaCompany Report #JP_030901706 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa Increased Health (Olanzapine) PS ORAL 15 MG/DAY Aspartate Professional Sennoside A+B SS Aminotransferase Company Carbamazepine C Increased Representative Silece Dizziness Other (Flunitrazepam) C Hyponatraemia Doral (Quazepam) C Polydipsia Polyuria Pyrexia Rectal Prolapse Rhabdomyolysis Date:11/19/03ISR Number: 4239174-4Report Type:Expedited (15-DaCompany Report #2003040180 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Nardil (Phenelzine Initial or Prolonged Anxiety Sulfate) PS ORAL 30 MG Disability Difficulty In Walking (DAILY), ORAL Other Fatigue Olanzapine Glucose Tolerance (Olanzapine) SS ORAL 10 MG Impaired (DAILY), ORAL Hypersomnia Clonazepam Hypertonia (Clonazepam) SS 2 MG (DAILY) Impaired Work Ability Clozapine Muscle Rigidity (Clozapine) SS Muscle Spasms Rosiglitazone Muscle Strain Maleate Muscle Tightness (Rosiglitazone Myalgia Maleate) C Myocardial Infarction Tamsulosin Panic Disorder Hydrochloride (Tamsulosin Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4239407-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102715 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Study Risperidone Weight Increased Health (Risperidone) Professional Unspecified PS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Ziprasidone (Ziprasidone) SS Perphenazine (Perphenazine) SS Date:11/19/03ISR Number: 4239548-1Report Type:Expedited (15-DaCompany Report #2003-03807 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Metformin Health Hydrochloride Professional (Watson Laboratories) (Metformin PS Watson Laboratories Quetiapine (Quetiapine) SS Olazapine(Olanzapine ) SS Date:11/20/03ISR Number: 4238031-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0379986A Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Bupropion PS Glaxosmithkline ORAL Cardiac Arrest Olanzapine SS UNKNOWN Completed Suicide Clonazepam SS UNKNOWN Convulsion Aspirin SS Glaxosmithkline Gastrointestinal Motility Acetaminophen SS Glaxosmithkline Disorder Sertraline SS Hypokinesia Trazodone SS Hypotension Ibuprofen SS Glaxosmithkline Intentional Misuse Mental Status Changes Overdose Pupillary Reflex Impaired Ventricular Fibrillation Date:11/20/03ISR Number: 4238034-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0379990A Age:46 YR Gender: I/FU:F Outcome PT Death Blood Pressure Decreased Cardio-Respiratory Arrest Coma Completed Suicide Cyanosis Depressed Level Of Consciousness 24-Jun-2005 12:19 PM Page: 2560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Intentional Misuse Miosis Report Source Product Role Manufacturer Route Dose Duration Oxygen Saturation Bupropion PS Glaxosmithkline ORAL Decreased Alprazolam SS UNKNOWN Respiratory Rate Olanzapine SS UNKNOWN Increased Gabapentin SS Cyanide SS Date:11/20/03ISR Number: 4238045-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383146A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Bupropion PS Glaxosmithkline ORAL Completed Suicide Olanzapine SS UNKNOWN Intentional Misuse Loss Of Consciousness Date:11/20/03ISR Number: 4239523-7Report Type:Expedited (15-DaCompany Report #2003-03829 Age:54 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Clonazepam(Watson Health Laboratories)(Clonaz Professional epam)Tablet PS Watson Laboratories Sertraline(Sertralin e) SS Olanzapine(Olanzapin e) SS Date:11/24/03ISR Number: 4240363-3Report Type:Direct Company Report #CTU 206661 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Olanzapine 2.5 Mg PS ORAL 2.5 MG QHS Intervention to ORAL Prevent Permanent Simvastatin C Impairment/Damage Lisinopril C Venlafaxine Hcl C Bisacodyl C Glipizide C Albuterol C Methadone C Docusate Na C Hydrocortisone 1% Cream C Metformin C Date:11/24/03ISR Number: 4240484-5Report Type:Direct Company Report #CTU 206705 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Olanzapine Tablets PS Lilly ORAL 10 MG PO Hospitalization - TWICE DAILY Initial or Prolonged Divalproex Er SS Abbott 50MG BEDTIME 24-Jun-2005 12:19 PM Page: 2561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4240908-3Report Type:Direct Company Report #CTU 206755 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Zyprexia PS 10 MG QD -> Hospitalization - Increased 7.5 MG QD-> Initial or Prolonged Blood Culture Positive 2.5 MG QD Blood Potassium Increased [HOME MED] Encephalopathy Lithium C Escherichia Infection Verapamil C Escherichia Urinary Tract Bupropion C Infection Atrovent C Fatigue Lethargy Neuroleptic Malignant Syndrome Pneumonia Staphylococcal Infection Urinary Tract Infection Date:11/24/03ISR Number: 4241146-0Report Type:Expedited (15-DaCompany Report #2003-03908 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Trazodone Health Hydrochloride Professional (Watson Laboratories) (Trazodone PS Olanzapine (Olanzapine) SS Date:11/24/03ISR Number: 4241155-1Report Type:Expedited (15-DaCompany Report #2003-03909 Age:51 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Trazodone Health Hydrochloride Professional (Watson Laboratories) (Trazodone PS Carbamazepine(Carbam azepine) SS Olanzapine(Olanzapin e) SS Date:11/24/03ISR Number: 4241695-5Report Type:Expedited (15-DaCompany Report #2003-110292-NL Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Mirtazapine PS ORAL 30 MG ORAL Literature Olanzapine SS ORAL 5 MG ORAL 4 MON Health Lorazepam SS ORAL 1 MG ORAL Professional Chlorpromazine Other Hydrochloride SS ORAL 50 MG PRN ORAL 24-Jun-2005 12:19 PM Page: 2562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241703-1Report Type:Expedited (15-DaCompany Report #2003-110298-NL Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Foreign Mirtazapine PS ORAL DF ORAL Pneumonia Literature Olanzapine SS ORAL 10 MG ORAL Health Prazosin Professional Hydrochloride C Other Oxazepam C Senna Fruit C Temazepam C Paracetamol C Date:11/25/03ISR Number: 4240741-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383134A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Bupropion PS Glaxosmithkline ORAL Cardio-Respiratory Arrest Valproic Acid SS UNKNOWN Coma Olanzapine SS UNKNOWN Completed Suicide Convulsion Depressed Level Of Consciousness Electroencephalogram Abnormal Heart Rate Increased Intentional Misuse Pyrexia Date:11/25/03ISR Number: 4240743-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383142A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Bupropion PS Glaxosmithkline ORAL 30TAB Single Coma dose Completed Suicide Aspirin SS Glaxosmithkline UNKNOWN Confusional State Olanzapine SS UNKNOWN 40TAB Single Intentional Misuse dose Multiple Drug Overdose Postictal State Pyrexia Tachycardia Date:11/25/03ISR Number: 4241062-4Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12434601 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Zerit Caps 15 Mg PS Bristol-Myers Squibb Pancytopenia Professional Company ORAL Pyrexia Videx Tabs 25 Mg SS Bristol-Myers Squibb Company ORAL Zyprexa SS ORAL Viread C ORAL 24-Jun-2005 12:19 PM Page: 2563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4242194-7Report Type:Expedited (15-DaCompany Report #2003-03995 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Fluoxetine (Watson Health Laboratories) Professional (Fluoxetine) Capsule PS UNKNOWN UNK, UNK, UNK Olanzapine (Olanzapine) SS UNKNOWN UNK, UNK, UNK Unknown Drug() SS UNKNOWN UNK, UNK, UNK Date:11/25/03ISR Number: 4242259-XReport Type:Expedited (15-DaCompany Report #USA031151754 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa-Oral Initial or Prolonged Fall Professional (Olanzapine) Pulmonary Embolism (Olanzapine) PS UNKNOWN UNK 1 YR Remeron (Mirtazapine) C Date:11/25/03ISR Number: 4242261-8Report Type:Expedited (15-DaCompany Report #USA031151476 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Zyprexa-Oral Increased Professional (Olanzapine) Company (Olanzapine) PS UNK Representative Aricept (Donepezil Hydrochloride) C Date:11/25/03ISR Number: 4242263-1Report Type:Expedited (15-DaCompany Report #USA031151433 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS UNKNOWN UNK Representative Date:11/25/03ISR Number: 4242278-3Report Type:Expedited (15-DaCompany Report #US_031198655 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cerebral Disorder Health Zyprexa-Oral Foetal Disorder Professional (Olanzapine) Maternal Drugs Affecting (Olanzapine) PS Foetus Prozac-Oral Microcephaly (Fluoxetine) (Fluoxetine Hydrochloride) SS Klonopin (Clonazepam) C Ibuprofen C Acetaminophen C Magnesium Hydroxide C Aluminium/Magnesium/ Simeth C 24-Jun-2005 12:19 PM Page: 2564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cetylpyridinium Chloride C Lopedium (Loperamide Hydrochloride) C Multivitamins C Date:11/25/03ISR Number: 4242280-1Report Type:Expedited (15-DaCompany Report #US_030493862 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acidosis Consumer Zyprexa-Oral Anaemia Health (Olanzapine) Bacteraemia Professional (Olanzapine) PS Bacterial Infection Zestril C Blood Culture Positive Zoloft (Sertraline Bronchitis Hydrochloride) C Coma Desyrel (Trazodone Diabetes Mellitus Hydrochloride) C Diarrhoea Vioxx (Rofecoxib) C Fungal Cystitis Lopressor Hepatic Steatosis (Metoprolol Hypernatraemia Tartrate) C Hypokalaemia Celebrex (Celecoxib) C Inflammation Combivent C Metabolic Encephalopathy Pepcid (Famotidine) C Organ Failure Ultram (Tramadol Pancreatitis Acute Hydrochloride) C Pleural Effusion Pneumonia Renal Failure Acute Respiratory Failure Sputum Culture Positive Tachycardia Thrombocytopenia Vaginal Discharge Vaginal Infection White Blood Cell Count Increased Date:11/25/03ISR Number: 4242283-7Report Type:Expedited (15-DaCompany Report #2003-04026 Age:44 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Alprazolam (Watson Health Laboratories) PS Watson Laboratories Professional Olanzapine (Olanzapine) SS Sertraline (Sertraline) SS Date:11/25/03ISR Number: 4242661-6Report Type:Expedited (15-DaCompany Report #GBS031013949 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epilepsy Foreign Olanzapine Health (Olanzapine) PS ORAL 10 MG/1 DAY Professional Cipramil (Citalopram Other Hydrobromide) C ORAL 24-Jun-2005 12:19 PM Page: 2565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amisulpride C ORAL Date:11/25/03ISR Number: 4242685-9Report Type:Expedited (15-DaCompany Report #GBS031113993 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Olanzapine-Oral Thromboplastin Time Health (Olanzapine) PS 60 MG Prolonged Professional Citalopram C Hyperkalaemia Other Potassium C Prescribed Overdose Date:11/25/03ISR Number: 4242691-4Report Type:Expedited (15-DaCompany Report #EWC031136801 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Foreign Olanzapine-Oral Hospitalization - Blood Creatinine Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Increased Professional Lithium C Blood Glucose Increased Other Fina C Coma Imovane (Zopiclone) C Date:11/25/03ISR Number: 4242692-6Report Type:Expedited (15-DaCompany Report #DE_031112312 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other B-Cell Small Lymphocytic Foreign Zyprexa-Oral Lymphoma Health (Olanzapine) Professional (Olanzapine) PS 5 MG/DAY 3 YR Other Sortis (Atorvastatin Caldium) C Blopress Plus C Date:11/25/03ISR Number: 4242693-8Report Type:Expedited (15-DaCompany Report #DE_031012294 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Damage Foreign Zyprexa-Oral Initial or Prolonged Confusional State Health (Olanzapine) Convulsion Professional (Olanzapine) PS 10 MG/DAY Disorientation Other Saroten Retard Muscle Twitching (Amitriptyline Psychomotor Agitation Hydrochloride) C Restlessness Zoloft (Sertraline Rhabdomyolysis Hydrochloride) C Tavor (Lorazepam) C Diazepam C Date:11/25/03ISR Number: 4242846-9Report Type:Expedited (15-DaCompany Report #DE_031012288 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Deep Vein Thrombosis Foreign Initial or Prolonged International Normalised Health Ratio Increased Professional Prothrombin Time Abnormal Company 24-Jun-2005 12:19 PM Page: 2566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS 2.5 MG/3 DAY Carbium (Carbamazepine) C Pantozol C Jodthyrox C Date:11/25/03ISR Number: 4242848-2Report Type:Expedited (15-DaCompany Report #US_031198664 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Foreign Zyprexa Initial or Prolonged Myocardial Infarction Health (Olanzapine) PS ORAL 15 MG/DAY Professional Company Representative Other Date:11/26/03ISR Number: 4242672-0Report Type:Direct Company Report #CTU 206948 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Olanzepine 7.5mg PS ORAL 7.5 MG QHS ORAL Date:11/26/03ISR Number: 4243589-8Report Type:Expedited (15-DaCompany Report #GBS031113995 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 10 MG/1 DAY Microcytic Anaemia Professional Polyarthritis Other Red Blood Cell Sedimentation Rate Increased Date:11/26/03ISR Number: 4243592-8Report Type:Expedited (15-DaCompany Report #GBS031114006 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Foreign Zyprexa-Oral Disturbance In Attention Consumer (Olanzapine) Dysgraphia Other (Olanzapine) PS Memory Impairment Amisulpride C Rectal Haemorrhage Sulpiride C Somnolence 24-Jun-2005 12:19 PM Page: 2567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4243707-1Report Type:Expedited (15-DaCompany Report #JP_031002041 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Anxiety Professional (Olanzapine) PS 10 MG/DAY Aspartate Company Aminotransferase Representative Increased Other Blood Bilirubin Increased Blood Potassium Increased Body Temperature Increased C-Reactive Protein Increased Chromaturia Coma Hepatic Function Abnormal Insomnia Intentional Misuse Somnolence Sputum Discoloured Suicide Attempt White Blood Cell Count Increased Date:11/26/03ISR Number: 4243750-2Report Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Crackles Lung Foreign Zyprexa Hospitalization - Decreased Appetite Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Depressed Level Of Professional Serenace Disability Consciousness Company (Haloperidol) C Other Diabetic Coma Representative Diabetic Ketoacidosis Other Dialysis Hyperventilation Hypotension Malaise Metabolic Acidosis Nausea Obesity Oral Intake Reduced Psychotic Disorder Pyrexia Renal Failure Acute Tachypnoea Thirst Vomiting White Blood Cell Count Increased Date:11/26/03ISR Number: 4243756-3Report Type:Expedited (15-DaCompany Report #JP_030500916 Age:51 YR Gender:Male I/FU:F Outcome PT Death Decreased Appetite General Physical Health 24-Jun-2005 12:19 PM Page: 2568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Deterioration Hepatic Cancer Metastatic Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa Health (Olanzapine) PS 15 MG/DAY Professional Tegretol Company (Carbamazepine) C Representative Other Date:11/26/03ISR Number: 4243758-7Report Type:Expedited (15-DaCompany Report #EWC031036487 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Norepinephrine Increased Foreign Olanzapine Initial or Prolonged Secondary Hypertension Health (Olanzapine) PS 10 MG/DAY Tachycardia Professional Truxal Other (Chlorprothixene Hydrochloride) C Seroquel (Quetiapine Fumarate) Norepinephrine C Clopixol (Zuclopenthixol Decanoate) C Valium (Diazepam) C Akineton Retard (Biperiden Hydrochloride) C Date:11/26/03ISR Number: 4243760-5Report Type:Expedited (15-DaCompany Report #EWC030936368 Age:2 MON Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa-Oral Drug Exposure During Health (Olanzapine) PS 25 WK Pregnancy Professional Premature Baby Other Renal Disorder Date:11/26/03ISR Number: 4243762-9Report Type:Expedited (15-DaCompany Report #EWC030936364 Age:6 DY Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Foreign Zyprexa-Oral Neonatal Health (Olanzapine) PS 25 WK Drug Exposure During Professional Pregnancy Other Premature Baby 24-Jun-2005 12:19 PM Page: 2569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4243782-4Report Type:Expedited (15-DaCompany Report #DE_031012161 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) PS 5 MG/2 DAY Drug Toxicity Professional Remergil Endocarditis Other (Mirtazapine) C Tricuspid Valve Disease Ass C Pantozol (Pantoprazole Sodium) C Sortis (Atorvastatin Calcium) C Lorzaar (Losartan Potassium) C Isoket Retard (Isosorbide Dinitrate) C Corvaton - Slow Release (Molsidomine) C Lorzaar Plus C Beloc Zok (Metoprolol Succinate) C Beloc Zok (Metoprolol Sucinate) C Norvasc (Amlodipine Besilate) C Vancomycin C Gentamycin C Fraxiparin (Heparin-Fraction, Calcium Salt) C Bifiteral (Lactulose) C Klistier C Lecicarbon C Eremfat (Rifampicin Sodium) C Risperdal (Risperidone) C Date:11/26/03ISR Number: 4243820-9Report Type:Expedited (15-DaCompany Report #US_020987573 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG/DAY Aminotransferase Company Hirnamin Increased Representative (Levomepromazine) C Blood Lactate Rohypnol Dehydrogenase Increased (Flunitrazepam) C Gamma-Glutamyltransferase Depas (Etizolam) C Increased Pyrethia Hepatic Function Abnormal (Promethazine Urinary Tract Infection Hydrochloride) C Urine Output Decreased Flomox (Cefcapene 24-Jun-2005 12:19 PM Page: 2570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pivoxil Hydrochloride) C Cravit (Levofloxacin) C Cefmetazon (Cefmetazole Sodium) C Date:11/26/03ISR Number: 4243821-0Report Type:Expedited (15-DaCompany Report #US-010768781 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Initial or Prolonged Dehydrogenase Increased Health Vegetamin B C Hepatic Function Abnormal Professional Flunitrazepam C Jaundice Company Nitrazepam C Representative Sennoside C Polycarbophil Calcium C Date:11/26/03ISR Number: 4244058-1Report Type:Expedited (15-DaCompany Report #USA030948147 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa Oral Deep Vein Thrombosis Professional (Olanzapine) Diabetic Coma Company (Olazapine) PS 60 MG/AT Embolism Representative BEDTIME 7 YR Sudden Death Eskalith Cr (Lithium Weight Increased Carbonate) C Ativan (Lorazepam) C Date:11/26/03ISR Number: 4244171-9Report Type:Expedited (15-DaCompany Report #JP_031102150 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Zyprexa-Oral Loss Of Consciousness Health (Olanzapine)(Olanzap Myocardial Infarction Professional ine) PS 5 MG/3 DAY Company Wypax (Lorazepam) C Representative Benzalin(Nitrazepam) C Other Silece (Flunitrazepam) C Hirnamin(Levomeproma zine) C Eurodin (Estazolam) C Date:11/26/03ISR Number: 4244289-0Report Type:Expedited (15-DaCompany Report #USA031152171 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa Professional Zydis-Dispersible (Olanzapine) (Olanzapine) PS 10 MG/DAY Risperdal (Risperidone) C Nitroglycerin (Glyceryl 24-Jun-2005 12:19 PM Page: 2571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trinitrate) C Remeron (Mirtazapine) C Lasix (Furosemide) C Date:11/26/03ISR Number: 4244292-0Report Type:Expedited (15-DaCompany Report #USA031151923 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Consumer Zyprexa-Oral Haematemesis (Olanzapine) Nausea (Olanzapine) PS 15 MG/AT Vomiting BEDTIME Date:11/26/03ISR Number: 4244339-1Report Type:Expedited (15-DaCompany Report #US_031198740 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Multiple Drug Overdose Professional Amitriptyline C Date:11/26/03ISR Number: 4244371-8Report Type:Expedited (15-DaCompany Report #US_031198769 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Date:11/26/03ISR Number: 4244375-5Report Type:Expedited (15-DaCompany Report #US_031198742 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Doxepin C Gabapentin C Date:11/26/03ISR Number: 4244380-9Report Type:Expedited (15-DaCompany Report #DE_031112335 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apathy Foreign Zyprexa Completed Suicide Health (Olanzapine) PS ORAL 5 MG/DAY Feeling Of Despair Professional Zeldox Other (Ziprasidone Hydrochloride) C Date:11/26/03ISR Number: 4244381-0Report Type:Expedited (15-DaCompany Report #GBS031114019 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Disability Dysphonia Foreign Dyspnoea Health Professional 24-Jun-2005 12:19 PM Page: 2572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS 10 MG Citalopram C Date:11/26/03ISR Number: 4244386-XReport Type:Expedited (15-DaCompany Report #US_031198784 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Codeine C Propoxyphene C Date:11/26/03ISR Number: 4244391-3Report Type:Expedited (15-DaCompany Report #US_031198781 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Literature Olanzapine-Oral Blood Pressure Increased Health (Olanzapine) PS Body Temperature Professional Levothyroxine C Increased Valproic Acid C Electromechanical Dissociation Grand Mal Convulsion Heart Rate Increased Intentional Misuse Overdose Oxygen Saturation Decreased Pulse Absent Respiratory Rate Increased Ventricular Fibrillation Date:11/26/03ISR Number: 4244392-5Report Type:Expedited (15-DaCompany Report #US_031198785 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Olanzapine-Oral Health (Olanzapine) PS Professional Date:11/26/03ISR Number: 4244393-7Report Type:Expedited (15-DaCompany Report #US_031198782 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Aspirin C Ziprasidone C 24-Jun-2005 12:19 PM Page: 2573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244394-9Report Type:Expedited (15-DaCompany Report #US_031198777 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Professional Date:11/26/03ISR Number: 4244395-0Report Type:Expedited (15-DaCompany Report #US_031198776 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Buspirone C Benztropine C Date:11/26/03ISR Number: 4244397-4Report Type:Expedited (15-DaCompany Report #US_031198693 Age:22 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Date:11/26/03ISR Number: 4244401-3Report Type:Expedited (15-DaCompany Report #US_031198788 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Sertraline C Alprazolam C Date:11/26/03ISR Number: 4244403-7Report Type:Expedited (15-DaCompany Report #US_031198786 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Fluoxetine Hydrochloride-Oral (Fluoxetine) SS Date:11/26/03ISR Number: 4244417-7Report Type:Expedited (15-DaCompany Report #US_031198791 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Quetiapine C Oxcarbazepine C 24-Jun-2005 12:19 PM Page: 2574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244418-9Report Type:Expedited (15-DaCompany Report #US_031198760 Age:54 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Sertraline C Clonazepam C Date:11/26/03ISR Number: 4244424-4Report Type:Expedited (15-DaCompany Report #US_031198771 Age:52 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health Olanzapine PS Overdose Professional Diltiazem C Date:11/26/03ISR Number: 4244426-8Report Type:Expedited (15-DaCompany Report #US_031198778 Age:34 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Date:11/26/03ISR Number: 4244427-XReport Type:Expedited (15-DaCompany Report #US_031198780 Age:47 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Date:11/26/03ISR Number: 4244428-1Report Type:Expedited (15-DaCompany Report #US_031198732 Age:32 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Lamotrigine C Venlafaxine C Date:11/26/03ISR Number: 4244430-XReport Type:Expedited (15-DaCompany Report #US_031198790 Age:43 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Venlafaxine C Ephedra C 24-Jun-2005 12:19 PM Page: 2575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244436-0Report Type:Expedited (15-DaCompany Report #US_031198714 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Methadone C Date:11/26/03ISR Number: 4244437-2Report Type:Expedited (15-DaCompany Report #US_031198789 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Intentional Misuse Health (Olanzapine) PS Professional Metformin C Quetiapine C Date:11/26/03ISR Number: 4244442-6Report Type:Expedited (15-DaCompany Report #US_031198717 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Overdose Professional Methadone C Gabapentin C Date:11/26/03ISR Number: 4244443-8Report Type:Expedited (15-DaCompany Report #US_031198720 Age:51 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Olanzapine-Oral Overdose Professional (Olanzapine) PS Carbamazepine C Trazodone C Date:11/26/03ISR Number: 4244456-6Report Type:Expedited (15-DaCompany Report #USA031152034 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Zyprexa-Oral Attack Professional (Olanzapine) PS 2.5 MG/DAY Company Representative Date:11/26/03ISR Number: 4244601-2Report Type:Expedited (15-DaCompany Report #USA031152501 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Consumer Zyprexa-Oral Initial or Prolonged Phlebothrombosis (Olanzapine) Other (Olanzapine) PS 20 MG/DAY 2 YR 24-Jun-2005 12:19 PM Page: 2576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244605-XReport Type:Expedited (15-DaCompany Report #US_031198783 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Completed Suicide Health (Olanzapine) PS Drug Toxicity Professional Citalopram C Date:11/26/03ISR Number: 4244665-6Report Type:Expedited (15-DaCompany Report #US_031198761 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Trazodone C Date:11/26/03ISR Number: 4244773-XReport Type:Expedited (15-DaCompany Report #USA031152472 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Delusion (Olanzapine) Fall (Olanzapine) PS 10 MG Hallucination Zyprexa Insomnia Zydis-Dispersible Refusal Of Treatment By (Olanzapine) Patient (Olanzapine) SS 10 MG Somnolence Haldol(Haloperidol) C Weight Increased Lithium C Date:11/26/03ISR Number: 4244777-7Report Type:Expedited (15-DaCompany Report #US_030393671 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Blood Calcium Decreased (Olanzapine) Blood Urea Decreased (Olanzapine) PS Diabetes Mellitus Glucophage(Metformin Diarrhoea Haemorrhagic Hydrochloride) C Drug Ineffective Glucotrol Endometriosis (Glipizide) C Hepatic Steatosis Zantac(Ranitidine Nephrolithiasis Hydrochloride) C Urinary Retention Zoloft(Sertraline Vaginal Mycosis Hydrochloride) C Vomiting Xenical(Orlistat) C Multivitamin C Date:11/26/03ISR Number: 4244779-0Report Type:Expedited (15-DaCompany Report #USA031152056 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative 24-Jun-2005 12:19 PM Page: 2577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244783-2Report Type:Expedited (15-DaCompany Report #USA031152076 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Depression Professional (Olanzapine) Gun Shot Wound (Olanzapine) PS 5 DAY Date:11/26/03ISR Number: 4244788-1Report Type:Expedited (15-DaCompany Report #USA031152170 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Depakote(Valproate Semisodium) C Date:11/26/03ISR Number: 4244905-3Report Type:Expedited (15-DaCompany Report #USA030435794 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zyprexa-Oral Dizziness Professional (Olanzapine) Echocardiogram Abnormal Company (Olanzapine) PS 10 MG/AT Hypotension Representative BEDTIME Loss Of Consciousness Atenolol C Refusal Of Treatment By Patient Syncope Date:11/26/03ISR Number: 4265452-9Report Type:Periodic Company Report #USA030535901 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Blood Thyroid Stimulating Professional (Olanzapine) Hormone Increased Company (Olanzapine) PS 5 MG/DAY Feeling Cold Representative Hyporeflexia Date:11/28/03ISR Number: 4244791-1Report Type:Expedited (15-DaCompany Report #2003-110416-NL Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Mirtazapine PS ORAL 30 MG/ 45 MG Increased Professional Olanzapine SS ORAL 9 DAY Aspartate Amisulpride SS ORAL 100 MG 3 DAY Aminotransferase Hexachlorophene C Increased Movicol C Blood Alkaline Potassium Chloride C Phosphatase Increased Heparin -Fraction, Blood Lactate Sodium Salt C Dehydrogenase Increased Gamma-Glutamyltransferase Increased Parkinsonism Psychotic Disorder 24-Jun-2005 12:19 PM Page: 2578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4244925-9Report Type:Expedited (15-DaCompany Report #2003-04122 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Doxepin(Watson Health Laboratories)(Doxepi Professional n Hydrochloride) Capsule PS Gabapentin (Gabapentin) SS Olanzapine (Olanzapine) SS Date:11/28/03ISR Number: 4245090-4Report Type:Expedited (15-DaCompany Report #S03-UKI-04810-01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dysphonia Foreign Cipramil (Citalopram Health Hydrobromide) PS ORAL 20 MG QD PO Professional Olanzapine SS ORAL 10 MG QD PO Other Date:11/28/03ISR Number: 4245220-4Report Type:Expedited (15-DaCompany Report #2003-04223 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Propoxyphene Health Hydrochloride Professional /Acetaminophen 65/650 (Watson Laboratoratories)(Ac PS Acetaminophen/Codein e Phosphate Unknown Strength (Watson Laboratories)(Acetam inophen, Codiene SS Olanzapine (Olanzapine) SS Date:11/28/03ISR Number: 4255816-1Report Type:Periodic Company Report #USA030537480 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Zyprexa-Oral Priapism Professional (Olanzapine) (Olanzapine) PS 7.5 MG/DAY Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4255819-7Report Type:Periodic Company Report #USA030537493 Age: Gender:Female I/FU:I Outcome PT Akathisia Depression Dyskinesia Extrapyramidal Disorder Irritability 24-Jun-2005 12:19 PM Page: 2579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prescribed Overdose Restlessness Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 25 MG IN THE EVENING Cogentin (Benzatropine Mesilate) C Lithium C Paxil (Paroxetine Hydrochloride) C Premarin (Estrogens Conjugated) C Date:11/28/03ISR Number: 4255821-5Report Type:Periodic Company Report #USA030537584 Age:15 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertriglyceridaemia Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Date:11/28/03ISR Number: 4255823-9Report Type:Periodic Company Report #USA030537588 Age:29 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertriglyceridaemia Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Date:11/28/03ISR Number: 4255825-2Report Type:Periodic Company Report #USA030537639 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4255826-4Report Type:Periodic Company Report #USA030537645 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4255828-8Report Type:Periodic Company Report #USA030537751 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa-Oral Mania Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY 2 DAY Representative Date:11/28/03ISR Number: 4255829-XReport Type:Periodic Company Report #USA030537788 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa-Oral Somnolence (Olanzapine) (Olanzapine) PS 5 MG/DAY Dexedrine (Dexamfetamine Sulfate) C Chromium Picolinate C Multivitamin C Date:11/28/03ISR Number: 4255832-XReport Type:Periodic Company Report #USA030537832 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Consumer Zyprexa-Oral Dizziness (Olanzapine) Emotional Disorder (Olanzapine) PS 10 MG Hypersomnia Zyrtec (Cetirizine Hypotension Hydrochloride) C Lethargy Medication Error Somnolence Vision Blurred Date:11/28/03ISR Number: 4255833-1Report Type:Periodic Company Report #USA030537137 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Disorder Health Zyprexa-Oral Pitting Oedema Professional (Olanzapine) Weight Increased Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4255835-5Report Type:Periodic Company Report #USA030537143 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Disorder Health Zyprexa-Oral Pitting Oedema Professional (Olanzapine) Weight Increased Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4255836-7Report Type:Periodic Company Report #USA030537172 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Tardive Dyskinesia Professional (Olanzapine) Company (Olanzapine) PS 45 MG/DAY Representative Date:11/28/03ISR Number: 4255848-3Report Type:Periodic Company Report #USA030537209 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Anxiety (Olanzapine) Drug Ineffective (Olanzapine) PS 20 MG/DAY Nervousness Lithobid (Lithium Carbonate) C Trazodone C Xanax (Alprazolam) C Date:11/28/03ISR Number: 4255866-5Report Type:Periodic Company Report #USA030537228 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Impairment Consumer Zyprexa-Oral Tinnitus (Olanzapine) (Olanzapine) PS Trilapon (Perphenazine) C Lorazepam C Date:11/28/03ISR Number: 4255867-7Report Type:Periodic Company Report #USA030537274 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Health Zyprexa-Oral Somnolence Professional (Olanzapine) Syncope (Olanzapine) PS 20 MG/DAY Haldol (Haloperidol) C Date:11/28/03ISR Number: 4255868-9Report Type:Periodic Company Report #USA030537331 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Lorazepam C Colace (Docusate Sodium) C Ambien (Zolpidem Tartrate) C Multivitamin C Percocet C Insulin C 24-Jun-2005 12:19 PM Page: 2582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4255869-0Report Type:Periodic Company Report #USA030537420 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS Date:11/28/03ISR Number: 4255873-2Report Type:Periodic Company Report #USA030537447 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa-Oral Temperature Intolerance Professional (Olanzapine) Company (Olanzapine) PS 1.75 MG/2 DAY Representative Date:11/28/03ISR Number: 4255874-4Report Type:Periodic Company Report #USA030537479 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Head Injury Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4255876-8Report Type:Periodic Company Report #USA030536592 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) (Olanzapine) PS 25 MG/DAY Depakote (Valproate Semisodium) C Seroquel (Quetiapine Fumarate) C Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4255878-1Report Type:Periodic Company Report #USA030536596 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa-Oral Abnormal Professional (Olanzapine) Prescribed Overdose Company (Olanzapine) PS 30 MG/DAY Representative Date:11/28/03ISR Number: 4255898-7Report Type:Periodic Company Report #USA030536711 Age: Gender:Female I/FU:I Outcome PT Asthenia Drug Ineffective Faecal Incontinence Fall 24-Jun-2005 12:19 PM Page: 2583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Feeling Abnormal Parkinsonian Gait Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/DAY Clonazepam C Alprazolam C Lamotrigine C Imipramine C Levetiracetam C Date:11/28/03ISR Number: 4255907-5Report Type:Periodic Company Report #USA030536736 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Diabetes Mellitus Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/AT Representative BEDTIME Date:11/28/03ISR Number: 4255911-7Report Type:Periodic Company Report #USA030536745 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Catatonia Health Zyprexa-Oral Musculoskeletal Stiffness Professional (Olanzapine) Parkinsonism (Olanzapine) PS 5 MG/DAY 1 YR Staring Aricept (Donepezil Hydrochloride) C Ativan (Lorazepam) C Bextra (Valdecoxib) C Decadron (Dexamethasone) C Milk Of Magnesia C Synthroid (Levothyroxine Sodium) C Date:11/28/03ISR Number: 4255944-0Report Type:Periodic Company Report #USA030536862 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Interest Consumer Zyprexa-Oral Hypersomnia (Olanzapine) Neglect Of Personal (Olanzapine) PS 5 MG/AT Appearance BEDTIME Klonopin (Clonazepam) C Luvox (Fluvoxamine Maleate) C 24-Jun-2005 12:19 PM Page: 2584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4255945-2Report Type:Periodic Company Report #USA030537067 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting In Pregnancy Consumer Zyprexa-Oral Weight Decreased (Olanzapine) (Olanzapine) PS 10 MG/DAY Albuterol C Lexapro (Escitalopram) C Date:11/28/03ISR Number: 4255947-6Report Type:Periodic Company Report #USA030537084 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oral Discomfort Consumer Zyprexa Paraesthesia Zydis-Dispersible (Olanzapine) (Olanzapine) PS 20 MG/AT BEDTIME Topamax (Topiramate) C Date:11/28/03ISR Number: 4255948-8Report Type:Periodic Company Report #USA030537099 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Disorder Health Zyprexa-Oral Pitting Oedema Professional (Olanzapine) Weight Increased Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4255949-XReport Type:Periodic Company Report #USA030537115 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa-Oral Dysphagia (Olanzapine) Fluid Retention (Olanzapine) PS 15 MG/AT Gait Disturbance BEDTIME Masked Facies Risperdal Muscle Tightness (Risperidone) C Muscle Twitching Musculoskeletal Stiffness Pollakiuria Somnolence Tremor Urinary Incontinence Weight Increased Date:11/28/03ISR Number: 4256262-7Report Type:Periodic Company Report #USA030535919 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) (Olanzapine) PS 20 MG Clonazepam C Serzone (Nefazodone 24-Jun-2005 12:19 PM Page: 2585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/28/03ISR Number: 4256263-9Report Type:Periodic Company Report #USA030536057 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:11/28/03ISR Number: 4256264-0Report Type:Periodic Company Report #USA030536089 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa-Oral Increased Professional (Olanzapine) Aspartate (Olanzapine) PS 30 MG/DAY Aminotransferase Hydroxyzine C Increased Prescribed Overdose Date:11/28/03ISR Number: 4256265-2Report Type:Periodic Company Report #USA030536183 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Nausea Professional (Olanzapine) Company (Olanzapine) PS 20 MG 2 YR Representative Date:11/28/03ISR Number: 4256266-4Report Type:Periodic Company Report #USA030536235 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Zyprexa-Oral Increased Professional (Olanzapine) Weight Increased Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4256267-6Report Type:Periodic Company Report #USA030536238 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa-Oral Swelling Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 5 MG/DAY Representative Depakote (Valproate Semisodium) C Xanax (Alprazolam) C Estrogen C 24-Jun-2005 12:19 PM Page: 2586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256268-8Report Type:Periodic Company Report #USA030536319 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa-Oral Phosphokinase Increased Professional (Olanzapine) Muscular Weakness (Olanzapine) PS 30 MG/DAY Prescribed Overdose Date:11/28/03ISR Number: 4256269-XReport Type:Periodic Company Report #USA030536149 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Jaundice Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Vomiting Company (Olanzapine) PS 35 MG/DAY Representative Remeron (Mitrazapine) C Date:11/28/03ISR Number: 4256270-6Report Type:Periodic Company Report #USA030536452 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Health Zyprexa-Oral Delusion Professional (Olanzapine) Halitosis Company (Olanzapine) PS 15 MG/DAY Neutropenia Representative Effexor (Vanlafaxine Polydipsia Hydrochloride) C Weight Decreased Date:11/28/03ISR Number: 4256271-8Report Type:Periodic Company Report #USA030536473 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG/DAY Unknown Atypical Antypsychotics C Date:11/28/03ISR Number: 4256272-XReport Type:Periodic Company Report #USA030435634 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen False Health Zyprexa-Oral Positive Professional (Olanzapine) Company (Olanzapine) PS ORAL Representative Date:11/28/03ISR Number: 4256273-1Report Type:Periodic Company Report #USA030435635 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen False Health Zyprexa-Oral Positive Professional (Olanzapine) Company (Olanzapine) PS ORAL Representative 24-Jun-2005 12:19 PM Page: 2587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256274-3Report Type:Periodic Company Report #USA030435636 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen False Health Zyprexa-Oral Positive Professional (Olanzapine) Company (Olanzapine) PS ORAL Representative Date:11/28/03ISR Number: 4256275-5Report Type:Periodic Company Report #USA030435713 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa-Oral Syndrome Professional (Olanzapine) Company (Olanzapine) PS ORAL 15 MG/DAY Representative Abilify (Aripiprazole) C Gabitril (Tiagabine Hydrochloride) C Lexapro (Escitalopram) C Lorazepam C Date:11/28/03ISR Number: 4256276-7Report Type:Periodic Company Report #USA030435751 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS ORAL 7.5 MG/DAY Aciphex(Rabeprazole Sodium) C Aricept(Donepezil Hydrochloride) C Date:11/28/03ISR Number: 4256277-9Report Type:Periodic Company Report #USA030535827 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS ORAL 2 MON Representative Tofranil(Imipramine Hydrochloride) C Date:11/28/03ISR Number: 4256278-0Report Type:Periodic Company Report #USA030535838 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Zyprexa-Oral Fluid Retention (Olanzapine) Hypersomnia (Olanzapine) PS ORAL 10 MG/DAY 2 YR Weight Increased 24-Jun-2005 12:19 PM Page: 2588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256279-2Report Type:Periodic Company Report #USA030535879 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS ORAL Representative Date:11/28/03ISR Number: 4256280-9Report Type:Periodic Company Report #USA030535880 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swelling Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS ORAL 10 MG/DAY Representative Date:11/28/03ISR Number: 4256281-0Report Type:Periodic Company Report #USA030535890 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swelling Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS ORAL Representative Date:11/28/03ISR Number: 4256734-5Report Type:Periodic Company Report #USA030435329 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa-Oral Skin Striae Professional (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4256736-9Report Type:Periodic Company Report #USA030435367 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Consumer Strattera Impulsive Behaviour (Atomoxetine Insomnia Hydrochloride) PS 40 MG/IN THE MORNING Zyprexa Zydis-Oral (Olanzapine) (Olanzapine) SS 10 MG/IN THE EVENING Paxil (Paroxetine Hydrochloride) C Date:11/28/03ISR Number: 4256738-2Report Type:Periodic Company Report #USA030435388 Age:13 YR Gender:Male I/FU:I Outcome PT Asthenia Fatigue Feeling Abnormal 24-Jun-2005 12:19 PM Page: 2589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypersomnia Infection Personality Change Report Source Product Role Manufacturer Route Dose Duration Consumer Strattera (Atomoxetine Hydrochloride) PS 40 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/DAY Valproic Acid C Date:11/28/03ISR Number: 4256741-2Report Type:Periodic Company Report #USA030435415 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa-Oral Extrapyramidal Disorder Professional (Olanzapine) Parkinsonism (Olanzapine) PS 25 MG/DAY Prescribed Overdose Lipitor (Atorvastatin) C Lisinopril C Lithium C Luvox (Fluvoxamine Maleate) C Date:11/28/03ISR Number: 4256743-6Report Type:Periodic Company Report #USA030435458 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Company Zyprexa-Oral Abnormal Representative (Olanzapine) (Olanzapine) PS Geodon (Ziprasidone Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Neurontin (Gabapentin) C Date:11/28/03ISR Number: 4256744-8Report Type:Periodic Company Report #USA030435460 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Date:11/28/03ISR Number: 4256745-XReport Type:Periodic Company Report #USA030435497 Age:26 YR Gender:Male I/FU:I Outcome PT Blood Glucose Increased Choking Dizziness Postural Extrasystoles Fatigue 24-Jun-2005 12:19 PM Page: 2590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Cold Photophobia Somnolence Report Source Product Role Manufacturer Route Dose Duration Tremor Consumer Zyprexa-Oral Weight Decreased (Olanzapine) Weight Increased (Olanzapine) PS 20 MG/DAY Depakote (Valproate Semisodium) C Zyrtec (Cetirizine Hydrochloride) C Vitamins C Date:11/28/03ISR Number: 4256746-1Report Type:Periodic Company Report #USA030435552 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Educational Problem Consumer Zyprexa-Oral Hunger (Olanzapine) Hypersomnia (Olanzapine) PS 5 MG/AT Weight Increased BEDTIME Allegra (Fexofenadine Hydrochloride) C Zyrtec (Cetirizine Hydrochloride) C Singulair (Montelukast Sodium) C Date:11/28/03ISR Number: 4256747-3Report Type:Periodic Company Report #USA030435557 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 15 MG/DAY Ritalin(Methylphenid ate Hydrochloride) C Ritalin-Sr(Methylphe nidate Hydrochloride) C Date:11/28/03ISR Number: 4256748-5Report Type:Periodic Company Report #USA030435631 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) (Olanzapine) PS 40 MG/DAY Date:11/28/03ISR Number: 4256749-7Report Type:Periodic Company Report #USA030434882 Age:51 YR Gender:Female I/FU:I Outcome PT Flatulence Joint Swelling Muscle Spasms Oedema Peripheral 24-Jun-2005 12:19 PM Page: 2591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/AT BEDTIME Prozac C Date:11/28/03ISR Number: 4256750-3Report Type:Periodic Company Report #USA030434994 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Lactic Acid Health Zyprexa-Oral Increased Professional (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4256751-5Report Type:Periodic Company Report #USA030435085 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Zyprexa-Oral Hyperglycaemia Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 7.5 MG/DAY Representative Albuterol C Celexa (Citalopram) C Ibuprofen C Ranitidine C Sulfamethoxazole C Date:11/28/03ISR Number: 4256752-7Report Type:Periodic Company Report #USA030435086 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Potassium Decreased Consumer Zyprexa-Oral Fluid Retention (Olanzapine) Immune System Disorder (Olanzapine) PS 8 MON Rash Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Celexa (Citalopram Hydrochloride) C Ativan (Lorazepam) C Date:11/28/03ISR Number: 4256753-9Report Type:Periodic Company Report #USA030435089 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 2.3 MG/DAY Representative Wellbutrin (Bupropion Hydrochloride) C Zocor (Simvastatin) C Serzone (Nefazodone 24-Jun-2005 12:19 PM Page: 2592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/28/03ISR Number: 4256755-2Report Type:Periodic Company Report #USA030435136 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oligomenorrhoea Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/AT BEDTIME Date:11/28/03ISR Number: 4256756-4Report Type:Periodic Company Report #USA030435154 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen False Consumer Zyprexa-Oral Positive (Olanzapine) (Olanzapine) PS Atenolol C Elvail (Amitriptyline Hydrochloride) C Hydrochlorothiazide C Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4256758-8Report Type:Periodic Company Report #USA030435234 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa-Oral Bipolar Disorder (Olanzapine) Eating Disorder (Olanzapine) PS 5 MG Feeling Jittery Ambien (Zolpidem Insomnia Tartrate) C Tremor Celebrex (Celecoxib) C Celexa (Citalopram) C Depaxote (Valproate Semisodium) C Lipitor (Atorvastatin) C Tegretol (Carbamazepine) C Date:11/28/03ISR Number: 4256759-XReport Type:Periodic Company Report #USA030435251 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperprolactinaemia Health Zyprexa-Oral Hypothalamo-Pituitary Professional (Olanzapine) Disorders (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256760-6Report Type:Periodic Company Report #USA030435296 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overweight Consumer Zyprexa-Oral Social Problem (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4256762-XReport Type:Periodic Company Report #USA030434527 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Consumer Zyprexa-Oral Feeling Drunk (Olanzapine) Hypersomnia (Olanzapine) PS 10 MG/3 DAY Incoherent Prescribed Overdose Date:11/28/03ISR Number: 4256764-3Report Type:Periodic Company Report #USA030434543 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa-Oral Glossitis Health (Olanzapine) Glossodynia Professional (Olanzapine) PS 2.5 MG/2 DAY Liver Function Test Company Zoloft (Sertraline Abnormal Representative Hydrochloride) C Sexually Transmitted Buspar (Buspirone Disease Hydrochloride) C Weight Decreased Trazodone C Lorazepam C Ambien (Zolpidem Tartrate) C Remeron (Mirtazapine) C Toprol Xl (Metoprolol Succinate) C Date:11/28/03ISR Number: 4256766-7Report Type:Periodic Company Report #USA030434545 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Strattera Drug Ineffective Professional (Atomoxetine Prescribed Overdose Company Hydrochloride) PS 18 MG/2 DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/DAY Date:11/28/03ISR Number: 4256768-0Report Type:Periodic Company Report #USA030434548 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Drug Interaction Professional (Olanzapine) Company (Olanzapine) PS Representative Clomipramine C 24-Jun-2005 12:19 PM Page: 2594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256770-9Report Type:Periodic Company Report #USA030434550 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Drug Interaction Professional (Olanzapine) Company (Olanzapine) PS Representative Clomipramine C Date:11/28/03ISR Number: 4256772-2Report Type:Periodic Company Report #USA030434570 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 25 MG/DAY Date:11/28/03ISR Number: 4256773-4Report Type:Periodic Company Report #USA030434625 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glycosylated Haemoglobin Health Zyprexa-Oral Increased Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4256775-8Report Type:Periodic Company Report #USA030434638 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4256779-5Report Type:Periodic Company Report #USA030434645 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa-Oral Hunger (Olanzapine) Hypersomnia (Olanzapine) PS 20 MG/DAY Initial Insomnia Prozac-Oral Metabolic Disorder (Fluoxetine) Weight Increased (Fluoxetine Hydrochloride) SS 40 MG/DAY Excedrin C Midrin C Ortho Tri-Cyclen C Depakote (Valproate Semisodium) C Xenadrine Rfa-1 C 24-Jun-2005 12:19 PM Page: 2595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256782-5Report Type:Periodic Company Report #USA030434660 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa-Oral Hypoglycaemia Professional (Olanzapine) Malaise Company (Olanzapine) PS 5 MG/DAY Nausea Representative Adderall C Peripheral Coldness Wellbutrin Weight Increased (Bupropion Hydrochloride) C Date:11/28/03ISR Number: 4256783-7Report Type:Periodic Company Report #USA030640246 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertrophy Breast Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS ORAL 2.5 MG 18 MON Representative Date:11/28/03ISR Number: 4256785-0Report Type:Periodic Company Report #USA030640342 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Aggression (Olanzapine) Emotional Disorder (Olanzapine) PS ORAL 20 MG Energy Increased Depakote - Slow Mania Release(Valproate Thinking Abnormal Semisodium) C Fluoxetine Hydrochloride C Plendil (Felodipine) C Topamax (Topiramate) C Date:11/28/03ISR Number: 4256787-4Report Type:Periodic Company Report #USA030740513 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS ORAL 10 MG/DAY Representative Efexor (Venlafaxine Hydrochloride) C Date:11/28/03ISR Number: 4256790-4Report Type:Periodic Company Report #USA030740517 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Non-Insulin-Dependent (Olanzapine) Fluid Retention (Olanzapine) PS ORAL 15 MG/DAY Hyperglycaemia Exfexor-Xr (Venlafaxine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256791-6Report Type:Periodic Company Report #USA030740578 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4256792-8Report Type:Periodic Company Report #USA030740590 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Rash Professional (Olanzapine) Company (Olanzapine) PS ORAL 35 MG/DAY Representative Geoden (Ziprasidone Hydrochloride) C Date:11/28/03ISR Number: 4256794-1Report Type:Periodic Company Report #USA030740608 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Follicle Consumer Zyprexa-Oral Stimulating Hormone (Olanzapine) Increased (Olanzapine) PS ORAL Blood Prolactin Increased Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4256795-3Report Type:Periodic Company Report #USA030740611 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Consumer Zyprexa-Oral Insomnia (Olanzapine) Tremor (Olanzapine) PS ORAL 5 MG 17 MON Date:11/28/03ISR Number: 4256797-7Report Type:Periodic Company Report #USA030740645 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa-Oral Non-Insulin-Dependent Professional (Olanzapine) Company (Olanzapine) PS ORAL Representative Date:11/28/03ISR Number: 4256798-9Report Type:Periodic Company Report #USA030740652 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Personality Change Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS ORAL 25 MG/DAY Representative Buspar(Buspirone Hydrochloride) C Depakote(Valproate Semisodium) C Geoden (Ziprasidone 24-Jun-2005 12:19 PM Page: 2597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Risperdal (Risperidone) C Wellbutrin (Bupropion Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4256807-7Report Type:Periodic Company Report #USA030741098 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Consumer Zyprexa-Oral Dizziness (Olanzapine) Dyspnoea (Olanzapine) PS 20 MG/2 DAY Prescribed Overdose Cozaar (Losartan Weight Increased Potassium) C Atenolol C Effexor (Venlafaxine Hydrochloride) C Trazadone (Trazadone) C Cyclobenzaprine C Topamax (Topiramate) C Furosemide C Date:11/28/03ISR Number: 4256810-7Report Type:Periodic Company Report #USA030741160 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4256812-0Report Type:Periodic Company Report #USA030741161 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4256813-2Report Type:Periodic Company Report #USA030741162 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256814-4Report Type:Periodic Company Report #USA030741163 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4256815-6Report Type:Periodic Company Report #USA030741174 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Delusion Professional (Olanzapine) Diabetes Mellitus Company (Olanzapine) PS 2.5 MG Representative Date:11/28/03ISR Number: 4256816-8Report Type:Periodic Company Report #USA030741230 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Health Zyprexa-Oral Dizziness Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4256817-XReport Type:Periodic Company Report #USA030741256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa Mental Disorder Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS 50 MG Risperdal (Risperidone) C Date:11/28/03ISR Number: 4256818-1Report Type:Periodic Company Report #USA030741264 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Aspirin C Glucophage (Metformin Hydrochloride) C Insulin C Date:11/28/03ISR Number: 4256819-3Report Type:Periodic Company Report #USA030741268 Age:31 YR Gender:Female I/FU:I Outcome PT Emotional Distress Prescribed Overdose 24-Jun-2005 12:19 PM Page: 2599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 25 MG/IN THE EVENING Vitamins Nos C Oral Contraceptive Nos C Date:11/28/03ISR Number: 4256820-XReport Type:Periodic Company Report #USA030741293 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Zyprexa-Oral Aggression (Olanzapine) Anxiety (Olanzapine) PS 30 MG/DAY Apathy Strattera Drug Ineffective (Atomoxetine Insomnia Hydrochloride) SS 40 MG Irritability Lithium C Nervousness Panic Attack Prescribed Overdose Psychomotor Hyperactivity Somnolence Date:11/28/03ISR Number: 4256821-1Report Type:Periodic Company Report #USA030741316 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Zyprexa-Oral Lower Extremity Mass (Olanzapine) Medication Error (Olanzapine) PS 10 MG/DAY 6 DAY Swelling Glucophage (Metformin Hydrochloride) C Naprosyn Ec (Naproxen) C Effexor-Xr (Venlafaxine Hydrochloride) C Singulair (Montelukast Sodium) C Advair Diskus C Rhinocort (Budesonide) C Celexa (Citalopram Hydrobromide) C Lasix (Furosemide) C Aldactone (Spironolactone) C Xanax (Alprazolam) C Synthroid (Levothyroxine Sodium) C Estrace (Estradiol) C Zyrtec (Ceftirizine 24-Jun-2005 12:19 PM Page: 2600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Allergy Shot C Aspirin C Chromium Picolinate C Date:11/28/03ISR Number: 4256822-3Report Type:Periodic Company Report #USA030741402 Age:12 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 15 MG Representative Date:11/28/03ISR Number: 4256823-5Report Type:Periodic Company Report #USA030741467 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Burning Sensation Consumer Zyprexa-Oral Feeling Abnormal (Olanzapine) Headache (Olanzapine) PS 30 MG/DAY Hypoaesthesia Ativan (Lorazepam) C Mania Nicotine Dependence Prescribed Overdose Date:11/28/03ISR Number: 4256824-7Report Type:Periodic Company Report #USA030741527 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blindness Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4256825-9Report Type:Periodic Company Report #USA030741569 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa-Oral Hypercholesterolaemia Professional (Olanzapine) Hypertriglyceridaemia (Olanzapine) PS Weight Increased Effexor (Venlafaxine Hydrochloride) C Date:11/28/03ISR Number: 4256826-0Report Type:Periodic Company Report #USA030741652 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vestibulitis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4256827-2Report Type:Periodic Company Report #USA030741743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lipids Increased Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Psychotic Disorder (Olanzapine) PS 40 MG/DAY Weight Increased Date:11/28/03ISR Number: 4256828-4Report Type:Periodic Company Report #USA030741781 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Marrow Disorder Health Zyprexa-Oral Red Blood Cell Professional (Olanzapine) Abnormality (Olanzapine) PS 15 MG/DAY Date:11/28/03ISR Number: 4256829-6Report Type:Periodic Company Report #USA030741787 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Health Zyprexa-Oral Hypersomnia Professional (Olanzapine) Medication Error (Olanzapine) PS 10 MG Vision Blurred Zyrtec (Ceftirizine Hydrochloride) C Date:11/28/03ISR Number: 4257067-3Report Type:Periodic Company Report #USA030538239 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Consumer Zyprexa-Oral Increased Appetite (Olanzapine) Weight Decreased (Olanzapine) PS 3 MON Weight Increased Depakote C Water Pill C Date:11/28/03ISR Number: 4257073-9Report Type:Periodic Company Report #USA030538319 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 20MG/DAY Representative Date:11/28/03ISR Number: 4257078-8Report Type:Periodic Company Report #USA030538416 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Xanax C 24-Jun-2005 12:19 PM Page: 2602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4257079-XReport Type:Periodic Company Report #USA030638430 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) 20mg/Day PS Lithobid C Trileptal C Dilantin C Date:11/28/03ISR Number: 4257081-8Report Type:Periodic Company Report #USA030638455 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY 2 WK Representative Paxil C Lipitor C Marzulene C Date:11/28/03ISR Number: 4257082-XReport Type:Periodic Company Report #USA030638536 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa-Oral Disturbance In Attention (Olanzapine) Dysphagia (Olanzapine) PS 10 MG/DAY Hunger Zantac C Insomnia Lethargy Urinary Retention Weight Increased Date:11/28/03ISR Number: 4257083-1Report Type:Periodic Company Report #USA030638675 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa-Oral Fungal Infection Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:11/28/03ISR Number: 4257084-3Report Type:Periodic Company Report #USA030638748 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Consumer Zyprexa-Oral Sluggishness (Olanzapine) Somnolence (Olanzapine) PS 15 MG / NOT APPLICABLE . C 24-Jun-2005 12:19 PM Page: 2603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4257085-5Report Type:Periodic Company Report #USA030638837 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa-Oral Mania Professional (Olanzapine) Prescribed Overdose Company (Olanzapine) PS 50 MG/DAY Representative Geodon C Klonopin C Risperdal C Date:11/28/03ISR Number: 4257086-7Report Type:Periodic Company Report #USA030638859 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Mood Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:11/28/03ISR Number: 4257125-3Report Type:Periodic Company Report #USA030638898 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hearing Impaired Health Zyprexa-Oral Influenza Professional (Olanzapine) (Olanzapine) PS 5 MG Wellbutrin (Bupropion Hydrochloride) C Date:11/28/03ISR Number: 4257126-5Report Type:Periodic Company Report #USA030638910 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Health Strattera Professional (Atomoxetine Company Hydrochloride) PS 4 MON Representative Olanzapine-Oral (Olanzapine) SS 1 WK Celexa (Citalopram Hydrobromide) C Date:11/28/03ISR Number: 4257141-1Report Type:Periodic Company Report #USA030639037 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Consumer Zyprexa-Oral Eating Disorder (Olanzapine) Somnolence (Olanzapine) PS 2.5 MG/DAY Enalapril C Date:11/28/03ISR Number: 4257142-3Report Type:Periodic Company Report #USA030639167 Age:50 YR Gender:Female I/FU:I Outcome PT Arthralgia Difficulty In Walking 24-Jun-2005 12:19 PM Page: 2604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyskinesia Feeling Abnormal Increased Appetite Report Source Product Role Manufacturer Route Dose Duration Somnolence Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 10 MG/DAY Ativan (Lorazepam) C Effexor-Xr (Venlafaxine Hydrochloride) C Singulair (Montelukast Sodium) C Ventolin (Salbutamol) C Clonidine C Date:11/28/03ISR Number: 4257151-4Report Type:Periodic Company Report #USA030639210 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa-Oral Mania (Olanzapine) Prescribed Overdose (Olanzapine) PS 25 MG/DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/DAY Wellbutrin (Bupropion Hydrochloride) C Date:11/28/03ISR Number: 4257152-6Report Type:Periodic Company Report #USA030639221 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Balance Disorder (Olanzapine) Hyperhidrosis (Olanzapine) PS 15 MG/1 IN Lethargy THE EVENING Trileptal (Oxcarbazepine) C Date:11/28/03ISR Number: 4257198-8Report Type:Periodic Company Report #USA030639239 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Loss Of Libido Consumer Zyprexa-Oral Premature Ejaculation (Olanzapine) Sexual Dysfunction (Olanzapine) PS 15 MG/DAY Date:11/28/03ISR Number: 4257200-3Report Type:Periodic Company Report #USA030639352 Age:50 YR Gender:Female I/FU:I Outcome PT Agitation Blunted Affect Prescribed Overdose 24-Jun-2005 12:19 PM Page: 2605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sensation Of Heaviness Thought Blocking Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS 30 MG Klonopin (Clonazepam) C Lamictal C Lasix (Furosemide) C Potassium C Premarin (Estrogens Conjugated) C Date:11/28/03ISR Number: 4257220-9Report Type:Periodic Company Report #USA030639368 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Consumer Zyprexa-Oral Cystitis (Olanzapine) Insomnia (Olanzapine) PS 5 MG/DAY Sleep Talking Aromasin (Exemestane) C Paxil (Paroxetine Hydrochloride) C Reminyl (Galantamine Hydrobromide) C Sinemet C Trazadone C Date:11/28/03ISR Number: 4257221-0Report Type:Periodic Company Report #USA030639604 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa-Oral Increased Appetite Professional (Olanzapine) Psychomotor Hyperactivity Company (Olanzapine) PS 15 MG/DAY Weight Increased Representative Depakote (Valproate Semisodium) C Wellbutrin Sr (Bupropion Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Haloperidol C Date:11/28/03ISR Number: 4257224-6Report Type:Periodic Company Report #USA030639617 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Headache (Olanzapine) Nausea (Olanzapine) PS 5 MG/DAY Fluoxetine Hydrochloride C 24-Jun-2005 12:19 PM Page: 2606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4257226-XReport Type:Periodic Company Report #USA030639644 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Zyprexa-Oral Medication Error (Olanzapine) (Olanzapine) PS 15 MG Date:11/28/03ISR Number: 4257228-3Report Type:Periodic Company Report #USA030639719 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa-Oral Feeling Abnormal (Olanzapine) (Olanzapine) PS 5 MG/DAY Aspirin C Atenolol C Entacapone C Klor-Con (Potassium Chloride) C Lipitor (Atorvastatin) C Lotensin (Benazepril Hydrochloride) C Minitran (Glyceryl Trinitrate) C Mirapex (Mirapex) C Plavix (Clopidogrel Sulfate) C Carbidopa C Synthroid (Levothyroxine Sodium) C Date:11/28/03ISR Number: 4257230-1Report Type:Periodic Company Report #USA030639779 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:11/28/03ISR Number: 4257233-7Report Type:Periodic Company Report #USA030639781 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa-Oral Anxiety Professional (Olanzapine) Logorrhoea Company (Olanzapine) PS 5 MG 4 WK Mania Representative Date:11/28/03ISR Number: 4257236-2Report Type:Periodic Company Report #USA030639789 Age: Gender:Male I/FU:I Outcome PT Dizziness Eye Disorder 24-Jun-2005 12:19 PM Page: 2607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eye Swelling Feeling Abnormal Keratoconjunctivitis Report Source Product Role Manufacturer Route Dose Duration Sicca Consumer Zyprexa-Oral Medication Error (Olanzapine) Miosis (Olanzapine) PS 10 MG/DAY Nasal Congestion Somnolence Speech Disorder Date:11/28/03ISR Number: 4257238-6Report Type:Periodic Company Report #USA030639799 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 45 MG/DAY Celexa (Citalopram Hydrobromide) C Xanax (Alprazolam) C Date:11/28/03ISR Number: 4257240-4Report Type:Periodic Company Report #USA030639800 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Health Zyprexa-Oral Oedema Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4257242-8Report Type:Periodic Company Report #USA030639815 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Strattera Professional (Atomoxetine Company Hydrochloride) PS 80 MG/AT Representative BEDTIME Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 80 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG/AT BEDTIME Adderall Xr C Nexium (Esomeprazole) C Date:11/28/03ISR Number: 4257243-XReport Type:Periodic Company Report #USA030639853 Age:51 YR Gender:Female I/FU:I Outcome PT Dizziness Eye Pain Muscle Twitching 24-Jun-2005 12:19 PM Page: 2608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Somnolence Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Swelling Face Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/DAY Paxil (Paroxetine Hydrochloride) C Cipro (Ciprofloxacin Hydrochloride) C Loratadine C Hydroxyzine C Flexeril (Cyclobenzaprine Hydrochloride) C Date:11/28/03ISR Number: 4257245-3Report Type:Periodic Company Report #USA030639876 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa Oral Professional (Olanzapine) PS Company Representative Date:11/28/03ISR Number: 4257248-9Report Type:Periodic Company Report #USA030639889 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Systemic Lupus Health Zyprexa Oral Erythematosus Professional (Olanzapine) PS Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Lithium C Tegretol (Carbamazepine) C Date:11/28/03ISR Number: 4257250-7Report Type:Periodic Company Report #USA030640040 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa Oral Insomnia (Olanzapine) PS Logorrhoea Zoloft (Sertraline Weight Increased Hydrochloride) C Date:11/28/03ISR Number: 4257252-0Report Type:Periodic Company Report #USA030640107 Age:62 YR Gender:Female I/FU:I Outcome PT Anorexia Muscle Tightness Nausea 24-Jun-2005 12:19 PM Page: 2609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Disturbance Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa Oral (Olanzapine) PS 10 MG/DAY 4 WK Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Seroquel (Quetiapine Fumarate) C Date:11/28/03ISR Number: 4257255-6Report Type:Periodic Company Report #USA030640119 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Prozac Prescribed Overdose (Fluoxetine Thinking Abnormal Hydrochloride) PS 120 MG/DAY Strattera (Atomoxetine Hydrochloride) SS 40 MG/DAY 12 DAY Zyprexa Oral (Olanzapine) SS 30 MG/DAY 1 YR Lithium C Wellbutrin (Bupropion Hydrochloride) C Date:11/28/03ISR Number: 4257260-XReport Type:Periodic Company Report #USA030640131 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa Professional Zydis-Dispersible Company (Olanzapine) PS 60 MG/DAY Representative Risperdal (Risperidone) C Date:11/28/03ISR Number: 4257265-9Report Type:Periodic Company Report #USA030640147 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Health Zyprexa Oral Neuroleptic Malignant Professional (Olanzapine) PS ORAL 30 MG/DAY 2 YR Syndrome Company Lamictal Posture Abnormal Representative (Lamotrigine) C Prescribed Overdose Date:11/28/03ISR Number: 4257267-2Report Type:Periodic Company Report #USA030640150 Age: Gender:Male I/FU:I Outcome PT Other Decreased Activity Disturbance In Attention Fatigue 24-Jun-2005 12:19 PM Page: 2610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypoglycaemia Ketoacidosis Stress Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa Oral (Olanzapine) PS 10 MG 1 YR Insulin, Regular C Insuline Ultralents (Insulin Zinc Suspension) C Prinivil (Lisinopril) C Date:11/28/03ISR Number: 4257269-6Report Type:Periodic Company Report #USA030640209 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Blistering Health Zyprexa Professional Zydis-Dispersible Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4257271-4Report Type:Periodic Company Report #USA030640217 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Zyprexa Conduction Disorder Professional (Olanzapine) PS 5 MG/AT Electrocardiogram St-T BEDTIME Change Date:11/28/03ISR Number: 4258649-5Report Type:Periodic Company Report #USA030537846 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 40 MG Representative Depakote (Valproate Semisodium) C Lithium C Date:11/28/03ISR Number: 4258652-5Report Type:Periodic Company Report #USA030537860 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa-Oral Tic Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Date:11/28/03ISR Number: 4258656-2Report Type:Periodic Company Report #USA030537901 Age: Gender:Female I/FU:I Outcome PT Report Source Constipation Health Vision Blurred Professional 24-Jun-2005 12:19 PM Page: 2611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/DAY Benzodiazepine C Date:11/28/03ISR Number: 4258660-4Report Type:Periodic Company Report #USA030537932 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa-Oral Decreased Appetite Professional (Olanzapine) Oedema Peripheral Company (Olanzapine) PS 2.5 MG/DAY Representative Hormone Replacement Therapy C Date:11/28/03ISR Number: 4258663-XReport Type:Periodic Company Report #USA030537976 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Health Zyprexa-Oral Hypersomnia Professional (Olanzapine) (Olanzapine) PS 5 MG/IN THE EVENING Aricept (Donepezil Hydrochloride) C Diovan (Valsartan) C Lipitor (Atorvastatin) C Lasix (Furosemide) C Potassium C Coreg (Carvedilol) C Coumadin (Warfarin Sodium) C Date:11/28/03ISR Number: 4258665-3Report Type:Periodic Company Report #USA030537978 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metabolic Disorder Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 2.5 MG/DAY Paxil (Paroxetine Hydrochloride) C Date:11/28/03ISR Number: 4258668-9Report Type:Periodic Company Report #USA030538041 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa-Oral Flat Affect Professional (Olanzapine) Prescribed Overdose Company (Olanzapine) PS 30 MG Representative Xanax (Alprazolam) C 24-Jun-2005 12:19 PM Page: 2612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4258671-9Report Type:Periodic Company Report #USA030538049 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Zyprexa-Oral Oedema Peripheral Health (Olanzapine) Weight Increased Professional (Olanzapine) PS 15 MG/DAY Concerta (Methylphenidate Hydrochloride) C Klonopin (Clonazepam) C Lithobid (Lithium Carbonate) C Minocycline C Nardil (Phenelzine Sulfate) C Topamax (Topiramate) C Date:11/28/03ISR Number: 4258674-4Report Type:Periodic Company Report #USA030538206 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Zyprexa-Oral Increased Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4258678-1Report Type:Periodic Company Report #USA030538217 Age:39 YR Gender:Male I/FU:I Outcome PT Bronchitis Conjunctivitis Delusion Delusion Of Grandeur Diabetes Mellitus Diarrhoea Difficulty In Walking Dizziness Dysuria Ear Infection Fatigue Flushing Hallucination, Auditory Heart Rate Irregular Hypersensitivity Hyperventilation Hypoglycaemia Mania Nausea Nervousness Obstructive Airways Disorder Oedema Peripheral Palpitations Pharyngitis Prescribed Overdose Psychotic Disorder Pyrexia 24-Jun-2005 12:19 PM Page: 2613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Sinusitis Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Therapeutic Agent Consumer Zyprexa-Oral Toxicity (Olanzapine) Urinary Retention (Olanzapine) PS 30 MG/AT Vision Blurred BEDTIME Vomiting Amoxicillin Weight Fluctuation Trihydrate/Clavulana te Potassium C Inderal (Propranolol Hydrochloride) C Keflex (Cefalexin Monohydrate) C Lithium C Dextromet./Diphenhyd r./Guaifenesin/Pseud oeph. C Medrol (Methylprednisolone) C Risperdal (Risperidone) C Valium (Diazepam) C Wellbutrin (Bupropion Hydrochloride) C Zithromax Z-Pack (Azithromycin) C Date:11/28/03ISR Number: 4258713-0Report Type:Periodic Company Report #USA030227618 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Health Zyprexa-Oral Loss Of Consciousness Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Diazepam C Date:11/28/03ISR Number: 4258715-4Report Type:Periodic Company Report #USA030228319 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Zyprexa-Oral Medication Error Professional (Olanzapine) Sedation (Olanzapine) PS 10 MG/DAY Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4258725-7Report Type:Periodic Company Report #USA030229051 Age:67 YR Gender:Male I/FU:I Outcome PT Feeling Abnormal Hallucination Insomnia Movement Disorder Muscle Spasms Pain In Extremity 24-Jun-2005 12:19 PM Page: 2614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Strattera (Atomoxetine Hydrochloride) PS 40 MG/1 DAY 4 DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/2 DAY 9 MON Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG/DAY Neurontin (Gabapentin) C Ambien (Zolpidem Tartrate) C Tylenol Pm C Date:11/28/03ISR Number: 4258728-2Report Type:Periodic Company Report #USA030229556 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Forteo Dyspepsia (Teriparatide) PS 20 UG/DAY Fear Zyprexa-Oral (Olanzapine) (Olanzapine) SS Centrum C Citracal (Calcium Citrate) C Estrogens Nos C Fibercon (Polycarbophil Calcium) C Folic Acid C Klonopin (Clonazepam) C Maxide C Paxil (Paroxetine Hydrochloride) C Protonix (Pantoprazole) C Bran C Stool Softener (Docusate Sodium) C Vitamin B1 C Vitamin B12 C Vitamin C C Vitamin E C Zestril (Lisinopril) C Date:11/28/03ISR Number: 4258733-6Report Type:Periodic Company Report #USA030229763 Age:81 YR Gender:Male I/FU:I Outcome PT Cognitive Disorder Decreased Appetite Difficulty In Walking 24-Jun-2005 12:19 PM Page: 2615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysstasia Fall Feeling Abnormal Report Source Product Role Manufacturer Route Dose Duration Head Injury Consumer Zyprexa-Oral Memory Impairment (Olanzapine) Mood Altered (Olanzapine) PS 10 MG 3 MON Sleep Disorder Valium (Diazepam) C Speech Disorder Weight Decreased Date:11/28/03ISR Number: 4258737-3Report Type:Periodic Company Report #USA030229998 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Consumer Zyprexa-Oral Mania (Olanzapine) Medication Tampering (Olanzapine) PS 2.5 MG Weight Decreased Trileptal Weight Increased (Oxcarbazepine) C Neurontin (Gabapentin) C Nardil (Phenelzine Sulfate) C Date:11/28/03ISR Number: 4258741-5Report Type:Periodic Company Report #USA030330731 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gestational Diabetes Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 7.5 MG/AT BEDTIME Levoxyl (Levothyroxine Sodium) C Ambien (Zolpidem Tartrate) C Date:11/28/03ISR Number: 4258742-7Report Type:Periodic Company Report #USA030330760 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Zyprexa-Oral Increased Professional (Olanzapine) Blood Triglycerides Company (Olanzapine) PS 3 MON Increased Representative High Density Lipoprotein Decreased Date:11/28/03ISR Number: 4258754-3Report Type:Periodic Company Report #USA030330939 Age:71 YR Gender:Female I/FU:I Outcome PT Diarrhoea Drug Ineffective Dyspepsia Fatigue 24-Jun-2005 12:19 PM Page: 2616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hunger Nervousness Somnolence Report Source Product Role Manufacturer Route Dose Duration Consumer Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG Premarin (Estrogens Conjugated) C Medroxyprogesterone C Date:11/28/03ISR Number: 4258755-5Report Type:Periodic Company Report #USA030332016 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypometabolism Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 7.5 MG/DAY Tums (Calcium Carbonate) C Magnesium C Ativan (Lorazepam) C Boric Acid C Date:11/28/03ISR Number: 4258759-2Report Type:Periodic Company Report #USA021022341 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa-Oral Feeling Abnormal (Olanzapine) Hangover (Olanzapine) PS 10 MG/1 DAY Increased Appetite Elonopin Somnolence (Clonazepam) C Weight Increased Alprazolam C Date:11/28/03ISR Number: 4258774-9Report Type:Periodic Company Report #USA021123427 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complication Of Delivery Health Zyprexa-Oral Pre-Eclampsia Professional (Olanzapine) Company (Olanzapine) PS Representative Effexor (Venlafaxine Hydrochloride) C Depakote (Valproate Semisodium) C Seroquel C Date:11/28/03ISR Number: 4258782-8Report Type:Periodic Company Report #USA021123743 Age:45 YR Gender:Male I/FU:I Outcome PT Other Blood Glucose Increased Diabetes Mellitus 24-Jun-2005 12:19 PM Page: 2617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Somnolence Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 15 MG/DAY Norvasc (Amlodipine Besilate) C Amaryl (Glimepiride) C Accupril (Quinapril Hydrochloride) C Date:11/28/03ISR Number: 4258785-3Report Type:Periodic Company Report #USA021224402 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa-Oral Back Pain (Olanzapine) Depression (Olanzapine) PS 15 MG/DAY Fibromyalgia Paxil (Paroxetine Food Craving Hydrochloride) C Hypertension Ativan (Lorazepam) C Weight Increased Flexeril (Cyclobenzapine Hydrochloride) C Date:11/28/03ISR Number: 4258799-3Report Type:Periodic Company Report #USA021224405 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Chest Sound Consumer Zyprexa-Oral Blood Glucose Decreased (Olanzapine) Confusional State (Olanzapine) PS 7.5 MG/DAY Drooling Insulin Novolin Hallucination 70/30 C Fluoxetine C Date:11/28/03ISR Number: 4258805-6Report Type:Periodic Company Report #USA021224484 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 35 MG/DAY Representative Ativan (Lorazepam) C Date:11/28/03ISR Number: 4258811-1Report Type:Periodic Company Report #USA021225324 Age:6 YR Gender:Male I/FU:I Outcome PT Abnormal Behaviour Dental Caries Difficulty In Walking Erection Increased Fracture Gastrooesophageal Reflux Disease 24-Jun-2005 12:19 PM Page: 2618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Helicobacter Infection Nystagmus Somnolence Report Source Product Role Manufacturer Route Dose Duration Tooth Loss Consumer Zyprexa-Oral Vision Blurred (Olanzapine) (Olanzapine) PS 2.5 MG/IN THE MORNING Date:11/28/03ISR Number: 4258819-6Report Type:Periodic Company Report #USA030125773 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Depakote (Valproate Semisodium) C Nexium (Esomeprazole) C Zoloft (Sertraline Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Date:11/28/03ISR Number: 4258820-2Report Type:Periodic Company Report #USA030126861 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Dysarthria (Atomoxetine Prescribed Overdose Hydrochloride) PS 40 MG/DAY 2 DAY Tremor Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG/2 DAY 1 YR Anafranil (Clomipramine Hydrochloride) C Ritalin (Methylphenidate Hydrochloride) C Avandia (Rosiglitazone Maleate) C Glucotrol (Glipizide) C Actos "Takeda" (Pioglitazone) C Date:11/28/03ISR Number: 4258822-6Report Type:Periodic Company Report #USA030127013 Age:15 YR Gender:Male I/FU:I Outcome PT Aggression Amnesia Blood Glucose Fluctuation Fear Hallucination 24-Jun-2005 12:19 PM Page: 2619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Judgement Impaired Paranoia Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Screaming Consumer Zyprexa-Oral Speech Disorder (Olanzapine) Thinking Abnormal (Olanzapine) PS 10 MG/DAY Vocal Cord Paralysis Wellbutrin Weight Decreased (Bupropion Weight Increased Hydrochloride) C Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Desyrel (Trazodone Hydrochloride) C Abilify (Aripiprazole) C Date:11/28/03ISR Number: 4258825-1Report Type:Periodic Company Report #USA030434346 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Oedema Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY 3 WK Representative Diltiazem C Lamictal (Lamotrigine) C Zanaflex (Tizanidine Hydrochloride) C Trazadone (Trazodone) C Celexa (Citalopram Hydrobromide) C Date:11/28/03ISR Number: 4258826-3Report Type:Periodic Company Report #USA030434375 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Craving Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 10 MG/DAY Fosamax (Alendronate Sodium) C Zocor (Simvastatin) C Imitrex (Sumatriptan Succinate) C Ambien (Zolpidem Tartrate) C Trazodone C Estratest C Zyrtec (Cetirizine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4258829-9Report Type:Periodic Company Report #USA030434496 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgeusia Consumer Zyprexa-Oral Hypoaesthesia (Olanzapine) (Olanzapine) PS 10 MG/AT BEDTIME Lexapro (Escitalopram) C Buspar (Buspirone Hydrochloride) C Multivitamin C Date:11/28/03ISR Number: 4258830-5Report Type:Periodic Company Report #USA030434512 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Jaw Disorder Health Zyprexa-Oral Tardive Dyskinesia Professional (Olanzapine) Company (Olanzapine) PS 22.5 MG/DAY Representative Depakote (Valproate Semisodium) C Seroquel (Quetiapine Fumarate) C Topamax (Topiramate) C Date:11/28/03ISR Number: 4258833-0Report Type:Periodic Company Report #US_021189780 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Engorgement Health Zyprexa-Oral Breast Tenderness Professional (Olanzapine) Prescribed Overdose (Olanzapine) PS 25 MG/DAY Seroquel C Topomax (Topiramate) C Date:11/28/03ISR Number: 4258835-4Report Type:Periodic Company Report #US_030292494 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Spontaneous Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/DAY Depakote (Valproate Semisodium) C Nexium (Esomeprazole) C Date:11/28/03ISR Number: 4258836-6Report Type:Periodic Company Report #US_030292648 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 30 MG/DAY Strattera (Atomoxetine 24-Jun-2005 12:19 PM Page: 2621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS 60 MG Date:11/28/03ISR Number: 4258839-1Report Type:Periodic Company Report #US_030393413 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Test False Health Zyprexa-Oral Positive Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4258842-1Report Type:Periodic Company Report #US_030393430 Age:0 MON Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Premature Baby Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Paxil (Paroxetine Hydrochloride) C Date:11/28/03ISR Number: 4258844-5Report Type:Periodic Company Report #US_030493752 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Other Zyprexa-Oral Difficulty In Walking (Olanzapine) Tremor (Olanzapine) PS Date:11/28/03ISR Number: 4258848-2Report Type:Periodic Company Report #US_030493836 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Zyprexa-Oral Ketoacidosis Professional (Olanzapine) Pancreatitis Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4258851-2Report Type:Periodic Company Report #US_030493862 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Coma Consumer Zyprexa-Oral Diabetic Ketoacidosis (Olanzapine) Pancreatitis (Olanzapine) PS Date:11/28/03ISR Number: 4258852-4Report Type:Periodic Company Report #US_030493883 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa-Oral Dementia Alzheimer'S Type Other (Olanzapine) Depression (Olanzapine) PS Suicide Attempt Unevaluable Event 24-Jun-2005 12:19 PM Page: 2622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4258854-8Report Type:Periodic Company Report #US_030493927 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Zyprexa-Oral Phosphatase Increased Professional (Olanzapine) Hyperkeratosis Company (Olanzapine) PS 40 MG/2 DAY Lethargy Representative Medication Error Pain In Extremity Prescribed Overdose Somnolence Date:11/28/03ISR Number: 4258857-3Report Type:Periodic Company Report #US_010158681 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa-Oral Balance Disorder (Olanzapine) Cerebrovascular Accident (Olanzapine) PS 20 MG/DAY Chest Pain Prolixin Drug Tolerance Decreased (Fluphenazine Feeling Abnormal Hydrochloride) C Insomnia Prolixin Lymph Node Pain (Fluphenazine Memory Impairment Hydrochloride) C Nausea Pain In Extremity Rectal Tenesmus Somnolence Weight Increased Date:11/28/03ISR Number: 4258860-3Report Type:Periodic Company Report #US_010362009 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Consumer Zyprexa-Oral Increased (Olanzapine) Drug Ineffective (Olanzapine) PS 30 MG/1 DAY Prescribed Overdose Prozac-Oral Swelling (Fluoxetine Weight Decreased (Fluoxetine Hydrochloride) SS 80 MG/1 DAY 7 YR Buspar (Buspirone Hydrochloride) C Navane (Tiotixene) C Clonopin (Clonazepam) C Date:11/28/03ISR Number: 4258861-5Report Type:Periodic Company Report #US_010464556 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Buccoglossal Syndrome Health Zyprexa-Oral Drug Ineffective Professional (Olanzapine) Mania (Olanzapine) PS 10 MG/2 DAY 11 MON Tremor Tegretol Weight Increased (Carbamazepine) C Eskalith Cr (Lithium 24-Jun-2005 12:19 PM Page: 2623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbonate) C Prevacid (Lansoprazole) C Date:11/28/03ISR Number: 4258867-6Report Type:Periodic Company Report #US_010565854 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Consumer Zyprexa-Oral Depression Other (Olanzapine) Heart Rate Increased (Olanzapine) PS 20 MG/DAY Nervousness Zyprexa Restlessness Zydis-Dispersible Thyroid Function Test (Olanzapine) Abnormal (Olanzapine) SS 10 MG/DAY Vomiting Thyroiid C Weight Increased Celexa (Citalopram Hydrobromide) C Zoloft (Sertraline Hydrochloride) C Neurontin (Gabapentin) C Serzone (Nefazodone Hydrochloride) C Ativan (Lorazepam) C Levothroid (Levothyroxine Sodium) C Doxepin C Paxil (Paroxetine Hydrochloride) C Vitamin E C Date:11/28/03ISR Number: 4258871-8Report Type:Periodic Company Report #US_010565932 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa-Oral Delusion (Olanzapine) Depression (Olanzapine) PS 15 MG/DAY Drug Ineffective Norvasc (Amlodipine Hallucination Besilate) C Hostility Increased Appetite Panic Attack Paranoia Psychotic Disorder Respiratory Tract Infection Social Avoidant Behaviour Date:11/28/03ISR Number: 4258872-XReport Type:Periodic Company Report #US_011177131 Age:43 YR Gender:Female I/FU:I Outcome PT Other Aura Complex Partial Seizures Drug Effect Decreased Grand Mal Convulsion 24-Jun-2005 12:19 PM Page: 2624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/IN THE EVENING Cogentin (Benzatropine Mesilate) C Zoloft (Sertraline Hydrochloride) C Depakote (Valproate Semisodium) C Tegretol (Carbamazepine) C Seroquel (Quetiapine Fumarate) C Date:11/28/03ISR Number: 4258873-1Report Type:Periodic Company Report #US_020685031 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Consumer Zyprexa-Oral Headache (Olanzapine) Muscle Rigidity (Olanzapine) PS 20 MG Pain Pain In Extremity Toothache Weight Increased Date:11/28/03ISR Number: 4258874-3Report Type:Periodic Company Report #US_020886671 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa-Oral Sleep Disorder Professional (Olanzapine) Tardive Dyskinesia (Olanzapine) PS 5 MG/DAY Weight Increased Tranylcypromine C Weight Loss Poor Adderall C Date:11/28/03ISR Number: 4258875-5Report Type:Periodic Company Report #US_020987663 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa-Oral Depression Professional (Olanzapine) Company (Olanzapine) PS 10 MG/2 DAY Representative Paxil (Paroxetine Hydrochloride) C Date:11/28/03ISR Number: 4258880-9Report Type:Periodic Company Report #USA030946556 Age: Gender:Female I/FU:I Outcome PT Report Source Muscle Rigidity Health Professional 24-Jun-2005 12:19 PM Page: 2625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 15 MG Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4258886-XReport Type:Periodic Company Report #USA030946558 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Agent Consumer Zyprexa-Oral Toxicity (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4258889-5Report Type:Periodic Company Report #USA030946561 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Health Zyprexa-Oral Dehydration Professional (Olanzapine) Weight Decreased (Olanzapine) PS 5 MG/1 DAY Weight Increased Quetiapine C Lexapro (Escitalopram) C Date:11/28/03ISR Number: 4258893-7Report Type:Periodic Company Report #USA030946593 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa-Oral Dyspnoea (Olanzapine) Mental Disorder (Olanzapine) PS 15 MG/DAY Nervousness Topamax (Topiramate) C Panic Disorder Psychotic Disorder Tremor Vertigo Vision Blurred Weight Decreased Date:11/28/03ISR Number: 4258895-0Report Type:Periodic Company Report #USA030946612 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa-Oral Pericardial Effusion Professional (Olanzapine) Pulmonary Oedema Company (Olanzapine) PS 20 MG/DAY Representative Depakote (Valproate Semisodium) C Klonopin(Clonazepam) C 24-Jun-2005 12:19 PM Page: 2626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4258896-2Report Type:Periodic Company Report #USA030946616 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Consumer Zyprexa-Oral Loss Of Consciousness (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4258897-4Report Type:Periodic Company Report #USA030946666 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Agitation (Olanzapine) Aphasia (Olanzapine) PS 30 MG/DAY Arthralgia Clozaril (Clozapine) C Communication Disorder Depakote (Valproate Confusional State Semisodium) C Dizziness Risperdal Exophthalmos (Risperidone) C Fatigue Cogentin Hyperhidrosis (Benzatropine Hypersomnia Mesilate) C Insomnia Musculoskeletal Stiffness Prescribed Overdose Restlessness Thirst Tremor Date:11/28/03ISR Number: 4258898-6Report Type:Periodic Company Report #USA030946700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa-Oral Glycosylated Haemoglobin Professional (Olanzapine) Increased Company (Olanzapine) PS 10 MG/DAY Representative Date:11/28/03ISR Number: 4258899-8Report Type:Periodic Company Report #USA030946718 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa-Oral Somnolence Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Date:11/28/03ISR Number: 4258900-1Report Type:Periodic Company Report #USA030946856 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Craving Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 10 MG Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4258901-3Report Type:Periodic Company Report #USA030946872 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 25 MG/AT Representative BEDTIME Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4258902-5Report Type:Periodic Company Report #USA030946954 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4258903-7Report Type:Periodic Company Report #USA030946985 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Zyprexa-Oral Pituitary Enlargement Professional (Olanzapine) Weight Increased (Olanzapine) PS 10 MG Topamax (Topiramate) C Date:11/28/03ISR Number: 4258904-9Report Type:Periodic Company Report #USA030947151 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Musculoskeletal Stiffness (Olanzapine) Oedema (Olanzapine) PS 2.5 MG/DAY Weight Increased Ferrous Sulfate C Lexapro C Advair C Date:11/28/03ISR Number: 4258905-0Report Type:Periodic Company Report #USA030947174 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Health Zyprexa-Oral Apathy Professional (Olanzapine) Bradyphrenia Company (Olanzapine) PS 10 MG Irritability Representative Oedema Peripheral Swollen Tongue Date:11/28/03ISR Number: 4258906-2Report Type:Periodic Company Report #USA030947239 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Consumer Zyprexa-Oral Treatment Noncompliance (Olanzapine) (Olanzapine) PS 25 MG 24-Jun-2005 12:19 PM Page: 2628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa Zydis-Dispersible (Olanzapine) (Olanzapine) SS Risperidone C Date:11/28/03ISR Number: 4258907-4Report Type:Periodic Company Report #USA030947299 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Erosion Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 7.5 MG/DAY Luvox (Fluvoxamine Maleate) C Date:11/28/03ISR Number: 4258908-6Report Type:Periodic Company Report #USA030947301 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4258909-8Report Type:Periodic Company Report #USA030947450 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Health Zyprexa-Oral Blood Glucose Decreased Professional (Olanzapine) Blood Glucose Increased Company (Olanzapine) PS 40 MG/DAY Dizziness Representative Risperal Incoherent (Risperidone) C Insulin Resistance Wellbutrin Prescribed Overdose (Bupropion) C Lithium C Neurontin (Gabapentin) C Valium (Diazepam) C Metformin C Actos "Takeda" (Pioglitazone) C Date:11/28/03ISR Number: 4258910-4Report Type:Periodic Company Report #USA030947532 Age:81 YR Gender:Male I/FU:I Outcome PT Anxiety Aphasia Blood Urea Increased Contusion Dementia Extrapyramidal Disorder Gamma-Glutamyltransferase Increased Gastrooesophageal Reflux 24-Jun-2005 12:19 PM Page: 2629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disease Hyperhidrosis Impaired Healing Insomnia Report Source Product Role Manufacturer Route Dose Duration Muscular Weakness Health Zyprexa-Oral Nervousness Professional (Olanzapine) Pruritus User Facility (Olanzapine) PS 10 MG/DAY Rash Maculo-Papular Prozac-Oral Rhinorrhoea (Fluoxetine) SS Vomiting Fluoxetine Hydrochloride C Aldactone (Spironolactone) C Demadex (Torasemide) C Date:11/28/03ISR Number: 4258911-6Report Type:Periodic Company Report #USA030947597 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) PS 25 MG/DAY Company Representative Date:11/28/03ISR Number: 4258912-8Report Type:Periodic Company Report #USA030947722 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hormone Level Abnormal Consumer Zyprexa-Oral Oligomenorrhoea (Olanzapine) Somnolence (Olanzapine) PS 5 MG/ AT Weight Increased BEDTIME Bextra (Valdecoxib) C Date:11/28/03ISR Number: 4258913-XReport Type:Periodic Company Report #USA030947729 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa-Oral Gastroenteritis Viral Professional (Olanzapine) Lung Disorder Company (Olanzapine) PS 20 MG/DAY Restlessness Representative Serzone (Nefazodone Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4258914-1Report Type:Periodic Company Report #USA030947745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4258915-3Report Type:Periodic Company Report #USA030947779 Age:85 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa-Oral Musculoskeletal Stiffness Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Celexa (Citalopram Hydrobromide) C Date:11/28/03ISR Number: 4258916-5Report Type:Periodic Company Report #USA030948002 Age:9 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Zyrtec (Cetirizine Hydrochloride) C Date:11/28/03ISR Number: 4258917-7Report Type:Periodic Company Report #USA030948022 Age:21 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa Professional Zydis-Dispersible (Olanzapine) (Olanzapine) PS 15 MG / IN THE EVENING Wellbutrin (Bupropion Hydrochloride) C Date:11/28/03ISR Number: 4258918-9Report Type:Periodic Company Report #USA030948024 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Hypertrophy Breast (Olanzapine) Loss Of Libido (Olanzapine) PS ORAL ORAL Weight Increased Prozac - Oral (Fluoxetine) SS Cholesterol C Vitamins Nos C Fluoxetine Hydrochloride C Date:11/28/03ISR Number: 4258919-0Report Type:Periodic Company Report #USA030948161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259087-1Report Type:Periodic Company Report #USA030742860 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Buccoglossal Syndrome Health Zyprexa-Oral Dry Mouth Professional (Olanzapine) Hemiparesis Company (Olanzapine) PS 30 MG/DAY Nausea Representative Prozac-Oral Prescribed Overdose (Fluoxetine ) Visual Disturbance (Fluoxetine Hydrochloride) SS 20 MG/DAY Date:11/28/03ISR Number: 4259089-5Report Type:Periodic Company Report #USA030742878 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259091-3Report Type:Periodic Company Report #USA030842995 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Date:11/28/03ISR Number: 4259092-5Report Type:Periodic Company Report #USA030843107 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Consumer Zyprexa-Oral Dysuria (Olanzapine) Nocturia (Olanzapine) PS 10 MG/AT Urinary Hesitation BEDTIME Ambien (Zolpidem Tablets) C Duragesic (Fentanyl) C Effexor (Venlafaxine Hydrochloride) C Lipitor (Atorvastatin) C Percocet C Valium (Diazepam) C Zanaflex (Tizanidine Hydrochloride) C Date:11/28/03ISR Number: 4259094-9Report Type:Periodic Company Report #USA030843122 Age: Gender:Female I/FU:I Outcome PT Depression Feeling Abnormal Mania Nausea 24-Jun-2005 12:19 PM Page: 2632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panic Attack Weight Increased Weight Loss Poor Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 15 MG/IN THE EVENING Imipramine C Klonopin (Clonazepam) C Lamictal (Lamotrigine) C Lexapro (Escitalopram) C Date:11/28/03ISR Number: 4259095-0Report Type:Periodic Company Report #USA030843132 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypermetabolism Health Zyprexa-Oral Weight Decreased Professional (Olanzapine) (Olanzapine) PS 1.25 MG/2 DAY Lamictal (Lamotrigine) C Date:11/28/03ISR Number: 4259097-4Report Type:Periodic Company Report #USA030843141 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Ketoacidosis (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4259098-6Report Type:Periodic Company Report #USA030843193 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Discolouration Health Zyprexa Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS 5 MG Date:11/28/03ISR Number: 4259100-1Report Type:Periodic Company Report #USA030843214 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259101-3Report Type:Periodic Company Report #USA030843222 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa-Oral Prescribed Overdose (Olanzapine) Weight Increased (Olanzapine) PS 70 MG/DAY Risperdal (Risperidone) C Date:11/28/03ISR Number: 4259102-5Report Type:Periodic Company Report #USA030740818 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Weight Increased Professional (Olanzapine) PS 30 MG/DAY Company Haldol Decanoate Representative (Haloperidol Decanoate) C Date:11/28/03ISR Number: 4259103-7Report Type:Periodic Company Report #USA030740837 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:11/28/03ISR Number: 4259104-9Report Type:Periodic Company Report #USA030740840 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Medication Error (Olanzapine) PS 20 MG/IN THE EVENING Klonopin (Clonazepam) C Neurontin (Gabapentin) C Seroquel (Quetiapine Fumarate) C Date:11/28/03ISR Number: 4259105-0Report Type:Periodic Company Report #USA030740854 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa-Oral Vision Blurred Professional (Olanzapine) PS 20 MG/DAY Visual Disturbance Company Lithium C Representative Effexor (Venlafaxine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259106-2Report Type:Periodic Company Report #USA030740931 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Zyprexa-Oral Confusional State (Olanzapine) PS 20 MG/DAY Hostility Wellbutrin Mental Impairment (Bupropion Thinking Abnormal Hydrochloride) C Strattera C Date:11/28/03ISR Number: 4259107-4Report Type:Periodic Company Report #USA030740932 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Binge Eating Consumer Zyprexa-Oral Feeling Hot (Olanzapine) PS Headache Prozac (Fluoxetine Increased Appetite Hydrochloride) C Weight Increased Neurontin (Gabapentin) C Date:11/28/03ISR Number: 4259108-6Report Type:Periodic Company Report #USA030740982 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:11/28/03ISR Number: 4259110-4Report Type:Periodic Company Report #USA030741002 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:11/28/03ISR Number: 4259111-6Report Type:Periodic Company Report #USA030741015 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa-Oral Professional (Olanzapine) PS 4 DAY Company Representative Date:11/28/03ISR Number: 4259113-XReport Type:Periodic Company Report #USA030741079 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Zyprexa-Oral Increased Professional (Olanzapine) PS Blood Triglycerides Paxil (Paroxetine Increased Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259115-3Report Type:Periodic Company Report #USA030843291 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Zyprexa-Oral Implantable Defibrillator Professional (Olanzapine) Malfunction Company (Olanzapine) PS 2.5 MG/DAY Representative Zocor (Simvastatin) C Lexapro (Escitalopram) C Date:11/28/03ISR Number: 4259116-5Report Type:Periodic Company Report #USA030843301 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyslipidaemia Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Zoloft (Sertraline Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Date:11/28/03ISR Number: 4259117-7Report Type:Periodic Company Report #USA030843314 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Zyprexa-Oral Syncope Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259119-0Report Type:Periodic Company Report #USA030843347 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Strattera Professional (Atomoxetine Company Hydrochloride) PS 10 MG/DAY 2 WK Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS Adderall C Lithium C Trileptal (Oxcarbazepine) C Date:11/28/03ISR Number: 4259120-7Report Type:Periodic Company Report #USA030843373 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intubation Health Zyprexa-Oral Loss Of Consciousness Professional (Olanzapine) Overdose Company (Olanzapine) PS 140 MG Representative Straterra (Atomoxetine Hydrochloride) SS 3280 MG 24-Jun-2005 12:19 PM Page: 2636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259122-0Report Type:Periodic Company Report #USA030843375 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG 1 MON Representative Toprol Xl (Metoprolol Succinate) C Depakote (Valproate Semisodium) C Imitrex (Sumatriptan Succinate) C Norvasc (Amlodipine Besilate) C Lexapro (Escitalopram) C Topamax (Topiramate) C Date:11/28/03ISR Number: 4259124-4Report Type:Periodic Company Report #USA030843508 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Hypoglycaemia Professional (Olanzapine) Company (Olanzapine) PS Representative Lithium C Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4259126-8Report Type:Periodic Company Report #USA030843514 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Straterra Feeling Abnormal (Atomoxetine Hypersomnia Hydrochloride) PS 40 MG/IN THE Initial Insomnia MORNING Lethargy Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG/AT BEDTIME Lithium C Date:11/28/03ISR Number: 4259127-XReport Type:Periodic Company Report #USA030843523 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Consumer Zyprexa-Oral Chest Discomfort (Olanzapine) Confusional State (Olanzapine) PS 5 MG Zoloft (Sertraline Hydrochloride) C Toprol Xl (Metoprolol Succinate) C Maxzide C Lisinopril C 24-Jun-2005 12:19 PM Page: 2637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zocor (Simvastatin) C Colace (Docusate Sodium) C Date:11/28/03ISR Number: 4259128-1Report Type:Periodic Company Report #USA030843540 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Celexa (Citalopram Hydrobromide) C Lithium C Wellbutrin (Bupropion Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Date:11/28/03ISR Number: 4259130-XReport Type:Periodic Company Report #USA030843556 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Consumer Zyprexa-Oral Dyskinesia (Olanzapine) Feeling Abnormal (Olanzapine) PS Speech Disorder Thinking Abnormal Tremor Date:11/28/03ISR Number: 4259132-3Report Type:Periodic Company Report #USA030843617 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Zyprexa-Oral Increased Professional (Olanzapine) Pancreatitis Company (Olanzapine) PS Representative Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4259134-7Report Type:Periodic Company Report #USA030843683 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphemia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259137-2Report Type:Periodic Company Report #USA030843717 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Health Zyprexa-Oral Somnolence Professional (Olanzapine) 24-Jun-2005 12:19 PM Page: 2638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS Date:11/28/03ISR Number: 4259139-6Report Type:Periodic Company Report #USA030843845 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Consumer Zyprexa-Oral Eye Pain (Olanzapine) Keratoconjunctivitis (Olanzapine) PS Sicca Midardis C Ocular Hyperaemia Atenolol C Lipitor (Atorvastatin) C Klor-Con (Potassium Chloride) C Lasix (Furosemide) C Zoloft (Sertraline Hydrochloride) C Premarin (Estrogesn Conjugated) C Vicodin C Voltaren (Diclofenac Sodium) C Klonopin (Clonazepam) C Aciflux C Date:11/28/03ISR Number: 4259140-2Report Type:Periodic Company Report #USA030843902 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259141-4Report Type:Periodic Company Report #USA030843947 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Disorientation (Olanzapine) Disturbance In Attention (Olanzapine) PS 5 MG/DAY Feeling Abnormal Remereon Gait Disturbance (Mirtazapine) C Psychomotor Skills Impaired Somnolence Date:11/28/03ISR Number: 4259143-8Report Type:Periodic Company Report #USA030843994 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa-Oral Abnormal Professional (Olanzapine) Neuroleptic Malignant Company (Olanzapine) PS Syndrome Representative 24-Jun-2005 12:19 PM Page: 2639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259144-XReport Type:Periodic Company Report #USA030844063 Age:5 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4259146-3Report Type:Periodic Company Report #USA030844152 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hair Growth Abnormal Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Adderall C Trazadone C Date:11/28/03ISR Number: 4259169-4Report Type:Periodic Company Report #USA030844188 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Luteinising Hormone Health Zyprexa-Oral Decreased Professional (Olanzapine) Haemoglobin Increased (Olanzapine) PS 5 MG/DAY Monocyte Count Decreased Wellbutrin (Bupropion Hydrochloride) C Aspirin C Methimazole C Date:11/28/03ISR Number: 4259171-2Report Type:Periodic Company Report #USA030844193 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Strattera Psychomotor Hyperactivity Professional (Atomoxetine Upper Limb Fracture Company Hydrochloride) PS 4 DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG/DAY Date:11/28/03ISR Number: 4259173-6Report Type:Periodic Company Report #USA030844227 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 15 MG/DAY Neurontin (Gabapentin) C Risperdal (Risperidone) C Clonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 2640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259174-8Report Type:Periodic Company Report #USA030844272 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa-Oral Temperature Intolerance (Olanzapine) Weight (Olanzapine) PS 20 MG/DAY Protonix (Pantoprazole) C Date:11/28/03ISR Number: 4259175-XReport Type:Periodic Company Report #USA030844274 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4259177-3Report Type:Periodic Company Report #USA030844295 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa Weight Increased Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS 10 MG/DAY 2 WK Risperdal (Riperidone) C Date:11/28/03ISR Number: 4259179-7Report Type:Periodic Company Report #USA030844350 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa Alcoholism Professional Zydis-Dispersible Anger Company (Olanzapine) Dementia Representative (Olanzapine) PS 10 MG Paradoxical Drug Reaction Quetiapine C Schizophrenia Hydroxyzine C Vicodin C Date:11/28/03ISR Number: 4259180-3Report Type:Periodic Company Report #USA030844450 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Zyprexa-Oral Drug Level Increased Professional (Olanzapine) Prescribed Overdose (Olanzapine) PS 45 MG/DAY Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4259182-7Report Type:Periodic Company Report #USA030844501 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Hypersomnia (Olanzapine) 24-Jun-2005 12:19 PM Page: 2641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS 2.5 MG/IN THE EVENING Date:11/28/03ISR Number: 4259184-0Report Type:Periodic Company Report #USA030844577 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa-Oral Syndrome Professional (Olanzapine) Company (Olanzapine) PS 20 MG/1 DAY Representative Lithium C Depakote (Valproate Semisodium) C Inderal (Propranolol Hydrochloride) C Lasix (Furosemide) C Potassium C Date:11/28/03ISR Number: 4259185-2Report Type:Periodic Company Report #US_030695141 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG/DAY Date:11/28/03ISR Number: 4259188-8Report Type:Periodic Company Report #US_030695214 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG/DAY Lorazepam C Solu-Medrol (Methylprednisolone Sodium Succinate) C Acetaminophen C Reglan (Metoclopramide) C Haley'S M O C Catapres )Clonidine) C Cogentin (Benzatropine Mesilate) C Norvasc (Amlodipine Besilate) C Avelox (Moxifloxacin Hydrochloride) C Rocephin (Ceftriaxone Sodium) C Protonix (Pantoprazole) C Tpn (Total Parenteral Nutrition) C Lipid Emulsion C 24-Jun-2005 12:19 PM Page: 2642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259190-6Report Type:Periodic Company Report #US_030695224 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Zyprexa-Oral Feeling Jittery (Olanzapine) Impatience (Olanzapine) PS 20 MG/DAY Irritability Wellbutrin Tremor (Bupropion Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Seroquel Quetiapine Fumarate) C Date:11/28/03ISR Number: 4259192-XReport Type:Periodic Company Report #US_030695230 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 5 MG Date:11/28/03ISR Number: 4259194-3Report Type:Periodic Company Report #US_030695311 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259195-5Report Type:Periodic Company Report #US_030695315 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Date:11/28/03ISR Number: 4259197-9Report Type:Periodic Company Report #US_030695550 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa-Oral Nightmare (Olanzapine) Weight Increased (Olanzapine) PS Date:11/28/03ISR Number: 4259198-0Report Type:Periodic Company Report #US_030795894 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Consumer Zyprexa-Oral Personality Disorder (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259201-8Report Type:Periodic Company Report #US_030796047 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa-Oral Agitation Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Aricept (Donepezil Hydrochloride) C Date:11/28/03ISR Number: 4259202-XReport Type:Periodic Company Report #US_030796481 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa-Oral Abnormal Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Date:11/28/03ISR Number: 4259211-0Report Type:Periodic Company Report #US_030796483 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa-Oral Feeling Abnormal (Olanzapine) (Olanzapine) PS 10 MG Dilantin (Phenytoin Sodium) C Zarontin (Ethosuximide) C Depakote (Valproate Semisodium) C Aspirin C Date:11/28/03ISR Number: 4259212-2Report Type:Periodic Company Report #US_030896998 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Consumer Zyprexa-Oral Sedation (Olanzapine) (Olanzapine) PS Zyrtec (Cetirizine Hydrochloride) C Date:11/28/03ISR Number: 4259214-6Report Type:Periodic Company Report #US_030897085 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glucose Tolerance Health Zyprexa-Oral Impaired Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 10 MG/DAY Representative Zoloft (Sertraline Hydrochloride) C Xanax (Alprazolam) C Daypro (Oxaprozin) C 24-Jun-2005 12:19 PM Page: 2644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259215-8Report Type:Periodic Company Report #US_030897117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hearing Impaired Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4259220-1Report Type:Periodic Company Report #US_030897120 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 22.5 MG/DAY Representative Clonazepam C Temazepam C Date:11/28/03ISR Number: 4259221-3Report Type:Periodic Company Report #US_030897122 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Motor Dysfunction Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Celexa (Citalopram Hydrobromide) C Date:11/28/03ISR Number: 4259222-5Report Type:Periodic Company Report #US_030897248 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Consumer Zyprexa-Oral Consciousness Company (Olanzapine) Intentional Misuse Representative (Olanzapine) PS Date:11/28/03ISR Number: 4259223-7Report Type:Periodic Company Report #US_030897251 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Zyprexa-Oral Intentional Misuse Company (Olanzapine) Representative (Olanzapine) PS Date:11/28/03ISR Number: 4259224-9Report Type:Periodic Company Report #US_030897253 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Consumer Zyprexa-Oral Loss Of Consciousness Company (Olanzapine) Representative (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259225-0Report Type:Periodic Company Report #US_030897254 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Zyprexa-Oral Intentional Misuse Company (Olanzapine) Representative (Olanzapine) PS Date:11/28/03ISR Number: 4259226-2Report Type:Periodic Company Report #USA030741788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259227-4Report Type:Periodic Company Report #USA030741791 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259228-6Report Type:Periodic Company Report #USA030741794 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259230-4Report Type:Periodic Company Report #USA030741795 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Strattera Hyperventilation Professional (Atomoxetine Somnolence Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS Date:11/28/03ISR Number: 4259231-6Report Type:Periodic Company Report #USA030741844 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Health Zyprexa-Oral Lethargy Professional (Olanzapine) Company (Olanzapine) PS OTHER 2.5 MG/OTHER 1 DAY Representative 24-Jun-2005 12:19 PM Page: 2646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259233-XReport Type:Periodic Company Report #USA030741854 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oral Candidiasis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:11/28/03ISR Number: 4259234-1Report Type:Periodic Company Report #USA030741883 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Dysuria (Olanzapine) PS 25 MG/DAY Glucose Urine Present Depakote (Valproate Prescribed Overdose Semisodium) C Weight Increased Neurontin (Gabapentin) C Buspar (Buspirone Hydrochloride) C Ambiem (Zolpidem Tartrate) C Klonopin (Clonazepam) C Date:11/28/03ISR Number: 4259236-5Report Type:Periodic Company Report #USA030741901 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 30 MG/DAY Representative Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4259237-7Report Type:Periodic Company Report #USA030741937 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa-Oral Inadequate Control Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 10 MG Representative Date:11/28/03ISR Number: 4259239-0Report Type:Periodic Company Report #USA030741954 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Diabetic Ketoacidosis Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative 24-Jun-2005 12:19 PM Page: 2647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259240-7Report Type:Periodic Company Report #USA030741976 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa-Oral Tremor Professional (Olanzapine) Weight Increased (Olanzapine) PS 10 MG/2 DAY Zyprexa Zydis-Dispersible(Ol anzapine) SS 10 MG/2 DAY Trazadone(Trazadone) C Topamax (Topiramate) C Ativan(Lorazepam) C Date:11/28/03ISR Number: 4259242-0Report Type:Periodic Company Report #USA030742039 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hunger Consumer Zyprexa-Oral Prescribed Overdose (Olanzapine) Rhinitis (Olanzapine) PS 25 MG/DAY Weight Increased Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/DAY Prozac Weekly -Oral (Fluoxetine(Fluoxeti ne Hydroch SS 90 MG/2 WEEK Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Date:11/28/03ISR Number: 4259243-2Report Type:Periodic Company Report #USA030742043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Fluctuating Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG Dilantin (Phenytoin Sodium) C Diazepam C Lamictal (Lamotrigine) C Date:11/28/03ISR Number: 4259245-6Report Type:Periodic Company Report #USA030742164 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Disorder Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259246-8Report Type:Periodic Company Report #USA030742168 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Disorder Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4259250-XReport Type:Periodic Company Report #USA030742181 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259252-3Report Type:Periodic Company Report #USA030742268 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Aggression (Olanzapine) PS Hostility Strattera C Mania Wellbutrin Mydriasis (Bupropion Somnolence Hydrochloride) C Suicide Attempt Depakote (Valproate Thinking Abnormal Semisodium) C Weight Increased Abilify (Aripiprazole) C Date:11/28/03ISR Number: 4259253-5Report Type:Periodic Company Report #USA030742290 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Craving Consumer Zyprexa-Oral Increased Appetite (Olanzapine) Somnolence (Olanzapine) PS 5MG/AT Weight Increased BEDTIME Prozac (Fluoxetine Hydrochloride) C . C Depakote (Valproate Semisodium) C Neurontin (Gabapentin) C Geodon (Ziprasidone Hydrochloride) C Seroquel (Quetiapine Fumarate0 C Ortho-Novum 7/7/7 C 24-Jun-2005 12:19 PM Page: 2649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259255-9Report Type:Periodic Company Report #USA030742366 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mouth Ulceration Health Zyprexa-Oral Tongue Disorder Professional (Olanzapine) (Olanzapine) PS 2.5 MG Imipramine C Buspar (Buspirone Hydrochloride0 C Clonazepam C Sonata C Date:11/28/03ISR Number: 4259257-2Report Type:Periodic Company Report #USA030742429 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Consumer Strattera Dysphonia (Atomoxetine Feeling Abnormal Hydrochloride) PS 60 MG /DAY Hypersomnia Zyprexa-Oral Listless (Olanzapine) SS 5 MG/BID DAY Sluggishness Concerta Tongue Disorder (Methylphenidate Hydrochloride) C Depakote (Valproate Semisodium) C .. C .. C ,.. C .. C Date:11/28/03ISR Number: 4259258-4Report Type:Periodic Company Report #USA030742446 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Consumer Zyprexa Tremor (Olanzapine) PS ORAL 60 MG/DAY Weight Increased Prozac (Fluxetine Hydrochloride) C ORAL Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4259262-6Report Type:Periodic Company Report #USA030742447 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Health Zyprexa Consciousness Professional (Olanzapine) PS ORAL 15 MG/2 DAY Feeling Drunk Prescribed Overdose Weight Decreased 24-Jun-2005 12:19 PM Page: 2650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259264-XReport Type:Periodic Company Report #USA030742468 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Consumer Zyprexa Health (Olanzapine) PS ORAL 10 MG/IN THE Professional EVENING Date:11/28/03ISR Number: 4259265-1Report Type:Periodic Company Report #USA030742481 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa Tardive Dyskinesia Professional (Olanzapine) PS ORAL 30 MG/DAY Trilafon (Perphenazine) C ORAL Date:11/28/03ISR Number: 4259267-5Report Type:Periodic Company Report #USA030742499 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gestational Diabetes Health Zyprexa Professional (Olanzapine) PS ORAL 20 MG/DAY Date:11/28/03ISR Number: 4259269-9Report Type:Periodic Company Report #USA030742547 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Hyperhidrosis (Olanzapine) Road Traffic Accident (Olanzapine) PS Somnolence Strattera Visual Acuity Reduced (Atomoxetine Hydrochloride) SS 25 MG/ DAY Depakote(Valproate Semisodium) C Date:11/28/03ISR Number: 4259270-5Report Type:Periodic Company Report #USA030742585 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Health Zyprexa Hypoaesthesia Professional Olanzapine) PS ORAL 10 MG/DAY Speech Disorder Date:11/28/03ISR Number: 4259271-7Report Type:Periodic Company Report #USA030742689 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zyprexa Intentional Misuse Professional Company (Olanzapine) PS ORAL 2.5 MG/9 DAY Representative Prozac (Fluoxetine Hydrochloride) SS ORAL 100 MG/DAY Depakote (Valproate Semisodium0 C 24-Jun-2005 12:19 PM Page: 2651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259273-0Report Type:Periodic Company Report #USA030742699 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Zyprexa Professional (Olanzapine) PS ORAL Company Representative Date:11/28/03ISR Number: 4259274-2Report Type:Periodic Company Report #USA030742850 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa Professional Company (Olanzapine) PS ORAL Representative Date:11/28/03ISR Number: 4259277-8Report Type:Periodic Company Report #USA030332240 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Prozac Drug Ineffective (Fluoxetine Somnolence Hydrochloride) PS ORAL 20 MG/ DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG/3 DAY Date:11/28/03ISR Number: 4259279-1Report Type:Periodic Company Report #USA030332288 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa Syndrome Professional (Olanzapine) PS ORAL 5 MG/DAY Dexedrine(Dexamfetam ine Sulfate0 C Lithium C Date:11/28/03ISR Number: 4259281-XReport Type:Periodic Company Report #USA030332460 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Zyprexa Anxiety (Olanzapine) PS 1.25 MG/AT Blood Cholesterol BEDTIME Increased Prozac (Fluoxetine Confusional State Hydrochloride) SS ORAL Depression Synthroid(Levothyrox Discomfort ine Sodium) C Dizziness Diltiazem C Fear Lipitor C Feeling Abnormal Aspirin C Headache Clonazem C Hunger Insomnia Nausea Oral Discomfort 24-Jun-2005 12:19 PM Page: 2652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259282-1Report Type:Periodic Company Report #USA030332487 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Health Zyprexa Professional (Olanzapine) PS ORAL 2.5 MG/DAY 5 YR Date:11/28/03ISR Number: 4259284-5Report Type:Periodic Company Report #USA030332590 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa Apathy (Olanzapine) PS ORAL 10 MG/AT Asthenia BEDTIME Dyspepsia Atenolol C Fatigue Altace (Ramipril0 C Feeling Abnormal Zoloft C Sensation Of Heaviness Date:11/28/03ISR Number: 4259286-9Report Type:Periodic Company Report #USA030332645 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa Crying (Olanzapine) PS 2.5 MG/AT Difficulty In Walking BEDTIME Disturbance In Attention Actonel (Risedronate Nervousness Sodium) C Nightmare Restlessness Tremor Weight Increased Date:11/28/03ISR Number: 4259288-2Report Type:Periodic Company Report #USA030332659 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activities Of Daily Consumer Strattera Living Impaired (Atomoxetine Aggression Hydrochloride0 PS 25 MG/DAY Asthenia Zyprexa-Oral Dizziness (Olanzapine) Fatigue (Olanzapine) SS 2.5 MG/DAY Feeling Abnormal Somnolence Date:11/28/03ISR Number: 4259290-0Report Type:Periodic Company Report #USA030332770 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Strattera Middle Insomnia (Atomoxetine Prescribed Overdose Hydrochloride) PS ORAL 120 MG/3 DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS ORAL 60 MG/DAY Zyprexa 24-Jun-2005 12:19 PM Page: 2653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS ORAL Klonopin (Clonazepam) C ORAL Date:11/28/03ISR Number: 4259291-2Report Type:Periodic Company Report #USA030332810 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa Professional Oral (Olanzapine) PS ORAL 15 MG/DAY Date:11/28/03ISR Number: 4259293-6Report Type:Periodic Company Report #USA030432895 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa Aggression Health Oral (Olanzapine) PS 2.5 MG/AT Agitation Professional BEDTIME Arthralgia Paxil (Paroxetine Chest Pain Hydrochloride) C Crying Dyspnoea Emotional Disorder Feeling Hot Feeling Jittery Flushing Headache Hyperhidrosis Hyperphagia Hypersomnia Insomnia Middle Insomnia Nervousness Pain In Extremity Polydipsia Screaming Skin Disorder Skin Striae Somnolence Staring Swelling Torticollis Vomiting Weight Increased Date:11/28/03ISR Number: 4259294-8Report Type:Periodic Company Report #USA030432921 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Necrosis Health Zyprexa-Oral Hepatic Steatosis Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259295-XReport Type:Periodic Company Report #USA030432927 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4259296-1Report Type:Periodic Company Report #USA030432937 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa-Oral Hallucination Professional (Olanzapine) Prescribed Overdose Company (Olanzapine) PS 30 UG/DAY Representative Aripiprazole C Date:11/28/03ISR Number: 4259297-3Report Type:Periodic Company Report #USA030432961 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Decreased Consumer Zyprexa-Oral Snoring (Olanzapine) Weight Increased (Olanzapine) PS 10 MG/DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 30 MG/DAY Date:11/28/03ISR Number: 4259308-5Report Type:Periodic Company Report #USA030432964 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa-Oral Weight Loss Poor Professional (Olanzapine) (Olanzapine) PS Ativan(Lorazepam) C Zoloft(Sertraline Hydrochloride) C Norco C Date:11/28/03ISR Number: 4259311-5Report Type:Periodic Company Report #USA030432998 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4259312-7Report Type:Periodic Company Report #USA030433110 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Antiphospholipid Health Antibodies Positive Professional Company 24-Jun-2005 12:19 PM Page: 2655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/IN THE MORNING Coumadin(Warfarin Sodium) C Seroquel(Quetiapine Fumarate) C Zocor (Simvastatin) C Date:11/28/03ISR Number: 4259314-0Report Type:Periodic Company Report #USA030433157 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Health Zyprexa-Oral Lethargy Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY 1 MON Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Lithium C Date:11/28/03ISR Number: 4259315-2Report Type:Periodic Company Report #USA030433170 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Health Zyprexa-Oral Confusional State Professional (Olanzapine) Dizziness Company (Olanzapine) PS 20 MG Medication Error Representative Somnolence Date:11/28/03ISR Number: 4259317-6Report Type:Periodic Company Report #USA030433188 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa-Oral Fatigue (Olanzapine) Prescribed Overdose (Olanzapine) PS 30 MG/DAY 4 YR Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4259320-6Report Type:Periodic Company Report #USA030433222 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Nausea (Olanzapine) Somnolence (Olanzapine) PS 2.5 MG/AT BEDTIME Strattera (Atomoxetine Hydrochloride) SS 40 MG/DAY 2 WK 24-Jun-2005 12:19 PM Page: 2656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Concerta (Methylphenidate Hydrochloride) C Date:11/28/03ISR Number: 4259349-8Report Type:Periodic Company Report #USA030433257 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Zyprexa Oral Professional (Olanzapine) PS ORAL Company Representative Date:11/28/03ISR Number: 4259350-4Report Type:Periodic Company Report #USA030433392 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Burning Sensation Zyprexa Hyperhidrosis Oral (Olanzapine) PS ORAL 2.5 MG/DAY 5 MON Levodopa-Carbidopa C Zoloft (Sertraline Hydrochloride) C Galantamine C Date:11/28/03ISR Number: 4259351-6Report Type:Periodic Company Report #USA030433481 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa-Oral Bradykinesia Professional (Olanzapine) Dyskinesia (Olanzapine) PS 20 MG/DAY Tardive Dyskinesia Klonopin (Clonazepam) C Date:11/28/03ISR Number: 4259352-8Report Type:Periodic Company Report #USA030433487 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Health Zyprexa Professional Oral (Olanzapine) PS 10 MG/DAY Date:11/28/03ISR Number: 4259353-XReport Type:Periodic Company Report #USA030433672 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Consumer Forteo Depression (Teriparatide) PS 20 UG/DAY Disturbance In Attention Zyprexa Injection Site Oral (Olanzapine) SS ORAL 5 MG/DAY Haemorrhage Cozaar Weight Decreased (Losartan Potassium) C Lithium C Pepcid (Famotidine) C Primidone C Synthroid (Levothyroxine 24-Jun-2005 12:19 PM Page: 2657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Zocor (Simvastatin) C Date:11/28/03ISR Number: 4259354-1Report Type:Periodic Company Report #USA030433680 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa Childhood Psychosis Oral (Olanzapine) PS ORAL 5 MG/DAY Dissociation Adderall Xr C Homicidal Ideation Lexapro Suicidal Ideation (Escitalopram) C Date:11/28/03ISR Number: 4259355-3Report Type:Periodic Company Report #USA030433835 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Social Health Zyprexa Behaviour Professional Oral (Olanzapine) PS 2.5 MG/2 DAY Injury Carbamazepine C Rash Effexor-Xr (Venlafaxine Hydrochloride) C Ambien (Zolpiedem Tartrate) C Seroquel (Quetiapine Fumarate) C Date:11/28/03ISR Number: 4259356-5Report Type:Periodic Company Report #USA030433901 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Zyprexa Paranoia Professional Oral (Olanzapine) PS 2.5 MG/DAY Thinking Abnormal Fosamax (Aledronate Treatment Noncompliance Sodium) C Vitamins C Ativan (Lorazepam) C Propoxyphene C Date:11/28/03ISR Number: 4259357-7Report Type:Periodic Company Report #USA030434034 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa Agitation Professional Oral Eye Disorder (Olanzapine) PS ORAL 5 MG Feeling Cold Remeron Peripheral Coldness (Mirtazapine) C Tremor Celexa (Citalopram Hdyrobromide) C 24-Jun-2005 12:19 PM Page: 2658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4259358-9Report Type:Periodic Company Report #US_030494156 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperphagia Consumer Zyprexa-Oral Middle Insomnia (Olanzapine) PS Lithium C Date:11/28/03ISR Number: 4259359-0Report Type:Periodic Company Report #US_030494241 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa-Oral Professional (Olanzapine) PS 5 MG/DAY Company Representative Date:11/28/03ISR Number: 4259360-7Report Type:Periodic Company Report #US_030594464 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa-Oral Vein Disorder (Olanzapine) PS 2.5 MG Date:11/28/03ISR Number: 4259361-9Report Type:Periodic Company Report #US_030594474 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Premature Baby Health Zyprexa-Oral Professional (Olanzapine) PS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Date:11/28/03ISR Number: 4259362-0Report Type:Periodic Company Report #US_030594501 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Consumer Zyprexa-Oral Hypersomnia (Olanzapine) PS 10 MG Date:11/28/03ISR Number: 4259363-2Report Type:Periodic Company Report #US_030594562 Age:8 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa-Oral Professional (Olanzapine) PS 2.5 MG Date:11/28/03ISR Number: 4259364-4Report Type:Periodic Company Report #US_030594709 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Other Zyprexa-Oral Thinking Abnormal (Olanzapine) PS Gabitril (Tiagabine 24-Jun-2005 12:19 PM Page: 2659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/28/03ISR Number: 4259365-6Report Type:Periodic Company Report #US_030594872 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:11/28/03ISR Number: 4259366-8Report Type:Periodic Company Report #US_030695009 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa-Oral Insulin-Dependent Professional (Olanzapine) PS 15 MG/DAY Weight Increased Lamictal (Lamotrigine) C Effexor (Venlafaxine Hydrochloride) C Date:11/28/03ISR Number: 4259367-XReport Type:Periodic Company Report #US_030695098 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:11/28/03ISR Number: 4263155-8Report Type:Periodic Company Report #USA030434047 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hunger Consumer Zyprexa-Oral Increased Appetite (Olanzapine) (Olanzapine) PS 2.5 MG/AT BEDTIME Date:11/28/03ISR Number: 4263157-1Report Type:Periodic Company Report #US030434114 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Prolixen (Fluphenazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263159-5Report Type:Periodic Company Report #USA030434146 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa-Oral Dry Mouth (Olanzapine) Ejaculation Disorder (Olanzapine) PS 160 MG/DAY Lethargy Strattera Peripheral Coldness (Atomoxetine Prescribed Overdose Hydrochloride) SS 80 MG/DAY Somnolence Zyprexa-Oral (Olanzapine) (Olanzapine) SS Ativan (Lorazepam) C Celexa (Citalopram Hydrobromide) C Wellbutrin (Bupropion Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4263161-3Report Type:Periodic Company Report #USA030434200 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa-Oral Hunger (Olanzapine) Hypersomnia (Olanzapine) PS 35 MG/DAY Increased Appetite Remeron Oedema (Mirtazapine) C Prescribed Overdose Risperdal Weight Increased (Risperidone) C Date:11/28/03ISR Number: 4263162-5Report Type:Periodic Company Report #USA030434221 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa-Oral Fatigue (Olanzapine) Feeling Abnormal (Olanzapine) PS 10 MG/DAY 3 MON Feeling Drunk Effexor (Venlafaxine Increased Appetite Hydrochloride) C Insomnia Prilosec Lethargy (Omeprazole) C Weight Increased Date:11/28/03ISR Number: 4263164-9Report Type:Periodic Company Report #USA030434224 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glycosylated Haemoglobin Health Zyprexa-Oral Increased Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263166-2Report Type:Periodic Company Report #USA030434237 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Consumer Zyprexa-Oral Middle Insomnia (Olanzapine) Stress (Olanzapine) PS Lithium C Date:11/28/03ISR Number: 4263167-4Report Type:Periodic Company Report #USA030434249 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Risperdal (Risperidone) C Clonazepam C Diphenhydramine C Date:11/28/03ISR Number: 4263170-4Report Type:Periodic Company Report #USA030434288 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Diastolic Health Strattera Increased Professional (Atomoxetine Blood Pressure Systolic Hydrochloride) PS 40 MG/IN THE Increased MORNING Heart Rate Increased Zyprexa-Oral (Olanzapine) (Olanzapine) SS Adderall C Clonidine C Date:11/28/03ISR Number: 4263172-8Report Type:Periodic Company Report #USA030434292 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4263177-7Report Type:Periodic Company Report #USA030844581 Age:12 YR Gender:Female I/FU:I Outcome PT Anger Crying Decreased Appetite Disturbance In Attention Fatigue Feeling Abnormal Hallucination Insomnia Memory Impairment Psychomotor Hyperactivity 24-Jun-2005 12:19 PM Page: 2662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 3 WK Advair C Flovent (Fluticasone Propionate) C Date:11/28/03ISR Number: 4263178-9Report Type:Periodic Company Report #USA030844595 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Burning Sensation Health Zyprexa Erythema Professional Zydis-Dispersible Company (Olanzapine) PS 5 MG Representative Date:11/28/03ISR Number: 4263179-0Report Type:Periodic Company Report #USA030844689 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Consumer Zyprexa-Oral (Olanzapine) PS ORAL 2.5 MG Effexor (Venlafaxine Hydrochloride) C Xanax C Date:11/28/03ISR Number: 4263180-7Report Type:Periodic Company Report #USA030844849 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa Glossodynia Health (Olanzapine) PS ORAL 2.5 MG Swollen Tongue Professional Tongue Disorder Date:11/28/03ISR Number: 4263181-9Report Type:Periodic Company Report #USA030844857 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa Weight Increased (Olanzapine) PS ORAL 20 MG/AT BEDTIME Inderal (Propranolol Hydrochloride) C Fluoxetine Hydrochloride C 24-Jun-2005 12:19 PM Page: 2663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263182-0Report Type:Periodic Company Report #USA030844858 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paralysis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS ORAL Date:11/28/03ISR Number: 4263183-2Report Type:Periodic Company Report #USA030844992 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oropharyngeal Swelling Health Zyprexa Professional (Olanzapine) PS ORAL 10 MG Company Representative Date:11/28/03ISR Number: 4263184-4Report Type:Periodic Company Report #USA030845000 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Zyprexa-Oral Joint Swelling (Olanzapine) Laryngitis (Olanzapine) PS ORAL 5 MG/AT Lichen Planus BEDTIME Oedema Peripheral Valium (Diazepam) C Weight Increased Chlor-Trimeton (Chlorphenamine Maleate) C Aspirin C Date:11/28/03ISR Number: 4263185-6Report Type:Periodic Company Report #USA030845061 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Chloride Decreased Health Zyprexa Blood Creatinine Professional (Olanzapine) PS ORAL 5 MG/DAY Decreased Tylenol Hyponatraemia (Paracetamol) C Red Blood Cell Count Bisacodyl C Decreased Calcium And Vitamin D C Levodopa-Carbidopa C Celexa (Citalopram Hydrobromide) C Docusate Sodium C Doxazosin C Milk Of Magnesia C Multivitamins Nos (Multivitamins Nos) C Pramitexole C Testosterone C 24-Jun-2005 12:19 PM Page: 2664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263186-8Report Type:Periodic Company Report #USA030845072 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Zyprexa Convulsion Professional (Olanzapine) PS ORAL 30 MG/DAY Laboratory Test Abnormal Dilantin (Phenytoin Prescribed Overdose Sodium) C Vistaril (Hydroxyzine Embonate) C Date:11/28/03ISR Number: 4263187-XReport Type:Periodic Company Report #USA030845624 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa-Oral Cerebrovascular Accident (Olanzapine) Fall (Olanzapine) PS Limb Operation Aricept (Donepezil Parkinson'S Disease Hydrochloride) C Rib Fracture Remeron Somnolence (Miortazapine) C Date:11/28/03ISR Number: 4263188-1Report Type:Periodic Company Report #USA030845702 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Communication Disorder Consumer Zyprexa-Oral Difficulty In Walking (Olanzapine) Intentional Misuse (Olanzapine) PS 15 MG Date:11/28/03ISR Number: 4263189-3Report Type:Periodic Company Report #USA030845772 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Weight Increased Professional (Olanzapine) PS Company Representative Date:11/28/03ISR Number: 4263191-1Report Type:Periodic Company Report #USA030945837 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Consumer Zyprexa-Oral Fatigue (Olanzapine) PS 30 MG/1 AT Feeling Abnormal BEDTIME Flat Affect Prescribed Overdose Somnolence Tardive Dyskinesia Tremor 24-Jun-2005 12:19 PM Page: 2665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263193-5Report Type:Periodic Company Report #USA030945875 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Partial Seizures Health Zyprexa-Oral Professional (Olanzapine) PS 5 MG/DAY Company Depo-Medrol Representative (Methylperdnisolone Acetate) C Triamterene/Hydrochl oride C Depo-Medrol (Methylprednisolone Acetate) C Triamterene/Hydrochl orothiazide C Trazodone C Protonix (Pantoprazole) C Date:11/28/03ISR Number: 4263194-7Report Type:Periodic Company Report #USA030945882 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa-Oral Dysarthria Professional (Olanzapine) PS 20 MG/DAY Dysphagia Company Zoloft (Sertraline Insomnia Representative Hydrochloride) C Depakote (Valproate Semisodium) C Naprosyn (Naproxen) C Benzatropine C Date:11/28/03ISR Number: 4263195-9Report Type:Periodic Company Report #USA030945947 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Zyprexa Prescribed Overdose Professional Zydis-Dispersible (Olanzapine) PS 20 MG/2 DAY Valproic Acid C Lithium C Clonapin (Clonazepam) C Ativan (Lorazepam) C Date:11/28/03ISR Number: 4263197-2Report Type:Periodic Company Report #USA030945966 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Consumer Zyprexa-Oral Depression (Olanzapine) PS 5 MG/AT Dizziness BEDTIME Fatigue Zoloft (Sertraline Feeling Abnormal Hydrochloride) C Food Craving Mood Altered Suicidal Ideation Weight Increased 24-Jun-2005 12:19 PM Page: 2666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263199-6Report Type:Periodic Company Report #USA030946034 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa-Oral Impaired Gastric Emptying Professional (Olanzapine) PS 20 MG/DAY Company Haldol (Haloperidol) C Representative Clonazepam C Valium Diazepam C Date:11/28/03ISR Number: 4263200-XReport Type:Periodic Company Report #USA030946126 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Consumer Zyprexa-Oral Prescribed Overdose Company (Olanzapine) PS 40 MG/DAY Representative Date:11/28/03ISR Number: 4263201-1Report Type:Periodic Company Report #USA030946159 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa-Oral Hallucination (Olanzapine) Headache (Olanzapine) PS 2.5 MG/DAY Muscle Spasms Skin Burning Sensation Somnolence Tremor Vision Blurred Visual Acuity Reduced Vitreous Floaters Date:11/28/03ISR Number: 4263202-3Report Type:Periodic Company Report #USA030946235 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa Blood Triglycerides Professional Oral (Olanzapine) PS ORAL 2 DAY Increased Company Representative Date:11/28/03ISR Number: 4263203-5Report Type:Periodic Company Report #USA030946251 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa-Oral Illogical Thinking (Olanzapine) Mood Swings (Olanzapine) PS 7.5 MG/DAY Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263204-7Report Type:Periodic Company Report #USA030946277 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa-Oral Dry Skin (Olanzapine) Dysphonia (Olanzapine) PS 5 MG/1 AT Fatigue BEDTIME Increased Appetite Cortisone C Tremor Desyrel (Trazodone Weight Increased Hydrochloride) C Date:11/28/03ISR Number: 4263208-4Report Type:Periodic Company Report #USA030946310 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa Blood Triglycerides Oral (Olanzapine) PS 15 MG Increased Amaryl (Glimepiride) C Diabetes Mellitus Asa (Acetylsalicylic Glycosylated Haemoglobin Acid) C Increased Norvasc (Amlodipine Besilate) C Toprol Xl (Metoprolol Succinate) C Acupril (Quinapril) C Metformin C Date:11/28/03ISR Number: 4263212-6Report Type:Periodic Company Report #USA030946325 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Consumer Zyprexa Menstrual Disorder Oral (Olanzapine) PS ORAL 2.5 MG/AT Oedema Peripheral BEDTIME Paxil (Paroxetine Hydrochloride) C Lithium C Wellbutrin (Bupropion Hydrochloride) C Xanax (Alprazolam) C Depo Provera (Medroxyprogesterone Acetate) C Date:11/28/03ISR Number: 4263215-1Report Type:Periodic Company Report #USA030946368 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Zyprexa Intentional Misuse Professional Oral (Olanzapine) PS Ketoacidosis Company Suicide Attempt Representative 24-Jun-2005 12:19 PM Page: 2668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263219-9Report Type:Periodic Company Report #USA030946442 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restless Legs Syndrome Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4263221-7Report Type:Periodic Company Report #USA030946518 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Trismus Health Zyprexa-Oral Weight Increased Professional (Olanzapine) (Olanzapine) PS 10MG/2 DAY Benadryl (Diphenhydramine Hydrochloride) C Date:11/28/03ISR Number: 4263223-0Report Type:Periodic Company Report #USA030946550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Abnormal Consumer Zyprexa-Oral Thirst (Olanzapine) (Olanzapine) PS 15 MG/IN THE MORNING Date:11/28/03ISR Number: 4263226-6Report Type:Periodic Company Report #USA030740669 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Zyprexa-Oral (Olanzapine) (Olanzapine) PS 30 MG Date:11/28/03ISR Number: 4263228-XReport Type:Periodic Company Report #USA030740673 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa-Oral Syndrome Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4263230-8Report Type:Periodic Company Report #USA030740690 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Suppressed Lactation Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 2.5 MG/1 DAY 9 WK Paxil Cr C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263231-XReport Type:Periodic Company Report #USA030740701 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY 1 WK Representative Date:11/28/03ISR Number: 4263232-1Report Type:Periodic Company Report #USA030740707 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Health Zyprexa-Oral Oedema Professional (Olanzapine) Company (Olanzapine) PS Representative Risperdal (Risperidone) C Date:11/28/03ISR Number: 4263233-3Report Type:Periodic Company Report #USA030740708 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Oedema Health Zyprexa-Oral Oedema Professional (Olanzapine) Oedema Peripheral (Olanzapine) PS 20 MG/DAY Atenolol C Lipitor (Atorvastatin) C Leucovorin C Date:11/28/03ISR Number: 4263234-5Report Type:Periodic Company Report #USA030740709 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4263235-7Report Type:Periodic Company Report #USA030740716 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Strattera Feeling Abnormal (Atomoxetine Increased Appetite Hydrochloride) PS 40 MG/DAY Insomnia Zyprexa-Oral Skin Striae (Olanzapine) Somnolence (Olanzapine) SS 10 MG/DAY Weight Increased Remeron (Mirtazapine) C Clonazepam C Relafen (Nabumetone) C Celebrex (Celecoxib) C Marijuana C Lexapro (Escitalopram) C 24-Jun-2005 12:19 PM Page: 2670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263236-9Report Type:Periodic Company Report #USA030740808 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Zyprexa- Oral Decreased Appetite (Olanzapine) Disorientation (Olanzapine) PS 5 MG/1 AT Dry Mouth BEDTIME Feeling Abnormal Zoloft (Sertraline Hallucination, Visual Hydrochloride) C Somnolence Date:11/28/03ISR Number: 4263237-0Report Type:Periodic Company Report #USA030740811 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Date:11/28/03ISR Number: 4263238-2Report Type:Periodic Company Report #USA030845147 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mononucleosis Syndrome Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Strattera (Atomoxetine Hydrochloride) C Date:11/28/03ISR Number: 4263240-0Report Type:Periodic Company Report #USA030845167 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 2 DAY Centrum C Vitamin B C Date:11/28/03ISR Number: 4263241-2Report Type:Periodic Company Report #USA030845181 Age: Gender:Female I/FU:I Outcome PT Abdominal Pain Upper Agitation Anxiety Buccoglossal Syndrome Confusional State Dizziness Dry Mouth Headache 24-Jun-2005 12:19 PM Page: 2671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Muscle Rigidity Nausea Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Consumer Zyprexa-Oral Restlessness (Olanzapine) Somnolence (Olanzapine) PS 20 MG/DAY Tremor Urinary Retention Urine Analysis Abnormal Date:11/28/03ISR Number: 4263244-8Report Type:Periodic Company Report #USA030845192 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiovascular Disorder Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4263246-1Report Type:Periodic Company Report #USA030845198 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Drug Interaction (Atomoxetine Dyspepsia Hydrochloride) PS 60 MG/DAY Fatigue Zyprexa-Oral Headache (Olanzapine) Hypersomnia (Olanzapine) SS Mood Swings Nausea Somnolence Date:11/28/03ISR Number: 4263250-3Report Type:Periodic Company Report #USA030845232 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa-Oral Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 4 MON Representative Date:11/28/03ISR Number: 4263252-7Report Type:Periodic Company Report #USA030845307 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Lacrimation Increased (Olanzapine) PS 10 MG/DAY Photosensitivity Reaction Ultracet C Humalog C Lantus (Insulin Glargine) C 24-Jun-2005 12:19 PM Page: 2672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263255-2Report Type:Periodic Company Report #USA030845374 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa-Oral Drug Ineffective (Olanzapine) PS 15 MG/4 DAY Muscle Spasms Vasotec (Enalapril Prescribed Overdose Maleate) C Prilosec (Omeprazole) C Premarin (Estrogens Conjugated) C Zyrtec (Cetirizine Hydrochloride) C Calcium C Vitamin E C Prenatal Vitamins C Naprosyn (Naproxen) C Flexeril (Cyclobenzaprine Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Lomotil C Date:11/28/03ISR Number: 4263263-1Report Type:Periodic Company Report #USA030845432 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Consumer Zyprexa-Oral Sleep Disorder Health (Olanzapine) PS 20 MG/DAY Weight Increased Professional Zoloft (Sertraline Hydrochloride) C Depakote (Valproate Semisodium) C Hydroxyzine C Methocarbamol C Naprosyn (Naproxen) C Date:11/28/03ISR Number: 4263264-3Report Type:Periodic Company Report #USA030845485 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Consumer Zyprexa-Oral Feeling Abnormal (Olanzapine) PS 2.5 MG/DAY Feeling Drunk Effexor (Venlafaxine Mental Impairment Hydrochloride) C Ativan (Lorazepam) C Date:11/28/03ISR Number: 4263275-8Report Type:Periodic Company Report #US_030897314 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Foetal Heart Rate Consumer Zyprexa-Oral Deceleration (Olanzapine) (Olanzapine) PS Albuterol C Lexapro (Escitalopram) C 24-Jun-2005 12:19 PM Page: 2673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263277-1Report Type:Periodic Company Report #US_030997796 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa-Oral Psychotic Disorder (Olanzapine) Restlessness (Olanzapine) PS 15 MG/DAY Zoloft (Sertraline Hydrochloride) C Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Aspirin (E.C.) (Acetylsalicylic Acid) C Mvi (Mvi) C Antivert C Date:11/28/03ISR Number: 4263279-5Report Type:Periodic Company Report #US_980706519 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa (Olanzapine) PS 5 MG/DAY Thrombocytopenia Professional Eskalith (Lithium Company Carbonate) C Representative Zoloft (Sertraline Hydrochloride) C Date:11/28/03ISR Number: 4263281-3Report Type:Periodic Company Report #US_980809227 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa-Oral Delusion Of Grandeur (Olanzapine) Diabetes Mellitus (Olanzapine) PS 20 MG/DAY Headache Humalog-. (Lispro) SS 4 YR Hypertension Lamictal Increased Appetite (Lamotrigine) C Sedation Weight Increased Date:11/28/03ISR Number: 4263284-9Report Type:Periodic Company Report #US_981113794 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chemical Poisoning Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Diarrhoea (Olanzapine) PS 5 MG/DAY Early Morning Awakening Valium (Diazepam) C Epilepsy Headache Hypoaesthesia Nocturia Weight Increased 24-Jun-2005 12:19 PM Page: 2674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263286-2Report Type:Periodic Company Report #US_990115396 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Prozac-Oral Drug Effect Increased (Fluoxetine) Drug Ineffective (Fluoxetine Dyspepsia Hydrochloride) PS 60 MG/1 DAY 8 YR Nervousness Zyprexa-Oral Somnolence (Olanzapine) Visual Disturbance (Olanzapine) SS Stelazine (Trifluoperazine Hydrochloride) C Valium (Diazepam) C Date:11/28/03ISR Number: 4263287-4Report Type:Periodic Company Report #US97024858A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Consumer Humalog-Human Decreased Activity Insulin (Rdna):25% Disturbance In Attention Lispro, 75% Npl (Li PS 80 U/DAY Hypoglycaemia Zyprexa-Oral Impaired Self-Care (Olanzapine) Memory Impairment (Olanzapine) SS Osteoporosis Humulin-Human Nph Overweight Insulin (Rdna) Peripheral Coldness (Human Insulin (Rd SS 50 U DAY Weight Increased Humulin-Human Regular Insulin (Rdna) (Human Insulin SS 34 U DAY Date:11/28/03ISR Number: 4263289-8Report Type:Periodic Company Report #USA020616791 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Spontaneous Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 7.5 MG/AT BEDTIME Serzone (Nefazodone Hydrochloride) C Date:11/28/03ISR Number: 4263290-4Report Type:Periodic Company Report #USA020617026 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Zyprexa-Oral Asthenia (Olanzapine) Dental Caries (Olanzapine) PS 20 MG/DAY Dry Mouth Haldol (Haloperidol) C Faecal Incontinence Ativan (Lorazepam) C Feeling Abnormal Atarax (Hydroxyzine Oral Soft Tissue Disorder Hydrochloride) C Skin Discolouration Lactulose C Urinary Incontinence Weight Increased 24-Jun-2005 12:19 PM Page: 2675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4263292-8Report Type:Periodic Company Report #USA020820334 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Consumer Zyprexa-Oral Increased (Olanzapine) Blood Urea Increased (Olanzapine) PS 15 MG/AT Calcium Metabolism BEDTIME Disorder Restoril (Temazepam) C Dry Mouth Calcium C Insomnia Methylsulfonylmethan Sleep Walking e C Somnolence Date:11/28/03ISR Number: 4264638-7Report Type:Periodic Company Report #USA030639150 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY 2 MON Representative Date:11/28/03ISR Number: 4264640-5Report Type:Periodic Company Report #USA030639032 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Consumer Zyprexa-Oral Initial or Prolonged Prescribed Overdose (Olanzapine) Thinking Abnormal (Olanzapine) PS 30 MG Depakote(Valproate Semisodium) C Cogentin(Benzatropin e Mesilate) C Date:11/28/03ISR Number: 4264723-XReport Type:Periodic Company Report #USA030638693 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY Representative Date:11/28/03ISR Number: 4264727-7Report Type:Periodic Company Report #USA030538179 Age:45 YR Gender:Female I/FU:I Outcome PT Hospitalization - Axillary Pain Initial or Prolonged Blindness Other Breast Engorgement Breast Tenderness Confusional State Dehydration Dizziness Dry Throat Dysstasia Feeling Abnormal 24-Jun-2005 12:19 PM Page: 2676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Groin Pain Hangover Report Source Product Role Manufacturer Route Dose Duration Hypertrophy Breast Consumer Zyprexa-Oral Increased Appetite (Olanzapine) Injury (Olanzapine) PS 20 MG/DAY Local Swelling Loss Of Consciousness Musculoskeletal Stiffness Nightmare Somnolence Swelling Vaginal Discharge Vomiting Date:11/28/03ISR Number: 4264730-7Report Type:Periodic Company Report #USA030537847 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Other Lobar Pneumonia Company (Olanzapine) PS 5 MG/DAY Pancreatitis Acute Representative Kcl (Potassium Chloride) C Date:11/28/03ISR Number: 4264733-2Report Type:Periodic Company Report #USA030537855 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Zyprexa-Oral Initial or Prolonged Hyperglycaemia Professional (Olanzapine) Thirst (Olanzapine) PS 1 MON Aldactone (Spironolactone) C Epivir (Lamivudine) C Prevacid (Lansoprazole) C Date:11/28/03ISR Number: 4264734-4Report Type:Periodic Company Report #USA030537827 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/2 DAY Representative Date:11/28/03ISR Number: 4264736-8Report Type:Periodic Company Report #USA030537583 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Zyprexa-Oral Initial or Prolonged White Blood Cell Count Professional (Olanzapine) Decreased (Olanzapine) PS 5 MG 24-Jun-2005 12:19 PM Page: 2677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4264752-6Report Type:Periodic Company Report #USA030537107 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Consumer Strattera Initial or Prolonged Hallucination, Auditory Health (Atomoxetine Tremor Professional Hydrochloride) PS 25 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS Allegra (Fexofenadine Hydrochloride) C Eskalith (Lithium Carbonate) C Insulin C Microgestin Fe C Pancrease Microtabs C Paxil (Paroxetine Hydrochloride) C Date:11/28/03ISR Number: 4264753-8Report Type:Periodic Company Report #USA030536748 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa-Oral Initial or Prolonged Confusional State (Olanzapine) Other Dementia (Olanzapine) PS 7.5 MG/DAY Trazodone C Aciphex (Rabeprazole Sodium) C Date:11/28/03ISR Number: 4265095-7Report Type:Periodic Company Report #USA030434744 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Facial Palsy Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Effexor - Slow Release (Venlafaxine Hydrochloride) C Ativan (Lorazepam) C Date:11/28/03ISR Number: 4265097-0Report Type:Periodic Company Report #USA030434555 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS 10 MG / 2 DAY Lithium C Niaspan (Nicotinic Acid ) C 24-Jun-2005 12:19 PM Page: 2678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4265099-4Report Type:Periodic Company Report #USA030434539 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Ativan (Lorazepam) C Date:11/28/03ISR Number: 4265417-7Report Type:Periodic Company Report #USA030536639 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine) Weight Increased (Olanzapine) PS 10 MG/DAY Metformin C Unknown Diabetes Medication C Date:11/28/03ISR Number: 4265422-0Report Type:Periodic Company Report #USA030536586 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Zyprexa-Oral Initial or Prolonged Heart Rate Decreased Professional (Olanzapine) Hypotension (Olanzapine) PS 20 MG Date:11/28/03ISR Number: 4265426-8Report Type:Periodic Company Report #USA030536435 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Liver Function Test Professional (Olanzapine) Abnormal Company (Olanzapine) PS 7.5 MG/DAY Pyrexia Representative Clonazepam C Lorazepam C Lithium C Ascorbic Acid C Asa(Acetylsalicylic Acid) C Finasterine C Lansoprazole C Oxycodone C Metoprolol C Simvastatin C Terazosin C Zinc Sulfate C Quetiapine C Date:11/28/03ISR Number: 4265432-3Report Type:Periodic Company Report #USA030536263 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4265436-0Report Type:Periodic Company Report #USA030536160 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4265439-6Report Type:Periodic Company Report #USA030536101 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY 9 DAY Representative Date:11/28/03ISR Number: 4265444-XReport Type:Periodic Company Report #USA030536073 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4265448-7Report Type:Periodic Company Report #USA030536043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4265456-6Report Type:Periodic Company Report #USA030535851 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4265702-9Report Type:Periodic Company Report #USA030435822 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Suicide Attempt Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Tegretol (Carbamazepine) C Celexa (Citalopram) C Valerian Root C Klonopin 24-Jun-2005 12:19 PM Page: 2680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Date:11/28/03ISR Number: 4265703-0Report Type:Periodic Company Report #USA030435741 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4265704-2Report Type:Periodic Company Report #USA030435743 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa-Oral Initial or Prolonged Cardiac Arrest Professional (Olanzapine) Other Syncope Company (Olanzapine) PS 5 MG Representative Aspirin C Digoxin C Hyzaar C Date:11/28/03ISR Number: 4265705-4Report Type:Periodic Company Report #USA030435638 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY Representative Depakote (Valproate Semisodium) C Date:11/28/03ISR Number: 4265706-6Report Type:Periodic Company Report #USA030435640 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4265707-8Report Type:Periodic Company Report #USA030435472 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Aricept (Donepezil Hydrochloridr) C Elavil (Amitriptyline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4265708-XReport Type:Periodic Company Report #USA030435237 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus (Olanzapine) Hallucination, Auditory (Olanzapine) PS 30 MG/DAY Prescribed Overdose Zyprexa Weight Decreased Zydis-Dispersible Weight Increased (Olanzapine) (Olanzapine) SS 30 MG/DAY 3 WK Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Paxil (Paroxetine Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Haldol (Haloperidol) C Date:11/28/03ISR Number: 4265709-1Report Type:Periodic Company Report #USA030435237 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus (Olanzapine) Hallucination, Auditory (Olanzapine) PS 30 MG/DAY Prescribed Overdose Zyprexa Weight Decreased Zydis-Dispersible Weight Increased (Olanzapine) (Olanzapine) SS 30 MG/DAY 3 WK Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Paxil (Paroxetine Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Haldol (Haloperidol) C Date:11/28/03ISR Number: 4265710-8Report Type:Periodic Company Report #USA030435026 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa-Oral Initial or Prolonged Breast Mass (Olanzapine) Diarrhoea (Olanzapine) PS 5 MG/DAY Faeces Discoloured Paxil (Paroxetine Gynaecomastia Hydrochloride) C Hallucination, Auditory Headache Schizophrenia Tremor 24-Jun-2005 12:19 PM Page: 2682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4265712-1Report Type:Periodic Company Report #USA030434973 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 10 MG/DAY Date:11/28/03ISR Number: 4266321-0Report Type:Periodic Company Report #USA030741096 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Intentional Misuse Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:11/28/03ISR Number: 4266323-4Report Type:Periodic Company Report #USA030741067 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Date:11/28/03ISR Number: 4266324-6Report Type:Periodic Company Report #USA030740995 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Consumer Zyprexa-Oral Initial or Prolonged Blood Glucose Decreased (Olanzapine) Other Convulsion (Olanzapine) PS 30 MG/AT Dental Caries BEDTIME Diabetes Mellitus Prozac-Oral Hallucination (Fluoxetine) Hallucination, Auditory (Fluoxetine Injury Hydrochloride) SS 20 MG/2 DAY Libido Increased Tegretol Paranoia (Carbamazepine) C Prescribed Overdose Psychomotor Hyperactivity Road Traffic Accident Skin Atrophy Skin Striae Suicidal Ideation Weight Decreased Weight Increased Date:11/28/03ISR Number: 4266326-XReport Type:Periodic Company Report #USA030740759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 15 MG Representative Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 2683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266327-1Report Type:Periodic Company Report #USA030640335 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG/DAY Representative Date:11/28/03ISR Number: 4266329-5Report Type:Periodic Company Report #USA030640075 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Joint Swelling Health Zyprexa-Oral Initial or Prolonged Pyrexia Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Date:11/28/03ISR Number: 4266330-1Report Type:Periodic Company Report #USA030640090 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Zyprexa-Oral Initial or Prolonged Dyspnoea (Olanzapine) Weight Increased (Olanzapine) PS 10 MG/AT BEDTIME Prozac (Fluoxetine Hydrochloride) C Xanax (Alprazolam) C Tenoretic C Verapamil C Aspirin C Date:11/28/03ISR Number: 4266331-3Report Type:Periodic Company Report #USA030639959 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Professional (Olanzapine) Syndrome Company (Olanzapine) PS Representative Phenergan C Haldol C Date:11/28/03ISR Number: 4266332-5Report Type:Periodic Company Report #USA030639976 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Aricept (Donepezil Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266334-9Report Type:Periodic Company Report #USA030639191 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa-Oral Initial or Prolonged Lethargy Professional (Olanzapine) Overdose (Olanzapine) PS Somnolence Methadone C Date:11/28/03ISR Number: 4266380-5Report Type:Periodic Company Report #USA030844908 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Prozac-Oral Initial or Prolonged Respiratory Depression Professional (Fluoxetine) Somnolence (Fluoxetine Hydrochloride) PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS Date:11/28/03ISR Number: 4266381-7Report Type:Periodic Company Report #USA030844217 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Health Zyprexa-Oral Initial or Prolonged Schizophrenia Professional (Olanzapine) Tremor Company (Olanzapine) PS 30 MG Representative Date:11/28/03ISR Number: 4266382-9Report Type:Periodic Company Report #USA030843896 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS Date:11/28/03ISR Number: 4266383-0Report Type:Periodic Company Report #USA030843708 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Consumer Zyprexa-Oral Hospitalization - Death (Olanzapine) Initial or Prolonged Feeling Abnormal (Olanzapine) PS 5 MG/DAY Muscle Rigidity Paralysis Parkinson'S Disease Renal Failure Salivary Hypersecretion Somnolence 24-Jun-2005 12:19 PM Page: 2685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266384-2Report Type:Periodic Company Report #USA030742888 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Inadequate Control Company (Olanzapine) PS 30 MG Hypoglycaemia Representative Prescribed Overdose Date:11/28/03ISR Number: 4266386-6Report Type:Periodic Company Report #USA030742740 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Consumer Zyprexa-Oral Initial or Prolonged Dizziness (Olanzapine) Headache (Olanzapine) PS 10 MG/DAY Increased Appetite Wellbutrin(Bupropion Migraine Hydrochloride) C Nausea Zoloft (Sertraline Vomiting Hydrochloride) C Weight Increased Ortho Tri-Cyclen C Dhe-45(Dihydroergota mine Mesilate) C Date:11/28/03ISR Number: 4266388-XReport Type:Periodic Company Report #USA030742508 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa-Oral Initial or Prolonged Disorientation Professional (Olanzapine) Other Dry Skin Company (Olanzapine) PS 20 MG/DAY 1 YR Hyperpyrexia Representative Lithium C Neuroleptic Malignant Topamax(Topiramate) C Syndrome Lorazepam C White Blood Cell Count Artane(Trihexyphenid Increased yl Hydrochloride) C Doxepin C Periactin (Cyproheptadine Hydrochloride) C Seroquel(Quetiapine Fumarate) C Date:11/28/03ISR Number: 4266389-1Report Type:Periodic Company Report #USA030742301 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Prozac-Oral Initial or Prolonged Anxiety (Fluoxetine) Convulsion (Fluoxetine Obsessive-Compulsive Hydrochloride) PS 60 MG/1 IN Disorder THE MORNING Zyprexa-Oral (Olanzapine) (Olanzapine) SS 17.5 MG/DAY Klonopin (Clonazepam) C Topamax(Topiramate) C 24-Jun-2005 12:19 PM Page: 2686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Contraceptive Pill(Oral Contraceptive Nos) C Date:11/28/03ISR Number: 4266391-XReport Type:Periodic Company Report #USA030741601 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4266392-1Report Type:Periodic Company Report #USA030741332 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) Other Delirium (Olanzapine) PS 450 MG Loss Of Consciousness Overdose Pyrexia Tachycardia Date:11/28/03ISR Number: 4266393-3Report Type:Periodic Company Report #US_010974120 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Consumer Zyprexa (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Diarrhoea Depakote(Valproate Liver Function Test Semisodium) C Abnormal Zoloft(Sertraline Muscle Rigidity Hydrochloride) C Pneumonia Stress Vomiting Date:11/28/03ISR Number: 4266395-7Report Type:Periodic Company Report #US_011074974 Age:19 YR Gender:Male I/FU:I Outcome PT Hospitalization - Amnesia Initial or Prolonged Anxiety Other Autism Communication Disorder Constipation Convulsion Deformity Derealisation Diarrhoea Drug Dependence Dystonia Electrolyte Depletion Emotional Disorder Hallucination Hypermetabolism 24-Jun-2005 12:19 PM Page: 2687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Illusion Insomnia Limb Deformity Report Source Product Role Manufacturer Route Dose Duration Mental Disorder Consumer Zyprexa-Oral Mental Impairment Health (Olanzapine) Mental Retardation Professional (Olanzapine) PS 10 MG/DAY Severity Unspecified Nausea Schizophrenia Somnolence Starvation Tardive Dyskinesia Tremor Weight Increased Date:11/28/03ISR Number: 4266397-0Report Type:Periodic Company Report #USA030948028 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Consumer Zyprexa-Oral Initial or Prolonged Feeling Abnormal (Olanzapine) Incontinence (Olanzapine) PS Pyrexia Buspar(Buspirone Hydrochloride) C Date:11/28/03ISR Number: 4266398-2Report Type:Periodic Company Report #USA030948147 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Diabetic Coma Professional (Olanzapine) Prescribed Overdose Company (Olanzapine) PS 45 MG/AT Weight Increased Representative BEDTIME 6 YR Date:11/28/03ISR Number: 4266403-3Report Type:Periodic Company Report #USA030947631 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa-Oral Other Completed Suicide Health (Olanzapine) Embolism Professional (Olanzapine) PS 20 MG/AT Intentional Misuse Company BEDTIME Pulmonary Embolism Representative Pulmonary Haemorrhage Date:11/28/03ISR Number: 4266404-5Report Type:Periodic Company Report #USA030947719 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Strattera(Atomoxetin Initial or Prolonged Drug Effect Decreased e Hydrochloride) PS 80 MG/2 DAY Prescribed Overdose Zyprexa-Oral Psychomotor Hyperactivity (Olanzapine) Weight Increased (Olanzapine) SS 5 MG/DAY 24-Jun-2005 12:19 PM Page: 2688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266405-7Report Type:Periodic Company Report #USA030946929 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caffeine Consumption Consumer Zyprexa-Oral Initial or Prolonged Hallucination, Auditory (Olanzapine) Insomnia (Olanzapine) PS 35 MG/DAY Nervousness Micronase Prescribed Overdose (Glibenclamide) C Restlessness Date:11/28/03ISR Number: 4266406-9Report Type:Periodic Company Report #USA030946315 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Zyprexa-Oral Initial or Prolonged Fracture (Olanzapine) Other Loss Of Consciousness (Olanzapine) PS Skull Fracture Dilantin (Phenytoin Sodium) C Depakote (Valproate Semisodium) C Phenobarb (Phenobarbital Sodium) C Risperdal (Risperidone) C Date:11/28/03ISR Number: 4266407-0Report Type:Periodic Company Report #USA030946222 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Movement Disorder Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Date:11/28/03ISR Number: 4266408-2Report Type:Periodic Company Report #USA030845647 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Gynaecomastia Company (Olanzapine) PS Hyperglycaemia Representative Date:11/28/03ISR Number: 4266410-0Report Type:Periodic Company Report #USA030330759 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa Initial or Prolonged Decreased Appetite Professional (Olanzapine) PS 10 MG/DAY Other Influenza Like Illness Company Carbamazepine C Orthostatic Hypotension Representative Lisinopril C Weight Decreased 24-Jun-2005 12:19 PM Page: 2689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266412-4Report Type:Periodic Company Report #USA020819494 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Prozac Initial or Prolonged Depression Professional (Fluoxetine Mental Disorder Hydrochloride) PS Premature Labour Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG/DAY Date:11/28/03ISR Number: 4266413-6Report Type:Periodic Company Report #US_030997819 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa Initial or Prolonged Hallucination Professional (Olanzapine) PS ORAL 5 MG/AT Hallucination, Auditory Other BEDTIME Initial Insomnia Metadate Er Nightmare (Methylphenidate) C Psychotic Disorder Paxil Cr C Self Mutilation Concerta (Methylphenidate Hydrochloride) C Date:11/28/03ISR Number: 4266414-8Report Type:Periodic Company Report #US_030997695 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Consumer Zyprexa Initial or Prolonged Communication Disorder (Olanzapine) PS ORAL 20 MG/DAY Disturbance In Attention Zoloft (Sertraline Palpitations Hydrochloride) C Seroquel (Quetiapine Fumarate) C Clonazepam C Date:11/28/03ISR Number: 4266415-XReport Type:Periodic Company Report #US_030695605 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphonia Health Zyprexa Initial or Prolonged Schizophrenia Professional (Olanzapine) PS OPHTHALMIC 15 MG/AT BEDTIME Date:11/28/03ISR Number: 4266416-1Report Type:Periodic Company Report #US_030695164 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Consumer Zyprexa Initial or Prolonged Erectile Dysfunction (Olanzapine) PS ORAL 5 MG/AT BEDTIME Vitamins Nos C Wellbutrin (Bupropion Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266417-3Report Type:Periodic Company Report #US_030695107 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Health Strattera Hospitalization - Blood Ph Decreased Professional (Atomoxetine Initial or Prolonged Confusional State Company Hydrochloride) PS ORAL 80 MG/DAY Dehydration Representative Zyprexa-Oral Dry Mouth (Olanzapine) Nausea (Olanzapine) SS ORAL 30 MG/DAY Polydipsia Clonazepam C Polyuria Prescribed Overdose Vomiting Date:11/28/03ISR Number: 4266418-5Report Type:Periodic Company Report #US_030594645 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Zyprexa Initial or Prolonged Confusional State Professional (Olanzapine) PS 450 MG/DAY Depression Other Xanax (Alprazolam) C Fatigue Quetiapine Fumarate C Hallucination Enalapril Maleate C Intentional Misuse Acetaminophen C Sedation Multivitamins C Suicide Attempt Depakote (Valproate Semisodium) C Tums (Calcium Carbonate) C Date:11/28/03ISR Number: 4266419-7Report Type:Periodic Company Report #USA030434525 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Xanax (Alprazolam) C Date:11/28/03ISR Number: 4266420-3Report Type:Periodic Company Report #USA030434217 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4266421-5Report Type:Periodic Company Report #USA030434168 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Zyprexa-Oral Initial or Prolonged Convulsion Professional (Olanzapine) Prescribed Overdose Company (Olanzapine) PS 30 MG/DAY Representative 24-Jun-2005 12:19 PM Page: 2691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266422-7Report Type:Periodic Company Report #USA030434001 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Strattera Hospitalization - Aphagia Professional (Atomoxetine Initial or Prolonged Drug Interaction Hydrochloride) PS 25 MG/DAY Lethargy Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Paxil Cr C Ritalin La (Methylphenidate Hydrochloride) C Date:11/28/03ISR Number: 4266423-9Report Type:Periodic Company Report #USA030433529 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4266424-0Report Type:Periodic Company Report #USA030433160 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS 30 MG/DAY Seroquel (Quetiapine Fumarate) C Trileptal (Oxcarbazepine) C Date:11/28/03ISR Number: 4266425-2Report Type:Periodic Company Report #USA030433103 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative Date:11/28/03ISR Number: 4266426-4Report Type:Periodic Company Report #USA030332835 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Zyprexa-Oral Initial or Prolonged Abnormal Professional (Olanzapine) Company (Olanzapine) PS 8 WK Representative 24-Jun-2005 12:19 PM Page: 2692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4266427-6Report Type:Periodic Company Report #USA030332300 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Zyprexa-Oral Initial or Prolonged Overdose Professional (Olanzapine) (Olanzapine) PS 50 MG/DAY Date:11/28/03ISR Number: 4266428-8Report Type:Periodic Company Report #USA030332076 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa-Oral Initial or Prolonged Prescribed Overdose Professional (Olanzapine) Other Company (Olanzapine) PS 25 MG/AT Representative BEDTIME Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Haloperidol C Depo Provera (Medroxyprogesterone Acetate) C Ranitidine C Ibuprofen C Date:12/01/03ISR Number: 4243461-3Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0042494A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Quilonum Retard PS Glaxosmithkline ORAL 675MG per day 19 DAY Initial or Prolonged Parkinsonism Zyprexa SS ORAL 15MG per day Zoloft SS ORAL 50MG per day Convulex C ORAL 800MG per day Risperdal C UNKNOWN 6 WK Date:12/02/03ISR Number: 4243902-1Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0316024A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Lithium Carbonate PS Glaxosmithkline UNKNOWN 100MG Per day Initial or Prolonged Olanzapine SS UNKNOWN 5MG Per day Lipitor SS ORAL 20MG Per day 157 WK Date:12/02/03ISR Number: 4245692-5Report Type:Expedited (15-DaCompany Report #SUSI-2003-00478 Age:51 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Carbatrol(Carbamazep Health ine) Capsule Xr PS ORAL ORAL Professional Olanzapine(Olanzapin e) SS ORAL ORAL Trazodone(Trazodone) SS 24-Jun-2005 12:19 PM Page: 2693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/03ISR Number: 4246318-7Report Type:Direct Company Report #CTU 207362 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS 5 MG QHS Initial or Prolonged Weight Increased HOME MED Required Intervention to Prevent Permanent Impairment/Damage Date:12/03/03ISR Number: 4246388-6Report Type:Direct Company Report #CTU 207402 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Zyprexa (Eli Lilly) PS Eli Lilly 5 MG 1 DAILY Date:12/03/03ISR Number: 4246606-4Report Type:Expedited (15-DaCompany Report #2003119683 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zoloft (Sertraline) PS ORAL 100 MG, ORAL Leukopenia Health Olanzapine Neutropenia Professional (Olanzapine) SS ORAL 10 MG, ORAL Lorazepam (Lorazepam) SS ORAL 0.5 MG, ORAL Date:12/03/03ISR Number: 4246612-XReport Type:Expedited (15-DaCompany Report #DE_030912119 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Zyprexa-Oral Health (Olanzapine) PS 10 MG/DAY Professional Cipramil (Citalopram Company Hydrobromide) C Representative Reminyl (Galantamine Other Hydrobromide) C Date:12/03/03ISR Number: 4246613-1Report Type:Expedited (15-DaCompany Report #EWC031136981 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Olanzapine-Oral Hospitalization - Complete Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Professional Midazolam C Other Date:12/03/03ISR Number: 4246615-5Report Type:Expedited (15-DaCompany Report #US_031198976 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Oral Initial or Prolonged Generalised Oedema Health (Olanzapine) PS 2.5 MG/DAY 1 DAY Other Rash Professional Renal Failure Other 24-Jun-2005 12:19 PM Page: 2694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/03ISR Number: 4246619-2Report Type:Expedited (15-DaCompany Report #GBS031113993 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Activated Partial Foreign Olanzapine-Oral Hospitalization - Thromboplastin Time Health (Olanzapine) PS 60 MG/DAY Initial or Prolonged Prolonged Professional Citalopram C Other Blood Urea Decreased Other Coagulopathy Electrocardiogram Abnormal Hyperkalaemia International Normalised Ratio Increased Prescribed Overdose Date:12/03/03ISR Number: 4246730-6Report Type:Expedited (15-DaCompany Report #USA031050800 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa Abnormal Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Depakote (Valproate Semisodium) C Date:12/03/03ISR Number: 4246770-7Report Type:Expedited (15-DaCompany Report #USA031050802 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa Abnormal Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Depakote (Valproate Semisodium) C Date:12/03/03ISR Number: 4246772-0Report Type:Expedited (15-DaCompany Report #USA031050803 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa Abnormal Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Depakote (Valproate Semisodium) C Date:12/03/03ISR Number: 4246776-8Report Type:Expedited (15-DaCompany Report #USA031049346 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytoclastic Health Zyprexa-Oral Vasculitis Professional (Olanzapine) (Olanzapine) PS 7.5 MG./DAY Coumadin (Warfarin Sodium) C 24-Jun-2005 12:19 PM Page: 2695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/03ISR Number: 4246777-XReport Type:Expedited (15-DaCompany Report #USA031050804 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa Abnormal Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Depakote (Valproate Semisodium) C Date:12/03/03ISR Number: 4246780-XReport Type:Expedited (15-DaCompany Report #USA031050501 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa Abnormal Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS Depakote (Valproate Sodium) C Date:12/03/03ISR Number: 4246785-9Report Type:Expedited (15-DaCompany Report #US_020988011 Age:63 YR Gender:Male I/FU:F Outcome PT Death Anoxia Hospitalization - Body Temperature Initial or Prolonged Decreased Other Cardiac Arrest Cardiac Failure Congestive Choreoathetosis Coma Confusional State Convulsion Coordination Abnormal Delirium Dysarthria Extensor Plantar Response Gait Disturbance Grimacing Hyperreflexia Hypotonia Hypoxia Intentional Misuse Lethargy Leukocytosis Metabolic Acidosis Methicillin-Resistant Staphylococcal Aureus Test Positive Myoclonus Nystagmus Pneumonia Productive Cough Restlessness Rhabdomyolysis Salivary Hypersecretion Somnolence 24-Jun-2005 12:19 PM Page: 2696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Status Epilepticus Ventricular Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 750 MG Lithium C Terazosin C Rabeprazole C Methocarbamol C Thiamine C Ibuprofen C Date:12/03/03ISR Number: 4246791-4Report Type:Expedited (15-DaCompany Report #US_030393671 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa - Oral Initial or Prolonged Alanine Aminotransferase (Olanzapine) Increased (Olanzapine) PS Angina Pectoris Glucophage Aspartate (Metformin Aminotransferase Hydrochloride) C Increased Glucotrol Blood Calcium Decreased (Glipizide) C Blood Urea Decreased Zantac (Ranitidine Diabetes Mellitus Hydrochloride) C Diarrhoea Haemorrhagic Zoloft (Sertraline Flank Pain Hydrochloride) C Haematuria Xenical (Orlistat) C Hepatic Steatosis Multivitamin C Hepatobiliary Scan Nausea Nephrolithiasis Pain Renal Colic Scan Abnormal Treatment Noncompliance Urinary Retention Vaginal Mycosis Vomiting Weight Increased Date:12/03/03ISR Number: 4246797-5Report Type:Expedited (15-DaCompany Report #US_031198945 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:12/03/03ISR Number: 4246886-5Report Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Other PT Report Source Product Role Manufacturer Route Dose Duration Abulia Foreign Zyprexa-Oral Crackles Lung Health (Olanzapine) Decreased Appetite Professional (Olanzapine) PS 10 MG/DAY Diabetic Coma Company Serenace Diabetic Ketoacidosis Representative (Haloperidol) C Dialysis Other Diet Refusal Hyperventilation Hypotension Metabolic Acidosis Obesity Pyrexia Renal Failure Acute Respiratory Failure Tachycardia Tachypnoea Vomiting White Blood Cell Count Increased Date:12/03/03ISR Number: 4246985-8Report Type:Expedited (15-DaCompany Report #FR_030902879 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Syndrome Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Xanax (Alprazolam) C Theralene (Alimenazine Tartrate) C Imovane (Zopiclone0 C Date:12/03/03ISR Number: 4246988-3Report Type:Expedited (15-DaCompany Report #JP_030801654 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa-Oral Initial or Prolonged Consciousness Study (Olanzapine) Hypochloraemia Health (Olanzapine) PS 10 MG/DAY Hyponatraemia Professional Lullan (Perospirone Other Hydrochloride) C Depas (Etizolam) C Setous (Zotepine) C Benzalin (Nitrazepam) C Isomytal (Amobarbital) C Picoben Sodium Picosulfate) C Brovain (Bromisoval) C 24-Jun-2005 12:19 PM Page: 2698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/03ISR Number: 4246991-3Report Type:Expedited (15-DaCompany Report #EWC030936368 Age:2 MON Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa-Oral Maternal Drugs Affecting Health (Olanzapine) Foetus Professional (Olanzapine) PS 25 WK Premature Baby Other Renal Disorder Twin Pregnancy Date:12/03/03ISR Number: 4247062-2Report Type:Direct Company Report #CTU 207427 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Olanzapine 10 Mg PS ORAL 10 MG HS ORAL Abnormal Date:12/03/03ISR Number: 4247175-5Report Type:Expedited (15-DaCompany Report #GBS031113984 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lichen Sclerosus Foreign Olanzapine-Oral Health (Olanzapine) PS 50 MG/DAY Professional Other Date:12/03/03ISR Number: 4247177-9Report Type:Expedited (15-DaCompany Report #EWC031137046 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Foreign Zyprexa-Oral Hospitalization - Insomnia Health (Olanzapine) Initial or Prolonged Localised Infection Professional (Olanzapine) PS 30 MG/DAY Mania Other Cisordinol-Acutard Sudden Cardiac Death (Zuclopenthixol Upper Respiratory Tract Acetate) C Infection Cipramil (Citalopram Ventricular Fibrillation Hydrobromide) C Propavan (Propiomazine Maleate) C Stesolid (Diazepam) C Nozinan (Levomepromazine) C Theralen (Alimemazine Tartrate) C Heminevrin (Clomethiazole Edisilate) C Clonazepam C 24-Jun-2005 12:19 PM Page: 2699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/03ISR Number: 4247180-9Report Type:Expedited (15-DaCompany Report #EWC031137016 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Foreign Zyprexa-Oral Calculus Urinary Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Rowatinex C Date:12/03/03ISR Number: 4247181-0Report Type:Direct Company Report #CTU 207353 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Zyprexa 5 Mg PS ORAL 5 MG QHS ORAL Initial or Prolonged Somnolence Cyproheptadine C Speech Disorder Bactrim C Lexapro C Propoxyphene C Date:12/03/03ISR Number: 4247182-2Report Type:Expedited (15-DaCompany Report #EWC031137009 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/IN THE Company EVENING Representative Haldol (Haloperidol) C Other Cisordinol (Clopenthixol Hydrochloride) C Lithium C Date:12/03/03ISR Number: 4247184-6Report Type:Expedited (15-DaCompany Report #AU_020304807 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Fibrosis Foreign Olanzapine-Oral Hospitalization - Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Professional Prednisolone C Other Date:12/04/03ISR Number: 4247303-1Report Type:Direct Company Report #CTU 207492 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa 10 Mg Lilly PS Lilly 1QD Zyrtec 10 Mg Pfizer SS Pfizer Date:12/04/03ISR Number: 4247322-5Report Type:Direct Company Report #CTU 207482 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Lesion Zyprexa PS Eli Lilly 20 MG- 30 MG Vision Blurred Lithium C Oxcarbazepine C Abiliify C 24-Jun-2005 12:19 PM Page: 2700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamictal C Inderal C Date:12/04/03ISR Number: 4247355-9Report Type:Direct Company Report #CTU 207497 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Zyprexa PS ORAL 15 MG PO QHS Initial or Prolonged Extrapyramidal Disorder Zoloft C Remeron C Lico3 C Synthroid C Ecasa C Plavix C Vit E C Coreg C Ativan C Reminyl C Date:12/04/03ISR Number: 4247357-2Report Type:Direct Company Report #CTU 207498 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Zyprexa 5 Mg PS ORAL 20 MG PO QHS Initial or Prolonged Syndrome Mvi C Cardizem Cd C Vit E C Colace C Oscal 500+ D C Colchicine C Date:12/05/03ISR Number: 4245882-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12444063 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Abilify PS Otsuka Other Drug Toxicity Pharmaceutical Head Injury Company, Ltd. ORAL Zyprexa SS QHS Risperdal C Klonopin C ORAL Cogentin C ORAL Remeron C ORAL Hydrochlorothiazide C K-Dur C Date:12/08/03ISR Number: 4249242-9Report Type:Expedited (15-DaCompany Report #6006242 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Health Euthyrox Initial or Prolonged Dermatitis Allergic Professional (Levothyroxine Other Sodium) PS 100 MCG Zyprexa (Olanzapine) SS ORAL 20 MG ORAL Ciatyl (Clopenthixol Hydrochloride) SS 75 MG 11 DAY 24-Jun-2005 12:19 PM Page: 2701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/03ISR Number: 4248897-2Report Type:Direct Company Report #CTU 207708 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Olanzapine (Zyprexa) Initial or Prolonged 5.0 Mg PS ORAL 5MG BY MOUTH DAILY 2 WK Calms Foret C Date:12/09/03ISR Number: 4248901-1Report Type:Direct Company Report #CTU 207764 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Zyprexa 20 Mg Lilly PS Lilly Wellbutrin C Klonopin C Depakote C Date:12/09/03ISR Number: 4249537-9Report Type:Expedited (15-DaCompany Report #EWC031237177 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Olanzapine-Oral Initial or Prolonged Circulatory Collapse Health (Olanzapine) PS 12.5 MG/DAY Electrocardiogram Qt Professional Lorazepam C Prolonged Other Date:12/09/03ISR Number: 4249538-0Report Type:Expedited (15-DaCompany Report #EWC031137136 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Foreign Olanzapine-Oral Oedema Health (Olanzapine) PS Professional Other Date:12/09/03ISR Number: 4249539-2Report Type:Expedited (15-DaCompany Report #EWC031137104 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Foreign Zyprexa-Oral Initial or Prolonged Complications Of Maternal Health (Olanzapine) Exposure To Therapeutic Professional (Olanzapine) PS 5 MG/DAY Drugs Other Oxazepam C Maternal Drugs Affecting Foetus Date:12/09/03ISR Number: 4249540-9Report Type:Expedited (15-DaCompany Report #DE_031112435 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa-Oral Neutropenia Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Zoloft (Sertraline Hydrochloride) C Tavor (Lorazepam) C 24-Jun-2005 12:19 PM Page: 2702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/03ISR Number: 4249541-0Report Type:Expedited (15-DaCompany Report #DE_031112423 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Prescribed Overdose Health (Olanzapine) Weight Increased Professional (Olanzapine) PS 40 MG/DAY Other Date:12/09/03ISR Number: 4249542-2Report Type:Expedited (15-DaCompany Report #DE_031112409 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Foreign Zyprexa-Oral Initial or Prolonged Thrombosis Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Date:12/09/03ISR Number: 4249543-4Report Type:Expedited (15-DaCompany Report #DE_031112405 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Zyprexa-Oral Initial or Prolonged Bundle Branch Block Right Health (Olanzapine) Other Electrocardiogram T Wave Professional (Olanzapine) PS 30 MG/DAY Inversion Other Seroquel(Quetiapine General Physical Health Fumarate) C Deterioration Tavor(Lorazepam) C Myocardial Infarction Beloc Zok(Metoprolol Pyrexia Succinate) C Staphylococcal Sepsis Ciatyl-Z Subileus Acuphase(Zuclopenthi Urinary Retention xol Acetate) C Urosepsis Date:12/09/03ISR Number: 4249549-5Report Type:Expedited (15-DaCompany Report #GBS031114097 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Phenobarbitone C Other Phenytoin C Date:12/09/03ISR Number: 4249550-1Report Type:Expedited (15-DaCompany Report #JP_031002084 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Zyprexa-Oral Initial or Prolonged Convulsion Health (Olanzapine) Other Hyperpyrexia Professional (Olanzapine) PS 20 MG/DAY Pneumonia Aspiration Company Magnesium Oxide C Psychomotor Hyperactivity Representative Propericiazine Pyrexia Other (Periciazine) C Suicide Attempt Carbamazepine C Vomiting Vegetamin A C Chlorpromazine C Promethazine 24-Jun-2005 12:19 PM Page: 2703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Phenobarbital C Levomepromazine C Biperiden Hydrochloride C Flunitrazepam C Sennoside A C Etizolam C Date:12/09/03ISR Number: 4249551-3Report Type:Expedited (15-DaCompany Report #GBS031114087 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar I Disorder Foreign Olanzapine-Oral Sleep Disorder Health (Olanzapine) PS 5 MG/DAY Suicide Attempt Professional Lipitor Other (Atorvastatin) C Lithium Carbonate C Date:12/09/03ISR Number: 4249552-5Report Type:Expedited (15-DaCompany Report #EWC031237179 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Infarction Foreign Olanzapine-Oral Hospitalization - Health (Olanzapine) PS 5 MG/DAY Initial or Prolonged Professional Other Date:12/09/03ISR Number: 4249558-6Report Type:Expedited (15-DaCompany Report #US_031199068 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Seroquel (Quetiapine Fumarate) C Date:12/09/03ISR Number: 4249559-8Report Type:Expedited (15-DaCompany Report #USA031153288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:12/09/03ISR Number: 4249560-4Report Type:Expedited (15-DaCompany Report #USA031153308 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa-Oral Initial or Prolonged Treatment Noncompliance Professional (Olanzapine) Company (Olanzapine) PS Representative Depo Shots Of Another Unspecified Medication C 24-Jun-2005 12:19 PM Page: 2704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/03ISR Number: 4249561-6Report Type:Expedited (15-DaCompany Report #USA031153008 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Health Zyprexa-Oral Exposure To Therapeutic Professional (Olanzapine) Drugs Company (Olanzapine) PS Maternal Drugs Affecting Representative Foetus Stillbirth Date:12/09/03ISR Number: 4249724-XReport Type:Expedited (15-DaCompany Report #US_031198976 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Oral Initial or Prolonged Generalised Oedema Health (Olanzapine) Other Rash Professional (Olanzapine) PS 2.5 MG/DAY 5 DAY Renal Failure Other Date:12/09/03ISR Number: 4249769-XReport Type:Expedited (15-DaCompany Report #03P-163-0235135-00 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Valproic Acid Initial or Prolonged Insulin-Dependent Health (Depakene) (Valproic Ketoacidosis Professional Acid) (Valproic Weight Increased Acid) PS 1500 MG, 1 IN1 D Olanzapine SS ORAL 5 MG, AT BEDTIME, PER ORAL Venlafaxine SS ORAL 75 MG, 1 IN 1 D, PER ORAL Date:12/09/03ISR Number: 4249770-6Report Type:Expedited (15-DaCompany Report #JP_030901731 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Hepatitis Foreign Zyprexa-Oral Initial or Prolonged Food Craving Health (Olanzapine) Other Glucose Urine Present Professional (Olanzapine) PS 20 MG/DAY Hyperglycaemia Company Luvox (Fluvoxamine Hypotension Representative Maleate) C Polydipsia Risperdal Pyrexia (Risperidone) C Solanax (Alprazolam) C Biperiden C Dihydroergotamine Mesilate C Midodrine Hydrochloride C 24-Jun-2005 12:19 PM Page: 2705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/03ISR Number: 4249772-XReport Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Zyprexa-Oral Hospitalization - Pulmonary Oedema Health (Olanzapine) Initial or Prolonged Pyrexia Professional (Olanzapine) PS 10 MG/DAY Renal Failure Acute Company Amoban (Zopiclone) C Respiratory Failure Representative Cercine (Diazepam) C Rhabdomyolysis Cefazolin Sodium C Cravit (Levofloxacin) C Perdipin La (Nicardipine Hydrochloride) C Heparin C Lasix(Furosemide) C Mannitol C Epogin (Epoetin Beta) C Date:12/09/03ISR Number: 4249775-5Report Type:Expedited (15-DaCompany Report #JP_031102150 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Foreign Zyprexa-Oral Cardio-Respiratory Arrest Health (Olanzapine) Loss Of Consciousness Professional (Olanzapine) PS 5 MG/3 DAY Myocardial Infarction Company Wypax (Lorazepam) C Representative Benzalin Other (Nitrazepam) C Hirnamin(Levomeproma zine) C Date:12/09/03ISR Number: 4249776-7Report Type:Expedited (15-DaCompany Report #DE_031012288 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Diet Refusal Health (Olanzapine) Other International Normalised Professional (Olanzapine) PS 2.5 MG/3 DAY Ratio Increased Company Tegretal-Slow Prothrombin Time Representative Release Prolonged Other (Carbamazepine) C Carbium (Carbamazepine) C Thyronajod C Jodthyrox C Pantozol (Pantoprazole Sodium) C Marcumar (Phenprocoumon) C Eugalac (Lactulose) C Novalgin (Metamizole Sodium) C 24-Jun-2005 12:19 PM Page: 2706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/03ISR Number: 4249950-XReport Type:Expedited (15-DaCompany Report #USA030843024 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa-Oral Toxicologic Test Abnormal Professional (Olanzapine) Treatment Noncompliance Company (Olanzapine) PS Representative Oxycontin (Oxycodone Hydrochloride) C Date:12/09/03ISR Number: 4250075-8Report Type:Expedited (15-DaCompany Report #US_030997665 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa-Oral Other Drug Level Increased Health (Olanzapine) Pulmonary Congestion Professional (Olanzapine) PS 7.5 MG Pulmonary Oedema Adderall Xr C Respiratory Arrest Ativan (Lorazepam) C Respiratory Depression Celexa(Citalopram Respiratory Failure Hydrobromide) C Cyclobenzaprine C Date:12/09/03ISR Number: 4250086-2Report Type:Expedited (15-DaCompany Report #GBS031114090 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Olanzapine-Oral Hospitalization - Circulatory Collapse Health (Olanzapine) PS Initial or Prolonged Diabetic Ketoacidosis Professional Quetiapine C Heart Rate Irregular Other Meningeal Disorder Pulmonary Congestion Vomiting Date:12/10/03ISR Number: 4250504-XReport Type:Expedited (15-DaCompany Report #2003UW16014 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS Zyprexa SS Date:12/10/03ISR Number: 4250515-4Report Type:Expedited (15-DaCompany Report #JP_031002099 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Persecutory Delusion Study (Olanzapine) Schizophrenia, Paranoid Health (Olanzapine) PS 10 MG/DAY Type Professional Lexin Other (Carbamazepine) C Hiberna (Promethazine Hydrochloride) C Barnetil (Sultopride) C Rohypnol (Flunitrazepam) C 24-Jun-2005 12:19 PM Page: 2707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bicamol (Biperiden Hydrochloride) C Midodrine Hydrochloride C Amezinium Metilsulfate C Gasmotin (Mosapride Citrate) C Pantosin (Pantethine) C Magnesium Oxide C Sennoside A+B C Halomonth (Haloperidol Decanoate) C Date:12/10/03ISR Number: 4250521-XReport Type:Expedited (15-DaCompany Report #JP_031002058 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diet Refusal Foreign Zyprexa-Oral Other Hypokalaemia Study (Olanzapine) Weight Decreased Health (Olanzapine) PS 10 MG/1 DAY Professional Risperdal Other (Risperidone) C Dogmatyl (Sulpiride) C Pyrethia (Promethazine Hydrochloride) C Risumic (Amezinium Metilsulfate) C Metligine (Midodrine Hydrochloride) C Benzalin (Nitrazepam) C Laxoberon (Sodium Picosulfate) C Date:12/10/03ISR Number: 4250525-7Report Type:Expedited (15-DaCompany Report #CA_030606052 Age:31 YR Gender:Male I/FU:F Outcome PT Death Agitation Hospitalization - Anorexia Initial or Prolonged Aspiration Blood Glucose Increased Dehydration Depressed Level Of Consciousness Diabetic Ketoacidosis Dialysis General Physical Health Deterioration Hepatic Steatosis Hypernatraemia Hypokalaemia Hypotension Lethargy Metabolic Acidosis 24-Jun-2005 12:19 PM Page: 2708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pleural Effusion Pulmonary Oedema Pyrexia Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Foreign Olanzapine-Oral Thirst Study (Olanzapine) PS 10 MG/AT Health BEDTIME Professional Sertraline C Other Risperidone C Citalopram C Date:12/15/03ISR Number: 4251649-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-353546 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Valium PS Roche ORAL 44 DAY Initial or Prolonged Blood Creatine Zyprexa SS ORAL 45 DAY Phosphokinase Increased Imovane SS ORAL 9 DAY Rhabdomyolysis Remeron C ORAL Sleep Disorder Aspirin Cardio C ORAL Enatec C ORAL Date:12/15/03ISR Number: 4253445-7Report Type:Expedited (15-DaCompany Report #2003AP04358 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Oxcarbazepine SS Professional Olanzapine SS Date:12/16/03ISR Number: 4253806-6Report Type:Expedited (15-DaCompany Report #JP_031002041 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Blood Creatine Health (Olanzapine) Other Phosphokinase Increased Professional (Olanzapine) PS 290 MG/1 DAY Blood Potassium Increased Company Body Temperature Representative Increased Other C-Reactive Protein Increased Chromaturia Coma Hepatic Function Abnormal Insomnia Intentional Misuse Overdose Po2 Increased Somnolence Sputum Discoloured Suicide Attempt White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/03ISR Number: 4253808-XReport Type:Expedited (15-DaCompany Report #JP_031002084 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Zyprexa Initial or Prolonged Convulsion Health (Olanzapine) PS ORAL 20 MG/DAY 195 DAY Other Gaze Palsy Professional Magnesium Oxide C Hyperpyrexia Company Propericiazine Pneumonia Aspiration Representative (Periciazine) C Psychomotor Hyperactivity Other Carbamazepine C Vomiting Vegetamin A C Chlorpromazine C Promethazine Hydrochloride C Phenobarbital C Levomepromazine C Flunitrazepam C Sennoside A C Etizolam C Date:12/16/03ISR Number: 4253956-4Report Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Zyprexa-Oral Hospitalization - Dialysis Health (Olanzapine) Initial or Prolonged Pulmonary Oedema Professional (Olanzapine) PS 10 MG/DAY Pyrexia Company Amoban (Zopiclone) C Respiratory Failure Representative Cercine (Diazepam) C Rhabdomyolysis Other Cefazolin Sodium C Cravit (Levofloxacin) C Perdipin La (Nicardipine Hydrochloride) C Heparin C Lasix (Furosemide) C Mannitol C Epogin (Epoetin Beta) C Date:12/16/03ISR Number: 4253975-8Report Type:Expedited (15-DaCompany Report #JP_030801625 Age:60 YR Gender:Male I/FU:F Outcome PT Death Blood Lactate Life-Threatening Dehydrogenase Increased Blood Pressure Decreased C-Reactive Protein Increased Cardiac Failure Cardio-Respiratory Arrest Coma Condition Aggravated Cough Cyanosis Delirium Dyspnoea Dyspnoea Exertional Fall 24-Jun-2005 12:19 PM Page: 2710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Decreased Hypoxia Interstitial Lung Disease Report Source Product Role Manufacturer Route Dose Duration Mydriasis Foreign Zyprexa-Oral Pallor Health (Olanzapine) Pneumothorax Professional (Olanzapine) PS 5 MG/1 AT Respiratory Depression Company BEDTIME White Blood Cell Count Representative Predonine Increased (Prednisolone) C Gatifloxacin C Mucosta (Rebamipide) C Baktar C Silece (Flunitrazepam) C Myslee (Zolpidem Tartrate) C Date:12/16/03ISR Number: 4253983-7Report Type:Expedited (15-DaCompany Report #GBS020310443 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Atherosclerosis Foreign Zyprexa-Oral Cardiac Valve Disease Health (Olanzapine) Congestive Cardiomyopathy Professional (Olanzapine) PS 10 MG/DAY Coronary Artery Other Haloperidol C Atherosclerosis Lustral (Sertraline Dilatation Ventricular Hydrochloride) C Left Ventricular Failure Procyclidine C Pleural Effusion Pulmonary Oedema Ventricular Wall Thickening Date:12/16/03ISR Number: 4254042-XReport Type:Expedited (15-DaCompany Report #USA030843498 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Zyprexa-Oral Hospitalization - Antineutrophil Professional (Olanzapine) Initial or Prolonged Cytoplasmic Antibody Company (Olanzapine) PS 5 MG/DAY 5 MON Other Positive Representative Clonazepam C Blood Culture Positive Drug Screen Positive Fungal Infection Neutropenia Overdose Platelet Count Decreased Renal Failure Respiratory Failure Sepsis Date:12/16/03ISR Number: 4254053-4Report Type:Expedited (15-DaCompany Report #GBS030413027 Age:57 YR Gender:Female I/FU:F Outcome PT Death Cardiac Arrest Completed Suicide Drug Toxicity 24-Jun-2005 12:19 PM Page: 2711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multiple Drug Overdose Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS ORAL Company Zopiclone C Representative Other Date:12/16/03ISR Number: 4254071-6Report Type:Expedited (15-DaCompany Report #JP_030500883 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Olanzapine-Oral Initial or Prolonged Alanine Aminotransferase Study (Olanzapine) PS 10 MG/DAY Increased Health Miradol (Sulpiride) C Aspartate Professional Biperiden C Aminotransferase Other Serenace Increased (Haloperidol) C Blood Bilirubin Increased Parkin (Profenamine) C Blood Lactate Halcion (Triazolam) C Dehydrogenase Increased Pursennide (Senna Difficulty In Walking Leaf) C Flatulence Adalat L Hepatic Cyst (Nifedipine) C Hepatic Function Abnormal Gaster (Famotidine) C Ileus Date:12/16/03ISR Number: 4254077-7Report Type:Expedited (15-DaCompany Report #JP_030801624 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa-Oral Life-Threatening Coombs Direct Test Health (Olanzapine) Other Positive Professional (Olanzapine) PS 5 MG/DAY Depressed Level Of Company Vancomycin-Iv Consciousness Representative (Vancomycin) Disseminated Other (Vancomycin Intravascular Coagulation Hydochlorid SS Heart Rate Decreased Harnal (Tamsulosin Lung Infection Hydrochloride) C Pseudomonal Biofermin C Pneumonia Staphylococcal Sm Powder C Respiratory Failure Clarith (Clarithromycin) C Isodine Gargle (Iodine) C Fungizone (Amphotericin B) C Lendormin (Brotizolam) C Magnesium Oxide C Methyprednisolone Sodium Succinate C Carbentin C Aminofluid C Glunon (Glucose) C Atarax (Hydroxyzine 24-Jun-2005 12:19 PM Page: 2712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Serenace (Haloperidol) C Solita-T3 Injection C Date:12/16/03ISR Number: 4254080-7Report Type:Expedited (15-DaCompany Report #GBS030413039 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Blood Ethanol Increased Consumer (Olanzapine) Completed Suicide Health (Olanzapine) PS 12.5 MG/DAY Drowning Professional Risperidone C Eczema Other Biperiden C Lung Hyperinflation Sedation Speech Disorder Date:12/16/03ISR Number: 4254289-2Report Type:Expedited (15-DaCompany Report #EWC031137046 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Foreign Zyprexa-Oral Hospitalization - Insomnia Health (Olanzapine) Initial or Prolonged Localised Infection Professional (Olanzapine) PS 30 MG/DAY Mania Company Cisordinol-Acutard(Z Sinus Arrest Representative uclopenthixol Sudden Cardiac Death Other Acetate) C Upper Respiratory Tract Cipramil(Citalopram Infection Hydrobromide) C Ventricular Fibrillation Propavan(Propiomazin e Maleate) C Stesolid(Diazepam) C Nozinan(Levomepromaz ine) C Theralen(Alimemazine Tartrate) C Heminevrin(Clomethia zole Edisilate) C Clonazepam C Date:12/16/03ISR Number: 4254292-2Report Type:Expedited (15-DaCompany Report #JP_031001909 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Zyprexa-Oral Initial or Prolonged Upper Gastrointestinal Study (Olanzapine) Haemorrhage Health (Olanzapine) PS 10 MG/DAY Professional Zopiclone C Other Selbex(Teprenone) C Vitamin B Complex C Magnesium Oxide C Gasmotin(Mosapride Citrate) C 24-Jun-2005 12:19 PM Page: 2713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/03ISR Number: 4254373-3Report Type:Expedited (15-DaCompany Report #GBS031013915 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Olanzapine-Oral Fall Health (Olanzapine) PS 20 MG/DAY Nightmare Professional Losartan C Sleep Walking Other Risperidone C Haloperidol C Lorazepam C Zopiclone C Procyclidine C Gavison C Paracetamol C Date:12/17/03ISR Number: 4254416-7Report Type:Expedited (15-DaCompany Report #GBS031214116 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Olanzapine-Oral Life-Threatening Health (Olanzapine) PS 5 MG Professional Trazodone C Other Simvastatin C Bricanyl(Terbutaline Sulfate) C Isosorbide Mononitrate C Paracetamol C Influenza Virus Vaccine C Perindopril C Date:12/17/03ISR Number: 4254550-1Report Type:Expedited (15-DaCompany Report #DSA_23665_2003 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Foreign Tavor PS ORAL 20 TAB ONCE Initial or Prolonged Coma Health PO Intentional Misuse Professional Dominal SS ORAL 160 MG ONCE Multiple Drug Overdose Other PO Zyprexa SS Date:12/17/03ISR Number: 4254663-4Report Type:Expedited (15-DaCompany Report #USA031253765 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:12/17/03ISR Number: 4254666-XReport Type:Expedited (15-DaCompany Report #USA031253841 Age:23 YR Gender:Female I/FU:I Outcome PT Other Agitation General Physical Health Deterioration 24-Jun-2005 12:19 PM Page: 2714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperprolactinaemia Pituitary Tumour Benign Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 45 MG/DAY Seroquel(Quetiapine Fumarate) C Date:12/17/03ISR Number: 4254732-9Report Type:Expedited (15-DaCompany Report #USA031253753 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Zyprexa-Oral Initial or Prolonged Areflexia Professional (Olanzapine) Overdose (Olanzapine) PS 225 MG Respiratory Failure Alcohol C Date:12/17/03ISR Number: 4255005-0Report Type:Expedited (15-DaCompany Report #USA031254005 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa-Oral Drug Toxicity Professional (Olanzapine) Company (Olanzapine) PS 20 MG/DAY 3 MON Representative Date:12/17/03ISR Number: 4266431-8Report Type:Periodic Company Report #2015288 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS ORAL ORAL Amitriptyline (Amitriptyline) SS ORAL ORAL Meprobamate (Meprobamate) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Date:12/17/03ISR Number: 4267702-1Report Type:Periodic Company Report #USA-2003-0007721 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Cocaine SS Acetaminophen (Paracetamol) SS Carisoprodol SS Meprobamate 24-Jun-2005 12:19 PM Page: 2715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Meprobamate) SS Mirtazapine SS Propoxyphen (Dextropropoxyphene) SS Diazepam SS Olanzapine SS Chlorpheniramine SS Phenyltoloxamine SS Caffeine SS Nicotine SS Date:12/17/03ISR Number: 4267850-6Report Type:Periodic Company Report #USA-2003-0007470 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin PS Multiple Drug Overdose Professional Nalbuphine Other (Nalbuphine) SS Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) SS Olanzapine (Olanzapine) SS Amitriptyline (Amitriptyline) SS Nortriptyline (Nortripline) SS Caffeine (Caffeine) SS Date:12/17/03ISR Number: 4267887-7Report Type:Periodic Company Report #USA-2003-0007180 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Olanzapine (Olanzapine) SS Cocaine (Cocaine) SS Fluoxetine (Fluoxetine) SS Methadone (Methadone) SS Nicotine (Nicotine) SS Date:12/17/03ISR Number: 4268408-5Report Type:Periodic Company Report #USA-2003-0009587 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Tablets Professional (Oxycodone Other Hydrochloride) PS 20 MG Promethazine (Promethazine) SS Zyprexa (Olanzapine) SS Valproic Acid 24-Jun-2005 12:19 PM Page: 2716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Valproic Acid) SS Zoloft (Sertraline Hydrochloride) SS Date:12/17/03ISR Number: 4268905-2Report Type:Periodic Company Report #2014957 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Oxytin Tablets 40 Mg Intentional Misuse Professional (Oxycodone Company Hydrochloride) PS ORAL 40 MG, BID, Representative ORAL Other Xanax (Alpraxolam) SS 2 MG Zyprexa(Olanzapine) SS ORAL 40 MG ORAL Cocaine (Cocaine) SS Zoloft SS ORAL ORAL Prilosec C Prilosec C Levoxyl C Date:12/17/03ISR Number: 4268938-6Report Type:Periodic Company Report #USA-2003-0007160 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Oxycodone Professional Hydrochloride PS Other Hydromorphone Hcl SS Venlafaxine SS Olanzapine SS Ethanol SS Nicotine SS Date:12/17/03ISR Number: 4269122-2Report Type:Periodic Company Report #USA-2003-0007037 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin PS Multiple Drug Overdose Professional Hydrocodone Other Bitartrate SS Alcohol SS Caffeine SS Mirtazapine SS Olanzapine SS Valproic Acid SS Venlafaxine SS Propoxyphene SS Date:12/17/03ISR Number: 4270281-6Report Type:Periodic Company Report #USA-2003-0005409 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Consumer Oxycontin Tablets Multiple Drug Overdose Health (Oxycodone Professional Hydrochloride) PS Carisoprodol (Carisoprodol) SS Meprobamate (Meprobamate) SS 24-Jun-2005 12:19 PM Page: 2717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine (Olanzapine) SS Propoxyphene (Dextropropoxyphene) SS Nor-Propoxyhene SS Date:12/17/03ISR Number: 4270368-8Report Type:Periodic Company Report #USA-2003-0008550 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Other (Similar To Nda 20-533) (Oxycodone Hydrochloride) PS MG Dextromethorphan (Dextromethorphan) SS MG Mirtazapine (Mirtazapine) SS MG Olanzapine (Olanzapine) SS MG Paroxetine (Paroxetine) SS MG Promethazine C Date:12/17/03ISR Number: 4270406-2Report Type:Periodic Company Report #USA-2003-0008404 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Tablets Multiple Drug Overdose Professional (Oxycodone Other Hydrochloride) PS ORAL MG, ORAL Hydrocodone Bitartrate (Similar To Ind 59,175) (Hydrocodone Bitartrate) SS Lortab (Paracetamol, Hydrocodone Bitartrate) SS Zyprexa (Olanzapine) SS Celexa (Citalopram Hydrobromide) SS Klonopin (Clonazepam) SS Meprobamate (Meprobamate) SS Depakote (Valproate Sodium) SS Soma (Carisoprodol) C Date:12/17/03ISR Number: 4271286-1Report Type:Periodic Company Report #USA-2002-0003470 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Death Accidental Overdose Consumer Multiple Drug Overdose Health Professional 24-Jun-2005 12:19 PM Page: 2718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Oxycontin Tablets (Oxycodone Hydrochloride) PS Alcohol (Ethanol) SS ORAL ORAL Xanax (Alprazolam) SS Nicotine (Nicotine) SS Ephedrine (Ephedrine) SS Pseudoephedrine (Pseudoephedrine) SS Prochlorperazine (Prochlorperazine) SS Caffeine (Caffeine) SS Zyprexa (Olanzapine) SS Date:12/17/03ISR Number: 4271303-9Report Type:Periodic Company Report #USA-2003-0007793 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Hydrocodone Bitartrate (Similar To Ind 59,175) (Hydrocodone Bitartrate, SS Clonazepam (Clonazepam) SS Olanzapine (Olanzapine) SS Date:12/17/03ISR Number: 4271314-3Report Type:Periodic Company Report #USA-2003-0007768 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Olanzapine (Olanzapine) SS Date:12/17/03ISR Number: 4272075-4Report Type:Periodic Company Report #USA-2003-0010102 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Company (Similar To Nda Representative 20-553) (Oxycodone Other Hydrochloride) PS 24-Jun-2005 12:19 PM Page: 2719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluoxetine (Fluoxetine) SS Olanzapine (Olanzapine) SS Date:12/17/03ISR Number: 4272126-7Report Type:Periodic Company Report #USA-2003-0010412 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Oxycodone Professional Hydrochloride PS Company Olanzapine Representative (Olanzapine) SS Other Date:12/17/03ISR Number: 4273334-1Report Type:Periodic Company Report #USA-2003-0010054 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Company (Similar To Nda Representative 20-553) (Oxycodone Other Hydrochloride) PS Diazepam (Diazepam) SS Alprazolam (Alprazolam) SS Citalopram (Citalopram) SS Olanzapine (Olanzapine) SS Date:12/17/03ISR Number: 4273337-7Report Type:Periodic Company Report #USA-2003-0010057 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Company (Similar To Nda Representative 20-553) (Oxycodone Other Hydrochloride) PS Citalopram (Citalopram) SS Olanzapine (Olanzapine) SS Trazodone (Trazodone) SS Promethazine (Promethazine) SS Date:12/17/03ISR Number: 4273476-0Report Type:Periodic Company Report #USA-2003-0010187 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Death Intentional Misuse Health Multiple Drug Overdose Professional Company 24-Jun-2005 12:19 PM Page: 2720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Oxycodone Hydrochloride (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Hydrocodone Bitartrate (Similar To Ind 59,175) (Hydrocodone Bitartrate, SS Olanzapine (Olanzapine) SS Diazepam (Diazepam) SS Amitriptyline (Amitriptyline) SS Propoxyphene (Dextropropoxyphene) SS Date:12/22/03ISR Number: 4257466-XReport Type:Expedited (15-DaCompany Report #2002GB00947 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Seroquel PS ORAL 200 MG BID PO Intervention to Exposure To Therapeutic Health Seroquel SS ORAL 300 MG DAILY Prevent Permanent Drugs Professional PO Impairment/Damage Gestational Diabetes Other Seroquel SS 350-400MG/DAY Pregnancy SECOND TRIMESTER Seroquel SS 400-450MG/DAY THIRD TRIMESTER Olanzapine SS 10 MG DAILY 10 MON Date:12/22/03ISR Number: 4257768-7Report Type:Expedited (15-DaCompany Report #MK200312-0152-1 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperosmolar Foreign Anafranil 25mg Initial or Prolonged Coma Capsules 100 PS 3 YR Hallucinations, Mixed Olanzapine SS 4 YR Ketonuria Lithium C Metabolic Acidosis Pneumonia Renal Failure Rhabdomyolysis Date:12/23/03ISR Number: 4257918-2Report Type:Expedited (15-DaCompany Report #EWC031237358 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Other Coaxil (Tianeptine) C 24-Jun-2005 12:19 PM Page: 2721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4257923-6Report Type:Expedited (15-DaCompany Report #US_031299251 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Olanzapine-Oral Initial or Prolonged Blood Creatine Literature (Olanzapine) PS 5 MG/DAY Phosphokinase Increased Health Paroxetine C Blood Pressure Professional Fluctuation Other Catatonia Delusion Drug Interaction Dysphagia Early Morning Awakening Feeling Guilty Hyperhidrosis Incontinence Muscle Rigidity Negativism Neuroleptic Malignant Syndrome Psychomotor Retardation Pyrexia Self Esteem Decreased Suicidal Ideation Tachycardia Tachypnoea Weight Decreased Date:12/23/03ISR Number: 4257925-XReport Type:Expedited (15-DaCompany Report #EWC031237283 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Zyprexa-Oral Hospitalization - Cardiovascular Disorder Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG/DAY Company Fluctine (Fluoxetine Representative Hydrochloride) C Other Date:12/23/03ISR Number: 4258131-5Report Type:Expedited (15-DaCompany Report #US_031198664 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zyprexa-Oral Initial or Prolonged Prescribed Overdose Health (Olanzapine)(Olanzap Psychomotor Agitation Professional ine) PS ORAL 60 MG/DAY Company Representative Other Date:12/23/03ISR Number: 4258162-5Report Type:Expedited (15-DaCompany Report #GBS031114090 Age:18 YR Gender:Female I/FU:F Outcome PT Death Abdominal Pain Hospitalization - Blood Glucose Increased Initial or Prolonged Brain Oedema Circulatory Collapse 24-Jun-2005 12:19 PM Page: 2722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Ketoacidosis Heart Rate Irregular Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Vomiting Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Quetiapine C Other Date:12/23/03ISR Number: 4258235-7Report Type:Expedited (15-DaCompany Report #JP_031202320 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Foreign Zyprexa-Oral Other Cardiac Failure Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:12/23/03ISR Number: 4258238-2Report Type:Expedited (15-DaCompany Report #FR_031203287 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Depamide (Valpromide) C Clopixol (Zuclopenthixol Decanoate) C Date:12/23/03ISR Number: 4258241-2Report Type:Expedited (15-DaCompany Report #FR_031203281 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cytolytic Hepatitis Foreign Zyprexa-Oral Hospitalization - Dehydration Health (Olanzapine) Initial or Prolonged Hypernatraemia Professional (Olanzapine) PS 20 MG/DAY Other Hyperpyrexia Other Depakote (Valproate International Normalised Semisodium) C Ratio Increased Ixel (Milnacipran) C Mania Anafranil Pyrexia (Clomipramine Renal Failure Hydrochloride) C Respiratory Distress Tercian Urinary Tract Infection (Cyamemazine) C Mepronizine C Noroxine (Norfloxacin) C Furadantine (Nitrofurantoin) C Loxapac (Loxapine Succinate) C 24-Jun-2005 12:19 PM Page: 2723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4258318-1Report Type:Expedited (15-DaCompany Report #USA020616863 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Zyprexa-Oral Diabetes Mellitus Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS Pancreatic Necrosis Glyburide C Date:12/23/03ISR Number: 4258384-3Report Type:Expedited (15-DaCompany Report #USA031254005 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Zyprexa-Oral Drug Toxicity Professional (Olanzapine) PS 20 MG/DAY 3 MON Company Topiramate C Representative Carbamazepine C Date:12/23/03ISR Number: 4258387-9Report Type:Expedited (15-DaCompany Report #USA030946150 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Health Zyprexa-Oral Initial or Prolonged Extrapyramidal Disorder Professional (Olanzapine) PS 15 MG/DAY Other Parkinsonism Company Lithium C Pyrexia Representative Ativan (Lorazepam) C Cogentin (Benzatropine Mesilate) C Date:12/23/03ISR Number: 4258389-2Report Type:Expedited (15-DaCompany Report #USA030845778 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa-Oral(Olanzap Euphoric Mood Professional ine) PS 60 MG/DAY Grandiosity Prozac-Oral Toxicologic Test Abnormal (Fluoxetine) (Fluoxetine Hydrochloride) SS 30 MG/DAY Xanax (Alprazolam) C Neurontin(Gabapentin ) C Date:12/23/03ISR Number: 4258395-8Report Type:Expedited (15-DaCompany Report #USA031253836 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa-Oral Professional (Olanzapine) PS 20 MG/DAY Gabitril (Tiagabine Hydrochloride) C Galenic /Hydrochorothiazide/ Valsartan/ C 24-Jun-2005 12:19 PM Page: 2724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4258399-5Report Type:Expedited (15-DaCompany Report #USA031254272 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Health Zyprexa-Oral Exposure To Therapeutic Professional (Olanzapine) PS Drugs Company Intra-Uterine Death Representative Maternal Drugs Affecting Foetus Date:12/23/03ISR Number: 4258403-4Report Type:Expedited (15-DaCompany Report #US_031299403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa-Oral Menorrhagia Professional (Olanzapine) PS Date:12/23/03ISR Number: 4258589-1Report Type:Expedited (15-DaCompany Report #GBS031114006 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Chest Pain Consumer (Olanzapine) Cognitive Disorder Other (Olanzapine) PS ORAL Delusion Amisulpride C Depression Sulpiride C Disturbance In Attention Divorced Dysgraphia Homeless Memory Impairment Muscle Spasms Psychotic Disorder Rectal Haemorrhage Schizophrenia, Paranoid Type Sedation Somnolence Tardive Dyskinesia Tic Tongue Oedema Unemployment Date:12/23/03ISR Number: 4258591-XReport Type:Expedited (15-DaCompany Report #EWC031036760 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Olanzapine-Oral Initial or Prolonged Weight Decreased Health (Olanzapine) PS 30 MG/DAY Professional Diazepam C Other Zopiclone C Levomepromazine C Mirtazapine C Acetylsalicylic Acid C Metoprolol C Atenolol C Enalapril C Salvia C 24-Jun-2005 12:19 PM Page: 2725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorprothixen "Neuraxpharm" (Chlorprothixene Hydrochloride) C Flupentixol C Biperiden C Date:12/23/03ISR Number: 4258593-3Report Type:Expedited (15-DaCompany Report #DE_030511354 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Foreign Zyprexa-Oral Hepatosplenomegaly Health (Olanzapine) Polymyositis Professional (Olanzapine) PS 15 MG/DAY Renal Cyst Other Haldol (Haloperidol) C Rhabdomyolysis Date:12/23/03ISR Number: 4258620-3Report Type:Expedited (15-DaCompany Report #USA03105618 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Prozac-Oral Balance Disorder (Fluoxetine) Brain Oedema (Fluoxetine Insomnia Hydrochloride) PS 20 MG/DAY Nervousness Zyprexa-Oral Somnolence (Olanzapine) (Olanzapine) SS 10 MG/DAY Lipitor (Atorvastatin) C Timoptic (Timolol Maleate) C Travatan (Travoprost) C Hydrochlorothiazide C Trazadone (Trazodone) C Clonazepam C Date:12/23/03ISR Number: 4258626-4Report Type:Expedited (15-DaCompany Report #US_030796404 Age:48 YR Gender:Male I/FU:F Outcome PT Death Blood Glucose Increased Hospitalization - Brain Oedema Initial or Prolonged Coma Other Diabetic Ketoacidosis Electrocardiogram Qt Prolonged Gastrointestinal Oedema Hyperglycaemia Hypokalaemia Hypotension Hypovolaemia Intestinal Infarction Liver Disorder Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 2726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multi-Organ Failure Pulse Absent Renal Failure Acute Report Source Product Role Manufacturer Route Dose Duration Respiratory Arrest Health Zyprexa-Oral Respiratory Failure Professional (Olanzapine) PS 15 MG/DAY Rhabdomyolysis Company Gemfibrozil C Representative Amlodipine Besilate C Other Hydrochlorothiazide C Benzatropine Mesilate C Date:12/23/03ISR Number: 4258686-0Report Type:Expedited (15-DaCompany Report #US_031299281 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antipsychotic Drug Level Literature Olanzapine-Oral Initial or Prolonged Below Therapeutic Health (Olanzapine) PS 30 MG/DAY 1 MON Blood Amylase Increased Professional Divalproex Sodium C Blood Disorder Fluphenazine C Catatonia Benztropine C Cellulitis Inh C Depressed Level Of Rifampin C Consciousness Vitamin B6 C Feeling Abnormal Pyrazinamide C Fluid Intake Reduced Hypomagnesaemia Impulsive Behaviour Lipase Increased Neuroleptic Malignant Syndrome Oedema Peripheral Oral Intake Reduced Pitting Oedema Platelet Count Decreased Pneumonia Aspiration Renal Disorder Respiratory Distress Rhabdomyolysis Date:12/24/03ISR Number: 4279790-7Report Type:Periodic Company Report #USA030228323 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Blood Glucose Increased (Olanzapine) Other Diabetes Mellitus (Olanzapine) PS 20 MG/DAY Furuncle Humulin-Human Nph Pancreatitis Insulin (Rdna) Weight Increased (Human Insulin (Rd SS Humalog-.(Lispro) SS Temazepam C Remeron (Mirtazapine) C Trazodone C Celexa (Citalopram Hydrobromide) C Wellbutrin (Bupropion Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/03ISR Number: 4259870-2Report Type:Expedited (15-DaCompany Report #03P-163-0232426-00 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Depakote Er 500mg Initial or Prolonged Rosacea Professional (Depakote Er) Company (Divalproex Sodium) Representative (Divalproex Sodium) PS ORAL 500MG, 2 IN 1 D, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 D, PER ORAL Date:12/26/03ISR Number: 4260995-6Report Type:Expedited (15-DaCompany Report #03P-056-0244669-00 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Depakote 500mg Hospitalization - Distress Syndrome Health (Depakote) Initial or Prolonged Cytolytic Hepatitis Professional (Divalproex Sodium) Dehydration (Divalproex Sodium) PS ORAL 500 MG 1 IN 1 General Physical Health D ORAL Deterioration Olanzapine SS ORAL 20 MG 1 IN 1 Hyperpyrexia D ORAL Mania Loxapine Succinate SS ORAL 50 MG 1 IN 1 Prothrombin Time Ratio D ORAL Decreased Fluindione C Pulmonary Embolism Clomipramine Pyrexia Hydrochloride C Renal Failure Cyamemazine C Mepronizine C Norfloxacin C Nitrofurantoin C Date:12/30/03ISR Number: 4262007-7Report Type:Expedited (15-DaCompany Report #S03-USA-05297-01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Celexa (Citalopram Drug Interaction Hydrobromide) PS ORAL 20 MG QD PO Respiratory Arrest Zyprexa (Olanzapine) SS 7.5 MG QD Respiratory Failure Adderall Xr C Ativan (Lorazepam) C Date:01/02/04ISR Number: 4262090-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0042782A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Quilonum Retard PS Glaxosmithkline ORAL Initial or Prolonged Phosphokinase Increased Trimipramine SS ORAL Bowel Sounds Abnormal Zyprexa SS ORAL Coma Shock Suicide Attempt 24-Jun-2005 12:19 PM Page: 2728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263652-5Report Type:Expedited (15-DaCompany Report #USA031254590 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catheter Related Consumer Humulin-Human Initial or Prolonged Infection Regular Insulin Other Dizziness (Rdna) (Human Urinary Tract Infection Insulin PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS 15 MG/AT BEDTIME Risperdal (Risperidone) SS Lantus (Insulin Glargine) C Date:01/02/04ISR Number: 4263715-4Report Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abulia Foreign Zyprexa-Oral Hospitalization - Anxiety Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Catheter Related Professional Serenace Disability Infection Company (Haloperidol) C Other Decreased Appetite Representative Dehydration Other Diabetic Coma Diabetic Ketoacidosis Haemodialysis Heart Rate Increased Hyperventilation Hypotension Metabolic Acidosis Obesity Oliguria Pneumonia Staphylococcal Psychotic Disorder Pyrexia Renal Failure Acute Respiratory Disorder Rhabdomyolysis Staphylococcal Infection Systemic Inflammatory Response Syndrome Tachypnoea Urinary Tract Infection White Blood Cell Count Increased Date:01/02/04ISR Number: 4263716-6Report Type:Expedited (15-DaCompany Report #US_031198664 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) PS 15 MG/DAY Myocardial Infarction Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 2729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263717-8Report Type:Expedited (15-DaCompany Report #DE_031112335 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apathy Foreign Zyprexa-Oral Completed Suicide Study (Olanzapine) PS 5 MG/DAY Feeling Of Despair Health Zeldox (Ziprasidone Treatment Noncompliance Professional Hydrochloride) C Other Date:01/02/04ISR Number: 4263718-XReport Type:Expedited (15-DaCompany Report #GBS001106994 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Zyprexa (Olanzapine) PS 2.5 MG/IN THE Hospitalization - Fall Health EVNEING Initial or Prolonged Femur Fracture Professional Aspirin C Disability Hypotension Other Lansoprazole C Supraventricular Haloperidol C Extrasystoles Date:01/02/04ISR Number: 4263723-3Report Type:Expedited (15-DaCompany Report #JP_030801622 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Convulsion Health (Olanzapine) PS 2.5 MG/1 AT Productive Cough Professional BEDTIME Company Teicoplanin C Representative Lasix (Furosemide) C Other Total Parenteral Nutrition C Date:01/02/04ISR Number: 4263726-9Report Type:Expedited (15-DaCompany Report #USA020616863 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Consumer Zyprexa-Oral Increased Health (Olanzapine) PS ORAL 2.5 MG/DAY Condition Aggravated Professional Glyburide C Depression Glucophage Diabetes Mellitus (Metformin Glycosylated Haemoglobin Hydrochloride) C Increased Atenolol C Pancreatic Necrosis Date:01/02/04ISR Number: 4263728-2Report Type:Expedited (15-DaCompany Report #USA030947745 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa-Oral White Blood Cell Count Professional (Olanzapine) PS 10 MG/DAY Decreased Company Depakote (Valporate Representative Semisodium) C 24-Jun-2005 12:19 PM Page: 2730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263742-7Report Type:Expedited (15-DaCompany Report #DSA_23619_2003 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Tavor PS Initial or Prolonged Intentional Misuse Health Alcohol SS Mydriasis Professional Citalopram SS ORAL 3600 MG ONCE Nausea Other PO Platelet Count Increased Zyprexa SS ORAL 1800 MG ONCE Prothrombin Time PO Shortened Somnolence Vomiting Date:01/02/04ISR Number: 4263745-2Report Type:Expedited (15-DaCompany Report #EWC031237283 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Zyprexa-Oral Hospitalization - Long Qt Syndrome Health (Olanzapine) Initial or Prolonged Congenital Professional (Olanzapine) PS 5 MG/DAY Company Fluctine (Fluoxetine Representative Hydrochloride) C Other Date:01/02/04ISR Number: 4263746-4Report Type:Expedited (15-DaCompany Report #DE_030611567 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Zyprexa-Oral Initial or Prolonged Respiratory Disorder Health (Olanzapine) Thrombosis Professional (Olanzapine) PS 15 MG/DAY Weight Decreased Other Nizax (Nizatidine) SS Risperdal (Risperidone) C Date:01/02/04ISR Number: 4263758-0Report Type:Expedited (15-DaCompany Report #US_031299506 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:01/02/04ISR Number: 4263759-2Report Type:Expedited (15-DaCompany Report #USA031254707 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263760-9Report Type:Expedited (15-DaCompany Report #USA031254938 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Date:01/02/04ISR Number: 4263771-3Report Type:Expedited (15-DaCompany Report #USA031254590 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catheter Related Consumer Humulin Human Initial or Prolonged Infection Regular Insulin Other Disease Recurrence (Rdna) (Human Dizziness Insulin PS Staphylococcal Infection Zyprexa-Oral Thinking Abnormal (Olanzapine) Urinary Tract Infection (Olanzapine) SS 15 MG/AT BEDTIME Lantus (Insulin Glargine) C Date:01/02/04ISR Number: 4263834-2Report Type:Expedited (15-DaCompany Report #EWC031237409 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa Other Neoplasm Malignant Health (Olanzapine) PS ORAL Refusal Of Treatment By Professional Ativan (Lorazepam) C Patient Other Date:01/02/04ISR Number: 4263835-4Report Type:Expedited (15-DaCompany Report #FR_031203319 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Zyprexa Initial or Prolonged Bradycardia Health (Olanzapine) PS ORAL 5 MG/DAY Creatinine Renal Professional Loxen (Nicardipine Clearance Decreased Other Hydrochloride) C Sinoatrial Block Eupressyl (Urapidil) C Sinus Arrest Depakine Chrono C Ventricular Fibrillation Date:01/02/04ISR Number: 4263836-6Report Type:Expedited (15-DaCompany Report #FR_031203320 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa Health (Olanzapine) PS 7.5 MG/DAY Professional Tercian Other (Cyamemazine) C Neuleptil (Periciazine) C Tegretol (Carbamazepine) C 24-Jun-2005 12:19 PM Page: 2732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263837-8Report Type:Expedited (15-DaCompany Report #FR_031203322 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cytolytic Hepatitis Foreign Zyprexa Velotab PS 15 MG/DAY Initial or Prolonged Hepatitis Cholestatic Health Imovane (Zopiclone) C Professional Akineton Retard Other (Biperiden Hydrochloride) C Sulfarlem (Anethole Trithione) C Rivotril (Clonazepam) C Forlax (Macrogol) C Date:01/02/04ISR Number: 4263838-XReport Type:Expedited (15-DaCompany Report #JP_031102236 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa Initial or Prolonged Increased Health (Olanzapine) PS ORAL 10 MG/DAY Aspartate Professional Evamyl Aminotransferase Company (Lormetazepam) C Increased Representative Alosenn C Blood Chloride Decreased Other Magnesium Oxide C Blood Lactate Nitorol (Isosorbide Dehydrogenase Increased Denitrate) C Blood Osmolarity Bayaspirin Blood Sodium Decreased (Acetylsalicylic Decreased Appetite Acid) C Gamma-Glutamyltransferase Benzalin Increased (Nitrazepam) C Hepatic Function Abnormal Pancytopenia Pyrexia Splenomegaly White Blood Cell Count Decreased Date:01/02/04ISR Number: 4263839-1Report Type:Expedited (15-DaCompany Report #JP_031202380 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Zyprexa Blood Creatine Health (Olanzapine) PS 25 MG/DAY Phosphokinase Increased Professional Blood Pressure Decreased Company Condition Aggravated Representative Dehydration Other Dialysis Hyperglycaemia Neuroleptic Malignant Syndrome Polydipsia Pyrexia Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 2733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263840-8Report Type:Expedited (15-DaCompany Report #DE_031112325 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Foreign Zyprexa Initial or Prolonged Increased Health (Olanzapine) PS 17.5 MG/DAY Laboratory Test Abnormal Professional Quilonum- Slow Pneumonia Company Release (Lithium Pulmonary Embolism Representative Carbonate) C Pulmonary Infarction Other Tegretal - Slow Thrombosis Release (Carbamazepine) C Sortis (Atorvastatin Calcium) C Marcumar (Phenprocoumon) C Date:01/02/04ISR Number: 4264631-4Report Type:Expedited (15-DaCompany Report #03P-056-0245594-00 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Depakine (Depakene) Hospitalization - Atrioventricular Block Health (Sodium Initial or Prolonged Complete Professional Valproate/Valproic Disability Bradycardia Acid) (Sodium Required Hepatic Failure Valproate/Valproic PS ORAL PER ORAL Intervention to Hypertension Urapidil SS ORAL 60 MG, 3 IN 1 Prevent Permanent Hyperthermia Malignant D, PER ORAL Impairment/Damage Renal Failure Nicardipine Sinus Arrest Hydrochloride SS ORAL 50 MG, 2 IN 1 D, PER ORAL Olanzapine SS ORAL 5 MG, 1 IN 1 D, PER ORAL Date:01/04/04ISR Number: 4263218-7Report Type:Direct Company Report #CTU 209246 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Zyprexa 7.5 Mg Tab PS 7.5 MG AT Initial or Prolonged Heart Rate Decreased 11:45AM. 7.5 MG AT 9 PM Ativan C Haldol C Benadryl C Date:01/06/04ISR Number: 4265051-9Report Type:Direct Company Report #CTU 209443 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Malaise Paxil 20 Mg PS QD Pancreatitis Zyprexa SS QD Date:01/06/04ISR Number: 4265346-9Report Type:Direct Company Report #CTU 209422 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Olanzapine PS Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/04ISR Number: 4548330-7Report Type:Direct Company Report #CTU 235841 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Decreased Zyprexa PS 20 MG DAILY Weight Increased Trileptal C Cogentin C Benadryl C Date:01/07/04ISR Number: 4265458-XReport Type:Direct Company Report #USP 56204 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa Zydis PS Lilly TABLET Date:01/07/04ISR Number: 4267150-4Report Type:Expedited (15-DaCompany Report #JP_031202405 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa Chronic Hepatitis Health (Olanzapine) PS ORAL 15 MG/DAY Completed Suicide Professional Hirnamin Injury Asphyxiation Company (Levomepromazine) C Representative Impromen Other (Bromperidol) C Mycosolvan (Ambroxol Hydrochloride) C Theodur (Theophylline) C Pakisonal (Trihexyphenidyl Hydrochloride) C Tasmolin (Biperiden) C Date:01/08/04ISR Number: 4267204-2Report Type:Direct Company Report #CTU 209570 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Zyprexa 7.5 Mg Tab PS 7.5 MG AT Initial or Prolonged Hypotension 11:45 AM AND 7.5 MG AT 9 PM Ativan C Haldol C Benadryl C Date:01/08/04ISR Number: 4268966-0Report Type:Expedited (15-DaCompany Report #USA031254969 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 20MG Representative 24-Jun-2005 12:19 PM Page: 2735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/04ISR Number: 4269146-5Report Type:Expedited (15-DaCompany Report #US_021088952 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Blood Creatine Literature (Olanzapine) Phosphokinase Increased Health (Olanzapine) PS 250 MG 2 MON Blood Immunoglobulin E Professional Haloperidol C Increased Company Cell-Mediated Representative Cytotoxicity Other Depressed Level Of Consciousness Drug Hypersensitivity Eosinophil Count Increased Erythema Intentional Misuse Pruritus Suicide Attempt White Blood Cell Count Increased Date:01/08/04ISR Number: 4269147-7Report Type:Expedited (15-DaCompany Report #JP_031202320 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Other Condition Aggravated Health (Olanzapine) Disease Recurrence Professional (Olanzapine) PS 5 MG/DAY Hyperphagia Company Thyradin S Hypertension Representative (Levothyroxine Irritability Other Sodium) C Logorrhoea Lullan (Perospirone Malaise Hydrochloride) C Pulse Absent Tasmolin (Biperiden) C Respiratory Arrest Atarax-P Treatment Noncompliance (Hydroxyzine Weight Increased Hydrochloride) C Rohipnol (Flunitrazepam) C Benzalin (Nitrazepam) C Pursennid (Senna Leaf) C Date:01/08/04ISR Number: 4269149-0Report Type:Expedited (15-DaCompany Report #GBS020510714 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Infertility Male Foreign Zyprexa-Oral Sperm Count Decreased Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Other 24-Jun-2005 12:19 PM Page: 2736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/04ISR Number: 4268031-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12472429 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Trazodone Hcl PS Apothecon ORAL Life-Threatening Olanzapine SS ORAL Acetaminophen C ORAL Isosorbide Mononitrate C ORAL Simvastatin C ORAL Bricanyl C RESPIRATORY (INHALATION) Influenza Virus Vaccine C Perindopril C ORAL Date:01/09/04ISR Number: 4268705-3Report Type:Expedited (15-DaCompany Report #JP_030100328 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Zyprexa-Oral Anxiety Study (Olanzapine) Dementia Health (Olanzapine) PS 10 MG/DAY Disorientation Professional Orap (Pimozide) C Disturbance In Social Company Artane Behaviour Representative (Trihexyphenidyl Dysphagia Other Hydrochloride) C Eye Rolling Lexotan (Bromazepam) C Insomnia Metligine (Midodrine Intentional Self-Injury Hydrochloride) C Restlessness Cabagin-U Tab. Speech Disorder (Vitamin U) C Date:01/09/04ISR Number: 4269159-3Report Type:Expedited (15-DaCompany Report #DSA_23785_2003 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Tavor PS Initial or Prolonged Intentional Misuse Health Metoprolol SS Mydriasis Professional Remergil SS Other Taxilan SS Zyprexa SS Date:01/12/04ISR Number: 4268747-8Report Type:Direct Company Report #CTU 209664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Zyprexa 10 Mg Lilly PS Lilly ORAL 10 MG BID Initial or Prolonged Diarrhoea ORAL Disability Urinary Incontinence Other Weight Increased Date:01/12/04ISR Number: 4269834-0Report Type:Expedited (15-DaCompany Report #HQWYE028805JAN04 Age:34 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Exposure During Initial or Prolonged Pregnancy 24-Jun-2005 12:19 PM Page: 2737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Withdrawal Syndrome Medication Error Pregnancy Report Source Product Role Manufacturer Route Dose Duration Suicide Attempt Consumer Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL 75 MG 1X PER 1 DAY, ORAL Klonopin (Clonazepam, ) SS UNKNOWN; 1 MG 3X PER 1 DAY Lithium (Lithium, ) SS OVERDOSE AMOUNT 30-40 LITHIUM TABLETS Zyprexa (Olanzapine,) SS UNKNOWN; 15 MG 1X PER 1 DAY Date:01/13/04ISR Number: 4270790-XReport Type:Expedited (15-DaCompany Report #HQWYE121506JAN04 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Burning Sensation Consumer Effexor Xr Drug Withdrawal Syndrome (Venlafaxine Pain Hydrochloride, Pruritus Capsule, Extended Suicidal Ideation Release) PS ORAL SEE IMAGE Weight Increased Zyprexa (Olanzapine, ) SS ORAL SEE IMAGE Date:01/13/04ISR Number: 4272033-XReport Type:Expedited (15-DaCompany Report #GBS031214204 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Olanzapine-Oral Complications Of Maternal Health (Olanzapine) PS 2.5 MG Exposure To Therapeutic Professional Folic Acid C Drugs Other Maternal Drugs Affecting Foetus Date:01/14/04ISR Number: 4270582-1Report Type:Direct Company Report #USP 56245 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS TAB Zyrtec SS TAB Date:01/14/04ISR Number: 4270640-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00465 Age:67 YR Gender:Male I/FU:I Outcome PT Other Blood Pressure Decreased Circulatory Collapse 24-Jun-2005 12:19 PM Page: 2738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Report Source Product Role Manufacturer Route Dose Duration Health Carbamazepine PS Novartis Sector: Professional Pharma ORAL 200 mg, BID Olanzapine SS ORAL 10 mg, QD Paracetamol C ORAL UNK, PRN Date:01/14/04ISR Number: 4271380-5Report Type:Direct Company Report #CTU 210046 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:01/14/04ISR Number: 4273681-3Report Type:Expedited (15-DaCompany Report #JP_031202417 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Zyprexa-Oral Hospitalization - Delusion Study (Olanzapine) Initial or Prolonged Depressed Level Of Health (Olanzapine) PS 5 MG/DAY Consciousness Professional Vegetamin A C Dizziness Other Tinelac (Sennoside Hallucination, Auditory A+B) C Hypercapnia Uniphyl Insomnia (Theophylline) C Pneumonia Alosenn C Schizophrenia Ruefrien C Somnolence Rohypnol Suicide Attempt (Flunitrazepam) C Tasmolin (Biperiden) C Depas (Etizolam) C Brotizolam C Emilace (Nemonapride) C Zotepine C Date:01/14/04ISR Number: 4273692-8Report Type:Expedited (15-DaCompany Report #US_030796240 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Foreign Olanzapine-Oral Initial or Prolonged Blood Culture Positive Health (Olanzapine) PS 10 MG/DAY Bone Marrow Depression Professional Levomepromazine C Gastric Disorder Other Trifluoperazine C Metrorrhagia Pancytopenia 24-Jun-2005 12:19 PM Page: 2739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/04ISR Number: 4272650-7Report Type:Direct Company Report #CTU 210185 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disorientation Zyprexa PS 2.5 MG 1 QD 2 YR Intervention to Extrapyramidal Disorder Effexor Xr C Prevent Permanent Salivary Hypersecretion Impairment/Damage Sleep Talking Staring Date:01/15/04ISR Number: 4273845-9Report Type:Expedited (15-DaCompany Report #USA031049600 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Mass Health Zyprexa-Oral Initial or Prolonged Pancreatitis Acute Professional (Olanzapine) Other (Olanzapine) PS 15 MG Depakote (Valproate Semisodium) C Date:01/15/04ISR Number: 4273870-8Report Type:Expedited (15-DaCompany Report #USA040155659 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa Zydis-Oral Initial or Prolonged Condition Aggravated (Olanzapine) Eating Disorder (Olanzapine) PS 20 MG/DAY Polydipsia Psychogenic Schizophrenia Treatment Noncompliance Vomiting Weight Decreased Date:01/15/04ISR Number: 4274603-1Report Type:Expedited (15-DaCompany Report #EWC040137515 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Foreign Zyprexa-Oral Feeling Abnormal Health (Olanzapine) Haematoma Professional (Olanzapine) PS 10 MG/DAY Syncope Company Litarex (Lithium Representative Citrate) C Other Date:01/15/04ISR Number: 4274679-1Report Type:Expedited (15-DaCompany Report #JP_031002049 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Study (Olanzapine) Meningitis Aseptic Health (Olanzapine) PS 10 MG/DAY Professional Mm C Other Gascon (Dimeticone) C Gluconsan K (Potassium Gluconate) C Mucosta (Rebamipide) C Magnesium Oxide C 24-Jun-2005 12:19 PM Page: 2740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexotan (Bromazepam) C Doral (Quazepam) C Chinese Medicine C Gasmotin (Mosapride Citrate) C Frandol (Isosorbide Dinitrate) C Paxil (Paroxetine Hydrochloride) C Date:01/15/04ISR Number: 4274717-6Report Type:Expedited (15-DaCompany Report #JP_030901726 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Zyprexa-Oral Initial or Prolonged C-Reactive Protein Health (Olanzapine) PS 10 MG/DAY Disability Increased Professional Serenace Chest Discomfort Company (Haloperidol) C Cough Representative Depas (Etizolam) C Electrocardiogram Q Wave Other Artane Abnormal (Trihehyphenidyl Malaise Hydrochloride) C Oxygen Saturation Contomin Decreased (Chlorpromazine Pco2 Decreased Hydrochloride) C Pco2 Increased Pursennide (Senna Pyrexia Leaf) C Radial Nerve Palsy Respiratory Failure Sleep Apnoea Syndrome White Blood Cell Count Increased Date:01/15/04ISR Number: 4274723-1Report Type:Expedited (15-DaCompany Report #JP_031102236 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) PS 10 MG/DAY Aspartate Professional Evamyl Aminotransferase Company (Lormetazepam) C Increased Representative Alosenn C Blood Chloride Decreased Other Magnesium Oxide C Blood Lactate Nitorol (Isosorbide Dehydrogenase Increased Dinitrate) C Blood Sodium Decreased Bayaspirin Decreased Appetite (Acetylsaliculic Gamma-Glutamyltransferase Aci) C Increased Benzalin Hepatic Function Abnormal (Nitrazepam) C Nasopharyngitis Pancytopenia Pyrexia Splenomegaly Viral Infection 24-Jun-2005 12:19 PM Page: 2741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/04ISR Number: 4274729-2Report Type:Expedited (15-DaCompany Report #JP_031202380 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Zyprexa-Oral Life-Threatening Hyperglycaemia Health (Olanzapine) PS 25 MG/DAY Hyperventilation Professional Risperdal Metabolic Acidosis Company (Risperidone) C Neuroleptic Malignant Representative Serenace Syndrome Other (Halopridol) C Rhabdomyolysis Contomin (Chlorpromazine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Rohypnol (Flunitrazepam) C Vegetamin B C Date:01/15/04ISR Number: 4274740-1Report Type:Expedited (15-DaCompany Report #FR_031203281 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Zyprexa-Oral Hospitalization - Hepatocellular Damage Health (Olanzapine) Initial or Prolonged Hyperthermia Professional (Olanzapine) PS 20 MG/DAY Other Mania Other Depakote (Valproate Renal Failure Semisodium) C Respiratory Distress Ixel (Milnacipran) C Urinary Tract Infection Anafranil (Clomipramine Hydrochloride) C Terican (Cyamemazine) C Mepronizine C Furadantine (Nitrofurantoin) C Loxapac (Loxapine Succinate C Date:01/16/04ISR Number: 4273465-6Report Type:Direct Company Report #CTU 210252 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Clonazepam 1mg Initial or Prolonged Pneumonia Aspiration Tablets PS Somnolence Olanzapine 20mg SS Divalproex 1000mg SS Beers SS Date:01/16/04ISR Number: 4273719-3Report Type:Direct Company Report #CTU 210305 Age:15 YR Gender:Male I/FU:I Outcome Disability Congenital Anomaly Other Required Intervention to 24-Jun-2005 12:19 PM Page: 2742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Zyprexa (Olanzapine) PS 10 MG Anxiety Drug Dependence Hallucination Nervous System Disorder Poisoning Rheumatoid Arthritis Date:01/16/04ISR Number: 4274884-4Report Type:Expedited (15-DaCompany Report #MK200312-0152-2 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Anafranil 25mg Initial or Prolonged Diabetic Hyperosmolar Capsules PS 3 YR Coma Olanzapine SS 3 YR Hallucination, Visual Lithium C Metabolic Acidosis Paraesthesia Pneumonia Renal Failure Rhabdomyolysis Vision Blurred Date:01/16/04ISR Number: 4274885-6Report Type:Expedited (15-DaCompany Report #MK200401-0087-1 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Anafranil Capsules PS 75 MG, TID Initial or Prolonged Blood Pressure Abnormal Zyprexa SS Cardiac Failure Tranxene Hyperhidrosis (Clorazepate Medication Error Dipotassium) C Tachypnoea Lexomil (Bromazepam) C Anafranil Iv C Date:01/20/04ISR Number: 4274508-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-355106 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Consumer Rivotril PS Roche ORAL 1 DAY Initial or Prolonged Drug Abuser Zyprexa SS ORAL 1 DAY Hypotension Tercian SS ORAL 1 DAY Overdose Cannabis C Somnolence Date:01/20/04ISR Number: 4274519-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-355106 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Consumer Rivotril PS Roche ORAL 1 DAY Initial or Prolonged Drug Abuser Zyprexa SS ORAL 1 DAY Hypotension Tercian SS ORAL 1 DAY Overdose Cannabis C Somnolence 24-Jun-2005 12:19 PM Page: 2743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/04ISR Number: 4276556-9Report Type:Expedited (15-DaCompany Report #2004001063 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Literature Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Electrocardiogram Health Haloperidol Abnormal Professional (Haloperidol) SS Hyperprolactinaemia Risperidone Psychotic Disorder (Risperidone) SS Tardive Dyskinesia Olanzapine Weight Increased (Olanzapine) SS Quetiapine (Quetiapine) SS Valproate (Valproic Acid) C Date:01/20/04ISR Number: 4276747-7Report Type:Direct Company Report #CTU 210452 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Olanzapine PS Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:01/20/04ISR Number: 4276899-9Report Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Infarction Health Olanzapine SS Required Acute Psychosis Professional Cipramil C Intervention to Cardiomyopathy Other Haloperidol C Prevent Permanent Depressed Level Of Temazepam C Impairment/Damage Consciousness Date:01/20/04ISR Number: 4277050-1Report Type:Expedited (15-DaCompany Report #2004-111457-NL Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Mirtazapine (See Increased Professional Attached Pages For Blood Bilirubin Increased Additional Suspect Drugs) PS ORAL 30 MG ORAL 1 MON Olanzapine SS ORAL 15 MG/10 MG Date:01/21/04ISR Number: 4275531-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0319879A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Consumer Clamoxyl PS Glaxosmithkline ORAL 1G Three Cyanosis times per day Death Lexomil SS ORAL .5UNIT Per day Zyprexa SS ORAL 1UNIT Per day 24-Jun-2005 12:19 PM Page: 2744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Theralene (Alimemazine) SS ORAL 10UNIT Per day Tercian SS ORAL 25UNIT Three times per day Artane SS INTRAMUSCULAR 10MG Unknown 1 DAY Risperdal C UNKNOWN 31 DAY Seropram C UNKNOWN 31 DAY Utrogestan C UNKNOWN 100MG Per day Seglor C ORAL 2UNIT per day Imovane C ORAL 1UNIT per day Date:01/21/04ISR Number: 4276458-8Report Type:Direct Company Report #CTU 210494 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Olanzapine 10 Mg Eli Intervention to Lilly PS Eli Lilly ORAL 10 MG QHS Prevent Permanent ORAL Impairment/Damage Date:01/21/04ISR Number: 4277677-7Report Type:Expedited (15-DaCompany Report #DE_030611567 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Bedridden Consumer (Olanzapine) Disease Recurrence Health (Olanzapine) PS 15 MG/DAY Drug Ineffective Professional Nizax (Nizatidine) SS International Normalised Other Risperdal Ratio Abnormal (Risperidone) C Phlebothrombosis Pulmonary Embolism Respiratory Disorder Weight Decreased Weight Increased Date:01/21/04ISR Number: 4277678-9Report Type:Expedited (15-DaCompany Report #GBS031214116 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Olanzapine-Oral Life-Threatening Health (Olanzapine) PS 5 MG Hospitalization - Professional Trazodone C Initial or Prolonged Other Simvastatin C Bricanyl (Terbutaline Sulfate) C Isosorbide Mononitrate C Paracetamol C Influenza Virus Vaccine C Perindopril C 24-Jun-2005 12:19 PM Page: 2745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/04ISR Number: 4277679-0Report Type:Expedited (15-DaCompany Report #JP_030901799 Age:2 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniotic Cavity Infection Foreign Zyprexa-Oral Initial or Prolonged Maternal Drugs Affecting Health (Olanzapine) Foetus Professional (Olanzapine) PS Neonatal Disorder Company Neonatal Tachypnoea Representative Premature Rupture Of Other Membranes Umbilical Hernia Date:01/21/04ISR Number: 4277680-7Report Type:Expedited (15-DaCompany Report #JP_031102150 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Other Circulatory Collapse Health (Olanzapine) Dizziness Professional (Olanzapine) PS 5 MG/3 DAY Loss Of Consciousness Company Wypax (Lorazepam) C Myocardial Infarction Representative Benzalin Other (Nitrazepam) C Hirnamin (Levomepromazine) C Silece (Flunitrazepam) C Eurodin (Estazolam) C Date:01/21/04ISR Number: 4277681-9Report Type:Expedited (15-DaCompany Report #GBS031114006 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Foreign Zyprexa-Oral Living Impaired Consumer (Olanzapine) Aggression Health (Olanzapine) PS 7.5 MG/DAY Alcoholism Professional Amisulpride C Amnesia Other Sulpiride C Chest Pain Quetiapine C Choking Cognitive Disorder Disturbance In Attention Dysgraphia Haemorrhoids Homeless Loss Of Libido Marital Problem Muscle Spasms Rectal Haemorrhage Somnolence Tardive Dyskinesia Tic Tongue Oedema Unemployment 24-Jun-2005 12:19 PM Page: 2746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/04ISR Number: 4277717-5Report Type:Expedited (15-DaCompany Report #DE_040112705 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Other Vomiting Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY 1 YR Company Fluanxol Representative (Flupentixol Other Hydrochloride) C Date:01/21/04ISR Number: 4278293-3Report Type:Expedited (15-DaCompany Report #JP_031202380 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Zyprexa-Oral Life-Threatening Blood Pressure Decreased Health (Olanzapine) Blood Urea Increased Professional (Olanzapine) PS 25 MG/DAY Dehydration Company Risperdal Diabetes Mellitus Representative (Risperidone) C Fall Other Serenace Haemodialysis (Haloperidol) C Metabolic Acidosis Contomin Neuroleptic Malignant (Chlorpromazine Syndrome Hydrochloride) C Platelet Count Decreased Akineton (Biperiden Rhabdomyolysis Hydrochloride) C Rohypnol (Flunitrazepam) C Vegetamin B C Date:01/21/04ISR Number: 4278313-6Report Type:Expedited (15-DaCompany Report #USA031255464 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:01/21/04ISR Number: 4278318-5Report Type:Expedited (15-DaCompany Report #USA040155767 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 2 YR Other Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Haldol (Haloperidol) C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/04ISR Number: 4278319-7Report Type:Expedited (15-DaCompany Report #USA040155822 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa-Oral Initial or Prolonged Blood Glucose Increased Professional (Olanzapine) Mental Disorder Due To A Company (Olanzapine) PS General Medical Condition Representative Date:01/21/04ISR Number: 4278321-5Report Type:Expedited (15-DaCompany Report #USA040155894 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa - Oral Decreased Appetite (Olanzapine) Dizziness (Olanzapine) PS 2 WK Homicidal Ideation Strattera Off Label Use (Atomoxetine Peripheral Coldness Hydrochloride) SS 60 MG/DAY Poor Peripheral Depakote (Valproate Circulation Semisodium) C Pulse Abnormal Tegretal Skin Discolouration (Carbamazepine) C Tachycardia Date:01/21/04ISR Number: 4278323-9Report Type:Expedited (15-DaCompany Report #USA040155916 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Zyprexa -Oral Myocardial Infarction Professional (Olanzapine) Company (Olanzapine) PS 5 MG/IN THE Representative EVENING 1 DAY Date:01/21/04ISR Number: 4279010-3Report Type:Expedited (15-DaCompany Report #USA030946603 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa-Oral Coma Professional (Olanzapine) Loss Of Consciousness Company (Olanzapine) PS Respiratory Depression Representative Valium (Diazepam) C Duragesic (Fentanyl) C Date:01/21/04ISR Number: 4279011-5Report Type:Expedited (15-DaCompany Report #US_030997665 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa-Oral Other Drug Level Increased Health (Olanzapine) Hypertrophic Professional (Olanzapine) PS 7.5 MG Cardiomyopathy Other Adderall Xr C Pulmonary Congestion Ativan (Lorazepam) C Pulmonary Oedema Celexa (Citalopram Respiratory Arrest Hydrobromide) C Respiratory Depression Cyclobenzaprine C Respiratory Failure 24-Jun-2005 12:19 PM Page: 2748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/04ISR Number: 4279012-7Report Type:Expedited (15-DaCompany Report #US_030795917 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Consumer Zyprexa-Oral Cerebrovascular Accident (Olanzapine) Diabetes Mellitus (Olanzapine) PS 5 MG/DAY Diverticulum Lopid (Gemfibrozil) C Gastrointestinal Valium (Diazepam) C Haemorrhage Aspirin C Haemorrhoidal Haemorrhage Glucotrol Xl International Normalised (Glipizide) C Ratio Decreased Accupril (Quinapril Ketoacidosis Hydrochloride) C Pancreatitis Hydrochlorothiazide C Pneumonia Mycoplasmal Glucophage Prothrombin Time (Metformin Prolonged Hydrochloride) C Red Blood Cell Count Lipitor Decreased (Atorvastatin) C Toprol Xl (Metoprolol Succinate) C Date:01/22/04ISR Number: 4277461-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-355726 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Consumer Loxen PS Roche ORAL Initial or Prolonged Complete Eupressyl SS ORAL Bradycardia Zyprexa SS ORAL Depakine Chrono SS ORAL Date:01/22/04ISR Number: 4278210-6Report Type:Direct Company Report #CTU 210673 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Zyprexa 5mg Lilly PS Lilly ORAL 5 MG QID PO Initial or Prolonged Neuroleptic Malignant Syndrome Pneumonia Date:01/22/04ISR Number: 4278226-XReport Type:Direct Company Report #CTU 210679 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Chloral Hydrate 500 -1500mg Hs PS 3 DOSES Zyprexa 15 Mg Po SS ORAL 2 DOSES Date:01/26/04ISR Number: 4280168-0Report Type:Expedited (15-DaCompany Report #A124796 Age:46 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Anger Blood Cholesterol Increased 24-Jun-2005 12:19 PM Page: 2749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Burning Sensation Chest Pain Constipation Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Fatigue Health ORAL Fear Professional Olanzapine Heart Rate Decreased (Olanzapine) SS Heart Rate Increased Valproate Semisodium Hostility (Valproate Insomnia Semisodium) SS ORAL ORAL Muscle Tightness Lamotrigine Musculoskeletal Stiffness (Lamotrigine) SS ORAL 250 MG (BID), Nausea ORAL Nightmare Diphenhydramine Palpitations Hydrochloride Personality Change (Diphenhydramine Phobia Hydrochloride) C Physical Assault Calcium (Calcium) C Rash Levothyroxine Rash Erythematous (Levothyuroxine) C Rhinorrhoea Tolterodine Somnolence L-Tartrate Speech Disorder (Tolterodine Stupor L-Tartrate) C Swelling Calcitriol Tension (Calcitriol) C Tremor Risperidone (Risperidone) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:01/26/04ISR Number: 4280325-3Report Type:Expedited (15-DaCompany Report #2003-110416-NL Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Foreign Mirtazapine PS ORAL 30 MG/45 MG, Parkinsonism Health ORAL Professional Olanzapine SS ORAL ORAL 9 DAY Other Amisulfride SS ORAL 100 MG, ORAL 3 DAY Hexachlrophene C Potassium Chloride C Heparin-Fraction, Sodium Salt C Movicol C Date:01/26/04ISR Number: 4296488-XReport Type:Periodic Company Report #USA030845198 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Drug Interaction (Atomoxetine Dyspepsia Hydrochloride) PS 60 MG/DAY Fatigue Zyprexa-Oral Headache (Olanzapine) Hypersomnia (Olanzapine) SS Nausea Somnolence 24-Jun-2005 12:19 PM Page: 2750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/04ISR Number: 4296821-9Report Type:Periodic Company Report #USA030741739 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Weight Increased (Atomoxetine Hydrochloride) PS 50 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Zoloft (Sertraline Hydrochloride) C Tenex (Guanfacine Hydrochloride) C Date:01/26/04ISR Number: 4297686-1Report Type:Periodic Company Report #USA031151487 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa-Oral Gait Disturbance Professional (Olanzapine) Muscle Twitching Company (Olanzapine) PS 20 MG/DAY Orthostatic Hypotension Representative Strattera (Atomoxetine Hydrochloride) SS 80 MG/DAY Celexa (Citalopram Hydrobromide) C Date:01/26/04ISR Number: 4302358-0Report Type:Periodic Company Report #USA031049592 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa-Oral Drug Ineffective (Olanzapine) Flushing (Olanzapine) PS 2.5 MG/ DAY Increased Appetite Strattera Somnolence (Atomoxetine Weight Increased Hydrochloride) SS Date:01/26/04ISR Number: 4303073-XReport Type:Periodic Company Report #USA031050245 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Strattera Dizziness (Atomoxetine Dry Mouth Hydrochloride) PS Dysgeusia Zyprexa-Oral Dysuria (Olanzapine) Fatigue (Olanzapine) SS Feeling Abnormal Nausea Oedema Tension Headache Weight Increased 24-Jun-2005 12:19 PM Page: 2751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/04ISR Number: 4303094-7Report Type:Periodic Company Report #USA030948549 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Strattera Cognitive Disorder (Atomoxetine Disturbance In Attention Hydrochloride) PS 25 MG/DAY Drug Ineffective Zyprexa-Oral Increased Appetite (Olanzapine) Weight Increased (Olanzapine) SS 5 MG/AT BEDTIME Concerta (Methylphenidate Hydrochloride) C Date:01/27/04ISR Number: 4279375-2Report Type:Expedited (15-DaCompany Report #WAES 0307DEU00072 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Vioxx PS Merck & Co., Inc ORAL Life-Threatening Dialysis Professional Vasotec SS ORAL Hospitalization - Drug Interaction Esomeprazole Initial or Prolonged Duodenal Ulcer Magnesium SS ORAL Haemorrhage Furosemide Sodium SS ORAL Renal Failure Vioxx SS Merck & Co., Inc ORAL Olanzapine SS ORAL Risperidone SS ORAL Date:01/29/04ISR Number: 4281911-7Report Type:Expedited (15-DaCompany Report #PHBS2004ES01127 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Trileptal PS Novartis Sector: Pharma ORAL 300 mg/day Zyprexa SS ORAL 5 mg/day 76320MIN Topamax SS ORAL 50 mg/day 41760MIN Fluoxetine C UNKNOWN Date:01/29/04ISR Number: 4283237-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040103756 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Neutropenia Health (Risperidone) Professional Tablets PS ORAL 4 MG, IN 1 DAY, ORAL Zyprexa (Olanzapine) SS Date:01/30/04ISR Number: 4283760-2Report Type:Direct Company Report #CTU 211146 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Zyprexa 20 Mg PS ORAL 20 MG QHS Initial or Prolonged Non-Insulin-Dependent ORAL Hyperglycaemia 24-Jun-2005 12:19 PM Page: 2752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/04ISR Number: 4283995-9Report Type:Expedited (15-DaCompany Report #US_030493932 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa-Oral Overdose Professional (Olanzapine) Company (Olanzapine) PS 50 MG/DAY Representative Date:01/30/04ISR Number: 4283997-2Report Type:Expedited (15-DaCompany Report #US_030393671 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Sinusitis Consumer Zyprexa-Oral Initial or Prolonged Angina Pectoris (Olanzapine) Blood Calcium Decreased (Olanzapine) PS Blood Glucose Increased Glucophage(Metformin Blood Urea Decreased Hydrochloride) C Bronchitis Glucotrol Diabetes Mellitus (Glipizide) C Diarrhoea Haemorrhagic Zantac(Ranitidine Endometriosis Hydrochloride) C Gastrooesophageal Reflux Zoloft (Sertraline Disease Hydrochloride) C Haematuria Xenical(Orlistat) C Hepatic Steatosis Multivitamin C Medication Error Diazepam C Nausea Navane(Tiotixene) C Nephrolithiasis Pain Pleurisy Renal Colic Urinary Retention Vaginal Mycosis Vomiting Weight Increased Date:01/30/04ISR Number: 4283998-4Report Type:Expedited (15-DaCompany Report #USA031254938 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa-Oral Initial or Prolonged Drug Abuser Professional (Olanzapine) Other Intentional Misuse Company (Olanzapine) PS 20 MG Representative Depakote (Valproate Semisodium) C Trileptal (Oxcarbazepine) C Date:01/30/04ISR Number: 4284338-7Report Type:Expedited (15-DaCompany Report #USA031254272 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Health Zyprexa-Oral Exposure To Therapeutic Professional (Olanzapine) Drugs Company (Olanzapine) PS Intra-Uterine Death Representative Ativan (Lorazepam) C Maternal Drugs Affecting Prenatal Vitamins C Foetus Nicorette 24-Jun-2005 12:19 PM Page: 2753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gum(Nicotine Resin) C Ensure C Colace (Docusate Sodium) C Date:01/30/04ISR Number: 4284339-9Report Type:Expedited (15-DaCompany Report #USA030946396 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Effect Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:01/30/04ISR Number: 4284373-9Report Type:Expedited (15-DaCompany Report #USA040156502 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa Hospitalization - Apallic Syndrome Professional Zydis-Dispersible Initial or Prolonged Cardio-Respiratory Arrest (Olanzapine) Other Depressed Level Of (Olanzapine) PS 20 MG/2 DAY Consciousness Risperdal Dyspnoea (Risperidone) C Ativan (Lorazepam) C Date:01/30/04ISR Number: 4284375-2Report Type:Expedited (15-DaCompany Report #USA040156454 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Zyprexa-Oral Other Sepsis Professional (Olanzapine) Company (Olanzapine) PS 3 DAY Representative Date:01/30/04ISR Number: 4284376-4Report Type:Expedited (15-DaCompany Report #USA040156450 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa-Oral Initial or Prolonged Apnoea (Olanzapine) Blood Pressure Decreased (Olanzapine) PS 1.25 MG/IN Feeling Abnormal THE EVENING Feeling Cold Zoloft (Sertraline Grand Mal Convulsion Hydrochloride) C Influenza Movement Disorder Pyrexia Respiration Abnormal Respiratory Rate Decreased Tachycardia Tremor 24-Jun-2005 12:19 PM Page: 2754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/04ISR Number: 4284378-8Report Type:Expedited (15-DaCompany Report #USA040156366 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Movement Disorder Consumer Zyprexa-Oral Initial or Prolonged Pyrexia (Olanzapine) (Olanzapine) PS 5 MG/DAY Diovan (Valsartan) C Digoxin C Date:01/30/04ISR Number: 4284380-6Report Type:Expedited (15-DaCompany Report #USA040156147 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa - Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG/DAY Representative Effexor (Venlafaxine Hydrochloride) C Remeron (Mirtazapine) C Date:01/30/04ISR Number: 4284381-8Report Type:Expedited (15-DaCompany Report #USA040155983 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Zyprexa-Oral Initial or Prolonged Condition Aggravated (Olanzapine) Panic Attack (Olanzapine) PS 20 MG/AT Weight Increased BEDTIME Avandia (Rosiglitazone Maleate) C Lopressor (Metoprolol Tartrate) C Accolate (Zafirlukast) C Lasix (Furosemide) C Synthroid (Levothyroxine Sodium) C Lanoxin (Digoxin) C Enalapril C Aspirin C Nitroglycerin (Glyceryl Trinitrate) C Lipitor (Atorvastatin) C Trileptal (Oxcarbazepine) C Ambien (Zolpidem Tartrate) C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Cogentin (Benzatropine 24-Jun-2005 12:19 PM Page: 2755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Zoloft (Sertraline Hydrochloride) C Date:01/30/04ISR Number: 4284538-6Report Type:Expedited (15-DaCompany Report #JP_040102495 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Risperdal Representative (Risperidone) C Other Silece (Flunitrazepam) C Akineton (Biperiden Hydrochloride) C Date:01/30/04ISR Number: 4284540-4Report Type:Expedited (15-DaCompany Report #GBS040114273 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gingival Bleeding Foreign Zyprexa-Oral Gingival Swelling Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:01/30/04ISR Number: 4284541-6Report Type:Expedited (15-DaCompany Report #GBS040114265 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Epilim (Valproate Company Sodium) C Representative Efexor (Venlafaxine Other Hydrochloride) C Date:01/30/04ISR Number: 4284552-0Report Type:Expedited (15-DaCompany Report #USA031152400 Age:55 YR Gender:Male I/FU:I Outcome PT Life-Threatening Agitation Hospitalization - Cognitive Disorder Initial or Prolonged Coma Other Delirium Diabetes Mellitus Diarrhoea Disorientation Drug Toxicity Hyperglycaemia Mental Status Changes Neuroleptic Malignant Syndrome Polydipsia Polyuria 24-Jun-2005 12:19 PM Page: 2756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Respiratory Failure Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine ) PS 20 MG/DAY Company Depakote (Valproate Representative Semisodium) C Lithium C Potassium C Date:01/30/04ISR Number: 4284556-8Report Type:Expedited (15-DaCompany Report #DSA_23858_2004 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Tavor PS ORAL 0.5 MG Q DAY Initial or Prolonged Increased Health PO Leukopenia Professional Zyprexa SS ORAL 10 MG Q DAY Neutropenia Other PO Zoloft SS ORAL 100 MG Q DAY PO Date:01/30/04ISR Number: 4284602-1Report Type:Expedited (15-DaCompany Report #FR_040103434 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Decreased Foreign Zyprexa-Oral Hypercholesterolaemia Health (Olanzapine) Hypertriglyceridaemia Professional (Olanzapine) PS 10 MG/DAY Medication Error Company Weight Increased Representative Other Date:01/30/04ISR Number: 4284603-3Report Type:Expedited (15-DaCompany Report #FR_040103388 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Hypothermia Health (Olanzapine) Professional (Olanzapine) PS 10 MG/DAY Other Date:01/30/04ISR Number: 4284605-7Report Type:Expedited (15-DaCompany Report #FR_040103402 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Zyprexa-Oral Initial or Prolonged Myoglobinuria Health (Olanzapine) Pyrexia Professional (Olanzapine) PS UNKNOWN UNK Renal Failure Acute Other Date:01/30/04ISR Number: 4284622-7Report Type:Expedited (15-DaCompany Report #DE_031012198 Age:76 YR Gender:Male I/FU:I Outcome PT Hospitalization - Neuroleptic Malignant Initial or Prolonged Syndrome 24-Jun-2005 12:19 PM Page: 2757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) PS 10 MG/DAY Professional Levodopa C Company Pantozol Representative (Pantoprazole Other Sodium) C Lasix (Furosemide) C Stilnox (Zolpidem) C Tavor (Lorazepam) C Date:01/30/04ISR Number: 4284727-0Report Type:Expedited (15-DaCompany Report #JP_031202320 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Hospitalization - Condition Aggravated Health (Olanzapine) PS 5 MG/DAY Initial or Prolonged Drug Ineffective Professional Thyradin S Other Hypertension Company (Levothyroxine Irritability Representative Sodium) C Logorrhoea Other Lullan (Perosirone Malaise Hydrochloride) C Pulse Absent Tasmolin (Biperiden) C Respiratory Arrest Atarax-P Weight Increased (Hydroxyzine Hydrochloride) C Rohipnol (Flunitrazepam) C Benzalin (Nitrazepam) C Pursennid (Senna Leaf) C Date:01/30/04ISR Number: 4284728-2Report Type:Expedited (15-DaCompany Report #JP_031102236 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) PS 10 MG/DAY Aspartate Professional Evamyl Aminotransferase Company (Lormetazepam) C Increased Representative Alosenn C Blood Lactate Other Magnesium Oxide C Dehydrogenase Increased Nitorol (Isosorbide Blood Sodium Decreased Dinitrate) C Decreased Appetite Bayaspirin Gamma-Glutamyltransferase (Acetylsalicylic Increased Acid) C Hepatic Function Abnormal Benzalin Influenza (Nitrazepam) C Nasopharyngitis Pancytopenia Splenomegaly 24-Jun-2005 12:19 PM Page: 2758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/04ISR Number: 4284729-4Report Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abulia Foreign Zyprexa-Oral Hospitalization - Anxiety Health (Olanzapine) PS 10 MG/DAY Initial or Prolonged Aphagia Professional Serenace Other Body Temperature Company (Haloperidol) C Decreased Representative Catheter Related Other Infection Condition Aggravated Decreased Appetite Dehydration Depressed Level Of Consciousness Diabetic Coma Diabetic Ketoacidosis Diet Refusal Fear Of Disease Haemodialysis Heart Rate Increased Hyperglycaemia Hyperventilation Hypotension Inflammation Metabolic Acidosis Nausea Obesity Pneumonia Staphylococcal Psychotic Disorder Pyrexia Renal Failure Acute Respiratory Alkalosis Staphylococcal Infection Tachypnoea Thirst Urinary Tract Infection Vomiting White Blood Cell Count Decreased Date:01/30/04ISR Number: 4284730-0Report Type:Expedited (15-DaCompany Report #JP_030901799 Age:2 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) PS Maternal Drugs Affecting Professional Foetus Company Neonatal Disorder Representative Neonatal Infection Other Respiratory Disorder Neonatal Tachypnoea Umbilical Hernia 24-Jun-2005 12:19 PM Page: 2759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/04ISR Number: 4284731-2Report Type:Expedited (15-DaCompany Report #EWC031036780 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa-Oral Initial or Prolonged Coma Health (Olanzapine) PS 15 MG/DAY Hepatic Enzyme Increased Professional Tavor (Lorazepam) C Influenza Company Carbamazepine C Ketoacidosis Representative Myalgia Other Pyrexia Renal Failure Treatment Noncompliance Date:01/30/04ISR Number: 4284732-4Report Type:Expedited (15-DaCompany Report #DE_031012203 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Zyprexa-Oral Initial or Prolonged Dehydration Health (Olanzapine) PS 15 MG/DAY Fall Professional Pipamperone C Gait Disturbance Company Hyperhidrosis Representative Pyrexia Other Restlessness Rhabdomyolysis Tachycardia Date:01/30/04ISR Number: 4284759-2Report Type:Expedited (15-DaCompany Report #JP_030400671 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Olanzapine-Oral Initial or Prolonged Delusion Study (Olanzapine) PS 10 MG/1 DAY Hallucination Health Zotepine C Rash Professional Biperiden C Urinary Retention Other Flunitrazepam C Brotizolam C Timiperone C Alprazolam C Chlorpromazine C Date:02/03/04ISR Number: 4285170-0Report Type:Direct Company Report #CTU 211396 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Zyprexa 10 Mg Qhs PS ORAL PO 10 MG QHS 2 MON Concerta C Depakote C Trazadone C Tenex C Date:02/05/04ISR Number: 4285921-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0320863A Age: Gender:Female I/FU:I Outcome PT Hospitalization - Decreased Activity Initial or Prolonged Depressed Level Of 24-Jun-2005 12:19 PM Page: 2760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Exanthem Fall Gait Disturbance Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Health Lamictal PS Glaxosmithkline ORAL 1U per day 20 DAY Haemothorax Professional Escitalopram SS ORAL 1U per day 77 DAY Rib Fracture Lorazepam SS ORAL 1U per day 34 DAY Sedation Olanzapine SS ORAL 1U per day 24 DAY White Blood Cell Count Mirtazapine SS UNKNOWN Decreased Date:02/05/04ISR Number: 4286246-4Report Type:Direct Company Report #CTU 211610 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dependence Zyprexa PS Insomnia Prozac SS Obesity Date:02/05/04ISR Number: 4286437-2Report Type:Direct Company Report #CTU 211633 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Zyprexa - Unknown Distress Syndrome Dose PS ORAL UNKNOWN Aspiration ORALLY 2 WK Asthenia Buspar C Candidiasis Kcl C Fungal Sepsis Atenolol C Insomnia Klonopin C Malaise Lexapro C Medication Error Benadryl C Neutropenia Pharyngolaryngeal Pain Pyrexia Date:02/05/04ISR Number: 4286472-4Report Type:Direct Company Report #CTU 211649 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Zyprexa (Olanzapine) Hospitalization - Lethargy Eli Lilly 2.5 Mg PS Eli Lilly ORAL 2.5 MG PO QHS Initial or Prolonged Pulmonary Oedema Levaquin Required Thrombocytopenia (Levofloxacin) Ortho Intervention to Urinary Tract Infection Mcneil 250 Mg SS Ortho Mcneil ORAL 250 MG PO QD Prevent Permanent Coumadin C Impairment/Damage Furosemide C Isosorbide Mononitrate C Lisinopril C Metoprolol Xl C Protonix C Prednisone C B12 C Iron Sulfate C Calcium Carbonate W/Vitd C Kcl C 24-Jun-2005 12:19 PM Page: 2761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4287408-2Report Type:Expedited (15-DaCompany Report #USA031255464 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Health Zyprexa Hypersensitivity Professional Zydis-Dispersible Oedema Peripheral Company (Olanzapine)(Olanzap Pyrexia Representative ine) PS Rash Skin Discolouration Date:02/05/04ISR Number: 4287416-1Report Type:Expedited (15-DaCompany Report #US_030795917 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Consumer Zyprexa-Oral Initial or Prolonged Cerebrovascular Accident Health (Olanzapine) Other Colonic Polyp Professional (Olanzapine) PS 5MG/DAY Diabetes Mellitus Lopid (Gemfibrozil) C Inadequate Control Valium (Diazepam) C Diabetes Mellitus Aspirin (E.C.) Non-Insulin-Dependent (Acetylsalicylic Dilatation Atrial Acid) C Diverticulum Glucotrol Xl Fatigue (Glipizide) C Gastrointestinal Accupril (Quinapril Haemorrhage Hydrochloride) C Haematocrit Decreased Hydrochlorothiazide C Haemoglobin Decreased Glucophage Haemorrhoidal Haemorrhage (Metformin International Normalised Hydrochloride) C Ratio Decreased Lipitor Ketoacidosis (Atorvastatin) C Pancreatitis Toprol Xl Pneumonia Mycoplasmal (Metoprolol Prothrombin Time Succinate) C Prolonged Xanax (Alprazolam) C Red Blood Cell Count Decreased Somnolence Stomatitis Ventricular Hypertrophy Weight Increased Date:02/05/04ISR Number: 4287417-3Report Type:Expedited (15-DaCompany Report #USA030640332 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Consumer Zyprexa-Oral Atherosclerosis (Olanzapine) Food Craving (Olanzapine) PS 30 MG/DAY 2 YR Insomnia Gabapentin C Sleep Disorder Trazodone C Somnolence Vascular Occlusion Weight Increased 24-Jun-2005 12:19 PM Page: 2762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4287747-5Report Type:Expedited (15-DaCompany Report #US_031199068 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Refusal Of Treatment By Consumer Zyprexa-Oral Patient Health (Olanzapine)(Olanzap Professional ine) PS 15 MG/DAY Seruquel (Quetiapine Fumarate) C Ativan (Lorazepam) C Vistaril (Hydroxyzine Embonate) C Depo Provera (Medroxyprogesterone Acetate) C Date:02/05/04ISR Number: 4287819-5Report Type:Expedited (15-DaCompany Report #US_0401100016 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vaginal Haemorrhage Consumer Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS Date:02/05/04ISR Number: 4287829-8Report Type:Expedited (15-DaCompany Report #USA031255473 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Consumer Zyprexa-Oral Epistaxis (Olanzapine) Headache (Olanzapine) PS 15 MG/DAY Hypoaesthesia Weight Decreased Weight Increased Date:02/05/04ISR Number: 4287832-8Report Type:Expedited (15-DaCompany Report #USA040156941 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Consumer Zyprexa-Oral Liver Disorder (Olanzapine) (Olanzapine) PS Date:02/05/04ISR Number: 4287834-1Report Type:Expedited (15-DaCompany Report #USA040156904 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cleft Lip Health Zyprexa-Oral Maternal Drugs Affecting Professional (Olanzapine) Foetus Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4287849-3Report Type:Expedited (15-DaCompany Report #USA040156602 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Zyprexa-Oral Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG/DAY Representative Strattera (Atomoxetine Hydrochloride) SS 80 MG/DAY Wellbutrin (Bupropion Hydrochloride) C Neurontin (Gabapentin) C Date:02/05/04ISR Number: 4288508-3Report Type:Expedited (15-DaCompany Report #JP_040102515 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Death Of Sibling Health (Olanzapine) Social Problem Professional (Olanzapine) PS Company Depakene (Valproate Representative Sodium) C Other Date:02/05/04ISR Number: 4288510-1Report Type:Expedited (15-DaCompany Report #FR_040103431 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholestasis Foreign Zyprexa-Oral Fungal Oesophagitis Health (Olanzapine) Oral Fungal Infection Professional (Olanzapine) PS 40 MG/DAY Other Largactil (Chlorpromazine Hydrochloride) C Loxapac (Loxapine Succinate) C Teralithe (Lithium Carbonate) C Date:02/05/04ISR Number: 4288512-5Report Type:Expedited (15-DaCompany Report #FR_040103416 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Zyprexa-Oral Electrocardiogram Pr Health (Olanzapine) Shortened Professional (Olanzapine) PS 30 MG/DAY Prescribed Overdose Company Nozinan Wolff-Parkinson-White Representative (Levomepromazine) C Syndrome Other Depakine Chrono C Valium (Diazepam) C Parkinane (Trihexyphenidyl Hydrochloride) C Efferalgan Codeine C 24-Jun-2005 12:19 PM Page: 2764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4288513-7Report Type:Expedited (15-DaCompany Report #EWC040137766 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Muscle Rigidity Foreign Olanzapine-Oral Pulmonary Embolism Health (Olanzapine) PS 5 MG/DAY 1 WK Skin Discolouration Professional Depakine (Valproate Company Sodium) C Representative Tranxene Other (Clorazepate Dipotassium) C Date:02/05/04ISR Number: 4288515-0Report Type:Expedited (15-DaCompany Report #JP_040102495 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Scab Health (Olanzapine) Professional (Olanzapine) PS Company Risperdal Representative (Risperidone) C Other Silece (Flunitrazepam) C Akineton (Biperiden Hydrochloride) C Date:02/05/04ISR Number: 4288681-7Report Type:Expedited (15-DaCompany Report #JP_031202405 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa-Oral Completed Suicide Health (Olanzapine) PS 15 MG/DAY Hepatic Function Abnormal Professional Hirnamin Injury Asphyxiation Company (Levomepromazine) C Soliloquy Representative Impromen Other (Bromperidol) C Mucosolvan (Ambroxol Hydrochloride) C Theodur (Theophylline) C Pakisonal (Trihexyphenidyl Hydrochloride) C Tasmolin (Biperiden) C Date:02/05/04ISR Number: 4288687-8Report Type:Expedited (15-DaCompany Report #JP_031202320 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Hospitalization - Condition Aggravated Health (Olanzapine) PS 5 MG/DAY Initial or Prolonged Disease Recurrence Professional Thyradin S Other Drug Ineffective Company (Levothyroxine Hypertension Representative Sodium) C Irritability Other Lullan (Perospirone Logorrhoea Hydrochloride) C Malaise Tasmolin (Biperiden) C Weight Increased Atarax-P (Hydroxyzine 24-Jun-2005 12:19 PM Page: 2765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Rohipnol (Flunitrazepam) C Benzalin (Nitrazepam) C Pursennid (Senna Leaf) C Date:02/05/04ISR Number: 4288689-1Report Type:Expedited (15-DaCompany Report #JP_031102236 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Foreign Zyprexa-Oral Initial or Prolonged Blood Cholinesterase Health (Olanzapine) PS 10 MG/DAY Decreased Professional Evamyl Blood Sodium Decreased Company (Lormetazepam) C C-Reactive Protein Representative Alosenn C Increased Other Magnesium Oxide C Cytomegalovirus Antibody Nitorol (Isosorbide Positive Dinitrate) C Decreased Appetite Bayaspirin Epstein-Barr Virus (Acetylsalicylic Antibody Positive Acid) C Hepatic Function Abnormal Benzalin Lymphocyte Morphology (Nitrazepam) C Abnormal Lymphoproliferative Disorder Marrow Hyperplasia Nasopharyngitis Pancytopenia Pyrexia Splenomegaly Date:02/05/04ISR Number: 4288692-1Report Type:Expedited (15-DaCompany Report #EWC031137136 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Olanzapine-Oral Dehydration Health (Olanzapine) PS 10 MG/DAY Myocardial Infarction Professional Clomipramine C Oedema Peripheral Other Date:02/05/04ISR Number: 4288693-3Report Type:Expedited (15-DaCompany Report #EWC031036699 Age:82 YR Gender:Female I/FU:F Outcome PT Death Acidosis Hospitalization - Agitation Initial or Prolonged Chronic Myeloid Leukaemia Other Coma Condition Aggravated Confusional State Disseminated Intravascular Coagulation Drug Interaction Fibrin D Dimer Increased Leukaemia Recurrent Leukaemoid Reaction 24-Jun-2005 12:19 PM Page: 2766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Count Decreased Pulmonary Embolism Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Tachypnoea Foreign Zyprexa-Oral White Blood Cell Count Health (Olanzapine) PS 5 MG/DAY Decreased Professional Levosulpiride C Company Difosfonal Representative (Clodronate Other Disodium) C Calcium C Steroids C Date:02/05/04ISR Number: 4288844-0Report Type:Expedited (15-DaCompany Report #EWC040137741 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Foreign Olanzapine-Oral Road Traffic Accident Health (Olanzapine) PS 40 MG/DAY Professional Company Representative Date:02/05/04ISR Number: 4288846-4Report Type:Expedited (15-DaCompany Report #EWC040137666 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Zyprexa-Oral Alcohol Use Health (Olanzapine) PS Professional Nozinan Other (Levomepromazine) C Tegretol (Carbamazepine) C Remeron (Mirtazapine) C Date:02/05/04ISR Number: 4288848-8Report Type:Expedited (15-DaCompany Report #DE_040112803 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged C-Reactive Protein Health (Olanzapine) PS 5 MG/3 DAY Increased Professional Orfiril (Valproate Chills Company Sodium) C Hyperhidrosis Representative Neutrophil Count Other Decreased Pallor Red Blood Cell Count Decreased White Blood Cell Count Decreased 24-Jun-2005 12:19 PM Page: 2767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4288850-6Report Type:Expedited (15-DaCompany Report #DE_040112720 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) PS 40 MG/DAY Aspartate Professional Tavor (Lorazepam) C Aminotransferase Other Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Date:02/05/04ISR Number: 4288853-1Report Type:Expedited (15-DaCompany Report #DE_031212551 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) PS 5 MG/DAY Aspartate Professional Citalopram C Aminotransferase Other Risperdal Increased (Risperidone) C Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased Mononucleosis Syndrome Date:02/05/04ISR Number: 4288856-7Report Type:Expedited (15-DaCompany Report #CA_040106573 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) PS Professional Clopixol Acuphase Company (Zuclopenthixol Representative Acetate) C Other Date:02/06/04ISR Number: 4286772-8Report Type:Expedited (15-DaCompany Report #BE-ROCHE-258230 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Health Peg-Interferon Alfa Consciousness Professional 2a (Ro 25-8310) PS Roche SUBCUTANEOUS 58 DAY Overdose Peg-Interferon Alfa Paranoia 2a (Ro 25-8310) SS Roche SUBCUTANEOUS 49 DAY Suicide Attempt Ribavirin SS Roche ORAL 107 DAY Nozinan SS ORAL Zyprexa SS ORAL Zyprexa SS ORAL Staurodorm SS Roche ORAL 24-Jun-2005 12:19 PM Page: 2768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/04ISR Number: 4290801-5Report Type:Direct Company Report #CTU 211794 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Zyprexa 7.5 Mg Q H.S PS ORAL 7.5 MG PO Q Initial or Prolonged Consciousness HS 2 DAY Buspar 15 Mg Bid SS 15 MG PO BID Celebrex C Levoxyl C Macrobid C Date:02/09/04ISR Number: 4288624-6Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0042782A Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Health Quilonum Retard PS Glaxosmithkline ORAL 45000TAB per Hospitalization - Aspiration Professional day Initial or Prolonged Blood Creatine Trimipramine SS ORAL 5000MG per Phosphokinase Increased day Bowel Sounds Abnormal Zyprexa SS ORAL 56TAB per day Coma Completed Suicide Death Pyrexia Shock Vomiting Date:02/09/04ISR Number: 4289113-5Report Type:Direct Company Report #CTU 211828 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Zyprexa 5 Mg Lilly PS Lilly ORAL 5-10 MG Neuroleptic Malignant BID/PRN ORAL Syndrome Lorazepam C Levofloxacin C Aspirin C Diphenhydramine C Benztropine C Vancyclovir C Prednisone C Ceftriaxone C Prevacid C Date:02/09/04ISR Number: 4289294-3Report Type:Direct Company Report #CTU 211875 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Olanzapine 10 Mg Eli Initial or Prolonged Syndrome Lilly PS Eli Lilly ORAL 10 MG BID Rhabdomyolysis ORAL Date:02/09/04ISR Number: 4290428-5Report Type:Expedited (15-DaCompany Report #DSA_23807_2004 Age:27 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Fatigue 24-Jun-2005 12:19 PM Page: 2769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gamma-Glutamyltransferase Increased Intentional Misuse Report Source Product Role Manufacturer Route Dose Duration Foreign Tavor PS Health Geodon SS Professional Zyprexa SS Other Date:02/09/04ISR Number: 4290437-6Report Type:Expedited (15-DaCompany Report #S04-SWI-00443-01 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Cipralex Initial or Prolonged Aminotransferase Health (Escitalopram) PS ORAL 5 MG QD PO Increased Professional Cipralex C-Reactive Protein Other (Escitalopram) SS ORAL 10 MG QD PO Increased Cipralex Depressed Level Of (Escitalopram) SS ORAL 10 MG QD PO Consciousness Cipralex Dermatitis Allergic (Escitalopram) SS ORAL 15 MG QD PO Difficulty In Walking Lamictal "Burroughs Exanthem Wellcome" Fall (Lamotrigine) SS "Burroughs Wellcome" ORAL 100 MG QD PO Haematocrit Decreased Lamictal "Burroughs Haemoglobin Decreased Wellcome" Haemothorax (Lamotrigine) SS Burroughs Wellcome Leukopenia Zyprexa (Olanzapine) SS ORAL 2.5 MG QD PO Oral Intake Reduced Zyprexa (Olanzapine) SS ORAL 5 MG QD PO Pruritus Remeron Rib Fracture (Mirtazapine) C Wheelchair User Temesta (Lorazepam) C Date:02/11/04ISR Number: 4293878-6Report Type:Expedited (15-DaCompany Report #JP_031002041 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Anxiety Professional (Olanapine) PS 290 MG/1 DAY Aspartate Company Wypax (Lorazepam) C Aminotransferase Representative Increased Other Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Potassium Increased Body Temperature Increased C-Reactive Protein Increased Chromaturia Coma Delusion Hepatic Function Abnormal Insomnia Intentional Misuse Po2 Increased Sputum Discoloured Suicidal Ideation 24-Jun-2005 12:19 PM Page: 2770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/04ISR Number: 4293881-6Report Type:Expedited (15-DaCompany Report #JP_031102150 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Other Cardiomegaly Health (Olanzapone) PS 5 MG/3 DAY Dizziness Professional Wypax (Lorazepam) C Dysphagia Company Benzalin Loss Of Consciousness Representative (Nitrazepam) C Myocardial Infarction Other Hirnamin Respiratory Arrest (Levomepromazine) C Silece (Flunitrazepam) C Eurodin (Estazolam) C Date:02/11/04ISR Number: 4293884-1Report Type:Expedited (15-DaCompany Report #JP_031102236 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) PS 10 MG/DAY Aspartate Professional Evamyl Aminotransferase Company (Lormetazepam) C Increased Representative Alosenn C Blood Chloride Decreased Other Magnesium Oxide C Blood Lactate Nitorol (Isosorbide Dehydrogenase Increased Dinitrate) C Blood Sodium Decreased Bayaspirin Bone Marrow Tumour Cell (Acetylsalicylic Infiltration Acid) C Cytomegalovirus Antibody Benzalin Positive (Nitrazepam) C Decreased Appetite Epstein-Barr Virus Antibody Positive Hepatic Function Abnormal Nasopharyngitis Pancytopenia Pyrexia Splenomegaly Date:02/11/04ISR Number: 4293984-6Report Type:Expedited (15-DaCompany Report #JP_031202320 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Zyprexa-Oral Hospitalization - Cardio-Respiratory Arrest Health (Olanzapine) Initial or Prolonged Drug Ineffective Professional (Olanzapine) PS 5 MG/DAY Other Hypertension Company Thyradin S Irritability Representative (Levothyroxine Logorrhoea Other Sodium) SS Malaise Lullan (Perospirone Treatment Noncompliance Hydrochloride) C Weight Increased Tasmolin (Biperiden) C Atarax-P (Hydroxyzine Hydrochloride) C Rohipnol (Flunitrazepam) C Benzalin 24-Jun-2005 12:19 PM Page: 2771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nitrazepam) C Pursennid (Senna Leaf) C Date:02/11/04ISR Number: 4293988-3Report Type:Expedited (15-DaCompany Report #JP_040102541 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Permax (Pergolide Health Mesylate) PS 2250 MCG/DAY Professional Zyprexa-Oral Company (Olanzapine) SS 15 MG/DAY Representative Menesit C Other Hicee (Ascorbic Acid) C Magnesium Oxide C Date:02/11/04ISR Number: 4294011-7Report Type:Expedited (15-DaCompany Report #JP_031202405 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa-Oral Completed Suicide Health (Olanzapine) Hepatic Function Abnormal Professional (Olanzapine) PS 15 MG/DAY Soliloquy Company Hirnamin Somnolence Representative (Levomepromazine) C Other Impromen (Bromperidol) C Mucosolvan (Ambroxol Hydrochloride) C Theodur (Theophylline) C Pakisonal (Trihexyphenidyl Hydrochloride) C Tasmolin (Biperiden) C Date:02/11/04ISR Number: 4294145-7Report Type:Expedited (15-DaCompany Report #USA031050668 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Health Zyprexa-Oral Pregnancy Professional (Olanzapine) Metrorrhagia (Olanzapine) PS 10 MG/ 2 IN THE MORNING Haldol (Haloperidol) C Date:02/11/04ISR Number: 4294146-9Report Type:Expedited (15-DaCompany Report #USA040157657 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intestinal Infarction Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 2772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/04ISR Number: 4294223-2Report Type:Expedited (15-DaCompany Report #EWC040137801 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Health (Olanzapine) PS 20 MG/DAY Aspartate Professional Depakine Chrono C Aminotransferase Other Efexor (Venlafaxine Increased Hydrochloride) C Blood Lactate Clotiapine C Dehydrogenase Increased Levothyroxine C Gamma-Glutamyltransferase Zocor (Simvastatin) C Increased Plavix (Clopidogrel Liver Disorder Sulfate) C Beloc Zok (Metoprolol Succinate) C Xanax (Alprazolam) C Antra Mups (Omeprazole Magnesium) C Date:02/11/04ISR Number: 4294225-6Report Type:Expedited (15-DaCompany Report #EWC040137771 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oral Initial or Prolonged Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Depakine (Valproate Sodium) C Psychopax (Diazepam) C Risperdal (Risperidone) C Date:02/11/04ISR Number: 4294227-XReport Type:Expedited (15-DaCompany Report #DE_040112879 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa-Oral Initial or Prolonged Liver Function Test Health (Olanzapine) Abnormal Professional (Olanzapine) PS 20 MG/DAY Loss Of Consciousness Other Solian (Amisulpride) C Rhabdomyolysis Ximovan (Zopiclone) C Tavor (Lorazepam) C Date:02/11/04ISR Number: 4294314-6Report Type:Expedited (15-DaCompany Report #USA040157695 Age: Gender:Female I/FU:I Outcome PT Chills Diarrhoea Drug Ineffective Dyspepsia Feeling Abnormal Flatulence Gastrointestinal Disorder Gingival Bleeding Gingival Pain 24-Jun-2005 12:19 PM Page: 2773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oral Intake Reduced Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG Date:02/11/04ISR Number: 4294316-XReport Type:Expedited (15-DaCompany Report #USA040157768 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa-Oral Initial or Prolonged Hallucination Professional (Olanzapine) Incontinence (Olanzapine) PS 10 MG/DAY 3 WK Medication Error Somnolence Vomiting Date:02/11/04ISR Number: 4294317-1Report Type:Expedited (15-DaCompany Report #USA040157786 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Cogentin (Benzatropine Mesilate) C Risperidone C Date:02/11/04ISR Number: 4294347-XReport Type:Expedited (15-DaCompany Report #USA040157906 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa-Oral Aggression (Olanzapine) Anger (Olanzapine) PS 15 MG/DAILY 15 MON Drug Effect Decreased Imipramine C Dyspnoea Clonidine C Dysuria Gastrointestinal Motility Disorder Hunger Hyperphagia Intentional Self-Injury Psychomotor Hyperactivity Weight Increased Date:02/11/04ISR Number: 4294349-3Report Type:Expedited (15-DaCompany Report #US_0401100309 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Double Ureter Health Zyprexa-Oral Maternal Drugs Affecting Professional (Olanzapine) Foetus (Olanzapine) PS 9 MON Buspar (Buspirone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft (Sertraline Hydrochloride) C Wellbutrin Sr (Bupropion Hydrochloride) C Multivitamins Nos C Folic Acid C Date:02/11/04ISR Number: 4294359-6Report Type:Expedited (15-DaCompany Report #US_030796404 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Study Zyprexa-Oral Life-Threatening Brain Oedema Health (Olanzapine) PS 15 MG/DAY Brain Scan Abnormal Professional Gemfibrozil C Cardiac Arrest Company Amlosipine Besilate C Coma Representative Hydrochlorothiazide C Diabetic Ketoacidosis Other Benzotropine Electrocardiogram Qt Besilate C Prolonged Electrocardiogram St Segment Abnormal Flatulence Gastrointestinal Oedema Hepatic Enzyme Increased Hyperglycaemia Hypokalaemia Hypotension Hypovolaemia Infection Intestinal Infarction Liver Disorder Multi-Organ Failure Pulse Absent Renal Failure Acute Respiratory Arrest Respiratory Failure Rhabdomyolysis Sinus Tachycardia Ventricular Fibrillation Date:02/11/04ISR Number: 4294434-6Report Type:Expedited (15-DaCompany Report #USA020921349 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Fluctuation Consumer Humulin-Human Nph Initial or Prolonged Cerebrovascular Accident Insulin (Rdna) Fall (Human Insulin (Rd PS Hip Fracture Humalog-. (Lispro) SS Irritability Iletin-Beef/Pork Triple Vessel Bypass Lente Insulin Graft (Insulin, Animal) SS 40 YR Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Zyprexa-Oral (Olanzapine) SS 10 MG/DAY Humulin-Human Lente 24-Jun-2005 12:19 PM Page: 2775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin (Rdna) (Human Insulin ( SS Lantus (Insulin Glargine) C Prevacid (Lansoprazole) C Ativan (Lorazepam) C Thyroid C Plavix (Clopidogrel Sulfate) C Date:02/11/04ISR Number: 4294436-XReport Type:Expedited (15-DaCompany Report #USA031050193 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Benadryl (Diphenhydramine Hydrochloride) C Date:02/11/04ISR Number: 4294472-3Report Type:Expedited (15-DaCompany Report #GBS040114345 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Health (Olanzapine) PS 10 MG Pco2 Decreased Professional Respiratory Failure Other Weight Increased Date:02/11/04ISR Number: 4294475-9Report Type:Expedited (15-DaCompany Report #FR_040103470 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa-Oral Initial or Prolonged Agitation Health (Olanzapine) Blood Uric Acid Increased Professional (Olanzapine) PS Coma Other Fluanxol Drug Toxicity (Flupentixol Haemodialysis Dihydrochloride) C Hepatic Failure Lepticur Miosis (Tropatepine Pneumonia Aspiration Hydrochloride) C Renal Failure Tranxene Renal Tubular Necrosis (Clorazepate Dipotassium) C Imovane (Zopiclone) C Subutex (Buprenorphine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/04ISR Number: 4294494-2Report Type:Expedited (15-DaCompany Report #US_030493865 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Zyprexa-Oral Health (Olanzapine) PS 30 MG/DAY Professional Benadryl Company (Diphenhydramine Representative Hydrochloride) C Lamictal (Lamotrigine) C Synthroid (Levothyroxine Sodium) C Avandia (Rosiglitazone Maleate) C Prevacid (Lansoprazole) C Atenolol C Claritin-D C Propanolol C Date:02/11/04ISR Number: 4294495-4Report Type:Expedited (15-DaCompany Report #US_031198655 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Alcohol Use Health Zyprexa-Oral Anomaly Of External Ear Professional (Olanzapine) PS Congenital Prozac-Oral Caesarean Section (Fluoxetine)(Fluoxet Facial Dysmorphism ine Hydrochloride) SS Foetal Alcohol Syndrome Klonopin Maternal Drugs Affecting (Clonazepam) C Foetus Ibuprofen C Microcephaly Acetaminophen C Paralysis Magnesium Hydroxide C Spine Malformation Aluminum/Magnesium/S imeth C Cetylpyridinium Chloride C Lopedium (Loperamide Hydrochloride) C Multivitamin C Date:02/11/04ISR Number: 4294504-2Report Type:Expedited (15-DaCompany Report #JP_040102551 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Infarction Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Zotepine C Representative Haloperidol C Other 24-Jun-2005 12:19 PM Page: 2777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/04ISR Number: 4294505-4Report Type:Expedited (15-DaCompany Report #GBS040114359 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Olanzapine-Oral Other Lymphocytic Leukaemia Health (Olanzapine) PS 75 MG/DAY Neutropenia Professional Aspirin C Other Paroxetine C Simvastatin C Zopiclone C Date:02/11/04ISR Number: 4294507-8Report Type:Expedited (15-DaCompany Report #DE_040112844 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Foreign Zyprexa-Oral Hospitalization - Alanine Aminotransferase Health (Olanzapine) Initial or Prolonged Increased Professional (Olanzapine) PS 5 MG/DAY Blood Alkaline Company Phosphatase Increased Representative Blood Bilirubin Increased Other Cholelithiasis Exanthem Hepatic Steatosis Hepatitis Toxic Date:02/11/04ISR Number: 4294509-1Report Type:Expedited (15-DaCompany Report #JP_040102574 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Literature (Olanzapine) Electrocardiogram Health (Olanzapine) PS 1O MG/DAY Abnormal Professional Electrocardiogram St Other Segment Abnormal Psychotic Disorder Tachycardia Date:02/11/04ISR Number: 4294513-3Report Type:Expedited (15-DaCompany Report #JP_040102562 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Asthma Literature (Olanzapine) Condition Aggravated Health (Olanzapine) PS 20 MG/DAY Delusion Of Reference Professional Quetiapine Fumarate C Depressed Mood Other Sulpiride C Diabetes Mellitus Valproate Sodium C Hallucination, Auditory Bromazepam C Persecutory Delusion Trihexyphenidyl Scar Hydrochloride C Vegetamin B C 24-Jun-2005 12:19 PM Page: 2778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/04ISR Number: 4294624-2Report Type:Expedited (15-DaCompany Report #JP_040102565 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zyprexa Oral Consciousness Study (Olanzapine) PS 5 MG DAY Fall Health Impromen Professional (Bromperidol) C Other Akineton (Biperiden Hydrochloride) C Doral (Quazepam) C Eurodin (Estazolam) C Depas (Etizolam) C Forsenid (Sennoside A+B) C Pantosin (Pantethine) C Magnesium Oxide Heavy C Date:02/11/04ISR Number: 4294632-1Report Type:Expedited (15-DaCompany Report #JP_040102488 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Zyprexa Oral Csf White Blood Cell Study (Olanzapine) PS 10 MG DAY Count Increased Health Rohypnol Face Oedema Professional (Flunitrazepam) C Hypothyroidism Other Fursennid (Senna Lymphocyte Count Leaf) C Decreased Mercazole Nasopharyngitis (Thiamazole) C Neutrophil Count Hirnamin Increased (Levomepromazine) C Sleep Apnoea Syndrome Isomytal Somnolence (Amobarbital) C Date:02/12/04ISR Number: 4296419-2Report Type:Expedited (15-DaCompany Report #2004-112592-NL Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Foreign Mirtazapine PS ORAL 30 MG 71 DAY Leukopenia Health Olanzapine SS ORAL DF 3 DAY Professional Other Date:02/17/04ISR Number: 4297169-9Report Type:Direct Company Report #CTU 56342 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa Zydis PS Lilly Date:02/17/04ISR Number: 4299152-6Report Type:Direct Company Report #CTU 212486 Age:21 YR Gender:Female I/FU:I Outcome PT Other Chest Discomfort Confusional State 24-Jun-2005 12:19 PM Page: 2779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Corneal Reflex Decreased Lethargy Movement Disorder Report Source Product Role Manufacturer Route Dose Duration Parkinsonian Rest Tremor Reglan 5mg PS ORAL 5 MG TID ORAL Parkinsonism Zyprexa 2.5 Mg SS ORAL 3.75MG Q HS Tongue Disorder ORAL Date:02/17/04ISR Number: 4299155-1Report Type:Expedited (15-DaCompany Report #MK200402-0102-1 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Anafranil 75mg Initial or Prolonged Alanine Aminotransferase Capsules 100 PS 1500MG, ONE Decreased TIME Blood Glucose Increased Zyprexa 10mg SS 200MG, ONE Confusional State TIME Haemoglobin Decreased Intentional Misuse Multiple Drug Overdose Somnolence Date:02/17/04ISR Number: 4299520-2Report Type:Direct Company Report #CTU 212407 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine PS Date:02/17/04ISR Number: 4300649-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201533 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Risperidone Cardiac Failure Acute Health (Risperidone) Coma Professional Unspecified PS ORAL 2 & 3 & 6 MG, Drug Interaction IN 1 DAY, Fall ORAL Hypersomnia Olanzapine Restlessness (Olanzapine) SS ORAL 2.5 MG, IN 1 Sudden Death DAY, ORAL Psychotropic Agents (Antipsychotics) SS ORAL 1IN 1 AS NECCESSARY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Bromazepam (Bromazepam) C Quazepam (Quazepam) C Triazolam (Triazolam) C Vegetamin (Vegetamin) C 24-Jun-2005 12:19 PM Page: 2780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4297446-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-358869 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Rivotril PS Roche ORAL 10 DAY Initial or Prolonged Increased Zyprexa SS ORAL 11 DAY Aspartate Tercian SS ORAL 5 DAY Aminotransferase Largactil SS ORAL 7 DAY Increased Blood Alkaline Phosphatase Increased Hepatitis Date:02/18/04ISR Number: 4300218-2Report Type:Direct Company Report #CTU 212548 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anion Gap Abnormal Zyprexa 15 Mg Lilly PS Lilly ORAL 15 MG PO Q Initial or Prolonged Blood Ketone Body Present DAY Diabetic Ketoacidosis Zoloft C Elavil C Date:02/18/04ISR Number: 4300243-1Report Type:Expedited (15-DaCompany Report #FR_040203543 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 1 DSG Other FORM/DAY Clamoxyl (Amoxicillin Trihydrate) C Lexomil (Bromazepam) C Theralene (Alimemazine Tartrate) C Tercian (Cyamemazine) C Artane (Trihexyphenidyl Hydrochloride) C Risperdal (Risperidone) C Seropram (Citalopram Hydrobromide) C Utrogestan (Progesterone) C Seglor (Dihydroergotamine Mesilate) C Imovane (Zopiclone) C Date:02/18/04ISR Number: 4300244-3Report Type:Expedited (15-DaCompany Report #EWC040237944 Age:67 YR Gender:Male I/FU:I Outcome PT Hospitalization - Hepatitis Cholestatic Initial or Prolonged Hyperthyroidism 24-Jun-2005 12:19 PM Page: 2781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 1 DSG Other FORM/DAY Tapazole (Thiamazole) C Pertiroid (Potassium Perchlorate) C Enapren (Enalapril Maleate) C Dilatrend (Carvedilol) C Date:02/18/04ISR Number: 4300245-5Report Type:Expedited (15-DaCompany Report #EWC040237879 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Olanzapine-Oral Initial or Prolonged Decreased Activity Health (Olanzapine) PS 5 MG/DAY Other Drug Interaction Professional Cipralex Exanthem Other (Escitalopram) C Fall Lamictal General Physical Health (Lamotrigine) C Deterioration Temesta (Lorazepam) C Haemothorax Infection Leukopenia Normochromic Normocytic Anaemia Oral Intake Reduced Pruritus Generalised Rib Fracture Urinary Tract Infection Date:02/18/04ISR Number: 4300247-9Report Type:Expedited (15-DaCompany Report #JP_031002041 Age:43 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Other Aspartate Aminotransferase Increased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Potassium Increased Body Temperature Increased C-Reactive Protein Increased Chromaturia Coma Family Stress Hepatic Function Abnormal Insomnia 24-Jun-2005 12:19 PM Page: 2782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Misuse Po2 Increased Restlessness Report Source Product Role Manufacturer Route Dose Duration Somnolence Foreign Zyprexa-Oral Sputum Discoloured Health (Olanzapine) Suicide Attempt Professional (Olanzapine) PS 290 MG/1 DAY Treatment Noncompliance Company Representative Other Date:02/18/04ISR Number: 4300249-2Report Type:Expedited (15-DaCompany Report #JP_030901706 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Aspartate Professional (Olanzapine) PS 15 MG/DAY Aminotransferase Company Tegretol Increased Representative (Carbamazepine) C Blood Creatine Other Doral (Quazepam) C Phosphokinase Increased Sennoside A+B C Chromaturia Silece Dizziness (Flunitrazepam) C Hyponatraemia Magnesium Oxide C Malaise Muscular Weakness Myalgia Polydipsia Polyuria Pyrexia Rectal Prolapse Rhabdomyolysis Date:02/18/04ISR Number: 4300251-0Report Type:Expedited (15-DaCompany Report #GBS030413027 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Atherosclerosis Foreign Zyprexa-Oral Cardiac Arrest Consumer (Olanzapine) Completed Suicide Health (Olanzapine) PS Coronary Artery Professional Zopiclone C Atherosclerosis Company Temazepam C Cyclothymic Disorder Representative Lamotrigine C Drug Toxicity Other Haemoglobin Increased Infection Lymphocyte Count Increased Monocyte Count Increased Multiple Drug Overdose Nephrosclerosis Neutrophil Count Increased Platelet Count Increased Red Blood Cell Count Increased White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4300252-2Report Type:Expedited (15-DaCompany Report #CA_020905342 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombophlebitis Foreign Zyprexa-Oral Other Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG DAY Other Date:02/18/04ISR Number: 4300308-4Report Type:Expedited (15-DaCompany Report #US_0402100426 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Consumer Zyprexa Oral (Olanzapine) (Olanzapine) PS Benztropine C Paroxetine C Date:02/18/04ISR Number: 4300336-9Report Type:Expedited (15-DaCompany Report #2004009393 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zoloft (Sertraline) PS ORAL 100 MG DAILY Initial or Prolonged Aminotransferase Health ORAL Increased Professional Olanzapine Blood Creatine (Olanzapine) SS ORAL 5 MG ORAL Phosphokinase Increased Madopar (Levodopa, Blood Creatine Benserazide Phosphokinase Mb Hydrochloride) C Increased Zolpidem Tartrate C Fall Omeprazole Magnesium C General Physical Health Sorbinil C Deterioration Injury Rhabdomyolysis Date:02/18/04ISR Number: 4300342-4Report Type:Expedited (15-DaCompany Report #2003035058 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Blood Glucose Increased Disability Chills Other Decreased Appetite Depression Drug Interaction Herpes Virus Infection Hypersensitivity Insomnia Leukocytoclastic Vasculitis Malaise Nasal Congestion Oral Candidiasis Oropharyngeal Swelling Otorrhoea Pharyngolaryngeal Pain Photosensitivity Reaction 24-Jun-2005 12:19 PM Page: 2784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Psychosomatic Disease Rhinitis Allergic Report Source Product Role Manufacturer Route Dose Duration Skin Burning Sensation Consumer Zithromax Skin Tightness (Caps) Stevens-Johnson Syndrome (Azithromycin) PS ORAL DAILY, ORAL Swollen Tongue Carbamazepine Tension Headache (Carmazepine) SS ORAL ORAL Tinea Cruris Olanzapine Toxic Epidermal (Olanzapine) SS ORAL ORAL Necrolysis Venlafaxine Upper Gastrointestinal Hydrochloride Haemorrhage (Venlafaxine Vision Blurred Hydrochloride) C Weight Decreased Date:02/18/04ISR Number: 4300415-6Report Type:Expedited (15-DaCompany Report #JP_040202614 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Foreign Zyprexa-Oral Initial or Prolonged Dementia Literature (Olanzapine) Depressed Level Of Health (Olanzapine) PS 7.5 MG/DAY Consciousness Professional Donepezil Excitability Other Hydrochloride C Muscle Rigidity Trihexyphenidyl C Physical Examination Abnormal Restlessness Tremor Date:02/18/04ISR Number: 4300420-XReport Type:Expedited (15-DaCompany Report #US_0402100495 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) Dyskinesia Professional (Olanzapine) PS Dysphasia Other Risperdal Haemorrhage (Risperidone) C Hyperhidrosis Hyperthermia Mallory-Weiss Syndrome Muscle Rigidity Neuroleptic Malignant Syndrome Salivary Hypersecretion Somnolence Tachycardia Tachypnoea Tremor Urinary Retention Vomiting 24-Jun-2005 12:19 PM Page: 2785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4300562-9Report Type:Expedited (15-DaCompany Report #USA031254272 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Caesarean Section Health Zyprexa-Oral Congenital Anomaly Hypertelorism Of Orbit Professional (Olanzapine) PS Intra-Uterine Death Company Ativan (Lorazepam) C Maternal Drugs Affecting Representative Prenatal Vitamins C Foetus Nicorette Gum Placental Insufficiency (Nicotine Resin) C Umbilical Cord Ensure C Abnormality Colace (Docusate Sodium) C Neurontin (Gabapentin) C Seroquel (Quetiapine Fumarate) C Date:02/18/04ISR Number: 4300669-6Report Type:Expedited (15-DaCompany Report #JP_040202607 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG/DAY Company Risperdal Representative (Risperidone) C Other Vegetamin A C Lexotan (Bromazepam) C Doral (Quazepam) C Date:02/18/04ISR Number: 4300673-8Report Type:Expedited (15-DaCompany Report #JP_040102488 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Increased Study (Olanzapine) Blood Alkaline Health (Olanzapine) PS ORAL 10 MG/DAY Phosphatase Increased Professional Rohypnol Bronchitis Other (Flunitrazepam) C Eosinophil Count Pursennid (Senna Increased Leaf) C Face Oedema Mercazole Gamma-Glutamyltransferase (Thiamazole) C Increased Hirnamin Haemoglobin Decreased (Levomepromazine) C Hypothyroidism Isomytal(Amobarbital Lymphocyte Count ) C Decreased Neutrophil Count Increased Red Blood Cell Count Decreased Sleep Apnoea Syndrome Somnolence 24-Jun-2005 12:19 PM Page: 2786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4300674-XReport Type:Expedited (15-DaCompany Report #JP_040202585 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Smoker Foreign Zyprexa-Oral Subarachnoid Haemorrhage Study (Olanzapine) Health (Olanzapine) PS 10 MG/1 DAY Professional Magnesium Oxide C Other Akineton (Biperiden Hydrochloride) C Serenace (Haloperidol) C Pursennide (Senna Leaf) C Lexotan (Bromazepam) C Lasix (Furosemide) C Artane (Trihexyphenidyl Hydrochloride) C Vegetamin B C Alosenn C Date:02/18/04ISR Number: 4300677-5Report Type:Expedited (15-DaCompany Report #GBS040214375 Age:70 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Olanzapine-Oral Sudden Death Health (Olanzapine) PS 2.5 MG/DAY Professional Other Date:02/18/04ISR Number: 4300680-5Report Type:Expedited (15-DaCompany Report #FR_040203526 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/DAY Company Representative Other Date:02/18/04ISR Number: 4300707-0Report Type:Expedited (15-DaCompany Report #US_0402100370 Age:22 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Acute Psychosis Caesarean Section Complications Of Maternal Exposure To Therapeutic Drugs Hypertelorism Of Orbit Intra-Uterine Death Maternal Drugs Affecting Foetus Placental Insufficiency Smear Cervix Abnormal Trisomy 21 24-Jun-2005 12:19 PM Page: 2787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Umbilical Cord Short Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 20 MG/ 1 AT Professional BEDTIME Company Ativan (Lorazepam) C Representative Prenatal Vitamins C Nicorette Gum (Nicotine Resin) C Ensure C Colace (Docusate Sodium) C Neurontin (Gabapentin) C Seroquel (Quetiapine Fumarate) C Date:02/18/04ISR Number: 4300710-0Report Type:Expedited (15-DaCompany Report #USA040258187 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pleural Effusion Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:02/18/04ISR Number: 4300712-4Report Type:Expedited (15-DaCompany Report #USA040258152 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Consumer Zyprexa-Oral Somnolence (Olanzapine) (Olanzapine) PS 10 MG/ IN THE EVENING Zoloft (Sertraline Hydrochloride) C Date:02/20/04ISR Number: 4302020-4Report Type:Expedited (15-DaCompany Report #EWC040137801 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine- Oral Initial or Prolonged Increased Health (Olanzapine) PS ORAL 20 MG DAY Aspartate Professional Depakine Chrono C Aminotransferase Other Effexor (Venlafaxine Increased Hydrochloride) C Blood Lactate Clotiapine C Dehydrogenase Increased Levothyroxine C Gamma-Glutamyltransferase Zocor (Simvastatin) C Increased Plavix (Clopidogrel Liver Disorder Sulfate) C Liver Function Test Beloc Zok Abnormal (Metoprolol Succinate) C Xanax (Alprazolam) C Antra Mups (Omeprazole Magnesium) C 24-Jun-2005 12:19 PM Page: 2788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/04ISR Number: 4302024-1Report Type:Expedited (15-DaCompany Report #JP_031202380 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Zyprexa-Oral Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS 25 MG DAY Blood Creatinine Company Risperdal Increased Representative (Risperidone) C Blood Gases Abnormal Other Serenace Blood Pressure Decreased (Haloperidol) C Blood Urea Increased Contomin Body Temperature (Chlorpromazine Increased Hydrochloride) C Cardio-Respiratory Arrest Akineton (Biperiden Dehydration Hydrochloride) C Depressed Level Of Rohypnol Consciousness (Flunitrazepam) C Diabetic Ketoacidosis Vegetamin B C Fall Feeling Abnormal Haemodialysis Hyperhidrosis Hypoxia Metabolic Acidosis Neuroleptic Malignant Syndrome Platelet Count Decreased Pyrexia Tachycardia White Blood Cell Count Increased Date:02/23/04ISR Number: 4303232-6Report Type:Expedited (15-DaCompany Report #DSA_23976_2004 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Tavor PS ORAL 20 MG ONCE PO Initial or Prolonged Hypertension Health Citalopram SS ORAL 1200 MG ONCE Intentional Misuse Professional PO Multiple Drug Overdose Other Zyperxa SS ORAL 390 MG ONCE Somnolence PO Tachycardia Vomiting Date:02/23/04ISR Number: 4303479-9Report Type:Expedited (15-DaCompany Report #2004007836 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Geodon (Ziprasidone) PS Cardiac Disorder Professional Olazapine Pulmonary Thrombosis Company (Olanzapine) SS Representative 24-Jun-2005 12:19 PM Page: 2789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/04ISR Number: 4303577-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Risperidone Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Ziprasidone (Ziprasidone) SS ORAL ORAL Perphenazine (Perphenazine) SS ORAL ORAL Lorazepam (Lorazepam) C Date:02/24/04ISR Number: 4303799-8Report Type:Direct Company Report #CTU 212988 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crystal Urine Present Zyprexa 5 Mg Eli Initial or Prolonged Dehydration Lilly PS Eli Lilly 5 MG 1 A DAY Feeling Abnormal Nausea Oral Intake Reduced Tremor Vomiting Date:02/24/04ISR Number: 4304585-5Report Type:Expedited (15-DaCompany Report #S04-SWI-00443-01 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Cipralex Initial or Prolonged Aminotransferase Health (Escitalopram) PS ORAL 5 MG QD PO Increased Professional Cipralex(Escitalopra Depressed Level Of Other m) SS ORAL 10 MG QD PO Consciousness Cipralex(Escitalopra Dermatitis Allergic m) SS ORAL 10 MG QD PO Difficulty In Walking Cipralex(Escitalopra Fall m) SS ORAL 15 MG QD PO Haemothorax Lamictal "Burroughs Leukopenia Wellcome"(Lamotrigin Pruritus e) SS ORAL 100 MG QD PO Rib Fracture Lamictal "Burroughs Urinary Tract Infection Wellcome"(Lamotrigin e) SS Zyprexa (Olanzapine) SS ORAL 2.5 MG QD PO Zyprexa (Olanzapine) SS ORAL 5 MG QD PO Remeron C Temesta C Date:02/25/04ISR Number: 4304458-8Report Type:Direct Company Report #CTU 213146 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Dyspnoea Olanzapine PS ORAL 5 MG ORAL Fall Muscle Rigidity Neuroleptic Malignant Syndrome Date:02/25/04ISR Number: 4306006-5Report Type:Expedited (15-DaCompany Report #USA011210290 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Consumer Prozac-Oral Initial or Prolonged Back Pain (Fluoxetine) Cardiomegaly (Fluoxetine Dizziness Postural Hydrochloride) PS 20 MG/DAY Eye Swelling Zyprexa-Oral Neck Pain (Olanzapine) Pain (Olanzapine) SS 5 MG/DAY Psoriasis Ibrium Somnolence (Chlordiazepoxide Hydrochloride) C Norvasc (Amlodipine Besilate) C Bextra (Valdecoxib) C Date:02/25/04ISR Number: 4306829-2Report Type:Expedited (15-DaCompany Report #FR_040203580 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa-Oral Initial or Prolonged Fall Health (Olanzapine) Femur Fracture Professional (Olanzapine) PS 10 MG/DAY Prothrombin Time Other Depakine (Valproate Prolonged Sodium) C Valium (Diazepam) C Date:02/25/04ISR Number: 4306830-9Report Type:Expedited (15-DaCompany Report #GBS040214414 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG Other Professional Venlafaxine C Other Date:02/25/04ISR Number: 4306831-0Report Type:Expedited (15-DaCompany Report #GBS040214423 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Oral Pulmonary Oedema Health (Olanzapine) Sudden Death Professional (Olanzapine) PS Company Representative Other 24-Jun-2005 12:19 PM Page: 2791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4306832-2Report Type:Expedited (15-DaCompany Report #FR_040203576 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Foreign Zyprexa-Oral Haemorrhage Study (Olanzapine) Health (Olanzapine) PS 10 MG/DAY Professional Other Date:02/25/04ISR Number: 4306833-4Report Type:Expedited (15-DaCompany Report #US_0402100693 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY 4 DAY Company Representative Other Date:02/25/04ISR Number: 4306847-4Report Type:Expedited (15-DaCompany Report #GBS040214413 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Olanzapine-Oral Corrected Interval Literature (Olanzapine) PS 30 MG/DAY Prolonged Health Clopixol Supraventricular Professional (Zuclopenthixol Extrasystoles Other Decanoate) C Clonazepam C Haloperidol C Amisulpride C Procyclidine C Valproate Sodium C Lorazepam C Date:02/25/04ISR Number: 4306849-8Report Type:Expedited (15-DaCompany Report #JP_040202632 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Zyprexa-Oral Initial or Prolonged Thyroid Gland Cancer Study (Olanzapine) Tumour Haemorrhage Health (Olanzapine) PS 5 MG/DAY Professional Neuleptil Other (Periciazine) C Risperdal (Risperidone) C Akineton (Biperiden Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Sennoside A C Chinese Medicine C Cetilo C 24-Jun-2005 12:19 PM Page: 2792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4306850-4Report Type:Expedited (15-DaCompany Report #EWC031137092 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Syndrome Foreign Zyprexa-Oral Initial or Prolonged Generalised Oedema Health (Olanzapine) Neurotoxicity Professional (Olanzapine) PS 2 DAY Therapeutic Agent Other Lithium Carbonate C Toxicity Date:02/25/04ISR Number: 4306851-6Report Type:Expedited (15-DaCompany Report #EWC040237964 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa-Oral Initial or Prolonged Injury Health (Olanzapine) Parkinson'S Disease Professional (Olanzapine) PS 5 MG/DAY Rhabdomyolysis Other Zoloft (Sertraline Hydrochloride) C Madopar C Stilnoct (Zolpidem Tartrate) C Losec (Omeprazole) C Sobril (Oxazepam) C Date:02/25/04ISR Number: 4306853-XReport Type:Expedited (15-DaCompany Report #EWC040238042 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysuria Foreign Olanzapine-Oral Initial or Prolonged Glomerular Filtration Health (Olanzapine) PS 20 MG/DAY Rate Decreased Professional Leponex (Clozapine) C Nephropathy Toxic Other Prothazin Polydipsia (Promethazine Polyuria Hydrochloride) C Renal Impairment Akineton (Biperiden Renal Tubular Disorder Hydrochloride) C Treatment Noncompliance Lokren (Betaxolol Urinary Tract Infection Hydrochloride) C Date:02/25/04ISR Number: 4306854-1Report Type:Expedited (15-DaCompany Report #FR_040203566 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Zyprexa-Oral Initial or Prolonged Neonatal Health (Olanzapine) Maternal Drugs Affecting Professional (Olanzapine) PS Foetus Other Tranxene (Clorazepate Dipotassium) C Date:02/25/04ISR Number: 4306855-3Report Type:Expedited (15-DaCompany Report #FR_040203579 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Colitis Ischaemic Foreign Initial or Prolonged Health Professional 24-Jun-2005 12:19 PM Page: 2793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 15 MG/DAY Lithium C Tercian (Cyamemazine) C Date:02/25/04ISR Number: 4306955-8Report Type:Expedited (15-DaCompany Report #JP_031202417 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delusion Foreign Zyprexa-Oral Hospitalization - Depressed Level Of Study (Olanzapine) Initial or Prolonged Consciousness Health (Olanzapine) PS 5 MG/DAY Dizziness Professional Vegetamin A C Hallucination, Auditory Other Vegetamin B C Insomnia Tinelac (Sennoside Pneumonia A+B) C Somnolence Uniphyl(Theophylline Stupor ) C Suicide Attempt Alosenn C Ruefrien C Rohypnol(Flunitrazep am) C Tasmolin(Biperiden) C Depas (Etizolam) C Brotizolam C Emilace (Nemonapride) C Zotepine C Date:02/25/04ISR Number: 4306959-5Report Type:Expedited (15-DaCompany Report #JP_040102515 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Mental Disorder Health (Olanzapine) Professional (Olanzapine) PS Company Depakene (Valproate Representative Sodium) C Other Date:02/25/04ISR Number: 4306962-5Report Type:Expedited (15-DaCompany Report #JP_040202607 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Foreign Zyprexa-Oral Increased Health (Olanzapine) Blood Glucose Increased Professional (Olanzapine) PS 2.5 MG/DAY Haemoglobin Decreased Company Risperdal Hypersomnia Representative (Risperidone) C Multiple Drug Overdose Other Vegetamin A C Sudden Death Lexotan (Bromazepam) C Thyroxine Free Decreased Doral (Quazepam) C 24-Jun-2005 12:19 PM Page: 2794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4306965-0Report Type:Expedited (15-DaCompany Report #US_0402100495 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Foreign Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Health (Olanzapine) Syndrome Professional (Olanzapine) PS Oesophageal Rupture Other Risperdal Vomiting (Risperidone) C Pimozide C Date:02/25/04ISR Number: 4306968-6Report Type:Expedited (15-DaCompany Report #JP_030801654 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa-Oral Initial or Prolonged Depressed Level Of Study (Olanzapine) Consciousness Health (Olanzapine) PS 10 MG/DAY Hypochloraemia Professional Lullan (Perospirone Hyponatraemia Other Hydrochloride) C Depas (Etizolam) C Setous (Zotepine) C Benzalin (Nitrazepam) C Isomytal (Amobarbital) C Brovarin (Bromisoval) C Picoben (Sodium Picosulfate) C Date:02/25/04ISR Number: 4307112-1Report Type:Expedited (15-DaCompany Report #USA040258717 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other (Olanzapine) PS 20 MG/DAY Date:02/25/04ISR Number: 4307113-3Report Type:Expedited (15-DaCompany Report #US_0402100550 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Zyprexa-Oral Overdose (Olanzapine) (Olanzapine) PS Date:02/25/04ISR Number: 4307115-7Report Type:Expedited (15-DaCompany Report #USA040258922 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Zyprexa-Oral Initial or Prolonged Exposure To Therapeutic Professional (Olanzapine) Drugs (Olanzapine) PS Hospitalisation Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4307177-7Report Type:Expedited (15-DaCompany Report #USA040157768 Age:5 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa-Oral Initial or Prolonged Hallucination Professional (Olanzapine) Incontinence (Olanzapine) PS 10 MG/DAY 3 WK Medication Error Somnolence Vomiting Date:02/26/04ISR Number: 4305475-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12336426 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Effect Health Abilify Tabs 10 Mg PS Otsuka Overdose Professional Pharmaceutical Company, Ltd. ORAL Effexor Xr SS ORAL Zyprexa SS ORAL Date:02/26/04ISR Number: 4307056-5Report Type:Direct Company Report #CTU 213281 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Zyprexa (Lilly) PS Lilly ORAL 25 MG PO HS Initial or Prolonged Increased Fluphenazine C Blood Glucose Increased Fluphenazine Blood Triglycerides Decanoate C Increased Lithium C Polydipsia Lisinopril C Polyuria Vitamins C Aspirin C Date:02/27/04ISR Number: 4306914-5Report Type:Direct Company Report #CTU 213309 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Olanzapine PS ORAL 5 MG PO BID Increased Guanfacine C Blood Glucose Increased Clonidine C Sertraline C Loratadine C Date:02/27/04ISR Number: 4307713-0Report Type:Direct Company Report #CTU 213390 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Zyprexa PS Eli Lily Hospitalization - Extrapyramidal Disorder Initial or Prolonged Incoherent Joint Hyperextension Muscle Rigidity Tremor 24-Jun-2005 12:19 PM Page: 2796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/04ISR Number: 4308741-1Report Type:Expedited (15-DaCompany Report #2004-113130-NL Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petit Mal Epilepsy Health Remeron PS Simple Partial Seizures Professional Zyprexa SS Adderall C Date:02/27/04ISR Number: 4308837-4Report Type:Expedited (15-DaCompany Report #DSA_24006_2004 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Temesta PS Initial or Prolonged Bedridden Health Temesta SS ORAL 3 MG PO Decreased Activity Professional Temesta SS ORAL 1 MG PO Drug Interaction Other Temesta SS ORAL 1.5 MG PO Drug Level Increased Temesta SS ORAL 0.5 MG Q DAY Exanthem PO Fall Cipralex SS Haemothorax Cipralex SS Leukopenia Cipralex SS Normochromic Normocytic Lamictal SS 100 MG Q DAY Anaemia Lamictal SS Oral Intake Reduced Zyprexa SS 5 MG Q DAY Pruritus Zyprexa SS 2.5 MG Q DAY Rib Fracture Remeron SS Sedation Orfiril C Date:02/27/04ISR Number: 4309194-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201533 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Risperidone Asthenia Health (Risperidone) PS ORAL SEE IMAGE, Cardiac Arrest Professional ORAL Cardiac Failure Acute Olanzapine Coma (Olanzapine) SS ORAL 2.5 MG, IN 1 Delusion DAY, ORAL Drug Interaction Psychotropic Agents Fall (Antipsychotics) SS ORAL ORAL Fatigue Trihexyphenidyl Fear Hydrochloride Feeling Cold (Trihexyphenidyl Hypersomnia Hydrochloride) C Incoherent Biperiden Mydriasis Hydrochloride Respiratory Arrest (Biperiden Restlessness Hydrochloride) C Sudden Death Bromazepam Thought Blocking (Bromazepam) C Urinary Incontinence Quazepam (Quazepam) C Triazolam (Triazolam) C Vegetamin (Vegetamin) C 24-Jun-2005 12:19 PM Page: 2797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/04ISR Number: 4308802-7Report Type:Direct Company Report #CTU 213426 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Depakote 28:12 PS Initial or Prolonged Suicidal Ideation Zyprexa 28:16 SS Date:03/02/04ISR Number: 4310984-8Report Type:Direct Company Report #CTU 213552 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Effexor Xr PS PROVIDED IN Required Drug Dependence Zyprexa SS PROVED IN Intervention to Infection Hydrocodone SS Prevent Permanent Mental Disorder Neurontin SS Impairment/Damage Pain Ambien SS Oxycontin SS Oxycodone/Apap C Duragesic C Date:03/02/04ISR Number: 4311370-7Report Type:Direct Company Report #CTU 213545 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Olanzapine 5 Mg PS Initial or Prolonged Self-Medication Disability Required Intervention to Prevent Permanent Impairment/Damage Date:03/03/04ISR Number: 4311575-5Report Type:Direct Company Report #CTU 213680 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Olanzapine 25 Mg Lilly PS Lilly ORAL ORAL/HS Date:03/03/04ISR Number: 4311939-XReport Type:Expedited (15-DaCompany Report #ZA-JNJFOC-20031202196 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenopia Foreign Risperdal Astigmatism Health (Risperidone) Colour Blindness Professional Unspecified PS ORAL ORAL Diplopia Olanzapine Drug Interaction (Olanzapine) SS ORAL 15 MG, 1 IN 1 Vision Blurred DAY ORAL Visual Disturbance Lamotrigine C Date:03/04/04ISR Number: 4313076-7Report Type:Expedited (15-DaCompany Report #JP_040202641 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Death Cerebral Haemorrhage Foreign Health 24-Jun-2005 12:19 PM Page: 2798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Product Role Manufacturer Route Dose Duration Zyprexa Oral (Olanzapine) (Olanzapine) PS 20 MG/DAY Mercazole (Thiamazole) C Thyradin S (Levothyroxine Sodium) C Date:03/04/04ISR Number: 4313079-2Report Type:Expedited (15-DaCompany Report #DE_040213027 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Reticulocyte Count Health (Olanzapine) Increased Professional (Olanzapine) PS 5 MG/DAY White Blood Cell Count Company Multibionta C Decreased Representative Clexane Other (Heparin-Fraction, Sodium Salt) C Fortinel C Date:03/04/04ISR Number: 4313081-0Report Type:Expedited (15-DaCompany Report #EWC040238032 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Olanzapine-Oral First Degree Health (Olanzapine) PS 20 MG/IN THE Professional EVENING Company Representative Other Date:03/04/04ISR Number: 4313084-6Report Type:Expedited (15-DaCompany Report #AU_040207475 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Other Date:03/04/04ISR Number: 4313104-9Report Type:Expedited (15-DaCompany Report #JP_040202648 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Encephalopathy Foreign Zyprexa-Oral Hepatitis Fulminant Health (Olanzapine) Infection Professional (Olanzapine) PS 10 MG/DAY Prothrombin Time Company Tegretol Shortened Representative (Carbamazepine) C Other Depas (Etizolam) C Benzalin (Nitrazepam) C 24-Jun-2005 12:19 PM Page: 2799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/04ISR Number: 4313123-2Report Type:Expedited (15-DaCompany Report #JP_040102574 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Electrocardiogram Literature (Olanzapine) Abnormal Health (Olanzapine) PS 10 MG/DAY Electrocardiogram St Professional Linton (Haloperidol) C Segment Abnormal Company Clofekton Psychotic Disorder Representative (Clocapramine Tachycardia Other Hydrochloride) C Lodopin (Zotepine) C Impromen (Bromperidol) C Lullan (Perospirone Hydrochloride) C Bicamol (Biperiden Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Landsen (Clonazepam) C Date:03/04/04ISR Number: 4313128-1Report Type:Expedited (15-DaCompany Report #EWC011028613 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Olanzapine-Oral Blood Cholesterol Literature (Olanzapine) PS 5 MG/DAY Increased Health Lithium C Blood Glucose Increased Professional Valproate Sodium C Blood Triglycerides Company Lorazepam C Increased Representative Propanolol C Electrocardiogram Qt Other Corrected Interval Prolonged Grandiosity High Density Lipoprotein Decreased Persecutory Delusion Urine Analysis Abnormal White Blood Cells Urine Positive Date:03/04/04ISR Number: 4313176-1Report Type:Expedited (15-DaCompany Report #GBS040214409 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Abnormal Foreign Prozac-Oral Diabetic Ketoacidosis Health (Fluoxetine) Professional (Fluoxetine Company Hydrochloride) PS 20 MG Representative Olanzapine-Oral Other (Olanzapine) SS 10 MG 24-Jun-2005 12:19 PM Page: 2800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/04ISR Number: 4313419-4Report Type:Expedited (15-DaCompany Report #US_0402100838 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Swelling Face Health Zyprexa-Oral Tongue Disorder Professional (Olanzapine) Tracheal Obstruction (Olanzapine) PS 2.5 MG Klonopin (Clonazepam) C Date:03/04/04ISR Number: 4313423-6Report Type:Expedited (15-DaCompany Report #USA040259632 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa Professional (Olanzapine) PS ORAL 15 MG/DAY Cephalexin C Date:03/04/04ISR Number: 4313426-1Report Type:Expedited (15-DaCompany Report #USA040259560 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/04/04ISR Number: 4313550-3Report Type:Expedited (15-DaCompany Report #FR_030602559 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zyprexa-Oral Initial or Prolonged International Normalised Health (Olanzapine) Ratio Decreased Professional (Olanzapine) PS 15 MG/DAY Leukopenia Other Levothyrox Neutropenia (Levothyroxine Phlebitis Sodium) C Aspegic (Acetylsalicylate Lysine) C Mopral (Omeprazole) C Transipeg (Macrogol) C Fraxodi (Nadroparin Calcium) C Previscan (Fluindione) C Date:03/04/04ISR Number: 4313553-9Report Type:Expedited (15-DaCompany Report #FR_040103431 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholestasis Foreign Zyprexa-Oral Fungal Oesophagitis Health (Olanzapine) Oral Fungal Infection Professional (Olanzapine) PS 40 MG/DAY Prothrombin Time Other Largactil Prolonged (Chlorpromazine Hydrochloride) C Rivotril (Clonazepam) C 24-Jun-2005 12:19 PM Page: 2801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tercian (Cyamemazine) C Teralithe (Lithium Carbonate) C Date:03/04/04ISR Number: 4313556-4Report Type:Expedited (15-DaCompany Report #FR_040203576 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Foreign Zyprexa-Oral Haemorrhage Study (Olanzapine) Health (Olanzapine) PS 10 MG/DAY Professional Other Date:03/04/04ISR Number: 4313559-XReport Type:Expedited (15-DaCompany Report #EWC040137766 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Olanzapine-Oral Hospitalization - Muscle Rigidity Health (Olanzapine) PS 5 MG/DAY 1 WK Initial or Prolonged Pulmonary Embolism Professional Depakine (Valproate Respiratory Arrest Company Sodium) C Representative Tranxene Other (Clorazepate Dipotassium) C Gabapentin C Date:03/04/04ISR Number: 4313561-8Report Type:Expedited (15-DaCompany Report #EWC040238042 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Olanzapine-Oral Initial or Prolonged Glomerular Filtration Health (Olanzapine) PS 20 MG/DAY Other Rate Decreased Professional Leponex (Clozapine) C Nephropathy Toxic Other Prothazin Renal Tubular Disorder (Promethazine Schizophrenia, Hydrochloride) C Disorganised Type Akineton (Biperiden Treatment Noncompliance Hydrochloride) C Urinary Tract Infection Lokren (Betaxolol Hydrochloride) C Concor (Bisoprolol Fumarate) C Date:03/04/04ISR Number: 4313563-1Report Type:Expedited (15-DaCompany Report #FR_040203526 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa-Oral Health (Olanzapine)(Olanzap Professional ine) PS 20 MG/DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 2802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/04ISR Number: 4313574-6Report Type:Expedited (15-DaCompany Report #USA040259216 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Prozac-Oral Hospitalization - Weight Increased Professional (Fluoxetine) Initial or Prolonged Company (Fluoxetine Representative Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Seroquel (Quetiapine Fumarate) C Date:03/04/04ISR Number: 4313576-XReport Type:Expedited (15-DaCompany Report #USA021022950 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Pancreatitis Professional (Olanzapine) (Olanzapine) PS 225 MG/DAY Flexeril (Cyclobenzaprine Hydrochloride) C Xanax (Alprazolam) C Effexor (Venlafaxine Hydrochloride) C Date:03/05/04ISR Number: 4373881-8Report Type:Periodic Company Report #2004UW00951 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urine Odour Abnormal Consumer Crestor PS ORAL 10 MG PO Effexor SS Zyprexa SS Date:03/09/04ISR Number: 4314958-2Report Type:Expedited (15-DaCompany Report #GBS040214484 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inappropriate Foreign Olanzapine-Oral Initial or Prolonged Antidiuretic Hormone Health (Olanzapine) PS 20 MG Secretion Professional Other Date:03/09/04ISR Number: 4314960-0Report Type:Expedited (15-DaCompany Report #GBS040214513 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Impairment Foreign Zyprexa-Oral Sudden Death Health (Olanzapine) Therapeutic Agent Professional (Olanzapine) PS 10 MG/2 DAY Toxicity Other Lithium Carbonate C Urinary Tract Infection Haloperidol C Procyclidine C Clonazepam C 24-Jun-2005 12:19 PM Page: 2803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/04ISR Number: 4314963-6Report Type:Expedited (15-DaCompany Report #US_0402100838 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 2.5 MG Klonopin (Clonazepam) C Date:03/09/04ISR Number: 4314970-3Report Type:Expedited (15-DaCompany Report #AU_040307509 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Foreign Zyprexa-Oral Initial or Prolonged Electrocardiogram Qt Health (Olanzapine) Prolonged Professional (Olanzapine) PS 10 MG DAY Infarction Other Ventricular Tachycardia Date:03/09/04ISR Number: 4315039-4Report Type:Expedited (15-DaCompany Report #JP_040202677 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Hepatic Function Abnormal Professional (Olanzapine) PS Influenza Company Serenace Representative (Haloperidol) C Other Ciproxan (Ciprofloxacin Hydrochloride) C Date:03/09/04ISR Number: 4315041-2Report Type:Expedited (15-DaCompany Report #DE_040213066 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Increased Foreign Zyprexa-Oral Blood Sodium Increased Health (Olanzapine) Prescribed Overdose Professional (Olanzapine) PS 30 MG/DAY Other Date:03/09/04ISR Number: 4315044-8Report Type:Expedited (15-DaCompany Report #EWC031237486 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Disorder Male Foreign Zyprexa-Oral Hospitalization - Breast Engorgement Health (Olanzapine) Initial or Prolonged Thyrotoxic Crisis Professional (Olanzapine) PS 15 MG/DAY Company Anafranil Representative (Clomipramine Other Hydrochloride) C Rivotril (Clonazepam) C Ergotop (Nicergoline) C Lescol (Fluvastatin Sodium) C 24-Jun-2005 12:19 PM Page: 2804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ticlid (Ticlopidine Hydrochloride) C Metothyrin (Thiamazole) C Betaloc (Metoprolol Tartrate) C Date:03/09/04ISR Number: 4315048-5Report Type:Expedited (15-DaCompany Report #JP_040202673 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa-Oral Initial or Prolonged Back Pain Study (Olanzapine) Condition Aggravated Health (Olanzapine) PS 15 MG/3 DAY Hallucination, Auditory Professional Levotomin Hostility Other (Levomepromazine Schizophrenia, Paranoid Maleate) C Type Risperdal Soliloquy (Risperidone) C Akineton (Biperiden Hydrochloride) C Vegetamin B C Rohipnol (Flunitrazepam) C Pantosin (Pantethine) C Magnesium Oxide C Laxoberon (Sodium Picosulfate) C Zyloric (Allopurinol) C Date:03/09/04ISR Number: 4315328-3Report Type:Expedited (15-DaCompany Report #USA040157786 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Drug Level Increased Professional (Olanzapine)(Olanzap Hallucination, Auditory ine) PS 30 MG DAY Lice Infestation Cogentin(Benzatropin Overdose e Mesilate) C Paranoia Risperidone C Date:03/09/04ISR Number: 4315330-1Report Type:Expedited (15-DaCompany Report #USA040156904 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Apgar Score Low Health Zyprexa-Oral Cleft Lip And Palate Professional (Olanzapine)(Olanzap Maternal Drugs Affecting Company ine) PS Foetus Representative Celexa(Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 2805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/04ISR Number: 4315348-9Report Type:Expedited (15-DaCompany Report #USA031049295 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Health Strattera(Atomoxetin Initial or Prolonged Abnormal Behaviour Professional e Hydrochloride) PS 18 MG/DAY 2 DAY Aggression Company Zyprexa-Oral Asthenia Representative (Olanzapine(Olanzapi Cerebrovascular Accident ne)) SS 2.5 MG/2 DAY Convulsion Clonidine C Hemiparesis Metadate(Methylpheni Medication Error date) C Regressive Behaviour Speech Disorder Staring Date:03/09/04ISR Number: 4315378-7Report Type:Expedited (15-DaCompany Report #JP_030901751 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Zyprex Blood Triglycerides Health (Olanzapine) PS ORAL 10 MG/DAY Increased Professional Brotizolam C ORAL Diarrhoea Company Glycosylated Haemoglobin Representative Increased Other Headache Hepatic Function Abnormal Hyperglycaemia Weight Increased Date:03/09/04ISR Number: 4315380-5Report Type:Expedited (15-DaCompany Report #JP_040202669 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Zyprexa Initial or Prolonged Asthenia Study (Olanzapine) PS ORAL 5 MG/1 DAY Decreased Activity Health Risperdal Dysphagia Professional (Risperidone) C Gamma-Glutamyltransferase Other Tamsolin (Biperiden) C Increased Mevalotin Hepatic Function Abnormal (Pravastatin Hypoaesthesia Sodiuim) C Parkinson'S Disease Lendormin Upper Respiratory Tract (Brotizolam) C Inflammation Laxoberon (Sodium Picosulfate) C Date:03/09/04ISR Number: 4315490-2Report Type:Expedited (15-DaCompany Report #US_010770104 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alopecia Initial or Prolonged Anxiety Other Asthma Blood Glucose Increased Depression Goitre Haemosiderosis 24-Jun-2005 12:19 PM Page: 2806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hair Texture Abnormal Hallucination Headache Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Consumer Humulin-Human Nph Hypothyroidism Insulin (Rdan) Injection Site Reaction (Human Insulin (Rd PS 80 U/DAY Insulin Resistance Prozac-Oral Lower Limb Fracture (Fluoxetine) Malaise (Fluoxetine Mental Disorder Hydrochloride) SS Nausea Zyprexa-Oral Pain (Olanzapine) Palpitations (Olanzapine) SS Pernicious Anaemia Phentermine C Pharmaceutical Product Pondimin Complaint (Fenfluramine Road Traffic Accident Hydrochloride) C Skin Ulcer Levothyroxine C Thyroid Neoplasm Armour Thyroid Vomiting (Thyroid) C Weight Decreased Glucophage Weight Increased (Metformin Hydrochloride) C Avandia (Rosiglitazone Maleate) C Vitamins C Magnesium C Chromium C Reduc (Dexfenfluramine Hydrochloride) C Novolin (Insulin Human Injection, Isophane) C Seroquel (Quetiapine Fumarate) C Date:03/09/04ISR Number: 4315675-5Report Type:Expedited (15-DaCompany Report #USA040259823 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatomegaly Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 20 MG/ IN THE EVENING Ativan (Lorazepam) C Date:03/09/04ISR Number: 4315677-9Report Type:Expedited (15-DaCompany Report #USA040260215 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Health Zyprexa-Oral Initial or Prolonged Ileus Paralytic Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/04ISR Number: 4315680-9Report Type:Expedited (15-DaCompany Report #USA040259861 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Myocardial Infarction Professional (Olanzapine) Other Weight Increased (Olanzapine) PS 30 MG/ 1DAY Benadryl (Diphenhydramine Hydrochloride) C Haldol (Haloperidol) C Date:03/09/04ISR Number: 4315682-2Report Type:Expedited (15-DaCompany Report #USA040259304 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rectal Haemorrhage Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:03/10/04ISR Number: 4314795-9Report Type:Expedited (15-DaCompany Report #200410476DE Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Clexane PS Aventis Initial or Prolonged Haemoglobin Decreased Pharmaceuticals Inc. SUBCUTANEOUS Neutropenia Zyprexa SS ORAL Red Blood Cell Count Multibionta C Decreased White Blood Cell Count Decreased Date:03/10/04ISR Number: 4314946-6Report Type:Direct Company Report #CTU 214210 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypernatraemia Comtan 200 Mg Hyperpyrexia Novartis PS Novartis ORAL 200 MG 3 Infection TIMES ORAL Mental Status Changes Zyprexa 2.5 Mg SS Eli-Lilly ORAL 2.5 MG TWICE Muscle Rigidity DAIL ORAL Neuroleptic Malignant Zocor C Syndrome Sinemet C Warfarin C Flomax C Acetaminophen C Claritin C Lortab C Date:03/10/04ISR Number: 4325744-1Report Type:Expedited (15-DaCompany Report #USA040361617 Age:6 YR Gender:Male I/FU:I Outcome PT Hospitalization - Attention Initial or Prolonged Deficit/Hyperactivity Disorder Bipolar Disorder 24-Jun-2005 12:19 PM Page: 2808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Report Source Product Role Manufacturer Route Dose Duration Health Strattera Professional (Atomoxetine Hydrochloride) PS 60 MG DAY Zyprexa-Oral (Olanzapine ) SS 2.5 NG/2 DAY Date:03/11/04ISR Number: 4315620-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0502021A Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Paxil PS Glaxosmithkline ORAL 20MG Unknown Initial or Prolonged Anger Zoloft SS ORAL 50MG Unknown Arrhythmia Zyprexa SS 10MG Unknown Self Mutilation Suicidal Ideation Suicide Attempt Date:03/11/04ISR Number: 4316421-1Report Type:Expedited (15-DaCompany Report #2004-112776-NL Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Mirtazapine PS ORAL 30 MG QD ORAL 3 WK Initial or Prolonged Professional Lansoprazole SS ORAL 30 MG QD ORAL Clopidogrel SS ORAL 75 MG QD ORAL Simvastatin SS ORAL 40 MG QD ORAL Olanzapine SS ORAL 2.5 MG QD ORAL Risedronate C Lactulose C Senna C Date:03/12/04ISR Number: 4316603-9Report Type:Direct Company Report #USP 56429 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa 10 Mg PS Lilly TABLET Zyrtec 10mg SS Pfizer TABLET Date:03/12/04ISR Number: 4316814-2Report Type:Direct Company Report #USP 56368 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa 10 Mg PS Lilly TABLET Zyrtec SS Pfizer TABLET Date:03/15/04ISR Number: 4317011-7Report Type:Expedited (15-DaCompany Report #2004013789 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Confusional State Professional Olanzapine Disorientation (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 2809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/04ISR Number: 4318228-8Report Type:Expedited (15-DaCompany Report #2004-112776-NL Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Mirtazapine PS ORAL 30 MG QD ORAL Initial or Prolonged Professional Lansoprazole SS ORAL 30 MG QD ORAL Simvastatin SS ORAL 40 MG QD ORAL Olanzapine SS ORAL 2.5 MG QD ORAL Clopidogrel C ORAL 75 MG QD ORAL Risedronate C Lactulose C Senna C Date:03/15/04ISR Number: 4318371-3Report Type:Expedited (15-DaCompany Report #A01200400852 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Health Stilnox - (Zolpidem) Hospitalization - Delirium Professional - Unknown - Unit Initial or Prolonged Dose: Unknown PS 20 MG HS; A FEW WEEKS (Olanzapine) - Unknown - Unit Dose : Unknown SS 10 MG; A FEW WEEKS Efexor (Venlafaxine Hydrochloride) C Lithium C Date:03/15/04ISR Number: 4318705-XReport Type:Expedited (15-DaCompany Report #AU_040207475 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Foreign Zyprexa-Oral Initial or Prolonged Hepatitis Health (Olanzapine) Professional (Olanzapine) PS Other Date:03/15/04ISR Number: 4318948-5Report Type:Expedited (15-DaCompany Report #HQWYE620208MAR04 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Efexor (Venlafaxine Increased Health Hydrochloride, Aspartate Professional Tablet) PS ORAL 37.5 MG 1X Aminotransferase Other PER 1 DAY Increased Efexor (Venlafaxine Blood Lactate Hydrochloride, Dehydrogenase Increased Tablet) SS ORAL 75 MG 1X PER Condition Aggravated 1 DAY Drug Interaction Efexor (Venlafaxine Potentiation Hydrochloride, Drug Toxicity Tablet) SS ORAL 112.5 MG 1X Gamma-Glutamyltransferase PER 1 DAY Increased Efexor (Venlafaxine Liver Disorder Hydrochloride, Tablet) SS ORAL 150 MG 1X PER 1 DAY 24-Jun-2005 12:19 PM Page: 2810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Efexor (Venlafaxine Hydrochloride, Tablet) SS ORAL 225 MG 1X PER 1 DAY Efexor (Venlafaxine Hydrochloride, Tablet) SS ORAL 300 MG 1X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS ORAL 300 MG 1X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS ORAL 600 MG 1X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS ORAL 500 MG 1X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS ORAL 1000 MG 1X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS ORAL 1500 MG 1X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS ORAL 1750 MG 1X PER 1 DAY Depakine Chrono (Valproate Sodium/Valproic Acid, ) SS ORAL 2000 MG 1X PER 1 DAY Entumin (Clotiapine, ) SS ORAL 160 MG1X PER 1 DAY Zyprexa (Olanzapine, ) SS ORAL 10 MG 1X PER 1 DAY Zyprexa (Olanzapine, ) SS ORAL 20 MG 1X PER 1 DAY Eltroxin (Levothyroxine Sodium) C Zocor (Simvastatin) C Plavix (Clopidogrel Sulfaet) C Beloc Zok (Metoprolol Succinate) C 24-Jun-2005 12:19 PM Page: 2811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/04ISR Number: 4318478-0Report Type:Direct Company Report #CTU 214447 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Zyprexa Lilly PS Lilly ORAL PO QD 2 WK Acute Respiratory Distress Syndrome Confusional State Neutropenia Pneumonia Pneumonia Aspiration Renal Failure Acute Sepsis Date:03/16/04ISR Number: 4319009-1Report Type:Expedited (15-DaCompany Report #FR_040303688 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Foreign Zyprexa-Oral Hyperglycaemia Health (Olanzapine) Rhabdomyolysis Professional (Olanzapine) PS 10 MG/1 DAY Company Representative Other Date:03/16/04ISR Number: 4319011-XReport Type:Expedited (15-DaCompany Report #EWC040338246 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Gun Shot Wound Health (Olanzapine) PS 20 MG DAY 2 WK Professional Clonazepam C Company Imovane (Zopicflone) C Representative Other Date:03/16/04ISR Number: 4319013-3Report Type:Expedited (15-DaCompany Report #CA_040306703 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enzyme Abnormality Foreign Zyprexa-Oral Initial or Prolonged Rhabdomyolysis Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG Company Lipitor Representative (Atoravstatin) C Other Date:03/16/04ISR Number: 4319014-5Report Type:Expedited (15-DaCompany Report #CA_040306704 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Disorder Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG Company Representative Other 24-Jun-2005 12:19 PM Page: 2812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/04ISR Number: 4319157-6Report Type:Expedited (15-DaCompany Report #FR_040103388 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Zyprexa-Oral Initial or Prolonged Phosphatase Increased Health (Olanzapine) Other C-Reactive Protein Professional (Olanzapine) PS 10 MG/DAY Increased Other Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Hypothermia Laboratory Test Abnormal Thrombophlebitis Superficial Date:03/16/04ISR Number: 4319166-7Report Type:Expedited (15-DaCompany Report #JP_040202621 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 15 MG/1 DAY Aminotransferase Company Fursennid (Senna Increased Representative Leaf) C Bile Duct Stone Other Biliary Dilatation Cholelithiasis Constipation Oedema Peripheral Pneumonia Tumour Marker Increased Date:03/16/04ISR Number: 4319168-0Report Type:Expedited (15-DaCompany Report #FR_040303674 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Foreign Zyprexa-Oral Initial or Prolonged Distress Syndrome Health (Olanzapine) Diabetic Ketoacidosis Professional (Olanzapine) PS UNKNOWN UNK Hyperglycaemia Other Pancreatitis Renal Failure Date:03/16/04ISR Number: 4319170-9Report Type:Expedited (15-DaCompany Report #FR_040303680 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa-Oral Initial or Prolonged Exposure To Therapeutic Health (Olanzapine) Drugs Professional (Olanzapine) PS UNKNOWN UNK Fall Other Tranzene Overdose (Clorazepate Suicide Attempt Dipotassium) C Alcohol C Ketoderm (Ketoconazole) C Noctamide (Lormetazepam) C 24-Jun-2005 12:19 PM Page: 2813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tercian (Cyamemazine) C Atarax (Hydroxyzine Hydrochloride) C Imovane (Zopiclone) C Augmentin C Mucomyst (Acetylcysteine) C Lysopaine C Oropivalone C Doliprane (Paracetamol) C Bi-Profenid (Ketoprofen) C Myolastan (Tetrazepam) C Lepticur (Tropatepine Hydrochloride) C Loxapac (Loxapine Succinate) C Date:03/16/04ISR Number: 4319210-7Report Type:Expedited (15-DaCompany Report #JP_040202614 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bedridden Foreign Zyprexa Initial or Prolonged Cerebral Atrophy Literature (Olanzapine) PS ORAL 7.5 MG/DAY Condition Aggravated Health Donepezil Dementia Professional Hydrochloride C Disorientation Company Trihexyphenidyl C Disturbance In Attention Representative Excitability Other Muscle Rigidity Nuchal Rigidity Parkinsonism Restlessness Sedation Tremor Date:03/16/04ISR Number: 4319211-9Report Type:Expedited (15-DaCompany Report #JP_030601208 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choreoathetosis Foreign Zyprexa Oral Hospitalization - Dystonia Literature (Olanzapine) Initial or Prolonged Extrapyramidal Disorder Health (Olanzapine) PS 2.5 MG DAY Hypokalaemia Professional Permax (Pergolide On And Off Phenomenon Company Mesylate) SS 750 UG/DAY Psychiatric Symptom Representative Symmetrel Respiratory Arrest Other (Amantadine Soliloquy Hydrochloride) C Suicidal Ideation Levodopa Benserazide Temperature Regulation Hydrochlo C Disorder Depromel Thyroidectomy Partial (Fluvoxamine) C Vocal Cord Disorder Thyradin S (Levothyroxine Sodium) C 24-Jun-2005 12:19 PM Page: 2814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantosin (Pantethine) C Magnesium Oxide C Date:03/16/04ISR Number: 4319212-0Report Type:Expedited (15-DaCompany Report #CA_040306711 Age:22 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retinal Haemorrhage Foreign Zyprexa Oral Consumer (Olanzapine)(Olanzap Other ine) PS Date:03/16/04ISR Number: 4319343-5Report Type:Expedited (15-DaCompany Report #JP_040202648 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haemodialysis Foreign Zyprexa-Oral Hepatic Encephalopathy Health (Olanzapine) Hepatitis Fulminant Professional (Olanzapine) PS 10 MG/DAY Company Tegretol(Carbamazepi Representative ne) C Other Depas (Etizolam) C Benzalin (Nitrazepam) C Date:03/16/04ISR Number: 4319352-6Report Type:Expedited (15-DaCompany Report #GBS040114265 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Olanzapine-Oral Pulmonary Embolism Health (Olanzapine) PS Sudden Death Professional Epilim (Valproate Company Sodium) C Representative Efexor (Venlafaxine Other Hydrochloride) C Temazepam C Date:03/16/04ISR Number: 4319356-3Report Type:Expedited (15-DaCompany Report #GBS040214513 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Zyprexa-Oral Other Drug Toxicity Health (Olanzapine) Renal Impairment Professional (Olanzapine) PS 10 MG/2 DAY Sudden Death Other Lithium Carbonate C Urinary Tract Infection Haloperidol C Extrapyramidal Disorder C Clonazepam C Date:03/16/04ISR Number: 4319487-8Report Type:Expedited (15-DaCompany Report #USA040360885 Age:74 YR Gender:Female I/FU:I Outcome PT Death Alopecia Decubitus Ulcer 24-Jun-2005 12:19 PM Page: 2815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Dementia Diarrhoea Report Source Product Role Manufacturer Route Dose Duration Muscular Weakness Consumer Zyprexa PS 7 MON Oral Intake Reduced Tegretal Oxygen Saturation (Carbamazepine) C Decreased Dilantin (Phenytoin Paralysis Sodium) C Pyrexia Skin Disorder White Blood Cell Count Increased Date:03/16/04ISR Number: 4319488-XReport Type:Expedited (15-DaCompany Report #USA040360438 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Zyprexa PS 5 MG AT Initial or Prolonged Diverticulitis BEDTIME 3 YR Other Headache Aspirin C Monoplegia Paxil (Paroxetine Palpitations Hydrochloride) C Post Procedural Mirapex (Mirapex) C Complication Prednisone C Date:03/16/04ISR Number: 4319542-2Report Type:Expedited (15-DaCompany Report #US_031299506 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Consumer Zyprexa-Oral Other Diabetic Hyperosmolar Health (Olanzapine) Coma Professional (Olanzapine) PS Drug Toxicity Electrolyte Imbalance Glucose Urine Present Hyperglycaemia Injury Date:03/16/04ISR Number: 4319620-8Report Type:Expedited (15-DaCompany Report #USA040156450 Age:8 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Aggression Other Blood Pressure Decreased Cerebral Palsy Confusional State Dyspepsia Dyspnoea Feeling Abnormal Feeling Cold Grand Mal Convulsion Influenza Loss Of Consciousness Prescribed Overdose Psychomotor Hyperactivity Pyrexia Speech Disorder 24-Jun-2005 12:19 PM Page: 2816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Strattera (Atomoxetine Hydrochloride) PS 80 MG DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 1.2 MG/IN THE EVENING Zoloft (Sertraline Hydrochloride) C Lexapro (Escitalopram) C Abilify (Aripiprazole) C Dilantin (Phenytoin Sodium) C Clonidine C Date:03/16/04ISR Number: 4319627-0Report Type:Expedited (15-DaCompany Report #USA030638927 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Zyprexa-Oral Hospitalization - Hypersomnia (Olanzapine) Initial or Prolonged (Olanzapine) PS 10 MG/2 DAY Exelon (Rivastigmine Tartrate) C Neurontin (Gabapentin) C Norvasc (Amlodipine Besilate) C Aspirin C Vitamint E C Vitamin B C Date:03/16/04ISR Number: 4319974-2Report Type:Expedited (15-DaCompany Report #USA040360872 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Evista (Raloxifene Hydrochloride) SS Haldol (Haloperidol) C Dilantin (Phenytoin Sodium) C Date:03/16/04ISR Number: 4320048-5Report Type:Expedited (15-DaCompany Report #USA-2003-0011528 Age:47 YR Gender:Male I/FU:F Outcome PT Death Bronchitis Chronic Cerebral Infarction Chronic Obstructive Pulmonary Disease 24-Jun-2005 12:19 PM Page: 2817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Drug Screen Positive Emphysema Report Source Product Role Manufacturer Route Dose Duration Pleural Adhesion Health Morphine Sulfate Pneumonitis Professional (Morphine Sulfate) PS Pyelonephritis Chronic Other Hydrocodone Renal Disorder Bitartrate Scar (Hydrocodone Bitartrate) SS Dihydrocodeine/Caffe ine/Acetaminophen (Dihydrocodeine, Caffeine, Paracetamol) SS Acetaminophen (Paracetamol) SS Olanzapine (Olanzapine) SS Amitriptyline (Amitriptyline) SS Trazodone (Trazodone) SS Nicotine (Nicotine) SS Caffeine (Caffeine) SS Bupropion (Amfebutamone) SS Date:03/17/04ISR Number: 4318845-5Report Type:Direct Company Report #CTU 214566 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Distension Zyprexa 10 Mg 5 Mg Anxiety Eli Lilly PS Eli Lilly 5 MG PM Diarrhoea Drug Effect Decreased Dysarthria Endocrine Disorder Infertility Influenza Like Illness Insomnia Myalgia Date:03/17/04ISR Number: 4320135-1Report Type:Expedited (15-DaCompany Report #HQWYE618308MAR04 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Efexor (Venlafaxine Initial or Prolonged Phosphokinase Increased Professional Hydrochloride, Other Drug Interaction Tablet) PS ORAL 150 MG 1X PER Lip Dry 1 DAY, ORAL Mucosal Dryness Lithiofor (Lithium, Parkinsonism ) SS ORAL 990 MG 1X PER Seborrhoea 1 DAY; ORAL Sedation Risperdal Skin Turgor Decreased (Risperidone) SS ORAL 0.5 MG 1X PER 1 DAY; ORAL Risperdal (Risperidone) SS UNKNOWN 0.25 MG 2X PER 1 DAY; 24-Jun-2005 12:19 PM Page: 2818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report UNKNOWN Temesta (Lorazepam, Unspec) SS ORAL 0.5 MG 1X PER 1 DAY; ORAL Zyprexa (Olanzapine) SS ORAL 2.5 MG 1X PER 1 DAY; ORAL 60 DAY Zyprexa (Olanzapine) SS ORAL 7.5 MG 1X PER 1 DAY; ORAL 2 DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG 1X PER 1 DAY; ORAL Pantozol (Pantoprazole) C Panadol (Paracetamol) C Date:03/17/04ISR Number: 4320239-3Report Type:Expedited (15-DaCompany Report #2004014597 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zeldox (Capsules) Initial or Prolonged White Blood Cell Count Health (Ziprasidone) PS ORAL 120 MG Decreased Professional (DAILY), ORAL Olanzapine (Olanzapine) SS ORAL 20 MG (DAILY), ORAL Flupentixol (Flupentixol) SS ORAL 10 MG (DAILY), ORAL Flupntixol Decanoate (Flupentixol Decanoate SS INTRAMUSCULAR INTRAMUSCULAR Lorazepam (Lorazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/18/04ISR Number: 4319494-5Report Type:Direct Company Report #CTU 214739 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Olanzapine Sun Obsessive-Compulsive Pharmaceutical PS Sun Pharmaceutical 10 MG Disorder Date:03/19/04ISR Number: 4320460-4Report Type:Direct Company Report #CTU 214775 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Zyprexa PS Syndrome 24-Jun-2005 12:19 PM Page: 2819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/04ISR Number: 4322478-4Report Type:Expedited (15-DaCompany Report #A01200400852 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Health Stilnox - (Zolpidem) Hospitalization - Delirium Professional - Unknown - Unit Initial or Prolonged Dose : Unknown PS 20 MG HS; A FEW WEEKS (Olanzapine) - Unknown - Unit Dose : Unknown SS 10 MG Efexor (Vanlafaxine Hydrochloride) C Lithium C Date:03/19/04ISR Number: 4322494-2Report Type:Expedited (15-DaCompany Report #GBS040214409 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Prozac-Oral Hospitalization - Diabetic Ketoacidosis Health (Fluoxetine) Initial or Prolonged Malaise Professional (Fluoxetine Other Multi-Organ Failure Company Hydrochloride) PS 20 MG/ Neuroleptic Malignant Representative Olanzapine-Oral Syndrome Other (Olanzapine) SS 10 MG/ Date:03/22/04ISR Number: 4321113-9Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0320863A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Activity Lamictal PS Glaxosmithkline ORAL 100MG Per day 20 DAY Initial or Prolonged Depressed Level Of Escitalopram SS ORAL 15MG Per day 77 DAY Consciousness Lorazepam SS ORAL 3MG Per day 34 DAY Exanthem Olanzapine SS ORAL 5MG Per day 24 DAY Fall Mirtazapine SS UNKNOWN Gait Disturbance Haemoglobin Decreased Haemothorax Rib Fracture Sedation White Blood Cell Count Decreased Date:03/22/04ISR Number: 4321234-0Report Type:Direct Company Report #CTU 214960 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Zyprexa PS Cognitive Disorder Incoherent Muscle Rigidity Tremor 24-Jun-2005 12:19 PM Page: 2820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/04ISR Number: 4321855-5Report Type:Direct Company Report #CTU 214954 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Vioxx 25 Mg PS ORAL ONE PO QD Zyprexa 10 Mg SS ORAL ONE PO QD Date:03/22/04ISR Number: 4323332-4Report Type:Expedited (15-DaCompany Report #S04-FRA-01097-01 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Ebixa /Den/ Oedema Peripheral Health (Memantine Professional Hydrochloride0 PS ORAL 20 MG QD PO Other Zyprexa (Olanzapine) SS Perindopril C Acetylsalicylate Lysine C Telmisartan C Salbutamol C Date:03/22/04ISR Number: 4324846-3Report Type:Expedited (15-DaCompany Report #DSA_24070_2004 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Tavor PS ORAL VAR DAILY PO Initial or Prolonged Blood Pressure Health Aurorix SS ORAL 750 MG DAILY Immeasurable Professional PO Circulatory Collapse Other Aurorix SS ORAL 600 MG DAILY Drug Interaction PO Haemorrhage Dipiperon SS ORAL 40 MG DAILY Head Injury PO Loss Of Consciousness Zyprexa SS ORAL 7.5 MG DAILY PO Zyprexa SS ORAL 5 MG DAILY PO Date:03/23/04ISR Number: 4323595-5Report Type:Periodic Company Report #US_0402100494 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Cialis (Tadalafil) PS 20 MG Olanzapine-Oral (Olanzapine) SS 10 MG/DAY Sennoside A C Lisinopril C Hydrochlorothiazide C Metformin C Lorazepam C Glyburide C Felodipine C Asa (Acetylsalicylic Acid) C Singulair (Montelukast Sodium) C 24-Jun-2005 12:19 PM Page: 2821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/04ISR Number: 4323370-1Report Type:Direct Company Report #CTU 215157 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Health Olanzapine Zydis Intervention to Professional 20mg Qhs PS Zydis 06/03-2/12/04 Prevent Permanent Impairment/Damage Date:03/24/04ISR Number: 4323696-1Report Type:Direct Company Report #CTU 215216 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Olanzapine PS ORAL 10 MG ONCE PO Confusional State Venlafaxine Hcl C Flushing Hyperthermia Neuroleptic Malignant Syndrome Psychomotor Hyperactivity Respiratory Disorder Tachycardia Date:03/24/04ISR Number: 4325279-6Report Type:Expedited (15-DaCompany Report #JP_040202705 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Albumin Increased Foreign Zyprexa-Oral Hepatic Steatosis Health (Olanzapine) PS 10 MG/1 DAY Hepatomegaly Professional Risperdal Hyperlipidaemia Company (Risperidone) C Protein Total Increased Representative Wypax (Lorazepam) C Other Tasmolin (Biperiden) C Date:03/24/04ISR Number: 4325332-7Report Type:Expedited (15-DaCompany Report #JP_040202585 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa-Oral Subarachnoid Haemorrhage Study (Olanzapine) Health (Olanzapine) PS 10 MG/1 DAY Professional Magnesium Oxide C Other Akineton (Biperiden Hydrochloride) C Serenace (Haloperidol) C Pursennide (Senna Leaf) C Lexotan (Bromazepam) C Lasix (Furosemide) C Artane (Trihexyphenidyl Hydrochloride) C Vegetamin B C Alosenn C 24-Jun-2005 12:19 PM Page: 2822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/04ISR Number: 4325346-7Report Type:Expedited (15-DaCompany Report #JP_040202641 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Foreign Zyprexa-Oral Hyperglycaemia Health (Olanzapine) Hypoglycaemia Professional (Olanzapine) PS 20 MG/DAY Company Mercazole Representative (Thiamazole) C Other Thyradin S (Levothyroxine Sodium) C Date:03/24/04ISR Number: 4325348-0Report Type:Expedited (15-DaCompany Report #EWC040237964 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa-Oral Initial or Prolonged Injury Health (Olanzapine) Parkinson'S Disease Professional (Olanzapine) PS 5 MG/DAY Rhabdomyolysis Other Zoloft (Sertraline Hydrochloride) C Madopar C Stilnoct (Zolpidem Tartrate) C Losec (Omeprazole) C Sobril (Oxazepam) C Date:03/24/04ISR Number: 4325350-9Report Type:Expedited (15-DaCompany Report #JP_031102236 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/DAY Aminotransferase Company Evamyl Increased Representative (Lormetazepam) C Blood Cholinesterase Other Alosenn C Increased Magnesium Oxide C Blood Lactate Nitorol (Isosorbide Dehydrogenase Increased Dinitrate) C Blood Osmolarity Bayaspirin Decreased (Acetylsalicylic Blood Sodium Decreased Acid) C Decreased Appetite Benzalin Gamma-Glutamyltransferase (Nitrazepam) C Increased Hepatic Function Abnormal Marrow Hyperplasia Nasopharyngitis Pancytopenia Splenomegaly Date:03/24/04ISR Number: 4325423-0Report Type:Expedited (15-DaCompany Report #JP_040302766 Age:33 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Foreign Zyprexa-Oral Anorexia Study (Olanzapine) Condition Aggravated Health (Olanzapine) PS 5 MG/1 DAY Depression Professional Rohipnol Insomnia Other (Flunitrazepam) C Nasopharyngitis Myslee (Zolpidem Nightmare Tartrate) C Psychiatric Symptom Akineton (Biperiden Suicidal Ideation Hydrochloride) C Treatment Noncompliance Date:03/24/04ISR Number: 4325455-2Report Type:Expedited (15-DaCompany Report #US_0403101537 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa-Oral Initial or Prolonged Blood Creatine Professional (Olanzapine) Phosphokinase Increased Other (Olanzapine) PS Confusional State Trazodone C Coordination Abnormal Disorientation Drug Screen Positive Hallucinations, Mixed Incoherent Intention Tremor Mental Status Changes Rhabdomyolysis Thought Broadcasting Date:03/24/04ISR Number: 4325483-7Report Type:Expedited (15-DaCompany Report #GBS040314562 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa-Oral Initial or Prolonged Pancytopenia Health (Olanzapine) Professional (Olanzapine) PS 12.5 MG Other Date:03/24/04ISR Number: 4325510-7Report Type:Expedited (15-DaCompany Report #USA040361576 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) Other Spinal Fracture Company (Olanzapine) PS 10 MG/1 DAY Representative Neurontin (Gabapentin) C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/04ISR Number: 4325514-4Report Type:Expedited (15-DaCompany Report #USA040361707 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Rigidity Health Zyprexa Oral Blood Creatine Professional (Olanzapine)(Olanzap Phosphokinase Increased Company ine) PS 10 MG DAY Feeling Jittery Representative Elavil Intestinal Ischaemia (Amitriptyline Muscle Rigidity Hydrochloride) C Neuroleptic Malignant Remeron Syndrome (Mirtazapine) C Pain Librax C Date:03/24/04ISR Number: 4325521-1Report Type:Expedited (15-DaCompany Report #FR_040103467 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Zyprexa-Oral Bradyarrhythmia Health (Olanzapine) Syncope Professional (Olanzapine) PS 5 MG/1 DAY Other Prozac (Fluoxetine Hydrochloride) C Imovane (Zopiclone) C Tercian (Cyamemazine) C Temesta (Lorazepam) C Date:03/24/04ISR Number: 4325545-4Report Type:Expedited (15-DaCompany Report #EWC040338332 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG Professional Company Representative Other Date:03/24/04ISR Number: 4325547-8Report Type:Expedited (15-DaCompany Report #DE_040213027 Age:20 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Condition Aggravated Fall Haemolytic Anaemia Neutropenia Platelet Count Decreased Platelet Count Increased White Blood Cell Count 24-Jun-2005 12:19 PM Page: 2825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Company Multibionta C Representative Clexane Other (Heparin-Fraction, Sodium Salt) C Fortimel C Date:03/24/04ISR Number: 4325596-XReport Type:Expedited (15-DaCompany Report #USA040361200 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Zyprexa-Oral Initial or Prolonged Dysarthria Professional (Olanzapine) Electrolyte Imbalance (Olanzapine) PS 5 MG Gait Disturbance Zoloft (Sertraline Hydrochloride) C Elavil (Amitriptyline Hydrochloride) C Date:03/24/04ISR Number: 4325678-2Report Type:Expedited (15-DaCompany Report #FR_040303729 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Psychotic Disorder Health (Olanzapine) Pyelonephritis Acute Professional (Olanzapine) PS 5 MG/1 DAY Other Mepronizine C Noctran C Tercian (Cyamemazine) C Athymil (Mianserin Hydrochloride) C Kenzen (Candesartan Cilexetil) C Date:03/24/04ISR Number: 4325684-8Report Type:Expedited (15-DaCompany Report #USA040259765 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Symbyax - Olanzapine Initial or Prolonged Haematemesis Health 6mg / Fluoxetine Haematochezia Professional 25mg (Olanzapin PS Haemorrhage Procardia Incoherent (Nifedipine) C Pain Antacal (Amlodipine Vomiting Besilate) C Lipitor (Atorvastatin) C Lithium C 24-Jun-2005 12:19 PM Page: 2826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/04ISR Number: 4325688-5Report Type:Expedited (15-DaCompany Report #USA040361534 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Symbyax - Olanzapine Loss Of Consciousness Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Date:03/24/04ISR Number: 4325710-6Report Type:Expedited (15-DaCompany Report #EWC040338330 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Olanzapine-Oral Health (Olanzapine) PS 15 MG Professional Micardis Company (Telmisartan) C Representative Selektine Other (Pravastatin Sodium) C Metformin C Date:03/24/04ISR Number: 4325713-1Report Type:Expedited (15-DaCompany Report #DE_040313182 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 10 MG DAY 2 MON Company Zocor (Simvastatin) C Representative Doxepin C Other Date:03/24/04ISR Number: 4325717-9Report Type:Expedited (15-DaCompany Report #DE_040313156 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zyprexa-Oral Initial or Prolonged Drug Interaction Health (Olanzapine) Other Fall Professional (Olanzapine) PS 7.5 MG DAY Feeling Abnormal Other Aurorix Head Injury (Moclobemide) C Loss Of Consciousness Tavor (Lorazepam) C Orthostatic Hypotension Dipiperon Supraventricular (Pipamperone) C Tachycardia Ventricular Extrasystoles Wound Haemorrhage Date:03/24/04ISR Number: 4325722-2Report Type:Expedited (15-DaCompany Report #DE_040313131 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oarl Initial or Prolonged Prolonged Health (Olanzapine) Hypokalaemia Professional (Olanzapine) PS 15 MG AT Company BEDTIME Representative Distraneurin Other (Clomethiazole 24-Jun-2005 12:19 PM Page: 2827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Edisilate) C Date:03/24/04ISR Number: 4325724-6Report Type:Expedited (15-DaCompany Report #JP_040202589 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Zyprexa-Oral Initial or Prolonged Abdominal Pain Study (Olanzapine) Other Alanine Aminotransferase Health (Olanzapine) PS 10 MG/1 DAY Increased Professional Tasmolin (Biperiden) C Blood Creatine Other Rohypnol Phosphokinase Increased (Flunitrazepam) C Enterocolitis Infectious Neo F Lase C Gamma-Glutamyltransferase Seroquel (Quetiapine Increased Fumarate) C Gastric Ulcer Nitrazepam C Haemorrhoids Contomin Ileus (Chlorpromazine Nasopharyngitis Hydrochloride) C Pyrexia Magnesium Oxide C Urinary Retention Vegetamin B C Levotomin (Levomepromazine Maleate) C Serenace (Haloperidol) C Amoban (Zopiclone) C Prolmon (Protoporphyrin Sodium) C Date:03/24/04ISR Number: 4325762-3Report Type:Expedited (15-DaCompany Report #JP_040302743 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Zyprexa-Oral Other Cardio-Respiratory Arrest Health (Olanzapine) Choking Professional (Olanzapine) PS 5 MG/2 DAY Loss Of Consciousness Company Seroquel (Quetiapine Treatment Noncompliance Representative Fumarate) C Vomiting Other Akineton (Biperiden Hydrochloride) C Landsen (Clonazepam) C Nitrazepam C Horizon (Diazepam) C Date:03/24/04ISR Number: 4325763-5Report Type:Expedited (15-DaCompany Report #JP_040302741 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Akineton (Biperiden Representative Hydrochloride) C Other Serenace (Haloperidol) C Hiberna (Promethazine 24-Jun-2005 12:19 PM Page: 2828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:03/24/04ISR Number: 4325777-5Report Type:Expedited (15-DaCompany Report #USA040361523 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa-Oral Initial or Prolonged Pulmonary Embolism Professional (Olanzapine) (Olanzapine) PS 30 MG DAY Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Abilify (Aripiprazole) C Haldol Decanoate (Haloperidol Decanoate) C Depakote (Valproate Semisodium) C Provigil (Modafinil) C Date:03/24/04ISR Number: 4325835-5Report Type:Expedited (15-DaCompany Report #GBS040214375 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Olanzapine-Oral Coronary Artery Stenosis Health (Olanzapine) PS 2.5 MG DAY Coronary Artery Professional Thrombosis Other Myocardial Infarction Date:03/24/04ISR Number: 4325843-4Report Type:Expedited (15-DaCompany Report #GBS040214423 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine-Oral Loss Of Consciousness Health (Olanzapine) PS 5 MG DAY Professional Company Representative Other Date:03/25/04ISR Number: 4347811-9Report Type:Periodic Company Report #USA040157101 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Consumer Forteo Infection (Teriparatide) PS Injection Site Rash Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) SS Ativan (Lorazepam) C Fosamax (Alendronate Sodium) C Calcium C Remeron 24-Jun-2005 12:19 PM Page: 2829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mirtazapine) C Premarin (Estrogens Conjugated) C Date:03/26/04ISR Number: 4323802-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12517470 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Olanzapine PS Face Oedema Lamictal C taken for several years Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Lithium I taken for several years Date:03/26/04ISR Number: 4326620-0Report Type:Direct Company Report #CTU 215408 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Zyprexa PS 10 MG ONCE Gun Shot Wound DAILY 1X DAY Date:03/27/04ISR Number: 4331530-9Report Type:Expedited (15-DaCompany Report #JP_040302741 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Completed Suicide Foreign Zyprexa Health (Olanzapine ) PS ORAL 20 MG DAY Professional Akineton (Biperiden Company Hydrochloride) C Representative Serenace Other (Haloperidol) C OPHTHALMIC Hiberna (Promethazine Hydrochloride) C ORAL Date:03/29/04ISR Number: 4330250-4Report Type:Expedited (15-DaCompany Report #DSA_24006_2004 Age:80 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abasia Initial or Prolonged Antidepressant Drug Level Increased Asthenia Decreased Activity Drug Interaction Drug Level Increased Exanthem Fall Haemothorax Infection Leukopenia Normochromic Normocytic Anaemia Oral Intake Reduced Pruritus 24-Jun-2005 12:19 PM Page: 2830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rib Fracture Report Source Product Role Manufacturer Route Dose Duration Foreign Temesta PS ORAL 1.5 MG Q DAY Health PO Professional Temesta SS ORAL 3 MG Q DAY PO Other Temesta SS ORAL 0.5 MG Q DAY PO Temesta SS ORAL 1 MG Q DAY PO Cipralex /Den/ SS Cipralex /Den/ SS Cipralex /Den/ SS Lamictal SS 100 MG Q DAY Lamictal SS Zyprexa SS 5 MG Q DAY Zyprexa SS 2.5 MG Q DAY Remeron SS Orfiril C Date:03/29/04ISR Number: 4331463-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304515 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Study Risperidone Initial or Prolonged Gallbladder Disorder Health (Risperidone) Headache Professional Unspecified PS 1 TABLET; 1 Hepatitis B TABLETS; 2 Hepatomegaly TABLET Vomiting Olanzapine (Olanzapine) SS 1 TABLET; 1 TABLET; 2 TABLETS Quetiapine (Quetiapine) SS 1 TABLET; 1 TABLET; 2 TABLETS Ziprasidone (Ziprasidone) Tablets SS 1 TABLET; 1 TABLET; 2 TABLET Perphenazine (Perphenazine) SS ONE TABLET; 1 TABLETS; 2 TABLETS Date:03/29/04ISR Number: 4336072-2Report Type:Periodic Company Report #USA040155788 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Strattera Prescribed Overdose Professional (Atomoxetine Company Hydrochloride) PS 25 MG/DAY Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 30 MG/DAY 24-Jun-2005 12:19 PM Page: 2831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Adderall C Date:03/29/04ISR Number: 4336135-1Report Type:Periodic Company Report #USA040155894 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa-Oral Decreased Appetite (Olanzapine) Dizziness (Olanzapine) PS 2 WK Drug Effect Decreased Strattera Heart Rate Increased (Atomoxetine Homicidal Ideation Hydrochloride) SS 60 MG/DAY Peripheral Coldness Depakote (Valproate Poor Peripheral Semisodium) C Circulation Tegretal Prescribed Overdose (Carbamazepine) C Tachycardia Date:03/29/04ISR Number: 4336175-2Report Type:Periodic Company Report #USA040258199 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retching Consumer Zyprexa Zydis-Dispersible (Olanzapine) (Olanzapine) PS 15 MG/DAY Strattera (Atomoxetine Hydrochloride) SS Remeron (Mirtazapine) C Trileptal (Oxcarbazepine) C Lexapro (Escitalopram) C Date:03/29/04ISR Number: 4336726-8Report Type:Periodic Company Report #USA040258095 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Health Strattera Professional (Atomoxetine Hydrochloride) PS 160 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Zoloft(Sertraline Hydrochloride) C Date:03/29/04ISR Number: 4336753-0Report Type:Periodic Company Report #USA040156208 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperphagia Consumer Zyprexa-Oral Increased Appetite (Olanzapine) Somnolence (Olanzapine) PS 5 MG/AT Weight Increased BEDTIME 24-Jun-2005 12:19 PM Page: 2832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Strattera(Atomoxetin e Hydrochloride) SS 60 MG/DAY, A FEW MONTHS Date:03/29/04ISR Number: 4336787-6Report Type:Periodic Company Report #USA040156251 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Strattera Initial or Prolonged Anger (Atomoxetine Crying Hydrochloride) PS 60 MG/DAY Drug Ineffective Zyprexa-Oral Mood Swings (Olanzapine) Tic (Olanzapine) SS 5 MG/IN THE Weight Increased MORNING Abilify (Aripirazole0 C Tripleptal (Oxcarbazepine) C Seroquel (Quetiapien Fumarate) C Lexapro (Escitalopram) C Singulair (Montelukast Sodium) C Date:03/29/04ISR Number: 4337920-2Report Type:Periodic Company Report #USA040157906 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Strattera Aggression (Atomoxetine Anger Hydrochloride) PS 18 MG/DAY Attention Zyprexa-Oral Deficit/Hyperactivity (Olanzapine) Disorder (Olanzapine) SS 15 MG/1 DAY Constipation Imipramine C Drug Ineffective Clonidine C Drug Interaction Dyspnoea Dysuria Fight In School Hunger Hyperphagia Insomnia Intentional Self-Injury Irritability Oppositional Defiant Disorder Weight Increased Date:03/29/04ISR Number: 4337930-5Report Type:Periodic Company Report #USA040157688 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swelling Face Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 1.25 MG/IN 24-Jun-2005 12:19 PM Page: 2833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report THE EVENING Strattera (Atomoxetine Hydrochloride) SS 10 MG Date:03/29/04ISR Number: 4338595-9Report Type:Periodic Company Report #USA040258763 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Strattera Diarrhoea (Atomoxetine Dry Mouth Hydrochloride) PS 40 MG/DAY Dysgeusia Zyprexa-Oral Dyspepsia (Olanzapine) Fatigue (Olanzapine) SS Gastrointestinal Pain Paxil (Paroxetine Weight Decreased Hydrochloride) C Weight Increased Date:03/29/04ISR Number: 4339055-1Report Type:Periodic Company Report #USA040258370 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Strattera Erectile Dysfunction (Atomoxetine Paranoia Hydrochloride) PS Zyprexa (Olanzapine) SS 10 MG/DAY Date:03/29/04ISR Number: 4342196-6Report Type:Periodic Company Report #USA031254108 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Consumer Strattera Retching (Atomoxetine Hydrochloride) PS 25 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS Date:03/29/04ISR Number: 4347026-4Report Type:Periodic Company Report #USA040259392 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Of Relaxation Consumer Symbyax-Olanzapine Medication Error 6mg / Fluoxetine 25mg (Olanxapin PS 1 DSG FORM/IN THE EVENING Strattera (Atomoxetine Hydrochloride) SS 80 MG/DAY Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4348270-2Report Type:Periodic Company Report #USA030844301 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Strattera Anorexia (Atomoxetine Expressive Language Hydrochloride) PS Disorder Zyprexa-Oral Eye Rolling (Olanzapine) Fatigue (Olanzapine) SS 5 MG 1 YR Juvenile Arthritis Adderall C Somnolence Folic Acid C Weight Decreased Date:03/29/04ISR Number: 4348274-XReport Type:Periodic Company Report #USA030844309 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Strattera Anorexia (Atomoxetine Expressive Language Hydrochloride) PS Disorder Zyprex-Oral Eye Rolling (Olanzapine) Fatigue (Olanzapine) SS 5 MG/DAY 1 YR Juvenile Arthritis Adderall C Somnolence Folic Acid C Weight Decreased Date:03/29/04ISR Number: 4349574-XReport Type:Periodic Company Report #USA031253746 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bilateral Breast Buds Health Zyprexa-Oral Fat Tissue Increased Professional (Olanzapine) Weight Increased Company (Olanzapine) PS Representative Strattera (Atomoxetine Hydrochloride) SS Clonidine C Adderall C Trazadone(Trazodone) C Date:03/30/04ISR Number: 4332715-8Report Type:Expedited (15-DaCompany Report #JP_040302805 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Foreign Zyprexa-Oral Initial or Prolonged Blood Lactate Study (Olanzapine) Dehydrogenase Increased Health (Olanzapine) PS 10 MG/1 DAY Blood Potassium Decreased Professional Tasmolin (Biperiden) C Blood Triglycerides Other Levotomin Increased (Levomepromazine Depressed Level Of Maleate) C Consciousness Lexotan (Bromazepam) C Eating Disorder Aspara K (Aspartate Potassium) C Alinamin F (Fursultiamine) C 24-Jun-2005 12:19 PM Page: 2835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/04ISR Number: 4332831-0Report Type:Expedited (15-DaCompany Report #A02200400913 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Stilnox (Zolpidem) PS ORAL 5 MG, OD, Initial or Prolonged Somnolence Health ORAL Professional Sinemet Other (Carbidopa/Levodopa) , Tablet, 110 Mg SS ORAL 110 MG, BID, ORAL Zyprexa (Olanzapine), Tablet, 1 Df, Oral SS ORAL 1 DF OD, ORAL Motilium "Janssen-Cilag", (Domperidone), Tablet, 10 Mg SS ORAL 10 MG TID, ORAL Date:03/31/04ISR Number: 4330795-7Report Type:Expedited (15-DaCompany Report #USA030741953 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Consumer Zyprexa-Oral Other Heart Rate Increased (Olanzapine) (Olanzapine) PS Adderall C Trazadone C Marijuana C Wellbutrin (Bupropion Hydrochloride) C Date:03/31/04ISR Number: 4330824-0Report Type:Expedited (15-DaCompany Report #USA040361626 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hip Arthroplasty Consumer Forteo Knee Arthroplasty (Teriparatide) PS Skin Disorder Zyprexa-Oral (Olanzapine) SS 5 MG Lactulose C Celebrex (Celecoxib) C Folic Acid C Lisinopril C Hydrochlorothiazide C Synthroid (Levothyroxine Sodium) C Allopurinol C Ditropan (Oxybutynin) C Xanax (Alprazolam) C Milk Of Magnesia C Coumadin (Warfarin Sodium) C Remeron (Mirtazxapine) C Effexor (Venlafaxine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4330825-2Report Type:Expedited (15-DaCompany Report #US_0403101674 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Organ Failure Consumer Zyprexa-Oral Hospitalization - (Olanzapine) Initial or Prolonged (Olanzapine) PS Date:03/31/04ISR Number: 4330826-4Report Type:Expedited (15-DaCompany Report #USA040362331 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Weight Increased (Olanzapine) (Olanzapine) PS 2.5 MG/ 2 DAY 2 MON Strattera(Atomoxetin e Hydrochloride) SS 25 MG DAY 3 MON Ritalin La (Methylphenidate Hydrochloride) C Focalin (Focalin) C Date:03/31/04ISR Number: 4330827-6Report Type:Expedited (15-DaCompany Report #USA040361920 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Zyprexa-Oral Initial or Prolonged Vision Blurred Professional (Olanzapine) (Olanzapine) PS 15 MG DAY Lithium C Date:03/31/04ISR Number: 4330828-8Report Type:Expedited (15-DaCompany Report #USA040362037 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Impairment Consumer Zyprexa-Oral Initial or Prolonged Psychotic Disorder (Olanzapine) Tremor (Olanzapine) PS 30 MG Weight Abnormal Depakote (Valproate Semisodium) C Benztropine C Date:03/31/04ISR Number: 4331306-2Report Type:Expedited (15-DaCompany Report #JP_040302743 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Zyprexa-Oral Other Cardio-Respiratory Arrest Health (Olanzapine) Choking Professional (Olanzapine) PS 5 MG/2 DAY Loss Of Consciousness Company Seroquel (Quetiapine Refusal Of Treatment By Representative Fumarate) C Patient Other Akineton (Biperiden Vomiting Hydrochloride) C Landsen (Clonazepam) C Nitrazepam C Horizon (Diazepam) C 24-Jun-2005 12:19 PM Page: 2837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4331427-4Report Type:Expedited (15-DaCompany Report #DE_040313221 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Fatigue Health (Olanzapine) Headache Professional (Olanzapine) PS 5 MG DAY Date:03/31/04ISR Number: 4332109-5Report Type:Expedited (15-DaCompany Report #S04-SWI-00443-01 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Cipralex Initial or Prolonged Increased Health (Escitalopram) PS ORAL 5 MG QD PO Depressed Level Of Professional Cipralex Consciousness Other (Escitalopram) SS ORAL 10 MG QD PO Dermatitis Allergic Cipralex Drug Level Increased (Escitalopram) SS ORAL 10 MG QD PO Exanthem Cipralex Fall (Escitalopram) SS ORAL 15 M QD PO Feeding Disorder Lamictal "Burroughs Haematocrit Decreased Wellcome" Haemoglobin Decreased (Lamotrigine) SS "Burroughs Wellcome" ORAL 100 MG QD PO Haemothorax Lamictal "Burroughs Leukopenia Wellcome" Pruritus (Lamotrigine) SS "Burroughs Wellcome" Rib Fracture Zyprexa (Olanzapine) SS ORAL 2.5 MG QD PO Urinary Tract Infection Zyprexa (Olanzapine) SS ORAL 5 MG QD PO Walking Disability Remeron (Mirtazapine) C Temesta (Lorazepam) C Date:03/31/04ISR Number: 4332151-4Report Type:Expedited (15-DaCompany Report #GBS040314594 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Foreign Zyprexa Neutropenia Health (Olanzapine) PS ORAL 10 MG White Blood Cell Count Professional Sertraline C Decreased Other Gliclazide C Atropine Sulfate C Dexamethasone C Date:03/31/04ISR Number: 4332152-6Report Type:Expedited (15-DaCompany Report #EWC040338551 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Generalised Oedema Foreign Zyprexa Initial or Prolonged Oesophagitis Health (Olanzapine) PS ORAL 20 MG/1 DAY Psychotic Disorder Professional Tavor (Lorazepam) C Stevens-Johnson Syndrome Company Aulin (Nimesulide) C Stomatitis Representative Tonsillitis Other Weight Increased 24-Jun-2005 12:19 PM Page: 2838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4332153-8Report Type:Expedited (15-DaCompany Report #EWC040338491 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haemodialysis Foreign Olanzapine-Oral Rhabdomyolysis Health (Olanzapine) PS 10 MG/1 DAY Professional Other Date:03/31/04ISR Number: 4332154-XReport Type:Expedited (15-DaCompany Report #EWC040338450 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG DAY Professional Company Representative Other Date:03/31/04ISR Number: 4332163-0Report Type:Expedited (15-DaCompany Report #EWC040338435 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Olanzapine Other Loss Of Consciousness Health (Olanzapine) PS ORAL 2.5 MG/1 DAY Nervous System Disorder Professional Flux Company (Sodium Fluoride) C Representative Sifrol Other (Pramipexole Dihydrochloride) C Lisinopril C Epixian C Date:03/31/04ISR Number: 4332166-6Report Type:Expedited (15-DaCompany Report #EWC040338419 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Zyprexa Cardiomyopathy Health (Olanzapine) PS ORAL 10 MG/1 DAY Professional Temesta Other (Lorazepam) C Date:03/31/04ISR Number: 4332167-8Report Type:Expedited (15-DaCompany Report #CA_040306759 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Zyprexa Attack Health (Olanzapine) PS ORAL 5 MG Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 2839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4332175-7Report Type:Expedited (15-DaCompany Report #JP_040302819 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Zyprexa-Oral Head Banging Health (Olanzapine) Head Injury Professional (Olanzapine) PS 5 MG DAY Subdural Haematoma Company Amoban (Zopiclone) C Representative Lendormin Other (Brotizolam) C Date:03/31/04ISR Number: 4332177-0Report Type:Expedited (15-DaCompany Report #GBS040314610 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Company Representative Other Date:03/31/04ISR Number: 4332179-4Report Type:Expedited (15-DaCompany Report #GBS040314612 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Company Representative Other Date:03/31/04ISR Number: 4332180-0Report Type:Expedited (15-DaCompany Report #FR_040303758 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Other Haldol (Haloperidol) C Lexomil (Bromazepam) C Date:03/31/04ISR Number: 4332182-4Report Type:Expedited (15-DaCompany Report #GBS030913675 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Complications Of Maternal Health (Olanzapine) PS 10 MG/IN THE Exposure To Therapeutic Professional EVENING Drugs Other Folic Acid C 24-Jun-2005 12:19 PM Page: 2840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/04ISR Number: 4333217-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Incompetence Study Risperidone Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL ORAL Phosphokinase Mb Professional Olanzapine Increased (Olanzapine) SS ORAL ORAL Cerebral Atrophy Quetiapine Electrocardiogram Q Waves (Quetiapine) SS ORAL ORAL Fall Ziprasidone Hypertension (Ziprasidone) SS ORAL ORAL Mobility Decreased Perphenazine ( Myoglobin Blood Increased Perphenazine) SS ORAL ORAL Proteinuria Lorazepam Qrs Axis Abnormal (Lorazepam) C Ventricular Extrasystoles Date:04/01/04ISR Number: 4333219-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105361 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Risperdal Consta Corrected Interval Professional (Risperidone) Prolonged Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Electrocardiogram Qt Representative WEEK, Prolonged INTRAMUSCULAR Risperdal (Risperidone) SS ORAL SEE IMAGE ORAL Zyprexa (Olanzapine) Tablets SS ORAL 30 MG, 1 IN 1 DAY,ORAL Prolixin (Fluphenazine Hydrochloride) SS ORAL 2.5 MG, 2 IN 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Date:04/02/04ISR Number: 4331258-5Report Type:Expedited (15-DaCompany Report #FLUV00203001219 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Consumer Luvox (Fluvoxamine Initial or Prolonged Antisocial Behaviour Maleate) PS ORAL 100 MG BID PO Anxiety Fluvoxamine Compulsions (Fluvoxamine) SS ORAL 100 MG BID PO Confusional State Zyprexa (Olanzapine) SS ORAL 5 MG QD PO Depression Effexor (Venlafaxine Drug Intolerance Hydrochloride) C Drug Withdrawal Syndrome Irritability Mania Personality Change Pharmaceutical Product Complaint Suicidal Ideation Weight Increased 24-Jun-2005 12:19 PM Page: 2841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/04ISR Number: 4333903-7Report Type:Expedited (15-DaCompany Report #KII-2001-0000531 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Oxycontin Tablets Myocardial Infarction Professional (Oxycodone Company Hydrochloride) Cr Representative Tablet PS 40 MG, SEE TEXT, UNKNOWN Zyprexa (Olanzapine) SS 2 MG, SEE TEXT, UNKNOWN Xanax (Alprazolam) SS 2 MG, SEE TEXT, UNKNOWN Zoloft (Sertraline Hydrochloride) SS 200 MG, SEE TEXT, UNKNOWN Date:04/05/04ISR Number: 4333631-8Report Type:Direct Company Report #CTU 215960 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Zyprexa 5 Mg Daily PS 5 MG DAILY Intervention to Dilantin 300 Mg Prevent Permanent Daily At Bedtime SS 300 MG DAILY Impairment/Damage AT BEDTIME Date:04/05/04ISR Number: 4334865-9Report Type:Expedited (15-DaCompany Report #DE_031112409 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Pyrexia Health (Olanzapine) Professional (Olanzapine) PS 15 MG/DAY Other Date:04/07/04ISR Number: 4334820-9Report Type:Direct Company Report #CTU 216085 Age: Gender:Male I/FU:I Outcome PT Other Abnormal Faeces Balance Disorder Bradyphrenia Constipation Depressed Level Of Consciousness Disorientation Dizziness Drug Effect Decreased Dry Mouth Dry Throat Fatigue Feeling Abnormal Impaired Driving Ability Memory Impairment Movement Disorder Nasal Discomfort Nasal Dryness Nightmare Rebound Effect 24-Jun-2005 12:19 PM Page: 2842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhinorrhoea Sedation Sneezing Report Source Product Role Manufacturer Route Dose Duration Stupor Olanzapine (Zyprexa) Thirst 10 Mg. [Lilly Code No. 4117 On Tablet] PS Lilly ORAL 5 MG ORAL , ONE DOSE -2.5 MG ORAL TWO DOSES Date:04/07/04ISR Number: 4336228-9Report Type:Expedited (15-DaCompany Report #US_021088722 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Zyprexa-Oral Initial or Prolonged Decreased Literature (Olanzapine) Depressed Level Of Health (Olanzapine) PS 100 MG DAY Consciousness Professional Formication Company Hyperhidrosis Representative Hypoxia Other Intentional Misuse Metabolic Acidosis Muscle Rigidity Rhabdomyolysis Salivary Hypersecretion Social Problem Somnolence Stress Suicide Attempt Tachycardia Tachypnoea Tremor Urinary Incontinence White Blood Cell Count Increased Date:04/07/04ISR Number: 4336229-0Report Type:Expedited (15-DaCompany Report #DE_031012288 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Diet Refusal Health (Olanzapine) Other Drug Interaction Professional (Olanzapine) PS 2.5 MG/3 DAY Hypercoagulation Company Tegretal - Slow International Normalised Representative Release Ratio Increased Other (Carbamazepine) C Pelvic Venous Thrombosis Carbium Prothrombin Time (Carbamazepine) C Prolonged Thyronajod C Jodthyrox C Pantozol (Pantoprazole Sodium) C Marcumar (Phenprocoumon) C Eugulac (Lactulose) C Novalgin (Metamizole Sodium) C 24-Jun-2005 12:19 PM Page: 2843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/04ISR Number: 4336230-7Report Type:Expedited (15-DaCompany Report #EWC040338551 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Zyprexa-Oral Initial or Prolonged Generalised Oedema Health (Olanzapine) Oesophagitis Professional (Olanzapine) PS 20 MG/1 DAY Photophobia Company Tavor (Lorazepam) C Psychotic Disorder Representative Aulin (Nimesulide) C Stevens-Johnson Syndrome Other Tonsillitis Date:04/07/04ISR Number: 4336231-9Report Type:Expedited (15-DaCompany Report #EWC040338330 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine-Oral Health (Olanzapine) PS 15 MG Professional Micardis Company (Telmisartan) C Representative Selektine C Other Metformin C Date:04/07/04ISR Number: 4336246-0Report Type:Expedited (15-DaCompany Report #JP_040302838 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:04/07/04ISR Number: 4336247-2Report Type:Expedited (15-DaCompany Report #JP_040302836 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Zyprexa-Oral Blood Lactate Study (Olanzapine) Dehydrogenase Increased Health (Olanzapine) PS 10 MG/1 DAY Hyperprolactinaemia Professional Pyrethia Lung Neoplasm Malignant Other (Promethazine Hydrochloride) C Epirenat (Valproate Sodium) C Benzalin (Nitrazepam) C Bicamol (Biperiden Hydrochloride) C Pursennid (Senna Leaf) C Bromocriptine Mesilate C Loxonin (Loxoprofen Sodium) C Serenance (Haloperidol) C Lamisil (Terbinafine 24-Jun-2005 12:19 PM Page: 2844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:04/07/04ISR Number: 4336248-4Report Type:Expedited (15-DaCompany Report #JP_040302833 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 10 MG/1 DAY Professional Risperdal Other (Risperidone) C Sepazon (Cloxazolam) C Cercine (Diazepam) C Hirnamin (Levomepromazine) C Pyrethia (Promethazine Hydrochloride) C Date:04/07/04ISR Number: 4336249-6Report Type:Expedited (15-DaCompany Report #GBS040314621 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Olanzapine-Oral Prolonged Health (Olanzapine) PS 5 MG Professional Other Date:04/07/04ISR Number: 4336250-2Report Type:Expedited (15-DaCompany Report #FR_040303812 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 1 DSG FORM/1 Other DAY Theralene (Alimemazine Tartrate) C Anafranil (Clomipramine Hydrochloride) C Depamide (Valpromide) C Rivotril (Clonazepam) C Date:04/07/04ISR Number: 4336251-4Report Type:Expedited (15-DaCompany Report #FR_040303807 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Zyprexa-Oral Initial or Prolonged Convulsion Health (Olanzapine) Hyponatraemia Professional (Olanzapine) PS 15 MG/1 DAY Polydipsia Psychogenic Other Loxapac (Loxapine Succinate) C Neurontin (Gabapentin) C 24-Jun-2005 12:19 PM Page: 2845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gardenal (Phenobarbital) C Date:04/07/04ISR Number: 4336257-5Report Type:Expedited (15-DaCompany Report #JP_040302830 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Literature (Olanzapine) PS Other C-Reactive Protein Health Increased Professional Catatonia Other Disinhibition Excitability Extrapyramidal Disorder Hyperhidrosis Logorrhoea Muscle Rigidity Neuroleptic Malignant Syndrome Psychomotor Hyperactivity Pyrexia Stupor White Blood Cell Count Increased Date:04/07/04ISR Number: 4336258-7Report Type:Expedited (15-DaCompany Report #AU_040307598 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Foreign Zyprexa-Oral Initial or Prolonged Face Oedema Health (Olanzapine0 Oedema Peripheral Professional (Olanzapine) PS 10 MG/1 DAY Pleural Effusion Other Date:04/07/04ISR Number: 4336259-9Report Type:Expedited (15-DaCompany Report #DE-040313273 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) PS Professional Company Representative Other Date:04/07/04ISR Number: 4336260-5Report Type:Expedited (15-DaCompany Report #DE_040313274 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Zyprexa-Oral Hospitalization - Chills Health (Olanzapine) PS 10 MG DAY Initial or Prolonged Rhabdomyolysis Professional Somnolence Other 24-Jun-2005 12:19 PM Page: 2846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/04ISR Number: 4336261-7Report Type:Expedited (15-DaCompany Report #EWC040338564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Zyprexa Initial or Prolonged Health Velotab-Dispersible Professional (Olanzapine) PS 80 MG Other Depakine (Valproate Sodium) C Pyschopax (Diazepam) C Akineton Retard (Biperiden Hydrochloride) C Movicol C Nozinan (Levomepromazine) C Date:04/07/04ISR Number: 4336262-9Report Type:Expedited (15-DaCompany Report #EWC040338585 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Lymphocytic Foreign Zyprexa-Oral Initial or Prolonged Leukaemia Health (Olanzapine) PS 20 MG/1 DAY Asthenia Professional Valium (Diazepam) C Depression Other Lymphadenopathy Date:04/07/04ISR Number: 4336263-0Report Type:Expedited (15-DaCompany Report #FR_040303749 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) PS 10 MG/1 DAY White Blood Cell Count Professional Depakote (Valproate Decreased Other Semisodium) C Luteran (Chlormadinone Acetate) C Date:04/07/04ISR Number: 4336366-0Report Type:Expedited (15-DaCompany Report #USA030742175 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) PS ORAL 20 MG/DAY Body Temperature Topamax Increased (Topiramate) C Date:04/07/04ISR Number: 4336368-4Report Type:Expedited (15-DaCompany Report #USA030741953 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Consumer Zyprexa Other Heart Rate Increased (Olanzapine) PS ORAL Adderall C Trazadone (Trazodone) C Marijuana C 24-Jun-2005 12:19 PM Page: 2847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin (Bupropion Hydrochloride) C Date:04/07/04ISR Number: 4336369-6Report Type:Expedited (15-DaCompany Report #USA030126415 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Paralysis Consumer Zyprexa Other Progressive Multifocal (Olanzapine) PS ORAL Leukoencephalopathy Date:04/07/04ISR Number: 4336370-2Report Type:Expedited (15-DaCompany Report #USA030230066 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Haemorrhage Health Zyprexa Professional Company (Olanzapine) PS ORAL 7.5 MG/DAY Representative Esgic-Plus C Date:04/07/04ISR Number: 4336371-4Report Type:Expedited (15-DaCompany Report #USA030538312 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Zyprexa Initial or Prolonged Confusional State Professional Dehydration (Olanzapine) PS ORAL 5 MG Delirium Vitamin B12 C Haemorrhage Hepatic Function Abnormal Liver Function Test Abnormal Pneumonia Pyrexia Date:04/07/04ISR Number: 4336462-8Report Type:Expedited (15-DaCompany Report #US_0403101761 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:04/07/04ISR Number: 4336463-XReport Type:Expedited (15-DaCompany Report #USA040363087 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Zyprexa-Oral Initial or Prolonged Lung Disorder Professional (Olanzapine) (Olanzapine) PS 5 MG Aricept(Donepezil Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/04ISR Number: 4336465-3Report Type:Expedited (15-DaCompany Report #USA040362933 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Consumer Zyprexa-Oral Initial or Prolonged Grand Mal Convulsion (Olanzapine) Other Head Injury (Olanzapine0 PS 20 MG DAY Rash Generalised Somnolence Date:04/07/04ISR Number: 4336471-9Report Type:Expedited (15-DaCompany Report #USA040362592 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Zyprexa-Oral Confusional State Professional (Olanzapine0 Depression (Olanzapine) PS 5 MG IN THE Somnolence EVENING Date:04/07/04ISR Number: 4336472-0Report Type:Expedited (15-DaCompany Report #USA040362439 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:04/07/04ISR Number: 4336473-2Report Type:Expedited (15-DaCompany Report #USA040363081 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Consumer Zyprexa-Oral Hospitalization - Condition Aggravated (Olanzapine) Initial or Prolonged Dehydration (Olanzapine) PS 30 MG DAY Drug Ineffective Methadone C Faecaloma Clonazepam C Fluid Retention Influenza Mental Disorder Pain Pain In Extremity Pneumonia Sinus Tachycardia Somnolence Staphylococcal Sepsis Urinary Tract Infection Weight Increased Date:04/07/04ISR Number: 4336511-7Report Type:Expedited (15-DaCompany Report #USA040362471 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Humulin - Human Initial or Prolonged Delirium Insulin (Rdna): 30% Hallucination, Visual Regular 70% Nph(H PS 34 U/DAY Mental Disorder Zyprexa - Oral (Olanzapine) SS 2.5 MG/ 1 DAY 24-Jun-2005 12:19 PM Page: 2849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Marplan (Isocarboxazid) C Furosemide C Atenolol C Norvasc (Amlodiine Besialte) C Date:04/07/04ISR Number: 4336554-3Report Type:Expedited (15-DaCompany Report #USA040361534 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Symbyax-Olanzaine Loss Of Consciousness Professional 6mg / Fluoxetine Therapy Non-Responder Company 25mg (Olanzapin PS 1 DSG FORM/1 Representative DAY Strattera (Atomoxetine Hydrochloride) SS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Ortho Tri-Cyclen C Date:04/07/04ISR Number: 4336884-5Report Type:Expedited (15-DaCompany Report #USA030432921 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Necrosis Health Zyprexa-Oral Hepatic Steatosis Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Zoloft (Sertraline Hydrochloride) C Date:04/09/04ISR Number: 4336300-3Report Type:Direct Company Report #CTU 216389 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Olanzapine-Zyprexa PS 5 MG Disability Alopecia (OLANZAPINE) Required Depression Valproic Intervention to Dyspepsia Acid/Depcene/Depakot Prevent Permanent Feelings Of Worthlessness e SS 1000 MG Impairment/Damage Insomnia (DEPAKOTE) Legal Problem Nightmare Paranoia Suicidal Ideation Weight Increased Date:04/12/04ISR Number: 4337495-8Report Type:Direct Company Report #CTU 216441 Age:45 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 2850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Cholelithiasis Zyprexa 25 Mg PS 1 HS Diabetic Hyperosmolar Ativan C Coma Restoril C Pancreatitis Date:04/14/04ISR Number: 4340747-9Report Type:Expedited (15-DaCompany Report #A01200400852 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Foreign Stilnox Hospitalization - Confusional State Health (Zolpidem) PS 20 MG HS Initial or Prolonged Delirium Professional Olanzapine SS 10 MG Restlessness Other Efexor (Venlafaxine Hydrochloride) C Lithium C Date:04/15/04ISR Number: 4339825-XReport Type:Direct Company Report #CTU 216740 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tonic Clonic Movements Olanzapine 10 Mg Tab Intervention to (Lilly) PS Lilly ORAL 10 MG PO BID Prevent Permanent Impairment/Damage Date:04/15/04ISR Number: 4340090-8Report Type:Direct Company Report #CTU 216713 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Decreased Olanzapine 7,5mg Heart Rate Irregular Lilly PS Lilly ORAL 7,5MG DAILY Loss Of Consciousness ORAL Pulse Pressure Decreased Effexor C Syncope Diazepam C Date:04/15/04ISR Number: 4341522-1Report Type:Expedited (15-DaCompany Report #DE_040313274 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Foreign Zyprexa-Oral Hospitalization - Rhabdomyolysis Health (Olanzapine) Initial or Prolonged Somnolence Professional (Olanzapine) PS 10 MG DAY Treatment Noncompliance Company Representative Other Date:04/15/04ISR Number: 4341526-9Report Type:Expedited (15-DaCompany Report #EWC040338551 Age:23 YR Gender:Male I/FU:F Outcome PT Hospitalization - Drug Ineffective Initial or Prolonged General Physical Health Deterioration 24-Jun-2005 12:19 PM Page: 2851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Generalised Oedema Herpes Simplex Serology Positive Report Source Product Role Manufacturer Route Dose Duration Oesophagitis Foreign Zyprexa Photophobia Health Velotab-Dispersible Psychotic Disorder Professional (Olanzapine) Stevens-Johnson Syndrome Company (Olanzapin PS 20 MG DAY Stomatitis Representative Tavor (Lorazepam) C Tonsillitis Other Aulin (Nimesulide) C Virus Serology Test Zithromax Positive (Azithromycin) C Weight Increased Tachifludec C Date:04/15/04ISR Number: 4341532-4Report Type:Expedited (15-DaCompany Report #JP_040202705 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/1 DAY Aminotransferase Company Risperdal Increased Representative (Risperidone) C Blood Albumin Increased Other Wypax (Lorazepam) C Blood Alkaline Tasmolin (Biperiden) C Phosphatase Increased Blood Lactate Dehydrogenase Increased Hepatic Function Abnormal Hepatic Steatosis Hepatomegaly Hyperlipidaemia Protein Total Increased Date:04/15/04ISR Number: 4341650-0Report Type:Expedited (15-DaCompany Report #JP_040302888 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa Oral Completed Suicide Study (Olanzapine)(Olanzap Constipation Health ine) PS 7.5 MG DAY Insomnia Professional Risperdal Multiple Drug Overdose Other (Risperidone) C Paraesthesia Hirnamin Persecutory Delusion (Levomepromazine) C Doral (Quazepam) C Gasmotin (Mosapride Citrate) C Sennoside A C Levotomin (Levomepromazine Maleate) C Date:04/15/04ISR Number: 4341663-9Report Type:Expedited (15-DaCompany Report #EWC040338684 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Vaginal Haemorrhage Foreign Health 24-Jun-2005 12:19 PM Page: 2852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Olanzapine Oral (Olanzapine) PS 5 MG/1 DAY Clopixol (Zuclopenthixol Decanoate) C Date:04/15/04ISR Number: 4341668-8Report Type:Expedited (15-DaCompany Report #JP_040402902 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa Oral Refusal Of Treatment By Health (Olanzapine)(Olanzap Patient Professional ine) PS Company Representative Other Date:04/15/04ISR Number: 4341670-6Report Type:Expedited (15-DaCompany Report #EWC040338662 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Olanzapine-Oral Health (Olanzapine) PS 2.5 MG DAY Professional Furosemide C Other Captopril C Citalopram C Ferrosi Fumaras C Flurazepam C Homeopathic Agent C Risperdal (Risperidone) C Date:04/15/04ISR Number: 4341675-5Report Type:Expedited (15-DaCompany Report #CA_040306711 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Foreign Zyprexa-Oral Initial or Prolonged Retinal Haemorrhage Consumer (Olanzapine) Other Health (Olanzapine) PS 2.5 MG DAY Professional Other Date:04/15/04ISR Number: 4341685-8Report Type:Expedited (15-DaCompany Report #DE_040413352 Age:78 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abasia Initial or Prolonged Activities Of Daily Disability Living Impaired Brain Stem Ischaemia Cerebral Atrophy Condition Aggravated Dementia Dysstasia 24-Jun-2005 12:19 PM Page: 2853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report General Physical Condition Abnormal Iiird Nerve Paresis Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Foreign Zyprexa-Oral Nervous System Disorder Health (Olanzapine) Paraparesis Professional (Olanzapine) PS 5 MG DAY Speech Disorder Other Pipamperone C Haloperidol C Clomethiazole C Chlorprothixene C Lorazepam C Furorese (Furosemide) C Kalinor (Potassium Chloride) C Calcium C Date:04/15/04ISR Number: 4341694-9Report Type:Expedited (15-DaCompany Report #EWC040338661 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mania Foreign Zyprex-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Other Eltroxin (Levothyroxine Sodium) C Lithium Carbonate C Date:04/15/04ISR Number: 4341851-1Report Type:Expedited (15-DaCompany Report #USA040363556 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Hypertension Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 7.5 MG Representative Carbamazepine C Citalopram C Aricept (Donepezil Hydrochloride) C Bupropion C Albuterol C Digoxin C Aerobid (Flunisolide) C Foradil (Formoterol Fumarate) C Hydrochlorothiazide C Prilosec (Omeprazole) C Metoprolol C Atrovent (Ipratropium Bromide) C Flomax (Morniflumate) C Simvastatin C Ambien (Zolpidem Tartrate) C 24-Jun-2005 12:19 PM Page: 2854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Procrit C Date:04/15/04ISR Number: 4341852-3Report Type:Expedited (15-DaCompany Report #USA040363580 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 20 MG DAY Representative Date:04/15/04ISR Number: 4341853-5Report Type:Expedited (15-DaCompany Report #USA040463726 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Agitation (Olanzapine) Antisocial Behaviour (Olanzapine) PS Confusional State Lithium C Sudden Onset Of Sleep Weight Increased Date:04/15/04ISR Number: 4341857-2Report Type:Expedited (15-DaCompany Report #USA040463754 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa-Oral Drug Level Increased Professional (Olanzapine) Fatigue (Olanzapine) PS 20 MG DAY Major Depression Oral Intake Reduced Weight Decreased Date:04/15/04ISR Number: 4341858-4Report Type:Expedited (15-DaCompany Report #US_0402100535 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Zyprexa-Oral Breast Cancer Female (Olanzapine) Depression (Olanzapine) PS Drug Ineffective Prozac-Oral Dyspnoea (Fluoxetine) Food Craving (Fluoxetine Hypertension Hydrochloride) SS Increased Appetite Lexapro Pain (Escitalopram) C Renal Disorder Topamax (Topiramate) C Tinnitus Lorazepam C Weight Increased Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4341862-6Report Type:Expedited (15-DaCompany Report #USA040463721 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Symbyax-Olanzapine Initial or Prolonged Professional 12 Mg / Fluoxetine Company 50 Mg (Olanzapin) PS 2 DEG FORM/1 Representative DAY Date:04/15/04ISR Number: 4341875-4Report Type:Expedited (15-DaCompany Report #USA030741527 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Depakote C Date:04/15/04ISR Number: 4341877-8Report Type:Expedited (15-DaCompany Report #USA040363234 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Health Zyprexa-Oral Obesity Professional (Olanzapine) Pancreatitis (Olanzapine) PS 20 MG Renal Disorder Lithium C Depakote (Valproate Semisodium) C Tegretol (Carbamazepine) C Date:04/15/04ISR Number: 4341878-XReport Type:Expedited (15-DaCompany Report #USA040363246 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Akathisia (Olanzapine) Drug Ineffective (Olanzapine) PS 5 MG DAY 4 MON Dysphonia Strattera Sydenham'S Chorea (Atomoxetine Tardive Dyskinesia Hydrochloride) SS 40 MG DAY Vocal Cord Disorder Risperdal (Risperidone) C Depakote (Alproate Semisodium) C Klonopin (Clonazepam) C Date:04/15/04ISR Number: 4341879-1Report Type:Expedited (15-DaCompany Report #USA040363335 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa-Oral Initial or Prolonged Treatment Noncompliance Professional (Olanzapine) (Olanzapine) PS 45 MG DAY Depakoate (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4341881-XReport Type:Expedited (15-DaCompany Report #USA040363451 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bladder Cancer Consumer Zyprexa-Oral Dependence (Olanzapine) Diabetes Mellitus (Olanzapine) PS 30 MG DAY Enuresis Prozac-Oral Post Procedural (Fluoxetine) Complication (Fluoxetine Sleep Apnoea Syndrome Hydrochloride) SS 40 MG DAY Weight Increased Tofranil (Imipramine Hydrochloride) C Prevacid (Lansoprazole) C Phenergan (Promethazine Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Date:04/15/04ISR Number: 4341882-1Report Type:Expedited (15-DaCompany Report #USA040363554 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 15 MG AT BEDTIME Albuterol C Ipratropium C Alprazolam C Fosamax (Alendronate Sodium) C Clonazepam C Depakote (Valproate Semisodium) C Estratest C Folic Acid C Stool Softener (Docusate Sodium) C Foradil (Formoterol Fumarate) C Synthroid (Levothyroxine Sodium) C Hypothyroid C Cytomel (Liothyronine Sodium) C Ativan (Lorazepam) C Morphine Sulfate C Prednisone C Sonatat (Zoleplon) C Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 2857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4341918-8Report Type:Expedited (15-DaCompany Report #USA030946664 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Zyprexa-Oral Initial or Prolonged Asthenia (Olanzapine) Other Atelectasis (Olanzapine) PS FOR A FEW Chest Pain MONTHS Pain In Extremity Pleural Effusion Syncope Date:04/15/04ISR Number: 4341922-XReport Type:Expedited (15-DaCompany Report #US_031199068 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Headache Consumer Zyprexa-Oral Metabolic Disorder Health (Olanzapine) Pancreatitis Haemorrhagic Professional (Olanzapine) PS 15 MG/DAY Refusal Of Treatment By Seroquel (Quetiapine Patient Fumarate) C Urinary Tract Infection Activan (Lorazepam) C Vistaril (Hydroxyzine Embonate) C Depo Provera (Medroxyprogesterone Acetate) C Septra C Ambien(Zolpidem Tartrate) C Date:04/15/04ISR Number: 4341924-3Report Type:Expedited (15-DaCompany Report #USA040258187 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa-Oral Initial or Prolonged Pleural Effusion Professional (Olanzapine) Other Pneumonia Company (Olanzapine) PS 20 MG/2 DAY Refusal Of Treatment By Representative Depakote (Valproate Patient Semisodium) C Combivent C Cozaar (Losartan Potassium) C Norvasc (Amlodipine Besilate) C Zantac (Ranitidine Hydrochloride) C Date:04/15/04ISR Number: 4342014-6Report Type:Expedited (15-DaCompany Report #USA030126592 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4342235-2Report Type:Expedited (15-DaCompany Report #EWC040438731 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa-Rapid-Acting Hospitalization - Cardiac Disorder Health Im (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Professional Dehydrobenzperidol Company (Droperidol) C Representative Date:04/15/04ISR Number: 4342236-4Report Type:Expedited (15-DaCompany Report #EWC040438734 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Olanzapine-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) PS 20 MG DAY Condition Aggravated Professional Melleril Psychotic Disorder Other (Thioridazine Pyrexia Hydrochloride) C Sinusitis Temesta (Lorazepam) C Dalmadorm (Flurazepam Hydrochloride) C Date:04/15/04ISR Number: 4342237-6Report Type:Expedited (15-DaCompany Report #FR_040303830 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 30 MG/1 OTHER Company Diuretic C Representative Haldol (Haloperidol) C Other Tercian (Cyamemazine) C Unspecified Neuroleptic C Date:04/15/04ISR Number: 4342238-8Report Type:Expedited (15-DaCompany Report #FR_040403838 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Head Injury Foreign Zyprexa-Oral Lung Disorder Health (Olanzapine) Pulmonary Oedema Professional (Olanzapine) PS 20 MG/1 DAY Refusal Of Treatment By Company Zyprexa-Oral Patient Representative (Olanzapine) Suicide Attempt Other (Olanzapine) SS OTHER 10 MG/1 OTHER Leponex (Clozapine) C Date:04/15/04ISR Number: 4342239-XReport Type:Expedited (15-DaCompany Report #JP_040302878 Age:66 YR Gender:Female I/FU:I Outcome PT Disability Depression Idiopathic Thrombocytopenic Purpura Refusal Of Treatment By 24-Jun-2005 12:19 PM Page: 2859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Patient Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG DAY Company Toledomin Representative (Milnacipran Other Hydrochloride) C Depas (Etizolam) C Date:04/16/04ISR Number: 4340130-6Report Type:Direct Company Report #CTU 216753 E Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Olanzapine PS ORAL PO ORAL Hospitalization - Hyperreflexia Initial or Prolonged Mental Status Changes Required Neuroleptic Malignant Intervention to Syndrome Prevent Permanent Impairment/Damage Date:04/19/04ISR Number: 4340836-9Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0493269A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Eskalith PS Glaxosmithkline ORAL 225MG Per day 23 YR Increased Lamictal SS Glaxosmithkline ORAL 125MG per day 2 MON Confusional State Zyprexa SS Dizziness Valium C Erectile Dysfunction Seizure Medication C UNKNOWN Extrapyramidal Disorder Gabapentin C Fatigue Gabatril C Insomnia Renal Disorder Sexual Dysfunction Date:04/19/04ISR Number: 4343638-2Report Type:Expedited (15-DaCompany Report #2003035058 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Albumin Globulin Ratio Initial or Prolonged Decreased Disability Anaemia Other Arthralgia Bronchitis Drug Hypersensitivity Dry Skin Excoriation Eye Pain Headache Herpes Simplex Leukocytoclastic Vasculitis Neutrophil Count Decreased Onychomadesis 24-Jun-2005 12:19 PM Page: 2860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Photosensitivity Reaction Protein Total Decreased Respiratory Tract Report Source Product Role Manufacturer Route Dose Duration Congestion Consumer Zithromax (Caps) Skin Lesion (Azithromycin) PS ORAL DAILY, ORAL Skin Ulcer Carbamazepine Stevens-Johnson Syndrome (Carbamazepine) SS ORAL 400 MG (BID), Toxic Epidermal ORAL Necrolysis Olanzapine Urticaria (Olanzapine) SS ORAL 5 MG (DAILY), ORAL Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:04/20/04ISR Number: 4345978-XReport Type:Expedited (15-DaCompany Report #FRWYE695207APR04 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Effexor Lp Initial or Prolonged Mania Professional (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL 37.5 MG 2X PER 1 DAY 2 YR Cannabis (Cannabis) SS Zyprexa (Olanzapine) SS ORAL LOW DOSE Date:04/21/04ISR Number: 4343105-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0502021A Age:9 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Paxil PS Glaxosmithkline ORAL 20MG Unknown 8 MON Initial or Prolonged Aggression Zoloft SS ORAL 50MG Unknown Anger Zyprexa SS 10MG Unknown Arrhythmia Myalgia Pain In Extremity Self Mutilation Suicidal Ideation Suicide Attempt Date:04/22/04ISR Number: 4347097-5Report Type:Expedited (15-DaCompany Report #USA040464193 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Mass Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 25 MG/DAY Representative 24-Jun-2005 12:19 PM Page: 2861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4347098-7Report Type:Expedited (15-DaCompany Report #USA040464200 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Uterine Neoplasm Consumer Zyprexa-Oral Initial or Prolonged Body Height Decreased (Olanzapine) Other Fatigue (Olanzapine) PS 10 MG/1 DAY Increased Appetite Lithium C Mania Zoloft (Sertraline Somnolence Hydrochloride) C Weight Increased Vistaril (Hydroxyzine Embonate) C Estradiol C Date:04/22/04ISR Number: 4347100-2Report Type:Expedited (15-DaCompany Report #USA040464024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa -Oral Initial or Prolonged Professional (Oanlzapine) Company (Olanzapine) PS 30 MG DAY Representative Date:04/22/04ISR Number: 4347189-0Report Type:Expedited (15-DaCompany Report #US_010360854 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Olanzapine-Oral First Degree Literature (Olanzapine) PS 10 MG/1 DAY 1 DAY Condition Aggravated Health Perphenazine C Drug Ineffective Professional Electrocardiogram Qt Other Prolonged Hypotension Hypothermia Loss Of Consciousness Psychotic Disorder Somnolence Date:04/22/04ISR Number: 4347357-8Report Type:Expedited (15-DaCompany Report #JP_040302888 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa-Oral Constipation Study (Olanzapine) Insomnia Health (Olanzapine) PS 7.5 MG DAY Paraesthesia Professional Risperdal Persecutory Delusion Other (Risperidone) C Hirnamin (Levomepromazine) C Doral (Quazepam) C Gasmotin (Mosapride Citrate) C Levotomin (Levomepromazine Maleate) C 24-Jun-2005 12:19 PM Page: 2862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4347358-XReport Type:Expedited (15-DaCompany Report #FR_040403838 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Head Injury Foreign Zyprexa-Oral Pneumonia Aspiration Health (Olanzapine) Pulmonary Oedema Professional (Olanzapine) PS 20 MG/1 DAY Refusal Of Treatment By Company Zyprexa-Rapid-Acting Patient Representative Im(Olanzapine) SS 10 MG/1 OTHER Suicide Attempt Other Leponex (Clozapine) C Date:04/22/04ISR Number: 4347486-9Report Type:Expedited (15-DaCompany Report #USA-2004-0014543 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Atherosclerosis Health Oxycodone Hepatic Cirrhosis Professional Hydrochloride Hepatitis C Other (Similar To Nda Multiple Drug Overdose 20-553) (Oxycodone Pulmonary Oedema Hydrochloride) PS Ethanol (Ethanol) SS Diazepam (Diazepam) SS Temazepam (Temazepam) SS Gabapentin (Gabapentin) SS Citalopram (Citalopram) SS Olanzapine (Olanzapine) SS Oxazepam (Oxazepam) SS Date:04/22/04ISR Number: 4347591-7Report Type:Expedited (15-DaCompany Report #US_0404102049 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Literature Olanzapine-Oral Initial or Prolonged Blood Potassium Increased Health (Olanzapine) PS 11.25 MG DAY Other Blood Thyroid Stimulating Professional Divalproex Sodium C Hormone Increased Glipizide C Hypothermia Furosemide C Atorvastatin C Lisinopril C Ferrous Sulfate C Docusate Sodium C Senna C Pilocarpine C Date:04/22/04ISR Number: 4347600-5Report Type:Expedited (15-DaCompany Report #USA040464142 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Symbyax-Olanzapine / Professional Fluoxetine (Unknown Company Dose) (Ola PS 4 DAY Representative 24-Jun-2005 12:19 PM Page: 2863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4347634-0Report Type:Expedited (15-DaCompany Report #USA040463859 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Prozac-Oral Boredom (Fluoxetine) Cartilage Injury (Fluoxetine Depression Hydrochloride) PS 20 MG/3 DAY Disturbance In Attention Zyprexa-Oral Mental Disorder (Olanzapine) (Olanzapine) SS 2.5 MG/1 DAY Vicodin C Date:04/22/04ISR Number: 4347678-9Report Type:Expedited (15-DaCompany Report #US_0404102096 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Damage Consumer Zyprexa-Oral Disability Extrapyramidal Disorder (Olanzapine) Neuroleptic Malignant (Olanzapine) PS Syndrome Tardive Dyskinesia Date:04/22/04ISR Number: 4347697-2Report Type:Expedited (15-DaCompany Report #USA030742432 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Date:04/22/04ISR Number: 4347753-9Report Type:Expedited (15-DaCompany Report #USA030434452 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Zyprexa-Oral Hospitalization - Distress Syndrome Professional (Olanzapine) Initial or Prolonged Rhabdomyolysis Company (Olanzapine) PS Other Viral Myocarditis Representative Date:04/22/04ISR Number: 4347764-3Report Type:Expedited (15-DaCompany Report #USA030434903 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Anger (Olanzapine) Other Bladder Cancer (Olanzapine) PS Dry Mouth Morphine C Impulse-Control Disorder Prostatectomy Screaming Speech Disorder 24-Jun-2005 12:19 PM Page: 2864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4347851-XReport Type:Expedited (15-DaCompany Report #USA040155894 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Zyprexa-Oral Anorexia (Olanzapine) Blood Pressure Abnormal (Olanzapine) PS 2 WK Capillary Disorder Strattera Dizziness (Atomoxetine Erythema Hydrochloride) SS 60 MG DAY Feeling Cold Depakote (Valproate Homicidal Ideation Semisodium) C Hypertension Tegretal Hypoventilation (Carbamazepine) C Myocardial Infarction Pulse Absent Skin Discolouration Tachycardia Date:04/22/04ISR Number: 4347858-2Report Type:Expedited (15-DaCompany Report #US_0403101537 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Alanine Aminotransferase Health (Olanzapine) Increased Professional (Olanzapine) PS 40 MG DAY Alcoholism Other Trazodone C Aspartate Aminotransferase Increased Blood Cholesterol Increased Blood Creatine Phosphokinase Increased Blood Triglycerides Increased Coordination Abnormal Drug Dependence Drug Ineffective Gamma-Glutamyltransferase Increased Insomnia Intention Tremor Medication Error Mental Status Changes Psychotic Disorder Date:04/22/04ISR Number: 4347861-2Report Type:Expedited (15-DaCompany Report #USA040463726 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Consumer Zyprexa-Oral Hospitalization - Aggression (Olanzapine) Initial or Prolonged Agitation (Olanzapine) PS Other Confusional State Lithium C Myocardial Infarction Sleep Attacks Weight Increased 24-Jun-2005 12:19 PM Page: 2865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4347864-8Report Type:Expedited (15-DaCompany Report #USA030332633 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Zyprexa-Oral Other Overdose Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Norvasc (Amlodipine Besilate) C Aldactazide C Date:04/22/04ISR Number: 4347866-1Report Type:Expedited (15-DaCompany Report #US_991029297 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Literature Zyprexa-Oral Initial or Prolonged Aminotransferase Health (Olanzapine) Other Increased Professional (Olanzapine) PS 5 MG/1 DAY Blood Pressure Diastolic Bactrim C Decreased Lithium C Coma Trazodone C Constipation Piroxicam C Decreased Activity Clonazepam C Depressed Level Of Lactulose C Consciousness Trimethorpim C Drug Interaction Drug Level Increased Hypothermia Lethargy Mental Status Changes Muscle Rigidity Oral Intake Reduced Pitting Oedema Social Avoidant Behaviour Date:04/22/04ISR Number: 4348039-9Report Type:Expedited (15-DaCompany Report #USA040463721 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Symbyax-Olanzapine Initial or Prolonged Professional 12mg / Fluoxeint Company 50mg (Olanzapi PS 2 DSG FORM/1 Representative DAY Date:04/22/04ISR Number: 4348230-1Report Type:Expedited (15-DaCompany Report #JP_040202677 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Study (Olanzapine) Hepatic Function Abnormal Health (Olanzapine) PS Influenza Professional Serenace Other (Haloperidol) C Ciproxan (Ciprofloxacin Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4348231-3Report Type:Expedited (15-DaCompany Report #US-980910821 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Foreign Zyprexa-Oral Confusional State Literature (Olanzapine) PS 1 DAY Hypothermia Health Risperidone C Secondary Adrenocortical Professional Insufficiency Other Date:04/22/04ISR Number: 4348439-7Report Type:Expedited (15-DaCompany Report #FR_040403886 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Date:04/22/04ISR Number: 4348451-8Report Type:Expedited (15-DaCompany Report #FR_040403893 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Zyprexa-Rapid-Acting Initial or Prolonged Anaemia Health Im (Olanzapine) PS 10 MG/1 DAY Thrombocytopenia Professional Neuleptil Other (Periciazine) C Depamide (Valpromide) C Date:04/22/04ISR Number: 4348453-1Report Type:Expedited (15-DaCompany Report #DE_040413354 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Foreign Zyprexa-Oral Gynaecomastia Consumer (Olanzapine)(Olanzap Nephrolithiasis Other ine) PS 7.5 MG DAY 5 YR Weight Increased Tavor (Lorazepam) C Date:04/22/04ISR Number: 4348455-5Report Type:Expedited (15-DaCompany Report #EWC040438790 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa-Oral Initial or Prolonged Head Injury Health (Olanzapine) Loss Of Consciousness Professional (Olanzapine) PS 5 MG DAY Transient Ischaemic Other Depakin Chrono Attack (Valproate Sodium) C Date:04/22/04ISR Number: 4348562-7Report Type:Expedited (15-DaCompany Report #JP_040402942 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Death Completed Suicide Foreign Study Health Professional 24-Jun-2005 12:19 PM Page: 2867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 2.5 MG DAY Date:04/22/04ISR Number: 4348563-9Report Type:Expedited (15-DaCompany Report #JP_040402945 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Foreign Zyprexa- Oral Initial or Prolonged Health (Olanzapine) PS 15 MG DAY Professional Benzalin Company (Nitrazepam) C Representative Sennoside A+B C Other Date:04/22/04ISR Number: 4348564-0Report Type:Expedited (15-DaCompany Report #JP_040402946 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zyprexa-Oral Hospitalization - Depression Study (Olanzapine) PS 10 MG DAY Initial or Prolonged Drug Toxicity Health Akineton (Biperiden Fatigue Professional Hydrochloride) C Hyperglycaemia Other Mercazole Insomnia (Thiamazole) C Overdose Red Blood Cell Count Increased Suicidal Ideation Suicide Attempt Date:04/22/04ISR Number: 4348565-2Report Type:Expedited (15-DaCompany Report #GBS040414695 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Zyprexa-Oral Other Drug Toxicity Health (Olanzapine) PS 25 MG DAY Professional Morphine C Company Stelazine Representative (Trifluoperazine Other Hydrochloride) C Date:04/22/04ISR Number: 4348567-6Report Type:Expedited (15-DaCompany Report #GBS040414697 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Foreign Zyprexa-Dispersible Hospitalization - Cardiac Disorder Health (Olanzapine) PS 15 MG DAY Initial or Prolonged Circulatory Collapse Professional Other Drug Level Increased Company Drug Toxicity Representative Other 24-Jun-2005 12:19 PM Page: 2868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/04ISR Number: 4347346-3Report Type:Direct Company Report #CTU 217366E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Symbyax 12.25 Mg PS ORAL 1 DAILY ORAL Initial or Prolonged Drug Interaction Lithium Carbonate C Required Drug Withdrawal Syndrome Furosemide C Intervention to Memory Impairment Kcl C Prevent Permanent Self Injurious Behaviour Mvi C Impairment/Damage Suicidal Ideation Vitamin E C Date:04/28/04ISR Number: 4349363-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01567 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Leponex / Clozaril Initial or Prolonged Consciousness (Clozapine) PS Novartis Sector: Drug Interaction Pharma ORAL 12.5 mg/day 1440 MIN Facial Bones Fracture Leponex / Clozaril Fall (Clozapine) SS Novartis Sector: Grand Mal Convulsion Pharma ORAL 25 mg/day 1440 MIN Risperdal SS 1 to 3 mg/day 5760 MIN Risperdal SS 4 mg/day 108 DAY Risperdal SS 5 mg/day 17280MIN Risperdal SS 6 mg/day Zyprexa SS 5 to 10 mg/day 28800MIN Zyprexa SS 15 mg/day 51840MIN Zyprexa SS 20 mg/day 83 DAY Zyprexa SS 10 mg/day Cipramil SS 20 mg/day 56160MIN Bronchoretard SS 350 mg/day Tavor C 3 to 4 mg/day 44640MIN Tavor C 2.5 to 0.5 mg/day 73440MIN Tavor C 2 to 1.5 mg/day 79200MIN Tavor C 1 mg/day 34560MIN Tavor C 0.5 mg/day 4320 MIN Ass "Hexal" C 100 mg/day Pulmicort C 0.8 mg/day Berotec C 0.4 mg/day Date:04/28/04ISR Number: 4349965-7Report Type:Direct Company Report #CTU 217617 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Zyprexa 10 Mg -Lilly PS Lilly ORAL Q HS (ORALLY) Oropharyngeal Swelling Fluoxetine C Swelling Face Nicorette Gum C Nabumetone C Acetaminophen C Seroquel C Lorazepam C Hydroxyzine Pamoate C Maalox C Milk Of Magnesia C 24-Jun-2005 12:19 PM Page: 2869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/04ISR Number: 4351235-8Report Type:Expedited (15-DaCompany Report #US_0402100535 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Zyprexa-Oral Activities Of Daily (Olanzapine) Living Impaired (Olanzapine) PS Blood Pressure Increased Prozac-Oral Breast Cancer (Fluoxetine) Depression (Fluoxetine Drug Ineffective Hydrochloride) SS Dyspnoea Lexapro Emotional Distress (Escitalopram) C Food Craving Topamax (Topiramate) C Hypertension Lorazepam C Increased Appetite Depakote (Valproate Pain Semisodium) C Renal Disorder Self Esteem Decreased Sensation Of Pressure Tinnitus Weight Increased Date:04/28/04ISR Number: 4351244-9Report Type:Expedited (15-DaCompany Report #USA040259216 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Prozac-Oral Hospitalization - Weight Increased Professional (Fluoxetine) Initial or Prolonged Company (Fluoxetine Representative Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Seroquel (Quetiapine Fumarate) C Date:04/28/04ISR Number: 4351247-4Report Type:Expedited (15-DaCompany Report #USA040464215 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Application Site Vesicles (Olanzapine) Blood Glucose Increased (Olanzapine) PS 10 MG Feeling Hot Concerta Food Craving (Methylphenidate Hallucination, Auditory Hydrochloride) C Increased Appetite Clonidine C Mania Rital In La Physical Assault (Methylphenidate Pollakiuria Hydrochloride) C Polydipsia Weight Increased 24-Jun-2005 12:19 PM Page: 2870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/04ISR Number: 4351312-1Report Type:Expedited (15-DaCompany Report #USA040361626 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Increased Consumer Forteo Bone Density Decreased (Teriparatide) PS Hip Arthroplasty Zyprexa-Oral Knee Arthroplasty (Olanzapine) Skin Disorder (Olanzapine) SS 5 MG Lactulose C Celebrex C Folic Acid C Lisinopril C Hydrochlorothiazide C Synthroid (Levothyroxine Sodium) C Allopurinol C Ditropan (Oxybutynin) C Xanax (Alprazolam) C Milk Of Magnesia C Coumadin (Warfarin Sodium) C Remeron (Mirtazapine) C Effexor (Venlafaxine Hydrochloride) C Date:04/28/04ISR Number: 4351328-5Report Type:Expedited (15-DaCompany Report #USA030638693 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa-Oral Hospitalization - Ammonia Increased Professional (Olanzapine) Initial or Prolonged Hepatic Failure Company (Olazapine) PS 2.5 MG/DAY Liver Disorder Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG DAY Vicodin C Date:04/28/04ISR Number: 4351410-2Report Type:Expedited (15-DaCompany Report #USA040464803 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Symbyax-Olanzapine / Initial or Prolonged Professional Fluoxetine (Unknown Company Dose) (Ola PS Representative Date:04/28/04ISR Number: 4351411-4Report Type:Expedited (15-DaCompany Report #USA040464524 Age:33 YR Gender:Female I/FU:I Outcome PT Hospitalization - Burning Sensation Initial or Prolonged Convulsion Depressed Level Of Consciousness 24-Jun-2005 12:19 PM Page: 2871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Spasms Paraesthesia Restless Legs Syndrome Report Source Product Role Manufacturer Route Dose Duration Tremor Consumer Symbyax-Olanzapine 6 Mg / Fluoxetine 25 Mg (Olanzapin PS 1 DSG FORM/1 AT BEDTIME Reglan (Metoclopramide) C Nexium (Esomeprazole) C Nystatin C Robitussin (Guaifenesin) C Pseudoephedrine C Advair C Date:04/28/04ISR Number: 4351413-8Report Type:Expedited (15-DaCompany Report #USA040464492 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Symbyax-Olanzapine 6 Initial or Prolonged Oedema Peripheral Professional Mg / Fluoxetine 25 Other Company Mg (Olanzapin PS 1DSG FORM/1 Representative DAY Celexa (Citalopram Hydrobromide) C Date:04/28/04ISR Number: 4351511-9Report Type:Expedited (15-DaCompany Report #USA040464354 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa Circulatory Collapse Professional Zydis-Dispersible Coronary Artery Stenosis (Olazapine) Drug Level Increased (Olanzapine) PS 10 MG DAY Capoten (Captopril) C Lexapro (Escitalopram) C Date:04/28/04ISR Number: 4351512-0Report Type:Expedited (15-DaCompany Report #USA040463975 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Health Zyprexa-Oral Initial or Prolonged Osteomyelitis Professional (Olanzapine) Vaginal Pain Company (Olanzapine) PS 20 MG DAY Representative Nafcilline C Lexapro (Escitalopram) C Date:04/28/04ISR Number: 4351514-4Report Type:Expedited (15-DaCompany Report #USA040363244 Age: Gender:Female I/FU:I Outcome PT Life-Threatening Asthenia Other Cerebral Thrombosis 24-Jun-2005 12:19 PM Page: 2872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Appetite Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 7.5 MG/DAY Lexapro (Escitalopram) C Digoxin C Protonix (Pantoprazole) C Lorazepam C Valium (Diazepam) C Date:04/28/04ISR Number: 4352186-5Report Type:Expedited (15-DaCompany Report #GBS040414726 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menorrhagia Foreign Olanzapine-Oral Oedema Peripheral Health (Olanzapine) PS ORAL 10 MG Weight Increased Professional Other Date:04/28/04ISR Number: 4352194-4Report Type:Expedited (15-DaCompany Report #JP_040202589 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Study (Olanzapine) Other Blood Creatine Health (Olanzapine) PS 10 MG/1 DAY Phosphokinase Increased Professional Tasmolin (Biperiden) C Enteritis Infectious Other Rohypnol Gamma-Glutamyltransferase (Flunitrazepam) C Increased Neo F Lase C Gastric Ulcer Seroquel (Quetiapine Haemorrhoids Fumarate) C Ileus Nitrazepam C Nasopharyngitis Contomin Urinary Retention (Chlorpromazine Hydrochloride) C Magnesium Oxide C Vegetamin B C Levotomin (Levomepromazine Maleate) C Serenace (Haloperidol) C Amoban (Zopiclone) C Prolmon (Protoporphyrin Disodium) C Date:04/28/04ISR Number: 4352195-6Report Type:Expedited (15-DaCompany Report #JP_040302833 Age:37 YR Gender:Male I/FU:F Outcome PT Death Completed Suicide Condition Aggravated 24-Jun-2005 12:19 PM Page: 2873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Family Stress Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 10 MG/1 DAY Professional Risperdal Other (Risperidone) C Sepazon (Cloxazolam) C Cercine (Diazepam) C Hirnamin (Levomepromazine) C Pyrethia (Promethazine Hydrochloride) C Date:04/28/04ISR Number: 4352196-8Report Type:Expedited (15-DaCompany Report #JP_040402945 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Eruption Foreign Zyprexa-Oral Pruritus Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Company Benzalin Representative (Nitrazepam) C Other Sennoside A+B C Date:04/28/04ISR Number: 4352197-XReport Type:Expedited (15-DaCompany Report #DE_040313273 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS UNKNOWN UNK Company Representative Other Date:04/28/04ISR Number: 4352288-3Report Type:Expedited (15-DaCompany Report #JP_040402971 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Zyprexa-Oral Blood Creatinine Health (Olanzapine) PS 10 MG DAY Increased Professional Linton (Haloperidol) C Blood Urea Increased Company Neuleptil Malaise Representative (Pericizine) C Mydriasis Levomepromazine C Refusal Of Treatment By Depas (Etiozolam) C Patient Rohipnol (Flunitrazepam) C Thyradin S (Levothyroxine Sodium) C Calslot (Manidipine Hydrochloride) C Diovan (Valsartan) C Lexin 24-Jun-2005 12:19 PM Page: 2874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Carbamazepine) C Artane (Trihexyphenidyl Hydrochloride) C Forsenid (Sennoside A+B) C Date:04/28/04ISR Number: 4352289-5Report Type:Expedited (15-DaCompany Report #GBS040414761 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Zyprexa-Oral Health (Olanzapine) PS Professional Company Representative Date:04/28/04ISR Number: 4352291-3Report Type:Expedited (15-DaCompany Report #FR_040403927 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) PS Professional Company Representative Date:04/28/04ISR Number: 4352294-9Report Type:Expedited (15-DaCompany Report #FR_040403926 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) PS Professional Company Representative Other Date:04/28/04ISR Number: 4352303-7Report Type:Expedited (15-DaCompany Report #EWC040438853 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apallic Syndrome Foreign Zyprexa-Oral Asthenia Health (Olanzapine) PS 2.5 MG/1 DAY Brain Oedema Professional Atenolol C Bundle Branch Block Left Other Enalapril C Cardio-Respiratory Arrest Indapamide C Coma Bromazepam C Confusional State Dorzolamide C Hallucination Timolol C Hypercapnia Brimonidine C Hypoxia Voltaren (Diclofenac Quadriplegia Sodium) C Respiratory Failure Tremor 24-Jun-2005 12:19 PM Page: 2875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/04ISR Number: 4352306-2Report Type:Expedited (15-DaCompany Report #EWC040438828 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Zyprexa-Oral Initial or Prolonged Coma Health (Olanzapine) PS 10 MG/2 DAY Dystonia Professional Methadone C Extrapyramidal Disorder Muscle Rigidity Overdose Parkinson'S Disease Suicide Attempt Treatment Noncompliance Date:04/28/04ISR Number: 4352331-1Report Type:Expedited (15-DaCompany Report #FR_040403924 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:04/30/04ISR Number: 4353812-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040404516 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Facial Bones Fracture Health (Risperidone) Fall Professional Unspecified PS 1-3 MG/DAY; 4 Grand Mal Convulsion MG; 5 MG; 6 MG Leponex (Clozapine) SS 12.5 MG; 25 MG Zyprexa (Olanzapine) SS 5-10 M G Cipramil (Citalopram Hydrobromide) SS 20 MG Bronchoretard (Theophylline) SS 350 MG Ass (Unknown) (Acetylsalicylic Acid C Pulmicort (Unknown) Budesonide C Date:05/04/04ISR Number: 4355189-XReport Type:Expedited (15-DaCompany Report #2004013789 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS 160 Confusional State Professional Olanzapine Disorientation Company (Olanzapine) SS Psychotic Disorder Representative Weight Increased 24-Jun-2005 12:19 PM Page: 2876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/04ISR Number: 4353558-5Report Type:Expedited (15-DaCompany Report #INV0229 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Eskalith PS Glaxosmithkline ORAL 225MG Per day 23 YR Increased Lamictal SS Glaxosmithkline ORAL 25MG Per day Confusional State Zyprexa SS Dizziness Topamax SS Erectile Dysfunction Valium C Extrapyramidal Disorder Seizure Medication C UNKNOWN Fatigue Gabapentin C Insomnia Gabatril C Rash Erythematous Rash Pruritic Renal Failure Sexual Dysfunction Date:05/06/04ISR Number: 4354589-1Report Type:Direct Company Report #CTU 218055 E Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Olanzapine 20mg Initial or Prolonged Lilly PS Lilly ORAL 20MG QHS ORAL Required Asa C Intervention to Divalproex C Prevent Permanent Hctz/Triamterene C Impairment/Damage Temazepam C Trazodone C Date:05/06/04ISR Number: 4356317-2Report Type:Expedited (15-DaCompany Report #S04-GER-01931-01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Facial Bones Fracture Health Hydrobromide) PS 20 MG QD Fall Professional Risperdal Grand Mal Convulsion Other (Risperidone) SS 3 MG QD Somnolence Risperdal (Risperidone) SS 4 MG QD Risperdal (Risperidone) SS 5 MG QD Risperdal (Risperidone) SS 6 MG QD Leponex (Clozapine) (Clozapine) SS 12.5 MG QD Leponex (Clozapine) (Clozapine) SS 25 MG QD Zyprexa (Olanzapine) SS 10 MG QD Zyprexa (Olanzapine) SS 15 MG QD Zyprexa (Olanzapine) SS 10 MG QD Zyprexa (Olanzapine) SS 20 MG QD Bronchoretard (Theophylline) SS 350 MG QD Tavor (Lorazepam) C Acetylsalicylic Acid C Pulmicord (Budesonide) C Berotec (Fenoterol Hydrobromide) C 24-Jun-2005 12:19 PM Page: 2877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4354835-4Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0509770A Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Murder Paxil PS Glaxosmithkline Zyprexa SS Date:05/07/04ISR Number: 4355695-8Report Type:Expedited (15-DaCompany Report #S04-USA-02172-01 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Lexapro Initial or Prolonged Coma Professional (Escitalopram) PS Electrocardiogram St Lexapro Segment Elevation (Escitalopram) SS ORAL 10 MG QD PO Family Stress Dapakote (Valproate Medication Error Semisodium) SS Multiple Drug Overdose Zyprexa (Olanzapine) SS Alcohol SS Cocaine SS Date:05/07/04ISR Number: 4356561-4Report Type:Expedited (15-DaCompany Report #JP_040102479 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Zyprexa-Oral Initial or Prolonged Blood Disorder Consumer (Olanzapine) PS 10 MG/DAY Hepatic Function Abnormal Health Eintermin Weight Increased Professional (Chlorpromazine Company Hydrochloride) C Representative Other Date:05/07/04ISR Number: 4356564-XReport Type:Expedited (15-DaCompany Report #GBS040414809 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa-Oral Thrombocytopenia Health (Olanzapine) PS 15 MG DAY Professional Diazepam C Other Citalopram C Temazepam C Date:05/07/04ISR Number: 4356565-1Report Type:Expedited (15-DaCompany Report #FR_040403857 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Foreign Zyprexa-Oral Initial or Prolonged Sedation Health (Olanzapine) PS 10 MG DAY Professional Deroxat (Paroxetine Company Hydrochloride) C Representative Atarax (Hydroxyzine Other Hydrochloride) C Tranxene (Clorazepate Dipotassium) C 24-Jun-2005 12:19 PM Page: 2878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4356566-3Report Type:Expedited (15-DaCompany Report #DE_040413383 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Foreign Zyprexa Velotab-Oral Initial or Prolonged Respiratory Failure Health (Olanzapine) PS 30 MG DAY Other Professional Tavor(Lorazepam) C Other Acc (Acetylcysteine) C Furorese (Furosemide) C Quilonum - Slow Release (Lithium Carbonate) C Date:05/07/04ISR Number: 4356570-5Report Type:Expedited (15-DaCompany Report #DE_040413395 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Zyprexa-Oral Hospitalization - General Physical Health (Olanzapine) PS 5 MG DAY Initial or Prolonged Condition Abnormal Professional Iiird Nerve Paresis Company Paraparesis Representative Psychotic Disorder Other Date:05/07/04ISR Number: 4356572-9Report Type:Expedited (15-DaCompany Report #DE_040413396 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Oral Respiratory Arrest Health (Olanzapine) PS 35MG DAY Professional Valproic Acid C Company Lorazepam C Representative Other Date:05/07/04ISR Number: 4356575-4Report Type:Expedited (15-DaCompany Report #DE_040413429 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Chronic Foreign Zyprexa-Oral Health (Olanzapine) PS Professional Other Date:05/07/04ISR Number: 4356620-6Report Type:Expedited (15-DaCompany Report #JP_040403035 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Company Silece Representative (Flunitrazepam) C Other Contomin (Chlorpromazine Hydrochloride) C Biperiden C 24-Jun-2005 12:19 PM Page: 2879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4356662-0Report Type:Expedited (15-DaCompany Report #JP_040202677 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa Increased Study (Olanzapine) PS ORAL 10 MG/1 DAY Aspartate Health Ciproxan Aminotransferase Professional (Ciprofloxacin Increased Other Hydrochloride) C Blood Creatine Serenace Phosphokinase Increased (Haloperidol) C Blood Lactate Akineton Dehydrogenase Increased (Biperiden Hepatic Function Abnormal Hydrochloride) C Influenza Diazepam C Rohypnol (Flunitrazepam) C Date:05/07/04ISR Number: 4356677-2Report Type:Expedited (15-DaCompany Report #DE_040313273 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:05/07/04ISR Number: 4356691-7Report Type:Expedited (15-DaCompany Report #USA040465474 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax - Olanzapine Professional 6 Mg / Fluoxetine 25 Company Mg (Olanzapine / Representative Fluoxetine) PS 1 MON Date:05/07/04ISR Number: 4356693-0Report Type:Expedited (15-DaCompany Report #USA040464563 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Consumer Symbyax - Olanzapine Contusion / Fluoxetine Disorientation (Unknown Dose) Dysphagia (Olanzapine Dysstasia Fluoxetine) PS Excoriation Fall Hypersomnia Neoplasm Malignant Somnolence 24-Jun-2005 12:19 PM Page: 2880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4356763-7Report Type:Expedited (15-DaCompany Report #JP_031002075 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa Initial or Prolonged Blood Chloride Increased Study (Olanzapine) PS ORAL 5 MG/DAY Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) C Dehydration Other Wypax (Lorazepam) C Fluid Intake Reduced Akineton (Biperiden Hypernatraemia Hydrochloride) C Oral Intake Reduced Selbex Pyrexia (Teprenone) C Rhabdomyolysis Vegetamin A C Waxy Flexibility Depas (Etizolam) C Rohypnol (Flunitrazepam) C Parlodel (Bromocriptine Mesilate) C Ebretid (Distigmine Bromide) C Melleril (Thioridazine Hydrochloride) C Rivotril (Clonazepam) C Date:05/07/04ISR Number: 4356821-7Report Type:Expedited (15-DaCompany Report #GBS040414695 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Zyprexa Other Drug Toxicity Health (Olanzapine) PS ORAL 20 MG DAY Excoriation Professional Stelazine Injury Company (Trifluoperazine Multiple Drug Overdose Representative Hydrochloride) C Nervous System Disorder Other Insulin C Prescribed Overdose Paroxetine C Pulmonary Congestion Pulmonary Oedema Date:05/07/04ISR Number: 4356825-4Report Type:Expedited (15-DaCompany Report #JP_040402942 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 2.5 MG DAY Professional Other Date:05/07/04ISR Number: 4356850-3Report Type:Expedited (15-DaCompany Report #JP_040402971 Age:47 YR Gender:Female I/FU:F Outcome PT Death Apnoea Blood Creatinine Increased 24-Jun-2005 12:19 PM Page: 2881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urea Increased Mydriasis Refusal Of Treatment By Report Source Product Role Manufacturer Route Dose Duration Patient Foreign Zyprexa Health (Olanzapine) PS ORAL 10 MG DAY Professional Linton Company (Haloperidol) C Representative Neuleptil Other (Periciazine) C Levomepromazine C Depas (Etizolam) C Rohipnol (Flunitrazepam) C Thyradin S (Levothyroxine Sodium) C Calslot (Manidipine Hydrochloride) C Diovan (Valsartan) C Lexin (Carbamazepine) C Artane (Trihexyphenidyl Hydrochloride) C Forsenid (Sennoside A+B) C Paxil (Paroxetine Hydrochloride) C Rhythmil (Rilmazafone) C Zyrtec (Cetirizine Hydrochloride) C Pravastatin Sodium C Date:05/07/04ISR Number: 4356859-XReport Type:Expedited (15-DaCompany Report #GBS040414697 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adhesion Foreign Zyprexa Hospitalization - Aspiration Health Dispersible Initial or Prolonged Blood Alcohol Increased Professional (Olanzapine) PS ORAL 15 MG DAY Other Cardiac Disorder Company Anadin C Cerebral Atherosclerosis Representative Sertraline C ORAL Circulatory Collapse Other Coronary Artery Atherosclerosis Drug Screen Positive Drug Toxicity Myocardial Ischaemia Peptic Ulcer Pericardial Disease Scar Date:05/07/04ISR Number: 4356864-3Report Type:Expedited (15-DaCompany Report #EWC040338551 Age:23 YR Gender:Male I/FU:F Outcome PT Hospitalization - Drug Ineffective Initial or Prolonged Generalised Oedema 24-Jun-2005 12:19 PM Page: 2882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oesophagitis Photophobia Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Stevens-Johnson Syndrome Foreign Zyprexa Swollen Tongue Health Velotab Tonsillitis Professional Dispersible Weight Increased Other (Olanzapine) PS 20 MG DAY Tavor (Lorazepam) C Zithromax (Azithromycin) C Date:05/07/04ISR Number: 4356888-6Report Type:Expedited (15-DaCompany Report #DE_040413352 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Foreign Zyprexa Initial or Prolonged Aphagia Health (Olanzapine) PS ORAL 5 MG DAY Disability Aphonia Professional Pipamperone C Brain Stem Syndrome Other Haloperidol C Cerebral Ischaemia Clomethiazole C Condition Aggravated Chlorprothixene C Dementia Lorazepam C General Physical Health Furorese Deterioration (Furosemide) C Iiird Nerve Paresis Kalinor (Potassium Paraparesis Chloride) C Paresis Calcium C Date:05/07/04ISR Number: 4356901-6Report Type:Expedited (15-DaCompany Report #JP_040302888 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa Oral Completed Suicide Study (Olanzapine) PS ORAL 7.5 MG DAY Constipation Health Risperdal Family Stress Professional (Risperidone) C Insomnia Other Hirnamin Multiple Drug Overdose (Levomepromazine) C Paraesthesia Doral (Quazepam) C Persecutory Delusion Gasmotin (Mosapride Citrate) C Sennoside A C Levotomin (Levomepromazine Maleate) C Date:05/07/04ISR Number: 4356902-8Report Type:Expedited (15-DaCompany Report #JP_040202673 Age:55 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Back Pain Condition Aggravated Excitability Hallucination, Auditory Hostility Personality Change Schizophrenia 24-Jun-2005 12:19 PM Page: 2883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Soliloquy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa Study (Olanzapine) PS ORAL 15 MG/3 DAY Health Levotomin Professional (Levomepromazine Other Maleate) C Risperdal (Risperidone) C Akineton (Biperiden Hydrochloride) C Vegetamin B C Rohipnol (Flunitrazepam) C Pantosin (Pantethine) C Magnesium Oxide C Laxoberon (Sodium Picosulfate) C Zyloric (Allopurinol) C Date:05/07/04ISR Number: 4356977-6Report Type:Expedited (15-DaCompany Report #USA040465185 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Zyprexa-Oral Professional (Olanzapine) PS 20 MG Risperdal (Risperidone) C Wellbutrin (Bupropion Hydrochloride) C Date:05/07/04ISR Number: 4357003-5Report Type:Expedited (15-DaCompany Report #USA040465584 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa-Oral Initial or Prolonged Autonomic Nervous System Professional (Olanzapine) Other Imbalance (Olanzapine) PS 10 MG AT Blood Creatine BEDTIME Phosphokinase Increased Lortab C Delirium Electrocardiogram Qt Corrected Interval Prolonged Multiple Drug Overdose Date:05/07/04ISR Number: 4357008-4Report Type:Expedited (15-DaCompany Report #USA040465411 Age:14 YR Gender:Male I/FU:I Outcome PT Hospitalization - Emotional Disorder Of Initial or Prolonged Childhood Oral Intake Reduced 24-Jun-2005 12:19 PM Page: 2884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Suicidal Ideation Tremor Report Source Product Role Manufacturer Route Dose Duration Weight Fluctuation Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG DAY Strattera (Atomoxetine Hydrochloride) SS 40 MG DAY Lexapro (Escitalopram) C Depakote (Valproate Semisodium) C Geodon (Ziprasidone Hydrochloride) C Date:05/07/04ISR Number: 4357232-0Report Type:Expedited (15-DaCompany Report #US_030493862 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Consumer Zyprexa-Oral Initial or Prolonged Anaemia Health (Olanzapine) Other Asthma Professional (Olanzapine) PS Atelectasis Zestril (Lisinopril) C Atrial Pressure Increased Zoloft (Sertraline Bacteraemia Hydrochloride) C Blood Gases Abnormal Aspirin C Blood Glucose Increased Desyrel (Trazodone Blood Osmolarity Hydrochloride) C Decreased Vioxx (Rofecoxib) C Blood Potassium Increased Lopressor Bronchitis (Metoprolol Coma Tartrate) C Cystitis Celebrex (Celecoxib) C Diabetes Mellitus Combivent C Diarrhoea Pepcid (Famotidine) C Fungal Infection Ultram (Tramadol Haemoglobin Decreased Hydrochloride) C Hepatic Steatosis Hyperglycaemia Hypernatraemia Hypokalaemia Mental Status Changes Metabolic Encephalopathy Pancreatitis Pancreatitis Acute Pneumonia Renal Failure Acute Respiratory Failure Sputum Culture Positive Staphylococcal Infection Systemic Inflammatory Response Syndrome Tachycardia Thrombocytopenia Tracheobronchitis Urine Output Decreased Vaginal Infection White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 2885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4357234-4Report Type:Expedited (15-DaCompany Report #USA021022158 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Zyprexa-Oral Drug Toxicity Professional (Olanzapine) Intentional Misuse (Olanzapine) PS Multiple Drug Overdose Date:05/07/04ISR Number: 4357237-XReport Type:Expedited (15-DaCompany Report #USA021123338 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Zyprexa-Oral Congestive Professional (Olanzapine) Coma Company (Olanzapine) PS 20 MG/DAY Fatigue Representative Xanax (Alprazolam) C Myocardial Infarction Paxil (Paroxetine Hydrochloride) C Date:05/07/04ISR Number: 4357244-7Report Type:Expedited (15-DaCompany Report #US_031199068 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Zyprexa-Oral Decreased Appetite Health (Olanzapine) Grandiosity Professional (Olanzapine) PS 30 MG/D DAY Hypersomnia Seroquel (Quetiapine Insomnia Fumarate) C Logorrhoea Ativan (Lorazepam) C Metabolic Disorder Vistaril Pancreatitis Acute (Hydroxyzine Pancreatitis Haemorrhagic Embonate) C Panic Attack Depo Provera Prescribed Overdose (Medroxyprogesterone Psychomotor Hyperactivity Acetate) C Somnolence Ambien (Zolpidem Urinary Tract Infection Tartrate) C Septra C Temazepam C Date:05/10/04ISR Number: 4355794-0Report Type:Direct Company Report #CTU 218232 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa 60 Mg/D PS 60 MG QHS Cleocin C Flumox C Lasix C Haldol C Verapamil C Date:05/10/04ISR Number: 4356308-1Report Type:Direct Company Report #CTU 218279 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa 30 Mg PS ORAL 30 MG PO Depakote C 24-Jun-2005 12:19 PM Page: 2886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/04ISR Number: 4356424-4Report Type:Direct Company Report #CTU 218301 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Olanzapine (Zyprexa) Initial or Prolonged Mental Status Changes Lilly PS Lilly ORAL 40 MG DAILY Metabolic Disorder PO Risperidone C Benztropine C Date:05/10/04ISR Number: 4357377-5Report Type:Expedited (15-DaCompany Report #DSA_24280_2004 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Tavor PS ORAL 0.5 MG QD PO Initial or Prolonged Facial Bones Fracture Health Tavor SS ORAL 1 MG QD PO Fall Professional Tavor SS ORAL 2 MG QD PO Grand Mal Convulsion Other Tavor SS ORAL 2.5 MG QD PO Tavor SS ORAL 4 MG Q DAY PO Bronchoretard SS ORAL 350 MG QD PO Cipramil SS ORAL 20 MG QD PO Leponex SS ORAL 25 MG QD PO Leponex SS ORAL 12.5 MG QD PO Risperdal SS ORAL 6 MG QD PO Risperdal SS ORAL 5 MG QD PO Risperdal SS ORAL 4 MG QD PO Risperdal SS ORAL 3 MG QD PO Zyprexa SS ORAL 10 MG Q DAY PO Zyprexa SS ORAL 20 MG QD PO Zyprexa SS ORAL 15 MG QD PO Zyprexa SS ORAL 10 MG Q DAY PO Acetylsalicylic Acid C Pulmicort C Berotec C Date:05/11/04ISR Number: 4357112-0Report Type:Expedited (15-DaCompany Report #DE_040413430 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa Initial or Prolonged Consciousness Health (Olanzapine) PS 20 MG DAY Facial Bones Fracture Professional Risperdal Fall Other (Risperidone) C Grand Mal Convulsion Leponex (Clozapine) C Cipramil (Citalopram Hydrobromide) C Tavor (Lorazepam) C Ass C Bronchoretard (Theophylline) C Pulmicort Turbuhaler (Budesonide) C Berotec Inhaler (Fenoterol) C 24-Jun-2005 12:19 PM Page: 2887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/04ISR Number: 4357113-2Report Type:Expedited (15-DaCompany Report #AU_040407647 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Foreign Zyprexa Hospitalization - Renal Failure Health (Olanzapine) PS Initial or Prolonged Rhabdomyolysis Professional Tachycardia Other Date:05/11/04ISR Number: 4357114-4Report Type:Expedited (15-DaCompany Report #AU_040407648 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Foreign Zyprexa Hospitalization - Renal Failure Health (Olanzapine) PS Initial or Prolonged Rhabdomyolysis Professional Tachycardia Other Date:05/11/04ISR Number: 4357115-6Report Type:Expedited (15-DaCompany Report #CA_040406864 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Foreign Zyprexa Zydis Health (Olanzapine) PS 20 MG Professional Mevacor (Lovastatin) C Company Loxapine C Representative Ativan (Lorazepam) C Other Date:05/11/04ISR Number: 4357129-6Report Type:Expedited (15-DaCompany Report #JP_030901737 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa Initial or Prolonged Excitability Study (Olanzapine) PS 5 MG/DAY Hallucination, Auditory Health Pakisonal Restlessness Professional (Trihexyphenidyl Schizophrenia Other Hydrochloride) C Suicidal Ideation Tm C Halcion (Triazolam) C Rohypnol (Flunitrazepam) C Rize (Clotiazepam) C Haloperidol C Sennoside A+B C Date:05/11/04ISR Number: 4357522-1Report Type:Direct Company Report #CTU 218404 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Dyazide PS 37.5/25 ONE Hospitalization - Blood Pressure Decreased QD CHRONIC Initial or Prolonged Dehydration Olanzapine SS 7.5 MG QD Required Electrolyte Imbalance Potassium C Intervention to Fall Folic Acid C Prevent Permanent Mental Status Changes Multivitamin C Impairment/Damage Vit B12 C Protonix C 24-Jun-2005 12:19 PM Page: 2888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpromazine C Lorazepam C Date:05/11/04ISR Number: 4358028-6Report Type:Expedited (15-DaCompany Report #MK200405-0043-1 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clomipramine PS Initial or Prolonged Cardiomyopathy Olanzapine SS Drug Ineffective Omeprazole SS Drug Interaction Allopurinol C Drug Toxicity Ejection Fraction Decreased General Physical Health Deterioration Hypokinesia Date:05/11/04ISR Number: 4358256-XReport Type:Direct Company Report #CTU 218366 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Musculoskeletal Stiffness Olanzapine PS Hospitalization - Myalgia Combivir C Initial or Prolonged Nausea Citalopram C Required Pyrexia Bactrim Ds C Intervention to Clotrimazole Troche C Prevent Permanent Lopinavir 133.3 Impairment/Damage Mg/Ritonavir C Baclofen C Clopidogrel C Date:05/11/04ISR Number: 4359498-XReport Type:Expedited (15-DaCompany Report #REL-RIR-122 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Rythmol Catatonia Health (Propafenone) PS ORAL 300 MG QD General Physical Health Professional ORAL Deterioration Other Valpromide SS ORAL 600 MG QD ORAL Domperidone SS ORAL 30 MG QD ORAL Trihexyphenidyl SS ORAL 5 MG QD ORAL Trihexyphenidyl SS ORAL 5 MG QD ORAL Lorazepam SS ORAL 2.5 MG QD ORAL Olanzapine SS ORAL 10 MG QD ORAL Olanzapine SS ORAL 5 MG QD ORAL Date:05/11/04ISR Number: 4361135-5Report Type:Periodic Company Report #US_010770104 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alopecia Initial or Prolonged Anxiety Other Asthma Blood Glucose 24-Jun-2005 12:19 PM Page: 2889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Glucose Increased Blood Thyroid Stimulating Hormone Decreased Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Humulin-Human Nph Diarrhoea Insulin (Rdna) Eating Disorder (Human Insulin (Rd PS 880 U/DAY Goitre Prozac-Oral Haematemesis (Fluoxetine) Hair Texture Abnormal (Fluoxetine Hallucination Hydrochloride) SS Headache Zyprexa-Oral Hypothyroidism (Olanzapine) Insulin Resistance (Olanzapine) SS Iodine Allergy Phentermine C Iron Metabolism Disorder Pondimin Lower Limb Fracture (Fenfluramine Mental Disorder Hydrochloride) C Nausea Levothyroxine C Negativism Armour Thyroid Pain (Thyroid) C Palpitations Glucophage Pernicious Anaemia (Metformin Pharyngolaryngeal Pain Hydrochloride) C Road Traffic Accident Avandia Skin Ulcer (Rosiglitazone Stomach Discomfort Maleate) C Thyroid Neoplasm Vitamins C Vomiting Magnesium C Weight Decreased Chromium C Weight Increased Redux (Dexfenfluramine Hydrochloride) C Novolin (Insulin Human Injection, Isophane) C Seroquel (Quetiapine Fumarate) C Prozac (Fluoxetine Hydrochloride) C Date:05/11/04ISR Number: 4361136-7Report Type:Periodic Company Report #USA040360918 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 10 MG/EVERY DAY 2 MON Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG Date:05/11/04ISR Number: 4361141-0Report Type:Periodic Company Report #USA040155794 Age:30 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Pressure Increased Initial or Prolonged Depression 24-Jun-2005 12:19 PM Page: 2890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 3 WK Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Lithium C Zoloft (Sertraline Hydrochloride) C Date:05/11/04ISR Number: 4361145-8Report Type:Periodic Company Report #USA031152204 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Consumer Zyprexa-Oral Initial or Prolonged Increased Appetite (Olanzapine) PS 15 MG Other Mania Prozac-Oral Weight Increased (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG Depakote (Valoprate Semisodium) C Antidepressant C Date:05/11/04ISR Number: 4361151-3Report Type:Periodic Company Report #USA031048735 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-Oral Initial or Prolonged Dyskinesia (Olanzapine) PS 10 MG Middle Insomnia Prozac-Oral Movement Disorder (Fluoxetine) Suicidal Ideation (Fluoxetine Weight Increased Hydrochloride) SS Effexor-Xr (Venlafaxine Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Date:05/11/04ISR Number: 4361156-2Report Type:Periodic Company Report #USA030740995 Age:41 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Dreams Initial or Prolonged Blood Glucose Decreased Other Convulsion Dental Caries Diabetes Mellitus Hallucination Hallucination, Auditory 24-Jun-2005 12:19 PM Page: 2891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injury Libido Increased Paranoia Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Consumer Zyprexa-Oral Psychomotor Hyperactivity (Olanzapine) Road Traffic Accident (Olanzapine) PS 30 MG/AT Skin Atrophy BEDTIME Skin Striae Prozac-Oral Suicidal Ideation (Fluoxetine)(Fluoxet Weight Decreased ine Hydrochloride) SS 20 MG/2 DAY Weight Increased Tegretol (Carbamazepine) C Date:05/12/04ISR Number: 4357590-7Report Type:Direct Company Report #CTU 218459 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Effexor 37.5 Mg PS ORAL 37.5 MG QD Initial or Prolonged Delirium ORAL Disability Paranoia Zyprexa 2.5 Mg SS ORAL 2.5 MG QHS ORAL Date:05/12/04ISR Number: 4358387-4Report Type:Direct Company Report #CTU 218539 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Zyprexa 20 Mg PS ORAL 20 MG PO QD 4 DAY Increased Low Density Lipoprotein Increased Date:05/12/04ISR Number: 4358930-5Report Type:Expedited (15-DaCompany Report #US_0404102553 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Consumer Zyprexa-Oral Other Pancreatitis Acute (Olanzapine) (Olanzapine) PS Date:05/12/04ISR Number: 4358931-7Report Type:Expedited (15-DaCompany Report #USA040466241 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Health Zyprexa-Oral Initial or Prolonged Living Impaired Professional (Olanzapine) Condition Aggravated (Olanzapine) PS 7.5 MG Dementia Alzheimer'S Type Celebrex (Celecoxib) C Fall Synthroid Hip Fracture (Levothyroxine Nasopharyngitis Sodium) C Zocor (Simvastatin) C Zanaflex (Tizanidine Hydrochloride) C Depakote (Valproate Semisodium) C Celexa (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 2892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/04ISR Number: 4358935-4Report Type:Expedited (15-DaCompany Report #USA040465695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Prozac-Oral Glossoptosis (Fluoxetine) Loss Of Consciousness (Fluoxetine Hydrochloride) PS 20 MG/1 DAY 1 MON Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG/1 DAY 2 MON Cogentin (Benzatropine Mesilate) C Date:05/12/04ISR Number: 4359254-2Report Type:Expedited (15-DaCompany Report #USA040465480 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Zyprexa-Oral Initial or Prolonged Exposure To Therapeutic Professional (Olanzapine) Drugs (Olanzapine) PS 20 MG/1 AT Injury BEDTIME Road Traffic Accident Lithium C Date:05/12/04ISR Number: 4359257-8Report Type:Expedited (15-DaCompany Report #USA040464142 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Symbyax-Olanzapine/F Professional luoxetine (Unknown Company Dose) (Ola PS 1 WK Representative Lorazepam C Date:05/12/04ISR Number: 4359259-1Report Type:Expedited (15-DaCompany Report #USA040464492 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Health Symbyax-Olanzapine Initial or Prolonged Increased Professional 6mg /Fluoxetine 25mg Other Cerebrovascular Accident Company (Olanzapin PS 1 DSG FORM/1 Oedema Peripheral Representative DAY Celexa (Citalopram Hydrobromide) C Zocor (Simvastatin) C Date:05/12/04ISR Number: 4359316-XReport Type:Expedited (15-DaCompany Report #EWC040338662 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cataract Foreign Olanzapine Confusional State Health (Olanzapine) PS ORAL 2.5 MG DAY Delusion Professional Furosemide C Paranoia Other Captopril C Refusal Of Treatment By Citalopram C Patient Ferrosi Fumaras C Sudden Death Flurazepam C Homeopathic Agent C 24-Jun-2005 12:19 PM Page: 2893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) C Date:05/12/04ISR Number: 4359318-3Report Type:Expedited (15-DaCompany Report #JP_040302766 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Foreign Zyprexa Initial or Prolonged Living Impaired Study (Olanzapine) PS 5 MG/1 DAY Other Akathisia Health Rohiphnol Anorexia Professional (Flunitrazepam) C Asocial Behaviour Other Myslee (Zolpidem Bedridden Tartrate) C Depressive Symptom Akineton (Biperiden Insomnia Hydrochloride) C Nasopharyngitis Nightmare Psychiatric Symptom Suicidal Ideation Treatment Noncompliance Date:05/12/04ISR Number: 4359320-1Report Type:Expedited (15-DaCompany Report #DE_040413383 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa Velotab Initial or Prolonged Pneumonia Mycoplasmal Health (Olanzapine) PS ORAL 30 MG DAY Sleep Apnoea Syndrome Professional Tavor (Lorazepam) C Other Acc (Acetylcysteine) C Furorese (Furosemide) C Quilonum-Slow Release (Lithium Carbonate) C Date:05/12/04ISR Number: 4359323-7Report Type:Expedited (15-DaCompany Report #FR_040203580 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa Initial or Prolonged Femur Fracture Health (Olanzapine) PS ORAL 10 MG/DAY Prothrombin Time Professional Depakine (Valproate Prolonged Other Sodium) C Valium (Diazepam) C Tetrazepam C Duphalac (Lactulose) C Date:05/12/04ISR Number: 4359519-4Report Type:Expedited (15-DaCompany Report #USA030229610 Age:85 YR Gender:Female I/FU:I Outcome PT Death Agitation Aphagia Aphasia Blood Glucose Increased Cerebrovascular Accident 24-Jun-2005 12:19 PM Page: 2894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Crying Drug Ineffective Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Glucotrol (Glipizide) C Insulin C Date:05/12/04ISR Number: 4359521-2Report Type:Expedited (15-DaCompany Report #USA040362266 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Consumer Zyprexa-Oral Exposure To Therapeutic (Olanzapine) Drugs (Olanzapine) PS 10 MG DAY Induced Labour Zoloft (Sertraline Pre-Eclampsia Hydrochloride) C Red Blood Cell Count Wellbutrin(Bupropion Increased Hydrochloride) C Date:05/12/04ISR Number: 4359522-4Report Type:Expedited (15-DaCompany Report #USA040465590 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Health Zyprexa-Oral Initial or Prolonged Prescribed Overdose Professional (Olanzapine) (Olanzapine) PS 30 MG Date:05/12/04ISR Number: 4359523-6Report Type:Expedited (15-DaCompany Report #USA040465678 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Zyprexa-Oral Initial or Prolonged Contusion (Olanzapine) Other Convulsion (Olanzapine) PS Drug Hypersensitivity Forteo Fall (Teriparatide) SS Haematoma Fosamax (Alendronate Loss Of Consciousness Sodium) C Calcium C Celexa (Citalopram Hydrobromide) C Date:05/12/04ISR Number: 4359524-8Report Type:Expedited (15-DaCompany Report #USA040465685 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericarditis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 7.5 MG DAY Lexapro (Escitalopram) C 24-Jun-2005 12:19 PM Page: 2895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/04ISR Number: 4359527-3Report Type:Expedited (15-DaCompany Report #USA040465747 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/12/04ISR Number: 4359529-7Report Type:Expedited (15-DaCompany Report #USA040465748 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Consumer Zyprexa-Oral Initial or Prolonged Glucose Tolerance (Olanzapine) Impaired (Olanzapine) PS Lactose Intolerance Despiramine C Uterine Cancer Prolixin Vomiting (Fluphenazine Hydrochloride) C Date:05/12/04ISR Number: 4359533-9Report Type:Expedited (15-DaCompany Report #US_0403101897 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Consumer Zyprexa-Oral Hospitalization - Completed Suicide (Olanzapine) Initial or Prolonged Convulsion (Olanzapine) PS 30 MG DAY Gun Shot Wound Mellaril Intentional Misuse (Thioridazine Personality Change Hydrochloride) C Advair C Clonazepam C Phenytoin C Ambien (Zolpidem Tartrate) C Protonix (Pantoprazole) C Combivent C Methocarbamol C Hydrocodone W/Apap C Famotidine C Zanaflex (Tizanidine Hydrochloride) C Diazepam C Belladonna Alkaloids C Carisoprodol C Promethiazine C Atropine W/Diphenoxylate C Sulfamethoxazole W/Trimethoprim C Skelaxin (Metaxalone) C Amoxicillin C Propoxyphene C Tetracycline C Tylenol W/Codeine No. 3 C Metoclopramide C 24-Jun-2005 12:19 PM Page: 2896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin (Gabapentin) C Temazepam C Zithromax (Azithromycin) C Albuterol C Tequin (Gatifloxacin) C Wellbutrin Sr (Bupropion Hydrochloride) C Chlorpromazine C Nicotrol (Nicotine) C Ultram (Tramadol Hydrochloride) C Lorazepam C Penicillin Vk (Phenoxymethylpenici llin Potassim) C Trazadone (Trazodone) C Seroquel (Quetiapine Fumarate) C Ketorolac C Depakote (Valoproate Semisodiuim) C Diflucan (Fluconazole) C Premphase C Hyoscyamine C Dicyclomine (Dicycloverine) C Tizanidine C Vioxx (Rofecoxib) C Date:05/12/04ISR Number: 4359546-7Report Type:Expedited (15-DaCompany Report #EWC040438985 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Zyprexa Oral Other Atrial Fibrillation Health (Olanzapine)(Olanzap Cardiac Failure Professional ine) PS 5 MG DAY Cardiovascular Disorder Other Hemiverin Constipation (Clomethiazole Electrocardiogram T Wave Edisilate) C Abnormal Remeron C Jaundice Movicol C Peritonitis Felodipine C Pulmonary Oedema Propavan (Propiomazine Maleate) C Theralen (Alimemazine Tartrate) C Nitroglycerin Nm Pharma (Glyceryl Trinitrate) C Trombyl (Acetylsalicylic Acid) C 24-Jun-2005 12:19 PM Page: 2897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Proscar (Finasteride) C Imdur (Isosorbide Mononitrate) C Zopiclone C Metformin C Date:05/12/04ISR Number: 4359548-0Report Type:Expedited (15-DaCompany Report #FR_040403997 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Foreign Zyprexa Oral Initial or Prolonged Increased Health (Olanzapine)(Olanzap Hepatocellular Damage Professional ine) PS 30 MG/1 DAY Other Teralithe (Lithium Carbonate) C Largactil (Chlorpromazine Hydrochloride) C Rivotril (Clonazepam) C Date:05/12/04ISR Number: 4359555-8Report Type:Expedited (15-DaCompany Report #JP_040403038 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusion Foreign Zyprexa Oral Other Diet Refusal Health (Olanzapine)(Olanzap Hallucination Professional ine) PS 30 MG DAY Prescribed Overdose Company Wypax (Lorazepam) C Refusal Of Treatment By Representative Carbamazepine C Patient Other Chlorpromazine C Stupor Levotomin (Levomepromazine Maleate) C Alosenn C Date:05/12/04ISR Number: 4359603-5Report Type:Expedited (15-DaCompany Report #FR_040303758 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa Oral Health (Olanzapine)(Olanzap Professional ine) PS 10 MG/1 DAY Other Haldol (Haloperidol) C Lexomil (Bromazepam) C Date:05/12/04ISR Number: 4359723-5Report Type:Expedited (15-DaCompany Report #CA_040406897 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa Health Zydis-Dispersible Professional (Olanzapine) Other (Olanzapine) PS 5 MG 24-Jun-2005 12:19 PM Page: 2898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/04ISR Number: 4359726-0Report Type:Expedited (15-DaCompany Report #DE_040413455 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/2 DAY Other Date:05/12/04ISR Number: 4359728-4Report Type:Expedited (15-DaCompany Report #JP_040102479 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Zyprexa-Oral Initial or Prolonged Blood Disorder Consumer (Olanzapine) Hepatic Function Abnormal Health (Olanzapine) PS 10 MG/DAY Weight Increased Professional Wintermin Company (Chlorpromazine Representative Hydrochloride) C Other Date:05/12/04ISR Number: 4359729-6Report Type:Expedited (15-DaCompany Report #DE_030511317 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zyprexa Valotab-Oral Initial or Prolonged Literature (Olanzapine) Health (Olanzapine) PS 10 MG IN THE Professional EVENING Other Date:05/13/04ISR Number: 4359595-9Report Type:Expedited (15-DaCompany Report #2003035058 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Albumin Globulin Ratio Disability Decreased Other Anaemia Asthma Band Neutrophil Count Increased Blood Albumin Decreased Bronchitis Candidiasis Disease Recurrence Fungal Infection Herpes Virus Infection Insomnia Leukocytoclastic Vasculitis Neutrophil Percentage Decreased Onychomadesis Photosensitivity Allergic Reaction Protein Total Decreased Pruritus Generalised Psychosomatic Disease 24-Jun-2005 12:19 PM Page: 2899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stevens-Johnson Syndrome Tinea Cruris Toxic Epidermal Report Source Product Role Manufacturer Route Dose Duration Necrolysis Consumer Zithromax (Caps) Treatment Noncompliance (Azithromycin) PS ORAL UNK (UNK, 1 Upper Gastrointestinal IN 1 D), ORAL Haemorrhage Carbamazepine Vision Blurred (Carbamazepine) SS ORAL 400 MG (200 MG, 2 IN 1 D), ORAL Olanzapine (Olanzapine) SS ORAL 5 MG (UNK, 1 IN 1 D), ORAL Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:05/14/04ISR Number: 4358615-5Report Type:Expedited (15-DaCompany Report #FRWYE740804MAY04 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Temesta (Lorazepam, Catatonia Professional Tablet, 0) PS ORAL 2.5 MG 1X PER Other 1 DAY Motilium (Domperidone, , 0) SS ORAL 30 MG 1X PER 1 DAY Parkinane (Trihyexyphenidyl, Tablet, 0) SS ORAL 5 MG 1X PER 1 DAY Rythmol (Propafenone Hydrochloride, , 0) SS ORAL 300 MG 1X PER 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 10 MG 1X PER 1 DAY 61 DAY Date:05/14/04ISR Number: 4360342-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500945 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Study Risperidone Initial or Prolonged Gastrointestinal Necrosis Health (Risperidone) Intestinal Ischaemia Professional Unspecified PS Mental Status Changes Olanzapine Pneumonia (Olanzapine) SS Quetiapine (Quetiapine) SS Trazodone (Trazodone) C Mvi (Multivitamins) C Feso4 (Ferrous Sulfate) C Carbamazepine (Carbamazepine) C 24-Jun-2005 12:19 PM Page: 2900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/04ISR Number: 4359120-2Report Type:Direct Company Report #CTU 218744 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypoxia Zyprexa (Zydis) 5 Mg PS ORAL 2.5 MG PO Hospitalization - Livedo Reticularis BID; 25 MG PO Initial or Prolonged Neuroleptic Malignant QHS; 5 MG PO Required Syndrome PRN Intervention to Haldol 5 Mg/Ml Prevent Permanent Injections SS INTRAVENOUS 1MG IV Q4HOUR Impairment/Damage PRN; 1MG IV Q8HOUR PRN; 2 MG IV Q6HOUR PRN; 2MG IV Date:05/17/04ISR Number: 4360867-2Report Type:Expedited (15-DaCompany Report #2004SE02609 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Foreign Seroquel PS ORAL 75 MG DAILY Life-Threatening Increased Health PO Dysarthria Professional Zyprexia SS ORAL 5 MG DAILY PO Neuroleptic Malignant Other Zyprexia SS ORAL 7.5 MG DAILY Syndrome PO Fluanxol C Date:05/17/04ISR Number: 4362189-2Report Type:Expedited (15-DaCompany Report #04P-163-0259510-00 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Depakote (Divalproex Initial or Prolonged Electrocardiogram St Professional Sodium) (Divalproex Segment Other Sodium) PS SEE IMAGE Multiple Drug Overdose Lexapro Film-Coated Tablets (Escitalopram) (Escitalopram) (Escitalopram) SS SEE IMAGE Olanzapine SS Ethanol SS Cocaine SS Date:05/17/04ISR Number: 4362220-4Report Type:Expedited (15-DaCompany Report #2004029509 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antidepressant Drug Level Health Zoloft (Sertraline) PS (100 MG) Increased Professional Olanzapine Drug Level Increased (Olanzapine) SS (5 MG) Valproate Semisodium (Valproate Semisodium) SS 24-Jun-2005 12:19 PM Page: 2901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/04ISR Number: 4360653-3Report Type:Direct Company Report #CTU 218913 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Unevaluable Event Zyprexa PS Date:05/20/04ISR Number: 4364919-2Report Type:Expedited (15-DaCompany Report #USA040464215 Age:5 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Application Site Vesicles (Olanzapine) Bacteria Urine Identified (Olanzapine) PS 10 MG Feeling Hot Concerta Food Craving (Methylphenidate Hallucination, Auditory Hydrochloride) C Increased Appetite Clonidine C Mania Ritalin La Polydipsia (Methylphenidate Polyuria Hydrochloride) C Weight Increased Date:05/20/04ISR Number: 4365091-5Report Type:Expedited (15-DaCompany Report #6008694 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Levothyrox 75 Cyanosis Professional (Tablets) Respiratory Arrest Other (Levothyroxine Sudden Death Sodium) PS ORAL 75 MCG (75 MCG, 1 IN 1 D); ORAL Lexomil (6 Microgram, Tablets)( Bromazepam) SS ORAL 0,25 DOSAGE FORM (0,25 DOSAGE FORMS, 1 IN 1 D);ORAL Ixel (Capsules) (Milinacipran) SS ORAL 25 MG (25 MG, 1 IN 1 D); ORAL Zyprexa (Tablets) (Olanzapine) SS ORAL 25 MG (25 MG, 1 IN 1 D); ORAL Date:05/20/04ISR Number: 4365949-7Report Type:Expedited (15-DaCompany Report #200410330BNE Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Oxygen Saturation Foreign Ciprofloxacin PS ORAL 500 MG, BID, Decreased Health ORAL Somnolence Professional Zyprexa (Olanzapine) SS ORAL 20 MG, TOTAL Unresponsive To Pain Other DAILY, ORAL; Stimuli 10 MG, TOTAL DAILY, ORAL Haloperidol C 24-Jun-2005 12:19 PM Page: 2902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone C Senna C Salbutamol C Ipratropium C Beclomethasone C Mil-Par C Prednisolone C Paracetamol C Codeine C Tinzaparin C Date:05/20/04ISR Number: 4365963-1Report Type:Expedited (15-DaCompany Report #S04-GER-02020-01 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Seroplex Initial or Prolonged Bradycardia Health (Escitalopram) PS ORAL 480 MG ONCE Other Coma Professional PO Cyanosis Other Seroplex Electrocardiogram Qt (Escitalopram) SS ORAL 15 MG QD PO Prolonged Seroplex Hypotension (Escitalopram) SS ORAL 15 MG QD PO Intentional Misuse Seroplex Malaise (Escitalopram) SS Pallor Zyprexa (Olanzapine) SS ORAL 67 TABLET Suicide Attempt ONCE PO Syncope Vasovagal Zyprexa (Olanzapine) SS Vertigo Zyprexa (Olanzapine) SS ORAL 30 MG QD PO Zyprexa (Olanzapine) SS Quitaxon (Doxepin Hydrochloride) SS ORAL 20 TABLET ONCE PO Athymil (Mianserin Hydrochloride) SS Seropram (Citalopram Hydrobromide) C Rivotril (Clonazepam) C Date:05/21/04ISR Number: 4364664-3Report Type:Expedited (15-DaCompany Report #USA040566479 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Strattera Life-Threatening Anxiety Professional (Atomoxetine Hospitalization - Brain Death Company Hydrochloride) PS 80 MG DAY Initial or Prolonged Cardiac Arrest Representative Zyprexa-Oral Loss Of Consciousness (Olanzapine) (Olanzapine) SS 2.5 MG DAY Celexa (Citalopram Hydrobromide) C Mirapex (Mirapex) C 24-Jun-2005 12:19 PM Page: 2903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/04ISR Number: 4364760-0Report Type:Expedited (15-DaCompany Report #US_0405102840 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Zyprexa-Oral Physical Assault (Olanzapine) Theft (Olanzapine) PS Zoloft (Sertraline Hydrochloride) C Desyrel (Trazadone Hydrochloride) C Date:05/21/04ISR Number: 4364766-1Report Type:Expedited (15-DaCompany Report #US_0405102894 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa-Oral Initial or Prolonged Electrocardiogram St Professional (Olanzapine) Segment (Olanzapine) PS Legal Problem Lexapro Multiple Drug Overdose (Escitalopram) C Self-Medication Depakote (Valproate Semisodium) C Cocaine C Alcohol C Date:05/21/04ISR Number: 4364767-3Report Type:Expedited (15-DaCompany Report #US_031199068 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Zyprexa-Oral Blood Amylase Decreased Health (Olanzapine) Blood Chloride Increased Professional (Olanzapine) PS 30 MG/D DAY Blood Glucose Increased Seroquel (Quetiapine Blood Potassium Increased Fumarate) C Blood Sodium Increased Ativan (Lorazepam) C Blood Urea Increased Vistaril Decreased Appetite (Hydroxyzine Drug Level Increased Embonate) C Grandiosity Depo Provera Headache (Medroxyprogesterone Insomnia Acetate) C Logorrhoea Ambien (Zolpidem Metabolic Disorder Tartrate) C Pancreatitis Haemorrhagic Septra C Panic Attack Temazepam C Pco2 Decreased Psychomotor Hyperactivity Refusal Of Treatment By Patient Somnolence Urinary Tract Infection Date:05/21/04ISR Number: 4364772-7Report Type:Expedited (15-DaCompany Report #USA040566844 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) 24-Jun-2005 12:19 PM Page: 2904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS Zoloft (Sertraline Hydrochloride) C Date:05/21/04ISR Number: 4364774-0Report Type:Expedited (15-DaCompany Report #USA040566730 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Capoten (Captopril) C Diazene C Date:05/21/04ISR Number: 4364776-4Report Type:Expedited (15-DaCompany Report #USA040566525 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprex-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 5 MG AT Representative BEDTIME Zoloft (Sertraline Hydrochloride) C Depakote (Valproate Semisodium) C Date:05/21/04ISR Number: 4364779-XReport Type:Expedited (15-DaCompany Report #USA040566457 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) Other Pneumonia (Olanzapine) PS 15 MG DAY Respiratory Failure Lasix (Furosemide) C Atenolol C Date:05/21/04ISR Number: 4364795-8Report Type:Expedited (15-DaCompany Report #USA040466296 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Consumer Zyprexa-Oral Initial or Prolonged Hallucination, Visual (Olanzapine) Hypomania (Olanzapine) PS 15 MG/1 AT Paranoia BEDTIME Psychotic Disorder Depakote (Valproate Treatment Noncompliance Semisodium) C Lisinopril C Lopressor (Metoprolol Tartrate) C 24-Jun-2005 12:19 PM Page: 2905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/04ISR Number: 4364869-1Report Type:Expedited (15-DaCompany Report #US_030493865 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Consumer Zyprexa-Oral Diabetes Mellitus Health (Olanzapine) Mammogram Abnormal Professional (Olanzapine) PS 30 MG/DAY Overdose Company Benadryl(Diphenhydra Therapeutic Agent Representative mine Hydrochloride) C Toxicity Lamictal(Lamotrigine Treatment Noncompliance ) C Tremor Synthroid(Levothyrox ine Sodium) C Avandia(Rosiglitazon e Maleate) C Prevacid(Lansoprazol e) C Atenolol C Claritin-D C Propanolol C Metformin C Loratadine C Lansoprazole C Simethicone C Cipro(Ciprofloxacin Hydrochloride) C Vicodin C Atenolol C Lescol (Fluvastatin Sodium) C Bactrim Ds C Colace (Docusate Sodium) C Toradol (Ketorolac Tromethamine) C Kefzol(Cefazolin Sodium) C Date:05/21/04ISR Number: 4364909-XReport Type:Expedited (15-DaCompany Report #USA030229610 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphagia Consumer Zyprexa-Oral Aphasia (Olanzapine) Blood Glucose Increased (Olanzapine) PS Cerebrovascular Accident Glucotrol Drug Ineffective (Glipizide) C Insulin C Date:05/21/04ISR Number: 4364912-XReport Type:Expedited (15-DaCompany Report #US_021190277 Age:48 YR Gender:Female I/FU:F Outcome PT Death Blood Bicarbonate Hospitalization - Decreased Initial or Prolonged Blood Chloride Decreased Other Blood Creatine Phosphokinase Increased Coagulopathy Encephalopathy 24-Jun-2005 12:19 PM Page: 2906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemoglobin Decreased Lethargy Leukocytosis Report Source Product Role Manufacturer Route Dose Duration Mental Status Changes Health Zyprexa-Oral Neuroleptic Malignant Professional (Olanzapine) Syndrome Company (Olanzapine) PS 25 MG DAY Pulmonary Embolism Representative Lorazepam C Renal Failure Acute Coumadin (Warfarin Renal Tubular Necrosis Sodium) C Respiratory Failure Mirtazapine C Rhabdomyolysis Thrombocytopenia White Blood Cell Count Increased Date:05/21/04ISR Number: 4364916-7Report Type:Expedited (15-DaCompany Report #USA040466241 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Health Zyprexa-Oral Initial or Prolonged Living Impaired Professional (Olanzapine) Condition Aggravated (Olanzapine) PS 7.5 MG Cough Celebrex (Celecoxib) C Dementia Alzheimer'S Type Synthroid Fall (Levothyroxine Hip Arthroplasty Sodium) C Hip Fracture Zocor (Simvastatin) C Nasopharyngitis Zanaflex (Tizanidine Hydrochloride) C Depakote (Valproate Semisodium) C Celexa (Citalopram Hydrobromide) C Date:05/21/04ISR Number: 4364924-6Report Type:Expedited (15-DaCompany Report #USA040362439 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa-Oral Other Weight Increased Professional (Olanzapine) Company (Olanzapine) PS 10 MG DAY Representative Oxycontin (Oxycodone Hydrochloride) C Ambien (Zolpidem Tartrate) C Xanax (Alprazolam) C Paxil (Paroxetine Hydrochloride) C Date:05/21/04ISR Number: 4364959-3Report Type:Expedited (15-DaCompany Report #EWC040539080 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Foreign Zyprexa Hospitalization - Health Oral PS ORAL 5 MG/1 DAY Initial or Prolonged Professional Other 24-Jun-2005 12:19 PM Page: 2907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/04ISR Number: 4364963-5Report Type:Expedited (15-DaCompany Report #AU_040507673 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Facial Spasm Foreign Zyprexa Hospitalization - Muscle Rigidity Health Initial or Prolonged Oral Intake Reduced Professional (Olanzapine) PS ORAL 5 MG Rash Other Zoloft (Sertraline Tardive Dyskinesia Hydrochloride) C Prednisolone C Losec (Omeprazole) C Date:05/21/04ISR Number: 4364966-0Report Type:Expedited (15-DaCompany Report #AU_040507675 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Foreign Zyprexa Prolonged Health (Olanzapine) PS INTRAMUSCULAR IM Professional Company Representative Other Date:05/21/04ISR Number: 4365072-1Report Type:Expedited (15-DaCompany Report #DE_040313182 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa Corrected Interval Health (Olanzapine) PS ORAL 10 MG DAY 2 MON Prolonged Professional Zocor (Simvastatin) C Company Doxepin C Representative Other Date:05/21/04ISR Number: 4365074-5Report Type:Expedited (15-DaCompany Report #EWC040338450 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG DAY 3 MON Professional Company Representative Other Date:05/21/04ISR Number: 4365623-7Report Type:Expedited (15-DaCompany Report #CA_040306711 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Foreign Zyprexa-Oral Initial or Prolonged Retinal Haemorrhage Consumer (Olanzapine) Other Health (Olanzapine) PS 2.5 MG DAY Professional Other 24-Jun-2005 12:19 PM Page: 2908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/04ISR Number: 4365624-9Report Type:Expedited (15-DaCompany Report #JP_040102565 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accident Foreign Zyprexa-Oral Depressed Level Of Study (Olanzapine) Consciousness Health (Olanzapine) PS 5 MG/DAY Fall Professional Impromen Gait Disturbance Other (Bromperidol) C Akineton (Biperiden Hdyrochloride) C Doral (Quazepam) C Eurodin (Estazolam) C Depas (Etizolam) C Forsenid (Sennoside A+B) C Pantosin (Pantethine) C Magnesium Oxide Heavy C Date:05/21/04ISR Number: 4365929-1Report Type:Expedited (15-DaCompany Report #JP_040302766 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa-Oral Initial or Prolonged Anorexia Study (Olanzapine) Other Bedridden Health (Olanzapine) PS 5 MG/1 DAY Condition Aggravated Professional Rohipnol Depressive Symptom Other (Flunitrazepam) C Insomnia Myslee (Zolpidem Nasopharyngitis Tartrate) C Nightmare Akineton (Biperiden Psychiatric Symptom Hydrochloride) C Suicidal Ideation Treatment Noncompliance Date:05/24/04ISR Number: 4363578-2Report Type:Direct Company Report #CTU 219265 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Zyprexa 2.5 Mg PS ORAL 2.5 MG PO BID Initial or Prolonged Delirium Date:05/24/04ISR Number: 4363580-0Report Type:Direct Company Report #CTU 219266 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Zyprexa 15 Mg PS ORAL 15 MG PO QHS Initial or Prolonged Abnormal Date:05/24/04ISR Number: 4366629-4Report Type:Expedited (15-DaCompany Report #DSA_24364_2004 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Death Agitation Foreign Catatonia Health Professional 24-Jun-2005 12:19 PM Page: 2909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Temesta PS ORAL 2.5 MG QD PO ; A FEW YEARS YR Motilium SS ORAL 30 MG QD PO Parkinane SS ORAL 5 MG QD PO Rythmol SS ORAL 300 MG QD PO Zyprexa SS ORAL 10 MG QD PO Date:05/25/04ISR Number: 4365370-1Report Type:Expedited (15-DaCompany Report #USA040466223 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Prozac-Oral Drug Toxicity Professional (Fluoxetine) Marital Problem Company (Fluoxetine Weight Decreased Representative Hydrochloride) PS 80 MG/1 DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 30 MG DAY Eskalith (Lithium Carbonate) C Alprazolam C Ritalin (Methylphenidate Hydrochloride) C Date:05/25/04ISR Number: 4368912-5Report Type:Expedited (15-DaCompany Report #2004032070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS 120 MG (60 Initial or Prolonged Insomnia Professional MG, BID Social Avoidant Behaviour Company INTERVAL: Representative EVERY DAY) Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) SS (50 MG) Olanzapine SS (20 MG) Zolpidem Tartrate (Zolpidem Tartrate) SS (20 MG) Date:05/26/04ISR Number: 4365431-7Report Type:Direct Company Report #CTU 219548 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Symbax 12/25 Mg PS ORAL 12/25 MG PO Q Initial or Prolonged DINNER Asa C Altace C Norvasc C Lasix C Clonidine C Coumadin C Restoril C 24-Jun-2005 12:19 PM Page: 2910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4365712-7Report Type:Direct Company Report #CTU 219541 E Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Olanzapine PS 20 MG QHS Hospitalization - Body Temperature [PRIOR TO Initial or Prolonged Decreased ARRIVAL] Bradycardia Risperidone SS PTA Depressed Level Of Carabamazepine C Consciousness Trazodone C Fluconazole C Unasyn C Date:05/26/04ISR Number: 4367694-0Report Type:Periodic Company Report #USA030947719 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Strattera Initial or Prolonged Drug Effect Decreased (Atomexetine Prescribed Overdose Hydrochloride) PS 80 MG/2 DAY Psychomotor Hyperactivity Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) SS 5 MG/DAY Date:05/26/04ISR Number: 4367695-2Report Type:Periodic Company Report #USA030845647 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Gynaecomastia Company (Olanzapine) PS 20 MG/AT Hyperglycaemia Representative BEDTIME Atenolol C Clonazepam C Trazodone C Protonix (Pantoprazole) C Chlorthalidone C Zestril (Lisinopril) C Reglan (Metoclopramide) C Date:05/26/04ISR Number: 4367696-4Report Type:Periodic Company Report #USA030844577 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 20 MG/AT Other Representative BEDTIME Lithium C Depakote (Valproate Semisodium) C Inderal (Propranolol Hydrochloride) C Lasix (Furosemide) C Potassium C 24-Jun-2005 12:19 PM Page: 2911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4367697-6Report Type:Periodic Company Report #USA030844168 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Consumer Zyprexa-Oral Initial or Prolonged Muscle Twitching (Olanzapine) Schizophreniform Disorder (Olanzapine) PS 2.5 MG/DAY Ambien (Zolpidem Tartrate) C Wellbutrin (Bupropion Hydrochloride) C Date:05/26/04ISR Number: 4367698-8Report Type:Periodic Company Report #USA030843896 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4367699-XReport Type:Periodic Company Report #USA030741601 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 5 MG/1 DAY Representative Trileptal (Oxcarbazepine) C Seroquel (Quetiapine Fumarate) C Date:05/26/04ISR Number: 4367700-3Report Type:Periodic Company Report #USA030741096 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Intentional Misuse Professional (Olanzapine) Company (Olanzapine) PS 5 MG/DAY Representative Date:05/26/04ISR Number: 4367701-5Report Type:Periodic Company Report #USA030740995 Age:41 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Dreams Initial or Prolonged Blood Glucose Decreased Other Convulsion Dental Caries Diabetes Mellitus Hallucination Hallucination, Auditory Injury Libido Increased Paranoia Prescribed Overdose Psychomotor Hyperactivity 24-Jun-2005 12:19 PM Page: 2912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Road Traffic Accident Skin Atrophy Skin Striae Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Consumer Zyprexa-Oral Weight Decreased (Olanzapine) Weight Increased (Olanzapine) PS 30 MG/AT BEDTIME Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/ 2 DAY Tegretol (Carbamazepine) C Date:05/26/04ISR Number: 4367705-2Report Type:Periodic Company Report #USA030538179 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Axillary Pain Consumer Zyprexa-Oral Initial or Prolonged Blindness Health (Olanzapine) Other Breast Engorgement Professional (Olanzapine) PS 10 MG/2 DAY Breast Swelling Breast Tenderness Confusional State Dehydration Dizziness Dry Throat Dysstasia Feeling Abnormal Gait Disturbance Groin Pain Hangover Hypersomnia Hypertrophy Breast Increased Appetite Injury Local Swelling Loss Of Consciousness Musculoskeletal Stiffness Nightmare Somnolence Vaginal Discharge Vomiting Date:05/26/04ISR Number: 4367706-4Report Type:Periodic Company Report #USA030433103 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4367707-6Report Type:Periodic Company Report #USA031051068 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Zyprexa-Oral Initial or Prolonged Asthenia (Olanzapine) Back Pain (Olanzapine) PS 10 MG/IN THE Chest Pain MORNING Coma Depakote (Valproate Diabetes Mellitus Semisodium) C Drug Ineffective Feeling Abnormal Headache Hyperglycaemia Nervousness Date:05/26/04ISR Number: 4367708-8Report Type:Periodic Company Report #USA031050739 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) Representative (Olanzapine) PS 10 MG Date:05/26/04ISR Number: 4367709-XReport Type:Periodic Company Report #USA031050689 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Health Zyprexa-Oral Initial or Prolonged Jaundice Professional (Olanzapine) Prescribed Overdose (Olanzapine) PS 40 MG/DAY 1 WK Allegra (Fexofenadine Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Date:05/26/04ISR Number: 4367715-5Report Type:Periodic Company Report #USA031050462 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Consumer Zyprexa-Oral Initial or Prolonged Drug Hypersensitivity (Olanzapine) Dyspnoea (Olanzapine) PS 10 MG/AT Dystonia BEDTIME Hallucination, Auditory Benadryl Headache (Diphenhydramine Lethargy Hydrochloride) C Mood Swings Vicodin C Somnolence Ambien (Zolpidem Tartrate) C Depakote (Valproate Semisodium) C Multivitamins Nos (Multivitamins Nos) C Conazepam C Atenolol C 24-Jun-2005 12:19 PM Page: 2914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dilantin (Phenytoin Sodium) C Date:05/26/04ISR Number: 4367716-7Report Type:Periodic Company Report #USA031048845 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Other Company (Olanzapine) PS Representative Abilify (Aripiprazole) C Date:05/26/04ISR Number: 4367717-9Report Type:Periodic Company Report #USA031048735 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-Oral Initial or Prolonged Dyskinesia (Olanzapine) Middle Insomnia (Olanzapine) PS 10 MG Movement Disorder Prozac-Oral Suicidal Ideation (Fluoxetine) Weight Increased (Fluoxetine Hydrochloride) SS Effexor-Xr (Venlafaxine Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Date:05/26/04ISR Number: 4367718-0Report Type:Periodic Company Report #USA030948649 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Zyprexa-Oral Initial or Prolonged Intentional Misuse Professional (Olanzapine) Tachycardia Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4367721-0Report Type:Periodic Company Report #USA030948547 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 10 MG Representative Celexa (Citalopram Hydrobromide) C Date:05/26/04ISR Number: 4367722-2Report Type:Periodic Company Report #USA030948461 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Zyprexa-Oral Initial or Prolonged Fall Professional (Olanzapine) Orthostatic Hypotension (Olanzapine) PS 2.5 MG/DAY 24-Jun-2005 12:19 PM Page: 2915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nadolol C Date:05/26/04ISR Number: 4367723-4Report Type:Periodic Company Report #USA030948324 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) Confusional State Company (Olanzapine) PS 15 MG/DAY 2 MON Dystonia Representative Aspirin C Hallucination Colace (Docusate Hallucination, Visual Sodium) C Lethargy Lisinopril C Muscle Rigidity Tetracycline C Paranoia Vitamins Nos C Urinary Tract Infection Date:05/26/04ISR Number: 4367798-2Report Type:Periodic Company Report #USA040361307 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Zydis-Disper Initial or Prolonged Hallucinations, Mixed Health sible (Olanzapine) Hunger Professional (Olanzapine) PS 5 MG/2 DAY Intentional Self-Injury Strattera Psychomotor Hyperactivity (Atomoxetine Suicidal Ideation Hydrochloride) SS 25 MG Weight Increased Depakote (Valproate Semisodium) C Celexa (Citalopram Hydrobromide) C Ritalin (Methylphenidate Hydrochloride) C Date:05/26/04ISR Number: 4367800-8Report Type:Periodic Company Report #USA040361621 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Disorientation Health Zyprexa-Oral Hospitalization - Dry Mouth Professional (Olanzapine) Initial or Prolonged Overdose Company (Olanzapine) PS 450 MG Respiratory Failure Representative Date:05/26/04ISR Number: 4367801-XReport Type:Periodic Company Report #USA040360978 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Hyperglycaemia Company (Olanzapine) PS 11 YR Representative 24-Jun-2005 12:19 PM Page: 2916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4367802-1Report Type:Periodic Company Report #USA040360918 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 10 MG/EVERY DAY 2 MON Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG Date:05/26/04ISR Number: 4367803-3Report Type:Periodic Company Report #USA040360889 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 5 MG Provigil (Modafinil) C Lexapro (Escitalopram) C Date:05/26/04ISR Number: 4367804-5Report Type:Periodic Company Report #USA040360781 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Dyspnoea Professional (Olanzapine) Other Hyponatraemia (Olanzapine) PS 50 MG/1 AT Loss Of Consciousness BEDTIME Prescribed Overdose Cogentin (Benzatropine Besilate) C Vitamin E C Multivitamin C Synthroid (Levothyroxine Sodium) C Casanthranol W/Docusate Sodium C Haldol (Haloperidol) C Paxil (Paroxetine Hydrochloride) C Date:05/26/04ISR Number: 4367805-7Report Type:Periodic Company Report #USA040360775 Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Hyponatraemia Incontinence Loss Of Consciousness Mydriasis Neurological Examination Abnormal Prescribed Overdose Pupillary Reflex Impaired 24-Jun-2005 12:19 PM Page: 2917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 50 MG/1 DAY Cogentin (Benzatropine Mesilate) C Vitamin E C Prevacid (Lansoprazole) C Celebrex (Celecoxib) C Premarin (Estrogens Conjugated) C Synthroid (Levothyroxine Sodium) C Vitamin D C Colace (Docusate Sodium) C Haldol(Haloperidol) C Multivitamin C Date:05/26/04ISR Number: 4367806-9Report Type:Periodic Company Report #USA040360742 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Drug Ineffective Professional (Olanzapine) Company (Olanzapine) PS 5 MG/1 DAY Representative .. SS Zoloft (Sertraline Hydrochloride) C Date:05/26/04ISR Number: 4367807-0Report Type:Periodic Company Report #USA040360551 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG DAY 3 DAY Representative Date:05/26/04ISR Number: 4367808-2Report Type:Periodic Company Report #USA040360465 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Consumer Zyprexa-Oral Initial or Prolonged Nervousness (Olanzapine) Other Rash Pruritic (Olanzapine) PS 10 MG/2 DAY 24-Jun-2005 12:19 PM Page: 2918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4367809-4Report Type:Periodic Company Report #USA031253522 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4367810-0Report Type:Periodic Company Report #USA031153398 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Consumer Zyprexa-Oral Initial or Prolonged Company (Olanzapine) Representative (Olanzapine) PS Date:05/26/04ISR Number: 4367811-2Report Type:Periodic Company Report #USA031153332 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus (Olanzapine) Pollakiuria (Olanzapine) PS 15 MG/DAY Thirst Date:05/26/04ISR Number: 4367812-4Report Type:Periodic Company Report #USA031153143 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Consumer Zyprexa-Oral Initial or Prolonged Bedridden (Olanzapine) Difficulty In Walking (Olanzapine) PS 5 MG Dysstasia Indocin Incontinence (Indometacin) C Muscle Rigidity Celebrex (Celecoxib) C Neuroleptic Malignant Sinemet C Syndrome Cogentin Parkinsonism (Benzatropine Speech Disorder Mesilate) C Dantrolene C Muscle Relaxant C Date:05/26/04ISR Number: 4367813-6Report Type:Periodic Company Report #USA031152975 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative 24-Jun-2005 12:19 PM Page: 2919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4367814-8Report Type:Periodic Company Report #USA031152306 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zyprexa-Oral Initial or Prolonged Intentional Misuse Professional (Olanzapine) Suicide Attempt Company (Olanzapine) PS 10 MG/DAY 1 WK Representative Paxil (Paroxetine Hydrochloride) C Klonopin (Clonazepam) C Date:05/26/04ISR Number: 4367815-XReport Type:Periodic Company Report #USA031152204 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-Oral Initial or Prolonged Increased Appetite (Olanzapine) Other Mania (Olanzapine) PS 15 MG Suicidal Ideation Prozac-Oral Weight Increased (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG Depakote (Valproate Semisodium) C Antidepressant C Date:05/26/04ISR Number: 4367816-1Report Type:Periodic Company Report #USA031151559 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Date:05/26/04ISR Number: 4367817-3Report Type:Periodic Company Report #USA031151361 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS 20 MG/DAY Date:05/26/04ISR Number: 4367818-5Report Type:Periodic Company Report #USA031051309 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Pancreatitis Company (Olanzapine) PS Representative Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 2920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4369553-6Report Type:Periodic Company Report #USA040260419 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4369555-XReport Type:Periodic Company Report #USA040260334 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Topamax (Topiramate_ C Date:05/26/04ISR Number: 4369557-3Report Type:Periodic Company Report #USA040260209 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa-Oral Initial or Prolonged Convulsion Professional (Olanzapine) Other Head Injury Company (Olanzapine) PS Representative Depakote (Valproate Semisodium) C Date:05/26/04ISR Number: 4369573-1Report Type:Periodic Company Report #USA040260154 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 7.5 MG/3 DAY Representative Date:05/26/04ISR Number: 4369589-5Report Type:Periodic Company Report #USA040260013 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Company Zyprexa Hospitalization - Flat Affect Representative Zydis-Dispersible Initial or Prolonged Lethargy (Olanzapine) Other Restlessness (Olanzapine) PS 7.5 MG DAY Somnolence Celexa (Citalopram Suicide Attempt Hydrochloride) C Thinking Abnormal Fluoxetine C 24-Jun-2005 12:19 PM Page: 2921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4369592-5Report Type:Periodic Company Report #USA040259939 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Zyprexa-Oral Hospitalization - Intentional Misuse Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 5 MG/DAY Representative Premarin (Estrogens Conjugated) C Lasix (Furosemide) C K-Dur Potassium C Synthroid (Levothyroxine Sodium) C Vioxx (Rofecoxib) C Coumadin (Warfarin Sodium) C Zaroxolyn (Metolazone) C Morphine C Vitamin B12 C Hyzaar C Date:05/26/04ISR Number: 4369594-9Report Type:Periodic Company Report #USA040259314 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Zyprexa-Oral Initial or Prolonged Fear (Olanzapine) Hallucination, Visual (Olanzapine) PS 5 MG/DAY Mental Status Changes Depakote (Valproate Panic Attack Semisodium) C Paranoia Xanax (Alprazolam) C Urinary Tract Infection Apo-Metoprolol (Metoprolol Tartrate) C Zantac (Ranitidine Hydrochloride) C Potassium C Norvasc (Amlodiipine Besilate) C Mvi (Mvi) C Penta-Triamterene Hctz C Peri-Colace C Nitroquick (Glyceryl Trinitrate) C Ambien (Zolpidem Tartrate) C Date:05/26/04ISR Number: 4369603-7Report Type:Periodic Company Report #USA040259216 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Prozac-Oral Hospitalization - Weight Increased Professional (Fluoxetine) Initial or Prolonged Company (Fluoxetine Representative Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) 24-Jun-2005 12:19 PM Page: 2922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS 5 MG/DAY Seroquel (Quetiapine Fumarate) C Date:05/26/04ISR Number: 4369609-8Report Type:Periodic Company Report #USA040259188 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Zyprexa-Oral Initial or Prolonged Difficulty In Walking Professional (Olanzapine) Other Oedema Peripheral (Olanzapine) PS Pain In Extremity Klonopin Weight Increased (Clonazepam) C Depakote (Valproate Semisodium) C Motrin (Ibuprofen) C Celebrex (Celecoxib) C Risperdal (Risperidone) C Lithium C Clozaril (Clozapine) C Trileptal (Oxcarbazepine) C Tegretol (Carbamazepine) C Ativan (Lorazepam) C Date:05/26/04ISR Number: 4369613-XReport Type:Periodic Company Report #USA040258832 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other (Olanzapine) PS 10 MG/DAY Risperidone C Zoloft (Sertraline Hydrochloride) C Trazodone C Date:05/26/04ISR Number: 4369632-3Report Type:Periodic Company Report #USA040362933 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Zyprexa-Oral Initial or Prolonged Feeling Abnormal (Olanzapine) Other Grand Mal Convulsion (Olanzapine) PS 20 MG DAY Head Injury Hospitalisation Road Traffic Accident Somnolence Date:05/26/04ISR Number: 4369644-XReport Type:Periodic Company Report #USA040362899 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Blood Glucose Increased Health Initial or Prolonged Weight Increased Professional Other Company 24-Jun-2005 12:19 PM Page: 2923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Depakote(Valproate Semisodium) C Date:05/26/04ISR Number: 4369651-7Report Type:Periodic Company Report #USA040362885 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Weight Increased Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4369653-0Report Type:Periodic Company Report #USA040362695 Age:28 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Health Zyprexa-Oral Hospitalization - Consciousness Professional (Olanzapine) Initial or Prolonged Overdose Company (Olanzapine) PS 10 MG/2 DAY Other Representative Date:05/26/04ISR Number: 4369656-6Report Type:Periodic Company Report #USA040362471 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Humulin-Human Initial or Prolonged Delirium Insulin(Rdna) 30% Hallucination, Visual Regular, 70% Nph( PS 34 U/DAY Zyprexa-Oral(Olanzap ine) (Olanzapine) SS 2.5 MG/1 DAY Marplan(Isocarboxazi d) C Furosemide C Atenolol C Norvasc(Amlodipine Besilate) C Date:05/26/04ISR Number: 4369657-8Report Type:Periodic Company Report #USA040362439 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 2924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4369661-XReport Type:Periodic Company Report #USA040362395 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Company Zyprexa-Oral Weight Increased Representative (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4369663-3Report Type:Periodic Company Report #USA040362344 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged (Olanzapine) PS Other Date:05/26/04ISR Number: 4369665-7Report Type:Periodic Company Report #USA040362257 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Hyperosmolar State Professional (Olanzapine) Company (Olanzapine) PS 4 WK Representative Lithium C Depakote C Date:05/26/04ISR Number: 4369669-4Report Type:Periodic Company Report #USA040362211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Health Zyprexa-Oral Pulmonary Embolism Professional (Olanzapine) Swelling Company (Olanzapine) PS Weight Increased Representative Date:05/26/04ISR Number: 4369869-3Report Type:Periodic Company Report #USA040258272 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Loss Of Consciousness Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4369871-1Report Type:Periodic Company Report #USA040258101 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa-Oral Initial or Prolonged Consciousness Professional (Olanzapine) Company (Olanzapine) PS 15 MG Representative 24-Jun-2005 12:19 PM Page: 2925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4369873-5Report Type:Periodic Company Report #USA040157979 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa-Oral Initial or Prolonged Dysarthria Professional (Olanzapine) Hypokalaemia Company (Olanzapine) PS 10 MG Hyponatraemia Representative Mellaril (Thioridazine Hydrochloride) C Date:05/26/04ISR Number: 4369875-9Report Type:Periodic Company Report #USA040157008 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Agitation Professional (Olanzapine) Alanine Aminotransferase (Olanzapine) PS 1000 MG Increased Valproic Acid C Aspartate Paxil (Paroxetine Aminotransferase Hydrochloride) C Increased Body Temperature Increased Hypotension Intentional Misuse Mental Impairment Prescribed Overdose Tachycardia White Blood Cell Count Decreased Date:05/26/04ISR Number: 4369877-2Report Type:Periodic Company Report #USA040156759 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Misuse Health Zyprexa-Oral Hospitalization - Suicide Attempt Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 2.5 MG/DAY Representative Synthroid (Levothyroxide Sodium) C Date:05/26/04ISR Number: 4369879-6Report Type:Periodic Company Report #USA040156668 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Consumer Zyprexa-Oral Initial or Prolonged Fatigue (Olanzapine) Hypersomnia (Olanzapine) PS UNKNOWN UNK 1 DAY Date:05/26/04ISR Number: 4369881-4Report Type:Periodic Company Report #USA040156251 Age:9 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Anger Crying 24-Jun-2005 12:19 PM Page: 2926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Ineffective Mood Swings Tic Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Strattera (Atomoxetine Hydrochloride) PS 60 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/IN THE MORNING Abilify (Aripiprazole) C Trileptal (Oxcarbazepine) C Seroquel (Quetiapine Fumarate) C Lexapro (Escitalopram) C Singulair (Montelukast Sodium) C Date:05/26/04ISR Number: 4369884-XReport Type:Periodic Company Report #USA040156134 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 20 MG/DAY Representative Zoloft (Sertraline Hydrochloride) C Date:05/26/04ISR Number: 4369885-1Report Type:Periodic Company Report #USA040155794 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine) Suicide Attempt (Olanzapine) PS 20 MG/DAY Weight Increased Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 3 WK Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Lithium C Zoloft (Sertraline Hydrochloride) C Date:05/26/04ISR Number: 4369886-3Report Type:Periodic Company Report #USA031255435 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa Initial or Prolonged Paranoia Zydis-Dispersible Prescribed Overdose (Olanzapine) Suicidal Ideation (Olanzapine) PS 80 MG/DAY Risperdal 24-Jun-2005 12:19 PM Page: 2927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) C Plavix (Clopidogrel Sulfate) C Protonix (Pantoprazole) C Lexapro (Escitalopram) C Abilify (Aripiprazole) C Prevacid (Lansoprazole) C Date:05/26/04ISR Number: 4369977-7Report Type:Periodic Company Report #USA031255386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fluid Retention Health Zyprexa-Oral Initial or Prolonged Mania Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 5 MG/DAY 2 WK Representative Prozac (Fluoxetine Hydrochloride) C Hydrocodone W/Acetaminophen C Date:05/26/04ISR Number: 4369980-7Report Type:Periodic Company Report #USA031255271 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Health Zyprexa-Oral Initial or Prolonged Hormone Decreased Professional (Olanzapine) Diabetic Ketoacidosis Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4369985-6Report Type:Periodic Company Report #USA031255194 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Zyprexa-Oral Initial or Prolonged Intentional Misuse Professional (Olanzapine) Company (Olanzapine) PS 30 MG 1 DAY Representative Date:05/26/04ISR Number: 4370019-8Report Type:Periodic Company Report #USA031255192 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Suicide Attempt Professional (Olanzapine) Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4370021-6Report Type:Periodic Company Report #USA031255071 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Health Zyprexa-Oral Initial or Prolonged Priapism Professional (Olanzapine) 24-Jun-2005 12:19 PM Page: 2928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS 10 MG/2 DAY Paxil (Paroxetine Hydrochloride) C Remeron (Mirtazapine) C Date:05/26/04ISR Number: 4370025-3Report Type:Periodic Company Report #USA031254914 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Urea Increased Health Zyprexa-Oral Hyperglycaemia Professional (Olanzapine) Polydipsia Company (Olanzapine) PS 10 MG/2 DAY Polyuria Representative Dyazide C Weight Increased Date:05/26/04ISR Number: 4370027-7Report Type:Periodic Company Report #USA031254658 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Health Zyprexa-Oral Initial or Prolonged Psychiatric Symptom Professional (Olanzapine) (Olanzapine) PS 30 MG/DAY Date:05/26/04ISR Number: 4370028-9Report Type:Periodic Company Report #USA031254590 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Consumer Humulin-Human Initial or Prolonged Staphylococcal Infection Regular Insulin Other Urinary Tract Infection (Rdna) (Human Insulin PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS 15 MG/AT BEDTIME Lantus (Insulin Glargine) C Risperdal (Risperidone) C Date:05/26/04ISR Number: 4370030-7Report Type:Periodic Company Report #USA031253707 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Date:05/26/04ISR Number: 4370032-0Report Type:Periodic Company Report #USA031253661 Age:65 YR Gender: I/FU:I Outcome PT Report Source Hospitalization - Loss Of Consciousness Health Initial or Prolonged Professional Other Company 24-Jun-2005 12:19 PM Page: 2929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4373068-9Report Type:Expedited (15-DaCompany Report #2004031917 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Ziprasidone (Caps) Hospitalization - Health (Ziprasidone) PS ORAL ORAL 1 WK Initial or Prolonged Professional Olanzapine (Olanzapine) SS ORAL ORAL Antidepressants (Antidepressants) C Lithium Carbonate (Lithium Carbonate) C Anxiolytics (Anxiolytics) C Date:05/26/04ISR Number: 4383011-4Report Type:Periodic Company Report #USA030126319 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa Initial or Prolonged Diabetic Ketoacidosis Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS 5 MG DAY 1 MON Date:05/26/04ISR Number: 4383012-6Report Type:Periodic Company Report #USA020718316 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa-Oral Cognitive Disorder (Olanzapine) Coordination Abnormal (Olanzapine) PS 15 MG/DAY Depression Depakote (Valproate Difficulty In Walking Semisodium) C Fall Dilantin (Phenytoin Gingival Hypertrophy Sodium) C Grand Mal Convulsion Benadryl Hallucination, Auditory (Diphenhydramine Herpes Simplex Hydrochloride) C Lethargy Tenex (Guanfacine Motor Dysfunction Hydrochloride) C Psychotic Disorder Social Avoidant Behaviour Speech Disorder Tremor Weight Decreased Weight Increased 24-Jun-2005 12:19 PM Page: 2930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4383013-8Report Type:Periodic Company Report #USA021023190 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Zyprexa-Oral Pancreatitis Acute Professional (Olanzapine) Pneumonia Company (Olanzapine) PS Representative Date:05/26/04ISR Number: 4383014-XReport Type:Periodic Company Report #US_020988349 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Health Zyprexa-Oral Initial or Prolonged Blood Potassium Decreased Professional (Olanzapine) Lethargy (Olanzapine) PS Mental Impairment Parkinsonism Pyrexia Urinary Tract Infection Date:05/26/04ISR Number: 4383015-1Report Type:Periodic Company Report #US_010770104 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Humulin-Human Nph Initial or Prolonged Anxiety Insulin (Rdna) Other Asthma (Human Insulin (Rd PS 80 U/DAY Blood Glucose Increased Prozac-Oral Blood Thyroid Stimulating (Fluoxetine) Hormone Decreased (Fluxoetine Depression Hydrochloride) SS Diarrhoea Zyprexa-Oral Eating Disorder (Olanzapine) Goitre (Olanzapine) SS Hair Texture Abnormal Phentermine C Hallucination Pondimin Headache (Fenfluramine Hypothyroidism Hydrochloride) C Insulin Resistance Levothyroxine C Iodine Allergy Armour Thyroid Iron Metabolism Disorder (Thyroid) C Lower Limb Fracture Glucophage Mental Disorder (Metformin Nausea Hydrochloride) C Negativism Avandia Pain (Rosiglitazone Palpitations Maleate) C Pernicious Anaemia Vitamins C Pharyngolaryngeal Pain Magnesium C Road Traffic Accident Chromium C Skin Ulcer Redux Stomach Discomfort (Dexfenfluramine Thyroid Neoplasm Hydrochloride) C Vomiting Novolin (Insulin Weight Decreased Human Injection, Weight Increased Isophane) C Seroquel (Quetiapine Fumarate) C Prozac (Fluoxetine 24-Jun-2005 12:19 PM Page: 2931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:05/26/04ISR Number: 4383016-3Report Type:Periodic Company Report #US_010769970 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Prozac-Oral Initial or Prolonged Depression (Fluoxetine) Drug Effect Decreased (Fluoxetine Drug Ineffective Hydrochloride) PS 40 MG/DAY Schizophrenia Prozac Weekly-Weekly Somnolence (Once A Week Formulation) (Flu SS 90 MG/1 WEEK 1 MON Zyprexa-Oral (Olanzapine) (Olanzapine) SS 15 MG/DAY 2 MON Risperdal (Risperidone) C Date:05/26/04ISR Number: 4383017-5Report Type:Periodic Company Report #US_010668260 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Consumer Zyprexa (Olanzapine) PS 20 MG/1 DAY Initial or Prolonged Schizophrenia Weight Increased Date:05/26/04ISR Number: 4383018-7Report Type:Periodic Company Report #USA040363386 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Health Zyprexa-Dispersible Initial or Prolonged Joint Swelling Professional (Olanzapine) Company (Olanzapine) PS 15 MG DAY Representative High Blood Pressure C Diuretic C Date:05/26/04ISR Number: 4383019-9Report Type:Periodic Company Report #USA040363356 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) Other (Olanzapine) PS Date:05/26/04ISR Number: 4383020-5Report Type:Periodic Company Report #USA040363246 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Dysphonia (Olanzapine) Hyperkinesia (Olanzapine) PS 5 MG DAY 4 MON Sydenham'S Chorea Strattera Tardive Dyskinesia (Atomoxetine Vocal Cord Thickening Hydrochloride) SS 40 MG DAY Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 2932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Lorazepam C Klonopin (Clonazepam) C Date:05/26/04ISR Number: 4383021-7Report Type:Periodic Company Report #USA040363244 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Consumer Zyprexa-Oral Other Delirium (Olanzapine) Increased Appetite (Olanzapine) PS 7.5 MG/DAY Weight Increased Lexapro (Escitalopram) C Digoxin C Protonix (Pantoprazole) C Lorazepam C Valium (Diazepam) C Date:05/26/04ISR Number: 4383022-9Report Type:Periodic Company Report #USA040363087 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Zyprexa-Oral Initial or Prolonged Lung Disorder Professional (Olanzapine) (Olanzapine) PS 5 MG Aricept (Donepezil Hydrochloride) C Date:05/26/04ISR Number: 4383023-0Report Type:Periodic Company Report #USA040363081 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Consumer Zyprexa-Oral Hospitalization - Difficulty In Walking (Olanzapine) Initial or Prolonged Drug Ineffective (Olanzapine) PS 30 MG DAY Faecaloma Methadone C Hypersomnia Clonazepam C Oedema Peripheral Pain Pain In Extremity Pneumonia Prescribed Overdose Pyrexia Sepsis Sinus Tachycardia Urinary Tract Infection Weight Increased Date:05/26/04ISR Number: 4383024-2Report Type:Periodic Company Report #US_0403101897 Age:50 YR Gender:Female I/FU:I Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 2933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Zyprexa-Oral Aggression (Olanzapine) Anger (Olanzapine) PS 30 MG DAY Convulsion Mellaril Depression Suicidal (Thioridazine Gun Shot Wound Hydrochloride) C Personality Change Advair C Prescribed Overdose Clonezepam C Visual Acuity Reduced Phenytoin C Ambien (Zolpidem Tartrate) C Protonix (Pantoprazole) C Combivent C Methocarbamol C Hydrocodone W/Apap C Famotidine C Zanaflex (Tizanidine Hydrochloride) C Diazepam C Belladonna Alkaloids C Carisoprodol C Atropine W/Diphenoxylate C Sulfamethoxazole W/Trimethoprim C Skelaxin (Metaxalone) C Amoxicillin C Propoxyphene C Tetracycline C Tylenol W/Codeine No. 3 C Metoclopramide C Neurontin (Gabapentin) C Temazepam C Zithromax (Azithromycin) C Albuterol C Tequin (Azithromycin) C Wellbutrin Sr (Bupropion Hydrochloride) C Chlorpromazine C Nicotrol (Nicotine) C Ultram (Tramadol Hydrochloride) C Lorazepam C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Trazadone (Trazodone) C Seroquel (Quetiapine Fumarate) C Ketorolac C 24-Jun-2005 12:19 PM Page: 2934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Diflucan (Fluconazole) C Premphase C Hyoscyamine C Dicyclomine (Dicycloverine) C Tizanidine C Vioxx (Rofecoxib) C Date:05/26/04ISR Number: 4383025-4Report Type:Periodic Company Report #US_0403101761 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4383026-6Report Type:Periodic Company Report #US_0403101750 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4383027-8Report Type:Periodic Company Report #US_0403101749 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4383028-XReport Type:Periodic Company Report #US_0403101748 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4383029-1Report Type:Periodic Company Report #US_0403101703 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Orthostatic Hypotension Health Olanzapine-Oral Hospitalization - Overdose Professional (Olanzapine) PS 2.5 MG/1 DAY Initial or Prolonged Somnolence Company Remeron Suicide Attempt Representative (Mirtazapine) C Actos (Pioglitazone) C Apresoline (Hydralazine Hydrochloride) C Zocor (Simvastatin) C 24-Jun-2005 12:19 PM Page: 2935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4383030-8Report Type:Periodic Company Report #US_0403101321 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Health Zyprexa-Oral Disability Increased Professional (Olanzapine) Other Blood Glucose Increased (Olanzapine) PS 20 MG/2 DAY Blood Triglycerides Lexapro Increased (Escitalopram) C Lipitor (Atorvastatin) C Enalapril C Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Clonazepam C Avandamet C Date:05/26/04ISR Number: 4383031-XReport Type:Periodic Company Report #US_031299542 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Zyprexa-Oral Initial or Prolonged Other (Olanzapine) (Olanzapine) PS Methadone C Date:05/26/04ISR Number: 4383032-1Report Type:Periodic Company Report #US_031299267 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:05/26/04ISR Number: 4383033-3Report Type:Periodic Company Report #US_030695164 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Consumer Zyprexa-Oral Initial or Prolonged Erectile Dysfunction (Olanzapine) (Olanzapine) PS 5 MG/AT BEDTIME Vitamins Nos C Wellbutrin (Bupropion Hydrochloride) C Date:05/27/04ISR Number: 4366025-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591889 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Aripiprazole PS Otsuka Drug Interaction Professional Pharmaceutical Paranoia Company, Ltd. ORAL Olanzapine I 24-Jun-2005 12:19 PM Page: 2936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4367017-7Report Type:Direct Company Report #CTU 219670 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Olanzapine PS Initial or Prolonged Non-Insulin-Dependent Diabetic Ketoacidosis Date:05/27/04ISR Number: 4368826-0Report Type:Expedited (15-DaCompany Report #US_0405102894 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Zyprexa-Oral Initial or Prolonged Coma Professional (Olanzapine) Drug Abuser (Olanzapine) PS Electrocardiogram St-T Lexapro Segment Abnormal (Escitalopram) C Loss Of Consciousness Depakote (Valproate Multiple Drug Overdose Semisodium) C Self-Medication Cocaine C Alcohol C Date:05/27/04ISR Number: 4368884-3Report Type:Expedited (15-DaCompany Report #USA021022336 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa-Oral Hospitalization - Confusional State Professional (Olanzapine) Initial or Prolonged Diabetic Coma Company (Olanzapine) PS 15 MG/DAY Other Food Craving Representative Lithium C Gait Disturbance Glycosylated Haemoglobin Increased Psychotic Disorder Somnolence Suicidal Ideation Thirst Urinary Incontinence Date:05/27/04ISR Number: 4368887-9Report Type:Expedited (15-DaCompany Report #USA021123575 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) Other Rhabdomyolysis Company (Olanzapine) PS 2.5 MG /AT Representative BEDTIME Naproxen C Date:05/27/04ISR Number: 4369144-7Report Type:Expedited (15-DaCompany Report #USA040362471 Age:75 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Blood Glucose Increased Confusional State Delirium Disorientation 24-Jun-2005 12:19 PM Page: 2937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrolyte Imbalance Hallucination, Visual Infection Report Source Product Role Manufacturer Route Dose Duration Consumer Humulin-Human Health Insulin (Rdna) :30% Professional Regular, 70% Nph (H PS 34 U/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/1 IN THE EVENING Marplan (Isocarboxazid) C Furosemide C Atenolol C Protonix (Pantoprazole) C Lipitor (Atorvastatin) C Avapro (Irbesartan) C Isordil (Isosorbide Dinitrate) C Robitussin (Guaifenesin) C Zithromax (Azithromycin) C Ceftriaxone C Norvasc(Amlodipine Besylate) C Date:05/27/04ISR Number: 4369169-1Report Type:Expedited (15-DaCompany Report #US_0405103070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Consumer Zyprexa-Oral Initial or Prolonged Living Impaired (Olanzapine) Disability Arthritis (Olanzapine) PS Other Autonomic Neuropathy Chronic Obstructive Pulmonary Disease Diabetes Mellitus Diabetic Neuropathy Hepatitis C Hypothyroidism Incontinence Skin Ulcer Date:05/27/04ISR Number: 4369389-6Report Type:Expedited (15-DaCompany Report #USA040567263 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Blindness Transient Other Blood Pressure Decreased Convulsion Diabetes Mellitus Dyspepsia Hypoaesthesia Loss Of Consciousness Nausea 24-Jun-2005 12:19 PM Page: 2938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Vision Blurred Visual Acuity Reduced Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Consumer Prozac-Oral Weight Increased (Fluoxetine) (Fluoxetine Hydrochloride) PS 80 MG/DAY 6 YR Humulin-Human Insulin (Rdna): 30% Regular, 70% Nph (H SS 78 U DAY Humalog-, (Lispro) SS Zyprexa-Oral (Olanzapine) (Olanzapine) SS Dilantin (Phenytoin Sodium) C Tegretol (Carbamazepine) C Risperidone C Ativan (Lorazepam) C Vioxx (Rofecoxib) C Centrum A To Zinc C Date:05/27/04ISR Number: 4369398-7Report Type:Expedited (15-DaCompany Report #USA040567240 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Prozac-Oral Initial or Prolonged Increased Professional (Fluoxetine) Other Blood Glucose Increased Company (Fluoxetine High Density Lipoprotein Representative Hydrochloride) PS 20 MG IN THE Decreased MORNING Low Density Lipoprotein Zyprexa-Oral Increased (Olanzapine) (Olanzapine) SS 15 MG AT BEDTIME Norvasc (Amlodipine Besilate) C Hydrochlorothiazide/ Triamterene C Clonidine C Risperdal (Risperidone) C Date:05/27/04ISR Number: 4369448-8Report Type:Expedited (15-DaCompany Report #USA040567095 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine Company (Olanzapine) PS 20 MG DAY Representative 24-Jun-2005 12:19 PM Page: 2939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4369450-6Report Type:Expedited (15-DaCompany Report #USA040567060 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Other Pulmonary Oedema Professional (Olanzapine) Company (Olanzapine) PS UNKNOWN UNK Representative Abilify (Aripiprazole) C Date:05/27/04ISR Number: 4369451-8Report Type:Expedited (15-DaCompany Report #USA040566988 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Zyprexa-Oral Initial or Prolonged Chest Pain Professional (Olanzapine) Disorientation (Olanzapine) PS 30 MG/1 DAY 1 DAY Respiratory Distress Ativan (Lorazepam) C Soliloquy Depakote (Valproate Semisodium) C .... C Date:05/27/04ISR Number: 4369454-3Report Type:Expedited (15-DaCompany Report #USA040566907 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Zyprexa-Rapid-Acting Cerebrovascular Accident Professional Im (Olanzapine) PS 5 MG Company Representative Date:05/27/04ISR Number: 4369455-5Report Type:Expedited (15-DaCompany Report #USA030741976 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Zyprexa-Oral Initial or Prolonged Screaming Professional (Olanzapine) Treatment Noncompliance (Olanzapine) PS 10 MG/2 DAY Tremor Zyprexa Weight Increased Zydis-Dispersible (Olanzapine) (Olanzapine) SS 10 MG/2 DAY Trazadone C Topamax (Topiramate) C Date:05/27/04ISR Number: 4369619-0Report Type:Expedited (15-DaCompany Report #US_031299506 Age:26 YR Gender:Male I/FU:F Outcome PT Death Accident Other Blood Alcohol Increased Dehydration Delusion Diabetic Hyperosmolar Coma Drug Toxicity Electrolyte Imbalance Fear 24-Jun-2005 12:19 PM Page: 2940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucinations, Mixed Hyperglycaemia Pulmonary Congestion Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Date:05/27/04ISR Number: 4369621-9Report Type:Expedited (15-DaCompany Report #USA040155894 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Zyprexa-Oral Anorexia Health (Olanzapine) Antisocial Behaviour Professional (Olanzapine) PS 2 WK Blood Pressure Increased Strattera Capillary Disorder (Atomoxetine Cyanosis Hydrochloride) SS 60 MG DAY Dizziness Depakote (Valproate Erythema Semisodium) C Feeling Cold Tegretal Homicidal Ideation (Carbamazepine) C Hypoventilation Pulse Absent Tachycardia Date:05/27/04ISR Number: 4369622-0Report Type:Expedited (15-DaCompany Report #USA040259861 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Myocardial Infarction Professional (Olanzapine) Other Weight Increased (Olanzapine) PS 30 MG/1 AT BEDTIME Haldol (Haloperidol) SS Lipitor (Atorvastatin) SS Benadryl (Diphenhydramine Hydrochloride) C Toprol Xl (Metoprolol Succinate) C Zoloft (Sertraline Hydrochloride) C Date:05/27/04ISR Number: 4369882-6Report Type:Expedited (15-DaCompany Report #EWC040539176 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa-Oral(Olanzap Initial or Prolonged Syndrome Health ine) (Olanzapine) PS 15 MG/1 DAY 1 YR Professional Efexor (Venlafaxine Other Hydrochloride) C Nozinan (Levomepromazine) C 24-Jun-2005 12:19 PM Page: 2941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4369883-8Report Type:Expedited (15-DaCompany Report #EWC040539177 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Drug Level Increased Health (Olanzapine) Feeling Abnormal Professional (Olanzapine) PS 10 MG/1 DAY Left Ventricular Failure Other Pulmonary Oedema Date:05/27/04ISR Number: 4369894-2Report Type:Expedited (15-DaCompany Report #EWC040539180 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Overdose Health (Olanzapine) PS Professional Other Date:05/27/04ISR Number: 4369901-7Report Type:Expedited (15-DaCompany Report #JP_040403035 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Zyprexa-Oral Initial or Prolonged Autoimmune Health (Olanzapine)(Olanzap Cold Agglutinins Professional ine) PS 15 MG DAY Dizziness Postural Company Silece Hypoaesthesia Representative (Flunitrazepam) C Jaundice Other Contomin Laboratory Test Abnormal (Chlorpromazine Pallor Hydrochloride) C Platelet Count Increased Biperiden C Pneumonia Pyrexia Date:05/27/04ISR Number: 4369904-2Report Type:Expedited (15-DaCompany Report #CA_040306704 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa -Oral Initial or Prolonged Pulmonary Fibrosis Health (Olanzapine) Somnolence Professional (Olanzapine) PS 2.5 MG AT Company BEDTIME Representative Entrophen Other (Acetylsalicylic Acid) C Lasix (Furosemide) C Coumadin (Warfarin Sodium) C Amatine (Midodrine Hydrochloride) C Desyrel (Trazodone Hydrochloride) C Synthroid (Levothyroxine Sodium) C Pravachol (Pravastatin Sodium) C 24-Jun-2005 12:19 PM Page: 2942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4369906-6Report Type:Expedited (15-DaCompany Report #EWC040438853 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apallic Syndrome Foreign Zyprexa-Oral Life-Threatening Asthenia Health (Olanzapine) PS 2.5 MG/1 DAY Brain Oedema Professional Atenolol C Bundle Branch Block Left Other Enalapril C Cardio-Respiratory Arrest Indapamide C Coma Bromazepam C Confusional State Dorzolamide C Hallucination Timolol C Hypoalbuminaemia Brimonidine C Hypocalcaemia Voltaren (Diclofenac Locked-In Syndrome Sodium) C Quadriplegia Respiratory Failure Tremor Date:05/27/04ISR Number: 4369923-6Report Type:Expedited (15-DaCompany Report #JP_040302836 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Foreign Zyprexa Dehydrogenase Increased Study (Olanzapine) PS 10 MG/1 DAY Hyperprolactinaemia Health Pyrethia Iron Deficiency Anaemia Professional (Promethazine Other Hydrochloride) C Epirenat (Valproate Sodium) C Benzalin (Nitrazepam) C Bicamol (Biperiden Hydrochloride) C Pursennid (Senna Leaf) C Bromocriptine Mesilate C Loxonin (Loxoprofen Sodium) C Serenace (Haloperidol) C Lamisil (Terbinafine Hydrochloride) C Date:05/27/04ISR Number: 4370085-XReport Type:Expedited (15-DaCompany Report #JP_040402973 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Blood Creatinine Professional (Olanzapine) PS 20 MG DAY Increased Company Lullan (Perospirone Blood Urea Increased Representative Hydrochloride) C Electrocardiogram Other Haloperidol Abnormal Decanoate C Grand Mal Convulsion Ankineton (Biperiden Pyrexia Hydrochloride) C Urine Output Increased Restas (Flutoprazepam) C 24-Jun-2005 12:19 PM Page: 2943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Marzulene S C Selbex (Teprenone) C Magnesium Oxide C Gaster (Famotidine) C Date:05/27/04ISR Number: 4370088-5Report Type:Expedited (15-DaCompany Report #GBS040514908 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Olanzapine-Oral Dyspnoea Health (Olanzapine) PS 10 MG Weight Increased Professional Other Date:05/27/04ISR Number: 4370090-3Report Type:Expedited (15-DaCompany Report #GBS040514909 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autonomic Nervous System Foreign Olanzapine-Oral Imbalance Health (Olanzapine) PS 30 MG Blood Creatine Professional Valproic Acid C Phosphokinase Increased Other Diazepam C Cogwheel Rigidity Liver Function Test Abnormal Nervous System Disorder Neuroleptic Malignant Syndrome Prescribed Overdose Pyrexia Date:05/27/04ISR Number: 4370092-7Report Type:Expedited (15-DaCompany Report #FR_040403860 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa PS 10 MG/M2 DAY Initial or Prolonged Loss Of Consciousness Health Prozac-Oral Malaise Professional (Fluoxetine) Company (Fluoxetine Representative Hydrochloride) SS 20 MG/1 DAY Distributor Rivotril Other (Clonazepam) C Tercian (Cyamemazine) C Date:05/27/04ISR Number: 4370093-9Report Type:Expedited (15-DaCompany Report #EWC040539235 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa-Oral Galactorrhoea Health (Olanzapine) Liver Function Test Professional (Olanzapine) PS 10 MG/1 DAY Abnormal Other 24-Jun-2005 12:19 PM Page: 2944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4370095-2Report Type:Expedited (15-DaCompany Report #AU_040507697 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Foreign Zyprexa-Oral Optic Neuropathy Health (Olanzapine) Professional (Olanzapine) PS Other Date:05/27/04ISR Number: 4371024-8Report Type:Expedited (15-DaCompany Report #US_0405102979 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:05/28/04ISR Number: 4367411-4Report Type:Direct Company Report #CTU 219742 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Zyprexa PS Fatigue Weight Increased Date:05/28/04ISR Number: 4367437-0Report Type:Expedited (15-DaCompany Report #12 MAY 2004 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Polytraumatism Study Olanzapine 5 Mg Initial or Prolonged Road Traffic Accident Tablet; Barr Upper Limb Fracture Laboratories, Inc. PS Barr Laboratories, Inc. ORAL 5 MG SINGLE ORAL DOSE Date:06/01/04ISR Number: 4371944-4Report Type:Expedited (15-DaCompany Report #HQWYE039120MAY04 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Effexor (Venlafaxine Initial or Prolonged Insulin-Dependent Hydrochloride, Diabetic Ketoacidosis Unspec) PS ORAL 75 MG 1X PER Weight Increased 1 DAY, ORAL; DOSAGE UNSPECIFED, ORAL 18 MON Olanzapine (Olanzapine, ) SS 5 MG 1X PER 1 DAY 18 MON Valproic Acid (Valproic Acid) SS 1500 MG 1X PER 1 DAY; DOSAGE UNSPECIFIED 18 MON 24-Jun-2005 12:19 PM Page: 2945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/04ISR Number: 4368676-5Report Type:Expedited (15-DaCompany Report #04P-163-0259510-00 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Depakote (Divalproex Initial or Prolonged Depressed Level Of Health Sodium) (Divalproex Consciousness Professional Sodium) PS Electrocardiogram St Other Lexapro Film-Coated Segment Tablets Intentional Misuse (Escitalopram) Self-Medication (Escitalopram) SS ORAL 10 MG, UNKNOWN AMOUNT, ORAL Olanzapine SS Ethanol SS Cocaine SS Date:06/03/04ISR Number: 4372863-XReport Type:Expedited (15-DaCompany Report #US_0405103066 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Prozac-Oral Initial or Prolonged Alcoholism Professional (Fluoxetine) Drug Withdrawal Syndrome Other (Fluoxetine Intentional Self-Injury Hydrochloride) PS 20 MG/1 DAY Memory Impairment Symbyax-Olanzapine Suicidal Ideation 12mg /Fluoxetine Treatment Noncompliance 25mg(Olanzapine SS 22 DAY Lithium Carbonate C Furosemide C Kcl (Potassium Chloride) C Mvi (Mvi) C Date:06/03/04ISR Number: 4373037-9Report Type:Expedited (15-DaCompany Report #USA040567516 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 2.5 MG Trileptal (Oxcarbazepine) C Benadryl (Diphenhydramine Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:06/03/04ISR Number: 4373038-0Report Type:Expedited (15-DaCompany Report #USA040567893 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Health Zyprexa-Oral Initial or Prolonged Thrombocytopenic Purpura Professional (Olanzapine) Other Stevens-Johnson Syndrome (Olanzapine) PS Therapy Non-Responder Lexapro Treatment Noncompliance (Escitalopram) C 24-Jun-2005 12:19 PM Page: 2946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4373039-2Report Type:Expedited (15-DaCompany Report #USA040568027 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adrenal Disorder Health Zyprexa-Rapid-Acting Drug Ineffective Professional Im (Olanzapine) PS Hypoxia Company Oxygen Saturation Representative Decreased Pneumonia Red Blood Cell Sedimentation Rate Increased Renal Disorder Sepsis Vitamin B12 Increased Date:06/03/04ISR Number: 4373048-3Report Type:Expedited (15-DaCompany Report #US_0403101674 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Consumer Zyprexa-Oral Infarction (Olanzapine) (Olanzapine) PS Date:06/03/04ISR Number: 4373049-5Report Type:Expedited (15-DaCompany Report #US_0405103070 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Consumer Zyprexa-Oral Initial or Prolonged Living Impaired (Olanzapine) Disability Arthritis (Olanzapine) PS Other Autonomic Neuropathy Insulin C Chronic Obstructive Glucovance C Pulmonary Disease Diabetes Mellitus Diabetic Neuropathy Hepatitis C Hepatitis Chronic Active Hypothyroidism Skin Ulcer Urinary Incontinence Date:06/03/04ISR Number: 4373164-6Report Type:Expedited (15-DaCompany Report #USA040567240 Age:49 YR Gender:Male I/FU:F Outcome PT Hospitalization - Balance Disorder Initial or Prolonged Blood Cholesterol Other Increased Blood Glucose Increased Confusional State Dizziness Grip Strength Decreased High Density Lipoprotein Decreased Hyperosmolar State Low Density Lipoprotein Increased 24-Jun-2005 12:19 PM Page: 2947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Twitching Oxygen Saturation Decreased Report Source Product Role Manufacturer Route Dose Duration Stupor Health Prozac-Oral Professional (Fluoxetine) Company (Fluoxetine Representative Hydrochloride) PS 20 MG IN THE MORNING Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG IN THE MORNING Norvasc (Amlodipine Besilate) C Hydrochlorothiazide/ Triamterene C Clonidine C Risperdal (Risperidone) C Date:06/03/04ISR Number: 4373170-1Report Type:Expedited (15-DaCompany Report #USA030229610 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa-Oral Blood Glucose Increased Health (Olanzapine) Cardiac Arrest Professional (Olanzapine) PS Confusional State Glucotrol Crying (Glipizide) C Dehydration Insulin C Diet Refusal Drug Ineffective Failure To Thrive General Physical Health Deterioration Malnutrition Multi-Organ Failure Respiratory Arrest Speech Disorder Treatment Noncompliance Date:06/03/04ISR Number: 4373173-7Report Type:Expedited (15-DaCompany Report #USA040464354 Age:62 YR Gender:Male I/FU:F Outcome PT Death Arrhythmia Life-Threatening Cardio-Respiratory Arrest Circulatory Collapse Coronary Artery Occlusion Diarrhoea Drug Level Above Therapeutic Dyspnoea Heart Rate Decreased Mediastinal Haemorrhage Pulmonary Haemorrhage Refusal Of Treatment By Patient Rib Fracture 24-Jun-2005 12:19 PM Page: 2948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa Professional Zydis-Dispersible (Olanzapine) (Olanzapine) PS 10 MG/1 AT BEDTIME Capoten (Captopril) C Lexapro (Escitalopram) C Geodon (Ziprasidone Hydrochloride) C Date:06/03/04ISR Number: 4373742-4Report Type:Expedited (15-DaCompany Report #FR_040504125 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Zyprexa-Oral Other Respiratory Arrest Health (Olanzapine) Professional (Olanzapine) PS 5 MG/1 DAY Other Levothyrox (Levothyroxine Sodium) C Lexomil (Bromazepam) C Ixel (Milnacipran) C Date:06/03/04ISR Number: 4373743-6Report Type:Expedited (15-DaCompany Report #FR_040504124 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS General Physical Health Other Tranxene Deterioration (Clorazepate Inflammation Dipotassium) C Myalgia Sulfarlem (Anethole Trithione) C Zoloft (Sertraline Hydrochloride) C Date:06/03/04ISR Number: 4373975-7Report Type:Expedited (15-DaCompany Report #FR_040504109 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Catatonia Health (Olanzapine) Regressive Behaviour Professional (Olanzapine) PS 10 MG/1 DAY Other Depamine (Valpromide) C Motilium (Domperidone) C Parkinane (Trihexyphenidyl Hydrochloride) C Temesta (Lorazepam) C Rythmol 24-Jun-2005 12:19 PM Page: 2949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Propafenone) C Date:06/03/04ISR Number: 4373982-4Report Type:Expedited (15-DaCompany Report #EWC040539355 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 30 MG DAY Professional Tavor (Lorazepam) C Company Largactil Representative (Chlorpromazine Other Hydrochloride) C Talofen (Promazine Hydrochloride) C Farganesse (Promethazine Hydrochloride) C Date:06/03/04ISR Number: 4373987-3Report Type:Expedited (15-DaCompany Report #EWC040539350 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 10 MG Professional Tavor (Lorazepam) C Company Talofen (Promazine Representative Hydrochloride) C Other Date:06/03/04ISR Number: 4373989-7Report Type:Expedited (15-DaCompany Report #EWC040539310 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Decreased Foreign Zyprexa-Dispersible Cerebrovascular Accident Health (Olanzapine) General Physical Health Professional (Olanzapine) PS 5 MG/2 DAY Deterioration Other Buronil (Melperone Hypertension Hydrochloride) C Reminyl (Galantamine Hydrobromide) C Akineton (Biperiden Hydrochloride) C Date:06/03/04ISR Number: 4373991-5Report Type:Expedited (15-DaCompany Report #GBS040514940 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa-Oral Lower Respiratory Tract Health (Olanzapine) Infection Professional (Olanzapine) PS 20 MG/1 DAY Oxygen Saturation Other Ciprofloxacin C Decreased Haloperidol C Respiratory Rate Zopiclone C Increased Senna C Somnolence Warfarin C Salbutamol C Ipratropium C Beclomethasone C 24-Jun-2005 12:19 PM Page: 2950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mil-Par C Prednisolone C Paracetamol C Codeine C Tinzaparin C Date:06/03/04ISR Number: 4373995-2Report Type:Expedited (15-DaCompany Report #JP_040503182 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Zyprexa-Oral Initial or Prolonged Fall Study (Olanzapine) Femoral Neck Fracture Health (Olanzapine) PS 5 MG DAY Gastritis Erosive Professional Halosten Nausea Other (Haloperidol) C Oral Intake Reduced Vegetamin B C Persecutory Delusion Doral (Quazepam) C Vomiting Magnesium Oxide C Seroquel (Quetiapine Fumarate) C Date:06/03/04ISR Number: 4373996-4Report Type:Expedited (15-DaCompany Report #JP_040503181 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glycosylated Haemoglobin Foreign Zyprexa-Oral Increased Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS 10 MG DAY Company Hirnamin Representative (Levomepromazine) C Other Vegetamin A C Brotizolam C Date:06/03/04ISR Number: 4373998-8Report Type:Expedited (15-DaCompany Report #JP_040503161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Steatosis Foreign Zyprexa-Oral Initial or Prolonged Hepatomegaly Health (Olanzapine) Other Hyperphagia Professional (Olanzapine) PS 10 MG DAY Hypertriglyceridaemia Company Risperdal Increased Appetite Representative (Risperidone) C Weight Increased Other Silece (Flunitrazepam) C Date:06/03/04ISR Number: 4374004-1Report Type:Expedited (15-DaCompany Report #JP_040402955 Age:55 YR Gender:Female I/FU:I Outcome PT Hospitalization - Convulsion Initial or Prolonged Delirium Depressed Level Of Consciousness Extrapyramidal Disorder Hyponatraemia Muscle Rigidity Polydipsia 24-Jun-2005 12:19 PM Page: 2951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhabdomyolysis Tremor Water Intoxication Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 AT Company BEDTIME Representative Rohypnol Other (Flunitrazepam) C Artane (Trihexyphenidyl Hydrochloride) C Sennoside A+B C Date:06/03/04ISR Number: 4374007-7Report Type:Expedited (15-DaCompany Report #GBS040514966 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Olanzapine-Oral Other Epilepsy Health (Olanzapine) PS Professional Other Date:06/03/04ISR Number: 4374008-9Report Type:Expedited (15-DaCompany Report #GBS040514951 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Sensation Foreign Olanzapine-Oral Dyspnoea Health (Olanzapine) PS 20 MG Nausea Professional Lamotrigine C Company Citalopram C Representative Lansoprazole C Other Date:06/03/04ISR Number: 4374054-5Report Type:Expedited (15-DaCompany Report #EWC040438828 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Zyprexa-Oral Initial or Prolonged Coma Health (Olanzapine) Disability Extrapyramidal Disorder Professional (Olanzapine) PS 15 MG/1 DAY Heart Rate Decreased Other Methadone C Intentional Misuse Parkinson'S Disease Suicide Attempt Date:06/03/04ISR Number: 4374063-6Report Type:Expedited (15-DaCompany Report #FR_030402262 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Zyprexa-Oral Hospitalization - Intentional Misuse Health (Olanzapine) Initial or Prolonged Medication Error Professional (Olanzapine) PS 17.5 MG/DAY Pneumonia Aspiration Company Stilnox (Zolpidem) C Sleep Disorder Representative Clopixol - Slow Other Release (Zuclopenthixol 24-Jun-2005 12:19 PM Page: 2952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decanoate) C Tiapridal (Tiapride) C Date:06/03/04ISR Number: 4374073-9Report Type:Expedited (15-DaCompany Report #GBS040414761 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Company Zoton (Lanzoprazole) C Representative Iron Sulfate C Other Aricept (Donepezil Hydrochloride) C Alprazolam C Date:06/03/04ISR Number: 4374665-7Report Type:Expedited (15-DaCompany Report #JP_040403035 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Zyprexa-Oral Initial or Prolonged Autoimmune Health (Olanzapine) Cold Agglutinins Professional (Olanzapine) PS 15 MG DAY Dizziness Postural Company Silece Hypoaesthesia Representative (Flunitrazepam) C Jaundice Other Contomin Laboratory Test Abnormal (Chlorpromazine Pallor Hydrochloride) C Platelet Count Increased Biperiden C Pneumonia Pyrexia Date:06/03/04ISR Number: 4374670-0Report Type:Expedited (15-DaCompany Report #JP_040202632 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiopulmonary Failure Foreign Zyprexa-Oral Condition Aggravated Study (Olanzapine) Constipation Health (Olanzapine) PS 5 MG/DAY Haemorrhage Professional Neuleptil Hyperglycaemia Other (Periciazine) C Papillary Thyroid Cancer Risperdal (Risperidone) C Akineton (Biperiden Hydrochloride) C Pyrethia (Promethazine Hydrochloride) C Sennoside A C Chinese Medicine C Cetilo C Date:06/03/04ISR Number: 4375164-9Report Type:Expedited (15-DaCompany Report #FR_040504152 Age:46 YR Gender:Female I/FU:I Outcome PT Other Fall Hyperglycaemia 24-Jun-2005 12:19 PM Page: 2953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Company Representative Other Date:06/03/04ISR Number: 4375165-0Report Type:Expedited (15-DaCompany Report #CA_040506961 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Zyprexa Medication Error Health Zydis-Dispersible Pharmaceutical Product Professional (Olanzapine) Complaint Other (Olanzapine) PS 2.5 MG/1 Date:06/03/04ISR Number: 4375166-2Report Type:Expedited (15-DaCompany Report #DE_040513573 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Death Foreign Zyprexa -Oral Hospitalization - Brain Oedema Health (Olanzapine) Initial or Prolonged Chronic Obstructive Professional (Olanzapine) PS 15 MG DAY Pulmonary Disease Other Haloperidol C Convulsion Diazepam C Disease Recurrence Ludiomil Drug Level Below (Maprotiline Therapeutic Hydrochloride) C Inappropriate Antidiuretic Hormone Secretion Polydipsia Psychotic Disorder Pupil Fixed Treatment Noncompliance Date:06/03/04ISR Number: 4375167-4Report Type:Expedited (15-DaCompany Report #DE_040513603 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Foreign Zyprexa-Oral Initial or Prolonged Drug Interaction Health (Olanzapine) Drug Level Increased Professional (Olanzapine) PS 15 MG DAY Fall Company Anaesthetic C Femoral Neck Fracture Representative Lamotrigine C Sedation Other Timonil (Carbamazepine) C Lasix (Furosemide) C Ximovan (Zopiclone) C Ebixa (Memantine Hydrochloriede) C Tramal (Tramadol Hydrochloride) C Calcium C Vitamin D C 24-Jun-2005 12:19 PM Page: 2954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4375168-6Report Type:Expedited (15-DaCompany Report #EWC040539270 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Olanzapine-Oral Hospitalization - Increased Health (Olanzapine) PS 300 MG DAY Initial or Prolonged Aspartate Professional Valproic Acid C Aminotransferase Company Increased Representative Blood Alkaline Other Phosphatase Increased Coma Gamma-Glutamyltransferase Increased Overdose Pneumonia Aspiration Rhabdomyolysis Suicide Attempt White Blood Cell Count Increased Date:06/03/04ISR Number: 4375277-1Report Type:Expedited (15-DaCompany Report #FR_040504146 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Angioneurotic Oedema Health (Olanzapine) Bicytopenia Professional (Olanzapine) PS 10 MG DAY Thrombocytopenia Company Representative Other Date:06/04/04ISR Number: 4371805-0Report Type:Direct Company Report #CTU 220124 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa 10 Mg Lilly PS Lilly INTRAMUSCULAR IM Date:06/07/04ISR Number: 4373761-8Report Type:Direct Company Report #CTU 220230 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Keppra 500 Mg PS ORAL 500 MG BID Initial or Prolonged ORAL Required Zyprexa 20 Mg SS ORAL 20 MG QD ORAL Intervention to Prevent Permanent Impairment/Damage Date:06/07/04ISR Number: 4373772-2Report Type:Direct Company Report #CTU 220204 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polydipsia Zyprexa 5mg 3 Q H Polyuria S PS ORAL PO 5 MG QHS Weight Increased 24-Jun-2005 12:19 PM Page: 2955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/04ISR Number: 4375912-8Report Type:Expedited (15-DaCompany Report #EWC040539371 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Foreign Zyprexa-Oral Dysuria Consumer (Olanzapine) Feeling Cold Other (Olanzapine) PS 5 MG/1 DAY Skin Discolouration Swelling Date:06/07/04ISR Number: 4375920-7Report Type:Expedited (15-DaCompany Report #EWC040539355 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im(Olanzapine) PS 30 MG DAY Professional Tavor (Lorazepam) C Company Largactil Representative (Chlorpromazine Other Hydrochloride) C Talofen (Promazine Hydrochloride) C Farganesse (Promethazine Hydrochloride) C Date:06/08/04ISR Number: 4374268-4Report Type:Direct Company Report #CTU 220336 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Zyprexa 15 Mg PS ORAL 15 MG QHS PO 2 YR Required Increased Gemfibrozil 600 Mg Intervention to Liver Function Test Bid SS 600 MG BID Prevent Permanent Abnormal Zoloft C Impairment/Damage Klonopin C Metoprolol C Hydrochlorothiazide C Date:06/09/04ISR Number: 4377370-6Report Type:Expedited (15-DaCompany Report #DE_040313111 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Hepatic Function Abnormal Health (Olanzapine) Psychotic Disorder Professional (Olanzapine) PS 20 MG DAY Company Risperidone C Representative Other Date:06/09/04ISR Number: 4377432-3Report Type:Expedited (15-DaCompany Report #JP_040503172 Age:26 YR Gender:Male I/FU:I Outcome PT Death Alanine Aminotransferase Other Increased Anuria Aspartate Aminotransferase 24-Jun-2005 12:19 PM Page: 2956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Chloride Decreased Blood Cholesterol Increased Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Foreign Zyprexa-Oral Blood Pressure Decreased Health (Olanzapine) Blood Sodium Decreased Professional (Olanzapine) PS 20 MG AT Blood Triglycerides Company BEDTIME Increased Representative Levotomin Cardiac Arrest Other (Levomepromazine Coma Maleate) C Depressed Level Of Rohipnol Consciousness (Flunitrazepam) C Diabetic Ketoacidosis Heart Rate Increased Hyperglycaemia Hyperphagia Hyperventilation Hypoalbuminaemia Malaise Metabolic Acidosis Nausea Po2 Decreased Polydipsia Polyuria Pyrexia Restlessness Thirst Vomiting Water Intoxication Weight Increased Date:06/09/04ISR Number: 4377451-7Report Type:Expedited (15-DaCompany Report #DE_040513648 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Creatine Phosphokinase Foreign Zyprexa-Oral Initial or Prolonged Decreased Health (Olanzapine) Other Fall Professional (Olanzapine) PS 30 MG/1 DAY Hallucination Company Glianimon Infection Representative (Benperidol) C Neuroleptic Malignant Other Pantozol Syndrome (Pantoprazole Overdose Sodium) C Polytraumatism Nac (Acetylcysteine) C Psychotic Disorder Retrograde Amnesia Date:06/09/04ISR Number: 4377452-9Report Type:Expedited (15-DaCompany Report #DE_040513667 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Convulsion Health (Olanzapine) Psychotic Disorder Professional (Olanzapine) PS 15 MG DAY Company Pantozol Representative (Pantoprazole Other Sodium) C Diazepam C Taxilan (Perazine) C 24-Jun-2005 12:19 PM Page: 2957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/04ISR Number: 4377453-0Report Type:Expedited (15-DaCompany Report #EWC040539372 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Olanzapine-Oral Hospitalization - Injury Asphyxiation Health (Olanzapine) PS 20 MG DAY Initial or Prolonged Schizophrenia Professional Olanzapine-Rapid-Act Other ing Im SS 30 MG IN THE MORNING Reladorm C Cyclodol (Cyclodol) C Date:06/09/04ISR Number: 4377481-5Report Type:Expedited (15-DaCompany Report #JP_040503230 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG DAY Company Cercine (Diazepam) C Representative Seroquel (Quetiapine Other Fumarate) C Vegetamin B C Nurovitan C Date:06/09/04ISR Number: 4377482-7Report Type:Expedited (15-DaCompany Report #GBS040514995 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Olanzapine-Oral Hospitalization - Circulatory Collapse Health (Olanzapine) PS Initial or Prolonged Hyperglycaemia Professional Hypothermia Other Overdose Date:06/09/04ISR Number: 4377483-9Report Type:Expedited (15-DaCompany Report #EWC040539398 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Injury Foreign Zyprexa-Oral Initial or Prolonged Femoral Neck Fracture Health (Olanzapine) Intentional Self-Injury Professional (Olanzapine) PS 20 MG/ 1 DAY Lung Injury Other Rivotril Skeletal Injury (Clonazepam) C Date:06/09/04ISR Number: 4377484-0Report Type:Expedited (15-DaCompany Report #EWC040539402 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Olanzapine-Dispersib Hospitalization - Cardio-Respiratory Arrest Consumer le (Olanzapine) PS Initial or Prolonged Grand Mal Convulsion Health Olanzapine-Oral Haemorrhagic Stroke Professional (Olanzapine) SS 2.5 MG Tremor Other 24-Jun-2005 12:19 PM Page: 2958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/04ISR Number: 4377485-2Report Type:Expedited (15-DaCompany Report #EWC040539408 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Rigidity Foreign Olanzapine-Oral Alanine Aminotransferase Health (Olanzapine) PS 7.5 MG DAY Increased Professional Gutron (Midodrine Aspartate Other Hydrochloride) C Aminotransferase Leponex (Clozapine) C Increased Remeron Biliary Colic (Mirtazapine) C Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased Urinary Tract Infection Vomiting Date:06/09/04ISR Number: 4377487-6Report Type:Expedited (15-DaCompany Report #EWC040539409 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Olanzapine-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) PS 20 MG/1 DAY Other Delusional Disorder, Professional Macrogol C Unspecified Type Other Multivitamin C Malnutrition Calcium Carbonate C Tardive Dyskinesia Estrogen W/Medroxyprogesteron e C Potassium Chloride C Lorazepam C Zolpidem Tartrate C Naproxen C Quetiapine Fumarate C Diazepam C Lactulose C Sodium Citrate C Date:06/09/04ISR Number: 4377489-XReport Type:Expedited (15-DaCompany Report #EWC040539424 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 2.5 MG DAY Aspartate Professional Aminotransferase Company Increased Representative Condition Aggravated Other Psychotic Disorder Date:06/09/04ISR Number: 4378058-8Report Type:Expedited (15-DaCompany Report #JP_040503181 Age: Gender:Male I/FU:F Outcome PT Other Glycosylated Haemoglobin Increased 24-Jun-2005 12:19 PM Page: 2959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperglycaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Hirnamin Representative (Levomepromazine) C Other Vegetamin A C Brotizolam C Date:06/09/04ISR Number: 4378059-XReport Type:Expedited (15-DaCompany Report #JP_040503182 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Zyprexa-Oral Initial or Prolonged Femoral Neck Fracture Health (Olanzapine) Gastritis Erosive Professional (Olanzapine) PS 5 MG DAY Nausea Other Halosten Oral Intake Reduced (Haloperidol) C Persecutory Delusion Vegetamin B C Vomiting Doral (Quazepam) C Magnesium Oxide C Seroquel (Quetiapine Fumarate) C Date:06/09/04ISR Number: 4378060-6Report Type:Expedited (15-DaCompany Report #GBS040514966 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Olanzapine-Oral Other Health (Olanzapine) PS UNKNOWN UNK Professional Other Date:06/09/04ISR Number: 4378061-8Report Type:Expedited (15-DaCompany Report #JP_040403035 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Zyprexa-Oral Initial or Prolonged Autoimmune Health (Olanzapine) Cold Agglutinins Positive Professional (Olanzapine) PS 15 MG DAY Dizziness Postural Company Silece Hypoaesthesia Representative (Flunitrazepam) C Jaundice Other Contomin Pallor (Chlorpromazine Platelet Count Increased Hydrochloride) C Pneumonia Biperiden C Pyrexia Date:06/09/04ISR Number: 4378131-4Report Type:Expedited (15-DaCompany Report #JP_040503186 Age:55 YR Gender:Female I/FU:I Outcome PT Other Electrocardiogram Abnormal Electrocardiogram Qt 24-Jun-2005 12:19 PM Page: 2960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Company Representative Other Date:06/09/04ISR Number: 4378140-5Report Type:Expedited (15-DaCompany Report #JP_040503216 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menorrhagia Foreign Zyprexa Health (Olanzapine) PS ORAL 2.5 MG DAY Professional Other Date:06/09/04ISR Number: 4378149-1Report Type:Expedited (15-DaCompany Report #USA040259216 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Prozac-Oral Hospitalization - Increased Appetite Professional (Fluoxetine) Initial or Prolonged Weight Increased Company (Fluoxetine Representative Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Seroquel (Quetiapine Fumarate) C Topamax (Topiramate) C Protonix (Pantoprazole) C Depo Provera (Medroxyprogesterone Acetate) C Klonopin (Clonazepam) C Date:06/09/04ISR Number: 4378181-8Report Type:Expedited (15-DaCompany Report #USA040568461 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Health Symbyax Olanzapine 6 Initial or Prolonged Hiatus Hernia Professional Mg / Fluoxetine 25 Impaired Gastric Emptying Company Mg (Olanzapine PS Intestinal Dilatation Representative Zyprexa-Oral Irritable Bowel Syndrome (Olanzapine) SS 2.5 MG /2 DAY Sinusitis Prozac -Oral Syncope (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG/1 DAY Xanax (Alprazolam) C Depakote (Valporate Semisodium) C 24-Jun-2005 12:19 PM Page: 2961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/04ISR Number: 4378197-1Report Type:Expedited (15-DaCompany Report #EWC991104979 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiogenic Shock Foreign Zyprexa-Oral Initial or Prolonged Drug Interaction Literature (Olanzapine) Hypothermia Health (Olanzapine) PS 5 MG/1 DAY Loss Of Consciousness Professional Aricept (Donepezil Miosis Company Hydrochloride) C Sinus Bradycardia Representative Potassium Chloride C Other Ativan (Lorazepam) C Seroxat (Paroxetine Hydrochloride) C Imovane (Zopiclone) C Aspirin C Date:06/09/04ISR Number: 4378242-3Report Type:Expedited (15-DaCompany Report #EWC040539270 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Olanzapine Hospitalization - Hyperpyrexia Health (Olanzapine) PS ORAL 300 MG DAY Initial or Prolonged Intentional Misuse Professional Valproic Acid C ORAL Pneumonia Aspiration Company Rhabdomyolysis Representative Suicide Attempt Other Date:06/09/04ISR Number: 4378253-8Report Type:Expedited (15-DaCompany Report #FR_040403838 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa Other Head Injury Health (Olanzapine) PS ORAL 20 MG 1 DAY Lung Disorder Professional Zyprexa Mendelson'S Syndrome Company Rapid Acting Im Pulmonary Oedema Representative (Olanzapine) SS INTRAMUSCULAR 10 MG/1 OTHER Suicide Attempt Other Leponex (Clozapine) C Date:06/09/04ISR Number: 4378257-5Report Type:Expedited (15-DaCompany Report #DE_040413455 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Foreign Zyprexa Initial or Prolonged Health (Olanzapine) PS 10 MG / 2 DAY Professional Company Representative Other Date:06/09/04ISR Number: 4378266-6Report Type:Expedited (15-DaCompany Report #EWC040539350 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Death Pulmonary Oedema Foreign Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 2962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa - Rapid - Acting Im (Olanzapine) PS INTRAMUSCULAR 10 MG Tavor (Lorazepam) C Talofen(Promazine Hydrochloride) C Seroquel (Quetiapine Fumarate) C Date:06/09/04ISR Number: 4378286-1Report Type:Expedited (15-DaCompany Report #USA040566907 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haematoma Health Zyprexa-Rapid-Acting Coma Professional Im (Olanzapine) PS 5 MG Fall Company Lorazepam C Haemorrhagic Stroke Representative Haldol (Haloperidol) C Head Injury Laceration Date:06/09/04ISR Number: 4378288-5Report Type:Expedited (15-DaCompany Report #USA040361576 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) Other Spinal Fracture Company (Olanzapine) PS 10 MG/1 DAY 1 WK Representative Neurontin (Gabapentin) C Paxil (Paroxetine Hydrochloride) C Date:06/09/04ISR Number: 4378507-5Report Type:Expedited (15-DaCompany Report #US_030494123 Age:40 YR Gender:Male I/FU:F Outcome PT Death Acute Respiratory Other Distress Syndrome Blood Chloride Decreased Blood Creatinine Increased Blood Ph Increased Blood Sodium Decreased Blood Urea Increased Body Temperature Increased Cardiac Arrest Cardio-Respiratory Arrest Cerebrovascular Accident Csf White Blood Cell Count Positive Diabetes Mellitus Diabetic Hyperosmolar Coma Diabetic Ketoacidosis 24-Jun-2005 12:19 PM Page: 2963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Disseminated Intravascular Coagulation Report Source Product Role Manufacturer Route Dose Duration Dysarthria Consumer Zyprexa-Oral Dyspnoea (Olanzapine) Electroencephalogram (Olanzapine) PS Abnormal Prozac-Oral Epistaxis (Fluoxetine) Fall (Fluoxetine Fatigue Hydrochloride) SS 20 MG/2 DAY Feeling Abnormal Depakote (Valproate Fibrin Degradation Semisodium) C Products Prilosec Head Injury (Omeprazole) C Hyperthermia Trazodone C Hypotension Clonidine C Lymphocyte Count Neurontin Decreased (Gabapentin) C Multi-Organ Failure Verapamil C Neutrophil Count Buspar (Buspirone Increased Hydrochloride) C Pco2 Decreased Risperdal Pneumonia (Risperidone) C Red Blood Cell Count Decreased Renal Failure Sepsis Swan Ganz Catheter Placement Ventricular Tachycardia Date:06/09/04ISR Number: 4378646-9Report Type:Expedited (15-DaCompany Report #FRWYE740804MAY04 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Temesta (Lorazepam, Catatonia Professional Tablet) PS ORAL 2.5 MG 1X PER Other 1 DAY, ORAL; SEVERAL YEARS Motilium (Domperidone, , 0) SS ORAL 30 MG 1X PER 1 DAY, ORAL Parkinane (Trihexyphenidyl, Tablet, 0) SS ORAL 5 MG 1X PER 1 DAY, ORAL; SEVERAL YEARS Rythmol (Propafenone Hydrochloride, , 0) SS ORAL 300 MG 1X PER 1 DAY, ORAL Zyprexa (Olanzapine, , 0) SS ORAL 10 MG 1X PER 1 DAY, ORAL 61 DAY 24-Jun-2005 12:19 PM Page: 2964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/04ISR Number: 4378766-9Report Type:Expedited (15-DaCompany Report #US_0406103381 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Consumer Zyprexa-Oral(Olanzap Dysarthria ine) (Olanzapine) PS Hypoventilation Imprisonment Incoherent Ketoacidosis Lethargy Loss Of Consciousness Pulmonary Oedema Refusal Of Treatment By Patient Date:06/09/04ISR Number: 4378767-0Report Type:Expedited (15-DaCompany Report #US_0405103203 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Other Zyprexa-Oral Murder (Olanzapine) (Olanzapine) PS Paxil (Paroxetine Hydrochloride) C Date:06/09/04ISR Number: 4378768-2Report Type:Expedited (15-DaCompany Report #USA040568574 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 15 MG DAY Date:06/09/04ISR Number: 4378769-4Report Type:Expedited (15-DaCompany Report #USA040568394 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Non-Insulin-Dependent (Olanzapine) PS 5 MG/1 AT BEDTIME Trileptal (Oxacarbazepine) C Keppra (Levetiracetam) C Date:06/09/04ISR Number: 4378770-0Report Type:Expedited (15-DaCompany Report #USA040568452 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa-Oral Initial or Prolonged Weight Increased (Olanzapine) PS 25 MG Other 24-Jun-2005 12:19 PM Page: 2965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/04ISR Number: 4379062-6Report Type:Expedited (15-DaCompany Report #200411828GDS Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Periplum Initial or Prolonged Health (Nimodipine) PS ORAL BID, ORAL Professional Zyprexa (Olanzapine) SS ORAL 5 MG, TOTAL Other DAILY, ORAL Tiklid (Ticlopidine Hydrochloride) SS ORAL 250 MG, QD, ORAL Date:06/14/04ISR Number: 4377244-0Report Type:Direct Company Report #CTU 220647 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Zyprexa 5mg PS ORAL 5MG DAILY Initial or Prolonged Pregnancy ORAL Required Neonatal Disorder Intervention to Sedation Prevent Permanent Impairment/Damage Date:06/14/04ISR Number: 4380992-XReport Type:Expedited (15-DaCompany Report #GBWYE812008JUN04 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Musculoskeletal Stiffness Health Efexor (Venlafaxine Hospitalization - Nuchal Rigidity Professional Hydrochloride, Initial or Prolonged Opisthotonus Other Tablet, 0) PS ORAL 75 MG 10 DAY Other Respiratory Arrest Olanzapine (Olanzapine, , 0) SS ORAL 5 MG 66 DAY Propranolol (Propranolol) C Cinnarizine (Cinnarizine) C Date:06/14/04ISR Number: 4381004-4Report Type:Expedited (15-DaCompany Report #GBWYE812008JUN04 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Musculoskeletal Stiffness Health Efexor (Venlafaxine Hospitalization - Nuchal Rigidity Professional Hydrochloride, Initial or Prolonged Opisthotonus Other Tablet, 0) PS ORAL 75 MG 10 DAY Other Respiratory Arrest Olanzapine (Olanzapine, , 0) SS ORAL 5 MG 66 DAY Propranolol (Propranolol) C Cinnarizine (Cinnarizine) C Date:06/16/04ISR Number: 4380751-8Report Type:Expedited (15-DaCompany Report #CA_040506961 Age:74 YR Gender:Male I/FU:F Outcome PT Other Blood Pressure Systolic Increased Cerebral Atrophy 24-Jun-2005 12:19 PM Page: 2966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reversible Ischaemic Neurological Deficit Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa Health Zydis-Dispersible Professional (Olanzapine) Other (Olanzapine) PS 2.5 MG/1 Acetylsalicylic Acid C Plavix (Clopidogrel Sulfate) C Enoxaparin C Lasix (Furosemide) C Atorvastatin C Desipramine C Metformin C Metoprolol C Date:06/16/04ISR Number: 4380778-6Report Type:Expedited (15-DaCompany Report #JP_040302805 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Foreign Zyprexa-Oral Initial or Prolonged Blood Lactate Study (Olanzapine) Dehydrogenase Increased Health (Olanzapine) PS 10 MG/1 DAY Blood Triglycerides Professional Tasmolin (Biperiden) C Increased Other Levotomin Depressed Level Of (Levomepromazine Consciousness Maleate) C Eating Disorder Lexotan (Bromazepam) C Hypokalaemia Aspara K (Aspartate Potassium) C Alinamin F (Fursultiamine) C Date:06/16/04ISR Number: 4380779-8Report Type:Expedited (15-DaCompany Report #JP_040302878 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Depressive Symptom Foreign Zyprexa-Oral Idiopathic Health (Olanzapine) Thrombocytopenic Purpura Professional (Olanzapine) PS 2.5 MG DAY Refusal Of Treatment By Company Toledomin Patient Representative (Milnacipran Hydrochloride) C Depas (Etizolam) C Date:06/16/04ISR Number: 4380781-6Report Type:Expedited (15-DaCompany Report #JP_040403038 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusion Foreign Zyprexa-Oral Other Diet Refusal Health (Olanzapine) Hallucination Professional (Olanzapine) PS 30 MG DAY Prescribed Overdose Company Wypax (Lorazepam) C Refusal Of Treatment By Representative Carbamazepine C Patient Other Chlorpromazine C Stupor Levotomin (Levomepromazine 24-Jun-2005 12:19 PM Page: 2967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) C Alosenn C Seroquel (Quetiapine Fumarate) C Date:06/16/04ISR Number: 4380901-3Report Type:Expedited (15-DaCompany Report #EWC040639444 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Complications Of Foreign Olanzapine-Oral Hospitalization - Transplanted Kidney Health (Olanzapine) PS 5 MG DAY Initial or Prolonged Dialysis Professional Cellcept Electroencephalogram Other (Mycophenolate Abnormal Mofetil) C Hallucination, Visual Solu-Medrol Neuroleptic Malignant (Methylprednisolone Syndrome Sodium Succinate) C Renal Necrosis Cortef Ultrasound Kidney (Hydrocortisone Abnormal Acetate) C Atg-Fresenius (Antithymocyte Immunoglobulin) C Lasix (Furosemide) C Date:06/16/04ISR Number: 4380902-5Report Type:Expedited (15-DaCompany Report #DE_040613700 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Foreign Zyprexa-Oral Ecchymosis Health (Olanzapine) Professional (Olanzapine) PS A FEW WEEKS Other Risperdal (Risperidone) C Date:06/16/04ISR Number: 4380903-7Report Type:Expedited (15-DaCompany Report #EWC040639489 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 2.5 MG/2 DAY Professional Tiklid(Ticlopidine Other Hydrochloride) C Periplum (Nimodipine) C Date:06/16/04ISR Number: 4380904-9Report Type:Expedited (15-DaCompany Report #GBS040615033 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Congestive Cardiomyopathy Foreign Olanzapine-Oral Hospitalization - Health (Olanzapine) PS 10 MG Initial or Prolonged Professional Clomipramine C Other Bendrofluazide C Aspirin C 24-Jun-2005 12:19 PM Page: 2968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/04ISR Number: 4380905-0Report Type:Expedited (15-DaCompany Report #JP_040503225 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Intentional Misuse Study (Olanzapine) Health (Olanzapine) PS 5 MG/2 DAY Professional Lexotan (Bromazepam) C Other Hiberna (Promethazine Hydrochloride) C Vegetamin B C Eurodin (Estazolam) C Rohipnol (Flunitrazepam) C Alosenn C Tinelac (Sennoside A+B) C Date:06/16/04ISR Number: 4381225-0Report Type:Expedited (15-DaCompany Report #US_0403101897 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Zyprexa-Oral Hospitalization - Anger Health (Olanzapine) Initial or Prolonged Anxiety Professional (Olanzapine) PS 30 MG DAY Completed Suicide Mellaril Convulsion (Thioridazine Drug Level Increased Hydrochloride) C Drug Withdrawal Syndrome Advair C Hallucination, Auditory Clonazepam C Homicidal Ideation Phenytoin C Illusion Ambien (Zolpidem Personality Change Tartrate) C Prescribed Overdose Protonix Suicidal Ideation (Pantoprazole) C Combivent C Methocarbamol C Hydrocodone W/Apap C Famotidine C Zanaflex (Tizanidine Hydrochloride) C Diazepam C Belladonna Alkaloids C Carisoprodol C Promethazine C Atropine W/Diphenoxylate C Sulfamethoxazole W/Trimethoprim C Skelaxin (Metaxalone) C Amoxicillin C Propoxyphene C Tetracycline C Tylenol W/Codeine No. 3 C Metoclopramide C Neurontin (Gabapentin) C Temazepam C 24-Jun-2005 12:19 PM Page: 2969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zithromax (Azithromycin) C Albuterol C Tequin (Gatifloxacin) C Wellbutrin Sr (Bupropion Hydrochloride) C Chlorpromazine C Nicotrol (Nicotine) C Ultram (Tramadol Hydrochloride) C Lorazepam C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Trazadone (Trazodone) C Seroquel (Quetiapine Fumarate) C Ketorolac C Depakote (Valproate Semisodium) C Diflucan (Fluconazole) C Premphase C Hyoscyamine C Dicyclomine (Dicycloverine) C Tizanidine C Vioxx (Rofecoxib) C Klonopin (Clonazepam) C Metamucil (Psyllium Hydrophilic Mucilloid) C Date:06/16/04ISR Number: 4381227-4Report Type:Expedited (15-DaCompany Report #USA040568383 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Health Zyprexa-Oral Menstruation Irregular Professional (Olanzapine) Uterine Haemorrhage Company (Olanzapine) PS 10 MG/1 DAY Representative Date:06/16/04ISR Number: 4381238-9Report Type:Expedited (15-DaCompany Report #USA040568683 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Consumer Zyprexa-Oral Initial or Prolonged Living Impaired (Olanzapine) Disability Amnesia (Olanzapine) PS 7.5 MG DAY Dysgraphia Road Traffic Accident 24-Jun-2005 12:19 PM Page: 2970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/04ISR Number: 4381240-7Report Type:Expedited (15-DaCompany Report #USA040568810 Age:70 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:06/16/04ISR Number: 4381252-3Report Type:Expedited (15-DaCompany Report #USA040668979 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Health Zyprexa-Oral Jaundice Professional (Olanzapine) Weight Increased (Olanzapine) PS 20 MG DAY Abilify(Aripiprazole ) C Lithium C Cogentin(Benzatropin e Mesilate) C Date:06/16/04ISR Number: 4381258-4Report Type:Expedited (15-DaCompany Report #USA040669123 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inappropriate Health Zyprexa-Oral Initial or Prolonged Antidiuretic Hormone Professional (Olanzapine) Secretion (Olanzapine) PS 4 MON Date:06/16/04ISR Number: 4381329-2Report Type:Expedited (15-DaCompany Report #US_0406103435 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Literature Olanzapine-Oral Health (Olanzapine) PS Professional Dextroamphetamine C Trazodone C Date:06/16/04ISR Number: 4381332-2Report Type:Expedited (15-DaCompany Report #US_0406103429 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Ethanol C Date:06/16/04ISR Number: 4381336-XReport Type:Expedited (15-DaCompany Report #US_0406103427 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Literature Olanzapine-Oral Health (Olanzapine) PS Professional Charcoal, Activated C 24-Jun-2005 12:19 PM Page: 2971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/04ISR Number: 4381338-3Report Type:Expedited (15-DaCompany Report #US_0406103434 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Professional Venlafaxine C Date:06/16/04ISR Number: 4381339-5Report Type:Expedited (15-DaCompany Report #US_0406103421 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine-Oral Drug Toxicity Health (Olanzapine) PS Multiple Drug Overdose Professional Caffeine C Valproic Acid C Date:06/16/04ISR Number: 4381393-0Report Type:Expedited (15-DaCompany Report #US_0406103422 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Alprazolam C Bupropion C Date:06/16/04ISR Number: 4381395-4Report Type:Expedited (15-DaCompany Report #US_0406103409 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine -Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Bupropion C Carbamazepine C Date:06/16/04ISR Number: 4381401-7Report Type:Expedited (15-DaCompany Report #US_0406103410 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine Oral Intentional Misuse Health (Olanzapine) PS Professional Bupropion C Clonazepam C Date:06/16/04ISR Number: 4381403-0Report Type:Expedited (15-DaCompany Report #US_0406103397 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine Oral Intentional Misuse Health (Olanzapine) PS Professional Acetaminophen C Paroxetine C 24-Jun-2005 12:19 PM Page: 2972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/04ISR Number: 4381410-8Report Type:Expedited (15-DaCompany Report #US_0406103403 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine Oral Intentional Misuse Health (Olanzapine) PS Professional Aspirin C Valproic Acid C Date:06/16/04ISR Number: 4381413-3Report Type:Expedited (15-DaCompany Report #US_0406103406 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine - Oral Intentional Misuse Health (Olanzapine) PS Professional Valproic Acid C Gabapentin C Date:06/16/04ISR Number: 4381415-7Report Type:Expedited (15-DaCompany Report #US_0406103433 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Olanzapine Oral Completed Suicide Health (Olanzapine) PS Intentional Misuse Professional Morphine C Date:06/16/04ISR Number: 4381416-9Report Type:Expedited (15-DaCompany Report #USA040669067 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Symbyax-Olanzapine / Drug Level Increased Fluoxetine (Unknown Medication Error Dose) (Ola PS Seroquel (Quetiapine Fumarate) C Trazadone (Trazodone) C Date:06/17/04ISR Number: 4381183-9Report Type:Direct Company Report #CTU 221016 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oedema Peripheral Olanzapine PS ORAL 7.5 MG PO QD Intervention to Folic Acid C Prevent Permanent Levothyroid C Impairment/Damage Multivitamin C Prilosec C Tacation C Date:06/18/04ISR Number: 4383110-7Report Type:Expedited (15-DaCompany Report #US_0406103419 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Exposure To Toxic Agent Literature Olanzapine-Oral Health (Olanzapine) PS Professional Paroxetine C Trazodone C 24-Jun-2005 12:19 PM Page: 2973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/04ISR Number: 4383113-2Report Type:Expedited (15-DaCompany Report #US_0406103424 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Olanzapine-Oral Exposure To Toxic Agent Health (Olanzapine) PS Professional Diazepam C Amiloride C Date:06/18/04ISR Number: 4383129-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102715 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Study Risperidone Weight Increased Health (Risperidone) Professional Unspecified PS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Ziprasidone (Ziprasidone) SS Perphenazine (Perphenazine) SS Date:06/18/04ISR Number: 4383304-0Report Type:Expedited (15-DaCompany Report #US_0406103430 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Exposure To Toxic Agent Literature Olanzapine-Oral Multiple Drug Overdose Health (Olanzapine) PS Professional Lithium C Date:06/18/04ISR Number: 4383306-4Report Type:Expedited (15-DaCompany Report #US_0406103432 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Olanzapine-Oral Therapeutic Agent Health (Olanzapine) PS Toxicity Professional Mirtazapine C Lisinopril C Date:06/21/04ISR Number: 4382392-5Report Type:Direct Company Report #CTU 221132 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Zyprexa 10 Mg Intervention to Increased Tablets Lilly PS Lilly ORAL 10 MG-20 MG Prevent Permanent Aspartate DAILY ORAL Impairment/Damage Aminotransferase Haloperidol C Increased Lorazepam C 24-Jun-2005 12:19 PM Page: 2974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/04ISR Number: 4391151-9Report Type:Periodic Company Report #USA-2003-0011606 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Naproxen (Naproxen) SS Trazodone (Trazodone) SS Diclofenac Sodium (Diclofenac Sodium) SS Propoxyphene (Dextropropoxyphene) SS Cogentin (Benzatropine Mesilate) SS Vistaril (Hydroxyzine Embonate) SS Zyprexa (Olanzapine) SS Sertraline (Sertraline) SS Quetiapine (Quetiapine) SS Temazepam (Temazepam) SS Acetaminophen (Paracetamol) SS Caffeine (Caffeine) SS Nicotine (Nicotine) SS Valproic Acid (Valproic Acid) SS Date:06/21/04ISR Number: 4396028-0Report Type:Periodic Company Report #USA-2003-0010834 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Consumer Oxycodone Overdose Health Hydrochloride Professional (Similar To Nda Other 20-553) (Oxycodone Hydrochloride) PS Hydrocodone Bitartrate (Similar To Ind 59,175) (Hydrocodone Bitartrate) SS Gemfibrozil (Gemfibrozil) SS Sertraline (Sertraline) SS Alprazolam (Alprazolam) SS Chlordiazepoxide (Chlordiazepoxide) SS Olanzapine (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 2975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/04ISR Number: 4396040-1Report Type:Periodic Company Report #USA-2003-0010837 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Tablets Multiple Drug Overdose Professional (Oxycodone Other Hydrochloride) PS Diltiazem (Diltiazem) SS Flurazepam (Flurazepam) SS Chlordiazepoxide (Chlordiazepoxide) SS Alprazolam (Alprazolam) SS Fluoxetine (Fluoxetine) SS Olanzapine (Olanzapine) SS Mirtazapine (Mirtazapine) SS Date:06/21/04ISR Number: 4398869-2Report Type:Periodic Company Report #USA-2003-0007319 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Tablets Drug Abuser Professional (Oxycodone Other Hydrochloride) PS 40 MG Cocaine (Cocaine) SS Fluoxetine (Fluoxetine) SS Olanzapine (Olanzapine) SS Salmeterol (Salmeterol) SS Date:06/21/04ISR Number: 4415457-XReport Type:Periodic Company Report #USA-2003-0012093 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Other Oxycodone Hydrochloride (Similar Nda 20-553) (Oxycodone Hydrochloride) PS Morphine Sulfate (Similar To Nda 19516)(Morphine Sulfate) SS Hydrocodone Bitartrate (Similar To Ind 59175)(Hydrocodone Bitartrate) SS Oxazepam (Oxazepam) SS Cocaine (Cocaine) SS Acetaminophen (Paracetamol) SS Propoxyphene 24-Jun-2005 12:19 PM Page: 2976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Dextropropoxyphene) SS Sertraline (Sertraline) SS Olanzapine (Olanzapine) SS Trazodone (Trazodone) SS Lidocaine (Lidocaine) SS Nicotine (Nicotine) SS Caffeine (Caffeine) SS Date:06/21/04ISR Number: 4415609-9Report Type:Periodic Company Report #USA-2003-0011837 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Alprazolam (Alprazolam) SS Cocaine (Cocaine) SS Sertraline (Sertraline) SS Acetaminophen (Paracetamol) SS Cannabis (Cannabis) SS Carisoprodol (Carisoprodol) SS Meprobamate (Meprobamate) SS Olanzapine (Olanzapine) SS Lorazepam (Lorazepam) SS Date:06/22/04ISR Number: 4385125-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040602712 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Neoperidol Rhabdomyolysis Health (Haloperidol Professional Decanoate) Injection PS INTRAMUSCULAR 50 MG, IN 1 DAY, INTRAMUSCULAR Zyprexa (Olanzapine) SS ORAL 20 MG, IN 1 DAY, ORAL Perospirone (All Other Therapeutic Products) SS ORAL 48 MG, 1 IN 1 DAY, ORAL 24-Jun-2005 12:19 PM Page: 2977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/04ISR Number: 4385447-4Report Type:Expedited (15-DaCompany Report #S04-USA-02172-01 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Lexapro Initial or Prolonged Coma Professional (Escitalopram) PS Depressed Level Of Lexapro Consciousness (Escitalopram) SS ORAL 10 MG QD PO Drug Abuser Depakote (Valproate Electrocardiogram St Semisodium) SS Segment Zyprexa (Olanzapine) SS Medication Error Alcohol SS Multiple Drug Overdose Cocaine SS Self-Medication Date:06/23/04ISR Number: 4383607-XReport Type:Expedited (15-DaCompany Report #PHNR2004AU00908 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Flutter Clozaril PS Novartis Sector: Hospitalization - Cardiac Failure Pharma 12.5 - 75 Initial or Prolonged Cellulitis mg/day 40320MIN Death Valproate Sodium SS Decreased Appetite Efexor SS Difficulty In Walking Haloperidol SS Fall Lorazepam SS Flat Affect Olanzapine SS Gait Disturbance Benztropine Mesylate SS Haemoglobin Decreased Hypotension Injury Lobar Pneumonia Lymphopenia Malaise Mycoplasma Infection Myocarditis Oxygen Saturation Decreased Peroneal Nerve Palsy Pyrexia Restlessness Rib Fracture Somnolence Tachycardia Thrombocytopenia Date:06/23/04ISR Number: 4385006-3Report Type:Direct Company Report #CTU 221379 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Increased PO Date:06/23/04ISR Number: 4385663-1Report Type:Expedited (15-DaCompany Report #FR_031003067 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Death Death Foreign Health 24-Jun-2005 12:19 PM Page: 2978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG/1 DAY Symbicort C Imovane (Zopiclone) C Date:06/23/04ISR Number: 4385666-7Report Type:Expedited (15-DaCompany Report #FR_040303674 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Foreign Zyprexa-Oral Initial or Prolonged Distress Syndrome Health (Olanzapine) Diabetic Ketoacidosis Professional (Olanzapine) PS Hypokalaemia Other Hypophosphataemia Hypovolaemia Pancreatitis Proteinuria Renal Failure Renal Tubular Necrosis Date:06/23/04ISR Number: 4385668-0Report Type:Expedited (15-DaCompany Report #FR_040403857 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Failure Foreign Zyprexa-Rapid Initial or Prolonged Blood Calcium Decreased Health -Acting Im Blood Creatinine Professional (Olanzapine) PS 10 MG DAY Decreased Company Zyprexa-Oral Blood Glucose Increased Representative (Olanzapine) Blood Lactate Other (Olanzapine) SS 10 MG DAY Dehydrogenase Increased Deroxat (Paroxetine Blood Sodium Decreased Hydrochloride) C Pyrexia Atarax (Hydroxyzine Refusal Of Treatment By Hydrochloride) C Patient Tranxene Somnolence (Clorazepate Dipotassium) C Stilnox (Zolpidem) C Date:06/23/04ISR Number: 4385669-2Report Type:Expedited (15-DaCompany Report #JP_040503186 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 5 MG DAY Electrocardiogram Qt Company Levotomin Prolonged Representative (Levomepromazine Heart Rate Decreased Other Maleate) C Magnesium Oxide C 24-Jun-2005 12:19 PM Page: 2979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/04ISR Number: 4385678-3Report Type:Expedited (15-DaCompany Report #FR_030302176 Age:1 DY Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Foreign Zyprexa-Oral Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS Drug Withdrawal Syndrome Other Neonatal Dystonia Gastrooesophageal Reflux Disease Growth Retardation Neonatal Disorder Psychomotor Retardation Tremor Date:06/23/04ISR Number: 4385716-8Report Type:Expedited (15-DaCompany Report #JP_040403035 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Zyprexa-Oral Initial or Prolonged Autoimmune Health (Olanzapine) Cold Agglutinins Positive Professional (Olanzapine) PS 15 MG DAY Hypoaesthesia Company Silece Platelet Count Increased Representative (Flunitrazepam) C Pneumonia Other Contomin (Chlorpromazine Hydrochloride) C Biperiden C Date:06/23/04ISR Number: 4385726-0Report Type:Expedited (15-DaCompany Report #CA_040406864 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angle Closure Glaucoma Foreign Zyprexa Initial or Prolonged Health Zydis-Dispersible Other Professional (Olanzapine) Company (Olanzapine) PS 20 MG Representative Mevacor (Lovastatin) C Other Loxapine C Ativan (Lorazepam) C Date:06/23/04ISR Number: 4385761-2Report Type:Expedited (15-DaCompany Report #EWC040639562 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Foreign Olanzapine-Oral Other (Olanzapine) PS 15 MG/1 DAY Date:06/23/04ISR Number: 4385762-4Report Type:Expedited (15-DaCompany Report #GBS040615046 Age:41 YR Gender:Male I/FU:I Outcome PT Life-Threatening Extrapyramidal Disorder Hospitalization - Musculoskeletal Stiffness Initial or Prolonged Nuchal Rigidity Opisthotonus 24-Jun-2005 12:19 PM Page: 2980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG Professional Venlafaxine C Other Propranolol C Cinnarizine C Date:06/23/04ISR Number: 4385776-4Report Type:Expedited (15-DaCompany Report #GBS040615054 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Neutrophil Count Health (Olanzapine) Decreased Professional (Olanzapine) PS 5 MG Other Date:06/23/04ISR Number: 4386638-9Report Type:Expedited (15-DaCompany Report #USA040669661 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Carcinoma Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 12.5 MG DAY Artane (Trihexyphenidyl Hydrochloride) C Trazodone C Tegretol (Carbamazepine) C Date:06/23/04ISR Number: 4386639-0Report Type:Expedited (15-DaCompany Report #USA040669466 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa-Oral Other Renal Failure Acute Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Date:06/23/04ISR Number: 4386640-7Report Type:Expedited (15-DaCompany Report #USA040669446 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Health Zyprexa-Oral Initial or Prolonged Overdose Professional (Olanzapine) Company (Olanzapine) PS 300 MG Representative Date:06/23/04ISR Number: 4386643-2Report Type:Expedited (15-DaCompany Report #USA040669297 Age:50 YR Gender:Female I/FU:I Outcome PT Death Hernia Refusal Of Treatment By 24-Jun-2005 12:19 PM Page: 2981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Patient Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:06/23/04ISR Number: 4386850-9Report Type:Expedited (15-DaCompany Report #US_0405103066 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Prozac-Oral Initial or Prolonged Alcohol Use Professional (Fluoxetine) Amnesia Other (Fluoxetine Drug Abuser Hydrochloride) PS 20 MG/1 DAY Drug Withdrawal Syndrome Symbyax-Olanzapine Intentional Self-Injury 12mg / Fluoxetine Skin Laceration 25mg (Olanzapi SS 3 WK Suicidal Ideation Zyprexa-Oral Treatment Noncompliance (Olanzapine) (Olanzapine) SS Lithium Carbonate C Furosemide C Kcl (Potassium Chloride) C Mvi (Mvi) C Date:06/23/04ISR Number: 4386852-2Report Type:Expedited (15-DaCompany Report #USA030638832 Age:19 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Agitation Alanine Aminotransferase Increased Alcohol Use Aspartate Aminotransferase Increased Cardiac Murmur Depressed Level Of Consciousness Drug Screen Positive Electrocardiogram Qt Corrected Interval Prolonged Excoriation Haematocrit Decreased Hallucination, Auditory Hallucination, Visual Head Banging Heart Rate Increased Intentional Self-Injury Laceration Multiple Drug Overdose Mydriasis Neurological Examination Abnormal Respiratory Rate 24-Jun-2005 12:19 PM Page: 2982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Scratch Self Injurious Behaviour Somnolence Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Literature Strattera Suicide Attempt Health (Atomoxetine Vomiting Professional Hydrochloride) PS OTHER 1200 MG OTHER White Blood Cell Count Company Olanzapine-Oral Decreased Representative (Olanzapine) SS Oxcarbazepine C Quetiapine C Paroxetine C Albuterol C Montelukast C Ativan (Lorazepam) C Date:06/23/04ISR Number: 4388081-5Report Type:Expedited (15-DaCompany Report #USA040669705 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Strattera Initial or Prolonged Syndrome Professional (Atomoxetine Other Pneumonia Aspiration Hydrochloride) PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS Lexapro (Escitalopram) C Dilantin (Phenytoin Sodium) C Coumadin (Warfarin Sodium) C Tylenol (Paractamol) C Metoprolol C Memantine Hydrochloride C Reminyl (Galantamine Hydrobromide) C Trileptal (Oxcarbazepine) C Bromocrytine Mesylate C Dantrolene C Levaquin (Levofloxacin) C Date:06/24/04ISR Number: 4388773-8Report Type:Expedited (15-DaCompany Report #2004-06-0038 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anorexia Initial or Prolonged Aspartate Other Aminotransferase Increased Blood Lactate Dehydrogenase Increased Cerebral Ischaemia Confusional State Demyelination Depression 24-Jun-2005 12:19 PM Page: 2983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Generalised Anxiety Disorder Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Foreign Intron A (Interferon Insomnia Consumer Alfa-2b Recombinant) Movement Disorder Injectable Solution PS INTRAVENOUS SEE IMAGE Muscle Twitching Zyprexa (Olanzapine) Neutrophil Count Tablets SS ORAL 2.5 - 5 MG Decreased ORAL Nuclear Magnetic Centrum C Resonance Imaging Brain Calcium/Magnesium C Abnormal Imovane C Pain Tylenol C Pain In Extremity Naprosyn C Tremor Weight Decreased White Blood Cell Count Decreased Date:06/28/04ISR Number: 4385897-6Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0335844A Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Co-Amoxiclav PS Glaxosmithkline ORAL 625MG Three Initial or Prolonged Aminotransferase times per day 6 DAY Increased Olanzapine SS ORAL 5MG Per day Blood Alkaline Levothyroxine Sodium C Glaxosmithkline ORAL 100MG Per day Phosphatase Increased Bendrofluazide C Glaxosmithkline ORAL 2.5MG Per day Blood Bilirubin Increased Lorazepam C ORAL Gamma-Glutamyltransferase Zopiclone C ORAL Increased Jaundice Date:06/28/04ISR Number: 4389826-0Report Type:Expedited (15-DaCompany Report #2004040067 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchostenosis Consumer Neurontin Initial or Prolonged Gastrooesophageal Reflux (Gabapentin) PS ORAL 1800 MG (600 Other Disease MG, 3 IN 1 D) Odynophagia ,ORAL Suicidal Ideation Olanzapine (Olanzapine) SS ORAL ORAL Aripiprazole (Aripiprazole) SS ORAL ORAL Valproate Semisodium C Paroxetine Hydrochloride C Clonazepam C Diphenhydramine Hydrochloride C Date:06/29/04ISR Number: 4388074-8Report Type:Direct Company Report #CTU 221755 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Fluphenazine PS ORAL 2.5MG BID Initial or Prolonged Phosphokinase Increased ORAL 24-Jun-2005 12:19 PM Page: 2984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine SS ORAL 10 MG BID ORAL Date:06/29/04ISR Number: 4388194-8Report Type:Direct Company Report #CTU 221757 E Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Olanzapine 15 Mg Initial or Prolonged Lilly PS Lilly ORAL 15 MG HS ORAL Carbamazepine C Nicotine Patches C Acetaminophen C Mylanta C Dulcolax C Benadryl C Date:06/30/04ISR Number: 4389874-0Report Type:Direct Company Report #CTU 221835 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Chest Sound Zyprexa 5 Mg Eli Agitation Lilly And Co. PS Eli Lilly And Co ORAL 5 MG QHS ORAL Apnoea Thyroid C Drug Effect Decreased Oscal C Dyskinesia Miacalcin C Dystonia Plavix C Heart Rate Increased Nacl C Insomnia Date:06/30/04ISR Number: 4414514-1Report Type:Periodic Company Report #2004029193 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Consumer Zoloft (Sertraline) PS Physical Assault Olanzapine Theft (Olanzapine SS Trazodone (Trazodone) SS Date:07/01/04ISR Number: 4391611-0Report Type:Expedited (15-DaCompany Report #US_0406103773 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Consumer Zyprexa-Oral Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS Neonatal Tachypnoea Date:07/01/04ISR Number: 4391641-9Report Type:Expedited (15-DaCompany Report #USA040669980 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Consumer Zyprexa-Oral Initial or Prolonged Pregnancy (Olanzapine) Pregnancy (Olanzapine) PS Zoloft (Sertraline 24-Jun-2005 12:19 PM Page: 2985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:07/01/04ISR Number: 4391644-4Report Type:Expedited (15-DaCompany Report #USA040670098 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa-Oral Chest Pain Professional (Olanzapine) Dizziness (Olanzapine) PS 5 MG/2 DAY Ejection Fraction Decreased Eye Disorder Left Ventricular Failure Mania Nausea Psychotic Disorder Somnolence Tachycardia Vomiting Date:07/01/04ISR Number: 4392001-7Report Type:Expedited (15-DaCompany Report #US_0406103728 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Zyprexa -Oral Initial or Prolonged Body Temperature Professional (Olanzapine)(Olanzap Other Decreased Other ine) PS 20 MG DAY Bradycardia Risperidone C Ill-Defined Disorder Carbamazepine (Carbamazepine) C Trazodone C Fluconazole C Unasyn (Sultamicillin Tosilate) C Date:07/01/04ISR Number: 4392007-8Report Type:Expedited (15-DaCompany Report #USA040670108 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Zyprexa-Oral Initial or Prolonged Renal Failure Professional (Olanzapine) Other Company (Olanzapine) PS 2.5 MG/2 DAY 1 YR Representative Date:07/01/04ISR Number: 4392011-XReport Type:Expedited (15-DaCompany Report #USA040567362 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Symbyax-Olanzapine Other Aspiration Professional 6mg/Fluoxetine 25mg Choking Company (Olanzapin PS Convulsion Representative Depakote (Valproate Derealisation Semisodium) C Mental Disorder Keppra Self-Medication (Levetiracetam) C Treatment Noncompliance Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 2986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Imitrex (Sumatriptan Succinate) C Relpax (Eletriptan Hydrobromide) C Paxil (Paroxetine Hydrochloride) C Date:07/01/04ISR Number: 4393267-XReport Type:Expedited (15-DaCompany Report #AU_040607791 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Foreign Zyprexa-Oral Other Above Therapeutic Health (Olanzapine) Professional (Olanzapine) PS Company Representative Date:07/01/04ISR Number: 4393282-6Report Type:Expedited (15-DaCompany Report #EWC040438722 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa-Oral Initial or Prolonged Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS Drug Exposure Via Breast Other Milk Neonatal Hypoxia Date:07/01/04ISR Number: 4393295-4Report Type:Expedited (15-DaCompany Report #JP_040603436 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocyte Count Foreign Zyprexa-Oral Decreased Health (Olanzapine) PS 15 MG DAY Professional Company Representative Other Date:07/01/04ISR Number: 4393296-6Report Type:Expedited (15-DaCompany Report #JP_040603432 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocyte Count Foreign Zyprexa-Oral Decreased Health (Olanzapine) PS 15 MG DAY White Blood Cell Count Professional Decreased Company Representative Other Date:07/01/04ISR Number: 4393297-8Report Type:Expedited (15-DaCompany Report #GBS040615082 Age:21 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Alkaline Initial or Prolonged Phosphatase Increased 24-Jun-2005 12:19 PM Page: 2987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Musculoskeletal Chest Pain Musculoskeletal Pain Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine -Oral Health (Olanzapine) PS 15 MG DAY Professional Other Date:07/01/04ISR Number: 4393298-XReport Type:Expedited (15-DaCompany Report #FR_040604316 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Zyprexa-Oral Initial or Prolonged Hypertriglyceridaemia Health (Olanzapine) PS Weight Increased Professional Other Date:07/01/04ISR Number: 4393299-1Report Type:Expedited (15-DaCompany Report #EWC040639654 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Exposure During Foreign Zyprexa-Oral Pregnancy Health (Olanzapine) PS Intra-Uterine Death Professional Other Date:07/01/04ISR Number: 4393302-9Report Type:Expedited (15-DaCompany Report #JP_040402955 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa-Oral Initial or Prolonged Delirium Health (Olanzapine) Depressed Level Of Professional (Olanazapine) PS 10 MG/1 AT Consciousness Company BEDTIME Extrapyramidal Disorder Representative Rohypnol Hyponatraemia Other (Flunitrazepam) C Muscle Rigidity Artrane Rhabdomyolysis (Trihexyphenidyl Tremor Hydrochloride) C Water Intoxication Sennoside A+B C Date:07/02/04ISR Number: 4388838-0Report Type:Expedited (15-DaCompany Report #PHBS2004ES08551 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Trileptal PS Novartis Sector: Overdose Professional Pharma ORAL 300 mg/d Trileptal SS Novartis Sector: Pharma ORAL UNK, ONCE/SINGLE Venlafaxine SS Olanzapine SS Noctamid SS 24-Jun-2005 12:19 PM Page: 2988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/04ISR Number: 4389322-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-372165 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Health Peg-Interferon Alfa Initial or Prolonged Loss Of Consciousness Professional 2a (Ro 25-8310) PS Roche SUBCUTANEOUS Ribavirin SS Roche ORAL Zyprexa SS UNKNOWN Zyprexa SS UNKNOWN Remeron SS UNKNOWN Effexor SS UNKNOWN Antabuse SS UNKNOWN Trittico SS UNKNOWN Trittico SS UNKNOWN Methadone C Deanxit C Agopton C Date:07/02/04ISR Number: 4392448-9Report Type:Periodic Company Report #2004UW03243 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Male Sexual Dysfunction Consumer Crestor PS Zyprexa SS Lamictal SS Date:07/02/04ISR Number: 4392624-5Report Type:Expedited (15-DaCompany Report #FRWYE848524JUN04 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Seresta (Oxazepam, Other Professional Tablet, 0) PS ORAL 50 MG 3X PER Other 1 DAY Tranxene (Clorazepate Dipotassium, , 0) SS ORAL Zyprexa (Olanzapine, , 0) SS PARENTERAL 1 DAY Fulmicort (Budesonide) C Dogmatil (Sulpiride) C Foradil (Formoterol Fumarate) C Date:07/06/04ISR Number: 4390174-3Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0336509A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Deroxat PS Glaxosmithkline ORAL 20MG Unknown 1 DAY Initial or Prolonged Drug Toxicity Zyprexa SS ORAL 1 DAY Hyperventilation Havlane SS ORAL 1G per day 1 DAY Miosis Lexomil SS ORAL 1 DAY Equanil SS ORAL 6UNIT per day 1 DAY 24-Jun-2005 12:19 PM Page: 2989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/04ISR Number: 4394489-4Report Type:Expedited (15-DaCompany Report #USA040670554 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Zyprexa-Oral Atrial Fibrillation Professional (Olanzapine) Benign Prostatic Company (Olanzapine) PS 5 MG DAY Hyperplasia Representative Mylanta C Cardiac Failure Aspirin Enteric Congestive Coated K.P. Chronic Obstructive (Acetylalicylic Pulmonary Disease Acid) C Constipation Rocephin Essential Hypertension (Ceftriaxone Sodium) C Gastrooesophageal Reflux Citalopram C Disease Levaquin Insomnia (Levofloxacin) C Muscle Spasms Diphtheria And Pain Tetanus Vaccine Pulmonary Hypertension (Diphtheria And Skin Ulcer Tetanus Toxoids) C Weight Decreased Date:07/06/04ISR Number: 4394994-0Report Type:Expedited (15-DaCompany Report #EWC040438853 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apallic Syndrome Foreign Zyprexa-Oral Life-Threatening Asthenia Health (Olanzapine) PS 2.5 MG/1 DAY Brain Oedema Professional Atenolol C Bronchopneumonia Other Enalapril C Bundle Branch Block Left Indapamide C Cardiac Disorder Bromazepam C Cardio-Respiratory Arrest Dorzolamide C Cerebellar Atrophy Timolol C Cerebral Atrophy Brimonodine C Coma Voltaren (Diclofenac Confusional State Sodium) C Hallucination Hepatic Steatosis Hypoalbuminaemia Hypocalcaemia Mitral Valve Calcification Pulmonary Embolism Quadriplegia Respiratory Failure Tremor Date:07/07/04ISR Number: 4394853-3Report Type:Expedited (15-DaCompany Report #04P-056-0264915-00 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Akineton (Biperiden) Initial or Prolonged Aminotransferase Health (Biperiden) PS ORAL 1 IN 1 D; PER Increased Professional ORAL Pyrexia Olanzapine SS ORAL 1 IN 1 D; PER ORAL Cyamemazine SS ORAL 1 IN 1 D; PER ORAL 24-Jun-2005 12:19 PM Page: 2990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amisulpride C Date:07/08/04ISR Number: 4392683-XReport Type:Expedited (15-DaCompany Report #PHBS2004NO08833 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Leponex PS Novartis Sector: Pharma UNKNOWN Haldol SS Janssen UNKNOWN Chlorpromazine SS UNKNOWN Melleril SS UNKNOWN Nozinan SS UNKNOWN Risperdal SS UNKNOWN Serdolect SS UNKNOWN Sobril SS UNKNOWN Zyprexa SS UNKNOWN Date:07/08/04ISR Number: 4393067-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-373006 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Multiforme Rivotril PS Roche ORAL Initial or Prolonged Fixed Eruption Lexotanil SS Roche ORAL Disability Haldol SS ORAL 1 YR Zyprexa SS ORAL 1 YR Dogmatil SS ORAL Aspirine C ORAL 1 DAY Date:07/08/04ISR Number: 4396613-6Report Type:Expedited (15-DaCompany Report #04P-167-0264813-00 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Divalproex Sodium Intervention to Breast Oedema Health (Depakote) Prevent Permanent Diarrhoea Professional (Divalproex Sodium) Impairment/Damage Difficulty In Walking (Divalproex Sodium) PS ORAL 250 MG, 4 IN Drug Interaction 1 D, PER ORAL Fluid Retention Olanzapine Oedema Peripheral (Olanzapine) SS ORAL 1 IN 1 PER ORAL Date:07/08/04ISR Number: 4397158-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607199 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Haldol Initial or Prolonged Drug Interaction Health (Haloperidol) PS ORAL 10 MG, IN 1 Electrocardiogram Qt Professional DAY, ORAL Corrected Interval Zyprexa (Olanzapine) SS ORAL 15 MG, IN 1 Prolonged DAY, ORAL; 10 Tachycardia MG, IN 1 DAY, ORAL; 20 MG, IN 1 DAY, Diazepam C 24-Jun-2005 12:19 PM Page: 2991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/04ISR Number: 4393714-3Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0516717A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Paxil Cr PS Glaxosmithkline ORAL Zyprexa SS ORAL Date:07/12/04ISR Number: 4397634-XReport Type:Expedited (15-DaCompany Report #DE_000802838 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Zyprexa-Oral Initial or Prolonged Phosphatase Increased Literature (Olanzapine) Disability Blood Pressure Increased Health (Olanzapine) PS 20 M DAY Cognitive Disorder Professional Quilonum - Slow Diabetic Hyperosmolar Other Release (Lithium Coma Carbonate) C Disturbance In Attention Anafranil Gamma-Glutamyltransferase (Clomipramine Increased Hydrochloride) C Hallucinations, Mixed Lethargy Liver Disorder Mental Disorder Due To A General Medical Condition Paraesthesia Paranoia Pneumonia Renal Failure Acute Rhabdomyolysis Vision Blurred Date:07/12/04ISR Number: 4397637-5Report Type:Expedited (15-DaCompany Report #FR_040403838 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa-Oral Other Diet Refusal Health (Olanzapine) Head Injury Professional (Olanzapine) PS 20 MG/1 DAY Intentional Self-Injury Company Zyprexa-Rapid-Acting Medication Error Representative Im (Olanzapine) SS OTHER 10 MG/1 OTHER Mendelson'S Syndrome Other Leponex (Clozapine) C Pulmonary Oedema Flupentixol C Refusal Of Treatment By Patient Suicide Attempt Date:07/12/04ISR Number: 4398733-9Report Type:Expedited (15-DaCompany Report #EWC040639719 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Foreign Zyprexa-Oral Hospitalization - Resuscitation Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 20 MG Disability Company Lithium C Other Representative Depakine (Valproate Other Sodium) C Cisordinol (Clopenthixol 24-Jun-2005 12:19 PM Page: 2992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Psychopax (Diazepam) C Parkemed (Mefenamic Acid) C Date:07/12/04ISR Number: 4398736-4Report Type:Expedited (15-DaCompany Report #EWC040639709 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Infarction Foreign Olanzapine-Oral Disorientation Health (Olanzapine) PS 5 MG Professional Zoloft (Sertraline Other Hydrochloride) C Alprazolam C Date:07/12/04ISR Number: 4398740-6Report Type:Expedited (15-DaCompany Report #JP_040603569 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meige'S Syndrome Foreign Zyprexa-Oral Initial or Prolonged Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Company Representative Other Date:07/12/04ISR Number: 4398742-XReport Type:Expedited (15-DaCompany Report #JP_040603523 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zyprexa-Oral Initial or Prolonged Excitability Study (Olanzapine) Health (Olanzapine) PS 10 MG DAY Professional Biperiden Other Hydrochloride C Lorazepam C Flunitrazepam C Cetraxate Hydrochloride C Zantac (Ranitidine Hydrochloride) C Date:07/12/04ISR Number: 4398743-1Report Type:Expedited (15-DaCompany Report #EWC040639750 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Olanzapine-Oral Hospitalization - Pyrexia Health (Olanzapine) PS 10 MG DAY Initial or Prolonged Professional Clozapine C Company Oxcarbazepine C Representative Zuclopenthixol C Other Bipiriden C Camcolit (Lithium Carbonate) C 24-Jun-2005 12:19 PM Page: 2993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4398745-5Report Type:Expedited (15-DaCompany Report #GBS040615108 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Olanzapine-Oral Initial or Prolonged Aminotransferase Health (Olanzapine) PS 5 MG/1 DAY Increased Professional Co-Amoxiclav C Blood Alkaline Other Levothyroxine Sodium C Phosphatase Increased Bendrofluazide C Blood Bilirubin Increased Lorazepam C Gamma-Glutamyltransferase Zopiclone C Increased Jaundice Date:07/12/04ISR Number: 4398746-7Report Type:Expedited (15-DaCompany Report #JP_040603413 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Oral Infarction Study (Olanzapine) Loss Of Consciousness Health (Olanzapine) PS Professional Lullan (Perospirone Other Hydrochloride) C Akineton (Biperiden Lactate) C Cercine (Diazepam) C Nitorol -Slow Release (Isosorbide Dinitrate) C Isalon (Aldioxa) C Slow-K (Potassium Chloride) C Solita T C Date:07/12/04ISR Number: 4398775-3Report Type:Expedited (15-DaCompany Report #USA040669682 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Evista (Raloxifene Initial or Prolonged Diabetic Ketoacidosis Professional Hydrochloride) PS 60 MG Increased Appetite Company Zyprexa-Oral Nausea Representative (Olanzapine) Respiratory Failure (Olanzapine) SS Tachycardia Zoloft (Sertraline Vomiting Hydrochloride) C Soma (Carisoprodol) C Topamax (Topiramate) C Norvasc (Amlodipine) C Prednisone C Zanaflex (Tizanidine Hydrochloride) C Pamelor (Nortriptyline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 2994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4398789-3Report Type:Expedited (15-DaCompany Report #USA040670361 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Consumer Symbyax-Olanzapine Cough Health 6mg/Fluoxetine 25mg Lethargy Professional (Olanzapin PS Myocardial Infarction Clonopin Productive Cough (Clonazepam) C Zantac (Ranitidine Hydrochloride) C Vitamin B12 C Iron C Date:07/12/04ISR Number: 4398897-7Report Type:Expedited (15-DaCompany Report #JP_040603513 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Study (Olanzapine) Irritability Health (Olanzapine) PS 10 MG/1 DAY Polydipsia Professional Hirnamin Psychiatric Symptom Other (Levomepromazine) C Flumezin (Fluphenazine) C Rohipnol(Flunitrazep am) C Amoban(Zopiclone) C Selbex(Teprenone) C Magnesium Oxide C Pursennid C Gaster D(Famotidine) C Date:07/12/04ISR Number: 4398908-9Report Type:Expedited (15-DaCompany Report #EWC040639724 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Foreign Zyprexa-Rapid-Acting Health Im(Olanzapine) PS 1 DAY Professional Other Date:07/12/04ISR Number: 4398953-3Report Type:Expedited (15-DaCompany Report #US_0406103781 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breath Odour Study Olanzapine-Oral Diabetic Coma Health (Olanzapine) PS 15 MG AT Refusal Of Treatment By Professional BEDTIME Patient Date:07/12/04ISR Number: 4398965-XReport Type:Expedited (15-DaCompany Report #USA040670497 Age:36 YR Gender:Male I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Diabetic Coma Other Metastases To Lung 24-Jun-2005 12:19 PM Page: 2995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metastases To Lymph Nodes Testis Cancer Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG/1 AT BEDTIME Paxil (Paroxetine Hydrochloride) C Lithium C Date:07/12/04ISR Number: 4398969-7Report Type:Expedited (15-DaCompany Report #USA040670557 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Health Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Professional (Olanzapine) Other Syndrome (Olanzapine) PS 5 MG Platelet Count Decreased Diazepam C Thrombosis Date:07/12/04ISR Number: 4398972-7Report Type:Expedited (15-DaCompany Report #USA040670782 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Health Zyprexa-Oral Initial or Prolonged Oedema Peripheral Professional (Olanzapine) Weight Increased Company (Olanzapine) PS Representative Date:07/12/04ISR Number: 4398976-4Report Type:Expedited (15-DaCompany Report #USA040670453 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 40 MG Date:07/12/04ISR Number: 4398980-6Report Type:Expedited (15-DaCompany Report #USA040670467 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Consumer Zyprexa-Oral Initial or Prolonged Drug Ineffective (Olanzapine) Somnolence (Olanzapine) PS 2.5 MG/1 IN Splenomegaly THE EVENING Date:07/12/04ISR Number: 4399377-5Report Type:Expedited (15-DaCompany Report #USA040568383 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Zyprexa Menstruation Irregular Professional Uterine Haemorrhage Company (Olanzapine) PS ORAL 10 MG/1 DAY Weight Increased Representative Paxil Cr (Paroxetine 24-Jun-2005 12:19 PM Page: 2996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Xanax (Alprazolam) C Date:07/13/04ISR Number: 4395808-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-372165 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Peg-Interferon Alfa Initial or Prolonged Epilepsy Professional 2a (Ro 25-8310) PS Roche SUBCUTANEOUS Loss Of Consciousness Ribavirin SS Roche ORAL Zyprexa SS UNKNOWN Zyprexa SS UNKNOWN Remeron SS UNKNOWN Effexor SS UNKNOWN Antabuse SS UNKNOWN Trittico SS UNKNOWN Trittico SS UNKNOWN Methadone C Deanxit C Agopton C Date:07/13/04ISR Number: 4396714-2Report Type:Direct Company Report #CTU 222619 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Olanzapine PS ORAL 10 MG , 10 MG HS, ORAL Date:07/13/04ISR Number: 4398019-2Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040607396 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Haldol (Haloperidol) Increased Health Injection PS INTRAMUSCULAR 10 MG, IN 1 Angiopathy Professional DAY, Aspartate Other INTRA-MUSCULA Aminotransferase R Increased Heminevrin Blood Glucose Increased (Clomethiazole Cardiac Disorder Edisilate) SS ORAL 300 MG, IN 1 Drug Interaction DAY, ORAL Drug Toxicity Zyprexa (Olanzapine) SS 10 MG, IN 1 Pulmonary Oedema DAY Refusal Of Treatment By Stesolid (Diazepam) SS INTRAMUSCULAR 10 MG, IN 1 Patient DAY, Somnolence INTRA-MUSCULA R Cisordinol (Clopenthixol Hydrochloride) SS INTRAMUSCULAR 100 MG, IN 1 DAY, INTRA-MUSCULA R Lithionit (Lithium Sulfate) Sustained Release SS ORAL 0.2 G, IN 1 DAY, ORAL Disipal (Film Coated 24-Jun-2005 12:19 PM Page: 2997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablet) Orphenadrine Hydrochloride C Date:07/14/04ISR Number: 4397337-1Report Type:Expedited (15-DaCompany Report #IT-GLAXOSMITHKLINE-B0338303A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Lamotrigine PS Glaxosmithkline ORAL Initial or Prolonged Hypersensitivity Olanzapine SS ORAL Date:07/14/04ISR Number: 4399725-6Report Type:Expedited (15-DaCompany Report #JP_040603569 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blepharospasm Foreign Zyprexa-Oral Initial or Prolonged Cerebral Ventricle Health (Olanzapine) Dilatation Professional (Olanzapine) PS 15 MG DAY Meige'S Syndrome Company Weight Increased Representative Other Date:07/14/04ISR Number: 4399728-1Report Type:Expedited (15-DaCompany Report #JP_040503161 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Steatosis Foreign Zyprexa Initial or Prolonged High Density Lipoprotein Health (Olanzapine) PS 10 MG DAY Other Decreased Professional Risperdal Hyperphagia Company (Risperidone) C Hypertriglyceridaemia Representative Silece Increased Appetite Other (Flunitrazepam) C Lipoprotein Deficiency Weight Increased Date:07/14/04ISR Number: 4399740-2Report Type:Expedited (15-DaCompany Report #GBS040615054 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disease Recurrence Foreign Zyprexa Epistaxis Health (Olanzapine) PS ORAL 5 MG DAY Neutropenia Professional Other Date:07/14/04ISR Number: 4399742-6Report Type:Expedited (15-DaCompany Report #GBS040514966 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Recurrence Foreign Olanzapine Other Epilepsy Health (Olanzapine) PS ORAL Professional Other 24-Jun-2005 12:19 PM Page: 2998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4399743-8Report Type:Expedited (15-DaCompany Report #FR_040403838 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa Other Mendelson'S Syndrome Health Pulmonary Oedema Professional (Olanzapine) PS ORAL 20 MG/1 DAY Company Zyprexa Representative Rapid-Acting Im Other (Olanzapine) SS INTRAMUSCULAR 10 MG/1 OTHER Leponex (Clozapine) C Flupentixol C Date:07/14/04ISR Number: 4399825-0Report Type:Expedited (15-DaCompany Report #US_0407104035 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Foreign Olanzapine-Oral Idiosyncratic Drug Literature (Olanzapine) PS 5 MG DAY Reaction Health Haloperidol C Priapism Professional Lithium C Other Trihexyphenidyl C Date:07/14/04ISR Number: 4399850-XReport Type:Expedited (15-DaCompany Report #EWC040739828 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Olanzapine-Oral Initial or Prolonged Blood Pressure Increased Health (Olanzapine) PS 2.5 MG/1 Other Dysphagia Professional Zopiclone Lower Respiratory Tract Company (Zopiclone) C Infection Representative Chlorpromazine C Neuroleptic Malignant Other Clonazepam C Syndrome Valproate Sodium C Risperidone C Norfloxacin C Date:07/14/04ISR Number: 4399851-1Report Type:Expedited (15-DaCompany Report #EWC040739819 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Other Date:07/14/04ISR Number: 4399852-3Report Type:Expedited (15-DaCompany Report #EWC040639753 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS Professional Risperdal Consta Company (Risperidone) C Representative Rivotril Other (Clonazepam) C Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 2999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4399853-5Report Type:Expedited (15-DaCompany Report #DE_040613863 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Date:07/14/04ISR Number: 4399854-7Report Type:Expedited (15-DaCompany Report #DE_040613847 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 5 MG DAY Aminotransferase Other Cipramil (Citalopram Increased Hydrobromide) C Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased Date:07/14/04ISR Number: 4399862-6Report Type:Expedited (15-DaCompany Report #AU_040607827 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Fluoxetine Initial or Prolonged Serotonin Syndrome Literature Hydrochloride-Oral Health (Fluoxetine) PS 80 MG DAY 8 WK Professional Olanzapine-Oral Other (Olanzapine) SS 5 MG DAY 3 WK Diazepam C Date:07/14/04ISR Number: 4399876-6Report Type:Expedited (15-DaCompany Report #EWC031137046 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa-Oral Hospitalization - Insomnia Related To Health (Olanzapine) Initial or Prolonged Another Mental Condition Professional (Olanzapine) PS 30 MG/DAY Localised Infection Company Cisordinol-Acutard Mania Representative (Zuclopenthixol Pneumonia Other Acetate) C Cipramil (Citalopram Hydrobromide) C Propavan (Propiomazine Maleate) C Stesolid (Diazepam) C Nozinan (Levomepromazine) C Theralen (Alimemazine Tartrate) C Heminevrin (Clomethiazole Edisilate) C Clonazepam C 24-Jun-2005 12:19 PM Page: 3000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4399878-XReport Type:Expedited (15-DaCompany Report #JP_040402946 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Foreign Zyprexa-Oral Hospitalization - Drug Toxicity Study (Olanzapine) Initial or Prolonged Hyperglycaemia Health (Olanzapine) PS 10 MG DAY Increased Appetite Professional Akineton (Biperiden Insomnia Other Hydrochloride) C Mental Status Changes Mercazole Overdose (Thiamazole) C Red Blood Cell Count Increased Suicidal Ideation Suicide Attempt Weight Increased Date:07/14/04ISR Number: 4399887-0Report Type:Expedited (15-DaCompany Report #EWC021233301 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Zyprexa-Oral Hospitalization - Autoimmune Disorder Literature (Olanzapine) Initial or Prolonged Cerebral Disorder Health (Olanzapine) PS 10 MG DAY Condition Aggravated Professional Omeprazole C Drug Interaction Other Procrin (Leuprorelin Epistaxis Acetate) C Gastrointestinal Disorder Lexatin (Bromazepam) C Gingival Bleeding Zyloric Idiopathic (Allopurinol) C Thrombocytopenic Purpura Iscover (Clopidogrel Intentional Misuse Sulfate) C Melaena Renal Failure Date:07/14/04ISR Number: 4399890-0Report Type:Expedited (15-DaCompany Report #DE_991001633 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Antipsychotic Drug Level Foreign Zyprexa-Oral Hospitalization - Above Therapeutic Literature (Olanzapine) Initial or Prolonged Cardiomyopathy Acute Health (Olanzapine) PS Disability Cardiomyopathy Alcoholic Professional Anafranil Other Drug Interaction (Clomipramine General Physical Health Hydrochloride) C Deterioration Antra (Omeprazole) C Left Ventricular Failure Allopurinol C Pericardial Effusion Pneumonia Pulmonary Congestion Pulmonary Hypertension Therapeutic Agent Toxicity Ventricular Hypokinesia 24-Jun-2005 12:19 PM Page: 3001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4399901-2Report Type:Expedited (15-DaCompany Report #JP_040603413 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Foreign Zyprexa-Oral Unresponsive To Pain Study (Olanzapine) Stimuli Health (Olanzapine) PS Professional Lullan (Perospirone Other Hydrochloride) C Akineton (Biperiden Lactate) C Cercine (Diazepam) C Nitrol - Slow Release (Isosorbide Dinitrate) C Isalon (Aldioxa) C Slow-K (Potassium Chloride) C Solita T C Date:07/14/04ISR Number: 4400014-1Report Type:Expedited (15-DaCompany Report #DE_040613849 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa-Oral Initial or Prolonged Atrial Fibrillation Health (Olanzapine) Blood Potassium Decreased Professional (Olanzapine) PS 15 MG DAY Dehydration Other Haldol (Haloperidol) C Electrocardiogram Qt Diazepam C Prolonged Prescribed Overdose Date:07/14/04ISR Number: 4400016-5Report Type:Expedited (15-DaCompany Report #DE_040613816 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 15 MG DAY Aminotransferase Other Levomepromazine C Increased Haloperidol C Circulatory Collapse Biperiden C Dyspnoea Diazepam C Gamma-Glutamyltransferase Increased Ventricular Fibrillation Date:07/14/04ISR Number: 4400024-4Report Type:Expedited (15-DaCompany Report #DE_040613851 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Zyprexa-Oral Initial or Prolonged Hypotonia Health (Olanzapine) Pleurothotonus Professional (Olanzapine) PS 5 MG IN THE Therapeutic Agent Other EVENING Toxicity Reboxetine C Dominal Forte (Prothipendyl Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sotalol C Enalapril C Dipiperon C Calcium C Vigantoletten (Colecalciferol) C Kalinor (Potassium Chloride) C Acetylsalicylic Acid C Bifiteral (Alctulose) C Date:07/14/04ISR Number: 4400137-7Report Type:Expedited (15-DaCompany Report #US_030493865 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Fall Health (Olanzapine) Hallucination, Auditory Professional (Olanzapine) PS 30 MG/DAY Head Injury Company Benadryl Mammogram Abnormal Representative (Diphenhydramine Multiple Drug Overdose Hydrochloride) C Skin Laceration Lamictal Treatment Noncompliance (Lamotrigine) C Tremor Synthroid (Levothyroxine Sodium) C Avandia (Rosiglitazone Maleate) C Prevacid (Lansoprazole) C Atenolol C Claritin-D C Propanolol C Metformin C Loratadine C Lansoprazole C Simethicone C Cipro (Ciprofloxacin Hydrochloride) C Vicodin C Atenolol C Lescol (Fluvastatin Sodium) C Bactrim Ds C Colace (Docusate Sodium) C Toradol (Ketorolac Tromethamine) C Kefzol (Cefazolin Sodium) C Lipitor (Atorvastatin) C 24-Jun-2005 12:19 PM Page: 3003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4401984-8Report Type:Expedited (15-DaCompany Report #USA030639815 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Strattera Professional (Atomoxetine Company Hydrochloride) PS 80 MG/AT Representative BEDTIME Prozac (Fluoxetine) SS ORAL 80 MG/DAY Zyprexa (Olanzapine) SS ORAL 10 MG/AT BEDTIME Adderall Xr C Nexium C Date:07/14/04ISR Number: 4402039-9Report Type:Expedited (15-DaCompany Report #US_0407104001 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Diastolic Literature Olanzapine-Oral Other Increased Health (Olanzapine) PS 7.5 MG DAY 2 YR Coma Professional Fluoxetine Coronary Artery Hydrochloride-Oral Atherosclerosis (Fluoxetine) SS Dyspnoea Fat Necrosis Hepatic Steatosis Hyperglycaemia Ketoacidosis Pancreatic Enlargement Pancreatitis Necrotising Pulmonary Oedema Respiratory Rate Decreased Skin Odour Abnormal Splenomegaly Date:07/14/04ISR Number: 4402049-1Report Type:Expedited (15-DaCompany Report #US_0407104002 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Literature Olanzapine Other Ketoacidosis Health Pulmonary Oedema Professional (Olanzapine) PS ORAL 7.5 MG DAY 4 MON Date:07/14/04ISR Number: 4402057-0Report Type:Expedited (15-DaCompany Report #USA040671281 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Detachment Consumer Zyprexa Health Zydis-Dispersible Professional (Olanzapine) PS 15 MG AT Other BEDTIME Trazodone C Celexa (Citalopram Hydrobromide) C Mellaril 24-Jun-2005 12:19 PM Page: 3004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Thioridazine Hydrochloride) C Date:07/14/04ISR Number: 4402062-4Report Type:Expedited (15-DaCompany Report #USA040671231 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lipids Increased Health Zyprexa Pancreatitis Professional (Olanzapine) PS ORAL Company Representative Date:07/14/04ISR Number: 4402065-XReport Type:Expedited (15-DaCompany Report #USA040671179 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa Initial or Prolonged Pancreatitis Professional (Olanzapine) PS 30 MG DAY Other Company Lithium C Representative Seroquel (Quetiapine Fumarate) C Date:07/14/04ISR Number: 4402068-5Report Type:Expedited (15-DaCompany Report #USA040671048 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) Other (Olanzapine) PS 10 MG DAY Daily Vitamins C Lasix C Date:07/14/04ISR Number: 4402073-9Report Type:Expedited (15-DaCompany Report #USA040671005 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatic Carcinoma Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Date:07/14/04ISR Number: 4402076-4Report Type:Expedited (15-DaCompany Report #USA040670957 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 3005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/04ISR Number: 4404810-6Report Type:Expedited (15-DaCompany Report #2004040067 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Consumer Neurontin Initial or Prolonged Gastrooesophageal Reflux (Gabapentin) PS ORAL 1800 MG (600 Other Disease MG, 3 IN 1 Odynophagia D), ORAL Suicidal Ideation Olanzapine (Olanzapine) SS ORAL ORAL Aripiprazole (Aripiprazole) SS ORAL ORAL Valproate Semisodium C Paroxetine Hydrochloride C Clonazepam C Diphenhydramine Hydrochloride C Date:07/16/04ISR Number: 4399912-7Report Type:Expedited (15-DaCompany Report #EWC040739844 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar I Disorder Foreign Olanzapine-Oral Other Drug Abuser Health (Olanzapine) PS 15 MG DAY Electrocardiogram St Professional Lithiofor C Segment Elevation Other Dalmadorm Mania (Flurazepam Myocardial Infarction Hydrochloride) C Nausea Rivotril Treatment Noncompliance (Clonazepam) C Vomiting Date:07/16/04ISR Number: 4399916-4Report Type:Expedited (15-DaCompany Report #EWC040739857 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Orthostatic Hypotension Foreign Zyprexa-Oral Hospitalization - Pancytopenia Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 10 MG/1 DAY Other Date:07/16/04ISR Number: 4399921-8Report Type:Expedited (15-DaCompany Report #JP_040603606 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Oesophageal Varices Study (Olanzapine) Haemorrhage Health (Olanzapine) PS 5 MG /1 DAY Professional Herbesser (Diltiazem Other Hydrochloride) C Cytokarma (Cytochrome C) C Cystanin (L-Cysteine Ethyl Ester, Hydrochloride) C Monilac (Lactulose) C 24-Jun-2005 12:19 PM Page: 3006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/04ISR Number: 4400138-9Report Type:Expedited (15-DaCompany Report #US_030494123 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Consumer Zyprexa-Oral Other Distress Syndrome (Olanzapine) Blood Chloride Decreased (Olanzapine) PS Blood Creatinine Prozac-Oral Increased (Fluoxetine) Blood Ph Increased (Fluoxetine Blood Sodium Decreased Hydrochloride) SS 20 MG/2 DAY Blood Urea Increased Depakote (Valproate Cardiac Arrest Semisodium) C Cardio-Respiratory Arrest Prilosec Cerebrovascular Accident (Omeprazole) C Coma Trazodone C Diabetes Mellitus Clonidine C Diabetic Hyperosmolar Neurontin Coma (Gabapantin) C Diabetic Ketoacidosis Verapamil C Disorientation Buspar (Buspirone Disseminated Hydrochloride) C Intravascular Coagulation Risperdal Dysarthria (Risperidone) C Dyspnoea Electroencephalogram Abnormal Epistaxis Fall Fatigue Feeling Abnormal Haemorrhage Head Injury Hyperthermia Hypotension Multi-Organ Failure Pco2 Decreased Pneumonia Polyuria Sepsis Therapy Non-Responder Thirst Urine Output Decreased Ventricular Tachycardia Date:07/16/04ISR Number: 4400182-1Report Type:Expedited (15-DaCompany Report #US_010361601 Age:40 YR Gender:Male I/FU:F Outcome PT Death Acute Respiratory Life-Threatening Distress Syndrome Other Blood Chloride Decreased Blood Creatinine Increased Blood Glucose Increased Blood Sodium Decreased Blood Urea Increased Cardiac Arrest Cardio-Respiratory Arrest Cerebrovascular Accident Coma 24-Jun-2005 12:19 PM Page: 3007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Csf White Blood Cell Count Positive Diabetes Mellitus Report Source Product Role Manufacturer Route Dose Duration Diabetic Hyperosmolar Consumer Zyprexa-Oral Coma Health (Olanazapine) Diabetic Ketoacidosis Professional (Olanzapine) PS 5 MG/DAY 43 DAY Disorientation Company Prozac-Oral Disseminated Representative (Fluoxetine) Intravascular Coagulation (Fluoxetine Dizziness Hydrochloride) SS 20 MG/2 DAY Dysarthria Depakote (Valproate Dyspnoea Semisodium) C Electroencephalogram Prilosec Abnormal (Omeprazole) C Epistaxis Trazadone C Fall Clonidine C Fatigue Neurontin Haemorrhage (Gabapentin) C Head Injury Verapamil C Hyperthermia Buspar (Buspirone Hypotension Hydrochloride) C Malaise Risperdal Multi-Organ Failure (Risperidone) C Pco2 Decreased Pneumonia Polyuria Sepsis Therapy Non-Responder Thirst Urine Output Decreased Ventricular Tachycardia Date:07/16/04ISR Number: 4400183-3Report Type:Expedited (15-DaCompany Report #JP_040503161 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Aspartate Professional (Olanzapine) PS 10 MG DAY Aminotransferase Company Risperdal Increased Representative (Risperidone) C Hepatic Steatosis Other Silece High Density Lipoprotein (Flunitrazepam) C Decreased Hyperphagia Hypertriglyceridaemia Increased Appetite Weight Increased Date:07/16/04ISR Number: 4400184-5Report Type:Expedited (15-DaCompany Report #USA040463754 Age:48 YR Gender:Male I/FU:F Outcome PT Death Abnormal Behaviour Hospitalization - Antipsychotic Drug Level Initial or Prolonged Above Therapeutic Other Aortic Atherosclerosis Apnoea Arrhythmogenic Right 24-Jun-2005 12:19 PM Page: 3008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Dysplasia Coma Coronary Artery Atherosclerosis Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Zyprexa-Oral Hepatic Congestion Professional (Olanzapine) Incontinence (Olanzapine) PS 20 MG DAY Major Depression Mental Impairment Oral Intake Reduced Pericardial Effusion Pulmonary Oedema Pulmonary Vascular Disorder Pulse Absent Rash Refusal Of Treatment By Patient Renal Disorder Urethral Haemorrhage Urethral Injury Weight Decreased Date:07/19/04ISR Number: 4401687-XReport Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0338442A Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Henoch-Schonlein Purpura Augmentin PS Glaxosmithkline ORAL 1G Three Initial or Prolonged times per day 9 DAY Dafalgan SS Glaxosmithkline ORAL 1G Three times per day Oflocet SS INTRAVENOUS 200MG Twice per day 8 DAY Zyrtec SS Glaxosmithkline ORAL 1UNIT Per day Zyprexa SS ORAL 5MG Per day 7 DAY Date:07/19/04ISR Number: 4402014-4Report Type:Direct Company Report #CTU 223037 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Zyprexa 2.5 Mg Lilly PS Lilly ORAL 2.5 MG AT Initial or Prolonged BEDTIME ORAL Date:07/20/04ISR Number: 4404766-6Report Type:Expedited (15-DaCompany Report #B0337868A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Foreign Lithium Salt Intervention to Depression Literature (Formulation Prevent Permanent Erectile Dysfunction Health Unknown) (Generic) Impairment/Damage Muscle Rigidity Professional (Lithium Salt) PS UNKNOWN 1200 MG/PER Priapism DAY/UNKNOWN Therapy Non-Responder Olanzapine Tremor (Formulation Unknown) (Olanzapine) SS UNKNOWN 5MG/PER DAY/UNKNOWN Haloperidol C Benzhexol C 24-Jun-2005 12:19 PM Page: 3009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sildenafil Citrate C Date:07/21/04ISR Number: 4402814-0Report Type:Direct Company Report #USP 56739 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Lilly TABLET D5 1/2 SS INJECTABLE Date:07/21/04ISR Number: 4407169-3Report Type:Expedited (15-DaCompany Report #USA040669466 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Zyprexa-Oral Other Cardiac Arrest Professional (Olanzapine) Electrocardiogram Company (Olanzapine) PS 2.5 MG/1 DAY 4 MON Abnormal Representative Accupril (Quinapril Renal Failure Acute Hydrochloride) C Norvasc (Amlodipine) C Diazide (Gliclazide) C Protonix (Pantoprazole) C Aspirin (Acetylsalicylic Acid) C Xanax (Alprazolam Dum) C Vioxx (Rofecoxib) C Trazadone (Trazodone) C Prednisone C Guanfacine C Synthroid (Levothyroxine Sodium) C Bumex (Bumetanide) C Date:07/21/04ISR Number: 4407171-1Report Type:Expedited (15-DaCompany Report #USA040670497 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Diabetic Coma (Olanzapine) Other Testicular Cancer (Olanzapine) PS 5 MG/1 AT Metastatic BEDTIME Paxil (Paroxetine Hydrochloride) C Lithium C Date:07/21/04ISR Number: 4407253-4Report Type:Expedited (15-DaCompany Report #USA040670557 Age:17 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Ileus Neuroleptic Malignant 24-Jun-2005 12:19 PM Page: 3010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Platelet Count Decreased Thrombosis Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa Oral Professional (Olanzapine) (Olanzapine) PS 5 MG Diazepam C Date:07/21/04ISR Number: 4407342-4Report Type:Expedited (15-DaCompany Report #USA040771875 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Consumer Zyprexa-Oral Initial or Prolonged Psychotic Disorder (Olanzapine) Treatment Noncompliance (Olanzapine) PS Weight Increased Lexapro (Escitalopram Oxalate) C Ativan (Lorazepam) C Date:07/21/04ISR Number: 4407345-XReport Type:Expedited (15-DaCompany Report #USA040771613 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa Oral Hospitalization - Extrapyramidal Disorder Professional (Olanzapine)(Olanzap Initial or Prolonged Multiple Drug Overdose Company ine) PS 15 MG DAY Representative Paxil (Paroxetine Hydrochloride) C Clonopin (Clonazepam) C Haloperdiol C Date:07/21/04ISR Number: 4407346-1Report Type:Expedited (15-DaCompany Report #USA040771756 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Neoplasm Malignant Consumer Zyprexa Oral Other (Olanzapine)(Olanzap ine) PS 5 MG / 3 DAY Nexium (Esomeprazole Magnesium) C Blood Pressure C Ecotrin (Acetylsalicylic Acid) C Date:07/21/04ISR Number: 4407559-9Report Type:Expedited (15-DaCompany Report #DE_040613851 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotonia Foreign Zyprexa-Oral Initial or Prolonged Pleurothotonus Health (Olanzapine) Therapeutic Agent Professional (Olanzapine) PS 5 MG IN THE Toxicity Other EVENING Reboxetine C Dominal Forte 24-Jun-2005 12:19 PM Page: 3011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Prothipendyl Hydrochloride) C Sotalol C Enalapril C Dipiperon C Vigantoletten (Colecalciferol) C Kalinor (Potassium Chloride) C Acetylsalicylic Acid C Bifiteral (Lactulose) C Date:07/21/04ISR Number: 4407596-4Report Type:Expedited (15-DaCompany Report #EWC040639654 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Exposure During Foreign Zyprexa-Oral Pregnancy Health (Olanzapine) Intra-Uterine Death Professional (Olanzapine) PS Other Date:07/21/04ISR Number: 4407676-3Report Type:Expedited (15-DaCompany Report #JP_040503216 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menstruation Irregular Foreign Zyprexa Health (Olanzapine) PS ORAL 10 MG DAY Professional Rhythmy Company (Rilmazafone) C Representative Other Date:07/21/04ISR Number: 4407679-9Report Type:Expedited (15-DaCompany Report #JP_040102565 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Foreign Zyprexa Consciousness Study (Olanzapine) PS ORAL 5 MG/DAY Fall Health Impromen Gait Disturbance Professional (Bromperidol) C Head Injury Other Akineton (Biperiden Hydrochloride) C Doral (Quazepam) C Eurodin (Estazolam) C Depas (Etizolam) C Forsenid (Sennoside A+B) C Pantosin (Pantethine) C Magnesium Oxide Heavy C 24-Jun-2005 12:19 PM Page: 3012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/04ISR Number: 4407681-7Report Type:Expedited (15-DaCompany Report #DE_040413429 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Foreign Zyprexa Lipase Increased Health (Olanzapine) PS ORAL 15 MG DAY Professional Ergenyl Other (Valproate Sodium) C Adumbran (Oxazepam) C Diazepam C Date:07/21/04ISR Number: 4407748-3Report Type:Expedited (15-DaCompany Report #USA040671193 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Consumer Strattera Haematemesis (Atomoxetine Nipple Oedema Hydrochloride) PS 60 MG DAY Nipple Pain Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) SS 10 MG DAY Adderall C Concerta (Methylphenidate Hydrochloride) C Date:07/21/04ISR Number: 4407996-2Report Type:Expedited (15-DaCompany Report #JP_040703723 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Flumezin Representative (Fluphenazine) SS Other Contomin (Chlorpromazine Hydrochloride) C Goodmin (Brotizolam) C Rohipnol (Flunotrazepam) C Date:07/21/04ISR Number: 4407998-6Report Type:Expedited (15-DaCompany Report #EWC040739854 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Multiforme Foreign Olanzapine-Oral Health (Olanzapine) PS 1 YR Professional Rivotril Other (Clonazepam) C Lexotanil (Bromazepam) C Dogmatil (Sulpiride) C Acetylsalicylic Acid C 24-Jun-2005 12:19 PM Page: 3013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/04ISR Number: 4408003-8Report Type:Expedited (15-DaCompany Report #DE_040713898 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG DAY Aminotransferase Other Haldol (Haloperidol Increased Decanoate) C Gamma-Glutamyltransferase Diazepam C Increased Date:07/21/04ISR Number: 4408008-7Report Type:Expedited (15-DaCompany Report #JP_040703713 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Foreign Zyprexa-Oral Jaundice Health (Olanzapine) Upper Respiratory Tract Professional (Olanzapine) PS 20 MG DAY Inflammation Company Flunitrazepam C Representative Other Date:07/21/04ISR Number: 4408032-4Report Type:Expedited (15-DaCompany Report #EWC040539235 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Zyprexa Alanine Aminotransferase Health Increased Professional (Olanzapine) PS ORAL 10 MG/1 DAY Aspartate Company Aminotransferase Representative Increased Other Blood Alkaline Phosphatase Increased Galactorrhoea Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Date:07/21/04ISR Number: 4408034-8Report Type:Expedited (15-DaCompany Report #EWC040639562 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infected Skin Ulcer Foreign Olanzapine Red Blood Cell Count Health (Olanzapine) PS ORAL 15 MG/1 DAY Decreased Professional Depakin Sepsis Other (Valproate Sodium) C Rivotril (Clonazepam) C 24-Jun-2005 12:19 PM Page: 3014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/04ISR Number: 4408036-1Report Type:Expedited (15-DaCompany Report #EWC031137046 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa Hospitalization - Localised Infection Health Initial or Prolonged Mania Professional (Olanzapine) PS ORAL 30 MG/DAY Pneumonia Company Cisorduinol-Acutard Sudden Cardiac Death Representative Upper Respiratory Tract Other (Zuclopenthixol Infection Acetate) C Cipramil (Citalopram Hydrobromide) C Propavan (Propiomazine Maleate) C Stesilid (Diazepam) C Nozinan (Levomepromazine) C Theralen (Alimemazine Tartrate) C Clonazepam C Herminevrin (Clomethiazole Edisilate) C Date:07/22/04ISR Number: 4405175-6Report Type:Direct Company Report #CTU 223309 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activities Of Daily Zyprexa 2.5 Eli Life-Threatening Living Impaired Lilly PS Eli Lilly 1 DAILY Hospitalization - Hypoglycaemia Initial or Prolonged Oedema Disability Tremor Date:07/23/04ISR Number: 4407421-1Report Type:Direct Company Report #CTU 223445 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Zyprexa PS ORAL 5 MG QHS PO Initial or Prolonged Cardio-Respiratory Arrest Seroquel C Coma Synthroid C Convulsion Clonazepam C Heart Rate Decreased Ambien C Pulse Absent Urinary Incontinence Date:07/26/04ISR Number: 4410516-XReport Type:Expedited (15-DaCompany Report #K200401070 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Kemadrin Initial or Prolonged Drug Interaction Health (Procyclidine) Hyponatraemia Professional Tablet, 5mg PS ORAL 5 MG, QD, Polydipsia Other ORAL Water Intoxication Olanzapine 24-Jun-2005 12:19 PM Page: 3015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) 20mg SS ORAL 20 MG, QD,ORAL Methotrimeprazine (Levomepromazine) 12.5mg SS ORAL 12.5 MG, QD,ORAL Date:07/26/04ISR Number: 4434824-1Report Type:Periodic Company Report #US_0404102695 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Apnoea Syndrome Consumer Forteo (Teriparatide) PS 20 UG DAY Zyprexa - Oral (Olanzapine) (Olanzapine) SS Depakote (Valproate Semisodium) C Date:07/27/04ISR Number: 4411445-8Report Type:Expedited (15-DaCompany Report #2004047554 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vascular Purpura Foreign Zyrtec (Tablets) Health (Cetirizine) PS ORAL ORAL Professional Clavulin (Amoxicillin Trihydrate, Clavulanate Potassium) SS ORAL 3 GRAM (1 GRAM, 3 IN 1 D), ORAL Paracetamol (Paracetamol) SS ORAL 3 GRAM (1 GRAM, 3 IN 1 D), ORAL Ofloxacin (Ofloxacin) SS INTRAVENOUS 400 MG (200 MG, 2 IN 1 D), INTRAVENOUS Olanzapine (Olanzapine) SS ORAL 5 MG (5 MG, 1 IN 1 D), ORAL Date:07/27/04ISR Number: 4412799-9Report Type:Expedited (15-DaCompany Report #2004047917 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 MG Initial or Prolonged Bowel Sounds Abnormal 2 IN 1 D) Diarrhoea ORAL Gastrointestinal Disorder Zoloft (Sertraline) SS ORAL 150 MG ( 1 IN 1 D) ORAL Olanzapine (Olanzapine) SS Quetiapine Fumarate (Quetiapine Fumarate) C 24-Jun-2005 12:19 PM Page: 3016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Esomeprazole (Esomeprazole) C Date:07/28/04ISR Number: 4410629-2Report Type:Direct Company Report #CTU 223760 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Zyprexa PS 10 MG UP TO Initial or Prolonged Coma 20 MG Disability Depakote C Required Tegretol C Intervention to Allopurinol C Prevent Permanent Fosinopril C Impairment/Damage Aspirin C Synthroid C Propranolol C Felodine C Date:07/28/04ISR Number: 4411808-0Report Type:Expedited (15-DaCompany Report #USA040670453 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Zyprexa-Oral Drug Toxicity Professional (Olanzapine) PS 40 MG DAY Company Representative Date:07/28/04ISR Number: 4411809-2Report Type:Expedited (15-DaCompany Report #US_030493865 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Consumer Zyprexa-Oral Increased Health (Olanzapine) PS 30 MG/DAY Diabetes Mellitus Professional Benadryl Drug Toxicity Company (Diphenhydramine Fall Representative Hydrochloride) C Hallucination, Auditory Lamictal Liver Function Test (Lamotrigine) C Abnormal Synthroid Overdose (Levothyroxine Skin Laceration Sodium) C Tremor Avandia (Rosiglitazone Maleate) C Prevacid (Lansoprazole) C Atenolol C Claritin-D C Propanolol C Metformin C Loratidine C Lansoprazole C Simethicone C Cipro (Ciprofloxacin Hydrochloride) C Vicodin C Atenolol C Lescol (Fluvastatin 24-Jun-2005 12:19 PM Page: 3017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Bactrim Ds C Colace (Docusate Sodium) C Bactrim Ds C Colace (Docusate Sodium) C Toradol (Ketorolac Tromethamine) C Kefzol (Cefazolin Sodium) C Lipitor (Atorvastatin) C Risperdal (Risperidone) C Hydroxyzine Hydrochloride C Xenical (Orlistat) C Vanceril (Beclometasone Dipropionate) C Albuterol C Date:07/28/04ISR Number: 4413518-2Report Type:Expedited (15-DaCompany Report #USA040670361 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysuria Consumer Symbyax-Olanzapine Lethargy Health 6mg / Fluoxetine Myocardial Infarction Professional 25mg (Olanzapin PS Productive Cough Clonopin (Clonazepam) C Zantac (Ranitidine Hydrochloride) C Vitamin B12 For Injection (Cyanocobalamin) C Iron C Date:07/28/04ISR Number: 4413598-4Report Type:Expedited (15-DaCompany Report #JP_040603413 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Oral Infarction Study (Olanzapine) Loss Of Consciousness Health (Olanzapine) PS 20 MG DAY Professional Lullan (Perospirone Other Hydrochloride) C Akineton (Biperiden Lactate) C Cercine (Diazepam) C Nitorol - Slow Release (Isosorbide Dinitrate) C Isalon (Aldioxa) C Solita T C Slow-Fe (Ferrous Sulfate Exsiccated) C 24-Jun-2005 12:19 PM Page: 3018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/04ISR Number: 4413600-XReport Type:Expedited (15-DaCompany Report #JP_030901737 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Excitability Study (Olanzapine) Restlessness Health (Olanzapine) PS 5 MG/1 DAY Schizophrenia Professional Parkinsonal Suicidal Ideation Other (Trihexyphenidyl Tremor Hydrochloride) C Tm C Halcion (Triazolam) C Rohypnol (Flunitrazepam) C Rize (Clotiazepam) C Haloperidol C Sennoside A+B C Date:07/28/04ISR Number: 4413763-6Report Type:Expedited (15-DaCompany Report #EWC040438734 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Olanzapine-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) PS 20 MG DAY Professional Melleril Other (Thioridazine Hydrochloride) C Temesta (Lorazepam) C Dalmadorm (Flurazepam Hydrochloride) C Biperiden C Date:07/28/04ISR Number: 4413764-8Report Type:Expedited (15-DaCompany Report #DE_040613863 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Truxal (Chloroprothixene Hydrochloride) C Date:07/28/04ISR Number: 4413807-1Report Type:Expedited (15-DaCompany Report #USA040465678 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Zyprexa-Oral Initial or Prolonged Blood Calcium Decreased Health (Olanzapine) Other Contusion Professional (Olanzapine) PS Convulsion Forteo Drug Hypersensitivity (Teriparatide) SS Fall Fosamax (Alendronate Haematoma Sodium) C Loss Of Consciousness Calcium C Celexa (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 3019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/04ISR Number: 4413981-7Report Type:Expedited (15-DaCompany Report #S04-GER-03184-01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Cipramil (Citalopram Initial or Prolonged Status Epilepticus Health Hydrobromide) PS ORAL 60 MG QD PO Suicide Attempt Professional Zyprexa (Olanzapine) SS ORAL 10 MG QD PO Other Date:07/28/04ISR Number: 4414085-XReport Type:Expedited (15-DaCompany Report #EWC040739857 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Orthostatic Hypotension Foreign Zyprexa Hospitalization - Pancytopenia Health (Olanzapine) PS ORAL 10 MG/1 DAY Initial or Prolonged Professional Dorken C Other Date:07/28/04ISR Number: 4414086-1Report Type:Expedited (15-DaCompany Report #FR_040403926 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa Health (Olanzapine) PS ORAL Professional Company Representative Other Date:07/28/04ISR Number: 4438575-9Report Type:Periodic Company Report #USA040360733 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Strattera (Atomoxetine Hydrochloride) SS Concerta (Methylphenidate Hydrochloride) C Date:07/28/04ISR Number: 4439384-7Report Type:Periodic Company Report #USA040465411 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Decreased Appetite (Olanzapine) Suicidal Ideation (Olanzapine) PS 5 MG DAY Tremor Strattera Weight Decreased (Atomoxetine Weight Increased Hydrochloride) SS 40 MG DAY Lexapro (Escitalopram) C Depakote (Valproate Semisodium) C Geodon (Ziprasidone 24-Jun-2005 12:19 PM Page: 3020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:07/28/04ISR Number: 4439457-9Report Type:Periodic Company Report #USA040361436 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Increased Appetite (Atomoxetine Menstrual Disorder Hydrochloride) PS 80 MG DAY Premenstrual Syndrome Zyprexa-Oral Psychomotor Hyperactivity (Olanzapine) Thinking Abnormal (Olanzapine) SS 2.5 MG Date:07/28/04ISR Number: 4439462-2Report Type:Periodic Company Report #USA040361494 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Head Banging Consumer Zyprexa-Oral Somnolence (Olanzapine) Weight Increased (Olanzapine) PS 5 MG DAY Strattera (Atomoxetine Hydrochloride) SS 10 MG/1 DAY Date:07/28/04ISR Number: 4440366-XReport Type:Periodic Company Report #USA040361268 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Communication Disorder Consumer Symbyax-Olanzapine 6 Feeling Abnormal Mg/ Fluoxetine 25 Mg Sluggishness (Olanzapine PS Somnolence Strattera Weight Increased (Atomoxetine Hydrochloride) SS 40 MG DAY Zyprexa (Olanzapine) C Adderall C Date:07/28/04ISR Number: 4440406-8Report Type:Periodic Company Report #USA040362642 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Consumer Strattera (Atomoxetine Hydrochloride) PS 80 MG DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG AT BEDTIME Paxil (Paroxetine Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Albuterol C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 3021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/04ISR Number: 4440481-0Report Type:Periodic Company Report #USA030844301 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Strattera Anorexia (Atomoxetine Expressive Language Hydrochloride) PS Disorder Zyprexa-Oral Eye Rolling (Olanzapine) Fatigue (Olanzapine) SS 5 MG 1 YR Juvenile Arthritis Adderall C Somnolence Folic Acid C Weight Decreased Date:07/28/04ISR Number: 4440495-0Report Type:Periodic Company Report #USA030844309 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Strattera Anorexia (Atomoxetine Expressive Language Hydrochloride) PS Disorder Zyprexa-Oral Eye Rolling (Olanzapine) Fatigue (Olanzapine) SS Juvenile Arthritis Adderall C Somnolence Folic Acid C Weight Decreased Date:07/28/04ISR Number: 4440703-6Report Type:Periodic Company Report #USA040258370 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa-Oral Dizziness (Olanzapine) Erectile Dysfunction (Olanzapine) PS 10 MG DAY Headache Strattera Heart Rate Increased (Atomoxetine Hyperhidrosis Hydrochloride) SS 60 MG DAY Paranoia Lorazepam C Peripheral Coldness Pruritus Urticaria Date:07/28/04ISR Number: 4440902-3Report Type:Periodic Company Report #USA040465865 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Strattera Drug Ineffective (Atomoxetine Dry Mouth Hydrochloride) PS 40 MG/2 DAY Hypotension Zyprexa-Oral Muscle Spasms (Olanzapine) Nervousness (Olanzapine) SS 5 MG/1 DAY Pallor Klonopin Restless Legs Syndrome (Clonazepam) C Tremor Lamictal (Lamotrigine) C Oxazepam C Wellbutrin 24-Jun-2005 12:19 PM Page: 3022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bupropion Hydrochloride) C Date:07/28/04ISR Number: 4441196-5Report Type:Periodic Company Report #USA040464001 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Hypertension (Atomoxetine Intraocular Pressure Hydrochloride) PS 18 MG DAY Increased Symbyax-Olanzapine 6mg / Fluoxetine 25mg (Olanzapin SS Lotensin (Benazepril Hydrochloride) SS Flonase (Fluticasone Propionate) C Penta-Triamterene Hctz C Ditropan Xl (Oxybutynin Hydrochloride) C Pravachol (Pravastatin Sodium) C Prevacid (Lansoprazole) C Ambien (Zolpidem Tartrate) C Restoril (Temazepam) C Aspirin C Vitamins C Date:07/28/04ISR Number: 4441542-2Report Type:Periodic Company Report #USA040156251 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Strattera Initial or Prolonged Anger (Atomoxetine Crying Hydrochloride) PS 40 MG/DAY Drug Ineffective Zyprexa-Oral Mood Swings (Olanzapine) Tic (Olanzapine) SS 5 MG/IN THE Weight Increased MORNING Ability (Aripiprazole) C Trileptal (Oxcarbazepine) C Seroquel (Quetiapine Fumarate) C Lexapro (Escitalopram) C Singulair (Montelukast Sodium) C 24-Jun-2005 12:19 PM Page: 3023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/04ISR Number: 4441553-7Report Type:Periodic Company Report #USA040155894 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa - Oral Blood Pressure Increased Health (Olanzapine) Decreased Appetite Professional (Olanzapine) PS 2 WK Dizziness Strattera Drug Effect Decreased (Atomoxetine Heart Rate Increased Hydrochloride) SS 60 MG DAY Homicidal Ideation Depakote (Valproate Peripheral Coldness Semisodium) C Poor Peripheral Tegretal Circulation (Carbamazepine) C Prescribed Overdose Tachycardia Date:07/28/04ISR Number: 4441579-3Report Type:Periodic Company Report #USA040362401 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Consumer Zyprexa-Oral(Olanzap Weight Increased ine)(Olanzapine) PS 2 WK Strattera (Atomoxetine Hydrochloride) SS 2 YR Lithium C Thyroid C Date:07/28/04ISR Number: 4441582-3Report Type:Periodic Company Report #USA040362331 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral(Olanzap Initial or Prolonged Drug Ineffective ine()Olanzapine) PS 2.5 MG/2 DAY 2 MON Weight Increased Strattera (Atomoxetine Hydrochloride) SS 25 MG DAY 3 MON Ritalin La (Methylphenidate Hydrochloride) C Focalin C Date:07/28/04ISR Number: 4441586-0Report Type:Periodic Company Report #USA040361534 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Symbyax-Olanzapine Drug Ineffective Professional 6mg/Fluoxetine Loss Of Consciousness Company 25mg(Olanzapin PS 1 DSG FORM/1 Representative DAY Strattera (Atomoxetine Hydrochloride) SS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Ortho Tri-Cyclen C 24-Jun-2005 12:19 PM Page: 3024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C Date:07/28/04ISR Number: 4441595-1Report Type:Periodic Company Report #USA040361307 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa Initial or Prolonged Haematemesis Health Zydis-Dispersible Hallucinations, Mixed Professional (Olanzapine)(Olanzap Hunger ine) PS 5 MG/2 DAY Intentional Self-Injury Celexa (Citalopram Psychomotor Hyperactivity Hydrobromide) C Suicidal Ideation Ritalin Weight Increased (Methylphenidate Hydrochloride) C Trileptal (Oxcarbazepine) C Ranitidine C Clonidine C Date:07/29/04ISR Number: 4411002-3Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-11924974 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Modecate PS Apothecon INTRAMUSCULAR Date stated: Hospitalization - Central Pontine long-term Initial or Prolonged Myelinolysis Ameride SS ORAL 5/50 mg Other Coma Zyprexa SS ORAL Drug Interaction Zyprexa SS Hyponatraemia Tranxilium C ORAL Date stated: Vomiting long-term Date:07/29/04ISR Number: 4411689-5Report Type:Direct Company Report #CTU 223825 Age:4 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Exposure During Zyprexa 20 Mg PS ORAL 20 MG PER DAY Congenital Anomaly Pregnancy ORAL Nystagmus Zoloft 100 Mg SS ORAL 50 MG TWICE A Optic Nerve Hypoplasia DAY ORAL Visual Acuity Reduced Date:07/29/04ISR Number: 4443969-1Report Type:Periodic Company Report #US-JNJFOC-20030704993 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Risperdal Initial or Prolonged Increased Professional (Risperidone) Musculoskeletal Stiffness Company Tablets PS ORAL ORAL Neuroleptic Malignant Representative Paxil (Paroxetine Syndrome Hydrochloride) SS Tachycardia Geodon (Ziprasidone Hydrochloride) SS 60 MG, 2 IN 1 DAY Zyprexa (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 3025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444107-1Report Type:Periodic Company Report #USA-2003-0009573 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Morphine Sulfate Multiple Drug Overdose Professional (Morphine Sulfate) PS Other Heroin (Diamorphine) SS Paxil (Paroxetine Hydrochloride) SS Chlorpromazine (Chlorpromazine) SS Zyprexa (Olanzapine) SS Clonazepam (Clonazepam) SS Insulin C Date:07/29/04ISR Number: 4445374-0Report Type:Periodic Company Report #2003UW12274 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Elavil PS Health Olanzapine SS Professional Ethanol SS Alcohol C Date:07/30/04ISR Number: 4415634-8Report Type:Expedited (15-DaCompany Report #2004UW15662 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Seroquel PS ORAL 100 MG TID PO Decreased Appetite Professional Abilify SS Sleep Disorder Zyprexa SS Paxil SS Zantac SS Date:07/30/04ISR Number: 4416149-3Report Type:Expedited (15-DaCompany Report #S04-BEL-03332-01 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Foreign Memantine PS Haemorrhagic Stroke Consumer Aricept (Donepezil Other Hydrochloride) SS ORAL 5 MG QD PO Zyprexa (Olanzapine) SS ORAL 2 MG PRN PO Vitamin E /Gfr/(Vegetable Oil) SS 2000 IU QD Date:08/02/04ISR Number: 4413092-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-375534 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Consumer Rivotril PS Roche ORAL 1 DAY Electrocardiogram Qt Prozac SS ORAL 4 DAY Corrected Interval Tercian SS ORAL 1 DAY Prolonged Zyprexa SS ORAL 1 DAY Extrasystoles Somnolence 24-Jun-2005 12:19 PM Page: 3026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/04ISR Number: 4414977-1Report Type:Direct Company Report #CTU 224100 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradykinesia Zyprexa 20mg Lilly PS Lilly ORAL 20MG QHS Dystonia ORAL Acetaminophen C Buspirone C Depakote C Omeprazole C Warfarin C Date:08/03/04ISR Number: 4418036-3Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040607396 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Haldol (Haloperidol) Increased Health Injection PS INTRAMUSCULAR 10 MG, IN 1 Aspartate Professional DAY, Aminotransferase INTRA-MUSCULA Increased R Cardiomegaly Heminevrin Drug Toxicity (Clomethazole Gamma-Glutamyltransferase Edisilate) Capsules SS ORAL 300 MG, IN 1 Increased DAY, ORAL Hyperaemia Zyprexa (Olanzapine) Pulmonary Oedema Injection SS 10 MG, IN 1 Refusal Of Treatment By DAY, Patient Stesolid (Diazepam) Somnolence Injection SS INTRAMUSCULAR 10 MG, 1 IN DAY, INTRA-MUSCULA R Cisordinol (Clopenthixol Hydrochloride) Injection SS INTRAMUSCULAR 100 MG, IN 1 DAY, INTRA-MUSCULA R Lithionit (Lithium Sulfate) Sustained Release Tablets SS ORAL 0.2 G, IN 1 DAY, ORAL Disipal (Film Coated Tablet) Orphenadrine Hydrochloride C Date:08/04/04ISR Number: 4415972-9Report Type:Direct Company Report #CTU 224279 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Zyprexa 5 Mg Eli Increased Lilly PS Eli Lilly ORAL 3 3 TIMES Obesity ORAL Weight Increased Clonazepam C Paxil C Ambien C Buspar C 24-Jun-2005 12:19 PM Page: 3027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/04ISR Number: 4419679-3Report Type:Expedited (15-DaCompany Report #JP_040703759 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fall Foreign Zyprexa-Oral Head Injury Study (Olanzapine) Headache Health (Olanzapine) PS 5 MG/1 DAY Hypertension Professional Serenace Loss Of Consciousness Other (Haloperidol) C Artane (Trihexyphenidyl Hydrochloride) C Magnesium Oxide C Adalat (Nifedipine) C Diovan C Date:08/04/04ISR Number: 4419680-XReport Type:Expedited (15-DaCompany Report #US_0407104340 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Zyprexa-Oral Alopecia (Olanzapine) Cardiac Disorder (Olanzapine) PS Epistaxis Gynaecomastia Skin Ulcer Somnolence Weight Increased Date:08/04/04ISR Number: 4419758-0Report Type:Expedited (15-DaCompany Report #US_0407104167 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Olanzapine-Oral Initial or Prolonged Bipolar I Disorder Literature (Olanzapine) PS 5 MON Delusion Of Reference Other Valproate Sodium C Hallucination, Auditory Hallucination, Olfactory Obsessive-Compulsive Disorder Persecutory Delusion Refusal Of Treatment By Patient Suicidal Ideation Date:08/04/04ISR Number: 4419766-XReport Type:Expedited (15-DaCompany Report #JP_040603281 Age:44 YR Gender:Male I/FU:I Outcome PT Life-Threatening Adjustment Disorder Hospitalization - Chemical Poisoning Initial or Prolonged Condition Aggravated Convulsion Depressed Level Of Consciousness Drug Abuser Hepatitis B Hyponatraemia Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 3028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Water Intoxication Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Company Meilax (Ethyl Representative Loflazepate) C Other Benzalin (Nitrazepam) C Date:08/04/04ISR Number: 4419770-1Report Type:Expedited (15-DaCompany Report #JP_040703826 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Depressed Level Of Health (Olanzapine) Consciousness Professional (Olanzapine) PS 3.75 MG AT Vomiting Company BEDTIME Representative Serenace Other (Haloperidol) C Risperdal (Risperidone) C Date:08/04/04ISR Number: 4419878-0Report Type:Expedited (15-DaCompany Report #US_0407104156 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Olanzapine-Oral Initial or Prolonged Anhedonia Literature (Olanzapine) PS 20 MG/DAY A Apathy Health FEW MONTHS Crying Professional Lithium C Decreased Interest Other Depressed Mood Feelings Of Worthlessness Hallucination, Auditory Obsessive-Compulsive Disorder Persecutory Delusion Psychomotor Retardation Psychotic Disorder Suicidal Ideation Tension Thinking Abnormal Date:08/04/04ISR Number: 4419889-5Report Type:Expedited (15-DaCompany Report #DE_040713949 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 10 MG/1 DAY Professional Haldol-Janssen Company Decanoat Representative (Haloperidol Other Decanoate) C 24-Jun-2005 12:19 PM Page: 3029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/04ISR Number: 4420065-0Report Type:Expedited (15-DaCompany Report #CA_040707125 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Foreign Zyprexa-Oral Initial or Prolonged Bedridden Consumer (Olanzapine) Other Brain Damage Other (Olanzapine) PS 10 MG DAY Convulsion Fall Grand Mal Convulsion Loss Of Consciousness Movement Disorder Somnolence Weight Decreased Weight Increased Date:08/04/04ISR Number: 4420071-6Report Type:Expedited (15-DaCompany Report #EWC040739922 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Olanzapine-Oral Initial or Prolonged Hyponatraemia Health (Olanzapine) PS 20 MG/1 DAY Polydipsia Professional Levopromazin C Water Intoxication Other Kemadrin (Procyclidine Hydrochloride) C Date:08/04/04ISR Number: 4420076-5Report Type:Expedited (15-DaCompany Report #FR_040704427 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine) Status Epilepticus Professional (Olanzapine) PS 5 MG/2 DAY Other Rivotril (Clonazepam) C Leticur (Tropatepine Hydrochloride) C Forlax (Macrogol) C Date:08/04/04ISR Number: 4421215-2Report Type:Expedited (15-DaCompany Report #FR_040704436 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 20 MG DAY Electrocardiogram Qt Company Tegretol Prolonged Representative (Carbamazepine) C Other Seresta (Oxazepam) C Zoloft (Sertraline Hydrochloride) C Imovane (Zopiclone) C 24-Jun-2005 12:19 PM Page: 3030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/04ISR Number: 4421218-8Report Type:Expedited (15-DaCompany Report #GBS040715212 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Increased Foreign Olanzapine-Oral Initial or Prolonged Hepatitis Acute Health (Olanzapine) PS 10 MG Professional Olanzapine-Rapid-Act Other ing Im SS Zolpidem C Lorazepam C Date:08/04/04ISR Number: 4421987-7Report Type:Expedited (15-DaCompany Report #USA040772222 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Consumer Zyprexa-Oral Chest Pain (Olanzapine) Diabetes Mellitus (Olanzapine) PS Dyspnoea Exertional Prozac (Fluoxetine Increased Appetite Hydrochloride) C Weight Increased Thyroid C Date:08/04/04ISR Number: 4421990-7Report Type:Expedited (15-DaCompany Report #USA040772172 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Other Pancreatitis Acute Professional (Olanzapine) Company (Olanzapine) PS Representative Concerta (Methylphenidate Hydrochloride) C Date:08/04/04ISR Number: 4421992-0Report Type:Expedited (15-DaCompany Report #USA040772112 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Dizziness (Olanzapine) Drug Interaction (Olanzapine) PS Loss Of Consciousness Oxycodone C Restlessness Date:08/04/04ISR Number: 4421993-2Report Type:Expedited (15-DaCompany Report #USA040772581 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 25 MG DAY Representative 24-Jun-2005 12:19 PM Page: 3031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/04ISR Number: 4421994-4Report Type:Expedited (15-DaCompany Report #USA040772599 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Crying Health Zyprexa-Oral Drug Toxicity Professional (Olanzapine) Dysuria (Olanzapine) PS 30 MG DAY Klonopin (Clonazepam) C Artane (Trihexyphenidyl Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Tramadol (Tramadol) C Date:08/06/04ISR Number: 4421689-7Report Type:Expedited (15-DaCompany Report #US_030795917 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Consumer Zyprexa-Oral Initial or Prolonged Cataract Nuclear Health (Olanzapine) Other Cerebrovascular Accident Professional (Olanzapine) PS 5 MG/DAY Colonic Polyp Lopid (Gemfibrozil C Diabetes Mellitus Valium (Diazepam) C Non-Insulin-Dependent Aspirin C Dilatation Atrial (E.C.) Diverticulum (Acetylsalicylic Fatigue Acid) C Gastrointestinal Gluctorol Xl Haemorrhage (Glipizide) C Glycosylated Haemoglobin Accupril (Quinapril Increased Hydrochloride) C Haematocrit Decreased Hydrochlorothiazide C Haemorrhoidal Haemorrhage Glucophage Intervertebral Disc (Metformin Displacement Hydrochloride) C Ketoacidosis Lipitor Macular Degeneration (Atorvastatin) C Pancreatitis Toprol Xl Photophobia (Metoprolol Pneumonia Mycoplasmal Succinate) C Prothrombin Time Xanax (Alprazolam) C Prolonged Demerol (Pethidine Radiculopathy Hydrochloride) C Red Blood Cell Count Heparin C Decreased Tylox C Somnolence Stomatitis Treatment Noncompliance Ventricular Hypertrophy Visual Acuity Reduced Weight Increased Date:08/06/04ISR Number: 4421691-5Report Type:Expedited (15-DaCompany Report #USA040772599 Age:57 YR Gender:Male I/FU:F Outcome PT Death Accident Bladder Disorder 24-Jun-2005 12:19 PM Page: 3032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Crying Drug Toxicity Dysuria Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG DAY Klonopin (Clonazepam) C Artane (Trihexyphenidyl Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Tramadol (Tramadol) C Date:08/06/04ISR Number: 4421755-6Report Type:Expedited (15-DaCompany Report #USA031049346 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Literature Zyprexa-Oral Disease Recurrence Health (Olanzapine) Dizziness Professional (Olanzapine) PS ORAL 7.5 MG DAY Drug Intolerance Coumadin (Warfarin Leukocytoclastic Sodium) C Vasculitis Date:08/06/04ISR Number: 4421758-1Report Type:Expedited (15-DaCompany Report #USA040464193 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Zyprexa-Oral Breast Cancer Professional (Olanzapine) PS ORAL 25 MG DAY Prescribed Overdose Company Mellaril Representative (Thioridazine Hydrochloride) C Date:08/06/04ISR Number: 4421766-0Report Type:Expedited (15-DaCompany Report #USA040773147 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Disorder Health Strattera Headache Professional (Atomoxetine Mydriasis Hydrochloride) PS 25 MG DAY Optic Atrophy Zyprexa-Oral Photosensitivity Reaction (Olanzapine) Tardive Dyskinesia (Olanzapine) SS 5 MG DAY Metadate Cd (Methylphenidate Hydrochloride) C Date:08/06/04ISR Number: 4421848-3Report Type:Expedited (15-DaCompany Report #FR_040704475 Age: Gender:Male I/FU:I Outcome PT Congenital Anomaly Calcinosis Cerebral Disorder Cerebral Palsy 24-Jun-2005 12:19 PM Page: 3033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congenital Varicella Infection Drug Exposure During Report Source Product Role Manufacturer Route Dose Duration Pregnancy Foreign Zyprexa-Oral Neonatal Disorder Health (Olanzapine) Retinitis Professional (Olanzapine) PS Other Date:08/06/04ISR Number: 4421886-0Report Type:Expedited (15-DaCompany Report #2004AP03978 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Seroquel PS Health Zyprexa SS ORAL 20 MG DAILY Professional PO Other Date:08/06/04ISR Number: 4422258-5Report Type:Expedited (15-DaCompany Report #USA040773125 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Renal Failure Acute Professional (Olanzapine) Company (Olanzapine) PS 20 MG DAY Representative Date:08/06/04ISR Number: 4422265-2Report Type:Expedited (15-DaCompany Report #USA040773025 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 15 MG DAY Singulair (Montelukast)) C Trileptal (Oxcarbazepine) C Date:08/06/04ISR Number: 4422271-8Report Type:Expedited (15-DaCompany Report #USA040773134 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retinal Haemorrhage Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Lorazepam C Geodon (Ziprasidone Hydrohloride) C Paroxetine C Estrogen Nos C 24-Jun-2005 12:19 PM Page: 3034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4422279-2Report Type:Expedited (15-DaCompany Report #USA040773146 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS Date:08/06/04ISR Number: 4422449-3Report Type:Expedited (15-DaCompany Report #USA040772833 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident At Work Consumer Zyprexa-Oral Initial or Prolonged Cardiac Disorder (Olanzapine) Other Diabetes Mellitus (Olanzapine) PS 15 MG DAY Drug Ineffective Hydrochlorothiazide C Intervertebral Disc Elavil Injury (Amitriptyline Renal Disorder Hydrochloride) C Xanax (Alprazolam Dum) C Morphine C Insulin C Amaryl (Glimepiride) C Date:08/06/04ISR Number: 4423062-4Report Type:Expedited (15-DaCompany Report #USA040773244 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG DAY Lanoxin (Digoxin) C Naprosyn (Naproxen Mepha) C Tylenol (Paracetamol) C Date:08/06/04ISR Number: 4423510-XReport Type:Expedited (15-DaCompany Report #GBS040715248 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Olanzapine-Oral Prolonged Health (Olanzapine) PS 20 MG Professional Ferrous Sulphate C Other Microgynon C Date:08/06/04ISR Number: 4423787-0Report Type:Expedited (15-DaCompany Report #FR_040303830 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa Health Olanzapine) PS ORAL 30 MG/1 OTHER Professional Diuretic C Company Haldol (Haloperiodl) C Representative Tercian Other (Cyamemazine) C Unspecified 24-Jun-2005 12:19 PM Page: 3035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic C Date:08/06/04ISR Number: 4423789-4Report Type:Expedited (15-DaCompany Report #GBS040615082 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Olanzapine Initial or Prolonged Blood Alkaline Health Other Phosphatase Increased Professional (Olanzapine) PS ORAL 15 MG DAY Chest Pain Other Musculoskeletal Pain Date:08/06/04ISR Number: 4423909-1Report Type:Expedited (15-DaCompany Report #EWC040539350 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa-Rapid-Acting Pulmonary Oedema Health Im(Olanzapine) PS 10 MG Professional Tavor(Lorazepam) C Company Talofen(Promazine Representative Hydrochloride) C Seroquel(Quetiapine Fumarate) C Date:08/06/04ISR Number: 4423910-8Report Type:Expedited (15-DaCompany Report #EWC040639724 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Zyprexa-Rapid-Acting Blood Pressure Health Im (Olanzapine) PS 10 MG/2 DAY 1 DAY Immeasurable Professional Midazolam C Pulmonary Embolism Other Haloperidol C Pulse Absent Biperiden C Clonazepam C Date:08/06/04ISR Number: 4423911-XReport Type:Expedited (15-DaCompany Report #EWC040639753 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS Professional Risperdal Company Consta(Risperidone) C Representative Rivotril(Clonazepam) C Other Risperdal(Risperidon e) C Date:08/06/04ISR Number: 4423912-1Report Type:Expedited (15-DaCompany Report #EWC040438734 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Olanzapine-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) PS 20 MG DAY Professional Melleril(Thioridazin Other e Hydrochloride) C Temesta(Lorazepam) C Dalmadorm(Flurazepam 24-Jun-2005 12:19 PM Page: 3036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Biperiden C Date:08/06/04ISR Number: 4423913-3Report Type:Expedited (15-DaCompany Report #EWC010928299 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa (Olanzapine) PS 10 MG/DAY Study Depamide(Valpromide) C Health Tranxene(Clorazepate Professional Dipotassium) C Other Ludiomil(Maprotiline Hydrochloride) C Parkinane(Trihexyphe nidyl Hydrochloride) C Date:08/06/04ISR Number: 4423997-2Report Type:Expedited (15-DaCompany Report #DE_040713971 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Zyprexa-Oral Hospitalization - Syndrome Health (Olanzapine) Initial or Prolonged Serotonin Syndrome Professional (Olanzapine) PS 20 MG/DAY Company Remergil Representative (Mirtazapine) C Other Cipramil (Citalopram Hydrobromide) C Dapotum (Fluphenazine Hydrochloride) C Tavor(Lorazepam) C Date:08/06/04ISR Number: 4424003-6Report Type:Expedited (15-DaCompany Report #AU_040707917 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa-Oral Health (Olanzapine) PS 40MG/1 DAY Professional Company Representative Other Date:08/06/04ISR Number: 4424005-XReport Type:Expedited (15-DaCompany Report #AU_040707911 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa-Oral Health (Olanzapine) PS 5 MG DAY Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 3037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4435275-6Report Type:Direct Company Report #CTU 225698 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Zyprexa 2.5 Mg, 5 Intervention to Abnormal Mg, & 10 Mg Lilly PS Lilly SEE IMAGE Prevent Permanent Novolin 70/30 C Impairment/Damage Glucerna C Duragesic C Furosemide C Kcl C Diltiazem C Xalatan C Metoprolol C Alphagan C Prevacid C Theravite C Feso4 C Ascorbic Acid C Docusate C Lovenox C Aspirin C Date:08/09/04ISR Number: 4418267-2Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0494734A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anhedonia Paxil Cr PS Glaxosmithkline ORAL 12.5MG At Drug Ineffective night Lethargy Zyprexa SS ORAL 5MG At night Sedation Wellbutrin Sr C Glaxosmithkline ORAL 150MG In the morning Date:08/09/04ISR Number: 4421581-8Report Type:Direct Company Report #CTU 224555 Age:75 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Percocet PS 5 MG PRIOR TO Initial or Prolonged Confusional State HOSPITALIZATI Snoring ON Tigan SS PRN PRIOR TO HOSPITALIZATI ON Ativan SS 1 MG TID PRIOR TO HOSPITALIZATI ON Doxepin SS 50 MG BID PRIOR TO HOSPITALIZATI ON Diazepam SS 5MG QHS PRIOR TO HOSPITALIZATI ON Zyprexa SS 10 MG QD PRIOR TO HOSPITALIZATI ON 24-Jun-2005 12:19 PM Page: 3038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/04ISR Number: 4422046-XReport Type:Expedited (15-DaCompany Report #USA040773111 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa-Rapid-Acting Professional Im (Olanzapine) PS 10 MG Company Zyprexa-Oral Representative (Olanzapine (Olanzapine) SS 30 MG DAY Risperdal (Risperidone) C Ativan (Lorazepam) C Date:08/09/04ISR Number: 4422966-6Report Type:Direct Company Report #CTU 224576 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Headache Olanzapine 5-20 Mg PS ORAL PO HS Hospitalization - Hyperglycaemia Initial or Prolonged Mental Status Changes Polydipsia Polyuria Date:08/11/04ISR Number: 4426063-5Report Type:Expedited (15-DaCompany Report #GBS040715232 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zyprexa-Oral Liver Function Test Health (Olanzapine) Abnormal Professional (Olanzapine) PS 10 MG DAY Company Seroxat (Paroxetine Representative Hydrochloride) C Other Acamprosate C Methotrexate C Date:08/11/04ISR Number: 4426154-9Report Type:Expedited (15-DaCompany Report #USA040670497 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Consumer Zyprexa Initial or Prolonged Increased (Olanzapine) PS ORAL 5 MG/1 AT Other Diabetes Mellitus BEDTIME Diabetic Coma Paxil (Paroxetine Metastases To Lung Hydrochloride) C Metastases To Lymph Nodes Lithium C Testis Cancer Tricor (Fenofibrate) C Lisinopril (Lisinopril) C Lantus (Insulin Glargine) C Humalog C Date:08/11/04ISR Number: 4426167-7Report Type:Expedited (15-DaCompany Report #USA040465685 Age:41 YR Gender:Male I/FU:F Outcome PT Other Cardiomyopathy Chest Discomfort 24-Jun-2005 12:19 PM Page: 3039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cough Dyspnoea Dyspnoea Exertional Report Source Product Role Manufacturer Route Dose Duration Hypoxia Health Zyprexa-Oral Pericardial Effusion Professional (Olanzapine) Pericarditis (Olanzapine) PS 7.5 MG DAY Ventricular Hypertrophy Lexapro (Escitalopram) C Date:08/11/04ISR Number: 4426183-5Report Type:Expedited (15-DaCompany Report #USA040773670 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Memory Impairment (Olanzapine) Sleep Walking (Olanzapine) PS Date:08/11/04ISR Number: 4426224-5Report Type:Expedited (15-DaCompany Report #EWC040539355 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa- Cardiovascular Disorder Health Rapid-Acting Im Professional (Olanzapine) PS 30 MG DAY Company Tavor (Lorazepam) C Representative Largactil (Chlorpromazine Hydrochloride) C Talofen (Promazine Hydrochloride) C Farganesse (Promethazine Hydrochloride) C Date:08/11/04ISR Number: 4426225-7Report Type:Expedited (15-DaCompany Report #EWC040639753 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sedation Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 10 MG Professional Risperdal Consta Company (Risperidone) C Representative Rivotril (Clonazepam) C Risperdal (Risperidone) C Tranxilium (Clorazepate Dipotassium) C Depakine (Valproate Sodium) C 24-Jun-2005 12:19 PM Page: 3040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/04ISR Number: 4426421-9Report Type:Expedited (15-DaCompany Report #DE_040714008 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lipase Increased Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Company Tavor (Lorazepam) C Representative Indivina C Date:08/11/04ISR Number: 4426422-0Report Type:Expedited (15-DaCompany Report #DE_040713965 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bile Duct Stenosis Foreign Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Gastrooesophageal Reflux Professional (Olanzapine) PS 7.5 MG DAY Disease Other Lantus (Insulin Helicobacter Gastritis Glargine) C Hepatic Cyst Insulin, Regular C Hypoinsulinaemia Postoperative Jaundice Pancreatic Insufficiency Pancreaticoduodenectomy Transaminases Increased Date:08/11/04ISR Number: 4426429-3Report Type:Expedited (15-DaCompany Report #FR_040103431 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 40 MG/DAY Aminotransferase Other Largactil Increased (Chlorpromazine Blood Alkaline Hydrochloride) C Phosphatase Increased Rivotril Cholestasis (Clonazepam) C Fungal Infection Tercian Gamma-Glutamyltransferase (Cyamemazine) C Increased Teralithe (Lithium Prothrombin Time Carbonate) C Prolonged Date:08/11/04ISR Number: 4426515-8Report Type:Expedited (15-DaCompany Report #JP_040703721 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa-Oral Initial or Prolonged Syndrome Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Risperdal Representative (Risperidone) C Other Benzalin (Nitrazepam) C Gasmotin (Mosapride Citrate) C Gaster D 24-Jun-2005 12:19 PM Page: 3041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Famotidine) C Rohipnol (Flunitrazepam) C Tasmolin (Biperiden) C Horizon (Diazepam) C Date:08/11/04ISR Number: 4426623-1Report Type:Expedited (15-DaCompany Report #GBS030913675 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Drug Exposure During Literature (Olanzapine) PS Pregnancy Health Folic Acid C Intentional Self-Injury Professional Paracetamol Multiple Drug Overdose Other (Paracetamol) C Pregnancy Therapeutic Agent Toxicity Date:08/11/04ISR Number: 4426624-3Report Type:Expedited (15-DaCompany Report #JP_040703713 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG DAY Aminotransferase Company Flunitrazepam Increased Representative (Flunitrazepam) C Blood Bilirubin Increased Other Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Jaundice Upper Respiratory Tract Inflammation Viral Infection Date:08/11/04ISR Number: 4426625-5Report Type:Expedited (15-DaCompany Report #JP_040703723 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Flumezin Representative (Fluphenazine) C Other Contomin (Chlorpromazine Hydrochloride) C Lendormin (Brotizolam) C Rohipnol (Flunitrazepam) C 24-Jun-2005 12:19 PM Page: 3042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/04ISR Number: 4426704-2Report Type:Expedited (15-DaCompany Report #USA040773353 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Central Consumer Zyprexa Nervous System (Olanzapine) PS ORAL Weight Increased Depakote (Valproate Semisodium) C Tegretol (Carbamazepine) C Date:08/11/04ISR Number: 4426705-4Report Type:Expedited (15-DaCompany Report #USA040773377 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Consumer Zyprexa Initial or Prolonged Abnormal (Olanzapine) PS ORAL 20 MG DAY Other Blood Sodium Abnormal Klonopin Coma (Clonazepam) C Diabetes Insipidus Diabetes Mellitus Fall Pituitary Tumour Date:08/11/04ISR Number: 4426706-6Report Type:Expedited (15-DaCompany Report #USA040773445 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Disorder Consumer Zyprexa (Olanzapine) PS ORAL 50 MG DAY Seroquel (Quetiapine Fumurate) C Lorazepam C Date:08/11/04ISR Number: 4426707-8Report Type:Expedited (15-DaCompany Report #USA040773948 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urine Present Consumer Zyprexa Pancreatic Disorder (Olanzapine) PS ORAL Date:08/11/04ISR Number: 4426862-XReport Type:Expedited (15-DaCompany Report #FR_040704495 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Zyprexa-Oral Electrocardiogram Qt Health (Olanzapine) Corrected Interval Professional (Olanzapine) PS 20 MG DAY Prolonged Other Prozac-Oral Heart Rate Increased (Fluoxetine) Somnolence (Fluoxetine Ventricular Extrasystoles Hydrochloride) SS 20 MG/1 DAY Tercian (Cyamemazine) C Rivotril (Clonazepam) C 24-Jun-2005 12:19 PM Page: 3043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/04ISR Number: 4426863-1Report Type:Expedited (15-DaCompany Report #JP_040703982 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amino Acid Level Foreign Zyprexa-Oral Initial or Prolonged Decreased Health (Olanzapine) Other Circulatory Failure Professional (Olanzapine) PS Neonatal Company Drug Exposure During Representative Pregnancy Other Feeding Problem In Newborn Haematemesis Meconium Stain Neonatal Disorder Vomiting Neonatal Date:08/11/04ISR Number: 4426864-3Report Type:Expedited (15-DaCompany Report #DE_040714003 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Bone Pain Health (Olanzapine) Other C-Reactive Protein Professional (Olanzapine) PS 10 MG DAY Increased Other Fluctin-Oral Dizziness (Fluoxetine) Drug Toxicity (Fluoxetine Gastrointestinal Hydrochloride SS Haemorrhage Hypnorex - Slow Hypertension Release (Lithium Hypertonia Carbonate) C Hypotension Leukocytosis Meningism Photophobia Photosensitivity Reaction Self-Medication Tachycardia Treatment Noncompliance Visual Disturbance Vomiting Weight Fluctuation Date:08/11/04ISR Number: 4426866-7Report Type:Expedited (15-DaCompany Report #EWC040840120 Age:46 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Amylase Increased Cholelithiasis Dehydration Dialysis Haematocrit Decreased Hepatitis A Positive Leukopenia Psychomotor Agitation Renal Failure Acute Rhabdomyolysis Starvation White Blood Cell Count 24-Jun-2005 12:19 PM Page: 3044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 10 MG/2 DAY Professional Zyprexa-Rapid-Acting Company Im (Olanzapine) SS Representative Zyprexa-Dispersible Other (Olanzapine) (Olanzapine) SS 40 MG/1 DAY General Anaesthesia C Tavor (Lorazepam) C Tavor (Lorazepam) C Date:08/11/04ISR Number: 4426873-4Report Type:Expedited (15-DaCompany Report #CA_040707159 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heat Stroke Foreign Zyprexa Initial or Prolonged Health (Olanzapine) PS ORAL Professional Other Date:08/11/04ISR Number: 4426874-6Report Type:Expedited (15-DaCompany Report #EWC040740070 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniocentesis Abnormal Foreign Olanzapine-Oral Initial or Prolonged Blood Creatine Health (Olanzapine) PS Phosphokinase Increased Professional Depakine (Valproate Drug Exposure During Company Sodium) C Pregnancy Representative Hyperaesthesia Other Hypoglycaemia Neonatal Laboratory Test Abnormal Large For Dates Baby Neonatal Disorder Neonatal Pneumonia Tremor Neonatal Date:08/11/04ISR Number: 4426875-8Report Type:Expedited (15-DaCompany Report #FR_040704509 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa Initial or Prolonged Drug Abuser Health (Olanzapine PS Drug Toxicity Professional Havlane (Loprazolam Heart Rate Increased Other Mesilate) C Miosis Lexomil (Bromazepam) C Polysubstance Abuse Deroxat (Paroxetne Hydrochloride) C Equanil (Meprobamate) C 24-Jun-2005 12:19 PM Page: 3045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/04ISR Number: 4426876-XReport Type:Expedited (15-DaCompany Report #FR_040704508 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Foreign Zyprexa-Oral Initial or Prolonged Pyrexia Health (Olanzapine) Professional (Olanzapine) PS Other Akineton Retard (Biperiden Hydrochloride) C Tercian (Cyamemazine) C Date:08/11/04ISR Number: 4426877-1Report Type:Expedited (15-DaCompany Report #FR_040704500 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circadian Rhythm Sleep Foreign Zyprexa-Oral Initial or Prolonged Disorder Health (Olanzapine) Confusional State Professional (Olanzapine) PS 20 MG/1 DAY Disorientation Other Tercian Hallucination, Visual (Cyamemazine) C Hyperglycaemia Theralene Hypomania (Alimemazine Tartrate) C Date:08/11/04ISR Number: 4427331-3Report Type:Expedited (15-DaCompany Report #USA040773879 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Humalog-Human Npl Blood Cholesterol Insulin (Rdna) Increased (Lispro) PS Blood Glucose Increased Zyprexa-Oral Blood Triglycerides (Olanzapine) Increased (Olanzapine) SS 22.5 MG DAY Fatigue Humulin-Human Nph Feeling Abnormal Insulin (Rdna) Hallucination, Auditory (Human Insulin (Rd SS Hypoaesthesia Gemfibrozil C Malaise Niacin C Medication Error Nexium (Esomeprazole Pain In Extremity Magnesium) C Pancreas Infection Lipitor Pancreatitis (Atorvastatin) C Weight Decreased Date:08/12/04ISR Number: 4424149-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU01314 Age: Gender:Female I/FU:I Outcome PT Congenital Anomaly Cerebral Haemorrhage Other Neonatal Congenital Foot Malformation Convulsion Drug Exposure During Pregnancy Hepatosplenomegaly 24-Jun-2005 12:19 PM Page: 3046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neonatal Hyperammonaemia Hyperbilirubinaemia Hypoxia Report Source Product Role Manufacturer Route Dose Duration Liver Disorder Clozaril PS Novartis Sector: Neonatal Apnoeic Attack Pharma TRANSPLACENTAL Vomiting Epilim SS TRANSPLACENTAL Weight Decrease Neonatal Zyprexa SS TRANSPLACENTAL Zuclopenthixol Decanoate C TRANSPLACENTAL Date:08/12/04ISR Number: 4424407-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040706707 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Health Risperdal PS OROPHARINGEAL 48 MON Increased Professional Zyprexa SS OROPHARINGEAL 11 MON Blood Glucose Increased Sertraline C OROPHARINGEAL Blood Triglycerides Temazepam C dose taken at Increased night Polydipsia Clonazepam C dose taken at Polyuria night Trazodone C dose taken at night Date:08/12/04ISR Number: 4425305-XReport Type:Direct Company Report #CTU 224805 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Zyprexa 2.5 Mg PS ORAL PO QAM Hospitalization - Convulsion Initial or Prolonged Electromechanical Required Dissociation Intervention to Extubation Prevent Permanent Hypotension Impairment/Damage Mental Status Changes Neuroleptic Malignant Syndrome Resuscitation Salivary Hypersecretion Sinus Tachycardia Tremor Date:08/12/04ISR Number: 4444276-3Report Type:Periodic Company Report #USA020921349 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Consumer Humalog-. (Lispro) PS Initial or Prolonged Blood Glucose Increased Humulin-Human Nph Cerebrovascular Accident Insulin (Rdna) Fall (Human Insulin (Rd SS Hip Fracture Iletin-Beef/Pork Irritability Lente Insulin Triple Vessel Bypass (Insulin, Animal) SS 40 YR Graft Humulin-Human Lente Insulin (Rdna) (Human Insulin ( SS Zyprexa-Oral (Olanzapine) 24-Jun-2005 12:19 PM Page: 3047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS 10 MG/DAY Humulin-Human Regular Insulin (Rdna) (Human Insulin SS Lantus (Insulin Glargine) C Prevacid (Lansoprazole) C Ativan (Lorazepam) C Thyroid C Plavix (Clopidogrel Sulfate) C Date:08/16/04ISR Number: 4427370-2Report Type:Direct Company Report #CTU 224981 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stress Zyprexa PS SEE B5 IMAGE Weight Increased Diazepam C Percodan C Vicodin C Date:08/16/04ISR Number: 4427374-XReport Type:Direct Company Report #CTU 224968 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Olanzapine 50 Mg PS 50 MG ONCE Intervention to Non-Insulin-Dependent DAILY AT Prevent Permanent BEDTIME Impairment/Damage Date:08/17/04ISR Number: 4429917-9Report Type:Expedited (15-DaCompany Report #2004053261 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Zoloft (Sertraline) PS ORAL 50 MG (50 MG, Initial or Prolonged Metastases To Central 1 IN 1 D), Other Nervous System ORAL Post Procedural Nausea Olanzapine Pruritus (Olanzapine) SS ORAL 10 MG (10 MG, Treatment Noncompliance 1 IN 1 D), ORAL Antineoplastic Agents (Antineoplastic Agents) SS INTRAVENOUS INTRAVENOUS Allopurinol (Allopurinol) SS Date:08/17/04ISR Number: 4429976-3Report Type:Expedited (15-DaCompany Report #2004UW16769 Age:78 YR Gender:Male I/FU:I Outcome PT Hospitalization - Difficulty In Walking Initial or Prolonged Drug Effect Decreased Drug Withdrawal Syndrome Eating Disorder 24-Jun-2005 12:19 PM Page: 3048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinsonism Tremor Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Seroquel PS Haloperidol SS ORAL 1 MG PRN PO Haloperidol SS ORAL 1 MG TID PO Haloperidol SS ORAL 0.5 MG TID PO Zyprexa SS Lisinopril W/Hydrochlorothiazid e C Zestril C Date:08/17/04ISR Number: 4431078-7Report Type:Expedited (15-DaCompany Report #2004CG01605 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Mopral PS Increased Health Tercian SS Blood Potassium Increased Professional Kredex SS Diabetic Ketoacidosis Other Zyprexa SS ORAL 5 MG QD PO Hepatic Steatosis Triatec C Hypoalbuminaemia Femara C Hypoproteinaemia Hypovolaemic Shock Pancreatitis Acute Pancreatitis Necrotising Date:08/18/04ISR Number: 4428908-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-358869 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Rivotril PS Roche ORAL 10 DAY Initial or Prolonged Alanine Aminotransferase Zyprexa SS ORAL 11 DAY Increased Tercian SS ORAL 5 DAY Aspartate Largactil SS ORAL 7 DAY Aminotransferase Increased Blood Alkaline Phosphatase Increased Excitability Hepatitis Sleep Disorder Date:08/18/04ISR Number: 4429282-7Report Type:Direct Company Report #CTU 225226 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Olanzapine 20 Mg PS ORAL 20 MG HS ORAL Phosphokinase Increased Date:08/18/04ISR Number: 4430531-XReport Type:Expedited (15-DaCompany Report #FR_040804568 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Av Dissociation Initial or Prolonged Hypotension 24-Jun-2005 12:19 PM Page: 3049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Malaise Nodal Arrhythmia Report Source Product Role Manufacturer Route Dose Duration Renal Failure Foreign Zyprexa-Oral Sinus Bradycardia Health (Olanzapine) Tricuspid Valve Professional (Olanzapine) PS 10 MG/1 DAY Incompetence Other Zoplicone C Vertigo Diazepam C Vision Blurred Deroxat(Paroxetine Hydrochloride) C Date:08/18/04ISR Number: 4430532-1Report Type:Expedited (15-DaCompany Report #FR_040804569 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Foreign Zyprexa-Oral Hospitalization - Diabetes Mellitus Health (Olanzapine) Initial or Prolonged Insulin-Dependent Professional (Olanzapine) PS 10 MG/1 DAY Dyspnoea Other Hypokalaemia Hypophosphataemia Ketoacidosis Renal Failure Somnolence Date:08/18/04ISR Number: 4430533-3Report Type:Expedited (15-DaCompany Report #FR_040604260 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Zyprexa-Oral Initial or Prolonged Malaise Health (Olanzapine) Ventricular Extrasystoles Professional (Olanzapine) PS 7.5 MG DAY Other Date:08/18/04ISR Number: 4430541-2Report Type:Expedited (15-DaCompany Report #FR_040704539 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Henoch-Schonlein Purpura Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 5 MG/1 DAY Other Augmentin C Dafalgan (Paracetamol) C Oflocet (Ofloxacin) C Zyrtec (Cetirizine Hydrochloride) C Date:08/18/04ISR Number: 4430542-4Report Type:Expedited (15-DaCompany Report #GBS040815351 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Zyprexa-Oral Bundle Branch Block Left Health (Olanzapine) Sinus Bradycardia Professional (Olanzapine) PS 10 MG Other 24-Jun-2005 12:19 PM Page: 3050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/04ISR Number: 4430543-6Report Type:Expedited (15-DaCompany Report #JP_040804114 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Foreign Zyprexa-Oral Malaise Study (Olanzapine) Health (Olanzapine) PS 15 MG DAY Professional Haloperidol C Other Artane (Trihexyphenidyl Hydrochloride) C Date:08/18/04ISR Number: 4430581-3Report Type:Expedited (15-DaCompany Report #FR_040804566 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Zyprexa-Oral Hospitalization - Bundle Branch Block Health (Olanzapine) Initial or Prolonged Cerebral Haemorrhage Professional (Olanzapine) PS Cerebrovascular Accident Other Prazinil Intentional Misuse (Carpipramine Ischaemic Stroke Dihydrochloride) C Suicide Attempt Paroxetine C Thrombocytopenia Date:08/18/04ISR Number: 4431233-6Report Type:Expedited (15-DaCompany Report #US_0408104568 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Olanzapine-Oral Initial or Prolonged Consciousness Literature (Olanzapine) PS OTHER 75 MG OTHER Diabetes Insipidus Health Prazepam C Multiple Drug Overdose Professional Suicide Attempt Other Date:08/18/04ISR Number: 4431836-9Report Type:Expedited (15-DaCompany Report #US_0408104595 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Laboratory Test Abnormal Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:08/18/04ISR Number: 4431838-2Report Type:Expedited (15-DaCompany Report #US_0408104540 Age:39 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anion Gap Decreased Initial or Prolonged Anoxic Encephalopathy Other Aspiration Asthenia Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Glucose Increased Blood Sodium Increased Blood Urea Increased 24-Jun-2005 12:19 PM Page: 3051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bowel Sounds Abnormal Coma Dehydration Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Consumer Zyprexa-Oral Consciousness (Olanzapine) Diabetes Mellitus (Olanzapine) PS 15 MG/1 AT Non-Insulin-Dependent BEDTIME Diabetic Ketoacidosis Lithium C Difficult To Wean From Prilosec Ventilator (Omeprazole) C Disseminated Levothroid Intravascular Coagulation (Levothyroxine Dry Mouth Sodium) C Electroencephalogram Avapro (Irbesartan) C Abnormal Iron Supplement C Hypotension Paxil (Paroxetine Hypothyroidism Hydrochloride) C Hypovolaemia Lactic Acidosis Lethargy Malaise Metabolic Acidosis Muscle Enzyme Increased Muscle Injury Oedema Overdose Pco2 Decreased Platelet Count Decreased Pyrexia Sepsis Shock Sinus Tachycardia Sinusitis Therapeutic Agent Toxicity Thirst Date:08/18/04ISR Number: 4431842-4Report Type:Expedited (15-DaCompany Report #US_0408104538 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Other Zyprexa-Oral Initial or Prolonged Diabetic Gastroparesis (Olanzapine)(Olanzap ine) PS Fluvoxamine Maleate C Date:08/18/04ISR Number: 4431912-0Report Type:Expedited (15-DaCompany Report #USA040773982 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa-Oral Somnolence Professional (Olanzapine) (Olanzapine) PS 10 MG DAY Zyrtec (Cetirizine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/04ISR Number: 4431915-6Report Type:Expedited (15-DaCompany Report #USA040874155 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Zyprexa-Oral Abdominal Tenderness (Olanzapine) Blood Glucose Abnormal (Olanzapine) PS 20 MG Dizziness Albuterol C Epistaxis Gastric Disorder Hyperhidrosis Vomiting Date:08/18/04ISR Number: 4431917-XReport Type:Expedited (15-DaCompany Report #USA040874173 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Other Therapeutic Response Professional (Olanzapine) Decreased Company (Olanzapine) PS Representative Symbyax-Olanzapine /Fluoxetine (Unknown Dose) (Ola SS Date:08/18/04ISR Number: 4431977-6Report Type:Expedited (15-DaCompany Report #USA040874495 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Albuterol C Paxil (Paroxetine Hydrochloride) C Date:08/18/04ISR Number: 4431981-8Report Type:Expedited (15-DaCompany Report #USA040874652 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS 40 MG Date:08/18/04ISR Number: 4432158-2Report Type:Expedited (15-DaCompany Report #US_0408104622 Age:76 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Asterixis Other Clonus Confusion Postoperative Confusional State Delirium Depressed Level Of Consciousness Drug Interaction Echolalia Fall 24-Jun-2005 12:19 PM Page: 3053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Mania Perseveration Report Source Product Role Manufacturer Route Dose Duration Postoperative Infection Literature Olanzapine-Oral Sleep Attacks Health (Olanzapine) PS 30 MG DAY Sluggishness Professional Fluoxetine Somnolence Hydrochloride-Oral Spinal Operation (Fluoxetine) SS 20 MG DAY Staphylococcal Infection Valproate Sodium C Date:08/20/04ISR Number: 4430215-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040804627 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal Consta PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Olanzapine SS OROPHARINGEAL Lithium C OROPHARINGEAL Fluoxetine C OROPHARINGEAL Date:08/20/04ISR Number: 4432357-XReport Type:Expedited (15-DaCompany Report #EWC040840120 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa-Rapid-Acting Initial or Prolonged Cholelithiasis Health Im (Olanzapine) PS 10 MG/2 DAY Dialysis Professional Zyprexa-Rapid-Acting Hepatitis A Antibody Company Im (Olanzapine) SS Positive Representative Zyprexa-Dispensable Leukopenia Other (Olanzapine) Renal Failure Acute (Olanzapine) SS 40 MG/1 DAY Rhabdomyolysis General Anaesthesia C Transaminases Increased Tavor (Lorazepam) C Date:08/20/04ISR Number: 4432383-0Report Type:Expedited (15-DaCompany Report #DE_040713949 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa-Rapid-Acting Life-Threatening Cardiac Arrest Health Im(Olanzapine) PS 10 MG/1 DAY Hospitalization - Drug Interaction Professional Haldol-Janssen Initial or Prolonged Syncope Company Decanoat Ventricular Fibrillation Representative (Haloperidol Other Decanoate) C Tavor (Lorazepam) C Date:08/20/04ISR Number: 4432664-0Report Type:Expedited (15-DaCompany Report #USA040773134 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retinal Haemorrhage Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 10 MG/1 AT BEDTIME Lorazepam C Geodon (Ziprasidone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C Premarin C Prenatal Vitamins C Colace (Docusate Sodium) C Date:08/20/04ISR Number: 4432689-5Report Type:Expedited (15-DaCompany Report #US_030493865 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Consumer Zyprexa-Oral Increased Health (Olanzapine Drug Toxicity Professional (Olanzapine) PS 30 MG/DAY Fall Company Benadryl Hallucination, Auditory Representative (Diphenhydramine Liver Function Test Hydrochloride) C Abnormal Lamictal Overdose (Lamotrigine) C Skin Laceration Synthroid Tremor (Levothyroxine Sodium) C Avandia (Rosiglitazone Maleate) C Prevacid (Lansoprazole) C Atenolol C Claritin-D C Propanolol C Metformin C Loratadine C Lansoprazole C Simethicone C Cipro (Ciprofloxacin Hydrochloride) C Vicodin C Atenolol C Lescol (Fluvastatin Sodium) C Bactrim Ds C Colace (Docusate Sodium) C Toradol (Ketorolac Tromethamine) C Kefzol (Cefazolin Sodium) C Lipitor (Atorvastatin) C Risperdal (Risperidone) C Hydroxyzine Hydrochloride C Xenical (Orlistat) C Vanceril (Beclomethasone Dipropionate) C Albuterol C Melatonin C Haldol (Haloperidol Decanoate) C 24-Jun-2005 12:19 PM Page: 3055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/04ISR Number: 4432739-6Report Type:Expedited (15-DaCompany Report #EWC040639719 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Foreign Zyprexa-Oral Hospitalization - Dyspnoea Health (Olanzapine) Initial or Prolonged Tachycardia Professional (Olanzapine) PS 20 MG Disability Company Lithium C Other Representative Depakine (Valproate Other Sodium) C Cisordinol (Clopenthixol Hydrochloride) C Psychopax (Diazepam) C Parkemed (Mefenamic Acid) C Date:08/20/04ISR Number: 4432741-4Report Type:Expedited (15-DaCompany Report #JP_040102551 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Infarction Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Serenace Representative (Haloperidol) C Other Lithium Carbonate C Levomepromazine C Date:08/20/04ISR Number: 4432742-6Report Type:Expedited (15-DaCompany Report #JP_040703721 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Health (Olanzapine) Syndrome Professional (Olanzapine) PS 10 MG DAY Paralysis Company Risperdal Representative (Risperidone) C Other Benzalin (Nitrazepam) C Gasmotin (Mosapride Citrate) C Gaster D (Famotidine) C Rohipnol (Flunitrazepam) C Tasmolin (Biperiden) C Horizon (Diazepam) C Date:08/20/04ISR Number: 4432745-1Report Type:Expedited (15-DaCompany Report #DE_040714003 Age:49 YR Gender:Female I/FU:F Outcome PT Other Anaemia Bone Pain C-Reactive Protein Increased Dizziness Gastrointestinal 24-Jun-2005 12:19 PM Page: 3056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Hypertension Hypertonia Hypotension Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Foreign Zyprexa-Oral Meningism Consumer (Olanzapine) Photophobia Health (Olanzapine) PS 10 MG DAY Poisoning Professional Fluctin-Oral Tachycardia Other (Fluoxetine) Visual Disturbance (Fluoxetine Vomiting Hydrochloride SS Weight Increased Hypnorex - Slow Release (Lithium Carbonate) C Date:08/20/04ISR Number: 4432746-3Report Type:Expedited (15-DaCompany Report #GBS030913675 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Olanzapine-Oral Blood Alcohol Increased Literature (Olanzapine) PS Completed Suicide Consumer Folic Acid C Coronary Artery Health Co-Proxamol C Atherosclerosis Professional Epilim Chrono Depression Other (Valproate Sodium) C Drug Exposure During Pregnancy Drug Screen Positive Drug Toxicity Injury Asphyxiation Intentional Misuse Pregnancy Pulmonary Congestion Pulmonary Oedema Skin Laceration Sleep Disorder Vascular Injury Date:08/23/04ISR Number: 4433163-2Report Type:Expedited (15-DaCompany Report #2004054836 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Consumer Neurontin Condition Aggravated (Gabapentin) PS Fatigue Geodon (Ziprasidone Pain In Jaw Hydrochloride) Sexual Dysfunction (Ziprasidone) SS 40 MG Somnolence Risperidone Vision Blurred (Risperidone) SS Paracetamol (Paracetamol) SS Olanzapine (Olanzapine) SS Aripiprazole (Aripiprazole) SS 24-Jun-2005 12:19 PM Page: 3057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/04ISR Number: 4433813-0Report Type:Expedited (15-DaCompany Report #MK200408-0126-1 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Affective Disorder Foreign Anafranil Capsules Blood Calcium Decreased Other 100 PS 75MG, DAILY Blood Chloride Increased Zyprexa SS Blood Creatinine Teralithe SS Increased Nozinan SS Blood Sodium Increased Lepticur C Blood Urea Increased Cardiac Disorder General Physical Health Deterioration Heart Rate Increased Mitral Valve Prolapse Neuroleptic Malignant Syndrome Pericardial Effusion Pyrexia Respiratory Tract Congestion Sudden Death Torticollis Ventricular Arrhythmia Ventricular Hypertrophy Date:08/25/04ISR Number: 4433964-0Report Type:Expedited (15-DaCompany Report #US_0408104704 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Subarachnoid Haemorrhage Health Symbax-Olanzapine / Other Professional Fluoxetine (Ola PS Company Representative Date:08/25/04ISR Number: 4434006-3Report Type:Expedited (15-DaCompany Report #S04-USA-05507-01 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxic Encephalopathy Health Celexa (Citalopram Cardiac Arrest Professional Hydrobromide) PS ORAL 40 MG QD PO Coma Strattera SS 80 MG QD Mitral Valve Prolapse Zyprexa (Olanzapine) SS 2.5 MG QD Ventricular Fibrillation Mirapex C Date:08/25/04ISR Number: 4434023-3Report Type:Expedited (15-DaCompany Report #USA040874946 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 'Tranquilizer' C 24-Jun-2005 12:19 PM Page: 3058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/04ISR Number: 4434029-4Report Type:Expedited (15-DaCompany Report #EWC040539310 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Decreased Foreign Zyprexa-Dispersible Cerebrovascular Accident Health (Olanzapine) General Physical Health Professional (Olanzapine) PS 5 MG/2 DAY Deterioration Other Buronil (Melperone Hemiplegia Hydrochloride) C Hypertension Reminyl (Galantamine Visual Field Defect Hydrobromide) C Akineton (Biperiden Hydrochloride) C Date:08/25/04ISR Number: 4434033-6Report Type:Expedited (15-DaCompany Report #GBS040815351 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bundle Branch Block Left Foreign Zyprexa-Oral Electrocardiogram T Wave Health (Olanzapine) Abnormal Professional (Olanzapine) PS 10 MG DAY Sinus Arrhythmia Other Sinus Bradycardia Date:08/25/04ISR Number: 4434052-XReport Type:Expedited (15-DaCompany Report #US_0408104756 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Olanzapine-Oral Other Murder (Olanzapine) PS Date:08/25/04ISR Number: 4434054-3Report Type:Expedited (15-DaCompany Report #2004229040ES Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Trankimazin Drug Toxicity Study (Alprazolam) Tablet PS Other Citalopram (Citalopram) SS Olanzapine (Olanzapine) SS Alcohol C Date:08/25/04ISR Number: 4434056-7Report Type:Expedited (15-DaCompany Report #US_0408104738 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Consumer Zyprexa-Oral Initial or Prolonged Emotional Distress (Olanzapine) Feeling Jittery (Olanzapine) PS Hallucination, Auditory Haldol (Haloperidol Insomnia Decanoate) C Treatment Noncompliance Geodon (Ziprasidone Unevaluable Event Hydrochloride) C Weight Increased 24-Jun-2005 12:19 PM Page: 3059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/04ISR Number: 4434061-0Report Type:Expedited (15-DaCompany Report #USA040875224 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zyprexa-Oral Initial or Prolonged Aggression Professional (Olanzapine) PS 2.5 MG DAY 3 DAY Company Celexa (Citalopram Representative Hydrobromide) C Date:08/25/04ISR Number: 4434063-4Report Type:Expedited (15-DaCompany Report #USA040875114 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ill-Defined Disorder Consumer Zyprexa-Oral Initial or Prolonged Treatment Noncompliance (Olanzapine)(Olanzap Other Weight Increased ine) PS 20 MG DAY Lipitor (Atorvastatin) C Paxil (Paroxetine Hydrochloride) C Date:08/25/04ISR Number: 4434064-6Report Type:Expedited (15-DaCompany Report #USA040875123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Zyprexa-Oral Initial or Prolonged Mania Professional (Olanzapine)(Olanzap Oedema Peripheral Company ine) PS 15 MG DAY Treatment Noncompliance Representative Symbyax-Olanzapine / Fluoxetine (Unknown Dose) (Ola SS Date:08/25/04ISR Number: 4434067-1Report Type:Expedited (15-DaCompany Report #USA040875069 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa-Oral Initial or Prolonged Legal Problem Professional (Olanzaprine) Mania Company (Olanzaprine) PS Representative Symbyax-Olanzapine / Fluoxetine (Unknown Dose) (Ola SS Date:08/25/04ISR Number: 4434068-3Report Type:Expedited (15-DaCompany Report #USA040874778 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Consumer Zyprexa-Oral Initial or Prolonged Loss Of Consciousness (Olanzapine) Medication Error (Olanzapine) PS 20 MG DAY Paxil (Paroxetine Hydrochloride) C Namenda (Memantine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/04ISR Number: 4434186-XReport Type:Expedited (15-DaCompany Report #GBS030913675 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine Other Coronary Artery Literature (Olanzapine) PS ORAL Atherosclerosis Consumer Folic Acid C Depression Health Co-Proxamol C Drug Dependence Professional Epilim Chrono Drug Exposure During Other (Valproate Sodium) C Pregnancy Drug Toxicity Overdose Pharmaceutical Product Complaint Pregnancy Pulmonary Congestion Pulmonary Oedema Wound Date:08/25/04ISR Number: 4434215-3Report Type:Expedited (15-DaCompany Report #DE_040713949 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Zyprexa-Rapid-Acting Life-Threatening Cardiac Arrest Health Im (Olanzapine) PS 10 MG/L DAY Hospitalization - Drug Interaction Professional Haldol-Janssen Initial or Prolonged Syncope Company Decanoat Ventricular Fibrillation Representative (Haloperidol Other Decanoate) C Haldol "Janssen-Cilag" (Haloperidol) C Tavor (Lorazepam) C Date:08/25/04ISR Number: 4434218-9Report Type:Expedited (15-DaCompany Report #FR_040403857 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Failure Foreign Zyperxa-Rapid-Acting Initial or Prolonged Blood Calcium Decreased Health Im (Olanzapine) PS INTRAMUSCULAR 10 MG DAY Blood Creatinine Professional Zyprexa-Oral Decreased Company (Olanzapine) Blood Glucose Increased Representative (Olanzapine) SS ORAL 10 MG DAY Blood Lactate Other Deroxat (Paroxetine Dehydrogenase Increased Hydrochloride) C Blood Sodium Decreased Atarax (Hydroxyzine Intentional Misuse Hydrochloride) C Somnolence Tranxene Staphylococcal Sepsis (Clorazepate Dipotassium) C Stilnox (Zolpidem) C Date:08/25/04ISR Number: 4434271-2Report Type:Expedited (15-DaCompany Report #JP_040804114 Age:21 YR Gender:Female I/FU:I Outcome PT Other Delusion Malaise 24-Jun-2005 12:19 PM Page: 3061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Persecutory Delusion Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 15 MG DAY Professional Haloperidol C Other Artane (Trihexyphenidyl Hydrochloride) C Date:08/25/04ISR Number: 4434273-6Report Type:Expedited (15-DaCompany Report #FR_040804584 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS Myelocytosis Other Endoxan (Cyclophosphamide) C Tranxene (Clorazepate Dipotassium) C Paroxetine C Topalgic (Tramadol Hydrochloride) C Bactrim C Imovane (Zopiclone) C Fungizone (Amphotericin B) C Date:08/25/04ISR Number: 4434277-3Report Type:Expedited (15-DaCompany Report #DE_040814079 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Zyprexa-Oral Hospitalization - Chorea Health (Olanzapine) Initial or Prolonged Circulatory Collapse Professional (Olanzapine) PS 10 MG/2 DAY Cognitive Disorder Company Tavor (Lorazepam) C Psychotic Disorder Representative Levothyroxine C Tachyarrhythmia Other Treatment Noncompliance Date:08/25/04ISR Number: 4434387-0Report Type:Expedited (15-DaCompany Report #USA030536362 Age:81 YR Gender:Female I/FU:I Outcome PT Death Asthenia Hospitalization - Blood Potassium Increased Initial or Prolonged Cardiac Arrest Other Choking Difficulty In Walking Dizziness General Physical Health Deterioration Injection Site Erythema Injection Site Haemorrhage 24-Jun-2005 12:19 PM Page: 3062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication Error Movement Disorder Pain Report Source Product Role Manufacturer Route Dose Duration Consumer Forteo (Teriparatide) PS Zyprexa (Olanzapine) SS ORAL Altace (Ramipril) C Armour Thyroid (Thyroid) C Aricept (Donepezil Hydrochloride) C Caltrate + D C Centrum C Cortisone C Glucosamine W/Chondritin Sulfates C Lanoxin (Digoxin) C Lasix (Furosemide) C Micro-K (Potassium Chloride) C Trinalin C Verelan (Verapamil Hydrochloride) C Vicodin Es C Xanax (Alprazolam) C Zoloft (Sertraline Hydrochloride) C Date:08/25/04ISR Number: 4434417-6Report Type:Expedited (15-DaCompany Report #USA040567362 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Symbyax Other Accidental Death Professional Olanzapine 6mg / Alcohol Poisoning Company Fluoxetine 25mg PS Aortic Atherosclerosis Representative Depakote (Valproate Aspiration Semisodium) C Atelectasis Keppra Cardiomegaly (Levetiracetam) C Choking Klonopin(Clonazepam) C Convulsion Imitrex (Sumatriptan Haemorrhage Subcutaneous Succinate) C Hepatic Congestion Replax (Eletriptan Hepatic Steatosis Hydrobromide) C Meningeal Disorder Paxil (Paroxetine Pulmonary Congestion Hydrochloride) C Rib Fracture Self-Medication Toxicologic Test Abnormal Treatment Noncompliance Date:08/26/04ISR Number: 4435053-8Report Type:Direct Company Report #CTU 225721 Age:46 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Ineffective Initial or Prolonged Neuroleptic Malignant 24-Jun-2005 12:19 PM Page: 3063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Report Source Product Role Manufacturer Route Dose Duration Haloperidol PS 30 DAY Olanzapine SS 30 DAY Senna C Hctz C Synthroid C Nexium C Date:08/26/04ISR Number: 4435115-5Report Type:Direct Company Report #CTU 225710 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Zyprexa 10 Mg Lilly PS Lilly ORAL 10 MG Q DAILY Initial or Prolonged Dizziness ORAL Dyspnoea Date:08/30/04ISR Number: 4436780-9Report Type:Expedited (15-DaCompany Report #PHBS2004US11036 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acanthosis Nigricans Methylphenidate Blood Cholesterol Hydrochloride PS Novartis Sector: Increased Pharma UNKNOWN Diabetes Mellitus Clomipramine Hyperglycaemia Hydrochloride SS UNKNOWN Hypertriglyceridaemia Olanzapine SS UNKNOWN 10 mg/d 80640MIN Rash Papular Citalopram C UNKNOWN Xanthoma Trihexyphenidyl C UNKNOWN Buspirone C UNKNOWN Date:08/30/04ISR Number: 4437604-6Report Type:Direct Company Report #CTU 225904 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Zyprexia PS Initial or Prolonged Date:08/31/04ISR Number: 4439706-7Report Type:Expedited (15-DaCompany Report #2004PK01408 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Pseudophaeochromocytoma Health PO Prevent Permanent Tachycardia Professional Clopixol Impairment/Damage Other /00876701/ SS ORAL 125 MG DAILY PO Truxal SS ORAL 300 MG DAILY PO Zyprexa Velotab SS ORAL 10 MG DAILY PO Valium C Akineton C 24-Jun-2005 12:19 PM Page: 3064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4440562-1Report Type:Periodic Company Report #US_0405103066 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Prozac-Oral Initial or Prolonged Drug Withdrawal Syndrome Professional (Fluoxetine) Intentional Self-Injury Other (Fluoxetine Suicidal Ideation Hydrochloride) PS 20 MG/ 1 DAY Symbyax-Olanzapine 12mg / Fluoxetine 25mg (Olanzapi SS 22 DAY Lithium Carbonate C Furosemide C Kcl (Potassium Chloride) C Mvi (Mvi) C Date:08/31/04ISR Number: 4440571-2Report Type:Periodic Company Report #USA040670839 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Symbyax-Olanzapine Syncope Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Ambien (Zolpidem Tartrate) C Vitamins Nos C Calcium C Ogen (Estropipate) C Date:08/31/04ISR Number: 4440596-7Report Type:Periodic Company Report #USA040670760 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Balance Disorder (Olanzapine) Other Musculoskeletal Stiffness (Olanzapine) PS 20 MG/ 1 DAY Neuroleptic Malignant Symbyax-Olanzapine Syndrome 6mg / Fluoxetine 25mg (Olanzapin SS Depakote (Valproate Semisodium) C Dilantin (Phenytoin Sodium) C Date:08/31/04ISR Number: 4440602-XReport Type:Periodic Company Report #USA040670710 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Symbyax-Olanzapine 6 Professional Mg/ Fluoxetine 25 Mg Company (Olanzapine) PS Representative Adderall Xr C 24-Jun-2005 12:19 PM Page: 3065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4440606-7Report Type:Periodic Company Report #USA040670361 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cough Consumer Symbyax-Olanzapine 6 Lethargy Health Mg/ Fluoxetine 25 Mg Myocardial Infarction Professional (Olanzapine) PS Urinary Retention Clonopin (Clonazepam) C Zantac (Ranitidine Hydrochloride) C Vitamin B12 For Injection (Cyanocobalamin) C Iron C Date:08/31/04ISR Number: 4440611-0Report Type:Periodic Company Report #USA040567581 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Symbyax-Olanzapine 6 Initial or Prolonged Professional Mg/ Fluoxetine 25 Mg Other Company (Olanzapine) PS Representative Date:08/31/04ISR Number: 4440616-XReport Type:Periodic Company Report #USA040567539 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Symbyax-Olanzapine 6 Initial or Prolonged Professional Mg/ Fluoxetine 25 Mg Other (Olanzapine) PS 40 DAY Ambien (Zolpidem Tartrate) C Date:08/31/04ISR Number: 4440618-3Report Type:Periodic Company Report #USA040567498 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Symbyax-Olanzapine 6 Professional Mg/ Fluoxetine 25 Mg Company (Olanzapine) PS Representative Wellbutrin (Bupropion Hydrochloride) C Date:08/31/04ISR Number: 4440620-1Report Type:Periodic Company Report #USA040567023 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Symbyax-Olanzapine 6 Congestive Professional Mg/ Fluoxetine 25 Mg Company (Olanzapine) PS Representative Diovan Hct C Xanax (Alprazolam) C Inderal (Propranolol Hydrochloride) C Lipitor 24-Jun-2005 12:19 PM Page: 3066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) C Levoxyl (Levothyroxine Sodium) C Celexa (Citalopram Hydrobromide) C Date:08/31/04ISR Number: 4440643-2Report Type:Periodic Company Report #USA040465361 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Symbyax-Olanzapine 6 Initial or Prolonged Professional Mg/ Fluoxetine 25 Mg Company (Olanzapine) PS Representative Date:08/31/04ISR Number: 4441029-7Report Type:Periodic Company Report #USA040464362 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Symbyax-Olanzapine Convulsion Professional 6mg / Fluoxetine Dizziness 25mg (Olanzapin PS Feeling Hot Hyperhidrosis Date:08/31/04ISR Number: 4441030-3Report Type:Periodic Company Report #USA040463704 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Symbyax-Olanzapine / Initial or Prolonged Professional Fluoxetine (Ola PS Other Company Olanzapine-Oral(Olan Representative zapine) SS Date:08/31/04ISR Number: 4441031-5Report Type:Periodic Company Report #USA040363605 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Symbyax-Olanzapine Syndrome Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS 1 DSG FORM/1 Representative DAY Effexor-Xr (Venlafaxine Hydrochloride) C Date:08/31/04ISR Number: 4441032-7Report Type:Periodic Company Report #USA040362788 Age:20 YR Gender:Female I/FU:I Outcome PT Other Closed Head Injury Fall Hypoaesthesia Orthostatic Hypotension Skin Laceration Syncope 24-Jun-2005 12:19 PM Page: 3067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Symbyax-Olanzapine Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG/1 DAY Date:08/31/04ISR Number: 4441033-9Report Type:Periodic Company Report #USA040362367 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Symbyax-Olanzapine Professional 12mg / Fluoxetine Company 25mg (Olanzapi PS 1 DSG FORM/ 1 Representative DAY Ddavp (Desmopressin) C Date:08/31/04ISR Number: 4441034-0Report Type:Periodic Company Report #USA040360730 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compulsions Consumer Symbyax-Olanzapine Initial or Prolonged Drug Ineffective 6mg / Fluoxetine Feeling Abnormal 25mg (Olanzapin PS 1 DSG FORM / Pain In Extremity 2 DAY Skin Warm Chlorpromazine C Swelling Clonidine C Tremor Ritalin Urticaria (Methylphenidate Weight Increased Hydrochloride) C Clarinex (Desloratadine) C Date:09/01/04ISR Number: 4440449-4Report Type:Direct Company Report #CTU 226081 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Olanzapine PS ORAL 20 MG QD ORAL Abnormal Fluphenazine 5 Mg SS ORAL 5 MG AM HS ORAL Date:09/02/04ISR Number: 4439948-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040810137 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS OROPHARINGEAL Pericarditis Olanzapine SS OROPHARINGEAL Tachypnoea Clozapine SS OROPHARINGEAL Clozapine SS OROPHARINGEAL 24-Jun-2005 12:19 PM Page: 3068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/04ISR Number: 4444243-XReport Type:Expedited (15-DaCompany Report #USA040875426 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Consumer Prozac-Oral Initial or Prolonged (Fluoxetine) (Fluoxetine Hydrochloride) PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS Date:09/02/04ISR Number: 4444463-4Report Type:Expedited (15-DaCompany Report #USA030742499 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Drug Exposure During Professional (Olanzapine) Pregnancy (Olanzapine) PS 20MG/1 DAY Pregnancy Premature Labour Psychotic Disorder Treatment Noncompliance Date:09/02/04ISR Number: 4444465-8Report Type:Expedited (15-DaCompany Report #USA040875678 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis C Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG/ TWICE Representative A DAY Allegra (Fexofenadine Hydrochloride) C Date:09/02/04ISR Number: 4444466-XReport Type:Expedited (15-DaCompany Report #USA040875747 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immobile Consumer Zyprexa-Oral Thrombosis (Olanzapine) (Olanzapine) PS 2.5 MG DAY Risperdal (Risperidone) C Percocet C Xalatan (Latanoprost) C Cosopt C Date:09/02/04ISR Number: 4444467-1Report Type:Expedited (15-DaCompany Report #US_0408104858 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Zyprexa-Oral Initial or Prolonged Back Pain (Olanzapine) Dry Mouth (Olanzapine) PS Somnolence 24-Jun-2005 12:19 PM Page: 3069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/04ISR Number: 4444635-9Report Type:Expedited (15-DaCompany Report #US_0407104340 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Urea Decreased Consumer Zyprexa-Oral Cardiac Disorder (Olanzapine) Gastric Dilatation (Olanzapine) PS Hallucination Hypersomnia Insomnia Rectal Haemorrhage Treatment Noncompliance Date:09/02/04ISR Number: 4445876-7Report Type:Expedited (15-DaCompany Report #FR_040804584 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Condition Aggravated Other (Olanzapine) PS Myelocytosis Endoxan Neoplasm Malignant (Cyclophosphamide) C Tranxene (Clorazepate Dipotassium) C Paroxetine C Topalgic (Tramadol Hydrochloride) C Bactrim C Imovane (Zopiclone) C Fungizone (Amphotericin B) C Date:09/02/04ISR Number: 4446532-1Report Type:Expedited (15-DaCompany Report #EWC040840120 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Zyprexa-Rapid-Acting Initial or Prolonged Cholelithiasis Health Im (Olanzapine) PS 10 MG/2 DAY Dialysis Professional Zyprexa-Rapid-Acting Haematocrit Decreased Company Im (Olanzapine) SS Hepatitis A Positive Representative Zyprexa-Dispersible Leukopenia Other (Olanzapine) Renal Failure Acute (Olanzapine) SS 10 MG/2 DAY Rhabdomyolysis General Anaesthesia C Tavor (Lorazepam) C Tavor (Lorazepam) C Date:09/02/04ISR Number: 4446534-5Report Type:Expedited (15-DaCompany Report #EWC040639753 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Low Density Lipoprotein Foreign Zyprexa-Rapid-Acting Increased Health Im (Olanzapine) PS 10 MG Patient Restraint Professional Risperdal Consta Restlessness Company (Risperidone) C Sedation Representative Rivotril Sleep Apnoea Syndrome Other (Clonazepam) C Risperdal 24-Jun-2005 12:19 PM Page: 3070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) C Tranxilium (Clorazepate Dipotassium) C Depakine (Valproate Sodium) C Haloperidol C Date:09/02/04ISR Number: 4446536-9Report Type:Expedited (15-DaCompany Report #EWC040840330 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Olanzapine-Oral Initial or Prolonged Weight Increased Company (Olanzapine) PS Representative Lithium C Other Date:09/02/04ISR Number: 4446537-0Report Type:Expedited (15-DaCompany Report #EWC040740022 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anger Foreign Olanzapine-Oral Condition Aggravated Study (Olanzapine) PS 10 MG DAY Judgement Impaired Health Negativism Professional Psychotic Disorder Other Self-Injurious Ideation Suicidal Ideation Tension Date:09/02/04ISR Number: 4446539-4Report Type:Expedited (15-DaCompany Report #DE_040814112 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemolytic Anaemia Foreign Zyprexa-Oral Hospitalization - Immobile Health (Olanzapine) Initial or Prolonged Pneumonia Professional (Olanzapine) PS 20 MG DAY 3 YR Poor Venous Access Other Neurocil (Levomepromazine Maleate) C Remergil (Mirtazapine) C Date:09/02/04ISR Number: 4446542-4Report Type:Expedited (15-DaCompany Report #EWC040840286 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Olanzapine-Oral Initial or Prolonged Cytolytic Hepatitis Health (Olanzapine) PS 15 MG/1 DAY Professional Pirilene Other (Pyrazinamide) C Avalox (Moxifloxacin Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/04ISR Number: 4446549-7Report Type:Expedited (15-DaCompany Report #EWC040840341 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinsonism Foreign Zyprexa-Oral Hospitalization - Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG/DAY Other Furix (Furosemide) C Date:09/02/04ISR Number: 4446559-XReport Type:Expedited (15-DaCompany Report #CA_040807210 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Foreign Zyprexa-Rapid-Acting Initial or Prolonged Hyperammonaemia Health Im (Olanzapine) PS 5 MG/2 Professional Lorazepam C Company Metformin C Representative Glyburide C Other Date:09/02/04ISR Number: 4446854-4Report Type:Expedited (15-DaCompany Report #JP_040703713 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG DAY Aminotransferase Company Flunitrazepam Increased Representative (Flunitrazepam) C Blood Bilirubin Increased Other Condition Aggravated Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Jaundice Upper Respiratory Tract Inflammation Viral Infection Date:09/02/04ISR Number: 4446858-1Report Type:Expedited (15-DaCompany Report #DE_040613851 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Damage Foreign Zyprexa-Oral Initial or Prolonged Fall Health (Olanzapine) Pleurothotonus Professional (Olanzapine) PS 5 MG IN THE Therapeutic Agent Other EVENING Toxicity Reboxetine C Dominal Forte (Prothipendyl Hydrochloride) C Sotalol C Enalapril C Dipiperon C Calcium C Vigantoletten (Colecalciferol) C Kalinor (Potassium Chloride) C 24-Jun-2005 12:19 PM Page: 3072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetylsalicylic Acid C Bifiteral (Lactulose) C Date:09/02/04ISR Number: 4446859-3Report Type:Expedited (15-DaCompany Report #DE_040814079 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Zyprexa-Oral Hospitalization - Chorea Health (Olanzapine) Initial or Prolonged Circulatory Collapse Professional (Olanzapine) PS 10 MG/2 DAY Cognitive Disorder Company Tavor (Lorazepam) C Psychotic Disorder Representative Levothyroxine C Tachyarrhythmia Other Treatment Noncompliance Date:09/02/04ISR Number: 4446860-XReport Type:Expedited (15-DaCompany Report #DE_040213027 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Anaemia Professional (Olanzapine) PS 5 MG DAY Aspartate Company Multibionta C Aminotransferase Representative Clexane Increased Other (Heparin-Fraction, Blood Creatine Sodium Salt) C Phosphokinase Increased Fortimel C Blood Lactate Dehydrogenase Increased Leukopenia Neutropenia Platelet Count Decreased Thrombocythaemia Date:09/03/04ISR Number: 4440511-6Report Type:Expedited (15-DaCompany Report #PHBS2004US11398 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Health Baclofen PS Novartis Sector: Consciousness Professional Pharma UNKNOWN Dizziness Tizanidine Tachycardia Hydrochloride SS UNKNOWN Nortriptyline Hydrochloride SS UNKNOWN Gabapentin SS UNKNOWN Phenelzine SS UNKNOWN Ketorolac SS UNKNOWN Bethanechol SS UNKNOWN Olanzapine SS UNKNOWN Date:09/03/04ISR Number: 4441659-2Report Type:Expedited (15-DaCompany Report #2004-DE-04435GD Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Foreign Codeine (Codeine) PS Literature Olanzapine 24-Jun-2005 12:19 PM Page: 3073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS Venlafaxine (Venlafaxine) SS Flurazepam (Flurazepam) SS Metoclopramide (Metoclopramide) SS Date:09/03/04ISR Number: 4441662-2Report Type:Expedited (15-DaCompany Report #2004-DE-04432GD Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Codeine(Codeine) PS Literature Olanzapine (Olanzapine) SS Paracetamol C Date:09/03/04ISR Number: 4441672-5Report Type:Expedited (15-DaCompany Report #2004-DE-04436GD Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Codeine (Codeine) PS Toxicologic Test Abnormal Literature Olanzapine (Olanzapine) SS Phenytoin (Phenytoin) SS Oxycodone (Oxycodone) SS Alprazolam (Alprazolam) SS Citalopram (Citalopram) SS Date:09/03/04ISR Number: 4441714-7Report Type:Expedited (15-DaCompany Report #2004S1002504 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Consumer Zonegran Elan PS ORAL 200MG Q AM Initial or Prolonged Below Therapeutic AND 300MG Q Other Grand Mal Convulsion HS, ORAL Phenytek Capsules 300mg Mylan Bertek (A Subsidiary Of Mylan Laboratories) SS ORAL 300MG BID THEN 300MG QD AND 300 MG QOD, ORAL Phenytek Capsules 200 Mg Mylan Bertek (A Subsidiary Of Mylan Laboratories) SS ORAL 200MG Q AM AND 400MG QOD, ORAL Zyprexa Lilly SS ORAL ORAL Escitalopram C Lorazepam (Prn) C Diazepam (Pm) C Donepezil C Clorazepate C 24-Jun-2005 12:19 PM Page: 3074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/04ISR Number: 4443486-9Report Type:Direct Company Report #CTU 226315 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Olanzepine 10 Mg PS ORAL 10 MG BID Initial or Prolonged Fall ORAL Fatigue Bupropion C Hyperosmolar State Omeprazole C Urine Output Increased Diltiazem C Weight Decreased Chlordiazepoxide C Hydrochlorothiazide C Date:09/03/04ISR Number: 4444657-8Report Type:Expedited (15-DaCompany Report #2004-DE-04438GD Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Foreign Lorazepam Accidental Overdose Literature (Lorazepam) PS Olanzapine (Olanzapine) SS Date:09/03/04ISR Number: 4445302-8Report Type:Expedited (15-DaCompany Report #DSA_24857_2004 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Foreign Wypax PS Pregnancy Health Zyprexa SS Neonatal Apnoeic Attack Professional Zyprexa C Other Date:09/07/04ISR Number: 4444972-8Report Type:Direct Company Report #CTU 226488 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemic Olanzapine 30 Mg Po Initial or Prolonged Hyperosmolar Nonketotic Qhs PS ORAL ABOVE (30 MG Syndrome PO QHS) 26 DAY Pancreatic Mass Divalproate C Asa C Detrol C Atenolol C Nexium C Pancrealipase C Flomax C Date:09/07/04ISR Number: 4445644-6Report Type:Expedited (15-DaCompany Report #2004PK01437 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Beloc-Zok PS ORAL 200 MG QD PO Initial or Prolonged Anticholinergic Syndrome Health Seroquel SS ORAL 50 MG DAILY Confusional State Professional PO Drug Interaction Other Deroxat SS ORAL 30 MG DAILY Drug Level Increased PO Mydriasis Zyprexa SS ORAL 10 MG DAILY Tachycardia PO Temesta SS ORAL 2.5 MG DAILY PO 24-Jun-2005 12:19 PM Page: 3075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eltroxin "Glaxo" C Torem C Co-Diovan C Selipran C Aldactone C Marcoumar C Date:09/07/04ISR Number: 4455138-XReport Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0344069A Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Deroxat PS Glaxosmithkline ORAL 30MG Per day 7 MON Initial or Prolonged Anticholinergic Syndrome Beloc Zok SS ORAL 200MG Per day 9 MON Confusional State Zyprexa SS ORAL 10MG Per day 9 MON Disorientation Temesta SS ORAL 2.5MG Per day 9 MON Drug Interaction Seroquel SS ORAL 50MG Per day Mydriasis Eltroxin C Glaxosmithkline ORAL .01MG Per day MON Perseveration Torem C ORAL 10MG Per day MON Tachycardia Co-Diovan C ORAL MON Selipran C ORAL 40MG Per day MON Aldactone C ORAL 25MG Per day Marcoumar C ORAL MON Date:09/08/04ISR Number: 4446669-7Report Type:Expedited (15-DaCompany Report #DE_040714003 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged C-Reactive Protein Consumer (Olanzapine) Other Increased Health (Olanzapine) PS 10 MG DAY Dizziness Professional Fluctin-Oral Drug Level Below Other (Fluoxetine) Therapeutic (Fluoxetine Drug Toxicity Hydrochloride) SS Gastrointestinal Hypnorex (Litium Haemorrhage Carbonate) C Headache Hypertension Hypertensive Crisis Hypertonia Hypotension Leukocytosis Mania Meningism Oral Intake Reduced Pain Photophobia Refusal Of Treatment By Patient Spinal Disorder Tachycardia Treatment Noncompliance Visual Disturbance Vomiting Weight Decreased Weight Increased 24-Jun-2005 12:19 PM Page: 3076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/04ISR Number: 4446714-9Report Type:Expedited (15-DaCompany Report #2004IC000854 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Dalmadorm "Icn" Initial or Prolonged Consciousness Health (Flurazepam Respiratory Failure Professional Hydrochloride) (30 Sleep Apnoea Syndrome Mg) PS ORAL 30 MG;DAILY;ORAL Seroquel (Quetiapine Fumarate) SS ORAL 200 MG;X1;ORAL Zyprexa (Olanzapine)(10 Mg) SS ORAL 10MG;DAILY;OR AL Temesta (Lorazepam) (2.5mg) SS ORAL 2.5MG; 3 TIMES A DAY; ORAL Lithiofor C Depakine Chrono C Akineton C Date:09/09/04ISR Number: 4447922-3Report Type:Direct Company Report #CTU 226740 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Zyprexa 7.5mg Eli Skin Striae Lily PS Eli Lilly ORAL 7.5MG 1XDAY Weight Increased ORAL Effexor Xr C Date:09/09/04ISR Number: 4448553-1Report Type:Expedited (15-DaCompany Report #GBS040815454 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Olanzapine-Oral Ejection Fraction Health (Olanzapine) PS 6 YR Decreased Professional Exercise Tolerance Other Decreased Date:09/09/04ISR Number: 4448554-3Report Type:Expedited (15-DaCompany Report #GBS040815351 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bundle Branch Block Left Foreign Zyprexa-Oral Other Electrocardiogram T Wave Health (Olanzapine) Abnormal Professional (Olanzapine) PS 10 MG DAY Psychological Factor Other Risperidone C Affecting Medical Procyclidine C Condition Sinus Arrhythmia Sinus Bradycardia 24-Jun-2005 12:19 PM Page: 3077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4448556-7Report Type:Expedited (15-DaCompany Report #EWC040840365 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haematemesis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 150 MG/1 Other Date:09/09/04ISR Number: 4448557-9Report Type:Expedited (15-DaCompany Report #EWC040840351 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Chorioretinopathy Foreign Zyprexa-Oral Vision Blurred Health (Olanzapine) Visual Acuity Reduced Professional (Olanzapine) PS 15 MG/1 DAY Other Solian (Amisulpride) C Flupentixol C Tafil (Alprazolam Dum) C Date:09/09/04ISR Number: 4448558-0Report Type:Expedited (15-DaCompany Report #GBS040815452 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congestive Cardiomyopathy Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Other Date:09/09/04ISR Number: 4448576-2Report Type:Expedited (15-DaCompany Report #JP_040703982 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Zyprexa Oral Initial or Prolonged Drug Exposure During Health (Olanzapine)(Olanzap Pregnancy Professional ine) PS Drug Withdrawal Syndrome Company Neonatal Representative Haematemesis Other Meconium Stain Neonatal Disorder Date:09/09/04ISR Number: 4448577-4Report Type:Expedited (15-DaCompany Report #JP_030400671 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compulsions Foreign Olanzapine-Oral Initial or Prolonged Constipation Study (Olanzapine) PS 10 MG/1 DAY Delusion Health Zotepine C Hallucination Professional Biperiden C Hyperlipidaemia Other Flunitrazepam C Rash Brotizolam C Urinary Retention Timiperone C Alprazolam C Chlorpromazine C 24-Jun-2005 12:19 PM Page: 3078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4448578-6Report Type:Expedited (15-DaCompany Report #FR_040804643 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Rapid-Acting Initial or Prolonged Phosphokinase Increased Health Im (Olanzapine) PS 10 MG DAY Body Temperature Professional Zyprexa-Oral Increased Other (Olanzapine) (Olanzapine) SS 15 MG DAY Date:09/09/04ISR Number: 4448581-6Report Type:Expedited (15-DaCompany Report #EWC040438731 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Pacemaker Foreign Zyprexa-Rapid-Acting Hospitalization - Insertion Health Im (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Drug Ineffective Professional Dehydrobenzperidol Unevaluable Event Company (Droperidol) C Representative Other Date:09/09/04ISR Number: 4448582-8Report Type:Expedited (15-DaCompany Report #AU_040507697 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colour Blindness Foreign Zyprexa-Oral Diverticulitis Health (Olanzapine) Nerve Conduction Studies Professional (Olanzapine) PS 10 MG/1 DAY 6 YR Abnormal Other Optic Neuropathy Vision Blurred Visual Acuity Reduced Visual Field Defect Date:09/09/04ISR Number: 4448591-9Report Type:Expedited (15-DaCompany Report #EWC040840341 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinsonism Foreign Zyprexa-Oral Hospitalization - Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG/DAY Other Furix (Furosemide) C Date:09/09/04ISR Number: 4448610-XReport Type:Expedited (15-DaCompany Report #JP_040603281 Age:44 YR Gender:Male I/FU:F Outcome PT Life-Threatening Blood Chloride Decreased Hospitalization - Chemical Abuser Initial or Prolonged Condition Aggravated Convulsion Depressed Level Of Consciousness Haemodialysis Hepatic Function Abnormal Hepatitis B Hyponatraemia Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 3079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Water Intoxication Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa Oral Health (Olanzapine)(Olanzap Professional ine) PS 5 MG DAY Company Meilax(Ethyl Representative Loflazepate) C Other Benzalin(Nitrazepam) C Date:09/09/04ISR Number: 4448613-5Report Type:Expedited (15-DaCompany Report #JP_040503182 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Zyprexa Oral Initial or Prolonged Fall Study (Olanzapine)(Olanzap Other Femoral Neck Fracture Health ine) PS 5 MG DAY Gastritis Erosive Professional Halosten(Haloperidol Nausea Other ) C Oral Intake Reduced Vegetamin B C Persecutory Delusion Doral(Quazepam) C Vomiting Seroquel(Qquetiapine Fumarate) C Date:09/09/04ISR Number: 4448621-4Report Type:Expedited (15-DaCompany Report #EWC040438828 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Zyprexa-Oral Initial or Prolonged Coma Health (Olanzapine) Disability Heart Rate Decreased Professional (Olanzapine) PS 15 MG/1 DAY Multiple Drug Overdose Other Methadone C Parkinsonian Crisis Suicide Attempt Date:09/09/04ISR Number: 4448624-XReport Type:Expedited (15-DaCompany Report #DE_040613816 Age:61 YR Gender:Male I/FU:F Outcome PT Life-Threatening Aggression Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Arrhythmia Aspartate Aminotransferase Increased Blood Pressure Increased Cardiac Arrest Cardiomyopathy Circulatory Collapse Dyspnoea Gamma-Glutamyltransferase Increased Loss Of Consciousness Normochromic Normocytic Anaemia Reflexes Abnormal Syncope Vasovagal 24-Jun-2005 12:19 PM Page: 3080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Extrasystoles Ventricular Fibrillation Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Other Levomepromazine C Haloperidol C Biperiden C Diazepam C Date:09/09/04ISR Number: 4448658-5Report Type:Expedited (15-DaCompany Report #DSA_24879_2004 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Foreign Tavor PS ORAL 8 MG ONCE PO Initial or Prolonged Eyelid Ptosis Health Zyprexa SS ORAL 35 MG ONCE PO Intentional Misuse Professional Somnolence Other Tachycardia Date:09/09/04ISR Number: 4448934-6Report Type:Expedited (15-DaCompany Report #USA040876437 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Gun Shot Wound Professional (Olanzapine) Head Injury Company (Olanzapine) PS Representative Date:09/09/04ISR Number: 4448935-8Report Type:Expedited (15-DaCompany Report #USA040876166 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa-Oral Dry Mouth Professional (Olanzapine) Electrocardiogram Qt Company (Olanzapine) PS 600 MG DAY Prolonged Representative Navane (Tiotixine) C Hallucination, Auditory Benadryl Overdose (Diphenhydramine Restlessness Hydrochloride) C Somnolence Suicide Attempt Date:09/09/04ISR Number: 4448937-1Report Type:Expedited (15-DaCompany Report #USA040876181 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa-Oral Initial or Prolonged Drug Interaction Professional (Olanzapine) Dysarthria Company (Olanzapine) PS 5 MG/1 DAY Pyrexia Representative Lithium C Paxil (Paroxetine Hydrochloride) C Dexedrine (Dexamfetamine Sulfate) C 24-Jun-2005 12:19 PM Page: 3081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4448940-1Report Type:Expedited (15-DaCompany Report #US_0408105026 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Zyprexa-Oral Affective Disorder (Olanzapine) Aggression (Olanzapine) PS 15 MG Anxiety Clonazepam C Attention Deficit/Hyperactivity Disorder Convulsion Depressed Level Of Consciousness Disease Recurrence Drug Abuser Fatigue Headache Hypersomnia Hypoglycaemia Hypomania Impaired Healing Irritability Learning Disorder Mental Disorder Mood Altered Musculoskeletal Stiffness Nausea Nervous System Disorder Personality Disorder Polyuria Psychiatric Symptom Self-Injurious Ideation Self-Medication Skin Ulcer Sleep Disorder Social Avoidant Behaviour Stress Tachypnoea Thirst Vomiting Date:09/09/04ISR Number: 4448943-7Report Type:Expedited (15-DaCompany Report #US_0408104904 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Acrochordon Consumer Zyprexa-Oral Drug Exposure During (Olanzapine) Pregnancy (Olanzapine) PS Premature Baby Prenatal Vitamins C Date:09/09/04ISR Number: 4448944-9Report Type:Expedited (15-DaCompany Report #USA040876553 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphonia Consumer Zyprexa-Oral Initial or Prolonged Fall Other (Olanzapine) Disability Memory Impairment (Olanzapine) PS 20 MG/AT Other Myocardial Infarction NIGHT Upper Limb Fracture Proazc-Oral 24-Jun-2005 12:19 PM Page: 3082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Fluoxetine) (Fluoxetine Hydrochloride) C Lexapro (Escitalopram Oxalate) C Lisinopril (Lisinopril) C Depakote (Valproate Semisodium) C Date:09/09/04ISR Number: 4448946-2Report Type:Expedited (15-DaCompany Report #USA040876499 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Cognitive Disorder (Olanzapine) Condition Aggravated (Olanzapine) PS Pressure Of Speech Depakote (Valproate Semisodium) C Albilify (Aripiprazole) C Date:09/09/04ISR Number: 4448964-4Report Type:Expedited (15-DaCompany Report #USA040361307 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa Initial or Prolonged Abnormal Behaviour Health Zydis-Dispersible Aggression Professional (Olanzapine) Agitation (Olanzapine) PS 5 MG/1 AT Attention BEDTIME Deficit/Hyperactivity Strattera Disorder (Atomoxetine Haematemesis Hydrochloride) SS 40 MG/1 DAY Hallucination, Visual Depakote (Valproate Headache Semisodium) C Hunger Celexa (Citalopram Psychomotor Hyperactivity Hydrobromide) C Self Injurious Behaviour Ritalin Stomach Discomfort (Methylphenidate Weight Increased Hydrochloride) C Trileptal (Oxcarbazepine) C Ranitidine C Clonidine C Date:09/09/04ISR Number: 4449074-2Report Type:Expedited (15-DaCompany Report #USA040566479 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Strattera(Atomoxetin Life-Threatening Anoxic Encephalopathy Professional e Hydrochloride) PS 80 MG/ 1 DAY Hospitalization - Anxiety Company Zyprexa-Oral Initial or Prolonged Brain Death Representative (Olanzapine) Cardiac Arrest (Olanzapine) SS 2.5 MG DAY Loss Of Consciousness Celexa (Citalopram Hydrobromide) C Mirapex (Mirapex) C 24-Jun-2005 12:19 PM Page: 3083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4449236-4Report Type:Expedited (15-DaCompany Report #USA040876108 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Zyprexa-Oral Hospitalization - Malaise (Olanzapine)(Olanzap Initial or Prolonged Nausea ine) PS 2.5 MG DAY Metoprolol C Coumadin (Warfarin Sodium) C Aricept (Donepezil Hydrochloride) C Date:09/09/04ISR Number: 4449239-XReport Type:Expedited (15-DaCompany Report #USA040876078 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine)(Olanzap Other Nausea ine) PS 15 MG/1 DAY Weight Decreased Ativan (Lorazepam) C Weight Increased Date:09/09/04ISR Number: 4449241-8Report Type:Expedited (15-DaCompany Report #USA040875932 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Zyprexa-Oral Dizziness (Olanzapine) Loss Of Consciousness (Olanzapine) PS 5 YR Date:09/09/04ISR Number: 4449458-2Report Type:Expedited (15-DaCompany Report #US_0408104704 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Subarachnoid Haemorrhage Health Symbyax-Olanzapine / Other Professional Fluoxetine (Unknown Company Dose) (Ola PS Representative Date:09/10/04ISR Number: 4449138-3Report Type:Expedited (15-DaCompany Report #2004PK01482 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Consciousness Health PO Gaze Palsy Professional Zyprexa SS ORAL 10 MG DAILY Pupil Fixed Other PO Respiratory Failure Dalmadorm SS ORAL 30 MG DAILY PO Temesta SS ORAL 2.5 MG TID PO Lithiofor C Depakene Chrono C Akineton C 24-Jun-2005 12:19 PM Page: 3084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/04ISR Number: 4449488-0Report Type:Direct Company Report #CTU 226806 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Zyprexa 10 Mg Hospitalization - Sepsis Lilly PS Lilly BUCCAL 10 MG QHS Initial or Prolonged BUCCAL Required Zyprexa SS Lilly BUCCAL 5 Q6HP Intervention to BUCCAL Prevent Permanent Impairment/Damage Date:09/13/04ISR Number: 4449430-2Report Type:Expedited (15-DaCompany Report #S04-GER-03184-01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Cipramil (Citalopram Initial or Prolonged Somnolence Health Hydrobromide) PS ORAL 60 MG QD PO Status Epilepticus Professional Zyprexa (Olanzapine) SS ORAL 10 MG QD PO Suicide Attempt Other Trimipramine SS Tavor (Lorazepam) C Date:09/14/04ISR Number: 4449454-5Report Type:Expedited (15-DaCompany Report #04P-056-0271841-00 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Depakote (Divalproex Initial or Prolonged Neuroleptic Malignant Health Sodium) (Divalproex Syndrome Professional Sodium) PS ORAL 500 MG, 1 IN Urinary Tract Infection 1 D, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 D, PER ORAL Prazepam C Levothyroxine Sodium C Estradiol C Promegestone C Date:09/14/04ISR Number: 4450353-3Report Type:Expedited (15-DaCompany Report #2004CG01605 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Potassium Increased Foreign Mopral PS Diabetic Ketoacidosis Health Tercian SS Hepatic Steatosis Professional Kredex SS Hypoalbuminaemia Other Zyprexa SS Hypoproteinaemia Triatec C Hypovolaemic Shock Femara C Pancreatitis Necrotising Date:09/14/04ISR Number: 4450562-3Report Type:Expedited (15-DaCompany Report #2004047917 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Bowel Sounds Abnormal Health MG, 2 IN 1 Diarrhoea Professional D), ORAL Schizophrenia Zoloft (Sertraline) SS ORAL 150 MG (1 IN 1 D), ORAL 24-Jun-2005 12:19 PM Page: 3085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine (Olanzapine) SS Quetiapine Fumarate (Quetiapine Fumarate) C Esomeprazole (Esomeprazole) C Date:09/15/04ISR Number: 4450049-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12692117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify Tabs 10 Mg PS Otsuka Drug Withdrawal Syndrome Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Muscle Strain Zyprexa SS ORAL Nausea Fluctine C ORAL Date:09/15/04ISR Number: 4452020-9Report Type:Direct Company Report #CTU 227234 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Communication Disorder Cogentin PS 0.5 MG BID Hospitalization - Hyperglycaemia Zyprexa SS 7.5 MG QHS Initial or Prolonged Lethargy Nitrobid C Mental Status Changes Lithium C Renal Failure Chronic Amantadine C Proscar C Flomax C Prevacid C Cardizem Cd C Cardura C Date:09/15/04ISR Number: 4452056-8Report Type:Direct Company Report #CTU 227258 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Hypoxia Zyprexa - Lilly PS Lilly Coma Tracheostomy Date:09/16/04ISR Number: 4451392-9Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040706707 Age: Gender:Female I/FU:I Outcome PT Death Blood Cholesterol Increased Blood Glucose Increased Blood Triglycerides Increased Cholecystitis Cholelithiasis Obstructive Circulatory Collapse Cough Diabetic Ketoacidosis Hepatic Steatosis 24-Jun-2005 12:19 PM Page: 3086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypothyroidism Pancreatitis Acute Polydipsia Report Source Product Role Manufacturer Route Dose Duration Polyuria Health Risperdal PS OROPHARINGEAL 48 MON Pulmonary Oedema Professional Zyprexa SS OROPHARINGEAL 11 MON Reflux Oesophagitis Sertraline C OROPHARINGEAL Thyroid Atrophy Temazepam C dose taken at night Clonazepam C dose taken at night Trazodone C dose taken at night Date:09/17/04ISR Number: 4455041-5Report Type:Expedited (15-DaCompany Report #USA040568683 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Activities Of Daily Health (Olanzapine) Disability Living Impaired Professional (Olanzapine) PS 7.5 MG DAY Amnesia Celexa (Citalopram Anorexia Hydrobromide) C Anxiety Xanax (Alprazolam Back Pain Dum) C Dental Operation Darvocet-N C Drug Abuser Versed (Midazolam Dysgraphia Hydrochloride) C Impaired Work Ability Alprazolam C Insomnia Medication Error Migraine Neck Pain Pain In Extremity Road Traffic Accident Self-Medication Suicidal Ideation Weight Increased Date:09/17/04ISR Number: 4455043-9Report Type:Expedited (15-DaCompany Report #USA040670957 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Zyprexa-Oral Fall Professional (Olanzapine) Head Injury Company (Olanzapine) PS 20 MG Representative Date:09/17/04ISR Number: 4455044-0Report Type:Expedited (15-DaCompany Report #USA040874495 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Hospitalization - Multiple Drug Overdose Professional (Olanzapine) Initial or Prolonged Respiration Abnormal Company (Olanzapine) PS 20 MG/1 IN Suicide Attempt Representative THE EVENING Albuterol C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/04ISR Number: 4455288-8Report Type:Expedited (15-DaCompany Report #EWC040639616 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Rapid-Acting Initial or Prolonged Neuroleptic Malignant Health Im (Olanzapine) PS 1 DSG FORM/2 Other Syndrome Professional DAY Pneumonia Aspiration Company Seropram (Citalopram Representative Hydrochloride) C Other Seduxen (Diazepam) C Date:09/17/04ISR Number: 4455462-0Report Type:Expedited (15-DaCompany Report #JP_040904367 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Aggression Study (Olanzapine) Excitability Health (Olanzapine) PS 10 MG DAY Haemorrhage Professional Haloperidol C Refusal Of Treatment By Other Levomepromazine C Patient Akineton (Biperiden Scratch Lactate) C Self Mutilation Bibittoace (Flunitrazepam) C Alosenn C Sennoside A C Date:09/17/04ISR Number: 4455469-3Report Type:Expedited (15-DaCompany Report #AU_040808012 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dystonia Foreign Zyprexa-Oral Hospitalization - Obstructive Airways Health (Olanzapine) Initial or Prolonged Disorder Professional (Olanzapine) PS 10 MG Company Anti-Hypertensive C Representative Other Date:09/17/04ISR Number: 4455478-4Report Type:Expedited (15-DaCompany Report #EWC040940470 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Disorder Foreign Olanzapine-Rapid-Act Atherosclerosis Health ing Im PS 20 MG DAY Hypertonia Professional Cardura (Doxazosin) C Ischaemic Cardiomyopathy Other Clopixol Depot Pulmonary Embolism (Zuclopenthixol Sudden Death Decanoate) C Tisercin (Levomepromazine) C Date:09/17/04ISR Number: 4455539-XReport Type:Expedited (15-DaCompany Report #DE_040713949 Age:43 YR Gender:Female I/FU:F Outcome Death Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 3088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Foreign Zyprexa-Rapid-Acting Cardiac Arrest Health Im (Olanzapine) PS 10 MG/1 DAY Syncope Professional Haldol-Janssen Ventricular Fibrillation Company Decanoat Representative (Haloperidol Other Decanoate) C Haldol "Janssen-Cilag" (Haloperidol) C Tavor (Lorazepam) C Haldol(Halopeidol) C Date:09/17/04ISR Number: 4455540-6Report Type:Expedited (15-DaCompany Report #CA_040807210 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa-Rapid-Acting Initial or Prolonged Blood Pressure Systolic Health Im (Olanzapine) PS 5 MG/2 Increased Professional Lorazepam C Coma Company Metformin C Hyperammonaemia Representative Glyburide C Other Date:09/17/04ISR Number: 4455678-3Report Type:Expedited (15-DaCompany Report #USA040876940 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Health Zyprexa-Oral Initial or Prolonged Cholecystitis Professional (Olanzapine ) Other Confusional State (Olanzapine) PS 10 MG IN THE Dehydration EVENING Drooling Lithium C Epistaxis Coumadin (Warfarin Fall Sodium) C General Physical Health Deterioration Hip Fracture Laboratory Test Abnormal Lip Disorder Muscle Rigidity Pancreatitis Pneumonia Renal Function Test Abnormal Somnolence Tremor White Blood Cell Count Increased Date:09/17/04ISR Number: 4455681-3Report Type:Expedited (15-DaCompany Report #USA040260105 Age:64 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cough Initial or Prolonged Escherichia Urinary Tract 24-Jun-2005 12:19 PM Page: 3089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Hallucination Lung Infiltration Memory Impairment Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa- Oral Syndrome Professional (Olanzapine)(Olanzap Respiratory Alkalosis ine) PS Prozac-Oral (Floxetine) (Fluoxetine Hydrochloride) SS 20 MG DAY Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Lortab C Quinine C Nystatin C Diflucan (Fluconazole C Lithium C Depakote (Valproate Semisodium) C Metformin C Demadex (Torasemide) C Glyburide C Syntrhoid (Levothyroxine Sodium) C Restoril (Temazepam) C Date:09/17/04ISR Number: 4455713-2Report Type:Expedited (15-DaCompany Report #USA040876608 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Health Symbax-Olanzapine Professional 6mg / Fluoxetine Company 25mg(Olanzapin PS 2 WK Representative Date:09/17/04ISR Number: 4455714-4Report Type:Expedited (15-DaCompany Report #USA040977121 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Symbyax-Olanzapine Initial or Prolonged Delusion Professional 6mg/Fluoxetine 25 Mg Eye Burns Company (Olanzapin PS Hypotension Representative Overdose Psychotic Disorder Self-Medication Date:09/17/04ISR Number: 4455741-7Report Type:Expedited (15-DaCompany Report #US_0408105111 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa -Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/04ISR Number: 4455742-9Report Type:Expedited (15-DaCompany Report #USA040977233 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Loss Of Consciousness (Olanzapine) Other Prescribed Overdose (Olanzapine) PS 15 MG Sleep Walking Zyprexa-Dispersible (Olanzapine) (Olanzapine) SS 30 MG Abilify (Aripiprazole) C Depakote (Valproate Semisodium) C Date:09/17/04ISR Number: 4455799-5Report Type:Expedited (15-DaCompany Report #DE_040914229 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Psychosis Foreign Zyprexa-Oral Hospitalization - Disease Recurrence Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 2.5 MG/2 DAY Other Levodopa C Date:09/17/04ISR Number: 4455800-9Report Type:Expedited (15-DaCompany Report #CA_040607043 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphagia Foreign Zyprexa-Oral Hospitalization - Cerebrovascular Accident Consumer (Olanzapine) Initial or Prolonged Coma Other (Olanzapine) PS 7.5 MG/2 DAY Other Dehydration Coumadin (Warfarin Dysarthria Sodum) C Dysphagia Fall Hyperaesthesia Hypersomnia Monoplegia Muscle Atrophy Weight Decreased Date:09/17/04ISR Number: 4455803-4Report Type:Expedited (15-DaCompany Report #FR_040904668 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Hepatitis B Health (Olanzapine) Leukopenia Professional (Olanzapine) PS 20 MG DAY Lymphoma Other Date:09/17/04ISR Number: 4455804-6Report Type:Expedited (15-DaCompany Report #DE_040814216 Age:84 YR Gender:Female I/FU:I Outcome PT Hospitalization - Antibody Test Positive Initial or Prolonged Autoimmune Hepatitis Other Dementia Nervous System Disorder 24-Jun-2005 12:19 PM Page: 3091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Systemic Lupus Erythematosus Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2L5 MG DAY Other Candesartan Cilexetil W/Hydrochlorothiazid e C Ass (Acetylsalicylic Acid) C Dipiperon/Gfr/(Pipam perone) C Date:09/17/04ISR Number: 4455806-XReport Type:Expedited (15-DaCompany Report #EWC040840381 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metrorrhagia Foreign Olanzapine-Oral Initial or Prolonged Pelvic Inflammatory Health (Olanzapine) PS 10 MG/DAY Disease Professional Olanzapine C Other Date:09/17/04ISR Number: 4455808-3Report Type:Expedited (15-DaCompany Report #EWS040940457 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anticonvulsant Drug Level Foreign Zyprexa-Oral Increased Health (Olanzapine) Drug Level Increased Professional (Olanzapine) PS Other Carbamazepine (Carbamazepine) C Fluoxetine (Fluoxetine) C Levomepromazine C Date:09/17/04ISR Number: 4455810-1Report Type:Expedited (15-DaCompany Report #EWC040840411 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Olzanzapine-Oral Initial or Prolonged Anticholinergic Syndrome Health (Olzanapine) PS 10 MG DAY 9 MON Antidepressant Drug Level Professional Deroxat (Paroxetine Increased Other Hydrochloride) C Confusional State Beloc Zok Mydriasis (Metorpolol Tachycardia Succinate) C Temesta (Lorazepam) C Seroquel (Quetiapine Fumarate) C Eltroxin (Levothyroxine Sodium) C Torem (Torasemide Sodium) C Co-Diovan C Selipran 24-Jun-2005 12:19 PM Page: 3092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pravastatin Sodium) C Aldactone (Spironolactone) C Marcoumar (Phenprocoumon) C Date:09/17/04ISR Number: 4456279-3Report Type:Expedited (15-DaCompany Report #USA040566479 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Strattera Life-Threatening Anoxic Encephalopathy Professional (Atomoxetine Hospitalization - Anxiety Company Hydrochloride) PS 80 MG/1 DAY Initial or Prolonged Brain Death Representative Zyprexa-Oral Cardiac Arrest (Olanzapine) (Olanzapine) SS 2.5 MG DAY Celexa (Citalopram Hydrobromide) C Mirapex (Mirapex) C Date:09/17/04ISR Number: 4456370-1Report Type:Expedited (15-DaCompany Report #DSA_24962_2004 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Temesta PS ORAL 2.5 MG Q DAY Initial or Prolonged Anticholinergic Syndrome Health PO Confusional State Professional Beloc Zok SS ORAL 200 MG QD PO Drug Interaction Other Deroxat SS ORAL 30 MG QD PO Drug Level Increased Deroxat SS ORAL 5 MG QD PO Mydriasis Seroquel SS ORAL 50 MG QD PO Tachycardia Zyprexa SS ORAL 10 MG QD PO Zyprexa SS ORAL 2.5 MG QD PO Eltroxin C Torem C Co-Diovan C Selipran C Aldactone C Marcoumar C Date:09/20/04ISR Number: 4453441-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040706707 Age: Gender:Female I/FU:I Outcome PT Death Blood Cholesterol Increased Blood Glucose Increased Blood Triglycerides Increased Cholecystitis Chronic Cholelithiasis Obstructive Diabetic Ketoacidosis Hepatic Steatosis Hypothyroidism Pancreatitis Acute Polydipsia Polyuria Pulmonary Congestion Reflux Oesophagitis 24-Jun-2005 12:19 PM Page: 3093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroid Atrophy Report Source Product Role Manufacturer Route Dose Duration Health Risperdal PS OROPHARINGEAL 48 MON Professional Zyprexa SS OROPHARINGEAL 11 MON Sertraline C OROPHARINGEAL Temazepam C dose taken at night Clonazepam C dose taken at night Trazodone C dose taken at night Date:09/20/04ISR Number: 4454728-8Report Type:Direct Company Report #CTU 227587 E Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Olanzapine 10mg PS ORAL 10 MG QHS Initial or Prolonged Respiratory Failure ORAL Date:09/21/04ISR Number: 4456558-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903566 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Tylenol Regular Hospitalization - Cardiac Arrest Health Strength Initial or Prolonged Electrocardiogram Qrs Professional (Acetaminophen) PS ORAL 975 MG, 1 IN Other Complex Prolonged 1 DAY, ORAL General Physical Health Olanzapine Deterioration (Olanzapine) SS ORAL 465 MG, 1 IN Multiple Drug Overdose 1 DAY, ORAL Oxygen Saturation Decreased Sinus Tachycardia Suicide Attempt Vomiting Date:09/21/04ISR Number: 4457040-6Report Type:Expedited (15-DaCompany Report #S04-GER-03184-01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Cipramil Initial or Prolonged Overdose Health (Citalopram Somnolence Professional Hydrobromide) PS ORAL 60 MG QD PO Status Epilepticus Other Zyprexa (Olanzapine) SS ORAL 10 MG QD PO Suicide Attempt Trimipramine SS Tavor (Lorazepam) C Date:09/21/04ISR Number: 4457066-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903625 Age:58 YR Gender:Female I/FU:I Outcome PT Death Acidosis Hospitalization - Acute Respiratory Initial or Prolonged Distress Syndrome Other Alanine Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 3094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Calcium Decreased Literature Acetaminophen Cardiac Arrest Health (Acetaminophen) PS ORAL ORAL Coagulopathy Professional Olanzapine Coma (Olanzapine) SS ORAL ORAL Compartment Syndrome Buspirone Exposure To Toxic Agent (Buspirone) SS ORAL ORAL Haemodialysis Paroxetine Labile Blood Pressure (Paroxetine) SS ORAL ORAL Renal Failure Gabapentin Toxicologic Test Abnormal (Gabapentin) SS ORAL ORAL Levothyroxine (Levothyroxine) SS ORAL ORAL Estrogens (Estrogens) SS ORAL ORAL Medication (All Other Therapeutic Products) SS ORAL ORAL Date:09/22/04ISR Number: 4455985-4Report Type:Expedited (15-DaCompany Report #379428 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Consumer Kredex PS Glaxosmithkline Abdominal Pain Upper Zyprexa SS ORAL 5MG Per day Blood Glucose Increased Mopral SS ORAL Diabetes Mellitus Tercian SS ORAL Hepatic Steatosis Femara C Hypoalbuminaemia Triatec C Hypovolaemic Shock Inflammation Ketoacidosis Pancreatitis Necrotising Date:09/22/04ISR Number: 4457165-5Report Type:Expedited (15-DaCompany Report #USA040361626 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Increased Consumer Forteo(Teriparatide) PS Initial or Prolonged Bone Density Decreased Zyprexa-Oral Other Hip Arthroplasty (Olanzapine) Knee Arthroplasty (Olanzapine) SS 5MG Skin Disorder Lactulose C Spinal Fusion Acquired Celebrex (Celecoxib) C Folic Acid C Lisinoprill C Hydrochlorothiazide C Synthroid( Levothyroxine Sodium) C Ditropan (Oxybutynin) C Xanax (Alprazolam) C Milk Of Magnesia C Coumadin (Warfarin Sodium) C Remeron 24-Jun-2005 12:19 PM Page: 3095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mirtazapine) C Effexor (Venlafaxine Hydrochloride) C Allopurinol C Date:09/22/04ISR Number: 4457385-XReport Type:Expedited (15-DaCompany Report #USA040977678 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Health Symbyax-Olanzapine Other Cardio-Respiratory Arrest Professional 6mg / Fluoxetine Condition Aggravated Company 50mg (Olanzapin PS Depression Representative Hydrocodone C Overdose Morphine C Tonsillectomy Date:09/22/04ISR Number: 4457398-8Report Type:Expedited (15-DaCompany Report #US_0406103781 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Study Olanzapine-Oral Halitosis Health (Olanzapine) PS 15 MG AT Refusal Of Treatment By Professional BEDTIME Patient Lantus (Insulinglargine) C Novolog (Insulin Aspart) C Glucovance C Lotrel C Lipitor (Atorvastatin) C Date:09/22/04ISR Number: 4457402-7Report Type:Expedited (15-DaCompany Report #USA040669705 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Health Strattera Initial or Prolonged Blood Potassium Decreased Professional (Atomoxetine Other Cerebral Atrophy Hydrochloride) PS Disease Recurrence Zyprexa Electroencephalogram (Olanzapine) SS ORAL Abnormal Lexapro Foreign Body Trauma (Escitalopram) C Haematocrit Decreased Dilantin (Phenytoin Haemoglobin Decreased Sodium) C Neuroleptic Malignant Coumadin (Warfarin Syndrome Sodium) C Platelet Count Increased Tylenol Pleural Effusion (Paracetamol) C Pneumonia Aspiration Metoprolol C Post Procedural Memantine Complication Hydrochloride C Rhabdomyolysis Reminyl (Galantamine Serotonin Syndrome Hydrobromide) C Sputum Culture Positive Trileptal Staphylococcal Infection (Oxcarbazepine) C Bromocryptine Mesylate C Dantrolene C 24-Jun-2005 12:19 PM Page: 3096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levaquin (Levofloxacin) C Date:09/22/04ISR Number: 4457403-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903624 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Literature Acetaminophen Hospitalization - Increased Health (Acetaminophen) PS ORAL ORAL Initial or Prolonged Aspartate Professional Olanzapine Other Aminotransferase (Olanzapine) SS ORAL ORAL Increased Trazodone Bilirubin Conjugated (Trazodone) C Increased Topiramate Blood Bilirubin Increased (Topiramate) C Brain Herniation Valproic Acid Coma (Valrpoic Acid) C Dialysis Electrocardiogram Qt Corrected Interval Prolonged Haemorrhage Intracranial International Normalised Ratio Increased Vomiting Date:09/22/04ISR Number: 4457443-XReport Type:Expedited (15-DaCompany Report #USA030536362 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activities Of Daily Consumer Forteo Hospitalization - Living Impaired Health (Teriparatide) PS 20 UG DAY Initial or Prolonged Asthenia Professional Zyprexa-Oral Other Blood Potassium Increased (Olanzapine) Cardiac Arrest (Olanzapine) SS Cardiac Failure Altace (Ramipril) C Congestive Armour Thyroid Condition Aggravated (Thyroid) C Cyanosis Aricept (Donepezil Difficulty In Walking Hydrochloride) C Dizziness Caltrate + D C General Physical Health Centrum C Deterioration Cortisone C Hyperkalaemia Glucosamine Hypokinesia W/Chondroitin Ill-Defined Disorder Sulfates C Injection Site Erythema Lanoxin(Digoxin) C Injection Site Lasix(Furosemide) C Haemorrhage Micro-K(Potassium Medication Error Chloride) C Overdose Trinalin C Pain Verelan(Verapamil Pneumothorax Hydrochloride) C Post Procedural Vicodin Es C Complication Xanax(Alprazolam) C Vascular Insufficiency Zoloft(Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/04ISR Number: 4457513-6Report Type:Expedited (15-DaCompany Report #USA040977625 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:09/22/04ISR Number: 4457517-3Report Type:Expedited (15-DaCompany Report #USA040977764 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa-Oral Initial or Prolonged Blood Sodium Decreased (Olanzapine) Chest Discomfort (Olanzapine) PS 20 MG IN THE Diabetes Mellitus EVENING Gastrointestinal Disorder Effexor (Venlafaxine Hepatic Enzyme Increased Hydrochloride) C Colace (Docusate Sodium) C Clonazepam C Tramadol (Tramadol) C Ambien (Zolpidem Tartrate) C Carbamazepine (Carbamazepine) C Vicodin Es C Acidbutal Caps (Apap/Butal/Caff 325-50-40) C Naproxen (Naproxen Sodium) C Baclofen C Albuterol C Prevacid (Lansoprazole) C Date:09/22/04ISR Number: 4457519-7Report Type:Expedited (15-DaCompany Report #USA040977537 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Consumer Zyprexa-Oral Drug Level Increased Company (Olanzapine) Representative (Olanzapine) PS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Date:09/22/04ISR Number: 4457524-0Report Type:Expedited (15-DaCompany Report #US_0409105278 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Consumer Zyprexa-Oral Initial or Prolonged Pregnancy (Olanzapine) Neonatal Aspiration (Olanzapine) PS Prozac-Oral (Fluoxetine) 24-Jun-2005 12:19 PM Page: 3098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Fluoxetine Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Prenatal Vitamins C Anafranil (Clomipramine Hydrochloride) C Date:09/22/04ISR Number: 4457560-4Report Type:Expedited (15-DaCompany Report #USA040977662 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 15 MG/ 1 DAY Representative Depakote (Valproate Semisodium0 C Date:09/22/04ISR Number: 4457620-8Report Type:Expedited (15-DaCompany Report #HQWYE984810SEP04 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Self-Injury Health Efexor (Venlafaxine Laceration Professional Hydrochloride, Other Tablet) PS Zyprexa (Olanzapine, ) SS Date:09/22/04ISR Number: 4457633-6Report Type:Expedited (15-DaCompany Report #US_010770104 Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Asthma Other Benign Neoplasm Of Thyroid Gland Blood Glucose Increased Confusional State Depression Diarrhoea Fear Hair Texture Abnormal Hallucination Headache Hypothyroidism Injection Site Discomfort Insomnia Insulin Resistance Iodine Allergy Lower Limb Fracture Mental Disorder Nausea Nightmare Pain Palpitations Pernicious Anaemia Pharmaceutical Product 24-Jun-2005 12:19 PM Page: 3099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Complaint Pharyngolaryngeal Pain Pyrexia Road Traffic Accident Report Source Product Role Manufacturer Route Dose Duration Skin Ulcer Consumer Humulin-Human Nph Speech Disorder Insulin (Rdna) Stomach Discomfort (Human Insulin (Rd PS 80 U/DAY Thinking Abnormal Prozac-Oral Throat Irritation (Fluoxetine) Vomiting (Fluoxetine Weight Decreased Hydrochloride) SS 20 MG Zyprexa-Oral (Olanzapine) (Olanzapine) SS Phentermine C Pondimin (Fenfluramine Hydrochloride) C Levothyroxine C Armour Thyroid (Thyroid) C Glucophage (Metformin Hydrochloride) C Avandia (Rosiglitazone Hydrochloride) C Vitamins C Magnesium C Chromium C Redux (Dexfenfluramine Hydrochloride) C Novolin (Insulin Human Injection, Isophane) C Seroquel (Quetiapine Fumarate) C Prozac (Fluoxetine Hydrochloride) C Tryptophan, L- C Date:09/22/04ISR Number: 4458046-3Report Type:Expedited (15-DaCompany Report #EWC040940513 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Foreign Zyprexa-Oral Initial or Prolonged Alcohol Use Other (Olanzapine) Fatigue (Olanzapine) PS 500 MG Feeling Abnormal Clomipramine C Heart Rate Increased Intentional Misuse Miosis Suicide Attempt 24-Jun-2005 12:19 PM Page: 3100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/04ISR Number: 4458048-7Report Type:Expedited (15-DaCompany Report #EWC040940538 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa Initial or Prolonged Confusional State Consumer Velotab-Dispersible Dyspnoea Company (Olanzapine) Eczema Representative (Olanzapin PS 15 MG DAY Hyperhidrosis Other En (Delorazepam) C Logorrhoea Paranoia Swelling Face Weight Increased Date:09/22/04ISR Number: 4458050-5Report Type:Expedited (15-DaCompany Report #CA_040506988 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Aggression Health (Olanzapine) Agitation Professional (Olanzapine) PS 5 MG IN THE Crying Company EVENING Delusion Representative Celexa (Citalopram Depressed Mood Other Hydrobromide) C Depression Risperidone C Haematocrit Decreased Zoloft (Sertraline Haemoglobin Decreased Hydrochloride) C Inappropriate Affect Incoherent Irritability Mean Cell Haemoglobin Concentration Decreased Paranoia Physical Assault Pregnancy Red Cell Distribution Width Increased Schizoaffective Disorder Screaming Thinking Abnormal Treatment Noncompliance Date:09/22/04ISR Number: 4458055-4Report Type:Expedited (15-DaCompany Report #DE_040914256 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Foreign Zyprexa-Oral Hepatic Cirrhosis Health (Olanzapine) Hepatic Failure Professional (Olanzapine) PS Hepatitis C Other Pregnancy Date:09/22/04ISR Number: 4458058-XReport Type:Expedited (15-DaCompany Report #EWC040940457 Age:35 YR Gender:Male I/FU:F Outcome PT Death Aspiration Cerebral Atrophy Cerebral Disorder 24-Jun-2005 12:19 PM Page: 3101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cerebral Haemorrhage Drug Screen Positive Epilepsy Report Source Product Role Manufacturer Route Dose Duration Scar Foreign Zyprexa-Oral Therapeutic Agent Health (Olanzapine) Toxicity Professional (Olanzapine) PS 10 MG DAY Other Carbamazepine (Carbamazepine) C Fluoxetine (Fluoxetine) C Levopromazine C Date:09/22/04ISR Number: 4458063-3Report Type:Expedited (15-DaCompany Report #CA_040807210 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ornithine Foreign Zyprexa-Rapid-Acting Initial or Prolonged Transcarbamoylase Health Im(Olanzapine) PS 5 MG/2 Deficiency Professional Lorazepam C Company Metformin C Representative Glyburide C Other Date:09/22/04ISR Number: 4458065-7Report Type:Expedited (15-DaCompany Report #EWC040639616 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Rapid-Acting Initial or Prolonged Extrapyramidal Disorder Health Im (Olanzapine) PS 1 DSG FORM/2 Other Neuroleptic Malignant Professional DAY Syndrome Company Seropram (Citalopram Pneumonia Aspiration Representative Hydrrobromide) C Schizophrenia, Catatonic Other Seduxen (Diazepam) C Type Date:09/22/04ISR Number: 4458188-2Report Type:Expedited (15-DaCompany Report #FR_040904674 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa-Oral Convulsion Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Other Prazinil (Carpipramine Dihydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Date:09/22/04ISR Number: 4458190-0Report Type:Expedited (15-DaCompany Report #GBS040915525 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Polymyositis Foreign Olanzapine-Oral Hospitalization - Renal Failure Health (Olanzapine) PS UNKNOWN UNK Initial or Prolonged Professional Tamsulosin C Other Diazepam C 24-Jun-2005 12:19 PM Page: 3102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C Amitriptyline C Frusemide C Date:09/22/04ISR Number: 4458201-2Report Type:Expedited (15-DaCompany Report #GBS040915533 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Olanzapine-Oral Myocardial Ischaemia Health (Olanzapine) PS 10 MG Professional Venlafaxine C Other Date:09/22/04ISR Number: 4458203-6Report Type:Expedited (15-DaCompany Report #EWC040940479 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Olanzapine-Oral Initial or Prolonged Consciousness Health (Olanzapine) PS 10 MG/1 DAY Drug Level Increased Professional Seroquel (Quetiapine Pupillary Reflex Impaired Other Fumarate) C Respiratory Failure Dalmadorm (Flurazepam Hydrochloride) C Temesta (Lorazepam) C Lithium C Valproate Sodium C Akineton (Biperiden Lactate) C Date:09/22/04ISR Number: 4458376-5Report Type:Expedited (15-DaCompany Report #US_0409105286 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zyprexa-Rapid-Acting Infarction Health Im (Olanzapine) PS 20 MG/1 Blood Glucose Increased Professional Haloperidol C Somnolence Company Haloperidol C Representative Levomepromazine C Other Diazepam C Carbamazepine (Carbamazepine) C Date:09/22/04ISR Number: 4458377-7Report Type:Expedited (15-DaCompany Report #EWC040940574 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Foreign Zyprexa-Rapid-Acting Study Im (Olanzapine) PS 10 MG/1 Health Professional Other 24-Jun-2005 12:19 PM Page: 3103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/04ISR Number: 4458378-9Report Type:Expedited (15-DaCompany Report #JP_040904382 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Foreign Zyprexa-Oral Hormone Decreased Health (Olanzapine) Professional (Olazapine) PS 5 MG DAY Company Depas9etizolam) C Representative Rohypnol(Flunitrazep Other am) C Date:09/22/04ISR Number: 4458420-5Report Type:Expedited (15-DaCompany Report #AU_040908034 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa-Oral Hepatic Steatosis Health (Olanzapine) Liver Disorder Professional (Olanzapine) PS 10 MG/1 DAY Company Risperidone C Representative Other Date:09/22/04ISR Number: 4458421-7Report Type:Expedited (15-DaCompany Report #JP_040904431 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine)(Olanzap Professional ine) PS 15 MG DAY Company Representative Other Date:09/23/04ISR Number: 4458400-XReport Type:Expedited (15-DaCompany Report #JP_040904442 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Abnormal Sleep-Related Health (Olanzapine) Event Professional (Olanzapine) PS 5 MG DAY Soliloquy Company Risperdal Representative (Risperidone) C Other Akineton (Biperiden Lactate) C Lendormin (Brotizolam) C Date:09/23/04ISR Number: 4459690-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903507 Age:32 YR Gender:Male I/FU:I Outcome PT Death Anion Gap Increased Hospitalization - Blood Bicarbonate Initial or Prolonged Decreased Other Blood Ethanol Increased Blood Ph Decreased Completed Suicide Drug Ineffective 24-Jun-2005 12:19 PM Page: 3104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Haemodialysis Mental Impairment Report Source Product Role Manufacturer Route Dose Duration Pco2 Decreased Literature Acetaminophen Pneumonia Aspiration Health (Acetaminophen) PS ORAL ORAL Po2 Decreased Professional Aspirin Sinus Tachycardia (Acetylsalicylic Tachypnoea Acid) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Pioglitazone (Pioglitazone) SS ORAL ORAL Simvastatin (Simvastatin) SS ORAL ORAL Date:09/23/04ISR Number: 4461209-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903683 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Literature Extra Strength Hospitalization - Anion Gap Increased Health Tylenol Initial or Prolonged Blood Bicarbonate Professional (Acetaminophen) PS ORAL ORAL Other Decreased Citalopram Blood Glucose Decreased (Citalopram) SS ORAL ORAL Blood Ph Decreased Clonazepam Coma (Clonazepam) SS ORAL ORAL Meningitis Buspirone Paralysis (Buspirone) SS ORAL ORAL Pco2 Decreased Fexofenadine Pco2 Increased (Fexofenadine) SS ORAL ORAL Sepsis Gabapentin Toxicologic Test Abnormal (Gabapentin) SS ORAL ORAL Transaminases Increased Dicylcomine/Phenobar White Blood Cell Count bital (Merbentyl Decreased With Phenobarbitone) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Topiramate (Topiramate) SS ORAL ORAL Date:09/24/04ISR Number: 4458173-0Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0272719-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Epival Tablets PS ORAL 370 DAY Initial or Prolonged Condition Aggravated Epival Tablets SS ORAL 370 DAY Hepatic Enzyme Increased Ritonavir Soft Hepatotoxicity Gelatin Capsules SS ORAL 786 DAY Hypomania Ritonavir Soft Nausea Gelatin Capsules SS ORAL 786 DAY Psychotic Disorder Tipranavir SS ORAL 787 DAY Schizophrenia Procyclidine SS ORAL 151 DAY Vomiting Olanzapine SS ORAL 3 YR Olanzapine SS ORAL 3 YR Risperidone SS ORAL 46 DAY Trazodone SS ORAL Quetiapine SS ORAL 23 DAY Lamivudine C ORAL Abacavir C ORAL 24-Jun-2005 12:19 PM Page: 3105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paracetamol C ORAL 618 DAY Atovaquone C ORAL Calcium Carbonate C ORAL Magic Mouthwash C Nystatin C ORAL Megavim C ORAL Date:09/27/04ISR Number: 4459373-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-380797 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Klonopin PS Roche ORAL Paranoia Provigil SS ORAL Zyprexa I ORAL Paxil I ORAL Tobramaxin I ORAL Date:09/27/04ISR Number: 4459474-2Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0273562-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Depakote PS Initial or Prolonged Olanzapine SS Date:09/27/04ISR Number: 4462682-8Report Type:Expedited (15-DaCompany Report #2003UW16014 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Seroquel PS Required Blood Chloride Increased Professional Zyprexa SS ORAL 7.5 MG DAILY Intervention to Blood Potassium Increased PO Prevent Permanent Blood Sodium Increased Zyprexa SS ORAL 15 MG DAILY Impairment/Damage Blood Urea Increased PO Coma Ativan C Confusional State Vistaril C Hepatic Steatosis Metabolic Disorder Obsessive-Compulsive Disorder Pancreatic Necrosis Pancreatitis Haemorrhagic Pressure Of Speech Repetitive Speech Steatorrhoea Toxicologic Test Abnormal Date:09/27/04ISR Number: 4462950-XReport Type:Expedited (15-DaCompany Report #FR_040904720 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Other Weight Increased Health (Olanzapine) Professional (Olanzapine) PS Company Loxapac (Loxapine Representative Succinate) C Other 24-Jun-2005 12:19 PM Page: 3106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/04ISR Number: 4491134-4Report Type:Periodic Company Report #USA040774065 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Consumer Zyprexa-Oral Blood Prolactin Increased (Olanzapine) Crying (Olanzapine) PS Drug Ineffective Strattera Emotional Disorder (Atomoxetine Hypotonia Hydrochloride) SS 40 MG/2 DAY Menstruation Irregular Mood Swings Muscle Twitching Negativism Psychomotor Hyperactivity Date:09/27/04ISR Number: 4497054-3Report Type:Periodic Company Report #USA040464001 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Strattera Hypertension (Atomoxetine Intraocular Pressure Hydrochloride) PS 18 MG DAY Increased Symbyax-Olanzapine 6mg / Fluoxetine 25mg (Olanzapine SS Flonase (Fluticasone Propionate) C Lotensin (Benazepril Hydrochloride) C Penta-Triamterene Hctz C Ditropan Xl (Oxybutynin Hydrochloride) C Pravachol (Pravastatin Sodium) C Prevacid (Lansoprazole) C Ambien (Zolpidem Tartrate) C Restoril (Temazepam) C Aspirin C Vitamins C Date:09/27/04ISR Number: 4498279-3Report Type:Periodic Company Report #USA040670086 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Symbyax-Olanzapine Blood Glucose Increased 12 Mg/ Fluoxetine 25 Somnolence Mg (Olanzapi PS Weight Increased Strattera (Atomoxetine Hydrochloride) SS Zyprexa-Oral (Olanzapine) (Olanzpine) SS Lexapro (Escitalopram) C 24-Jun-2005 12:19 PM Page: 3107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Concerta (Methylphenidate Hydrochloride) C Xanax (Alprazolam) C Prinivil (Lisinopril) C Lipitor (Atorvastatin) C Actonel (Risedronate Sodium) C Serzone (Nefazodone Hydrochloride) C Abilify (Aripiprazole) C Date:09/27/04ISR Number: 4500185-2Report Type:Periodic Company Report #USA040772566 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Strattera Blood Pressure Increased Professional (Atomoxetine Heart Rate Increased Company Hydrochloride) PS 25 MG DAY 1 WK Representative Symbyax-Olanzapine 12 Mg/ Fluoxetine 25 Mg (Olanzapi SS Date:09/27/04ISR Number: 4501724-8Report Type:Periodic Company Report #USA040772120 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Symbyax-Olanzapine Asthenia 12mg / Fluoxetine Diabetes Mellitus 25mg (Olanzapine Major Depression Metformin) PS Mood Swings Zyprexa-Oral Negativism (Olanzapine) Oedema (Olanzapine) SS 10 MG/3 DAY Prescribed Overdose Prozac-Oral Suicidal Ideation (Fluoxetine) Tremor (Fluoxetine Weight Increased Hydrochloride) SS Strattera (Atomoxetine Hydrochloride) SS 60 MG/L IN THE MORNING Geodon (Ziprasidone Hydrochloride) C Seroquel (Quetiapine Fumarate) C Actos (Pioglitazone Hydrochloride) C Diltiazem C Clonidine C Diovan C Paxil (Paroxetine Hydrochloride) C Metformin C 24-Jun-2005 12:19 PM Page: 3108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/04ISR Number: 4501731-5Report Type:Periodic Company Report #USA040361307 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa Initial or Prolonged Aggression Health Zydis-Dispersible Haematemesis Professional (Olanzapine) Hallucination (Olanzapine) PS 5 MG/ 1 AT Hallucinations, Mixed BEDTIME Headache Strattera Hunger (Atomoxetine Intentional Self-Injury Hydrochloride) SS 40 MG/ 1 DAY Psychomotor Hyperactivity Depakote (Valproate Suicidal Ideation Semisodium) C Weight Increased Celexa (Citalopram Hydrobromide) C Ritalin (Methylphenidate Hydrochloride) C Trileptal (Oxcarbazepine) C Ranitdine C Clonidine C Date:09/28/04ISR Number: 4461249-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-380767 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Pegasys PS Roche SUBCUTANEOUS Initial or Prolonged Drug Interaction Zyprexa SS ORAL Extrapyramidal Disorder Efexor C ORAL Malaise Methadone C ORAL Muscle Rigidity Rivotril C ORAL Antabus C ORAL Pantozol C ORAL Remeron C ORAL Trittico C ORAL Copegus I Roche ORAL Copegus I Roche ORAL Date:09/28/04ISR Number: 4461278-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0406391A Age: Gender:Male I/FU:F Outcome PT Other Acquired Porphyria Aggression Agitation Akathisia Allergy To Chemicals Amnesia Arthralgia Asthenia Bipolar Disorder Contrast Media Reaction Convulsion Coordination Abnormal Crying Depression Depression Suicidal Disability 24-Jun-2005 12:19 PM Page: 3109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Dysarthria Dysphemia Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Wellbutrin PS Glaxosmithkline ORAL 42 DAY Electric Shock Tranquilizer SS Encephalopathy Depakote SS Facial Palsy Zyprexa SS Fatigue Alcohol C Feeling Abnormal Head Banging Headache Hyperaesthesia Hypersensitivity Hypoxia Immune System Disorder Injury Insomnia Intentional Self-Injury Mania Mastocytosis Metabolic Encephalopathy Muscle Spasms Myalgia Myoclonus Nervous System Disorder Nightmare Overdose Pain Of Skin Petit Mal Epilepsy Suicidal Ideation Suicide Attempt Temperature Regulation Disorder Throat Tightness Tremor Vestibular Disorder Vomiting Date:09/28/04ISR Number: 4466622-7Report Type:Direct Company Report #CTU 228162 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Zyproxa 20 Mg - Leukopenia Lilly PS Lilly ORAL 20 MG QHS PO Neutrophil Count Abnormal Date:09/29/04ISR Number: 4463633-2Report Type:Expedited (15-DaCompany Report #EWC040940689 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Zyprexa-Rapid-Acting Increased Health Im(Olanzapine) PS 10 MG Circulatory Collapse Professional Contusion Company Dehydration Representative Drug Screen Positive Other Drug Toxicity Fall Skin Laceration 24-Jun-2005 12:19 PM Page: 3110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4463648-4Report Type:Expedited (15-DaCompany Report #JP_040503161 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Steatosis Foreign Zyprexa-Oral Initial or Prolonged High Density Lipoprotein Health (Olanzapine) Other Decreased Professional (Olanzapine) PS 10 MG/1 DAY Hyperphagia Company Risperdal Hypertriglyceridaemia Representative (Risperidone) C Increased Appetite Other Silece Lipase Decreased (Flunitrazepam) C Lipoprotein Deficiency Weight Increased Date:09/29/04ISR Number: 4463674-5Report Type:Expedited (15-DaCompany Report #AU_040908034 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa Hepatic Steatosis Health (Olanzapine) PS ORAL 10 MG/1 DAY Professional Risperidone C Company Mirtazapine Representative (Mirtrazapine) C Other Zolpidem C Date:09/29/04ISR Number: 4463683-6Report Type:Expedited (15-DaCompany Report #JP_040603513 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Condition Aggravated Study (Olanzapine) Irritability Health (Olanzapine) PS 10 MG/1 DAY Polydipsia Professional Hirnamin Psychiatric Symptom Other (Levomepromazine) C Flumezin (Fluphenazine) C Rohipnol (Flunitrazepam) C Amoban (Zopiclone) C Selbex (Teprenone) C Magnesium Oxide C Pursennid C Gaster D (Famotidine) C Date:09/29/04ISR Number: 4463687-3Report Type:Expedited (15-DaCompany Report #JP_040904431 Age:50 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Other Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Cachexia Condition Aggravated Eating Disorder 24-Jun-2005 12:19 PM Page: 3111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Femur Fracture Liver Disorder Malnutrition Report Source Product Role Manufacturer Route Dose Duration Orthostatic Hypotension Foreign Zyprexa Pancytopenia Health (Olanzapine) PS ORAL 15 MG DAY Protein Total Decreased Professional Gasmotin (Mosapride Company Citrate) C Representative Mucosta (Rebamipide) C Other Lac B (Lactobacillis Bifidus, Lypholized) C Berizym C Pravastatin Sodium C Nicotinamide C Date:09/29/04ISR Number: 4463703-9Report Type:Expedited (15-DaCompany Report #DE_040513603 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antidepressant Drug Level Foreign Zyprexa Initial or Prolonged Above Therapeutic Health (Olanzapine) PS NASAL 15 MG DAY Cognitive Disorder Professional Lamitrigine C Condition Aggravated Company Timonil Dehydration Representative (Carbamazepine) C Depression Other Lasix (Furosemide) C Fall Ximovan (Zopiclone) C Femoral Neck Fracture Ebixa (Memantine Mental Disorder Hydrochloride) C Sedation Tramal (Tramadol Hdyrochloride) C Calcium C Date:09/29/04ISR Number: 4463704-0Report Type:Expedited (15-DaCompany Report #EWC040940457 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Zyprexa Cardiovascular Disorder Health (Olanzapine) PS 10 MG DAY Cerebral Atrophy Professional Carbamzepine Cerebral Disorder Other (Carbamzepine) C Cerebral Haemorrhage Fluoxetine Drug Level Above (Fluoxetine) C Therapeutic Levomepromazine C Epilepsy Therapeutic Agent Toxicity Date:09/29/04ISR Number: 4463725-8Report Type:Expedited (15-DaCompany Report #FR_040303749 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa Initial or Prolonged Thrombocytopenia Health White Blood Cell Count Professional (Olanzapine) PS ORAL 10 MG/ 1 DAY Decreased Other Depakote (Valproate Semisodium) C Luteran (Chlormadinone 24-Jun-2005 12:19 PM Page: 3112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetate) C Date:09/29/04ISR Number: 4463742-8Report Type:Expedited (15-DaCompany Report #JP_040904501 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Zyprexa-Oral Initial or Prolonged Phosphatase Increased Study (Olanzapine) Blood Cholinesterase Health (Olanzapine) PS 10 MG/1 DAY Increased Professional Risperdal C-Reactive Protein Other (Risperdal) C Increased Ethyl Loflazepate C Gamma-Glutamyltransferase Rohypnol Increased (Flunitrazepam) C Hepatic Function Abnormal Tiapride Infection Hydrochloride C Pyrexia Carbamazepine White Blood Cell Count (Carbamazepine) C Increased Ipd (Suplatast Tosilate) C Gasmotin (Mosapride Citrate) C Pantosin (Pantethine) C Magnesium Oxide C Sennoside A C Sodium Picosulfate C Date:09/29/04ISR Number: 4463743-XReport Type:Expedited (15-DaCompany Report #FR_040904773 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Zyprexa-Oral Initial or Prolonged Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS 10 MG/1 DAY Difficulty In Walking Other Depakote (Valproate Extrapyramidal Disorder Semisodium) C Fall Lysanxia (Prazepam) C Hyperthermia Levothyrox Hypertonia (Levothyroxine) C Neuroleptic Malignant Surgestrone Syndrome (Promegestone) C Tremor Urinary Tract Infection Date:09/29/04ISR Number: 4463748-9Report Type:Expedited (15-DaCompany Report #EWC040940607 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Olanzapine-Oral Initial or Prolonged Hypertonia Study (Olanzapine) PS 29 DAY Trismus Health Professional Other 24-Jun-2005 12:19 PM Page: 3113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4463750-7Report Type:Expedited (15-DaCompany Report #DE_040914270 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Oral Cerebral Infarction Consumer (Olanzapine) Health (Olanzapine) PS 15 MG DAY Professional Lipid Lowering Agent C Company Representative Other Date:09/29/04ISR Number: 4463752-0Report Type:Expedited (15-DaCompany Report #FR_040904736 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Zyprexa-Oral Initial or Prolonged Gallbladder Disorder Health (Olanzapine) Hepatic Steatosis Professional (Olanzapine) PS 1 DAG FORM Hepatocellular Damage Other DAY Hepatomegaly Mepronizine C Vomiting Tegretol (Carbamazepine) C Seresta (Oxazepam) C Deroxat (Paroxetine Hydrochloride) C Date:09/29/04ISR Number: 4463753-2Report Type:Expedited (15-DaCompany Report #FR_040904720 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Other Weight Increased Health (Olanzapine) Professional (Olanzapine) PS Company Loxapac (Loxapine Representative Succinate) C Other Date:09/29/04ISR Number: 4463754-4Report Type:Expedited (15-DaCompany Report #FR_040904767 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Zyprexa-Oral Initial or Prolonged Faecaloma Health (Olanzapine) Intestinal Obstruction Professional (Olanzapine) PS 30 MG/1 DAY Urinary Retention Other Solian (Amisulpride) C Theralene (Alimemazine Tartrate) C Loxapac (Loxapine Succinate) C Tranxene (Clorazepate Dipotassium) C Piascledine C Lepticur (Tropatepine Hydrochloride) C Sulfarlem (Anethole 24-Jun-2005 12:19 PM Page: 3114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trithione) C Clamoxyl (Amoxicillin Sodium) C Date:09/29/04ISR Number: 4463757-XReport Type:Expedited (15-DaCompany Report #FR_040904745 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Hepatic Steatosis Professional (Olanzapine) PS 5 MG/1 DAY Hypoalbuminaemia Other Tercian Hypoproteinaemia (Cyamemazine) C Hypovolaemic Shock Mopral (Omeprazole) C Inflammation Kredex (Carvedilol) C Ketoacidosis Triatec (Ramipril) C Pancreatitis Acute Femara (Letrozole) C Pancreatitis Necrotising Date:09/29/04ISR Number: 4463759-3Report Type:Expedited (15-DaCompany Report #EWC040940619 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG/1 DAY Other Date:09/29/04ISR Number: 4463925-7Report Type:Expedited (15-DaCompany Report #US_0409105445 Age:42 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Abdominal Pain Other Abdominal Rigidity Alanine Aminotransferase Increased Ascites Blood Amylase Increased Blood Cholesterol Increased Blood Glucose Increased Blood Triglycerides Increased Bowel Sounds Abnormal Calcium Ionised Decreased Candidiasis Gastrointestinal Disorder General Physical Condition Abnormal Glycosylated Haemoglobin Increased Haemodialysis Ketoacidosis Nodule Oedematous Pancreatitis Pancreatic Enlargement Pancreatic Pseudocyst Polydipsia 24-Jun-2005 12:19 PM Page: 3115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polyuria Renal Failure Renal Failure Acute Report Source Product Role Manufacturer Route Dose Duration Respiratory Failure Foreign Zyprexa-Oral Shock Literature (Olanzapine) White Blood Cell Count Health (Olanzapine) PS 10 MG DAY 1 YR Increased Professional Other Date:09/29/04ISR Number: 4463926-9Report Type:Expedited (15-DaCompany Report #JP_040904350 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zyprexa-Oral Initial or Prolonged Consciousness Health (Olanzapine) Drug Toxicity Professional (Olanzapine) PS 10 DSG FORM Intentional Misuse Company DAY Suicide Attempt Representative Tegretol Other (Carbamazepine) C Date:09/29/04ISR Number: 4463927-0Report Type:Expedited (15-DaCompany Report #JP_040904475 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blister Foreign Zyprexa-Oral Dermatitis Exfoliative Health (Olanzapine) Intentional Misuse Professional (Olanzapine) PS Skin Ulcer Other Suicide Attempt Date:09/29/04ISR Number: 4463977-4Report Type:Expedited (15-DaCompany Report #US_0409105286 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Zyprexa-Rapid-Acting Somnolence Health Im (Olanzapine) PS 20 MG/1 Sudden Death Professional Haloperidol C Company Levomepromazine C Representative Diazepam C Other Carbamazepine (Carbamazepine) C Date:09/29/04ISR Number: 4464368-2Report Type:Expedited (15-DaCompany Report #USA040977678 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Symbyax-Olanzapine Other Professional 6mg / Fluoxetine Company 50mg (Olanzapin PS Representative Hydrocodone C Morphine C 24-Jun-2005 12:19 PM Page: 3116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4464666-2Report Type:Expedited (15-DaCompany Report #JP_040904519 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zyprexa-Oral Initial or Prolonged Anxiety Study (Olanzapine) Condition Aggravated Health (Olanzapine) PS 10 MG/ 1 DAY Dyslalia Professional Risperdal Irritability Other (Risperidone) C Rohypnol (Flunitrazepam) C Akineton (Biperiden Lactate) C Date:09/29/04ISR Number: 4464671-6Report Type:Expedited (15-DaCompany Report #FR_040904784 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG /1 DAY Company Depamide Representative (Valpromide) C Other Anafranil (Clomipramine Hydrochloride) C Glucophage (Metformin) C Damicron (Gliclazide) C Date:09/29/04ISR Number: 4464672-8Report Type:Expedited (15-DaCompany Report #FR_040904792 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Purpura Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG/1 DAY Professional Depakote (Valproate Other Semisodium) C Stilnox (Zolpidem Tartrate) C Mopral (Omeprazole) C Tranxene (Clorazepate Dipotassium) C Tercian (Cyamemazine) C Date:09/29/04ISR Number: 4464701-1Report Type:Expedited (15-DaCompany Report #CA_040907260 Age:30 YR Gender:Female I/FU:I Outcome PT Hospitalization - Brief Psychotic Disorder, Initial or Prolonged With Postpartum Onset Decreased Appetite Delusion Delusion Of Reference Depression Drug Exposure During 24-Jun-2005 12:19 PM Page: 3117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Emotional Distress Fatigue Headache Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Foreign Zyprexa-Oral Initial Insomnia Health (Olanzapine) Morbid Thoughts Professional (Olanzapine) PS 5 MG/1 IN THE Paranoia Company EVENING Persecutory Delusion Representative Risperidone C Self Esteem Decreased Other Sertraline C Social Problem Therapy Non-Responder Victim Of Abuse Date:09/29/04ISR Number: 4464704-7Report Type:Expedited (15-DaCompany Report #CA_040907259 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Other Cough Health (Olanzapine) Diabetic Ketoacidosis Professional (Olanzapine) PS Dyspepsia Other Risperdal Nausea (Risperidone) C Pulmonary Oedema Vomiting Date:09/29/04ISR Number: 4465260-XReport Type:Expedited (15-DaCompany Report #US_0409105430 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:09/29/04ISR Number: 4465264-7Report Type:Expedited (15-DaCompany Report #US_0409105543 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:09/29/04ISR Number: 4465462-2Report Type:Expedited (15-DaCompany Report #US_0408104540 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anoxic Encephalopathy Initial or Prolonged Asthenia Other Balance Disorder Blood Glucose Increased Blood Pressure Increased Blood Sodium Increased Bowel Sounds Abnormal Cardiac Disorder Cardiac Function Test Abnormal Cardiac Ventricular Disorder 24-Jun-2005 12:19 PM Page: 3118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Cough Dehydration Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Consumer Zyprexa-Oral Consciousness (Olanzapine) Diabetes Mellitus (Olanzapine) PS 15 MG/1 AT Non-Insulin-Dependent BEDTIME Diabetic Ketoacidosis Humulin-Human Disease Recurrence Insulin (Rdna): 30% Disseminated Regular, 70% Nph (H SS 110 U DAY Intravascular Coagulation Lithium C Dry Mouth Prilosec Dyskinesia (Imeprazole) C Ear Discomfort Levothroid Ear Infection (Levothyroxine Electrocardiogram St Sodium) C Segment Depression Avapro (Irbesartan) C Electroencephalogram Iron Supplement C Abnormal Paxil (Paroxetine Electrolyte Imbalance Hydrochloride) C Hypoglycaemia Lotensin (Benazepril Hypotension Hydrochloride) C Hypothyroidism Desogestrel Hypovolaemia W/Ethinylestradiol C Impaired Gastric Emptying Buspar (Buspirone Lactic Acidosis Hydrochloride) C Lethargy Sarafem (Fluoxetine) C Low Density Lipoprotein Increased Mass Menopausal Symptoms Menorrhagia Oedema Overdose Pancreatic Cyst Pancreatitis Perineal Pain Pharyngitis Pollakiuria Postnasal Drip Pyrexia Renal Failure Acute Respiratory Failure Rhabdomyolysis Sepsis Shock Sinobronchitis Sinus Congestion Sinus Disorder Sinus Tachycardia Tachypnoea Therapeutic Agent Toxicity Thirst Tracheitis Weight Decreased Weight Increased 24-Jun-2005 12:19 PM Page: 3119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4465480-4Report Type:Expedited (15-DaCompany Report #USA040977537 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Consumer Zyprexa-Oral Drug Level Increased Company (Olanzapine) Representative (Olanzapine) PS UNKNOWN Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS UNKNOWN Risperdal (Risperidone) C Miracette C Date:09/29/04ISR Number: 4465486-5Report Type:Expedited (15-DaCompany Report #USA040876553 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Injury Consumer Zyprexa-Oral Initial or Prolonged Dysphonia Other (Olanzapine) Disability Fall (Olanzapine) PS 20 MG/AT Other Memory Impairment NIGHT Myocardial Infarction Prozac-Oral Upper Limb Fracture (Fluoxetine) (Fluoxetine Hydrochloride) SS Lexapro (Escitalopram Oxalate) C Lisinopril C Depakote (Valproate Semisodium) C Date:09/29/04ISR Number: 4465837-1Report Type:Expedited (15-DaCompany Report #USA040978382 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:09/29/04ISR Number: 4465840-1Report Type:Expedited (15-DaCompany Report #US_0409105426 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Pancreatitis (Olanzapine) Renal Failure (Olanzapine) PS Date:09/29/04ISR Number: 4465889-9Report Type:Expedited (15-DaCompany Report #USA040977938 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Death Overdose Health Therapeutic Agent Professional Toxicity Company 24-Jun-2005 12:19 PM Page: 3120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 5 MG IN THE EVENING Paxil (Paroxetine Hydrochloride) C Date:09/29/04ISR Number: 4465891-7Report Type:Expedited (15-DaCompany Report #USA040977733 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Recurrent Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Ssri Antidepressant C Date:09/29/04ISR Number: 4465894-2Report Type:Expedited (15-DaCompany Report #USA040977928 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Date:09/29/04ISR Number: 4465900-5Report Type:Expedited (15-DaCompany Report #USA040978667 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Spontaneous Health Zyprexa-Oral Other Chromosome Abnormality Professional (Olanzapine) Drug Exposure During (Olanzapine) PS Pregnancy Paroxetine C Lithium C Date:09/29/04ISR Number: 4465905-4Report Type:Expedited (15-DaCompany Report #USA040977777 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Height Decreased Consumer Zyprexa-Oral Initial or Prolonged Impaired Work Ability (Olanzapine) Disability Psychomotor Hyperactivity (Olanzapine) PS 5 MG AT Transient Ischaemic BEDTIME Attack Clonazepam C Weight Increased Depakote (Valproate Semisodium) C Pravachol (Pravastatin Sodium) C Ranitidine C Levothyroxine C Benadryl (Diphenhydramine Hydrochloride) C Gemfibrozil C Lisinopril 24-Jun-2005 12:19 PM Page: 3121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lisinopril) C Darvocet-N C Aggrenox C Coreg (Carvedilol) C Date:09/30/04ISR Number: 4463228-0Report Type:Expedited (15-DaCompany Report #PHBS2004TW12878 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Exelon PS Novartis Sector: Extrapyramidal Disorder Pharma ORAL 6 mg/d 70 DAY Exelon SS Novartis Sector: Pharma ORAL 9 mg/d Olanzapine SS UNKNOWN Date:10/01/04ISR Number: 4463701-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908884 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Tylox PS OROPHARINGEAL Methadone SS OROPHARINGEAL Olanzapine SS OROPHARINGEAL Date:10/01/04ISR Number: 4464008-2Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0265646-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Depakote Tablets PS ORAL Initial or Prolonged Coma Depakote Tablets SS ORAL Depressed Level Of Depakote Tablets SS ORAL Consciousness Depakote Tablets SS Up to 1500 Diet Refusal Milligram Drug Interaction Depakote Tablets SS ORAL Hyperammonaemia Clobazam C ORAL 9 DAY Memory Impairment Oxybutynin C ORAL Oxazepam I ORAL 200 to 400 Milligram Olanzapine I ORAL 10 DAY Date:10/01/04ISR Number: 4465764-XReport Type:Direct Company Report #CTU 228539 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Symbyax 9 Mg/ 25 Other Movement Disorder Mg Lilly PS Lilly ORAL 1 PILL ONCE Weight Increased PER DAY ORAL Symbyax SS Date:10/01/04ISR Number: 4478455-6Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12692117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Abilify Tabs 10 Mg PS Otsuka Drug Withdrawal Syndrome Professional Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Muscle Strain Zyprexa SS ORAL Nausea Fluctine C ORAL 24-Jun-2005 12:19 PM Page: 3122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/04ISR Number: 4465386-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381370 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Rivotril PS Roche INTRAMUSCULAR A TOTAL OF 3. Initial or Prolonged Blood Creatine Tercian SS ORAL Phosphokinase Increased Otrasel C Drug Interaction Parlodel C Myoglobinuria Zyprexa I INTRAMUSCULAR TOTAL OF 5 Psychotic Disorder Modopar I Roche UNKNOWN Somnolence Modopar I Roche UNKNOWN RESTARTED AFTER A BREAK OF 48 HOURS. Date:10/04/04ISR Number: 4467131-1Report Type:Direct Company Report #CTU 228720 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Communication Disorder Zyprexa (Lilly) PS Lilly ORAL 20 MG BID PO Initial or Prolonged Somnolence Date:10/04/04ISR Number: 4467171-2Report Type:Direct Company Report #CTU 228582 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Symbyax 6-25 Mg Initial or Prolonged Non-Insulin-Dependent Lilly PS Lilly ORAL Q DAY /PO Required Pancreatitis Intervention to Prevent Permanent Impairment/Damage Date:10/04/04ISR Number: 4467782-4Report Type:Expedited (15-DaCompany Report #S04-GER-04874-01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Cipramil (Citalopram Initial or Prolonged Coma Health Hydrobromide) PS ORAL 10 TABLET PO Dyskinesia Professional Cipramil (Citalopram Hypotonia Company Hydrobromide) SS Overdose Representative Olanzapine SS Pupillary Reflex Impaired Suicide Attempt Treatment Noncompliance Unevaluable Event Date:10/05/04ISR Number: 4470662-1Report Type:Expedited (15-DaCompany Report #2004069958 Age:29 YR Gender:Female I/FU:I Outcome PT Hospitalization - Decreased Appetite Initial or Prolonged Delusion Of Reference Depressed Mood Depressive Symptom Fatigue Headache Insomnia Paranoia 24-Jun-2005 12:19 PM Page: 3123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Persecutory Delusion Self Esteem Decreased Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Sertraline Health (Sertraline) PS ORAL 50 MG )50 MG, Professional 1 IN 1 D), ORAL Olanzapine (Olanzapine) SS ORAL 5 MG (5 MG, 1 IN 1 D), ORAL Date:10/06/04ISR Number: 4467216-XReport Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0275099-00 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Depakote Tablets PS ORAL Hospitalization - Aphasia Lithium SS ORAL Initial or Prolonged Blood Creatinine Olanzapine SS ORAL Increased Blood Glucose Increased Confusional State Hypernatraemia Mutism Nephrogenic Diabetes Insipidus Pyrexia Tremor Urinary Incontinence Date:10/06/04ISR Number: 4470710-9Report Type:Expedited (15-DaCompany Report #2004UW20262 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Foreign Seroquel PS 25 MG DAILY 10 DAY Consciousness Health Zyprexa SS 3.75 MG DAILY 60 DAY Musculoskeletal Stiffness Professional Phenytoin SS ORAL 300 MG DAILY Opisthotonus Other PO Citalopram SS ORAL 40 MG DAILY PO Aricept SS ORAL 10 MG DAILY PO Crestor C Acetaminophen C Aspirin (E.C.) C Multivitamins C Senna C Date:10/06/04ISR Number: 4471525-8Report Type:Expedited (15-DaCompany Report #2004053261 Age:34 YR Gender:Male I/FU:F Outcome PT Hospitalization - Convulsion Initial or Prolonged Metastases To Central Other Nervous System Nuclear Magnetic Resonance Imaging Brain Abnormal Post Procedural Nausea 24-Jun-2005 12:19 PM Page: 3124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Refusal Of Treatment By Patient Report Source Product Role Manufacturer Route Dose Duration Treatment Noncompliance Consumer Zoloft (Sertraline) PS ORAL 50 MG (50 MG, Health 1 IN 1 D), Professional ORAL Olanzapine SS ORAL 10 MG (10 MG, 1 IN 1 D), ORAL Antineoplastic Agents (Antineoplastic Agents) SS INTRAVENOUS INTRAVENOUS Allopurinol (Allopurinol) SS Date:10/07/04ISR Number: 4473184-7Report Type:Direct Company Report #USP 56893 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Cymbalta PS Eli Lilly TROCHE/LOZENG E Symbyax SS Eli Lilly TROCHE/LOZENG E Date:10/08/04ISR Number: 4472080-9Report Type:Expedited (15-DaCompany Report #2004071079 Age:56 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amlodipine Intentional Misuse Health (Amlodipine) PS Professional Olanzapine (Olanzapine) SS Zolpidem (Zolpidem) SS Date:10/08/04ISR Number: 4472182-7Report Type:Expedited (15-DaCompany Report #USA040978086 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 2.5 MG Zyrtec (Cetirizine Hydrochloride) C Date:10/08/04ISR Number: 4472197-9Report Type:Expedited (15-DaCompany Report #US_0407104110 Age:57 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Abdominal Hernia Other Abnormal Behaviour Accidental Overdose Agitation Anger Animal Bite Arthralgia 24-Jun-2005 12:19 PM Page: 3125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Arthropathy Asthenia Back Pain Report Source Product Role Manufacturer Route Dose Duration Bronchitis Consumer Prozac-Oral Burning Sensation Health (Fluoxetine) Bursitis Professional (Fluoxetine Cellulitis Company Hydrochloride) PS 40 MG DAY Colonic Polyp Representative Zyprexa-Oral Diarrhoea (Olanzapine) Diarrhoea Haemorrhagic (Olanzapine) SS 20 MG/1 AT Drug Ineffective BEDTIME Epicondylitis Clonazepam C Erectile Dysfunction Fluiticasone Erythema Propionate C Fall Guaifenesin Feeling Abnormal (Guaifenesin L.A.) C Gun Shot Wound Hydrochlorothiazide C Head Injury Lansoprazole C Headache Lisinopril Hostility (Lisinopril) C Hyperhidrosis Morphine Sulfate C Joint Injury Naproxen (Naproxen Laceration Sodium) C Lethargy Sildenafil Citrate C Lip Pain Simvastatin Loss Of Consciousness "Orifarm" Nausea (Simvastatin Oedema Ratiopharm) C Oedema Peripheral Effexor (Venlafaxine Osteoarthritis Hydrochloride) C Pain Venlafaxine C Pain Of Skin Rabeprazole C Pneumonia Lovastatin C Poisoning Percocet C Pruritus Tramadol C Rectal Haemorrhage Motrin (Ibuprofen) C Rotator Cuff Syndrome Omeprazole C Sedation Albuterol C Sinusitis Skin Laceration Somnolence Stress Suicidal Ideation Suicide Attempt Tachycardia Tendonitis Tooth Disorder Treatment Noncompliance Viral Upper Respiratory Tract Infection Weight Increased Wound Xanthogranuloma Date:10/08/04ISR Number: 4472202-XReport Type:Expedited (15-DaCompany Report #USA040979069 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Death Dyskinesia Health Professional 24-Jun-2005 12:19 PM Page: 3126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG Date:10/08/04ISR Number: 4472208-0Report Type:Expedited (15-DaCompany Report #US_0409106125 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:10/08/04ISR Number: 4472590-4Report Type:Expedited (15-DaCompany Report #FR_040904844 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Company Prozac-Oral Representative (Fluoxetine) Other (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Tercian (Cyamemazine) C Imovane (Zopiclone) C Lysanxia (Prazepam) C Methadone C Subutex (Buprenorphine Hydrochloride) C Date:10/08/04ISR Number: 4472591-6Report Type:Expedited (15-DaCompany Report #FR_040804601 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Blood Potassium Decreased Health (Olanzapine) Brain Oedema Professional (Olanzapine) PS 15 MG/1 DAY Coma Other Tercian Convulsion (Cyamemazine) C Creatinine Urine Increased Hyponatraemia Hyporeflexia Loss Of Consciousness Metabolic Disorder Polydipsia Psychogenic Psychomotor Agitation Thyroxine Free Increased Urine Chloride Urine Sodium Vomiting 24-Jun-2005 12:19 PM Page: 3127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4472595-3Report Type:Expedited (15-DaCompany Report #EWC040940724 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Olanzapine-Oral Health (Olanzapine) PS 10 MG Professional Company Representative Other Date:10/08/04ISR Number: 4472597-7Report Type:Expedited (15-DaCompany Report #FR_040904825 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa-Oral Hospitalization - Aphasia Health (Olanzapine) Initial or Prolonged Confusional State Professional (Olanzapine) PS 17.5 MG/1 DAY Glasgow Coma Scale Other Teralithe (Lithium Abnormal Carbonate) C Hypernatraemia Depakote (Valproate Incontinence Semisodium) C Mutism .. C Nephrogenic Diabetes .. C Insipidus Pyrexia Tremor Date:10/08/04ISR Number: 4472602-8Report Type:Expedited (15-DaCompany Report #FR_040904843 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Foreign Zyprexa-Oral Initial or Prolonged Self-Medication Health (Olanzapine) Professional (Olanzapine) PS 1 DG FORM/1 Other DAY Date:10/08/04ISR Number: 4472603-XReport Type:Expedited (15-DaCompany Report #FR_040904821 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Rapid-Acting Initial or Prolonged Phosphokinase Increased Health Im (Olanzapine) PS INTRAMUSCULAR 5 MG DAY IM Blood Lactate Professional Modopar C Dehydrogenase Increased Other Parlodel C Myoglobinuria Selegiline C Somnolence Date:10/08/04ISR Number: 4472604-1Report Type:Expedited (15-DaCompany Report #JP_040904591 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gamma-Glutamyltransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Paxil (Paroxetine Representative Hydrochloride) C Other Dogmatyl (Sulpiride) C 24-Jun-2005 12:19 PM Page: 3128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexotan (Bromazepam) C Date:10/08/04ISR Number: 4472605-3Report Type:Expedited (15-DaCompany Report #EWC040940693 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Rupture Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS INTRAMUSCULAR 10 MG/1 IM Professional Solian (Amisulpride) C Company Nipolept (Zotepine) C Representative Antihypertensive C Other Ferrum (Ferrous Fumarate) C Date:10/08/04ISR Number: 4473839-4Report Type:Direct Company Report #CTU 229129 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Olanzapine PS ORAL 20 MG PO QD Date:10/08/04ISR Number: 4473897-7Report Type:Expedited (15-DaCompany Report #USA040978772 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Consumer Zyprexa-Oral Initial or Prolonged Fluctuation (Olanzapine) Disability Dysphagia (Olanzapine) PS 5 MG 1 YR Speech Disorder Neurontin (Gabapentin) C Aricept (Donepezil Hydrochloride) C Vioxx (Rofecoxib) C Zoloft (Sertraline Hydrochloride) C Date:10/08/04ISR Number: 4473898-9Report Type:Expedited (15-DaCompany Report #USA040978800 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Zyprexa-Oral Hospitalization - Intentional Misuse (Olanzapine) Initial or Prolonged (Olanzapine) PS 20 MG Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG Trilafon (Perphenazine) C Klonopin (Clonazepam) C Fosamax (Alendronate Sodium) C Geodon (Ziprasidone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4473899-0Report Type:Expedited (15-DaCompany Report #USA040978292 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Test Abnormal Consumer Zyprexa-Oral Hospitalization - Diabetes Mellitus (Olanzapine) Initial or Prolonged Haematochezia (Olanzapine) PS Weight Increased Risperidone C Date:10/08/04ISR Number: 4473900-4Report Type:Expedited (15-DaCompany Report #USA040978742 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Zyprexa-Oral Initial or Prolonged Medication Error Professional (Olanzapine) (Olanzapine) PS 10 MG Date:10/08/04ISR Number: 4473901-6Report Type:Expedited (15-DaCompany Report #USA040875914 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Olanzapine-Oral Non-Insulin-Dependent (Olanzapine) PS Hyperglycaemia Fosinopril C Myocardial Infarction Hydrochlorothiazide C Post-Traumatic Stress Naprosyn (Naproxen Disorder Mepha) C Weight Increased Baclofen C Date:10/08/04ISR Number: 4473917-XReport Type:Expedited (15-DaCompany Report #USA040978500 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Symbyax-Olanzapine / Professional Fluoxetine (Unknown Company Dose) (Ola PS Representative Date:10/08/04ISR Number: 4473918-1Report Type:Expedited (15-DaCompany Report #USA040978997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/1 DAY Zoloft (Sertraline Hydrochloride) C Date:10/08/04ISR Number: 4473994-6Report Type:Expedited (15-DaCompany Report #USA040978382 Age: Gender:Male I/FU:F Outcome PT Report Source Death Intentional Misuse Health Professional 24-Jun-2005 12:19 PM Page: 3130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:10/08/04ISR Number: 4473997-1Report Type:Expedited (15-DaCompany Report #USA040876437 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Zyprexa-Oral Completed Suicide Professional (Olanzapine) Gun Shot Wound Company (Olanzapine) PS 5 MG DAY Loss Of Employment Representative Mood Altered Obsessive-Compulsive Disorder Relationship Breakdown Treatment Noncompliance Date:10/08/04ISR Number: 4474069-2Report Type:Expedited (15-DaCompany Report #US_0408104540 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Balance Disorder Other Blood Sodium Increased Bowel Sounds Abnormal Bronchitis Cardiac Disorder Cerebral Ischaemia Cholecystectomy Coma Cough Dehydration Diabetes Mellitus Non-Insulin-Dependent Diabetic Ketoacidosis Disseminated Intravascular Coagulation Dry Mouth Ear Infection Electrocardiogram St Segment Depression Hypertension Hypoglycaemia Hypotension Hypovolaemia Impaired Gastric Emptying Lethargy Low Density Lipoprotein Increased Mass Menopausal Symptoms Menorrhagia Metabolic Acidosis Nervous System Disorder Overdose 24-Jun-2005 12:19 PM Page: 3131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pancreatic Cyst Pancreatitis Perineal Pain Report Source Product Role Manufacturer Route Dose Duration Pharyngitis Consumer Zyprexa-Oral Pollakiuria Health (Olanzapine) Renal Failure Professional (Olanzapine) PS 15 MG/1 AT Renal Failure Acute BEDTIME Respiratory Failure Humulin-Human Rhabdomyolysis Insulin (Rdna) :30% Sepsis Regular, 70% Nph (H SS 110 U DAY Shock Lithium C Sinobronchitis Prilosec Sinus Congestion (Omeprazole) C Sinus Disorder Levothyroid Sinus Tachycardia (Levothyroxine Sinusitis Sodium) C Therapeutic Agent Avapro (Irbesartan) C Toxicity Iron Supplement C Thirst Paxil (Paroxetine Weight Decreased Hydrochloride) C Weight Increased Lotensin (Benazepril Hydrochloride) C Desogestrel W/Ethinylestradiol C Buspar (Buspirone Hydrochloride) C Sarafem (Fluoxetine) C Effexor (Venlafaxine Hydrochloride C Multivitamin C Date:10/08/04ISR Number: 4474071-0Report Type:Expedited (15-DaCompany Report #USA040875747 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Venous Thrombosis Limb Consumer Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Other Professional (Olanzapine) PS 2.5 MG DAY Risperdal (Risperidone) C Percocet C Xalatan (Latanoprost) C Cosopt C Date:10/08/04ISR Number: 4474115-6Report Type:Expedited (15-DaCompany Report #04P-056-0265646-00 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Depakote Tablets Initial or Prolonged Amnesia Health (Depakote) Coma Professional Divalproex Sodium) Depressed Level Of (Divalproex Sodium) PS ORAL SEE IMAGE Consciousness Oxazepam SS ORAL 200 MG TO 400 Diet Refusal MG, ORAL Drug Interaction Olanzapine SS ORAL 20 MG, 1 IN 1 Hyperammonaemia D, PER ORAL Clobazam C Oxybutynin C 24-Jun-2005 12:19 PM Page: 3132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4474181-8Report Type:Expedited (15-DaCompany Report #2004-DE-04954GD Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Literature Clonidine Required Dyspnoea (Clonidine) PS Intervention to Ileus Hydromorphone Prevent Permanent (Hydromorphone) SS INTRAVENOUS 30 MG/H, IV Impairment/Damage Midazolam (Midazolam) SS INTRAVENOUS 20 MG/H, IV Diazepam (Diazepam) SS 900 MG, SEE TEXT Fentanyl (Fentanyl) SS INTRAVENOUS 700 MCG/H, IV Propofol (Propofol) SS INTRAVENOUS 300 MG/H, IV Olanzapine (Olanzapine) SS Date:10/08/04ISR Number: 4474194-6Report Type:Expedited (15-DaCompany Report #EWC031137009 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Zyprexa Health (Olanzapine) PS ORAL 10 MG/ IN THE Professional EVENING Company Haldol (Haloperidol) C Representative Cisordinol Other (Clopenthixol Hydrochloride) C Lithium C Date:10/08/04ISR Number: 4474196-XReport Type:Expedited (15-DaCompany Report #JP_040202677 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa Initial or Prolonged Increased Study Other Aspartate Health (Olanzapine) PS ORAL 10 MG/1 DAY Aminotransferase Professional Ciproxan Increased Other (Ciprofloxacin Blood Creatine Hydrochloride) C Phosphokinase Increased Serenace Blood Lactate (Halopperidol) C Dehydrogenase Increased Akineton (Biperiden Hepatic Function Abnormal Hydrochloride) C Influenza Diazepam C Pyrexia Rohypnol (Flunitrazepam) C Date:10/08/04ISR Number: 4474263-0Report Type:Expedited (15-DaCompany Report #CA_040707125 Age:24 YR Gender:Male I/FU:F Outcome PT Hospitalization - Amnesia Initial or Prolonged Bedridden Other Brain Damage Drug Abuser Electroencephalogram Abnormal Fall 24-Jun-2005 12:19 PM Page: 3133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Abnormal Food Craving Grand Mal Convulsion Report Source Product Role Manufacturer Route Dose Duration Hyperkinesia Foreign Zyprexa- Oral Impaired Work Ability Consumer (Olanzapine) Loss Of Consciousness Other (Olanzapine) PS 10 MG DAY Somnolence Urinary Incontinence Weight Fluctuation Date:10/08/04ISR Number: 4474264-2Report Type:Expedited (15-DaCompany Report #JP_040904599 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Risperdal Representative (Risperidone) C Other Hydantol (Phenytoin C Neophyllin (Aminophylline) C Benzalin (Nitrazepam) C Date:10/08/04ISR Number: 4474266-6Report Type:Expedited (15-DaCompany Report #DE_040914320 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Delta Foreign Zyprexa-Oral Initial or Prolonged Waves Abnormal Health (Olanzapine) Myoclonus Professional (Olanzapine) PS 10 MG DAY Other L-Thyroxine C Amineurin (Amitriptyline Hydrochloride) C Date:10/08/04ISR Number: 4474607-XReport Type:Expedited (15-DaCompany Report #FR_040904820 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Zyprexa-Rapid-Acting Initial or Prolonged Fall Health Im (Olanzapine) PS 10 MG /1 DAY Hypotension Professional Malaise Other Pallor Syncope Vasovagal Date:10/08/04ISR Number: 4474610-XReport Type:Expedited (15-DaCompany Report #EWC040940716 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Foreign Olazapine-Oral Initial or Prolonged Drug Interaction Health (Olanzapine) PS 5 MG DAY-FEW Extrapyramidal Disorder Professional MONTHS MON Feeling Abnormal Other Pegasys Parkinsonism (Peginterferon 24-Jun-2005 12:19 PM Page: 3134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alfa-2a)Pegus (Ribavirin) C Efexor Er (Venlafaxine Hydrochloride) C Methadone C Trittico (Trazodone Hydrochloride) C Rivotril (Clonazepam) C Rmeron (Mirtazapine) C Antabus (Disulfiram) C Pantozol (Pantoprazole Sodium) C Copegus(Ribavirin) C Date:10/08/04ISR Number: 4474611-1Report Type:Expedited (15-DaCompany Report #CA_040907271 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anticonvulsant Drug Level Foreign Olanzapine -Oral Increased Study (Olanzapine) PS 15 MG IN THE Blood Chloride Decreased Health EVENING Blood Cholesterol Professional Epival (Valproate Increased Other Semisodium) SS 1500 MG IN Blood Sodium Decreased THE EVENING Fungal Rash Clonazepam C Insomnia Zopiclone Low Density Lipoprotein (Zopiclone) C Increased Losec (Omeprazole Restless Legs Syndrome Magnesium) C Vioxx (Rofecoxib) C Date:10/08/04ISR Number: 4474613-5Report Type:Expedited (15-DaCompany Report #JP_040904608 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Dogmatyl *Sulpiride) C Representative Seniran (Bromazepam) C Other Halcion (Triazolam) C Lack B (Lactobacillus Bifidus, Lyophilized) C Date:10/08/04ISR Number: 4474614-7Report Type:Expedited (15-DaCompany Report #EWC040940743 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) PS 20 MG DAY Professional Oxcarbazepine C Company Quetiapine C Representative Other 24-Jun-2005 12:19 PM Page: 3135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/04ISR Number: 4474718-9Report Type:Expedited (15-DaCompany Report #2004071941 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Zoloft (Sertraline) PS Hospitalization - Lung Disorder Health Olanzapine Initial or Prolonged Multiple Drug Overdose Professional (Olanzapine) SS Other Pleural Disorder Company Bromazepam Suicide Attempt Representative (Bromazepam) SS Date:10/12/04ISR Number: 4475249-2Report Type:Expedited (15-DaCompany Report #2003UW16014 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Seroquel PS Required Asthenia Professional Seroquel SS 175 MG DAILY Intervention to Blood Chloride Increased Zyprexa SS ORAL 7.5 MG DAILY Prevent Permanent Blood Glucose Increased PO Impairment/Damage Blood Pressure Zyprexa SS ORAL 15 MG DAILY Immeasurable PO Blood Sodium Increased Zyprexa SS 10 MG HS Blood Urea Increased Zyprexa SS 3 DF QD Cardio-Respiratory Arrest Ativan C Coma Vistaril C Coronary Artery Disease Depo-Provera C Drug Level Increased Advil C Headache Ambien C Hepatic Steatosis Septra Ds C Metabolic Disorder Metronidazole C Pancreatic Necrosis Doxycycline C Pancreatitis Acute Temazepam C Pancreatitis Haemorrhagic Roxicet C Pulse Absent Pupil Fixed Treatment Noncompliance Urinary Tract Infection Vomiting Date:10/12/04ISR Number: 4475974-3Report Type:Expedited (15-DaCompany Report #2004071162 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Lithium (Lithium) PS ORAL ORAL Other Completed Suicide Health Olanzapine Intentional Misuse Professional (Olanzapine) SS ORAL ORAL Venlafaxine (Venlafaxine) SS ORAL ORAL All Other Therapeutic Products SS ORAL ORAL Date:10/12/04ISR Number: 4476453-XReport Type:Expedited (15-DaCompany Report #2004071266 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS Multiple Drug Overdose Professional Olanzapine (Olanzapine) SS Clonazepam 24-Jun-2005 12:19 PM Page: 3136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) SS Date:10/12/04ISR Number: 4476492-9Report Type:Expedited (15-DaCompany Report #2004070516 Age:20 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Hydroxyzine Health Hydrochloride Professional (Tablet) (Hydroxyzine Hydrochloride) PS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Triamterene (Triamterene) SS ORAL ORAL All Other Therapeutic Products (All Other Therapeutic Products) SS ORAL ORAL Date:10/12/04ISR Number: 4477592-XReport Type:Expedited (15-DaCompany Report #DE_040713949 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa Life-Threatening Hypotension Health (Olanzapine) PS INTRAMUSCULAR 10 MG/1 DAY Hospitalization - Pulse Abnormal Professional Haldol Initial or Prolonged Suicide Attempt Company -Janssen Decanoat Syncope Representative (Haloperidol Ventricular Fibrillation Other Decanoate) C Janssen Haldol (Haloperidol) C Janssen-Cilag Tavor (Lorazepam) C 2.5MG/DAY Date:10/13/04ISR Number: 4473939-9Report Type:Expedited (15-DaCompany Report #2004S1002504 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zonegran Elan PS SEE IMAGE Initial or Prolonged Anticonvulsant Drug Level Pehnytek Capsyles Other Below Therapeutic 300mg Mylan Bertek Blood Cholesterol (A Subsidiary Of Increased Mylan Laboratories) SS Mylan Bertek Condition Aggravated Laboratories ORAL 300 MG BID Dementia Alzheimer'S Type THEN 300MG QD Grand Mal Convulsion Phenytek Capsules 200 Mg Mylan Bertek (A Subsidiary Of Mylan Laboratories) SS Mylan Bertek ORAL SEE IMAGE Zyprexa Lilly SS Lilly ORAL ORAL Escitalopram C Lorazepam C Diazepam C Donepezil C Clorazepate C Celecoxib C Simvastatin C 24-Jun-2005 12:19 PM Page: 3137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/04ISR Number: 4474315-5Report Type:Direct Company Report #CTU 229525 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Olanzapine 20-40 Mg PS ORAL 20 MG DAILY Non-Insulin-Dependent ORAL Extrapyramidal Disorder Weight Increased Date:10/13/04ISR Number: 4475218-2Report Type:Direct Company Report #CTU 229492 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Zyprexa Lilly PS Lilly ORAL ORAL Initial or Prolonged Blood Creatine Phosphokinase Increased Confusional State Electrocardiogram Abnormal Hyperhidrosis Weight Decreased Date:10/13/04ISR Number: 4476502-9Report Type:Expedited (15-DaCompany Report #US_0410106321 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Consumer Zyprexa-Oral (Olanzapine) PS Date:10/13/04ISR Number: 4476503-0Report Type:Expedited (15-DaCompany Report #US_0410106320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) PS Date:10/13/04ISR Number: 4476504-2Report Type:Expedited (15-DaCompany Report #US_0409106145 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Professional (Olanzapine) PS Other Road Traffic Accident Abilify (Aripiprazole) C Date:10/13/04ISR Number: 4476505-4Report Type:Expedited (15-DaCompany Report #US_0407104266 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Consumer Zyprexa-Dispersible Initial or Prolonged Diabetes Mellitus Health (Olanzapine) PS 30 MG/DAY 26 MON Huntington'S Chorea Professional Cogentin Psychotic Disorder (Benzatropine Tooth Impacted Mesilate) C Weight Increased Trileptal (Oxcarbazepine) C Effexor-Xr 24-Jun-2005 12:19 PM Page: 3138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Venlafaxine Hydrochloride) C Aricept (Donepezil Hydrochloride) C Seroquel (Quetiapine Fumarate) C Provigil (Modafinil) C Trilafon (Perphenazine Enantate) C Glucophage (Metformin) C Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Zonegran (Zonisamide) C Date:10/13/04ISR Number: 4476506-6Report Type:Expedited (15-DaCompany Report #US_0406103675 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Zyprexa-Oral Initial or Prolonged Anger (Olanzapine) PS 40 MG AT Other Anxiety BEDTIME Apathy Abilify Blood Glucose Fluctuation (Aripiprazole) C Depressed Level Of Wellbutrin Sr Consciousness (Bupropion Depression Hydrochloride) C Disease Recurrence Paxil (Paroxetine Disturbance In Attention Hydrochloride) C Diverticulitis Antabuse Dizziness (Disulfiram) C Fatigue Spironolactone Flat Affect (Spironolactone) C Headache Lithium Carbonate C Hyperphagia Hypotension Loss Of Consciousness Muscle Spasms Muscle Twitching Nightmare Weight Increased Date:10/13/04ISR Number: 4476516-9Report Type:Expedited (15-DaCompany Report #USA040979162 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Metronidazole C Topiramate C Clonazepam C 24-Jun-2005 12:19 PM Page: 3139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/04ISR Number: 4476517-0Report Type:Expedited (15-DaCompany Report #USA040360918 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Zyprexa-Oral Arrhythmia Professional (Olanzapine) Sudden Death (Olanzapine) PS 10 MG/EVERY DAY 2 MON Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG Date:10/13/04ISR Number: 4476632-1Report Type:Expedited (15-DaCompany Report #USA040979381 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Neoplasm Malignant Health Zyprexa-Oral Maculopathy Professional (Olanzapien) (Olanzapine) PS 20 MG/1 DAY Paxil (Paroxetine Hydrochloride) C Date:10/13/04ISR Number: 4476634-5Report Type:Expedited (15-DaCompany Report #USA040979222 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bacterial Infection Health Zyprexa-Oral Colonic Obstruction Professional (Olanzapine) Hepatic Enzyme Increased Company (Olanzapine) PS 5 MG/1 DAY 1 WK Sepsis Representative Date:10/13/04ISR Number: 4476637-0Report Type:Expedited (15-DaCompany Report #USA040979090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Zyprexa-Oral Company (Olanzapine Representative (Olanzapine) PS Date:10/13/04ISR Number: 4476738-7Report Type:Expedited (15-DaCompany Report #USA040258152 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Consumer Zyprexa-Oral Ear Congestion (Olanzapine) Glucose Tolerance (Olanzapine) PS 15 MG DAY Impaired Zoloft (Sertraline Hepatocellular Damage Hydrochloride) C Somnolence Weight Increased 24-Jun-2005 12:19 PM Page: 3140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/04ISR Number: 4476743-0Report Type:Expedited (15-DaCompany Report #USA040979143 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Cymbalta (Duloxetine Initial or Prolonged Pancreatitis Acute Professional Hydrochloride) PS 30 MG DAY Psychomotor Hyperactivity Zyprexa-Oral (Olanzapine)(Olanzap ine) SS 5 MG DAY Neurontin (Gabapentin Pfizer) C Serax (Oxazepam) C Acetaminophen W/Hydrocodone C Date:10/13/04ISR Number: 4476761-2Report Type:Expedited (15-DaCompany Report #USA040979383 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Cymbalta (Duloxetine Other Congenital Cardiovascular Professional Hydrochloride) PS 60 MG DAY 2 WK Anomaly Zyprexa-Oral Treatment Noncompliance (Olanzapine) (Olanzapine) SS 20 MG DAY 2 WK Date:10/13/04ISR Number: 4476794-6Report Type:Expedited (15-DaCompany Report #USA040979215 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Gun Shot Wound Professional 6mg / Fluoxetine Intentional Self-Injury Company 25mg PS Representative Cymbalta (Duloxetine Hydrohcloride) SS 60 MG Hydrocodone C Date:10/13/04ISR Number: 4476925-8Report Type:Expedited (15-DaCompany Report #FR_040904845 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytolytic Hepatitis Foreign Zyprexa-Oral Hepatocellular Damage Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Tercian (Cyamemazine) C Date:10/13/04ISR Number: 4476937-4Report Type:Expedited (15-DaCompany Report #GBS040915659 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Zyprexa Completed Suicide Health (Olanzapine) PS ORAL 10 MG Professional Other 24-Jun-2005 12:19 PM Page: 3141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/04ISR Number: 4476938-6Report Type:Expedited (15-DaCompany Report #JP_041004651 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Company Rohypnol Representative (Flunitrazepam Eg) C Other Date:10/13/04ISR Number: 4476939-8Report Type:Expedited (15-DaCompany Report #GBS040915669 Age:21 WK Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Olanzapine Drug Exposure During Health -Oral (Olanzapine) PS TRANSPLACENTAL Pregnancy Professional Folic Acid C TRANSPLACENTAL Other Nicorette Patch (Nicotine) C Co-Proxamol C Codeine Phosphate C Date:10/13/04ISR Number: 4477310-5Report Type:Expedited (15-DaCompany Report #2004CG01970 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Mopral PS Initial or Prolonged Hypercapnia Other Xanax SS Malnutrition Effexor SS Pneumonia Zyprexa SS Somnolence Date:10/13/04ISR Number: 4477363-4Report Type:Expedited (15-DaCompany Report #FR_041004906 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicidal Ideation Foreign Zyprexa-Oral Health (Olanzapine) PS 30 MG DAY Professional Tercian Company (Chyamemazine) C Representative Haldol Decanoate Other (Haloperidol Decanoate) C Date:10/13/04ISR Number: 4477378-6Report Type:Expedited (15-DaCompany Report #EWC040940807 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Haemorrhage Foreign Zyprexa-Oral Hospitalization - Health (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Professional Perindopril C Disability Other 24-Jun-2005 12:19 PM Page: 3142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/04ISR Number: 4477534-7Report Type:Expedited (15-DaCompany Report #JP_040904442 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa Initial or Prolonged Abnormal Sleep-Related Health Event Professional (Olanzapine) PS ORAL 5 MG DAY Amnesia Company Risperdal Representative (Risperidone) C Other Akineton (Biperiden Lactate) C Lendormin (Brotizolam) C Date:10/13/04ISR Number: 4477594-3Report Type:Expedited (15-DaCompany Report #EWC040639753 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa-Rapid-Acting Other Logorrhoea Health (Olanzapine) PS INTRAMUSCULAR 10 MG Restlessness Professional Risperdal Consta Sedation Company (Risperidone) C Sudden Cardiac Death Representative Rivotril Other (Clonazepam) C Risperdal (Risperidone) C Tranxilium (Clorazepate Dipotassium) C Depakine (Valproate Sodium) C Haloperidol C Date:10/13/04ISR Number: 4477596-7Report Type:Expedited (15-DaCompany Report #CA_010403514 Age:45 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Disability Blood Alkaline Other Phosphatase Increased Blood Bicarbonate Decreased Blood Bilirubin Increased Blood Calcium Increased Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Glucose Decreased Blood Magnesium Increased Blood Phosphorus Increased Blood Sodium Increased Blood Urea Increased Cognitive Disorder Diabetic Coma Difficulty In Walking Drug Level Below 24-Jun-2005 12:19 PM Page: 3143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Gamma-Glutamyltransferase Increased Haematocrit Decreased Report Source Product Role Manufacturer Route Dose Duration Mean Cell Haemoglobin Foreign Zyprexa Increased Consumer (Olanzapine) PS ORAL 7.5 MG AT Platelet Distribution Health BEDTIME Width Professional Lithium C Polyneuropathy Other Epival Protein Total Increased (Valproate Red Blood Cell Count Semisodium) C Decreased Anti-Inflammatory C Sciatica Allopurinol C Synthroid (Levothyroxine Sodium) C Date:10/13/04ISR Number: 4477599-2Report Type:Expedited (15-DaCompany Report #JP_040904608 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Foreign Zyprexa Initial or Prolonged Red Blood Cell Count Health (Olanzapine) PS ORAL 20 MG DAY Decreased Professional Dogmatyl White Blood Cell Count Company (Sulpiride) C Decreased Representative Senitan Other (Bromazepam) C Halcion (Triazolam) C Lac B (Lactobacillus Bifidus, Lyophilized) C Date:10/13/04ISR Number: 4477601-8Report Type:Expedited (15-DaCompany Report #JP_040904599 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Zyprexa Initial or Prolonged Health (Olanzapine) PS ORAL 5 MG DAY Professional Risperdal Company (Risperidone) C Representative Hydantol D C Other Neophyllin (Aminophylline) C Benzalin (Nitrazepam) C Tasmolin (Biperiden) C Date:10/13/04ISR Number: 4478319-8Report Type:Expedited (15-DaCompany Report #JP_040904404 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Aplastic Anaemia Foreign Initial or Prolonged Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 3144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 2.5 MG DAY Valproate Sodium C Date:10/13/04ISR Number: 4478321-6Report Type:Expedited (15-DaCompany Report #JP_041004648 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Representative Other Date:10/13/04ISR Number: 4478347-2Report Type:Expedited (15-DaCompany Report #EWC040940749 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG DAY 1 YR Company Impromen Decanoas Representative (Bromperidol Other Decanoate) C Temesta (Lorazepam) C Akineton (Biperiden Lactate) C Date:10/13/04ISR Number: 4478350-2Report Type:Expedited (15-DaCompany Report #FR_040904885 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa-Oral Initial or Prolonged Subcutaneous Abscess Health (Olanzapine) Other Professional (Olanzapine) PS 10 MG/3 DAY Other Halodol (Haloperidol Decanoate) C Zoloft (Sertraline Hydrochloride) C Date:10/13/04ISR Number: 4478351-4Report Type:Expedited (15-DaCompany Report #FR_040904858 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Foreign Zyprexa-Oral Initial or Prolonged Subileus Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG DAY Other Tercian (Cyamemazine) C Depakote (Valproate Semisodium) C Fluanxol 24-Jun-2005 12:19 PM Page: 3145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Flupentixol Decanoate) C Date:10/13/04ISR Number: 4478352-6Report Type:Expedited (15-DaCompany Report #FR_040904889 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Foreign Zyprexa-Oral Initial or Prolonged C-Reactive Protein Health (Olanzapine) Other Increased Professional (Olanzapine) PS 7.5 MG DAY Leukopenia Other Pyrexia Date:10/13/04ISR Number: 4478354-XReport Type:Expedited (15-DaCompany Report #FR_040904890 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Hypercapnia Health (Olanzapine) Lung Disorder Professional (Olanzapine) PS Malnutrition Other Xanax (Alprazolam Rales Dum) C Somnolence Mopral (Omeprazole Ratiopharm) C Effexor (Venlafaxine Hydrochloride) C Date:10/14/04ISR Number: 4477874-1Report Type:Expedited (15-DaCompany Report #2004CG01970 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Mopral PS NI Initial or Prolonged Hypercapnia Health Xanax SS NI Pneumonia Professional Effexor SS NI Somnolence Other Zyprexa SS NI Oxygen C Date:10/15/04ISR Number: 4476671-0Report Type:Direct Company Report #CTU 229734 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Zyprexa PS Lipase Increased Date:10/15/04ISR Number: 4479058-XReport Type:Expedited (15-DaCompany Report #JP_031202295 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Foreign Zyprexa-Oral Blepharospasm Literature (Olanzapine) Drug Ineffective Health (Olanzapine) PS 10 MG DAY Photophobia Professional Rivotril Company (Clonazepam) C Representative Other 24-Jun-2005 12:19 PM Page: 3146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/04ISR Number: 4479269-3Report Type:Expedited (15-DaCompany Report #2004235965US Age:26 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Xanax (Alprazolam) Intentional Misuse Health Tablet PS Professional Methadone (Methadone) SS Olanzapine (Olanzapine) SS Date:10/18/04ISR Number: 4479545-4Report Type:Expedited (15-DaCompany Report #2004071941 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Zoloft (Sertraline) PS 50 MG (1 IN 1 Hospitalization - Intentional Misuse Health D) Initial or Prolonged Pneumonitis Chemical Professional Olanzapine Other Suicide Attempt Company (Olanzapine) SS 30 MG (1 IN 1 Representative D) Bromazepam (Bromazepam) SS 2 MG (1 IN 1 D) Date:10/18/04ISR Number: 4479970-1Report Type:Expedited (15-DaCompany Report #DSA_24857_2004 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Wypax PS Initial or Prolonged Pregnancy Health Zyprexa SS Laboratory Test Abnormal Professional Neonatal Apnoeic Attack Other Date:10/18/04ISR Number: 4480069-9Report Type:Expedited (15-DaCompany Report #2004075607 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Consumer Zoloft (Sertraline) PS ORAL 50 MG (50 MG, Initial or Prolonged Living Impaired 1 IN 1 D), Blood Pressure Increased ORAL Dysphagia Neurontin Dyspnoea (Gabapentin) Heart Rate Irregular (Gabapentin) SS ORAL ORAL Immobile Olanzapine Prescribed Overdose (Olanzapine) SS ORAL ORAL Weight Decreased Tolterodine L-Tartrate (Tolterodine L-Tartrate) SS ORAL ORAL Rofecoxib (Rofecoxib) SS Atenolol (Atenolol) C Multivitamins (Ascorbic Acid/Ergocalciferol/ Folic Acid/Nicotinamide/Pa C Senna Fruit (Senna Fruit) C 24-Jun-2005 12:19 PM Page: 3147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Donepezil Hydrochloride (Donepezil Hydrochloride) C Hemorid For Women Cream (Aloe Vera, Paraffin, Liquid Phenylephrine Hydrochloride, C All Other Therapeutic Products C Date:10/18/04ISR Number: 4480377-1Report Type:Expedited (15-DaCompany Report #EWC041040887 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine-Oral Feeling Abnormal Health (Olanzapine) PS 10 MG Professional Other Date:10/20/04ISR Number: 4481929-5Report Type:Expedited (15-DaCompany Report #FR_041004931 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytolytic Hepatitis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG DAY Other Depakote (Valproate Semisodium) C Urbanyl (Clobazam) C Date:10/20/04ISR Number: 4481931-3Report Type:Expedited (15-DaCompany Report #GBS041015690 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa-Oral Hospitalization - Mental Disorder Health (Olanzapine) Initial or Prolonged Pulmonary Embolism Professional (Olanzapine) PS Weight Increased Other Date:10/20/04ISR Number: 4481933-7Report Type:Expedited (15-DaCompany Report #GBS041015685 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lipids Increased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 2 MON Company Representative Other 24-Jun-2005 12:19 PM Page: 3148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/04ISR Number: 4481934-9Report Type:Expedited (15-DaCompany Report #EWC041040964 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Zyprexa-Oral Initial or Prolonged Thrombosis Health (Olanzapine) Professional (Olanzapine) PS 5 MG/1 DAY Other Alprazolam C Date:10/20/04ISR Number: 4481941-6Report Type:Expedited (15-DaCompany Report #EWC041040948 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 20 MG DAY Drug Toxicity Professional Femur Fracture Company Injury Representative Leukocytosis Other Mucosal Dryness Neuroleptic Malignant Syndrome Post Procedural Complication Tremor Date:10/20/04ISR Number: 4481942-8Report Type:Expedited (15-DaCompany Report #FR_040904770 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Zyprexa-Oral Fracture Consumer (Olanzapine) Nausea Health (Olanzapine) PS 10 MG/1 DAY Upper Limb Fracture Professional Levotonine Other (Oxitriptan) C Nootropyl (Piracetam) C Rivotril (Clonazepam) C Date:10/20/04ISR Number: 4481944-1Report Type:Expedited (15-DaCompany Report #EWC041040959 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Fibrinogen Foreign Zyprexa-Oral Initial or Prolonged Increased Consumer (Olanzapine) Blood Potassium Decreased Health (Olanzapine) PS 10 MG/1 DAY Condition Aggravated Professional Maveral (Fluvoxamine Crohn'S Disease Other Maleate) C International Normalised Felison (Flurazepam Ratio Increased Hydrochloride) C Prothrombin Level Asacol (Mesalazine) C Increased Valium (Diazepam) C Respiratory Distress Schizophrenia 24-Jun-2005 12:19 PM Page: 3149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/04ISR Number: 4481945-3Report Type:Expedited (15-DaCompany Report #JP_040503182 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Zyprexa-Oral Initial or Prolonged Fall Study (Olanzapine) Other Femoral Neck Fracture Health (Olanzapine) PS 5 MG DAY Gastritis Erosive Professional Halosten Nausea Other (Haloperidol) C Oral Intake Reduced Vegetamin B C Persecutory Delusion Doral (Quazepam) C Vomiting Seroquel Quetiapine Fumarate) C Date:10/20/04ISR Number: 4481946-5Report Type:Expedited (15-DaCompany Report #JP_040904404 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa-Oral Initial or Prolonged Cholelithiasis Health (Olanzapine) Hepatic Steatosis Professional (Olanzapine) PS 5 MG DAY Mania Company Depakene-R(Valproate Pancytopenia Representative Sodium) C Purpura Other Rohypnol (Fluntrazepam Eg) C Amoban (Zopiclone) C Lithium C Date:10/20/04ISR Number: 4481948-9Report Type:Expedited (15-DaCompany Report #JP_040904591 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG DAY Aminotransferase Company Paxil (Paroxetine Increased Representative Hydrochloride) C Blood Alkaline Other Dogmatyl (Sulpiride) C Phosphatase Increased Lexotan (Bromazepam) C Gamma-Glutamyltransferase Levotomin Increased (Levomepromazine Hepatic Function Abnormal Maleate) C Rhythmy (Rilmazafone) C Date:10/20/04ISR Number: 4482002-2Report Type:Expedited (15-DaCompany Report #EWC040238190 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Olanzapine-Oral Cardiopulmonary Failure Study (Olanzapine) PS 5 MG/1 DAY Coma Health Artane Hypotension Professional (Trihexyphenidyl Other Hydrochloride) C Herbesser (Diltiazem Hydrochloride) C Renitec (Enalapril Maleate) C Diamicron 24-Jun-2005 12:19 PM Page: 3150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Gliclazide) C Date:10/20/04ISR Number: 4482040-XReport Type:Expedited (15-DaCompany Report #GBS040915659 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Zyprexa-Oral Completed Suicide Health (Olanzapine) Injury Asphyxiation Professional (Olanzapine) PS 15 MG DAY Other Depixol (Flupentixol Decanoate) C Date:10/20/04ISR Number: 4482043-5Report Type:Expedited (15-DaCompany Report #GBS040815454 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Olanzapine-Oral Dyspnoea Exertional Health (Olanzapine) PS 6 YR Ejection Fraction Professional Valproate Semisodium C Decreased Other Exercise Tolerance Decreased Palpitations Date:10/20/04ISR Number: 4482047-2Report Type:Expedited (15-DaCompany Report #FR_041004906 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicidal Ideation Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 30 MG DAY Company Tercian Representative (Cyamemazine) C Other Haldol Decanoate (Haloperidol Decanoate) C Date:10/20/04ISR Number: 4482050-2Report Type:Expedited (15-DaCompany Report #EWC040740022 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Olanzapine-Oral Anger Study (Olanzapine) PS 10 MG DAY Condition Aggravated Health Judgement Impaired Professional Negativism Other Psychotic Disorder Suicidal Ideation Tension Date:10/20/04ISR Number: 4482097-6Report Type:Expedited (15-DaCompany Report #USA040876608 Age:19 YR Gender:Female I/FU:F Outcome PT Other Dizziness Loss Of Consciousness Oral Intake Reduced 24-Jun-2005 12:19 PM Page: 3151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tunnel Vision Report Source Product Role Manufacturer Route Dose Duration Health Symbyax-Olanzapine 6 Professional Mg / Fluoxetine 25 Company Mg (Olanzapin PS 2 WK Representative Date:10/20/04ISR Number: 4482121-0Report Type:Expedited (15-DaCompany Report #USA041080199 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Symbyax-Olanzapine Initial or Prolonged Oedema Peripheral Professional 6mg / Fluoxetine Other Company 25mg (Olanzapin PS Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Date:10/20/04ISR Number: 4482124-6Report Type:Expedited (15-DaCompany Report #USA041080299 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Health Symbyax-Olanzapine Circulatory Collapse Professional 6mg / Fluoxetine Dizziness Company 25mg (Olanzapin PS 8 DAY Oesophageal Disorder Representative Palpitations Transient Ischaemic Attack Date:10/20/04ISR Number: 4482127-1Report Type:Expedited (15-DaCompany Report #USA041080394 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Symbyax-Olanzapine Other Antidepressant Drug Level Professional 6mg / Fluoxetine Increased Company 25mg(Olanzapin PS Road Traffic Accident Representative Date:10/20/04ISR Number: 4482131-3Report Type:Expedited (15-DaCompany Report #US_0408104538 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Confusional State Professional (Olanzapine) Diabetes Mellitus Other (Olanzapine) PS 20 MG DAY Diabetic Gastroparesis Fluvoxamine Maleate C Disorientation Glucophage Enuresis (Metformin) C Fatigue Starlix Food Craving (Nateglinide) C Irritability Plavix (Clopidogrel Mental Status Changes Sulfate) C Thirst Reglan (Metoclopramide 24-Jun-2005 12:19 PM Page: 3152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Seroquel (Quetiapine Fumarate) C Date:10/20/04ISR Number: 4482147-7Report Type:Expedited (15-DaCompany Report #USA041079903 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Symbyax-Olanzapine Loss Of Consciousness Professional 6mg / Fluoxetine Road Traffic Accident Company 25mg (Olanzapin PS Representative Strattera (Atomoxetine Hydrochloride) SS 25 MG/1 DAY Doxycycline C Date:10/20/04ISR Number: 4482162-3Report Type:Expedited (15-DaCompany Report #USA041080230 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Paxil (Paroxetine Hydrochloride) C Date:10/20/04ISR Number: 4482237-9Report Type:Expedited (15-DaCompany Report #JP_041004698 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Hypersensitivity Foreign Zyprexa-Oral Hospitalization - Photosensitivity Reaction Health (Olanzapine) Initial or Prolonged Skin Test Positive Professional (Olanzapine) PS Other Depakene (Valproate Sodium) C Limas (Lithium Carbonate) C Date:10/20/04ISR Number: 4482240-9Report Type:Expedited (15-DaCompany Report #US_0410106418 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Olanzapine-Oral Initial or Prolonged Psychotic Disorder Health (Olanzapine) PS 7.5 MG/1 DAY Professional Company Representative Other Date:10/20/04ISR Number: 4482243-4Report Type:Expedited (15-DaCompany Report #GBS041015697 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Olanzapine-Oral Initial or Prolonged Pulmonary Embolism Health (Olanzapine) PS 20 MG Professional Amitriptyline C Other Zopiclone 24-Jun-2005 12:19 PM Page: 3153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zopiclone) C Date:10/20/04ISR Number: 4482251-3Report Type:Expedited (15-DaCompany Report #EWC041040925 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vasospasm Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 10 MG Professional Other Date:10/20/04ISR Number: 4482285-9Report Type:Expedited (15-DaCompany Report #US_0410106356 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polytraumatism Consumer Zyprexa -Oral (Olanzapine) PS Date:10/20/04ISR Number: 4482286-0Report Type:Expedited (15-DaCompany Report #US_0408104879 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Consumer Zyprexa-Oral Initial or Prolonged Decreased Health (Olanzapine) PS 15 MG AT Blood Pressure Systolic Professional BEDTIME Increased Zestril (Lisinopril) C Diabetes Mellitus Celexa (Citalopram Headache Hydrobromide) C Upper Respiratory Tract 'Thimox' C Infection Celebrex (Celecoxib) C Vision Blurred Singulair Weight Increased (Montelukast) C (Esomeprazole Magnesium) C 'Becusate' C Senokot (Senna Alexandrina) C Trazadone C Zyrtec (Cetirizine Hydrochloride) C Hydrochlorothiazide C Atrovent (Ipratropium Bromide) C Potassium C Vitamin C C Vitamin E (Herbal Oil Nos) C Date:10/20/04ISR Number: 4482287-2Report Type:Expedited (15-DaCompany Report #USA041080471 Age:27 YR Gender:Male I/FU:I Outcome PT Death Asthenia Other Feeling Abnormal Prescribed Overdose Tongue Disorder Tremor 24-Jun-2005 12:19 PM Page: 3154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa -Oral (Olanzapine) PS Klonopin (Clonazepam) C Buspar (Buspirone Hydrochloride) C Neurontin (Gabapentin Pfizer) C Date:10/20/04ISR Number: 4482290-2Report Type:Expedited (15-DaCompany Report #USA041080347 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Zyprexa-Oral Convulsion (Olanzapine) PS 20 MG/1 DAY Depression Xanax (Alprazolam Drug Effect Decreased Dum) C Hunger Buspar (Buspirone Road Traffic Accident Hydrochloride) C Weight Increased Paxil (Aproxetine Hydrochloride) C Methadone C Date:10/20/04ISR Number: 4482674-2Report Type:Expedited (15-DaCompany Report #USA041080355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Health Zyprexa-Oral Consciousness Professional (Olanzapine) Drug Interaction (Olanzapine) PS 2.5 MG/2 DAY Lethargy Tylenol Pm C Furosemide (Furosemide) C Pravachol (Pravastatin Sodium) C Date:10/20/04ISR Number: 4482675-4Report Type:Expedited (15-DaCompany Report #USA041080268 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) Company (Olanzapine) PS Representative Date:10/20/04ISR Number: 4483355-1Report Type:Expedited (15-DaCompany Report #EWC040940470 Age:59 YR Gender:Male I/FU:F Outcome PT Death Aggression Hospitalization - Agitation Initial or Prolonged Atherosclerosis Bladder Discomfort Bundle Branch Block Left 24-Jun-2005 12:19 PM Page: 3155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Cardiomegaly Cardiomyopathy Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Olanzapine-Rapid-Act Constipation Study ing Im PS INTRAMUSCULAR 30 MG DAY Fall Health Cardura (Doxazosin) C Flatulence Professional Clopixol Depot Gastrointestinal Pain Other (Zuclopenthixol Hypertension Decanoate) C Myocardial Ischaemia Tisercin Psychotic Disorder (Levomepromazine) C Pulmonary Artery Thrombosis Pulmonary Embolism Renal Disorder Respiratory Arrest Tachycardia Therapy Non-Responder Tremor Urinary Retention Ventricular Dysfunction Date:10/20/04ISR Number: 4483377-0Report Type:Expedited (15-DaCompany Report #AU_041008083 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa-Roal Blood Prolactin Increased Health (Olanzapine) Cerebrovascular Accident Professional (Olanzapine) PS 5 MG/ 1 DAY Company Zantac (Ranitidine Representative Hydrochloride) C Other Caltrate (Calcium Carbonate) C Lisinopril (Lisinopril) C Lasix (Furosemide) C Diclofenac C Timolol C Date:10/20/04ISR Number: 4484047-5Report Type:Expedited (15-DaCompany Report #2004AL000827 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Children'S Apap Multiple Drug Overdose Elixir (Acetaminophen) (Alpharma) PS Alpharma ORAL PO Infant'S' Apap Drops (Acetaminophen) (Alpharma) SS Alpharma ORAL PO Olanzapine SS ORAL PO Date:10/21/04ISR Number: 4483579-3Report Type:Expedited (15-DaCompany Report #2004AL000892 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Children'S Apap Multiple Drug Overdose Elixir 24-Jun-2005 12:19 PM Page: 3156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetaminophen) (Alpharma) PS Alpharma ORAL PO Infants' Apap Drops (Acetaminophen) (Alpharma) SS Alpharma ORAL PO Olanzapine SS ORAL PO Date:10/21/04ISR Number: 4483672-5Report Type:Expedited (15-DaCompany Report #2004AL001032 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Children'S Apap Intentional Misuse Elixir (Acetaminophen) (Alpharma) PS Alpharma ORAL PO Infants' Apap Drops (Acetaminophen) (Alpharma) SS Alpharma ORAL PO Aspirin SS ORAL PO Olanzapine SS ORAL PO Date:10/21/04ISR Number: 4483956-0Report Type:Expedited (15-DaCompany Report #USA040978509 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Health Zyprexa-Oral Abdominal Rebound Professional (Olanzapine) Tenderness (Olanzapine) PS Blood Urine Present Strattera (Atomoxetine Hydrochloride) SS Date:10/21/04ISR Number: 4484322-4Report Type:Expedited (15-DaCompany Report #2004AL000830 Age:67 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Literature Chlorpromazine Multiple Drug Overdose Hydrochloride PS Alpharma ORAL PO Olanzapine SS ORAL PO Date:10/21/04ISR Number: 4484445-XReport Type:Expedited (15-DaCompany Report #2004AL000891 Age:58 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Children'S Apap Multiple Drug Overdose Elixir (Acetaminophen) (Alpharma) PS Alpharma ORAL PO Infants' Apap Drops (Acetaminophen) (Alpharma) SS Alpharma ORAL PO Olanzapine SS ORAL PO Buspirone SS ORAL PO 24-Jun-2005 12:19 PM Page: 3157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/04ISR Number: 4486704-3Report Type:Expedited (15-DaCompany Report #DE_040914270 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Oral Cerebral Infarction Consumer (Olanzapine) Health (Olanzapine) PS 15 MG DAY Professional Sortis (Atorvastatin Company Calcium) C Representative Other Date:10/21/04ISR Number: 4486734-1Report Type:Expedited (15-DaCompany Report #S04-GER-02020-01 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Seroplex Initial or Prolonged Atrioventricular Block Health (Escitalopram) PS ORAL 480 MG ONCE Disability Blood Pressure Systolic Professional PO Other Increased Other Seroplex Bradycardia (Escitalopram) SS ORAL 15 MG QD PO Bradypnoea Zyprexa (Olanazpine) SS ORAL 67 TABLET Coma ONCE PO Cyanosis Zyprexa (Olanzapine) SS Electrocardiogram Qt Quitaxon (Doxepin Prolonged Hydrochloride) SS ORAL 20 TABLET Heart Rate Increased ONCE PO Hypotension Quitaxon (Doxepin Impulsive Behaviour Hydrochloride) SS ORAL 10 MG TID PO Intentional Misuse Rivotril Major Depression (Clonazepam) C Malaise Pallor Suicide Attempt Syncope Vasovagal Tongue Disorder Tremor Vertigo Date:10/22/04ISR Number: 4481983-0Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0271841-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Depakote PS ORAL 19 DAY Initial or Prolonged Blood Creatine Olanzapine SS ORAL 32 DAY Phosphokinase Mb Olanzapine SS UNKNOWN 32 DAY Increased Prazepam C ORAL Cogwheel Rigidity Levothyroxine Sodium C ORAL Fall Estradiol C ORAL Gait Deviation Promegestone C ORAL Gait Disturbance Hypotonia Neuroleptic Malignant Syndrome Tremor Unevaluable Event Urinary Tract Infection 24-Jun-2005 12:19 PM Page: 3158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/04ISR Number: 4482470-6Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0347536A Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Paxil PS Glaxosmithkline ORAL Initial or Prolonged Hyperhidrosis Zyprexa SS ORAL 5 DAY Pyrexia Amlodin C ORAL 5MG per day Restlessness Maglax C ORAL 990MG per day Serotonin Syndrome Pantosin C ORAL 1200MG per Tension day Tremor Depas C ORAL 1MG per day Date:10/22/04ISR Number: 4484771-4Report Type:Expedited (15-DaCompany Report #2004AL000535 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Alprazolam Tablets Drug Abuser Usp, 2mg (Purepac) PS Purepac ORAL PO Multiple Drug Overdose Methadone SS ORAL PO Olanzapine SS Date:10/22/04ISR Number: 4485292-5Report Type:Direct Company Report #CTU 230320E Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Olanzapine 5 Mg Eli Initial or Prolonged Lilly PS Eli Lilly ORAL 5 MG QAM ORAL Date:10/22/04ISR Number: 4485541-3Report Type:Expedited (15-DaCompany Report #2004AL000831 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Clonazepam Tablets Completed Suicide Usp, 0.5mg, 1mg, And Intentional Misuse 2mg (Purepac) PS Purepac ORAL PO Olanzaprine SS ORAL PO Ziprasidone SS ORAL PO Date:10/22/04ISR Number: 4488113-XReport Type:Expedited (15-DaCompany Report #GBWYE117918OCT04 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Effexor (Venlafaxine Neuroleptic Malignant Professional Hydrochloride, Syndrome Tablet, 0) PS Olazapine (Olanzapine) SS Date:10/25/04ISR Number: 4487832-9Report Type:Expedited (15-DaCompany Report #S04-CAN-07034-01 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Celexa (Citalopram Consciousness Health Hydrobromide) PS ORAL 40 MG QD PO Opisthotonus Professional Aricept (Donepezil Other Hydrochloride) SS ORAL 10 MG QD PO Seroquel (Quetiapine 24-Jun-2005 12:19 PM Page: 3159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fumarate) SS ORAL 25 MG QD PO Zyprexa (Olanzapine) SS ORAL 3.75 MG QD PO Phenytoin SS ORAL 300 MG QD PO Acetaminophen C Crestor (Rosuvastatin) C Asa (Acetylsalicylic Acid) C Senna C Multivitamins C Date:10/25/04ISR Number: 4489958-2Report Type:Expedited (15-DaCompany Report #2004075607 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Consumer Zoloft (Sertraline) PS ORAL 50 MG (50 MG Initial or Prolonged Living Impaired , 1 IN 1 D), Other Aphagia ORAL Blood Pressure Increased Neurontin Dysphagia (Gabapentin) SS ORAL ORAL Dyspnoea Olanzapine Mobility Decreased (Olanzapine) SS ORAL ORAL Pulse Abnormal Tolterodine Unevaluable Event L-Tartrate Weight Decreased (Tolterodine L-Tartrate) SS ORAL ORAL Rofecoxib (Rofecoxib) SS Atenolol (Atenolol) C Multivitamins (Ascorbic Acid, Ergocalciferol, Folic Acid, Nicotinamide, C Senna Fruit (Senna Fruit) C Donepezil Hydrochloride (Donepezil Hydrochloride) C All Other Therapeutic Products (All Other Therapeutic Products) C Hemorid For Women Cream (Aloe Vera, Paraffin, Liquid, Phenylephrine Hydrochloride, C Date:10/25/04ISR Number: 4520232-1Report Type:Periodic Company Report #USA040875123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Zyprexa-Oral Initial or Prolonged Mania Professional (Olanzapine) Oedema Company (Olanzapine) PS 15 MG DAY Representative Symbax-Olanzapine / Fluoxetine (Unknown 24-Jun-2005 12:19 PM Page: 3160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose) (Ola SS Date:10/25/04ISR Number: 4520234-5Report Type:Periodic Company Report #USA040874403 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg/ Fluoxetine 25mg Other Company (Olanzapin PS Representative Zocor (Simvastatin) C Glyburide C Multivitamin C Fiorinal C Date:10/25/04ISR Number: 4520238-2Report Type:Periodic Company Report #USA040772576 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Symbyax-Olanzapine / Initial or Prolonged Professional Fluoxetine (Ola PS Company Representative Date:10/25/04ISR Number: 4520241-2Report Type:Periodic Company Report #USA040771957 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg / Fluoxetien Company 25mg (Olanzapin PS Representative Date:10/25/04ISR Number: 4520242-4Report Type:Periodic Company Report #USA040567581 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg / Fluoxetine Other Company 25mg (Olanzapin PS Representative Date:10/25/04ISR Number: 4520244-8Report Type:Periodic Company Report #USA040978997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/1 DAY Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/04ISR Number: 4520246-1Report Type:Periodic Company Report #USA040978500 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Symbyax-Olanzapine / Professional Fluoxetine (Ola PS Company Representative Date:10/25/04ISR Number: 4520248-5Report Type:Periodic Company Report #USA040978594 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Health Symbyax-Olanzapine Initial or Prolonged Pancreatitis Professional 12mg / Fluoxetine Other Company 50mg (Olanzapi PS Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Wellbutrin (Bupropion Hydrochloride) C Topamax (Topiramate) C Buspar (Buspirone Hydrochloride) C Depakote (Valproate Semisodium) C Date:10/25/04ISR Number: 4520253-9Report Type:Periodic Company Report #USA040978710 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Symbyax-Olanzapine Initial or Prolonged Professional 12mg / Fluoxetine Other Company 25mg (Olanzapi PS Representative Date:10/25/04ISR Number: 4520255-2Report Type:Periodic Company Report #USA040877002 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Symbyax-Olanzapine Initial or Prolonged Somnolence Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Date:10/25/04ISR Number: 4520256-4Report Type:Periodic Company Report #USA040977101 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Symbyax-Olanzapine 6mg / Flyoxetine 25mg (Olanzapin SS 24-Jun-2005 12:19 PM Page: 3162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/04ISR Number: 4520258-8Report Type:Periodic Company Report #USA040978161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Ativan(Lorazepam) C Date:10/25/04ISR Number: 4520261-8Report Type:Periodic Company Report #USA040876723 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Symbyax-Olanzapine Initial or Prolonged Anxiety Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Alprazolam C Date:10/25/04ISR Number: 4520264-3Report Type:Periodic Company Report #USA040876193 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Klonopin (Clonazepam) C Xanax (Alprazolam Dum) C Trazodone (Trazodone) C Date:10/25/04ISR Number: 4520265-5Report Type:Periodic Company Report #USA040874979 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Symbyax-Olanzapine Initial or Prolonged Suicide Attempt Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS Flonase (Fluticasone Propionate) C Allegra-D C Date:10/26/04ISR Number: 4485715-1Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0347536A Age:72 YR Gender:Female I/FU:F Outcome PT Hospitalization - Delirium Initial or Prolonged Diarrhoea Hyperhidrosis Myoclonus Pyrexia Restlessness Serotonin Syndrome Tension 24-Jun-2005 12:19 PM Page: 3163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Paxil PS Glaxosmithkline ORAL Zyprexa SS ORAL 5 DAY Amlodin C ORAL 5MG per day Maglax C ORAL 990MG per day Pantosin C ORAL 1200MG per day Depas C ORAL 1MG per day Date:10/26/04ISR Number: 4487879-2Report Type:Expedited (15-DaCompany Report #USA040671281 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Effect Consumer Zyprexa Zydis (Olanzapine) PS 15 MG AT BEDTIME Trazodone C Celexa (Citalopram Hydrobromide) C Mellaril (Thioridazine Hydrochloride) C Date:10/26/04ISR Number: 4487881-0Report Type:Expedited (15-DaCompany Report #US_0408104540 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anoxia Initial or Prolonged Balance Disorder Other Blood Pressure Increased Bowel Sounds Abnormal Bronchitis Cardiac Neoplasm Unspecified Catheter Related Complication Cerebral Disorder Cholecystectomy Coma Dehydration Diabetes Mellitus Non-Insulin-Dependent Diabetic Ketoacidosis Disseminated Intravascular Coagulation Dry Mouth Electrocardiogram St Segment Depression Hypertension Hypoglycaemia Hypotension Hypovolaemia Impaired Gastric Emptying Injury Lactic Acidosis Low Density Lipoprotein Increased 24-Jun-2005 12:19 PM Page: 3164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Menopausal Symptoms Menorrhagia Metabolic Acidosis Report Source Product Role Manufacturer Route Dose Duration Otitis Media Consumer Zyprexa Overdose Health (Olanzapine) PS ORAL 15 MG/1 AT Pancreatic Cyst Professional BEDTIME Pancreatitis Humulin-Human Pharyngitis Insulin (Rdna) Pollakiuria :30% Regular, 70% Renal Failure Acute Nph (H SS 110 U DAY Respiratory Failure Lithium C Rhabdomyolysis Prilosec Sepsis (Omeprazole) C Shock Levothyroid Sinobronchitis (Levothyroxine Sinus Tachycardia Sodium) C Sinusitis Avapro(Irbesartan) C Therapeutic Agent Iron Supplement C Toxicity Paxil (Proxetine Thirst Hydrochloride) C Ulcer Lotensin (Benazepril Weight Decreased Hydrochloride) C Weight Increased Desogestrel W/Ethinylestradiol C Buspar (Buspirone Hydrochloride) C Sarafem(Fluoxetine) C Effexor (Venlafaxine Hydrochloride) C Multivitamin C Date:10/26/04ISR Number: 4487918-9Report Type:Expedited (15-DaCompany Report #USA041080465 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Strattera Initial or Prolonged Intestinal Obstruction Professional (Atomoxtine Company Hydrochloride) PS 60 MG/1 DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/1 DAY Buspar (Buspirone Hydrochloride) C Clonidine C Ritalin (Methylphenidate Hydrochloride) C Date:10/26/04ISR Number: 4487938-4Report Type:Expedited (15-DaCompany Report #USA041080573 Age:50 YR Gender:Male I/FU:I Outcome PT Other Depression Diabetes Mellitus Mania 24-Jun-2005 12:19 PM Page: 3165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Renal Failure Stress Report Source Product Role Manufacturer Route Dose Duration Treatment Noncompliance Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 50 MG Lithium C Depakote (Valproate Semisodium) C Lasix (Furosemide) C Atenolol C Clonopin (Clonazepam) C Baycol (Cerivastatin Sodium) C Vioxx (Rofecoxib) C Mellaril (Thioridazine Hydrochloride) C Date:10/26/04ISR Number: 4487941-4Report Type:Expedited (15-DaCompany Report #USA030536319 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa-Oral Initial or Prolonged Blood Creatine Professional (Olanzapine) Phosphokinase Increased (Olanzapine) PS 30 MG/DAY Chronic Obstructive Artane Airways Disease (Trihexyphenidyl Exacerbated Hydrochloride) C Fall Date:10/26/04ISR Number: 4487944-XReport Type:Expedited (15-DaCompany Report #USA040874173 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Other Feeling Of Despair Professional 12 Mg / Fluoxetine Treatment Noncompliance Company 50mg (Olanzapine PS Representative Lithium C Date:10/26/04ISR Number: 4488651-XReport Type:Expedited (15-DaCompany Report #USA041080993 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-0ral Initial or Prolonged Dizziness (Olanzapine) Other Drooling (Olanzapine) PS Dry Mouth Prozac (Fluoxetine Road Traffic Accident Hydrochloride) C Weight Increased 24-Jun-2005 12:19 PM Page: 3166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/04ISR Number: 4488652-1Report Type:Expedited (15-DaCompany Report #US_0410106706 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Diabetic Coma (Olanzapine) Diabetic Ketoacidosis (Olanzapine) PS Hyperglycaemia Pancreatitis Date:10/26/04ISR Number: 4488666-1Report Type:Expedited (15-DaCompany Report #USA041080456 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Date:10/26/04ISR Number: 4489020-9Report Type:Expedited (15-DaCompany Report #AU_041008101 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Foreign Zyprexa-Oral Pregnancy Health (Olanzapine) Polydactyly Professional (Olanzapine) PS 40 WK Company Representative Other Date:10/26/04ISR Number: 4489026-XReport Type:Expedited (15-DaCompany Report #AU_041008108 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Foreign Olanzapine-Oral Inappropriate Health (Olanzapine) PS Antidiuretic Hormone Professional Secretion Other Date:10/26/04ISR Number: 4489027-1Report Type:Expedited (15-DaCompany Report #CA_041007323 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Foreign Zyprexa-Oral Initial or Prolonged Dementia Consumer (Olanzapine) Dysarthria Other (Olanzapine) PS 7.5 MG AT Hypersomnia BEDTIME Memory Impairment Haldol(Haloperidol Decanoate) C Serax(Oxazepam) C Date:10/26/04ISR Number: 4489441-4Report Type:Expedited (15-DaCompany Report #EWC040940689 Age:24 YR Gender:Male I/FU:F Outcome PT Other Body Temperature Increased 24-Jun-2005 12:19 PM Page: 3167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bradycardia Circulatory Collapse Dehydration Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Foreign Zyprexa-Rapid-Acting Fall Health Im (Olanzapine) PS 10 MG Hypotension Professional Loss Of Consciousness Company Narcotic Intoxication Representative Poisoning Skin Laceration Date:10/26/04ISR Number: 4489448-7Report Type:Expedited (15-DaCompany Report #EWC041040999 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Foreign Zyprexa-Oral Increased Health (Olanzapine) PS 10 MG DAY Hepatomegaly Professional Hypertriglyceridaemia Other Multi-Organ Failure Oedema Pancreatic Disorder Pancreatitis Acute Respiratory Failure Systemic Inflammatory Response Syndrome Date:10/26/04ISR Number: 4489451-7Report Type:Expedited (15-DaCompany Report #EWC041040924 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 30 MG DAY Aspartate Professional Becozym C Aminotransferase Other Benerva (Thiamine Increased Hydrochloride) C Blood Cholesterol Folviet (Folic Acid) C Increased Risperdal Gamma-Glutamyltransferase (Risperidone) C Increased Liver Disorder Weight Increased Date:10/26/04ISR Number: 4489453-0Report Type:Expedited (15-DaCompany Report #EWC041040922 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Olanzapine-Oral Eyelid Oedema Health (Olanzapine) PS 17.5 MG DAY Face Oedema Professional Temesta (Lorazepam) C Monocytosis Other Risperidal Viral Infection (Risperidone) C Seropram (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 3168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/04ISR Number: 4489455-4Report Type:Expedited (15-DaCompany Report #EWC041041000 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Foreign Zyprexa-Oral Hospitalization - Intentional Misuse Health (Olanzapine) PS 1700 MG Initial or Prolonged Loss Of Consciousness Professional Fluoxetine-Oral Metabolic Acidosis Company (Fluoxetine) Suicide Attempt Representative (Fluoxetine Other Hydrochlor SS 1120 MG Topamax (Topiramate) C Date:10/26/04ISR Number: 4489581-XReport Type:Expedited (15-DaCompany Report #EWC041040966 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fluid Imbalance Foreign Zyprexa-Oral Initial or Prolonged Liver Function Test Other (Olanzapine) Abnormal (Olanzapine) PS 5 MG Malnutrition Temesta (Lorazepam) C Respiratory Failure Isoptin (Verapamil Hydrochloride) C Pantoloc (Pantoprazole Sodium) C Kalioral C Neurontin Forte C Date:10/26/04ISR Number: 4489588-2Report Type:Expedited (15-DaCompany Report #FR_040904784 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Company Depamide Representative (Valpromide) C Anafranil (Clomipramine Hydrochloride) C Glucophage (Metformin) C Diamicron (Gliclazide) C Date:10/26/04ISR Number: 4489591-2Report Type:Expedited (15-DaCompany Report #EWC041040959 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa-Oral Initial or Prolonged Blood Potassium Decreased Consumer (Olanzapine) Condition Aggravated Health (Olanzapine) PS 10 MG/1 DAY Crohn'S Disease Professional Maveral (Fluvoxamine International Normalised Other Maleate) C Ratio Increased Felison (Flurazepam Prothrombin Time Hydrochloride) C Prolonged Asacol (Mesalazine) C Respiratory Disorder Valium (Diazepam) C Schizophrenia 24-Jun-2005 12:19 PM Page: 3169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/04ISR Number: 4489592-4Report Type:Expedited (15-DaCompany Report #JP_040603281 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Zyprexa-Oral Hospitalization - Increased Health (Olanzapine) Initial or Prolonged Blood Urea Increased Professional (Olanzapine) PS 5 MG DAY Chemical Injury Company Meilax (Ethyl Condition Aggravated Representative Loflazepate) C Convulsion Benzalin Depressed Level Of (Nitrazepam) C Consciousness Haemodialysis Hepatitis B Hyponatraemia Intentional Self-Injury Polydipsia Rhabdomyolysis Suicide Attempt Water Intoxication Date:10/26/04ISR Number: 4489614-0Report Type:Expedited (15-DaCompany Report #EWC041040964 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Pulmonary Embolism Health (Olanzapine) Professional (Olanzapine) PS 5 MG/1 DAY Other Alprazolam C Date:10/27/04ISR Number: 4486411-7Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-04P-062-0277956-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Akineton PS ORAL Initial or Prolonged Suicide Attempt Lorazepam SS ORAL Doxepin SS ORAL Olanzapine SS ORAL Buspirone Hydrochloride SS ORAL Fluphenazine Hydrochloride SS ORAL Carbamazepine SS ORAL Date:10/27/04ISR Number: 4486415-4Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0271841-00 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Akinesia Initial or Prolonged Balance Disorder Blood Creatine Phosphokinase Mb Increased Cogwheel Rigidity Fall Gait Deviation Gait Disturbance Hypotonia Neuroleptic Malignant 24-Jun-2005 12:19 PM Page: 3170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Tremor Unevaluable Event Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Depakote PS ORAL 19 DAY Olanzapine SS ORAL 32 DAY Olanzapine SS UNKNOWN 32 DAY Prazepam C ORAL Levothyroxine Sodium C ORAL Estradiol C ORAL Promegestone C ORAL Mepronizine C ORAL Date:10/27/04ISR Number: 4490196-8Report Type:Expedited (15-DaCompany Report #2004079238 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Geodon (Ziprasidone) PS Professional Olanzapine Company (Olanzapine) SS Representative Drug Unspecified SS Date:10/27/04ISR Number: 4490553-XReport Type:Expedited (15-DaCompany Report #HQWYE726612OCT04 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Efexor Er Initial or Prolonged Pain In Extremity Professional (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL SEE IMAGE 26 DAY Efexor Er (Venlafaxine Hydrochloride, Tablet) SS ORAL 37.5 MG 1X PER 1 DAY; ORAL 4 DAY Zyprexa (Olanzapine, ) SS ORAL SEE IMAGE 32 DAY Valium (Diazepam C Olfen (Diclofenac Sodium) C Date:10/28/04ISR Number: 4488101-3Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045023A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Quilonum Retard PS Glaxosmithkline ORAL 675MG per day 181 DAY Initial or Prolonged Parkinsonism Professional Cipramil SS ORAL 80MG per day 7 MON Zyprexa SS ORAL 2.5MG per day Dociton C ORAL 10MG per day Euthyrox C Glaxosmithkline UNKNOWN 100UG per day 24-Jun-2005 12:19 PM Page: 3171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/04ISR Number: 4488148-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741450 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Aripiprazole PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Paroxetine SS ORAL Olanzapine SS ORAL Date:10/28/04ISR Number: 4491824-3Report Type:Direct Company Report #CTU 230723 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Symbyax PS ORAL ONE DAILY Intervention to Alcohol Use ORAL Prevent Permanent Confusional State Prozac 40 Mg SS ORAL ONE DAILY Impairment/Damage Dysphonia ORAL Imprisonment Legal Problem Memory Impairment Musculoskeletal Stiffness Speech Disorder Date:10/29/04ISR Number: 4534120-8Report Type:Direct Company Report #USP 56911 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Pfizer TABLET Zyprexa SS Lilly TABLET Date:11/01/04ISR Number: 4491761-4Report Type:Expedited (15-DaCompany Report #2003035058 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Acute Sinusitis Initial or Prolonged Aggression Disability Albumin Globulin Ratio Other Decreased Anaemia Anorexia Arthralgia Asthma Band Neutrophil Count Decreased Band Neutrophil Count Increased Blood Albumin Decreased Blood Calcium Decreased Blood Glucose Increased Blood Sodium Decreased Candidiasis Cellulitis Chills Dehydration Depression Dermatitis Exfoliative Disorientation Eczema Weeping 24-Jun-2005 12:19 PM Page: 3172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Excoriation Eye Pain Fungal Infection Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Zithromax (Caps) Herpes Virus Infection (Azithromycin) PS ORAL 1 IN 1 D, Hypersensitivity ORAL Insomnia Carbamazepine Leukocytoclastic (Carbamazepine) SS ORAL 400 MG (200 Vasculitis MG, 2 IN 1 Malaise D), ORAL Migraine Olanzapine Mood Swings (Olanzapine) SS ORAL 5 MG (1 IN 1 Nasopharyngitis D), ORAL Oedema Peripheral Venlafaxine Onychomadesis Hydrochloride Otitis Media (Venlafaxine Pain Hydrochloride) C Pharyngolaryngeal Pain Photosensitivity Reaction Protein Total Decreased Psychosomatic Disease Purulent Discharge Respiratory Tract Congestion Rhinitis Rhinitis Allergic Scratch Skin Tightness Skin Ulcer Stevens-Johnson Syndrome Swollen Tongue Toxic Epidermal Necrolysis Upper Gastrointestinal Haemorrhage Urticaria Vision Blurred Weight Decreased White Blood Cell Count Increased Date:11/01/04ISR Number: 4492088-7Report Type:Expedited (15-DaCompany Report #2004067358 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zoloft(Sertraline) PS 100 MG (1 IN1 Disability Bipolar Ii Disorder Professional D) 1 YR Depression Escitalopram Feelings Of Worthlessness (Escitalopram) SS 10 MG (10 MG, Irritability 1 IN 1 D) 1 MON Panic Attack Valproate Semisodium Paranoia (Valproate Psychotic Disorder Semisodium) SS Sleep Disorder Olanzapine Speech Disorder (Olanzapine) SS Stress Topiramate Suicidal Ideation (Topiramate) SS 50 MG Weight Increased Quetiapine Fumarate (Quetiapine Fumarate) SS 50 MG 24-Jun-2005 12:19 PM Page: 3173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4493299-7Report Type:Expedited (15-DaCompany Report #USA040773147 Age:7 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Strattera(Atomoxetin Condition Aggravated Professional e Hydrochloride) PS 25 MG DAY Headache Zyprexa-Oral Impulsive Behaviour (Olanzapine) Mydriasis (Olanzapine) SS 5 MG DAY Ophthalmological Metadate Cd Examination Abnormal (Methylphenidate Optic Atrophy Hydrochloride) C Photophobia Ddavp (Desmopressin Psychomotor Hyperactivity Acetate) C Tardive Dyskinesia Visual Field Defect Date:11/02/04ISR Number: 4493300-0Report Type:Expedited (15-DaCompany Report #USA040874173 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Other Treatment Noncompliance Professional 12mg / Fluoxetine Company 50mg (Olanzapi PS Representative Lithium C Date:11/02/04ISR Number: 4493927-6Report Type:Expedited (15-DaCompany Report #USA040466258 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Caesarean Section Health Zyprexa Drug Exposure During Professional Pregnancy Company (Olanzapine) PS ORAL 10 MG/1 DAY Gestational Diabetes Representative Nortriptyline C Pre-Eclampsia Lexapro Pregnancy (Escitalopram Premature Baby Oxalate) C Weight Increased Date:11/02/04ISR Number: 4494080-5Report Type:Expedited (15-DaCompany Report #US_0410107094 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Zyprexa-Oral Neutropenia Professional (Olanzapine) (Olanzapine) PS 10 MG/1 DAY Haldol (Haloperidol Decanoate) C Gabapentin C Date:11/02/04ISR Number: 4494081-7Report Type:Expedited (15-DaCompany Report #US_0410107180 Age:51 YR Gender:Female I/FU:I Outcome PT Other Arthritis Basal Cell Carcinoma Blister Blood Cholesterol 24-Jun-2005 12:19 PM Page: 3174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Blood Triglycerides Increased Condition Aggravated Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa-Oral Diarrhoea (Olanzapine) Dysphagia (Olanzapine) PS 15 MG/2 DAY Gastrointestinal Pain Paxil (Paroxetine Gastrooesophageal Reflux Hydrochloride) C Disease Celebrex (Celecoxib) C Glaucoma Premarin C Glycosuria Zantac (Ranitidine Hyperglycaemia Hydrochloride) C Hyperphagia Bextra (Valdecoxib) C Hypertension Potassium C Hypoglycaemia Erythromycin Irritability (Erythromycin) C Obesity Timolol C Oedema Lotrisone C Polydipsia Xenical (Orlistat) C Polyuria Lasix (Furosemide) C Pyrexia Famvir (Penciclovir) C Rash Restlessness Tachycardia Weight Increased Date:11/02/04ISR Number: 4494098-2Report Type:Expedited (15-DaCompany Report #US_0410107257 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Diabetic Coma (Olanzapine) Renal Failure (Olanzapine) PS Date:11/02/04ISR Number: 4494100-8Report Type:Expedited (15-DaCompany Report #US_0410106997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/02/04ISR Number: 4494115-XReport Type:Expedited (15-DaCompany Report #USA041081494 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/02/04ISR Number: 4494128-8Report Type:Expedited (15-DaCompany Report #USA041081281 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Death Pneumonia Health Professional 24-Jun-2005 12:19 PM Page: 3175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/02/04ISR Number: 4494129-XReport Type:Expedited (15-DaCompany Report #USA041081232 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Failure Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/02/04ISR Number: 4494147-1Report Type:Expedited (15-DaCompany Report #2004071941 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Zoloft (Sertraline) PS 50 MG (1 IN 1 Hospitalization - Intentional Misuse Health D) Initial or Prolonged Lung Disorder Professional Olanzapine Other Pneumonitis Chemical Company (Olanzapine) SS 30 MG (1 IN 1 Suicide Attempt Representative D) Vomiting Bromazepam (Bromazepam) SS 2 MG (1 IN 1 D) Date:11/02/04ISR Number: 4494329-9Report Type:Expedited (15-DaCompany Report #FR_041005034 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Foreign Zyprexa-Dispersible Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Other Valium (Diazepam) C Fungizone (Amphotericin B) C Date:11/02/04ISR Number: 4494330-5Report Type:Expedited (15-DaCompany Report #EWC041041093 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Acholuric Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 3176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4494333-0Report Type:Expedited (15-DaCompany Report #AU_041008125 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS 10 MG Professional Valproate Semisodium C Other Date:11/02/04ISR Number: 4494337-8Report Type:Expedited (15-DaCompany Report #JP_041004841 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atopy Foreign Zyprexa Initial or Prolonged Condition Aggravated Health (Olanzapine) PS ORAL 10 MG DAY Professional Company Representative Other Date:11/02/04ISR Number: 4494338-XReport Type:Expedited (15-DaCompany Report #GBS040915541 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Endometrial Hypertrophy Foreign Olanzapine Postmenopausal Health (Olanzapine) PS ORAL 10 MG DAY Haemorrhage Professional Lithium C Uterine Polyp Other Date:11/02/04ISR Number: 4494339-1Report Type:Expedited (15-DaCompany Report #JP_041004909 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Study (Olanzapine) Other Hepatic Function Abnormal Health (Olanzapine) PS 5 MG DAY Soliloquy Professional Lodopin (Zotepine) C Other Cercine (Diazepam) C Halcion (Triazolam) C Depas (Etizolam) C Date:11/02/04ISR Number: 4494341-XReport Type:Expedited (15-DaCompany Report #FR_041005054 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersomnia Foreign Zyprexa-Oral Hypertension Consumer (Olanzapine) Weight Increased Other (Olanzapine) PS 10 MG/2 DAY Lysanxia (Prazepam) C Date:11/02/04ISR Number: 4494361-5Report Type:Expedited (15-DaCompany Report #EWC041040948 Age:65 YR Gender:Female I/FU:F Outcome PT Hospitalization - Bone Disorder Initial or Prolonged Bone Pain Other Femur Fracture 24-Jun-2005 12:19 PM Page: 3177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Leukocytosis Mucosal Dryness Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Disorder Foreign Zyprexa-Oral Neuroleptic Malignant Health (Olanzapine) Syndrome Professional (Olanzapine) PS 20 MG DAY Pyrexia Company Lorazepam C Rhabdomyolysis Representative Clotiapine C Tremor Other Date:11/02/04ISR Number: 4494386-XReport Type:Expedited (15-DaCompany Report #FR_040904858 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Foreign Zyprexa-Oral Initial or Prolonged Pyrexia Health (Olanzapine) Somnolence Professional (Olanzapine) PS 15 MG DAY Subileus Other Tercian (Cyamemazine) C Depakote (Valpraote Semisodium) C Fluanxol (Flupentixol Decanoate) C Date:11/02/04ISR Number: 4494388-3Report Type:Expedited (15-DaCompany Report #EWC020932249 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Foreign Zyprexa-Oral Overdose Other (Olanzapine) (Olanzapine) PS 20 MG/L IN THE EVENING Imovane (Zoplicone) C Propavan (Propiomazine Maleate) C Date:11/02/04ISR Number: 4494390-1Report Type:Expedited (15-DaCompany Report #CA_041007323 Age:97 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Foreign Zyprexa-Oral Initial or Prolonged Confusional State Consumer (Olanzapine) Coordination Abnormal Other (Olanzapine) PS 7.5 MG AT Depression BEDTIME Drug Interaction Haldol (Haloperidol Memory Impairment Decanoate) C Negative Thoughts Serax (Oxazepam) C Somnolence Speech Disorder Suicidal Ideation Weight Decreased 24-Jun-2005 12:19 PM Page: 3178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4494431-1Report Type:Expedited (15-DaCompany Report #JP_041004843 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Long Qt Syndrome Foreign Zyprexa-Oral Initial or Prolonged Ventricular Tachycardia Literature (Olanzapine) Health (Olanzapine) PS 1 DAY Professional Lidocaine C Other Date:11/02/04ISR Number: 4494432-3Report Type:Expedited (15-DaCompany Report #FR_041005059 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Zyprexa-Oral Hospitalization - Neuroleptic Malignant Health (Olanzapine) Initial or Prolonged Syndrome Professional (Olanzapine) PS 10 MG/1 DAY Company Deroxat (Paroxetine Representative Hydrochloride) C Other Anxiolytic C Date:11/02/04ISR Number: 4494433-5Report Type:Expedited (15-DaCompany Report #JP_040904475 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Decubitus Ulcer Health (Olanzapine) Other Depressed Level Of Professional (Olanzapine) PS Consciousness Company Depas (Etizolam) C Hyperhidrosis Representative Benzalin Hypoxia Other (Nitrazepam) C Intentional Misuse Hirnamin Muscle Rigidity (Levomepromazine) C Neuroleptic Malignant Syndrome Salivary Hypersecretion Sedation Stress Suicide Attempt Tachypnoea Date:11/02/04ISR Number: 4494447-5Report Type:Expedited (15-DaCompany Report #US_0409105286 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Zyprexa-Rapid-Acting Coma Health Im (Olanzapine) PS 20 MG/1 Somnolence Professional Haloperidol C Sudden Death Company Haloperidol C Representative Haloperidol C Other Levomepromazine C Diazepam C Carbamazepine (Carbamazepine) C 24-Jun-2005 12:19 PM Page: 3179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4494450-5Report Type:Expedited (15-DaCompany Report #EWC041040925 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Foreign Zyprexa-Rapid-Acting Restlessness Health Im (Olanzapine) PS 10 MG Professional Risperdal Other (Risperidone) C Norvasc (Amlodipine) C Bismoral C Dispirin (Acetylsalicylic Acid) C Date:11/02/04ISR Number: 4494453-0Report Type:Expedited (15-DaCompany Report #EWC040639724 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Foreign Zyprexa-Rapid-Acting Deterioration Health Im (Olanzapine) PS 10 MG/2 DAY 1 DAY Pulmonary Embolism Professional Midazolam C Sedation Other Haloperidol C Vital Functions Abnormal Biperiden C Clonazepam C Date:11/02/04ISR Number: 4494456-6Report Type:Expedited (15-DaCompany Report #JP_040904431 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Other Aspartate Professional (Olanzapine) PS 15 MG DAY Aminotransferase Company Gasmotin (Mosapride Increased Representative Citrate) C Blood Creatine Other Mucosta (Rebamipide) C Phosphokinase Increased Lac B (Lactobacillus Cachexia Bifidus, Eating Disorder Lyophilized) C Femur Fracture Berizym C Liver Disorder Pravastatin Sodium C Orthostatic Hypotension Nicotinamide C Pancytopenia Protein Total Decreased Date:11/03/04ISR Number: 4494635-8Report Type:Expedited (15-DaCompany Report #2004IC000854 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Dalmadorm "Icn" Initial or Prolonged Consciousness Health (Flurazepam Disturbance In Attention Professional Hydrochloride) 930 Eye Movement Disorder Mg) PS ORAL 20 MG; DAILY; Miosis ORAL Pupillary Reflex Impaired Seroquel (Quetiapine Respiratory Failure Fumarate) SS ORAL 200 MG;XL; Sleep Apnoea Syndrome ORAL Zyprexa (Olanzapine) (10 Mg) SS ORAL 10 MG; DAILY; ORAL 24-Jun-2005 12:19 PM Page: 3180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Temesta (Lorazepam) (2.5 Mg) SS ORAL 2.5 MG; 2 TIMES A DAY; ORAL Lithiofor C Depakine Chrono C Akineton C Date:11/03/04ISR Number: 4494698-XReport Type:Expedited (15-DaCompany Report #8007782 Age:62 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Acetaminophen Multiple Drug Overdose Health W/Hydrocodone Professional Bitartrate PS ORAL PO Opioid SS ORAL PO Olanzapine SS ORAL PO Date:11/03/04ISR Number: 4494870-9Report Type:Expedited (15-DaCompany Report #2004-BP-10171RO Age:26 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Methadone Hcl Drug Abuser Tablets Usp, 10 Mg Intentional Misuse (Methadone Hydrochloride) PS Alprazolam Intensol [Oral Solution (Concentrate)] 1 Mg/Ml (Alprazolam) SS Olanzapine (Olanzapine) SS Date:11/03/04ISR Number: 4495095-3Report Type:Expedited (15-DaCompany Report #2004-BP-10351RO Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Lithium Carbonate Completed Suicide Capsules Usp, 300 Multiple Drug Overdose Mg(Lithium Carbonate) PS Olanzapine (Olanzapine) SS Venlafaxine (Venlafaxine) SS Date:11/03/04ISR Number: 4495652-4Report Type:Expedited (15-DaCompany Report #2004-BP-10138RO Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Roxicet Tablets Multiple Drug Overdose (Oxycodone 5 Mg And Acetaminophen 325 Mg Tablets Usp) Oxycocet) PS Methadone Hcl Tablets Usp, 10 Mg 24-Jun-2005 12:19 PM Page: 3181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Methadone Hydrochloride) SS Olanzapine (Olanzapine) SS Date:11/04/04ISR Number: 4495874-2Report Type:Expedited (15-DaCompany Report #2004-BP-10319RO Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Cocaine Hcl Topical Completed Suicide Solution, 10% Multiple Drug Overdose (Cocaine) PS Propoxyphene (Dextropropoxyphene) SS Olanzapine (Olanzapine) SS Date:11/05/04ISR Number: 4493791-5Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0279158-00 Age:62 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Hydrocodone/Acetamin ophen PS ORAL Opioids SS ORAL Olanzapine SS ORAL Date:11/05/04ISR Number: 4494311-1Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0347536A Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Delirium Paxil PS Glaxosmithkline ORAL Diarrhoea Zyprexa SS ORAL 5 DAY Hyperhidrosis Amlodin C ORAL 5MG per day Irritability Maglax C ORAL 990MG per day Myoclonus Pantosin C ORAL 1200MG per Pyrexia day Restlessness Depas C ORAL 1MG per day Serotonin Syndrome Suicidal Ideation Tension Tremor Date:11/08/04ISR Number: 4497045-2Report Type:Periodic Company Report #US_0407104110 Age:57 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Abdominal Hernia Other Abnormal Behaviour Accidental Overdose Aggression Anger Animal Bite Ankle Operation Arthralgia Arthropathy Asthenia Back Pain 24-Jun-2005 12:19 PM Page: 3182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bronchitis Bronchitis Acute Burning Sensation Report Source Product Role Manufacturer Route Dose Duration Bursitis Consumer Prozac-Oral Cellulitis Health (Fluoxetine) Colonic Polyp Professional (Fluoxetine Completed Suicide Company Hydrochloride) PS 40 MG DAY Depression Representative Zyprexa-Oral Diarrhoea (Olanzapine) Diarrhoea Haemorrhagic (Olanzapine) SS 20 MG/1 AT Drug Ineffective BEDTIME Epicondylitis Clonazepam C Erectile Dysfunction Fluticasone Erythema Propionate C Fall Guaifenesin Feeling Abnormal (Guaifenesin C Feeling Drunk Hydrochlorothiazide C Gun Shot Wound Lansoprazole C Head Injury Lisinopril Headache (Lisinopril) C Hyperhidrosis Morphine Sulfate C Joint Swelling Naproxen (Naproxen Knee Arthroplasty Sodium) C Laceration Sildenafil Citrate C Lethargy Simvastatin Lip Pain "Orifarm" Loss Of Consciousness (Simvastatin Nausea Ratiopharm) C Oedema Effexor (Venlafaxine Osteoarthritis Hydrochloride) C Pain Venlafaxine C Pain Of Skin Rabeprazole C Pneumonia Lovastatin C Pruritus Percocet C Rectal Haemorrhage Tramadol C Rotator Cuff Repair Motrin (Ibuprofen) C Rotator Cuff Syndrome Omeprazole C Self-Injurious Ideation Albuterol C Septoplasty Sinusitis Somnolence Stress Suicidal Ideation Suicide Attempt Tachycardia Tendonitis Tooth Disorder Treatment Noncompliance Viral Upper Respiratory Tract Infection Vomiting Weight Increased Xanthogranuloma Date:11/08/04ISR Number: 4497051-8Report Type:Periodic Company Report #USA040876553 Age:65 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 3183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Other PT Report Source Product Role Manufacturer Route Dose Duration Back Injury Consumer Zyprexa-Oral Dysphonia Other (Olanzapine) Fall (Olanzapine) PS 20 MG/AT Memory Impairment NIGHT Myocardial Infarction Prozac-Oral Upper Limb Fracture (Fluoxetine) (Fluoxetine Hydrochloride) SS Lexapro (Escitalopram Oxalate) C Lisinopril (Lisinopril) C Depakote (Valproate Semisodium) C Date:11/08/04ISR Number: 4497053-1Report Type:Periodic Company Report #USA040875334 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antidepressant Drug Level Consumer Zyprexa-Oral Initial or Prolonged Increased (Olanzapine) Anxiety (Olanzapine) PS 10 MG DAY Blood Glucose Increased Prozac-Oral Depression (Fluoxetine) Hallucinations, Mixed (Fluoxetine Mental Impairment Hydrochloride) SS 80 MG IN THE Nocturia MORNING Weight Increased Lexapro (Escitalopram Oxalate) C Abilify (Aripiprazole) C Ambien (Zolpidem Tartrate) C Vioxx (Rofecoxib) C Duragesic (Fentanyl) C Ritalin (Methylphenidate Hydrochloride) C Date:11/08/04ISR Number: 4497333-XReport Type:Periodic Company Report #USA040670777 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Somnolence Professional (Olanzapine) Suicide Attempt Company (Olanzapine) PS 10 MG DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG DAY 24-Jun-2005 12:19 PM Page: 3184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/04ISR Number: 4497337-7Report Type:Periodic Company Report #USA040568461 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Symbyax-Olanzapine Initial or Prolonged Gastritis Professional 6mg / Fluoxetine Irritable Bowel Syndrome Company 25mg (Olanzapin PS Sinusitis Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/2 DAY Xanax (Alprazolam) C Depakote (Valproate Semisodium) C Date:11/09/04ISR Number: 4496422-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908652 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Topamax PS OROPHARINGEAL Completed Suicide Bupropion SS OROPHARINGEAL Intentional Misuse Venlafaxine SS Olanzapine SS OROPHARINGEAL Date:11/09/04ISR Number: 4496563-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041101068 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Tramadol Consciousness Hydrochloride PS OROPHARINGEAL Drug Interaction Morphine Sulphate SS INTRAVENOUS Pupillary Reflex Impaired Panadeine Forte SS UNKNOWN Respiratory Arrest Panadeine Forte SS UNKNOWN Haloperidol SS OROPHARINGEAL Nitrazepam SS OROPHARINGEAL Olanzapine SS OROPHARINGEAL Captopril C Thyroxine C Allopurinol C Trimethoprim C Date:11/09/04ISR Number: 4498300-2Report Type:Direct Company Report #CTU 231582 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Zyprexa PS Life-Threatening Diabetic Ketoacidosis Hospitalization - Hyperglycaemia Initial or Prolonged Hyperkalaemia Required Hypernatraemia Intervention to Hypotension Prevent Permanent Lactic Acidosis Impairment/Damage Metabolic Acidosis Pulse Absent Respiratory Acidosis Shock Urine Output Decreased 24-Jun-2005 12:19 PM Page: 3185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/04ISR Number: 4500351-6Report Type:Expedited (15-DaCompany Report #USA040670453 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Health Zyprexa-Oral Above Therapeutic Professional (Olanzapine) Coronary Artery Disease Company (Olanzapine) PS 40 MG DAY Drug Toxicity Representative Pulmonary Oedema Date:11/09/04ISR Number: 4500356-5Report Type:Expedited (15-DaCompany Report #USA041080573 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Zyprexa-Oral Blood Triglycerides (Olanzapine) Increased (Olanzapine) PS 50 MG 2 YR Condition Aggravated Lithium C Depression Depakote (Valproate Diabetes Mellitus Semisodium) C Dizziness Lasix (Furosemide) C Hypotension Atenolol C Impaired Healing Clonopin Liver Function Test (Clonazepam) C Abnormal Glucophage Mania (Metformin) C Nausea Baycol (Cerivastatin Oedema Sodium) C Pollakiuria Vioxx (Rofecoxib) C Renal Failure Mellaril Sexual Dysfunction (Thioridazine Sleep Apnoea Syndrome Hydrochloride) C Stress Tachycardia Thirst Treatment Noncompliance Tremor Visual Disturbance Vitreous Floaters Vomiting Weight Decreased Weight Increased Date:11/09/04ISR Number: 4500358-9Report Type:Expedited (15-DaCompany Report #US_0408104879 Age:41 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Pressure Systolic Initial or Prolonged Increased Contusion Diabetes Mellitus Fatigue Headache Impaired Healing Incontinence Laceration Upper Respiratory Tract Infection Vision Blurred Weight Decreased 24-Jun-2005 12:19 PM Page: 3186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG AT BEDTIME Zestril (Lisinopril) C Celexa (Citalopram Hydrobromide) C 'Thimox' C Celebrex (Celecoxib) C Singulair (Montelukast) C Nexium (Esomeprazole Magnesium) C 'Becusate' C Senokot (Senna Alexandrina) C Trazodone C Zyrtec (Cetirizine Hydrochloride) C Hydrochlorothiazide C Atrovent (Ipratropium Bromide) C Potassium C Vitamin C C Vitamin E (Herbal Oil Nos) C Date:11/09/04ISR Number: 4500362-0Report Type:Expedited (15-DaCompany Report #USA041080993 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-Oral Initial or Prolonged Dizziness (Olanzapine) Other Drooling (Olanzapine) PS 20 MG/1 AT Dry Mouth BEDTIME Head Injury Prozac-Oral Road Traffic Accident (Fluoxetine) Suicidal Ideation (Fluoxetine Weight Decreased Hydrochloride) SS 60 MG/1 DAY Weight Increased Date:11/09/04ISR Number: 4500367-XReport Type:Expedited (15-DaCompany Report #USA041080456 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative 24-Jun-2005 12:19 PM Page: 3187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/04ISR Number: 4500541-2Report Type:Expedited (15-DaCompany Report #US_0411107813 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coronary Artery Disease Consumer Zyprexa-Oral Diabetic Coma (Olanzapine) Erectile Dysfunction (Olanzapine) PS 10 MG Neurogenic Bladder Date:11/09/04ISR Number: 4500653-3Report Type:Expedited (15-DaCompany Report #US_0410107234 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Acute Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/09/04ISR Number: 4500657-0Report Type:Expedited (15-DaCompany Report #US_0410107223 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Extrapyramidal Disorder (Olanzapine) Myocardial Infarction (Olanzapine) PS Neuroleptic Malignant Syndrome Weight Increased Date:11/09/04ISR Number: 4501030-1Report Type:Expedited (15-DaCompany Report #US_0411107841 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/09/04ISR Number: 4501056-8Report Type:Expedited (15-DaCompany Report #USA041082025 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Zyprexa-Oral Weight Increased (Olanzapine) (Olanzapine) PS 40 MG DAY Ativan (Lorazepam) C Date:11/09/04ISR Number: 4501093-3Report Type:Expedited (15-DaCompany Report #USA041082401 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Olanzapine-Oral Professional (Olanzapine) PS Company Fluoxetine Representative (Fluoxetine) C 24-Jun-2005 12:19 PM Page: 3188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/04ISR Number: 4501095-7Report Type:Expedited (15-DaCompany Report #USA041082167 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS Representative Date:11/09/04ISR Number: 4501097-0Report Type:Expedited (15-DaCompany Report #USA041082046 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Consumer Zyprexa-Oral Initial or Prolonged Muscle Twitching (Olanzapine) Penis Disorder (Olanzapine) PS 10 MG/ 1 AT Visual Disturbance BEDTIME Date:11/09/04ISR Number: 4501129-XReport Type:Expedited (15-DaCompany Report #USA041082467 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa-Oral Off Label Use Professional (Olanzapine) Sudden Death Company (Olanzapine) PS Representative Date:11/09/04ISR Number: 4501130-6Report Type:Expedited (15-DaCompany Report #USA041082676 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Consumer Zyprexa-Oral Completed Suicide (Olanzapine) Gun Shot Wound (Olanzapine PS Sleep Disorder Date:11/09/04ISR Number: 4501153-7Report Type:Expedited (15-DaCompany Report #DE_041014538 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 10 MG/2 DAY Professional Tavor (Lorazepam) C Company Valproic Acid C Representative Lyogen Other (Fluphenazine) C Lyogen-Slow Release (Fluphenazine Deconate) C Truxal (Chlorprothixene Hydrochloride) C Dipiperon (Pipamperone Hydrochloride) C Akineton Retard (Biperiden Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Euthyrox (Levothyroxine Sodium) C Clexane (Enoxaparin Sodium) C Date:11/09/04ISR Number: 4501163-XReport Type:Expedited (15-DaCompany Report #EWC041040924 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 30 MG DAY Aspartate Professional Becozym C Aminotransferase Other Benerva (Thaimine Increased Hydrochloride) C Blood Cholesterol Folvite (Folic Acid) C Increased Risperdal Gamma-Glutamyltransferase (Risperidone) C Increased Liver Disorder Weight Increased Date:11/09/04ISR Number: 4501164-1Report Type:Expedited (15-DaCompany Report #FR_040504146 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zyprexa-Dispersible Initial or Prolonged Infection Health (Olanzapine) Pyrexia Professional (Olanzapine) PS 10 MG DAY Thrombotic Other Atarax (Hydroxyzine Microangiopathy Hydrochloride) C Date:11/09/04ISR Number: 4501167-7Report Type:Expedited (15-DaCompany Report #JP_041004651 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 5 MG DAY Aminotransferase Company Rohypnol Increased Representative (Flunitrazepam Eg) C Hepatic Function Abnormal Other Date:11/09/04ISR Number: 4501168-9Report Type:Expedited (15-DaCompany Report #GBS041015690 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Zyprexa-Oral Hospitalization - Condition Aggravated Health (Olanzapine) Initial or Prolonged Deep Vein Thrombosis Professional (Olanzapine) PS 5 MG DAY Irritable Bowel Syndrome Other Mirtazapine C Mental Disorder Carbamazepine C Pulmonary Embolism Tolterodine C Treatment Noncompliance Thyroxine Weight Increased (Levothyroxine Sodium) C Naproxen (Naproxen 24-Jun-2005 12:19 PM Page: 3190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Calcium C Date:11/09/04ISR Number: 4502110-7Report Type:Expedited (15-DaCompany Report #EWC040639724 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zyprexa-Rapid-Acting Sedation Health Im (Olanzapine) PS 10 MG/2 DAY 1 DAY Professional Midazolam C Other Haloperidol C Biperiden C Clonazepam C Date:11/09/04ISR Number: 4502115-6Report Type:Expedited (15-DaCompany Report #JP_041004648 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG DAY Aminotransferase Company Increased Representative Gamma-Glutamyltransferase Other Increased Date:11/09/04ISR Number: 4502248-4Report Type:Expedited (15-DaCompany Report #AU_041008138 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prescribed Overdose Foreign Olanzapine Hospitalization - Respiratory Failure Health (Olanzapine) PS ORAL 30 MG DAY Initial or Prolonged Professional Aspirin Company (Acetylsalicylic Representative Acid) C Other Valproate Sodium C Simvastatin C Frusemide C Lithium C Thyroxine (Levothyroxine Sodium) C Spironolactone (Spironolactone) C Date:11/09/04ISR Number: 4502249-6Report Type:Expedited (15-DaCompany Report #GBS041015834 Age:64 YR Gender:Female I/FU:I Outcome PT Life-Threatening Arthralgia Body Fat Disorder Cardiac Disorder Cardiovascular Disorder Clubbing Constipation Cushingoid Dry Mouth Gait Disturbance 24-Jun-2005 12:19 PM Page: 3191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Head Injury Headache Insomnia Report Source Product Role Manufacturer Route Dose Duration Mental Impairment Foreign Olanzapine Micturition Urgency Health Pain In Extremity Professional (Olanzapine) PS ORAL 20 MG Palpitations Other Pollakiuria Psychiatric Symptom Respiration Abnormal Schizophrenia Somnolence Tooth Disorder Urinary Incontinence Vein Disorder Visual Disturbance Weight Increased Date:11/09/04ISR Number: 4502250-2Report Type:Expedited (15-DaCompany Report #US_0410107286 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine Initial or Prolonged Increased Literature (Olanzapine) PS ORAL 15 MG DAY 1 WK Aspartate Health Clozapine C Aminotransferase Professional Increased Other Bilirubin Conjugated Increased Blood Bilirubin Increased Hypoproteinaemia Liver Function Test Abnormal Mean Cell Volume Abnormal Pancytopenia Vitamin B12 Deficiency Weight Increased Date:11/09/04ISR Number: 4502251-4Report Type:Expedited (15-DaCompany Report #DE_041014555 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrophy Foreign Zyprexa Initial or Prolonged Parkinson'S Disease Health (Olanzapine) PS 2.5 MG/1 DAY Professional Quilonum - Slow Other Release (Lithium Carbonate) C Cipramil (Citalopram Hydrobromide) C Dociton (Propranolol Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/04ISR Number: 4502252-6Report Type:Expedited (15-DaCompany Report #DE_041014564 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Nodosum Foreign Zyprexa-Oral Induration Health (Olanzapine) Leukocytosis Professional (Olanzapine) PS 20 MG DAY Muscle Disorder Other Cefuhexal Oedema (Cefuroxime) C Red Blood Cell Sedimentation Rate Increased Sinobronchitis Vein Disorder Weight Increased Date:11/09/04ISR Number: 4502253-8Report Type:Expedited (15-DaCompany Report #DE_041014557 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Zyprexa-Oral Initial or Prolonged Dyspnoea Health (Olanzapine) General Physical Health Professional (Olanzapine) PS 20 MG DAY Deterioration Other Quilonum (Lithium Neuroleptic Malignant Acetate) C Syndrome Akineton (Biperiden Rhabdomyolysis Lactate) C Euthyrox (Levothyroxine Sodium) C Captohexal (Captopril Biochemie) C Ferro Sanol C Date:11/09/04ISR Number: 4502263-0Report Type:Expedited (15-DaCompany Report #DE_041014551 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleurothotonus Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Tavor (Lorazepam) C Allopurinol C Ass (Acetylsalicylic Acid) C Neo-Thyreostat (Carbimazole) C Cipramil (Citalopram Hydrobromide) C Date:11/09/04ISR Number: 4502265-4Report Type:Expedited (15-DaCompany Report #JP_041105013 Age:23 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Ineffective Initial or Prolonged Incoherent Psychiatric Evaluation Abnormal 24-Jun-2005 12:19 PM Page: 3193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Literature (Olanzapine) Health (Olanzapine) PS 3 WK Professional Other Date:11/09/04ISR Number: 4502266-6Report Type:Expedited (15-DaCompany Report #JP_041105012 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Incoherent Foreign Zyprexa-Oral Initial or Prolonged Psychiatric Evaluation Literature (Olanzapine) Abnormal Health (Olanzapine) PS 4 WK Professional Other Date:11/09/04ISR Number: 4502267-8Report Type:Expedited (15-DaCompany Report #JP_041004967 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 10 MG DAY Professional Amoban (Zopiclone) C Other Date:11/10/04ISR Number: 4497542-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908827 Age:59 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Ultracet PS OROPHARINGEAL Coma Lorazepam SS OROPHARINGEAL Completed Suicide Naproxen SS OROPHARINGEAL Haemodialysis Belladonna/Ergotamin Hypotension e/Phenobarbital SS Intentional Misuse Losartan SS Mental Status Changes Quinine SS Multi-Organ Failure Levothyroxine SS Renal Failure Haloperidol SS Vomiting Olanzapine SS Hydroxyzine SS Setraline SS Date:11/10/04ISR Number: 4502391-XReport Type:Expedited (15-DaCompany Report #T04-GER-07295-01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Ejaculation Disorder Study Hydrobromide) PS ORAL 60 MG QD PO Health Edronax (Reboxetine) SS ORAL 4 MG QD PO Professional Zyprexa (Olanzapine) SS ORAL 20 MG QD PO Other Zyprexa (Olanzapine) SS ORAL 10 MG, QD, PO Zyprexa (Olanzapine) SS ORAL 5 MG QD PO Zyprexa (Olanzapine) SS 2.5 MG QD 24-Jun-2005 12:19 PM Page: 3194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor (Metoprolol Tartrate) C Triarese C Celebrex (Celecoxib) C Ximovan (Zopiclone) C Trevilor (Venlafaxine Hydrochloride) C Ergenyl Chrono C Date:11/10/04ISR Number: 4502392-1Report Type:Expedited (15-DaCompany Report #T04-GER-07294-01 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Cipramil (Citalopram Initial or Prolonged Drug Interaction Study Hydrobromide) PS ORAL 20 MG QD PO Masked Facies Other Zyprexa (Olanzapine) SS ORAL 15 MG QD PO Posture Abnormal Tremor Date:11/10/04ISR Number: 4502393-3Report Type:Expedited (15-DaCompany Report #T04-GER-07297-01 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Dystonia Health Hydrobromide) PS ORAL 40 MG QD PO Pleurothotonus Professional Cipramil (Citalopram Other Hydrobromide) SS ORAL 20 MG QD PO Cipramil (Citalopram Hydrobromide) SS ORAL 40 MG QD PO Zyprexa (Olanzapine) SS Zyprexa (Olanzapine) SS Tavor (Lorazepam) C Allopurinol C Asa (Acetylsalicylic Acid) C Carbimazole C Seroquel (Quetiapine Fumarate) C Date:11/10/04ISR Number: 4502395-7Report Type:Expedited (15-DaCompany Report #T04-GER-07360-01 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Myoclonus Study Hydrobromide) PS ORAL 40 MG QD PO Health Cipramil (Citalopram Professional Hydrobromide) SS ORAL 40 MG QD PO Other Cipramil (Citalopram Hydrobromide) SS ORAL 20 MG QD PO Cipramil (Citalopram Hydrobromide) SS ORAL 40 MG QD PO Zyprexa (Olanzapine) SS ORAL 5 MG QD PO Zyprexa (Olanzapine) SS ORAL 10 MG QD PO Stangyl (Trimipramine Maleate) C 24-Jun-2005 12:19 PM Page: 3195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone C Date:11/10/04ISR Number: 4502396-9Report Type:Expedited (15-DaCompany Report #T04-GER-07359-01 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrophy Foreign Cipramil (Citalopram Initial or Prolonged Drug Interaction Study Hydrobromide) PS ORAL 80 MG QD PO Parkinsonism Health Quilonum - Slow Prescribed Overdose Professional Release (Lithium Other Carbonate) SS ORAL 675 MG QD PO Zyprexa (Olanzapine) SS ORAL 2.5 MG QD PO Dociton (Propranolol Hydrochloride) C Euthyrox (Levothyroxine Sodium) C Date:11/10/04ISR Number: 4502525-7Report Type:Expedited (15-DaCompany Report #FRWYE081401OCT04 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Effexor (Venlafaxine Initial or Prolonged Confusional State Professional Hydrochloride, 0) PS ORAL Hypercapnia Other Mopral (Omeprazole, Nervous System Disorder 0) SS Somnolence Xanax (Alprazolam, Superinfection Lung 0) SS Zyprexa (Olanzapine, 0) SS Date:11/10/04ISR Number: 4502580-4Report Type:Expedited (15-DaCompany Report #DEWYE160729OCT04 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Trevilor Initial or Prolonged Intentional Misuse Professional (Venlafaxine Miosis Hydrochloride, Tachycardia Tablet, 0) PS ORAL 2 TABLETS (OVERDOSE AMOUNT 125 MG) ORAL 1 DAY Risperdal (Risperidone, 0) SS ORAL 6 TABLETS IN 12 HOURS, ORAL 1 DAY Stangyl (Trimipramine Maleate, , 0) SS ORAL 1 TABLET, ORAL 1 DAY Zoloft (Sertraline Hydrochloride, , 0) SS ORAL 20 TABLETS (OVERDOSE AMOUTN 1000 MG), ORAL 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 3 TABLETS, ORAL 1 DAY 24-Jun-2005 12:19 PM Page: 3196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/11/04ISR Number: 4499256-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908824 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Ultram PS OROPHARINGEAL Completed Suicide Ultracet SS OROPHARINGEAL General Physical Health Risperidone SS Deterioration Lithium SS OROPHARINGEAL Haemodialysis Alprazolam SS Heart Rate Increased Diazepam SS Hypotension Nefazodone SS Intentional Misuse Olanzapine SS Loss Of Consciousness Nalbuphine SS Pneumothorax Therapy Non-Responder Date:11/11/04ISR Number: 4499259-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908819 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Ultram PS OROPHARINGEAL Diabetes Mellitus Fentanyl SS Insulin-Dependent Clonazepam SS OROPHARINGEAL Drug Toxicity Carisoprodol SS OROPHARINGEAL Multiple Drug Overdose Ethanol SS Cocaine SS Olanzapine SS Date:11/12/04ISR Number: 4500159-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908884 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Tylox PS OROPHARINGEAL Multiple Drug Overdose Professional Methadone SS OROPHARINGEAL Narcotic Intoxication Olanzapine SS OROPHARINGEAL Date:11/15/04ISR Number: 4500816-7Report Type:Expedited (15-DaCompany Report #JP-MERCK-0411USA01770 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Cozaar PS Merck & Co., Inc ORAL 24 DAY Neuroleptic Malignant Symmetrel SS ORAL Syndrome Zyprexa SS ORAL Risperdal SS ORAL Date:11/15/04ISR Number: 4504127-5Report Type:Expedited (15-DaCompany Report #2003UW16014 Age:21 YR Gender:Female I/FU:F Outcome PT Death Abdominal Pain Abdominal Pain Upper Asthenia Back Pain Cardio-Respiratory Arrest Coma Coronary Artery Disease Dizziness Drug Level Increased 24-Jun-2005 12:19 PM Page: 3197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Hepatic Steatosis Impaired Work Ability Report Source Product Role Manufacturer Route Dose Duration Metabolic Disorder Health Seroquel PS Pancreatic Necrosis Professional Seroquel SS 175 MG DAILY Pancreatitis Haemorrhagic Zyprexa SS ORAL 7.5 MG DAILY Paracentesis Eye Abnormal PO Vomiting Zyprexa SS ORAL 15 MG DAILY PO Zyprexa SS 10 MG HS Zyprexa SS 3 DF QD Ativan C Vistaril C Depo-Provera C Not Match C Advil C Ambien C Septra Ds C Metronidazole C Doxycycline C Temazepam C Roxicet C Date:11/16/04ISR Number: 4504667-9Report Type:Expedited (15-DaCompany Report #DSA_25213_2004 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Tavor PS ORAL 10 MG ONCE PO Initial or Prolonged Electrocardiogram Qt Health Cognac SS ORAL 1.4 L ONCE PO Required Prolonged Professional Remergil SS ORAL 2400 MG ONCE Intervention to Intentional Misuse Other PO Prevent Permanent Loss Of Consciousness Zyprexa SS ORAL 140 MG ONCE Impairment/Damage Respiratory Depression PO Date:11/16/04ISR Number: 4505036-8Report Type:Expedited (15-DaCompany Report #JP_040904519 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Foreign Zyprexa-Oral Anxiety Study (Olanzapine) Condition Aggravated Health (Olanzapine) PS 10 MG/1 DAY Dyslalia Professional Risperdal Irritability Other (Risperidone) C Rohypnol (Flunitrazepam) C Akineton (Biperiden Lactate) C Date:11/17/04ISR Number: 4506627-0Report Type:Expedited (15-DaCompany Report #2004079238 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Professional Olanzapine Company (Olanzapine) SS 5 MG Representative Drug, Unspecified (Drug, Unspecified) SS Haloperidol 24-Jun-2005 12:19 PM Page: 3198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decanoate (Haloperidol Decanoate) C Date:11/17/04ISR Number: 4524635-0Report Type:Periodic Company Report #C2003-1514.01 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan Other Zyprexa Tablets Eli Lilly SS ORAL 50MG Q HS, ORAL Date:11/18/04ISR Number: 4507133-XReport Type:Expedited (15-DaCompany Report #B0349829A Age:49 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paroxetine Health Hydrochloride Professional (Formulation Unknown) (Generic) (Paroxetine PS ORAL ORAL Olanzapine (Formulation Unknown) (Olanzapine) SS ORAL ORAL Date:11/18/04ISR Number: 4507703-9Report Type:Expedited (15-DaCompany Report #B0349849A Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Lithium Salt Completed Suicide Health (Formulation Professional Unknown) (Lithium Salt) PS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) SS ORAL ORAL Date:11/19/04ISR Number: 4506004-2Report Type:Periodic Company Report #FR-JNJFOC-20041100357 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Muscle Spasticity Risperdal PS OROPHARINGEAL Zyprexa SS Date:11/19/04ISR Number: 4509029-6Report Type:Direct Company Report #CTU 232523 Age: Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 3199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Zyprexa Lilly Oedema Peripheral Company PS Lilly 5 MG / DAY Retinal Artery Stenosis Vision Blurred Visual Acuity Reduced Vitreous Floaters Date:11/19/04ISR Number: 4509506-8Report Type:Expedited (15-DaCompany Report #USA040979222 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Health Zyprexa-Oral Initial or Prolonged Bile Duct Obstruction Professional (Olanzapine) Other Blood Test Abnormal Company (Olanzapine) PS 5 MG/1 DAY 1 WK Cholangitis Representative Sepsis Date:11/19/04ISR Number: 4509563-9Report Type:Expedited (15-DaCompany Report #US_0411107895 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Life-Threatening Diabetic Ketoacidosis (Olanzapine) Other Injury (Olanzapine) PS Date:11/19/04ISR Number: 4509836-XReport Type:Expedited (15-DaCompany Report #US_0411107794 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa-Oral Initial or Prolonged Discomfort Professional (Olanzapine) Hallucination, Auditory (Olanzapine) PS Nervous System Disorder Suicidal Ideation Date:11/19/04ISR Number: 4509862-0Report Type:Expedited (15-DaCompany Report #USA041183126 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Gun Shot Wound Professional 6mg / Fluoxetine Therapy Non-Responder Company 25mg (Olanzapine PS 2 DAY Representative Date:11/19/04ISR Number: 4509866-8Report Type:Expedited (15-DaCompany Report #EWC041040924 Age:49 YR Gender:Female I/FU:F Outcome PT Other Alanine Aminotransferase Increased Aspartate Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 3200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Cholesterol Increased Gamma-Glutamyltransferase Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Olanzapine-Oral Liver Disorder Health (Olanzapine) PS 30 MG DAY Weight Increased Professional Becozym C Other Benerva (Thiamine Hydrochloride) C Folvite (Folic Acid) C Risperdal (Risperidone) C Date:11/19/04ISR Number: 4509868-1Report Type:Expedited (15-DaCompany Report #DE_041014538 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Foreign Zyprexa-Rapid-Acting Sedation Health Im (Olanzapine) PS 10 MG/1 DAY Professional Tavor (Lorazepam) C Company Valproic Acid C Representative Lyogen Other (Fluphenazine) C Lyogen - Slow Release (Fluphenazine Decanoate) C Truxal (Chlorprothixene Hydrochloride) C Dipiperon (Pipamperone Hydrochloride) C Akineton Retard (Biperiden Hydrochloride) C Euthyrox (Levothyroxine Sodium) C Clexane (Enoxaparin Sodium) C Date:11/19/04ISR Number: 4509873-5Report Type:Expedited (15-DaCompany Report #JP_041004651 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Study (Olanzapine) Aspartate Health (Olanzapine) PS 5 MG DAY Aminotransferase Professional Rohypnol Increased Other (Flunitrazepam Eg) C Hepatic Function Abnormal Date:11/19/04ISR Number: 4509883-8Report Type:Expedited (15-DaCompany Report #USA041082509 Age: Gender:Male I/FU:I Outcome PT Report Source Death Completed Suicide Health Professional 24-Jun-2005 12:19 PM Page: 3201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Paxil (Paroxetine Hydrochloride) C Date:11/19/04ISR Number: 4509899-1Report Type:Expedited (15-DaCompany Report #US_0404102245 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Zyprexa-Oral Initial or Prolonged Abdominal Pain Upper Health (Olanzapine) Other Angina Unstable Professional (Olanzapine) PS 50 MG/1 DAY Asthenia Prozac-Oral Back Pain (Fluoxetine) Bundle Branch Block Left (Fluoxetine Confusional State Hydrochloride) C 30 MG/1 DAY Constipation Effexor-Xr Crying (Venlafaxine Decreased Appetite Hydrochloride) C Dehydration Xanax (Alprazolam Depression Dum) C Diabetes Mellitus Bentyl Non-Insulin-Dependent (Dicycloverine Disturbance In Attention Hydrochloride) C Dysuria Lipitor Electrocardiogram T Wave (Atorvastatin Inversion Calcium) C Eye Disorder Imdur (Isosorbide Flatulence Mononitrate) C Heart Rate Increased Pepcid Ac Hepatic Steatosis (Famotidine) C Hunger Geodon (Ziprasidone Hyperlipidaemia Hydrochloride) C Hypokalaemia Topamax (Topiramate) C Insomnia Ischaemia Joint Sprain Mucosal Dryness Nausea Pain In Extremity Pollakiuria Renal Cyst Sepsis Somnolence Thirst Urinary Tract Infection Vision Blurred Weight Decreased Date:11/19/04ISR Number: 4509900-5Report Type:Expedited (15-DaCompany Report #USA041183051 Age:45 YR Gender:Male I/FU:I Outcome PT Death Myocardial Infarction Other Obesity 24-Jun-2005 12:19 PM Page: 3202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/19/04ISR Number: 4509901-7Report Type:Expedited (15-DaCompany Report #USA041183084 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laboratory Test Abnormal Consumer Zyprexa-Oral Initial or Prolonged Neoplasm Progression (Olanzapine) (Olanzapine) PS 5 MG/1 DAY Date:11/19/04ISR Number: 4509916-9Report Type:Expedited (15-DaCompany Report #USA041082581 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Date:11/19/04ISR Number: 4509917-0Report Type:Expedited (15-DaCompany Report #USA041182807 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Consumer Zyprexa-Oral Blood Cholesterol (Olanzapine) Increased (Olanzapine) PS 10 MG/1 DAY Blood Pressure Increased Prozac-Oral Burning Sensation (Fluoxetine) Diabetes Mellitus (Fluoxetine Heart Rate Increased Hydrochloride) SS 40 MG/1 DAY 1 WK Hypersensitivity Prilosec (Omeprazole Insomnia Ratiopharm) C Respiratory Disorder Weight Decreased Weight Increased Date:11/19/04ISR Number: 4509942-XReport Type:Expedited (15-DaCompany Report #JP_040904382 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Thyroid Stimulating Foreign Zyprexa-Oral Hormone Decreased Health (Olanzapine) Hyperthyroidism Professional (Olanzapine) PS 5 MG DAY Company Depas (Etizolam) C Representative Rohypnol Other (Flunitrazepam) C 24-Jun-2005 12:19 PM Page: 3203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/04ISR Number: 4509953-4Report Type:Expedited (15-DaCompany Report #JP_040904591 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG DAY Aminotransferase Company Paxil (Paroxetine Increased Representative Hydrochloride) C Blood Alkaline Other Dogmatyl (Sulpiride) C Phosphatase Increased Lexotan (Bromazepam) C Gamma-Glutamyltransferase Levotomin Increased (Levomepromazine Hepatic Function Abnormal Maleate) C Rhythmy (Rilmazafone) C Date:11/19/04ISR Number: 4509965-0Report Type:Expedited (15-DaCompany Report #US_0409105286 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Somnolence Foreign Zyprexa-Rapid-Acting Sudden Death Health Im (Olanzapine) PS 20 MG/1 Professional Haloperidol C Company Levomepromazine C Representative Diazepam C Other Carbamazepine (Carbamazepine) C Date:11/19/04ISR Number: 4510172-6Report Type:Expedited (15-DaCompany Report #FR_041105149 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Representative Other Date:11/19/04ISR Number: 4510177-5Report Type:Expedited (15-DaCompany Report #GBS041115871 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Olanzapine-Oral Initial or Prolonged Hepatic Failure Health (Olanzapine) PS 10 MG Multi-Organ Failure Professional Diazepam C Rhabdomyolysis Other Promazine C Dothiepin C Zopiclone (Zopiclone) C Date:11/19/04ISR Number: 4510367-1Report Type:Expedited (15-DaCompany Report #AU_041108163 Age: Gender:Female I/FU:I Outcome PT Report Source Death Death Foreign Health 24-Jun-2005 12:19 PM Page: 3204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa (Olanzapine) PS INTRAMUSCULAR Date:11/19/04ISR Number: 4510375-0Report Type:Expedited (15-DaCompany Report #DE_041014560 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Foreign Zyprexa Health Professional (Olanzapine) PS ORAL 5 MG DAY Company Aquaphor Tablet Representative (Xipamide) C Other Remergil (Mirtazapine Orifarm) C Date:11/19/04ISR Number: 4510442-1Report Type:Expedited (15-DaCompany Report #JP_041105061 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa Choking Health (Olanzapine) PS ORAL 20 MG DAY Professional Diazepam C Company Biperiden C Representative Nitrazepam C Other Date:11/19/04ISR Number: 4510444-5Report Type:Expedited (15-DaCompany Report #US_0411107587 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa Confusional State Health (Olanzapine) PS ORAL 5 MG/1 DAY Hyponatraemia Professional Sertraline C Sedation Company Somnolence Representative Other Date:11/19/04ISR Number: 4512809-4Report Type:Direct Company Report #CTU 232485 E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Olanzapine PS ORAL 25 MG PO HS Initial or Prolonged Thrombocytopenic Purpura Gabapentin SS ORAL 400 MG PO AM 800 MG HS Date:11/19/04ISR Number: 4512847-1Report Type:Direct Company Report #CTU 232475E Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Olanzapine PS ORAL 20 MG HS Initial or Prolonged Diabetes Mellitus ORAL Weight Increased Risperidone SS ORAL 2 MG BID 24-Jun-2005 12:19 PM Page: 3205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:11/22/04ISR Number: 4506586-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041102757 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Tramal PS UNKNOWN Serotonin Syndrome Tramal SS UNKNOWN Mirtazapine C UNKNOWN Diazepam C UNKNOWN Lansoprazole C UNKNOWN Prochlorperazine C UNKNOWN Olanzapine I UNKNOWN Date:11/22/04ISR Number: 4506622-1Report Type:Expedited (15-DaCompany Report #JP-MERCK-0411USA01770 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Chronic Cozaar PS Merck & Co., Inc ORAL 23 DAY Hospitalization - Decreased Appetite Cozaar SS Merck & Co., Inc ORAL Initial or Prolonged Depressed Level Of Cozaar SS Merck & Co., Inc ORAL 23 DAY Consciousness Cozaar SS Merck & Co., Inc ORAL Femoral Neck Fracture Symmetrel SS ORAL Hypertension Zyprexa SS ORAL Multi-Organ Failure Risperdal SS ORAL Neuroleptic Malignant Syndrome Date:11/22/04ISR Number: 4506848-7Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280809-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Hesitation Epilim PS ORAL Urinary Retention Olanzapine SS ORAL Temazepam SS ORAL Date:11/22/04ISR Number: 4507058-XReport Type:Expedited (15-DaCompany Report #US-MERCK-0411USA03084 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Zocor PS Merck & Co., Inc ORAL Diarrhoea Combivir SS ORAL Drug Interaction Lithium Carbonate SS ORAL Nausea Zyprexa SS UNKNOWN Therapeutic Agent Bactrim SS UNKNOWN Toxicity Sustiva SS UNKNOWN Vomiting Concerta SS UNKNOWN Date:11/22/04ISR Number: 4510436-6Report Type:Expedited (15-DaCompany Report #KII-2004-0013986 Age:45 YR Gender:Male I/FU:I Outcome PT Other Acidosis Blood Alkaline Phosphatase Increased Blood Bicarbonate Decreased 24-Jun-2005 12:19 PM Page: 3206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Chloride Increased Blood Magnesium Increased Blood Pressure Systolic Report Source Product Role Manufacturer Route Dose Duration Increased Study Oxycodone Chest Pain Health Hydrochloride Cough Professional (Similar To Nda Diabetes Insipidus Other 20-553)(Oxycodone Hypokalaemia Hydrochloride) PS ORAL ORAL Multiple Drug Overdose Olanzapine(Olanzapin Pco2 Decreased e) SS ORAL ORAL Po2 Decreased Gabapentin(Gabapenti Somnolence n) SS ORAL ORAL White Blood Cell Count Sertraline Increased (Sertraline) SS ORAL ORAL Benzodiazepine Derivatives() SS ORAL ORAL Lithium (Lithium) SS ORAL ORAL Date:11/22/04ISR Number: 4511255-7Report Type:Direct Company Report #CTU 232726 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dehydration Zyprexa 10 Mg Intervention to Hypotension Lilly PS Lilly INTRAMUSCULAR 10 MG ONCE Prevent Permanent Orthostatic Hypotension INTRAMUSCULAR Impairment/Damage Tachycardia Date:11/23/04ISR Number: 4512374-1Report Type:Expedited (15-DaCompany Report #DSA_25334_2004 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Foreign Temesta PS ORAL 2.5 MG Q DAY Initial or Prolonged White Blood Cell Count Consumer PO Decreased Other Zyprexa SS ORAL 20 MG Q DAY PO Atenolol SS ORAL 50 MG Q DAY PO Zestoretic SS DF Lopirin C Adalat C Nitrolingual C Catapressan C Date:11/24/04ISR Number: 4510415-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0502021A Age:9 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Anger Anorexia Arrhythmia Cognitive Disorder Depression Dystonia Eye Rolling Fear Myalgia 24-Jun-2005 12:19 PM Page: 3207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nightmare Pain In Extremity Self Mutilation Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Health Paxil PS Glaxosmithkline ORAL 30MG per day Suicide Attempt Professional Zoloft SS ORAL 25MG Three Swollen Tongue times per day Zyprexa SS Date:11/24/04ISR Number: 4510454-8Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0347536A Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Consumer Paxil PS Glaxosmithkline ORAL Delirium Zyprexa SS ORAL 5 DAY Diarrhoea Amlodin C ORAL 5MG per day Hyperhidrosis Maglax C ORAL 990MG per day Irritability Pantosin C ORAL 1200MG per Myoclonus day Pyrexia Depas C ORAL 1MG per day Restlessness Serotonin Syndrome Suicidal Ideation Tension Tremor Date:11/24/04ISR Number: 4510587-6Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280885-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Epilim PS UNKNOWN Increased Clozapine SS ORAL Leukocytosis Olanzapine SS UNKNOWN Sinus Tachycardia Olanzapine SS UNKNOWN Fluoxetine Hydrochloride SS UNKNOWN Date:11/24/04ISR Number: 4512444-8Report Type:Expedited (15-DaCompany Report #USA041183703 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Zyprexa-Oral Initial or Prolonged Anaemia Professional (Olanzapine) Other Drug Withdrawal (Olanzapine) PS 10 MG/1 DAY Convulsions Zoloft (Sertraline Epistaxis Hydrochloride) C Face Injury Ativan (Lorazepam) C Fall Grand Mal Convulsion Headache Hypertensive Encephalopathy Intentional Misuse Musculoskeletal Stiffness Suicide Attempt Tongue Biting 24-Jun-2005 12:19 PM Page: 3208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/04ISR Number: 4512486-2Report Type:Expedited (15-DaCompany Report #US_0404101993 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Anorexia (Olanzapine) PS 45 MG/1 AT Back Pain BEDTIME Biliary Tract Disorder Prolixin Blood Cholesterol (Fluphenazine Abnormal Hydrochloride) C Body Temperature Artane Increased (Trimexyphenidyl Diabetes Mellitus Hydrochloride) C Diabetic Ketoacidosis Triamterene/Hydrochl Diarrhoea orothiazide C Dysuria Accupril (Quinapril Gastritis Hydrochloride) C General Physical Health Asa (Acetylsalicylic Deterioration Acid) C Haematocrit Increased Metroclopramide Haemoglobin Increased (Metoclopramide Hypertension Hydrochloride) C Hyponatraemia Diphenoxylate Lipase Increased W/Atropine Sulfate C Nausea Atropine Vomiting W/Hyoscine/Hysocyami ne/Phenobarbital C Ultracet C Prozac (Fluoxeitine Hydrochloride) C Prilosec (Omeprazole Ratiopharm) C Date:11/24/04ISR Number: 4512487-4Report Type:Expedited (15-DaCompany Report #USA041183274 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Zyprexa-Oral Therapeutic Agent Professional (Olanzapine) PS Toxicity Company Representative Date:11/24/04ISR Number: 4512499-0Report Type:Expedited (15-DaCompany Report #USA041183746 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Health Zyprexa-Oral Oedema Peripheral Professional (Olanzapine) Proteinuria (Olanzapine) PS 20 MG/1 DAY Treatment Noncompliance Depakote (Valproate Urinary Tract Infection Semisodium) C Paxil (Paroxetine Hydrochloride) C Ambien (Zolpidem Tartrate) C 24-Jun-2005 12:19 PM Page: 3209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/04ISR Number: 4512500-4Report Type:Expedited (15-DaCompany Report #USA041183735 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Exposure During Health Zyprexa-Oral Pregnancy Professional (Olanzapine) PS Intra-Uterine Death Company Umbilical Cord Around Representative Neck Date:11/24/04ISR Number: 4512516-8Report Type:Expedited (15-DaCompany Report #US_0404102245 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Zyprexa-Oral Initial or Prolonged Abdominal Pain Upper Health (Olanzapine) Other Angina Unstable Professional (Olanzapine) PS 50 MG/1 DAY Asthenia Prozac-Oral Back Pain (Fluoxetine) Blood Cholesterol (Fluoxetine Increased Hydrochloride) SS 80 MG/1 DAY Blood Triglycerides Humulin N (Insulin Increased Human Injection, Bundle Branch Block Left Isophane) C Chest Pain Humulin R (Insulin Confusional State Human) C Constipation Effexor-Xr Crying (Venlafaxine Decreased Appetite Hydrochloride) C Dehydration Xanax (Alprazolam Depression Dum) C Diabetes Mellitus Bentyl Inadequate Control (Dicycloverine Disturbance In Attention Hydrochloride) C Dysuria Lipitor Ejection Fraction (Atorvastatin Decreased Calcium) C Electrocardiogram T Wave Imdur (Isosorbide Inversion Mononitrate) C Glycosuria Pepcid Ac Headache (Famotidine) C Heart Rate Increased Geodon (Ziprasidne Hepatic Steatosis Hydrochloride) C Hunger Topamax (Topiramate) C Hyperlipidaemia Ultram (Tramadol Hypokalaemia Hydrochloride) C Initial Insomnia Propoxyphene Joint Sprain Napsylate C Lethargy Ibuprofen C Mucosal Dryness Skelaxin Myocardial Ischaemia (Metaxalone) C Nausea Celebrex (Celecoxib) C Pollakiuria Cyclobenzaprine C Renal Cyst Roxicet C Sepsis Seroquel (Quetiapine Somnolence Fumarate) C Thirst Risperidone C Vision Blurred Lithum Carbonate C Weight Decreased Lopressor Weight Increased (Metoprolol Tartrate) C 24-Jun-2005 12:19 PM Page: 3210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/04ISR Number: 4512517-XReport Type:Expedited (15-DaCompany Report #US_030493862 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Consumer Zyprexa-Oral Initial or Prolonged Anaemia Health (Olanzapine) PS 5 MG AT Other Atelectasis Professional BEDTIME Blood Potassium Increased Zestril (Lisinopril) C Coma Zoloft (Sertraline Cystitis Hydrochloride) C Effusion Aspirin C Fasciitis Desyrel (Trazodone Fungal Infection Hydrochloride) C Hepatic Steatosis Vioxx (Rofecoxib) C Hyperglycaemia Lopresor (Metorpolol Hypernatraemia Tartrate) C Hypoaesthesia Celebrex (Celecoxib) C Hypokalaemia Combivent C Laryngotracheo Bronchitis Pepcid (Famotidine) C Lung Infiltration Ultram (Tramadol Metabolic Encephalopathy Hydrochloride) C Packed Red Blood Cell Trazadone Transfusion (Trazodone) C Pancreatitis Pneumonia Renal Failure Acute Respiratory Failure Rhabdomyolysis Sputum Culture Positive Staphylococcal Bacteraemia Systemic Inflammatory Response Syndrome Tachycardia Thrombocytopenia Vaginal Discharge Vaginal Infection Date:11/24/04ISR Number: 4512518-1Report Type:Expedited (15-DaCompany Report #USA040979383 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Cymbalta (Duloxetine Other Medication Error Professional Hydrochloride) PS 60 MG DAY 2 WK Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG DAY 2 WK Date:11/24/04ISR Number: 4512527-2Report Type:Expedited (15-DaCompany Report #USA040875640 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Strattera(Atomoxetin Alcoholism Professional e Hydrochloride) PS 18 MG/1 DAY Physical Assault Company Zyprexa-Oral Thinking Abnormal Representative (Olanzapine) (Olanzapine) SS 40 MG AT BEDTIME Abilify (Aripiprazole) C 24-Jun-2005 12:19 PM Page: 3211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amitriptyline C Buspar (Buspirone Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Dilantin (Phenytoin) C Aciphex (Rabeprazole Sodium) C Lipitor (Aotrvastin Calcium) C Date:11/24/04ISR Number: 4512620-4Report Type:Expedited (15-DaCompany Report #USA041183707 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Zyprexa Professional (Olanzapine) PS INTRAMUSCULAR Date:11/24/04ISR Number: 4512666-6Report Type:Expedited (15-DaCompany Report #US_040410993 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Asthenia (Olanzapine) PS 45 MG/1 AT Back Pain BEDTIME Biliary Tract Disorder Prolixin Blood Cholesterol (Fluphenazine Abnormal Hydrochloride) C Body Temperature Artane Increased (Trihexyphenidyl Diabetes Mellitus Hydrochloride) C Diabetic Ketoacidosis Accupril (Quinapril Diarrhoea Hydrochloride) C Dysuria Asa (Acetylsalicylic Gastritis Acid) C General Physical Health Metroclopramide(Meto Deterioration clopramide Haematocrit Increased Hydrochloride) C Hypertension Dinphenoxylate Hyponatraemia W/Atropine Sulfate C Lipase Increased Atropine Malaise W/Hyoscine/Hyoscamin Oxygen Saturation e/Phenobarbital C Decreased Ultracet C Tachycardia Prozac (Fluoxetine Vision Blurred Hydrochloride) C Prilosec (Omeprazole Ratiopharm) C Date:11/24/04ISR Number: 4513919-8Report Type:Expedited (15-DaCompany Report #DSA_25380_2004 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Temesta PS ORAL DF Q DAY PO Initial or Prolonged Weight Decreased Health Cipralex SS ORAL 10 MG Q DAY Weight Increased Professional PO Other Nolvadex SS ORAL 20 MG Q DAY PO 24-Jun-2005 12:19 PM Page: 3212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Surmontil SS ORAL 75 MG Q DAY PO Surmontil SS ORAL 50 MG Q DAY PO Zyprexa SS ORAL 2.5 MG Q DAY PO Zyprexa SS ORAL 5 MG Q DAY PO Zyprexa SS ORAL 10 MG Q DAY PO Date:11/24/04ISR Number: 4514097-1Report Type:Expedited (15-DaCompany Report #US_0411108017 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Symbyax-Olanzapine / Convulsion Fluoxetine (Unknown Dose) (Ola PS Date:11/24/04ISR Number: 4514098-3Report Type:Expedited (15-DaCompany Report #USA041183296 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Overdose Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS Representative Klonopin (Clonazepam) C Date:11/24/04ISR Number: 4514117-4Report Type:Expedited (15-DaCompany Report #DSA_25374_2004 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Temesta PS ORAL DF Q DAY PO Initial or Prolonged Hyperhidrosis Health Magnesiocard SS ORAL DF PO Oedema Professional Mogadon SS ORAL 5 MG Q DAY PO Weight Increased Other Tegretol SS ORAL 800 MG Q DAY PO Zyprexa SS ORAL 30 MG Q DAY PO Zyprexa SS ORAL 25 MG Q DAY PO Zyprexa SS ORAL 20 MG Q DAY PO Zyprexa SS ORAL 15 MG Q DAY PO Zyprexa SS ORAL 10 MG Q DAY PO Eltroxin C Date:11/24/04ISR Number: 4514268-4Report Type:Expedited (15-DaCompany Report #CA_041007371 Age:45 YR Gender:Female I/FU:I Outcome PT Death Akathisia Hospitalization - Dysphagia Initial or Prolonged Dystonia Extrapyramidal Disorder 24-Jun-2005 12:19 PM Page: 3213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Pneumonia Aspiration Tardive Dyskinesia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) PS 10 MG 6 WK Professional Clonazepam C Company Propanolol C Representative Date:11/24/04ISR Number: 4514273-8Report Type:Expedited (15-DaCompany Report #GBS041115902 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Dilatation Foreign Olanzapine-Oral Other Sepsis Health (Olanzapine) PS 10 MG/2 DAY Professional Trazadone Other (Trazadone) C Tenormin (Atenolol) C Lipostat (Pravastatin Sodium) C Tritace (Ramipril) C Aspirin (Acetylsalicylic Acid) C Digoxin C Atrovent (Ipratropium Bromide) C Warfarin C Date:11/24/04ISR Number: 4514276-3Report Type:Expedited (15-DaCompany Report #EWC041141408 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS Disability Professional Zyloric Company (Allopurinol) C Representative Coumadin (Warfarin Other Sodium) C Date:11/24/04ISR Number: 4514278-7Report Type:Expedited (15-DaCompany Report #CA_041107417 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Male Foreign Zyprexa-Oral Hospitalization - Metastases To Lymph Nodes Health (Olanzapine) PS 15 MG Initial or Prolonged Professional Loxapac (Loxapine Company Succinate) C Representative Kemadrin Other (Procyclidine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/04ISR Number: 4514280-5Report Type:Expedited (15-DaCompany Report #DE_041114641 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Discomfort Foreign Zyprexa-Oral Hospitalization - Abdominal Pain Upper Health (Olanzapine) PS 7.5 MG DAY Initial or Prolonged Asthenia Professional Orfiril (Valproic Blood Uric Acid Increased Other Acid) C Cholestasis Orfiril-Slow Coagulopathy Release(Valproate Diarrhoea Sodium) C Feeling Abnormal Haldol Decanoate Gastric Disorder (Haloperidol Hepatic Encephalopathy Decanoate) C Hepatic Failure Fluxanol Depot Hepatic Function Abnormal (Flupetixol Hepatic Necrosis Decanoate) C Hepatocellular Damage Fluxanol Hepatomegaly (Fluxpentixol Hepatorenal Syndrome Decanoate) C Hyperkalaemia L-Thyroxin Lipase Abnormal (Levothyroxine Liver Transplant Sodium) C Mania Betoptima C Pallor Artelac Platelet Count Decreased (Hypromellose) C Pleural Effusion Divascan Transplant Rejection (Iprazochrome) C Vomiting Atosil (Isopromethazine Hydrochloride) C Diazepam C Date:11/24/04ISR Number: 4514282-9Report Type:Expedited (15-DaCompany Report #DE_030711712 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Zyprexa-Oral Initial or Prolonged Brain Oedema Health (Olanzapine) Other Cognitive Disorder Professional (Olanzapine) PS 10 MG DAY Crying Company Depressed Level Of Representative Consciousness Other Disturbance In Attention Drug Toxicity Grand Mal Convulsion Hypertonia Hyponatraemia Motor Dysfunction Muscle Twitching Pupillary Light Reflex Tests Abnormal Pyrexia Restlessness Rhabdomyolysis Stupor Vomiting 24-Jun-2005 12:19 PM Page: 3215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/04ISR Number: 4514322-7Report Type:Expedited (15-DaCompany Report #DE_041114658 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zyprexa-Oral Initial or Prolonged Dyspnoea Health (Olanzapine) Electrocardiogram Professional (Olanzapine) PS 15 MG DAY 6 MON Abnormal Other L-Thyroxin Fatigue (Levothyroxine Sodium) C Date:11/24/04ISR Number: 4514346-XReport Type:Expedited (15-DaCompany Report #GBS041115905 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Olanzapine-Oral Hospitalization - Phosphokinase Increased Health (Olanzapine) PS 10 MG Initial or Prolonged Cardiogenic Shock Professional Diazepam C Other Congestive Cardiomyopathy Other Promazine C Hepatic Failure Dothiepin C Hepatic Necrosis Zopiclone (Zopiclone) C Amoxycillin C Quinine Sulphate C Date:11/24/04ISR Number: 4514350-1Report Type:Expedited (15-DaCompany Report #AU_041108163 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa-Rapid-Acting Sleep Apnoea Syndrome Health Im (Olanzapine) PS OTHER 10 MG OTHER Professional Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) SS 10 MG AS Other NEEDED Lorazepam C Quetiapine C Lithium Carbonate C Lorazepam C Zopiclone (Zopiclone) C Date:11/24/04ISR Number: 4514351-3Report Type:Expedited (15-DaCompany Report #FR_040904889 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Zyprexa-Oral Initial or Prolonged C-Reactive Protein Health (Olanzapine) Other Increased Professional (Olanzapine) PS 7.5 MG DAY Leukopenia Other Pyrexia Sepsis Syndrome 24-Jun-2005 12:19 PM Page: 3216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/04ISR Number: 4514353-7Report Type:Expedited (15-DaCompany Report #CA_040907271 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Foreign Olanzapine-Oral Blood Chloride Decreased Study (Olanzapine) PS 15 MG IN THE Blood Cholesterol Health EVENING Increased Professional Epival (Valproate Blood Sodium Decreased Other Semisodium) SS 1500 MG IN Chest Discomfort THE EVENING Drug Level Increased Clonazepam C Fungal Rash Zopiclone Insomnia (Zopiclone) C Laboratory Test Abnormal Losec (Omeprazole Low Density Lipoprotein Magnesium) C Increased Vioxx (Rofecoxib) C Restless Legs Syndrome Date:11/24/04ISR Number: 4514363-XReport Type:Expedited (15-DaCompany Report #EWC041141409 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa-Rapid-Acting Initial or Prolonged Syndrome Health Im (Olanzapine) PS 2 DSG FORM/2 Professional DAY Company Zinacef (Cefuroxime Representative Sodium) C Other Polibar (Barium Sulfate) C Zeldox (Ziprasidone (Ziprasidone Hydrochloride) C Haloperidol C Akineton (Biperiden Lactate) C Ciprobay (Ciprofloxacin Hydrochloride) C Paxirasol (Bromhexine Hydrochloride) C Rivotril (Clonazepam) C Augmentin C Leponex (Clozapine) C Date:11/24/04ISR Number: 4514376-8Report Type:Expedited (15-DaCompany Report #FR_040904890 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Confusional State Health (Olanzapine) Hypercapnia Professional (Olanzapine) PS Lung Disorder Other Xanax (Alprazolam Malnutrition Dum) C Mental Disorder Mopral (Omeprazole Rales Ratiopharm) C Somnolence Effexor (Venlafaxine Superinfection Lung Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/04ISR Number: 4515412-5Report Type:Expedited (15-DaCompany Report #2004079238 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Professional Olanzapine Company (Olanzapine) SS 5 MG Representative Drug, Unspecified (Drug, Unspecified) SS Haloperidol Decanoate (Haloperidol Decanoate) C Date:11/29/04ISR Number: 4511564-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12716692 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Depakote I Zyprexa I Date:11/29/04ISR Number: 4516001-9Report Type:Expedited (15-DaCompany Report #2004094537 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Alprazolam Tablet Initial or Prolonged Hypercapnia Health (Alprazolam) PS ORAL ORAL Lung Disorder Professional Omeprazole Malnutrition (Omeprazole) SS ORAL ORAL Rales Venlafaxine Somnolence (Venlafaxine) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Date:11/29/04ISR Number: 4525976-3Report Type:Periodic Company Report #USA040568686 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Blood Glucose Increased (Olanzapine) Other (Olanzapine) PS 10 MG DAY Date:11/29/04ISR Number: 4525994-5Report Type:Periodic Company Report #USA040568709 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 60 MG 88 DAY Representative Geodon (Ziprasidone Hydrochloride) C Lexapro (Escitalopram) C Wellbutrin (Bupropion 24-Jun-2005 12:19 PM Page: 3218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Risperidone C Date:11/29/04ISR Number: 4525996-9Report Type:Periodic Company Report #USA040568653 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Zyprexa-Oral Initial or Prolonged Congestive Professional (Olanzapine) Fluid Retention Company (Olanzapine) PS 5 MG 4 WK Representative Ditropan (Oxybutynin) C Date:11/29/04ISR Number: 4525997-0Report Type:Periodic Company Report #USA040568461 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Symbyax-Olanzapine Initial or Prolonged Gastritis Professional 6mg / Fluoxetine Irritable Bowel Syndrome Company 25mg (Olanzapin PS Sinusitis Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/2 DAY Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG/1 DAY Xanax (Alprazolam) C Depakote (Valproate Semisodium) C Date:11/29/04ISR Number: 4525998-2Report Type:Periodic Company Report #USA040568303 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Dispersible Initial or Prolonged Syndrome Professional (Olanzapine) Other Company (Olanzapine) PS 20 MG DAY Representative Depakote (Valproate Semisodium) C Date:11/29/04ISR Number: 4525999-4Report Type:Periodic Company Report #USA040979158 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Zyprexa-Oral Initial or Prolonged Prescribed Overdose (Olanzapine) Suicidal Ideation (Olanzapine) PS 40 MG DAY Depakote (Valproate Semisodium) C Date:11/29/04ISR Number: 4526000-9Report Type:Periodic Company Report #USA040979162 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Zyprexa-Oral Other Death (Olanzapine) 24-Jun-2005 12:19 PM Page: 3219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS Metronidazole C Topiramate C Clonazepam C Date:11/29/04ISR Number: 4526002-2Report Type:Periodic Company Report #USA040978997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Symbyax-Olanzapine Initial or Prolonged Professional 6mg/ Fluoxetine 25mg Company (Olanzapin PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/1 DAY Zoloft (Sertraline Hydrochloride) C Date:11/29/04ISR Number: 4526003-4Report Type:Periodic Company Report #USA040979027 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Weight Increased (Olanzapine) (Olanzapine) PS Date:11/29/04ISR Number: 4526006-XReport Type:Periodic Company Report #USA040978694 Age:6 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Health Zyprexa-Oral Initial or Prolonged Fluctuation Professional (Olanzapine) Other Convulsion (Olanzapine) PS Parkinsonism Prescribed Overdose Date:11/29/04ISR Number: 4526007-1Report Type:Periodic Company Report #USA040978742 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Zyprexa-Oral Initial or Prolonged Medication Error Professional (Olanzapine) (Olanzapine) PS 10 MG Date:11/29/04ISR Number: 4526009-5Report Type:Periodic Company Report #USA040978772 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Consumer Zyprexa-Oral Initial or Prolonged Blood Pressure (Olanzapine) Disability Fluctuation (Olanzapine) PS 5 MG 1 YR Blood Pressure Increased Neurontin Dysphagia (Gabapentin) C Insomnia Aricept (Donepezil) C Mental Disorder Vioxx (Rofecoxib) C Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526012-5Report Type:Periodic Company Report #USA040978800 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hospitalisation Consumer Zyprexa-Oral Hospitalization - Intentional Misuse (Olanzapine) Initial or Prolonged (Olanzapine) PS 20 MG Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 40 MG Trilafon (Perphenazine) C Klonopin (Clonazepam) C Fosamax (Alendronate Sodium) C Geodon (Ziprasidone Hydrochloride) C Date:11/29/04ISR Number: 4526013-7Report Type:Periodic Company Report #USA040978843 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/29/04ISR Number: 4526015-0Report Type:Periodic Company Report #USA040978597 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Other Syndrome Professional (Olanzapine) Company (Olanzapine) PS 10 MG/1 DAY Representative Date:11/29/04ISR Number: 4526018-6Report Type:Periodic Company Report #USA040978460 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Abnormal Consumer Zyprexa-Oral Hospitalization - Diabetes Mellitus (Olanzapine) PS Initial or Prolonged Pancreatitis Date:11/29/04ISR Number: 4526019-8Report Type:Periodic Company Report #USA040978490 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombotic Stroke Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS 7.5 MG AT Other Company BEDTIME 10 MON Representative Celexa (Citalopram Hydrobromide) C 24-Jun-2005 12:19 PM Page: 3221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526020-4Report Type:Periodic Company Report #USA040978178 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS 2.5 MG DAY Company Xanax (Alprazolam Representative Dum) C Date:11/29/04ISR Number: 4526022-8Report Type:Periodic Company Report #USA040978273 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Zyprexa-Oral Initial or Prolonged Blood Glucose Increased Professional (Olanzapine) PS 15 MG DAY Emphysema Company Representative Date:11/29/04ISR Number: 4526023-XReport Type:Periodic Company Report #USA040978292 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Consumer Zyprexa-Oral Hospitalization - Full Blood Count (Olanzapine) PS Initial or Prolonged Decreased Risperidone C Haematochezia Weight Increased Date:11/29/04ISR Number: 4526024-1Report Type:Periodic Company Report #USA040978132 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Health Zyprexa-Oral Initial or Prolonged Convulsion Professional (Olanzapine) PS 20 MG Company Wellbutrin Representative (Bupropion Hydrochloride) C Date:11/29/04ISR Number: 4526025-3Report Type:Periodic Company Report #USA040978139 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Zyprexa-Oral Congestive Company (Olanzapine) PS 10 MG Representative Lipitor (Torvastatin C Actos (Pioglitazone Hydrochloride) C Glucovance C Lisinopril 9lisinopril) C Coumadin (Warfarin Sodium) C Eskalith (Lithium Carbonate) C 24-Jun-2005 12:19 PM Page: 3222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526026-5Report Type:Periodic Company Report #USA040977824 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Zyprexa-Oral Initial or Prolonged Weight Increased Professional (Olanzapine) PS 20 MG DAY Other Company Representative Date:11/29/04ISR Number: 4526028-9Report Type:Periodic Company Report #USA040977275 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa-Oral Initial or Prolonged Insomnia Professional (Olanzapine) PS Intentional Misuse Prozac-Oral Pyrexia (Fluoxetine) Swelling (Fluoxetine Thirst Hydrochloride) SS Prozac (Fluoxetine Hydrochloride) C Date:11/29/04ISR Number: 4526030-7Report Type:Periodic Company Report #USA040977198 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS 2.5 MG Company Representative Date:11/29/04ISR Number: 4526032-0Report Type:Periodic Company Report #USA040977152 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa-Oral Initial or Prolonged Hypertension Professional (Olanzapine) Speech Disorder (Olanzapine) PS 5 MG/1 DAY Staring Lithium C Vomiting Date:11/29/04ISR Number: 4526034-4Report Type:Periodic Company Report #USA040977101 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 10 MG Representative Symbyax-Olanzapine 6mg / Fluoxetine 25 Mg (Olanzapin SS 24-Jun-2005 12:19 PM Page: 3223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526035-6Report Type:Periodic Company Report #USA040877023 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa-Oral Initial or Prolonged Cardiac Failure (Olanzapine) Other Congestive (Olanzapine) PS Oedema Peripheral Digoxin (Digoxin) C Pancreatitis Monopril (Fosinopril Sodium) C Furosemide C Klor-Con (Potassium Chloride) C Warfarin C Levaquin (Levofloxacin) C Date:11/29/04ISR Number: 4526037-XReport Type:Periodic Company Report #USA040877003 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Consumer Zyprexa-Oral Initial or Prolonged Weight Increased (Olanzapine) (Olanzapine) PS Date:11/29/04ISR Number: 4526038-1Report Type:Periodic Company Report #USA040876949 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa-Oral Initial or Prolonged Dizziness (Olanzapine) Hallucination (Olanzapine) PS Nausea Celexa (Citolapram Hydrochloride) C Depakote (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Synthroid (Levothyroxine Sodium) C Buspirone C Date:11/29/04ISR Number: 4526040-XReport Type:Periodic Company Report #USA040876682 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other (Olanzapine) PS 15 MG Celexa (Citalopram Hydrobromide) C Levoxyl (Levothyroxine) C Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 3224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Perphenazine C Date:11/29/04ISR Number: 4526041-1Report Type:Periodic Company Report #USA040876475 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Depakote (Valproate Semisodium) C Date:11/29/04ISR Number: 4526043-5Report Type:Periodic Company Report #USA040876180 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Health Zyprexa-Oral Initial or Prolonged Pancreatitis Professional (Olanzapine) Prescribed Overdose Company (Olanzapine) PS 10 MG/3 DAY Representative Date:11/29/04ISR Number: 4526044-7Report Type:Periodic Company Report #USA040876082 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Consumer Zyprexa-Oral Initial or Prolonged Hypersomnia (Olanzapine) Other Overdose (Olanzapine) PS 10 MG IN THE EVENING Depakote (Valproate Semisodium) C Date:11/29/04ISR Number: 4526045-9Report Type:Periodic Company Report #USA040875768 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Somnolence Health Zyprexa-Oral Initial or Prolonged Suicide Attempt Professional (Olanzapine) Company (Olanzapine) PS Representative Paxil (Paroxetine Hydrochloride) C Date:11/29/04ISR Number: 4526046-0Report Type:Periodic Company Report #USA040875320 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa-Oral Initial or Prolonged Syndrome Professional (Olanzapine) Other Prescribed Overdose Company (Olanzapine) PS 30 MG Representative Prolixin (Fluphenazine Hydrochloride) C Haldol (Haloperidol Deconoate) C 24-Jun-2005 12:19 PM Page: 3225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526048-4Report Type:Periodic Company Report #USA040875334 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antidepressant Drug Level Consumer Zypexa-Oral Initial or Prolonged Increased (Olanzapine) Anxiety (Olanzapine) PS 10 MG DAY Blood Glucose Increased Prozac-Oral Depression (Fluoxetine) Hallucinations, Mixed (Fluoxetine Mental Impairment Hydrochloride) SS 80 MG IN THE Nocturia MORNING Weight Increased Lexapro (Escitalopram Oxalate) C Abilify (Aripiprazole) C Ambien (Zolpidem Tartrate) C Vioxx (Rofecoxib) C Duragesic (Fentanyl) C Ritalin (Methylphenidate Hydrochloride) C Date:11/29/04ISR Number: 4526050-2Report Type:Periodic Company Report #USA040875360 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Gland Injury Consumer Zyprexa-Oral Initial or Prolonged Coma (Olanzapine) Other (Olanzapine) PS Date:11/29/04ISR Number: 4526051-4Report Type:Periodic Company Report #USA040875041 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Consumer Zyprexa-Oral Initial or Prolonged Belligerence (Olanzapine) Difficulty In Walking (Olanzapine) PS 20 MG AT Fall BEDTIME Hallucination, Auditory Weight Increased Wound Date:11/29/04ISR Number: 4526053-8Report Type:Periodic Company Report #USA040874979 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Suicide Attempt Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Fluoxetine-Oral (Fluoxetine) (Fluoxetine Hydrochlor SS 20 MG Flonase (Fluticasone Propionate) C Allegra-D C 24-Jun-2005 12:19 PM Page: 3226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Lithobid (Lithium Carbonate) C Ambien (Zolpidem Tartrate) C Date:11/29/04ISR Number: 4526054-XReport Type:Periodic Company Report #USA040874742 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Zyprexa-Oral Initial or Prolonged Overdose (Olanzapine) Prescribed Overdose (Olanzapine) PS 30 MG Restlessness Ativan (Lorazepam) C Lithium C Propanolol C Date:11/29/04ISR Number: 4526056-3Report Type:Periodic Company Report #USA040874662 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) Company (Olanzapine) PS 10 MG/L DAY Representative Divalproex Sodium C Date:11/29/04ISR Number: 4526058-7Report Type:Periodic Company Report #USA040874404 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS 2.5 MG/2 DAY Asa (Acetylsalicylic Acid) C Date:11/29/04ISR Number: 4526060-5Report Type:Periodic Company Report #USA040774117 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Consumer Zyprexa-Oral Initial or Prolonged Congestive (Olanzapine) Other Mental Disorder (Olanzapine) PS Swelling Date:11/29/04ISR Number: 4526061-7Report Type:Periodic Company Report #USA040774086 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Consumer Zyprexa-Oral Initial or Prolonged Company (Olanzapine) Other Representative (Olanzapine) PS 10 MG 24-Jun-2005 12:19 PM Page: 3227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526062-9Report Type:Periodic Company Report #USA040774066 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 15 MG DAY Representative Stelazine (Trifluoprazine Hydrochloride) C Prolixin Decanoate (Fluphenazine Decanoate) C Date:11/29/04ISR Number: 4526063-0Report Type:Periodic Company Report #USA040773931 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa-Oral Initial or Prolonged Prescribed Overdose (Olanzapine) (Olanzapine) PS 50 MG DAY Geodon (Ziprasidone Hydrochloride) C Depakote (Valproate Semisodium) C Atenolol C Date:11/29/04ISR Number: 4526064-2Report Type:Periodic Company Report #USA040773801 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 10 MG Representative Date:11/29/04ISR Number: 4526065-4Report Type:Periodic Company Report #USA040773496 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Pain (Olanzapine) (Olanzapine) PS Date:11/29/04ISR Number: 4526067-8Report Type:Periodic Company Report #USA040772674 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Other Nausea Company (Olanzapine) PS 20 MG/1 DAY Vomiting Representative Navane (Tiotixene) C 24-Jun-2005 12:19 PM Page: 3228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526069-1Report Type:Periodic Company Report #USA040772550 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Consumer Zyprexa-Oral Initial or Prolonged Increased Appetite (Olanzapine) Oedema (Olanzapine) PS 7.5 MG DAY Somnolence Gabitril (Titagabine Tachycardia Hydrochloride) C Tremor Lexapro Weight Increased (Escitalopram Oxalate) C Vioxx (Rofecoxib) C Toradol (Ketorolac Tromethamine) C Sonata (Zaleplon) C Date:11/29/04ISR Number: 4526071-XReport Type:Periodic Company Report #USA040772507 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine) Fatigue (Olanzapine) PS 20 MG DAY Impulse-Control Disorder Paxil (Paroxetine Keratoconjunctivitis Hydrochloride) C Sicca Mental Impairment Panic Attack Personality Disorder Sensory Disturbance Social Avoidant Behaviour Speech Disorder Thinking Abnormal Weight Decreased Date:11/29/04ISR Number: 4526074-5Report Type:Periodic Company Report #USA040772035 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative Date:11/29/04ISR Number: 4526076-9Report Type:Periodic Company Report #USA040771985 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Prescribed Overdose Professional (Olanzapine) Company (Olanzapine) PS 45 MG Representative Depakote (Valproate Semisodium) C Loxitane (Loxapine) C Apo-Metoprolol (Metoprolol Tartrate) C Insulin C 24-Jun-2005 12:19 PM Page: 3229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526077-0Report Type:Periodic Company Report #USA040771943 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Prescribed Overdose (Olanzapine) Weight Increased (Olanzapine) PS 20 MG/2 DAY 2 YR Date:11/29/04ISR Number: 4526079-4Report Type:Periodic Company Report #USA040771835 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Drug Ineffective (Olanzapine) (Olanzapine) PS 5 MG DAY Celebrex (Celecoxib) C Fosamax (Alendronate Sodium) C Escitalopram C Procrit (Erythropoietin) C Date:11/29/04ISR Number: 4526080-0Report Type:Periodic Company Report #USA040771727 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Date:11/29/04ISR Number: 4526081-2Report Type:Periodic Company Report #USA040771565 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Weight Decreased Professional (Olanzapine) Other Company (Olanzapine) PS 10 MG/1 DAY 3 MON Representative Date:11/29/04ISR Number: 4526082-4Report Type:Periodic Company Report #USA040671371 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Zyprexa-Oral Initial or Prolonged Blood Glucose Increased (Olanzapine) Other Cerebrovascular Accident (Olanzapine) PS 10 MG/2 DAY Embolism Nexium (Esomeprazole Feeling Abnormal Magnesium) C Nausea Prevacid Pain (Lansoprazole) C Somnolence Xanax (Alprazolam Dum) C 24-Jun-2005 12:19 PM Page: 3230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526083-6Report Type:Periodic Company Report #USA040671445 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative Date:11/29/04ISR Number: 4526084-8Report Type:Periodic Company Report #USA040671024 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Pneumonia (Olanzapine) Weight Increased (Olanzapine) PS 20 MG/1 AT BEDTIME Klonopin (Clonazepam) C Buspirone C Ambien (Zolpidem Tartrate) C Trazadone (Trazodone) C Geodon (Ziprasidone Hydrochloride) C Date:11/29/04ISR Number: 4526085-XReport Type:Periodic Company Report #USA040670913 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Consumer Zyprexa-Oral Initial or Prolonged Orthostatic (Olanzapine) Feeling Abnormal (Olanzapine) PS 10 MG DAY Captopril C Wellbutrin (Bupropion Hydrochloride) C Buspar (Buspirone Hydrochloride) C Trazodone C Aspirin (Acetylsalicylic Acid) C Plavix (Clopidogrel Sulfate) C Nexium (Esomeprazole Magnesium) C Lipitor (Atorvastatin) C Flexeril (Cyclobenzaprine Hydrochloride) C Vicodin C Phenergan (Promethazine Hydrochloride) C Meclizine C 24-Jun-2005 12:19 PM Page: 3231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4526086-1Report Type:Periodic Company Report #USA040670760 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Balance Disorder (Olanzapine) Other Musculoskeletal Stiffness (Olanzapine) PS 20 MG/1 DAY Neuroleptic Malignant Symbyax-Olanzapine Syndrome 6mg / Fluoxetine 25mg (Olanzapine) SS Depakote (Valproate Semisodium) C Dilantin (Phenytoin Sodium) C Date:11/29/04ISR Number: 4526087-3Report Type:Periodic Company Report #USA040670777 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Somnolence Professional (Olanzapine) Suicide Attempt Company (Olanzapine) PS 10 MG DAY Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG DAY Date:11/29/04ISR Number: 4526088-5Report Type:Periodic Company Report #USA040670541 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 15 MG/1 DAY 7 YR Representative Date:11/29/04ISR Number: 4527039-XReport Type:Periodic Company Report #USA040465901 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Drug Ineffective (Olanzapine) Middle Insomnia (Olanzapine) PS 15 MG/1 DAY Bextra (Valdecoxib) C Norvasc (Amlodipine Besilate) C Lasix (Furosemide) C Aricept (Donepezil Hydrochloride) C Altace (Ramipril) C Vitamins C Date:11/29/04ISR Number: 4527042-XReport Type:Periodic Company Report #USA040465736 Age:63 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Convulsion 24-Jun-2005 12:19 PM Page: 3232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Sedation Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa Professional Zydis-Dispersible Company (Olanzapine) Representative (Olanzapine) PS 15 MG DAY Date:11/29/04ISR Number: 4527043-1Report Type:Periodic Company Report #USA040465467 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine PS 140 MG DAY Representative Valium (Diazepam) C Date:11/29/04ISR Number: 4527044-3Report Type:Periodic Company Report #USA040465468 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Insulin-Dependent Professional (Olanzapine) Other Diabetic Ketoacidosis (Olanzapine) PS 30 MG AT Prescribed Overdose BEDTIME Weight Decreased Depakene (Valproate Weight Increased Sodium) C Date:11/29/04ISR Number: 4527045-5Report Type:Periodic Company Report #USA040465113 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa-Oral Hospitalization - Drug Ineffective Professional (Olanzapine) Initial or Prolonged Paranoia (Olanzapine) PS 20 MG/3 DAY 2 YR Prescribed Overdose Zyprexa Suicide Attempt Zydis-Dispersible (Olanzapine) (Olanzapine) SS 20 MG/4 DAY Lorazepam C Abilify (Aripiprazole) C Lamictal (Lamotrigine) C Date:11/29/04ISR Number: 4527047-9Report Type:Periodic Company Report #USA040464792 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa-Oral Initial or Prolonged Psychotic Disorder Professional (Olanzapine) Other Company (Olanzapine) PS 20 MG Representative Anti-Diabetic C Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4527049-2Report Type:Periodic Company Report #USA040463883 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Consumer Zyprexa-Oral Hospitalization - Depression (Olanzapine) Initial or Prolonged Overdose (Olanzapine) PS Depakote (Valproate Semisodium) C Date:11/29/04ISR Number: 4527050-9Report Type:Periodic Company Report #USA040463789 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Health Zyprexa-Oral Initial or Prolonged Weight Increased Professional (Olanzapine) (Olanzapine) PS Viramune (Nevirapine) C Klonopin (Clonazepam) C Date:11/29/04ISR Number: 4527054-6Report Type:Periodic Company Report #USA040463704 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Symbyax-Olanzapine / Initial or Prolonged Professional Fluoxetine (Unknown Other Company Dose) (Olanzapine) PS Representative Olanzapine-Oral (Olanzapine) SS Date:11/29/04ISR Number: 4527055-8Report Type:Periodic Company Report #USA040463740 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Depressed Level Of (Olanzapine) Other Consciousness (Olanzapine) PS 2.5 MG/1 DAY 5 DAY Head Injury Zoloft (Sertraline Intentional Misuse Hydrochloride) C Lethargy Memory Impairment Neck Pain Neuroleptic Malignant Syndrome Date:11/29/04ISR Number: 4527071-6Report Type:Periodic Company Report #USA040363386 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Health Zyprexa-Dispersible Initial or Prolonged Oedema Peripheral Professional (Olanzapine) Company (Olanzapine) PS 15 MG DAY Representative High Blood Pressure Medication C Diuretic C Haldol (Haloperidol) C 24-Jun-2005 12:19 PM Page: 3234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4527072-8Report Type:Periodic Company Report #USA040362344 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged (Olanzapine) PS Other Date:11/29/04ISR Number: 4527073-XReport Type:Periodic Company Report #USA040362395 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Company Zyprexa-Oral Weight Increased Representative (Olanzapine) (Olanzapine) PS Date:11/29/04ISR Number: 4527074-1Report Type:Periodic Company Report #USA040360978 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Company (Olanzapine) PS 20 MG/AT Representative BEDTIME Haldol (Haloperidol) C Ativan (Lorazepam) C Date:11/29/04ISR Number: 4527075-3Report Type:Periodic Company Report #USA040360781 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa-Oral Initial or Prolonged Decreased Professional (Olanzapine) Disability Blood Iron Decreased (Olanzapine) PS 50 MG/1 AT Other Convulsion BEDTIME Dyspnoea Cogentin Haematocrit Decreased (Benzatropine Haemoglobin Decreased Mesilate) C Hyponatraemia Vitamin E C Prescribed Overdose Multivitamin C Red Blood Cell Count Synthroid Decreased (Levothyroxine Sodium) C Casanthranol W/Docusate Sodium C Haldol (Haloperidol) C Paxil (Paroxetine Hydrochloride) C Date:11/29/04ISR Number: 4527076-5Report Type:Periodic Company Report #USA040260419 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Zyprexa-Oral Hospitalization - Syndrome Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 5 MG/1 IN THE Representative EVENING 3 YR 24-Jun-2005 12:19 PM Page: 3235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Promethazine C Vistaril (Hydroxyzine Embonate) C Buspar (Buspirone Hydrochloride) C Celebrex (Celecoxib) C Lexapro (Escitalopram) C Desyrel (Trazodone Hydrochloride) C Methadone C Skelaxin (Metaxalone) C Date:11/29/04ISR Number: 4527077-7Report Type:Periodic Company Report #USA040260334 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 15 MG/DAY Representative Topamax (Topiramate) C Date:11/29/04ISR Number: 4527078-9Report Type:Periodic Company Report #USA040260154 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 7.5 MG/3 DAY Representative Date:11/29/04ISR Number: 4527079-0Report Type:Periodic Company Report #USA040259939 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Zyprexa-Oral Hospitalization - Intentional Misuse Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 5 MG/DAY Representative Premarin (Estrogens Conjugated) C Lasix (Furosemide) C K-Dur (Potassium Chloride) C Synthroid (Levothyroxine Sodium) C Vioxx (Rofecoxib) C Coumadin (Warfarin Sodium) C Zaroxolyn (Metolazone) C Morphine C Vitamin B12 C Hyzaar C 24-Jun-2005 12:19 PM Page: 3236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4527080-7Report Type:Periodic Company Report #USA040259216 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Prozac-Oral Hospitalization - Weight Increased Professional (Fluoxetine) Initial or Prolonged Company (Fluoxetine Representative Hydrochloride) PS 20 MG/DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG/DAY Seroquel (Quetiapine Fumarate) C Topamax (Topiramate) C Protonix (Pantoprazole) C Depo Provera (Medroxyprogesterone Acetate) C Klonopin (Clonazepam) C Date:11/29/04ISR Number: 4527081-9Report Type:Periodic Company Report #USA021022802 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Health Zyprexa- Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS Propylthiouracil C Zoloft (Sertraline Hydrochloride) C Celebrex (Celecoxib) C Colace (Docusate Sodium) C Aspirin C Acetaminophen C Date:11/29/04ISR Number: 4527082-0Report Type:Periodic Company Report #USA020921310 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Zyprexa-Oral Initial or Prolonged Convulsion Professional (Olanzapine) Electroencephalogram Company (Olanzapine) PS 2.5 MG/DAY 1 WK Abnormal Representative Wellbutrin (Amfebutamone Hydrochloride) C Wellbutrin Sr (Bupriopion Hydrochloride) C Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4527083-2Report Type:Periodic Company Report #USA020414476 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus (Olanzapine) Disability Suicidal Ideation (Olanzapine) PS Weight Decreased Paxil (Paroxetine Hydrochloride) C Concerta (Methylphenidate Hydrochloride) C Date:11/29/04ISR Number: 4527084-4Report Type:Periodic Company Report #USA040157008 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Oral Initial or Prolonged Agitation Professional (Olanzapine) Alanine Aminotransferase (Olanzapine) PS 1000 MG Increased Valproic Acid C Aspartate Paxil (Paroxetine Aminotransferase Hydrochloride) C Increased Body Temperature Increased Hypotension Intentional Misuse Mental Impairment Prescribed Overdose Tachycardia White Blood Cell Count Decreased Date:11/29/04ISR Number: 4527085-6Report Type:Periodic Company Report #USA031255071 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Health Zyprexa-Oral Initial or Prolonged Priapism Professional (Olanzapine) (Olanzapine) PS 10 MG/2 DAY Paxil (Paroxetine Hydrochloride) C Remeron (Mirtazapine) C Date:11/29/04ISR Number: 4527086-8Report Type:Periodic Company Report #USA031050462 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Consumer Zyprexa-Oral Initial or Prolonged Drug Hypersensitivity (Olanzapine) Dyspnoea (Olanzapine) PS 10 MG AT Dystonia BEDTIME Hallucination, Auditory Benadryl Headache (Diphenhydramine Lethargy Hydrochloride) C Mood Swings Vicodin C Somnolence Ambien (Zolpidem 24-Jun-2005 12:19 PM Page: 3238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) C Depakote (Valproate Semisodium) C Multivitamins Nos (Multivitamins Nos) C Clonazepam C Anxiety C Atenolol C Dilantin (Phenytoin Sodium) C Date:11/29/04ISR Number: 4527087-XReport Type:Periodic Company Report #USA030741332 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) Other Delirium (Olanzapine) PS 450 MG Loss Of Consciousness Overdose Pyrexia Tachycardia Date:11/29/04ISR Number: 4527088-1Report Type:Periodic Company Report #USA030536639 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine)(Olanzap Weight Increased ine) PS 10 MG/DAY Metformin C Unknown Diabetes Medication C Date:11/29/04ISR Number: 4527089-3Report Type:Periodic Company Report #USA030536591 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Zyprexa-Oral Initial or Prolonged Suicide Attempt Professional (Olanzapine) Company (Olanzapine) PS 2.5 MG Representative Date:11/29/04ISR Number: 4527090-XReport Type:Periodic Company Report #USA030435237 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus (Olanzapine)(Olanzap Other Hallucination, Auditory ine) PS 30 MG/DAY Prescribed Overdose Zyprexa Weight Increased Zydis-Dispersible (Olanzapine) (Olanzapine) SS 30 MG/DAY 3 WK Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Paxil (Paroxetine 24-Jun-2005 12:19 PM Page: 3239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Wellbutrin (Bupropion Hydrchloride) C Haldol (Haloperidol) C Date:11/29/04ISR Number: 4527091-1Report Type:Periodic Company Report #USA040567629 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Other Hyperglycaemia Company (Olanzapine) PS 20 MG Lethargy Representative Date:11/29/04ISR Number: 4527092-3Report Type:Periodic Company Report #USA040567412 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Consumer Zyprexa-Oral Hospitalization - Diabetic Coma (Olanzapine) Initial or Prolonged Hyperglycaemia (Olanzapine) PS 20 MG DAY Other Depakote (Valproate Semisodium) C Lisinopril (Lisinopril) C Felodipine C Naproxen (Naproxen Sodium) C Allopurinol C Synthroid (Levothyroxine Sodium) C Aspirin (Acetylsalicylic Acid) C Propanolol C Date:11/29/04ISR Number: 4527093-5Report Type:Periodic Company Report #USA040567396 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Other Blood Glucose Increased Company (Olanzapine) PS 60 MG DAY Blood Triglycerides Representative Lorazepam C Increased Increased Appetite Prescribed Overdose Weight Increased Date:11/29/04ISR Number: 4527094-7Report Type:Periodic Company Report #USA040567263 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Blindness Other Blood Glucose Increased 24-Jun-2005 12:19 PM Page: 3240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Diabetes Mellitus Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Pain Consumer Prozac-Oral Vision Blurred (Fluoxetine) Weight Increased (Fluoxetine Hydrochloride) PS 80 MG/DAY 6 YR Humulin-Human(Rdna): 30% Regular, 70% Nph (H SS 78 U DAY Humalog-.(Lispro) SS Zyprexa-Oral (Olanzapine) (Olanzapine) SS Dilantin (Phenytoin Sodium) C Tegretol (Carbamazepine) C Risperidone C Ativan (Lorazepam) C Vioxx (Rofecoxib) C Centrum A To Zinc C Date:11/29/04ISR Number: 4527095-9Report Type:Periodic Company Report #USA040567106 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Prescribed Overdose Professional (Olanzapine) Other Company (Olanzapine) PS 25 MG/EVERY Representative AT BEDTIME Topamax (Topiramate) C Zoloft (Sertraline Hydrochloride) C Tegretol (Carbamazepine) C Date:11/29/04ISR Number: 4527096-0Report Type:Periodic Company Report #USA040566989 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Consumer Zyprexa-Oral Initial or Prolonged Weight Increased (Olanzapine) (Olanzapine) PS Lithium C Zoloft (Sertraline Hydrochloride) C Date:11/29/04ISR Number: 4527097-2Report Type:Periodic Company Report #USA040567043 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Hyperglycaemia Professional (Olanzapine) Mania Company (Olanzapine) PS 20 MG/3 DAY Prescribed Overdose Representative Lithium C 24-Jun-2005 12:19 PM Page: 3241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4527098-4Report Type:Periodic Company Report #USA040567057 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Zyprexa-Oral Initial or Prolonged Musculoskeletal Stiffness (Olanzapine) Other Nervousness (Olanzapine) PS 2.5 MG Paralysis Xanax (Alprazolam) C Date:11/29/04ISR Number: 4527099-6Report Type:Periodic Company Report #USA040566945 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Other Prescribed Overdose Company (Olanzapine) PS 40 MG DAY Representative Date:11/29/04ISR Number: 4527100-XReport Type:Periodic Company Report #USA040566861 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Weight Increased Professional (Olanzapine) Company (Olanzapine) PS Representative Date:11/29/04ISR Number: 4528041-4Report Type:Periodic Company Report #US_991029935 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Insulin-Dependent Professional (Olanzapine) PS 20 MG/DAY Mania Depakote (Valproate Polydipsia Semisodium) C Polyuria Klonopin Vomiting (Clonazepam) C Lamictal (Lamotrigine) C Celexa (Citalopram Hydrobromide) C Date:11/29/04ISR Number: 4528043-8Report Type:Periodic Company Report #US_0409106125 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/29/04ISR Number: 4528044-XReport Type:Periodic Company Report #US_0409106145 Age:34 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 3242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Health Zyprexa-Oral Loss Of Consciousness Professional (Olanzapine) Road Traffic Accident (Olanzapine) PS Abilify (Aripiprazole) C Date:11/29/04ISR Number: 4528049-9Report Type:Periodic Company Report #US_0409105193 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Abnormal Consumer Humulin-Human Initial or Prolonged Blood Glucose Increased Insulin (Rdna): 30% Other Diabetes Mellitus Regular, 70% Nph (H PS 50 U DAY Hypertension Zyprexa-Oral Retinitis (Olanzapine) Visual Disturbance (Olanzapine) SS Weight Increased Depakote (Valproate Semisodium) C Lithium C Metformin C Lisinopril (Lisinopril) C Lescol (Fluvastatin) C Date:11/29/04ISR Number: 4528052-9Report Type:Periodic Company Report #US_0409105461 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) (Olanzapine) PS 5 MG/2 DAY Clozapine C Date:11/29/04ISR Number: 4528054-2Report Type:Periodic Company Report #US_0409105472 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Consumer Zyprexa-Oral Initial or Prolonged Below Therapeutic Other (Olanzapine) Other Convulsion (Olanzapine) PS Phenytek (Phenytoin) C Zonegran (Zonisamide) C Escitalopram C Lorazepam C Diastat C Aricept (Donepezil Hydrochloride) C Clorazepate C Zocor (Simvastatin) C 24-Jun-2005 12:19 PM Page: 3243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4528058-XReport Type:Periodic Company Report #US_0409105517 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Consumer Zyprexa-Oral Required (Olanzapine) Intervention to (Olanzapine) PS Prevent Permanent Impairment/Damage Date:11/29/04ISR Number: 4528059-1Report Type:Periodic Company Report #US_0409105521 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Consumer Zyprexa-Oral Required (Olanzapine) Intervention to (Olanzapine) PS Prevent Permanent Impairment/Damage Date:11/29/04ISR Number: 4528060-8Report Type:Periodic Company Report #US_0408104879 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Fatigue Health (Olanzapine) Headache Professional (Olanzapine) PS 15 MG AT Impaired Healing BEDTIME Incontinence Zestril (Lisinopril) C Upper Respiratory Tract Celexa (Citalopram Infection Hydrobromide) C Vision Blurred 'Thimox' C Weight Decreased Celebrex (Celecoxib) C Weight Increased Singulair (Montelukast) C Nexium (Esomeprazole Magnesium) C 'Becusate' C Senokot (Senna Alexandrina) C Trazodone C Zyrtec (Cetirizine Hydrochloride) C Hydrochlorothiazide C Atrovent (Ipratropium Bromide) C Potassium C Vitamin C C Vitamin E (Herbal Oil Nos) C Date:11/29/04ISR Number: 4528063-3Report Type:Periodic Company Report #US_0408104748 Age: Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Pancreatitis Acute Health Initial or Prolonged Professional Company 24-Jun-2005 12:19 PM Page: 3244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/29/04ISR Number: 4528067-0Report Type:Periodic Company Report #USA040568116 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Zyprexa-Oral Initial or Prolonged Decreased Professional (Olanzapine) Other Company (Olanzapine) PS 10 MG/1 DAY Representative Date:11/29/04ISR Number: 4528069-4Report Type:Periodic Company Report #USA040567979 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ketoacidosis Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/1 DAY 8 MON Depakote (Valproate Semisodium) C Date:11/29/04ISR Number: 4528072-4Report Type:Periodic Company Report #USA030433103 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS Representative Date:11/29/04ISR Number: 4528085-2Report Type:Periodic Company Report #USA030228809 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Other Lipids Abnormal Company (Olanzapine) PS Representative Date:11/29/04ISR Number: 4528087-6Report Type:Periodic Company Report #USA021022803 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Diabetic Ketoacidosis Professional (Olanzapine) Pancreatitis (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4528091-8Report Type:Periodic Company Report #USA040566821 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 3 MON Representative Date:11/29/04ISR Number: 4528092-XReport Type:Periodic Company Report #USA040566771 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) Other Cerebrovascular Accident (Olanzapine) PS Hypertension Mevacor (Lovastatin) C Somnolence Weight Increased Date:11/29/04ISR Number: 4528094-3Report Type:Periodic Company Report #USA040466258 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gestational Diabetes Health Zyprexa-Oral Pre-Eclampsia Professional (Olanzapine) Weight Increased Company (Olanzapine) PS 10 MG/1 DAY Representative Nortriptyline C Lexapro (Escitalopram Oxalate) C Date:11/29/04ISR Number: 4528095-5Report Type:Periodic Company Report #USA040466263 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyphrenia Health Zyprexa-Oral Initial or Prolonged Cerebrovascular Accident Professional (Olanzapine) Other Decreased Activity (Olanzapine) PS 5 MG AT Depressed Level Of BEDTIME Consciousness Celexa (Citalopram Depression Hydrobromide) C Dyskinesia Ritalin Dysphemia (Methylphenidate Feeling Cold Hydrochloride) C Hypersomnia Remeron Weight Increased (Mirtazapine) C Mevacor (Lovastatin) C Lithium C Multivitamin C Aspirin C Vitamin E C 24-Jun-2005 12:19 PM Page: 3246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4528096-7Report Type:Periodic Company Report #USA040466247 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Professional (Olanzapine) Other Lethargy Company (Olanzapine) PS Representative Date:11/29/04ISR Number: 4530757-0Report Type:Periodic Company Report #USA040670227 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS Other Company Representative Date:11/29/04ISR Number: 4530759-4Report Type:Periodic Company Report #USA040670062 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Zyprexa-Oral Professional (Olanzapine) PS Company Representative Date:11/29/04ISR Number: 4530761-2Report Type:Periodic Company Report #USA040669737 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Nervousness (Olanzapine) PS 5 MG Trazadone (Trazodone) C Flonase (Fluticasone Propionate) C Date:11/29/04ISR Number: 4530762-4Report Type:Periodic Company Report #USA040669705 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Strattera Initial or Prolonged Syndrome Professional (Atomoxetine Other Pneumonia Aspiration Hydrochloride) PS Staphylococcal Infection Zyprexa-Oral (Olanzapine) SS Lexapro (Escitalopram) C Dilantin (Phenytoin Sodium) C Coumadin (Warfarin Sodium) C Tylenol (Paracetamol) C Metoprolo C Memantine Hydrochloride C 24-Jun-2005 12:19 PM Page: 3247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reminyl (Galantamine Hydrobromide) C Trileptal (Oxcarbazepine) C Bromocryptine Mesylate C Dantrolene C Levaquin (Levofloxacin) C Date:11/29/04ISR Number: 4530764-8Report Type:Periodic Company Report #USA040669682 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Evista (Raloxifene Initial or Prolonged Increased Appetite Professional Hydrochloride) PS 60 MG Company Zyprexa-Oral Representative (Olanzapine) SS Zoloft (Sertraline Hydrochloride) C Soma (Carisoprodol) C Topamax (Topiramate) C Norvasc (Amlodipine) C Prednsione C Zanaflex (Tizanidine Hydrochloride) C Pamelor (Nortriptyline Hydrochloride) C Date:11/29/04ISR Number: 4530766-1Report Type:Periodic Company Report #USA040669280 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa-Oral Hospitalization - Cerebral Infarction Professional (Olanzapine) PS 10 MG/1 AT Initial or Prolonged Confusional State Company BEDTIME Other Extrapyramidal Disorder Representative Plendil (Felodipine) C Muscle Rigidity Cozaar (Losartan Pneumonia Potassium) C Syncope Metoprolol C Vomiting Asa (Acetylsalicylic Acid) C Date:11/29/04ISR Number: 4530768-5Report Type:Periodic Company Report #USA040668956 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Zyprexa Initial or Prolonged Underweight Professional Zydis-Dispersible (Olanzapine) PS 10 MG DAY 24-Jun-2005 12:19 PM Page: 3248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4530770-3Report Type:Periodic Company Report #USA040668857 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa-Oral Initial or Prolonged Consciousness Professional (Olanzapine) PS 400 MG DAY Hypocalcaemia Company Ativan (Lorazepam) C Hypokalaemia Representative Lithium C Hyponatraemia Lexapro Overdose (Escitalopram Oxalate) C Mircette C Date:11/29/04ISR Number: 4530771-5Report Type:Periodic Company Report #USA040668894 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Zyprexa-Oral Initial or Prolonged Neuroleptic Malignant Professional (Olanzapine) PS 15 MG DAY 3 WK Other Syndrome Company Blood Pressure Representative Medications C Zoloft (Sertraline Hydrochloride) C Date:11/29/04ISR Number: 4530773-9Report Type:Periodic Company Report #USA040568756 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Zyprexa-Oral Initial or Prolonged Suicidal Ideation (Olanzapine) PS 15 MG DAY Concerta (Methylphenidate Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Date:11/29/04ISR Number: 4530775-2Report Type:Periodic Company Report #US_0403101321 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Health Zyprexa-Oral Disability Increased Professional (Olanzapine) Other Blood Glucose Increased (Olanzapine) PS 20 MG/2 DAY Blood Triglycerides Lexapro Increased (Escitalopram) C Lipitor (Atorvastatin) C Enalapril C Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Clonazepam C Avandamet C 24-Jun-2005 12:19 PM Page: 3249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4530778-8Report Type:Periodic Company Report #US_031299267 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/29/04ISR Number: 4530780-6Report Type:Periodic Company Report #US_010770104 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Humulin Human Nph Initial or Prolonged Hallucination Insulin (Rdna) Other Hospitalisation (Human Insulin) (Rd PS 80 U/DAY Lower Limb Fracture Zyprexa-Oral Nausea (Olanzapine) Palpitations (Olanzapine) SS Skin Ulcer Prozac-Oral Weight Decreased (Fluoxetine (Fluoxetine Hydrochloride) SS ORAL 20 MG Phentermine C Armour Thyroid (Thyroid) C Avandia (Rosiglitazone Maleate) C Magnesium C Redux (Dexfenfluramine Hydrochloride) C Novolin (Insulin Human Injection, Isophane) C Tryptophan, L- C Seroquel (Quetiapine Fumarate) C Weight Loss C Chromium C Vitamins C Glucophage (Metformin Hydrochloride) C Levothyroxine C Pondimin (Fenfluramine Hydrochloride) C Date:11/29/04ISR Number: 4530783-1Report Type:Periodic Company Report #US_010668260 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Diarrhoea (Olanzapine) Schizophrenia (Olanzapine) PS 20 MG/1 DAY Weight Increased Abilify (Aripiprazole) C Seroquel (Quetiapine Fumarate) C 24-Jun-2005 12:19 PM Page: 3250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) C Geodon (Ziprasidone Hydrochloride) C Thorazine (Chlorpromazine Hydrochloride) C Haldol (Haloperidol Decanoate) C Navane (Tiotixene) C Wellbutrin (Bupropion Hydrochloride) C Remeron (Mirtazapine Orifarm) C Zoloft (Sertraline Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Glucotrol (Glipizide) C Metaglip C Glucophage (Metformin) C Date:11/29/04ISR Number: 4530785-5Report Type:Periodic Company Report #USA040979569 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Consumer Zyprexa Initial or Prolonged Psychotic Disorder Zydis-Dispersible (Olanzapine) (Olanzapine) PS 25 MG DAY Seroquel (Quetiapine Fumarate) C Cogentin (Benzatropine Mesilate) C Date:11/29/04ISR Number: 4530788-0Report Type:Periodic Company Report #USA040979383 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Cymbalta (Duloxetine Other Drug Interaction Professional Hydrochloride) PS 60 MG DAY 2 WK Potentiation Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG DAY 2 DAY Date:11/29/04ISR Number: 4530790-9Report Type:Periodic Company Report #USA040979237 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 10 MG Representative 24-Jun-2005 12:19 PM Page: 3251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4530792-2Report Type:Periodic Company Report #USA040979069 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Dystonia Professional (Olanzapine) Hypotonia Company (Olanzapine) PS 10 MG Representative Date:11/29/04ISR Number: 4530794-6Report Type:Periodic Company Report #USA040979090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS Date:11/29/04ISR Number: 4530796-XReport Type:Periodic Company Report #USA040979143 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Cymbalta (Duloxetine Initial or Prolonged Excitability Professional Hydrochloride) PS 30 MG DAY Lipase Increased Zyprexa-Oral Pancreatitis Acute (Olanzapine) (Olanzapine) SS 5 MG DAY Neurontin (Gabapentin Pfizer) C Serax (Oxazepam) C Acetaminophen W/Hydrocodone C Date:11/29/04ISR Number: 4530801-0Report Type:Periodic Company Report #US_0407104110 Age:57 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Abdominal Hernia Other Abnormal Behaviour Accidental Overdose Aggression Anger Animal Bite Ankle Operation Arthralgia Arthropathy Asthenia Back Pain Bronchitis Bronchitis Acute Burning Sensation Bursitis Cellulitis Colonic Polyp Depression Diarrhoea Diarrhoea Haemorrhagic Drug Ineffective Epicondylitis 24-Jun-2005 12:19 PM Page: 3252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erectile Dysfunction Erythema Fall Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Prozac-Oral Feeling Drunk Health (Fluoxetine) Gun Shot Wound Professional (Fluoxetine Head Injury Company Hydrochloride) PS 40 MG DAY Headache Representative Zyprexa-Oral Hyperhidrosis (Olanzapine) SS 20 MG/1 AT Joint Swelling BEDTIME Knee Arthroplasty Clonazepam C Laceration Fluticasone Lethargy Propionate C Lip Pain Guaifenesin C Loss Of Consciousness Hydrochlorothiazide C Nausea Lansoprazole C Oedema Lisinopril C Osteoarthritis Morphine Sulfate C Pain Of Skin Naproxen (Naproxen Pneumonia Sodium) C Pruritus Sildenafirl Citrate C Rectal Haemorrhage Simvastatin Rotator Cuff Repair "Orifarm" Rotator Cuff Syndrome (Simvastatin Self-Injurious Ideation Ratiopharm) C Septoplasty Effexor (Venlafaxine Sinusitis Hydrochloride) C Somnolence Venlafaxine C Stress Rabeprazole C Suicidal Ideation Lovastatin C Suicide Attempt Lovastatin C Tachycardia Percocet C Tendonitis Tramadol C Tooth Disorder Motrin (Ibuprofen) C Treatment Noncompliance Omeprazole C Viral Upper Respiratory Albuterol C Tract Infection Vomiting Weight Increased Xanthogranuloma Date:11/29/04ISR Number: 4530804-6Report Type:Periodic Company Report #US_0406103739 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Anger (Olanzapine) PS 20 MG AT Anxiety BEDTIME Depression Ativan (Lorazepam) C Diabetes Mellitus Cogentin Diabetic Ketoacidosis (Benzatropine Insomnia Mesilate) C Irritability Paranoia Restlessness Somnolence Thinking Abnormal Weight Increased 24-Jun-2005 12:19 PM Page: 3253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4530805-8Report Type:Periodic Company Report #US_0406103675 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Zyprexa-Oral Initial or Prolonged Anger (Olanzapine) PS 40 MG AT Other Anxiety BEDTIME Apathy Abilitfy Depression (Aripiprazole) C Diabetes Mellitus Wellbutrin Sr Disturbance In Attention (Bupropion Diverticulitis Hydrochloride) C Dizziness Paxil (Paroxetine Fatigue Hydrochloride) C Flat Affect Antabuse Hypotension (Disulfiram) C Loss Of Consciousness Spironolactone C Muscle Spasms Lithium Carbonate C Muscle Twitching Nightmare Somnolence Weight Increased Date:11/29/04ISR Number: 4530808-3Report Type:Periodic Company Report #US_0405103231 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Zyprexa-Oral Hospitalization - Neuroleptic Malignant Health (Olanzapine) PS 15 MG/1 DAY Initial or Prolonged Syndrome Professional Inderal (Propranolol Hydrochloride) C Protonix (Pantoprazole) C Thiamine C Normal Saline C Ativan (Lorazepam) C Tylenol Extra Strength (Paracetamol) C Amitriptyline C Diazepam C Date:11/29/04ISR Number: 4530810-1Report Type:Periodic Company Report #US_0405103187 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Zyprexa-Oral Initial or Prolonged Hyperphagia (Olanzapine) PS 15 MG Hypertension Lithium C Polydipsia Haloperidol C Polyuria Valproate Bismuth C Tremor Prozac (Fluoxetine Vision Blurred Hydrochloride) C Weight Decreased Asa (Acetylsalicylic Acid C 24-Jun-2005 12:19 PM Page: 3254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4530814-9Report Type:Periodic Company Report #US_0405103066 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Zyprexa-Oral Initial or Prolonged Drug Withdrawal Syndrome Professional (Olanzapine) PS 20 MG/1 DAY Intentional Self-Injury Other Symbyax-Olanzapine Suicidal Ideation 12 Mg/Fluoxetine 25 Mg (Olanzapi SS 22 DAY Zyprexa-Oral (Olanzapine) SS Lithium Carbonate C Furosemide C Kcl (Potassium Chloride) C Mvi C Date:11/29/04ISR Number: 4530816-2Report Type:Periodic Company Report #US_0405103084 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa-Oral Initial or Prolonged Prescribed Overdose Professional (Olanzapine) Other (Olanzapine) PS 25 MG/1 AT BEDTIME Asa (Acetylsalicylic Acid) C Divalproex Sodium C Hidrochlorothiazide/ Triamterene C Temazepam C Trazodone C Date:11/29/04ISR Number: 4530818-6Report Type:Periodic Company Report #US_0405103085 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Increased (Olanzapine) Blood Triglycerides (Olanzapine) PS 25 MG DAY Decreased Lithium C Decreased Appetite Paxil (Paroxetine Depression Hydrochloride) C Diabetes Mellitus Neurontin Dysarthria (Gabapentin Pfizer) C Hepatic Enzyme Increased Klonopin Hepatic Function Abnormal (Clonazepam) C Hyperglycaemia Ativan (Lorazepam) C Hypertension Prilosec (Omeprazole Polydipsia Ratiopharm) C Polyuria Ambien (Zolpidem Prescribed Overdose Tartrate) C Vision Blurred 24-Jun-2005 12:19 PM Page: 3255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4530820-4Report Type:Periodic Company Report #US_0404102702 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa-Oral Initial or Prolonged Mental Status Changes Professional (Olanzapine) PS Other Neuroleptic Malignant Other Syndrome Date:11/29/04ISR Number: 4530822-8Report Type:Periodic Company Report #US_0403101703 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Orthostatic Hypotension Health Olanzapine-Oral Hospitalization - Overdose Professional (Olanzapine) PS 2.5 MG/1 DAY Initial or Prolonged Somnolence Company Remeron Suicide Attempt Representative (Mirtazapine) C Actos (Pioglitazone) C Apresoline (Hydralazine Hydrochloride) C Zocor (Simvastatin) C Date:11/30/04ISR Number: 4513471-7Report Type:Expedited (15-DaCompany Report #200414332FR Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Daonil PS Aventis Pharmaceuticals Inc. ORAL Tercian SS ORAL Zyprexa SS ORAL Befizal SS ORAL Date:11/30/04ISR Number: 4513499-7Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040607396 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Haldol PS INTRAMUSCULAR one ml of Abnormal solution Antipsychotic Drug Level contains 5mg Increased of haldol. Aspartate Heminevrin SS OROPHARINGEAL at night Aminotransferase Abnormal Stesolid SS INTRAMUSCULAR one ml of Blood Glucose Increased solution Cardiac Disorder contains 5mg Drug Interaction of diazepam Drug Toxicity Cisordinol SS INTRAMUSCULAR one ml of Gamma-Glutamyltransferase solution Abnormal contains 50mg Oedema of Pulmonary Oedema clopenthixol Somnolence Zyprexa SS Treatment Noncompliance Lithionit SS OROPHARINGEAL Disipal C 24-Jun-2005 12:19 PM Page: 3256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4513698-4Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0523799A Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Wellbutrin PS Glaxosmithkline ORAL 300MG Per day 11 MON Grand Mal Convulsion Symbyax SS Tongue Biting Fluoxetine C Date:11/30/04ISR Number: 4515254-0Report Type:Direct Company Report #CTU 233218 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Olanzapine PS INTRAMUSCULAR 10 MG IM X 1 Gait Disturbance Lorazepam SS INTRAMUSCULAR 2 MG IM X 1 Sedation Oxcarbazepine C Lithium C Risperidone C Date:11/30/04ISR Number: 4515256-4Report Type:Direct Company Report #USP 233220 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Olanzapine PS INTRAMUSCULAR 10 MG IM X 1 Hypotension Lorazepam SS INTRAMUSCULAR 2 MG IM X 1 Oral Intake Reduced Divalproex C Benztropine C Haloperidol C Ceftizoxime C Date:11/30/04ISR Number: 4516661-2Report Type:Expedited (15-DaCompany Report #JP_041105122 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa- Oral Other Intentional Misuse Company (Olanzapine) PS 50 MG DAY Representative Paxil (Paroxetine Distributor Hydrochloride) C Other Dogmatyl *Sulpiride) C Amoxan (Amoxapine) C Depromel (Fluvoxamine) C Silece (Flunitrazepam Eg) C Date:11/30/04ISR Number: 4516666-1Report Type:Expedited (15-DaCompany Report #US_0411108064 Age:37 YR Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Blood Triglycerides Increased Body Temperature Increased Cholestasis Haematocrit Decreased Haemoglobin Decreased Hepatic Steatosis Hepatitis Cholestatic 24-Jun-2005 12:19 PM Page: 3257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatotoxicity Herpes Simplex Leukopenia Report Source Product Role Manufacturer Route Dose Duration Nausea Foreign Olanzapine-Oral Neutropenia Literature (Olanzapine) PS 20 MG DAY Red Blood Cell Count Health Lithium C Decreased Professional Clonazepam C Serum Ferritin Decreased Other Biperiden C Splenomegaly Slow-Fe (Gerrous Upper Respiratory Tract Sulfate Exsiccated0 C Infection Date:11/30/04ISR Number: 4516667-3Report Type:Expedited (15-DaCompany Report #GBS041115957 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine- Oral Initial or Prolonged Increased Health (Olanzapine) PS 20 MG Other Grand Mal Convulsion Professional Procyclidine C 20 MG Hepatic Steatosis Other Procyclidine C Impaired Work Ability Joint Dislocation Date:11/30/04ISR Number: 4516668-5Report Type:Expedited (15-DaCompany Report #FR_041105193 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 20 MG /1 DAY Hyperthermia Professional Neuroleptic Malignant Other Syndrome Sedation Date:11/30/04ISR Number: 4516669-7Report Type:Expedited (15-DaCompany Report #EWC041141481 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Olanzapine- Oral Health (Olanzapine) PS 10 MG DAY Professional Other Date:11/30/04ISR Number: 4516670-3Report Type:Expedited (15-DaCompany Report #JP_041105032 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperlipidaemia Foreign Zyprexa -Oral Malaise Health (Olanzapine) PS 15 MG DAY Musculoskeletal Stiffness Professional Constan (Alprazolam Palpitations Company Dum) C Paraesthesia Representative Lexotan (Bromazepam) C Polycythaemia Other Rohypnol Somnolence (Flunitrazepam Eg) C Weight Increased Pursennid C 24-Jun-2005 12:19 PM Page: 3258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4517088-XReport Type:Expedited (15-DaCompany Report #FR_041005059 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Lactate Foreign Zyprexa-Oral Hospitalization - Dehydrogenase Increased Health (Olanzapine) Initial or Prolonged Convulsion Professional (Olanzapine) PS 10 MG/1 DAY Hypercreatininaemia Company Deroxat (Paroxetine Hypernatraemia Representative Hydrochloride) C Hyperthermia Other Urbanyl (Clobazam) C Laboratory Test Abnormal Leukocytosis Neuroleptic Malignant Syndrome Date:11/30/04ISR Number: 4517089-1Report Type:Expedited (15-DaCompany Report #FR_040904825 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa-Oral Hospitalization - Anorexia Health (Olanzapine)(Olanzap Initial or Prolonged Aphasia Professional ine) PS 17.5 MG/1 DAY Blood Glucose Increased Other Teralithe (Lithium Confusional State Carbonate) C Disturbance In Attention Depakote (Valproate Hypernatraemia Semisodium) C Incontinence Mutism Nephrogenic Diabetes Insipidus Overdose Pyrexia Tremor Date:11/30/04ISR Number: 4517095-7Report Type:Expedited (15-DaCompany Report #EWC041141408 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Olanzapine-Oral Initial or Prolonged Health (Olanzapine) PS Disability Professional Zyloric Company (Allopurinol) C Representative Coumadin (Warfarin Other Sodium) C Date:11/30/04ISR Number: 4517102-1Report Type:Expedited (15-DaCompany Report #EWC041040999 Age:57 YR Gender:Female I/FU:F Outcome PT Life-Threatening Blood Cholesterol Hospitalization - Increased Initial or Prolonged Gastroenteritis Gastrointestinal Disorder Hepatomegaly Hypertriglyceridaemia Multi-Organ Failure Pancreatic Cyst Pancreatitis Acute Pancreatitis Chronic 24-Jun-2005 12:19 PM Page: 3259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Failure Systemic Inflammatory Response Syndrome Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine)(Olanzap Professional ine) PS 10 MG DAY Other Diazepam C Date:11/30/04ISR Number: 4517103-3Report Type:Expedited (15-DaCompany Report #EWC041040948 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa-Oral Initial or Prolonged Aminotransferase Health (Olanzapine) Other Increased Professional (Olanzapine) PS 20 MG DAY Bipolar I Disorder Company Lorazepam C Blood Lactate Representative Clotiapine C Dehydrogenase Increased Other Bone Pain Femur Fracture Hyperhidrosis Joint Dislocation Leukocytosis Leukopenia Mucosal Dryness Neuroleptic Malignant Syndrome Pleurothotonus Post Procedural Complication Rhabdomyolysis Tremor Date:11/30/04ISR Number: 4517104-5Report Type:Expedited (15-DaCompany Report #CA_041007371 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Zyprexa-Oral Hospitalization - Aphagia Health (Olanzapine) Initial or Prolonged Extrapyramidal Disorder Professional (Olanzapine) PS 10 MG 6 WK Laryngeal Disorder Company Clonazepam C Pneumonia Aspiration Representative Propranolol C Other Date:11/30/04ISR Number: 4517112-4Report Type:Expedited (15-DaCompany Report #AU_041008138 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Olanzapine PS 30 MG DAY Hospitalization - Prescribed Overdose Health Aspirin Initial or Prolonged Respiratory Failure Professional (Acetylsalicylic Company Acid) C Representative Valproate Sodium C Other Simvastatin C Frusemide C Lithium C Thyroxine (Levothyroxine 24-Jun-2005 12:19 PM Page: 3260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Spironolactone (Spironolactone) C Date:11/30/04ISR Number: 4517590-0Report Type:Expedited (15-DaCompany Report #EWC041141418 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa-Rapid-Acting Hospitalization - Antipsychotic Drug Level Health Im (Olanzapine) PS 10 MG DAY Initial or Prolonged Increased Professional Zyprexa-Oral Anxiety Other (Olanzapine) Candida Sepsis (Olanzapine) SS 15 MG/1 DAY Condition Aggravated Quilonorm Retard Diabetes Insipidus (Lithium Carbonate) C Feeling Abnormal Lamictin Hallucination (Lamotrigine) C Mania Concor (Bisoprolol Renal Failure Fumarate) C Restlessness Eltroxin Status Epilepticus (Levothyroxine Sodium) C Date:11/30/04ISR Number: 4517634-6Report Type:Expedited (15-DaCompany Report #EWC041141415 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epilepsy Foreign Olanzapine-Dispersib Shock Health le (Olanzapine) PS 10 MG Professional Seroxat (Paroxetine Other Hydrochloride) C Temazepam C Date:11/30/04ISR Number: 4517643-7Report Type:Expedited (15-DaCompany Report #EWC041141420 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Foreign Zyprexa-Oral Initial or Prolonged Leukaemia Health (Olanzapine) Pancytopenia Professional (Olanzapine) PS 20 MG/1 DAY Pyrexia Other Stelazine (Trifluoperazine Hydrochloride) C Date:11/30/04ISR Number: 4517644-9Report Type:Expedited (15-DaCompany Report #AU_041108188 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanapine) Viral Infection Professional (Olanzapine) PS 30 MG/1 DAY Company Efexor (Venlafaxine) C Representative Solian (Amisulpride) C Other 24-Jun-2005 12:19 PM Page: 3261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4517726-1Report Type:Expedited (15-DaCompany Report #US_0411107788 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517727-3Report Type:Expedited (15-DaCompany Report #US_0411107791 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517728-5Report Type:Expedited (15-DaCompany Report #US_0411107792 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517730-3Report Type:Periodic Company Report #US_0411107698 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemangioma Consumer Zyprexa-Oral Other Pituitary Tumour Benign (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517754-6Report Type:Expedited (15-DaCompany Report #US_0411107785 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517755-8Report Type:Expedited (15-DaCompany Report #US_0411107713 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ketoacidosis Consumer Zyprexa-Oral Other Pancreatitis (Olanzapine) Renal Failure (Olanzapine) PS Date:11/30/04ISR Number: 4517756-XReport Type:Expedited (15-DaCompany Report #US_0411107760 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4517758-3Report Type:Expedited (15-DaCompany Report #US_0411107769 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517907-7Report Type:Expedited (15-DaCompany Report #AU_041108163 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im(Olanzapine) PS 10 MG OTHER Professional Lorazepam C Company Quetiapine C Representative Lithium Carbonate C Lorazepam C Zopiclone C Olanzapine C Date:11/30/04ISR Number: 4517911-9Report Type:Expedited (15-DaCompany Report #EWC040438731 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Zyprexa-Rapid-Acting Hospitalization - Bundle Branch Block Right Health Im (Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Drug Ineffective Professional Dehydrobenzperidol Electrocardiogram Qrs Company (Droperidol) C Complex Representative Trazolan (Trazodone Electrocardiogram Qt Hydrochloride) C Prolonged Diphantoine Mitral Valve Incompetence (Phenytoin Sodium) C Myocardial Infarction Torsade De Pointes Tricuspid Valve Incompetence Ventricular Dysfunction Ventricular Fibrillation Date:11/30/04ISR Number: 4517966-1Report Type:Expedited (15-DaCompany Report #US_0411108209 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Cholecystectomy (Olanzapine) Other Diabetes Mellitus (Olanzapine) PS 10 MG/1 DAY Weight Increased Date:11/30/04ISR Number: 4517971-5Report Type:Expedited (15-DaCompany Report #US_0411107766 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4517972-7Report Type:Expedited (15-DaCompany Report #US_0411107774 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517974-0Report Type:Expedited (15-DaCompany Report #US_0411107682 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517975-2Report Type:Expedited (15-DaCompany Report #US_0411107685 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517976-4Report Type:Expedited (15-DaCompany Report #US_0411107695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Ketoacidosis (Olanzapine) Pancreatitis (Olanzapine) PS Date:11/30/04ISR Number: 4517984-3Report Type:Expedited (15-DaCompany Report #US_0411107779 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517985-5Report Type:Expedited (15-DaCompany Report #US_0411107776 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517986-7Report Type:Expedited (15-DaCompany Report #US_0411107679 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4517987-9Report Type:Expedited (15-DaCompany Report #US_0411107784 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517988-0Report Type:Expedited (15-DaCompany Report #US_0411107781 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4517989-2Report Type:Expedited (15-DaCompany Report #US_0411107681 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4518005-9Report Type:Expedited (15-DaCompany Report #US_0410107180 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Consumer Zyprexa-Oral Basal Cell Carcinoma Health (Olanzapine) PS 15 MG/2 DAY Blood Cholesterol Professional Paxil (Paroxetine Abnormal Hydrochloride C Blood Triglycerides Celebrex (Celecoxib) C Increased Premarin C Chest Pain Zantac (Ranitidine Condition Aggravated Hydrochloride) C Depression Bextra (Caldecoxib) C Diabetes Mellitus Potassium C Diarrhoea Erythromycin Dysphagia (Erythromycin) C Dyspnoea Timolol C Ear Disorder Lotrisone C Fungal Infection Xenical (Orlistat) C Gastrooesophageal Reflux Lasix (Furosemide) C Disease Famvir (Penciclovir) C Glaucoma Herpes Simplex Hordeolum Hypertension Hypoglycaemia Irritability Obesity Oedema Painful Defaecation Rash Restlessness Tachycardia Weight Increased 24-Jun-2005 12:19 PM Page: 3265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4518007-2Report Type:Expedited (15-DaCompany Report #US_0404102096 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Consumer Zyprexa-Oral Hospitalization - Brain Damage Health (Olanzapine) Initial or Prolonged Drug Dependence Professional (Olanzapine) PS 20 MG/1 AT Disability Drug Intolerance BEDTIME Emotional Disorder Luvox 9fluvoxamine Extrapyramidal Disorder Maleate) C Glucose Tolerance Test Zoloft (Sertraline Abnormal Hydrochloride) C Neuroleptic Malignant Paxil (Paroxetine Syndrome Hydrochloride) C Panic Disorder Xanax (Alprazolam Tardive Dyskinesia Dum) C Buspar (Buspirone Hydrochloride) C Seroquel (Quetiapine Fumarate0 C Celexa (Citalopram Hydrobromide) C Ativan (Lorazepam) C Zantac (Ranitidine Hydrochloride) C Reglan (Metoclopramide Hydrochloride) C Prilosec (Omeprazole Rtiopharm) C Acetaminophen C Darvocet-N 100 C [Henergan (Promethazine Hydrochloride) C Ancef (Cefazolin Sodium) C Codeine C Date:11/30/04ISR Number: 4518015-1Report Type:Expedited (15-DaCompany Report #USA041082188 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Consumer Forteo Initial or Prolonged Pharmaceutical Product Health (Teriparatide) PS 20 UG DAY Complaint Professional Zyprexa-Oral Pyrexia (Olanzapine) SS Upper Respiratory Tract Remicade Infection (Infliximab) C White Blood Cell Count Plaquenil Increased (Hydrochloroquine Sulfate) C Methotrexate C Atenolol C Depakote (Valproate Semisodim) C Neurontin (Gabapentin Pfizer) C 24-Jun-2005 12:19 PM Page: 3266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4518106-5Report Type:Expedited (15-DaCompany Report #US_0411108251 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Weight Decreased (Olanzapine) (Olanzapine) PS Date:11/30/04ISR Number: 4518179-XReport Type:Expedited (15-DaCompany Report #USA040978500 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine / Professional Fluoxetine (Ola PS Company Representative Date:12/01/04ISR Number: 4515213-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0357672A Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Deroxat PS Glaxosmithkline ORAL 13 DAY Initial or Prolonged Disturbance In Attention Xanax SS ORAL WK Hypokalaemia Laroxyl SS Glaxosmithkline ORAL Hyponatraemia Zyprexa SS ORAL 37 DAY Impaired Self-Care Aricept SS ORAL Zestoretic SS ORAL Inipomp SS ORAL Date:12/01/04ISR Number: 4517739-XReport Type:Direct Company Report #CTU 233424 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Zyprexa 15 Mg PS ORAL PO Q AM 2 WK Sensation Of Heaviness Date:12/01/04ISR Number: 4518700-1Report Type:Expedited (15-DaCompany Report #GBWYE228924NOV04 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Efexor (Venlafaxine Initial or Prolonged Pregnancy Health Hydrochloride, , 0) PS Disability Feeding Problem In Professional Olanzapine Newborn Other (Olanzapine, , 0) SS Hypokinesia Lethargy Date:12/01/04ISR Number: 4518907-3Report Type:Expedited (15-DaCompany Report #2004UW23847 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Zyprexa SS 24-Jun-2005 12:19 PM Page: 3267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/04ISR Number: 4520190-XReport Type:Direct Company Report #CTU 233417 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Zyprexa PS ORAL 10 MG PO Initial or Prolonged QD/11/4/2004 @5AM Date:12/02/04ISR Number: 4516281-XReport Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041102757 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Tramal PS UNKNOWN Disturbance In Attention Tramal SS UNKNOWN Drug Interaction Mirtazapine C UNKNOWN Restlessness Diazepam C UNKNOWN Serotonin Syndrome Lansoprazole C UNKNOWN Prochlorperazine C UNKNOWN Olanzapine I UNKNOWN Date:12/02/04ISR Number: 4518407-0Report Type:Expedited (15-DaCompany Report #GBWYE117918OCT04 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Efexor Xl Initial or Prolonged Neuroleptic Malignant Professional (Venlafaxine Other Syndrome Hydrochloride Capsule, Extended Release) PS ORAL 75 MG 1X PER 1 DAY Olanzapine (Olanzapine ) SS ORAL 10 MG 1X PER 1 DAY Date:12/02/04ISR Number: 4519453-3Report Type:Expedited (15-DaCompany Report #A044-002-005325 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Aricept (Donepezil Initial or Prolonged Disturbance In Attention Health Hydrochloride) PS ORAL 1 IN 1 D, Professional ORAL Laroxyl(Amitriptylin e Hydrochloride) SS ORAL ORAL Xanax (Alprazolam) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Deroxat (Paroxetine Hydrochloride) SS ORAL ORAL Zestoretic (Prinizde) C Inipomp (Pantoprazole) C Date:12/02/04ISR Number: 4520197-2Report Type:Direct Company Report #CTU 233535 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyprexa 5mg PS Syncope 24-Jun-2005 12:19 PM Page: 3268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/04ISR Number: 4518295-2Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0275099-00 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Depakote Tablets PS ORAL Hospitalization - Anorexia Depakote Tablets SS Initial or Prolonged Aphasia Lithium Carbonate SS ORAL Blood Creatinine Olanzapine SS ORAL Increased Olanzapine SS Blood Glucose Increased Confusional State Disturbance In Attention General Physical Health Deterioration Hypernatraemia Mutism Nephrogenic Diabetes Insipidus Pyrexia Tremor Urinary Incontinence Date:12/03/04ISR Number: 4518969-3Report Type:Direct Company Report #CTU 233633 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Symbyax Eli Lilly PS Eli Lilly ORAL QAM ORAL Initial or Prolonged Swollen Tongue Required Intervention to Prevent Permanent Impairment/Damage Date:12/03/04ISR Number: 4520391-0Report Type:Expedited (15-DaCompany Report #2004243165JP Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clindamycin Phosphokinase Increased Health Phosphate Solution, Peritonsillar Abscess Professional Sterile (Clindamycin Company Phosphate) PS INTRAVENOUS INTRAVENOUS Representative Unasyn S (Unacide) (Sulbactam, Ampicillin) SS INTRAVENOUS INTRAVENOUS Fluvoxamine (Fluvoxamine) SS ORAL 150 MG, ORAL Olanzapine (Olanzapine) SS ORAL 20 MG, ORAL Loxoprofen Sodium (Loxoprofen Sodium) C Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C 24-Jun-2005 12:19 PM Page: 3269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/04ISR Number: 4521103-7Report Type:Expedited (15-DaCompany Report #GRWYE228524NOV04 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplopia Health Efexor Xr Drug Interaction Professional (Venlafaxine Hydrochloride, Capsule, Extended Release, 0) PS ORAL 150 MG 2X PER 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 10 MG 1X PER 1 DAY Date:12/06/04ISR Number: 4519097-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741450 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Aripiprazole PS Otsuka Hospitalization - Coma Pharmaceutical Initial or Prolonged Completed Suicide Company, Ltd. ORAL Drug Abuser Paroxetine SS ORAL Hyperchloraemia Olanzapine SS ORAL Hyperglycaemia Carbamazepine SS Hypernatraemia Hypokalaemia Rhabdomyolysis Supraventricular Tachycardia Date:12/06/04ISR Number: 4519127-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041200490 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Change Risperdal PS OROPHARINGEAL Initial or Prolonged Olanzapine SS OROPHARINGEAL 10- 15 mg Disability daily dose Other Zoplicone C OROPHARINGEAL Bendrofluazide C OROPHARINGEAL Date:12/06/04ISR Number: 4520881-0Report Type:Expedited (15-DaCompany Report #GBWYE117918OCT04 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Efexor Xl Initial or Prolonged Neuroleptic Malignant Professional (Venlafaxine Other Syndrome Hydrochloride, Capsule, Extended Release, 0) PS ORAL 75 MG 1X PER 1 DAY ORAL Olanzapine (Olanzapine) SS ORAL 10 MG 1X PWER 1 DAY ORAL 24-Jun-2005 12:19 PM Page: 3270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/04ISR Number: 4521228-6Report Type:Expedited (15-DaCompany Report #2004-BP-12204RO Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Methadone Hcl Electrocardiogram Qt Literature Tablets Usp, 10 Mg Corrected Interval (Methadone Prolonged Hydrochloride) PS ORAL 140 MG, PO Clarithromycin Tablets Usp, 500mg (Clarithromycin) SS 1 G Olanzapine (Olanzapine) SS 10 MG Ritonavir (Ritonavir) SS 200 MG Abacavir (Abacavir) C Ceftriaxone (Ceftriaxone) C Flurazepam (Flurazepam) C Lamivudine (Lamivudine) C Lopinavir (Lopinavir) C Lorazepam (Lorazepam) C Date:12/06/04ISR Number: 4531350-6Report Type:Periodic Company Report #USA040978353 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Cymbalta (Duloxetine Suicide Attempt Professional Hydrochloride) PS 5 DSG FORM Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 DSG FORM Depakote (Valproate Semisodium) C Aspirin (Acetylsalicylic Acid) C Date:12/06/04ISR Number: 4531744-9Report Type:Periodic Company Report #USA040979146 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa-Oral Somnolence (Olanzapine) Weight Increased (Olanzapine) PS 5 MG/1 IN THE EVENING Cymbalta (Duloxetine Hydrochloride) SS 60 MG/1 DAY Zoloft (Setraline Hydrochloride) C Cocaine C 24-Jun-2005 12:19 PM Page: 3271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/04ISR Number: 4532322-8Report Type:Periodic Company Report #USA040979215 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine Professional 6mg / Fluoxetine Company 25mg (Olanzapine PS Representative Cymbalta (Duloxetine Hydrochloride) SS 60 MG Hydrocodone C Date:12/06/04ISR Number: 4532337-XReport Type:Periodic Company Report #US_0411107671 Age:41 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Health Cymbalta (Duloxetine Professional Hydrochloride) PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS Haldol (Haloperidol Decanoate) C Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Date:12/06/04ISR Number: 4533038-4Report Type:Periodic Company Report #USA041081704 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Health Cymbalta (Duloxetine Professional Hydrochloride) PS 60 MG DAY Company Symbyax-Olanzapine / Representative Fluoxetine (Unknown Dose) (Ola SS Luvox (Fluvoxamine Maleate) C Date:12/06/04ISR Number: 4533348-0Report Type:Periodic Company Report #USA040876845 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Cymbalta (Duloxetine Bone Pain Hydrochloride) PS 60 MG/1 DAY 13 DAY Drug Ineffective Prozac-Oral Erectile Dysfunction (Fluoxetine) Feeling Abnormal (Fluoxetine Increased Appetite Hydrochloride) SS 30 MG/1 DAY 7 YR Influenza Like Illness Zyprexa-Oral Job Dissatisfaction (Olanzapine) Obsessive Thoughts (Olanzapine) SS 5 MG DAY 5 YR Pain Fluoxetine Sensory Disturbance (Fluoxetine) C Thinking Abnormal Depakote (Valproate Weight Increased Semisodium) C Klonopin (Clonazepam) C Ambien (Zolpidem 24-Jun-2005 12:19 PM Page: 3272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) C Navane (Tiotixene) C Wellbutrin (Bupropion Hydrochloride) C Prevacid (Lansoprazole) C Date:12/07/04ISR Number: 4521798-8Report Type:Expedited (15-DaCompany Report #USA040978509 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Rebound Health Zyprexa-Oral Tenderness Professional (Olanzapine) Blood Urine Present (Olanzapine) PS 10 MG DAY Strattera (Atomoxetine Hydrochloride) SS 60 MG DAY Trileptal (Oxcarbazepine) C Date:12/07/04ISR Number: 4521800-3Report Type:Expedited (15-DaCompany Report #US_0407104266 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Consumer Zyprexa-Dispersible Initial or Prolonged Confusional State Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 30 MG/D 2 YR Libido Decreased Cogentin Migraine (Benzatropine Psychotic Disorder Mesilate) C Somnolence Trileptal Tooth Impacted (Oxcarbazepine) C Weight Increased Effexor-Xr (Venlafaxine Hydrochloride) C Aricept (Donepezil Hydrochloride) C Seroquel (Quetiapine Fumarate) C Provigil (Modafinil) C Trilafon (Perphenazine Enantate) C Glucophage (Metformin) C Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Zonegran (Zonisamide) C Zantac (Ranitidine Hydrochloride) C Celexa (Citalopram Hydrobromide) C Abilify (Aripiprazole) C Risperdal 24-Jun-2005 12:19 PM Page: 3273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) C Vitamin E C Date:12/07/04ISR Number: 4522149-5Report Type:Expedited (15-DaCompany Report #USA041184443 Age:55 YR Gender:Male I/FU:U Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine)(Olanzap ine) PS 10 MG/M2 DAY Alupent (Orciprenaline Sulfate) C Imipramine C Neurontin (Gabapentin Pfizer) C Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Darvocet-N C Norvasc (Amlodipine) C Date:12/07/04ISR Number: 4522150-1Report Type:Expedited (15-DaCompany Report #USA041184199 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Zyprexa-Oral Increased Professional (Olanzapine) Heart Rate Irregular (Olanzapine) PS 5 MG/ 1 DAY Pericardial Effusion Lipitor (Atorvastatin Calcium) C Fiber C Tarka C Date:12/07/04ISR Number: 4522151-3Report Type:Expedited (15-DaCompany Report #USA041184234 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG Seroquel (Quetiapine Fumarate) C Cogentin (Benzatropine Mesilate) C Clonazepam C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 3274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522153-7Report Type:Expedited (15-DaCompany Report #USA041184110 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Sodium Decreased Consumer Zyprexa-Oral Hospitalization - Blood Test Abnormal (Olanzapine ) Initial or Prolonged Cardiac Arrest (Olanzapine) PS 20 MG DAY Other Grand Mal Convulsion Lithium C Nervous System Disorder Wellbutrin Thrombosis (Bupropion Unevaluable Event Hydrochloride) C Urine Analysis Abnormal Depakote (Valproate Semisdoium) C Ambien (Zolpidem Tartrate) C Flonase (Fluticasone Propionate) C Nexium (Esomeprazole Magnesium) C Date:12/07/04ISR Number: 4522194-XReport Type:Expedited (15-DaCompany Report #US_0411108592 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Olanzapine-Oral Initial or Prolonged Drug Toxicity Literature (Olanzapine) PS Loss Of Consciousness Health Miosis Professional Date:12/07/04ISR Number: 4522212-9Report Type:Expedited (15-DaCompany Report #EWC040438731 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zyprexa-Rapid-Acting Hospitalization - Akinesia Health Im(Olanzapine) PS 10 MG/1 DAY Initial or Prolonged Atrioventricular Block Professional Dehydrobenzperidol Complete Company (Droperidol) C Bundle Branch Block Right Representative Trazolan(Trazodone Drug Effect Decreased Other Hydrochloride) C Electrocardiogram Diphantoine Abnormal (Phenytoin Sodium) C Electrocardiogram Qt Prolonged Mitral Valve Incompetence Torsade De Pointes Tricuspid Valve Incompetence Ventricular Arrhythmia Ventricular Fibrillation Date:12/07/04ISR Number: 4522252-XReport Type:Expedited (15-DaCompany Report #USA041184091 Age:25 YR Gender:Male I/FU:I Outcome PT Death Alcohol Use Cough Hiccups Hypersomnia Increased Appetite 24-Jun-2005 12:19 PM Page: 3275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Treatment Noncompliance Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Symbyax-Olanzapine Professional 12mg / Fluoxetine 25mg (Olanzapi PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG/1 DAY Zoloft (Sertraline Hydrochloride) C Methadone C Date:12/07/04ISR Number: 4522256-7Report Type:Expedited (15-DaCompany Report #US_0411108648 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Other Symbyax-Olanzapine 6mg / Fluoxetine 25 Mg (Olanzapin PS Date:12/07/04ISR Number: 4522261-0Report Type:Expedited (15-DaCompany Report #US_0405103315 Age:39 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Adenoma Benign Other Anxiety Arthralgia Chest Pain Contusion Diabetes Mellitus Difficulty In Walking Dilatation Atrial Disturbance In Attention Drug Abuser Drug Screen Positive Dyspnoea Ear Pain Ejection Fraction Decreased Fatigue Gait Disturbance Gingival Pain Hallucination Headache Hypoaesthesia Irritability Local Swelling Major Depression Mitral Valve Incompetence Neck Pain Nervousness Oedema Peripheral Oral Intake Reduced Pain In Extremity Pain In Jaw Suicidal Ideation Tremor 24-Jun-2005 12:19 PM Page: 3276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tricuspid Valve Incompetence Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 12.5 MG/1 AT BEDTIME Zoloft (Sertraline Hydrochloride) C Glucophage Xr(Metformin Hydrochloride) C Zocor (Simvastatin Ratiopharm) C Lipitor (Atorvastatin Calcium0 C Verapamil C Aspirin (Acetylsalicylic Acid) C Multivitamin C Haldol (Haloperidol Decanoate) C Paxil (Paroxetine Hydrochloride) C Advicor C Colace (Docusate Sodium) C Cozaar (Losartan Potassium) C Allegra (Fexofenadine Hydrochlordie) C Lorcet Plus C Tylenol With Codeine C Darvocet-N 100 C Ultram (Tramadol Hydrochloride) C Risperdal (Risperidone) C Percocet C Vicodin C Nascort (Budesonide) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Tranxene (Clorazepate Dipotassium) C Surbex-T C Mylanta C Milk Of Magnesia C Aripiprazole C Verapamil C Clorazepate Dipotassium C Thiamine Hydrochloride C Benadryl C 24-Jun-2005 12:19 PM Page: 3277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522315-9Report Type:Expedited (15-DaCompany Report #US_0411108017 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Symbyax-Olanzapine 6 Convulsion Health Mg/ Fluoxetine 25 Mg Professional (Olanzapin PS Company Representative Date:12/07/04ISR Number: 4522484-0Report Type:Expedited (15-DaCompany Report #US_0411108386 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) PS Extrapyramidal Disorder Hyperglycaemia Hypertension Myocardial Infarction Weight Increased Date:12/07/04ISR Number: 4522487-6Report Type:Expedited (15-DaCompany Report #US_0411108616 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Prerenal Failure Literature Olanzapine Oral Initial or Prolonged Beta Haemolytic Health (Olanzapine) PS 10 MG DAY Other Streptococcal Infection Professional Benztropine C Blood Creatinine Valproic Acid C Increased Hydrochlorothiazide C Blood Sodium Increased Blood Urea Increased Chills Coma Electrocardiogram T Wave Peaked Headache Hyperglycaemic Hyperosmolar Nonketotic Syndrome Hyperhidrosis Miosis Oxygen Saturation Decreased Pancreatitis Protein Urine Present Pyrexia Sepsis Sinus Tachycardia Sputum Culture Positive Therapy Non-Responder Urine Ketone Body Present Vision Blurred White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 3278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522491-8Report Type:Expedited (15-DaCompany Report #US_0411108385 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:12/07/04ISR Number: 4522493-1Report Type:Expedited (15-DaCompany Report #USA041184281 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 2 YR Date:12/07/04ISR Number: 4522494-3Report Type:Expedited (15-DaCompany Report #US_0411108378 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Hypertension (Olanzapine) Myocardial Infarction (Olanzapine) PS Sleep Apnoea Syndrome Weight Increased Date:12/07/04ISR Number: 4522496-7Report Type:Expedited (15-DaCompany Report #USA041184426 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Imprisonment Health Zyprexa-Oral Murder Professional (Olanzapine) Suicidal Ideation Company (Olanzapine) PS 20 UG DAY Representative Date:12/07/04ISR Number: 4522510-9Report Type:Expedited (15-DaCompany Report #US_0411108586 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Olanzapine-Oral Initial or Prolonged Depressed Level Of Literature (Olanzapine) PS OTHER 50 MG OTHER Consciousness Health Benzodiazepine C Drug Toxicity Professional Hallucination Other Loss Of Consciousness Date:12/07/04ISR Number: 4522515-8Report Type:Expedited (15-DaCompany Report #GBS041115988 Age:52 YR Gender:Male I/FU:I Outcome PT Death Abnormal Behaviour Alcohol Poisoning Arthropathy Asthenia Atherosclerosis Bacterial Infection Bronchopneumonia 24-Jun-2005 12:19 PM Page: 3279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiomegaly Carditis Cerebral Atherosclerosis Report Source Product Role Manufacturer Route Dose Duration Coronary Artery Foreign Olanzapine-Oral Atherosclerosis Literature (Olanzapine) PS Drug Toxicity Health Aspirin Gastric Disorder Professional (Acetylsalicylic Hepatic Steatosis Other Acid) C Malaise Vitamin B C Pulmonary Oedema Simvastatin C Renal Disorder Scab Skin Ulcer Date:12/07/04ISR Number: 4522516-XReport Type:Expedited (15-DaCompany Report #AU_041108207 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Foreign Zyprexa-Oral Increased Health (Olanzapine) Completed Suicide Professional (Olanzapine) PS 10 MG DAY Overdose Other Therapeutic Agent Toxicity Date:12/07/04ISR Number: 4522518-3Report Type:Expedited (15-DaCompany Report #US_0411108578 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adjustment Disorder Foreign Olanzapine-Oral Initial or Prolonged Drug Toxicity Literature (Olanzapine) PS ORAL 300 MG OTHER Miosis Health Self-Medication Professional Other Date:12/07/04ISR Number: 4522529-8Report Type:Expedited (15-DaCompany Report #US_0411108576 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Olanzapine-Oral Initial or Prolonged Miosis Literature (Olanzapine) PS OTHER 160 MG OTHER Poisoning Health Psychomotor Agitation Professional Other Date:12/07/04ISR Number: 4522542-0Report Type:Expedited (15-DaCompany Report #EWC041141570 Age:12 WK Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Foreign Zyprexa Pregnancy Health Dysplasia Professional (Olanzapine) PS ORAL Other Legofer (Ferriprotinate) C Ferrum (Ferrous Fumarte) C Filicine 24-Jun-2005 12:19 PM Page: 3280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Folic Acid) C Trophicard C Calcium C Date:12/07/04ISR Number: 4522544-4Report Type:Expedited (15-DaCompany Report #FR_041105285 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa Initial or Prolonged Disturbance In Attention Health Professional (Olanzapine) PS ORAL Other Laroxyl (Amitripyline Hydrochloride0 SS Xanax (Alprazolam Dum) C Aricept (Donepezil Hydrochloride) C Deroxat (Paroxetine Hydrochloride) C Zestoretic C Inipomp (Pantoprazole) C Date:12/07/04ISR Number: 4522546-8Report Type:Expedited (15-DaCompany Report #JP_041105248 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abulia Foreign Zyprexa Autism Health Condition Aggravated Professional (Olanzapine) PS ORAL 20 MG DAY Dementia Company Risperdal Electroencephalogram Representative (Risperidone) C Abnormal Other Serenace (Haloperidol) C Cercine (Diazepam) C Artane (Trihexyphenidyl Hydrochloride) C Date:12/07/04ISR Number: 4522547-XReport Type:Expedited (15-DaCompany Report #EWC041141504 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zyprexa Initial or Prolonged Condition Aggravated Health (Olanzapine) PS 10 MG/2 DAY Electrocardiogram Qt Professional Serenase Prolonged Company (Haloperidol) C Syncope Representative Ventricular Extrasystoles Other 24-Jun-2005 12:19 PM Page: 3281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522548-1Report Type:Expedited (15-DaCompany Report #DE_041114747 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Zyprexa Initial or Prolonged Pregnancy Health Disability Large For Dates Baby Professional (Olanzapine) PS ORAL Congenital Anomaly Mental Disability Company Representative Other Date:12/07/04ISR Number: 4522549-3Report Type:Expedited (15-DaCompany Report #JP_040202669 Age:69 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Zyprexa-Oral Initial or Prolonged Asthenia Study (Olanzapine) Dysphagia Health (Olanzapine) PS 5 MG/1 DAY Hypoaesthesia Professional Risperdal Liver Disorder Other (Risperidone) C Parkinson'S Disease Tasmolin (Biperiden) C Productive Cough Mevalotin Schizophrenia, Paranoid (Pravastatin Sodium) C Type Lendormin Sluggishness (Brotizolam) C Upper Respiratory Tract Laxoberon (Sodium Inflammation Picosulfate) C Date:12/07/04ISR Number: 4522550-XReport Type:Expedited (15-DaCompany Report #FR_040904844 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Company Prozac-Oral Representative (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG/1 DAY Tercian (Cyamemazine) C Imovane (Zopiclone) C Lysanxia (Prazepam) C Methadone C Subutex (Buprenorphine Hydrochloride) C Forlax (Macrogol) C Date:12/07/04ISR Number: 4522551-1Report Type:Expedited (15-DaCompany Report #FR_040403838 Age:31 YR Gender:Female I/FU:F Outcome PT Death Asphyxia Other Cyanosis Diet Refusal Intracranial Haematoma Mendelson'S Syndrome Pulmonary Oedema 24-Jun-2005 12:19 PM Page: 3282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine)(Olanzap Professional ine) PS 20 MG/1 DAY Company Zyprexa-Rapid-Acting Representative Im (Olanzapine) SS 10 MG/1 OTHER Other Leponex (Clozapine) C Flupentixol C Date:12/07/04ISR Number: 4522557-2Report Type:Expedited (15-DaCompany Report #GBS041115871 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Olanzapine-Oral Hospitalization - Cardiomyopathy Health (Olanzapine) PS 10 MG Initial or Prolonged Hepatic Failure Professional Diazepam C Other Hepatic Necrosis Other Promazine C Multi-Organ Failure Dothiepin C Rhabdomyolysis Zopiclone (Zopiclone) C Date:12/07/04ISR Number: 4522558-4Report Type:Expedited (15-DaCompany Report #EWC040840381 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metrorrhagia Foreign Olanzapine-Oral Initial or Prolonged Pelvic Inflammatory Health (Olanzapine) PS 10 MG DAY Disease Professional Olanzapine C Other Date:12/07/04ISR Number: 4522559-6Report Type:Expedited (15-DaCompany Report #JP_041105061 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Zyprexa-Oral Myocardial Infarction Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Representative Other Date:12/07/04ISR Number: 4522560-2Report Type:Expedited (15-DaCompany Report #DE_040313182 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 10 MG DAY 2 MON Psychotic Disorder Company Zocor (Simvastatin) C Representative Doxepin C Other 24-Jun-2005 12:19 PM Page: 3283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522565-1Report Type:Expedited (15-DaCompany Report #US_0411108580 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Olanzapine-Oral(Olan Initial or Prolonged Consciousness Literature zapine) PS OTHER 60 MG; OTHER Drug Toxicity Health Perphenazine C Loss Of Consciousness Professional Multiple Drug Overdose Date:12/07/04ISR Number: 4522578-XReport Type:Expedited (15-DaCompany Report #FR_041105296 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypercholesterolaemia Foreign Zyprexa-Oral Other Liver Function Test Health (Olanzapine) Abnormal Professional (Olanzapine) PS 20 MG/1 DAY Weight Increased Company Lexomil (Bromazepam) C Representative Xanax (Alprazolam Other Dum) C Date:12/07/04ISR Number: 4522583-3Report Type:Expedited (15-DaCompany Report #GBS041116027 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Foreign Olanzapine-Oral Purpura Health (Olanzapine) PS 7.5 MG/1 DAY Vasculitis Professional Other Date:12/07/04ISR Number: 4522585-7Report Type:Expedited (15-DaCompany Report #GBS041115987 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Zyprexa-Oral Initial or Prolonged Pregnancy Health (Olanzapine)(Olanzap Disability Feeding Problem In Professional ine) PS Newborn Other Venlafaxine C Lethargy Motor Dysfunction Neonatal Disorder Date:12/07/04ISR Number: 4522587-0Report Type:Expedited (15-DaCompany Report #EWC041141491 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Anal Fissure Blood Potassium Decreased Electrolyte Imbalance Hallucination Leukocytosis Muscle Spasms Oedema Rebound Effect Red Blood Cell Sedimentation Rate Increased 24-Jun-2005 12:19 PM Page: 3284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Thrombocythaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 25 MG DAY Other Nexium (Esomeprazole Magnesium) C Cipramil (Citalopram Hydrobromide) C Nitrazepam C Multitabs C Imadrax (Amoxicillin Trihydrate) C Metronidazol (Metronidazole) C Truxal (Chlorprothixene Hydrochloride) C Citalopram C Iron C Furix (Furosemide) C Kaleorid (Potassium Chloride) C Date:12/07/04ISR Number: 4522589-4Report Type:Expedited (15-DaCompany Report #FR_041105230 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 15 MG/1 DAY Other Tercian (Cyamemazine) C Risperdal (Risperidone) C Date:12/07/04ISR Number: 4522591-2Report Type:Expedited (15-DaCompany Report #US_0411108594 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Olanzapine-Oral Initial or Prolonged Loss Of Consciousness Literature (Olanzapine) PS 200 MG OTHER Health Professional Other Date:12/07/04ISR Number: 4522622-XReport Type:Expedited (15-DaCompany Report #US_0411108584 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Olanzapine-Oral Initial or Prolonged Blood Ethanol Increased Literature (Olanzapine) PS OTHER 80 MG OTHER Drug Toxicity Health Hypotension Professional Loss Of Consciousness Other 24-Jun-2005 12:19 PM Page: 3285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522707-8Report Type:Expedited (15-DaCompany Report #FR_041105235 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Hypertriglyceridaemia Health (Olanzapine) Weight Increased Professional (Olanzapine) PS 10 MG DAY Other Date:12/07/04ISR Number: 4522708-XReport Type:Expedited (15-DaCompany Report #FR_040904845 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Xanax (Alprazolam Dum) C Date:12/07/04ISR Number: 4522711-XReport Type:Expedited (15-DaCompany Report #FR_041105245 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa-Oral Life-Threatening Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Other Tercian (Cyamemazine) C Daonil Faible (Glibenclamide) C Befizal (Bezafibrate) C Date:12/07/04ISR Number: 4522713-3Report Type:Expedited (15-DaCompany Report #FR_041105257 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombocytopenia Foreign Zyprexa-Oral Life-Threatening Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Other Depakote (Valproate Semisodium) C Lysanxia (Prazepam) C Date:12/07/04ISR Number: 4522715-7Report Type:Expedited (15-DaCompany Report #FR_041105271 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Creatinine Renal Foreign Zyprexa-Oral Initial or Prolonged Clearance Decreased Health (Olanzapine) Hepatocellular Damage Professional (Olanzapine) PS Other Nexen (Nimesulide) C Xyzall (Levocetirizine) C 24-Jun-2005 12:19 PM Page: 3286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522728-5Report Type:Expedited (15-DaCompany Report #2004100041 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Alprazolam Initial or Prolonged Disturbance In Attention Health (Alprazolam) PS ORAL ORAL Impaired Self-Care Professional Donepezil Hydrochloride (Donepezil Hydrochloride) SS ORAL ORAL Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL ORAL Paroxetine Hydrochloride (Paroxetine Hydrochloride) SS Olanzapine (Olanzapine) SS ORAL ORAL Prinzide (Hydrochloriothiazid e, Lisinopril) C Pantoprazole (Pantoprazole) C Date:12/09/04ISR Number: 4521722-8Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-02P-151-0206816-00 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Kaletra Soft Gelatin Initial or Prolonged Prolonged Capsules PS ORAL Other Pneumonia Primary Clarithromycin SS ORAL Atypical Methadone SS ORAL Olanzapine SS Ceftriaxone C INTRAVENOUS Lamivudine C ORAL Abacavir C ORAL Flurazepam C Lorazepam C Date:12/09/04ISR Number: 4521814-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Acute Risperdal PS OROPHARINGEAL Initial or Prolonged Drug Interaction Olanzapine SS OROPHARINGEAL 15-20 Neuroleptic Malignant mg/daily Syndrome Date:12/10/04ISR Number: 4523597-XReport Type:Direct Company Report #CTU 234093 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Gait Disturbance Zyprexa 10 Mg Hs PS ORAL PO 5 YR Movement Disorder 24-Jun-2005 12:19 PM Page: 3287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4524959-7Report Type:Expedited (15-DaCompany Report #2004AL000915 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Clonazepam Tablets Drug Toxicity Usp, 2 Mg (Purepac) PS Purepac ORAL PO Multiple Drug Overdose Tramadol SS ORAL PO Carisoprodol SS ORAL PO Olanzapine SS ORAL PO Ethanol SS ORAL PO Date:12/13/04ISR Number: 4526057-5Report Type:Direct Company Report #CTU 234166 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphagia Amiodarone 200 Mg Intervention to Swollen Tongue Udl PS Udl ORAL 800 MG DAILY Prevent Permanent Tongue Discolouration ORAL Impairment/Damage Zyprexa 2.5 Mg Lilly SS Lilly ORAL 2.5 MG DAILY ORAL Metoprolol C Xopenex C Zoloft C Ativan C Synthroid C Advair C Aspirin C Ambien C Date:12/13/04ISR Number: 4526623-7Report Type:Expedited (15-DaCompany Report #US_0411107951 Age:38 YR Gender:Female I/FU:I Outcome PT Other Alanine Aminotransferase Increased Binge Eating Blood Cholesterol Increased Blood Glucose Increased Blood Triglycerides Increased Coma Conjunctivitis Diabetes Mellitus Non-Insulin-Dependent Electrocardiogram Qt Prolonged Gastroenteritis Viral Gastrooesophageal Reflux Disease Injury Intervertebral Disc Disorder Joint Sprain Laceration Lethargy Menorrhagia Pruritus Rhinitis Allergic 24-Jun-2005 12:19 PM Page: 3288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinusitis Uterine Polyp Viral Upper Respiratory Report Source Product Role Manufacturer Route Dose Duration Tract Infection Consumer Zyprexa-Oral Vision Blurred Health (Olanzapine) PS 15 MG/1 DAY Weight Increased Professional Prozac (Fluoxetine Hydrochloride) C Zoloft (Sertrailine Hydrochloride) C Multivitamin C Minerals Nos C Paxil (Paroxetine Hydrochloride) C Klonopin (Clonazepam) C Nicotine Dermal Patch (Nicotine Resin) C Effexor (Venlafaxine Hydrochloride) C Serzone (Nefazodone Hydrochloride) C Restoril (Temazepam) C Geodon (Ziprasidone Hydrochloride) C Nicotinell Gum (Nicotine) C Nicotrol (Nicotine) C Ferrous Sulfate C Effexor-Xr (Venlafaxine Hydrochloride) C Risperdal (Risperidone) C Date:12/13/04ISR Number: 4526631-6Report Type:Expedited (15-DaCompany Report #US_991232959 Age:47 YR Gender:Male I/FU:F Outcome PT Life-Threatening Aortic Thrombosis Hospitalization - Bipolar Disorder Initial or Prolonged Blood Creatine Disability Phosphokinase Increased Other Cellulitis Coma Dehydration Diabetic Coma Diabetic Hyperosmolar Coma Diabetic Ketoacidosis Erythema Gangrene Glycosuria Hypercoagulation Hyperglycaemia Hypertension Hypoglycaemia Impaired Healing Insulin Resistance Ischaemia 24-Jun-2005 12:19 PM Page: 3289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kidney Malformation Leg Amputation Leukocytosis Report Source Product Role Manufacturer Route Dose Duration Metabolic Acidosis Consumer Zyprexa-Oral Necrosis Health (Olanzapine) Nephrogenic Diabetes Professional (Olanzapine) PS 15 MG/1 DAY Insipidus Lithium C Neuroleptic Malignant Valproic Acid C Syndrome Vasotec (Enalapril Neuropathic Pain Maleate) C Osteomyelitis Chronic Niaspan (Nicotinic Peripheral Embolism Acid) C Peripheral Vascular Indocin Disorder (Indometacin) C Polydipsia Prozac (Fluoxetine Polyuria Hydrochloride) C Tachycardia Prolixin Tachypnoea (Fluphenazine Therapeutic Agent Hydrochloride) C Toxicity Claritin Ulcer (Loratadine) C Vision Blurred Klonopin Vomiting (Clonazepam) C Weight Decreased Risperidone C Weight Increased Haldol (Haloperidol Wound Infection Deconate) C Stelazine (Trifluoperazine Hydrochloride) C Depakote (Valproate Semisodium) C Celexa (Citalopram Hydrobromide) C Paxil (Paroxetine Hydrochloride) C Insulin C Actos (Pioglitazone Hydrochloride) C Inderal (Propranolol Hydrochloride) C Trimacinolone C Prilosec (Omeprazole Ratiopharm) C Ativan (Lorazepam) C Docusate C Ferrous Sulfate C Neurontin (Gabapentin Pfizer) C Vitamin C C Nph Insulin (Insulin Injection, Isophane) C Abilify (Aripiprazole) C Flomax (Morniflumate) C Prevacid (Lansoprazole) C Ddavp (Desmopressin Acetate) C Glucotrol (Glipizide) C 24-Jun-2005 12:19 PM Page: 3290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardura (Doxazosin) C Artane (Trihexyphenidyl Hydrochloride) C Date:12/13/04ISR Number: 4526819-4Report Type:Expedited (15-DaCompany Report #US_0412108813 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Consumer Zyprexa-Oral Hypertension (Olanzapine) Myocardial Infarction (Olanzapine) PS Pancreatitis Date:12/13/04ISR Number: 4526820-0Report Type:Expedited (15-DaCompany Report #2004081893 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS 160 MG (80 Life-Threatening Agitation Professional MG, 2 IN 1 Hospitalization - Condition Aggravated Company D), Initial or Prolonged Neuroleptic Malignant Representative Geodon (Im) Syndrome (Ziprasidone) Self Injurious Behaviour (Ziprasidone) SS INTRAMUSCULAR INTRAMUSCULAR Ventricular Tachycardia Olanzapine (Olanzapine) SS All Other Therapeutic Products (All Other Therapeutic Products) C Date:12/14/04ISR Number: 4526372-5Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0359117A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Paracetamol PS Glaxosmithkline 1 DAY Initial or Prolonged Suicide Attempt Efexor SS Olanzapine SS 1 DAY Alcohol C Date:12/14/04ISR Number: 4526634-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0522931A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Wellbutrin PS Glaxosmithkline ORAL 150MG Twice Fall per day DAY Grand Mal Convulsion Ludiomil SS 150MG per day 3 MON Joint Dislocation Symbyax SS 2 MON Loss Of Consciousness Medication Error Upper Limb Fracture 24-Jun-2005 12:19 PM Page: 3291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/04ISR Number: 4528876-8Report Type:Expedited (15-DaCompany Report #2004-122313-NL Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Mirtazapine PS ORAL DF Initial or Prolonged Syndrome Professional Olanzapine SS ORAL 10 MG 59 DAY Sulpiride SS ORAL 400 MG 1 WK Citalopram C Date:12/14/04ISR Number: 4528920-8Report Type:Expedited (15-DaCompany Report #US_0412108806 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Pancreatic Carcinoma (Olanzapine) Pancreatitis (Olanzapine) PS Date:12/14/04ISR Number: 4529887-9Report Type:Expedited (15-DaCompany Report #US_0412108787 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:12/14/04ISR Number: 4534667-4Report Type:Periodic Company Report #USA040874166 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Cialis (Tadalafil) PS 20 MG Erectile Dysfunction Zyprexa-Oral Food Craving (Olanzapine) Haemorrhoidal Haemorrhage (Olanzapine) SS Mood Swings Strattera Sleep Disorder (Atomoxetine Stress Hydrochloride) SS Therapeutic Response Lexapro Decreased (Escitalopram Weight Decreased Oxalate) C Strattera (Atomoxetine Hydrochloride) C Viagra (Sildenafil Citrare) C Levitra (Vardenafil Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:12/15/04ISR Number: 4527821-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041202809 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Risperdal PS OROPHARINGEAL Other Neutropenia Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Olanzapine SS 8 DAY Chlorpromazine C 24-Jun-2005 12:19 PM Page: 3292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/04ISR Number: 4529924-1Report Type:Direct Company Report #CTU 234363 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Gait Disturbance Zyprexa 10 Mg Hs PS ORAL PO 5 YR Hypokinesia Date:12/16/04ISR Number: 4530485-1Report Type:Direct Company Report #CTU 234468 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Ziaprexa 5 Mg PS ORAL 5MG DAILY ORAL Date:12/16/04ISR Number: 4530769-7Report Type:Expedited (15-DaCompany Report #GBS040915669 Age:21 WK Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Olanzapine-Oral Drug Exposure During Health (Olanzapine) PS Pregnancy Professional Folic Acid C Dyskinesia Nicorette Patch (Nicotine) C Nicorette Patch (Nicotine) C Co-Proxamol C Codeine Phosphate C Date:12/16/04ISR Number: 4530772-7Report Type:Expedited (15-DaCompany Report #JP_040904404 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa-Oral Initial or Prolonged Mania Health (Olanzapine) Purpura Professional (Olanzapine) PS 5 MG DAY Company Depakene-R Representative (Valproate Sodium) C Rohypnol (Flunitrazepam Eg) C Amoban (Zopiclone) C Lithium C Date:12/16/04ISR Number: 4530774-0Report Type:Expedited (15-DaCompany Report #GBS040514966 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine-Oral Epilepsy Health (Olanzapine) PS 10 MG Hepatic Congestion Professional Lithium Carbonate C Mania Other Ibuprofen C Pulmonary Congestion Pulmonary Haemorrhage Pulmonary Oedema Salivary Hypersecretion Spleen Disorder Vomiting 24-Jun-2005 12:19 PM Page: 3293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/04ISR Number: 4530776-4Report Type:Expedited (15-DaCompany Report #JP_041105032 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Zyprexa-Oral Hyperlipidaemia Health (Olanzapine) Malaise Professional (Olanzapine) PS 15 MG DAY Musculoskeletal Stiffness Company Constan (Alprazolam Palpitations Representative Dum) C Paraesthesia Other Lexotan (Bromazepam) C Polycythaemia Rohypnol Somnolence (Flunitrazepam Eg) C Weight Increased Pursennid C White Blood Cell Count Increased Date:12/16/04ISR Number: 4530797-1Report Type:Expedited (15-DaCompany Report #EWC041241636 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Foreign Zyprexa-Dispersible Skin Exfoliation Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Company Lorazepam C Representative Hydroxyzine Other Hydrochloride C Flurazepam C Folic Acid C Vitamin B12 C Date:12/16/04ISR Number: 4530798-3Report Type:Expedited (15-DaCompany Report #EWC041241633 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Olanzapine-Oral Hospitalization - Gastrointestinal Necrosis Health (Olanzapine) PS 30 MG/1 DAY Initial or Prolonged Intestinal Ischaemia Professional Nozinan /Net/ Megacolon Company (Levomepromazine) C Respiratory Arrest Representative Biperiden C Other Date:12/16/04ISR Number: 4530799-5Report Type:Expedited (15-DaCompany Report #DE_041114783 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Zyprexa-Oral Hospitalization - Drug Ineffective Health (Olanzapine) Initial or Prolonged Neuroleptic Malignant Professional (Olanzapine) PS 35 MG DAY Syndrome Other Diazepam C Prescribed Overdose Polamidon (Methadone Pulmonary Congestion Hydrochloride) C Pyrexia Respiratory Failure Rhabdomyolysis Shock 24-Jun-2005 12:19 PM Page: 3294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/04ISR Number: 4530800-9Report Type:Expedited (15-DaCompany Report #GBS041216068 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dry Mouth Foreign Olanzapine-Oral Incontinence Health (Olanzapine) PS 5 MG Muscle Spasms Professional Tegretol Musculoskeletal Stiffness Other (Carbamazepine Somnolence Rivopharm) C Carbimazole C Date:12/16/04ISR Number: 4530802-2Report Type:Expedited (15-DaCompany Report #EWC041241679 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Other Delorazepam C Date:12/16/04ISR Number: 4530807-1Report Type:Expedited (15-DaCompany Report #FR_040904866 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Foreign Zyprexa-Oral Hypertrophy Breast Health (Olanzapine) Menorrhagia Professional (Olanzapine) PS 5 MG/1 DAY Company Representative Other Date:12/16/04ISR Number: 4530811-3Report Type:Expedited (15-DaCompany Report #EWC041241669 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Refusal Of Treatment By Foreign Zyprexa-Oral Hospitalization - Relative Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 10 MG Other Epilim (Valproate Sodium) C Clopixol Acuphase (Zuclopenthixol Acetate) C Diazepam C Date:12/16/04ISR Number: 4531129-5Report Type:Expedited (15-DaCompany Report #GBS041116039 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Artery Occlusion Foreign Olanzapine-Oral Initial or Prolonged Cerebrovascular Accident Health (Olanzapine) PS Disability Professional Metformin C Other Aspirin (Acetylsalicylic Acid) C 24-Jun-2005 12:19 PM Page: 3295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/04ISR Number: 4531132-5Report Type:Expedited (15-DaCompany Report #JP_041004822 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Electrocardiogram Qt Professional (Olanzapine) PS 10 MG/1 DAY Prolonged Company Vegetamin A C Excitability Representative Rohypnol Hallucination, Auditory Other (Flunitrazepam Eg) C Pursennid C Risperdal (Risperidone) C Akineton (Biperiden Lactate) C Date:12/16/04ISR Number: 4531401-9Report Type:Expedited (15-DaCompany Report #USA040979143 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lower Health Cymbalta (Duloxetine Initial or Prolonged Alcohol Use Professional Hydrochloride) PS 30 MG DAY Feeling Abnormal Zyprexa-Oral Pancreatitis Acute (Olanzapine) (Olanzapine) SS 5 MG DAY Neurontin (Gabapentin Pfizer) C Pfizer Serax (Oxazepam) C Acetaminophen W/Hydrochloride C Date:12/16/04ISR Number: 4531451-2Report Type:Expedited (15-DaCompany Report #US_0412108744 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:12/16/04ISR Number: 4531483-4Report Type:Expedited (15-DaCompany Report #USA040156731 Age:48 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Agitation Other Anger Anxiety Arthritis Back Pain Blindness Transient Chest Pain Crying Dizziness Postural Drug Ineffective Enterocele Faecal Incontinence Fall Fatigue Gastrointestinal Disorder 24-Jun-2005 12:19 PM Page: 3296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Cyst Hot Flush Hypoacusis Report Source Product Role Manufacturer Route Dose Duration Hypotension Consumer Prozac-Oral Impaired Healing Health (Fluoxetine) Insomnia Professional (Fluoxetine Intentional Self-Injury Company Hydrochloride) PS 40 MG Libido Decreased Representative Zyprexa-Oral Lymphadenopathy (Olanzapine) Memory Impairment (Olanzapine) SS 5 MG/1 AT Mood Swings BEDTIME Nerve Injury Prozac Weekly Onychomycosis (Fluoxetine Osteopenia Hydrochloride) C Overweight Fluoxetine C Palpitations Klonopin Panic Attack (Clonazepam) C Pharmaceutical Product Lexapro Complaint (Escitalopram) C Rib Fracture Serzone (Nefazodone Sexual Dysfunction Hydrochloride) C Suicidal Ideation Xanax (Alprazolam) C Suicide Attempt Topamax (Topiramate) C Tension Headache Vitamins C Toothache Trazadone Weight Fluctuation (Trazodone) C Ambien (Zolpidem Tartrate) C Alprazolam C Buspar (Buspirone Hydrochloride) C Risperdal (Risperidone) C Clonidine C Lamictal (Lamotrigine) C Premarin C Estratest C Orlistat C Phentermine C Famvir (Penciclovir) C Zovirax C Effexor-Xr (Venlafaxine Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Date:12/16/04ISR Number: 4531565-7Report Type:Expedited (15-DaCompany Report #US_0412108804 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Zyprexa-Oral Increased (Olanzapine) Diabetes Mellitus (Olanzapine) PS Hypertension Myocardial Infarction Weight Increased 24-Jun-2005 12:19 PM Page: 3297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/04ISR Number: 4531904-7Report Type:Expedited (15-DaCompany Report #USA041184719 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Zyprexa-Oral Initial or Prolonged Anxiety (Olanzapine) Fear (Olanzapine) PS 10 MG/1 DAY Hallucination Tylenol C Mental Disorder Panic Disorder Pneumonia Stress Urinary Incontinence Date:12/16/04ISR Number: 4531905-9Report Type:Expedited (15-DaCompany Report #USA041184844 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Abnormal Consumer Zyprexa-Oral Breast Cancer Female (Olanzapine) (Olanzapine) PS 5 MG/1 DAY Zocor (Simvastatin) C Aricept (Donepezil Hydrochloride) C Date:12/16/04ISR Number: 4531908-4Report Type:Expedited (15-DaCompany Report #USA041284892 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Consumer Zyprexa-Oral Initial or Prolonged Dehydration (Olanzapine) Other Drug Withdrawal Syndrome (Olanzapine) PS 5 MG DAY Treatment Noncompliance Date:12/16/04ISR Number: 4531911-4Report Type:Expedited (15-DaCompany Report #US_0412108858 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Zyprexa-Oral Increased (Olanzapine) Diabetes Mellitus (Olanzapine) PS Hypertension Myocardial Infarction Weight Increased Date:12/16/04ISR Number: 4531961-8Report Type:Expedited (15-DaCompany Report #OXYA20040003 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Acetaminophen/Oxycod Narcotic Intoxication Health one Unknown Professional Unknown PS ORAL PO Methadone SS ORAL PO Olanzapine SS ORAL PO Clonazepam C 24-Jun-2005 12:19 PM Page: 3298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/04ISR Number: 4530001-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Acute Risperdal PS OROPHARINGEAL Initial or Prolonged Drug Interaction Olanzapine SS OROPHARINGEAL 15-20 Neuroleptic Malignant mg/daily Syndrome Date:12/17/04ISR Number: 4530002-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040804627 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal Consta PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Risperidone SS Risperidone SS Olanzapine SS OROPHARINGEAL Lithium C OROPHARINGEAL 900 mg AM 600 mg PM Fluoxetine C OROPHARINGEAL Levothyroid C OROPHARINGEAL Pepcid C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Oxazepam C as needed Date:12/17/04ISR Number: 4530724-7Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0359987A Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Paroxetine PS Glaxosmithkline ORAL 40MG Per day Cardiovascular Disorder Olanzapine SS ORAL 2.5MG Per day Cerebrovascular Accident Circulatory Collapse Deep Vein Thrombosis Influenza Like Illness Myocardial Infarction Pulmonary Embolism Pulmonary Hypertension Date:12/20/04ISR Number: 4532260-0Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0272719-00 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Blood Bilirubin Increased Initial or Prolonged Cholelithiasis Condition Aggravated Hepatic Enzyme Increased Hepatotoxicity Hypomania Jaundice Cholestatic Nausea 24-Jun-2005 12:19 PM Page: 3299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Psychotic Disorder Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Vomiting Epival Tablets PS ORAL Epival Tablets SS ORAL Epival Tablets SS Ritonavir Soft Gelatin Capsules SS ORAL 786 DAY Ritonavir Soft Gelatin Capsules SS ORAL 786 DAY Tipranavir SS ORAL 787 DAY Procyclidine SS ORAL 151 DAY Olanzapine SS ORAL 3 YR Olanzapine SS ORAL 3 YR Risperidone SS ORAL 46 DAY Trazodone SS ORAL Trazodone SS ORAL Quetiapine SS ORAL 23 DAY Clonazepam SS ORAL Carbamazepine SS 9 DAY Paracetamol SS ORAL 642 DAY Paracetamol SS 642 DAY Lamivudine C ORAL 128 DAY Lamivudine C 128 DAY Abacavir C ORAL 128 DAY Abacavir C 128 DAY Atovaquone C ORAL 154 DAY Atovaquone C 154 DAY Calcium Carbonate C ORAL 4 YR Magic Mouthwash C 204 DAY Nystatin C ORAL 12 YR Megavim C ORAL Enfuvirtide (T-20) C SUBCUTANEOUS Enfuvirtide (T-20) C Bisacodyl C Bisacodyl C Choral Hydrate C Lactulose C 209 DAY Imodium C 4 YR Diphenhydramine Hydrochloride C INTRAVENOUS Diphenhydramine Hydrochloride C ORAL Diphenhydramine Hydrochloride C INTRAMUSCULAR Kaletra C 3 DAY Lithium C 4 DAY Date:12/20/04ISR Number: 4548034-0Report Type:Periodic Company Report #USA040567263 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Blindness Other Blood Glucose Increased Blood Pressure Decreased Convulsion Diabetes Mellitus Dyspepsia Hypoaesthesia 24-Jun-2005 12:19 PM Page: 3300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Nausea Pain Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Consumer Prozac-Oral Vision Blurred (Fluoxetine) Weight Increased (Fluoxetine Hydrochloride) PS 80 MG/DAY 6 YR Humulin-Human Insulin (Rdna):30% Regular, 70% Nph (H SS 78 U DAY Humalog.- (Lispro) SS Zyperxa-Oral (Olanzapine) SS Dilantin (Phenytoin Sodium) C Tegretol (Carbamazepine) C Risperidone C Ativan (Lorazepam) C Vioxx (Rofecoxib) C Centrum A To Zinc C Date:12/20/04ISR Number: 4548326-5Report Type:Periodic Company Report #US_0409105266 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa Initial or Prolonged Apathy Health Zydis-Dispersible Asthenia Professional (Olanzapine) PS 15 MG Blood Cholesterol Zyprexa-Oral Increased (Olanzapine) Blood Glucose Increased (Olanzapine) SS ORAL 2.5 MG/1 AT Diabetes Mellitus BEDTIME Non-Insulin-Dependent Prozac Disturbance In Attention (Fluoxetine Dizziness Hydrochloride) SS ORAL Drug Ineffective Humulin-Human Dysphoria Insulin (Rdna): 30% Dyspnoea Regular, 70% Nph (H SS 30 U/IN THE Fear MORNING Gastroenteritis Viral Effexor (Venlafaxine Increased Appetite Hydrochloride) C Initial Insomnia Klonopin Insomnia (Clonazepam) C Lethargy Tegretol Overdose (Carbamazepine Panic Reaction Rivopharm) C Somnolence Wellbutrin Sr Suicidal Ideation (Bupropion Tearfulness Hydrochloride) C Tremor Ambien (Zolpidem Vision Blurred Tartrate) C Weight Increased Lexapro (Escitalopram Oxalate) C Gabitril (Tiagabine Hydrochloride) C Synthroid (Levothyroxine Sodium) C 24-Jun-2005 12:19 PM Page: 3301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel (Quetiapine Fumarate) C Remeron (Mirtazapine Orifarm) C Date:12/20/04ISR Number: 4548327-7Report Type:Periodic Company Report #US_0409105193 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Abnormal Consumer Humulin-Human Initial or Prolonged Blood Glucose Increased Insulin : 30% Other Diabetes Mellitus Regular, 70% Nph (H PS 50 U DAY Hypertension Zyprexa-Oral Retinitis (Olanzapine) Visual Disturbance (Olanzapine) SS Weight Increased Depakote (Valproate Semisodium) C Lithium C Metformin C Lisinopril (Lisinopril) C Lescol (Fluvastatin) C Date:12/20/04ISR Number: 4548329-0Report Type:Periodic Company Report #US_0408104540 Age:42 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aspiration Initial or Prolonged Balance Disorder Other Dehydration Diabetes Mellitus Non-Insulin-Dependent Diabetic Coma Diabetic Ketoacidosis Disseminated Intravascular Coagulation Electroencephalogram Abnormal Encephalopathy Hyperglycaemia Hypertension Hypoglycaemia Impaired Gastric Emptying Increased Appetite Low Density Lipoprotein Increased Mass Menopausal Symptoms Metabolic Acidosis Oedema Otitis Media Pancreatic Cyst Pancreatitis Perineal Pain Pollakiuria Pyrexia Renal Failure Acute Respiratory Failure Rhabdomyolysis 24-Jun-2005 12:19 PM Page: 3302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Shock Sinobronchitis Sinus Congestion Report Source Product Role Manufacturer Route Dose Duration Sinusitis Consumer Zyprexa Weight Increased Health (Olanzapine) PS ORAL 15 MG/1 AT Professional BEDTIME Humulin-Human Insulin (Rdna): 30% Regular, 70% Nph SS 110 U DAY Lithium C Prilosec (Omeprazole) C Levothroid (Levothyroxine Sodium) C Avapro (Irbesartan) C Iron Supplement C Paxil (Paroxetine Hyidrochloride) C Lotensin (Benazepril Hydrochloride) C Desogestrel W/Ethinylestradiol C Buspar(Buspirone Hydrochloride) C Sarafem (Fluoxetine) C Effexor (Venlafaxine Hydrochloride) C Multivitamin C Date:12/21/04ISR Number: 4533594-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Risperdal PS OROPHARINGEAL Hospitalization - Blood Pressure Increased Risperdal SS OROPHARINGEAL Initial or Prolonged Blood Test Abnormal Halomonth SS Cachexia Olanzapine SS OROPHARINGEAL Cardiac Failure Acute Olanzapine SS OROPHARINGEAL Dehydration Cimetidine C Delusion Biperiden Diet Refusal Hydrochloride C Dyspnoea Isoleucine Leucine Eye Disorder Valine C Haematemesis Flunitrazepam C Hepatic Cirrhosis Zopiclone C Hyperhidrosis Sennoside C Hypoxia Aspartate Potassium C Loss Of Consciousness Neuroleptic Malignant Syndrome Pulmonary Oedema Respiratory Arrest Tremor Wheezing 24-Jun-2005 12:19 PM Page: 3303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/04ISR Number: 4537110-4Report Type:Expedited (15-DaCompany Report #MK200412-0154-1 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine Capsules Intentional Misuse Health (Strength Unk) PS Professional Quetiapine SS Olanzapine SS Date:12/21/04ISR Number: 4537318-8Report Type:Expedited (15-DaCompany Report #MK200411-0312-1 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Literature Oxycodone/Apap Health Tablets PS Professional Methadone And Olanzapine (Strengths, Doses And Therapy Dates Unk) SS Date:12/21/04ISR Number: 4537612-0Report Type:Expedited (15-DaCompany Report #MK200412-0015-1 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Literature Methadose Methadone Multiple Drug Overdose Health Hy Oral Con Usp PS Professional Alprazolam SS Olanzapine SS Date:12/21/04ISR Number: 4537741-1Report Type:Expedited (15-DaCompany Report #MK200411-0260-1 Age:62 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Hydrocodone/Apap PS Overdose Health Opioid SS Professional Olanzapine SS Date:12/21/04ISR Number: 4537793-9Report Type:Expedited (15-DaCompany Report #MK200411-0323-1 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propoxyphene Multiple Drug Overdose Health Napsylate/ Apap PS Professional Olanzapine SS Diphenhydramine SS Date:12/22/04ISR Number: 4535059-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-388966 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Lariam PS Roche ORAL Initial or Prolonged Tardive Dyskinesia Zyprexa SS ORAL 24-Jun-2005 12:19 PM Page: 3304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4535649-9Report Type:Direct Company Report #CTU 234908 E Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Abilify PS PLUS Hospitalization - Prescribed Overdose INJECTIONS 2 Initial or Prolonged Suicide Attempt X A DAY Disability Tooth Disorder 2001-2004 Other Zyprexa 40 Mg SS 3 X DAY Required 10/04-PRES Intervention to Risperdal 13 Mg SS Prevent Permanent Prolaxian 20 Mg SS Impairment/Damage Depakote 2500 SS Seraquel 800 Mg SS Cogentin 4 Mg SS Others SS Date:12/22/04ISR Number: 4538838-2Report Type:Expedited (15-DaCompany Report #USA040773147 Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Strattera Drug Ineffective Professional (Atomoxetine Headache Hydrochloride) PS 25 MG DAY Impulsive Behaviour Zyprexa-Oral Intraocular Pressure Test (Olanzapine) Abnormal (Olanzapine) SS 5 MG DAY Mydriasis Metadate Cd Obsessive-Compulsive (Methylphenidate Personality Disorder Hydrochloride) C Optic Atrophy Ddavp (Desmopressin Optic Nerve Cup/Disc Acetate) C Ratio Increased Photophobia Psychomotor Hyperactivity Pupils Unequal Tardive Dyskinesia Visual Field Defect Date:12/22/04ISR Number: 4538872-2Report Type:Expedited (15-DaCompany Report #US_0410106997 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Consumer Zyprexa-Oral Other Convulsion (Olanzapine) Drug Toxicity (Olanzapine) PS Date:12/22/04ISR Number: 4538873-4Report Type:Expedited (15-DaCompany Report #US_031299506 Age:26 YR Gender:Male I/FU:F Outcome PT Death Accidental Death Other Alcohol Use Dehydration Diabetic Hyperosmolar Coma Electrolyte Imbalance Fear Hallucinations, Mixed 24-Jun-2005 12:19 PM Page: 3305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperglycaemia Pancreatitis Pulmonary Congestion Report Source Product Role Manufacturer Route Dose Duration Therapeutic Agent Consumer Zyprexa-Oral Toxicity Health (Olanzapine) Professional (Olanzapine) PS 10 MG/2 Date:12/22/04ISR Number: 4538907-7Report Type:Expedited (15-DaCompany Report #US_0412108909 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Literature Zyprexa-Oral Hospitalization - Blood Creatine Health (Olanzapine) Initial or Prolonged Phosphokinase Increased Professional (Olanzapine) PS 10 MG DAY Blood Pressure Systolic Divalproex Sodium C Increased Blunted Affect Body Temperature Increased Catatonia Delusion Depressed Level Of Consciousness Encephalitis Herpes Fear Heart Rate Increased Hyperhidrosis Hypervigilance Mania Muscle Rigidity Mutism Neuroleptic Malignant Syndrome Paranoia Phagophobia Psychomotor Retardation Psychotic Disorder Respiratory Rate Increased Sedation Unresponsive To Verbal Stimuli Waxy Flexibility Date:12/22/04ISR Number: 4538921-1Report Type:Expedited (15-DaCompany Report #US_0412108992 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:12/22/04ISR Number: 4538922-3Report Type:Expedited (15-DaCompany Report #USA041285616 Age:50 YR Gender:Female I/FU:I Outcome PT Death Cardiac Disorder Other Chest Pain 24-Jun-2005 12:19 PM Page: 3306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Agent Toxicity Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Neurontin (Gabapentin) C Coumadin (Warfarin Sodium) C Tramadol C Citalopram C Date:12/22/04ISR Number: 4538924-7Report Type:Expedited (15-DaCompany Report #US_0412108962 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:12/22/04ISR Number: 4538925-9Report Type:Expedited (15-DaCompany Report #US_0412108988 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:12/22/04ISR Number: 4538935-1Report Type:Expedited (15-DaCompany Report #US_0412108999 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:12/22/04ISR Number: 4538937-5Report Type:Expedited (15-DaCompany Report #US_0412108995 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemangioma Consumer Zyprexa-Oral Other Pituitary Tumour Benign (Olanzapine) (Olanzapine) PS Date:12/22/04ISR Number: 4538939-9Report Type:Expedited (15-DaCompany Report #US_0412108950 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Diabetic Coma (Olanzapine) Diabetic Ketoacidosis (Olanzapine) PS Pancreatitis 24-Jun-2005 12:19 PM Page: 3307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4538940-5Report Type:Expedited (15-DaCompany Report #US_0412108869 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:12/22/04ISR Number: 4538948-XReport Type:Expedited (15-DaCompany Report #US_0412108876 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:12/22/04ISR Number: 4538951-XReport Type:Expedited (15-DaCompany Report #US_0405103231 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Consumer Zyprexa-Oral Hospitalization - Alcoholism Health (Olanzapine) Initial or Prolonged Antipsychotic Drug Level Professional (Olanzapine) PS 20 MG/2 DAY Increased Inderal(Propranolol Anxiety Hydrochloride) C Aphasia Lamictal Bradycardia (Lamotrigine) C Cardio-Respiratory Arrest Protonix Coma (Pantoprazole) C Confusional State Thiamine C Convulsion Normal Saline C Dyspnoea Ativan (Lorazepam) C Feeling Abnormal Tylenol Extra Hallucination Strength Heart Rate Increased (Paracetamol) C Hepatic Steatosis Amitriptyline C Hepatomegaly Diazepam C Infection Paxil (Paroxetine Mental Status Changes Hydrochloride) C Muscle Atrophy Depakote (Valproate Neuroleptic Malignant Semisodium) C Syndrome Zestril (Lisinopril) C Oedema Folate Sodium C Pulmonary Congestion Librium Rales (Chlordiazepoxide) C Renal Tubular Disorder Klonopin Rhabdomyolysis (Clonazepam) C Suicidal Ideation Multivitamin C Treatment Noncompliance Prilosec (Omeprazole Unresponsive To Pain Ratiopharm) C Stimuli Buspar (Buspirone Unresponsive To Verbal Hydrochloride) C Stimuli Vicon Forte C Weight Decreased Prednisone C Lorazepam C Propanolol C Liquibid D C Cephalexin C Temazepam C Benzonatate C 24-Jun-2005 12:19 PM Page: 3308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Augmentin C Hydroxyzine Pamoate C Mag-Ox (Magnesium Oxide) C Atenolol C Ery-Tab (Erythromycin) C Hydrocodone C Prevacid (Lansoprazole) C Date:12/22/04ISR Number: 4538953-3Report Type:Expedited (15-DaCompany Report #USA041285584 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG/1 DAY Zoloft (Sertraline Hydrochloride) C Seroquel C Date:12/22/04ISR Number: 4538977-6Report Type:Expedited (15-DaCompany Report #US_0412108880 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Hypertension (Olanzapine) Myocardial Infarction (Olanzapine) PS Weight Increased Date:12/22/04ISR Number: 4538980-6Report Type:Expedited (15-DaCompany Report #US_0412108882 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Zyprexa-Oral Pancreatitis (Olanzapine) Weight Increased (Olanzapine) PS Date:12/22/04ISR Number: 4538982-XReport Type:Expedited (15-DaCompany Report #USA041285251 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Health Zyprexa-Oral Other Professional (Olanzapine) Company (Olanzapine) PS 5 MG/1 DAY Representative Date:12/22/04ISR Number: 4538983-1Report Type:Expedited (15-DaCompany Report #USA041285469 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4538984-3Report Type:Expedited (15-DaCompany Report #USA041285564 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatotoxicity Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other (Olanzapine) PS Date:12/22/04ISR Number: 4538998-3Report Type:Expedited (15-DaCompany Report #USA041285291 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Zyprexa-Oral Initial or Prolonged Increased Professional (Olanzapine) PS 5 MG 1 DAY Hallucination Company Cardura (Doxazosin) C Representative Date:12/22/04ISR Number: 4539000-XReport Type:Expedited (15-DaCompany Report #USA041285103 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antisocial Behaviour Consumer Zyprexa-Oral Initial or Prolonged Coma (Olanzapine) PS 5 MG Other Dysarthria Thyroid C Fatigue Vitamins C Hypotension Aspirin Increased Appetite (Acetylsalicylic Nausea Acid) C Sedation Tylenol C Therapeutic Response Unexpected Date:12/22/04ISR Number: 4539001-1Report Type:Expedited (15-DaCompany Report #USA041284992 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Health Zyprexa-Oral Skin Haemorrhage Professional (Olanzapine) PS 5 MG/1 DAY Treatment Noncompliance Baby Asirin (Acetylsalicylic Acid) C Remeron (Mirtazapine Orifarm) C Lisinopril (Lisinopril) C Lipitor (Atorvastatin Calcium) C Prilosec (Omeprazole Ratiopharm) C Date:12/22/04ISR Number: 4539002-3Report Type:Expedited (15-DaCompany Report #USA040876447 Age:33 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Condition Aggravated Schizoaffective Disorder 24-Jun-2005 12:19 PM Page: 3310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/1 AT BEDTIME Risperidone C Date:12/22/04ISR Number: 4539003-5Report Type:Expedited (15-DaCompany Report #USA041285609 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) PS Other Company Desyrel (Trazodone Representative Hydrochloride) C Date:12/22/04ISR Number: 4539017-5Report Type:Expedited (15-DaCompany Report #US_0412108917 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Zyprexa-Oral Initial or Prolonged Cerebral Atrophy (Olanzapine) Cerebrovascular Accident (Olanzapine) PS 20 MG Fall Wellbutrin Hypertension (Bupropion Hypotension Hydrochloride) C Irritability Procrit Knee Operation (Erythropoietin) C Screaming Iron C Speech Disorder Depakote (Valproate Semisodium) C Folic Acid C Mvi C Vasotec (Enalapril Maleate0 C Benadryl C Insulin C 'Artisone' C Diabeta (Glibenclamide0 C Miacalcin (Calcitonin, Salmon) C Calcium C Glucerna C 'Nanone' C Date:12/22/04ISR Number: 4539028-XReport Type:Expedited (15-DaCompany Report #US_0406103675 Age:49 YR Gender:Female I/FU:F Outcome PT Hospitalization - Amnesia Initial or Prolonged Anger Other Anxiety Apathy Bipolar Disorder Blood Glucose Fluctuation 24-Jun-2005 12:19 PM Page: 3311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Glucose Increased Condition Aggravated Contusion Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Non-Insulin-Dependent (Olanzapine) PS 45 MG AT Disturbance In Attention BEDTIME Diverticulitis Ability Dizziness (Aripiprazole) C Dysuria Wellbutrin Sr Fall (Bupropion Fatigue Hydrochloride) C Fear Paxil (Paroxetine Flat Affect Hydrochloride) C Hallucination Antabuse Headache (Disulfiram) C Hypercholesterolaemia Spironolactone(Spiro Hyperphagia nolactone) C Hypersomnia Lithium Carbonate C Hypotension Lisinopril Injury (Lisinopril) C Insomnia Atorvastatin C Loss Of Consciousness Metformin C Major Depression Risperdal Medication Error (Risperidone) C Micturition Urgency Vitamin B12 C Muscle Spasms Zantac (Ranitidine Muscle Twitching Hydrochloride) C Nightmare Bactrim C Polysubstance Abuse Erythromycin Prescribed Overdose (Erythromycin) C Self Mutilation Vistaril(Hydroxyzine Self-Medication Embonate) C Suicidal Ideation Syncope Thermal Burn Thinking Abnormal Tremor Visual Disturbance Weight Increased Date:12/22/04ISR Number: 4539224-1Report Type:Expedited (15-DaCompany Report #8008315 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Keppra PS ORAL 250 MG 2/D PO Initial or Prolonged Agitation Health Imovane SS ORAL 7.5 MG 2/D PO Convulsion Professional Zyprexa SS ORAL 5 MG /D PO Delirium Other Depakine Chrono SS ORAL 1000 MG/ D PO Expressive Language Depakine Chrono SS ORAL 500 MG 4/D PO Disorder Rivotril SS ORAL PO Hallucination, Visual Rivotril SS ORAL 30 GTT /D PO Date:12/22/04ISR Number: 4539517-8Report Type:Expedited (15-DaCompany Report #FR_041205360 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Other Angioneurotic Oedema Foreign Health 24-Jun-2005 12:19 PM Page: 3312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 10 MG DAY Norset (Mirtazapine Orifarm) C Myolastan (Terazepam) C Rivotril (Clonazepam) C Date:12/22/04ISR Number: 4539519-1Report Type:Expedited (15-DaCompany Report #FR_041205361 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Foreign Zyprexa-Oral Initial or Prolonged Cerebral Infarction Health (Olanzapine) PS 2 DSG FORM Drug Abuser Professional DAY Hemianopia Homonymous Other Systolic Hypertension Date:12/22/04ISR Number: 4539525-7Report Type:Expedited (15-DaCompany Report #FR_041205371 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Foreign Zyprexa-Oral Increased Health (Olanzapine) PS 20 MG DAY Completed Suicide Professional Effexor Condition Aggravated Other (Venlaffaxine Delirium Hydrochloride) C Injury Asphyxiation Xanax (Alprazolam) C Schizophrenia Date:12/22/04ISR Number: 4539529-4Report Type:Expedited (15-DaCompany Report #EWC041241723 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Foreign Olanzapine-Oral Initial or Prolonged Dementia Literature (Olanzapine) PS 5 MG Drug Ineffective Health Nortriptyline Therapy Non-Responder Professional (Nortiptyline Hydrochloride) SS 40 MG Date:12/22/04ISR Number: 4539541-5Report Type:Expedited (15-DaCompany Report #JP_041205365 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 5 MG/1 DAY Professional Hirnamin Other (Levomepromazine) C Tasmolin (Biperiden) C Halcion (Triazolam) C Lendormin 24-Jun-2005 12:19 PM Page: 3313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Brotizolam) C Doral (Quazepam) C Date:12/22/04ISR Number: 4540152-6Report Type:Expedited (15-DaCompany Report #GBS041216099 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Foreign Olanzapine-Oral Decreased Health (Olanzapine) PS 10 MG Professional Haloperidol C Other Lorazepam C Date:12/22/04ISR Number: 4540154-XReport Type:Expedited (15-DaCompany Report #EWC041241773 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa-Oral Other Drug Abuser Health (Olanzapine) Drug Level Above Professional (Olanzapine) PS Therapeutic Other Date:12/22/04ISR Number: 4540156-3Report Type:Expedited (15-DaCompany Report #EWC041241809 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Health (Olanzapine) Syncope Professional (Olanzapine) PS 10 MG/1 DAY Company Trilafon Representative (Perphenazine Other Enantate) C Date:12/22/04ISR Number: 4540158-7Report Type:Expedited (15-DaCompany Report #JP_041105223 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Difficulty In Walking Health (Olanzapine) Fall Professional (Olanzapine) PS 10 MG DAY Nausea Company Predonine Vomiting Representative (Prednisolone) C Other Laxoberon (Sodium Picosulfate) C Bayaspirin (Acetylsalicylic Acid) C Depakene (Valproate Sodium) C Maglax (Magnesium Oxide) C Sepazon (Cloxazolam) C Levotomin (Levomepromazine Maleate) C Doral (Quazepam) C Myslee (Zolpidem Tartrate) C Pursennid C 24-Jun-2005 12:19 PM Page: 3314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4540159-9Report Type:Expedited (15-DaCompany Report #JP_041205358 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pleural Effusion Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Date:12/22/04ISR Number: 4540162-9Report Type:Expedited (15-DaCompany Report #JP_041205345 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Polydipsia Foreign Zyprexa-Oral Initial or Prolonged Study (Olanzapine) Health (Olanzapine) PS 5 MG/1 DAY Professional Other Date:12/22/04ISR Number: 4540166-6Report Type:Expedited (15-DaCompany Report #GBS041216119 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Septal Defect Foreign Olanzapine-Oral Hospitalization - Cardiovascular Disorder Health (Olanzapine) PS 2.5 MG Initial or Prolonged Cerebrovascular Accident Professional Paroxetine C Other Circulatory Collapse Other Deep Vein Thrombosis Influenza Like Illness Myocardial Infarction Pulmonary Embolism Pulmonary Hypertension Date:12/22/04ISR Number: 4540178-2Report Type:Expedited (15-DaCompany Report #FR_040904885 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zyprexa-Oral Initial or Prolonged Prescribed Overdose Health (Olanzapine) Other Subcutaneous Abscess Professional (Olanzapine) PS 10 MG/3 DAY Other Haldol (Haloperidol Decanoate) C Zoloft (Sertraline Hydrochloride) C Date:12/22/04ISR Number: 4540363-XReport Type:Expedited (15-DaCompany Report #JP_041004698 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Hypersensitivity Foreign Zyprexa-Oral Hospitalization - Photosensitivity Reaction Health (Olanzapine) PS 10 MG DAY Initial or Prolonged Skin Test Positive Professional Depakene (Valproate Company Sodium) C Representative Limas (Lithium Other Carbonate) C Furosemide (Furosemide) C Magnesium Oxide C 24-Jun-2005 12:19 PM Page: 3315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4540365-3Report Type:Expedited (15-DaCompany Report #FR_040704436 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Prolonged Health (Olanzapine) PS 20 MG DAY False Positive Laboratory Professional Tegretol Result Company (Carbamazepine) C Representative Seresta (Oxazepam) C Other Zoloft (Sertraline Hydrochloride) C Imovane (Zopiclone) C Date:12/22/04ISR Number: 4540382-3Report Type:Expedited (15-DaCompany Report #AU_041208231 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Olanzapine-Oral Hospitalization - Drug Toxicity Health (Olanzapine) PS 30 MG/1 DAY Initial or Prolonged Influenza Like Illness Professional Valium (Diazepam) C Injury Asphyxiation Company Sedation Representative Other Date:12/22/04ISR Number: 4545313-8Report Type:Periodic Company Report #USA040567263 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Prozac-Oral Initial or Prolonged Blindness (Fluoxetine) Other Blood Glucose Increased (Fluoxetine Blood Pressure Decreased Hydrochloride) PS 80 MG/DAY 6 YR Convulsion Humulin-Human Diabetes Mellitus Insulin (Rdna): 30% Dyspepsia Regular, 70% Nph(H SS 78 U DAY Hypoaesthesia Humalog-.(Lispro) SS Loss Of Consciousness Zyprexa-Oral Nausea (Olanzapine) Pain (Olanzapine) SS Pollakiuria Dilantin (Phenytoin Vision Blurred Sodium) C Weight Increased Tegretol (Carbamazepine) C Risperidone C Ativan (Lorazepam) C Vioxx (Rofecoxib) C Centrum A To Zinc C Date:12/23/04ISR Number: 4536145-5Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0406391A Age: Gender:Male I/FU:F Outcome PT Other Acquired Porphyria Aggression Agitation Akathisia Amnesia Arthralgia Asthenia 24-Jun-2005 12:19 PM Page: 3316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bipolar Disorder Body Temperature Fluctuation Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Wellbutrin PS Glaxosmithkline ORAL 42 DAY Crying Tranquilizer SS Depression Depakote SS Disability Zyprexa SS Dizziness Alcohol C Dysarthria Dysphemia Dyspnoea Electric Shock Emotional Disorder Encephalopathy Facial Palsy Fatigue Feeling Abnormal Headache Hyperaesthesia Hypersensitivity Hypoxia Immune System Disorder Injury Insomnia Intentional Self-Injury Mania Mastocytosis Metabolic Encephalopathy Muscle Spasms Myalgia Myoclonus Nervous System Disorder Nightmare Overdose Pain Of Skin Petit Mal Epilepsy Suicidal Ideation Suicide Attempt Throat Tightness Tremor Vestibular Disorder Vomiting Date:12/23/04ISR Number: 4538114-8Report Type:Direct Company Report #CTU 234981 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Zyprexa 10mg Eli Required Non-Insulin-Dependent Lilly PS Eli Lilly ORAL 10MG 1X PER Intervention to Vaginal Haemorrhage DAY ORAL Prevent Permanent Weight Decreased Clonazipam C Impairment/Damage Wellbutrin C Effexor C Seroquel C Buspar C Thyroid Hormone C 24-Jun-2005 12:19 PM Page: 3317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/04ISR Number: 4539424-0Report Type:Expedited (15-DaCompany Report #US_0412109210 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Insulin-Dependent (Olanzapine) Hepatic Steatosis (Olanzapine) PS Pancreatitis Date:12/23/04ISR Number: 4539902-4Report Type:Expedited (15-DaCompany Report #USA041285635 Age:98 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Symbyax-Olanzapine Initial or Prolonged Atrioventricular Block Professional 6mg/Fluoxetine 25mg Other Fall Company (Olanzapin PS Head Injury Representative Hepatic Enzyme Increased Loss Of Consciousness Renal Impairment Syncope Date:12/27/04ISR Number: 4539510-5Report Type:Direct Company Report #CTU 235102 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Symbyax PS ORAL ORAL 25/6.25 Chest Pain Avandamet 2/500 C Dyspnoea Topamax C Oedema Peripheral Sensation Of Heaviness Date:12/27/04ISR Number: 4541631-8Report Type:Expedited (15-DaCompany Report #2004110268 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Foreign Xanax Tablet Life-Threatening Above Therapeutic Health (Alprazolam) PS ORAL 1.5 MG (0.5 Bradycardia Professional MG, 1 IN 3 Cardiac Arrest D), ORAL Cardio-Respiratory Arrest Olanzapine Cardiopulmonary Failure (Olanzapine) SS ORAL 10 MG (10 MG, Flatulence INTERVAL: Glasgow Coma Scale EVERY DAY), Abnormal ORAL Hyperkalaemia Ileus Poisoning Deliberate Renal Failure Rhabdomyolysis Vomiting Date:12/27/04ISR Number: 4541771-3Report Type:Expedited (15-DaCompany Report #2004094537 Age:89 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Confusional State 24-Jun-2005 12:19 PM Page: 3318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypercapnia Lung Disorder Malnutrition Report Source Product Role Manufacturer Route Dose Duration Mental Disorder Foreign Alprazolam Respiratory Failure Health (Alprazolam) PS ORAL ORAL Somnolence Professional Venlafaxine Superinfection Lung (Venlafaxine) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Omeprazole (Omeprzole) C ORAL ORAL Date:12/28/04ISR Number: 4541125-XReport Type:Expedited (15-DaCompany Report #US_0406103675 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Zyprexa-Oral Initial or Prolonged Anger Health (Olanzapine) Other Anxiety Professional (Olanzapine) PS 45 MG AT Apathy BEDTIME Bipolar Disorder Abilify Contusion (Aripiprazole) C Cystitis Wellbutrin Sr Depression (Bupropion Diabetes Mellitus Hydrochloride) C Non-Insulin-Dependent Paxil (Paroxetine Disturbance In Attention Hydrochloride) C Diverticulitis Antabuse Dizziness (Disulfiram) C Drug Abuser Spironolactone Fatigue (Spironolactone) C Fear Lithium Carbonate C Formication Lisinopril Hallucination, Auditory (Lisinopril) C Headache Atorvastatin C Hypercholesterolaemia Metformin C Hypotension Risperdal Injury (Risperidone) C Insomnia Vitamin B12 C Loss Of Consciousness Zantac (Ranitidine Major Depression Hydrochloride) C Muscle Spasms Bactrim C Muscle Twitching Erythromycin Nervousness (Erythromycin) C Nightmare Vistaril Panic Disorder (Hydroxyzine Pneumonia Embonate) C Polysubstance Abuse Prescribed Overdose Self Mutilation Self-Injurious Ideation Suicidal Ideation Thermal Burn Urinary Tract Infection Visual Disturbance Weight Increased 24-Jun-2005 12:19 PM Page: 3319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/04ISR Number: 4541233-3Report Type:Expedited (15-DaCompany Report #US_0407104230 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Consumer Zyprexa-Oral Initial or Prolonged Abscess Limb Health (Olanzapine) Alanine Aminotransferase Professional (Olanzapine) PS 20 MG DAY Increased Paxil (Paroxetine Bacterial Infection Hydrochloride) C Blood Alkaline Trazadone Phosphatase Increased (Trazodone) C Blood Cholesterol Elavil Abnormal (Amitriptyline Blood Sodium Decreased Hydrochloride) C Cellulitis Glyburide C Culture Wound Positive Metformin C Diabetes Mellitus Regular Insulin Genital Pruritus Female (Insulin) C Glycosylated Haemoglobin Prozac (Fluoxetine Increased Hydrochloride) C Hyperglycaemia Fluoxetine C Osteomyelitis Refusal Of Treatment By Patient Tinea Cruris Ulcer Vaginal Pain Vision Blurred Vulval Disorder Date:12/29/04ISR Number: 4540716-XReport Type:Expedited (15-DaCompany Report #200414332FR Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Daonil PS Aventis Pharmaceuticals Inc. ORAL Zyprexa SS ORAL Befizal SS ORAL Tercian C ORAL Date:12/29/04ISR Number: 4540891-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0406391A Age: Gender:Male I/FU:F Outcome PT Other Acquired Porphyria Aggression Agitation Akathisia Amnesia Arthralgia Asthenia Bipolar Disorder Body Temperature Fluctuation Coordination Abnormal Crying Depression Disability Dizziness Dysarthria 24-Jun-2005 12:19 PM Page: 3320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysphemia Dyspnoea Electric Shock Report Source Product Role Manufacturer Route Dose Duration Emotional Disorder Wellbutrin PS Glaxosmithkline ORAL 42 DAY Encephalopathy Tranquilizer SS Facial Palsy Depakote SS Fatigue Zyprexa SS Feeling Abnormal Alcohol C Headache Hyperaesthesia Hypersensitivity Hypoxia Immune System Disorder Injury Insomnia Intentional Self-Injury Mania Mastocytosis Metabolic Encephalopathy Muscle Spasms Myalgia Myoclonus Nervous System Disorder Nightmare Overdose Pain Of Skin Petit Mal Epilepsy Schizoaffective Disorder Suicidal Ideation Suicide Attempt Throat Tightness Tremor Vestibular Disorder Vomiting Date:12/29/04ISR Number: 4543123-9Report Type:Expedited (15-DaCompany Report #2004-122313-NL Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Mirtazapine PS ORAL 45 MG ORAL Initial or Prolonged Labile Blood Pressure Professional Olanzapine SS ORAL 10 MG ORAL 59 DAY Major Depression Sulpiride SS ORAL 400 MG ORAL 1 WK Neuroleptic Malignant Citalopram C Syndrome Date:01/03/05ISR Number: 4543484-0Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0359117A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Paracetamol PS Glaxosmithkline 1 DAY Initial or Prolonged Intentional Misuse Efexor SS 1 DAY Multiple Drug Overdose Olanzapine SS 1 DAY Suicide Attempt Alcohol SS 24-Jun-2005 12:19 PM Page: 3321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/05ISR Number: 4543916-8Report Type:Expedited (15-DaCompany Report #GXKR2003GB00518 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Metoclopramide (Ngx) Initial or Prolonged Anaemia Health (Metoclopramide) PS ORAL 10 MG, TID, Disability Coordination Abnormal Professional ORAL Other Leukopenia Other Olanzapine Muscle Rigidity (Olanzapine) SS ORAL 15 MG, QD, Somnolence ORAL Thrombocytopenia Ritonavir (Ritonavir) C Lamivudine (Lamivudine) C Azithromycin (Azithromycin) C Fluconazole (Fluconazole) C Methadone (Methadone) C Lansoprazole (Lansoprazole) C Lactulose (Lactulose) C Thiamine (Thiamine) C Tenofovir Disoproxil Fumarate (Tenofovir Disoproxil Fumarate) C Fosamprenavir (Fosamprenavir) C Date:01/03/05ISR Number: 4545592-7Report Type:Expedited (15-DaCompany Report #USA041183296 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine 6 Overdose Professional Mg/ Fluoxetine 25mg Company (Olanzapin PS Representative Klonopin (Clonazepam) C Percocet C Date:01/03/05ISR Number: 4545707-0Report Type:Direct Company Report #CTU 235544 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Carbamazepine 200 Other Neutropenia Mg/500 Mg PS ORAL 200 MG BID; 500 MG TID PO Olanzapine 15mg SS ORAL 15 MG QD PO Date:01/03/05ISR Number: 4545725-2Report Type:Expedited (15-DaCompany Report #USA041285345 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Benign Cardiac Neoplasm Consumer Zyprexa-Oral Hospitalization - Cerebrovascular Accident (Olanzapine) PS Initial or Prolonged Intracardiac Thrombus Zoloft (Sertraline Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serzone (Nefazodone Hydrochloride) C Date:01/03/05ISR Number: 4545738-0Report Type:Expedited (15-DaCompany Report #USA041286385 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Zyprexa-Oral Life-Threatening Professional (Olanzapine) Hospitalization - Company (Olanzapine) PS 20 MG Initial or Prolonged Representative Other Date:01/03/05ISR Number: 4545799-9Report Type:Expedited (15-DaCompany Report #US_0412109304 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:01/03/05ISR Number: 4545800-2Report Type:Expedited (15-DaCompany Report #US_0412109277 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:01/03/05ISR Number: 4545802-6Report Type:Expedited (15-DaCompany Report #US_0412109137 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Health Olanzapine-Oral Initial or Prolonged Thrombocytopenic Purpura Professional (Olanzapine) PS 2.5 MG AT Other BEDTIME Gabapentin C Date:01/03/05ISR Number: 4545804-XReport Type:Expedited (15-DaCompany Report #US_0407104490 Age:44 YR Gender:Female I/FU:I Outcome PT Other Abdominal Pain Upper Adrenal Disorder Anxiety Blood Cholesterol Abnormal Blood Creatine Phosphokinase Increased Blood Oestrogen Decreased Blood Pressure Increased Blood Triglycerides Increased Blood Urea Decreased Chest Discomfort Cholelithiasis 24-Jun-2005 12:19 PM Page: 3323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Constipation Diabetes Mellitus Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Zyprexa-Oral Dizziness Health (Olanzapine) Fatigue Professional (Olanzapine) PS 15 MG Food Craving Keplex (Cefalexin Hallucination, Auditory Monohydrate) C Headache Multivitamins Nos Hormone Level Abnormal (Multivitamins Nos) C Hypersomnia Geodon (Ziprasidone Hyperventilation Hydrochloride) C Hypoaesthesia Quetiapine C Increased Appetite Risperidone C Injection Site Haloperidol C Haemorrhage Navane (Tiotixene) C Leukocytosis Depakote (Valproate Mediastinal Disorder Semisodium) C Menorrhagia Bupropion C Monocyte Count Increased Celexa (Citalopram Nausea Hydrobromide) C Neuropathy Symbyax C Osteoporosis Paxil (Paroxetine Ovarian Cyst Hydrochloride) C Pain Venlafaxine C Pancreatitis Trazodone Panic Attack (Trazodone) C Pco2 Decreased Luvox (Fluvoxamine Peptic Ulcer Maleate) C Premenstrual Syndrome Insulin C Refusal Of Treatment By Oral Contraceptive Patient Nos C Sexual Activity Increased Lorazepam C Skin Burning Sensation Alprazolam C Somnolence Artane Tachycardia (Trihexyphenidyl Tearfulness Hydrochloride) C Umbilical Hernia Depo Provera Urinary Incontinence (Medroxyprogesterone Urticaria Acetate) C Weight Increased Date:01/03/05ISR Number: 4545806-3Report Type:Expedited (15-DaCompany Report #USA041286271 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Zyprexa-Oral Circulatory Collapse Professional (Olanzapine) Metabolic Syndrome Company (Olanzapine) PS 20 MG Representative Date:01/03/05ISR Number: 4545922-6Report Type:Expedited (15-DaCompany Report #US_0412109086 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Injury Other Platelet Count Increased Schizophrenia 24-Jun-2005 12:19 PM Page: 3324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) Other (Olanzapine) PS 20 MG DAY Losartan C Docusate Sodium C Ferrous Sulfate (Ferrous Sulfate) C Trazadone (Trazodone) C Chlorpromazine C Venlafaxine Hydrochloride C Mirtazapine C Clozapine C Abilify (Aripiprazole) C Date:01/03/05ISR Number: 4545927-5Report Type:Expedited (15-DaCompany Report #US_0412109451 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:01/03/05ISR Number: 4546086-5Report Type:Expedited (15-DaCompany Report #US_0405103231 Age:42 YR Gender:Male I/FU:F Outcome PT Death Accidental Death Hospitalization - Alcoholism Initial or Prolonged Anxiety Aphasia Blood Creatine Phosphokinase Increased Body Temperature Increased Bradycardia Cardio-Respiratory Arrest Coma Confusional State Convulsion Dyspnoea Feeling Abnormal Hallucination Hepatic Steatosis Hepatomegaly Infection Mental Status Changes Muscle Atrophy Neuroleptic Malignant Syndrome Pulmonary Congestion Pulmonary Oedema Pupil Fixed Pyrexia 24-Jun-2005 12:19 PM Page: 3325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Tubular Disorder Rhabdomyolysis Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Unresponsive To Pain Consumer Zyprexa-Oral Stimuli Health (Olanzapine) Weight Decreased Professional (Olanzapine) PS 20 MG/2 DAY Inderal (Propranol Hydrochloride) C Lamictal (Lamotrigine) C Protonix (Pantoprazole) C Thiamine C Normal Saline C Ativan (Lorazepam) C Tylenol Extra Strength (Paracetamol) C Amitriptyline C Diazepam C Paxil (Paroxetine Hydrochloride) C Depakote (Valproate Semisodium) C Zestril (Lisinopril) C Folate Sodium C Librium (Chlordiazepoxide) C Klonopin (Clonazepam) C Multivitamin C Prilosec (Omeprazole Ratiopharm) C Buspar (Buspirone Hydrochloride) C Vicon Forte C Prednisone C Lorazepam C Propranol C Liquibid D C Cephalexin C Temazepam C Benzonatate C Augmentin C Hydroxyzine Pamoate C Mag-Ox (Magnesium Oxide) C Atenolol C Ery-Tab (Erythromycin) C Hydrocodone C Prevacid (Lansoprazole) C Date:01/03/05ISR Number: 4546088-9Report Type:Expedited (15-DaCompany Report #USA041184443 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa-Oral Overdose Professional (Olanzapine) 24-Jun-2005 12:19 PM Page: 3326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS 10 M/2/DAY Alupent (Orcipranaline Sulfate) C Imipramine C Neurontin (Gabapentin Pfizer) C Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Darvocet-N C Norvasc (Amlodipine) C Date:01/03/05ISR Number: 4546097-XReport Type:Expedited (15-DaCompany Report #US_991029935 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Abnormal Behaviour Health (Olanzapine Other Accidental Needle Stick Professional (Olanzapine) PS 20 MG/DAY Alcohol Poisoning Humalog (Insulin Asthenia Lispro) C Conjunctivitis Depakote (Valproate Diabetes Mellitus Semisodium) C Inadequate Control Klonopin Diabetes Mellitus (Clonazepam) C Insulin-Dependent Lamictal Diabetic Ketoacidosis (Lamotrigine) C Drug Dependence Celexa (Citalopram Feeling Abnormal Hydrobromide) C Flat Affect Temazepam C Hyperphagia Celecoxib C Legal Problem Clindamycin C Mania Hydrocodone Myalgia Bitartrate C Sinus Tachycardia Methylprednisolone C Ventricular Hypertrophy Cephalexin C Erythromycin (Erythromycin) C Guaifenesin (Guaifenesin L.A.) C Disopyramide Phosphate) C Captopril C Ciprofloxacin C Omeprazole C Nystatin C Azithromycin C Lortab C Fluvoxamine C Date:01/03/05ISR Number: 4546103-2Report Type:Expedited (15-DaCompany Report #USA040671193 Age:14 YR Gender:Male I/FU:F Outcome PT Other Abnormal Behaviour Chest Pain Haematemesis 24-Jun-2005 12:19 PM Page: 3327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemoptysis Nasopharyngitis Nipple Pain Report Source Product Role Manufacturer Route Dose Duration Nipple Swelling Consumer Strattera Somnolence Health (Atomoxetine Weight Increased Professional Hydrochloride) PS 60 MG DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG DAY Adderall C Concerta (Methylphenidate Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:01/03/05ISR Number: 4546392-4Report Type:Expedited (15-DaCompany Report #FR_041205456 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Representative Other Date:01/03/05ISR Number: 4546418-8Report Type:Expedited (15-DaCompany Report #GBS041216161 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Foreign Olanzapine-Oral Constipation Consumer (Olanzapine) PS 10 MG/2 DAY Neuromyopathy Other Clopidogrel C Date:01/03/05ISR Number: 4546420-6Report Type:Expedited (15-DaCompany Report #FR_041205409 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Foreign Zyprexa-Oral Consumer (Olanzapine) Other (Olanzapine) PS Date:01/03/05ISR Number: 4546424-3Report Type:Expedited (15-DaCompany Report #FR_041205422 Age:92 YR Gender:Male I/FU:I Outcome PT Death Aphagia Hospitalization - Blood Urea Increased Initial or Prolonged Coma Other Decubitus Ulcer Dysstasia General Physical Health Deterioration Prostatic Specific Antigen Increased Pyrexia 24-Jun-2005 12:19 PM Page: 3328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Regressive Behaviour Staphylococcal Infection Transaminases Increased Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa-Oral Increased Consumer (Olanzapine) Other (Olanzapine) PS 15 MG DAY Lysanxia (Prazepam) C Date:01/03/05ISR Number: 4546429-2Report Type:Expedited (15-DaCompany Report #EWC041241717 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa-Oral Other Bladder Cancer Health (Olanzapine) Confusional State Professional (Olanzapine) PS 5 MG/2 DAY Feeding Disorder Company Diazepam C Hyperglycaemia Representative Neurontin Hyperkalaemia Other (Gabapentin Pfizer) C Irritability Rexer (Mirtazapine Sedation Orifarm) C Speech Disorder Seropram (Cytalopram Sudden Death Hydrobromide) C Syncope Urinary Tract Infection Date:01/03/05ISR Number: 4546432-2Report Type:Expedited (15-DaCompany Report #EWC041241932 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chondrocalcinosis Foreign Olanzapine-Oral Neutropenia Health (Olanzapine) PS 2.5 MG DAY Pain Professional Celebrex (Celecoxib) C Other Rivotril (Clonazepam) C Sintrom (Acenocoumarol) C Paracetamol C Venlafaxine C Imovane (Zopiclone) C Date:01/03/05ISR Number: 4546435-8Report Type:Expedited (15-DaCompany Report #JP_041205399 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Head Injury Foreign Zyprexa-Oral Road Traffic Accident Study (Olanzapine) Subdural Haematoma Health (Olanzapine) PS 10 MG DAY Professional Cercine (Diazepam) C Akineton (Biperiden Lactate) C Silece (Flunitrazepam) C Adalat (Nifedipine Pa) C Lasix (Furosemide) C Artist (Carvedilol) C Diovan (Valsartan) C Bayaspirin 24-Jun-2005 12:19 PM Page: 3329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetylsalicylic Acid) C Warfarin C Isosorbide Dinitrate C Gaster (Famotidine) C Slow-K (Potassium Chloride) C Magnesium Oxide C Date:01/03/05ISR Number: 4546469-3Report Type:Expedited (15-DaCompany Report #DE_041214925 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:01/03/05ISR Number: 4546473-5Report Type:Expedited (15-DaCompany Report #US_0412109502 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Consumer Zyprexa-Oral Drug Toxicity (Olanzapine) (Olanzapine) PS Methadone (Methadone) C Date:01/03/05ISR Number: 4546482-6Report Type:Expedited (15-DaCompany Report #EWC040238032 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Olanzapine-Oral First Degree Health (Olanzapine) PS 20 MG/IN THE Electrocardiogram Pr Professional EVENING Prolongation Company Risperidone C Hypertension Representative Other Date:01/03/05ISR Number: 4546490-5Report Type:Expedited (15-DaCompany Report #EWC041141420 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Foreign Zyprexa-Oral Initial or Prolonged Leukaemia Health (Olanzapine) Pancytopenia Professional (Olanzapine) PS 20 MG/1 DAY Pyrexia Other Stelazine (Trifluoperazine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/05ISR Number: 4546561-3Report Type:Expedited (15-DaCompany Report #US_0412109445 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Hypertension (Olanzapine) Myocardial Infarction (Olanzapine) PS Pancreatitis Weight Increased Date:01/03/05ISR Number: 4546592-3Report Type:Expedited (15-DaCompany Report #AU_041208231 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Olanzapine Hospitalization - Influenza Like Illness Health (Olanzapine) PS ORAL 30 MG/1 DAY Initial or Prolonged Interstitial Lung Disease Professional Valium (Diazepam) C Pulmonary Alveolar Company Benztropine C Haemorrhage Representative Antenex (Diazepam) C Pulmonary Congestion Other Zoloft (Sertraline Pulmonary Fibrosis Hydrochloride) C Respiratory Arrest Sedation Teratoma Date:01/03/05ISR Number: 4546594-7Report Type:Expedited (15-DaCompany Report #EWC041241636 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Foreign Zyprexa-Dispersible Rash Health (Olanzapine) Skin Exfoliation Professional (Olanzapine) PS 15 MG DAY Company Lorazepam C Representative Hydroxyzine Other Hydrochloride C Flurazepam C Folic Acid C Vitamin B12 C Date:01/03/05ISR Number: 4546598-4Report Type:Expedited (15-DaCompany Report #JP_041004909 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Study (Olanzapine) Other Aspartate Health (Olanzapine) PS 5 MG DAY Aminotransferase Professional Lodopin (Zotepine) C Increased Other Cercine (Diazepam) C Blood Alkaline Halcion (Triazolam) C Phosphatase Increased Depas (Etizolam) C Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased 24-Jun-2005 12:19 PM Page: 3331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/05ISR Number: 4546662-XReport Type:Expedited (15-DaCompany Report #2004AL000891 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Literature Children'S Apap Hospitalization - Acute Respiratory Health Elixir Initial or Prolonged Distress Syndrome Professional (Acetaminophen) Alanine Aminotransferase (Alpharma) PS Alpharma ORAL PO Increased Infants' Apap Drops Arrhythmia (Acetaminophen) Aspartate (Alpharma) SS Alpharma ORAL PO Aminotransferase Olanzapine SS ORAL PO Increased Buspirone SS ORAL PO Blood Calcium Decreased Gabapentin Capsules, Cardiac Arrest 100 Mg, 300 Mg & 400 Coagulopathy Mg (Purepac) SS Purepac ORAL PO Coma Gabapentin Tablets, Compartment Syndrome 600 Mg & 800 Mg Completed Suicide (Purepac) SS Purepac ORAL PO Haemodialysis Paroxetine SS ORAL PO Hypotension Levothyroxine SS ORAL PO Intentional Misuse Estrogens SS ORAL PO Labile Blood Pressure Procedural Complication Renal Failure Date:01/05/05ISR Number: 4546663-1Report Type:Expedited (15-DaCompany Report #2004AL000892 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Literature Children'S Apap Hospitalization - Increased Health Elixir Initial or Prolonged Aspartate Professional (Acetaminophen) Aminotransferase (Alpharma) PS Alpharma ORAL PO Increased Infants' Apap Drops Bilirubin Conjugated (Acetaminophen) Increased (Alpharma) SS Alpharma ORAL PO Blood Bilirubin Increased Olanzapine SS ORAL PO Brain Herniation Trazodone C Coma Trazodone C Completed Suicide Topiramate C Dialysis Valproic Acid C Drug Ineffective Electrocardiogram Qt Corrected Interval Prolonged Haemorrhage Intracranial International Normalised Ratio Increased Multiple Drug Overdose Vomiting Date:01/05/05ISR Number: 4546696-5Report Type:Expedited (15-DaCompany Report #S04-UKI-07616-01 Age:46 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Body Temperature Increased 24-Jun-2005 12:19 PM Page: 3332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extrapyramidal Disorder Hyperhidrosis Labile Blood Pressure Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Foreign Cipramil Syndrome Health (Citalopram) PS ORAL 20 MG QD PO Parkinson'S Disease Professional Olanzapine SS ORAL 10 MG QD PO Weight Decreased Other Mirtazapine SS ORAL 45 MG QD PO Sulpiride SS ORAL 400 MG QD PO Zopiclone SS ORAL 7.5 MG QD PO Date:01/05/05ISR Number: 4546841-1Report Type:Expedited (15-DaCompany Report #JP_041205477 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Hostility Study (Olanzapine) Health (Olanzapine) PS 10 MG DAY Professional Benzalin Other (Nitrazepam) C Maglax (Magnesium Oxide) C Senna Liquid Extract C Ensure Liquid C Date:01/05/05ISR Number: 4546842-3Report Type:Expedited (15-DaCompany Report #GBS041216213 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Foreign Olanzapine-Oral Initial or Prolonged Decreased Health (Olanzapine) PS 10 MG DAY White Blood Cell Count Professional Clozapine C Decreased Other Date:01/05/05ISR Number: 4546847-2Report Type:Expedited (15-DaCompany Report #FR_041205461 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Company Rivotril Representative (Clonazepam) C Other Seropram (Citalopram Hydrobromide) C Date:01/05/05ISR Number: 4546850-2Report Type:Expedited (15-DaCompany Report #AU_041208269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Drug Level Above Health (Olanzapine) PS Therapeutic Professional Intentional Self-Injury Other 24-Jun-2005 12:19 PM Page: 3333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/05ISR Number: 4546853-8Report Type:Expedited (15-DaCompany Report #EWC041241688 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Olanzapine-Oral Initial or Prolonged Pulmonary Embolism Health (Olanzapine) PS 2.5 MG DAY Pyrexia Professional Other Date:01/05/05ISR Number: 4546886-1Report Type:Expedited (15-DaCompany Report #JP_041205399 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Head Injury Foreign Zyprexa-Oral Road Traffic Accident Study (Olanzapine) PS 10 MG DAY Subdural Haematoma Health Cercine (Diazepam) C Professional Akineton (Biperiden Other Lactate) C Silece (Flunitrazepam Eg) C Adalat (Nifedipine Pa) C Lasix (Furosemide0 C Artist (Carvediolol) C Diovan (Valsartan0 C Bayaspirin (Acetylsalicylic Acid) C Warfarin C Isosorbide Dinitrate C Gaster (Famotidine) C Slow-K (Potassium Choride) C Magnesium Oxide C Date:01/05/05ISR Number: 4546887-3Report Type:Expedited (15-DaCompany Report #GBS041216068 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dry Mouth Foreign Olanzapine-Oral Incontinence Health (Olanzapine) PS 5 MG Muscle Spasms Professional Tegretol Musculoskeletal Stiffness Other (Carbamazepine Somnolence Rivopharm) C Carbimazole C Mefenamic Acid C Date:01/05/05ISR Number: 4546889-7Report Type:Expedited (15-DaCompany Report #GBS041115902 Age:60 YR Gender:Male I/FU:F Outcome PT Death Eating Disorder Hospitalization - Gastric Dilatation Initial or Prolonged Intestinal Dilatation Other Pneumonia Refusal Of Treatment By Patient Respiratory Distress Sepsis 24-Jun-2005 12:19 PM Page: 3334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tooth Abscess Vomiting Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 10 MG/2 DAY Professional Trazadone Company 9trazadone0 C Representative Tenormin (Atenolol Other Eg) C Lipostat (Pravastatin C Tritace (Ramipril) C Aspirin (Acetylsalicylic Acid) C Digoxin C Atrovent (Ipratropium Bromide) C Warfarin C Risperdal (Risperidone) C Date:01/05/05ISR Number: 4546899-XReport Type:Expedited (15-DaCompany Report #EWC040238032 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Olanzapine-Oral First Degree Health (Olanzapine) PS 20 MG/IN THE Blood Pressure Increased Professional EVENING Company Risperidone C Representative Other Date:01/05/05ISR Number: 4546908-8Report Type:Expedited (15-DaCompany Report #JP_041205387 Age:62 YR Gender:Female I/FU:I Outcome PT Life-Threatening Apnoea Other Blood Pressure Increased Cardiac Failure Acute Cardiac Ventricular Disorder Delusion Depressed Level Of Consciousness Diastolic Dysfunction Diet Refusal Dyspnoea Gaze Palsy Haematemesis Hyperhidrosis Hypertension Hyponatraemia Hypoxia Neuroleptic Malignant Syndrome Oxygen Saturation Decreased 24-Jun-2005 12:19 PM Page: 3335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Pulmonary Oedema Respiratory Depression Report Source Product Role Manufacturer Route Dose Duration Stridor Foreign Zyprexa-Oral White Blood Cell Count Health (Olanzapine) Decreased Professional (Olanzapine) PS 15 MG DAY Company Halomonth Representative (Haloperidol Other Decanoate) C Risperdal (Risperidone) C Gastromet (Cimetidine) C Akineton (Biperiden Lactate) C Aspara K (Aspartate Potassium) C Aminovact C Flunitrazepam C Metromin C Sennoside A+B C Date:01/05/05ISR Number: 4546910-6Report Type:Expedited (15-DaCompany Report #FR_041205458 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Depakote (Valproate Representative Semisodium) C Other Date:01/05/05ISR Number: 4547157-XReport Type:Expedited (15-DaCompany Report #US_0407104266 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Zyprexa-Dispresible Initial or Prolonged Anxiety Health (Olanzapine) Cerebral Atrophy Professional (Olanzapine) PS 30 MG/D Confusional State Cogentin Diabetes Mellitus (Benzatropine Insomnia Mesilate) C Libido Decreased Trileptal Migraine (Oxcarbazepine) C Social Avoidant Behaviour Effexor-Xr Somnolence (Venlafaxine Tooth Impacted Hydrochloride) C Weight Increased Aricept (Donepezil Hydrochloride) C Seroquel (Quetiapine Fumarate) C Provigil (Modafinil) C Trilafon (Perphenazine Enantate) C Glucophage (Metformin) C Depakote (Valproate 24-Jun-2005 12:19 PM Page: 3336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Levoxyl (Levothyroxine Sodium) C Zonegran (Zonisamide) C Zantac (Ranitidine Hydrochloride) C Celexa (Citalopram Hydrobromide) C Abilify (Aripiprazole) C Risperdal (Risperidone) C Vitamin E C Provigil (Modafinil) C Lisinopril (Lisinopril) C Date:01/05/05ISR Number: 4547162-3Report Type:Expedited (15-DaCompany Report #USA041184443 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Screen Positive Health Zyprexa-Oral Overdose Professional (Olanzapine) Therapeutic Agent (Olanzapine) PS 10 MG/2 DAY Toxicity Alupent (Orciprenaline Sulfate) C Imipramine C Neurontin (Gabapentin Pfizer) C Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Darvocet-N C Norvasc (Amlodipine) C Date:01/05/05ISR Number: 4547163-5Report Type:Expedited (15-DaCompany Report #US_0410106321 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Consumer Zyprexa (Olanzapine) PS ORAL Date:01/05/05ISR Number: 4547164-7Report Type:Expedited (15-DaCompany Report #USA040671193 Age:14 YR Gender:Male I/FU:F Outcome PT Other Chest Pain Feeling Cold Haematemesis Haemoptysis Nipple Pain Nipple Swelling Rhinitis Allergic 24-Jun-2005 12:19 PM Page: 3337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Strattera Health (Atomoxetine Professional Hydrochloride) PS ORAL 60 MG DAY Zyprexa (Olanzapine) SS ORAL 10 MG/1 AT BEDTIME ORAL Adderall C Concerta (Methylphenidate Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:01/05/05ISR Number: 4547165-9Report Type:Expedited (15-DaCompany Report #US_0410106320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa (Olanzapine) PS ORAL Date:01/05/05ISR Number: 4547300-2Report Type:Expedited (15-DaCompany Report #US_0412109449 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine Initial or Prolonged Akathisia Health (Olanzapine) PS ORAL Condition Aggravated Professional Bifeprunox SS Dyskinesia Lorazepam C Insomnia Psychotic Disorder Date:01/05/05ISR Number: 4547302-6Report Type:Expedited (15-DaCompany Report #US_0412109585 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Diabetic Ketoacidosis (Olanzapine) (Olanzapine) PS Geodon (Ziprasidone Hydrochloride) C Concerta (Methylphenidate Hydrochloride) C Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/05ISR Number: 4547303-8Report Type:Expedited (15-DaCompany Report #USA041286662 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Difficulty In Walking Consumer Zyprexa-Oral Hospitalization - (Olanzapine) Initial or Prolonged (Olanzapine) PS Date:01/05/05ISR Number: 4547311-7Report Type:Expedited (15-DaCompany Report #US_0412109582 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Inadequate Control (Olanzapine) PS Haematuria Pancreatitis Vomiting Weight Increased Date:01/05/05ISR Number: 4547313-0Report Type:Expedited (15-DaCompany Report #US_0408105111 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Consumer Zyprexa Hospitalization - Anxiety Health (Olanzapine) PS 5 MG Initial or Prolonged Aortic Aneurysm Professional Vioxx Other Arthritis (Rofecoxib) C Back Pain Risperidone C Blood Calcium Decreased Clonazepam C Bronchitis Thorazine Cardiomegaly (Chlorpromazine Chronic Obstructive Hydrochloride) C Airways Disease Lithium C Exacerbated Atrovent Comp C Confusional State Fosamax (Alendronate Cystitis Interstitial Sodium) C Diabetic Coma Nardil (Phenelzine) C Dizziness Prilosec (Omeprazole Eosinophil Count Ratiopharm) C Increased Ativan (Lorazepam) C Haemorrhage Enteric Aspirin Hyperglycaemia Increased Appetite Acetylsalicylic Micturition Urgency Acid) C Usa Nightmare Mavik (Trandolapril) C Paranoia Os-Cal C Pco2 Increased Humabid Protein Total Decreased (Guaifenesin L.A.) C Restlessness Neurontin Suprapubic Pain (Gabapentin Pfizer) C Tremor Vitamin C C Upper Respiratory Tract Zinc Sulfate C Infection Prednisone C Urge Incontinence Sucralfate C Urinary Retention Mucomyst Urinary Tract Infection (Acetylcysteine Vaginal Infection Sodium) C Visual Disturbance Levaquin Weight Increased (Levofloxacin) C 24-Jun-2005 12:19 PM Page: 3339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report General Lubricant Eye Drops (Genteal Lubricant Eye Drops) C Ciloxan (Ciprofloxacin Hydrochloride) C Voltaren (Diclofenac Potassium) C Darvocet-N C Simethicone C Mellaril (Thioridazine Hydrochloride) C Oxycontin (Oxycodone Hydrochloride) C Flovent (Fluticasone Propionate) C Advair C Caltate + D C Ultram (Tramadol Hydrochloride) C Combivent C Proventil (Salbutamol Sulfate) C Date:01/05/05ISR Number: 4548182-5Report Type:Direct Company Report #CTU 235745 E Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Olanzapine PS ORAL 10 MG PO QD 1 WK Initial or Prolonged Hyperhidrosis Benztropine C Mental Status Changes Haldol C Tremor Metoclopramide C Diphenhydramine C Date:01/06/05ISR Number: 4548365-4Report Type:Expedited (15-DaCompany Report #US_0412109501 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Amputation Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) (Olanzapine) PS Date:01/06/05ISR Number: 4549357-1Report Type:Expedited (15-DaCompany Report #FR_041205371 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Foreign Zyprexa-Dispersible Increased Health (Olanzapine) Completed Suicide Professional (Olanzapine) PS 20 MG DAY Condition Aggravated Other Effexor (Venlafaxine Delirium Hydrochloride) C Injury Asphyxiation Xanax (Alprazolam Dum) C Imovane (Zopiclone) C Lepticur (Tropatepine 24-Jun-2005 12:19 PM Page: 3340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:01/06/05ISR Number: 4549360-1Report Type:Expedited (15-DaCompany Report #FR_040704436 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 20 MG DAY Electrocardiogram Qt Company Tegretol Prolonged Representative (Carbamazepine) C Laboratory Test Other Seresta (Oxazepam) C Interference Zoloft (Sertraline Hydrochloride) C Imovane (Zopiclone) C Date:01/06/05ISR Number: 4549365-0Report Type:Expedited (15-DaCompany Report #AU_041108188 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Zyprexa-Oral Initial or Prolonged Cardiomyopathy Health (Olanzapine)(Olanzap Diabetes Mellitus Professional ine) PS 30 MG/1 DAY Dyspnoea Company Efexor (Venlafaxine) C Palpitations Representative Solian (Amisulpride) C Other Date:01/06/05ISR Number: 4549437-0Report Type:Expedited (15-DaCompany Report #USA041184091 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Symbax-Olanzapine 12 Completed Suicide Professional Mg/ Fluoxetine 25 Mg Cough Company (Olanzapine) PS Depressed Level Of Representative Zyprexa-Oral Consciousness (Olanzapine) SS 2.5 MG/1 DAY Hiccups Zoloft (Sertraline Hypersomnia Hydrochloride) C Increased Appetite Methadone C Overdose Treatment Noncompliance Vomiting Date:01/06/05ISR Number: 4549507-7Report Type:Expedited (15-DaCompany Report #DE_990601248 Age:68 YR Gender:Male I/FU:F Outcome PT Life-Threatening Activities Of Daily Hospitalization - Living Impaired Initial or Prolonged Aspiration Bacterial Infection Bronchial Infection Cerebral Atrophy Condition Aggravated Delusion Drug Resistance Facial Bones Fracture Fall 24-Jun-2005 12:19 PM Page: 3341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Granulocyte Count Decreased Haematotoxicity Report Source Product Role Manufacturer Route Dose Duration Hyperkinesia Foreign Zyprexa-Oral Neuroleptic Malignant Literature (Olanzapine) PS Syndrome Health Tremarit (Metixene Neutropenia Professional Hydrochloride) C Overdose Other Adalat Retard Paraesthesia (Nifedipine) C Paranoia Haldol (Haloperidol) C Parkinsonism Cephalexin C Pneumonia Psychotic Disorder Respiratory Failure Social Avoidant Behaviour Therapy Non-Responder Tremor White Blood Cell Count Decreased Wound Date:01/06/05ISR Number: 4549508-9Report Type:Expedited (15-DaCompany Report #DE_990601233 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Zyprexa(Olanzapine) PS 30 MG DAY Initial or Prolonged Neutropenia Literature Prescribed Overdose Health Professional Other Date:01/06/05ISR Number: 4549521-1Report Type:Expedited (15-DaCompany Report #EWC041242014 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Zyprexa-Oral Initial or Prolonged Drug Withdrawal Health (Olanzapine) PS 25 MG DAY Convulsions Professional Mirtazapine C Electrocardiogram Qt Company Corrected Interval Representative Prolonged Other Electrocardiogram St Segment Elevation Grand Mal Convulsion Mental Disorder Suicide Attempt Date:01/06/05ISR Number: 4551062-2Report Type:Expedited (15-DaCompany Report #CA_041207584 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Foreign Olanzapine-Oral Initial or Prolonged Idiopathic Health (Olanzapine) PS 7.5 MG DAY Thrombocytopenic Purpura Professional Penile Haemorrhage Other 24-Jun-2005 12:19 PM Page: 3342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/05ISR Number: 4547433-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0406391A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acquired Porphyria Wellbutrin PS Glaxosmithkline ORAL 42 DAY Aggression Tranquilizer SS Agitation Depakote SS Akathisia Zyprexa SS Alcohol Use Alcohol C Amnesia Arthralgia Asthenia Bipolar Disorder Body Temperature Fluctuation Convulsion Coordination Abnormal Crying Depression Depression Suicidal Disability Dizziness Dysarthria Dysphemia Dyspnoea Electric Shock Emotional Disorder Encephalopathy Facial Palsy Fatigue Feeling Abnormal Hair Metal Test Abnormal Headache Hyperaesthesia Hypersensitivity Hypoxia Immune System Disorder Injury Insomnia Intentional Self-Injury Mania Mastocytosis Metabolic Encephalopathy Multiple Chemical Sensitivity Muscle Spasms Myalgia Myoclonus Nervous System Disorder Neurotoxicity Nightmare Overdose Pain Of Skin Petit Mal Epilepsy Porphyria Schizoaffective Disorder Suicidal Ideation Suicide Attempt Throat Tightness Tremor Vestibular Disorder Vomiting 24-Jun-2005 12:19 PM Page: 3343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/05ISR Number: 4551450-4Report Type:Expedited (15-DaCompany Report #S04-FRA-08300-01 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Aotal(Acamprosate) PS Initial or Prolonged Drug Exposure During Health Aotal (Acamprosate) SS Pregnancy Professional Mepronizine SS ORAL 6 TABLET QD Measles Antibody Positive Other PO Toxoplasma Serology Zyprexa (Olanzapine) SS ORAL 10 MG QD PO Positive Lysanxia (Prazepam) SS ORAL 80 MG QD PO Effexor (Venlafaxine Hydrochloride) SS ORAL 400 MG QD PO Date:01/07/05ISR Number: 4551453-XReport Type:Expedited (15-DaCompany Report #S04-FRA-08300-02 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Aotal(Acamprosate) PS Initial or Prolonged Pregnancy Health Aotal (Acamprosate) SS Hypospadias Professional Mepronizine SS TRANSPLACENTAL 6 TABLET QD Renal Disorder Other TRANSPLACENTA L Zyprexa (Olanzapine) SS TRANSPLACENTAL 10 MG QD TRANSPLACENTA L Lysanxia (Prazepam) SS TRANSPLACENTAL 80 MG QD TRANSPLACENTA L Effexor (Venlafaxine Hydrochloride) SS ORAL 400 MG QD PO Date:01/10/05ISR Number: 4551529-7Report Type:Direct Company Report #CTU 236023 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Risperidone PS Galactorrhoea Olanazpine SS Date:01/11/05ISR Number: 4551469-3Report Type:Expedited (15-DaCompany Report #2004120941 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Xanax Tablet Initial or Prolonged Depressed Level Of Health (Alprazolam) PS ORAL ORAL Consciousness Professional Amitriptyline Hyponatraemia Hydrochloride (Amitriptyline Hydrochloride) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Paroxetine (Paroxetine) SS ORAL ORAL Donepezil Hydrochloride (Donepezil Hydrochloride) SS ORAL ORAL Prinzide (Hydrochlorothiazide , Lisinopril) C 24-Jun-2005 12:19 PM Page: 3344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantoprazole (Pantoprazole) C Date:01/11/05ISR Number: 4551700-4Report Type:Expedited (15-DaCompany Report #S04-USA-07843-01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Health Namenda (Memantine) PS Professional Zyprexa (Olanzapine) SS Company Representative Date:01/12/05ISR Number: 4550661-1Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0275099-00 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Depakote Tablets PS ORAL Hospitalization - Anorexia Depakote Tablets SS Initial or Prolonged Aphasia Lithium Carbonate SS ORAL Blood Creatinine Olanzapine SS ORAL Increased Olanzapine SS Blood Glucose Increased Confusional State Disturbance In Attention General Physical Health Deterioration Hypernatraemia Mutism Nephrogenic Diabetes Insipidus Polydipsia Polyuria Pyrexia Tremor Urinary Incontinence Date:01/12/05ISR Number: 4551642-4Report Type:Expedited (15-DaCompany Report #US_0408105111 Age:79 YR Gender:Female I/FU:F Outcome PT Death Anaemia Hospitalization - Aortic Aneurysm Initial or Prolonged Arthralgia Other Arthritis Atrioventricular Block First Degree Back Pain Bipolar Disorder Blood Calcium Decreased Bowel Sounds Abnormal Bronchitis Cardiomegaly Cellulitis Chronic Obstructive Airways Disease Exacerbated Coma Condition Aggravated 24-Jun-2005 12:19 PM Page: 3345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cough Cystitis Interstitial Decreased Appetite Report Source Product Role Manufacturer Route Dose Duration Delirium Consumer Zyprexa-Oral Diarrhoea Health (Olanzapine) Dissociation Professional (Olanzapine) PS 5 MG Dizziness Vioxx (Rofecoxib) C Drug Ineffective Risperidone C Drug Interaction Clonazepam C Electrocardiogram St Thorazine Segment Abnormal (Chlorpromazine Encephalopathy Hydrochloride) C Eosinophil Count Lithium C Increased Atrovent Comp C Haemorrhage Fosamax (Alendronate Hallucination Sodium) C Hyperglycaemia Nardil (Phenelzine) C Hyperhidrosis Prilosec (Omeprazole Hypertension Ratiopharm) C Hypotension Ativan (Lorazepam) C Increased Appetite Enteric Aspirin C Inflammation Mavik (Trandolapril) C Major Depression Os-Cal C Medication Error Humabid (Guaifenesin Nightmare L.A.) C Overdose Neurontin Pancreatitis Haemorrhagic (Gabapentin Pfizer) C Paranoia Vitamin C C Protein Total Decreased Zinc Sulfate C Restlessness Prednisone C Suicidal Ideation Sucralfate C Tremor Mucomyst Upper Respiratory Tract (Acetylcysteine Infection Sodium) C Urinary Tract Infection Levaquin Uterine Leiomyoma (Levofloxacin) C Vaginal Infection Genteal Lubricant Visual Disturbance Eye Drops (Genteal Weight Fluctuation Lubricant Eye Drops) C Giloxan (Ciprovloxacin Hydrochloride) C Voltaren (Diclofenac Potassium) C Darvocet-N C Simethicone C Mellaril (Thioridazine Hydrochloride) C Oxycontin (Oxycodoe Hydrochloride) C Flovent (Fluticasone Propionate) C Advair C Caltrate + D C Ultram (Tramadol Hydrochloride) C Combivent C Proventil (Salbutamol Sulfate) C Methylprednisolone C 24-Jun-2005 12:19 PM Page: 3346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Peri-Colace C Lasix (Furosemide) C Ditropan Xl (Oxybutynin Hydrochloride) C Aricept (Donepezil Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Remeron (Mirtazapine Orifarm) C Macrobid (Nitrofurantoin) C Elmiron (Pentosan Polysulfate Sodium) C Senokot (Senna Alexandrina) C Date:01/12/05ISR Number: 4551976-3Report Type:Expedited (15-DaCompany Report #US_0405103315 Age:39 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Adenoma Benign Other Anxiety Arthralgia Balance Disorder Chest Pain Contusion Costochondritis Depression Diabetes Mellitus Difficulty In Walking Dilatation Atrial Disturbance In Attention Drug Abuser Ear Pain Ejection Fraction Decreased Fatigue Gait Disturbance Gingival Pain Glycosylated Haemoglobin Increased Haemorrhage Hallucination Headache Hyperlipidaemia Hypoaesthesia Irritability Local Swelling Mass Mitral Valve Incompetence Neck Pain Nervousness Oedema Peripheral Oral Intake Reduced Pain In Jaw Suicidal Ideation Tremor 24-Jun-2005 12:19 PM Page: 3347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tricuspid Valve Incompetence Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 12.5 MG/1 AT BEDTIME Zoloft (Sertraline Hydrochloride) C Glucophage Xr (Metforin Hydrochloride) C Zocor (Simvastatin Ratiopharm) C Lipitor (Atorvastatin Calcium) C Verapamil C Aspirin (Acetylsalicylic Acid) C Multivitamin C Haldol (Halperidol Decanoate) C Paxil (Paroxetine Hydrochloride) C Advicor C Colace (Docusate Sodium) C Cozaar (Losartan Potassium) C Allegra (Fexofenadine Hydrochloride) C Lorcet Plus C Tylenol With Codeine C Darvocet-N 100 C Ultram (Tramadol Hydrochloride) C Risperdal (Risperidone) C Percocet C Vicodin C Nasocort (Budesonide) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Tranxene (Clorazepate Dipotassium) C Surbex-T C Mylanta C Milk Of Magnesia C Aripiprazole C Clorazepate Dipotassium C Thiamine Hydrochloride C Benadryl C 24-Jun-2005 12:19 PM Page: 3348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/05ISR Number: 4553106-0Report Type:Expedited (15-DaCompany Report #US_0412109609 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Hypertension (Olanzapine) Myocardial Infarction (Olanzapine) PS Weight Increased Date:01/12/05ISR Number: 4553110-2Report Type:Expedited (15-DaCompany Report #US_0412109596 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Hypertension (Olanzapine) PS Myocardial Infarction Weight Increased Date:01/12/05ISR Number: 4553138-2Report Type:Expedited (15-DaCompany Report #US_0501109708 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Ketoacidosis (Olanzapine) (Olanzapine) PS Date:01/12/05ISR Number: 4553263-6Report Type:Expedited (15-DaCompany Report #USA041286385 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa-Oral Life-Threatening Diabetic Coma Professional (Olanzapine) Hospitalization - Food Craving Company (Olanzapine) PS 20 MG Initial or Prolonged Representative Other Date:01/12/05ISR Number: 4553333-2Report Type:Expedited (15-DaCompany Report #US_0405103329 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Back Pain Initial or Prolonged Chest Pain Condition Aggravated Coronary Artery Disease Dental Caries Diabetes Mellitus Diplopia Dizziness Drug Ineffective Dyspnoea Fall Hypertension Hypotension Impaired Healing Joint Dislocation Radius Fracture Tinnitus 24-Jun-2005 12:19 PM Page: 3349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tooth Abscess Tooth Disorder Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG /1 AT BEDTIME Sinequan (Doxepin Hydrochloride) C Remeron (Mirtazapine Orifarm) C Paxil(Paroxetine Hydrochloride) C Zoloft(Sertraline Hydrochloride) C Glipizide C Novolin Nph(Insulin Human Injection, Isophane) C Glucophage(Metformin ) C Multivitamin C Nitrostat(Glyceryl Trinitrate) C Vistaril(Hydroxyzine Embonate) C Timoptic(Timolol Maleate) C Zocor(Simvastatin Ratiopharm) C Cromolyn Sodium C Buspar(Buspirone Hydrochloride) C Coral Calcium C Lisinopril(Lisinopri l) C Zetia(Ezetimibe) C Motrin (Ibuprofen) C Vicodin C Aspirin(Acetylsalicy lic Acid) C Xalatan C Hydrochlorothiazide C Date:01/12/05ISR Number: 4553352-6Report Type:Expedited (15-DaCompany Report #JP_041205539 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa-Oral Long Qt Syndrome Study (Olanzapine) Ventricular Extrasystoles Health (Olanzapine) PS 5 MG/1 DAY Professional Tasmolin (Biperiden) C Other 24-Jun-2005 12:19 PM Page: 3350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/05ISR Number: 4553360-5Report Type:Expedited (15-DaCompany Report #FR_040704452 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa-Oral Vomiting Health (Olanzapine) Professional (Olanzapine) PS Other Depamide (Valpromide) C Date:01/12/05ISR Number: 4553365-4Report Type:Expedited (15-DaCompany Report #EWC041242055 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Olanzapine-Oral Sudden Death Health (Olanzapine) PS 10 MG DAY Professional Diazepam C Other Date:01/12/05ISR Number: 4553367-8Report Type:Expedited (15-DaCompany Report #FR_041205498 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa-Oral Blood Testosterone Health (Olanzapine) Increased Professional (Olanzapine) PS 10 MG DAY Full Blood Count Abnormal Company Representative Other Date:01/12/05ISR Number: 4553421-0Report Type:Expedited (15-DaCompany Report #EWC041241993 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Areflexia Foreign Olanzapine-Long-Acti Initial or Prolonged Coma Study ng Im (Depot) PS OTHER 405 MG OTHER Dizziness Health Extensor Plantar Response Professional Heart Rate Increased Other Miosis Movement Disorder Sedation Somnolence Speech Disorder Date:01/12/05ISR Number: 4553440-4Report Type:Expedited (15-DaCompany Report #CA_041007323 Age:97 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abasia Initial or Prolonged Confusional State Coordination Abnormal Dementia Depression Drug Interaction Drug Intolerance Incoherent Infection 24-Jun-2005 12:19 PM Page: 3351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Somnolence Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Foreign Zyprexa Weight Decreased Consumer Health (Olanzapine) PS ORAL 7.5 MG AT Professional BEDTIME Other Haldol (Haloperidol) C Serax (Oxazepam) C Vasotec (Enalapril Maleate) C Aspirin (Acetylsalicylic Acid) C Potassium Chloride C Furosemide (Furosemide) C Digoxin C Date:01/12/05ISR Number: 4553442-8Report Type:Expedited (15-DaCompany Report #EWC041241773 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa Other Drug Abuser Health Professional (Olanzapine) PS ORAL Other Date:01/12/05ISR Number: 4553443-XReport Type:Expedited (15-DaCompany Report #FR_041205502 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Copper Increased Foreign Zyprexa Initial or Prolonged Cholestasis Health Headache Professional (Olanzapine) PS ORAL Hepatitis Other Prozac Hepatitis C (Fluoxetine Hepatocellular Damage Hydrochloride) SS ORAL 20 MG/1 DAY Influenza Like Illness Depakine Myalgia Nausea (Valproate Sodium) C Thrombocytopenia Methadone C Vomiting Cocaine Hydrochloride C Subutex (Buprenorphine Hydrochloride) C Imovane (Zopiclone) C Hepatitis B Vaccine C 24-Jun-2005 12:19 PM Page: 3352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/05ISR Number: 4553444-1Report Type:Expedited (15-DaCompany Report #FR_041205461 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Zyprexa-Oral Hospitalization - Chest Pain Health (Olanzapine) Initial or Prolonged Myocardial Infarction Professional (Olanzapine) PS 10MG/1 DAY Phlebitis Superficial Company Rivotril Representative (Clonazepam) C Other Seropram (Citalopram Hydrobromide) C Date:01/12/05ISR Number: 4553446-5Report Type:Expedited (15-DaCompany Report #JP_041004698 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Hypersensitivity Foreign Zyprexa Hospitalization - Photosensitivity Reaction Literature Initial or Prolonged Health (Olanzapine) PS ORAL 10 MG DAY Professional Depakene (Valproate Company Sodium) C Representative Limas (Lithium Other Carbonate) C Furosemide (Furosemide) C Magnesium Oxide C Date:01/12/05ISR Number: 4553447-7Report Type:Expedited (15-DaCompany Report #JP_030901754 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa Hospitalization - Increased Literature (Olanzapine) PS ORAL 10 MG DAY Initial or Prolonged Aspartate Health Amoban Aminotransferase Professional (Zopiclone) C Increased Company Cercine Blood Creatine Representative (Diazepam) C Phosphokinase Increased Other Cefazolin Sodium C Blood Lactate Cravit Dehydrogenase Increased (Levofloxacin) C Dialysis Perdipin La Pulmonary Oedema (Nicardipine Pyrexia Hydrochloride) C Respiratory Failure Heparin C Rhabdomyolysis Lasix (Furosemide) C Mannitol C Epogin (Epoetin Beta) C Date:01/12/05ISR Number: 4553456-8Report Type:Expedited (15-DaCompany Report #FR_041205458 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Sedation Health Im (Olanzapine) PS 20 MG DAY Professional Tercian Company (Cyamemazine) C Representative Loxapac (Loxapine Other Succinate) C 24-Jun-2005 12:19 PM Page: 3353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/05ISR Number: 4553458-1Report Type:Expedited (15-DaCompany Report #JP_030901726 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Zyprexa-Oral Initial or Prolonged Electrocardiogram Q Wave Literature (Olanzapine) Disability Abnormal Health (Olanzapine) PS 10 MG AT Hypotonia Professional BEDTIME Hypoxia Company Serenace Radial Nerve Palsy Representative (Haloperidol) C Respiratory Failure Other Depas (Etizolam) C Sleep Apnoea Syndrome Artane (Trihehyphenidyl Hydrochloride) C Contomin (Chlorpromazine Hydrochloride) C Pursennide (Senna Leaf) C Date:01/12/05ISR Number: 4553474-XReport Type:Expedited (15-DaCompany Report #GBS041115879 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Foreign Olanzapine-Oral Pregnancy Health (Olanzapine) PS 10 MG AT Foetal Distress Syndrome Professional BEDTIME Other Lithium Carbonate C Iron C Date:01/12/05ISR Number: 4553544-6Report Type:Expedited (15-DaCompany Report #JP_050105551 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Foreign Zyprexa-Oral Initial or Prolonged Living Impaired Literature (Olanzapine) Anxiety Health (Olanzapine) PS 15 MG DAY 7 MON Apathy Professional Risperidone C Autism Other Sulpiride C Decreased Activity Depression Phobia Date:01/12/05ISR Number: 4553550-1Report Type:Expedited (15-DaCompany Report #DE_041114618 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Polyneuropathy Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Other Date:01/13/05ISR Number: 4551031-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12577987 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Desyrel Tabs PS Apothecon Physical Assault Zoloft SS 24-Jun-2005 12:19 PM Page: 3354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa SS Date:01/13/05ISR Number: 4553269-7Report Type:Expedited (15-DaCompany Report #A044-002-005325 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Aricept Initial or Prolonged Depressed Level Of Health (Donepezil Consciousness Professional Hydrochloride) PS ORAL 1 IN 1 D, Hyponatraemia ORAL Laroxyl (Amitriptyline Hydrochloride) SS ORAL ORAL Xanax (Alprazolam) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Deroxat (Paroxetine Hydrochloride) SS ORAL ORAL Zestoretic (Prinzide) C Inipomp (Pantoprazole) C Date:01/13/05ISR Number: 4553861-XReport Type:Direct Company Report #CTU 236351 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Zyprexa PS Dehydration Fibromyalgia Nervous System Disorder Pericardial Effusion Pleural Effusion Date:01/14/05ISR Number: 4556420-8Report Type:Expedited (15-DaCompany Report #USA041286864 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Increased Consumer Zyprexa-Oral Initial or Prolonged Company (Olanzapine) Other Representative (Olanzapine) PS Risperdal (Risperidone) C Zoloft (Sertraline Hydrochloride) C Date:01/14/05ISR Number: 4556604-9Report Type:Expedited (15-DaCompany Report #HQWYE726612OCT04 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Increased Health Efexor Xr Initial or Prolonged Oedema Peripheral Professional (Venlafaxine Other Pain In Extremity Hydrochloride, Capsule, Extended 24-Jun-2005 12:19 PM Page: 3355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Release) PS ORAL SEE IMAGE 26 DAY Efexor (Venlafaxine Hydrochloride, Tablet) SS ORAL 37.5 MG 1X PER 1 DAY 4 DAY Zyprexa (Olanzapine) SS ORAL SEE IMAGE 32 DAY Valium (Diazepam) C Olfen (Diclofenac Sodium) C Date:01/18/05ISR Number: 4555142-7Report Type:Expedited (15-DaCompany Report #US-MERCK-0501USA01941 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Prerenal Failure Health Hydrodiuril PS Merck & Co., Inc UNKNOWN Initial or Prolonged Beta Haemolytic Professional Benztropine Mesylate SS UNKNOWN Streptococcal Infection Olanzapine SS UNKNOWN Bipolar Disorder Valproic Acid SS UNKNOWN Blood Amylase Increased Coma Depressed Mood Diabetes Mellitus Non-Insulin-Dependent Encephalopathy Headache Heart Rate Increased Hyperglycaemic Hyperosmolar Nonketotic Syndrome Hyperhidrosis Lipase Increased Miosis Pancreatitis Sepsis Sputum Culture Positive Therapy Non-Responder Vomiting Date:01/19/05ISR Number: 4557359-4Report Type:Direct Company Report #CTU 237200 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Zyprexa 15 Mg. Intervention to Insulin-Dependent Eli Lilly PS Eli Lilly ORAL 15 MG QHS Prevent Permanent ORAL Impairment/Damage Insulin Control C Date:01/19/05ISR Number: 4558469-8Report Type:Expedited (15-DaCompany Report #US_0409105908 Age:11 YR Gender: I/FU:I Outcome PT Hospitalization - Anorexia Initial or Prolonged Blood Chloride Decreased Blood Cholesterol Increased Blood Potassium Increased Blood Sodium Decreased Chest Pain Diabetes Mellitus 24-Jun-2005 12:19 PM Page: 3356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Ketoacidosis Glycosylated Haemoglobin Increased Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Zyprexa-Oral Weight Decreased (Olanzapine) (Olanzapine) PS 5 MG Srattera (Atomoxetine Hydrochloride) SS 25 MG Patanol (Olopatadine Hydrochloride) C Remeron (Mirtazapine Orifarm) C Zithromax (Azithromycin) C Dextroamphetamine (Dexamfetamine) C Methylphenidate C Concerta (Methylphenidate Hydrochloride) C Amoxicillin C Ritalin La (Methylphenidate Hydrochloride) C Adderall Xr C Quindal Hd Plus C Date:01/19/05ISR Number: 4558474-1Report Type:Expedited (15-DaCompany Report #US_0501109885 Age:42 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abdominal Pain Lower Other Abnormal Faeces Arthralgia Asthenia Asthma Back Pain Blood Glucose Decreased Blood Pressure Systolic Increased Bronchitis Buttock Pain Chest Pain Cholecystitis Cholelithiasis Condition Aggravated Cyst Decreased Appetite Diabetes Mellitus Diarrhoea Dizziness Dyspepsia Faeces Discoloured Fall Fatigue Feeling Abnormal Food Poisoning Headache 24-Jun-2005 12:19 PM Page: 3357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Steatosis Hyperhidrosis Hypotension Report Source Product Role Manufacturer Route Dose Duration Lacrimation Increased Consumer Zyprexa-Oral Loss Of Consciousness Health (Olanzapine) Muscle Strain Professional (Olanzapine) PS 15 MG DAY Nausea Combivent C Pain In Extremity Prinivil Painful Defaecation (Lisinopril) C Pancreatitis Prilosec (Omeprazole Proctalgia Ratiopharm) C Rectal Haemorrhage Ativan (Lorazepam) C Rhinitis Allergic Paxil Cr (Paraxetine Thrombocythaemia Hydrochloride) C Treatment Noncompliance Prednisone C Tunnel Vision Theo-Dur Vertigo (Theophylline) C Vision Blurred Protonix Vomiting (Pantoprazole) C White Blood Cell Count Theophylline Increased (Theophylline) C Desipramine C Flovent (Fluticasone Propionate) C Beconase (Beclometasone Dipropionate) C Fluocinonide C Tolazamide C Chlortrimeton (Chlorpheniramine Maleate) C Ceftin (Cefuroxime Axetil) C Unasyn (Sultamicillin Tosilate) C Phenergan (Promethazine Hydrochloride) C Norlutate (Norethisterone Acetate) C Temazepam C Date:01/19/05ISR Number: 4558492-3Report Type:Expedited (15-DaCompany Report #US_0501109967 Age:33 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anger Initial or Prolonged Back Pain Other Blood Alkaline Phosphatase Increased Blood Ketone Body Increased Blood Pressure Systolic Increased Blood Urea Increased Chest Pain Dehydration 24-Jun-2005 12:19 PM Page: 3358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delusion Diabetes Mellitus Non-Insulin-Dependent Report Source Product Role Manufacturer Route Dose Duration Ear Pain Consumer Zyprexa-Oral Electrolyte Imbalance Health (Olanzapine) Foreign Body Trauma Professional (Olanzapine) PS Hallucinations, Mixed Trazodone C Herpes Simplex Avandia Hyperosmolar State (Rosiglitazone Hypokalaemia Maleate) C Hyponatraemia Risperdal Lipase Increased (Risperidone) C Musculoskeletal Pain Protonix Nausea (Pantoprazole) C Neuropathy Peripheral Milk Of Magnesia C Pain In Extremity Pancreatitis Penis Disorder Pharyngolaryngeal Pain Pyrexia Respiratory Rate Increased Skin Lesion Suicidal Ideation Tachycardia Treatment Noncompliance Vomiting Xanthopsia Date:01/19/05ISR Number: 4558692-2Report Type:Expedited (15-DaCompany Report #US_0501109957 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa-Oral Initial or Prolonged Condition Aggravated (Olanzapine) Other Depression (Olanzapine) PS Liver Disorder Neuropathy Pancreatitis Panic Attack Date:01/19/05ISR Number: 4559105-7Report Type:Expedited (15-DaCompany Report #K200500036 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Sonata Initial or Prolonged Intentional Misuse Health (Zaleplon) PS ORAL 70 MG, (14 Mydriasis Professional CAPSULES) Other Cipramil (Citalopram Hydrochloride) SS ORAL 400 MG, (20 TABLETS), SINGLE, ORAL Tafil (Alprazolam) SS ORAL 20 MG, (20 TABLETS) Zyprexa (Olanzapine) SS ORAL 50 MG, (20 TABLETS) 24-Jun-2005 12:19 PM Page: 3359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/05ISR Number: 4559529-8Report Type:Expedited (15-DaCompany Report #EWC050142117 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Foreign Zyprexa Oral Pituitary Cyst Health (Olanzapine)(Olanzap Professional ine) PS Other Date:01/20/05ISR Number: 4557056-5Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0406391A Age: Gender:Male I/FU:F Outcome PT Other Acquired Porphyria Aggression Agitation Akathisia Alcohol Use Amnesia Arthralgia Asthenia Bipolar Disorder Body Temperature Fluctuation Convulsion Coordination Abnormal Crying Depression Depression Suicidal Disability Dizziness Dysarthria Dysphemia Dyspnoea Electric Shock Emotional Disorder Encephalopathy Facial Palsy Fatigue Feeling Abnormal Hair Metal Test Abnormal Head Injury Headache Hyperaesthesia Hypersensitivity Hypoxia Immune System Disorder Injury Insomnia Intentional Self-Injury Mania Mastocytosis Medication Error Metabolic Encephalopathy Muscle Spasms Myalgia Myoclonus Nervous System Disorder Nightmare Overdose Pain Of Skin 24-Jun-2005 12:19 PM Page: 3360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Petit Mal Epilepsy Psychotic Disorder Schizoaffective Disorder Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Wellbutrin PS Glaxosmithkline ORAL 42 DAY Suicide Attempt Tranquilizer SS Throat Tightness Depakote SS Tremor Zyprexa SS Vestibular Disorder Alcohol C Vomiting Date:01/20/05ISR Number: 4557060-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0538024A Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Wellbutrin PS Glaxosmithkline ORAL 150MG Per day Initial or Prolonged Incontinence Symbyax SS 30 DAY Loss Of Consciousness Sexual Dysfunction Date:01/21/05ISR Number: 4558642-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500945 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Risperidone PS UNKNOWN 308 DAY Initial or Prolonged Gastrointestinal Necrosis Olanzapine SS UNKNOWN 308 DAY Pneumonia Quetiapine SS UNKNOWN 308 DAY Trazodone C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Feso4 C Carbamazepine C OROPHARINGEAL Date:01/21/05ISR Number: 4558978-1Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0286181-00 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Valproate Sodium PS ORAL Restlessness Valproate Sodium SS Dose Somnolence decreased Weight Increased Olanzapine SS ORAL 3 MON Diazepam C ORAL 1 MON Date:01/21/05ISR Number: 4559143-4Report Type:Direct Company Report #CTU 237615 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Interaction Warfarin PS International Normalised Digoxin SS Ratio Fluctuation Simvastatin SS Olanzapine SS Sertraline SS 24-Jun-2005 12:19 PM Page: 3361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Senna SS Diazepam SS Lactulose Mirtazepine SS Thyroxine SS Date:01/21/05ISR Number: 4560745-XReport Type:Expedited (15-DaCompany Report #CA_050107599 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Zyprexa-Oral Other Pneumonia Consumer (Olanzapine) Weight Increased Other (Olanzapine) PS 2 MON Epival (Valproate Semisodium) C Date:01/21/05ISR Number: 4561164-2Report Type:Expedited (15-DaCompany Report #US_0409106184 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) Other Breast Pain Professional (Olanzapine) PS 20 MG AT Buttock Pain BEDTIME Cellulitis Risperidone C Diabetes Mellitus Venlafaxine C Dizziness Divalproex Sodium C Gastrointestinal Disorder Luvox (Fluvoxamine Gout Maleate) C Musculoskeletal Pain Paxil (Paroxetine Staphylococcal Infection Hydrochloride) C Subcutaneous Abscess Depakote (Valproate Semisodium) C Trazadone (Trazodone) C Celexa (Citalopram Hydrobromide) C Effexor (Venlafaxine Hydrochloride) C Hydrochlorothiazide C Vistaril (Hydroxyzine Embonate) C Date:01/21/05ISR Number: 4561443-9Report Type:Expedited (15-DaCompany Report #USA041286314 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa-Oral Petechiae Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Flaxseed C Percocet C 24-Jun-2005 12:19 PM Page: 3362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4561482-8Report Type:Expedited (15-DaCompany Report #US_0501109908 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:01/21/05ISR Number: 4561484-1Report Type:Expedited (15-DaCompany Report #US_0501109971 Age:39 YR Gender:Male I/FU:I Outcome PT Death Abnormal Behaviour Other Abnormal Dreams Acute Prerenal Failure Affect Lability Anger Antisocial Behaviour Anxiety Asthenia Atelectasis Blood Creatine Phosphokinase Increased Blood Glucose Increased Bradyphrenia Coma Decreased Appetite Dehydration Delusion Depression Diabetic Hyperosmolar Coma Disturbance In Attention Dry Mouth Electrolyte Imbalance Encephalopathy Fatigue General Physical Health Deterioration Grandiosity Hepatic Enzyme Increased Hepatic Steatosis Homicidal Ideation Hypercalcaemia Hyperglycaemia Hyperhidrosis Hypernatraemia Hypersomnia Hypomania Hypotension Hypovolaemia Incoherent Insomnia Irritability Lethargy Liver Function Test Abnormal Lung Infiltration Malaise Mania Meningitis Bacterial 24-Jun-2005 12:19 PM Page: 3363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Status Changes Negativism Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Consumer Zyprexa-Oral Nightmare Health (Olanzapine) Obesity Professional (Olanzapine) PS 20 MG Paranoia Prozac-Oral Psychotic Disorder (Fluoxetine) Pyrexia Fluoxetine Renal Failure Acute Hydrochloride) SS 20 MG/1 DAY Restlessness Effexor (Venlafaxine Rhabdomyolysis Hydrochloride) C Scar Lithium C Self-Injurious Ideation Seroquel (Quetiapine Social Avoidant Behaviour Fumarate) C Suicidal Ideation Risperidone C Thrombocytopenia Amantadine C Treatment Noncompliance Topamax (Topiramate) C Urinary Incontinence Zoloft (Sertraline Vision Blurred Hydrochloride) C Weight Increased Ritalin (Methylphenidate Hydrochloride) C Neurontin (Gabapentin Pfizer) C Thorazine (Chlorpromazine Hydrochloride) C Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Ambien (Zolpidem Tartrate) C Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Oxazepam C Date:01/21/05ISR Number: 4561486-5Report Type:Expedited (15-DaCompany Report #US_0501109899 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemangioma Consumer Zyprexa-Oral Other Pituitary Tumour Benign (Olanzapine) (Olanzapine) PS Date:01/21/05ISR Number: 4561540-8Report Type:Expedited (15-DaCompany Report #USA041286531 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Zyprexa-Oral Initial or Prolonged Hypotension Professional (Olanzapine) Other Loss Of Consciousness (Olanzapine) PS Tachycardia 24-Jun-2005 12:19 PM Page: 3364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4561542-1Report Type:Expedited (15-DaCompany Report #US_0501109945 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Akathisia Health (Olanzapine) Other Asthma Professional (Olanzapine) PS 5 MG AT Blood Calcium Decreased BEDTME Chronic Obstructive Sinequan (Doxepin Airways Disease Hydrochloride) C Exacerbated Serzone (Nefazodone Coronary Artery Disease Hydrochloride) C Cushingoid Lortab C Diabetes Mellitus Xanax (Alprazolam Inadequate Control Dum) C Diarrhoea Thorazine Discomfort (Chlorpromazine Dissociative Disorder Hydrochloride) C Dry Skin Eating Disorder Emotional Distress Emphysema Fatigue Feeling Abnormal Hypercholesterolaemia Hyperglycaemia Hypoaesthesia Hypoglycaemia Hypoxia Lung Disorder Major Depression Muscle Spasms Myocardial Infarction Nausea Night Sweats Nocturia Oedema Peripheral Oral Candidiasis Overdose Pain Paraesthesia Restlessness Rhinitis Allergic Suicidal Ideation Temperature Intolerance Thinking Abnormal Upper Respiratory Tract Infection Vision Blurred Weight Increased Wheezing Date:01/21/05ISR Number: 4561548-2Report Type:Expedited (15-DaCompany Report #US_0411107788 Age: Gender:Male I/FU:F Outcome PT Death Anorexia Life-Threatening Blood Glucose Increased Body Temperature Increased Circulatory Collapse 24-Jun-2005 12:19 PM Page: 3365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Constipation Energy Increased Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa-Oral Hepatic Steatosis Health (Olanzapine) Hyperglycaemia Professional (Olanzapine) PS 10 MG/2 DAY Insomnia Cogentin Moaning (Benzatropine Pollakiuria Besilate) C Treatment Noncompliance Haldol (Haloperidol Weight Increased Decaonate) C Detrol (Tolterodine) C Ditropan Xl (Oxybutynin Hydrochloride) C Date:01/21/05ISR Number: 4562174-1Report Type:Expedited (15-DaCompany Report #US_0407104490 Age:44 YR Gender:Female I/FU:F Outcome PT Other Abdominal Pain Upper Amnesia Anxiety Blood Cholesterol Abnormal Blood Creatine Phosphokinase Increased Blood Oestrogen Decreased Blood Pressure Increased Blood Pressure Systolic Increased Blood Triglycerides Increased Blood Urea Decreased Body Temperature Increased Chest Discomfort Chest Pain Cholelithiasis Confusional State Constipation Depression Diabetes Mellitus Diarrhoea Dizziness Eating Disorder Fatigue Food Craving Generalised Anxiety Disorder Hallucination, Auditory Headache Hormone Level Abnormal Hyperventilation Hypoaesthesia Increased Appetite Injection Site Haemorrhage Malaise Mediastinal Disorder 24-Jun-2005 12:19 PM Page: 3366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Menorrhagia Mental Disorder Monocyte Count Increased Report Source Product Role Manufacturer Route Dose Duration Mood Altered Consumer Zyprexa Neuropathy Health Obesity Professional (Olanzapine) PS ORAL 15 MG Osteoporosis Keflex Ovarian Cyst (Cefalexin Pain Monohydrate) C Palpitations Multivitamins Nos Pancreatitis Panic Attack Paraesthesia (Multivitamins Nos) C Peptic Ulcer Geodon Premenstrual Syndrome (Ziprasidone Pruritus Hydrochloride) C Refusal Of Treatment By Quetiapine C Patient Risperidone C Sexual Activity Increased Haloperidol C Somnolence Navane (Tiotixene) C Tachycardia Depakote (Valproate Treatment Noncompliance Semisodium) C Umbilical Hernia Bupropion C Urinary Incontinence Celexa (Citalopram Urticaria Hydrobromide) C Vaginal Haemorrhage Symbyax C Weight Increased Paxil (Paroxetine Hydrochloride) C Venlafaxine C Trazadone (Trazodone) C Luvox (Fluvoxamine Maleate) C Insulin C Oral Contraceptive Nos C Lorazepam C Alprazolam C Artane (Trihexyphenidyl Hydrochloride) C Depo Provera (Medroxyprogesterone Acetate) C Date:01/21/05ISR Number: 4562175-3Report Type:Expedited (15-DaCompany Report #US_030695122 Age:25 YR Gender:Female I/FU:F Outcome PT Other Agitation Akinesia Coma Confusional State Delusion Diabetes Mellitus Non-Insulin-Dependent Encephalopathy Eye Pain Hyperkalaemia Hyperlipidaemia 24-Jun-2005 12:19 PM Page: 3367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypernatraemia Hypertension Hypovolaemia Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Zyprexa-Oral Leukocytosis Health (Olanzapine) Obesity Professional (Olanzapine) PS 20 MG/AT Paranoia BEDTIME Protein Total Increased Haldol (Haloperidol) C Renal Failure Acute Depakote (Valproate Restlessness Semisodium) C Rhabdomyolysis Seroquel (Quetiapine Sinus Tachycardia Fumarate) C Social Avoidant Behaviour Lorazepam C Treatment Noncompliance Benztropine C Vomiting Nicotine Dermal Patch (Nicotine Resin) C Temazepam C Date:01/21/05ISR Number: 4562184-4Report Type:Expedited (15-DaCompany Report #USA041287013 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa Professional Company Representative (Olanzapine) PS ORAL Date:01/21/05ISR Number: 4562186-8Report Type:Expedited (15-DaCompany Report #US_0412109449 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine-Oral Initial or Prolonged Akathisia Health (Olanzapine) PS Condition Aggravated Professional Bifeprunox SS Dyskinesia Lorazepam C Insomnia Irritability Psychotic Disorder Date:01/21/05ISR Number: 4562188-1Report Type:Expedited (15-DaCompany Report #US_0406103675 Age:49 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acne Initial or Prolonged Alanine Aminotransferase Other Increased Ammonia Increased Anger Anxiety Apathy Aspartate Aminotransferase Increased Blood Albumin Decreased Blood Glucose Fluctuation Blood Glucose Increased Blood Thyroid Stimulating 24-Jun-2005 12:19 PM Page: 3368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hormone Decreased Contusion Cystitis Klebsiella Depression Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa Non-Insulin-Dependent Health Disturbance In Attention Professional Diverticulitis (Olanzapine) PS ORAL 45 MG AT Dizziness BEDTIME Drug Abuser Abilify Eye Disorder Fall (Aripiprazole) C Fatigue Wellbutrin Sr Fear Flat Affect (Bupropion Formication Hydrochloride) C Gamma-Glutamyltransferase Paxil (Paroxetine Increased Hydrochloride) C Hallucination, Auditory Antabuse Headache (Disulfiram) C Hypercholesterolaemia Spironolactone Hyperphagia (Spironolactone) C Hypotension Lithium Carbonate C Insomnia Lisinopril Loss Of Consciousness (Lisinopril) C Major Depression Atorvastatin C Memory Impairment Metformin C Muscle Spasms Risperdal Muscle Twitching (Risperidone) C Nightmare Vitamin B12 C Panic Disorder Zantac Pneumonia (Ranitidine Self Mutilation Hydrochloride) C Sexual Assault Victim Bactrim Ds C Somnolence Erythromycin Suicidal Ideation Syncope (Erythromycin) C Thermal Burn Vistaril Tremor (Hydroxyzine Urinary Tract Infection Embonate) C Vulvovaginal Discomfort Tetracycline C Weight Increased Clonidine C Nicotine Dermal Patch (Nicotine Resin) C Thiamine C Multivitamin C Mylanta C Milk Of Magnesia C Cleocin T (Clindamycin Phosphate) C Artane (Trihexyphenidyl Hydrochloride) C Dulcolax (Bisacodyl) C Diphenhydramine C Neomycin C 24-Jun-2005 12:19 PM Page: 3369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4562194-7Report Type:Expedited (15-DaCompany Report #US_0405102840 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Zyprexa Alpha 1 Foetoprotein Health Increased Professional Anaemia (Olanzapine) PS ORAL 5 MG/1 DAY Blood Albumin Decreased Zoloft Delinquency (Sertraline Gastritis Hydrochloride) C Hepatic Cirrhosis Desyrel Hepatic Steatosis Hepatitis C (Trazodone Hiatus Hernia Hydrochloride) C Liver Function Test Rebetron C Abnormal Interferon C Macrocytosis Ribavirin C Mania Dolobid (Diflunisal) C Oesophagitis Imferon (Iron Platelet Count Decreased Dextran) C Protein Total Decreased Nexium (Esomeprazole Varices Oesophageal Magnesium) C White Blood Cell Count Ibuprofen C Decreased Tramadol C Date:01/21/05ISR Number: 4562197-2Report Type:Expedited (15-DaCompany Report #US_0404101993 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Zyprexa Initial or Prolonged Asthenia Back Pain (Olanzapine) PS ORAL 45 MG/1 AT Biliary Tract Disorder BEDTIME Blood Cholesterol Prozac Abnormal (Fluoxetine Body Temperature Hydrochloride) C Increased Prolixin Dehydration Diabetes Mellitus (Fluphenazine Diabetic Ketoacidosis Hydrochloride) C Diarrhoea Artane Dysuria Gastritis (Trihexyphenidyl Heart Rate Increased Hydrochloride) C Hyperphagia Triamterene/Hydrochl Hypertension orothiazide C Hypoglycaemia Accupril Hyponatraemia (Quinapril Lipase Increased Hydrochloride) C Nausea Asa Obesity (Acetylsalicylic Tachycardia Acid) C Vision Blurred Metoclopramide Vomiting (Metoclopramide Hydrochloride) C Diphenoxylate W/Atropine Sulfate C Atropine W/Hyoscine/Hyoscyami ne/Phenobarbital C 24-Jun-2005 12:19 PM Page: 3370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ultracet C Prilosec (Omeprazole Ratiopharm) C Lithium C Haloperidol (Haloperidol Decanoate) C Valproate Bismuth C Amoxicillin C Hydrocodone W/Acetaminophen C Chlorhexidine Mouthwash (Chlorhexidine Gluconate) C Zithromax Z-Pack (Azithromycin) C Promethazine C Ultram (Tramadol Hydrochloride) C Naproxen (Naproxen Sodium) C Skelaxin (Metaxalone) C Ketorolac C Levaquin (Levofloxacin) C Acetaminophen W/Propoxyphene C Methylprednisolone C Hydrocodone W/Apap C Diltiazem Er (Diltiazem Hydrochloride) C Migrazone C Vicoprofen C Lotrel C Ranitidine C Cyclobenazaprine C Cipro (Ciprofloxacin Hydrochloride) C Carisoprodol C Lorazepam C Augmentin C Ibuprofen C Indomethacin C Methocarbamol C Insulin C Date:01/21/05ISR Number: 4562244-8Report Type:Expedited (15-DaCompany Report #USA041080573 Age:50 YR Gender:Male I/FU:F Outcome PT Other Abdominal Pain Depression Diabetes Mellitus Dizziness Glycosylated Haemoglobin Increased 24-Jun-2005 12:19 PM Page: 3371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypomania Hypotension Impaired Healing Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Consumer Zyprexa-Oral Abnormal Health (Olanzapine) Mania Professional (Olanzapine) PS 50 MG Nausea Lithium C Oedema Depakote (Valproate Paranoia Semisodium) C Pollakiuria Lasix (Furosemide) C Renal Failure Atenolol C Sexual Dysfunction Clonopin Sleep Apnoea Syndrome (Clonazepam) C Somnolence Glucophage Stress (Metformin) C Tachycardia Baycol (Cerivastatin Thirst Sodium) C Treatment Noncompliance Vioxx (Rofecoxib) C Tremor Mellaril Visual Acuity Reduced (Thioridazine Vitreous Floaters Hydrochloride) C Vomiting Weight Increased Date:01/21/05ISR Number: 4562247-3Report Type:Expedited (15-DaCompany Report #US_0501109887 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Zyprexa-Oral Initial or Prolonged Increased (Olanzapine) Aspartate (Olanzapine) PS 5 MG DAY Aminotransferase Vioxx (Rofecoxib) C Increased Hydrocodone W/Apap C Asthma Tramadol C Behcet'S Syndrome Prednisolone C Blood Triglycerides Pediapred Increased (Prednisolone Sodium Condition Aggravated Phosphate) C Dehydration Nexium (Esomeprazole Diabetes Mellitus Magnesium) C Dyspnoea At Rest Sonata (Zaleplon) C Erectile Dysfunction Hydrochlorothiazide C Interstitial Lung Disease Toprol Xl Myocardial Infarction (Metoprolol Nausea Succinate) C Oedema Peripheral Atenolol Pain Chlorthalidone Pneumonitis "Biochemie" C Rash Ambien (Zolpidem Sleep Apnoea Syndrome Tartrate) C Vasculitis Cephalexin C Vomiting Klor-Con M (Potassium Chloride) C Furosemide (Furosemide) C Meperidine W/Promethazine C Prelone (Prednisolone) C Lidocaine C 24-Jun-2005 12:19 PM Page: 3372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Advair C Lotrisone C Amoxicillin Trihydrate/Clavulana te Potassium C Bextra (Valdecoxib) C Mobic (Meloxicam) C Diflucan (Fluconazole) C Levaquin (Levofloxacin) C Azathioprine C Colchicine C Toprol Xl (Metoprolol Succinate) C Sonata (Zaleplon) C Ultram (Tramadol Hydrochloride) C K-Dur (Potassium Chloride) C Levaquin (Levofloxacin) C Lasix (Furosemide) C Mepergan Fortis C Remicade (Infliximab) C Advair C Tenoretic C Cialis (Tadalafil) C Glucotrol (Glipizide) C Zyrtec (Cetirizine Hydrochloride) C Date:01/21/05ISR Number: 4562250-3Report Type:Expedited (15-DaCompany Report #USA050187550 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Consumer Zyprexa-Oral Other Increased (Olanzapine) Cardiomegaly (Olanzapine) PS 40 MG DAY Ativan (Lorazepam) C Date:01/21/05ISR Number: 4562358-2Report Type:Expedited (15-DaCompany Report #USA040979090 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Consumer Zyprexa-Oral Increased Health (Olanzapine) Drug Toxicity Professional (Olanzapine) PS Company Representative 24-Jun-2005 12:19 PM Page: 3373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4562455-1Report Type:Expedited (15-DaCompany Report #JP_040904353 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Foreign Zyprexa-Oral Initial or Prolonged Anorexia Study (Olanzapine) Condition Aggravated Health (Olanzapine) PS 10 MG/1 DAY Nausea Professional Selbex (Teprenone) C Polydipsia Other Dihydergot Schizophrenia, (Dihydroergotamine Disorganised Type Mesilate) C Weight Decreased Effortil (Etilefrine Hydrochloride) C Risumic (Amezinium Metilsulfate) C Somelin (Haloxazolam) C Date:01/21/05ISR Number: 4562457-5Report Type:Expedited (15-DaCompany Report #EWC050142073 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyslipidaemia Foreign Olanzapine-Dispersib Initial or Prolonged Hyperglycaemia Study le (Olanzapine) PS 10 MG DAY Health Professional Other Date:01/21/05ISR Number: 4562458-7Report Type:Expedited (15-DaCompany Report #EWC041241773 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Foreign Zyprexa-Oral Other Increased Health (Olanzapine) Blood Cannabinoids Professional (Olanzapine) PS Increased Other Cardiomegaly Date:01/21/05ISR Number: 4562461-7Report Type:Expedited (15-DaCompany Report #JP_041105133 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) Other Peritonsillar Abscess Professional (Olanzapine) PS 20 MG/1 DAY Company Depromel Representative (Fluvoxamine) C Other Paxil (Paroxetine Hydrochloride) C U-Pan (Lorazepam) C Vegetamin A C Rivotril (Clonazepam) C Flunitrazepam C Doral (Quazepam) C Levotomin (Levomepromazine Maleate) C Unasyn S C 24-Jun-2005 12:19 PM Page: 3374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dalacin-S (Clindamycin) C Loxonin (Loxoprofen Sodium) C Nitrazepam C Sawacillin (Amoxicillin Trihydrate) C Rocephin (Ceftriaxone Sodium) C Date:01/21/05ISR Number: 4562462-9Report Type:Expedited (15-DaCompany Report #JP_050105573 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zyprexa-Oral Hospitalization - Binge Eating Study (Olanzapine) Initial or Prolonged Choking Health (Olanzapine) PS 5 MG/1 DAY Fall Professional Risperdal Restlessness Other (Risperidone) C Akineton (Biperiden Lactate) C Depas (Etizolam) C Depakene (Valpoate Sodium) C Doral (Quazepam) C Desyrel (Trazodone Hydrochloride) C Biasan C Pentona (Mazaticol Hydrochloride) C Hangekoubokutou C Date:01/21/05ISR Number: 4562723-3Report Type:Expedited (15-DaCompany Report #FR_050105541 Age:0 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Zyprexa Initial or Prolonged Pregnancy Health (Olanzapine) PS TRANSPLACENTAL Hypospadias Professional Mepronizine C Hypotonia Neonatal Other Lysanxia (Prazepam) C Effexor (Venlafaxine Hydrochloride) C Aotal (Acamprosate) C Date:01/21/05ISR Number: 4562753-1Report Type:Expedited (15-DaCompany Report #EWC041141519 Age:59 YR Gender:Male I/FU:I Outcome PT Death Convulsion Life-Threatening Electrocardiogram T Wave Hospitalization - Inversion Initial or Prolonged Grand Mal Convulsion Other Hypotension Ischaemia 24-Jun-2005 12:19 PM Page: 3375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa Health Professional (Olanzapine) PS ORAL Company Representative Other Date:01/21/05ISR Number: 4562757-9Report Type:Expedited (15-DaCompany Report #EWC050142158 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Olanzapine Initial or Prolonged Intentional Misuse Health Respiratory Failure Professional (Olanzapine) PS ORAL Suicide Attempt Other Benzodiazepine C Lithium C Serotoninergic Drug Nos C Date:01/21/05ISR Number: 4562910-4Report Type:Expedited (15-DaCompany Report #JP_041004967 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Injury Asphyxiation Study (Olanzapine) Health (Olanzapine) PS 10 MG DAY Professional Amoban (Zopiclone) C Other Brotizolam C Date:01/21/05ISR Number: 4562914-1Report Type:Expedited (15-DaCompany Report #EWC031137009 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) PS 10MG//IN THE Angiopathy Professional EVENING Aspartate Company Haldol (Haloperidol) C Aminotransferase Representative Cisordinol Increased Other (Clopehtixol Blood Glucose Increased Hydrochloride) C Cardiac Disorder Lithium C Drug Toxicity Stesolid (Diazepam) C Gamma-Glutamyltransferase Heminevrin Increased (Clomethiazole Nervousness Edisilate) C Pulmonary Oedema Refusal Of Treatment By Patient Snoring Somnolence Swelling Treatment Noncompliance 24-Jun-2005 12:19 PM Page: 3376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4563736-8Report Type:Expedited (15-DaCompany Report #US_0411108017 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Symbyax-Olanzapine Contusion Health 6mg / Fluoxetine Convulsion Professional 50mg (Olanzapin PS Economic Problem Company Irritability Representative Date:01/21/05ISR Number: 4563737-XReport Type:Expedited (15-DaCompany Report #USA041183296 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Symbiax-Olanzapine Other Blood Creatinine Professional 6mg / Fluoxetine Increased Company 25mg (Olanzapin PS Blood Glucose Increased Representative Klonopin Blood Potassium Increased (Clonazepam) C Blood Pressure Percocet C Immeasurable Body Temperature Decreased Cardio-Respiratory Arrest Coma Completed Suicide Cyanosis Lividity Multiple Drug Overdose Pco2 Decreased Pupil Fixed Treatment Noncompliance Vomiting White Blood Cell Count Increased Date:01/21/05ISR Number: 4563758-7Report Type:Expedited (15-DaCompany Report #US_0405103329 Age:50 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abscess Initial or Prolonged Alcohol Use Angina Pectoris Back Pain Confusional State Coronary Artery Atherosclerosis Dental Caries Diabetes Mellitus Diplopia Dizziness Fall Glaucoma Hyperkeratosis Hypotension Impaired Healing Joint Dislocation Radius Fracture Syncope Tooth Abscess 24-Jun-2005 12:19 PM Page: 3377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 AT BEDTIME Sinequan (Doxepin Hydrochloride) C Remeron (Mirtazapine Orifarm) C Paxil (Paroxetine Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Multivitamin C Nitrostat (Glyceryl Trinitrate) C Vistaril (Hydroxyzine Embonate) C Timoptic (Timolol Maleate) C Zocor (Simvastatin Ratiopharm) C Cromolyn Sodium C Buspar (Buspirone Hydrochloride) C Coral Calcium C Lisinopril (Lisinopril) C Zetia (Ezetimibe) C Motrin (Ibuprofen) C Vicodin C Aspirin (Acetylsalicylic Acid) C Xalatan C Hydrochlorothiazide C K-Dur (Potassium Chloride) C Alphagan (Brimonidine Tartrate) C Albuterol C Norvasc (Amlodipine) C Axid (Nizatidine) C Magnesium Oxide C Date:01/21/05ISR Number: 4563806-4Report Type:Expedited (15-DaCompany Report #USA041287013 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 3378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4563807-6Report Type:Expedited (15-DaCompany Report #US_0412109199 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Spontaneous Consumer Olanzapine-Oral Alanine Aminotransferase Health (Olanzapine) PS 20 MG Increased Professional Olanzapine-Dispersib Aspartate le (Olanzapine) SS 20 MG Aminotransferase Prozac-Oral Increased (Fluoxetine) Blood Alkaline (Fluoxetine Phosphatase Increased Hydrochloride) SS 90 MG Blood Cholesterol Lorazepam C Increased Metformin C Bronchitis Glyburide C Condition Aggravated Prevacid Diabetes Mellitus (Lansoprazole) C Difficulty In Walking Amoxicillin Drug Exposure During W/Potassium Pregnancy Clavulanate C Fibrocystic Breast Levora C Disease Protonix Gastrooesophageal Reflux (Pantoprazole) C Disease Ambien (Zolpidem Hallucination, Auditory Tartrate) C Headache Amoxil (Amoxcillin Hepatic Enzyme Increased Trihydrate) C Low Density Lipoprotein Oxycodone/Apap C Increased Ciprofloxacin C Metrorrhagia Meperidine C Nephrolithiasis Promethazine C Plantar Fasciitis Zithromax Rash (Azithromycin) C Tenderness Apap W/Codeine C Weight Increased Triamcinolone C Levlen C Ranitidine C Diazepam C Guiatuss (Guaifenesin L.A.) C Cimetidine C Metronidazole C Cleocin (Clindamycin Hydrochloride) C Crotamitrex (Crotamiton) C Naproxen (Naproxen Sodium) C Cefaclor C Allegra (Fexofenadine Hydrochloride) C Cefzil (Cefprozil) C Prednisone C Nasonex (Mometasone Furoate) C Zyrtec (Cetirizine Hydrochloride) C Wellbutrin Sr(Bupropion Hydrochloride) C Benzotropine 24-Jun-2005 12:19 PM Page: 3379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Synthroid (Levothyroxine Sodium) C Date:01/21/05ISR Number: 4564707-8Report Type:Expedited (15-DaCompany Report #2004120941 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Xanax Tablet Initial or Prolonged Depressed Level Of Health (Alprazolam) PS ORAL ORAL Consciousness Professional Amitriptyline Hyponatraemia Hydrochloride (Amitriptyline Hydrochloride) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Paroxetine (Paroxetine) SS ORAL ORAL Donepezil Hydrochloride (Donepezil Hydrochloride) SS ORAL ORAL Prinzide (Hydrochlorothiazide , Lisinopril) C Pantoprazole (Pantoprazole) C Date:01/24/05ISR Number: 4559196-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103393 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Dilatation Risperdal PS Intestinal Dilatation Olanzapine SS Pneumonia Trazadone SS Sepsis Lipostat C Tenormin C Tritace C Aspirine C Digoxine C Atrovent C Warfarin C Date:01/24/05ISR Number: 4559552-3Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0365152A Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Lamictal PS Glaxosmithkline ORAL Initial or Prolonged Disorientation Floxyfral SS ORAL 50MG per day 3 DAY Zyprexa SS ORAL 5MG per day 3 DAY Trittico SS ORAL 200MG per day 3 DAY Bactrim Forte C Glaxosmithkline ORAL Blopress C 16MG per day 3 DAY 24-Jun-2005 12:19 PM Page: 3380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/05ISR Number: 4567757-0Report Type:Direct Company Report #CTU 237805 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Zyprexa 5mg Lilly PS Lilly ORAL 15 MG, QHS PO Initial or Prolonged Diabetes Mellitus Clonazepam C Required Lactic Acidosis Zyprexa C Intervention to Urine Ketone Body Present Lithium C Prevent Permanent Loxapine C Impairment/Damage Lamictal C Seroquel C Effexor Xr C Metformin C Ambien C Date:01/26/05ISR Number: 4564142-2Report Type:Expedited (15-DaCompany Report #JP_050105585 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatotoxicity Foreign Zyprexa-Oral Hospitalization - Platelet Count Decreased Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG DAY Company Depromel Representative (Fluvoxamine) C Other Reslin (Trazodone Hydrochloride) C Amoban (Zopiclone) C Date:01/26/05ISR Number: 4564312-3Report Type:Expedited (15-DaCompany Report #JP_041205473 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Epilepsy Professional (Olanzapine) PS 7.5 MG DAY Hypokalaemia Company Gorei-San C Representative Other Date:01/26/05ISR Number: 4564595-XReport Type:Expedited (15-DaCompany Report #JP_041105133 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) Other Drug Ineffective Professional (Olanzapine) PS 20 MG/1 DAY Nasopharyngitis Company Depromel Peritonsillar Abscess Representative (Fluvoxamine) C Other Paxil (Paroxetine Hydrochloride) C U-Pan (Lorazepam) C Vegetamin A C Rivotril (Clonazepam) C Flunitrazepam C Doral (Quazepam) C Levotomin (Levomepromazine Maleate) C 24-Jun-2005 12:19 PM Page: 3381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unasyn S C Dalacin-S (Clindamycin) C Loxonin (Loxoprofen Sodium) C Nitrazepam C Sawacillin (Amoxicillin Trihydrate) C Rocephin (Ceftriaxone Sodium) C Date:01/26/05ISR Number: 4564598-5Report Type:Expedited (15-DaCompany Report #GBS041115871 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Calcium Decreased Foreign Olanzapine-Oral Hospitalization - Blood Creatine Health (Olanzapine) PS 10 MG Initial or Prolonged Phosphokinase Increased Professional Diazepam C Other Blood Creatinine Other Promazine C Increased Dothiepin C Blood Sodium Decreased Zopiclone Cardiac Failure (Zopiclone) C Cardiomyopathy Hepatic Failure Hepatic Necrosis Multi-Organ Failure Myoglobinuria Rhabdomyolysis Date:01/26/05ISR Number: 4564639-5Report Type:Expedited (15-DaCompany Report #GBS050116399 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Consumer (Olanzapine) Other (Olanzapine) PS 5 MG Date:01/26/05ISR Number: 4564641-3Report Type:Expedited (15-DaCompany Report #US_0501110160 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Olanzapine-Oral Initial or Prolonged Diplopia Literature (Olanzapine) PS 15 MG DAY Dizziness Health Carbamazepine C Drug Level Increased Professional Haloperidol C Drug Toxicity Other Midazolam C Tachycardia Lorazepam C Vomiting Oral Contraceptive Nos C Date:01/26/05ISR Number: 4564643-7Report Type:Expedited (15-DaCompany Report #JP_041205473 Age:20 YR Gender:Female I/FU:I Outcome PT Other Epilepsy Hypokalaemia 24-Jun-2005 12:19 PM Page: 3382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Musculoskeletal Stiffness Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG DAY Company Gorei-San C Representative Other Date:01/26/05ISR Number: 4564645-0Report Type:Expedited (15-DaCompany Report #FR_050105553 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa-Oral Initial or Prolonged Cholelithiasis Health (Olanzapine) Cytolytic Hepatitis Professional (Olanzapine) PS Hepatic Steatosis Other Lepticur Leukocytosis (Tropatepine Pancreatitis Acute Hydrochloride) C Date:01/26/05ISR Number: 4565006-0Report Type:Expedited (15-DaCompany Report #EWC050142155 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Olanzapine Life-Threatening Cardiac Arrest Health -Rapid-Acting Im PS INTRAMUSCULAR 10 MG Sudden Death Professional Valium Other (Diazepam) C Date:01/26/05ISR Number: 4565332-5Report Type:Expedited (15-DaCompany Report #DE_041114641 Age:38 YR Gender:Male I/FU:F Outcome PT Life-Threatening Abdominal Discomfort Hospitalization - Abdominal Pain Upper Initial or Prolonged Asthenia Other Blood Potassium Increased Blood Uric Acid Increased Cholestasis Coagulopathy Diarrhoea Feeling Abnormal Gastric Disorder General Physical Health Deterioration Hepatic Encephalopathy Hepatic Failure Hepatic Necrosis Hepatic Steatosis Hepatocellular Damage Hepatomegaly Hepatorenal Syndrome Hepatotoxicity Hyperkalaemia Hypothyroidism Lipase Abnormal Liver Disorder 24-Jun-2005 12:19 PM Page: 3383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Transplant Mania Pallor Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Foreign Zyprexa-Oral(Olanzap Pleural Effusion Health ine) PS 7.5 MG DAY Vomiting Professional Orifiril (Valproic Other Acid) C Orifiril-Slow Release (Valproate Sodium) C Haldol Decanoate (Haloperidol Decanoate) C Fluanxol Depot (Flupentixol Decanoate) C Fluanxol (Flupentixol Decanoate) C L-Thyroxin (Levothyroxine Sodium) C Betoptima C Artelac (Hypromellose) C Divascan (Iprazochrome) C Atosil (Isopromethazine Hydrochloride) C Diazepam C Date:01/26/05ISR Number: 4565335-0Report Type:Expedited (15-DaCompany Report #EWC041241993 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Olanzapine-Long-Acti Initial or Prolonged Dizziness Study ng Extensor Plantar Response Health (Depot) PS INTRAMUSCULAR 405 MG OTHER General Physical Health Professional Fluanxol Deterioration Other (Flupentixol Medication Error Decanoate) C Miosis Movement Disorder Pupillary Light Reflex Tests Abnormal Schizophrenia, Paranoid Type Sedation Somnolence Speech Disorder Unresponsive To Pain Stimuli Unresponsive To Verbal Stimuli 24-Jun-2005 12:19 PM Page: 3384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4565364-7Report Type:Expedited (15-DaCompany Report #USA041082401 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Fluoxetine-Oral Blister Professional (Fluoxetine) Drug Toxicity Company (Fluoxetine Pulmonary Congestion Representative Hydrochlor PS 40 MG DAY Pulmonary Oedema Olanzapine -Oral Tracheitis (Olanzapine) SS Lithium C Lorazepam C Lexapro (Escitalopram Oxalate) C Date:01/26/05ISR Number: 4565551-8Report Type:Expedited (15-DaCompany Report #USA050187608 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Consumer Zyprexa-Oral Living Impaired (Olanzapine) Asthenia (Olanzapine) PS 7.5 MG DAY Catheterisation Cardiac Prozac (Fluoxetine Communication Disorder Hydrochloride) C Crying Lorazepam C Dyspnoea Emotional Distress Feeling Abnormal Feeling Hot Herpes Zoster Hyperhidrosis Memory Impairment Pruritus Weight Decreased Weight Increased Date:01/26/05ISR Number: 4565562-2Report Type:Expedited (15-DaCompany Report #USA050188021 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Surgery Health Zyprexa-Oral Initial or Prolonged Hiccups Professional (Olanzapine) PS Other Company Representative Date:01/26/05ISR Number: 4565564-6Report Type:Expedited (15-DaCompany Report #USA050187841 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Zyprexa-Oral Condition Aggravated Professional (Olanzapine) PS 15 MG Psychotic Disorder Company Coreg (Carvedilol) C Representative Seroquel (Quetiapine Fumarate) C 24-Jun-2005 12:19 PM Page: 3385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4565572-5Report Type:Expedited (15-DaCompany Report #USA050187583 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa-Oral Haemoglobin Increased Professional Oolanzapine) PS Company Representative Date:01/26/05ISR Number: 4565590-7Report Type:Expedited (15-DaCompany Report #US_0501110086 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:01/26/05ISR Number: 4565600-7Report Type:Expedited (15-DaCompany Report #USA050187675 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar Ii Disorder Company Cymbalta (Duloxetine Depression Representative Hydrochloride) PS 60 MG Depressive Symptom Zyprexa-Oral Disease Recurrence (Olanzapine) Drug Ineffective (Olanzapine) SS 2.5 MG Hypersomnia Benzodiazepine C Mood Altered Suicidal Ideation Syncope Date:01/26/05ISR Number: 4565609-3Report Type:Expedited (15-DaCompany Report #US_0501109724 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Consumer Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG/1 AT Aminotransferase BEDTIME Increased Effexor (Venlafaxine Blood Cholesterol Hydrochloride) C Increased Atenolol C Blood Triglycerides Amitriptyline C Increased Aspirin Blood Urine (Ccetylsalicylic Diabetes Mellitus Acid) C Non-Insulin-Dependent Glucophage Glucose Urine (Metformin) C High Density Lipoprotein Seroquel (Quetiapine Increased Fumarate) C Protein Urine Upper Respiratory Tract Infection 24-Jun-2005 12:19 PM Page: 3386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4565679-2Report Type:Expedited (15-DaCompany Report #US_0409106184 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) Other Breast Pain Professional (Olanzapine) PS 20 MG AT Cellulitis BEDTIME Condition Aggravated Prozac (Fluoxetine Diabetes Mellitus Hydrochloride) C Dizziness Risperidone C Gastric Disorder Venlafaxine C Gastrointestinal Disorder Divalproex Sodium C Gout Luvox (Fluvoxamine Musculoskeletal Pain Maleate) C Staphylococcal Infection Paxil (Paroxetine Subcutaneous Abscess Hydrochloride) C Depakote (Valproate Semisiodium) C Trazadone (Trazodone) C Celexa (Citalopram Hydrobromide) C Effexor (Venlafaxine Hydrochloride) C Hydrochlorothiazide C Vistaril (Hydroxyzine Embonate) C Date:01/26/05ISR Number: 4565681-0Report Type:Expedited (15-DaCompany Report #USA050187381 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 15 MG DAY Representative Date:01/26/05ISR Number: 4565683-4Report Type:Expedited (15-DaCompany Report #US_0501110055 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG AT Representative BEDTIME Zoloft (Sertraline Hydrochloride) C Date:01/26/05ISR Number: 4568993-XReport Type:Direct Company Report #CTU 238044 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 24-Jun-2005 12:19 PM Page: 3387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Depression Olanzapine PS ORAL PO Hypotension Amantadine C Hypothermia Atorvastatin C Thiothixene C Lisinopril C Atenolol C Calcium Carbonate C Heparin C Date:01/27/05ISR Number: 4565153-3Report Type:Direct Company Report #CTU 238308 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Olanzapine PS ORAL 20MG DAILY PO 8 DAY Trismus Date:01/27/05ISR Number: 4565155-7Report Type:Direct Company Report #CTU 238306 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Olanzapine PS ORAL 5MG DAILY PO Date:01/27/05ISR Number: 4565157-0Report Type:Direct Company Report #CTU 238305 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Olanzapine PS ORAL 15MG PO Date:01/27/05ISR Number: 4565174-0Report Type:Direct Company Report #CTU 238340 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Zyprexa PS 20 MG DAILY Paraesthesia (THERAPY Rash DATES: SEE Tardive Dyskinesia ITEM B5) Weight Increased Trileptal C Cogentin C Benadryl C Date:01/27/05ISR Number: 4567295-5Report Type:Expedited (15-DaCompany Report #2005014959 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Balance Disorder Bipolar Disorder Blood Potassium Increased Blood Pressure Increased Bronchitis Condition Aggravated Crying Depression 24-Jun-2005 12:19 PM Page: 3388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Difficulty In Walking Dizziness Fatigue Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Consumer Neurontin (Gabapentin) PS Geodon (Ziprasidone) SS ORAL 120 MG ORAL Gabapentin (Gabapentin) SS Buspirone Hydrochloride (Buspirone Hydrochloride) SS Olanzapine (Olanzapine) SS All Other Non-Therapeutic Products SS Diphenhydramine Hydrochloride C Clomipramine C Pantoprazole C Metoprolol (Metoprolol) C Amlodipine Besilate (Amlodipine Besilate) C Valsartan (Valsartan) C Pravastatin Sodium (Pravastatin Sodium) C Triamcinolone (Triamcinolone) C Ciclopirox Olamine (Ciclopirox Olamine) C Miconazole (Miconazole) C Date:01/27/05ISR Number: 4575363-7Report Type:Direct Company Report #CTU 238299 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Olanzapine PS ORAL 10MG PO Feeling Jittery Risperidone C Tachycardia Fluoxetine C 24-Jun-2005 12:19 PM Page: 3389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/05ISR Number: 4580111-0Report Type:Periodic Company Report #USA040979500 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysuria Consumer Strattera Insomnia (Atomoxetine Joint Swelling Hydrochloride) PS 40 MG/2 DAY Migraine Zyprexa-Oral Oedema Peripheral (Olanzapine) Vision Blurred (Olanzapine) SS Wheezing Albuterol C Prilosec (Omeprazole) C Fluoxetine C Date:01/27/05ISR Number: 4580308-XReport Type:Periodic Company Report #USA040670571 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Prozac-Oral Anxiety (Fluoxetine) Asthenia (Fluoxetine Diabetes Mellitus Hydrochloride) PS Non-Insulin-Dependent Zyprexa-Oral Drug Ineffective (Olanzapine) Drug Interaction (Olanzapine) SS 10 MG/3 DAY Fear Symbyax-Olanzapine Hypersomnia 12mg (Fluoxetine 25 Increased Appetite Mg (Olanzapine SS Initial Insomnia Strattera Major Depression (Atomoxetine Mood Swings Hydrochloride) SS 40 MG/2DAY Negativism Geodon (Ziprasidone Oedema Hydrochloride) C Prescribed Overdose Diovan (Valsartan) C Suicidal Ideation Diltiazem C Tinnitus Clonidine C Tremor Oxybutynin C Weight Vitamin E C Weight Increased Pravaxhol (Pravastatin Sodium) C Metformin C Actos "Takeda" (Pioglitazone) C Aspirin Enteric Coated K.P. (Acetylsalicylic Acid) C Seroquel (Quetiapine Fumarate) C Paxil Iparoxetine Hydrochloride) C Fluvoxamine Maleate C Date:01/27/05ISR Number: 4599224-2Report Type:Periodic Company Report #USA041082517 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Strattera Somnolence (Atomoxetine 24-Jun-2005 12:19 PM Page: 3390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) PS 60 MG DAY Zyprexa-Oral (Olanzapine) (Olanzapine) SS 1.25 MG DAY Glucophage (Metformin) C Zantac (Ranitidine Hydrochloride) C Zocor (Simvastatin Ratiopharm) C Aspirin (Acetylsalicylic Acid) C Date:01/31/05ISR Number: 4565627-5Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050103393 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Dilatation Risperdal PS Intestinal Dilatation Olanzapine SS Pneumonia Trazadone SS Sepsis Lipostat C Tenormin C Tritace C Aspirine C Digoxine C Atrovent C Warfarin C Date:02/01/05ISR Number: 4567088-9Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200500181 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Plavix PS ORAL Initial or Prolonged Disorientation Zyprexa SS ORAL Encephalopathy Allopurinol SS ORAL Hallucination, Visual Temesta SS ORAL Hyperreflexia Zocor C ORAL UNK Myoclonus Imovane C ORAL UNK Date:02/01/05ISR Number: 4569469-6Report Type:Expedited (15-DaCompany Report #US_0501111019 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:02/01/05ISR Number: 4569490-8Report Type:Expedited (15-DaCompany Report #US_0501111017 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/05ISR Number: 4569573-2Report Type:Expedited (15-DaCompany Report #K200500036 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Sonata (Zaleplon) Initial or Prolonged Fatigue Health Capsule, 5mg PS ORAL 70 MG, (14 Hypoglycaemia Professional CAPSULES), Hypotension Other SINGLE, ORAL Intentional Misuse Cipramil (Citalopram Mydriasis Hydrochloride) Ventricular Extrasystoles Tablet, 400mg SS ORAL 400 MG, (20 Vertigo TABLETS), SINGLE, ORAL Tafil (Alprazolam) Tablet, 20 Mg SS ORAL 20 MG, (20 TABLETS), SINGLE, ORAL Zyprexa (Olanzapine) Tablet, 50 Mg SS ORAL 50 MG, (10 TABLETS), SINGLE, ORAL Date:02/01/05ISR Number: 4598800-0Report Type:Direct Company Report #CTU 241702 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Olanzapine 7.5 Mg PS ORAL 7.5 MG HS Initial or Prolonged Hypotension ORAL Carbidopa/Levodopa 25 Mg/100 Mg SS ORAL 25/100 QID ORAL Apap C Alendronate C Asa C Calcium /Vit D C Docuate C Multiitamin With Minerals C Omeprazole C Paroxetine C Date:02/02/05ISR Number: 4570636-6Report Type:Expedited (15-DaCompany Report #US_0501110337 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Death Of Parent Foreign Olazapine Initial or Prolonged Imprisonment Consumer Other Murder Health (Olanzapine) PS 20 MG/L DAY Treatment Noncompliance Professional Carbamazepine C Other Risperidone C Date:02/02/05ISR Number: 4570708-6Report Type:Expedited (15-DaCompany Report #EWC050142237 Age:62 YR Gender:Male I/FU:I Outcome PT Other Erythema Haematocrit Decreased Haemoglobin Decreased Oedema Peripheral 24-Jun-2005 12:19 PM Page: 3392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Maculo-Papular Red Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG DAY Professional Lamictal Other (Lamotrigine) C Seroquel (Quetiapine Fumarate) C Moduretic C Pantozol (Pantoprazole Sodium) C Valium (Diazepam) C Date:02/02/05ISR Number: 4570709-8Report Type:Expedited (15-DaCompany Report #GBS050116380 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Foreign Olanzapine-Oral Hospitalization - Decreased Activity Health (Olanzapine) PS 20 MG Initial or Prolonged Professional Haloperidol C Other Company Representative Other Date:02/02/05ISR Number: 4570710-4Report Type:Expedited (15-DaCompany Report #EWC050142236 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Foreign Zyprexa-Oral Torticollis Health (Olanzapine) PS Professional Naltrexone C Other Date:02/02/05ISR Number: 4570711-6Report Type:Expedited (15-DaCompany Report #CA_050107645 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Zyprexa-Oral Other Health (Olanzapine) PS Professional Paxil (Paroxetine Company Hydrochloride) C Representative Other Date:02/02/05ISR Number: 4570712-8Report Type:Expedited (15-DaCompany Report #EWC050142289 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Zyprexa-Oral Hospitalization - Septic Shock Other (Olanzapine) PS 5 MG/1 DAY Initial or Prolonged Prolopa C Depakine (Valproate Sodium) C Diphantoine (Pheytoin Sodium) C 24-Jun-2005 12:19 PM Page: 3393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Betoptic (Betaxolol Hydrochloride) C Date:02/02/05ISR Number: 4570713-XReport Type:Expedited (15-DaCompany Report #FR_050105629 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zyprexa-Oral Initial or Prolonged Urinary Retention Health (Olanzapine) PS 20 MG DAY Professional Xanax (Alprazolam Company Dum) C Representative Tercian Other (Cyamemazine) C Date:02/02/05ISR Number: 4570716-5Report Type:Expedited (15-DaCompany Report #CA_050107662 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:02/02/05ISR Number: 4570755-4Report Type:Expedited (15-DaCompany Report #JP_050105585 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa Hospitalization - Increased Health (Olanzapine) PS 2.5 MG DAY Initial or Prolonged Aspartate Professional Depromel Aminotransferase Company (Fluvoxamine) C Increased Representative Reslin Blood Alkaline Other (Trazodone Phosphatase Increased Hydrochloride) C Gamma-Glutamyltransferase Amoban Increased (Zopiclone) C Hepatotoxicity Magnesium Oxide C Liver Disorder Pursennid C Thrombocytopenia Amicaliq C Date:02/02/05ISR Number: 4570759-1Report Type:Expedited (15-DaCompany Report #FR_050105608 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa-Oral Initial or Prolonged Trismus Health (Olanzapine) PS 30 MG/1 DAY Professional Haldol (Haloperidol Other Decanoate) C Sulfarlem (Anethole Trithione) C Date:02/02/05ISR Number: 4570760-8Report Type:Expedited (15-DaCompany Report #FR_050105635 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Pseudo Lymphoma Foreign Initial or Prolonged Rash Generalised Health 24-Jun-2005 12:19 PM Page: 3394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Zyprexa -Oral(Olanzapine) PS 10 MG/1 DAY Depamide (Valpromide) C Lepticur (Tropatepine Hydrochloride) C Tranxene (Cloazepate Dipotassium) C Date:02/02/05ISR Number: 4570761-XReport Type:Expedited (15-DaCompany Report #GBS041216262 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Olanzapine-Oral Initial or Prolonged Neuroleptic Malignant Health (Olanzapine) PS 10 MG/1 DAY Syndrome Professional Efexor (Venlafaxine) C Other Date:02/02/05ISR Number: 4570762-1Report Type:Expedited (15-DaCompany Report #GBS050116410 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Swelling Foreign Olanzapine-Oral Hypersensitivity Health (Olanzapine) PS 10 MG Lymphadenopathy Professional Cannabis C Rhinitis Other Date:02/02/05ISR Number: 4570763-3Report Type:Expedited (15-DaCompany Report #AU_050108319 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Olanzapine-Oral Initial or Prolonged Alcohol Interaction Health (Olanzapine) PS 30 MG Delirium Professional Paracetamol C Depressed Mood Company Methadone C Hepatic Encephalopathy Representative Clonazepam C Prescribed Overdose Other Toothache Date:02/02/05ISR Number: 4570767-0Report Type:Expedited (15-DaCompany Report #JP_041004648 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aspartate Foreign Zyprexa-Oral Aminotransferase Health (Olanzapine) Increased Professional (Olanzapine) PS 10 MG DAY Gamma-Glutamyltransferase Company Increased Representative Hepatic Function Abnormal Other 24-Jun-2005 12:19 PM Page: 3395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4570769-4Report Type:Expedited (15-DaCompany Report #JP_041004651 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa-Oral Increased Study (Olanzapine) Aspartate Health (Olanzapine) PS 5 MG DAY Aminotransferase Professional Rohypnol Increased Other (Flunitrazepam Eg) C Hepatic Function Abnormal Date:02/02/05ISR Number: 4570770-0Report Type:Expedited (15-DaCompany Report #CA_040607043 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphagia Foreign Zyprexa-Oral Hospitalization - Blood Urine Present Consumer (Olanzapine) Initial or Prolonged Cerebrovascular Accident (Olanzapine) PS 7.5 MG/2 DAY Other Cognitive Disorder Coumadin (Warfarin Dehydration Sodium) C Depressed Level Of Consciousness Dysarthria Dysphagia Fall Hypersomnia Muscle Atrophy Musculoskeletal Stiffness Pain Urethritis Weight Decreased Date:02/02/05ISR Number: 4570771-2Report Type:Expedited (15-DaCompany Report #EWC050142158 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Olanzapine-Oral Initial or Prolonged Respiratory Failure Health (Olanzapine) PS Suicide Attempt Professional Benzodiazepine C Company Lithium C Representative Serotoninergic Drug Nos C Date:02/02/05ISR Number: 4570781-5Report Type:Expedited (15-DaCompany Report #FR_041205360 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa-Oral Face Oedema Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Norset (Mirtazapine Representative Orifarm) C Other Ogast (Lansoprazole) C Rivotril (Clonazepam) C 24-Jun-2005 12:19 PM Page: 3396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4570782-7Report Type:Expedited (15-DaCompany Report #EWC050142117 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Foreign Zyprexa-Oral Pituitary Cyst Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Zyprexa-Rapid-Acting Im (Olanzapine) SS 10 MG DAY Date:02/02/05ISR Number: 4570783-9Report Type:Expedited (15-DaCompany Report #JP_040703759 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Zyprexa-Oral Head Injury Study (Olanzapine) Headache Health (Olanzapine) PS 5 MG/1 DAY Hypertension Professional Serenace Loss Of Consciousness Other (Haloperidol) C Artane (Trihexyphenidyl Hydrochloride) C Magnesium Oxide C Adalat (Nifedipine) C Diovan C Date:02/02/05ISR Number: 4571164-4Report Type:Expedited (15-DaCompany Report #FR_050105649 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injection Site Reaction Foreign Zyprexa Initial or Prolonged Medication Error Health Rapid Acting Im PS 10 MG/1 HOUR Professional Loxapac (Loxapine Other Succinate) C Date:02/02/05ISR Number: 4571190-5Report Type:Expedited (15-DaCompany Report #JP_040904599 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chromosome Abnormality Foreign Zyprexa-Oral Hospitalization - Condition Aggravated Health (Olanzapine) Initial or Prolonged Myelodysplastic Syndrome Professional (Olanzapine) PS 5 MG DAY Refractory Anaemia With Company Risperdal An Excess Of Blasts Representative (Risperidone) C Other Hydantol D C Neophyllin (Aminophylline) C Benzalin (Nitrazepam) C Tasmolin (Biperiden) C Date:02/02/05ISR Number: 4571192-9Report Type:Expedited (15-DaCompany Report #US_021088722 Age:31 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate 24-Jun-2005 12:19 PM Page: 3397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Condition Aggravated Depressed Level Of Report Source Product Role Manufacturer Route Dose Duration Consciousness Foreign Zyprexa-Oral Formication Literature (Olanzapine) Intentional Misuse Health (Olanzapine) PS 100 MG DAY Rhabdomyolysis Professional Risperidone C Schizophrenia Company Stress Representative Suicide Attempt Date:02/02/05ISR Number: 4571193-0Report Type:Expedited (15-DaCompany Report #JP_040102551 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa-Oral Initial or Prolonged Disease Recurrence Literature (Olanzapine) Drug Interaction Health (Olanzapine) PS 40 MG DAY Hyperprolactinaemia Professional Serenace Mania Company (Haloperidol) C Pulmonary Embolism Representative Lithium Carbonate C Other Levomepromazine C Clonazepam C Biperiden C Promethazine Hydrochloride C Magnesium Oxide C Date:02/02/05ISR Number: 4571208-XReport Type:Expedited (15-DaCompany Report #US_0501111007 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Consumer Zyprexa-Oral Pancreatitis (Olanzapine) (Olanzapine) PS Date:02/02/05ISR Number: 4571209-1Report Type:Expedited (15-DaCompany Report #USA050188250 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Consumer Zyprexa-Oral Initial or Prolonged Amnesia (Olanzapine) Disability Diarrhoea (Olanzapine) PS Hydrocephalus Cymbalta (Duloxetine Hyperhidrosis Hydrochloride) SS 30 MG/1 DAY Movement Disorder Ibuprofen C Nausea Nexium (Esomeprazole Neuropathy Magnesium) C Thinking Abnormal Ritalin (Methylphenidate Hydrochloride) C Provigil (Modafinil) C Pamelor (Nortriptyline Hydrochloride) C Valium (Diazepam) C 24-Jun-2005 12:19 PM Page: 3398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4571210-8Report Type:Expedited (15-DaCompany Report #USA050188252 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Mouth Consumer Zyprexa-Oral Initial or Prolonged Erectile Dysfunction (Olanzapine) Incontinence (Olanzapine) PS 20 MG/1 DAY Insomnia Fluoxetine-Oral Malaise (Fluoxetine) Mental Disorder (Fluoxetine Nervousness Hydrochlor SS Weight Increased Date:02/02/05ISR Number: 4571211-XReport Type:Expedited (15-DaCompany Report #US_0411108051 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Zyprexa-Oral Blood Cholesterol Health (Olanzapine) Increased Professional (Olanzapine) PS 10 MG/2 AT Blood Glucose Decreased BEDTIME Blood Glucose Increased Zantac (Ranitidine Diabetes Mellitus Hydrochloride) C Non-Insulin-Dependent Demerol (Fethidine Dysarthria Hydrochloride) C Fall Xanax (Alprazolam Flushing Dum) C Headache Fioricet C Hyperglycaemia Elavil Hypoaesthesia (Amitriptyline Laceration Hydrochloride) C Loss Of Consciousness Lipitor Migraine (Atorvastatin Nausea Calcium) C Pancreatitis Nubain (Nalbuphine) C Paraesthesia Vistaril Road Traffic Accident (Hydroxyzine Skin Injury Embonate) C Vomiting Toradol(Ketorolac Weight Increased Tromethamine) C Prilosec (Omeprazole Ratiopharm) C Droperidol C Phenergan (Promethazine Hydrochloride) C Inderal (Propranolol Hydrochloride) C Sinequan (Doxepin Hydrochloride) C Cholestyramine Resin C Benadryl C Valium (Diazepam) C Glucotrol (Glipizide) C Elavil (Amitriptyline Hydrochloride) C Zyrtec (Cetirizine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4571212-1Report Type:Expedited (15-DaCompany Report #US_0410107353 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Consumer Zyprexa-Oral Initial or Prolonged Thromboplastin Time Health (Olanzapine) Other Prolonged Professional (Olanzapine) PS 20 MG/1 AT Ascites BEDTIME Blood Fibrinogen Toradol (Ketorolac Increased Tromethamine) C Blood Triglycerides Protonix Increased (Pantoprazole) C Chest Pain Flagyl Cholelithiasis (Metronidazole Confusional State Benzoate) C Cough Duragesic (Fentanyl) C Diarrhoea Acyclovir Dyspepsia (Aciclovir) C Dyspnoea Depakote (Valproate Dysuria Semisodium) C Fluid Imbalance Fluconazole C Folate Deficiency Nicoderm (Nicotine) C Haematocrit Decreased Effexor (Venlfaxine Haemoglobin Decreased Hydrochloride) C Hallucination Acetaminophen C Hypercalcaemia Hydrocodone C Hyperlipidaemia Diphenhydrmaine C Hypoalbuminaemia Lorazepam C Hypocalcaemia Zofran (Ondansetron Hypokalaemia Hydrochloride) C Insomnia Phenergan Lactic Acidosis (Promethazine Leukocytosis Hydrochloride) C Metabolic Acidosis Imipenem C Pancreatitis Lasix (Furosemide) C Pleural Effusion Vitamin K C Prothrombin Time Potassium Phosphate C Prolonged Demerol (Pethidine Pyrexia Hydrochloride) C Tachycardia Multivitamin C Thrombocythaemia Mefoxin (Cefoxitin Urinary Tract Infection Sodium) C Fungal Potassium Chloride C Vaginal Haemorrhage Calcium Gluconate C Visual Disturbance Procalamine C Vitamin B12 Deficiency Albumin Human C Weight Increased Pancrease (Pancrelipase) C Tricor (Fenofibrate) C Vitamin B12 C Folic Acid C Soma (Carisoprodol) C Date:02/02/05ISR Number: 4571213-3Report Type:Expedited (15-DaCompany Report #US_0409105872 Age:47 YR Gender:Female I/FU:I Outcome PT Other Abdominal Distension Acute Sinusitis Aerophagia Alanine Aminotransferase 24-Jun-2005 12:19 PM Page: 3400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Allergic Sinusitis Arthralgia Aspartate Aminotransferase Decreased Back Pain Blood Cholesterol Increased Blood Creatinine Increased Blood Glucose Increased Blood Pressure Increased Blood Sodium Increased Blood Thyroid Stimulating Hormone Increased Bronchitis Bronchitis Acute Cardiac Disorder Chest Pain Constipation Coronary Artery Disease Crying Dermatitis Allergic Diabetes Mellitus Non-Insulin-Dependent Fall Fatigue Fibrocystic Breast Disease Flatulence Fungal Infection Gastrointestinal Haemorrhage Gastrooesophageal Reflux Disease Headache Hot Flush Hyperlipidaemia Hypertension Influenza Injury Joint Sprain Lactose Intolerance Laryngitis Lice Infestation Loss Of Consciousness Low Density Lipoprotein Increased Major Depression Menopausal Symptoms Neck Pain Nervousness Osteoarthritis Osteoporosis Ovarian Cyst Pelvic Pain Peptic Ulcer Periodontal Disease Psychotic Disorder Pyrexia Rhinitis Allergic 24-Jun-2005 12:19 PM Page: 3401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Scleral Disorder Scratch Sinusitis Report Source Product Role Manufacturer Route Dose Duration Tinea Pedis Consumer Zyprexa-Oral Upper Respiratory Tract (Olanzapine) Infection (Olanzapine) PS 10 MG AT Urinary Tract Infection BEDTIME Fungal Effexor-Xr Vaginal Infection (Venlafaxine Vaginitis Bacterial Hydrochloride) C Vascular Occlusion Elavil Viral Upper Respiratory (Amitriptyline Tract Infection Hydrochloride) C Protonix (Pantoprazole) C Pamine (Hyoscine Methobromide) C Miralax (Macrogol) C Premarin C Lotrel C Depo-Estradiol C Date:02/02/05ISR Number: 4571254-6Report Type:Expedited (15-DaCompany Report #US_0501110976 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Consumer Zyprexa-Oral Renal Disorder (Olanzapine) PS Date:02/02/05ISR Number: 4571255-8Report Type:Expedited (15-DaCompany Report #US_0501110500 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Consumer Zyprexa-Oral Hospitalization - Deep Vein Thrombosis (Olanzapine)(Olanzap Initial or Prolonged Diabetic Ketoacidosis ine) PS 10 MG Electrolyte Imbalance Prozac-Oral Hallucination, Visual (Fluoxetine) Headache (Fluoxetine Oedema Peripheral Hydrochloride) SS 20 MG/ 1 DAY Skin Laceration Celexa (Citalopram Toothache Hydrobromide) C Ativan (Lorazepam) C Trazadone (Trazodone) C Ibuprofen C Paxil (Paroxetine Hydrochloride) C Serzone (Nefazodone Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Risperdal (Risperidone) C 24-Jun-2005 12:19 PM Page: 3402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4571978-0Report Type:Expedited (15-DaCompany Report #US_0501110374 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Zyprexa-Oral Back Pain Health (Olanzapine0 PS 15 MG/1 AT Blood Glucose Increased Professional BEDTIME Blood Triglycerides Bupropion Increased Hydrochloride C Cholelithiasis Lithium Carbonate C Condition Aggravated Thiothixine C Corneal Reflex Decreased Amoxicillin C Diabetes Mellitus Escitalopram Oxalate C Insulin-Dependent Lamotrigine C Diabetic Ketoacidosis Esomeprazole Empyema Magnesium C Eye Disorder Pantoprazole C Hallucination, Auditory Rosuvastatin Calcium C Hypercholesterolaemia Hydrocodone C Illusion Haloperidol Pseudomonas Infection Decanoate C Pyrexia Lansoprazole C Sepsis Rofecoxib C Sleep Apnoea Syndrome Sputum Culture Positive Staphylococcal Infection Weight Increased Date:02/02/05ISR Number: 4572058-0Report Type:Expedited (15-DaCompany Report #US_0501111012 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) (Olanzapine) PS Date:02/02/05ISR Number: 4572060-9Report Type:Expedited (15-DaCompany Report #US_0501110274 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Health Zyprexa-Oral Initial or Prolonged Caesarean Section Professional (Olanzapine) Drug Exposure During (Olanzapine) PS Pregnancy Valium (Diazepam) C Feeding Problem In Child Paxil (Paroxetine Hydrochloride) C Clonapam ( Clonazepam) C Date:02/02/05ISR Number: 4572061-0Report Type:Expedited (15-DaCompany Report #US_0405102979 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Diabetic Ketoacidosis (Olanzapine) (Olanzapine) PS 15 MG 24-Jun-2005 12:19 PM Page: 3403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4572062-2Report Type:Expedited (15-DaCompany Report #US_0501109908 Age: Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:02/02/05ISR Number: 4572079-8Report Type:Expedited (15-DaCompany Report #S04-USA-07843-01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Health Namenda (Memantine) PS Professional Zyprexa (Olanzapine) SS Company Representative Date:02/02/05ISR Number: 4572097-XReport Type:Expedited (15-DaCompany Report #USA050188786 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Symbyax-Olanzapine Professional 6mg / Fluoxetine Company 25mg (Olanzapin PS 2 DAY Representative Date:02/02/05ISR Number: 4572104-4Report Type:Expedited (15-DaCompany Report #US_0409105409 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine) Blood Triglycerides Professional (Olanzapine) PS 10 MG DAY Increased Olanzipine/Fluoxetin Depression e Capsule C Diabetes Mellitus Celexa (Citalopram Non-Insulin-Dependent Hydrobromide) C Erectile Dysfunction Anafranil Headache (Clomipramine Myocardial Infarction Hydrochloride) C Weight Increased Lotrel C Prednisolone C Prednisone (Prednisone) C Hydrochlorothiazide C Viagra (Sildenafil Citrate) C Darvocet-N C Aspirin (Acetylsalicylic Acid) C Zyrtec (Cetirizine Hydrochloride) C Nasonex (Mometasone Furoate) C Allegra (Fexofenadine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4572105-6Report Type:Expedited (15-DaCompany Report #US_0405102953 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa-Oral Initial or Prolonged Blood Cholesterol Health (Olanzapine) Increased Professional (Olanzapine) PS 30 MG/1 DAY Blood Triglycerides Haloperidol C Increased Paxil (Paroxetine Diabetes Mellitus Hydrochloride) C Insulin-Dependent Accupril (Quinapril Diabetes Mellitus Hydrochloride) C Non-Insulin-Dependent Seroquel (Quetiapine Gastroenteritis Fumarate) C Hypertension Abilify Otitis Externa (Aripiprazole) C Otitis Media Multivitamin C Prescribed Overdose Folate Sodium C Splenic Haemorrhage Splenic Rupture Weight Decreased Weight Increased Date:02/02/05ISR Number: 4572106-8Report Type:Expedited (15-DaCompany Report #US_0501110001 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Consumer Zyprexa-Oral Blood Triglycerides Health (Olanzapine) Increased Professional (Olanzapine) PS Diabetes Mellitus Buspar (Buspirone Insulin-Dependent Hydrochloride) C Hyperglycaemia Trazadone Hypertension (Trazodone) C Influenza Loratadine C Insomnia Ketosis Loss Of Consciousness Pancreatitis Tremor Weight Increased Date:02/02/05ISR Number: 4572108-1Report Type:Expedited (15-DaCompany Report #US_0405103329 Age:49 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abscess Initial or Prolonged Angina Pectoris Anxiety Arterial Disorder Back Pain Blood Glucose Increased Cardiac Valve Disease Coronary Artery Atherosclerosis Coronary Artery Disease Dental Caries Depressed Mood Diabetic Complication Diplopia 24-Jun-2005 12:19 PM Page: 3405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disease Recurrence Dizziness Dyspnoea Report Source Product Role Manufacturer Route Dose Duration Fall Consumer Zyprexa-Oral Glaucoma Health (Olanzapine) Hypercholesterolaemia Professional (Olanzapine) PS 20 MG/1 AT Hyperkeratosis BEDTIME Hypertension Sinequan (Doxepin Hypotension Hydrochloride) C Impaired Healing Remeron (Mirtazapine Joint Dislocation Orifarm) C Radius Fracture Paxil (Paroxetine Syncope Hydrochloride) C Tinnitus Zoloft (Sertraline Ulcer Hydrochloride) C Urinary Incontinence Multivitamin C Urinary Tract Infection Nitrostat (Glyceryl Trinitrate) C Vistaril (Hydroxyzine Embonate) C Timoptic (Timolol Maleate) C Zocor (Simvastatin Ratiopharm) C Cromolyn Sodium C Buspar (Buspirone Hydrochloride) C Coral Calcium C Lisinopril (Lisinopril) C Zetia (Ezetimibe) C Motrin (Ibuprofen) C Vicodin C Aspirin (Acetylsalicylic Acid) C Xalatan /Sch/ (Latanoprost) C Hydrochlorothiazide C K-Dur (Potassium Chloride) C Alphagan (Brimonidine Tartrate) C Albuterol C Norvasc (Amlodipine) C Axid (Nizatidine) C Magnesium Oxide C Glucophage (Metformin) C Coumadin (Warfarin Sodium) C Sertraline C Desyrel (Trazodone Hydrochloride) C Thioridazine C 24-Jun-2005 12:19 PM Page: 3406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4572119-6Report Type:Expedited (15-DaCompany Report #USA050188413 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Attention Health Zyprexa-Oral Deficit/Hyperactivity Professional (Olanzapine) Disorder Company (Olanzapine) PS 35 MG DAY Completed Suicide Representative Strattera Drug Level Increased (Atomoxetine Hydrochloride) SS 40 MG/1 DAY Celebrex (Celecoxib) C Zoloft (Sertraline Hydrochloride) C Prozac (Fludoxetine Hydrochloride) C Date:02/02/05ISR Number: 4572131-7Report Type:Expedited (15-DaCompany Report #US_0501111016 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Consumer Zyprexa (Olanzapine) PS ORAL Date:02/02/05ISR Number: 4572132-9Report Type:Expedited (15-DaCompany Report #US_0501111018 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa Hyperglycaemia Hypertension (Olanzapine) PS ORAL Myocardial Infarction Weight Increased Date:02/02/05ISR Number: 4578160-1Report Type:Direct Company Report #CTU 238885 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Olazapine (Zyprexa) PS ORAL 15MG PO Q Initial or Prolonged Gait Disturbance DAILY 6 MON Tremor Prednisone C Lasix C Effexor C Plavix C Date:02/03/05ISR Number: 4569332-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0542637A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Wellbutrin PS Glaxosmithkline UNKNOWN Initial or Prolonged Amitriptyline SS UNKNOWN Fluvoxamine SS UNKNOWN Unknown Medication SS UNKNOWN Phenazopyridine SS Pyridium SS Unknown Medication SS UNKNOWN Zyprexa SS UNKNOWN Alcohol SS 24-Jun-2005 12:19 PM Page: 3407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4574030-3Report Type:Expedited (15-DaCompany Report #2005019377 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercalcaemia Health Neurontin Renal Failure Acute Professional (Gabapentin) PS ORAL 300 MG, ORAL Company Vicodin (Hydrocodone Representative Bitartrate, Paracetamol) SS Olanzapine/Fluoxetin e Hydrochloride (Fluoxetine Hydrochloride) SS 25 MG Date:02/07/05ISR Number: 4576724-2Report Type:Expedited (15-DaCompany Report #USA050188622 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Strattera Increased Professional (Atomoxetine Aspartate Company Hydrochloride) PS 85 MG DAY Aminotransferase Representative Zyprexa-Oral Increased (Olanzapine) Blood Alkaline (Olanzapine) SS 20 MG DAY 4 YR Phosphatase Increased Abilify Blood Calcium Abnormal (Aripiprazole) C Lymphocyte Percentage Lexapro Increased (Escitalopram Monocyte Percentage Oxalate) C Increased Guaifenesin Neutrophil Percentage (Guaifenesin C Decreased Protein Total Abnormal Date:02/07/05ISR Number: 4576739-4Report Type:Expedited (15-DaCompany Report #US_0501111587 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa Oral Renal Failure (Olanzapine)(Olanzap ine) PS Date:02/08/05ISR Number: 4573591-8Report Type:Periodic Company Report #US013626 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Paxil PS Glaxosmithkline ORAL 40MG Unknown Paranoia Provigil SS ORAL 200MG Per day Zyprexa SS ORAL 5MG Twice per day 6 YR Klonopin SS ORAL .5MG Unknown 8 YR Tobramycin SS ORAL 100MG Unknown 3 YR 24-Jun-2005 12:19 PM Page: 3408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4575064-5Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0544096A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Paxil PS Glaxosmithkline Completed Suicide Zyprexa SS Nightmare Accutane SS Date:02/08/05ISR Number: 4577408-7Report Type:Expedited (15-DaCompany Report #DEWYE381731JAN05 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appetite Disorder Foreign Climarest PS ORAL 20 TABLES Initial or Prolonged Arrhythmia Health (OVERDOSE Fatigue Professional AMOUNT: 12.5 Intentional Misuse Other G), ORAL 2 DAY Diazepam (Diazepam) SS ORAL 1 TABLET (10 MG) ORAL 2 DAY Dipiperon (Pipamperone) SS ORAL 100 MG ,ORAL 2 DAY L-Thyroxin (Levothyroxine Sodium) SS ORAL 100 TABLETS (OVERDOSE AMOUNT: 12.5 G) ,ORAL 2 DAY Zyprexa (Olanzapine) SS ORAL 3 TABLETS (OVERDOSE AMOUNT: 30 MG), ORAL 2 DAY Date:02/08/05ISR Number: 4577481-6Report Type:Expedited (15-DaCompany Report #EWC041141408 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Olanzapine Initial or Prolonged Health Dispersible Disability Professional (Olanzapine) PS 10 MG DAY Company Zyloric Representative (Allopurinol) C Other Coumadin (Warfarin Sodium) C Date:02/08/05ISR Number: 4577482-8Report Type:Expedited (15-DaCompany Report #EWC041141409 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa-Rapid-Actiin Initial or Prolonged Syndrome Health g Im (Olanzapine) PS 2 DSG FORM/2 Pneumonia Professional DAY Company Zinacef (Cefuroxime Representative Sodium) C Other Polibar (Barium Sulfate) C Zeldox (Ziprasidone Hydrochloride) C Haloperidol C Akineton (Biperiden Lactate) C 24-Jun-2005 12:19 PM Page: 3409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ciprobay (Ciprofloxacin Hydrochloride) C Paxirasol (Bromhexine Hydrochloride) C Rivotril (Clonazepam) C Augmentin C Leponex (Clozapine) C Date:02/08/05ISR Number: 4577630-XReport Type:Expedited (15-DaCompany Report #S04-FRA-07953-01 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Foreign Seroplex Health (Escitalopram) PS ORAL 10 MG QD PO Professional Zyprexa Other (Olanzapine) SS ORAL 7.5 MG QD PO Seropram (Citalopram Hydrobromide) C Atarax (Hydroxyzine Hydrochloride) C Date:02/09/05ISR Number: 4575617-4Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0349817A Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Bupropion PS Glaxosmithkline ORAL Completed Suicide Topiramate SS ORAL Intentional Misuse Venlafaxine SS ORAL Overdose Olanzapine SS ORAL Date:02/09/05ISR Number: 4577230-1Report Type:Expedited (15-DaCompany Report #2004AL001032 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anion Gap Literature Children'S Apap Blood Ethanol Increased Health Elixir Blood Ph Decreased Professional (Acetaminophen) Completed Suicide (Alpharma) PS Alpharma ORAL PO Depression Infants' Apap Drops Drug Toxicity (Acetaminophen) Haemodialysis (Alpharma) SS Alpharma ORAL PO Pco2 Decreased Aspirin SS ORAL PO Pneumonia Aspiration Olanzapine SS ORAL PO Sinus Tachycardia Pioglitazone C Tachypnoea Simvastatin C 24-Jun-2005 12:19 PM Page: 3410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4577877-2Report Type:Expedited (15-DaCompany Report #EWC050142349 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa-Rapid-Acting Initial or Prolonged Disease Recurrence Health Im (Olanzapine) PS 10 MG DAY Grand Mal Convulsion Professional Depakine (Valproate Hypokalaemia Company Sodium) C Pneumonia Representative Stesolid (Diazepam) C Other Gewacalm (Diazepam) C Date:02/09/05ISR Number: 4578063-2Report Type:Expedited (15-DaCompany Report #US_0501111571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Zyprexa-Oral Initial or Prolonged Somnolence Health (Olanzapine) Suicide Attempt Professional (Olanzapine) PS Other Date:02/09/05ISR Number: 4578073-5Report Type:Expedited (15-DaCompany Report #JP_050105691 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Representative Other Date:02/09/05ISR Number: 4578075-9Report Type:Expedited (15-DaCompany Report #FR_050105702 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Company Representative Other Date:02/09/05ISR Number: 4578086-3Report Type:Expedited (15-DaCompany Report #EWC050142404 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Life-Threatening Pulmonary Embolism Health (Olanzapine) Hospitalization - Professional (Olanzapine) PS Initial or Prolonged Other Seroquel (Quetiapine Fumarate) C Orap (Pimozide) C Leponex (Clozapine) C 24-Jun-2005 12:19 PM Page: 3411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4578088-7Report Type:Expedited (15-DaCompany Report #EWC050142445 Age:10 WK Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Olanzapine-Oral Hospitalization - Diarrhoea Health (Olanzapine) PS Initial or Prolonged Drug Exposure During Professional Pregnancy Other General Physical Health Deterioration Respiratory Tract Infection Viral Salmonellosis Sepsis Date:02/09/05ISR Number: 4578090-5Report Type:Expedited (15-DaCompany Report #EWC050142372 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Olanzapine-Oral Alanine Aminotransferase Health (Olanzapine) PS 10 MG DAY Increased Professional Heroin C Blood Alkaline Other Akineton (Biperiden Phosphatase Increased Lactate) C Blood Bilirubin Increased Algifor (Ibuprofen) C Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Jaundice Nausea Vomiting Date:02/09/05ISR Number: 4578091-7Report Type:Expedited (15-DaCompany Report #FR_050105644 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Foreign Zyprexa-Oral Prolonged Health (Olanzapine) Professional (Olanzapine) PS Other Date:02/09/05ISR Number: 4578094-2Report Type:Expedited (15-DaCompany Report #FR_050105688 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Disorientation Health (Olanzapine) Encephalopathy Professional (Olanzapine) PS 5 MG/1 DAY Hallucination, Visual Other Temesta (Lorazepam) C Hyperreflexia Allopureinol C Myoclonus Plavix (Clopidogrel) C Imovane (Zopiclone) C Zocor (Simvastatin Ratiopharm) C 24-Jun-2005 12:19 PM Page: 3412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4578095-4Report Type:Expedited (15-DaCompany Report #FR_050105687 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperthermia Foreign Zyprexa-Oral Hospitalization - Malaise Health (Olanzapine) Initial or Prolonged Pulmonary Embolism Professional (Olanzapine) PS 20 MG DAY Company Tercian Representative (Cyamemazine) C Other Xanax (Alprazolam) C Date:02/09/05ISR Number: 4578184-4Report Type:Expedited (15-DaCompany Report #USA050188920 Age:100 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa-Oral Initial or Prolonged Confusional State (Olanzapine) Other (Olanzapine) PS Ritalin (Methylphenidate Hydrochloride) C Date:02/09/05ISR Number: 4578186-8Report Type:Expedited (15-DaCompany Report #USA050187780 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Zyprexa-Oral Carbon Monoxide Poisoning Professional (Olanzapine) Completed Suicide Company (Olanzapine) PS 2.5 MG Representative Cymbalta (Duloxetine Hydrochloride) SS 20 MG/2 DAY Lorazepam C Lamictal (Lamotrigine) C Gabitril (Tiagabine Hydrochloride) C Duragesic (Fentanyl) C Date:02/09/05ISR Number: 4578202-3Report Type:Expedited (15-DaCompany Report #US_0501110994 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) (Olanzapine) PS Date:02/09/05ISR Number: 4578203-5Report Type:Expedited (15-DaCompany Report #US_0411108016 Age:13 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Decreased Appetite Electroencephalogram Abnormal Excoriation Feeling Guilty Glycosylated Haemoglobin Increased 24-Jun-2005 12:19 PM Page: 3413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Self-Injury Polydipsia Polyuria Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Consumer Zyprexa-Oral Suicidal Ideation (Olanzapine) Vision Blurred (Olanzapine) PS 20 MG Lamotrigine C Escitalopram C Ferrous Sulfate (Ferrous Sulfate) C Diphenhydramine C Litium Carbonate (Lithium Carbonate) C Quetiapine C Risperidone C Date:02/09/05ISR Number: 4578205-9Report Type:Expedited (15-DaCompany Report #US_0410106363 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Abnormal (Olanzapine) Blood Triglycerides (Olanzapine) PS 20 MG Increased Depakote 9valproate Diabetes Mellitus Semisodium) C Hepatitis Viral Depakene (Valproate Hyperglycaemic Sodium) C Hyperosmolar Nonketotic Zoloft (Setraline Syndrome Hydrochloride) C Obesity Insulin C Metformin C Date:02/09/05ISR Number: 4578212-6Report Type:Expedited (15-DaCompany Report #US_0406103668 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Apathy Initial or Prolonged Arthralgia Blood Cholesterol Abnormal Blood Triglycerides Increased Crying Depression Diabetes Mellitus Euphoric Mood Fatigue Hyperglycaemia Hypertension Hypoglycaemia Insomnia Irritability Logorrhoea Mania Pain In Extremity Polydipsia Polyuria Pressure Of Speech Sedation 24-Jun-2005 12:19 PM Page: 3414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sexual Activity Increased Treatment Noncompliance Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Glucotrol (Glipizide) C Penta-Triameterene Hctz C Nexium (Esomeprazole Magnesium) C Premarin C Synthroid (Levothyroxine Sodium) C Tricor (Fenofibrate0 C Aripiprazole C Haldol (Haloperidol Decanoate) C Lithium C Lorazepam C Resttoril (Temazepam) C Ambien (Zolpidem Tartrate) C Hydrocodone W/Apap C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Date:02/09/05ISR Number: 4578215-1Report Type:Expedited (15-DaCompany Report #USA050189116 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Ulcerative Consumer Zyprexa-Oral Hospitalization - Crohn'S Disease (Olanzapine) Initial or Prolonged Gastric Ulcer (Olanzapine) PS 10 MG/1 AT Other Hyperphagia BEDTIME Influenza Lithium C Rectal Haemorrhage Vomiting Weight Increased Date:02/09/05ISR Number: 4578219-9Report Type:Expedited (15-DaCompany Report #USA050188957 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Health Zyprexa-Oral Other Increased Professional (Olanzapine) Road Traffic Accident Company (Olanzapine) PS 10 MG/1 DAY Representative Hhaldol Decanoate (Haloperidol Decanoate0 C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 3415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4578285-0Report Type:Expedited (15-DaCompany Report #US_0501111569 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Zyprexa-Oral Myocardial Infarction (Olanzapine) Pancreatitis (Olanzapine) PS Weight Increased Date:02/09/05ISR Number: 4578289-8Report Type:Expedited (15-DaCompany Report #US_0501111587 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Renal Failure (Olanzapine) (Olanzapine) PS Date:02/09/05ISR Number: 4578294-1Report Type:Expedited (15-DaCompany Report #US_0501111585 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Murmur Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Hypertension (Olanzapine) PS Ketosis Pancreatitis Weight Increased Date:02/09/05ISR Number: 4578299-0Report Type:Expedited (15-DaCompany Report #US_0501111447 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Insulin-Dependent Professional (Olanzapine) PS 5 MG/2 DAY Diabetic Ketoacidosis Lithium C Dyspnoea Benztropine C Facial Palsy Haloperidol C Hypoglycaemia Lotensin (Benazepril Lethargy Hydrochloride) C Nasal Congestion Asa (Acetylsalicylic Pyrexia Acid) C Renal Failure Diphenhydramine C Somnolence Paxil (Paroxetine Tardive Dyskinesia Hydrochloride) C Transient Ischaemic Seroquel (Quetiapine Attack Fumarate) C Date:02/09/05ISR Number: 4578347-8Report Type:Expedited (15-DaCompany Report #US_0502111640 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine / Treatment Noncompliance Professional Fluoxetine (Unknown Company Dose) (Ola PS Representative 24-Jun-2005 12:19 PM Page: 3416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4578468-XReport Type:Expedited (15-DaCompany Report #USA050188423 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Zyprexa-Oral Professional (Olanzapine) PS Date:02/09/05ISR Number: 4578501-5Report Type:Expedited (15-DaCompany Report #US_0502111773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alkalosis Company Zyprexa-Oral(Olanzap Hospitalization - Anoxic Encephalopathy Representative ine) PS 20 MG DAY Initial or Prolonged Blood Creatine Paroxetine C Phosphokinase Mb Acetaminophen Increased W/Hydrocodone C Coagulopathy Oxycodone Diabetes Mellitus Hydrochloride C Diabetic Ketoacidosis Amlodipine Hypernatraemia W/Benazepril C Hyperthermia Hydrocodone C Hypokalaemia Cyclobenzaprine C Hypovolaemic Shock Methylprednisolone C Insomnia Fexofenadine Mental Status Changes Hydrochloride C Renal Failure Minocycline C Respiratory Failure Gabapentin C Rhabdomyolysis Topiramate C Thinking Abnormal Amitripyline C Troponin Increased Date:02/09/05ISR Number: 4579398-XReport Type:Expedited (15-DaCompany Report #USA040978742 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Health Zyprexa-Oral Medication Error Professional (Olanzapine) (Olanzapine) PS 10 MG Date:02/09/05ISR Number: 4579399-1Report Type:Expedited (15-DaCompany Report #USA041184844 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Consumer Zyprexa-Oral Inflammatory Carcinoma Of (Olanzapine) The Breast (Olanzapine) PS 5 MG/ 1 DAY Oestrogen Receptor Assay Zocor (Simvastatin Positive Ratiopharm) C Aricept (Donepezil Hydrochloride) C Zocor (Simvasttin Ratiopharm) C Aricept (Donepezil Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4579400-5Report Type:Expedited (15-DaCompany Report #US_0409105409 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Blood Triglycerides Professional (Olanzapine) PS 10 MG DAY Increased Olanzapine/Fluoxetin Chest Pain e Capsule C Depression Celexa (Citalopram Diabetes Mellitus Hydrobromide) C Non-Insulin-Dependent Anafranil Erectile Dysfunction (Clomipramine Headache Hydrochloride) C Myocardial Infarction Lotrel C Weight Increased Prednisolone C Hydrochlorothiazide C Viagra (Sildenafil Citrate) C Darvocet-N C Aspirin (Acetylsalicylic Acid) C Zyrtec (Cetirizine Hydrochloride) C Nasonex (Mometasone Furoate) C Allegra(Fexofenadine Hydrochloride) C Rabeprazole C Nitroglycerin (Glyceryl Trinitrate) C Propoxiyphene Hcl And Acetaminophen C Date:02/09/05ISR Number: 4579402-9Report Type:Expedited (15-DaCompany Report #US_0408104879 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Consumer Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 15 MG AT Fatigue BEDTIME Headache Zestril (Lisinopril) C Hyperphagia Celexa (Citalopram Impaired Healing Hydrobromide) C Incontinence 'Thimox' C Obesity Celebrex (Celecoxib) C Thirst Singulair Upper Respiratory Tract (Montelukast) C Infection Nexium (Esomeprazole Vision Blurred Magnesium) C Weight Decreased 'Becusate' C Weight Increased Senokot (Senna Alexandrina) C Trazodone C Zyrtec (Cetirizine Hydrochloride) C Hydrochlorothiazide C Atrovent (Ipratropim 24-Jun-2005 12:19 PM Page: 3418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bromide) C Potassium C Vitamin C C Vitamin E (Herbal Oil Nos) C Geodon (Ziprasidone Hydrochloride) C Date:02/09/05ISR Number: 4579403-0Report Type:Expedited (15-DaCompany Report #US_0407104490 Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abdominal Pain Upper Other Adrenal Disorder Amnesia Blood Cholesterol Abnormal Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Pressure Increased Blood Pressure Systolic Increased Blood Triglycerides Increased Blood Urea Decreased Bone Disorder Chest Discomfort Chest Pain Cholelithiasis Condition Aggravated Confusional State Constipation Contusion Diabetes Mellitus Food Craving Generalised Anxiety Disorder Glucose Urine Present Hallucination, Auditory Headache Heart Rate Decreased Hormone Level Abnormal Hypersomnia Hyperventilation Hypoaesthesia Increased Appetite Malaise Mediastinal Disorder Menorrhagia Metrorrhagia Monocyte Percentage Increased Neuropathy Obesity Ovarian Cyst Pain Pancreatitis Panic Attack Paraesthesia 24-Jun-2005 12:19 PM Page: 3419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pco2 Decreased Peptic Ulcer Premenstrual Syndrome Report Source Product Role Manufacturer Route Dose Duration Respiratory Rate Consumer Zyprexa-Oral Increased Health (Olanzapine) Skin Discolouration Professional (Olanzapine) PS 15 MG Somnolence Keflex (Cefalexin Tachycardia Monohydrate) C Tenderness Multivitamins Nos Umbilical Hernia (Multivitamins Nos0 C Urinary Incontinence Geodon (Ziprasidone Urticaria Hydrochloride) C Vaginal Discharge Quetiapine C Vaginal Haemorrhage Risperidone C Vision Blurred Haloperidol C Vomiting Navane (Tiotixene) C Weight Increased Depakote (Valproate White Blood Cell Count Semisodium) C Decreased Bupropion C Celexa (Citalopram Hydrobromide) C Symbyax C Paxil (Paroxetine Hydrochloride) C Venlafaxine C Trazadone (Traodone) C Luvox (Fluvoxamine Maleate) C Insulin C Oral Contraceptive Nos C Lorazepam C Alprazolam C Artane (Trihyexyphenidyl Hydrochloride) C Depo Provera (Medroxyprogesterone Acetate) C Date:02/09/05ISR Number: 4579408-XReport Type:Expedited (15-DaCompany Report #USA040874671 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Consumer Cymbalta (Duloxetine Depression Hydrochloride) PS 60 MG DAY Drug Ineffective Symbyax-Olanzapine 6 Fatigue Mg/ Fluoxetine 50 Mg Headache (Olanzapin SS Hunger Zyprexa-Oral Incontinence (Olanzapine) Malaise (Olanzapine) SS Mood Altered Abilify Nausea (Aripiprazole) C Tardive Dyskinesia Geodon (Ziprasidone) C Weight Increased Klonopin (Clonazepam) C Effexor (Venlafaxine Hydrochloride) C Lamictal 24-Jun-2005 12:19 PM Page: 3420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lamotrigine) C Fluoxetine (Fluoxetine) C Pxybutynin C Calcium C Biotin C Date:02/09/05ISR Number: 4579439-XReport Type:Expedited (15-DaCompany Report #US_0501111542 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Prozac Oral Hospitalization - Ammonia Increased Professional (Fluoxetine Initial or Prolonged Anxiety Company Hydrochloride) PS 40 MG/2 DAY Other Asthenia Representative Zyprexa-Oral Blood Glucose Increased (Olanzapine) Decreased Interest (Olanzapine) SS 2.5 M/1 DAY Delirium Baclofen C Drug Dependence Klonopin Headache (Clonazepam) C Hepatic Encephalopathy Lasix (Furosemide) C Hepatic Failure Premarin C Hepato-Lenticular Imitrex (Sumatriptan Degeneration Succinate) C Hepatotoxicity Prilosec (Omerpazole Herpes Virus Infection Ratiopharm) C Hypertension Atenolol C Hyperventilation Oxycodeone Hydrochl Hypokalaemia W/Oxycodone Incoherent Tareph/Paracet C Insomnia Neurontin International Normalised (Gabapentin Pfizer) C Ratio Increased Lortab C Intervertebral Disc Sudafed Protrusion (Pseudoephedrine Intracranial Pressure Hydrochloride) C Increased Irritability Libido Decreased Major Depression Memory Impairment Nervousness Nitrite Urine Present Overdose Pain Photophobia Respiratory Alkalosis Sepsis Spinal Osteoarthritis Tremor Weight Increased White Blood Cell Count Increased Date:02/09/05ISR Number: 4579464-9Report Type:Expedited (15-DaCompany Report #JP_041004698 Age:68 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 3421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Zyprexa-Oral Increased Literature (Olanzapine) Aspartate Health (Olanzapine) PS 10 MG DAY Aminotransferase Professional Depakene (Valproate Increased Company Sodium) C Blood Lactate Representative Limas (Lithium Dehydrogenase Increased Other Carbonate) C C-Reactive Protein Furosemide Increased (Furosemide) C Erythema Magnesium Oxide C False Positive Laboratory Lendormin Result (Brotizolam) C Hypersensitivity Mucodyne Lymphadenopathy (Carbocisteine) C Photosensitivity Reaction Rash Restlessness White Blood Cell Count Increased Date:02/09/05ISR Number: 4579465-0Report Type:Expedited (15-DaCompany Report #JP_041004822 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Disease Recurrence Professional (Olanzapine) PS 10 MG/1 DAY Electrocardiogram Company Vegetamin A C Abnormal Representative Rohypnol Electrocardiogram Qt Other (Flunitrazepam Eg) C Prolonged Pursennid C Electrocardiogram St-T Risperdal Segment Abnormal (Risperidone) C Excitability Akineton (Biperiden Hallucination, Auditory Lactate) C Insomnia Schizophrenia Date:02/09/05ISR Number: 4579467-4Report Type:Expedited (15-DaCompany Report #JP_050105585 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatocellular Damage Foreign Zyprexa-Oral Hospitalization - Thrombocytopenia Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 2.5 MG DAY Company Depromel Representative (Fluvoxamine) C Other Reslin (Trazodone Hydrochloride) C Amoban (Zopiclone) C Magnesium Oxide C Pursennid C Amicaliq C 24-Jun-2005 12:19 PM Page: 3422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4579468-6Report Type:Expedited (15-DaCompany Report #JP_040102551 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Fibrinogen Foreign Zyprexa-Oral Hospitalization - Increased Literature (Olanzapine) Initial or Prolonged C-Reactive Protein Health (Olanzapine) PS 40 MG DAY Increased Professional Serenace Condition Aggravated Company (Haloperidol) C Deep Vein Thrombosis Representative Lithium Carbonate C Drug Interaction Other Levomepromazine C Fibrin D Dimer Increased Clonazepam C Hyperprolactinaemia Biperiden C Mania Promethazine Prescribed Overdose Hydrochloride C Pulmonary Embolism Magnesium Oxide C Date:02/09/05ISR Number: 4579469-8Report Type:Expedited (15-DaCompany Report #EWC040539350 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Foreign Zyprexa-Rapid-Acting Above Therapeutic Health Im (Olanzapine) PS 10 MG Arrhythmia Professional Tavor (Lorazepam) C Cardiac Arrest Company Talofen (Promazine Cardiac Disorder Representative Hydrochloride) C Condition Aggravated Other Seroquel (Quetiapine Liver Disorder Fumarate) C Mental Disorder Pulmonary Oedema Date:02/09/05ISR Number: 4579484-4Report Type:Expedited (15-DaCompany Report #CA_050107645 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Zyprexa-Oral Other Health (Olanzapine) Professional (Olanzapine) PS Company Paxil (Paroxetine Representative Hydrochloride) C Other Date:02/10/05ISR Number: 4579606-5Report Type:Expedited (15-DaCompany Report #2004AL000535 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Alprazolam Tablets Drug Abuser Health Usp, 2 Mg (Purepac) PS Purepac ORAL PO Drug Toxicity Professional Methadone SS ORAL PO Intentional Misuse Olanzapine SS ORAL PO Venlafaxine SS ORAL PO Date:02/10/05ISR Number: 4579609-0Report Type:Expedited (15-DaCompany Report #2004AL000508 Age:59 YR Gender:Female I/FU:F Outcome Death Hospitalization - 24-Jun-2005 12:19 PM Page: 3423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Acidosis Literature Lorazepam Tablets Analgesic Drug Level Health Usp, 2 Mg (Purepac) PS Purepac ORAL PO Increased Professional Naproxen Aspartate Delayed-Release Aminotransferase Tablets, 500 Mg Increased (Purepac) SS Puepac ORAL PO Blood Creatine Acetaminophen/Tramad Phosphokinase Increased ol SS ORAL PO Blood Potassium Increased Belladonna Coma W/Ergotamine/Phenoba Completed Suicide rbital SS ORAL PO Haemodialysis Losartan SS ORAL PO Hypotension Quinine SS ORAL PO Mental Status Changes Levothyroxine SS ORAL PO Miosis Haloperidol Lactate Multi-Organ Failure Oral Solution Usp, Overdose Eq. 1 Mg Lactate/Ml Renal Failure (Udl) SS Usp ORAL PO Therapeutic Agent Phenytoin Oral Toxicity Suspension Usp, 125 Vomiting Mg/5 Ml (Alpharma) SS Alpharma ORAL PO Sertraline SS ORAL PO Olanzapine SS ORAL PO Hydroxyzine Hydrochloride Syrup Usp, 10 Mg/5 Ml (Alpharma) SS Alparma ORAL PO Date:02/10/05ISR Number: 4579871-4Report Type:Expedited (15-DaCompany Report #2004AL000701 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Literature Trazodone Hospitalization - Blood Pressure Diastolic Health Hydrochloride Initial or Prolonged Decreased Professional Tablets, 100 Mg Blood Pressure Systolic (Purepac) PS Purepac ORAL PO Increased Alprazolam Tablets Brain Oedema Usp, 2 Mg (Purepac) SS Purepac ORAL PO Coma Oxycodone Completed Suicide (Long-Acting) SS ORAL PO General Physical Health Olanzapine SS ORAL PO Deterioration Cyclobenzaprine SS ORAL PO Heart Rate Irregular Gabapentin SS ORAL PO Hypotension Celecoxib SS ORAL PO Hypoxia Intentional Misuse Pupil Fixed Tachycardia Date:02/11/05ISR Number: 4578473-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050200811 Age:53 YR Gender:Male I/FU:I Outcome PT Hospitalization - Atrial Fibrillation Initial or Prolonged Body Temperature Other Increased 24-Jun-2005 12:19 PM Page: 3424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report C-Reactive Protein Increased Cardiac Failure Chronic Report Source Product Role Manufacturer Route Dose Duration Malaise Risperdal PS Myocarditis Euthyrox SS Akineton Ret SS Leponex SS Leponex SS Leponex SS Leponex SS Leponex SS Leponex SS Zyprexa SS Zyprexa SS Zyprexa SS Zyprexa SS Zyprexa SS Tavor SS Tavor SS Tavor SS Tavor SS Date:02/11/05ISR Number: 4582586-XReport Type:Direct Company Report #CTU 240272 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Zyprexa , 20 Mg PS 1 TABL/D/ Hypertension PRECRIBED AND Sudden Death TAKEN DAILY SINCE 6/02 Topamax C Cogentin C Date:02/11/05ISR Number: 4583515-5Report Type:Expedited (15-DaCompany Report #EWC050142404 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Oral Life-Threatening Pulmonary Embolism Health (Olanzapine) Hospitalization - Professional (Olanzapine) PS Initial or Prolonged Other Seroquel (Quetiapine Fumarate) C Orap (Pimozide) C Leponex (Clozapine) C Date:02/14/05ISR Number: 4580802-1Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0513560A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Lamictal PS Glaxosmithkline ORAL 400MG Unknown Tremor Zyprexa SS UNKNOWN Lithium SS Glaxosmithkline UNKNOWN 24-Jun-2005 12:19 PM Page: 3425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/05ISR Number: 4581316-5Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0527287A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Lamictal PS Glaxosmithkline ORAL 100MG Per day Zyprexa SS UNKNOWN Prevacid C Date:02/14/05ISR Number: 4581660-1Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0537094A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Lamictal PS Glaxosmithkline ORAL 150MG Per day 4 WK Cold Sweat Zyprexa SS Diarrhoea Dizziness Drug Ineffective Dry Mouth Influenza Like Illness Insomnia Muscle Fatigue Muscle Spasms Night Sweats Pyrexia Thinking Abnormal Vision Blurred Weight Increased Date:02/14/05ISR Number: 4585443-8Report Type:Expedited (15-DaCompany Report #US_0501111420 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Olanzapine-Oral Initial or Prolonged Hyperhidrosis Professional (Olanzapine) PS 10 MG DAY Mental Status Changes Other Benzotropine Tremor (Benzatropine Mesilate) C Haldol (Haloperidol Decanoate) C Diphenhydramine C Date:02/14/05ISR Number: 4586695-0Report Type:Expedited (15-DaCompany Report #DSA_25766_2005 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Tavor PS ORAL DF ONCE PO Initial or Prolonged Intentional Misuse Health Anafranil - Slow Somnolence Professional Release SS ORAL 1500 MG ONCE Tachycardia Other PO Remergil SS ORAL 1125 MG ONCE PO Zyprexa SS ORAL 100 MG ONCE PO 24-Jun-2005 12:19 PM Page: 3426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/05ISR Number: 4587937-8Report Type:Expedited (15-DaCompany Report #2005024624 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Zoloft (Sertraline) PS ORAL 25 MG (25 MG, Initial or Prolonged Phosphatase Decreased Professional DAILY Disability Dementia INTERVAL Other Fall :EVERY DAY), Hypokalaemia ORAL Metabolic Disorder Olanzapine Musculoskeletal Stiffness (Olanzapine) SS ORAL ORAL Parkinson'S Disease Pioglitazone Pneumonia (Pioglitazone) C Serotonin Syndrome Glibenclamide Tremor (Glibenclamide) C Urinary Retention Tamsulosin Weight Increased Hydrochloride Wheelchair User (Tamsulosin Hydrochloride) C Date:02/15/05ISR Number: 4588486-3Report Type:Direct Company Report #CTU 240472 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyspraxia Zyprexa 5 Mg Hypoaesthesia Lilly PS Lilly ORAL 5 MG QD PRN ORAL Nortriptyline C Neurontin C Buspar C Ibuprofen C Date:02/16/05ISR Number: 4584205-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0365152A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Lamictal PS Glaxosmithkline ORAL Initial or Prolonged Disorientation Floxyfral SS ORAL 50MG Per day 3 DAY Trittico SS ORAL 200MG Per day 3 DAY Zyprexa SS ORAL 5MG Per day 3 DAY Bactrim Forte C Glaxosmithkline ORAL Blopress C ORAL 16MG Per day 3 DAY Date:02/16/05ISR Number: 4588034-8Report Type:Expedited (15-DaCompany Report #DE_050215183 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa Velotab-Oral Medication Error Health (Olanzapine) Professional (Olanzapine) PS 5 MG Other Date:02/16/05ISR Number: 4588036-1Report Type:Expedited (15-DaCompany Report #FR_050205764 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Other Gastrointestinal Foreign Haemorrhage Health 24-Jun-2005 12:19 PM Page: 3427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/1 DAY Date:02/16/05ISR Number: 4588043-9Report Type:Expedited (15-DaCompany Report #GBS050216529 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Neuropathy Foreign Olanzapine-Dispersib Gastric Dilatation Health le (Olanzapine) PS 10 MG DAY Intestinal Dilatation Professional Risperdal Pneumonia Other (Risperidone) C Sepsis Trazodone C Lipostat (Pravastatin Sodium) C Tenormin (Atenolol Eg) C Tritace (Ramipril Dura) C Aspirin (Acetylsalicylic Acid) C Digoxin C Atrovent (Ipratropium Bromide) C Warfarin C Date:02/16/05ISR Number: 4588044-0Report Type:Expedited (15-DaCompany Report #FR_050205765 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Foreign Zyprexa-Oral Haemorrhage Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Company Representative Other Date:02/16/05ISR Number: 4588045-2Report Type:Expedited (15-DaCompany Report #FR_050205766 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Foreign Zyprexa-Oral Haemorrhage Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 3428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4588046-4Report Type:Expedited (15-DaCompany Report #US_0502111747 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sleep Phase Rhythm Foreign Zyprexa-Oral Disturbance Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Company Representative Other Date:02/16/05ISR Number: 4588049-XReport Type:Expedited (15-DaCompany Report #EWC050242500 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Olanzapine-Oral Initial or Prolonged Caesarean Section Health (Olanzapine) PS 5 MG DAY Drug Exposure During Professional Eutirox Pregnancy Other (Levothyroxine) C Hypothyroidism Efexor (Venlafaxine) C Postpartum Disorder Tavor (Lorazepam) C Pre-Eclampsia Lithium C Pregnancy Serum Ferritin Decreased Thrombocythaemia White Blood Cell Count Decreased Date:02/16/05ISR Number: 4588050-6Report Type:Expedited (15-DaCompany Report #DE_050215185 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Zyprexa Velotab-Oral Medication Error Health (Olanzapine) Self-Medication Professional (Olanzapine) PS 5 MG Other Date:02/16/05ISR Number: 4588055-5Report Type:Expedited (15-DaCompany Report #JP_050205812 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Foreign Zyprexa-Oral Epistaxis Consumer (Olanzapine) Weight Increased Other (Olanzapine) PS Date:02/16/05ISR Number: 4588056-7Report Type:Expedited (15-DaCompany Report #JP_050205772 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Zyprexa-Oral Coma Health (Olanzapine) Injury Asphyxiation Professional (Olanzapine) PS 10 MG DAY Vomiting Company Contomin Representative (Chlorpromazine Other Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4588057-9Report Type:Expedited (15-DaCompany Report #JP_050105617 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Foreign Zyprexa-Oral Suicide Attempt Health (Olanzapine) Professional (Olanzapine) PS Company Rohipnol Representative (Flunitrazepam Eg) C Other Date:02/16/05ISR Number: 4588058-0Report Type:Expedited (15-DaCompany Report #GBS050216545 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mental Disorder Foreign Zyprexa-Oral Myocardial Infarction Health (Olanzapine) Professional (Olanzapine) PS Other Date:02/16/05ISR Number: 4588062-2Report Type:Expedited (15-DaCompany Report #JP_040904353 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Foreign Zyprexa-Oral Initial or Prolonged Anorexia Study (Olanzapine) Hallucination, Auditory Health (Olanzapine) PS 10 MG/1 DAY Nausea Professional Selbex (Teprenone) C Psychiatric Symptom Other Dihydergot Soliloquy (Dihydroergotamine Weight Decreased Mesilate) C Effortil (Etilefrine Hydrochloride) C Risumic (Amezinium Metilsulfate) C Somelin (Haloxazolam) C Date:02/16/05ISR Number: 4588063-4Report Type:Expedited (15-DaCompany Report #JP_041004909 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zyprexa-Oral Initial or Prolonged Syndrome Study (Olanzapine) Other Health (Olanzapine) PS 5 MG DAY Professional Lodopin (Zotepine) C Other Cercine (Diazepam) C Halcion (Triazolam) C Depas (Etizolam) C Date:02/16/05ISR Number: 4588064-6Report Type:Expedited (15-DaCompany Report #AU_050108319 Age:45 YR Gender:Male I/FU:F Outcome PT Hospitalization - Adjustment Disorder With Initial or Prolonged Mixed Anxiety And Depressed Mood Alcohol Use 24-Jun-2005 12:19 PM Page: 3430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delirium Hepatic Encephalopathy Toothache Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 30 MG Professional Paracetamol C Company Methadone C Representative Clonazepam C Other Date:02/16/05ISR Number: 4588066-XReport Type:Expedited (15-DaCompany Report #JP_041004822 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Electrocardiogram Qt Professional (Olanzapine) PS 10 MG/1 DAY Prolonged Company Vegetamin A C Electrocardiogram St-T Representative Rohypnol Segment Abnormal Other (Flunitrazepam Eg) C Electrocardiogram T Wave Pursennid C Inversion Risperdal Excitability (Risperidone) C Hallucination, Auditory Akineton (Biperiden Insomnia Lactate) C Date:02/16/05ISR Number: 4588069-5Report Type:Expedited (15-DaCompany Report #FR_050205751 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa Initial or Prolonged Alanine Aminotransferase Health (Olanzapine) PS ORAL 20 MG/1 DAY Increased Professional Xanax Aspartate Other (Alprazolam Dum) C Aminotransferase Imovane Increased (Zopiclone) C Blood Alkaline Spironolactone Phosphatase Increased Dysphagia (Spironolactone) C Epilepsy Fall Gamma-Glutamyltransferase Increased Hypokalaemia Hyponatraemia Inflammation Pneumonitis Somnolence Date:02/16/05ISR Number: 4588070-1Report Type:Expedited (15-DaCompany Report #DE_050215186 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Foreign Zyprexa Health (Olanzapine) PS ORAL 2.5 MG IN THE Professional EVENING Other Nexium (Esomeprazole 24-Jun-2005 12:19 PM Page: 3431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Magnesium) C Lasix (Furosemide) C Cosopt C Date:02/16/05ISR Number: 4588078-6Report Type:Expedited (15-DaCompany Report #FR_050105704 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Zyprexa Initial or Prolonged Oxygen Saturation Health Decreased Professional (Olanzapine) PS ORAL Respiratory Failure Other Date:02/16/05ISR Number: 4588081-6Report Type:Expedited (15-DaCompany Report #CA_050207717 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine Other (Olanzapine) PS ORAL Accutane (Isotretinoin Mepha) C Date:02/16/05ISR Number: 4588087-7Report Type:Expedited (15-DaCompany Report #EWC040940724 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Olanzapine Electrocardiogram Qt Health (Olanzapine) PS ORAL 10 MG Prolonged Professional Company Representative Other Date:02/16/05ISR Number: 4588089-0Report Type:Expedited (15-DaCompany Report #GBS050116380 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening No Adverse Effect Foreign Olanzapine Hospitalization - Health (Olanzapine) PS ORAL 20 MG Initial or Prolonged Professional Haloperidol C Other Company Representative Other Date:02/16/05ISR Number: 4588090-7Report Type:Expedited (15-DaCompany Report #EWC050142158 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Olanzapine Initial or Prolonged Drug Screen Positive Health (Olanzapine) PS ORAL Respiratory Failure Professional Benzodiazepine C Suicide Attempt Company Lithium C Representative Serotoninergic Drug Other Nos C 24-Jun-2005 12:19 PM Page: 3432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4588095-6Report Type:Expedited (15-DaCompany Report #EWC041241993 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Olanzapine (Depot) PS 405 MG OTHER Initial or Prolonged Difficulty In Walking Study Fluanxol Dizziness Health (Flupentixol Dyskinesia Professional Decanoate) C Extensor Plantar Response Other Heart Rate Increased Hyporeflexia Laboratory Test Abnormal Miosis Sedation Somnolence Speech Disorder Unresponsive To Pain Stimuli Unresponsive To Verbal Stimuli Date:02/16/05ISR Number: 4588334-1Report Type:Expedited (15-DaCompany Report #DSA_25800_2005 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Temesta PS ORAL 1 MG Q DAY PO Initial or Prolonged Confusional State Health Allopurinol SS ORAL 100 MG Q DAY Disorientation Professional PO Electroencephalogram Other Plavix SS ORAL 75 MG Q DAY Abnormal PO Encephalopathy Zyprexa SS ORAL 5 MG Q DAY PO Hallucination, Visual Imovane C Hyperreflexia Zocor C Myoclonus Date:02/16/05ISR Number: 4588410-3Report Type:Expedited (15-DaCompany Report #US_0411108016 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Zyprexa-Oral Initial or Prolonged Condition Aggravated (Olanzapine) Decreased Appetite (Olanzapine) PS 20 MG Depression Lamotrigine C Diabetes Mellitus Escitalopram C Diarrhoea Ferrous Sulfate Electroencephalogram (Ferrous Sulfate) C Abnormal Diphenhydramine C Excoriation Lithium Carbonate Feeling Guilty (Lithium Carbonate) C Hallucination Quetiapine C Influenza Like Illness Risperidone C Intentional Self-Injury Iron Deficiency Anaemia Pharyngitis Suicidal Ideation Upper Respiratory Tract Infection Vision Blurred 24-Jun-2005 12:19 PM Page: 3433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4588735-1Report Type:Expedited (15-DaCompany Report #US_0501111447 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Blood Creatine Professional (Olanzapine) PS 30 MG/ DAY Phosphokinase Increased Lithium C Blood Pressure Systolic Benztropine C Increased Haloperidol C Blood Triglycerides Lotensin (Benazepril Increased Hydrochloride) C Body Temperature Asa (Acetylsalicylic Increased Acid) C Dehydration Diphenhydramine C Depressed Level Of Paxil (Paroxetine Consciousness Hydrochloride) C Diabetes Mellitus Seroquel (Quetiapine Insulin-Dependent Fumarate) C Diabetic Ketoacidosis Influenza Vaccine C Dilatation Atrial Dysarthria Dyspnoea Facial Palsy Facial Paresis Hypoglycaemia Lethargy Nasal Congestion Nausea Pyrexia Renal Failure Respiratory Rate Increased Sinus Tachycardia Somnolence Tardive Dyskinesia Transient Ischaemic Attack Urinary Retention Vomiting Date:02/16/05ISR Number: 4588736-3Report Type:Expedited (15-DaCompany Report #US_0412109449 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Olanzapine-Oral Initial or Prolonged Akathisia Health (Olanzapine) PS Dyskinesia Professional Bifeprunox SS Insomnia Lorazepam C Irritability Psychotic Disorder Date:02/16/05ISR Number: 4588740-5Report Type:Expedited (15-DaCompany Report #US_0406103668 Age:49 YR Gender:Female I/FU:F Outcome PT Anxiety Asthenia Blood Glucose Fluctuation Blood Potassium Decreased 24-Jun-2005 12:19 PM Page: 3434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Pressure Increased Blood Sodium Decreased Condition Aggravated Report Source Product Role Manufacturer Route Dose Duration Constipation Consumer Zyprexa-Oral Dehydration Health (Olanzapine) Depression Professional (Olanzapine) PS 20 MG DAY Diabetes Mellitus Glucotrol Flatulence (Glipizide) C Haemorrhoids Penta-Triamterene Headache Hctz C Hypertriglyceridaemia Nexium (Esomeprazole Ill-Defined Disorder Magnesium) C Irritability Premarin C Libido Increased Synthroid Logorrhoea (Levothyroxine Mania Sodium) C Muscle Spasms Tricor (Fenofibrate) C Pain In Extremity Risperidone C Pressure Of Speech Aripiprazole C Rectal Haemorrhage Haldol (Haloperidol Somnolence Decanoate) C Thinking Abnormal Lithium C Tooth Extraction Lorazepam C Vision Blurred Restoril (Temazepam) C Weight Decreased Ambien (Zolpidem Tartrate) C Hydrocodone W/Apap C Penicillin Vk (Phenoxymethylpenici llin Potassium) C Relafen (Nabumetone) C Trazadone (Trazodone) C Ibuprofen (Ibuprofen) C Influenza Vaccine C Remeron (Mirtazapine Orifarm) C Bextra (Valdecoxib) C Naprosyn (Naproxen Mepha) C Quinine C Maxzide C Clonidine C Date:02/16/05ISR Number: 4588752-1Report Type:Expedited (15-DaCompany Report #US_0408104879 Age:41 YR Gender:Female I/FU:F Outcome PT Hospitalization - Asthma Initial or Prolonged Bronchitis Diabetes Mellitus Ear Pain Fatigue Headache Hyperphagia Hypoaesthesia Impaired Healing Incontinence Lipase Increased 24-Jun-2005 12:19 PM Page: 3435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Paraesthesia Pharyngitis Streptococcal Report Source Product Role Manufacturer Route Dose Duration Vomiting Consumer Zyprexa-Oral Weight Decreased Health (Olanzapine) Weight Increased Professional (Olanzapine) PS 15 MG AT BEDTIME Zestril (Lisinopril) C Celexa (Citalopram Hydrobromide) C Celebrex (Celecoxib) C Singulair (Montelukast) C Nexium (Esomeprazole Magnesium) C Senokot (Senna Alexandrina) C Trazodone C Zyrtec (Cetirizine Hydrochloride) C Hydrochlorothiazide C Atrovent (Ipratropium Bromide) C Potassium C Vitamin C C Vitamin E (Herbal Oil Nos) C Geodon (Ziprasidone Hydrochloride) C Albuterol C Advair C Flonase (Fluticasone Propionate) C Ibuprofen (Ibuprofen) C Hydrocortisone, Topical C Cyclobenzaprine C Desonide C Clotrimazole C Multivitamin C Benzonatate C Acular (Ketorolac Tromethamine) C Citrucel (Methylcellulose) C Docusate C Lotrisone C Hydralazine C Date:02/16/05ISR Number: 4588775-2Report Type:Expedited (15-DaCompany Report #USA040978382 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Health Zyprexa Oral Professional (Olanzapine)(Olanzap Company ine) PS Representative 24-Jun-2005 12:19 PM Page: 3436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4588779-XReport Type:Expedited (15-DaCompany Report #USA041081281 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Zyprexa Oral Prescribed Overdose Professional (Olanzapine)(Olanzap Sedation Company ine) PS 30 MG Representative Klonopin (Clonazepam) C Neurontin (Gabapentin Pfizer) C Desyrel (Trazodone Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:02/16/05ISR Number: 4588816-2Report Type:Expedited (15-DaCompany Report #US_0410106363 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Blood Cholesterol Health (Olanzapine) Other Abnormal Professional (Olanzapine) PS 20 MG Blood Triglycerides Depakote (Valproate Increased Semisodium) C Constipation Depakene (Valproate Cough Semisodium) C Dehydration Zoloft (Sertraline Dental Discomfort Hydrochloride) C Diabetes Mellitus Synthroid Gingivitis (Levothyroxine Hepatitis C Sodium) C Hepatitis Viral Beclomethasone C Herpes Zoster Influenza Vaccine C Hyperglycaemic Hyperosmolar Nonketotic Syndrome Hypoaesthesia Hypothyroidism Increased Appetite Obesity Pain Periodontal Operation Rash Upper Respiratory Tract Infection Weight Decreased Date:02/16/05ISR Number: 4588917-9Report Type:Expedited (15-DaCompany Report #US_0502112020 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Hypertension (Olanzapine) Prescribed Overdose (Olanzapine) PS 20 MG/2 DAY Symbyax-Olanzapine / Fluoxetine (Ola SS Zoloft (Sertraline Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept (Donepezil Hydrochloride) C Glucotrol (Glipizide) C Date:02/16/05ISR Number: 4588919-2Report Type:Expedited (15-DaCompany Report #USA050189378 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Zyprexa-Oral Other Cerebrovascular Disorder Professional (Olanzapine) Coma Company (Olanzapine) PS 5 MG/ 1 DAY Haemorrhage Representative Neurontin (Gabapentin Pfizer) C Date:02/16/05ISR Number: 4588921-0Report Type:Expedited (15-DaCompany Report #USA050189482 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine) Other Drug Ineffective (Olanzapine) PS 40 MG DAY Loss Of Consciousness Restoril (Temazepam) C Overdose Bextra (Valdecoxib) C Pneumonia Parnate Prescribed Overdose (Tranylcypromine) C Restlessness Suicide Attempt Weight Decreased Date:02/16/05ISR Number: 4588923-4Report Type:Expedited (15-DaCompany Report #USA050189483 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Personality Disorder Health Zyprexa-Oral Unevaluable Event Professional (Olanzapine) Company (Olanzapine) PS 10 MG DAY Representative Lexapro (Escitalopram Oxalate) C Xanax (Alprazolam Dum) C Oxycontin (Oxycodone Hydrochloride) C Trazodone C Date:02/16/05ISR Number: 4588926-XReport Type:Expedited (15-DaCompany Report #USA050289604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG DAY Representative 24-Jun-2005 12:19 PM Page: 3438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4588928-3Report Type:Expedited (15-DaCompany Report #USA050289727 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS Date:02/16/05ISR Number: 4588931-3Report Type:Expedited (15-DaCompany Report #USA050289735 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Zyprexa-Dispersible Other Company (Olanzapine) Representative (Olanzapine) PS Date:02/16/05ISR Number: 4588933-7Report Type:Expedited (15-DaCompany Report #US_0501111227 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Zyprexa-Oral Breast Mass Health (Olanzapine) Breast Tenderness Professional (Olanzapine) PS 20 MG DAY Chest Pain Prozac (Fluoxetine Cough Hydrochloride) C Diabetes Mellitus Neurontin Non-Insulin-Dependent (Gabapentin Pfizer) C Disturbance In Attention Clonapin Dyspnoea (Clonazepam) C Ear Pain Celexa (Citalopram Enuresis Hydrobromide) C Fatigue Wellbutrin Sr Gastrooesophageal Reflux (Bupropion) C Disease Ambien (Zolpidem Hallucination Tartate) C Intervertebral Disc Lithium C Protrusion Oesophagitis Paraesthesia Restless Legs Syndrome Suicidal Ideation Treatment Noncompliance Weight Increased Date:02/16/05ISR Number: 4588941-6Report Type:Expedited (15-DaCompany Report #USA050189513 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Olanzapine-Rapid-Act Professional ing Im PS 10 MG Company Depakoate (Valproate Representative Semisodium) C Geodon (Ziprasidone Hydrochloride) C Lithium C Metformin C Klonopin (Clonazepam) C 24-Jun-2005 12:19 PM Page: 3439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4588944-1Report Type:Expedited (15-DaCompany Report #US_0411108017 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Symbyak-Olanzapine Cerebrovascular Accident Health 6mg / Fluoxetine Contusion Professional 50mg (Olanzapin PS Convulsion Company Xanax (Alprazolam Fall Representative Dum) C Fatigue Irritability Trismus Date:02/16/05ISR Number: 4588950-7Report Type:Expedited (15-DaCompany Report #US_0502111691 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Literature Zyprexa-Oral Initial or Prolonged Aggression Health (Olanzapine) Body Mass Index Increased Professional (Olanzapine) PS 2.5 MG/1 AT Decreased Appetite BEDTIME 9 MON Diabetes Mellitus Valproic Acid C Glucose Urine Present Guanfacine C Glycosylated Haemoglobin Amphetamine Salts C Increased Hyperglycaemia Lethargy Nocturia Urine Ketone Body Present Weight Increased Date:02/16/05ISR Number: 4589363-4Report Type:Expedited (15-DaCompany Report #B0349817A Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Wellbutrin Completed Suicide Health Unspecified Tablet Toxicologic Test Abnormal Professional (Bupropion Hydrochloride) PS ORAL ORAL Topiramate (Topiramate) SS ORAL ORAL Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Date:02/16/05ISR Number: 4589393-2Report Type:Expedited (15-DaCompany Report #US_010668260 Age:39 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anal Discomfort Initial or Prolonged Asthenia Other Balanitis Blood Chloride Decreased Blood Cholesterol Increased Blood Potassium Increased 24-Jun-2005 12:19 PM Page: 3440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Sodium Decreased Blood Triglycerides Increased Report Source Product Role Manufacturer Route Dose Duration Bronchitis Consumer Zyprexa-Oral Burning Sensation Health (Olanzapine) Condition Aggravated Professional (Olanzapine) PS 20 MG/1 DAY Conjunctival Hyperaemia Abilify Culture Throat Positive (Aripiprazole) C Diabetes Mellitus Seroquel (Quetiapine Diabetes Mellitus Fumarate) C Inadequate Control Risperdal Diabetic Neuropathy (Risperidone) C Diarrhoea Geodon (Ziprasidone Dizziness Hydrochloride) C Dysphoria Thorazine Electrocardiogram St (Chlorpromazine Segment Elevation Hydrochloride) C Erectile Dysfunction Haldol (Haloperidol Erythema Decanoate) C Fatigue Trilafon Gastritis (Perphenazine Gastrooesophageal Reflux Enantate) C Disease Navane (Tiotixene) C Haematemesis Wellbutrin Haematochezia (Bupropion Headache Hydrochloride) C Hepatic Steatosis Remeron (Mirtazapine Hepatitis C Orifarm) C High Density Lipoprotein Zoloft (Sertraline Decreased Hydrochloride) C Hyperglycaemia Effexor (Venlafaxine Hypogonadism Hydrochloride) C Lung Infiltration Glucotrol Myocardial Infarction (Glipizide) C Nasal Congestion Metaglip C Nephrolithiasis Glucophage Obesity (Metformin) C Opiates Positive Prevacid Otitis Media (Lansoprazole) C Pco2 Decreased Buspar (Buspirone Presbyopia Hydrochloride) C Reflux Oesophagitis Retching Schizoaffective Disorder Sleep Apnoea Syndrome Sneezing Suicidal Ideation Throat Irritation Vision Blurred Vomiting Weight Increased Date:02/16/05ISR Number: 4589449-4Report Type:Expedited (15-DaCompany Report #EWC050242476 Age: Gender:Female I/FU:I Outcome PT Report Source Metrorrhagia Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 3441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS 10 MG Oral Contraceptive Nos C Date:02/16/05ISR Number: 4589516-5Report Type:Expedited (15-DaCompany Report #USA041183446 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Dispersible Initial or Prolonged Blood Cholesterol Professional (Olanzapine) Other Increased (Olanzapine) PS 15 MG/1 DAY Delusion Zocor (Simvastatin) C Diabetes Mellitus Vitamin E (Herbal Diet Refusal Oil Nos) C Dyslipidaemia Hostility Hypertriglyceridaemia Logorrhoea Low Density Lipoprotein Increased Mental Impairment Obesity Total Cholesterol/Hdl Ratio Increased Treatment Noncompliance Weight Decreased Weight Increased Date:02/16/05ISR Number: 4589523-2Report Type:Expedited (15-DaCompany Report #US_0502111673 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Extrapyramidal Disorder (Olanzapine) PS Hypertension Myocardial Infarction Pancreatitis Weight Increased Date:02/16/05ISR Number: 4589533-5Report Type:Expedited (15-DaCompany Report #US_0502111708 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Hypertension (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4589538-4Report Type:Expedited (15-DaCompany Report #US_0502111706 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Extrapyramidal Disorder (Olanzapine) Hypertension (Olanzapine) PS Renal Disorder Weight Increased Date:02/17/05ISR Number: 4585979-XReport Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0290018-00 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Akineton Retard PS ORAL 26 DAY Initial or Prolonged Body Temperature Levothyroxine Sodium SS ORAL 49 DAY Increased Risperidone SS ORAL 31 DAY C-Reactive Protein Leponex SS ORAL Increased Leponex SS ORAL Cardiac Failure Leponex SS ORAL Fatigue Leponex SS ORAL Myocarditis Leponex SS ORAL Leponex SS ORAL Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Lorazepam SS ORAL Lorazepam SS ORAL Lorazepam SS ORAL Lorazepam SS ORAL Date:02/17/05ISR Number: 4590258-0Report Type:Expedited (15-DaCompany Report #6012941 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Euthyrox Initial or Prolonged C-Reactive Protein Health Increased Professional (Levothyroxine Cardiac Failure Other Sodium) PS ORAL 100 MG ORAL 50 DAY Myocarditis Risperdal (Risperidone) SS 4 MG Akineton Ret (Biperiden Hydrochloride) SS ORAL 1 DOSE FORMS ORAL 26 DAY Leponex (Clozapine) SS SEE IMAGE 1 DAY Zyprexa (Olanzapine) SS SEE IMAGE 15 DAY Tavor (Lorazepam) SS SEE IMAGE 21 DAY Date:02/17/05ISR Number: 4604467-5Report Type:Periodic Company Report #S04-USA-07565-01 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Anorexia Health Nausea Professional 24-Jun-2005 12:19 PM Page: 3443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Namenda (Memantine) PS ORAL 10 MG QD PO Namenda (Memantine) SS ORAL 5 MG QD PO Zyprexa (Olanzapine) SS Risperdal (Risperidone) SS Date:02/18/05ISR Number: 4586712-8Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0290023-00 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Akineton PS ORAL 7 MON Initial or Prolonged Faecaloma Flupentixol Ileus Dihydrochloride SS ORAL Subileus Flupentixol Dihydrochloride SS ORAL Loponex SS ORAL Loponex SS ORAL Loponex SS ORAL 50-175 mg daily Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Melperone Hydrochloride C ORAL Date:02/18/05ISR Number: 4587262-5Report Type:Expedited (15-DaCompany Report #SE-GLAXOSMITHKLINE-B0371992A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Seroxat PS Glaxosmithkline Living Impaired Seroscand SS Eating Disorder Zyprexa SS Intentional Self-Injury Imovane C Laceration Sonata C Sensation Of Blood Flow Stesolid C Sleep Disorder Atarax C Stress Tension Date:02/18/05ISR Number: 4592609-XReport Type:Expedited (15-DaCompany Report #2005-125006-NL Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Mirtazapine PS ORAL 30 MG QD ORAL Professional Olanzapine SS ORAL 6 MG QD ORAL 136 DAY Date:02/21/05ISR Number: 4588246-3Report Type:Expedited (15-DaCompany Report #AT-ABBOTT-05P-009-0290364-00 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Depakine Chrono PS ORAL Initial or Prolonged Olanzapine SS ORAL 24-Jun-2005 12:19 PM Page: 3444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine SS ORAL Zolpidem C ORAL 41 DAY Date:02/22/05ISR Number: 4588741-7Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12856845 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Compartment Syndrome Pharmaceutical Insomnia Company, Ltd. 15 mg Negative Thoughts 29-Oct-04 to Restlessness 03-Dec-04; 30 Suicide Attempt mg 03-Dec-04 to 09-Dec-04 42 DAY Olanzapine SS 'till 15-Nov-04 5 mg; then 15-Nov-04 to 22-Nov-04, Oxazepam SS Date:02/22/05ISR Number: 4590979-XReport Type:Direct Company Report #CTU 240871 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Zyprexa 10 Mg Bid PS ORAL 10 MG PO BID Initial or Prolonged Prozac 80 Mg Daily SS ORAL 20 MG AM , 60 MG HS PO Zantac C Prilosec C Atenolol C Penergan C Date:02/22/05ISR Number: 4591237-XReport Type:Expedited (15-DaCompany Report #DSA_25855_2005 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Foreign Tavor PS ORAL 10 MG ONCE PO Initial or Prolonged Intentional Misuse Health Anafranil SS ORAL 5175 MG ONCE Myoclonus Professional PO Somnolence Other Delix SS ORAL DF ONCE PO Detrusitol SS ORAL DF ONCE PO Ergenyl Chrono SS ORAL DROPPERFUL ONCE PO Stangyl SS ORAL DF ONCE PO Zyprexa SS ORAL 15 MG ONCE PO Date:02/22/05ISR Number: 4591540-3Report Type:Expedited (15-DaCompany Report #2005026860 Age:70 YR Gender:Female I/FU:I Outcome PT Disability Agitation Alanine Aminotransferase Increased Aspartate Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 3445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Alkaline Phosphatase Increased Blood Creatinine Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Xanax Tablet Depressed Level Of Health (Alprazolam) PS 0.2 MG (0.2 Consciousness Professional MG, 1 IN 1 Dyskinesia D), ORAL Fall Zopiclone Gamma-Glutamyltransferase (Zopiclone) SS ORAL ORAL Increased Spironolacton Hypokalaemia (Spironolactone) SS ORAL Hyponatraemia Olanzapine Malaise (Olanzapine) SS ORAL 20 ML (20 M, Pneumonia Aspiration 1 IN 1 D), Somnolence ORAL Status Epilepticus Date:02/23/05ISR Number: 4589665-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-395215 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Valium PS Roche ORAL 16 DAY Initial or Prolonged Encephalopathy Depakote SS ORAL 9 DAY Fall Zyprexa SS ORAL 7 DAY Hypotonia Imovane SS ORAL 19 DAY Mania Deroxat C ORAL 5 DAY Sedation Tercian C 3 DAY Date:02/23/05ISR Number: 4589817-0Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045937A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastroenteritis Sostril PS Glaxosmithkline ORAL 300MG per day 22 DAY Hepatic Enzyme Increased Zyprexa SS UNKNOWN 22 DAY Nausea Dipiperon SS UNKNOWN 40MG per day 10 DAY Tavor C UNKNOWN 2MG per day 15 DAY Date:02/24/05ISR Number: 4590289-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE01017 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Ludiomil PS Novartis Sector: Pain In Extremity Pharma ORAL 150mg/day 48960MIN Parkinsonian Gait Solian SS ORAL 200 mg, QD 11520MIN Parkinsonism Solian SS ORAL 100 mg, QD 4320 MIN Sensation Of Heaviness Zyprexa SS ORAL 5 mg, QD 10080MIN Tremor Akineton C ORAL 4mg/day 216 DAY Atosil C ORAL 75mg/day 218 DAY Beloc-Zok C ORAL 1 to 2 df/day 18720MIN Date:02/24/05ISR Number: 4590406-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Acute Risperdal PS OROPHARINGEAL Hospitalization - Neuroleptic Malignant Risperdal SS OROPHARINGEAL Initial or Prolonged Syndrome Halomonth SS 24-Jun-2005 12:19 PM Page: 3446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine SS OROPHARINGEAL Olanzapine SS OROPHARINGEAL Cimetidine C Biperiden Hydrochloride C Isoleucine Leucine Valine C Flunitrazepam C Zopiclone C Sennoside C Aspartate Potassium C Date:02/24/05ISR Number: 4590577-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0370903A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Lithium PS Glaxosmithkline UNKNOWN 500MG per day Cardiac Disorder Olanzapine SS UNKNOWN 20MG per day Mitral Valve Prolapse Levomepromazine SS UNKNOWN 200MG per day Sudden Death Tropatepine SS UNKNOWN 10MG per day Ventricular Hypertrophy Clomipramine SS UNKNOWN 75MG per day Date:02/24/05ISR Number: 4595128-XReport Type:Expedited (15-DaCompany Report #GXKR2004US00750 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Literature Mirtazapine (Ngx) Initial or Prolonged Serotonin Syndrome Health (Mirtazapine) PS 45 MG, QD, Professional Olanzapine (Ngx) (Olanzapine) SS 10 MG, QD, 8 DAY Tramadol (Tramadol) SS 150 MG, QD, Date:02/24/05ISR Number: 4595382-4Report Type:Expedited (15-DaCompany Report #USA041080785 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Consumer Zyprexa Increased Feeling Abnormal (Olanzapine) PS ORAL 15 MG DAY Myocardial Infarction Areicept (Donepezil Hydrochloride) C Namenda (Memantine Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Vitamin E C Multivitamin C Aspirin Enteric Coated K.P. (Acetylsalicylic Acid) C Toprol Xl (Metoprolol Succinate) C Imdur (Isosorbide Mononitrate) C 24-Jun-2005 12:19 PM Page: 3447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4595389-7Report Type:Expedited (15-DaCompany Report #USA050289691 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Zyprexa-Oral Cardiac Arrest Professional (Olanzapine) Lethargy (Olanzapine) PS 45 MG Medication Error Tachycardia Date:02/24/05ISR Number: 4595390-3Report Type:Expedited (15-DaCompany Report #US_0406103675 Age:49 YR Gender:Female I/FU:I Outcome PT Hospitalization - Acne Initial or Prolonged Alanine Aminotransferase Other Increased Ammonia Increased Amnesia Anger Anxiety Aspartate Aminotransferase Increased Binge Eating Blood Albumin Decreased Blood Glucose Increased Blood Thyroid Stimulating Hormone Decreased Condition Aggravated Contusion Cystitis Klebsiella Depressed Level Of Consciousness Depression Diabetes Mellitus Non-Insulin-Dependent Disturbance In Attention Diverticulitis Dizziness Drug Abuser Dysuria Eye Disorder Fall Fatigue Fear Flat Affect Formication Gamma-Glutamyltransferase Increased Hallucination, Auditory Headache Hypercholesterolaemia Hypotension Insomnia Loss Of Consciousness Micturition Urgency Muscle Spasms Muscle Twitching Nightmare Panic Disorder 24-Jun-2005 12:19 PM Page: 3448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Polysubstance Abuse Prescribed Overdose Report Source Product Role Manufacturer Route Dose Duration Self Mutilation Consumer Zyprexa Self-Medication Health (Olanzapine) PS ORAL 45 MG AT Sexual Abuse Professional BEDTIME Suicidal Ideation Abilify Syncope (Aripirazole) C Tangentiality Wellbutrin Sr Thermal Burn (Bupropion Tremor Hydrochloride) C Vulvovaginal Discomfort Paxil (Paroxetine Weight Increased Hydrochloride) C Antabuse (Disulfiram) C Spironolactone (Spironolactone) C Lithium Carbonate C Lisinopril (Lisinopril) C Atorvastatin C Metformin C Risperdal (Risperidone) C Vitamin B12 C Zantac (Ranitidine Hydrochloride) C Bactrim Ds C Erythromycin (Erythromycin) C Vistaril (Hydroxyzine Embonate) C Tetracycline C Clonidine C Nicotine Dermal Patch (Nicotine Resin) C Thiamine C Multivitamin C Mylanta C Milk Of Magnesia C Cleocin T (Clindamycin Phosphate) C Artane (Trihexyphenidyl Hydrochloride) C Dulcolax (Bisacodyl) C Diphenhydramine C Neomycin C Levaquin (Levofloxacin) C Date:02/24/05ISR Number: 4595392-7Report Type:Expedited (15-DaCompany Report #US_0502112163 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Consumer Zyprexa-Oral Other (Olanzapine) 24-Jun-2005 12:19 PM Page: 3449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) PS Date:02/24/05ISR Number: 4595406-4Report Type:Expedited (15-DaCompany Report #USA050187444 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bladder Disorder Consumer Symbyax-Olanzapine Convulsion Company 6mg / Fluoxetine Cyanosis Representative 25mg (Olanzapin PS Fall Foaming At Mouth Gastrointestinal Disorder Infection Loss Of Consciousness Memory Impairment Muscle Twitching Somnolence Tonic Clonic Movements Tremor Date:02/24/05ISR Number: 4595431-3Report Type:Expedited (15-DaCompany Report #US_0407104132 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Zyprexa-Oral Initial or Prolonged Back Pain (Olanzapine) Other Blood Cholesterol (Olanzapine) PS Increased Lopid (Gemfibrozil) C Blood Triglycerides Trazadone Increased (Trazodone) C Deafness Lipitor Diabetes Mellitus (Atorvastatin Ear Pain Calcium) C Fall Paxil (Paroxetine Haemorrhoids Hydrochloride) C Headache Hyperlipidaemia Nephrolithiasis Obesity Pancreatitis Protein Urine Present Red Blood Cells Urine Positive Renal Colic White Blood Cells Urine Positive Date:02/24/05ISR Number: 4595443-XReport Type:Expedited (15-DaCompany Report #US_0501110055 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Injury Asphyxiation Professional (Olanzapine) Company (Olanzapine) PS 5 MG AT Representative BEDTIME Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 60 MG/1 DAY 24-Jun-2005 12:19 PM Page: 3450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft (Sertraline Hydrochloride) C Date:02/24/05ISR Number: 4595444-1Report Type:Expedited (15-DaCompany Report #US_020988011 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Literature Zyprexa-Oral Hospitalization - Arrhythmia Health (Olanzapine) Initial or Prolonged Atrial Fibrillation Professional (Olanzapine) PS 750 MG OTHER Other Blood Creatinine Lithium C Increased Terazosin C Blood Lactic Acid Rabeprazole C Increased Methocarbamol C Cardiac Arrest Thiamine C Cardiac Failure Ibuprofen C Congestive Cerebral Atrophy Choreoathetosis Coma Confusional State Contusion Coordination Abnormal Decerebration Delirium Dysarthria Dystonia Extensor Plantar Response Gait Disturbance Grimacing Haemorrhage Subcutaneous Head Banging Hyperreflexia Hypotonia Lethargy Metabolic Acidosis Myoclonus Nystagmus Overdose Pathogen Resistance Pneumonia Prescribed Overdose Restlessness Rhabdomyolysis Saliva Altered Sepsis Skin Infection Somnolence Speech Disorder Status Epilepticus Suicide Attempt Ventricular Tachycardia White Blood Cell Count Increased Wound Infection 24-Jun-2005 12:19 PM Page: 3451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4595446-5Report Type:Expedited (15-DaCompany Report #US_0501110892 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Myocardial Infarction (Olanzapine) Weight Increased (Olanzapine) PS 58 MON Date:02/24/05ISR Number: 4595447-7Report Type:Expedited (15-DaCompany Report #US_0502112041 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:02/24/05ISR Number: 4595449-0Report Type:Expedited (15-DaCompany Report #US_0502112165 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Extrapyramidal Disorder (Olanzapine) Hypertension (Olanzapine) PS Ketosis Myocardial Infarction Pancreatitis Weight Increased Date:02/24/05ISR Number: 4595450-7Report Type:Expedited (15-DaCompany Report #US_0501110115 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Emphysema (Olanzapine) Extrapyramidal Disorder (Olanzapine) PS Gingival Disorder Hypertension Weight Increased Date:02/24/05ISR Number: 4595457-XReport Type:Expedited (15-DaCompany Report #US_0406103668 Age:52 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Anxiety Apathy Asthenia Bipolar Disorder Blood Cholesterol Increased Blood Glucose Fluctuation Blood Glucose Increased Blood Potassium Decreased Blood Pressure Increased Blood Sodium Decreased Blood Triglycerides Increased Bursitis 24-Jun-2005 12:19 PM Page: 3452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Constipation Crying Report Source Product Role Manufacturer Route Dose Duration Dehydration Consumer Zyprexa-Oral Depression Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 20 MG DAY Flatulence Glucotrol Flight Of Ideas (Glipizide) C Gastrooesophageal Reflux Penta-Triamterene Disease Hctz C Glycosylated Haemoglobin Nexium Increased (Esomeoprazole Haematochezia Magnesium) C Haemorrhoids Premarin C Headache Synthroid Hypersomnia (Levothyroxine Hypertriglyceridaemia Sodium) C Irritability Tricor (Fenofibrate) C Libido Increased Risperidone C Logorrhoea Aripiprazole C Mania Haldol (Haloperidol Night Cramps Decanoate) C Pain In Extremity Lithium C Pressure Of Speech Lorazepam C Rectal Haemorrhage Restoril (Temazepam) C Sleep Disorder Ambien (Zolpidem Thinking Abnormal Tartrate) C Vision Blurred Hydrocodone W/Apap C Weight Decreased Penicillin Vk (Phenoxymethylpenici llin Potassium) C Relafen (Nabumetone) C Trazadone (Trazodone) C Ibuprofen (Ibuprofen) C Influenza Vaccine C Remeron (Mirtazapine Orifarm) C Bextra (Valdecoxib) C Naprosyn (Naproxen Mepha) C Quinine C Maxzide C Clonidine C Lamotrigine C Quetiapine C Pantoprazole C Novane C Prevacid C Maalox Plus C Acetaminophen C Milk Of Magnesia C Nicotine C Hydroxyzine C Lamictal (Lamotrigine) C Pepcid (Famotidine) C Seroquel (Quetiapine Fumarate) C Protonix 24-Jun-2005 12:19 PM Page: 3453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pantoprazole) C Diphenhydramine C Date:02/24/05ISR Number: 4595458-1Report Type:Expedited (15-DaCompany Report #US_0411108150 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Akathisia Health (Olanzapine) Other Anger Professional (Olanzapine) PS 20 MG/1 AT Anxiety BEDTIME Arthralgia Abilify Condition Aggravated (Aripiprazole) C Contusion Clozaril (Clozapine) C Delusion Seroquel (Quetiapine Diabetes Mellitus Fumarate) C Dilatation Atrial Risperdal Diplopia (Risperidone) C Drug Abuser Geodon (Ziprasidone Drug Screen Positive Hydrochloride) C Dyslipidaemia Thorazine Ecchymosis (Chlorpromazine Electrocardiogram T Wave Hydrochloride) C Abnormal Haldol (Haloperidol Excoriation Decanoate) C Facial Pain Navane (Tiotixene) C Hallucination Depakote (Valproate Headache Semisodium) C Hostility Depakene (Valproate Hypertension Sodium) C Irritability Wellbutrin Laceration (Bupropion Myocardial Infarction Hydrochloride) C Neck Pain Lopressor Nightmare (Metoprolol Paranoia Tartrate) C Psychotic Disorder Prolixin Qrs Axis Abnormal (Fluphenazine Refusal Of Treatment By Hydrochloride) C Patient Cogentin Sinus Arrhythmia (Benzatropine Sleep Apnoea Syndrome Mesilate) C Snoring Zantac (Ranitidine Swelling Hydrochloride) C Treatment Noncompliance Ativan (Lorazepam) C Tremor Victim Of Crime Date:02/24/05ISR Number: 4595507-0Report Type:Expedited (15-DaCompany Report #USA041082467 Age:61 YR Gender:Male I/FU:F Outcome PT Death Blood Cholesterol Increased Fatigue High Density Lipoprotein Decreased Low Density Lipoprotein Increased Myocardial Infarction 24-Jun-2005 12:19 PM Page: 3454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 10 MG DAY Representative Remeron (Mirtazapine Orifarm) C Ambien (Zolpidem Tartrate) C Klonopin (Clonazepam) C Vioxx (Rofecoxib) C Plendil (Felodipine) C Date:02/24/05ISR Number: 4595508-2Report Type:Expedited (15-DaCompany Report #USA050290147 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diverticulitis Consumer Zyprexa-Oral Other Fall (Olanzapine) Hip Fracture (Olanzapine) PS 2.5 MG/2 DAY Infection Intestinal Perforation Intestinal Prolapse Liver Disorder Renal Disorder Spinal Fracture Date:02/24/05ISR Number: 4595564-1Report Type:Expedited (15-DaCompany Report #US_0405102953 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Anxiety Health (Olanzapine) Blood Cholesterol Professional (Olanzapine) PS 30 MG/1 DAY Increased Haloperidol C Blood Triglycerides Paxil (Paroxetine Increased Hydrochloride) C Chest Pain Accupril (Quinapril Decreased Appetite Hydrochloride) C Diabetes Mellitus Seroquel (Quetiapine Insulin-Dependent Fumarate) C Diabetes Mellitus Abilify Non-Insulin-Dependent (Aripiprazole) C Gastroenteritis Multivitamin C Hypertension Folate Sodium C Nausea Otitis Externa Otitis Media Prescribed Overdose Refusal Of Treatment By Patient Splenic Haemorrhage Splenic Rupture Vomiting Weight Increased 24-Jun-2005 12:19 PM Page: 3455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4595566-5Report Type:Expedited (15-DaCompany Report #US_0405103189 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Consumer Humulin-Human Nph Initial or Prolonged Blood Urea Decreased Health Insulin (Rdna) Other Body Mass Index Increased Professional (Human Insulin (Rd PS 40 U Bursitis Zyprexa-Oral Chest Injury (Olanzapine) Chest Wall Pain (Olanzapine) SS Diabetes Mellitus Insulin Humulin Inadequate Control 70/30 C Dysmenorrhoea Ibuprofen C Essential Hypertension Diphenhydramine C Excoriation Acetaminophen General Physical Health W/Propoxyphene C Deterioration Cyclobenzaprine C Haematuria Zestril (Lisinopril) C Hypertension Zithromac Hypokalaemia (Azithromycin) C Myositis Advair Diskus C Pco2 Decreased Prevacid Road Traffic Accident (Lansoprazole) C Schizophrenia Amoxicillin C Somnolence Cephalexin C Sternal Fracture Butalbital, Torticollis Acetaminophen & Trigonitis Caffeine C Urethral Stricture Cipro (Ciprofloxacin Urinary Tract Infection Hydrochloride) C Urine Leukocyte Esterase Betamethasone Positive Dipropionate Vaginal Mycosis W/Clotrimazole C Celebrex (Celecoxib) C Orphenadrine Citrate C Novolin R (Insulin Human) C Phentermine C Sulfamethoxypyrazine /Trimethoprim C Potassium Chloride C Hydrochlorothiazide C Bextra (Valdecoxib) C Neurontin (Gabapentin) C Diflucan (Fluconazole) C Oxybutynin C Phenazopyridine C Insulin Novolin 70/30 C Avandia (Rosiglitazone Maleate) C Lotrel C Wellbutrin (Bupropion Hydrochloride) C Stelazine (Trifluoperazine Hydrochloride) C Glucovance C 24-Jun-2005 12:19 PM Page: 3456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oral Contraceptive Nos C Date:02/24/05ISR Number: 4595568-9Report Type:Expedited (15-DaCompany Report #USA050290379 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Consumer Forteo Initial or Prolonged Pharmaceutical Product (Teriparatide) PS Other Complaint Zyprexa-Oral Pneumonia (Olanzapine) (Olanzapine) SS Diazepam C Tylenol C Aspirin(Acetylsalicy lic Acid) C Lexapro (Escitalopram Oxalate) C Zocor(Simvastatin Ratiopharm) C Wellbutrin(Bupropion Hydrochloride) C Vitamins C Trazadone(Trazodone) C Date:02/24/05ISR Number: 4595598-7Report Type:Expedited (15-DaCompany Report #US_0411108051 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) Other Bronchitis Professional (Olanzapine) PS 10 MG/2 AT Closed Head Injury BEDTIME Fall Darvon Compund-65 C Mental Disorder Zantac (Ranitidine Neck Pain Hydrochloride) C Overdose Demerol (Pethidine Pain In Extremity Hydrochloride) C Urinary Tract Infection Xanax (Alprazolam Dum) C Fioricet C Elavil (Amitriptyline Hydrochloride0 C Lipitor (Atorvastatin Hydrochloride) C Nubain (Nalbuphine) C Vistaril (Hydroxyzine Embonate) C Toradol (Ketorolac Tromethamine) C Prilosec (Omeprazole Ratiopharm) C Droperidol C Phenergan (Promethazine 24-Jun-2005 12:19 PM Page: 3457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Inderal (Propranolol Hydrochloride) C Sinequan (Doxepin Hydrochloride) C Cholestyramine Resin C Benadryl C Valium (Diazepam) C Elavil (Amitriptyline Hydrochloride) C Zyrtec (Cetirizine Hydrochloride) C Stadol (Butorphanol Tartrate) C Nortriptyline C Trazodone C Sumatriptan C Nasarel (Flunisolide) C Flovent (Fluticasone Propionate) C Gentamicin C Risperidone C Ultram (Tramadol Hydrochloride) C Premarin C Albuterol C Flextra-Ds C Guaifenex C Pravastatin C Cyclobenzaprine C Sulfamethoxazole C Orlistat C Rizatriptan C Histex C Zithromax (Azithromycin) C Acetaminophen W/ Hydrocodone C Propoxyphene C Prevacid (Lansoprazole) C Zoloft (Sertraline Hydrochloride) C Dolgic Lq C Imodium (Loperamide Hydrochloride) C Cataflam (Diclofenac Potassium) C Pravachol (Pravastatin Sodium) C Claritin-D 24hour C Date:02/24/05ISR Number: 4595600-2Report Type:Expedited (15-DaCompany Report #US_0405103315 Age:39 YR Gender:Male I/FU:F Outcome PT Hospitalization - Arthralgia Initial or Prolonged Chest Pain Other Difficulty In Walking 24-Jun-2005 12:19 PM Page: 3458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Hypoaesthesia Local Swelling Report Source Product Role Manufacturer Route Dose Duration Mass Consumer Zyprexa-Oral Mitral Valve Incompetence Health (Olanzapine) Neck Pain Professional (Olanzapine) PS 12.5 MG/1 AT Oedema Peripheral BEDTIME Pain In Jaw Zoloft (Sertraline Tricuspid Valve Hydrochloride) C Incompetence Glucophage Xr (Metformin Hydrochloride) C Zocor (Simvastatin Ratiopharm) C Lipitor (Atorvastatin Calcium) C Verapamil C Aspirin (Acetylsalicylic Acid) C Multivitamin C Haldol (Haloperidol Decanoate) C Paxil (Paroxetine Hydrochloride) C Advicor C Colace (Docusate Sodium) C Cozaar (Losartan Potassium) C Allerga (Fexofenadine Hydrochloride) C Lorcet Plus C Tylenol With Codeine C Darvocet-N 100 C Ultram (Tramadol Hydrochloride) C Risperdal (Risperidone) C Percocet C Vicodin C Nasocort (Budesonide) C Cogentin (Benzatropine Mesilate) C Aativan (Lorazepam) C Tranxene (Clorrazepate Dipotassium) C Surbex-T C Mylanta C Milk Of Magnesia C Aripiprazole C Clorazepate Dipotassium C Thiamine Hydrochloride C Benadryl C 24-Jun-2005 12:19 PM Page: 3459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flonase (Fluticasone Propionate) C Date:02/24/05ISR Number: 4595602-6Report Type:Expedited (15-DaCompany Report #US_0502112519 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa-Dispersible Initial or Prolonged Professional (Olanzapine) Company (Olanzapine) PS 40 MG Representative Tegretol (Carbamazepine Rivopharm) C Date:02/24/05ISR Number: 4595630-0Report Type:Expedited (15-DaCompany Report #2005-125347-NL Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Mirtazapine PS 15 MG/30 MG Initial or Prolonged Blood Amylase Increased Health Olanzapine SS 2.5 MG 2 WK Lipase Increased Professional Venlafaxine Other Hydrochloride SS 75 MG/150 MG 3 WK Lithium Carbonate SS DF/2 DF/1 DF/1.5 DF 13 DAY Reboxetine SS 4 MG 3 DAY Zoplicone C Lorazepam C Date:02/24/05ISR Number: 4595774-3Report Type:Expedited (15-DaCompany Report #A044-002-005478 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Aricept (Donepezil Initial or Prolonged Haemodialysis Health Hydrochloride) PS ORAL 10 MG, 1 IN 1 Neuroleptic Malignant Professional D, ORAL Syndrome Seroquel (Quetiapine Renal Failure Acute Fumarate) SS 400 MG Rhabdomyolysis Tavor (Lorazepam) SS 6 MG Thombran (Trazodone Hydrochloride) SS 400 MG Quilonum (Lithium Acetate) SS 675 MG Zyprexa (Olanzapine) SS 20 MG Zeldox (Ziprasidone Hydrochloride) SS 80 MG Haldol (Haloperidol) SS 6 MG Date:02/24/05ISR Number: 4595792-5Report Type:Expedited (15-DaCompany Report #EWC040539350 Age:35 YR Gender:Male I/FU:F Outcome PT Death Arrhythmia Cardiac Arrest Cardiac Disorder Drug Level Increased Dyspnoea Hallucination 24-Jun-2005 12:19 PM Page: 3460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Self-Injury Liver Disorder Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 10 MG Professional Tavor (Lorazepam) C Company Talofen (Promazine Representative Hydrochloride) C Other Seroquel (Quetiapine Fumarate) C Tolep (Oxcarbazepine) C Stilnox (Zolpidem Tartrate) C Tavor (Lorazepam) C Date:02/24/05ISR Number: 4595894-3Report Type:Expedited (15-DaCompany Report #US_0502112386 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Company Representative Date:02/24/05ISR Number: 4595896-7Report Type:Expedited (15-DaCompany Report #GBS050216578 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Empyema Foreign Zyprexa-Oral Hospitalization - Leukaemia Health (Olanzapine) Initial or Prolonged Malignant Neoplasm Professional (Olanzapine) PS Other Progression Other Venlafaxine C Pneumonia Date:02/24/05ISR Number: 4595897-9Report Type:Expedited (15-DaCompany Report #JP_050205868 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Paxil (Paroxetine Representative Hydrochloride) C Other Amlodipine (Amlodipine Besilate) C Pantosin (Pantethine) C Maglax (Magnesium Oxide) C Depas (Etizolam) C 24-Jun-2005 12:19 PM Page: 3461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4595900-6Report Type:Expedited (15-DaCompany Report #FR_041205498 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Zyprexa-Oral Blood Testosterone Health (Olanzapine) Increased Professional (Olanzapine) PS 10 MG DAY Company Representative Date:02/24/05ISR Number: 4595901-8Report Type:Expedited (15-DaCompany Report #GBS041216161 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Foreign Olazapine-Oral Constipation Consumer (Olanzapine) PS 10 MG/2 DAY Extrapyramidal Disorder Health Clopidogrel C Neuromyopathy Professional Other Date:02/24/05ISR Number: 4595903-1Report Type:Expedited (15-DaCompany Report #JP_050105585 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Foreign Zyprexa-Oral Initial or Prolonged Thrombocytopenia Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG DAY Company Depromel Representative (Fluvoxamine) C Other Reslin (Trazodone Hydrochloride) C Amoban (Zopiclone) C Magnesium Oxide C Pursennid C Amicaliq C Date:02/24/05ISR Number: 4595904-3Report Type:Expedited (15-DaCompany Report #EWC040940749 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG DAY 1 YR Company Impromen Decanoas Representative (Bromperidol Other Decanoate) C Temesta (Lorazepam) C Akineton (Biperiden Lactate) C Date:02/24/05ISR Number: 4595906-7Report Type:Expedited (15-DaCompany Report #EWC050242476 Age: Gender:Female I/FU:F Outcome PT Report Source Metrorrhagia Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 3462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Olanzapine-Oral (Olanzapine) PS 10 MG Microgynon C Date:02/24/05ISR Number: 4595926-2Report Type:Expedited (15-DaCompany Report #JP_041105135 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Foreign Zyprexa-Oral Initial or Prolonged Study (Olanzapine) PS 5 MG DAY Health Ganaton (Itopride Professional Hydrochloride) C Other Alfacalcidol C Magnesium Oxide C Cercine (Diazepam) C Lendormin (Brotizolam) C Pursennid C Date:02/24/05ISR Number: 4595930-4Report Type:Expedited (15-DaCompany Report #DE_050215210 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) PS 15 MG DAY Aspartate Professional Jodthyrox C Aminotransferase Other Increased Gamma-Glutamyltransferase Increased Liver Disorder Date:02/24/05ISR Number: 4595931-6Report Type:Expedited (15-DaCompany Report #DE_050215232 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prothrombin Time Foreign Zyprexa-Oral Prolonged Health (Olanzapine) PS 5 MG DAY Professional Fluoxetine Other (Fluoxetine) C Voltaren (Diclofenac Potassium) C Date:02/24/05ISR Number: 4595938-9Report Type:Expedited (15-DaCompany Report #DE_050215209 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Zyprexa-Oral Initial or Prolonged Drug Ineffective Health (Olanzapine) Faecaloma Professional (Olanzapine) PS 20 MG DAY Subileus Other Fluanxol Vomiting (Flupentixol White Blood Cell Count Decanoate) C Increased Eunerpan (Melperone 24-Jun-2005 12:19 PM Page: 3463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Leponex (Clozapine) C Biperiden C Date:02/24/05ISR Number: 4595939-0Report Type:Expedited (15-DaCompany Report #EWC050242644 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Electrocardiogram Health (Olanzapine) Abnormal Professional (Olanzapine) PS 5 MG/1 DAY Hypokalaemia Other Benzodiazepine C Date:02/24/05ISR Number: 4595941-9Report Type:Expedited (15-DaCompany Report #EWC050242613 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Olanzapine-Ora; Initial or Prolonged Cardiomyopathy Health (Olanzapine) PS 5 MG/2 DAY Professional Omeprazole C Company Cyclocur C Representative Brufen (Ibuprofen) C Other Atarax (Hydroxyzine) C Date:02/24/05ISR Number: 4595942-0Report Type:Expedited (15-DaCompany Report #EWC050242659 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Foreign Zyprexa-Oral Diabetic Nephropathy Health (Olanzapine) Diabetic Retinopathy Professional (Olanzapine) PS 10 MG/2 DAY Neuropathy Peripheral Other Largactil (Chlorpromazine Hydrochloride) C Citalopram C Date:02/24/05ISR Number: 4595944-4Report Type:Expedited (15-DaCompany Report #EWC050242684 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa-Dispersible Conduction Disorder Health (Olanzapine) Sudden Death Professional (Olanzapine) PS 10 MG/2 DAY Company Depakin Chrono Representative (Valproate Sodium) C Other Tavor (Lorazepam) C Kcl-Retard (Potassium Chloride) C Pursennid C Date:02/24/05ISR Number: 4595949-3Report Type:Expedited (15-DaCompany Report #EWC050242713 Age:33 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Confusional State Delirium 24-Jun-2005 12:19 PM Page: 3464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Dysarthria Family Stress Report Source Product Role Manufacturer Route Dose Duration Impulsive Behaviour Foreign Zyprexa-Dispersible Intentional Misuse Health (Olanzapine) PS 250MG/1 Loss Of Employment Professional Idalprem (Lorazepam) C Nervousness Other Overdose Psychomotor Agitation Suicide Attempt Thinking Abnormal Date:02/24/05ISR Number: 4595951-1Report Type:Expedited (15-DaCompany Report #DE_050215211 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Zyprexa-Oral Initial or Prolonged Body Temperature Health (Olanzapine) PS 30MG/1 DAY Other Fluctuation Professional Euthyrox C-Reactive Protein Other (Levothyroxine Increased Sodium) C Cardiac Failure Risperdal Myocarditis (Risperidone) C Prescribed Overdose Arkineton Retard (Bepiriden Hydrochloride) C Leponex (Clozapine) C Tavor (Lorazepam) C Date:02/24/05ISR Number: 4595978-XReport Type:Expedited (15-DaCompany Report #EWC050242710 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Zyprexa-Rapid-Acting Hospitalization - Health Im (Olanzapine) PS 10 MG/2 DAY Initial or Prolonged Professional Risperdal (Risperidone) C Serenace (Haloperidol) C Benzodiazepine C Date:02/24/05ISR Number: 4596025-6Report Type:Expedited (15-DaCompany Report #FR_050205805 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 10 MG DAY Aminotransferase Other Xanax (Alprazolam Increased Dum) C Hepatocellular Damage Lutenyl (Nomegestrol Acetate) C 24-Jun-2005 12:19 PM Page: 3465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/05ISR Number: 4592045-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0547269A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Paxil PS Glaxosmithkline ORAL 40MG Per day Anxiety Zyprexa SS Completed Suicide Conversion Disorder Decreased Interest Delusion Paranoia Sleep Disorder Date:02/25/05ISR Number: 4595202-8Report Type:Expedited (15-DaCompany Report #US_0502111640 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine/ Professional Fluoxetine (Unknown Company Dose)(Ola PS Representative Date:02/28/05ISR Number: 4592299-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12773792 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Palpitations Pharmaceutical Company, Ltd. ORAL 5 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Zyprexa SS Lithium C Date:02/28/05ISR Number: 4592340-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12793386 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose ranged from 15 to 30 mg/day. 17 DAY Clozapine SS ORAL Dose ranged from 25 mg/twice daily up to 400 mg/day, Clozapine SS ORAL Dose ranged from 25 mg/twice daily up to 400 mg/day, Zyprexa SS ORAL Dose ranged from 10 to 20 mg/day 28 DAY Losartan C Docusate Sodium C 24-Jun-2005 12:19 PM Page: 3466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ferrous Sulfate C Trazodone Hcl C Apothecon Chlorpromazine C Venlafaxine Hcl C Mirtazapine C Date:02/28/05ISR Number: 4593025-7Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0291749-00 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Akineton Tabletten PS ORAL Initial or Prolonged Drug Interaction Olanzapine SS ORAL Tremor Olanzapine SS Potassium Iodide SS ORAL Diazepam C ORAL 25 DAY Diazepam C ORAL 25 DAY Diazepam C ORAL 25 DAY Amisulpride I ORAL 5 DAY Haloperidol I ORAL 12 DAY Date:02/28/05ISR Number: 4596937-3Report Type:Expedited (15-DaCompany Report #2005019377 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Neurontin Initial or Prolonged Electrophoresis Protein Professional (Gabapentin) PS ORAL 300 MG (1 IN1 Other Abnormal Company D), ORAL Faecal Occult Blood Representative Vicodin (Hydrocodone Positive Bitartrate, Fatigue Paracetamol) SS ORAL 10/650 MG ( 1 Hypercalcaemia IN 1 D), ORAL Hypothyroidism Olanzapine/Fluoxetin Irritable Bowel Syndrome e Hydrochloride Palpitations (Fluoxetine Pyrexia Hydrochloride, , Renal Failure Acute Olanzapine) SS ORAL 6/25 (1 IN 1 Sinusitis D), ORAL Date:02/28/05ISR Number: 4597566-8Report Type:Direct Company Report #CTU 241623 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Zyprexa 30mg PS Hospitalization - Fatigue Initial or Prolonged Psychomotor Hyperactivity Restlessness Date:03/01/05ISR Number: 4597188-9Report Type:Expedited (15-DaCompany Report #DEWYE443221FEB05 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Study Trevilor Initial or Prolonged Blood Amylase Increased (Venlafaxine Lipase Increased Hydrochloride, Tablet, 0) PS SEE IMAGE 21 DAY Edronax (Reboxetine, , 0) SS 4 MG PER DAY; 3 DAY 24-Jun-2005 12:19 PM Page: 3467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quilonum - Slow Release (Lithium Carbonate, , 0) SS SEE IMAGE 6 DAY Zyprexa (Olanzapine, , 0) SS 2.5 MG PER DAY; 14 DAY Remergil (Mirtazapine, , 0) SS 30 MG PER DAY; 7 DAY . C SEC . C . C . C . C Date:03/01/05ISR Number: 4597877-6Report Type:Expedited (15-DaCompany Report #USA050290334 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematemesis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 20 MG Representative Zyprexa-Dispersible (Olanzapine) (Olanzapine) SS 20 MG Date:03/01/05ISR Number: 4597879-XReport Type:Expedited (15-DaCompany Report #US_0501110994 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Zyprexa-Oral Arthralgia (Olanzapine) Blood Cholesterol (Olanzapine) PS Increased Depakote(Valproate Coronary Artery Semisodium) C Restenosis Wellbutrin(Bupropion Coronary Artery Stenosis Hydrochloride) C Cough Neomycin, Polymyxin Diabetes Mellitus B Sulfate, Non-Insulin-Dependent Hydrocortisone C Dyspnoea Augmentin C Electrocardiogram St Nasonex (Mometasone Segment Depression Furoate) C Hypoglycaemia Claritin-D C Ischaemia Nitroquick (Glyceryl Joint Swelling Trinitrate) C Low Density Lipoprotein Increased Palpitations Respiratory Tract Congestion Road Traffic Accident Sudden Onset Of Sleep 24-Jun-2005 12:19 PM Page: 3468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/05ISR Number: 4598168-XReport Type:Direct Company Report #CTU 241659 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Olanzapine 5 Mg Tab PS 10 MG Q AM Initial or Prolonged Laboratory Test Abnormal AND 15 MG Q Medication Error PM Neuroleptic Malignant Sertraline C Syndrome Clonazepam C Trazodone C Oxycodone/Apap C Methadone C Hydrochlorothiazide C Docusate C Senna C Date:03/02/05ISR Number: 4595947-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050204773 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebellar Syndrome Topamax PS Coordination Abnormal Topamax SS Dizziness Ergenyl SS UNKNOWN Fall Zyprexa SS UNKNOWN Gait Disturbance Jatrosom N SS UNKNOWN Hypnorex SS UNKNOWN Tavor SS UNKNOWN Tavor SS UNKNOWN Mpa SS UNKNOWN Magnesium SS UNKNOWN Estraderm SS UNKNOWN Date:03/03/05ISR Number: 4597696-0Report Type:Expedited (15-DaCompany Report #IT-ABBOTT-05P-083-0292115-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Depakine Chrono PS ORAL Sudden Death Depakine Chrono SS Olanzapine SS ORAL Olanzapine SS Lorazepam SS INTRAVENOUS BOLUS Lorazepam SS Potassium Chloride C ORAL Senna Leaf C ORAL Date:03/03/05ISR Number: 4599157-1Report Type:Expedited (15-DaCompany Report #USA050290579 Age:40 YR Gender:Female I/FU:I Outcome PT Other Drug Dependence Fatigue Insomnia Loss Of Consciousness Nausea Paralysis Therapeutic Response Decreased Treatment Noncompliance 24-Jun-2005 12:19 PM Page: 3469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG/1 DAY Xanax (Alprazolam Dum) C Date:03/03/05ISR Number: 4599159-5Report Type:Expedited (15-DaCompany Report #USA050290707 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Consumer Zyprexa-Dispersible Initial or Prolonged (Olanzapine) (Olanzapine) PS 30 MG DAY Depakene (Valproate Sodium) C Date:03/03/05ISR Number: 4599464-2Report Type:Expedited (15-DaCompany Report #US_0502112386 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Company Representative Date:03/03/05ISR Number: 4599494-0Report Type:Expedited (15-DaCompany Report #USA050289721 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Strattera Anxiety (Atomoxetine Disease Recurrence Hydrochloride) PS 25 MG DAY Drug Effect Decreased Zyprexa-Oral Insomnia (Olanzapine)(Olanzap Pharmaceutical Product ine) SS 10 MG DAY Complaint Strattera Somnolence (Atomoxetine Thinking Abnormal Hydrochloride) C Weight Increased Lexapro (Escitalopram Oxalate) C Effexor (Venlfaxine Hydrochloride) C Cytomel (Liothyronine Sodium) C Caffeine C 24-Jun-2005 12:19 PM Page: 3470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4599573-8Report Type:Expedited (15-DaCompany Report #US_0410107180 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Consumer Zyprexa-Oral Increased Health (Olanzapine) Arthralgia Professional (Olanzapine) PS 15 MG/2 DAY Aspartate Paxil (Paroxetine Aminotransferase Hydrochloride) C Increased Celebrex (Celecoxib) C Back Pain Premarin C Basal Cell Carcinoma Zantac (Ranitidine Breast Microcalcification Hydrochloride) C Bronchitis Bextra (Valdecoxib) C Condition Aggravated Potassium C Dental Caries Erythromycin Depression (Erythromycin) C Diabetes Mellitus Timolol C Diarrhoea Lotrisone C Drug Effect Decreased Xenical (Orlistat) C Dyslipidaemia Lasix (Furosemide) C Dysphagia Famvir (Penciclovir) C Dyspnoea Exertional Doxycycline C Ear Disorder Ceohalexin C Fatigue Prilosec (Omeprazole Fungal Infection Ratiopharm) C Gastrointestinal Pain Penta-Triamterene Glaucoma Hctz C Glycosuria Ultram (Tramadol Glycosylated Haemoglobin Hydrochloride) C Increased Quinine C Groin Abscess Timoptic (Timolol Herpes Simplex Maleate) C Hordeolum Zyrtec (Cetirizine Hyperglycaemia Hydrochloride) C Hyperphagia Flexeril Hypertension (Cyclobenzaprine Hypoglycaemia Hydrochloride) C Insomnia Zoloft (Sertraline Lymphocytic Dermatitis Hydrochloride) C Musculoskeletal Pain Naproxen (Naproxen Obesity Sodium) C Oedema Hydrocodone C Periodontal Disease Promethazine C Polydipsia Clorotrimeton Polyuria (Chlorphenamine Rash Maleate) C Rash Maculo-Papular Sucralfate C Restlessness Glucovance C Sinusitis Glyburide C Tachycardia Diclofenac Sodium C Weight Decreased Panlor Ss C Wound Gentamicin C Prevacid (Lansoprazole) C Easprin (Acetylsalicylic Acid) C Patanol (Olopatadine Hydrochoride) C Centrum Silver C Cyclobenzaprine C 24-Jun-2005 12:19 PM Page: 3471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4599606-9Report Type:Expedited (15-DaCompany Report #US_001255431 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Consumer Zyprexa-Oral Initial or Prolonged Delusion (Olanzapine) Diarrhoea (Olanzapine) PS 15 MG DAY 25 MON Dizziness Paxil (Paroxetine Feeling Abnormal Hydrochloride) C Gastrooesophageal Reflux Depakote (Valproate Disease Semisodium) C Psychiatric Symptom Smoker Vision Blurred Visual Field Defect Date:03/03/05ISR Number: 4599607-0Report Type:Expedited (15-DaCompany Report #US_0502112134 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cor Pulmonale Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus (Olanzapine) Other Hernia (Olanzapine) PS Hysterectomy Date:03/03/05ISR Number: 4599610-0Report Type:Expedited (15-DaCompany Report #USA050290890 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Zyprexa - Oral Increased Professional (Olanzapine) Hepatic Enzyme Increased Company (Olanzapine) PS Insomnia Representative Date:03/03/05ISR Number: 4599613-6Report Type:Expedited (15-DaCompany Report #USA050290817 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) PS Date:03/03/05ISR Number: 4599635-5Report Type:Expedited (15-DaCompany Report #USA050289604 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombosis Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 30 MG DAY Representative Date:03/03/05ISR Number: 4599638-0Report Type:Expedited (15-DaCompany Report #US_0409105404 Age:26 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 3472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Abdominal Hernia Abdominal Pain Abdominal Pain Upper Abdominal Tenderness Anaesthesia Anion Gap Increased Anxiety Asthenia Back Pain Blood Gases Abnormal Blood Glucose Decreased Blood Osmolarity Increased Blood Ph Decreased Blood Sodium Decreased Carpal Tunnel Syndrome Choking Sensation Chromaturia Confusional State Constipation Cough Decreased Appetite Dehydration Depressed Level Of Consciousness Diabetes Mellitus Diabetic Ketoacidosis Diarrhoea Difficulty In Walking Disturbance In Attention Dizziness Drug Effect Decreased Drug Ineffective Dry Skin Dyslipidaemia Dyspnoea Emotional Distress Eye Pain Fatigue Flatulence Fluid Retention Headache Hepatomegaly Hyperhidrosis Hypoaesthesia Hypoglycaemia Joint Stiffness Loss Of Consciousness Malaria Muscle Strain Muscle Twitching Musculoskeletal Stiffness Nasal Congestion Nausea Neck Pain Nerve Compression Nerve Injury Odynophagia 24-Jun-2005 12:19 PM Page: 3473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oral Soft Tissue Disorder Pain Pco2 Decreased Report Source Product Role Manufacturer Route Dose Duration Pharyngolaryngeal Pain Consumer Zyprexa-Oral Polydipsia Health (Olanzapine) Polyuria Professional (Olanzapine) PS 20 MG/1 AT Poor Peripheral BEDTIME Circulation Isoniazid C Pruritus Paroxetine C Pyrexia Iburpofen Renal Failure Chronic (Ibuprofen) C Reticulocyte Count Amoxicillin C Increased Vitamins B-6 C Road Traffic Accident Nicoderm (Nicotine) C Sinusitis Geodon (Ziprasidone Skin Chapped Hydrochloride) C Sleep Apnoea Syndrome Lotrisone C Sneezing Wellbutrin Snoring (Bupropion Suicidal Ideation Hydrochloride) C Testicular Pain Thinking Abnormal Tinea Pedis Treatment Noncompliance Tremor Tuberculosis Vision Blurred Weight Decreased Weight Increased Date:03/03/05ISR Number: 4599681-1Report Type:Expedited (15-DaCompany Report #USA050290873 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Cymbalta (Duloxetine Initial or Prolonged Disturbance In Attention Hydrochloride) PS 60 MG Other Dizziness Zyprexa -Oral Drug Ineffective (Olanzapine) Intentional Self-Injury (Olanzapine) SS Mania Seroquel (Quetiapine Panic Disorder Fumarate) C Skin Laceration Geodon (Ziprasidone Thermal Burn Hydrochloride) C Vomiting Weight Increased Date:03/03/05ISR Number: 4599698-7Report Type:Expedited (15-DaCompany Report #USA050290739 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Prozac-Oral Initial or Prolonged Professional (Fluoxetine) Company (Fluoxetine Representative Hydrochloride) PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS 5 MG DAY 24-Jun-2005 12:19 PM Page: 3474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4599700-2Report Type:Expedited (15-DaCompany Report #USA050290618 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Prozac-Oral Initial or Prolonged Depressed Level Of (Fluoxetine Other Consciousness Hydrochloride) PS 20 MG Malaise Zyprexa-Oral (Olanzapine) (Olanzapine) SS Relafen (Nabumetone) C Tegretol (Carbamazepine Rivopharm) C Risperdal (Risperidone) C Baby Aspirin (Acetylsalicylic Acid) C Date:03/03/05ISR Number: 4599731-2Report Type:Expedited (15-DaCompany Report #USA050291129 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Symbyax-Olanzapine 6 Initial or Prolonged Depression Professional Mg / Fluoxetine 25mg Other Mania Company (Olanzapin PS Pneumonia Representative Zyprexa-Oral Pulmonary Embolism (Olanzapine) Weight Increased (Olanzapine) SS 5 MG/1 DAY Topamax (Topiramate) C Vytorin C Date:03/03/05ISR Number: 4599741-5Report Type:Expedited (15-DaCompany Report #US_0502112883 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Date:03/03/05ISR Number: 4599786-5Report Type:Expedited (15-DaCompany Report #USA050290522 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Gallbladder Operation (Olanzapine) Pollakiuria (Olanzapine) PS 10 MG AT Renal Pain BEDTIME Visual Acuity Reduced Amaryl (Glimepiride) C Xanax (Alprazolam Dum) C Monopril (Fosinopril Sodium) C Coumadin (Warfarin Sodium) C 24-Jun-2005 12:19 PM Page: 3475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4599788-9Report Type:Expedited (15-DaCompany Report #USA050290523 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Zyprexa-Oral Agitation Professional (Olanzapine) Circulatory Collapse Company (Olanzapine) PS 10 MG Myocardial Infarction Representative Zyprexa-Rapid-Acting Im (Olanzapine) SS Date:03/03/05ISR Number: 4599865-2Report Type:Expedited (15-DaCompany Report #JP_041105135 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Foreign Zyprexa-Oral Initial or Prolonged Oral Intake Reduced Study (Olanzapine) Parkinson'S Disease Health (Olanzapine) PS 5 MG DAY Pneumonia Professional Ganaton (Itopride Other Hydrochloride) C Alfacalcidol C Magnesium Oxide C Circine (Diazepam) C Lendormin (Brotizolam) C Pursennid C Date:03/03/05ISR Number: 4599869-XReport Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abulia Foreign Zyprexa Oral Hospitalization - Blood Creatine Literature (Olanzapine) Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 10 MG DAY Other Blood Pressure Decreased Professional Serenace Culture Stool Positive Company (Haloperidol) C Decreased Appetite Representative Dehydration Other Depressed Level Of Consciousness Diabetic Coma Diabetic Ketoacidosis Diet Refusal Haemodialysis Heart Rate Increased Hyperventilation Hypotension Nausea Obesity Pneumonia Pneumonia Staphylococcal Psychotic Disorder Pyrexia Renal Failure Acute Restlessness Speech Disorder Staphylococcal Infection Tachypnoea Urinary Tract Infection Staphylococcal Vomiting 24-Jun-2005 12:19 PM Page: 3476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4600037-3Report Type:Expedited (15-DaCompany Report #DE_050215257 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 3 WK Company Representative Other Date:03/03/05ISR Number: 4600044-0Report Type:Expedited (15-DaCompany Report #AU_050208376 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Zyprexa-Oral Paranoia Health (Olanzapine) Psychotic Disorder Professional (Olanzapine) PS Other Date:03/03/05ISR Number: 4600048-8Report Type:Expedited (15-DaCompany Report #GBS050216652 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:03/03/05ISR Number: 4600062-2Report Type:Expedited (15-DaCompany Report #US_0502112390 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS Professional Midazolam C Company Diazepam C Representative Other Date:03/03/05ISR Number: 4600083-XReport Type:Expedited (15-DaCompany Report #EWC050242710 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Zyprexa Hospitalization - Myocardial Infarction Health -Rapid-Acting Im Initial or Prolonged Professional (Olanzapine) PS 10 MG/2 DAY Risperdal (Risperidone) C Serenace (Haloperidol) C Benzodiazepines C 24-Jun-2005 12:19 PM Page: 3477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4600100-7Report Type:Expedited (15-DaCompany Report #GBS050216631 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Foreign Prozac-Oral Initial or Prolonged Amenorrhoea Literature (Fluoxetine) Other Automatism, Command Health (Fluoxetine Blood Prolactin Increased Professional Hydrochloride) PS 20 MG DAY Delusion Of Reference Other Olanzapine-Oral Dependent Personality (Olanzapine) SS 30 MG DAY Disorder Zuclopenthixol C Depression Lithium C Drug Ineffective Chlorpromazine C Galactorrhoea Procyclidine C Hallucination, Auditory Thyroxine Hallucinations, Mixed (Levothyroxine Headache Sodium) C Hyperhidrosis Oral Contraceptive Hypotension Nos C Logorrhoea Mania Mood Swings Persecutory Delusion Pituitary Tumour Benign Pyramidal Tract Syndrome Salivary Hypersecretion Schizoaffective Disorder Somatic Hallucination Stress Thought Insertion Urinary Incontinence Vision Blurred Visual Field Tests Abnormal Date:03/03/05ISR Number: 4600103-2Report Type:Expedited (15-DaCompany Report #JP_041105017 Age:38 YR Gender:Female I/FU:I Outcome PT Death Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Creatine Phosphokinase Increased Cardiac Arrest Decreased Appetite Electrocardiogram Abnormal Gait Disturbance Hepatic Function Abnormal Hyperglycaemia Increased Appetite Insomnia Respiratory Arrest Restlessness Resuscitation Throat Irritation 24-Jun-2005 12:19 PM Page: 3478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Weight Increased White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Date:03/03/05ISR Number: 4600106-8Report Type:Expedited (15-DaCompany Report #JP_050205863 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Levotomin Representative (Levomepromazine Other Maleate) C Date:03/03/05ISR Number: 4600283-9Report Type:Expedited (15-DaCompany Report #FR_041205458 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sedation Foreign Zyprexa-Rapid Health Professional Olanzapine PS INTRAMUSCULAR 10 MG DAY Company Tercian Representative (Cyamemazine) C Other Loxapac (Loxapine Succinate) C Tranxene (Clorazepate Dipotassium) C Date:03/03/05ISR Number: 4600286-4Report Type:Expedited (15-DaCompany Report #US_0501111571 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Zyprexa Initial or Prolonged Somnolence Health Suicide Attempt Professional (Olanzapine) PS ORAL Other Date:03/03/05ISR Number: 4600289-XReport Type:Expedited (15-DaCompany Report #JP_050205772 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa Life-Threatening Coma Health Other Drug Interaction Professional Dysphagia Company (Olanzapine) PS ORAL 10 MG DAY Hypoxic Encephalopathy Representative Contomin Injury Asphyxiation Other (Chlorpromazine Vomiting Hydrochloride) C Rohypnol (Flunitrazepam Eg) C Pursennid C 24-Jun-2005 12:19 PM Page: 3479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Horizon (Diazepam) C Ubretid (Distigmine Bromide) C Date:03/03/05ISR Number: 4600295-5Report Type:Expedited (15-DaCompany Report #JP_050205868 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Foreign Zyprexa Initial or Prolonged Health Professional (Olanzapine) PS ORAL 10 MG DAY Company Paxil Representative (Paroxetine Other Hydrochloride) C Amlodin (Amlodipine Besilate) C Pantosin (Pantethine) C Maglax (Magnesium Oxide) C Depas (Etizolam) C Date:03/03/05ISR Number: 4600298-0Report Type:Expedited (15-DaCompany Report #JP_040904404 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Foreign Zyprexa Initial or Prolonged Mania Health (Olanzapine) PS ORAL 5 MG DAY Purpura Professional Depakene-R Company (Valproate Representative Sodium) C Other Rohypnol (Flunitrazepam Eg) C Amoban (Zopiclone) C Lithium C Date:03/03/05ISR Number: 4600303-1Report Type:Expedited (15-DaCompany Report #FR_041205361 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Zyprexa Initial or Prolonged Haemorrhagic Cerebral Health Infarction Professional (Olanzapine) PS ORAL 15 MG/1 DAY Systolic Hypertension Other Date:03/03/05ISR Number: 4600306-7Report Type:Expedited (15-DaCompany Report #FR_050105608 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Zyprexa Initial or Prolonged Trismus Health (Olanzapine) PS ORAL 30 MG/1 DAY Professional Haldol Other (Haloperidol Decanoate) C Sulfarlem (Anethole Trithione) C 24-Jun-2005 12:19 PM Page: 3480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4600307-9Report Type:Expedited (15-DaCompany Report #EWC050242684 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zyprexa Conduction Disorder Health (Olanzapine) PS 10 MG/2 DAY Sudden Death Professional Depakin Chrono Company Representative (Valproate Sodium) C Other Tavor (Lorazepam) C Kcl-Retard (Potassium Chloride) C Pursennid C Date:03/04/05ISR Number: 4598079-XReport Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0291615-00 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Depakote PS ORAL 7 DAY Initial or Prolonged Drug Level Above Depakote SS ORAL 7 DAY Therapeutic Diazepam SS ORAL 1 percent Encephalopathy solution, 90 Fall gtts 11 DAY Hypotonia Diazepam SS ORAL 90 gtts 11 DAY Sedation Diazepam SS ORAL 70 gtt 11 DAY Diazepam SS ORAL 60 gtts 11 DAY Zopiclone SS ORAL 18 DAY Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Cyamemazine C ORAL 2 DAY Paroxetine Hydrochloride C ORAL 2 DAY Date:03/04/05ISR Number: 4598083-1Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0291616-00 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Depakote PS ORAL 500 mg Initial or Prolonged Anxiety tablets 14 DAY Delusion Levomepromazine SS ORAL Solution 4 Disorientation percent 7 DAY Drug Ineffective Olanzapine SS ORAL 14 DAY Hallucination, Visual Clonazepam C ORAL Cyamemazine C ORAL 5 DAY Zopiclone C ORAL Alimemazine Tartrate C UNKNOWN Haldol C UNKNOWN Hydroxyzine Hydrochloride C ORAL Date:03/04/05ISR Number: 4598733-XReport Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0359987A Age:54 YR Gender:Male I/FU:F Outcome PT Death Cardiovascular Disorder Cerebrovascular Accident 24-Jun-2005 12:19 PM Page: 3481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Circulatory Collapse Deep Vein Thrombosis Influenza Like Illness Report Source Product Role Manufacturer Route Dose Duration Myocardial Infarction Paroxetine PS Glaxosmithkline ORAL 40MG Per day Pulmonary Embolism Olanzapine SS ORAL 2.5MG Per day Pulmonary Hypertension Date:03/04/05ISR Number: 4600342-0Report Type:Expedited (15-DaCompany Report #2002133055US Age:3 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Diphenhydramine Multiple Drug Overdose Health (Diphenhydramine) PS ORAL ORAL Professional Fluoxetine (Fluoxetine) SS Olanzapine (Olanzapine) SS Date:03/07/05ISR Number: 4601002-2Report Type:Direct Company Report #CTU 242178 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyprexa PS Eli Lilly And Company Zyrtec SS Pfizer Date:03/07/05ISR Number: 4601004-6Report Type:Direct Company Report #CTU 242145 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Zyrtec PS Pfizer Zyprexa SS Date:03/07/05ISR Number: 4601047-2Report Type:Direct Company Report #CTU 242205 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Zyprexa Eli Lilly PS Eli Lilly ORAL 10MG PO QHS; 2.5MG PO QAM Benadryl C Date:03/07/05ISR Number: 4602501-XReport Type:Expedited (15-DaCompany Report #2004071266 Age:34 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS Intentional Misuse Professional Olanzapine (Olanzapine) SS Clonazepam (Clonazepam) SS 24-Jun-2005 12:19 PM Page: 3482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/05ISR Number: 4602664-6Report Type:Expedited (15-DaCompany Report #2005GB00397 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Seroquel PS Obstructive Airways Health Olanzapine SS 20 MG DAILY Disorder Professional Respiratory Arrest Other Date:03/07/05ISR Number: 4602717-2Report Type:Expedited (15-DaCompany Report #US_0407104230 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Limb Consumer Zyprexa-Oral Initial or Prolonged Aggression Health (Olanzapine) Other Alanine Aminotransferase Professional (Olanzapine) PS 20 MG DAY Increased Prozac-Oral Anxiety (Fluoxetine) Back Pain (Fluoxetine Bacterial Infection Hydrochloride) SS 40 MG AT Blood Alkaline BEDTIME Phosphatase Increased Paxil (Paroxetine Blood Cholesterol Hydrochloride) C Abnormal Trazadone Blood Sodium Decreased (Trazadone) C Cellulitis Elavil Condition Aggravated (Amitriptyline Decreased Appetite Hydrochloride) C Depression Glyburide C Diabetes Mellitus Metformin C Dizziness Regular Insulin Erythema (Insulin) C Genital Pruritus Female Cogentin Headache (Benzatropine Hypoaesthesia Mesilate) C Menopausal Disorder Simvastatin Oedema Peripheral Ratiopharm Osteomyelitis (Simvastatin Otitis Media Ratiopharm) C Pain Seroquel (Quetiapine Pain In Extremity Fumarate) C Paranoia Pollakiuria Refusal Of Treatment By Patient Suicidal Ideation Tenderness Thirst Tinea Cruris Ulcer Vision Blurred Visual Acuity Reduced Vulval Abscess Weight Increased 24-Jun-2005 12:19 PM Page: 3483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/05ISR Number: 4602718-4Report Type:Expedited (15-DaCompany Report #USA050291002 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Zyprexa-Oral Dementia Professional (Olanzapine) Psychotic Disorder Company (Olanzapine) PS 2.5 MG 4 DAY Representative Steroids C Zithromax (Azithromycin) C Date:03/07/05ISR Number: 4602936-5Report Type:Expedited (15-DaCompany Report #2005035266 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Lithium (Lithium) PS 675 MG Initial or Prolonged Drug Interaction Health Lorazepam Haemodialysis Professional (Lorazepam) SS ORAL 6 MG, ORAL Neuroleptic Malignant Trazodone Syndrome Hydrochloride Renal Failure Acute (Trazodone Rhabdomyolysis Hydrochloride) SS 400 MG Ziprasidone (Caps) (Ziprasidone) SS 80 MG Haloperidol (Haloperidol) SS 6 MG Donepezil Hydrochloride (Donepezil Hydrochloride) SS 10 MG (1 IN 1 D) Quetiapine Fumarate (Quetiapine Fumarate) SS 400 MG Olanzapine (Olanzapine) SS 20 MG Date:03/07/05ISR Number: 4602962-6Report Type:Expedited (15-DaCompany Report #B0370903A Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Lithium Salt Cardiac Disorder Literature (Generic) (Lithium Mitral Valve Prolapse Health Salt) PS Sudden Death Professional Olanzapine Ventricular Hypertrophy (Olanzapine) SS Methotrimeprazine (Methotrimeprazine) SS Tropatepine Hydrochloride (Tropatepine Hydrochloride) SS Clomipramine Hcl (Clomipramine Hcl) SS 24-Jun-2005 12:19 PM Page: 3484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/05ISR Number: 4602995-XReport Type:Expedited (15-DaCompany Report #2005035736 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Zeldox (Capsules) Initial or Prolonged Increased Health (Ziprasidone) PS ORAL 80 MG (1 D), Other Chills Professional ORAL Delirium Aricept (Donepezil) SS ORAL 10 MG (1 D), Diarrhoea ORAL Drug Interaction Quetiapine Fumarate Haemodialysis (Quetiapine Neuroleptic Malignant Fumarate) SS 400 MG (1 D) Syndrome Lorazepam Renal Failure Acute (Lorazepam) SS 6 MG (1 D) Rhabdomyolysis Trazodone Hydrochloride (Trazodone Hydrochloride) SS 400 MG (1 D) Haloperidol (Haloperidol) SS 6 MG (1 D) Lithium Acetate (Lithium Acetate) C Olanzapine (Olanzapine) C Date:03/08/05ISR Number: 4603643-5Report Type:Direct Company Report #CTU 242277 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Testosterone Zyprexia 5 Mg PS 1 AT HS Required Decreased Wellbutrin Xl C Intervention to Lexapro C Prevent Permanent Impairment/Damage Date:03/08/05ISR Number: 4604113-0Report Type:Direct Company Report #CTU 242357 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Testosterone Zyprexia 5mg PS 1 DLY Required Decreased Intervention to Prevent Permanent Impairment/Damage Date:03/09/05ISR Number: 4602642-7Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12856845 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Compartment Syndrome Pharmaceutical Insomnia Company, Ltd. 15 mg Memory Impairment 29-Oct-04 to Negative Thoughts 03-Dec-04; 30 Oedema Peripheral mg 03-Dec-04 Overdose to 09-Dec-04 42 DAY Pain In Extremity Olanzapine SS 'till Restlessness 15-Nov-04 5 Suicide Attempt mg; then 24-Jun-2005 12:19 PM Page: 3485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 15-Nov-04 to 22-Nov-04, Oxazepam SS Date:03/09/05ISR Number: 4606078-4Report Type:Expedited (15-DaCompany Report #US_0503113714 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Consumer Zyprexa-Oral (Olanzapine) PS Date:03/09/05ISR Number: 4606080-2Report Type:Expedited (15-DaCompany Report #US_0411107958 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Consumer Zyprexa-Oral Initial or Prolonged Agitation Health (Olanzapine) Other Asthma Professional (Olanzapine) PS 30 MG/1 DAY Blood Triglycerides Humulin-Human Nph Increased Insulin (Rdna) Cellulitis (Human Insulin (Rd SS Chills Humulin-Human Decreased Appetite Regular Insulin Depression (Rdna)(Human Insulin SS Diabetes Mellitus Abilify Inadequate Control (Aripiprazole) C Diabetes Mellitus Quetiapine C Non-Insulin-Dependent Risperdal Gastrooesophageal Reflux (Risperidone) C Disease Haldol (Haloperidol Hepatic Enzyme Increased Decanoate) C Hepatic Steatosis Depakote (Valproate Irritability Semisodium) C Joint Swelling Lithium C Lethargy Bupropion C Liver Disorder Novolin Nph (Insulin Migraine Human Injection, Myocardial Infarction Isophane) C Nausea Novolin R (Insulin Oedema Peripheral Human) C Social Avoidant Behaviour Glyburide Swelling W/Metformin C Tremor Neurontin Urinary Tract Infection (Gabapentin Pfizer) C Ventricular Hypertrophy Desyrel (Trazodone Vision Blurred Hydrochloride) C Vomiting Temazepam C Weight Decreased Lorazepam C Weight Increased Acetaminophen C Femhrt C Claritin (Loratadine) C Lipitor (Atorvastatin Calcium) C Accupril (Quinapril Hydrochloride) C Glucophage (Metformin) C Nicotrol (Nicotine) C 24-Jun-2005 12:19 PM Page: 3486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Allegra (Fexofenadine Hydrochloride) C Risperdal (Risperidone) C Avapro (Irbesartan) C Avandamet C Date:03/09/05ISR Number: 4606084-XReport Type:Expedited (15-DaCompany Report #USA_0502113453 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:03/09/05ISR Number: 4606095-4Report Type:Expedited (15-DaCompany Report #USA050291434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Company (Olanzapine) Imprisonment Representative (Olanzapine) PS 30 MG DAY Risperdal (Risperidone) C Date:03/09/05ISR Number: 4606096-6Report Type:Expedited (15-DaCompany Report #USA050290980 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Consumer Zyprexa-Oral Hospitalization - Parkinsonism (Olanzapine) Initial or Prolonged (Olanzapine) PS 5 MG/2 DAY 2 YR Artane (Trihexyphenidyl Hydrochloride) C Sinemet C Avapro (Irbesartan) C Coreg (Carvedilol) C Date:03/09/05ISR Number: 4606723-3Report Type:Expedited (15-DaCompany Report #US_0502112020 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Hypertension (Olanzapine) Myocardial Infarction (Olanzapine) PS 20 MG/2 DAY Prescribed Overdose Symbyax-Olanzapine / Fluoxetine (Ola SS Zoloft (Sertraline Hydrochloride) C Aricept (Donepezil Hydrochloride) C Glucotrol (Glipizide) C 24-Jun-2005 12:19 PM Page: 3487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4606727-0Report Type:Expedited (15-DaCompany Report #USA041285616 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antidepressant Drug Level Health Zyprexa Other Above Therapeutic Professional Zydis-Dispersible Cardiac Disorder (Olanzapine) Chest Pain (Olanzapine) PS 15 MG DAY Diabetes Mellitus Neurontin Drug Toxicity (Gabapentin Pfizer) C Weight Increased Coumadin (Warfarin Sodium) C Tramadol C Citalopram C Lexapro (Escitalopram Oxalate) C Cozaar (Losartan Potassium) C Toprol Xl (Metoprolol Succinate) C Date:03/09/05ISR Number: 4606819-6Report Type:Expedited (15-DaCompany Report #US_0409105409 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine) Blood Cholesterol Professional (Olanzapine) PS 10 MG DAY Increased 12mg/50 Mg Blood Triglycerides Olanzapine/Fluoxetin Increased e Capsule C Diabetes Mellitus Celexa (Citalopram Non-Insulin-Dependent Hydrobromide) C Erectile Dysfunction Anafranil Headache (Clomipramine Myocardial Infarction Hydrochloride) C Weight Increased Lotrel C Prednisolone C Prednisone (Prednisone0 C Hydrochlorothiazide C Viagra (Sildenafil Citrate) C Darvocet-N C Aspirin (Acetylsalicylic Acid) C Zyrtec (Cetirizine Hydrochloride) C Nasonex (Mometasone Furoate) C Allegra (Fexofenadine Hydrochloride) C Desloratadine C Rabeprazole C Nitroglycerin 9glyceryl Trinitrate0 C 24-Jun-2005 12:19 PM Page: 3488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propoxyphene Hcl And Acetaminophen C Tricor (Fenofibrate) C Zithromax Z-Pack (Azithromycin) C Augumentin C Amoxicillin C Clobetasol C Meperidine C Date:03/09/05ISR Number: 4606836-6Report Type:Expedited (15-DaCompany Report #US_0411108051 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Zyprexa-Oral Initial or Prolonged Arthritis Health (Olanzapine) Other Back Pain Professional (Olanzapine) PS 10 MG/2 AT Blood Cholesterol BEDTIME Increased Darvon Compound-65 C Bronchitis Zanac (Ranitidine Closed Head Injury Hydrochloride) C Diabetes Mellitus Demerol (Pethidine Non-Insulin-Dependent Hydrochloride) C Dizziness Xanax (Alprazolam Dysarthria Dum0 C Fall Fioricet C Flushing Elavil Hypoaesthesia (Amitriptyline Hypoglycaemia Hydrochloride) C Insomnia Lipitor Liver Disorder (Atorvastatin Migraine Calcium) C Nausea Nubain (Nalbuphine) C Neck Pain Vistaril (Hydroxzine Overdose Embonate) C Pain In Extremity Toradol (Ketorolac Pancreatitis Tromethamine) C Paraesthesia Prilosec (Omeprazole Renal Impairment Ratiopharm) C Road Traffic Accident Droperidol C Skin Laceration Phenergan Sleep Terror (Promethazine Tooth Abscess Hydrochloride) C Urinary Tract Infection Inderal (Propranolol Vomiting Hydrochloride) C Weight Increased Sinequan (Doxepin Hydrochloride) C Cholestyramine Resin C Benadryl C Valirum (Diazepam) C Zyrtec (Cetirizine Hydrochloride) C Satadol (Butorphanol Tartrate) C Nortriptyline C Trazodone C Sumatriptan C Nasarel (Flunisolide) C Flovent (Fluticasone 24-Jun-2005 12:19 PM Page: 3489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propionate0 C Gentamicin C Risperidone C Ultram (Tramadol Hydrochloride) C Albuterol C Flextra-De C Guaifenex C Pravastatin C Cyclobenzaprine C Sulfamethoxazole C Orlistat C Rizatriptan C Histex C Zithromax (Azithromycin) C Acetaminophen W/Hydrocodone C Propoxyphene C Prevacid (Lansoprazole) C Zoloft (Sertraline Hydrochloride) C Claritin-D C Dolgic Lq C Imodium (Loperamide Hydrochloride) C Cataflam (Diclofenac Potassium) C Pravachol (Pravastatin Sodium) C Date:03/09/05ISR Number: 4606912-8Report Type:Expedited (15-DaCompany Report #US_0501109957 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zyprexa-Oral Initial or Prolonged Depression (Olanzapine) PS Other Hand Fracture Paxil (Paroxetine Liver Disorder Hydrochloride) C Neuropathy Neurontin Pancreatitis (Gabapentin) C Panic Attack Methadone C Personality Disorder Vitamins Nos C Polysubstance Dependence Protonix Road Traffic Accident (Pantoprazole) C Date:03/09/05ISR Number: 4606914-1Report Type:Expedited (15-DaCompany Report #US_0404102096 Age: Gender:Male I/FU:F Outcome PT Life-Threatening Blood Alkaline Hospitalization - Phosphatase Increased Initial or Prolonged Blood Cholesterol Disability Increased Brain Damage Cognitive Disorder Compulsions Dependent Personality Disorder 24-Jun-2005 12:19 PM Page: 3490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressed Mood Drug Dependence Drug Tolerance Decreased Report Source Product Role Manufacturer Route Dose Duration Emotional Disorder Consumer Zyprexa-Oral Extrapyramidal Disorder Health (Olanzapine) PS 20 MG/ 1 AT Glucose Tolerance Test Professional BEDTIME Abnormal Prozac-Oral Hyperphagia (Fluoxetine) Hypertriglyceridaemia (Fluoxetine Memory Impairment Hydrochloride) SS Neuroleptic Malignant Luvox (Fluvoxamine Syndrome Maleate) C Obsessive Thoughts Zoloft (Sertraline Panic Attack Hydrochloride) C Skin Laceration Paxil (Paroxetine Tardive Dyskinesia Hydrochloride) C Weight Increased Xanax (Alprazolam Dum) C Buspar (Buspirone Hydrochloride) C Seroquel(Quetiapine Fumarate) C Celexa(Citalopram Hydrobromide) C Ativan (Lorazepam) C Zantac(Ranitidine Hydrochloride) C Reglan(Metoclopramid e Hydrochloride) C Prilosec(Omeprazole Ratiopharm) C Acetaminophen C Darvocet-N 100 C Phenergan(Promethazi ne Hydrochloride) C Ancef(Cefazolin Sodium) C Morphine C Codeine C Lexapro(Escitalopram Oxalate) C Zanaflex (Tizanidine Hydrochloride) C Tegretol (Carbamazepine Rivopharm) C Klonopin (Clonazepam) C Vitamin E C Protonix (Pantoprazole) C Wellbutrin (Bupropion Hydrochloride) C Hyoscyamine C Robinul (Glycopyrronium Bromide) C Ambien (Zolpidem Tartrate) C Baclofen C 24-Jun-2005 12:19 PM Page: 3491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4606915-3Report Type:Expedited (15-DaCompany Report #US_0412109481 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Accidental Overdose Health (Olanzapine) PS 10 MG AT Other Anorexia Professional BEDTIME Anxiety Cymbalta (Duloxetine Aortic Valve Incompetence Hydrochloride) SS Blood Albumin Decreased Prozac-Oral Blood Triglycerides (Fluoxetine) Increased (Fluoxetine Decreased Appetite Hydrochloride) SS 40 MG IN THE Dehydration MORNING Depression Lexapro Dermatitis Contact (Escitalopram Hepatic Enzyme Abnormal Oxalate) C Herpes Simplex Trazodone C Irritability Vistaril Joint Swelling (Hydroxyzine Malnutrition Embonate) C Nail Disorder Atenolol C Nausea Hydrocet C Pancreatitis Esgic-Plus C Periorbital Oedema Ranitidine C Pruritus Phenergan Pyoderma (Promethazine Vomiting Hydrochloride) C Weight Decreased Alprazolam C Reglan (Metoclopramide Hydrochloride) C Remeron (Mirtazapine Orifarm) C Neurontin (Gabapentin) C Norco C Phrenilin Forte C Ultram (Tramadol Hydrochloride) C Lortab C Date:03/09/05ISR Number: 4606940-2Report Type:Expedited (15-DaCompany Report #US_0410106706 Age:30 YR Gender:Male I/FU:I Outcome PT Death Diabetes Mellitus Hospitalization - Diabetic Coma Initial or Prolonged Diabetic Ketoacidosis Other Disturbance In Attention Emotional Distress Flashback Hyperglycaemia Hypertension Legal Problem Mental Disorder Metabolic Syndrome Obesity Pancreatitis Panic Attack Pressure Of Speech 24-Jun-2005 12:19 PM Page: 3492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Road Traffic Accident Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Trismus Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 15 MG Zyprexa-Dispersible (Olanzapine) (Olanzapine) SS 15 MG/TID Paxil (Paroxetine Hydrochloride) C Insulin C Xanax (Alprazolam Dum) C Halcion (Triazolam) C Haldol (Haloperidol Decanoate) C Lithium C Prevacid (Lansoprazole) C Augmentin C Vicoprofen C Cogentin(Benzatropin e Mesilate) C Prolixin (Fluphenazine Hydrochloride) C Date:03/09/05ISR Number: 4607002-0Report Type:Expedited (15-DaCompany Report #US-0503113696 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Study Olanzapine-Oral Initial or Prolonged Hypercalcaemia Health (Olanzapine) PS Hyperkalaemia Professional Bifeprunox SS Hyponatraemia Multivitamin C Inappropriate Antidiuretic Hormone Secretion Date:03/09/05ISR Number: 4607013-5Report Type:Expedited (15-DaCompany Report #USA050291391 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa Initial or Prolonged Increased Professional Zydis-Dispersible Other Aspartate Company (Olanzapine) Aminotransferase Representative (Olanzapine) PS 30 MG DAY Increased Depakote (Valproate Bipolar Disorder Semisodium) C Schizoaffective Disorder Abilify Weight Increased (Aripiprazole) C 24-Jun-2005 12:19 PM Page: 3493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4607034-2Report Type:Expedited (15-DaCompany Report #US_030493862 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Consumer Zyprexa-Oral Initial or Prolonged Anaemia Health (Olanzapine) Other Asthma Professional (Olanzapine) PS 5 MG AT Atelectasis BEDTIME Bacteraemia Zestril (Lisinopril) C Blood Potassium Increased Zoloft (Sertraline Cataract Hydrochloride) C Coma Aspirin C Cystitis Desyrel (Trazodone Diabetes Mellitus Hydrochloride) C Inadequate Control Vioxx (Rofecoxib) C Diarrhoea Lopressor Dyspepsia (Metoprolol Hepatic Steatosis Tartrate) C Hypernatraemia Celebrex (Celecoxib) C Hypoaesthesia Combivent C Hypokalaemia Pepcid (Famotidine) C Laryngotracheo Bronchitis Ultram (Tramadol Metabolic Encephalopathy Hydrochloride) C Neuropathy Trazadone Pancreatitis Acute (Trazadone) C Plantar Fasciitis Vistaril Pneumonia (Hydroxyzine Renal Failure Acute Embonate) C Respiratory Failure Restoril (Temazepam) C Rhabdomyolysis Flovent (Fluticasone Sputum Culture Positive Propionate) C Staphylococcal Infection Ventolin (Salbutamol Systemic Inflammatory Sulfate) C Response Syndrome Combivent C Tachycardia Singulair Thrombocytopenia (Montelukast) C Urinary Tract Infection Fungal Vaginal Infection Date:03/09/05ISR Number: 4607036-6Report Type:Expedited (15-DaCompany Report #USA050290890 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Zyprexa-Oral Increased Professional (Olanzapine) Insomnia Company (Olanzapine) PS Representative Date:03/09/05ISR Number: 4607521-7Report Type:Expedited (15-DaCompany Report #US_0502112390 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Rapid-Acting Hospitalization - Drug Toxicity Health Im (Olanzapine) PS Initial or Prolonged Hypotension Professional Midazolam C Company Diazepam C Representative 24-Jun-2005 12:19 PM Page: 3494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4607685-5Report Type:Expedited (15-DaCompany Report #DE_050215300 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Zyprexa-Oral Other Dystonia Health (Olanzapine) General Physical Health Professional (Olanzapine) PS 5 MG DAY Deterioration Other Beloc Zok Lung Disorder (Metoprolol Pleurothotonus Succinate) C Pneumonia Lasix (Furosemide) C Pulmonary Embolism Ergenyl (Valproate Sodium) C Cipramil (Citalopram Hydrochloride) C Bromuc (Acetylcysteine M/G) C Clexane (Enoxaparin Sodium) C Mucosolvan (Ambroxol Hydrochloride) C Date:03/09/05ISR Number: 4607686-7Report Type:Expedited (15-DaCompany Report #DE_050215295 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 15 MG DAY Aminotransferase Other Remergil Increased (Mirtazapine Blood Lactate Orifarm) C Dehydrogenase Increased Risperdal Drug Interaction (Risperidone) C Drug Toxicity Tavor (Lorazepam) C Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Liver Disorder Date:03/09/05ISR Number: 4607688-0Report Type:Expedited (15-DaCompany Report #EWC050242889 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Face Oedema Foreign Zyprexa-Oral Oedema Peripheral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/ 1 DAY Company Representative Other Date:03/09/05ISR Number: 4608416-5Report Type:Expedited (15-DaCompany Report #FR_050205764 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Other Gastrointestinal Foreign Haemorrhage Health Professional Company 24-Jun-2005 12:19 PM Page: 3495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) PS 20 MG/1 DAY Date:03/09/05ISR Number: 4608417-7Report Type:Expedited (15-DaCompany Report #FR_050205765 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Foreign Zyprexa-Oral Haemorrhage Health (Olanzapine) Oesophageal Varices Professional (Olanzapine) PS 20 MG/1 DAY Haemorrhage Company Lysankia (Prazepam) C Representative Other Date:03/09/05ISR Number: 4608418-9Report Type:Expedited (15-DaCompany Report #DE_030511317 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Zyprexa Velotab-Oral Initial or Prolonged Aminotransferase Literature (Olanzapine) PS 10 MG IN THE Increased Health EVENING Drug Screen Positive Professional Rhabdomyolysis Other Date:03/09/05ISR Number: 4608727-3Report Type:Expedited (15-DaCompany Report #US_0502113292 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Event Foreign Zyprexa-Oral Feeling Abnormal Consumer (Olanzapine) Company (Olanzapine) PS 10 MG DAY Representative Other Date:03/09/05ISR Number: 4608728-5Report Type:Expedited (15-DaCompany Report #GBS050216746 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 20 MG Hypertriglyceridaemia Professional Zopiclone Xanthoma Other (Zopiclone) C Date:03/09/05ISR Number: 4608729-7Report Type:Expedited (15-DaCompany Report #FR_050205903 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Hyperthermia Malignant Health (Olanzapine) Neuroleptic Malignant Professional (Olanzapine) PS 20 MG DAY Syndrome Other Neutropenia Thrombocytopenia 24-Jun-2005 12:19 PM Page: 3496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4608730-3Report Type:Expedited (15-DaCompany Report #FR_050205913 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Guillain-Barre Syndrome Foreign Zyprexa-Oral Initial or Prolonged Influenza Health (Olanzapine) Quadriparesis Professional (Olanzapine) PS Other Praxinor C Parkinane (Trihexyphenidyl Hydrochloride) C Havlane (Loprazolam Mesilate) C Date:03/09/05ISR Number: 4608731-5Report Type:Expedited (15-DaCompany Report #DE_050215277 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disease Recurrence Foreign Zyprexa-Oral Granulocyte Count Health (Olanzapine) Decreased Professional (Olanzapine) PS 10 MG DAY Infection Other Influenza Like Illness Lymphocyte Count Increased Platelet Count Decreased Schizophrenia White Blood Cell Count Decreased Date:03/09/05ISR Number: 4608735-2Report Type:Expedited (15-DaCompany Report #FR_050205766 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Foreign Zyprexa-Oral Haemorrhage Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Company Representative Other Date:03/09/05ISR Number: 4608736-4Report Type:Expedited (15-DaCompany Report #GBS050216652 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Intentional Misuse Health (Olanzapine) Professional (Olanzapine) PS Company Risperidone C Representative Clopixol Other (Zuclopenthixol) C Cannabis C Dextroamphetamine (Dexamfetamine) C 24-Jun-2005 12:19 PM Page: 3497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/05ISR Number: 4608377-9Report Type:Direct Company Report #CTU 242958 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperlipidaemia Zyprexa 25mg Po 1 Pm PS ORAL 25 MG PO QPM Zyprexa SS Date:03/11/05ISR Number: 4608926-0Report Type:Expedited (15-DaCompany Report #2005-126050-NL Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Mirtazapine PS ORAL 30 MG 15 DAY Injury Asphyxiation Olanzapine SS ORAL 7.5 MG 50 DAY Date:03/14/05ISR Number: 4606967-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050300757 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Haldol PS Syndrome Haldol SS Pleurothotonus Zyprexa SS Zyprexa SS start date: since months Tavor C Tavor C Tavor C start date: since weeks Climopax C Climopax C 0.625/5mg start date: since months Euthyrox C start date: since months Felis C start date: since weeks Date:03/14/05ISR Number: 4609165-XReport Type:Expedited (15-DaCompany Report #DSA_25989_2005 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Tavor PS 1 MG Q DAY Initial or Prolonged Drug Interaction Health Saroten "Bayer Dry Mouth Professional Vital" SS Bayer Vital 125 MG Q DAY Tremor Other Zyprexa SS 5 MG Q DAY Date:03/14/05ISR Number: 4609382-9Report Type:Expedited (15-DaCompany Report #A044-002-005325 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Aricept (Donepezil Initial or Prolonged Disturbance In Attention Health Hydrochloride) PS ORAL 1 IN 1D, ORAL Hyponatraemia Professional Laroxyl Muscle Rigidity (Amitriptyine Hydrochloride) SS ORAL ORAL Xanax (Alprazolam) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Deroxat (Paroxetine 24-Jun-2005 12:19 PM Page: 3498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL ORAL Zestoretic (Prinizide) C Inipomp (Pantoprazole) C Date:03/14/05ISR Number: 4609771-2Report Type:Direct Company Report #CTU 243136 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Zyprexa PS Initial or Prolonged Hypoaesthesia Risperdal , 0.50 Disability Insomnia Mg/Ml SS EVERY TWO WKS Other Libido Disorder BY INJ Nail Disorder Weight Increased Date:03/14/05ISR Number: 4609851-1Report Type:Direct Company Report #CTU 243175 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Zyprexa PS ORAL SEE IMAGE Diabetic Ketoacidosis Feeling Abnormal Nausea Respiratory Distress Sudden Death Vomiting Date:03/15/05ISR Number: 4608468-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0406391A Age: Gender:Male I/FU:F Outcome PT Other Acquired Porphyria Aggression Agitation Akathisia Amnesia Arthralgia Asthenia Bipolar Disorder Body Temperature Fluctuation Convulsion Coordination Abnormal Crying Depression Disability Dizziness Dysarthria Dysphemia Dyspnoea Electric Shock Emotional Disorder Encephalopathy Facial Palsy Fatigue Feeling Abnormal Hair Metal Test Abnormal 24-Jun-2005 12:19 PM Page: 3499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Head Banging Headache Hyperaesthesia Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Wellbutrin PS Glaxosmithkline ORAL 42 DAY Hypoxia Tranquilizer SS Immune System Disorder Depakote SS Injury Zyprexa SS Insomnia Alcohol C Intentional Self-Injury Mania Mastocytosis Metabolic Encephalopathy Multiple Chemical Sensitivity Muscle Spasms Myalgia Myoclonus Nervous System Disorder Nightmare Overdose Pain Of Skin Petit Mal Epilepsy Schizoaffective Disorder Suicidal Ideation Suicide Attempt Throat Tightness Tremor Vestibular Disorder Vomiting Date:03/15/05ISR Number: 4608752-2Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200500181 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphonia Plavix PS ORAL Initial or Prolonged Blood Alkaline Temesta SS ORAL Phosphatase Increased Allopurinol SS ORAL Cerebral Atrophy Zyprexa SS ORAL Csf Protein Increased Mectizan SS ORAL UNK Disorientation Imovane C ORAL UNK Encephalopathy Zocor C ORAL UNK Eosinophil Count Increased Hallucination, Visual Hyperreflexia Myoclonus Date:03/15/05ISR Number: 4610940-6Report Type:Direct Company Report #CTU 243255 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Olanzapine PS Lilly ORAL 15MG HS ORAL Initial or Prolonged Dysarthria Trazodone C Required Temazepam C Intervention to Gabapentin C Prevent Permanent Lithium Carbonate C Impairment/Damage Benztropine C 24-Jun-2005 12:19 PM Page: 3500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/05ISR Number: 4613310-XReport Type:Expedited (15-DaCompany Report #EWC050343018 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Scan Abnormal Foreign Zyprexa Oral Loss Of Consciousness Consumer (Olanzapine)(Olanzap Syncope Other ine) PS 20 MG/1 DAY Date:03/15/05ISR Number: 4613311-1Report Type:Expedited (15-DaCompany Report #AU_050308416 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa Oral Health (Olanzapine)(Olanzap Professional ine) PS Company Representative Other Date:03/15/05ISR Number: 4614135-1Report Type:Expedited (15-DaCompany Report #USA050291560 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/15/05ISR Number: 4614138-7Report Type:Expedited (15-DaCompany Report #US_0410106934 Age:35 YR Gender:Female I/FU:I Outcome PT Other Amnesia Arthritis Cardiac Disorder Coordination Abnormal Depression Diabetes Mellitus Difficulty In Walking Granuloma Hallucination, Auditory Hyperinsulinism Hypoaesthesia Hypoaesthesia Oral Iatrogenic Injury Increased Appetite Infection Influenza Intentional Self-Injury Motor Dysfunction Oedema Peripheral Pelvic Inflammatory Disease Post Procedural Complication Prescribed Overdose Self Mutilation Smear Cervix Abnormal Suicidal Ideation Thyroid Disorder 24-Jun-2005 12:19 PM Page: 3501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Urinary Tract Infection Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 25 MG DAY Prozac (Fluoxetine Hydrochloride) C Promethazine C Doxycycline C Lorazepam C Topamax (Topiramate) C Verapamil C Synthroid (Levothyroxine Sodium) C Lustra Cream C Cylert (Pemoline Magnesium) C Prilosec (Omeprazole Ratiopharm) C Novahistine Elixir C Hydrocodone W/Apap C Phentermine C Lorcet Plus C Avita (Tretinoin) C Bromphen Dc C Loestrin Fe C Neurontin (Gabapentin Pfizer) C Buspar (Buspirone H Ydrochloride) C Dyazide C Axid (Nizatidine) C Gabitril (Tiagabine Hydrochloride) C Navane (Tiotixene) C Inderal (Propranolol Hydrochloride) C Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Prevacid (Lansoprazole) C Date:03/15/05ISR Number: 4614218-6Report Type:Expedited (15-DaCompany Report #US_0412109481 Age:39 YR Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Overdose Initial or Prolonged Anxiety Other Aortic Valve Incompetence Blood Albumin Decreased Body Temperature Decreased Decreased Appetite Dehydration 24-Jun-2005 12:19 PM Page: 3502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Dermatitis Contact Hepatic Enzyme Abnormal Report Source Product Role Manufacturer Route Dose Duration Herpes Simplex Consumer Zyprexa-Oral Hypokalaemia Health (Olanzapine) Intentional Misuse Professional (Olanzapine) PS 10 MG AT Intentional Self-Injury BEDTIME Irritability Cymbalta (Duloxetine Joint Swelling Hydrochloride) SS Malnutrition Prozac-Oral Nausea (Fluoxetine) Pancreatitis (Fluoxetine Periorbital Oedema Hydrochloride) SS 40 MG IN THE Pruritus MORNING Pyoderma Lexapro Self Injurious Behaviour (Escitalopram Skin Lesion Oxalate) C Suicide Attempt Trazodone C Swollen Tongue Vistaril Thermal Burn (Hydroxyzine Vomiting Embonate) C Weight Decreased Atenolol C Weight Increased Hydrocet C Wound Secretion Esgic-Plus C Ranitidine C Phenergan (Promethazine Hydrochloride) C Alprazolam C Reglan (Metoclopramide Hydrochloride) C Remeron (Mirtazapine Orifarm) C Neurontin (Gabapentin Prizer) C Norco C Phrenilin Forte C Ultram (Tramadol Hydrochloride) C Lortab C Quinine C Lasilix (Furosemide) C Klonopin (Clonazepam) C Xanax (Alprazolam Dum) C Zebutal C Date:03/15/05ISR Number: 4614229-0Report Type:Expedited (15-DaCompany Report #20050200047 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Ativan (Lorazepam) PS Baxter 1 MG QD Initial or Prolonged Drug Interaction Health Saroten Dry Mouth Professional (Amitriptyline Tremor Other Hydrochloride) SS 125 MG QD Zyprexa (Olanzapine) SS 5 MG QD 24-Jun-2005 12:19 PM Page: 3503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/05ISR Number: 4614232-0Report Type:Expedited (15-DaCompany Report #US_0503113818 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Diabetic Coma (Olanzapine) Diabetic Ketoacidosis (Olanzapine) PS Date:03/15/05ISR Number: 4614235-6Report Type:Expedited (15-DaCompany Report #US_0502113333 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/15/05ISR Number: 4614240-XReport Type:Expedited (15-DaCompany Report #US_0503113814 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/15/05ISR Number: 4614280-0Report Type:Expedited (15-DaCompany Report #USA050291783 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcohol Use Consumer Cymbalta (Duloxetine Amnesia Hydrochloride) PS 60 MG/2 DAY Loss Of Consciousness Zyprexa-Oral (Olanzapine) (Olanzapine) SS Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 10 MG Neurontin (Gabapentin Pfizer) C Pfizer Restoril (Temazepam) C Seroquel (Quetiapine Fumarate) C Date:03/15/05ISR Number: 4614290-3Report Type:Expedited (15-DaCompany Report #US_0502111957 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystocele Consumer Zyprexa Oral Initial or Prolonged Rectocele Health (Olanzapine)(Olanzap Urinary Incontinence Professional ine) PS 20 MG Symbyax C Alprazolam C Wellbutrin (Bupropion Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Trazadone 24-Jun-2005 12:19 PM Page: 3504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Trazodone) C Amaryl (Glimepiride) C Tenormin (Atenolol Eg) C Date:03/15/05ISR Number: 4614293-9Report Type:Expedited (15-DaCompany Report #US_0503113852 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) PS Date:03/15/05ISR Number: 4614302-7Report Type:Expedited (15-DaCompany Report #USA040977233 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Drug Ineffective (Olanzapine) PS 15 MG Other Fatigue Zyprexa-Disperisble Hangover (Olanzapine) SS 30 MG DAY Loss Of Consciousness Abilify Palpitations (Airipiprazole) C Prescribed Overdose Depakote (Valproate Respiratory Failure Semisodium) C Sensory Loss Depakene (Valproate Treatment Noncompliance Sodium) C Tremor Klonopin (Clonazepam) C Celebrex (Celecoxib) C Date:03/15/05ISR Number: 4614371-4Report Type:Expedited (15-DaCompany Report #8009200 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Areflexia Foreign Keppra PS Initial or Prolonged Coma Health Keppra SS ORAL 140000 MG Other Haemodialysis Professional ONCE PO Hypotension Other Olanzapine SS ORAL 500 MG ONCE Intentional Misuse PO Medical Device Diazepam SS ORAL ONCE PO Complication Obstruction Somnolence Suicide Attempt Tachycardia Date:03/15/05ISR Number: 4615143-7Report Type:Expedited (15-DaCompany Report #US_0411107577 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Hysterectomy (Olanzapine) Injury (Olanzapine) PS Weight Increased Olanzipine/Fluoxetin e C Quetiapine C Ziprasidone C Haldol (Haloperidol 24-Jun-2005 12:19 PM Page: 3505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decanoate) C Divalproex Sodium C Bupropion C Citalopram Hydrobromide C Glipizide C Glyburide W/Metformin C Date:03/15/05ISR Number: 4615145-0Report Type:Expedited (15-DaCompany Report #US_0503113780 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Abnormal (Olanzapine) Other Blood Triglycerides (Olanzapine) PS 10 MG DAY Increased Symbyax-Olanzapine / Diabetes Mellitus Fluoxetine (Ola SS Hyperglycaemic Mirtazapine C Hyperosmolar Nonketotic Glipizide C Syndrome Mumps Neuropathy Vision Blurred Date:03/15/05ISR Number: 4615149-8Report Type:Expedited (15-DaCompany Report #US_0404102096 Age: Gender:Male I/FU:F Outcome PT Life-Threatening Affect Lability Hospitalization - Anxiety Initial or Prolonged Blood Alkaline Disability Phosphatase Increased Blood Cholesterol Increased Blood Glucose Increased Blood Triglycerides Increased Brain Damage Cognitive Disorder Dependent Personality Disorder Depressed Mood Disturbance In Social Behaviour Drug Dependence Drug Hypersensitivity Emotional Disorder Extrapyramidal Disorder Fear Glucose Tolerance Test Abnormal Hyperphagia Memory Impairment Morbid Thoughts Nervousness Neuroleptic Malignant Syndrome Sedation Skin Laceration 24-Jun-2005 12:19 PM Page: 3506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tardive Dyskinesia Thinking Abnormal Vomiting Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG/ 1 AT BEDTIME Prozac - Oral(Fluoxetine) (Fluoxetine Hydrochloride) SS Luvox (Fluvoxamine Maleate) C Zoloft (Sertraline Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Xanax (Alprazolam Dum) C Buspar (Buspirone Hydrochloride) C Seroquel (Quetiapine Fumarate) C Celexa (Citalopram Hydrobromide) C Ativan (Lorazepam) C Zantac (Ranitidine Hydrochloride) C Reglan (Metoclopramide Hydrochloride) C Prilosec (Omeprazole) C Acetaminophen C Darvocet-N 100 C Phenergan (Promethazine Hydrochloride) C Ancef (Cefazolin Sodium) C Morphine C Codeine C Lexapro (Escitalopram Oxalate) C Tegretol (Carbamazepine) C Klonopin (Clonazepam) C Vitamin E C Protonix (Pantoprazole) C Wellbutrin (Bupropion Hydrochloride) C Hyoscyamine C Robinul (Glycopyrronium Bromide) C Ambien (Zolpidem Tartrate) C 24-Jun-2005 12:19 PM Page: 3507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Baclofen C Lithium C Trihexyphenidyl Hydrochloride) C Date:03/15/05ISR Number: 4615157-7Report Type:Expedited (15-DaCompany Report #US_0503113812 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Zyprexa-Oral Cardio-Respiratory Arrest Health (Olanzapine) Drug Toxicity Professional (Olanzapine) PS Multiple Drug Overdose Amphetamine C Marijuana C Date:03/15/05ISR Number: 4615159-0Report Type:Expedited (15-DaCompany Report #US_0503113802 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Zyprexa-Oral Completed Suicide Health (Olanzapine) Intentional Misuse Professional (Olanzapine) PS Amitriptyline C Date:03/15/05ISR Number: 4615185-1Report Type:Expedited (15-DaCompany Report #US_0503113810 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Multiple Drug Overdose Health (Olanzapine) Professional (Olanzapine) PS Fluoxetine Hydrochloride-Oral (Fluoxetine) SS Quetiapine C Date:03/15/05ISR Number: 4615194-2Report Type:Expedited (15-DaCompany Report #US_0503113808 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Zyprexa-Oral Completed Suicide Health (Olanzapine) Multiple Drug Overdose Professional (Olanzapine) PS Respiratory Arrest Ziprasidone C Clonazepam C Date:03/15/05ISR Number: 4615195-4Report Type:Expedited (15-DaCompany Report #US_0503113798 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Multiple Drug Overdose Health (Olanzapine) Professional (Olanzapine) PS Acetaminophen C 24-Jun-2005 12:19 PM Page: 3508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/05ISR Number: 4615199-1Report Type:Expedited (15-DaCompany Report #US_0503113748 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Zyprexa-Oral Multiple Drug Overdose Health (Olanzapine) Professional (Olanzapine) PS Acetaminophen W/Oxycodone C Methadone C Date:03/15/05ISR Number: 4615202-9Report Type:Expedited (15-DaCompany Report #US_0503113745 Age:62 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Multiple Drug Overdose Health (Olanzapine) Professional (Olanzapine) PS Acetaminophen W/Hydrocodone C Opioid C Date:03/16/05ISR Number: 4609674-3Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0538024A Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Wellbutrin Xl PS Glaxosmithkline ORAL 150MG Per day 5 DAY Initial or Prolonged Incontinence Symbyax SS 30 DAY Loss Of Consciousness Birth Control Pills C Sexual Dysfunction Date:03/16/05ISR Number: 4610088-0Report Type:Expedited (15-DaCompany Report #AU-SANOFI-SYNTHELABO-A01200501373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Stilnox PS ORAL UNK Hepatic Steatosis Zyprexa SS ORAL 10 mg 17 DAY Risperidone SS INTRAMUSCULAR UNK 54 DAY Mirtazapine SS ORAL UNK Date:03/16/05ISR Number: 4611858-5Report Type:Expedited (15-DaCompany Report #US_0502112386 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Zyprexa-Oral Injury Asphyxiation Health (Olanzapine) Professional (Olanzapine) PS 20 MG Company Representative Date:03/16/05ISR Number: 4612199-2Report Type:Expedited (15-DaCompany Report #US_0503113788 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Intentional Misuse Health (Olanzapine) Professional (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C Aripiprazole C Date:03/16/05ISR Number: 4612200-6Report Type:Expedited (15-DaCompany Report #US_0503113741 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Intentional Misuse Health (Olanzapine) Professional (Olanzapine) PS Acetaminophen C Buspirone C Date:03/16/05ISR Number: 4612217-1Report Type:Expedited (15-DaCompany Report #US_0503113805 Age:67 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Chlorpromazine C Date:03/16/05ISR Number: 4612219-5Report Type:Expedited (15-DaCompany Report #US_0503113735 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Intentional Misuse Health (Olanzapine) Professional (Olanzapine) PS Acetaminophen C Date:03/16/05ISR Number: 4612221-3Report Type:Expedited (15-DaCompany Report #US_0503113755 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Intentional Misuse Health (Olanzapine) Professional (Olanzapine) PS Aspirin (Acetylsalicylic Acid) C Acetylsalicylate C Date:03/16/05ISR Number: 4612223-7Report Type:Expedited (15-DaCompany Report #US_0503113751 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa-Oral Intentional Misuse Health (Olanzapine) Professional (Olanzapine) PS Acetaminophen W/Propoxyphene C Diphenhydramine C 24-Jun-2005 12:19 PM Page: 3510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4612225-0Report Type:Expedited (15-DaCompany Report #US_0503113803 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Consumer Zyprexa-Oral Anxiety (Olanzapine) Conversion Disorder (Olanzapine) PS Delusion Paxil (Paroxetine Gun Shot Wound Hydrochloride) C Head Injury Intentional Self-Injury Paranoia Date:03/16/05ISR Number: 4612234-1Report Type:Expedited (15-DaCompany Report #US_0503113792 Age:56 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa Intentional Misuse Health (Olanzapine) PS Professional Amlodipine C Zolpidem C Date:03/16/05ISR Number: 4612238-9Report Type:Expedited (15-DaCompany Report #US_0503113770 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Literature Zyprexa Overdose Health (Olanzapine) PS ORAL Respiratory Arrest Professional Methadone C Alprazolam C Olanzapine C Date:03/16/05ISR Number: 4612239-0Report Type:Expedited (15-DaCompany Report #US_0503113781 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Zyprexa PS ORAL Completed Suicide Health Propoxyphene C Intentional Misuse Professional Cocaine C Norpropoxyphene C Benzoylegonine (Cocaine Metabolite) C Olanzapine C Date:03/16/05ISR Number: 4612241-9Report Type:Expedited (15-DaCompany Report #US_0503113785 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Zyprexa Completed Suicide Health (Olanzapine) PS ORAL Professional Lithium C Venlafaxine C 24-Jun-2005 12:19 PM Page: 3511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4612244-4Report Type:Expedited (15-DaCompany Report #US_0503113807 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zyprexa Intentional Misuse Health (Olanzapine) PS ORAL Professional Triamterene C Hydroxyzine C Date:03/16/05ISR Number: 4612258-4Report Type:Expedited (15-DaCompany Report #US_0410106336 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorectal Disorder Consumer Zyprexa-Oral Chronic Obstructive Health (Olanzapine) Pulmonary Disease Professional (Olanzapine) PS 15 MG AT Diabetes Mellitus BEDTIME Insulin-Dependent Topamax (Topiramate) C Diabetic Neuropathy Quetiapine C Glycosuria Risperidone C Haematuria Depakote (Valproate Hypercholesterolaemia Semisodium) C Hypertension Lipitor Hypoglycaemia (Atorvastatin Ketoacidosis Calcium) C Oedema Peripheral Prilosec (Omeprazole Onychomycosis Ratiopharm) C Pancreatitis Rectal Haemorrhage Treatment Noncompliance Date:03/16/05ISR Number: 4612260-2Report Type:Expedited (15-DaCompany Report #USA050392189 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Health Zyprexa-Oral Hospitalization - Professional (Olanzapine) Initial or Prolonged (Olanzapine) PS 40 MG DAY Other Xanax (Alprazolam Dum) C Date:03/16/05ISR Number: 4612263-8Report Type:Expedited (15-DaCompany Report #USA050392194 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:03/16/05ISR Number: 4612312-7Report Type:Expedited (15-DaCompany Report #USA050392037 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative 24-Jun-2005 12:19 PM Page: 3512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4612314-0Report Type:Expedited (15-DaCompany Report #USA050291922 Age:98 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) PS Date:03/16/05ISR Number: 4612316-4Report Type:Expedited (15-DaCompany Report #USA050392482 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa-Oral Initial or Prolonged Gravitational Oedema Professional (Olanzapine) PS 15 MG DAY Other Insomnia Prozac (Fluoxetine Pulmonary Oedema Hydrochloride) C Date:03/16/05ISR Number: 4612331-0Report Type:Expedited (15-DaCompany Report #USA050392269 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Symbax-Olanzapine Extrapyramidal Disorder Professional 12mg/Fluoxetine Company 25mg(Olanzapi PS Representative Amantadine C Date:03/16/05ISR Number: 4612423-6Report Type:Expedited (15-DaCompany Report #US_0412109210 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa- Oral Insulin-Dependent (Olanzapine) PS 20 MON Hepatic Failure Hepatic Steatosis Pancreatitis Date:03/16/05ISR Number: 4612424-8Report Type:Expedited (15-DaCompany Report #USA041080355 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Zyprexa-Oral Initial or Prolonged Consciousness Professional (Olanzapine) PS 2.5 MG/2 DAY 2 MON Other Drug Interaction Tylenol Pm C Lethargy Furosmeide (Furosemide) C Pravachol (Pravastatin Sodium) C Potassium Chloride C Date:03/16/05ISR Number: 4612640-5Report Type:Direct Company Report #CTU 243411 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Zyprexa PS Eli Lilly QHS Initial or Prolonged Insulin-Dependent Diabetic Ketoacidosis Hypertriglyceridaemia 24-Jun-2005 12:19 PM Page: 3513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4613164-1Report Type:Expedited (15-DaCompany Report #USA030948579 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa Oral Initial or Prolonged Angiopathy (Olanzapine)(Olanzap Blood Cholesterol ine) PS 10 MG DAY 3 WK Increased Synthroid Gallbladder Disorder (Levothyroxine Gamma-Glutamyltransferase Sodium) C Increased Ambien (Zolpidem High Density Lipoprotein Tartrate) C Increased Low Density Lipoprotein Increased Malaise Renal Pain Weight Increased Date:03/16/05ISR Number: 4613885-0Report Type:Expedited (15-DaCompany Report #6012939 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Disorder Health Euthyrox Initial or Prolonged Transaminases Increased Professional (Levothyroxine Other Sodium) PS 125 MCG Hypnorex (Lithium Carbonate) SS SEE IMAGE 69 DAY Amineurin (Amitriptyline Hydrochloride) SS SEE IMAGE 60 DAY Tavor (Lorazepam) SS SEE IMAGE 27 DAY Truxal (Chlorporthixene Hydrochloride) SS SEE IMAGE 1 DAY Zyprexa (Olanzapine) SS SEE IMAGE 1 DAY Lasix (Furosemide) SS 20 MG Date:03/16/05ISR Number: 4614029-1Report Type:Expedited (15-DaCompany Report #JP_050105691 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Foreign Zyprexa-Oral Ventricular Extrasystoles Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Depas (Etizolam) C Representative Gasmotin (Mosapride Other Citrate) C Magmitt (Magnesium Oxide) C Date:03/16/05ISR Number: 4614036-9Report Type:Expedited (15-DaCompany Report #AU_050308405 Age:33 YR Gender:Female I/FU:I Outcome PT Arthralgia Joint Swelling Overdose Purpura 24-Jun-2005 12:19 PM Page: 3514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vasculitis Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 5 MG/ONCE DAY 1 WK Professional Propylthioracil C Company Paroxetine C Representative Zopiclone Other (Zopiclone) C Date:03/16/05ISR Number: 4614039-4Report Type:Expedited (15-DaCompany Report #FR_030602519 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zyprexa-Oral Initial or Prolonged Caesarean Section Health (Olanzapine) Delirium Professional (Olanzapine) PS 10 MG/ DAY Drug Exposure During Other Augmentin C Pregnancy Loxen (Nicardipine Pre-Eclampsia Hydrochloride) C Premature Labour Ferrostrane (Sodium Pyrexia Feredetate) C Mag 2 (Magnesium Pidolate) C Date:03/16/05ISR Number: 4614040-0Report Type:Expedited (15-DaCompany Report #GBS050316789 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Injury Asphyxiation Health (Olanzapine) PS 7.5 MG DAY 50 DAY Professional Mirtazapine C Other Date:03/16/05ISR Number: 4614041-2Report Type:Expedited (15-DaCompany Report #GBS050116481 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS 15 MG DAY Heart Rate Increased Professional Valproate Sodium C Pyrexia Other Diazepam C Viral Infection Lorazepam C White Blood Cell Count Promethazine C Increased Date:03/16/05ISR Number: 4614042-4Report Type:Expedited (15-DaCompany Report #GBS050316809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Injury Asphyxiation Health (Olanzapine) PS 10 MG DAY Professional Venlafaxine C Other 24-Jun-2005 12:19 PM Page: 3515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4614043-6Report Type:Expedited (15-DaCompany Report #GBS050316806 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Zyprexa-Oral Dry Mouth Health (Olanzapine) Nasal Congestion Professional (Olanzapine) PS 15 MG Speech Disorder Other Seroxat (Paroxetine Tremor Hydrochloride) C Weight Increased Orlept (Valproate Sodium) C Date:03/16/05ISR Number: 4614046-1Report Type:Expedited (15-DaCompany Report #GBS041216119 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Artery Stenosis Foreign Olanzapine-Oral Hospitalization - Cerebral Artery Health (Olanzapine) PS 2.5 MG Initial or Prolonged Thrombosis Professional Paroxetine C Other Cerebrovascular Accident Other Circulatory Collapse Coronary Artery Occlusion Deep Vein Thrombosis Influenza Like Illness Lung Consolidation Myocardial Infarction Pulmonary Congestion Pulmonary Embolism Pulmonary Hypertension Pulmonary Oedema Date:03/16/05ISR Number: 4614049-7Report Type:Expedited (15-DaCompany Report #AU_050208402 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affective Disorder Foreign Olanzapine-Oral Initial or Prolonged Chest Pain Health (Olanzapine) PS 20 MG/ONCE AT Dyspnoea Professional BEDTIME Fluid Retention Other Lithium C Heart Rate Increased Hyperventilation Hypoventilation Joint Swelling Palpitations Psychotic Disorder Date:03/16/05ISR Number: 4614050-3Report Type:Expedited (15-DaCompany Report #EWC050342956 Age:26 YR Gender:Male I/FU:I Outcome PT Other Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Cholesterol Increased Blood Lactate Dehydrogenase Increased 24-Jun-2005 12:19 PM Page: 3516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eosinophil Count Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Study (Olanzapine) PS Health Professional Other Date:03/16/05ISR Number: 4614051-5Report Type:Expedited (15-DaCompany Report #AU_050308411 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autoimmune Thyroiditis Foreign Olanzapine-Oral Drug Toxicity Study (Olanzapine) PS 20 MG Hepatomegaly Health Zoloft (Sertraline Lower Respiratory Tract Professional Hydrochloride) C Infection Other Xanax (Alprazolam Pneumonia Dum) C Splenomegaly Lithium C Thyroxine (Levothyroxine Sodium) C Date:03/16/05ISR Number: 4614052-7Report Type:Expedited (15-DaCompany Report #EWC050342916 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Foreign Zyprexa-Oral Initial or Prolonged Central-Alveolar Health (Olanzapine) Hypoventilation Professional (Olanzapine) PS 20 MG/1 DAY Chronic Respiratory Company Failure Representative Pneumonia Other Date:03/16/05ISR Number: 4614053-9Report Type:Expedited (15-DaCompany Report #EWC050342922 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oral Initial or Prolonged Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 172.5 MG DAY Hypotension Company Overdose Representative Sedation Other Date:03/16/05ISR Number: 4614054-0Report Type:Expedited (15-DaCompany Report #EWC050342999 Age:34 YR Gender:Male I/FU:I Outcome PT Death Blood Thyroid Stimulating Hospitalization - Hormone Increased Initial or Prolonged Colitis Ischaemic Other Condition Aggravated Drug Toxicity Hypothyroidism Psychotic Disorder 24-Jun-2005 12:19 PM Page: 3517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Renal Failure Shock Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 30 MG DAY Company Topiramate C Representative Heparin C Other Aripiprazole C Date:03/16/05ISR Number: 4614058-8Report Type:Expedited (15-DaCompany Report #DSA_26045_2005 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Tavor PS INTRAVENOUS 12 MG QD IV Hospitalization - Electrocardiogram Health Depakine SS ORAL 1000 MG QD PO Initial or Prolonged Abnormal Professional Zyprexa SS ORAL 20 MG QD PO Loss Of Consciousness Other Kcl-Retard C Pursennid C En C Date:03/16/05ISR Number: 4614081-3Report Type:Expedited (15-DaCompany Report #EWC050242684 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Dispersible Conduction Disorder Health (Olanzapine) Prescribed Overdose Professional (Olanzapine) PS 10 MG/2 DAY Sudden Death Company Depakin Chrono Representative (Valproate Sodium) C Other Tavor (Lorazepam) C Kcl-Retard (Potassium Chloride) C Pursennid C En (Delorazepam) C Date:03/16/05ISR Number: 4614082-5Report Type:Expedited (15-DaCompany Report #CA_050107645 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Zyprexa-Oral Hospitalization - Fear Health (Olanzapine) Initial or Prolonged Status Epilepticus Professional (Olanzapine) PS 10 MG Other Company Paxil (Paroxetine Representative Hydrochloride) C Other Date:03/16/05ISR Number: 4614083-7Report Type:Expedited (15-DaCompany Report #JP_041105135 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Foreign Zyprexa-Oral Initial or Prolonged Parkinson'S Disease Study (Olanzapine) Pneumonia Health (Olanzapine) PS 5 MG DAY Professional Ganaton (Itopride Other Hydrochloride) C Alfacalcidol C 24-Jun-2005 12:19 PM Page: 3518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Magnesium Oxide C Cercine (Diazepam) C Lendormin (Brotizolam) C Pursennid C Date:03/17/05ISR Number: 4611570-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0502021A Age:9 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Paxil PS Glaxosmithkline ORAL 30MG Per day Initial or Prolonged Aggression Zoloft SS ORAL 25MG Three Agitation times per day Anger Zyprexa SS Anorexia Arrhythmia Bradycardia Cognitive Disorder Depression Dystonia Eye Rolling Fear Mood Swings Myalgia Nightmare Pain In Extremity Self Mutilation Suicidal Ideation Suicide Attempt Swollen Tongue Tachycardia Date:03/17/05ISR Number: 4611610-0Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045935A Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Quilonum Retard PS Glaxosmithkline UNKNOWN Initial or Prolonged Blood Amylase Increased Remergil SS UNKNOWN 8 DAY Lipase Increased Zyprexa SS UNKNOWN 2.5MG per day 14 DAY Trevilor SS UNKNOWN 22 DAY Edronax SS UNKNOWN 4MG per day 3 DAY Tavor C UNKNOWN Ximovan C UNKNOWN 7.5MG per day 12 DAY Date:03/17/05ISR Number: 4613445-1Report Type:Direct Company Report #CTU 243501 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Zyprexa PS Required Feeling Abnormal Intervention to Weight Increased Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 3519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/05ISR Number: 4615464-8Report Type:Expedited (15-DaCompany Report #2005041391 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zoloft (Sertraline) PS ORAL 50 MG ORAL Initial or Prolonged Antipsychotic Drug Level Consumer Olanzapine Increased (Olanzapine) SS ORAL 5 MG, ORAL Delirium Memantine Disturbance In Social (Memantine) SS ORAL 5 MG, ORAL Behaviour Drug Interaction Fumbling Hallucination, Visual Restlessness Date:03/17/05ISR Number: 4619104-3Report Type:Direct Company Report #CTU 243538 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Olanzepine 2.5mg Diabetes Mellitus Bid And 20mg Po Qhs PS Diabetic Ketoacidosis Mirtazapine C Polydipsia Meclizine C Polyuria Date:03/18/05ISR Number: 4612715-0Report Type:Expedited (15-DaCompany Report #IT-ABBOTT-05P-083-0292115-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Depakine Chrono PS ORAL Depakine Chrono SS ORAL Olanzapine SS ORAL Olanzapine SS Lorazepam SS INTRAVENOUS BOLUS Lorazepam SS Potassium Chloride C ORAL Senna Leaf C ORAL Delorazepam C ORAL 14 DAY Date:03/18/05ISR Number: 4616453-XReport Type:Expedited (15-DaCompany Report #US_030493862 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acidosis Initial or Prolonged Asthma Other Atelectasis Bacterial Infection Cataract Operation Coma Cough Diabetes Mellitus Diarrhoea Dyspepsia Fasciitis Glycosylated Haemoglobin Decreased Hepatic Steatosis Hypernatraemia 24-Jun-2005 12:19 PM Page: 3520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metabolic Encephalopathy Neuropathy Pancreatitis Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Consumer Zyprexa-Oral Rhabdomyolysis Health (Olanzapine) Sputum Culture Positive Professional (Olanzapine) PS 5 MG AT Staphylococcal BEDTIME Bacteraemia Zestril (Lisinopril) C Systemic Inflammatory Zoloft (Sertraline Response Syndrome Hydrochloride) C Tachycardia Aspirin C Vaginal Discharge Desyrel (Trazodone Hydrochloride) C Vioxx (Rofecoxib) C Lopressor (Metoprolol Tartrate) C Celebrex (Celecoxib) C Combivent C Pepcid (Famotidine) C Ultram (Tramadol Hydrochloride) C Trazadone (Trazodone) C Vistaril (Hydroxyzine Embonate) C Restoril (Temazepam) C Flovent (Fluticasone Propionate) C Ventolin (Salbutamol (Sulfate) C Combivent C Singulair (Montelukast) C Date:03/18/05ISR Number: 4616522-4Report Type:Expedited (15-DaCompany Report #L04-USA-07403-04 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Literature Celexa (Citalopram Hospitalization - Anion Gap Increased Health Hydrobromide) PS Initial or Prolonged Blood Bicarbonate Professional Acetaminophen SS Decreased Clonazepam SS Blood Glucose Decreased Buspirone SS Blood Ph Decreased Olanzapine SS Coma Topiramate SS Completed Suicide Dicyclomine/Phenobar Intentional Misuse bital SS Muscle Contracture Fexofenadine SS Pco2 Decreased Gabapentin C Po2 Increased Transaminases Increased White Blood Cell Count Decreased 24-Jun-2005 12:19 PM Page: 3521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4616351-1Report Type:Expedited (15-DaCompany Report #7912 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Literature Fluphenazine PS 20 MG DAILY 1 MON Initial or Prolonged Cellulitis Health Divalproex SS 2500 MG DAILY Fluid Intake Reduced Professional Olanzapine SS 30 MG DAILY Lipase Increased Benztropine SS 2 MG DAILY Neuroleptic Malignant Syndrome Oral Intake Reduced Pneumonia Aspiration Respiratory Distress Date:03/22/05ISR Number: 4615153-XReport Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0357672A Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Deroxat PS Glaxosmithkline ORAL 13 DAY Initial or Prolonged Disturbance In Attention Xanax SS ORAL 13 DAY Hypokalaemia Laroxyl SS Glaxosmithkline ORAL Hyponatraemia Zyprexa SS ORAL 37 DAY Impaired Self-Care Aricept SS ORAL Zestoretic SS ORAL Inipomp SS ORAL Date:03/22/05ISR Number: 4618093-5Report Type:Expedited (15-DaCompany Report #US_0406103792 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus (Olanzapine) Other Diabetic Coma (Olanzapine) PS 10 MG DAY Hyperglycaemia Depakote (Valproate Hypoglycaemia Semisodium) C Ketoacidosis Wellbutrin Mental Disorder (Bupropion Vision Blurred Hydrochloride) C Celexa (Citalopram Hydrobromide) C Date:03/23/05ISR Number: 4618304-6Report Type:Expedited (15-DaCompany Report #FR_050305966 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Non-Insulin-Dependent Health (Olanzapine) Dizziness Professional (Olanzapine) PS 10 MG /1 DAY General Physical Company Seresta (Oxazepam) C Condition Abnormal Representative Tercian Hepatocellular Damage Other (Cyamemazine0 C Weight Increased Imovane (Zopiclone) C 24-Jun-2005 12:19 PM Page: 3522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618305-8Report Type:Expedited (15-DaCompany Report #FR_050305970 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cytolytic Hepatitis Foreign Zyprexa-Dispersible Initial or Prolonged Hepatic Steatosis Health (Olanzapine) Mania Professional (Olanzapine) PS 10 MG DAY Treatment Noncompliance Company Depakote (Valproate Representative Semisodium) C Other Date:03/23/05ISR Number: 4618307-1Report Type:Expedited (15-DaCompany Report #FR_050305985 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Representative Other Date:03/23/05ISR Number: 4618308-3Report Type:Expedited (15-DaCompany Report #FR_050305989 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Zyprexa-Oral Disease Recurrence Health (Olanzapine) Hypertrophic Professional (Olanzapine) PS 10 MG DAY Cardiomyopathy Company Depakote (Valproate Mania Representative Semisodium) C Psychomotor Agitation Other Clopixol (Zuclopenthixol) C Date:03/23/05ISR Number: 4618310-1Report Type:Expedited (15-DaCompany Report #EWC050343070 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Zyprexa-Oral Increased Health (Olanzapine) Metabolic Syndrome Professional (Olanzapine) PS 5 MG Weight Increased Other Fluctin-Oral (Fluoxetine )(Fluoxetine Hydrochloride SS 20 MG Date:03/23/05ISR Number: 4618311-3Report Type:Expedited (15-DaCompany Report #EWC050343072 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Zyprexa-Oral Initial or Prolonged Transaminases Increased Health (Olanzapine) Professional (Olanzapine) PS 15 MG/1 DAY Other Venlafaxine C 24-Jun-2005 12:19 PM Page: 3523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618312-5Report Type:Expedited (15-DaCompany Report #EWC050343095 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa-Oral Heart Rate Increased Health (Olanzapine) Hypotension Professional (Olanzapine) PS 10 MG /1 DAY Syncope Other Ventricular Extrasystoles Date:03/23/05ISR Number: 4618313-7Report Type:Expedited (15-DaCompany Report #DE_050315433 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 20 MG DAY Aminotransferase Other Olmesartan Medoxomil C Increased Gamma-Glutamyltransferase Increased Date:03/23/05ISR Number: 4618495-7Report Type:Expedited (15-DaCompany Report #GBS050316850 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Olanzapine Injury Asphyxiation Health (Olanzapine) PS 20 MG DAY Respiratory Arrest Professional Quetiapine C Other Diazepam C Date:03/23/05ISR Number: 4618501-XReport Type:Expedited (15-DaCompany Report #EWC050342940 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Foreign Olanzapine-Oral Drug Withdrawal Syndrome Health (Olanzapine) PS 5 MG Professional Carbolithium Company (Lithium Carbonate) C Representative Clonazepam C Date:03/23/05ISR Number: 4618503-3Report Type:Expedited (15-DaCompany Report #JP_050306036 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Moderate Mental Foreign Zyprexa-Oral Retardation Health (Olanzapine) Platelet Count Decreased Professional (Olanzapine) PS 10 MG DAY Company Benzalin Representative (Nitrazepam) C Levotomin (Levomepromazine Maleate) C 24-Jun-2005 12:19 PM Page: 3524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618561-6Report Type:Expedited (15-DaCompany Report #DE_050315434 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa Initial or Prolonged Delirium Health (Olanzapine) PS ORAL 5 MG DAY Drug Level Increased Professional Zoloft Hallucination, Visual Other (Sertraline Restlessness Hdyrchloride) C Axura (Memantine Hydrochloride) C Date:03/23/05ISR Number: 4618563-XReport Type:Expedited (15-DaCompany Report #DE_050315443 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Foreign Zyprexa Velotab Initial or Prolonged Increased Health Drug Interaction Professional (Olanzapine) PS ORAL 40 MG DAY General Physical Health Other Tavor Deterioration (Lorazepam) C Grand Mal Convulsion Trileptal Nausea (Oxcarbazepine) C Neurotoxicity Hypnorex Overdose (Lithium Somnolence Carbonate) C Speech Disorder Faustan Toxicologic Test Abnormal (Diazepam) C Visual Disturbance Nexium Vomiting (Esomeprazole Magnesium) C Beloc Zok (Metoprolol Succinate) C Date:03/23/05ISR Number: 4618565-3Report Type:Expedited (15-DaCompany Report #DE_050315448 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Foreign Zyprexa Prescribed Overdose Health (Olanzapine) PS ORAL 25 MG DAY Professional Tegretal Other (Carbamazepine Rivopharm) C Diazepam C Flunanxol Depot (Flupentixol Decanoate) C Date:03/23/05ISR Number: 4618566-5Report Type:Expedited (15-DaCompany Report #FR_050306020 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Zyprexa Health (Olanzapine) PS ORAL Professional Other 24-Jun-2005 12:19 PM Page: 3525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618568-9Report Type:Expedited (15-DaCompany Report #DE_050315432 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa Initial or Prolonged Increased Health Aspartate Professional (Olanzapine) PS ORAL 30 MG DAY Aminotransferase Other Citalopram C Increased Bifiteral Condition Aggravated (Lactulose) C Laxoberal (Sodium Picosulfate) C Date:03/23/05ISR Number: 4618569-0Report Type:Expedited (15-DaCompany Report #DE_050315369 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradyarrhythmia Foreign Zyprexa Hospitalization - Electrocardiogram Qt Health Initial or Prolonged Prolonged Professional (Olanzapine) PS ORAL 15 MG DAY Myocarditis Other Atosil Syncope (Isopromethazine Tachyarrhythmia Hydrochloride) C Ventricular Extrasystoles Lexponex (Clonzapine) C Date:03/23/05ISR Number: 4618570-7Report Type:Expedited (15-DaCompany Report #DE_050315370 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa Increased Health (Olanzapine) PS 20 MG DAY Aspartate Professional Ergenyl Aminotransferase Other (Valproate Sodium) C Increased Chromaturia Fatigue Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Jaundice Thrombocytopenia Date:03/23/05ISR Number: 4618571-9Report Type:Expedited (15-DaCompany Report #DE_050315461 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa Increased Health Aspartate Professional (Olanzapine) PS 20 MG DAY Aminotransferase Other Increased Gamma-Glutamyltransferase Increased Hepatic Steatosis Weight Increased 24-Jun-2005 12:19 PM Page: 3526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618572-0Report Type:Expedited (15-DaCompany Report #GBS050316866 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Foreign Olanzapine PS Decreased Health Valproate Sodium C White Blood Cell Count Professional Zaponex (Clozapine) C Decreased Other Date:03/23/05ISR Number: 4618643-9Report Type:Expedited (15-DaCompany Report #US_0502112220 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Consumer Evista (Raloxifene Diabetes Mellitus Health Hydrochloride) PS 60 MG/1 DAY Inadequate Control Professional Zyprexa-Oral, Dyspnoea (Olanzapine) ) Fatigue (Olanzapine) SS 10 MG/1 DAY Headache Symbyax-Olanzapine / Osteopenia Fluoxetine (Ola SS Syncope Seroquel (Quetiapine Wheezing Fumarate) C Lithiium C Zoloft (Sertraline Hydrochloride) C Calcium Citrate With Vitamin D C Acetaminophen And Codeine No. 3 C Phenergan (Promethazine Hydrochloride) C Albuterol C Ibuprofen (Ibuprofen) C Starlix (Nateglinide) C Singulair (Montelukast) C Lamictal (Lamotrigine) C Celebrex (Celecoxib) C Fluticasone C Salmeterol C Trihexyphenidyl C Date:03/23/05ISR Number: 4618816-5Report Type:Expedited (15-DaCompany Report #US_0503114056 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618817-7Report Type:Expedited (15-DaCompany Report #US_0503114169 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Consumer Zyprexa-Oral Renal Failure (Olanzapine) (Olanzapine) PS Date:03/23/05ISR Number: 4618818-9Report Type:Expedited (15-DaCompany Report #US_0502112990 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/23/05ISR Number: 4618819-0Report Type:Expedited (15-DaCompany Report #US_0502113138 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Pancreatitis (Olanzapine) (Olanzapine) PS Date:03/23/05ISR Number: 4618820-7Report Type:Expedited (15-DaCompany Report #US_0502113169 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/23/05ISR Number: 4618821-9Report Type:Expedited (15-DaCompany Report #US_0408105064 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Other Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Mb Increased Blood Lactate Dehydrogenase Increased Contusion Diabetes Mellitus Diabetic Ketoacidosis Diarrhoea Dizziness Headache Hypokalaemia Hypomania Mania Pneumonia Refusal Of Treatment By Patient 24-Jun-2005 12:19 PM Page: 3528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Road Traffic Accident Thermal Burn Ulcer Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG Humalog-. (Lispro) SS Humulin-Human Nph Insulin (Rdna) (Human Insulin (Rd SS Clonazpema C Eskalith Cr (Lithium Carbonate) C Cogentin (Benzatropine Mesilate) C Altace (Ramipril Dura) C Benadryl C Potassium Chloride C Date:03/23/05ISR Number: 4618822-0Report Type:Expedited (15-DaCompany Report #USA050392347 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/23/05ISR Number: 4618823-2Report Type:Expedited (15-DaCompany Report #USA050392340 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/23/05ISR Number: 4618843-8Report Type:Expedited (15-DaCompany Report #USA031050668 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Health Zyprexa-Oral Pregnancy Professional (Olanzapine) Metrorrhagia (Olanzapine) PS 10 MG/ 2 IN THE MORNING Haldol (Haloperidol) C Date:03/23/05ISR Number: 4618844-XReport Type:Expedited (15-DaCompany Report #US_0502112134 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Prolapse Consumer Zyprexa-Oral Initial or Prolonged Cor Pulmonale Health (Olanzapine) Other Diabetes Mellitus Professional (Olanzapine) PS Haematemesis Spigelian Hernia 24-Jun-2005 12:19 PM Page: 3529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618845-1Report Type:Expedited (15-DaCompany Report #US_0409105409 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Consumer Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) Blood Cholesterol Professional (Olanzapine) PS 10 MG DAY Increased Olanzipine/Fluoxetin Blood Triglycerides e C Increased Celexa (Citalopram Cellulitis Hydrobromide) C Depression Anafranil(Clomiprami Diabetes Mellitus ne Hydrochloride) C Non-Insulin-Dependent Lotrel C Dyspnoea Prednisolone C Erectile Dysfunction Prednisone Gastrooesophageal Reflux (Prednisone) C Disease Hycrochlorothiazide C Headache Viagra(Sildenafil Hyperhidrosis Citrate) C Joint Sprain Darvocet-N C Myocardial Infarction Aspirin(Acetylsalicy Oedema Peripheral lic Acid) C Qrs Axis Abnormal Zyrtec(Cetirizine Sinus Disorder Hydrochloride) C Sleep Disorder Nasonex(Mometasone Weight Increased Furoate) C Allegra(Fexofenadine Hydrochloride) C Desloratadine C Rabeprazole C Nitroglycerin(Glycer yl Trinitrate) C Tricor (Fenofibrate) C Zithromax Z-Pack(Azithromycin) C Augmentin C Amoxicillin C Clobetasol C Meperidine C Claritin (Loratadine) C Actos(Pioglitazone Hydrochloride) C Naproxen Sodium C Date:03/23/05ISR Number: 4618846-3Report Type:Expedited (15-DaCompany Report #US_0410106336 Age:34 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anorectal Disorder Initial or Prolonged Blood Chloride Increased Other Blood Sodium Decreased Breath Odour Bronchitis Chronic Obstructive Pulmonary Disease Cough Diabetes Mellitus Diabetes Mellitus Insulin-Dependent 24-Jun-2005 12:19 PM Page: 3530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Ketoacidosis Diabetic Neuropathy Dry Mouth Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa-Oral Haematuria Health (Olanzapine) Hepatitis Viral Professional (Olanzapine) PS 15 MG AT Hyperaemia BEDTIME Hypercholesterolaemia Humalog-. (Lispro) SS Hypertension Topamax (Topiramate) C Hypoglycaemia Quetiapine C Hypokalaemia Risperidone C Ketoacidosis Depakote (Valproate Lethargy Semisodium) C Nocturia Lipitor Oedema Peripheral (Atorvastatin Onychomycosis Calcium) C Pancreatitis Prilosec Rectal Haemorrhage (Omeprazole) C Thirst Treatment Noncompliance Urine Output Increased Vision Blurred Weight Decreased Wheezing Date:03/23/05ISR Number: 4618847-5Report Type:Expedited (15-DaCompany Report #US_0411107895 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Life-Threatening Diabetic Ketoacidosis (Olanzapine) Other Injury (Olanzapine) PS UNKNOWN UNK Seroquel (Quetiapine Fumarate) C Haldol (Haloperidol Decanoate) C Depakote (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Fluoxetine (Fluoxetine) C Prednisolone C Clonazepam C Benztropine C Fluocinolone Acetonide C Zyrtec (Cetirizine Hydrochloride) C Risperdal (Risperidone) C Diphenhydramine C Sulfamethoxazole C Prometrium (Progesterone) C 24-Jun-2005 12:19 PM Page: 3531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4618865-7Report Type:Expedited (15-DaCompany Report #USA040979381 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Maculopathy Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 20 MG/1 DAY Paxil (Paroxetine Hydrochloride) C Date:03/24/05ISR Number: 4618276-4Report Type:Expedited (15-DaCompany Report #FR_041205456 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Foreign Zyprexa-Oral Electroencephalogram Health (Olanzapine) Abnormal Professional (Olanzapine) PS 10 MG DAY Company Representative Other Date:03/24/05ISR Number: 4618284-3Report Type:Expedited (15-DaCompany Report #FR_050205765 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Varices Foreign Zyprexa-Oral Haemorrhage Health (Olanzapine) Gastrointestinal Professional (Olanzapine) PS 20 MG/1 DAY 0 YR Haemorrhage Company Lysanxia (Prazepam) C Oesophageal Varices Representative Imovane (Zopiclone) C Haemorrhage Other Date:03/24/05ISR Number: 4618286-7Report Type:Expedited (15-DaCompany Report #EWC050342999 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colitis Ischaemic Foreign Zyprexa-Oral Hospitalization - Hypothyroidism Health (Olanzapine) Initial or Prolonged Psychotic Disorder Professional (Olanzapine) PS 30 MG DAY Other Pulmonary Haemorrhage Company Topiramate C Renal Failure Representative Heparin C Shock Other Aripiprazole C Vomiting X-Ray Gastrointestinal Tract Abnormal Date:03/24/05ISR Number: 4618291-0Report Type:Expedited (15-DaCompany Report #CA_040907271 Age:57 YR Gender:Male I/FU:F Outcome PT Death Abdominal Discomfort Blood Cholesterol Increased Blood Sodium Decreased Coronary Artery Atherosclerosis Coronary Artery Stenosis Fungal Rash 24-Jun-2005 12:19 PM Page: 3532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Lobar Pneumonia Low Density Lipoprotein Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Olanzapine-Oral Movement Disorder Study (Olanzapine) PS 15 MG IN THE Pulmonary Congestion Health EVENING Pulmonary Oedema Professional Epival (Valproate Thyroid Neoplasm Other Semisodium) SS 1500 MG IN THE EVENING Clonazepam C Zopiclone C Losec (Omeprazole Magnesium) C Vioxx (Rofecoxib) C Date:03/24/05ISR Number: 4618297-1Report Type:Expedited (15-DaCompany Report #JP_050105573 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Zyprexa-Oral Hospitalization - Aggression Study (Olanzapine) Initial or Prolonged Choking Health Olanzapine PS 5 MG/1 DAY Fall Professional Risperdal Pleurisy Other (Risperidone) C Restlessness Akineton (Biperiden Lactate) C Depakene (Valproate Sodium) C Doral (Quazepam) C Desyrel (Trazodone Hydrochloride) C Biasan C Pentona (Mazaticol Hydrochloride) C Hangekoubokutou C Date:03/24/05ISR Number: 4618303-4Report Type:Expedited (15-DaCompany Report #EWC050142155 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Olanzapine-Rapid-Act Life-Threatening Cardiac Arrest Health ing Im PS 10 MG Gastrointestinal Professional Rivotril Haemorrhage Other (Clonazepam) C Shock Sudden Death Date:03/24/05ISR Number: 4618333-2Report Type:Expedited (15-DaCompany Report #GBS050316845 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Infarction Foreign Olanzapine-Oral Condition Aggravated Health (Olanzapine) PS Neurosis Professional Panic Disorder With Other Agoraphobia Road Traffic Accident 24-Jun-2005 12:19 PM Page: 3533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/05ISR Number: 4618339-3Report Type:Expedited (15-DaCompany Report #FR_050306000 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Zyprexa-Oral Initial or Prolonged Cerebral Ischaemia Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Other Deroxat (Paroxetine Hydrochloride) C Atarax (Alprazolam) C Kardegic (Acetylsalicylate Lysine) C Date:03/24/05ISR Number: 4618342-3Report Type:Expedited (15-DaCompany Report #CA_050307832 Age:1 DY Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cleft Lip Foreign Olanzapine-Oral Congenital Anomaly Literature (Olanzapine) PS Drug Exposure During Health Pregnancy Professional Encephalocele Other Multiple Congenital Abnormalities Neural Tube Defect Date:03/24/05ISR Number: 4618346-0Report Type:Expedited (15-DaCompany Report #JP_050306088 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatic Function Abnormal Foreign Zyprexa-Oral Serotonin Syndrome Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Company Zotepine C Representative Biperiden Other Hydrochloride C Flunitrazepam C Date:03/24/05ISR Number: 4618351-4Report Type:Expedited (15-DaCompany Report #GBS050316835 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bruxism Foreign Olanzapine-Oral Other Condition Aggravated Health (Olanzapine) PS 50 MG Insomnia Professional Depakote (Valproate Medical Device Other Semisodium) C Complication Novonorm Muscle Spasms (Repaglinide) C Pain Zolpidem C Prescribed Overdose Ramipril C Date:03/24/05ISR Number: 4618610-5Report Type:Expedited (15-DaCompany Report #US_0411108209 Age:44 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 3534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Cholecystectomy Consumer Zyprexa-Oral Diabetes Mellitus (Olanzapine) Pancreatitis (Olanzapine) PS 10 MG/L DAY Weight Increased Serzone (Nefazodone Hydrochloride) C Risperdal (Risperidone) C Geodon (Ziprasidone Hydrochloride) C Depakote (Valproate Semisodium) C Hydrochlorothiazide C Date:03/24/05ISR Number: 4618613-0Report Type:Expedited (15-DaCompany Report #US_0502111957 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystocele Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Rectocele Professional (Olanzapine) PS 20 MG Urinary Incontinence Symbyax C Alprazolam C Wellbutrin (Bupropion Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Trazodone (Trazodone) C Amaryl (Glimepiride) C Tenormin (Atenolol Eg) C Valium (Diazepam) C Prevacid (Lansoprazole) C Propulsid (Cisapiride) C Centrum C Ambien (Zolpidem Tartrate) C Premarin C Zithromax (Azithromycin) C Date:03/24/05ISR Number: 4618616-6Report Type:Expedited (15-DaCompany Report #USA050290334 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematemesis Health Zyprexa - Oral Vomiting Professional (Olanzapine) Company (Olanzapine) PS 20 MG Representative Zyprexa-Dispersible (Olanzapine) (Olanzapine) SS 20 MG 24-Jun-2005 12:19 PM Page: 3535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/05ISR Number: 4618680-4Report Type:Expedited (15-DaCompany Report #USA050392318 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa Initial or Prolonged Prescribed Overdose Zydis-Dispersible Weight Increased (Olanzapine) (Olanzapine) PS 40 MG Glycine C Niacin C Zoloft (Sertraline Hydrochloride) C Date:03/24/05ISR Number: 4618709-3Report Type:Expedited (15-DaCompany Report #USA040875114 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) Other Increased Appetite Professional (Olanzapine) PS 20 M DAY Treatment Noncompliance Lipitor Weight Increased (Atorvastatin) C Paxil (Paroxetine Hydrochloride) C Haldol (Haloperidol Decanoate) C Lorazepam C Date:03/24/05ISR Number: 4619678-2Report Type:Expedited (15-DaCompany Report #CA_050307838 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Foreign Zyprexa PS 5 MON Initial or Prolonged Incontinence Consumer Risperidone C Panic Attack Other Clopixol (Zuclopenthixol) C Date:03/24/05ISR Number: 4620111-5Report Type:Expedited (15-DaCompany Report #2004100041 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Xanax Initial or Prolonged Disturbance In Attention Health (Alprazolam) PS ORAL ORAL Hyponatraemia Professional Donepezil Other Hydrochloride (Donepezil Hydrochloride) SS ORAL ORAL Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL ORAL Paroxetine Hydrochloride SS ORAL ORAL Olanzapine SS ORAL ORAL Prinzide (Hydrochlorothiazide , Lisinopril) C 24-Jun-2005 12:19 PM Page: 3536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantoprazole C Date:03/24/05ISR Number: 4621333-XReport Type:Direct Company Report #CTU 244187 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Zyprexa 10 Mg PS ORAL 10MG DAILY ORAL Date:03/28/05ISR Number: 4619943-9Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0294168-00 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Ergenyl Tablets PS ORAL Hepatitis Ergenyl Tablets SS Jaundice Methadone Thrombocytopenia Hydrochloride C ORAL Olanzapine I ORAL Olanzapine I ORAL Olanzapine I ORAL Date:03/28/05ISR Number: 4621560-1Report Type:Expedited (15-DaCompany Report #7911 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Iron Decreased Literature Fluphenazine PS INJ Initial or Prolonged Blood Pressure Health Olanzapine SS 10 MG 1 MON Fluctuation Professional Chills Coma Confusional State Disorientation Grand Mal Convulsion Hypokalaemia Neuroleptic Malignant Syndrome Pneumonia Renal Failure Acute Respiratory Acidosis Rhabdomyolysis Somnolence Tachycardia Tremor Urinary Tract Infection Date:03/28/05ISR Number: 4621664-3Report Type:Expedited (15-DaCompany Report #2004071266 Age:34 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Geodon (Ziprasidone) PS Other Completed Suicide Consumer Olanzapine Multiple Drug Overdose (Olanzapine) SS Clonazepam (Clonazepam) SS 24-Jun-2005 12:19 PM Page: 3537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/05ISR Number: 4623102-3Report Type:Direct Company Report #CTU 244451 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Olanzapine PS ORAL 5MG QHS + Initial or Prolonged Corrected Interval Q6H PRN ORAL Prolonged Quetiapine SS ORAL 25MG/50MG Electrocardiogram T Wave QAM/QHS ORAL Inversion Date:03/28/05ISR Number: 4623126-6Report Type:Direct Company Report #CTU 244465 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Olanzapine 2.5 Eli Hospitalization - Blood Creatine Lilly PS Eli Lilly ORAL 15 MG OVER 4 Initial or Prolonged Phosphokinase Increased HOURS ORAL Blood Pressure Abnormal Haloperidol 5 Mg/Ml Dehydration Amp Ortho-Mcneil SS Orth-Mcneil INTRAMUSCULAR 2 MG ONE TIME Feeling Abnormal INTRAMUSCULAR Fluid Intake Reduced Pramipexole C Hyperhidrosis Selegiline C Hyperpyrexia Carbidopa/Levodopa C Lethargy Glyburide C Leukocytosis Lisinopril C Mental Status Changes Diltiazem C Muscle Rigidity Digoxin C Oral Intake Reduced Gabapentin C Pain Renal Failure Acute Tachycardia Tachypnoea Urinary Incontinence Date:03/29/05ISR Number: 4622694-8Report Type:Direct Company Report #CTU 244599 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Zyprexa PS Thromboplastin Time Argatroban SS Shortened Date:03/29/05ISR Number: 4623243-0Report Type:Expedited (15-DaCompany Report #US_0501110653 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ketoacidosis Consumer Zyprexa-Oral Other Pancreatitis (Olanzapine) (Olanzapine) PS Date:03/29/05ISR Number: 4623321-6Report Type:Expedited (15-DaCompany Report #US_030695122 Age:25 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Agitation Other Blood Glucose Increased Coma 24-Jun-2005 12:19 PM Page: 3538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Delusion Diabetes Mellitus Report Source Product Role Manufacturer Route Dose Duration Encephalopathy Consumer Zyprexa-Oral Eye Pain Health (Olanzapine) Glycosuria Professional (Olanzapine) PS 10 MG/2 AT Hyperkalaemia BEDTIME Hyperlipidaemia Humulin-Human Hypernatraemia Regular Insulin Hypertension (Rdna) (Human Hypovolaemia Insulin SS Insomnia Haldol (Haloperidol) C Leukocytosis Depakote (Valproate Mental Status Changes Semisodium) C Motor Dysfunction Seroquel (Quetiapine Paranoia Fumarate) C Polyuria Lorazepam C Protein Total Increased Benztropine C Renal Failure Acute Nicotine Dermal Restlessness Patch (Nicotine Rhabdomyolysis Resin) C Sinus Tachycardia Temazepam C Social Avoidant Behaviour Geodon (Ziprasidone Treatment Noncompliance Hydrochloride) C Vomiting Lithium C Weight Increased Date:03/29/05ISR Number: 4623676-2Report Type:Expedited (15-DaCompany Report #FR_050305998 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Foreign Zyprexa-Oral Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Representative Other Date:03/29/05ISR Number: 4624037-2Report Type:Expedited (15-DaCompany Report #EWC041242041 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Olanzapine-Oral Convulsion Health (Olanzapine) PS 10 MG/1 DAY Injury Professional Trihexyphenidyl C Date:03/30/05ISR Number: 4623224-7Report Type:Expedited (15-DaCompany Report #US_0411108209 Age:40 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Accidental Exposure Other Anaemia Anorexia Asthenia Bronchitis Bulimia Nervosa Cholelithiasis 24-Jun-2005 12:19 PM Page: 3539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Compulsions Constipation Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa-Oral Non-Insulin-Dependent Health (Olanzapine) Disorientation Professional (Olanzapine) PS 10 MG/1 DAY Drug Dependence Serzone (Nefazodone Drug Withdrawal Syndrome Hydrochloride) C Ear Pain Risperdal Eating Disorder (Risperidone) C Electrocardiogram Depakote (Valproate Abnormal Semisodium) C Fatigue Hydrochlorothiazide C Fibromyalgia Levothyroxine C Gastritis Estradiol C Gastrooesophageal Reflux Hydrocodone W/Apap C Disease Cozaar (Losartan Hepatic Enzyme Increased Potassium) C Hepatic Mass Lipitor Herpes Simplex (Atorvastatin Hypercholesterolaemia Calcium) C Hyperlipidaemia Neurontin Hypertension (Gabapentin Pfizer) C Hypoglycaemia Amitriptyline C Insomnia Metoclopramide C Irritable Bowel Syndrome Clonidine C Joint Sprain Imitrex (Sumatriptan Mania Succinate) C Meningioma Topamax (Topiramate) C Mental Status Changes Norvasc (Amlodipine) C Nephrolithiasis Ibuprofen Obesity (Ibuprofen) C Pancreatitis Nicotrol (Nicotine) C Pancreatitis Chronic Vioxx (Rofecoxib) C Rhinitis Skelaxin Sinusitis (Metaxalone) C Skin Papilloma Ultram (Tramadol Sleep Apnoea Syndrome Hydrochloride) C Upper Respiratory Tract Zanaflex (Tizanidine Infection Hydrochloride) C Vision Blurred Ambien (Zolpidem Weight Decreased Tartrate) C Weight Increased Date:03/30/05ISR Number: 4623230-2Report Type:Expedited (15-DaCompany Report #US_0503114440 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4623232-6Report Type:Expedited (15-DaCompany Report #USA050392634 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Health Professional Company 24-Jun-2005 12:19 PM Page: 3540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS Benzodiazepine C Date:03/30/05ISR Number: 4623236-3Report Type:Expedited (15-DaCompany Report #USA050392640 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS Representative Benzodiazepine C Date:03/30/05ISR Number: 4623253-3Report Type:Expedited (15-DaCompany Report #US_0411107958 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Consumer Zyprexa-Oral Initial or Prolonged Agitation Health (Olanzapine) Other Asthma Professional (Olanzapine) PS 30 MG/1 DAY Blood Triglycerides Humulin-Human Nph Increased Insulin (Rdna) Cellulitis (Human Insulin (Rd SS Chills Humulin-Human Decreased Appetite Regular Insulin Depression (Rdna)(Human Insulin SS Diabetes Mellitus Abilify Inadequate Control (Aripiprazole) C Diabetes Mellitus Quetiapine C Non-Insulin-Dependent Risperdal Electrocardiogram (Risperidone) C Abnormal Haldol (Haloperidol Fatigue Decanoate) C Gastrooesophageal Reflux Depakote (Valproate Disease Semisodium) C Glucose Urine Present Lithium C Hepatic Steatosis Bupropion C Hyperphagia Novolin Nph (Insulin Hypothyroidism Human Injection, Irritability Isophane) C Lethargy Novolin R (Insulin Migraine Human) C Myocardial Infarction Glyburide Nausea W/Metformin C Oedema Peripheral Neurontin Prescribed Overdose (Gabapentin Pfizer) C Respiratory Fremitus Desyrel (Trazodone Social Avoidant Behaviour Hydrochloride) C Syncope Temazepam C Urinary Tract Infection Lorazepam C Ventricular Hypertrophy Acetaminophen C Vomiting Femhrt C Weight Decreased Claritin Weight Increased (Loratadine) C Lipitor 24-Jun-2005 12:19 PM Page: 3541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin Calcium) C Accupril (Quinapril Hydrochloride) C Glucophage (Metformin) C Nicotrol (Nicotine) C Allegra (Fexofenadine Hydrochloride) C Risperdal (Risperidone) C Avapro (Irbesartan) C Avandamet C Atacand (Candesartan Cilexetil) C Pantoprazole C Bactrim C Potassium Chloride C Diflucan (Fluconazole) C Glyburide C Lisinopril (Lisinopril) C Furosemide (Furosemide) C Nafcillin C Zocor (Simvastatin Ratiopharm) C Promethazine C Ampicillin C Gentamycin C Vistaril (Hydroxyzine Embonate) C Dulcolax (Bisacodyl) C Synthroid (Levothyroxine Sodium) C Date:03/30/05ISR Number: 4625658-3Report Type:Expedited (15-DaCompany Report #DE_030711712 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Zyprexa-Oral Initial or Prolonged Cognitive Disorder Health (Olanzapine) Other Drug Toxicity Professional (Olanzapine) PS 10 MG DAY Grand Mal Convulsion Company Hyponatraemia Representative Infection Other Intentional Misuse Mutism Pupillary Reflex Impaired Rhabdomyolysis Stupor Vomiting White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 3542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/05ISR Number: 4625659-5Report Type:Expedited (15-DaCompany Report #DE_050315461 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Foreign Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Other Date:03/30/05ISR Number: 4625660-1Report Type:Expedited (15-DaCompany Report #JP_041205477 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa-Oral Delusion Study (Olanzapine) Hostility Health (Olanzapine) PS 10 MG DAY Irritability Professional Benzalin Restlessness Other (Nitrazepam) C Screaming Maglax (Magenesium Self-Injurious Ideation Oxide) C Soliloquy Senna Liquid Extract C Ensure Liquid C Date:03/30/05ISR Number: 4625735-7Report Type:Expedited (15-DaCompany Report #JP_041205539 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa-Oral Electrocardiogram Qt Study (Olanzapine) Corrected Interval Health (Olanzapine) PS 5 MG/1 DAY Prolonged Professional Tasmolin (Biperiden) C Long Qt Syndrome Ventricular Extrasystoles Date:03/30/05ISR Number: 4625736-9Report Type:Expedited (15-DaCompany Report #JP_050205863 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epilepsy Foreign Zyprexa-Oral Fall Health (Olanzapine) Gaze Palsy Professional (Olanzapine) PS 20 MG DAY Company Levotomin Representative (Levomepromazine Maleate) C Artane (Trihexyphenidyl Hydrochloride) C Depas (Etizolam) C Lendormin (Brotizolam) C Lodopin (Zotepine) C Date:03/30/05ISR Number: 4625738-2Report Type:Expedited (15-DaCompany Report #EWC050242684 Age:38 YR Gender:Male I/FU:F Outcome PT Death Cardiac Arrest Conduction Disorder 24-Jun-2005 12:19 PM Page: 3543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extrasystoles Loss Of Consciousness Prescribed Overdose Report Source Product Role Manufacturer Route Dose Duration Sudden Death Foreign Zyprexa-Dispersible Health (Olanzapine) Professional (Olanzapine) PS 10 MG/2 DAY Company Depakin Chrono Representative (Valproate Sodium) C Other Tavor (Lorazepam) C Kcl-Retard (Potassium Chloride) C Pursennid C En (Delorazepam) C Date:03/30/05ISR Number: 4625744-8Report Type:Expedited (15-DaCompany Report #GBS050316885 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Olanzapine-Oral Hospitalization - Asphyxia Health (Olanzapine) PS 20 MG Initial or Prolonged Cyanosis Professional Zopiclone C Other Feeling Abnormal Company Snoring Representative Weight Increased Date:03/30/05ISR Number: 4625747-3Report Type:Expedited (15-DaCompany Report #GBS050316939 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Olanzapine-Oral Initial or Prolonged Inappropriate Health (Olanzapine) PS 2.5 MG Antidiuretic Hormone Professional Mirtazapine C Secretion Other Prednisolone C Psychotic Disorder Timolol C Date:03/30/05ISR Number: 4625749-7Report Type:Expedited (15-DaCompany Report #GBS050316931 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Foreign Olanzapine-Oral Initial or Prolonged Deep Vein Thrombosis Health (Olanzapine) PS 5 MG Professional Warfarin C Other Date:03/30/05ISR Number: 4625764-3Report Type:Expedited (15-DaCompany Report #DE_050315454 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Foreign Zyprexa-Oral Aminotransferase Health (Olanzapine) Increased Professional (Olanzapine) PS 20 MG DAY Blood Alkaline Other Lorazepam C Phosphatase Increased Quilonum - Slow Release (Lithium Carbonage) C 24-Jun-2005 12:19 PM Page: 3544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/05ISR Number: 4625765-5Report Type:Expedited (15-DaCompany Report #DE_050315472 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa-Oral Initial or Prolonged Bone Marrow Depression Health (Olanzapine) Prescribed Overdose Professional (Olanzapine) PS 30 MG DAY Other Tegretal (Carbamazepine Rivopharm) C Dipiperon (Pipamperone Hydrochloride) C Enahexal (Enalapril Maleate) C Ass 100 "Ct-Arzneimittel" (Acetylsalicylic Acid) C Date:03/30/05ISR Number: 4625767-9Report Type:Expedited (15-DaCompany Report #EWC050343214 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Zyperxa-Oral Shock Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Company Zinacef (Cefuroxime Representative Sodium) C Other Seroquel (Quetiapine Fumarate) C Date:03/30/05ISR Number: 4625768-0Report Type:Expedited (15-DaCompany Report #EWC050343179 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Zyprexa-Oral Increased Health (Olanzapine) Blood Glucose Increased Professional (Olanzapine) PS 40 MG Metabolic Syndrome Other Akineton Retard (Biperiden Hydrochloride) C Praxiten (Oxaxepam) C Date:03/30/05ISR Number: 4625770-9Report Type:Expedited (15-DaCompany Report #FR_050306005 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zyprexa-Oral Other Pulmonary Oedema Company (Olanzapine) Weight Increased Representative (Olanzapine) PS 10 MG DAY Other 24-Jun-2005 12:19 PM Page: 3545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/05ISR Number: 4625772-2Report Type:Expedited (15-DaCompany Report #EWC050343253 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebellar Ataxia Foreign Zyprexa Velotab-Oral Hospitalization - Sudden Death Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 10 MG/1 DAY Company Benzodiazepine C Representative Tranxene Other (Clorazepate Dipotassium) C Date:03/30/05ISR Number: 4625773-4Report Type:Expedited (15-DaCompany Report #FR_050306034 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Disorder Foreign Zyprexa-Oral Depressed Mood Health (Olanzapine) Dyspnoea Professional (Olanzapine) PS 10 MG/1 DAY Dysuria Other Valium (Diazepam) C Deroxate (Paroxetine Hydrochloride) C Date:03/30/05ISR Number: 4625775-8Report Type:Expedited (15-DaCompany Report #JP_050306095 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Zyprexa-Oral Initial or Prolonged Loss Of Consciousness Health (Olanzapine) Multiple Drug Overdose Professional (Olanzapine) PS 100 MG Suicide Attempt Company Levotomin Representative (Levomepromazine Other Maleate) C Date:03/30/05ISR Number: 4625872-7Report Type:Expedited (15-DaCompany Report #US_0502113095 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4625874-0Report Type:Expedited (15-DaCompany Report #US_0502113208 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4625888-0Report Type:Expedited (15-DaCompany Report #EWC050142155 Age:35 YR Gender:Female I/FU:F Outcome PT Death Apnoea Life-Threatening Cardiac Arrest Gastrointestinal 24-Jun-2005 12:19 PM Page: 3546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Shock Sudden Death Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Rapid-Act Health ing Im PS 10 MG Professional Rivotril Other (Clonazepam) C Date:03/30/05ISR Number: 4625889-2Report Type:Expedited (15-DaCompany Report #US_0502112390 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Zyprexa-Rapid Acting Hospitalization - Drug Toxicity Health Im (Olanzapine) PS Initial or Prolonged Hypotension Professional Midazolam C Multi-Organ Failure Company Diazepam C Representative Other Date:03/30/05ISR Number: 4625926-5Report Type:Expedited (15-DaCompany Report #US_0402100535 Age:56 YR Gender:Female I/FU:F Outcome PT Other Abdominal Distension Activities Of Daily Living Impaired Angina Unstable Blood Pressure Increased Breast Cancer Female Breast Cancer Metastatic Breast Cancer Stage Ii Breast Microcalcification Breast Pain Chest Pain Depression Difficulty In Walking Dizziness Drug Ineffective Dyspnoea Electrocardiogram T Wave Inversion Emotional Distress Erythema Fatigue Food Craving Headache Hot Flush Hypertension Increased Appetite Insomnia Ischaemia Mastitis Mechanical Complication Of Implant Myocardial Infarction Oestrogen Receptor Assay Positive Pain Pollakiuria 24-Jun-2005 12:19 PM Page: 3547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Post Procedural Complication Progesterone Receptor Report Source Product Role Manufacturer Route Dose Duration Assay Positive Consumer Zyprexa-Oral Renal Pain (Olanzapine) Rhinitis (Olanzapine) PS Sensation Of Pressure Prozac-Oral Stress (Fluoxetine) Thirst (Fluoxetine Tinnitus Hydrochloride) SS Upper Respiratory Tract Lexapro Infection (Escitalopram) C Weight Increased Topamax (Topiramate) C Lorazepam C Depakote (Valproate Semisodium) C Premarin C Date:03/30/05ISR Number: 4625929-0Report Type:Expedited (15-DaCompany Report #USA050393108 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Consumer Zyprexa-Oral Blood Pressure Decreased (Olanzapine) Pyrexia (Olanzapine) PS 10 MG Supraventricular Topamax (Topiramate) C Tachycardia Paxil (Paroxetine White Blood Cell Count Hydrochloride) C Increased Date:03/30/05ISR Number: 4625950-2Report Type:Expedited (15-DaCompany Report #US_0503113571 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Pancreatitis (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4625996-4Report Type:Expedited (15-DaCompany Report #US_0503114238 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Study Olanzapine-Long-Acti Initial or Prolonged Consciousness Health ng Im (Depot) PS OTHER 300 MG EVERY Other Oxygen Saturation Professional OTHER WEEK Decreased Advair C Respiratory Acidosis Diazepam C Skin Discolouration Date:03/30/05ISR Number: 4626151-4Report Type:Expedited (15-DaCompany Report #US_0503114459 Age:49 YR Gender:Female I/FU:F Outcome PT Other Anaemia Blood Alkaline Phosphatase Increased Blood Cholesterol 24-Jun-2005 12:19 PM Page: 3548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Triglycerides Increased Cataract Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa-Oral Non-Insulin-Dependent (Olanzapine) Fatigue (Olanzapine) PS 2.5 MG AT Hyperphagia BEDTIME Microalbuminuria Lipitor Middle Insomnia (Atorvastatin Pollakiuria Calcium) C Pyrexia Atenolol C Retinopathy Hypertensive Easprin Therapeutic Response (Acetylsalicylic Unexpected Acid) C Thirst Chlorpromazine C Urinary Tract Infection Accupril (Quinapril Vomiting Hydrochloride) C Weight Decreased Norvasc (Amlodipine) C White Blood Cell Count Increased Date:03/30/05ISR Number: 4626153-8Report Type:Expedited (15-DaCompany Report #US_0502112990 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626196-4Report Type:Expedited (15-DaCompany Report #2004120941 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Foreign Xanax Tablet Initial or Prolonged Imbalance Health (Alprazolam) PS ORAL ORAL Catatonia Professional Amitriptyline Depressed Level Of Hydrochloride Consciousness (Amitriptyline Hyponatraemia Hydrochloride) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Paroxetine Hydrochloride (Paroxetine Hydrochloride) SS ORAL 200 MG, ORAL Donepezil Hydrochloride (Donepezil Hydrochloride) SS ORAL Prinzide (Hydrochlorothiazide , Lisinopril) C Pantoprazole (Pantoprazole) C 24-Jun-2005 12:19 PM Page: 3549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/05ISR Number: 4626397-5Report Type:Expedited (15-DaCompany Report #US_0503114459 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Zyprexa-Oral Blood Alkaline (Olanzapine) Phosphatase Increased (Olanzapine) PS 2.5 MG AT Blood Cholesterol BEDTIME Increased Lipitor Blood Glucose Increased (Atorvastatin Blood Triglycerides Calcium) C Increased Atenolol C Cataract Easpirin Glucose Urine (Acetylsalicylic Hyperphagia Acid) C Insomnia Chlorpromazine C Microalbuminuria Accupril (Quinapril Pollakiuria Hydrochloride) C Retinopathy Hypertensive Norvasc (Amlodipine) C Thirst Urinary Tract Infection Vomiting Weight Decreased White Blood Cell Count Increased Date:03/30/05ISR Number: 4626398-7Report Type:Expedited (15-DaCompany Report #US_0502113066 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626431-2Report Type:Expedited (15-DaCompany Report # US_0502113138 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Zyprexa-Oral Pancreatitis (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626438-5Report Type:Expedited (15-DaCompany Report #US_0502113169 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626439-7Report Type:Expedited (15-DaCompany Report #USA041183051 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Death Circulatory Collapse Consumer Other Myocardial Infarction Health Obesity Professional Company 24-Jun-2005 12:19 PM Page: 3550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa-Oral (Olanzapine) (Olanzapine) PS 7.5 MG/1 AT BEDTIME Date:03/30/05ISR Number: 4626479-8Report Type:Expedited (15-DaCompany Report #US_0502113431 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626480-4Report Type:Expedited (15-DaCompany Report #US_0502113485 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626530-5Report Type:Expedited (15-DaCompany Report #USA050393219 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharmaceutical Product Health Zyprexa-Oral Initial or Prolonged Complaint Professional (Olanzapine) Schizophrenia, Paranoid (Olanzapine) PS 30 MG DAY Type Zyprexa-Dispersible Vomiting (Olanzapine) (Olanzapine) SS 30 MG DAY Date:03/30/05ISR Number: 4626531-7Report Type:Expedited (15-DaCompany Report #US_0411107547 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Consumer Zyprexa-Oral Abnormal (Olanzapine) Diabetes Mellitus (Olanzapine) PS Hyperinsulinism Hypertension Obesity Polytraumatism Renal Disorder Vision Blurred Date:03/30/05ISR Number: 4626532-9Report Type:Expedited (15-DaCompany Report #US_0406103928 Age:55 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Alanine Aminotransferase Other Increased 24-Jun-2005 12:19 PM Page: 3551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albumin Globulin Ratio Decreased Anion Gap Increased Report Source Product Role Manufacturer Route Dose Duration Beta Haemolytic Consumer Zyprexa-Oral Streptococcal Infection (Olanzapine) Blood Chloride Decreased (Olanzapine) PS 20 MG AT Blood Sodium Decreased BEDTIME 4 YR Blood Triglycerides Humulin-Human Nph Increased Insulin (Rdna) Diabetes Mellitus (Human Insulin (Rd SS Diabetic Ketoacidosis Lithium C Fungus Urine Test Symmetrel Positive (Amantadine High Density Lipoprotein Hydrochloride) C Decreased Ativan (Lorazepam) C Mean Cell Haemoglobin Vioxx (Rofecoxib) C Increased Celebrex (Celecoxib) C Mean Cell Volume Zocor (Simvastatin Increased Ratiopharm) C Micturition Disorder Aciphex (Rabeprazole Monocyte Count Increased Sodium) C Motor Dysfunction Hydrochlorothiazide C Neutrophil Count Tylenol Decreased (Paracetamol) C Neutrophil Count Rabeprazole C Increased Simvastatin Penis Disorder "Orifarm" Specific Gravity Urine (Simvastatin Increased Ratiopharm) C Urinary Sediment Present Protoxnix Urine Analysis Abnormal (Pantroprazole) C Vision Blurred Sudafed White Blood Cell Count (Pseudoephedrine Increased Hydrochloride) C Robitussin C Metformin C Risperdal (Risperidone) C Nicorette Gum (Nicotine Resin) C Benalapril (Enalapril) C Nicorette Gum (Nicotine Resin) C Keflex (Cefalexin) C Date:03/30/05ISR Number: 4626533-0Report Type:Expedited (15-DaCompany Report #US_010973409 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicectomy Health Zyprexa-Oral Cholecystitis Infective Professional (Olanzapine) Cholelithiasis (Olanzapine) PS 15 MG/2 DAY Prescribed Overdose Adderal C Weight Increased 24-Jun-2005 12:19 PM Page: 3552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/05ISR Number: 4626534-2Report Type:Expedited (15-DaCompany Report #USA050393329 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 5 MG Representative Date:03/30/05ISR Number: 4626535-4Report Type:Expedited (15-DaCompany Report #USA050393315 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626536-6Report Type:Expedited (15-DaCompany Report #US_0503114189 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Diabetic Coma (Olanzapine) Diabetic Ketoacidosis (Olanzapine) PS Date:03/30/05ISR Number: 4626537-8Report Type:Expedited (15-DaCompany Report #US_0502113422 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626564-0Report Type:Expedited (15-DaCompany Report #US_0409106152 Age:29 YR Gender:Female I/FU:I Outcome PT Hospitalization - Appendicectomy Initial or Prolonged Arthralgia Cellulitis Cold Sweat Diabetes Mellitus Insulin-Dependent Dizziness Feeling Hot Gastrointestinal Disorder Haematoma Hypoaesthesia Infection Ingrowing Nail Intervertebral Disc Protrusion Lower Respiratory Tract Infection Mitral Valve Incompetence Neck Pain Oedema Peripheral Pain 24-Jun-2005 12:19 PM Page: 3553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paraesthesia Rash Refusal Of Examination Report Source Product Role Manufacturer Route Dose Duration Scab Consumer Humalog-Human Sinus Tachycardia Health Insulin (Rdna): Tricuspid Valve Professional 75%Lispro, 25% Npl Incompetence (Li PS 25 U DAY Ventricular Hypertrophy Zyprexa-Oral (Olanzapine) (Olanzapine) SS 10 MG Aspirin (Acetylsalicylic Acid) C Risperdal (Risperidone) C Claritin (Loratadine) C Bextra (Valdecoxib) C Diovan C Naproxen (Naproxen Sodium) C Omnicef (Cefdinir) C Flexeril (Cyclobenzaprine Hydrochloride) C Celexa (Citalopram Hydrobromide) C Keflex (Cefalexin) C Albuterol C Prevacid (Lansoprazole) C Fluticasone C Salmeterol C Singulair (Montelukast) C Wellbutrin (Bupropion Hydrochloride) C Xanax (Alprazolam Dum) C Tizanidine C Glucophage (Metformin) C Date:03/30/05ISR Number: 4626597-4Report Type:Expedited (15-DaCompany Report #USA050392762 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Zyprexa-Oral Increased Professional (Olanzapine) Blood Triglycerides (Olanzapine) PS 5 MG EVERY Increased OTHER DAY Gallbladder Disorder Celexa (Citalopram Hydrobromide) C Questran (Colestyramine) C Fish Oil C 24-Jun-2005 12:19 PM Page: 3554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/05ISR Number: 4626598-6Report Type:Expedited (15-DaCompany Report #USA040258234 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Aggression (Olanzapine) Agitation (Olanzapine) PS 7.5 MG DAY Drug Effect Decreased Feeling Abnormal Insomnia Psychotic Disorder Date:03/30/05ISR Number: 4626599-8Report Type:Expedited (15-DaCompany Report #USA050392887 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Postural Consumer Zyprexa-Oral Initial or Prolonged Insomnia (Olanzapine) Nausea (Olanzapine) PS 40 MG Abilify (Aripiprazole) C Zoloft (Sertraline Hydrochloride) C Date:03/30/05ISR Number: 4626600-1Report Type:Expedited (15-DaCompany Report #USA050393239 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:03/30/05ISR Number: 4626601-3Report Type:Expedited (15-DaCompany Report #US_0407104141 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Back Pain Other Bronchitis Constipation Culture Urine Positive Dermatitis Allergic Dermatitis Atopic Diabetes Mellitus Malnutrition-Related Dizziness Erectile Dysfunction Escherichia Infection Fear Feeling Cold Haemorrhoidal Haemorrhage Headache Hot Flush Hypertension Insomnia Libido Decreased Lipids Increased Lobar Pneumonia Nasopharyngitis 24-Jun-2005 12:19 PM Page: 3555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Obesity Pleurisy Report Source Product Role Manufacturer Route Dose Duration Post-Traumatic Stress Consumer Zyprexa-Oral Disorder Health (Olanzapine) Sepsis Professional (Olanzapine) PS 10 MG/2 DAY Sneezing Depakote (Valproate Urinary Tract Infection Semisodiuim) C Weight Increased Zoloft (Sertraline Hydrochloride) C Pravachol (Pravastatin Sodium) C Diazide (Gliclazide) C Zyban (Bupropion Hydrochloride) C Nicotine Derma Patch (Nicotine Resin) C Allegra (Fexofenadine Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Date:03/31/05ISR Number: 4626750-XReport Type:Expedited (15-DaCompany Report #2005-126695-NL Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Mirtazapine PS ORAL 50 MG ORAL 1 WK Initial or Prolonged Hyponatraemia Olanzapine SS ORAL 2.5 MG ORAL Inappropriate Prednisolone C Antidiuretic Hormone Timolol C Secretion Psychotic Disorder Date:04/01/05ISR Number: 4624884-7Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12905832 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Vasten Tabs 20 Mg PS Bristol-Myers Squibb Company ORAL Theralene SS ORAL 10 WK Vastarel SS ORAL Kardegic SS ORAL Zyprexa SS ORAL 10 weeks and 1 day 10 WK Allopurinol SS ORAL Sepram C Bronchokod C Date:04/01/05ISR Number: 4625511-5Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0295157-00 Age:17 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Pressure Increased Hospitalization - Catatonia Initial or Prolonged Delusion Depressed Level Of 24-Jun-2005 12:19 PM Page: 3556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Electroencephalogram Abnormal Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration Hypervigilance Divalproex Sodium PS ORAL Muscle Rigidity Divalproex Sodium SS Mutism Olanzapine SS ORAL 2.5mg bid, Neuroleptic Malignant 5mg qhs Syndrome Psychomotor Retardation Psychomotor Skills Impaired Rhabdomyolysis Waxy Flexibility Date:04/01/05ISR Number: 4627644-6Report Type:Direct Company Report #CTU 245053 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Olanzapine PS ORAL 5MG QHS ORAL Initial or Prolonged Diabetes Mellitus Olanzapine SS ORAL 5MG Q6H PRN Inadequate Control ORAL Dialysis Hunger Hyperphagia Date:04/01/05ISR Number: 4628008-1Report Type:Expedited (15-DaCompany Report #GXKR2005FR00803 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Allopurinol (Ngx) Health (Allopurinol) Professional Unknown PS ORAL 200 MG, ORAL Other Theralene (Alimemazine Tartrate) SS ORAL ORAL Vastarel (Trimetazidine Hydrochloride) SS ORAL 1 DF, ORAL Kardegic (Acetylsalicylate Lysine) SS ORAL 75 MG, ORAL Zyprexa (Olanzapine) SS 20 MG, DAY Vasten (Pravastatin Sodium) SS 20 MG, DAY Bronchkokod (Carbocisteine) C Date:04/05/05ISR Number: 4627450-2Report Type:Expedited (15-DaCompany Report #US_0411108150 Age:38 YR Gender:Male I/FU:F Outcome PT Hospitalization - Adverse Event Initial or Prolonged Agitation Other Akathisia Anger Angina Pectoris Anxiety Arthralgia 24-Jun-2005 12:19 PM Page: 3557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Glucose Increased Blood Triglycerides Increased Report Source Product Role Manufacturer Route Dose Duration Contusion Consumer Zyprexa-Oral Coronary Artery Occlusion Health (Olanzpine) Delusion Professional (Olanzapine) PS 20 MG/1 AT Diabetes Mellitus BEDTIME Dilatation Atrial Humulin-Human Nph Diplopia Insulin (Rdna) Dizziness Postural (Human Insulin (Rd SS 5 U IN THE Drug Dependence MORNING Drug Screen Positive Humulin-Human Dyspnoea Exertional Regular Insulin Ecchymosis (Rdna) (Human Electrocardiogram T Wave Insulin SS Abnormal Abilify Excoriation (Aripiprazole) C Extrapyramidal Disorder Clozaril (Clozapine) C Facial Pain Seroquel (Quetiapine Feeling Abnormal Fumarate) C Grandiosity Risperdal Hallucination (Risperidone) C Head Injury Geodon (Ziprasidone Headache Hydrochloride) C Hunger Thorazine Hypercholesterolaemia (Chlorpromazine Hypersomnia Hydrochloride) C Hypertension Haldol (Haloperidol Intentional Misuse Decanoate) C Intentional Self-Injury Navane (Tiotixene) C Irritability Depakote (Valproate Laceration Semisodium) C Legal Problem Depakene (Valproate Mania Sodium) C Myocardial Infarction Wellbutrin Neck Pain (Bupropion Nightmare Hydrochloride0 C Physical Assault Lopressor Psychotic Disorder (Metoprolol Qrs Axis Abnormal Tartrate) C Rash Prolixin Refusal Of Treatment By (Fluphenazine Patient Hydrochloride) C Self Injurious Behaviour Cogentin Sexual Dysfunction (Benzatropine Sinus Arrhythmia Mesilate0 C Sleep Apnoea Syndrome Zantac (Ranitidine Snoring Hydrochloride) C Suicidal Ideation Ativan (Lorazepam) C Swelling Glucotrol Xl Syncope (Glipizide) C Treatment Noncompliance Zocor (Simvastatin Tremor Ratiopharm) C Weight Increased Ramipril C Lantus (Insulin Glargine) C Trileptal (Oxcarbazepine) C Vistaril (Hydroxyzine Embonate) C 24-Jun-2005 12:19 PM Page: 3558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Plavix (Clopidogrel Sulfate) C Date:04/05/05ISR Number: 4627458-7Report Type:Expedited (15-DaCompany Report #US_0411107813 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Consumer Zyprexa-Oral Coronary Artery Disease (Olanzapine) Diabetes Mellitus (Olanzapine) PS 10 MG Diabetic Coma Dyslipidaemia Erectile Dysfunction Flashback Hallucination Homicidal Ideation Major Depression Metabolic Syndrome Neurogenic Bladder Neuropathy Peripheral Psychotic Disorder Squamous Cell Carcinoma Suicidal Ideation Date:04/05/05ISR Number: 4627570-2Report Type:Expedited (15-DaCompany Report #2005-126842-NL Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Literature Mirtazapine PS 60 MG QD Consciousness Health Olanzapine SS 10 MG QD Professional Buspirone SS 45 MG BID Clonazepam C 0.25 MG BID Date:04/05/05ISR Number: 4630215-9Report Type:Expedited (15-DaCompany Report #EWC050242659 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Foreign Zyprexa-Oral Diabetic Nephropathy Health (Olanzapine) Diabetic Retinopathy Professional (Olanzapine) PS 10 MG/2 DAY Neuropathy Peripheral Other Largactil (Chlorpromazine Hydrochloride) C Citalopram C Date:04/06/05ISR Number: 4628134-7Report Type:Expedited (15-DaCompany Report #2005005884 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Quilonum Retard PS Glaxosmithkline ORAL 9000MG Single Initial or Prolonged Mydriasis dose Somnolence Zyprexa SS ORAL 75MG Single Suicide Attempt dose Doxepin SS ORAL 2000MG Single dose Ibuprofen SS Glaxosmithkline ORAL 6000MG Single dose 24-Jun-2005 12:19 PM Page: 3559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam SS ORAL 10TAB Single dose Pipamperon SS ORAL 400MG Single dose Alcohol SS ORAL Date:04/06/05ISR Number: 4630214-7Report Type:Expedited (15-DaCompany Report #FR_041004931 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytolytic Hepatitis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG DAY Other Depakote (Valproate Semisodium) C Urbanyl(Clobazam) C Deroxat (Paroxetine Hydrochloride) C Date:04/06/05ISR Number: 4630216-0Report Type:Expedited (15-DaCompany Report #FR_041105285 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Zyprexa-Oral Initial or Prolonged Disturbance In Attention Health (Olanzapine) Muscle Rigidity Professional (Olanzapine) PS Other Laroxyl (Amitriptyline Hydrochloride) C Xanax (Alprazolam Dum) C Aricept (Donepezil Hydrochloride) C Deroxat (Paroxetine Hydrochloride) C Zestoretic C Imipomp (Pantoprazole) C Date:04/06/05ISR Number: 4630217-2Report Type:Expedited (15-DaCompany Report #FR_041105235 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Zyprexa-Oral Hypertriglyceridaemia Health (Olanzapine) Weight Increased Professional (Olanzapine) PS 10 MG DAY Other Date:04/06/05ISR Number: 4630218-4Report Type:Expedited (15-DaCompany Report #FR_050205913 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Guillain-Barre Syndrome Foreign Zyprexa-Oral Initial or Prolonged Influenza Health (Olanzapine) Paresis Professional (Olanzapine) PS Other Praxinor C Parkinane 24-Jun-2005 12:19 PM Page: 3560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Trihexyphenidyl Hydrochloride) C Havlane (Loprazolam Mesilate) C Date:04/06/05ISR Number: 4630219-6Report Type:Expedited (15-DaCompany Report #FR_050105688 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Zyprexa-Oral Initial or Prolonged Phosphatase Increased Health (Olanzapine) Brain Scan Abnormal Professional (Olanzapine) PS 5 MG/1 DAY C-Reactive Protein Other Temesta (Lorazepam) C Increased Allopurinol C Cerebral Atrophy Plavix (Clopidogrel Dysprosody Sulfate) C Electroencephalogram Ivermectin C Abnormal Encephalopathy Eosinophilia Hallucination, Visual Hyperreflexia Lumbar Puncture Abnormal Myoclonus Nervousness Date:04/06/05ISR Number: 4630221-4Report Type:Expedited (15-DaCompany Report #EWC041141420 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Blood Urea Increased Professional (Olanzapine) PS 20 MG/1 DAY Leukaemia Other Stelazine (Trifluoperazine Hydrochloride) C Date:04/06/05ISR Number: 4630229-9Report Type:Expedited (15-DaCompany Report #FR_050305998 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Zyprexa-Oral Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 20 MG DAY Company Representative Other Date:04/06/05ISR Number: 4630232-9Report Type:Expedited (15-DaCompany Report #JP_050306145 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephrotic Syndrome Foreign Zyprexa-Oral Initial or Prolonged Oedema Health (Olanzapine) Oliguria Professional (Olanzapine) PS 10 MG/1 DAY Company Risperdal Representative (Risperidone) C Other 24-Jun-2005 12:19 PM Page: 3561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/05ISR Number: 4630233-0Report Type:Expedited (15-DaCompany Report #JP_050105711 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Oral Other Diabetic Coma Health (Olanzapine) Insomnia Professional (Olanzapine) PS 20 MG DAY Lymph Node Pain Company Risperdal Lymphadenopathy Representative (Risperidone) C Pharyngotonsillitis Other Biperiden C Polydipsia Chlorpromazine C Thirst Flunitrazepam C Fluphenazine Decanoate C Date:04/06/05ISR Number: 4630234-2Report Type:Expedited (15-DaCompany Report #EWC050343285 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Zyprexa-Oral Hyperprolactinaemia Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Other Delorazepam C Valproic Acid C Date:04/06/05ISR Number: 4630235-4Report Type:Expedited (15-DaCompany Report #FR_050306094 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Other Valium (Diazepam) C Date:04/06/05ISR Number: 4630236-6Report Type:Expedited (15-DaCompany Report #JP_050205863 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Foreign Zyprexa-Oral Abnormal Health (Olanzapine) Fall Professional (Olanzapine) PS 20 MG DAY Gaze Palsy Company Levotomin Grand Mal Convulsion Representative (Levomepromazine Loss Of Consciousness Other Maleate) C Partial Seizures Artane Refusal Of Treatment By (Trihexyphenidyl Patient Hydrochloride) C Depas (Etizolam) C Lendormin (Brotizolam) C Lodopin (Zotepine) C Date:04/06/05ISR Number: 4630238-XReport Type:Expedited (15-DaCompany Report #DE_050315501 Age:79 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 24-Jun-2005 12:19 PM Page: 3562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Blood Potassium Decreased Foreign Zyprexa-Oral Cardiac Arrest Health (Olanzapine) Drug Interaction Professional (Olanzapine) PS 5 MG Tachyarrhythmia Other Dipiperon (Pipamperone Hydrochloride) C Date:04/06/05ISR Number: 4630262-7Report Type:Expedited (15-DaCompany Report #GBS050316986 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Olanzapine-Oral Initial or Prolonged Cardiomyopathy Health (Olanzapine) PS 30 MG Professional Citalopram C Other Diazepam C Zopiclone (Zopiclone) C Date:04/06/05ISR Number: 4630276-7Report Type:Expedited (15-DaCompany Report #EWC050343259 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Rapid-Acting Life-Threatening Health Im(Olanzapine) PS 10 MG/2 Professional Mirtazapine C Company Representative Other Date:04/06/05ISR Number: 4630440-7Report Type:Expedited (15-DaCompany Report #USA050290379 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Consumer Forteo Initial or Prolonged Pharmaceutical Product Health (Teriparatide) PS Other Complaint Professional Zyprexa-Oral Pneumonia (Olanzapine) White Blood Cell Count (Olanzapine) SS Increased Diazpem C Tylenol C Aspirin (Acetylsaliyclic Acid) C Lexapro (Escitalopram Oxalate) C Zocor (Simvastatin Ratiopharm) C Wellbutrin (Bupropion Hydrochloride) C Vitamins C Trazadone C Oxycontin (Oxycodone Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/05ISR Number: 4630659-5Report Type:Expedited (15-DaCompany Report #05P-163-0295157-00 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Literature Divalproex Sodium Hospitalization - Body Temperature Health (Depakote) Initial or Prolonged Increased Professional (Divalproex Sodium) Catatonia (Divalproex Sodium) PS ORAL 250 MG, 3 IN Delusion 1 D, ORAL Depressed Level Of Olanzapine SS ORAL 10 MG, ORAL Consciousness Electroencephalogram Abnormal Encephalitis Herpes Heart Rate Increased Hyperhidrosis Hypervigilance Mood Altered Muscle Rigidity Mutism Neuroleptic Malignant Syndrome Paranoia Phagophobia Psychomotor Retardation Psychomotor Skills Impaired Psychotic Disorder Rhabdomyolysis Unresponsive To Verbal Stimuli Waxy Flexibility Date:04/06/05ISR Number: 4630700-XReport Type:Expedited (15-DaCompany Report #US_0502111957 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Consumer Zyprexa-Oral Initial or Prolonged Cystocele Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 20 MG/1 AT Haematemesis BEDTIME Hernia Repair Symbyax C Pancreatitis Alprazolam C Rectal Prolapse Repair Wellbutrin Sneezing (Bupropion Urinary Incontinence Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Trazadone (Trazodone) C Amaryl (Glimepiride) C Tenormin (Atenolol Eg) C Valium (Diazepam) C Prevacid (Lansoprazole) C Propulsid (Cisapride) C Centrum C Ambien (Zolpidem Tartrate) C 24-Jun-2005 12:19 PM Page: 3564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Zithromax (Azithromycin) C Estrace (Estradiol) C Tricor (Fenofibrate) C Zetia (Ezetimibe) C Prilosec (Omeprazole Ratiopharm) C Pravachol (Pravastatin Sodium) C Lopid (Gemfibrozil) C Crestor (Rosuvastatin Calcium) C Date:04/06/05ISR Number: 4630763-1Report Type:Expedited (15-DaCompany Report #US_0409106152 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Consumer Humalog-Human Initial or Prolonged Arthralgia Health Insulin (Rdna): 75% Cellulitis Professional Lisptro, 25% Npl (Li PS 25 U DAY Cold Sweat Zyprexa-Oral Diabetes Mellitus (Olanzapine) Insulin-Dependent (Olanzapine) SS 10 MG Dizziness Aspirin Feeling Hot (Acetylsalicylic Gastrointestinal Disorder Acid) C Haematoma Risperdal Hyperlipidaemia (Risperidone) C Hypoaesthesia Claritin Ingrowing Nail (Loratadine) C Intervertebral Disc Bextra (Valdecoxib) C Disorder Diovan C Loss Of Consciousness Naproxen (Naproxen Menorrhagia Sodium) C Metabolic Disorder Omnicef (Cefdinir) C Mitral Valve Incompetence Flexeril Nasopharyngitis (Cyclobenzaprine Neck Pain Hydrochloride) C Oedema Peripheral Celexa (Citalopram Pain Hydrobromide) C Paraesthesia Keflex (Cefalexin) C Rash Albuterol C Refusal Of Examination Prevacid Scab (Lansoprazole) C Sinus Tachycardia Fluticasone C Tricuspid Valve Salmeterol C Incompetence Singulair Ventricular Hypertrophy (Montelukast) C Wellbutrin (Bupropion Hydrochloride) C Xanax (Alprazolam Dum) C Tizanidine C Glucophage (Metformin) C Darvocet-N C Soma (Carisoprodol) C 24-Jun-2005 12:19 PM Page: 3565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/05ISR Number: 4630890-9Report Type:Expedited (15-DaCompany Report #USA050393602 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) Other (Olanzapine) PS 10 MG/1 DAY Date:04/06/05ISR Number: 4631010-7Report Type:Expedited (15-DaCompany Report #US_0503113579 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:04/06/05ISR Number: 4631025-9Report Type:Expedited (15-DaCompany Report #USA020414476 Age:39 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anger Initial or Prolonged Anxiety Disability Attention Other Deficit/Hyperactivity Disorder Bladder Disorder Bronchospasm Condition Aggravated Cough Crying Dehydration Diabetes Mellitus Diplopia Dry Mouth Feeling Abnormal Feeling Guilty Feeling Jittery Feelings Of Worthlessness Hallucination, Auditory Headache Hypertriglyceridaemia Hypoaesthesia Insomnia Job Dissatisfaction Lethargy Loss Of Employment Major Depression Middle Insomnia Neurogenic Bladder Nightmare Obsessive-Compulsive Disorder Psychiatric Symptom Psychotic Disorder Self Esteem Decreased Sexual Dysfunction Sinus Bradycardia Social Avoidant Behaviour Somnolence Suicidal Ideation 24-Jun-2005 12:19 PM Page: 3566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Tinea Pedis Vertigo Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Consumer Zyprexa-Oral Weight Decreased Health (Olanzapine) Wheezing Professional (Olanzapine) PS 5 MG AT BEDTIME Paxil (Paroxetine Hydrochloride) C Concerta (Methylphenidate Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Ditropan (Oxybutynin Hydrochloride) C Haldol (Haloperidol Decanoate) C Cogentin (Benzatropine Mesilate) C Glucophage (Metformin) C Ativan (Lorazepam) C Depakote (Valproate Semisodium) C Niaspan (Nicotonic Acid) C Risperidone C Singulair (Montelukast) C Lamictal (Lamotrigine) C Tolterodine L-Tartrate C Seroquel (Quetiapine Fumarate) C Celebrex (Celecoxib) C Clonazepam C Date:04/06/05ISR Number: 4631028-4Report Type:Expedited (15-DaCompany Report #US_0503114703 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:04/06/05ISR Number: 4631029-6Report Type:Expedited (15-DaCompany Report #US_0503114722 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Company Zyprexa-Oral Murder Representative (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/05ISR Number: 4631031-4Report Type:Expedited (15-DaCompany Report #US_0503113776 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Balance Disorder (Olanzapine) Other Cerebral Atrophy (Olanzapine) PS 10 MG AT Confusional State BEDTIME Cough Synthroid Diabetes Mellitus (Levothyroxine Hypersomnia Sodium) C Hypoventilation Singulair Hypoxia (Montelukast) C Lethargy Allegra Mental Impairment (Fexofenadine Urinary Tract Infection Hydrochloride) C Glucovance C Allopurinol C Lipitor (Atorvastatin Calcium) C Lisinopril (Lisinopril) C Avandia (Rosiglitazone Maleate) C Lithobid (Lithium Carbonate) C Dalmane (Flurazepam Hydrochloride) C Depakote (Valproate Semisodium) C Trazodone C Date:04/06/05ISR Number: 4631045-4Report Type:Expedited (15-DaCompany Report #US_0503114698 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:04/06/05ISR Number: 4631047-8Report Type:Expedited (15-DaCompany Report #USA050393741 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Company Zyprexa-Oral Initial or Prolonged Platelet Count Decreased Representative (Olanzapine) Other (Olanzapine) PS 10 MG DAY Date:04/06/05ISR Number: 4631049-1Report Type:Expedited (15-DaCompany Report #USA050393595 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Company Zyprexa-Oral Representative (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/05ISR Number: 4631051-XReport Type:Expedited (15-DaCompany Report #USA050393693 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Zyprexa-Oral Hospitalization - Fall (Olanzapine) Initial or Prolonged Subdural Haematoma (Olanzapine) PS 7 YR Therapy Non-Responder Date:04/06/05ISR Number: 4631054-5Report Type:Expedited (15-DaCompany Report #US_0501110653 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketoacidosis Consumer Zyprexa-Oral Pancreatitis (Olanzapine) (Olanzapine) PS Date:04/06/05ISR Number: 4631065-XReport Type:Expedited (15-DaCompany Report #US_0405103315 Age:39 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Adenoma Benign Other Alcoholism Anxiety Arthralgia Blood Cholesterol Increased Blood Glucose Increased Blood Triglycerides Increased Chest Pain Contusion Costochondritis Difficulty In Walking Dilatation Atrial Disturbance In Attention Drug Abuser Dyspnoea Ear Pain Ejection Fraction Decreased Electrocardiogram Abnormal Gait Disturbance Gingival Pain Glycosylated Haemoglobin Increased Hallucination, Auditory Headache Hypoaesthesia Local Swelling Major Depression Mitral Valve Incompetence Neck Pain Nervousness Oedema Peripheral Pain In Jaw Somnolence Suicidal Ideation 24-Jun-2005 12:19 PM Page: 3569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Swelling Tremor Tricuspid Valve Report Source Product Role Manufacturer Route Dose Duration Incompetence Consumer Zyprexa-Oral Ventricular Hypertrophy Health (Olanzapine) Weight Increased Professional (Olanzapine) PS 12.5 MG/1 AT BEDTIME Zoloft (Sertraline Hydrochlride) C Glucophage Xr (Metformin Hydrochloride) C Zocor (Simvastatin Ratiopharm) C Lipitor (Atorvastatin Calcium) C Verapamil C Aspirin (Acetylsalicylic Acid) C Multivitamin C Haldol (Haloperidol Decanoate) C Paxil (Paroxetine Hydrochloride) C Advicor C Colace (Docusate Sodium) C Cozaar (Losartan Potassium) C Allegra (Fexofenadine Hydrochloride) C Lorcet Plus C Tylenol With Codeine C Darvocet-N 100 C Ultram (Tramadol Hydrochloride) C Risperdal (Risperidone) C Percocet C Vicodin C Nasocort (Budesonide) C Cogentin (Benzaropine Mesilate) C Ativan (Lorazepam) C Tranxene (Clorazepate Dipotassium) C Surbex-T C Mylanta C Milk Of Magnesia C Aripiprazole C Clorazepate Dipotassium C Thiamine Hydrochloride C Benadryl C 24-Jun-2005 12:19 PM Page: 3570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flonase (Fluticasone Propionate) C Date:04/06/05ISR Number: 4631074-0Report Type:Expedited (15-DaCompany Report #US_0409105409 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Zyprexa-Oral Initial or Prolonged Back Pain Health (Olanzapine) Blood Cholesterol Professional (Olanzapine) PS 10 MG DAY Abnormal 12mg/50mg Blood Cholesterol Olanzipine/Fluoxetin Increased e Capsule C Blood Creatine Celexa (Citalopram Phosphokinase Increased Hydrobromide) C Blood Triglycerides Anafranil Increased (Clomipramine Cellulitis Hydrochloride) C Chest Discomfort Lotrel C Chest Pain Prednisolone C Depression Prednisone Diabetes Mellitus (Prednisone) C Non-Insulin-Dependent Hydrochlorothiazide C Dyspnoea Viagra (Sildenafil Electrocardiogram Citrate) C Abnormal Darvocet-N C Erectile Dysfunction Aspirin Gastrooesophageal Reflux (Acetylsalicylic Disease Acid) C Headache Zyrtec (Cetirizine Hyperglycaemia Hydrochloride) C Hypoaesthesia Nasonex (Mometasone Joint Sprain Furoate) C Myocardial Infarction Allegra Oedema Peripheral (Fexofenadine Pain In Extremity Hydrochloride) C Sinus Disorder Desloratadine C Sleep Disorder Rabeprazole C Weight Increased Nitroglycerin (Glyceryl Trinitrate) C Tricor (Fenofibrate) C Zithromax Z-Pack (Azithromycin) C Augmentin C Amoxicillin C Clobetasol C Meperidine C Claritin (Loratadine) C Actos (Pioglitazone Hydrochloride) C Naproxen Sodium C 24-Jun-2005 12:19 PM Page: 3571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/05ISR Number: 4631076-4Report Type:Expedited (15-DaCompany Report #USA041287013 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa-Oral Lymphocyte Percentage Professional (Olanzapine) Increased Company (Olanzapine) PS Neutrophil Percentage Representative Decreased Date:04/06/05ISR Number: 4631082-XReport Type:Expedited (15-DaCompany Report #US_0405102840 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Zyprexa-Oral Abnormal Faeces Health (Olanzapine) Alpha 1 Foetoprotein Professional (Olanzapine) PS 15 MG DAY Increased Zoloft (Sertraline Anaemia Hydrochloride) C Asthenia Desyrel (Trazodone Blood Albumin Decreased Hydrochloride) C Carcinoembryonic Antigen Rebetron C Increased Interferon C Diarrhoea Ribavirin C Feeling Abnormal Dolobid (Diflunisal) C Gastritis Imferon (Iron Hepatic Cirrhosis Dextran) C Hepatic Failure Nexium (Esomeprazole Hepatic Steatosis Magnesium) C Hepatitis C Ibuprofen C Hiatus Hernia Tramadol C Macrocytosis Mania Medication Error Oesophagitis Pancytopenia Physical Assault Protein Total Decreased Theft Varices Oesophageal Date:04/06/05ISR Number: 4631322-7Report Type:Expedited (15-DaCompany Report #US_0503114589 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Olanzapine-Long-Acti Initial or Prolonged Confusional State Health ng Im (Depot) PS 390 MG Disorientation Professional Irritability Loss Of Consciousness Musculoskeletal Stiffness Pyrexia Sedation Somnolence 24-Jun-2005 12:19 PM Page: 3572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/05ISR Number: 4631323-9Report Type:Expedited (15-DaCompany Report #US_0503114606 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Study Olanzapine-Long-Acti Initial or Prolonged Condition Aggravated Health ng Im (Depot) PS 210 MG Schizophrenia, Professional Undifferentiated Type Date:04/06/05ISR Number: 4631326-4Report Type:Expedited (15-DaCompany Report #US_0503113803 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Zyprexa-Oral Akathisia Health (Olanzapine) Anxiety Professional (Olanzapine) PS 5 MG Comminuted Fracture Paxil (Paroxetine Completed Suicide Hydrochloride) C Conversion Disorder Delusion Depressed Mood Feeling Abnormal Feeling Of Despair Gun Shot Wound Head Injury Nervousness Paranoia Tearfulness Date:04/06/05ISR Number: 4631337-9Report Type:Expedited (15-DaCompany Report #US_0412109481 Age:39 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Accidental Overdose Other Anxiety Aortic Valve Incompetence Blood Albumin Decreased Blood Potassium Decreased Blood Triglycerides Increased Body Temperature Decreased Condition Aggravated Decreased Appetite Dehydration Depression Dermatitis Contact Hepatic Enzyme Abnormal Herpes Simplex Hyperosmolar State Hypertension Hypokalaemia Hyponatraemia Intentional Misuse Irritability Joint Swelling Malnutrition Nausea Pancreatitis Acute 24-Jun-2005 12:19 PM Page: 3573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Periorbital Oedema Pruritus Pyoderma Report Source Product Role Manufacturer Route Dose Duration Sinus Bradycardia Consumer Zyprexa-Oral Skin Laceration Health (Olanzapine) Skin Lesion Professional (Olanzapine) PS 10 MG AT Suicide Attempt BEDTIME Supraventricular Prozac-Oral Extrasystoles (Fluoxetine)(Fluoxet Swollen Tongue ine Hydrochloride) SS 40 MG IN THE Vomiting MORNING Weight Decreased Zyprexa -Dispersible Weight Increased (Olanzapine) Wound Secretion (Olanzapine) SS 10 MG Lexapro (Escitalopram Oxalate) C Trazodone C Visatril (Hydroxyzine Embonate) C Atenolol C Hydrocet C Esgic-Plus C Ranitidine C Phenergan (Promethazine Hydrochloride) C Alprazolam C Regular (Metoclopramide Hydrochloride) C Remeron (Mirthazapine Orifarm) C Neurontin (Gabapentin Pfizer) C Norco C Phrenilin Forte C Ultram 9tramadol Hydrochlofide) C Lortab C Quinine C Lasix (Furosemide) C Klonopin (Clonazepam) C Xanax (Alprazolam Dum) C Zebutal C Diphenhydramine C Lorazepam C Famotidine C Date:04/07/05ISR Number: 4629690-5Report Type:Expedited (15-DaCompany Report #CA_050107645 Age:33 YR Gender:Male I/FU:F Outcome Death Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 3574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Brain Oedema Foreign Zyprexa-Oral Convulsion Health (Olanzapine) Status Epilepticus Professional (Olanzapine) PS 10 MG Company Paxil (Paroxetine Representative Hydrochloride) C Other Date:04/07/05ISR Number: 4629742-XReport Type:Expedited (15-DaCompany Report #JP_031001983 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Zyprexa Hospitalization - Phosphokinase Increased Literature (Olanzapine) PS ORAL 10 MG DAY Initial or Prolonged Crackles Lung Health Serence Other Decreased Appetite Professional (Haloperidol) C Diabetic Coma Company Diabetic Ketoacidosis Representative Haemodialysis Other Hyperventilation Hypotension Inflammation Nausea Obesity Pneumonia Staphylococcal Renal Failure Acute Respiratory Rate Increased Staphylococcal Infection Tachycardia Urinary Tract Infection Vomiting Date:04/07/05ISR Number: 4631474-9Report Type:Expedited (15-DaCompany Report #HQWYE649504APR05 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Efexor (Venlafaxine Initial or Prolonged Suicidal Ideation Professional Hydrochloride, Other Tablet) PS ORAL SEE IMAGE Olanzapine (Olanzapine) SS Date:04/08/05ISR Number: 4630081-1Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-04P-062-0277956-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Akineton PS ORAL Initial or Prolonged Disturbance In Attention Lorazepam SS ORAL Suicide Attempt Doxepin SS ORAL Olanzapine SS ORAL Buspirone Hydrochloride SS ORAL Fluphenazine Hydrochloride SS ORAL Carbamazepine SS ORAL 24-Jun-2005 12:19 PM Page: 3575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/05ISR Number: 4633870-2Report Type:Expedited (15-DaCompany Report #04P-062-0277956-00 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Akineton (Biperiden) Initial or Prolonged Disturbance In Attention Health (Biperiden) PS ORAL PER ORAL Suicide Attempt Professional Lorazepam SS ORAL PER ORAL Doxepin SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Buspirone Hydrochloride SS ORAL PER ORAL Fluphenazine Hydrochloride SS ORAL PER ORAL Carbamazepine SS ORAL PER ORAL Date:04/11/05ISR Number: 4635033-3Report Type:Expedited (15-DaCompany Report #2005051613 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Olanzapine Other Company (Olanzapine) SS Representative Date:04/12/05ISR Number: 4633121-9Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0365152A Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Lamictal PS Glaxosmithkline ORAL Initial or Prolonged Disorientation Floxyfral SS ORAL 50MG Per day 3 DAY Trittico SS ORAL 200MG Per day 3 DAY Zyprexa SS ORAL 5MG Per day 3 DAY Bactrim Forte C Glaxosmithkline ORAL Blopress C ORAL 16MG Per day 3 DAY Date:04/12/05ISR Number: 4633358-9Report Type:Expedited (15-DaCompany Report #2005-127096-NL Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Mirtazapine PS DF Initial or Prolonged Phosphokinase Increased Amisulpride SS 400 MG 1 WK Blood Pressure Olanzapine SS DF Fluctuation Citalopram SS DF Extrapyramidal Disorder Zopiclone SS DF Feeling Abnormal Hyperhidrosis Parkinsonism Pyrexia Weight Decreased Date:04/12/05ISR Number: 4633377-2Report Type:Expedited (15-DaCompany Report #HQWYE648004APR05 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Efexor (Venlafaxine Initial or Prolonged Akathisia Health Hydrochloride, Homicidal Ideation Professional Tablet) PS ORAL ORAL Suicidal Ideation Other Zyprexa 24-Jun-2005 12:19 PM Page: 3576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine,) SS Date:04/12/05ISR Number: 4634414-1Report Type:Expedited (15-DaCompany Report #2004081893 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS INTRAMUSCULAR 160 MG (80 Life-Threatening Body Temperature Professional MG, 2 IN 1 D) Hospitalization - Increased Company Olanzapine Initial or Prolonged Heart Rate Increased Representative (Olanzapine) SS Intentional Self-Injury All Other Neuroleptic Malignant Therapeutic Products Syndrome (All Other Ventricular Tachycardia Therapeutic Products) C Date:04/12/05ISR Number: 4634868-0Report Type:Expedited (15-DaCompany Report #EWC050242659 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Foreign Zyprexa-Oral Diabetic Nephropathy Health (Olanzapine) Diabetic Retinopathy Professional (Olanzapine) PS 10 MG/2 DAY Glycosylated Haemoglobin Other Largactil Increased (Chlorpromazine Neuropathy Peripheral Hydrochloride) C Citalopram C Date:04/13/05ISR Number: 4635426-4Report Type:Expedited (15-DaCompany Report #04-11-1631 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets - Cardiomegaly Professional Ivax Hypothyroidism Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Zyprexa SS ORAL 7.5MG BID ORAL/MONTHS Levothyroxine C Diazepam C Date:04/13/05ISR Number: 4635825-0Report Type:Expedited (15-DaCompany Report #US_0407104133 Age:49 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Amnesia Other Asthma Blood Pressure Increased Cardiac Disorder Diabetes Mellitus Emotional Distress Loss Of Consciousness Nausea Pain Screaming 24-Jun-2005 12:19 PM Page: 3577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 20 MG Paxil (Paroxetine Hydrochloride) C Glucophage (Metformin) C Hyzaar C Albuterol C Flovent (Fluticasone Propionate) C Viox (Rofecoxib) C Zanaflex (Tizanidine Hydrochloride) C Neurontin (Gabapentin Pfizer) C Norvasc (Amlodipine) C Buspirone C Diphenhydramine C Nifedipine C Enalapril Maleate C Serevent Diskus (Salmeterol Xinafoate) C Celebrex (Celecoxib0 C Cyclobenzaprine C Date:04/13/05ISR Number: 4635826-2Report Type:Expedited (15-DaCompany Report #US_0502112990 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:04/13/05ISR Number: 4635837-7Report Type:Expedited (15-DaCompany Report #USA050394170 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Consumer Zyprexa-Oral Balance Disorder (Olanzapine) Chapped Lips (Olanzapine) PS 10 MG Dizziness Abilify (Ariprazole) C Epistaxis Lithium C Muscle Spasms Acetaminophen C Musculoskeletal Stiffness Klonopin Paraesthesia (Clonazepam) C Stomach Discomfort Thirst Weight Increased 24-Jun-2005 12:19 PM Page: 3578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/05ISR Number: 4635730-XReport Type:Expedited (15-DaCompany Report #JP_050406288 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Foreign Zyprexa-Oral Initial or Prolonged Study (Olanzapine) Health (Olanzapine) PS 20 MG DAY Professional Halomonth (Haloperidol Decanoate) C Akiriden (Biperiden Hydrochloride) C Flunitrazepam C Date:04/14/05ISR Number: 4635760-8Report Type:Expedited (15-DaCompany Report #DSA_26217_2005 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Tavor PS ORAL 10 MG ONCE PO Initial or Prolonged Sopor Health Lendormin SS ORAL 5 MG ONCE PO Tachycardia Professional Zolpidem SS ORAL 100 MG ONCE Other PO Zyprexia SS ORAL 135 MG ONCE PO Date:04/14/05ISR Number: 4636704-5Report Type:Expedited (15-DaCompany Report #2005052957 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Self-Medication Health Geodon (Ziprasidone) PS Professional Bupropion Company Hydrochloride Representative (Bupropion Hydrochloride) SS Olanzapine/Fluoxetin e Hydrochloride (Fluoxetine Hydrochloride, Olanzapine) SS Mirtazapine (Mirtazepine) SS Obetrol (Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, SS Date:04/15/05ISR Number: 4638029-0Report Type:Expedited (15-DaCompany Report #2005-04-0156 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Aerius Initial or Prolonged Drug Dependence Health (Desloratadine) Professional Tablets PS ORAL ORAL Other Atarax SS Tercian SS Valium SS Zyprexa (Olanzapine) SS 24-Jun-2005 12:19 PM Page: 3579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/05ISR Number: 4638052-6Report Type:Expedited (15-DaCompany Report #US_0411108150 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Agitation Health (Olanzapine) Other Akathisia Professional (Olanzapine) PS 20 MG/1 AT Alcoholism BEDTIME Anxiety Humulin-Human Nph Arthralgia Insulin (Rdna) Bipolar Disorder (Human Insulin (Rd SS 5 U IN THE Blood Glucose Increased MORNING Blood Triglycerides Humulin-Human Increased Regular Insulin Contusion (Rdna) (Human Coronary Artery Occlusion Insulin SS Delusion Abilify Dilatation Atrial (Aripirazole) C Diplopia Clozaril (Clozapine) C Drug Dependence Seroquel (Quetiapine Drug Screen Positive Fumarate) C Dyslipidaemia Risperdal Dyspepsia (Risperidone) C Ecchymosis Geodon (Ziprasidone Electrocardiogram T Wave Hydrochloride) C Abnormal Thorazine Excoriation (Chlorpromazine Extrapyramidal Disorder Hydrochloride) C Facial Pain Haldol (Haloperidol Grandiosity Decanoate) C Hallucination Navane (Tiotixene) C Headache Depakote (Valproate Hunger Semisodium) C Hypersomnia Depakene (Valproate Hypertension Sodium) C Hypomania Wellbutrin Intentional Self-Injury (Bupropion Legal Problem Hydrochloride) C Multiple Drug Overdose Lopressor Myocardial Infarction (Metoprolol Neck Pain Tartrate) C Nightmare Prolixin Paranoia (Fluphenazine Physical Assault Hydrochloride) C Polydipsia Cogentin Psychotic Disorder (Benzatropine Qrs Axis Abnormal Mesilate) C Rash Zantac (Ranitidine Refusal Of Treatment By Hydrochloride) C Patient Ativan (Lorazepam) C Schizoaffective Disorder Glucotrol Xl Sexual Dysfunction (Glipizide) C Shoulder Pain Zocor (Simvastatin Sinus Arrhythmia Ratiopharm) C Skin Laceration Ramipril C Sleep Apnoea Syndrome Lantus (Insulin Snoring Glargine) C Suicidal Ideation Lopressor Swelling (Metoprolol Syncope Tartrate) C Tremor Trileptal Weight Increased (Oxcarbazepine) C 24-Jun-2005 12:19 PM Page: 3580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vistaril (Hydroxyzine Embonate) C Plavix (Clopidogrel Sulfate) C Date:04/15/05ISR Number: 4638054-XReport Type:Expedited (15-DaCompany Report #US_0406103928 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zyprexa-Oral Initial or Prolonged Alanine Aminotransferase Health (Olanzapine) Other Increased Professional (Olanzapine) PS 20 MG AT Anion Gap Increased BEDTIME 4 YR Beta Haemolytic Lithium C Streptococcal Infection Symmetrel Blood Alkaline (Amantadine Phosphatase Increased Hydrochloride) C Blood Calcium Decreased Ativan (Lorazepam) C Blood Chloride Decreased Vioxx (Rofecoxib) C Blood Sodium Decreased Celebrex (Celecoxib) C Blood Triglycerides Zocor (Simvastatin Increased Ratiopharm) C Diabetes Mellitus Aciphex (Rabeprazole Diabetic Ketoacidosis Sodium) C Globulins Increased Hydrochlorothiazide C High Density Lipoprotein Tylenol Decreased (Paracetamol) C Mean Cell Haemoglobin Rabeprazole C Concentration Increased Simvastatin Monocyte Count Increased "Orifarm" Motor Dysfunction (Simvastatin Neutrophil Count Ratiopharm) C Increased Protonix Penile Infection (Pantoprazole) C Rectal Lesion Sudafed Vision Blurred (Pseudoephedrine White Blood Cell Count Hydrochloride) C Increased Robitussin C Metformin C Risperdal (Risperidone) C Nicorette Gum (Nicotine Resin) C Benalapril (Enalapril) C Nicorette Gum (Nicotine Resin) C Keflex (Cefalexin) C Date:04/15/05ISR Number: 4638162-3Report Type:Expedited (15-DaCompany Report #USA050289604 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Zyprexa-Oral Initial or Prolonged Professional (Olanzapine) Other Company (Olanzapine) PS 30 MG DAY Representative Paxil (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topamax (Topiramate) C Xanax (Alprazolam Dum) C Vicodin C Restoril (Temazepam) C Lipitor (Atorvastatin Calcium) C Lortab C Keppra (Levetiracetam) C Zonegran (Zonisamide) C Corgard (Nadolol) C Date:04/15/05ISR Number: 4638188-XReport Type:Expedited (15-DaCompany Report #USA050291129 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Symbyax Initial or Prolonged Mania Professional Olanzapine 6mg Other Obesity Company / Fluoxetine 25mg PS ORAL Pneumonia Representative Zyprexa Pulmonary Embolism Weight Increased (Olanzapine) SS ORAL 5 MG/1 DAY Topamax (Topiramate) C Vytorin C Date:04/15/05ISR Number: 4638228-8Report Type:Expedited (15-DaCompany Report #USA050394104 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Health Zyprexa-Oral Pregnancy Professional (Olanzapine) Neonatal Respiratory (Olanzapine) PS Depression Lithium C Date:04/15/05ISR Number: 4638244-6Report Type:Expedited (15-DaCompany Report #USA050394124 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Zyprexa-Dispersible Initial or Prolonged Disturbance In Social Professional (Olanzapine) Behaviour (Olanzapine) PS 2.5 MG/1 AT Drug Interaction BEDTIME Hallucination Zyprexa-Oral Psychotic Disorder (Olanzapine) Regressive Behaviour (Olanzapine) SS 20 MG/1 AT Schizophrenia BEDTIME Staring Geodon (Ziprasidone Hydrochloride) C Ativan (Lorazepam) C 24-Jun-2005 12:19 PM Page: 3582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/05ISR Number: 4638351-8Report Type:Expedited (15-DaCompany Report #EWC050443404 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Foreign Zyprexa-Oral Decreased Health (Olanzapine) Professional (Olanzapine) PS 10 MG/ 1 IN Other THE EVENING Diazepam C Date:04/15/05ISR Number: 4638352-XReport Type:Expedited (15-DaCompany Report #JP_050406286 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Oral Study (Olanzapine) Health (Olanzapine) PS 20 MG DAY Professional Lullan (Perospirone Other Hydrochloride) C Akiriden (Biperiden Hydrochloride) C Vegetamin B C Date:04/15/05ISR Number: 4638396-8Report Type:Expedited (15-DaCompany Report #EWC050343070 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Zyprexa Increased Health Metabolic Syndrome Professional (Olanzapine) PS ORAL 5 MG Weight Increased Other Fluctin (Fluoxetine Hydrochloride) SS ORAL 20 MG Date:04/15/05ISR Number: 4639925-0Report Type:Expedited (15-DaCompany Report #FR_050105649 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zyprexa-Rapid-Acting Initial or Prolonged Incorrect Route Of Drug Health Im (Olanzapine) PS 10 MG/1 HOUR Administration Professional Loxapac Loxapine Injection Site Erythema Other Succinate) C Sinus Tachycardia Date:04/15/05ISR Number: 4639942-0Report Type:Expedited (15-DaCompany Report #FR_050306133 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cytolytic Hepatitis Foreign Zyprexa-Oral Initial or Prolonged Self Mutilation Health (Olanzapine) Professional (Olanzapine) PS 15 MG DAY Company Representative Other 24-Jun-2005 12:19 PM Page: 3583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/05ISR Number: 4639943-2Report Type:Expedited (15-DaCompany Report #DE_050315532 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Zyprexa-Oral Hospitalization - Phosphokinase Increased Health (Olanzapine) Initial or Prolonged C-Reactive Protein Professional (Olanzapine) PS 10 MG DAY Increased Other Akineton Retard Pyrexia (Biperiden Somnolence Hydrochloride) C Transaminases Increased Tremor Date:04/15/05ISR Number: 4639944-4Report Type:Expedited (15-DaCompany Report #GBS050216720 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Olanzapine-Oral Initial or Prolonged Confusional State Health (Olanzapine) PS Other Mania Professional Other Date:04/15/05ISR Number: 4639953-5Report Type:Expedited (15-DaCompany Report #JP_050306214 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa-Oral Initial or Prolonged Chemical Poisoning Study (Olanzapine) Suicide Attempt Health (Olanzapine) PS 10 MG DAY Professional Levomepromazine C Other Flunitrazepam C Sennoside (Sennoside A+B Calcium) C Date:04/18/05ISR Number: 4637664-3Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0046106A Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Quilonum Retard PS Glaxosmithkline ORAL 225MG per day 73 DAY Initial or Prolonged Masked Facies Zyprexa SS ORAL 53 DAY Parkinsonian Gait Molsidomin C ORAL 8MG per day Parkinsonism Isdn C Ass C Glaxosmithkline ORAL 100MG per day Zocor C ORAL 20MG per day 267 DAY Propra Ratiopharm C ORAL 30MG per day 292 DAY Favistan C ORAL 1TAB per day 278 DAY Seroquel C UNKNOWN Leponex C UNKNOWN Date:04/18/05ISR Number: 4637830-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12925129 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Aripiprazole PS Otsuka Hospitalization - Asphyxia Pharmaceutical Initial or Prolonged Weight Increased Company, Ltd. UNKNOWN Zyprexa SS ORAL Zopiclone C UNKNOWN 24-Jun-2005 12:19 PM Page: 3584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/05ISR Number: 4638193-3Report Type:Expedited (15-DaCompany Report #USA050394465 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Consumer Zyprexa Initial or Prolonged Pregnancy Health Dyskinesia Neonatal Professional (Olanzapine) PS TRANSPLACENTAL Feeding Problem In Effexor Newborn Hypotonia Neonatal (Venlafaxine Hydrochloride) C TRANSPLACENTAL Date:04/18/05ISR Number: 4638196-9Report Type:Expedited (15-DaCompany Report #US_0504114918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Consumer Zyprexa Other (Olanzapine) PS Date:04/18/05ISR Number: 4638198-2Report Type:Expedited (15-DaCompany Report #USA050393950 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercalcaemia Consumer Zyprexa Initial or Prolonged (Olanzapine) PS ORAL 10 MG DAY Date:04/18/05ISR Number: 4638201-XReport Type:Expedited (15-DaCompany Report #US_0411107842 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Zyprexa Initial or Prolonged Increased Health (Olanzapine) PS 60 MG Other Arrhythmia Professional Seroquel Blood Alkaline Distributor (Quetiapine Phosphatase Increased Fumarate) C Chest Pain Risperdal Condition Aggravated (Risperidone) C Diabetes Mellitus Haldol (Haloperidol Diabetic Ketoacidosis Decanoate) C Diabetic Nephropathy Depakote (Valproate Essential Hypertension Semisodium) C Glycosuria Lithium C Haematemesis Paxil (Paroxetine Hallucination, Auditory Hydrochloride) C Hypertension Glyburide C Insomnia Metformin C Joint Swelling Insulin C Labyrinthitis Accuretic C Metabolic Acidosis Mirtazapine C Obesity Lisinopril Proteinuria (Lisinopril) C Renal Failure Valsartan C Tachycardia Quinapril C Ulcer Haemorrhage Hydrochlorothiazide/ Vision Blurred Triameterene C Weight Decreased White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 3585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/05ISR Number: 4638247-1Report Type:Expedited (15-DaCompany Report #USA050394591 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Symbyax-Olanzapine 6 Professional Mg/ Fluoxetine 25 Mg Company (Olanzapine PS Representative Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Date:04/18/05ISR Number: 4638685-7Report Type:Direct Company Report #CTU 246393 Age:61 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Olanzapine PS ORAL 15 MG PO Depression DAILY Suicidal Ideation Date:04/18/05ISR Number: 4639158-8Report Type:Expedited (15-DaCompany Report #200510962GDS Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Ciproxin Initial or Prolonged Drug Withdrawal Syndrome Health (Ciprofloxacin) PS ORAL 500 MG, BID, Neuroleptic Malignant Professional ORAL Syndrome Other Zyprexa (Olanzapine) SS ORAL 5 MG, TOTAL Prostatitis DAILY, ORAL Psychotic Disorder Esomeprazol C Tramadol C Lorazepam C Nadroparin C Date:04/19/05ISR Number: 4639108-4Report Type:Expedited (15-DaCompany Report #ES-NOVOPROD-243401 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Novonorm PS Novo Nordisk A/S ORAL 1 Tab, qd 28800MIN Initial or Prolonged Depakine SS ORAL 1.2 g, qd 30240MIN Seroxat "Smithkline Beecham" SS ORAL 20 mg, qd 18720MIN Zyprexa SS ORAL .05 mg, qd 11520MIN Date:04/20/05ISR Number: 4640246-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0502021A Age:9 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Other Agitation Anger Anorexia Arrhythmia Bradycardia Cognitive Disorder Depression Dystonia 24-Jun-2005 12:19 PM Page: 3586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eye Rolling Fear Mood Swings Report Source Product Role Manufacturer Route Dose Duration Myalgia Paxil PS Glaxosmithkline ORAL 30MG Per day Nightmare Zoloft SS ORAL 25MG Three Pain In Extremity times per day Self Mutilation Zyprexa SS Suicidal Ideation Suicide Attempt Swollen Tongue Tachycardia Date:04/20/05ISR Number: 4640362-3Report Type:Periodic Company Report #165540 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sluggishness Lithium PS Glaxosmithkline UNKNOWN Zyprexa SS Date:04/20/05ISR Number: 4641572-1Report Type:Expedited (15-DaCompany Report #US_0504115233 Age:40 YR Gender:Female I/FU:I Outcome PT Other Accidental Exposure Anaemia Asthenia Blood Albumin Decreased Blood Triglycerides Increased Bronchitis Cholecystectomy Coma Compulsions Constipation Diabetes Mellitus Diabetes Mellitus Non-Insulin-Dependent Diabetic Neuropathy Diarrhoea Dilatation Intrahepatic Duct Acquired Disorientation Drug Withdrawal Syndrome Ear Pain Eating Disorder Electrocardiogram Abnormal Fatigue Gastritis Gastrooesophageal Reflux Disease Hepatic Mass Hepatic Steatosis Herpes Simplex Hydronephrosis Hyperlipidaemia Hypertension Hypoglycaemia Insomnia 24-Jun-2005 12:19 PM Page: 3587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritable Bowel Syndrome Joint Sprain Mania Report Source Product Role Manufacturer Route Dose Duration Meningioma Consumer Zyprexa-Oral Mental Status Changes Health (Olanzapine) Pancreatitis Chronic Professional (Olanzapine) PS 10 MG/1 DAY Pelvic Mass Serzone (Nefazodone Renal Mass Hydrochloride) C Rhinitis Risperdal Skin Papilloma (Risperidone) C Sleep Apnoea Syndrome Depakote (Valproate Upper Respiratory Tract Semisodium) C Infection Hydrochlorothiazide C Weight Increased Levothyroxine C Estradiol C Hydrocodone W/Apap C Cozaar (Losartan Potassium) C Lipitor (Atorvastatin Calcium) C Neurontin (Gabapentin Pfizer) C Amitriptyline C Metoclopramide C Clonidine C Imitrex (Sumatriptan Succinate) C Topamax (Topiramate) C Norvasc (Amlodipine) C Ibuprofen (Ibuprofen) C Nicotrol (Nicotine) C Vioxx (Rofecoxib) C Skelaxin (Metaxalone) C Ultram (Tramadol Hydrochloride) C Zanaflex (Tizanidine Hydrochloride) C Ambien (Zolpidem Tartrate) C Date:04/20/05ISR Number: 4641573-3Report Type:Expedited (15-DaCompany Report #US_0411107616 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Consumer Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 25 MG DAY 870 DAY Loss Of Consciousness Seroquel (Quetiapine Respiratory Arrest Fumarate) C Symbyax C Apo-Divalproex (Valproate Semisodium) C Glucophage (Metformin) C Glyset (Miglitol) C Starlix 24-Jun-2005 12:19 PM Page: 3588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nateglinide) C Actos (Pioglitazone Hydrochloride) C Avandia (Rosiglitazone Maleate) C Zoloft (Sertraline Hydrochloride) C Sonata (Zaleplon) C Miralax (Macrogol) C Tricor (Fenofibrate) C Altace (Ramipril Dura) C Pletal (Cilostazol) C Date:04/20/05ISR Number: 4641574-5Report Type:Expedited (15-DaCompany Report #USA050394498 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Consumer Zyprexa-Oral Eating Disorder (Olanzapine) Transient Ischaemic (Olanzapine) PS Attack Namenda (Memantine Hydrochloride) C Fosamax (Alendronate Sodium) C Lexapro (Escitalopram Oxalate) C Zocor (Simvastatin Ratiopharm) C Glyburide C Furosemide (Furosemide) C Aggrenox C Bextra (Valdecoxib) C Nexium (Esomeprazole Magnesium) C Avandia (Rosiglitazone Maleate) C Clonazepam C Date:04/20/05ISR Number: 4641575-7Report Type:Expedited (15-DaCompany Report #US_0411108209 Age:40 YR Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Anaemia Other Anorexia Bronchitis Bulimia Nervosa Coma Diabetes Mellitus Non-Insulin-Dependent Drug Abuser Drug Withdrawal Syndrome Dysphoria Ear Pain Eating Disorder 24-Jun-2005 12:19 PM Page: 3589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Fibromyalgia Gastritis Report Source Product Role Manufacturer Route Dose Duration Gastrooesophageal Reflux Consumer Zyprexa-Oral Disease Health (Olanzapine) Hepatic Enzyme Increased Professional (Olanzapine) PS 10 MG/1 DAY Hepatic Mass Serzone (Nefazodone Hepatic Steatosis Hydrochloride) C Herpes Simplex Risperdal Hypercholesterolaemia (Risperidone) C Hyperlipidaemia Depakote (Valproate Hypertension Semisodium) C Hypoglycaemia Hydrochlorothiazide C Insomnia Levothyroxine C Irritable Bowel Syndrome Estradiol C Joint Sprain Hydrocodone W/Apap C Loss Of Consciousness Cozaar (Losartan Mania Potassium) C Meningioma Benign Lipitor Mental Status Changes (Atorvastatin Nasopharyngitis Calcium) C Nephrolithiasis Neurontin Obesity (Gabapentin Pfizer) C Obsessive-Compulsive Amitriptyline C Disorder Metoclopramide C Pancreatitis Chronic Clonidine C Rhinitis Imitrex (Sumatriptan Sinusitis Succinate) C Skin Papilloma Topamax (Topiramate) C Sleep Apnoea Syndrome Norvasc (Amlodipine) C Upper Respiratory Tract Ibuprofen Infection (Ibuprofen) C Vision Blurred Nicotrol (Nicotine) C Vioxx (Rofecoxib) C Skelaxin (Metaxalone) C Ultram (Tramadol Hydrochloride) C Zanaflex (Tizanidine Hydrochloride) C Ambien (Zolpidem Tartrate) C Date:04/20/05ISR Number: 4641577-0Report Type:Expedited (15-DaCompany Report #US_0411108016 Age:13 YR Gender:Female I/FU:F Outcome PT Hospitalization - Akathisia Initial or Prolonged Bipolar Disorder Decreased Appetite Depression Diabetes Mellitus Diarrhoea Excoriation Feeling Guilty Hallucination Influenza Like Illness Intentional Self-Injury Iron Deficiency Anaemia Pharyngitis 24-Jun-2005 12:19 PM Page: 3590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Polyuria Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Upper Respiratory Tract Consumer Zyprexa Infection Vision Blurred (Olanzapine) PS ORAL 30 MG AT Weight Increased BEDTIME Lamotrigine C Escitalopram C Ferrour Sulfate (Ferrous Sulfate) C Diphenhydramine C Lithium Carbonate (Lithium Carbonate) C Quetiapine C Risperidone C Abilify (Aripiprazole) C Date:04/20/05ISR Number: 4641582-4Report Type:Expedited (15-DaCompany Report #USA050393219 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia, Paranoid Health Zyprexa Initial or Prolonged Type Professional Treatment Noncompliance (Olanzapine) PS ORAL 30 MG DAY Zyprexa Dispersible (Olanzapine) SS 30 MG DAY Date:04/20/05ISR Number: 4641583-6Report Type:Expedited (15-DaCompany Report #US_0503114238 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Study Olanzapine-Long-Acti Initial or Prolonged Depressed Level Of Health ng Im (Depot) PS INTRAMUSCULAR 300 MG EVERY Other Consciousness Professional OTEHR WEEK Oxygen Saturation Advir C Decreased Diazepam C Respiratory Acidosis Date:04/20/05ISR Number: 4641904-4Report Type:Expedited (15-DaCompany Report #USA050494989 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hallucination Health Symbyax-Olanzapine Hospitalization - Hepatic Failure Professional 6mg / Fluoxetine Initial or Prolonged Company 25mg (Olanzapin PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG Cymbalta (Duloxetine Hydrochloride) SS 60 MG 24-Jun-2005 12:19 PM Page: 3591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4641918-4Report Type:Expedited (15-DaCompany Report #USA050494753 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Metastatic Consumer Zyprexa-Oral Life-Threatening Metastases To Kidney (Olanzapine) Renal Cell Carcinoma (Olanzapine) PS 10 MG DAY Stage Unspecified Lithium C Depakote (Valproate Semisodium) C Vicodin C Date:04/20/05ISR Number: 4641982-2Report Type:Expedited (15-DaCompany Report #US_0411107617 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Zyprexa-Oral Abnormal (Olanzapine) Hypertension (Olanzapine) PS 15 MG Myocardial Infarction Pancreatitis Vision Blurred Date:04/20/05ISR Number: 4641985-8Report Type:Expedited (15-DaCompany Report #US_0411107732 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Consumer Zyprexa-Oral Abnormal (Olanzapine) Diabetes Mellitus (Olanzapine) PS 7.5 MG Hypertension Date:04/20/05ISR Number: 4642066-XReport Type:Expedited (15-DaCompany Report #JP_050406284 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Red Blood Cell Count Foreign Zyprexa-Oral Initial or Prolonged Decreased Health (Olanzapine) White Blood Cell Count Professional (Olanzapine) PS 3 MG DAY Decreased Company Representative Other Date:04/20/05ISR Number: 4642067-1Report Type:Expedited (15-DaCompany Report #GBS050417060 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Olanzapine-Oral Initial or Prolonged Phosphokinase Increased Health (Olanzapine) PS Blood Pressure Abnormal Professional Solian (Amisulpride) C Extrapyramidal Disorder Other Mirtazapine C Hyperhidrosis Citalopram C Malaise Zopiclone Parkinsonism (Zopiclone) C Pyrexia Weight Decreased 24-Jun-2005 12:19 PM Page: 3592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4642069-5Report Type:Expedited (15-DaCompany Report #JP_050406289 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Zyprexa-Oral Initial or Prolonged Decreased Health (Olanzapine) Professional (Olanzapine) PS 2.5 MG DAY Company Fero Gradumet C Representative Marzulene S C Other Glycyron C Total Parenteral Nutrition C Date:04/20/05ISR Number: 4642083-XReport Type:Expedited (15-DaCompany Report #2005052957 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Self-Medication Health Geodon (Ziprasidone) PS Professional Bupropion Company Hydrochloride Representative (Bupropion Hydrochloride) SS Olanzapine/Fluoxetin e Hydrochloride (Fluoxetine Hydrochloride, Olanzapine) SS Mirtazapine (Mirtazapine) SS Obetrol (Amfetamine Aspartate, Amfetamine Sulfate, Dexamethaosne Saccharate, SS Date:04/20/05ISR Number: 4642259-1Report Type:Expedited (15-DaCompany Report #USA050290523 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Zyprexa-Oral Hospitalization - Pulmonary Embolism Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS 10 MG Representative Zyprexa-Rapid-Acting Im (Olanzapine) SS Date:04/20/05ISR Number: 4642260-8Report Type:Expedited (15-DaCompany Report #USA050393602 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Zyprexa-Oral Initial or Prolonged (Olanzapine) Other (Olanzapine) PS 10 MG/1 DAY 24-Jun-2005 12:19 PM Page: 3593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4642261-XReport Type:Expedited (15-DaCompany Report #US_0406103675 Age:49 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acne Initial or Prolonged Alanine Aminotransferase Other Increased Ammonia Increased Amnesia Anger Anxiety Apathy Aspartate Aminotransferase Increased Bacterial Infection Blood Albumin Decreased Blood Glucose Increased Blood Thyroid Stimulating Hormone Decreased Contusion Cystitis Depressed Mood Depression Diabetes Mellitus Non-Insulin-Dependent Difficulty In Walking Disturbance In Attention Diverticulitis Dizziness Drug Abuser Eye Disorder Fall Fatigue Fear Flat Affect Formication Gamma-Glutamyltransferase Increased Hallucination, Auditory Headache Hypercholesterolaemia Hyperphagia Hypotension Klebsiella Infection Loss Of Consciousness Muscle Spasms Muscle Twitching Nightmare Panic Disorder Polysubstance Abuse Prescribed Overdose Self Mutilation Sexual Assault Victim Sleep Disorder Suicidal Ideation Syncope Thinking Abnormal Treatment Noncompliance Tremor Urinary Tract Infection Vitamin B12 Decreased 24-Jun-2005 12:19 PM Page: 3594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vulvovaginal Discomfort Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 45 MG AT BEDTIME Abilify (Aripiprazole) C Wellbutrin Sr (Bupropion Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Antabuse (Disulfiram) C Spironolactone (Spironolactone) C Lithium Carbonate C Lisonopril (Lisinopril) C Atorvastatin C Metformin C Risperdal (Risperidone) C Vitamin B12 C Zantac (Ranitidine Hydrochloride) C Bactrinm Ds C Erythromycin (Erythromycin) C Vistaril (Hydroxyaine Embonate) C Tetracycline C Clonidine C Nicotine Dermal Patch (Nicotine Resin) C Thiamine C Multivitamin C Mylanta C Milk Of Magnesia C Cleocin T (Clindamycin Phosphate) C Artane (Trihexyphenidyl Hydrochloride) C Dulcolax (Bisacodyl) C Diphenhydramine C Neomycin C Levaquin (Levofloxacin) C 24-Jun-2005 12:19 PM Page: 3595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4642330-4Report Type:Expedited (15-DaCompany Report #CA_050407962 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Humulin-Human Pancreatitis Consumer Insulin PS Other Olanzapine (Olanzapine) SS ORAL 7.5 MG DAY Codeine C Insulin C Lipitor (Atorvastatin Calcium) C Metformin C Date:04/20/05ISR Number: 4642782-XReport Type:Expedited (15-DaCompany Report #GBS050417050 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Olanzapine-Oral Attack Health (Olanzapine) PS Professional Risperidone C Other Date:04/20/05ISR Number: 4642789-2Report Type:Expedited (15-DaCompany Report #AU_050408492 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Zyprexa-Oral Initial or Prolonged Pregnancy Health (Olanzapine) Intentional Misuse Professional (Olanzapine) PS 2.5 MG DAY Mental Disorder Company Zofran (Ondansetron Off Label Use Representative Hydrochloride) C Other Avanza (Mirtazapine Orifarm) C Date:04/20/05ISR Number: 4642791-0Report Type:Expedited (15-DaCompany Report #FR_050406185 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Zyprexa-Oral Initial or Prolonged Positive Health (Olanzapine) Diabetic Ketoacidosis Professional (Olanzapine) PS 15 MG DAY Hepatic Steatosis Other Depakote (Valproate Hepatocellular Damage Semisodium) C Hiatus Hernia Date:04/20/05ISR Number: 4642853-8Report Type:Expedited (15-DaCompany Report #EWC050142117 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Foreign Zyprexa-Oral Pituitary Cyst Health (Olanzapine) Treatment Noncompliance Professional (Olanzapine) PS 10 MG DAY Other Zyprexa - Rapid- Acting Im (Olanzapine) SS 10 MG DAY 24-Jun-2005 12:19 PM Page: 3596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4642855-1Report Type:Expedited (15-DaCompany Report #FR_050305998 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zyprexa-Oral Initial or Prolonged Corrected Interval Health (Olanzapine) Prolonged Professional (Olanzapine) PS 20 MG DAY Electrocardiogram Qt Company Stilnox (Zolpidem Prolonged Representative Tartrate) C Other Date:04/20/05ISR Number: 4642858-7Report Type:Expedited (15-DaCompany Report #DE_050215232 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activated Partial Foreign Zyprexa-Oral Thromboplastin Time Health (Olanzapine) Prolonged Professional (Olanzapine) PS 5 MG DAY Prothrombin Time Other Fluoxetine Prolonged (Fluoxetine0 C Voltaren (Diclofenac Potassium) C Date:04/20/05ISR Number: 4642865-4Report Type:Expedited (15-DaCompany Report #EWC050342999 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Rigidity Foreign Zyprexa-Oral Hospitalization - Blood Thyroid Stimulating Health (Olanzapine) Initial or Prolonged Hormone Increased Professional (Olanzapine) PS 30 MG DAY Other Colitis Ischaemic Company Topiramate C Condition Aggravated Representative Heparin C Hepatic Lesion Other Aripiprazole C Hepatotoxicity Hypothyroidism Intestinal Dilatation Intestinal Hypomotility Necrosis Ischaemic Psychotic Disorder Pulmonary Haemorrhage Renal Failure Shock Date:04/20/05ISR Number: 4642866-6Report Type:Expedited (15-DaCompany Report #EWC050343095 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Zyprexa-Oral Dizziness Health (Olanzapine) Hypotension Professional (Olanzapine) PS 10 MG/1 DAY Ventricular Extrasystoles Other Date:04/20/05ISR Number: 4642867-8Report Type:Expedited (15-DaCompany Report #DE_050315454 Age:49 YR Gender:Female I/FU:F Outcome PT Other Aspartate Aminotransferase 24-Jun-2005 12:19 PM Page: 3597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Other Lorazepam C Quilonum- Slow Release (Lithium Carbonate) C Date:04/20/05ISR Number: 4642877-0Report Type:Expedited (15-DaCompany Report #GBS050316850 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Olanzapine-Oral Choking Health (Olanzapine) PS 20 MG DAY Emotional Disorder Professional Quetiapine C Injury Asphyxiation Other Diazepam C Date:04/20/05ISR Number: 4642879-4Report Type:Expedited (15-DaCompany Report #EWC050343070 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Zyprexa-Oral Increased Health (Olanzapine) Increased Appetite Professional (Olanzapine) PS 5 MG Metabolic Syndrome Other Fluctin-Oral Weight Increased (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG Date:04/20/05ISR Number: 4642882-4Report Type:Expedited (15-DaCompany Report #JP_050105711 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Foreign Zyprexa-Oral Other Blood Creatine Health (Olanzapine) Phosphokinase Increased Professional (Olanzapine) PS 20 MG DAY Blood Lactate Company Risperdal Dehydrogenase Increased Representative (Risperidone) C Blood Potassium Increased Other Biperiden C Blood Sodium Decreased Chlorpromazine C Cardio-Respiratory Arrest Flunitrazepam C Dehydration Fluphenazine Delusion Decanoate C Diabetic Coma Haemoglobin Decreased Ketosis Lymphadenopathy Nasopharyngitis Pharyngeal Erythema Red Blood Cell Count Decreased Tenderness White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 3598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4642884-8Report Type:Expedited (15-DaCompany Report #JP_050306088 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Zyprexa-Oral Initial or Prolonged Dysuria Health (Olanzapine) Hepatic Function Abnormal Professional (Olanzapine) PS 15 MG DAY Neuroleptic Malignant Company Zotepine C Syndrome Representative Biperiden Psychiatric Symptom Other Hydrochloride C Serotonin Syndrome Flunitrazepam C Tachycardia White Blood Cell Count Increased Date:04/20/05ISR Number: 4642890-3Report Type:Expedited (15-DaCompany Report #FR_050306094 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Rapid Acting Coma Health Im (Olanzapine) PS 10 MG DAY Lung Infection Professional Rivotril Mendelson'S Syndrome Other (Clonazepam) C Sepsis Status Epilepticus Treatment Noncompliance Date:04/20/05ISR Number: 4643417-2Report Type:Direct Company Report #CTU 246663 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Zyprexa 5 Mg Bid PS ORAL 5 MG BID PO Initial or Prolonged Inadequate Control Diabetes Mellitus Non-Insulin-Dependent Date:04/21/05ISR Number: 4641503-4Report Type:Expedited (15-DaCompany Report #GBWYE514718MAR05 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lithium PS Glaxosmithkline UNKNOWN 600MG Per day Initial or Prolonged Alanine Aminotransferase Efexor Xl SS UNKNOWN Increased Mirtazapine SS UNKNOWN 60MG Unknown Blood Alkaline Olanzapine SS UNKNOWN 102 WK Phosphatase Increased Efexor C 37.5MG Per Gamma-Glutamyltransferase day Abnormal Intestinal Obstruction Liver Function Test Abnormal Transaminases Increased Date:04/21/05ISR Number: 4641618-0Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0297123-00 Age:25 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Bilirubin Increased Initial or Prolonged Diabetic Ketoacidosis 24-Jun-2005 12:19 PM Page: 3599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Steatosis Hepatocellular Damage Hiatus Hernia Report Source Product Role Manufacturer Route Dose Duration Mallory-Weiss Syndrome Depakote Tablets PS ORAL 285 DAY Olanzapine SS ORAL 287 DAY Lithium Carbonate C Amisulpride C Date:04/21/05ISR Number: 4641989-5Report Type:Expedited (15-DaCompany Report #USA050494681 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Replacement Health Zyprexa Initial or Prolonged Extrapyramidal Disorder Professional (Olanzapine) PS ORAL 20 MG DAY Other Company Celexa Representative (Citalopram Hydrobromide) C Prevacid (Lansoprazole) C Date:04/21/05ISR Number: 4641998-6Report Type:Expedited (15-DaCompany Report #USA040874404 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Consumer Zyprexa PS ORAL 2.5 MG/2 DAY Hospitalization - Cardiac Failure Asa (Acetylsalicylic Initial or Prolonged Congestive Acid) C Other Cerebrovascular Accident Fall Hip Fracture Intestinal Perforation Pulmonary Thrombosis Sepsis Date:04/21/05ISR Number: 4642025-7Report Type:Expedited (15-DaCompany Report #US_0503114606 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Study Olanzapine-Long-Acti Initial or Prolonged Drug Ineffective Health ng Im (Depot) PS 210 MG Hallucinations, Mixed Professional Hostility Overdose Paranoia Schizophrenia, Undifferentiated Type Date:04/21/05ISR Number: 4642047-6Report Type:Expedited (15-DaCompany Report #JP_050406301 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Delusion Initial or Prolonged Dyskinesia Dysphonia Dystonia Hallucination, Auditory Psychomotor Hyperactivity 24-Jun-2005 12:19 PM Page: 3600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salivary Hypersecretion Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa Literature (Olanzapine) PS ORAL 25 MG DAY Health Risperidone C Professional Quetiapine C Other Date:04/21/05ISR Number: 4642048-8Report Type:Expedited (15-DaCompany Report #GBS050417071 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Valve Disease Foreign Olanzapine PS ORAL 20 MG DAY Heart Rate Increased Health Lustral Hypotension Professional (Sertraline Lethargy Other Hydrochloride) C Loss Of Consciousness Somnolence Date:04/21/05ISR Number: 4643371-3Report Type:Expedited (15-DaCompany Report #2004029509 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zoloft (Sertraline) PS ORAL 100 MG (100 Other Drug Interaction Professional MG, 1 IN 1 Drug Toxicity D), ORAL Vomiting Olanzapine (Olanzapine) SS ORAL 20 MG (5 MG, 1 IN 1 D), ORAL Valproate Semisodium (Valproate Semisodium) SS ORAL 1000 MG (500 MG, 2 IN 1 D), ORAL Quetiapine (Quetiapine) SS 400 MG (1 IN 1 D) Date:04/22/05ISR Number: 4642657-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041202809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Risperdal PS OROPHARINGEAL Other Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Olanzapine SS 8 DAY Chlorpromazine C Date:04/22/05ISR Number: 4646180-4Report Type:Direct Company Report #CTU 246967 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Tramadol 100 Mg Initial or Prolonged Ortho-Mcneal PS Ortho-Mcneal ORAL 100 MG BID ORAL 24-Jun-2005 12:19 PM Page: 3601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa 5 Mg Lilly SS Lilly ORAL 5 MG AT BEDTIME ORAL Prozac C Date:04/25/05ISR Number: 4645753-2Report Type:Expedited (15-DaCompany Report #2005059495 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Increased Foreign Lustral (Sertraline) PS ORAL 100 MG (100 Heart Valve Insufficiency Health MG, 1 IN 1 Hypotension Professional D), ORAL 2 YR Lethargy Olanzapine Loss Of Consciousness (Olanzapine) SS 20 MG (20 MG, Somnolence 1 IN 1 D) Date:04/25/05ISR Number: 4646074-4Report Type:Expedited (15-DaCompany Report #2005058601 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Rash Generalised Health Azithromycin Intervention to Professional (Azithromycin) PS ORAL ORAL Prevent Permanent Company Lamotrigine Impairment/Damage Representative (Lamotrigine) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL (10 MG), ORAL Date:04/25/05ISR Number: 4646695-9Report Type:Expedited (15-DaCompany Report #05P-056-0297123-00 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Depakote Tablets Initial or Prolonged Diabetic Ketoacidosis Health (Depakote) Hepatic Steatosis Professional (Divalproex Sodium) Hepatocellular Damage (Divalproex Sodium) PS ORAL 1000 MG, 1 IN Hiatus Hernia 1 D, ORAL Mallory-Weiss Syndrome Olanzapine SS ORAL 15 MG, 1 IN 1 D, ORAL Lithium Carbonate C Amisulpride C Date:04/26/05ISR Number: 4645134-1Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050403843 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Olanzapine SS OROPHARINGEAL Date:04/26/05ISR Number: 4647462-2Report Type:Expedited (15-DaCompany Report #CA_050407962 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Humulin-Human Convulsion Consumer Insulin (Rdna) Pancreatitis Other Unknown Formulation 24-Jun-2005 12:19 PM Page: 3602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Hu PS Olazapine-Oral (Olanzapine) SS 7.5 MG DAY Codeine C Insulin C Lipitor (Atorvastatin Calcium) C Metformin C Date:04/26/05ISR Number: 4647465-8Report Type:Expedited (15-DaCompany Report #AU_050408485 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphocyte Count Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 5 MG/TWICE Neutropenia Professional DAY White Blood Cell Count Company Olanzapine-Dispersib Decreased Representative le (Olanzapine) SS 5 MG/TWICE Other DAY Clopixol (Zuclopenthixol) C Date:04/26/05ISR Number: 4647602-5Report Type:Expedited (15-DaCompany Report #2005059014 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Atarax (Tablet) Initial or Prolonged Drug Abuser Health (Hydroxyzine Drug Dependence Professional Hydrochloride) PS Drug Screen Positive Cyamemazine Opiates Positive (Cyamemazine) SS ORAL ORAL Olanzapine (Olanzapine) SS Diazepam (Diazepam) SS Desloratadine (Desloratadine) SS ORAL ORAL All Other Therapeutic Products (All Other Therapeutics Products) C Date:04/26/05ISR Number: 4647701-8Report Type:Expedited (15-DaCompany Report #USA050494989 Age:33 YR Gender:Female I/FU:F Outcome PT Death Abnormal Behaviour Hospitalization - Agitation Initial or Prolonged Coma Other Condition Aggravated Ear Pain Fatigue Gastrointestinal Haemorrhage Hallucination Hepatic Failure Hypoaesthesia Influenza Like Illness 24-Jun-2005 12:19 PM Page: 3603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Overdose Productive Cough Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Symbyax-Olanzapine Suicidal Ideation Professional 6mg / Fluoxetine Weight Decreased Company 25mg (Olanzapin PS Representative Zyprexa-Oral (Olanzapine) (Olanzapine) SS 2.5 MG Cymbalta (Duloxetine Hydrochloride) SS 60 MG/1 DAY Synthroid (Levothyroxine Sodium) C Macrobid (Nitrofurantoin) C Xanax (Alprazolam Dum) C Tamiflu (Oseltamivir Phosphate) C Levaquin (Levoloxacin) C Zyrtec (Cetirizine Hydrochloride) C Flonase (Fluticasone Propionate) C Tylenol Pm C Date:04/26/05ISR Number: 4647704-3Report Type:Expedited (15-DaCompany Report #US_0411107568 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biliary Tract Disorder Consumer Zyprexa-Oral Blood Cholesterol (Olanzapine) Abnormal (Olanzapine) PS 15 MG Blood Triglycerides Increased Diabetes Mellitus Hyperphagia Hypertension Myocardial Ischaemia Obesity Vision Blurred Date:04/27/05ISR Number: 4646261-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-402844 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Xenical PS Roche ORAL Drug Interaction Acamprosate C Psychotic Disorder Disulfiram C Schizoaffective Disorder Zopiclone C ONE AT NIGHT. Thiamine C Trazodone C Vitamin B Complex C Epilim Chrono C ONE IN THE MORNING, TWO ON UNSPECIFIED 24-Jun-2005 12:19 PM Page: 3604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TIME. Amisulpride I UNKNOWN Olanzapine I UNKNOWN ONE EVERY NIGHT. Date:04/27/05ISR Number: 4648314-4Report Type:Expedited (15-DaCompany Report #FR_050406229 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS 20 MG/L DAY Other Date:04/27/05ISR Number: 4648315-6Report Type:Expedited (15-DaCompany Report #GBS050417087 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Zyprexa-Oral Decreased Health (Olanzapine) White Blood Cell Count Professional (Olanzapine) PS 15 MG DAY Decreased Company Sulpiride C Representative Procyclidine C Other Date:04/27/05ISR Number: 4648316-8Report Type:Expedited (15-DaCompany Report #GBS050417137 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Date:04/27/05ISR Number: 4648317-XReport Type:Expedited (15-DaCompany Report #FR_050406202 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Zyprexa-Oral Initial or Prolonged Delusion Health (Olanzapine) Hallucination Professional (Olanzapine) PS 5 MG DAY Other Rosuvastatin Calcium C Date:04/27/05ISR Number: 4648318-1Report Type:Expedited (15-DaCompany Report #GBS050417153 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Other Drug Level Increased Health (Olanzapine) PS 7.5 MG DAY Injury Asphyxiation Professional Venlafaxine C Company Representative Other 24-Jun-2005 12:19 PM Page: 3605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/05ISR Number: 4648345-4Report Type:Expedited (15-DaCompany Report #EWC050443503 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Increased Foreign Olanzapine-Oral Initial or Prolonged Drug Withdrawal Syndrome Health (Olanzapine) PS 5 MG DAY Inflammation Professional Nexium (Esomeprazole Neuroleptic Malignant Other Magnesium) C Syndrome Tramal (Tramadol Prostatitis Hydrochloride) C Psychotic Disorder Temesta (Lorazepam) C Rebound Effect Fraxiparine (Nadroparin Calcium) C Date:04/27/05ISR Number: 4648363-6Report Type:Expedited (15-DaCompany Report #EWC050342956 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Olanzapine-Oral Increased Study (Olanzapine) PS Aspartate Health Aminotransferase Professional Increased Other Blood Cholesterol Increased Blood Lactate Dehydrogenase Increased Eosinophil Count Increased Date:04/27/05ISR Number: 4648374-0Report Type:Expedited (15-DaCompany Report #JP_050406343 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Foreign Zyprexa-Oral Genital Haemorrhage Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Rohypnol Representative (Flunitrazepam Eg) C Other Furosemide (Furosemide) C Depakene (Valproate Sodium) C Date:04/27/05ISR Number: 4648375-2Report Type:Expedited (15-DaCompany Report #JP_050306162 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Foreign Zyprexa-Oral Abnormal Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Valproate Sodium C Representative Fluvoxamine Maleate C Other 24-Jun-2005 12:19 PM Page: 3606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/05ISR Number: 4648376-4Report Type:Expedited (15-DaCompany Report #JP_050306176 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Permax (Pergolide Initial or Prolonged Hallucination Health Mesylate) PS 1500 UG DAY Parkinsonism Professional Zyprexa-Oral Company (Olanzapine) Representative (Olanzapine) SS 2.5 MG DAY Other Menesit C Solanax (Alprazolam Dum) C Rivotril (Clonazepam) C Date:04/27/05ISR Number: 4648412-5Report Type:Expedited (15-DaCompany Report #EWC050342916 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Foreign Zyprexa-Oral Initial or Prolonged Central-Alveolar Health (Olanzapine) Hypoventilation Professional (Olanzapine) PS 20 MG/1 DAY Chronic Respiratory Company Failure Representative Computerised Tomogram Other Abnormal Extrapyramidal Disorder Pneumonia Date:04/27/05ISR Number: 4648414-9Report Type:Expedited (15-DaCompany Report #JP_050306088 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Zyprexa-Oral Initial or Prolonged Coordination Abnormal Health (Olanzapine) Depressed Level Of Professional (Olanzapine) PS 15 MG DAY Consciousness Company Zotepine C Dysuria Representative Biperiden Hepatic Function Abnormal Other Hydrochloride C Hyperreflexia Flunitrazepam C Neuroleptic Malignant Syndrome Psychiatric Symptom Serotonin Syndrome Tachycardia Date:04/27/05ISR Number: 4648416-2Report Type:Expedited (15-DaCompany Report #GBS050417071 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Valve Disease Foreign Olanzapine-Oral Heart Rate Increased Health (Olanzapine) PS 20 MG DAY Hypotension Professional Lustral (Sertraline Lethargy Other Hydrochloride) C Loss Of Consciousness Somnolence 24-Jun-2005 12:19 PM Page: 3607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/05ISR Number: 4648444-7Report Type:Expedited (15-DaCompany Report #DE_050215277 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Granulocyte Count Foreign Zyprexa-Oral Decreased Health (Olanzapine) Influenza Like Illness Professional (Olanzapine) PS 10 MG DAY Lymphocyte Count Other Increased Platelet Count Decreased White Blood Cell Count Decreased Date:04/27/05ISR Number: 4648446-0Report Type:Expedited (15-DaCompany Report #DE_041114658 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Zyprexa-Oral Bradycardia Health (Olanzapine) Dyspnoea Professional (Olanzapine) PS 15 MG DAY Refusal Of Treatment By Other L-Thyroxin Patient (Levothyroxine Sodium) C Date:04/27/05ISR Number: 4648455-1Report Type:Expedited (15-DaCompany Report #JP_050105573 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Zyprexa-Oral Hospitalization - Choking Study (Olanzapine) Initial or Prolonged Fall Health (Olanzapine) PS 5 MG/L DAY Pleurisy Professional Risperdal Restlessness Other (Risperdone) C Akineton (Biperiden Lactate) C Depakene (Valproate Sodium) C Doral (Quazepam) C Desyrel (Trazodone Hydrochloride) C Biasan C Pentona (Mazaticol Hydrochloride) C Hangekoubokutou C Date:04/27/05ISR Number: 4648510-6Report Type:Expedited (15-DaCompany Report #8009200 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catheter Related Foreign Keppra PS ORAL 1500 MG /D PO Hospitalization - Complication Health Keppra SS ORAL 140000 MG Initial or Prolonged Coma Professional ONCE PO Haemodialysis Other Zyprexa SS ORAL 10 MG /D PO Hypotension Zyprexa SS ORAL 500 MG ONCE Intentional Misuse PO Overdose Diazepam SS ORAL ONCE PO Somnolence Lamictal SS ORAL 600 MG /D PO Suicide Attempt Tachycardia 24-Jun-2005 12:19 PM Page: 3608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/05ISR Number: 4648807-XReport Type:Expedited (15-DaCompany Report #USA050495003 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Urine Present Consumer Zyprexa-Oral Metrorrhagia Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Date:04/27/05ISR Number: 4648935-9Report Type:Expedited (15-DaCompany Report #USA041184844 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Abnormal Consumer Zyprexa-Oral Breast Cancer Stage Ii (Olanzapine) Oestrogen Receptor Assay (Olanzapine) PS 5 MG/1 DAY Positive Zocor (Simvastatin Ratiopharm) C Aricept (Donepezil Hydrochloride) C Date:04/27/05ISR Number: 4648936-0Report Type:Expedited (15-DaCompany Report #US_0407104133 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zyprexa-Oral Initial or Prolonged Atrioventricular Block (Olanzapine) Other First Degree (Olanzapine) PS 20 MG Blood Glucose Increased Paxil (Paroxetine Cardiac Disorder Hydrochloride) C Chest Pain Glucophage Diabetes Mellitus (Metformin) C Diabetic Complication Hyzaar C Emotional Distress Albuterol C Hepatic Enzyme Abnormal Flovent (Fluticasone Hepatitis Propionate) C Hypertension Vioxx (Rofecoxib) C Memory Impairment Zanaflex (Tizanidine Pain Hydrochloride) C Pain In Extremity Neurontin Screaming (Gabapentin Pfizer) C Weight Increased Norvasc (Amlodipine) C Buspirone C Diphenhydramine C Nifedipine C Enalapril Maleate C Serevent Diskus (Salmeterol Xinafoate) C Celebrex (Celecoxib) C Cyclobenzaprine C Lansoprazole C Hydrochlorothiazide C Furosemide (Furosemide) C Lovenox (Heparin-Fraction, Sodium Salt) C 24-Jun-2005 12:19 PM Page: 3609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/05ISR Number: 4648937-2Report Type:Expedited (15-DaCompany Report #US_0501109957 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Consumer Zyprexa-Oral Initial or Prolonged Living Impaired (Olanzapine) Other Alcohol Withdrawal (Olanzapine) PS Syndrome Paxil (Paroxetine Anion Gap Increased Hydrochloride) C Anxiety Neurontin Blood Glucose Increased (Gabapentin) C Cellulitis Methadone C Depression Vitamins Nos C Hand Fracture Protonix Liver Disorder (Pantoprazole) C Neuropathy Pancreatitis Panic Attack Personality Disorder Platelet Count Decreased Polysubstance Dependence Road Traffic Accident Toxicologic Test Abnormal White Blood Cell Count Increased Date:04/27/05ISR Number: 4648982-7Report Type:Expedited (15-DaCompany Report #USA050495438 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Symbyax-Olanzapine / Professional Fluoxetine (Unknown Company Dose) (Ola PS Representative Date:04/27/05ISR Number: 4649712-5Report Type:Expedited (15-DaCompany Report #USA050495265 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Consumer Zyprexa-Oral Hospitalization - Pancreatitis (Olanzapine) Initial or Prolonged Pneumonia (Olanzapine) PS Other Date:04/27/05ISR Number: 4649713-7Report Type:Expedited (15-DaCompany Report #US_0411107538 Age:51 YR Gender:Female I/FU:I Outcome PT Blood Cholesterol Increased Blood Glucose Increased Cough Decreased Appetite Diabetic Neuropathy Haemoptysis Haemorrhoidal Haemorrhage Mood Swings Sedation Treatment Noncompliance 24-Jun-2005 12:19 PM Page: 3610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 30 MG Sympyax C Glimeperide/Metformi n C Lamictal (Lamotrigine) C Lorazepam C Benztropine C Lithium Carbonate (Lithium Carbonate) C Divalproex Sodium C Trazadone (Trazodone) C Escitalopram C Tiagabine C Loxapine C Date:04/28/05ISR Number: 4649412-1Report Type:Direct Company Report #CTU 247346E Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Symbyax PS FEW DOSES Increased ONLY Hepatic Enzyme Abnormal Date:04/29/05ISR Number: 4649132-3Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0379341A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Augmentin Iv PS Glaxosmithkline INTRAVENOUS 3G Per day 10 DAY Initial or Prolonged Increased Zyprexa SS ORAL 1UNIT Per day Aspartate Tranxene 50 SS ORAL 25MG Twice Aminotransferase per day Increased Anafranil SS ORAL 75MG Per day Blood Alkaline Oflocet SS INTRAVENOUS 2G Per day 10 DAY Phosphatase Increased Vasten SS ORAL 40MG Per day Gamma-Glutamyltransferase Vastarel C UNKNOWN 35MG Twice Increased per day Nitriderm C Glaxosmithkline UNKNOWN Seresta C UNKNOWN 50MG Per day Tercian C UNKNOWN 25MG Twice per day Kardegic C UNKNOWN 75MG Per day Date:04/29/05ISR Number: 4650618-6Report Type:Expedited (15-DaCompany Report #US_0411108209 Age:40 YR Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Anaemia Other Asthenia Blood Cholesterol Increased 24-Jun-2005 12:19 PM Page: 3611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Glucose Increased Bronchitis Cholelithiasis Report Source Product Role Manufacturer Route Dose Duration Coma Consumer Zyprexa-Oral Compulsions Health (Olanzapine) Constipation Professional (Olanzapine) PS 10 MG/1 DAY Diabetes Mellitus Serzone (Nefazodone Non-Insulin-Dependent Hydrochloride) C Diabetic Neuropathy Risperdal Diarrhoea (Risperidone) C Drug Withdrawal Syndrome Depakote (Valproate Ear Pain Semisodium) C Eating Disorder Hydrochlorothiazide C Electrocardiogram Levothyroxine C Abnormal Estradiol C Fibromyalgia Hydrocodone W/Apap C Gastritis Cozaar (Losartan Gastrooesophageal Reflux Potassium) C Disease Lipitor Hepatic Neoplasm (Atorvastatin Hepatic Steatosis Calcium) C Herpes Virus Infection Neurontin Hypercholesterolaemia (Gabapentin Pfizer) C Hyperlipidaemia Amitriptyline C Hypertension Metoclopramide C Hypoglycaemia Clonidine C Insomnia Imitrex (Sumatriptan Irritable Bowel Syndrome Succinate) C Joint Injury Topamax (Topiramate) C Joint Sprain Norvasc (Amlodipine) C Loss Of Consciousness Ibuprofen Mania (Ibuprofen) C Meningioma Nicotrol (Nicotine) C Mental Status Changes Vioxx (Rofecoxib) C Nasopharyngitis Skelaxin Nephrolithiasis (Metaxalone) C Obesity Ultram (Tramadol Pain In Extremity Hydrochloride) C Pancreatitis Zanaflex (Tizanidine Pancreatitis Chronic Hydrochloride) C Perforated Ulcer Ambien (Zolpidem Rhinitis Tartrate) C Sinusitis Skin Papilloma Sleep Apnoea Syndrome Upper Respiratory Tract Infection Vision Blurred Date:04/29/05ISR Number: 4650622-8Report Type:Expedited (15-DaCompany Report #US_0412108775 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholecystitis Infective Consumer Zyprexa-Oral Life-Threatening Diabetes Mellitus (Olanzapine) Hospitalization - Pancreatitis (Olanzapine) PS 12.5 MG Initial or Prolonged Other 24-Jun-2005 12:19 PM Page: 3612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/05ISR Number: 4650858-6Report Type:Direct Company Report #CTU 247413 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Zyprexa PS Medication Error Zetia SS Date:05/02/05ISR Number: 4651984-8Report Type:Direct Company Report #CTU 247482 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Zyprexa PS Syndrome Date:05/02/05ISR Number: 4651997-6Report Type:Expedited (15-DaCompany Report #2005-126842-NL Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Literature Mirtazapine PS 60 MG QD Other Consciousness Health Olanzapine SS 10 MG QD Medication Error Professional Clonazepam SS 0.25 MG BID Buspirone C 45 MG BID Date:05/02/05ISR Number: 4652381-1Report Type:Direct Company Report #CTU 247546 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypotension Olanzapine Im Intervention to Lethargy 5mg/Ml Lilly PS Lilly INTRAMUSCULAR 10MG ONE Prevent Permanent DOSE Impairment/Damage INTRAMUSCU Lorazepam Im 2mg/Ml SS INTRAMUSCULAR 2MG ONE DOSE INTRAMUSCU Date:05/03/05ISR Number: 4651371-2Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0277713-00 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Epival PS ORAL Chest Discomfort Epival SS Lobar Pneumonia Epival SS Olanzapine SS ORAL Olanzapine SS Olanzapine SS Postmarketed Study Drugs SS Clonazepam C ORAL Omeprazole C Rofecoxib C Zopiclone C ORAL 24-Jun-2005 12:19 PM Page: 3613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4654564-3Report Type:Direct Company Report #CTU 247597 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zyprexia Zydis Initial or Prolonged Phosphokinase Increased 5mg Lilly PS Lilly ORAL 5MG TID Loss Of Consciousness ORAL Mental Status Changes Remeon C Miosis Aaricept C Muscle Rigidity Lisinopril C Pyrexia Lorazepam C Prevacid C Asa C Plavix C Tenormin C Depakote C Risperidol C Date:05/03/05ISR Number: 4654567-9Report Type:Direct Company Report #CTU 247598 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Zyprexa 5 Mg PS ONCE PER HOU Other Diarrhoea Dysphonia Faecal Incontinence Hypersomnia Malnutrition Mental Disorder Off Label Use Oral Intake Reduced Personality Change Skin Disorder Date:05/03/05ISR Number: 4655081-7Report Type:Expedited (15-DaCompany Report #2005AC00647 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Tardive Dyskinesia Health PO Prevent Permanent Professional Seroquel SS ORAL 400 MG DAILY Impairment/Damage Other PO Zyprexa SS Lithium SS Date:05/03/05ISR Number: 4655086-6Report Type:Expedited (15-DaCompany Report #2004UW23847 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Zyprexa SS Date:05/04/05ISR Number: 4654872-6Report Type:Expedited (15-DaCompany Report #EWC050343070 Age:66 YR Gender:Female I/FU:F Outcome PT Other Blood Cholesterol Increased 24-Jun-2005 12:19 PM Page: 3614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Triglycerides Increased Increased Appetite Report Source Product Role Manufacturer Route Dose Duration Metabolic Syndrome Foreign Zyprexa-Oral Weight Increased Health (Olanzapine) Professional (Olanzapine) PS 5 MG Other Fluctin-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS 20 MG Date:05/05/05ISR Number: 4653280-1Report Type:Expedited (15-DaCompany Report #GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-UAge: 06UK Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Combivent Dementia (00015/0191) PS B.I. Pharmaceuticals,Inc. /Ridgefield Budesonide SS RESPIRATORY (INHALATION) Frusemide SS Citalopram SS Risedronate SS Donepezil SS Quinapril SS Otriralolactin SS Prednisolone SS Olanzepine SS Not Rpeorted C Date:05/05/05ISR Number: 4655355-XReport Type:Expedited (15-DaCompany Report #USA050495980 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Zyprexa-Oral Other Congestive (Olanzapine) Pneumonia (Olanzapine) PS 7.5 MG DAY Date:05/05/05ISR Number: 4655371-8Report Type:Expedited (15-DaCompany Report #US_0411107605 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Consumer Zyprexa-Oral Abnormal Health (Olanzapine) Blood Triglycerides Professional (Olanzapine) PS 10 MG AT Increased BEDTIME Diabetes Mellitus Symbyax-Olanzapine / Non-Insulin-Dependent Fluoxetine (Unknown Haematuria Dose) (Ola SS Polytraumatism Bupropion C Urinary Tract Infection Glipizide C Metformin C Allegra-D C Premarin C Nexium (Esomeprazole Magnesium) C Lipitor (Atorvastatn 24-Jun-2005 12:19 PM Page: 3615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium) C Tolterodine L-Tartrate C Vioxx (Rofecoxib) C Multivitamin C Date:05/05/05ISR Number: 4655372-XReport Type:Expedited (15-DaCompany Report #US_0502113289 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Consumer Zyprexa-Oral Initial or Prolonged Intestinal Obstruction Health (Olanzapine) Other Pancreatitis Acute Professional (Olanzapine) PS Refusal Of Treatment By Xanax (Alprazolam Patient Dum) C Paxil (Paroxetine Hydrochloride) C Remeron (Mirtazapine Orifarm) C Date:05/05/05ISR Number: 4655373-1Report Type:Expedited (15-DaCompany Report #US-0411107592 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atelectasis Consumer Zyprexa-Oral Blood Cholesterol Health (Olanzapine) Increased Professional (Olanzapine) PS 20 MG Blood Pressure Systolic Olanzipine/Fluoxetin Increased e Capsule C Bundle Branch Block Artane Cardiac Failure (Trihexyphenidyl Congestive Hydrochloride) C Chest Pain Bupropion C Diabetes Mellitus Haloperidol Non-Insulin-Dependent Decanoate C Ear Pain Vioxx (Rofecoxib) C Hyperventilation Furosemide Hypoxia (Furosemide) C Low Density Lipoprotein Estrogens Conjugated C Increased Mass Oedema Peripheral Pneumonia Stomatitis Venous Insufficiency Weight Increased Date:05/05/05ISR Number: 4655374-3Report Type:Expedited (15-DaCompany Report #US_0504115948 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Literature Zyprexa-Oral Head Injury Health (Olanzapine) Loss Of Consciousness Professional (Olanzapine) PS Medication Error Other 24-Jun-2005 12:19 PM Page: 3616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/05ISR Number: 4655375-5Report Type:Expedited (15-DaCompany Report #US_0504115922 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Literature Zyprexa-Oral Drug Dispensing Error Health (Olanzapine) Hypersomnia Professional (Olanzapine) PS Loss Of Consciousness Other Zyrtec (Cetirizine Malaise Hydrochloride) C Date:05/05/05ISR Number: 4655588-2Report Type:Expedited (15-DaCompany Report #US_0504116050 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa-Oral Other Cardiomegaly Professional (Olanzapine) PS 7.5 MG/2 DAY Hallucination Other Clozapine C Hypothyroidism Date:05/05/05ISR Number: 4655589-4Report Type:Expedited (15-DaCompany Report #US_0503113780 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Consumer Zyprexa-Oral Initial or Prolonged Condition Aggravated Health (Olanzapine) PS 10 MG/1 DAY Other Coronary Artery Disease Professional Symbyax-Olanzapine / Diabetes Mellitus Fluoxetine (Unknown Hyperglycaemic Dose) (Ola SS UNKNOWN UNK Hyperosmolar Nonketotic Neurontin Syndrome (Gabapentin Pfizer) C Myocardial Infarction Remeron (Mirtazapine Orifarm) C Trihexyphenidyl C Hydrocodone W/Apap C Roxicet C Furosemide (Furosemide) C Lanoxin (Digoxin -Sandoz) C Diphenhydramine C Metoprolol C Date:05/05/05ISR Number: 4655590-0Report Type:Expedited (15-DaCompany Report #US_0504115473 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Zyprexa-Oral Initial or Prolonged Medication Error Professional (Olanzapine) PS 10 MG Other Somnolence Zyrtec (Cetirizine Hydrochloride) C Levofloxacin C Galenic /Salbutamol Sulfate/Ipratropium Brom/ C Fexofenadine Hydrochloride C Apo-Prednisone (Prednisone) C Mycelex Troche 24-Jun-2005 12:19 PM Page: 3617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clotrimazole) C Levothyroxine Sodium C Paxil (Paroxetine Hydrochloride) C Nitroglycerin (Glyceryl Trinitrate) C Prevacid (Lansoprazole) C Pravachol (Pravastatin Sodium) C Lisinopril (Lisinopril) C Plavix (Clopidogrel Sulfate) C Atenolol C Date:05/05/05ISR Number: 4655724-8Report Type:Expedited (15-DaCompany Report #FR_050406288 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Myocardial Foreign Zyprexa-Oral Infarction Health (Olanzapine) Professional (Olanzapine) PS UNKNOWN UNK Company Representative Other Date:05/05/05ISR Number: 4655725-XReport Type:Expedited (15-DaCompany Report #FR_050406260 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Other Rivotril (Clonazepam) C Methadone C Solian (Amisulpride) C Subutex (Buprenorphine Hydrochloride) C Valium (Diazepam) C Date:05/05/05ISR Number: 4655726-1Report Type:Expedited (15-DaCompany Report #EWC050443713 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa-Oral International Normalised Health (Olanzapine) Ratio Increased Professional (Olanzapine) PS UNKNOWN UNK Other Sintrom (Acenocoumarol) C Digoxine C Diovan C 24-Jun-2005 12:19 PM Page: 3618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/05ISR Number: 4655727-3Report Type:Expedited (15-DaCompany Report #DE_041014485 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Caesarean Section Foreign Olanzapine-Oral Drug Exposure During Health (Olanzapine) PS 5 MG DAY Pregnancy Professional Solian (Amisulpride) C Premature Labour Other Edronax (Reboxetine) C Uterine Haematoma St John'S Wort C Date:05/05/05ISR Number: 4655728-5Report Type:Expedited (15-DaCompany Report #DE_050415716 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zyprexa-Oral Phosphokinase Increased Health (Olanzapine) Chest Pain Professional (Olanzapine) PS 5 MG DAY Other Codiovan C Trevilor (Venlafaxine Hydrochloride) C Date:05/05/05ISR Number: 4655729-7Report Type:Expedited (15-DaCompany Report #FR_050406286 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Persecutory Delusion Foreign Zyprexa-Oral Initial or Prolonged Physical Assault Health (Olanzapine) Professional (Olanzapine) PS 10 MG DAY Company Rivotril Representative (Clonazepam) C Other Date:05/05/05ISR Number: 4655730-3Report Type:Expedited (15-DaCompany Report #FR_050406293 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Foreign Zyprexa-Oral Hospitalization - Coma Health (Olanzapine) Initial or Prolonged Completed Suicide Professional (Olanzapine) PS OTHER 300 MG/1 Intentional Misuse Company OTHER Multiple Drug Overdose Representative Xanax (Alprazolam Pneumonia Aspiration Other Dum) C Date:05/05/05ISR Number: 4655808-4Report Type:Expedited (15-DaCompany Report #GBS050417154 Age:77 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Alanine Aminotransferase Increased Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Abnormal Intestinal Obstruction Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 3619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Transaminases Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Efexor Xl Other (Venlafaxine Hydrochloride) C Efexor (Venlafaxine) C Lithium C Mirtazapine C Date:05/05/05ISR Number: 4655809-6Report Type:Expedited (15-DaCompany Report #FR_050406291 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Myocardial Foreign Zyprexa-Oral Infarction Health (Olanzapine) Professional (Olanzapine) PS Company Representative Other Date:05/05/05ISR Number: 4655810-2Report Type:Expedited (15-DaCompany Report #GBS050417198 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Date:05/05/05ISR Number: 4655812-6Report Type:Expedited (15-DaCompany Report #JP_050406374 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Foreign Zyprexa-Oral Pregnancy Health (Olanzapine) Ear Malformation Professional (Olanzapine) PS Hypoglycaemia Company Representative Other Date:05/05/05ISR Number: 4655813-8Report Type:Expedited (15-DaCompany Report #AU_050408529 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Zyprexa-Oral Increased Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Other Aropax (Paroxetine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/05ISR Number: 4655816-3Report Type:Expedited (15-DaCompany Report #DE_050415688 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Zyprexa-Oral Initial or Prolonged Dizziness Health (Olanzapine) Other Malaise Professional (Olanzapine) PS 10 MG IN THE Ventricular Tachycardia Other EVENING Cipramil (Citalopram Hydrobromide) C Dytide H C Metohexal (Metoprolol Tartrate) C Date:05/05/05ISR Number: 4655818-7Report Type:Expedited (15-DaCompany Report #CA_050408049 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericardial Effusion Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG Company Clomipramine C Representative Lipitor Other (Atorvastatin Calcium) C Capoten (Captopril Biochemie) C Date:05/05/05ISR Number: 4655820-5Report Type:Expedited (15-DaCompany Report #DE_050415705 Age:8 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS Premature Baby Other Solian (Amisulpride) C Edronax (Reboxetine) C St. John'S Wort C Date:05/05/05ISR Number: 4655952-1Report Type:Expedited (15-DaCompany Report #2004100041 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Xanax Tablet Initial or Prolonged Depressed Level Of Health (Alprazolam) PS ORAL ORAL Consciousness Professional Donepezil Feeding Disorder Hydrochloride Hyponatraemia (Donepezil Muscle Rigidity Hydrochloride) SS ORAL ORAL Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL ORAL Paroxetine Hydrochloride (Paroxetine Hydrochloride) SS ORAL 200 MG, ORAL Olanzapine 24-Jun-2005 12:19 PM Page: 3621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS ORAL ORAL Prinizide (Hydrochlorothiazide , Lisinopril) C Pantoprazole (Pantoprazole) C Date:05/05/05ISR Number: 4656365-9Report Type:Expedited (15-DaCompany Report #EWC050443696 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Zyprexa-Rapid-Acting Other Dysphagia Health Im (Olanzapine) PS 10 MG/1 Syncope Professional Clopixol Acuphase Company (Zuclopenthixol Representative Acetate) C Other Clopixol Depot (Zuclopenthixol Decanoate) C Mirtazapine C Diazepam C Date:05/05/05ISR Number: 4656839-0Report Type:Expedited (15-DaCompany Report #04P-028-0277713-00 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Foreign Epival (Depakote) Chest Discomfort Health (Divalproex Sodium) Coronary Artery Professional (Divalproex Sodium) PS ORAL 1500 MG, 1 IN Atherosclerosis Other 1 EVENING, Coronary Artery Stenosis PER ORAL Pneumonia Olanzapine SS ORAL 15 MG, 1 IN 1 Pulmonary Oedema EVENING, PER Thyroid Neoplasm ORAL Postmarketed Study Drugs SS Clonazepam C Omeprazole C Rofecoxib C Zopiclone C Date:05/09/05ISR Number: 4658127-5Report Type:Expedited (15-DaCompany Report #US_0503114606 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Study Olanzapine-Long-Acti Initial or Prolonged Condition Aggravated Health ng Im (Depot) PS 210 MG Drug Abuser Professional Schizophrenia, Undifferentiated Type Date:05/09/05ISR Number: 4658332-8Report Type:Expedited (15-DaCompany Report #US_0411107605 Age:53 YR Gender:Female I/FU:I Outcome PT Other Acute Prerenal Failure Blood Cholesterol Abnormal 24-Jun-2005 12:19 PM Page: 3622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Triglycerides Increased Cardiomegaly Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa-Oral Non-Insulin-Dependent Health (Olanzapine) Haematuria Professional (Olanzapine) PS 10 MG AT Hypotension BEDTIME Knee Arthroplasty Symbyax-Olanzapine / Obesity Fluoxetine (Ola SS Oral Intake Reduced Bupropion C Osteoarthritis Glipizide C Pneumonia Metformin C Renal Failure Acute Allegra-D C Urinary Tract Infection Premarin C Nexium (Esomeprazole Magnesium) C Lipitor (Atorvastatin Calcium) C Tolterodine L-Tartrate C Vioxx (Rofecoxib) C Multivitamin C Prozac (Fluoxetine Hydrochloride) C Aspirin (Acetylsalicylic Acid) C Zocor (Simvastatin Ratiopharm) C Prevacid (Lansoprazole) C Cyclobenzaprine C Oscal (Calcium Carbonate) C Vitamin C C Claritin (Loratadine) C Sudafed (Pseudoephedrine Hydrochloride) C Ancef (Cefazolin Sodium) C Promethazine C Date:05/09/05ISR Number: 4658381-XReport Type:Expedited (15-DaCompany Report #USA050290579 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dependence Consumer Zyprexa PS ORAL 40 MG/1 DAY Drug Effect Decreased Health Xanax Fatigue Professional (Alprazolam Dum) C Insomnia Effexor Loss Of Consciousness (Venlafaxine Movement Disorder Hydrochloride) C Nausea Librax C Prescribed Overdose Desyrel Tremor (Trazodone Vomiting Hydrochloride) C Ambien (Zolpidem 24-Jun-2005 12:19 PM Page: 3623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) C Seroquel (Quetiapine Fumarate) C Duloxetine C Date:05/09/05ISR Number: 4658385-7Report Type:Expedited (15-DaCompany Report #US_0410106356 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Consumer Zyprexa PS ORAL 10 MG Other Pancreatitis Celexa (Citalopram Hydrobromide) C Paxil (Paroxetine Hydrochloride) C Clonazepam C Carbamazepine C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Hydroxyzine C Propranolol C Date:05/09/05ISR Number: 4658387-0Report Type:Expedited (15-DaCompany Report #US_0501110274 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Health Zyprexa PS TRANSPLACENTAL UNK Initial or Prolonged Caesarean Section Professional Valium (Diazepam) C Drug Exposure During Paxel (Paroxetine Pregnancy Hydrochloride) C TRANSPLACENTAL Feeding Problem In Clonapam Newborn (Clonazepam) C TRANSPLACENTAL Neonatal Disorder Date:05/09/05ISR Number: 4658761-2Report Type:Expedited (15-DaCompany Report #FR_050306034 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zyprexa-Oral Depression Health (Olanzapine) Dyspnoea Professional (Olanzapine) PS 10 MG/1 DAY Dysuria Other Valium (Diazepam) C Persecutory Delusion Deroxat (Paroxetine Somnolence Hydrochloride) C Urinary Tract Disorder Date:05/09/05ISR Number: 4658762-4Report Type:Expedited (15-DaCompany Report #GBS050216720 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lacunar Infarction Foreign Olanzapine-Oral Initial or Prolonged Mania Health (Olanzapine) PS Other Professional Other 24-Jun-2005 12:19 PM Page: 3624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/05ISR Number: 4658769-7Report Type:Expedited (15-DaCompany Report #GBS050316885 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Olanzapine-Oral Hospitalization - Asphyxia Health (Olanzapine) PS 20 MG Initial or Prolonged Confusional State Professional Zopiclone Other Cyanosis Company (Zopliclone) C Infection Representative Antibiotics C Neglect Of Personal Other Appearance Pulmonary Embolism Snoring Weight Increased Date:05/09/05ISR Number: 4658938-6Report Type:Expedited (15-DaCompany Report #EWC050343070 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Foreign Zyprexa-Oral Increased Health (Olanzapine) Increased Appetite Professional (Olanzapine) PS 5 MG Metabolic Syndrome Other Fluctin-Oral Weight Increased (Fluoxetine) (Fluoxetine Hydrochlrode SS 20 MG Date:05/09/05ISR Number: 4658940-4Report Type:Expedited (15-DaCompany Report #EWC050142236 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Foreign Zyprexa-Oral Torticollis Health (Olanzapine) Professional (Olanzapine) PS 10 MG Other Naltrexone C Date:05/09/05ISR Number: 4658946-5Report Type:Expedited (15-DaCompany Report #EWC041241633 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Foreign Olanzapine-Oral Hospitalization - Drug Interaction Health (Olanzapine) PS 30 MG/1 DAY Initial or Prolonged Gastrointestinal Necrosis Professional Nozinan Megacolon Company (Levomepromazine) C Respiratory Arrest Representative Biperiden C Vomiting Other Date:05/09/05ISR Number: 4658949-0Report Type:Expedited (15-DaCompany Report #FR_050105702 Age:57 YR Gender:Female I/FU:F Outcome PT Hospitalization - Cough Initial or Prolonged Dyspnoea Oxygen Saturation Decreased Refusal Of Treatment By Patient Respiratory Failure 24-Jun-2005 12:19 PM Page: 3625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wheezing Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG/1 DAY Company Effexor (Venlafaxine Representative Hydrochloride) C Other Valium (Diazepam) C Sulfarlem (Anethole Trithione) C Phenergan (Promethazine Hydrochloride) C Vasten (Pravastatin Sodium) C Chondrosulf (Chondroitin Sulfate Sodium) C Clarityne (Loratadine) C Buspar (Buspirone Hydrochloride) C Date:05/10/05ISR Number: 4658669-2Report Type:Direct Company Report #CTU 248111 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperhidrosis Clozapine 100mg Intervention to Neuroleptic Malignant Zenith PS Zenith ORAL 350MG Prevent Permanent Syndrome BEDTIME ORAL Impairment/Damage Olanzapine 20mg Lilly SS Lilly ORAL 20MG BEDTIME ORAL Fluoxetine C Lorazepam C Multivitamin C Risperidone C Date:05/10/05ISR Number: 4659386-5Report Type:Expedited (15-DaCompany Report #FR_050205740 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthyroidism Foreign Zyprexa PS ORAL 1 DSG FORM Initial or Prolonged Hypokalaemia Health DAY Polydipsia Professional Zoloft Polyuria Other (Sertraline Quadriparesis Hydrochloride) C Lysanxia (Prazepam) C Date:05/10/05ISR Number: 4659387-7Report Type:Expedited (15-DaCompany Report #GBS050216720 Age:47 YR Gender:Male I/FU:F Outcome PT Hospitalization - Confusional State Initial or Prolonged Economic Problem Other Lacunar Infarction 24-Jun-2005 12:19 PM Page: 3626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mania Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine PS ORAL Health Professional Other Date:05/10/05ISR Number: 4659792-9Report Type:Expedited (15-DaCompany Report #US_0411107616 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Consumer Zyprexa PS ORAL 25 MG DAY 505 DAY Initial or Prolonged Phosphokinase Increased Health Seroquel Other Blood Glucose Increased Professional (Quetiapine Cardio-Respiratory Arrest Fumarate) C Depressed Level Of Symbyax C Consciousness Afo-Divalproex Mania Prescribed Overdose (Valproate Psychotic Disorder Semisodium) C Weight Increased Glucophage (Metformin) C Glyset (Miglitol) C Starlix (Nateglinide) C Actos (Pioglitazone Hydrochloride) C Avandia (Rosiglitazone Maleate) C Zoloft (Sertraline Hydrochloride) C Sonata (Zaleplon) C Miralax (Macrogol) C Tricor (Fenofibrate) C Altace (Ramipril Dura) C Pletal (Cilostazol) C Date:05/10/05ISR Number: 4659793-0Report Type:Expedited (15-DaCompany Report #US_0411107616 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Zyprexa PS ORAL 25 MG DAY 124 WK Initial or Prolonged Blood Creatine Health Seroquel Other Phosphokinase Increased Professional Blood Glucose Increased (Quetiapine Diabetes Mellitus Fumarate) C Loss Of Consciousness Symbyax C Prescribed Overdose Apo-Divalproex Psychotic Disorder (Valproate Respiratory Arrest Semisodium) C Weight Increased Glucophage (Metformin) C Glyset (Miglitol) C Starlix (Nateglinide) C Actos (Pioglitazone 24-Jun-2005 12:19 PM Page: 3627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Avandia (Rosiglitazone Maleate) C Zoloft (Sertraline Hydrochloride) C Sonata (Zaleplon) C Miralax (Macrogol) C Tricor (Fenofibrate) C Altace (Ramipril Dura) C Pletal (Cilostazol) C Date:05/10/05ISR Number: 4659794-2Report Type:Expedited (15-DaCompany Report #USA050494989 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Symbyax PS Hospitalization - Acidosis Professional Zyprexa SS ORAL 2. 5 MG Initial or Prolonged Agitation Company Cymbalta Other Blood Glucose Decreased Representative Coma (Duloxetine Ear Pain Hydrochloride) SS 60 MG/1 DAY Emotional Distress Synthroid Fatigue (Levothyroxine Fear Sodium) C Gastrointestinal Macrobid Haemorrhage (Nitrofurantoin) C Hallucination Xanax (Alprazolam Hepatic Failure Dum) C Hepatic Necrosis Tamiflu (Oseltamivir Hypoaesthesia Phosphate) C Influenza Like Illness Levaquin Insomnia (Levofloxacin) C Overdose Zyrtec (Cetirizine Pharyngolaryngeal Pain Hydrochloride) C Relationship Breakdown Flonase (Fluticasone Propionate) C Tylenol Pm C Date:05/10/05ISR Number: 4659796-6Report Type:Expedited (15-DaCompany Report #US_0505116924 Age:41 YR Gender:Female I/FU:I Outcome PT Death Blood Cholesterol Life-Threatening Increased Blood Glucose Fluctuation Cardiac Arrest Diabetes Mellitus Non-Insulin-Dependent Glycosylated Haemoglobin Increased Hyperglycaemia Ingrowing Nail Low Density Lipoprotein Decreased Pupil Fixed Treatment Noncompliance Urinary Tract Infection Ventricular Fibrillation 24-Jun-2005 12:19 PM Page: 3628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Fluctuation Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa PS ORAL 15 MG/1 AT Health BEDTIME Professional Prozac (Fluoxetine Hydrochloride) C Buspar (Buspirone Hydrochloride) C Divalproex Sodium C Trazodone C Celexa (Citalopram Hydrobromide) C Atorvastatin C Norvasc (Amlodipine) C Estropipate C Hydrochlorothiazide C Lisinopril C Xanax (Alprazolam Dum) C Lopid (Gemfibrozil) C Date:05/10/05ISR Number: 4659902-3Report Type:Expedited (15-DaCompany Report #CA_050408067 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Hydatidiform Mole Foreign Olanzapine-Oral Drug Exposure During Health (Olanzapine) PS 10 MG/1 AT Pregnancy Professional BEDTIME Pregnancy Date:05/12/05ISR Number: 4661493-8Report Type:Direct Company Report #CTU 248326 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Olanzapine Zydis Decreased -Zyprexa- 15 Mg Lilly PS Lilly ORAL 15 MG HS ORAL Docusate C Tolfanate Powder C Date:05/12/05ISR Number: 4662259-5Report Type:Expedited (15-DaCompany Report #US_0502111957 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystocele Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Haematemesis Professional (Olanzapine) PS 20 MG/1 AT Haemoptysis BEDTIME Rectocele Symbyax C Stress Incontinence Alprazolam C Wellbutrin (Bupropion Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paxil (Paracetamol Hydrochloride) C Trazadone (Trazadone) C Amaryl (Glimepiride) C Tenormin (Atenolol Eg) C Valium (Diazepam) C Prevacid (Lansoprazole) C Propulsid (Cisapride) C Centrum C Ambien (Zolpidem Tartrate) C Premarin C Zithromax (Azithromycin) C Estrace (Estradiol) C Tricor (Fenofibrate) C Zetia (Ezetimibe) C Prilosec (Omeprazole Rathiopharm) C Pravachol (Pravastatin Sodium) C Lopid (Gemfibrozil) C Crestor (Rosuvastatin Calcium) C Date:05/12/05ISR Number: 4662262-5Report Type:Expedited (15-DaCompany Report #US_0504116050 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zyprexa-Oral Other Cardiomegaly Professional (Olanzapine) Hypothyroidism Other (Olanzapine) PS 7.5 MG/2 DAY White Blood Cell Count Clozapine C Increased Date:05/12/05ISR Number: 4662263-7Report Type:Expedited (15-DaCompany Report #US_0410106997 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Consumer Zyprexa-Oral Other Drug Toxicity (Olanzapine) Electrocardiogram (Olanzapine) PS Abnormal Loss Of Consciousness Date:05/12/05ISR Number: 4662264-9Report Type:Expedited (15-DaCompany Report #USA050494681 Age:65 YR Gender:Male I/FU:I Outcome PT Hospitalization - Effusion Initial or Prolonged Extrapyramidal Disorder Lung Disorder Post Procedural 24-Jun-2005 12:19 PM Page: 3630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Complication Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 20 MG/1 DAY Representative Celexa (Citalopram Hydrobromide) C Pravacid (Lansopraozle) C Maxzide C Date:05/12/05ISR Number: 4662290-XReport Type:Expedited (15-DaCompany Report #USA050496814 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zyprexa-Oral Hospitalization - Loss Of Consciousness Professional (Olanzapine) Initial or Prolonged Company (Olanzapine) PS Representative Date:05/12/05ISR Number: 4662291-1Report Type:Expedited (15-DaCompany Report #US_0411107651 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Non-Insulin-Dependent Health (Olanzapine) Dry Mouth Professional (Olanzapine) PS 5 MG DAY Epistaxis Abilify Hypertension (Aripiprazole) C Injury Avandia Malaise (Rosiglitazone Maleate) C Avandamet C Amlodipine C Atorvastatin C Haloperidol C Date:05/12/05ISR Number: 4662292-3Report Type:Expedited (15-DaCompany Report #US_0411107613 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Disease Recurrence Health (Olanzapine) Other Erosive Oesophagitis Professional (Olanzapine) PS 15 MG Gastrointestinal Prozac-Oral Haemorrhage (Fluoxetine) Hepatitis C (Dluoxetine Hyperlipidaemia Hydrochloride0 SS Liver Disorder Symbyax-Olanzapine/F Mood Disorder Due To A luoxetine (Unknown General Medical Condition Dose)(Ola C Pancreatic Enlargement Seroquel (Quetiapine Pancreatitis Fumarate) C Peptic Ulcer Geodon (Ziprasidone Weight Fluctuation Hydrochloride) C Depakote (Valproate Semisodium) C 24-Jun-2005 12:19 PM Page: 3631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Remeron (Mirtazapine Orifarm) C Serozone (Nefazodone Hydrochloride) C Effexor (Vnlafazine Hydrochloride) C Glucophate (Metformin) C Trazadone (Trazadone) C Neurontin (Gabapentin Pfizer) C Xanax (Alprazolam Dum) C Lasix (Furosemide) C Kcl (Potassium Chloride) C Klonopin (Clonazepam) C Trazodone C Hydroxyzine C Bupropion C Ritalin (Methylphenidate Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Prinivil (Lisinopril) C Date:05/12/05ISR Number: 4662341-2Report Type:Expedited (15-DaCompany Report #USA041184234 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG Seroquel (Quetiapine Fumarate) C Cogentin (Benzatropine Mesilate0 C Clonazepam C Depakote (Valproate Semisodium) C Date:05/12/05ISR Number: 4662356-4Report Type:Expedited (15-DaCompany Report #USA050290523 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Zyprexa-Oral Hospitalization - Agitation Professional (Olanzapine) Initial or Prolonged Circulatory Collapse Company (Olanzapine) PS 10 MG Other Myocardial Infarction Representative Zyprexa-Rapid-Acting Pulmonary Embolism Im(Olanzapine) SS Sudden Death 24-Jun-2005 12:19 PM Page: 3632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4662370-9Report Type:Expedited (15-DaCompany Report #USA050291922 Age:97 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG DAY Date:05/12/05ISR Number: 4662523-XReport Type:Expedited (15-DaCompany Report #JP_041004698 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zyprexa-Oral Hospitalization - Increased Literature (Olanzapine) Initial or Prolonged Aspartate Health (Olanzapine) PS 10 MG DAY Aminotransferase Professional Depakene (Valproate Increased Company Sodium) C Blood Lactate Representative Limas (Lithium Dehydrogenase Increased Other Carbonate) C Cytomegalovirus Infection Furosemide Drug Hypersensitivity (Furosemide) C Eosinophil Percentage Magnesium Oxide C Increased Lendormin False Positive Laboratory (Brotizolam) C Result Mucodyne Human Herpes Virus 6 (Carbocisteine) C Serology Positive Lymphadenopathy Lymphocyte Morphology Abnormal Photosensitivity Reaction Restlessness Skin Test Positive White Blood Cell Count Increased Date:05/12/05ISR Number: 4662537-XReport Type:Expedited (15-DaCompany Report #2005041391 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zoloft (Sertraline) PS ORAL 50 MG, ORAL Initial or Prolonged Delirium Consumer Olanzapine Drug Interaction Health (Olanzapine) SS ORAL 5 MG, ORAL Drug Level Increased Professional Memantine Fumbling (Memantine) SS ORAL 5 MG, ORAL Hallucination, Visual Restlessness Date:05/12/05ISR Number: 4662603-9Report Type:Expedited (15-DaCompany Report #US_0505116923 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Decreased Foreign Zyprexa-Rapid-Acting Disease Recurrence Health Im (Olanzapine) PS 10 MG/2 DAY Somnolence Professional Valproic (Valproic Other Acid) C Rivotril (Clonazepam) C 24-Jun-2005 12:19 PM Page: 3633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4662627-1Report Type:Expedited (15-DaCompany Report #JP_050406238 Age:4 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Zyprexa-Oral Initial or Prolonged Drug Exposure During Health (Olanzapine) Pregnancy Professional (Olanzapine) PS Drug Exposure Via Breast Company Tetramide (Mianserin Milk Representative Hydrochloride) C Drug Withdrawal Syndrome Other Neonatal Gastrointestinal Disorder Hypocalcaemia Irritability Neonatal Disorder Premature Baby Respiratory Disorder Neonatal Transient Tachypnoea Of The Newborn Tremor Neonatal Date:05/12/05ISR Number: 4662631-3Report Type:Expedited (15-DaCompany Report #EWC050443716 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Olanzapine-Oral Initial or Prolonged Insomnia Health (Olanzapine) PS 10 MG/1 DAY Paradoxical Drug Reaction Professional Lithium C Physical Assault Other Serenase Tension (Haloperidol) C Largactil (Chlorpromazine Hydrochloride) C Nozinan (Levomepromazine Hydrochloride) C Halcion (Triazolam) C Seroquel (Quetiapine Fumarate) C Lorazepam C Flurazepam C Date:05/12/05ISR Number: 4662633-7Report Type:Expedited (15-DaCompany Report #EWC050443693 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Olanzapine-Oral Hospitalization - Diarrhoea Health (Olanzapine) PS 5 MG/2 DAY Initial or Prolonged Faeces Discoloured Professional Coumadin (Warfarin Pallor Other Sdoium) C Vomiting Lanoxin (Digoxin-Sandoz) C 24-Jun-2005 12:19 PM Page: 3634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4662638-6Report Type:Expedited (15-DaCompany Report #EWC050443735 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Foreign Zyprexa-Oral Pregnancy Health (Olanzapine) Renal Agenesis Professional (Olanzapine) PS Other Date:05/12/05ISR Number: 4662665-9Report Type:Expedited (15-DaCompany Report #CA_050408076 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Olanzapine-Oral Initial or Prolonged Thromboplastin Time Literature (Olanzapine) PS 700 MG OTHER 3 MON Prolonged Health Antiphospholipid Syndrome Professional Complex Partial Seizures Deep Vein Thrombosis Depressed Level Of Consciousness Drug Effect Decreased Hallucination, Auditory Hypertension Miosis Overdose Pneumonia Aspiration Pulmonary Embolism Suicidal Ideation Weight Increased Date:05/12/05ISR Number: 4662748-3Report Type:Expedited (15-DaCompany Report #DE_040814216 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Zyprexa-Oral Initial or Prolonged Positive Health (Olanzapine) Other Autoimmune Hepatitis Professional (Olanzapine) PS 2.5 MG DAY Dementia Other Candesartan Systemic Lupus Cilexetil Erythematosus W/Hydrochlorothiazid e C Ass (Acetylsalicylic Acid) C Dipiperon/Gfr/(Pipam perone) C Date:05/12/05ISR Number: 4662751-3Report Type:Expedited (15-DaCompany Report #FR_050105704 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Foreign Zyprexa-Oral Initial or Prolonged Health (Olanzapine) Professional (Olanzapine) PS Other 24-Jun-2005 12:19 PM Page: 3635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4662752-5Report Type:Expedited (15-DaCompany Report #EWC050443713 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS Other Sintrom (Acenocoumarol) C Digoxine C Diovan C Date:05/12/05ISR Number: 4662793-8Report Type:Expedited (15-DaCompany Report #FR_050406285 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Zyprexa-Oral Initial or Prolonged Azotaemia Health (Olanzapine) Cardiac Discomfort Professional (Olanzapine) PS 20 MG DAY Condition Aggravated Other Tegretol Eyelid Oedema (Carbamazepine Hypertensive Crisis Rivopharm) C Mania Teralithe (Lithium Oedema Peripheral Carbonate) C Treatment Noncompliance Ventricular Hypertrophy Date:05/12/05ISR Number: 4662794-XReport Type:Expedited (15-DaCompany Report #EWC050543795 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Drug Toxicity Health (Olanzapine) Intentional Self-Injury Professional (Olanzapine) PS Other Chlordemetildiazepam C Buprenorphine C Date:05/12/05ISR Number: 4662795-1Report Type:Expedited (15-DaCompany Report #GBS050417235 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Olanzapine-Oral Drug Interaction Health (Olanzapine) PS 1 DSG FORM IN Psychotic Disorder Professional THE EVENING Other Xenical (Orlistat) C Amisulpride C Acamprostate C Disulfiram C Zopiclone C Epilim Chrono (Valproate Sodium) C Thiamine C Vitamin B Complex C Trazodone C 24-Jun-2005 12:19 PM Page: 3636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4662796-3Report Type:Expedited (15-DaCompany Report #FR_050406284 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Zyprexa-Oral Initial or Prolonged Drug Dependence Health (Olanzapine) Drug Screen Positive Professional (Olanzapine) PS Other Atarax (Alprazolam Dum) C Tercian (Cyamemazine) C Valium (Diazepam) C Aerius (Desloratadine) C Date:05/12/05ISR Number: 4662797-5Report Type:Expedited (15-DaCompany Report #US_0504116143 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Foreign Zyprexa-Oral Hospitalization - Urinary Retention Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 5 MG Other Date:05/12/05ISR Number: 4662798-7Report Type:Expedited (15-DaCompany Report #JP_050406435 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zyprexa-Oral Initial or Prolonged Agitation Literature (Olanzapine) Akinesia Health (Olanzapine) PS 20 MG DAY Amnesia Professional Paroxetine C Anxiety Other Compulsions Decreased Appetite Disorientation Euphoric Mood Excitability Fall Feeling Abnormal Feeling Guilty Humerus Fracture Insomnia Mutism Psychotic Disorder Refusal Of Treatment By Patient Restlessness Suicide Attempt Thinking Abnormal Date:05/12/05ISR Number: 4662799-9Report Type:Expedited (15-DaCompany Report #JP_030601208 Age:69 YR Gender:Female I/FU:F Outcome PT Life-Threatening Autonomic Neuropathy Hospitalization - Body Temperature Initial or Prolonged Fluctuation Condition Aggravated 24-Jun-2005 12:19 PM Page: 3637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dystonia Extrapyramidal Disorder Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration On And Off Phenomenon Foreign Zyprexa-Oral Psychiatric Symptom Literature (Olanzapine) Pyrexia Health (Olanzapine) PS 2.5 MG DAY Respiratory Arrest Professional Permax (Pergolide Respiratory Disorder Company Mesylate) SS 750 UG DAY Respiratory Failure Representative Symmetrel Soliloquy Other (Amantadine Suicidal Ideation Hydrochloride) C Temperature Regulation Levodopa Benserazode Disorder Hydrochlo C Vocal Cord Disorder Depromel (Fluvoxamine) C Thyradin S (Levothyroxine Sodium) C Pantosin (Pantethine) C Magnesium Oxide C Date:05/12/05ISR Number: 4662800-2Report Type:Expedited (15-DaCompany Report #GBS050316885 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Olanzapine-Oral Hospitalization - Confusional State Health (Olanzapine) PS 20 MG Initial or Prolonged Cyanosis Professional Zopiclone C Other Impaired Self-Care Company Antibiotics C Infection Representative Pulmonary Embolism Other Snoring Weight Increased Date:05/12/05ISR Number: 4662801-4Report Type:Expedited (15-DaCompany Report #GBS050417154 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Olanzapine-Oral Initial or Prolonged Increased Health (Olanzapine) PS Blood Alkaline Professional Efexor Xl Phosphatase Increased Other (Venlafaxine Gamma-Glutamyltransferase Hydrochloride) C Increased Efexor (Venlafaxine) C Intestinal Obstruction Lithium C Mirtazapine C Date:05/12/05ISR Number: 4662802-6Report Type:Expedited (15-DaCompany Report #JP_050306162 Age:20 YR Gender:Female I/FU:F Outcome PT Hospitalization - Depressive Symptom Initial or Prolonged Electroencephalogram Other Abnormal Insomnia Irritability Nightmare 24-Jun-2005 12:19 PM Page: 3638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Petit Mal Epilepsy Psychiatric Symptom Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 25 MG DAY Company Pantosin Representative (Pantethine) C Other Magnesium Oxide C Sennoside (Sennoside A+B Calcium) C Paxil (Paroxetine Hydrochloride) C Marzulene S C Depakene-R /Jpn/(Valproate Sodium) C Reslin (Trazodone Hydrochloride) C Hyserenin (Valproate Sodium) C Risperdal (Risperidone) C Hiberna (Promethazine Hydrochloride) C Depromel (Fluvoxamine) C Date:05/12/05ISR Number: 4662803-8Report Type:Expedited (15-DaCompany Report #GBS050216720 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Olanzapine-Oral Initial or Prolonged Economic Problem Health (Olanzapine) PS Other Lacunar Infarction Professional Mania Other Treatment Noncompliance Date:05/12/05ISR Number: 4662804-XReport Type:Expedited (15-DaCompany Report #FR_050105688 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Zyprexa-Oral Initial or Prolonged Phosphatase Increased Health (Olanzapine)(Olanzap Cerebral Atrophy Professional ine) PS 5 MG/1 DAY Creutzfeldt-Jakob Disease Other Temesta (Lorazepam) C Disorientation Allopurinol C Dysprosody Plavix (Clopidogrel Electroencephalogram Sulfate) C Abnormal Ivermectin C Encephalopathy Eosinophilia Myoclonus 24-Jun-2005 12:19 PM Page: 3639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4662805-1Report Type:Expedited (15-DaCompany Report #JP_040202677 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Study (Olanzapine) Aspartate Health (Olanzapine) PS 10 MG/1 DAY Aminotransferase Professional Ciproxan Increased Other (Ciprofloxacin Blood Lactate Hydrochloride) C Dehydrogenase Increased Serenace Hepatic Function Abnormal (Haloperidol) C Pyrexia Akineton (Biperiden Hydrochloride) C Diazepam C Rohypnol (Flunitrazepam) C Date:05/12/05ISR Number: 4662816-6Report Type:Expedited (15-DaCompany Report #USA050496487 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa Other Depressed Mood Professional Family Stress Company (Olanzapine) PS ORAL 10 MG/1 DAY Representative Effexor (Venlafaxine Hydrochloride) C Lipitor (Atorvastatin Calcium) C Lorazepam C Neurontin (Gabapentin) C Date:05/12/05ISR Number: 4662817-8Report Type:Expedited (15-DaCompany Report #USA050496477 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS ORAL 10 MG DAY Representative Trazodone C Darvocet-N 100 C Sonata (Zaleplon) C Date:05/13/05ISR Number: 4661411-2Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0557599A Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Lamictal PS Glaxosmithkline ORAL 100MG Per day Neutropenia Zyprexa SS UNKNOWN 30MG Per day 11 DAY Pyrexia Clopixol C Respiratory Acidosis Flurazepam Hydrochloride C Nozinan C Procyclidine C Glaxosmithkline Topomax C 24-Jun-2005 12:19 PM Page: 3640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/05ISR Number: 4661534-8Report Type:Periodic Company Report #ES-JNJFOC-20050403843 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Olanzapine SS OROPHARINGEAL Date:05/16/05ISR Number: 4663781-8Report Type:Expedited (15-DaCompany Report #US_0412109582 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Consumer Zyprexa-Oral Other Diabetes Mellitus Health (Olanzapine) Inadequate Control Professional (Olanzapine) PS 10 MG Haematemesis Protonix Pancreatitis (Pantoprazole) C Weight Increased Remeron (Mirtazapine Orifarm) C Diovan Hct C Effexor-Xr (Venlafaxine Hydrochloride) C Oxycodone/Apap C Vicoprofen C Cleocin (Clindamycin Hydrochloride) C Clonazepam C Ultracet C Aciphex (Rabeprazole Sodium) C Neurontin (Gabapentin Pfizer) C Metoclopramide C Levaquin (Levofloxacin) C Divalproex Sodium C Mirtazapine C Venlafaxine C Date:05/16/05ISR Number: 4663783-1Report Type:Expedited (15-DaCompany Report #US_0410106496 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zyprexa-Oral Initial or Prolonged Biliary Dilatation Health (Olanzapine) Other Diabetes Mellitus Professional (Olanzapine) PS 10 MG/1 AT Gastritis BEDTIME Hepatic Cirrhosis Olanzapine Hepatic Steatosis /Fluoxetine Capsule C Hepatitis Risperdal Hepatomegaly (Risperidone) C Impaired Gastric Emptying Metformin C Synthroid (Levothyroxine Sodium) C Atenolol C Allegra (Flexofenadine Hydrochloride) C Combivent C 24-Jun-2005 12:19 PM Page: 3641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Norvasc (Amlodipine0 C Zoloft (Sertraline Hydrochloride) C Bupropion C Citalopram I C Date:05/16/05ISR Number: 4663811-3Report Type:Expedited (15-DaCompany Report #2005068728 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Consumer Celebrex (Celecoxib) PS Hospitalization - Aggression Bextra (Valdecoxib) SS 20 MG (20 MG, Initial or Prolonged Antidepressant Drug Level 1 IN 1 D) Increased Lithium SS Dementia Olanzapine SS Difficulty In Walking Asasantin Drug Effect Decreased (Acetylsalicylic Dyskinesia Acid, Dipyridamole) C Erythema Fosinopril Sodium C Helicobacter Infection Valproate Semisodium C Myocardial Infarction Levothyroxine Sodium C Pruritus Generalised Potassium C Quetiapine Fumarate C Atenolol C Metformin Hydrochloride C Minoxidil C Fosinopril Sodium C Furosemide C Simvastatin C Rosiglitazone Maleate C Date:05/16/05ISR Number: 4664010-1Report Type:Direct Company Report #CTU 248624 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Olanzapine PS 2.5 MG DAILY Initial or Prolonged Disability Date:05/17/05ISR Number: 4664916-3Report Type:Expedited (15-DaCompany Report #DE_041014538 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Foreign Zyprexa-Rapid-Acting Sedation Health Im (Olanzapine) PS 10 MG/1 DAY Professional Tavor (Lorazepam) C Company Valproic Acid C Representative Lyogen Other (Fluphenazine) C Lyogen (Fluphenazine Decaonate) C Truxal (Chlorprothixene Hydrochloride) C Dipiperon (Pimpamperone 24-Jun-2005 12:19 PM Page: 3642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Akineton Retard (Biperiden Hydrochloride) C Euthyrox (Levothyroxine Sodium) C Cexane (Enoxaparin Sodium) C Date:05/17/05ISR Number: 4664917-5Report Type:Expedited (15-DaCompany Report #EWC050142155 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Olanzapine-Rapid-Act Life-Threatening Cardiac Arrest Health ing Im PS 10 MG Oesophageal Varices Professional Rivotril Haemorrhage (Clonazepam) C Shock Date:05/17/05ISR Number: 4664981-3Report Type:Expedited (15-DaCompany Report #CA_050508115 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Dystrophy Foreign Zyprexa-Oral Visual Acuity Reduced Consumer (Olanzapine) Other (Olanzapine) PS 2.5 MG DAY Date:05/17/05ISR Number: 4664990-4Report Type:Expedited (15-DaCompany Report #EWC041241809 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Foreign Zyprexa Initial or Prolonged Transient Ischaemic Health Attack Professional (Olanzapine) PS ORAL 10 MG/1 DAY Company Trilafon Representative Other (Perphenazine Enantate) C Date:05/17/05ISR Number: 4664992-8Report Type:Expedited (15-DaCompany Report #EWC041141519 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa PS ORAL Life-Threatening Fatigue Health Hospitalization - General Physical Health Professional Initial or Prolonged Deterioration Company Other Grand Mal Convulsion Representative Hypotension Other Loss Of Consciousness Myocardial Ischaemia Oedema Peripheral Orthostatic Hypotension Peripheral Circulatory Failure Syncope 24-Jun-2005 12:19 PM Page: 3643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4664996-5Report Type:Expedited (15-DaCompany Report #DE_050315434 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zyprexa PS ORAL 5 MG DAY Initial or Prolonged Delirium Health Zoloft Drug Interaction Professional Drug Level Increased Other (Sertraline Hallucination, Visual Hydrochloride) C Infection Axura Restlessness (Memantine Hydrochloride) C Date:05/17/05ISR Number: 4665042-XReport Type:Expedited (15-DaCompany Report #DE_050415789 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Zyprexa PS ORAL 10 MG DAY Constipation Consumer Melperone C Dry Mouth Other Ciatyl Fall (Clopenthixol Pneumonia Hydrochloride) C Pyothorax Tremor Date:05/17/05ISR Number: 4665070-4Report Type:Expedited (15-DaCompany Report #JP_050506499 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Foreign Zyprexa-Oral Other Electrocardiogram Qt Health (Olanzapine) Corrected Interval Professional (Olanzapine) PS 10 MG DAY Prolonged Company Dogmatyl (Sulpiride0 C Hypokalaemia Representative Akineton (Biperiden Oedema Other Lactate) C Ventricular Extrasystoles Pyrethia (Promethazine Hydrochloride) C Pantethine C Magnesium Oxide C Protoporphyrin Disodium C Midodrine Hydrochloride C Etilefrine Hydrochloride C Yodel (Senna Alexandrina) C Reslart (Cetraxate Hydrochlordie) C Date:05/17/05ISR Number: 4665071-6Report Type:Expedited (15-DaCompany Report #JP_050506492 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis Fulminant Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Other Chloropromazine C 24-Jun-2005 12:19 PM Page: 3644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lullan (Perospirone Hydrochloride) C Wypax (Lorazepam) C Lasix (Furosemide) C Date:05/17/05ISR Number: 4665072-8Report Type:Expedited (15-DaCompany Report #FR_050506356 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zyprexa-Oral Initial or Prolonged Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 1 DSG FORM/1 Aminotransferase Other DAY Increased Augmentin C Blood Alkaline Tranxene Phosphatase Increased (Clorazepate Blood Bilirubin Increased Dipotassium) C Blood Bilirubin Anafranil Unconjugated Increased (Clomipramine Cholestasis Hydrochloride) C Gamma-Glutamyltransferase Oflocet (Ofloxacin) C Increased Vasten (Pravastatin Lipase Increased Sodium) C Vastrarel (Trimetazindine Hydrochloride) C Nitriderm Tts (Glyceryl Trinitrate) C Seresta (Oxazepam) C Tercian (Cyamemazine) C Kardegic (Acetylsalicylate Lysine) C Date:05/17/05ISR Number: 4665073-XReport Type:Expedited (15-DaCompany Report #GBS050517279 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Zyprexa-Oral Initial or Prolonged Non-Insulin-Dependent Consumer (Olanzapine) Other Dialysis Other (Olanzapine) PS Pain Pancreatic Disorder Date:05/17/05ISR Number: 4665074-1Report Type:Expedited (15-DaCompany Report #FR_050506348 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Zyprexa-Oral Initial or Prolonged Pregnancy Health (Olanzapine) Other Foot Fracture Professional (Olanzapine) PS 20 MG/1 DAY Grand Mal Convulsion Other Nozinan Pelvic Fracture (Levomepromazine) C Pregnancy Temesta (Lorazepam) C Suicide Attempt Anafranil (Clomipramine 24-Jun-2005 12:19 PM Page: 3645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:05/17/05ISR Number: 4665075-3Report Type:Expedited (15-DaCompany Report #FR_050406344 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Dose Omission Foreign Zyprexa-Oral Drug Withdrawal Syndrome Health (Olanzapine) Professional (Olanzapine) PS 3 DSG FORM Other DAY Prozac (Fluoxetine Hydrochloride) C Methadone C Tercian (Cyamemazine) C Imovane (Zopiclone) C Lysanxia (Prazepam) C Interferon C Ribavirin C Date:05/17/05ISR Number: 4665076-5Report Type:Expedited (15-DaCompany Report #FR_050406330 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Zyprexa-Oral Hospitalization - Death Neonatal Health (Olanzapine) Initial or Prolonged Drug Exposure During Professional (Olanzapine) PS Pregnancy Other Foetal Macrosomia Neonatal Disorder Date:05/17/05ISR Number: 4665077-7Report Type:Expedited (15-DaCompany Report #FR_041105163 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Foreign Zyprexa-Oral Pregnancy Health (Olanzapine) Gestational Diabetes Professional (Olanzapine) PS 20 MG/1 DAY Stillbirth Other Date:05/17/05ISR Number: 4665078-9Report Type:Expedited (15-DaCompany Report #EWC050543900 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Olanzapine-Oral Initial or Prolonged Hepatic Fibrosis Consumer (Olanzapine) PS 5 MG/1 DAY Road Traffic Accident Other Fenobarbital C Dintoina (Phenoytoin Sodium) C Date:05/17/05ISR Number: 4665079-0Report Type:Expedited (15-DaCompany Report #EWC050242784 Age:62 YR Gender:Female I/FU:I Outcome PT Other Alanine Aminotransferase Increased Aspartate 24-Jun-2005 12:19 PM Page: 3646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Asthenia Chest Pain Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Change Foreign Zyprexa-Oral Enzyme Abnormality Health (Olanzapine) Haematemesis Professional (Olanzapine) PS 5 MG/1 DAY Nausea Company Lithuril (Lithium Vomiting Representative Carbonate) C Other Ativan (Lorazepam) C Date:05/17/05ISR Number: 4665097-2Report Type:Expedited (15-DaCompany Report #JP_050406343 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Foreign Zyprexa-Oral Vaginal Haemorrhage Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Company Rohypnol Representative (Flunitrazepam Eg) C Other Furosemide (Furosemide) C Depakene (Valproate Sodium) C Date:05/17/05ISR Number: 4665146-1Report Type:Expedited (15-DaCompany Report #FR_050406291 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Company Representative Other Date:05/17/05ISR Number: 4665147-3Report Type:Expedited (15-DaCompany Report #FR_050406288 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 10 MG/1 DAY Company Representative Other Date:05/17/05ISR Number: 4665148-5Report Type:Expedited (15-DaCompany Report #EWC050543795 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Drug Toxicity Health (Olanzapine) Intentional Misuse Professional (Olanzapine) PS Intentional Self-Injury Other Chlordemetildiazepam C Overdose Buprenorphine C 24-Jun-2005 12:19 PM Page: 3647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4665149-7Report Type:Expedited (15-DaCompany Report #FR_050406202 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Zyprexa-Oral Initial or Prolonged Delusion Health (Olanzapine) Hallucination Professional (Olanzapine) PS 5 MG DAY Other Rosuvastatin Calcium C Date:05/17/05ISR Number: 4665240-5Report Type:Expedited (15-DaCompany Report #USA050597179 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Zyprexa-Oral Increased Professional (Olanzapine) Aspartate (Olanzapine) PS 7.5 MG DAY Aminotransferase Beta Blockers C Increased Remeron (Mirtazapine Blood Alkaline Orifarm) C Phosphatase Increased Colon Cancer Date:05/17/05ISR Number: 4665242-9Report Type:Expedited (15-DaCompany Report #USA040157139 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Zyprexa-Oral Abdominal Pain Upper (Olanzapine) Alcoholism (Olanzapine) PS 20 MG/1 DAY Depressed Mood Zoloft (Sertraline Faeces Pale Hydrochloride) C Feeling Abnormal Paxil (Paroxetine Heart Rate Increased Hydrochloride) C Hepatic Failure Hepatomegaly Insomnia Nervousness Pancreatic Disorder Paranoia Tension Weight Fluctuation Date:05/17/05ISR Number: 4665289-2Report Type:Expedited (15-DaCompany Report #US_0411107659 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Symbax-Olanzapine / Initial or Prolonged Blood Glucose Increased Fluoxetine (Unknown Other Blood Triglycerides Dose) (Ola PS Increased Zyprexa-Oral Diabetes Mellitus (Olanzapine) Furuncle (Olanzapine) SS 20 MG/1 DAY Herpes Simplex Amaryl (Glimepiride) C Hypoglycaemia 24-Jun-2005 12:19 PM Page: 3648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4665290-9Report Type:Expedited (15-DaCompany Report #USA050597132 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Symbiax-Olanzapine Professional 12 Mg / Fluoxetine 50 Mg (Olanzapi PS Valium(Diazepam) C Fentanyl C Date:05/17/05ISR Number: 4665628-2Report Type:Expedited (15-DaCompany Report #US_0410106934 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa-Oral Amnesia Professional (Olanzapine) Arthritis (Olanzapine) PS 25 MG DAY Blood Alkaline Prozac (Fluoxetine Phosphatase Increased Hydrochloride) C Blood Bicarbonate Promethazine C Decreased Doxycycline C Blood Chloride Increased Lorazepam C Blood Glucose Increased Topamax (Topiramate) C Borderline Personality Verapamil C Disorder Synthroid Cardiac Disorder (Levothyroxine Cervix Carcinoma Stage I Sodium) C Coordination Abnormal Lustra Cream C Depression Cylert (Pemoline Diabetes Mellitus Magnesium) C Non-Insulin-Dependent Prilosec (Omeprazole Difficulty In Walking Ratiopharm) C Drug Abuser Novahistine Elixir C Dysplasia Hydrocodone W/Pap C Granuloma Phentermine C Hallucination, Auditory Lorcet Plus C Hyperinsulinism Avita (Tretinoin) C Hypoaesthesia Bromphen Dc C Increased Appetite Loestrin Fe C Infection Neurontin Influenza (Gabapentin Pfizer) C Intentional Self-Injury Buspar (Buspirone Oedema Peripheral Hydrochloride) C Pelvic Inflammatory Dyazide C Disease Axid (Nizatidine) C Prescribed Overdose Gabitril (Tiagabine Skin Lesion Hydrochloride) C Smear Cervix Abnormal Navane (Tiotixene) C Suicidal Ideation Inderal (Propranolol Suicide Attempt Hydrochloride) C Thyroid Disorder Prolixin Treatment Noncompliance (Fluphenazine Urinary Tract Infection Hydrochloride) C Weight Increased Cogentin (Benxatropine Mesilate) C Prevacid (Lansoprazole) C 24-Jun-2005 12:19 PM Page: 3649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4666330-3Report Type:Expedited (15-DaCompany Report #US_0503114459 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Zyprexa-Oral Blood Alkaline (Olanzapine) Phosphatase Increased (Olanzapine) PS 2.5 MG AT Blood Cholesterol BEDTIME Increased Lipitor Blood Triglycerides (Atorvastatin) C Increased Atenolol C Blood Urine Present Easpirin C Cataract Chlorpromazine C Condition Aggravated Accupril (Quinapril Diabetes Mellitus Hydrochloride) C Non-Insulin-Dependent Norvasc (Amlodipine) C Microalbuminuria Pyrexia Retinopathy Hypertensive Therapeutic Response Unexpected Urinary Tract Infection Urine Albumin/Creatinine Ratio Increased Vomiting Weight Decreased White Blood Cell Count Increased White Blood Cells Urine Positive Date:05/17/05ISR Number: 4666333-9Report Type:Expedited (15-DaCompany Report #US_031198945 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:05/17/05ISR Number: 4666335-2Report Type:Expedited (15-DaCompany Report #USA050393329 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemic Health Zyprexa-Oral Hyperosmolar Nonketotic Professional (Olanzapine) Syndrome Company (Olanzapine) PS 5 MG Representative Date:05/17/05ISR Number: 4666337-6Report Type:Expedited (15-DaCompany Report #USA050189378 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa-Oral Fall Professional (Olanzapine) Haemorrhage Intracranial Company (Olanzapine) PS 5 MG/1 DAY Vomiting Representative Neurontin (Gabapentin Pfizer) C Effexor (Venlafaxine Hydrochloride) C 24-Jun-2005 12:19 PM Page: 3650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro (Escitalopram Oxalate) C Date:05/17/05ISR Number: 4666566-1Report Type:Expedited (15-DaCompany Report #USA050187550 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Consumer Zyprexa-Oral Other Drug Level Increased (Olanzapine) (Olanzapine) PS 40 MG DAY Ativan (Lorazepam) C Date:05/18/05ISR Number: 4665650-6Report Type:Direct Company Report #CTU 248978 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Zyprexa 15 Mg Eli Lilly PS Eli Lilly ORAL 15 MG BEDTIME ORAL Date:05/18/05ISR Number: 4666203-6Report Type:Expedited (15-DaCompany Report #8009200 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Affective Disorder Foreign Keppra PS ORAL 1500 MG/D PO Hospitalization - Areflexia Health Keppra SS ORAL 140000 MG Initial or Prolonged Catheter Related Professional ONCE PO Complication Other Keppra SS ORAL 2000 MG /D PO Coma Keppra SS ORAL 2500 MG /D PO Condition Aggravated Zyprexa SS ORAL 10 MG /D PO Epilepsy Zyprexa SS ORAL 500 MG ONCE Haemodialysis PO Hypotension Diazepam SS ORAL ONCE PO Intentional Misuse Diazepam SS ORAL 1 MG /D PO Psychotic Disorder Lamictal SS ORAL 600 MG/ D PO Rash Schizophreniform Disorder Somnolence Suicide Attempt Tachycardia Date:05/19/05ISR Number: 4666482-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12965067 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Atenolol PS Sandoz Inc. (Geneva Other Intentional Misuse Pharm Tech) ORAL Suicidal Ideation Acetylsalicylic Acid SS ORAL Effexor Xr SS ORAL Olanzapine SS ORAL 24-Jun-2005 12:19 PM Page: 3651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/05ISR Number: 4668684-0Report Type:Expedited (15-DaCompany Report #2005071563 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Neurontin Initial or Prolonged Convulsion (Gabapentin) PS ORAL 400 MG (1D), Other Difficulty In Walking ORAL Dizziness Lamictal Drug Ineffective (Lamotrigine) SS Gait Disturbance Zyprexa (Olanzapine) SS Increased Appetite Seroquel (Quetiapine Insomnia Fumarate) SS Metabolic Disorder Depakote (Valproate Migraine Sodium) SS Suicidal Ideation Depakene (Valproate Weight Increased Sodium) C Claritin (Loratadine) C Date:05/23/05ISR Number: 4668973-XReport Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0365152A Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Lamictal PS Glaxosmithkline ORAL 6 DAY Initial or Prolonged Blood Pressure Increased Floxyfral SS ORAL 50MG Per day 3 DAY Confusional State Trittico SS ORAL 200MG Per day 3 DAY Disorientation Zyprexa SS ORAL 5MG Per day 3 DAY Hyperhidrosis Bactrim Forte C Glaxosmithkline ORAL Logorrhoea Blopress C ORAL 16MG Per day 3 DAY Date:05/23/05ISR Number: 4670715-9Report Type:Expedited (15-DaCompany Report #EWC041241963 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Olanzapine PS ORAL 20 MG Hepatic Fibrosis Health Hepatic Steatosis Professional Treatment Noncompliance Other Date:05/23/05ISR Number: 4670748-2Report Type:Expedited (15-DaCompany Report #CA_050508115 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Corneal Dystrophy Foreign Zyprexa PS ORAL 2.5 MG DAY Consumer Other Date:05/23/05ISR Number: 4672825-9Report Type:Expedited (15-DaCompany Report #200510316BNE Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Aspirin Intentional Misuse Health (Acetylsalicylic Multiple Drug Overdose Professional Acid) PS ORAL ORAL Suicidal Ideation Other Efexor Xl (Venlafaxine Hydrochloride) SS ORAL 150 MG , TOTAL DAILY, 24-Jun-2005 12:19 PM Page: 3652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Atenolol SS ORAL ORAL Olanzapine SS ORAL ORAL Date:05/23/05ISR Number: 4673660-8Report Type:Expedited (15-DaCompany Report #US_0504115258 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Zyprexa-Oral Abnormal Health (Olanzapine) Blood Triglycerides Professional (Olanzapine) PS 15 MG Increased Prozac (Fluoxetine Diabetes Mellitus Hydrochloride) C Hypoaesthesia Risperdal Hypoglycaemia (Risperidone) C Hysterectomy Wellbutrin Nerve Root Lesion (Bupropion Salpingo-Oophorectomy Hydrochloride) C Bilateral Premarin C Divalproex (Valproate Semisodium) C Desyrel (Trazodone Hydrochloride) C Bupropion C Topamax (Topiramate) C Tequin (Gatifloxacin) C Diflucan (Fluconazole) C Date:05/23/05ISR Number: 4695557-XReport Type:Expedited (15-DaCompany Report #2005GB00963 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Atenolol PS Zeneca Other Intentional Misuse Pharmaceutical ORAL Suicidal Ideation Efexor Xl SS ORAL Aspirin SS ORAL Olanzapine SS ORAL Date:05/24/05ISR Number: 4673283-0Report Type:Direct Company Report #CTU 249347 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Olanzapine PS ORAL 15 MG DAILY Intervention to Laboratory Test Abnormal ORAL 6 MON Prevent Permanent Metabolic Syndrome Ziprasidone C Impairment/Damage Clonazepam C Metformin C Date:05/24/05ISR Number: 4673840-1Report Type:Expedited (15-DaCompany Report #FR_050306000 Age:66 YR Gender:Female I/FU:F Outcome PT Hospitalization - Amnesia Initial or Prolonged Atherosclerosis Atrial Fibrillation 24-Jun-2005 12:19 PM Page: 3653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Disorder Cholelithiasis Electrocardiogram Report Source Product Role Manufacturer Route Dose Duration Abnormal Foreign Zyprexa-Oral Facial Palsy Health (Olanzapine) Hepatomegaly Professional (Olanzapine) PS 5 MG DAY Hypotonia Other Deroxat (Paroxetine Ischaemia Hydrochloride) C Transient Ischaemic Atarax (Alprazolam Attack Dum) C Ventricular Hypertrophy Kardegic (Acetylsalicylic Lysine) C Vastarel (Trimetazidine Hydrochloride) C Di-Antalvic C Cordarone (Amiodarone Hydrochloride) C Mobic (Meloxicam) C Cacit D3 C Zoltum (Omeprazole Ratiopharm) C Lactulose C Date:05/24/05ISR Number: 4673841-3Report Type:Expedited (15-DaCompany Report #EWC050242784 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zyprexa-Oral Increased Health (Olanzapine) Aspartate Professional (Olanzapine) PS 5 MG/1 DAY Aminotransferase Company Lithuril (Lithium Increased Representative Carbonate) C Asthenia Other Ativan (Lorazepam) C Blood Alkaline Phosphatase Increased Chest Pain Electrocardiogram St Segment Abnormal Haematemesis Nausea Vomiting Date:05/24/05ISR Number: 4673842-5Report Type:Expedited (15-DaCompany Report #EWC050543795 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Drug Interaction Health (Olanzapine) Drug Toxicity Professional (Olanzapine) PS 10 MG DAY Intentional Misuse Other Buprenorphine C Intentional Self-Injury Levomepromazine C Sopor Diazepam C 24-Jun-2005 12:19 PM Page: 3654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/05ISR Number: 4673844-9Report Type:Expedited (15-DaCompany Report #EWC050343214 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Zyprexa-Oral Cardiac Failure Health (Olanzapine) Cerebral Atherosclerosis Professional (Olanzapine) PS 10 MG/1 DAY Cerebral Thrombosis Company Zinacef (Cefuroxime Coma Representative Sodium) C Cystitis Other Seroquel (Quetiapine Dehydration Fumarate) C Disorientation Rivotril Dysarthria (Clonazepam) C Electrocardiogram T Wave Tegretol Abnormal (Carbamazepine Hepatotoxicity Rivopharm) C Hypertension Liver Disorder Myocardial Ischaemia Psychotic Disorder Respiratory Failure Shock Speech Disorder Date:05/24/05ISR Number: 4673845-0Report Type:Expedited (15-DaCompany Report #EWC041141519 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa-Oral Life-Threatening Blood Pressure Health (Olanzapine) Hospitalization - Orthostatic Professional (Olanzapine) PS Initial or Prolonged Dizziness Company Other Electrocardiogram T Wave Representative Inversion Other Fatigue Grand Mal Convulsion Loss Of Consciousness Oedema Peripheral Shock Date:05/24/05ISR Number: 4673851-6Report Type:Expedited (15-DaCompany Report #JP_050506552 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erythema Foreign Zyprexa-Oral Platelet Count Decreased Health (Olanzapine) White Blood Cell Count Professional (Olanzapine) PS 15 MG DAY Decreased Other Akineton (Biperiden Hydrochloride) C Date:05/24/05ISR Number: 4673883-8Report Type:Expedited (15-DaCompany Report #DE_050515876 Age:62 YR Gender:Female I/FU:I Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase Increased 24-Jun-2005 12:19 PM Page: 3655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cor Pulmonale Deep Vein Thrombosis Dyspnoea Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Foreign Zyprexa-Oral Hepatic Steatosis Health (Olanzapine) Hepatosplenomegaly Professional (Olanzapine) PS 7.5 MG DAY Oedema Peripheral Other L-Thyroxin Pulmonary Hypertension (Levothyroxine Urinary Retention Sodium) C Venous Insufficiency Aspirin Protect 100 Weight Increased (Acetylsalicylic Acid) C Locol (Fluvastatin Sodium) C Concor (Bisoprolol Fumarate) C Stilnox (Zolpidem Tartrate) C Date:05/24/05ISR Number: 4673884-XReport Type:Expedited (15-DaCompany Report #FR_050506367 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Foreign Zyprexa-Oral Abnormal Health (Olanzapine) Memory Impairment Professional (Olanzapine) PS 15 MG DAY Other Xanax (Alprazolam Dum) C Date:05/24/05ISR Number: 4673924-8Report Type:Expedited (15-DaCompany Report #GBS050517367 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Foreign Olanzapine-Oral Increased Health (Olanzapine) PS 5 MG Professional Perphenazine C Other Venlafaxine C Date:05/24/05ISR Number: 4673935-2Report Type:Expedited (15-DaCompany Report #GBS050417050 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Effect Foreign Olanzapine-Oral Health (Olanzapine) PS Professional Risperidone C Other Date:05/24/05ISR Number: 4673942-XReport Type:Expedited (15-DaCompany Report #GBS050517307 Age:36 YR Gender:Female I/FU:I Outcome PT Death Circulatory Collapse Fear Incontinence Paranoia Pulmonary Embolism Refusal Of Treatment By 24-Jun-2005 12:19 PM Page: 3656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Patient Thrombophlebitis Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS 5 MG Professional Company Representative Other Date:05/24/05ISR Number: 4673958-3Report Type:Expedited (15-DaCompany Report #US_0505117282 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disease Recurrence Foreign Cymbalta (Duloxetine Hepatic Enzyme Abnormal Health Hydrochloride) PS Hypertension Professional Zyprexa-Oral Other (Olanzapine) (Olanzapine) SS 25 MG/2 DAY Reboxetine C Synthroid (Levothyroxine Sodium) C Loxatan (Bromazepam) C Enalapril C Atensina (Clonidine Hydrochloride) C Fluoxetine (Fluoxetine) C Lamotrigine C Date:05/24/05ISR Number: 4674121-2Report Type:Direct Company Report #CTU 249438 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Zyperxa PS ORAL 15MG. DAILY Increased ORAL Hyperglycaemia Date:05/24/05ISR Number: 4674328-4Report Type:Expedited (15-DaCompany Report #US_0505117376 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Literature Zyprexa-Oral Delirium Health (Olanzapine) Diarrhoea Professional (Olanzapine) PS OTHER 5 MG OTHER Drug Effect Decreased Octreotide C Extrapyramidal Disorder Loperamide C Hallucination, Visual Lansoprazole C Myoclonus Haloperidol C Therapeutic Agent Glycopyrrolate C Toxicity Normal Saline C Codeine C 24-Jun-2005 12:19 PM Page: 3657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/05ISR Number: 4674329-6Report Type:Expedited (15-DaCompany Report #US_0505117350 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delirium Literature Zyprexa-Oral Other Hallucination, Visual Health (Olanzapine) Myoclonus Professional (Olanzapine) PS 5 MG/ 2 DAY Neurotoxicity Famotidine C Octreotide C Mirtazapine C Morphine C Ezol C Radiation Therapy C Date:05/24/05ISR Number: 4674370-3Report Type:Expedited (15-DaCompany Report #USA050597709 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa-Oral Professional (Olanzapine) (Olanzapine) PS 30 MG DAY Date:05/24/05ISR Number: 4674372-7Report Type:Expedited (15-DaCompany Report #USA050597706 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Zyprexa-Oral Initial or Prolonged Increased (Olanzapine) Other Angiogram Abnormal (Olanzapine) PS 20 MG DAY Aspartate Klonopin Aminotransferase (Clonazepam) C Increased Ativan(Lorazepam) C Drug Ineffective Neurontin(Gabapentin Electrocardiogram Pfizer) C Abnormal Aciphex(Rabeprazole Neuroleptic Malignant Sodium) C Syndrome Risperdal Pneumonia (Risperidone) C Rhabdomyolysis Trazadone (Trazdone) C Sedation Advair C Underdose Albuterol C Date:05/24/05ISR Number: 4674374-0Report Type:Expedited (15-DaCompany Report #US_0411107655 Age:45 YR Gender:Female I/FU:I Outcome PT Hospitalization - Adhesion Initial or Prolonged Blood Cholesterol Increased Blood Pressure Fluctuation Hyperphagia Hypertension Hypoglycaemia Hysterectomy Mumps Obesity Polydipsia Polytraumatism 24-Jun-2005 12:19 PM Page: 3658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polyuria Salpingo-Oophorectomy Uterine Dilation And Report Source Product Role Manufacturer Route Dose Duration Curettage Consumer Zyprexa-Oral Vision Blurred Health (Olanzapine) Professional (Olanzapine) PS 15 MG Prozac-Oral (Fluoxetine) (Fluoxetine Hydrochloride) SS Symbyax-Olanzapine/F luoxetine (Unknown Dose) (Ola SS Fluoxetine Hydrochloride C Seroquel (Quetiapine Fumarate) C Wellbutrin (Bupropion Hydrochloride) C Remeron(Mirtazapine Orifarm) C Lorazepam C Haldol (Haloperidol Decanoate) C Modafinil C Naproxen Sodium C Clonazepam C Atorvastatin C Celecoxib C Nitrobid(Nitrofurant oin) C Hydrochlorothiazide C Alprazolam C Zanaflex(Tizanidine Hydrochloride) C Ranitidine C Topamax (Topiramate) C Hydroxyzine C Metformin C Imipramine C Cenestin(Estrogens Conjugated) C Quetiapine C Date:05/24/05ISR Number: 4674376-4Report Type:Expedited (15-DaCompany Report #US_0410106308 Age:23 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Alanine Aminotransferase Other Increased Aspartate Aminotransferase Increased Blood Chloride Increased Blood Cholesterol Increased Blood Gastrin Increased Blood Triglycerides 24-Jun-2005 12:19 PM Page: 3659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Communication Disorder Contusion Convulsion Report Source Product Role Manufacturer Route Dose Duration Decreased Activity Consumer Zyprexa-Oral Depression Health (Olanzapine) Diabetes Mellitus Professional (Olanzapine) PS 7 MG/1 DAY Diabetic Coma Abilify(Aripiprazole Diabetic Ketoacidosis ) C Dyspepsia Risperidone C Electroencephalogram Haldol(Haloperidol Abnormal Decanoate) C Glycosylated Haemoglobin Tofranil-Pm(Imiprami Increased ne Embonate) C Hyperglycaemia Glipizide C Hypokinesia Actos "Takeda" Insomnia (Pioglitazone) C Laboratory Test Abnormal Clonidine C Myoclonic Epilepsy Topiramate C Nervousness Zonisamide C Pain In Extremity Atorvastatn Calcium C Pancreatitis Metformin C Photosensitivity Reaction Acetaminophen C Pollakiuria Zocor (Simvastatin Rash Ratiopharm) C Sleep Apnoea Syndrome Clonazepam C Somnolence Insulin C Thyroxine Decreased Nph Insulin (Insulin Weight Increased Injection, Isophane) C White Blood Cell Count Prevacid Decreased (Lansoprazole) C Carbamazepine C Lamotrigine C Ranitidine C Novolin N (Insulin Human Injection, Isophane) C Novolin R (Insulin Human) C Prilosec(Omeprazole) C Date:05/24/05ISR Number: 4674463-0Report Type:Expedited (15-DaCompany Report #USA050597388 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Symbyax-Olanzapine Professional 6mg / Fluxoetine Company 25mg (Olanzapine PS 5 DAY Representative Cardiac/Blood Pressure Medication C Date:05/24/05ISR Number: 4674500-3Report Type:Expedited (15-DaCompany Report #USA050597132 Age:51 YR Gender:Male I/FU:F Outcome PT Death Aortic Atherosclerosis Atherosclerosis Bladder Distension Drug Screen Positive Drug Toxicity 24-Jun-2005 12:19 PM Page: 3660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Pulmonary Congestion Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Victim Of Homicide Health Symbyax-Olanzapine 6 Professional Mg/ Fluoxetine 25 Mg (Olaznapine) PS 1 YR Zyprexa-Oral (Olanzapine) (Olanzapine) SS 20 MG Valium (Diazepam) C Fentanyl C Date:05/24/05ISR Number: 4674570-2Report Type:Expedited (15-DaCompany Report #US_0411107842 Age:31 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Alanine Aminotransferase Other Increased Appetite Disorder Arrhythmia Aspartate Aminotransferase Increased Asthenia Blood Alkaline Phosphatase Increased Blood Glucose Increased Blood Ketone Body Present Blood Potassium Decreased Blood Pressure Inadequately Controlled Chest Pain Dehydration Diabetes Mellitus Diabetic Ketoacidosis Diabetic Nephropathy Disease Recurrence Dry Mouth Erectile Dysfunction Glycosuria Haematemesis Hallucination, Auditory Impaired Self-Care Insomnia Joint Swelling Labyrinthitis Lethargy Mental Disorder Metabolic Acidosis Narcissistic Personality Disorder Polydipsia Polyuria Proteinuria Renal Failure Self Injurious Behaviour Tachycardia Tremor Ulcer Haemorrhage 24-Jun-2005 12:19 PM Page: 3661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vision Blurred Weight Decreased White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 60 MG Distributor Seroquel (Quetiapine Fumarate) C Risperdal (Risperidone) C Haldol (Haloperidol Decanoate) C Depakote (Valproate Semisodium) C Lithium C Paxil (Paroxetine Hydrochloride) C Glyburide C Metformin C Insulin C Accuretic C Mirtazapine C Lisinopril (Lisinopril) C Valsartan C Quinapril C Hydrochlorothiazide/ Triamterene C Mellaril (Thioridazine Hydrochloride) C Klonopin (Clonazepam) C Stelazine (Trifluoperazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Benadryl C Accupril (Quinapril Hydrochloride) C Diovan C Date:05/24/05ISR Number: 4674571-4Report Type:Expedited (15-DaCompany Report #US_0411107616 Age:64 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Bipolar Disorder Other Blood Creatine Phosphokinase Increased Constipation Diabetes Mellitus Gastrooesophageal Reflux Disease Hiatus Hernia Loss Of Consciousness Prescribed Overdose Psychotic Disorder 24-Jun-2005 12:19 PM Page: 3662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Arrest Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 25 MG DAY 71 WK Seroquel (Quetiapine Fumarate) C Symbyax C Apo-Divalproex (Valproate Semisodium) C Glucophage (Metformin) C Glyset (Miglitol) C Starlix (Nateglinide) C Actos (Pioglitazone Hydrochloride) C Avandia (Rosiglitazone Maleate) C Zoloft (Sertraline Hydrochloride) C Sonata (Zaleplon) C Miralax (Macrogol) C Tricor (Fenofibrate) C Altace (Ramipril Dura) C Pletal (Cilostazol) C Propranolol C Prandin (Deflazacort) C Thiothixene C Date:05/24/05ISR Number: 4674572-6Report Type:Expedited (15-DaCompany Report #USA040157139 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Consumer Zyprexa-Oral Depressed Mood Health (Olanzapine) Drug Withdrawal Syndrome Professional (Olanzapine) PS 20 MG/1 DAY Faeces Discoloured Zoloft (Sertraline Feeling Abnormal Hydrochloride) C Heart Rate Increased Paxil (Paroxetine Hepatic Enzyme Increased Hydrochloride) C Hepatic Failure Hepatomegaly Insomnia Nervousness Pancreatic Disorder Tension Weight Increased 24-Jun-2005 12:19 PM Page: 3663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/05ISR Number: 4674573-8Report Type:Expedited (15-DaCompany Report #US_0410106496 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Biliary Dilatation Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Other Gastritis Professional (Olanzapine) PS 10 MG/1 AT Hepatic Cirrhosis BEDTIME Hepatic Steatosis Olanzipine/Fluoxetin Hepatitis e Capsule C Hepatomegaly Risperdal Impaired Gastric Emptying (Risperidone) C Liver Disorder Bupropion C Citalopram Hydrobromide C Glipizide C Metformin C Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Norvasc (Amlodipine) C Atenolol C Combivent C Allegra (Fexofenadine Hydrochloride) C Cyclobenzaprine C Neurontin (Gabapentin Pfizer) C Celebrex (Celecoxib) C Promethazine C Prilosec (Omeprazole Ratiopharm) C Singulair (Montelukast) C Date:05/25/05ISR Number: 4673129-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050503162 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Thrombosis Haldol PS Initial or Prolonged Electrocardiogram St-T Haldol SS Change Bromperidol SS 6-9 mg daily Tachycardia Perospirone SS 16-36 mg daily (36 mg at the time of the event) Olanzapine SS Trihexyphenidyl SS Clonazepam SS Olanzapine SS Zotepine SS 50-200 mg daily (100 mg at the time of the event) Haldol SS 24-Jun-2005 12:19 PM Page: 3664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/05ISR Number: 4673408-7Report Type:Expedited (15-DaCompany Report #JP-ROCHE-404874 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Clonazepam PS Roche UNKNOWN Initial or Prolonged Atrial Fibrillation Haloperidol SS Roche UNKNOWN Atrial Thrombosis Clocapramine SS UNKNOWN Catatonia Zotepine SS UNKNOWN Dehydration Bromperidol SS UNKNOWN Delusion Perospirone Electrocardiogram St-T Hydrochloride Change Hydrate SS UNKNOWN Hallucination, Auditory Olanzapine SS UNKNOWN Insomnia International Normalised Ratio Decreased Palpitations Tachycardia Date:05/25/05ISR Number: 4677108-9Report Type:Direct Company Report #CTU 249568 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Olanzapine 15 Mg PS ORAL 15 MG HS Glycosylated Haemoglobin ORAL Increased Date:05/26/05ISR Number: 4675919-7Report Type:Direct Company Report #CTU 249712 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Zyprexa 2.5 Mg PS ORAL 12 MG PER Choking DAY ORAL Cough Cephlexin SS ORAL 4 TABLETS Dyspnoea PER DAY Respiratory Disorder ORAL Respiratory Tract Calcitonin Nasal Congestion Spray C Vitamins C Date:05/26/05ISR Number: 4676574-2Report Type:Expedited (15-DaCompany Report #GXKR2005GB01089 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Acetylsalicylic Acid Intentional Misuse Health (Ngx)(Acetylsalicycl Multiple Drug Overdose Professional ic Acid) PS ORAL ORAL Other Atenolol (Ngx)(Atenolol) Unknown SS ORAL ORAL Efexor Xl(Venlafaxine Hydrochloride) SS ORAL 150 MG, QD, ORAL Olanzapine(Olanzapin e) SS ORAL ORAL 24-Jun-2005 12:19 PM Page: 3665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4677185-5Report Type:Expedited (15-DaCompany Report #GBWYE681319MAY05 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Health Efexor (Venlafaxine Pregnancy Professional Hydrochloride, Gastroschisis Other Tablet) PS ORAL 150 MG, ORAL 368 DAY Olanzapine (Olanzapine, , 0) SS ORAL 10 MG, ORAL 53 DAY Temazepam (Temazepam) C Date:05/26/05ISR Number: 4677256-3Report Type:Expedited (15-DaCompany Report #DSA_25800_2005 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Temesta PS ORAL 1 MG Q DAY PO Initial or Prolonged Confusional State Health Allopurinol SS ORAL 100 MG 1 DAY Disorientation Professional PO Encephalopathy Other Plavix SS ORAL 75 MG Q DAY Hyperreflexia PO Zyprexa SS ORAL 5 MG Q DAY PO Imovane C Zocor C Date:05/26/05ISR Number: 4677259-9Report Type:Expedited (15-DaCompany Report #DSA_26422_2005 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Tavor PS ORAL 25 MG ONCE PO Initial or Prolonged Loss Of Consciousness Health Trevilor SS ORAL 3900 MG ONCE Multiple Drug Overdose Professional PO Tachycardia Other Zopiclone SS ORAL 150 MG ONCE PO Zyprexa SS ORAL 1035 MG ONCE PO Date:05/27/05ISR Number: 4676720-0Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-05P-151-0301153-00 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Cipralex Film-Coated Epilepsy Tablets PS ORAL Cipralex Film-Coated Tablets SS ORAL Olanzapine SS ORAL Midazolam SS ORAL Midazolam SS ORAL Procyclidine Hydrochloride SS ORAL Procyclidine Hydrochloride SS ORAL 24-Jun-2005 12:19 PM Page: 3666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4677710-4Report Type:Expedited (15-DaCompany Report #GBWYE681319MAY05 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congenital Anomaly Health Efexor (Venlafaxine Drug Exposure During Professional Hydrochloride, Pregnancy Other Tablet) PS TRANSPLACENTAL 150 MG, Gastroschisis TRANSPLACENTA L 368 DAY Olanzapine (Olanzapine, , 0) SS TRANSPLACENTAL 10 MG, TRANSPLACENTA L 53 DAY Temazepam (Temazepam) C Date:05/27/05ISR Number: 4678640-4Report Type:Expedited (15-DaCompany Report #T05-SWI-01891-01 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Cipralex Epilepsy Study (Escitalopram) PS ORAL 30 MG QD PO Glasgow Coma Scale Health Cipralex(Excitalopra Abnormal Professional m) SS ORAL 10 MG QD PO Loss Of Consciousness Other Zyprexa(Olanzapine) SS ORAL 5 MG QD PO Dormicum(Midazolam) SS ORAL 30 MG QD PO Dormicum(Midazolam) SS ORAL 15 MG QD PO Kemadrin9procyclidin e Hydrochloride) SS ORAL 15 MG QD PO Kemadrin(Procyclidin e Hydrochloride) SS ORAL 5 MG QD PO Date:05/31/05ISR Number: 4678909-3Report Type:Expedited (15-DaCompany Report #US_0411107547 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zyprexa-Oral Initial or Prolonged Bladder Trabeculation Health (Olanzapine) Blood Cholesterol Professional (Olanzapine) PS 5 MG Abnormal Fluoxetine Diabetes Mellitus Hydrochloride C Non-Insulin-Dependent Losartan C Haematuria Diazepam C Hyperglycaemia Hydroxyzine Hyperinsulinism Hydrochloride C Hyperlipidaemia Prednisone Nephrolithiasis (Prednisone) C Rectal Haemorrhage Paroxetine C Vision Blurred Alprazolam C Esomeprazole C Metoclopramide C Pantoprazole C Acetaminophen W/Hydrocodone C Naproxen Sodium C Loratadine C Potassium Chloride C Furosemide (Furosemide) C Ezetimibe C 24-Jun-2005 12:19 PM Page: 3667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate (Lithium Carbonate) C Date:05/31/05ISR Number: 4678940-8Report Type:Expedited (15-DaCompany Report #2005076164 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Geodon (Ziprasidone) PS 160 MG(80 MG, Initial or Prolonged Professional 2 IN 1 D) Other Company Depakote (Valproate Representative Semisodium) SS Zyprexa (Olanzapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:05/31/05ISR Number: 4678965-2Report Type:Expedited (15-DaCompany Report #A0559763A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Bupropion Professional Hydrochloride Tablet (Generic) (Bupropion Hydrochloride) PS ORAL 75 MG/ SEE IMAGE/ORAL 1 DAY Wellbutrin Xl Tablet-Extended Release (Bupropion Hydrochloride) SS ORAL SEE IMAGE/ORAL Olanzapine (Olanzapine) SS Date:05/31/05ISR Number: 4679011-7Report Type:Expedited (15-DaCompany Report #GBWYE681319MAY05 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congenital Anomaly Health Efexor (Venlafaxine Drug Exposure During Professional Hydrochloride, Pregnancy Other Tablet, 0) PS TRANSPLACENTAL 150 MG, Gastroschisis TRNASPLACENTA L 368 DAY Olanzapine SS TRANSPLACENTAL 10 MG, TRANSPLACENTA L 53 DAY Temazepam (Temazepam) C Date:05/31/05ISR Number: 4684654-0Report Type:Periodic Company Report #US_0502111958 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Zyprexa-Oral Initial or Prolonged Fatigue (Olanzapine) Suicide Attempt (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Zoloft (Sertraline Hydrochloride) C Date:06/01/05ISR Number: 4680401-7Report Type:Expedited (15-DaCompany Report #EWC050544076 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - African Trypanosomiasis Foreign Zyprexa-Oral Initial or Prolonged Constipation Consumer (Olanzapine) Diarrhoea Other (Olanzapine) PS 1 DSG FORM/1 Feeling Drunk DAY Nausea Trilafon Somnolence (Perphenazine Enantate) C Date:06/01/05ISR Number: 4680402-9Report Type:Expedited (15-DaCompany Report #EWC050544025 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Olanzapine-Oral Initial or Prolonged Confusional State Health (Olanzapine) PS 250 MG Drug Interaction Professional Methadone C Overdose Other Dormicum (Midazolam Respiratory Distress Hydrochloride) C Respiratory Failure Solian (Amisulpride) C Prazine (Promazine Hydrochloride) C Date:06/01/05ISR Number: 4680404-2Report Type:Expedited (15-DaCompany Report #FR_050506429 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cardiac Disorder Foreign Zyprexa-Oral Congenital Anomaly Health (Olanzapine) Drug Exposure During Professional (Olanzapine) PS Pregnancy Other Depakote (Valproate Rhabdomyoma Semisodium) C Tuberous Sclerosis Date:06/01/05ISR Number: 4680405-4Report Type:Expedited (15-DaCompany Report #GBS050517417 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zyprexa-Oral Initial or Prolonged Lung Disorder Health (Olanzapine) Obstruction Professional (Olanzapine) PS 10 MG DAY Pancreatitis Company Weight Decreased Representative Other 24-Jun-2005 12:19 PM Page: 3669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/05ISR Number: 4680406-6Report Type:Expedited (15-DaCompany Report #GBS050517388 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Olanzapine-Oral Other Intentional Misuse Health (Olanzapine) PS Multiple Drug Overdose Professional Efexor Xl Other (Venlafaxine Hydrochloride) C Acetlysalicylic Acid C Atenolol C Date:06/01/05ISR Number: 4680408-XReport Type:Expedited (15-DaCompany Report #JP_050506572 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Red Blood Cell Count Foreign Zyprexa-Oral Decreased Health (Olanzapine) Professional (Olanzapine) PS 20 MG DAY Other Valproate Sodium C Date:06/01/05ISR Number: 4680412-1Report Type:Expedited (15-DaCompany Report #DE_050515974 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Drug Intake By Foreign Zyprexa Velotab-Oral Initial or Prolonged Child Health (Olanzapine) Blood Prolactin Increased Professional (Olanzapine) PS 20 MG Medication Error Company Fluorette (Sodium Representative Fluoride) C Other Date:06/01/05ISR Number: 4680417-0Report Type:Expedited (15-DaCompany Report #EWC050544011 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Foreign Olanzapine-Oral Blood Calcium Increased Health (Olanzapine) PS 5 MG/1 DAY Blood Creatine Professional Venlafaxine C Phosphokinase Increased Other Mirtazapine C Lipase Increased Galantamin C Date:06/01/05ISR Number: 4680440-6Report Type:Expedited (15-DaCompany Report #JP_050406408 Age:50 YR Gender:Female I/FU:I Outcome PT Life-Threatening Abnormal Behaviour Hospitalization - Agitation Initial or Prolonged Alanine Aminotransferase Other Increased Aspartate Aminotransferase Increased Basal Ganglion Degeneration Blood Creatine Phosphokinase Increased Cardiac Disorder 24-Jun-2005 12:19 PM Page: 3670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cerebral Atrophy Cognitive Disorder Depressed Level Of Report Source Product Role Manufacturer Route Dose Duration Consciousness Foreign Zyprexa-Oral Electrocardiogram Literature (Olanzapine) Abnormal Health (Olanzapine) PS 15 MG DAY Excitability Professional Rivotril Hyperhidrosis Other (Clonazepam) C Muscle Rigidity Halcion (Triazolam) C Neuroleptic Malignant Silece Syndrome (Flunitrazepam Eg) C Parkinson'S Disease Carbidopa W/Levodopa C Pulmonary Artery Pursennid C Thrombosis Valproic Acid C Pulmonary Embolism Pyrexia Respiratory Disorder Restlessness Stereotypy Weight Decreased Weight Increased Date:06/01/05ISR Number: 4680505-9Report Type:Expedited (15-DaCompany Report #JP_050506492 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Zyprexa-Oral Other Blood Pressure Decreased Health (Olanzapine) Blood Pressure Professional (Olanzapine) PS 10 MG DAY Inadequately Controlled Other Wypax (Lorazepam) C Condition Aggravated Chlorpromazine C Depressed Level Of Lullan (Perospirone Consciousness Hydrochloride) C Heart Rate Decreased Lasix (Furosemide) C Hepatic Failure Levomepromazine C Hyperammonaemia Lithium C Immunodeficiency Phenobarbital C Mouth Breathing Flunitrazepam C Oral Intake Reduced Brotizolam C Pancytopenia Triazolam C Psychiatric Symptom Propericiazine Pyrexia (Periciazine) C Renal Failure Sepsis Date:06/01/05ISR Number: 4680940-9Report Type:Expedited (15-DaCompany Report #2005-127096-NL Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Mirtazapine PS DF Initial or Prolonged Phosphokinase Increased Amisulpride SS 400 MG Blood Pressure Olanzapine SS DF Fluctuation Citalopram SS DF Extrapyramidal Disorder Zopiclone SS DF Malaise Parkinsonism Pyrexia Weight Decreased 24-Jun-2005 12:19 PM Page: 3671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/05ISR Number: 4681426-8Report Type:Expedited (15-DaCompany Report #USA050598267 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa-Oral Professional (Olanzapine) Company (Olanzapine) PS 25 MG DAY Representative Date:06/01/05ISR Number: 4681427-XReport Type:Expedited (15-DaCompany Report #US_0410106494 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Zyprexa-Oral Initial or Prolonged Increased (Olanzapine) Other Anaemia (Olanzapine) PS Aspartate Olanzipine/Fluoxetin Aminotransferase e Capsule C Increased Quetiapine C Blood Glucose Increased Zoloft (Sertraline Haemoglobin Decreased Hydrochloride) C Hepatic Enzyme Increased Spironolactone C Pancreatitis Acute Esomeprazole C Staphylococcal Catapres C Bacteraemia Hydroxzine C Subclavian Vein Promethazine C Thrombosis Clarinex Unevaluable Event (Desloratadine) C Hydromorphone C Niferex (Polysaccharide-Iron Complex) C B12 (Cynanocobalamin-Tan nin Complex) C Date:06/01/05ISR Number: 4681428-1Report Type:Expedited (15-DaCompany Report #US_0408105021 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Acetonaemia Initial or Prolonged Diabetes Mellitus Non-Insulin-Dependent Diabetic Ketoacidosis Hangover Hyperglycaemia Hypertension Hypokalaemia Impaired Self-Care Increased Appetite Influenza Ketonuria Mental Disorder Metabolic Syndrome Multiple Drug Overdose Obesity Pancreatitis Phimosis Sedation Suicidal Ideation 24-Jun-2005 12:19 PM Page: 3672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Thinking Abnormal Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 50 MG AT BEDTIME Wellbutrin (Bupropion Hydrochloride) C Tofranil (Imipramine Hydrochloride) C Remeron (Mirtazapine Orifarm) C Serzone (Nefazodone Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Tenormin (Atenolol Eg) C Metoprolol C Klonopin (Clonazepam) C Nadaolol C Seroquel (Quetiapine Fumarate) C Risperdal (Risperidone) C Geodon (Ziprasidone Hydrochloride) C Eskalith (Lithium Carbonate) C Unspecified Beta Blockers C Ambien (Zolpidem Tartrate) C Trazadone (Trazadone) C Buspar (Buspirone Hydrochloride) C Amiloride Hcl W/Hydrochlorothiazid e C Anafranil (Clomipramine Hydrochloride) C Navane (Tiotixine) C Lipitor (Atorvastatin Calcium) C Cytomel (Liothyronine Sodium) C Ativan (Lorazepam) C Buspar (Buspirone Hydrochloride) C Lithium C 24-Jun-2005 12:19 PM Page: 3673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin (Gabapentin Pfizer) C Haladol (Haloperidol Decanoate) C Simvastatin C Glucophage (Metformin /00082701/) C Metamucil /00091301 / (Psyllium Hydrophilic Mucilloid) C Date:06/01/05ISR Number: 4681460-8Report Type:Expedited (15-DaCompany Report #US_0411107624 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacteraemia Consumer Zyprexa-Oral Initial or Prolonged Blood Glucose Increased Health (Olanzapine) Blood Triglycerides Professional (Olanzapine) PS 20 MG Increased Tenormin(Atenolol Condition Aggravated Eg) C Hypothyroidism Inderal(Propranolol Pyelonephritis Hydrochloride) C Tardive Dyskinesia Seroquel (Quetiapine Treatment Noncompliance Fumarate) C Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Symbyax C Glyburide C Topamax (Topiramate) C Synthroid (Levorhyroxine Sodium) C Naprosyn (Naproxen Mepha) C Glucophage (Metformin) C Rofecoxib C Flurazepam C Chlordiazepoxide C Tolterodine C Furosemide (Furosemide) C Donepezil C Glyburide C Trihexyphenidyl C Valsartan C Hydrochlorothiazide C Hydroxyzine C Paroxetine C Detrol La (Tolterodine L-Tartrate) C 24-Jun-2005 12:19 PM Page: 3674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/05ISR Number: 4681480-3Report Type:Expedited (15-DaCompany Report #US_0411108239 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Zyprexa-Oral Initial or Prolonged Diabetes Mellitus Health (Olanzapine) Other Insulin-Dependent Professional (Olanzapine) PS 10 MG Diabetic Ketoacidosis Hypokalaemia Leukocytosis Obesity Date:06/01/05ISR Number: 4681481-5Report Type:Expedited (15-DaCompany Report #US_0411107536 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Zyprexa-Oral Increased Health (Olanzapine) Cardiac Disorder Professional (Olanzapine) PS 10 MG Depression Lorazepam C Hypertension Serzone (Nefazodone Mental Disorder Hydrochloride) C Skin Cancer Celexa (Citalopram Hydrobromide) C Lexapro (Escitalopram Oxalate) C Diovan C Atenolol C Hydrochlorothiazide C Zetia (Ezetimibe) C Date:06/01/05ISR Number: 4681482-7Report Type:Expedited (15-DaCompany Report #US_0505117452 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Consumer Zyprexa-Oral Other (Olanzapine) (Olanzapine) PS Date:06/01/05ISR Number: 4681483-9Report Type:Expedited (15-DaCompany Report #US_0505117451 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Diabetic Coma (Olanzapine) Ketoacidosis (Olanzapine) PS Pancreatitis Date:06/01/05ISR Number: 4681484-0Report Type:Expedited (15-DaCompany Report #US_0505117679 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/05ISR Number: 4681485-2Report Type:Expedited (15-DaCompany Report #US_0505117716 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:06/01/05ISR Number: 4681486-4Report Type:Expedited (15-DaCompany Report #US_0505117678 Age:78 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:06/01/05ISR Number: 4681487-6Report Type:Expedited (15-DaCompany Report #US_0505117675 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS Date:06/01/05ISR Number: 4681794-7Report Type:Expedited (15-DaCompany Report #US_0505117461 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Literature Zyprexa-Oral Other Increased Health (Olanzapine) PS 30 MG DAY Blood Pressure Increased Professional Blood Triglycerides Increased Circulatory Collapse Delusion Diabetes Mellitus Non-Insulin-Dependent Difficulty In Walking Extrapyramidal Disorder Impaired Self-Care Low Density Lipoprotein Increased Metabolic Syndrome Mobility Decreased Psychotic Disorder Salivary Hypersecretion Schizophrenia, Paranoid Type Sedation Sleep Apnoea Syndrome Therapeutic Response Decreased Treatment Noncompliance Weight Increased 24-Jun-2005 12:19 PM Page: 3676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/05ISR Number: 4681795-9Report Type:Expedited (15-DaCompany Report #USA021225324 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Consumer Zyprexa-Oral Initial or Prolonged Abnormal Behaviour (Olanzapine) PS 2.5 MG/D IN Aggression THE MORNING Candidiasis Dental Caries Fall Fracture Gastrooesophageal Reflux Disease Nystagmus Pain Painful Erection Self Injurious Behaviour Somnolence Tooth Loss Ulcer Victim Of Child Abuse Vision Blurred Date:06/01/05ISR Number: 4681796-0Report Type:Expedited (15-DaCompany Report #USA050598294 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Consumer Zyprexa-Oral Hospitalization - Cardiac Disorder (Olanzapine) PS 10 MG DAY Initial or Prolonged Cerebrovascular Accident Fall Lower Limb Fracture Date:06/02/05ISR Number: 4679362-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0560600A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Misuse Eskalith PS Glaxosmithkline ORAL 300MG Per day Hospitalization - Zyprexa SS Initial or Prolonged Beer SS Other Date:06/02/05ISR Number: 4680407-8Report Type:Expedited (15-DaCompany Report #GBS050517421 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Foreign Zyprexa-Oral Health (Olanzapine) Professional (Olanzapine) PS 5 MG Other Date:06/02/05ISR Number: 4681497-9Report Type:Expedited (15-DaCompany Report #US_0410106496 Age:43 YR Gender:Female I/FU:F Outcome PT Hospitalization - Biliary Dilatation Initial or Prolonged Dehydration Other Diabetes Mellitus 24-Jun-2005 12:19 PM Page: 3677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Gastritis Headache Report Source Product Role Manufacturer Route Dose Duration Hepatic Cirrhosis Consumer Zyprexa-Oral Hepatic Steatosis Health (Olanzapine) Hepatitis Professional (Olanzapine) PS 10 MG/1 AT Hepatomegaly BEDTIME Hyperkalaemia Olanzipine/Fluoxetin Hypothyroidism e Capsule C Impaired Gastric Emptying Risperdal Osteoarthritis (Risperidone) C Ovarian Disorder Bupropion C Renal Failure Acute Citalopram C Splenomegaly Hydrobromide C Thrombocytopenia Glipizide C Metformin C Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Norvasc (Amlodipine) C Atenolol C Combivent C Allegra (Fexofenadine Hydrochloride) C Cyclobenzaprine C Neurontin (Gabapentin Pfizer) C Celebrex (Celecoxib) C Promethazine C Prilosec (Omeprazole Ratiopharm) C Singulair (Montelukast) C Date:06/02/05ISR Number: 4681498-0Report Type:Expedited (15-DaCompany Report #US_0411108016 Age:13 YR Gender:Female I/FU:F Outcome PT Hospitalization - Akathisia Initial or Prolonged Bipolar Disorder Blood Glucose Increased Decreased Appetite Depression Diarrhoea Disorientation Disturbance In Attention Electroencephalogram Abnormal Excoriation Extrapyramidal Disorder Feeling Abnormal Feeling Guilty Flat Affect Hallucination Hallucinations, Mixed Influenza Like Illness Iron Deficiency Anaemia 24-Jun-2005 12:19 PM Page: 3678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharyngitis Polydipsia Polyuria Report Source Product Role Manufacturer Route Dose Duration Self-Injurious Ideation Consumer Zyprexa-Oral Suicidal Ideation Health (Olanzapine) Suicide Attempt Professional (Olanzapine) PS 30 MG AT Upper Respiratory Tract BEDTIME Infection Humulin N (Insulin Vision Blurred Human Injection, Weight Increased Isophane) C Lamotrigine C Escitalopram C Ferrous Sulfate C Diphenhydramine C Lithium Carbonate C Quetiapine C Risperidone C Abilify (Aripiprazole) C Mirtazapine C Date:06/02/05ISR Number: 4681609-7Report Type:Expedited (15-DaCompany Report #US_0411107895 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Consumer Zyprexa-Oral Other Diabetic Ketoacidosis Health (Olanzapine) Injury Professional (Olanzapine) PS 20 MG Fluoxetine (Fluoxetine) C Seroquel (Quetiapine Fumarate) C Haldol (Haloperidol Decanoate) C Depakote (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Prednisonlone C Clonazepam C Benztropine C Fluocinolone Acetonide C Zytrec (Cetirizine Hydrochloride) C Risperdal (Risperidone) C Dohenhydramine C Sulfamethoxazole C Prometrium (Progesterone) C Date:06/02/05ISR Number: 4681610-3Report Type:Expedited (15-DaCompany Report #US_0502113289 Age:34 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 24-Jun-2005 12:19 PM Page: 3679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Alcoholic Pancreatitis Consumer Zyprexa-Oral Cholelithiasis Health (Olanzapine) Ileus Professional (Olanzapine) PS Intestinal Obstruction Xanax (Alprazolam Lung Infiltration Dum) C Pancreatic Necrosis Paxil (Paroxetine Pancreatitis Hydrochloride) C Pancreatitis Acute Remeron (Mirtazapine Small Intestinal Orifarm) C Obstruction Date:06/02/05ISR Number: 4681611-5Report Type:Expedited (15-DaCompany Report #US_0411107732 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Replacement Consumer Zyprexa-Oral Hospitalization - Blood Cholesterol (Olanzapine) Initial or Prolonged Abnormal (Olanzapine) PS 7.5 MG Cardiac Failure Effexor (Venlafaxine Congestive Hydrochloride0 C Diabetes Mellitus Zoloft (Sertraline Haemorrhage Hydrochloride) C Hypertension Major Depression Pneumonia Polydipsia Polyuria Date:06/02/05ISR Number: 4681680-2Report Type:Expedited (15-DaCompany Report #US_0411107605 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Zyprexa-Oral Initial or Prolonged Abnormal Health (Olanzapine) Other Blood Creatine Professional (Olanzapine) PS 10 MG AT Phosphokinase Increased BEDTIME Blood Glucose Increased Symbyax-Olanzapine / Blood Triglycerides Fluoxetine (Ola SS Increased Bupropion C Cardiac Failure Glipizide C Congestive Metformin C Cardiomegaly Allegra-D C Diabetes Mellitus Premarin C Non-Insulin-Dependent Nexium (Esomeprazole Glycosuria Magnesium) C Glycosylated Haemoglobin Lipitor Increased (Atorvastatin Haematuria Calcium) C Hypotension Tolterodine Knee Arthroplasty L-Tartrate C Obesity Vioxx (Rofecoxib) C Oral Intake Reduced Multivitamin C Pneumonia Prozac (Fluoxetine Renal Failure Acute Hydrochloride) C Urinary Tract Infection Aspirin (Acetylsalicylic 24-Jun-2005 12:19 PM Page: 3680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid) C Zocor (Simvastatin Ratiopharm) C Prevacid (Lansoprazole) C Cyclobenzaprine C Oscal (Calcium Carbonate) C Vitamin C C Claritin (Loratadine) C Sudafed (Pseudoephedrine Hydrochloride) C Ancef (Cefazolin Sodium) C Promethazine C Calcium C Hydrocodone C Fluticasone C Trazadone (Trazodone) C Acetaminophen W/Hydrocodone C Pseudoephedrine C Date:06/02/05ISR Number: 4681872-2Report Type:Expedited (15-DaCompany Report #DE_050515876 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cor Pulmonale Foreign Zyprexa-Oral Hospitalization - Deep Vein Thrombosis Health (Olanzapine) Initial or Prolonged Fluid Retention Professional (Olanzapine) PS 7.5 MG DAY Hepatosplenomegaly Other L-Thyroxin Joint Swelling (Levothyroxine Oedema Sodium) C Pulmonary Hypertension Aspirin Protect 100 Treatment Noncompliance (Acetylsalicylic Urinary Retention Acid) C Vascular Insufficiency Locol (Fluvastatin Weight Increased Sodium) C Concor (Bisoprolol Fumarate) C Stilnox (Zolpidem Tartrate) C Date:06/02/05ISR Number: 4681929-6Report Type:Expedited (15-DaCompany Report #JP_050406288 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Foreign Zyprexa-Oral Hospitalization - Pneumonia Aspiration Study (Olanzapine) Initial or Prolonged Prescribed Overdose Health (Olanzapine) PS 25 MG DAY Professional Halomonth Other (Aloperidol Decanoate) C Akiriden (Biperiden Hydrochloride) C Flunitrazepam C 24-Jun-2005 12:19 PM Page: 3681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/05ISR Number: 4681930-2Report Type:Expedited (15-DaCompany Report #JP_050406286 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Foreign Zyprexa-Oral Malignant Neoplasm Study (Olanzapine) Progression Health (Olanzapine) PS 20 MG DAY Metastases To Bone Professional Lullan (Perospirone Other Hydrochloride) C Akiriden (Biperiden Hydrochloride) C Vegetamin B C Date:06/02/05ISR Number: 4681950-8Report Type:Expedited (15-DaCompany Report #DEWYE705731MAY05 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Trevilor Initial or Prolonged Intentional Misuse Health (Venlafaxine Overdose Professional Hydrochloride, Tablet, 0) PS ORAL MAXIMUM OF 7500 MG ORAL 1 DAY Atosil (Isopromethazine Hydrochloride, , 0) SS ORAL MAXIMUM OF 150 MG ORAL 1 DAY Benzodiazepine (Benzodiazepine, , 0) SS ORAL ORAL 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL MAXIMUM OF 1200 MG ORAL 1 DAY Date:06/02/05ISR Number: 4682424-0Report Type:Direct Company Report #CTU 250151 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemic Zyprexa 20 Mg -Lilly PS Lilly ORAL 20 MG PO Q HS Initial or Prolonged Hyperosmolar Nonketotic Neurontin C Required Syndrome Multivitamin C Intervention to Lethargy Zoloft C Prevent Permanent Thiamine C Impairment/Damage Trazodone C Folic Acid C Date:06/06/05ISR Number: 4684910-6Report Type:Direct Company Report #CTU 250483 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthralgia Risperdal 0.5 Mg PS ONCE EVERY 2 Other Dehydration WKS IN MY HIP Gingival Disorder Zyprexa Unknown SS ORAL MOUTH AND Hair Disorder DAILY Hypoaesthesia Insomnia Nail Disorder Skin Disorder 24-Jun-2005 12:19 PM Page: 3682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/05ISR Number: 4686435-0Report Type:Expedited (15-DaCompany Report #FR_050506488 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Generalised Oedema Foreign Zyprexa-Oral Initial or Prolonged Hypertensive Crisis Health (Olanzapine) Hypokalaemia Professional (Olanzapine) PS 7.5 MG/1 DAY Weight Increased Other Laroxyl (Amitriptyline Hydrochloride) C Date:06/06/05ISR Number: 4686456-8Report Type:Expedited (15-DaCompany Report #GBS050517458 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa-Oral Initial or Prolonged Drug Ineffective Health (Olanzapine) Other Neutrophil Count Professional (Olanzapine) PS 10 MG Decreased Company Schizophrenia Representative Other Date:06/06/05ISR Number: 4686457-XReport Type:Expedited (15-DaCompany Report #EWC050544183 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Zyprexa-Oral Initial or Prolonged Myocardial Infarction Health (Olanzapne) Professional (Olanzapine) PS 15 MG Company Thromb Ass Representative (Acetylsalicylic Other Acid) C Pantoloc (Pantoprazole Sodium) C Tritace (Ramipril /00885601/) C Cor /Gfr/(Bisoprolol /00802601/) C Aldactone (Spironolactone) C Lasix (Furosemide /00032601/) C Neurolepsin C Alna Retard C Date:06/06/05ISR Number: 4686665-8Report Type:Expedited (15-DaCompany Report #EWC050544136 Age:49 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Other Aspartate Aminotransferase Increased Cerebrovascular Accident Glycosuria Hyponatraemia 24-Jun-2005 12:19 PM Page: 3683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Report Source Product Role Manufacturer Route Dose Duration Foreign Olanzapine-Oral Health (Olanzapine) PS 20 MG DAY Professional Trazodone C Other Paxil (Paroxetine Hydrochloride) C Risperidone C Date:06/06/05ISR Number: 4686686-5Report Type:Expedited (15-DaCompany Report #JP_050406296 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Zyprexa-Oral Initial or Prolonged Insomnia Health (Olanzapine) Intentional Misuse Professional (Olanzapine) PS 60 MG Overdose Company Pneumonia Aspiration Representative Pyrexia Other Tardive Dyskinesia Urinary Retention Date:06/06/05ISR Number: 4686688-9Report Type:Expedited (15-DaCompany Report #GBS050517465 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Foreign Olanzapine-Oral Pregnancy Health (Olanzapine) PS Premature Baby Professional Trisomy 21 Other Date:06/06/05ISR Number: 4686768-8Report Type:Expedited (15-DaCompany Report #AU_050508605 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa-Rapid-Acting Health Im (Olanzapine) PS OTHER 10 MG OTHER Professional Chlorpromazine C Company Benzodiazepine C Representative Date:06/06/05ISR Number: 4686932-8Report Type:Expedited (15-DaCompany Report #FR_050306133 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cytolytic Hepatitis Foreign Zyprexa-Dispersible Initial or Prolonged Self Mutilation Health (Olanzapine) Professional (Olanzapine) PS 20 MG/1 DAY Company Tercian Representative (Cyamemazine) C Other Zoloft (Sertraline Hydrochloride) C Xanax (Alprazolam) C Tranxene (Clorazepate Dipotassium) C 24-Jun-2005 12:19 PM Page: 3684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Imovane (Zoplicone) C Date:06/06/05ISR Number: 4686936-5Report Type:Expedited (15-DaCompany Report #EWC041141519 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Zyprexa-Oral Life-Threatening Electrocardiogram T Wave Health (Olanzapine) Hospitalization - Inversion Professional (Olanzapine) PS Initial or Prolonged General Physical Health Company Other Deterioration Representative Grand Mal Convulsion Other Hypotension Loss Of Consciousness Oedema Peripheral Peripheral Circulatory Failure Date:06/06/05ISR Number: 4687026-8Report Type:Expedited (15-DaCompany Report #FR_050506501 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa-Oral Overdose Health (Olanzapine) Professional (Olanzapine) PS Other Date:06/07/05ISR Number: 4683899-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-402844 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Xenical PS Roche ORAL Psychotic Disorder Acamprosate C Schizoaffective Disorder Disulfiram C Zopiclone C ONE AT NIGHT. Thiamine C Trazodone C Vitamin B Complex C Epilim Chrono C ONE IN THE MORNING, TWO ON UNSPECIFIED TIME. Amisulpride I UNKNOWN Olanzapine I UNKNOWN ONE EVERY NIGHT. Date:06/07/05ISR Number: 4687064-5Report Type:Expedited (15-DaCompany Report #US_0505117936 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zyprexa-Oral (Olanzapine) (Olanzapine) PS 24-Jun-2005 12:19 PM Page: 3685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/05ISR Number: 4687066-9Report Type:Expedited (15-DaCompany Report #USA050598934 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Exposure During Health Zyprexa-Oral Pregnancy Professional (Olanzapine) Intra-Uterine Death Company (Olanzapine) PS Pregnancy Representative Date:06/07/05ISR Number: 4687091-8Report Type:Expedited (15-DaCompany Report #US_0502111719 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Consumer Zyprexa-Oral Initial or Prolonged Anxiety Health (Olanzapine) Other Blood Cholesterol Professional (Olanzapine) PS 7.5 MG Abnormal Depakote (Valproate Chest Pain Semisodium) C Confusional State Clozaril (Clozapine) C Coronary Artery Seroquel (Quetiapine Atherosclerosis Fumarate) C Diabetes Mellitus Risperdal Non-Insulin-Dependent (Risperidone) C Electrocardiogram St Paxil (Paroxetine Segment Elevation Hydrochloride) C Hyperlipidaemia Effexor (Venlafaxine Hypertension Hydrochloride) C Hypotension Glipizide /Metformin C Lipase Increased Avandia Loss Of Consciousness (Rosiglitazone Myocardial Infarction Maleate) C Renal Failure Acute Topamax (Topiramate) C Subarachnoid Haemorrhage Aspirin Tremor (Acetylsalicylic Vascular Dementia Acid) C Pantoprazole C Clonazepam C Donepezil C Deltasone (Prednisone /00044701/) C Fenofibrate C Glucotrol (Glipizide) C Simvastatin C Fentanyl C Date:06/07/05ISR Number: 4687092-XReport Type:Expedited (15-DaCompany Report #US_0411107545 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Arthritis Initial or Prolonged Back Pain Other Cardiac Failure Congestive Crying Diabetes Mellitus Diabetic Coma Dysuria Hypertension 24-Jun-2005 12:19 PM Page: 3686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Mania Obesity Report Source Product Role Manufacturer Route Dose Duration Pain Consumer Zyprexa-Oral Urinary Incontinence Health (Olanzapine) Professional (Olanzapine) PS 7.5 MG Actos (Pioglitazone Hydrochloride) C Divalproex Sodium C Glyburide C Insulin C Date:06/08/05ISR Number: 4686747-0Report Type:Expedited (15-DaCompany Report #T05-SWI-01891-01 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Cipralex Epilepsy Study (Escitalopram) PS ORAL 30 MG QD PO Loss Of Consciousness Health Cipralex Muscle Twitching Professional (Escitalopram) SS ORAL 10 MG QD PO Overdose Other Zyprexa (Olanzapine) SS ORAL 5 MG QD PO Dormicum (Midazolam) SS ORAL 30 MG QD PO Dormicum (Midazolam) SS ORAL 14 MG QD PO Kemadrin (Procyclidine Hydrochloride) SS ORAL 15 MG QD PO Kemadrin (Procyclidine Hydrochloride) SS ORAL 5 MG QD PO Date:06/09/05ISR Number: 4686493-3Report Type:Expedited (15-DaCompany Report #PHRM2005FR01731 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Tegretol PS Novartis Sector: Hospitalization - Distress Syndrome Pharma ORAL 400 mg, TID 87 DAY Initial or Prolonged Asthenia Zyprexa SS ORAL 10 mg, BID 163 DAY Blood Glucose Increased Parkinane SS ORAL 5 mg, BID 733 DAY Blood Osmolarity Loxapac SS ORAL 200 mg, TID 729 DAY Increased Loxapac SS INTRAMUSCULAR 1 DF, PRN Diabetic Coma Rivotril SS ORAL 1 mg, TID 323 DAY Diffuse Alveolar Damage Theralene SS ORAL 30 mg, PRN Haemodynamic Instability Hypothermia Loss Of Consciousness Metabolic Acidosis Neurological Symptom Oxygen Saturation Decreased Pneumonia Aspiration Renal Failure Somnolence Urine Ketone Body Present Vomiting 24-Jun-2005 12:19 PM Page: 3687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/05ISR Number: 4687472-2Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-02P-008-0200591-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Epilim Tablets PS ORAL Hospitalization - Condition Aggravated Epilim Tablets SS ORAL Initial or Prolonged Delirium Epilim Tablets SS Hallucination, Auditory Olanzapine SS ORAL Intentional Misuse Olanzapine SS ORAL Loss Of Consciousness Haloperidol SS ORAL Multiple Drug Overdose Haloperidol SS ORAL Suicide Attempt Trifeme C ORAL Bekunis C ORAL Date:06/10/05ISR Number: 4688057-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-406177 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Rivotril PS Roche ORAL Aggression Zyprexa SS ORAL Physical Assault Date:06/13/05ISR Number: 4688569-3Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-05P-151-0301153-00 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Cipralex Film-Coated Epilepsy Tablets PS ORAL Loss Of Consciousness Cipralex Film-Coated Overdose Tablets SS ORAL Olanzapine SS ORAL Midazolam SS ORAL Midazolam SS ORAL Procyclidine Hydrochloride SS ORAL Procyclidine Hydrochloride SS ORAL Date:06/13/05ISR Number: 4688940-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-406563 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Rivotril PS Roche ORAL 323 DAY Distress Syndrome Loxapac SS INTRAMUSCULAR Dehydration Loxapac SS ORAL 729 DAY Diabetic Coma Parkinane SS ORAL 733 DAY Metabolic Acidosis Zyprexa SS ORAL 163 DAY Nervous System Disorder Tegretol SS ORAL 87 DAY Renal Failure Theralene C Date:06/21/05ISR Number: 4695859-7Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200500181 Age:85 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aphasia Blood Alkaline Phosphatase Increased 24-Jun-2005 12:19 PM Page: 3688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report C-Reactive Protein Increased Cerebral Atrophy Report Source Product Role Manufacturer Route Dose Duration Csf Protein Increased Plavix PS ORAL Disorientation Temesta SS ORAL Encephalopathy Allopurinol SS ORAL Hallucination, Visual Zyprexa SS ORAL Hyperreflexia Stromectol SS ORAL UNK Myoclonus Imovane C ORAL UNK Pyrexia Zocor C ORAL UNK Date:06/22/05ISR Number: 4697524-9Report Type:Expedited (15-DaCompany Report #FR-MERCK-0506FRA00077 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Stromectol PS Merck & Co., Inc ORAL Initial or Prolonged Myoclonus Lorazepam SS ORAL Allopurinol SS ORAL Olanzapine SS ORAL Clopidogrel Bisulfate SS ORAL 24-Jun-2005 12:19 PM Page: 3689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Summary report for FOI selections: Selection by inexact search of active ingredient: OLANZAPINE% Selection by inexact search of Tradename/Verbatim: ZYPREXA% Total number of reports: 15,616 From: 01-NOV-1997 To: Present 24-Jun-2005 12:19 PM Page: 3690