Safety in pregnancy has not been established.

US FDA pregnancy category: Not assigned.

Risk summary: No data are available on use of this drug in pregnant women to inform a drug-related risk.

Comment: It is unknown if this drug crosses the placenta, but its molecular weight (about 389 for the free base) suggests that exposure to the embryo-fetus should be expected.

Animal studies failed to reveal any evidence of teratogenicity. Increased resorptions and stillborn pups were observed, but these adverse effects occurred in only 1 to 2 dams in each study. There are no controlled data in human pregnancy.

Some data show no adverse effects in fetuses when this drug was used in pregnancy to treat nausea and vomiting. However, a study of 193 pregnant patients treated with this drug in the 1st trimester showed incidences of severe congenital defects at 1 month (2.6%), 1 year (2.6%), and 5 years (5.8%); the study authors determined that there is a low risk of congenital malformations since other factors (including the use of other antiemetics in some patients) may have contributed to the results.

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.

See references

Safety in nursing mothers has not been established.

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

Comments: The drug molecular weight (about 389 for the free base) is low enough that excretion into breast milk should be expected; the effects in the nursing infant are unknown.

See references