Use only if clearly needed

US FDA pregnancy category: B

The safety in pregnant women has not been established.

Fetotoxicity was indicated by a slight but significant reduction in fetal weight in rats given 450 mg/kg, and a slight reduction in fetal weight, delayed ossification of the fetal skeleton, and an increase in the percentage of nonviable fetuses in rabbits given 200 mg/kg (12 and 10 times the maximum recommended human dose based on body surface area, respectively). These studies revealed no evidence of fetal malformations.

There are no controlled data in human pregnancy.

FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

This drug has been shown to be poorly excreted into human milk with 0.02% of a 100 mg dose or 0.2% of the weight-adjusted maternal dose being excreted. Despite these low levels the manufacturer recommends this drug not be administered to nursing women. There is no published information available to describe effects in breastfed infants.

Use is not recommended

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown

See references