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MotherToBaby

Medications and More during pregnancy and breastfeeding

Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References:

  • Amaral De Lara IC, et al. 2025. Association of prenatal exposure to antiseizure medication with risk of autism: a systematic review and meta-analysis. Seizure; 130:41-47. 
  • Adrade C. 2024. Epilepsy, antiepileptic drugs, and adverse pregnancy outcomes, 2: Major congenital malformations with antiepileptic drug monotherapy. J Clin Psychiatry; 85(3):24f15432. 
  • Artama M, et al. 2006. Antiepileptic drug use and birth rate in patients with epilepsy-a population-based cohort study in Finland. Hum Reprod; 21:2290-2295. 
  • Battino D, et al. 2024. Risk of major congenital malformations and exposure to antiseizure medication monotherapy. JAMA Neurol; 82(5):481-489. 
  • Bech LF, et al. 2018. In utero exposure to antiepileptic drugs is associated with learning disabilities among offspring. J Neurol Neurosurg Psychiatry; 89:1324–1331. 
  • Birnbaum AK, et al. 2020. Antiepileptic drug exposure in infants of breastfeeding mothers with epilepsy. JAMA Neurol; 77(4):441-450. 
  • Bjork M-H, et al. 2022. Association of prenatal exposure to antiseizure medication with risk of autism and intellectual disability. JAMA Neurology; 79(7):672-681. 
  • Blotière PO, et al. 2019. Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs. Neurology; 93(2):e167-e80. 
  • 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.  
  • Bruno MK, Harden CL. 2002. Epilepsy in pregnant women. Curr Treat Options Neurol; 4(1):31-40.  
  • Bülau P, et al. 1988. Pharmacokinetics of oxcarbazepine and 10-hydroxy-carbazepine in the newborn child of an oxcarbazepine-treated mother. Eur J Clin Pharmacol; 34:311–313.  
  • Chen CY, et al. 2017. In utero oxcarbazepine exposure and neonatal abstinence syndrome: Case report and brief review of the literature. Pharmacotherapy; 37:e71–e5.  
  • Christensen J, et al. 2015. Apgar-score in children prenatally exposed to antiepileptic drugs: a population-based cohort study. BMJ Open; 5(9):e007425. 
  • Cohen JM, et al. 2019. Anticonvulsant mood stabilizer and lithium use and risk of adverse pregnancy outcomes. J Clin Psychiatry; 80(4). 
  • Cohen JM, et al. 2023. Comparative safety of antiseizure medication monotherapy for major malformations. Ann Neurol; 93(3):551-562.  
  • Daugaard CA, et al. 2020. Association of prenatal exposure to valproate and other antiepileptic drugs with intellectual disability and delayed childhood milestones. JAMA Netw Open; 3(11):e2025570.  
  • Dreier JW et al. 2023. Prenatal exposure to antiseizure medication and incidence of childhood- and adolescence-onset psychiatric disorders. JAMA Neurology; 80(6):568-577. 
  • Eisenschenk S. 2006. Treatment with oxcarbazepine during pregnancy. Neurologist; 12(5):249-254.  
  • Friis ML, et al. 1993. Therapeutic experiences with 947 epileptic out-patients in oxcarbazepine treatment. Acta Neurol Scand; 87(3):224-227.  
  • Gentile S. 2003. Oxcarbazepine in pregnancy and lactation. Clin Drug Investig; 23:687.  
  • Guo Y, et al. 2021. A comparative study of the effects of valproate and oxcarbazepine on sexual function, sperm quality, and sex hormones in males with epilepsy. Biomed Res Int; 2021:6624101. 
  • Hvas CL, et al. 2000. Epilepsy and pregnancy: effect of antiepileptic drugs and lifestyle on birthweight. Br J Obstet Gynaecol; 107:896-902. 
  • 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.  
  • Honybun E, et al. Neurodevelopmental and functional outcomes following in utero exposure to antiseizure medication: a systematic review. Neurology; 102(8)e209175.  
  • Isojarvi JI, et al. 2004. Effect of epilepsy and antiepileptic drugs on male reproductive health. Neurology; 62:247-253. 
  • Jacobsen PE, et al. 2014. Prenatal exposure to antiepileptic drugs and dental agenesis. PLoS One; 9(1):e84420. 
  • Johnson K, et al. 2021. Retrospective Analysis of Oxcarbazepine in Pregnant Women With Substance Use Disorders: Focus on Safety. Journal of Pharmacy Practice; 34(1):28-34. 
  • Kaaja E, et al. 2003. Major malformations in offspring of women with epilepsy. Neurology; 60:575-579.  
  • Kim HK, et al. 2026. Prenatal Exposure to Antiseizure Medications and the Risk of Congenital Anomalies: A Nationwide Population-Based Study in South Korea. Neurology; 106(1):e214350.  
  • Lloyd P, et al. 1994. Clinical Pharmacology and Pharmacokinetics of Oxcarbazepine. Epilepsia; 35(s3). 
  • Luef G, et al. 2009. Oxcarbazepine treatment in male epilepsy patients improves pre-existing sexual dysfunction. Neurologica; 119(2):94-99.  
  • Lutz UC, et al. 2007. Oxcarbazepine treatment during breast-feeding: a case report. J Clin Psychopharmacol; 27:730–732.  
  • Meischenguiser R, et al. 2003. Major malformations in offspring of women with epilepsy. [Letter] Neurology; 61:1631. 
  • Meischenguiser R, et. al. 2004. Oxcarbazepine in pregnancy: clinical experience in Argentina. Epilepsy Behav; 5:163-167. 
  • Miller M, et al. 2003. Major malformations in offspring of women with epilepsy. [Letter] Neurology; 61:1631. 
  • Mølgaard-Nielsen D, Hviid A. 2011. Newer-generation antiepileptic drugs and the risk of major birth defects. JAMA; 305(19):1996-2002. 
  • Montouris G. 2005. Safety of the newer antiepileptic drug oxcarbazepine during pregnancy. Curr Med Res Opin; 21:693-701. 
  • Novartis. 2020. Trileptal® Prescribing Information. Available at URL: https://www.novartis.us/sites/www.novartis.us/files/trileptal.pdf.  
  • Ohman I, et al. 2009. Pharmacokinetics of oxcarbazine in neonatal period and during lactation. Epilepsia; 50(Suppl. 4):238. Abstract. 
  • Rolnitsky A, et al. 2013. In utero oxcarbazepine and a withdrawal syndrome, anomalies, and hyponatremia. Pediatr Neurol; 2013;48(6):466-468.  
  • Supernus Pharmaceuticals. 2018. Otexllar XR® Prescribing Information. Available at URL: https://www.oxtellarxrhcp.com/assets/OxtellarXRPrescribingInformation.pdf. 
  • Straub L, et al. 2026. Prenatal antiseizure drug exposure and risk of neurodevelopmental disorders in children: population based cohort study. BMJ; 392:e085725.  
  • The Centers for Disease Control and Prevention (CDC). 2025. Folic Acid: Sources and Recommended Intake. Available at https://www.cdc.gov/folic-acid/about/intake-and-sources.html [Accessed 03/2026].  
  • Tomson T, et al. 2015. Antiepileptic drugs and intrauterine death: A prospective observational study from EURAP. Neurology; 85: 580-588. 
  • Tomson T, et al. 2018. Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry. Lancet Neurol; 17(6):530-538.  
  • Trivedi M, et al. 2018. Spontaneous fetal loss in women with epilepsy: prospective data from pregnancy registry in India. Epilepsy Research; 146:50-53. 
  • Vajda F, et al. 2018. Anti-epieptic drug exposure and risk of foetal death in utero. Acta Neurol Scand; 137(1):20-23. 
  • Veiby G, et al. 2014. Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J Neurol; 261:579-588. 
  • Videman M, et al. 2016. Evidence for spared attention to faces in 7-month-old infants after prenatal exposure to antiepileptic drugs. Epilepsy Behav; 64(Pt A):62-68. 
  • Weston J, et al. 2016. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev; 11(11):CD010224. 
  • Wu D, et al. 2018. The effects of oxcarbazepine, levetiracetam, and lamotrigine on semen quality, sexual function, and sex hormones in male adults with epilepsy. Epilepsia; 59(7):1344-1350.  
  • Yin X, et al. 2022.Pharmacokinetic changes for newer antiepileptic drugs and seizure control during pregnancy. CNS Neurosci Ther; 28(5):658-666. 

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