Animal studies have revealed evidence of fetotoxicity and embryotoxicity when given orally at 10 to 80 times the human dermal dose. The vaginal formulations have been used in clinical trials for the treatment of vaginal candidiasis, generally during the second and third trimester, without evidence of fetal harm. There are no controlled data with the topical formulations in human pregnancy.

The vaginal cream has been used for the treatment of vaginal candidiasis in pregnant patients. In a study of 117 pregnant women, duration of pregnancy ranging from 10 to 42 weeks, patients were treated with 150 mg once a day for 3 days. Three stillbirths were recorded. No congenital abnormalities were recorded among any of the infants.

In another study, 112 pregnant women were treated with 150 mg vaginal suppositories. No malformations were observed in 99 infants for whom information following delivery was available.

Systemic absorption is low when this drug is applied topically to intact human skin.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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.

Topical Cream: This drug should be used during the first trimester of pregnancy only if considered essential to patient welfare and should be used during the second and third trimesters of pregnancy only if clearly needed; according to some experts, use is not recommended.
Topical Foam: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
Vaginal Formulations: This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: A
US FDA pregnancy category:
-Topical Cream: Not assigned.
-Topical Foam: C

Risk summary: Malformative risk with use of this drug in pregnant women is unlikely.

See references

Use is considered acceptable; caution is recommended.
-According to some experts: A decision should be made to discontinue breastfeeding or discontinue the topical cream, taking into account the importance of the drug to the mother and the benefit of breastfeeding to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (after oral administration)

Comments:
-The effects in the nursing infant are unknown; low risk is expected (less than 1% absorbed after topical use).
-Application to the nipple area should be avoided.

See references