When this drug was given to animals in doses 80 to nearly 1000 times the recommended daily dose for humans, it caused developmental toxicity. The incidence of embryolethality increased at the highest dose. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

US FDA pregnancy category: C

See references

There are no published experiences with use during breastfeeding. If this drug is used by the mother, it is not considered necessary to discontinue breastfeeding, however alternate drugs may be preferred, especially while nursing a newborn or preterm infant. Levels of this drug in rat milk were up to 7 times higher than in rat plasma.

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Infant exposure may be minimized by avoiding breastfeeding for 24 hours.

See references