Miconazole Pregnancy and Breastfeeding Warnings
Brand names: Oravig
Medically reviewed by Drugs.com. Last updated on May 29, 2025.
Miconazole Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-According to some authorities: Benefit should outweigh risk.
-According to some authorities: Use should be avoided if possible.
AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned
Risk summary: Based on animal data, this drug may cause fetal harm. No data are available on the use of this drug in pregnant women to inform a drug-related risk.
Comments: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, or teratogenicity during IV studies; IV doses of 40 and 20 mg/kg/day in rats and rabbits, respectively, are about 8 times higher than the dose a patient would receive if a buccal tablet was swallowed (based on body surface are comparisons). High oral doses (80 mg/kg/day or higher) resulted in embryofetal toxicity (including fetal resorptions) in rats and rabbits and prolonged gestation and dystocia in rats. This drug was shown to cross the placenta in rats and rabbits. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Miconazole Breastfeeding Warnings
Caution is recommended.
-According to some authorities: Use is not recommended unless it is considered essential or alternative feeding arrangements can be made for the nursing infant.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
See also
References for pregnancy information
- Wallenburg HCS, Wladimiroff JW (1976) "Recurrence of vulvovaginal candidosis during pregnancy." Obstet Gynecol, 48, p. 491-4
- McNellis D, Facog, McLeod M, Lawson J, Pasquale SA (1977) "Treatment of vulvovaginal candidiasis in pregnancy." Obstet Gynecol, 50, p. 674-8
- Weisberg M (1986) "Treatment of vaginal candidiasis in pregnant women." Clin Ther, 8, p. 563-7
- Rosa FW, Baum C, Shaw M (1987) "Pregnancy outcomes after first-trimester vaginitis drug therapy." Obstet Gynecol, 69, p. 751-5
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2010) "Product Information. ORAVIG (miconazole)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc.
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2010) "Product Information. ORAVIG (miconazole)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.