Pregnancy outcomes after maternal exposure to fluconazole.
We evaluated pregnancy outcomes in 234 women exposed to fluconazole, 492 exposed to a topically administered azole preparation, 88 exposed to an oral azole preparation other than fluconazole, and 1629 not exposed to any of these agents during the first trimester of pregnancy Relative risks of having a baby with a congenital disorder for women exposed to fluconazole, oral azoles, and topical azoles in the first trimester of pregnancy compared with 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 that fluconazole exposure in the first trimester of pregnancy does not materially increase the risk of congenital disorders in infants.
Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Lexington, Massachusetts, USA.
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D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000935:Antifungal Agents / Q000009:adverse effects*; D005260:Female; D015725:Fluconazole / Q000009:adverse effects*; D006801:Humans; D017880:Limb Deformities, Congenital / Q000139:chemically induced; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011297:Prenatal Exposure Delayed Effects
D000935:Antifungal Agents; D015725:Fluconazole