Animal models have revealed evidence of dilated cerebral ventricles, skeletal defects, and reductions in fetal weight and length. Abnormal sperm and chromosomal aberrations have occurred in male animals receiving antipsychotic agents, and depression of spermatogenesis occurred at high doses. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

AU TGA pregnancy category: C
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.

Comments:
-The dose and duration of treatment in pregnant patients should be as low and short as possible.
-Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

See references

Use is not recommended.

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

Comments:
-The American Academy of Pediatrics considers use of this drug during lactation "unknown but may be of concern."
-Breastfed infants exposed to this drug should be monitored for sedation and developmental milestones.

This drug may cause hyperprolactinemia and galactorrhea, which could impair lactation.

See references