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