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. 


Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References:

  • Gallagher M. 2018. Exposure to Dihyroxyacetone in Sunless Tanning Products. Understanding the Risks. J Dermatol Nurses Assoc. 10(1)11-17. 
  • Meadows M. 2003. Don’t be in the dark about tanning. FDA Consumer Magazine, 37:6.  
  • Turner J et al. 2023. In search of the perfect tan: Chemical activity, biological effects, business considerations, and consumer implications of dihydroxyacetone sunless tanning products. J Cosmet Dermatol. 22(1)79-88. 
  • United States Food and Drug Administration (FDA). 2022. Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Available at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.  
  • United States Food and Drug Administration (FDA). 2024. Sunless tanners and bronzers. Available at https://www.fda.gov/cosmetics/cosmetic-products/sunless-tanners-bronzers  
  • Yourick JJ, et al. 2004. Fate of chemicals in skin after dermal application: Does the in vitro skin reservoir affect the estimate of systemic absorption? Toxicol Appl Pharmacol, 195:309-320.


Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References

  • Ankarfeldt MZ, et al. 2021. Exposure to duloxetine during pregnancy and risk of congenital malformations and stillbirth: A nationwide cohort study in Denmark and Sweden. PLOS Medicine, 18(11):e1003851. 
  • Ankarfeldt MZ, et al. 2023. Duloxetine exposure during pregnancy and the risk of offspring being born small for gestational age or prematurely: A nationwide Danish and Sweden safety study. Drugs Real World Outcomes, 10(1):69-81. 
  • Bellantuono C, et al. 2015. The safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review.  Hum Psychopharmacol,  30(3):143-51. 
  • Gentile S, et al. 2019. Managing fibromyalgia syndrome in pregnancy no bridges between USA and EU. Archives of Women’s Mental Health, 22(6):711-721.   
  • Hoog SL, et al. 2013. Duloxetine and pregnancy outcomes: safety surveillance findings. International Journal of Medical Sciences. 10(4):413-419. 
  • Huybrechts KF, et al. 2020 Maternal and fetal outcomes following exposure to duloxetine in pregnancy: cohort study. BMJ 368:m237. 
  • Kallen B, et al. 2013. The use of central nervous system active drugs during pregnancy. Pharmaceuticals. 6(10):1221-1286. 
  • Kjaersgaard MI, et al. 2013. Prenatal antidepressant exposure and risk of spontaneous abortion – a population-based study. PLoS One, 8(8):e72095. 
  • Lassen D, et al. 2016. First-Trimester Pregnancy Exposure to Venlafaxine or Duloxetine and Risk of Major Congenital Malformations: A Systematic Review. Basic & clinical pharmacology & toxicology. 118(1):32-6. doi:10.1111/bcpt.12497. 
  • Liu D, et al. 2025. Uncovering safety signals of duloxetine: Real-world evidence from the FAERS database. J Affect Disord. 388:119517. doi:10.1016/j.jad.2025.119517 
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  • Punjani N, et al. 2021. Impact of duloxetine on male fertility: A randomized controlled clinical trial. Andrologia, 53(10):e14207. 
  • Richendrfer H, et al. 2018. Cluster analysis profiling of behaviors in zebrafish larvae treated with antidepressants and pesticides. Neurotoxicology Teratology, 69:54-62.  


Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References:

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  • Borgatta L, et al. 1997. Clinical significance of methohexital, meperidine, and diazepam in breast milk. J Clin Pharmacol. 37:186-92. 
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  • Calderon-Margalit R, et al. 2009. Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy. Am J Obstet Gynecol. 201(6):579.e1-579.e1-8. 
  • Chen VC, et al. 2022. Association of prenatal exposure to benzodiazepines with development of autism spectrum and attention-deficit/hyperactivity disorders. JAMA Netw Open. 5(11): e2243282. 
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  • Czeizel A, et al. 1999. The effect of diazepam and promethazine treatment during pregnancy on the somatic development of human offspring. Neurotoxicol Teratol. 21(2):157-167. 
  • Diazepam drug label. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167ee280-be68-4a28-a7d8-de41df14bc48&audience=consumer  
  • Engeland A, et al. 2013. Effects of preconceptional paternal drug exposure on birth outcomes: cohort study of 340 000 pregnancies using Norwegian population-based databases. Br J Clin Pharmacol. 75(4):1134-1141. 
  • Freeman MP, et al. 2018. Obstetrical and neonatal outcomes after benzodiazepine exposure during pregnancy: Results from a prospective registry of women with psychiatric disorders. Gen Hosp Psychiatry 53:73-79. 
  • Gilder ME, et al. 2021. Outcomes for 298 breastfed neonates whose mothers received ketamine and diazepam for postpartum tubal ligation in a resource-limited setting. BMC Pregnancy Childbirth. 21(1):121.  
  • Grigoriadis S, et al. 2020. Pregnancy and delivery outcomes following benzodiazepine exposure: a systematic review and meta-analysis. Can J Psychiatry. 65(12): 821-834. 
  • Iqbal MM, et al. 2002. Diazepam use during pregnancy: a review of the literature. Del Med J. 74(3):127-135. 
  • Jensen AG, et al, 2022. Prenatal exposure to benzodiazepines and the development of the offspring: a systematic review. Neurotoxicol Teratol. 91:107078. 
  • Jørgensen NP, et al. 1988. Pharmacokinetics and distribution of diazepam and oxazepam in early pregnancy. Acta Obstet Gynecol Scand. 67(6):493-497.  
  • Kjaer D, et al. 2007. Use of phenytoin, phenobarbital, or diazepam during pregnancy and risk of congenital abnormalities: a case-time-control study. Pharmacoepidemiol Drug Saf. 16(2):181-188. 
  • Laegreid L, et al. 1990. Congenital malformations and maternal consumption of benzodiazepines: a case-control study. Dev Med Child Neurol. 32(5):432-441. 
  • Laegreid L, et al. 1992. Neurodevelopment in late infancy after prenatal exposure to benzodiazepines–a prospective study. Neuropediatrics. 23(2):60-67. 
  • L, et al. 1992. The effect of benzodiazepines on the fetus and the newborn. Neuropediatrics. 23(1):18-23. 
  • Noh Y, et al. 2022. First-trimester exposure to benzodiazepines and risk of congenital malformations in offspring: A population-based cohort study in South Korea. PLoS Med. 19(3): e1003945. 
  • Ornoy A, et al. 1998. Is benzodiazepine use during pregnancy really teratogenic? Reprod Toxicol. 12(5):511-515. 
  • Rementeria J, Bhatt K. 1977. Withdrawal symptoms in neonates from intrauterine exposure to diazepam. J Pediatr. 90(1):123-126. 
  • Rosenberg L, et al. 1983. Lack of relation of oral clefts to diazepam use during pregnancy. N Engl J Med. 309(21):1282–1285. 
  • Safra M, Oakley GP. 1975. Association between cleft lip with or without cleft palate and prenatal exposure to diazepam. Lancet. 2(7933):478–480. 
  • Salisbury AL, et al. 2016. The Roles of Maternal Depression, Serotonin Reuptake Inhibitor Treatment, and Concomitant Benzodiazepine Use on Infant Neurobehavioral Functioning Over the First Postnatal Month. Am J Psychiatry. 173(2):147-157. 
  • Saxen I, Saxen L. 1975. Association between maternal intake of diazepam and oral clefts. Lancet. 2(7933):498. 
  • Shiono PH, Mills JL. 1984. Oral clefts and diazepam use during pregnancy. N Engl J Med. 311(14):919–920. 
  • Sundbakk LM, et al. 2022. Association of prenatal exposure to benzodiazepines and Z-hypnotics with risk of attention-deficit/hyperactivity disorder in childhood. JAMA Netw Open. 5(12): e2246889. 
  • Szpunar MJ, et al. 2022. Risk of major malformations in infants after first‐trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. Depress Anxiety. 39(12):751-759. 
  • Uguz F. 2021. A new safety scoring system for the use of psychotropic drugs during lactation. Am J Ther 2021;28:e118–e126. 
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  • Wall-Wieler E, et al. 2020. Benzodiazepine use before conception and risk of ectopic pregnancy. Hum Reprod. 35(7):1685-1692. 
  • Wang X, et al. 2022. Prenatal exposure to benzodiazepines and Z-drugs in humans and risk of adverse neurodevelopmental outcomes in offspring: A systematic review. Neurosci Biobehav Rev. 137:10464. 
  • Wesson DR, et al. 1985. Diazepam and desmethyldiazepam in breast milk. J Psychoactive Drugs. 17(1):55-56. 
  • Wikner BN, et al. 2007. Use of benzodiazepines and benzodiazepine receptor agonists during pregnancy: neonatal outcome and congenital malformations. Pharmacoepidemiol Drug Saf. 16(11):1203-1210. 
  • Yonkers KA, et al. 2017. Association of panic disorder, generalized anxiety disorder, and benzodiazepine treatment during pregnancy with risk of adverse birth outcomes. JAMA Psychiatry. 74(11):1145-1152. 


Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References:

  • Bandoli G, et al. 2010 Potentially modifiable risk factors for adverse pregnancy outcomes in women with psoriasis. Br J Dermatol; 163(2):334-339. 
  • Ben-David G, et al. 2008. Pregnancy outcome in women with psoriasis. J Reprod Med; 53(3):183-187.  
  • Berman M, et al. 2018. The effect of pregnancy on disease activity in patients with psoriatic arthritis. J Rheumatol; 45(12):1651-1655. 
  • Bobotsis R, et al. 2016. Psoriasis and adverse pregnancy outcomes: a systematic review of observational studies. Br J Dermatol; 175(3):464-472.  
  • Bröms G, et al. 2018. Effect of maternal psoriasis on pregnancy and birth Outcomes: A population-based cohort study from Denmark and Sweden. Acta Derm Venereol; 98(8):728-734. 
  • Butler DC, et al. 2014. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol; 70(3):417.e1-10; quiz 427.  
  • Caldarola G, et al. 2017. Untreated psoriasis impairs male fertility: A case-control study. Dermatology; 233(2-3):170-174. 
  • Carman WJ, et al. 2017. Pregnancy and infant outcomes including major congenital malformations among women with chronic inflammatory arthritis or psoriasis, with and without etanercept use. Pharmacoepidemiol Drug Saf; 26(9):1109-1118. 
  • Cohen-Barak E, et al. 2011. Pregnancy outcomes in women with moderate-to-severe psoriasis. J Eur Acad Dermatol Venereol; 25(9):1041-1047.  
  • Eudy AM, et al. 2020. Pregnancy outcomes, fertility, and family planning in with psoriatic arthritis. Obstet Med; 13(2)70-75. 
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  • Harder E, et al. 2014. No increased risk of fetal death or prolonged time to pregnancy in women with psoriasis. Invest Dermatol; 34(6):1747-1749. 
  • Huerta C, et al. 2007. Incidence and Risk Factors for Psoriasis in the General Population. Arch Dermatol; 143(12):1559-1565. 
  • Johansen CB, et al. 2022. Psoriasis and adverse pregnancy outcomes: A nationwide case-control study in 491,274 women in Denmark. JAAD; Int  7: 146–155. 
  • Kerola AM, et al. 2024. Patterns of reproductive health in inflammatory rheumatic diseases and other immune-mediated diseases: a nationwide registry study. Rheumatology (Oxford). keae122. PMID: 38503536. 
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  • Meserve J, et al. 2021. Paternal Exposure to Immunosuppressive and/or Biologic Agents and Birth Outcomes in Patients with Immune-Mediated Inflammatory Diseases. Gastroenterology; 161(1):107-115. 
  • Lima XT, et al. 2012. The impact of psoriasis on pregnancy outcomes. J Invest Dermatol; 132(1):85-91.  
  • McMullan P, et al. 2024. Safety of dermatologic medications in pregnancy and lactation: An Update – Part I: Pregnancy. J Am Acad Dermatol; S0190-9622(24)00109-9.  
  • Murase JE, et al. 2005. Hormonal effect on psoriasis in pregnancy & post-partum. Arch Dermatol; 141(5):601-606. 
  • Murase JE, et al. 2014. Safety of dermatologic medications in pregnancy and lactation: Part I. Pregnancy. J Am Acad Dermatol; 70(3):401.e1-14. 
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  • Smith C, et al. 2020. Birth outcomes and disease activity during pregnancy in a prospective cohort of women with psoriatic arthritis and ankylosing spondylitis. Amer Col Rheum; 72(7):1029-1037 
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  • Ursin K, et al. 2018. Disease activity of psoriatic arthritis during and after pregnancy: A prospective multicenter study. Arthritis Care Res (Hoboken); 71(8):1092-1100. 
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