Index of reports
> Cases with Cleft LIP and Palate (47)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Topamax (Topiramate) where reactions include cleft lip and palate. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 47 Next >>
Possible Topamax side effects in female
Reported by a lawyer from United States on 2012-08-24
Patient: female
Reactions: Speech Disorder, Cleft LIP and Palate, Foetal Growth Restriction, Foetal Heart Rate Abnormal, Otitis Media Chronic, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Hydroxyzine
Indication: Foetal Exposure During Pregnancy
Zoloft
Indication: Foetal Exposure During Pregnancy
Trazodone Hydrochloride
Indication: Foetal Exposure During Pregnancy
Ibuprofen
Indication: Foetal Exposure During Pregnancy
Fentanyl
Indication: Foetal Exposure During Pregnancy
Effexor
Indication: Foetal Exposure During Pregnancy
Colace
Indication: Foetal Exposure During Pregnancy
Bupivacaine HCL
Indication: Foetal Exposure During Pregnancy
Ibuprofen
Terbutaline
Indication: Foetal Exposure During Pregnancy
Oxytocin
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Mirtazapine
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Multi-Vitamins; Metformin HCL; Risedronate Sodium; Folic Acid; Ferrous Sulfate TAB
Possible Topamax side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: female
Reactions: Cleft LIP and Palate, Cardiac Murmur, Nose Deformity, Developmental Delay, Hypertelorism of Orbit, Emotional Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lamictal
Indication: Foetal Exposure During Pregnancy
Misoprostol
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Acetaminophen
Acetaminophen
Indication: Foetal Exposure During Pregnancy
Phenobarbital TAB
Indication: Foetal Exposure During Pregnancy
Loratadine
Indication: Foetal Exposure During Pregnancy
Butorphanol Tartrate
Indication: Foetal Exposure During Pregnancy
Nasonex
Indication: Foetal Exposure During Pregnancy
Prevacid
Indication: Foetal Exposure During Pregnancy
Promethazine HCL
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Multi-Vitamins; Ferrous Gluconate
Possible Topamax side effects in
Reported by a lawyer from United States on 2012-08-10
Patient:
Reactions: Atrial Septal Defect, Cleft LIP and Palate, Patent Ductus Arteriosus
Drug(s) suspected as cause:
Topamax
Possible Topamax side effects in male
Reported by a lawyer from United States on 2012-08-09
Patient: male
Reactions: Cleft LIP and Palate, Cataract, Pneumonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Other drugs received by patient: Multi-Vitamins
Possible Topamax side effects in female
Reported by a lawyer from United States on 2012-07-30
Patient: female
Reactions: Cleft LIP and Palate, Hyperbilirubinaemia, Hydronephrosis, Premature Baby, Hyperkalaemia, Otitis Media Chronic, Small FOR Dates Baby, Autism Spectrum Disorder, Heart Disease Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Neurontin
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Phenobarbital TAB
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Vitamin
Possible Topamax side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27
Patient: female
Reactions: Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Amniotic Band Syndrome, Premature Baby, Anophthalmos, Bicuspid Aortic Valve, Cryptophthalmos, Tongue Disorder, Heart Disease Congenital, Microphthalmos, Optic Nerve Hypoplasia, Pterygium Colli
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Midrin
Indication: Foetal Exposure During Pregnancy
Topamax
Migquin
Indication: Foetal Exposure During Pregnancy
Start date: 2005-10-24
Topamax
Indication: Foetal Exposure During Pregnancy
Topamax
Start date: 2005-10-21
Nitrofurantoin
Indication: Foetal Exposure During Pregnancy
Start date: 2005-11-29
Topamax
Possible Topamax side effects in female
Reported by a lawyer from United States on 2012-07-26
Patient: female
Reactions: Cleft LIP and Palate, Hydronephrosis, Hyperbilirubinaemia, Autism Spectrum Disorder, Small FOR Dates Baby, Hyperkalaemia, Premature Baby, Heart Disease Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Phenobarbital TAB
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Neurontin
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Vitamin
Possible Topamax side effects in male
Reported by a lawyer from United States on 2012-07-12
Patient: male
Reactions: Cleft LIP and Palate, Cerebral Palsy, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Feeding Disorder, Hydrocele, Duane's Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Oxycodone / Acetaminophen
Indication: Foetal Exposure During Pregnancy
Nystatin
Indication: Foetal Exposure During Pregnancy
Vicodin
Indication: Foetal Exposure During Pregnancy
Acetaminophen
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Oxycontin
Indication: Foetal Exposure During Pregnancy
Ovcon-35
Indication: Foetal Exposure During Pregnancy
Ultram
Indication: Foetal Exposure During Pregnancy
Soma
Indication: Foetal Exposure During Pregnancy
Feldene
Indication: Foetal Exposure During Pregnancy
Crestor
Indication: Foetal Exposure During Pregnancy
Effexor
Indication: Foetal Exposure During Pregnancy
Selective Serotonin Reuptake Inhibitor
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL
Possible Topamax side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: female
Reactions: Cleft LIP and Palate, Foetal Growth Restriction, Speech Disorder, Otitis Media Chronic, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Hydroxyzine
Indication: Foetal Exposure During Pregnancy
Zoloft
Indication: Foetal Exposure During Pregnancy
Trazodone HCL
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Mirtazapine
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Risedronate Sodium; Folic Acid; Metformin HCL
Possible Topamax side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: female
Reactions: Cleft LIP and Palate, Hydronephrosis, Hyperbilirubinaemia, Autism Spectrum Disorder, Small FOR Dates Baby, Hyperkalaemia, Premature Baby, Heart Disease Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Neurontin
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Phenobarbital TAB
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Vitamin
Possible Topamax side effects in male
Reported by a lawyer from United States on 2012-06-29
Patient: male
Reactions: Cleft LIP and Palate, Pneumonia, Cataract
Drug(s) suspected as cause:
Topamax
Other drugs received by patient: Multi-Vitamins
Possible Topamax side effects in male
Reported by a lawyer from United States on 2012-06-22
Patient: male
Reactions: Cleft LIP and Palate, Otitis Media Chronic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Other drugs received by patient: Folic Acid; Multi-Vitamins
Possible Topamax side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: male
Reactions: Cerebral Palsy, Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Ear Infection, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Dacryostenosis Congenital, Hypermetropia, Feeding Disorder, Hydrocele, Duane's Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Oxycontin
Indication: Foetal Exposure During Pregnancy
Effexor
Indication: Foetal Exposure During Pregnancy
Vicodin
Indication: Foetal Exposure During Pregnancy
Acetaminophen
Indication: Foetal Exposure During Pregnancy
Crestor
Indication: Foetal Exposure During Pregnancy
Ovcon-35
Indication: Foetal Exposure During Pregnancy
Nystatin
Indication: Foetal Exposure During Pregnancy
Selective Serotonin Reuptake Inhibitor
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Soma
Indication: Foetal Exposure During Pregnancy
Feldene
Indication: Foetal Exposure During Pregnancy
Acetaminophen
Ultram
Indication: Foetal Exposure During Pregnancy
Oxycodone / Acetaminophen
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Leucovorin Calcium; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Fish OIL
Possible Topamax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient: male
Reactions: Cleft LIP and Palate, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Feeding Disorder, Duane's Syndrome, Hydrocele
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ovcon-35
Indication: Foetal Exposure During Pregnancy
Soma
Indication: Foetal Exposure During Pregnancy
Vicodin
Indication: Foetal Exposure During Pregnancy
Effexor
Indication: Foetal Exposure During Pregnancy
Acetaminophen
Feldene
Indication: Foetal Exposure During Pregnancy
Selective Serotonin Reuptake Inhibitor
Indication: Foetal Exposure During Pregnancy
Ultram
Indication: Foetal Exposure During Pregnancy
Oxycontin
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Oxycodone / Acetaminophen
Indication: Foetal Exposure During Pregnancy
Crestor
Indication: Foetal Exposure During Pregnancy
Nystatin
Indication: Foetal Exposure During Pregnancy
Acetaminophen
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Leucovorin Calcium; Fish OIL; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP
Possible Topamax side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: female
Reactions: Asthma, Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Meningitis Neonatal, Strabismus, Pharyngotonsillitis, Developmental Delay, Intraventricular Haemorrhage Neonatal, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Malocclusion, Abnormal Behaviour, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Attention Deficit / Hyperactivity Disorder, Sleep Apnoea Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Start date: 2001-01-01
End date: 2007-01-01
Prometrium
Indication: Foetal Exposure During Pregnancy
Nifedipine
Indication: Foetal Exposure During Pregnancy
Terbutaline
Indication: Foetal Exposure During Pregnancy
Lithium Carbonate
Indication: Foetal Exposure During Pregnancy
Clindamycin
Indication: Foetal Exposure During Pregnancy
Lexapro
Indication: Foetal Exposure During Pregnancy
Zithromax
Indication: Foetal Exposure During Pregnancy
Betamethasone
Indication: Foetal Exposure During Pregnancy
Ampicillin
Indication: Foetal Exposure During Pregnancy
Possible Topamax side effects in male
Reported by a lawyer from United States on 2012-06-08
Patient: male
Reactions: Cleft LIP and Palate, Pneumonia, Cataract, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Topamax
Other drugs received by patient: Multi-Vitamins
Possible Topamax side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient: male
Reactions: Cleft LIP and Palate, Otitis Media Chronic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Other drugs received by patient: Multi-Vitamins; Folic Acid
Possible Topamax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-06
Patient: male
Reactions: Cleft LIP and Palate, Craniosynostosis, Developmental Delay, Torticollis, Feeding Disorder, Hydrocele, Duane's Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Indication: Foetal Exposure During Pregnancy
Crestor
Indication: Foetal Exposure During Pregnancy
Feldene
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Oxycodone / Acetaminophen
Indication: Foetal Exposure During Pregnancy
Acetaminophen
Selective Serotonin Reuptake Inhibitor
Indication: Foetal Exposure During Pregnancy
Ovcon-35
Indication: Foetal Exposure During Pregnancy
Oxycontin
Indication: Foetal Exposure During Pregnancy
Vicodin
Indication: Foetal Exposure During Pregnancy
Ultram
Indication: Foetal Exposure During Pregnancy
Soma
Indication: Foetal Exposure During Pregnancy
Nystatin
Indication: Foetal Exposure During Pregnancy
Effexor
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL
Possible Topamax side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-04
Patient: male
Reactions: Cleft LIP and Palate, Craniosynostosis, Developmental Delay, Duane's Syndrome
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Crestor
Indication: Foetal Exposure During Pregnancy
Ovcon-35
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP
Possible Topamax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04
Patient: male
Reactions: Anxiety, Cleft LIP and Palate, Post-Traumatic Stress Disorder, Communication Disorder, Congenital Anomaly, Chronic Sinusitis, Depression, Attention Deficit / Hyperactivity Disorder
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Clonazepam
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Citalopram Hydrobromide
Possible Topamax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25
Patient: male
Reactions: Cleft LIP and Palate, Anxiety, Post-Traumatic Stress Disorder, Communication Disorder, Congenital Anomaly, Chronic Sinusitis, Depression, Attention Deficit / Hyperactivity Disorder
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Clonazepam
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Citalopram Hydrobromide
Possible Topamax side effects in
Reported by a lawyer from United States on 2012-04-25
Patient:
Reactions: Cleft LIP and Palate, Craniosynostosis
Drug(s) suspected as cause:
Topamax
Possible Topamax side effects in female
Reported by a physician from United States on 2012-04-19
Patient: female
Reactions: Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Premature Baby, Cryptophthalmos, Tongue Disorder, Heart Disease Congenital, Microphthalmos, Congenital Tongue Anomaly, Pterygium Colli, Optic Nerve Hypoplasia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Topamax
Start date: 2005-10-21
Migquin
Indication: Foetal Exposure During Pregnancy
Start date: 2005-10-24
Topamax
Topamax
Midrin
Indication: Foetal Exposure During Pregnancy
Nitrofurantoin
Indication: Foetal Exposure During Pregnancy
Start date: 2005-11-29
Possible Topamax side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-13
Patient: male
Reactions: Weight Decreased, Cleft LIP and Palate, Atrial Septal Defect, Maternal Drugs Affecting Foetus, Chronic Fatigue Syndrome, Urine Output Decreased, Ventricular Septal Defect, Respiratory Distress, Cystic Fibrosis, Vitamin D Decreased, Patent Ductus Arteriosus, Emotional Disorder, Feeding Disorder Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Possible Topamax side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-12
Patient: female
Reactions: Asthma, Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Meningitis Neonatal, Strabismus, Pharyngotonsillitis, Developmental Delay, Intraventricular Haemorrhage Neonatal, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Abnormal Behaviour, Malocclusion, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Sleep Apnoea Syndrome, Attention Deficit / Hyperactivity Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zithromax
Indication: Foetal Exposure During Pregnancy
Nifedipine
Indication: Foetal Exposure During Pregnancy
Terbutaline
Indication: Foetal Exposure During Pregnancy
Betamethasone
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Start date: 2001-01-01
End date: 2007-01-01
Clindamycin
Indication: Foetal Exposure During Pregnancy
Ampicillin
Indication: Foetal Exposure During Pregnancy
Lexapro
Indication: Foetal Exposure During Pregnancy
Prometrium
Indication: Foetal Exposure During Pregnancy
Lithium Carbonate
Indication: Foetal Exposure During Pregnancy
Possible Topamax side effects in female
Reported by a physician from United States on 2012-03-23
Patient: female
Reactions: Cleft LIP and Palate, Cryptophthalmos, Premature Baby, Tongue Disorder, Microphthalmos, Optic Nerve Hypoplasia
Drug(s) suspected as cause:
Topamax
Nitrofurantoin
Indication: Foetal Exposure During Pregnancy
Start date: 2005-11-29
Topamax
Indication: Foetal Exposure During Pregnancy
Start date: 2005-10-21
Topamax
Midrin
Indication: Foetal Exposure During Pregnancy
Topamax
Migquin
Indication: Foetal Exposure During Pregnancy
Start date: 2005-10-24
Possible Topamax side effects in female
Reported by a lawyer from United States on 2012-03-22
Patient: female
Reactions: Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Strabismus, Intraventricular Haemorrhage Neonatal, Developmental Delay, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Malocclusion, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Attention Deficit / Hyperactivity Disorder, Sleep Apnoea Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Start date: 2001-01-01
End date: 2007-01-01
Lithium Carbonate
Indication: Foetal Exposure During Pregnancy
Terbutaline
Indication: Foetal Exposure During Pregnancy
Lexapro
Indication: Foetal Exposure During Pregnancy
Zithromax
Indication: Foetal Exposure During Pregnancy
Prometrium
Indication: Foetal Exposure During Pregnancy
Nifedipine
Indication: Foetal Exposure During Pregnancy
Betamethasone
Indication: Foetal Exposure During Pregnancy
Clindamycin
Indication: Foetal Exposure During Pregnancy
Ampicillin
Indication: Foetal Exposure During Pregnancy
Possible Topamax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22
Patient: male, weighing 3.0 kg (6.5 pounds)
Reactions: Cleft LIP and Palate, Weight Decreased, Dysphagia, Deafness Bilateral, Failure To Thrive, Syndactyly, Nose Deformity, Feeding Disorder, Sleep Apnoea Syndrome, Inguinal Hernia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Cymbalta
Indication: Foetal Exposure During Pregnancy
Inderal
Indication: Foetal Exposure During Pregnancy
Lortab
Indication: Foetal Exposure During Pregnancy
Possible Topamax side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-20
Patient: male
Reactions: Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Social Avoidant Behaviour, Premature Baby, Micrognathia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Other drugs received by patient: Multi-Vitamins; Folic Acid; Iron; Calcium Carbonate
Possible Topamax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-13
Patient: male
Reactions: Anxiety, Cleft LIP and Palate, Post-Traumatic Stress Disorder, Communication Disorder, Congenital Anomaly, Chronic Sinusitis, Depression, Attention Deficit / Hyperactivity Disorder
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Clonazepam
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Citalopram Hydrobromide
Page 1 Next >>
|