Olanzapine - Congenital, Prenatal & Neonatal Adverse Rections


This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.

Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).

The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism."  This psychiatric drug fits that definition.



Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 4054840 4284338 01/30/2004 11/10/2003 Zyprexa MD Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, Maternal Drugs Affecting Foetus
4089256 4287834 02/05/2004 Zyprexa MD Cleft Lip, Maternal Drugs Affecting Foetus
F 4101705 4307115 02/06/2004 02/25/2004 Zyprexa MD Complications of Maternal Exposure To Therapeutic Drugs, Hospitalisation
M 4102073 4306854 11/03/2003 02/25/2004 Zyprexa MD Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus
F 4167992 4391641 06/07/2004 07/01/2004 Zyprexa Drug Exposure During Pregnancy
4168408 4393282 01/01/2003 07/01/2004 Zyprexa Convulsion, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Hypoxia
M 4191770 4421848 08/06/2004 Zyprexa MD Calcinosis, Cerebral Disorder, Cerebral Palsy, Congenital Varicella Infection, Drug Exposure During Pregnancy, Neonatal Disorder, Retinitis
5664763 4465900 09/29/2004 Zyprexa MD Abortion Spontaneous, Chromosome Abnormality, Drug Exposure During Pregnancy
5664763 4790967 10/05/2005 Zyprexa MD Abortion Spontaneous, Chromosome Abnormality, Drug Exposure During Pregnancy
5689424 4512500 11/24/2004 Zyprexa OT Drug Exposure During Pregnancy, Intra-Uterine Death, Umbilical Cord Around Neck
5695598 4522585 12/07/2004 Zyprexa Drug Exposure During Pregnancy, Feeding Problem In Newborn, Lethargy, Motor Dysfunction, Neonatal Disorder
5696408 4522548 01/01/2004 12/07/2004 Zyprexa MD Drug Exposure During Pregnancy, Large for Dates Baby, Mental Disability
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5721627 4553474 10/18/2004 01/12/2005 Olanzapine MD Prophylaxis, Psychotic Disorder Drug Exposure During Pregnancy, Foetal Distress Syndrome
F 5798044 4655812 04/15/2005 05/05/2005 Zyprexa MD Drug Exposure During Pregnancy, Ear Malformation, Hypoglycaemia
F 5801083 4659902 05/10/2005 Olanzapine MD Benign Hydatidiform Mole, Drug Exposure During Pregnancy
M 5815730 4680404 06/01/2005 Zyprexa MD Cardiac Disorder, Congenital Anomaly, Drug Exposure During Pregnancy, Rhabdomyoma, Tuberous Sclerosis
M 5819399 4686688 06/06/2005 Olanzapine MD Drug Exposure During Pregnancy, Premature Baby, Trisomy 21
5819399 5081604 08/11/2006 Olanzapine MD Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby, Trisomy 21
5819531 4686731 06/06/2005 Olanzapine Drug Exposure During Pregnancy, Gastroschisis
5819753 4687066 06/07/2005 Zyprexa OT Drug Exposure During Pregnancy, Intra-Uterine Death
M 5819753 4703970 06/28/2005 Zyprexa OT Foetal Heart Rate Deceleration, Intra-Uterine Death, Maternal Drugs Affecting Foetus
F 5821692 4686430 01/29/2005 06/06/2005 Zyprexa MD Drug Exposure During Pregnancy, Drug Toxicity, Intentional Misuse, Premature Labour, Suicide Attempt
F 5821692 4710594 01/29/2005 07/07/2005 Zyprexa MD Bipolar I Disorder Apgar Score Low, Depression, Drug Exposure During Pregnancy, Drug Toxicity, Intentional Misuse, Overdose, Premature Baby, Premature Labour, Suicide Attempt, Thyroxine Increased
5834272 4704492 06/28/2005 Zyprexa MD Drug Exposure During Pregnancy, Haemoglobin Increased, Neonatal Disorder, Neonatal Infection, Neonatal Pneumonia, Polycythaemia, Respiratory Rate Increased, Tension
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5882874 4771046 09/14/2005 Zyprexa MD Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Poor Weight Gain Neonatal, Premature Baby, Sedation
M 5882874 4798325 10/11/2005 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypoglycaemia Neonatal, Neonatal Oversedation, Poor Weight Gain Neonatal
5882874 4816176 10/26/2005 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Premature Baby
F 5907197 4803005 06/30/2005 10/13/2005 Olanzapine Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Poor Sucking Reflex, Postmature Baby
F 5907200 4803006 10/13/2005 Olanzapine Psychotic Disorder Anxiety, Drug Exposure During Pregnancy, Induced Labour, Pre-Eclampsia
F 5907200 4822049 11/03/2005 Olanzapine Psychotic Disorder Anxiety, Drug Exposure During Pregnancy, Pre-Eclampsia
F 5907200 4853352 01/01/2004 12/12/2005 Olanzapine Psychotic Disorder Anxiety, Drug Exposure During Pregnancy, Major Depression, Pre-Eclampsia, Psychotic Disorder
F 5914833 4806783 01/01/2005 10/19/2005 Zyprexa MD Acute Psychosis Acute Psychosis, Drug Exposure During Pregnancy
F 5914833 4821809 01/01/2005 11/03/2005 Zyprexa MD Acute Psychosis Acute Psychosis, Caesarean Section, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Psychotic Disorder
5918678 4815089 10/26/2005 Zyprexa MD Dandy-Walker Syndrome, Transmission of Drug Via Semen
F 5924958 4824462 11/08/2005 Olanzapine MD Schizoaffective Disorder Anaemia, Drug Exposure During Pregnancy, Galactorrhoea, Postpartum Disorder, Restlessness, Sleep Disorder
M 5924958 4824570 11/08/2005 Olanzapine MD Schizoaffective Disorder Anaemia, Blood Prolactin Increased, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Ineffective, Galactorrhoea, Postpartum Disorder, Prolonged Pregnancy, Restlessness, Sleep Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5925065 4824777 11/08/2005 Zyprexa MD Abortion Induced, Drug Exposure During Pregnancy, Multiple Cardiac Defects
5928362 4830136 11/14/2005 Zyprexa MD Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Large for Dates Baby
F 5931271 4832749 03/01/2000 11/17/2005 Zyprexa Anxiety Blood Pressure Fluctuation, Corrective Lens User, Gastric Ulcer, Hepatic Function Abnormal, Hiatus Hernia, Hypoacusis, Hysterectomy, Nephrolithiasis, Osteoporosis, Rheumatoid Arthritis, Suicide Attempt, Vision Blurred, Vomiting, Weight Decreased
F 5931271 4883724 05/01/1999 01/13/2006 Zyprexa Anxiety Blood Pressure Fluctuation, Drug Exposure During Pregnancy, Endometriosis, Gastric Ulcer, Haematochezia, Hepatic Function Abnormal, Hiatus Hernia, Hypoacusis, Menometrorrhagia, Nephrolithiasis, Osteoporosis, Rheumatoid Arthritis, Stress Ulcer, Suicide Attempt, Therapy Non-Responder, Vision Blurred, Vomiting, Weight Decreased
F 5931271 4883847 03/01/2000 01/13/2006 Zyprexa Anxiety Blood Pressure Fluctuation, Drug Exposure Before Pregnancy, Gastric Ulcer, Hepatic Function Abnormal, Hiatus Hernia, Hypoacusis, Hysterectomy, Nephrolithiasis, Osteoporosis, Rheumatoid Arthritis, Suicide Attempt, Vision Blurred, Vomiting, Weight Decreased
F 5931271 4907205 05/01/1999 02/07/2006 Zyprexa Anxiety Alopecia, Amnesia, Blood Pressure Fluctuation, Cough, Dehydration, Diabetes Mellitus, Dizziness, Dysphonia, Endometriosis, Gastric Ulcer, Haematochezia, Hepatic Function Abnormal, Hiatus Hernia, Hypoacusis, Lethargy, Menometrorrhagia, Nasal Congestion, Nephrolithiasis, Osteoarthritis, Osteoporosis, Pyrexia, Renal Impairment, Rheumatoid Arthritis, Rhinorrhoea, Sedation, Somnolence, Stress Ulcer, Suicide Attempt, Vision Blurred, Vomiting, Weight Decreased, Weight Increased, Yellow Skin
F 5931271 4909009 05/01/1999 02/09/2006 Zyprexa Anxiety Alopecia, Amnesia, Blood Pressure Fluctuation, Cough, Dehydration, Diabetes Mellitus, Dizziness Postural, Dysphonia, Gastric Ulcer, Haematemesis, Haematochezia, Hepatic Function Abnormal, Hiatus Hernia, Hydronephrosis, Hypoacusis, Jaundice, Lethargy, Menometrorrhagia, Nasal Congestion, Nephrolithiasis, Osteoarthritis, Osteoporosis, Pyrexia, Renal Impairment, Renal Mass, Rheumatoid Arthritis, Rhinorrhoea, Sedation, Somnolence, Stress Ulcer, Suicide Attempt, Vision Blurred, Vomiting, Weight Decreased, Weight Increased
F 5931271 4935839 05/01/1999 03/02/2006 Zyprexa Anxiety Alopecia, Amnesia, Blood Pressure Fluctuation, Cough, Dehydration, Diabetes Mellitus, Dizziness, Dysphonia, Endometriosis, Gastric Ulcer, Haematochezia, Hepatic Function Abnormal, Hiatus Hernia, Hydronephrosis, Hypoacusis, Lethargy, Menometrorrhagia, Nasal Congestion, Nephrolithiasis, Osteoarthritis, Osteoporosis, Pyrexia, Renal Disorder, Renal Impairment, Rheumatoid Arthritis, Rhinorrhoea, Sedation, Somnolence, Stress, Suicide Attempt, Ulcer, Vision Blurred, Vomiting, Weight Decreased, Weight Increased, Yellow Skin
5953892 4866878 02/01/2005 12/22/2005 Zyprexa MD Abortion Induced, Drug Exposure During Pregnancy, Foetal Growth Retardation
F 5960016 4872577 11/01/2005 01/03/2006 Zyprexa MD Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Floppy Infant
F 5960016 4882984 11/01/2005 01/13/2006 Zyprexa MD Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Floppy Infant
F 5961972 4872576 01/03/2006 Zyprexa MD Congenital Anomaly, Congenital Eyelid Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, Hypotonia, Nose Deformity, Poor Sucking Reflex, Posture Abnormal, Retrognathia, Vomiting
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5978752 4897238 01/01/2005 01/27/2006 Zyprexa LW Bipolar Disorder Drug Exposure During Pregnancy, Gestational Diabetes, Pneumonia
F 5997681 4919004 01/01/2000 02/16/2006 Zyprexa LW Bipolar Disorder Antepartum Haemorrhage, Drug Exposure During Pregnancy
F 5998813 4918737 01/01/2004 02/16/2006 Zyprexa LW Bipolar Disorder Drug Exposure During Pregnancy, Gestational Diabetes, Hyperemesis Gravidarum, Hyperglycaemia, Premature Labour
F 5998813 4935822 01/01/2004 03/02/2006 Zyprexa LW Bipolar Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Fibronectin Increased, Gestational Diabetes, Glucose Tolerance Impaired, Hyperemesis Gravidarum, Hyperglycaemia, Premature Labour
F 6049515 4999149 03/03/2006 05/09/2006 03/03/2006 Olanzapine MD Death Neonatal, Drug Exposure During Pregnancy, Premature Baby, Trisomy 13
6050660 5000105 05/09/2006 Olanzapine PH Congenital Anomaly, Drug Exposure During Pregnancy
6061340 5015762 08/01/2005 05/25/2006 Zyprexa OT Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Haemorrhage, Jaundice Neonatal, Placenta Praevia, Premature Baby, Respiratory Disorder Neonatal
6069234 5023126 06/05/2006 Olanzapine MD Congenital Eyelid Malformation, Drug Exposure During Pregnancy, Meningocele, Small for Dates Baby
6074157 5030068 04/01/2006 06/14/2006 Zyprexa MD Drug Exposure During Pregnancy, Ventricular Septal Defect
6083056 5045040 02/08/2006 07/05/2006 Zyprexa Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Sedation
6085061 5048620 07/05/2006 Zyprexa PH Congenital Hand Malformation, Drug Exposure During Pregnancy
F 6114266 5081471 08/10/2006 Zyprexa Cleft Palate, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6114266 5088963 08/22/2006 Zyprexa Cleft Palate, Drug Exposure During Pregnancy
6116458 5084800 08/14/2006 Zyprexa MD Drug Exposure During Pregnancy, Escherichia Infection, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome
6116458 5109702 05/14/2006 09/18/2006 Zyprexa MD Drug Use for Unknown Indication C-Reactive Protein Increased, Drug Exposure During Pregnancy, Escherichia Infection, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome
6126852 5096390 08/30/2006 Zyprexa Zydis MD Drug Exposure During Pregnancy, Premature Baby
F 6136791 5106520 05/31/2006 09/12/2006 Zyprexa MD Apgar Score Low, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Hyperbilirubinaemia Neonatal, Lung Disorder, Maternal Condition Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Sleep Apnoea Syndrome
6136791 5109716 05/31/2006 09/18/2006 Zyprexa MD Apgar Score Low, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Hyperbilirubinaemia Neonatal, Lung Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Sleep Apnoea Syndrome
F 6143445 5117981 09/01/2006 09/26/2006 Zyprexa OT Drug Exposure During Pregnancy, Trisomy 21
F 6143445 5118425 09/01/2006 09/26/2006 Zyprexa OT Drug Exposure During Pregnancy, Trisomy 21
F 6143445 5140030 08/23/2006 10/26/2006 Zyprexa OT Apgar Score Low, Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Trisomy 21
6154493 5130133 07/15/2005 10/13/2006 Zyprexa LW Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Small for Dates Baby
6155656 5130132 11/24/2004 10/13/2006 Zyprexa LW Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Small for Dates Baby
6158477 5139922 10/31/2006 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6158492 5139932 10/31/2006 Zyprexa MD Drug Exposure During Pregnancy, Heart Disease Congenital
6158498 5139938 10/31/2006 Zyprexa MD Drug Exposure During Pregnancy, Heart Disease Congenital
6165161 5140127 07/09/2003 10/24/2006 07/09/2003 Zyprexa LW Death Neonatal, Drug Exposure During Pregnancy
M 6165616 5148162 10/01/2006 11/10/2006 Zyprexa MD Arrhythmia Neonatal, Drug Exposure During Pregnancy
F 6165617 5148163 11/10/2006 Zyprexa MD Drug Exposure During Pregnancy, Postpartum Disorder
6167418 5150366 09/14/1994 11/14/2006 Zyprexa CN Drug Exposure During Pregnancy, Small for Dates Baby
F 6168917 5152022 11/16/2006 Olanzapine MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypoglycaemia, Premature Baby, Small for Dates Baby, Supernumerary Nipple
6170538 5153816 11/20/2006 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy, Talipes, Urinary Tract Malformation
F 6170538 5629305 02/18/2008 Zyprexa MD Drug Exposure During Pregnancy, Urinary Tract Malformation
F 6173327 5157083 01/01/2006 11/27/2006 Zyprexa CN Bipolar Disorder Anxiety, Arrhythmia, Drug Exposure During Pregnancy, Infection, Insomnia, Neuroleptic Malignant Syndrome, Pneumonia, Pulmonary Embolism, Pyrexia, Thrombosis, Urinary Bladder Haemorrhage
F 6183261 5169905 01/09/2006 12/12/2006 Zyprexa CN Drug Exposure During Pregnancy, Small for Dates Baby
F 6206284 5195565 01/01/2006 01/02/2007 Zyprexa MD Abortion Spontaneous, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6226499 5223765 01/30/2007 Zyprexa MD Mania Drug Exposure During Pregnancy, Psychotic Disorder
F 6226499 5250763 02/28/2007 Zyprexa MD Psychotic Disorder Drug Exposure During Pregnancy
M 6240548 5240274 02/19/2007 07/04/2006 Zyprexa MD Schizophrenia Chromosome Abnormality, Cri Du Chat Syndrome, Drug Exposure During Pregnancy, Premature Baby, Trisomy 18
6243037 5243933 02/22/2007 Zyprexa MD Drug Exposure During Pregnancy, Macrostomia, Polyhydramnios
6243037 5253529 03/01/2007 Zyprexa MD Drug Exposure During Pregnancy, Macrostomia
6243037 5282794 04/02/2007 Zyprexa MD Drug Exposure During Pregnancy, Macrosomia
F 6252985 5254800 03/05/2007 Zyprexa MD Schizoaffective Disorder Drug Exposure During Pregnancy, Haemorrhage
F 6258126 5260889 11/08/2005 03/09/2007 Zyprexa CN Drug Exposure During Pregnancy, Small for Dates Baby
F 6264239 5268123 01/01/2006 03/19/2007 Zyprexa MD Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Premature Baby
F 6264248 5268134 01/01/2006 03/19/2007 Zyprexa MD Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Premature Baby
6265253 5269455 03/20/2007 Olanzapine MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome, Hypertonia, Hypoglycaemia Neonatal, Inappropriate Antidiuretic Hormone Secretion, Posture Abnormal, Streptococcal Sepsis
6265253 5343569 06/04/2007 Olanzapine MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome, Hypertonia Neonatal, Hypoglycaemia Neonatal, Inappropriate Antidiuretic Hormone Secretion, Posture Abnormal, Streptococcal Sepsis
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6266257 5270681 03/21/2007 Zyprexa MD Neonatal Diabetes Mellitus, Transmission of Drug Via Semen
F 6271454 5276597 06/17/2005 03/27/2007 Zyprexa CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Small for Dates Baby
6271458 5276603 10/01/2006 03/27/2007 Zyprexa MD Drug Exposure During Pregnancy, Foetal Disorder
6271458 5278223 10/01/2006 03/28/2007 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy
6271458 5315582 10/01/2006 05/03/2007 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy
6311428 5324175 01/01/2007 05/14/2007 01/01/2007 Zyprexa MD Chromosome Abnormality, Drug Exposure During Pregnancy
F 6322335 5337986 05/01/2007 05/30/2007 Zyprexa MD Dehydration, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
F 6322335 5395076 05/01/2007 07/24/2007 Zyprexa MD Dehydration, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
F 6322335 5422442 05/01/2007 08/22/2007 Zyprexa MD Dehydration, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
F 6322335 5456676 05/01/2007 09/18/2007 Zyprexa MD Dehydration, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Respiratory Disorder Neonatal, Somnolence Neonatal, Vomiting Neonatal
F 6322337 5337988 01/01/2007 05/30/2007 Zyprexa MD Drug Exposure During Pregnancy, Embolism
6325341 5343568 06/04/2007 Olanzapine MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome, Hypertonia Neonatal, Hypoglycaemia Neonatal, Inappropriate Antidiuretic Hormone Secretion, Posture Abnormal, Streptococcal Sepsis
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6342774 5370553 06/26/2007 Zyprexa CN Chromosome Abnormality, Drug Exposure During Pregnancy
F 6357202 5358103 05/30/2007 Zyprexa LW Diabetes Mellitus, Diabetic Coma, Diabetic Ketoacidosis, Hyperglycaemia, Pancreatitis
F 6364001 5393693 07/23/2007 Zyprexa MD Delusional Disorder, Persecutory Type Antepartum Haemorrhage, Drug Exposure During Pregnancy
F 6372237 5402006 07/31/2007 Zyprexa MD Depression Drug Exposure During Pregnancy, Dwarfism, Foetal Growth Retardation, Small for Dates Baby
6372571 5402249 08/01/2006 08/01/2007 Zyprexa MD Brachial Plexus Injury, Drug Exposure During Pregnancy
6375627 5405791 01/01/2006 08/06/2007 Zyprexa MD Acidosis, Drug Exposure During Pregnancy, Haemoglobin Decreased
6376636 5406820 01/01/2007 08/07/2007 Zyprexa MD Drug Exposure During Pregnancy, Talipes
F 6376638 5460568 10/26/2006 09/19/2007 Zyprexa MD Bipolar Disorder Acidosis, Cytogenetic Abnormality, Drug Exposure During Pregnancy, Foetal Growth Retardation, Gastrooesophageal Reflux Disease, Haemoglobin Decreased
F 6376638 5479177 10/26/2006 10/08/2007 Zyprexa MD Bipolar Disorder Acidosis, Cytogenetic Abnormality, Drug Exposure During Pregnancy, Foetal Growth Retardation, Gastrooesophageal Reflux Disease, Haemoglobin Decreased
6377054 5407287 07/10/2007 08/07/2007 Zyprexa MD Dystonia
6377054 5430932 07/10/2007 08/30/2007 Zyprexa MD Drug Exposure During Pregnancy, Dystonia
6377054 5583942 07/09/2007 01/08/2008 Zyprexa MD Obsessive-Compulsive Disorder Apgar Score Low, Drug Exposure During Pregnancy, Dystonia, Hyporeflexia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6386327 5419093 08/20/2007 Zyprexa MD Schizophrenia Atrial Septal Defect, Drug Exposure During Pregnancy
6386336 5419105 10/15/2006 08/20/2007 Zyprexa MD Personality Disorder Drug Exposure During Pregnancy, Heart Disease Congenital
F 6391723 5426233 01/01/1997 08/27/2007 01/01/1997 Zyprexa MD Stillbirth
6392257 5427177 08/28/2007 Olanzapine MD Drug Exposure During Pregnancy, Drug Screen False Positive, Drug Withdrawal Syndrome Neonatal, Meconium Stain, Neonatal Respiratory Failure
F 6404770 5441463 01/01/2007 09/04/2007 Zyprexa MD Drug Exposure During Pregnancy, Hospitalisation
F 6404770 5448385 01/01/2007 09/11/2007 Zyprexa MD Hospitalisation
M 6409426 5447233 09/10/2007 Zyprexa MD Drug Exposure During Pregnancy, Porencephaly
6409426 5468036 09/26/2007 Zyprexa MD Psychotic Disorder Drug Exposure During Pregnancy, Porencephaly
6409426 5479178 10/08/2007 Zyprexa MD Psychotic Disorder Drug Exposure During Pregnancy, Porencephaly
6427460 5467857 09/26/2007 Zyprexa MD Drug Exposure During Pregnancy, Premature Baby
F 6446790 5492800 10/23/2007 Zyprexa MD Autosomal Chromosome Anomaly, Drug Exposure During Pregnancy
6455882 5502698 03/19/2006 10/31/2007 Zyprexa MD Drug Exposure During Pregnancy, Escherichia Sepsis, Hypotonia Neonatal, Meconium Ileus, Necrotising Enterocolitis Neonatal, Neonatal Respiratory Distress Syndrome
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6455882 5513830 03/19/2006 11/13/2007 Zyprexa MD Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome
6464895 5513825 08/02/2006 11/13/2007 Zyprexa CN Brief Psychotic Disorder With Marked Stressors Drug Exposure During Pregnancy, Escherichia Sepsis, Haematoma, Hypotonia Neonatal, Meconium Ileus, Necrotising Enterocolitis Neonatal, Oedema, Urine Sodium Increased, Weight Decrease Neonatal
F 6466675 5515795 10/01/2006 11/14/2007 Zyprexa MD Schizophrenia Brachial Plexopathy, Drug Exposure During Pregnancy
6473977 5524625 11/23/2007 Zyprexa MD Schizophrenia Atrioventricular Septal Defect, Drug Exposure During Pregnancy, Talipes
6475946 5527509 11/28/2007 Zyprexa MD Cerebral Cyst, Drug Exposure During Pregnancy
6512896 5571513 07/02/2007 12/21/2007 Olanzapine MD Mania Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
6512896 5656195 07/02/2007 03/08/2008 Olanzapine MD Mania Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
F 6526036 5542394 01/01/2007 11/29/2007 Zyprexa MD Bipolar Disorder Drug Exposure During Pregnancy, Gestational Diabetes, Weight Increased
F 6531181 5596996 09/26/2007 01/21/2008 Zyprexa MD Insomnia Breast Cancer, Drug Exposure During Pregnancy
6532142 5598711 01/01/2007 01/22/2008 Olanzapine MD Schizophrenia Anotia, Drug Exposure During Pregnancy, Hypospadias
6532142 5656194 01/01/2007 03/08/2008 Olanzapine MD Schizophrenia Anotia, Drug Exposure During Pregnancy, Hypospadias
F 6539974 5609237 07/25/2007 01/31/2008 Zyprexa CN Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Foetal Growth Retardation, Foetal Heart Rate Disorder, Hepatic Function Abnormal, Neonatal Respiratory Distress Syndrome, Premature Baby
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6542276 5612271 01/18/2008 02/04/2008 Olanzapine MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
M 6542276 5620027 01/17/2008 02/08/2008 Olanzapine MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder, Premature Baby, Respiratory Disorder Neonatal
M 6542276 5636765 01/17/2008 02/25/2008 Olanzapine MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Premature Baby, Sluggishness
6542276 5676854 01/17/2008 03/24/2008 Zyprexa MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Premature Baby, Sluggishness
6548313 5620024 12/25/2007 02/08/2008 Zyprexa MD Personality Disorder Cephalo-Pelvic Disproportion, Cleft Palate, Drug Exposure During Pregnancy
M 6548313 5638625 12/25/2007 02/26/2008 Zyprexa MD Personality Disorder Cephalo-Pelvic Disproportion, Cleft Palate, Drug Exposure During Pregnancy
F 6564664 5642702 02/28/2008 Zyprexa MD Depression Drug Exposure During Pregnancy, Panic Attack
F 6585841 5669269 10/01/2007 03/17/2008 Zyprexa MD Schizophrenia, Paranoid Type Anaemia, Drug Exposure During Pregnancy, Overdose
F 6585843 5669273 07/01/2007 03/17/2008 Zyprexa MD Schizophrenia Complication of Pregnancy, Drug Exposure During Pregnancy
0 Months M 5727835 4562723 08/01/2004 01/21/2005 Zyprexa MD Drug Exposure During Pregnancy, Hypospadias, Hypotonia Neonatal
F 6531181 5703878 09/26/2007 04/14/2008 Zyprexa MD Insomnia Breast Cancer, Caesarean Section, Drug Exposure During Pregnancy
F 6531181 5724672 09/26/2007 05/01/2008 Zyprexa MD Schizophrenia, Paranoid Type Breast Cancer, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6539974 5695700 07/25/2007 04/07/2008 Zyprexa CN Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Foetal Growth Retardation, Foetal Heart Rate Disorder, Hepatic Function Abnormal, Neonatal Respiratory Distress Syndrome, Premature Baby
6542276 5723229 01/17/2008 04/30/2008 Zyprexa MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Premature Baby, Sluggishness
F 6564664 5719205 04/28/2008 Zyprexa MD Depression Caesarean Section, Drug Exposure During Pregnancy, Panic Attack, Premature Labour
6607335 5695702 04/07/2008 Zyprexa MD Borderline Personality Disorder Bone Tuberculosis, Drug Exposure During Pregnancy
6613741 5703874 04/14/2008 Zyprexa MD Congenital Diaphragmatic Hernia, Drug Exposure During Pregnancy
6613741 5743512 05/20/2008 Zyprexa MD Mental Disorder Congenital Diaphragmatic Hernia, Drug Exposure During Pregnancy
6613741 5748996 05/27/2008 Zyprexa MD Mental Disorder Congenital Diaphragmatic Hernia, Drug Exposure During Pregnancy
6613743 5703879 09/24/2007 04/14/2008 Zyprexa MD Schizophrenia Drug Exposure During Pregnancy, Premature Baby
6613743 5707294 09/24/2007 04/16/2008 Zyprexa MD Schizophrenia Drug Exposure During Pregnancy, Premature Baby
6613743 5726992 09/24/2007 05/05/2008 Zyprexa MD Schizophrenia Drug Exposure During Pregnancy, Premature Baby
F 6619058 5710743 01/01/2000 04/21/2008 Zyprexa CN Blood Cholesterol Increased, Blood Triglycerides Increased, Cardiac Failure Congestive, Cardiomyopathy, Cholelithiasis, Diabetes Mellitus, Drug Exposure During Pregnancy, Gestational Diabetes, Hyperglycaemia, Metabolic Syndrome, Myocardial Ischaemia, Obesity
6630158 5724678 05/01/2008 Zyprexa MD Schizophrenia, Disorganised Type Congenital Hand Malformation, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6634252 5730043 08/01/2007 05/07/2008 Zyprexa MD Mental Disorder Cerebral Ventricle Dilatation, Drug Exposure During Pregnancy
6634253 5730044 08/01/2007 05/07/2008 Zyprexa MD Mental Disorder Bradycardia Foetal, Drug Exposure During Pregnancy, Premature Baby
6635269 5731433 05/08/2008 Zyprexa MD Mental Disorder Diaphragmatic Hernia, Drug Exposure During Pregnancy
6635269 5745001 05/21/2008 Zyprexa MD Mental Disorder Diaphragmatic Hernia, Drug Exposure During Pregnancy
6635269 5773172 06/16/2008 Zyprexa MD Mental Disorder Diaphragmatic Hernia, Drug Exposure During Pregnancy
6635270 5731434 01/01/2008 05/08/2008 01/01/2008 Zyprexa MD Mental Disorder Diaphragmatic Hernia, Drug Exposure During Pregnancy, Neonatal Disorder
6644089 5743513 05/20/2008 Zyprexa MD Drug Exposure During Pregnancy, Premature Baby, Therapeutic Agent Toxicity
6644093 5743518 05/20/2008 Zyprexa MD Convulsion, Drug Exposure During Pregnancy, Premature Baby, Pulmonary Hypertension, Therapeutic Agent Toxicity
F 6654607 5754973 09/01/2006 06/02/2008 Zyprexa MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy
F 6656807 5758287 04/01/2008 06/04/2008 Zyprexa CN Psychotic Disorder Drug Exposure During Pregnancy, Stress at Work, Uterine Haemorrhage
F 6668287 5773351 01/01/2004 06/16/2008 Zyprexa CN Mental Disorder Drug Exposure Before Pregnancy, Premature Baby
F 6668288 5773352 01/01/2000 06/16/2008 Zyprexa CN Mental Disorder Drug Exposure During Pregnancy, Premature Baby
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day 3932072 4385678 03/03/2003 06/23/2004 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dystonia, Gastrooesophageal Reflux Disease, Growth Retardation, Neonatal Disorder, Psychomotor Retardation, Tremor
1 Day F 4040106 4294495 01/06/2004 02/11/2004 Zyprexa MD Anomaly of External Ear Congenital, Caesarean Section, Facial Dysmorphism, Foetal Alcohol Syndrome, Maternal Drugs Affecting Foetus, Microcephaly, Paralysis, Spine Malformation
1 Day M 4054840 4300562 11/10/2003 02/18/2004 11/10/2003 Zyprexa MD Caesarean Section, Hypertelorism of Orbit, Intra-Uterine Death, Maternal Drugs Affecting Foetus, Placental Insufficiency, Umbilical Cord Abnormality
1 Day M 4089256 4315330 10/25/2003 03/09/2004 Zyprexa MD Apgar Score Low, Cleft Lip and Palate, Maternal Drugs Affecting Foetus
1 Day F 4092347 4294349 10/16/2003 02/11/2004 Zyprexa OT Double Ureter, Maternal Drugs Affecting Foetus
1 Day M 4156620 4377244 06/08/2004 06/14/2004 Zyprexa MD Bipolar Disorder Drug Exposure During Pregnancy, Neonatal Disorder, Sedation
1 Day F 4168234 4391611 01/13/2004 07/01/2004 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Neonatal Tachypnoea
1 Day 4194655 4426863 07/20/2004 08/11/2004 Zyprexa MD Blood Amino Acid Level Decreased, Circulatory Failure Neonatal, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Haematemesis, Meconium Stain, Neonatal Disorder, Vomiting Neonatal
1 Day M 4194655 4448576 07/19/2004 09/09/2004 Zyprexa MD Abdominal Distension, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Haematemesis, Meconium Stain, Neonatal Disorder
1 Day 4195548 4426874 07/22/2004 08/11/2004 Olanzapine OT Amniocentesis Abnormal, Blood Creatine Phosphokinase Increased, Drug Exposure During Pregnancy, Hyperaesthesia, Hypoglycaemia Neonatal, Laboratory Test Abnormal, Large for Dates Baby, Neonatal Disorder, Neonatal Pneumonia, Tremor Neonatal
1 Day M 4211252 4448943 12/18/1997 09/09/2004 Zyprexa Acrochordon, Drug Exposure During Pregnancy, Premature Baby
1 Day F 4218971 4457524 07/16/2004 09/22/2004 Zyprexa Drug Exposure During Pregnancy, Neonatal Aspiration
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day 5661397 4489020 09/10/2004 10/26/2004 Zyprexa MD Drug Exposure During Pregnancy, Polydactyly
1 Day F 5739177 4572060 09/23/2004 02/02/2005 Zyprexa OT Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Feeding Problem In Child
1 Day F 5739177 4658387 09/23/2004 05/09/2005 Zyprexa OT Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Neonatal Disorder
1 Day F 5739177 4853092 09/23/2004 12/12/2005 Zyprexa OT Apgar Score Low, Caesarean Section, Developmental Delay, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Speech Disorder Developmental, Weight Gain Poor
1 Day 5769841 4618342 03/24/2005 Zyprexa MD Cleft Lip, Congenital Anomaly, Drug Exposure During Pregnancy, Encephalocele, Multiple Congenital Abnormalities, Neural Tube Defect
1 Day F 5781756 4638193 03/04/2005 04/18/2005 Zyprexa MD Drug Exposure During Pregnancy, Dyskinesia Neonatal, Feeding Problem In Newborn, Hypotonia Neonatal
1 Day F 5781756 4684547 03/04/2005 05/31/2005 Zyprexa MD Dyskinesia Neonatal, Feeding Problem In Newborn, Hypotonia Neonatal
1 Day F 5781756 4713680 03/04/2005 07/13/2005 Zyprexa OT Cyanosis Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Eyelid Disorder, Feeding Disorder Neonatal, Floppy Infant, Head Lag, Hypotonia Neonatal, Neonatal Apnoeic Attack, Neonatal Disorder, Vascular Skin Disorder
1 Day M 5782758 4638228 03/25/2005 04/15/2005 Zyprexa OT Drug Exposure During Pregnancy, Neonatal Respiratory Depression
1 Day M 5782758 4697592 03/25/2005 06/21/2005 Zyprexa OT Drug Exposure During Pregnancy, Meconium In Amniotic Fluid, Neonatal Respiratory Distress Syndrome
1 Day M 5802390 4662638 10/27/2004 05/12/2005 Zyprexa MD Drug Exposure During Pregnancy, Renal Agenesis
1 Day M 5802390 4681874 10/27/2004 06/02/2005 Zyprexa MD Drug Exposure During Pregnancy, Renal Agenesis, Solitary Kidney
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day M 5803399 4665076 01/03/2005 05/17/2005 01/03/2005 Zyprexa MD Cardiomegaly, Death Neonatal, Drug Exposure During Pregnancy, Foetal Macrosomia, Neonatal Disorder
1 Day 5834272 4854430 12/13/2005 Zyprexa MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Haemoglobin Decreased, Neonatal Infection, Neonatal Pneumonia, Polycythaemia, Tension
1 Day F 5845394 4716477 07/13/2005 Olanzapine MD Apgar Score Low, Drug Exposure During Pregnancy, Premature Baby
1 Day F 5845394 4738626 08/03/2005 Olanzapine MD Apgar Score Low, Drug Exposure During Pregnancy, Premature Labour
1 Day F 5892732 4784419 03/04/2004 09/28/2005 Zyprexa OT Alcohol Withdrawal Syndrome, Alcoholism, Anxiety, Blood Glucose Increased, Caesarean Section, Diabetes Mellitus Non-Insulin-dependent, Gestational Diabetes, Malaise, Nausea, Oedema Peripheral, Pre-Eclampsia, Pregnancy Induced Hypertension, Protein Urine Present, Vomiting
1 Day F 5907197 4822116 06/30/2005 11/03/2005 Olanzapine Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Poor Sucking Reflex
1 Day F 5907197 4853517 12/12/2005 Olanzapine Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Oral Candidiasis, Poor Sucking Reflex, Somnolence Neonatal
1 Day F 5915929 4809699 03/03/2004 10/21/2005 Zyprexa Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Lethargy, Neonatal Disorder, Polycythaemia
1 Day F 5921771 4822317 10/04/2005 11/03/2005 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Respiratory Disorder Neonatal
1 Day F 5921771 5141735 10/04/2005 10/27/2006 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Neonatal Disorder, Neonatal Respiratory Depression, Premature Baby
1 Day F 5959051 4870291 12/04/2005 12/28/2005 Zyprexa PH Haemangioma Congenital, Transmission of Drug Via Semen
1 Day 5976864 4895608 01/01/1997 01/25/2006 01/01/1997 Zyprexa MD Drug Exposure During Pregnancy, Drug Toxicity
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day M 5997905 4918368 01/11/2006 02/14/2006 Zyprexa MD Obsessive-Compulsive Personality Disorder Bradycardia Foetal, Bradypnoea, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Forceps Delivery, Hypotonia Neonatal, Hypoventilation Neonatal, Neonatal Disorder, Sedation, Tremor Neonatal
1 Day 5997905 4936714 11/11/2005 03/02/2006 Zyprexa MD Obsessive-Compulsive Personality Disorder Bradycardia Neonatal, Bradypnoea, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Foetal Distress Syndrome, Forceps Delivery, Hypotonia Neonatal, Hypoventilation Neonatal, Meconium In Amniotic Fluid, Neonatal Disorder, Neonatal Hypoxia, Sedation, Tremor Neonatal
1 Day 5997905 4936902 11/11/2005 03/02/2006 Zyprexa MD Obsessive-Compulsive Personality Disorder Apgar Score Low, Bradycardia Foetal, Bradypnoea, Chorea, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Foetal Distress Syndrome, Hypokinesia Neonatal, Hypotonia Neonatal, Hypoventilation Neonatal, Masked Facies, Meconium In Amniotic Fluid, Neonatal Disorder, Respiratory Disorder Neonatal, Somnolence Neonatal, Tremor Neonatal
1 Day 5997905 4990741 11/11/2005 04/28/2006 Zyprexa Obsessive-Compulsive Personality Disorder Bradycardia Foetal, Bradypnoea, Chorea, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Foetal Distress Syndrome, Forceps Delivery, Hypokinesia Neonatal, Hypotonia Neonatal, Hypoventilation Neonatal, Meconium In Amniotic Fluid, Somnolence Neonatal, Tremor Neonatal
1 Day F 6036548 4979326 01/01/2004 04/18/2006 Zyprexa OT Drug Exposure During Pregnancy, Pilonidal Cyst Congenital, Transmission of Drug Via Semen
1 Day F 6045428 4891820 10/04/2005 01/23/2006 Zyprexa PH Congenital Anomaly, Haemangioma of Skin, Transmission of Drug Via Semen
1 Day F 6093118 5042947 01/01/2005 06/27/2006 Zyprexa MD Schizophrenia Delirium, Drug Abuser, Drug Exposure During Pregnancy, Refusal of Treatment By Patient, Trisomy 21
1 Day 6126850 5096388 08/30/2006 Zyprexa MD Anal Stenosis, Chromosome Abnormality, Congenital Anomaly, Drug Exposure During Pregnancy, Platelet Count Decreased, Preternatural Anus, Skull Malformation
1 Day 6126850 5106684 09/13/2006 Zyprexa MD Anal Stenosis, Chromosome Abnormality, Drug Exposure During Pregnancy, Platelet Count Decreased, Preternatural Anus, Skull Malformation
1 Day 6126850 5117718 09/26/2006 Zyprexa MD Anal Stenosis, Autosomal Chromosome Anomaly, Congenital Anomaly, Drug Exposure During Pregnancy, Platelet Count Decreased, Preternatural Anus, Skull Malformation
1 Day F 6126850 5123418 10/05/2006 Zyprexa MD Anal Stenosis, Autosomal Chromosome Anomaly, Congenital Anomaly, Drug Exposure During Pregnancy, Low Set Ears, Preternatural Anus, Skull Malformation, Thrombocytopenia
1 Day 6145584 5120627 07/01/2006 10/02/2006 Zyprexa MD Agitation Neonatal, Drug Exposure During Pregnancy, Somnolence Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day 6167107 5141849 03/19/2006 10/27/2006 Zyprexa Drug Exposure During Pregnancy, Hypotonia Neonatal, Maternal Condition Affecting Foetus, Neonatal Respiratory Distress Syndrome
1 Day 6187226 5174301 12/14/2006 Olanzapine MD Drug Exposure During Pregnancy, Finger Deformity
1 Day 6187226 5207962 01/15/2007 Olanzapine MD Congenital Hand Malformation, Drug Exposure During Pregnancy
1 Day F 6215113 5207965 10/10/2006 01/15/2007 Zyprexa MD Drug Exposure During Pregnancy, Neonatal Asphyxia, Neonatal Infection
1 Day 6233613 5233520 11/08/2005 02/08/2007 Olanzapine MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Malaise
1 Day 6233613 5238322 11/08/2005 02/15/2007 Olanzapine MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Malaise
1 Day 6233613 5245453 11/08/2005 02/23/2007 Olanzapine MD Crying, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Irritability, Malaise, Somnolence, Weight Decreased
1 Day 6233613 5290306 11/08/2005 04/09/2007 Olanzapine MD Crying, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Irritability, Malaise, Somnolence, Weight Decreased
1 Day 6233613 5314434 11/08/2005 05/02/2007 Olanzapine MD Crying, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Irritability, Malaise, Somnolence, Weight Decreased
1 Day F 6271451 5276592 07/06/2006 03/27/2007 Zyprexa MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal
1 Day F 6330579 5352839 11/02/2006 06/11/2007 Zyprexa MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
1 Day 6341704 5369228 05/11/2007 06/25/2007 Zyprexa MD Athetosis, Drug Exposure During Pregnancy, Hypertonia Neonatal, Muscle Contractions Involuntary
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day 6341753 5369287 01/01/2006 06/25/2007 Zyprexa MD Atrial Septal Defect, Drug Exposure During Pregnancy
1 Day F 6341753 5369310 01/01/2006 06/25/2007 Zyprexa MD Atrial Septal Defect, Drug Exposure During Pregnancy
1 Day F 6341753 5376387 01/01/2006 07/02/2007 Zyprexa MD Atrial Septal Defect, Drug Exposure During Pregnancy
1 Day F 6353085 5382491 05/09/2007 07/10/2007 Zyprexa MD Drug Exposure During Pregnancy, Patent Ductus Arteriosus
1 Day F 6365370 5395074 01/01/2006 07/24/2007 Zyprexa MD Drug Exposure During Pregnancy, Small for Dates Baby
1 Day F 6365370 5441468 01/01/2006 09/04/2007 Zyprexa MD Schizophrenia Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby
1 Day 6372571 5466764 08/01/2006 09/25/2007 Zyprexa MD Schizophrenia Brachial Plexus Injury, Drug Exposure During Pregnancy
2 Days M 4014415 4277679 06/14/2003 01/21/2004 Zyprexa MD Amniotic Cavity Infection, Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Tachypnoea, Premature Rupture of Membranes, Umbilical Hernia
2 Days M 4014415 4284730 06/14/2003 01/30/2004 Zyprexa MD C-Reactive Protein Increased, Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Infection, Respiratory Disorder Neonatal, Tachypnoea, Umbilical Hernia
2 Days F 6151156 5128928 05/01/2004 10/11/2006 Zyprexa LW Abasia, Apgar Score Low, Cardiac Murmur, Cerebral Haemorrhage Neonatal, Cerebral Infarction Foetal, Cerebrovascular Accident, Communication Disorder, Convulsion Neonatal, Cyanosis Neonatal, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Floppy Infant, Foetal Heart Rate Decreased, Foetal Movements Decreased, Hypertension Neonatal, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Intraventricular Haemorrhage Neonatal, Monoplegia, Neonatal Respiratory Distress Syndrome, Periventricular Leukomalacia, Premature Baby, Tremor Neonatal, Tricuspid Valve Incompetence, Ventricular Hypertrophy
2 Days F 6377959 5408200 05/01/2004 08/08/2007 Zyprexa CN Abasia, Apgar Score Low, Cardiac Murmur, Cerebral Haemorrhage, Cerebral Palsy, Cerebrovascular Accident, Communication Disorder, Convulsion Neonatal, Cyanosis, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Floppy Infant, Foetal Heart Rate Decreased, Foetal Movements Decreased, Hypertension Neonatal, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Infarction, Intraventricular Haemorrhage Neonatal, Monoplegia, Muscular Weakness, Neonatal Respiratory Distress Syndrome, Periventricular Leukomalacia, Premature Baby, Tremor Neonatal, Tricuspid Valve Incompetence, Ventricular Hypertrophy
4 Days F 5802451 4662627 03/18/2005 05/12/2005 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Gastrointestinal Disorder, Hypocalcaemia, Irritability, Neonatal Disorder, Premature Baby, Respiratory Disorder Neonatal, Transient Tachypnoea of the Newborn, Tremor Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Week 5922120 4822108 11/03/2005 Zyprexa MD Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Hip Dysplasia, Multiple Congenital Abnormalities, Neonatal Intestinal Obstruction, Vocal Cord Paralysis
8 Days F 5798070 4655820 11/28/2004 05/05/2005 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Premature Baby
16 Days 6135107 5104628 03/25/2006 09/11/2006 Zyprexa MD Drug Exposure During Pregnancy, Poor Sucking Reflex, Small for Dates Baby
3 Weeks F 6126852 5109714 04/24/2006 09/18/2006 05/15/2006 Zyprexa Zydis MD Caesarean Section, Death Neonatal, Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby
3 Weeks F 6173309 5120432 04/24/2006 10/02/2006 05/15/2006 Zyprexa Zydis Caesarean Section, Death Neonatal, Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby
3 Weeks F 6173309 5157062 01/01/2006 11/27/2006 05/15/2006 Zyprexa Zydis MD Drug Exposure During Pregnancy, Maternal Use of Illicit Drugs, Neonatal Respiratory Distress Syndrome, Pneumonectomy, Premature Baby, Small for Dates Baby, Staphylococcal Sepsis
2 Months 6295319 5306046 11/14/2006 04/24/2007 01/21/2007 Zyprexa MD Cardiac Arrest, Death, Drug Exposure During Pregnancy, Muscle Spasms, Neonatal Complications of Substance Abuse, Pulmonary Haemorrhage, Pulmonary Oedema, Sudden Infant Death Syndrome
66 Days F 6376638 5406822 10/26/2006 08/07/2007 Zyprexa MD Cytogenetic Abnormality, Drug Exposure During Pregnancy, Failure To Thrive
10 Weeks F 5744094 4578088 05/06/2004 02/09/2005 Olanzapine MD Bronchopneumonia, Diarrhoea, Drug Exposure During Pregnancy, General Physical Health Deterioration, Respiratory Tract Infection Viral, Salmonellosis, Sepsis
71 Days F 5744094 4765562 05/06/2004 09/06/2005 05/08/2004 Olanzapine MD Bronchopneumonia, Diarrhoea, Drug Exposure During Pregnancy, Respiratory Tract Infection, Sepsis, Viral Infection
12 Weeks 5696383 4522542 08/16/2004 12/07/2004 Zyprexa MD Drug Exposure During Pregnancy, Dysplasia
12 Weeks F 5696383 5052527 08/16/2004 07/11/2006 Zyprexa MD Caesarean Section, Drug Exposure During Pregnancy, Hip Dysplasia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
4 Months M 4183520 4411689 07/04/2003 07/29/2004 Zyprexa CN Bipolar Disorder Drug Exposure During Pregnancy, Nystagmus, Optic Nerve Hypoplasia, Visual Acuity Reduced
21 Weeks F 5652288 4476939 09/02/2004 10/13/2004 Olanzapine MD Convulsion, Drug Exposure During Pregnancy
21 Weeks F 5652288 4530769 09/02/2004 12/16/2004 Olanzapine OT Convulsion, Drug Exposure During Pregnancy, Dyskinesia
22 Weeks M 6050660 5123410 10/05/2006 Olanzapine PH Abortion Spontaneous, Chromosome Abnormality, Congenital Cardiovascular Anomaly, Congenital Cyst, Congenital Foot Malformation, Drug Exposure During Pregnancy, Kidney Malformation
12 Months F 6141281 5113291 11/08/2005 09/20/2006 Zyprexa LW Drug Exposure During Pregnancy, Small for Dates Baby
1 Year 6145584 5129128 07/04/2006 10/11/2006 Zyprexa MD Agitation Neonatal, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Hypoventilation Neonatal, Neonatal Respiratory Distress Syndrome, Somnolence Neonatal
18 Years F 6215202 5208173 01/15/2007 Zyprexa MD Hallucination Caesarean Section, Drug Abuser, Drug Exposure During Pregnancy, Prolonged Labour
18 Years F 5997681 4935825 05/26/2000 03/02/2006 Zyprexa LW Bipolar Disorder Bloody Discharge, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Oligomenorrhoea, Vaginal Haemorrhage, Vomiting
18 Years F 5997681 4951515 05/26/2000 03/17/2006 Zyprexa LW Bipolar Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Vaginal Haemorrhage, Vomiting
19 Years F 6359739 5357450 01/01/2004 05/30/2007 Zyprexa LW Depression Diabetes Mellitus, Drug Exposure During Pregnancy, Gestational Diabetes
21 Years F 6170460 5629308 04/26/2006 02/18/2008 Zyprexa MD Bipolar Disorder Drug Exposure During Pregnancy
21 Years F 6359260 5358002 03/01/2006 05/30/2007 Zyprexa LW Depression Drug Exposure During Pregnancy, Gestational Diabetes
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
21 Years F 6170460 5153753 04/26/2006 11/20/2006 Zyprexa MD Bipolar Disorder Drug Exposure During Pregnancy
22 Years F 4095199 4300707 10/10/2003 02/18/2004 Zyprexa MD Acute Psychosis, Bipolar Disorder Abdominal Pain, Acute Psychosis, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Hypertelorism of Orbit, Intra-Uterine Death, Maternal Drugs Affecting Foetus, Placental Insufficiency, Smear Cervix Abnormal, Trisomy 21, Umbilical Cord Short
22 Years F 6121974 5090757 07/01/2006 08/23/2006 Zyprexa MD Bipolar Disorder Bipolar Disorder, Drug Exposure During Pregnancy, Haemorrhage
22 Years F 6121974 5118322 02/17/2005 09/26/2006 Zyprexa MD Bipolar Disorder Affect Lability, Aggression, Agitation, Anxiety, Bipolar Disorder, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Fall, Haemorrhage, Incoherent, Prescribed Overdose
22 Years F 6154331 5135520 02/17/2005 10/26/2006 Zyprexa MD Bipolar Disorder Affect Lability, Antepartum Haemorrhage, Anxiety, Asthma, Bipolar Disorder, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Haemorrhage, Incoherent, Prescribed Overdose, Psychotic Disorder
22 Years F 6154331 5140461 02/17/2005 10/24/2006 Zyprexa MD Bipolar Disorder Aggression, Antepartum Haemorrhage, Anxiety, Bipolar Disorder, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Prescribed Overdose
22 Years F 6154331 5303236 02/17/2005 04/20/2007 Zyprexa MD Bipolar Disorder Antepartum Haemorrhage, Asthma, Bipolar Disorder, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Prescribed Overdose
22 Years F 6355875 5356504 12/01/2001 05/30/2007 Zyprexa LW Abortion Spontaneous, Drug Exposure During Pregnancy, Gestational Diabetes, Hyperglycaemia
22 Years F 6359564 5358068 01/01/2000 05/30/2007 Zyprexa LW Bipolar Disorder Diabetes Mellitus, Diabetic Ketoacidosis, Drug Exposure During Pregnancy, Hyperglycaemia, Ketonuria, Obesity, Prescribed Overdose
23 Years F 5803393 4665074 07/01/2002 05/17/2005 Zyprexa MD Drug Exposure During Pregnancy, Foot Fracture, Grand Mal Convulsion, Pelvic Fracture, Suicide Attempt
23 Years F 6019220 4953908 11/09/2005 03/22/2006 Zyprexa MD Drug Exposure During Pregnancy, Insomnia, Nausea, Pain, Vaginal Disorder, Vomiting
23 Years F 6019220 4979487 11/09/2005 04/18/2006 Zyprexa MD Drug Exposure During Pregnancy, Insomnia, Nausea, Pain, Vomiting
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
23 Years F 6238696 5218436 01/01/2005 11/30/2006 Zyprexa LW Depression Drug Exposure During Pregnancy, Hypertension, Pancreatitis
23 Years F 6421050 5460567 02/20/2007 09/19/2007 Zyprexa MD Bipolar Disorder Antepartum Haemorrhage, Caesarean Section, Drug Exposure During Pregnancy, Premature Separation of Placenta
24 Years F 5834273 4704493 06/28/2005 Olanzapine MD Condition Aggravated, Drug Exposure During Pregnancy, Psychotic Disorder, Schizophrenia
24 Years F 6076157 5036281 06/01/2006 Zyprexa OT Bipolar Disorder Drug Exposure During Pregnancy
24 Years F 6136022 5106860 04/21/2006 09/13/2006 Zyprexa Zydis MD Schizophrenia (Paranoid Type) Caesarean Section, Drug Exposure During Pregnancy, Premature Labour, Uterine Haemorrhage
24 Years F 6136022 5117611 04/21/2006 09/26/2006 Zyprexa Zydis MD Schizophrenia (Paranoid Type) Antepartum Haemorrhage, Caesarean Section, Drug Exposure During Pregnancy, Premature Labour
24 Years F 6173307 5120577 04/01/2006 10/02/2006 Zyprexa Zydis MD Schizophrenia (Paranoid Type) Antepartum Haemorrhage, Caesarean Section, Drug Exposure During Pregnancy, Premature Labour, Premature Rupture of Membranes, Uterine Haemorrhage
24 Years F 6173307 5157060 04/01/2006 11/27/2006 Zyprexa Zydis MD Schizophrenia (Paranoid Type) Alcoholism, Antepartum Haemorrhage, Caesarean Section, Drug Exposure During Pregnancy, Maternal Use of Illicit Drugs, Premature Rupture of Membranes
24 Years F 6203032 5176851 12/12/2006 Zyprexa Bipolar Disorder Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy
24 Years F 6210279 5201041 09/01/2006 01/08/2007 Zyprexa MD Psychotic Disorder Drug Exposure During Pregnancy
24 Years F 6210279 5630215 09/01/2006 02/19/2008 Zyprexa MD Psychotic Disorder Drug Exposure During Pregnancy, Overdose
24 Years F 6251083 5252902 01/01/2006 03/01/2007 Zyprexa MD Schizophrenia Diet Refusal, Drug Exposure During Pregnancy, Psychotic Disorder, Sedation, Vomiting
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
25 Years F 6357202 5551494 01/01/2003 11/29/2007 Zyprexa LW Abortion Spontaneous, Diabetes Mellitus, Diabetic Coma, Diabetic Ketoacidosis, Hyperglycaemia, Metabolic Disorder, Pancreatitis
25 Years F 6399514 5436066 03/28/2006 08/31/2007 Zyprexa MD Abortion Spontaneous Complicated, Drug Exposure During Pregnancy, Premature Rupture of Membranes
26 Years F 6210308 5201076 01/01/2002 01/08/2007 Zyprexa CN Bipolar Disorder Acetonaemia, Blood Cholesterol Increased, Diabetes Complicating Pregnancy, Diabetes Mellitus, Diabetic Coma, Diabetic Ketoacidosis, Drug Exposure During Pregnancy, Hyperglycaemic Hyperosmolar Nonketotic Syndrome, Ketoacidosis, Ketonuria, Metabolic Disorder, Vision Blurred
26 Years F 6244719 5218166 03/01/2002 11/30/2006 Zyprexa LW Diabetes Mellitus Insulin-Dependent, Drug Exposure During Pregnancy, Gestational Diabetes, Glucose Urine Present, Hyperglycaemia, Hypoglycaemia, Ketonuria, Polydipsia, Polyuria, Vision Blurred, Weight Increased
27 Years F 6173333 5157088 01/19/2004 11/27/2006 Zyprexa CN Hallucination Diabetes Mellitus, Drug Exposure During Pregnancy, Myocardial Infarction
27 Years F 6259782 5263368 02/01/2002 03/13/2007 Zyprexa MD Schizophrenia, Paranoid Type Aggression, Depression, Drug Exposure During Pregnancy, Feeling Guilty, Foot Fracture, Grand Mal Convulsion, Marital Problem, Pelvic Fracture, Suicide Attempt
27 Years F 6355698 5356653 01/01/2003 05/30/2007 Zyprexa LW Depression Diabetes Mellitus, Drug Exposure During Pregnancy, Gestational Diabetes, Pancreatitis
28 Years F 5767315 4614039 07/28/2003 03/16/2005 Zyprexa MD Psychotic Disorder Asthenia, Caesarean Section, Delirium, Drug Exposure During Pregnancy, Pre-Eclampsia, Premature Labour, Pyrexia
28 Years F 5821692 4714091 10/03/2004 07/12/2005 Zyprexa MD Bipolar I Disorder Condition Aggravated, Depression, Drug Exposure During Pregnancy, Drug Toxicity, Intentional Misuse, Overdose, Premature Labour, Prescribed Overdose, Suicide Attempt, Thyroxine Increased
28 Years F 5948877 4853012 12/12/2005 Zyprexa OT Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Paranoia, Pre-Eclampsia, Refusal of Examination
28 Years F 6065924 5020156 06/02/2006 Zyprexa OT Bradycardia, Drug Exposure During Pregnancy, Drug Interaction, Tachyarrhythmia, Tachycardia
28 Years F 6105054 5071755 08/01/2006 Zyprexa MD Borderline Personality Disorder Caesarean Section, Drug Exposure During Pregnancy, Gangrene, Postpartum Haemorrhage, Toe Amputation
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
28 Years F 6240333 5216584 12/08/2005 11/30/2006 Zyprexa MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Pyrexia, Tachycardia
29 Years F 6206423 5195780 01/01/2001 01/02/2007 Zyprexa CN Anhedonia, Diabetes Mellitus, Diabetic Coma, Diabetic Ketoacidosis, Drug Exposure During Pregnancy, Haemorrhage, Pancreatitis
29 Years F 6243313 5244350 03/01/2006 02/22/2007 Zyprexa MD Bipolar Disorder Drug Exposure During Pregnancy, Vaginal Haemorrhage
29 Years F 6353656 5356297 01/01/2005 05/30/2007 Zyprexa CN Bipolar Disorder Drug Exposure During Pregnancy, Pancreatitis
29 Years F 4144242 4359521 01/01/2004 05/12/2004 Zyprexa Bipolar Disorder Complications of Maternal Exposure To Therapeutic Drugs, Induced Labour, Pre-Eclampsia, Red Blood Cell Count Increased
29 Years F 6005885 4936751 02/01/1998 03/02/2006 Zyprexa LW Blood Cholesterol Abnormal, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Haematochezia, Hallucinations (Mixed), Intentional Overdose, Oedema Peripheral, Pre-Eclampsia
29 Years F 6005885 5128258 02/01/1998 10/11/2006 Zyprexa LW Bipolar Disorder Blood Cholesterol Abnormal, Breech Delivery, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Haematemesis, Haematochezia, Hallucination (Auditory), Hallucination (Visual), Multiple Drug Overdose Intentional, Pre-Eclampsia, Rectal Haemorrhage
29 Years F 6161580 5143590 06/01/2006 11/03/2006 Zyprexa MD Schizoaffective Disorder Caesarean Section, Drug Exposure During Pregnancy, Hyperventilation, Uterine Hypotonus
29 Years F 6201813 5190882 01/01/1997 12/22/2006 Zyprexa CN Bipolar Disorder Blood Cholesterol Increased, Blood Triglycerides Increased, Diabetes Mellitus, Drug Exposure During Pregnancy, Gestational Diabetes, Hyperglycaemia, Pulmonary Embolism
30 Years F 5664594 4464701 04/09/2004 09/29/2004 Zyprexa MD Brief Psychotic Disorder With Postpartum Onset, Decreased Appetite, Delusion, Delusion of Reference, Depression, Drug Exposure During Pregnancy, Emotional Distress, Fatigue, Headache, Increased Appetite, Initial Insomnia, Morbid Thoughts, Paranoia, Persecutory Delusion, Self Esteem Decreased, Social Problem, Therapy Non-Responder, Victim of Abuse
30 Years F 5796543 4655727 01/01/2004 05/05/2005 Olanzapine MD Caesarean Section, Drug Exposure During Pregnancy, Premature Labour, Uterine Haematoma
30 Years F 5916494 4808310 12/27/2003 10/21/2005 Zyprexa MD Depression, Suicidal Ideation Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Leukopenia, Pre-Eclampsia, Premature Labour, Shift To the Left
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
30 Years F 6353894 5355426 01/01/1999 05/30/2007 Zyprexa LW Diabetes Mellitus, Drug Exposure During Pregnancy, Hepatitis, Hypertension, Metabolic Disorder, Pancreatitis, Vision Blurred
30 Years F 6355725 5356706 01/01/1999 05/30/2007 Zyprexa LW Depression Diabetes Mellitus, Drug Exposure During Pregnancy
30 Years F 6427559 5468034 09/26/2007 Zyprexa MD Abortion Spontaneous, Drug Exposure During Pregnancy, Intra-Uterine Death
31 Years F 6041901 4987715 03/01/2006 04/24/2006 Zyprexa MD Schizophrenia Abortion Threatened, Drug Exposure During Pregnancy, Excitability
31 Years F 6534779 5542206 04/01/2003 11/29/2007 Zyprexa LW Blood Cholesterol Increased, Diabetes Mellitus, Diabetic Coma, Diabetic Ketoacidosis, Drug Exposure During Pregnancy, Glycosuria, Hyperglycaemia, Pancreatitis
32 Years F 5786057 4642789 04/20/2005 Zyprexa MD Drug Exposure During Pregnancy, Intentional Misuse, Mental Disorder, Off Label Use
32 Years F 5803412 4665077 01/01/2004 05/17/2005 Zyprexa MD Drug Exposure During Pregnancy, Gestational Diabetes, Stillbirth
32 Years F 5925068 4824780 11/08/2005 Zyprexa MD Psychotic Disorder Abortion Induced, Drug Exposure During Pregnancy, Genital Haemorrhage, Heart Disease Congenital
32 Years F 5925068 4832759 11/17/2005 Zyprexa MD Psychotic Disorder Abortion Induced, Drug Exposure During Pregnancy, Genital Haemorrhage
32 Years F 6021419 4957175 04/01/2005 03/23/2006 Zyprexa MD Bipolar Disorder Disease Recurrence, Drug Exposure During Pregnancy, Gestational Diabetes, Postpartum Haemorrhage
32 Years F 6168914 5152018 11/16/2006 Zyprexa MD Schizoaffective Disorder Abortion Threatened, Drug Exposure During Pregnancy
32 Years F 6168914 5166763 07/01/2006 12/07/2006 Zyprexa MD Schizoaffective Disorder Abortion Threatened, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
32 Years F 6404772 5441465 01/01/2006 09/04/2007 Zyprexa MD Schizophrenia Drug Exposure During Pregnancy, Premature Labour, Threatened Labour
32 Years F 6659973 5762259 06/01/2007 06/09/2008 Zyprexa MD Psychotic Disorder Drug Exposure During Pregnancy, Psychotic Disorder
33 Years F 6255059 5358419 01/01/2003 05/30/2007 Zyprexa LW Depression Diabetes Mellitus, Drug Exposure During Pregnancy, Gestational Diabetes, Hypertension, Pancreatitis, Weight Increased
33 Years F 6353899 5355431 09/01/1999 05/30/2007 Zyprexa LW Drug Exposure During Pregnancy, Pancreatitis
33 Years F 4092872 4294145 10/22/2003 02/11/2004 Zyprexa MD Bipolar I Disorder, Mania Drug Exposure During Pregnancy, Metrorrhagia
33 Years F 4092872 4618843 10/22/2003 03/23/2005 Zyprexa MD Bipolar I Disorder, Mania, Psychotic Disorder Drug Exposure During Pregnancy, Metrorrhagia
33 Years F 5909358 4804896 10/17/2005 Olanzapine MD Psychotic Disorder Caesarean Section, Drug Exposure During Pregnancy, Pre-Eclampsia
33 Years F 5909358 4816175 07/01/2005 10/26/2005 Olanzapine MD Psychotic Disorder Albuminuria, Anaemia, Blood Uric Acid Increased, Caesarean Section, Drug Exposure During Pregnancy, Oedema Peripheral, Pre-Eclampsia
33 Years F 5915335 4808929 05/01/2004 10/21/2005 Zyprexa MD Schizophrenia Anaemia, Caesarean Section, Drug Exposure During Pregnancy, Glycosuria During Pregnancy, Leukocytosis, Urinary Tract Infection, Vulvovaginal Mycotic Infection, Weight Increased
33 Years F 5953893 4866880 01/01/2005 12/22/2005 Zyprexa MD Bipolar I Disorder Abortion Induced, Drug Exposure During Pregnancy, Pre-Eclampsia
33 Years F 6021728 4957670 01/01/2005 03/24/2006 Zyprexa CN Schizophrenia Drug Exposure During Pregnancy, Haemoglobin Decreased
33 Years F 6090545 5053500 04/20/2006 07/12/2006 Zyprexa MD Paranoia Carotid Artery Dissection, Cerebrovascular Accident, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
33 Years F 6136788 5106518 01/23/2006 09/12/2006 Zyprexa MD Psychotic Disorder Alcoholism, Caesarean Section, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Premature Labour
33 Years F 6136788 5109715 01/23/2006 09/18/2006 Zyprexa MD Psychotic Disorder Alcoholism, Caesarean Section, Drug Exposure During Pregnancy, Premature Labour
33 Years F 6154732 5130100 06/27/2006 10/13/2006 Zyprexa MD Insomnia Caesarean Section, Depression, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Insomnia
33 Years F 6154732 5141765 06/27/2006 10/27/2006 Zyprexa MD Depression Caesarean Section, Drug Exposure During Pregnancy
33 Years F 6255059 5217652 01/01/2003 11/30/2006 Zyprexa LW Depression Diabetes Mellitus, Hypertension, Pancreatitis, Weight Increased
34 Years F 6271450 5276591 03/27/2007 Zyprexa MD Postpartum Depression Drug Exposure During Pregnancy, Pyelonephritis, Renal Colic
34 Years F 6341705 5369229 06/23/2006 06/25/2007 Zyprexa MD Schizophrenia Drug Exposure During Pregnancy, Oesophagitis, Retained Placenta or Membranes, Streptococcal Infection, Thrombosis
34 Years F 6341705 5376951 06/23/2006 07/03/2007 Zyprexa MD Schizophrenia Drug Exposure During Pregnancy, Oesophagitis, Retained Placenta or Membranes, Streptococcal Infection, Thrombosis
34 Years F 4113049 4319170 12/02/2003 03/16/2004 Zyprexa MD Psychotic Disorder Complications of Maternal Exposure To Therapeutic Drugs, Fall, Overdose, Suicide Attempt
34 Years F 5749573 4588049 01/01/2005 02/16/2005 Olanzapine MD Bipolar Disorder Anaemia, Caesarean Section, Drug Exposure During Pregnancy, Hypothyroidism, Postpartum Disorder, Pre-Eclampsia, Serum Ferritin Decreased, Thrombocythaemia, White Blood Cell Count Decreased
34 Years F 5915178 4808538 01/01/2001 10/21/2005 Olanzapine CN Delirium, Hallucination (Auditory) Abortion Spontaneous, Amenorrhoea, Drug Exposure During Pregnancy, Dry Mouth, Intra-Uterine Death, Weight Increased, White Blood Cell Count Decreased
34 Years F 6635272 5731436 01/01/1997 05/08/2008 Zyprexa CN Mental Disorder Bedridden, Cerebrovascular Accident, Convulsion, Diabetes Mellitus, Dyspnoea, Gait Disturbance, Heart Rate Increased, Hemiparesis, Impaired Work Ability, Infertility, Myocardial Infarction, Overdose, Photosensitivity Reaction, Weight Increased, White Blood Cell Count Abnormal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
34 Years F 6635272 5773356 01/01/1997 06/16/2008 Zyprexa CN Mental Disorder Bedridden, Cerebrovascular Accident, Convulsion, Diabetes Mellitus, Drug Exposure During Pregnancy, Dyspnoea, Gait Disturbance, Heart Rate Increased, Hemiparesis, Impaired Work Ability, Infertility, Myocardial Infarction, Overdose, Photosensitivity Reaction, Weight Increased, White Blood Cell Count Abnormal
35 Years F 4122456 4332182 03/31/2004 Olanzapine MD Schizoaffective Disorder Completed Suicide, Complications of Maternal Exposure To Therapeutic Drugs
35 Years F 4122456 4426623 08/11/2004 Olanzapine MD Schizoaffective Disorder Completed Suicide, Drug Exposure During Pregnancy, Intentional Self-Injury, Multiple Drug Overdose, Therapeutic Agent Toxicity
35 Years F 4122456 4432746 08/20/2004 11/12/2003 Olanzapine MD Psychotic Disorder Abnormal Behaviour, Blood Alcohol Increased, Completed Suicide, Coronary Artery Atherosclerosis, Depression, Drug Exposure During Pregnancy, Drug Screen Positive, Drug Toxicity, Injury Asphyxiation, Multiple Drug Overdose Intentional, Pulmonary Congestion, Pulmonary Oedema, Skin Laceration, Sleep Disorder, Vascular Injury
35 Years F 4122456 4434186 08/25/2004 11/12/2003 Olanzapine MD Schizoaffective Disorder Completed Suicide, Coronary Artery Atherosclerosis, Depression, Drug Dependence, Drug Exposure During Pregnancy, Drug Toxicity, Overdose, Pharmaceutical Product Complaint, Pulmonary Congestion, Pulmonary Oedema, Wound
35 Years F 4143863 4359254 04/16/2004 05/12/2004 Zyprexa OT Bipolar Disorder Complications of Maternal Exposure To Therapeutic Drugs, Injury, Road Traffic Accident
35 Years F 4168346 4393299 07/01/2004 12/01/2000 Zyprexa MD Drug Exposure During Pregnancy, Intra-Uterine Death
35 Years F 4168346 4407596 07/21/2004 12/01/2000 Zyprexa MD Drug Exposure During Pregnancy, Intra-Uterine Death
35 Years F 6019223 4953916 12/27/2005 03/22/2006 Zyprexa MD Schizoaffective Disorder Drug Exposure During Pregnancy
35 Years F 6074156 5030066 01/01/2005 06/14/2006 Zyprexa OT Psychotic Disorder Anaemia, Drug Exposure During Pregnancy, Vacuum Extractor Delivery
35 Years F 6236535 5217663 07/01/2005 11/30/2006 Zyprexa CN Bipolar I Disorder Blood Glucose Increased, Drug Exposure During Pregnancy, Gestational Diabetes, Weight Increased
35 Years F 6349528 5378231 01/01/2007 07/05/2007 Zyprexa MD Bipolar Disorder Bipolar Disorder, Drug Exposure During Pregnancy, Overdose
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
35 Years F 6376641 5406826 01/01/2006 08/07/2007 Zyprexa MD Drug Exposure During Pregnancy, Premature Separation of Placenta
36 Years F 4071179 4272033 09/10/2003 01/13/2004 Olanzapine Bipolar Disorder, Psychotic Disorder Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus
36 Years F 5892284 4784777 02/26/2004 09/28/2005 Zyprexa OT Psychotic Disorder Alcoholism, Anxiety, Caesarean Section, Diabetes Mellitus Non-Insulin-dependent, Drug Exposure During Pregnancy, Gestational Diabetes, Malaise, Nausea, Pre-Eclampsia, Vomiting
36 Years F 6160127 5134195 10/19/2006 Zyprexa MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy
36 Years F 6198428 5186370 01/03/2006 12/20/2006 Zyprexa MD Borderline Personality Disorder Anaemia, Drug Exposure During Pregnancy, Epistaxis, Otorhinolaryngological Surgery
36 Years F 6198428 5207923 01/03/2006 01/15/2007 Zyprexa MD Borderline Personality Disorder Anaemia, Drug Exposure During Pregnancy, Epistaxis, Otorhinolaryngological Surgery
36 Years F 6378789 5358320 05/30/2007 Zyprexa MD Bipolar I Disorder Drug Exposure During Pregnancy, Paranoia
37 Years F 6244233 5217795 05/01/2005 11/30/2006 Zyprexa LW Blood Cholesterol Increased, Chest Pain, Diabetes Mellitus, Drug Exposure During Pregnancy, Hypertension, Metabolic Disorder, Obesity
37 Years F 6251084 5252903 01/01/2005 03/01/2007 Zyprexa CN Delusional Disorder, Persecutory Type Caesarean Section, Delusional Disorder, Persecutory Type, Drug Exposure During Pregnancy, Drug Ineffective, Extrapyramidal Disorder
37 Years F 6266259 5270683 01/01/2000 03/21/2007 Zyprexa CN Schizophrenia Diabetes Mellitus, Drug Exposure During Pregnancy, Gestational Diabetes, Hyperglycaemia, Toe Amputation
37 Years F 6345229 5373937 01/01/2007 06/28/2007 Zyprexa CN Abortion Spontaneous, Antepartum Haemorrhage, Drug Exposure During Pregnancy
37 Years F 5958998 4870742 06/01/2005 12/29/2005 Zyprexa MD Bipolar I Disorder Abortion Spontaneous, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
38 Years F 4070000 4444463 07/01/2004 09/02/2004 Zyprexa PH Schizophrenia Diabetes Mellitus, Drug Exposure During Pregnancy, Premature Labour, Psychotic Disorder
38 Years F 5663898 4493927 11/02/2004 Zyprexa MD Psychotic Disorder Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Pre-Eclampsia, Premature Baby, Weight Increased
38 Years F 5663898 4528094 11/29/2004 Zyprexa MD Psychotic Disorder Gestational Diabetes, Pre-Eclampsia, Weight Increased
38 Years F 5728663 4563807 06/01/2001 01/21/2005 Olanzapine MD Mental Disorder Abortion Spontaneous, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Cholesterol Increased, Bronchitis, Condition Aggravated, Diabetes Mellitus, Difficulty In Walking, Drug Exposure During Pregnancy, Fibrocystic Breast Disease, Gastrooesophageal Reflux Disease, Hallucination (Auditory), Headache, Hepatic Enzyme Increased, Low Density Lipoprotein Increased, Metrorrhagia, Nephrolithiasis, Plantar Fasciitis, Rash, Tenderness, Weight Increased
38 Years F 5860929 4738636 05/21/2005 08/03/2005 Zyprexa MD Schizophrenia Abortion Spontaneous, Drug Exposure During Pregnancy
38 Years F 6266248 5270658 11/10/2004 03/21/2007 Zyprexa MD Drug Exposure During Pregnancy, Suicide Attempt
38 Years F 6359563 5358067 03/01/2005 05/30/2007 Zyprexa LW Cardiac Failure Congestive, Chest Pain, Drug Exposure During Pregnancy, Gestational Diabetes, Hyperglycaemia, Hypertension
39 Years F 6545487 5616443 12/04/2007 02/07/2008 Zyprexa MD Depression Drug Exposure During Pregnancy
39 Years F 6646637 5746511 05/22/2008 Zyprexa MD Agitation, Confusional State, Delayed Recovery From Anaesthesia, Disorientation, Drug Exposure During Pregnancy, Obstructive Uropathy, Renal Impairment, Restlessness, Therapeutic Agent Toxicity
39 Years F 6668291 5773355 01/01/2004 06/16/2008 Zyprexa CN Mental Disorder Stillbirth
39 Years F 6426589 5466750 09/25/2007 Zyprexa MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy
39 Years F 6426589 5469307 09/27/2007 Zyprexa MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
41 Years F 6461341 5509725 01/01/2004 11/08/2007 Zyprexa CN Mental Disorder Confusional State, Drug Exposure During Pregnancy, Gait Disturbance, Heart Rate Irregular, Hypoaesthesia, Memory Impairment, Palpitations, Syncope
42 Years F 5931199 4833252 08/08/2005 11/17/2005 Zyprexa MD Schizoaffective Disorder Condition Aggravated, Drug Exposure During Pregnancy, Schizoaffective Disorder
42 Years F 5931199 4954773 08/08/2005 03/22/2006 Zyprexa MD Schizoaffective Disorder Condition Aggravated, Drug Exposure During Pregnancy, Schizoaffective Disorder
43 Years F 6061371 5016002 01/01/2005 05/25/2006 Zyprexa OT Major Depression Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Placenta Praevia Haemorrhage
45 Years F 5991106 4909001 11/27/2001 02/09/2006 Zyprexa LW Bipolar Disorder Back Pain, Diabetes Mellitus Non-Insulin-dependent, Dizziness, Gastric Ulcer Haemorrhage, Headache, Hypertriglyceridaemia, Nausea, Weight Increased
45 Years F 5991106 4919002 01/01/1999 02/16/2006 Zyprexa LW Bipolar Disorder Back Pain, Caesarean Section, Diabetes Mellitus Inadequate Control, Drug Exposure During Pregnancy, Gastric Ulcer Haemorrhage, Gestational Diabetes, Haematemesis, Hypertriglyceridaemia, Nausea, Weight Increased
45 Years F 5991106 4957282 01/01/1999 03/23/2006 Zyprexa LW Bipolar Disorder Caesarean Section, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Non-Insulin-dependent, Dizziness, Drug Exposure During Pregnancy, Fatigue, Gastric Ulcer Haemorrhage, Gestational Diabetes, Headache, Hypercholesterolaemia, Hypertriglyceridaemia, Weight Increased
19 Males 179 Females 277 Cases (Gender was not reported for 79 Cases) 403 Individual Safety Reports

This is a list of all Primary Suspect Drugs reported in the Detail Table

Olanzapine (olanzapine), Zyprexa (olanzapine), Zyprexa Zydis (olanzapine)

These are the Adverse Reactions culled from the Individual Safety Reports in the Detail Table

Abasia, Abdominal Distension, Abdominal Pain, Abnormal Behaviour, Abortion Induced, Abortion Spontaneous, Abortion Spontaneous Complicated, Abortion Threatened, Acetonaemia, Acidosis, Acrochordon, Acute Psychosis, Affect Lability, Aggression, Agitation, Agitation Neonatal, Alanine Aminotransferase Increased, Albuminuria, Alcohol Withdrawal Syndrome, Alcoholism, Alopecia, Amenorrhoea, Amnesia, Amniocentesis Abnormal, Amniotic Cavity Infection, Anaemia, Anal Stenosis, Anhedonia, Anomaly of External Ear Congenital, Anotia, Antepartum Haemorrhage, Anxiety, Apgar Score Low, Arrhythmia, Arrhythmia Neonatal, Aspartate Aminotransferase Increased, Asthenia, Asthma, Athetosis, Atrial Septal Defect, Atrioventricular Septal Defect, Autosomal Chromosome Anomaly, Back Pain, Bedridden, Benign Hydatidiform Mole, Bipolar Disorder, Blood Alcohol Increased, Blood Alkaline Phosphatase Increased, Blood Amino Acid Level Decreased, Blood Cholesterol Abnormal, Blood Cholesterol Increased, Blood Creatine Phosphokinase Increased, Blood Glucose Increased, Blood Pressure Fluctuation, Blood Pressure Increased, Blood Prolactin Increased, Blood Triglycerides Increased, Blood Uric Acid Increased, Bloody Discharge, Bone Tuberculosis, Brachial Plexopathy, Brachial Plexus Injury, Bradycardia, Bradycardia Foetal, Bradycardia Neonatal, Bradypnoea, Breast Cancer, Breech Delivery, Brief Psychotic Disorder With Postpartum Onset, Bronchitis, Bronchopneumonia, Caesarean Section, Calcinosis, Cardiac Arrest, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cardiomyopathy, Carotid Artery Dissection, Cephalo-Pelvic Disproportion, Cerebral Cyst, Cerebral Disorder, Cerebral Haemorrhage, Cerebral Haemorrhage Neonatal, Cerebral Infarction Foetal, Cerebral Palsy, Cerebral Ventricle Dilatation, Cerebrovascular Accident, Chest Pain, Cholelithiasis, Chorea, Chromosome Abnormality, Circulatory Failure Neonatal, Cleft Lip, Cleft Lip and Palate, Cleft Palate, Communication Disorder, Completed Suicide, Complication of Pregnancy, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Confusional State, Congenital Anomaly, Congenital Cardiovascular Anomaly, Congenital Central Nervous System Anomaly, Congenital Cyst, Congenital Diaphragmatic Hernia, Congenital Eyelid Malformation, Congenital Foot Malformation, Congenital Hand Malformation, Congenital Varicella Infection, C-Reactive Protein Increased, Convulsion, Convulsion Neonatal, Coronary Artery Atherosclerosis, Corrective Lens User, Cough, Cri Du Chat Syndrome, Crying, Cyanosis, Cyanosis Neonatal, Cytogenetic Abnormality, Dandy-Walker Syndrome, Death, Death Neonatal, Decreased Appetite, Dehydration, Delayed Recovery From Anaesthesia, Delirium, Delusion, Delusion of Reference, Delusional Disorder, Depression, Developmental Delay, Diabetes Complicating Pregnancy, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-dependent, Diabetic Coma, Diabetic Ketoacidosis, Diaphragmatic Hernia, Diarrhoea, Diet Refusal, Difficulty In Walking, Disease Recurrence, Disorientation, Dizziness, Dizziness Postural, Double Ureter, Drug Abuser, Drug Dependence, Drug Effect Decreased, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Screen False Positive, Drug Screen Positive, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dry Mouth, Dwarfism, Dyskinesia, Dyskinesia Neonatal, Dysphonia, Dysplasia, Dyspnoea, Dystonia, Ear Malformation, Embolism, Emotional Distress, Encephalocele, Endometriosis, Epistaxis, Escherichia Infection, Escherichia Sepsis, Excitability, Extrapyramidal Disorder, Eyelid Disorder, Facial Dysmorphism, Failure To Thrive, Fall, Fatigue, Feeding Disorder Neonatal, Feeding Problem In Child, Feeding Problem In Newborn, Feeling Guilty, Fibrocystic Breast Disease, Fibronectin Increased, Finger Deformity, Floppy Infant, Foetal Alcohol Syndrome, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Deceleration, Foetal Heart Rate Decreased, Foetal Heart Rate Disorder, Foetal Macrosomia, Foetal Movements Decreased, Foot Fracture, Forceps Delivery, Gait Disturbance, Galactorrhoea, Gangrene, Gastric Ulcer, Gastric Ulcer Haemorrhage, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Gastroschisis, General Physical Health Deterioration, Genital Haemorrhage, Gestational Diabetes, Glucose Tolerance Impaired, Glucose Urine Present, Glycosuria, Glycosuria During Pregnancy, Grand Mal Convulsion, Growth Retardation, Haemangioma Congenital, Haemangioma of Skin, Haematemesis, Haematochezia, Haematoma, Haemoglobin Decreased, Haemoglobin Increased, Haemorrhage, Hallucination (Auditory), Hallucination (Visual), Hallucinations (Mixed), Head Lag, Headache, Heart Disease Congenital, Heart Rate Increased, Heart Rate Irregular, Hemiparesis, Hepatic Enzyme Increased, Hepatic Function Abnormal, Hepatitis, Hiatus Hernia, Hip Dysplasia, Hospitalisation, Hydronephrosis, Hyperaesthesia, Hyperbilirubinaemia Neonatal, Hypercholesterolaemia, Hyperemesis Gravidarum, Hyperglycaemia, Hyperglycaemic Hyperosmolar Nonketotic Syndrome, Hypertelorism of Orbit, Hypertension, Hypertension Neonatal, Hypertonia, Hypertonia Neonatal, Hypertriglyceridaemia, Hyperventilation, Hypoacusis, Hypoaesthesia, Hypocalcaemia, Hypoglycaemia, Hypoglycaemia Neonatal, Hypokinesia Neonatal, Hyporeflexia, Hypospadias, Hypothyroidism, Hypotonia, Hypotonia Neonatal, Hypoventilation Neonatal, Hysterectomy, Impaired Work Ability, Inappropriate Antidiuretic Hormone Secretion, Incoherent, Increased Appetite, Induced Labour, Infantile Apnoeic Attack, Infarction, Infection, Infertility, Initial Insomnia, Injury, Injury Asphyxiation, Insomnia, Intentional Misuse, Intentional Overdose, Intentional Self-Injury, Intra-Uterine Death, Intraventricular Haemorrhage Neonatal, Irritability, Jaundice, Jaundice Neonatal, Ketoacidosis, Ketonuria, Kidney Malformation, Laboratory Test Abnormal, Large for Dates Baby, Lethargy, Leukocytosis, Leukopenia, Low Density Lipoprotein Increased, Low Set Ears, Lung Disorder, Macrosomia, Macrostomia, Major Depression, Malaise, Marital Problem, Masked Facies, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Maternal Use of Illicit Drugs, Meconium Ileus, Meconium In Amniotic Fluid, Meconium Stain, Memory Impairment, Meningocele, Menometrorrhagia, Mental Disability, Mental Disorder, Metabolic Disorder, Metabolic Syndrome, Metrorrhagia, Microcephaly, Monoplegia, Morbid Thoughts, Motor Dysfunction, Multiple Cardiac Defects, Multiple Congenital Abnormalities, Multiple Drug Overdose, Multiple Drug Overdose Intentional, Muscle Contractions Involuntary, Muscle Spasms, Muscular Weakness, Myocardial Infarction, Myocardial Ischaemia, Nasal Congestion, Nausea, Necrotising Enterocolitis Neonatal, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Complications of Substance Abuse, Neonatal Diabetes Mellitus, Neonatal Disorder, Neonatal Hypoxia, Neonatal Infection, Neonatal Intestinal Obstruction, Neonatal Oversedation, Neonatal Pneumonia, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachypnoea, Nephrolithiasis, Neural Tube Defect, Neuroleptic Malignant Syndrome, Nose Deformity, Nystagmus, Obesity, Obstructive Uropathy, Oedema, Oedema Peripheral, Oesophagitis, Off Label Use, Oligomenorrhoea, Optic Nerve Hypoplasia, Oral Candidiasis, Osteoarthritis, Osteoporosis, Otorhinolaryngological Surgery, Overdose, Pain, Palpitations, Pancreatitis, Panic Attack, Paralysis, Paranoia, Patent Ductus Arteriosus, Pelvic Fracture, Periventricular Leukomalacia, Persecutory Delusion, Persecutory Type, Pharmaceutical Product Complaint, Photosensitivity Reaction, Pilonidal Cyst Congenital, Placenta Praevia, Placenta Praevia Haemorrhage, Placental Insufficiency, Plantar Fasciitis, Platelet Count Decreased, Pneumonectomy, Pneumonia, Polycythaemia, Polydactyly, Polydipsia, Polyhydramnios, Polyuria, Poor Sucking Reflex, Poor Weight Gain Neonatal, Porencephaly, Postmature Baby, Postpartum Disorder, Postpartum Haemorrhage, Posture Abnormal, Pre-Eclampsia, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Prescribed Overdose, Preternatural Anus, Prolonged Labour, Prolonged Pregnancy, Protein Urine Present, Psychomotor Retardation, Psychotic Disorder, Pulmonary Congestion, Pulmonary Embolism, Pulmonary Haemorrhage, Pulmonary Hypertension, Pulmonary Oedema, Pyelonephritis, Pyrexia, Rash, Rectal Haemorrhage, Red Blood Cell Count Increased, Refusal of Examination, Refusal of Treatment By Patient, Renal Agenesis, Renal Colic, Renal Disorder, Renal Impairment, Renal Mass, Respiratory Disorder Neonatal, Respiratory Rate Increased, Respiratory Tract Infection, Respiratory Tract Infection Viral, Restlessness, Retained Placenta or Membranes, Retinitis, Retrognathia, Rhabdomyoma, Rheumatoid Arthritis, Rhinorrhoea, Road Traffic Accident, Salmonellosis, Schizoaffective Disorder, Schizophrenia, Sedation, Self Esteem Decreased, Sepsis, Serum Ferritin Decreased, Shift To the Left, Skin Laceration, Skull Malformation, Sleep Apnoea Syndrome, Sleep Disorder, Sluggishness, Small for Dates Baby, Smear Cervix Abnormal, Social Problem, Solitary Kidney, Somnolence, Somnolence Neonatal, Speech Disorder Developmental, Spine Malformation, Staphylococcal Sepsis, Stillbirth, Streptococcal Infection, Streptococcal Sepsis, Stress, Stress at Work, Stress Ulcer, Sudden Infant Death Syndrome, Suicide Attempt, Supernumerary Nipple, Syncope, Tachyarrhythmia, Tachycardia, Tachypnoea, Talipes, Tenderness, Tension, Therapeutic Agent Toxicity, Therapy Non-Responder, Threatened Labour, Thrombocythaemia, Thrombocytopenia, Thrombosis, Thyroxine Increased, Toe Amputation, Transient Tachypnoea of the Newborn, Transmission of Drug Via Semen, Tremor, Tremor Neonatal, Tricuspid Valve Incompetence, Trisomy 13, Trisomy 18, Trisomy 21, Tuberous Sclerosis, Ulcer, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Umbilical Cord Short, Umbilical Hernia, Urinary Bladder Haemorrhage, Urinary Tract Infection, Urinary Tract Malformation, Urine Sodium Increased, Uterine Haematoma, Uterine Haemorrhage, Uterine Hypotonus, Vacuum Extractor Delivery, Vaginal Disorder, Vaginal Haemorrhage, Vascular Injury, Vascular Skin Disorder, Ventricular Hypertrophy, Ventricular Septal Defect, Victim of Abuse, Viral Infection, Vision Blurred, Visual Acuity Reduced, Vocal Cord Paralysis, Vomiting, Vomiting Neonatal, Vulvovaginal Mycotic Infection, Weight Decrease Neonatal, Weight Decreased, Weight Gain Poor, Weight Increased, White Blood Cell Count Abnormal, White Blood Cell Count Decreased, Wound, Yellow Skin


Olanzapine Adverse Reaction Definitions
  
Abortion Spontaneous Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion.
  
Apgar Score A system of assessing the general physical condition of a newborn infant based on a rating of 0, 1, or 2 for five criteria: heart rate, respiration, muscle tone, skin color, and response to stimuli. The five scores are added together, with a perfect score being 10. (After Virginia Apgar (1909–1974), American physician)
  
Congenital A physical abnormality that is present at birth.
  
Congenital Anomaly Medical term for a birth defect which is a physical abnormality that is present at birth; they are also called congenital abnormalities. When multiple birth defects occur together and have a similar cause, they are called syndromes (e.g. Adrenogenital Syndrome, Dandy-Walker Syndrome, Digeorge's Syndrome, Drug Withdrawal Syndrome Neonatal.
  
Drug Withdrawal Syndrome Neonatal Refers to the characteristic signs and symptoms that appear when a drug that causes physical dependence is regularly used for a long time and then suddenly discontinued or decreased in dosage. Also known as abstinence syndrome. A group of unpleasant symptoms produced by the abrupt termination of drug taking. These symptoms, commonly called withdrawal symptoms, include anxiety, muscle weakness, nausea, vomiting, tremor, and a rapid heart beat.
  
Extrapyramidal Disorder Defects in basal ganglia function (the basal ganglia is a group of structures in the base of the brain involved in coordination and movement); characterized by changes in muscle tone, akinesia (loss or impariment of the power of voluntary movement), or dyskinesia (abnormal involuntary movements).
  
Floppy Infant Hypotonia.
  
Foetal Distress Syndrome An abnormal condition of a fetus during gestation or at the time of delivery, marked by altered heart rate or rhythm and leading to compromised blood flow or changes in blood chemistry.
  
Gestational Diabetes Gestational diabetes is a condition that occurs during pregnancy. Like other forms of diabetes, gestational diabetes involves a defect in the way the body processes and uses sugars (glucose) in the diet.
In diabetes, blood levels of glucose remain abnormally high. In many forms of diabetes, this is because the pancreas does not produce enough insulin.
In gestational diabetes, the pancreas is not at fault. Instead, the problem is in the placenta. During pregnancy, the placenta provides the baby with nourishment. It also produces a number of hormones that interfere with the body's usual response to insulin. This condition is referred to as "insulin resistance." Most pregnant women do not suffer from gestational diabetes, because the pancreas works to produce extra quantities of insulin in order to compensate for insulin resistance. However, when a woman's pancreas cannot produce enough extra insulin, blood levels of glucose stay abnormally high, and the woman is considered to have gestational diabetes.
  
Hyperglycaemia The presence of an abnormally high concentration of glucose in the blood.
  
Hypertonia Extreme tension of the muscles or arteries.
  
Hypoglycemia The condition called hypoglycemia is literally translated as low blood sugar. Hypoglycemia occurs when blood sugar (or blood glucose) concentrations fall below a level necessary to properly support the body's need for energy and stability throughout its cells.
  
Hypospadias Congenital anomaly in which the urethra (the canal through which urine is discharged from the bladder) opens on the ventral (lower) surface of the penis or in the perineum (area between scrotum and anus). Congenital anomaly in which the urethra opens into the vagina.
  
Hypotonia Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension.
  
Monoplegia Complete paralysis of a single limb, muscle, or muscle group.
  
Neural Tube Defect Any of various congenital defects of the brain and spinal cord, such as spina bifida, resulting from incomplete closing of the neural tube in an embryo.
  
Periventricular Leukomalacia Periventricular leukomalacia is a brain condition affecting fetuses and newborns in which there is softening, dysfunction, and death of the white matter of the brain.
  
Pre-Eclampsia Abnormal state of pregnancy characterized by hypertension and fluid retention and albuminuria (the presence of albumin in the urine, sometimes indicating kidney disease); if untreated, can lead to eclampsia (coma and convulsions before, during, or shortly after childbirth, characterized by edema, hypertension, and proteinuria).
  
Spina Bifida A serious birth abnormality in which the spinal cord is malformed and lacks its usual protective skeletal and soft tissue coverings.
Spina bifida may appear in the body midline anywhere from the neck to the buttocks. In its most severe form, termed spinal rachischisis, the entire spinal canal is open, exposing the spinal cord and nerves. More commonly, the abnormality appears as a localized mass on the back that is covered by skin or by the meninges, the three-layered membrane that envelopes the spinal cord. Spina bifida is usually readily apparent at birth because of the malformation of the back and paralysis below the level of the abnormality.
  
Syndactyly A congenital anomaly in humans characterized by two or more fused fingers or toes.
  
Tremor Tremor is an unintentional (involuntary), rhythmical alternating movement that may affect the muscles of any part of the body. Tremor is caused by the rapid alternating contraction and relaxation of muscles and is a common symptom of diseases of the nervous system (neurologic disease).
  
Trisomy 13 Patau syndrome, also called trisomy 13, is a congenital (present at birth) disorder associated with the presence of an extra copy of chromosome 13. The extra chromosome 13 causes numerous physical and mental abnormalities, especially heart defects.
  
Trisomy 18 Edwards' syndrome is caused by an extra (third) copy of chromosome 18. The extra chromosome is lethal for most babies born with this condition. It causes major physical abnormalities and severe mental retardation. Very few children afflicted with this syndrome survive beyond the first year.
  
Trisomy 21 Down syndrome is the most common cause of mental retardation and malformation in a newborn. It occurs because of the presence of an extra chromosome. The extra chromosome in Down syndrome is labeled number 21. For this reason, the existence of three such chromosomes is sometimes referred to as Trisomy 21.
  

MedWatch Reporting by Consumers

MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Olanzapine and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.

A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".