Animal studies have failed to reveal evidence of adverse fetal effects, including pre- and postnatal development, given during organogenesis at doses up to 200 mg/kg/day. Exposure to this drug in a small cohort of pregnant women did not show adverse fetal outcomes, associated risk for major birth defects, or miscarriage. 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: Malformative risk with use of this drug in pregnant women is unlikely.

Comment: This drug is minimally absorbed after oral administration (i.e., less than 0.5 ng/mL).

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-This drug is minimally absorbed after oral administration (i.e., less than 0.5 ng/mL).

See references