Can I take terbinafine while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral doses up to 12 and 23 times the maximum recommended human dose (MRHD) of 250 mg/day, respectively (see data). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): TERBINAFINE HYDROCHLORIDE (oral), Golden State Medical Supply, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Limited information indicates that oral maternal doses of 500 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor the infant for jaundice or other signs of liver toxicity, especially in younger, exclusively breastfed infants. Some sources recommend avoiding oral terbinafine during nursing.[1]

Topical terbinafine has not been studied during breastfeeding. Because only about 1% is absorbed after topical application, it is considered a low risk to the nursing infant.[1,2] Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream, gel or liquid products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[3]

“Summary of Use during Lactation”, LactMed record “Terbinafine” (LM518), quoted verbatim. Everything LactMed reports about Terbinafine while breastfeeding.

8.2 Lactation Risk Summary After oral administration, terbinafine is present in human milk. However, there are no data on the effects on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for terbinafine tablets and any potential adverse effects on the breastfed child from terbinafine tablets or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation”: TERBINAFINE HYDROCHLORIDE (oral), Golden State Medical Supply, Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.