Animal studies have shown increases in congenital abnormalities (neural tube defect, cleft palate, exencephaly). There are no controlled data in human pregnancy. Additionally, studies have shown low potential to cross the maternal/fetal placental barrier.

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 justifies the potential risk to the fetus.

US FDA pregnancy category: C

See references

This drug should be used only if the potential benefit outweighs the potential risk to the infant.

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

Comments: The effects in the nursing infant are unknown.

See references