The U.S. Food and Drug Administration (FDA) lists Felbatol in Pregnancy Category C. This indicates that caution is advised. There have been no studies in women. Studies in animals have not shown malformations but have shown harm during lactation.

The risk of birth defects is higher for women who take more than one AED and for women with a family history of birth defects.

Advise women who are capable of becoming pregnant to take at least 400 mcg (0.4 mg) of folic acid (folate) daily to help prevent neural tube defects. Women at high risk, such as those with a history of a neural tube defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant. The effectiveness of prophylactic folic acid use in preventing defects related to Felbatol has not been proven, however, so diagnostic ultrasonography at the 18th to 20th week is recommended, especially if pregnancy termination is an option.

About 20% to 35% of women have seizures more often during pregnancy because of changes in hormones or changes in how their AED is handled by the body. It is unclear if Felbatol is affected in this way, so it is advisable to check the blood levels of Felbatol regularly during pregnancy so that the dosage can be adjusted as needed.

The effect of Felbatol in breast milk on healthy, full-term newborns is unknown.