Animal study data showed in decreased pregnancies and retarded development in fetuses, which may have resulted from an inhibition/delay in implantation. Dose-related maternal toxicity, mortality, decreased weight gain, and embryotoxicity with resorption also occurred in animal models. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit clearly outweighs the risk (US).
Safety has not been established during pregnancy; use should be avoided during the first trimester of pregnancy (UK).

US FDA pregnancy category: C

Comment:
-Neonates exposed during the third trimester should be closely monitored, as they are at risk of extrapyramidal/withdrawal symptoms after delivery (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder).

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: Unknown
Excreted into animal milk: Unknown

Comment:
-The effects in the nursing infant are unknown.

This drug may cause hyperprolactinemia, which could result in galactorrhea, amenorrhea, and/or gynecomastia.

See references