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Index of reports
> Cases with Foetal Exposure During Pregnancy (6)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zonegran (Zonisamide) where reactions include foetal exposure during pregnancy. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Zonegran side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-30
Patient: female, weighing 3.0 kg (6.5 pounds)
Reactions: Microcephaly, Anorectal Disorder, Hypoglycaemia, Foetal Exposure During Pregnancy, Kidney Malformation, Anal Atresia, Epilepsy, Congenital Tracheomalacia
Drug(s) suspected as cause:
Clobazam
Dosage: unk ukn, unk
Indication: Epilepsy
Zonegran
Dosage: unk ukn, unk
Indication: Epilepsy
Phenobarbital TAB
Dosage: unk ukn, unk
Indication: Epilepsy
Carbamazepine
Dosage: unk ukn, unk
Indication: Epilepsy
Possible Zonegran side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-25
Patient: female, weighing 3.0 kg (6.5 pounds)
Reactions: Microcephaly, Anorectal Disorder, Hypoglycaemia, Foetal Exposure During Pregnancy, Kidney Malformation, Anal Atresia, Epilepsy, Congenital Tracheomalacia
Drug(s) suspected as cause:
Carbamazepine
Dosage: unk ukn, unk
Indication: Epilepsy
Clobazam
Dosage: unk ukn, unk
Indication: Epilepsy
Zonegran
Dosage: unk ukn, unk
Indication: Epilepsy
Phenobarbital TAB
Dosage: unk ukn, unk
Indication: Epilepsy
Possible Zonegran side effects in male
Reported by a physician from France on 2012-01-31
Patient: male
Reactions: Foetal Anticonvulsant Syndrome, Foetal Exposure During Pregnancy, Congenital Foot Malformation, Drug Withdrawal Syndrome Neonatal, Convulsion Neonatal
Drug(s) suspected as cause:
Phenobarbital TAB
Indication: Maternal Exposure Timing Unspecified
Keppra
Indication: Maternal Exposure Timing Unspecified
Zonegran
Indication: Maternal Exposure Timing Unspecified
Valproic Acid
Indication: Maternal Exposure Timing Unspecified
Frisium
Indication: Maternal Exposure Timing Unspecified
Possible Zonegran side effects in male
Reported by a physician from France on 2012-01-25
Patient: male
Reactions: Foetal Anticonvulsant Syndrome, Maternal Drugs Affecting Foetus, Foetal Exposure During Pregnancy, Congenital Foot Malformation, Drug Withdrawal Syndrome Neonatal, Convulsion Neonatal
Drug(s) suspected as cause:
Valproic Acid
Indication: Maternal Exposure Timing Unspecified
Phenobarbital TAB
Indication: Maternal Exposure Timing Unspecified
Frisium
Indication: Maternal Exposure Timing Unspecified
Zonegran
Indication: Maternal Exposure Timing Unspecified
Keppra
Indication: Maternal Exposure Timing Unspecified
Possible Zonegran side effects in male
Reported by a lawyer from Denmark on 2012-01-18
Patient: male
Reactions: Foetal Exposure During Pregnancy, Congenital Foot Malformation, Epilepsy Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Frisium
Indication: Epilepsy
Depakene
Indication: Epilepsy
Keppra
Dosage: 4000 mg
Indication: Epilepsy
Zonegran
Dosage: 200 mg
Indication: Epilepsy
Phenobarbital TAB
Dosage: 180 mg
Indication: Epilepsy
Possible Zonegran side effects in female
Reported by a physician from France on 2011-11-10
Patient: female
Reactions: Foetal Growth Restriction, Foetal Exposure During Pregnancy, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Urbanyl
Dosage: 10mg twice per day
Indication: Epilepsy
Lamictal
Dosage: 150mg twice per day
Indication: Epilepsy
Zonegran
Dosage: 100mg twice per day
Indication: Epilepsy
Other drugs received by patient: Oestroprogestative Contraception; Celestone
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