In animal studies, oral administration of this drug to pregnant rats and rabbits during the period of organogenesis caused toxicities only at doses of at least 6 times the maximum recommended human dose. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-888-274-2378.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: There are no available data on the use of this drug in pregnant women to evaluate risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Comment: A pregnancy exposure registry is available.

See references

This drug should not be used unless there are no safer alternatives.

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

Comment: Infants exposed to this drug through breastmilk should be monitored for excessive sedation.

This drug and its metabolites are present in the milk of lactating rats, so it is likely that it will be present in human milk.

See references