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MotherToBaby

Medications and More during pregnancy and breastfeeding

Topiramate (Topamax®)

Selected References:  

  • Afrman JJ, et al. 2020. Therapeutic Drug Monitoring of Antiepileptic Drugs in Women with Epilepsy Before, During, and After Pregnancy. Clin Pharmacokinet, 59(4):427-445. 
  • Alsaad AMS, et al. 2015. First trimester exposure to topiramate and the risk of oral clefts in the offspring: A systematic review and meta-analysis. Reprod Toxicol, 53:45-50. 
  • Blotière PO, et al. 2020. Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy: a French nationwide population-based cohort study. BMJ open, 10(6):e034829. 
  • Blotière PO, et al. 2019. Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs. Neurology, 93(2):e167-80. 
  • Bjork MH, et al. 2022. Association of prenatal exposure to antiseizure medication with risk of autism and intellectual disability. JAMA Neurol, 79(7):672.  
  • Bozhinov PSB, et al. 2004. Normalisation of impaired reproduction functions after switching to topiramate monotherapy. Epilepsia, 45(Suppl 3):152. 
  • Bromley RL, et al. 2016. Cognition in school-age children exposed to levetiracetam, topiramate, or sodium valproate. Neurology, 87(18):1943-53. 
  • Christensen J, et al. 2024. Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries. Lancet, Reg Health Eur, 38:100849. 
  • Committee on Drugs. 2001. The transfer of drugs and other chemicals into human milk. Pediatrics, 108(3):776-789. 
  • Doose DR, et al. 2003. Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. Epilepsia, 44(4):540-549. 
  • Fröscher W, et al. 2006. Topiramate use during breast feeding. Aktuel Neurol, 33:215-217. 
  • Gentile S. 2009. Topiramate in pregnancy and breastfeeding. Clin Drug Investig, 29:139-141. 
  • Hao N, et al. 2025. Seizure control and pregnancy outcomes in Chinese women with epilepsy: A prospective multicenter cohort study. Epilepsia, 66(5):1573-1584. 
  • Heinonen OP, Slone D, Shapiro S. 1977. Birth defects and drugs in pregnancy. Littleton, MA: John Wright-PSG, pp 389, 391-392, 394, 443, 478, 497. 
  • Hernandez-Diaz S, et al., for the North American AED Pregnancy Registry. 2012. Comparative safety of antiepileptic drugs during pregnancy. Neurology, 78:1692-1699. 
  • Hernandez-Diaz S, et al. 2014. Association between topiramate and zonisamide use during pregnancy and low birth weight. Ob Gyn, 123(1):21-28. 
  • Hernandez-Diaz S, et al. 2017. Fetal growth and premature delivery in pregnant women on antiepileptic drugs. Ann Neurol, 82(3):457-465. 
  • Hernandez-Diaz S, et al. 2018.  Topiramate use early in pregnancy and the risk of oral clefts: a pregnancy cohort study. Neurology, 90(4):e342-351. 
  • Hernandez-Diaz S, et al. 2024. Risk of autism after prenatal topiramate, valproate, or lamotrigine exposure. N Engl J Med, 390:1069-1079. 
  • Hernandez-Diaz S, et al., 2025. Use of Antiseizure Medications Early in Pregnancy and the Risk of Major Malformations in the Newborn. Neurology, 105(3):e213786. 
  • Holtkamp M, et al. 2005. Erectile dysfunction with topiramate. Epilepsia, 46(1):166-167. 
  • Johannessen SI, et al. 2005. Levetiracetam concentrations in serum and in breast milk at birth and during lactation. Epilepsia, 46:775-777. 
  • Keni RR, et al. 2018. Teratogenicity of antiepileptic dual therapy: Dose-dependent, drug-specific, or both?. Neurology, 90(9): e790-796. 
  • Keni RR, et al. 2020.  Anti-epileptic drug and folic acid usage during pregnancy, seizure and malformation outcomes: Changes over two decades in the Kerala Registry of Epilepsy and Pregnancy. Epilepsy Research, 159:106250. 
  • Laspro M, et al. 2025. Association of Commonly Prescribed Antepartum Medications and Incidence of Orofacial Clefting. The Cleft Palate Craniofacial Journal, 62(7):1164-1174. 
  • Madley-Dowd P, et al. 2024. Antiseizure medication use during pregnancy and children’s neurodevelopmental outcomes. Nature Communications, 15(1). 
  • Öhman I, et al. 2002. Topiramate kinetics during delivery, lactation, and in the neonate: Preliminary observations. Epilepsia, 43:1157-1160. 
  • Öhman I, et al. 2007. Topiramate kinetics during lactation. Epilepsia, 48(Supp 7):156-157. 
  • Ornoy A, et al. 2017. Antidepressants, antipsychotics, and mood stabilizers in pregnancy: what do we know and how should we treat pregnant women with depression. Birth defects research, 109(12):933-956. 
  • Tomson T, et al. 2018.  Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry. The Lancet Neurology, 17(6):530-538. 
  • Vajda FJ, et al. 2016. Antiepileptic drug combinations not involving valproate and the risk of fetal malformations. Epilepsia, 57(7):1048-1052. 
  • Vajda FJ, et al. 2018.  Antiepileptic drug polytherapy in pregnant women with epilepsy. Acta Neurologica Scandinavica, 138(2):115-121. 
  • Vajda FJ, et al.  2019.  Antiepileptic drugs and foetal malformation: analysis of 20 years of data in a pregnancy register. Seizure, 65:6-11. 
  • Vajda FJ, et al.  2020.  Preexisting illness, fetal malformation, and seizure control rates in pregnant women with epilepsy. Epilepsy & Behavior; 9:106481. 
  • Veroniki AA, et al. 2017. Comparative safety of anti-epileptic drugs during pregnancy: a systematic review and network meta-analysis of congenital malformations and prenatal outcomes. BMC medicine. 15(1):95. 
  • Westergren T, et al. 2014. Probable topiramate-induced diarrhea in a 2-month-old breast-fed child – A case report. Epilepsy Behav Case Rep, 2:22-23. Weston J, et al. 2016. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane
  • Database Syst Rev, 11: Cd010224. 
  • Wu M, et al. 2016. Spermatorrhea and loss of libido induced by topiramate: First case report and review of literature. Clin Neuropharm, 39:325-326. 
  • Zeng Y, et al. 2025. Safety concerns of maternal antiseizure medications exposure on perinatal and offspring outcomes: a disproportionality analysis based on FDA adverse event reporting system. Journal of Neurology, 272:429. 

MotherToBaby cuenta con el apoyo de la Administración de Recursos y Servicios de Salud (HRSA) del Departamento de Salud y Servicios Humanos de los Estados Unidos (HHS) como parte de una adjudicación por un total de $6,000,000 con cero porcentaje financiado con fuentes no gubernamentales. Los contenidos son los del autor/es y no representan necesariamente los puntos de vista oficiales de, ni un respaldo, por HRSA, HHS o el Gobierno de los Estados Unidos.