Animal reproduction studies have not been conducted with this drug. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not formally assigned

Risk Summary: Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.

Comment:
-Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

See references

Use is not recommended and 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: Yes

Comment: Infants should be monitored for drowsiness and developmental milestones.

See references