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 | 3901682 | 4922542 | 02/24/2006 | Wellbutrin | OT | Depression | Aortic Valve Stenosis, Bicuspid Aortic Valve, Drug Exposure During Pregnancy, Heart Disease Congenital, Mitral Valve Stenosis | |||||||
| M | 4011323 | 4279456 | 01/27/2004 | Wellbutrin | MD | Depression | Abdominal Wall Anomaly, Arteriopathic Disease, Chorioamnionitis, Cleft Palate, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy, Ear Malformation, Intra-Uterine Death, Jaw Fracture, Kyphosis, Liver Disorder, Lymphangiectasia, Macrognathia, Nose Deformity, Pectus Excavatum, Placental Disorder, Spleen Malformation, Thyroid Disorder, Traumatic Delivery | |||||||
| 4054367 | 4263257 | 01/05/2004 | Bupropion | OT | Aorta Hypoplasia, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy | |||||||||
| 4054367 | 4273114 | 01/16/2004 | Bupropion | OT | Abortion Induced, Aorta Hypoplasia, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy | |||||||||
| M | 4055029 | 4264450 | 09/01/2002 | 01/06/2004 | Zyban | MD | Ex-Smoker | Congenital Anomaly, Drug Exposure During Pregnancy, Talipes | ||||||
| F | 4079766 | 4285106 | 02/04/2004 | Wellbutrin | CN | Depression | Convulsion, Drug Exposure During Pregnancy, Dyspepsia, Headache, Loss of Consciousness, Neck Pain | |||||||
| 4093063 | 4301842 | 02/23/2004 | Bupropion | MD | Drug Use for Unknown Indication | Convulsion, Drug Exposure Via Breast Milk | ||||||||
| 4108345 | 4318139 | 12/01/2003 | 03/17/2004 | Bupropion | OT | Depression | Drug Exposure During Pregnancy, Trisomy 18 | |||||||
| F | 4115287 | 4325960 | 03/29/2004 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Fungal Infection, Nephrolithiasis, Urinary Tract Infection | |||||||
| M | 4117603 | 4329733 | 12/29/2003 | 04/01/2004 | Bupropion | OT | Depression | Drug Exposure During Pregnancy, Haemangioma, Talipes | ||||||
| M | 4125775 | 4339432 | 01/01/2003 | 04/15/2004 | Bupropion | OT | Drug Exposure During Pregnancy, Sudden Infant Death Syndrome | |||||||
| M | 4125775 | 4376085 | 01/01/2003 | 06/11/2004 | Bupropion | OT | Drug Exposure During Pregnancy, Sudden Infant Death Syndrome | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 4144643 | 4364438 | 05/25/2004 | Wellbutrin | CN | Drug Use for Unknown Indication | Abortion Spontaneous | |||||||
| F | 4146413 | 4366582 | 05/27/2004 | Wellbutrin | CN | Ill-Defined Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| 4151234 | 4373280 | 06/08/2004 | Zyban | MD | Ex-Smoker | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 21 | ||||||||
| 4157163 | 4381499 | 04/06/2004 | 06/21/2004 | Bupropion | MD | Depression | Drug Exposure During Pregnancy, Vocal Cord Paralysis | |||||||
| F | 4161014 | 4386599 | 06/29/2004 | Wellbutrin | CN | Drug Use for Unknown Indication | Abortion Spontaneous | |||||||
| M | 4162227 | 4387785 | 03/29/2004 | 06/30/2004 | Bupropion | OT | Drug Exposure During Pregnancy, Jaundice, Pulmonary Oedema | |||||||
| M | 4195973 | 4427264 | 07/29/2004 | 08/13/2004 | Wellbutrin | MD | Coloboma, Congenital Eye Disorder, Cryptophthalmos, Drug Exposure During Pregnancy | |||||||
| F | 4223518 | 4467312 | 01/01/2004 | 10/06/2004 | 06/14/2004 | Zyban | CN | Chromosome Abnormality, Congenital Hand Malformation, Diaphragmatic Hernia, Foetal Growth Retardation, Foetal Malformation, Gastrointestinal Disorder | ||||||
| F | 4223518 | 4484243 | 01/01/2003 | 10/25/2004 | 06/14/2004 | Zyban | MD | Chromosome Abnormality, Congenital Hand Malformation, Dextrocardia, Diaphragmatic Hernia, Drug Exposure During Pregnancy, Foetal Growth Retardation, Foetal Malformation, Gastrointestinal Disorder | ||||||
| F | 4223518 | 4514057 | 01/01/2003 | 11/30/2004 | 06/14/2004 | Zyban | MD | Smoking Cessation Therapy | Autosomal Chromosome Anomaly, Chromosome Abnormality, Congenital Hand Malformation, Dextrocardia, Diaphragmatic Hernia, Drug Exposure During Pregnancy, Foetal Growth Retardation, Foetal Malformation, Gastrointestinal Disorder, Trisomy 15 | |||||
| M | 4747293 | 4685361 | 06/08/2005 | Wellbutrin | OT | Apnoea, Cyanosis, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Respiratory Distress | ||||||||
| 5659479 | 4494303 | 11/05/2004 | Bupropion | OT | Depression | Drug Exposure During Pregnancy, Kidney Malformation, Renal Disorder | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 5659479 | 4508904 | 09/28/2004 | 11/23/2004 | Bupropion | OT | Depression | Double Ureter, Drug Exposure During Pregnancy, Renal Disorder, Vesicoureteric Reflux | ||||||
| M | 5659479 | 4548479 | 09/28/2004 | 01/10/2005 | Bupropion | OT | Depression | Double Ureter, Drug Exposure During Pregnancy, Renal Disorder, Vesicoureteric Reflux | ||||||
| 5680469 | 4508199 | 09/01/2003 | 11/23/2004 | Wellbutrin | CN | Depression | Convulsion, Drug Exposure Via Breast Milk | |||||||
| F | 5680912 | 4508628 | 11/23/2004 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk | |||||||
| M | 5681091 | 4508823 | 11/23/2004 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Lethargy | |||||||
| 5697797 | 4530721 | 12/17/2004 | Zyban | CN | Drug Exposure During Pregnancy, Ear Disorder | |||||||||
| F | 5701388 | 4536190 | 09/17/2004 | 12/23/2004 | Bupropion | OT | Depression | Chorioamnionitis, Drug Exposure During Pregnancy, Intra-Uterine Death, Micrognathia, Umbilical Cord Abnormality | ||||||
| 5709722 | 4263257 | 01/05/2004 | Bupropion | OT | Aorta Hypoplasia, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy | |||||||||
| 5709722 | 4273114 | 01/16/2004 | Bupropion | OT | Abortion Induced, Aorta Hypoplasia, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy | |||||||||
| M | 5709745 | 4546488 | 01/06/2005 | Wellbutrin | OT | Depression | Drug Exposure During Pregnancy, Pulmonary Hypertension | |||||||
| F | 5733431 | 4575065 | 02/08/2005 | Wellbutrin | CN | Drug Use for Unknown Indication | Abortion Spontaneous | |||||||
| F | 5735790 | 4578736 | 07/01/2004 | 02/11/2005 | Zyban | MD | Ex-Smoker | 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 | 5743727 | 4588849 | 02/22/2005 | Bupropion | OT | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| F | 5748695 | 4594139 | 03/01/2005 | Wellbutrin | PH | Depression | Abortion Spontaneous | |||||||
| 5758454 | 4608825 | 03/15/2005 | Wellbutrin | OT | Drug Use for Unknown Indication | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| M | 5765744 | 4619162 | 03/25/2005 | Zyban | MD | Smoking Cessation Therapy | Abortion Induced, Asphyxiating Thoracic Dystrophy, Drug Exposure During Pregnancy, Limb Deformity | |||||||
| F | 5766374 | 4620530 | 03/28/2005 | Wellbutrin | CN | Depression | Abortion Spontaneous, Agitation, Chills, Drug Exposure During Pregnancy, Insomnia, Paraesthesia | |||||||
| F | 5775754 | 4629326 | 04/05/2005 | Wellbutrin | Drug Exposure During Pregnancy, Stillbirth | |||||||||
| F | 5775759 | 4629327 | 04/05/2005 | Wellbutrin | Drug Exposure During Pregnancy, Premature Separation of Placenta | |||||||||
| 5775763 | 4629328 | 04/05/2005 | Wellbutrin | Death Neonatal, Drug Exposure During Pregnancy | ||||||||||
| M | 5782558 | 4645199 | 03/17/2005 | 04/26/2005 | Bupropion | OT | Hypospadias, Microtia | |||||||
| M | 5782558 | 4661408 | 05/13/2005 | Wellbutrin | OT | Hypospadias, Microtia | ||||||||
| M | 5787647 | 4651851 | 05/04/2005 | Wellbutrin | CN | Congenital Eye Disorder, Drug Exposure During Pregnancy | ||||||||
| M | 5787647 | 4738368 | 08/09/2005 | Wellbutrin | CN | Drug Use for Unknown Indication | Coloboma, Drug Exposure During Pregnancy, Microphthalmos | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 5787647 | 4757634 | 08/31/2005 | Wellbutrin | MD | Depression | Coloboma, Drug Exposure During Pregnancy, Microphthalmos | |||||||
| F | 5800461 | 4667756 | 05/20/2005 | Bupropion | OT | Drug Exposure During Pregnancy, Failure To Thrive, Laryngomalacia, Stridor | ||||||||
| F | 5800461 | 4825779 | 11/11/2005 | Wellbutrin | OT | Major Depression | Drug Exposure During Pregnancy, Failure To Thrive, Laryngomalacia, Stridor | |||||||
| 5803829 | 4673425 | 05/25/2005 | Wellbutrin | CN | Drug Exposure During Pregnancy, Jaundice Neonatal | |||||||||
| F | 5803829 | 4698146 | 06/23/2005 | Wellbutrin | CN | Drug Exposure During Pregnancy, Jaundice Neonatal, Premature Baby | ||||||||
| 5810215 | 4679354 | 06/02/2005 | Bupropion | OT | Anencephaly, Drug Exposure During Pregnancy | |||||||||
| 5810215 | 4698148 | 06/23/2005 | Wellbutrin | OT | Abortion Induced, Anencephaly, Drug Exposure During Pregnancy, Stillbirth | |||||||||
| 5810215 | 4736859 | 08/08/2005 | Wellbutrin | OT | Major Depression | Abortion Induced, Alpha 1 Foetoprotein Abnormal, Anencephaly, Drug Exposure During Pregnancy | ||||||||
| F | 5812226 | 4678972 | 05/31/2005 | Wellbutrin | MD | Drug Exposure During Pregnancy, Dysphagia, Neonatal Disorder | ||||||||
| 5826088 | 4700047 | 06/27/2005 | Wellbutrin | CN | Drug Exposure During Pregnancy, Nervous System Disorder | |||||||||
| F | 5869530 | 4756236 | 08/30/2005 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk | |||||||
| M | 5869731 | 4756436 | 06/01/2005 | 08/30/2005 | Wellbutrin | CN | Depression | Drug Exposure Via Breast Milk, 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 | ||||
| 5869800 | 4756505 | 08/30/2005 | Wellbutrin | CN | Breast Feeding | Drug Exposure Via Breast Milk | ||||||||
| 5869828 | 4756533 | 07/15/2005 | 08/30/2005 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk | |||||||
| F | 5875934 | 4766002 | 09/06/2005 | 09/12/2005 | Wellbutrin | CN | Depression | Convulsion, Drug Exposure During Pregnancy | ||||||
| M | 5875934 | 4776989 | 09/06/2005 | 09/23/2005 | Wellbutrin | CN | Depression | Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy | ||||||
| M | 5875934 | 4843793 | 09/06/2005 | 12/02/2005 | Wellbutrin | CN | Depression | Convulsion, Drug Exposure During Pregnancy | ||||||
| M | 5886104 | 4779950 | 09/27/2005 | Wellbutrin | OT | Major Depression | Cryptorchism, Drug Exposure During Pregnancy | |||||||
| M | 5886104 | 4816993 | 11/01/2005 | Wellbutrin | OT | Major Depression | Cryptorchism, Drug Exposure During Pregnancy | |||||||
| M | 5886104 | 4818075 | 11/02/2005 | Wellbutrin | OT | Major Depression | Cryptorchism, Drug Exposure During Pregnancy | |||||||
| M | 5886104 | 5147998 | 11/10/2006 | Wellbutrin | OT | Major Depression | Campbell De Morgan Spots, Cryptorchism, Drug Exposure During Pregnancy | |||||||
| F | 5897302 | 4795290 | 10/12/2005 | Wellbutrin | OT | Major Depression | Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged | |||||||
| F | 5922924 | 4828186 | 11/15/2005 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Infantile Apnoeic Attack | |||||||
| F | 5925175 | 4831377 | 11/18/2005 | Bupropion | OT | 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 | ||||
| 5958497 | 4877549 | 01/11/2006 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Heart Disease Congenital, Pulmonary Hypertension | ||||||||
| F | 5964596 | 4886162 | 01/20/2006 | Bupropion | OT | Major Depression | Apnoea, Cardiac Murmur, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Milk Allergy | |||||||
| F | 5970965 | 4894205 | 01/27/2006 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy | |||||||
| 5988090 | 4917382 | 02/21/2006 | Wellbutrin | OT | Major Depression | Anencephaly, Drug Exposure During Pregnancy | ||||||||
| M | 5992710 | 4924221 | 02/27/2006 | Wellbutrin | CN | Depression | Drug Exposure Via Breast Milk | |||||||
| F | 6008572 | 4949031 | 03/13/2006 | 03/21/2006 | Bupropion | OT | Abortion Spontaneous | |||||||
| F | 6032385 | 4983178 | 04/26/2006 | Bupropion | CN | Major Depression | Blood Bilirubin Increased, Drug Exposure During Pregnancy | |||||||
| F | 6037590 | 4991700 | 05/04/2006 | Wellbutrin | OT | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| 6054851 | 5013610 | 05/30/2006 | Wellbutrin | OT | Convulsion, Drug Exposure Via Breast Milk | |||||||||
| 6064263 | 5025169 | 06/13/2006 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Trisomy 21 | ||||||||
| 6064263 | 5083571 | 08/18/2006 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy | ||||||||
| 6065730 | 5026648 | 06/15/2006 | Bupropion | OT | Abortion Induced, Drug Exposure During Pregnancy, Foetal Disorder | |||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6067502 | 5028907 | 06/19/2006 | Wellbutrin | MD | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Skin Exfoliation, Staphylococcal Scalded Skin Syndrome | |||||||||
| F | 6082582 | 5051625 | 04/18/2006 | 07/14/2006 | Bupropion | OT | Alpha 1 Foetoprotein Abnormal, Amniotic Fluid Volume Decreased, Drug Exposure During Pregnancy, Gestational Diabetes, Premature Rupture of Membranes | |||||||
| F | 6082582 | 5080577 | 04/18/2006 | 08/15/2006 | Bupropion | OT | Alpha 1 Foetoprotein Abnormal, Amniotic Fluid Volume Decreased, Drug Exposure During Pregnancy, Gestational Diabetes, Isoimmunisation, Premature Rupture of Membranes | |||||||
| M | 6082583 | 5051626 | 07/14/2006 | Bupropion | OT | Colostomy, Drug Exposure During Pregnancy, Ileal Perforation, Life Support, Necrotising Colitis, Thrombocytopenia Neonatal | ||||||||
| M | 6083310 | 5052573 | 07/17/2006 | Bupropion | OT | Major Depression | Premature Labour | |||||||
| 6097971 | 5069773 | 08/03/2006 | Bupropion | OT | Major Depression | Abdominal Transposition, Atrioventricular Septal Defect, Drug Exposure During Pregnancy, Pulmonary Valve Stenosis Congenital | ||||||||
| 6097971 | 5246956 | 02/26/2007 | Bupropion | OT | Major Depression | Abdominal Transposition, Atrioventricular Septal Defect, Drug Exposure During Pregnancy, Pulmonary Valve Stenosis Congenital | ||||||||
| F | 6116884 | 5090462 | 08/28/2006 | Wellbutrin | CN | Depression | Drug Exposure Via Breast Milk | |||||||
| F | 6121280 | 5096016 | 09/05/2006 | Bupropion | OT | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| F | 6121280 | 5112708 | 09/22/2006 | Bupropion | OT | Drug Exposure During Pregnancy | ||||||||
| F | 6124042 | 5099704 | 09/08/2006 | Bupropion | OT | Intentional Overdose | Atrial Septal Defect, Caesarean Section, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Poor Weight Gain Neonatal | |||||||
| F | 6125883 | 5102552 | 09/12/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Placental Disorder, Small for Dates 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 | 6150540 | 5131398 | 10/20/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Hydrocele, Inguinal Hernia | |||||||
| M | 6150540 | 5146035 | 11/08/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Hydrocele, Inguinal Hernia | |||||||
| M | 6153159 | 5134626 | 10/25/2006 | Wellbutrin | MD | Major Depression | Drug Exposure During Pregnancy, Hernia Congenital, Infection | |||||||
| M | 6153159 | 5135413 | 10/26/2006 | Wellbutrin | CN | Major Depression | Drug Exposure During Pregnancy, Infection, Inguinal Hernia | |||||||
| F | 6172347 | 5156305 | 11/22/2006 | Wellbutrin | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Intra-Uterine Death | |||||||
| F | 6175412 | 5159837 | 11/29/2006 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy | |||||||
| F | 6175626 | 5160045 | 11/29/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy | |||||||
| F | 6176764 | 5161428 | 11/30/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy | |||||||
| F | 6176769 | 5161433 | 11/30/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy | |||||||
| F | 6176871 | 5161537 | 11/30/2006 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Administration Error, Drug Exposure During Pregnancy | |||||||
| F | 6176927 | 5161592 | 11/30/2006 | Wellbutrin | CN | Bipolar Disorder | Affective Disorder, Bipolar Disorder, Drug Exposure During Pregnancy, Drug Ineffective | |||||||
| 6176928 | 5161593 | 11/30/2006 | Wellbutrin | CN | Bipolar Disorder | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, General Physical Health Deterioration | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6177235 | 5161930 | 10/27/2006 | 11/30/2006 | Wellbutrin | CN | Drug Exposure Via Breast Milk | ||||||||
| F | 6184131 | 5171077 | 12/13/2006 | Wellbutrin | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Transmission of Drug Via Semen | |||||||
| 6225456 | 5222091 | 01/29/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk | ||||||||
| 6225505 | 5222141 | 01/29/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk | ||||||||
| F | 6225602 | 5222240 | 01/29/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk | |||||||
| F | 6230575 | 5228663 | 02/05/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy, Rectal Haemorrhage | |||||||
| M | 6252239 | 5254266 | 03/02/2007 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Hypospadias | |||||||
| M | 6252240 | 5254267 | 03/02/2007 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Transposition of the Great Vessels | |||||||
| F | 6257232 | 5259931 | 03/09/2007 | Bupropion | OT | Major Depression | Anorexia, Drug Exposure During Pregnancy, Poor Weight Gain Neonatal | |||||||
| F | 6257232 | 5374799 | 06/29/2007 | Bupropion | OT | Major Depression | Anorexia, Drug Exposure During Pregnancy, Poor Weight Gain Neonatal, Premature Baby, Small for Dates Baby | |||||||
| F | 6263461 | 5267275 | 03/16/2007 | Wellbutrin | CN | Drug Exposure During Pregnancy | ||||||||
| M | 6263463 | 5267277 | 03/16/2007 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Trisomy 21 | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6270650 | 5275747 | 09/05/2006 | 03/26/2007 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Fallot's Tetralogy | ||||||
| M | 6270650 | 5277083 | 09/05/2006 | 03/27/2007 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Fallot's Tetralogy | ||||||
| 6271916 | 5277098 | 03/27/2007 | Bupropion | CN | Major Depression | Drug Exposure During Pregnancy, Trisomy 18 | ||||||||
| F | 6278301 | 5284536 | 04/03/2007 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| M | 6297177 | 5308687 | 04/26/2007 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Premature Baby | |||||||
| M | 6308845 | 5321446 | 05/10/2007 | Bupropion | OT | Neonatal Aspiration | ||||||||
| F | 6364112 | 5393849 | 07/23/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| 6364113 | 5393850 | 07/23/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Foetal Arrhythmia | ||||||||
| F | 6374929 | 5405282 | 08/03/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Ventricular Septal Defect | |||||||
| 6382303 | 5413695 | 08/14/2007 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Premature Baby | ||||||||
| F | 6394659 | 5430819 | 08/30/2007 | Wellbutrin | CN | Obsessive-Compulsive Disorder | Drug Exposure During Pregnancy, Drug Ineffective | |||||||
| F | 6394683 | 5430842 | 08/30/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Live Birth | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6394709 | 5430867 | 08/30/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk | ||||||||
| 6394717 | 5430875 | 08/30/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk | ||||||||
| F | 6395295 | 5431460 | 08/30/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy | |||||||
| F | 6424612 | 5464308 | 09/21/2007 | Zyban | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy | |||||||
| F | 6435359 | 5477152 | 10/04/2007 | Bupropion | MD | Major Depression | Abortion Spontaneous, Anxiety, Nervousness | |||||||
| M | 6436465 | 5551098 | 07/24/2007 | 12/12/2007 | Wellbutrin | OT | Depression | Drug Exposure During Pregnancy, Infection, Pulmonary Hypertension | ||||||
| F | 6442780 | 5486447 | 10/16/2007 | Wellbutrin | CN | Depression | Affect Lability, Depression, Drug Exposure During Pregnancy, Fatigue, Gestational Diabetes, Mania, Stress, Thinking Abnormal | |||||||
| M | 6442781 | 5486448 | 10/16/2007 | Wellbutrin | CN | Depression | Affective Disorder, Asperger's Disorder, Attention Deficit/Hyperactivity Disorder, Drug Exposure During Pregnancy, Premature Baby | |||||||
| F | 6460693 | 5508761 | 11/07/2007 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Encephalopathy | |||||||
| 6471043 | 5520898 | 11/19/2007 | Zyban | CN | Brain Stem Syndrome, Drug Exposure During Pregnancy, Kidney Malformation | |||||||||
| F | 6473101 | 5523371 | 11/21/2007 | Zyban | CN | Abortion Induced | ||||||||
| 6477066 | 5529045 | 03/02/2006 | 11/29/2007 | Wellbutrin | CN | Seasonal Affective Disorder | Drug Exposure Via Breast Milk | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6477083 | 5529063 | 11/29/2007 | Wellbutrin | CN | Depression | Drug Effect Decreased, Drug Exposure During Pregnancy, Dry Mouth, Feeling Abnormal, Memory Impairment | |||||||
| F | 6483212 | 5537385 | 12/07/2007 | Bupropion | CN | Anxiety | Chromosomal Deletion, Cri Du Chat Syndrome, Drug Exposure During Pregnancy | |||||||
| F | 6483212 | 5655235 | 03/07/2008 | Bupropion | CN | Anxiety | Chromosomal Deletion, Cri Du Chat Syndrome, Drug Exposure During Pregnancy | |||||||
| M | 6487277 | 5541761 | 12/10/2007 | Wellbutrin | CN | Depression | Asthma, Drug Exposure During Pregnancy, Premature Baby | |||||||
| F | 6513054 | 5571728 | 12/21/2007 | Bupropion | CN | Major Depression | Drug Exposure During Pregnancy, Foetal Growth Retardation | |||||||
| F | 6537517 | 5606221 | 01/29/2008 | Bupropion | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy | |||||||
| F | 6537641 | 5606345 | 07/01/2007 | 01/29/2008 | Wellbutrin | CN | Drug Use for Unknown Indication | Disorientation, Drug Exposure During Pregnancy, Sensory Disturbance, Withdrawal Syndrome | ||||||
| M | 6581110 | 5664472 | 03/14/2008 | Bupropion | OT | Major Depression | Congenital Hand Malformation, Drug Exposure During Pregnancy | |||||||
| M | 6487277 | 5734844 | 05/12/2008 | Wellbutrin | CN | Depression | Asthma, Blood Bicarbonate Increased, Dermatitis Diaper, Diarrhoea, Drug Exposure During Pregnancy, Erythema, Gastroenteritis, Hyperbilirubinaemia, Irritability, Jaundice, Ocular Icterus, Premature Baby, Pyrexia, Respiratory Distress, Viral Upper Respiratory Tract Infection, Vomiting | |||||||
| 0 | Days | M | 6537571 | 5606274 | 04/14/2007 | 01/29/2008 | Bupropion | CN | Postpartum Depression | Drug Exposure Via Breast Milk, Insomnia, Irritability, Nervousness | ||||
| F | 6621760 | 5714591 | 03/10/2007 | 04/23/2008 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Jaundice Neonatal | ||||||
| 6650605 | 5750810 | 05/28/2008 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Foetal Malformation | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 2 | Days | F | 5882173 | 4773813 | 09/20/2005 | Wellbutrin | OT | Major Depression | Convulsion, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk | |||||
| 2 | Days | F | 5882173 | 4795296 | 10/12/2005 | Wellbutrin | OT | Major Depression | Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk | |||||
| 3 | Days | 5881465 | 4772760 | 09/19/2005 | Wellbutrin | CN | Depression | Anencephaly, Drug Exposure During Pregnancy | ||||||
| 3 | Months | M | 5932566 | 4841637 | 11/30/2005 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk, Insomnia | |||||
| 3 | Months | M | 6175409 | 5159834 | 11/29/2006 | Wellbutrin | CN | Depression | Drug Exposure Via Breast Milk | |||||
| 4 | Months | F | 6116895 | 5090473 | 05/07/2006 | 08/28/2006 | Wellbutrin | CN | Cough, Drug Exposure Via Breast Milk, Lacrimation Increased, Rhinorrhoea | |||||
| 20 | Weeks | 5992609 | 4924117 | 02/27/2006 | Wellbutrin | CN | Depression | Drug Exposure Via Breast Milk, Painful Response To Normal Stimuli | ||||||
| 5 | Months | F | 6175658 | 5160077 | 09/11/2006 | 11/29/2006 | Bupropion | CN | Depression | Drug Exposure Via Breast Milk, Irritability | ||||
| 6 | Months | M | 4055029 | 4269206 | 09/01/2002 | 01/13/2004 | Zyban | MD | Ex-Smoker | Congenital Anomaly, Drug Exposure During Pregnancy, Talipes | ||||
| 6 | Months | M | 4055029 | 4279476 | 09/01/2002 | 01/27/2004 | Zyban | MD | Congenital Anomaly, Drug Exposure During Pregnancy, Talipes | |||||
| 6 | Months | F | 4093063 | 4325957 | 05/25/2003 | 03/29/2004 | Bupropion | MD | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk, Grand Mal Convulsion | ||||
| 6 | Months | F | 5650990 | 4476558 | 05/25/2003 | 10/13/2004 | Wellbutrin | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk, Febrile Convulsion, Grand Mal Convulsion, Postictal State, Restlessness, Upper Respiratory Tract Infection | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6 | Months | F | 5650990 | 4725754 | 05/25/2003 | 07/25/2005 | Wellbutrin | Drug Use for Unknown Indication | Drug Exposure Via Breast Milk, Grand Mal Convulsion, Restlessness, Staring, Upper Respiratory Tract Infection | |||||
| 8 | Months | M | 5806344 | 4676101 | 05/27/2005 | Wellbutrin | CN | Anorexia, Drug Exposure Via Breast Milk, Irritability, Somnolence | ||||||
| 1 | Year | M | 6225337 | 5221971 | 02/15/2006 | 01/29/2007 | Wellbutrin | CN | Anorexia, Diarrhoea, Drug Exposure Via Breast Milk | |||||
| 1 | Year | F | 6395167 | 5431334 | 08/30/2007 | Wellbutrin | CN | Depression | Drug Exposure Via Breast Milk | |||||
| 2 | Years | F | 6057000 | 5016611 | 06/02/2006 | Wellbutrin | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Partial Seizures | |||||
| 2 | Years | M | 6236206 | 5235645 | 02/01/2006 | 02/12/2007 | Wellbutrin | CN | Nervous System Disorder | Convulsion, Drug Exposure During Pregnancy | ||||
| 15 | Years | F | 5882170 | 4773810 | 09/14/2005 | 09/20/2005 | 09/16/2005 | Wellbutrin | CN | Depression | Abortion, Cardio-Respiratory Arrest, Completed Suicide, Convulsion, Drug Exposure During Pregnancy, Overdose | |||
| 15 | Years | F | 5882170 | 4778372 | 09/14/2005 | 09/26/2005 | 09/16/2005 | Wellbutrin | CN | Depression | Convulsion, Myocardial Infarction, Overdose, Suicide Attempt | |||
| 15 | Years | F | 5882170 | 4853274 | 09/14/2005 | 12/14/2005 | 09/16/2005 | Wellbutrin | CN | Depression | Convulsion, Myocardial Infarction, Overdose, Suicide Attempt | |||
| 16 | Years | F | 5756002 | 4605953 | 03/01/2005 | 03/11/2005 | Wellbutrin | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 19 | Years | F | 5925169 | 4831371 | 11/14/2005 | 11/18/2005 | Wellbutrin | CN | Postpartum Depression | Convulsion, Intentional Overdose, Tachycardia | ||||
| 19 | Years | F | 5925169 | 4853281 | 11/14/2005 | 12/14/2005 | Wellbutrin | CN | Postpartum Depression | Convulsion, Drug Exposure During Pregnancy, Intentional Overdose, Postictal State, Tachycardia | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 19 | Years | F | 6186763 | 5173793 | 04/01/2006 | 12/14/2006 | Bupropion | CN | Bipolar Disorder | Bruxism, Convulsion, Drug Exposure During Pregnancy, Nausea, Pharmaceutical Product Complaint, Posture Abnormal, Speech Disorder, Tongue Biting, Tremor | ||||
| 20 | Years | F | 5756002 | 4627136 | 02/14/2005 | 04/05/2005 | Wellbutrin | CN | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 20 | Years | F | 5957103 | 4875093 | 01/09/2006 | Bupropion | OT | Intentional Overdose | Drug Exposure During Pregnancy, Intentional Overdose | |||||
| 20 | Years | F | 5957103 | 5099703 | 09/08/2006 | Bupropion | OT | Intentional Overdose | Caesarean Section, Drug Exposure During Pregnancy, Intentional Overdose | |||||
| 20 | Years | F | 6176771 | 5161435 | 11/30/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy | |||||
| 20 | Years | F | 6201491 | 5190476 | 12/22/2006 | Bupropion | OT | Major Depression | Caesarean Section, Dehydration, Drug Exposure During Pregnancy, Gestational Diabetes, Headache, Nausea, Vomiting | |||||
| 21 | Years | F | 5866722 | 4752293 | 05/01/2005 | 08/25/2005 | Wellbutrin | CN | Depression | Amnesia, Drug Exposure During Pregnancy, Eclampsia, Grand Mal Convulsion, Headache, Tongue Biting | ||||
| 22 | Years | F | 4094521 | 4303875 | 01/21/2004 | 02/25/2004 | Zyban | CN | Ex-Smoker | Arthralgia, C-Reactive Protein Increased, Drug Exposure During Pregnancy, Face Oedema, Joint Swelling, Mobility Decreased, Neutrophil Percentage Increased, Odynophagia, Oedema, Urticaria, White Blood Cell Count Increased | ||||
| 22 | Years | F | 4094521 | 4523685 | 01/21/2004 | 12/10/2004 | Zyban | MD | Smoking Cessation Therapy | Arthralgia, C-Reactive Protein Increased, Drug Exposure During Pregnancy, Face Oedema, Joint Swelling, Neutrophil Percentage Increased, Odynophagia, Oedema, Urticaria, White Blood Cell Count Increased | ||||
| 22 | Years | F | 4097677 | 4306895 | 01/13/2004 | 02/27/2004 | Zyban | MD | Ex-Smoker | Abortion Missed, Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death | ||||
| 22 | Years | F | 4140541 | 4359027 | 05/17/2004 | Bupropion | OT | Depression | Abortion Spontaneous | |||||
| 22 | Years | F | 4151205 | 4373241 | 05/25/2004 | 06/08/2004 | Bupropion | OT | 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 | ||||
| 22 | Years | F | 4157164 | 4381500 | 06/21/2004 | Bupropion | CN | Depression | Drug Exposure During Pregnancy, Metrorrhagia | |||||
| 23 | Years | F | 5952652 | 4868379 | 12/29/2005 | Bupropion | OT | Depression | Abdominal Tenderness, Abortion Spontaneous, Premature Rupture of Membranes, Pyrexia | |||||
| 23 | Years | F | 6138396 | 5116650 | 09/28/2006 | Bupropion | CN | Major Depression | Abortion Induced, Drug Exposure During Pregnancy | |||||
| 24 | Years | F | 4196933 | 4433857 | 08/26/2004 | Bupropion | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 24 | Years | F | 6060124 | 5020041 | 04/26/2006 | 06/07/2006 | Zyban | CN | Drug Use for Unknown Indication | Convulsion, Drug Exposure During Pregnancy, Dry Mouth, Dyskinesia, Mood Swings | ||||
| 24 | Years | F | 6150545 | 5131402 | 10/20/2006 | Bupropion | OT | Depression | Caesarean Section, Diabetes Mellitus Inadequate Control, Drug Exposure During Pregnancy | |||||
| 24 | Years | F | 6370184 | 5400358 | 07/30/2007 | Bupropion | OT | Major Depression | Cervical Incompetence, Delivery, Gestational Diabetes | |||||
| 25 | Years | F | 5778688 | 4640251 | 04/20/2005 | Bupropion | OT | Deficiency Anaemia, Gastrointestinal Infection, Polyhydramnios | ||||||
| 25 | Years | F | 5778688 | 4673418 | 05/25/2005 | Bupropion | OT | Deficiency Anaemia, Gastrointestinal Infection, Polyhydramnios | ||||||
| 25 | Years | F | 5778688 | 4699282 | 06/24/2005 | Bupropion | OT | Deficiency Anaemia, Gastrointestinal Infection, Polyhydramnios | ||||||
| 25 | Years | F | 5778688 | 4862523 | 12/21/2005 | Bupropion | OT | Major Depression | Deficiency Anaemia, Gastrointestinal Infection, Polyhydramnios, Suicidal Ideation | |||||
| 25 | Years | F | 5981647 | 4907994 | 02/10/2006 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Hellp Syndrome, Pre-Eclampsia | |||||
| 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 | 6096342 | 5067781 | 08/02/2006 | Bupropion | OT | Major Depression | Abortion Spontaneous, Viral Infection | |||||
| 26 | Years | F | 6495578 | 5551080 | 12/12/2007 | Wellbutrin | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 26 | Years | F | 5724641 | 4563332 | 01/28/2005 | Bupropion | OT | Dizziness, Drug Exposure During Pregnancy, Feeling Abnormal | ||||||
| 26 | Years | F | 6000982 | 4938300 | 03/09/2006 | Bupropion | OT | Depression | Drug Exposure During Pregnancy, Hypertension, Umbilical Cord Vascular Disorder | |||||
| 26 | Years | F | 6000982 | 4946552 | 03/17/2006 | Bupropion | OT | Depression | Drug Exposure During Pregnancy, Hypertension, Pregnancy Induced Hypertension, Umbilical Cord Vascular Disorder | |||||
| 27 | Years | F | 4094518 | 4303872 | 02/25/2004 | Zyban | MD | Abortion Spontaneous | ||||||
| 27 | Years | F | 4094518 | 4316206 | 08/11/2003 | 03/12/2004 | Zyban | MD | Smoking Cessation Therapy | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus | ||||
| 27 | Years | F | 4101628 | 4312330 | 02/24/2004 | 03/05/2004 | Zyban | MD | Abortion Spontaneous | |||||
| 27 | Years | F | 5699542 | 4533691 | 12/21/2004 | Bupropion | OT | Smoking Cessation Therapy | Abortion Induced, Drug Exposure During Pregnancy | |||||
| 27 | Years | F | 5988089 | 4917381 | 02/21/2006 | Wellbutrin | OT | Major Depression | Abortion Induced | |||||
| 27 | Years | F | 6106117 | 5079157 | 08/14/2006 | Bupropion | CN | Depression | Abortion Induced | |||||
| 27 | Years | F | 6308848 | 5321449 | 05/10/2007 | Bupropion | OT | Major Depression | Abortion Induced | |||||
| 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 | 4011322 | 4279455 | 07/01/2002 | 01/27/2004 | Wellbutrin | MD | Depression | Chorioamnionitis, Dizziness, Drug Exposure During Pregnancy, Fatigue, Stillbirth | ||||
| 28 | Years | F | 4173428 | 4404727 | 07/22/2004 | Bupropion | OT | Depression | Abortion Spontaneous | |||||
| 28 | Years | F | 4184741 | 4608469 | 04/13/2004 | 03/15/2005 | Wellbutrin | CN | Depression | Balance Disorder, Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Electric Shock, Formication, Lethargy, Nausea, Paraesthesia, Peripheral Coldness, Premature Baby, Premature Labour | ||||
| 28 | Years | F | 5701387 | 4536189 | 09/17/2004 | 12/23/2004 | Bupropion | OT | Depression | Drug Exposure During Pregnancy, Premature Rupture of Membranes, Stillbirth | ||||
| 28 | Years | F | 6086282 | 5056130 | 07/20/2006 | Bupropion | OT | Major Depression | Abortion Induced, Drug Exposure During Pregnancy, Intra-Uterine Death | |||||
| 28 | Years | F | 6336575 | 5362295 | 06/19/2007 | Bupropion | OT | Major Depression | Antepartum Haemorrhage, Drug Exposure During Pregnancy | |||||
| 28 | Years | F | 6487275 | 5541760 | 12/10/2007 | Wellbutrin | CN | Depression | Delivery, Induced Labour, Pre-Eclampsia | |||||
| 28 | Years | F | 6487275 | 5734843 | 11/01/2001 | 05/12/2008 | Wellbutrin | CN | Depression | Complication of Delivery, Delivery, Induced Labour, Pre-Eclampsia | ||||
| 29 | Years | F | 6030852 | 5222773 | 01/29/2007 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Hypothyroidism | |||||
| 29 | Years | F | 6225324 | 5221958 | 01/29/2007 | Wellbutrin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy | |||||
| 29 | Years | F | 5733431 | 4608824 | 09/12/2004 | 03/15/2005 | Wellbutrin | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 29 | Years | F | 6030852 | 4980414 | 04/24/2006 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Hypothyroidism | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 29 | Years | F | 6030852 | 4996889 | 05/09/2006 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Hypothyroidism | |||||
| 29 | Years | F | 6127787 | 5104847 | 09/14/2006 | Wellbutrin | CN | Depression | Dehydration, Drug Exposure During Pregnancy, Drug Ineffective, Nausea, Thyroid Function Test Abnormal, Vomiting | |||||
| 29 | Years | F | 6168385 | 5151311 | 11/15/2006 | Wellbutrin | CN | Anxiety | Anxiety, Dyspnoea, Premature Labour, Tremor | |||||
| 30 | Years | F | 4122698 | 4335678 | 04/09/2004 | Wellbutrin | OT | Depression | Abortion Spontaneous | |||||
| 30 | Years | F | 4163165 | 4388722 | 06/25/2004 | 07/01/2004 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Placental Insufficiency | ||||
| 30 | Years | F | 4163165 | 4547434 | 06/25/2004 | 01/07/2005 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Placental Insufficiency, Pre-Eclampsia | ||||
| 30 | Years | F | 4163165 | 4605917 | 06/25/2004 | 03/11/2005 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Placental Insufficiency, Pre-Eclampsia | ||||
| 30 | Years | F | 4223517 | 4484242 | 06/14/2004 | 10/25/2004 | Zyban | MD | Abortion Induced, Drug Exposure During Pregnancy, Drug Ineffective | |||||
| 30 | Years | F | 5740551 | 4584878 | 08/22/2004 | 02/17/2005 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Headache | ||||
| 30 | Years | F | 5817635 | 4688818 | 06/13/2005 | Bupropion | OT | Abortion Spontaneous | ||||||
| 30 | Years | F | 5957772 | 4876519 | 01/10/2006 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 30 | Years | F | 5957772 | 4877560 | 01/11/2006 | Wellbutrin | OT | 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 | ||||
| 30 | Years | F | 5985064 | 4912591 | 02/15/2006 | Bupropion | OT | Depression | Cervical Incompetence, Cervix Cerclage Procedure, Drug Exposure During Pregnancy, Gestational Diabetes | |||||
| 30 | Years | F | 6054670 | 5013366 | 04/01/2006 | 05/30/2006 | Wellbutrin | CN | Depression | Agitation, Drug Exposure During Pregnancy, Foetal Movements Decreased, Insomnia | ||||
| 30 | Years | F | 6093328 | 5064683 | 05/01/2006 | 07/28/2006 | Wellbutrin | OT | Drug Exposure During Pregnancy, Multiple Sclerosis | |||||
| 30 | Years | F | 6093328 | 5278575 | 05/01/2006 | 03/28/2007 | Wellbutrin | OT | Bipolar I Disorder | Drug Exposure During Pregnancy, Multiple Sclerosis, Partial Seizures | ||||
| 31 | Years | F | 4223517 | 4467311 | 06/14/2004 | 10/06/2004 | Zyban | CN | Abortion Induced, Drug Exposure During Pregnancy, Drug Ineffective | |||||
| 31 | Years | F | 5757634 | 4607758 | 03/14/2005 | Wellbutrin | OT | Abortion Spontaneous | ||||||
| 31 | Years | F | 5757634 | 4619138 | 03/25/2005 | Wellbutrin | OT | Smoking Cessation Therapy | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 6271915 | 5277097 | 03/27/2007 | Bupropion | CN | Major Depression | Abortion Induced | |||||
| 32 | Years | F | 5860158 | 4737348 | 08/05/2005 | Wellbutrin | MD | Major Depression | Caesarean Section, Drug Exposure During Pregnancy, Pregnancy Induced Hypertension | |||||
| 32 | Years | F | 5905101 | 4804392 | 10/20/2005 | Bupropion | OT | Major Depression | Drug Exposure During Pregnancy, Pregnancy Induced Hypertension | |||||
| 32 | Years | F | 5942084 | 4854746 | 12/15/2005 | Bupropion | OT | Borderline Personality Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 32 | Years | F | 6091420 | 5062345 | 07/26/2006 | Wellbutrin | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Gestational Diabetes, Induced Labour | |||||
| 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 | 6135487 | 5114089 | 09/25/2006 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 32 | Years | F | 6257233 | 5259932 | 03/09/2007 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 32 | Years | F | 6487286 | 5541771 | 12/10/2007 | Wellbutrin | OT | Depression | Drug Exposure During Pregnancy, Live Birth, Nephrolithiasis, Urinary Tract Infection | |||||
| 33 | Years | F | 6209372 | 5200084 | 01/05/2007 | Wellbutrin | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 33 | Years | F | 6487285 | 5541770 | 12/10/2007 | Wellbutrin | CN | Depression | Delivery, Depressive Symptom, Pregnancy Induced Hypertension | |||||
| 33 | Years | F | 6541403 | 5611002 | 02/01/2008 | Bupropion | OT | Fibromyalgia | Abortion of Ectopic Pregnancy, Drug Exposure During Pregnancy | |||||
| 33 | Years | F | 4038054 | 4295075 | 09/01/2003 | 02/16/2004 | Wellbutrin | OT | Ill-Defined Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 33 | Years | F | 4038054 | 4399514 | 09/01/2003 | 07/16/2004 | Wellbutrin | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 33 | Years | F | 4109720 | 4319737 | 03/19/2004 | Bupropion | CN | Depression | Antepartum Haemorrhage, Drug Exposure During Pregnancy | |||||
| 33 | Years | F | 4122701 | 4335681 | 04/09/2004 | Bupropion | OT | Depression | Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal | |||||
| 33 | Years | F | 4122701 | 4546485 | 01/06/2005 | Bupropion | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal, Ultrasound Antenatal Screen Abnormal | |||||
| 33 | Years | F | 4127208 | 4341163 | 03/08/2004 | 04/19/2004 | Zyban | CN | Ex-Smoker | 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 | ||||
| 33 | Years | F | 4182585 | 4416362 | 08/05/2004 | Bupropion | OT | Depression | Abortion Spontaneous | |||||
| 33 | Years | F | 4182585 | 4627135 | 04/05/2005 | Wellbutrin | OT | Drug Exposure During Pregnancy, Growth Retardation, Intra-Uterine Death | ||||||
| 33 | Years | F | 5767238 | 4621909 | 01/01/2005 | 03/29/2005 | Zyban | MD | Abortion Induced, Drug Exposure During Pregnancy | |||||
| 33 | Years | F | 5842694 | 4720720 | 07/21/2005 | Wellbutrin | OT | Depression | Abortion Spontaneous | |||||
| 33 | Years | F | 5842694 | 4828161 | 11/15/2005 | Wellbutrin | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 33 | Years | F | 6036814 | 4990260 | 05/03/2006 | Wellbutrin | CN | Depression | Abortion Spontaneous, Alopecia, Drug Exposure During Pregnancy | |||||
| 34 | Years | F | 4130998 | 4348343 | 04/27/2004 | Zyban | MD | Abortion Spontaneous, Foetal Growth Retardation | ||||||
| 34 | Years | F | 6113473 | 5086574 | 08/23/2006 | Wellbutrin | MD | Depression | Antepartum Haemorrhage, Bleeding Peripartum, Gestational Diabetes | |||||
| 35 | Years | F | 6591601 | 5677155 | 03/24/2008 | Bupropion | OT | Major Depression | Abortion Induced, Drug Exposure During Pregnancy | |||||
| 35 | Years | F | 4069362 | 4277424 | 12/28/2003 | 01/22/2004 | Zyban | MD | Abortion Spontaneous | |||||
| 35 | Years | F | 5936083 | 4845839 | 12/06/2005 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 35 | Years | F | 6166450 | 5149228 | 11/13/2006 | Wellbutrin | CN | 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 | ||||
| 35 | Years | F | 6591601 | 5690774 | 04/01/2008 | Bupropion | OT | Major Depression | Abortion Induced, Drug Exposure During Pregnancy | |||||
| 35 | Years | F | 6251249 | 5253120 | 03/01/2007 | Bupropion | OT | Major Depression | Abortion Induced, Drug Exposure During Pregnancy, Ectopic Pregnancy | |||||
| 35 | Years | F | 6374930 | 5405283 | 08/03/2007 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 36 | Years | F | 5667255 | 4471022 | 12/12/2003 | 10/11/2004 | Bupropion | OT | Depression | Abortion Spontaneous | ||||
| 36 | Years | F | 5708277 | 4544158 | 10/01/2004 | 01/04/2005 | Zyban | MD | Smoking Cessation Therapy | Drug Ineffective, Drug Interaction | ||||
| 36 | Years | F | 5708277 | 4565514 | 10/01/2004 | 01/31/2005 | Zyban | MD | Smoking Cessation Therapy | Abortion Induced, Drug Exposure During Pregnancy, Drug Ineffective, Drug Interaction | ||||
| 36 | Years | F | 5810214 | 4679353 | 06/02/2005 | Bupropion | OT | Abortion Induced | ||||||
| 36 | Years | F | 5810214 | 4698147 | 06/23/2005 | Wellbutrin | OT | Abortion Induced, Stillbirth | ||||||
| 36 | Years | F | 5810214 | 4736858 | 08/08/2005 | Wellbutrin | OT | Major Depression | Abortion Induced, Stillbirth | |||||
| 36 | Years | F | 5861410 | 4745923 | 08/16/2005 | Bupropion | OT | Major Depression | Acne, Drug Exposure During Pregnancy, Uterine Contractions During Pregnancy | |||||
| 36 | Years | F | 5861410 | 4815761 | 10/31/2005 | Wellbutrin | OT | Bipolar Disorder | Acne, Bed Rest, Caesarean Section, Drug Exposure During Pregnancy, Uterine Contractions During Pregnancy | |||||
| 36 | Years | F | 5861410 | 4881946 | 01/17/2006 | Wellbutrin | OT | Bipolar Disorder | Acne, Drug Exposure During Pregnancy, Haemangioma, Uterine Contractions 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 | ||||
| 36 | Years | F | 5861410 | 4975170 | 04/18/2006 | Wellbutrin | OT | Bipolar Disorder | Acne, Drug Exposure During Pregnancy, Haemangioma Congenital, Uterine Contractions During Pregnancy | |||||
| 36 | Years | F | 5869505 | 4756212 | 02/01/2005 | 08/30/2005 | Wellbutrin | CN | Anxiety | Feeling Jittery, Insomnia, Weight Decreased | ||||
| 36 | Years | F | 5869505 | 4924048 | 02/01/2005 | 02/27/2006 | Wellbutrin | CN | Anxiety | Anxiety, Drug Administration Error, Drug Exposure During Pregnancy, Feeling Jittery, Insomnia, Weight Decreased | ||||
| 36 | Years | F | 5967400 | 4889621 | 01/24/2006 | Bupropion | OT | Major Depression | Abortion Missed, Drug Exposure During Pregnancy, Intra-Uterine Death | |||||
| 36 | Years | F | 6061960 | 5022268 | 06/09/2006 | Bupropion | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 36 | Years | F | 6325595 | 5344104 | 02/20/2007 | 06/04/2007 | Zyban | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 37 | Years | F | 6218450 | 5213173 | 01/19/2007 | Wellbutrin | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 37 | Years | F | 4117611 | 4329741 | 03/01/2004 | 04/01/2004 | Wellbutrin | OT | Depression | Abortion Spontaneous | ||||
| 37 | Years | F | 5859381 | 4743737 | 12/02/2004 | 08/12/2005 | Zyban | OT | Abortion Spontaneous | |||||
| 37 | Years | F | 5932481 | 4841551 | 09/01/2004 | 11/30/2005 | Wellbutrin | CN | Depression | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk | ||||
| 37 | Years | F | 6088001 | 5058110 | 07/21/2006 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 38 | Years | F | 4123469 | 4336661 | 04/12/2004 | Wellbutrin | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Weight Increased | |||||
| 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 | 4151233 | 4373279 | 01/01/2003 | 06/08/2004 | Zyban | MD | Smoking Cessation Therapy | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 21 | ||||
| 38 | Years | F | 4159172 | 4384409 | 11/01/2003 | 06/24/2004 | Bupropion | OT | Depression | Abortion Spontaneous | ||||
| 38 | Years | F | 4220076 | 4464189 | 09/19/2004 | 10/01/2004 | Wellbutrin | MD | Depression | Abortion Spontaneous, Vaginal Haemorrhage | ||||
| 38 | Years | F | 4220076 | 4471020 | 09/19/2004 | 10/11/2004 | Wellbutrin | MD | Depression | Abortion Spontaneous, Vaginal Haemorrhage | ||||
| 38 | Years | F | 6244120 | 5245298 | 02/23/2007 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 39 | Years | F | 6068617 | 5029919 | 06/20/2006 | Wellbutrin | CN | Major Depression | Drug Exposure During Pregnancy, Uterine Contractions Abnormal | |||||
| 39 | Years | F | 6068617 | 5101394 | 09/11/2006 | Wellbutrin | CN | Major Depression | Uterine Contractions Abnormal | |||||
| 39 | Years | F | 6189995 | 5177020 | 12/18/2006 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 39 | Years | F | 6189995 | 5253102 | 03/01/2007 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 40 | Years | F | 4144643 | 4397309 | 05/11/2004 | 07/14/2004 | Wellbutrin | MD | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy, Vaginal Haemorrhage | ||||
| 40 | Years | F | 5900445 | 4798856 | 10/14/2005 | Bupropion | CN | Major Depression | Abortion Induced, Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal | |||||
| 40 | Years | F | 6121263 | 5095981 | 09/05/2006 | Bupropion | OT | 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 | ||||
| 40 | Years | F | 6125883 | 5200987 | 01/08/2007 | Wellbutrin | CN | Depression | Caesarean Section, Drug Exposure During Pregnancy, Placental Disorder, Small for Dates Baby | |||||
| 40 | Years | F | 6153147 | 5134613 | 10/25/2006 | Wellbutrin | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 41 | Years | F | 4091448 | 4299469 | 01/12/2004 | 02/19/2004 | Wellbutrin | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Overdose, Suicide Attempt | ||||
| 41 | Years | F | 4091448 | 4322728 | 01/12/2004 | 03/24/2004 | Wellbutrin | OT | Depression | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Overdose, Suicide Attempt | ||||
| 41 | Years | F | 4146422 | 4366595 | 01/01/2004 | 05/27/2004 | Zyban | CN | Abortion Spontaneous, Necrobiosis, Placental Disorder | |||||
| 41 | Years | F | 6004175 | 4942982 | 03/08/2006 | 03/14/2006 | Wellbutrin | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 42 | Years | F | 6179636 | 5164729 | 12/05/2006 | Bupropion | OT | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 43 | Years | F | 4138550 | 4357038 | 08/22/2003 | 05/12/2004 | Bupropion | OT | Depression | Abortion Spontaneous | ||||
| 43 | Years | F | 5785788 | 4649091 | 03/14/2005 | 04/29/2005 | Bupropion | OT | Abortion Spontaneous | |||||
| 43 | Years | F | 5915421 | 4817002 | 11/01/2005 | Bupropion | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 43 | Years | F | 6171340 | 5155086 | 11/04/2006 | 11/21/2006 | Bupropion | MD | Depression | Abdominal Pain, Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 43 | Years | F | 6171340 | 5188262 | 11/04/2006 | 12/21/2006 | Bupropion | MD | Depression | Abdominal Pain, 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 | ||||
| 43 | Years | F | 6171340 | 5424963 | 11/04/2006 | 08/24/2007 | Bupropion | MD | Depression | Abdominal Pain, Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 44 | Years | F | 4138550 | 4367114 | 04/01/2003 | 05/28/2004 | Bupropion | OT | Depression | Abortion Spontaneous | ||||
| 44 | Years | F | 4147056 | 4367122 | 08/22/2003 | 05/28/2004 | Bupropion | OT | Depression | Abortion Spontaneous, Multiple Sclerosis | ||||
| 44 | Years | F | 6004184 | 4942991 | 03/14/2006 | Bupropion | CN | Depression | Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal | |||||
| 36 Males | 179 Females | 252 Cases (Gender was not reported for 37 Cases) | 328 Individual Safety Reports | |||||||||||
Bupropion (bupropion), Wellbutrin (bupropion), Zyban (bupropion)
Abdominal Pain, Abdominal Tenderness, Abdominal Transposition, Abdominal Wall Anomaly, Abortion, Abortion Induced, Abortion Missed, Abortion of Ectopic Pregnancy, Abortion Spontaneous, Acne, Affect Lability, Affective Disorder, Agitation, Alopecia, Alpha 1 Foetoprotein Abnormal, Amnesia, Amniotic Fluid Volume Decreased, Anencephaly, Anorexia, Antepartum Haemorrhage, Anxiety, Aorta Hypoplasia, Aortic Valve Stenosis, Apnoea, Arteriopathic Disease, Arthralgia, Asperger's Disorder, Asphyxiating Thoracic Dystrophy, Asthma, Atrial Septal Defect, Atrioventricular Septal Defect, Attention Deficit/Hyperactivity Disorder, Autosomal Chromosome Anomaly, Balance Disorder, Bed Rest, Bicuspid Aortic Valve, Bipolar Disorder, Bleeding Peripartum, Blood Bicarbonate Increased, Blood Bilirubin Increased, Brain Stem Syndrome, Bruxism, Caesarean Section, Campbell De Morgan Spots, Cardiac Murmur, Cardio-Respiratory Arrest, Cervical Incompetence, Cervix Cerclage Procedure, Chills, Chorioamnionitis, Chromosomal Deletion, Chromosome Abnormality, Cleft Palate, Coloboma, Colostomy, Completed Suicide, Complication of Delivery, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Anomaly, Congenital Atrial Septal Defect, Congenital Eye Disorder, Congenital Hand Malformation, C-Reactive Protein Increased, Convulsion, Convulsion Neonatal, Cough, Cri Du Chat Syndrome, Cryptophthalmos, Cryptorchism, Cyanosis, Death Neonatal, Deficiency Anaemia, Dehydration, Delivery, Depression, Depressive Symptom, Dermatitis Diaper, Dextrocardia, Diabetes Mellitus Inadequate Control, Diaphragmatic Hernia, Diarrhoea, Disorientation, Dizziness, Double Ureter, Drug Administration Error, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Withdrawal Syndrome, Dry Mouth, Dyskinesia, Dyspepsia, Dysphagia, Dyspnoea, Ear Disorder, Ear Malformation, Eclampsia, Ectopic Pregnancy, Electric Shock, Electrocardiogram QT Prolonged, Encephalopathy, Erythema, Face Oedema, Failure To Thrive, Fallot's Tetralogy, Fatigue, Febrile Convulsion, Feeling Abnormal, Feeling Jittery, Foetal Arrhythmia, Foetal Disorder, Foetal Growth Retardation, Foetal Heart Rate Abnormal, Foetal Malformation, Foetal Movements Decreased, Formication, Fungal Infection, Gastroenteritis, Gastrointestinal Disorder, Gastrointestinal Infection, Gastrooesophageal Reflux Disease, General Physical Health Deterioration, Gestational Diabetes, Grand Mal Convulsion, Growth Retardation, Haemangioma, Haemangioma Congenital, Headache, Heart Disease Congenital, Hellp Syndrome, Hernia Congenital, Hydrocele, Hyperbilirubinaemia, Hypertension, Hypospadias, Hypothyroidism, Ileal Perforation, Induced Labour, Infantile Apnoeic Attack, Infection, Inguinal Hernia, Insomnia, Intentional Overdose, Intra-Uterine Death, Irritability, Isoimmunisation, Jaundice, Jaundice Neonatal, Jaw Fracture, Joint Swelling, Kidney Malformation, Kyphosis, Lacrimation Increased, Laryngomalacia, Lethargy, Life Support, Limb Deformity, Live Birth, Liver Disorder, Loss of Consciousness, Lymphangiectasia, Macrognathia, Mania, Maternal Drugs Affecting Foetus, Memory Impairment, Metrorrhagia, Micrognathia, Microphthalmos, Microtia, Milk Allergy, Mitral Valve Stenosis, Mobility Decreased, Mood Swings, Multiple Sclerosis, Myocardial Infarction, Nausea, Neck Pain, Necrobiosis, Necrotising Colitis, Neonatal Aspiration, Neonatal Disorder, Nephrolithiasis, Nervous System Disorder, Nervousness, Neutrophil Percentage Increased, Nose Deformity, Ocular Icterus, Odynophagia, Oedema, Overdose, Painful Response To Normal Stimuli, Paraesthesia, Partial Seizures, Patent Ductus Arteriosus, Pectus Excavatum, Peripheral Coldness, Pharmaceutical Product Complaint, Placental Disorder, Placental Insufficiency, Polyhydramnios, Poor Weight Gain Neonatal, Postictal State, Posture Abnormal, Pre-Eclampsia, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Pulmonary Hypertension, Pulmonary Oedema, Pulmonary Valve Stenosis Congenital, Pyrexia, Rectal Haemorrhage, Renal Disorder, Respiratory Distress, Restlessness, Rhinorrhoea, Sensory Disturbance, Skin Exfoliation, Sleep Disorder, Small for Dates Baby, Somnolence, Speech Disorder, Spleen Malformation, Staphylococcal Scalded Skin Syndrome, Staring, Stillbirth, Stress, Stridor, Sudden Infant Death Syndrome, Suicidal Ideation, Suicide Attempt, Tachycardia, Talipes, Thinking Abnormal, Thrombocytopenia Neonatal, Thyroid Disorder, Thyroid Function Test Abnormal, Tongue Biting, Transmission of Drug Via Semen, Transposition of the Great Vessels, Traumatic Delivery, Tremor, Trisomy 15, Trisomy 18, Trisomy 21, Ultrasound Antenatal Screen Abnormal, Umbilical Cord Abnormality, Umbilical Cord Vascular Disorder, Upper Respiratory Tract Infection, Urinary Tract Infection, Urticaria, Uterine Contractions Abnormal, Uterine Contractions During Pregnancy, Vaginal Haemorrhage, Ventricular Septal Defect, Vesicoureteric Reflux, Viral Infection, Viral Upper Respiratory Tract Infection, Vocal Cord Paralysis, Vomiting, Weight Decreased, Weight Increased, White Blood Cell Count Increased, Withdrawal Syndrome
| Bupropion 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. |
| Anencephaly | Congenital absence of most of the brain and spinal cord. [Images] |
| Anomaly | Something that deviates from what is standard, normal or expected (Abdominal Wall Anomaly, Congenital Anomaly). |
| Anorexia | Loss of appetite, especially as a result of disease. |
| Atrial Septal Defect | An atrial septal defect (ASD), a congenital defect, occurs when there is an opening in the atrial septum, or dividing wall between the two upper chambers of the heart, known as the right and left atria.Normally, oxygen-poor (blue) blood returns to the right atrium from the body, travels to the right ventricle, then is pumped into the lungs where it receives oxygen. Oxygen-rich (red) blood returns to the left atrium from the lungs, passes into the left ventricle, then is pumped out to the body through the aorta. An atrial septal defect allows oxygen-rich (red) blood to pass from the left atrium through the opening in the septum, and then mix with oxygen-poor (blue) blood in the right atrium. This heart defect can cause lung problems if not repaired. When blood passes through the ASD from the left atrium to the right atrium, a larger volume of blood than normal must be handled by the right side of the heart, causing the right side to become overworked and enlarged. Extra blood then passes through the pulmonary artery into the lungs, causing higher pressure than normal in the blood vessels in the lungs, a condition known as pulmonary hypertension. |
| Coloboma | An anomaly of the eye, usually a developmental defect, that often results in some loss of vision. [Images] |
| 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. Drug Withdrawal Syndrome Neonatal). |
| Drug Withdrawal Syndrome | 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. |
| Fallot's Tetralogy | A congenital malformation of the heart characterized by a defect in the ventricular septum, misplacement of the origin of the aorta, narrowing of the pulmonary artery, and enlargement of the right ventricle. [Images] |
| 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. | |
| Grand Mal Convusion | A severe form of epilepsy characterized by seizures involving spasms and loss of consciousness. |
| Hypospadias | A congenital anomaly in male babies 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), or a congenital anomaly in female babies in which the urethra opens into the vagina. [Images] |
| Paraesthesia | A skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause. |
| 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). |
| Transposition of the Great Vessels | In transposition of the great arteries (vessels), the aorta and pulmonary artery are reversed. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen.Likewise, the pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs. All patients with transposition of the great arteries require surgery early in life to survive. The surgical procedure enlarges a naturally occurring connection between the right and left upper chambers (the atria). This lets the blood mix so some oxygen-rich and oxygen-poor blood can be pumped to the correct side. |
| Trisomy | A condition in which an extra copy of a chromosome is present in the cell nuclei, causing developmental abnormalities. |
| Trisomy 15 | Trisomy 15 is rare. Most cases end as an early miscarriage. In cases that have progressed in development, abnormalities of the facial and cranial features, hands, and feet are described. Growth retardation occurs later in pregnancy. Chromsome 15 is linked to Prader Willi syndrome (obesity, mental retardation, and anomalous physical appearance). |
| 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. [Images] |
| 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. [Images] |
| Ventricular Septal Defect | A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle). The hole allows blood to flow from the left ventricle to the right ventricle instead of entering the aorta for distribution throughout the body. This blood recycles through the lungs before returning to the left ventricle. This results in less oxygenated blood reaching the body. If the hole is sufficiently large, the lack of oxygen being delivered to the body can cause severe problems, including heart failure and breathlessness. |
| Vesicoureteric Reflux | Vesicoureteral reflux (VUR) is a congenital defect in which normal compression of the bladder during urination results in an abnormal backflow of urine into the kidneys. Over a period of weeks, months or years, this leads to kidney infection, permanent scarring of kidney tissue, high blood pressure, and if left untreated, renal failure. |
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 Bupropion 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".