Animal studies have failed to reveal evidence of teratogenicity. In pregnant rats and rabbits administered oral doses during organogenesis at 100, 300, and 1000 mg/kg/day (up to 4 times the clinical dose based on AUC comparisons) and up to 100 mg/kg/day (about 0.1 times the clinical dose based on AUC comparisons), respectively, maternal toxicity (including reduced body weight gain at 300 mg/kg/day and higher in rats; reduced food intake and markedly reduced body weight gain at 100 mg/kg/day in rabbits) was seen; no evidence of adverse developmental outcomes was observed in rats or rabbits. There are no controlled data in human pregnancy.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Breastfeeding is not recommended during use of this drug and for 96 hours after dose administration.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No data available on the clinical use of this drug during breastfeeding and no studies have evaluated side effects of this drug on the nursing infant; such effects are presumed similar to those of metronidazole (a closely related drug), such as increased risk of oral and rectal Candida infections.
-Other nitroimidazole derivatives are excreted into human milk.
-The effects in the nursing infant are unknown; potential for serious side effects (including tumorigenicity)
-Nursing mothers may pump and discard their milk during and for 96 hours (based on half-life) after therapy and feed their infants stored human milk or formula.

As with metronidazole, there has been concern regarding exposure of healthy infants to this drug via breast milk due to possible mutagenicity and carcinogenicity. The recommendation to avoid breastfeeding for 96 hours after a single dose of this drug is based on its elimination half-life of about 17 hours. Other agents are available for bacterial vaginosis, and can be administered vaginally, which should result in lower amounts in breast milk.

See references