Animal studies revealed some decrease in conception rate and litter size, and an increase in resorption rate. However, animal studies and clinical experience to date have not demonstrated any teratogenic effects. There are no controlled data in human pregnancy.

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. Such complications have varied in severity - symptoms have been self-limited in some while others required intensive care unit support and prolonged hospitalization.

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.

Safety has not been established during pregnancy; use is recommended only when the expected benefits outweigh the possible risks to mother and fetus.

US FDA pregnancy category: Not Assigned

See references

-The manufacturer makes no recommendation regarding use during lactation.
-Consider using other antipsychotic agents since there is no published experience with this drug during breastfeeding.

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

Comments: This drug has caused galactorrhea due to hyperprolactinemia. However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

See references