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Fluconazole (Diflucan®) and Increased Risk of Complications During Pregnancy

May 3, 2016

FDA is currently evaluating data that oral fluconazole (Diflucan®) may increase the risk of miscarriage during pregnancy at doses lower than previously reported. Fluconazole is an azole antifungal agent that is used for the prevention and treatment of certain fungal infections. Current FDA labeling states that fluconazole 150 mg by mouth for a single dose is not associated with an increased risk of complications during pregnancy, while higher doses such as 400 to 800 mg by mouth per day for prolonged periods of time are associated with birth abnormalities. However, in a recent Danish study in which most patients received fluconazole 150 mg by mouth for one to two doses, a possible increased risk of miscarriage was found. FDA issued a MedWatch safety communication and recommends using caution when prescribing oral fluconazole to pregnant patients until FDA has finished analyzing this recent study and all other information. FDA will communicate a final recommendation once the evaluation is complete. CDC recommends use of topical antifungal agents to treat vaginal yeast infections in women who are pregnant. Report adverse events with fluconazole to the FDA MedWatch Program.

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Updated
May 3, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.