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Crofelemer Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Mar 21, 2023.

Crofelemer is also known as: Fulyzaq, Mytesi

Crofelemer Pregnancy Warnings

Animal reproduction studies showed no impaired fertility, harm to the fetus, or adverse prenatal and postnatal effects in offspring at oral doses up to 177 times the recommended daily human dose. Abortions and resorptions of fetuses occurred in pregnant animals at oral doses of about 96 times the recommended daily human dose, but these effects could be related to maternal toxicity.

There are no controlled data in human pregnancy.

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.

Use only if clearly needed.

FDA pregnancy category: C

See references

Crofelemer Breastfeeding Warnings

A decision should be made to discontinue breast-feeding 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

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Fulyzaq (crofelemer)." Salix Pharmaceuticals (2013):

References for breastfeeding information

  1. "Product Information. Fulyzaq (crofelemer)." Salix Pharmaceuticals (2013):

Further information

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