Animal studies have failed to reveal evidence of embryo-fetal toxicity in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended human dose (MRHD). Maternal toxicity and aborted litters have occurred at doses 10 times or higher than MRHD. 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.

Use is recommended only if clearly needed and the benefit outweighs the risk

US FDA pregnancy category: Not assigned

Risk Summary: Limited data is available to inform a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; in animal models, adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity.

See references

Use is contraindicated

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

Comments:
-Because of the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment and for 5 days after the final dose.

See references