Animal studies showed no malformations at doses up to 1.8 and 24 times the maximum recommended human dose (MRHD); however, there was an increase in the number of stillbirths and postnatal offspring mortalities at doses of 0.4 and 1.2 x MRHD and a delay in fetal development (decreased fetal weights and delayed ossification) at 24 x MRHD (likely secondary to maternal toxicity). An animal fertility study revealed this drug had no effects on sperm or uterine parameters, but it delayed mating in both sexes which led to a lower number of pregnancies and disrupted estrous cyclicity at a dose of 1.2 x MRHD.

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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not Assigned

Comments:
-The limited available data on use of this drug in pregnant women are insufficient to inform a drug-associated risk.
-Findings in animals reveal increased stillbirths and postnatal offspring mortalities, and delayed fetal development.
-Advise pregnant patients of the potential risk to a fetus.

See references

Based on animal findings, breastfeeding is not recommended during treatment and for 5 days after the final dose.

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

Comments:
-Animal data reveal increased perinatal mortality in exposed fetuses and offspring.
-The effects in the nursing infant and on milk production are unknown.

This drug and its metabolites have been detected in animal milk at concentrations higher than in plasma following oral administration at doses 0.1 to 1.2 times the maximum recommended human dose.

See references