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