Fungal skin and nail infections are common health issues affecting an estimated 10%-20% of the world's population. The antifungal agent terbinafine shows broad-spectrum activity against a wide range of fungal species and is commonly prescribed as a first-line treatment for dermatomycoses and onychomycoses. However, owing to insufficient data regarding embryotoxicity and adverse pregnancy outcomes, treatment with terbinafine is currently not recommended in pregnancy and breastfeeding. This systematic review aimed to evaluate the effects of gestational terbinafine exposure on congenital malformations, spontaneous abortions, and adverse pregnancy outcomes. PubMed/MEDLINE, EMBASE, and clinicaltrials.org were searched to retrieve relevant reports up to March 2022. Two investigators independently screened the articles, extracted the data, and performed a quality assessment using the Newcastle-Ottawa Scale. Two cohort and two case-control studies were eligible for inclusion. Overall, the study showed the absence of an increased risk of congenital malformations, spontaneous abortion, preterm birth, small for gestational age, low birth weight, or stillbirth, following systemic or topical terbinafine exposure during pregnancy. In conclusion, the use of systemic and topical terbinafine during pregnancy can be regarded as safe for mothers and unborn children. The current recommendation concerning gestational terbinafine administration should be reconsidered.
Keywords: Terbinafine; congenital malformation; fungal infection; pregnancy outcome; spontaneous abortion; stillbirth.