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 | |||||||||||
Olanzapine (olanzapine), Zyprexa (olanzapine), Zyprexa Zydis (olanzapine)
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 (19091974), 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 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".