In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk. This fact sheet talks about whether exposure to topiramate may increase the risk for birth defects over that background risk. This information should not take the place of medical care and advice from your health care provider.

What is topiramate?

Topiramate (Topamax®, Trokendi XR®, Qudexy XR®) is an antiepileptic medication used to prevent seizures and migraine headaches, and treat bipolar disorder. It is also part of a weight loss drug called Qysymia®. The use of topiramate at the same time as birth control medications may make the birth control product less effective. Please discuss this with your health care provider if you take topiramate and want to take birth control medications.

I am taking topiramate, but I would like to stop taking it before becoming pregnant. How long does topiramate stay in your body?

Each person’s ability to break down medication may be different, and may be influenced by your age and other medications you may be taking. It takes between 4 and 6 ½ days for most of the topiramate to leave your body. It is important that you not stop taking topiramate without first talking to your health care provider. It is important to discuss the risks and benefits to you from stopping the medication, as well as the potential risks from the untreated disease or symptoms during pregnancy. If you are taking topiramate for seizure control, migraine prevention or a mental health condition and are planning a pregnancy, ideally you want a treatment plan well in advance of getting pregnant. Women taking topiramate are advised to take a higher dose of folic acid (a B vitamin) before becoming pregnant to help lower the chance for a birth defect. Talk to your health care provider about all of these issues.

I have been taking topiramate for many years. Can taking topiramate make it harder to become pregnant?

Probably not. The effect of topiramate on a woman’s ability to conceive has not been well studied. However, at this time it does not appear that topiramate can make it more difficult to become pregnant.

I have been taking topiramate and just found out I am pregnant. Should I stop?

You should not stop taking topiramate without first talking to your health care provider. The benefits of taking topiramate must be weighed against the potential risks to the pregnancy. Having a seizure or untreated depression in pregnancy may be harmful to both the pregnant woman and the baby. If your symptoms are well controlled on topiramate, and there are no other options that are better-studied, your health care provider may advise against changing or stopping your medication.

Can taking topiramate during my pregnancy cause birth defects?

Possibly. Although most children born to women who take topiramate during pregnancy do not have a birth defect, there is a small increased chance for birth defects when taking topiramate in the first trimester. The chance for a birth defect may be influenced by the dose of topiramate, the level of topiramate in the blood, whether topiramate is taken alone or in combination with other antiepileptic medications, and possibly other factors. Studies suggest that topiramate use in the first trimester may increase the chance that a baby will be born with a cleft lip and/or a cleft palate (split lip or opening in the roof of the mouth). Also, studies suggest a higher risk for being small for gestational age.

What could happen to my baby if I stopped taking my topiramate and then had a seizure during my pregnancy?

The effect of untreated seizures during pregnancy is not well-known, however, there is concern that untreated seizures could cause falls that could result in physical harm to both mother and developing baby.

Will taking topiramate during pregnancy affect my baby’s behavior and development?

One study has raised concern that prenatal topiramate might have an effect on learning and motor coordination. This study was very small and included only 9 pre-school aged children whose mothers took topiramate during pregnancy. The researchers were not able to be certain if the use of topiramate caused the problems with behavior and development in these children. Much more information is needed before we can understand if topiramate use in pregnancy can cause behavior and developmental problems in exposed children.

Can I use topiramate while I am breastfeeding?

Probably. Topiramate can be found in breast milk; but babies exposed through breastfeeding usually have very low levels of topiramate in their systems. Side effects or harmful effects in the nursing baby are rarely reported. Your health care provider can help you make this decision depending on your dose, what other medications you may be taking, and the health of your baby. In the unlikely event that you notice any changes in the baby, discuss with your pediatrician.

What if the father of the baby takes topiramate?

While some antiepileptic medications may cause abnormal sperm, resulting in infertility in men, there is no specific information on topiramate yet. In general, however, medications that a father takes do not increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet about Paternal Exposures at http://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

Selected References:

  • Carmichael, SL, et.al. 2005. Maternal progestin intake and risk of hypospadias. Archives of Pediatrics & Adolescent Medicine, 159(10):957-962.
  • Committee on Drugs. 2001. The transfer of drugs and other chemicals into human milk. Pediatrics, 108(3), 776-789.
  • Heinonen OP, Slone D, Shapiro S: Birth defects and drugs in pregnancy. Littleton, Mass.: John Wright-PSG, 1977a, pp 389, 391-392, 394, 443, 478, 497.
  • Norman JE, et al. 2009. Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. Lancet 373(9680):2034-2040.
  • Silver RI, et al. 1999. In vitro fertilization is associated with an increased risk of hypospadias. J Urology 161(6):1954-1957.