Pimozide Pregnancy and Breastfeeding Warnings

Brand names: Orap

Medically reviewed by Drugs.com. Last updated on Jul 30, 2025.

Pimozide Pregnancy Warnings

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

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

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).

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.

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.

See references

Pimozide Breastfeeding Warnings

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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