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Pimozide Pregnancy and Breastfeeding Warnings

Pimozide is also known as: Orap

Medically reviewed on May 23, 2018

Pimozide Pregnancy Warnings

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

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

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Orap Tablets (pimozide)." Gate Pharmaceuticals, Sellersville, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Orap Tablets (pimozide)." Gate Pharmaceuticals, Sellersville, PA.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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