FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/00ISR Number: 3538376-XReport Type:Expedited (15-DaCompany Report #10437333 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Study Aripiprazole PS ORAL ORAL Dysphagia Health Diabeta (Glyburide) SS Posture Abnormal Professional Transient Ischaemic Attack Tremor Date:12/26/00ISR Number: 3638778-7Report Type:Expedited (15-DaCompany Report #10650133 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Glucophage PS Bristol Myers Squibb Initial or Prolonged Congestive Health Co Pharmaceutical Hyperglycaemia Professional Research Institute ORAL Localised Infection Aripiprazole SS ORAL 15MG, 1/1 DAY ORAL Glipizide SS Zestril(Lisinopril) SS ORAL ORAL Cardizem (Diltiazem Hcl) SS Insulin SS Date:01/12/01ISR Number: 3647302-4Report Type:Expedited (15-DaCompany Report #10650133 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Glucophage Initial or Prolonged Localised Infection Health (Metformin Hcl) PS 500 Professional MILLIGGRAM, DAY Aripiprazole SS Bristol Myers Squibb Co Pharmaceutical Research Institute ORAL 15 MILLIGRAM, 1/1 DAY ORAL Zestril (Lisinopril) SS ORAL 5 MILLIGRAM, DAY ORAL Insulin Regular SS 10 , Cardizem Cd (Diltiazem Hcl) SS 180 MILLIGGRAM, DAY Glipizide SS 10 MIILLIGRAM , DAY Date:03/14/02ISR Number: 3882494-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11709268 Age:82 YR Gender:Female I/FU:F Outcome PT Death Acute Myocardial Infarction Atherosclerosis Coma 22-Feb-2006 08:31 AM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Increased Ecchymosis Extensor Plantar Response Report Source Product Role Manufacturer Route Dose Duration Haemorrhagic Stroke Health Blinded: International Normalised Professional Aripiprazole PS ORAL Ratio Increased Coumadin SS Bristol-Myers Squibb Pupil Fixed Company Lasix C Potassium Chloride C Apothecon Imdur C Vasotec C Multivitamin C Protonix C Keflex C Date:08/27/02ISR Number: 3968208-7Report Type:Direct Company Report #CTU 175200 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Omeprazole (Prilosec By Astrazeneca) PS Astrazeneca Aripiprazole (Abilitat By Bristol-Myers Squibb) SS Bristol-Myers Squibb Date:08/28/02ISR Number: 3967081-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12001699 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Trazodone Hcl PS Apothecon Other Blood Sodium Abnormal Aripiprazole SS ORAL Lethargy Roxanol SS Pco2 Abnormal Duragesic Patch SS Pneumonitis Dulcolax Pyrexia Suppositories C Evac-U-Gen C Tylenol Extra Strength C Prochlorperazine C Bisacodyl C Acetaminophen C Levoxyl C Potassium Chloride C Apothecon Furosemide C Protonix C Vitamin B12 C Effexor Xr C Carafate C Senokot C Prevacid C Sorbitol C Triamcinolone C Apothecon 22-Feb-2006 08:31 AM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/02ISR Number: 4025708-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12135786 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Aripiprazole PS Otsuka Initial or Prolonged Schizoaffective Disorder Professional Pharmaceutical Company, Ltd. ORAL Wellbutrin SS Prozac SS Topamax C Klonopin C Date:12/30/02ISR Number: 4032233-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12139192 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Blinded: Initial or Prolonged Humerus Fracture Professional Aripiprazole PS Otsuka Other Pharmaceutical Company, Ltd. ORAL dose decreased - date not reported Tylenol + Codeine No. 3 SS Date:01/03/03ISR Number: 4035060-3Report Type:Direct Company Report #CTU 183728 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Oedema Abilify / Aripiprazole 15mgs Otsuka PS Otsuka ORAL 15MGS 2 TABS ORAL Date:01/16/03ISR Number: 4042530-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151007 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anoxic Encephalopathy Abilify Tabs 15 Mg PS Otsuka Hospitalization - Coma Pharmaceutical Initial or Prolonged Dizziness Company, Ltd. ORAL Loss Of Consciousness Celexa C Muscle Rigidity Ativan C Pyrexia Risperidone C Renal Failure Flexeril C Rhabdomyolysis Effexor C Amitriptyline C Insulin C Ace Inhibitor C Date:01/16/03ISR Number: 4042777-3Report Type:Direct Company Report #CTU 184662 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Neck Pain Initial or Prolonged Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Report Source Product Role Manufacturer Route Dose Duration Abilify 15 Mg Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 15 MG AT BEDTIM ORAL Date:01/17/03ISR Number: 4043051-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12152492 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Abilify Tabs 15 Mg PS Otsuka Hospitalization - Coma Pharmaceutical Initial or Prolonged Drug Toxicity Company, Ltd. ORAL Disability Encephalopathy Hyperammonaemia International Normalised Ratio Decreased Date:01/24/03ISR Number: 4045588-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12158234 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Aripiprazole PS Otsuka Initial or Prolonged Hallucination, Auditory Pharmaceutical Paranoia Company, Ltd. ORAL Ativan C Date:01/27/03ISR Number: 4047197-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12159612 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Mania Pharmaceutical Psychotic Disorder Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Haldol C ORAL 1mg PRN 6 hrs for agitation Date:01/27/03ISR Number: 4047198-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12159596 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Delusion Pharmaceutical Hostility Company, Ltd. ORAL Paranoia Seroquel C ORAL Start date Weight Decreased not reported; decreased to 100 mg from 18 Dec 02 to 22-Feb-2006 08:31 AM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/03ISR Number: 4048124-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12161220 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Serzone C Bristol-Myers Squibb Company Colace C Reglan C Vistaril C Trazodone Hcl Tabs C Apothecon Depo-Provera C Protonix C Multivitamin C Calcium + Vitamin D C Date:01/29/03ISR Number: 4048635-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12161519 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL actual dosage and dates not specified/had a bottle of this dosage. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Had samples of this dosage. Geodon C Depakote C Lithium C Ativan C Date:01/31/03ISR Number: 4050043-5Report Type:Direct Company Report #CTU 185694 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Abilify - Aripiprazole - 10mg Bristol Myers Squib PS Bristol Myers Squib ORAL 10MG DAILY ORAL Date:02/06/03ISR Number: 4051646-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151007 Age:25 YR Gender:Male I/FU:F Outcome PT Life-Threatening Anoxic Encephalopathy Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Brain Hypoxia 22-Feb-2006 08:31 AM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Coma Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Abilify Tabs 15 Mg PS Otsuka Pyrexia Pharmaceutical Renal Failure Company, Ltd. ORAL Rhabdomyolysis Celexa C Ativan C Risperidone C Flexeril C Effexor C Amitriptyline C Insulin C Ace Inhibitor C Date:02/06/03ISR Number: 4051667-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12152492 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Abilify Tabs 15 Mg PS Otsuka Hospitalization - Aspartate Pharmaceutical Initial or Prolonged Aminotransferase Company, Ltd. ORAL 1 MON Disability Decreased Blood Glucose Increased Coma Drug Screen Positive Drug Toxicity Encephalopathy Hyperammonaemia International Normalised Ratio Decreased Date:02/06/03ISR Number: 4051885-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12154464 Age:2 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Abilify Tabs 15 Mg PS Otsuka Hospitalization - Body Temperature Pharmaceutical Initial or Prolonged Increased Company, Ltd. ORAL Other Bowel Sounds Abnormal Coordination Abnormal Electrocardiogram Qt Corrected Interval Prolonged Lethargy Loss Of Consciousness Platelet Count Abnormal Somnolence Tremor Vomiting White Blood Cell Count Abnormal 22-Feb-2006 08:31 AM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/03ISR Number: 4052026-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12158234 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Aripiprazole PS Otsuka Initial or Prolonged Paranoia Pharmaceutical Company, Ltd. ORAL Dose reduced to 15 mg/day Ativan C Date:02/06/03ISR Number: 4052703-9Report Type:Direct Company Report #CTU 186131 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Abilify 20mg Bristol Initial or Prolonged Myers Squibb PS Bristol Myers Squibb ORAL 20MG PO QD Required Abilify 10mg Bristol Intervention to Myers Squibb SS Bristol Myers Squibb ORAL 10MG PO QD Prevent Permanent Oxybutin C Impairment/Damage Benztropine C Date:02/10/03ISR Number: 4053110-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175006 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. No information provided Date:02/10/03ISR Number: 4053313-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12178208 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. No information provided Date:02/10/03ISR Number: 4055467-8Report Type:Expedited (15-DaCompany Report #A0394895A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Wellbutrin Sr Syndrome Professional Tablet-Controlled Company Release (Bupropion Representative Hydrochloride) PS Aripiprazole (Formulation Unknown) (Aripiprazole) SS 22-Feb-2006 08:31 AM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/03ISR Number: 4054926-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12184008 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphocyte Count Abilify PS Otsuka Other Decreased Pharmaceutical Malaise Company, Ltd. 2 MON White Blood Cell Count Increased Date:02/12/03ISR Number: 4054927-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12176566 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Abilify PS Otsuka Other Increased Pharmaceutical Aspartate Company, Ltd. ORAL 15 mg/day on Aminotransferase 06-Jan and Increased 07-Jan-03. Blood Glucose Abnormal Increased to Blood Ph Decreased 30 mg/day on Cardiac Disorder Catapressan SS ORAL Cardio-Respiratory Arrest Trileptal C 600mg: Cardiomegaly 08Jan03; Cataract 1200: 09Jan - Conduction Disorder 14Jan; Contusion 1800mg: 15Jan Coronary Artery Disease Haldol Decanoate C INTRAMUSCULAR 100 mg/day on Dilatation Atrial 09-Jan-2003 Electroencephalogram and Abnormal 17-Jan-2003 Fall Cogentin C Haemorrhage Depakote C Hypertension Laceration Myocardial Ischaemia Pco2 Increased Sinus Tachycardia Date:02/12/03ISR Number: 4054928-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12181277 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Synthroid C Depakote C Celex C Date:02/12/03ISR Number: 4054931-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12178216 Age:51 YR Gender:Male I/FU:I Outcome PT Death Abnormal Behaviour Other Blood Pressure Increased Blood Sodium Decreased Cardio-Respiratory Arrest 22-Feb-2006 08:31 AM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Circulatory Collapse Coma Confusional State Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL 15 mg/day on 27Dec02, 20 mg/day on 28Dec02, 30 mg/day on Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day on 27Dec02, 20 mg/day on 28Dec02, 30 mg/day on Lisinopril C Merck Research Labs 5mg on 30Dec02 - 01Jan03: 10mg on 02Jan03 - 17Jan03. Trileptal C 600mg 27Dec02-01Jan 03: 1200mg on 02Jan: 1500mg 03Jan-12Jan: Klonopin C 1mg on 27Dec02 to 28Dec02 then 0.5mg on 29Dec02 then Depakote C Clozapine C 25mg 03-05Jan:75mg 06-07Jan:100m g 08-09Jan:150m Haldol Decanoate C INTRAMUSCULAR received one(100mg) dose on 02Jan03/secon d dose on Date:02/12/03ISR Number: 4054948-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173894 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Abilify PS Otsuka Hospitalization - Asthma Pharmaceutical Initial or Prolonged Blood Pressure Increased Company, Ltd. 15mg: Other Cardio-Respiratory Arrest 04-Jan-03; Death 30mg: from Drooling 05-Jan-03 Dyspnoea Chonidine SS ORAL 0.1 mg given Pyrexia on 09-Jan-03, Somnolence 0.1mg given Treatment Noncompliance on 13-Jan-03, Vomiting 0.1 mg given Clozaril C started at 22-Feb-2006 08:31 AM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 150mg, titrated up to 700mg Trileptal C Lasix C Albuterol C albuterol via nebulizer treatment Atrovent C Atrovent via nebulizer treatment Haldol C 20 mg on 04Jan03, 13Jan03, and 15Jan03. 10 mg given on Depakene C Haldol Decanoate C INTRAMUSCULAR 150mg on 05Jan03 and 12Jan03, 100mg on 09Jan03 Cogentin C 0.1 mg taken on 04-Jan-03 and 05-Jan-03 Norvasc C Serax C 30 mg on 04-Jan-03, 05-Jan-03 and 15-Jan-03 Folate C Contraceptive C ORAL reported as "oral contraceptive s" Multivitamins C Iron Supplement C Date:02/14/03ISR Number: 4057169-0Report Type:Direct Company Report #CTU 186743 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Abilify 20mg Bristol Initial or Prolonged Myers Squibb PS Bristol Myers Squibb ORAL 20MG PO QD Required Abilify 10mg Bristol Intervention to Myers Squibb SS Bristol Myers Squibb ORAL 10MG PO QD Prevent Permanent Oxybutin C Impairment/Damage Benztropine C Date:02/19/03ISR Number: 4057724-8Report Type:Direct Company Report #CTU 186818 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Abilify Initial or Prolonged Haematemesis (Aripiprazole) 10mg PS ORAL 15MG QD PO Haematocrit Decreased Lithium Carbonate C Risperdol C Seroquel C 22-Feb-2006 08:31 AM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/03ISR Number: 4057832-1Report Type:Direct Company Report #CTU 186877 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Abilify Or PS 30MG Cardiac Arrest Abilify With SS Condition Aggravated Clonidine SS Fall Laceration Date:02/21/03ISR Number: 4058367-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185401 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:02/21/03ISR Number: 4058505-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12158234 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Aripiprazole PS Otsuka Initial or Prolonged Paranoia Professional Pharmaceutical Company, Ltd. ORAL Dose reduced to 15 mg/day on 20-Dec-2002; discontinued Ativan C Date:02/21/03ISR Number: 4058506-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185476 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Abilify Tabs 10 Mg PS Otsuka Increased Professional Pharmaceutical Electrocardiogram Qt Company, Ltd. ORAL 22-Jan-2003 Corrected Interval 10 mg/day Prolonged increased on Electrocardiogram Qt 22-Jan-2003 Prolonged to 20 mg/day Excoriation Depakote C Fall Seroquel C Heart Rate Increased Lanoxin C Hypertension Plavix C Regulatory Health Authority South Africa Amiodarone C Lopressor C Ecotrin C Dilantin C Clozaril C 22-Feb-2006 08:31 AM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/03ISR Number: 4058507-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12183703 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Health Abilify Tabs 10 Mg PS Otsuka Chest Pain Professional Pharmaceutical Lethargy Company, Ltd. ORAL Patient takes Peripheral Coldness half of a 10 Pharyngolaryngeal Pain mg tablet Tachycardia Trileptal C Clonidine C Date:02/25/03ISR Number: 4059783-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185823 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Abilify Tabs 15 Mg PS Otsuka Coronary Artery Pharmaceutical Atherosclerosis Company, Ltd. ORAL Loss Of Consciousness Serzone C Bristol-Myers Squibb Respiratory Arrest Company ORAL Effexor Xr C Lorazepam C Remeron C Risperdal C Date:02/25/03ISR Number: 4059949-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12181277 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oxygen Saturation Health Abilify Tabs 15 Mg PS Otsuka Decreased Professional Pharmaceutical Sedation Company, Ltd. ORAL Somnolence Zyprexa C 30 mg (start date not reported)decr eased to 20 mg/day Synthroid C Depakote C 500 mg AM; 1500 mg at hour of sleep Celexa C Date:02/27/03ISR Number: 4061922-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12188942 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Aripiprazole PS Otsuka Initial or Prolonged Paranoia Professional Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062336-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12184008 Age:51 YR Gender:Male I/FU:F Outcome PT Death Coma Other Cough 22-Feb-2006 08:31 AM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Lymphocyte Count Decreased Report Source Product Role Manufacturer Route Dose Duration Malaise Health Abilify Tabs 30 Mg PS Otsuka Sudden Death Professional Pharmaceutical White Blood Cell Count Company, Ltd. 1 month @15 Increased mg/day titrated to 30 mg/day for 1 month prior 1 MON Clozaril C Trileptal C Date:02/28/03ISR Number: 4062337-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12119103 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Hypoaesthesia Pharmaceutical Paraesthesia Company, Ltd. ORAL Pupils Unequal Lithium C Somnolence Vision Blurred Date:02/28/03ISR Number: 4062338-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12120606 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062339-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12120622 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Choking Abilify PS Otsuka Dysgeusia Pharmaceutical Insomnia Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Duragesic Patch C Vivelle C Lipitor C Insulin C Vasotec C Vicodin C Halcion C Diazepam C Ibuprofen C 22-Feb-2006 08:31 AM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062340-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12120945 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Jittery Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062341-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12121778 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cold Sweat Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Trileptal C Glucophage C Bristol-Myers Squibb Company Micardis C Lopid C Date:02/28/03ISR Number: 4062342-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12127692 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify PS Otsuka Phosphokinase Pharmaceutical Myalgia Company, Ltd. ORAL dates and dosage not available Anafranil C Accupril C Urecholine C Xanax C Date:02/28/03ISR Number: 4062343-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12128823 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062344-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12130118 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify PS Otsuka Increased Appetite Pharmaceutical Sleep Disorder Company, Ltd. ORAL 16 DAY Clozaril C Depakote C 22-Feb-2006 08:31 AM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062345-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12132130 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Abilify PS Otsuka Inflammation Pharmaceutical Swelling Company, Ltd. ORAL 4 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 4 DAY Dalmane C Ativan C Date:02/28/03ISR Number: 4062346-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12133229 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Aripiprazole PS Otsuka Depressed Level Of Pharmaceutical Consciousness Company, Ltd. ORAL Restlessness Risperdal C Thought Broadcasting Date:02/28/03ISR Number: 4062347-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12134813 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Photophobia Company, Ltd. ORAL Geodon C Ativan C Lithium C Date:02/28/03ISR Number: 4062348-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12135133 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Abilify PS Otsuka Paraesthesia Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062349-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12136206 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Myalgia Pharmaceutical Nausea Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Bactrim Ds C 22-Feb-2006 08:31 AM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062350-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12136909 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Date:02/28/03ISR Number: 4062351-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12137113 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Norvasc C Inderal C Ranitidine C Hyoscyamine C Ibuprofen C Colestid C Fluoxetine C Date:02/28/03ISR Number: 4062352-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12137121 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Lamictal C Bristol-Myers Squibb Company Synthroid C Ambien C Xanax C Date:02/28/03ISR Number: 4062353-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12138400 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Proventil Inhaler C Vanceril Inhaler C 22-Feb-2006 08:31 AM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062354-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12140224 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Depressed Level Of Pharmaceutical Consciousness Company, Ltd. ORAL Feeling Cold Singulair C Feeling Jittery Ery-Tab C Hypokinesia Insomnia Nervousness Date:02/28/03ISR Number: 4062355-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12140927 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Abilify Tabs 10 Mg PS Otsuka Ear Discomfort Pharmaceutical Headache Company, Ltd. ORAL Hyperhidrosis Abilify Tabs 10 Mg SS Otsuka Nasal Congestion Pharmaceutical Nausea Company, Ltd. ORAL Rhinorrhoea Seroquel C Throat Tightness Lithium C Toothache Prevacid C Cardizem C Zanaflex C Wellbutrin C Date:02/28/03ISR Number: 4062356-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12141016 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Glucotrol Xl C Glucophage Xr Tabs C Bristol-Myers Squibb Company Wellbutrin C Accupril C Avapro C Bristol-Myers Squibb Company Nexium C Lopid C Multivitamin C Aspirin C Date:02/28/03ISR Number: 4062357-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12141842 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Torticollis Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Xanax C Prozac C Date:02/28/03ISR Number: 4062358-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12141859 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062359-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12142964 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Date:02/28/03ISR Number: 4062360-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143012 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Nausea Pharmaceutical Sleep Disorder Company, Ltd. Date:02/28/03ISR Number: 4062361-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143152 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062362-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143418 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Pain In Extremity Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062363-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143426 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify PS Otsuka Sedation Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C 22-Feb-2006 08:31 AM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062364-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062365-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143715 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Abilify Tabs 15 Mg PS Otsuka Difficulty In Walking Pharmaceutical Dizziness Company, Ltd. ORAL Insomnia Remeron C Tremor Date:02/28/03ISR Number: 4062366-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12144366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Vertigo Pharmaceutical Company, Ltd. Geodon C Date:02/28/03ISR Number: 4062367-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12144952 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Seroquel SS Date:02/28/03ISR Number: 4062368-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12145025 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Abilify PS Otsuka Initial or Prolonged Influenza Like Illness Pharmaceutical Opisthotonus Company, Ltd. ORAL Frequency and Pyrexia therapy dates Rash not reported 3 DAY Torticollis Date:02/28/03ISR Number: 4062369-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12145223 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 15 Mg PS Otsuka Incoherent Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062370-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12146288 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Dizziness Pharmaceutical Insomnia Company, Ltd. ORAL Vomiting Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Trileptal C Effexor C Lorazepam C Date:02/28/03ISR Number: 4062371-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12146742 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Seroquel C Date:02/28/03ISR Number: 4062372-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12147393 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C Date:02/28/03ISR Number: 4062373-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12147559 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Cogentin C Ambien C Klonopin C Seroquel C Date:02/28/03ISR Number: 4062374-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12147724 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Other Phosphokinase Increased Company, Ltd. ORAL Dystonia Thorazine C Muscle Contractions Paxil C Involuntary Muscle Rigidity Myalgia Psychotic Disorder Pyrexia 22-Feb-2006 08:31 AM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062375-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12147849 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062376-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12147948 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify PS Otsuka Restlessness Pharmaceutical Company, Ltd. Geodon C Date:02/28/03ISR Number: 4062377-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12148029 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphonia Abilify Tabs 10 Mg PS Otsuka Crepitations Pharmaceutical Diarrhoea Company, Ltd. ORAL Dizziness Flovent C Dyspepsia Combivent C Dyspnoea Albuterol C Gastrooesophageal Reflux Effexor C Disease Serevent C Headache Zyprexa C Insomnia Prilosec C Nasopharyngitis Nightmare Pharyngolaryngeal Pain Suicidal Ideation Throat Tightness Vomiting Date:02/28/03ISR Number: 4062378-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12150181 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sensation Of Heaviness Abilify PS Otsuka Tachycardia Pharmaceutical Tremor Company, Ltd. ORAL Dose and frequency not provided Date:02/28/03ISR Number: 4062379-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12150264 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eructation Abilify Tabs 15 Mg PS Otsuka Flatulence Pharmaceutical Vision Blurred Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Zyprexa C Date:02/28/03ISR Number: 4062380-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12150272 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Ambien C Depakote C Prevacid C Date:02/28/03ISR Number: 4062381-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12150348 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cough Abilify PS Otsuka Hiccups Pharmaceutical Libido Increased Company, Ltd. ORAL Dosage Throat Irritation increased to 10 mg on 30 Dec 02. Luvox C Klonopin C Doryx C Prempro C Synthroid C Topamax C Date:02/28/03ISR Number: 4062382-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12150355 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Cold Abilify PS Otsuka Headache Pharmaceutical Nausea Company, Ltd. ORAL Piloerection Depakote C Platelet Count Increased Ortho Cyclen C Pyrexia White Blood Cell Count Increased Date:02/28/03ISR Number: 4062383-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12150447 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Irritability Pharmaceutical Nervousness Company, Ltd. ORAL Zyprexa C Lexapro C Lithium C Depakote C 22-Feb-2006 08:31 AM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062384-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151544 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify PS Otsuka Dizziness Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062385-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151569 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062386-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151676 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Aripiprazole PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062387-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151692 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify PS Otsuka Hiccups Pharmaceutical Sleep Disorder Company, Ltd. ORAL Dosage not reported Lorazepam C Zyprexa C Seroquel C Date:02/28/03ISR Number: 4062388-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151890 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Nausea Company, Ltd. ORAL Rash Date:02/28/03ISR Number: 4062389-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12152260 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062390-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153201 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL Prozac C Ritalin C Monopril C Bristol-Myers Squibb Company Date:02/28/03ISR Number: 4062391-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153482 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Glucovance C Bristol-Myers Squibb Company Zestoretic C Lasix C Zoloft C Xanax C Topamax C Lomotil C Magnesium C Potassium C Date:02/28/03ISR Number: 4062392-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153557 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mouth Ulceration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Trazodone Hcl Tabs C Apothecon 1 DAY Date:02/28/03ISR Number: 4062393-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153664 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Haldol C Prozac C 22-Feb-2006 08:31 AM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Date:02/28/03ISR Number: 4062394-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153680 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs 10 Mg PS Otsuka Dizziness Pharmaceutical Insomnia Company, Ltd. ORAL Nausea Glucophage Tabs 500 Night Sweats Mg SS Bristol-Myers Squibb Peripheral Coldness Company ORAL Naprosyn C Levothroid C Vitamin E C Lutein C Ambien C Date:02/28/03ISR Number: 4062395-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153730 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Taken at nighttime. skipped 07Jan dose. to start 15mg Lithium C Klonopin C Date:02/28/03ISR Number: 4062396-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153755 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Nausea Pharmaceutical Sleep Disorder Company, Ltd. Date:02/28/03ISR Number: 4062397-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153771 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Restlessness Pharmaceutical Company, Ltd. 2 WK Zyprexa C Date:02/28/03ISR Number: 4062398-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Sleep Disorder Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062399-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153813 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Sodium Decreased Abilify PS Otsuka Convulsion Pharmaceutical Company, Ltd. Escitalopram C Date:02/28/03ISR Number: 4062400-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12153888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Jittery Abilify Tabs 30 Mg PS Otsuka Psychomotor Hyperactivity Pharmaceutical Company, Ltd. ORAL 9 DAY Remeron C Lamictal C Bristol-Myers Squibb Company Date:02/28/03ISR Number: 4062401-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12154589 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Abilify PS Otsuka Initial or Prolonged Suicide Attempt Pharmaceutical Other Company, Ltd. Date:02/28/03ISR Number: 4062402-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12154738 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Nausea Company, Ltd. ORAL Paraesthesia Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C Date:02/28/03ISR Number: 4062403-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12154761 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Abilify Tabs 15 Mg PS Otsuka Diabetes Mellitus Pharmaceutical Dry Mouth Company, Ltd. ORAL Dysphonia Risperdal C TITRATING Hyperacusis Prozac C Insomnia Restoril C Paraesthesia Glucophage Xr Tabs C Bristol-Myers Squibb Visual Disturbance Company Vulvovaginal Discomfort Procardia Xl C Cozaar C Bristol-Myers Squibb Company Tricor C Allegra C Cardizem C 22-Feb-2006 08:31 AM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062404-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12154910 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Abilify Tabs 15 Mg PS Otsuka Dizziness Pharmaceutical Dystonia Company, Ltd. ORAL Discontinued Headache Abilify Tabs 15 Mg SS Otsuka Opisthotonus Pharmaceutical Company, Ltd. ORAL Discontinued Date:02/28/03ISR Number: 4062405-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12155990 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL at bedtime Date:02/28/03ISR Number: 4062406-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12156212 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 DAY Date:02/28/03ISR Number: 4062407-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12156220 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sexual Dysfunction Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Date:02/28/03ISR Number: 4062408-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12156246 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062409-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12157210 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Jittery Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Patient lost her medication after the first dose 22-Feb-2006 08:31 AM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062410-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12157244 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Hypoaesthesia Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062411-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12157269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062412-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12157624 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062413-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12158036 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Abilify Tabs 15 Mg PS Otsuka Sedation Pharmaceutical Company, Ltd. ORAL Lexapro C Date:02/28/03ISR Number: 4062414-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12158366 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify Tabs 15 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL 1 WK Gemfibrozil C Plavix C Regulatory Health Authority South Africa Seroquel C Lithium C Prinivil C Merck Research Labs Date:02/28/03ISR Number: 4062415-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12158440 Age:17 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aspartate Initial or Prolonged Aminotransferase Increased Blood Creatine Phosphokinase Increased 22-Feb-2006 08:31 AM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased Headache Report Source Product Role Manufacturer Route Dose Duration Myalgia Abilify Tabs 15 Mg PS Otsuka Neck Pain Pharmaceutical Toothache Company, Ltd. ORAL 1 WK Depakote C 500 mg in the morning, 1000 mg in the evening Wellbutrin C Date:02/28/03ISR Number: 4062416-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12159711 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Abilify Tabs PS Otsuka Schizophrenia Professional Pharmaceutical Company, Ltd. ORAL Started on 15mg/increase d to 30mg over 3-4 weeks/discont Valproic Acid C Cogentin C Date:02/28/03ISR Number: 4062417-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12160263 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Fear Pharmaceutical Company, Ltd. ORAL Prolixin C Apothecon Risperdal C Cogentin C Synthroid C Multivitamin With Minerals C Date:02/28/03ISR Number: 4062418-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12160909 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Consumer Abilify Tabs PS Otsuka Memory Impairment Pharmaceutical Somnolence Company, Ltd. ORAL Actual dose Thinking Abnormal 0.225mg Vision Blurred Cytomel C Diazepam C Hydrocodone C Lithium C Atenolol C Apothecon K-Dur C Lasix C Guaifenesin C 22-Feb-2006 08:31 AM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062419-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12161048 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Klonopin C Date:02/28/03ISR Number: 4062420-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12161477 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Increased Pharmaceutical Aspartate Company, Ltd. ORAL Actual dates Aminotransferase not indicated Increased Date:02/28/03ISR Number: 4062421-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12162467 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Consumer Abilify Tabs PS Otsuka Feeling Jittery Pharmaceutical Tremor Company, Ltd. ORAL Neurontin C Methadone C Valium C Date:02/28/03ISR Number: 4062422-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12162509 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Abilify Tabs PS Otsuka Dystonia Professional Pharmaceutical Muscle Twitching Company, Ltd. Date:02/28/03ISR Number: 4062423-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12163051 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Takes half of a 15 mg tablet. Discontinued medication Date:02/28/03ISR Number: 4062424-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12163853 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Abilify Tabs 15 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Buspar Tabs C Bristol-Myers Squibb Company Taxol C Bristol-Myers Squibb Company Cogentin C Lorazepam C Date:02/28/03ISR Number: 4062425-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12163903 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Palpitations Abilify Tabs 15 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Started on 10mg two months ago/increased to Navane C Cogentin C Date:02/28/03ISR Number: 4062426-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12164117 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. Increased to 15mg BID/exact date unknown Valproic Acid C Clonidine C Date:02/28/03ISR Number: 4062427-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12164323 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. No information given Date:02/28/03ISR Number: 4062428-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12164463 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Abilify PS Otsuka Initial or Prolonged Consciousness Pharmaceutical Hypotonia Company, Ltd. No information given 22-Feb-2006 08:31 AM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062429-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12164786 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C MD increased dosage to 1500mg per day after adverse Risperdal C Cogentin C Vitamin E C Date:02/28/03ISR Number: 4062430-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12164844 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Consumer Abilify Tabs 20 Mg PS Otsuka Cough Pharmaceutical Menstruation Irregular Company, Ltd. ORAL On 01/13/2003 Panic Attack dosage increased to 25mg daily. Then Lamictal C Bristol-Myers Squibb Company Ativan C Date:02/28/03ISR Number: 4062431-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12164919 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Abilify Tabs 30 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Zyprexa C Depakote C Adderall C Tricor C Date:02/28/03ISR Number: 4062432-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12165411 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify Tabs 15 Mg PS Otsuka Constipation Pharmaceutical Faecaloma Company, Ltd. ORAL Dosage Haematoma increased to Head Injury 30mg per day, Insomnia then discontinued. Valproic Acid C Zestril C Clonidine C Naltrexone C 22-Feb-2006 08:31 AM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062433-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12165619 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Exact dosage and dates not indicated. Depakote C Metoprolol C Zoloft C Effexor C Fish Oil C Wellbutrin C Date:02/28/03ISR Number: 4062434-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12166153 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062435-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12166179 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Insomnia Pharmaceutical Company, Ltd. No information provided Date:02/28/03ISR Number: 4062436-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12166237 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Adderall C ORAL Date:02/28/03ISR Number: 4062437-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12166245 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Health Aripiprazole PS Otsuka Professional Pharmaceutical Company, Ltd. Depakote C Adderall C 22-Feb-2006 08:31 AM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062438-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12166252 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062439-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12166294 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062440-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12166500 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. No information provided Date:02/28/03ISR Number: 4062441-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12167367 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL 5 mg HS 1 WK Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg HS 1 WK Wellbutrin C Cogentin C Date:02/28/03ISR Number: 4062442-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12167532 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Abilify Tabs 15 Mg PS Otsuka Headache Pharmaceutical Insomnia Company, Ltd. ORAL dose not Nausea taken on 22 Tinnitus Jan 03 and 23 Vomiting Jan 03 Xanax C Albuterol Inhaler C Aspirin C ORAL 1/2 tablet 22-Feb-2006 08:31 AM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062443-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12167730 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062444-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12167763 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/03ISR Number: 4062445-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12168126 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. Paroxetine C Topiramate C Date:02/28/03ISR Number: 4062446-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12169231 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. No information provided Date:02/28/03ISR Number: 4062447-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12169306 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs 15 Mg PS Otsuka Diarrhoea Pharmaceutical Difficulty In Walking Company, Ltd. ORAL Disturbance In Attention Depakote C Dizziness Nexium C Eating Disorder Levoxyl C Nervousness Vision Blurred Weight Decreased Date:02/28/03ISR Number: 4062448-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12169926 Age:20 YR Gender:Female I/FU:I Outcome PT Hospitalization - Electrocardiogram Qt Initial or Prolonged Prolonged Other Orthostatic Hypotension 22-Feb-2006 08:31 AM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Taken for "2 to 3 months". Interrupted on 28 Jan 03. Trazodone Hcl Tabs C Apothecon Effexor C Topamax C Albuterol C Date:02/28/03ISR Number: 4062449-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12170189 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify Tabs 15 Mg PS Otsuka Anger Pharmaceutical Nausea Company, Ltd. ORAL Personality Disorder Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:02/28/03ISR Number: 4062450-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12170239 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 10 Mg PS Otsuka Pain Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Prozac C Date:02/28/03ISR Number: 4062451-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12170593 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Somnolence Company, Ltd. ORAL Multivitamins C Date:02/28/03ISR Number: 4062452-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12170619 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 1/2 tablet of 10 mg on 14 Jan 22-Feb-2006 08:31 AM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 03/Increased Atenolol C Apothecon Prevacid C Glyburide C Geneva Pharmaceutical,Inc. Lipitor C Calcium C Multivitamins C Date:02/28/03ISR Number: 4062453-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12171039 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Cogentin C Date:02/28/03ISR Number: 4062454-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12171054 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Takes 1/4 of a pill. Date:02/28/03ISR Number: 4062455-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12171377 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Abilify Tabs 15 Mg PS Otsuka Loss Of Libido Pharmaceutical Sexual Dysfunction Company, Ltd. ORAL Exact dates not provided Date:02/28/03ISR Number: 4062456-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12171393 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify PS Otsuka Aggression Pharmaceutical Company, Ltd. No information provided Date:02/28/03ISR Number: 4062457-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12171708 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril C Ddavp C Effexor Xr C Hctz C 22-Feb-2006 08:31 AM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062458-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12172029 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Exact dates not provided Date:02/28/03ISR Number: 4062459-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12172045 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C Paxil C Adderall C Date:02/28/03ISR Number: 4062460-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12172292 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Celexa C Zyprexa C Accupril C Celebrex C Tylenol C Date:02/28/03ISR Number: 4062461-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12172375 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Abilify Tabs 15 Mg PS Otsuka Loss Of Libido Pharmaceutical Sexual Dysfunction Company, Ltd. ORAL Date:02/28/03ISR Number: 4062462-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12172755 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Abilify Tabs 15 Mg PS Otsuka Migraine Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Zonegran C 22-Feb-2006 08:31 AM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Maxidex C Menest C Provera C Klonopin C Allegra-D C Nasal Spray C Fosamax C Geodon C Prolixin C Apothecon Date:02/28/03ISR Number: 4062463-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173225 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Drooling Pharmaceutical Dysphasia Company, Ltd. ORAL Dose Fatigue increased to Sedation 30 mg/day during the week of 06 Haldol C Depakote C Paxil C Date:02/28/03ISR Number: 4062464-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173233 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs 15 Mg PS Otsuka Dysphasia Pharmaceutical Dyspnoea Company, Ltd. ORAL Fatigue Risperdal C ORAL Sedation Date:02/28/03ISR Number: 4062465-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173530 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify Tabs 10 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Date:02/28/03ISR Number: 4062466-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173548 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Abilify Tabs 15 Mg PS Otsuka Consciousness Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Dizziness Klonopin C Fatigue Zyprexa C Feeling Abnormal Effexor C Sedation Trileptal C Vision Blurred Visual Acuity Reduced 22-Feb-2006 08:31 AM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062467-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173555 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrasystoles Abilify PS Otsuka Joint Swelling Pharmaceutical Company, Ltd. No information provided Date:02/28/03ISR Number: 4062468-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175212 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. No information provided Date:02/28/03ISR Number: 4062469-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12179362 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faeces Discoloured Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:03/03/03ISR Number: 4064892-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194544 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Communication Disorder Pharmaceutical Mental Status Changes Company, Ltd. ORAL Started on Personality Change 15mg, exact date unknown/dosag e was Date:03/07/03ISR Number: 4068034-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194536 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 - 15 mg/day for a month or two 1 MON Risperdal C Zyprexa C 22-Feb-2006 08:31 AM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/03ISR Number: 4068088-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12195061 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Delusion Pharmaceutical Dementia Company, Ltd. ORAL 18 DAY Hallucination, Auditory Verapamil C Insomnia Risperdal C Paranoia Depakote C Lithium C Artane C Pepcid C Date:03/07/03ISR Number: 4069503-6Report Type:Direct Company Report #CTU 188194 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Jaw Disorder Abilify PS Bristol-Myers Squibb ORAL 10 MG 1 QD Required Joint Stiffness ORAL Intervention to Muscle Rigidity Abilify SS Bristol-Myers Squibb ORAL 5 MG 1 QD Prevent Permanent ORAL Impairment/Damage Clonazepam C Clotrimazole C Divalproex C Maalox C Date:03/10/03ISR Number: 4068635-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12152492 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Abilify Tabs 15 Mg PS Otsuka Hospitalization - Confusional State Pharmaceutical Initial or Prolonged Drug Toxicity Company, Ltd. ORAL 1 MON Disability Encephalopathy Hyperammonaemia International Normalised Ratio Decreased Miosis Date:03/10/03ISR Number: 4068639-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151007 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anoxic Encephalopathy Abilify Tabs 15 Mg PS Otsuka Hospitalization - Blood Creatine Pharmaceutical Initial or Prolonged Phosphokinase Increased Company, Ltd. ORAL Brain Hypoxia Abilify Tabs 15 Mg SS Otsuka Cardiac Arrest Pharmaceutical Coma Company, Ltd. ORAL Dizziness Abilify Tabs 15 Mg SS Otsuka Loss Of Consciousness Pharmaceutical Muscle Rigidity Company, Ltd. ORAL Pyrexia Abilify Tabs 15 Mg SS Otsuka Renal Failure Pharmaceutical Rhabdomyolysis Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Risperidone C Flexeril C Effexor C Amitriptyline C Insulin C Ace Inhibitor C Ativan C Lexapro C Ambien C Ultram C Seroquel C Altace C Celebrex C Zantac C Fexofenadine Hcl C Date:03/10/03ISR Number: 4068855-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12103487 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Date:03/11/03ISR Number: 4069296-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12135786 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Aripiprazole PS Otsuka Initial or Prolonged Insomnia Pharmaceutical Schizoaffective Disorder Company, Ltd. ORAL Wellbutrin SS Prozac SS Topamax C Klonopin C Date:03/12/03ISR Number: 4072218-1Report Type:Direct Company Report #USP 55578 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Abilify(Aripiprazole ) PS Bms Prilosec(Omeprazole) SS Astra Zeneca Prevacid(Lansoprazol e) SS Tap 22-Feb-2006 08:31 AM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/03ISR Number: 4072972-9Report Type:Direct Company Report #CTU 188595 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Aibilify (Aripiprazole) 15 Mg -Osuka PS Osuka ORAL 15 MG P.O. Geodon C Date:03/13/03ISR Number: 4073532-6Report Type:Direct Company Report #CTU 188662 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Aripiprazole PS Intervention to Drug Interaction Fluoxetine SS Prevent Permanent Muscle Spasms Impairment/Damage Sleep Disorder Tremor Date:03/13/03ISR Number: 4073570-3Report Type:Direct Company Report #CTU 188668 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Full Blood Count Abnormal Abilify-Otsulka Neutrophil Count American /Bristol Decreased -Myers Squibb PS Otsulka American /Bristol -Myers Squibb ORAL 15MG DAILY PO, 30MG DAILY PO Vit E C Seroquel C Date:03/17/03ISR Number: 4072969-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12139192 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Blinded: Initial or Prolonged Upper Limb Fracture Professional Aripiprazole PS Otsuka Other Pharmaceutical Company, Ltd. ORAL dose decreased - date not reported Tylenol + Codeine No. 3 SS Date:03/17/03ISR Number: 4074780-1Report Type:Direct Company Report #CTU 188868 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Abilify Hospitalization - Back Pain -Aripiprazole- 15 Mg Initial or Prolonged Chest Pain Bristol-Myers-Squibb PS Bristol-Myers Squibb ORAL 15 MG QA.M. Required Pain ORAL Intervention to Pleural Infection Risperdal C Prevent Permanent Pneumonia Lithium Carbonate C Impairment/Damage Pulmonary Embolism Omega-3 C 22-Feb-2006 08:31 AM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/03ISR Number: 4073395-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194536 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 - 15 mg/day for a month or two 1 MON Risperdal C 3 YR Zyprexa C Haldol Decanoate C Amantadine C Topamax C Depakote C Diphenhydramine C Date:03/18/03ISR Number: 4073625-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204178 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Haloperidol Decanoate C "On for several years" Artane C 2mg every am/ 5mg every night at hour of sleep. "On for several Date:03/18/03ISR Number: 4075558-5Report Type:Direct Company Report #CTU 188988 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Abilify Rash Papular (Aripiprazole) PS UNKNOWN UNKNOWN - OTHER PRESCRITER Lithium C Seroquel C Klonopin C Nexium C Trileptal C Wellbutrin C Celebrex C Date:03/19/03ISR Number: 4074162-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206215 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Death Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. No information provided 22-Feb-2006 08:31 AM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/03ISR Number: 4076515-5Report Type:Direct Company Report #CTU 189072 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Aripiprazole 15mg Initial or Prolonged Blood Creatine Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 15MG QD ORAL Phosphokinase Increased Divalproex C Confusional State Ziprasidone C Delirium Paroxetine C Mental Status Changes Benztropine C Monocyte Count Increased Nervous System Disorder White Blood Cell Count Increased Date:03/20/03ISR Number: 4077293-6Report Type:Direct Company Report #CTU 189147 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Aripiprazole Dyskinesia (Abilify) PS ORAL 15 MG PO QD Glucosamine C Valproic Acid C Synthroid C Vitamin E C Celexa C Carmel C Multiple Vitamins C Relafen C Aspirin C Moistruel C Aralgesic Balm C Kaopectate C Chlorphenramine C Vistamil C Maalox C Milk Of Magnesia C Acetaminophen C Robitussin C Cepacol C Date:03/20/03ISR Number: 4078180-XReport Type:Direct Company Report #CTU 189165 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify-15 Mg 1 Tab Po At PS ORAL 15MG - 1 TAB PO @ HS Date:03/21/03ISR Number: 4078312-3Report Type:Direct Company Report #CTU 189248 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Aripiprazole PS Intervention to Muscle Spasms Fluoxetine SS Prevent Permanent Tremor ... C Impairment/Damage ... C 22-Feb-2006 08:31 AM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/03ISR Number: 4078543-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204178 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 15 Mg PS Otsuka Myocardial Infarction Pharmaceutical Company, Ltd. ORAL Started on 5mg/increased to 10mg/increase d to 15mg on 7 WK Haloperidol Decanoate C "On for several years" Artane C "On for several years" Losartan C "On for several years" Propranolol C "on for several years" Ibuprofen C "On for several years" Fluticasone C Vitamin E C Multivitamin C Hydrochlorothiazide C Date:03/26/03ISR Number: 4082450-9Report Type:Direct Company Report #CTU 189553 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Abilify Otsuka Convulsion Bristol Myers Squibb PS Otsuka Bristol Myers Eye Movement Disorder Squibb ORAL ORAL, DAILY Muscle Rigidity AT 6PM Lorazepam C Date:03/27/03ISR Number: 4079691-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217824 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Aripiprazole PS Otsuka Initial or Prolonged Fall Pharmaceutical Hip Fracture Company, Ltd. ORAL Interrupted on 19-Mar-2003. Furosemide SS Trazodone Hcl SS Apothecon Isosorbide SS Zestril SS Levothyroxine C Potassium C 22-Feb-2006 08:31 AM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/03ISR Number: 4079714-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12216685 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Interrupted-n o date provided Date:03/27/03ISR Number: 4082803-9Report Type:Direct Company Report #USP 55745 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Abilify (Aripiprazole) PS Bms Prevacid(Lansoprazol e) SS Tap Date:03/28/03ISR Number: 4080366-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12216636 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Other Fall Pharmaceutical Restlessness Company, Ltd. ORAL 1 DAY Self Injurious Behaviour Depakote C Lithium C Risperdal C Provigil C Protriptyline C Glucophage C Bristol-Myers Squibb Company Date:03/28/03ISR Number: 4080393-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12154464 Age:2 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Abilify Tabs 15 Mg PS Otsuka Hospitalization - Coordination Abnormal Pharmaceutical Initial or Prolonged Haematocrit Decreased Company, Ltd. ORAL Other Lethargy Loss Of Consciousness Medication Error Sinus Tachycardia Somnolence Thrombocythaemia Tremor Vomiting White Blood Cell Count Increased Date:03/28/03ISR Number: 4084266-6Report Type:Direct Company Report #CTU 189758 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Abilify 15mg Tab PS SEE IMAGE Salivary Hypersecretion Aspirin C 22-Feb-2006 08:31 AM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Multiple Vitamins And Minerals C Nicorette Gum C Tylenol C Haloperidol C Maalox C Milk Of Magnesia C Date:03/28/03ISR Number: 4084356-8Report Type:Direct Company Report #CTU 189732 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Aripiprazole(Abilify Extrapyramidal Disorder ) PS ORAL 20MG PO QD Dawn Mist Hand And Body Lotion C Robitussin Dm C Kaopectate C Zoloft C Vitamin E C Neurotin C Multiple Vitamins And Minerals C Famotidine C Benztropine C Cholorpheriramine C Cepacil Loterges C Maalox C Milk Of Magnesia C Tylenol C Lotramin Cream C Date:03/28/03ISR Number: 4084358-1Report Type:Direct Company Report #CTU 189734 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Aripiprazole (Abilify) PS ORAL 30MG PO QD Dimethisone C Cogetin C Ibuprofen C Tylenol C Seroquel C Chlorpheneramine C Benadryl C Robitussin Dm C Cepacol C Maalox C Milk Of Magnesia C Gentamicin C Bass Soap C Nivea Lotion C Lachydrin Cream C Duofilm C 22-Feb-2006 08:31 AM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/03ISR Number: 4084363-5Report Type:Direct Company Report #CTU 189736 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Aripiprazole Restlessness (Abilify) PS ORAL 30MG PO QD Metamucil C Flonase Nasal Spray C Simethicone C Lubiderm C Chapstick C Baby Shampoo C Qm Hemorrhoids C Alkalol Liquid C Tucks C Imodium C Allegra C Cepacol C Gaviscon Foamtab C Diabetic Tussin Pm C Pepcid C Multiple Vitamins And Minerals C Synthroid C Inderal C Colace C Eskalith C Benadryl C Hydrogen Peroxide C Baby Powder C Vioxx C Neurontin C Benadryl C Dulcolax C Maalox C Sudafed C Date:03/31/03ISR Number: 4081985-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206215 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Death Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. No information provided Date:04/01/03ISR Number: 4082380-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12218004 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Abilify Tabs 15 Mg PS Otsuka Circulatory Collapse Pharmaceutical Head Injury Company, Ltd. ORAL Laceration Lithobid C Loss Of Consciousness Aricept C Propranolol C Depakote C Ambien C 22-Feb-2006 08:31 AM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4082384-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12218210 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Dehydration Pharmaceutical Other Electrocardiogram Qt Company, Ltd. ORAL Started on Corrected Interval 10mg/Increase Prolonged d to 15mg on Oral Intake Reduced 05-Dec-2003/I Sleep Disorder ncreased to 36 DAY Lithium C Ativan C Date:04/01/03ISR Number: 4084534-8Report Type:Direct Company Report #CTU 189888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Aripiprazole Abilify Tremor 7.5 Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 7.5 MG PER DAY ORAL Date:04/01/03ISR Number: 4084981-4Report Type:Direct Company Report #CTU 189957 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Aripirazole PS Intervention to Somnolence Prevent Permanent Impairment/Damage Date:04/01/03ISR Number: 4085946-9Report Type:Direct Company Report #CTU 189926 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Abilify 15mg Qhs PS 15MG QHS Initial or Prolonged Neuroleptic Malignant Prevacid C Required Syndrome Depakote C Intervention to Speech Disorder Cogentin C Prevent Permanent Tremor Impairment/Damage Date:04/03/03ISR Number: 4087115-5Report Type:Direct Company Report #CTU 190084 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Aripiprazole Vomiting (Abilify) PS ORAL 10 MG QD PO Date:04/03/03ISR Number: 4087532-3Report Type:Direct Company Report #CTU 190179 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eye Rolling Abilify 15mg Otsuka PS Otsuka 1/2 ONE QAM Hypersensitivity AND QHS Musculoskeletal Stiffness 22-Feb-2006 08:31 AM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4084990-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12222139 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify Tabs 15 Mg PS Otsuka Hypersensitivity Pharmaceutical Company, Ltd. ORAL Exact dates not provided 1 MON Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Exact dates not provided 1 MON Claritin C Date:04/04/03ISR Number: 4085261-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12223764 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL One dose taken either on 23-Mar-2003 or 1 DAY Effexor C Taken 2 to 3 days before starting aripiprazole Date:04/07/03ISR Number: 4085612-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12222659 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Mydriasis Pharmaceutical Nausea Company, Ltd. ORAL 1 DAY Pupillary Reflex Impaired Ritalin C Dosage,dates Sinus Tachycardia not Somnolence reported/On Vomiting this "quite some time" Seroquel C No dosage or exact dates reported Topamax C No dosage or exact dates reported Date:04/08/03ISR Number: 4086080-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11765344 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Aripiprazole PS Otsuka Hospitalization - Rhabdomyolysis Professional Pharmaceutical Initial or Prolonged Sepsis Company, Ltd. ORAL Interrupted Other on 08 Mar 02. Zoloft C Ecotrin C 22-Feb-2006 08:31 AM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor C Nitroglycerine C SUBLINGUAL Acetaminophen C ORAL Prazepam C Morphine C Date:04/08/03ISR Number: 4089531-4Report Type:Direct Company Report #CTU 190418 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Aripiprazole PS Initial or Prolonged Erythema Muscle Contractions Involuntary Date:04/09/03ISR Number: 4087794-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224747 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Abilify PS Otsuka Initial or Prolonged Fall Pharmaceutical Other Musculoskeletal Stiffness Company, Ltd. ORAL Started on Sedation 20mg/Reduced to 15 mg exact date not Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 20mg/Reduced to 15 mg exact date not Aricept C Remeron C Hydrochlorothiazide C Colace C Levoxyl C Multivitamin C Date:04/11/03ISR Number: 4091099-3Report Type:Direct Company Report #CTU 190727 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify Otsuka Initial or Prolonged Electroencephalogram Pharmaceutical PS Otsuka Abnormal Pharmaceutical ABILIFY 71/2 MG QAM Paxil Cr C Remeron C Date:04/11/03ISR Number: 4091100-7Report Type:Direct Company Report #CTU 190728 Age:39 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anger Initial or Prolonged Anxiety 22-Feb-2006 08:31 AM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Report Source Product Role Manufacturer Route Dose Duration Abilify Otsuka Pharmaceuticals PS Otsuka Pharmaceuticals ABILIFY 15MG HS Ativan C Date:04/11/03ISR Number: 4091101-9Report Type:Direct Company Report #CTU 190729 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thirst Abilify PS 15 MG QD Tremor Paxil C Vision Blurred Lorazepam C Date:04/11/03ISR Number: 4091102-0Report Type:Direct Company Report #CTU 190730 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Abilify PS 15MG Q AM Initial or Prolonged Dysphagia Clonidine C Extrapyramidal Disorder Straterra C Muscle Rigidity Zoloft C Musculoskeletal Stiffness Date:04/14/03ISR Number: 4090074-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12177614 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Abilify Tabs 15 Mg PS Otsuka Oculogyration Pharmaceutical Company, Ltd. ORAL Seroquel C Prozac C Date:04/15/03ISR Number: 4090205-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12228235 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Abilify Tabs 30 Mg PS Otsuka Abdominal Pain Pharmaceutical Drug Ineffective Company, Ltd. ORAL Started on Dysuria 30mg Hepatic Steatosis mid-Jan/Reduc Nausea ed to 15mg Ovarian Cyst one month Postmenopausal Abilify Tabs 30 Mg SS Otsuka Haemorrhage Pharmaceutical Renal Pain Company, Ltd. ORAL Started on Suicidal Ideation 30mg Urinary Retention mid-Jan/Reduc Urinary Tract Infection ed to 15mg Vomiting one month Weight Increased Haldol C Prempro C 22-Feb-2006 08:31 AM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Restoril C Spironolactone C Klonopin C Amiodarone C Date:04/15/03ISR Number: 4090513-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204178 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Abilify Tabs 15 Mg PS Otsuka Other Cardiac Arrest Pharmaceutical Fatigue Company, Ltd. ORAL Started on Myocardial Infarction 5mg/increased to 10mg/increase d to 15mg on 7 WK Haloperidol Decanoate C "On for several years" Artane C "On for several years" Losartan C "On for several years" Propranolol C "on for several years"/In Aug-2002, dosage was Ibuprofen C "On for several years" Fluticasone C Vitamin E C Multivitamin C Hydrochlorothiazide C Date:04/16/03ISR Number: 4091656-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12223764 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Health Abilify Tabs 10 Mg PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL One dose taken either on 23-Mar-2003 or 1 DAY Effexor C Taken 2 to 3 days before starting aripiprazole 22-Feb-2006 08:31 AM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/03ISR Number: 4093703-2Report Type:Direct Company Report #CTU 191091 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Abilify 15mg PS ORAL PO ONCE/DAY Initial or Prolonged Head Injury Lexapro C Lethargy Klonopin C Muscle Rigidity Trazodone C Pallor Pupillary Reflex Impaired Pupils Unequal Tremor Date:04/16/03ISR Number: 4096116-2Report Type:Direct Company Report #CTU 191109 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Abilify 15mg PS ORAL PO 1 QD Pharyngolaryngeal Pain Pyrexia Rash Date:04/16/03ISR Number: 4096122-8Report Type:Direct Company Report #CTU 191112 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Abilify PS 20 MG QAM AND Initial or Prolonged Drug Ineffective 10MG QHS Dystonia Pain In Jaw Date:04/17/03ISR Number: 4095208-1Report Type:Direct Company Report #CTU 191141 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Abilify 20mg PS ORAL 20MG PO Initial or Prolonged Urinary Incontinence Date:04/18/03ISR Number: 4092999-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12226569 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Abilify PS Otsuka Face Oedema Pharmaceutical Hypersensitivity Company, Ltd. ORAL 1 tablet 1 DAY Throat Irritation Date:04/18/03ISR Number: 4096253-2Report Type:Direct Company Report #CTU 191279 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Aripipzazole Initial or Prolonged Tongue Oedema (Abilify) PS [~2WKS (INTERMITTANT ) 2 WK Concerta C 22-Feb-2006 08:31 AM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/03ISR Number: 4096496-8Report Type:Direct Company Report #CTU 191378 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Ability 10mg Initial or Prolonged Bms-Otsuka PS Bms-Otsuka 10MG ONCE DAILY Seroquel 200mg Asta Zeneca SS Astra Zeneca 800MG PER DAY Valproic Acid C Haloperidol C Date:04/22/03ISR Number: 4096500-7Report Type:Direct Company Report #CTU 191380 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Abilify PS ORAL 45MG PO QD Initial or Prolonged Condition Aggravated PRIOR TO Delusion ADMISSION Grand Mal Convulsion Tequin Hallucination (Gatifloxacin) SS ORAL 400MG PO Psychiatric Symptom -RECEIVED 2 DOSES W/IN 13 HOURS Date:04/23/03ISR Number: 4095649-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-10658300 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Blinded: Wrist Fracture Professional Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Lorazepam C Norvasc C Milk Of Magnesia C Bisacodyl C Tears Naturale C Acetaminophen C Docusate Calcium C Date:04/23/03ISR Number: 4096111-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12233607 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Aripiprazole PS Otsuka Initial or Prolonged Head Injury Professional Pharmaceutical Vertigo Company, Ltd. ORAL Patient received only one dose. Quetiapine C Lorazepam C Temazepam C 22-Feb-2006 08:31 AM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/03ISR Number: 4097416-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12228235 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Abdominal Pain Pharmaceutical Other Asthma Company, Ltd. ORAL Started on Drug Ineffective 30mg Hepatic Steatosis mid-Jan/Reduc Influenza ed to 15mg Menstruation Irregular one month Nausea Abilify Tabs 30 Mg SS Otsuka Renal Pain Pharmaceutical Suicidal Ideation Company, Ltd. ORAL Started on Urinary Retention 30mg Urinary Tract Infection mid-Jan/Reduc Vomiting ed to 15mg Weight Increased one month White Blood Cell Count Haldol C Increased Prempro C Lithium C Restoril C Spironolactone C Klonopin C Amiodarone C Benadryl C Amantadine C Neurontin C Date:04/25/03ISR Number: 4097423-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12244372 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Verbigeration Pharmaceutical Company, Ltd. ORAL Started on 15mg 2wks ago, 22.5mg for 1wk, and 30 mg for one Date:04/28/03ISR Number: 4101317-0Report Type:Direct Company Report #CTU 191774 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Unilateral Abilify PS ORAL PO 4 WK Initial or Prolonged Gait Disturbance Seroquel C Movement Disorder Klonopin C Aricept C Lexapro C Date:04/28/03ISR Number: 4101901-4Report Type:Direct Company Report #CTU 191747 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erection Increased Abilify 15 Mg PS ORAL ORAL QD Clozaril C Klonopin C 22-Feb-2006 08:31 AM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/03ISR Number: 4104545-3Report Type:Direct Company Report #CTU 191896 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alopecia Abilify-Otsuka Intervention to Chemical Burn Of Skin America And Bristol Prevent Permanent Decreased Appetite Myers Squibb PS Otsuka America And Impairment/Damage Dermatitis Exfoliative Bristol Myers Squibb ORAL 20MG ORAL Diarrhoea Depakote SS Erythema Remeron C Fatigue Wellbutrin C Myalgia Lorazepam C Nausea Oral Mucosal Exfoliation Pyrexia Skin Exfoliation Stomatitis Date:04/30/03ISR Number: 4103731-6Report Type:Direct Company Report #CTU 191979 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify 15mg Otsuka PS Otsuka ORAL 15MG QD ORAL Initial or Prolonged Aspartate Abilify 30mg Otsuka SS Otsuka ORAL 30MG QD ORAL Aminotransferase Paxil C Increased Lacrilube C Blood Bilirubin Increased Propanolol C Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Communication Disorder Diplopia Hyperhidrosis Hypertonia Impaired Work Ability Masked Facies Movement Disorder Muscle Rigidity Suicidal Ideation Tremor Date:05/02/03ISR Number: 4105543-6Report Type:Direct Company Report #CTU 192189 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Abilify PS Life-Threatening Geodon 60 Mg Tid SS Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/03ISR Number: 4102913-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12250247 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:05/06/03ISR Number: 4106635-8Report Type:Direct Company Report #CTU 192333 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Abilify 15 Mg Initial or Prolonged Dystonia Otsuka PS Otsuka ORAL 15 MG Q DAY Required Tremor ORAL Intervention to Haldol 5 Mg/1 Ml Prevent Permanent Mylan SS Mylan INTRAMUSCULAR 2.5 MG / 5/2 Impairment/Damage IM / INTRAMUSCULAR Buspar C Miralax C Zoloft C Mvi C Date:05/06/03ISR Number: 4106686-3Report Type:Direct Company Report #CTU 192376 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify 15mg Initial or Prolonged Aspartate Otsuka PS Otsuka ORAL 15 MG QD Aminotransferase ORAL Increased Abilify 30mg Blood Bilirubin Increased Otsuka SS Otsuka ORAL 30MG QD Blood Creatine ORAL Phosphokinase Increased Paxil C Blood Creatine Lacrilube C Phosphokinase Mb Propranolol C Increased Communication Disorder Condition Aggravated Diplopia Hyperhidrosis Hypertonia Hypokinesia Impaired Work Ability Masked Facies Muscle Rigidity Speech Disorder Suicidal Ideation Tremor Date:05/09/03ISR Number: 4106579-1Report Type:Direct Company Report #CTU 192643 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Aripiprazole 15mg PS ORAL 15MG PO QD Initial or Prolonged Sertraline SS ORAL 150 MG PO QD 22-Feb-2006 08:31 AM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/03ISR Number: 4106740-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12181277 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 15 Mg PS Otsuka Other Lung Infection Pharmaceutical Company, Ltd. ORAL Zyprexa C 30 mg (start date not reported)decr eased to 20 mg/day Synthroid C Depakote C 500 mg AM; 1500 mg at hour of sleep Celexa C Date:05/09/03ISR Number: 4110735-6Report Type:Direct Company Report #CTU 192632 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Abilify 10 Mg Initial or Prolonged Condition Aggravated Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 0.5 - 1 TID Delusion ORAL Drug Ineffective Nacom C Hallucination Comtess C Malnutrition Madopar C Parkinson'S Disease Monoembolex C Weight Decreased Date:05/13/03ISR Number: 4108169-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217824 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Aripiprazole PS Otsuka Hospitalization - Fall Professional Pharmaceutical Initial or Prolonged Hip Fracture Company, Ltd. ORAL Interrupted on 19-Mar-2003. Furosemide SS Trazodone Hcl SS Apothecon Isosorbide SS Zestril SS Levothyroxine C Potassium C Date:05/13/03ISR Number: 4112733-5Report Type:Direct Company Report #CTU 192871 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Abilify 10mg Required Difficulty In Walking Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 10MG HS Intervention to Parkinsonism ORAL Prevent Permanent Tardive Dyskinesia Ambien C Impairment/Damage Phenytoin C Paxil C Ibuprofen C Docusate C 22-Feb-2006 08:31 AM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/03ISR Number: 4109454-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12016549 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Aripiprazole PS Otsuka Fall Pharmaceutical Laceration Company, Ltd. ORAL Acute phase unblinded, pt took placebo. Open-label 2 mg from Placebo SS ORAL Acute phase unblinded, pt took placebo. Open-label 2 mg from Trazodone Hcl SS Apothecon ORAL Flurosamide C Multivitamin C Ecotrin C Vitamin E C Exelon C Zocor C Tylenol C Polysporin C TOPICAL Claritin C ORAL Date:05/14/03ISR Number: 4114099-3Report Type:Direct Company Report #CTU 193034 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify PS 10 MG -- HS 4 WK Nausea Retching Vomiting Date:05/19/03ISR Number: 4110743-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224267 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Decreased Pharmaceutical Company, Ltd. ORAL Started 15 mg on 19-Dec-2002, increased to 30 mg on Seroquel C Tapering doses of 27-Jan-03 500mg hs,10-Feb-03 Vitamin E C ORAL 22-Feb-2006 08:31 AM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/03ISR Number: 4114490-5Report Type:Direct Company Report #CTU 193281 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Disorder Aripiprazole Hospitalization - Confusional State (Abilify) PS Bristol-Myers/Otsuka 15-30 MG Initial or Prolonged Depression PILLS, 1 TIME Required Headache A DAY Intervention to Hypomania Prevent Permanent Laceration Impairment/Damage Mania Nightmare Overdose Psychotic Disorder Date:05/20/03ISR Number: 4111876-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12161220 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hypersensitivity Pharmaceutical Company, Ltd. ORAL 10 DAY Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 DAY Serzone C Bristol-Myers Squibb Company Colace C Reglan C Vistaril C Trazodone Hcl Tabs C Apothecon Depo-Provera C Protonix C Multivitamin C Calcium + Vitamin D C Date:05/20/03ISR Number: 4111877-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12250247 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Liver Function Test Pharmaceutical Abnormal Company, Ltd. ORAL Seroquel C Antidepressant C Date:05/21/03ISR Number: 4112618-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274122 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Tachycardia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Reported as 15mg taken once 1 DAY 22-Feb-2006 08:31 AM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/03ISR Number: 4118050-1Report Type:Direct Company Report #CTU 193612 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Abilify 15mg Otsuka PS Otsuka ORAL 15MG QHS Initial or Prolonged Confusional State ORAL Dehydration Fluoxentine 20mg SS ORAL 60MG QD ORAL Delirium Lithium C Disorientation Ecasa C Eating Disorder Wellbutrin Sr C Fall Synthroid C Gait Disturbance Plavix C Medication Error Toprol Xl C Musculoskeletal Stiffness Haloperidol C Speech Disorder Tremor Date:05/22/03ISR Number: 4113931-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12277455 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Abilify Tabs 20 Mg PS Otsuka Hallucination, Auditory Professional Pharmaceutical Physical Assault Company, Ltd. ORAL Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Haldol C Ativan C Date:05/28/03ISR Number: 4116683-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12278156 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify Tabs 15 Mg PS Otsuka Headache Pharmaceutical Hypersensitivity Company, Ltd. ORAL Patient took Muscle Rigidity 2 doses Rash Dexedrine C 10 YR Paxil C 2 YR Claritin C Date:05/28/03ISR Number: 4117066-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281218 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Abilify PS Otsuka Above Therapeutic Pharmaceutical Drug Interaction Company, Ltd. No information reported Clozaril I No information reported 22-Feb-2006 08:31 AM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4119358-6Report Type:Direct Company Report #CTU 194263 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify Required Laryngospasm (Aripiprazole) PS 15 MG "0" Intervention to Opisthotonus Effexor Xl C Prevent Permanent Swollen Tongue Impairment/Damage Torticollis Date:05/29/03ISR Number: 4119388-4Report Type:Direct Company Report #CTU 194252 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Psychomotor Retardation Abilify 15 PS ORAL 15 MG PO Q AM Intervention to Sexual Dysfunction Prevent Permanent Impairment/Damage Date:05/29/03ISR Number: 4120878-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12133229 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Aripiprazole PS Otsuka Depressed Level Of Pharmaceutical Consciousness Company, Ltd. ORAL Restlessness Risperdal C Thought Broadcasting Date:05/29/03ISR Number: 4120879-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12140927 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Abilify Tabs 10 Mg PS Otsuka Dyskinesia Pharmaceutical Ear Discomfort Company, Ltd. ORAL Headache Abilify Tabs 10 Mg SS Otsuka Hyperhidrosis Pharmaceutical Muscle Twitching Company, Ltd. ORAL Nasal Congestion Seroquel C Nausea Lithium C Rhinorrhoea Prevacid C Throat Tightness Cardizem C Toothache Zanaflex C Wellbutrin C Date:05/29/03ISR Number: 4120880-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12143434 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify Tabs 15 Mg PS Otsuka Pruritus Pharmaceutical Company, Ltd. ORAL Interrupted on 23-Dec-2003. Restarted at reduced dose Zyprexa SS 22-Feb-2006 08:31 AM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Inderal C Zantac C Date:05/29/03ISR Number: 4120881-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12150272 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Somnolence Company, Ltd. ORAL Ambien C Depakote C Prevacid C Xanax C Fish Oil C Date:05/29/03ISR Number: 4120882-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12158440 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Aspartate Pharmaceutical Aminotransferase Company, Ltd. ORAL 1 WK Increased Depakote C 500 mg in the Blood Creatine morning, 1000 Phosphokinase Increased mg in the Disturbance In Attention evening Headache Wellbutrin C Muscle Tightness Myalgia Neck Pain Neuroleptic Malignant Syndrome Toothache Date:05/29/03ISR Number: 4120883-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12172045 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 5 DAY Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Lithium C Paxil C Adderall C 22-Feb-2006 08:31 AM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120884-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173225 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Drooling Pharmaceutical Dysphasia Company, Ltd. ORAL Dose Fatigue increased to Sedation 30 mg/day during the week of 06 Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose increased to 30 mg/day during the week of 06 Haldol C Depakote C 250 mg one in the AM and two at hour of sleep. Paxil C Date:05/29/03ISR Number: 4120885-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12173530 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify Tabs 10 Mg PS Otsuka Restlessness Pharmaceutical Somnolence Company, Ltd. ORAL Patient reported on 07-Mar-03 that he was taking 20 mg Vitamin C Date:05/29/03ISR Number: 4120886-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174116 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs 5 Mg PS Otsuka Restlessness Pharmaceutical Somnolence Company, Ltd. ORAL Klonopin C Date:05/29/03ISR Number: 4120887-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174132 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 5 mg/increased to 7.5mg after 4 wks/10mg Abilify Tabs SS Otsuka 22-Feb-2006 08:31 AM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL Started on 5 mg/increased to 7.5mg after 4 wks/10mg Zoloft C Klonopin C Date:05/29/03ISR Number: 4120888-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174405 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Extrapyramidal Disorder Pharmaceutical Other Company, Ltd. ORAL Accidental ingestion of six 10 mg tablets. Date:05/29/03ISR Number: 4120889-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174462 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Insipidus Abilify PS Otsuka Pharmaceutical Company, Ltd. No dosage, dates or frequency provided/on medication 3 MON Depakote C 1 YR Lithium C 1 YR Date:05/29/03ISR Number: 4120890-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174710 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 15 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL "put on hold" on 02 Feb 02 Delsym SS Celexa C On hold as of 02 Feb 03 Effexor C On hold as of 02 Feb 03 Date:05/29/03ISR Number: 4120891-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174751 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Abilify Tabs 15 Mg PS Otsuka Eyelid Disorder Pharmaceutical Photosensitivity Reaction Company, Ltd. ORAL Zoloft C Amantadine C Ortho Tri-Cyclen C 22-Feb-2006 08:31 AM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120892-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175071 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C 3 YR Depakote C 11 YR Trazodone Hcl C Apothecon 10 YR Seroquel C 2 YR Unithroid C Sonata C Date:05/29/03ISR Number: 4120893-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175097 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Irritability Pharmaceutical Judgement Impaired Company, Ltd. ORAL Date:05/29/03ISR Number: 4120894-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175113 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. 3 WK Glucovance C Bristol-Myers Squibb Company Avandia C Date:05/29/03ISR Number: 4120895-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175220 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Exact dates and frequency not provided Date:05/29/03ISR Number: 4120896-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175428 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 15 Mg PS Otsuka Headache Pharmaceutical Heart Rate Increased Company, Ltd. ORAL Increased to Hostility 15mg two Insomnia tablets/daily Nausea on 03 Feb 03. Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 15mg two tablets/daily 22-Feb-2006 08:31 AM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report on 03 Feb 03. Date:05/29/03ISR Number: 4120897-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175618 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify PS Otsuka Dyspnoea Pharmaceutical Epistaxis Company, Ltd. ORAL Feeling Abnormal Depakote C Somnolence Weight Increased Date:05/29/03ISR Number: 4120898-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12175733 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Anxiety Pharmaceutical Excitability Company, Ltd. ORAL Insomnia Clonazepam C Micturition Urgency Wellbutrin C Pollakiuria Lexapro C Psychomotor Hyperactivity Multivitamin C Pyridium Plus C Lupron Depot C Monthly injections Date:05/29/03ISR Number: 4120899-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12176012 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs 15 Mg PS Otsuka Balance Disorder Pharmaceutical Constipation Company, Ltd. ORAL Dose reduced Diarrhoea to 1/2 tab Fall every other Fatigue day/then to Food Intolerance 1/2 tab on 1 MON Insomnia Zantac C Nausea Zoloft C Visual Disturbance Wellbutrin C Weight Decreased Xanax C Tums C Nexium C Levoxyl C Lithium C Clozaril C Date:05/29/03ISR Number: 4120900-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12177846 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. Exact dates not provided, on the 22-Feb-2006 08:31 AM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report medication approximately Date:05/29/03ISR Number: 4120901-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12177887 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Serzone Tabs PS Bristol-Myers Squibb Somnolence Company ORAL Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120902-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12180204 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Somnolence Pharmaceutical Company, Ltd. ORAL 5 DAY Premarin C Provera C Exelon C Lopressor C Vitamin C C Multivitamin C Date:05/29/03ISR Number: 4120903-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12181335 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL Topamax C Clozapine C Lisinopril C Merck Research Labs Wellbutrin C Adderall C Date:05/29/03ISR Number: 4120904-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12181541 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Cold Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120905-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12182218 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120906-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12182275 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 MON Zyprexa C Date:05/29/03ISR Number: 4120907-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12182291 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL No exact dates provided Date:05/29/03ISR Number: 4120908-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12182325 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120909-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12182374 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120910-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12182994 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Abilify PS Otsuka Initial or Prolonged Abnormal Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120911-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12183612 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided Nexium C 22-Feb-2006 08:31 AM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Lipitor C Depakote C Ambien C Date:05/29/03ISR Number: 4120912-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12183620 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Abilify Tabs 5 Mg PS Otsuka Social Avoidant Behaviour Pharmaceutical Tardive Dyskinesia Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Norvasc C Triamterene C Diazepam C Moban C Date:05/29/03ISR Number: 4120913-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12183679 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervous System Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/29/03ISR Number: 4120914-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12183745 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify Tabs 30 Mg PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL No exact Aminotransferase dates Increased provided. 16 DAY Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL No exact dates provided. 16 DAY Depakote C Indapamide C Levothroid C Glipizide C Lantus C Date:05/29/03ISR Number: 4120915-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12183778 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs PS Otsuka Dizziness Pharmaceutical Hypoaesthesia Company, Ltd. ORAL 15mg for 2 days/then 30mg for 2 22-Feb-2006 08:31 AM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report days/interrup ted 07-09Feb. Clozaril C Vistaril C Prolixin C Apothecon Cogentin C Date:05/29/03ISR Number: 4120916-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12184750 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Maternal Drugs Affecting Abilify Tabs 30 Mg PS Otsuka Foetus Pharmaceutical Normal Newborn Company, Ltd. ORAL Pregnancy Date:05/29/03ISR Number: 4120917-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185237 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs 15 Mg PS Otsuka Haematochezia Pharmaceutical Company, Ltd. ORAL Takes half of a 15 mg tablet. Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Takes half of a 15 mg tablet. Wellbutrin Sr C Date:05/29/03ISR Number: 4120918-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185419 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Abilify Tabs PS Otsuka Somnolence Pharmaceutical Vomiting Company, Ltd. ORAL No exact dates provided Date:05/29/03ISR Number: 4120919-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185500 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Titrated up to 30 mg/day Date:05/29/03ISR Number: 4120920-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185518 Age:45 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Akathisia 22-Feb-2006 08:31 AM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Pressure Increased Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose reduced to 10 mg/day (date not reported) Clozaril C 600 to 800 mg/day Date:05/29/03ISR Number: 4120921-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185534 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 30 Mg PS Otsuka Blood Pressure Increased Pharmaceutical Heart Rate Increased Company, Ltd. ORAL Dose Restlessness decreased to 15 mg/day, then discontinued Clozaril C 500-600 mg/day Date:05/29/03ISR Number: 4120922-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185567 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs 30 Mg PS Otsuka Heart Rate Increased Pharmaceutical Company, Ltd. Date:05/29/03ISR Number: 4120923-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185575 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Blood Pressure Increased Pharmaceutical Delusion Company, Ltd. ORAL dose reduced Irritability to 10 mg/day Restlessness (date not reported) Date:05/29/03ISR Number: 4120924-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185583 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Trileptal C 22-Feb-2006 08:31 AM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120925-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185591 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril C Date:05/29/03ISR Number: 4120926-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185633 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Physician had altered dose of Abilify and discontinued Trileptal C Clonidine C Date:05/29/03ISR Number: 4120927-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12186326 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL increased from 7.5 mg/day Depakote SS Avandia C Ativan C Zyprexa C Date:05/29/03ISR Number: 4120928-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12186342 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Hytrin C Lanoxin C Zestril C Fibercon C Ocuvite C Muro 128 C Ativan C Combivent C Albuterol C Xalatan C Prednisolone C Nicoderm C Prevacid C Humibid L.A. C 22-Feb-2006 08:31 AM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120929-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12186375 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Risperdal C Depakote C Albuterol C Blood Pressure Medication C Hydrocodone C Date:05/29/03ISR Number: 4120930-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12186664 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 10 mg tablet Klonopin C Date:05/29/03ISR Number: 4120931-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12187134 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:05/29/03ISR Number: 4120932-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12187654 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Myoclonus Pharmaceutical Company, Ltd. ORAL 15 mg on 03Jan03; increased to 30 mg on 03Feb03; Seroquel C Celexa C Date:05/29/03ISR Number: 4120933-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12187696 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril C 22-Feb-2006 08:31 AM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120934-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12187860 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restless Legs Syndrome Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor Xr C Seroquel C Restoril C Date:05/29/03ISR Number: 4120935-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12188207 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. Started medication "middle of Dec 2002" Pamelor C Klonopin C Ditropan C Celebrex C Enbrel C Date:05/29/03ISR Number: 4120936-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12188256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Dysuria Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120937-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12188678 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Cogentin C Date:05/29/03ISR Number: 4120938-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12188900 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Neurontin C Zoloft C Seroquel C Tapering down 22-Feb-2006 08:31 AM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120939-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12189270 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify Tabs 15 Mg PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL Aminotransferase Zoloft C Increased Depakote C Eosinophil Count Zantac C Increased White Blood Cell Count Increased Date:05/29/03ISR Number: 4120940-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12190450 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120941-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12190484 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120942-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12190872 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs PS Otsuka Headache Pharmaceutical Nervousness Company, Ltd. Date:05/29/03ISR Number: 4120943-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12190955 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL stopped, restarted at 5 mg/day on 19Feb03 Contraceptive C Seroquel C Date:05/29/03ISR Number: 4120944-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12191383 Age:40 YR Gender:Female I/FU:I Outcome PT Dissociation Dizziness 22-Feb-2006 08:31 AM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dry Mouth Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Date:05/29/03ISR Number: 4120945-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12191458 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120946-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12191490 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C Xanax C Date:05/29/03ISR Number: 4120947-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12191516 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120948-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12192985 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120949-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12193322 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Muscular Weakness Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120950-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12193462 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120951-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194221 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C No information provided. Date:05/29/03ISR Number: 4120952-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194254 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 15 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL Exact dates not provided Date:05/29/03ISR Number: 4120953-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194338 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120954-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194700 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120955-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194734 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Exact dates not provided 22-Feb-2006 08:31 AM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120956-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194759 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Verapamil C Synthroid C Paxil C Vitamin C C Vitamin B Complex C Detrol C Date:05/29/03ISR Number: 4120957-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194841 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify Tabs PS Otsuka Diarrhoea Pharmaceutical Nausea Company, Ltd. ORAL Date:05/29/03ISR Number: 4120958-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194858 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120959-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12194957 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4120960-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12195335 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Abilify Tabs PS Otsuka Headache Pharmaceutical Insomnia Company, Ltd. ORAL increased to 10 mg daily on 9-Feb-2003 and then to 15 mg daily Trazodone Hcl Tabs C Apothecon ORAL at bedtime 22-Feb-2006 08:31 AM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120961-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12195426 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 3 DAY Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Date:05/29/03ISR Number: 4120962-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12195590 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 15 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL Exact dates not provided. Date:05/29/03ISR Number: 4120963-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12196051 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Celexa C Date:05/29/03ISR Number: 4120964-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12196069 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Increased Pharmaceutical Aspartate Company, Ltd. ORAL Exact dates Aminotransferase not provided Increased Seroquel C Dose Neuroleptic Malignant increased Syndrome from 400 mg. Syncope Exact dates not provided. Klonopin C Date:05/29/03ISR Number: 4120965-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12196341 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK 22-Feb-2006 08:31 AM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120966-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12196374 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120967-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12196416 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK Date:05/29/03ISR Number: 4120968-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12196721 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Thyroid Preparation C Date:05/29/03ISR Number: 4120969-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12196929 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120970-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12197026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Insulin C Lithium C Date:05/29/03ISR Number: 4120971-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12198255 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Belligerence Pharmaceutical Insomnia Company, Ltd. ORAL Supplemental Paranoia information from 25-Mar-03:dos 22-Feb-2006 08:31 AM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report e was Date:05/29/03ISR Number: 4120972-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12198297 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120973-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12198313 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL at bedtime Topamax C Valium C Date:05/29/03ISR Number: 4120974-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12198347 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120975-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12198354 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify Tabs 15 Mg PS Otsuka Lethargy Pharmaceutical Company, Ltd. ORAL 3 DAY Prozac C 2 DAY Date:05/29/03ISR Number: 4120976-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12199097 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120977-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12199105 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify Tabs PS Otsuka Anorexia Pharmaceutical Insomnia Company, Ltd. ORAL started 15mg Respiratory Rate samples from Increased 07-Feb-03 to Restlessness 14-Feb-03, Weight Decreased then 22-Feb-2006 08:31 AM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL started 15mg samples from 07-Feb-03 to 14-Feb-03, then Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL started 15mg samples from 07-Feb-03 to 14-Feb-03, then Sinequan C Ambien C Multivitamins C Vitamin B1 C Vitamin B12 C Vitamin C C Date:05/29/03ISR Number: 4120978-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12199121 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Walking Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Benadryl SS Pt taking up to 100 mg hs since 03-Feb-03, pt never taken Geodon C Risperdal C Haldol C Cogentin C Clonazepam C Date:05/29/03ISR Number: 4120979-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12199410 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL dose was "5mg 1/2 of a tab" Date:05/29/03ISR Number: 4120980-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120981-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200671 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Date:05/29/03ISR Number: 4120982-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200804 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Date:05/29/03ISR Number: 4120983-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200853 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify Tabs PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL Reported as "15-30 mg"/no dates provided. Date:05/29/03ISR Number: 4120984-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200879 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Date:05/29/03ISR Number: 4120985-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200945 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Abilify Tabs 15 Mg PS Otsuka Oedema Peripheral Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120986-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200994 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Disorder Abilify Tabs 15 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Started 15mg daily on 16-Jan-03,the n increased to 15mg twice Topamax C St John Wort C 22-Feb-2006 08:31 AM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120987-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12201349 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Stelazine C Vitamins C Date:05/29/03ISR Number: 4120988-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12201836 Age:5 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Abilify PS Otsuka Syncope Pharmaceutical Company, Ltd. No information provided. 1 WK Date:05/29/03ISR Number: 4120989-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12202719 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120990-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12203295 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs 15 Mg PS Otsuka Joint Swelling Pharmaceutical Company, Ltd. ORAL Serzone Tabs C Bristol-Myers Squibb Company Buspar Tabs C Bristol-Myers Squibb Company Date:05/29/03ISR Number: 4120991-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12203832 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Klonopin C Amaryl C Actos C Nexium C 22-Feb-2006 08:31 AM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120992-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12203873 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient started therapy in the past week at 15mg Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Patient started therapy in the past week at 15mg Date:05/29/03ISR Number: 4120993-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12203915 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120994-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204087 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify Tabs PS Otsuka Mania Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120995-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204210 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120996-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204525 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify Tabs PS Otsuka Initial or Prolonged Extrapyramidal Disorder Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL No dosage or exact dates provided 22-Feb-2006 08:31 AM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120997-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204533 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Exact dates not provided Date:05/29/03ISR Number: 4120998-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204608 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4120999-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204673 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Xanax C Sonata C Date:05/29/03ISR Number: 4121000-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204756 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 9 DAY Effexor C Klonopin C Xanax C Date:05/29/03ISR Number: 4121001-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12205696 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121002-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206108 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL started 10mg day for 2 days,then increased to 15mg day for 2 WK 22-Feb-2006 08:31 AM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL started 10mg day for 2 days,then increased to 15mg day for 2 WK Wellbutrin C 150 mg in the morning and 150 mg (crushed) in the evening Clonidine C Ativan C Klonopin C Topamax C Famotidine C Slow-K C Atenolol C Apothecon Maxzide C Ketoconazole C CUTANEOUS Date:05/29/03ISR Number: 4121003-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206165 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL No information on dosage or dates provided Zyprexa C Date:05/29/03ISR Number: 4121004-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206207 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Abilify Tabs 15 Mg PS Otsuka Face Oedema Pharmaceutical Headache Company, Ltd. ORAL 1 DAY Paraesthesia Zoloft C Clonazepam C Date:05/29/03ISR Number: 4121005-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206454 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Abilify PS Otsuka Initial or Prolonged Oedema Peripheral Pharmaceutical Psychotic Disorder Company, Ltd. ORAL No information provided 22-Feb-2006 08:31 AM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121006-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206686 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Abilify Tabs PS Otsuka Drooling Pharmaceutical Dystonia Company, Ltd. ORAL 2 MON Seroquel C 2 MON Date:05/29/03ISR Number: 4121007-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12206801 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 10 Mg PS Otsuka Vomiting Pharmaceutical Weight Increased Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Clonidine C Date:05/29/03ISR Number: 4121008-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12207189 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Heart Rate Increased Pharmaceutical Nausea Company, Ltd. ORAL "took 1/2 of a 15 mg tablet" Lorazepam C Haldol C Neurontin C Date:05/29/03ISR Number: 4121009-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12208260 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121010-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12208393 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121011-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12208690 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. No information provided Date:05/29/03ISR Number: 4121012-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12208708 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pulmonary Embolism Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121013-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12208716 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL daily at bedtime, started on 06-Mar-2003 or Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL daily at bedtime, started on 06-Mar-2003 or Date:05/29/03ISR Number: 4121014-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12209599 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertonia Abilify Tabs 15 Mg PS Otsuka Pain In Jaw Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121015-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12209888 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121016-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12210258 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs PS Otsuka Feeling Abnormal Pharmaceutical Insomnia Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121017-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12210449 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121018-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12210969 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Seroquel C Klonopin C Date:05/29/03ISR Number: 4121019-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12211017 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121020-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12211207 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121021-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12211314 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121022-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12211330 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activities Of Daily Abilify Tabs 15 Mg PS Otsuka Living Impaired Pharmaceutical Feeling Abnormal Company, Ltd. ORAL Started dose at 15 mg, then was decreased to 7.5 mg 22-Feb-2006 08:31 AM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121023-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12211538 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Feeling Jittery Pharmaceutical Insomnia Company, Ltd. ORAL took 1-15 mg tablet since 07-Mar-03, took 1/2 tablet on Glucotrol Xl C Glucophage C Bristol-Myers Squibb Company Date:05/29/03ISR Number: 4121024-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212189 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Body Temperature Abilify Tabs PS Otsuka Increased Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121025-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212205 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Nardil C Date:05/29/03ISR Number: 4121026-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212221 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify Tabs 20 Mg PS Otsuka Chest Pain Pharmaceutical Vomiting Company, Ltd. ORAL taken since end of Nov-2002/begi nning of Dec-2002 Date:05/29/03ISR Number: 4121027-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212247 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Tension Company, Ltd. ORAL Zyprexa C 5 DAY Symmetrel C Effexor C Aricept C 22-Feb-2006 08:31 AM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121028-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212825 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121029-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212882 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121030-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212999 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Prozac C Zyprexa C Date:05/29/03ISR Number: 4121031-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12213567 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121032-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12214557 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 15 Mg PS Otsuka Hallucination Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Began in an Insomnia increasing Mood Swings dosage-now at Weight Decreased 15 mg bid. Clozaril C Tapering off from 1/28/03- 2/28/03 Lopressor C Wellbutrin C Vitamin B12 C Prilosec C Multivitamin C Calcium C Contraceptive C ORAL 22-Feb-2006 08:31 AM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121033-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12214813 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Back Pain Company, Ltd. ORAL 4 WK Restlessness Sensory Disturbance Date:05/29/03ISR Number: 4121034-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12214821 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 20 Mg PS Otsuka Constipation Pharmaceutical Impatience Company, Ltd. ORAL started 20 mg Irritability dose for over Restlessness 4 weeks, then decided to reduce dose 4 WK Date:05/29/03ISR Number: 4121035-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12214839 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121036-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12215042 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activated Partial Abilify Tabs PS Otsuka Thromboplastin Time Pharmaceutical Prolonged Company, Ltd. ORAL 4 WK Prothrombin Time Thorazine C Prolonged Date:05/29/03ISR Number: 4121037-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12215075 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify Tabs PS Otsuka Mood Swings Pharmaceutical Company, Ltd. ORAL Zoloft SS Dose decreased to 25mg Date:05/29/03ISR Number: 4121038-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12215588 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL started Abilify 20 mg 4 to 5 months ago-about 1 month ago, Lithium C Foltx C Date:05/29/03ISR Number: 4121039-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12215604 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C No dosage reported Haldol C No dosage or exact date reported Zyprexa C No dosage or exact date reported Date:05/29/03ISR Number: 4121040-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12215679 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eating Disorder Abilify Tabs 30 Mg PS Otsuka Extrapyramidal Disorder Pharmaceutical Pollakiuria Company, Ltd. ORAL Started on Syncope 15mg Tachycardia increased to 30mg on 27-Feb-2003 Lamictal C Adderall C Benadryl C PRN for approximately one week prior to event Cogentin C PRN for approximately one week prior to event Date:05/29/03ISR Number: 4121041-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12215745 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided 22-Feb-2006 08:31 AM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121042-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12215943 Age:5 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify Tabs 30 Mg PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL Started on 15mg/increase d to 30mg in less than 1 week/stopped Tricor SS Seroquel C 400 TO 600 MG/No dates provided Geodon C Date:05/29/03ISR Number: 4121043-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217451 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121044-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217931 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Exelon C Capoten C Apothecon Inderal C Date:05/29/03ISR Number: 4121045-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12218343 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Swelling Abilify Tabs PS Otsuka Rash Papular Pharmaceutical Company, Ltd. ORAL duration: "several days." Date:05/29/03ISR Number: 4121046-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12218350 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Fatigue Pharmaceutical Somnolence Company, Ltd. No information was provided except on medication 3 WK Micronase C 22-Feb-2006 08:31 AM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121047-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12218731 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify Tabs 15 Mg PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL 10 DAY Zoloft C Lorazepam C Exact dates not reported but this was reportedly not a new Cogentin C Discontinued on admission to psychiatric facility Amantadine C Discontinued on admission to psychiatric facility Date:05/29/03ISR Number: 4121048-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12218921 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs 15 Mg PS Otsuka Oligomenorrhoea Pharmaceutical Company, Ltd. ORAL Consumer taking 1/2 of a 15 mg tablet to equal 7.5 mg 2 WK Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Consumer taking 1/2 of a 15 mg tablet to equal 7.5 mg 2 WK Anafranil C Lexapro C Date:05/29/03ISR Number: 4121049-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12218947 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neurological Symptom Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121050-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12219291 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs 15 Mg PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Patient started Abilify 10 mg daily in Jan-03,increa Colace C Benadryl C Ativan C Tylenol C Milk Of Magnesia C Date:05/29/03ISR Number: 4121051-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12219838 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Trihexyphenidyl SS Trihexyphenidyl SS Seroquel C Lithium C Prevacid C Cardizem C Zanaflex C Wellbutrin C Date:05/29/03ISR Number: 4121052-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12220463 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:05/29/03ISR Number: 4121053-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12220646 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Cozaar C Bristol-Myers Squibb Company Hydrochlorothiazide C Niacin C Date:05/29/03ISR Number: 4121054-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12221008 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs PS Otsuka Mood Altered Pharmaceutical Speech Disorder Company, Ltd. ORAL Started 15mg 22-Feb-2006 08:31 AM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dec-02,then 1 wk ago, dose increased to 1-15mg tab + 1 WK Risperdal SS Depakote C Cogentin C Date:05/29/03ISR Number: 4121055-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12221057 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 15 Mg PS Otsuka Ejaculation Failure Pharmaceutical Insomnia Company, Ltd. ORAL 5 DAY Male Orgasmic Disorder Nausea Pyrexia Sluggishness Visual Disturbance Date:05/29/03ISR Number: 4121056-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12221453 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril SS Patient was withdrawn from Clozaril when Abilify was started. Date:05/29/03ISR Number: 4121057-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12221503 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 14-Mar-03: 7.5mg/day x 4 days, to 15mg daily on 18-Mar-03, to Lexapro C Date:05/29/03ISR Number: 4121058-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12222709 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient started on Abilify 15 mg and dose increased to 22-Feb-2006 08:31 AM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozaril SS Date:05/29/03ISR Number: 4121059-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12222717 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 20 Mg PS Otsuka Insomnia Pharmaceutical Restlessness Company, Ltd. ORAL Dose reduced to 15 mg daily on 23-Mar-2003 Date:05/29/03ISR Number: 4121060-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12222774 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flight Of Ideas Abilify Tabs 15 Mg PS Otsuka Nervousness Pharmaceutical Restlessness Company, Ltd. ORAL Klonopin C Date:05/29/03ISR Number: 4121061-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12223061 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Abilify PS Otsuka Dyspnoea Pharmaceutical Muscle Spasms Company, Ltd. No information reported Date:05/29/03ISR Number: 4121062-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12223079 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121063-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12223913 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Anxiety Pharmaceutical Restlessness Company, Ltd. ORAL Date:05/29/03ISR Number: 4121064-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224002 Age:6 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Abilify Tabs 15 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL at bedtime 1 WK 22-Feb-2006 08:31 AM Page: 102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121065-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224150 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Engorgement Abilify Tabs PS Otsuka Breast Pain Pharmaceutical Breast Tenderness Company, Ltd. ORAL Began 5mg daily on 25-Feb-03,the n increased to 10mg,then Paxil C Haldol C Levoxyl C Klonopin C Depakote C Ativan C Concerta C Ambien C Date:05/29/03ISR Number: 4121066-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224226 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121067-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224267 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Abilify Tabs PS Otsuka Decreased Pharmaceutical Company, Ltd. ORAL Started 15 mg on 19-Dec-2002, increased to 30 mg on Seroquel C Tapering doses of 27-Jan-03 500mg hs,10-Feb-03 Vitamin E C Date:05/29/03ISR Number: 4121068-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224754 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121069-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12225017 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Adderall C Prozac C Date:05/29/03ISR Number: 4121070-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12225033 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 10 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121071-6Report Type:Periodic Company Report #PR-BRISTOL-MYERS SQUIBB COMPANY-12225322 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 10 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121072-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12225348 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 15 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Wellbutrin C Zoloft C Date:05/29/03ISR Number: 4121073-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12225355 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Abilify Tabs PS Otsuka Unexpected Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121074-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12225652 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL dosing 22-Feb-2006 08:31 AM Page: 104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report information not known Haldol C Cogentin C Date:05/29/03ISR Number: 4121075-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12225686 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Phosphokinase Increased Company, Ltd. ORAL Reported as Rhabdomyolysis 15 mg tablet/takes 1/2 tablet daily Lamictal SS Lorazepam C Ambien C Benzodiazepines C Vistaril C Neurontin C Limbitrol C Prednisone C Vioxx C Xanax C Hydrochlorothiazide C Aciphex C Skelaxin C Dulcolax C Vicodin C Date:05/29/03ISR Number: 4121076-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12226007 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Initial Insomnia Pharmaceutical Muscle Spasms Company, Ltd. ORAL Nervousness Lexapro C "at night" Restlessness Benadryl C Vitamin E C Vitamin B Complex C Multivitamin C Date:05/29/03ISR Number: 4121077-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12226346 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121078-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12226460 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121079-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12227195 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5 mg (1/2 of a 15 mg tablet) once a day Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5 mg (1/2 of a 15 mg tablet) once a day Date:05/29/03ISR Number: 4121080-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12227252 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121081-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12228029 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Concerta C Zantac C Donnatal C Cimetidine C Miralax C Date:05/29/03ISR Number: 4121082-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12228599 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Synthroid C Lantus C 22-Feb-2006 08:31 AM Page: 106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humalog C Altace C Date:05/29/03ISR Number: 4121083-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12228888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Loxepin C Date:05/29/03ISR Number: 4121084-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12228904 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started "3 weeks ago" 3 WK Date:05/29/03ISR Number: 4121085-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12228953 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:05/29/03ISR Number: 4121086-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12229456 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Drug Ineffective Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121087-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12229696 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify Tabs 20 Mg PS Otsuka Blood Pressure Increased Pharmaceutical Company, Ltd. ORAL Started on 10mg/Increase d to 15mg on 07-Mar/Increa sed to 20mg Lithobid C reported as 900-1200 mg daily Neurontin C reported as 100 mg 2-3 times daily Restoril C reported as 22-Feb-2006 08:31 AM Page: 107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PRN Ativan C reported as 0.5mg QID for "some weeks before" but had been Date:05/29/03ISR Number: 4121088-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12230017 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pollakiuria Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121089-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12230132 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121090-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12230413 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Postmenopausal Abilify Tabs PS Otsuka Haemorrhage Pharmaceutical Company, Ltd. ORAL started Abilify 15 mg daily about 4-6 wks ago,increased Methadone C Mirapex C Premarin C Provera C Synthroid C Azathioprine C Date:05/29/03ISR Number: 4121091-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12230447 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flight Of Ideas Abilify Tabs PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL therapy initiated "about one month ago" 22-Feb-2006 08:31 AM Page: 108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121092-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12230637 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neck Pain Abilify Tabs 15 Mg PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL taken at bedtime Paxil C Strattera C Date:05/29/03ISR Number: 4121093-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12230645 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL taken since 11/2002 or 12/2002 4 MON Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL taken since 11/2002 or 12/2002 4 MON Date:05/29/03ISR Number: 4121094-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12231726 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthritis Abilify Tabs PS Otsuka Psoriasis Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121095-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12231759 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121096-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12231825 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Enuresis Pharmaceutical Sleep Disorder Company, Ltd. ORAL Once in evening. Beginning of Feb-03:dose to 7.5mg qd. Depakote C Clonidine C Neurontin C 22-Feb-2006 08:31 AM Page: 109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121097-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12231940 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:05/29/03ISR Number: 4121098-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12232658 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs 15 Mg PS Otsuka Rhinorrhoea Pharmaceutical Company, Ltd. ORAL Multivitamin C Date:05/29/03ISR Number: 4121099-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12232690 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL after one week, dosage increased to 15 mg daily 03-Apr-03. Effexor C Klonopin C Tegretol C Date:05/29/03ISR Number: 4121100-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12232716 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121101-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12232724 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Diane-35 C Date:05/29/03ISR Number: 4121102-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12232872 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Heart Rate Increased Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Toprol Xl C 22-Feb-2006 08:31 AM Page: 110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Effexor C Date:05/29/03ISR Number: 4121103-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12233227 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Swelling Abilify Tabs 15 Mg PS Otsuka Oedema Peripheral Pharmaceutical Swelling Face Company, Ltd. ORAL Serax C Trazodone Hcl C Apothecon Date:05/29/03ISR Number: 4121104-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12233235 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify Tabs 15 Mg PS Otsuka Dizziness Pharmaceutical Head Banging Company, Ltd. ORAL 2 DAY Hyperhidrosis Klonopin C Insomnia Restlessness Syncope Visual Disturbance Date:05/29/03ISR Number: 4121105-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12234944 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL started 7.5 mg bid, then 30 mg daily, then 45 mg daily Risperidone C Date:05/29/03ISR Number: 4121106-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12235198 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121107-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12236485 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urine Amphetamine Abilify Tabs 30 Mg PS Otsuka Positive Pharmaceutical Company, Ltd. ORAL Patient started 15 mg daily on 22-Feb-2006 08:31 AM Page: 111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 05-Feb-2003, increased to Zyprexa C Celexa C Trazodone Hcl C Apothecon Depakote C Sonata C Wellbutrin C Date:05/29/03ISR Number: 4121108-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12236493 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121109-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12236600 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Agitation Pharmaceutical Breast Pain Company, Ltd. ORAL 06-07-Apr-03, Constipation pt took 15 mg Decreased Appetite 1/4 tab in Dizziness afternoon & Dysgeusia 1/2 tab in Emotional Disorder Haldol C Fatigue Lorazepam C Headache Tegretol C Hunger Cogentin C Hyperacusis Lamictal C Hypoaesthesia Buspar C Bristol-Myers Squibb Nasopharyngitis Company Nausea Axert C Retching Sinus Headache Somnolence Date:05/29/03ISR Number: 4121110-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12237236 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Abilify Tabs PS Otsuka Discomfort Pharmaceutical Somnolence Company, Ltd. ORAL Started "approximatel y 3 weeks ago". 3 WK Celexa C Lithium C 22-Feb-2006 08:31 AM Page: 112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121111-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12237244 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glossitis Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121112-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238069 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL dose decreased to 7.5 mg (1/2 tablet) once a day Luvox C Date:05/29/03ISR Number: 4121113-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238457 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121114-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238481 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3/10/03, started on 10mg & increased to 15mg qd on Methocarbamol C Inderal La C Wellbutrin Sr C Seroquel C Lisinopril C Merck Research Labs Tylenol #3 C Claritin C Ritalin C Date:05/29/03ISR Number: 4121115-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238903 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started 15 mg daily on 01-Mar-03,inc 22-Feb-2006 08:31 AM Page: 113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report reased to 30 mg daily on Depakote C Colace C Levothyroxine C Lithium C Multivitamin C Quetiapine C Clonapam C Amantadine C started during hospitalizati on Aspirin C Date:05/29/03ISR Number: 4121116-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238911 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 15mg qd on 14-Mar-03,inc reased to 20mg daily on 28-Mar.Decrea Multivitamin C Zoloft C Sulindac C Sildenafil C Date:05/29/03ISR Number: 4121117-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238929 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Catapres C Zoloft C Topamax C Dexedrine C Date:05/29/03ISR Number: 4121118-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238937 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs PS Otsuka Back Pain Pharmaceutical Myalgia Company, Ltd. ORAL consumer took Posture Abnormal "35-50 mg" once daily since 26-Feb-2003. Remeron C Acetaminophen C taken for many years Maalox C taken for most of his 22-Feb-2006 08:31 AM Page: 114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report adult life Date:05/29/03ISR Number: 4121119-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12239166 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Abilify Tabs 15 Mg PS Otsuka Influenza Like Illness Pharmaceutical Vision Blurred Company, Ltd. ORAL 2 WK Lithium C Risperdal C Xanax C Date:05/29/03ISR Number: 4121120-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12239174 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Abilify Tabs 15 Mg PS Otsuka Decreased Pharmaceutical Company, Ltd. ORAL 2 MON Date:05/29/03ISR Number: 4121121-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12239984 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Restlessness Company, Ltd. ORAL Weight Decreased Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Trileptal C Clonazepam C Date:05/29/03ISR Number: 4121122-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12240537 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify Tabs 15 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL at bedtime Wellbutrin C Date:05/29/03ISR Number: 4121123-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12240826 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Abilify Tabs PS Otsuka Dysarthria Pharmaceutical Somnolence Company, Ltd. ORAL 2 WK 22-Feb-2006 08:31 AM Page: 115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121124-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12240925 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Nervousness Pharmaceutical Weight Increased Company, Ltd. ORAL On 15mg daily for "3 weeks" 3 WK Depakote C Trileptal C Date:05/29/03ISR Number: 4121125-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12240941 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs 15 Mg PS Otsuka Dyskinesia Pharmaceutical Hypomania Company, Ltd. ORAL 1 DAY Date:05/29/03ISR Number: 4121126-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12241550 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121127-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12241568 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Topamax C Zestril C Detrol C Date:05/29/03ISR Number: 4121128-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12241857 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceutical Thinking Abnormal Company, Ltd. ORAL Norvasc C Digitek C Spironolactone C Tracleer C Neurontin C Lorazepam C 22-Feb-2006 08:31 AM Page: 116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121129-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12241899 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Prozac C Remeron C Cardura C Date:05/29/03ISR Number: 4121130-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12242954 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Abilify Tabs PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121131-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12242970 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Dehydration Pharmaceutical Other Diarrhoea Company, Ltd. ORAL Patient Nausea taking 1/4 of Vomiting 15mg tab./Exact dates not 2 WK Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Patient taking 1/4 of 15mg tab./Exact dates not 2 WK Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Patient taking 1/4 of 15mg tab./Exact dates not 2 WK Date:05/29/03ISR Number: 4121132-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12243036 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Ocular Hyperaemia Pharmaceutical Vision Blurred Company, Ltd. ORAL Zyprexa C 22-Feb-2006 08:31 AM Page: 117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121133-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12244273 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify Tabs 15 Mg PS Otsuka Laryngitis Pharmaceutical Oedema Peripheral Company, Ltd. ORAL Unknown starting dosage/Starte d on the 15 mg on Date:05/29/03ISR Number: 4121134-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12244299 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Florinef C King Pharmaceutical Inc. Florinef C King Pharmaceutical Inc. Date:05/29/03ISR Number: 4121135-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12244315 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify Tabs 15 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Aricept C Date:05/29/03ISR Number: 4121136-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12244570 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121137-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12244976 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Abilify Tabs 10 Mg PS Otsuka Increased Pharmaceutical Malaise Company, Ltd. ORAL Patient taking 1/4 of a 10 mg tablet/starte d within the Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Patient taking 1/4 of a 10 mg tablet/starte 22-Feb-2006 08:31 AM Page: 118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report d within the Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Patient taking 1/4 of a 10 mg tablet/starte d within the Date:05/29/03ISR Number: 4121138-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245056 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL 1 WK Date:05/29/03ISR Number: 4121139-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245098 Age:8 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Date:05/29/03ISR Number: 4121140-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245221 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. No information provided Antidepressant C Date:05/29/03ISR Number: 4121141-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245338 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify Tabs 15 Mg PS Otsuka Fatigue Pharmaceutical Nausea Company, Ltd. ORAL Patient takes Somnolence 1/4 of a 15 mg tablet in the morning Klonopin C PRN-rarely needed now Vitamins Multiple C Vitamin B Complex C Vitamin C C Omega 3 Fatty Acid C Beta Carotene C Calcium C 22-Feb-2006 08:31 AM Page: 119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121142-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245379 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical Somnolence Company, Ltd. ORAL Started on 3.75mg daily/increas ed to 7.5mg daily(unrelat Adderall C ORAL Reported as Adderall XR 5 mg one time Multivitamin C Vitamin C C Beta Carotene C Date:05/29/03ISR Number: 4121143-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245387 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 DAY Ritalin C Date:05/29/03ISR Number: 4121144-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245403 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started 15 mg daily in Jan-03, decreased to 10 mg daily Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started 15 mg daily in Jan-03, decreased to 10 mg daily Date:05/29/03ISR Number: 4121145-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12245932 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Depakote C Topamax C Clonidine C Thyroid Supplement C 22-Feb-2006 08:31 AM Page: 120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121146-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246401 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 WK Date:05/29/03ISR Number: 4121147-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246468 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Abilify Tabs PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121148-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246476 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Tylenol C Tums C Mvi C Surfak C Provera C Premarin C Mom C Senokot C Date:05/29/03ISR Number: 4121149-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246518 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 10 Mg PS Otsuka Drug Level Increased Pharmaceutical Mania Company, Ltd. ORAL Started on 7.5mg daily/reduced to 3.25mg daily for 2 Depakote C Date:05/29/03ISR Number: 4121150-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246666 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Seroquel C Valproic Acid C Haldol C 22-Feb-2006 08:31 AM Page: 121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121151-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246716 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Synthroid C Lexapro C Tegretol C Date:05/29/03ISR Number: 4121152-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246732 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Abilify PS Otsuka Pharmaceutical Company, Ltd. dosing information not reported Zyprexa C Effexor C Synthroid C Klonopin C Depakote C Atenolol C Apothecon Tri-Chlor C Lipitor C Date:05/29/03ISR Number: 4121153-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246815 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 tablet between 5 and 7 pm with food 8 DAY Date:05/29/03ISR Number: 4121154-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246823 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL started 5mg daily on 14-Apr-03 to 18-Apr-03,the n 10mg daily Geodon C Effexor C Cogentin C 22-Feb-2006 08:31 AM Page: 122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121155-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246856 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Abilify Tabs 30 Mg PS Otsuka Thinking Abnormal Pharmaceutical Company, Ltd. ORAL Started on 10 mg daily for one month/increas ed to 30 mg 2 MON Digoxin C Toprol Xl C Seroquel C Date:05/29/03ISR Number: 4121156-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12247292 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS Otsuka Initial or Prolonged Cardio-Respiratory Arrest Pharmaceutical Company, Ltd. ORAL Exact dosage not reported/took 1-3 tablets 1 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Exact dosage not reported/took 1-3 tablets 1 DAY Depakote C Neurontin C Navane C ORAL 2 TABLETS at bedtime Inderal C Geodon C Tranxene C Zocor C Dyazide C Synthroid C Allegra C PRN Celebrex C as needed Date:05/29/03ISR Number: 4121157-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12248241 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Date:05/29/03ISR Number: 4121158-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12249322 Age:72 YR Gender:Female I/FU:I Outcome PT Aspartate Aminotransferase 22-Feb-2006 08:31 AM Page: 123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Alkaline Phosphatase Blood Sodium Decreased Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started 10 mg daily for 2 weeks, then increased dose to 15 mg Zoloft C Lasix C Neurontin C Glipizide C Clozapine C has been taking for years Date:05/29/03ISR Number: 4121159-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12249389 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 8 DAY Depakote C Paxil C Synthroid C Date:05/29/03ISR Number: 4121160-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12249439 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Nausea Pharmaceutical Retching Company, Ltd. ORAL Started in the beginning of April Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started in the beginning of April Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started in the beginning of April Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started in the beginning of April Depakote C Luvox C Cogentin C Inderal La C Nexium C Ambien C 22-Feb-2006 08:31 AM Page: 124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol C Xanax C Centrum Silver C Date:05/29/03ISR Number: 4121161-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12249454 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Saliva Altered Pharmaceutical Vomiting Company, Ltd. ORAL Taking the medication for the past 2 months/Exact Prozac C Cogentin C Risperdal C Prolixin C Apothecon Date:05/29/03ISR Number: 4121162-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12252029 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL At bedtime. Started 3 weeks ago 3 WK Nexium C Multivitamin C Daily Date:05/29/03ISR Number: 4121163-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12252078 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs 15 Mg PS Otsuka Cardiac Flutter Pharmaceutical Diarrhoea Company, Ltd. ORAL Disturbance In Attention Zyprexa C Memory Impairment Centrum Silver C Nausea Vision Blurred Date:05/29/03ISR Number: 4121164-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12252334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121165-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12252920 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Headache Pharmaceutical Insomnia Company, Ltd. ORAL Nausea Sedation Date:05/29/03ISR Number: 4121166-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12252938 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Anxiety Pharmaceutical Headache Company, Ltd. ORAL 10 mg/day Hypomania from Panic Disorder 18-Mar-2003 until 07-Apr-2003, Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg/day from 18-Mar-2003 until 07-Apr-2003, Wellbutrin Sr SS Vitamin E C Lamictal C Trazodone Hcl C Apothecon Inderal La C Premarin C Vitamin C C Valtrex C Date:05/29/03ISR Number: 4121167-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12252995 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eczema Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/29/03ISR Number: 4121168-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12253027 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Somnolence Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121169-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12253852 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Started "8 weeks prior to drug released on market"/Dose Lexapro C Started 3 weeks ago Date:05/29/03ISR Number: 4121170-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12253860 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Vitamins C Date:05/29/03ISR Number: 4121171-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12254033 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4121172-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12254710 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Abilify Tabs 15 Mg PS Otsuka Muscle Twitching Pharmaceutical Company, Ltd. ORAL Depakote C Celexa C Risperdal C Date:05/29/03ISR Number: 4121173-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12254801 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Pharmaceutical Company, Ltd. No information provided 22-Feb-2006 08:31 AM Page: 127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121174-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12254819 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Date:05/29/03ISR Number: 4121175-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12255030 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121176-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12255097 Age:6 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 15 mg for a few days/increase d to 30 mg/no exact dates Neurontin C Date:05/29/03ISR Number: 4121177-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12256160 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Patient took one tablet/exact dose not reported Premarin C ORAL On for a "long time" Lopid C ORAL On for 1 year Effexor C ORAL 2 Tablets daily/on since last week Remeron C ORAL Taken a bedtime/on for 1 month Date:05/29/03ISR Number: 4121178-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12257010 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. No 22-Feb-2006 08:31 AM Page: 128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report information provided Date:05/29/03ISR Number: 4121179-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12257226 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Drug Ineffective Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121180-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12257242 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Vitamins C Date:05/29/03ISR Number: 4121181-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12257259 Age:8 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:05/29/03ISR Number: 4121182-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12257770 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Started on 7.5mg/Increas ed to 15 mg on 15-Mar-2003 Risperdal C ORAL Started on 7.5 mg/Increased to 7.5-9 mg every morning Depakote C ORAL Topamax C ORAL Benztropine C ORAL Prosom C ORAL 1 to 2 mg at hour of sleep Prometrium C ORAL Given 12 days/month Lotensin C 22-Feb-2006 08:31 AM Page: 129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121183-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12259032 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Abilify Tabs 30 Mg PS Otsuka Abnormal Pharmaceutical Company, Ltd. ORAL Ritalin C Dexedrine Spansule C Date:05/29/03ISR Number: 4121184-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12259073 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4121185-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12259206 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hunger Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL Topamax C Wellbutrin C Lexapro C Fish Oil C Aspirin C Ginkgo Biloba C Vitamins C Lamictal C Date:05/29/03ISR Number: 4121186-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12259255 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Craving Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil Cr C Concerta C Date:05/29/03ISR Number: 4121187-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12259339 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 15 mg tablet per day 22-Feb-2006 08:31 AM Page: 130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4121188-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12260030 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4121189-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12260048 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. No information provided Date:05/29/03ISR Number: 4121190-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12260089 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Drooling Pharmaceutical Fatigue Company, Ltd. ORAL Irritability Strattera C Lethargy Topamax C Date:05/29/03ISR Number: 4121191-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12260154 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril C taken at bedtime Klonopin C taken at bedtime Metamucil C Date:05/29/03ISR Number: 4121192-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12260188 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 30 Mg PS Otsuka Agitation Pharmaceutical Chest Pain Company, Ltd. ORAL Patient takes Coordination Abnormal 1/2 of a 30 Gait Disturbance mg tablet. Gastric Disorder Exact dates Muscle Tightness not reported. Palpitations Lorazepam C Vomiting Zyprexa C Lisinopril C Merck Research Labs Artane C 22-Feb-2006 08:31 AM Page: 131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tylenol C Date:05/29/03ISR Number: 4121193-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12273751 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs 20 Mg PS Otsuka Skin Ulcer Pharmaceutical Company, Ltd. ORAL Started product 5 months ago. 5 MON Ativan C Lithobid C Date:05/30/03ISR Number: 4119142-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280178 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Tachycardia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Haldol C Ativan C Date:05/30/03ISR Number: 4119168-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12278990 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Abilify Tabs 15 Mg PS Otsuka Drug Level Increased Pharmaceutical Salivary Hypersecretion Company, Ltd. ORAL Risperidone C ORAL Klonopin C ORAL Depo-Provera C INTRAMUSCULAR Last injection about 3 weeks ago-early March Date:05/30/03ISR Number: 4119558-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12278990 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Abilify Tabs 15 Mg PS Otsuka Drug Level Increased Pharmaceutical Medication Error Company, Ltd. ORAL Salivary Hypersecretion Risperidone C ORAL Klonopin C ORAL Depo-Provera C INTRAMUSCULAR Last injection about 3 weeks ago-early March 22-Feb-2006 08:31 AM Page: 132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/03ISR Number: 4119676-1Report Type:Direct Company Report #CTU 194367 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Abilify 15 Mg Intervention to Speech Disorder Started 12/11/02 PS WELLBUTRIN Prevent Permanent Tongue Disorder FOR 2 DAYS Impairment/Damage ONLY SIDE EFFECTS CONTINUED Lexapro 10 Mg Previously Since 11/19/02 SS Date:05/30/03ISR Number: 4119681-5Report Type:Direct Company Report #CTU 194368 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Abilify 15mg PS 15 MG ONLY Psychomotor Hyperactivity 1/4 TABLET Restless Legs Syndrome Neurontin C Ativan C Estrogen Replacement Bi Estrogen & Progesterone C Date:05/30/03ISR Number: 4119682-7Report Type:Direct Company Report #CTU 194369 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify 15 Mg Po PS Restlessness Effexor Xr C Strattera C Seroquel C Klonopin C Date:06/02/03ISR Number: 4120290-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12269916 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Confusional State Pharmaceutical Depressed Level Of Company, Ltd. ORAL Consciousness Diarrhoea Disorientation Hallucination Influenza Like Illness Muscle Rigidity Nausea Pyrexia Restlessness Stupor Tachycardia Trichotillomania Urinary Incontinence Vomiting 22-Feb-2006 08:31 AM Page: 133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4121308-3Report Type:Direct Company Report #CTU 194425 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Ablify 15 Mg PS ORAL 15 MG ONCE Drooling ORAL DAILY Dysarthria Enuresis Feeling Abnormal Lethargy Tremor Vision Blurred Date:06/04/03ISR Number: 4122541-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282497 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Ischaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. No information reported Klonopin C Haldol C Depakote C Date:06/04/03ISR Number: 4123057-4Report Type:Direct Company Report #CTU 194939 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify 15 Mg PS 1 DAILY Nausea Abilify 10 Mg SS 1 DAILY Staring Vision Blurred Vomiting Weight Decreased Date:06/05/03ISR Number: 4123628-5Report Type:Direct Company Report #CTU 195076 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Abilify 5mg PS 1ST DOSE Fall Loss Of Consciousness Respiratory Rate Increased Date:06/05/03ISR Number: 4123725-4Report Type:Direct Company Report #CTU 195059 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Abilify 10 Mg PS ORAL 10 MG DAILY ORAL 22-Feb-2006 08:31 AM Page: 134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/03ISR Number: 4123695-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12224747 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Abilify PS Otsuka Initial or Prolonged Cellulitis Pharmaceutical Other Dysphagia Company, Ltd. ORAL Started on Fall 20mg/Reduced Gait Disturbance to 15 mg Musculoskeletal Stiffness exact date Sedation not Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 20mg/Reduced to 15 mg exact date not Aricept C Remeron C Hydrochlorothiazide C Colace C Levoxyl C Multivitamin C Date:06/09/03ISR Number: 4124406-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12287546 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Atrial Fibrillation Pharmaceutical Other Blood Creatine Company, Ltd. ORAL Phosphokinase Increased Abilify Tabs 15 Mg SS Otsuka Bradycardia Pharmaceutical Coma Company, Ltd. ORAL Convulsion Abilify Tabs 15 Mg SS Otsuka Electrocardiogram Qt Pharmaceutical Prolonged Company, Ltd. ORAL Hypotension Abilify Tabs 15 Mg SS Otsuka Overdose Pharmaceutical Respiratory Arrest Company, Ltd. ORAL Tic Effexor C Zantac C Lexapro C Date:06/10/03ISR Number: 4127123-9Report Type:Direct Company Report #CTU 195534 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Abilify PS Otsuka America Intervention to Syndrome Pharmaceutical/Brist Prevent Permanent ol-Myers ORAL 20 MG QD PO Impairment/Damage 22-Feb-2006 08:31 AM Page: 135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/03ISR Number: 4126164-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291282 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Abilify PS Otsuka Liver Function Test Pharmaceutical Abnormal Company, Ltd. No information provided Date:06/11/03ISR Number: 4127067-2Report Type:Direct Company Report #CTU 195606 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify 15mg PS ORAL ONCE QAM PO Atrial Tachycardia Risperdal 1.5mg SS ORAL ONCE QHS PO Condition Aggravated Dyspnoea Palpitations Panic Attack Restlessness Date:06/12/03ISR Number: 4127460-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12287546 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Atrial Fibrillation Pharmaceutical Other Blood Creatine Company, Ltd. ORAL Phosphokinase Increased Abilify Tabs 15 Mg SS Otsuka Bradycardia Pharmaceutical Coma Company, Ltd. ORAL Convulsion Abilify Tabs 15 Mg SS Otsuka Electrocardiogram Qrs Pharmaceutical Complex Prolonged Company, Ltd. ORAL Electrocardiogram Qt Abilify Tabs 15 Mg SS Otsuka Prolonged Pharmaceutical Hypotension Company, Ltd. ORAL Overdose Effexor C Respiratory Arrest Zantac C Lexapro C Date:06/13/03ISR Number: 4127757-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12290995 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Cogentin C ORAL Restoril C Zoloft C 22-Feb-2006 08:31 AM Page: 136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/03ISR Number: 4128768-2Report Type:Direct Company Report #CTU 195762 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Abilify PS ORAL 10 MG PO QD Intervention to Musculoskeletal Stiffness Paxil Cr C Prevent Permanent Clonidine C Impairment/Damage Topamox C Strattera C Seroquel C Date:06/17/03ISR Number: 4129927-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12185823 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Abilify Tabs 15 Mg PS Otsuka Coronary Artery Professional Pharmaceutical Atherosclerosis Company, Ltd. ORAL Loss Of Consciousness Serzone C Bristol-Myers Squibb Medication Error Company ORAL Pulmonary Congestion Effexor Xr C Lorazepam C Remeron C Risperdal C Date:06/17/03ISR Number: 4130568-4Report Type:Direct Company Report #CTU 195974 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Abilify/Otsuka Of Hospitalization - Syndrome Bristol Myers Squibb PS Bristol Myers Squibb Initial or Prolonged Rhabdomyolysis Metoprolol C Required Dyazide C Intervention to Lipitor C Prevent Permanent Vasotec C Impairment/Damage Asa C Darvocet C Niaspan C Date:06/18/03ISR Number: 4130740-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12295200 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Fall Pharmaceutical Haematuria Company, Ltd. ORAL Interrupted Hypothermia (date not Lethargy reported); Somnolence restarted on 04-Jun-2003 Klonopin C Neurontin C Magnesium Oxide C Os-Cal + D C Protonix C Reglan C Detrol La C Claritin C 22-Feb-2006 08:31 AM Page: 137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/03ISR Number: 4131106-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12152492 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Abilify Tabs 15 Mg PS Otsuka Hospitalization - Agitation Professional Pharmaceutical Initial or Prolonged Blood Glucose Increased Company, Ltd. ORAL 1 MON Disability Coma Zyprexa C Drug Toxicity Encephalopathy Hyperammonaemia Insomnia International Normalised Ratio Decreased Miosis Restlessness Somnolence Date:06/19/03ISR Number: 4132454-2Report Type:Direct Company Report #CTU 196221 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Aripipirazole 15 Mg PS ORAL 15 MG PO QD/ Initial or Prolonged Chills 1 DOSE Somnolence Adderall C Valproic Acid C Date:06/20/03ISR Number: 4132227-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12297453 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Dyskinesia Pharmaceutical Dystonia Company, Ltd. ORAL Patient took Laryngospasm only one dose Cocaine C Patient had taken the drug within 24 hours of admission Date:06/20/03ISR Number: 4132233-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12296679 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify Tabs 30 Mg PS Otsuka Fall Pharmaceutical Fear Company, Ltd. ORAL Intentional Self-Injury Irritability Morbid Thoughts Restlessness Screaming Stupor Suicidal Ideation Tremor 22-Feb-2006 08:31 AM Page: 138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/03ISR Number: 4132984-3Report Type:Direct Company Report #CTU 196226 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Abilify 10mg PS OTHER 2.5MG / AM OTHER Eskalith Cr C Lamictal C Abilify C Date:06/23/03ISR Number: 4133308-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-10494284 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Blinded: Complete Aripiprazole PS Otsuka Blood Pressure Decreased Pharmaceutical Myocardial Infarction Company, Ltd. ORAL Citalopram C Lorazepam C Date:06/24/03ISR Number: 4133872-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12216685 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Interrupted-n o date provided Date:06/25/03ISR Number: 4134720-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281218 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Abilify PS Otsuka Above Therapeutic Pharmaceutical Dizziness Company, Ltd. No Drug Interaction information Orthostatic Hypotension reported Clozaril I No information reported Date:06/25/03ISR Number: 4135155-XReport Type:Direct Company Report #CTU 196563E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify PS Bristol-Myers Squibb Initial or Prolonged Agitation Co. ORAL 15MG HS ORAL Delusion Zyprexa C Insomnia Topamax C Mania Maxzide C Speech Disorder 22-Feb-2006 08:31 AM Page: 139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/03ISR Number: 4135161-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12301636 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify Tabs 10 Mg PS Otsuka Laryngospasm Pharmaceutical Muscle Spasms Company, Ltd. ORAL Throat Tightness Celexa C 8 MON Trismus Septra Ds C 8 MON Multivitamin With Minerals C Vitamin E C Folic Acid C Date:06/25/03ISR Number: 4135203-7Report Type:Direct Company Report #CTU 196582 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Abilify 10 Mg PS 1/2 TABLET ON Intervention to Discomfort 3/18 Prevent Permanent Dizziness DECREASED TO Impairment/Damage Irritability 1/4 DOSE ON Muscle Twitching 3/20 Sensation Of Heaviness Prozac C Tinnitus Avelox C Date:06/25/03ISR Number: 4135205-0Report Type:Direct Company Report #CTU 196583 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Abilify 20 Mg PS 1/2 TAB QHS Intervention to Drug Ineffective Seroquel C Prevent Permanent Restless Legs Syndrome Wellbutrin Sr C Impairment/Damage Reminyl C Synthroid C Date:06/27/03ISR Number: 4136416-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12302212 Age:8 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient had received two doses Date:06/30/03ISR Number: 4138171-7Report Type:Direct Company Report #CTU 196889 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Abilify PS ORAL 15 MG PO QD Initial or Prolonged Liver Function Test Niacin C Abnormal Levoxyl C Mental Status Changes Asa C Nausea Lipitor C Vomiting Lorazepam C Neurontin C Benztropine C 22-Feb-2006 08:31 AM Page: 140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Enalapril C Avandia C Date:07/01/03ISR Number: 4138917-8Report Type:Direct Company Report #CTU 196964 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Abilify PS ORAL 15MG QD ORAL Initial or Prolonged Liver Function Test Niacin C Abnormal Lipitor C Mental Status Changes Levoxyl C Nausea Asa C Vomiting Lorazepam C Neurontin C Benztropine C Enalapril C Avandia C Date:07/02/03ISR Number: 4139437-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12216636 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Abilify Tabs 15 Mg PS Otsuka Other Psychotic Disorder Pharmaceutical Treatment Noncompliance Company, Ltd. ORAL 1 DAY Depakote C Lithium C Risperdal C Provigil C Protriptyline C Glucophage C Bristol-Myers Squibb Company Benadryl C Caffeine C Date:07/03/03ISR Number: 4141758-9Report Type:Direct Company Report #CTU 197216 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Torticollis Aripiprazole 15mg PS ORAL 15MG QD ORAL Minocyclin C Lorazepam C Clonazepam C Venlafaxine C Diphenhydramine C Date:07/07/03ISR Number: 4142246-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12287546 Age:21 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acidosis Initial or Prolonged Atrial Fibrillation Other Blood Creatine Phosphokinase Increased Bradycardia Coma Electrocardiogram Qrs 22-Feb-2006 08:31 AM Page: 141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Complex Prolonged Electrocardiogram Qt Prolonged Hypotension Report Source Product Role Manufacturer Route Dose Duration Overdose Health Abilify Tabs 15 Mg PS Otsuka Pneumonia Aspiration Professional Pharmaceutical Respiratory Arrest Company, Ltd. ORAL Status Epilepticus Abilify Tabs 15 Mg SS Otsuka Suicide Attempt Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Zantac C Lexapro C Date:07/07/03ISR Number: 4142675-0Report Type:Direct Company Report #CTU 197372 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Aripiprazole Intervention to (Abilify) PS ORAL 15 MG QHS PO Prevent Permanent Estrogen C Impairment/Damage Rivastigmine C Ativan C Date:07/09/03ISR Number: 4144020-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12313144 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Other Hallucination, Auditory Pharmaceutical Company, Ltd. 4 WK Date:07/09/03ISR Number: 4144519-XReport Type:Direct Company Report #CTU 197556 Age:36 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Abilify 10 Mg Otsuka PS Otsuka ORAL 10 MG QHS Drug Withdrawal Syndrome ORAL Feeling Abnormal Insulin C Musculoskeletal Stiffness Zocor C Nausea Zestril C Pain Hydrochlorothiazide C Tremor Amitriptyline C Vomiting Date:07/10/03ISR Number: 4144333-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12314241 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Professional Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C Zopiclone C Date:07/10/03ISR Number: 4144689-3Report Type:Direct Company Report #CTU 197620 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Abilify 5mg (Dose Up Muscle Rigidity To 20mg) PS ORAL 5MG(1/15/03), Tremor 10MG (1/18/03),20M G (1/23/02) PO QD Lithium C Senokot C Effexor Xr C Protonix C Tapazole C Detrol C Oscal C Atenolol C Ecasa C Klonopin C Date:07/11/03ISR Number: 4145303-3Report Type:Expedited (15-DaCompany Report #WAES 0306USA01008 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Singulair PS Merck & Co., Inc ORAL Extrapyramidal Disorder Abilify SS Date:07/11/03ISR Number: 4145459-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12312641 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 10 or 15 mg/day Date:07/14/03ISR Number: 4146479-4Report Type:Direct Company Report #CTU 197868 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify 30mg Bristol Initial or Prolonged Asthenia Myers Squibb PS Bristol Myers Squibb Date:07/17/03ISR Number: 4148655-3Report Type:Direct Company Report #CTU 198097 Age:33 YR Gender:Female I/FU:I Outcome PT Required Blood Creatine Intervention to Phosphokinase Prevent Permanent Body Temperature Impairment/Damage Increased Confusional State 22-Feb-2006 08:31 AM Page: 143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Creatinine Urine Drooling Incontinence Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Abilify 10mg Tablets PS ORAL 10MG PO Q HS Tachycardia Clonazepam C Depakote Er C Docusate Sodium C Propranolol C Trazodone C White Petrolatum C Acetaminophen C Haloperidol C Lorazepam C Budesonide Nasal Spray C Tolnaftate Antifungal Powder C Date:07/17/03ISR Number: 4148674-7Report Type:Direct Company Report #CTU 198101 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Abilify PS ORAL 15MG QD PO Somnolence Valproic Acid C Clozapine C Date:07/18/03ISR Number: 4149090-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12320214 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Abilify Tabs 10 Mg PS Otsuka Dyspnoea Exertional Pharmaceutical Hypertension Company, Ltd. ORAL Seasonal Allergy Depakote C 500mg in a.m.; 1250mg at night Date:07/22/03ISR Number: 4151049-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12322798 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Trazodone Hcl C Effexor C Date:07/22/03ISR Number: 4151443-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12312641 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs PS Otsuka Fall Pharmaceutical Company, Ltd. 10 or 15 mg/day 22-Feb-2006 08:31 AM Page: 144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/03ISR Number: 4153736-4Report Type:Direct Company Report #CTU 198620 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Abilify PS 10MG Q AM Life-Threatening Hepatic Failure Depakote SS 500 MG BID Refusal Of Treatment By Haldol C Relative Decanoate C Zyprexa C Neurontin C Artane C Glyburide C Biscodyl C Multivitamin C Gemfibrozil C Captopril C Tylenol C Colace C Vit E C Aricept C Artifical Tears C Sorbitol C Potassium Chloride C Haldol C Albuterol C Lasix C Clobetasol Cream C Dulcolax Supp C Tylenol C Milk Of Mag C Fleets Enema C Date:07/30/03ISR Number: 4157294-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12290961 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify Tabs 15 Mg PS Otsuka Dry Mouth Pharmaceutical Feeling Hot Company, Ltd. ORAL Headache Glucophage Xr Tabs SS Bristol-Myers Squibb Neck Pain Company ORAL 4 YR Restlessness Flonase C Tremor Zoloft C Ortho-Cept C Date:07/30/03ISR Number: 4158923-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330379 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Abilify Tabs 15 Mg PS Otsuka Skin Disorder Pharmaceutical Skin Necrosis Company, Ltd. ORAL Depakote C Pain Medications C Antibiotics C Hctz C 22-Feb-2006 08:31 AM Page: 145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/03ISR Number: 4158928-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330429 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Serotonin Syndrome Pharmaceutical Company, Ltd. ORAL Interrupted on approx 26 or 17-Jul-2003, resumed for Risperdal C Topamax C Effexor C At bedtime Zonegran C Date:07/31/03ISR Number: 4158783-4Report Type:Direct Company Report #CTU 199028 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Dobutamine PS INTRAVENOUS Prolonged DRIP 10MCG/KG/M Ventricular Tachycardia INTRAVENOUS DRIP Aripiprazole -Abilify- 15mg Bristol Myers Squibb SS Bristol Myers Squibb ORAL 15MG QD ORAL Aspirin C Nabumetone C Sertraline C Olanzapine C Pantoprazole C Date:07/31/03ISR Number: 4184903-1Report Type:Periodic Company Report #NSADSS2002043687 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Risperdal Initial or Prolonged Liver Function Test Professional (Risperidone) PS ORAL ORAL Abnormal Aripiprazole Neuroleptic Malignant (Aripiprazole) SS Syndrome Psychotic Disorder Suicidal Ideation Urinary Retention Date:08/01/03ISR Number: 4159228-0Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12330957 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Generalised Aripiprazole PS Otsuka Exanthematous Pustulosis Pharmaceutical Herpes Virus Infection Company, Ltd. ORAL Pyoderma 22-Feb-2006 08:31 AM Page: 146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/03ISR Number: 4159345-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12320214 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Exercise Induced Abilify Tabs 10 Mg PS Otsuka Blood Pressure Increased Pharmaceutical Dehydration Company, Ltd. ORAL Dyspnoea Exertional Depakote C 500mg in Heat Exposure Injury a.m.; 1250mg Seasonal Allergy at night Date:08/01/03ISR Number: 4159346-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282497 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Ischaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. No information reported Klonopin C Haldol C Depakote C Date:08/01/03ISR Number: 4159347-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315826 Age:5 DEC Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Thrombocytopenic Purpura Pharmaceutical Increased Tendency To Company, Ltd. ORAL Started in Bruise Dec-02, Rash discontinued Vaginal Haemorrhage after 2 weeks. Prolixin C Apothecon 20 YR Cogentin C 20 YR Date:08/01/03ISR Number: 4159355-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12331583 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anal Fissure Abilify Tabs PS Otsuka Gastrointestinal Pharmaceutical Haemorrhage Company, Ltd. ORAL Rectal Haemorrhage Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/04/03ISR Number: 4161033-6Report Type:Direct Company Report #CTU 199118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Strattera 40 PS Drug Ineffective Abilify 15 SS Screaming Lamictal 200 SS 22-Feb-2006 08:31 AM Page: 147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/03ISR Number: 4161059-2Report Type:Direct Company Report #CTU 199156 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Abilify 15mg- Bristol Myers Squibb PS Bristol Myers Squibb ORAL 15MG HS PO [PRIOR TO ADMISSION] Depakote Er C Ambien C Date:08/04/03ISR Number: 4186807-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12287462 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify Tabs PS Otsuka Skin Ulcer Pharmaceutical Company, Ltd. ORAL Warfarin Sodium I Bristol-Myers Squibb Company Date:08/06/03ISR Number: 4162954-0Report Type:Expedited (15-DaCompany Report #WAES 0306USA01008 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Singulair PS Merck & Co., Inc ORAL 435 DAY Above Therapeutic Abilify SS 1 WK Drug Interaction Abilify SS 2 DAY Extrapyramidal Disorder Abilify SS Medication Error Abilify SS Date:08/06/03ISR Number: 4163886-4Report Type:Direct Company Report #CTU 199368 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Abilify PS Initial or Prolonged Heart Rate Decreased Prozac SS Loss Of Consciousness Nausea Vomiting Date:08/06/03ISR Number: 4163887-6Report Type:Direct Company Report #CTU 199369 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Abilify PS Initial or Prolonged Extrapyramidal Disorder Tremor Date:08/07/03ISR Number: 4164949-XReport Type:Direct Company Report #CTU 199589 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify PS ORAL PO? Initial or Prolonged Tachycardia 22-Feb-2006 08:31 AM Page: 148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/03ISR Number: 4163899-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12226569 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Abilify PS Otsuka Face Oedema Pharmaceutical Hypersensitivity Company, Ltd. ORAL 1 tablet 1 DAY Medication Error Throat Irritation Date:08/08/03ISR Number: 4166158-7Report Type:Direct Company Report #CTU 199607 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Abilify 20mg Bms PS Bms ORAL 20MG DAILY Hospitalization - Increased ORAL Initial or Prolonged Cardiac Arrest Cefazolin Iv C Coma Furosemide C Fall Nifedipine Xl C Haematemesis Combivir C Oedema Peripheral Percocet C Rash Viramune C Swelling Date:08/13/03ISR Number: 4166616-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12343661 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Abilify Tabs 10 Mg PS Otsuka Unexpected Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/13/03ISR Number: 4167506-4Report Type:Direct Company Report #CTU 199955 Age:13 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS 10MG DAILY Initial or Prolonged Syndrome Lexapro SS 10MG DAILY Topomax C Date:08/14/03ISR Number: 4167962-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12351698 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify Tabs 15 Mg PS Otsuka Dysphagia Pharmaceutical Eye Rolling Company, Ltd. ORAL Hyperhidrosis Abilify Tabs 15 Mg SS Otsuka Insomnia Pharmaceutical Muscle Rigidity Company, Ltd. ORAL Muscle Spasms Effexor C Reported as Parkinsonian Gait taken for "a Swollen Tongue long time". 22-Feb-2006 08:31 AM Page: 149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/03ISR Number: 4168107-4Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12330957 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Generalised Aripiprazole PS Otsuka Exanthematous Pustulosis Pharmaceutical Pyoderma Company, Ltd. ORAL Date:08/15/03ISR Number: 4169931-4Report Type:Direct Company Report #CTU 200109 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Abilify PS 15 MG PO Hunger Stelazine C Hyperhidrosis Cogentin C Lymphadenopathy Valium C Pyrexia Ambien C Urinary Incontinence Colace C Date:08/15/03ISR Number: 4170053-7Report Type:Direct Company Report #CTU 200088 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glycosylated Haemoglobin Abilify 15 Mg PS ORAL 15 MG PO QD Increased Weight Increased Date:08/18/03ISR Number: 4170479-1Report Type:Direct Company Report #CTU 200119 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Lithium Carbonate Dry Mouth Cap 300 Mg Roxane PS Roxane ORAL 1800 MG /DAY Feeling Abnormal TID ORAL Pollakiuria Abilify 15 Mg Polydipsia Novaritis SS Novaritis ORAL 15 MG QD ORAL Respiratory Disorder Tremor Date:08/22/03ISR Number: 4172051-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315826 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Thrombocytopenic Purpura Pharmaceutical Other Increased Tendency To Company, Ltd. ORAL Started in Bruise Dec-02, Iron Deficiency Anaemia discontinued Rash after 2 Splenectomy weeks. Vaginal Haemorrhage Prolixin C Apothecon 22-May-2003: Vision Blurred dose reduced to 5 mg/day 20 YR Cogentin C 20 YR 22-Feb-2006 08:31 AM Page: 150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4173757-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12357315 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify PS Otsuka Fatigue Pharmaceutical Oedema Peripheral Company, Ltd. ORAL Pallor Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Klonopin C Prozac C Date:08/27/03ISR Number: 4173761-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217824 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Aripiprazole PS Otsuka Hospitalization - Fall Pharmaceutical Initial or Prolonged Hip Fracture Company, Ltd. ORAL Blinded 31May2002 to 08Aug2002; Open label 09Aug2002 - Furosemide SS Trazodone Hcl SS Isosorbide SS Zestril SS Levothyroxine C Potassium C Date:08/28/03ISR Number: 4175065-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12278990 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Abilify Tabs 15 Mg PS Otsuka Cardiomegaly Pharmaceutical Pulmonary Congestion Company, Ltd. ORAL Salivary Hypersecretion Risperidone C ORAL Therapeutic Agent Klonopin C ORAL Toxicity Depo-Provera C INTRAMUSCULAR Last injection about 3 weeks ago-early March Date:08/28/03ISR Number: 4175071-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12134813 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Photophobia Company, Ltd. ORAL 1 tablet daily. Geodon C Ativan C Lithium C 22-Feb-2006 08:31 AM Page: 151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175072-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174132 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Constipation Pharmaceutical Depression Company, Ltd. ORAL 5 mg, inc to Dissociation 7.5mg; Fatigue decrease to Influenza Like Illness 15mg - Nausea 30Jan03, inc Weight Increased Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg, inc to 7.5mg; decrease to 15mg - 30Jan03, inc Zoloft C Klonopin C Effexor C Lactulose C Date:08/28/03ISR Number: 4175073-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174751 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Abilify Tabs 15 Mg PS Otsuka Eyelid Disorder Pharmaceutical Photophobia Company, Ltd. ORAL Zoloft C Amantadine C Ortho Tri-Cyclen C Date:08/28/03ISR Number: 4175074-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12199105 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify Tabs PS Otsuka Anorexia Pharmaceutical Insomnia Company, Ltd. ORAL started 15mg Respiratory Rate samples from Increased 07-Feb-03 to Restlessness 14-Feb-03, Weight Decreased then 3 WK Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL started 15mg samples from 07-Feb-03 to 14-Feb-03, then 3 WK Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL started 15mg samples from 07-Feb-03 to 14-Feb-03, then 3 WK Sinequan C 22-Feb-2006 08:31 AM Page: 152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ambien C Multivitamins C Vitamin B1 C Vitamin B12 C Vitamin C C Seroquel C Date:08/28/03ISR Number: 4175075-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12200994 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify Tabs 15 Mg PS Otsuka Sleep Disorder Pharmaceutical Weight Decreased Company, Ltd. ORAL Started 15mg qd on 16-Jan-03,the n increased to 15mg Topamax C St John Wort C Date:08/28/03ISR Number: 4175076-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12204178 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Abilify Tabs 15 Mg PS Otsuka Other Cardiac Arrest Pharmaceutical Fatigue Company, Ltd. ORAL Started on Myocardial Infarction 5mg/increased to 10mg/increase d to 15mg on 7 WK Haloperidol Decanoate C "On for several years" Artane C "On for several years" Losartan C "On for several years" Propranolol C "on for several years"/In Aug-2002, dosage was Ibuprofen C "On for several years" Fluticasone C Vitamin E C Multivitamin C Hydrochlorothiazide C 22-Feb-2006 08:31 AM Page: 153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175077-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12221057 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 15 Mg PS Otsuka Ejaculation Failure Pharmaceutical Insomnia Company, Ltd. ORAL 5 DAY Male Orgasmic Disorder Risperdal C ORAL at bedtime Nausea Pyrexia Sluggishness Visual Disturbance Date:08/28/03ISR Number: 4175078-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12233235 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify Tabs 15 Mg PS Otsuka Dizziness Pharmaceutical Head Banging Company, Ltd. ORAL 2 DAY Hyperhidrosis Klonopin C Insomnia Restlessness Syncope Visual Disturbance Date:08/28/03ISR Number: 4175079-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12236600 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Agitation Pharmaceutical Breast Pain Company, Ltd. ORAL 06-07-Apr-03, Constipation pt took 15 mg Decreased Appetite 1/4 tab in Dizziness afternoon & Dysgeusia 1/2 tab in Emotional Disorder Haldol C Eye Pain Lorazepam C Facial Pain Tegretol C Fatigue Cogentin C Headache Lamictal C Hunger Buspar C Bristol-Myers Squibb Hyperacusis Company Hypoaesthesia Axert C Liver Disorder Nasopharyngitis Nausea Retching Sinus Headache Somnolence Date:08/28/03ISR Number: 4175080-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246666 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Diabetes Mellitus Pharmaceutical Other Company, Ltd. ORAL 4 DAY 22-Feb-2006 08:31 AM Page: 154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Valproic Acid C Haldol C Date:08/28/03ISR Number: 4175081-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12247292 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hypomania Pharmaceutical Company, Ltd. ORAL took 1-3 tablets 1 DAY Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL took 1-3 tablets 1 DAY Depakote C Neurontin C Navane C ORAL 2 TABLETS at bedtime Inderal C Geodon C Tranxene C Zocor C Dyazide C Synthroid C Allegra C PRN Celebrex C as needed Date:08/28/03ISR Number: 4175082-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12255030 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oral Intake Reduced Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Syncope Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175083-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12257242 Age:5 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Post Procedural Pharmaceutical Complication Company, Ltd. ORAL Syncope Vitamins C Date:08/28/03ISR Number: 4175084-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12257259 Age:8 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Transient Ischaemic Pharmaceutical Attack Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175085-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12259032 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Abilify Tabs 30 Mg PS Otsuka Abnormal Pharmaceutical Company, Ltd. ORAL Ritalin C Dexedrine Spansule C Date:08/28/03ISR Number: 4175086-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12260865 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 5 Mg PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL 10 mg 04-Mar-03 to 15-Apr-03, then 5 mg Klonopin C Neurontin C Lexapro C Wellbutrin C Synthroid C Topamax C Allegra C Date:08/28/03ISR Number: 4175087-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12261574 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Irritability Pharmaceutical Company, Ltd. ORAL Started on 15mg daily/Increas ed to 15mg BID since Lexapro C Lithium C Vasotec C Date:08/28/03ISR Number: 4175088-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12261590 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Wellbutrin C 22-Feb-2006 08:31 AM Page: 156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175089-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12261764 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4175090-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12261954 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4175091-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12262671 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 15mg/increase d to 30mg after the 11th day of Eskalith Cr C Seroquel C Depakote C Date:08/28/03ISR Number: 4175092-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12262952 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Abilify Tabs 15 Mg PS Otsuka Feeling Abnormal Pharmaceutical Flushing Company, Ltd. ORAL Joint Swelling Clorazepate C Myalgia Remeron C Pain In Extremity Duragesic Patch C Pallor Vision Blurred Date:08/28/03ISR Number: 4175093-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12263208 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 5mg daily/increas ed to 10mg daily on 22-Feb-2006 08:31 AM Page: 157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175094-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12263398 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Abilify Tabs 15 Mg PS Otsuka Other Tremor Pharmaceutical Company, Ltd. ORAL Only 2 doses were taken Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Only 2 doses were taken Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Only 2 doses were taken Effexor Xr C 3 WK Date:08/28/03ISR Number: 4175095-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12265393 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify PS Otsuka Dyskinesia Pharmaceutical Company, Ltd. ORAL Topamax C Taken at hour of sleep Klonopin C Effexor Xr C Lithium C Date:08/28/03ISR Number: 4175096-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12266391 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cough Abilify Tabs 15 Mg PS Otsuka Dyspnoea Pharmaceutical Company, Ltd. ORAL Started on 7.5mg daily for 4 days one month ago/increased Lamictal C Klonopin C Inhalers C Date:08/28/03ISR Number: 4175097-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12267647 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Abilify Tabs 15 Mg PS Otsuka Eye Rolling Pharmaceutical Nuchal Rigidity Company, Ltd. ORAL interrupted Photophobia on 06-May-2003 Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL interrupted on 22-Feb-2006 08:31 AM Page: 158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 06-May-2003 Gabapentin C Zyprexa C Multivitamin C Date:08/28/03ISR Number: 4175098-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12269544 Age:9 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs 5 Mg PS Otsuka Hunger Pharmaceutical Insomnia Company, Ltd. ORAL Started on Liver Function Test 5mg Abnormal daily/Increas Swelling Face ed to 5mg BID Thyroid Function Test on Abnormal Depakote C Weight Increased Date:08/28/03ISR Number: 4175099-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12270310 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs PS Otsuka Hypersomnia Pharmaceutical Increased Appetite Company, Ltd. ORAL started 7.5 mg daily hs, dose increased to 15 mg hs, 3 WK Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL started 7.5 mg daily hs, dose increased to 15 mg hs, 3 WK Strattera C Lexapro C Seroquel C Date:08/28/03ISR Number: 4175100-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12270369 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started 15 mg daily, then dose decreased to 7.5 mg daily 22-Feb-2006 08:31 AM Page: 159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175101-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12270757 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify Tabs 30 Mg PS Otsuka Mania Pharmaceutical Company, Ltd. ORAL Zyprexa C last dose in beginning of April Effexor C Trileptal C Singulair C Klonopin C Ativan C Benadryl C Date:08/28/03ISR Number: 4175102-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12270781 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Abilify Tabs PS Otsuka Rash Pharmaceutical Sedation Company, Ltd. ORAL Began on about 3/28/03 10 mg in a.m.& 15mg in p.m.;dose Date:08/28/03ISR Number: 4175103-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12270815 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hunger Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175104-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12270880 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL On 20mg daily for approximately 2 months. 2 MON Date:08/28/03ISR Number: 4175105-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12273025 Age:35 YR Gender:Male I/FU:I Outcome PT Anorexia Fatigue Insomnia Nausea Palpitations Restlessness 22-Feb-2006 08:31 AM Page: 160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sluggishness Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started 10 mg daily 2 weeks ago, dose increased to 20 mg daily 2 WK Date:08/28/03ISR Number: 4175106-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12273264 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify was stopped, but MD hoped to restart Abilify after Date:08/28/03ISR Number: 4175107-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12273371 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175108-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12273769 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL Started on 5mg/Increased to 10mg on 22-Apr-2003 Lorazepam C ORAL Had taken for "many" years/started a slow taper 1 week prior Gabitril C ORAL 8 MON Lexapro C ORAL 6 WK Zyprexa I ORAL Dose was increased to 15mg from 10mg in the past month 1 YR 22-Feb-2006 08:31 AM Page: 161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175109-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12273850 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Cozaar C Bristol-Myers Squibb Company Cardura C Spironolactone C Lasix C Prednisone C Risperidal C Date:08/28/03ISR Number: 4175110-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274148 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 WK Date:08/28/03ISR Number: 4175111-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274205 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Propecia C Klonopin C Date:08/28/03ISR Number: 4175112-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274213 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Hyperhidrosis Pharmaceutical Hypoaesthesia Oral Company, Ltd. ORAL consumer took Mania 5 mg (1/2 of Somnolence a 10 mg Vision Blurred tablet) twice daily Lamictal C Trileptal C Zoloft C Premarin C Lipitor C Clonazepam C Cipro C Cipro was changed to cephalexin Cephalexin C Apothecon 22-Feb-2006 08:31 AM Page: 162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175113-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274254 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Zyprexa C Ativan C Paxil Cr C Glucophage C Bristol-Myers Squibb Company Lipitor C Atenolol C Geneva Pharmaceuticals Technology, Corp. Protonix C Risperidone C Metamucil C Trazodone Hcl C Apothecon Wellbutrin C Cogentin C Date:08/28/03ISR Number: 4175114-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274379 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Prozac C Date:08/28/03ISR Number: 4175116-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274700 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify Tabs 15 Mg PS Otsuka Anorexia Pharmaceutical Nausea Company, Ltd. ORAL started 15 mg daily, reduced dose of Abilify to 10 mg daily 1 MON Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL started 15 mg daily, reduced dose of Abilify to 10 mg daily 1 MON Tegretol C Date:08/28/03ISR Number: 4175117-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12274882 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs 30 Mg PS Otsuka Sexual Dysfunction Pharmaceutical 22-Feb-2006 08:31 AM Page: 163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Patient on Abilify since Dec-02, on Abilify 30 mg daily since Paxil C Lorazepam C Vasotec C Zocor C Androgel C Protonix C Flomax C Date:08/28/03ISR Number: 4175118-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12275095 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL On Abilify for the past month. 1 MON Date:08/28/03ISR Number: 4175119-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12275434 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Abilify PS Otsuka Pharmaceutical Company, Ltd. Patient was taking medication for 8 days/No other info Inderal C Date:08/28/03ISR Number: 4175120-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12275483 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Neurontin C One-A-Day C Potassium C Magnesium C Date:08/28/03ISR Number: 4175121-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12275558 Age:38 YR Gender:Female I/FU:I Outcome PT Anxiety Asthenia Diarrhoea Dizziness Headache Nausea 22-Feb-2006 08:31 AM Page: 164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Vision Blurred Vomiting Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Expiration date: 01-May-2004 Synthroid C Trileptal C Gabitril C Maxzide C Prevacid C Zantac C Date:08/28/03ISR Number: 4175122-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12275665 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175123-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12276044 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify Tabs PS Otsuka Anxiety Pharmaceutical Company, Ltd. ORAL On Abilify about 3 weeks ago for 2 weeks; re-started on Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL On Abilify about 3 weeks ago for 2 weeks; re-started on Tylenol Extra Strength C Tylenol + Codeine C Lopressor C Protonix C Colace C Zoloft C Date:08/28/03ISR Number: 4175124-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12277158 Age:11 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. No information reported 22-Feb-2006 08:31 AM Page: 165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175125-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12277562 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Weight Decreased Company, Ltd. ORAL 3 WK Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK Mellaril C Ativan C Depakote C Date:08/28/03ISR Number: 4175126-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12277638 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs PS Otsuka Asthenia Pharmaceutical Constipation Company, Ltd. ORAL Faecaloma Insomnia Nausea Date:08/28/03ISR Number: 4175127-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12278032 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Glucophage C Bristol-Myers Squibb Company Date:08/28/03ISR Number: 4175128-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12278677 Age:23 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Hesitation Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C Clonapin C Date:08/28/03ISR Number: 4175129-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279394 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started 10 mg daily on 21-Apr-03, dose reduced to 7.5 mg hs Abilify Tabs 10 Mg SS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL started 10 mg daily on 21-Apr-03, dose reduced to 7.5 mg hs Risperdal C risperdal weaned off 2 weeks after starting Abilify. Cogentin C Cogentin weaned off from 21-Apr-03 to 07-May-03. Date:08/28/03ISR Number: 4175130-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279410 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify Tabs 15 Mg PS Otsuka Phosphokinase Increased Pharmaceutical Company, Ltd. ORAL Zoloft C Date:08/28/03ISR Number: 4175131-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279758 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Olanzapine C Lithium C Date:08/28/03ISR Number: 4175132-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279824 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Antipsychotic C Date:08/28/03ISR Number: 4175133-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279840 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Drug Tolerance Decreased Pharmaceutical Insomnia Company, Ltd. ORAL Possibly on 15-30mg/day 22-Feb-2006 08:31 AM Page: 167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175134-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279881 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Haldol Decanoate C Date:08/28/03ISR Number: 4175135-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279923 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175136-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12279956 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Akathisia Pharmaceutical Company, Ltd. ORAL Seroquel C Epivir C "Epivir/3TC" Kaletra C Nevirapine C Tenofovir C Mycelex Troche C Wellbutrin Sr C Date:08/28/03ISR Number: 4175137-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280046 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient's were on 10 or 15 mg Abilify Date:08/28/03ISR Number: 4175138-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280079 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 MON Depakote C Date:08/28/03ISR Number: 4175139-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280103 Age:29 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Akathisia 22-Feb-2006 08:31 AM Page: 168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Olanzapine C Date:08/28/03ISR Number: 4175140-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280129 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175141-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280137 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175142-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280467 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175143-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280483 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175144-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280525 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Prolixin C Apothecon Date:08/28/03ISR Number: 4175145-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280574 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Mania Pharmaceutical 22-Feb-2006 08:31 AM Page: 169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Date:08/28/03ISR Number: 4175146-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280608 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify Tabs PS Otsuka Dystonia Pharmaceutical Company, Ltd. ORAL Exact dates not reported Date:08/28/03ISR Number: 4175147-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280616 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs PS Otsuka Dizziness Pharmaceutical Fall Company, Ltd. ORAL 15mg daily 2nd wk of March;increas ed to 30mg after 2 Geodon C Celexa C Seroquel C Date:08/28/03ISR Number: 4175148-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12280830 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175149-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281069 Age:7 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175150-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281077 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175151-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281143 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical 22-Feb-2006 08:31 AM Page: 170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 1 MON Zyprexa C Gradually started reducing olanzapine on 10-Apr-2003, Depakote C Date:08/28/03ISR Number: 4175152-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281192 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Olanzapine C Risperidone C Date:08/28/03ISR Number: 4175153-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281838 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Abilify Tabs 30 Mg PS Otsuka Pain Pharmaceutical Psychomotor Hyperactivity Company, Ltd. ORAL Started 15 mg daily at end of Apr-03,then increased to Topamax C "on for at least a few months" Seroquel C "on for a few months" Date:08/28/03ISR Number: 4175154-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282034 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Orthostatic Hypotension Pharmaceutical Somnolence Company, Ltd. ORAL Dosage reduced to 7.5 mg daily/increas ed to Date:08/28/03ISR Number: 4175155-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282075 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify Tabs 10 Mg PS Otsuka Fatigue Pharmaceutical Feeling Hot Company, Ltd. ORAL Started drug Hyperhidrosis "about a week Muscle Spasms ago" Abilify Tabs 10 Mg SS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Started drug "about a week ago" Desyrel C Apothecon Clonidine C Ritalin C Vistaril C Topamax C Date:08/28/03ISR Number: 4175156-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282083 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Abilify Tabs PS Otsuka Increased Pharmaceutical Blood Urea Increased Company, Ltd. ORAL Urinary Retention Fosamax C Synthroid C Lasix C Insulin C Cogentin C Neurontin C Geodon C Felodipine C Trazodone Hcl Tabs C Apothecon Macrobid C Date:08/28/03ISR Number: 4175157-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282091 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Started on 15 mg/Increased to 30mg on 8-Apr-2003. Metoprolol C Amlodipine C Date:08/28/03ISR Number: 4175158-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282141 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 1 MON Date:08/28/03ISR Number: 4175159-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282299 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Abilify Tabs PS Otsuka Rash Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175160-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282448 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:08/28/03ISR Number: 4175161-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282455 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL Clozaril C Date:08/28/03ISR Number: 4175162-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282471 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175163-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282489 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Consciousness Pharmaceutical Disorientation Company, Ltd. ORAL Muscle Rigidity Nausea Pyrexia Urinary Incontinence Vomiting Date:08/28/03ISR Number: 4175164-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282679 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify Tabs PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Patient started 15 mg daily and increased in 7 days to 30 Lithium C Depakote C 22-Feb-2006 08:31 AM Page: 173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175165-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12282992 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify Tabs PS Otsuka Oedema Pharmaceutical Rash Company, Ltd. Date:08/28/03ISR Number: 4175166-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12283115 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akinesia Abilify Tabs PS Otsuka Difficulty In Walking Pharmaceutical Drug Interaction Company, Ltd. ORAL Started 10 mg Memory Impairment daily and Musculoskeletal Stiffness increased to Parkinsonism 30 mg Tremor daily,then Lamictal C Effexor C Lithium I Date:08/28/03ISR Number: 4175167-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12283511 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4175168-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12283719 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Psychomotor Hyperactivity Pharmaceutical Company, Ltd. No information reported Date:08/28/03ISR Number: 4175169-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12283875 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL therapy started 5 or 6 days ago Avapro C Bristol-Myers Squibb Company Ativan C Prozac C Ecotrin C Androgel C TOPICAL Multivitamin C Tums C "at times" 22-Feb-2006 08:31 AM Page: 174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175170-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12285367 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175171-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12285375 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs PS Otsuka Feeling Hot Pharmaceutical Company, Ltd. ORAL Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Wellbutrin C Sonata C Xanax C Pravachol Tabs C Bristol-Myers Squibb Company Date:08/28/03ISR Number: 4175172-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12285813 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify Tabs 15 Mg PS Otsuka Drug Level Increased Pharmaceutical Drug Toxicity Company, Ltd. ORAL Gait Disturbance Multivitamins C Nausea Depakote I Tremor Vomiting Date:08/28/03ISR Number: 4175173-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12286209 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK Lithium C Depakote C Date:08/28/03ISR Number: 4175174-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12286381 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL at night 1 WK Topamax C Advair C Contraceptive C Omega-3 C Vitamin B Complex C 22-Feb-2006 08:31 AM Page: 175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin E C Multivitamin C Date:08/28/03ISR Number: 4175175-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12286795 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Acneiform Abilify Tabs PS Otsuka Headache Pharmaceutical Priapism Company, Ltd. ORAL Started 15 mg Tongue Oedema daily, then increased to 30 mg daily 2 weeks later, Haldol C Pt weaned off of Haldol, off for 1 month, then restarted Depakote C Artane C Cogentin C Date:08/28/03ISR Number: 4175176-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12286910 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Abilify Tabs 15 Mg PS Otsuka Tachycardia Pharmaceutical Company, Ltd. ORAL Taken "for the last month". Med was stopped for 2 Synthroid C Taken for "years" Aspirin Buffered C "One tablet for several years" YR Effexor Xr C ORAL Gabitril C Taken at hour of sleep Date:08/28/03ISR Number: 4175177-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12287363 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Abilify Tabs 15 Mg PS Otsuka Oedema Peripheral Pharmaceutical Urine Abnormality Company, Ltd. ORAL 1 DAY Topamax C Ativan C Vicodin C 22-Feb-2006 08:31 AM Page: 176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175178-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12288080 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Swelling Abilify Tabs 10 Mg PS Otsuka Oedema Peripheral Pharmaceutical Vision Blurred Company, Ltd. ORAL 1 tablet daily in the evening Date:08/28/03ISR Number: 4175179-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12288213 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Started 5mg (1/2 of 10mg tab) qd for 3 days,then 10mg qd,then Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Started 5mg (1/2 of 10mg tab) qd for 3 days,then 10mg qd,then Lithium C Date:08/28/03ISR Number: 4175180-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12288643 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Started 7.5mg daily on 5/14/03; dose increased to 15mg daily on Lithium C Date:08/28/03ISR Number: 4175181-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12288692 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Abilify Tabs 15 Mg PS Otsuka Depression Pharmaceutical Formication Company, Ltd. ORAL Nervousness Lithium C Panic Attack Benztropine Mesylate C Self Esteem Decreased Synthroid C Tremor Ferrous Sulfate C Folic Acid C 22-Feb-2006 08:31 AM Page: 177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175182-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12288866 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175183-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12288874 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 DAY Date:08/28/03ISR Number: 4175184-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12289070 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175185-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12289526 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Zyprexa C Cardizem C Date:08/28/03ISR Number: 4175186-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12289898 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Geodon SS Date:08/28/03ISR Number: 4175187-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12290011 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apathy Abilify Tabs 15 Mg PS Otsuka Asthenia Pharmaceutical Dizziness Company, Ltd. ORAL 10 DAY Somnolence Xanax C 22-Feb-2006 08:31 AM Page: 178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175188-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12290102 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started on lower dose and increased to 30 mg daily (on for Zoloft C Vioxx C Prandin C Prevacid C Avandia C Lipitor C Monopril Tabs C Bristol-Myers Squibb Company Reglan C Glucovance Tabs C Bristol-Myers Squibb Company Multivitamin C Date:08/28/03ISR Number: 4175189-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12290771 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Wellbutrin C Date:08/28/03ISR Number: 4175190-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12290789 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polymenorrhoea Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Date:08/28/03ISR Number: 4175191-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291183 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175192-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291316 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Drug Interaction Pharmaceutical Hallucination Company, Ltd. Seroquel I 22-Feb-2006 08:31 AM Page: 179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175193-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291456 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Abilify Tabs 10 Mg PS Otsuka Headache Pharmaceutical Company, Ltd. ORAL Increased to 20mg at end of Mar-03/Increa sed to Tegretol C Increased to 800MG On 04-MAR-03/Inc reased to 1000mg on Lamictal C Increased to 400 mg daily on 02-Jun-2003. Date:08/28/03ISR Number: 4175194-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291886 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Abilify Tabs 15 Mg PS Otsuka Hyperhidrosis Pharmaceutical Pancreatitis Company, Ltd. 1 MON Wellbutrin C Taking for the past 3-4 years Celexa C Taking for past 1-2 years Date:08/28/03ISR Number: 4175195-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291936 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Geodon SS Date:08/28/03ISR Number: 4175196-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12292223 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 10 Mg PS Otsuka Nausea Pharmaceutical Somnolence Company, Ltd. ORAL took 10 mg daily on 12-May-2003 and on 16-May-2003. Tegretol C Effexor C Lexapro C Strattera C 22-Feb-2006 08:31 AM Page: 180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel C Lorazepam C Ativan C Levoxyl C Provigil C Date:08/28/03ISR Number: 4175197-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12292645 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 10 Mg PS Otsuka Visual Disturbance Pharmaceutical Company, Ltd. ORAL Lithium C Glucotrol C Zyprexa C Date:08/28/03ISR Number: 4175198-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12292652 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Date:08/28/03ISR Number: 4175199-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12292934 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175200-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12292967 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 1 MON Zyprexa C Date:08/28/03ISR Number: 4175201-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12294401 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175202-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12295184 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL Event Aminotransferase occurred Increased after two doses of medication. Date:08/28/03ISR Number: 4175203-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12295689 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify Tabs 10 Mg PS Otsuka Blood Pressure Decreased Pharmaceutical Chest Pain Company, Ltd. ORAL Patient took Dizziness two doses Nausea Lexapro C 1 YR Tremor Benadryl C 1 YR Cogentin C 1 YR Seroquel C 1 YR Trileptal C 1 YR Topamax C 1 YR Hydrocodone C Taken for neck pain 1 MON Date:08/28/03ISR Number: 4175204-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12295747 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysuria Abilify Tabs 15 Mg PS Otsuka Micturition Urgency Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C Date:08/28/03ISR Number: 4175205-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12295986 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Neurontin C Zoloft C Contraceptive C ORAL Date:08/28/03ISR Number: 4175206-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12296620 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Extrapyramidal Disorder Pharmaceutical 22-Feb-2006 08:31 AM Page: 182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Date:08/28/03ISR Number: 4175207-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12296885 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175208-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12296893 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraphilia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175209-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12296950 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Started 15 mg daily, then dose increased to 30 mg daily. Zyprexa C Klonopin C Depakote C Amantadine C Hydrochlorothiazide C Prevacid C Tapazole C Date:08/28/03ISR Number: 4175210-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12297040 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Effexor C Date:08/28/03ISR Number: 4175211-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12297503 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Abilify Tabs 15 Mg PS Otsuka Throat Tightness Pharmaceutical Company, Ltd. ORAL Mellaril C Depakote C 22-Feb-2006 08:31 AM Page: 183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175212-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12297560 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175213-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12297867 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22.5-15mg, once a day since 11-Mar-2003. Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 22.5-15mg, once a day since 11-Mar-2003. Lithium C Neurontin C Concerta C Ritalin C Alupent C Date:08/28/03ISR Number: 4175214-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12297917 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Abilify Tabs PS Otsuka Delusion Pharmaceutical Company, Ltd. ORAL Started 15 mg, then increased to 30 mg 4 WK Date:08/28/03ISR Number: 4175215-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12298006 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs PS Otsuka Muscle Rigidity Pharmaceutical Company, Ltd. ORAL Started on 15 mg, then increased to 20 mg Date:08/28/03ISR Number: 4175216-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12298816 Age:53 YR Gender:Female I/FU:I Outcome PT Dyskinesia Muscle Twitching 22-Feb-2006 08:31 AM Page: 184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Tremor Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 dose 26-May-03 and 27-May-03,sto pped for 4 days,re-start Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 dose 26-May-03 and 27-May-03,sto pped for 4 days,re-start Lithobid C Topamax C Luvox C Clonidine C Klonopin C Risperdal C Date:08/28/03ISR Number: 4175217-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12298824 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 20 Mg PS Otsuka Akathisia Pharmaceutical Company, Ltd. ORAL Started 10mg qd 6 weeks ago; increased to 20mg qd 3-4 Cogentin C Klonopin C Prozac C Date:08/28/03ISR Number: 4175218-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12299152 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 15 Mg PS Otsuka Musculoskeletal Stiffness Pharmaceutical Company, Ltd. ORAL 2 WK Zoloft C Date:08/28/03ISR Number: 4175219-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12299160 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Abilify Tabs PS Otsuka Decreased Pharmaceutical Company, Ltd. ORAL Tegretol SS 22-Feb-2006 08:31 AM Page: 185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175220-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12299392 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Taking 10mg "sporadically " since Jan-2003. Allegra C Zyprexa C Triamcinolone C Apothecon Hydrocortisone C Tridesilon C Date:08/28/03ISR Number: 4175221-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12300117 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Nervousness Pharmaceutical Restlessness Company, Ltd. ORAL Started "about 1 week ago" at bedtime 1 WK Ativan C Neurontin C Seroquel C Date:08/28/03ISR Number: 4175222-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12300141 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify Tabs PS Otsuka Difficulty In Walking Pharmaceutical Dyskinesia Company, Ltd. ORAL Started 15mg Dyspnoea qd on Eye Swelling 29-Apr-03,the Fatigue n increased 2 Feeling Abnormal wks later to Hypokinesia Abilify Tabs SS Otsuka Irritability Pharmaceutical Sedation Company, Ltd. ORAL Started 15mg Speech Disorder qd on Staring 29-Apr-03,the n increased 2 wks later to Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Started 15mg qd on 29-Apr-03,the n increased 2 wks later to Zyrtec C Prilosec C Risperdal C Lexapro C 22-Feb-2006 08:31 AM Page: 186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175223-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12300265 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Taking for "over 1 month". Date:08/28/03ISR Number: 4175224-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12300679 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL 10mg tablet- 1/2 tab daily 3 WK Date:08/28/03ISR Number: 4175225-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12301248 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175226-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12301297 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175227-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12301370 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175228-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12302873 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs 15 Mg PS Otsuka Dyspepsia Pharmaceutical Company, Ltd. ORAL Stelazine C Cogentin C Zyprexa C 22-Feb-2006 08:31 AM Page: 187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175229-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12303186 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL Patient was on drug for 3-4 weeks prior to the event Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Patient was on drug for 3-4 weeks prior to the event Metoprolol C Dyazide C Lipitor C Taken at bedtime Vasotec C Aspirin C Niaspan C Taken at bedtime Darvocet-N 100 C Taken every 6 hours as needed Date:08/28/03ISR Number: 4175230-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12303301 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affective Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 7.5mg qd; increased to 15mg. Date:08/28/03ISR Number: 4175231-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12303343 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration General Physical Health Abilify Tabs 20 Mg PS Otsuka Deterioration Pharmaceutical Irritability Company, Ltd. ORAL Started 2 Thought Blocking weeks ago around 04-Jun-2003 2 WK Trileptal SS Reporter think she was on 300mg twice daily Topamax C Depakote C 500MG IN THE MORNING & 652MG IN THE EVENING. 22-Feb-2006 08:31 AM Page: 188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175232-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12303368 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175233-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12303848 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Abilify Tabs 15 Mg PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL Patient takes Aminotransferase 1/2 of a 15 Increased mg tablet Depakote C Zyprexa C Date:08/28/03ISR Number: 4175234-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12303947 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Aminotransferase Pharmaceutical Other Increased Company, Ltd. ORAL Bradycardia Depressed Level Of Consciousness Electrocardiogram Qt Prolonged Feeling Abnormal Hypokalaemia Hypotension Mydriasis Overdose Suicide Attempt Date:08/28/03ISR Number: 4175235-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12304416 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 15 Mg PS Otsuka Blood Prolactin Increased Pharmaceutical Insomnia Company, Ltd. ORAL Menstrual Disorder Risperdal C Synthroid C Colace C Ativan C Tylenol Pm C Clarinex C "Clarinet" 22-Feb-2006 08:31 AM Page: 189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175236-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12304606 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Postmenopausal Abilify Tabs 30 Mg PS Otsuka Haemorrhage Pharmaceutical Company, Ltd. ORAL started 15mg in 11/02 & presently takes 30mg daily Hormone Therapy C 15 YR Date:08/28/03ISR Number: 4175237-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12304655 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Impaired Healing Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL initial dose of 15 mg daily, increased to 20 mg daily Seroquel C Lithobid C Ativan C Zoloft C Date:08/28/03ISR Number: 4175238-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12304820 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Neutrophil Count Abnormal Pharmaceutical White Blood Cell Count Company, Ltd. ORAL Decreased Clozapine C Had 2 trials; current Rx has been continous since 7/00; Valproic Acid C Atenolol C Geneva Pharmaceuticals Technology, Corp. Date:08/28/03ISR Number: 4175239-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12305215 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Toothache Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL On Abilify since 10 days ago. 10 DAY 22-Feb-2006 08:31 AM Page: 190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175240-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12305298 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175241-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12305314 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4175242-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12306379 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lip Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL One tablet (15mg) daily 3 WK Paxil C Date:08/28/03ISR Number: 4175243-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12306668 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pulmonary Embolism Pharmaceutical Company, Ltd. ORAL Haloperidol C Taken for "years" Depakote C Taken in the AM. Taken for "years" Depakote C Taken at hour of sleep (HS). Taken for "years" Neurontin C Taken for "years" Lorazepam C Taken for "5 to 6 years" Lexapro C Taken for 5 months Flomax C Colace C Date:08/28/03ISR Number: 4175244-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12306692 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs PS Otsuka Confusional State Pharmaceutical Serotonin Syndrome Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175245-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12306817 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. No information reported Date:08/28/03ISR Number: 4175246-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12306874 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Lithium C Adderall C Date:08/28/03ISR Number: 4175248-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12306940 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Date:08/28/03ISR Number: 4175249-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12307179 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotonia Abilify PS Otsuka Pharmaceutical Company, Ltd. No information was reported Date:08/28/03ISR Number: 4175250-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12307393 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs 15 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL started in mid Feb 2003; switched to 7.5 mg mid April 2003 Wellbutrin Sr C Trileptal C Seroquel C Catapres C patch Tramadol C 22-Feb-2006 08:31 AM Page: 192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175251-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12307435 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL On for "2 or 3 months". Date:08/28/03ISR Number: 4175252-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12307625 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotonia Abilify PS Otsuka Pharmaceutical Company, Ltd. No information was reported Date:08/28/03ISR Number: 4175253-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12307674 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotonia Abilify PS Otsuka Pharmaceutical Company, Ltd. No information reported Date:08/28/03ISR Number: 4175254-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12308193 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175255-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12308631 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Lorazepam C Nexium C Zovirax C Klonopin C Trazodone Hcl Tabs C Apothecon Effexor C Rhinocort C Doxycycline C Doxycycline "just discontinued after a 6 22-Feb-2006 08:31 AM Page: 193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report week cycle" Date:08/28/03ISR Number: 4175256-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12308714 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 5-Htp C Lamictal C Date:08/28/03ISR Number: 4175257-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12308730 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4175258-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12308839 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgeusia Abilify Tabs PS Otsuka Glossodynia Pharmaceutical Company, Ltd. ORAL 3 DAY Lamictal C Klonopin C twice a day as needed Gabitril C Date:08/28/03ISR Number: 4175259-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12309399 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs PS Otsuka Hallucination, Visual Pharmaceutical Company, Ltd. ORAL increased to 30 mg once daily 2 weeks ago Lexapro C Risperdal C Date:08/28/03ISR Number: 4175260-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12309456 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175261-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12309886 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL started therapy "3 and 1/2 weeks ago" Lithium C Imipramine C Ambien C Multivitamin C Calcium C Iron C Date:08/28/03ISR Number: 4175262-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12310272 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Encopresis Abilify Tabs PS Otsuka Eye Movement Disorder Pharmaceutical Company, Ltd. ORAL Took one dose of 7.5mg Seroquel C Adderall C Date:08/28/03ISR Number: 4175263-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12310298 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5mg once a day for 3 days. 3 DAY Depakote C Topamax C Date:08/28/03ISR Number: 4175264-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12310322 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 DAY Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 DAY Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 DAY Zoloft C Seroquel C After the AEs, restarted on 25mg once a day. 22-Feb-2006 08:31 AM Page: 195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175265-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311023 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175266-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311072 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Dehydration Pharmaceutical Other Neuroleptic Malignant Company, Ltd. ORAL 15 mg/day Syndrome from Paranoia 29-Apr-2003 Suicidal Ideation until Urinary Tract Infection 11-Jun-2003, Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day from 29-Apr-2003 until 11-Jun-2003, Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day from 29-Apr-2003 until 11-Jun-2003, Prozac C Xanax C Benadryl C Risperdal C 29-Apr-2003 = .5 mg; discontinued on 21-May-2003; Date:08/28/03ISR Number: 4175267-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311080 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Remeron C Paxil C Neurontin C Wellbutrin C Zestril C 22-Feb-2006 08:31 AM Page: 196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175268-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311239 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Suicidal Ideation Pharmaceutical Other Company, Ltd. ORAL 1 MIN Neurontin C 3 YR Synthroid C Zyprexa C 3 YR Lorazepam C 4 YR Avandia C Vasotec C Lipitor C 3 YR Niacin C 2 YR Aspirin C 2 YR Benztropine C Date:08/28/03ISR Number: 4175269-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311254 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Fear Pharmaceutical Feeling Abnormal Company, Ltd. ORAL Psychotic Disorder Lithium C Date:08/28/03ISR Number: 4175270-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311270 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Formication Abilify Tabs 15 Mg PS Otsuka Psychotic Disorder Pharmaceutical Social Avoidant Behaviour Company, Ltd. ORAL Abilify dose was held on 26-Jun-2003 Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify dose was held on 26-Jun-2003 Depakote C Zyprexa C Trazodone Hcl C Apothecon Date:08/28/03ISR Number: 4175271-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311569 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175272-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311833 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Abilify Tabs 20 Mg PS Otsuka Lymphadenopathy Pharmaceutical Pyrexia Company, Ltd. ORAL Started on 5mg 04-24/dosage was increased/dru Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 5mg 04-24/dosage was increased/dru Lamictal C Started on 25mg on 08-May/Increa sed to 50mg on Lithium C 300 mg qam/600 mg qhs Date:08/28/03ISR Number: 4175273-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311981 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. no information reported Date:08/28/03ISR Number: 4175274-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12313037 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175275-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12313185 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Seroquel C Kemadrin C 22-Feb-2006 08:31 AM Page: 198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175276-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315800 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175277-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315925 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4175278-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315958 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4175279-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315966 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Irritability Pharmaceutical Restlessness Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Tofranil C Xanax C Date:08/28/03ISR Number: 4175280-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315990 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify Tabs 15 Mg PS Otsuka Gait Disturbance Pharmaceutical Parkinsonism Company, Ltd. ORAL Psychomotor Retardation Date:08/28/03ISR Number: 4175281-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12316758 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175282-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12316832 Age:5 DEC Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Erythematous Abilify Tabs 15 Mg PS Otsuka Urticaria Pharmaceutical Company, Ltd. ORAL On therapy for a "few days" Klonopin C Serzone Tabs C Bristol-Myers Squibb Company Date:08/28/03ISR Number: 4176136-XReport Type:Direct Company Report #CTU 200870 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify 15 Mg Bristol Squibb PS Bristol Squibb ORAL 40 MG DAY ORAL Abilify 10 Mg Bristol Squibb SS Bristol Squibb Aspirin C Lipitor C Lithium C Glucophage Xr C Date:08/28/03ISR Number: 4176593-9Report Type:Direct Company Report #CTU 200865 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Abilify 10 Mg Extrapyramidal Disorder Bristol PS Bristol ORAL 10 MG AT Parkinson'S Disease BEDTIM ORAL Date:08/28/03ISR Number: 4187678-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12316865 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify Tabs 20 Mg PS Otsuka Eye Rolling Pharmaceutical Company, Ltd. ORAL Taking 1 tablet twice daily for "a while". Flovent C RESPIRATORY (INHALATION) Albuterol C RESPIRATORY (INHALATION) Alavert I Date:08/28/03ISR Number: 4187679-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12316980 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Abilify Tabs 10 Mg PS Otsuka Pruritus Pharmaceutical Company, Ltd. ORAL Dose: 1/2 of 22-Feb-2006 08:31 AM Page: 200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report a 10mg tablet, at bedtime for 1 week, then Paxil C Trileptal C Xopenex C Pulmicort C Date:08/28/03ISR Number: 4187680-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12317038 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Jittery Abilify Tabs 15 Mg PS Otsuka Nervousness Pharmaceutical Somnolence Company, Ltd. ORAL Benadryl C Singulair C Advair C Date:08/28/03ISR Number: 4187681-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12317087 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify Tabs PS Otsuka Medication Error Pharmaceutical Palpitations Company, Ltd. ORAL As of 12/02, took "prescribed" dose of 15mg qd. 3 WK Clonidine C 2 YR Date:08/28/03ISR Number: 4187682-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12317517 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Began taking 10mg qd at night on 01 or 02-May-2003;i Prozac SS Buspar Tabs 30 Mg C ORAL Benztropine C Haloperidol C Lorazepam C Fluoxetine C Mirtazapine C Methylphenidate C Thyroid C Trazodone Hcl C Apothecon Bupropion C 22-Feb-2006 08:31 AM Page: 201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187683-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12317749 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187684-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12321139 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Blood Sodium Decreased Pharmaceutical Contusion Company, Ltd. "12 or 15 mg Fall daily" Mental Status Changes Hydrochlorothiazide SS Oedema Peripheral Baby Aspirin C Celexa C Diovan C Metformin Hcl C Bristol-Myers Squibb Company Isordil C Minoxidil C Discontinued after 1 or 2 doses. Nitroglycerin Patch C Protonix C Vioxx C Lantus C Albuterol Inhaler C Clonidine C Diltiazem Hcl C Apothecon Date:08/28/03ISR Number: 4187685-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12321311 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Alanine Aminotransferase Pharmaceutical Increased Company, Ltd. ORAL discontinued Aspartate on either Aminotransferase 26-Jun-2003 Increased or Constipation 27-Jun-2003 Nausea Celexa C 1 YR Vomiting Seroquel C Ambien C Synthroid C Albuterol Inhaler C Ranitidine C Reglan C Ativan C 22-Feb-2006 08:31 AM Page: 202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187686-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12321840 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retching Abilify Tabs PS Otsuka Vomiting Pharmaceutical Weight Decreased Company, Ltd. ORAL at bedtime,start ed therapy "approximatel y 3 weeks Date:08/28/03ISR Number: 4187687-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12321857 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Abilify Tabs PS Otsuka Initial or Prolonged Muscle Rigidity Pharmaceutical Psychomotor Hyperactivity Company, Ltd. ORAL Started Regressive Behaviour therapy 4 Social Avoidant Behaviour weeks ago (10 Speech Disorder or 15 mg daily) Ativan C 0.5 MG/THREE TIMES A DAY AND 1.0 MG AT BEDTIME Toprol Xl C Date:08/28/03ISR Number: 4187688-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12322251 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Suicide Attempt Pharmaceutical Other Company, Ltd. Lexapro SS Date:08/28/03ISR Number: 4187689-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12322673 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187690-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12322764 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started taking 10 mg one tablet daily in March 2003, Diphenhydramine C 22-Feb-2006 08:31 AM Page: 203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Docusate C Senna C Date:08/28/03ISR Number: 4187691-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12322830 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs PS Otsuka Body Temperature Pharmaceutical Increased Company, Ltd. ORAL started on 15 mg daily and after 3 days was increased to 30 mg once Risperdal C Lithium C Date:08/28/03ISR Number: 4187692-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12322848 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Adderall Xr C Lexapro C Neurontin C Date:08/28/03ISR Number: 4187693-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12322863 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Date:08/28/03ISR Number: 4187694-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12323556 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187695-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12324117 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187696-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12324133 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187697-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12324422 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Date:08/28/03ISR Number: 4187699-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12325486 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urticaria Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Zyprexa C Klonopin C Serzone Tabs C Bristol-Myers Squibb Company Date:08/28/03ISR Number: 4187700-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12325890 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Physician wants consumer to restart Abilify at 10 Date:08/28/03ISR Number: 4187701-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12325981 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify Tabs 15 Mg PS Otsuka Pre-Existing Condition Pharmaceutical Improved Company, Ltd. ORAL 15 mg once Therapeutic Response daily in the Unexpected evening Weight Decreased Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg once daily in the evening 22-Feb-2006 08:31 AM Page: 205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topamax C Ibuprofen C Date:08/28/03ISR Number: 4187702-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12326021 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Akinesia Pharmaceutical Extrapyramidal Disorder Company, Ltd. ORAL Zyprexa C initial dose of 15 mg Provigil C Lexapro C Date:08/28/03ISR Number: 4187703-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12326039 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akinesia Abilify Tabs PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Wellbutrin C Lithium C Date:08/28/03ISR Number: 4187704-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12326088 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depersonalisation Abilify Tabs PS Otsuka Insomnia Pharmaceutical Nausea Company, Ltd. ORAL 5mg- 1/4 of Restlessness tablet Vomiting Zyprexa C 1.25mg- 1 tablet once a day. Date:08/28/03ISR Number: 4187705-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12326120 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 tablet at bedtime. Trazodone Hcl Tabs C Apothecon Neurontin C Lipitor C Amitriptyline C Tramadol C Chlorpheniramine C Celebrex C Azmacort Inhaler C RESPIRATORY (INHALATION) Proventil Inhaler C RESPIRATORY (INHALATION) Albuterol Inhaler C RESPIRATORY 22-Feb-2006 08:31 AM Page: 206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (INHALATION) Date:08/28/03ISR Number: 4187707-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12326997 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4187708-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12327086 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187709-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12327151 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ageusia Abilify Tabs 15 Mg PS Otsuka Diarrhoea Pharmaceutical Weight Decreased Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Lithobid C Glucophage C Bristol-Myers Squibb Company Prempro C Monopril C Bristol-Myers Squibb Company Synthroid C Depakote C Zoloft C Klonopin C Date:08/28/03ISR Number: 4187710-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12327524 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs PS Otsuka Dystonia Pharmaceutical Gait Disturbance Company, Ltd. ORAL dose was decreased on 4-Jun-03 to 2.5 mg daily from 5 mg Inderal C Depakote C Topamax C 22-Feb-2006 08:31 AM Page: 207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187711-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12327599 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Other Syndrome Company, Ltd. ORAL Urinary Incontinence Clonazepam C ORAL Depakote C ORAL Docusate Sodium C ORAL Propranolol C ORAL Trazodone Hcl C Apothecon ORAL Petroleum C each foot at hour of sleep Acetaminophen C Haloperidol C po/im Lorazepam C PO/IM Budenoside C One puff each nostril daily Tolnaftate C powder each foot at hour of sleep Date:08/28/03ISR Number: 4187712-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12327607 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187713-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12328407 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4187714-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12328720 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Date:08/28/03ISR Number: 4187715-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12328779 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 15 Mg PS Otsuka Myalgia Pharmaceutical Company, Ltd. ORAL Ativan C 22-Feb-2006 08:31 AM Page: 208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187716-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12328944 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Parkinsonism Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187717-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12329322 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187718-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12329504 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Irritability Pharmaceutical Restlessness Company, Ltd. ORAL Date:08/28/03ISR Number: 4187719-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12329868 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Mania Pharmaceutical Restlessness Company, Ltd. ORAL Date:08/28/03ISR Number: 4187720-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330098 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dehydration Abilify Tabs 15 Mg PS Otsuka Drug Level Increased Pharmaceutical Oedema Company, Ltd. ORAL 7.5 mg (1/2 of a 15 mg tablet) once daily in the morning Lithobid SS Date:08/28/03ISR Number: 4187721-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330445 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Asthenia Pharmaceutical Other Dystonia Company, Ltd. ORAL Lethargy Abilify Tabs 5 Mg SS Otsuka Tic Pharmaceutical Tremor Company, Ltd. ORAL Concerta C Lexapro C 22-Feb-2006 08:31 AM Page: 209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Date:08/28/03ISR Number: 4187722-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12331468 Age:3 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:08/28/03ISR Number: 4187723-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12331559 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Abilify Tabs PS Otsuka Initial or Prolonged Musculoskeletal Stiffness Pharmaceutical Prescribed Overdose Company, Ltd. ORAL Vision Blurred Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Prozac C Effexor Xr C Neurontin C Zocor C Synthroid C Amantadine C Date:08/28/03ISR Number: 4187724-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12331625 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Abilify Tabs 15 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL 15 mg/day increased to 30 mg/day approximately 3 weeks prior 2 MON Loxapine C Lantus C Humalog C Date:08/28/03ISR Number: 4187725-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12332516 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187726-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12332565 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs PS Otsuka Nausea Pharmaceutical Palpitations Company, Ltd. Vomiting Date:08/28/03ISR Number: 4187727-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12332912 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retinal Pigmentation Abilify Tabs PS Otsuka Visual Disturbance Pharmaceutical Company, Ltd. ORAL Clozaril C Depakote C Effexor C Florinef C King Pharmaceutical Inc. Folic Acid C Lorazepam C Vitamin C C Zinc Sulfate C Date:08/28/03ISR Number: 4187728-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12333274 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify Tabs PS Otsuka Hallucinations, Mixed Pharmaceutical Paranoia Company, Ltd. ORAL Started on 7.5mg once a day in 6/03; 3 weeks ago, increased to Haldol SS Date:08/28/03ISR Number: 4187729-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12333837 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Abilify Tabs PS Otsuka Muscle Spasms Pharmaceutical Company, Ltd. ORAL Ritalin C Clonidine C "0.1 mg in the am and 3 at night" Clonazepam C Keppra C Allergy Medications C "OTC allergy medication for seasonal allergies" 22-Feb-2006 08:31 AM Page: 211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187730-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12333845 Age:7 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187731-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12333944 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 15 Mg PS Otsuka Hypotension Pharmaceutical Syncope Company, Ltd. ORAL 1 DAY Risperdal C 1.0 mg/morning and 1.5 mg/evening Zoloft C Lithium C Date:08/28/03ISR Number: 4187732-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334066 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187733-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334074 Age:7 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4187734-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Klonopin C Date:08/28/03ISR Number: 4187735-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334348 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Abilify Tabs 30 Mg PS Otsuka Dystonia Pharmaceutical Eye Swelling Company, Ltd. increased from 15 mg/day 22-Feb-2006 08:31 AM Page: 212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187736-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334595 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187737-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334678 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs PS Otsuka Myalgia Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4187738-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334959 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Singulair C Detrol C Fosamax C Zestoretic C Effexor Xr C Date:08/28/03ISR Number: 4187739-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12335790 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify Tabs 20 Mg PS Otsuka Swollen Tongue Pharmaceutical Throat Tightness Company, Ltd. ORAL 10 mg/day from 10-Jul-2003, increased to 20 mg/day on Seroquel C 2 YR Neurontin C 1 YR Tranxene C 10 YR Date:08/28/03ISR Number: 4187740-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12336293 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187741-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12336426 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Abilify Tabs 10 Mg PS Otsuka Overdose Pharmaceutical Company, Ltd. Effexor Xr SS Zyprexa SS Date:08/28/03ISR Number: 4187742-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12336525 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Abilify Tabs PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL Date:08/28/03ISR Number: 4187743-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12336715 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/28/03ISR Number: 4187744-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12337507 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs PS Otsuka Visual Disturbance Pharmaceutical Company, Ltd. ORAL Singulair C Allergy Shots C Date:08/28/03ISR Number: 4187745-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12337556 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flushing Abilify Tabs PS Otsuka Musculoskeletal Stiffness Pharmaceutical Tinnitus Company, Ltd. ORAL dosage on 25-Jul-03 was 15 mg, on 27-Jul-03 took 10 mg Flomax C Date:08/28/03ISR Number: 4187746-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12337945 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Oedema Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka 22-Feb-2006 08:31 AM Page: 214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL Wellbutrin Sr C Lexapro C Seroquel C 1 to 3 tablets at hour of sleep Date:08/28/03ISR Number: 4187748-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12338075 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Abilify Tabs PS Otsuka Headache Pharmaceutical Nausea Company, Ltd. ORAL Started Abilify 30 mg daily in Feb-2003,dose decreased to Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Started Abilify 30 mg daily in Feb-2003,dose decreased to Risperdal C Wellbutrin C Date:08/28/03ISR Number: 4187749-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12339131 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL gradually increased to 15 mg daily on 21-Jul-03 from 5 mg Cogentin C Date:08/28/03ISR Number: 4187750-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12342069 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C Date:08/28/03ISR Number: 4187751-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12342143 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Abilify Tabs PS Otsuka Myalgia Pharmaceutical Vision Blurred Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187752-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12342234 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs PS Otsuka Disturbance In Attention Pharmaceutical Insomnia Company, Ltd. ORAL Pt taking 10 mg or 15 mg daily for 2-3 months Seroquel C Levoxyl C Actos C Lipitor C Neurontin C Humulin 70/30 C Date:08/28/03ISR Number: 4187753-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12342481 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Craving Abilify Tabs PS Otsuka Increased Appetite Pharmaceutical Company, Ltd. ORAL 2 MON Date:08/28/03ISR Number: 4187754-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12342507 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL On a "reduced dose" of Abilify Date:08/28/03ISR Number: 4187755-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12342895 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Abilify PS Otsuka Initial or Prolonged Hyperkalaemia Pharmaceutical Hypotension Company, Ltd. Renal Failure Remeron C Klonopin C Zoloft C Date:08/28/03ISR Number: 4187756-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12343182 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs PS Otsuka Depression Pharmaceutical Nervousness Company, Ltd. ORAL 5mg qd,then 7.5mg qd on Jul 2,10mg qd on Jul 5,15mg qd on Jul 12, Abilify Tabs SS Otsuka 22-Feb-2006 08:31 AM Page: 216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL 5mg qd,then 7.5mg qd on Jul 2,10mg qd on Jul 5,15mg qd on Jul 12, Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 5mg qd,then 7.5mg qd on Jul 2,10mg qd on Jul 5,15mg qd on Jul 12, Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 5mg qd,then 7.5mg qd on Jul 2,10mg qd on Jul 5,15mg qd on Jul 12, Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 5mg qd,then 7.5mg qd on Jul 2,10mg qd on Jul 5,15mg qd on Jul 12, Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 5mg qd,then 7.5mg qd on Jul 2,10mg qd on Jul 5,15mg qd on Jul 12, Klonopin C Neurontin C Seroquel C Zyprexa C Topamax C Luvox C Lamictal C Date:08/28/03ISR Number: 4187758-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12343190 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started "last week" Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started "last week" Olanzapine C 22-Feb-2006 08:31 AM Page: 217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4187759-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12354734 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg then reduced to 5 mg Date:08/29/03ISR Number: 4176715-XReport Type:Direct Company Report #CTU 200938 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify 15 Mg. PS ORAL 15 MG ONCE Initial or Prolonged Torticollis ORAL Date:09/03/03ISR Number: 4177959-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12290995 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Reaction Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Xanax SS Cogentin C ORAL Restoril C Zoloft C Date:09/03/03ISR Number: 4177963-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12362711 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Scan Abnormal Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:09/03/03ISR Number: 4181470-3Report Type:Direct Company Report #CTU 201230 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Abilify 20mg PS ORAL QD PO Drug Interaction Paxil 30mg SS ORAL QD PO Insomnia Serotonin Syndrome Somnolence Tremor Date:09/04/03ISR Number: 4178692-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368411 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/03ISR Number: 4179863-3Report Type:Direct Company Report #CTU 201301 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Heart Rate Increased Abilify 10mg PS ORAL 10 MG PO X 1 Intervention to Lethargy Prevent Permanent Nausea Impairment/Damage Ventricular Tachycardia Vomiting Date:09/05/03ISR Number: 4180218-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330429 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Renal Failure Acute Pharmaceutical Rhabdomyolysis Company, Ltd. ORAL Serotonin Syndrome Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Topamax C Effexor C At bedtime Zonegran C Date:09/08/03ISR Number: 4180757-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368684 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Supraventricular Abilify Tabs PS Otsuka Tachycardia Pharmaceutical Company, Ltd. No information was reported Date:09/08/03ISR Number: 4180762-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368635 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Serotonin Syndrome Pharmaceutical Company, Ltd. ORAL Started on 10 mg, increased to 20 mg on 28-Jul-2003. Then Paxil C Dosage was reduced to 30 mg on 30-Jul-2003. Then Date:09/08/03ISR Number: 4180767-0Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12366464 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychosocial Support Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical 22-Feb-2006 08:31 AM Page: 219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Clonazepam C Date:09/08/03ISR Number: 4180769-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367926 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Vomiting Projectile Pharmaceutical Company, Ltd. ORAL Lamictal C Trileptal C 300 mg in a.m. and 600 mg in p.m. Date:09/09/03ISR Number: 4181237-6Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12330957 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Generalised Aripiprazole PS Otsuka Exanthematous Pustulosis Pharmaceutical Company, Ltd. ORAL Date:09/09/03ISR Number: 4181271-6Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12369153 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dysphagia Abilify Tabs 15 Mg PS Otsuka Musculoskeletal Stiffness Pharmaceutical Oropharyngeal Swelling Company, Ltd. ORAL Patient takes 2 (15mg) tablets at bedtime. Date:09/09/03ISR Number: 4181364-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368353 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Event occurred after the second dose. Date:09/10/03ISR Number: 4183003-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12351698 Age:22 YR Gender:Female I/FU:F Outcome PT Disability Anxiety Other Dysphagia Eye Rolling Hyperhidrosis Insomnia Muscle Rigidity Muscle Spasms Parkinsonian Gait 22-Feb-2006 08:31 AM Page: 220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Swollen Tongue Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Reported as taken for "a long time". Date:09/10/03ISR Number: 4183071-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12369310 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Abilify Tabs 30 Mg PS Otsuka Hospitalization - Diarrhoea Pharmaceutical Initial or Prolonged Gastrointestinal Disorder Company, Ltd. ORAL 10mg from Other 25Mar; increased to 15mg on 07Apr; 2 WK Serzone C Bristol-Myers Squibb Company On for "years" Synthroid C Zoloft C Dose increased on 18-Jul-2003 Topamax C 25mg two twice a day Klonopin C On for "years" Tricor C Prilosec C Premarin C Date:09/11/03ISR Number: 4183359-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11709268 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Blinded: Infarction Professional Aripiprazole PS Otsuka Cerebral Haemorrhage Pharmaceutical Cerebrovascular Accident Company, Ltd. ORAL Coma Coumadin SS Bristol-Myers Squibb Coronary Artery Company Atherosclerosis Lasix C Potassium Chloride C Geneva Pharmaceuticals, Inc. (Novartis) Imdur C Vasotec C Multivitamin C Protonix C Keflex C 22-Feb-2006 08:31 AM Page: 221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/03ISR Number: 4186978-2Report Type:Direct Company Report #CTU 201626 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Aripiprazole 15 Mg PS ORAL 15 MG ORAL Intervention to Dystonia Fluphenazine 25 Prevent Permanent Psychomotor Hyperactivity Mg/Ml SS INTRAMUSCULAR 37.5 MG Q 2 Impairment/Damage Sleep Disorder WEEKS IM Date:09/11/03ISR Number: 4186979-4Report Type:Direct Company Report #CTU 201625 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Feeling Jittery Aripirazole 10 Mg PS ORAL 10 MG HS ORAL Intervention to Insomnia Prevent Permanent Impairment/Damage Date:09/12/03ISR Number: 4184624-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371639 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Elliptocytosis Abilify PS Otsuka Pharmaceutical Company, Ltd. No information was provided Date:09/15/03ISR Number: 4185693-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371555 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Abilify Tabs 15 Mg PS Otsuka Blindness Transient Pharmaceutical Company, Ltd. ORAL Patient took only one dose. Effexor Xr C ORAL Clonazepam C ORAL Patient takes one tablet BID Triavil 4-50 C ORAL Patient takes 4/50 one tablet TID and 2 tablets at bedtime 30 YR Date:09/15/03ISR Number: 4185701-5Report Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-12373585 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Murder Abilify Tabs 15 Mg PS Otsuka Psychotic Disorder Pharmaceutical Treatment Noncompliance Company, Ltd. ORAL Patient possibly did not take medication as prescribed 2 WK 22-Feb-2006 08:31 AM Page: 222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/03ISR Number: 4186823-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12373015 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Delirium Pharmaceutical Dysphasia Company, Ltd. ORAL Muscle Rigidity Clozaril C Patient just Neuroleptic Malignant completed a Syndrome 6-week Oral Intake Reduced titration Psychotic Disorder period off Urinary Tract Infection Vomiting Date:09/17/03ISR Number: 4188710-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376281 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Other Hypomania Pharmaceutical Insomnia Company, Ltd. ORAL Six months Paranoia prior to the Prescribed Overdose event, Treatment Noncompliance started on 15mg/day; 6 MON Zoloft C decreased to 100 mg/day Neurontin C Date:09/17/03ISR Number: 4193193-5Report Type:Direct Company Report #CTU 202012 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Abilify (Generics Rash Aripiprazole) PS ORAL 15 MG PO QD Urticaria Famotidine C Folic Acid C Metoclopramide C Multi Vitamin W/Minerals C Quetiapine C Vit B C Date:09/18/03ISR Number: 4189108-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12369310 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Abilify Tabs 30 Mg PS Otsuka Hospitalization - Death Pharmaceutical Initial or Prolonged Diarrhoea Company, Ltd. ORAL 10mg from Other Gastrointestinal Disorder 25Mar; increased to 15mg on 07Apr; 2 WK Serzone C Bristol-Myers Squibb Company On for "years" Synthroid C 22-Feb-2006 08:31 AM Page: 223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Dose increased on 18-Jul-2003 Topamax C 25mg two twice a day Klonopin C On for "years" Tricor C Prilosec C Premarin C Date:09/19/03ISR Number: 4189232-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368635 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Serotonin Syndrome Pharmaceutical Company, Ltd. ORAL Started on 10 mg, increased to 20 mg on 28-Jul-2003. Then Paxil C Dosage was reduced to 30 mg on 30-Jul-2003. Then Depakote C Duration: "several months" Haldol C Duration: "several months" Date:09/19/03ISR Number: 4189236-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12379814 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Abilify PS Otsuka Drooling Pharmaceutical Drug Withdrawal Syndrome Company, Ltd. Date:09/22/03ISR Number: 4194091-3Report Type:Direct Company Report #CTU 202252 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Abilify 5mg Po Qam Musculoskeletal Stiffness (Bristol-Myers Swollen Tongue Squibb) PS Bristol-Myers Squibb ORAL 5MG PO QAM Date:09/22/03ISR Number: 4194174-8Report Type:Direct Company Report #CTU 202248 Age:10 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Dystonia Hiccups 22-Feb-2006 08:31 AM Page: 224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Mydriasis Tachycardia Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify (Aripiprazole) 10 Mg;Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 10 MG PO QD Paxil C Concerta C Depakote C Seroquel C Clonidine C Date:09/23/03ISR Number: 4190636-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368411 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Haemoglobin Decreased Pharmaceutical Haemorrhagic Stroke Company, Ltd. ORAL Hyponatraemia Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Risperidone SS Asa C Ambien C Celebrex C Ditropan Xl C Prevacid C Os-Cal + D C Avapro C Bristol-Myers Squibb Company Miacalcin C NASAL Altace C Discontinued due to hyponatremia Iron C Date:09/24/03ISR Number: 4191795-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12315826 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypochromic Anaemia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Idiopathic Pharmaceutical Other Thrombocytopenic Purpura Company, Ltd. ORAL Started in Increased Tendency To Dec-02, Bruise discontinued Iron Deficiency Anaemia after 2 Rash weeks. Thrombosis Prolixin C Apothecon 22-May-2003: Vaginal Haemorrhage dose reduced Vision Blurred to 5 mg/day 20 YR White Blood Cell Count Cogentin C 20 YR 22-Feb-2006 08:31 AM Page: 225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4192968-6Report Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-12373585 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Abilify Tabs 15 Mg PS Otsuka Murder Pharmaceutical Psychotic Disorder Company, Ltd. ORAL Patient possibly did not take medication as prescribed 2 WK Date:09/24/03ISR Number: 4195562-6Report Type:Direct Company Report #CTU 202381 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify PS Other General Physical Health Zoloft C Deterioration Insulin C Enelapril C Famotidine C Klor-Con /Ef C Date:09/24/03ISR Number: 4195566-3Report Type:Direct Company Report #CTU 202384 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Abilify 10 Mg PS ORAL 10 MG QD ORAL Drooling Lipitor C Tremor Procardia Xl C Weight Increased Quinine Sulfate C So4 C Date:09/24/03ISR Number: 4195748-0Report Type:Direct Company Report #CTU 202406 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Abilify 15mg PS ORAL 7.5MG 2 X Initial or Prolonged Drug Hypersensitivity DAILY ORAL Required Hyperhidrosis Zyrtec C Intervention to Incoherent Ativan C Prevent Permanent Joint Range Of Motion Seroquel C Impairment/Damage Decreased Muscle Rigidity Musculoskeletal Stiffness Date:09/25/03ISR Number: 4196653-6Report Type:Direct Company Report #CTU 202461 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Aripyrazole Initial or Prolonged Drooling (Abilify) PS Feeling Abnormal Nausea Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/03ISR Number: 4196764-5Report Type:Direct Company Report #CTU 202514 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Arpiprazole 15 Mg Intervention to Disorientation (Abilify) Prevent Permanent Speech Disorder Bristol-Myers PS Bristol Myers ORAL 15 MG BID PO Impairment/Damage Date:09/26/03ISR Number: 4195069-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361721 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Excessive Sexual Abilify PS Otsuka Initial or Prolonged Fantasies Pharmaceutical Company, Ltd. ORAL 15 mg/day for 1 week, then increased to 30 mg/day 24 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day for 1 week, then increased to 30 mg/day 24 DAY Ativan C ORAL Colace C Inderal C ORAL Lipitor C Vitamin E C ORAL Zantac C ORAL Date:09/26/03ISR Number: 4195072-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358081 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Abilify PS Otsuka Initial or Prolonged Intentional Overdose Pharmaceutical Other Company, Ltd. No information was provided Date:09/29/03ISR Number: 4197079-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388500 Age:39 YR Gender:Male I/FU:I Outcome PT Death Alanine Aminotransferase Hospitalization - Anxiety Initial or Prolonged Aspartate Aminotransferase Blood Bicarbonate Blood Creatinine Blood Glucose Increased Blood Phosphorus Blood Potassium Blood Urea Brain Death Brain Oedema Haemoglobin 22-Feb-2006 08:31 AM Page: 227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperpyrexia Hypotension Mental Status Changes Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Respiratory Failure Company, Ltd. 2 WK Somnolence Effexor C White Blood Cell Count Topamax C Celexa C Date:09/30/03ISR Number: 4197702-1Report Type:Expedited (15-DaCompany Report #CA-BRISTOL-MYERS SQUIBB COMPANY-12393948 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Aripiprazole PS Otsuka Hospitalization - Orthostatic Hypotension Pharmaceutical Initial or Prolonged Sedation Company, Ltd. ORAL Supraventricular Clozapine SS ORAL 100 mg noon Tachycardia and supper, Syncope 50 mg hs Valproic Acid C present dose 500 mg noon/750 mg hs Pantoprazole C Lorazepam C Lactulose C Date:10/01/03ISR Number: 4198892-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388500 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Abilify PS Otsuka Hospitalization - Aspartate Pharmaceutical Initial or Prolonged Aminotransferase Company, Ltd. Other Band Neutrophil Effexor C Percentage Topamax C Blood Bicarbonate Celexa C Blood Creatinine Blood Phosphorus Blood Potassium Blood Urea Brain Death Brain Oedema Brain Scan Abnormal Glycosuria Haemoglobin Hyperglycaemia Hypotension Lymphocyte Percentage Neuroleptic Malignant Syndrome Neutrophil Percentage Respiratory Failure Somnolence White Blood Cell Count 22-Feb-2006 08:31 AM Page: 228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/03ISR Number: 4198942-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388302 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Abilify PS Otsuka Initial or Prolonged Hypotension Pharmaceutical Loss Of Consciousness Company, Ltd. ORAL Pain In Extremity Klonopin C Tachycardia Topamax C Date:10/01/03ISR Number: 4199234-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11765344 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Aripiprazole PS Otsuka Hospitalization - Rhabdomyolysis Pharmaceutical Initial or Prolonged Sepsis Company, Ltd. ORAL Other Zoloft C Ecotrin C Lopressor C Nitroglycerine C SUBLINGUAL Acetaminophen C ORAL Prazepam C Morphine C Date:10/01/03ISR Number: 4199237-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11987492 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oedema Peripheral Aripiprazole PS Otsuka Other Renal Failure Pharmaceutical Venous Insufficiency Company, Ltd. ORAL blinded phase from 26 Oct 01 to 18 Jan 02 Date:10/01/03ISR Number: 4200115-7Report Type:Direct Company Report #CTU 202888 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depressed Level Of Abilify PS ORAL 10 MG X 1 PO Intervention to Consciousness Paxil C Prevent Permanent Dyskinesia Glucotrol C Impairment/Damage Eye Movement Disorder Vit B12 C Sleep Disorder Feso4 C Tic Zosyn C Tylenol C Ativan C Date:10/01/03ISR Number: 4200647-1Report Type:Direct Company Report #CTU 202948 Age:67 YR Gender:Female I/FU:I Outcome PT Required Depressed Level Of Intervention to Consciousness Prevent Permanent Eye Movement Disorder Impairment/Damage Movement Disorder Sleep Disorder 22-Feb-2006 08:31 AM Page: 229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tic Report Source Product Role Manufacturer Route Dose Duration Abilify PS ORAL 10 MG X 1 PO Paxil C Glucotrol C Vit B12 C Feso4 C Zosyn C Tylenol C Ativan C Date:10/01/03ISR Number: 4200700-2Report Type:Direct Company Report #CTU 202947 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS 10 MG DAILY Life-Threatening Condition Aggravated 5 TO 6 MONTHS Hospitalization - Drug Effect Decreased Buspar C Initial or Prolonged Hallucination, Auditory Neurontin C Suicidal Ideation Lexapro C Date:10/02/03ISR Number: 4200022-XReport Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-12373585 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Abilify PS Otsuka Murder Pharmaceutical Psychotic Disorder Company, Ltd. ORAL Patient Treatment Noncompliance possibly did not take medication as prescribed 2 WK Lamictal C ORAL Zyprexa C Lithium C 600 mg + 900 mg Haloperidol C Valproic Acid C ORAL Date:10/02/03ISR Number: 4200093-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396552 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Abilify PS Otsuka Initial or Prolonged Eye Rolling Pharmaceutical Other Hypersensitivity Company, Ltd. ORAL Hypertonia Muscle Rigidity Swollen Tongue Tremor 22-Feb-2006 08:31 AM Page: 230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/03ISR Number: 4202082-9Report Type:Direct Company Report #CTU 203010 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Mood Abilify PS Otsuka Initial or Prolonged Hallucination Pharmaceutical/Brist Required Hypertension ol-Myers Squibb UNKNOWN? (15 Intervention to Neuroleptic Malignant MG PO QD (?) Prevent Permanent Syndrome Zoloft C Impairment/Damage Paranoia Thinking Abnormal Date:10/03/03ISR Number: 4200921-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12391579 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Abilify Tabs PS Otsuka Initial or Prolonged Gait Disturbance Pharmaceutical Other Heart Rate Increased Company, Ltd. ORAL Started on 15 Hyperhidrosis mg, gradually Hypertension increased to Neuroleptic Malignant 45 mg. No Syndrome exact dates Prescribed Overdose Paxil C taken for Tardive Dyskinesia approximately Urinary Tract Infection 2 years 2 YR Date:10/07/03ISR Number: 4206799-1Report Type:Direct Company Report #CTU 203431E Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Abilify PS 1 TABLET/ DAY Initial or Prolonged Cerebral Cyst Intracranial Pressure Increased Nervous System Disorder Swelling Tremor Date:10/08/03ISR Number: 4208740-4Report Type:Direct Company Report #CTU 203508E Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Abilify PS ORAL 10 MG X 1 PO Intervention to Eye Movement Disorder Paxil C Prevent Permanent Movement Disorder Glucotrol C Impairment/Damage Tic Vit B12 C Feso4 C Zosyn C Tylenol C Ativan C Date:10/09/03ISR Number: 4205122-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217824 Age:86 YR Gender:Female I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:31 AM Page: 231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Aripiprazole PS Otsuka Dysstasia Pharmaceutical Fall Company, Ltd. ORAL Blinded Hip Fracture 31May2002 to 08Aug2002; Open label 09Aug2002 - Furosemide SS Trazodone Hcl SS Apothecon Isosorbide SS Zestril SS Levothyroxine C Potassium C Date:10/09/03ISR Number: 4208880-XReport Type:Direct Company Report #CTU 203591E Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Fluphenazine 10mg PS BID Hospitalization - Syndrome Abilify 15 Mg SS QD; INCREASED Initial or Prolonged 30 QD ; Required INCREASED 15 Intervention to MG Q AM, 30 Prevent Permanent MG QHS Impairment/Damage Date:10/10/03ISR Number: 4205668-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12373015 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Psychotic Disorder Company, Ltd. ORAL 3 MON Urinary Tract Infection Clozaril C Patient just completed a 6-week titration period off Date:10/10/03ISR Number: 4205670-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396495 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Abilify PS Otsuka Drooling Pharmaceutical Dyskinesia Company, Ltd. ORAL Facial Pain Depakote C Dosing Facial Palsy reported as 4 pills 2 times per day Wellbutrin Sr C Adderall C Folic Acid C Armour Thyroid C 22-Feb-2006 08:31 AM Page: 232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/03ISR Number: 4210676-XReport Type:Direct Company Report #CTU 203969E Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Abilify 30mg Hospitalization - Electrocardiogram Qt Bristol-Myers-Squibb PS Bristol-Myers-Squibb ORAL 30MG DAILY Initial or Prolonged Prolonged ORAL Required Respiratory Acidosis Dilantin C Intervention to Torsade De Pointes Ativan C Prevent Permanent Propofol C Impairment/Damage Date:10/16/03ISR Number: 4214406-7Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12318523 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:10/16/03ISR Number: 4214411-0Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12366464 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychosocial Support Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Clonazepam C Date:10/16/03ISR Number: 4214424-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388500 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Glycosuria Abilify PS Otsuka Hospitalization - Hyperglycaemia Pharmaceutical Initial or Prolonged Hypotension Company, Ltd. Other Neuroleptic Malignant Effexor C Syndrome Topamax C Respiratory Failure Celexa C Somnolence Date:10/20/03ISR Number: 4212338-1Report Type:Direct Company Report #CTU 204174 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Abilify Tablets 15 Consciousness Mg (Bristol-Myers Dyspnoea Squibb) PS Bristol-Myers Squibb ORAL 15 MG PO X 1 Lethargy DOSE Medication Error Abilify Tablet 5 Mg SS Mydriasis Zoloft C Atenolol Xl C 22-Feb-2006 08:31 AM Page: 233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/03ISR Number: 4214255-XReport Type:Expedited (15-DaCompany Report #CA-BRISTOL-MYERS SQUIBB COMPANY-12393948 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Aripiprazole PS Otsuka Hospitalization - Orthostatic Hypotension Pharmaceutical Initial or Prolonged Sedation Company, Ltd. ORAL Supraventricular Clozapine SS ORAL 100 mg noon Tachycardia and supper, Syncope 50 mg hs Valproic Acid C present dose 500 mg noon/750 mg hs Pantoprazole C Lorazepam C Lactulose C Date:10/23/03ISR Number: 4215972-8Report Type:Direct Company Report #CTU 204482 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Twitching Abilify PS ORAL 15 MG/PO QAM Musculoskeletal Stiffness Prozac C Levaquin C Flagyl C Benadryl C Date:10/27/03ISR Number: 4219822-5Report Type:Direct Company Report #CTU 204618 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS ORAL 15 MG PO BID Initial or Prolonged Phosphokinase Increased / INCREASED Hypertonia TO 30MG/DAY 1 Mental Status Changes WK AGO Metabolic Acidosis Fioricet C Muscle Rigidity Lexapro C Neuroleptic Malignant Ees C Syndrome Neurontin C Pneumonia Aspiration Welchol C Pyrexia Flexeril C Respiratory Distress Oxycontin C Respiratory Failure Duragesic Patch C Quinine C Protonix C Advair C Vioxx C Asa C Lamisil C Date:10/27/03ISR Number: 4220725-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12357315 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify PS Otsuka Fatigue Pharmaceutical Oedema Peripheral Company, Ltd. ORAL Pallor Abilify SS Otsuka 22-Feb-2006 08:31 AM Page: 234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL Klonopin C Prozac C Buspar C Bristol-Myers Squibb Company Date:10/28/03ISR Number: 4220708-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388302 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Abilify PS Otsuka Initial or Prolonged Hypotension Pharmaceutical Loss Of Consciousness Company, Ltd. ORAL Pain In Extremity Klonopin C Syncope Topamax C Tachycardia Date:10/30/03ISR Number: 4222686-7Report Type:Direct Company Report #CTU 204880 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nausea Abilify PS 10 MG Initial or Prolonged Oral Intake Reduced Asthma C Pancreatitis Vomiting Date:10/31/03ISR Number: 4223302-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12181277 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Abilify Tabs 15 Mg PS Otsuka Other Drug Interaction Pharmaceutical Lung Infection Company, Ltd. ORAL Sleep Apnoea Syndrome Zyprexa C 30 mg (start date not reported)decr eased to 20 mg/day Synthroid C Celexa C Ibuprofen C Albuterol C Depakote C 500 mg AM; 1500 mg at hour of sleep Zithromax I Date:11/04/03ISR Number: 4225994-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368635 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Serotonin Syndrome Pharmaceutical Company, Ltd. ORAL Started on 10 mg, increased to 20 mg on 28-Jul-2003. 22-Feb-2006 08:31 AM Page: 235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Then 13 DAY Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 10 mg, increased to 20 mg on 28-Jul-2003. Then 13 DAY Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 10 mg, increased to 20 mg on 28-Jul-2003. Then 13 DAY Paxil C Dosage was reduced to 30 mg on 30-Jul-2003. Then Depakote C Duration: "several months" Haldol C Taken at bedtime, Duration: "several months" Date:11/04/03ISR Number: 4227784-XReport Type:Direct Company Report #CTU 205245E Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS ORAL 15 MG PO BID Initial or Prolonged Phosphokinase Increased - INCREASED Hypertonia TO 30MG/DAY 1 Mental Status Changes WK AGO Metabolic Acidosis Fioricet C Muscle Rigidity Lexapro C Neuroleptic Malignant Ees C Syndrome Neurontin C Pneumonia Aspiration Welchol C Respiratory Distress Flexeril C Respiratory Failure Oxycontin C Duragesic Patch C Protonix C Vioxx C Asa C Quinine C Advair C Lamisil C Date:11/05/03ISR Number: 4226700-4Report Type:Expedited (15-DaCompany Report #CA-BRISTOL-MYERS SQUIBB COMPANY-12393948 Age:53 YR Gender:Female I/FU:F Outcome PT Life-Threatening Fatigue Hospitalization - Orthostatic Hypotension Initial or Prolonged Sedation Supraventricular 22-Feb-2006 08:31 AM Page: 236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Syncope Report Source Product Role Manufacturer Route Dose Duration Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL 11 DAY Clozapine SS ORAL 100 mg noon and supper, 50 mg hs 6 YR Valproic Acid C present dose 500 mg noon/750 mg hs Pantoprazole C Lorazepam C Lactulose C Date:11/05/03ISR Number: 4226705-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418158 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Encephalitis Company, Ltd. Hypotonia Neurontin C Muscle Rigidity Oxycontin C Neuroleptic Malignant Lexapro C Syndrome Thera-Gesic C Pyrexia Date:11/05/03ISR Number: 4227721-8Report Type:Direct Company Report #CTU 205297 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Body Temperature Aripiprazole PS ORAL 30 MG DAILY Intervention to Increased ORAL Prevent Permanent Extrapyramidal Disorder Risperidone SS ORAL 6 MG DAILY Impairment/Damage Eye Disorder ORAL Eye Movement Disorder Zolpidem C Muscle Rigidity Bupropion C Lorazepam C Trazadone C Date:11/05/03ISR Number: 4227722-XReport Type:Direct Company Report #CTU 205300E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify 10 Mg Initial or Prolonged Deformity Bristol, Myers, Required Dysstasia Squibb PS Bristol, Myers, Intervention to Musculoskeletal Stiffness Squibb ORAL 1/2 TABLET AM Prevent Permanent ORAL Impairment/Damage 22-Feb-2006 08:31 AM Page: 237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/03ISR Number: 4228022-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376281 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Other Hypomania Pharmaceutical Insomnia Company, Ltd. ORAL Six months Paranoia prior to the Prescribed Overdose event, Treatment Noncompliance started on 15mg/day; 6 MON Zoloft C decreased to 100 mg/day Neurontin C Date:11/06/03ISR Number: 4228092-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12391579 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Abilify Tabs PS Otsuka Initial or Prolonged Gait Disturbance Pharmaceutical Other Neuroleptic Malignant Company, Ltd. ORAL Started on 15 Syndrome mg, gradually Prescribed Overdose increased to Tardive Dyskinesia 45 mg. Urinary Tract Infection Paxil C taken for approximately 2 years 2 YR Date:11/06/03ISR Number: 4228094-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367926 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Vomiting Projectile Pharmaceutical Company, Ltd. ORAL Lamictal C Trileptal C 300 mg in a.m. and 600 mg in p.m. Date:11/10/03ISR Number: 4230715-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12423158 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Abilify PS Otsuka Blood Pressure Pharmaceutical Fluctuation Company, Ltd. ORAL Dizziness Depakote C 500 mg - Headache three at Loss Of Consciousness night. Respiratory Arrest Lithium C Zoloft C Lorazepam C Singulair C Diphenhydramine C 2 Tablets of 50 mg at night. Nexium C 22-Feb-2006 08:31 AM Page: 238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin B1 C 1 Every other day. Vitamin B6 C 1 every other day. Vitamin B12 C 1 every other day. Advair Diskus C Every couple of days Date:11/13/03ISR Number: 4234788-XReport Type:Direct Company Report #CTU 206000E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Aripirazole Initial or Prolonged Mania (Abilify) 5 Mg PS ORAL 5 MG PO X ONE Other Olanzapine C Ziprasidone C Date:11/14/03ISR Number: 4235253-6Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12424370 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Abilify PS Otsuka Hypersensitivity Pharmaceutical Rash Papular Company, Ltd. ORAL 4 DAY Rash Pruritic Fluoxetine C ORAL Date:11/14/03ISR Number: 4236532-9Report Type:Direct Company Report #CTU 206177 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Abilify PS 30 MG DAILY Hospitalization - Dialysis Klonopin C Initial or Prolonged Liver Disorder Effexor Er C Disability Renal Impairment Sonata C Rhabdomyolysis Date:11/17/03ISR Number: 4236073-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411849 Age:77 YR Gender:Female I/FU:F Outcome PT Death Activated Partial Hospitalization - Thromboplastin Time Initial or Prolonged Alanine Aminotransferase Anxiety Aspartate Aminotransferase Blood Alkaline Phosphatase Blood Glucose Blood Urea Cardiac Arrest Cerebral Infarction Cerebrovascular Accident Coronary Artery Disease Dehydration Depression 22-Feb-2006 08:31 AM Page: 239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastrooesophageal Reflux Disease General Physical Health Report Source Product Role Manufacturer Route Dose Duration Deterioration Abilify PS Otsuka Haematocrit Pharmaceutical Haemoglobin Company, Ltd. Hyperkalaemia Zoloft C International Normalised Enalapril C Ratio Decreased Famotidine C Lethargy Klor-Con C ORAL Mental Status Changes Celebrex C ORAL Myoglobin Blood Clarinex C ORAL Oral Intake Reduced Cortef C ORAL Pco2 Furosemide C ORAL Platelet Count Norvasc C ORAL Pneumonia Calcium Supplement C ORAL Prothrombin Time Prevacid C ORAL Renal Failure Insulin 70/30 C 30 units qAM Respiratory Rate and 10 units Increased qPM Sepsis Sinus Tachycardia Troponin Urinary Tract Infection Date:11/17/03ISR Number: 4236582-2Report Type:Direct Company Report #CTU 206224 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Ariprazole-Abilify- PS ORAL 15 MG DAY Intervention to Dyskinesia ORAL, 30 MG Prevent Permanent Grimacing DAY ORAL Impairment/Damage Lip Disorder Lexa C Rash Tongue Disorder Vision Blurred Date:11/17/03ISR Number: 4236610-4Report Type:Direct Company Report #CTU 206208 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Feeling Abnormal Abilify 15 Mg Intervention to Movement Disorder Bristol Myers Squibb Prevent Permanent Nervousness Co PS Bristol Myers Squibb Impairment/Damage Speech Disorder Co ORAL PILL 1 X PER Tremor DAY ORAL Date:11/20/03ISR Number: 4238461-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433140 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Dysphemia Pharmaceutical Fall Company, Ltd. ORAL Gait Disturbance Restlessness 22-Feb-2006 08:31 AM Page: 240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/03ISR Number: 4238984-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418158 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Pneumonia Aspiration Company, Ltd. ORAL Neurontin C Oxycontin C Lexapro C Duragesic Patch C Advair C Welchol C Estratest C Vioxx C Flexeril C Protonix C Fioricet C B12 C Quinine C Klonopin C Date:11/21/03ISR Number: 4239232-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433520 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Abilify PS Otsuka Other Myocardial Infarction Pharmaceutical Treatment Noncompliance Company, Ltd. ORAL Ambien C Valium C Lexapro C Lortab C Flovent C Clarinex C Carisoprodol C Date:11/24/03ISR Number: 4239882-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433512 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Abilify PS Otsuka Other Agoraphobia Pharmaceutical Anger Company, Ltd. ORAL 15 mg/day Bipolar Ii Disorder initated on Bladder Prolapse 05-Mar-03; Confusional State increased to Hallucination 30 mg Major Depression Zonegran C Mood Swings Lortab C Panic Disorder Wellbutrin C Post-Traumatic Stress Seroquel C Disorder Lithium C Psychotic Disorder Depakote C Suicidal Ideation Topamax C 22-Feb-2006 08:31 AM Page: 241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4239883-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432993 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Abilify PS Otsuka Other Agoraphobia Pharmaceutical Anger Company, Ltd. ORAL 1/2 - 1 pill Anxiety Disorder Zyprexa C ORAL Initial dose: Claustrophobia 10 mg/day Crying from Depression 07-Jul-2003, Feeling Guilty increased to Insomnia Ambien C ORAL Irritability Lexapro C 1-2 pills/day Major Depression from Mood Swings 07-Jul-03, Panic Disorder 10-20 mg/day Paranoia from Post-Traumatic Stress Trazodone Hcl C Apothecon Disorder Valium C Psychotic Disorder Klonopin C Date:11/24/03ISR Number: 4240154-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12434494 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faeces Discoloured Abilify PS Otsuka Jaundice Pharmaceutical Liver Function Test Company, Ltd. ORAL 10 mg in a.m. Abnormal and 20 mg in Nausea p.m. Oedema Lithobid C Vomiting Trazodone Hcl C Apothecon Rapamune C Lasix C Miralax C Ranitidine C Magnesium Oxide C Date:11/24/03ISR Number: 4240371-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12434080 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Abilify Tabs 15 Mg PS Otsuka Hospitalization - Agitation Pharmaceutical Initial or Prolonged Depressed Mood Company, Ltd. ORAL Therapy Irritability prescribed Mania approx Mood Swings 12-Oct-03;pt Suicide Attempt non Treatment Noncompliance Depakote C since 15 years old Wellbutrin C on/off since 15 yrs old, twice daily for several uears Lamictal C Minocycline C used for 4 to 5 years 22-Feb-2006 08:31 AM Page: 242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4240402-XReport Type:Direct Company Report #CTU 206686 Age:17.8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Abilify Bristol Hospitalization - Blood Amylase Increased Meyers Squibb PS Bristol Meyers Initial or Prolonged Cholelithiasis Squibb ORAL 15 MG BY Other Circulatory Collapse MOUTH 1 TIME Gastroenteritis Viral PER DAY Lipase Increased Effexor C Pancreatitis Acute Vomiting Date:11/24/03ISR Number: 4241278-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174132 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Abilify Tabs PS Otsuka Akathisia Pharmaceutical Constipation Company, Ltd. ORAL 5 mg, inc to Depression 7.5mg; Dissociation decrease to Dizziness 15mg - Fatigue 30Jan03, inc Influenza Like Illness Abilify Tabs SS Otsuka Nausea Pharmaceutical Schizophrenia, Paranoid Company, Ltd. ORAL 5 mg, inc to Type 7.5mg; Sedation decrease to Weight Increased 15mg - 30Jan03, inc Zoloft C Klonopin C Effexor C Lactulose C Provigil C Naproxen C Date:11/24/03ISR Number: 4241280-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238929 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucinations, Mixed Consumer Abilify Tabs 30 Mg PS Otsuka Morbid Thoughts Pharmaceutical Prescribed Overdose Company, Ltd. ORAL 1 MON Social Fear Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL past 90 days from 02-Sep-2003 90 DAY Catapres C Pt takes one tablet TID, on for "couple of years" Zoloft C On medication for "couple of years" Topamax C Dexedrine C 22-Feb-2006 08:31 AM Page: 243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241282-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12300679 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Consumer Abilify Tabs 10 Mg PS Otsuka Drug Ineffective Pharmaceutical Insomnia Company, Ltd. ORAL 10mg tablet- 1/2 tab daily. 3 WK Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Pt rechallenged with 2.5 -5 mg. 2 MON Lamictal C Given at hour of sleep Imipramine C Diazepam C Given every 6 hours prn Depakote C Given at hour of sleep Seroquel C Given at hour of sleep prn Chloral Hydrate C ORAL Given as 1/4 to 1/2 teaspoon at hour of sleep prn Date:11/24/03ISR Number: 4241283-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12304820 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Abilify Tabs 15 Mg PS Otsuka Anxiety Professional Pharmaceutical Neutrophil Count Abnormal Company, Ltd. ORAL Initially White Blood Cell Count stopped on Decreased 02-May-03; rechallenged from 09-Jul Clozapine C Had 2 trials; current Rx has been continous since 7/00; Valproic Acid C Atenolol C Geneva Pharmaceuticals Technology, Corp. Date:11/24/03ISR Number: 4241284-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12309399 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Consumer Abilify Tabs PS Otsuka Drug Interaction Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL increased to Hallucination, Visual 30 mg once daily 2 weeks 22-Feb-2006 08:31 AM Page: 244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ago Lexapro C Risperdal C Depakote C Geodon C Date:11/24/03ISR Number: 4241285-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12321139 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Abilify PS Otsuka Initial or Prolonged Blood Sodium Decreased Professional Pharmaceutical Contusion Company, Ltd. "12 or 15 mg Fall daily" Lethargy Hydrochlorothiazide SS Mental Status Changes Baby Aspirin C Oedema Peripheral Celexa C Diovan C Metformin Hcl C Bristol-Myers Squibb Company Isordil C Minoxidil C Discontinued after 1 or 2 doses. Nitroglycerin Patch C Protonix C Vioxx C Lantus C Albuterol Inhaler C Clonidine C Diltiazem Hcl C Apothecon Date:11/24/03ISR Number: 4241286-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330098 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Abilify Tabs 15 Mg PS Otsuka Dehydration Professional Pharmaceutical Drug Level Increased Company, Ltd. ORAL 7.5 mg (1/2 Medication Error of a 15 mg Oedema tablet) once daily in the morning Lithobid SS Date:11/24/03ISR Number: 4241287-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12334348 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Health Abilify Tabs 30 Mg PS Otsuka Other Dystonia Professional Pharmaceutical Eye Swelling Company, Ltd. ORAL decreased on Joint Contracture 11-Jul-2003 Parkinsonism due to event (dosage not reported) Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL decreased on 22-Feb-2006 08:31 AM Page: 245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 11-Jul-2003 due to event (dosage not reported) Coumadin C Bristol-Myers Squibb Company Date:11/24/03ISR Number: 4241288-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12335790 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Abilify Tabs 20 Mg PS Otsuka Swollen Tongue Professional Pharmaceutical Throat Tightness Company, Ltd. ORAL 10 mg/day from 10-Jul-2003, increased to 20 mg/day on 14 DAY Seroquel C 2 YR Neurontin C 1 YR Tranxene C 10 YR Date:11/24/03ISR Number: 4241289-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12344875 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify Tabs PS Otsuka Dyspepsia Pharmaceutical Nausea Company, Ltd. ORAL Pruritus Lovenox C Rash Ambien C Vomiting Depakote C Klonopin C Date:11/24/03ISR Number: 4241290-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12346565 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:11/24/03ISR Number: 4241291-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12348132 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 7 MON Date:11/24/03ISR Number: 4241292-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12348645 Age:13 YR Gender:Male I/FU:I Outcome PT Akathisia Bipolar Disorder Hostility 22-Feb-2006 08:31 AM Page: 246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose decreased to 10 mg/day during Jun03, then Trileptal C ORAL 18Jul03: Dose increased to 900 mg/morning & 1200 Ddavp C Date:11/24/03ISR Number: 4241293-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12348728 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Abilify Tabs 15 Mg PS Otsuka Orthostatic Hypotension Pharmaceutical Company, Ltd. ORAL 3 WK Uniphyl C Prolixin C Apothecon Cogentin C Date:11/24/03ISR Number: 4241294-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12349460 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241295-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12349577 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Lithium C Date:11/24/03ISR Number: 4241296-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12349619 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify Tabs 10 Mg PS Otsuka Nausea Pharmaceutical Nervousness Company, Ltd. ORAL Somnolence Hydrochlorothiazide C 22-Feb-2006 08:31 AM Page: 247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241297-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12349726 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241298-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12350435 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Risperdal C TAPERING DOSE 4 MON Paxil C 3 MON Date:11/24/03ISR Number: 4241299-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12351250 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 WK Date:11/24/03ISR Number: 4241300-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12351722 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Started Abilify 15 mg daily,then dose decreased to 1 MON Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started Abilify 15 mg daily,then dose decreased to 1 MON Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started Abilify 15 mg daily,then dose decreased to 1 MON Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started Abilify 15 mg daily,then dose decreased to 1 MON Paxil C 22-Feb-2006 08:31 AM Page: 248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ritalin C Minocycline C Date:11/24/03ISR Number: 4241301-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12351748 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241302-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352332 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Abilify Tabs 20 Mg PS Otsuka Irritability Pharmaceutical Company, Ltd. ORAL Initially 5 mg/day, increased over 2 weeks to 20 mg/day. Zyprexa C Tapered off in the beginning of aripiprazole treatment. Date:11/24/03ISR Number: 4241304-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352522 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Abilify Tabs 15 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL On medication for a few days. Dose was decreased to 5mg and Date:11/24/03ISR Number: 4241305-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352530 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Abilify Tabs 5 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241306-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 15 Mg PS Otsuka Muscle Rigidity Pharmaceutical Tongue Disorder Company, Ltd. ORAL 3 WK Phenergan C 22-Feb-2006 08:31 AM Page: 249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241307-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352589 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Furuncle Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Taken for approx 1 and 1/2 months. Physician discontinued, Depakote C Prozac C Klonopin C Ibuprofen C Date:11/24/03ISR Number: 4241308-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352779 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose reduced to 5 mg/day Cogentin C Date:11/24/03ISR Number: 4241309-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352845 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241310-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352936 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Suicide Attempt Pharmaceutical Other Company, Ltd. ORAL 2 MON Ibuprofen C Date:11/24/03ISR Number: 4241311-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12353173 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Abilify PS Otsuka Initial or Prolonged Drug Ineffective Pharmaceutical Company, Ltd. Clozapine SS ORAL 22-Feb-2006 08:31 AM Page: 250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241312-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12353397 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Medication was "put on hold". Date:11/24/03ISR Number: 4241313-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12354221 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Abilify PS Otsuka Heart Rate Increased Pharmaceutical Loss Of Consciousness Company, Ltd. ORAL 1 WK Nausea Neurontin C Vomiting Seroquel C Weight Decreased Paxil C Wellbutrin C Date:11/24/03ISR Number: 4241314-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12354718 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241315-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12354726 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Excitability Abilify PS Otsuka Pharmaceutical Company, Ltd. No information was reported Date:11/24/03ISR Number: 4241316-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12354817 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Depression Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241317-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12355277 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241318-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12355517 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Abilify Tabs PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL 2 WK Prolixin Tabs C Apothecon ORAL Klonopin C 2 MON Depakote C 6 MON Lamictal C 2 YR Neurontin C 2 YR Norvasc C "three months ago" Synthroid C "since before 1/2000" Protonix C 3 MON Date:11/24/03ISR Number: 4241319-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12355723 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241320-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12355756 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematoma Abilify Tabs PS Otsuka Vomiting Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241321-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12355772 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 15 Mg PS Otsuka Drug Level Below Pharmaceutical Therapeutic Company, Ltd. ORAL Date:11/24/03ISR Number: 4241323-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12355822 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Insulin C Strattera C 22-Feb-2006 08:31 AM Page: 252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241324-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12356200 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Duration: 2 to 3 months Date:11/24/03ISR Number: 4241325-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12356283 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Date:11/24/03ISR Number: 4241326-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12357232 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Depakote C Effexor C Klonopin C Date:11/24/03ISR Number: 4241327-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12357422 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 15 Mg PS Otsuka Restless Legs Syndrome Pharmaceutical Thinking Abnormal Company, Ltd. ORAL stable on 15 mg daily for 3 months then discontinued and restarted Date:11/24/03ISR Number: 4241328-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12357661 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs 15 Mg PS Otsuka Dyspnoea Pharmaceutical Fatigue Company, Ltd. ORAL Expiration date: 31-Dec-2004 4 WK Paxil C 1 MON Klonopin C Xanax C 22-Feb-2006 08:31 AM Page: 253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241329-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12357943 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Phase Rhythm Abilify Tabs 10 Mg PS Otsuka Disturbance Pharmaceutical Company, Ltd. ORAL Pt. takes 1/4 of a 10mg tab. Took 1/4 of a tablet only once 1 DAY Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Pt. takes 1/4 of a 10mg tab. Took 1/4 of a tablet only once 1 DAY Benadryl C Seroquel C Xalatan C Darvocet-N 100 C Klonopin C Tegretol C Wellbutrin C Multivitamin C Flaxseed Oil C Eye Drops C Date:11/24/03ISR Number: 4241330-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358016 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Haldol C Trileptal C 300 mg morning + 600 mg evening Cogentin C Lexapro C Date:11/24/03ISR Number: 4241331-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358032 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Restless Legs Syndrome Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241332-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358040 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241333-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358057 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. No information was reported Date:11/24/03ISR Number: 4241334-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358073 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Abilify Tabs PS Otsuka Sedation Pharmaceutical Tardive Dyskinesia Company, Ltd. ORAL Pt inadvertently given 10mg qd x 3 dys,then reduced to Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Pt inadvertently given 10mg qd x 3 dys,then reduced to Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Pt inadvertently given 10mg qd x 3 dys,then reduced to Depakote C Lithium C Date:11/24/03ISR Number: 4241335-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358347 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL "for the last 2 months" 2 MON Risperdal C Date:11/24/03ISR Number: 4241336-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358784 Age:18 YR Gender:Male I/FU:I Outcome PT Anorexia Anxiety Dyskinesia Dyspepsia Nervousness Pruritus Scratch 22-Feb-2006 08:31 AM Page: 255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 15mg, 1 tablet qd in the evening 1 MON Benadryl C Date:11/24/03ISR Number: 4241337-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12358917 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Geodon C Date:11/24/03ISR Number: 4241338-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12359006 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify Tabs 15 Mg PS Otsuka Dysgeusia Pharmaceutical Feeling Abnormal Company, Ltd. ORAL 2 DAY Date:11/24/03ISR Number: 4241339-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12359048 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL No information reported Date:11/24/03ISR Number: 4241340-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12359105 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify Tabs PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL 15 mg initially, increased to 20 mg Eskalith C Klonopin C Seroquel C Inderal La C Synthroid C 22-Feb-2006 08:31 AM Page: 256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241341-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12359121 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C ORAL Remeron C ORAL Androgel C One packet daily Metformin Hcl C Bristol-Myers Squibb Company ORAL Accupril C ORAL Hctz C ORAL Lipitor C ORAL Asa C ORAL Nexium C ORAL Zyprexa C ORAL "7.5mg every hs and 2.5mg daily prn for anxiety" Pt was on prior Date:11/24/03ISR Number: 4241342-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12359857 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241343-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12360129 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphemia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241344-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12360160 Age:6 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241345-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12360186 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify Tabs PS Otsuka Dizziness Pharmaceutical Company, Ltd. ORAL Started on 5 mg on 20-Jun-2003, increased to 22-Feb-2006 08:31 AM Page: 257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 7.5mg on Prozac C Xanax C Ambien C Trazodone Hcl C Apothecon Date:11/24/03ISR Number: 4241346-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12360301 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241347-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361291 Age:9 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241348-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361317 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 10 Mg PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL 5 mg from 05-Aug-2003, increased to 10 mg on 10-Aug-2003 Serzone Tabs C Bristol-Myers Squibb Company Ginkgo Biloba C Date:11/24/03ISR Number: 4241349-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361762 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241350-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361853 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 WK Valium C 22-Feb-2006 08:31 AM Page: 258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241351-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361887 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C Wellbutrin C Prozac C Date:11/24/03ISR Number: 4241352-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361960 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Date:11/24/03ISR Number: 4241353-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12361986 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241354-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12362034 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vertigo Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Interrupted and then restarted Date:11/24/03ISR Number: 4241355-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12362349 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Exfoliative Abilify Tabs 10 Mg PS Otsuka Photosensitivity Reaction Pharmaceutical Sunburn Company, Ltd. ORAL Depakote C Effexor Xr C Lorazepam C Trazodone Hcl C Apothecon Date:11/24/03ISR Number: 4241356-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12362356 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Schizophrenia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241357-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12362489 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241358-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12362497 Age:3 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241359-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12362554 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Abilify PS Otsuka Initial or Prolonged Increased Pharmaceutical Aspartate Company, Ltd. ORAL 3 WK Aminotransferase Lexapro C Increased Vioxx C Back Pain Blood Glucose Increased Rhabdomyolysis Date:11/24/03ISR Number: 4241360-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12363297 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 1 DAY Depakote C Date:11/24/03ISR Number: 4241361-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12363669 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Abilify Tabs 15 Mg PS Otsuka Abnormal Pharmaceutical Company, Ltd. ORAL Possibly 15mg, one tablet daily Date:11/24/03ISR Number: 4241362-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12364071 Age:43 YR Gender:Male I/FU:I Outcome PT Condition Aggravated Dyspnoea Hallucination, Auditory Illusion Paranoia 22-Feb-2006 08:31 AM Page: 260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Schizophrenia Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose increased to 30 mg/day on 12-May-2003. Zyprexa C Decreased: 10 mg on 12May, increased: 15 mg on 20Jun, decreased: Risperdal C Dose increased Depakote C Paxil C Cogentin C Klonopin C Date:11/24/03ISR Number: 4241363-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12364592 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241364-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12365581 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Abilify PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Dose increased to 30 mg/day in Mar03 Depakote C Vitamin E C Trazodone Hcl C Apothecon Spironolactone C Simvastatine C Potassium Chloride C Geneva Pharmaceuticals, Inc. (Novartis) Metformin Hcl C Bristol-Myers Squibb Company Lisinopril C Merck Research Labs Frusemide C Aspirin C Ipratropium + Albuterol C PUFFS 22-Feb-2006 08:31 AM Page: 261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241365-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12365615 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Wellbutrin C Lexapro C Trazodone Hcl Tabs C Apothecon Date:11/24/03ISR Number: 4241366-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12365789 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Psychomotor Hyperactivity Pharmaceutical Restlessness Company, Ltd. ORAL 2 WK Somnolence Ambien C Date:11/24/03ISR Number: 4241367-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12365797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL No information reported Date:11/24/03ISR Number: 4241368-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12365920 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient had samples from her physician Zyprexa C At hour of sleep (hs) Estrace C Apothecon Norvasc C Provera C Oxybutynin C Topamax C Glucophage Xr Tabs C Bristol-Myers Squibb Company Date:11/24/03ISR Number: 4241369-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366068 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Abilify Tabs PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL No information was reported Anafranil C Date:11/24/03ISR Number: 4241370-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366142 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241371-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366357 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241372-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366373 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Lipitor C Date:11/24/03ISR Number: 4241373-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366381 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Decreased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Trazodone Hcl C Apothecon Cogentin C Metformin Hcl C Bristol-Myers Squibb Company Effexor C Avandia C Date:11/24/03ISR Number: 4241374-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366514 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241375-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366670 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241376-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12366738 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. No information was reported Date:11/24/03ISR Number: 4241377-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367165 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ejaculation Disorder Abilify Tabs PS Otsuka Paranoia Pharmaceutical Stress Company, Ltd. ORAL Started on 15mg/Increase d to 30mg/Decrease d to Lopid C Zetia C Klonopin C Norvasc C Multivitamin C Calcium C Vitamin C C Vitamin B Complex C Baby Aspirin C Date:11/24/03ISR Number: 4241378-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367173 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify Tabs 15 Mg PS Otsuka Hallucination, Auditory Pharmaceutical Paranoia Company, Ltd. ORAL Patient taking medication for a "few months" Zyprexa C discontinued then restarted at 20mg once a day. Depakote C 22-Feb-2006 08:31 AM Page: 264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241379-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367199 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify Tabs 15 Mg PS Otsuka Paranoia Pharmaceutical Psychiatric Symptom Company, Ltd. ORAL Patient taking medication for "one month" 1 MON Risperdal C Lithium C Date:11/24/03ISR Number: 4241380-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367751 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Topamax C Ambien C Date:11/24/03ISR Number: 4241381-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367892 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL No information reported Date:11/24/03ISR Number: 4241382-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12367983 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Takes 1/2 of a 10 mg tablet Date:11/24/03ISR Number: 4241383-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368031 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify Tabs 15 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Paxil C Xanax C Toprol Xl C Cozaar C Bristol-Myers Squibb Company Lipitor C 22-Feb-2006 08:31 AM Page: 265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glucophage C Bristol-Myers Squibb Company Prilosec C Vioxx C Date:11/24/03ISR Number: 4241384-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368262 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka White Blood Cell Count Pharmaceutical Increased Company, Ltd. ORAL 4 WK Ambien C Date:11/24/03ISR Number: 4241385-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368304 Age:7 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Health Abilify PS Otsuka Insulin-Dependent Professional Pharmaceutical Company, Ltd. ORAL Insulin C Date:11/24/03ISR Number: 4241386-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368650 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241387-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368726 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient was taking 5mg twice a day Celexa C Aricept C Date:11/24/03ISR Number: 4241388-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368759 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL No information was reported. 22-Feb-2006 08:31 AM Page: 266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241389-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12369286 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241390-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12369351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241391-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12370730 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient took only one dose on an empty stomach Atenolol C Geneva Pharmaceuticals Technology, Corp. Pravachol C Bristol-Myers Squibb Company Meclizine C Potassium C Naproxen C Carbidopa C Bristol-Myers Squibb Company Date:11/24/03ISR Number: 4241393-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12370797 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs 10 Mg PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL Adderall C Prozac C Cogentin C 3 WK Date:11/24/03ISR Number: 4241394-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12370995 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs 15 Mg PS Otsuka Paranoia Pharmaceutical Company, Ltd. ORAL Navane C 27 YR Remeron C Cogentin C 22-Feb-2006 08:31 AM Page: 267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin C Date:11/24/03ISR Number: 4241395-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371191 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241396-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371217 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL No information was reported. Date:11/24/03ISR Number: 4241397-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371233 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Lamictal C Date:11/24/03ISR Number: 4241398-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371241 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241399-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371316 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menstruation Irregular Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL decreased to 15 mg on 09-Jun-2003 Tegretol-Xr C Klonopin C Date:11/24/03ISR Number: 4241400-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371340 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs 30 Mg PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Date:11/24/03ISR Number: 4241401-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371373 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241402-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371381 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Tendency To Abilify Tabs 15 Mg PS Otsuka Bruise Pharmaceutical Company, Ltd. ORAL Lexapro C Clonazepam C Ritalin-Sr C Milk Thistle C Centrum Silver C Coenzyme-Q10 C Date:11/24/03ISR Number: 4241403-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371407 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Adverse Event Abilify Tabs PS Otsuka Constipation Pharmaceutical Crying Company, Ltd. ORAL increased to Disturbance In Attention 30 mg/day Hallucination, Auditory Insomnia Social Avoidant Behaviour Weight Decreased Date:11/24/03ISR Number: 4241404-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371571 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify Tabs PS Otsuka Hallucination Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241405-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371720 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Geodon C 22-Feb-2006 08:31 AM Page: 269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241406-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12372066 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241407-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12372090 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify Tabs 10 Mg PS Otsuka Dizziness Pharmaceutical Energy Increased Company, Ltd. ORAL 1/2 of 10 mg Fall Lithium C Insomnia Klonopin C Nausea Premarin C Vision Blurred Calcium C Multivitamin C Date:11/24/03ISR Number: 4241408-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12372504 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify Tabs 20 Mg PS Otsuka Dyskinesia Pharmaceutical Company, Ltd. ORAL Initial dose was 10 mg/day. Date:11/24/03ISR Number: 4241409-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12372561 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241410-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12372918 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Depakote C Seroquel C Glucotrol C Gabitril C 22-Feb-2006 08:31 AM Page: 270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241412-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12372991 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor Xr C ORAL 4 YR Date:11/24/03ISR Number: 4241413-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12373072 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK Trileptal C Date:11/24/03ISR Number: 4241414-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12373445 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Incoherent Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C ORAL Date:11/24/03ISR Number: 4241415-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12373718 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Patient received two doses. Dose held on 01-Sep-2003 Zoloft C ORAL Pt received 25mg on 30-Aug-2003. Increased to 50 mg on Benadryl C Date:11/24/03ISR Number: 4241416-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12373726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Urine Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241417-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12374211 Age:6 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL 1 DAY Concerta C long-term use Concerta C long-term use Concerta C long-term use Date:11/24/03ISR Number: 4241418-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12374450 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 10 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Wellbutrin C Contraceptive C ORAL Date:11/24/03ISR Number: 4241419-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12374740 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ear Infection Abilify Tabs PS Otsuka Ear Pain Pharmaceutical Insomnia Company, Ltd. ORAL Interrupted Nasal Congestion on Snoring 04-Sep-2003. Increased to 10 mg Synthroid C ORAL For years. YR Date:11/24/03ISR Number: 4241420-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12374997 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241422-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12375085 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Diastolic Abilify Tabs 15 Mg PS Otsuka Increased Pharmaceutical Company, Ltd. ORAL Increased to 30 mg/day on 11-Aug-2003 Klonopin C Seroquel C Prevacid C Remeron C 22-Feb-2006 08:31 AM Page: 272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241423-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12375176 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Abilify Tabs 10 Mg PS Otsuka Confusional State Pharmaceutical Disorientation Company, Ltd. ORAL 1 MON Dizziness Lorazepam C Vaginal Haemorrhage Metoprolol C Zocor C Vitamin E C Multivitamin C Calcium C Calcium + Vitamin D C Darvocet-N 100 C Date:11/24/03ISR Number: 4241424-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376182 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241425-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376323 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify Tabs 10 Mg PS Otsuka Muscle Rigidity Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241426-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376711 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241427-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376737 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241428-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376778 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Depakote C Wellbutrin Sr C 22-Feb-2006 08:31 AM Page: 273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241429-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377032 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Abilify PS Otsuka Blood Pressure Decreased Pharmaceutical Heart Rate Decreased Company, Ltd. ORAL Nausea Date:11/24/03ISR Number: 4241430-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377404 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tinnitus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Started at 5 mg on 13-Aug-2003 and gradually increased to Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Started at 5 mg on 13-Aug-2003 and gradually increased to Prozac C Prevacid C Wellbutrin Sr C Aspirin C Metformin Hcl C Bristol-Myers Squibb Company Trileptal C Xanax C Zyprexa C Calcium Carbonate C Nicotine C TRANSDERMAL Nicotine patches Date:11/24/03ISR Number: 4241431-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377453 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs 10 Mg PS Otsuka Neck Pain Pharmaceutical Pain In Extremity Company, Ltd. ORAL decreased to Pharyngolaryngeal Pain 5 mg/day on 07-Sep-2003 10 DAY Lexapro C Depakote C Cytomel C Date:11/24/03ISR Number: 4241432-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377594 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Risperdal C titrating dose Stelazine C titrating dose Date:11/24/03ISR Number: 4241433-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377628 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Visual Disturbance Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241434-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377917 Age:4 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241435-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377941 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Buspar C Bristol-Myers Squibb Company Effexor C Date:11/24/03ISR Number: 4241436-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12377990 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Other Syndrome Company, Ltd. ORAL Depakote C Serzone C Bristol-Myers Squibb Company Date:11/24/03ISR Number: 4241437-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12378568 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Swelling Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C 22-Feb-2006 08:31 AM Page: 275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241438-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12379236 Age:4 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Discontinued on 27-Aug-2003 or 28-Aug-2003 2 DAY Date:11/24/03ISR Number: 4241439-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12379277 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Discontinued by the patient Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Discontinued by the patient Lamictal C Lexapro C Artane C 1 or 2 times a day Date:11/24/03ISR Number: 4241440-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12379350 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorgasmia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 5mg on Jul-2003, gradually increased to Quetiapine C Lithium C Date:11/24/03ISR Number: 4241441-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12379400 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL at bedtime. Effexor C Klonopin C 22-Feb-2006 08:31 AM Page: 276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241442-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12379442 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Visual Disturbance Pharmaceutical Vomiting Company, Ltd. ORAL 06/03 15 mg daily/increas ed to 30 mg daily/15 mg twice Zyprexa C ORAL Tapered off and discontinued within 1-2 weeks of Trileptal C Geodon C Topamax C Tenex C Buspar C Bristol-Myers Squibb Company Paxil C Concerta C Ddavp C Date:11/24/03ISR Number: 4241443-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12379616 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Depakote C Date:11/24/03ISR Number: 4241444-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12380069 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ulcer Haemorrhage Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241445-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12380200 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241446-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12380549 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Abilify Tabs 10 Mg PS Otsuka Energy Increased Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Nortriptyline C Celexa C Lithium C Wellbutrin C Date:11/24/03ISR Number: 4241447-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12380556 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241448-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12381844 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 2 WK Klonopin C Haloperidol C Date:11/24/03ISR Number: 4241449-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12381943 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor Xr C Risperdal C weaning off. Ativan C Date:11/24/03ISR Number: 4241450-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12382081 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs PS Otsuka Joint Swelling Pharmaceutical Oedema Peripheral Company, Ltd. ORAL Date:11/24/03ISR Number: 4241451-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12382131 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disinhibition Health Aripiprazole PS Otsuka Excessive Masturbation Professional Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241452-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12382503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Faecal Incontinence Pharmaceutical Urinary Incontinence Company, Ltd. ORAL Expiration date Dec-2004 Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Expiration date Dec-2004 Date:11/24/03ISR Number: 4241453-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12382578 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs 15 Mg PS Otsuka Abnormal Dreams Pharmaceutical Insomnia Company, Ltd. ORAL 2 MON Palpitations Rash Pruritic Smoker Weight Increased Date:11/24/03ISR Number: 4241454-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12382883 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium Carbonate C 1 tablet in morning, 2 at night Date:11/24/03ISR Number: 4241455-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12382990 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:11/24/03ISR Number: 4241456-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12383170 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL on Abilify for 2-3 months 22-Feb-2006 08:31 AM Page: 279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241457-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12383345 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL 3 MON Klonopin C Date:11/24/03ISR Number: 4241458-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12383493 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Concerta C Ibuprofen C Lovenox C Date:11/24/03ISR Number: 4241459-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12383758 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Abilify Tabs PS Otsuka Condition Aggravated Pharmaceutical Delusion Company, Ltd. ORAL Duration of Insomnia therapy: 1 to Tardive Dyskinesia 3 months Risperidal C Clozaril C Ativan C Date:11/24/03ISR Number: 4241460-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12383857 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. Duration of therapy: 4 to 6 weeks 4 WK Abilify SS Otsuka Pharmaceutical Company, Ltd. Duration of therapy: 4 to 6 weeks 4 WK Abilify SS Otsuka Pharmaceutical Company, Ltd. Duration of therapy: 4 to 6 weeks 4 WK Prozac C Synthroid C 22-Feb-2006 08:31 AM Page: 280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241461-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12384541 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241462-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12384590 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241463-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12384640 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Generalised Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241465-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12384988 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify Tabs 15 Mg PS Otsuka Joint Stiffness Pharmaceutical Muscle Tightness Company, Ltd. ORAL 10 mg/day from 07-Sep-2003 for one week, increased to Depakote C Wellbutrin C Seroquel C Date:11/24/03ISR Number: 4241466-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12385191 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Date:11/24/03ISR Number: 4241467-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12385399 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Abilify Tabs 30 Mg PS Otsuka Dyskinesia Pharmaceutical Irritability Company, Ltd. ORAL increased to Soliloquy 30 mg/day Navane C Cogentin C 22-Feb-2006 08:31 AM Page: 281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241468-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12385423 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241469-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12385761 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:11/24/03ISR Number: 4241470-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12386751 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Company, Ltd. ORAL No dosing information was provided Date:11/24/03ISR Number: 4241471-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12386785 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Abilify PS Otsuka Initial or Prolonged Heart Rate Decreased Pharmaceutical Other Insomnia Company, Ltd. Date:11/24/03ISR Number: 4241472-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12386850 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241473-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12387015 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241474-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12387163 Age:53 YR Gender:Female I/FU:I Outcome PT Hyperchlorhydria Insomnia 22-Feb-2006 08:31 AM Page: 282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restlessness Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C Ditropan C Lisinopril C Merck Research Labs Provigil C Cyclogyl C OPHTHALMIC Date:11/24/03ISR Number: 4241475-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12387221 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Interrupted, restarted (at 10 mg/day), then discontinued. Date:11/24/03ISR Number: 4241476-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12387247 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thyroid Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241477-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388039 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241478-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388344 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Agitation Pharmaceutical Hostility Company, Ltd. ORAL Over a 10 day period, dosage was increased from 10mg to 22-Feb-2006 08:31 AM Page: 283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241479-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388427 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Abilify PS Otsuka Increased Appetite Pharmaceutical Syncope Company, Ltd. No information was provided Paxil C Moban C Ex-Lax C Date:11/24/03ISR Number: 4241480-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388484 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Abilify PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Phosphokinase Increased Company, Ltd. ORAL Patient was Fear on medication Myalgia for "few weeks" Date:11/24/03ISR Number: 4241481-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12389268 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Started on 15 mg on 20-Aug-2003, increased to 30mg on Zyprexa C ORAL Lexapro C Lorazepam C Pt takes 2mg to 4mg PRN and daily at hour of sleep for "long Date:11/24/03ISR Number: 4241482-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12389557 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Date:11/24/03ISR Number: 4241483-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12389581 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify Tabs 15 Mg PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL took one dose Effexor C Wellbutrin C Date:11/24/03ISR Number: 4241484-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12389888 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Prenatal Vitamins C Date:11/24/03ISR Number: 4241485-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12389938 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Generalised Oedema Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Pt started on 10mg within the last 2wks, increased to Date:11/24/03ISR Number: 4241486-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12389987 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL second dose 21-Sep-2003 Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL second dose 21-Sep-2003 Paxil C Adderall C Trileptal C Date:11/24/03ISR Number: 4241487-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12390019 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Abilify Tabs 15 Mg PS Otsuka Tendon Injury Pharmaceutical Company, Ltd. ORAL Patient was not on the medication at the time of the event. 22-Feb-2006 08:31 AM Page: 285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241488-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12390084 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL duration of therapy: several weeks Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL duration of therapy: several weeks Date:11/24/03ISR Number: 4241489-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12390118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Heart Rate Irregular Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Started on 15mg for 2 weeks then increased to 30mg dose for Date:11/24/03ISR Number: 4241490-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12390308 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Other Convulsion Company, Ltd. ORAL Started on Depressed Level Of 10mg in the Consciousness beginning of Dystonia Jun-2003. Hypoglycaemia Increased to Monoplegia Abilify SS Otsuka Sensory Loss Pharmaceutical Company, Ltd. ORAL Synthroid C 4 YR Insulin C SUBCUTANEOUS 29 Units s.c. per day this past month 1 MON Novolog C SUBCUTANEOUS 50 units s.c. a day for two years 2 YR Date:11/24/03ISR Number: 4241491-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12390712 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241492-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12391041 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 10 Mg PS Otsuka Hyperhidrosis Pharmaceutical Company, Ltd. ORAL Dosage decreased to 5mg on 23-Sep-2003. Date:11/24/03ISR Number: 4241493-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12391355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Insomnia Company, Ltd. Dosage was either 10 mg or 15 mg daily Date:11/24/03ISR Number: 4241494-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12392056 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241495-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12392098 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose reduced to 10 mg/day Date:11/24/03ISR Number: 4241496-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12392338 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 MON Date:11/24/03ISR Number: 4241497-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12392361 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs PS Otsuka Depression Pharmaceutical Company, Ltd. ORAL 1/4 of one 15 mg tablet for 2 days, then 1 day off. 22-Feb-2006 08:31 AM Page: 287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin C Synthroid C Date:11/24/03ISR Number: 4241499-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12392403 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify Tabs PS Otsuka Parkinsonian Gait Pharmaceutical Tremor Company, Ltd. ORAL Paxil C Date:11/24/03ISR Number: 4241500-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12393070 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Dosage: 15mg BID Aricept C Taken at 6:00 p.m. Ativan C Taken at noon, 4:00 p.m. and hour of sleep Zoloft C Sinemet C Bristol-Myers Squibb Company Dosage: 50mg/200mg one tablet every 8 hours Date:11/24/03ISR Number: 4241501-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12393617 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs PS Otsuka Drug Hypersensitivity Pharmaceutical Flushing Company, Ltd. Date:11/24/03ISR Number: 4241502-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12393641 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg in AM and 10 mg in PM Lipitor C Hydrochlorothiazide C Zoloft C Reminyl C Sinemet C Bristol-Myers Squibb Company Aspirin C 22-Feb-2006 08:31 AM Page: 288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flomax C Date:11/24/03ISR Number: 4241503-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12394516 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 15 Mg PS Otsuka Polydipsia Pharmaceutical Company, Ltd. ORAL Prolixin C Apothecon Ritalin C Effexor C Date:11/24/03ISR Number: 4241504-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12394573 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Depakote C Date:11/24/03ISR Number: 4241506-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12394953 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL reduced dose to 3.75 mg/day Date:11/24/03ISR Number: 4241507-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12394961 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 10 Mg PS Otsuka Sluggishness Pharmaceutical Company, Ltd. ORAL Lexapro C Lisinopril C Merck Research Labs Clonazepam C Phentermine C Multivitamin C Date:11/24/03ISR Number: 4241508-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12394995 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241509-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396297 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Abilify PS Otsuka Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Celexa C Date:11/24/03ISR Number: 4241510-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396636 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Drug Effect Decreased Pharmaceutical Hallucination, Auditory Company, Ltd. Dosage gradually increased to 30 mg daily (date started Trileptal C Gradually increased to current dosing (date unknown) Fluvoxamine C Gradually increased to current dosing (date unknown) Date:11/24/03ISR Number: 4241511-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396834 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Jittery Abilify Tabs PS Otsuka Psychomotor Hyperactivity Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241512-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396867 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs PS Otsuka Nausea Pharmaceutical Vomiting Company, Ltd. Duration of therapy: less than 3 weeks. Dose elevated 22-Feb-2006 08:31 AM Page: 290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241513-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396917 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polycythaemia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. No dosing information was provided. Date:11/24/03ISR Number: 4241514-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12397063 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nipple Pain Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Seroquel C Date:11/24/03ISR Number: 4241515-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12397329 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Buspar C Bristol-Myers Squibb Company Klonopin C Date:11/24/03ISR Number: 4241516-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12397865 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Somnolence Pharmaceutical Tachycardia Company, Ltd. ORAL Last dose Tremor taken on 28-Sep-2003; discontinued by Prozac C Strattera C Dexedrine C Tenex C Date:11/24/03ISR Number: 4241517-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12397881 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241518-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12397998 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Abilify Tabs 15 Mg PS Otsuka Oculogyration Professional Pharmaceutical Company, Ltd. ORAL Dose decreased to 7.5 mg/day Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose decreased to 7.5 mg/day Anafranil C Topamax C Initiated 2 to 3 weeks prior to report Date:11/24/03ISR Number: 4241519-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12398491 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erection Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Trazodone Hcl C Apothecon Date:11/24/03ISR Number: 4241520-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12398509 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Insomnia Pharmaceutical Psychotic Disorder Company, Ltd. ORAL increased from 10 mg/day to 20 mg/day to 30 mg/day Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL increased from 10 mg/day to 20 mg/day to 30 mg/day Zoloft C Serevent C Albuterol C Artane C Aspirin C Date:11/24/03ISR Number: 4241521-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12398699 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Effexor C Date:11/24/03ISR Number: 4241522-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12398723 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Paranoia Pharmaceutical Company, Ltd. ORAL Luvox C Trileptal C ORAL Prolixin C Apothecon Date:11/24/03ISR Number: 4241523-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12398731 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage: 5 or 10 mg/day Date:11/24/03ISR Number: 4241524-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12399366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify PS Otsuka Initial or Prolonged Hallucination, Auditory Pharmaceutical Neuroleptic Malignant Company, Ltd. ORAL Dose Syndrome initially 15 mg/day; increased to 15 mg/twice Date:11/24/03ISR Number: 4241525-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12399903 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241527-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12399986 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs PS Otsuka Cold Sweat Pharmaceutical Fatigue Company, Ltd. ORAL Initiated on 20 mg dose for 10 days-2 weeks. 01-Oct-2003 Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated on 22-Feb-2006 08:31 AM Page: 293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 20 mg dose for 10 days-2 weeks. 01-Oct-2003 Neurontin C Celebrex C Minocin C Alprazolam C Diphenhydramine C Fluoxetine C Date:11/24/03ISR Number: 4241528-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12400180 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose reduced to 15 mg/day Date:11/24/03ISR Number: 4241529-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12400602 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Initiatlly on 15 mg/day, increased to 20 mg/day (date or Date:11/24/03ISR Number: 4241530-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12400644 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241531-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12400768 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241532-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12401220 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify Tabs 10 Mg PS Otsuka Dizziness Pharmaceutical Fall Company, Ltd. ORAL Seroquel C Prevacid C 2 YR 22-Feb-2006 08:31 AM Page: 294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zonegran C Taken for the last 4 weeks Albuterol C Synthroid C Taken for about 4 days Date:11/24/03ISR Number: 4241533-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12401295 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241534-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12401311 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Binocular Eye Movement Abilify PS Otsuka Disorder Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241535-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12401337 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/4 tab AM, 1/4 tab @ 12 Noon, 1/2 tab at bedtime Date:11/24/03ISR Number: 4241536-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12401915 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Musculoskeletal Stiffness Pharmaceutical Company, Ltd. ORAL Initially 10 mg/day; decreased to 5 mg/day; increased to Topamax C Date:11/24/03ISR Number: 4241537-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12401949 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs PS Otsuka Musculoskeletal Stiffness Pharmaceutical Company, Ltd. ORAL 10 mg/day, decreased to 5 mg/day, increased to 22-Feb-2006 08:31 AM Page: 295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 10 mg/day Date:11/24/03ISR Number: 4241538-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12401972 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose 15 mg/day, increased to 20 mg or 30 mg. Date:11/24/03ISR Number: 4241539-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12403226 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Abilify Tabs 10 Mg PS Otsuka Feeling Abnormal Pharmaceutical Flat Affect Company, Ltd. ORAL 1/2 of a 10 Loss Of Consciousness mg tablet Migraine Stupor Syncope Date:11/24/03ISR Number: 4241540-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12403390 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 10 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Started begin. of August/ Divided to 5 mg in AM and Celexa C Date:11/24/03ISR Number: 4241541-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12403408 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Aripiprazole PS Otsuka Professional Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241542-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12403507 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241543-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12403689 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Abilify Tabs PS Otsuka Fatigue Pharmaceutical Feeling Jittery Company, Ltd. ORAL Dose reduced Photophobia to 5 mg/day, Vision Blurred then 2.5 mg/day. Celexa C Eskalith Cr C Flomax C Vitamins C Date:11/24/03ISR Number: 4241544-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12403887 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Date:11/24/03ISR Number: 4241545-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12404083 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Risperdal C Date:11/24/03ISR Number: 4241546-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12404109 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5 milligrams 4 MON Zithromax Z-Pak C Lexapro C Ranitidine C Date:11/24/03ISR Number: 4241547-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12404729 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Decreased Appetite Pharmaceutical Dysgeusia Company, Ltd. ORAL Weight Decreased Navane C Zyprexa C 22-Feb-2006 08:31 AM Page: 297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241548-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12404794 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 10 Mg PS Otsuka Muscle Rigidity Pharmaceutical Tremor Company, Ltd. ORAL Originally prescribed 10 mg daily. 04-Oct-2003 increased to Paxil C Seroquel C Cogentin C Metamucil C Multivitamin C Colace C Date:11/24/03ISR Number: 4241549-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405346 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS Otsuka Initial or Prolonged Depressed Level Of Pharmaceutical Consciousness Company, Ltd. 2 MON Dizziness Dystonia Mobility Decreased Transient Ischaemic Attack Date:11/24/03ISR Number: 4241550-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405353 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Sexual Dysfunction Pharmaceutical Company, Ltd. Prolixin C Apothecon Depakote C Date:11/24/03ISR Number: 4241551-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405411 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241552-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405429 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify Tabs 20 Mg PS Otsuka Nausea Pharmaceutical Vomiting Company, Ltd. ORAL Initiated at 20 mg/day, decreased to 22-Feb-2006 08:31 AM Page: 298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 10 mg/day Fosinopril Sodium C Bristol-Myers Squibb Company Atenolol C Geneva Pharmaceuticals Technology, Corp. Baby Aspirin C Trazodone Hcl C Apothecon Synthroid C Date:11/24/03ISR Number: 4241553-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405437 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241554-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405460 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241555-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405668 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage form = 5 mg tablet, 1/2 tablet once per day Depakote C Date:11/24/03ISR Number: 4241556-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12406302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241557-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12406781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 5 or 10 mg/day 22-Feb-2006 08:31 AM Page: 299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241558-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12406815 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241559-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407169 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 10 Mg PS Otsuka Belligerence Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Fear Feeling Abnormal Insomnia Repetitive Speech Date:11/24/03ISR Number: 4241560-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407680 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urine Amphetamine Abilify Tabs PS Otsuka Positive Pharmaceutical Company, Ltd. ORAL Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Inhalers C Ibuprofen C Tylenol C Date:11/24/03ISR Number: 4241561-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407714 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 10 mg tablet Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 10 mg tablet Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 10 mg tablet Risperdal C 22-Feb-2006 08:31 AM Page: 300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241562-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407748 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Insomnia Company, Ltd. Dosage was either 10 mg or 15 mg daily Date:11/24/03ISR Number: 4241563-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407755 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Insomnia Company, Ltd. Dosage was either 10 mg or 15 mg daily Date:11/24/03ISR Number: 4241564-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407763 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Insomnia Company, Ltd. Dosage was either 10 mg or 15 mg daily Date:11/24/03ISR Number: 4241565-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407771 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Insomnia Company, Ltd. Dosage was either 10 mg or 15 mg daily Date:11/24/03ISR Number: 4241566-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407789 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Akathisia Pharmaceutical Insomnia Company, Ltd. Dosage was either 10 mg or 15 mg daily 22-Feb-2006 08:31 AM Page: 301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241567-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407813 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify Tabs PS Otsuka Personality Change Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241568-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407847 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Serzone Tabs C Bristol-Myers Squibb Company Date:11/24/03ISR Number: 4241569-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12407870 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241570-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12408241 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Abilify Tabs PS Otsuka Muscular Weakness Pharmaceutical Company, Ltd. ORAL Dose lowered to 10 mg/day Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose lowered to 10 mg/day Lithium C Lorazepam C Trazodone Hcl C Apothecon Lamictal C Vitamin E C Baby Aspirin C Date:11/24/03ISR Number: 4241571-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12408316 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify Tabs PS Otsuka Overdose Pharmaceutical Psychotic Disorder Company, Ltd. ORAL took 7, 15mg tablets at once. Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL took 7, 15mg tablets at 22-Feb-2006 08:31 AM Page: 302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report once. Date:11/24/03ISR Number: 4241573-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12408456 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241574-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12408480 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify PS Otsuka Abdominal Distension Pharmaceutical Blunted Affect Company, Ltd. ORAL Dosage Depression increased to Dizziness 10 mg daily Headache on Nausea 02-Oct-2003. Palpitations Abilify SS Otsuka Swelling Face Pharmaceutical Company, Ltd. ORAL Dosage increased to 10 mg daily on 02-Oct-2003. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage increased to 10 mg daily on 02-Oct-2003. Paxil C Date:11/24/03ISR Number: 4241575-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12408845 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs 15 Mg PS Otsuka Drug Ineffective Pharmaceutical Dysarthria Company, Ltd. ORAL Incoherent Insomnia Mydriasis Somnolence Weight Increased Date:11/24/03ISR Number: 4241576-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12409900 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify Tabs PS Otsuka Musculoskeletal Stiffness Pharmaceutical Company, Ltd. ORAL Prozac C 22-Feb-2006 08:31 AM Page: 303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241577-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411120 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241578-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411468 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Swelling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil Cr C Nortriptyline C Date:11/24/03ISR Number: 4241579-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411484 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Urinary Retention Pharmaceutical Company, Ltd. ORAL taken at night Celexa C Lithobid C Klonopin C Dexedrine C Date:11/24/03ISR Number: 4241580-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411781 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL taken for 3-4 days Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL taken for 3-4 days Lexapro C Date:11/24/03ISR Number: 4241581-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411807 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Increased Appetite Pharmaceutical Company, Ltd. ORAL Toprol Xl C Tamoxifen C Synthroid C Taxol C Bristol-Myers Squibb Company Altace C 22-Feb-2006 08:31 AM Page: 304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nexium C Valium C Vicodin C Date:11/24/03ISR Number: 4241582-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411898 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241583-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411963 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Abilify Tabs 5 Mg PS Otsuka Swollen Tongue Pharmaceutical Company, Ltd. ORAL Stopped on 18-Jul-2003, restarted on 20-Jul-2003 Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Stopped on 18-Jul-2003, restarted on 20-Jul-2003 Chlorpromazine C Oral or IM Diphenhydramine C 25 to 75 mg IM or oral every 4 hours as necessary Date:11/24/03ISR Number: 4241584-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411989 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241586-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12412342 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alcohol Use Abilify Tabs 15 Mg PS Otsuka Depression Pharmaceutical Hallucination Company, Ltd. ORAL Tardive Dyskinesia Strattera C Lithium C 22-Feb-2006 08:31 AM Page: 305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241587-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12412482 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Phosphokinase Pharmaceutical Other Chest Pain Company, Ltd. ORAL Dyspnoea Risperdal C Tapering off Fatigue Zoloft C Tapering off Joint Stiffness Enteric Coated Myocardial Infarction Aspirin C Rhabdomyolysis Zantac C Humulin C Zestril C Aricept C Date:11/24/03ISR Number: 4241588-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12413340 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241590-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12413944 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Abilify PS Otsuka Initial or Prolonged Epilepsy Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL Risperdal C Zonegran C Lexapro C Date:11/24/03ISR Number: 4241591-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12414009 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241592-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12414645 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Health Abilify PS Otsuka Hypersensitivity Professional Pharmaceutical Urticaria Company, Ltd. ORAL Had been taking aripiprazole for "a couple of months". Cephalosporin SS 22-Feb-2006 08:31 AM Page: 306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241593-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12414678 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241594-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415006 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Acne Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241595-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415030 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Trileptal C Date:11/24/03ISR Number: 4241596-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415139 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Klonopin C at bedtime Celexa C Date:11/24/03ISR Number: 4241597-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415162 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 10 mg/day Jul-2003, increased to 15 mg/day Sep-2003 Depakote C Date:11/24/03ISR Number: 4241598-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415246 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Hallucination Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Clozapine C 22-Feb-2006 08:31 AM Page: 307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241599-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415253 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241600-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415337 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify Tabs 10 Mg PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. ORAL Duration 1-2 days 1 DAY Date:11/24/03ISR Number: 4241601-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415493 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241602-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415501 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241603-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415519 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241604-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415568 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Symptom Abilify Tabs 5 Mg PS Otsuka Depression Pharmaceutical Drug Ineffective Company, Ltd. ORAL durtion 6 or Nausea 7 months. Psychotic Disorder Prozac C Retching Vomiting 22-Feb-2006 08:31 AM Page: 308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241605-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415618 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Abilify PS Otsuka Nervousness Pharmaceutical Palpitations Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Verapmil C Ativan C Date:11/24/03ISR Number: 4241606-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415659 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify PS Otsuka Dysuria Pharmaceutical Company, Ltd. ORAL Risperdal C Date:11/24/03ISR Number: 4241607-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415949 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Concerta C Allegra C Date:11/24/03ISR Number: 4241608-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416160 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Anxiety Pharmaceutical Dystonia Company, Ltd. at bedtime Hyperhidrosis Date:11/24/03ISR Number: 4241609-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416186 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 4 WK Lexapro C Date:11/24/03ISR Number: 4241610-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416228 Age:16 YR Gender:Female I/FU:I Outcome PT Anxiety Dystonia Insomnia 22-Feb-2006 08:31 AM Page: 309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinsonism Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241611-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416244 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Abilify PS Otsuka Initial or Prolonged Pancreatitis Pharmaceutical Company, Ltd. Stopped, restarted, then stopped. Abilify SS Otsuka Pharmaceutical Company, Ltd. Stopped, restarted, then stopped. Effexor Xr C Started at 37.5 mg on 02-Feb-2000, slowly tapered to Date:11/24/03ISR Number: 4241612-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416327 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Buspar C Bristol-Myers Squibb Company Lexapro C Date:11/24/03ISR Number: 4241613-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416368 Age:17 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Lithium C Date:11/24/03ISR Number: 4241614-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416392 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Increased dosage by 5 mg daily to 22-Feb-2006 08:31 AM Page: 310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report total 25 mg daily on Lithium C Synthroid C Diphenhydramine C AT BEDTIME Valium C 1 tablet twice a day and 2 tablets at bedtime Hctz C Centrum Silver C Tylenol Pm C Date:11/24/03ISR Number: 4241615-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416608 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241616-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416624 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Klonopin C Lithium C Date:11/24/03ISR Number: 4241617-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416723 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro SS ORAL Seroquel SS ORAL Date:11/24/03ISR Number: 4241618-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417093 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify Tabs 15 Mg PS Otsuka Parkinsonian Rest Tremor Pharmaceutical Company, Ltd. ORAL Wellbutrin C Klonopin C Lamictal C Interferon C 22-Feb-2006 08:31 AM Page: 311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241619-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417242 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify Tabs 15 Mg PS Otsuka Muscle Spasms Pharmaceutical Tremor Company, Ltd. ORAL Dose = 1/2 of 15 mg tablet, once daily. Duration of therapy: 4 to 4 DAY Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose = 1/2 of 15 mg tablet, once daily. Duration of therapy: 4 to 4 DAY Zoloft C Date:11/24/03ISR Number: 4241620-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417309 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Dyskinesia Pharmaceutical Muscle Rigidity Company, Ltd. ORAL Date:11/24/03ISR Number: 4241621-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417408 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241622-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417622 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241623-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417630 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematemesis Abilify Tabs 15 Mg PS Otsuka Hiccups Pharmaceutical Company, Ltd. ORAL Wellbutrin C 22-Feb-2006 08:31 AM Page: 312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241624-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417846 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematemesis Abilify Tabs 15 Mg PS Otsuka Hiccups Pharmaceutical Company, Ltd. ORAL 1 DAY Wellbutrin C Date:11/24/03ISR Number: 4241625-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417937 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241626-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418604 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Abilify Tabs 15 Mg PS Otsuka Cheilitis Pharmaceutical Dizziness Company, Ltd. ORAL Dry Mouth Abilify Tabs 15 Mg SS Otsuka Hallucination Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Hypoaesthesia Wellbutrin Sr C Rash Navane C Rash Papular Cogentin C Tongue Blistering Remeron C 15 mg in the Urticaria morning, 30 mg at night. Ativan C Taken at night Date:11/24/03ISR Number: 4241627-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418620 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Wellbutrin C Date:11/24/03ISR Number: 4241628-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418638 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Akinesia Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241629-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418836 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241630-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418919 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241631-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418927 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241632-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418935 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241633-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418943 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241634-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418950 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Abilify Tabs PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241635-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12419354 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241636-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12419388 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241637-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12419461 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241638-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12419651 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Orgasm Abnormal Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Inititated at 30 mg/day, dose reduced to 15 mg/day Date:11/24/03ISR Number: 4241639-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12419826 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Posture Abnormal Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241640-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12419883 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose reduced to 10 mg/day on 25-Oct-2003 Zoloft C Strattera C Date:11/24/03ISR Number: 4241642-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420022 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical 22-Feb-2006 08:31 AM Page: 315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Clozapine SS Risperdal C Zoloft C Date:11/24/03ISR Number: 4241643-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420469 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify PS Otsuka Dyspnoea Pharmaceutical Fatigue Company, Ltd. ORAL 1 MON Date:11/24/03ISR Number: 4241644-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420477 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify Tabs 10 Mg PS Otsuka Drug Effect Decreased Pharmaceutical Thinking Abnormal Company, Ltd. ORAL Increased to 15 mg daily for about one week; increased to Date:11/24/03ISR Number: 4241645-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420618 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Hostility Pharmaceutical Mania Company, Ltd. ORAL Patients dosed at 10 and 15 mg. Wellbutrin C Effexor C Date:11/24/03ISR Number: 4241646-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420626 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241647-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420691 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Wellbutrin C Serzone C Bristol-Myers Squibb Company 22-Feb-2006 08:31 AM Page: 316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241648-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420725 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Oedema Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241649-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420824 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241651-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422036 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Craving Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241652-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422051 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg daily (no date reported). Albuterol C Furosemide C Wellbutrin C Zyprexa C Potassium C Tamoxifen C Quinine C Date:11/24/03ISR Number: 4241653-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422077 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241654-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422127 Age: Gender:Male I/FU:I Outcome PT Other Alanine Aminotransferase Increased Aspartate 22-Feb-2006 08:31 AM Page: 317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. 10 mg/day from 04-Jun-2003, increased to 15 mg/day Risperidone C Duration of therapy = over 1 year Gabapentin C Duration of therapy = over 1 year Lorazepam C Duration of therapy = over 1 year Date:11/24/03ISR Number: 4241655-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422465 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241656-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422770 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL After 10 days of therapy, increased to 15 mg daily. Consumer Date:11/24/03ISR Number: 4241657-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422838 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/24/03ISR Number: 4241658-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12423216 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241659-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12423679 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 months ago started aripiprazole 15 mg/decreased Lexapro C Xanax C Date:11/24/03ISR Number: 4241660-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12423950 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241661-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12424388 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Testicular Pain Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Tegretol C Depakote C Date:11/24/03ISR Number: 4241662-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12425195 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Risperdal C Date:11/24/03ISR Number: 4241663-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12425229 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day for 1 week, then increased to 30 mg/day Lamictal C Topamax C Geodon C 22-Feb-2006 08:31 AM Page: 319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241664-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12426102 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aspartate Abilify PS Otsuka Aminotransferase Pharmaceutical Increased Company, Ltd. ORAL Hepatic Enzyme Increased Date:11/24/03ISR Number: 4241665-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12429999 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Acne Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/24/03ISR Number: 4241666-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12430138 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/25/03ISR Number: 4240627-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12435830 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Abilify Tabs 10 Mg PS Otsuka Convulsion Pharmaceutical Coordination Abnormal Company, Ltd. ORAL 5 mg x 5 Disturbance In Attention days, then Eye Pain 2.5 mg, then Facial Pain 1.5 mg Insomnia Trazodone Hcl C Apothecon Neck Pain Date:11/26/03ISR Number: 4241853-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12371555 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient took only one dose. Effexor Xr C ORAL Clonazepam C ORAL Patient takes one tablet BID Triavil 4-50 C ORAL Patient takes 4/50 one tablet TID and 2 tablets at bedtime 30 YR 22-Feb-2006 08:31 AM Page: 320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4241975-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12412060 Age:10 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Drug Level Increased Pharmaceutical Dystonia Company, Ltd. ORAL 6 WK Hiccups Clonidine C ORAL 0.1 mg, 2 Hypertension tablets at Mydriasis bedtime Tachycardia Paxil C ORAL Tremor Concerta C ORAL Depakote C ORAL Seroquel C ORAL Date:12/01/03ISR Number: 4243277-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12436838 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:12/01/03ISR Number: 4243288-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11709268 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Aripiprazole PS Otsuka Infarction Pharmaceutical Cerebral Haemorrhage Company, Ltd. ORAL Cerebrovascular Accident Coumadin SS Bristol-Myers Squibb Coagulation Time Company Prolonged Lasix C Coma Potassium Chloride C Geneva Coronary Artery Pharmaceuticals, Atherosclerosis Inc. (Novartis) Ecchymosis Imdur C Vasotec C Multivitamin C Protonix C Keflex C Date:12/01/03ISR Number: 4243365-6Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12438933 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Phosphokinase Increased Company, Ltd. ORAL Delirium Clozapine C ORAL Drug Level Increased Valium C ORAL Encephalitis Hyperreflexia Muscle Spasms 22-Feb-2006 08:31 AM Page: 321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/03ISR Number: 4243367-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12444022 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 3 MON Date:12/02/03ISR Number: 4245283-6Report Type:Direct Company Report #CTU 207282 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Abilify PS ORAL 10 G DAILY ORAL Depakote C Date:12/03/03ISR Number: 4246365-5Report Type:Direct Company Report #CTU 207413E Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Aripiprazole PS Initial or Prolonged Fluctuation Perphenazine SS Required Neuroleptic Malignant Intervention to Syndrome Prevent Permanent Tachypnoea Impairment/Damage Date:12/03/03ISR Number: 4247060-9Report Type:Direct Company Report #CTU 207426 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Abilify 5mg PS 5 MG AT NIGHT Living Impaired Aricept C Balance Disorder Lethargy Memory Impairment Parkinsonian Gait Tremor Date:12/03/03ISR Number: 4247104-4Report Type:Direct Company Report #CTU 207417 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify 15 Mg PS ORAL 15 MG HS ORAL Date:12/04/03ISR Number: 4247361-4Report Type:Direct Company Report #CTU 207499 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify 15 Mg PS ORAL 15 MG PO Q AM Extrapyramidal Disorder Klonopin C Muscle Rigidity Restlessness 22-Feb-2006 08:31 AM Page: 322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/03ISR Number: 4245882-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12444063 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Abilify PS Otsuka Other Drug Toxicity Pharmaceutical Head Injury Company, Ltd. ORAL Zyprexa SS QHS Risperdal C Klonopin C ORAL Cogentin C ORAL Remeron C ORAL Hydrochlorothiazide C K-Dur C Date:12/09/03ISR Number: 4248970-9Report Type:Direct Company Report #CTU 207752 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Gabapentin PS Initial or Prolonged Dehydration Aripiprazole SS Disorientation Digoxin C Hypotension Bacitracin Mental Status Changes 500/Polumyxin Renal Failure Acute 10000u/Gm C Methadone C Zolmitriptan C Lisinopril C Clonazepam C Aspirin C Insulin Reg Human C Triamcinolone Acetonide C Salsalate C Cpd Men .025% In Euc:Tac 0.1% C Gemfibrizil C Flouoxetine C Fluocinonide C Ammonium Lactate C Allopurinol C Hydroxyzine C Furosemide C Spironolactone C Metoprolol C Date:12/12/03ISR Number: 4250929-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12304416 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Abilify Tabs 15 Mg PS Otsuka Amenorrhoea Pharmaceutical Blood Prolactin Increased Company, Ltd. ORAL increased to Homicidal Ideation 20 mg August Insomnia 2003 Risperdal C Synthroid C Colace C Ativan C Tylenol Pm C 22-Feb-2006 08:31 AM Page: 323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clarinex C "Clarinet" Depakote C Date:12/15/03ISR Number: 4252035-XReport Type:Direct Company Report #CTU 208113 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify 20 Mg Qd Required Parkinson'S Disease Bristol Myers Squibb PS Bristol Myers Squibb ORAL 20 MG QD PO Intervention to Concerta C Prevent Permanent Impairment/Damage Date:12/15/03ISR Number: 4253486-XReport Type:Expedited (15-DaCompany Report #2003120916 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Heart Rate Increased Professional ORAL Other Infusion Site Reaction Aripiprazole Orthostatic Hypotension (Aripiprazole) SS Thrombosis Trazadone (Trazadone) C Date:12/16/03ISR Number: 4252080-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12452264 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Tachycardia Abilify PS Otsuka Sinus Tachycardia Pharmaceutical Supraventricular Company, Ltd. ORAL Initial dose: Tachycardia 7.5 mg/day 1 MON Effexor C Seroquel C Reminyl C Initial dose: 4 mg/twice daily Date:12/16/03ISR Number: 4252234-7Report Type:Direct Company Report #CTU 208155E Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify 30 Mg Bms PS Bms BUCCAL 30 MG Q HS Muscle Rigidity BUCCAL Nausea Metformin C Vomiting Verapamil C Aspirin C Korazepam C Levothyroxinem C Glipizide C Ascorbic Acid C 22-Feb-2006 08:31 AM Page: 324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/03ISR Number: 4252680-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12452348 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Abilify PS Otsuka Initial or Prolonged Cardiac Failure Pharmaceutical Congestive Company, Ltd. ORAL Clozaril C Date:12/17/03ISR Number: 4252681-3Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12438933 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Phosphokinase Increased Company, Ltd. ORAL Delirium Clozapine C ORAL Drug Level Increased Valium C ORAL Encephalitis Hyperreflexia Muscle Spasms Tachycardia Date:12/17/03ISR Number: 4253723-1Report Type:Direct Company Report #CTU 208345 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Back Pain Abilify 10 Mg PS 1/2 PO X 1W Intervention to Headache INCREASED QD Prevent Permanent Muscle Spasms Prozac C Impairment/Damage Muscle Twitching Yasmnin C Myalgia Date:12/19/03ISR Number: 4254865-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12452371 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Accidental Overdose Pharmaceutical Other Coma Company, Ltd. ORAL Patient Fatigue possibly Loss Of Consciousness ingested four Vomiting 15mg tabs Date:12/19/03ISR Number: 4254889-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12418158 Age:45 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Pressure Increased Depressed Level Of Consciousness Encephalitis Haemoglobin Decreased Neuroleptic Malignant Syndrome Platelet Disorder Pneumonia Aspiration 22-Feb-2006 08:31 AM Page: 325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Count Decreased Toxicologic Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Neurontin C Oxycontin C Lexapro C Duragesic Patch C Advair C Welchol C Estratest C Vioxx C Flexeril C Protonix C Fioricet C B12 C Quinine C Klonopin C Acetylsalicilic Acid C Lamisil C Date:12/19/03ISR Number: 4255053-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12422838 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Breast Discharge Abilify PS Otsuka Breast Haemorrhage Pharmaceutical Company, Ltd. ORAL 1 MON Date:12/19/03ISR Number: 4255056-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12452215 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Abilify Tabs PS Otsuka Oedema Mouth Pharmaceutical Swelling Face Company, Ltd. ORAL 1 DAY Swollen Tongue Date:12/23/03ISR Number: 4257066-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12287546 Age:21 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acidosis Initial or Prolonged Atrial Fibrillation Other Blood Creatine Phosphokinase Increased Bradycardia Coma Electrocardiogram Qrs Complex Prolonged Electrocardiogram Qt Prolonged Hypotension Overdose Pneumonia Aspiration Respiratory Arrest 22-Feb-2006 08:31 AM Page: 326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Status Epilepticus Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Health Abilify Tabs 15 Mg PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Zantac C Lexapro C Date:12/23/03ISR Number: 4258561-1Report Type:Direct Company Report #CTU 208696E Age:13 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify 15 Mg PS Dystonia Extrapyramidal Disorder Date:12/29/03ISR Number: 4259426-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12459665 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:12/31/03ISR Number: 4261090-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12396917 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Abilify Tabs PS Otsuka Initial or Prolonged Increased Professional Pharmaceutical Hepatic Steatosis Company, Ltd. ORAL started at 15 Liver Function Test mg, decreased Abnormal to 10 mg, Nausea increased to Polycythaemia 15 mg, & 30 DAY Risperdal C Date:12/31/03ISR Number: 4263080-2Report Type:Direct Company Report #CTU 208996 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify 15mg Insomnia Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 30 MG BEDTIME ORAL Vioxx C Nexium C 22-Feb-2006 08:31 AM Page: 327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin Sr C Clonazepam C Ditropan Xl C Nasonex C Depakote C Allegra-D C Fosamax C Imitrex C Esgic Plus Butalbital/Apap/Caff eine C Aspirin C Ibuprophen C Date:01/04/04ISR Number: 4263274-6Report Type:Direct Company Report #CTU 209248 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Swelling Abilify 30mg PS ORAL 30MG DAILY Pruritus ORAL Tinnitus Asa C Paxil C Lipitor C Dilantin C Clonazepam C Date:01/05/04ISR Number: 4262968-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12464624 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Abilify PS Otsuka Other Pharmaceutical Company, Ltd. Date:01/05/04ISR Number: 4263209-6Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12314241 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Aripiprazole PS Otsuka Initial or Prolonged Delusion Professional Pharmaceutical Mania Company, Ltd. ORAL Paroxetine C Zopiclone C Date:01/05/04ISR Number: 4263508-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12423612 Age:59 YR Gender:Female I/FU:F Outcome PT Life-Threatening Catatonia Hospitalization - Coma Initial or Prolonged Ejection Fraction Decreased Electrocardiogram Qt Prolonged Embolic Stroke Grand Mal Convulsion International Normalised 22-Feb-2006 08:31 AM Page: 328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ratio Decreased Respiratory Acidosis Torsade De Pointes Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal SS Norvasc C Coumadin C Bristol-Myers Squibb Company Potassium C Lasix C Glipizide C Prozac C Coreg C Date:01/06/04ISR Number: 4264465-0Report Type:Direct Company Report #CTU 209356E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Aripiprazole-Abil 30 Initial or Prolonged Rhabdomyolysis Mg Bristol Myers Squibb PS ORAL 30 MG DAILY ORAL Date:01/07/04ISR Number: 4265998-3Report Type:Direct Company Report #CTU 209502 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify PS Drug Effect Decreased Topamax SS Drug Interaction Date:01/08/04ISR Number: 4266833-XReport Type:Direct Company Report #CTU 209552E Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Acne Abilify 15 Mg Intervention to Constipation Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 15 MG DAILY Prevent Permanent Dyskinesia ORAL Impairment/Damage Fear Lexapro 20 Mg Forest Glucose Tolerance Pharmaceuticals SS Forest Impaired Pharmaceuticals ORAL 20 MG DAILY Insulin Resistance ORAL Morbid Thoughts Nightmare Polycystic Ovaries Sleep Disorder Thinking Abnormal Weight Increased 22-Feb-2006 08:31 AM Page: 329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/04ISR Number: 4267486-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12459665 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Health Abilify PS Otsuka Throat Tightness Professional Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Date:01/09/04ISR Number: 4268131-7Report Type:Direct Company Report #CTU 209628E Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grimacing Abilify 5 Mg Initial or Prolonged Movement Disorder Bristol-Meyers Muscle Tightness Squibb PS Bristol-Meyers Squibb ORAL 5 MG BID ORAL Date:01/12/04ISR Number: 4268675-8Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12366464 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychosocial Support Health Aripiprazole PS Otsuka Initial or Prolonged Social Problem Professional Pharmaceutical Company, Ltd. ORAL Clonazepam C Date:01/12/04ISR Number: 4268790-9Report Type:Expedited (15-DaCompany Report #RU-BRISTOL-MYERS SQUIBB COMPANY-12474540 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Aripiprazole PS Otsuka Initial or Prolonged Condition Aggravated Professional Pharmaceutical Delusion Company, Ltd. ORAL Schizophrenia Date:01/12/04ISR Number: 4268841-1Report Type:Direct Company Report #CTU 209689E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Insomnia Aripiprazole 20 Mg PS ORAL 20 MG AM ORAL Intervention to Prevent Permanent Impairment/Damage Date:01/12/04ISR Number: 4269709-7Report Type:Expedited (15-DaCompany Report #2003127320 Age: Gender:Male I/FU:I Outcome PT Disability Akathisia Bedridden 22-Feb-2006 08:31 AM Page: 330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Drug Interaction Fatigue Report Source Product Role Manufacturer Route Dose Duration Consumer Zoloft (Sertraline) PS Aripiprazole (Aripiprazole) SS ORAL ORAL Date:01/13/04ISR Number: 4270335-4Report Type:Direct Company Report #CTU 209974E Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nocturia Aripiprazole PS ORAL 15 MG PO QD Date:01/13/04ISR Number: 4270560-2Report Type:Direct Company Report #CTU 209968 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Aripiprazole 10 Mg Mania Otsuka PS Otsuka ORAL 10MG DAILY ORAL Date:01/15/04ISR Number: 4271428-8Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12330957 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Generalised Health Aripiprazole PS Otsuka Exanthematous Pustulosis Professional Pharmaceutical Company, Ltd. ORAL Date:01/15/04ISR Number: 4272353-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12470969 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Abilify PS Otsuka Consciousness Pharmaceutical Hypothermia Company, Ltd. Date:01/16/04ISR Number: 4273182-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472726 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:01/20/04ISR Number: 4274137-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12474573 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Self-Injurious Ideation Professional Pharmaceutical Company, Ltd. ORAL 15 mg 05-Dec-03; then 30 mg 06-Jan-04 22-Feb-2006 08:31 AM Page: 331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone C Sertraline C Date:01/20/04ISR Number: 4277014-8Report Type:Direct Company Report #CTU 210455 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Abilify 15mg PS ORAL 15 MG BID PO Dystonia Seroquel C Tongue Disorder Paxil C Ortho Triclyclen C Date:01/22/04ISR Number: 4277429-8Report Type:Expedited (15-DaCompany Report #RU-BRISTOL-MYERS SQUIBB COMPANY-12474540 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Aripiprazole PS Otsuka Initial or Prolonged Delusion Professional Pharmaceutical Schizophrenia Company, Ltd. ORAL Date:01/22/04ISR Number: 4277437-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12304416 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Abilify Tabs 15 Mg PS Otsuka Blood Prolactin Increased Pharmaceutical Depressed Mood Company, Ltd. ORAL increased to Homicidal Ideation 20 mg August Insomnia 2003 Menstrual Disorder Risperdal C Obsessive Thoughts Synthroid C Suicidal Ideation Colace C Ativan C Tylenol Pm C Clarinex C "Clarinet" Depakote C Date:01/22/04ISR Number: 4277490-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411815 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Altered Visual Depth Abilify PS Otsuka Initial or Prolonged Perception Pharmaceutical Disorientation Company, Ltd. ORAL Initial Dizziness dosage was Extrapyramidal Disorder 7.5mg daily Hyperhidrosis (19-Jun), Hypersensitivity increased to Incoherent Seroquel C On 19-Jun-2003 dosage was decreased to 100 mg daily Zyrtec C Ativan C 22-Feb-2006 08:31 AM Page: 332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/04ISR Number: 4277516-4Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12318523 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Date:01/23/04ISR Number: 4277930-7Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12314241 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Aripiprazole PS Otsuka Initial or Prolonged Drug Ineffective Professional Pharmaceutical Mania Company, Ltd. ORAL Paroxetine C Zopiclone C Date:01/23/04ISR Number: 4278216-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472643 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Health Aripiprazole PS Otsuka Initial or Prolonged Thromboplastin Time Professional Pharmaceutical Prolonged Company, Ltd. ORAL Anaphylactic Reaction Perphenazine C Asthma Nph Insulin C 25 units qAM, Blood Creatinine 50 units qPM Increased Regular Insulin C Before Blood Fibrinogen breakfast Increased Rosiglitazone C Blood Glucose Increased Lisinopril C Blood Pressure Simvastatin C qhs Fluctuation Depakote C Bronchitis Zoloft C Cellulitis Dermatitis Exfoliative Haematocrit Decreased Haemoglobin Decreased Hypoalbuminaemia Hypoproteinaemia Hypotension International Normalised Ratio Increased Metabolic Acidosis Neuroleptic Malignant Syndrome Prothrombin Time Prolonged Sepsis Tachypnoea Urinary Tract Infection Date:01/23/04ISR Number: 4278310-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479754 Age:21 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Conversion Disorder Abilify Tabs 30 Mg PS Otsuka Depression Pharmaceutical Overdose Company, Ltd. ORAL "all at one Suicidal Ideation time" Suicide Attempt Depakote C "for a couple Tremor of years" Haldol C "for a couple of years" Cogentin C "for a couple of years" Lithobid C Date:02/03/04ISR Number: 4284238-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411849 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Abilify PS Otsuka Hospitalization - Cardiac Arrest Professional Pharmaceutical Initial or Prolonged Cerebrovascular Accident Company, Ltd. Other Coronary Artery Disease Zoloft C Dehydration Enalapril C Dementia Famotidine C Dementia Alzheimer'S Type Klor-Con C ORAL Depression Celebrex C ORAL Dyskinesia Clarinex C ORAL Flat Affect Cortef C ORAL Gastrooesophageal Reflux Furosemide C ORAL Disease Norvasc C ORAL Hyperkalaemia Calcium Supplement C ORAL Hypertension Prevacid C ORAL Mental Status Changes Insulin 70/30 C 30 units qAM Mobility Decreased and 10 units Peripheral Vascular qPM Disorder Renal Failure Date:02/03/04ISR Number: 4284402-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12484739 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antepartum Haemorrhage Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL Paxil Cr C Date:02/04/04ISR Number: 4286153-7Report Type:Direct Company Report #CTU 211501 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lymphadenopathy Abiliffy 5 Mg PS ORAL 5 MG DAILY Intervention to Pyrexia ORAL Prevent Permanent Rash Generalised Lithium Carbonate C Impairment/Damage Olanzapine C Fluvoxamine C Guanfacine C 22-Feb-2006 08:31 AM Page: 334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4285765-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472643 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Health Aripiprazole PS Otsuka Initial or Prolonged Blood Creatinine Professional Pharmaceutical Increased Company, Ltd. ORAL Blood Glucose Increased Perphenazine SS Cellulitis Nph Insulin C 25 units qAM, Clostridium Colitis 50 units qPM Dermatitis Exfoliative Regular Insulin C Before Haemoglobin Decreased breakfast Hypoalbuminaemia Rosiglitazone C Hypoproteinaemia Lisinopril C Metabolic Acidosis Simvastatin C qhs Neuroleptic Malignant Depakote C Syndrome Zoloft C Staphylococcal Bacteraemia Urinary Tract Infection Date:02/05/04ISR Number: 4286136-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491015 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/05/04ISR Number: 4286428-1Report Type:Direct Company Report #CTU 211663 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Aripiprazole 20 Mg PS ORAL 20 MG QHS PO Intervention to Fall Prevent Permanent Impairment/Damage Date:02/06/04ISR Number: 4286504-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488219 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Mania Pharmaceutical Schizoaffective Disorder Company, Ltd. Clozapine C Date:02/06/04ISR Number: 4290280-8Report Type:Direct Company Report #CTU 211722 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Abilify 10 Mg Intervention to Bristol Myer Squibb PS Bristol Myer Squibb ORAL 10 MG QD Prevent Permanent ORAL Impairment/Damage 22-Feb-2006 08:31 AM Page: 335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/04ISR Number: 4288892-0Report Type:Direct Company Report #CTU 211850 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Zoloft 200mg/Day PS ORAL 200MG Feeling Abnormal ONCE/DAY ORAL Restlessness Abilify 30 Mg/Day SS ORAL 30 MG Tremor ONCE/DAY ORAL Fluoxetine SS Date:02/09/04ISR Number: 4289883-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12474573 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Health Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Professional Pharmaceutical Self-Injurious Ideation Company, Ltd. ORAL 15 mg 05-Dec-03; then 30 mg 06-Jan-04 Zopiclone C Sertraline C Date:02/11/04ISR Number: 4290874-XReport Type:Expedited (15-DaCompany Report #RU-BRISTOL-MYERS SQUIBB COMPANY-12474540 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Aripiprazole PS Otsuka Initial or Prolonged Delusion Pharmaceutical Hostility Company, Ltd. ORAL Schizophrenia Date:02/11/04ISR Number: 4290888-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433140 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Dysphemia Pharmaceutical Fall Company, Ltd. ORAL Gait Disturbance Clonazepam C Restlessness Date:02/11/04ISR Number: 4291434-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12434080 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Abilify Tabs 15 Mg PS Otsuka Hospitalization - Agitation Pharmaceutical Initial or Prolonged Depressed Mood Company, Ltd. ORAL Therapy Irritability prescribed Mania approx Mood Swings 12-Oct-03;pt Suicide Attempt non Treatment Noncompliance Depakote C since 15 years old Wellbutrin C on/off since 15 yrs old, twice daily 22-Feb-2006 08:31 AM Page: 336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report for several uears Lamictal C Minocycline C used for 4 to 5 years Date:02/12/04ISR Number: 4293668-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12424370 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL 4 DAY Fluoxetine C ORAL Date:02/12/04ISR Number: 4293670-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494852 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify PS Otsuka Initial or Prolonged Accidental Overdose Pharmaceutical Other Lethargy Company, Ltd. Medication Error Respiratory Rate Increased Tremor Date:02/12/04ISR Number: 4293676-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12497236 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Abilify PS Otsuka Initial or Prolonged Lethargy Pharmaceutical Other Medication Error Company, Ltd. Respiratory Rate Increased Tremor Date:02/12/04ISR Number: 4293678-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432993 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Abilify PS Otsuka Other Coronary Artery Professional Pharmaceutical Atherosclerosis Company, Ltd. ORAL 1/2 - 1 pill 2 MON Depression Zyprexa C ORAL Initial dose: Drug Abuser 10 mg/day Mood Swings from Sleep Disorder 07-Jul-2003, increased to Ambien C ORAL Lexapro C 1-2 pills/day from 07-Jul-03, 10-20 mg/day from Trazodone Hcl C Apothecon Valium C 22-Feb-2006 08:31 AM Page: 337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Date:02/12/04ISR Number: 4293679-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433520 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Abilify PS Otsuka Other Hypertensive Heart Professional Pharmaceutical Disease Company, Ltd. ORAL 5 MON Myocardial Infarction Ambien C Treatment Noncompliance Valium C Lexapro C Lortab C Flovent C Clarinex C Carisoprodol C Date:02/12/04ISR Number: 4293805-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433512 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Abilify PS Otsuka Other Agoraphobia Professional Pharmaceutical Anger Company, Ltd. ORAL 15 mg/day Bipolar Ii Disorder initated on Bladder Prolapse 05-Mar-03; Confusional State increased to Depression 30 mg 6 MON Drug Toxicity Methadone SS Hallucination Fluoxetine SS Intervertebral Disc Zonegran C Disorder Lortab C Major Depression Wellbutrin C Mood Swings Seroquel C Panic Disorder Lithium C Post-Traumatic Stress Depakote C Disorder Topamax C Psychotic Disorder Suicidal Ideation Date:02/12/04ISR Number: 4293807-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495222 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Date:02/12/04ISR Number: 4293945-7Report Type:Direct Company Report #CTU 212146 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify 15 Mg Initial or Prolonged Bristol PS Bristol ORAL 15 MG PO ORAL 22-Feb-2006 08:31 AM Page: 338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/04ISR Number: 4296087-XReport Type:Direct Company Report #CTU 212242 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Zoloft 200 Mg/Day PS ORAL 200 MG Feeling Abnormal ONCE/DAY ORAL Restlessness Abilify 30mg/Day SS ORAL 30MG ONCE/DAY Tremor ORAL Date:02/17/04ISR Number: 4296466-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498036 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Abilify PS Otsuka Head Banging Pharmaceutical Intentional Self-Injury Company, Ltd. ORAL Trileptal C Risperdal C Contraceptive C Date:02/17/04ISR Number: 4296470-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495974 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Abilify PS Otsuka Initial or Prolonged Hypothermia Pharmaceutical Platelet Count Decreased Company, Ltd. ORAL White Blood Cell Count Clonazepam C Decreased Date:02/17/04ISR Number: 4296898-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472726 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Date:02/17/04ISR Number: 4297558-2Report Type:Direct Company Report #CTU 212490 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilitify 15 Mg PS ORAL ONE QD ORAL Sensory Loss Date:02/17/04ISR Number: 4297778-7Report Type:Direct Company Report #CTU 212447 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gait Disturbance Aripiprazole 15mg Intervention to Tremor Abilify PS ORAL 15MG QD ORAL Prevent Permanent Metformin C Impairment/Damage Aspirin C Glipizide Xl C Novolin R C Chlorpromazine C Vit And D Oint C 22-Feb-2006 08:31 AM Page: 339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Betamethasone C Date:02/17/04ISR Number: 4299182-4Report Type:Direct Company Report #CTU 212469 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Abilify 20 Mg Tab PS Bristol Myer Squibb Initial or Prolonged Dysphagia Company ORAL 10 MG PO BID Lethargy Adderal C Muscle Rigidity Trazodone C Parkinson'S Disease Stupor Tongue Paralysis Tremor Date:02/19/04ISR Number: 4299579-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457354 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Abilify PS Otsuka Initial or Prolonged Cholecystectomy Pharmaceutical Other Dehydration Company, Ltd. ORAL 9 MON Dyskinesia Abilify SS Otsuka Eye Rolling Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL 9 MON Mental Disorder Prozac C Pregnancy Vomiting Date:02/19/04ISR Number: 4299580-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12499885 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Abilify PS Otsuka Pregnancy Pharmaceutical Systemic Lupus Company, Ltd. ORAL Erythematosus Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Date:02/20/04ISR Number: 4300231-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491015 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/23/04ISR Number: 4301610-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508529 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Abilify PS Otsuka Initial or Prolonged Dystonia Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/04ISR Number: 4301613-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508636 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Abilify PS Otsuka Initial or Prolonged Dystonia Pharmaceutical Company, Ltd. Date:02/23/04ISR Number: 4301614-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508628 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Abilify PS Otsuka Initial or Prolonged Dystonia Pharmaceutical Company, Ltd. Date:02/25/04ISR Number: 4303614-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12485546 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Insomnia Abilify PS Otsuka Mania Pharmaceutical Penile Pain Company, Ltd. ORAL Dose lowered on 25-Feb-2004, then discontinued Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose lowered on 25-Feb-2004, then discontinued Levoxyl C Mysoline C Aspirin C Bextra C Risperidal C Pletal C Zonegran C Altace C Chlor-Trimeton C Pepcid C Date:02/26/04ISR Number: 4305473-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12136719 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Nervousness Pharmaceutical Psychomotor Hyperactivity Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Trazodone Hcl C Apothecon 22-Feb-2006 08:31 AM Page: 341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305474-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12238929 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Consumer Abilify Tabs 30 Mg PS Otsuka Hallucination Pharmaceutical Morbid Thoughts Company, Ltd. ORAL 1 MON Prescribed Overdose Abilify Tabs 30 Mg SS Otsuka Social Fear Pharmaceutical Company, Ltd. ORAL past 90 days from 02-Sep-2003 90 DAY Catapres C Pt takes one tablet TID, on for "couple of years" Zoloft C On medication for "couple of years" Topamax C Dexedrine C Date:02/26/04ISR Number: 4305475-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12336426 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Effect Health Abilify Tabs 10 Mg PS Otsuka Overdose Professional Pharmaceutical Company, Ltd. ORAL Effexor Xr SS ORAL Zyprexa SS ORAL Date:02/26/04ISR Number: 4305476-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352589 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Furuncle Consumer Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Taken for approx 1 and 1/2 months. Physician discontinued, Depakote C Prozac C Klonopin C Ibuprofen C Date:02/26/04ISR Number: 4305477-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352936 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Suicide Attempt Professional Pharmaceutical Other Company, Ltd. ORAL 2 MON Ibuprofen C 22-Feb-2006 08:31 AM Page: 342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305478-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12360301 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL 7 MON Date:02/26/04ISR Number: 4305479-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12383758 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Abilify Tabs PS Otsuka Aggression Pharmaceutical Delusion Company, Ltd. ORAL Duration of Sleep Disorder therapy: 1 to Tardive Dyskinesia 3 months Risperidal C Clozaril C Ativan C Date:02/26/04ISR Number: 4305480-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12387163 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperchlorhydria Consumer Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceutical Restlessness Company, Ltd. ORAL 1 MON Celexa C Ditropan C Lisinopril C Provigil C Cyclogyl C OPHTHALMIC Date:02/26/04ISR Number: 4305481-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12388344 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Abilify PS Otsuka Initial or Prolonged Agitation Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Over a 10 day Hostility period, Paranoia dosage was increased from 10mg to Prozac C Clozaril C Neurontin C Date:02/26/04ISR Number: 4305482-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12393070 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Abilify Tabs PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Dosage: 15mg BID Aricept C Taken at 6:00 22-Feb-2006 08:31 AM Page: 343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report p.m. Ativan C Taken at noon, 4:00 p.m. and hour of sleep Zoloft C Sinemet C Bristol-Myers Squibb Company Dosage: 50mg/200mg one tablet every 8 hours Date:02/26/04ISR Number: 4305483-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12394953 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Health Abilify Tabs 15 Mg PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL reduced dose to 3.75 mg/day Verapamil C Lisinopril C Clonazepam C Aciphex C Date:02/26/04ISR Number: 4305484-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12397063 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Decreased Health Abilify Tabs PS Otsuka Nipple Pain Professional Pharmaceutical Prescribed Overdose Company, Ltd. ORAL 30 mg initial, 45 mg "now". Also reported that("dose Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL 30 mg initial, 45 mg "now". Also reported that("dose Seroquel C at hs Benadryl C Date:02/26/04ISR Number: 4305485-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12405460 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Abilify PS Otsuka Dysphasia Professional Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Valium C Prozac C 22-Feb-2006 08:31 AM Page: 344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305486-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411963 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Health Abilify Tabs 5 Mg PS Otsuka Swollen Tongue Professional Pharmaceutical Company, Ltd. ORAL Stopped on 18-Jul-2003, restarted on 20-Jul-2003 Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Stopped on 18-Jul-2003, restarted on 20-Jul-2003 Chlorpromazine C Oral or IM Diphenhydramine C 25 to 75 mg IM or oral every 4 hours as necessary Date:02/26/04ISR Number: 4305487-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12412342 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alcohol Use Health Abilify Tabs 15 Mg PS Otsuka Depression Professional Pharmaceutical Hallucination Company, Ltd. ORAL Tardive Dyskinesia Strattera C Lithium C Escitalopram C Trazodone Hcl C Apothecon Date:02/26/04ISR Number: 4305488-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12414645 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Hypersensitivity Health Abilify PS Otsuka Ear Infection Professional Pharmaceutical Feeling Hot Company, Ltd. ORAL 104 DAY Hypersensitivity Cephalosporin SS Urticaria Lamictal C Miralax C Date:02/26/04ISR Number: 4305489-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12415030 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Initially 5 mg/day, "quickly titrated up to 10 Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initially 5 22-Feb-2006 08:31 AM Page: 345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg/day, "quickly titrated up to 10 Trileptal C Adderall Xr C Gabitril C Date:02/26/04ISR Number: 4305490-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416624 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Abilify PS Otsuka Dystonia Professional Pharmaceutical Fear Company, Ltd. ORAL Neuroleptic Malignant Abilify SS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL Klonopin C Lithium C Quetiapine C Clonidine C Adderall C "2 forms" Date:02/26/04ISR Number: 4305491-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12417622 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Oculogyration Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305492-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420022 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Abilify PS Otsuka Initial or Prolonged Psychotic Disorder Professional Pharmaceutical Company, Ltd. ORAL Clozapine SS Risperdal C Zoloft C Date:02/26/04ISR Number: 4305493-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420626 Age:53 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Elavil C 25 mg hs Prozac C Xanax C 0.5 mg bid 22-Feb-2006 08:31 AM Page: 346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305494-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12424917 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify PS Otsuka Factitious Disorder Pharmaceutical Insomnia Company, Ltd. ORAL Initiated at Muscular Weakness 10 mg/day on Pain 25-Oct-2003, Restlessness increased to 20 mg/day on Metformin Hcl C Bristol-Myers Squibb Company Specific dosing not reported Actos C Hctz C Dosage form = 1/2 tablet Aspirin C Pravachol C Bristol-Myers Squibb Company Clonidine C Diltiazem Hcl C Apothecon Micardis C Zoloft C Date:02/26/04ISR Number: 4305495-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12425575 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL "once" Date:02/26/04ISR Number: 4305496-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12426482 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initially on 15 mg/day; increased to 20 mg/day; then back to Xanax C Date:02/26/04ISR Number: 4305497-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12426623 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Provigil SS ORAL Zoloft C Hydroxyzine C Clonazepam C 22-Feb-2006 08:31 AM Page: 347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305498-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12427217 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Wellbutrin C Date:02/26/04ISR Number: 4305499-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12427373 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify Tabs 30 Mg PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Depakote C Zyprexa C Date:02/26/04ISR Number: 4305500-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12428173 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breath Odour Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Astelin C Advair C Date:02/26/04ISR Number: 4305501-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12429106 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305502-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12429171 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify PS Otsuka Decreased Appetite Pharmaceutical Company, Ltd. ORAL Depakote C Folic Acid C Klonopin C Lamictal C Date:02/26/04ISR Number: 4305503-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12429254 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Overdose Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305504-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12429767 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Constipation Pharmaceutical Hypoglycaemia Company, Ltd. ORAL Insomnia Zyprexa C Pericolace C Paxil Cr C Date:02/26/04ISR Number: 4305505-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12429973 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Ritalin C Seroquel C Date:02/26/04ISR Number: 4305506-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12431441 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Palpitations Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Atenolol C Geneva Pharmaceuticals Technology, Corp. Lithium C Xanax C Seroquel C Calcium C Magnesium C Date:02/26/04ISR Number: 4305507-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12431847 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Muscle Rigidity Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305508-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432183 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Swelling Abilify PS Otsuka Swelling Face Pharmaceutical Company, Ltd. ORAL 5 WK Depakote C 22-Feb-2006 08:31 AM Page: 349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305509-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432191 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Tightness Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 1 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 DAY Effexor C Date:02/26/04ISR Number: 4305510-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432209 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alcohol Interaction Health Abilify PS Otsuka Sedation Professional Pharmaceutical Company, Ltd. 3 MON Alcohol I Date:02/26/04ISR Number: 4305511-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432415 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305512-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432423 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Geodon C Date:02/26/04ISR Number: 4305513-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432696 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Nausea Pharmaceutical Pain In Extremity Company, Ltd. ORAL Dose lowered Restlessness to 7.5 mg/day on 07-Oct-2003 Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose lowered to 7.5 mg/day on 07-Oct-2003 Imipramine C Paxil C 22-Feb-2006 08:31 AM Page: 350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305514-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12432712 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Abilify PS Otsuka Pharmaceutical Company, Ltd. Effexor C Date:02/26/04ISR Number: 4305515-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433223 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apathy Abilify PS Otsuka Depressed Mood Pharmaceutical Headache Company, Ltd. ORAL Remeron C Effexor C Neuroton C Lamictal C Lithium C Date:02/26/04ISR Number: 4305516-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433264 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C Date:02/26/04ISR Number: 4305517-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433397 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Abilify PS Otsuka Decreased Pharmaceutical Company, Ltd. Depakote C Zyprexa C Date:02/26/04ISR Number: 4305518-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433603 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305519-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433736 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305520-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433744 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5 mg Jul-03; increased to 30 mg Aug-03; D/C (no date) Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5 mg Jul-03; increased to 30 mg Aug-03; D/C (no date) Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5 mg Jul-03; increased to 30 mg Aug-03; D/C (no date) Celexa C Klonopin C Buspar C Bristol-Myers Squibb Company Date:02/26/04ISR Number: 4305521-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12433934 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 5 Mg PS Otsuka Fatigue Pharmaceutical Company, Ltd. ORAL Zonegran C Adderall C Date:02/26/04ISR Number: 4305522-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12434338 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305523-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12434569 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305524-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12434643 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Erectile Dysfunction Pharmaceutical Euphoric Mood Company, Ltd. ORAL 1 WK Insomnia Klonopin C Lotensin C Zyprexa C Dose decreased to 5 mg on 12-Nov-2003. Patient is Date:02/26/04ISR Number: 4305525-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12435228 Age:5 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradyphrenia Abilify PS Otsuka Hyperphagia Pharmaceutical Memory Impairment Company, Ltd. ORAL 10 WK Clonidine C Date:02/26/04ISR Number: 4305526-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12435301 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Hyperphagia Pharmaceutical Company, Ltd. ORAL "7.5 mg July - Aug 2003"; 7.5 mg 29-Oct-03 to 13-Nov-03. 2 WK Ativan C Neurontin C Seroquel C Lexapro C Antidepressant C Date:02/26/04ISR Number: 4305527-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12435392 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Staring Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage not taken on 13-Nov-2003, date of report. Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage not taken on 13-Nov-2003, date of report. 22-Feb-2006 08:31 AM Page: 353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Celexa C Risperdal C Benadryl C Albuterol Inhaler C Date:02/26/04ISR Number: 4305528-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12435780 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305529-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12435806 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Aciphex C Date:02/26/04ISR Number: 4305530-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12436150 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day, decreased to 10 mg/day, then 7.5 mg/day. Depakote C Propranolol C Date:02/26/04ISR Number: 4305531-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12436184 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305532-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12436408 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305533-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12436796 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Extrapyramidal Disorder Abilify PS Otsuka Parkinson'S Disease Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Topamax C Chloral Hydrate C 1 or 2 per day at hour of sleep Date:02/26/04ISR Number: 4305534-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12437653 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose reduced to 7.5 mg/day. Topamax C Date:02/26/04ISR Number: 4305535-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12437752 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify PS Otsuka Haematochezia Pharmaceutical Sleep Disorder Company, Ltd. ORAL Smoker Abilify SS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Depakote C Lasix C Potassium Supplement C Sonata C Lipitor C Date:02/26/04ISR Number: 4305536-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12437810 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical Company, Ltd. Topamax C Adderall Xr C Desyrel C Apothecon 22-Feb-2006 08:31 AM Page: 355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305537-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12438149 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Abilify PS Otsuka Hyponatraemia Pharmaceutical White Blood Cell Count Company, Ltd. Decreased Depakote C Zyprexa C Date:02/26/04ISR Number: 4305538-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12438545 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Tachycardia Pharmaceutical Company, Ltd. ORAL Initial dose: 5 mg/day Seroquel C Date:02/26/04ISR Number: 4305539-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12438594 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305540-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12439196 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Multivitamin C Vitamin C C Date:02/26/04ISR Number: 4305541-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12439261 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305542-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12440715 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify Tabs 15 Mg PS Otsuka Mania Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305543-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12440798 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305544-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12440830 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305545-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12440905 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305547-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12441242 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Risperdal C Date:02/26/04ISR Number: 4305548-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12441861 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305549-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12442034 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Started at 7.5 mg daily, increased to 15 mg daily, then 1 MON 22-Feb-2006 08:31 AM Page: 357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305550-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12442042 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Colitis Ulcerative Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Dose decreased to 5 mg daily and then discontinued. 6 WK Clonidine C QHS Date:02/26/04ISR Number: 4305551-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12442091 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Abilify PS Otsuka Hunger Pharmaceutical Hyperphagia Company, Ltd. 2 MON Weight Increased Clonidine C Trazodone Hcl Tabs C Apothecon Date:02/26/04ISR Number: 4305552-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12442315 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305553-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12442653 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Musculoskeletal Stiffness Pharmaceutical Tremor Company, Ltd. ORAL 20-Oct-2003: increased to 15 mg/day Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 20-Oct-2003: increased to 15 mg/day Seroquel C decreased to 600 mg/day Artane C Depakote C Keppra C Date:02/26/04ISR Number: 4305554-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12442984 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myoclonus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 22-Feb-2006 08:31 AM Page: 358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 5 mg (2 months ago), increased to 10 mg/day a Atenolol C Geneva Pharmaceuticals Technology, Corp. Reminyl C Date:02/26/04ISR Number: 4305555-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12443024 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305556-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12443438 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305557-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12443545 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Abilify PS Otsuka Initial or Prolonged Pulmonary Embolism Pharmaceutical Company, Ltd. ORAL 3 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Neurontin C Tegretol C Clonopin C Date:02/26/04ISR Number: 4305558-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12443693 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 10 mg tablet Depakote C Paxil C Buspar C Bristol-Myers Squibb Company Remeron C Seroquel C Accupril C Lopressor C 22-Feb-2006 08:31 AM Page: 359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nitroglycerin C Synthroid C Date:02/26/04ISR Number: 4305559-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12443735 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Ativan C 1 WK Zyprexa C 1 MON Date:02/26/04ISR Number: 4305560-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12443743 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305561-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12443768 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify PS Otsuka Antineutrophil Pharmaceutical Cytoplasmic Antibody Company, Ltd. Positive Crohn'S Disease Red Blood Cell Sedimentation Rate Increased Date:02/26/04ISR Number: 4305562-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12444402 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305563-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12444485 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305564-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12444493 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL "Possibly" initiated at 5 mg/day. Date:02/26/04ISR Number: 4305565-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12446290 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305566-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12447132 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Date:02/26/04ISR Number: 4305567-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12447199 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tremor Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 15mg for 2 weeks then switched to 15mg alternate 1 MON Depakote C Synthroid C Glucovance C Bristol-Myers Squibb Company Xanax C Advicor C Date:02/26/04ISR Number: 4305568-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12447587 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Catecholamines Abilify PS Otsuka Decreased Pharmaceutical Somnolence Company, Ltd. 22-Feb-2006 08:31 AM Page: 361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305569-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12447892 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Feeling Jittery Pharmaceutical Insomnia Company, Ltd. ORAL 1 WK Strattera C Trazodone Hcl C Apothecon Date:02/26/04ISR Number: 4305570-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12448262 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Wellbutrin C Clozaril C Lexapro C Date:02/26/04ISR Number: 4305571-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12448452 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Abuser Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305572-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12449278 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Otsuka Initial or Prolonged Fatigue Pharmaceutical Hallucination Company, Ltd. ORAL increased to Social Avoidant Behaviour 30 mg/day on Urinary Tract Infection 21-Nov-2003 Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL increased to 30 mg/day on 21-Nov-2003 Ativan C Date:02/26/04ISR Number: 4305573-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12449302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg for the past 2-3 months Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg for the 22-Feb-2006 08:31 AM Page: 362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report past 2-3 months Date:02/26/04ISR Number: 4305574-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12449310 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Fatigue Pharmaceutical Nausea Company, Ltd. ORAL Vomiting Altace C Nexium C Claritin C Date:02/26/04ISR Number: 4305575-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450003 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menstrual Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305576-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450714 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose: 5 mg/day; dose increased to 10 mg/day, Date:02/26/04ISR Number: 4305577-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450722 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg (date not reported) then 10 mg (date not reported) Date:02/26/04ISR Number: 4305578-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450730 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305579-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450763 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apathy Abilify PS Otsuka Somnolence Pharmaceutical Weight Increased Company, Ltd. ORAL Initiated at 5 mg/day; increased to 15 mg/day; decreased to Adderall C Lamictal C Date:02/26/04ISR Number: 4305580-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450813 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305581-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450839 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305582-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450870 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305583-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450938 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL part of a 15 mg tablet Levoxyl C Pravachol C Bristol-Myers Squibb Company Trazodone Hcl C Apothecon Date:02/26/04ISR Number: 4305584-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12450961 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify PS Otsuka Initial or Prolonged Stress Pharmaceutical 22-Feb-2006 08:31 AM Page: 364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305585-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12451282 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305586-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12451290 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Engorgement Abilify PS Otsuka Galactorrhoea Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305587-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12451464 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C Ativan C Date:02/26/04ISR Number: 4305588-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12451506 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305589-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12451696 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 10 mg/day in Apr-03. Restarted 24-Sep-03 at 5 mg/day. Olanzapine C Ziprasidone C 22-Feb-2006 08:31 AM Page: 365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305590-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12451894 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Abuser Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305591-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12451902 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Abuser Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305592-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12452082 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Abilify PS Otsuka Pruritus Pharmaceutical Vision Blurred Company, Ltd. ORAL Haldol C monthly injections Multivitamin C Date:02/26/04ISR Number: 4305593-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12452298 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify PS Otsuka Initial or Prolonged Hypothyroidism Pharmaceutical Other Company, Ltd. ORAL Initial dose: 15 mg/day Date:02/26/04ISR Number: 4305594-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12453460 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Sedation Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305595-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12453577 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Abilify Tabs 15 Mg PS Otsuka Hyperhidrosis Pharmaceutical Insomnia Company, Ltd. ORAL 1 DAY Vomiting Seroquel C 22-Feb-2006 08:31 AM Page: 366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305596-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454104 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 5 Mg PS Otsuka Headache Pharmaceutical Loss Of Consciousness Company, Ltd. ORAL One dose administered Lamictal C Trileptal C Date:02/26/04ISR Number: 4305597-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Antidepressant C Date:02/26/04ISR Number: 4305598-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454393 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305599-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454427 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Began dosing at 5 mg for 6 days then increased to 10 mg. Date:02/26/04ISR Number: 4305600-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454450 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305601-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454716 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Date:02/26/04ISR Number: 4305602-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454724 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305603-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454849 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305604-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454880 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs 10 Mg PS Otsuka Aspartate Pharmaceutical Aminotransferase Company, Ltd. ORAL Increased Abilify Tabs 10 Mg SS Otsuka Back Pain Pharmaceutical Blood Creatine Company, Ltd. ORAL Phosphokinase Increased Prozac C 20 mg two Eye Movement Disorder times every Headache day 2 YR Muscle Spasms Yasmin C Date:02/26/04ISR Number: 4305605-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456802 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Anxiety Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Food Craving Cozaar C Bristol-Myers Squibb Irritability Company Mood Altered Thyroid C Restlessness Date:02/26/04ISR Number: 4305606-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456851 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305607-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456869 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL Aminotransferase Depakote C Increased Risperdal C Blood Alkaline Benadryl C Phosphatase Increased Provera C Calcitriol C Keppra C Date:02/26/04ISR Number: 4305608-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456877 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Cold Abilify PS Otsuka Hypertension Pharmaceutical Company, Ltd. ORAL Methylphenidate C Prozac C Date:02/26/04ISR Number: 4305609-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456885 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 MON Depakote C Lithium C Date:02/26/04ISR Number: 4305610-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456919 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305611-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456927 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305612-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456976 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Akathisia Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305613-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12456992 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Akathisia Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305614-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457354 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Health Abilify PS Otsuka Dyskinesia Professional Pharmaceutical Eye Rolling Company, Ltd. ORAL Hallucination, Auditory Abilify SS Otsuka Mental Disorder Pharmaceutical Pregnancy Company, Ltd. ORAL Vomiting Prozac C Date:02/26/04ISR Number: 4305615-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457859 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Abilify PS Otsuka Nervousness Pharmaceutical Company, Ltd. ORAL Initial dose: 30 mg/day (for about 1 month) increased to 1 MON Cogentin C Synthroid C Singulair C Lipitor C Depakote C Advair Diskus C Date:02/26/04ISR Number: 4305616-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457867 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305617-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457917 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Bone Pain Pharmaceutical Sensation Of Heaviness Company, Ltd. ORAL 1 MON Tremor Imdur C Norvasc C Aspirin C 22-Feb-2006 08:31 AM Page: 370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305618-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457925 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Muscle Twitching Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL Initial dose: 2.5 mg/day for approx 1 week Date:02/26/04ISR Number: 4305619-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12458477 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cutaneous Lupus Abilify PS Otsuka Erythematosus Pharmaceutical Tremor Company, Ltd. ORAL Fish Oil C Cytomel C Imipramine C Aspirin C Diflucan C Allegra C Propranolol Hcl C Date:02/26/04ISR Number: 4305620-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12458550 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Abilify PS Otsuka Anorexia Pharmaceutical Anxiety Company, Ltd. ORAL Defaecation Urgency Acetaminophen C Diarrhoea Feeling Abnormal Insomnia Muscle Strain Photosensitivity Reaction Psychotic Disorder Weight Decreased Date:02/26/04ISR Number: 4305621-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12459178 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify Tabs 15 Mg PS Otsuka Hallucination Pharmaceutical Palpitations Company, Ltd. ORAL Psychotic Disorder Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Risperdal C ORAL 22-Feb-2006 08:31 AM Page: 371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305622-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460085 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Cogwheel Rigidity Pharmaceutical Dystonia Company, Ltd. ORAL Fall Abilify SS Otsuka Gait Disturbance Pharmaceutical Headache Company, Ltd. ORAL Tremor Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Prozac C Clonidine C Concerta C Date:02/26/04ISR Number: 4305623-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460127 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify PS Otsuka Drug Ineffective Pharmaceutical Company, Ltd. ORAL Prozac C Date:02/26/04ISR Number: 4305624-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460192 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305625-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460218 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 2.5 mg/day for 1 week Date:02/26/04ISR Number: 4305626-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460226 Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abnormal Behaviour Agitation Back Pain Hyponatraemia Nausea Polydipsia 22-Feb-2006 08:31 AM Page: 372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Haldol C Risperdal C 4 mg in am, and 8 mg at bedtime (for a long time). In Oct Neurontin C 800 mg in am, 16 mg at bedtime Synthroid C Vasotec C Hydrochlorothiazide C Diformin C Humulin Insulin C 35 u in am, 25 u in evening Antibiotic C Date:02/26/04ISR Number: 4305627-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460259 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305628-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460275 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305629-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460317 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:02/26/04ISR Number: 4305630-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460333 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL 15 mg/day beginning on 14-Dec-2003 22-Feb-2006 08:31 AM Page: 373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Allegra C Allegra-D C Klonopin C Xanax C Date:02/26/04ISR Number: 4305631-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460366 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305632-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460820 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Disorder Abilify PS Otsuka Insomnia Pharmaceutical Photophobia Company, Ltd. ORAL Stomach Discomfort Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Glyburide C Geneva Pharmaceuticals Technology, Corp. Actose C Date:02/26/04ISR Number: 4305633-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12460903 Age:3 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Abilify PS Otsuka Initial or Prolonged Nausea Pharmaceutical Suicidal Ideation Company, Ltd. ORAL Dose ranged from 10 mg/day to 30 mg/day. Lamictal C Mellaril C Quinine C Date:02/26/04ISR Number: 4305634-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12461182 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Rash Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305635-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12461216 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL reduced to 5 mg/day Date:02/26/04ISR Number: 4305636-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12461349 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Health Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Convulsion Professional Pharmaceutical Other Depressed Level Of Company, Ltd. ORAL 1/2 of a 10 Consciousness mg tablet Hypotension Abilify Tabs 10 Mg SS Otsuka Overdose Pharmaceutical Respiratory Depression Company, Ltd. ORAL 1/2 of a 10 Suicide Attempt mg tablet Tramadol SS ORAL Neurontin SS ORAL Date:02/26/04ISR Number: 4305638-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12461356 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Papular Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Date:02/26/04ISR Number: 4305639-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12461893 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305640-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12462545 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Date:02/26/04ISR Number: 4305641-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12462974 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305642-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12463485 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify PS Otsuka Drug Interaction Pharmaceutical Company, Ltd. ORAL Topamax I Date:02/26/04ISR Number: 4305643-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12463881 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chorea Abilify PS Otsuka Muscle Twitching Pharmaceutical Company, Ltd. Neurontin C Wellbutrin Sr C Lexapro C Date:02/26/04ISR Number: 4305644-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12463915 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lamictal C Date:02/26/04ISR Number: 4305645-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12464665 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Generalised Abilify PS Otsuka Urticaria Pharmaceutical Company, Ltd. ORAL 1 WK Date:02/26/04ISR Number: 4305646-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12464780 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305647-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12464905 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305648-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12465506 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305649-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12465605 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Colestid C Date:02/26/04ISR Number: 4305650-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466082 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305651-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466264 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Disturbance In Attention Pharmaceutical Company, Ltd. Zoloft C Date:02/26/04ISR Number: 4305652-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466454 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL one 10 mg tab once a day, then increased(dat e not Seroquel C reduced to 200 mg Strattera C Quinidine C Trileptal C Date:02/26/04ISR Number: 4305653-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466470 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 2 MON Date:02/26/04ISR Number: 4305654-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466504 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril C Buspar C Bristol-Myers Squibb Company Wellbutrin C Effexor C Ativan C Protonix C Diamox C Date:02/26/04ISR Number: 4305655-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466678 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphonia Abilify PS Otsuka Hair Growth Abnormal Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305656-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466819 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305657-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466827 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Agitation Pharmaceutical Insomnia Company, Ltd. ORAL 2 tablets Sleep Talking once daily at Sleep Walking bedtime Depakote C Wellbutrin C Klonopin C Date:02/26/04ISR Number: 4305658-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12467270 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. ORAL initial dose:15 mg/day 18-Mar-2003, 22-Feb-2006 08:31 AM Page: 378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report inc. to 20 9 MON Klonopin C Buspar C Bristol-Myers Squibb Company Date:02/26/04ISR Number: 4305659-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12467411 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Topamax I Date:02/26/04ISR Number: 4305660-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12468799 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Sedation Pharmaceutical Company, Ltd. ORAL Increased to 10 mg/day on 22-Dec-2003 Lithobid C Nortriptyline C Lexapro C Wellbutrin C Topamax C Date:02/26/04ISR Number: 4305661-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12469722 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Abilify PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Initiated on 26-Dec-2003: 7.5 mg/day, increased to 15 mg/day Date:02/26/04ISR Number: 4305662-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472049 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305663-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472098 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Zyprexa C 22-Feb-2006 08:31 AM Page: 379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305664-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472155 Age:10 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305665-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472163 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg 22-Nov-03 to 22-Dec-03; then increased to Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg 22-Nov-03 to 22-Dec-03; then increased to Risperdal C Catapres C Date:02/26/04ISR Number: 4305666-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472262 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305667-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472270 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL Initial dose Pulmonary Embolism was 15 mg/day. Risperdal C Date:02/26/04ISR Number: 4305668-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305669-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472338 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Abilify PS Otsuka Initial or Prolonged Tremor Pharmaceutical Company, Ltd. ORAL dose increased to 20 mg about 1 month ago. Lithium C 450 mg in the morning; 675 mg in the evening Neurontin C Date:02/26/04ISR Number: 4305670-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472627 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Nausea Pharmaceutical Vomiting Company, Ltd. BUCCAL 30 mg q HS Metformin Hcl C Bristol-Myers Squibb Company Veramil C Aspirin C Glipizide C Ascorbic Acid C Date:02/26/04ISR Number: 4305671-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472676 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4305672-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472783 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305673-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472916 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4305674-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472924 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Stopped in Nov-2003; resumed in Dec-2003; discontinued Date:02/26/04ISR Number: 4305675-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472932 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose increased to 30 mg/day on 22-Dec-2003 Date:02/26/04ISR Number: 4305676-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472981 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/26/04ISR Number: 4305677-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/26/04ISR Number: 4307053-XReport Type:Direct Company Report #CTU 213298 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Aripiprazole Initial or Prolonged Muscle Contractions (Abilify(R)) PS ORAL 10 MG PO QHS 2 WK Involuntary Concerta C Muscle Rigidity Catapres C Tongue Disorder Depakote C Tremor Date:02/27/04ISR Number: 4306755-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498036 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Abilify PS Otsuka Head Banging Professional Pharmaceutical Hypoventilation Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Trileptal C Taken for "years" - dose ranged from 150-750 mg BID Risperdal C Titrating down; daily dose at time of death was 2-3mg daily Contraceptive C Multivitamin C Date:03/01/04ISR Number: 4308334-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330429 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hyponatraemia Professional Pharmaceutical Renal Failure Acute Company, Ltd. ORAL Rhabdomyolysis Abilify Tabs 15 Mg I Otsuka Serotonin Syndrome Pharmaceutical Vomiting Company, Ltd. ORAL Effexor I At bedtime Risperdal I Topamax I Zonegran I Date:03/01/04ISR Number: 4308364-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12510327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Abilify PS Otsuka Initial or Prolonged Renal Failure Pharmaceutical Company, Ltd. ORAL one dose taken 1 DAY Seroquel C Zyprexa C Date:03/01/04ISR Number: 4308512-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12287546 Age:21 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acidosis Initial or Prolonged Alanine Aminotransferase Other Increased Aspartate Aminotransferase Increased Atrial Fibrillation Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Pressure Decreased Body Temperature 22-Feb-2006 08:31 AM Page: 383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Body Temperature Increased Bradycardia Report Source Product Role Manufacturer Route Dose Duration Cardiotoxicity Health Abilify Tabs 15 Mg PS Otsuka Coma Professional Pharmaceutical Electrocardiogram Qrs Company, Ltd. ORAL Complex Prolonged Abilify Tabs 15 Mg SS Otsuka Electrocardiogram Qt Pharmaceutical Prolonged Company, Ltd. ORAL Heart Rate Decreased Abilify Tabs 15 Mg SS Otsuka Heart Rate Increased Pharmaceutical Hypotension Company, Ltd. ORAL Intentional Overdose Abilify Tabs 15 Mg SS Otsuka Overdose Pharmaceutical Pneumonia Aspiration Company, Ltd. ORAL Respiratory Arrest Effexor SS Respiratory Rate Zantac C Decreased Lexapro C Respiratory Rate Increased Status Epilepticus Suicide Attempt Date:03/02/04ISR Number: 4309364-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12411815 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Altered Visual Depth Abilify PS Otsuka Initial or Prolonged Perception Pharmaceutical Other Bipolar Disorder Company, Ltd. ORAL Initial Disorientation dosage was Dizziness 7.5mg daily Drooling (19-Jun), Dysuria increased to Extrapyramidal Disorder Seroquel C On Hyperhidrosis 19-Jun-2003 Hypersensitivity dosage was Incoherent decreased to 100 mg daily Zyrtec C Ativan C Date:03/02/04ISR Number: 4309365-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12474573 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Self-Injurious Ideation Pharmaceutical Company, Ltd. ORAL 15 mg 05-Dec-03 to 05-Jan-04; then 30 mg 06-Jan-04 to Zopiclone C Sertraline C 22-Feb-2006 08:31 AM Page: 384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309863-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12472999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309864-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12473005 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309865-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12473211 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL reduced to 2.5 mg/day Date:03/03/04ISR Number: 4309866-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12473427 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 07-Jan-04 dose reduced to one piece of a 10 mg sample tablet Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 07-Jan-04 dose reduced to one piece of a 10 mg sample tablet Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 07-Jan-04 dose reduced to one piece of a 10 mg sample tablet Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 07-Jan-04 dose reduced to one piece of a 10 mg sample tablet Abilify SS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 07-Jan-04 dose reduced to one piece of a 10 mg sample tablet Depakote C Date:03/03/04ISR Number: 4309867-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12473583 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Blood Pressure Increased Pharmaceutical Company, Ltd. ORAL Dosing initiated at 2.8 mg on 26-Nov-2003; increased to Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dosing initiated at 2.8 mg on 26-Nov-2003; increased to Effexor Xr C Topamax C Metaxalone C Terazosin C Zantac C Serevent C Verapmil C Aciphex C Yasmin C Albuterol C Flovent C Spironolactone C Nystatin C Apothecon Diflucan C Date:03/03/04ISR Number: 4309868-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12473906 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309869-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12473922 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309870-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12474581 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309871-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12474847 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309872-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12474961 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309873-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12475497 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initial dose: 5 mg/day Concerta C Seroquel C Date:03/03/04ISR Number: 4309874-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12475612 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309875-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12476206 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Abilify PS Otsuka Pharmaceutical Company, Ltd. Adderall C Lithium C 22-Feb-2006 08:31 AM Page: 387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309876-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12476230 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:03/03/04ISR Number: 4309877-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12476834 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309878-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12476842 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309879-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12477048 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day started on 02-Dec, 10 mg/day from 04Dec-09Dec, Strattera C Zoloft C Date:03/03/04ISR Number: 4309880-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12478194 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify PS Otsuka Drooling Pharmaceutical Intentional Self-Injury Company, Ltd. ORAL Tremor Avonex C Weight Increased Date:03/03/04ISR Number: 4309881-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12478319 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify PS Otsuka Initial or Prolonged Coordination Abnormal Pharmaceutical Dystonia Company, Ltd. ORAL Lethargy Tremor 22-Feb-2006 08:31 AM Page: 388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309882-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12478327 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Topamax C Lexapro C Date:03/03/04ISR Number: 4309883-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12478608 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Zyprexa C Date:03/03/04ISR Number: 4309884-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12478616 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Methylphenidate C Strattera C Date:03/03/04ISR Number: 4309885-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309886-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479242 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Anxiety Pharmaceutical Feeling Jittery Company, Ltd. ORAL Restlessness Lexapro C Benadryl C 22-Feb-2006 08:31 AM Page: 389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309887-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479267 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Restlessness Pharmaceutical Weight Decreased Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309888-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479317 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309889-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479622 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309890-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479705 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL dose increased "some days 5 mg daily" Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL dose increased "some days 5 mg daily" Lorazepam C Wellbutrin C Levoxyl C Zantac C Oxycodone C Date:03/03/04ISR Number: 4309891-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12479747 Age:32 YR Gender:Male I/FU:I Outcome PT Abasia Asthenia 22-Feb-2006 08:31 AM Page: 390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Potassium Increased Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Eskalith C Lorazepam C Date:03/03/04ISR Number: 4309892-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12480174 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Hypotension Pharmaceutical Psychiatric Symptom Company, Ltd. ORAL 3 MON Clozaril C Date:03/03/04ISR Number: 4309893-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12480216 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309894-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12480455 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Abilify PS Otsuka Hot Flush Pharmaceutical Nausea Company, Ltd. ORAL 5 mg Aug-03; Night Sweats incr to 10 mg (no date); on 10-Dec-03 incr again to Risperdal C Date:03/03/04ISR Number: 4309895-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12480505 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Insomnia Pharmaceutical Irritability Company, Ltd. Started on 15mg "2 1/2 months ago" Increased to 25mg approx. 2 MON Risperdal C Dosage was increased to 7 mg daily Klonopin C Given in the evening Lithium C 22-Feb-2006 08:31 AM Page: 391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Navane C Date:03/03/04ISR Number: 4309896-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12480919 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Abilify PS Otsuka Initial or Prolonged Dizziness Postural Pharmaceutical Malaise Company, Ltd. ORAL Initiated in Vision Blurred Apr-2003, Weight Decreased increased to 30 mg/day in Nov-2003. Tegretol C Zoloft C Xanax C Buspar C Bristol-Myers Squibb Company Vicodin C Atarax C Date:03/03/04ISR Number: 4309897-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12481511 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Abilify PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Advair C Flovent C Prednisone C Singulair C Guaifenesin C Clarinex C Estradiol C Apothecon Medroxyprogesterone C Levoxyl C Neurontin C Soma C Furosemide C Potassium Chloride C Geneva Pharmaceuticals, Inc. (Novartis) Naproxen C Date:03/03/04ISR Number: 4309899-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12483228 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify PS Otsuka Paranoia Pharmaceutical Company, Ltd. ORAL Zyprexa C Lithium C 22-Feb-2006 08:31 AM Page: 392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Date:03/03/04ISR Number: 4309900-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12483335 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Asthenia Pharmaceutical Balance Disorder Company, Ltd. ORAL Disorientation Abilify SS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL Klonopin C Levoxyl C Depakote C Luvox C Date:03/03/04ISR Number: 4309901-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12484150 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Jaw Disorder Abilify PS Otsuka Speech Disorder Pharmaceutical Company, Ltd. ORAL Zaroxolyn C Effexor Xr C Date:03/03/04ISR Number: 4309902-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12484416 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Buspar C Bristol-Myers Squibb Company Ritalin C Date:03/03/04ISR Number: 4309903-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12485041 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 MON Effexor C Date:03/03/04ISR Number: 4309904-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12485546 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Penile Pain Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Levoxyl C Mysoline C Aspirin C Bextra C Risperidal C Pletal C Zonegran C Altace C Chlor-Trimeton C Pepcid C Date:03/03/04ISR Number: 4309905-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12485561 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Klonopin C Date:03/03/04ISR Number: 4309906-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12485843 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. No information was reported Date:03/03/04ISR Number: 4309907-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12485884 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Seroquel C Decreasing doses: gradually decreased from 200 mg Trileptal C Navane C Antibiotic C Date:03/03/04ISR Number: 4309908-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12485918 Age:20 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Abilify PS Otsuka Medication Error Pharmaceutical No Adverse Effect Company, Ltd. 22-Feb-2006 08:31 AM Page: 394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309909-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12486007 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C dose titrated down then discontinued Date:03/03/04ISR Number: 4309910-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12486635 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309911-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12486916 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grimacing Abilify PS Otsuka Initial or Prolonged Muscle Tightness Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309912-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12487062 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Other Company, Ltd. ORAL Date:03/03/04ISR Number: 4309913-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12487997 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309914-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488359 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Abilify PS Otsuka Heart Rate Increased Pharmaceutical Company, Ltd. ORAL Geodon C 22-Feb-2006 08:31 AM Page: 395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309915-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488375 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Wellbutrin C Date:03/03/04ISR Number: 4309916-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488425 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309917-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488920 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309918-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488953 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309919-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12489548 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Abilify PS Otsuka Initial or Prolonged Attack Pharmaceutical Company, Ltd. ORAL Effexor Xr C Klonopin C Coumadin C Bristol-Myers Squibb Company Date:03/03/04ISR Number: 4309920-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12489563 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309921-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12490207 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Abilify Tabs 20 Mg PS Otsuka Emotional Disorder Pharmaceutical Paranoia Company, Ltd. ORAL Increased to Prescribed Overdose 40 mg/day on Self Esteem Decreased 12-Jan-2004. Social Avoidant Behaviour Effexor Xr C Zetia C Testosterone C Oxycontin C Oxyfast C Date:03/03/04ISR Number: 4309922-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12490223 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309923-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491023 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Dystonia Pharmaceutical Company, Ltd. ORAL Lithium C Date:03/03/04ISR Number: 4309924-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491148 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Lantus C Date:03/03/04ISR Number: 4309925-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491163 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309927-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491262 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Abilify PS Otsuka Congestive Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309928-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491452 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4309930-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491494 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Tightness Abilify PS Otsuka Swollen Tongue Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309931-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491759 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Date:03/03/04ISR Number: 4309932-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491858 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL 6 MON Digoxin C Amantadine I ORAL Date:03/03/04ISR Number: 4309933-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12492369 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Abilify PS Otsuka Pain Pharmaceutical Company, Ltd. 2 WK Abilify SS Otsuka Pharmaceutical Company, Ltd. 2 WK Date:03/03/04ISR Number: 4309934-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12492385 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4309935-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12492625 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309936-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12492948 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4309937-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12492997 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose 5 mg/day, titrated to 15 mg/day, decreased to Date:03/03/04ISR Number: 4309938-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12493029 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose 5 mg/day increased to 20 mg/day, decreased to Date:03/03/04ISR Number: 4309939-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12493748 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ageusia Abilify PS Otsuka Hypoaesthesia Oral Pharmaceutical Company, Ltd. ORAL Date:03/03/04ISR Number: 4310340-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494852 Age:2 YR Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Overdose Initial or Prolonged Depressed Level Of Other Consciousness Lethargy Medication Error 22-Feb-2006 08:31 AM Page: 399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Rate Increased Tremor Report Source Product Role Manufacturer Route Dose Duration Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. Date:03/03/04ISR Number: 4310341-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12497236 Age:2 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Abilify PS Otsuka Initial or Prolonged Accidental Overdose Professional Pharmaceutical Other Depressed Level Of Company, Ltd. Consciousness Lethargy Medication Error Respiratory Rate Increased Tremor Date:03/03/04ISR Number: 4310343-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12513362 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Abilify PS Otsuka Rash Maculo-Papular Pharmaceutical Company, Ltd. Date:03/04/04ISR Number: 4313843-XReport Type:Periodic Company Report #2003041739 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Health Geodon (Ziprasidone) PS ORAL 120 MG Corneal Reflex Decreased Professional (DAILY) ORAL Grimacing Company Lorazepam Photophobia Representative (Lorazepam) SS UNKNOWN UNKNOWN (UNKNOWN), UNKNOWN Aripiprazole (Aripiprazole) SS ORAL 15 MG (BID), ORAL Venlafaxine Hydrochloride C Paroxetine Hydrochloride C Alprazolam C Risperidone C Date:03/05/04ISR Number: 4312134-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12517579 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Weight Decreased Pharmaceutical Company, Ltd. ORAL Clozapine C prior to 22-Feb-2006 08:31 AM Page: 400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report starting aripiprazole Date:03/05/04ISR Number: 4312475-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12515821 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Abilify PS Otsuka Hospitalization - Diabetic Ketoacidosis Pharmaceutical Initial or Prolonged Drug Interaction Company, Ltd. ORAL Started Other Multi-Organ Failure dosing about Muscle Fatigue 3 months ago Pancreatitis Necrotising Xanax C in AM for Sepsis years Seroquel C 2 WK Serzone I Bristol-Myers Squibb Company 3 DAY Depakote I 3 MON Date:03/08/04ISR Number: 4313211-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12518593 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Date:03/09/04ISR Number: 4314225-7Report Type:Direct Company Report #CTU 214107 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Aripiprazole 15 Mg Initial or Prolonged Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 15 MG DAILY ORAL Date:03/10/04ISR Number: 4315162-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12515821 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Abilify PS Otsuka Hospitalization - Cardiac Failure Pharmaceutical Initial or Prolonged Cardiogenic Shock Company, Ltd. ORAL Started Other Diabetic Ketoacidosis dosing about Drug Interaction 3 months ago Fatigue Xanax C in AM for Hypovolaemic Shock years Multi-Organ Failure Seroquel C 2 WK Muscle Fatigue Serzone I Bristol-Myers Squibb Pancreatitis Necrotising Company 3 DAY Renal Failure Depakote I 3 MON Sepsis 22-Feb-2006 08:31 AM Page: 401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/04ISR Number: 4315576-2Report Type:Direct Company Report #CTU 214202E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Ariprazole PS ORAL 10 MG PO QD Initial or Prolonged Dysphagia Divalproex C Hypertonia Temazepam C Musculoskeletal Stiffness Lorazepam C Pantoprazole C Date:03/11/04ISR Number: 4315960-7Report Type:Direct Company Report #CTU 214309 E Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bipolar Disorder Abilify 30 Mg PS ORAL 30 MGX/PER Required Constipation DAY ORALLY Intervention to Schizoaffective Disorder 047 Prevent Permanent Zoloft C Impairment/Damage Seroquel C Topamax C Prolixin C Date:03/17/04ISR Number: 4318035-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12525259 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Abilify PS Otsuka Physical Assault Pharmaceutical Company, Ltd. ORAL Tylenol C Date:03/18/04ISR Number: 4319072-8Report Type:Direct Company Report #CTU 214711 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify PS PILL FORM Initial or Prolonged Anxiety Confusional State Eating Disorder Insomnia Malnutrition Mania Movement Disorder Restlessness Date:03/18/04ISR Number: 4319106-0Report Type:Direct Company Report #CTU 214661 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Aripiprazole PS ORAL ORAL Dystonia Speech Disorder 22-Feb-2006 08:31 AM Page: 402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/04ISR Number: 4319505-7Report Type:Direct Company Report #CTU 214758 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Abilify PS ORAL 15 MG PO BID Blood Creatine Duragesic Patch C Phosphokinase Increased Neurontin C Chest Pain Oxycontin C Depressed Level Of Lexapro C Consciousness Welchol C Drooling Estratest C Heart Rate Increased Flexeril C Mental Status Changes Quinine C Muscle Rigidity Fiber-Lax C Nausea Advair C Neuroleptic Malignant Fioricet C Syndrome Astelin C Overdose Vioxx C Screaming Albuterol C Vomiting Date:03/19/04ISR Number: 4320613-5Report Type:Direct Company Report #CTU 214827 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Bristol Grand Mal Convulsion Myers Squibb PS Bristol Myers Squibb ORAL 5 MG PO Q DAY Nausea [1ST DOSE] Tachycardia Zyprexa C Clonidine C Date:03/19/04ISR Number: 4322007-5Report Type:Expedited (15-DaCompany Report #2004-DE-01024GD(0) Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Literature Lithium Carbonate Initial or Prolonged Cogwheel Rigidity (Lithium Carbonate) PS 450 MG (IN Delusion DIVIDED Dysarthria DOSES) Gait Disturbance Clozapine Pleurothotonus (Clozapine) SS 150 MCG Therapy Non-Responder Aripiprazole Tremor (Aripiprazole) SS 15 MG Venlafaxine (Venlafaxine) C Date:03/19/04ISR Number: 4322169-XReport Type:Expedited (15-DaCompany Report #S04-USA-01085-01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Lexapro(Escitalopram Drug Ineffective ) PS Weight Increased Abilify /Usa/ (Aripiprazole) SS Abilify /Usa/Aripiprazole) SS Zyprexa (Olanzapine) C 22-Feb-2006 08:31 AM Page: 403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/04ISR Number: 4322008-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508529 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Abilify PS Otsuka Initial or Prolonged Dystonia Professional Pharmaceutical Company, Ltd. ORAL Date:03/23/04ISR Number: 4322010-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508636 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Abilify PS Otsuka Initial or Prolonged Dystonia Professional Pharmaceutical Company, Ltd. ORAL Date:03/23/04ISR Number: 4322012-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508628 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Abilify PS Otsuka Initial or Prolonged Dystonia Professional Pharmaceutical Company, Ltd. ORAL Date:03/24/04ISR Number: 4322483-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457354 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Spontaneous Abilify PS Otsuka Hospitalization - Blood Disorder Pharmaceutical Initial or Prolonged Cholecystectomy Company, Ltd. ORAL 9 MON Other Dehydration Abilify SS Otsuka Dyskinesia Pharmaceutical Eye Rolling Company, Ltd. ORAL 9 MON Hallucination, Auditory Prozac C Mental Disorder Pregnancy Procedural Complication Vomiting Date:03/25/04ISR Number: 4322990-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12474573 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Self-Injurious Ideation Pharmaceutical Company, Ltd. ORAL 15 mg 05-Dec-03 to 05-Jan-04; then 30 mg 06-Jan-04 to Zopiclone C Sertraline C Diazepam C 22-Feb-2006 08:31 AM Page: 404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/04ISR Number: 4323802-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12517470 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Olanzapine PS Face Oedema Lamictal C taken for several years Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Lithium I taken for several years Date:03/26/04ISR Number: 4324756-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12533188 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Ambien C Nicorette C Date:03/26/04ISR Number: 4324999-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498036 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Abilify PS Otsuka Head Banging Professional Pharmaceutical Injury Asphyxiation Company, Ltd. ORAL Initiated in Apr-2003 (7.5 mg/day), slowly titrated up Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated in Apr-2003 (7.5 mg/day), slowly titrated up Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated in Apr-2003 (7.5 mg/day), slowly titrated up Trileptal C Taken for "years" - dose ranged from 150-750 mg Risperdal C Dose in Dec-2003 increased from 2 to 3 mg/day Contraceptive C Multivitamin C 22-Feb-2006 08:31 AM Page: 405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/04ISR Number: 4332547-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040305774 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Risperdal Initial or Prolonged Paranoia Health (Risperidone) Psychotic Disorder Professional Tablets PS ORAL ORAL Suicide Attempt Aripiprazole Suspiciousness (Aripiprazole) SS ORAL 15 MG, 1 IN 1 Urinary Incontinence DAY, ORAL Vomiting Acetaminophen (Paracetamol) SS Date:03/31/04ISR Number: 4327785-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12499885 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Abilify PS Otsuka Exposure To Therapeutic Professional Pharmaceutical Drugs Company, Ltd. ORAL Epstein-Barr Virus Abilify SS Otsuka Infection Pharmaceutical Fatigue Company, Ltd. ORAL Pregnancy Zoloft C Date:04/01/04ISR Number: 4333180-7Report Type:Direct Company Report #CTU 213758 E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Abilify 5 Mg PS 5 GMQ AM Dehydration Zyprexa C Hallucination Depakote C Oral Intake Reduced Wellbutrin C Rhabdomyolysis Date:04/02/04ISR Number: 4330232-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12412078 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Drug Ineffective Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL 5 MON Suicidal Ideation Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 MON Buspar C Bristol-Myers Squibb Company Neurontin C Lexapro C Date:04/02/04ISR Number: 4330437-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494852 Age:2 YR Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Accidental Overdose Other Lethargy Medication Error 22-Feb-2006 08:31 AM Page: 406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Rate Increased Tremor Report Source Product Role Manufacturer Route Dose Duration Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. Date:04/02/04ISR Number: 4330602-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12497236 Age:2 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Abilify PS Otsuka Initial or Prolonged Depressed Level Of Professional Pharmaceutical Other Consciousness Company, Ltd. Lethargy Medication Error Munchausen'S Syndrome Respiratory Rate Increased Tremor Date:04/05/04ISR Number: 4331080-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539185 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mania Abilify PS Otsuka Other Sudden Cardiac Death Pharmaceutical Suicidal Ideation Company, Ltd. Initiated at 10 mg/day Lamictal C Varying doses Geodon C Date:04/05/04ISR Number: 4331531-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12513362 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Abilify PS Otsuka Initial or Prolonged Rash Maculo-Papular Pharmaceutical Other Company, Ltd. ORAL Focalin C Date:04/05/04ISR Number: 4332085-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12515821 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Abilify PS Otsuka Hospitalization - Diabetic Ketoacidosis Pharmaceutical Initial or Prolonged Drug Interaction Company, Ltd. ORAL Started Other Multi-Organ Failure dosing about Muscle Fatigue 3 months ago 4 MON Pancreatitis Necrotising Xanax C in AM for Sepsis years Seroquel C 2 WK Serzone I Bristol-Myers Squibb Company 3 DAY Depakote I ORAL 3 MON 22-Feb-2006 08:31 AM Page: 407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/04ISR Number: 4332939-XReport Type:Direct Company Report #CTU 215967 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify 15 Mg PS ORAL 15 MG PO Q Impaired Driving Ability HS Suicidal Ideation Neurontin C Eskalith Cr 450 Mg C Enalapril C Date:04/05/04ISR Number: 4332965-0Report Type:Direct Company Report #CTU 215970 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Aripiprazole 5 Mg Required Anxiety Bristol Meyers PS Bristol Meyers ORAL 5 MG X 1 Intervention to Difficulty In Walking DAILY ORAL IN Prevent Permanent Feeling Abnormal AM Impairment/Damage Flat Affect Xanax C Hallucination Prinivil C Insomnia Hctz C Nervous System Disorder Tremor Weight Decreased Date:04/06/04ISR Number: 4332731-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12464624 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Abilify PS Otsuka Other Infection Professional Pharmaceutical Company, Ltd. Date:04/07/04ISR Number: 4333815-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12543849 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify Tabs 5 Mg PS Otsuka Anorexia Pharmaceutical Blood Glucose Increased Company, Ltd. ORAL 3 WK Blood Pressure Increased Prinivil C Fluid Retention Hctz C Insomnia Lasix C Mania Xanax C Oedema Peripheral Date:04/07/04ISR Number: 4333816-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12533188 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Ambien C Nicorette C 22-Feb-2006 08:31 AM Page: 408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/04ISR Number: 4335170-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12517579 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Professional Pharmaceutical Weight Decreased Company, Ltd. ORAL after 4 weeks on drug, dose was increased to 30mg dates not provided. Clozapine C prior to starting aripiprazole. Dose withdrawn in Date:04/09/04ISR Number: 4335427-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12457354 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Spontaneous Health Abilify PS Otsuka Hospitalization - Acute Respiratory Professional Pharmaceutical Initial or Prolonged Distress Syndrome Company, Ltd. ORAL 9 MON Other Alanine Aminotransferase Abilify SS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL 9 MON Aminotransferase Prozac C Increased Zoloft C Aspiration Cholecystectomy Complications Of Maternal Exposure To Therapeutic Drugs Dehydration Dyskinesia Eye Rolling Hallucination, Auditory Maternal Drugs Affecting Foetus Mental Disorder Pregnancy Sepsis Vomiting Date:04/09/04ISR Number: 4335454-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12493342 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Abilify PS Otsuka Exposure To Therapeutic Pharmaceutical Drugs Company, Ltd. ORAL Intra-Uterine Death Seroquel SS 12.5 to 25 Maternal Drugs Affecting mg/day as Foetus needed Pregnancy Klonopin SS Lexapro SS Wellbutrin SS 22-Feb-2006 08:31 AM Page: 409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/04ISR Number: 4336785-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12548293 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Health Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Professional Pharmaceutical Company, Ltd. ORAL Date:04/13/04ISR Number: 4337491-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12549176 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Croup Infectious Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:04/21/04ISR Number: 4342791-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508636 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Abilify PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Date:04/21/04ISR Number: 4342795-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560181 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Was prescribed as: 5 mg q am x 4 days, then increase Date:04/21/04ISR Number: 4342796-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508529 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Abilify PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Date:04/21/04ISR Number: 4342801-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508628 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Abilify PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/04ISR Number: 4343071-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557872 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Abilify PS Otsuka Initial or Prolonged Insulin-Dependent Pharmaceutical Other Drug Interaction Company, Ltd. ORAL Initial dose Urinary Incontinence 5 mg/day, increased to 10 mg/day in Nov-2003, Tenex I 1 YR Date:04/21/04ISR Number: 4343074-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558664 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Diabetes Mellitus Pharmaceutical Insulin-Dependent Company, Ltd. ORAL Drug Ineffective Zyprexa C Nausea Zoloft C Urine Ketone Body Present Clonidine C Ddavp C Date:04/21/04ISR Number: 4343132-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12556486 Age:3 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Antidepressant Nos C Date:04/21/04ISR Number: 4343986-6Report Type:Direct Company Report #CTU 217081 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify 20 Mg Tab Bristol-Myers Squibb PS Bristol-Myers Squibb SEE #5 "DESCRIBE EVENT" Acetaminophen C Date:04/22/04ISR Number: 4344193-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557427 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceutical Mental Status Changes Company, Ltd. ORAL Motor Dysfunction Road Traffic Accident Suicidal Ideation Treatment Noncompliance Weight Decreased 22-Feb-2006 08:31 AM Page: 411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/04ISR Number: 4346321-2Report Type:Direct Company Report #CTU 217282 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Abilify 20 Mg Qd PS 20 MG Q HS Odynophagia Levoxyl C Prozac C Nortipyline C Date:04/23/04ISR Number: 4346333-9Report Type:Direct Company Report #CTU 217285 E Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Aripiprazole 10 Mg PS ORAL 10 MG PO Initial or Prolonged Syndrome DAILY 1 DAY Date:04/26/04ISR Number: 4346176-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560397 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autism Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Dehydration Pharmaceutical Dysphagia Company, Ltd. ORAL Muscle Rigidity Pyrexia Date:04/28/04ISR Number: 4349377-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561619 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Abilify PS Otsuka Hospitalization - Phosphokinase Increased Pharmaceutical Initial or Prolonged Blood Creatinine Company, Ltd. Increased Abilify SS Otsuka Blood Glucose Increased Pharmaceutical Blood Urine Company, Ltd. Dehydration Zyprexa C Loss Of Consciousness Depakote C Myoglobin Urine Present Wellbutrin Sr C Psychotic Disorder Rhabdomyolysis Treatment Noncompliance Urine Ketone Body Present Date:04/28/04ISR Number: 4349966-9Report Type:Direct Company Report #CTU 217623 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysuria Abilify 10 Mg PS 1/2 QHS Erection Increased Date:04/29/04ISR Number: 4350503-3Report Type:Direct Company Report #CTU 217665 E Age:19 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Agitation Aripiprazole 15 Mg - Bladder Candidiasis 1/2 Tab- Blood Creatine Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 15 MG - 1/2 Phosphokinase Increased TAB- QH ORAL Blood Pressure Systolic Aripiprazole 15 Mg - Increased 1 Tab- Bristol-Myers Catatonia Squibb SS Bristol-Myers Squibb ORAL 15 MG 1 TAB Coma QHS ORAL Dehydration Risperidone C Depressed Level Of Olanzapine C Consciousness Lithium C Drooling Eskalith C Dystonia Benztropine C Heart Rate Increased Metabolic Encephalopathy Muscle Rigidity Mydriasis Neuroleptic Malignant Syndrome Pneumonia Aspiration Pyrexia Respiratory Failure Respiratory Rate Increased Skin Warm Social Avoidant Behaviour Staring Tachycardia Urinary Incontinence White Blood Cell Count Increased Date:04/30/04ISR Number: 4350494-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12521001 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Dysphagia Pharmaceutical Lethargy Company, Ltd. ORAL Refusal Of Treatment By Abilify SS Otsuka Relative Pharmaceutical Sedation Company, Ltd. ORAL Urinary Tract Infection Dilantin C Synthroid C Sinemet C Bristol-Myers Squibb Company Accupril C Effexor C Insulin C Asa C Plavix C Regulatory Health Authority South Africa Pravachol C Bristol-Myers Squibb Company Protonix C Provigil C 22-Feb-2006 08:31 AM Page: 413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/04ISR Number: 4350497-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539185 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mania Abilify PS Otsuka Other Sudden Cardiac Death Pharmaceutical Suicidal Ideation Company, Ltd. ORAL Initiated at Treatment Noncompliance 10 mg/day Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day Lamictal C Varying doses Geodon C Date:04/30/04ISR Number: 4351209-7Report Type:Direct Company Report #CTU 217723E Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify Initial or Prolonged Extrapyramidal Disorder (Aripiprazole) 15 Mg Medication Error Pill # 1/2. Bristol-Myers PS Bristol-Myers ORAL 1 DOSE OF ~7.5 MG PO Date:04/30/04ISR Number: 4351403-5Report Type:Direct Company Report #CTU 217767E Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify 10 Mg Initial or Prolonged Phosphokinase Increased Bristol-Myers Squibb PS Bristol-Myers Squibb Hyperkalaemia Myoglobin Blood Increased Renal Failure Acute Transaminases Increased Date:05/03/04ISR Number: 4351430-8Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12568309 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/03/04ISR Number: 4351431-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566246 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hirsutism Abilify PS Otsuka Initial or Prolonged Muscle Hypertrophy Pharmaceutical Psychotic Disorder Company, Ltd. ORAL 3 YR Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 YR Oxcarbazepine C Clonazepam C 22-Feb-2006 08:31 AM Page: 414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/04ISR Number: 4351432-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12564977 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 15mg 29-Mar-04 to 05-Apr-04,inc r 30mg 06-Apr-04 to Venlafaxine Hcl C Panadol C Zopiclone C Date:05/03/04ISR Number: 4351818-5Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12570966 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Lorazepam C Atenolol C Geneva Pharmaceuticals Technology, Corp. Date:05/04/04ISR Number: 4352251-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568762 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Organ Failure Company, Ltd. Date:05/04/04ISR Number: 4353316-1Report Type:Direct Company Report #CTU 217895 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Abilify 10 Mg Bms PS Bms ORAL 10 MG DAILY Life-Threatening Syndrome ORAL Hospitalization - Pneumonia Geodon 20 Mg Pfizer SS Pfizer ORAL 20 MG Q12 H Initial or Prolonged Sepsis PRN ORAL Exelon C Haldol C Remeron C Zyprexa C Levaquin C Celexa C Motrin C Prevacid C Date:05/05/04ISR Number: 4353312-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571485 Age: Gender:Male I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:31 AM Page: 415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Completed Suicide Pharmaceutical Company, Ltd. ORAL Parnate C Seroquel C Corgard C Geneva Pharmaceuticals, Inc. (Novartis) Tegretol C Date:05/05/04ISR Number: 4354097-8Report Type:Direct Company Report #CTU 217993 Age:17.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify 5 Mg -> 1/2 Laceration Tab PS 1ST DOSE 1 MON Tongue Disorder Seroquel C Date:05/05/04ISR Number: 4354099-1Report Type:Direct Company Report #CTU 217996 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Ability 5 Mg PS 5 MG PM Dizziness Headache Vertigo Date:05/06/04ISR Number: 4354019-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12572533 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Abilify PS Otsuka Cyanosis Pharmaceutical Dysstasia Company, Ltd. ORAL 1 DAY Pallor Date:05/06/04ISR Number: 4354087-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12536199 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Blood Creatine Phosphokinase Increased Catatonia Depressed Mood Dysphagia Fall Headache Hypertension Hypertonia Hypokinesia Leukocytosis Neck Pain Pyrexia 22-Feb-2006 08:31 AM Page: 416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Divalproex Sodium C Temazepam C Lorazepam C Pantoprazole C Date:05/06/04ISR Number: 4354088-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571493 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Abilify PS Otsuka Thrombosis Pharmaceutical Company, Ltd. ORAL Date:05/06/04ISR Number: 4354563-5Report Type:Direct Company Report #CTU 218073 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify 15 Mg Bristol Myers Squibb PS Bristol Myers Squibb ORAL 15 MG QHS ORAL Topamax C Date:05/07/04ISR Number: 4356074-XReport Type:Direct Company Report #CTU 218180 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Aripiprazole PS Initial or Prolonged Blood Creatine Haloperidol Required Phosphokinase Increased Decanoate C Intervention to Confusional State Dantrolene C Prevent Permanent Dysphagia Clonidine C Impairment/Damage Labile Blood Pressure Lorazepam C Leukocytosis Acetaminophen C Muscle Rigidity Diphenhydramine C Pyrexia Benztropine C Tachycardia Clonazepam C Acetaminophen C Haloperidol C Hydrocortisone C Hydroxyzine C Temazepam C Risperidone C Nicotine Polacrilex C Trihexyphenidyl C Carbamazepine C Lorazepam C Magnesium Hydroxide C Haloperidol C Antacid Concentrate C Acetaminophen C Ranitidine C Magnesium Sulfate C 22-Feb-2006 08:31 AM Page: 417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mvi C Thiamine C Folic Acid C Date:05/10/04ISR Number: 4355536-9Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12572210 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Abilify PS Otsuka Hospitalization - Completed Suicide Pharmaceutical Initial or Prolonged Mania Company, Ltd. 5 DAY Other Obsessive Thoughts Quetiapine C Suicidal Ideation Luvox C Topiramate C Date:05/13/04ISR Number: 4357446-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571485 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Health Abilify PS Otsuka Hospitalization - Completed Suicide Professional Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Parnate C Seroquel C Corgard C Geneva Pharmaceuticals, Inc. (Novartis) Tegretol C Date:05/13/04ISR Number: 4357583-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12556486 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Health Abilify PS Otsuka Hypersensitivity Professional Pharmaceutical Tremor Company, Ltd. ORAL Effexor Xr C Seroquel C Date:05/14/04ISR Number: 4357933-4Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12578563 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Psychotic Disorder Abilify PS Otsuka Sleep Disorder Pharmaceutical Company, Ltd. ORAL Clozapine C step reduction from 100 mg to 0 mg (every week 22-Feb-2006 08:31 AM Page: 418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4358088-2Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12572210 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Abilify PS Otsuka Hospitalization - Completed Suicide Professional Pharmaceutical Initial or Prolonged Mania Company, Ltd. 5 DAY Other Obsessive Thoughts Quetiapine C Suicidal Ideation Luvox C Topiramate C Date:05/14/04ISR Number: 4358270-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495222 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Date:05/17/04ISR Number: 4358781-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560397 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autism Health Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Dehydration Professional Pharmaceutical Dysphagia Company, Ltd. ORAL Extrapyramidal Disorder Muscle Rigidity Pyrexia Date:05/17/04ISR Number: 4358814-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495974 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Abilify PS Otsuka Initial or Prolonged Hypothermia Professional Pharmaceutical Platelet Count Decreased Company, Ltd. ORAL 3 MON White Blood Cell Count Clonazepam C Decreased Date:05/17/04ISR Number: 4358843-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561619 Age:49 YR Gender:Female I/FU:F Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Blood Creatinine Increased Blood Glucose Increased Blood Urine Dehydration Heat Stroke Loss Of Consciousness Myoglobin Urine Present Psychotic Disorder Rhabdomyolysis Sinus Tachycardia Treatment Noncompliance 22-Feb-2006 08:31 AM Page: 419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urine Ketone Body Present Report Source Product Role Manufacturer Route Dose Duration Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Depakote C Wellbutrin Sr C Date:05/18/04ISR Number: 4359516-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557872 Age:10 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Abilify PS Otsuka Initial or Prolonged Insulin-Dependent Professional Pharmaceutical Other Drug Interaction Company, Ltd. ORAL Initiated 5 Urinary Incontinence mg/day Aug-03, inc to 10 mg/day in Jan-04, Tenex I Date:05/19/04ISR Number: 4360288-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571493 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deep Vein Thrombosis Health Abilify PS Otsuka Thrombosis Professional Pharmaceutical Company, Ltd. ORAL Lexapro C Lopressor C Dilantin C Lipitor C Lasix C Trazodone Hcl C Apothecon Advair Diskus C Date:05/24/04ISR Number: 4362816-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568762 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Abilify PS Otsuka Initial or Prolonged Compartment Syndrome Professional Pharmaceutical Hepatic Failure Company, Ltd. titrated up Neuroleptic Malignant to 30 mg (no Syndrome dates Renal Failure specified), Rhabdomyolysis then Effexor Xr C Sonata C qhs Klonopin C 22-Feb-2006 08:31 AM Page: 420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/04ISR Number: 4364238-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12533188 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertensive Heart Health Abilify PS Otsuka Disease Professional Pharmaceutical Schizophrenia Company, Ltd. Ambien C Nicorette C Date:05/25/04ISR Number: 4364728-4Report Type:Direct Company Report #CTU 219371 E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Abilify 20 Mg Bms PS Bms ORAL 20 MG QD ORAL Intervention to Blood Glucose Increased Lorazepam C Prevent Permanent Incoherent Ziprasidone C Impairment/Damage Clonazepam C Gabapentin C Paxil C Terazosin C Lithium Carbonate C Propranolol C Quetiapine Fumarate C Synthroid C Metformin C Date:05/26/04ISR Number: 4365459-7Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12572210 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Abilify PS Otsuka Hospitalization - Completed Suicide Pharmaceutical Initial or Prolonged Mania Company, Ltd. 5 DAY Other Obsessive Thoughts Seroquel C ORAL 300 mg - 200 Suicidal Ideation mg begun 2-3 years prior Luvox C ORAL after food medication began 2 years prior Topiramate C ORAL Date:05/26/04ISR Number: 4365719-XReport Type:Direct Company Report #CTU 219512 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myoclonus Aripiprazole PS Initial or Prolonged Date:05/27/04ISR Number: 4365889-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566246 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hirsutism Health Abilify PS Otsuka Initial or Prolonged Muscle Hypertrophy Professional Pharmaceutical Psychotic Disorder Company, Ltd. ORAL 3 YR Abilify SS Otsuka 22-Feb-2006 08:31 AM Page: 421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL 3 YR Trileptal C Klonopin C Zantac C Date:05/27/04ISR Number: 4365893-5Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12590170 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Aripiprazole PS Otsuka Weight Decreased Professional Pharmaceutical Company, Ltd. ORAL increased to 30 mg/day in Feb-2004 Clozapine C dose reduced Date:05/27/04ISR Number: 4365902-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12588893 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Otsuka Initial or Prolonged Failure To Thrive Pharmaceutical Neuroleptic Malignant Company, Ltd. Syndrome Weight Decreased Date:05/27/04ISR Number: 4366024-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12588455 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Aripiprazole PS Otsuka Drug Interaction Professional Pharmaceutical Paranoia Company, Ltd. ORAL Aripiprazole I Otsuka Pharmaceutical Company, Ltd. ORAL Haloperidol Decanoate I INTRAMUSCULAR Date:05/27/04ISR Number: 4366025-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591889 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Aripiprazole PS Otsuka Drug Interaction Professional Pharmaceutical Paranoia Company, Ltd. ORAL Olanzapine I Date:05/27/04ISR Number: 4366564-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12575437 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Water Intoxication Abilify PS Otsuka Disability Pharmaceutical Company, Ltd. ORAL 25 DAY Wellbutrin C 22-Feb-2006 08:31 AM Page: 422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Date:05/28/04ISR Number: 4367151-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12596813 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Abilify PS Otsuka Other Phosphokinase Increased Pharmaceutical Hepatorenal Failure Company, Ltd. Muscle Rigidity Date:06/02/04ISR Number: 4368038-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12586970 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Candidiasis Abilify Tabs 15 Mg PS Otsuka Hospitalization - Metabolic Encephalopathy Pharmaceutical Initial or Prolonged Neuroleptic Malignant Company, Ltd. ORAL 1/2 of a 15 Syndrome mg tablet Pneumonia Aspiration from Respiratory Failure 23-Mar-04 to 24-Mar-04; Risperidone C ORAL 2 YR Eskalith C ORAL 2 YR Benztropine C ORAL Date:06/03/04ISR Number: 4370134-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12564621 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370135-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12565560 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Date:06/03/04ISR Number: 4370136-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12565594 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysuria Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/day, reduced to 10 mg/day, and reduced on Prozac C Clozaril C 10 YR 22-Feb-2006 08:31 AM Page: 423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370137-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566568 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Drug Interaction Pharmaceutical Eye Movement Disorder Company, Ltd. ORAL 5 DAY Soliloquy Valium I Topamax I Clozaril I Lipitor I Inderal I Progesterone I Welchol I Date:06/03/04ISR Number: 4370138-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566675 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370139-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566717 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Feeling Abnormal Pharmaceutical Somnolence Company, Ltd. ORAL Initiated at Weight Increased 2.5 mg/day Date:06/03/04ISR Number: 4370140-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12567962 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Abilify PS Otsuka Parkinsonism Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370141-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12567988 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 2.5 mg/day increased to 5 mg/day 6 WK Abilify SS Otsuka Pharmaceutical Company, Ltd. 2.5 mg/day increased to 5 mg/day 6 WK Tenex C 22-Feb-2006 08:31 AM Page: 424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370142-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568002 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Jul-2003 dose unknown; increased to 15 mg (date not Zoloft C Date:06/03/04ISR Number: 4370143-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568010 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Trismus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370144-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568028 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 2.5 mg/day increased to 5 mg/day Prozac C Date:06/03/04ISR Number: 4370145-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568192 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Tightness Abilify PS Otsuka Initial or Prolonged Torticollis Pharmaceutical Company, Ltd. ORAL Ssri C Concerta C Date:06/03/04ISR Number: 4370146-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568242 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 5 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370147-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12568366 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify PS Otsuka Diarrhoea Pharmaceutical Insomnia Company, Ltd. ORAL Nervousness Lexapro C Somnolence Vomiting Date:06/03/04ISR Number: 4370148-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12569737 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2.5 mg in AM and 5 mg in PM Depakote C Seroquel C 200 mg and 400 mg Date:06/03/04ISR Number: 4370149-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570271 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intestinal Obstruction Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Effexor Xr C 1 YR Ativan C 1 YR Trifluoperazine C 1 YR Date:06/03/04ISR Number: 4370150-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570370 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anticonvulsant Drug Level Abilify PS Otsuka Increased Pharmaceutical Drug Interaction Company, Ltd. Initial dose: Gait Disturbance 2.5 mg/day, Sedation inc to 5 Speech Disorder mg/day, then Treatment Noncompliance 10 mg/day, Depakote I Date:06/03/04ISR Number: 4370151-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570396 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anticonvulsant Drug Level Abilify PS Otsuka Decreased Pharmaceutical Drug Interaction Company, Ltd. Initial dose: 2.5 mg/day for one week. Depakote I 22-Feb-2006 08:31 AM Page: 426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370152-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570461 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Effexor C Xanax C Lomotil C Cozaar C Bristol-Myers Squibb Company Date:06/03/04ISR Number: 4370153-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570487 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370154-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570586 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Drug Interaction Pharmaceutical Company, Ltd. Exelon I Date:06/03/04ISR Number: 4370155-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570768 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370156-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571196 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Remeron C Cogentin C Date:06/03/04ISR Number: 4370157-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571238 Age:11 YR Gender:Female I/FU:I Outcome PT Abnormal Behaviour Gastrointestinal Disorder 22-Feb-2006 08:31 AM Page: 427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Started at 5 mg Aug-2003, increased to 10 mg, decreased to Date:06/03/04ISR Number: 4370158-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571295 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Aripiprazole PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL 1 DAY Date:06/03/04ISR Number: 4370159-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571469 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs 10 Mg PS Otsuka Dystonia Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370160-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573135 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370161-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573200 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Abilify PS Otsuka Initial or Prolonged Nausea Pharmaceutical Other Pneumonia Company, Ltd. ORAL taken for Vomiting "about" 1 week Insulin C dose varies Lithium C Date:06/03/04ISR Number: 4370162-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573390 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Pain Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose: 7.5 mg/day; restarted 1 22-Feb-2006 08:31 AM Page: 428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report year later at 2.5 mg/day Sertraline C Oxcarbazepine C Modafinil C Omega-3 C Bupropion C Date:06/03/04ISR Number: 4370163-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573424 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370164-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573440 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:06/03/04ISR Number: 4370166-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573945 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Hallucination, Auditory Pharmaceutical Insomnia Company, Ltd. ORAL Inc to 30 Ocular Hypertension mg/day; inc Prescribed Overdose to 40 mg/day; dec to 30 mg/day Effexor C Valium C Date:06/03/04ISR Number: 4370167-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573960 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Drug Toxicity Pharmaceutical Drug Withdrawal Syndrome Company, Ltd. Lorazepam I Diazepam I Date:06/03/04ISR Number: 4370168-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12576815 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Prozac C 22-Feb-2006 08:31 AM Page: 429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370169-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12576914 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370170-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12577714 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Zantac C Advil C Date:06/03/04ISR Number: 4370171-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12552972 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370172-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12553012 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370173-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12553038 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370174-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12553046 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370175-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12553236 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Abilify PS Otsuka Corrected Interval Pharmaceutical Prolonged Company, Ltd. Date:06/03/04ISR Number: 4370176-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12554143 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370177-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12554689 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL 10 mg then decreased to 5 mg/day; then decr. to 1/4 of a 5 mg Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg then decreased to 5 mg/day; then decr. to 1/4 of a 5 mg Melatonin C Concerta C Date:06/03/04ISR Number: 4370178-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12554820 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370179-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12555041 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Abilify PS Otsuka Medication Error Pharmaceutical No Adverse Effect Company, Ltd. ORAL Received 75 mg instead of 25 mg 1 DAY 22-Feb-2006 08:31 AM Page: 431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370180-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12555397 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activated Partial Abilify PS Otsuka Thromboplastin Time Pharmaceutical Shortened Company, Ltd. Prothrombin Level Contraceptive C Decreased Date:06/03/04ISR Number: 4370181-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12555678 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 DAY Date:06/03/04ISR Number: 4370182-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12555926 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370183-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12556395 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affect Lability Abilify PS Otsuka Chest Pain Pharmaceutical Delusion Company, Ltd. ORAL 11/03, 10 mg Discomfort w/ incr to 15 Feeling Abnormal or 20 mg; Hostility interrupted Memory Impairment 2/04; restart Treatment Noncompliance Prozac C Albuterol C Date:06/03/04ISR Number: 4370184-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12556478 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Eye Pain Pharmaceutical Hiccups Company, Ltd. ORAL Date:06/03/04ISR Number: 4370185-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12556783 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Date:06/03/04ISR Number: 4370186-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12556973 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370187-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557096 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370188-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 10 Mg PS Otsuka Tongue Disorder Pharmaceutical Company, Ltd. ORAL 1 WK Date:06/03/04ISR Number: 4370189-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557419 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paranoia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370190-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557443 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Date:06/03/04ISR Number: 4370191-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557468 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL 1 MON Aminotransferase Increased Blood Creatine Phosphokinase Increased 22-Feb-2006 08:31 AM Page: 433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370192-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12557682 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 YR Sonata C Date:06/03/04ISR Number: 4370193-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558243 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Walking Abilify PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370194-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558326 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370195-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558342 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Abilify PS Otsuka Initial or Prolonged Drug Interaction Pharmaceutical Company, Ltd. ORAL Either 5 or 10 mg/day Paxil I Date:06/03/04ISR Number: 4370196-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558623 Age:5 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 5 mg tab 3 WK Effexor C Zyprexa C Date:06/03/04ISR Number: 4370197-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558649 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Antidepressant C 22-Feb-2006 08:31 AM Page: 434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370198-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558672 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. dose increased to 45 mg/day on 12-Apr-04 (one 15 mg Date:06/03/04ISR Number: 4370199-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558680 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. on 12-Apr-04 dose increased to 60 mg daily (one 30 mg Date:06/03/04ISR Number: 4370200-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558714 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. One 15 mg tablet twice a day (total of 30 mg/day) Date:06/03/04ISR Number: 4370201-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558730 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 7.5 mg/day for 1 week, then increased to 3 WK Date:06/03/04ISR Number: 4370202-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12559241 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370203-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12559449 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify PS Otsuka Pharmaceutical Company, Ltd. Fluoxetine C Risperdal C Depakote C Date:06/03/04ISR Number: 4370204-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12559993 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 5 mg/day tab 30-Jan-04 and increased to 5 mg/day date Date:06/03/04ISR Number: 4370205-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560140 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Abilify PS Otsuka Initial or Prolonged Convulsion Pharmaceutical Syncope Company, Ltd. ORAL Neurontin C Date:06/03/04ISR Number: 4370206-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560173 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Abilify PS Otsuka Swollen Tongue Pharmaceutical Company, Ltd. ORAL Adderall C Zoloft C Date:06/03/04ISR Number: 4370207-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560215 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Abilify PS Otsuka Swollen Tongue Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370208-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560223 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. Dose was 22-Feb-2006 08:31 AM Page: 436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report reduced, value not provided. Risperidal C Dose was reduced then discontinued Lithium C Depakote C Date:06/03/04ISR Number: 4370209-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560249 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Eye Rolling Pharmaceutical Gait Disturbance Company, Ltd. Movement Disorder Abilify SS Otsuka Torticollis Pharmaceutical Company, Ltd. Depakote C Evry night:Q hs Buspar C Bristol-Myers Squibb Company Adderall C Date:06/03/04ISR Number: 4370210-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Abilify PS Otsuka Torticollis Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370211-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560561 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 10 Mg PS Otsuka Psychotic Disorder Pharmaceutical Rash Company, Ltd. ORAL Taken in Aug-2003 then stopped. Restarted around Date:06/03/04ISR Number: 4370212-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560942 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Abilify PS Otsuka Initial or Prolonged Vomiting Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370213-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560959 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antisocial Behaviour Abilify Tabs 10 Mg PS Otsuka Dyspnoea Pharmaceutical Nasal Congestion Company, Ltd. ORAL Somnolence Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C Date:06/03/04ISR Number: 4370214-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561320 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370215-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561353 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370216-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561361 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Feeling Hot Pharmaceutical Headache Company, Ltd. ORAL Insomnia Depakote C Celexa C Klonopin C Date:06/03/04ISR Number: 4370217-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561759 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL 3 WK Zyprexa C Trileptal C Prozac I Date:06/03/04ISR Number: 4370219-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561783 Age:12 YR Gender:Male I/FU:I Outcome PT Other Aggression Blood Alkaline Phosphatase Increased 22-Feb-2006 08:31 AM Page: 438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Mellitus Drug Ineffective Platelet Count Increased Report Source Product Role Manufacturer Route Dose Duration Staring Abilify PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Dosage varied from 5 mg/day to 15 mg/day. Concerta C 6 MON Clonidine C Being weaned; currently on 0.2-0.4 mg/day, but has been on Date:06/03/04ISR Number: 4370220-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12561874 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Effexor C Klonopin C Synthroid C Date:06/03/04ISR Number: 4370221-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12562104 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Neurontin C Femhrt C Date:06/03/04ISR Number: 4370222-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12562377 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unresponsive To Pain Abilify PS Otsuka Stimuli Pharmaceutical Company, Ltd. Beta-Blocker C 22-Feb-2006 08:31 AM Page: 439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370223-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12562401 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unresponsive To Pain Abilify PS Otsuka Stimuli Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370224-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12562427 Age:8 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unresponsive To Pain Abilify PS Otsuka Stimuli Pharmaceutical Company, Ltd. Initiated at 2.5 mg/day for 6-8 weeks, increased to Date:06/03/04ISR Number: 4370225-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12563854 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Auricular Swelling Abilify PS Otsuka Pneumonia Pharmaceutical Company, Ltd. ORAL 2 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Valproic Acid C Date:06/03/04ISR Number: 4370226-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12563987 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370227-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12564043 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Abilify Tabs 5 Mg PS Otsuka Increased Pharmaceutical Chest Pain Company, Ltd. 6 to 7 months 6 MON Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. 6 to 7 months 6 MON Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. 6 to 7 months 6 MON 22-Feb-2006 08:31 AM Page: 440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370228-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12564514 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Exfoliative Abilify Tabs 15 Mg PS Otsuka Erythema Pharmaceutical Exfoliative Rash Company, Ltd. ORAL Stopped on Schizophrenia 12-Apr-2004, restarted on 18-Apr-2004 Risperdal C Ativan C Dalmane C Cogentin C Date:06/03/04ISR Number: 4370229-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12564571 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370230-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12538229 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 dose taken 19-Mar-04, drug interrupted. Rechallenge Zantac C Verapmil C Effexor C Lamictal C Seroquel C Date:06/03/04ISR Number: 4370231-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12538492 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. ORAL Bactrim C Clindamycin C Date:06/03/04ISR Number: 4370232-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539193 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Sebulex Shampoo C 22-Feb-2006 08:31 AM Page: 441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370233-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539219 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 10 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL initially Klonopin C Claritin D C Lithium Carbonate C Date:06/03/04ISR Number: 4370234-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539235 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Prolixin Decanoate C Apothecon Date:06/03/04ISR Number: 4370235-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539763 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sinus Congestion Abilify PS Otsuka Sinus Headache Pharmaceutical Company, Ltd. ORAL Prevacid C Date:06/03/04ISR Number: 4370236-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370237-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539839 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370238-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12539979 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Acetaminophen C Celexa C Colace C Claritin C Tricor C 22-Feb-2006 08:31 AM Page: 442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370239-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12540019 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370240-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12540290 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Received 10 mg daily for several months - 1.5 months ago Adderall C Clonidine C Date:06/03/04ISR Number: 4370241-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12540779 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Effexor C Date:06/03/04ISR Number: 4370242-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12541645 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370243-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12542429 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 5 Mg PS Otsuka Depressed Mood Pharmaceutical Diarrhoea Company, Ltd. ORAL Dose Ear Pain increased to Flushing 7.5 mg daily Myalgia on 29-Mar-04. Pain Abilify Tabs 5 Mg SS Otsuka Pyrexia Pharmaceutical Rheumatoid Arthritis Company, Ltd. ORAL Dose Suicidal Ideation increased to 7.5 mg daily on 29-Mar-04. Effexor Xr C Neurontin C Klonopin C 22-Feb-2006 08:31 AM Page: 443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Remeron C Topamax C Corgard C Geneva Pharmaceuticals, Inc. (Novartis) Tylenol Extra Strength C Date:06/03/04ISR Number: 4370244-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12542437 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg tab 1/per day; d/c by pt; titrated to 22.5 mg/day; Cogentin C Seroquel C Date:06/03/04ISR Number: 4370245-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12542478 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphasia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Date:06/03/04ISR Number: 4370246-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12543054 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Adverse Event Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370247-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12543104 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 10 Mg PS Otsuka Nausea Pharmaceutical Vomiting Company, Ltd. ORAL Date:06/03/04ISR Number: 4370248-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12543658 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 MON Lamictal C Celexa C 22-Feb-2006 08:31 AM Page: 444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370249-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12544235 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Gait Disturbance Pharmaceutical Muscle Rigidity Company, Ltd. Vision Blurred Abilify SS Otsuka Pharmaceutical Company, Ltd. Zoloft C Date:06/03/04ISR Number: 4370250-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12544797 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Loss Poor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370251-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12544805 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify PS Otsuka Constipation Pharmaceutical Medication Error Company, Ltd. ORAL crushed in food Diltiazem Hcl Tabs C Apothecon Date:06/03/04ISR Number: 4370252-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12544904 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chromatopsia Abilify PS Otsuka Dizziness Pharmaceutical Tachycardia Company, Ltd. ORAL Visual Disturbance Topamax C Lamictal C Date:06/03/04ISR Number: 4370253-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12545000 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Additional lot #: 3C73YUD1A Date:06/03/04ISR Number: 4370254-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12545836 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370255-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12546016 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Strattera C Celexa C Wellbutrin C Date:06/03/04ISR Number: 4370256-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12546149 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flatulence Abilify Tabs 5 Mg PS Otsuka Stomach Discomfort Pharmaceutical Company, Ltd. ORAL Increased to 7.5 mg/day (1/2 of a 15 mg tablet) about 1 1/2 4 MON Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 7.5 mg/day (1/2 of a 15 mg tablet) about 1 1/2 4 MON Lexapro C Date:06/03/04ISR Number: 4370257-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12546792 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370258-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12546834 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Facial Palsy Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370259-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12547006 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Abnormal Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Olanzapine C 2 to 3 tablets at bedtime Topiramate C Date:06/03/04ISR Number: 4370260-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12547345 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370261-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12547402 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370262-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12547691 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 10 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370263-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12548418 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370264-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12548517 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day 6 WK 22-Feb-2006 08:31 AM Page: 447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370265-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12548533 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myoclonus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370266-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12548541 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day Date:06/03/04ISR Number: 4370267-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12549473 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Abilify Tabs 10 Mg PS Otsuka Increased Pharmaceutical Bradycardia Company, Ltd. 1/2 of a 10mg Cogwheel Rigidity tab 14 DAY Confusional State Convulsion Hostility Suicidal Ideation Tachycardia Vomiting Weight Decreased Date:06/03/04ISR Number: 4370268-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12549796 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370269-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12549820 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Abilify PS Otsuka Pharmaceutical Company, Ltd. Risperdal C Date:06/03/04ISR Number: 4370270-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12549846 Age:40 YR Gender:Male I/FU:I Outcome PT Alanine Aminotransferase Increased Cough 22-Feb-2006 08:31 AM Page: 448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Rhinitis Somnolence Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Varying doses; decreased to 5 mg/day after events Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Varying doses; decreased to 5 mg/day after events Benztropine C Risperdal C Clonazepam C Lithium C Prozac C Date:06/03/04ISR Number: 4370271-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550299 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370272-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550422 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370273-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370274-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550927 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370275-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550935 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Abilify PS Otsuka Initial or Prolonged Torticollis Pharmaceutical Company, Ltd. Initiated at 10 mg/day "several months" ago; increased to Date:06/03/04ISR Number: 4370276-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550943 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL started 5 mg then incr to 10 mg Date:06/03/04ISR Number: 4370277-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550950 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370279-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550968 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 8 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 8 DAY Tenormin C Diazid C Prevacid C Prinivil C Zyprexa C Xanax C Date:06/03/04ISR Number: 4370280-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12551008 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Abilify Tabs 15 Mg PS Otsuka Blood Glucose Increased Pharmaceutical Company, Ltd. ORAL 1 YR Insulin C Humalog C Klonopin C Glucophage C Bristol-Myers Squibb 22-Feb-2006 08:31 AM Page: 450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Glucotrol C Date:06/03/04ISR Number: 4370281-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12551214 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgeusia Abilify PS Otsuka Hallucination Pharmaceutical Headache Company, Ltd. ORAL Start dose Nausea 10mg, increased to 15mg, decreased on Navane C Date:06/03/04ISR Number: 4370282-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12551479 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify PS Otsuka Accidental Overdose Pharmaceutical Confusional State Company, Ltd. ORAL Prescribed Medication Error 5mg, 1 Somnolence tablet, p.o., twice daily 35 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Prescribed 5mg, 1 tablet, p.o., twice daily 35 DAY Date:06/03/04ISR Number: 4370283-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12551529 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose increased to 20 mg/day "a few weeks ago and Serzone SS Bristol-Myers Squibb Company Lexapro C Depakote C Gabitril C Klonopin C Date:06/03/04ISR Number: 4370284-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12551578 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Movement Disorder Abilify PS Otsuka Eye Pain Pharmaceutical Photophobia Company, Ltd. 4 MON 22-Feb-2006 08:31 AM Page: 451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS Otsuka Pharmaceutical Company, Ltd. 4 MON Date:06/03/04ISR Number: 4370285-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12551651 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify PS Otsuka Drooling Pharmaceutical Dysarthria Company, Ltd. ORAL 7.5 mg/day on Dyskinesia 25-Nov-03 for Gait Disturbance two weeks, Masked Facies then 15 mg/day Lexapro C Depakote C Flonase C Contraceptive C Date:06/03/04ISR Number: 4370286-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12552188 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370287-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12552881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Zonegran C Date:06/03/04ISR Number: 4370288-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12552899 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370289-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12523031 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370290-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12523056 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 9 MON Date:06/03/04ISR Number: 4370291-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12523213 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anhidrosis Abilify PS Otsuka Anxiety Pharmaceutical Back Injury Company, Ltd. ORAL Previously on Body Temperature 15 mg/day Increased from Dec-2002 Drug Effect Decreased to Feb-2003 Insomnia Date:06/03/04ISR Number: 4370292-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12523478 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370293-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524112 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Movement Disorder Pharmaceutical Company, Ltd. ORAL dose reduced to 10 mg/day, then 5 mg/day Date:06/03/04ISR Number: 4370294-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524161 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370295-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524203 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C 22-Feb-2006 08:31 AM Page: 453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370296-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524302 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Topamax C Date:06/03/04ISR Number: 4370297-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524617 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370298-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524666 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify PS Otsuka Initial or Prolonged Weight Increased Pharmaceutical Company, Ltd. ORAL Inc to 20 mg/day in Aug-03; dec to 2.5 mg/day in Nov-03; Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Inc to 20 mg/day in Aug-03; dec to 2.5 mg/day in Nov-03; Trileptal C 450 mg/morning; 525 mg/night Date:06/03/04ISR Number: 4370299-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524757 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Aggression Pharmaceutical Other Dystonia Company, Ltd. ORAL Extrapyramidal Disorder Prozac SS ORAL increased to Hallucination 20 mg/day in Irritability Jan-2004 Seroquel C ORAL Depakote C ORAL Increased to 1000 mg/day in Feb-2004 Zyprexa C 22-Feb-2006 08:31 AM Page: 454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370300-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12524799 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370301-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12525564 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonian Rest Tremor Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL reduced to 7.5 mg/day (1/2 tablet) on 19-Feb-2004. Wellbutrin Sr C Lexapro C Actos C Metformin Hcl C Bristol-Myers Squibb Company Diovan C Norvasc C Niacin C Zocor C Date:06/03/04ISR Number: 4370302-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12526117 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Abilify PS Otsuka Fatigue Pharmaceutical Medication Error Company, Ltd. ORAL Date:06/03/04ISR Number: 4370303-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12526133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Depakote C Concerta C Tenex C Seroquel C Zantac C Date:06/03/04ISR Number: 4370304-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12526166 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anhidrosis Abilify PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370305-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12526455 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Urinary Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 28-Mar-03 5mg, inc to 15 mg in Aug-03, inc to 30 mg in Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 28-Mar-03 5mg, inc to 15 mg in Aug-03, inc to 30 mg in Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 28-Mar-03 5mg, inc to 15 mg in Aug-03, inc to 30 mg in Zoloft C Date:06/03/04ISR Number: 4370306-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12526489 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C Lipitor C Os-Cal C Glucophage C Bristol-Myers Squibb Company Aspirin C Monopril C Bristol-Myers Squibb Company Date:06/03/04ISR Number: 4370307-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12526976 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Initiated 25-Jan-04 (2.5 mg/day), inc to 5 mg/day on Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 25-Jan-04 (2.5 mg/day), inc to 5 22-Feb-2006 08:31 AM Page: 456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg/day on Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 25-Jan-04 (2.5 mg/day), inc to 5 mg/day on Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 25-Jan-04 (2.5 mg/day), inc to 5 mg/day on Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 25-Jan-04 (2.5 mg/day), inc to 5 mg/day on Clonidine C Prozac C Claritin C Dose = 1 teaspoon Rhinocort C NASAL Dose = 1 spray each nostril Date:06/03/04ISR Number: 4370308-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12527594 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Abilify PS Otsuka Medication Error Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370309-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12527701 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Abilify PS Otsuka Psychomotor Hyperactivity Pharmaceutical Thinking Abnormal Company, Ltd. ORAL 10 mg/day up to 45 mg/day Seroquel C Ativan C 1 or 2 times/day Date:06/03/04ISR Number: 4370310-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12527966 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. pt on ability "since the beginning of 22-Feb-2006 08:31 AM Page: 457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 2003". Topamax C Effexor C Trazodone Hcl C Apothecon Two tablets daily and three tablets nightly Date:06/03/04ISR Number: 4370311-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12528139 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Toprol C Prinivil C Lasix C Minoxidil C Cardura C Depakote C Aspirin C Date:06/03/04ISR Number: 4370312-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12528501 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Cogentin C Zoloft C Date:06/03/04ISR Number: 4370313-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12529590 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370314-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12530465 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs 10 Mg PS Otsuka Depression Pharmaceutical Company, Ltd. ORAL Started dosing "7-9 days ago". Seroquel C Clonazepam C Depo-Provera C 22-Feb-2006 08:31 AM Page: 458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370315-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12530507 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370316-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12530721 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370317-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12530739 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil Cr C Date:06/03/04ISR Number: 4370318-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12531299 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370319-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12531505 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Skin Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370320-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12531547 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Date:06/03/04ISR Number: 4370321-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12531679 Age:16 YR Gender:Female I/FU:I Outcome PT Other Accidental Exposure Depression 22-Feb-2006 08:31 AM Page: 459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mania Medication Error Mydriasis Report Source Product Role Manufacturer Route Dose Duration Pallor Abilify PS Otsuka Stupor Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370322-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12531869 Age:3 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 8 MON Restoril C Date:06/03/04ISR Number: 4370323-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12531901 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Date:06/03/04ISR Number: 4370324-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12532214 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Date:06/03/04ISR Number: 4370325-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12532701 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370326-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12532958 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Reglan SS Paxil C Valium C Multivitamin C 22-Feb-2006 08:31 AM Page: 460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370327-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12534384 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370328-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12534707 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Dystonia Pharmaceutical Throat Tightness Company, Ltd. ORAL Decreased to 5 mg/day Concerta C Risperdal C Prozac C Ativan C Date:06/03/04ISR Number: 4370329-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12534764 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Convulsion Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C ORAL Currently being tapered off. Carbatrol C Lorazepam C Lasix C Date:06/03/04ISR Number: 4370330-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12534954 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gynaecomastia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370331-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12534996 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370332-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12535092 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify PS Otsuka Pharmaceutical Company, Ltd. slow taper Lamictal C Zyprexa C Klonopin C Date:06/03/04ISR Number: 4370333-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12535118 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oesophagitis Abilify Tabs 15 Mg PS Otsuka Panic Attack Pharmaceutical Pharyngitis Streptococcal Company, Ltd. ORAL Initiated 7.5 mg/day on 13-Jan-04, inc to 15 mg/day on Clonazepam C 1/2 of a 2 mg tablet in AM, one tablet at night Wellbutrin Sr C Lexapro C Zyprexa C Date:06/03/04ISR Number: 4370334-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12535597 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Otitis Media Abilify PS Otsuka Tachycardia Pharmaceutical Company, Ltd. ORAL dose was increased to 30 mg (date unknown) 2 MON Lexapro C Cipro C Xanax C Methotrexate C Bristol-Myers Squibb Company Ibuprofen C Date:06/03/04ISR Number: 4370335-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12536249 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Abilify PS Otsuka Other Grand Mal Convulsion Pharmaceutical Nausea Company, Ltd. ORAL Tachycardia Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C PRN Clonidine C prn 22-Feb-2006 08:31 AM Page: 462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metamucil C 1/2 Tablespoon in AM Tylenol C Date:06/03/04ISR Number: 4370336-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12536827 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Generalised Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370337-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12537072 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Mania Pharmaceutical Other Company, Ltd. ORAL Trazodone Hcl SS Apothecon Topamax C Klonopin C Lamictal C Date:06/03/04ISR Number: 4370338-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12537296 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370339-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12537502 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Personality Disorder Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370340-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12537510 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Company, Ltd. ORAL 3 MON Date:06/03/04ISR Number: 4370341-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12537536 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Formication Abilify PS Otsuka Weight Increased Pharmaceutical 22-Feb-2006 08:31 AM Page: 463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 3 MON Date:06/03/04ISR Number: 4370342-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12537981 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Otsuka Initial or Prolonged Pancreatitis Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Antidepressant C Date:06/03/04ISR Number: 4370343-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12538153 Age:2 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Abilify PS Otsuka Medication Error Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370344-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12522272 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370345-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12522934 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370346-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12506192 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 8 MON Date:06/03/04ISR Number: 4370347-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12506242 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370348-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12506259 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370349-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12506267 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370350-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12507182 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Dry Mouth Pharmaceutical Fatigue Company, Ltd. ORAL Insomnia Serzone SS Bristol-Myers Squibb Company ORAL Consumer started on 100 mg and graduated to 300 mer the Amarel C Zantac C Vicodin C Soma C Elavil C Baby Aspirin C Bacitracin Ointment C Date:06/03/04ISR Number: 4370351-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12507208 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370352-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508545 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. Wellbutrin C 22-Feb-2006 08:31 AM Page: 465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370353-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508552 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. Effexor C Date:06/03/04ISR Number: 4370354-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12508578 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370355-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509113 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Abilify PS Otsuka Abnormal Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zonegran C Date:06/03/04ISR Number: 4370356-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509121 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Irritable Bowel Syndrome Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370357-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509139 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor Xr C Klonopin C Date:06/03/04ISR Number: 4370358-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509154 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON 22-Feb-2006 08:31 AM Page: 466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metformin Hcl C Bristol-Myers Squibb Company Glucazide C Lisinopril C Nifedipine C Simvastatin C Geodon C Quetiapine C Date:06/03/04ISR Number: 4370359-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509295 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Xanax C Neurontin C Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370360-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509311 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370361-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509436 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370362-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12509808 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370363-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12510095 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Prozac C Date:06/03/04ISR Number: 4370364-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12510335 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Seroquel C 1 YR Date:06/03/04ISR Number: 4370365-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12510400 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370366-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12511044 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 MON Date:06/03/04ISR Number: 4370367-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12511051 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 MON Date:06/03/04ISR Number: 4370368-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12511069 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Date:06/03/04ISR Number: 4370369-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12511226 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Azmacort Inhaler C RESPIRATORY (INHALATION) 2 puffs twice daily Albuterol Inhaler C RESPIRATORY (INHALATION) 2 puffs every 6 hours as needed Ibuprofen C Date:06/03/04ISR Number: 4370370-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12511317 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370371-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12511622 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370372-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12511689 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Prescribed Overdose Pharmaceutical Thinking Abnormal Company, Ltd. ORAL incr, 20 mg Tremor (no date); incr, 45 mg (05-Aug-03);d ecr, 30 mg Trileptal C Vitamin E C Gabitril C Risperdal C Lithium C Depakote C Zyprexa C Lexapro C Navane C Date:06/03/04ISR Number: 4370373-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12513040 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370374-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12513073 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370375-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12513289 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C Date:06/03/04ISR Number: 4370376-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12513594 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 10 Mg PS Otsuka Hallucination Pharmaceutical Hypersomnia Company, Ltd. ORAL regimen from Salivary Hypersecretion 2.5 mg up to Verbal Abuse 10 mg starting in Jan-04. D/C'd Zantac C Baby Aspirin C Multivitamin C Hydrodiuril C Date:06/03/04ISR Number: 4370377-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12514592 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 DAY Clonazepam C Strattera C 50 mg in AM; 25 mg at night Tofranil C Zyrtec C Date:06/03/04ISR Number: 4370378-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12515342 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370379-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12515524 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Abilify PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. ORAL 15 mg/day from 18-Mar-03 to 27-May-03, then 1 YR Prozac C ORAL 90 mg tablets, two tablets/week Wellbutrin Sr C Vitamin E C Fosamax C Metamucil C Nasonex C Taken in fall and spring Date:06/03/04ISR Number: 4370380-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12515797 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day initiated March 2003; incr to 30 mg soon 1 YR Seroquel SS init 50 mg/day June 2003;100 mg/day(no date Mirtazapine C Clonazepam C Haloperidol C Date:06/03/04ISR Number: 4370381-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516001 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Insomnia Pharmaceutical Throat Tightness Company, Ltd. ORAL 2 WK Date:06/03/04ISR Number: 4370382-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516019 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370383-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516043 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Luvox C Date:06/03/04ISR Number: 4370384-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516076 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Antipsychotic C Date:06/03/04ISR Number: 4370385-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516100 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370386-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516126 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370387-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516571 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Zyprexa C Date:06/03/04ISR Number: 4370388-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516720 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370389-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12516746 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paranoia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:06/03/04ISR Number: 4370390-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12517694 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify PS Otsuka Hypersomnia Pharmaceutical Weight Increased Company, Ltd. ORAL Initial dose: 15 mg/day; decreased to 7.5 mg/day; increased to Date:06/03/04ISR Number: 4370391-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12517785 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Headache Pharmaceutical Company, Ltd. ORAL 7 DAY Prevacid C Navane C Date:06/03/04ISR Number: 4370392-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12518247 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370393-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12519864 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Muscle Rigidity Pharmaceutical Parkinsonian Gait Company, Ltd. ORAL 15 mg/day then dose reduced to 7.5 mg daily (date not Date:06/03/04ISR Number: 4370394-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12520433 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 15 mg AM; 10 mg PM 1 MON Ambien C Buspar C Bristol-Myers Squibb Company Zoloft C Heptaminol C Date:06/03/04ISR Number: 4370396-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12520714 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. Therapy stopped "about 18-Dec-2003". Geodon C Date:06/03/04ISR Number: 4370397-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12520771 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370398-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12520839 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Abilify PS Otsuka Heart Rate Increased Pharmaceutical Company, Ltd. ORAL 10 mg 18-Feb-04;inc reased to 20mg (date not Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg 18-Feb-04;inc reased to 20mg (date not Effexor C Seroquel C Lexapro C Date:06/03/04ISR Number: 4370399-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12521092 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370400-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12521605 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370401-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12521738 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Clonidine C Adderall C Date:06/03/04ISR Number: 4370402-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12522264 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Dysarthria Pharmaceutical Epistaxis Company, Ltd. ORAL Gait Disturbance Ativan C Mouth Haemorrhage Tremor Date:06/03/04ISR Number: 4370403-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12504270 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370404-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12506184 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify Tabs 10 Mg PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Effexor C Tetracycline C Date:06/03/04ISR Number: 4370405-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495925 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Fatigue Pharmaceutical Company, Ltd. 4 MON 22-Feb-2006 08:31 AM Page: 475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370406-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12496006 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370407-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12496246 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Abilify PS Otsuka Dizziness Pharmaceutical Fall Company, Ltd. ORAL 4 MON Nervousness Syncope Tremor Vision Blurred Date:06/03/04ISR Number: 4370408-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12496394 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370409-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12496451 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Muscle Rigidity Pharmaceutical Restlessness Company, Ltd. ORAL 2 DAY Tic Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 DAY Date:06/03/04ISR Number: 4370410-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12496469 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Abilify Tabs 10 Mg PS Otsuka Reading Disorder Pharmaceutical Somnolence Company, Ltd. ORAL dose decreased 2 WK Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL dose decreased 2 WK Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL dose decreased 2 WK Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL dose 22-Feb-2006 08:31 AM Page: 476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report decreased 2 WK Tenex C Edta C Amoxil C Date:06/03/04ISR Number: 4370411-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12496485 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370412-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12496519 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Neuroleptic Agent C Date:06/03/04ISR Number: 4370413-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12497301 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Date:06/03/04ISR Number: 4370414-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12497327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faecal Incontinence Abilify PS Otsuka Urinary Incontinence Pharmaceutical Company, Ltd. Zyprexa C Date:06/03/04ISR Number: 4370415-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12497368 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 MON Date:06/03/04ISR Number: 4370416-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12497715 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Acute Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose 15 mg/day from 22-Feb-2006 08:31 AM Page: 477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 03-Sep-2003 to 3 MON Dilantin C qhs; Taken for many years Calcium Carbonate C Ortho C TRANSDERMAL 3 WEEKS PER MONTH Seroquel C 300 mg/morning, 800 mg/evening Risperdal C Cogentin C 3 WK Pepcid C qhs Aciphex C Nasocort C NASAL 2 sprays qhs Lotrimin Cream C to toes qod Multivitamin C Sudafed C Mobic C Benztropine C Date:06/03/04ISR Number: 4370417-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498002 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370418-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498010 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Fall Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370419-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498044 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Syncope Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370420-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498291 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Motrin C 22-Feb-2006 08:31 AM Page: 478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370421-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498317 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Initiated on 07-Jan-04, 10 mg/day; increased to 45mg on Seroquel C Date:06/03/04ISR Number: 4370422-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498341 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Other Syndrome Company, Ltd. ORAL 2 DAY Seroquel SS Risperdal SS Effexor C Date:06/03/04ISR Number: 4370423-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498457 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370424-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498986 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370425-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12499612 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370426-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12500062 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Abilify PS Otsuka Increased Pharmaceutical Neuroleptic Malignant Company, Ltd. ORAL Syndrome Abilify SS Otsuka Tremor Pharmaceutical 22-Feb-2006 08:31 AM Page: 479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Clonidine C Depakote C Celexa C 40 mg/day reduced to 20 mg/day on 27-Jan-04 Date:06/03/04ISR Number: 4370427-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12500427 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphadenopathy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lamictal C Date:06/03/04ISR Number: 4370428-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12500443 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Nausea Pharmaceutical Vomiting Company, Ltd. 15 mg/day Dec-2003; 30 mg/day Jan-2004 but sometimes she Singulair C Paxil C Klonopin C Melatonin C Date:06/03/04ISR Number: 4370429-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12501060 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 10 mg/day initiated on 29-Jan-2004 Synthroid C Taken for a few years Asacol C 2 tablets three times daily for a few years Vistaril C Pepcid C Trazodone Hcl C Apothecon at bedtime Cogentin C Flexeril C at bedtime 22-Feb-2006 08:31 AM Page: 480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal C Luvox C at bedtime Date:06/03/04ISR Number: 4370430-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12501094 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Balance Disorder Pharmaceutical Blood Glucose Increased Company, Ltd. ORAL 2 WK Dizziness Glipizide C dose Pain In Extremity increased to 5 mg tablet 5 X/day (date not Date:06/03/04ISR Number: 4370431-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12501243 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose was either 10 or 15 mg/day Date:06/03/04ISR Number: 4370433-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12501292 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Adverse Event Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Reported as "possibly 5 mg" daily. Date:06/03/04ISR Number: 4370434-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12501318 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL 5mg 01Oct03x1 week,then 10mgx1 week,then 15mgx1 Zoloft C Date:06/03/04ISR Number: 4370435-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12501938 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose was 22-Feb-2006 08:31 AM Page: 481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report either 10 or 15 mg/day Date:06/03/04ISR Number: 4370436-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12502191 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370437-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12502258 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370438-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12502811 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Started 2.5 mg 00-Apr-2003 increased to 7.5 mg Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Started 2.5 mg 00-Apr-2003 increased to 7.5 mg Lamictal C Effexor Xr C Date:06/03/04ISR Number: 4370439-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12502878 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370440-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12502902 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370441-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12503298 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Trazodone Hcl C Apothecon 75-100 mg HS Strattera C Risperdal C Date:06/03/04ISR Number: 4370442-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12503348 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Abilify PS Otsuka Parkinsonism Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Clonazepam C Ativan C Antidepressant C Date:06/03/04ISR Number: 4370443-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12503371 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Date:06/03/04ISR Number: 4370444-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12503421 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anticonvulsant Drug Level Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370445-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12503439 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akinesia Abilify PS Otsuka Feeling Jittery Pharmaceutical Tremor Company, Ltd. ORAL Date:06/03/04ISR Number: 4370446-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12504031 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370447-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12212221 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Abnormal Behaviour Pharmaceutical Chest Pain Company, Ltd. ORAL taken Drug Ineffective Dec-2002 to Prescribed Overdose Jul-2003; Vomiting restarted 21-Feb-2004 Depakote C Date:06/03/04ISR Number: 4370448-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12311833 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Abilify Tabs 20 Mg PS Otsuka Lymphadenopathy Pharmaceutical Platelet Count Decreased Company, Ltd. ORAL Started on Pyrexia 5mg 04-24/dosage was increased/dru Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Started on 5mg 04-24/dosage was increased/dru Lamictal C Started on 25mg on 08-May/Increa sed to 50mg on Lithium C 300 mg qam/600 mg qhs Date:06/03/04ISR Number: 4370449-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376711 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370450-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12376737 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370451-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12459178 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify Tabs 15 Mg PS Otsuka Hallucination Pharmaceutical Palpitations Company, Ltd. ORAL Increased to Psychotic Disorder 22 mg/day, 30 mg/day, decreased to 15 mg/day Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 22 mg/day, 30 mg/day, decreased to 15 mg/day Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 22 mg/day, 30 mg/day, decreased to 15 mg/day Lexapro C Risperdal C ORAL Restarted at 1.5 mg one tablet per day. Zoloft C Date:06/03/04ISR Number: 4370452-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12463915 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5mg 12-Dec-2003 to 13-Dec-2003; incr. to Lamictal C Trileptal C Lorazepam C 1-2 MG Ambien C Date:06/03/04ISR Number: 4370453-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12466827 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Agitation Pharmaceutical Insomnia Company, Ltd. ORAL 2 tablets Oedema Peripheral once daily at Sleep Talking bedtime. Sleep Walking Decreased to Swelling Face 15 mg/day in Depakote C 22-Feb-2006 08:31 AM Page: 485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin C Klonopin C Date:06/03/04ISR Number: 4370454-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12478319 Age:21 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify PS Otsuka Initial or Prolonged Coordination Abnormal Pharmaceutical Dystonia Company, Ltd. ORAL "between 5-25 Lethargy mg" was Somnolence ingested Tremor Date:06/03/04ISR Number: 4370455-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12486916 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grimacing Abilify PS Otsuka Initial or Prolonged Muscle Tightness Pharmaceutical Company, Ltd. ORAL 5 DAY Adderall C 6 am and noon Depakote C Depakote XR @ 0600 and 1930 Clonidine C 0.05 mg @ 1600; 0.1 mg @ 0600, 1200, and 1930 Date:06/03/04ISR Number: 4370456-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488359 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Abilify PS Otsuka Initial or Prolonged Blood Pressure Increased Pharmaceutical Other Extrasystoles Company, Ltd. ORAL Geodon C ORAL taken for many months(no dose spec);10-Jan- MON Date:06/03/04ISR Number: 4370457-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12488953 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 7.5 mg/day; after one week increased to 15 mg/day; 3 WK Insulin C 22-Feb-2006 08:31 AM Page: 486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370458-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491262 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Abilify PS Otsuka Disability Congestive Pharmaceutical Other Company, Ltd. ORAL 5 MON Date:06/03/04ISR Number: 4370459-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491759 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL dose reduced on 29-Aug-03 to 10 mg/day (previous dose 10 mg Zoloft SS ORAL dose reduced (post event, no date reported) to 100 mg/day Gabitril C Provigil C Depakote C Dilantin C Clonazepam C Date:06/03/04ISR Number: 4370460-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12491858 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Stopped on 26-Jan-2004; 5 mg/day restarted on 09-Feb-2004 6 MON Digoxin C Calcium Carbonate C Amantadine I ORAL Date:06/03/04ISR Number: 4370461-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12493383 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify PS Otsuka Diarrhoea Pharmaceutical Erythema Company, Ltd. ORAL Gait Disturbance Abilify SS Otsuka Musculoskeletal Stiffness Pharmaceutical Tremor Company, Ltd. ORAL Klonopin C Lexapro C 22-Feb-2006 08:31 AM Page: 487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370462-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12493748 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ageusia Abilify Tabs 10 Mg PS Otsuka Glossodynia Pharmaceutical Hypoaesthesia Oral Company, Ltd. ORAL Increased to Swollen Tongue 10 mg (date not reported) Wellbutrin C Date:06/03/04ISR Number: 4370463-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494100 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370464-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494191 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Ambien C Clonazepam C 1 mg, one to two times daily Vitamin Supplement C Date:06/03/04ISR Number: 4370465-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494597 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370466-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494621 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370467-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12494670 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370468-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495321 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Risperdal C Date:06/03/04ISR Number: 4370469-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495370 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bloody Discharge Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/03/04ISR Number: 4370470-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495412 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL Seroquel C Date:06/03/04ISR Number: 4370471-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495552 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Insulin C Lexapro C Date:06/03/04ISR Number: 4370472-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495602 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370473-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495610 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4370474-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495677 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/03/04ISR Number: 4370475-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12495818 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Abilify PS Otsuka Psychomotor Hyperactivity Pharmaceutical Company, Ltd. ORAL 5 WK Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 WK Zocor C Prevacid C Trazodone Hcl Tabs 150 Mg C Apothecon Darvocet C Date:06/07/04ISR Number: 4371624-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12604492 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/08/04ISR Number: 4372837-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12598710 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:06/14/04ISR Number: 4376522-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12233607 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Aripiprazole PS Otsuka Initial or Prolonged Vertigo Professional Pharmaceutical Company, Ltd. ORAL Patient received only one dose. Quetiapine C Lorazepam C Temazepam C 22-Feb-2006 08:31 AM Page: 490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/04ISR Number: 4378234-4Report Type:Direct Company Report #CTU 220683 E Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Abilify PS 15 MG DAILY Initial or Prolonged Coma Zoloft SS Ventricular Extrasystoles Haldol C Date:06/15/04ISR Number: 4377391-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12572533 Age:6 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Abilify PS Otsuka Cyanosis Professional Pharmaceutical Dysstasia Company, Ltd. ORAL 1 DAY Pallor Date:06/17/04ISR Number: 4381400-5Report Type:Direct Company Report #CTU 220971 E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Abilify PS ORAL 10 MG PO QD Initial or Prolonged Decreased Morphine C Body Temperature Lotensin C Increased Colace C Drug Interaction Prozac C Neuroleptic Malignant Lasix C Syndrome Synthroid C Respiratory Rate Hyzaar C Increased Milk Of Magnesia C Coumadin C Tylenol C Date:06/17/04ISR Number: 4381424-8Report Type:Direct Company Report #CTU 220975 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify 15 Mg Daily Initial or Prolonged Acne Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 15MG DAILY Affective Disorder ORAL Blood Glucose Abnormal Lexapro 30 Mg Daily Condition Aggravated Forest Depression Pharmaceuticals SS Forest Hair Growth Abnormal Pharmaceuticals ORAL 30 MG DAILY Polycystic Ovaries ORAL Suicidal Ideation Thinking Abnormal Weight Increased Date:06/18/04ISR Number: 4380385-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12586970 Age:19 YR Gender:Male I/FU:F Outcome PT Life-Threatening Candidiasis Hospitalization - Metabolic Encephalopathy Initial or Prolonged Neuroleptic Malignant Syndrome Pneumonia Aspiration 22-Feb-2006 08:31 AM Page: 491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Health Abilify Tabs 15 Mg PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL 1/2 of a 15 mg tablet from 23-Mar-04 to 24-Mar-04; Risperidone C ORAL 2 YR Eskalith C ORAL 2 YR Benztropine C ORAL Date:06/21/04ISR Number: 4381248-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12615068 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Abilify PS Otsuka Delirium Pharmaceutical Hyperpyrexia Company, Ltd. ORAL Incontinence Date:06/21/04ISR Number: 4381254-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12575437 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Water Intoxication Health Abilify PS Otsuka Disability Professional Pharmaceutical Company, Ltd. ORAL 25 DAY Wellbutrin C Klonopin C at HS Date:06/21/04ISR Number: 4381255-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12609988 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Pseudocyst Abilify PS Otsuka Initial or Prolonged Pancreatitis Pharmaceutical Company, Ltd. ORAL 5 mg/day 12-Mar-04 and inc. to 10 mg/day on 23-Mar-04. Lamotrigine SS Seroquel C Reminyl C Effexor Xr C Nolvadex C Ambien C Melatonin C Xanax C Senokot C Remeron C 22-Feb-2006 08:31 AM Page: 492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/04ISR Number: 4383538-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12609988 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Pseudocyst Health Abilify PS Otsuka Initial or Prolonged Pancreatitis Professional Pharmaceutical Company, Ltd. ORAL 5 mg/day 12-Mar-04 and inc. to 10 mg/day on 23-Mar-04. Lamotrigine SS Seroquel C Reminyl C Effexor Xr C Nolvadex C Ambien C Melatonin C Xanax C Senokot C Remeron C Date:06/23/04ISR Number: 4383895-XReport Type:Direct Company Report #CTU 221252E Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS ORAL 30 MG PO QD Initial or Prolonged Bradycardia Ditropan Xl C Chest Discomfort Prilosec C Difficulty In Walking Risperdal C Trazodone C Zoloft C Restoril C Ultracet C Date:06/23/04ISR Number: 4383898-5Report Type:Direct Company Report #CTU 221255E Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Abilify PS ORAL 30 MG PO QD Initial or Prolonged Syncope Glucovance C Bumetanide C Kcl C Colace C Lexapro C Date:06/24/04ISR Number: 4385116-0Report Type:Direct Company Report #CTU 221438 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Aripiprazole 10 Mg PS ORAL 10 MG BID ORAL Carbidopa/Levodopa C Cephalexin C Entacapone C Rimatadine C Rivastigmine C Sertraline C 22-Feb-2006 08:31 AM Page: 493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/04ISR Number: 4384750-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12618252 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Lexapro C Date:06/25/04ISR Number: 4384984-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12604492 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Date:06/28/04ISR Number: 4385525-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12548293 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Date:06/28/04ISR Number: 4385526-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12615712 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Aripiprazole PS Otsuka Initial or Prolonged Depressive Symptom Professional Pharmaceutical Company, Ltd. ORAL Glyburide C Geneva Pharmaceuticals Technology, Corp. Ranitidine C Hydrocodone + Acetaminophen C 7.5/500 mg PRN Etodolac C Clotrimazole C TOPICAL Date:06/28/04ISR Number: 4386183-0Report Type:Direct Company Report #CTU 221655E Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Abilify PS ORAL 10 MG PO Initial or Prolonged Living Impaired DAILY Other Gait Disturbance Mirapex C Mobility Decreased Metopropolol C Simvastatin C Metformin C Sinemet 25/100cr C Synthroid C Hctz C Protonix C 22-Feb-2006 08:31 AM Page: 494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/04ISR Number: 4386184-2Report Type:Direct Company Report #CTU 221656E Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Activities Of Daily Abilify PS ORAL 5-10 MG DAILY Living Impaired PO Decreased Activity Paxil C Feeling Cold Requip C Gait Disturbance Sinemet C Anantadine C Prevacid C Water Pill C K + (Potassium) C Mvi C Date:06/28/04ISR Number: 4386254-9Report Type:Direct Company Report #CTU 221669 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conduction Disorder Abilify 10 Mg Po Electrocardiogram Pr Daily PS 10 MG DAILY Prolongation Zoloft C Date:06/28/04ISR Number: 4386876-5Report Type:Direct Company Report #CTU 221710 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Abilify 10 Mg Intervention to Pyrexia Squibb PS Squibb BY MOUTH 10 Prevent Permanent Vomiting MG AT BEDTIME Impairment/Damage Date:06/28/04ISR Number: 4389826-0Report Type:Expedited (15-DaCompany Report #2004040067 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchostenosis Consumer Neurontin Initial or Prolonged Gastrooesophageal Reflux (Gabapentin) PS ORAL 1800 MG (600 Other Disease MG, 3 IN 1 D) Odynophagia ,ORAL Suicidal Ideation Olanzapine (Olanzapine) SS ORAL ORAL Aripiprazole (Aripiprazole) SS ORAL ORAL Valproate Semisodium C Paroxetine Hydrochloride C Clonazepam C Diphenhydramine Hydrochloride C Date:06/29/04ISR Number: 4386305-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12618500 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Depakote C Date:06/29/04ISR Number: 4388094-3Report Type:Direct Company Report #CTU 221747 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Aripiprazole PS ORAL 30 MG DAILY ORAL Date:06/30/04ISR Number: 4414516-5Report Type:Periodic Company Report #2004029467 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Consumer Zoloft (Sertraline) PS ORAL (1 IN 1 D), Initial or Prolonged Drug Ineffective Health ORAL Other Hypothyroidism Professional Aripiprazole Somnolence (Aripiprazole) SS ORAL 10 (1 IN 1 Suicide Attempt D), ORAL Fexofenadine Hydrochloride (Fexofenadine Hydrochloride) C Fluticasone Propionate (Fluticasone Propionate) C Date:06/30/04ISR Number: 4415392-7Report Type:Periodic Company Report #2003038326 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Zoloft (Sertraline) PS ORAL 250 MG, ORAL Depressed Level Of Professional Aripiprazole Consciousness Company (Aripiprazole) SS ORAL 10 MG, ORAL Gait Disturbance Representative Midafinil Medication Error (Modafinil) C Overdose Valproate Semisodium Somnolence (Valproate Semisodium) C Tiagabine Hydrochloride (Tiagabine Hydrochloride) C Olanzapine (Olanzapine) C Lorazepam (Lorazepam) C Gabapentin (Gabapentin) C Phenytoin Sodium (Phenytoin Sodium) C 22-Feb-2006 08:31 AM Page: 496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/04ISR Number: 4390995-7Report Type:Direct Company Report #CTU 221983 Age:13 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Tightness Ability 10 Mg Otsuka PS Otsuka ORAL 10 MG PO QAM Depakote C Mvi W/Fe C Strattera C Benadryl C Vitamin E C Date:07/09/04ISR Number: 4393845-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12560181 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Rx written 08-Jul-04 - 10 mg qd 1 DAY Adderall Xr C Effexor Xr C tapered to d/c Date:07/13/04ISR Number: 4396855-XReport Type:Direct Company Report #CTU 222699 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Abilify 10 Mg PS 10 MG Hospitalization - Dysarthria Abilify 15 Mg SS 15 MG Initial or Prolonged Dysgraphia Disability Headache Hemiparesis Joint Stiffness Musculoskeletal Stiffness Neck Pain Date:07/14/04ISR Number: 4396721-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12630455 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Neonatal Disorder Abilify PS Otsuka Normal Newborn Pharmaceutical Prescribed Overdose Company, Ltd. ORAL Pruritus Twin Pregnancy Urinary Tract Infection Date:07/14/04ISR Number: 4397123-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12633269 Age:1 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Synostosis Abilify PS Otsuka Pharmaceutical Company, Ltd. TRANSPLACENTAL Atarax C TRANSPLACENTAL Benadryl C TRANSPLACENTAL Cefalexin C TRANSPLACENTAL Second 22-Feb-2006 08:31 AM Page: 497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report exposure in September of 2003. Dermacort C TRANSPLACENTAL Terbutaline C TRANSPLACENTAL Date:07/14/04ISR Number: 4397368-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12564977 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL 15mg 23-Mar-04 to 30-Mar-04, increased to 30mg Venlafaxine Hcl C Panadol C Zopiclone C Date:07/15/04ISR Number: 4404810-6Report Type:Expedited (15-DaCompany Report #2004040067 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Consumer Neurontin Initial or Prolonged Gastrooesophageal Reflux (Gabapentin) PS ORAL 1800 MG (600 Other Disease MG, 3 IN 1 Odynophagia D), ORAL Suicidal Ideation Olanzapine (Olanzapine) SS ORAL ORAL Aripiprazole (Aripiprazole) SS ORAL ORAL Valproate Semisodium C Paroxetine Hydrochloride C Clonazepam C Diphenhydramine Hydrochloride C Date:07/16/04ISR Number: 4399220-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12626081 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dry Skin Abilify PS Otsuka Erythema Pharmaceutical Face Oedema Company, Ltd. ORAL Flushing Pruritus Date:07/19/04ISR Number: 4400590-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12487039 Age:10 YR Gender:Female I/FU:F Outcome PT Other Acne Constipation Dyskinesia Fear 22-Feb-2006 08:31 AM Page: 498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glucose Tolerance Impaired Insulin Resistance Report Source Product Role Manufacturer Route Dose Duration Nightmare Abilify PS Otsuka Polycystic Ovaries Pharmaceutical Sleep Disorder Company, Ltd. ORAL Weight Increased Lexapro SS ORAL Date:07/19/04ISR Number: 4401508-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12633004 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify PS Otsuka Dyskinesia Pharmaceutical Muscle Twitching Company, Ltd. ORAL 10 mg Swollen Tongue 13-May-04, 20 mg 16-Jun-04, 30 mg 20-Jun-04, Wellbutrin Sr C in the morning Valtrex C Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg 13-May-04, 20 mg 16-Jun-04, 30 mg 20-Jun-04, Zoloft I Date:07/19/04ISR Number: 4401604-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12609988 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Pseudocyst Abilify PS Otsuka Initial or Prolonged Pancreatitis Pharmaceutical Company, Ltd. ORAL 5 mg/day 12-Mar-04 and inc. to 10 mg/day on 23-Mar-04;sto Lamotrigine SS Seroquel C Reminyl C Effexor Xr C Nolvadex C Ambien C Melatonin C Xanax C Senokot C Remeron C 22-Feb-2006 08:31 AM Page: 499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/04ISR Number: 4402769-9Report Type:Direct Company Report #CTU 223109E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hallucinations, Mixed Abilify 20 Mg Bms PS Bms ORAL 20 MG QAM Intervention to Illusion ORAL Prevent Permanent Mood Altered Bupropion C Impairment/Damage Self-Injurious Ideation Celexa C Visual Field Defect Zyprexa C Hctz C Ativan C Metoprolol C Mvi C Trazodone C Date:07/20/04ISR Number: 4402824-3Report Type:Direct Company Report #CTU 223092 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify PS 5 DAY Initial or Prolonged Tachycardia Concerta C Date:07/20/04ISR Number: 4402830-9Report Type:Direct Company Report #CTU 223098 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Balance Disorder Abilify 15 Mg PS ORAL 15 MG PO Q AM Dyspnoea Nuchal Rigidity Swollen Tongue Date:07/22/04ISR Number: 4404756-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12643490 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Victim Of Homicide Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:07/23/04ISR Number: 4405252-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12626974 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Abilify PS Otsuka Initial or Prolonged Aminotransferase Pharmaceutical Increased Company, Ltd. ORAL Blood Glucose Increased Lotensin C Deep Vein Thrombosis Colace C Depression Lasix C Drug Interaction Hyzaar C Hypertension Coumadin C Bristol-Myers Squibb Mental Status Changes Company Neuroleptic Malignant Tylenol C Syndrome Milk Of Magnesia C Tremor Synthroid C Prozac C Morphine I 22-Feb-2006 08:31 AM Page: 500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/04ISR Number: 4405253-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12643821 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epiglottic Oedema Abilify PS Otsuka Rash Pharmaceutical Rash Vesicular Company, Ltd. ORAL Date:07/23/04ISR Number: 4405256-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641056 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify PS Otsuka Hyperthermia Pharmaceutical Company, Ltd. Started at 15 mg/day on 16-Jun-03, inc to 20 mg/day in 5 MON Seroquel SS Dose increased from 600 mg to 800 mg/day on 11-Jun-04. Aciphex C Trazodone Hcl C Apothecon Lisinopril + Hctz C 10/12.5 mg Androgen C Dostinex C Date:07/23/04ISR Number: 4408693-XReport Type:Expedited (15-DaCompany Report #2004042258 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Zeldox (Capsules) Completed Suicide Company (Ziprasidone) PS ORAL 160 MG (2 IN Drug Ineffective Representative 1 D), ORAL Food Craving Risperidone Weight Increased (Risperidone) SS Aripiprazole(Aripipr azole) SS Isopromethazine Hydrochloride (Isopromethazine Hydrochloride) C Reboxetine (Reboxetine) C Date:07/30/04ISR Number: 4411710-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12645115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/04ISR Number: 4415634-8Report Type:Expedited (15-DaCompany Report #2004UW15662 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Seroquel PS ORAL 100 MG TID PO Decreased Appetite Professional Abilify SS Sleep Disorder Zyprexa SS Paxil SS Zantac SS Date:08/03/04ISR Number: 4413775-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12646345 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Decreased Abilify PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Phosphokinase Increased Company, Ltd. ORAL Decreased to Clonus 5 mg/day on Intentional Self-Injury 11-Jul-2004, Oedema Peripheral then Restlessness discontinued Stupor Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 5 mg/day on 11-Jul-2004, then discontinued Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 5 mg/day on 11-Jul-2004, then discontinued Prozac C Depakote C Date:08/03/04ISR Number: 4413908-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649042 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day on 15-Jul-04, inc to 10 mg/day on Paxil C Zyprexa C Xanax C Date:08/03/04ISR Number: 4413913-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648689 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tympanic Membrane Abilify PS Otsuka Perforation Pharmaceutical 22-Feb-2006 08:31 AM Page: 502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Symmetrel C Date:08/03/04ISR Number: 4414118-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12633269 Age:1 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Caesarean Section Health Abilify PS Otsuka Drug Exposure During Professional Pharmaceutical Pregnancy Company, Ltd. TRANSPLACENTAL Neonatal Disorder Synostosis Twin Pregnancy Date:08/03/04ISR Number: 4415950-XReport Type:Direct Company Report #CTU 224164 E Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Abilify PS Initial or Prolonged Decreased Activity Dehydration Dysarthria Dysphagia Ejection Fraction Decreased Paranoia Date:08/04/04ISR Number: 4414935-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12630455 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Health Abilify PS Otsuka Prescribed Overdose Professional Pharmaceutical Pruritus Company, Ltd. ORAL Twin Pregnancy Paxil C Urinary Tract Infection Date:08/04/04ISR Number: 4414945-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12626974 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Abilify PS Otsuka Initial or Prolonged Aspartate Professional Pharmaceutical Aminotransferase Company, Ltd. ORAL Increased Lotensin C Blood Creatine Colace C Phosphokinase Increased Lasix C Blood Glucose Increased Hyzaar C 50/12.5 per Deep Vein Thrombosis day Dehydration Coumadin C Bristol-Myers Squibb Depression Company Drug Interaction Tylenol C Hypertension Milk Of Magnesia C ORAL Metabolic Encephalopathy Synthroid C Renal Failure Prozac C Urinary Tract Infection Ms Contin I 22-Feb-2006 08:31 AM Page: 503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/04ISR Number: 4414950-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12651287 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day ended at 10 mg/day. Date:08/04/04ISR Number: 4414951-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649778 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day. Taken for 3 to 4 weeks. Date:08/04/04ISR Number: 4416187-0Report Type:Direct Company Report #CTU 224242E Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Initial or Prolonged Confusional State (Aripiprazole) PS Q DAILY Disorientation Mental Status Changes Date:08/04/04ISR Number: 4416256-5Report Type:Direct Company Report #CTU 224224E Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Aripiprazole PS 3 DAY Initial or Prolonged Confusional State Disorientation Date:08/05/04ISR Number: 4416006-2Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12631818 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Abilify PS Otsuka Dizziness Pharmaceutical Hypertension Company, Ltd. ORAL 2 DAY Loss Of Consciousness Tegretol C ORAL Syncope Lamictal C ORAL Thyroxine C ORAL Date:08/05/04ISR Number: 4416159-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12653333 Age:30 YR Gender:Female I/FU:I Outcome PT Other Alanine Aminotransferase Increased Aspartate 22-Feb-2006 08:31 AM Page: 504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Alkaline Phosphatase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Cholinergic Syndrome Company, Ltd. Extrapyramidal Disorder Diazepam C Leukocytosis Date:08/05/04ISR Number: 4416577-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12652228 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Professional Pharmaceutical Convulsion Company, Ltd. ORAL 14 DAY Hyponatraemia Cipramil C ORAL 10 mg, then Loss Of Consciousness 20 mg since Vomiting 24-Jun-04;25- Jun-04, 30 mg Risperdal C ORAL reduced on 16-Jul-04 Tavor C ORAL 0.5 mg tid, since 24-Jun-04 0.5 mg qid 07-Jun-04 Co-Diovan C valsartan 80 mg/hctz 12.5 mg 17-Jun-04 Date:08/05/04ISR Number: 4418572-XReport Type:Direct Company Report #CTU 224328 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify 10mgm - 1/2 Fatigue At Bedtime PS ORAL ORAL @HS Feeling Abnormal Hyperhidrosis Malaise Date:08/10/04ISR Number: 4422187-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12643821 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epiglottic Oedema Consumer Abilify PS Otsuka Initial or Prolonged Rash Pharmaceutical Rash Vesicular Company, Ltd. ORAL Date:08/10/04ISR Number: 4422194-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12459665 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Health Abilify PS Otsuka Rash Generalised Professional Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka 22-Feb-2006 08:31 AM Page: 505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Date:08/11/04ISR Number: 4422887-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12656682 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Abilify PS Otsuka Initial or Prolonged Pyrexia Pharmaceutical Salivary Hypersecretion Company, Ltd. ORAL Prozac C Date:08/11/04ISR Number: 4424994-3Report Type:Direct Company Report #CTU 224769 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coagulopathy Abilify PS 5 MG DAILY Multi-Organ Failure Risperidone SS 3 MG DAILY Neuroleptic Malignant Syndrome Rhabdomyolysis Date:08/12/04ISR Number: 4424004-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12643821 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Exfoliative Abilify PS Otsuka Initial or Prolonged Epiglottic Oedema Pharmaceutical Rash Company, Ltd. ORAL Rash Vesicular Date:08/16/04ISR Number: 4426667-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12633004 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Abilify PS Otsuka Dyskinesia Pharmaceutical Muscle Twitching Company, Ltd. ORAL 10 mg Swollen Tongue 13-May-04, 20 mg 16-Jun-04, 30 mg 20-Jun-04, Wellbutrin Sr C in the morning Valtrex C Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg 13-May-04, 20 mg 16-Jun-04, 30 mg 20-Jun-04, Zoloft I ORAL AM Zoloft I ORAL AM 22-Feb-2006 08:31 AM Page: 506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/04ISR Number: 4426789-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12609988 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Abilify PS Otsuka Initial or Prolonged Pancreatic Pseudocyst Professional Pharmaceutical Pancreatitis Company, Ltd. ORAL 5 mg/day White Blood Cell Count 12-Mar-04+inc Increased . to 10 mg/day 23-Mar-04;sto Lamictal SS Melatonin SS Seroquel C Reminyl C Effexor Xr C Nolvadex C Ambien C Xanax C Senokot C Remeron C Multivitamin C Date:08/16/04ISR Number: 4427794-3Report Type:Direct Company Report #CTU 224975 E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Aripiprazole PS Initial or Prolonged Syndrome Required Intervention to Prevent Permanent Impairment/Damage Date:08/17/04ISR Number: 4427302-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641304 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Phosphokinase Increased Company, Ltd. ORAL Confusional State Prolixin C Apothecon Dehydration Depakote C for "years" Insomnia Benadryl C 20-50 mg/day, Myoglobin Blood Increased pt has new Nausea rx, unsure if Psychotic Disorder started Suicidal Ideation Vomiting White Blood Cell Count Increased Date:08/17/04ISR Number: 4427349-0Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12661369 Age:19 YR Gender:Male I/FU:I Outcome PT Hospitalization - Adrenergic Syndrome Initial or Prolonged Anxiety Blood Creatine 22-Feb-2006 08:31 AM Page: 507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Drug Interaction Echocardiogram Abnormal Myalgia Report Source Product Role Manufacturer Route Dose Duration Nervousness Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Edronax I ORAL Date:08/17/04ISR Number: 4430178-5Report Type:Expedited (15-DaCompany Report #2004AP03992 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS Initial or Prolonged Consciousness Health Abilify SS ORAL 15 MG DAILY Drug Interaction Professional PO Other Diazepam SS ORAL 20 MG DAILY PO Droperidol SS INTRAMUSCULAR 5 MG PRN IM Lamictal "Burroughs Wellcome" SS Burroughs Wellcome ORAL 137 MG DAILY PO Midazolam SS INTRAMUSCULAR 10 MG PRN IM Epilim SS ORAL 1000 MG DAILY PO Levlen C Ferro-Gradumet /Aus/ C Nicabate C Mylanta C Date:08/18/04ISR Number: 4428928-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12660585 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/19/04ISR Number: 4429315-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12626081 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dry Skin Abilify PS Otsuka Erythema Pharmaceutical Face Oedema Company, Ltd. ORAL Flushing Pruritus Date:08/19/04ISR Number: 4429486-3Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12670212 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Abilify PS Otsuka Completed Suicide Pharmaceutical Psychotic Disorder Company, Ltd. ORAL Zyprexa C Solian C 22-Feb-2006 08:31 AM Page: 508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Temesta C Efexor C Date:08/23/04ISR Number: 4430795-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638078 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify PS Otsuka Fatigue Pharmaceutical Muscle Strain Company, Ltd. Increased to Neuroleptic Malignant 30 mg/day on Syndrome 04-Jun-04, Restlessness then Tremor discontinued. Paxil C decreased to 30 mg/day Topamax C Inc to 300 mg/day Lithium Carbonate C Trazodone Hcl C Apothecon Wellbutrin C Date:08/23/04ISR Number: 4433163-2Report Type:Expedited (15-DaCompany Report #2004054836 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Consumer Neurontin Condition Aggravated (Gabapentin) PS Fatigue Geodon (Ziprasidone Pain In Jaw Hydrochloride) Sexual Dysfunction (Ziprasidone) SS 40 MG Somnolence Risperidone Vision Blurred (Risperidone) SS Paracetamol (Paracetamol) SS Olanzapine (Olanzapine) SS Aripiprazole (Aripiprazole) SS Date:08/24/04ISR Number: 4431147-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12670618 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:08/24/04ISR Number: 4431149-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12669289 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Other Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C taken 4-5 years YR Zyprexa C several years YR Antibiotic C Antibiotic C Date:08/24/04ISR Number: 4431468-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12652228 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Coma Company, Ltd. ORAL 14 DAY Convulsion Cipramil C ORAL 10 mg, then Hyponatraemia 20 mg since Loss Of Consciousness 24-Jun-04;25- Muscle Spasms Jun-04, 30 mg Polydipsia Psychogenic Risperdal C ORAL reduced on Vomiting 16-Jul-04 Tavor C ORAL 0.5 mg tid, since 24-Jun-04 0.5 mg qid 07-Jun-04 Co-Diovan C valsartan 80 mg/hctz 12.5 mg 17-Jun-04 Date:08/24/04ISR Number: 4431470-0Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12668893 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 15mg 27-Feb-04 to 21-Apr-04, 20mg 22-Apr-04 to Olanzapine C Lorazepam C 10-Mar-2004 to 20-Apr-2004 and 06-Aug-2004 Date:08/25/04ISR Number: 4432039-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12564977 Age:25 YR Gender:Male I/FU:F Outcome PT Hospitalization - Disease Recurrence Initial or Prolonged Drug Ineffective 22-Feb-2006 08:31 AM Page: 510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL 15mg 23-Mar-04 to 30-Mar-04, increased to 30mg Venlafaxine Hcl C Panadol C Zopiclone C Date:08/25/04ISR Number: 4433701-XReport Type:Direct Company Report #CTU 225652 E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Atomoxetine 40 Mg Initial or Prolonged Aggression (Eli Lilly) PS Eli Lilly 40 MG DAILY Hair Plucking Aripiprazole Physical Abuse (Bristol-Myers -Squibb) SS Bristol-Myers-Squibb 7.5 MG DAILY Date:08/27/04ISR Number: 4434801-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12655866 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL 15mg 03-Oct-03 to 19-Mar-04,20m g 20-Mar-04 to 29-Jun-04, Date:08/30/04ISR Number: 4436372-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246468 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify Tabs PS Otsuka Twin Pregnancy Pharmaceutical Company, Ltd. ORAL Paxil C Prenatal Vitamins C Date:08/30/04ISR Number: 4436373-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12414009 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436374-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12459665 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Abilify PS Otsuka Rash Generalised Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Date:08/30/04ISR Number: 4436375-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498341 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Other Syndrome Company, Ltd. ORAL 2 DAY Seroquel SS Risperdal SS Effexor C Date:08/30/04ISR Number: 4436376-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12510095 Age:11 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL Increased to Tremor 10 mg/day. Drug held on 06-Feb-04; restarted the Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 10 mg/day. Drug held on 06-Feb-04; restarted the Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 10 mg/day. Drug held on 06-Feb-04; restarted the Prozac C Risperidone C Benadryl C Strattera C 22-Feb-2006 08:31 AM Page: 512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436377-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12545000 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Dose decr 24-Feb-04 (dose not specified); d/c Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose decr 24-Feb-04 (dose not specified); d/c Temazepam C Klonopin C Prozac C Date:08/30/04ISR Number: 4436378-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12545836 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL 7 days of 10 mg qAM 7 DAY Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 days of 10 mg qAM 7 DAY Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 days of 10 mg qAM 7 DAY Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 days of 10 mg qAM 7 DAY Date:08/30/04ISR Number: 4436379-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550935 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Suicidal Ideation Pharmaceutical Tardive Dyskinesia Company, Ltd. ORAL Init at 10 Torticollis mg/day "several months" ago;incr to Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Init at 10 mg/day "several months" 22-Feb-2006 08:31 AM Page: 513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ago;incr to Remeron C Tegretol C Klonopin C Date:08/30/04ISR Number: 4436380-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12553236 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Abilify PS Otsuka Corrected Interval Pharmaceutical Prolonged Company, Ltd. ORAL Date:08/30/04ISR Number: 4436381-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12559241 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL Clozapine C Date:08/30/04ISR Number: 4436382-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566717 Age:10 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Drug Ineffective Pharmaceutical Eye Rolling Company, Ltd. ORAL Initiated at Fatigue 2.5 mg/day; Feeling Abnormal 5mg Jun-03, Mood Swings 3.5mg Nausea 25-May-04, Somnolence Omega 3 Fish Oil C Weight Increased Date:08/30/04ISR Number: 4436383-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12569737 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2.5 mg in AM and 5 mg in PM Depakote SS chronic use Seroquel SS 200 mg and 400 mg Date:08/30/04ISR Number: 4436384-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12570461 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify PS Otsuka Musculoskeletal Stiffness Pharmaceutical Pollakiuria Company, Ltd. ORAL 30 mg then reduced to 15 22-Feb-2006 08:31 AM Page: 514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg (date not provided) 1 YR Effexor C Xanax C Lomotil C Cozaar C Bristol-Myers Squibb Company Date:08/30/04ISR Number: 4436385-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12571295 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Aripiprazole PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL 1 DAY Advair C Dose = 100/50 Klonopin C Depakote C Nexium C Neurontin C Lithium Carbonate C Methadone C Zyprexa C Wellbutrin Sr C Prednisone C Ultram C Bactrim Ds C Ambien C Date:08/30/04ISR Number: 4436387-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12576930 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436388-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12576955 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify PS Otsuka Suicidal Ideation Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436389-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12577557 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436390-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12577581 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apathy Abilify PS Otsuka Lethargy Pharmaceutical Psychomotor Hyperactivity Company, Ltd. 30 mg Jan-04 Somnolence decreased to Trance 15 mg approximately 3 weeks ago. Lomotil C Celexa C Wellbutrin C Date:08/30/04ISR Number: 4436391-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12577714 Age:11 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Zantac C Advil C Date:08/30/04ISR Number: 4436392-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578084 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436393-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578092 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436394-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578142 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436395-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578175 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Abilify PS Otsuka Hypertension Pharmaceutical Prescribed Overdose Company, Ltd. Dilantin C Lamotrigine C Date:08/30/04ISR Number: 4436396-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578183 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 10 mg/day Date:08/30/04ISR Number: 4436397-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578241 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436398-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578274 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dissociation Abilify PS Otsuka Dizziness Pharmaceutical Psychotic Disorder Company, Ltd. ORAL reduced to 5 mg/day Zyprexa C 2 YR Zoloft C 4 YR Date:08/30/04ISR Number: 4436399-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578597 Age:15 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Aripiprazole PS Otsuka Increased Pharmaceutical Company, Ltd. Buspar SS Bristol-Myers Squibb Company Date:08/30/04ISR Number: 4436400-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578605 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photophobia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436401-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578613 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photophobia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436402-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12578621 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photophobia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436403-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12579595 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Dose lowered to 15 mg/day Date:08/30/04ISR Number: 4436404-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12580155 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436405-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12580171 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Initiated at 5 mg/day Seroquel C Date:08/30/04ISR Number: 4436406-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12580338 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Benign Prostatic Abilify PS Otsuka Hyperplasia Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Initiated at Dysuria 5 mg/day; inc Fatigue on Headache 26-Apr-2004. Insomnia Lexapro C Sexual Dysfunction Buspar C Bristol-Myers Squibb Vision Blurred Company Neurontin C 22-Feb-2006 08:31 AM Page: 518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone Hcl C Apothecon Lipitor C Date:08/30/04ISR Number: 4436407-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12580882 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. lowered to 10 mg/day Date:08/30/04ISR Number: 4436408-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12580940 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Mydriasis Pharmaceutical Company, Ltd. ORAL 1 MON Flovent C Singulair C Albuterol Inhaler C Date:08/30/04ISR Number: 4436409-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12581112 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436410-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12581138 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436411-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12581252 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Eruption Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:08/30/04ISR Number: 4436412-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12581708 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C 22-Feb-2006 08:31 AM Page: 519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin C Radiation Therapy C Date:08/30/04ISR Number: 4436413-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12581906 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL started 5 mg, Feb-2004 one month later increased to 10 mg daily; Date:08/30/04ISR Number: 4436414-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12582417 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Date:08/30/04ISR Number: 4436415-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12582789 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436416-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12582961 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS Otsuka Initial or Prolonged Blood Creatine Pharmaceutical Phosphokinase Increased Company, Ltd. ORAL 1 WK Blood Pressure Decreased Abilify SS Otsuka Malaise Pharmaceutical Company, Ltd. ORAL 1 WK Date:08/30/04ISR Number: 4436417-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12582995 Age:6 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anticonvulsant Drug Level Abilify PS Otsuka Increased Pharmaceutical Sedation Company, Ltd. Depakote C 22-Feb-2006 08:31 AM Page: 520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436418-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated about 1-2 months prior to the report. Date:08/30/04ISR Number: 4436419-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583050 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify PS Otsuka Suicidal Ideation Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436420-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583068 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify PS Otsuka Suicidal Ideation Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436421-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583076 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify PS Otsuka Suicidal Ideation Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436422-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583092 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Abilify PS Otsuka Breast Discharge Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Lipitor C Lorazepam C Date:08/30/04ISR Number: 4436424-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583209 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436425-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583514 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Feeling Hot Abilify PS Otsuka Muscle Spasms Pharmaceutical Company, Ltd. ORAL Paxil Cr C Tarka C Dostinex C Date:08/30/04ISR Number: 4436426-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583530 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Abilify Tabs 10 Mg PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL 10 mg, then 15 mg once a day, then d/c after 6 days on 15 mg/day Glucophage C Bristol-Myers Squibb Company Glucotrol C Enteric Aspirin C Date:08/30/04ISR Number: 4436427-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12583696 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Schizophrenia Abilify PS Otsuka Pharmaceutical Company, Ltd. Zyprexa C Date:08/30/04ISR Number: 4436428-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12584280 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436429-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12584298 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Biting Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day "a while ago". 22-Feb-2006 08:31 AM Page: 522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436430-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12584710 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436431-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12584850 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify PS Otsuka Breast Tenderness Pharmaceutical Oligomenorrhoea Company, Ltd. ORAL Vaginal Haemorrhage Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Klonopin C Effexor C Trazodone Hcl C Apothecon Esgic C Robaxin C Zyrtec C Ibuprofen C Date:08/30/04ISR Number: 4436432-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12584868 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify Tabs 15 Mg PS Otsuka Sleep Disorder Pharmaceutical Company, Ltd. ORAL Valerian SS Vitamin C C Vitamin E C Calcium C Omega-3 C Multi-B C Date:08/30/04ISR Number: 4436433-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12585055 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urine Analysis Abnormal Abilify Tabs 30 Mg PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL Lower dose at initiation, increased to 30 mg/day Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Lower dose at initiation, increased to 30 mg/day 22-Feb-2006 08:31 AM Page: 523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coenzyme-Q10 C Concerta C Zoloft C Depakote C Date:08/30/04ISR Number: 4436434-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12585071 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL On aripiprazole for 6 months to a year Date:08/30/04ISR Number: 4436435-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12585089 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Strattera C Date:08/30/04ISR Number: 4436436-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12585535 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pollakiuria Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436437-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12585584 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436438-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12586178 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436439-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12586285 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Major Depression Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 1 YR Buspar C Bristol-Myers Squibb Company Xanax C Benadryl C Date:08/30/04ISR Number: 4436440-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12586525 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Insomnia Pharmaceutical Company, Ltd. ORAL 3 WK Date:08/30/04ISR Number: 4436441-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12586798 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436442-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12587341 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 MON Depakote C Date:08/30/04ISR Number: 4436443-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12587390 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 30 mg discontinued by patient; restarted at 5 mg (no 8 WK Geodon C Paxil C Date:08/30/04ISR Number: 4436444-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12587416 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 2 DAY Ativan C Wellbutrin C Multivitamin C Vitamin E C Reminyl C 22-Feb-2006 08:31 AM Page: 525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor Xr C Synthroid C Date:08/30/04ISR Number: 4436445-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12587424 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Haldol SS Date:08/30/04ISR Number: 4436446-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12587929 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Depakote C Date:08/30/04ISR Number: 4436447-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12588059 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Provigil C Diamox C Zanaflex C Klonopin C Trazodone Hcl C Apothecon Lamictal C Date:08/30/04ISR Number: 4436448-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12588448 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436449-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12588471 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gingivitis Abilify Tabs 10 Mg PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436450-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12588588 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Medication Error Pharmaceutical Other Overdose Company, Ltd. ORAL Accidential Somnolence ingestion Date:08/30/04ISR Number: 4436451-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12588687 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 10 mg/day, discontinued due to rash, reintroduced Date:08/30/04ISR Number: 4436452-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12589222 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL increased to 20 mg/day and physician is increasing the dose th Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL increased to 20 mg/day and physician is increasing the dose th Zyprexa C Prozac C Date:08/30/04ISR Number: 4436453-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12589248 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436454-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12589503 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Synthroid C Date:08/30/04ISR Number: 4436455-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12589966 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436456-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12590618 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Concerta C Clonidine C Date:08/30/04ISR Number: 4436457-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12590733 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg Jan-04; 7.5 mg Feb-04; 10 mg Mar-04; 15 mg on 20-Apr-04 Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg Jan-04; 7.5 mg Feb-04; 10 mg Mar-04; 15 mg on 20-Apr-04 Risperdal C Seroquel C Lipitor C Relafen C Metformin Hcl C Bristol-Myers Squibb Company 22-Feb-2006 08:31 AM Page: 528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436458-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12590741 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436459-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591145 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Fatigue Pharmaceutical Insomnia Company, Ltd. ORAL 7 DAY Tremor Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 DAY Risperdal C Date:08/30/04ISR Number: 4436460-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591657 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C Date:08/30/04ISR Number: 4436461-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591707 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Atenolol C Geneva Pharmaceuticals Technology, Corp. Date:08/30/04ISR Number: 4436462-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591939 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pigmentation Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/day, increased to 20 mg/day (date Zoloft C Clonazepam C 22-Feb-2006 08:31 AM Page: 529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436463-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591970 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Pain Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Vitamin C C Glucophage C Bristol-Myers Squibb Company Vitamin E C Claritin C Folic Acid C Prevacid C Vitamin B12 C Metronidazole C Lithium C Trileptal C Prozac C Date:08/30/04ISR Number: 4436464-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12591988 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Date:08/30/04ISR Number: 4436465-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12592077 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436466-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12592457 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Heart Rate Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436467-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12593117 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436468-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12593166 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C Date:08/30/04ISR Number: 4436469-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12594438 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Sensation In Eye Abilify Tabs 5 Mg PS Otsuka Lacrimation Increased Pharmaceutical Rhinorrhoea Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Clonidine C Several years' duration. Strattera C Risperdal C Several years' duration Paxil C Several years' duration Date:08/30/04ISR Number: 4436470-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12594529 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Abilify PS Otsuka Pain In Extremity Pharmaceutical Company, Ltd. Serzone SS Bristol-Myers Squibb Company Date:08/30/04ISR Number: 4436471-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12595112 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Parkinsonism Pharmaceutical Company, Ltd. ORAL Ativan C Date:08/30/04ISR Number: 4436472-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12595500 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Gabitril C Clonidine C Wellbutrin Sr C Date:08/30/04ISR Number: 4436473-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12595518 Age:17 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436474-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12595690 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Aricept C Date:08/30/04ISR Number: 4436475-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12595914 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Maculo-Papular Abilify PS Otsuka Sedation Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day; decreased to 7.5 mg/day; decreased to Colace C Adderall C 2 YR Benefiber C Date:08/30/04ISR Number: 4436476-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12595955 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg started approx Mar-04; then reduced to 2.5 mg/day 22-Feb-2006 08:31 AM Page: 532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436477-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12595997 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day, decreased to 1.25 mg/day, then Toprol Xl C Lisinopril C Plavix C Regulatory Health Authority South Africa Lipitor C Date:08/30/04ISR Number: 4436478-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12596086 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL increased from 10 mg to 15 mg then d/c Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL increased from 10 mg to 15 mg then d/c Ritalin C Concerta C Zoloft C Date:08/30/04ISR Number: 4436479-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12596094 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 25-Mar-04 = 5 mg qd for 1 wk, then incr to 2 tabs; 15mg Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 25-Mar-04 = 5 mg qd for 1 wk, then incr to 2 tabs; 15mg Concerta C Clonidine C 22-Feb-2006 08:31 AM Page: 533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436481-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12596102 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Clonidine C ORAL Concerta C ORAL (2 tabs qhs) Paxil C ORAL (1 tab qam) Date:08/30/04ISR Number: 4436482-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12596441 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify PS Otsuka Heart Rate Increased Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436483-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12596557 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436484-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12596805 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Renal Failure Acute Company, Ltd. 2 WK Date:08/30/04ISR Number: 4436485-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12597019 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify PS Otsuka Initial or Prolonged Dyspnoea Pharmaceutical Fear Company, Ltd. ORAL Hallucination, Visual Abilify SS Otsuka Homicidal Ideation Pharmaceutical Hyperventilation Company, Ltd. ORAL Increased Upper Airway Navane C ORAL Secretion Insomnia Muscle Tightness Nausea Suicidal Ideation 22-Feb-2006 08:31 AM Page: 534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436486-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12597217 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Exfoliative Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 18 DAY Insulin C Date:08/30/04ISR Number: 4436487-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12597225 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pain In Extremity Pharmaceutical Company, Ltd. ORAL 1 MON Date:08/30/04ISR Number: 4436488-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12597241 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Myalgia Company, Ltd. Depakote C Date:08/30/04ISR Number: 4436489-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12597795 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify PS Otsuka Insomnia Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436490-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12598397 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436491-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12598439 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify Tabs 5 Mg PS Otsuka Joint Stiffness Pharmaceutical Company, Ltd. ORAL incr to 1 3/4 tablets of 5 mg daily Zocor C 22-Feb-2006 08:31 AM Page: 535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436492-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12598470 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436493-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12598702 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436494-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12599064 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436495-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12599569 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Zyprexa C Date:08/30/04ISR Number: 4436496-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12600441 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Lethargy Pharmaceutical Muscle Contracture Company, Ltd. ORAL Myalgia Crestor C Rhinocort C Valium C Date:08/30/04ISR Number: 4436497-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12600821 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436498-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12601092 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436499-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12601928 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436500-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12601951 Age:11 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Abilify PS Otsuka Abnormal Pharmaceutical Company, Ltd. Lithium Carbonate C Date:08/30/04ISR Number: 4436501-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12601993 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Jaundice Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose: 2.5 mg/day, inc to 15 mg/day, decreased on Olanzapine C Lithium C Cogentin C Date:08/30/04ISR Number: 4436502-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12602488 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436503-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12604534 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C 22-Feb-2006 08:31 AM Page: 537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436504-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12604971 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 10 mg/day Mar-04; then 15 mg/day MON Lico3 C 25 YR Date:08/30/04ISR Number: 4436505-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12605812 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 10 Mg PS Otsuka Dysgeusia Pharmaceutical Headache Company, Ltd. ORAL 10 DAY Insomnia Xyrem C Ambien C Klonopin C Xanax C Wellbutrin C Advair C Multivitamin C Date:08/30/04ISR Number: 4436506-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12606067 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 12 DAY Lamictal C Date:08/30/04ISR Number: 4436507-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12606497 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436508-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12606661 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Reduced to 15 mg/day on 04-Jun-2004 22-Feb-2006 08:31 AM Page: 538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436509-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12607065 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436510-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12607347 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436511-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12607420 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Fluvoxamine C Date:08/30/04ISR Number: 4436512-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608014 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Prescribed Overdose Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day, gradually increased Prolixin C Apothecon 3 WK Depakote C Lorazepam C Date:08/30/04ISR Number: 4436513-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608147 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify PS Otsuka Excitability Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436514-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608246 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436515-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608253 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436516-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608261 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436517-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608303 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL Dosing discontinued during the patient's hospitalizati Zoloft C for at least one year Date:08/30/04ISR Number: 4436518-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608824 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Starting dose 2.25mg, increased to a maximum dose of 20 Date:08/30/04ISR Number: 4436519-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608857 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL decreased to 2.5 mg/day, then discontinued 22-Feb-2006 08:31 AM Page: 540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436520-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12609079 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastritis Abilify PS Otsuka Ulcer Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436521-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12609483 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436522-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12609947 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day Nov-2004; increased to 20 mg/day in Lithium C Lamictal C Date:08/30/04ISR Number: 4436523-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12611018 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Anorexia Pharmaceutical Other Depression Company, Ltd. ORAL 3 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Date:08/30/04ISR Number: 4436524-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12611562 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436525-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12611570 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436526-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12611901 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436527-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12612099 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Post Procedural Abilify PS Otsuka Initial or Prolonged Haemorrhage Pharmaceutical Company, Ltd. ORAL 1 YR Date:08/30/04ISR Number: 4436528-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12612305 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL initiated May or June 2003 Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL initiated May or June 2003 Lithium C Date:08/30/04ISR Number: 4436529-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12612321 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Lexapro C Date:08/30/04ISR Number: 4436530-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12613030 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Lexapro C 10 mgday prior to the start of aripiprazole, 20 mg/day Humalog C Coreg C Lasix C Lotensin C Prevacid C Lovastatin C Aspirin C 22-Feb-2006 08:31 AM Page: 542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436531-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12613113 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sexual Dysfunction Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436532-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12613733 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Prescribed Overdose Pharmaceutical Speech Disorder Company, Ltd. ORAL Celexa C Divalproex Sodium C Alprazolam C Date:08/30/04ISR Number: 4436533-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12614525 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Blood Glucose Increased Pharmaceutical Psychomotor Hyperactivity Company, Ltd. ORAL 10 mg on 28-Apr-04; dose increased to 20 mg every Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg on 28-Apr-04; dose increased to 20 mg every Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg on 28-Apr-04; dose increased to 20 mg every Lorazepam C Ziprasidone C Clonazepam C Gabapentin C 600 MG TWO TABS BID Paxil C Terazosin Hcl C 1 cap HS Terazosin Hcl C 1 cap HS Lithium Carbonate C HS Propranolol Hcl C Quetiapine Fumarate C ORAL tapering off at time of rpt-1.5 tab HS X 7 days, then 1 HS X7 Synthroid C 22-Feb-2006 08:31 AM Page: 543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metformin Hcl C Bristol-Myers Squibb Company Alpha-Tocopherol C Paroxetine Hcl C .5 TAB BEDTIME FOR 7 DAYS, THEN ONE TAB AT BEDTIME Date:08/30/04ISR Number: 4436534-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12615035 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Increased Appetite Pharmaceutical Weight Increased Company, Ltd. ORAL decreased to 10 mg/day, then discontinued Topamax C Lasix C Potassium C Seroquel C Date:08/30/04ISR Number: 4436535-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12615134 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify PS Otsuka Dysphagia Pharmaceutical Myalgia Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Methocarbamol C Klonopin C Codeine Sulfate C Ibuprofen Sr C Benadryl Cream C Muscle Relaxant C Date:08/30/04ISR Number: 4436536-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12616637 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436537-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12617718 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 20 Mg PS Otsuka Dyskinesia Pharmaceutical Tremor Company, Ltd. ORAL 2 MON Abilify Tabs 20 Mg SS Otsuka 22-Feb-2006 08:31 AM Page: 544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL 2 MON Ativan C Vitamins C Maalox C Date:08/30/04ISR Number: 4436539-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12619110 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Renal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C at bedtime Fish Oil C Date:08/30/04ISR Number: 4436540-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12619201 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS Otsuka Initial or Prolonged Cerebrovascular Accident Pharmaceutical Other Depression Company, Ltd. ORAL Jun-2003 Heart Rate Decreased (dose unknown); increased to 30mg Depakote C Monopril C Bristol-Myers Squibb Company Lexapro C Date:08/30/04ISR Number: 4436541-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12619656 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Therapeutic Response Pharmaceutical Unexpected Company, Ltd. Date:08/30/04ISR Number: 4436542-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12619664 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436543-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12619698 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Clonazepam C 22-Feb-2006 08:31 AM Page: 545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436544-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12620142 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dissociation Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 10mg, 1/2 tablet taken in the evening for 3 to 4 days in Synthroid C Multivitamin C Date:08/30/04ISR Number: 4436545-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12620308 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL 3 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Strattera C Zoloft C Fluoride C Multivitamin C Date:08/30/04ISR Number: 4436546-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12621710 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Abilify PS Otsuka Initial or Prolonged Muscle Rigidity Pharmaceutical Pyrexia Company, Ltd. Date:08/30/04ISR Number: 4436547-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12622007 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Abilify PS Otsuka Influenza Like Illness Pharmaceutical Rash Erythematous Company, Ltd. ORAL Lithium C Glipizide C Zocor C Paxil C Toprol C Date:08/30/04ISR Number: 4436548-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12622155 Age:59 YR Gender:Female I/FU:F Outcome PT Other Blood Potassium Decreased Dizziness Heat Stroke Myocardial Infarction 22-Feb-2006 08:31 AM Page: 546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Rash Vomiting Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 MON Date:08/30/04ISR Number: 4436549-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12622361 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperthyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Neurontin C Tegretol C Date:08/30/04ISR Number: 4436550-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12622387 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Topamax C Date:08/30/04ISR Number: 4436551-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623195 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 5 Mg PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Tenex C Trileptal C Date:08/30/04ISR Number: 4436552-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623229 Age:35 YR Gender:Male I/FU:I Outcome PT Aphasia Dysarthria Headache Hemiparesis Joint Stiffness Migraine Muscular Weakness Musculoskeletal Stiffness 22-Feb-2006 08:31 AM Page: 547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg 1 tablet daily in the evenings taken in Avandia C Atenolol C Geneva Pharmaceuticals Technology, Corp. Lipitor C Plendil C Date:08/30/04ISR Number: 4436553-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623278 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vitiligo Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 7.5 mg/day one month ago; increased to Prozac C Taken for a "few years" Concerta C Taken for a "few years" Date:08/30/04ISR Number: 4436554-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623294 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436555-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623450 Age:10 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436556-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623468 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436557-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623476 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436558-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623930 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photosensitivity Reaction Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436559-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12624177 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436560-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12624193 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify PS Otsuka Grimacing Pharmaceutical Company, Ltd. approximately "15 or 20 mg once a day" Date:08/30/04ISR Number: 4436561-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12624466 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intraocular Pressure Test Abilify PS Otsuka Visual Field Defect Pharmaceutical Company, Ltd. Hypertension Medication C Proscar C Date:08/30/04ISR Number: 4436562-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12624482 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C 22-Feb-2006 08:31 AM Page: 549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436563-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12625976 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436564-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12625992 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Disorder Abilify PS Otsuka Initial or Prolonged Haematemesis Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436565-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12626644 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436566-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12627360 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 MON Date:08/30/04ISR Number: 4436567-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12627378 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. 1 MON Effexor C 5 YR Date:08/30/04ISR Number: 4436568-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12627576 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Depression Pharmaceutical Company, Ltd. ORAL 10mg 03-Dec-03; titrated up to 15mg on 15-Mar-04. 22-Feb-2006 08:31 AM Page: 550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436569-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12628061 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436570-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12628186 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Dyspepsia Pharmaceutical Nausea Company, Ltd. ORAL Dosing Weight Decreased initiated at 15 mg and increased to 30 mg. 3 MON Date:08/30/04ISR Number: 4436571-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12628236 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Voltaren C Risperdal C Date:08/30/04ISR Number: 4436572-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12629051 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Lethargy Pharmaceutical Company, Ltd. ORAL Stopped all medications for 4 days during Jun-2004. Clonazepam C Date:08/30/04ISR Number: 4436573-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12629168 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Micturition Urgency Abilify PS Otsuka Urinary Incontinence Pharmaceutical Company, Ltd. ORAL Dantrium C Effexor Xr C 22-Feb-2006 08:31 AM Page: 551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436574-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12629275 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 10 Mg PS Otsuka Hunger Pharmaceutical Movement Disorder Company, Ltd. ORAL Nausea Date:08/30/04ISR Number: 4436575-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12629572 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Dystonia Pharmaceutical Company, Ltd. ORAL Approx 1 yr ago, 15 mg 2 tablets daily; then dose lowered Lexapro C Wellbutrin C init. approx 1 yr ago @ 150 mg/day;approx 1 mo. ago Klonopin C Date:08/30/04ISR Number: 4436576-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12630455 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify PS Otsuka Prescribed Overdose Pharmaceutical Pruritus Company, Ltd. ORAL Twin Pregnancy Paxil C Urinary Tract Infection Date:08/30/04ISR Number: 4436577-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12632089 Age:15 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphonia Abilify PS Otsuka Dystonia Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436578-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12632790 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C 22-Feb-2006 08:31 AM Page: 552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436579-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12634259 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436580-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12634416 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Thinking Abnormal Pharmaceutical Company, Ltd. ORAL Initiated at a lower dose; titrated to 30mg about 4 months ago. Zoloft C Initiated at 100 mg/day Metformin Hcl C Bristol-Myers Squibb Company Ibuprofen C Date:08/30/04ISR Number: 4436581-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12634580 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose: 15 mg/day reduced to 10 mg/day, then 5 mg/day Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose: 15 mg/day reduced to 10 mg/day, then 5 mg/day Date:08/30/04ISR Number: 4436582-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12635405 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436583-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12635413 Age:62 YR Gender:Female I/FU:I Outcome PT Arthralgia Headache 22-Feb-2006 08:31 AM Page: 553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Muscle Spasms Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Stopped after 3 days, resumed on 08-Jul-2004 Synthroid C Klonopin C Thioridazine C Date:08/30/04ISR Number: 4436584-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12636221 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436585-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12636247 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify PS Otsuka Paraphilia Pharmaceutical Company, Ltd. Geodon C Depakote C Klonopin C Zyprexa C Date:08/30/04ISR Number: 4436586-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12636486 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436587-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12636916 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL Aminotransferase Zocor C Increased 22-Feb-2006 08:31 AM Page: 554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436588-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12636924 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 MON Geodon C Antidepressant C Date:08/30/04ISR Number: 4436589-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12636940 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436590-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12637583 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Spontaneous Penile Abilify PS Otsuka Erection Pharmaceutical Company, Ltd. ORAL Increased to 15 mg/day; decreased to 10 mg/day 2 MON Melatonin C 3-6 MG/DAY Advair C 2/50-50 Singulair C Albuterol C 2 puffs/day Date:08/30/04ISR Number: 4436591-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436592-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638102 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436593-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638110 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436594-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638326 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Dyspnoea Pharmaceutical Insomnia Company, Ltd. ORAL decreased to Tardive Dyskinesia 5 mg/day Protonix C Vitamin B Complex C Vitamin E C Multivitamin C Zyprexa C Date:08/30/04ISR Number: 4436595-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638391 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL reduced to 5 mg (no date) Effexor C Date:08/30/04ISR Number: 4436596-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638565 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinson'S Disease Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Simvastatin C Sinemet C Bristol-Myers Squibb Company ORAL 25/100 MG controlled release tablet bid Metoprolol C Diformin C 1 YR Synthroid C Hctz C Protonix C Mirapex C Allopurinol C 2 YR Date:08/30/04ISR Number: 4436597-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638573 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Parkinson'S Disease Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Sinemet C Bristol-Myers Squibb Company 25/100 mg once a day; 50/200 mg five daily Amantadine C 22-Feb-2006 08:31 AM Page: 556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevacid C Potassium C Multivitamins C Requip C Diuretic C Date:08/30/04ISR Number: 4436598-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638854 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436599-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638912 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Abilify PS Otsuka Initial or Prolonged Dystonia Pharmaceutical Musculoskeletal Stiffness Company, Ltd. Date:08/30/04ISR Number: 4436600-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12639332 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. Zoloft C Date:08/30/04ISR Number: 4436601-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12639357 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. decreased to 10 mg Mar-04; then discontinued May-04 Abilify SS Otsuka Pharmaceutical Company, Ltd. decreased to 10 mg Mar-04; then discontinued May-04 Date:08/30/04ISR Number: 4436602-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12639738 Age:64 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Acute Psychosis Abilify PS Otsuka Akathisia Pharmaceutical Anxiety Company, Ltd. Psychomotor Hyperactivity Haldol C Treatment Noncompliance Cogentin C Valproate C Date:08/30/04ISR Number: 4436603-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12640041 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Option of an additional dose of 10 mg/day Prozac C Date:08/30/04ISR Number: 4436604-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12640371 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Paraesthesia Pharmaceutical Company, Ltd. ORAL started @ 5 mg/day; increased to 10 mg/day; increased to Date:08/30/04ISR Number: 4436605-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12640991 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Abilify PS Otsuka Constipation Pharmaceutical Fatigue Company, Ltd. Myalgia Pruritus Thinking Abnormal Date:08/30/04ISR Number: 4436606-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641155 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436607-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641304 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436608-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641668 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436609-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641726 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 9 MON Date:08/30/04ISR Number: 4436610-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641783 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Hydrochlorothiazide C Ritalin C Trileptal C Date:08/30/04ISR Number: 4436611-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12642211 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL initially 5 mg 2 MON Lexapro C Wellbutrin C Trazodone Hcl Tabs C Apothecon Date:08/30/04ISR Number: 4436612-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12642450 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify PS Otsuka Pharmaceutical Company, Ltd. Trileptal C 22-Feb-2006 08:31 AM Page: 559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436613-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12642492 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436614-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12643888 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 MON Lexapro C Date:08/30/04ISR Number: 4436615-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12644860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Headache Pharmaceutical Hemiparesis Company, Ltd. ORAL Joint Stiffness Date:08/30/04ISR Number: 4436616-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12645156 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Walking Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/day Date:08/30/04ISR Number: 4436617-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12645578 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Abilify PS Otsuka Cogwheel Rigidity Pharmaceutical Confusional State Company, Ltd. Depression Diabetes Mellitus Insomnia Date:08/30/04ISR Number: 4436618-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12645859 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Abilify PS Otsuka Initial or Prolonged Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Initiated 1 year prior to the report; discontinued 6-9 months 22-Feb-2006 08:31 AM Page: 560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochlorothiazide C 12.5 or 25 mg daily Date:08/30/04ISR Number: 4436619-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12646089 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Insomnia Pharmaceutical Weight Increased Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Lorazepam C Neurontin C Ativan C Lexapro C Date:08/30/04ISR Number: 4436620-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12646717 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 5 Mg PS Otsuka Feeling Abnormal Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day, decreased to 5 mg/day within 4-5 2 MON Lithium C Date:08/30/04ISR Number: 4436621-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12646840 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436622-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12646972 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intraocular Pressure Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. Lexapro C Trileptal C Date:08/30/04ISR Number: 4436623-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12647251 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Mood Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose for the 22-Feb-2006 08:31 AM Page: 561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report last 1 1/2 months is 10 mg/day 6 MON Prozac C Lexapro C 2 WK Synthroid C Date:08/30/04ISR Number: 4436624-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12647277 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Inappropriate Affect Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436625-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12647327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436626-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12647350 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 5 mg 11-Sep-03; increased gradually to 20 mg Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg 11-Sep-03; increased gradually to 20 mg Haldol C Nystatin Cream C Westwood Vitamin C C Colace C Singulair C Advair C Date:08/30/04ISR Number: 4436627-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12647657 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify PS Otsuka Initial or Prolonged Prescribed Overdose Pharmaceutical Psychotic Disorder Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436628-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648002 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436629-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648283 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day, increased to 15 mg/day 9 MON Lisinopril C Lithobid C Asa C Date:08/30/04ISR Number: 4436630-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648309 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436631-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648317 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436632-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648333 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436633-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648341 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436634-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648705 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day Date:08/30/04ISR Number: 4436635-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648762 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/day; inc to 20 mg/day on 10-Jun-04, Date:08/30/04ISR Number: 4436636-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648796 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Agitation Pharmaceutical Company, Ltd. ORAL 1 YR Adderall C Celexa C Zyrtec C Date:08/30/04ISR Number: 4436638-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648879 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436639-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648911 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Somnolence Pharmaceutical Weight Decreased Company, Ltd. ORAL incr to 10 mg, 22-Jul-04 Norvasc C 22-Feb-2006 08:31 AM Page: 564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436640-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648929 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Pharmaceutical Company, Ltd. Effexor Xr C Seroquel C Date:08/30/04ISR Number: 4436641-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649620 Age:13 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C Date:08/30/04ISR Number: 4436642-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649737 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg/day on 12-Dec-03; inc to 15mg/day on Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg/day on 12-Dec-03; inc to 15mg/day on Trazodone Hcl C Apothecon 100-200 mg at bedtime Date:08/30/04ISR Number: 4436643-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649745 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436644-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649760 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C 22-Feb-2006 08:31 AM Page: 565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436645-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12650792 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day Date:08/30/04ISR Number: 4436646-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12650800 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day Date:08/30/04ISR Number: 4436647-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12650875 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436648-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12651360 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swelling Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436649-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12651477 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify PS Otsuka Pharmaceutical Company, Ltd. 5 DAY Date:08/30/04ISR Number: 4436650-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12652129 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicidal Ideation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436651-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12652418 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Insulin C Zyprexa C Date:08/30/04ISR Number: 4436652-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12652780 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL Decreased to 15 mg/day in Apr-04; decreased to 10 mg/day on Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 15 mg/day in Apr-04; decreased to 10 mg/day on Lexapro C Neurontin C Date:08/30/04ISR Number: 4436653-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12653473 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Pain Abilify PS Otsuka Hypertrophy Breast Pharmaceutical Company, Ltd. ORAL 8 WK Lexapro C Neurontin C Date:08/30/04ISR Number: 4436654-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12653556 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Abilify PS Otsuka Initial or Prolonged Psychotic Disorder Pharmaceutical Suicidal Ideation Company, Ltd. ORAL Geodon C Lithium C Prozac C Risperdal C Serzone C Bristol-Myers Squibb Company Zyprexa C Date:08/30/04ISR Number: 4436655-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12654067 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Osteoarthritis Pharmaceutical Skin Discolouration Company, Ltd. ORAL Initial dosage 22-Feb-2006 08:31 AM Page: 567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report unknown. Restarted on 10 mg/day. Lexapro C Levoxyl C Date:08/30/04ISR Number: 4436656-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12654083 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Disorder Abilify PS Otsuka Insomnia Pharmaceutical Weight Increased Company, Ltd. ORAL 1 YR Lamictal C Gabitril C Lorazepam C Date:08/30/04ISR Number: 4436657-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12654570 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Parkinsonism Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436658-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12654596 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436659-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12654752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/04ISR Number: 4436660-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12655775 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Prescribed Overdose Company, Ltd. ORAL one 20 mg tablet and one 15 mg tablet once a day. Seroquel C 6-9 months Zoloft C Clonazepam C 22-Feb-2006 08:31 AM Page: 568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436661-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12655833 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot And Cold Abilify PS Otsuka Musculoskeletal Stiffness Pharmaceutical Nausea Company, Ltd. ORAL Pain Provigil C Renal Pain Topamax C Buspar C Bristol-Myers Squibb Company Adderall Xr C Claritin C Date:08/30/04ISR Number: 4436662-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12657060 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Abilify PS Otsuka Initial or Prolonged Depressed Level Of Pharmaceutical Consciousness Company, Ltd. 6 MON Unresponsive To Pain Prozac C Stimuli Strattera C Date:08/30/04ISR Number: 4436663-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12657078 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436664-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12657086 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/04ISR Number: 4436665-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12657268 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Prozac C Xanax C Date:08/30/04ISR Number: 4436688-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649737 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abortion Spontaneous Initial or Prolonged Drug Exposure During Pregnancy 22-Feb-2006 08:31 AM Page: 569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg on 12-Dec-03; inc to 15mg on 18-Feb-04. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg on 12-Dec-03; inc to 15mg on 18-Feb-04. Trazodone Hcl C Apothecon ORAL 100-200 mg at bedtime 6 YR Date:08/30/04ISR Number: 4436807-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12676730 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Urinary Tract Infection Company, Ltd. ORAL Date:08/30/04ISR Number: 4436808-6Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12676128 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Other Treatment Noncompliance Pharmaceutical Company, Ltd. ORAL Lorazepam C Valerian Extract C Date:08/31/04ISR Number: 4437605-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12677753 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Abilify PS Otsuka Orthostatic Hypotension Pharmaceutical Company, Ltd. ORAL Date:08/31/04ISR Number: 4437800-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12615712 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Aripiprazole PS Otsuka Initial or Prolonged Depressive Symptom Professional Pharmaceutical Company, Ltd. ORAL Glyburide C Geneva Pharmaceuticals Technology, Corp. Ranitidine C 22-Feb-2006 08:31 AM Page: 570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrocodone + Acetaminophen C 7.5/500 mg PRN Etodolac C Clotrimazole C TOPICAL Date:08/31/04ISR Number: 4439629-3Report Type:Direct Company Report #CTU 225962 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Kidney Transplant Abilify PS UNCERTAIN Initial or Prolonged Rejection Prograf C Oedema Peripheral Prednisone C Renal Failure Accupril C Actiq C Acyclovir C Ambien C Imitrex C Loestrin C Mvi C Mylanta C Neurontin C Prevacid C Risedronate C Robitussin With Codeine C Slo-Mag C Xanax C Zantac C Zoloft C Date:09/01/04ISR Number: 4439139-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12662870 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Abilify PS Otsuka Initial or Prolonged Blunted Affect Pharmaceutical Confusional State Company, Ltd. ORAL 4 WK Disorientation Lorazepam C Hepato-Lenticular Degeneration Date:09/01/04ISR Number: 4443526-7Report Type:Expedited (15-DaCompany Report #HQWYE480223AUG04 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Caesarean Section Health Effexor Xr Congenital Bladder Professional (Venlafaxine Anomaly Company Hydrochloride, Drug Exposure During Representative Capsule, PS TRANSPLACENTAL 450 MG 1X PER Pregnancy 1 DAY, Electroconvulsive Therapy TRANSPLACENTA Meningomyelocele L Multiple Congenital Abilify Abnormalities (Aripiprazole, ) SS TRANSPLACENTAL SEE IMAGE Premature Baby Ambien (Zolpidem Tartrate, ) SS TRANSDERMAL 20 MG 1X PER 1 DAY, 22-Feb-2006 08:31 AM Page: 571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TRANSPLACENTA L Ativan (Lorazepam, Unspec) SS TRANSDERMAL 2 MG 1X PER 1 DAY, TRANSPLACENTA L Ativan (Lorazepam, Unspec) SS TRANSPLACENTAL 2 MG 1X PER 1 DAY, TRANSPLACENTA L Ativan (Lorazepam, Unspec) SS TRANSPLACENTAL TITRATED TO 1 MG FOUR TIMES DAILY, TRANSPLACENTA L Gabitril (Tiagabine Hydrochloride) SS TRANSPLACENTAL 12 MG 1X PER 1 DAY, TRANSPLACENTA L Klonopin (Clonazepam, ) SS TRANSPLACENTAL 2 MG 1X PER 1 DAY, TRANSPLACENTA L Remeron (Mirtazapine, ) SS TRANSPLACENTAL 45 MG 1X PER 1 DAY, TRANSPLACENTA L Remeron (Mirtazapine, ) SS TRANSPLACENTAL 60 MG 1X PER 1 DAY, TRANSPLACENTA L Date:09/02/04ISR Number: 4439603-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12682092 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Abilify PS Otsuka Initial or Prolonged Intestinal Obstruction Pharmaceutical Company, Ltd. ORAL Cogentin C 4 YR Serzone C Bristol-Myers Squibb Company 4 YR Clonazepam C 4 YR Singulair C Levitra C Taken prior to sex Claritin D C 22-Feb-2006 08:31 AM Page: 572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/04ISR Number: 4439605-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12678884 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Abilify PS Otsuka Initial or Prolonged Haemolysis Pharmaceutical Other Restlessness Company, Ltd. Diazepam SS Quetiapine C Initiated at 1600 mg/day tapered to 300 mg/day on 12-Aug-2004. Promethazine C Tenormin C Date:09/03/04ISR Number: 4440217-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12683694 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mental Status Changes Abilify PS Otsuka Other Muscle Rigidity Pharmaceutical Sudden Death Company, Ltd. 5 mg/day x 4 days, then 10 mg/day x 4 days, then 15 mg/day for 30 Celebrex C Haldol C Evening Keppra C Lipitor C Zoloft C Ambien C Folic Acid C Geodon C Loperamide C Tussin Cf Cough C Saline C NASAL Colace C Date:09/07/04ISR Number: 4444815-2Report Type:Direct Company Report #CTU 226501 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Feeling Abnormal Abilify 15 Mg, Intervention to Musculoskeletal Stiffness Otsuka PS Otsuka 15 MG DAILY Prevent Permanent Nuchal Rigidity IN AM Impairment/Damage Celexa C Mirtazapine C Lorazepam C Date:09/08/04ISR Number: 4443488-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685996 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Cardiac Murmur Pharmaceutical Other Company, Ltd. ORAL 10 mg Dec-03; 15 mg; then 22-Feb-2006 08:31 AM Page: 573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 10 mg one tablet once a day during Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg Dec-03; 15 mg; then 10 mg one tablet once a day during Date:09/08/04ISR Number: 4443492-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12684007 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Speech Disorder Pharmaceutical Tongue Oedema Company, Ltd. ORAL Date:09/08/04ISR Number: 4443499-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12686663 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Zyprexa C Celexa C Date:09/09/04ISR Number: 4448489-6Report Type:Direct Company Report #CTU 226759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Seroquel 25 Mg PS ORAL 2 TABS DAILY Initial or Prolonged ORAL Abilify 10 Mg SS OROPHARINGEAL 1 TAB DAILY OROPHARINGEAL Date:09/09/04ISR Number: 4448836-5Report Type:Expedited (15-DaCompany Report #DSA_24882_2004 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Health Ativan PS 2 MG QD Initial or Prolonged Drug Exposure During Professional Ativan SS 1 MG QID Congenital Anomaly Pregnancy Effexor-Xr SS 450 MG QD Required Electroconvulsive Therapy Abilify SS 20 MG QD Intervention to Pregnancy Abilify SS 15 MG QD Prevent Permanent Premature Labour Ambien SS 3 MG QD Impairment/Damage Gabitril SS 12 MG QD Klonopin SS 2 MG QD Remeron SS 45 MG QD Remeron SS 60 MG QD 22-Feb-2006 08:31 AM Page: 574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4448838-9Report Type:Expedited (15-DaCompany Report #DSA_24883_2004 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Health Ativan PS TRANSPLACENTAL 2 MG QD Initial or Prolonged Congenital Ectopic Professional TRAN-P Congenital Anomaly Bladder Ativan SS TRANSPLACENTAL 1 MG QID Required Drug Exposure During TRAN-P Intervention to Pregnancy Effexor-Xr SS TRANSPLACENTAL 450 MG QD Prevent Permanent Meningomyelocele TRAN-P Impairment/Damage Premature Baby Abilify SS TRANSPLACENTAL 20 MG QD TRAN-P Abilify SS TRANSPLACENTAL 15 MG QD TRAN-P Ambien SS TRANSPLACENTAL 3 GM QD TRAN-P Gabitril SS TRANSPLACENTAL 12 MG QD TRAN-P Klonopin SS TRANSPLACENTAL 2 MG TRAN-P Remeron SS TRANSPLACENTAL 45 MG QD TRAN-P Remeron SS TRANSPLACENTAL 60 MG QD TRAN-P Date:09/13/04ISR Number: 4448054-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12655775 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Health Abilify PS Otsuka Initial or Prolonged Viral Infection Professional Pharmaceutical Company, Ltd. ORAL one 20 mg tablet and one 15 mg tablet once a day. Seroquel C 6-9 months Zoloft C Clonazepam C Date:09/13/04ISR Number: 4449663-5Report Type:Direct Company Report #CTU 226913 E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Abilify 10mg Bms PS Bms ORAL 10MG QD Initial or Prolonged Hyperhidrosis ORAL Orthostatic Hypotension Atenolol C Respiratory Rate Mirtazapine C Increased Tramadol C Tremor Aspirin C Date:09/15/04ISR Number: 4450049-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12692117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify Tabs 10 Mg PS Otsuka Drug Withdrawal Syndrome Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Muscle Strain Zyprexa SS ORAL Nausea Fluctine C ORAL 22-Feb-2006 08:31 AM Page: 575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/04ISR Number: 4451182-7Report Type:Direct Company Report #CTU 227123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Aripiprazole 15mg PS ORAL 15 MG QD PO Mobility Decreased Lamotrigine 25 Mg SS ORAL 25 MG BID PO Clonazepam C Nitroglycerin C Tramadol Hcl C Aspirin Ec C Clopidogrel Bisulfate C Isosorbide Mononitrate C Lisinopril C Metformin Hcl C Metoprolol Tartrate C Gabapentin C Alprostadil C Simvastatin C Date:09/17/04ISR Number: 4452076-3Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12693727 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 15mg 07-Mar-04 to 11-Jul-04, 30mg 12-Jul-04 to Depakin C Rivotril C Date:09/20/04ISR Number: 4453676-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700696 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:09/21/04ISR Number: 4454676-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649737 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Health Abilify PS Otsuka Initial or Prolonged Pregnancy Professional Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg on 12-Dec-03; inc to 15mg on 18-Feb-04. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg on 12-Dec-03; 22-Feb-2006 08:31 AM Page: 576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report inc to 15mg on 18-Feb-04. Trazodone Hcl C Apothecon ORAL 100-200 mg at bedtime 6 YR Prenatal Vitamin C Date:09/22/04ISR Number: 4455826-5Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12676128 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Abilify Tabs 15 Mg PS Otsuka Other Schizophrenia Professional Pharmaceutical Treatment Noncompliance Company, Ltd. ORAL Lorazepam C Valerian Extract C Date:09/22/04ISR Number: 4455829-0Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12684007 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Health Abilify PS Otsuka Dystonia Professional Pharmaceutical Speech Disorder Company, Ltd. ORAL Tongue Oedema Metformine C Lithium C Parnate C Cholesterol Medication C Date:09/22/04ISR Number: 4459297-4Report Type:Direct Company Report #CTU 227803 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Abilify 15mg Bms PS Bms ORAL 15 QHS ORAL Intervention to Effexor C Prevent Permanent Klonopin C Impairment/Damage Ativan C Levothyroxine C Lipitor C Lasix C Lotrel C Date:09/22/04ISR Number: 4459724-2Report Type:Direct Company Report #CTU 227804 E Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Abilify Initial or Prolonged -Aripiprazole- PS ORAL 15MG PO QD Lopressor C Aspirin C Date:09/24/04ISR Number: 4457948-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12669289 Age:56 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Breast Cancer Consumer Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C taken 4-5 years YR Zyprexa C several years YR Antibiotic C Antibiotic C Date:09/24/04ISR Number: 4457949-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12702064 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Abilify PS Otsuka Abnormal Pharmaceutical Ventricular Hypertrophy Company, Ltd. ORAL 6 WK Date:09/24/04ISR Number: 4461610-9Report Type:Direct Company Report #CTU 227980 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activities Of Daily Abilify PS Living Impaired Difficulty In Walking Musculoskeletal Stiffness Neck Deformity Neuroleptic Malignant Syndrome Speech Disorder Therapy Non-Responder Date:09/27/04ISR Number: 4459195-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12673729 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Abilify PS Otsuka Blood Alkaline Pharmaceutical Phosphatase Increased Company, Ltd. ORAL Musculoskeletal Stiffness Psychomotor Skills Impaired 22-Feb-2006 08:31 AM Page: 578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/04ISR Number: 4462100-XReport Type:Direct Company Report #CTU 228060 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Torticollis Aripiprazole (Abilify) Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 5 MG PO TABLETS Seroquel C Date:09/27/04ISR Number: 4462687-7Report Type:Expedited (15-DaCompany Report #2004-120361-NL Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Caesarean Section Health Remeron /Net/ PS ORAL 45 MG DAILY Congenital Anomaly Professional ORAL Drug Exposure During Remeron /Net/ SS ORAL 60 MG DAILY Pregnancy ORAL Premature Baby Ambien SS ORAL 20 MG DAILY ORAL Effexor-Xr SS ORAL 450 MG DAILY ORAL Abilify /Usa/ SS ORAL 15 MG DAILY ORAL Abilify /Usa/ SS ORAL 20 MG DAILY ORAL 20 DAY Gabitril /Sch/ SS ORAL 12 MG DAILY ORAL Klonopin SS ORAL 0.5 MG DAILY ORAL Ativan SS ORAL 0.5 MG DAILY ORAL Ativan SS ORAL 1 MG DAILY ORAL Date:09/28/04ISR Number: 4461053-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12704011 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:09/28/04ISR Number: 4461055-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12709333 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Abilify PS Otsuka Premature Baby Pharmaceutical Company, Ltd. ORAL Date of initiation not reported. Increased to 20 mg on Ambien SS ORAL Ativan SS ORAL Titrated up to 1 mg qid Effexor Xr SS ORAL Gabitril SS ORAL 4 mg in the 22-Feb-2006 08:31 AM Page: 579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report morning and 8 mg at hs. Klonopin SS ORAL Remeron SS ORAL Increased to 60 mg daily on 23-Feb-2004. Date:09/28/04ISR Number: 4461164-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12710182 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Abilify PS Otsuka Congenital Ectopic Pharmaceutical Bladder Company, Ltd. TRANSPLACENTAL Increased to Meningomyelocele 20 mg on 10-Dec-2003 and discontinued Ambien SS TRANSPLACENTAL Ativan SS TRANSPLACENTAL Dose titrated upward during pregnancy to 1 mg four times daily. Effexor Xr SS TRANSPLACENTAL Gabitril SS TRANSPLACENTAL 4 mg daily in the morning and 8 mg daily at hs. Klonopin SS TRANSPLACENTAL Remeron SS TRANSPLACENTAL Increased to 60 mg daily at hs on 23-Feb-2004. Date:09/28/04ISR Number: 4461348-8Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12668893 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Aripiprazole PS Otsuka Initial or Prolonged Drug Ineffective Pharmaceutical Hallucination Company, Ltd. ORAL 15mg Schizophrenia 27-Feb-04 to 21-Apr-04, 20mg 22-Apr-04 to Olanzapine C Lorazepam C 10-Mar-2004 to 20-Apr-2004 and 06-Aug-2004 22-Feb-2006 08:31 AM Page: 580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/04ISR Number: 4461351-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12705497 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Abilify PS Otsuka Depersonalisation Pharmaceutical Disorientation Company, Ltd. ORAL Motor Dysfunction Effexor C Vertigo Date:09/28/04ISR Number: 4461358-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12649356 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Abilify PS Otsuka Hospitalization - Heart Rate Irregular Pharmaceutical Initial or Prolonged Palpitations Company, Ltd. ORAL Supraventricular Cipramil C ORAL Tachycardia Arthrotec C ORAL Clopixol C INTRAMUSCULAR Kemadrin C ORAL Date:09/28/04ISR Number: 4461359-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12626081 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dry Skin Abilify PS Otsuka Erythema Pharmaceutical Face Oedema Company, Ltd. ORAL Flushing Calcichew D3 C Pruritus Evening Primrose Oil C Diazepam C Procyclidine C Venlafaxine Hcl C Risperidone C Olanzapine C Clozapine C Date:09/28/04ISR Number: 4461360-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12707352 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Abilify PS Otsuka Joint Stiffness Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL Temazepam C ORAL Date:09/28/04ISR Number: 4462195-3Report Type:Expedited (15-DaCompany Report #2004S1002336 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75MG, QD, Other ORAL Clozapine Tabelts 100mg Mylan SS ORAL 400MG HS, ORAL Cogentin SS Bristol-Myers Squibb 22-Feb-2006 08:31 AM Page: 581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS Bristol-Myers Squibb Simvastatin C Aripiprazole C Levothyroxine C Benztropine C Date:09/29/04ISR Number: 4461729-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12706693 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tic Health Aripiprazole PS Otsuka Tourette'S Disorder Professional Pharmaceutical Company, Ltd. ORAL Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. ORAL Lamotrigine C ORAL Date:09/29/04ISR Number: 4462027-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12707410 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Health Aripiprazole PS Otsuka Prescribed Overdose Professional Pharmaceutical Vomiting Company, Ltd. ORAL Humalog C SUBCUTANEOUS Metformine C ORAL Moxonidine C ORAL 400 MCG Haloperidol C ORAL Atenolol C Geneva Pharmaceuticals Technology, Corp. ORAL Date:09/29/04ISR Number: 4465283-0Report Type:Expedited (15-DaCompany Report #2004-120361-NL Age:0 DY Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Caesarean Section Health Remeron PS ORAL 45 MG DAILY Congenital Ectopic Professional ORAL Bladder Remeron SS ORAL 60 MG DAILY Drug Exposure During ORAL Pregnancy Ambien SS ORAL 20 MG DAILY Meningomyelocele ORAL Pregnancy Effexor-Xr SS ORAL 450 MG DAILY Premature Baby ORAL Abilify SS ORAL 15 MG DAILY ORAL Abilify SS ORAL 20 MG DAILY ORAL 20 DAY Gabitril SS ORAL 12 MG DAILY ORAL Klonopin SS ORAL 0.5 MG DAILY ORAL Ativan SS ORAL 0.5 MG DAILY ORAL Ativan SS ORAL 1 MG DAILY ORAL 22-Feb-2006 08:31 AM Page: 582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/04ISR Number: 4463311-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12707022 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. 15 mg/day, increased to 30 mg/day; then stopped, then 15 Quetiapine C Divalproex Sodium C Date:09/30/04ISR Number: 4463313-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12655866 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL 15mg 03-Oct-03 to 19-Mar-04,20m g 20-Mar-04 to 29-Jun-04, Date:09/30/04ISR Number: 4463315-7Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12653333 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Abilify PS Otsuka Increased Professional Pharmaceutical Aspartate Company, Ltd. Aminotransferase Diazepam C Increased Blood Alkaline Phosphatase Increased Blood Creatine Phosphokinase Increased Cholinergic Syndrome Extrapyramidal Disorder Leukocytosis Date:10/01/04ISR Number: 4463960-9Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12713749 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Aripiprazole PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Sertraline Hcl C Lorazepam C Omeprazole C 22-Feb-2006 08:31 AM Page: 583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/04ISR Number: 4478455-6Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12692117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Abilify Tabs 10 Mg PS Otsuka Drug Withdrawal Syndrome Professional Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Muscle Strain Zyprexa SS ORAL Nausea Fluctine C ORAL Date:10/04/04ISR Number: 4465085-5Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12709887 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Dizziness Company, Ltd. ORAL Headache Valproic Acid C Insomnia Amisulpride C increased to Nausea 800 mg and stopped in a tapering manner on Trimipramine C Levothyroxine C Dose = 100 ug Date:10/04/04ISR Number: 4465086-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12709507 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Artery Embolism Abilify PS Otsuka Hospitalization - Neuroleptic Malignant Pharmaceutical Initial or Prolonged Syndrome Company, Ltd. ORAL Initiated at 15 mg/day, increased to 30 mg/day in 2nd week of Date:10/04/04ISR Number: 4465144-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12683694 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Abilify PS Otsuka Other Cardiomegaly Pharmaceutical Mental Status Changes Company, Ltd. 5 mg/day x 4 Muscle Rigidity days, then 10 Tuberous Sclerosis mg/day x 4 days, then 15 mg/day for 30 Celebrex C Haldol C Evening Keppra C Lipitor C Zoloft C Ambien C Folic Acid C Geodon C Loperamide C Tussin Cf Cough C 22-Feb-2006 08:31 AM Page: 584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Saline C NASAL Colace C Phenytoin C Carbamazepine C Date:10/04/04ISR Number: 4465146-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12683694 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Abilify PS Otsuka Other Cardiomegaly Pharmaceutical Mental Status Changes Company, Ltd. 5 mg/day x 4 Muscle Rigidity days, then 10 Tuberous Sclerosis mg/day x 4 days, then 15 mg/day for 30 Celebrex C Haldol C Evening Keppra C Lipitor C Zoloft C Ambien C Folic Acid C Geodon C Loperamide C Tussin Cf Cough C Saline C NASAL Colace C Phenytoin C Carbamazepine C Date:10/04/04ISR Number: 4465306-9Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12709945 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Abilify PS Otsuka Hospitalization - Aspiration Pharmaceutical Initial or Prolonged Death Company, Ltd. Other Schizophrenia Prazine C Date:10/04/04ISR Number: 4465448-8Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12711735 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Trimipramine C Date:10/04/04ISR Number: 4467378-4Report Type:Expedited (15-DaCompany Report #2004-120361-NL Age:0 DY Gender:Male I/FU:F Outcome PT Congenital Anomaly Caesarean Section Colostomy Congenital Anomaly Congenital Ectopic 22-Feb-2006 08:31 AM Page: 585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bladder Congenital Spinal Cord Anomaly Drug Exposure During Report Source Product Role Manufacturer Route Dose Duration Pregnancy Health Remeron PS ORAL 45 MG DAILY Gastrointestinal Disorder Professional ORAL Congenital Remeron SS ORAL 60 MG DAILY Meningocele ORAL Premature Baby Ambien SS ORAL 20 MG DAILY ORAL Effexor-Xr SS ORAL 450 MG DAILY ORAL Abilify SS ORAL 15 MG DAILY ORAL Abilify SS ORAL 20 MG DAILY ORAL Gabitril SS ORAL 12 MG DAILY ORAL Klonopin SS ORAL 0.5 MG DAILY ORAL Ativan SS ORAL 0.5 MG DAILY ORAL Ativan SS ORAL 1 MG DAILY ORAL Date:10/04/04ISR Number: 4467884-2Report Type:Direct Company Report #CTU 228723 E Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Discomfort Abilify PS ORAL 15 MG PO Intervention to Dysphagia Prevent Permanent Dystonia Impairment/Damage Jaw Disorder Musculoskeletal Stiffness Tremor Date:10/05/04ISR Number: 4469433-1Report Type:Direct Company Report #CTU 228854 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Initial or Prolonged Obstructive Airways Disorder Oesophageal Spasm Respiration Abnormal Date:10/05/04ISR Number: 4469758-XReport Type:Expedited (15-DaCompany Report #2004GB02251 Age:37 YR Gender:Male I/FU:I Outcome PT Required Blood Pressure Increased Intervention to Condition Aggravated Prevent Permanent Disorientation Impairment/Damage Dysarthria Hyperhidrosis Mobility Decreased Neuroleptic Malignant Syndrome Tachycardia 22-Feb-2006 08:31 AM Page: 586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Quetiapine PS UP TO 150 MG Health Abilify SS UP TO 20MG Professional Paracetamol C Other Procyclidine C Melatonin C Lithium C Movicol C Date:10/06/04ISR Number: 4466838-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12711669 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:10/07/04ISR Number: 4468166-5Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12678884 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Blood Bilirubin Increased Pharmaceutical Other Haemolysis Company, Ltd. Restlessness Diazepam SS Quetiapine C Initiated at 1600 mg/day tapered to 300 mg/day on 12-Aug-2004. Promethazine C Tenormin C Date:10/07/04ISR Number: 4468335-4Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12715587 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystectomy Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/day, increased to 30 mg/day on 14-Jul-2004. Antidepressant C Date:10/07/04ISR Number: 4468341-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12713533 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Abilify PS Otsuka Electrocardiogram St Professional Pharmaceutical Segment Depression Company, Ltd. ORAL Electrocardiogram T Wave Solian SS ORAL Inversion Tavor C 22-Feb-2006 08:31 AM Page: 587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4469217-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12716981 Age:9 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Abilify PS Otsuka Initial or Prolonged Urosepsis Pharmaceutical Other Company, Ltd. ORAL Date:10/08/04ISR Number: 4474222-8Report Type:Expedited (15-DaCompany Report #HQWYE480223AUG04 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Caesarean Section Health Effexor Xr Congenital Ectopic Professional (Venlafaxine Bladder Company Hydrochloride, Drug Exposure During Representative Capsule, PS TRANSPLACENTAL 450 MG 1X PER Pregnancy 1 DAY, Meningocele TRANSPLACENTA Multiple Congenital L Abnormalities Abilify Premature Baby (Aripiprazole, ) SS TRANSPLACENTAL SEE IMAGE, TRANSPLACENTA L Ambien (Zolpidem Tartrate, ) SS TRANSPLACENTAL 20 MG 1X PER 1 DAY, TRANSPLACENTA L Ativan (Lorazepam, Tablet) SS TRANSPLACENTAL SEE IMAGE, TRANSPLACENTA L Gabitril (Tiagabine Hydrochloride, ) SS TRANSPLACENTAL 12 MG 1X PER 1 DAY, TRANSPLACENTA L Klonopin (Clonazepam, ) SS TRANSPLACENTAL 2 MG 1X PER 1 DAY, TRANSPLACENTA L Remeron (Mirtazapine, ) SS TRANSPLACENTAL SEE IMAGE, TRANSPLACENTA L Date:10/11/04ISR Number: 4470837-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649778 Age:94 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Abilify PS Otsuka Initial or Prolonged Urosepsis Professional Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day. 2 WK Ativan C Nitro-Dur C Berocca Plus C Tylenol C 22-Feb-2006 08:31 AM Page: 588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/04ISR Number: 4470839-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12717070 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oesophageal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Strattera C Date:10/11/04ISR Number: 4470840-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12714622 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Increased Pharmaceutical Other Aspartate Company, Ltd. ORAL Aminotransferase Abilify Tabs 10 Mg SS Otsuka Increased Pharmaceutical Blood Creatine Company, Ltd. ORAL Phosphokinase Increased Klonopin C Catatonia Cogentin C Convulsion Depakote C Prescribed Overdose Date:10/11/04ISR Number: 4470841-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12651287 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Abilify PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day ended at 10 mg/day. 2 WK Cogentin C Colace C Lopressor C Os-Cal + D C Risperdal C Maxzide C Date:10/11/04ISR Number: 4471057-7Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12670543 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Abilify PS Otsuka Initial or Prolonged Chronic Obstructive Pharmaceutical Pulmonary Disease Company, Ltd. ORAL Hypertension Seroquel SS ORAL Nephrolithiasis Temesta C Pancreatitis Acute Cosaar C Norvasc C Nexium C Benerva C Becozym C Vioxx C Symbicort C 22-Feb-2006 08:31 AM Page: 589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/04ISR Number: 4471058-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12716288 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Parkinson'S Disease Abilify PS Otsuka Hospitalization - Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Disability Madopar C Other Ropinirole C Citalopram C Lorazepam C Thyroxine C Date:10/12/04ISR Number: 4471442-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12626081 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dry Skin Health Abilify PS Otsuka Erythema Professional Pharmaceutical Face Oedema Company, Ltd. ORAL Flushing Calcichew D3 C Pruritus Evening Primrose Oil C Diazepam C Procyclidine C Venlafaxine Hcl C Risperidone C Olanzapine C Clozapine C Date:10/12/04ISR Number: 4471477-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12718755 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Abilify PS Otsuka Initial or Prolonged Cognitive Disorder Pharmaceutical Company, Ltd. ORAL Date:10/12/04ISR Number: 4471751-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12718730 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Communication Disorder Abilify PS Otsuka Hospitalization - Dementia Pharmaceutical Initial or Prolonged Drug Ineffective Company, Ltd. ORAL Other Fall Feeding Disorder Gait Disturbance Nuchal Rigidity Restlessness Torticollis Date:10/12/04ISR Number: 4476093-2Report Type:Expedited (15-DaCompany Report #2004070951 Age:25 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Sertraline Other Drug Toxicity Health (Sertraline) PS Multiple Drug Overdose Professional Methamphetamine 22-Feb-2006 08:31 AM Page: 590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Methamphetamine) SS Aripiprazole (Aripiprazole) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:10/13/04ISR Number: 4472751-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12643490 Age:4 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Citalopram C Date:10/13/04ISR Number: 4473010-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12686150 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Abilify PS Otsuka Hospitalization - Phosphokinase Increased Pharmaceutical Initial or Prolonged Mobility Decreased Company, Ltd. ORAL Decreased to Other Muscle Rigidity 5 mg/day on Tremor 12-Aug-2004, then discontinued. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 5 mg/day on 12-Aug-2004, then discontinued. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 5 mg/day on 12-Aug-2004, then discontinued. Valproic Acid C Celexa C Date:10/13/04ISR Number: 4473324-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12601993 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose: 2.5 mg/day, inc to 15 mg/day, decreased on Olanzapine C Lithium C 22-Feb-2006 08:31 AM Page: 591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Date:10/14/04ISR Number: 4474509-9Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12720389 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Citalopram C Date:10/14/04ISR Number: 4475451-XReport Type:Direct Company Report #CTU 229608 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Failure Depakote 500 Mg Other Liver Transplant Three Qhs PS ORAL PO/HOSPITALIZ Required ED Intervention to Abiliify 10 Mg One Prevent Permanent Qhs SS ORAL PO Impairment/Damage Topamax 25 Mg Qid SS Dalmane 30 Mg One Qhs SS Date:10/15/04ISR Number: 4475477-6Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12670212 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Abilify PS Otsuka Completed Suicide Professional Pharmaceutical Psychotic Disorder Company, Ltd. ORAL Zyprexa C Solian C Temesta C Efexor C Date:10/15/04ISR Number: 4475479-XReport Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12693727 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL 15mg 07-Mar-04 to 11-Jul-04, 30mg 12-Jul-04 to Depakin C Rivotril C Date:10/15/04ISR Number: 4475704-5Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12713749 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Aripiprazole PS Otsuka Professional Pharmaceutical 22-Feb-2006 08:31 AM Page: 592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Sertraline Hcl C Lorazepam C Omeprazole C Date:10/15/04ISR Number: 4505034-4Report Type:Periodic Company Report #2003040738 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Depression Consumer Neurontin Mania (Gabapentin) PS Aripiprazole (Aripiprazole) SS Date:10/18/04ISR Number: 4477051-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623229 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Abilify Tabs 10 Mg PS Otsuka Diabetic Neuropathy Pharmaceutical Dysarthria Company, Ltd. ORAL 15 mg 1 Headache tablet daily Hemiparesis in the Joint Stiffness evenings Migraine taken in Muscular Weakness Avandia C Musculoskeletal Stiffness Atenolol C Geneva Visual Disturbance Pharmaceuticals Technology, Corp. Lipitor C Plendil C Date:10/18/04ISR Number: 4477054-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12721882 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hot Flush Abilify Tabs 15 Mg PS Otsuka Loss Of Consciousness Pharmaceutical Nausea Company, Ltd. ORAL Vomiting Zoloft C Minocycline C Date:10/18/04ISR Number: 4477063-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12721973 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Self-Injury Abilify PS Otsuka Hospitalization - Schizoaffective Disorder Pharmaceutical Initial or Prolonged Company, Ltd. 3 WK Lamotrigine C Solian C 22-Feb-2006 08:31 AM Page: 593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/04ISR Number: 4477065-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700696 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Abilify PS Otsuka Initial or Prolonged Pleural Effusion Professional Pharmaceutical Company, Ltd. ORAL Depakote SS Date:10/18/04ISR Number: 4477248-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12682092 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Abilify PS Otsuka Initial or Prolonged Intestinal Obstruction Professional Pharmaceutical Company, Ltd. ORAL Cogentin SS 4 YR Serzone SS Bristol-Myers Squibb Company 4 YR Clonazepam SS 4 YR Singulair C Levitra C Taken prior to sex Claritin D C Date:10/18/04ISR Number: 4477249-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12722914 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:10/19/04ISR Number: 4478415-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12726261 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Aripiprazole PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Date:10/19/04ISR Number: 4478776-7Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12726238 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Impulsive Behaviour Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:10/19/04ISR Number: 4483493-3Report Type:Direct Company Report #CTU 230014 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Aripiprazole 15 Mg PS ORAL 15MG HS Tremor ORAL Lisinopril C Lovastatin C 22-Feb-2006 08:31 AM Page: 594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metoprolol C Olanzapine C Lithium C Lorazepam C Date:10/20/04ISR Number: 4479531-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12726014 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL Date:10/20/04ISR Number: 4479533-8Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12726212 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL 15mg 17-Aug-04 to 30-Aug-04, 30mg 31-Aug-04 to Promethazine Hcl C Biperiden Hcl C Nitrazepam C Date:10/20/04ISR Number: 4479600-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12623229 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Abilify Tabs 10 Mg PS Otsuka Diabetic Neuropathy Pharmaceutical Dysarthria Company, Ltd. ORAL 15 mg 1 Headache tablet daily Hemiparesis in the Joint Stiffness evenings Migraine taken in Muscular Weakness Avandia C Musculoskeletal Stiffness Atenolol C Geneva Visual Disturbance Pharmaceuticals Technology, Corp. Lipitor C Plendil C Date:10/20/04ISR Number: 4479604-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12725800 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Discomfort Abilify PS Otsuka Defaecation Urgency Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Trismus 22-Feb-2006 08:31 AM Page: 595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/04ISR Number: 4483577-XReport Type:Direct Company Report #CTU 230184 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Aripiprazole PS Fluticasone Prop C Loratadine C Date:10/22/04ISR Number: 4482038-1Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12731931 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initiated at 30 mg/day, decreased to 15 mg/day on 24-Sep-2004 Promethazine C Date:10/22/04ISR Number: 4482172-6Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12731980 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Abilify PS Otsuka Initial or Prolonged Anxiety Pharmaceutical Decreased Appetite Company, Ltd. ORAL Initiated on Enuresis 31-Aug-2004 Fluid Intake Reduced at 15 mg/day, Psychotic Disorder increased to 30 mg/day Clopixol C Taken for years Akineton Retard C Taken for years Nozinan C Taken for years Date:10/25/04ISR Number: 4483942-0Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12668893 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Aripiprazole PS Otsuka Initial or Prolonged Hallucination Pharmaceutical Schizophrenia Company, Ltd. ORAL 15mg 27-Feb-04 to 21-Apr-04, 20mg 22-Apr-04 to Olanzapine C Lorazepam C 10-Mar-2004 to 20-Apr-2004 and 06-Aug-2004 22-Feb-2006 08:31 AM Page: 596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/04ISR Number: 4487887-1Report Type:Expedited (15-DaCompany Report #DSA_24883_2004 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Health Ativan PS TRANSPLACENTAL 0.5 MG QID Initial or Prolonged Congenital Ectopic Professional TRAN-P Congenital Anomaly Bladder Ativan SS TRANSPLACENTAL 1 MG QID, Required Drug Exposure During TRAN-P Intervention to Pregnancy Effexor-Xr SS TRANSPLACENTAL 450 MG QD Prevent Permanent Meningomyelocele TRAN-P Impairment/Damage Premature Baby Abilify SS TRANSPLACENTAL 20 MG QHS, TRAN-P Abilify SS TRANSPLACENTAL 15 MG QD TRAN-P Ambien SS TRANSPLACENTAL 20 MG QD TRAN-P Gabitril SS TRANSPLACENTAL 12 MG QD, TRAN-P Klonopin SS TRANSPLACENTAL 2 MG TRAN-P Remeron SS TRANSPLACENTAL 45 MG QD TRAN-P Remeron SS TRANSPLACENTAL 60 MG QHS, TRAN-P Date:10/25/04ISR Number: 4487893-7Report Type:Expedited (15-DaCompany Report #DSA_24882_2004 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Health Ativan PS 0.5 MG QID Initial or Prolonged Drug Exposure During Professional Ativan SS 1 MG QID Congenital Anomaly Pregnancy Effexor-Xr SS 450 MG QD Required Electroconvulsive Therapy Remeron/Net/ SS 45 MG QD Intervention to Pregnancy Remeron/Net/ SS 60 MG QHS Prevent Permanent Premature Labour Abilify SS 15 MG QD Impairment/Damage Abilify SS 20 MG QHS Ambien SS 20 MG QD Gabitril SS 12 MG QD Klonopin SS 2 MG QD Date:10/26/04ISR Number: 4485446-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731949 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Abilify PS Otsuka Nausea Professional Pharmaceutical Prescribed Overdose Company, Ltd. ORAL Two tablets Splenic Infarction in the morning and one tablet in the evening. Buspirone Hcl Tabs 15 Mg SS Bristol-Myers Squibb Company ORAL Clonazepam C Clozaril C Darvocet-N C Dulcolax C Florinef C King Pharmaceutical Inc. Imodium C 22-Feb-2006 08:31 AM Page: 597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Provigil C Tylenol C Zelnorm C Date:10/26/04ISR Number: 4485452-3Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12570966 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Lorazepam C Atenolol C Geneva Pharmaceuticals Technology, Corp. Date:10/26/04ISR Number: 4485453-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731626 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biliary Dilatation Abilify PS Otsuka Blood Alkaline Pharmaceutical Phosphatase Increased Company, Ltd. ORAL Initiated 5 Blood Bilirubin Increased mg/day Lipase Increased 19-Apr-2004. Nausea Inc to 20 Vomiting mg/day, then Benadryl C Date:10/27/04ISR Number: 4486494-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12733184 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day for 2-3 weeks, then increased to Date:10/27/04ISR Number: 4486534-2Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12705497 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Health Abilify PS Otsuka Disorientation Professional Pharmaceutical Hypoaesthesia Company, Ltd. ORAL Motor Dysfunction Effexor C Sensory Disturbance Sleep Disorder Vertigo 22-Feb-2006 08:31 AM Page: 598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/04ISR Number: 4486812-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12733887 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:10/27/04ISR Number: 4487626-4Report Type:Direct Company Report #CTU 230631 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Aripiprazole 15mg PS ORAL 15 MG QAM Initial or Prolonged Psychotic Disorder ORAL Treatment Noncompliance Date:10/28/04ISR Number: 4488035-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12737656 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Fear Abilify PS Otsuka Insomnia Pharmaceutical Muscle Twitching Company, Ltd. ORAL Psychiatric Symptom Fluoxetine C ORAL Psychomotor Hyperactivity Date:10/28/04ISR Number: 4488148-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741450 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Aripiprazole PS Otsuka Professional Pharmaceutical Company, Ltd. ORAL Paroxetine SS ORAL Olanzapine SS ORAL Date:10/28/04ISR Number: 4488172-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741617 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Aripiprazole PS Otsuka Drug Toxicity Professional Pharmaceutical Company, Ltd. ORAL Methamphetamine Hcl SS ORAL Sertraline SS ORAL Date:10/28/04ISR Number: 4490100-2Report Type:Expedited (15-DaCompany Report #2004UW21718 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Seroquel PS ORAL 450 MG DAILY Initial or Prolonged Headache PO Heart Rate Increased Seroquel SS ORAL 800 MG DAILY Muscle Rigidity PO 1 MON Schizophrenia Seroquel SS ORAL 1000 MG DAILY PO Prolixin SS 3 DAY 22-Feb-2006 08:31 AM Page: 599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS 5 DAY Risperdal C Haldol C Zyprexa C Date:10/28/04ISR Number: 4491274-XReport Type:Expedited (15-DaCompany Report #2004PK01743 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS 400 TO 800 MG Initial or Prolonged Neutropenia Health Seroquel SS ORAL 400 MG DAILY Professional PO Other Leponex SS 200 TO 300 MG Leponex SS 100 TO 150 MG Leponex SS ORAL 75 MG DAILY PO Leponex SS ORAL 50 MG DAILY PO Leponex SS ORAL 25 MG DAILY PO Leponex SS ORAL 0 MG DAILY PO Leponex SS ORAL 12.5 MG DAILY PO Abilify SS ORAL 7.5 MG DAILY PO Abilify SS ORAL 15 MG DAILY PO Abilify SS ORAL 22.5 MG DAILY PO Abilify SS ORAL 30 MG DAILY PO Abilify SS ORAL 30.75 MG DAILY PO Abilify SS ORAL 0 MG DAILY PO Abilify SS ORAL 15 MG DAILY PO Abilify SS ORAL 30 MG DAILY PO Abilify SS ORAL 37.5 MG DAILY PO Madopar SS ORAL 62.5 MG DAILY PO Madopar SS ORAL 125 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 250 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 125 MG DAILY PO Madopar SS ORAL 67.5 MG DAILY PO Madopar SS ORAL 0 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 250 MG DAILY PO Sinemet-Cr SS 200 DAILY 22-Feb-2006 08:31 AM Page: 600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinemet-Cr SS 400 DAILY Sinemet-Cr SS 600 DAILY Date:10/29/04ISR Number: 4488944-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12737524 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:10/29/04ISR Number: 4488946-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12736500 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Abilify PS Otsuka Initial or Prolonged Communication Disorder Pharmaceutical Tremor Company, Ltd. ORAL Metoprolol C ORAL Metformin Hcl C Bristol-Myers Squibb Company ORAL Isosorbide Mononitrate C Date:10/29/04ISR Number: 4488949-5Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12744777 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify PS Otsuka Headache Pharmaceutical Loss Of Consciousness Company, Ltd. ORAL Syncope Ziprasidone C ORAL Date:10/29/04ISR Number: 4491974-1Report Type:Direct Company Report #CTU 230773 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Geodon PS SEE IMAGE Suicidal Ideation Abilify SS ORAL 10 MG, PO, QAM Date:11/01/04ISR Number: 4489459-1Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12713749 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Sertraline C ORAL Lorazepam C ORAL Omeprazol C ORAL 22-Feb-2006 08:31 AM Page: 601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4490475-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12676730 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Escherichia Urinary Tract Pharmaceutical Infection Company, Ltd. ORAL Neuroleptic Malignant Abilify SS Otsuka Syndrome Pharmaceutical Urinary Tract Infection Company, Ltd. ORAL Atorvastatin C ORAL Nicorandil C ORAL Co-Amilofruse C ORAL 2.5/20 mg Lorazepam C ORAL Sertraline C ORAL Sodium Valproate C ORAL Celecoxib C ORAL Thyroxine C ORAL Lansoprazole C ORAL Date:11/02/04ISR Number: 4490476-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12739462 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Hospitalization - Diabetic Ketoacidosis Pharmaceutical Initial or Prolonged Sepsis Company, Ltd. Date:11/02/04ISR Number: 4492704-XReport Type:Direct Company Report #CTU 231057 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradykinesia Aripiprazole 10 Mg PS ORAL 10 MG QD ORAL Dysgraphia Valproic Acid C Tremor Date:11/02/04ISR Number: 4492847-0Report Type:Direct Company Report #CTU 231054 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Aripiprazole 30 Mg PS ORAL 30 MG QD ORAL Phosphokinase Increased Diphenhydramine C Fluphenazine C Ranitidine C Lorazepam C Escitalopram C Date:11/03/04ISR Number: 4491524-XReport Type:Expedited (15-DaCompany Report #GR-BRISTOL-MYERS SQUIBB COMPANY-12740593 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Daflon C 500 mg, 1x3 Loftyl C 600 mg, 1x2 Vastarel C 20 mg, 1x3 Salospir C 100 mg, 1x1 22-Feb-2006 08:31 AM Page: 602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamins C 1x2 Date:11/04/04ISR Number: 4492626-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12744769 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/04/04ISR Number: 4493134-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12745121 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysfunctional Uterine Abilify PS Otsuka Bleeding Pharmaceutical Ovarian Cyst Company, Ltd. Date:11/04/04ISR Number: 4494220-8Report Type:Direct Company Report #CTU 231311 E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Aripiprazole 15 Mg Initial or Prolonged Condition Aggravated Abilify (R) By Other Psychotic Disorder Otsuka Treatment Noncompliance Pharmaceuticals PS Otsuka Pharmaceuticals ORAL 15 MG QAM ORAL Date:11/05/04ISR Number: 4493863-5Report Type:Expedited (15-DaCompany Report #BR-BRISTOL-MYERS SQUIBB COMPANY-12745675 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/05/04ISR Number: 4495162-4Report Type:Direct Company Report #CTU 231391 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Abilify 30 Mg PS ORAL 30 MG PO QD 1 WK Date:11/08/04ISR Number: 4495363-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12710901 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Abilify PS Otsuka Initial or Prolonged Splenic Injury Pharmaceutical Company, Ltd. ORAL 21-Sep-04 reduced to 10 mg 2 x day for 2 days; 23-Sep-04 10 Ativan C 22-Feb-2006 08:31 AM Page: 603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Date:11/09/04ISR Number: 4496723-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12474573 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laceration Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Self-Injurious Ideation Company, Ltd. ORAL 15 mg Therapeutic Response 05-Dec-03 to Decreased 05-Jan-04; then 30 mg 06-Jan-04 to Zopiclone C Sertraline C Diazepam C Date:11/10/04ISR Number: 4497814-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749180 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Agent Blinded: Toxicity Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Blinded: Lithium SS ORAL Blinded: Placebo SS ORAL 300 or 15 mg Lipitor C Clonidine C Lotensin C Date:11/10/04ISR Number: 4501409-8Report Type:Expedited (15-DaCompany Report #2004UW21718 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Consumer Seroquel PS ORAL 450 MG DAILY Initial or Prolonged Drug Ineffective PO Dysuria Seroquel SS ORAL 800 MG DAILY Headache PO 1 MON Heart Rate Increased Seroquel SS ORAL 1000 MG DAILY Joint Stiffness PO Schizophrenia Seroquel SS ORAL 1100 MG DAILY Tongue Disorder PO Prolixin SS 3 DAY Abilify SS 5 DAY Risperdal C Haldol C Zyprexa C Date:11/12/04ISR Number: 4499700-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12718730 Age:82 YR Gender:Female I/FU:F Outcome PT Death Communication Disorder Hospitalization - Dementia Initial or Prolonged Drug Ineffective Other Fall 22-Feb-2006 08:31 AM Page: 604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeding Disorder Gait Disturbance Nuchal Rigidity Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify Tabs PS Otsuka Torticollis Pharmaceutical Company, Ltd. ORAL Date:11/12/04ISR Number: 4499790-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12733184 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Health Abilify PS Otsuka Pulmonary Embolism Professional Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day on 03-Sep-04 then increased to Date:11/12/04ISR Number: 4499792-5Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12713533 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Abilify PS Otsuka Chest Pain Professional Pharmaceutical Electrocardiogram St Company, Ltd. ORAL Segment Depression Solian SS ORAL Electrocardiogram T Wave Tavor C Inversion Date:11/15/04ISR Number: 4500618-1Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12753042 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify Tabs 15 Mg PS Otsuka Hypotension Pharmaceutical Company, Ltd. ORAL Buspirone C Lamictal C Olanzapine C Centrum C Droperidol I INTRAMUSCULAR Date:11/15/04ISR Number: 4500620-XReport Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12753075 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Abilify PS Otsuka Initial or Prolonged Consciousness Pharmaceutical Drug Interaction Company, Ltd. ORAL Levlen C Mylanta C Seroquel I Midazolam I INTRAMUSCULAR Droperidol I INTRAMUSCULAR Lamictal I ORAL Diazepam I ORAL 22-Feb-2006 08:31 AM Page: 605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Epilim I ORAL Date:11/15/04ISR Number: 4501053-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12548293 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL Date:11/15/04ISR Number: 4501055-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12649737 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Health Abilify PS Otsuka Initial or Prolonged Pregnancy Professional Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg on 12-Dec-03; inc to 15mg on 18-Feb-04. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day, inc to 10 mg on 12-Dec-03; inc to 15mg on 18-Feb-04. Trazodone Hcl C Apothecon ORAL 100-200 mg at bedtime 6 YR Prenatal Vitamin C Glucophage C Bristol-Myers Squibb Company Clonazepam C Date:11/15/04ISR Number: 4504045-2Report Type:Expedited (15-DaCompany Report #04-08-1210 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Ivax Other Delusion Professional Pharmaceuticals, Drug Level Increased Other Inc. Tablets PS ORAL 350 QD ORAL Paranoia Abilify SS 30 MG QD Treatment Noncompliance Lexapro C Klonopin C Date:11/16/04ISR Number: 4501992-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12435814 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Aripiprazole PS Otsuka Hospitalization - Neuroleptic Malignant Pharmaceutical Initial or Prolonged Syndrome Company, Ltd. ORAL Initial dose Tachycardia 15 mg/day. Efexor C ORAL 150 mg/day to 225 mg/day 22-Feb-2006 08:31 AM Page: 606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/04ISR Number: 4501998-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12759445 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervous System Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/16/04ISR Number: 4504150-0Report Type:Direct Company Report #CTU 232094 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Aripiprazole PS Date:11/17/04ISR Number: 4502825-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041102372 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Risperdal Consta PS INTRAMUSCULAR 43 DAY Initial or Prolonged Amisulpride SS Aripiprazole SS Date:11/17/04ISR Number: 4503335-7Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12709945 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Abilify PS Otsuka Hospitalization - Aspiration Professional Pharmaceutical Initial or Prolonged Pulmonary Embolism Company, Ltd. Other Schizophrenia Prazine C Flupentixol C Date:11/18/04ISR Number: 4504290-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12655866 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Aripiprazole PS Otsuka Initial or Prolonged Professional Pharmaceutical Company, Ltd. ORAL 15mg 03-Oct-03 to 19-Mar-04,20m g 20-Mar-04 to 29-Jun-04, Date:11/18/04ISR Number: 4505178-7Report Type:Direct Company Report #CTU 232392 E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Abilify 15mg Dyspnoea Bristol Myers Squibb PS Bristol Myers Squibb ORAL 1TAB EVERY Fluid Retention DAY ORAL Oedema Peripheral Crestor C Pitting Oedema Lisinopril C Weight Increased Glucophage C Norvasc C 22-Feb-2006 08:31 AM Page: 607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/04ISR Number: 4505463-9Report Type:Direct Company Report #CTU 232419 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Fluctuation Aripirazole PS ORAL 10MG DAILY Chest Pain ORAL Diabetes Mellitus Lasix C Inadequate Control Lisinopril C Heart Rate Increased Digoxin C Ecotrin C Imdur C Protonix C Catapres Tts C Glipizide C Date:11/18/04ISR Number: 4507393-5Report Type:Expedited (15-DaCompany Report #2004070951 Age:25 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Sertraline Other Multiple Drug Overdose Health (Sertraline) PS Professional Methamphetamine (Methamphetamine) SS Aripiprazole (Aripiprazole) SS Date:11/22/04ISR Number: 4506540-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12722914 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Abilify PS Otsuka Other Grand Mal Convulsion Pharmaceutical Myocardial Infarction Company, Ltd. ORAL Pulse Absent Ramipril C ORAL Treatment Noncompliance Lipitor C ORAL Urinary Incontinence Spironolactone C ORAL Omega-3 C ORAL Aspirin C ORAL Ikorel C ORAL Elantan C ORAL Lorazepam C ORAL Date:11/22/04ISR Number: 4506564-1Report Type:Expedited (15-DaCompany Report #AT-BRISTOL-MYERS SQUIBB COMPANY-12759254 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Homicidal Ideation Pharmaceutical Company, Ltd. ORAL 15 mg to 15-Aug-2004/i nc. 30 mg 16-Aug-2004-2 4-Aug-2004/de Biperiden C ORAL Clonazepam C ORAL initiated 12-Aug-2004 1.5 mg/inc. to 3 mg 13-Aug-2004/d 22-Feb-2006 08:31 AM Page: 608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozapine C ORAL 500 mg til 23-Aug-2004/6 00 mg 24-Aug-2004/8 00 mg Lorazepam C ORAL Oxazepam C ORAL 250 mg 16-Aug-2004 to 17-Aug-2004/5 0 mg Risperidone C ORAL 4 mg 10-Aug-2004 to 11-Aug-2004/2 mg 12-Aug/4 Valproic Acid C ORAL till 15-Aug-2004/1 500 mg 16-Aug-2004 to Date:11/22/04ISR Number: 4506567-7Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12758843 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Myositis Company, Ltd. ORAL Date:11/22/04ISR Number: 4506615-4Report Type:Expedited (15-DaCompany Report #GR-BRISTOL-MYERS SQUIBB COMPANY-12740593 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Iron Decreased Abilify PS Otsuka Blood Triglycerides Pharmaceutical Increased Company, Ltd. ORAL Blood Urea Increased Daflon C 500 mg, 1x3 Bundle Branch Block Right Loftyl C 600 mg, 1x2 Cardiac Arrest Vastarel C 20 mg, 1x3 Electrocardiogram Salospir C 100 mg, 1x1 Repolarisation Multivitamins C 1x2 Abnormality Haematocrit Decreased Haemoglobin Decreased Mean Cell Haemoglobin Decreased Mean Cell Volume Decreased Sudden Cardiac Death Ventricular Hypertrophy Date:11/22/04ISR Number: 4511202-8Report Type:Direct Company Report #CTU 232756E Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS ORAL 5 MG 1 A DAY Initial or Prolonged ORAL 22-Feb-2006 08:31 AM Page: 609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/04ISR Number: 4507778-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12763652 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Abilify PS Otsuka Therapeutic Pharmaceutical Malaise Company, Ltd. ORAL 1 MON Nausea Atazanavir C Bristol-Myers Squibb Company 6 MON Date:11/23/04ISR Number: 4507800-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749180 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Blinded: Initial or Prolonged Renal Failure Aripiprazole PS Otsuka Other Therapeutic Agent Pharmaceutical Toxicity Company, Ltd. ORAL 15 to 30 mg Blinded: Lithium SS ORAL 900 to 1200 mg Blinded: Placebo SS ORAL 300 or 15 mg Clonidine SS ORAL Lipitor C ORAL Lotensin C ORAL Seroquel C ORAL Folic Acid C ORAL Aspirin C ORAL Lorazepam C ORAL 1mg 18-Oct-04 to 20-Oct-04 and on 23-Oct-04, 2mg 25-Oct-04 Date:11/23/04ISR Number: 4507804-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12722476 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Erosive Oesophagitis Abilify PS Otsuka Pharmaceutical Company, Ltd. 7.5 mg from 14-Jan, 15 mg from 20-Jan, 10 mg from 02-Feb, 5 mg 56 DAY Zyprexa C Lexapro C Clonazepam C Wellbutrin Xl C Date:11/23/04ISR Number: 4508874-0Report Type:Expedited (15-DaCompany Report #BR-BRISTOL-MYERS SQUIBB COMPANY-12745675 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Victim Of Homicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/04ISR Number: 4508875-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12766093 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Abilify PS Otsuka Other Death Pharmaceutical Pneumonia Company, Ltd. Date:11/23/04ISR Number: 4509012-0Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12766234 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Clonus Company, Ltd. Hyperreflexia Fluoxetine C Hypertension Zyprexa C ORAL Hypertonia Serotonin Syndrome Somnolence Tremor Date:11/24/04ISR Number: 4509644-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12739462 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Hospitalization - Diabetic Ketoacidosis Pharmaceutical Initial or Prolonged Gynaecomastia Company, Ltd. ORAL 8 MON Infection Ritalin C Polyuria Sepsis Treatment Noncompliance Vomiting Date:11/24/04ISR Number: 4509875-9Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12768024 Age:3 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Abilify PS Otsuka Heart Disease Congenital Pharmaceutical Kidney Malformation Company, Ltd. ORAL Dosing to be Limb Malformation confirmed. Pregnancy Effexor Xr C Date:11/24/04ISR Number: 4509876-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12721973 Age:40 YR Gender:Female I/FU:F Outcome PT Life-Threatening Aggression Hospitalization - Cognitive Disorder Initial or Prolonged Condition Aggravated Hallucinations, Mixed Intentional Self-Injury Major Depression Memory Impairment Restlessness Schizoaffective Disorder 22-Feb-2006 08:31 AM Page: 611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Thermal Burn Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lamotrigine C ORAL Inc on 19-Aug-2004 to 50 mg in morning and 75 mg in the Solian C Haldol C ORAL Increased to 5 mg 4 times daily, then discontinued on Diazepam C ORAL Inc to 10 mg 4 times daily Date:11/24/04ISR Number: 4510141-6Report Type:Expedited (15-DaCompany Report #DK-BRISTOL-MYERS SQUIBB COMPANY-12766739 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Abilify PS Otsuka Hospitalization - Paralysis Pharmaceutical Initial or Prolonged Suicide Attempt Company, Ltd. ORAL Initiated 2-3 Disability weeks prior to the event. Date:11/29/04ISR Number: 4511302-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768032 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Abilify PS Otsuka Hospitalization - Fluctuation Pharmaceutical Initial or Prolonged Confusional State Company, Ltd. ORAL Disability Heart Rate Irregular Effexor Xr C Other Hyperhidrosis Cipramil C Hyperpyrexia Atorvastatin C Hypertonia Premique C Neuroleptic Malignant Movicol C Syndrome Clonazepam C Diazepam C Calogen C Fresubin C Date:11/29/04ISR Number: 4511376-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12768891 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Health Abilify PS Otsuka Haemorrhage Professional Pharmaceutical Overdose Company, Ltd. Suicide Attempt Abilify SS Otsuka Pharmaceutical Company, Ltd. Trazodone Hcl SS Apothecon 22-Feb-2006 08:31 AM Page: 612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ssri SS Date:11/29/04ISR Number: 4511393-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12454880 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs 10 Mg PS Otsuka Aspartate Pharmaceutical Aminotransferase Company, Ltd. ORAL Started on 5 Increased mg/day Back Pain Abilify Tabs 10 Mg SS Otsuka Blepharospasm Pharmaceutical Blood Creatine Company, Ltd. ORAL Started on 5 Phosphokinase Increased mg/day Headache Prozac C 20 mg two Muscle Spasms times every day 2 YR Yasmin C Date:11/29/04ISR Number: 4511395-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12481511 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Abilify PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Advair C Flovent C Prednisone C Singulair C Guaifenesin C Clarinex C Estradiol C Apothecon Medroxyprogesterone C Levoxyl C Neurontin C Soma C Furosemide C Potassium Chloride C Geneva Pharmaceuticals, Inc. (Novartis) Naproxen C Date:11/29/04ISR Number: 4511396-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12550935 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Suicidal Ideation Pharmaceutical Tardive Dyskinesia Company, Ltd. ORAL Init at 10 Torticollis mg/day "several months" ago;incr to 22-Feb-2006 08:31 AM Page: 613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Init at 10 mg/day "several months" ago;incr to Remeron C Tegretol C Klonopin C Date:11/29/04ISR Number: 4511397-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12580155 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Prenatal Vitamins C Date:11/29/04ISR Number: 4511398-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12606661 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Reduced to 15 mg/day on 04-Jun-2004 Date:11/29/04ISR Number: 4511399-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608246 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Lamictal C Topamax C Date:11/29/04ISR Number: 4511400-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12608253 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL increased to 10 mg 28-Apr-04; then discontinued 2 MON 22-Feb-2006 08:31 AM Page: 614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C SYRUP 1 TSP PRN Albuterol Inhaler C 2 PUFFS PRN Date:11/29/04ISR Number: 4511401-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12619201 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS Otsuka Initial or Prolonged Cerebrovascular Accident Pharmaceutical Other Depression Company, Ltd. ORAL Jun-2003 Heart Rate Decreased (dose unknown); increased to 30mg Depakote C Monopril C Bristol-Myers Squibb Company Lexapro C Date:11/29/04ISR Number: 4511402-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12622650 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Increased Abilify PS Otsuka White Blood Cell Count Pharmaceutical Increased Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Topamax C Date:11/29/04ISR Number: 4511403-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12636924 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg qd started 30-Jan-04 Geodon C taper completed 03-Aug-04 Zoloft C ORAL Clonazepam C 0.5 mg BID and 2 mg every night (qhs) Vitamin E C Vitamin B6 C Lithium C ORAL qhs 22-Feb-2006 08:31 AM Page: 615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511404-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12638912 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Abilify PS Otsuka Initial or Prolonged Dystonia Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL only took one dose Date:11/29/04ISR Number: 4511405-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12639738 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Abilify PS Otsuka Initial or Prolonged Akathisia Pharmaceutical Other Anxiety Company, Ltd. ORAL Psychomotor Hyperactivity Haldol C Treatment Noncompliance Cogentin C Valproate C Date:11/29/04ISR Number: 4511406-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12640041 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Option of an additional dose of 10 mg/day Prozac C Date:11/29/04ISR Number: 4511407-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12645156 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/day dosing tapered Adderall C dose-tapered Date:11/29/04ISR Number: 4511408-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12652129 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicidal Ideation Abilify PS Otsuka Hospitalization - Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Disability Eskalith Cr C Other Prozac C Serzone C Bristol-Myers Squibb Company Geodon C Risperdal C Zyprexa C 22-Feb-2006 08:31 AM Page: 616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511409-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12652418 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Insulin C Zyprexa C Lithonate C Date:11/29/04ISR Number: 4511410-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12657094 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL Increased to 30 mg/day then in Sep-2003 dose was decreased Klonopin C Prozac C Date:11/29/04ISR Number: 4511411-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12657995 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL 2 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Zoloft C Cogentin C Date:11/29/04ISR Number: 4511412-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12658340 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Abilify PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL Ativan C Date:11/29/04ISR Number: 4511413-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12659488 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511414-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12660437 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511415-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12660445 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511416-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12660528 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511417-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12660569 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Stomach Discomfort Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Date:11/29/04ISR Number: 4511418-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12660783 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Abilify Tabs 15 Mg PS Otsuka Medication Error Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL Paranoia Lexapro C Date:11/29/04ISR Number: 4511419-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12661757 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify PS Otsuka Oedema Peripheral Pharmaceutical Company, Ltd. ORAL Celexa C Klonopin C Seroquel C Adderall C 22-Feb-2006 08:31 AM Page: 618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511420-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12661864 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Discomfort Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:11/29/04ISR Number: 4511421-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12662250 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 10 mg/day from 28-Apr-04 to 06-May-04, increased to Bupropion C Celexa C Zyprexa C Hctz C Ativan C Metoprolol C Trazodone Hcl C Apothecon Date:11/29/04ISR Number: 4511422-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663399 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 5 mg, then 10 mg, then d/c, then 5 mg, then 10 mg - continues Lithium Carbonate C Clonidine C 4 MON Date:11/29/04ISR Number: 4511423-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663407 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL In May-2004 the patient began taking aripiprazole at a low dose Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL In May-2004 the patient began taking aripiprazole at a low dose 22-Feb-2006 08:31 AM Page: 619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trileptal C Trazodone Hcl C Apothecon Lamictal C Lorazepam C Nasacort C Flexeril C Levoxyl C Date:11/29/04ISR Number: 4511424-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663415 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Effect Abilify PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511425-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663464 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511426-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663480 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Abilify PS Otsuka Tension Pharmaceutical Company, Ltd. ORAL Effexor Xr C Synthroid C Triamterene + Hctz C Detrol C Verapamil Er C Coral Calcium C Vitamin B Complex C Vitamin C C Flaxseed Oil C Prempro C Date:11/29/04ISR Number: 4511427-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663555 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 MON Antidepressant C 22-Feb-2006 08:31 AM Page: 620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511428-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Duration of therapy: a few months Speed C Date:11/29/04ISR Number: 4511430-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663860 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Nausea Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511431-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12664652 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Reaction Abilify Tabs 10 Mg PS Otsuka Dystonia Pharmaceutical Company, Ltd. ORAL Trileptal C Date:11/29/04ISR Number: 4511432-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12664843 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Nausea Pharmaceutical Nervousness Company, Ltd. ORAL 30 mg/day Pain from Jul-03 Restlessness to Aug-03. Weight Decreased Restarted @ 15 mg/day in Seroquel C Buspar C Bristol-Myers Squibb Company Artane C Glucovance C Bristol-Myers Squibb Company Prozac C Valium C Nexium C Lithium C Vicodin C Crestor C Ultram C Tylenol #4 C Prevacid C 22-Feb-2006 08:31 AM Page: 621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511433-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12666673 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 10 Mg PS Otsuka Musculoskeletal Stiffness Pharmaceutical Pyrexia Company, Ltd. ORAL 1/2 of a 10 mg tablet; decreased to 2.5 mg/day Lexapro C Allegra C Albuterol C Pulmicort C 2 puffs Date:11/29/04ISR Number: 4511434-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12666699 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511435-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12666988 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511436-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12667846 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 15 Mg PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. ORAL Depakote C Wellbutrin C Date:11/29/04ISR Number: 4511437-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12667887 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Encopresis Abilify PS Otsuka Enuresis Pharmaceutical Muscle Contracture Company, Ltd. ORAL Sleep Disorder Strattera C Tic Date:11/29/04ISR Number: 4511438-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12667903 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:11/29/04ISR Number: 4511439-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12668265 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511440-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12668273 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511441-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12669479 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify PS Otsuka Dizziness Pharmaceutical Company, Ltd. ORAL Zoloft C Date:11/29/04ISR Number: 4511442-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12669693 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511443-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12669834 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Date:11/29/04ISR Number: 4511444-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12669982 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Abilify PS Otsuka Initial or Prolonged Drooling Pharmaceutical Other Increased Appetite Company, Ltd. ORAL Parkinsonism Weight Increased 22-Feb-2006 08:31 AM Page: 623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511445-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12670485 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Excitability Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511446-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12671327 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Head Banging Abilify PS Otsuka Pharmaceutical Company, Ltd. Cogentin C Luvox C Plaquenil C Remeron C Neurontin C Tegretol C Topamax C Date:11/29/04ISR Number: 4511447-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12671343 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Head Banging Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Thorazine C Multivitamin C Date:11/29/04ISR Number: 4511448-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12671368 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Celexa C Zantac C Date:11/29/04ISR Number: 4511449-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12672465 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Abilify PS Otsuka Sedation Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511450-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12673570 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511451-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12674412 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Unknown initiation dose. Interrupted and restarted Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Unknown initiation dose. Interrupted and restarted Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Unknown initiation dose. Interrupted and restarted Celexa C Strattera C Date:11/29/04ISR Number: 4511452-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12674909 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511453-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12675229 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Abilify PS Otsuka Sedation Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511454-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12676078 Age:24 YR Gender:Female I/FU:F Outcome PT Akathisia Insomnia 22-Feb-2006 08:31 AM Page: 625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Macroglossia Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Klonopin C Date:11/29/04ISR Number: 4511455-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12676169 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Abilify PS Otsuka Nausea Pharmaceutical Tremor Company, Ltd. ORAL 3 WK Artane C Valium C Compazine C Levoxyl C Buspar C Bristol-Myers Squibb Company Prozac C Glucovance C Bristol-Myers Squibb Company Crestor C Prevacid C Nexium C Reglan C Tylenol #4 C Ultram C Vicodin C Lithium C Zoloft C Date:11/29/04ISR Number: 4511456-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12676300 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 15 mg/day, then discontinued Date:11/29/04ISR Number: 4511457-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12676904 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511458-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12677506 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphasia Abilify PS Otsuka Musculoskeletal Stiffness Pharmaceutical Company, Ltd. Decreased to 5 mg/day, then discontinued. Date:11/29/04ISR Number: 4511459-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12677548 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify PS Otsuka Pharmaceutical Company, Ltd. Risperdal C Date:11/29/04ISR Number: 4511460-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12677555 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511461-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12677605 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511462-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12677696 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affect Lability Abilify Tabs 10 Mg PS Otsuka Irritability Pharmaceutical Restlessness Company, Ltd. ORAL 1/2 of a 10 Sleep Disorder mg tablet in am Trazodone Hcl C Apothecon at night Bactrim C Date:11/29/04ISR Number: 4511463-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12678322 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511464-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12678389 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Nalbuphine C Date:11/29/04ISR Number: 4511465-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12678538 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Astigmatism Abilify PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511466-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12678959 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL tapering off Date:11/29/04ISR Number: 4511467-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12679916 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511468-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12680005 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511469-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12680567 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Aripiprazole PS Otsuka Initial or Prolonged Confusional State Pharmaceutical Disorientation Company, Ltd. 3 DAY Date:11/29/04ISR Number: 4511470-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12680989 Age:14 YR Gender:Male I/FU:F Outcome PT Disability Asthenia Cold Sweat Dizziness 22-Feb-2006 08:31 AM Page: 628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Pallor Tremor Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreassed to 5 mg/day, then 2.5 mg/day, then discontinued Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreassed to 5 mg/day, then 2.5 mg/day, then discontinued Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreassed to 5 mg/day, then 2.5 mg/day, then discontinued Depakote C Clonidine C Date:11/29/04ISR Number: 4511471-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12681342 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Hypotension Pharmaceutical Company, Ltd. ORAL Decreased to 2.5 mg/day, then discontinued Zyprexa C Date:11/29/04ISR Number: 4511472-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12681383 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511473-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12681656 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511474-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12682811 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify PS Otsuka Pain In Jaw Pharmaceutical Company, Ltd. ORAL Voltaren C Simethicone C chewables Premarin C VAG CREAM Risedronate Sodium C Vitamin E C Lorazepam C every 4 hours as needed Clonazepam C twice daily and at bedtime Date:11/29/04ISR Number: 4511475-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12684338 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511476-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12684411 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Abilify PS Otsuka Dry Eye Pharmaceutical Company, Ltd. ORAL 2 YR Advair C Diovan C Trileptal C 600 mg/am, 900 mg/pm Buspar C Bristol-Myers Squibb Company Date:11/29/04ISR Number: 4511477-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12684676 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Priapism Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozapine C ORAL 10 YR Depakote C 10 YR Date:11/29/04ISR Number: 4511478-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685160 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511479-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685178 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511480-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685186 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511481-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685194 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511482-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685202 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511483-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685277 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify PS Otsuka Epistaxis Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511484-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12685293 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify PS Otsuka Constipation Pharmaceutical Nausea Company, Ltd. ORAL Weight Increased Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511485-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12686069 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Abilify Tabs 10 Mg PS Otsuka Muscle Spasms Pharmaceutical Nervousness Company, Ltd. ORAL Zoloft C Date:11/29/04ISR Number: 4511486-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12686085 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 30 Mg PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/twice daily Date:11/29/04ISR Number: 4511487-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12686762 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Abilify PS Otsuka Dysphagia Pharmaceutical Musculoskeletal Stiffness Company, Ltd. 5 mg/day to Swollen Tongue 10 mg/day for 1 week 1 WK Date:11/29/04ISR Number: 4511488-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12687091 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511489-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12687307 Age:3 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 1 MON Date:11/29/04ISR Number: 4511490-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12687992 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511491-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12688636 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511492-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12689279 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Hyperpigmentation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511493-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12689303 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 20 Mg PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. ORAL increased dose to 20 mg/twice daily. Date:11/29/04ISR Number: 4511494-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12689725 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511495-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12689733 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Haldol C Date:11/29/04ISR Number: 4511496-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12689857 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511497-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12689881 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511498-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12690053 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511499-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12691069 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 DAY Date:11/29/04ISR Number: 4511500-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12691101 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511501-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12691309 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511502-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12691473 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify PS Otsuka Headache Pharmaceutical Company, Ltd. ORAL 2 DAY Lexapro C Depakote C Alprazolam C 22-Feb-2006 08:31 AM Page: 634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511504-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12692331 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify PS Otsuka Urinary Incontinence Pharmaceutical Company, Ltd. ORAL Risperdal C Date:11/29/04ISR Number: 4511505-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12692356 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Restlessness Pharmaceutical Treatment Noncompliance Company, Ltd. Date:11/29/04ISR Number: 4511506-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12692455 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Aripiprazole PS Otsuka Initial or Prolonged Increased Pharmaceutical Aspartate Company, Ltd. Dosing Aminotransferase initiated 5 Increased days prior to Neuroleptic Malignant hospital Syndrome admission on Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. Dosing initiated 5 days prior to hospital admission on Haloperidol C Trazodone Hcl Tabs C Apothecon Benztropine C Lorazepam C Date:11/29/04ISR Number: 4511507-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12693172 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Bilirubin Increased Abilify PS Otsuka Cogwheel Rigidity Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Bisacodyl C Salazopyrin C Docusate C Nortriptyline C Trazodone Hcl C Apothecon Acetaminophen + 22-Feb-2006 08:31 AM Page: 635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Codeine Phosphate C Date:11/29/04ISR Number: 4511508-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12693586 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Effect Abilify PS Otsuka Overdose Pharmaceutical Suicide Attempt Company, Ltd. ORAL Date:11/29/04ISR Number: 4511510-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12693784 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Date:11/29/04ISR Number: 4511511-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12694659 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify PS Otsuka Restlessness Pharmaceutical Vomiting Company, Ltd. ORAL 3 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Haldol C INTRAMUSCULAR Cogentin C Date:11/29/04ISR Number: 4511512-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12695052 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL Started on Aminotransferase 08-Jun-2004 Increased at 10 mg; Blood Cholesterol increased to Increased 15 mg on Weight Decreased Haldol C Trazodone Hcl C Apothecon ORAL 50 mg to 100 mg qhs. Date:11/29/04ISR Number: 4511513-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12695649 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Univasc C 22-Feb-2006 08:31 AM Page: 636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zocor C Date:11/29/04ISR Number: 4511514-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12695706 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Musculoskeletal Stiffness Abilify PS Otsuka Nuchal Rigidity Pharmaceutical Company, Ltd. ORAL Celexa C Mirtazapine C Lorazepam C Date:11/29/04ISR Number: 4511515-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12696373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conjunctivitis Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511516-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12696415 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MIN Seroquel C Date:11/29/04ISR Number: 4511517-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12697967 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthritis Abilify PS Otsuka Dizziness Pharmaceutical Formication Company, Ltd. Hallucination, Auditory Mental Impairment Nervousness Pruritus Restlessness Date:11/29/04ISR Number: 4511518-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698049 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cold Sweat Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511519-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698205 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511520-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698304 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Swollen Tongue Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Concerta C Luvox C Depakote C Clonidine C Date:11/29/04ISR Number: 4511521-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698312 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C Date:11/29/04ISR Number: 4511522-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698353 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Abilify PS Otsuka Rash Pharmaceutical Company, Ltd. ORAL 2 WK Geodon C Lexapro C Metoprolol C Norvasc C Pravachol C Bristol-Myers Squibb Company Remeron C Strattera C Xanax C Date:11/29/04ISR Number: 4511523-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698445 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511524-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698452 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511525-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12698858 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Feeling Jittery Pharmaceutical Company, Ltd. Lithium C Date:11/29/04ISR Number: 4511526-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12699476 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psoriasis Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL started 20-Mar-04 x 1 wk, then d/c, re-started 11-Jun-2004 & Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL started 20-Mar-04 x 1 wk, then d/c, re-started 11-Jun-2004 & Wellbutrin Xl C Neurontin C Premarin C Date:11/29/04ISR Number: 4511527-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12699492 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Abilify PS Otsuka Nasopharyngitis Pharmaceutical Paranasal Sinus Company, Ltd. ORAL Hypersecretion Zyprexa C Schizophrenia Ativan C Weight Decreased Norvasc C Date:11/29/04ISR Number: 4511528-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700282 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Clozapine C 22-Feb-2006 08:31 AM Page: 639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511529-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700340 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511530-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700381 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. Strattera C Seroquel C Neurontin C Date:11/29/04ISR Number: 4511531-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700670 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 12 MON Depakote C 250 mg in a.m. and 500 mg in p.m. Date:11/29/04ISR Number: 4511532-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700704 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL decreased to 15 mg/day on 16-Sep-2004 Depakote C qhs Ddavp C Date:11/29/04ISR Number: 4511533-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12702619 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradykinesia Abilify PS Otsuka Dysarthria Pharmaceutical Company, Ltd. ORAL Catapres C Lexapro C Wellbutrin C 22-Feb-2006 08:31 AM Page: 640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511534-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12702742 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Metrorrhagia Abilify PS Otsuka Nausea Pharmaceutical Sedation Company, Ltd. ORAL Topamax C Wellbutrin C Lamictal C Adderall C Zoloft C Klonopin C Date:11/29/04ISR Number: 4511535-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12703567 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Lexapro C Decreased to 5 mg/day and then to 2.5 mg/day Date:11/29/04ISR Number: 4511536-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12704169 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511537-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12704359 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urticaria Abilify PS Otsuka White Blood Cell Count Pharmaceutical Increased Company, Ltd. ORAL Date:11/29/04ISR Number: 4511538-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12704870 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511539-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12704961 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicidal Ideation Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Topamax C Date:11/29/04ISR Number: 4511540-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12705679 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511541-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12705851 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511542-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12706784 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511543-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12706883 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511544-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12706933 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511545-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12707444 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON 22-Feb-2006 08:31 AM Page: 642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511546-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12708251 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Abilify PS Otsuka Initial or Prolonged Consciousness Pharmaceutical Hypoglycaemia Company, Ltd. ORAL Risperdal C Seroquel C Lithium C Paxil C Date:11/29/04ISR Number: 4511547-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12709150 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511548-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12709614 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Acne Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511549-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12709697 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Abilify PS Otsuka Pharmaceutical Company, Ltd. Wellbutrin C Date:11/29/04ISR Number: 4511550-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12709739 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511551-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12710224 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Synthroid C Xanax C Lasix C Singulair C 22-Feb-2006 08:31 AM Page: 643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511552-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12710760 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511553-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12711719 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Abilify PS Otsuka Initial or Prolonged Chills Pharmaceutical Dizziness Company, Ltd. ORAL Loss Of Consciousness Lexapro C Syncope Date:11/29/04ISR Number: 4511554-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12712113 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511555-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12712238 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Visual Disturbance Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day, increased to 15 mg/day. Date:11/29/04ISR Number: 4511556-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12712253 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 15 mg/day. Risperdal C initially on 10 mg/day. Date:11/29/04ISR Number: 4511557-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12713426 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Xanax C 22-Feb-2006 08:31 AM Page: 644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511558-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12713665 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Emotional Disorder Abilify PS Otsuka Flatulence Pharmaceutical Somnolence Company, Ltd. ORAL 2.5 Weight Increased mg/day:Apr, interrupted: Aug-04, 2.5 every other Date:11/29/04ISR Number: 4511559-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12714606 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Strattera C Date:11/29/04ISR Number: 4511560-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12714879 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify PS Otsuka Blood Cholesterol Pharmaceutical Increased Company, Ltd. Dose Blood Triglycerides increased to Increased 15 mg/day in Sep-2004 due to anxiety. Omeprazole C Vicodin C Hydrochlorothiazide C Potassium Supplement C Remeron C Lexapro C Klonopin C Propranolol C Date:11/29/04ISR Number: 4511561-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12715595 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Food Craving Abilify PS Otsuka Hypertrophy Breast Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day in Apr-2004; inc to 10 mg/day in Aug-2004. Wellbutrin C Klonopin C 22-Feb-2006 08:31 AM Page: 645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511562-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12716643 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify PS Otsuka Headache Pharmaceutical Company, Ltd. ORAL Glucophage C Bristol-Myers Squibb Company Synthroid C Allopurinol C Hctz C Date:11/29/04ISR Number: 4511563-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12716668 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. Buspirone SS Serzone SS Bristol-Myers Squibb Company Imipramine C Lamictal C Lithium C Eskalith C Parnate C Wellbutrin C Remeron C Effexor C Xanax C Prozac C Date:11/29/04ISR Number: 4511564-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12716692 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL Depakote I Zyprexa I Date:11/29/04ISR Number: 4511565-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12716767 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Psychomotor Hyperactivity Pharmaceutical Company, Ltd. ORAL Dose modified throughout course of treatment. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose modified throughout course of 22-Feb-2006 08:31 AM Page: 646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report treatment. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose modified throughout course of treatment. Ddavp C Ritalin C Wellbutrin C Date:11/29/04ISR Number: 4511566-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12718193 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Amnesia Pharmaceutical Anorexia Company, Ltd. Weight Decreased Depakote C Concerta C Seroquel C Date:11/29/04ISR Number: 4511567-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12718664 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511568-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12718680 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Taken on and off since Nov-2003 Singulair C Albuterol C Zoloft C Strattera C Date:11/29/04ISR Number: 4511569-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12719225 Age:8 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511570-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12719233 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511571-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12719423 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Zoloft C Trileptal C Date:11/29/04ISR Number: 4511572-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12719480 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Date:11/29/04ISR Number: 4511573-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12719738 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511574-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12720785 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs 10 Mg PS Otsuka Dehydration Pharmaceutical Difficulty In Walking Company, Ltd. ORAL 2 WK Dizziness Fluoxetine Hcl C Dysstasia Insomnia Movement Disorder Date:11/29/04ISR Number: 4511575-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12722450 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511576-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12722476 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erosive Oesophagitis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511577-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12722492 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511578-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12722732 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Abilify Tabs 15 Mg PS Otsuka Increased Pharmaceutical Blood Cholesterol Company, Ltd. ORAL tapered to Increased 7.5 mg/day, Blood Triglycerides then Increased discontinued Nocturia Depakote C ORAL Lithium C Decreased to 300 mg 1 tablet 2 times/day on 15-Sep-2004, Qvar C Albuterol C Gemfibrozil C Date:11/29/04ISR Number: 4511579-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12723144 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511580-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12724282 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511581-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12724704 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511582-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12724852 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatotoxicity Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511583-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12725040 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothermia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511584-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12725362 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Abilify PS Otsuka Migraine Pharmaceutical Company, Ltd. ORAL 1 DAY Venlafaxine Hcl C Seroquel C Date:11/29/04ISR Number: 4511585-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12725859 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Biaxin C Depakote C 250-500 MG/DAY Date:11/29/04ISR Number: 4511586-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12726386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Swelling Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK 22-Feb-2006 08:31 AM Page: 650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511587-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12726774 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511588-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12726790 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 10 mg tablet Effexor C Date:11/29/04ISR Number: 4511589-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12726840 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 MON Date:11/29/04ISR Number: 4511590-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12728176 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Fluticasone C Loratadine C Date:11/29/04ISR Number: 4511591-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12728762 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Atenolol C Geneva Pharmaceuticals Technology, Corp. Mirtazapine C Tramadol C As needed Aspirin C ORAL Date:11/29/04ISR Number: 4511592-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12728788 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor C ORAL Aspirin C ORAL Date:11/29/04ISR Number: 4511593-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12729018 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 5 Mg PS Otsuka Stomach Discomfort Pharmaceutical Company, Ltd. ORAL 5 mg/day from 30 Sep, increased to 7.5 mg/day 7 days later, Vitamins C Date:11/29/04ISR Number: 4511594-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12729117 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 MON Date:11/29/04ISR Number: 4511595-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12729216 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Fall Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511596-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12729224 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify PS Otsuka Urinary Tract Infection Pharmaceutical Company, Ltd. ORAL 1 MON Zoloft C Wellbutrin C Date:11/29/04ISR Number: 4511597-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12729976 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Oedema Peripheral Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Vitamin E C 22-Feb-2006 08:31 AM Page: 652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin B6 C Inderal C Date:11/29/04ISR Number: 4511598-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12730016 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Provigil C Date:11/29/04ISR Number: 4511599-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12730040 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. Decreased to 10 mg/day, then tapered to 5 mg/day then 2.5 Bextra C Zanaflex C Effexor Xr C Date:11/29/04ISR Number: 4511600-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12730537 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511601-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731519 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Generalised Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 2.5 mg/day, increased to 5 mg/day Date:11/29/04ISR Number: 4511602-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731543 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511603-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C Date:11/29/04ISR Number: 4511604-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731584 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Fall Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511605-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731659 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 5 Mg PS Otsuka Urinary Tract Infection Pharmaceutical Vomiting Company, Ltd. ORAL Lamictal C Risperdal C Seroquel C Toprol Xl C Evista C Glucophage Xr Tabs C Bristol-Myers Squibb Company Date:11/29/04ISR Number: 4511606-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12732491 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day, inc to 15 mg/day after 1 week, Lexapro C Date:11/29/04ISR Number: 4511607-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12732533 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg/day Dec-2003; increased to 20 mg Feb-2004; Wellbutrin C Celexa C 22-Feb-2006 08:31 AM Page: 654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Evista C Vitamin C C Multivitamin C Date:11/29/04ISR Number: 4511608-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12732798 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511609-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12733150 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initiated 5 mg/day Apr-04, inc to 10 mg/day Apr-04, inc Trazodone Hcl C Apothecon Date:11/29/04ISR Number: 4511610-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12733523 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Face Injury Pharmaceutical Incoherent Company, Ltd. ORAL Started "about 6 weeks ago" at 15 mg/day. 6 WK Zyprexa C Being reduced due to high lipid levels 3 YR Wellbutrin C Lithium C Trileptal C Date:11/29/04ISR Number: 4511611-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12733606 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511612-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12733945 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Date:11/29/04ISR Number: 4511613-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12734265 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Abilify PS Otsuka Phosphatase Increased Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511614-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12734562 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511615-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12734588 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511617-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12734687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Panic Attack Abilify PS Otsuka Pharmaceutical Company, Ltd. Increased to 30 mg/day in Jul-2004 4 MON Date:11/29/04ISR Number: 4511618-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12734745 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Abilify PS Otsuka Muscle Rigidity Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL Somnolence Tremor 22-Feb-2006 08:31 AM Page: 656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511619-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12735155 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511620-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12735197 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. Lithium C Lamictal C Neurontin C Wellbutrin C Prozac C Date:11/29/04ISR Number: 4511621-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12735684 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lithium C Seroquel C Depakote C Haloperidol C Date:11/29/04ISR Number: 4511622-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12736567 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Abilify PS Otsuka Dystonia Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL Pain In Jaw Seroquel C Tremor Lexapro C Date:11/29/04ISR Number: 4511623-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12736898 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Fluctuation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511624-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12736989 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:11/29/04ISR Number: 4511625-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12737086 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tinnitus Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Benzatropine C Date:11/29/04ISR Number: 4511626-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12737813 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Hyperhidrosis Pharmaceutical Staring Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:11/29/04ISR Number: 4511627-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12737953 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Abilify PS Otsuka Neck Pain Pharmaceutical Company, Ltd. 1 DAY Date:11/29/04ISR Number: 4511628-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12738357 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swollen Tongue Abilify PS Otsuka Tongue Disorder Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511629-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12738365 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Dysphasia Pharmaceutical Tongue Disorder Company, Ltd. ORAL Initiated at 10 mg/day in Aug-2004; increased to 15 mg; Depakote C Zoloft C 22-Feb-2006 08:31 AM Page: 658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511630-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12738530 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Abilify PS Otsuka Heart Rate Increased Pharmaceutical Company, Ltd. ORAL Wellbutrin C Ativan C Date:11/29/04ISR Number: 4511631-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12738688 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511632-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12739264 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Morbid Thoughts Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day Haldol C Prozac C Artane C Date:11/29/04ISR Number: 4511633-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12739702 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511634-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12739769 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 30-Sep-04, 5 mg/day; inc to 10 mg/day on 10-Oct-04; Trileptal C Synthroid C Cogentin C Moban C Norvasc C Hydralazine C 22-Feb-2006 08:31 AM Page: 659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511635-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12740130 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Effect Abilify Tabs 10 Mg PS Otsuka Overdose Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511636-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741849 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Prenatal Vitamins C Date:11/29/04ISR Number: 4511637-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741898 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 5 Mg PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Clonidine C Luvox C Date:11/29/04ISR Number: 4511638-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741914 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 5 Mg PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Clonidine C Luvox C Date:11/29/04ISR Number: 4511639-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741930 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 5 Mg PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Clonidine C Luvox C Date:11/29/04ISR Number: 4511640-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741963 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myalgia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511641-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12742391 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Amnesia Pharmaceutical Anorexia Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Depakote C Concerta C Seroquel C Date:11/29/04ISR Number: 4511642-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12743803 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Abilify PS Otsuka Gait Disturbance Pharmaceutical Company, Ltd. ORAL Decreased to 5 mg/day Lexapro C Buspar C Bristol-Myers Squibb Company Date:11/29/04ISR Number: 4511643-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12745105 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Macrocytic Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511644-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12745170 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Date:11/29/04ISR Number: 4511645-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12746822 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Effect Abilify Tabs 30 Mg PS Otsuka Overdose Pharmaceutical Company, Ltd. ORAL Date:11/29/04ISR Number: 4511646-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12747341 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical 22-Feb-2006 08:31 AM Page: 661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:11/29/04ISR Number: 4511647-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12747374 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Insomnia Pharmaceutical Muscle Twitching Company, Ltd. ORAL Date:11/29/04ISR Number: 4511648-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12748208 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Lithium C Date:11/29/04ISR Number: 4511649-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12748364 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Abilify PS Otsuka Pharmaceutical Company, Ltd. Dose reduced to 7.5 mg/day Date:11/29/04ISR Number: 4511650-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12748513 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511651-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12748539 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify PS Otsuka Myalgia Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511652-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12748554 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511653-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12748935 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Dehydration Pharmaceutical Neuroleptic Malignant Company, Ltd. ORAL Syndrome Cogentin C Depakote C Adderall C Strattera C Date:11/29/04ISR Number: 4511654-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749362 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 DAY Paxil C Blood Pressure Medication C Date:11/29/04ISR Number: 4511655-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749438 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/29/04ISR Number: 4511656-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749479 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Abilify PS Otsuka Confusional State Pharmaceutical Dizziness Company, Ltd. Medication Error Amiodarone C Vomiting Hydrochlorothiazide C Protonix C Aspirin C Colace C Date:11/29/04ISR Number: 4511677-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768065 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Professional Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Increased to Hallucination 30 mg/day Muscle Rigidity after one Schizophrenia week. Social Avoidant Behaviour Clozapine SS Tardive Dyskinesia Quetiapine SS 22-Feb-2006 08:31 AM Page: 663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511878-5Report Type:Periodic Company Report #AU-JNJFOC-20041102372 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Risperdal Consta PS INTRAMUSCULAR 43 DAY Initial or Prolonged Amisulpride SS Aripiprazole SS Date:11/29/04ISR Number: 4515770-1Report Type:Expedited (15-DaCompany Report #DSA_25396_2004 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Tavor PS SUBLINGUAL 5 MG Q DAY; Delirium Health SL Disorientation Professional Tavor SS SUBLINGUAL 5 MG Q DAY; Drug Level Decreased Other SL Speech Disorder Tavor SS SUBLINGUAL 2.5 MG Q DAY; SL Tavor SS SUBLINGUAL 10 MG Q DAY; SL Tavor SS SUBLINGUAL 5 MG Q DAY; SL Tavor SS SUBLINGUAL 7.5 MG Q DAY; SL Tavor SS SUBLINGUAL 2.5 MG Q DAY; SL Abilify SS UNKNOWN 30 MG Q DAY; Akineton SS UNKNOWN 4 MG Q DAY; Akineton SS UNKNOWN DF Abilify SS UNKNOWN 15 MG Q DAY, Akineton SS UNKNOWN 4 MG Q DAY; Nozinan SS UNKNOWN 150 MG Q DAY; Risperdal SS UNKNOWN 5 MG Q DAY; Risperdal SS UNKNOWN 3 MG Q DAY; Date:11/30/04ISR Number: 4512946-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772208 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Abilify PS Otsuka Sexual Dysfunction Pharmaceutical Weight Decreased Company, Ltd. ORAL Started 10 mg/day, inc to 15 mg/day 12-Oct-04, inc to 20 Date:11/30/04ISR Number: 4518149-1Report Type:Expedited (15-DaCompany Report #S04-USA-07259-01 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Consumer Lexapro (Escitalopram) PS ORAL 15 MG QD PO Klonopin (Clonazepam) SS ORAL 8 MG QD PO Abilify SS ORAL 5 MG QD PO Trileptal SS ORAL 900 MG QD PO Zocor C 22-Feb-2006 08:31 AM Page: 664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/04ISR Number: 4514849-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768032 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Abilify PS Otsuka Hospitalization - Fluctuation Pharmaceutical Initial or Prolonged Confusional State Company, Ltd. ORAL Disability Heart Rate Irregular Effexor Xr C Other Hyperhidrosis Cipramil C Hyperpyrexia Atorvastatin C Hypertonia Premique C Neuroleptic Malignant Movicol C Syndrome Clonazepam C Diazepam C Calogen C Fresubin C Date:12/01/04ISR Number: 4515056-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12770947 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Abilify PS Otsuka Other Death Pharmaceutical Delusion Company, Ltd. Drug Level Increased Clozapine SS ORAL Paranoia Lexapro C ORAL Treatment Noncompliance Klonopin C White Blood Cell Count Increased Date:12/01/04ISR Number: 4519036-5Report Type:Expedited (15-DaCompany Report #2004GB02737 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Quetiapine PS ORAL 250 MG PO Initial or Prolonged Phosphokinase Increased Health Clozapine SS Condition Aggravated Professional Abilify SS ORAL 15 MG HS PO Disturbance In Attention Other Abilify SS ORAL 30 MG HS PO Hallucination Mental Impairment Muscle Rigidity Social Avoidant Behaviour Tardive Dyskinesia Date:12/02/04ISR Number: 4516748-4Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12726238 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Impulsive Behaviour Abilify PS Otsuka Initial or Prolonged Lacrimation Increased Pharmaceutical Photophobia Company, Ltd. ORAL Visual Acuity Reduced 22-Feb-2006 08:31 AM Page: 665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/04ISR Number: 4518882-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12774808 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Abilify PS Otsuka Initial or Prolonged Abnormal Pharmaceutical Schizophrenia Company, Ltd. ORAL Date:12/06/04ISR Number: 4519097-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741450 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Aripiprazole PS Otsuka Hospitalization - Coma Pharmaceutical Initial or Prolonged Completed Suicide Company, Ltd. ORAL Drug Abuser Paroxetine SS ORAL Hyperchloraemia Olanzapine SS ORAL Hyperglycaemia Carbamazepine SS Hypernatraemia Hypokalaemia Rhabdomyolysis Supraventricular Tachycardia Date:12/06/04ISR Number: 4519131-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12773560 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Catatonia Abilify PS Otsuka Other Pharmaceutical Company, Ltd. ORAL Procyclidine C ORAL Omeprazole C ORAL Allopurinol C ORAL Spironolactone C ORAL Temazepam C ORAL Thiamine C ORAL Lorazepam C ORAL Vitamin B C ORAL Date:12/06/04ISR Number: 4519281-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741617 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Abilify PS Otsuka Coma Pharmaceutical Drug Toxicity Company, Ltd. ORAL Multiple Drug Overdose Methamphetamine Hcl SS ORAL Intentional Sertraline SS ORAL Therapy Non-Responder Loratadine SS Alprazolam SS Date:12/07/04ISR Number: 4520088-7Report Type:Expedited (15-DaCompany Report #DK-BRISTOL-MYERS SQUIBB COMPANY-12777025 Age:38 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased 22-Feb-2006 08:31 AM Page: 666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Excitability Fracture Grand Mal Convulsion Report Source Product Role Manufacturer Route Dose Duration Labile Blood Pressure Abilify PS Otsuka Liver Function Test Pharmaceutical Abnormal Company, Ltd. ORAL 22 DAY Muscle Rigidity Leponex C 324 DAY Restlessness Triatec C Codeine C Spirocort C inhalation Date:12/07/04ISR Number: 4520377-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785408 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Premature Baby Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:12/07/04ISR Number: 4520378-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12784559 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Premature Baby Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:12/07/04ISR Number: 4521971-9Report Type:Direct Company Report #CTU 233815 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Aripiprazole PS ORAL 15MG AM ORAL Date:12/08/04ISR Number: 4521307-3Report Type:Expedited (15-DaCompany Report #PHEH2004US12835 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Limb Discomfort Trileptal PS Novartis Sector: Thrombophlebitis Pharma 900 mg, QD Escitalopram SS ORAL 15 mg, QD Clonazepam SS 8 mg, QD Aripiprazole SS 5 mg, QD Simvastatin C 20 mg, QD Date:12/08/04ISR Number: 4532555-0Report Type:Periodic Company Report #20040600323 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Study Lorazepam (Baxter) PS Baxter INTRAMUSCULAR 2 MG ONCE IM Other Aripiprazole (Bristol Myers Squibb) SS Bristol Myers Squibb INTRAMUSCULAR 15 MG IM Placebo SS INTRAMUSCULAR 15 MG IM 22-Feb-2006 08:31 AM Page: 667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/04ISR Number: 4521869-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12779609 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Date:12/09/04ISR Number: 4521904-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781373 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatomegaly Abilify PS Otsuka Splenomegaly Pharmaceutical Company, Ltd. ORAL Date:12/09/04ISR Number: 4521937-9Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12693727 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Aripiprazole PS Otsuka Initial or Prolonged Delusion Pharmaceutical Drug Ineffective Company, Ltd. ORAL 15mg Hallucination, Auditory 07-Mar-04 to Schizophrenia 11-Jul-04, 30mg 12-Jul-04 to 142 DAY Depakin C Rivotril C Date:12/09/04ISR Number: 4521939-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12763652 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Abilify PS Otsuka Diarrhoea Pharmaceutical Drug Interaction Company, Ltd. ORAL 1 MON Drug Toxicity Atazanavir C Bristol-Myers Squibb Malaise Company 6 MON Nausea Norvir I Therapeutic Agent Toxicity Vomiting Date:12/10/04ISR Number: 4523038-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12777728 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Abilify PS Otsuka Therapeutic Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril SS Started at 400 mg/day, decreased to 300 mg/day 22-Feb-2006 08:31 AM Page: 668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report when Date:12/13/04ISR Number: 4524835-XReport Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12780466 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Feeling Abnormal Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Imovane C Date:12/13/04ISR Number: 4524870-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12767034 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Abilify PS Otsuka Hospitalization - Dyspnoea Pharmaceutical Initial or Prolonged Fluid Retention Company, Ltd. ORAL 36 DAY Oedema Peripheral Crestor C ORAL Pain Glucophage C Bristol-Myers Squibb Weight Increased Company ORAL Norvasc C ORAL Lisinopril C ORAL Date:12/14/04ISR Number: 4527197-7Report Type:Direct Company Report #CTU 234222E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Abilify PS ORAL 15 MG P.O. Initial or Prolonged Back Pain DAILY IN AM Nausea Eskalith Cr C Pancreatitis Xanax C Weight Decreased Zoloft C Neurontin C Date:12/14/04ISR Number: 4527199-0Report Type:Direct Company Report #CTU 234223 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Discomfort Abilify PS ORAL 15 MG P.O. Alcohol Use DAILY WITH Decreased Appetite EVENING MEAL Impaired Work Ability Neurontin C Nausea Effexor C Pancreatitis Refusal Of Treatment By Patient Date:12/20/04ISR Number: 4531543-8Report Type:Expedited (15-DaCompany Report #BR-BRISTOL-MYERS SQUIBB COMPANY-12789467 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Abilify PS Otsuka Myocardial Infarction Pharmaceutical Company, Ltd. ORAL 1 DAY Haloperidol C Chlorpromazine C 22-Feb-2006 08:31 AM Page: 669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levomepromazine C Biperidene C Date:12/20/04ISR Number: 4531557-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12716981 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Abilify PS Otsuka Initial or Prolonged Urosepsis Pharmaceutical Other Company, Ltd. ORAL 6 DAY Date:12/20/04ISR Number: 4531846-7Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12726238 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Impulsive Behaviour Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Dose reduced to 10 mg/day on 01-Oct-2004, discontinued 41 DAY Date:12/20/04ISR Number: 4531848-0Report Type:Expedited (15-DaCompany Report #DK-BRISTOL-MYERS SQUIBB COMPANY-12777025 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Excitability Company, Ltd. ORAL 22 DAY Fracture Leponex C 324 DAY Grand Mal Convulsion Triatec C Humerus Fracture Codeine C Liver Function Test Spirocort C inhalation Abnormal Neuroleptic Malignant Syndrome Restlessness Date:12/20/04ISR Number: 4532074-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12784559 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Caesarean Section Health Abilify PS Otsuka Drug Exposure During Professional Pharmaceutical Pregnancy Company, Ltd. Premature Baby Premature Rupture Of Membranes Small For Dates Baby Twin Pregnancy 22-Feb-2006 08:31 AM Page: 670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/04ISR Number: 4532075-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785408 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Premature Baby Health Abilify PS Otsuka Professional Pharmaceutical Company, Ltd. Date:12/20/04ISR Number: 4536998-0Report Type:Expedited (15-DaCompany Report #2004-123324-NL Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bone Marrow Depression Foreign Mirtazapine PS ORAL 45 MG ORAL 1 YR Hospitalization - Haemoglobin Decreased Aripiprazole SS ORAL 15 MG ORAL 2 MON Initial or Prolonged Neutrophil Count Bendrofluazide C Decreased Diazepam C Platelet Count Decreased Esomeprazole C White Blood Cell Count Loperamide C Decreased Date:12/21/04ISR Number: 4533385-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12789533 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bone Marrow Depression Abilify PS Otsuka Hospitalization - Haemoglobin Decreased Pharmaceutical Initial or Prolonged Platelet Count Decreased Company, Ltd. ORAL White Blood Cell Count Mirtazapine SS ORAL Decreased Bendroflumethiazide C Apothecon ORAL Diazepam C ORAL Esomeprazole C ORAL Loperamide C ORAL Date:12/21/04ISR Number: 4533626-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12791117 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Abilify PS Otsuka Below Therapeutic Pharmaceutical Weight Increased Company, Ltd. ORAL Lithium C Date:12/22/04ISR Number: 4534564-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12766093 Age:93 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Abilify PS Otsuka Pneumonia Pharmaceutical Company, Ltd. Date:12/22/04ISR Number: 4535649-9Report Type:Direct Company Report #CTU 234908 E Age:38 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Other Required PT Report Source Product Role Manufacturer Route Dose Duration Intervention to Coma Abilify PS PLUS Prevent Permanent Prescribed Overdose INJECTIONS 2 Impairment/Damage Suicide Attempt X A DAY Tooth Disorder 2001-2004 Zyprexa 40 Mg SS 3 X DAY 10/04-PRES Risperdal 13 Mg SS Prolaxian 20 Mg SS Depakote 2500 SS Seraquel 800 Mg SS Cogentin 4 Mg SS Others SS Date:12/23/04ISR Number: 4536070-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12564977 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL 15mg 23-Mar-04 to 30-Mar-04, increased to 30mg Venlafaxine Hcl C Panadol C Zopiclone C Date:12/23/04ISR Number: 4536083-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12799581 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Abilify PS Otsuka Initial or Prolonged Circulatory Collapse Pharmaceutical Other Confusional State Company, Ltd. ORAL 15 DAY Disorientation Olanzapine C Headache Depakote C Hypothermia Aspirin C Malaise Memory Impairment Musculoskeletal Stiffness Pain Syncope Tremor Date:12/23/04ISR Number: 4536085-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12733887 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Schizophrenia Pharmaceutical Company, Ltd. ORAL Dose changed on 20-Oct-2004 and the 22-Feb-2006 08:31 AM Page: 672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report patient Date:12/23/04ISR Number: 4536790-7Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12768024 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Abilify PS Otsuka Drug Exposure During Pharmaceutical Pregnancy Company, Ltd. ORAL Dosing to be Heart Disease Congenital confirmed. 65 DAY Kidney Malformation Effexor Xr C Limb Malformation Olanzapine C ORAL 2-5 MG 69 DAY Pregnancy Haloperidol C Dicloxacillin C 55 DAY Alprazolam (Gen) C 15 DAY Venlafaxine Hcl C Date:12/23/04ISR Number: 4538484-0Report Type:Direct Company Report #CTU 235067 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Clozapine 800 Mg/Day PS SEE IMAGE Blood Creatinine Abilify 15 Mg/Day SS 15 MG /DAY Increased Haldol Prn SS Blood Gases Abnormal Geodon X 1 SS SEE IMAGE Cholinergic Syndrome Dialysis Diarrhoea Electrolyte Imbalance Hallucination Incoherent Lethargy Neuroleptic Malignant Syndrome Urinary Retention Date:12/27/04ISR Number: 4538176-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12799854 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 15 mg/day Oct-2004; then d/c; then reintroduced Solian C Haloperidol C Lorazepam C Date:12/27/04ISR Number: 4538178-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12795969 Age:41 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Other PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify PS Otsuka Hallucination Pharmaceutical Hostility Company, Ltd. ORAL 33 DAY Mania Chlorpromazine C 15 DAY Suspiciousness Diazepam C Lormetazepam C Quetiapine C 193 DAY Date:12/27/04ISR Number: 4538281-6Report Type:Expedited (15-DaCompany Report #DK-BRISTOL-MYERS SQUIBB COMPANY-12795076 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK Date:12/27/04ISR Number: 4538282-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12796264 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Contusion Abilify PS Otsuka Laceration Pharmaceutical Road Traffic Accident Company, Ltd. ORAL Date:12/27/04ISR Number: 4538299-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12691226 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Abilify PS Otsuka Conduction Disorder Pharmaceutical Electrocardiogram Qt Company, Ltd. ORAL Corrected Interval Theophylline Calcium Prolonged Salicylate C ORAL Sinus Tachycardia Amaryl C ORAL Unat C ORAL Allopurinol C ORAL Zeldox C ORAL Isosorbide Mononitrate C ORAL Ipratropium + Fenoterol C RESPIRATORY (INHALATION) Enoxaparin C SUBCUTANEOUS Tavor C ORAL Torem C ORAL Date:12/27/04ISR Number: 4539558-0Report Type:Direct Company Report #CTU 235187 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify 10mg PS ORAL 10 MG PO HS Joint Stiffness Movement Disorder 22-Feb-2006 08:31 AM Page: 674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/04ISR Number: 4539391-XReport Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12798450 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Company, Ltd. Cipramil C 20 mg 05-Aug-04 to 20-Sep-04; then 40 mg 20-Sep-04 Date:12/28/04ISR Number: 4539653-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12799011 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Febrile Abilify PS Otsuka Initial or Prolonged Neutrophilic Dermatosis Pharmaceutical Company, Ltd. ORAL 42 DAY Promethazine C ORAL Lactulose C ORAL 2 x 1 tablespoon Date:12/28/04ISR Number: 4539655-XReport Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12720389 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL 15mg 29-Sep-2004 to 04-Oct-2004, increased to 26 DAY Citalopram C Date:12/28/04ISR Number: 4539758-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12799664 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 28 DAY Citalopram C Loperamide C ORAL Gliclazide C ORAL Olanzapine C ORAL Date:12/28/04ISR Number: 4541034-6Report Type:Expedited (15-DaCompany Report #2004-123632-NL Age:42 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Oedema Genital Health Remeron PS ORAL 45 MG QD ORAL Painful Erection Professional Remeron /Net/ SS ORAL 45 MG QD ORAL Post Procedural Oedema Abilify /Usa/ SS ORAL ORAL Priapism Abilify /Usa/ SS ORAL ORAL Date:12/29/04ISR Number: 4540472-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12745121 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysfunctional Uterine Abilify PS Otsuka Bleeding Pharmaceutical Ovarian Cyst Company, Ltd. ORAL Stopped on 23-Feb-2004; restarted on 13-Jun-2003 and continued Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Stopped on 23-Feb-2004; restarted on 13-Jun-2003 and continued Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Stopped on 23-Feb-2004; restarted on 13-Jun-2003 and continued Wellbutrin C Risperdal C Depo-Provera C Geodon C Date:12/29/04ISR Number: 4540474-9Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12801965 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:12/29/04ISR Number: 4540662-1Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12800934 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Dependence Abilify PS Otsuka Other Overdose Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/04ISR Number: 4540663-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12799623 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Other Pharmaceutical Company, Ltd. ORAL Diazepam C ORAL 41 DAY Pyridoxine C ORAL 52 DAY Microgynon C ORAL 44 DAY Date:12/29/04ISR Number: 4540669-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12799631 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Disturbance In Attention Company, Ltd. 15 then 30 mg Hallucination nocte after Muscle Rigidity one week Schizophrenia Clozapine SS UNKNOWN Social Avoidant Behaviour Quetiapine SS UNKNOWN Tardive Dyskinesia Date:12/29/04ISR Number: 4543232-4Report Type:Expedited (15-DaCompany Report #2004GB02737 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Quetiapine PS ORAL 350 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Condition Aggravated Professional Clozapine SS Disturbance In Attention Other Abilify SS 15-30MG NOCTE Hallucination Abilify SS ORAL 30 MG HS PO Muscle Rigidity Social Avoidant Behaviour Tardive Dyskinesia Date:12/29/04ISR Number: 4543881-3Report Type:Direct Company Report #CTU 235259 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Abilify 5mg PS BID Intervention to Prevent Permanent Impairment/Damage Date:12/30/04ISR Number: 4543310-XReport Type:Direct Company Report #CTU 235416 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Aripirazole 15 Mg PS ORAL 15 MG Q Increased AM ORAL Weight Increased 22-Feb-2006 08:31 AM Page: 677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/05ISR Number: 4543363-9Report Type:Expedited (15-DaCompany Report #BR-BRISTOL-MYERS SQUIBB COMPANY-12789467 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Abilify PS Otsuka Infarction Pharmaceutical Dyspnoea Company, Ltd. ORAL 1 DAY Myocardial Infarction Levomepromazine SS Haloperidol C Chlorpromazine C 2 MON Biperidene C 2 MON Date:01/04/05ISR Number: 4543836-9Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12726212 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL 15mg 17-Aug-04 to 30-Aug-04, 30mg 31-Aug-04 to Promethazine Hcl C Biperiden Hcl C Nitrazepam C 23 DAY Date:01/04/05ISR Number: 4544015-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12805909 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Abilify PS Otsuka Hospitalization - Weight Increased Pharmaceutical Initial or Prolonged Company, Ltd. ORAL 5 WK Other Date:01/05/05ISR Number: 4548195-3Report Type:Direct Company Report #CTU 235779 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Appetite Abilify PS ORAL 15 MG P.O. Oral Intake Reduced DAILY WITH Pancreatitis EVENING MEAL Treatment Noncompliance Neurontin C Effexor C Mavik C Date:01/05/05ISR Number: 4548197-7Report Type:Direct Company Report #CTU 235778E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Abilify PS ORAL 15 MG P.O. Initial or Prolonged Pancreatitis DAILY IN AM Weight Decreased Eskalith C Xanax C Zoloft C Neurontin C 22-Feb-2006 08:31 AM Page: 678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/05ISR Number: 4546239-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040305774 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Risperdal PS OROPHARINGEAL Initial or Prolonged Overdose Aripiprazole SS OROPHARINGEAL Paranoia Acetaminophen SS Psychotic Disorder Pseudoephedrine C Suicide Attempt Suspiciousness Urinary Incontinence Vomiting Date:01/07/05ISR Number: 4547586-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12808713 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify PS Otsuka Feeling Abnormal Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Suicidal Ideation Prilosec C Thinking Abnormal Benadryl C Weight Decreased Vitamin E C Calcium C Multivitamins C Date:01/10/05ISR Number: 4551224-4Report Type:Expedited (15-DaCompany Report #04-12-1767 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Health Clozapine Tablets - Initial or Prolonged Delusion Professional Ivax Dizziness Other Pharmaceuticals, Fall Inc. PS Ivax Limb Injury Pharmaceuticals, Lower Limb Fracture Inc. ORAL 500-600MG QD ORAL Abilify SS 200MG QAM Neurontin C Eskalith C Date:01/12/05ISR Number: 4550005-5Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12758843 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Abilify Tabs PS Otsuka Initial or Prolonged Phosphokinase Increased Professional Pharmaceutical Myositis Company, Ltd. ORAL 2 WK Date:01/13/05ISR Number: 4554063-3Report Type:Direct Company Report #CTU 236612 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Abilify PS ORAL 5 MG PO DAILY Urinary Retention Trazadone SS ORAL 100 MG PO HS 22-Feb-2006 08:31 AM Page: 679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/05ISR Number: 4552705-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12767034 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Abilify PS Otsuka Hospitalization - Dyspnoea Pharmaceutical Initial or Prolonged Fluid Retention Company, Ltd. ORAL 36 DAY Oedema Peripheral Crestor C ORAL Pain In Extremity Glucophage C Bristol-Myers Squibb Pitting Oedema Company ORAL Weight Increased Norvasc C ORAL Lisinopril C ORAL Date:01/14/05ISR Number: 4552833-9Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12813127 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Abilify PS Otsuka Hospitalization - Increased Pharmaceutical Initial or Prolonged Blood Alkaline Company, Ltd. ORAL 20 DAY Phosphatase Increased Risperdal C ORAL Gamma-Glutamyltransferase Remergil C ORAL Increased Tavor C ORAL Date:01/14/05ISR Number: 4553021-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12759262 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Confusional State Pharmaceutical Depressed Mood Company, Ltd. ORAL Increased to Disorientation 15 mg/day on Disturbance In Attention 02-Oct-2004. Drug Interaction Discontinued Middle Insomnia on 60 DAY Restlessness Eunerpan SS ORAL Social Avoidant Behaviour Enahexal C ORAL Thinking Abnormal Hctz C ORAL Risperdal I ORAL 3 mg/day from 13-Aug-04 to 01-Oct-04; 5 mg/day since 02-Oct-04. Date:01/14/05ISR Number: 4553104-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12811899 Age:44 YR Gender:Male I/FU:I Outcome PT Other Dystonia Dysuria Hyperaesthesia Hypoacusis Hypoaesthesia Insomnia Micturition Urgency Paraesthesia Premature Ejaculation Pruritus Restlessness 22-Feb-2006 08:31 AM Page: 680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 11 DAY Remeron C Zoloft C Ativan C Klonopin C Date:01/14/05ISR Number: 4553125-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050100914 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS OROPHARINGEAL Initial or Prolonged Disturbance In Attention Risperdal SS OROPHARINGEAL Drug Interaction Enahexal C OROPHARINGEAL Mental Disorder Hct Hexal C OROPHARINGEAL Restlessness Abilify I OROPHARINGEAL Sleep Disorder Abilify I OROPHARINGEAL Eunerpan I OROPHARINGEAL Date:01/18/05ISR Number: 4554200-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12813481 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Abilify PS Otsuka Initial or Prolonged Asthenia Pharmaceutical Other Blood Glucose Increased Company, Ltd. ORAL Coma Haldol C Lethargy Cogentin C Pyrexia Thirst Urine Output Increased Date:01/18/05ISR Number: 4554201-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12817235 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Papilloedema Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:01/18/05ISR Number: 4554203-6Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12766234 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Abilify PS Otsuka Pharmaceutical Company, Ltd. Fluoxetine C Zyprexa C ORAL 22-Feb-2006 08:31 AM Page: 681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/05ISR Number: 4555539-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768065 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Increased to Hallucination 30 mg/day Muscle Rigidity after one Schizophrenia week. Social Avoidant Behaviour Clozapine SS Tardive Dyskinesia Quetiapine SS Date:01/19/05ISR Number: 4555540-1Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12800934 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Dependence Abilify PS Otsuka Other Overdose Pharmaceutical Company, Ltd. ORAL Truxal C Date:01/21/05ISR Number: 4558104-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12762142 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initated at 10 mg and titrated up. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initated at 10 mg and titrated up. Serzone SS Bristol-Myers Squibb Company ORAL Serzone SS Bristol-Myers Squibb Company ORAL Klonopin C Date:01/21/05ISR Number: 4558260-2Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12758843 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify Tabs PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Myositis Company, Ltd. ORAL 2 WK Date:01/21/05ISR Number: 4558269-9Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12823209 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Abilify PS Otsuka Completed Suicide Pharmaceutical Drug Toxicity Company, Ltd. ORAL WK 22-Feb-2006 08:31 AM Page: 682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4558558-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12821294 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Citalopram C Date:01/25/05ISR Number: 4560190-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12823902 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Abilify PS Otsuka Infarction Pharmaceutical Coronary Artery Company, Ltd. ORAL 8 DAY Atherosclerosis Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 8 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 8 DAY Aspirin C Ibuprofen C Citalopram C Diazepam C Zopiclone C Donepezil C Quetiapine C Co-Dydramol C Date:01/27/05ISR Number: 4570307-6Report Type:Direct Company Report #CTU 238321E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Abilify 15mg PS ORAL 15MG DAILY Initial or Prolonged Diabetic Ketoacidosis ORAL Nausea Vomiting Date:01/28/05ISR Number: 4563766-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12797650 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL 8 DAY Akineton C INTRAVENOUS Fluanxol C INTRAVENOUS Date:01/28/05ISR Number: 4563798-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12742250 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Hostility Pharmaceutical Schizophrenia Company, Ltd. ORAL 41 DAY 22-Feb-2006 08:31 AM Page: 683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/05ISR Number: 4567223-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12830006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Wellbutrin C Date:02/02/05ISR Number: 4568071-XReport Type:Expedited (15-DaCompany Report #NO-BRISTOL-MYERS SQUIBB COMPANY-12833927 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:02/03/05ISR Number: 4569239-9Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12768024 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Abilify PS Otsuka Kidney Malformation Pharmaceutical Limb Malformation Company, Ltd. ORAL Dosing to be Pregnancy confirmed. 65 DAY Trisomy 21 Effexor Xr C Univentricular Heart Olanzapine C ORAL 2-5 MG 69 DAY Haloperidol C Dicloxacillin C 55 DAY Alprazolam (Gen) C 15 DAY Venlafaxine Hcl C Date:02/04/05ISR Number: 4598328-8Report Type:Periodic Company Report #PHEH2004US07744 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril Sedation Professional (Clozapine)Tablet PS ORAL ORAL Abilify (Aripiprazole) SS Haldol "Janssen" (Haloperidol) C Date:02/07/05ISR Number: 4571556-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12840344 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Abilify PS Otsuka Initial or Prolonged Congestive Pharmaceutical Company, Ltd. Date:02/07/05ISR Number: 4571557-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12749024 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Drug Interaction Initial or Prolonged Hyperhidrosis 22-Feb-2006 08:31 AM Page: 684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose stopped on 22-Oct-04; dec to 7.5 mg/day on 24-Oct-04; Effexor C Rivotril C Nozinan I ORAL Date:02/07/05ISR Number: 4571558-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12838165 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Abilify PS Otsuka Initial or Prolonged Syncope Pharmaceutical Disability Upper Limb Fracture Company, Ltd. ORAL 10-15 mg daily 43 DAY Exelon C ORAL Atorvastatin C Arimidex C Slozem C Gtn Patch C TRANSDERMAL Thyroxine C Atenolol C Sandoz Inc. (Geneva Pharm Tech) Ikorel C Aspirin C Calcichew C Date:02/07/05ISR Number: 4571644-1Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12720389 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 15mg 29-Sep-2004 to 04-Oct-2004, increased to 26 DAY Citalopram C Quetiapine C Date:02/07/05ISR Number: 4578533-7Report Type:Direct Company Report #CTU 239379 E Age:10 YR Gender:Male I/FU:I Outcome PT Hospitalization - Coordination Abnormal Initial or Prolonged Drooling Dystonia Gait Disturbance Muscle Spasms Posture Abnormal 22-Feb-2006 08:31 AM Page: 685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Abilify Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 5 MG DAILY PO Seroquel Astra-Zeneca SS Astra-Zeneca ORAL 225 MG / DAY PO Adderall Xr C Date:02/08/05ISR Number: 4574185-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12840773 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Company, Ltd. ORAL 10 mg 02-Dec-2004, decreased to 5 mg as of 26-Jan-05 Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg 02-Dec-2004, decreased to 5 mg as of 26-Jan-05 Trazodone Hcl C Apothecon Glucotrol C Miacalcin C Clonazepam C Date:02/08/05ISR Number: 4574193-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12841565 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg/day from Sep-2004 to 24-Nov-2004; inc to 15 Risperidone C ORAL 2002, route/dose unknown, IM unknown, 2 mg 2003 to Date:02/08/05ISR Number: 4575117-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12840278 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Topamax C 22-Feb-2006 08:31 AM Page: 686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro C Depakote C Date:02/09/05ISR Number: 4578653-7Report Type:Direct Company Report #CTU 239947 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cogwheel Rigidity Aripiprazole 30 Intervention to Drooling Mg Bristol-Myers Prevent Permanent Dysphagia Squibb PS Bristol-Myers Squibb ORAL 30 MG DAILY Impairment/Damage Dystonia ORAL Gait Disturbance Lorazepam C Musculoskeletal Stiffness Benztropine C Date:02/10/05ISR Number: 4577189-7Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12842688 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify PS Otsuka Initial or Prolonged Anxiety Pharmaceutical Confusional State Company, Ltd. 39 DAY Hallucination Insomnia Negative Thoughts Date:02/11/05ISR Number: 4578382-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12844189 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Abilify PS Otsuka Other Increased Pharmaceutical Aspartate Company, Ltd. 15 mg Aminotransferase 28-Jul-04; 30 Increased mg 09-Nov-04 Blood Cholesterol Abilify SS Otsuka Increased Pharmaceutical Blood Triglycerides Company, Ltd. 15 mg from Increased 28-Jul-2004 Cardiac Failure to Gamma-Glutamyltransferase 08-Nov-2004, Increased 30 mg since Simvastatin C 10 mg since Jul-04 ; then up-titrated to 20 mg mid Nov-04. Date:02/11/05ISR Number: 4578383-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566717 Age:10 YR Gender:Female I/FU:F Outcome PT Other Blood Triglycerides Increased Dizziness Drug Dependence Drug Ineffective Drug Interaction 22-Feb-2006 08:31 AM Page: 687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eye Rolling Fatigue Feeling Abnormal Report Source Product Role Manufacturer Route Dose Duration Lethargy Abilify PS Otsuka Mood Swings Pharmaceutical Nausea Company, Ltd. ORAL Initiated at Somnolence 2.5 mg/day; Weight Increased 5mg Jun-03, 3.5mg 25-May-04, Omega 3 Fish Oil C Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 2.5 mg/day; 5mg Jun-03, 3.5mg 25-May-04, Augmentin I Date:02/11/05ISR Number: 4578391-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12817235 Age:10 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Papilloedema Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/11/05ISR Number: 4578395-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12726014 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Aripiprazole PS Otsuka Initial or Prolonged Delusion Pharmaceutical Schizophrenia Company, Ltd. ORAL Date:02/14/05ISR Number: 4579880-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12845723 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Abilify PS Otsuka Malaise Pharmaceutical Nausea Company, Ltd. ORAL Buspirone C Wellbutrin Sr C Ambien C 5-10 mg at bedtime as needed Date:02/14/05ISR Number: 4579886-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12848289 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/05ISR Number: 4579956-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12821294 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Abilify PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day, increased on 10-Nov-04 to 15 mg/day Omeprazole C ORAL Metformin Hcl C Bristol-Myers Squibb Company ORAL Gliclazide C ORAL Atorvastatin C ORAL Meloxicam C ORAL Clonazepam C ORAL Citalopram C ORAL Flucloxacillin C ORAL Gabapentin C ORAL Penicillin C ORAL Dihydrocodeine C ORAL Senna C ORAL Date:02/14/05ISR Number: 4580343-1Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0490840A Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ageusia Lamictal PS Glaxosmithkline ORAL 300MG Per day 208 DAY Anxiety Aripiprazole SS ORAL 20MG Unknown 61 DAY Risperidone C ORAL 1MG Unknown Date:02/14/05ISR Number: 4585329-9Report Type:Expedited (15-DaCompany Report #2005023545 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Consumer Nardil (Phenelzine Initial or Prolonged Anxiety Sulfate) PS ORAL 45 MG (15 MG, Other Condition Aggravated 1 IN 1 D), Depression ORAL Drug Interaction Quetiapine Fumarate Dry Mouth (Quetiapine Muscle Rigidity Fumarate) SS ORAL 50 MG (50 MG, Nervous System Disorder 1 IN 1 D), Suicidal Ideation ORAL Therapeutic Response Aripiprazole Unexpected (Aripiprazole) SS ORAL 10 MG (10 MG, Tremor 1 IN 1 D), Vision Blurred ORAL Lithium (Lithium) C Date:02/15/05ISR Number: 4589183-0Report Type:Direct Company Report #CTU 240361 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glossitis Abilify 15 Mg PS Bristol-Myers Squibb ORAL 15 MG EVERY Pruritus OTHER DAY Restless Legs Syndrome ORAL 22-Feb-2006 08:31 AM Page: 689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benedryl C Date:02/17/05ISR Number: 4585382-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12813127 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Abilify PS Otsuka Hospitalization - Increased Pharmaceutical Initial or Prolonged Aspartate Company, Ltd. ORAL 20 DAY Aminotransferase Risperdal C ORAL Increased Remergil C ORAL Blood Alkaline Tavor C ORAL Phosphatase Increased Blood Amylase Increased Gamma-Glutamyltransferase Increased Lipase Increased Refusal Of Treatment By Patient Date:02/17/05ISR Number: 4585393-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12799326 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Abilify PS Otsuka Initial or Prolonged Increased Pharmaceutical Other Aspartate Company, Ltd. ORAL 86 DAY Aminotransferase Amoxicillin SS Apothecon ORAL 3 DAY Increased Flupenthixol Confusional State Decanoate C INTRAMUSCULAR Emotional Distress Lorazepam C ORAL Gamma-Glutamyltransferase Increased Hallucination, Auditory Head Banging Lower Respiratory Tract Infection Malaise Rash Date:02/21/05ISR Number: 4588197-4Report Type:Expedited (15-DaCompany Report #FI-GLAXOSMITHKLINE-B0371981A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Lamictal PS Glaxosmithkline ORAL 100MG Per day Initial or Prolonged Neutropenic Sepsis Abilify SS ORAL 30MG Per day Platelet Count Decreased Levozin SS ORAL 600MG Per day Red Blood Cell Count Gaviscon C Glaxosmithkline ORAL 30ML per day Decreased Temesta C ORAL 4MG per day Vitamin D C ORAL 10MG per day Ativan C INTRAMUSCULAR 2MGML As required Tenox C ORAL 20MG Per day 22-Feb-2006 08:31 AM Page: 690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4588464-4Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12780466 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Other Feeling Abnormal Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Insomnia Imovane C Personality Disorder Date:02/22/05ISR Number: 4588469-3Report Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-12856894 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myeloid Maturation Arrest Abilify PS Otsuka Initial or Prolonged Neutropenia Pharmaceutical Neutropenic Sepsis Company, Ltd. ORAL 2 YR Platelet Count Decreased Lamictal SS Levomepromazine SS Gaviscon C Temesta C Vitamin B C Ativan C INTRAMUSCULAR Temazepam C Date:02/22/05ISR Number: 4588474-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12859518 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Abilify Tabs 15 Mg PS Otsuka Hospitalization - Disorientation Pharmaceutical Initial or Prolonged Dizziness Company, Ltd. 1 DAY Date:02/22/05ISR Number: 4588738-7Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12856647 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Abilify PS Otsuka Hospitalization - Coma Pharmaceutical Initial or Prolonged Insomnia Company, Ltd. Other Suicide Attempt Promethazine SS Sinemet C Bristol-Myers Squibb Company INTRAVENOUS dd 125 mg ivm Normison C INTRAVENOUS 10 mg ivm; dd 20 mg night Acenocoumarol C Fraxiparine C Lormetazepam C Date:02/22/05ISR Number: 4588741-7Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12856845 Age:30 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Compartment Syndrome Insomnia Negative Thoughts Restlessness 22-Feb-2006 08:31 AM Page: 691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. 15 mg 29-Oct-04 to 03-Dec-04; 30 mg 03-Dec-04 to 09-Dec-04 42 DAY Olanzapine SS 'till 15-Nov-04 5 mg; then 15-Nov-04 to 22-Nov-04, Oxazepam SS Date:02/22/05ISR Number: 4588742-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12857330 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify PS Otsuka Fall Pharmaceutical Fatigue Company, Ltd. Feeling Hot Abilify SS Otsuka Loss Of Consciousness Pharmaceutical Company, Ltd. Lamictal C Date:02/22/05ISR Number: 4588825-3Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12854402 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL Clonazepam C Date:02/22/05ISR Number: 4591036-9Report Type:Direct Company Report #CTU 240949E Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Aripiprazole PS ORAL 10 MG DAILY Initial or Prolonged Phosphokinase Increased ORAL Hypertension Aspirin C Norvasc C Labetalol C Ditropan C Effexor C Tylenol C Colace C 22-Feb-2006 08:31 AM Page: 692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4591063-1Report Type:Direct Company Report #CTU 240944 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS ORAL QD ORAL Date:02/22/05ISR Number: 4592528-9Report Type:Expedited (15-DaCompany Report #2005023545 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Consumer Nardil Initial or Prolonged Anxiety (Phenelzine Sulfate) PS ORAL 45 MG (15 MG, Other Depression Suicidal 1 IN 1 D), Dry Mouth ORAL Muscle Rigidity Quetiapin Fumarate Pharmaceutical Product (Quetiapine Complaint Fumarate) SS ORAL 50 MG (50 MG, Tremor 1 IN 1 D), Vision Blurred ORAL Ariprazole (Aripiprazole) SS ORAL 10 MG (10 MG, 1 IN 1 D), ORAL Lithium (Lithium) C Date:02/23/05ISR Number: 4589697-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12832473 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Abilify PS Otsuka Hospitalization - Dystonia Pharmaceutical Initial or Prolonged Headache Company, Ltd. ORAL 7 DAY Other Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 DAY Venlafaxine Hcl C ORAL Propranolol C Diclofenac C ORAL Lansoprazole C ORAL Zopiclone C ORAL Buspirone C Remedeine C Date:02/23/05ISR Number: 4589698-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749180 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Blinded: Initial or Prolonged Renal Failure Aripiprazole PS Otsuka Other Therapeutic Agent Pharmaceutical Toxicity Company, Ltd. ORAL 15 to 30 mg 6 DAY Blinded: Lithium SS ORAL 900 to 1200 mg 6 DAY Blinded: Placebo SS ORAL 300 or 15 mg 6 DAY Clonidine SS ORAL 22-Feb-2006 08:31 AM Page: 693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lipitor C ORAL Lotensin C ORAL Seroquel C ORAL Folic Acid C ORAL Aspirin C ORAL Lorazepam C ORAL 1mg 18-Oct-04 to 20-Oct-04 and on 23-Oct-04, 2mg 25-Oct-04 Date:02/23/05ISR Number: 4589699-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12860284 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Drooling Company, Ltd. Dysarthria Glucotrol C Os-Cal C Clonazepam C Trazodone Hcl C Apothecon Miacalcin C Date:02/23/05ISR Number: 4589705-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12749024 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hyperhidrosis Pharmaceutical Malaise Company, Ltd. ORAL Dose stopped on 22-Oct-04; dec to 7.5 mg/day on 24-Oct-04; Effexor C Rivotril C Nozinan I ORAL Date:02/23/05ISR Number: 4595105-9Report Type:Expedited (15-DaCompany Report #HQWYE480223AUG04 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anorectal Agenesis Health Effexor Xr Caesarean Section Professional (Venlafaxine Congenital Anomaly Company Hydrochloride, Drug Exposure During Representative Capsule, Extended Pregnancy Release) PS TRANSPLACENTAL 450 MG 1X EPR Electroconvulsive Therapy 1 DAY, Meningomyelocele TRANSPLACENTA Premature Baby L Abilify (Aripiprazole) SS TRANSPLACENTAL 15 MG 1X PER 1 DAY, TRANSPLACENTA L; 20 MG 1X PER 1 DAY, Ambien (Zolpidem 22-Feb-2006 08:31 AM Page: 694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) SS TRANSPLACENTAL 20 MG 1X PER 1 DAY, TRANSPLACENTA L Ativan (Lorazepam, Tablet) SS SEE IMAG Gabitril (Tiagabine Hydrochloride) SS TRANSPLACENTAL 12 MG 1X PER 1 DAY, TRANSPLACENTA L Klonopin (Clonazepam) SS TRANSPLACENTAL 2 MG 1X PER 1 DAY, TRANSPLACENTA L Remeron (Mirtazapine) SS TRANSPLACENTAL 45 MG 1X PER 1 DAY, TRANSPLACENTA L; 60 MG 1X PER 1 DAY, Date:02/23/05ISR Number: 4595685-3Report Type:Direct Company Report #CTU 241230 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Aripiprazole PS 30 MG QD 1 MON Chlorpromazine SS Date:02/24/05ISR Number: 4590464-5Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12874301 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Abilify PS Otsuka Pharmaceutical Company, Ltd. Morphine SS Chlorpromazine SS Benzodiazepines SS Date:02/24/05ISR Number: 4590467-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12845723 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Abilify PS Otsuka Malaise Pharmaceutical Nausea Company, Ltd. ORAL Buspirone C Wellbutrin Sr C Ambien C 5-10 mg at bedtime as needed 22-Feb-2006 08:31 AM Page: 695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4590481-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12726261 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/25/05ISR Number: 4591031-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12868170 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Abilify PS Otsuka Tachycardia Pharmaceutical Company, Ltd. ORAL 5 mg/day 27-Jan-05, incr to 10 mg/day 30-Jan-05, Clozapine C 300 mg 15-Jan-05, 200 mg 02-Feb-05, 150 mg Beloc-Zok Mite C Date:02/28/05ISR Number: 4592220-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12414009 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592221-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12573390 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Pain Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose: 7.5 mg/day; restarted 1 year later at 2.5 mg/day Sertraline C Oxcarbazepine C Modafinil C Omega-3 C Bupropion C Date:02/28/05ISR Number: 4592222-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12663480 Age:69 YR Gender:Female I/FU:F Outcome PT Abnormal Dreams Confusional State Irritability 22-Feb-2006 08:31 AM Page: 696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tension Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor Xr C Synthroid C Triamterene + Hctz C Detrol C Verapamil Er C Coral Calcium C Vitamin B Complex C Vitamin C C Flaxseed Oil C Prempro C Date:02/28/05ISR Number: 4592223-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12664843 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Memory Impairment Pharmaceutical Nausea Company, Ltd. ORAL 30 mg/day Nervousness from Jul-03 Pain to Aug-03. Restlessness Restarted @ Weight Decreased 15 mg/day in Seroquel C Buspar C Bristol-Myers Squibb Company Artane C Glucovance C Bristol-Myers Squibb Company Prozac C Valium C Nexium C Lithium C Vicodin C Crestor C Ultram C Tylenol #4 C Prevacid C Date:02/28/05ISR Number: 4592224-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12667846 Age:4 DEC Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify Tabs 15 Mg PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. ORAL Increased to 30 mg/day in Apr-2004. Depakote C Wellbutrin C Klonopin C 22-Feb-2006 08:31 AM Page: 697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592225-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12679916 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Pepcid Ac C Prenatal Vitamins C Date:02/28/05ISR Number: 4592226-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12700704 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL decreased to 15 mg/day on 16-Sep-2004 Depakote C qhs child continued on Depakote ER 1 gm daily Ddavp C Metformin Hcl C Bristol-Myers Squibb Company Date:02/28/05ISR Number: 4592227-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12705851 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592228-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12711719 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Cardiac Arrest Pharmaceutical Chills Company, Ltd. ORAL 1 DAY Dizziness Lexapro C Extrasystoles Loss Of Consciousness Sinus Arrhythmia Syncope Date:02/28/05ISR Number: 4592229-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12713665 Age:9 YR Gender:Male I/FU:F Outcome PT Emotional Disorder Flatulence Somnolence 22-Feb-2006 08:31 AM Page: 698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2.5 mg/day:Apr, interrupted: Aug-04, 2.5 every other Date:02/28/05ISR Number: 4592230-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12722732 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Abilify Tabs 15 Mg PS Otsuka Increased Pharmaceutical Blood Cholesterol Company, Ltd. ORAL tapered to Increased 7.5 mg/day, Blood Triglycerides then Increased discontinued 193 DAY Nocturia Depakote C ORAL Lithium C Decreased to 300 mg 1 tablet 2 times/day on 15-Sep-2004, Qvar C Albuterol C Gemfibrozil C Date:02/28/05ISR Number: 4592231-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12731584 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Fall Pharmaceutical Syncope Company, Ltd. ORAL 10 to 15 mg/day 2 WK Date:02/28/05ISR Number: 4592232-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12733150 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Abilify PS Otsuka Initial or Prolonged Bronchitis Acute Pharmaceutical Other Pancreatitis Acute Company, Ltd. ORAL Initiated 5 Sinus Bradycardia mg/day Apr-04, inc to 10 mg/day Apr-04, inc 6 MON Trazodone Hcl C Apothecon ORAL 300-600 mg oral qhs Mirtazapine C ORAL Qhs Lorazepam C ORAL Detrol C Isosorbide Mononitrate C 22-Feb-2006 08:31 AM Page: 699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Plavix C Regulatory Health Authority South Africa Aspirin C Quinine Sulfate C Lexapro C Prilosec C Vioxx C ORAL Date:02/28/05ISR Number: 4592233-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12736567 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL dose reduced to 7.5 mg/day 29-May-2004; pt left treatment 6 DAY Seroquel C 25 mg daily at HS; d/c 29-May-2004; resumed (date not provided) Lexapro C Date:02/28/05ISR Number: 4592234-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12738357 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glossodynia Abilify PS Otsuka Swollen Tongue Pharmaceutical Tongue Disorder Company, Ltd. ORAL From 15-Aug-2004 to 05-Sep-2004, interupted 86 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL From 15-Aug-2004 to 05-Sep-2004, interupted 86 DAY Seroquel C Lexapro C Wellbutrin Sr C Depakote C Date:02/28/05ISR Number: 4592235-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12738530 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Abilify PS Otsuka Initial or Prolonged Heart Rate Increased Pharmaceutical Company, Ltd. ORAL Wellbutrin C 22-Feb-2006 08:31 AM Page: 700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Date:02/28/05ISR Number: 4592236-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12740130 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Effect Abilify PS Otsuka Initial or Prolonged Overdose Pharmaceutical Suicide Attempt Company, Ltd. ORAL Lexapro C Decreased to 5 mg/day "recently" Date:02/28/05ISR Number: 4592237-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12743803 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Abilify PS Otsuka Gait Disturbance Pharmaceutical Company, Ltd. ORAL Decreased to 5 mg/day Lexapro C Buspar C Bristol-Myers Squibb Company Date:02/28/05ISR Number: 4592238-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12745865 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 25 mg/day Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 25 mg/day Neurontin C Strattera C Date:02/28/05ISR Number: 4592239-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12747374 Age:5 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Insomnia Pharmaceutical Muscle Twitching Company, Ltd. ORAL Date:02/28/05ISR Number: 4592240-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749479 Age:65 YR Gender:Male I/FU:F Outcome PT Accidental Overdose Confusional State Dizziness Medication Error 22-Feb-2006 08:31 AM Page: 701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage increased on 10-Nov-2004 Amiodarone C Hydrochlorothiazide C Protonix C Aspirin C Colace C Date:02/28/05ISR Number: 4592241-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12753984 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 10 mg/day several years ago; decreased to Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated 10 mg/day several years ago; decreased to Accuretic C Atrovent C Albuterol C Allopurinol C Zyrtec C Lipitor C Diazepam C Neurontin C Prozac C Date:02/28/05ISR Number: 4592242-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12754230 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 10 Mg PS Otsuka Agitation Pharmaceutical Back Pain Company, Ltd. ORAL Initiated at Cystitis 5 mg/day with Dysarthria varying doses Gastrointestinal Pain up to 15 Psychotic Disorder mg/day and Viral Infection Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day with varying doses up to 15 22-Feb-2006 08:31 AM Page: 702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg/day and Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day with varying doses up to 15 mg/day and Date:02/28/05ISR Number: 4592243-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12754248 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 20 Mg PS Otsuka Dyskinesia Pharmaceutical Hepatic Enzyme Increased Company, Ltd. ORAL 3 WK Tremor Date:02/28/05ISR Number: 4592244-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12754370 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 5 Mg PS Otsuka Food Craving Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Tegretol C Lorazepam C Date:02/28/05ISR Number: 4592245-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12754800 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592246-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12754826 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Date:02/28/05ISR Number: 4592247-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12755369 Age:63 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592248-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12755401 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify PS Otsuka Dysphasia Pharmaceutical Company, Ltd. ORAL 1 MIN Trileptal C Topamax C Lexapro C Date:02/28/05ISR Number: 4592249-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12755427 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 WK Lamictal C dose taken alternating days (AD) Seroquel C Date:02/28/05ISR Number: 4592250-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12755971 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Abilify PS Otsuka Cholelithiasis Pharmaceutical Constipation Company, Ltd. ORAL 15 mg/day Viral Infection initiated in Weight Decreased Oct-03; inc to 30 mg/day on 26-Apr-04. Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day initiated in Oct-03; inc to 30 mg/day on 26-Apr-04. Lithium C Wellbutrin C ORAL Date:02/28/05ISR Number: 4592251-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12757407 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 to 6 months duration 22-Feb-2006 08:31 AM Page: 704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592252-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12757514 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Reduced to 15 mg/day in Nov-2004. Concerta SS ORAL Lexapro C ORAL Date:02/28/05ISR Number: 4592253-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12757571 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Bradykinesia Pharmaceutical Hyperhidrosis Company, Ltd. ORAL 2 WK Nausea Paranoia Date:02/28/05ISR Number: 4592254-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12758231 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Phlebitis Abilify PS Otsuka Pharmaceutical Company, Ltd. Taken for 3-4 months 3 MON Klonopin C Lexapro C Trileptal C Zocor C Date:02/28/05ISR Number: 4592255-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12758520 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Abilify PS Otsuka Pharmaceutical Company, Ltd. Adderall C Paxil C Date:02/28/05ISR Number: 4592256-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12758546 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592257-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12758561 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592258-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12758652 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592259-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12758942 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify PS Otsuka Initial or Prolonged Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592260-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12759932 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Oedema Peripheral Pharmaceutical Pain In Extremity Company, Ltd. ORAL Aygestin C Klonopin C Mysoline C Levoxyl C Levsinex C Premarin C Slow Fe C Synalar C Date:02/28/05ISR Number: 4592261-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12760450 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Nortriptyline C Topamax C Date:02/28/05ISR Number: 4592262-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12760492 Age:32 YR Gender:Male I/FU:I Outcome PT Drug Ineffective Feeling Abnormal 22-Feb-2006 08:31 AM Page: 706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Prescribed Overdose Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Paxil C Cholesterol Medication C Date:02/28/05ISR Number: 4592263-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12760575 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592264-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12760583 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592265-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12761052 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify Tabs 5 Mg PS Otsuka Tremor Pharmaceutical Weight Decreased Company, Ltd. ORAL 7 DAY Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 DAY Date:02/28/05ISR Number: 4592266-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12761292 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swollen Tongue Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 MON Date:02/28/05ISR Number: 4592267-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12761326 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592268-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12761417 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592269-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12762068 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592270-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12762175 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Akinesia Pharmaceutical Constipation Company, Ltd. ORAL 17 DAY Formication Lorazepam C Mania Restlessness Date:02/28/05ISR Number: 4592271-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12762274 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify PS Otsuka Constipation Pharmaceutical Weight Decreased Company, Ltd. ORAL Ritalin C Date:02/28/05ISR Number: 4592272-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12762357 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Abilify PS Otsuka Pharmaceutical Company, Ltd. Decreased to 15 mg/day Date:02/28/05ISR Number: 4592273-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12764189 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial tx started in Feb-03. Exact dates and if tx continues Lamictal C 22-Feb-2006 08:31 AM Page: 708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Gabitril C Neurontin C Lorazepam C Date:02/28/05ISR Number: 4592274-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12764205 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 5 mg/day from 13-Oct-04, increased to 7.5 mg/day on 04-Nov-04 Neurontin C Sonata C Date:02/28/05ISR Number: 4592275-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12764288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Impulsive Behaviour Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592276-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12764965 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Oral Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Lithium C Date:02/28/05ISR Number: 4592277-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12765343 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592278-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12765640 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Yawning Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK Antidepressant C 22-Feb-2006 08:31 AM Page: 709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592279-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12765673 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592280-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12766077 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Aripiprazole PS Otsuka Initial or Prolonged Treatment Noncompliance Pharmaceutical Company, Ltd. Clozapine SS ORAL 50-600 mg/day, stopped and restarted. The patient Date:02/28/05ISR Number: 4592281-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12766135 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify PS Otsuka Mood Altered Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592282-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12766960 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592283-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12767265 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 5 Mg PS Otsuka Feeling Jittery Pharmaceutical Obsessive-Compulsive Company, Ltd. ORAL Started on Disorder 2.5 mg/day, titrated to 5 mg/day Date:02/28/05ISR Number: 4592284-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12767687 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Actonel C Evista C 22-Feb-2006 08:31 AM Page: 710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592285-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12768420 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. Glucophage C Bristol-Myers Squibb Company Glyburide C Sandoz Inc. (Geneva Pharm Tech) Estraderm Patch C TRANSDERMAL K-Dur C Darvon Compound C Coreg C Lanoxin C Lasix C Zaroxolyn C Pravachol C Bristol-Myers Squibb Company Levothyroxine C Lisinopril C Date:02/28/05ISR Number: 4592286-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12768891 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Abilify PS Otsuka Haemorrhage Pharmaceutical Overdose Company, Ltd. Suicide Attempt Abilify SS Otsuka Pharmaceutical Company, Ltd. Trazodone Hcl SS Apothecon Ssri SS Date:02/28/05ISR Number: 4592287-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12769501 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Initial dose not reported. Captopril C Sandoz Inc. (Geneva Pharm, Inc)(Novartis) Detrol C Calcium C Micronase C Topamax C Vitamin E C Plavix C Regulatory Health Authority South Africa Cylert C Multivitamin C Zoloft C Dulcolax C Synthroid C 22-Feb-2006 08:31 AM Page: 711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fosamax C Date:02/28/05ISR Number: 4592288-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12769618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Abilify PS Otsuka Initial or Prolonged Parkinsonism Pharmaceutical Company, Ltd. Aricept SS Date:02/28/05ISR Number: 4592289-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12771093 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592290-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772380 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Fear Pharmaceutical Insomnia Company, Ltd. ORAL Initiated at Paranoia 7.5 mg/day on Tremor 30-Oct-04, increased to 15 mg/day Lithium C Blood Pressure Medication C Risperdal C Date:02/28/05ISR Number: 4592291-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772539 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Pollakiuria Pharmaceutical Company, Ltd. ORAL 1 YR Lexapro C Wellbutrin C 1 YR Zoloft C 2 YR Date:02/28/05ISR Number: 4592292-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772570 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592293-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772588 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Joint Stiffness Pharmaceutical Musculoskeletal Stiffness Company, Ltd. ORAL 2 WK Tongue Disorder Date:02/28/05ISR Number: 4592294-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772596 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592295-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772612 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 10 Mg PS Otsuka Dyskinesia Oesophageal Pharmaceutical Panic Attack Company, Ltd. ORAL Patient also Weight Decreased took 15 mg/day 1 MON Tegretol C Klonopin C Seroquel C Date:02/28/05ISR Number: 4592296-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12773081 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify PS Otsuka Chest Pain Pharmaceutical Dizziness Company, Ltd. Fatigue Date:02/28/05ISR Number: 4592297-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12773164 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592298-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12773289 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592299-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12773792 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Palpitations Pharmaceutical Company, Ltd. ORAL 5 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 5 DAY Zyprexa SS Lithium C Date:02/28/05ISR Number: 4592300-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12775037 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify PS Otsuka Initial or Prolonged Fall Pharmaceutical Polytraumatism Company, Ltd. ORAL Clozapine C 4 YR Seroquel C 4 YR Paxil C 4 YR Date:02/28/05ISR Number: 4592301-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12775243 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592302-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12775342 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 429 DAY Effexor Xr C ORAL Neurontin C ORAL Mavik C Date:02/28/05ISR Number: 4592303-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12776928 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Zyprexa C 22-Feb-2006 08:31 AM Page: 714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592304-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12778403 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Fluoxetine C Bupropion C Date:02/28/05ISR Number: 4592305-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12778908 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cystitis Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Buspar C Bristol-Myers Squibb Company Klonopin C Date:02/28/05ISR Number: 4592306-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12779351 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Abilify Tabs 10 Mg PS Otsuka Hallucination, Auditory Pharmaceutical Weight Decreased Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C 5 YR Seroquel C Diazepam C Trazodone Hcl Tabs C Apothecon Baclofen C Tricor C Lipitor C Avandamet C Glucophage Xr Tabs C Bristol-Myers Squibb Company Hctz C Naproxen C Advair C Singulair C Glucotrol C Date:02/28/05ISR Number: 4592307-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12779450 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 12.5 mg/day, then 15 mg/day. Doxycycline C 22-Feb-2006 08:31 AM Page: 715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592308-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781274 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Deja Vu Pharmaceutical Delusion Company, Ltd. ORAL Increased to Drug Ineffective 30 mg/day on Psychotic Disorder 30-Nov-2004; then 20 mg (date not Depakote C Prolixin C Apothecon INTRAMUSCULAR Benadryl C Ativan C Date:02/28/05ISR Number: 4592309-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781308 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothyroidism Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 10 mg Sep-2004; then increased to 22.5 mg/day Date:02/28/05ISR Number: 4592310-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781340 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Drug Interaction Company, Ltd. ORAL Initiated at 1 mg/twice daily, increased to 2.5 mg/twice Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 1 mg/twice daily, increased to 2.5 mg/twice Folic Acid C Enteric Coated Aspirin C Magnesium C Iron C Klonopin C Clonidine C Mecamylamine C Lamictal C Topamax C 22-Feb-2006 08:31 AM Page: 716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592311-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781399 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cough Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL started 5 mg twice/day; then 10 mg in morning and 5 mg in 4 WK Date:02/28/05ISR Number: 4592312-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781407 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Hallucination Pharmaceutical Insomnia Company, Ltd. ORAL Mood Swings Xanax C Panic Attack Paxil C Restlessness Ambien C Prevacid C Sonata C Allegra-D C Benadryl C Date:02/28/05ISR Number: 4592313-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781480 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Abilify Tabs 10 Mg PS Otsuka Swelling Face Pharmaceutical Vomiting Company, Ltd. ORAL 10 mg every morning (qam) and 5 mg (qhs) every night orally Date:02/28/05ISR Number: 4592314-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781845 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592315-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12782702 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Abilify PS Otsuka Lethargy Pharmaceutical Company, Ltd. ORAL 1 YR Luvox C 22-Feb-2006 08:31 AM Page: 717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592316-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12783791 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Retching Pharmaceutical Vomiting Company, Ltd. ORAL 1 MON Celexa C Lipitor C Prempro C Date:02/28/05ISR Number: 4592317-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12783858 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 3 DAY Antidepressant C Date:02/28/05ISR Number: 4592318-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12783890 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Lethargy Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592319-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785291 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Twin Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592320-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785374 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Hypersensitivity Pharmaceutical Tremor Company, Ltd. ORAL 1 DAY Wheezing Seroquel C Date:02/28/05ISR Number: 4592321-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785382 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Risperdal SS 22-Feb-2006 08:31 AM Page: 718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592322-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Onychorrhexis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592323-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785796 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592324-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785994 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592325-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12786760 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Haldol C INTRAVENOUS Valium C INTRAVENOUS Date:02/28/05ISR Number: 4592326-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12788568 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592327-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12789087 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592328-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12789160 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Tenderness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592329-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12789871 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Terror Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 YR Strattera C 2 YR Neurontin C 2 YR Date:02/28/05ISR Number: 4592330-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12790044 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Abilify PS Otsuka Initial or Prolonged Pancreatitis Pharmaceutical Company, Ltd. ORAL Wellbutrin C Date:02/28/05ISR Number: 4592331-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12790499 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592332-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12791125 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Strattera C 2 YR Date:02/28/05ISR Number: 4592333-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12791489 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 6 DAY 22-Feb-2006 08:31 AM Page: 720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592334-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12791695 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Abilify Tabs 5 Mg PS Otsuka Myalgia Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Paxil C Wellbutrin Xl C Date:02/28/05ISR Number: 4592335-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12791711 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Abilify PS Otsuka Feeling Hot Pharmaceutical Feeling Jittery Company, Ltd. Nervousness Glucophage C Bristol-Myers Squibb Oral Discomfort Company Sensory Disturbance Insuline C Tremor Flaxseed Oil C Aspirin C Calcium + Vitamin D C Date:02/28/05ISR Number: 4592336-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12791745 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Abilify PS Otsuka Psychomotor Hyperactivity Pharmaceutical Soliloquy Company, Ltd. ORAL Depakote C Prozac C Haloperidol C Lorazepam C Diphenhydramine C Lisinopril C Glipizide C Gemfibrozil C Date:02/28/05ISR Number: 4592337-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12792099 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 WK Ativan C Benadryl C Levoxyl C 22-Feb-2006 08:31 AM Page: 721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592338-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12792107 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphasia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 7 WK Concerta C ORAL Date:02/28/05ISR Number: 4592339-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12793147 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Remeron C Date:02/28/05ISR Number: 4592340-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12793386 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose ranged from 15 to 30 mg/day. 17 DAY Clozapine SS ORAL Dose ranged from 25 mg/twice daily up to 400 mg/day, Clozapine SS ORAL Dose ranged from 25 mg/twice daily up to 400 mg/day, Zyprexa SS ORAL Dose ranged from 10 to 20 mg/day 28 DAY Losartan C Docusate Sodium C Ferrous Sulfate C Trazodone Hcl C Apothecon Chlorpromazine C Venlafaxine Hcl C Mirtazapine C Date:02/28/05ISR Number: 4592341-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12793857 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Abilify Tabs 5 Mg PS Otsuka Hypothyroidism Pharmaceutical Orthostatic Proteinuria Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Focalin C 66 DAY 22-Feb-2006 08:31 AM Page: 722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592342-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12793923 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Motor Dysfunction Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592343-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12793956 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 10 Mg PS Otsuka Restlessness Pharmaceutical Company, Ltd. ORAL 1 WK Date:02/28/05ISR Number: 4592344-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12794731 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Trazodone Hcl C Apothecon Date:02/28/05ISR Number: 4592345-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12794988 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Cogentin C Date:02/28/05ISR Number: 4592346-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12795803 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Pain In Extremity Company, Ltd. 1 YR Date:02/28/05ISR Number: 4592347-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12796173 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Micturition Urgency Abilify PS Otsuka Pollakiuria Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592348-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12796280 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:02/28/05ISR Number: 4592349-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12796306 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Adverse Event Abilify PS Otsuka White Blood Cell Count Pharmaceutical Decreased Company, Ltd. Wellbutrin C Date:02/28/05ISR Number: 4592350-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12796611 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ejaculation Disorder Abilify PS Otsuka Urinary Retention Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592351-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12797148 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Abilify PS Otsuka Hospitalization - Syndrome Pharmaceutical Initial or Prolonged Renal Failure Company, Ltd. ORAL Interrupted Other Respiratory Distress on 06-Nov-2004 when the patient was Haldol SS Clozaril SS Interrupted on 06-Nov-2004 when the patient was Pavulon C 1 DAY Diprivan C 1 DAY Geodon C 1 DAY Dantrium C 1 DAY Date:02/28/05ISR Number: 4592352-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12797395 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Date:02/28/05ISR Number: 4592353-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12797429 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. ORAL 4 WK Crestor C 22-Feb-2006 08:31 AM Page: 724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592354-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12797619 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592355-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12797692 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify PS Otsuka Feeling Hot Pharmaceutical Restless Legs Syndrome Company, Ltd. ORAL 7 DAY Seroquel C Lexapro C Strattera C Date:02/28/05ISR Number: 4592356-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12799383 Age:6 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592357-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12800397 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Adderall C Ritalin C Date:02/28/05ISR Number: 4592358-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12800553 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592359-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12801452 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. 5 MON Strattera C 22-Feb-2006 08:31 AM Page: 725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592360-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12801791 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 7 DAY Simvastatin SS ORAL Felodipine C ORAL Lisinopril C ORAL Terazosin C ORAL Haloperidol C Lorazepam C Date:02/28/05ISR Number: 4592361-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12802781 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592362-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12802823 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Road Traffic Accident Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592363-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12803805 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592364-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12804647 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592365-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12804662 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592366-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12804696 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Foreign Body Aspiration Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592367-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12808119 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 10 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592368-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12808150 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Agitation Pharmaceutical Mood Altered Company, Ltd. ORAL 3 mg; gradually increased to 5 mg, 10 mg, 15 mg; then Strattera C 80 mg reduced to 40 mg as of 28-Dec-04. Zoloft C Zyprexa C 2.5 mg - 2 to 3 times daily (only recently discontinued) Date:02/28/05ISR Number: 4592369-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12808929 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Movement Disorder Abilify Tabs 5 Mg PS Otsuka Eyelid Function Disorder Pharmaceutical Company, Ltd. ORAL Zoloft C Date:02/28/05ISR Number: 4592370-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12809489 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592371-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12809570 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Propranolol C Lithium C Date:02/28/05ISR Number: 4592372-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12810917 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592373-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12811592 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592374-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12812715 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Abilify PS Otsuka Initial or Prolonged Weight Decreased Pharmaceutical Company, Ltd. ORAL 8 DAY Eskalith Cr C Xanax C Zoloft C Neurontin C Date:02/28/05ISR Number: 4592375-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12812723 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysmenorrhoea Abilify PS Otsuka Fatigue Pharmaceutical Metrorrhagia Company, Ltd. ORAL 5 WK Klonopin C Topamax C Synthroid C Loestrin C Date:02/28/05ISR Number: 4592376-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12814653 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Reduced to 15 22-Feb-2006 08:31 AM Page: 728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg/day Depakote C Date:02/28/05ISR Number: 4592377-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12815304 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prescribed Overdose Abilify Tabs 30 Mg PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL Wellbutrin Xl C Vistaril C Ambien C Synthroid C Cogentin C Protonix C Date:02/28/05ISR Number: 4592378-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12816385 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Olanzapine C Glyburide C Sandoz Inc. (Geneva Pharm Tech) Ranitidine C Lithium C Depakote C Date:02/28/05ISR Number: 4592379-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12817250 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592380-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12818779 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592381-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12818795 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Abilify Tabs 10 Mg PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL Risperdal C Cogentin C Zoloft C 22-Feb-2006 08:31 AM Page: 729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Depakote C Date:02/28/05ISR Number: 4592382-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12818803 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Terror Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Sinemet C Bristol-Myers Squibb Company Atarax C Date:02/28/05ISR Number: 4592383-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12819264 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 1 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 DAY Trileptal C Lexapro C Zyprexa C Date:02/28/05ISR Number: 4592384-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12819710 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 3 WK Date:02/28/05ISR Number: 4592385-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12819744 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 DAY Date:02/28/05ISR Number: 4592386-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12820346 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Abilify PS Otsuka Pharmaceutical Company, Ltd. Lithium C Effexor C 22-Feb-2006 08:31 AM Page: 730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592387-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12820965 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Wellbutrin Sr C Depakote C Clonazepam C Thyroid C Date:02/28/05ISR Number: 4592388-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12822227 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Celxa C Valium C Date:02/28/05ISR Number: 4592389-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12822417 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myoclonus Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Dilantin C Date:02/28/05ISR Number: 4592390-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12822516 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aspartate Abilify Tabs 5 Mg PS Otsuka Aminotransferase Pharmaceutical Increased Company, Ltd. ORAL 62 DAY Blood Amylase Increased Benadryl C Date:02/28/05ISR Number: 4592391-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12824033 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592392-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12824082 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592393-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12824223 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592394-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12824249 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Red Blood Cell Count Pharmaceutical Increased Company, Ltd. ORAL Initiated 10 Vomiting mg/day on 17-Aug-04; inc to 15 mg/day on Seroquel C Risperdal C Benadryl C Date:02/28/05ISR Number: 4592395-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12824355 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592396-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12824363 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Anger Pharmaceutical Company, Ltd. ORAL 11 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 11 DAY Risperdal C Date:02/28/05ISR Number: 4592397-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825121 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592398-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825139 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Date:02/28/05ISR Number: 4592399-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825147 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592400-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825154 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592401-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825162 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592402-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825170 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592403-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825188 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592404-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825196 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592405-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825204 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592406-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825600 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Klonopin C Topamax C Claritin D C Flonase C Multivitamins C Vitamin B Complex C Vitamin E C Date:02/28/05ISR Number: 4592407-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825915 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify PS Otsuka Initial or Prolonged Dizziness Pharmaceutical Fall Company, Ltd. Lower Limb Fracture Clozapine SS ORAL White Blood Cell Count Neurontin C Increased Eskalith C Date:02/28/05ISR Number: 4592408-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12827499 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Dystonia Pharmaceutical Emotional Distress Company, Ltd. ORAL Initiated at Feeling Abnormal 5 mg/day; Respiratory Rate after 7 days, Increased increased to Tongue Disorder 10 mg and Seroquel C Zyprexa C Effexor C 22-Feb-2006 08:31 AM Page: 734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592409-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12827937 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. ORAL 90-100 mg/day Divalproex Sodium C Date:02/28/05ISR Number: 4592410-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12829081 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify PS Otsuka Mania Pharmaceutical Company, Ltd. ORAL Zoloft C Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL Paxil I Date:02/28/05ISR Number: 4592411-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12829719 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Depakote C Date:02/28/05ISR Number: 4592412-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12830014 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Abilify Tabs 15 Mg PS Otsuka Medication Error Pharmaceutical No Adverse Effect Company, Ltd. ORAL 1 DAY Date:02/28/05ISR Number: 4592413-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12830048 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592414-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12830071 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592415-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12830329 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Constipation Pharmaceutical Company, Ltd. ORAL 1 MON Zyprexa C Neurontin C Wellbutrin C Date:02/28/05ISR Number: 4592416-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12831475 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Frequent Bowel Movements Abilify PS Otsuka Hallucination, Visual Pharmaceutical Company, Ltd. Zoloft C Verapamil C Pravastatine C Bristol-Myers Squibb Company Zantac C Date:02/28/05ISR Number: 4592417-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12831848 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify Tabs 30 Mg PS Otsuka Apathy Pharmaceutical Asthenia Company, Ltd. ORAL 30 mg 2 X Balance Disorder day; then Blood Glucose Increased reduced to 15 Bradyphrenia mg 1 X day at Disturbance In Attention night. Drooling Abilify Tabs 30 Mg SS Otsuka Dry Mouth Pharmaceutical Dystonia Company, Ltd. ORAL 30 mg 2 X Feeling Abnormal day; then Feeling Jittery reduced to 15 Headache mg 1 X day at Insomnia night. Memory Impairment Lipitor C Movement Disorder Insulin C Muscle Spasms Muscle Twitching Musculoskeletal Stiffness Pollakiuria Prescribed Overdose Restlessness Thirst Vision Blurred Weight Increased 22-Feb-2006 08:31 AM Page: 736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592418-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12832408 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592419-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12833075 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592420-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12833091 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592421-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12833117 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Psychomotor Hyperactivity Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592422-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12833570 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592423-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12833893 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Hallucination Pharmaceutical Nervousness Company, Ltd. ORAL 5 mg/day Nightmare started 7 Tinnitus weeks ago; dose increased to Benicar C Estrol C 22-Feb-2006 08:31 AM Page: 737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592424-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12834636 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Initiated at 5 mg/day, dose increased by 5 mg/week up Abilify SS Otsuka Pharmaceutical Company, Ltd. Initiated at 5 mg/day, dose increased by 5 mg/week up Paxil Cr C Date:02/28/05ISR Number: 4592425-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12834685 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Seroquel C Lamictal C Date:02/28/05ISR Number: 4592426-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12835583 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Psychomotor Hyperactivity Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592427-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12835591 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Psychomotor Hyperactivity Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592428-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12836193 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL at night Date:02/28/05ISR Number: 4592429-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12836706 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592430-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12837332 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. ORAL 2 DAY Date:02/28/05ISR Number: 4592431-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12837357 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Depakote C Altace C Glyburide C Sandoz Inc. (Geneva Pharm Tech) Ginseng C Vitamin C C Calcium C Magnesium C Date:02/28/05ISR Number: 4592432-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12837373 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 15 mg/day after approx 6 months 1 YR Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 15 mg/day after approx 6 months 1 YR Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 15 mg/day after approx 6 months 1 YR Depakote C Evista C 22-Feb-2006 08:31 AM Page: 739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Date:02/28/05ISR Number: 4592433-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12837753 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. ORAL Increased to 45 mg/day 2 YR Lorazepam C Lamictal C Date:02/28/05ISR Number: 4592434-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12838256 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Sedation Pharmaceutical Tremor Company, Ltd. ORAL Vision Blurred Date:02/28/05ISR Number: 4592435-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12839700 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592436-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12840013 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592437-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12840757 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL Date:02/28/05ISR Number: 4592438-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12841136 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Abilify SS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 1 YR Wellbutrin Xl C Date:02/28/05ISR Number: 4592439-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12841185 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592440-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12841771 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyporeflexia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592441-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12842068 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592442-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12842100 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 DAY Date:02/28/05ISR Number: 4592443-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12842365 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Date:02/28/05ISR Number: 4592444-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12842944 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592445-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12843017 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Trismus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 4 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 4 DAY Adderall Xr C Clonidine C Date:02/28/05ISR Number: 4592446-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12845038 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592447-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12847752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Confusional State Pharmaceutical Dementia Company, Ltd. Insomnia Date:02/28/05ISR Number: 4592448-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12848149 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyporeflexia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:02/28/05ISR Number: 4592449-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12853735 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Confusional State Pharmaceutical Dementia Company, Ltd. Insomnia Date:02/28/05ISR Number: 4592737-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12863460 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 10 DAY 22-Feb-2006 08:31 AM Page: 742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592807-5Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12869244 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Suicidal Ideation Pharmaceutical Treatment Noncompliance Company, Ltd. Oxazepam C Temazepam C Promethazine C Haloperidol C Date:02/28/05ISR Number: 4592808-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12867859 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Extrasystoles Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Date:02/28/05ISR Number: 4592813-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12813481 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Abilify PS Otsuka Initial or Prolonged Asthenia Pharmaceutical Other Blood Glucose Increased Company, Ltd. ORAL Coma Haldol C Lethargy Cogentin C Pollakiuria Pyrexia Thirst Urine Output Increased Date:02/28/05ISR Number: 4592815-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12874954 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Aripiprazole PS Otsuka Drug Interaction Pharmaceutical Company, Ltd. ORAL Atenolol C Sandoz Inc. (Geneva Pharm Tech) Antihypertensive I Alcohol I Date:02/28/05ISR Number: 4592816-6Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12868394 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify PS Otsuka Glossitis Pharmaceutical Swollen Tongue Company, Ltd. 15 mg Tongue Disorder 12-Nov-04 to 29-Nov-04; 30 mg 29-Nov-04 to cont. Promethazine C 22-Feb-2006 08:31 AM Page: 743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Artane C Buspirone C Zoloft C Pariet C Date:02/28/05ISR Number: 4592986-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12874954 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Aripiprazole PS Otsuka Completed Suicide Pharmaceutical Death Company, Ltd. ORAL Drug Interaction Atenolol C Sandoz Inc. (Geneva Pharm Tech) Antihypertensive I Alcohol I Date:03/01/05ISR Number: 4598785-7Report Type:Direct Company Report #CTU 241694 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Aripiprazole 15 Mg PS ORAL 15 MG HS ORAL Topiramate C Lithium C Omeprazole C Date:03/02/05ISR Number: 4595823-2Report Type:Expedited (15-DaCompany Report #PHEH2005US01693 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Exelon PS Novartis Sector: Drug Ineffective Pharma Abilify SS ORAL 10 UNK, QD Alprazolam C Date:03/03/05ISR Number: 4597625-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12870275 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Clozapine SS Date:03/03/05ISR Number: 4598491-9Report Type:Direct Company Report #CTU 241975 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Abilify Headache -Aripiprazole- Heart Rate Increased 5mg Insomnia Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 1/2 TABLET Nausea ONCE A DAY Vomiting ORAL Seroquel C Depakote C 22-Feb-2006 08:31 AM Page: 744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Date:03/03/05ISR Number: 4599604-5Report Type:Expedited (15-DaCompany Report #DSA_24882_2004 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Health Ativan PS 0.5 MG QID Initial or Prolonged Drug Exposure During Professional Ativan SS 1 MG QID Congenital Anomaly Pregnancy Effexor Xr SS 450 MG QD Required Pregnancy Remeron SS 45 MG QD Intervention to Remeron SS 60 MG QHS Prevent Permanent Abilify SS 15 MG QD Impairment/Damage Abilify SS 20 MG QHS Ambien SS 20 MG QD Gabitril SS 12 MG QD Klonopin SS 2 MG QD Date:03/04/05ISR Number: 4598700-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12874145 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Poisoning Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:03/04/05ISR Number: 4598701-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12877221 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Aripiprazole PS Otsuka Initial or Prolonged Increased Pharmaceutical Other Depressive Symptom Company, Ltd. Drug Interaction Aripiprazole I Otsuka Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. Psychotic Disorder Fluoxetine I Serotonin Syndrome Date:03/04/05ISR Number: 4598752-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12841565 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Intentional Self-Injury Pharmaceutical Company, Ltd. ORAL 10 mg/day from Sep-2004 to 24-Nov-2004; inc to 15 Risperidone C ORAL 2002, route/dose unknown, IM unknown, 2 mg 2003 to 22-Feb-2006 08:31 AM Page: 745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/05ISR Number: 4598757-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12827564 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthopnoea Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Lorazepam C Propranolol C Antabuse C Phenelzine C Zopiclone C NOCTE Date:03/04/05ISR Number: 4598780-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12859518 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Reaction Abilify Tabs 15 Mg PS Otsuka Hospitalization - Pharmaceutical Initial or Prolonged Company, Ltd. 1 DAY Date:03/04/05ISR Number: 4598829-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12770947 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Abilify PS Otsuka Other Death Pharmaceutical Delusion Company, Ltd. ORAL Drug Level Increased Clozapine SS ORAL Fear Lexapro C ORAL Paranoia Klonopin C Treatment Noncompliance Benztropine C White Blood Cell Count Lisinopril C Increased Humulin C Metformin Hcl C Bristol-Myers Squibb Company Levoxyl C Ortho-Novum C Nitroglycerine C Atenolol C Sandoz Inc. (Geneva Pharm Tech) Date:03/07/05ISR Number: 4600142-1Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12856647 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Abilify PS Otsuka Hospitalization - Drug Ineffective Pharmaceutical Initial or Prolonged Insomnia Company, Ltd. Other Suicide Attempt Promethazine SS Sinemet C Bristol-Myers Squibb Company INTRAVENOUS dd 125 mg ivm Normison C INTRAVENOUS 10 mg ivm; dd 20 mg night Acenocoumarol C Fraxiparine C Lormetazepam C 22-Feb-2006 08:31 AM Page: 746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4602642-7Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12856845 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Compartment Syndrome Pharmaceutical Insomnia Company, Ltd. 15 mg Memory Impairment 29-Oct-04 to Negative Thoughts 03-Dec-04; 30 Oedema Peripheral mg 03-Dec-04 Overdose to 09-Dec-04 42 DAY Pain In Extremity Olanzapine SS 'till Restlessness 15-Nov-04 5 Suicide Attempt mg; then 15-Nov-04 to 22-Nov-04, Oxazepam SS Date:03/09/05ISR Number: 4602643-9Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12877668 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Abilify PS Otsuka Initial or Prolonged Aminotransferase Pharmaceutical Increased Company, Ltd. ORAL Blood Creatinine Sobril C Increased Blood Pressure Abnormal C-Reactive Protein Increased Hallucination, Auditory Insomnia Muscle Spasms Musculoskeletal Stiffness Tachycardia White Blood Cell Count Increased Date:03/09/05ISR Number: 4602942-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12652228 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Convulsion Company, Ltd. ORAL 14 DAY Hyponatraemia Cipramil C ORAL 10 mg, then Loss Of Consciousness 20 mg since Muscle Spasms 24-Jun-04;25- Polydipsia Jun-04, 30 mg Vomiting Risperdal C ORAL reduced on 16-Jul-04 Tavor C ORAL 0.5 mg tid, since 24-Jun-04 0.5 mg qid 07-Jun-04 Co-Diovan C valsartan 80 mg/hctz 12.5 mg 17-Jun-04 22-Feb-2006 08:31 AM Page: 747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4602944-4Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12731931 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Abilify PS Otsuka Initial or Prolonged Thermal Burn Pharmaceutical Company, Ltd. ORAL Initiated at 30 mg/day, decreased to 15 mg/day on 24-Sep-2004 Promethazine C Date:03/09/05ISR Number: 4602950-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12709887 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Dizziness Company, Ltd. ORAL Headache Valproic Acid C Insomnia Amisulpride C increased to Nausea 800 mg and stopped in a tapering manner on Trimipramine C Levothyroxine C Dose = 100 ug Date:03/09/05ISR Number: 4602952-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12736500 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Abilify PS Otsuka Initial or Prolonged Communication Disorder Pharmaceutical Tremor Company, Ltd. ORAL Metoprolol C ORAL Metformin Hcl C Bristol-Myers Squibb Company ORAL Isosorbide Mononitrate C Date:03/11/05ISR Number: 4605051-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12844189 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Abilify PS Otsuka Other Increased Pharmaceutical Aspartate Company, Ltd. 15 mg Aminotransferase 28-Jul-04; 30 Increased mg 09-Nov-04 Blood Cholesterol Simvastatin C 10 mg since Increased 01-Mar-04 ; Blood Triglycerides then Increased up-titrated Cardiac Failure to 20 mg on Gamma-Glutamyltransferase Increased 22-Feb-2006 08:31 AM Page: 748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/05ISR Number: 4607351-6Report Type:Direct Company Report #CTU 242796E Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Abilify 5 Chest Pain Mg/-Bristol Myers Tachycardia Squibb PS Bristol Myers Squibb 5 MG/DAY Date:03/11/05ISR Number: 4608214-2Report Type:Expedited (15-DaCompany Report #2005UW03421 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Hallucination Study PO Psychotic Disorder Health Aripiprazole SS Schizophrenia Professional Other Date:03/14/05ISR Number: 4607065-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12886594 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Systolic Abilify PS Otsuka Decreased Pharmaceutical Cardiovascular Disorder Company, Ltd. ORAL 15-30 mg/day Fall Loss Of Consciousness Date:03/14/05ISR Number: 4607068-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12882791 Age:8 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Other Depression Pharmaceutical Mania Company, Ltd. Neuroleptic Malignant Syndrome Date:03/14/05ISR Number: 4607075-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12883096 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Abilify Tabs 10 Mg PS Otsuka Hospitalization - Pyrexia Pharmaceutical Initial or Prolonged White Blood Cell Count Company, Ltd. ORAL Increased Ativan C Ambien C Norvasc C Date:03/14/05ISR Number: 4607487-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12856522 Age:3 DEC Gender:Male I/FU:F Outcome PT Hospitalization - Blood Cholesterol Initial or Prolonged Increased Other Blood Triglycerides Increased 22-Feb-2006 08:31 AM Page: 749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Report Source Product Role Manufacturer Route Dose Duration Low Density Lipoprotein Abilify PS Otsuka Increased Pharmaceutical Weight Increased Company, Ltd. ORAL 205 DAY Zocor C Lithium C Insulin C Risperidone C Date:03/14/05ISR Number: 4607771-XReport Type:Expedited (15-DaCompany Report #12799326 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Amoxicillin PS Glaxosmithkline ORAL 500MG Per day 2 DAY Initial or Prolonged Emotional Distress Abilify SS ORAL 15MG Per day 3 MON General Physical Health Flupenthixol Deterioration Decanoate C INTRAMUSCULAR 200MG Weekly Hallucination, Auditory Lorazepam C ORAL .5MG Per day Head Banging Liver Function Test Abnormal Lower Respiratory Tract Infection Malaise Rash Date:03/15/05ISR Number: 4608518-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12887386 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Abilify PS Otsuka Mania Pharmaceutical Company, Ltd. ORAL Date:03/15/05ISR Number: 4608551-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12808713 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify PS Otsuka Feeling Abnormal Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Nasal Congestion Prilosec C Suicidal Ideation Benadryl C Thinking Abnormal Vitamin E C Weight Decreased Calcium C Multivitamins C Date:03/15/05ISR Number: 4610941-8Report Type:Direct Company Report #CTU 243256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify PS Bms 5MG PILL 2 Initial or Prolonged Feeling Abnormal TIME DAILY Other Somnolence Strattera SS 125 MG PILL ONCE DAILY 22-Feb-2006 08:31 AM Page: 750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/05ISR Number: 4610944-3Report Type:Direct Company Report #CTU 243258 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affective Disorder Abilify PS Otsuka Anxiety Pharmaceutical ORAL 1 DAY ORAL Disturbance In Attention Wellbutrin C Dyspnoea Headache Insomnia Nausea Throat Tightness Date:03/15/05ISR Number: 4611437-XReport Type:Direct Company Report #CTU 243213 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Abilify 10mg Tab PS Date:03/16/05ISR Number: 4609659-7Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12796033 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Spontaneous Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL 45 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 45 DAY Date:03/16/05ISR Number: 4610119-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12587051 Age:3 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Extrapyramidal Disorder Pharmaceutical Flat Affect Company, Ltd. ORAL 1/2 of a 15 Lethargy mg tablet; Medication Error approximately Mental Impairment 11.9 mg ingested. Date:03/17/05ISR Number: 4611368-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12888996 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Abilify PS Otsuka Initial or Prolonged Pancreatitis Pharmaceutical Company, Ltd. increased to 15 mg in Dec-2004. Wellbutrin Xl C Trazodone Hcl Tabs C Apothecon HS 22-Feb-2006 08:31 AM Page: 751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/05ISR Number: 4612534-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12899621 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Abilify Tabs 15 Mg PS Otsuka Other Phosphokinase Increased Pharmaceutical Cardiac Arrest Company, Ltd. ORAL Electrocardiogram St Lepticur SS Segment Elevation Rivotril SS Fall Tercian SS ORAL Hyperkalaemia Lipanthyl SS ORAL Malaise Risperdal SS Psychomotor Hyperactivity Respiratory Arrest Date:03/18/05ISR Number: 4614889-4Report Type:Direct Company Report #CTU 243697 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grandiosity Cymbaltar 60 Mg Initial or Prolonged Hypomania Daily PS 60 MG PO Inappropriate Affect DAILY Pressure Of Speech Abilify 20 Mg SS ORAL 20 MG PO HS Speech Disorder Depakote C Date:03/21/05ISR Number: 4613521-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12892287 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oropharyngeal Spasm Abilify PS Otsuka Torticollis Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Atosil SS ORAL Diazepam C ORAL Marcumar C YR Marcumar C YR Concor C Rytmonorm C Date:03/21/05ISR Number: 4613729-7Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0374714A Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Paracetamol PS Glaxosmithkline ORAL 16TAB per day Initial or Prolonged Drug Abuser Abilify SS ORAL 15MG per day Intentional Overdose Depakote SS ORAL 16TAB per day International Normalised Fluoxetine SS ORAL 10TAB per day Ratio Increased Multiple Drug Overdose Accidental Suicide Attempt 22-Feb-2006 08:31 AM Page: 752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4613979-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12874954 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Chlorpromazine PS ORAL 100 mg; then Other Drowning 150 mg Drug Ineffective 24-Nov-04 to Drug Interaction 07-Jan-05 Atenolol C Sandoz Inc. (Geneva Pharm Tech) Procyclidine C ORAL Abilify I Otsuka Pharmaceutical Company, Ltd. ORAL Antihypertensive I Alcohol I Date:03/21/05ISR Number: 4615876-2Report Type:Expedited (15-DaCompany Report #GXKR2005DE00760 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Fluoxetine (Ngx) Nuclear Magnetic Literature (Fluoxetine) PS SEE IMAGE Resonance Imaging Health Risperidone Abnormal Professional (Ngx)(Risperidone) SS 2 MG, QD Oculogyration Other Aripiprazole(Aripipr azole) SS 15 MG, QD, Olanzapine (Olanzapine0 C Date:03/21/05ISR Number: 4616227-XReport Type:Expedited (15-DaCompany Report #2004-123632-NL Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Remeron /Net/ PS ORAL 45 MG QD; Initial or Prolonged Condition Aggravated Professional ORAL Disability Insomnia Abilify /Usa/ SS ORAL 10 MG DAILY; Required Oedema Genital ORAL Intervention to Pain Prevent Permanent Post Procedural Impairment/Damage Complication Priapism Suicidal Ideation Tremor Date:03/22/05ISR Number: 4614769-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12899258 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Abilify PS Otsuka Initial or Prolonged Increased Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Loss Of Consciousness Clozaril SS ORAL progr. decr. Neuroleptic Malignant from 550 mg Syndrome on Psychotic Disorder 27-Jan-2004 Rebound Effect to 200 mg; Valium C 22-Feb-2006 08:31 AM Page: 753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/05ISR Number: 4614786-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12892477 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Abilify Tabs 5 Mg PS Otsuka Hormone Increased Pharmaceutical Company, Ltd. ORAL Initiated at 2.5 mg/day, increased to 5 mg/day about 1 1/2 Clonidine C Vitamins C Date:03/22/05ISR Number: 4614791-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12860284 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Drooling Company, Ltd. ORAL Dysarthria Glucotrol C Os-Cal C Clonazepam C Trazodone Hcl C Apothecon Miacalcin C Date:03/22/05ISR Number: 4614820-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12840773 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Company, Ltd. ORAL 10 mg 02-Dec-2004, decreased to 5 mg as of 26-Jan-05 Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 10 mg 02-Dec-2004, decreased to 5 mg as of 26-Jan-05 Trazodone Hcl C Apothecon Glucotrol C Miacalcin C Clonazepam C Date:03/22/05ISR Number: 4614822-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12860284 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Drooling Company, Ltd. ORAL Dysarthria Glucotrol C Os-Cal C 22-Feb-2006 08:31 AM Page: 754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Trazodone Hcl C Apothecon Miacalcin C Date:03/23/05ISR Number: 4616125-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050300079 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS OROPHARINGEAL Death Risperdal SS OROPHARINGEAL Pulmonary Embolism Abilify SS OROPHARINGEAL Pyrexia Rivotril SS OROPHARINGEAL Respiratory Arrest Lepticur SS OROPHARINGEAL Lipanthyl SS OROPHARINGEAL Tercian SS OROPHARINGEAL Date:03/23/05ISR Number: 4616149-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12828570 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify PS Otsuka Fatigue Pharmaceutical Hallucination, Auditory Company, Ltd. Menorrhagia Epilim SS Musculoskeletal Stiffness Nausea Pituitary Tumour Psychotic Disorder Somnolence Date:03/23/05ISR Number: 4616153-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12844205 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acarodermatitis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 153 DAY Concor C Date:03/23/05ISR Number: 4617103-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-398349 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Rivotril PS Roche ORAL 3 DAY Phosphokinase Increased Risperdal SS ORAL 895 DAY Cardiac Arrest Lipanthyl SS ORAL Electrocardiogram St-T Tercian SS ORAL 15 DAY Segment Elevation Abilify SS ORAL 18 DAY Feeling Abnormal Lepticur SS ORAL 9 DAY Hyperkalaemia Psychomotor Hyperactivity Respiratory Arrest 22-Feb-2006 08:31 AM Page: 755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4617205-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE01429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex / Clozaril Dyspnoea (Clozapine) PS Novartis Sector: Pharma ORAL Nebilet SS Abilify SS Date:03/23/05ISR Number: 4617299-9Report Type:Expedited (15-DaCompany Report #05-01-0119 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozapine Tablets - Initial or Prolonged Fall Professional Iax Pharmaceuticals, Hypercalcaemia Other Inc. PS Ivax Renal Failure Pharmaceuticals, Thinking Abnormal Inc. ORAL 250MG QD ORAL Abilify SS 15MG AM Lamictal C Colace C Date:03/24/05ISR Number: 4617906-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12898516 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Abilify PS Otsuka Vasculitis Pharmaceutical Company, Ltd. 10 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 MON Strattera C 10 MON Celexa C 10 MON Date:03/25/05ISR Number: 4619018-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12901054 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:03/28/05ISR Number: 4620008-0Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12758843 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify Tabs PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Myositis Company, Ltd. ORAL 2 WK 22-Feb-2006 08:31 AM Page: 756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/05ISR Number: 4620080-8Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12900825 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Abilify PS Otsuka Initial or Prolonged Fall Pharmaceutical Head Injury Company, Ltd. ORAL Orthostatic Hypotension Syncope Date:03/28/05ISR Number: 4620089-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12899944 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gilbert'S Syndrome Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 10 mg/day, increased to 20 mg/day, discontinued, Lithium C Date:03/28/05ISR Number: 4620091-2Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-12906186 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify PS Otsuka Logorrhoea Pharmaceutical Psychotic Disorder Company, Ltd. ORAL Initiated at 7.5 mg/day 2 MON Dolmatil C Increased to 1600 mg/day Date:03/28/05ISR Number: 4620930-5Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0294600-00 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Depakote Tablets PS ORAL Initial or Prolonged Intentional Overdose Depakote Tablets SS ORAL International Normalised Paracetamol SS ORAL Ratio Increased Paracetamol SS ORAL Psychotic Disorder Fluoxetine Suicide Attempt Hydrochloride SS ORAL Aripiprazole SS ORAL Date:03/28/05ISR Number: 4622639-0Report Type:Direct Company Report #CTU 244473 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Discomfort Zoloft 25 Mg X 4 Dyspnoea Days PS ORAL PO 25 MG Nausea DAILY 4 DAY Vomiting Abilify 15 Mg Bid SS 15 MG BID 3 WK 22-Feb-2006 08:31 AM Page: 757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/05ISR Number: 4622678-XReport Type:Direct Company Report #CTU 244488 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Abilify 5 Mg Increased -Bristol-Myers Cogwheel Rigidity Squibb PS ORAL 5 MG PO Q DAY Confusional State Abilify 5 Mg SS ORAL 2.5 MG PO QD Gait Disturbance PRN Heart Rate Increased Fluoxetine C Tremor Detrol La C Date:03/29/05ISR Number: 4621713-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12882791 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Failure Abilify PS Otsuka Hospitalization - Syndrome Pharmaceutical Initial or Prolonged Depression Company, Ltd. Other Mania Medication Error Neuroleptic Malignant Syndrome Parkinsonism Date:03/29/05ISR Number: 4622777-2Report Type:Direct Company Report #CTU 244507E Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperosmolar Abilify PS ORAL P.O. Coma Hyperglycaemia Loss Of Consciousness Date:04/01/05ISR Number: 4624885-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12906244 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Abilify PS Otsuka Musculoskeletal Stiffness Pharmaceutical Speech Disorder Company, Ltd. ORAL Tongue Paralysis Quetiapine C ORAL 25-150-50 mg Lansoprazole C ORAL Date:04/01/05ISR Number: 4625040-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12906269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cardiac Failure Abilify PS Otsuka Congestive Pharmaceutical Company, Ltd. ORAL Temazepam C ORAL Vitamin B Complex C ORAL Thiamine C ORAL Vioxx C 22-Feb-2006 08:31 AM Page: 758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/05ISR Number: 4625045-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12870291 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Abilify PS Otsuka Hospitalization - Abnormal Pharmaceutical Initial or Prolonged Dystonia Company, Ltd. ORAL 1/31/05 5 mg qd; incr to 10 mg on 07-Feb-05; incr to 15 mg Effexor Xr C Seroquel C Klonopin C Wellbutrin Xl C Date:04/01/05ISR Number: 4625183-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12906822 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Agitation Pharmaceutical Convulsion Company, Ltd. 7.5 mg am and Irritability 7.5 mg pm Self Injurious Behaviour Abilify SS Otsuka Pharmaceutical Company, Ltd. 7.5 mg am and 7.5 mg pm Topamax C Strattera C Date:04/01/05ISR Number: 4625570-XReport Type:Expedited (15-DaCompany Report #CH-MERCK-0503USA05173 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Prinzide PS Merck & Co., Inc ORAL 22 DAY Initial or Prolonged Cerebrovascular Prinivil SS ORAL 246 DAY Insufficiency Abilify SS ORAL 7 DAY Difficulty In Walking Abilify SS ORAL 21 DAY Dizziness Postural Abilify SS ORAL 15 DAY Drug Ineffective Topiramate SS ORAL 3 DAY Eye Movement Disorder Topiramate SS ORAL 35 DAY Heart Rate Increased Topiramate SS ORAL 4 DAY Topiramate SS ORAL 0 DAY Amlodipine Besylate SS ORAL Pantoprazole SS ORAL 184 DAY Date:04/04/05ISR Number: 4625843-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12154464 Age:2 YR Gender:Female I/FU:F Outcome PT Life-Threatening Accidental Overdose Hospitalization - Coordination Abnormal Initial or Prolonged Loss Of Consciousness Other Sinus Tachycardia Somnolence Tremor Vomiting White Blood Cell Count 22-Feb-2006 08:31 AM Page: 759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:04/04/05ISR Number: 4626008-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050300079 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal PS OROPHARINGEAL Cardiac Arrest Risperdal SS OROPHARINGEAL Death Abilify SS OROPHARINGEAL Fall Lepticur SS OROPHARINGEAL Psychomotor Hyperactivity Tercian SS OROPHARINGEAL Pulmonary Embolism Lipanthyl SS OROPHARINGEAL Pyrexia Rivotril SS OROPHARINGEAL Respiratory Arrest Risperdal SS OROPHARINGEAL Suicidal Ideation Sulfarlem C Prozac C Date:04/05/05ISR Number: 4626834-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12911988 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Abilify PS Otsuka Initial or Prolonged Hypotension Pharmaceutical Loss Of Consciousness Company, Ltd. Pyrexia Neurontin C Baclofen C Lexapro C Keppra C Inderal La C Orap C Imipramine C Date:04/05/05ISR Number: 4626835-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749180 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Encephalopathy Blinded: Renal Failure Aripiprazole PS Otsuka Therapeutic Agent Pharmaceutical Toxicity Company, Ltd. ORAL 15 to 30 mg 6 DAY Blinded: Lithium SS ORAL 900 to 1200 mg 6 DAY Blinded: Placebo SS ORAL 300 or 15 mg 6 DAY Clonidine SS ORAL Lipitor C ORAL Lotensin C ORAL Seroquel C ORAL Folic Acid C ORAL Aspirin C ORAL Lorazepam C ORAL 1mg 18-Oct-04 to 20-Oct-04 and on 23-Oct-04, 22-Feb-2006 08:31 AM Page: 760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 2mg 25-Oct-04 Date:04/05/05ISR Number: 4626836-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12899621 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Abilify Tabs 15 Mg PS Otsuka Other Phosphokinase Increased Pharmaceutical Cardiac Arrest Company, Ltd. ORAL Electrocardiogram St Lepticur SS Segment Elevation Rivotril SS Fall Tercian SS ORAL Hyperkalaemia Lipanthyl SS ORAL Malaise Risperdal SS Psychomotor Hyperactivity Respiratory Arrest Date:04/05/05ISR Number: 4628990-2Report Type:Direct Company Report #CTU 245300 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS DAILY Drug Interaction Zoloft SS DAILY Paradoxical Drug Reaction Clozaril SS Suicidal Ideation Date:04/05/05ISR Number: 4657379-5Report Type:Periodic Company Report #2004043469 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 Dysarthria Health MG, 2 IN 1 Dyspnoea Professional D), ORAL Facial Palsy Aripiprazole Hypersensitivity (Aripiprazole) SS ORAL 10 MG (10 MG, Speech Disorder 1 IN 1 D), Swollen Tongue ORAL Tardive Dyskinesia Escitalopram Trismus (Escitalopram) C Atomoxetine Hydrochloride (Atomoxetine Hydrochloride) C Clonazepam (Clonazepam) C Pantoprazole (Pantoprazole) C Date:04/07/05ISR Number: 4630919-8Report Type:Direct Company Report #CTU 245632 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Aripiprazole PS ORAL 2.5 MG PO Initial or Prolonged Dysstasia DAILY Dystonia Stratera C Facial Palsy 22-Feb-2006 08:31 AM Page: 761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/05ISR Number: 4630346-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12914305 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myopia Abilify Tabs PS Otsuka Visual Acuity Reduced Pharmaceutical Company, Ltd. 4 WK Amoxicillin C Apothecon Date:04/08/05ISR Number: 4630742-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-398349 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Rivotril PS Roche ORAL 3 DAY Phosphokinase Increased Risperdal SS ORAL 895 DAY Cardiac Arrest Lipanthyl SS ORAL Electrocardiogram St Tercian SS ORAL 15 DAY Segment Elevation Abilify SS ORAL 18 DAY Feeling Abnormal Lepticur SS ORAL 9 DAY Hyperkalaemia Psychomotor Hyperactivity Respiratory Arrest Date:04/11/05ISR Number: 4632049-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12881066 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Dec-04, 5 mg; dosage increased slowly to 15 mg which Date:04/11/05ISR Number: 4632052-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12915138 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Abilify PS Otsuka Initial or Prolonged Fall Pharmaceutical Hypercalcaemia Company, Ltd. Psychiatric Symptom Clozapine SS ORAL Renal Failure Lamictal C ORAL Colace C ORAL Date:04/11/05ISR Number: 4632193-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12864567 Age:45 WK Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Aripiprazole PS Otsuka Initial or Prolonged Femur Fracture Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4632773-7Report Type:Expedited (15-DaCompany Report #KR-BRISTOL-MYERS SQUIBB COMPANY-12919031 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:04/12/05ISR Number: 4633044-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12916904 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Loss Of Consciousness Pharmaceutical Nausea Company, Ltd. Supraventricular Abilify SS Otsuka Tachycardia Pharmaceutical Company, Ltd. Depakote C Lamictal C Antabuse C Lexapro C Date:04/12/05ISR Number: 4633459-5Report Type:Expedited (15-DaCompany Report #HQWYE651604APR05 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congenital Anomaly Health Efexor Xr Drug Exposure During Professional (Venlafaxine Pregnancy Other Hydrochloride, Heart Disease Congenital Capsule, Extended Hydronephrosis Release) PS ORAL 75 MG 1X PER Kidney Small 1 DAY Limb Malformation Abilify (Aripiprazole, ) SS ORAL 15 MG 1X PER 1 DAY 65 DAY Efexor (Venlfaxine Hydrochloride, Tablet) SS Olanzapine (Olanzapine) C Haloperidol (Haloperidol) C Dicloxacillin (Dicloxacillin) C Alprazolam (Alprazolam) C Date:04/13/05ISR Number: 4633901-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12890174 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Abilify PS Otsuka Chest Pain Pharmaceutical Tachycardia Company, Ltd. 22-Feb-2006 08:31 AM Page: 763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/05ISR Number: 4633928-8Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12854402 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Clonazepam C Date:04/13/05ISR Number: 4634189-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12918694 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Senna C Movelat C Lactulose C Perindopril C ORAL Aspirin C ORAL Simvastatin C ORAL Detrusitol C ORAL Beclomethasone C RESPIRATORY (INHALATION) Adizem C ORAL Salbutamol C RESPIRATORY (INHALATION) Date:04/13/05ISR Number: 4634684-XReport Type:Direct Company Report #CTU 246072 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Abilify PS ORAL 10 MG; 1/2 Initial or Prolonged Dysaesthesia QAM, 1 QHS, Dyskinesia PO Hemiparesis Neck Pain Sedation Tremor Date:04/15/05ISR Number: 4635899-7Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12922951 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 15 mg/day; after a few days, titrated to Abilify SS Otsuka Pharmaceutical Company, Ltd. Initiated at 15 mg/day; after a few days, titrated to 22-Feb-2006 08:31 AM Page: 764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Escitalopram C Clordesmethyldiazepa m C Date:04/15/05ISR Number: 4635912-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12906822 Age:8 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Agitation Pharmaceutical Irritability Company, Ltd. 7.5 mg am and Self Injurious Behaviour 7.5 mg pm Abilify SS Otsuka Pharmaceutical Company, Ltd. 7.5 mg am and 7.5 mg pm Topamax C Strattera C Date:04/18/05ISR Number: 4637482-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12931341 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperosmolar Abilify PS Otsuka Coma Pharmaceutical Company, Ltd. Date:04/18/05ISR Number: 4637484-XReport Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12925178 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify Tabs 15 Mg PS Otsuka Coordination Abnormal Pharmaceutical Drug Interaction Company, Ltd. ORAL Insomnia Hair Product Muscle Spasms (Non-Shampoo) I Nausea Nervous System Disorder Vomiting Weight Decreased Date:04/18/05ISR Number: 4637826-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12898516 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Abilify PS Otsuka Crohn'S Disease Pharmaceutical Red Blood Cell Company, Ltd. 10 MON Sedimentation Rate Abilify SS Otsuka Increased Pharmaceutical Vasculitis Company, Ltd. 10 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 MON Strattera C 10 MON Celexa C 10 MON 22-Feb-2006 08:31 AM Page: 765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/05ISR Number: 4637830-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12925129 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Aripiprazole PS Otsuka Hospitalization - Asphyxia Pharmaceutical Initial or Prolonged Weight Increased Company, Ltd. UNKNOWN Zyprexa SS ORAL Zopiclone C UNKNOWN Date:04/18/05ISR Number: 4638819-4Report Type:Direct Company Report #CTU 246456 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tongue Disorder Abilify PS Bristol-Meyers Intervention to Tremor Squibb ORAL 7.5 MG DAILY Prevent Permanent ORAL Impairment/Damage Vistaril C Date:04/18/05ISR Number: 4638870-4Report Type:Direct Company Report #CTU 246439 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Abilify PS PARENTERAL 15 QHS PARENTERAL Date:04/19/05ISR Number: 4638778-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926317 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:04/19/05ISR Number: 4638812-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12906269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cardiac Failure Abilify PS Otsuka Other Congestive Pharmaceutical Insomnia Company, Ltd. ORAL Paranoia Temazepam C ORAL Vitamin B Complex C ORAL Thiamine C ORAL Vioxx C Date:04/19/05ISR Number: 4638813-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12892287 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oropharyngeal Spasm Abilify PS Otsuka Torticollis Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Atosil SS ORAL 22-Feb-2006 08:31 AM Page: 766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diazepam C ORAL Marcumar C YR Marcumar C YR Concor C Rytmonorm C Date:04/20/05ISR Number: 4640007-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926713 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Abilify PS Otsuka Initial or Prolonged Hypertension Pharmaceutical Paralysis Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Date:04/20/05ISR Number: 4641558-7Report Type:Expedited (15-DaCompany Report #US_0504115116 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Of Grandeur Study Atomoxetine Initial or Prolonged Treatment Noncompliance Health Hydrochloride PS Professional Aripiprazole SS 20 MG/1 DAY Date:04/22/05ISR Number: 4642232-3Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12900825 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Abilify PS Otsuka Initial or Prolonged Fall Pharmaceutical Head Injury Company, Ltd. ORAL Decreased to Orthostatic Hypotension 15 mg/day Syncope Date:04/22/05ISR Number: 4642555-8Report Type:Expedited (15-DaCompany Report #GR-BRISTOL-MYERS SQUIBB COMPANY-12929592 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Tavor C Nozinan C Efexor C Date:04/22/05ISR Number: 4642558-3Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12932612 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Other Restlessness Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine C Lorazepam C Date:04/22/05ISR Number: 4643807-8Report Type:Direct Company Report #CTU 246931 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Abilify 5mg Tab PS Diphenhydramine Hcl C Lorazepam C Diphenhydramine Elixir C Sodium Fluoride C Omeprazole C Ketorolac Tromethamine C Dorzolamide 2%/Timolol 0.5% C Docusate Sodium C Brimonidine C Milk Of Magnesia C Acetaminophen C Lorazepam C Date:04/25/05ISR Number: 4643652-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE01429 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex / Clozaril Dyspnoea (Clozapine) PS Novartis Sector: Tachycardia Pharma ORAL up to 100mg/day Nebilet SS ORAL 0.5 mg, QD Abilify SS ORAL 25 mg, QD Date:04/25/05ISR Number: 4644927-4Report Type:Expedited (15-DaCompany Report #2005AP000342 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Literature Fluoxetine Initial or Prolonged Increased Health Hydrochloride Oral Drug Interaction Professional Solution PS 20 MG; QD Neuroleptic Malignant Aripiprazole SS 30 MG; QD Syndrome Psychomotor Retardation Date:04/26/05ISR Number: 4644743-3Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12935060 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Aripiprazole PS Otsuka Other General Physical Health Pharmaceutical Deterioration Company, Ltd. Zolpidem C Alprazolam C Pantoprazole C Cetirizine C 22-Feb-2006 08:31 AM Page: 768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diclofenac C Ketotifen C Propranolol C Date:04/26/05ISR Number: 4644771-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12934485 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Porphyria Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:04/26/05ISR Number: 4645101-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12931341 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperosmolar Abilify PS Otsuka Coma Pharmaceutical Company, Ltd. Date:04/27/05ISR Number: 4645981-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12943544 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Impulsive Behaviour Pharmaceutical Company, Ltd. ORAL Date:04/27/05ISR Number: 4646353-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12937082 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:04/28/05ISR Number: 4647713-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939500 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Abilify PS Otsuka Drug Interaction Pharmaceutical Schizophrenia Company, Ltd. ORAL Fluoxetine I Date:04/29/05ISR Number: 4648520-9Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12922951 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 15 mg/day; after a few days, 22-Feb-2006 08:31 AM Page: 769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report titrated to Abilify SS Otsuka Pharmaceutical Company, Ltd. Initiated at 15 mg/day; after a few days, titrated to Escitalopram C Clordesmethyldiazepa m C Date:04/29/05ISR Number: 4648523-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939559 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:04/29/05ISR Number: 4648524-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939500 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Abilify PS Otsuka Drug Interaction Pharmaceutical Schizophrenia Company, Ltd. ORAL Fluoxetine I Date:04/29/05ISR Number: 4648574-XReport Type:Expedited (15-DaCompany Report #HU-BRISTOL-MYERS SQUIBB COMPANY-12938809 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Clonazepam C Procyclidine C Date:04/29/05ISR Number: 4648577-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12808713 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify PS Otsuka Feeling Abnormal Pharmaceutical Hallucination Company, Ltd. ORAL Also reported Hallucination, Auditory as 15 mg/day Nasal Congestion Prilosec C Suicidal Ideation Benadryl C Thinking Abnormal Vitamin E C Weight Decreased Calcium C Multivitamins C 22-Feb-2006 08:31 AM Page: 770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/05ISR Number: 4649221-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12939658 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:04/29/05ISR Number: 4649227-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12870291 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Abilify PS Otsuka Abnormal Pharmaceutical Blood Triglycerides Company, Ltd. ORAL 1/31/05 5 mg Increased qd; incr to Dystonia 10 mg on 07-Feb-05; incr to 15 mg Effexor Xr C Seroquel C Klonopin C Wellbutrin Xl C Date:04/29/05ISR Number: 4650835-5Report Type:Direct Company Report #CTU 247429 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Abilify 5 Mg Po Tabs PS ORAL 1 TAB DAILY 1 YR Initial or Prolonged Non-Insulin-Dependent Trilrptal C Date:05/02/05ISR Number: 4650120-1Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12939450 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL Luvox C Date:05/02/05ISR Number: 4650134-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926317 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Abilify PS Otsuka Respiratory Failure Pharmaceutical Company, Ltd. Zoloft C Klonopin C Sonata C Date:05/02/05ISR Number: 4650152-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12744777 Age:35 YR Gender:Female I/FU:F Outcome PT Other Dizziness Headache 22-Feb-2006 08:31 AM Page: 771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Syncope Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Ziprasidone C ORAL 40 mg BID; then scheduled for reduction on 05-Oct-04. Date:05/03/05ISR Number: 4650717-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12940953 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Aspirin C ORAL Bupropion C ORAL Glyburide C Sandoz Inc. (Geneva Pharm Tech) ORAL Hydrochlorothiazide C ORAL Irbesartan C Bristol-Myers Squibb Company ORAL Levothyroxine C ORAL Metformin Hcl C Bristol-Myers Squibb Company ORAL Olanzapine C ORAL Ranitidine C ORAL Simvastatin C ORAL Triamcinolone Ace Ointment C Apothecon TOPICAL Date:05/03/05ISR Number: 4650838-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12942249 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Carotid Artery Dissection Abilify PS Otsuka Hospitalization - Cerebellar Infarction Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Disability Metformin Hcl C Bristol-Myers Squibb Other Company Date:05/03/05ISR Number: 4650839-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12855540 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Depression Aripiprazole PS Otsuka Other Sedation Pharmaceutical Company, Ltd. ORAL 2 DAY Aspirin C Simvastatin C ORAL Thiamine C Amisulpride C Bisoprolol C ORAL Adcal-D3 C 22-Feb-2006 08:31 AM Page: 772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4651000-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12942223 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify PS Otsuka Drug Interaction Pharmaceutical Muscle Twitching Company, Ltd. ORAL Mirtazapine C Multivitamins C Citalopram I ORAL Date:05/03/05ISR Number: 4651281-0Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12941449 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Other Traumatic Brain Injury Company, Ltd. ORAL Date:05/03/05ISR Number: 4651284-6Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-12854402 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Clonazepam C Date:05/03/05ISR Number: 4654554-0Report Type:Direct Company Report #CTU 247592 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS ORAL 15MG DAILY Initial or Prolonged Cogwheel Rigidity ORAL Movement Disorder Date:05/03/05ISR Number: 4654561-8Report Type:Direct Company Report #CTU 247596 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accommodation Disorder Abilify 10 Mg Hs PS Extrapyramidal Disorder Mental Status Changes Vision Blurred Date:05/03/05ISR Number: 4654599-0Report Type:Direct Company Report #CTU 247606 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Aripiprazole 15mg PS ORAL 15MG QAM Initial or Prolonged Dyspnoea ORAL Insomnia 22-Feb-2006 08:31 AM Page: 773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/05ISR Number: 4652181-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12945036 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Urinary Tract Infection Company, Ltd. ORAL 4 MON Date:05/04/05ISR Number: 4652184-8Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12947198 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Abilify PS Otsuka Pharmaceutical Company, Ltd. Antipsychotic C Benzodiazepines C Date:05/04/05ISR Number: 4652450-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12945432 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:05/05/05ISR Number: 4653734-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12945101 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Aggregation Abilify PS Otsuka Decreased Pharmaceutical Company, Ltd. Date:05/06/05ISR Number: 4654574-6Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-12932612 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Abilify PS Otsuka Other Anxiety Pharmaceutical Completed Suicide Company, Ltd. ORAL Delusion Lorazepam C Hallucination Psychomotor Hyperactivity Restlessness Schizoaffective Disorder Date:05/06/05ISR Number: 4654822-2Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-12947404 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Aripiprazole PS Otsuka Initial or Prolonged Impulsive Behaviour Pharmaceutical Company, Ltd. ORAL 1 MON Seroquel C ORAL Zyprexa C ORAL Diazepam C ORAL 22-Feb-2006 08:31 AM Page: 774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/05ISR Number: 4657568-XReport Type:Expedited (15-DaCompany Report #MK200504-0329-1 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Fluoxetine 20mg Initial or Prolonged Alanine Aminotransferase Health Capsules PS 20 MG, Q D Increased Professional Aripiprazole SS 30 MG, QD Blood Creatine Bupropion C Phosphokinase Increased Risperidone C Cogwheel Rigidity Depression Labile Blood Pressure Masked Facies Musculoskeletal Stiffness Psychomotor Retardation Psychotic Disorder Pyrexia Restlessness Salivary Hypersecretion Tachycardia Tremor Date:05/09/05ISR Number: 4656556-7Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12950507 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Abilify PS Otsuka Antidiuretic Hormone Pharmaceutical Secretion Company, Ltd. ORAL Diuretic C Date:05/09/05ISR Number: 4658663-1Report Type:Expedited (15-DaCompany Report #S05-USA-02250-01 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Consumer Lexapro Hospitalization - Depression (Escitalopram) PS ORAL 20 MG QD PO Initial or Prolonged Drug Ineffective Lithium SS 600 MG QD Mania Lamictal Multiple Drug Overdose (Lamotrigine) SS 50 MG BID Personality Change Abilify Suicide Attempt (Aripiprazole) SS 15 MG QD Weight Increased Seroquel (Quetiapine Fumarate) SS Trazodone SS Date:05/10/05ISR Number: 4657555-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12949863 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myeloid Leukaemia Abilify PS Otsuka Initial or Prolonged Chest Discomfort Pharmaceutical Other Nausea Company, Ltd. Lipitor C 6 MON Cozaar C 6 MON Zoloft C 2 YR Buspar C Bristol-Myers Squibb Company 22-Feb-2006 08:31 AM Page: 775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/05ISR Number: 4658648-5Report Type:Expedited (15-DaCompany Report #2005S1001884 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Treatment Noncompliance Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Abilify SS UNKNOWN 10 MG;QD;UNKNOWN Zoloft SS UNKNOWN 100 MG;QD;UNKNOWN Date:05/13/05ISR Number: 4661208-3Report Type:Expedited (15-DaCompany Report #MX-BRISTOL-MYERS SQUIBB COMPANY-12941480 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Aspartate Pharmaceutical Other Aminotransferase Company, Ltd. ORAL Increased Biperiden C Asthenia Midazolam C Bacteria Urine Identified Blood Creatine Phosphokinase Increased Blood Urea Increased Body Temperature Increased Catatonia Confusional State Coordination Abnormal Dehydration Depressed Level Of Consciousness Gait Disturbance Joint Sprain Muscle Rigidity Neutrophil Count Increased Stupor White Blood Cell Count Increased Date:05/13/05ISR Number: 4661288-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12956777 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 15 Mg PS Otsuka Respiratory Arrest Pharmaceutical Company, Ltd. ORAL Salbutamol C Tropatepine C Prazepam C Amitriptyline C 22-Feb-2006 08:31 AM Page: 776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/05ISR Number: 4661298-8Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12943536 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Psychotic Disorder Abilify PS Otsuka Hospitalization - Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Date:05/13/05ISR Number: 4661300-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12943544 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Agitation Pharmaceutical Condition Aggravated Company, Ltd. ORAL Injury Psychotic Disorder Date:05/13/05ISR Number: 4661799-2Report Type:Expedited (15-DaCompany Report #2005UW07199 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Seroquel PS Zeneca Hospitalization - Depression Pharmaceutical ORAL 3 YR Initial or Prolonged Drug Ineffective Lexapro SS ORAL Intentional Misuse Lithium SS Mania Lamictal SS Multiple Drug Overdose Abilify SS Personality Change Trazodone SS 3 YR Social Avoidant Behaviour Suicide Attempt Weight Increased Date:05/16/05ISR Number: 4662185-1Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12937082 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:05/16/05ISR Number: 4662434-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12914305 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myopia Abilify Tabs PS Otsuka Visual Acuity Reduced Pharmaceutical Company, Ltd. ORAL Interrupted on 28-Mar-2005, re-started on 18-Apr-2005. Amoxicillin C Apothecon 22-Feb-2006 08:31 AM Page: 777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/16/05ISR Number: 4664001-0Report Type:Direct Company Report #CTU 248653 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Disorder Abilify PS 10 MG Adderall Xr SS 10 MG Trileptal C Soma C Vicodin C Mobic C Date:05/16/05ISR Number: 4664323-3Report Type:Direct Company Report #CTU 248597 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Swollen Tongue Abilify PS ORAL 10 MG PO DAILY Lisinopril C Date:05/17/05ISR Number: 4663291-8Report Type:Expedited (15-DaCompany Report #US-KINGPHARMUSA00001-K200500576 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Cytomel Tablets PS King Initial or Prolonged Autoimmune Thyroiditis Pharmaceuticals, Blood Pressure Decreased Inc. ORAL 12.5 mcg, qd Drug Interaction Cytomel Tablets SS King Heart Rate Increased Pharmaceuticals, Irritability Inc. ORAL 25 mcg, qd Lethargy Cytomel Tablets SS King Mood Swings Pharmaceuticals, Overdose Inc. ORAL 37.5 mcg, 1.5 Suicidal Ideation tablet/25mcg qd Cytomel Tablets SS King Pharmaceuticals, Inc. ORAL 25 mcg, qd Cytomel Tablets SS King Pharmaceuticals, Inc. ORAL 12.5 mcg, qd Abilify SS ORAL 10 mg, qd Strattera SS ORAL 18 mg, 2qd Lexapro SS ORAL 30 mg, qd Lexapro SS ORAL 2.5 mg, qd Lexapro SS ORAL 5 mg, qd Lexapro SS ORAL 2.5 mg, qd Klonopin SS ORAL UNK, UNK Date:05/17/05ISR Number: 4663502-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0558030A Age:30 YR Gender:Female I/FU:I Outcome PT Hospitalization - Antisocial Behaviour Initial or Prolonged Depression Drug Ineffective Intentional Misuse Mania Overdose Personality Change 22-Feb-2006 08:31 AM Page: 778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Suicide Attempt Weight Increased Report Source Product Role Manufacturer Route Dose Duration Lamictal PS Glaxosmithkline ORAL Lithium SS Glaxosmithkline UNKNOWN 600MG Per day Lexapro SS ORAL 20MG Per day Abilify SS UNKNOWN 15MG Per day Seroquel SS UNKNOWN Trazodone SS UNKNOWN Date:05/18/05ISR Number: 4664314-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12958765 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus-Like Syndrome Abilify PS Otsuka Pharmaceutical Company, Ltd. Initial tx in the fall of 2004. Discontinued in the spring Clozaril C Date:05/18/05ISR Number: 4664318-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12957809 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Abilify PS Otsuka Initial or Prolonged Abnormal Pharmaceutical Other Feeling Drunk Company, Ltd. Initiated at Muscle Rigidity 2.5 mg/day, inc to 2.5 mg/twice daily, inc to Seroquel C Date:05/18/05ISR Number: 4664329-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12948212 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Depression Abilify PS Otsuka Other Drug Interaction Pharmaceutical Gait Disturbance Company, Ltd. ORAL 15 mg/day Movement Disorder 16-Mar-05; Muscle Rigidity reduced to 10 Tremor mg/day Amisulpride C ORAL Contraceptive C ORAL Escitalopram I ORAL Date:05/18/05ISR Number: 4664477-9Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12935060 Age:71 YR Gender:Female I/FU:F Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Apathy Aripiprazole PS Otsuka Fatigue Pharmaceutical General Physical Health Company, Ltd. Deterioration Zolpidem C Myocardial Infarction Alprazolam C Pantoprazole C Cetirizine C Diclofenac C Ketotifen C Propranolol C Date:05/18/05ISR Number: 4664478-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12959342 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Abilify PS Otsuka Confusional State Pharmaceutical Mental Retardation Company, Ltd. 6 MON Severity Unspecified Date:05/18/05ISR Number: 4664480-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12960688 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Zoloft C Date:05/18/05ISR Number: 4664886-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12931341 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperosmolar Abilify PS Otsuka Other Coma Pharmaceutical Nausea Company, Ltd. ORAL Prescribed Overdose Vomiting Date:05/18/05ISR Number: 4665423-4Report Type:Direct Company Report #CTU 249002 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Aripiprazole 15 Mg PS ORAL 15 MG HS ORAL Ibuprofen C Olanzapine C 22-Feb-2006 08:31 AM Page: 780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/05ISR Number: 4665547-1Report Type:Direct Company Report #CTU 248994E Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Abilify 5 Mg Initial or Prolonged Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 10 MG ONCE DAILY ORAL Asa C Cardizem C Folic Acid C Vitamin E C Vytorin C Nitro C Glucophage C Elavil C Neurontin C Mobic C Tylenol C Zanaflex C Ultram C Zoloft C Zantac C Dulcolax C Date:05/18/05ISR Number: 4666291-7Report Type:Expedited (15-DaCompany Report #S05-UKI-01727-01 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Cipralex Other Movement Disorder Health (Escitalopram) PS ORAL 10 MG QD PO Muscle Rigidity Professional Abilify Tremor Other (Aripirazole) SS ORAL 15 MG QD PO Abilify (Aripirazole) SS ORAL 10 MG QD PO Amisulpride (Amisulpride) C Oral Contraceptives Unspecified C ORAL Date:05/19/05ISR Number: 4666229-2Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12939450 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Disability Syndrome Company, Ltd. ORAL Other Prescribed Overdose Luvox C ORAL Chlorpromazine C Chlorpromazine C Date:05/19/05ISR Number: 4666363-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12879888 Age:9 YR Gender:Male I/FU:F Outcome PT Other Drooling Drug Interaction Dysarthria Dyskinesia 22-Feb-2006 08:31 AM Page: 781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Abnormal Hypokinesia Mydriasis Report Source Product Role Manufacturer Route Dose Duration Pupillary Reflex Impaired Abilify PS Otsuka Speech Disorder Pharmaceutical Vision Blurred Company, Ltd. Concerta C Clonidine C Miralax C Senokot C Date:05/19/05ISR Number: 4666368-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12849527 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Abilify PS Otsuka Initial or Prolonged Blood Pressure Pharmaceutical Other Fluctuation Company, Ltd. ORAL 15 to 20 Feeling Abnormal mg/day Heart Rate Increased Clozapine C ORAL Miosis Haloperidol C ORAL No Therapeutic Response Diazepam C ORAL reduced to as Psychotic Disorder necessary Date:05/19/05ISR Number: 4666483-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12880183 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delusion Abilify Tabs PS Otsuka Disability Drooling Pharmaceutical Other Dysarthria Company, Ltd. ORAL Drug stopped Dyskinesia on the 5th Feeling Abnormal day/held for Hypokinesia 2 days/then Incoherent restarted. Ischaemic Stroke Abilify Tabs SS Otsuka Mydriasis Pharmaceutical Paranoia Company, Ltd. ORAL Drug stopped Pupillary Reflex Impaired on the 5th Vision Blurred day/held for 2 days/then restarted. Concerta C Clonidine C Senokot C Miralax C 3/4 capful twice a day Seroquel C Date:05/19/05ISR Number: 4668516-0Report Type:Expedited (15-DaCompany Report #2005-01660 Age:30 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Other Required Intervention to 22-Feb-2006 08:31 AM Page: 782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Trazodone Drug Ineffective Other Hydrochloride Intentional Misuse (Watson Mania Laboratories)(Trazod Multiple Drug Overdose one Hydrochloride) PS Watson Laboratories ORAL ORAL Off Label Use Lexapro Personality Change (Escitalopram) SS ORAL 20 MG, DAILY, Suicide Attempt ORAL Weight Increased Lithium (Lithium) SS ORAL 600 MG, DAILY, ORAL Lamictal "Glaxo Welcome" SS Glaxo Welcome ORAL 50 MG, BID, ORAL Ariprazole (Apirprazole) SS ORAL 15 MG, DAILY, ORAL Seroquel (Quetiapine Fumarate) SS ORAL ORAL Date:05/20/05ISR Number: 4667373-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12962478 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Anger Pharmaceutical Paranoia Company, Ltd. ORAL Personality Change Psychotic Disorder Date:05/20/05ISR Number: 4667375-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12963989 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Psychotic Disorder Company, Ltd. ORAL Increased to 30 mg/day on 20-Apr-2005 Date:05/23/05ISR Number: 4668580-9Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12941449 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Other Neuroleptic Malignant Company, Ltd. ORAL Syndrome Traumatic Brain Injury 22-Feb-2006 08:31 AM Page: 783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/05ISR Number: 4672451-1Report Type:Expedited (15-DaCompany Report #05-05-0897 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Fluoxetine PS Drug Interaction Other Abilify SS ORAL ORAL Feeling Abnormal Date:05/23/05ISR Number: 4695563-5Report Type:Expedited (15-DaCompany Report #2005PK00842 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel I Zeneca Pharmaceutical ORAL 6 DAY Seroquel I Zeneca Pharmaceutical ORAL 22 DAY Seroquel I Zeneca Pharmaceutical ORAL 13 DAY Seroquel I Zeneca Pharmaceutical ORAL 37 DAY Seroquel I Zeneca Pharmaceutical ORAL Abilify I ORAL 40 DAY Abilify I ORAL Date:05/24/05ISR Number: 4672520-6Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12877668 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hallucination, Auditory Pharmaceutical Insomnia Company, Ltd. ORAL Muscle Spasms Abilify Tabs 15 Mg SS Otsuka Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL Renal Failure Sobril C Tachycardia Panodil C ORAL Treatment Noncompliance Propavan C ORAL White Blood Cell Count Somadril C ORAL Increased Lanzo C ORAL Oxascand C ORAL Date:05/24/05ISR Number: 4672525-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938320 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Abilify PS Otsuka Initial or Prolonged Electrocardiogram Qt Pharmaceutical Other Corrected Interval Company, Ltd. 2 YR Prolonged Celxa C Hypertension Digoxin C Torsade De Pointes Labetalol C Norvasc C 22-Feb-2006 08:31 AM Page: 784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/05ISR Number: 4672715-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12749180 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Encephalopathy Blinded: Renal Failure Aripiprazole PS Otsuka Therapeutic Agent Pharmaceutical Toxicity Company, Ltd. ORAL 15 to 30 mg 6 DAY Blinded: Lithium SS ORAL 900 to 1200 mg 6 DAY Blinded: Placebo SS ORAL 300 or 15 mg 6 DAY Clonidine SS ORAL Lipitor C ORAL Lotensin C ORAL Seroquel C ORAL Folic Acid C ORAL Aspirin C ORAL Lorazepam C ORAL 1mg 18-Oct-04 to 20-Oct-04 and on 23-Oct-04, 2mg 25-Oct-04 Date:05/24/05ISR Number: 4672793-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12965893 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Abilify PS Otsuka Hospitalization - Drug Ineffective Pharmaceutical Initial or Prolonged Intentional Misuse Company, Ltd. Mania Trazodone Hcl SS Apothecon Suicide Attempt Lexapro SS ORAL Weight Increased Lithium SS Lamictal SS Seroquel SS Date:05/24/05ISR Number: 4672795-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12945101 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Abilify PS Otsuka Dysphonia Pharmaceutical Epistaxis Company, Ltd. Fatigue Macrocytosis Palpitations Platelet Aggregation Decreased Psychotic Disorder Sinus Congestion Date:05/24/05ISR Number: 4672901-0Report Type:Expedited (15-DaCompany Report #GXKR2005US01038 Age:43 YR Gender:Male I/FU:I Outcome PT Life-Threatening Akathisia Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Blood Creatine 22-Feb-2006 08:31 AM Page: 785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Cogwheel Rigidity Depression Drug Interaction Report Source Product Role Manufacturer Route Dose Duration Labile Blood Pressure Literature Fluoxetine (Ngx) Masked Facies Health (Fluoxetine) PS 20 MG QD 14 DAY Musculoskeletal Stiffness Professional Aripiprazole (Ngx) Neuroleptic Malignant (Aripiprazole) SS 30 MG QD 14 DAY Syndrome Psychomotor Retardation Psychotic Disorder Pyrexia Restlessness Salivary Hypersecretion Tachycardia Tremor Date:05/25/05ISR Number: 4673258-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12968145 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:05/25/05ISR Number: 4673308-2Report Type:Expedited (15-DaCompany Report #MX-BRISTOL-MYERS SQUIBB COMPANY-12941480 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Aspartate Pharmaceutical Other Aminotransferase Company, Ltd. ORAL Increased Biperiden C Asthenia Midazolam C Bacteria Urine Identified Blood Creatine Phosphokinase Increased Blood Urea Increased Body Temperature Increased Catatonia Confusional State Coordination Abnormal Dehydration Depressed Level Of Consciousness Gait Disturbance High Density Lipoprotein Increased Joint Sprain Muscle Rigidity Neutrophil Count Increased Stupor White Blood Cell Count Increased 22-Feb-2006 08:31 AM Page: 786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/05ISR Number: 4673312-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12972444 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/25/05ISR Number: 4677111-9Report Type:Direct Company Report #CTU 249571 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Abilify Bristol Hospitalization - Increased Myers Squibb, Co. PS Bristol Myers Initial or Prolonged Aspartate Squibb, Co. ORAL 15MG QD Required Aminotransferase ORAL Intervention to Increased Kaletra C Prevent Permanent Blood Glucose Decreased Viread C Impairment/Damage Blood Phosphorus Lexapro C Increased Abilify C Body Temperature Zithromax C Increased Lopressor C Confusional State Dilantin C Convulsion Coordination Abnormal Drug Interaction Dysarthria Dyspnoea Grand Mal Convulsion Hyperkalaemia Infection Liver Function Test Abnormal Mental Status Changes Neuroleptic Malignant Syndrome Renal Failure Acute Tachycardia Tremor Unresponsive To Verbal Stimuli Date:05/26/05ISR Number: 4674347-8Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12950507 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Abilify PS Otsuka Antidiuretic Hormone Pharmaceutical Secretion Company, Ltd. ORAL Seguril C Rexer C Distraneurine C Enalapril C 22-Feb-2006 08:31 AM Page: 787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4674693-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12973400 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Decreased Appetite Pharmaceutical Other Tardive Dyskinesia Company, Ltd. Urine Output Decreased Seroquel C Cogentin C Date:05/26/05ISR Number: 4674695-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12970422 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/26/05ISR Number: 4676951-XReport Type:Expedited (15-DaCompany Report #2005077315 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zoloft (Sertraline) PS Initial or Prolonged Treatment Noncompliance Professional Abilify Company (Aripiprazole) SS Representative Date:05/27/05ISR Number: 4675334-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12352936 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Somnolence Pharmaceutical Other Suicide Attempt Company, Ltd. ORAL 2 MON Ibuprofen C Quetiapine C Cimetidine C Date:05/27/05ISR Number: 4675335-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12527966 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. pt on ability "since the beginning of 2003". Topamax C Effexor C Trazodone Hcl C Apothecon Two tablets daily and three tablets nightly 22-Feb-2006 08:31 AM Page: 788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675337-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12754370 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify Tabs 5 Mg PS Otsuka Dyspnoea Pharmaceutical Food Craving Company, Ltd. ORAL 30 mg/day Hepatitis around 2002, Hunger then stopped. Restarted 31-Oct-2004, Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 30 mg/day around 2002, then stopped. Restarted 31-Oct-2004, Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 30 mg/day around 2002, then stopped. Restarted 31-Oct-2004, Tegretol C Lorazepam C Date:05/27/05ISR Number: 4675339-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12783858 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Abilify PS Otsuka Initial or Prolonged Mania Pharmaceutical Company, Ltd. ORAL Resumed at 5 mg/day 3 DAY Antidepressant C Date:05/27/05ISR Number: 4675341-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12819264 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Increased to 15 mg/day 1 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 15 mg/day 1 DAY Geodon SS Trileptal C Lexapro C Zyprexa C 22-Feb-2006 08:31 AM Page: 789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675343-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12824249 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polycythaemia Abilify PS Otsuka Psychotic Disorder Pharmaceutical Vomiting Company, Ltd. ORAL Initiated 10 mg/day on 17-Aug-04; inc to 15 mg/day on Seroquel C Risperdal C Benadryl C Date:05/27/05ISR Number: 4675345-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825915 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify PS Otsuka Initial or Prolonged Dizziness Pharmaceutical Other Fall Company, Ltd. ORAL Dose lowered, Lower Limb Fracture pt relapsed Schizophrenia Clozapine SS ORAL White Blood Cell Count Neurontin C Increased Eskalith C Date:05/27/05ISR Number: 4675347-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12840757 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL 1 MON Date:05/27/05ISR Number: 4675348-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12842944 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:05/27/05ISR Number: 4675349-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12843926 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Abilify Tabs 5 Mg PS Otsuka Swollen Tongue Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675350-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12846143 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Prozac C Date:05/27/05ISR Number: 4675351-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12846515 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675352-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12846804 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. ORAL Aminotransferase Naltrexone C Increased Lithium C Fatigue Lamictal C Leukocytosis Nausea Date:05/27/05ISR Number: 4675353-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12847323 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Abilify PS Otsuka Decreased Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675354-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12847802 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify PS Otsuka Rash Pharmaceutical Urticaria Company, Ltd. ORAL 2 DAY Date:05/27/05ISR Number: 4675355-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12848453 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. Dosage reduced then withdrawn. 22-Feb-2006 08:31 AM Page: 791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675356-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12848537 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675357-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12849204 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Insomnia Pharmaceutical Speech Disorder Company, Ltd. 8 DAY Date:05/27/05ISR Number: 4675358-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12849584 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Abilify PS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Lamictal C Trazodone Hcl C Apothecon Klonopin C Efexor C Synthroid C Topamax C Date:05/27/05ISR Number: 4675359-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12849618 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Menstruation Irregular Pharmaceutical Oedema Peripheral Company, Ltd. 6 MON Date:05/27/05ISR Number: 4675360-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12851481 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675361-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12852752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675362-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12853040 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Loss Of Consciousness Pharmaceutical Other Medication Error Company, Ltd. Tremor Date:05/27/05ISR Number: 4675363-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12853487 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675364-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12853776 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Mydriasis Pharmaceutical Photophobia Company, Ltd. Initiated at 10 mg/day, increased to 15 mg/day, decreased to Date:05/27/05ISR Number: 4675365-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12854709 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Abilify PS Otsuka Tremor Pharmaceutical Weight Decreased Company, Ltd. 9 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. 9 MON Vasotec C Zocor C Date:05/27/05ISR Number: 4675366-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12855037 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Abilify Tabs 5 Mg PS Otsuka Nausea Pharmaceutical Company, Ltd. 2 MON Depakote Er C Cogentin C Bactrim C 22-Feb-2006 08:31 AM Page: 793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675367-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12855920 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Deterioration Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675368-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12856019 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blunted Affect Abilify PS Otsuka Joint Stiffness Pharmaceutical Psychomotor Retardation Company, Ltd. 1 WK Date:05/27/05ISR Number: 4675369-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12856191 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Lexapro C Eskalith Cr C Date:05/27/05ISR Number: 4675370-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12856944 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 MON Protonix C Date:05/27/05ISR Number: 4675371-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12857272 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Drug Withdrawal Syndrome Pharmaceutical Pruritus Company, Ltd. 1 YR Restless Legs Syndrome Wellbutrin C Tongue Disorder Calcium C Tongue Dry Miralax C Tremor Date:05/27/05ISR Number: 4675372-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12857389 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675373-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12857397 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675374-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12857785 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Lamictal C Trileptal C Topamax C Klonopin C Detrol C Date:05/27/05ISR Number: 4675376-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12858189 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675377-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12858320 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Abilify PS Otsuka Non-Insulin-Dependent Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675378-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12859088 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Hypoglycaemia Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675379-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12859229 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675380-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12859310 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Abilify PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675381-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12859443 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bladder Spasm Abilify PS Otsuka Pollakiuria Pharmaceutical Pregnancy Company, Ltd. ORAL Restless Legs Syndrome Depo-Provera C Urinary Incontinence Tylenol C Date:05/27/05ISR Number: 4675382-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12859658 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Abilify Tabs 10 Mg PS Otsuka Muscular Weakness Pharmaceutical Sedation Company, Ltd. ORAL Reduced to 5 mg/day, then discontinued 2 MON Date:05/27/05ISR Number: 4675383-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12860300 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faeces Discoloured Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Methylphenidate C Ritalin C Melatonin C Date:05/27/05ISR Number: 4675384-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12860524 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Eskalith C Ambien C Lexapro C Trilafon C Imitrex C Vicodin C Klonopin C 22-Feb-2006 08:31 AM Page: 796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675385-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12861969 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Abilify PS Otsuka Initial or Prolonged Psychotic Disorder Pharmaceutical Company, Ltd. ORAL Paxil C 30 mg then reduced to 25 mg Date:05/27/05ISR Number: 4675386-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12862231 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Risperidal SS Concerta C Date:05/27/05ISR Number: 4675387-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12862421 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675388-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12862769 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify PS Otsuka Pharmaceutical Company, Ltd. Ambien C Date:05/27/05ISR Number: 4675389-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12862777 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated on 15-Mar-2004 (1/2 to 1 tablet of 20 mg), Date:05/27/05ISR Number: 4675390-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12863379 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675391-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12863403 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675392-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12864328 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs 5 Mg PS Otsuka Blood Glucose Increased Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Palpitations Wellbutrin C Neurontin C Xanax C Ativan C Maxalt C Date:05/27/05ISR Number: 4675393-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12864575 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Abilify PS Otsuka Tongue Oedema Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675394-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12864898 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Heart Rate Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675395-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12865291 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. Aminotransferase Increased Date:05/27/05ISR Number: 4675396-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12865606 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675397-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12866166 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675398-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12866331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Abilify PS Otsuka Lower Limb Fracture Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675399-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12866653 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Confusional State Company, Ltd. Musculoskeletal Stiffness Abilify SS Otsuka Pyrexia Pharmaceutical Company, Ltd. Depakote C Date:05/27/05ISR Number: 4675400-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12867164 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Abilify Tabs 5 Mg PS Otsuka Pain In Extremity Pharmaceutical Company, Ltd. ORAL Wellbutrin Sr C Trileptal C 450-600 Date:05/27/05ISR Number: 4675401-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12870697 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 5 Mg PS Otsuka Face Oedema Pharmaceutical Increased Appetite Company, Ltd. ORAL Consumer Muscle Tightness reduced dose Night Sweats to 2.5 mg/day Vision Blurred then 1.5 Weight Increased mg/day Lexapro C Ambien C Ativan C Topamax C 22-Feb-2006 08:31 AM Page: 799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675402-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12871588 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675403-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12871844 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Hyperhidrosis Pharmaceutical Prescribed Overdose Company, Ltd. ORAL Initiated at Vertigo 30 mg/day, inc to 45 mg/day, dec to 30 mg/day. 2 YR Geodon C Trazodone Hcl C Apothecon Initiated at 1 mg/day Date:05/27/05ISR Number: 4675404-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12872206 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Abilify PS Otsuka Initial or Prolonged Drooling Pharmaceutical Dystonia Company, Ltd. ORAL Muscle Spasms Seroquel SS ORAL Tremor Adderall Xr C Vomiting Date:05/27/05ISR Number: 4675405-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12873329 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify PS Otsuka Sinusitis Pharmaceutical Company, Ltd. 1 WK Concerta C Clonidine C Date:05/27/05ISR Number: 4675406-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12873451 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Abilify PS Otsuka Initial or Prolonged Rhabdomyolysis Pharmaceutical Company, Ltd. Wellbutrin C Celebrex C Efexor C Dyazide C Levoxyl C 22-Feb-2006 08:31 AM Page: 800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675407-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12875209 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Medication Error Pharmaceutical Urinary Retention Company, Ltd. Dose reduced to 10 mg/day 1 YR Buspar C Bristol-Myers Squibb Company 1 YR Valium C 1 YR Contraceptive C 1 YR Allegra C Synthroid C 1 YR Paxil I 1 YR Date:05/27/05ISR Number: 4675408-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12875324 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Swelling Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 6 DAY Wellbutrin C Date:05/27/05ISR Number: 4675409-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12876009 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Abilify PS Otsuka Medication Error Pharmaceutical Somnolence Company, Ltd. Stomach Discomfort Date:05/27/05ISR Number: 4675410-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12876652 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Painful Erection Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/27/05ISR Number: 4675411-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12879193 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypervigilance Abilify PS Otsuka Muscle Twitching Pharmaceutical Pollakiuria Company, Ltd. Suicidal Ideation Abilify SS Otsuka Vomiting Pharmaceutical Company, Ltd. Lexapro C Tylenol + Codeine C 22-Feb-2006 08:31 AM Page: 801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675412-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12879284 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/27/05ISR Number: 4675413-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12879862 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 15 Mg PS Otsuka Pain In Extremity Pharmaceutical Vision Blurred Company, Ltd. Lamictal C Date:05/27/05ISR Number: 4675414-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12879888 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675415-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12880043 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675416-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12880092 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675417-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12880167 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Darvon C Levoxyl C 22-Feb-2006 08:31 AM Page: 802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675418-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12880183 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify Tabs 5 Mg PS Otsuka Drooling Pharmaceutical Dysarthria Company, Ltd. Dyskinesia Concerta C Feeling Abnormal Clonidine C Incoherent Senokot C Mydriasis Miralax C Paranoia Seroquel C Pupillary Reflex Impaired Klonopin C Vision Blurred Date:05/27/05ISR Number: 4675419-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12880415 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675420-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12880498 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675421-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12881694 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 2.5 mg/day Date:05/27/05ISR Number: 4675422-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12881728 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anion Gap Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C Date:05/27/05ISR Number: 4675423-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12882411 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675424-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12882866 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hot Flush Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675425-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12883062 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675426-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12883138 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Insomnia Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675427-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12884599 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675428-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12884649 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel C Klonopin C Date:05/27/05ISR Number: 4675429-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12885554 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Aripiprazole PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Hypertension Company, Ltd. ORAL Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. ORAL Aspirin C Norvasc C Labetalol Hcl C Apothecon Ditropan C Effexor C 22-Feb-2006 08:31 AM Page: 804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tylenol C Colace C Date:05/27/05ISR Number: 4675430-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12885885 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Adderall Xr SS Date:05/27/05ISR Number: 4675431-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12885919 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Adderall Xr SS Date:05/27/05ISR Number: 4675432-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12886024 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675433-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12886602 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Deterioration Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675434-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12886883 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Dyspnoea Pharmaceutical Tachycardia Company, Ltd. ORAL Between 5-15 Urinary Incontinence mg/day Date:05/27/05ISR Number: 4675435-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12886933 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675436-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12887352 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Date:05/27/05ISR Number: 4675437-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12888566 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Initated 5 mg several months ago, increased to 10 mg for one Ativan C Paxil Cr C Date:05/27/05ISR Number: 4675438-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12888962 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675439-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12889192 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675440-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12890083 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. 6 MON Zoloft C Date:05/27/05ISR Number: 4675441-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12890364 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675442-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12890646 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675443-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12890869 Age:8 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675444-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12891040 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 5 Mg PS Otsuka Eye Pain Pharmaceutical Headache Company, Ltd. Nausea Trazodone Hcl C Apothecon Effexor C Klonopin C Date:05/27/05ISR Number: 4675445-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12891438 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Wound Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675446-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12891578 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1/2 of a 10 mg tablet 2 WK Depakote Er C Zyprexa C (WEANING)20 MG TO 10 MG Date:05/27/05ISR Number: 4675447-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12893194 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Abilify PS Otsuka Neutropenia Pharmaceutical Company, Ltd. Decreased to 5 mg/day 4 MON Concerta C Depakote C 22-Feb-2006 08:31 AM Page: 807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675448-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12893855 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Effexor C Prozac C Date:05/27/05ISR Number: 4675449-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12893863 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 WK Date:05/27/05ISR Number: 4675450-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12894606 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. Aminotransferase Zyprexa C Increased Date:05/27/05ISR Number: 4675451-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12895579 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Fluctuation Abilify PS Otsuka Initial or Prolonged Glycosylated Haemoglobin Pharmaceutical Increased Company, Ltd. ORAL 1 YR Date:05/27/05ISR Number: 4675452-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12895660 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical Obsessive-Compulsive Company, Ltd. 6 MON Disorder Buspar Tabs 30 Mg C Restlessness Trileptal C Somnolence Tardive Dyskinesia Thought Blocking Visual Acuity Reduced Vomiting 22-Feb-2006 08:31 AM Page: 808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675453-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12895678 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify Tabs 5 Mg PS Otsuka Drooling Pharmaceutical Moaning Company, Ltd. ORAL Psychomotor Retardation Abilify Tabs 5 Mg SS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Serzone C Bristol-Myers Squibb Company Clonidine C Date:05/27/05ISR Number: 4675454-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12895850 Age:6 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Ritalin C Date:05/27/05ISR Number: 4675455-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12895868 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. Zelnorm C Wellbutrin Xl C Atenolol C Sandoz Inc. (Geneva Pharm Tech) Topamax C Septra C Lexapro C Nexium C Synthroid C Trileptal C Dostinex C Lisinopril C Seroquel C Viramune C Truvada C Date:05/27/05ISR Number: 4675456-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12896247 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Extrapyramidal Disorder Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675457-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12896346 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. Prozac C Tegretol C Neurontin C Seroquel C Date:05/27/05ISR Number: 4675458-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12896403 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 10 Mg PS Otsuka Malaise Pharmaceutical Nausea Company, Ltd. ORAL 3 WK Wellbutrin Xl C Amaryl C Diazepam C Date:05/27/05ISR Number: 4675459-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12896833 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nuchal Rigidity Abilify PS Otsuka Priapism Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675460-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12897153 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify PS Otsuka Somnolence Pharmaceutical Weight Increased Company, Ltd. ORAL 1 YR Lexapro C Date:05/27/05ISR Number: 4675461-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12897278 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675462-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12897815 Age:2 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Aripiprazole PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Date:05/27/05ISR Number: 4675463-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12898565 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 YR Adderall C Date:05/27/05ISR Number: 4675464-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12898763 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Topamax C Duration of therapy: years Synthroid C Duration of therapy: years Date:05/27/05ISR Number: 4675465-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12899126 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Back Pain Pharmaceutical Grand Mal Convulsion Company, Ltd. Date:05/27/05ISR Number: 4675466-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12899522 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Strattera C 1 MON Omeprazole C Zocor C Lisinopril C Klonopin C Claritin C Nasarel C NASAL Etodolac C 22-Feb-2006 08:31 AM Page: 811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675467-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12899647 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675468-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12899688 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Abilify PS Otsuka Pharmaceutical Company, Ltd. Duration: Less than 3 weeks 3 WK Date:05/27/05ISR Number: 4675469-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12900031 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 WK Cogentin C Lithium C Date:05/27/05ISR Number: 4675470-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12900387 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675471-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12900924 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 5 Mg PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL Nitroquick C Lidocaine C Valium C Trazodone Hcl C Apothecon Celexa C Prilosec C Mucinex C Date:05/27/05ISR Number: 4675472-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12900981 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 10 Mg PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Effexor C Neurontin C Date:05/27/05ISR Number: 4675474-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12901161 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Abilify PS Otsuka Suicidal Ideation Pharmaceutical Company, Ltd. 1 YR Abilify SS Otsuka Pharmaceutical Company, Ltd. 1 YR Provigil C Cogentin C Luvox C Date:05/27/05ISR Number: 4675475-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12901252 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Constipation Pharmaceutical Restlessness Company, Ltd. 4 WK Date:05/27/05ISR Number: 4675476-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12901344 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/27/05ISR Number: 4675477-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12901534 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675478-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12901922 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Abilify PS Otsuka Blood Prolactin Increased Pharmaceutical Convulsion Company, Ltd. ORAL Prescribed Overdose Moban SS 150 mg/day Vision Blurred from 1997 to Weight Increased Sep-2003; decreased to 100 mg/day in 22-Feb-2006 08:31 AM Page: 813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topamax C 150-200 mg twice daily Topamax C 150-200 mg twice daily Neurontin C Zarontin C ORAL 2-3 caps twice daily Benzatropine C ORAL Minocycline C ORAL Eskalith Cr C ORAL Date:05/27/05ISR Number: 4675479-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12902102 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Confusional State Pharmaceutical Fall Company, Ltd. 15 mg about 6 Hallucination months ago; Pollakiuria then 10 mg Pyrexia daily 6 MON Thirst Abilify SS Otsuka Vomiting Pharmaceutical Company, Ltd. 15 mg about 6 months ago; then 10 mg daily 6 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. 15 mg about 6 months ago; then 10 mg daily 6 MON Lithium C Depakote C Date:05/27/05ISR Number: 4675480-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12902516 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Luvox C Seroquel C Date:05/27/05ISR Number: 4675481-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12903506 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 20 Mg PS Otsuka Tunnel Vision Pharmaceutical Vision Blurred Company, Ltd. ORAL 1 YR Vomiting Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 YR Trazodone Hcl Tabs C Apothecon Xanax C 22-Feb-2006 08:31 AM Page: 814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro C Date:05/27/05ISR Number: 4675482-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12903803 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675483-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12905212 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675484-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12905683 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Movement Disorder Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 4 MON Cogentin C Remeron C Date:05/27/05ISR Number: 4675485-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12905741 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675486-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12907325 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Muscle Spasms Pharmaceutical Company, Ltd. Lexapro C 10 mg to 20 mg Date:05/27/05ISR Number: 4675487-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12907861 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. Initiated at 20 mg/day 2 YR Topamax C 22-Feb-2006 08:31 AM Page: 815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Date:05/27/05ISR Number: 4675488-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12907895 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 5 mg/day, inc to 10 mg/day two months later, then Effexor C Temazepam C Date:05/27/05ISR Number: 4675489-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12908323 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675490-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12908331 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675491-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12908760 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 15 mg/day then reduced to 10 mg/day 2 YR Date:05/27/05ISR Number: 4675492-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12909065 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Posture Abnormal Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 5 mg/day, increased to 10 mg/day 22-Feb-2006 08:31 AM Page: 816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675493-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12909164 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Wellbutrin C Aspirin C Vitamin B Complex C Alpha-Lipoic Acid C L-Carnitine C Selenium C Borage Oil C Vitamin E C Date:05/27/05ISR Number: 4675494-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12909453 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675495-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910154 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menstruation Irregular Abilify PS Otsuka Pharmaceutical Company, Ltd. Minocycline C Ranitidine C Date:05/27/05ISR Number: 4675496-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910618 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Abilify PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. 4 MON Date:05/27/05ISR Number: 4675497-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910659 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675498-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910675 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675499-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910683 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Titrated to 10 mg/day, and eventually up to 25 mg/day Date:05/27/05ISR Number: 4675500-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910774 Age:7 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Abilify PS Otsuka Abnormal Pharmaceutical Company, Ltd. Lamotrigine C Date:05/27/05ISR Number: 4675501-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910790 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify PS Otsuka Syndrome Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675502-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12911640 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 MON Morphine C Insulin C Date:05/27/05ISR Number: 4675503-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12911806 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Impatience Abilify PS Otsuka Increased Appetite Pharmaceutical Weight Increased Company, Ltd. 2 MON Date:05/27/05ISR Number: 4675504-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12911871 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. Lexapro C 22-Feb-2006 08:31 AM Page: 818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675506-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12912051 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Abilify PS Otsuka Pharmaceutical Company, Ltd. Ativan C Thiamine C Transdermal Nicotine C TRANSDERMAL Date:05/27/05ISR Number: 4675507-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12912200 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Strattera C ORAL Concerta C ORAL Date:05/27/05ISR Number: 4675508-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12912481 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 5 Mg PS Otsuka Feeling Abnormal Pharmaceutical Hallucination Company, Ltd. 2 WK Incoherent Zoloft C Thirst Lamictal C 6 MON Urine Output Increased Date:05/27/05ISR Number: 4675509-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12912770 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. 2 MON Glucophage C Bristol-Myers Squibb Company Seroquel C Date:05/27/05ISR Number: 4675510-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12913828 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Abilify Tabs 30 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. Trazodone Hcl C Apothecon Verapamil C Potassium C Lasix C Cogentin C Seroquel C Kristalose C Oxygen C NASAL 22-Feb-2006 08:31 AM Page: 819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675511-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12914743 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 10 Mg PS Otsuka Paranoia Pharmaceutical Phagophobia Company, Ltd. Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. Risperdal C Aspirin C Multivitamins C Date:05/27/05ISR Number: 4675512-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12916151 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Dose dec to 20 mg/day Date:05/27/05ISR Number: 4675513-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12916573 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675514-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12916888 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Head Banging Pharmaceutical Intentional Self-Injury Company, Ltd. Increased to 20 mg/day Paxil C Tegretol C Date:05/27/05ISR Number: 4675515-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12917068 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675516-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12917662 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. 1 YR Neurontin C Trileptal C Date:05/27/05ISR Number: 4675517-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12918231 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675518-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12918900 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify Tabs 10 Mg PS Otsuka Rash Maculo-Papular Pharmaceutical Swollen Tongue Company, Ltd. ORAL Haldol C Cogentin C Date:05/27/05ISR Number: 4675519-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12918918 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675520-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12919379 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675521-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12919825 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675522-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12920245 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Walking Abilify PS Otsuka Urinary Incontinence Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675523-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12920658 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Abilify PS Otsuka Dystonia Pharmaceutical Company, Ltd. 1 DAY Date:05/27/05ISR Number: 4675524-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12920856 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675525-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12921151 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675526-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12921797 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Prescribed Overdose Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Wellbutrin C Provigil C Date:05/27/05ISR Number: 4675527-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12922050 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Nausea Pharmaceutical Palpitations Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675528-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12922191 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675529-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12922308 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperacusis Abilify PS Otsuka Nausea Pharmaceutical Visual Disturbance Company, Ltd. 1 WK Lithium Carbonate C Coumadin C Bristol-Myers Squibb Company Lamictal C Date:05/27/05ISR Number: 4675530-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12923017 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Hepatic Enzyme Increased Pharmaceutical Mental Status Changes Company, Ltd. Date:05/27/05ISR Number: 4675531-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12923603 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pregnancy Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675532-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12923629 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Adderall C Date:05/27/05ISR Number: 4675533-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12923900 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Thirst Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675534-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12924007 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. 4 WK Depakote C 5 YR Date:05/27/05ISR Number: 4675535-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12924064 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Pharmaceutical Company, Ltd. Initiated at 5 mg/day, inc to 20 mg/day, dec to 15 mg/day Date:05/27/05ISR Number: 4675536-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12924098 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675537-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12924981 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675538-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12925145 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote Er C Augmentin C Date:05/27/05ISR Number: 4675539-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12925202 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Strattera SS 22-Feb-2006 08:31 AM Page: 824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675540-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12925335 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675541-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12925343 Age:8 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675542-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926150 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675544-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Lamictal C Date:05/27/05ISR Number: 4675545-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926408 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petit Mal Epilepsy Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 10 mg/day on 07-Apr-2005. Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 10 mg/day on 07-Apr-2005. Klonopin C Depakote C Date:05/27/05ISR Number: 4675546-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926507 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675547-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926697 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675548-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12926762 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675549-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12927208 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Psychomotor Hyperactivity Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675550-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12927463 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Abilify PS Otsuka Pharmaceutical Company, Ltd. Allegra C Levothyroid C Date:05/27/05ISR Number: 4675551-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12928396 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Hunger Pharmaceutical Pollakiuria Company, Ltd. 30 mg/day at Weight Increased time of report Tegretol C Ambien C Vytorin 10/20 C 10/40 Ibroprofen C Mobic C Date:05/27/05ISR Number: 4675552-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12928719 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. 5 mg 3 weeks ago, then 22-Feb-2006 08:31 AM Page: 826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report incr to 10 mg 2 weeks ago which Date:05/27/05ISR Number: 4675553-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12928875 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675554-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12929147 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Abilify PS Otsuka Insomnia Pharmaceutical Oedema Peripheral Company, Ltd. Consumer Weight Increased decreased aripiprazole to 2.5 mg/day Abilify SS Otsuka Pharmaceutical Company, Ltd. Consumer decreased aripiprazole to 2.5 mg/day Celxa C Ativan C Lasix C Potassium C Prevacid C Date:05/27/05ISR Number: 4675555-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12929196 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675556-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12929931 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Abilify PS Otsuka Increased Pharmaceutical Aspartate Company, Ltd. 2 WK Aminotransferase Paxil Cr C Increased Aciphex C Zyrtec C Gabitril C 22-Feb-2006 08:31 AM Page: 827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675557-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12930061 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Burning Sensation Abilify PS Otsuka Muscle Tightness Pharmaceutical Company, Ltd. 1 MON Date:05/27/05ISR Number: 4675558-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12930517 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Abilify PS Otsuka Feeling Abnormal Pharmaceutical Headache Company, Ltd. Lexapro C Doxycycline C Valtrex C Clonazepam C Triamcinolone C Apothecon TOPICAL Ketoconazole C Flonase C Spiriva C Multivitamins C Glucosamine C Refresh C Date:05/27/05ISR Number: 4675559-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12930632 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Abilify Tabs 10 Mg PS Otsuka Back Pain Pharmaceutical Confusional State Company, Ltd. Faecal Incontinence Abilify Tabs 10 Mg SS Otsuka Oedema Peripheral Pharmaceutical Pain In Extremity Company, Ltd. Parkinsonism Pravachol C Bristol-Myers Squibb Urinary Incontinence Company Weight Increased Altace C Glyburide C Sandoz Inc. (Geneva Pharm Tech) Oxytrol C TRANSDERMAL Ibuprofen C Date:05/27/05ISR Number: 4675560-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12930822 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675561-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12930848 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Performance Status Abilify PS Otsuka Decreased Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675562-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12931440 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675563-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12931929 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675564-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12932042 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. Depakote C Date:05/27/05ISR Number: 4675565-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12932125 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675566-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12932406 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. 3 DAY Date:05/27/05ISR Number: 4675567-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12933123 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pyrexia Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exelon C Date:05/27/05ISR Number: 4675568-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12933602 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675569-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12933842 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dissociation Abilify PS Otsuka Thinking Abnormal Pharmaceutical Company, Ltd. Seroquel C Date:05/27/05ISR Number: 4675570-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12933859 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Abilify PS Otsuka Pharmaceutical Company, Ltd. Insulin C Zocor C 20 mg qHS Multivitamin C Docusate C Norvasc C Enalapril C Vitamin E C Coreg C Zoloft C 150 mg qHS Fibercon C q AM Senna C q AM Date:05/27/05ISR Number: 4675571-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12934048 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 MON Date:05/27/05ISR Number: 4675572-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12935532 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675573-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12936480 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Visual Disturbance Pharmaceutical Company, Ltd. Increased to 10 mg/day Adderall C Prozac C Date:05/27/05ISR Number: 4675574-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12936720 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Social Abilify PS Otsuka Behaviour Pharmaceutical Mental Disorder Company, Ltd. Doses of 5 or Schizophrenia 10 mg/day Speech Disorder Date:05/27/05ISR Number: 4675575-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12936860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Increased to 30 mg/day 5 WK Date:05/27/05ISR Number: 4675576-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12936910 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Abilify Tabs 5 Mg PS Otsuka Pain In Extremity Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675577-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12937157 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Abilify PS Otsuka Pharmaceutical Company, Ltd. Prozac C Lamictal C Date:05/27/05ISR Number: 4675578-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938320 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Abilify PS Otsuka Initial or Prolonged Corrected Interval Pharmaceutical Other Prolonged Company, Ltd. 2 YR Hypertension Celxa C Digoxin C 22-Feb-2006 08:31 AM Page: 831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Labetalol C Norvasc C Date:05/27/05ISR Number: 4675579-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938569 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675580-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Psychotic Disorder Pharmaceutical Company, Ltd. Seroquel C Date:05/27/05ISR Number: 4675581-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938767 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Pharmaceutical Company, Ltd. 10 mg then 15 mg Date:05/27/05ISR Number: 4675582-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938775 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675583-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938973 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675584-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939419 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affect Lability Abilify Tabs 5 Mg PS Otsuka Anorexia Pharmaceutical Lethargy Company, Ltd. ORAL Initiated at Somnolence 2.5 mg/day Tremor Adderall C Seroquel C 22-Feb-2006 08:31 AM Page: 832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675585-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939807 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. 1 YR Date:05/27/05ISR Number: 4675586-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. 10 DAY Risperdal C Quetiapine C Date:05/27/05ISR Number: 4675587-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12940516 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675588-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12940748 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 YR Date:05/27/05ISR Number: 4675589-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12941274 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. 2 YR Date:05/27/05ISR Number: 4675590-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12941548 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675591-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12941829 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:05/27/05ISR Number: 4675592-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12941845 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gynaecomastia Abilify PS Otsuka Pharmaceutical Company, Ltd. Prozac C Date:05/27/05ISR Number: 4675593-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12941894 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675594-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12942165 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Eye Movement Disorder Pharmaceutical Tremor Company, Ltd. Increased to 10 mg twice daily Wellbutrin Xl C 1 MON Strattera C Date:05/27/05ISR Number: 4675595-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12942199 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Abilify PS Otsuka Anorexia Pharmaceutical Chromaturia Company, Ltd. Insomnia Demerol C Nausea Lidocaine C Thinking Abnormal Date:05/27/05ISR Number: 4675596-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12942769 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Multivitamin C Nutritional Supplement C 22-Feb-2006 08:31 AM Page: 834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675597-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12943270 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Effexor C Date:05/27/05ISR Number: 4675598-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12943577 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erythema Abilify PS Otsuka Hyperhidrosis Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675599-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12943601 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Abnormal Abilify Tabs 5 Mg PS Otsuka Dizziness Postural Pharmaceutical Heart Rate Increased Company, Ltd. 5 mg on 01-Apr-05; on 21-Apr-05 reduced to 5 mg - 1/2 Strattera C Trileptal C Date:05/27/05ISR Number: 4675600-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12943627 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Abilify PS Otsuka Decreased Pharmaceutical Company, Ltd. 2.5 mg Nov-03; increased to 3.5 mg and 5 mg on Date:05/27/05ISR Number: 4675601-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12944179 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Acne Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Strattera C Risperdal C Prozac C 22-Feb-2006 08:31 AM Page: 835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675602-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12945069 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affect Lability Abilify PS Otsuka Crying Pharmaceutical Dyskinesia Company, Ltd. Hyperacusis Trileptal C Photophobia Strattera C Social Avoidant Behaviour Date:05/27/05ISR Number: 4675603-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12946026 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675604-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12946067 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675605-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12946133 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675606-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12946943 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Abilify PS Otsuka Musculoskeletal Stiffness Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675607-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12947347 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flat Affect Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675608-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12948113 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initiated at 5 mg/day, increased to 10 mg/day Lexapro C Date:05/27/05ISR Number: 4675609-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12948394 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify PS Otsuka Pharmaceutical Company, Ltd. 3 MON Date:05/27/05ISR Number: 4675610-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12948600 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675611-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12949376 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify PS Otsuka Dysphagia Pharmaceutical Tremor Company, Ltd. ORAL Date:05/27/05ISR Number: 4675612-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12949624 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Nausea Pharmaceutical Pregnancy Company, Ltd. Tremor Abilify SS Otsuka Vomiting Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Lexapro C Date:05/27/05ISR Number: 4675613-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12951281 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Insomnia Pharmaceutical 22-Feb-2006 08:31 AM Page: 837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. 5 WK Labetalol C Humalog C 75/25, 30 units in the AM and 15 units in the PM Avandia C Aciphex C Aspirin C Clarinex C Date:05/27/05ISR Number: 4675614-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12951612 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675615-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12951661 Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:05/27/05ISR Number: 4675617-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12954202 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 10 Mg PS Otsuka Delusion Pharmaceutical Insomnia Company, Ltd. ORAL 16 DAY Restlessness Ambien C Tylenol Pm C Date:05/31/05ISR Number: 4677328-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12784559 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breech Presentation Abilify PS Otsuka Caesarean Section Pharmaceutical Death Neonatal Company, Ltd. TRANSPLACENTAL 31 WK Drug Exposure During Pregnancy Premature Baby Twin Pregnancy Date:05/31/05ISR Number: 4677329-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12931341 Age:60 YR Gender:Male I/FU:F Outcome PT Death Blood Ph Decreased Other Diabetic Hyperosmolar Coma 22-Feb-2006 08:31 AM Page: 838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Nausea Prescribed Overdose Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:05/31/05ISR Number: 4677484-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12949863 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myeloid Leukaemia Abilify PS Otsuka Initial or Prolonged Chest Discomfort Pharmaceutical Other Nausea Company, Ltd. Lipitor C 6 MON Cozaar C 6 MON Zoloft C 2 YR Buspar C Bristol-Myers Squibb Company Date:05/31/05ISR Number: 4677681-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12975983 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Abilify PS Otsuka Life-Threatening Convulsion Pharmaceutical Dyspnoea Company, Ltd. ORAL Pulmonary Embolism Abilify SS Otsuka Shock Pharmaceutical Thrombosis Company, Ltd. ORAL Fluoxetine C Date:05/31/05ISR Number: 4678842-7Report Type:Expedited (15-DaCompany Report #S05-USA-02675-01 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Lexapro Initial or Prolonged Death Of Friend (Esctialopram) PS ORAL 10 MG QD PO Depression Lexapro Drug Ineffective (Esctialopram) SS ORAL 20 MG QD PO Hallucination Lexapro Overdose (Esctialopram) SS ORAL 30 MG QD PO Post-Traumatic Stress Lexapro Disorder (Esctialopram) SS ORAL 40 MG QD PO Suicidal Ideation Lexapro Suicide Attempt (Esctialopram) SS ORAL 50 MG QD PO Therapeutic Product Lexapro Ineffective For (Esctialopram) SS ORAL 30 MG QD PO Unapproved Indication Lexapro (Esctialopram) SS ORAL 50 MG QD PO Elavil (Amitriptyline Hydrochloride) SS 50 MG QD Klonopin (Clonazepam) SS 1 MG QD Ritalin (Methylphenidate Hydrochloride) SS 30 MG QD 22-Feb-2006 08:31 AM Page: 839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ability (Aripiprazole) SS Geodon (Ziprasidone Hydrochloride) SS ORAL 40 MG QD PO Date:06/01/05ISR Number: 4678265-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12976791 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Other Depressed Mood Pharmaceutical Company, Ltd. ORAL Zyprexa C Temesta C Date:06/01/05ISR Number: 4678266-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12901054 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Haloperidol C ORAL Phenergan C ORAL Lorazepam C ORAL Procyclidine C ORAL Date:06/02/05ISR Number: 4679336-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12977286 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify PS Otsuka Initial or Prolonged Heart Rate Increased Pharmaceutical Lower Limb Fracture Company, Ltd. Date:06/02/05ISR Number: 4679403-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12977161 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Blinded: Initial or Prolonged Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/02/05ISR Number: 4681629-2Report Type:Expedited (15-DaCompany Report #CAR_0020_2005 Age:43 YR Gender:Male I/FU:I Outcome PT Akathisia Alanine Aminotransferase Increased Depression Masked Facies Musculoskeletal Stiffness Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychomotor Retardation Psychotic Disorder Restlessness Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Fluoxetine PS 20 MG QDAY Tachycardia Aripiprazole SS 30 MG QDAY 2 WK Tremor Date:06/03/05ISR Number: 4681169-0Report Type:Expedited (15-DaCompany Report #HU-BRISTOL-MYERS SQUIBB COMPANY-12938809 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL Clonazepam C Procyclidine C Date:06/03/05ISR Number: 4681170-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12980124 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Agitation Pharmaceutical Balance Disorder Company, Ltd. ORAL Head Titubation Diazepam C UNKNOWN 1-2 three Pain In Extremity times daily. Salivary Hypersecretion Vision Blurred Date:06/06/05ISR Number: 4682211-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12983797 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Abilify PS Otsuka Oculogyration Pharmaceutical Company, Ltd. ORAL 5 MON Dianette C Date:06/06/05ISR Number: 4682606-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12945069 Age:11 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Affect Lability Abilify PS Otsuka Crying Pharmaceutical Dyskinesia Company, Ltd. ORAL Hyperacusis Abilify SS Otsuka Photophobia Pharmaceutical Social Avoidant Behaviour Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Trileptal C 1 YR Strattera C 22-Feb-2006 08:31 AM Page: 841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/05ISR Number: 4683956-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12806022 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Abilify PS Otsuka Retinal Disorder Pharmaceutical Company, Ltd. ORAL 15 mg then reduced to 10 mg/day 6 WK Paracetamol C Flomax C Date:06/08/05ISR Number: 4686638-5Report Type:Expedited (15-DaCompany Report #2005-05-2285 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Trilafon Initial or Prolonged Drug Interaction Health (Perphenazine)Tablet Headache Professional s PS ORAL 32 MG QD ORAL Nausea Other Trilafon Vomiting (Perphenazine)Tablet s SS ORAL 24 MG QD ORAL Abilify (Aripiprazole) Tablets SS ORAL 15 MG QD ORAL Abilify (Aripiprazole) Tablets SS ORAL 10 MG QD ORAL Imovane Tablets C Rivotril Tablets C Date:06/09/05ISR Number: 4686597-5Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12986485 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Abilify PS Otsuka Initial or Prolonged Drug Interaction Pharmaceutical Physical Assault Company, Ltd. Zyprexa C Dose decreased to 10 mg daily on 09-Oct-2004/d Absenor C Initiated on an unknown date at 1.5 grams twice daily/Decreas Keppra C Stesolid C Imovane C Date:06/09/05ISR Number: 4686616-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12959342 Age:5 DEC Gender:Female I/FU:F Outcome PT Other Cerebrovascular Accident Condition Aggravated Confusional State 22-Feb-2006 08:31 AM Page: 842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Retardation Severity Unspecified Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 MON Date:06/09/05ISR Number: 4688635-2Report Type:Direct Company Report #CTU 250860 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypoglycaemia Abilify PS Ostukazeneca Hospitalization - Weight Decreased Subsidiary To Initial or Prolonged Brystol Myers Squibb 20 MGS 1 Other DAILY MOOD STABILIZER AM Date:06/09/05ISR Number: 4688745-XReport Type:Direct Company Report #CTU 250864 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Abilify 2.5-10 Mg PS ORAL PO QD Adderall C Date:06/10/05ISR Number: 4687575-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12990008 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Xanax C Tercian C Date:06/10/05ISR Number: 4687584-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12989166 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/10/05ISR Number: 4687597-1Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12994786 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oropharyngeal Spasm Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/05ISR Number: 4687598-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12994968 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oropharyngeal Spasm Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/10/05ISR Number: 4687600-9Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12994760 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oropharyngeal Spasm Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:06/10/05ISR Number: 4687603-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12990412 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Hypertension Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/10/05ISR Number: 4687629-0Report Type:Expedited (15-DaCompany Report #PHEH2005US06346 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Ritalin PS Novartis Sector: Hospitalization - Drug Ineffective Pharma ORAL 30 mg, QD Initial or Prolonged Hallucination Lexapro SS ORAL 10 mg, QD 10080MIN Other Post-Traumatic Stress Lexapro SS ORAL 20 mg, QD 10080MIN Disorder Lexapro SS ORAL 30 mg, QD 10080MIN Suicidal Ideation Lexapro SS ORAL 40 mg, QD 10080MIN Suicide Attempt Lexapro SS ORAL 50 mg, QD Lexapro SS ORAL 30 mg, QD Lexapro SS ORAL 50 mg, QD Elavil SS ORAL 50 mg, QD Klonopin SS ORAL 1 mg, QD Abilify SS ORAL UNK, UNK 104 DAY Geodon SS ORAL 40 mg, QD Date:06/10/05ISR Number: 4687848-3Report Type:Direct Company Report #CTU 250885 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complication Of Pregnancy Prozac 20 Mg PS ORAL ONE DAILY Drug Exposure During ORAL Pregnancy Abilify 10 Mg SS ORAL ONE DAILY Drug Withdrawal Syndrome ORAL Neonatal Dyskinesia Neonatal Eye Movement Disorder Irritability Movement Disorder Neonatal Disorder 22-Feb-2006 08:31 AM Page: 844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/05ISR Number: 4688623-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12989844 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Aripiprazole PS Otsuka Initial or Prolonged Hypovolaemia Pharmaceutical Company, Ltd. 4 DAY Metformin Hcl C Bristol-Myers Squibb Company Diazepam C 2.5 mg twice a day and 5 mg at bedtime. Olanzapine C At bedtime Rosiglitazone C Date:06/13/05ISR Number: 4689026-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12994562 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/13/05ISR Number: 4689077-6Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12939450 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Disability Syndrome Company, Ltd. ORAL Initiated at Other Prescribed Overdose 10 to 20 mg/day; inc to 20-40 mg/day on Luvox C ORAL Chlorpromazine C Chlorpromazine C Date:06/13/05ISR Number: 4689187-3Report Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-12991469 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Disability Urinary Tract Infection Company, Ltd. ORAL 1 WK Other Levomepromazine C 100 mg x 1 titrated down to 50 mg x 1. Rivatril C 0.5 mg x 2 titrated down to 0.5 mg x 1 and later discontinued Diazepam C 10 mg 1 x 1 for the night. 22-Feb-2006 08:31 AM Page: 845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/05ISR Number: 4689188-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12992129 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Hypertension Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 YR Date:06/13/05ISR Number: 4691450-7Report Type:Periodic Company Report #S05-USA-02568-01 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Health Lexapro Initial or Prolonged Drug Interaction Professional (Escitalopram) PS Intentional Misuse Lexapro Irritability (Escitalopram) SS ORAL 2.5 MG QD PO Lethargy Lexapro Suicidal Ideation (Escitalopram) SS ORAL 5 MG QD PO Lexapro (Escitalopram) SS ORAL 30 MG QD PO Lexapro (Escitalopram) SS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 5 MG QD PO Lexapro (Escitalopram) SS ORAL 2.5 MG QD PO Cytomel (Liothyronine Sodium) SS Cytomel (Liothyronine Sodium) SS Abilify (Aripiprazole) SS 10 MG QD Abilify (Aripiprazole) SS Klonopin (Clonazepam) SS Strattera (Atomoxetine) C Date:06/14/05ISR Number: 4689779-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12906269 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cardiac Failure Abilify PS Otsuka Other Congestive Pharmaceutical Insomnia Company, Ltd. ORAL Dose ranged Paranoia from 15 to 30 mg/day Temazepam C ORAL Vitamin B Complex C ORAL Thiamine Hcl C ORAL 100 TO 300 MG/DAY Vioxx C Rec'd on 25-Mar-04, 12-May-04, 13-Jul-04 and 19-Aug-04. Fluoxetine C ORAL 40-60 mg/day 22-Feb-2006 08:31 AM Page: 846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prochlorperazine Maleate C Flupentixol C Senna C Lactulose C ORAL 3.35g/5ml: 15 ml twice daily Locorten C Zopiclone C ORAL Date:06/14/05ISR Number: 4689784-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12983797 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Abilify PS Otsuka Loss Of Consciousness Pharmaceutical Oculogyration Company, Ltd. ORAL Dianette C ORAL Date:06/14/05ISR Number: 4689786-9Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-12991436 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Abilify PS Otsuka Hospitalization - Death Pharmaceutical Initial or Prolonged Company, Ltd. 2 MON Acetazolamide C Latanoprost + Timolol Maleate C OPHTHALMIC Date:06/15/05ISR Number: 4690459-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993390 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Abilify PS Otsuka Hospitalization - Appendicitis Pharmaceutical Initial or Prolonged Bradycardia Company, Ltd. 2 YR Other Carbon Dioxide Decreased Death Hypoxia Nausea Peritonitis Respiratory Distress Tachycardia Date:06/16/05ISR Number: 4691712-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12998977 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Excitability Pharmaceutical Company, Ltd. ORAL Zyprexa C Tercian C 22-Feb-2006 08:31 AM Page: 847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/05ISR Number: 4691731-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12995973 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Abilify PS Otsuka Coronary Artery Occlusion Pharmaceutical Company, Ltd. Increased to 15 mg/day, then discontinued Nexium C Date:06/16/05ISR Number: 4691735-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12995858 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Abilify PS Otsuka Oculogyration Pharmaceutical Company, Ltd. ORAL Dianette C ORAL Date:06/16/05ISR Number: 4691736-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12942199 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Dreams Abilify PS Otsuka Anorexia Pharmaceutical Chromaturia Company, Ltd. ORAL 6 DAY Insomnia Demerol C Nausea Lidocaine C Thinking Abnormal Lithium Citrate C Date:06/16/05ISR Number: 4694010-7Report Type:Expedited (15-DaCompany Report #PAR_0069_2005 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Fluoxetine PS 20 MG QDAY 2 WK Initial or Prolonged Alanine Aminotransferase Health Aripiprazole SS 30 MG QDAY Increased Professional Benzatropine C Blood Creatine Acetaminophen C Phosphokinase Increased Cogwheel Rigidity Depression Drug Interaction Drug Level Increased Labile Blood Pressure Masked Facies Musculoskeletal Stiffness Psychomotor Retardation Psychotic Disorder Pyrexia Restlessness Salivary Hypersecretion Tachycardia Tremor 22-Feb-2006 08:31 AM Page: 848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/05ISR Number: 4694174-5Report Type:Direct Company Report #CTU 251301 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril 730 Mg PS BID Depression Abilify 10 Mg SS DAILY Drowning Date:06/17/05ISR Number: 4693009-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006044 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 5 Mg PS Otsuka Life-Threatening Death Pharmaceutical Hospitalization - Loss Of Consciousness Company, Ltd. ORAL Initial or Prolonged Nausea Clozaril C Somnolence Vomiting Date:06/17/05ISR Number: 4693010-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12898516 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Abilify PS Otsuka Crohn'S Disease Pharmaceutical Vasculitis Company, Ltd. Initiated at 2.5 mg/day 10 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. Initiated at 2.5 mg/day 10 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. Initiated at 2.5 mg/day 10 MON Strattera C 10 MON Celexa C 10 MON Date:06/17/05ISR Number: 4694940-6Report Type:Expedited (15-DaCompany Report #DSA_26556_2005 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Foreign Temesta PS ORAL 1.25 MG Q DAY Dyskinesia Health PO Hypokinesia Professional Temesta SS ORAL 6.25 MG Q DAY Muscle Spasms Other PO Tongue Disorder Temesta SS ORAL 5 MG Q DAY PO Abilify SS ORAL 15 MG Q DAY PO Temesta C ORAL 6.25 MG QD DAY PO Date:06/20/05ISR Number: 4694360-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12998167 Age:17 YR Gender:Female I/FU:I Outcome PT Hospitalization - Depression Initial or Prolonged Drug Ineffective 22-Feb-2006 08:31 AM Page: 849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Intentional Misuse Post-Traumatic Stress Report Source Product Role Manufacturer Route Dose Duration Disorder Abilify PS Otsuka Suicidal Ideation Pharmaceutical Suicide Attempt Company, Ltd. Lexapro SS ORAL Elavil SS ORAL Klonopin SS Ritalin SS Geodon SS ORAL Date:06/20/05ISR Number: 4694593-7Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13000245 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Dyskinesia Pharmaceutical Hallucination Company, Ltd. ORAL Dosage Lung Disorder increased to Polydipsia Psychogenic 15 mg on 06-Apr-05 then Sulfarlem C Lepticur C Imovane C Prozac C Tercian C Rivotril C Risperidal C Date:06/20/05ISR Number: 4696109-8Report Type:Expedited (15-DaCompany Report #DSA_26579_2005 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Temesta PS ORAL 5 MG Q DAY PO Initial or Prolonged Increased Health Temesta SS ORAL 8.75 MG Q DAY Other Aspartate Professional PO Aminotransferase Other Temesta SS ORAL 1.25 MG Q DAY Increased PO Blood Alkaline Temesta SS ORAL 3.75 MG Q DAY Phosphatase Increased PO Blood Potassium Decreased Abilify SS ORAL 30 MG Q DAY Extrapyramidal Disorder PO Muscle Spasms Abilify SS ORAL 15 MG Q DAY Nasopharyngeal Disorder PO Tongue Disorder Trittico C Date:06/20/05ISR Number: 4696354-1Report Type:Expedited (15-DaCompany Report #KII-2005-0017032 Age:55 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Blood Creatine Phosphokinase Mb Increased Blood Glucose Decreased 22-Feb-2006 08:31 AM Page: 850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Electrocardiogram Qt Corrected Interval Report Source Product Role Manufacturer Route Dose Duration Prolonged Study Morphine Sulfate Health (Similar To Nda Professional 19-516) (Morphine Other Sulfate) Other PS ORAL ORAL Antipsychotics SS ORAL ORAL Abilify SS ORAL ORAL Hydrocodone W/Acetaminophen(Para cetamol, Hydrocodone Bitartrate) SS ORAL ORAL Date:06/20/05ISR Number: 4697323-8Report Type:Expedited (15-DaCompany Report #2005-05-2285 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Trilafon Initial or Prolonged Drug Interaction Health (Perphenazine) Emotional Disorder Professional Tablets PS ORAL SEE IMAGE Headache Other Abilify Nausea (Aripiprazole) Vomiting Tablets SS ORAL SEE IMAGE Imovane Tablets C Rivotril Tablets C Date:06/21/05ISR Number: 4695750-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12945184 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Abilify PS Otsuka Increased Pharmaceutical Haemoglobin Increased Company, Ltd. ORAL Initiated at Red Blood Cell Count 10 mg/day in Increased Nov-2004, Sinus Tachycardia increased to Ventricular Extrasystoles 15 mg/day on Sertraline C ORAL Lorazepam C Paracetamol C Clotrimazole C TOPICAL Date:06/21/05ISR Number: 4695757-9Report Type:Expedited (15-DaCompany Report #AT-BRISTOL-MYERS SQUIBB COMPANY-12999959 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Abilify PS Otsuka Initial or Prolonged Extrapyramidal Disorder Pharmaceutical Company, Ltd. ORAL Date:06/21/05ISR Number: 4695943-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000310 Age:28 YR Gender:Male I/FU:I Outcome PT Other Blood Cholesterol Increased 22-Feb-2006 08:31 AM Page: 851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Sodium Decreased Blood Triglycerides Increased Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Abilify PS Otsuka Non-Insulin-Dependent Pharmaceutical High Density Lipoprotein Company, Ltd. Decreased Clonidine C Topamax C Correctol C Zantac C Claritin C Date:06/23/05ISR Number: 4698013-8Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12828570 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Abilify PS Otsuka Fatigue Pharmaceutical Hallucination, Auditory Company, Ltd. Menorrhagia Epilim SS Musculoskeletal Stiffness Nausea Pituitary Tumour Psychotic Disorder Somnolence Weight Increased Date:06/23/05ISR Number: 4698046-1Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12975983 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Abilify PS Otsuka Life-Threatening Convulsion Pharmaceutical Dyspnoea Company, Ltd. ORAL Pulmonary Embolism Abilify SS Otsuka Shock Pharmaceutical Company, Ltd. ORAL Fluoxetine C Contraceptive C Date:06/23/05ISR Number: 4698047-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13003074 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Prozac C Date:06/23/05ISR Number: 4698049-7Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12987236 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify PS Otsuka Initial or Prolonged Sleep Disorder Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day; 22-Feb-2006 08:31 AM Page: 852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report titrated up to 20 mg/day on Fluanxol C Date:06/23/05ISR Number: 4698225-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12806022 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Abilify PS Otsuka Retinal Disorder Pharmaceutical Company, Ltd. ORAL 15 mg then reduced to 10 mg/day 6 WK Paracetamol C Flomax C Date:06/23/05ISR Number: 4698228-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000997 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Agitation Pharmaceutical Other Asthenia Company, Ltd. Dosage Blood Creatine increased to Phosphokinase Increased 10 mg one Body Temperature tablet once a Increased day around Dyskinesia Lithium C Fall Multivitamin C Movement Disorder Laxatives C Date:06/23/05ISR Number: 4698233-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13002837 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify PS Otsuka Convulsion Pharmaceutical Excitability Company, Ltd. ORAL Increased to Insomnia 10 mg/day. Sedation Sodium Valproate C Weight Decreased Date:06/23/05ISR Number: 4698328-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13004544 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day 22-Feb-2006 08:31 AM Page: 853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/05ISR Number: 4698334-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13004551 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg and then increased to 15 mg daily Date:06/23/05ISR Number: 4698512-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12864567 Age:45 WK Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Femur Fracture Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:06/24/05ISR Number: 4699062-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12938320 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Blood Magnesium Decreased Pharmaceutical Other Blood Magnesium Increased Company, Ltd. 2 YR Bradycardia Propafenone SS Cardiac Arrest Celxa C ORAL Electrocardiogram Qt Digoxin C ORAL Corrected Interval Labetalol C Prolonged Norvasc C Headache Lopressor C ORAL Hyperlipidaemia Coumadin C Bristol-Myers Squibb Hypertension Company Lobar Pneumonia Maxzide C Oedema Verapamil 80 C ORAL Palpitations Depakote C ORAL Renal Failure Hydralazine C ORAL Syncope Torsade De Pointes Urinary Tract Infection Ventricular Tachycardia Date:06/27/05ISR Number: 4700076-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006580 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/27/05ISR Number: 4701722-5Report Type:Expedited (15-DaCompany Report #2005083576 Age:25 YR Gender:Male I/FU:I Outcome PT Other Drug Ineffective Extrapyramidal Disorder 22-Feb-2006 08:31 AM Page: 854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Visual Oropharyngeal Spasm Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Zeldox Health (Ziprasidone) PS ORAL 120 MG (1 IN Professional 1 D), ORAL Other Abilify (Aripiprazole) SS ORAL 15 MG (1 IN 1 D), ORAL Zolpidem (Zolpidem) SS ORAL 10 MG (1 IN 1 D), ORAL Temesta (Lorazepam) SS ORAL 5 MG (1 IN 1 D), ORAL Date:06/28/05ISR Number: 4700994-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13007745 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Abilify PS Otsuka Other Sudden Death Pharmaceutical Company, Ltd. ORAL 4 MON Date:06/28/05ISR Number: 4701347-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12990008 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Xanax C Tercian C Date:06/29/05ISR Number: 4702433-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13009709 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Abilify PS Otsuka Initial or Prolonged Dystonia Pharmaceutical Musculoskeletal Stiffness Company, Ltd. Klonopin C Date:06/29/05ISR Number: 4703078-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006044 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 5 Mg PS Otsuka Life-Threatening Drug Interaction Pharmaceutical Hospitalization - Hepatic Mass Company, Ltd. ORAL Initial or Prolonged Loss Of Consciousness Clozaril I Other Nausea Somnolence Urinary Tract Infection Vomiting 22-Feb-2006 08:31 AM Page: 855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/05ISR Number: 4703079-2Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12874301 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Abilify PS Otsuka Other Asthma Pharmaceutical Company, Ltd. Morphine SS Chlorpromazine SS Benzodiazepines SS Date:06/29/05ISR Number: 4703084-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12931341 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Abilify PS Otsuka Other Cerebral Infarction Pharmaceutical Convulsion Company, Ltd. ORAL Diabetic Hyperosmolar Coma Nausea Pancreatitis Acute Pulmonary Oedema Renal Tubular Necrosis Subclavian Artery Thrombosis Vomiting Date:06/29/05ISR Number: 4703156-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12989166 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:06/29/05ISR Number: 4703160-8Report Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-13011697 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Abilify PS Otsuka Initial or Prolonged Fatigue Pharmaceutical Headache Company, Ltd. Musculoskeletal Stiffness Nausea Tongue Disorder Tremor Date:06/29/05ISR Number: 4703166-9Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13013099 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/05ISR Number: 4703185-2Report Type:Expedited (15-DaCompany Report #2005PK01103 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22 DAY Seroquel SS Zeneca Pharmaceutical ORAL 13 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL Abilify SS ORAL 39 DAY Abilify SS ORAL Date:06/30/05ISR Number: 4703516-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12910998 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Abilify Oral Urinary Retention Solution PS Bristol-Myers Squibb Company ORAL Date:06/30/05ISR Number: 4703517-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12963997 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Abilify Oral Solution 1 Mg/Ml PS Bristol-Myers Squibb Company ORAL Dose = 1/2 tsp once daily Novolog C Lantus C Date:06/30/05ISR Number: 4703698-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993390 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Abilify PS Otsuka Hospitalization - Appendicitis Pharmaceutical Initial or Prolonged Bradycardia Company, Ltd. 2 YR Other Carbon Dioxide Decreased Hypoxia Nausea Peritonitis Respiratory Distress Sepsis Tachycardia 22-Feb-2006 08:31 AM Page: 857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/05ISR Number: 4703699-5Report Type:Expedited (15-DaCompany Report #AT-BRISTOL-MYERS SQUIBB COMPANY-13011606 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Insomnia Pharmaceutical Logorrhoea Company, Ltd. ORAL Mania Lamictal C ORAL Thinking Abnormal Solian C ORAL Decreased to 400 mg/day from 25-Jan-2005 to Date:06/30/05ISR Number: 4704081-7Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13010269 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify PS Otsuka Erythema Multiforme Pharmaceutical Company, Ltd. Clozaril I ORAL 16 DAY Olanzapine I ORAL Date:06/30/05ISR Number: 4714282-XReport Type:Periodic Company Report #385724 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Consumer Klonopin Other (Clonazepam) PS ORAL 8 MG DAILY ORAL Abilify (Aripiprazole) SS ORAL 5 MG DAILY ORAL Lexapro (Escitalopram) SS ORAL 15 MG DAILY ORAL Trileptal (Oxcarbazepine) SS 900 MG DAILY Zocor (Simvastatin) C Date:07/01/05ISR Number: 4704992-2Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13010269 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify PS Otsuka Erythema Multiforme Pharmaceutical Company, Ltd. Clozaril I ORAL 16 DAY Olanzapine I ORAL Date:07/05/05ISR Number: 4706337-0Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13015938 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Abilify PS Otsuka Initial or Prolonged Prescribed Overdose Pharmaceutical Company, Ltd. ORAL Increased to 22-Feb-2006 08:31 AM Page: 858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 45 mg/d on 31-Dec-04 and continuing. Seroquel SS ORAL Initiated at 400mg on 08-Oct-04/350 mg(13-18-Oct) /300mg(19-09- Date:07/05/05ISR Number: 4706370-9Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13014972 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Photopsia Abilify PS Otsuka Initial or Prolonged Vision Blurred Pharmaceutical Company, Ltd. Initiated on 10mg on 09-Feb/increa sed to 15mg from 10-Feb Tavor SS Varying dosages from 3.5 mg on 09-Feb to 0.5 mg on Date:07/05/05ISR Number: 4706379-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13002837 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Abilify PS Otsuka Convulsion Pharmaceutical Excitability Company, Ltd. ORAL Increased to Insomnia 10 mg/day. Sedation Sodium Valproate C ORAL 20 YR Weight Decreased Omeprazole C ORAL Citalopram C ORAL Zopiclone C ORAL Lorazepam C ORAL Date:07/05/05ISR Number: 4706653-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13013479 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Musculoskeletal Stiffness Abilify Tabs PS Otsuka Pharyngitis Streptococcal Pharmaceutical Tremor Company, Ltd. 5 mg on 15-Jun-05, and 17-Jun-05 (last dose); dose skipped Ritalin-Sr C ORAL 2 YR 22-Feb-2006 08:31 AM Page: 859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/05ISR Number: 4707001-4Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12941514 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS Otsuka Initial or Prolonged Drug Abuser Pharmaceutical Company, Ltd. ORAL Date:07/06/05ISR Number: 4707580-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006580 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Abilify PS Otsuka Hospitalization - Blood Potassium Increased Pharmaceutical Initial or Prolonged Death Company, Ltd. Depressed Level Of Consciousness Dyspnoea Psychotic Disorder Date:07/06/05ISR Number: 4709555-0Report Type:Expedited (15-DaCompany Report #2005083576 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Foreign Zeldox Drug Ineffective Health Extrapyramidal Disorder Professional (Ziprasidone) PS ORAL 120 MG (1 IN Hallucination, Visual Other 1 D), ORAL Hypokinesia Abilify Laryngospasm (Aripiprazole) SS ORAL 15 MG (1 IN 1 Thinking Abnormal D), ORAL Zolpidem (Zolpidem) SS ORAL 10 MG (1 IN 1 D), ORAL Temesta (Lorazepam) SS ORAL 5 MG (1 IN 1 D), ORAL Date:07/08/05ISR Number: 4710180-6Report Type:Direct Company Report #CTU 252783 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Abilify 5 Mg PS 1/2 (5MG) QD X 1 WK THEN INCREASED TO 1 TAB QD Pemoline C Date:07/11/05ISR Number: 4710716-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13019906 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL initial dose of 5mg on 22-Feb-2006 08:31 AM Page: 860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 08/17/04, increased to 15 mg on 2 MON Effexor C Desyrel C Apothecon Date:07/11/05ISR Number: 4710787-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13024476 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:07/11/05ISR Number: 4710973-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13019427 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Hospitalization - Pulmonary Embolism Pharmaceutical Initial or Prolonged Company, Ltd. Date:07/11/05ISR Number: 4712797-1Report Type:Direct Company Report #CTU 252982E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Abilify PS 15 MG ONCE Aggression DAILY (SEE Anger B5) Condition Aggravated Carnitine C Convulsion Coenzyme Q 10 C Hallucination, Auditory Topamax C Hallucination, Visual Lithium C Insomnia Melatonin C Mania Paranoia Suicide Attempt Date:07/12/05ISR Number: 4711655-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13005335 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Abilify PS Otsuka Initial or Prolonged Mania Pharmaceutical Other Psychotic Disorder Company, Ltd. ORAL Decreased to 7.5 mg/day Clozapine C ORAL 3 YR Date:07/12/05ISR Number: 4712193-7Report Type:Expedited (15-DaCompany Report #AT-BRISTOL-MYERS SQUIBB COMPANY-13024559 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Abilify PS Otsuka Nystagmus Pharmaceutical Vertigo Company, Ltd. Truxal C 22-Feb-2006 08:31 AM Page: 861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/05ISR Number: 4712791-0Report Type:Direct Company Report #CTU 253038E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Abilify PS Date:07/13/05ISR Number: 4713880-7Report Type:Expedited (15-DaCompany Report #S05-USA-02250-01 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Consumer Lexapro Hospitalization - Depression (Escitalopram) PS ORAL 20 MG QD PO Initial or Prolonged Drug Ineffective Lithium SS 600 MG QD Mania Lamictal Multiple Drug Overdose (Lamotrigine) SS 50 MG BID Personality Change Abilify Suicide Attempt (Aripiprazole) SS 15 MG QD Weight Increased Seroquel (Quetiapine Fumarate) SS Trazodone SS Date:07/13/05ISR Number: 4714054-6Report Type:Direct Company Report #CTU 253131 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Abilify 20 Mg Intervention to Libido Increased Otsuka/Bristol Myers Prevent Permanent Priapism Squibb PS Otsuka/Bristol Myers Impairment/Damage Squibb ORAL 20 MG DAILY ORAL Prilosec C Calcium W/ Vitamin D C Nasonex Nasal Spray C Loratadine C Multivitamin C Bisacodyl Tablets C Lorazapam C Cozaar C Date:07/13/05ISR Number: 4714749-4Report Type:Expedited (15-DaCompany Report #S05-USA-02782-01 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Health Lexapro Professional (Escitalopram) PS ORAL 10 MG QD PO Company Lexapro Representative (Escitalopram) SS ORAL 20 MG QD PO Lexapro (Escitalopram) SS Prozac (Fluoxetine Hydrochloride) SS ORAL 80 MG QD PO Prozac (Fluoxetine Hydrochloride) SS ORAL 20 MG QD PO Prozac (Fluoxetine Hydrochloride) SS ORAL 40 MG QD PO Abilify (Aripiprazole) SS 30 MG QHS Depakote (Valproate Semisodium) C 22-Feb-2006 08:31 AM Page: 862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lisinopril C Diovan (Valsartan) C Coreg (Carvedilol) C Wellbutrin (Bupropion Hydrochloride) C Hydrocodone/Apap C Date:07/14/05ISR Number: 4714173-4Report Type:Expedited (15-DaCompany Report #2005PK00842 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel I Zeneca Pharmaceutical ORAL 6 DAY Seroquel I Zeneca Pharmaceutical ORAL 22 DAY Seroquel I Zeneca Pharmaceutical ORAL 13 DAY Seroquel I Zeneca Pharmaceutical ORAL 37 DAY Seroquel I Zeneca Pharmaceutical ORAL Abilify I ORAL 40 DAY Abilify I ORAL Date:07/15/05ISR Number: 4714724-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028196 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 8 MON Date:07/15/05ISR Number: 4714727-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13025150 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intra-Uterine Death Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Lexapro C Date:07/18/05ISR Number: 4715644-7Report Type:Expedited (15-DaCompany Report #2005PK01103 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22 DAY Seroquel SS Zeneca Pharmaceutical ORAL 13 DAY Seroquel SS Zeneca 22-Feb-2006 08:31 AM Page: 863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL Abilify SS ORAL 39 DAY Abilify SS ORAL Date:07/18/05ISR Number: 4716052-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13027214 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Abilify Tabs 15 Mg PS Otsuka Other Increased Pharmaceutical Convulsion Company, Ltd. ORAL Glasgow Coma Scale Abnormal Hypotension Renal Failure Tachycardia Date:07/19/05ISR Number: 4716682-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13033113 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify Tabs 15 Mg PS Otsuka Headache Pharmaceutical Insomnia Company, Ltd. ORAL Loss Of Consciousness Date:07/19/05ISR Number: 4716796-5Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0387922A Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Paracetamol PS Unk Manufacturer ORAL 500MG See Increased dosage text Overdose Abilify SS Bristol-Myers Squibb ORAL 60MG per day Date:07/19/05ISR Number: 4717023-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13014915 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day from 20-Jun to 26-Jun-2005 1 YR Citalopram C ORAL Trazodone Hcl C Apothecon ORAL Dosaeg: reduced to 100mg daily on 20-Jun-2005 Zopiclone C ORAL Dosage: reduced to 3.75mg daily on 20-Jun-2005 22-Feb-2006 08:31 AM Page: 864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Promethazine C ORAL Dosage: 25-50mg daily as needed Diazepam C ORAL Date:07/19/05ISR Number: 4717024-7Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12992434 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. Date:07/19/05ISR Number: 4717214-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE02527 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Leponex / Clozaril Laryngospasm (Clozapine) PS Novartis Sector: Leukopenia Pharma ORAL Lymphadenopathy Olanzapine SS ORAL 30 mg/day Oculogyration Risperidone SS ORAL 6 mg/day Pyrexia Aripiprazole SS ORAL 10 mg/day Date:07/19/05ISR Number: 4717247-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12997128 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disseminated Abilify PS Otsuka Life-Threatening Intravascular Coagulation Pharmaceutical Hospitalization - Insomnia Company, Ltd. ORAL 3 WK Initial or Prolonged Neuroleptic Malignant Lovenox C Syndrome Stelazine C 20 YR Date:07/19/05ISR Number: 4718704-XReport Type:Expedited (15-DaCompany Report #S05-USA-02675-01 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Lexapro Initial or Prolonged Condition Aggravated (Escitalopram) PS ORAL 50 MG QD PO Depression Lexapro Drug Ineffective (Escitalopram) SS ORAL 10 MG QD PO Hallucination Lexapro Intentional Misuse (Escitalopram) SS ORAL 20 MG QD PO Overdose Lexapro Post-Traumatic Stress (Escitalopram) SS ORAL 30 MG QD PO Disorder Lexapro Suicidal Ideation (Escitalopram) SS ORAL 40 MG QD PO Suicide Attempt Lexapro Treatment Noncompliance (Escitalopram) SS ORAL 50 MG QD PO Lexapro (Escitalopram) SS ORAL 30 MG QD PO Elavil (Amitriptyline Hydrochloride) SS 50 MG QD Klonopin (Clonazepam) SS 1 MG QD 22-Feb-2006 08:31 AM Page: 865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ritalin (Methylphenidate Hydrochloride) SS 30 MG QD Abilify (Aripiprazole) SS Geodon(Ziprasidone Hydrochloride) SS ORAL 40 MG QD PO Date:07/19/05ISR Number: 4719531-XReport Type:Direct Company Report #CTU 253609 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Aripiprazole 30 Mg PS ORAL 30 MG HS ORAL Insomnia Clonazepam C Furosemide C Simvastatin C Date:07/20/05ISR Number: 4718317-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13036678 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Facial Palsy Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:07/20/05ISR Number: 4718561-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000997 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Agitation Pharmaceutical Other Asthenia Company, Ltd. ORAL Dosage Blood Creatine increased to Phosphokinase Increased 10 mg one Body Temperature tablet once a Increased day around 1 MON Cognitive Disorder Lithium C Dyskinesia Multivitamin C Fall Laxatives C Movement Disorder Zantac C Dose Value: 150 Surfak C Date:07/20/05ISR Number: 4719176-1Report Type:Expedited (15-DaCompany Report #DSA_26729_2005 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Photopsia Foreign Tavor PS ORAL 3.5 MG PO Initial or Prolonged Vision Blurred Health Tavor SS ORAL 4 MG PO Professional Tavor SS ORAL 3 GM Q DAY PO Other Tavor SS ORAL 2.5 MG PO Tavor SS ORAL 2 MG Q DAY PO Tavor SS ORAL 1 MG Q DAY PO Tavor SS ORAL 0.5 MG PO Abilify SS ORAL 10 MG PO Abilify SS ORAL 15 MG Q DAY PO 22-Feb-2006 08:31 AM Page: 866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS ORAL 10 MG Q DAY PO Date:07/21/05ISR Number: 4719566-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13039862 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Blinded: Initial or Prolonged Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Blinded: Placebo SS ORAL Omeprazole C ORAL Cetirizine Hcl C ORAL Albuterol C RESPIRATORY (INHALATION) Ibuprofen C Date:07/21/05ISR Number: 4720587-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939500 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Abilify PS Otsuka Initial or Prolonged Drug Interaction Pharmaceutical Other Schizophrenia Company, Ltd. ORAL Zoplicone C Fluoxetine I Date:07/21/05ISR Number: 4720591-0Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13037148 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day Risperdal C ORAL Tranxilium C ORAL Date:07/22/05ISR Number: 4722615-3Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13040175 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Impulse-Control Disorder Abilify PS Otsuka Hospitalization - Intentional Self-Injury Pharmaceutical Initial or Prolonged Company, Ltd. Zyprexa C Date:07/22/05ISR Number: 4722617-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13040266 Age:46 YR Gender:Female I/FU:I Outcome PT Hospitalization - Illusion Initial or Prolonged Insomnia Nausea Oral Infection 22-Feb-2006 08:31 AM Page: 867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Carbamazepine C Sulpiride C Olanzapine C Date:07/22/05ISR Number: 4722886-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12962478 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Anger Pharmaceutical Condition Aggravated Company, Ltd. ORAL Insomnia Paranoia Personality Change Psychotic Disorder Date:07/25/05ISR Number: 4723390-9Report Type:Expedited (15-DaCompany Report #PHEH2005US06346 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Ritalin PS Novartis Sector: Hospitalization - Drug Ineffective Pharma ORAL 30 mg, QD Initial or Prolonged Hallucination Lexapro SS ORAL 10 mg, QD 10080MIN Other Overdose Lexapro SS ORAL 20 mg, QD 10080MIN Post-Traumatic Stress Lexapro SS ORAL 30 mg, QD 10080MIN Disorder Lexapro SS ORAL 40 mg, QD 10080MIN Suicidal Ideation Lexapro SS ORAL 50 mg, QD Suicide Attempt Lexapro SS ORAL 30 mg, QD Lexapro SS ORAL 50 mg, QD Elavil SS ORAL 50 mg, QD Klonopin SS ORAL 1 mg, QD 341 DAY Abilify SS ORAL UNK, UNK 135 DAY Geodon SS ORAL 40 mg, QD 46080MIN Date:07/25/05ISR Number: 4726122-3Report Type:Direct Company Report #CTU 254228 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Erythematous Aripiprazole 10 Mg/Tab ( ) Po Take One Daily PS ORAL 10 MG Q HS PO Seroquel C Loratadine C Tylenol C Lamisil C Ultram C Lithium Carb C Prilosec C Combivent Inh C 22-Feb-2006 08:31 AM Page: 868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/05ISR Number: 4724274-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12997128 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Abilify PS Otsuka Life-Threatening Deep Vein Thrombosis Pharmaceutical Hospitalization - Disseminated Company, Ltd. ORAL 3 WK Initial or Prolonged Intravascular Coagulation Lovenox C Encephalopathy Stelazine C 20 YR Heparin-Induced Stelazine C 20 YR Thrombocytopenia Heparin C Insomnia Neuroleptic Malignant Syndrome Pulmonary Embolism Date:07/26/05ISR Number: 4724958-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-410971 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Klonopin PS Roche UNKNOWN Initial or Prolonged Drug Effect Decreased Klonopin SS Roche UNKNOWN OVERDOSE Hallucination THERAPY. Post-Traumatic Stress Lexapro SS ORAL 7 DAY Disorder Lexapro SS ORAL 7 DAY Suicidal Ideation Lexapro SS ORAL 7 DAY Suicide Attempt Lexapro SS ORAL 7 DAY Lexapro SS ORAL Lexapro SS ORAL Lexapro SS ORAL Elavil SS UNKNOWN Ritalin SS UNKNOWN Abilify SS UNKNOWN 104 DAY Geodon SS ORAL Date:07/27/05ISR Number: 4726088-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12898516 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Abilify PS Otsuka Crohn'S Disease Pharmaceutical Vasculitis Company, Ltd. ORAL Initiated at 2.5 mg/day 10 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 2.5 mg/day 10 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 2.5 mg/day 10 MON Strattera C 10 MON Celexa C 10 MON 22-Feb-2006 08:31 AM Page: 869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/05ISR Number: 4727128-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12982526 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Diarrhoea Pharmaceutical Dizziness Company, Ltd. ORAL Dosage Excitability reduced on Headache 25-May-2005 Insomnia Prozac C Muscle Contractions Largactil C Involuntary Anafranil C Nausea Stilnox C Weight Decreased Date:07/28/05ISR Number: 4727132-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13041348 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Confusional State Pharmaceutical Cough Company, Ltd. ORAL Schizophrenia Clozaril C Tardive Dyskinesia Prolixin Decanoate Tremor Inj C INTRAMUSCULAR Naltrexone C Ativan C Hydroxyzine C Lamictal C Lexapro C Date:07/28/05ISR Number: 4727168-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13039862 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombophlebitis Blinded: Initial or Prolonged Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Blinded: Placebo SS ORAL Omeprazole C ORAL Cetirizine Hcl C ORAL Albuterol C RESPIRATORY (INHALATION) Ibuprofen C Date:07/28/05ISR Number: 4727551-4Report Type:Direct Company Report #CTU 254653 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperkalaemia Lisinopril 20mg PS ORAL 20MG QAM Intervention to ORAL Prevent Permanent Abilify 10mg SS ORAL 10MG QDAY Impairment/Damage ORAL Bupropion C Trazodone C Ecasa C Mvi C 22-Feb-2006 08:31 AM Page: 870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/05ISR Number: 4728134-2Report Type:Direct Company Report #CTU 254619 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Abilify 15mg Hs Pancreatitis Others PS Date:07/29/05ISR Number: 4728092-0Report Type:Expedited (15-DaCompany Report #PHBS2004US01841 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Clozapine PS Novartis Sector: Dysarthria Pharma UNKNOWN UNK, UNK Pleurothotonus Clozapine SS Novartis Sector: Tremor Pharma UNKNOWN 150 mg/d Venlafaxine (Ngx) SS UNKNOWN 375 mg/d Aripiprazole (Ngx) SS UNKNOWN 15 mg/d Lithium C UNKNOWN 450 mg/d Date:07/29/05ISR Number: 4728342-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12992434 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Amisulpride C Quetiapine C Duloxetine Hcl C Date:07/29/05ISR Number: 4728567-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12868386 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysuria Abilify PS Otsuka Initial or Prolonged Mental Impairment Pharmaceutical Company, Ltd. ORAL Dosage: 15mg daily 03-Jun-2004, 30mg daily 25-Jun-2004 Clozapine C ORAL Dosage: reducing by 25mg every 3rd day Date:07/29/05ISR Number: 4728790-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047253 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Abilify Tabs PS Otsuka Other Death Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/05ISR Number: 4728791-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13046586 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Sudden Death Pharmaceutical Company, Ltd. ORAL Date:07/29/05ISR Number: 4728794-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13046560 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Sudden Death Pharmaceutical Company, Ltd. ORAL Date:07/29/05ISR Number: 4728796-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13035746 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Other Schizophrenia Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Date:07/29/05ISR Number: 4729311-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13044599 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Cerebrovascular Accident Pharmaceutical Other Motor Dysfunction Company, Ltd. ORAL 1 YR Ritalin La C ORAL Inderal C ORAL Date:08/01/05ISR Number: 4730470-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13047808 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Abilify PS Otsuka Hospitalization - Hyponatraemia Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Glibenclamide C ORAL Metformin Hcl C Bristol-Myers Squibb Company Date:08/01/05ISR Number: 4730590-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13047782 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Agitation Pharmaceutical Insomnia Company, Ltd. ORAL Dose value: Paranoia 10 to 30 mg 3 MON Personality Change 22-Feb-2006 08:31 AM Page: 872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/05ISR Number: 4733188-3Report Type:Expedited (15-DaCompany Report #2005AL002863 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Papular Foreign Serax Initial or Prolonged Rash Pruritic Health (Oxazepam) PS ORAL 150 MG; QD; Professional PO Other Abilify () SS ORAL 15 MG ;QD; PO Noctran 10 () SS ORAL QD; PO Date:08/02/05ISR Number: 4731318-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047972 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Normal Newborn Abilify PS Otsuka Pregnancy Pharmaceutical Premature Baby Company, Ltd. Date:08/03/05ISR Number: 4733272-4Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13051842 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Abilify Tabs 15 Mg PS Otsuka Convulsion Pharmaceutical Hypertension Company, Ltd. ORAL Insomnia Nausea Vomiting Weight Decreased Date:08/03/05ISR Number: 4733275-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13013479 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify Tabs PS Otsuka Phosphokinase Increased Pharmaceutical Muscle Twitching Company, Ltd. 5 mg on Musculoskeletal Stiffness 15-Jun-05, Pharyngitis Streptococcal and 17-Jun-05 Tremor (last dose); dose skipped Ritalin La C ORAL Date:08/03/05ISR Number: 4733354-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13040266 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Illusion Abilify PS Otsuka Initial or Prolonged Insomnia Pharmaceutical Disability Nausea Company, Ltd. ORAL 43 WK Oral Infection Carbamazepine C Vomiting Sulpiride C Olanzapine C 22-Feb-2006 08:31 AM Page: 873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/05ISR Number: 4733359-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12784559 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Neonatal Abilify PS Otsuka Neonatal Respiratory Pharmaceutical Distress Syndrome Company, Ltd. TRANSPLACENTAL 31 WK Premature Baby Date:08/03/05ISR Number: 4734410-XReport Type:Direct Company Report #CTU 255252 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Aripiprazole PS Date:08/05/05ISR Number: 4735307-1Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13040175 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Foot Fracture Abilify PS Otsuka Hospitalization - Impulse-Control Disorder Pharmaceutical Initial or Prolonged Intentional Self-Injury Company, Ltd. Zyprexa C Date:08/05/05ISR Number: 4735336-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13056874 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Cogentin C 2 MON Concerta C 1 MON Date:08/05/05ISR Number: 4735707-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12998167 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Abilify PS Otsuka Initial or Prolonged Drug Ineffective Pharmaceutical Hallucination Company, Ltd. Intentional Misuse Lexapro SS ORAL Post-Traumatic Stress Elavil SS ORAL Disorder Klonopin SS Suicidal Ideation Ritalin SS Suicide Attempt Geodon SS ORAL Date:08/05/05ISR Number: 4738040-5Report Type:Direct Company Report #CTU 255593E Age:26 YR Gender:Male I/FU:I Outcome Life-Threatening Required Intervention to 22-Feb-2006 08:31 AM Page: 874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Asthenia 30mg Abilify Blood Triglycerides Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 1 X DAILY Increased ORAL Dizziness Advicor C Date:08/08/05ISR Number: 4736694-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13053962 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Aripiprazole PS Otsuka Papilloedema Pharmaceutical Company, Ltd. ORAL Zoloft SS ORAL Lipitor C Multivitamin C Date:08/08/05ISR Number: 4738303-3Report Type:Direct Company Report #CTU 255595 E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Abilify PS 30 QD Hospitalization - Circulatory Collapse Lamictal SS 250 BID Initial or Prolonged Coma .............. C Cough Drug Interaction Nervous System Disorder Psychotic Disorder Date:08/09/05ISR Number: 4738096-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13033113 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Abilify Tabs 15 Mg PS Otsuka Insomnia Pharmaceutical Syncope Company, Ltd. ORAL Molindone C ORAL Date:08/09/05ISR Number: 4738490-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13041348 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Confusional State Pharmaceutical Cough Company, Ltd. ORAL Dosage: 30mg, Psychotic Disorder then reduced Schizophrenia to 20mg, then Tardive Dyskinesia increased to Tremor 30mg 13 MON Clozaril C Prolixin Decanoate Inj C INTRAMUSCULAR Naltrexone C Ativan C Hydroxyzine C 22-Feb-2006 08:31 AM Page: 875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamictal C Lexapro C Date:08/10/05ISR Number: 4740911-0Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-13059613 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Aripiprazole PS Otsuka Loss Of Consciousness Pharmaceutical Company, Ltd. 1 DAY Date:08/10/05ISR Number: 4742887-9Report Type:Direct Company Report #CTU 255921 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Vasculitis Abilify 10 Mg PS ORAL TID ORAL Intervention to Depakote Er C Prevent Permanent Kcl C Impairment/Damage Furosemide C Lipitor C Manganese Tablet C Masonex C Mucinex C Niacin C Vitamins E And C C Levitra C Date:08/11/05ISR Number: 4742580-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-410971 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Klonopin PS Roche UNKNOWN 341 DAY Initial or Prolonged Hallucination Klonopin SS Roche UNKNOWN OVERDOSE Overdose THERAPY. Post-Traumatic Stress Lexapro SS ORAL 7 DAY Disorder Lexapro SS ORAL 7 DAY Self Injurious Behaviour Lexapro SS ORAL 7 DAY Suicidal Ideation Lexapro SS ORAL 7 DAY Suicide Attempt Lexapro SS ORAL Lexapro SS ORAL Lexapro SS ORAL Elavil SS UNKNOWN Ritalin SS UNKNOWN Ritalin SS UNKNOWN THE PATIENT WAS WEANED OFF THE DRUG. Abilify SS UNKNOWN 135 DAY Geodon SS ORAL 32 DAY Date:08/12/05ISR Number: 4743500-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB02168 Age:25 YR Gender:Male I/FU:F Outcome PT Other Electrocardiogram Abnormal Ventricular Pre-Excitation 22-Feb-2006 08:31 AM Page: 876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wolff-Parkinson-White Syndrome Report Source Product Role Manufacturer Route Dose Duration Clozapine PS Novartis Sector: Pharma ORAL 150 mg/day Clozapine SS Novartis Sector: Pharma Aripiprazole SS Haloperidol C Procyclidine C Date:08/12/05ISR Number: 4744270-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13025150 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Abilify PS Otsuka Initial or Prolonged Pregnancy Pharmaceutical Other Intra-Uterine Death Company, Ltd. ORAL 2 MON Pregnancy Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Lexapro C ORAL Dose incr to 20 mg 18-Nov-2004 to 25-Feb-2005,1 Date:08/15/05ISR Number: 4744693-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12899621 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Abilify Tabs 15 Mg PS Otsuka Other Phosphokinase Increased Pharmaceutical Cardiac Arrest Company, Ltd. ORAL Electrocardiogram St Lepticur SS Segment Elevation Rivotril SS Fall Tercian SS ORAL Hyperkalaemia Lipanthyl SS ORAL Malaise Risperdal SS Psychomotor Hyperactivity Respiratory Arrest Date:08/15/05ISR Number: 4744732-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13065412 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foetal Alcohol Syndrome Abilify PS Otsuka Other Intra-Uterine Death Pharmaceutical Stillbirth Company, Ltd. TRANSPLACENTAL Trisomy 21 Lexapro C TRANSPLACENTAL Dose incr to Umbilical Cord 20 mg Abnormality 18-Nov-2004 to 25-Feb-2005,1 22-Feb-2006 08:31 AM Page: 877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/05ISR Number: 4744975-XReport Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12941514 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify PS Otsuka Initial or Prolonged Drug Abuser Pharmaceutical Disability Company, Ltd. ORAL Duration: 7-10 days 7 DAY Date:08/15/05ISR Number: 4745813-1Report Type:Direct Company Report #CTU 256181 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Abilify PS ORAL 5MG THEN 10MG DAILY ORAL Effexor Xr SS ORAL 75 MG DAILY ORAL Date:08/16/05ISR Number: 4746025-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12997128 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Abilify PS Otsuka Life-Threatening Increased Pharmaceutical Hospitalization - Aspartate Company, Ltd. ORAL Dosage: 10 mg Initial or Prolonged Aminotransferase - one-half to Increased one tablet Blood Urine Present daily 3 WK Cardio-Respiratory Arrest Lovenox C Deep Vein Thrombosis Stelazine C 24 YR Disseminated Stelazine C 24 YR Intravascular Coagulation Heparin C Encephalopathy Heparin-Induced Thrombocytopenia Insomnia Ketonuria Loss Of Consciousness Mania Neuroleptic Malignant Syndrome Pulmonary Embolism Somnolence Date:08/16/05ISR Number: 4746569-9Report Type:Direct Company Report #CTU 256281 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Contractions Abilify PS 10 MG TAB Involuntary Luvox C Tremor Benadryl C Date:08/17/05ISR Number: 4747528-2Report Type:Direct Company Report #CTU 256342 Age:43 YR Gender:Female I/FU:I Outcome Other Required 22-Feb-2006 08:31 AM Page: 878 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 Activities Of Daily Abilify Unknown Living Impaired Bristol Meyer PS Bristol Meyer ORAL CAN'T Arthropathy REMEMBER ORAL Cardiac Disorder Feeling Abnormal Weight Increased Date:08/17/05ISR Number: 4747862-6Report Type:Direct Company Report #CTU 256368 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Aripriprazole PS ORAL 10 MG ORAL Musculoskeletal Stiffness Sertraline C Augmentin C Lorazepam C Date:08/18/05ISR Number: 4748208-XReport Type:Expedited (15-DaCompany Report #KR-BRISTOL-MYERS SQUIBB COMPANY-12919031 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:08/19/05ISR Number: 4748912-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13065982 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Abilify PS Otsuka Antidiuretic Hormone Pharmaceutical Secretion Company, Ltd. Date:08/19/05ISR Number: 4749211-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13053962 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Aripiprazole PS Otsuka Papilloedema Pharmaceutical Company, Ltd. ORAL Zoloft SS ORAL Lipitor C Multivitamin C Date:08/22/05ISR Number: 4749677-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE02527 Age:46 YR Gender:Male I/FU:F Outcome PT Life-Threatening Hodgkin'S Disease Hospitalization - Laryngospasm Initial or Prolonged Leukopenia Other Lymphadenopathy Neutropenia Neutrophilia 22-Feb-2006 08:31 AM Page: 879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oculogyration Pyrexia Surgery Report Source Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL up to 600 mg, QD Olanzapine SS ORAL 30 mg/day Risperdal SS ORAL 3 mg, QD 98 DAY Aripiprazole SS ORAL 10 mg/day Tavor C UNKNOWN 1.5 mg - 3 mg/day Agopton C ORAL 30 mg, QD 100 DAY Gastrozepin C ORAL 50 mg, QD 28800MIN Date:08/22/05ISR Number: 4749767-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000310 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Abilify PS Otsuka Increased Pharmaceutical Blood Sodium Decreased Company, Ltd. ORAL 6 MON Blood Triglycerides Clonidine C Increased Topamax C Diabetes Mellitus Correctol C Non-Insulin-Dependent Zantac C High Density Lipoprotein Claritin C Decreased Date:08/23/05ISR Number: 4750334-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12558664 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify PS Otsuka Initial or Prolonged Diabetes Mellitus Pharmaceutical Disability Insulin-Dependent Company, Ltd. ORAL 24 DAY Drug Ineffective Zyprexa C Dose Value: Nausea 1.25-7.5 Urine Ketone Body Present Zoloft C Clonidine C Ddavp C Tenex C Melatonin C Date:08/23/05ISR Number: 4750661-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13072731 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar Disorder Abilify PS Otsuka Hospitalization - Death Pharmaceutical Initial or Prolonged Prescribed Overdose Company, Ltd. Risperdal C 22-Feb-2006 08:31 AM Page: 880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4750663-6Report Type:Expedited (15-DaCompany Report #SK-BRISTOL-MYERS SQUIBB COMPANY-13074158 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Amisulpridum C Date:08/23/05ISR Number: 4750666-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13075668 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Abilify Tabs PS Otsuka Rash Pustular Pharmaceutical Company, Ltd. ORAL 127 DAY Atarax SS ORAL Lepticur SS ORAL 3 DAY Date:08/23/05ISR Number: 4750673-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13075114 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Abilify PS Otsuka Loss Of Consciousness Pharmaceutical Thinking Abnormal Company, Ltd. Vision Blurred Clozapine C Vomiting Xanthopsia Date:08/23/05ISR Number: 4750680-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13078951 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:08/23/05ISR Number: 4750694-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13074968 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Abilify PS Otsuka Fear Pharmaceutical Somnolence Company, Ltd. ORAL Dose value: Vision Blurred 10 to 30 mg 13 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Dose value: 10 to 30 mg 13 DAY Lithium Carbonate C ORAL Lithium Carbonate C ORAL Valproic Acid C ORAL Valproic Acid C ORAL Olanzapine C Olanzapine C Salactol C TOPICAL Diltiazem Hcl C 22-Feb-2006 08:31 AM Page: 881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diltiazem Hcl C Date:08/24/05ISR Number: 4751480-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13079884 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Abilify Tabs 10 Mg PS Otsuka Dystonia Pharmaceutical Inappropriate Affect Company, Ltd. ORAL Mydriasis Seroquel C Tremor Melatonin C 2 WK Date:08/24/05ISR Number: 4751603-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13079090 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Abilify PS Otsuka Initial or Prolonged Loss Of Consciousness Pharmaceutical Company, Ltd. Date:08/24/05ISR Number: 4751625-5Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050404025 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR Drug Exposure During Aripriprazol SS ORAL Pregnancy Aripriprazol SS ORAL Quetiapine C ORAL Chlorpramazine C ORAL Diazepam C ORAL Benzhexol C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Folic Acid C ORAL Date:08/24/05ISR Number: 4751649-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12748570 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Abilify PS Otsuka Anxiety Pharmaceutical Constipation Company, Ltd. Hyperhidrosis Risperidone C Insomnia Levothyroxine C Jaw Disorder Sodium Valproate C Self Injurious Behaviour Lithium C 22-Feb-2006 08:31 AM Page: 882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/05ISR Number: 4751701-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13078324 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Drug Intake By Abilify PS Otsuka Initial or Prolonged Child Pharmaceutical Accidental Exposure Company, Ltd. Drug Toxicity Trazodone Hcl Tabs SS Apothecon Clonidine SS Date:08/25/05ISR Number: 4754335-3Report Type:Direct Company Report #CTU 256927 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Abilify 15 Mg Intervention to Bristol Myer Prevent Permanent Squibb PS Bristol Myer Squibb ORAL 15 MG 2 Impairment/Damage TABS QAM PO Risperdal 1 Mg Janssen SS Janssen ORAL 1 MG 1 TAB BID PO Date:08/25/05ISR Number: 4754401-2Report Type:Direct Company Report #CTU 256940 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Abilify 15 Mg PS ORAL 15 MG QD Rash PO 1 MON Date:08/25/05ISR Number: 4754505-4Report Type:Direct Company Report #CTU 256930E Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Aripiprazole 5mg PS ORAL 5MG QAM PO 3 DAY Hospitalization - Syndrome Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:08/26/05ISR Number: 4753712-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082094 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Abilify PS Otsuka Initial or Prolonged Cerebrovascular Accident Pharmaceutical Other Chest Pain Company, Ltd. Heart Rate Increased Vasotec C Heart Rate Irregular Cymbalta C Pollakiuria Vitamins C Salivary Hypersecretion Cardizem C Thirst Transient Ischaemic Attack Visual Disturbance 22-Feb-2006 08:31 AM Page: 883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/05ISR Number: 4754569-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13048145 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Tachycardia Abilify PS Otsuka Initial or Prolonged Mental Disorder Pharmaceutical Company, Ltd. ORAL Dosage: increased to 15mg daily from 18-Jul-2005 Loxapac C Depakine Chrono C Rivotril C Date:08/29/05ISR Number: 4755149-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13082177 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Speech Disorder Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 16-Aug-2005 dose reduced to 10mg Solian C ORAL Date:08/29/05ISR Number: 4756159-XReport Type:Direct Company Report #CTU 257145 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify 30mg PS ORAL 45 MG HS Phosphokinase Increased PO Pyrexia White Blood Cell Count Increased Date:08/29/05ISR Number: 4757032-3Report Type:Direct Company Report #CTU 257140 E Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Abilify PS Initial or Prolonged Dysphagia Lithium C Vision Blurred Synthroid C Visual Disturbance Prozac C Date:08/29/05ISR Number: 4757145-6Report Type:Expedited (15-DaCompany Report #KII-2005-0018221 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Study Morphine Sulfate Initial or Prolonged Areflexia Health (Similar To Nda Other Multiple Drug Overdose Professional 19-516)(Morphine Somnolence Other Sulfate) Unknown PS ORAL ORAL Tachycardia Valproic Acid Vomiting (Valproic Acid) SS ORAL ORAL Lithium(Lithium) SS ORAL ORAL Acetaminophen(Parace tamol) SS ORAL ORAL 22-Feb-2006 08:31 AM Page: 884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine(Olanzapin e) SS ORAL ORAL Carisoprodol(Carisop rodol) SS ORAL ORAL Aripiprazole SS ORAL ORAL Hydrocodone(Hydrocod one) SS ORAL ORAL Benzodiazepine Derivatives SS ORAL ORAL Date:08/30/05ISR Number: 4755491-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12517694 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify PS Otsuka Hypersomnia Pharmaceutical Weight Increased Company, Ltd. ORAL Initial dose: 15 mg/day; decreased to 7.5 mg/day; increased to Date:08/30/05ISR Number: 4755492-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12527966 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL pt on ability "since the beginning of 2003". Topamax C Effexor C Trazodone Hcl C Apothecon Two tablets daily and three tablets nightly Date:08/30/05ISR Number: 4755493-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12622155 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Decreased Abilify Tabs 15 Mg PS Otsuka Diabetes Mellitus Pharmaceutical Dizziness Company, Ltd. ORAL Decreased to Dry Eye 10 mg/day on Heat Stroke 03-May-2005 3 YR Myocardial Infarction Klonopin C Nausea Calcium C Pollakiuria St John Wort C Rash St. Joseph Aspirin C Vomiting Ocean Mist C Weight Decreased 22-Feb-2006 08:31 AM Page: 885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755494-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12704169 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify PS Otsuka Initial or Prolonged Lower Limb Fracture Pharmaceutical Company, Ltd. ORAL low dose Date:08/30/05ISR Number: 4755495-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741849 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL Titrated 15mg to 0 mg/day at delivery and for 3 months after Prenatal Vitamins C Date:08/30/05ISR Number: 4755496-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12754370 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify Tabs 5 Mg PS Otsuka Dyspnoea Pharmaceutical Food Craving Company, Ltd. Hepatitis Abilify Tabs 5 Mg SS Otsuka Hunger Pharmaceutical Malaise Company, Ltd. Restlessness Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. Tegretol C Lorazepam C Lexapro C Vitamin E C Vitamin B Complex C Axert C Plaquenil C Nabumetone C Date:08/30/05ISR Number: 4755497-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12772380 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 15 Mg PS Otsuka Fear Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL Initiated at Hallucination, Visual 7.5 mg/day on Insomnia 30-Oct-04, Paranoia increased to Tremor 15 mg/day Lithium C Risperdal C Lasix C Calcitriol C Allopurinol C 22-Feb-2006 08:31 AM Page: 886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prilosec C Cozaar C Pindolol C Ativan C Ultram C Multivitamin C Date:08/30/05ISR Number: 4755498-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781274 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Deja Vu Pharmaceutical Delusion Company, Ltd. ORAL Increased to Drug Ineffective 30 mg/day on Psychotic Disorder 30-Nov-2004; then 20 mg (date not Depakote C Prolixin C Apothecon INTRAMUSCULAR Benadryl C Ativan C Date:08/30/05ISR Number: 4755499-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12819744 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify Tabs 5 Mg PS Otsuka Pregnancy Pharmaceutical Company, Ltd. ORAL 5 mg 08-Nov-04 to 18-Nov-04; 10 mg 24-Dec-04 to 07-Jan-05 15 DAY Date:08/30/05ISR Number: 4755500-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12836706 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755501-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12849618 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Menstruation Irregular Pharmaceutical Oedema Peripheral Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755502-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12854709 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphadenopathy Abilify PS Otsuka Tremor Pharmaceutical Weight Decreased Company, Ltd. ORAL 9 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 9 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 9 MON Vasotec C Zocor C Date:08/30/05ISR Number: 4755503-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12866653 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Confusional State Company, Ltd. ORAL Musculoskeletal Stiffness Abilify SS Otsuka Pyrexia Pharmaceutical Company, Ltd. ORAL Depakote C Ativan C Date:08/30/05ISR Number: 4755504-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12873329 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify PS Otsuka Sinusitis Pharmaceutical Company, Ltd. ORAL 1 WK Concerta C Clonidine C Date:08/30/05ISR Number: 4755505-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12895660 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 15 Mg PS Otsuka Nausea Pharmaceutical Obsessive-Compulsive Company, Ltd. ORAL Disorder Buspar Tabs 30 Mg C Restlessness Trileptal C Somnolence Tardive Dyskinesia Thought Blocking Visual Acuity Reduced Vomiting 22-Feb-2006 08:31 AM Page: 888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755506-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12895678 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Abilify Tabs 5 Mg PS Otsuka Drooling Pharmaceutical Moaning Company, Ltd. ORAL Psychomotor Retardation Abilify Tabs 5 Mg SS Otsuka Tremor Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Serzone C Bristol-Myers Squibb Company Clonidine C Date:08/30/05ISR Number: 4755507-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12901922 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Abilify PS Otsuka Blood Prolactin Increased Pharmaceutical Convulsion Company, Ltd. ORAL Prescribed Overdose Moban SS 150 mg/day Vision Blurred from 1997 to Weight Increased Sep-2003; decreased to 100 mg/day in Topamax C 150-200 mg twice daily Topamax C 150-200 mg twice daily Neurontin C Zarontin C ORAL 2-3 caps twice daily Benzatropine C ORAL Minocycline C ORAL Eskalith Cr C ORAL Date:08/30/05ISR Number: 4755508-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12905741 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Zoloft C Date:08/30/05ISR Number: 4755509-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12911640 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Morphine C Insulin C 22-Feb-2006 08:31 AM Page: 889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755510-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12912481 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs 5 Mg PS Otsuka Feeling Abnormal Pharmaceutical Hallucination Company, Ltd. ORAL Incoherent Zoloft C Thirst Lamictal C 6 MON Urine Output Increased Date:08/30/05ISR Number: 4755511-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12932042 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Abilify PS Otsuka Memory Impairment Pharmaceutical Priapism Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Depakote C Date:08/30/05ISR Number: 4755512-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12932125 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Wellbutrin Xl C ORAL Neurontin C ORAL Date:08/30/05ISR Number: 4755513-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12939807 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Company, Ltd. 1 YR Date:08/30/05ISR Number: 4755514-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12942165 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Complex Partial Seizures Pharmaceutical Eye Movement Disorder Company, Ltd. ORAL varying doses Tremor Wellbutrin Xl C 1 MON Strattera C Date:08/30/05ISR Number: 4755515-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12953519 Age:46 YR Gender:Female I/FU:I Outcome PT Dyspnoea Malaise 22-Feb-2006 08:31 AM Page: 890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vision Blurred Weight Increased Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day on 31-Mar-2005. Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 10 mg/day on 31-Mar-2005. Zoloft C Increased to 200 mg/day on 08-May-2005. Depakote C Date:08/30/05ISR Number: 4755516-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12954434 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Prozac C Date:08/30/05ISR Number: 4755517-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12954624 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Abilify PS Otsuka Anger Pharmaceutical Company, Ltd. Inc to 15 mg/day Lithium C Concerta C Date:08/30/05ISR Number: 4755518-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12955167 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Seroquel C Date:08/30/05ISR Number: 4755519-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12955324 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Pharmaceutical Company, Ltd. 3 WK Lithium C Lorazepam C Zyprexa C 22-Feb-2006 08:31 AM Page: 891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro C Date:08/30/05ISR Number: 4755520-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12956504 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 30 Mg PS Otsuka Fall Pharmaceutical Company, Ltd. ORAL 1 WK Date:08/30/05ISR Number: 4755521-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12956660 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Aripiprazole PS Otsuka Insomnia Pharmaceutical Company, Ltd. 10 mg tab once a night, then reduced to 5 mg at night Date:08/30/05ISR Number: 4755522-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12956702 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Aripiprazole PS Otsuka Initial or Prolonged Drooling Pharmaceutical Other Dysphagia Company, Ltd. ORAL 15 mg 5/25 to 5/27/04, 30 mg qd 5/28/04/ to 6/18/04, then Lorazepam C Benztropine C Date:08/30/05ISR Number: 4755523-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12956710 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Aripiprazole PS Otsuka Initial or Prolonged Dystonia Pharmaceutical Company, Ltd. ORAL Strattera C ORAL Date:08/30/05ISR Number: 4755524-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12956959 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Lamictal C 22-Feb-2006 08:31 AM Page: 892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755525-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12957098 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Agitation Pharmaceutical Anger Company, Ltd. Increased to 15 mg daily then discontinued. Carbatrol C Date:08/30/05ISR Number: 4755526-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12957981 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755527-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12958104 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755528-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12958211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. Lamictal C Parnate C Date:08/30/05ISR Number: 4755529-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12958823 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755530-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12958880 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Pneumonia Pharmaceutical Company, Ltd. ORAL 2 YR Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 YR Abilify Tabs 5 Mg SS Otsuka 22-Feb-2006 08:31 AM Page: 893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Company, Ltd. ORAL 2 YR Date:08/30/05ISR Number: 4755531-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12959359 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphemia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755532-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12960563 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Abilify PS Otsuka Drug Interaction Pharmaceutical Irritability Company, Ltd. Mood Swings Cytomel I Lexapro I Date:08/30/05ISR Number: 4755533-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12960837 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Abilify PS Otsuka Attack Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755534-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12960977 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Prolixin C Apothecon Valium C Date:08/30/05ISR Number: 4755535-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12961348 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Abilify PS Otsuka Fatigue Pharmaceutical Vision Blurred Company, Ltd. ORAL Also reported Weight Increased as 10 mg/day 1 YR Aspirin C Digoxin C Wellbutrin C 22-Feb-2006 08:31 AM Page: 894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755536-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12961645 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Abilify PS Otsuka No Adverse Effect Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755537-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12962429 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Abilify Tabs 5 Mg PS Otsuka Vomiting Projectile Pharmaceutical Company, Ltd. ORAL 1 DAY Zoloft C Date:08/30/05ISR Number: 4755538-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12963591 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Abilify Tabs PS Otsuka Initial or Prolonged Weight Decreased Pharmaceutical Other Company, Ltd. 1 YR Clonazepam C Lithium C Trileptal C Date:08/30/05ISR Number: 4755539-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12964524 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755540-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12964680 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Abilify PS Otsuka Blood Cholesterol Pharmaceutical Increased Company, Ltd. ORAL 1 YR Blood Glucose Increased Abilify SS Otsuka Memory Impairment Pharmaceutical Muscle Rigidity Company, Ltd. ORAL Nervousness Atenolol C Sandoz Inc. (Geneva Pain In Extremity Pharm Tech) Rheumatoid Arthritis Cymbalta C Weight Loss Poor Fosamax C Lamictal C Miralax C Mobic C Ritalin C Synthroid C Ultram C Zelnorm C Diclofenac C 22-Feb-2006 08:31 AM Page: 895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prozac C Date:08/30/05ISR Number: 4755542-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12964730 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Abilify PS Otsuka Initial or Prolonged Pharmaceutical Other Company, Ltd. Plavix C Regulatory Health Authority South Africa Ambien C Pepcid C Zocor C Klonopin C Wellbutrin Sr C Date:08/30/05ISR Number: 4755543-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12964797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755544-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12964847 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. 2.5 mg then incr to 5.0 mg then decr to 2.5 mg Date:08/30/05ISR Number: 4755545-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12964870 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. 4 WK Lithium C Date:08/30/05ISR Number: 4755546-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12965489 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify PS Otsuka Pharmaceutical Company, Ltd. Lipitor C Nardil C Xanax C 22-Feb-2006 08:31 AM Page: 896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755547-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12965661 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755548-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12965893 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Abilify PS Otsuka Hospitalization - Drug Ineffective Pharmaceutical Initial or Prolonged Intentional Misuse Company, Ltd. Mania Trazodone Hcl SS Apothecon Suicide Attempt Lexapro SS ORAL Weight Increased Lithium SS Lamictal SS Seroquel SS Date:08/30/05ISR Number: 4755549-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12966586 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Abilify PS Otsuka Emotional Distress Pharmaceutical Company, Ltd. ORAL dose increased from 10 mg/day Bethanechol C Flomax C Insulin 70/30 C Humulin 70/30 C Metformin Hcl C Bristol-Myers Squibb Company Glipizide C Tricor C Xanax C .25 mg 1 to 4 times daily Benzatropine C 1-2 per day Imipramine C Avandia C Wellbutrin C Date:08/30/05ISR Number: 4755550-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12966669 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755551-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12968012 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 MON Concerta C Date:08/30/05ISR Number: 4755552-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12968228 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Drug Withdrawal Syndrome Pharmaceutical Company, Ltd. Initiated September 04; Mother abruptly stopped Abilify SS Otsuka Pharmaceutical Company, Ltd. Initiated September 04; Mother abruptly stopped Adderall C Date:08/30/05ISR Number: 4755553-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12968392 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Abilify PS Otsuka Initial or Prolonged Nausea Pharmaceutical Oedema Peripheral Company, Ltd. Prozac C Zoloft C Date:08/30/05ISR Number: 4755554-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12969358 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Logorrhoea Pharmaceutical Overdose Company, Ltd. 2 MON Lortab C Soma C Date:08/30/05ISR Number: 4755555-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12970018 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755556-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12970240 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. ORAL 5 DAY Adderall Xr C Lithium C ORAL Date:08/30/05ISR Number: 4755557-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12971420 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify PS Otsuka Amenorrhoea Pharmaceutical Blister Company, Ltd. Constipation Lexapro SS ORAL Increased to Face Oedema 20 mg/day Hypomenorrhoea after 1 week Increased Tendency To of therapy. Bruise Lexapro SS ORAL Increased to Menorrhagia 20 mg/day Polymenorrhoea after 1 week Vision Blurred of therapy. Topamax C Ambien C Ativan C Date:08/30/05ISR Number: 4755558-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12971602 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Abilify PS Otsuka Irritability Pharmaceutical Social Avoidant Behaviour Company, Ltd. ORAL Strattera C Trileptal C Date:08/30/05ISR Number: 4755559-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12971669 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755560-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12971776 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mydriasis Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755561-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12971909 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755562-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12973327 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Effexor C Date:08/30/05ISR Number: 4755563-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12973392 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify PS Otsuka Pharmaceutical Company, Ltd. 3 WK Effexor C Date:08/30/05ISR Number: 4755564-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12973418 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755565-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12973426 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755566-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12973715 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Decreased to 1/2 tablet per day. Lexapro C 1 WK 22-Feb-2006 08:31 AM Page: 900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755567-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12973749 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Abilify Tabs PS Otsuka Initial or Prolonged Clumsiness Pharmaceutical Other Depression Company, Ltd. varying doses 2 YR Diarrhoea Abilify Tabs SS Otsuka Dizziness Pharmaceutical Hallucination, Auditory Company, Ltd. varying doses 2 YR Suicide Attempt Lamictal C Tardive Dyskinesia Depakote C Treatment Noncompliance Lexapro C Strattera C Wellbutrin C Ristoril C Magnesium Sulfate C Date:08/30/05ISR Number: 4755568-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12975157 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. 21 DAY Date:08/30/05ISR Number: 4755569-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12975348 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Prozac C Glucovance C Bristol-Myers Squibb Company Propanol C Hctz C Date:08/30/05ISR Number: 4755570-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12975470 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Abilify Tabs 10 Mg PS Otsuka Rash Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Ativan C Buspar C Bristol-Myers Squibb Company for years. Cogentin C Lexapro C Multivitamin C Neurontin C 22-Feb-2006 08:31 AM Page: 901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Remeron C Date:08/30/05ISR Number: 4755571-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12975769 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Klonopin C Date:08/30/05ISR Number: 4755572-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12975991 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Acute Abilify PS Otsuka Hospitalization - Respiratory Failure Pharmaceutical Initial or Prolonged Company, Ltd. Metformin Hcl Xr Tabs 500 Mg C Lipitor C Nexium C Coumadin C Bristol-Myers Squibb Company on Sunday, Tuesday, Thursday, and Saturday Coumadin C Bristol-Myers Squibb Company on Monday, Wednesday, and Friday Meclizine Hcl C Date:08/30/05ISR Number: 4755573-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12976247 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 3 MON Prozac C ORAL 3 MON Date:08/30/05ISR Number: 4755574-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12976916 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs PS Otsuka Somnolence Pharmaceutical Weight Decreased Company, Ltd. ORAL Levoxyl C 22-Feb-2006 08:31 AM Page: 902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755575-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12977021 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swollen Tongue Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755576-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12977393 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Abilify PS Otsuka Nausea Pharmaceutical Suicidal Ideation Company, Ltd. 1 MON Celexa C Date:08/30/05ISR Number: 4755577-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12978300 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swollen Tongue Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755578-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12978318 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphasia Abilify PS Otsuka Swollen Tongue Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755579-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12978367 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Treatment Noncompliance Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755580-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12978516 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Ritalin C Date:08/30/05ISR Number: 4755581-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12978854 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Aripiprazole PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:08/30/05ISR Number: 4755582-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12978862 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 15 Mg PS Otsuka Coordination Abnormal Pharmaceutical Muscle Rigidity Company, Ltd. Estropipate C Zelnorm C Zoloft C Protonix C Levothyroxine C Norvasc C Date:08/30/05ISR Number: 4755583-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12979092 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Incorrect Dose Pharmaceutical Other Administered Company, Ltd. Date:08/30/05ISR Number: 4755584-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12979423 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 WK Ativan C Date:08/30/05ISR Number: 4755585-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12979720 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Palpitations Abilify PS Otsuka Sleep Disorder Pharmaceutical Company, Ltd. Adderall C Date:08/30/05ISR Number: 4755586-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12979894 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755587-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12979902 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:08/30/05ISR Number: 4755588-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12980421 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify Tabs PS Otsuka Cold Sweat Pharmaceutical Fatigue Company, Ltd. ORAL Insomnia Palpitations Salivary Hypersecretion Date:08/30/05ISR Number: 4755589-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12980512 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify Tabs PS Otsuka Decreased Appetite Pharmaceutical Eye Pain Company, Ltd. 10 mg then Hypotension decreased to Somnolence 7.5 mg Propanol C Lovastatin C Isosorbide C Plavix C Regulatory Health Authority South Africa Asa C Reminyl C Betoptic Drops C Date:08/30/05ISR Number: 4755590-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12981114 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 5 Mg PS Otsuka Anxiety Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755591-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12981726 Age:9 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755592-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12981734 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depersonalisation Abilify PS Otsuka Dizziness Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755593-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12982096 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Oesophageal Abilify PS Otsuka Dysphagia Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755594-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12982450 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Abilify PS Otsuka Somnolence Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755595-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12982880 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify PS Otsuka Delirium Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755596-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12982922 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restless Legs Syndrome Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755597-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12982930 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Tic Pharmaceutical Company, Ltd. 1 YR Date:08/30/05ISR Number: 4755598-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12982948 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755599-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12984076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Stomatitis Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755600-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12984092 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Initially started on 2.5 mg. Dose was increased to 5 mg. Date:08/30/05ISR Number: 4755601-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12984183 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Psychomotor Hyperactivity Pharmaceutical Weight Decreased Company, Ltd. Depakote C Synthroid C Date:08/30/05ISR Number: 4755602-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12984332 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Abilify PS Otsuka Initial or Prolonged Drug Interaction Pharmaceutical Intentional Misuse Company, Ltd. Irritability Cytomel SS Lethargy Klonopin SS Suicidal Ideation Lexapro SS Lexapro SS Lexapro SS Strattera C Date:08/30/05ISR Number: 4755603-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12984738 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755604-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12985255 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755605-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12985701 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 WK Seroquel C Depakote C Date:08/30/05ISR Number: 4755606-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12985891 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Weight Decreased Pharmaceutical Company, Ltd. 5 YR Abilify SS Otsuka Pharmaceutical Company, Ltd. 5 YR Lexapro C Topamax C Date:08/30/05ISR Number: 4755607-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12986121 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755608-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12987251 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755609-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12987269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755610-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12987277 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755611-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12989349 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Paxil C Lexapro C Estrogen Patch C Nexium C Thyroid C Date:08/30/05ISR Number: 4755612-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12990073 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Abilify Tabs PS Otsuka Faecaloma Pharmaceutical Company, Ltd. One-5 mg tablet every other day alternating with Date:08/30/05ISR Number: 4755613-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12990461 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mydriasis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755614-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12991196 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Migraine Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755615-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12992368 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755616-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12992467 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755617-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12992756 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Incorrect Dose Abilify PS Otsuka Administered Pharmaceutical Somnolence Company, Ltd. Date:08/30/05ISR Number: 4755618-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993028 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Hypoaesthesia Pharmaceutical Insomnia Company, Ltd. Paraesthesia Seroquel C Eventually lowered to 25 mg. Lithium C Date:08/30/05ISR Number: 4755619-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993051 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Blood Glucose Increased Pharmaceutical Disorientation Company, Ltd. 5 mg, Drug Ineffective 01-Jun-05, Dysarthria incr (dose Dysgraphia not Dysphagia specified) on Fatigue Lithium C Hiccups Clonidine C Impaired Driving Ability Zocor C Nausea Femara C Parkinsonian Gait Promethazine C Sedation Tremor Date:08/30/05ISR Number: 4755620-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993077 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Convulsion Pharmaceutical Other Company, Ltd. 2 YR Lexapro C Date:08/30/05ISR Number: 4755621-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993366 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Spontaneous Penile Abilify PS Otsuka Erection Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755622-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993853 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Abilify Tabs PS Otsuka Malaise Pharmaceutical Nausea Company, Ltd. Hyzaar C Sular C Date:08/30/05ISR Number: 4755623-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12993960 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Abilify Tabs PS Otsuka Decreased Pharmaceutical Company, Ltd. Lamictal C Date:08/30/05ISR Number: 4755624-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12995049 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Parkinsonian Gait Pharmaceutical Company, Ltd. Prolixin Decanoate C Date:08/30/05ISR Number: 4755625-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12995064 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify PS Otsuka Pharmaceutical Company, Ltd. Zyprexa C Date:08/30/05ISR Number: 4755626-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12996286 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755627-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12996609 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Abilify Tabs 10 Mg PS Otsuka Decreased Pharmaceutical Company, Ltd. ORAL Zoloft C 22-Feb-2006 08:31 AM Page: 911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755628-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12996823 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tongue Disorder Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL January 2004 10mg, 20mg October 2004, April 2005 10mg Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL January 2004 10mg, 20mg October 2004, April 2005 10mg Luvox C Methylphenidate C Date:08/30/05ISR Number: 4755629-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12997284 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755630-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12997565 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify Tabs PS Otsuka Phosphokinase Increased Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755631-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12997672 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Abilify Tabs PS Otsuka Initial or Prolonged Therapeutic Response Pharmaceutical Other Decreased Company, Ltd. Varying doses from 15 mg/day to 30 mg/day 3 YR Prozac C Topamax C 1 WK Date:08/30/05ISR Number: 4755633-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12997797 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755634-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12998563 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Abilify Tabs PS Otsuka Paranoia Pharmaceutical Company, Ltd. ORAL 6 YR Insulin C Lantus C Prandin C Precose C Actos C Depakote C Date:08/30/05ISR Number: 4755635-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12998829 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Abilify PS Otsuka Pharmaceutical Company, Ltd. Benadryl C Date:08/30/05ISR Number: 4755636-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12998928 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Abilify Tabs PS Otsuka Initial or Prolonged Dysarthria Pharmaceutical Gait Disturbance Company, Ltd. Hallucination Seroquel C Hypotonia Musculoskeletal Stiffness Date:08/30/05ISR Number: 4755637-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12999512 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphonia Abilify PS Otsuka Pharyngolaryngeal Pain Pharmaceutical Company, Ltd. 3 MON Buspar SS Bristol-Myers Squibb Company 3 MON Date:08/30/05ISR Number: 4755638-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12999603 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755639-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12999827 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pyrexia Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755640-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12999843 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755641-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000153 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755642-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000815 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Abilify Tabs PS Otsuka Initial or Prolonged Pyrexia Pharmaceutical Other Company, Ltd. 1 YR Date:08/30/05ISR Number: 4755643-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000823 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Dilaudid C Accupril C Date:08/30/05ISR Number: 4755644-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13000930 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Abilify Tabs PS Otsuka Medication Error Pharmaceutical Photopsia Company, Ltd. Vision Blurred Lexapro C 22-Feb-2006 08:31 AM Page: 914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755645-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13001565 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Increased Pharmaceutical Other Heart Rate Increased Company, Ltd. Lexapro C Seroquel C Date:08/30/05ISR Number: 4755647-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13002050 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify Tabs 5 Mg PS Otsuka Fatigue Pharmaceutical Myalgia Company, Ltd. Somnolence Estradiol C Apothecon Calcium C Vitamins C Date:08/30/05ISR Number: 4755648-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13003082 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755649-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13003140 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Somnolence Pharmaceutical Suicide Attempt Company, Ltd. ORAL 24 HR Levothyroxine SS Risperdal SS Lithium SS Sertraline SS Date:08/30/05ISR Number: 4755650-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13004528 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Abilify PS Otsuka Inversion Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755651-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13004619 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage: increased to 22-Feb-2006 08:31 AM Page: 915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 15mg at bedtime in January 2004 Topamax C Lexapro C Claritin C Trazodone Hcl Tabs C Apothecon Date:08/30/05ISR Number: 4755652-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13004965 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Generalised Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 2 DAY Date:08/30/05ISR Number: 4755653-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13005475 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755654-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13005939 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Tremor Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755655-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006408 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Geodon C Dose Value: 160 at night Date:08/30/05ISR Number: 4755656-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006549 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755657-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006713 Age: Gender: I/FU:I Outcome PT Body Temperature Fluctuation 22-Feb-2006 08:31 AM Page: 916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Cold Feeling Hot Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755658-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13007596 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. Cymbalta C Lamictal C Date:08/30/05ISR Number: 4755659-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13007950 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuropathy Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755660-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13008008 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Klonopin C Luvox C Depakote C Date:08/30/05ISR Number: 4755661-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13008115 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755662-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13008941 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Hallucination, Auditory Pharmaceutical Prescribed Overdose Company, Ltd. Dose lowered to 45 mg/day 22-Feb-2006 08:31 AM Page: 917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755663-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13009238 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 2 MON Klonopin C Lithium C Date:08/30/05ISR Number: 4755664-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13009378 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertrophy Breast Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755665-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13009394 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755666-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13011796 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antidepressant Drug Level Abilify PS Otsuka Increased Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755667-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13011820 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Disorder Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755668-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13011838 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755669-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13012489 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 10 Mg PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL Date:08/30/05ISR Number: 4755670-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13012752 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Abilify Tabs 20 Mg PS Otsuka Hypersomnia Pharmaceutical Vision Blurred Company, Ltd. ORAL Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Klonopin C Date:08/30/05ISR Number: 4755671-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13012760 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. ORAL Lorazepam C Temazepam C Neurontin C Sermion C Lovastatin C Novolog C Date:08/30/05ISR Number: 4755672-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13014907 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs 5 Mg PS Otsuka Muscle Tightness Pharmaceutical Restlessness Company, Ltd. ORAL Duration: 4 Tremor to 6 weeks 5 WK Insulin C Atenolol C Sandoz Inc. (Geneva Pharm Tech) Atacand C Tricor C Niacin C Neurontin C Zoloft C Aspirin C Zantac C Date:08/30/05ISR Number: 4755673-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13015136 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Pharmaceutical Company, Ltd. Clonidine C 22-Feb-2006 08:31 AM Page: 919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vistaril C Date:08/30/05ISR Number: 4755674-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13015771 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. Lamictal C Cymbalta C Date:08/30/05ISR Number: 4755675-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13016332 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs 20 Mg PS Otsuka Insomnia Pharmaceutical Logorrhoea Company, Ltd. ORAL An additional 10mg daily was added on 24-Jun-2005 to her 20mg Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL An additional 10mg daily was added on 24-Jun-2005 to her 20mg Abilify Tabs 20 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL An additional 10mg daily was added on 24-Jun-2005 to her 20mg Ambien SS 6 MON Geodon C Trileptal C Date:08/30/05ISR Number: 4755676-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13016381 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Somnolence Pharmaceutical Vomiting Company, Ltd. ORAL 1 WK Lexapro C Depakote C Risperdal C 22-Feb-2006 08:31 AM Page: 920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755677-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13016803 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755678-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13016886 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755679-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13018130 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify PS Otsuka Drug Interaction Pharmaceutical Company, Ltd. Risperdal C Prozac I Date:08/30/05ISR Number: 4755680-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13019880 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 5 Mg PS Otsuka Vomiting Pharmaceutical Company, Ltd. ORAL Prilosec C Thyroid C Date:08/30/05ISR Number: 4755681-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13021613 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Abilify Tabs PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. Seroquel C Ritalin C Clonidine C Date:08/30/05ISR Number: 4755682-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13021654 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin Xl C Date:08/30/05ISR Number: 4755683-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13021761 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755684-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13022041 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hunger Abilify PS Otsuka Vomiting Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755685-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13022090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Abilify PS Otsuka Depression Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755686-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13022462 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755687-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13022520 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755688-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13023031 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Eye Abilify PS Otsuka Vision Blurred Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755689-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13024807 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755690-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13026729 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. 2 WK Date:08/30/05ISR Number: 4755691-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13027719 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Metrorrhagia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage increased to 5mg daily on 05-Jul-2005 1 MON Allegra C Singulair C Date:08/30/05ISR Number: 4755692-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028188 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs PS Otsuka Somnolence Pharmaceutical Tremor Company, Ltd. ORAL 1 YR Date:08/30/05ISR Number: 4755693-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028550 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs PS Otsuka Swollen Tongue Pharmaceutical Company, Ltd. Lithium C Seroquel C Lamictal C Date:08/30/05ISR Number: 4755694-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028618 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Strabismus Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755695-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028824 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755696-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028840 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755697-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028873 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 MON Date:08/30/05ISR Number: 4755698-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13028899 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ejaculation Delayed Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755699-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13030358 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755700-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13030523 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. 1 YR Lamictal C Trazodone Hcl C Apothecon Wellbutrin Sr C Lexapro C Ambien C 22-Feb-2006 08:31 AM Page: 924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755702-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13031323 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorgasmia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755703-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13031653 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755704-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13031687 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 5 Mg PS Otsuka Muscular Weakness Pharmaceutical Company, Ltd. ORAL Dose = "one to two tablets daily" Depo-Provera C Effexor C 8 YR Trazodone Hcl C Apothecon Date:08/30/05ISR Number: 4755705-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13032073 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Status Changes Abilify Tabs PS Otsuka Speech Disorder Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755706-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13032347 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755707-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13032404 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gynaecomastia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755708-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13032628 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Elavil C Strattera C Date:08/30/05ISR Number: 4755709-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13032834 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755710-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13032867 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755711-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033097 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Drug Interaction Pharmaceutical Company, Ltd. Depakote I Topamax I Date:08/30/05ISR Number: 4755712-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033121 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755713-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033139 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify Tabs PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. 3 YR Lexapro C 8 MON Ativan C Glucophage C Bristol-Myers Squibb Company Glipizide C 1 YR 22-Feb-2006 08:31 AM Page: 926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755714-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033451 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755715-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033485 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceutical Other Company, Ltd. Date:08/30/05ISR Number: 4755716-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033519 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755717-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033584 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755718-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13033915 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Trazodone Hcl Tabs C Apothecon Prozac C Ativan C Effexor C Risperdal C 2+ YEARS 2 YR Zyprexa C > 6 YEARS 6 YR Eskalith C 450 MG- 2 Date:08/30/05ISR Number: 4755719-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13035241 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Syncope Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Solian C 22-Feb-2006 08:31 AM Page: 927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755720-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13035290 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Syncope Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Risperdal C Date:08/30/05ISR Number: 4755721-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13036181 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothyroidism Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. 2 YR Lexapro C Ritalin C Date:08/30/05ISR Number: 4755722-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13036686 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755723-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13036868 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Lisinopril C Dose value: 1 tablet in the a.m., and 2 tablets in the p.m. Norvasc C Metoprolol Tartrate C Apothecon Tegretol C Klonopin C Date:08/30/05ISR Number: 4755724-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13037510 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Trilafon C 22-Feb-2006 08:31 AM Page: 928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755725-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13038153 Age:51 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoglycaemia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Prozac C Date:08/30/05ISR Number: 4755726-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13038260 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agoraphobia Abilify Tabs PS Otsuka Blood Glucose Increased Pharmaceutical Fatigue Company, Ltd. Suspiciousness Metformin Hcl SS Bristol-Myers Squibb Company Wellbutrin C Trazodone Hcl C Apothecon Avandia C Date:08/30/05ISR Number: 4755727-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13038344 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755728-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13038377 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755729-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13038559 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755730-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13038633 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Abilify Tabs PS Otsuka Initial or Prolonged Hypertension Pharmaceutical Somnolence Company, Ltd. 22-Feb-2006 08:31 AM Page: 929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755731-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13038682 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Duration of therapy: couple of months Date:08/30/05ISR Number: 4755732-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13039185 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Abilify Tabs 5 Mg PS Otsuka Syndrome Pharmaceutical Company, Ltd. ORAL 3 DAY Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Zoloft C Date:08/30/05ISR Number: 4755733-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13039227 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Concerta C Ritalin C Date:08/30/05ISR Number: 4755734-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13040357 Age:3 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Abilify Tabs PS Otsuka Nausea Pharmaceutical Pyrexia Company, Ltd. Vomiting Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. Abilify Tabs SS Otsuka Pharmaceutical Company, Ltd. Zoloft C Date:08/30/05ISR Number: 4755735-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13040605 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755736-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13040712 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify PS Otsuka Pharmaceutical Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. Zoloft C Date:08/30/05ISR Number: 4755737-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13041009 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Pharmaceutical Company, Ltd. Concerta C Date:08/30/05ISR Number: 4755738-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13042056 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceutical Company, Ltd. Cholesterol Medication C Date:08/30/05ISR Number: 4755739-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13042163 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755740-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13042593 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. Benadryl C Date:08/30/05ISR Number: 4755741-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13042619 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Nausea Pharmaceutical Vomiting Company, Ltd. 22-Feb-2006 08:31 AM Page: 931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755742-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13042668 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceutical Company, Ltd. Ambien C Naproxen C Date:08/30/05ISR Number: 4755743-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13042981 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755744-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13043013 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro SS ORAL Dosage: increased to 20mg daily on 03-Jan-2005 Prozac SS ORAL Dosage: 20mg daily 07-Feb-2005 to unknown, 40mg daily Depakote C Lisinopril C Diovan C Coreg C Wellbutrin C Dosage: Decreased to 200mg daily on 11-Apr-2005 Hydrocodone + Acetaminophen C Date:08/30/05ISR Number: 4755745-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13043179 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Zoloft C Lithobid C Lescol C Multivitamin C Calcium C 22-Feb-2006 08:31 AM Page: 932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755746-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13043476 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Clozaril C Date:08/30/05ISR Number: 4755747-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13043500 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755748-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13044409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Ambien C Doxepin C Fluoxetine C Neurontin C Date:08/30/05ISR Number: 4755749-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13045034 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Nausea Pharmaceutical Vomiting Company, Ltd. Date:08/30/05ISR Number: 4755750-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13045083 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755751-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13045166 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Ulcer Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755752-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13045349 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Papular Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755753-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13045828 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Abilify Tabs PS Otsuka Initial or Prolonged Pyrexia Pharmaceutical Company, Ltd. Lithium C Date:08/30/05ISR Number: 4755754-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046388 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ejaculation Delayed Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755755-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046743 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755756-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046800 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755757-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046891 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755758-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046917 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755759-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046925 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755760-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046933 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755762-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046941 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755763-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046958 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755764-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13046966 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755765-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047089 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Abilify PS Otsuka Increased Pharmaceutical Blood Triglycerides Company, Ltd. Increased 22-Feb-2006 08:31 AM Page: 935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755766-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047790 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 WK Date:08/30/05ISR Number: 4755767-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047923 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755768-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047949 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755769-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047980 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Insulin C Lithium C Klonopin C Date:08/30/05ISR Number: 4755770-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13048160 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Abilify PS Otsuka Medication Error Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755771-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13048319 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify PS Otsuka Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755772-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13048723 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify Tabs 5 Mg PS Otsuka Swelling Face Pharmaceutical Company, Ltd. ORAL 7 MON Abilify Tabs 5 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 7 MON Ambien C Tobramycin C Date:08/30/05ISR Number: 4755773-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13049606 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755774-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13051321 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Syphilis Test Positive Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755775-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13051529 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755776-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13051537 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755777-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13052451 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Weight Increased Pharmaceutical Company, Ltd. ORAL 3 YR 22-Feb-2006 08:31 AM Page: 937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755778-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13052691 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755779-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13052808 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceutical Company, Ltd. Seroquel C Date:08/30/05ISR Number: 4755780-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13052832 Age:6 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755781-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13052899 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755782-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13053319 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify PS Otsuka Pain In Extremity Pharmaceutical Company, Ltd. 1 MON Lithium C Date:08/30/05ISR Number: 4755783-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13053459 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755784-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13053715 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify Tabs PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:08/30/05ISR Number: 4755785-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13053723 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs 10 Mg PS Otsuka Hypertrophy Breast Pharmaceutical Insomnia Company, Ltd. ORAL 2 MON Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Lipitor C Metformin Hcl C Bristol-Myers Squibb Company Baby Aspirin C Date:08/30/05ISR Number: 4755786-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13054663 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Lisinopril C Toprol C Insulin C Nexium C Klonopin C Seroquel C Date:08/30/05ISR Number: 4755787-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13054689 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755788-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13054713 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Methylphenidate Hcl C Date:08/30/05ISR Number: 4755789-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13054960 Age: Gender:Female I/FU:I Outcome PT Bronchitis Mood Swings Oedema Psychotic Disorder Stress 22-Feb-2006 08:31 AM Page: 939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 YR Date:08/30/05ISR Number: 4755790-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13056031 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755791-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13056536 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceutical Company, Ltd. Clozaril C Date:08/30/05ISR Number: 4755792-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13056569 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Tardive Dyskinesia Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755793-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13056791 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755794-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13056809 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify PS Otsuka Haemorrhage Subcutaneous Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755795-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13056866 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Halo Vision Abilify Tabs PS Otsuka Visual Disturbance Pharmaceutical Company, Ltd. 22-Feb-2006 08:31 AM Page: 940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755796-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13058144 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swollen Tongue Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755797-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13058474 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify Tabs 5 Mg PS Otsuka Trismus Pharmaceutical Company, Ltd. ORAL Slo-Mag C Quinine I Cinchona Bark I Citalopram Hydrobromide I Date:08/30/05ISR Number: 4755798-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13059209 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Abilify PS Otsuka Pain In Extremity Pharmaceutical Company, Ltd. Prozac C Synthroid C Neurontin C Depakote C Dose value: 500 mg in the morning and 1000 mg in the evening. Date:08/30/05ISR Number: 4755799-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13064852 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4755800-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13064860 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4755801-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13065909 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Syphilis Test Positive Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4755802-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13069109 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:08/30/05ISR Number: 4756475-1Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0565569A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affect Lability Wellbutrin Xl PS Glaxosmithkline ORAL 300MG Per day 3 DAY Anxiety Abilify SS UNKNOWN Dysarthria Topamax C Dysphemia Nausea Date:08/30/05ISR Number: 4756704-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13088638 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Excitability Pharmaceutical Company, Ltd. ORAL Date:08/30/05ISR Number: 4756744-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13083969 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Malaise Pharmaceutical Company, Ltd. ORAL Alcohol SS Lexomil C ORAL Seresta C ORAL Nozinan C ORAL Laroxyl C Deroxat C ORAL Mepronizine C ORAL Date:08/31/05ISR Number: 4757142-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13082649 Age:28 YR Gender:Female I/FU:I Outcome PT Other Abortion Drug Exposure During Pregnancy Foetal Growth Retardation 22-Feb-2006 08:31 AM Page: 942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Twin Pregnancy Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:08/31/05ISR Number: 4757169-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13007927 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Abilify Tabs 15 Mg PS Otsuka Eczema Pharmaceutical Mental Impairment Company, Ltd. ORAL Rash Pruritic Gabapentin C ORAL Therapy from: Skin Disorder pre-2000 Skin Haemorrhage Clopixol C INTRAMUSCULAR Therapy from: Pre-2000, dose 200 mg every 2-3 weeks Procyclidine C ORAL Therapy from: Pre-2000 Date:08/31/05ISR Number: 4757307-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13087267 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/31/05ISR Number: 4757309-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13087259 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/31/05ISR Number: 4757310-8Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13092127 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:08/31/05ISR Number: 4757440-0Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-13090881 Age:17 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Disability 22-Feb-2006 08:31 AM Page: 943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Areflexia Abilify Tabs 10 Mg PS Otsuka Coma Pharmaceutical Drug Interaction Company, Ltd. ORAL Epilepsy Zyprexa I ORAL 25 DAY Medication Error Date:08/31/05ISR Number: 4757599-5Report Type:Expedited (15-DaCompany Report #2005PK01130 Age:8028 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 100 MG TO 800 MG 29 DAY Risperdal SS ORAL 2 MG TO 4 MG 10 DAY Solian SS ORAL 100 MG TO 400 MG 44 DAY Abilify SS ORAL Date:08/31/05ISR Number: 4757771-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13090014 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Aripiprazole PS Otsuka Abnormal Pharmaceutical Ventricular Company, Ltd. Pre-Excitation Clozaril SS ORAL 3 YR Wolff-Parkinson-White Haloperidol C UNKNOWN Syndrome Procyclidine C UNKNOWN Date:08/31/05ISR Number: 4757773-8Report Type:Expedited (15-DaCompany Report #HU-BRISTOL-MYERS SQUIBB COMPANY-12938809 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prescribed Overdose Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Other Company, Ltd. ORAL Clonazepam C Procyclidine C Date:08/31/05ISR Number: 4758739-4Report Type:Direct Company Report #CTU 257431 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Enuresis Abilify 2.5 Mg PS ORAL 2.5 MG PO AM Sedation Date:09/01/05ISR Number: 4761314-9Report Type:Direct Company Report #CTU 257468 Age:47 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Required Intervention to PT Report Source Product Role Manufacturer Route Dose Duration Prevent Permanent Diabetes Mellitus Abilify 15mg PS Impairment/Damage Diabetic Hyperosmolar Premarin C Coma Flagyl C Dialysis Pancreatitis Polydipsia Polyuria Renal Failure Acute Date:09/06/05ISR Number: 4761602-6Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13092564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:09/06/05ISR Number: 4761764-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13075668 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Abilify Tabs PS Otsuka Rash Pustular Pharmaceutical Company, Ltd. ORAL 127 DAY Atarax SS ORAL Lepticur SS ORAL 3 DAY Date:09/06/05ISR Number: 4761890-6Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13095526 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Abilify Tabs 15 Mg PS Otsuka Contusion Pharmaceutical Skin Discolouration Company, Ltd. ORAL Tricyclic Antidepressants C Date:09/06/05ISR Number: 4761892-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13093042 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Insipidus Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Ativan C Coumadin C Bristol-Myers Squibb Company Depakote C Pepcid C Hydroxyzine C Lexapro C Proamatine C Risperdal C Timoptic C 22-Feb-2006 08:31 AM Page: 945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/05ISR Number: 4764497-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13095534 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. 2 YR Date:09/09/05ISR Number: 4765006-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12956777 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 15 Mg PS Otsuka Respiratory Arrest Pharmaceutical Self-Medication Company, Ltd. ORAL Dosage: 15mg initiated on 20-Apr-2005 Ventolin C Lepticur C Lysanxia C Laroxyl C ORAL Date:09/12/05ISR Number: 4765702-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13078951 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:09/12/05ISR Number: 4765718-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13060462 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 WK Simvastatin C Atenolol C Sandoz Inc. (Geneva Pharm Tech) Furosemide C L-Thyroxine C Lisinopril C Aspirin C Spironolactone C Lithium C Valproic Acid C Date:09/12/05ISR Number: 4766169-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13087259 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage: initiated at 10 mg daily during 22-Feb-2006 08:31 AM Page: 946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report hospitalizati Citalopram Hydrobromide C Risperidone C Date:09/12/05ISR Number: 4766424-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13097969 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Exophthalmos Abilify Tabs PS Otsuka Initial or Prolonged Mood Swings Pharmaceutical Nervousness Company, Ltd. ORAL 3 MON Weight Decreased Zoloft SS ORAL Date:09/13/05ISR Number: 4767148-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12987459 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Abilify PS Otsuka Drug Exposure During Pharmaceutical Pregnancy Company, Ltd. Ectopic Pregnancy Intra-Uterine Death Pregnancy Date:09/13/05ISR Number: 4767690-5Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13099320 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Blood Pressure Abnormal Pharmaceutical Dysstasia Company, Ltd. ORAL 2 MON Feeling Hot Chlordiazepoxide C Headache Malaise Date:09/13/05ISR Number: 4767691-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13098215 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro C ORAL Lotensin C ORAL Premarin C ORAL Prevacid C ORAL Crestor C ORAL Ativan C ORAL Norvasc C DAY Wellbutrin Sr C 22-Feb-2006 08:31 AM Page: 947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/05ISR Number: 4767718-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13096680 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Abilify PS Otsuka Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Depakote Er C ORAL 11 DAY Depakote Er C ORAL 11 DAY Ristoril C 10 DAY Date:09/14/05ISR Number: 4768766-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12756243 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:09/14/05ISR Number: 4768788-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13078217 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Insomnia Abilify Tabs 30 Mg PS Otsuka Hospitalization - Self Injurious Behaviour Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Dosage: initaited at 5 mg and then titrated up to 30 mg Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage: initaited at 5 mg and then titrated up to 30 mg Abilify Tabs 30 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage: initaited at 5 mg and then titrated up to 30 mg Navane C Lithium C 22-Feb-2006 08:31 AM Page: 948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/05ISR Number: 4770764-6Report Type:Direct Company Report #CTU 258165 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify 15 Mg PS ORAL 15 MG DAILY Oral Intake Reduced PO Trismus Risperdal 1 Mg SS ORAL 1 MG TWICE DAILY PO Lorazepam C Simvastatin C Benztropine C Sertraline C Date:09/14/05ISR Number: 4775302-XReport Type:Periodic Company Report #S05-USA-02568-01 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Health Lexapro Initial or Prolonged Blood Pressure Decreased Professional (Escitalopram) PS ORAL 10 MG QD PO Drug Interaction Lexapro Heart Rate Increased (Escitalopram) SS ORAL 30 MG QD PO Intentional Misuse Lexapro Irritability (Escitalopram) SS ORAL 2.5 MG QD PO Lethargy Lexapro Suicidal Ideation (Escitalopram) SS ORAL 5 MG QD PO Lexapro (Escitalopram) SS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 5 MG QD PO Lexapro (Escitalopram) SS ORAL 2.5 MG QD PO Cytomel (Liothyronine Sodium) SS Abilify (Aripiprazole) SS Klonopin (Clonazepam) SS Strattera (Atomoxetine) C Date:09/15/05ISR Number: 4770576-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050902205 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Consciousness Fluctuating Tramadol Delirium Hydrochloride PS ORAL Reminyl SS ORAL Madopar SS ORAL Madopar SS ORAL Abilify SS ORAL Mobic C ORAL Date:09/15/05ISR Number: 4770920-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13038393 Age:56 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Abilify PS Otsuka Hyponatraemia Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 3 DAY Gliclazide C Metaformin C Date:09/16/05ISR Number: 4771672-7Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12994562 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:09/19/05ISR Number: 4773060-6Report Type:Expedited (15-DaCompany Report #SI-BRISTOL-MYERS SQUIBB COMPANY-13110663 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Dependence Abilify Tabs 10 Mg PS Otsuka Other Loss Of Consciousness Pharmaceutical Company, Ltd. ORAL Heroin SS Seroquel C ORAL Seroxat C ORAL Date:09/19/05ISR Number: 4773068-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13103668 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify PS Otsuka Initial or Prolonged Illusion Pharmaceutical Insomnia Company, Ltd. ORAL Urbanyl C Forlax C Date:09/19/05ISR Number: 4773069-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13083969 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Haematoma Pharmaceutical Hepatomegaly Company, Ltd. ORAL Alcohol SS Lexomil C ORAL Seresta C ORAL Nozinan C ORAL Deroxat C ORAL Mepronizine C ORAL 22-Feb-2006 08:31 AM Page: 950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/05ISR Number: 4773122-3Report Type:Expedited (15-DaCompany Report #SI-BRISTOL-MYERS SQUIBB COMPANY-13110655 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Solian C ORAL Date:09/19/05ISR Number: 4775602-3Report Type:Direct Company Report #CTU 258409 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Abilify 15 Mg Intervention to Detoxification Bristol-Myers PS Bristol-Myers ORAL 15 MG ONCE A Prevent Permanent Drug Withdrawal Syndrome DAY PO 8 MON Impairment/Damage Economic Problem Feeling Abnormal Gambling Hallucination, Visual Hypersomnia Impaired Self-Care Insomnia Legal Problem Memory Impairment Obsessive-Compulsive Disorder Thinking Abnormal Date:09/20/05ISR Number: 4773391-XReport Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13032982 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somatoform Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 WK Date:09/20/05ISR Number: 4773749-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13106604 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Coronary Syndrome Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Cenestin C Ditropan C Lexapro C Lithium Carbonate C Os-Cal C Sinemet Cr Tabs 50mg/200mg C Bristol-Myers Squibb Company Amantadine C Synthroid C 22-Feb-2006 08:31 AM Page: 951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/05ISR Number: 4773752-9Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13106737 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. 6 WK Quetiapine C Topiramate C Benzodiazepines C Serotonin Reuptake Inhibitors C Date:09/20/05ISR Number: 4774021-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13107404 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. Date:09/21/05ISR Number: 4774390-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13103783 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Alcohol Withdrawal Pharmaceutical Syndrome Company, Ltd. ORAL Drug Interaction Acetaminophen C Hypertension Albuterol C Ipratropium C Lipitor C Lovenox C SUBCUTANEOUS Hydrocortisone C INTRAVENOUS Lisinopril C Lopressor C Vancomycin C INTRAVENOUS Halcion C ORAL Zosyn C INTRAVENOUS Protonix C INTRAVENOUS Remeron C Lorazepam C INTRAVENOUS Labetalol C INTRAVENOUS Fentanyl Citrate C TRANSDERMAL Docusate C Enteric Aspirin C Abilify Tabs 15 Mg I Otsuka Pharmaceutical Company, Ltd. ORAL Amiodarone I Date:09/21/05ISR Number: 4774632-5Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13109822 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Abilify Tabs 10 Mg PS Otsuka Social Phobia Pharmaceutical Company, Ltd. ORAL 4 WK Esertia C 22-Feb-2006 08:31 AM Page: 952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/05ISR Number: 4774633-7Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12991428 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Abilify Tabs 10 Mg PS Otsuka Extrasystoles Pharmaceutical Heart Rate Increased Company, Ltd. ORAL 12 DAY Mitral Valve Incompetence Piportil SS ORAL Stilnox C Vasten C Bristol-Myers Squibb Company Date:09/21/05ISR Number: 4774997-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13107438 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Abilify PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL Date:09/22/05ISR Number: 4776784-XReport Type:Direct Company Report #CTU 258674E Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Hypersensitivity Abilify 5 Mg Tablets Hospitalization - Pharyngeal Oedema Bristol-Myers-Squibb PS Bristol-Myers-Squibb ORAL 5 MG Q AM PO Initial or Prolonged Swollen Tongue Required Urticaria Generalised Intervention to Prevent Permanent Impairment/Damage Date:09/23/05ISR Number: 4776777-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13114582 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Aripiprazole PS Otsuka Initial or Prolonged Intentional Self-Injury Pharmaceutical Company, Ltd. ORAL Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel SS Date:09/23/05ISR Number: 4776778-4Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12937082 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Abilify PS Otsuka Initial or Prolonged Psychotic Disorder Pharmaceutical Suicidal Ideation Company, Ltd. ORAL Treatment Noncompliance 22-Feb-2006 08:31 AM Page: 953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/05ISR Number: 4776782-6Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13111695 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Loxapac C Loxapac C Date:09/23/05ISR Number: 4777541-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13109012 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Other Hepatic Steatosis Company, Ltd. 8 MON Muscle Spasms Citalopram C Metoprolol C Date:09/23/05ISR Number: 4777544-6Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13095575 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Accommodation Disorder Abilify PS Otsuka Other Diplopia Pharmaceutical Vision Blurred Company, Ltd. Abilify SS Otsuka Pharmaceutical Company, Ltd. 18 DAY Date:09/26/05ISR Number: 4777899-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112362 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Appendicectomy Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. Date:09/26/05ISR Number: 4777900-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13111174 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:09/26/05ISR Number: 4778109-2Report Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-13112677 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arterial Thrombosis Abilify PS Otsuka Blindness Pharmaceutical Company, Ltd. ORAL 20 MON Surmontil SS 16 DAY Surmontil SS 1 WK Methadone C 22-Feb-2006 08:31 AM Page: 954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxazepam C Date:09/26/05ISR Number: 4778737-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13087259 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dosage: initiated at 10 mg daily during hospitalizati Citalopram Hydrobromide C Risperidone C Date:09/26/05ISR Number: 4778741-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13113816 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Abilify Tabs PS Otsuka Tongue Disorder Pharmaceutical Company, Ltd. ORAL Mixtard C SUBCUTANEOUS 23 IU + 12 IU Carbamazepine C ORAL Dipyridamole C ORAL Aspirin C ORAL Perindopril C ORAL Senna C Date:09/27/05ISR Number: 4779713-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13087267 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Seropram C Date:09/28/05ISR Number: 4781182-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13097969 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Asthenia Pharmaceutical Exophthalmos Company, Ltd. ORAL 106 DAY Mood Swings Abilify Tabs 15 Mg SS Otsuka Nervousness Pharmaceutical Weight Decreased Company, Ltd. ORAL 106 DAY Zoloft SS ORAL Tercian C Artane C Lysanxia C 22-Feb-2006 08:31 AM Page: 955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/05ISR Number: 4781442-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13113956 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Abilify PS Otsuka Aggression Pharmaceutical Company, Ltd. ORAL Date:09/28/05ISR Number: 4784932-0Report Type:Expedited (15-DaCompany Report #US_0506118439 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Zyprexa Other Blood Triglycerides Health Increased Professional (Olanzapine) PS ORAL Chest Wall Pain Abilify Diabetes Mellitus (Aripiprazole) SS Non-Insulin-Dependent Humulin N (Insulin Glycosylated Haemoglobin Human Injection, Increased Isophane) C High Density Lipoprotein Fluvoxamine C Decreased Depakote (Valproate Low Density Lipoprotein Semisodium) C Increased Imipramine C Overdose Ranitidine C Weight Increased Acticin (Permethrin) C Metadate Cd (Methylphenidate Hydrochloride) C Oxybutynin C Albuterol C Ddavp (Desmopressin Acetate) C Luvox (Fluvoxamine Maleate) C Glucophage (Metformin) C Synthroid (Levothyroxine Sodium) C Levothyroxine C Hydroxyzine C Omeprazole C Metronidazole C Acetaminophen C Levoxyl (Levothyroxine Sodium) C Gemfibrozil C Metformin C Seroquel (Quetiapine Fumarate) C Humulin R (Insulin Human) C 22-Feb-2006 08:31 AM Page: 956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/05ISR Number: 4784996-4Report Type:Expedited (15-DaCompany Report #S05-USA-04044-01 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bulimia Nervosa Consumer Lexapro Depression (Escitalopram) PS ORAL 10 MG QD PO Restlessness Lexapro Weight Increased (Escitalopram) SS ORAL 20 MG QD PO Abilify (Aripiprazole) SS 20 MG QD Klonopin (Clonazepam) C Date:09/29/05ISR Number: 4783407-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12797676 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Abilify PS Otsuka Acute Psychosis Pharmaceutical Pregnancy Company, Ltd. Date:09/29/05ISR Number: 4783522-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13116702 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Abilify Tabs 20 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:09/30/05ISR Number: 4784196-8Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13092564 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:09/30/05ISR Number: 4784355-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12956777 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 15 Mg PS Otsuka Respiratory Arrest Pharmaceutical Self-Medication Company, Ltd. ORAL Dosage: 15mg initiated on 20-Apr-2005 Ventolin C Lepticur C Lysanxia C Laroxyl C ORAL Date:09/30/05ISR Number: 4784758-8Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13099320 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lacunar Infarction Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical 22-Feb-2006 08:31 AM Page: 957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. ORAL 2 MON Chlordiazepoxide C Adiro C Diamicron C Rivastigmine C Date:10/03/05ISR Number: 4786016-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12756243 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL Date:10/03/05ISR Number: 4786138-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082094 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Abilify PS Otsuka Initial or Prolonged Cerebrovascular Accident Pharmaceutical Other Chest Pain Company, Ltd. ORAL 4 WK Heart Rate Irregular Vasotec C Pollakiuria Cymbalta C Salivary Hypersecretion Vitamins C Thirst Cardizem C Transient Ischaemic Attack Visual Disturbance Date:10/04/05ISR Number: 4786889-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13119086 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Lamictal C Date:10/04/05ISR Number: 4787191-8Report Type:Expedited (15-DaCompany Report #TW-BRISTOL-MYERS SQUIBB COMPANY-13127121 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify Tabs PS Otsuka Initial or Prolonged Parkinsonism Pharmaceutical Urinary Retention Company, Ltd. ORAL Fluphenazine SS INTRAVENOUS 1 DAY Quetiapine C Trihexyphenidyl C ORAL Trazodone Hcl C Apothecon Lorazepam C ORAL Midazolam C ORAL Estazolam C ORAL 22-Feb-2006 08:31 AM Page: 958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/05ISR Number: 4787193-1Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13026117 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eczema Infected Abilify Tabs 15 Mg PS Otsuka Pruritus Pharmaceutical White Blood Cell Count Company, Ltd. ORAL Decreased Quilonum C Date:10/04/05ISR Number: 4787196-7Report Type:Expedited (15-DaCompany Report #RU-BRISTOL-MYERS SQUIBB COMPANY-12474540 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Aripiprazole PS Otsuka Initial or Prolonged Delusion Pharmaceutical Schizophrenia Company, Ltd. ORAL Date:10/04/05ISR Number: 4787266-3Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-13119755 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Oxazepam C Metformin Hcl C Bristol-Myers Squibb Company Date:10/05/05ISR Number: 4788443-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13121785 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Abilify Tabs PS Otsuka Inhalation Therapy Pharmaceutical Intestinal Obstruction Company, Ltd. ORAL 4 MON Vomiting Tercian C Risperdal C Date:10/06/05ISR Number: 4789686-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13122551 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Date:10/06/05ISR Number: 4789690-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13083969 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Epilepsy Pharmaceutical Other Company, Ltd. ORAL Alcohol SS Lexomil C ORAL Seresta C ORAL Nozinan C ORAL 22-Feb-2006 08:31 AM Page: 959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Deroxat C ORAL Mepronizine C ORAL Date:10/06/05ISR Number: 4797458-5Report Type:Direct Company Report #CTU 259909E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Aripiprazole PS 15MG Initial or Prolonged Blood Creatine Quetiapine C Phosphokinase Increased Carvedilol C Confusional State Gabapentin C Dyspnoea Lorazepam C Hypotension Furosemide C Neuroleptic Malignant Enalapril C Syndrome Ropinirole C Pyrexia Sepsis Tachycardia Troponin Increased Date:10/07/05ISR Number: 4791646-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13122619 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Abilify PS Otsuka Hospitalization - Lung Neoplasm Malignant Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Date:10/07/05ISR Number: 4791789-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13097258 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Abilify PS Otsuka Dizziness Pharmaceutical Fatigue Company, Ltd. ORAL Somnolence Fluoxetine C ORAL Duration of Stomach Discomfort therapy: 3 to 4 years Warfarin C Bristol-Myers Squibb Company ORAL 2 YR Propranolol C ORAL Duration of therapy: years Disopyramide C ORAL Lipitor C ORAL Co-Dydramol C Date:10/07/05ISR Number: 4791858-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13111695 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Culture Positive Abilify PS Otsuka Sepsis Pharmaceutical Staphylococcal Infection Company, Ltd. ORAL 13 DAY Loxapac C 4 DAY Loxapac C 4 DAY Laroxyl C 4 DAY 22-Feb-2006 08:31 AM Page: 960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/05ISR Number: 4791863-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13036678 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Facial Palsy Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Hypoacusis Pharmaceutical Company, Ltd. ORAL Lysanxia C Date:10/10/05ISR Number: 4792941-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13106604 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Coronary Syndrome Abilify Tabs 30 Mg PS Otsuka Arteriosclerosis Pharmaceutical Company, Ltd. ORAL Cenestin C Ditropan C Lexapro C Lithium Carbonate C Os-Cal C Sinemet Cr Tabs 50mg/200mg C Bristol-Myers Squibb Company Amantadine C Synthroid C Date:10/11/05ISR Number: 4793542-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13127436 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subileus Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Tercian C Depakine Chrono C Lysanxia C Imovane C Theralene C Atarax C Date:10/11/05ISR Number: 4794465-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13126750 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zyprexa C Zyprexa C 22-Feb-2006 08:31 AM Page: 961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/05ISR Number: 4794496-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13127428 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Tercian C Date:10/11/05ISR Number: 4794501-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13136296 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Topiramate SS Bupropion Sr SS Date:10/11/05ISR Number: 4794507-5Report Type:Expedited (15-DaCompany Report #SI-BRISTOL-MYERS SQUIBB COMPANY-13110655 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Solian C ORAL Date:10/11/05ISR Number: 4794522-1Report Type:Expedited (15-DaCompany Report #SK-BRISTOL-MYERS SQUIBB COMPANY-13074158 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Dosage: increased to 30 mg daily on 12-Aug-2005, Amisulpridum C Date:10/11/05ISR Number: 4794523-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13114582 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Aripiprazole PS Otsuka Initial or Prolonged Intentional Self-Injury Pharmaceutical Company, Ltd. ORAL Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel SS 22-Feb-2006 08:31 AM Page: 962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/05ISR Number: 4795098-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13114095 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify Tabs 15 Mg PS Otsuka Hyperhidrosis Pharmaceutical Rhabdomyolysis Company, Ltd. ORAL 15 DAY Loxapac I Date:10/12/05ISR Number: 4795718-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13138433 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Intentional Misuse Pharmaceutical Multiple Drug Overdose Company, Ltd. ORAL Amitriptyline SS Venlafaxine Hcl SS Date:10/14/05ISR Number: 4798428-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13115944 Age:4 DEC Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Fractures Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Suicide Attempt Pharmaceutical Company, Ltd. ORAL 2 MON Date:10/14/05ISR Number: 4798429-5Report Type:Expedited (15-DaCompany Report #CZ-BRISTOL-MYERS SQUIBB COMPANY-13133277 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Life-Threatening Convulsion Pharmaceutical Hospitalization - Company, Ltd. ORAL Initial or Prolonged Meclopin C Date:10/14/05ISR Number: 4798922-5Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13092564 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Family Stress Pharmaceutical Company, Ltd. ORAL Date:10/14/05ISR Number: 4804048-4Report Type:Expedited (15-DaCompany Report #2004032509 Age: Gender:Female I/FU:F Outcome PT Other Cheilitis Chest Pain Condition Aggravated Cough Diarrhoea Dizziness Drug Interaction Feeling Drunk Formication 22-Feb-2006 08:31 AM Page: 963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Hypothyroidism Nausea Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Disorder MG, 1 IN 1 Palpitations D), ORAL Panic Attack Geodon (Ziprasidone) SS 80 MG (80 MG, Paranoia 1 IN 1 D), Rash Dexamfetamine Restlessness (Dexamfetamine) SS Rhinorrhoea Abilify Serotonin Syndrome (Aripiprazole) SS Somnolence Risperdal Tunnel Vision (Risperidone) SS Vertigo Clonazepam Vomiting (Clonazepam) C Weight Increased Levoxyl (Levothyroxine Sodium) C Multivitamins (Multivitamins) C Vitamin C (Vitamin C) C Calcium (Calcium) C Vitamin B Complex (Calcium Pantothenate, Nicotinamide, Pyridoxine C Hydroxyzine (Hydroxyzine) C Benadryl C Date:10/17/05ISR Number: 4799870-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13096680 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Abilify PS Otsuka Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. 10 DAY Depakote Er C ORAL 11 DAY Depakote Er C ORAL 11 DAY Restoril C 10 DAY Date:10/17/05ISR Number: 4800289-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13083746 Age:45 YR Gender:Female I/FU:F Outcome PT Other Bulimia Nervosa Depression 22-Feb-2006 08:31 AM Page: 964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Appetite Restlessness Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Lexapro SS ORAL Dosage: increased to 20 mg dialy on 06-Aug-2005 Klonopin C Date:10/17/05ISR Number: 4800889-8Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13134986 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dizziness Abilify PS Otsuka Mental Impairment Pharmaceutical Company, Ltd. ORAL Trankimazin C Date:10/17/05ISR Number: 4800907-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13098215 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Abilify Tabs 10 Mg PS Otsuka Hospitalization - Hyperphagia Pharmaceutical Initial or Prolonged Polydipsia Company, Ltd. ORAL Polyuria Lexapro C ORAL Lotensin C ORAL Premarin C ORAL Prevacid C ORAL Crestor C ORAL Ativan C ORAL Norvasc C DAY Wellbutrin Sr C Baby Aspirin C Date:10/17/05ISR Number: 4804929-1Report Type:Expedited (15-DaCompany Report #B0395804A Age:18 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Wellbutrin Sr Completed Suicide Health Tablet-Controlled Professional Release (Bupropion Hydrochloride) PS Topiramate (Topiramate) SS ORAL ORAL Aripiprazole (Aripiprazole) SS 22-Feb-2006 08:31 AM Page: 965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/05ISR Number: 4802265-0Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13138706 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperventilation Abilify PS Otsuka Initial or Prolonged Insomnia Pharmaceutical Restlessness Company, Ltd. ORAL Tachycardia Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Zestril SS ORAL Metoprolol C Olanzapine C Date:10/18/05ISR Number: 4804026-5Report Type:Direct Company Report #CTU 260895 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Aripiprazole PS Tremor Date:10/19/05ISR Number: 4802875-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13139571 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. Date:10/19/05ISR Number: 4803511-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13107438 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Aripiprazole PS Otsuka Initial or Prolonged Schizophrenia Pharmaceutical Company, Ltd. ORAL Date:10/20/05ISR Number: 4804140-4Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13138052 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL increased from 15 mg daily to 20 mg daily on 15-Jul-2005 Risperdal SS ORAL Cymbalta SS ORAL Diazepam C ORAL Amitriptyline C ORAL 22-Feb-2006 08:31 AM Page: 966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4806159-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13138763 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Dosage: Increased to 30 mg daily. Increased to 45 mg daily 2 YR Clozaril C Geodon C Trileptal C Seroquel C Paxil C Date:10/21/05ISR Number: 4806210-3Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13092127 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Abilify PS Otsuka Hospitalization - Bradycardia Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Other Stelazine C ORAL Biperidene C ORAL Zoton C ORAL Lipitor C ORAL Metformin Hcl C Bristol-Myers Squibb Company ORAL Nu-Seals Aspirin C ORAL Emcor C ORAL Date:10/21/05ISR Number: 4806463-1Report Type:Expedited (15-DaCompany Report #2005UW15687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Disability Injury Pharmaceutical ORAL 22 MON Abilify SS 22 MON Risperdal SS 22 MON Date:10/21/05ISR Number: 4806484-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082094 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Abilify PS Otsuka Initial or Prolonged Cerebrovascular Accident Pharmaceutical Other Chest Pain Company, Ltd. ORAL 4 WK Heart Rate Irregular Vasotec C Pollakiuria Cymbalta C Salivary Hypersecretion Vitamins C Thirst Cardizem C Transient Ischaemic Glucosamine C Attack Aspirin C Visual Disturbance 22-Feb-2006 08:31 AM Page: 967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4806570-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13140405 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Arthroplasty Abilify Tabs 5 Mg PS Otsuka Hospitalization - Pulmonary Embolism Pharmaceutical Initial or Prolonged Company, Ltd. ORAL Namenda C Lotrel C Trazodone Hcl C Apothecon Ambien C Date:10/21/05ISR Number: 4807192-0Report Type:Direct Company Report #USP 57401 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Abilify 5 Mg Tab PS TAB Date:10/21/05ISR Number: 4808627-XReport Type:Direct Company Report #CTU 261151 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperkalaemia Abilify 30 Mg Bristol Myers Squibb PS Bristol Myers Squibb ORAL 30 MG DAILY PO Ipratropium C Sertraline C Loratadine C Benztropine C Aspirin C Lorazepam C Divalproex C Docusate C Finasteride C Omeprazole C Date:10/21/05ISR Number: 4809097-8Report Type:Direct Company Report #CTU 261124 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Abilify 10 Mg Bristol-Myers Squibb/Otsuka Pharma PS Bristol-Myers Squibb/Otsuka Pharma ORAL 1 QHS PO 5 MON Wellbutrin Xl C Lexapro C Date:10/24/05ISR Number: 4807609-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13003074 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL 13 MON Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL 13 MON Prozac C 22-Feb-2006 08:31 AM Page: 968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/05ISR Number: 4807700-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13144340 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 5 Mg PS Otsuka Fall Pharmaceutical Haematoma Company, Ltd. ORAL Skull Fracture Date:10/24/05ISR Number: 4809087-5Report Type:Direct Company Report #CTU 261227E Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Phosphorus Abilify 15mg PS ORAL 15MG QHS PO Hospitalization - Decreased Zoloft C Initial or Prolonged Depressed Level Of Required Consciousness Intervention to Diabetic Ketoacidosis Prevent Permanent Lethargy Impairment/Damage Malaise Pancreatitis Renal Failure Acute Sepsis Vomiting Date:10/24/05ISR Number: 4809124-8Report Type:Direct Company Report #CTU 261237 E Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Abilify PS 15 MG Q DAY Intervention to Economic Problem Prevent Permanent Insomnia Impairment/Damage Mania Restlessness Date:10/24/05ISR Number: 4809910-4Report Type:Direct Company Report #CTU 261258 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify Initial or Prolonged Convulsion Bristol-Myers PS Bristol-Myers ORAL 2.5MG ONCE Other Dystonia DAILY PO Date:10/25/05ISR Number: 4808298-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13145412 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 5 Mg PS Otsuka Fall Pharmaceutical Hypotension Company, Ltd. ORAL Date:10/25/05ISR Number: 4808308-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13144084 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs PS Otsuka Pharmaceutical 22-Feb-2006 08:31 AM Page: 969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company, Ltd. Date:10/25/05ISR Number: 4808470-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13144498 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 20 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 174 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 31 DAY Stilnox SS Atarax C Tareg C Date:10/25/05ISR Number: 4808471-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13134291 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Abilify PS Otsuka Drug Exposure During Pharmaceutical Pregnancy Company, Ltd. 10 WK Pregnancy Date:10/25/05ISR Number: 4808518-4Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13144407 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Aripiprazole PS Otsuka Initial or Prolonged Liver Function Test Pharmaceutical Abnormal Company, Ltd. ORAL Date:10/26/05ISR Number: 4810454-4Report Type:Expedited (15-DaCompany Report #KR-BRISTOL-MYERS SQUIBB COMPANY-13152327 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 98 DAY Date:10/26/05ISR Number: 4810573-2Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13109822 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Abilify Tabs 10 Mg PS Otsuka Social Phobia Pharmaceutical Company, Ltd. ORAL 4 WK Esertia C 22-Feb-2006 08:31 AM Page: 970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/05ISR Number: 4814681-1Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13149687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:10/28/05ISR Number: 4814686-0Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-13148432 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Life-Threatening Suicide Attempt Pharmaceutical Company, Ltd. ORAL Date:10/28/05ISR Number: 4815456-XReport Type:Direct Company Report #CTU 261706 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Abilify 20 Mg Initial or Prolonged Extraocular Muscle /Bristol-Myers Required Disorder Squibb PS Bristol-Myers Squibb ORAL 10 MG PO BID Intervention to Extrapyramidal Disorder Adderall C Prevent Permanent Faecal Incontinence Clonidine C Impairment/Damage Musculoskeletal Stiffness Seroquel C Torticollis Albuterol C Urinary Incontinence Date:10/31/05ISR Number: 4815582-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13113352 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Abilify Tabs PS Otsuka Atrial Fibrillation Pharmaceutical Electrocardiogram Qt Company, Ltd. ORAL Corrected Interval Zocor C Prolonged Toprol C Pain In Extremity Prinivil C Palpitations Hydrochlorothiazide C Glucophage C Bristol-Myers Squibb Company Glucotrol C Aspirin C Lexapro C Seroquel C Seroquel C Date:10/31/05ISR Number: 4815617-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13151527 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/05ISR Number: 4815758-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13150321 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Abilify Tabs 10 Mg PS Otsuka Chest Pain Pharmaceutical Mitral Valve Incompetence Company, Ltd. ORAL Date:10/31/05ISR Number: 4815759-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13105176 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Incontinence Pharmaceutical Neuroleptic Malignant Company, Ltd. ORAL 2 WK Syndrome Abilify Tabs 15 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Clonazepam C ORAL Lithium C ORAL Lithium C ORAL Ciprofloxacin C ORAL Citalopram C ORAL Date:10/31/05ISR Number: 4815925-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13111174 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 2 MON Wellbutrin Xl C Lamictal C Seroquel C Date:10/31/05ISR Number: 4816875-8Report Type:Direct Company Report #CTU 261827 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Amitriptyline PS 25 MG QID Initial or Prolonged Aripiprazole SS 12 MG QD Guaifenesin C Temazepam C Esgic C Buspirone C Simethicone- C Hyoscyamin C Date:11/01/05ISR Number: 4817070-9Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-13150776 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hemiparesis Pharmaceutical Company, Ltd. ORAL 2 WK 22-Feb-2006 08:31 AM Page: 972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/05ISR Number: 4817271-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13153523 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/01/05ISR Number: 4819003-8Report Type:Direct Company Report #CTU 261954 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Lamictal Initial or Prolonged Living Impaired Glaxo PS Glaxo Erythema Abilify Eye Discharge Otsuka Amr SS Otsuka Amr Fall Celexa C Mobility Decreased Calcium/Vit D C Otorrhoea Colace C Pruritus Cozaar C Purulence Zocor C Pyrexia Actonel C Rash Generalised Secretion Discharge Skin Lesion Date:11/02/05ISR Number: 4817712-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13027214 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Abilify Tabs 15 Mg PS Otsuka Other Increased Pharmaceutical Convulsion Company, Ltd. ORAL Diabetic Ketoacidosis Amisulpride C Glasgow Coma Scale Abnormal Hypotension Renal Failure Tachycardia Date:11/02/05ISR Number: 4817884-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13107404 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 DAY Risperidone C ORAL Bendroflumethiazide C Apothecon ORAL Amlodipine C ORAL Date:11/02/05ISR Number: 4817885-7Report Type:Expedited (15-DaCompany Report #AT-BRISTOL-MYERS SQUIBB COMPANY-13157227 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/05ISR Number: 4818027-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-13154570 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Risperidone SS Date:11/02/05ISR Number: 4818295-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13127428 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Drug Toxicity Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Seroplex C Tercian C Athymil C Noctran C Lexomil C Date:11/02/05ISR Number: 4818296-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13134291 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. 10 WK Date:11/02/05ISR Number: 4819060-9Report Type:Direct Company Report #CTU 262128 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Aripiprazole -Abilify- 10 Mg Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 10 MG DAILY PO Concerta C Diphenhydramine C Date:11/03/05ISR Number: 4819007-5Report Type:Expedited (15-DaCompany Report #SI-BRISTOL-MYERS SQUIBB COMPANY-13110655 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Psychotic Disorder Pharmaceutical Schizophrenia Company, Ltd. ORAL 07-Jun to Sedation 09-Jun-2005: 5mg/day; 10-Jun to 22-Feb-2006 08:31 AM Page: 974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 12-Jun-2005: Solian C ORAL Fluzepam C Ditamin C ORAL Date:11/03/05ISR Number: 4819009-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13154323 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Abilify PS Otsuka Initial or Prolonged Respiratory Distress Pharmaceutical Other Company, Ltd. ORAL 1 DAY Buspar Tabs SS Bristol-Myers Squibb Company ORAL 1 DAY Lamictal SS 1 DAY Zoloft SS ORAL 1 DAY Ambien C Klonopin C Date:11/03/05ISR Number: 4819615-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13159330 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Abilify PS Otsuka Electrocardiogram St Pharmaceutical Segment Elevation Company, Ltd. ORAL Date:11/04/05ISR Number: 4820263-8Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13156724 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biliary Colic Abilify PS Otsuka Liver Function Test Pharmaceutical Abnormal Company, Ltd. ORAL Date:11/04/05ISR Number: 4821088-XReport Type:Expedited (15-DaCompany Report #GB-MERCK-0510GBR00175 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zocor PS Merck & Co., Inc ORAL 215 DAY Initial or Prolonged Phosphokinase Increased Aripiprazole SS ORAL 204 DAY Coordination Abnormal Divalproex Sodium C ORAL Musculoskeletal Stiffness Zopiclone C ORAL Pain In Extremity Nifedipine C ORAL Aspirin C UNKNOWN Ferrous Sulfate C UNKNOWN Date:11/04/05ISR Number: 4822496-3Report Type:Expedited (15-DaCompany Report #DSA_27306_2005 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Temesta PS ORAL DF PO Initial or Prolonged Health Abilify SS ORAL 15 MG PO Professional Abilify SS ORAL 30 MG PO Other Abilify SS ORAL 15 MG PO Haldol "Janssen" C Lamictal 22-Feb-2006 08:31 AM Page: 975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report "Glaxosmithkline" C Lamictal "Glaxosmithkline" C Lamictal "Glaxosmithkline" C Lamictal "Glaxosmithkline" C Lamictal "Glaxosmithkline" C Date:11/04/05ISR Number: 4823014-6Report Type:Expedited (15-DaCompany Report #2005S1010330 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Study Aripiprazole (15 Mg) PS ORAL 15 MG;QD;PO Initial or Prolonged Mania Health Haloperidol Tablets, Professional Usp (5 Mg) SS ORAL 5 MG;QD;ORAL Other Date:11/07/05ISR Number: 4821984-3Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13015938 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Abilify PS Otsuka Initial or Prolonged Prescribed Overdose Pharmaceutical Company, Ltd. ORAL Increased to 45 mg/d on 31-Dec-04 and continuing. Seroquel SS ORAL Initiated at 400mg on 08-Oct-04/350 mg(13-18-Oct) /300mg(19-09- Date:11/08/05ISR Number: 4822604-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12918694 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Abilify Tabs 10 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Senna C Movelat C Lactulose C Perindopril C ORAL Aspirin C ORAL Simvastatin C ORAL Detrusitol C ORAL Beclomethasone C RESPIRATORY (INHALATION) Adizem C ORAL Salbutamol C RESPIRATORY (INHALATION) 22-Feb-2006 08:31 AM Page: 976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/05ISR Number: 4823364-3Report Type:Direct Company Report #CTU 262594 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Abilify 15 Mg Intervention to Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 15 MG ONCE Prevent Permanent DAILY PO Impairment/Damage Date:11/09/05ISR Number: 4824049-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13167325 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify PS Otsuka Initial or Prolonged Motor Dysfunction Pharmaceutical Other Restlessness Company, Ltd. 10 mg on 07-Oct-05; slow up-titration to 30 mg Ergenyl C Stilnox C Date:11/10/05ISR Number: 4824671-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13172077 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Abilify PS Otsuka Bipolar I Disorder Pharmaceutical Drug Ineffective Company, Ltd. ORAL Euphoric Mood Mood Altered Myalgia Trismus Date:11/10/05ISR Number: 4824684-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13163621 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Abilify Tabs PS Otsuka Initial or Prolonged Tremor Pharmaceutical Company, Ltd. Lithium C Xanax C Trazodone Hcl C Apothecon Nardil C Lithium C Date:11/11/05ISR Number: 4825702-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13004551 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg and then increased to 22-Feb-2006 08:31 AM Page: 977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 15 mg daily Date:11/11/05ISR Number: 4825736-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13004544 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Initiated at 10 mg/day Date:11/14/05ISR Number: 4827508-9Report Type:Expedited (15-DaCompany Report #KR-BRISTOL-MYERS SQUIBB COMPANY-13152327 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Ischaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Amisulpride C ORAL Vitamin B Complex C ORAL Diazepam C ORAL Haloperidol C ORAL Chlorpromazine C ORAL Date:11/14/05ISR Number: 4827530-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13107404 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Abilify Tabs 5 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 6 DAY Risperidone C ORAL Bendroflumethiazide C Apothecon ORAL Amlodipine C ORAL Acetylsalicylic Acid C ORAL Date:11/14/05ISR Number: 4827536-3Report Type:Expedited (15-DaCompany Report #KR-BRISTOL-MYERS SQUIBB COMPANY-13056403 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Abilify Tabs PS Otsuka Initial or Prolonged Increased Pharmaceutical Aspartate Company, Ltd. ORAL Dosage: 15mg Aminotransferase 03-Jun-2005, Increased increased to Erythema Multiforme 30mg 05-Jun-2005, Diazepam SS ORAL 5 WK Procyclidine SS ORAL Flunitrazepam SS ORAL 5 WK Chlorprothixene SS ORAL 22-Feb-2006 08:31 AM Page: 978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4827571-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13107438 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Aripiprazole PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Date:11/14/05ISR Number: 4827575-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13148705 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs PS Otsuka Initial or Prolonged Anxiety Pharmaceutical Other Condition Aggravated Company, Ltd. ORAL 4 MON Delusion Norset C Hallucination Temesta C Date:11/14/05ISR Number: 4827576-4Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13148697 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Abilify Tabs PS Otsuka Initial or Prolonged Delusion Pharmaceutical Other Hallucination Company, Ltd. ORAL 70 DAY Tercian C Effexor C Imovane C Date:11/14/05ISR Number: 4827585-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102786 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Event Risperdal PS 22 MON Death Abilify SS 22 MON Seroquel SS 22 MON Date:11/14/05ISR Number: 4827719-2Report Type:Expedited (15-DaCompany Report #CH-MERCK-0503USA05173 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Postural Prinzide PS Merck & Co., Inc ORAL 22 DAY Initial or Prolonged Prinivil SS ORAL 246 DAY Abilify SS ORAL 7 DAY Abilify SS ORAL 21 DAY Abilify SS ORAL 15 DAY Topiramate SS ORAL 3 DAY Topiramate SS ORAL 35 DAY Topiramate SS ORAL 4 DAY Topiramate SS ORAL 0 DAY Amlodipine Besylate SS ORAL Pantoprazole SS ORAL 184 DAY 22-Feb-2006 08:31 AM Page: 979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/05ISR Number: 4830069-1Report Type:Direct Company Report #CTU 263108E Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyskinesia Abilify 15 Mg Grand Mal Convulsion Bristol Myers Squibb PS Bristol Myers Squibb ORAL 15 MG PO Loss Of Consciousness DAILY( SEE Skin Discolouration IMAGE) Tremor Valproic Acid C Urinary Incontinence Advair C Diamox C Ativan C Topamax C Mvi C Date:11/15/05ISR Number: 4830548-7Report Type:Expedited (15-DaCompany Report #2004032509 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Cheilitis Health MG, 1 IN 1 Chest Pain Professional D); ORAL Condition Aggravated Geodon (Ziprasidone) SS 80 MG (80 MG, Cough 1 IN 1 D); Diarrhoea UNKNOWN Dizziness Dexamfetamine Drug Interaction (Dexamfetamine) SS Feeling Abnormal Abilify Feeling Drunk (Aripirazole) SS Formication Risperdale Hypertension (Risperidone) SS Hypothyroidism Clonazepam C Nausea Levoxyl Obsessive-Compulsive (Levothyroxine Disorder Sodium) C Palpitations Multivitamins C Panic Reaction Vitamin C C Paranoia Calcium C Rash Vitamin B Complex Restlessness (Calcium Rhinorrhoea Pantothenate, Serotonin Syndrome Nicotinamide, Somnolence Pyridoxine C Tunnel Vision Hydroxyzine C Vertigo Benadryl C Vomiting Weight Increased Date:11/16/05ISR Number: 4829152-6Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13173919 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Abilify Tabs 10 Mg PS Otsuka Condition Aggravated Pharmaceutical Hallucination, Auditory Company, Ltd. ORAL 24 DAY Insomnia Solian C Nausea Stilnox C Weight Decreased Temesta C Zoloft C 22-Feb-2006 08:31 AM Page: 980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4829219-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13176508 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Abilify PS Otsuka Pharmaceutical Company, Ltd. Date:11/16/05ISR Number: 4829222-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13171186 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 10 Mg PS Otsuka Self Injurious Behaviour Pharmaceutical Company, Ltd. ORAL Nozinan SS ORAL Seroplex SS ORAL Seresta SS ORAL Seresta SS ORAL Mepronizine SS ORAL Codoliprane SS ORAL Date:11/16/05ISR Number: 4829510-XReport Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13144407 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Aripiprazole PS Otsuka Initial or Prolonged Liver Function Test Pharmaceutical Abnormal Company, Ltd. ORAL Date:11/16/05ISR Number: 4829563-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13172614 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify PS Otsuka Initial or Prolonged Bipolar Disorder Pharmaceutical Company, Ltd. ORAL Ativan C Eskalith Cr C Flexeril C Seroquel C Trileptal C Date:11/16/05ISR Number: 4831185-0Report Type:Direct Company Report #CTU 263221 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Abilify 10mg PS 10MG ONCE Dysphagia DAILY Dyspnoea Musculoskeletal Stiffness 22-Feb-2006 08:31 AM Page: 981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/05ISR Number: 4830309-9Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13160817 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Excitability Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Flight Of Ideas Pharmaceutical Mania Company, Ltd. ORAL Risperdal C "several years" Zuclopenthixol C Carbamazepine C Date:11/17/05ISR Number: 4830319-1Report Type:Expedited (15-DaCompany Report #SI-BRISTOL-MYERS SQUIBB COMPANY-13173166 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Abnormal Abilify PS Otsuka Heart Rate Irregular Pharmaceutical Labile Blood Pressure Company, Ltd. ORAL 21 DAY Palpitations Risperidone C ORAL Cipralex C ORAL Zolpidem C ORAL Lorazepam C ORAL Date:11/17/05ISR Number: 4832502-8Report Type:Direct Company Report #CTU 263330 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Sertraline PS ORAL 100 MG DAILY Initial or Prolonged Blood Pressure Systolic PO SEVERAL Increased YEARS Dehydration Aripiprazole SS ORAL 10 MG AT Drug Interaction BEDTIME DAILY Extrapyramidal Disorder PO 1 MON Fall Ranitidine C Feeling Jittery Alprazolam C Headache Alubuterol C Hyperhidrosis Advair C Influenza Like Illness Motor Dysfunction Nausea Neurological Symptom Tachycardia Tremor Vomiting Date:11/18/05ISR Number: 4831169-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13115944 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hallucination Pharmaceutical Insomnia Company, Ltd. ORAL Mental Disorder Xanax C Multiple Fractures Inovan C Suicide Attempt 22-Feb-2006 08:31 AM Page: 982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/05ISR Number: 4831821-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13139571 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Anxiety Pharmaceuticals Condition Aggravated Europe Limited ORAL 21 DAY Hallucination, Auditory Date:11/18/05ISR Number: 4831824-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13174875 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Shock Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/21/05ISR Number: 4832430-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13179106 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Date:11/21/05ISR Number: 4833273-1Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13177928 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Abilify PS Otsuka Initial or Prolonged Parkinsonism Pharmaceuticals Restlessness Europe Limited ORAL reduced to 15 Salivary Hypersecretion mg daily due Trismus to the event 1 WK Date:11/21/05ISR Number: 4836248-1Report Type:Direct Company Report #CTU 263555 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drooling Haloperidol 5 Mg PS ORAL PRN PO Dysphagia Aripiprazole 5 Mg SS BID Fall Keppra C Headache Topamax C Mydriasis Motrin C Neuroleptic Malignant Ativan C Syndrome Haldol C Cogentin C Benadryl C Trazodone C Date:11/22/05ISR Number: 4834124-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13181524 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Methadone SS Xanax SS Norset C Noctamide C Date:11/22/05ISR Number: 4834433-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13181060 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain In Extremity Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Zopiclone C Date:11/22/05ISR Number: 4834939-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13162276 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Faecal Incontinence Abilify PS Otsuka Sedation Pharmaceuticals Urinary Incontinence Europe Limited ORAL Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Oral Solution SS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Oral Solution SS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Oral Solution SS Otsuka Pharmaceuticals Europe Limited ORAL Concerta C Strattera C Ritalin C Ddavp C Tofranil C Date:11/22/05ISR Number: 4837295-6Report Type:Expedited (15-DaCompany Report #HQWYE651604APR04 Age:25 YR Gender:Female I/FU:F Outcome PT Other Drug Exposure During Pregnancy Foetal Cardiac Disorder Foetal Disorder Foetal Heart Rate Decreased Hydronephrosis Kidney Small Limb Malformation 22-Feb-2006 08:31 AM Page: 984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ureteric Dilatation Report Source Product Role Manufacturer Route Dose Duration Health Efexor Xr Professional 9venlafaxine Other Hydrochloride, Capsule, Extended Release) PS ORAL 75 MG 1X PER 1 DAY, ORAL Abilify (Aripiprazole, ) SS ORAL 15 MG 1X PER 1 DAY, ORAL 65 DAY Effexor (Venlafaxine Hydrochloride, Tablet) SS Olanzapine (Olanzapine) C Haloperidol (Haloperidol) C Dicloxacillin (Dicloxacillin) C Alprazolam (Alprazolam) C Date:11/22/05ISR Number: 4837313-5Report Type:Expedited (15-DaCompany Report #S05-UKI-01727-01 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Cipralex Other Gait Disturbance Health (Escitalopram) PS ORAL 10 MG QD PO Movement Disorder Professional Abilify SS ORAL 15 MG QD PO Muscle Rigidity Other Abilify SS ORAL 10 MG QD PO Tremor Amisulpride (Amisulpride) C Unspecified Oral Contraceptives (Oral Contraceptive Nos) C Date:11/23/05ISR Number: 4835873-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13189949 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Aripiprazole PS Otsuka Initial or Prolonged Homicidal Ideation Pharmaceuticals Suicidal Ideation Europe Limited ORAL Aripiprazole SS Otsuka Pharmaceuticals Europe Limited ORAL Marijuana SS Date:11/23/05ISR Number: 4836381-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13133889 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Family Stress Aripiprazole PS Otsuka Initial or Prolonged Hallucination, Auditory Pharmaceuticals Other Homicidal Ideation Europe Limited ORAL 22 WK Suicidal Ideation 22-Feb-2006 08:31 AM Page: 985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/05ISR Number: 4838353-2Report Type:Expedited (15-DaCompany Report #2005042736 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Neurontin Initial or Prolonged Diarrhoea Health (Gabapentin) PS ORAL 300 MG (100 Other Drug Ineffective Professional MG, 3 IN 1 Influenza D), ORAL Palpitations Gabapentin Pharmaceutical Product (Gabapentin) SS 2700 MG (1 IN Complaint 1 TOTAL) Somnolence Abilify Vomiting (Aripiprazole) SS Lithium (Lithium) C Prevacid (Lansoprazole) C Date:11/23/05ISR Number: 4838954-1Report Type:Direct Company Report #CTU 263699 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Wellbutrin Sr 100 Depression Mg Glaxo Smith Drug Clearance Decreased Kline PS Glaxo Smith Kline ORAL 200 MG IN AM, Drug Toxicity 100 MG 4:00 Fall PM TWICE Grand Mal Convulsion DAILY PO Hallucination, Visual Ability 10 Mg Head Injury Bristol Meyers SS Bristol Meyers ORAL 10 MG ONCE Limb Injury DAILY PO Mood Swings Overdose Skin Laceration Speech Disorder Suicidal Ideation Date:11/25/05ISR Number: 4845437-1Report Type:Expedited (15-DaCompany Report #HQWYE651604APR05 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congenital Hydronephrosis Health Efexor Xr Drug Exposure During Professional (Venlafaxine Pregnancy Other Hydrochloride, Finger Deformity Capsule, Extended Heart Disease Congenital Release) PS ORAL 75 MG 1X PER Kidney Small 1 DAY, ORAL Limb Malformation Abilify Ureteric Dilatation (Aripiprazole, ) SS 15 MG 1X PER 1 DAY 65 DAY Efexor (Venlafaxine Hydrochloride, Tablet) SS Olanzapine (Olanzapine) C Haloperidol (Haloperidol) C Dicloxacillin (Dicloxacillin) C Alprazolam (Alprazolam) C 22-Feb-2006 08:31 AM Page: 986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4837253-1Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12962783 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Extrapyramidal Disorder Abilify PS Otsuka Other Hypertonia Pharmaceuticals Masked Facies Europe Limited ORAL Valproic Acid C Clorimipramine C Dipotassium Clorazepate C Date:11/28/05ISR Number: 4837773-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13182563 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Abilify Tabs 20 Mg PS Otsuka Other Phosphokinase Increased Pharmaceuticals Mental Impairment Europe Limited ORAL Dosage: 10 mg White Blood Cell Count 2004 -> Increased increased to 15 mg on unknown date Oxybutynin C ORAL Duloxetine Hcl C ORAL Clozaril C ORAL Hyoscine C ORAL Fluoxetine Hcl C ORAL Date:11/29/05ISR Number: 4839222-4Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13187521 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Abilify PS Otsuka Tachycardia Pharmaceuticals Europe Limited ORAL 15 mg 04Nov05 to 08Nov05; 30 mg 08Nov05 to 14Nov05; 15 mg on Metoprolol C Trevilor C Solian C Seroquel C reduced to 200 mg Date:11/30/05ISR Number: 4840858-5Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13144407 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Fibrosis Aripiprazole PS Otsuka Initial or Prolonged Jaundice Pharmaceuticals Liver Function Test Europe Limited ORAL Abnormal 22-Feb-2006 08:31 AM Page: 987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840929-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741849 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Premature Baby Pharmaceuticals Europe Limited ORAL Titrated 15mg to 0 mg/day at delivery and for 3 months after Prenatal Vitamins C Date:11/30/05ISR Number: 4840931-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12781274 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Deja Vu Pharmaceuticals Delusion Europe Limited ORAL Increased to Drug Ineffective 30 mg/day on Psychotic Disorder 30-Nov-2004; then 20 mg (date not Depakote C Prolixin C Apothecon INTRAMUSCULAR Benadryl C Ativan C Date:11/30/05ISR Number: 4840932-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12889192 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify PS Otsuka Nightmare Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840933-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12961348 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Abilify PS Otsuka Fatigue Pharmaceuticals Somnolence Europe Limited ORAL Also reported Vision Blurred as 10 mg/day 1 YR Weight Increased Aspirin C Digoxin C Wellbutrin C Date:11/30/05ISR Number: 4840935-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13009378 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertrophy Breast Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 1 YR 22-Feb-2006 08:31 AM Page: 988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840936-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13022520 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 1 YR Ethambutol C Isoniazid C Rifampin C Date:11/30/05ISR Number: 4840937-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13027719 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Metrorrhagia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Dosage increased to 5mg daily on 05-Jul-2005 1 MON Allegra C Singulair C Date:11/30/05ISR Number: 4840938-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13039227 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Concerta C Ritalin C Date:11/30/05ISR Number: 4840939-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13042163 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Oedema Peripheral Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 1 YR Lamictal C Topamax C Date:11/30/05ISR Number: 4840940-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13045083 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 1 MON Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL 1 MON Paxil C Lipitor C Imitrex C Hydrocodone + 22-Feb-2006 08:31 AM Page: 989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetaminophen C Dose value: 5/500 Verapamil C Zantac C Date:11/30/05ISR Number: 4840941-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13045166 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Ulcer Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840942-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13047790 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 6 WK Date:11/30/05ISR Number: 4840943-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13052691 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Abilify PS Otsuka Initial or Prolonged Parkinsonism Pharmaceuticals Europe Limited ORAL 2 WK Lithobid C Klonopin C Lunesta C Ambien C Sonata C Lithium C Date:11/30/05ISR Number: 4840944-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13058417 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Rolling Abilify PS Otsuka Pharmaceuticals Europe Limited 6 MON Cymbalta C Date:11/30/05ISR Number: 4840945-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13058532 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Abilify PS Otsuka Tachycardia Pharmaceuticals Weight Increased Europe Limited 22-Feb-2006 08:31 AM Page: 990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840946-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13059688 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 5 WK Xanax C Synthroid C Desipramine C Tamoxifen C Miralax C Lexapro C Protonix C Date:11/30/05ISR Number: 4840947-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13060660 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Abilify Tabs 15 Mg PS Otsuka Convulsion Pharmaceuticals Hallucination, Auditory Europe Limited ORAL Dosage: Hallucination, Visual initiated at Insomnia 5mg daily the Mania first 2 Paranoia weeks, Suicide Attempt Carnitine C Coenzyme-Q10 C Topamax C Lithium C Melatonin C Date:11/30/05ISR Number: 4840948-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13060975 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Abilify PS Otsuka Muscle Spasms Pharmaceuticals Sensory Loss Europe Limited Benztropine C Inderal C Stelazine C Lithium C Date:11/30/05ISR Number: 4840949-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063094 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Abilify Tabs PS Otsuka Thinking Abnormal Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840950-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063292 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs PS Otsuka Vomiting Pharmaceuticals 22-Feb-2006 08:31 AM Page: 991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Europe Limited ORAL 9 MON Metoclopramide Hcl C Sandoz Inc. (Geneva Pharm Tech) Date:11/30/05ISR Number: 4840951-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063540 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Trismus Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4840952-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063706 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 5 WK Levothyroxine Sodium C ORAL Ranitidine Hcl C Regulatory Health Authority Argentina Benztropine Mesylate C Sandoz Inc. (Geneva Pharm Tech) Alendronate Sodium C Asa C ORAL Date:11/30/05ISR Number: 4840953-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063839 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840954-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063870 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Abilify Tabs PS Otsuka Feeling Abnormal Pharmaceuticals Muscle Twitching Europe Limited Zoloft C Date:11/30/05ISR Number: 4840955-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063904 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 8 MON Depakote C 22-Feb-2006 08:31 AM Page: 992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840956-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063938 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 2 YR Date:11/30/05ISR Number: 4840957-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13063946 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited 1 YR Lithium C Depakote C Date:11/30/05ISR Number: 4840958-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13064258 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840959-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13064431 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840960-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13064746 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify PS Otsuka Vomiting Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4840961-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13065115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Abilify Tabs 30 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 1 YR Date:11/30/05ISR Number: 4840962-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13065248 Age:63 YR Gender:Female I/FU:I Outcome PT Confusional State Dysphasia 22-Feb-2006 08:31 AM Page: 993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceuticals Europe Limited Lexapro C Effexor C Trileptal C Date:11/30/05ISR Number: 4840963-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13067962 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Patient has been taking aripiprazole since the previous Depakote C Benztropine Mesylate C Sandoz Inc. (Geneva Pharm Tech) Date:11/30/05ISR Number: 4840964-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13068051 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Change Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840965-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13068366 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840966-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13069091 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhage Abilify PS Otsuka Pharmaceuticals Europe Limited Anesthesia C Date:11/30/05ISR Number: 4840967-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13069372 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceuticals 22-Feb-2006 08:31 AM Page: 994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Europe Limited ORAL Dosage increased to 10 mg daily Date:11/30/05ISR Number: 4840968-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13070883 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Gastrointestinal Disorder Pharmaceuticals Insomnia Europe Limited ORAL Somnolence Date:11/30/05ISR Number: 4840969-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13071089 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Lamictal C Date:11/30/05ISR Number: 4840970-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13071782 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Abilify Tabs PS Otsuka Somnolence Pharmaceuticals Europe Limited ORAL Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL Azulfidine C Allopurinol C Chondroitin C Glucosamine C Date:11/30/05ISR Number: 4840971-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13072517 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4840972-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13072608 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Abilify Tabs 5 Mg PS Otsuka Self-Injurious Ideation Pharmaceuticals 22-Feb-2006 08:31 AM Page: 995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Europe Limited ORAL initial dose of 1/4 of 5mg tab; then increased to 1/2 of 5mg Prozac C Prolixin C Apothecon Klonopin C Date:11/30/05ISR Number: 4840973-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13072848 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs PS Otsuka Hepatic Enzyme Increased Pharmaceuticals Psychomotor Hyperactivity Europe Limited ORAL Weight Increased Date:11/30/05ISR Number: 4840974-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13072897 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840975-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13072996 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Abilify PS Otsuka Muscle Spasms Pharmaceuticals Nausea Europe Limited Date:11/30/05ISR Number: 4840976-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13074026 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840977-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13075379 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Abilify Tabs 5 Mg PS Otsuka Increased Pharmaceuticals Europe Limited ORAL Dosage: Previously took Abilify 15mg daily, then 10mg 3 MON Multivitamin C Vitamin E C Calcium C 22-Feb-2006 08:31 AM Page: 996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840978-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13075395 Age:37 Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 3 MON Sertraline Hcl C Date:11/30/05ISR Number: 4840979-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13075494 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Increased Appetite Pharmaceuticals Insomnia Europe Limited ORAL 6 WK Weight Decreased Amitriptyline C Date:11/30/05ISR Number: 4840980-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13075726 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Abilify Tabs 15 Mg PS Otsuka Hospitalization - Phosphokinase Increased Pharmaceuticals Initial or Prolonged Renal Failure Acute Europe Limited ORAL 12 MON Rhabdomyolysis Abilify Tabs 15 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL 12 MON Lexapro C Date:11/30/05ISR Number: 4840981-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13076906 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 2 WK Date:11/30/05ISR Number: 4840982-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13077565 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen False Abilify PS Otsuka Positive Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4840983-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13077607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited 22-Feb-2006 08:31 AM Page: 997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840984-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13077680 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceuticals Europe Limited Zoloft C Ativan C Date:11/30/05ISR Number: 4840985-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13077854 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs 20 Mg PS Otsuka Back Pain Pharmaceuticals Rectal Haemorrhage Europe Limited ORAL Vertigo Date:11/30/05ISR Number: 4840986-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13077961 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840987-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13079454 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pancreatitis Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840988-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13079462 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs 30 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 9 MON Date:11/30/05ISR Number: 4840989-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13079595 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Abilify PS Otsuka Pharmaceuticals Europe Limited 22-Feb-2006 08:31 AM Page: 998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840990-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13079710 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited 1 WK Date:11/30/05ISR Number: 4840991-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13081484 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematocrit Increased Abilify PS Otsuka Haemoglobin Increased Pharmaceuticals Red Blood Cell Count Europe Limited Increased Zoloft C Date:11/30/05ISR Number: 4840992-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13081559 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Abilify PS Otsuka Angioneurotic Oedema Pharmaceuticals Dysarthria Europe Limited Muscle Spasms Cogentin C Date:11/30/05ISR Number: 4840993-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082144 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Dystonia Pharmaceuticals Europe Limited ORAL 6 MON Date:11/30/05ISR Number: 4840994-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082300 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Zoloft C Date:11/30/05ISR Number: 4840995-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082409 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 2 YR Paxil C 22-Feb-2006 08:31 AM Page: 999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840996-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082573 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 8 MON Escitalopram C Date:11/30/05ISR Number: 4840997-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13083217 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840998-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13083449 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4840999-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13083886 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Abilify PS Otsuka Corrected Interval Pharmaceuticals Prolonged Europe Limited ORAL Date:11/30/05ISR Number: 4841000-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13083993 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Swelling Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Provigil SS Date:11/30/05ISR Number: 4841001-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13084413 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Increased Abilify Tabs PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841002-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13084660 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceuticals 22-Feb-2006 08:31 AM Page: 1000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Europe Limited Zoloft C Ativan C Date:11/30/05ISR Number: 4841003-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13085477 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841004-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13085485 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841005-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13085493 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841007-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13086848 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disinhibition Abilify PS Otsuka Paraphilia Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841008-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13087648 Age:63 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841009-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13087713 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs 5 Mg PS Otsuka Fatigue Pharmaceuticals Insomnia Europe Limited ORAL Dosage: reduced to 2.5 mg daily for 6 days 1 MON Diazepam C Allegra C 22-Feb-2006 08:31 AM Page: 1001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Axid C Glyburide C Sandoz Inc. (Geneva Pharm Tech) Date:11/30/05ISR Number: 4841010-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13088893 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 5 Mg PS Otsuka Anorexia Pharmaceuticals Asthenia Europe Limited ORAL Headache Depakote C Insomnia Aspirin C Nausea Albuterol C Tremor Claritin C Vision Blurred Date:11/30/05ISR Number: 4841011-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13088927 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphonia Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841012-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13089990 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceuticals Europe Limited ORAL reduced dosage to 1/2 10 mg tablet 2 MON Ambien C Seroquel C Neurontin C 2 DAY Vitamin B Complex C Date:11/30/05ISR Number: 4841013-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13090063 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Abilify Tabs 5 Mg PS Otsuka Headache Pharmaceuticals Nausea Europe Limited ORAL 1 DAY Tinnitus Lexapro C Clonazepam C Ambien C Remeron C 22-Feb-2006 08:31 AM Page: 1002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841014-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13090071 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Methylin C Clonidine C Date:11/30/05ISR Number: 4841015-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13090147 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Abilify PS Otsuka Weight Decreased Pharmaceuticals Europe Limited Abilify SS Otsuka Pharmaceuticals Europe Limited Thyroid Supplement C Zyprexa C Effexor Xr C Date:11/30/05ISR Number: 4841016-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13090550 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Abilify Tabs 30 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841017-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13091020 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Abilify Tabs PS Otsuka Corrected Interval Pharmaceuticals Prolonged Europe Limited 3 MON Syncope Date:11/30/05ISR Number: 4841018-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13091178 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Dizziness Pharmaceuticals Fatigue Europe Limited Depakote Er C Dose value: 500 in the am, and 750 in the pm Adderall Xr C Levaquin C 22-Feb-2006 08:31 AM Page: 1003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841019-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13091558 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Abilify PS Otsuka Malaise Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841020-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13091921 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841021-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13092192 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841022-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13092317 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841023-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13092333 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841024-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13092366 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 20 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 1 YR Venlafaxine Hcl C Hydroxyzine C 22-Feb-2006 08:31 AM Page: 1004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841025-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13092382 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Reglan C Buspar C Bristol-Myers Squibb Company Trazodone Hcl Tabs C Apothecon Date:11/30/05ISR Number: 4841026-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13092390 Age:2 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceuticals Europe Limited Depakote C Date:11/30/05ISR Number: 4841027-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13092903 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Abilify Tabs PS Otsuka Initial or Prolonged Pancreatitis Pharmaceuticals Europe Limited ORAL Dosage: initiated at 10mg on 14-Oct-2004 Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL Dosage: initiated at 10mg on 14-Oct-2004 Trazodone Hcl C Apothecon Wellbutrin Xl C Date:11/30/05ISR Number: 4841028-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13093232 Age:5 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Abilify PS Otsuka Phosphatase Increased Pharmaceuticals Blood Bilirubin Increased Europe Limited Nexium C Date:11/30/05ISR Number: 4841029-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13093273 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Abilify Tabs 20 Mg PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Olanzapine SS Allegra C 22-Feb-2006 08:31 AM Page: 1005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Date:11/30/05ISR Number: 4841030-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13094958 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 4 WK Date:11/30/05ISR Number: 4841031-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13094990 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841032-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13095047 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Abilify Tabs PS Otsuka Oedema Peripheral Pharmaceuticals Europe Limited ORAL duration > 1 year 1 YR Date:11/30/05ISR Number: 4841033-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13095096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Abilify PS Otsuka Non-Insulin-Dependent Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841034-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13095328 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL increased from 15 mg to 20 mg the 7th month of therapy 7 MON Date:11/30/05ISR Number: 4841035-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13095559 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Abilify Tabs PS Otsuka Initial or Prolonged Parkinsonism Pharmaceuticals Europe Limited ORAL 30 DAY 22-Feb-2006 08:31 AM Page: 1006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841036-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13096029 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841037-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13096110 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841038-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13096417 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oculogyration Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Lexapro C Date:11/30/05ISR Number: 4841039-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13096607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Micrographia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841040-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13097621 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841041-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13098702 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Abilify Tabs 5 Mg PS Otsuka Anorexia Pharmaceuticals Blood Pressure Increased Europe Limited Erectile Dysfunction Ambien C every 3 Hypoaesthesia Oral nights Insomnia Clonidine C Weight Decreased Klonopin C Tylenol + Codeine C 22-Feb-2006 08:31 AM Page: 1007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841042-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13099262 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841043-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13099288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841044-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13099411 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Abilify Tabs 15 Mg PS Otsuka Muscle Rigidity Pharmaceuticals Europe Limited originally prescribed aripiprazole 10 mg for 6 months Date:11/30/05ISR Number: 4841045-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13100995 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Abilify PS Otsuka Decreased Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841046-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13101118 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841047-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13101266 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Burning Sensation Abilify Tabs 15 Mg PS Otsuka Dry Mouth Pharmaceuticals Urinary Retention Europe Limited ORAL 2 WK Vision Blurred Remeron C ORAL 2 WK 22-Feb-2006 08:31 AM Page: 1008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841048-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13101423 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841049-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13101514 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asperger'S Disorder Abilify Tabs 10 Mg PS Otsuka Food Craving Pharmaceuticals Libido Increased Europe Limited orinigally Low Density Lipoprotein prescribed Increased aripirazole 5 Thirst mg in Dec Weight Increased 2004 Topamax C Date:11/30/05ISR Number: 4841050-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13102629 Age:60 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841052-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13102991 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hot Flush Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 5 MON Zoloft C Lipitor C Inhalers C Date:11/30/05ISR Number: 4841053-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13103197 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Low Density Lipoprotein Pharmaceuticals Increased Europe Limited ORAL 10 MON Weight Increased Date:11/30/05ISR Number: 4841054-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13104641 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dental Caries Abilify Tabs PS Otsuka Tooth Discolouration Pharmaceuticals Europe Limited ORAL 3 YR Valium C 22-Feb-2006 08:31 AM Page: 1009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propranolol C Lexapro C Date:11/30/05ISR Number: 4841055-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13105317 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs 5 Mg PS Otsuka Headache Pharmaceuticals Insomnia Europe Limited interrupted Menstruation Irregular for 3 weeks; Nightmare restarted at Somnolence 15 mg daily Vision Blurred on 7 WK Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited interrupted for 3 weeks; restarted at 15 mg daily on 7 WK Haldol C Depakote C Date:11/30/05ISR Number: 4841057-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13107495 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 1 YR Depakote C 5 MON Carbamazepine C 5 MON Adderall C 5 MON Date:11/30/05ISR Number: 4841058-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13107529 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eyelid Ptosis Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL reduced to 1/2 tab bid on 02-Aug-05, then 1/2 tab qam 2 YR Abilify Tabs 10 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL reduced to 1/2 tab bid on 02-Aug-05, then 1/2 tab qam 2 YR 22-Feb-2006 08:31 AM Page: 1010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841059-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13109277 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841060-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13109582 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841061-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13109657 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Abilify PS Otsuka Contusion Pharmaceuticals Fatigue Europe Limited ORAL Risperdal C Naproxen C Synthroid C Amitriptyline C Minocycline C Protonix C Tylenol #3 C Zanaflex C Lexapro C Trazodone Hcl C Apothecon Date:11/30/05ISR Number: 4841062-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13109939 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841063-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13110085 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Weight Increased Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841064-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13110598 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841065-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13110879 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Abilify Tabs PS Otsuka Consciousness Pharmaceuticals Dysarthria Europe Limited Dyskinesia Depakote Er SS Somnolence Date:11/30/05ISR Number: 4841066-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13110911 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841067-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13110978 Age:40 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841068-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13111059 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841069-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112040 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841070-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112099 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited Lithium C Femara C 22-Feb-2006 08:31 AM Page: 1012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841071-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112149 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify Tabs PS Otsuka Dyskinesia Pharmaceuticals Europe Limited ORAL 10 mg or 15 mg (dose was not certain) daily for 3 months; 3 MON Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL 10 mg or 15 mg (dose was not certain) daily for 3 months; 3 MON Cymbalta C Risperdal C TERMINATED WHILE ON ARIPIPRAZOLE Benzodiazepines C "possibly"; currently not being taken Date:11/30/05ISR Number: 4841072-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112206 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841073-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112339 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Abilify PS Otsuka Weight Increased Pharmaceuticals Europe Limited ORAL Lexapro SS ORAL Oxybutynin C Date:11/30/05ISR Number: 4841074-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112446 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Oesophageal Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841075-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13112578 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Abilify Tabs PS Otsuka Pharmaceuticals 22-Feb-2006 08:31 AM Page: 1013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Europe Limited ORAL Ssri SS Date:11/30/05ISR Number: 4841076-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13113873 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Activity Abilify PS Otsuka Fatigue Pharmaceuticals Somnolence Europe Limited ORAL 4 MON Weight Increased Date:11/30/05ISR Number: 4841077-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13113881 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 5 MON Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL 5 MON Date:11/30/05ISR Number: 4841078-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13113949 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841079-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13114798 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify Tabs 10 Mg PS Otsuka Insomnia Pharmaceuticals Europe Limited ORAL Zoloft C Buspar C Bristol-Myers Squibb Company Diflucan C Detrol La C Estrogen C Levoxyl C Date:11/30/05ISR Number: 4841080-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13115761 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paranoia Abilify PS Otsuka Pharmaceuticals Europe Limited 2 YR 22-Feb-2006 08:31 AM Page: 1014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841081-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13116645 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Menorrhagia Abilify Tabs 30 Mg PS Otsuka Weight Increased Pharmaceuticals Europe Limited for several months Date:11/30/05ISR Number: 4841082-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13116678 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceuticals Europe Limited Trileptal SS Date:11/30/05ISR Number: 4841083-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13116934 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Abilify PS Otsuka Disorder Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841084-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13117536 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841085-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13117676 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonian Rest Tremor Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841086-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13117726 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Aripiprazole PS Otsuka Hospitalization - Syndrome Pharmaceuticals Initial or Prolonged Europe Limited ORAL Aripiprazole SS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841087-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13117767 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 6 MON Date:11/30/05ISR Number: 4841088-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13117783 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Depression Pharmaceuticals Europe Limited ORAL 9 MON Lithium C Effexor C Date:11/30/05ISR Number: 4841089-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13118088 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841090-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13118906 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Depakote C Date:11/30/05ISR Number: 4841091-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13119193 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841092-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13119862 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Paraesthesia Pharmaceuticals Europe Limited ORAL On 15-September- 2005, the original dose of 2 WK Propanolol Hydrochloride C Lithium C 22-Feb-2006 08:31 AM Page: 1016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Date:11/30/05ISR Number: 4841093-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13121025 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Abilify PS Otsuka Abnormal Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841094-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13121991 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 6 MON Atarax C Date:11/30/05ISR Number: 4841095-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13122122 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841096-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13122288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841097-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13122320 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 2 WK Date:11/30/05ISR Number: 4841098-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13123666 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841100-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13123807 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonian Rest Tremor Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Haldol C 15 YR Cogentin C 15 YR Date:11/30/05ISR Number: 4841101-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13124094 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 1 DAY Date:11/30/05ISR Number: 4841102-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13124128 Age:50 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Seroquel C Buspar C Bristol-Myers Squibb Company Sinemet C Bristol-Myers Squibb Company Date:11/30/05ISR Number: 4841103-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13125265 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841104-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13125273 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Abilify PS Otsuka Pharmaceuticals Europe Limited Ritalin SS Date:11/30/05ISR Number: 4841105-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13126024 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 1 MON 22-Feb-2006 08:31 AM Page: 1018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841106-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13126610 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka International Normalised Pharmaceuticals Ratio Fluctuation Europe Limited Coumadin I Bristol-Myers Squibb Company Dose value: 7.5 mg five times weekly, and 5.0 mg twice weekly. Date:11/30/05ISR Number: 4841107-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13126958 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 1 MON Zoloft C Valium C Date:11/30/05ISR Number: 4841108-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13127014 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841109-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13127972 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Withdrawal Syndrome Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841110-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13128210 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceuticals Myalgia Europe Limited ORAL Initiated at Neuroleptic Malignant 5 mg dialy Syndrome and titrated up to 15 mg daily 2 WK Depakote C Aricept C 22-Feb-2006 08:31 AM Page: 1019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841111-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13130661 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify Tabs PS Otsuka Sinusitis Pharmaceuticals Tremor Europe Limited ORAL Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL Lamictal C Lithium C Adderall Xr C Adderall C Contraceptive C Date:11/30/05ISR Number: 4841112-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13130737 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841113-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13131339 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Abilify Tabs PS Otsuka Constipation Pharmaceuticals Hepatic Enzyme Increased Europe Limited ORAL Insomnia Advil C Nausea Restlessness Weight Increased Date:11/30/05ISR Number: 4841114-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13131750 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen False Abilify Tabs PS Otsuka Positive Pharmaceuticals Europe Limited ORAL 3 WK Cogentin C Lithium C Wellbutrin C Date:11/30/05ISR Number: 4841115-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13133491 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Abilify PS Otsuka Hallucination Pharmaceuticals Psychotic Disorder Europe Limited Risperdal C Lithium C 22-Feb-2006 08:31 AM Page: 1020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841116-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13133574 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Seroquel C Depakote Er C Celexa C Lamictal C Topral C Asa C Date:11/30/05ISR Number: 4841117-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13133673 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841118-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13133905 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841119-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13134093 Age:50 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Abilify Tabs PS Otsuka Disorientation Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841120-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13134390 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Aspirin C 2 MON Protonix C 6 MON Tegretol C Remeron C 6 YR Date:11/30/05ISR Number: 4841121-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13134523 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration False Positive Laboratory Abilify Tabs PS Otsuka Result Pharmaceuticals Europe Limited 22-Feb-2006 08:31 AM Page: 1021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841122-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13134796 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs PS Otsuka Extrapyramidal Disorder Pharmaceuticals Fear Europe Limited 9 MON Strattera C Adderall Xr C Tenex C Lamictal C Date:11/30/05ISR Number: 4841123-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13135058 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Normal Newborn Abilify PS Otsuka Pregnancy Pharmaceuticals Europe Limited Clonazepam C Lexapro C Date:11/30/05ISR Number: 4841124-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13136338 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify PS Otsuka Nervousness Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841125-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13137138 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 30 Mg PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841126-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13137633 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Abilify Tabs 15 Mg PS Otsuka Hallucination, Auditory Pharmaceuticals Heart Rate Increased Europe Limited 2 MON Lisinopril C Lexapro C Wellbutrin C Nortriptyline C Levothyroxine C Arimidex C 22-Feb-2006 08:31 AM Page: 1022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841127-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13137773 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Paxil C Date:11/30/05ISR Number: 4841128-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13138045 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disorientation Abilify Tabs PS Otsuka Feeling Abnormal Pharmaceuticals Vision Blurred Europe Limited ORAL 2 DAY Seroquel C Xanax C Methadone C Date:11/30/05ISR Number: 4841129-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13138292 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 2 YR Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL 2 YR Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL 2 YR Depakote C Lithium C Date:11/30/05ISR Number: 4841130-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13139316 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841131-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13139670 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Swelling Face Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited 22-Feb-2006 08:31 AM Page: 1023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841133-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13139878 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841134-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13140017 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Taking 15 mg daily, then dose increased to 10 mg twice Lexapro C Date:11/30/05ISR Number: 4841135-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13140066 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841136-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13140215 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Micrographia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841137-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13140884 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841138-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13141247 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 2 WK Abilify Tabs 10 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL 2 WK Lithium C Xanax C 22-Feb-2006 08:31 AM Page: 1024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor C Tricor C Bactrim C Levaquin C Pyridium C Date:11/30/05ISR Number: 4841139-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13141288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Abilify PS Otsuka Drug Level Increased Pharmaceuticals Europe Limited Valproic Acid I Date:11/30/05ISR Number: 4841140-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13141403 Age:50 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Prozac C Diovan C Glucophage C Bristol-Myers Squibb Company Hydrochlorothiazide C Lipitor C Plavix C Regulatory Health Authority South Africa Ultram C Date:11/30/05ISR Number: 4841141-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142005 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Abilify PS Otsuka Initial or Prolonged Cardiac Failure Pharmaceuticals Diabetes Mellitus Europe Limited Inadequate Control Eye Disorder Weight Increased Date:11/30/05ISR Number: 4841142-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142096 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 1 WK 22-Feb-2006 08:31 AM Page: 1025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841143-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142138 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841145-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142146 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen Positive Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841146-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142203 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Other Europe Limited Date:11/30/05ISR Number: 4841147-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142252 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify Tabs PS Otsuka Dystonia Pharmaceuticals Orgasm Abnormal Europe Limited ORAL 4 MON Orthostatic Hypotension Date:11/30/05ISR Number: 4841148-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142328 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL Abilify Tabs 5 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL Haldol C Date:11/30/05ISR Number: 4841149-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142617 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify PS Otsuka Pharmaceuticals Europe Limited 22-Feb-2006 08:31 AM Page: 1026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841150-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13142641 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841151-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13143383 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Abilify Tabs PS Otsuka Gait Disturbance Pharmaceuticals Europe Limited Levodopa + Carbidopa C Comtan C Multivitamin C Docusate Sodium C Etodolac C Asacol C Date:11/30/05ISR Number: 4841152-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13143813 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Oral Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 2 YR Trileptal C Seroquel C Date:11/30/05ISR Number: 4841153-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13143862 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 2 WK Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL 2 WK Date:11/30/05ISR Number: 4841154-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13145107 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841155-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13145727 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 20 Mg PS Otsuka Pregnancy Pharmaceuticals 22-Feb-2006 08:31 AM Page: 1027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Europe Limited ORAL Dosage: reduced to 15 mg daily Lexapro C Glipizide C Glucophage C Bristol-Myers Squibb Company Date:11/30/05ISR Number: 4841156-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13146394 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceuticals Europe Limited Risperidone SS Seroquel SS Date:11/30/05ISR Number: 4841157-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13146451 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Panic Attack Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841158-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13147376 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify Tabs PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited Benzodiazepine C Suboxone C Date:11/30/05ISR Number: 4841160-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13148788 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841161-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13150107 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain In Extremity Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 26 DAY Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL 42 DAY Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL 13 DAY 22-Feb-2006 08:31 AM Page: 1028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL Aleve C Nortriptyline C ORAL Date:11/30/05ISR Number: 4841162-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13150156 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 1 YR Date:11/30/05ISR Number: 4841163-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13150164 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:11/30/05ISR Number: 4841164-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13150305 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gingival Bleeding Abilify Tabs PS Otsuka Oral Candidiasis Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841165-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13150495 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841166-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13151709 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 2 MON Klonopin C Date:11/30/05ISR Number: 4841167-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13151808 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 8 MON 22-Feb-2006 08:31 AM Page: 1029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841168-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13152285 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841169-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13152483 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841170-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13152871 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Depakote C Wellbutrin C Prozac C Seroquel C Date:11/30/05ISR Number: 4841171-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13153697 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited 1 YR Date:11/30/05ISR Number: 4841172-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13154018 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angina Pectoris Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 1 MON Antiviral C Date:11/30/05ISR Number: 4841173-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13154059 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Effexor C Lamictal C Zyprexa C 22-Feb-2006 08:31 AM Page: 1030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841174-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13154323 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Abilify PS Otsuka Initial or Prolonged Respiratory Distress Pharmaceuticals Other Europe Limited ORAL 1 DAY Buspar Tabs SS Bristol-Myers Squibb Company ORAL 1 DAY Lamictal SS 1 DAY Zoloft SS ORAL 1 DAY Ambien C Klonopin C Date:11/30/05ISR Number: 4841175-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13154380 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Abilify Tabs PS Otsuka Initial or Prolonged Dystonia Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841176-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13155338 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify Tabs 15 Mg PS Otsuka Phosphokinase Increased Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841177-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13155429 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 4 DAY Date:11/30/05ISR Number: 4841179-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13156153 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841180-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13156252 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841181-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13156294 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Abilify PS Otsuka Initial or Prolonged Agitation Pharmaceuticals Mood Swings Europe Limited ORAL Urinary Incontinence Lithium C Albuterol C Date:11/30/05ISR Number: 4841182-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13156476 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited 8 MON Date:11/30/05ISR Number: 4841183-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13156880 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Abilify PS Otsuka Weight Increased Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841184-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13157300 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Abilify Tabs PS Otsuka Consciousness Pharmaceuticals Dysarthria Europe Limited Dyskinesia Depakote Er SS Somnolence Date:11/30/05ISR Number: 4841185-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13157318 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Abilify Tabs PS Otsuka Consciousness Pharmaceuticals Dysarthria Europe Limited Dyskinesia Depakote Er SS Somnolence Date:11/30/05ISR Number: 4841186-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13157391 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Headache Pharmaceuticals Muscle Spasms Europe Limited ORAL Torticollis Adderall Xr C Effexor Xr C 22-Feb-2006 08:31 AM Page: 1032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841187-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13157417 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Abilify Tabs PS Otsuka Phosphokinase Increased Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841188-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13157961 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs PS Otsuka Depression Pharmaceuticals Europe Limited ORAL Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL Lithium C Depakote C Wellbutrin C Date:11/30/05ISR Number: 4841189-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158035 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Abilify PS Otsuka Pharmaceuticals Europe Limited Synthroid C Date:11/30/05ISR Number: 4841190-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158043 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Test Abnormal Abilify PS Otsuka Contusion Pharmaceuticals Europe Limited 14 MIN Date:11/30/05ISR Number: 4841191-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158316 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Urticaria Pharmaceuticals Europe Limited Seroquel SS Date:11/30/05ISR Number: 4841192-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158357 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited 22-Feb-2006 08:31 AM Page: 1033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841193-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158365 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841194-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158613 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Abilify Tabs 15 Mg PS Otsuka Difficulty In Walking Pharmaceuticals Hyperhidrosis Europe Limited ORAL Musculoskeletal Stiffness Baby Aspirin C Salivary Hypersecretion Niacin C Date:11/30/05ISR Number: 4841195-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158670 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Abilify PS Otsuka Abnormal Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841196-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158829 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited 9 MON Adderall SS Date:11/30/05ISR Number: 4841197-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13159256 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Screen False Abilify Tabs 5 Mg PS Otsuka Positive Pharmaceuticals Europe Limited Remeron C Prozac C Lunesta C Date:11/30/05ISR Number: 4841198-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13159595 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonian Rest Tremor Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4841199-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13159678 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Abilify Tabs 10 Mg PS Otsuka Weight Increased Pharmaceuticals Europe Limited ORAL 6 YR Nortriptyline C Date:11/30/05ISR Number: 4841200-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13159751 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify PS Otsuka Phosphokinase Increased Pharmaceuticals Muscle Spasms Europe Limited ORAL Myalgia Vitamins C Date:11/30/05ISR Number: 4841201-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13160296 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841202-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13161179 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Abilify PS Otsuka Drug Withdrawal Syndrome Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841203-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13161617 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Abilify PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841204-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13162276 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faecal Incontinence Abilify PS Otsuka Sedation Pharmaceuticals Urinary Incontinence Europe Limited Abilify SS Otsuka Pharmaceuticals Europe Limited Abilify SS Otsuka Pharmaceuticals Europe Limited Abilify Oral Solution SS Otsuka 22-Feb-2006 08:31 AM Page: 1035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals Europe Limited Abilify Oral Solution SS Otsuka Pharmaceuticals Europe Limited Abilify Oral Solution SS Otsuka Pharmaceuticals Europe Limited Concerta C Strattera C Ritalin C Ddavp C Tofranil C Date:11/30/05ISR Number: 4841205-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13162680 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Abilify PS Otsuka Initial or Prolonged Syndrome Pharmaceuticals Europe Limited Ativan C Blood Pressure Medication C Date:11/30/05ISR Number: 4841206-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13162698 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:11/30/05ISR Number: 4841207-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13162904 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Abilify PS Otsuka Gait Disturbance Pharmaceuticals Injury Europe Limited ORAL Motor Dysfunction Musculoskeletal Stiffness Pyrexia Date:11/30/05ISR Number: 4842083-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13151527 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Seresta SS ORAL 22-Feb-2006 08:31 AM Page: 1036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4843981-4Report Type:Direct Company Report #CTU 264132E Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Abilify 15mg Bms PS Bms ORAL 15 MG DAILY Gait Disturbance PO 3 MON Parkinsonism Prozac 20 Mg SS ORAL 20 MG DAILY Tremor PO 3 MON Protonix C Tylenol C Date:12/01/05ISR Number: 4843033-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13154059 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Contusion Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Effexor Xr C ORAL Lamictal C ORAL Zyprexa C ORAL Date:12/01/05ISR Number: 4844855-5Report Type:Direct Company Report #CTU 264212E Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parkinsonism Abilify 15 Mg Intervention to Salivary Hypersecretion Bristol-Myers Squibb PS Bristol-Myers Squibb Prevent Permanent Tardive Dyskinesia Impairment/Damage Date:12/05/05ISR Number: 4844776-8Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-13192422 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Abilify Tabs PS Otsuka Initial or Prolonged Facial Paresis Pharmaceuticals Vision Blurred Europe Limited ORAL duration: short term Citalopram Hydrobromide C Epilim C ORAL Fgf C duration: short term Date:12/05/05ISR Number: 4844789-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13196589 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Syncope Pharmaceuticals Europe Limited ORAL interrupted 05-May to 09-May-2004 Zeldox C ORAL Solian C ORAL Tavor I ORAL 1.5 mg/d 20-Apr 10 22-Feb-2006 08:31 AM Page: 1037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 10-May-2004; 1 mg 11-May to Date:12/05/05ISR Number: 4844794-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13196753 Age:30 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Aripiprazole PS Otsuka Pharmaceuticals Europe Limited ORAL Date:12/05/05ISR Number: 4844795-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13181524 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Methadone SS Xanax SS Norset C Noctamide C Date:12/05/05ISR Number: 4844937-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13196548 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Aripiprazole PS Otsuka Delusion Pharmaceuticals Flushing Europe Limited ORAL Psychotic Disorder Clonazepam C Propranolol C Temazepam C Propylthiouracil C Date:12/05/05ISR Number: 4844943-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12652228 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceuticals Convulsion Europe Limited ORAL 14 DAY Hyponatraemia Cipramil C ORAL 10 mg, then Loss Of Consciousness 20 mg since Vomiting 24-Jun-04;25- Jun-04, 30 mg Risperdal C ORAL reduced on 16-Jul-04 Tavor C ORAL 0.5 mg tid, since 24-Jun-04 0.5 mg qid 07-Jun-04 Co-Diovan C valsartan 80 mg/hctz 12.5 mg 17-Jun-04 22-Feb-2006 08:31 AM Page: 1038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/05ISR Number: 4845268-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13196712 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Abilify Tabs 15 Mg PS Otsuka Drug Interaction Pharmaceuticals Europe Limited ORAL Ergenyl C Sortis C Euglucon N C Beloc-Zok C Cipralex I Date:12/05/05ISR Number: 4847267-3Report Type:Direct Company Report #CTU 264375 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Incontinence Abilify 30mg PS 30MG 1 YR Micturition Urgency Date:12/06/05ISR Number: 4846036-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13196753 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Aripiprazole PS Otsuka Pharmaceuticals Europe Limited ORAL Date:12/06/05ISR Number: 4846487-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13196936 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Schizophrenia Pharmaceuticals Weight Increased Europe Limited 3 MON Date:12/06/05ISR Number: 4847054-6Report Type:Direct Company Report #CTU 264476 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Abilify PS 5MG 1 YR Initial or Prolonged Nausea Oral Intake Reduced Pancreatitis Acute Vomiting Date:12/06/05ISR Number: 4847076-5Report Type:Direct Company Report #CTU 264475E Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Abilify 5mg Bristol Myers Squib PS Bristol Myers Squib ORAL 2.5MG QAM PO 2 DAY 22-Feb-2006 08:31 AM Page: 1039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/05ISR Number: 4847317-4Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13201595 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Abilify PS Otsuka Pharmaceuticals Europe Limited Date:12/07/05ISR Number: 4847318-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13197926 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Abilify PS Otsuka Sleep Disorder Pharmaceuticals Europe Limited Date:12/07/05ISR Number: 4847346-0Report Type:Expedited (15-DaCompany Report #AU-ROCHE-426695 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Diazepam PS Roche ORAL Initial or Prolonged Consciousness Levlen C Drug Interaction Ferro-Gradumet C Mylanta C Nicabate C Midazolam Hydrochloride I Roche INTRAMUSCULAR Seroquel I UNKNOWN Droperidol I INTRAMUSCULAR Abilify I ORAL 10 DAY Lamictal I ORAL Epilim I ORAL Date:12/08/05ISR Number: 4848078-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13004551 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Abilify PS Otsuka Completed Suicide Pharmaceuticals Europe Limited ORAL Initiated at 10 mg and then increased to 15 mg daily Teralithe SS ORAL Temesta C Loxapac C Date:12/08/05ISR Number: 4848702-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13194592 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Abilify PS Otsuka Initial or Prolonged Cough Pharmaceuticals Other Europe Limited Abilify SS Otsuka Pharmaceuticals Europe Limited 22-Feb-2006 08:31 AM Page: 1040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Contraceptive C ORAL Date:12/08/05ISR Number: 4848704-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13198007 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Logorrhoea Abilify PS Otsuka Mania Pharmaceuticals Restlessness Europe Limited 15 mg from Sleep Disorder 29-Oct to 23-Nov-2004 Levopromazine C 200 mg, tapering 100 mg from 29-Oct-2004 to Risperidone C Date:12/08/05ISR Number: 4848721-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13192273 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Hypomania Pharmaceuticals Other Europe Limited ORAL 2 WK Sertraline C ORAL Depakote C ORAL Date:12/08/05ISR Number: 4848722-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13197652 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Abilify PS Otsuka Hypomania Pharmaceuticals Tremor Europe Limited ORAL Date:12/08/05ISR Number: 4848731-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13201082 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Abilify Tabs 10 Mg PS Otsuka Hospitalization - Agitation Pharmaceuticals Initial or Prolonged Europe Limited ORAL Solian SS Tercian SS ORAL 3 DAY Nozinan SS ORAL Date:12/09/05ISR Number: 4849329-3Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12937082 Age:29 YR Gender:Male I/FU:F Outcome PT Hospitalization - Bundle Branch Block Right Initial or Prolonged Photopsia Psychotic Disorder Restlessness 22-Feb-2006 08:31 AM Page: 1041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sexual Dysfunction Sleep Disorder Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Treatment Noncompliance Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 15 mg 19Jul04 to 26Sep04; 10 mg 27Sep04 to 19Jun05 Zeldox C tapering from 17-Jun-04 to 19-Jun-04 St John Wort C L-Thyroxine C Dose value: 100 ug Date:12/12/05ISR Number: 4850743-0Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-13199336 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Transient Ischaemic Pharmaceuticals Attack Europe Limited ORAL 5 MON Haldol C Litarex C Zopiklon C Disipal C Date:12/12/05ISR Number: 4851121-0Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13205968 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Electrolyte Imbalance Pharmaceuticals Hypokinesia Europe Limited ORAL duration 4-5 Pancreatitis days 5 DAY Pneumonitis Seroquel C Pyrexia Vomiting Date:12/12/05ISR Number: 4851140-4Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13202320 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify Tabs 10 Mg PS Otsuka Hypokinesia Pharmaceuticals Hypotension Europe Limited ORAL Pupil Fixed Lexapro SS ORAL Salivary Hypersecretion Istin C Tremor Date:12/12/05ISR Number: 4851141-6Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13127683 Age:28 YR Gender:Female I/FU:F Outcome PT Other Anosmia Fall 22-Feb-2006 08:31 AM Page: 1042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Head Injury Insomnia Malaise Report Source Product Role Manufacturer Route Dose Duration Nausea Abilify Tabs 15 Mg PS Otsuka Somnolence Pharmaceuticals Vomiting Europe Limited ORAL 21 DAY Risperdal C Imovane C Date:12/12/05ISR Number: 4851153-2Report Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-13201637 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 4 MON Penfluridol C tapered to 0 mg after initiation of aripiprazole 9 YR Date:12/12/05ISR Number: 4851155-6Report Type:Expedited (15-DaCompany Report #SI-BRISTOL-MYERS SQUIBB COMPANY-13173166 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Abilify Tabs 10 Mg PS Otsuka Heart Rate Irregular Pharmaceuticals Labile Blood Pressure Europe Limited ORAL 21 DAY Palpitations Risperidone C ORAL Cipralex C ORAL Zolpidem C ORAL Lorazepam C ORAL Date:12/12/05ISR Number: 4851412-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13102264 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Abilify Tabs 15 Mg PS Otsuka Hospitalization - Phosphokinase Increased Pharmaceuticals Initial or Prolonged Catatonia Europe Limited ORAL Other Flat Affect Haloperidol C INTRAMUSCULAR Muscle Rigidity Haloperidol C INTRAMUSCULAR Neuroleptic Malignant Thiamine C Syndrome Amoxicillin C Apothecon Pyrexia Liquid Nutritional C White Blood Cell Count Diazepam C ORAL Dosage: 2-6 Increased mg daily Diazepam C ORAL Dosage: 2-6 mg daily Lorazepam C ORAL Lorazepam C ORAL Lorazepam C INTRAMUSCULAR Lorazepam C INTRAMUSCULAR 22-Feb-2006 08:31 AM Page: 1043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/05ISR Number: 4851957-6Report Type:Direct Company Report #CTU 264888 E Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Abilify PS ORAL 5 MG BID PO Initial or Prolonged Date:12/13/05ISR Number: 4852033-9Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-13200555 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify PS Otsuka Initial or Prolonged Insomnia Pharmaceuticals Self Mutilation Europe Limited ORAL Olanzapine C Date:12/14/05ISR Number: 4853185-7Report Type:Expedited (15-DaCompany Report #NO-ROCHE-428092 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Rivotril PS Roche ORAL ON 18 OCTOBER Drug Interaction 2005 THE Fatigue PATIENT TOOK Syncope 1.5 MG DURING Vision Blurred 9 HOURS IN Abilify I ORAL 1 DAY Trilafon I ORAL Trilafon I ORAL 1 DAY Xanor I ORAL Xanor I ORAL 1 DAY Date:12/14/05ISR Number: 4853488-6Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13205190 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Abilify PS Otsuka Dyskinesia Pharmaceuticals Sexual Dysfunction Europe Limited ORAL Date:12/14/05ISR Number: 4853495-3Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13205232 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Pharmaceuticals Europe Limited ORAL Zyprexa C Date:12/14/05ISR Number: 4853728-3Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-13182241 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/05ISR Number: 4854458-4Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-13205224 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aripiprazole PS Otsuka Pharmaceuticals Europe Limited ORAL Zyprexa C Date:12/15/05ISR Number: 4854583-8Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12962783 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akinesia Abilify PS Otsuka Other Extrapyramidal Disorder Pharmaceuticals Hypertonia Europe Limited ORAL Masked Facies Valproic Acid C Clorimipramine C Dipotassium Clorazepate C Date:12/15/05ISR Number: 4854846-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051005783 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Risperdal PS ORAL 1 mg strength Initial or Prolonged Thromboplastin Time Risperdal SS ORAL Other Prolonged Abilify SS ORAL 15mg strength Blood Bicarbonate Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Ph Increased Blood Thrombin Increased Bone Pain C-Reactive Protein Increased Disorientation Drug Toxicity Haematoma Osteonecrosis Pain In Extremity Rhabdomyolysis Somnolence Suicide Attempt Tachycardia Wolff-Parkinson-White Syndrome Date:12/15/05ISR Number: 4859845-6Report Type:Expedited (15-DaCompany Report #S05-IRL-05648-01 Age:82 YR Gender:Female I/FU:I Outcome PT Other Convulsion Hypokinesia Hypotension Pupil Fixed 22-Feb-2006 08:31 AM Page: 1045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salivary Hypersecretion Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Escitalopram PS ORAL 20 MG QD PO Health Aripiprazole SS ORAL 10 MG QD PO Professional Istin (Amlodipine Other Besilate) C Date:12/16/05ISR Number: 4855605-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12855540 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Abilify Tabs 5 Mg PS Otsuka Life-Threatening Lung Neoplasm Malignant Pharmaceuticals Hospitalization - Respiratory Depression Europe Limited ORAL 2 DAY Initial or Prolonged Sedation Aspirin C Other Simvastatin C ORAL Thiamine C Amisulpride C Bisoprolol C ORAL Adcal-D3 C Date:12/19/05ISR Number: 4859720-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13206800 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Abilify PS Otsuka Paralysis Pharmaceuticals Vertigo Europe Limited ORAL Date:12/19/05ISR Number: 4859837-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE04056 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Drug Level Increased (Clozapine) PS Novartis Sector: Other General Physical Pharma ORAL up to Condition Abnormal 500mg/day Jaundice Cholestatic Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200mg/day Abilify SS UNKNOWN 10 mg, QD 148 DAY Date:12/20/05ISR Number: 4860935-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13189949 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Aripiprazole PS Otsuka Initial or Prolonged Homicidal Ideation Pharmaceuticals Suicidal Ideation Europe Limited ORAL non-complianc e since 30-Oct-2005; discharged on 15 mg daily Aripiprazole SS Otsuka Pharmaceuticals Europe Limited ORAL non-complianc 22-Feb-2006 08:31 AM Page: 1046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report e since 30-Oct-2005; discharged on 15 mg daily Marijuana SS Date:12/20/05ISR Number: 4860938-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13107404 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Abilify Tabs 5 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 6 DAY Risperidone C ORAL Bendroflumethiazide C Apothecon ORAL Amlodipine C ORAL Acetylsalicylic Acid C ORAL Date:12/20/05ISR Number: 4861529-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12925129 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Aripiprazole PS Otsuka Hospitalization - Asphyxia Pharmaceuticals Initial or Prolonged Confusional State Europe Limited UNKNOWN Cyanosis Zyprexa SS ORAL Infection Zopiclone C UNKNOWN Snoring Weight Increased Date:12/20/05ISR Number: 4865869-5Report Type:Expedited (15-DaCompany Report #2005159150 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Foreign Xanor (Alprazolam) PS ORAL 0.5 MG, ORAL Other Drug Interaction Health Rivotril Fatigue Professional (Clonazepam) SS ORAL 0.5 TO 1.5 MG Syncope DAILY, ORAL Vision Blurred Abilify (Aripiprazole) SS ORAL 10 MG (10 MG, 1 IN 1 D), ORAL Trilafon (Perphenazine) SS ORAL 4 MG (4 MG, 1 IN1 D), ORAL Date:12/21/05ISR Number: 4862586-2Report Type:Expedited (15-DaCompany Report #PHEH2005US13558 Age:28 YR Gender:Female I/FU:I Outcome PT Life-Threatening Constipation Other Cystitis Deafness Depression Diarrhoea Dysphonia Gastrooesophageal Reflux Disease 22-Feb-2006 08:31 AM Page: 1047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hiatus Hernia Hyperhidrosis Hypoaesthesia Report Source Product Role Manufacturer Route Dose Duration Kidney Infection Trileptal PS Novartis Sector: Liver Disorder Pharma ORAL 1000 mg BID Loss Of Consciousness and 500 mg HS Nasal Congestion Effexor SS Oedema Peripheral Mellaril SS Oesophageal Ulcer Prozac SS Haemorrhage Desipramine Osteoporosis Hydrochloride SS Paraesthesia Neurontin SS Rheumatoid Arthritis Levoxyl SS Skin Laceration Risperdal SS Suicide Attempt Depakene SS Ulcer Wellbutrin SS Vision Blurred Lithium Carbonate SS Vomiting Zyprexa SS Weight Decreased Thorazine SS Weight Increased Klonopin SS Yellow Skin Clomipramine SS Abilify SS Rocephin SS Date:12/21/05ISR Number: 4862833-7Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13211081 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify PS Otsuka Initial or Prolonged Confusional State Pharmaceuticals Disorientation Europe Limited ORAL Date:12/21/05ISR Number: 4862854-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13211149 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Abilify PS Otsuka Pharmaceuticals Europe Limited Geodon SS Lamictal SS Date:12/21/05ISR Number: 4866702-8Report Type:Expedited (15-DaCompany Report #S05-IRL-05648-01 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Escitalopram PS ORAL 20 MG QD PO Hypokinesia Health Aripiprazole SS ORAL 10 MG QD PO Hypotension Professional Istin (Amlodipine Pupil Fixed Other Besilate) C Salivary Hypersecretion Tremor 22-Feb-2006 08:31 AM Page: 1048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/05ISR Number: 4863996-XReport Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13205968 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Constipation Pharmaceuticals Electrolyte Imbalance Europe Limited ORAL duration 4-5 Hepatitis days 2 DAY Hypokinesia Seroquel C Pancreatitis Pneumonia Aspiration Pyrexia Vomiting Date:12/22/05ISR Number: 4864501-4Report Type:Expedited (15-DaCompany Report #FI-BRISTOL-MYERS SQUIBB COMPANY-13082227 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Prolactin Increased Aripiprazole PS Otsuka Sleep Disorder Pharmaceuticals Weight Increased Europe Limited Daily Dose: 5-10 mg 4 MON Olanzapine SS Fluoxetine Hcl SS Daily Dose: 5-10 mg per day Date:12/22/05ISR Number: 4867403-2Report Type:Direct Company Report #CTU 265581 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify PS Initial or Prolonged Dyspnoea Other Fatigue Required Feeling Abnormal Intervention to Hunger Prevent Permanent Multiple Allergies Impairment/Damage Suicidal Ideation Weight Increased Date:12/23/05ISR Number: 4865139-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13122510 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Catatonia Pharmaceuticals Other Delusion Europe Limited ORAL Flushing Clozapine C ORAL 3 MON Hyperhidrosis Sertraline C ORAL 3 MON Neuroleptic Malignant Zopiclone C ORAL Syndrome Levothyroxine C ORAL 3 MON Date:12/23/05ISR Number: 4865140-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13224050 Age:76 YR Gender:Female I/FU:I Outcome PT Other Hallucinations, Mixed Nausea 22-Feb-2006 08:31 AM Page: 1049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Photopsia Vomiting Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Haloperidol C Date:12/23/05ISR Number: 4865143-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13196753 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Aripiprazole PS Otsuka Pharmaceuticals Europe Limited ORAL Clozapine SS ORAL Date:12/23/05ISR Number: 4865146-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13221163 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Collapse Of Lung Abilify PS Otsuka Suicide Attempt Pharmaceuticals Europe Limited ORAL 3 WK Clozaril C Date:12/23/05ISR Number: 4865682-9Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13216437 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Date:12/23/05ISR Number: 4865684-2Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13214796 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myopia Abilify PS Otsuka Pharmaceuticals Europe Limited Duration of therapy: few months Date:12/23/05ISR Number: 4868694-4Report Type:Expedited (15-DaCompany Report #2004017260 Age:26 YR Gender:Female I/FU:F Outcome PT Death Akathisia Life-Threatening Anxiety Other Arrhythmia Condition Aggravated Depression Discomfort Fear Of Weight Gain Flashback 22-Feb-2006 08:31 AM Page: 1050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Frustration Headache Hypersomnia Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Geodon (Ziprasidone) PS 80 MG (2 IN 1 Loss Of Consciousness Health D), Mania Professional Prozac (Fluoxetine Restlessness Company Hydrochloride) SS (10 MG, 1 IN Sedation Representative 1 D), Sudden Cardiac Death Abilify Suicidal Ideation (Aripiprazole) SS Tension Lamictal Therapeutic Response (Lamotrigine) SS Decreased Treatment Noncompliance Date:12/27/05ISR Number: 4866176-7Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-13224571 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify Tabs 15 Mg PS Otsuka Phosphokinase Increased Pharmaceuticals Muscle Atrophy Europe Limited ORAL 6 MON Neuroleptic Malignant Syndrome Date:12/27/05ISR Number: 4866177-9Report Type:Expedited (15-DaCompany Report #KR-BRISTOL-MYERS SQUIBB COMPANY-13056403 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Abilify Tabs PS Otsuka Initial or Prolonged Increased Pharmaceuticals Aspartate Europe Limited ORAL Dosage: 15mg Aminotransferase 03-Jun-2005, Increased increased to Erythema Multiforme 30mg 05-Jun-2005, Diazepam SS ORAL 5 WK Procyclidine SS ORAL Flunitrazepam SS ORAL 5 WK Chlorprothixene SS ORAL Date:12/27/05ISR Number: 4866736-3Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12748570 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Abilify PS Otsuka Anxiety Pharmaceuticals Constipation Europe Limited Hyperhidrosis Risperidone C Insomnia Levothyroxine C Jaw Disorder Sodium Valproate C Self Injurious Behaviour Lithium C 22-Feb-2006 08:31 AM Page: 1051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/05ISR Number: 4866739-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13225396 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Date:12/27/05ISR Number: 4867970-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203524 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 2 MG, IN 1 Blood Triglycerides Professional DAY, ORAL Increased Abilify Drug Interaction (Aripiprazole) SS ORAL 15 MG, IN 1 Dyslipidaemia DAY, ORAL Date:12/28/05ISR Number: 4867251-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13226220 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:12/28/05ISR Number: 4867508-6Report Type:Expedited (15-DaCompany Report #AT-BRISTOL-MYERS SQUIBB COMPANY-13228705 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Abilify PS Otsuka Hospitalization - Fluid Intake Reduced Pharmaceuticals Initial or Prolonged Oral Intake Reduced Europe Limited Pulmonary Embolism Semap SS ORAL Restlessness Lexotanil SS ORAL Sleep Disorder Sinequan SS ORAL Date:12/28/05ISR Number: 4867667-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13220504 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceuticals Europe Limited Date:12/28/05ISR Number: 4867762-0Report Type:Expedited (15-DaCompany Report #US-KINGPHARMUSA00001-K200501613 Age:32 YR Gender:Female I/FU:I Outcome PT Other Alopecia Cough Dehydration Dizziness Dysphonia Hearing Impaired Hiatus Hernia 22-Feb-2006 08:31 AM Page: 1052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Memory Impairment Nasal Congestion Report Source Product Role Manufacturer Route Dose Duration Nephrolithiasis Levoxyl PS King Osteoarthritis Pharmaceuticals, Pyrexia Inc. ORAL Renal Disorder Abilify SS Renal Impairment Wellbutrin SS 150 mg, tid Rheumatoid Arthritis Trileptal Rhinorrhoea "Ciba-Geigy" SS 2000 mg, UNK Sedation Lithium SS 1200 mg, UNK Somnolence Zyprexa SS UNK, prn Suicide Attempt Thorazine SS UNK, prn Ulcer Clomipramine SS Unevaluable Event Risperidone SS Vision Blurred Effexor SS Vomiting Prozac SS Weight Decreased Depakene SS Weight Increased Yellow Skin Date:12/28/05ISR Number: 4870726-4Report Type:Expedited (15-DaCompany Report #2005-CZ-01430 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Foreign Fluoxetine Ivax 20 Dizziness Mg, Gelule Drug Interaction (Fluoxetine) PS ORAL 40 MG OM, Tremor ORAL Aripiprazole SS ORAL REDUCED, ORAL Lithium C Lansoprazole C Cefradine C Estradiol Valerate C Date:12/29/05ISR Number: 4868029-7Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13227517 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Abilify PS Otsuka Pregnancy Pharmaceuticals Europe Limited Date:12/29/05ISR Number: 4868030-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13230933 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Physical Assault Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Risperdal C 22-Feb-2006 08:31 AM Page: 1053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/05ISR Number: 4868031-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13230958 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Homicidal Ideation Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited Date:12/30/05ISR Number: 4869361-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13082094 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Abilify PS Otsuka Initial or Prolonged Cerebrovascular Accident Pharmaceuticals Other Chest Pain Europe Limited ORAL 4 WK Heart Rate Irregular Vasotec C Pollakiuria Cymbalta C Salivary Hypersecretion Vitamins C Thirst Cardizem C Transient Ischaemic Glucosamine C Attack Aspirin C Visual Disturbance Date:01/03/06ISR Number: 4870452-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13078324 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify PS Otsuka Initial or Prolonged Drug Toxicity Pharmaceuticals Europe Limited Trazodone Hcl Tabs SS Apothecon Clonidine SS Date:01/03/06ISR Number: 4870587-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13225396 Age:3 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL Date:01/03/06ISR Number: 4870803-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13228465 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Hallucination, Auditory Pharmaceuticals Insomnia Europe Limited ORAL 111 DAY Psychiatric Symptom Nozinan SS ORAL Seresta SS ORAL 111 DAY 22-Feb-2006 08:31 AM Page: 1054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/06ISR Number: 4870804-XReport Type:Expedited (15-DaCompany Report #NL-BRISTOL-MYERS SQUIBB COMPANY-13225941 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Abilify PS Otsuka Tooth Fracture Pharmaceuticals Europe Limited Date:01/03/06ISR Number: 4870811-7Report Type:Expedited (15-DaCompany Report #CN-BRISTOL-MYERS SQUIBB COMPANY-13231410 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Aripiprazole PS Otsuka Infarction Pharmaceuticals Europe Limited ORAL Date:01/03/06ISR Number: 4870978-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13226915 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Abilify Tabs 5 Mg PS Otsuka Prolonged Pharmaceuticals Europe Limited ORAL Celexa C Date:01/03/06ISR Number: 4870993-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13224548 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Abilify PS Otsuka Initial or Prolonged Abdominal Pain Upper Pharmaceuticals Dizziness Europe Limited Headache Trileptal C Celexa C Trazodone Hcl C Apothecon Date:01/04/06ISR Number: 4871635-7Report Type:Expedited (15-DaCompany Report #PHEH2005US13789 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril PS Novartis Sector: Drug Ineffective Pharma Unk, Unk 3285 DAY Somnolence Abilify SS Date:01/04/06ISR Number: 4871677-1Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-13224571 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Abilify Tabs 15 Mg PS Otsuka Phosphokinase Increased Pharmaceuticals Muscle Atrophy Europe Limited ORAL 6 MON Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 1055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/06ISR Number: 4871759-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13078324 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Abilify PS Otsuka Initial or Prolonged Drug Toxicity Pharmaceuticals Europe Limited Trazodone Hcl Tabs SS Apothecon Clonidine SS Date:01/04/06ISR Number: 4871897-6Report Type:Expedited (15-DaCompany Report #PHEH2005US13558 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alopecia Trileptal PS Novartis Sector: Other Constipation Pharma ORAL 1000 mg BID Cough and 500 mg HS Cystitis Effexor SS Deafness Mellaril SS Dehydration Prozac SS Depression Desipramine Diabetes Mellitus Hydrochloride SS Diarrhoea Neurontin SS Dizziness Levoxyl SS Dysphonia Risperdal SS Gastrooesophageal Reflux Depakene SS Disease Wellbutrin SS Hearing Impaired Lithium Carbonate SS Hiatus Hernia Zyprexa SS Hyperhidrosis Thorazine SS Hypersomnia Klonopin SS Hypoaesthesia Clomipramine SS Kidney Infection Abilify SS Lethargy Rocephin SS Liver Disorder Loss Of Consciousness Memory Impairment Nasal Congestion Nephrolithiasis Oedema Peripheral Oesophageal Ulcer Haemorrhage Osteoarthritis Osteoporosis Paraesthesia Pyrexia Renal Impairment Rheumatoid Arthritis Rhinorrhoea Sedation Suicide Attempt Ulcer Vision Blurred Vomiting Weight Decreased Weight Increased Yellow Skin 22-Feb-2006 08:31 AM Page: 1056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/06ISR Number: 4876114-9Report Type:Direct Company Report #CTU 266335 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify 10 Mgm Tab PS ORAL 10 MGM PO Initial or Prolonged Phosphokinase Increased Muscle Rigidity Neuroleptic Malignant Syndrome Date:01/09/06ISR Number: 4875638-8Report Type:Expedited (15-DaCompany Report #GB-KINGPHARMUSA00001-K200600003 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Kemadrin PS King Condition Aggravated Pharmaceuticals, Restlessness Inc. ORAL 5 mg, qd Suicidal Ideation Kemadrin SS King Pharmaceuticals, Inc. ORAL Aripiprazole SS ORAL 15 mg, qd 73440MIN Aripiprazole SS ORAL 30 mg, qd Citalopram C Clonazepam C Risperidone C Date:01/10/06ISR Number: 4876205-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13233234 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceuticals Europe Limited Date:01/10/06ISR Number: 4876206-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13233523 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Intracranial Abilify PS Otsuka Hypertension Pharmaceuticals Europe Limited Date:01/10/06ISR Number: 4878542-4Report Type:Direct Company Report #CTU 266561 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Food Craving Abilify; Increased Appetite Aripiprazole; Lack Of Satiety Otsuka Pharmaceuticals/Bris tol Myers PS Otsuka Pharmaceuticals/Bris tol Myers ORAL ORAL; 7.5 MILLIGRAM Methylphenidate C Sertraline C 22-Feb-2006 08:31 AM Page: 1057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/06ISR Number: 4877289-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13235486 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 10 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Zyprexa SS ORAL Date:01/11/06ISR Number: 4877293-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13235114 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL tab; duration: "several months" Date:01/11/06ISR Number: 4877294-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13235874 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL tabs 2 MON Date:01/11/06ISR Number: 4877849-4Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12937082 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Abilify PS Otsuka Initial or Prolonged Photopsia Pharmaceuticals Psychotic Disorder Europe Limited ORAL 15 mg 19Jul04 Restlessness to 26Sep04; Sexual Dysfunction 10 mg Sleep Disorder 27Sep04; 15 Suicidal Ideation mg 07Mar05 to Treatment Noncompliance Zeldox C tapering from 17-Jun-04 to 19-Jun-04 St John Wort C L-Thyroxine C Dose value: 100 ug Date:01/11/06ISR Number: 4881195-2Report Type:Direct Company Report #CTU 266581 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Headache Abilify , 7.5 Mg In Other Intracranial Pressure Am , 5 Mg In Pm PS ORAL PO BID Required Increased Intervention to Vith Nerve Paralysis Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 1058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/06ISR Number: 4881376-8Report Type:Direct Company Report #CTU 266681 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Zyprexa Zydis 5 Mg Tablet PS PRN RAGES USED INFREQUENTLY Abilify 5 Mg 1/2 Tab SS ORAL PO Q AM Guanfacine C Fluoxetine C Melatonin C Date:01/12/06ISR Number: 4879042-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13236930 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Intracranial Abilify PS Otsuka Hypertension Pharmaceuticals Europe Limited Date:01/12/06ISR Number: 4879188-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13237417 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Abilify PS Otsuka Hepatic Steatosis Pharmaceuticals Liver Function Test Europe Limited ORAL Dosage: Abnormal Reduced to 10 mg daily, then withdrawn Cipralex SS ORAL Tegretol C ORAL Thyroxine C ORAL Thyroxine C Nuelin C ORAL Date:01/13/06ISR Number: 4880067-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13204193 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Abilify PS Otsuka Rash Pharmaceuticals Sexual Dysfunction Europe Limited ORAL Tremor Levothyroxine C 2 YR Weight Increased Metformin Hcl C Bristol-Myers Squibb Company ORAL Date:01/13/06ISR Number: 4880071-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13236328 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/06ISR Number: 4880318-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13238969 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Excitability Pharmaceuticals Europe Limited ORAL Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL Rivotril C Date:01/16/06ISR Number: 4881508-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0505416A Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Lamictal PS Glaxosmithkline ORAL 150MG Twice Depressed Level Of per day Consciousness Abilify SS 15MG Per day Drug Prescribing Error Geodon SS 160MG At Medication Error night YR Sudden Cardiac Death Date:01/17/06ISR Number: 4881855-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE04056 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Drug Level Increased (Clozapine) PS Novartis Sector: Other Gamma-Glutamyltransferase Pharma ORAL up to Increased 400mg/day General Physical Abilify SS UNKNOWN up to 20 Condition Abnormal mg/day Jaundice Cholestatic Leukocytosis Date:01/17/06ISR Number: 4882286-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13236930 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Intracranial Abilify PS Otsuka Hypertension Pharmaceuticals Europe Limited Date:01/17/06ISR Number: 4882388-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13159330 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Abilify Tabs 15 Mg PS Otsuka Electrocardiogram St Pharmaceuticals Segment Elevation Europe Limited ORAL Atenolol C Sandoz Inc. (Geneva Pharm Tech) ORAL Simvastatin C ORAL Levothyroxine C ORAL Ibuprofen C ORAL 22-Feb-2006 08:31 AM Page: 1060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/06ISR Number: 4883409-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13221163 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Collapse Of Lung Abilify PS Otsuka Hospitalization - Condition Aggravated Pharmaceuticals Initial or Prolonged Drug Ineffective Europe Limited ORAL 3 WK Other Hallucination, Auditory Clozaril C Intentional Self-Injury Psychotic Disorder Suicide Attempt Treatment Noncompliance Date:01/18/06ISR Number: 4883888-XReport Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13242888 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Hyperthermia Pharmaceuticals Insomnia Europe Limited ORAL 1 MON Unresponsive To Pain Abilify Tabs 10 Mg SS Otsuka Stimuli Pharmaceuticals Europe Limited ORAL 1 MON Cipralex C Davedax C Delorazepam C Date:01/18/06ISR Number: 4886101-2Report Type:Direct Company Report #CTU 267148 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Abilify 20mg PS ORAL 20MG BID PO Initial or Prolonged Muscle Rigidity Lorazepam C Rhinitis Trazodone C Tramadol C Propranolol C Date:01/19/06ISR Number: 4884727-3Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13205711 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Akathisia Pharmaceuticals Grandiosity Europe Limited ORAL Insomnia Olanzapine C Irritability Risperidone C ORAL Persecutory Delusion Sodium Valproate C ORAL Dosage: Psychotic Disorder 1000/1500 Restlessness (unit Thinking Abnormal unspecified) Date:01/19/06ISR Number: 4884730-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13241617 Age:42 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Confusional State Hallucination, Auditory 22-Feb-2006 08:31 AM Page: 1061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Visual Overdose Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL 121 DAY Lepticur SS ORAL Date:01/19/06ISR Number: 4884732-7Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13216437 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceuticals Europe Limited ORAL Lithium Carbonate C Date:01/19/06ISR Number: 4885099-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12945432 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Date:01/19/06ISR Number: 4885214-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13243670 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Dissociative Disorder Pharmaceuticals Insomnia Europe Limited ORAL 59 DAY Temesta C Risperdal C Lepticur C Laroxyl C Theralene C Date:01/19/06ISR Number: 4885216-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13226220 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Date:01/19/06ISR Number: 4885327-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13240585 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Abilify Tabs 10 Mg PS Otsuka Hospitalization - Dysphasia Pharmaceuticals Initial or Prolonged Myasthenia Gravis Europe Limited ORAL 21-Nov-2005 Pain decreased to Restlessness 10 mg once Tremor daily 22-Feb-2006 08:31 AM Page: 1062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify Tabs 10 Mg SS Otsuka Pharmaceuticals Europe Limited ORAL 21-Nov-2005 decreased to 10 mg once daily Tamoxifen C Klonopin C Depakote C Date:01/19/06ISR Number: 4887707-7Report Type:Direct Company Report #USP 57597 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Dispensing Error Actos 30 Mg PS Takeda TABLET Intercepted Medication Abilify 30 Mg SS Otsuka Amenea TABLET Error Medication Error Date:01/20/06ISR Number: 4886403-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13224050 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucinations, Mixed Abilify PS Otsuka Nausea Pharmaceuticals Photopsia Europe Limited ORAL Vomiting Haloperidol C Date:01/20/06ISR Number: 4886647-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13248141 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Chronic Abilify Tabs 15 Mg PS Otsuka Chills Pharmaceuticals Nausea Europe Limited ORAL Oedema Peripheral Celexa C Pyrexia Diovan Hct C Sinusitis Quinine C Swelling Face Furosemide C Vomiting Atenolol C Sandoz Inc. (Geneva Weight Increased Pharm Tech) Metformin Hcl C Bristol-Myers Squibb Company Dmax C Phenytek C Estrostep Fe C Potassium C Prevacid C Loratadine C Date:01/20/06ISR Number: 4886652-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13205190 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Abilify PS Otsuka Dyskinesia Pharmaceuticals Sexual Dysfunction Europe Limited ORAL 22-Feb-2006 08:31 AM Page: 1063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/06ISR Number: 4886799-9Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13211081 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify Tabs PS Otsuka Initial or Prolonged Confusional State Pharmaceuticals Disorientation Europe Limited ORAL Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL Olanzapine C ORAL 12 MON Olanzapine C ORAL 12 MON Date:01/20/06ISR Number: 4889380-0Report Type:Expedited (15-DaCompany Report #2005168783 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Sertraline Initial or Prolonged Ear Pain Health (Sertraline) PS Other Flashback Professional Haloperidol Joint Stiffness (Haloperidol0 SS Nightmare Risperidone Persecutory Delusion (Risperidone) SS Suicidal Ideation Olanzapine Tardive Dyskinesia (Olanzapine) SS Tremor Benzatropine (Benzatropine) SS Aripiprazole (Aripiprazole) SS Date:01/23/06ISR Number: 4888204-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13189949 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Aripiprazole PS Otsuka Initial or Prolonged Homicidal Ideation Pharmaceuticals Suicidal Ideation Europe Limited ORAL non-complianc e since 30-Oct-2005; discharged on 15 mg daily Aripiprazole SS Otsuka Pharmaceuticals Europe Limited ORAL non-complianc e since 30-Oct-2005; discharged on 15 mg daily Marijuana SS Date:01/23/06ISR Number: 4888217-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13246129 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Abilify Tabs 15 Mg PS Otsuka Cardiac Failure Pharmaceuticals Congestive Europe Limited ORAL Renal Failure Prozac C Trazodone Hcl Tabs 22-Feb-2006 08:31 AM Page: 1064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 100 Mg C Apothecon Date:01/24/06ISR Number: 4891989-5Report Type:Direct Company Report #CTU 267613 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Aripiprazole 5 Mg PS TWICE A DAY Initial or Prolonged Distress Syndrome Pneumonia Aspiration Date:01/26/06ISR Number: 4892662-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13181524 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Methadone SS Xanax SS Norset C Noctamide C Date:01/26/06ISR Number: 4892693-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13227236 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Confusional State Pharmaceuticals Other Hyperthermia Europe Limited ORAL Dosage: 10 mg Neuroleptic Malignant daily Syndrome 15-Sep-2005 Pulse Abnormal to 22-Sep-2005; Lepticur C Rivotril C Date:01/27/06ISR Number: 4897228-3Report Type:Expedited (15-DaCompany Report #DSA_27602_2006 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Foreign Temesta PS ORAL 100 MG ONCE Multiple Drug Overdose Health PO Professional Mepronizine SS ORAL 4 TAB ONCE PO Other Alcohol SS ORAL DF UNK PO Temesta SS ORAL 4 MG Q DAY PO Temesta SS ORAL 1 MG UNK PO Mepronizine SS ORAL DF UNK PO Abilify SS ORAL 1 TAB Q DAY PO Depamide SS ORAL 3 TAB Q DAY PO Lepticur SS ORAL 20 MG Q DAY PO Nozinan /Net/ SS ORAL 200 MG Q DAY PO Theralene SS ORAL 30 GTT Q DAY PO 22-Feb-2006 08:31 AM Page: 1065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/06ISR Number: 4895511-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13251145 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Murder Abilify Tabs PS Otsuka Pharmaceuticals Europe Limited ORAL Haldol Decanoate C Date:01/30/06ISR Number: 4895592-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13253638 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Self-Injury Abilify PS Otsuka Psychotic Disorder Pharmaceuticals Europe Limited Quetiapine SS Date:01/30/06ISR Number: 4897795-XReport Type:Direct Company Report #CTU 268020 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Aripiprazole 30 Mg Initial or Prolonged Mental Disorder Tablets Treatment Noncompliance Bristol-Myers-Squibb PS Bristol-Myers-Squibb Date:01/31/06ISR Number: 4896402-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13251962 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Abilify Tabs 5 Mg PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Diuretic C Date:01/31/06ISR Number: 4896843-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13159769 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Aripiprazole PS Otsuka Initial or Prolonged Dyspnoea Pharmaceuticals Hypotension Europe Limited ORAL 3 MON Neuroleptic Malignant Quetiapine C Syndrome Carvedilol C Sepsis Gabapentin C Tachycardia Lorazepam C Furosemide C Enalapril C Ropinirole C Date:01/31/06ISR Number: 4896894-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13227145 Age:46 YR Gender:Female I/FU:F Outcome PT Hospitalization - Amnesia Initial or Prolonged Blood Pressure Increased Disorientation 22-Feb-2006 08:31 AM Page: 1066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Hyperhidrosis Mood Swings Report Source Product Role Manufacturer Route Dose Duration Pallor Abilify Tabs 15 Mg PS Otsuka Tearfulness Pharmaceuticals Europe Limited ORAL Thyroxine C ORAL Lamotrigine C ORAL Seroquel C ORAL Flu Vaccine C INTRAMUSCULAR Date:01/31/06ISR Number: 4896901-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13255286 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Abilify Tabs PS Otsuka Hospitalization - Death Pharmaceuticals Initial or Prolonged Europe Limited ORAL 15 DAY Date:01/31/06ISR Number: 4896922-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13253679 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Abilify Tabs PS Otsuka Other Overdose Pharmaceuticals Europe Limited Remeron C Percocet I Date:02/01/06ISR Number: 4897604-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13181060 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Abilify PS Otsuka Initial or Prolonged Abnormal Pharmaceuticals Pain In Extremity Europe Limited ORAL Zopiclone C Date:02/01/06ISR Number: 4897932-7Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13260690 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceuticals Other Europe Limited ORAL 2 MON Date:02/01/06ISR Number: 4901514-8Report Type:Direct Company Report #CTU 268384 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Abilify (Aripiprazole) PS ORAL 10 MG PO DAILY Citalopram C Lorazepam C Gabapentin C 22-Feb-2006 08:31 AM Page: 1067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ibuprofen C Hydrocodone/Apap C Date:02/02/06ISR Number: 4899038-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13256383 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Abilify Tabs PS Otsuka Somnolence Pharmaceuticals Europe Limited ORAL Dosage: 15 mg daily, then reduced to 10 mg daily for 3 to 4 months Date:02/02/06ISR Number: 4899100-1Report Type:Expedited (15-DaCompany Report #SK-BRISTOL-MYERS SQUIBB COMPANY-13259072 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Carcinoma Abilify PS Otsuka Life-Threatening Brain Oedema Pharmaceuticals Hospitalization - Bronchopneumonia Europe Limited ORAL Dosage: Initial or Prolonged Gastritis initiated at 7.5 mg daily from 13-Nov-2005 45 DAY Defobin C Coaxil C Date:02/02/06ISR Number: 4899109-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13258785 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceuticals Europe Limited Date:02/02/06ISR Number: 4899282-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13258108 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceuticals Europe Limited Date:02/02/06ISR Number: 4899283-3Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13258231 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 2 MON Depakine C 22-Feb-2006 08:31 AM Page: 1068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/06ISR Number: 4901823-2Report Type:Direct Company Report #CTU 268650 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Abilify 5 Mg Muscle Twitching Bristol-Meyers Tremor Squibb PS Bristol-Meyers Squibb ORAL 5 MG BID PO Date:02/03/06ISR Number: 4901826-8Report Type:Direct Company Report #CTU 268649 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Abilify 5 Mg Bristol Urticaria Meyers Squibb PS Bristol Meyers Squibb ORAL 5 MG DAILY PO 11 DAY Lexapro C Date:02/06/06ISR Number: 4901866-9Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13238969 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Excitability Pharmaceuticals Europe Limited ORAL Abilify SS Otsuka Pharmaceuticals Europe Limited ORAL Rivotril C Date:02/07/06ISR Number: 4903141-5Report Type:Expedited (15-DaCompany Report #AT-BRISTOL-MYERS SQUIBB COMPANY-13261755 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tongue Spasm Abilify PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL 8 DAY Solian C Haldol C INTRAVENOUS Diazepam C INTRAVENOUS Date:02/07/06ISR Number: 4905296-5Report Type:Direct Company Report #CTU 268811 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphasia Abilify 5mg. Life-Threatening Depression Doctor Samples PS ORAL 5MG. ONCE Difficulty In Walking DAILY PO Drug Level Increased Zoloft 50mg. Drug Screen Positive Kmart Pharmacy SS ORAL 50MG ONCE Feeling Abnormal DAILY PO Loss Of Consciousness Visual Disturbance 22-Feb-2006 08:31 AM Page: 1069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/06ISR Number: 4906448-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13264965 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 7 MON Xanax C Noctran C Date:02/09/06ISR Number: 4906562-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13228465 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Psychotic Disorder Pharmaceuticals Refusal Of Treatment By Europe Limited ORAL 111 DAY Patient Nozinan SS ORAL Seresta SS ORAL 111 DAY Date:02/09/06ISR Number: 4906565-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13265228 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Acute Abilify PS Otsuka Initial or Prolonged Respiratory Distress Pharmaceuticals Europe Limited ORAL Carbamazepine C Escitalopram C Haloperidol C Benzodiazepines C Date:02/10/06ISR Number: 4907790-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13264692 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Homicidal Ideation Pharmaceuticals Paranoia Europe Limited ORAL increased to 25 mg 8 WK Date:02/14/06ISR Number: 4910721-XReport Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-13275573 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceuticals Pyrexia Europe Limited Cisordinol C Date:02/14/06ISR Number: 4911072-XReport Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13271192 Age: Gender:Male I/FU:I Outcome PT Other Agitation Anxiety Delirium 22-Feb-2006 08:31 AM Page: 1070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fear Report Source Product Role Manufacturer Route Dose Duration Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL 8 DAY Alprazolam C Date:02/14/06ISR Number: 4911209-2Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-13279948 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Abilify PS Otsuka Fall Pharmaceuticals Europe Limited Abilify SS Otsuka Pharmaceuticals Europe Limited Abilify SS Otsuka Pharmaceuticals Europe Limited Triatec C Oxascand C Zoloft C Remeron C Heminevrin C Dose value: 50 mg/ml 18 ml Furix C Fragmin C Dose value: 5000 IE Date:02/15/06ISR Number: 4912556-0Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13211081 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Abilify Tabs PS Otsuka Initial or Prolonged Confusional State Pharmaceuticals Disorientation Europe Limited ORAL Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited ORAL Olanzapine C ORAL 12 MON Olanzapine C ORAL 12 MON Date:02/15/06ISR Number: 4912882-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13235114 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Treatment Noncompliance Pharmaceuticals Europe Limited ORAL ABILIFY: tablet (dose unknown) taken for duration of 3 4 MON 22-Feb-2006 08:31 AM Page: 1071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/06ISR Number: 4913823-7Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-13276431 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify Tabs PS Otsuka Fall Pharmaceuticals Therapy Non-Responder Europe Limited Abilify Tabs SS Otsuka Pharmaceuticals Europe Limited Rohipnol SS Thioridazine C Majeptil C Akineton C Date:02/16/06ISR Number: 4914024-9Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13247333 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Abilify Tabs 10 Mg PS Otsuka Dyskinesia Pharmaceuticals Trismus Europe Limited ORAL Prozac SS ORAL Date:02/16/06ISR Number: 4914279-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13276522 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Pharmaceuticals Europe Limited ORAL Seresta C ORAL Haloperidol C INTRAMUSCULAR long term treatment Date:02/17/06ISR Number: 4915120-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13273651 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Wellbutrin Xl C Celexa C Lithium C Date:02/17/06ISR Number: 4915779-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13253679 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Abilify Tabs 15 Mg PS Otsuka Other Overdose Pharmaceuticals Europe Limited ORAL 1 MON Remeron C ORAL 1 WK Percocet I ORAL 22-Feb-2006 08:31 AM Page: 1072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/06ISR Number: 4917110-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13278197 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify Tabs 15 Mg PS Otsuka Pharmaceuticals Europe Limited ORAL Risperdal C Effexor C Imovane C Seresta C 22-Feb-2006 08:31 AM Page: 1073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Summary report for FOI selections: Selection by inexact search of active ingredient: ARIPIPRAZOLE% Selection by inexact search of Tradename/Verbatim: ABILIFY% Total number of reports: 5,029 From: 01-NOV-1997 To: Present 22-Feb-2006 08:31 AM Page: 1074