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

US FDA pregnancy category: Not formally assigned to a pregnancy category.

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.

Animal data studies have failed to reveal evidence of teratogenicity. 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.

See references

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-The effects in the nursing infant are unknown.
-Some experts state that alternative agents (e.g., haloperidol, olanzapine) may be preferred, especially when breastfeeding a preterm infant or newborn.

See references