We evaluated pregnancy outcomes in 234 women exposed to fluconazole, 492 ex
posed to a topically administered azole preparation, 88 exposed to an oral
azole preparation other than fluconazole, and 1629 not exposed to any of th
ese agents during the first trimester of pregnancy. Relative risks of havin
g a baby with a congenital disorder for women exposed to fluconazole, oral
azoles, and topical azoles in the first trimester of pregnancy compared wit
h those who were unexposed were 1.1 (95% CI 0.4-3.3), 2.1 (95% CI 0.7-6.8),
and 0.6 (95% CI 0.2-1.6), respectively These results provide reassurance t
hat fluconazole exposure in the first trimester of pregnancy does not mater
ially increase the risk of congenital disorders in infants.