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Cevimeline Pregnancy and Breastfeeding Warnings

Brand names: Evoxac

Medically reviewed by Drugs.com. Last updated on Jul 28, 2025.

Cevimeline Pregnancy Warnings

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

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of a reduction in the mean number of implantations. There are no controlled data in human pregnancy.

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

Cevimeline Breastfeeding Warnings

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: Data not available

Comments: The effects in the nursing infant are unknown.
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See references

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References for pregnancy information

  1. (2001) "Product Information. Evoxac (cevimeline)." Daiichi Pharmaceuticals
  2. (2018) "Product Information. Evoxac (cevimeline)." Cosette Pharmaceuticals Inc

References for breastfeeding information

  1. (2001) "Product Information. Evoxac (cevimeline)." Daiichi Pharmaceuticals

Further information

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