Healthy pregnancy hub

Oxcarbazepine (Trileptal®, Oxtellar XR®)

Last Update: 08 Apr 2025

Welcome to our fact sheet on Oxcarbazepine (Trileptal®, Oxtellar XR®) during pregnancy and breastfeeding/ chestfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.

The HEALTHY PREGNANCY HUB team is collaborating with MotherToBaby to share information on this topic. The original version is available here (updated on March 2024).

Serene, our chatbot, can also answer your questions about medications during pregnancy.

Please note that this fact sheet is based on United States information and has been adapted for Canada, with a review by our Canadian experts. Minor differences may exist between the two countries. Always consult your healthcare professional for information tailored to your situation.

1. What is oxcarbazepine?

Oxcarbazepine is a medication that has been approved for the treatment of partial seizures. It has also been used to treat migraine, symptoms of dementia, epilepsy, trigeminal neuralgia (nerve pain in the face) and bipolar disorder. Some brand names for oxcarbazepine are Trileptal® and Oxtellar XR®. 

Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take your medication. Having a seizure while pregnant could be harmful to the pregnant individual as well as the pregnancy. Pregnant individuals who have bipolar disorder and stop taking their medication are at increased risk for episodes of depression or mania that may be harmful to both the pregnant individual and the fetus. 

People should discuss their options for treatment, including medications, with their healthcare providers before getting pregnant when possible. People who want to become pregnant should also discuss taking a folic acid supplement with their healthcare providers. 

2. What are the risks according to research?

I take oxcarbazepine. Can it make it harder for me to get pregnant?

Studies have not been done in humans to see if oxcarbazepine can make it harder to get pregnant. Having a seizure disorder, as well as long-term use of seizure medications, might make it harder to get pregnant. 

Does taking oxcarbazepine increase the chance of miscarriage?

Miscarriage is common and can occur in any pregnancy for many different reasons. One study did not find a higher rate of miscarriage among 337 individuals with epilepsy who took oxcarbazepine compared to those with epilepsy who took other medications. 

Does taking oxcarbazepine increase the chance of birth defects?

Birth defects can happen in any pregnancy for different reasons. Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. Animal studies suggest that oxcarbazepine might increase the chance of birth defects. However, reports on almost 2,600 human pregnancies have not suggested a significantly increased chance of birth defects when oxcarbazepine is used. The chance for birth defects might increase when other anticonvulsant medications are used with oxcarbazepine. 

Does taking oxcarbazepine increase the chance of other pregnancy-related problems?

Animal studies have suggested that oxcarbazepine might increase the chance of lower birth weight. One human report also found low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) in 7 out of 8 newborns exposed to oxcarbazepine in pregnancy. However, this report also found that low birth weight was more common among infants born to individuals with epilepsy. Another study of 94 infants did not suggest that exposure to oxcarbazepine at any point in pregnancy increased the chance of low birth weight. 

In rare cases, taking anticonvulsant medications during pregnancy, including oxcarbazepine, can cause bleeding problems in the newborn due to low vitamin K levels. Individuals taking oxcarbazepine in pregnancy should talk with their healthcare providers about taking vitamin K supplements near the end of their pregnancies. They can also talk to their child’s pediatrician before delivery about giving the newborn a vitamin K supplement at birth. 

I need to take oxcarbazepine throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth? 

It is not known if oxcarbazepine can cause withdrawal symptoms in a baby after birth. There are 2 case reports of newborns exposed to oxcarbazepine in pregnancy who had possible withdrawal symptoms after delivery. The symptoms went away after 9 to 12 days and included poor feeding, tremors, irritability, sneezing, and a high-pitched cry. Two case reports are not enough to know if oxcarbazepine was the cause of these symptoms. In contrast, a study of 94 infants exposed to oxcarbazepine at any point in pregnancy did not find an increased risk for withdrawal symptoms compared to infants not exposed to oxcarbazepine. 

Does taking oxcarbazepine in pregnancy affect future behavior or learning for the child?

It is unclear if using oxcarbazepine in pregnancy can increase the chance of behavior or learning issues in children. One study looking at pregnant individuals taking anticonvulsant medications during pregnancy (only 10 took oxcarbazepine) found delayed verbal skills in infants evaluated at age 7 months. Another study that evaluated children at ages 6-14 years suggested an increased chance of intellectual disability after prenatal exposure to anticonvulsant medications including oxcarbazepine. However, other studies have found no differences in neurodevelopment, learning ability, or need for speech therapy in children exposed to oxcarbazepine compared to children exposed to some other anticonvulsant medications or those not exposed to these medications at all. 

3. Breastfeeding/ chestfeeding while taking oxcarbazepine

Oxcarbazepine passes into breast milk/ human milk. Eleven case reports found very low levels of the medication in the blood of nursing infants. Seventeen case reports describe healthy children with no side effects after being exposed to oxcarbazepine through milk. If you suspect the baby has any symptoms (being very sleepy, unable to wake for feeds, or poor weight gain), contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding/ chestfeeding questions. 

4. Fathers and sperm donors

If a male takes oxcarbazepine, could it affect fertility or increase the chance of birth defects?

It is not known if taking oxcarbazepine can affect a male’s fertility (ability to get a partner pregnant). Fathers and sperm donors who have epilepsy might have reduced sperm quality and sexual function. This makes it hard to know if effects on a male’s sexual function and fertility are related to the medication, to the underlying condition, or other factors. In general, exposures that fathers or sperm donors have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet on Paternal Exposures here.

Key points

  • Oxcarbazepine (Trileptal®, Oxtellar XR®) is a medication used to treat seizures (epilepsy), migraines, trigeminal neuralgia, and bipolar disorder.
  • Studies in human are limited regarding the risks of oxcarbazepine on miscarriage, congenital malformation (birth defect), and other problems related to pregnancy.
  • Few studies have been conducted on oxcarbazepine during pregnancy, so it is not known whether it may affect pregnancy outcomes or the child’s future development.
  • Oxcarbazepine passes into breast milk/ human milk. If your baby shows symptoms such as drowsiness or difficulty feeding, contact your healthcare provider.
  • Always consult your healthcare provider before making any changes to your treatment during pregnancy or breastfeeding/ chestfeeding.

References

Please click here for references 

 

*North American Antiepileptic Drug (AED) Pregnancy Registry: There is a pregnancy registry for people who take antiepileptic medications, such as oxcarbazepine. Please see the registry website for more information: https://www.aedpregnancyregistry.org/introduction/ 

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HEALTHY PREGNANCY HUB provides a source of information validated by health professionals; however, this information is provided for informational purposes only and should not replace professional advice. Medical standards and practices evolve as new data becomes available, so it is imperative to consult your doctor or a qualified health professional for any questions or concerns regarding your health without delay or omission. It is the responsibility of your treating physician or any other health professional, based on their independent experience and knowledge of the patient, to determine the best way to evaluate and treat you.

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While consulting symptoms or other medical information on our platform may guide your discussions with your healthcare professional, this information should not be used to make a medical diagnosis or determine treatment. Before making changes to your supplement or medication regimen, please discuss with your medical team or contact 811 (Canada) to ensure the relevance of these changes to your individual situation.

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MotherToBaby
Organization of Teratology Information Specialists (OTIS)
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Émy Roberge
Centre hospitalier universitaire Sainte-Justine
Brigitte Martin
Centre Hospitalier Universitaire Sainte-Justine

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