This sheet is about exposure to oxcarbazepine in pregnancy or while breastfeeding. This information is based on published research studies. It should not take the place of medical care and advice from your healthcare provider.
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 women 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 woman who is pregnant as well as to the pregnancy. Women 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 woman who is pregnant and the pregnancy. Women should discuss their options for treatment, including medications, with their healthcare providers before getting pregnant when possible.
Oxcarbazepine might lower levels of folic acid in people who take this medication. According to The Centers for Disease Control and Prevention (CDC), The National Institutes of Health (NIH), and The US Preventive Services Task Force (USPSTF): Women who could become pregnant or are already pregnant should get enough folic acid, a B vitamin. Talk to your healthcare provider about how much folic acid is right for you. Please see our MotherToBaby fact sheet and baby blog on folic acid/folate at https://mothertobaby.org/fact-sheets/folic-acid/ and https://mothertobaby.org/baby-blog/folic-acid-is-more-really-better/.
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 women 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. We look at research studies to try to understand if an exposure, like oxcarbazepine, might increase the chance of birth defects in a pregnancy.
Animal studies suggest that oxcarbazepine might increase the chance of birth defects. However, reports on almost 3,400 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?
It is not known if oxcarbazepine can increase the chance of other pregnancy-related problems, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth). Animal studies have suggested that oxcarbazepine might increase the chance of lower birth weight. One small study in humans also found low birth weight 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 women 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. Women 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 during my 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 women 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 between ages 6 years to 14 years suggested an increased chance of intellectual disability after prenatal exposure to anticonvulsant medications including oxcarbazepine. Another large study of 845 children exposed to oxcarbazepine reported an increased chance of intellectual disability, but not ADHD, autism, or other behavioral concerns. However, it is unclear what the researchers defined as intellectual disability, which limits the conclusions that can be drawn from the study.
A large study that analyzed results from multiple different studies reported a slightly increased chance of autism in children exposed to oxcarbazepine during pregnancy. However, a similar study reported that there is mixed information on if taking oxcarbazepine in pregnancy can increase the chance of behavior or learning issues for a child.
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.
Because behavior and learning are influenced by many factors, it is hard to know if the medication or other factors, such as environment or family members with behavior or learning issues, are contributing to the reported increases.
Breastfeeding while taking oxcarbazepine:
Oxcarbazepine passes into breast milk. Eleven case reports found very low levels of the medication in the blood of breastfed infants. Seventeen case reports describe healthy children with no side effects after being exposed to oxcarbazepine through breast milk. If you suspect the baby has any symptoms (being very sleepy, unable to wake up for feeds, or poor weight gain), contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man takes oxcarbazepine, could it affect fertility or increase the chance of birth defects?
It is not known if taking oxcarbazepine can affect male fertility (ability to make healthy sperm). Men who have epilepsy might have reduced sperm quality and sexual function. This makes it hard to know if effects on male sexual function and fertility are related to the medication, to the underlying condition, or other factors. In general, exposures that men have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet on Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
Please click here for references.
