Since a few published cases reported some forms of birth defect in infant as a result of the mother who consumed high doses of fluconazole (400-800 mg/day) (Diflucan from Pfizer) during pregnancy (both in the first trimester or all), the U.S. Food and Drug Administration (FDA) warned the use of fluconazole in high doses and repeated to pregnant women.
The FDA notes that some forms of birth defect resulting from high dose and repeated use of fluconazole during pregnancy include brachycephaly, abnormalies facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease.
In addition, according to the FDA, those effects seen similar in animal studies.
However, the FDA also stated that the risks is not for single and low dose of fluconazole (150 mg) used to treat vaginal candidiasis (yeast infection).
The FDA therefore advises healthcare professionals to inform these risks if used during pregnancy or become pregnant.
The FDA says, “If a patients uses fluconazole during pregnancy, the patient should be informed on the potential risk to the fetus.”