Bupropion - Congenital, Prenatal & Neonatal Adverse Rections


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

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

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



Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 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

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

Bupropion (bupropion), Wellbutrin (bupropion), Zyban (bupropion)

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

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 Reporting by Consumers

MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking 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".