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Bethanechol Pregnancy and Breastfeeding Warnings

Brand names: Duvoid, Myotonachol, Urecholine

Medically reviewed by Drugs.com. Last updated on Jul 24, 2025.

Bethanechol Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B2
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 not been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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

Bethanechol 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: If used during breastfeeding, monitor the infant for signs of cholinergic excess (e.g., diarrhea, lacrimation, excessive salivation or urination), especially in younger, exclusively breastfed infants.

In animal studies, cholinergic drugs increase oxytocin release and have variable effects on serum prolactin.

See references

Does Bethanechol interact with my other drugs?

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See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2018) "Product Information. Bethanechol Chloride (bethanechol)." Wockhardt USA Inc
  4. (2025) "Product Information. Bethanechol Chloride (bethanechol)." Upsher-Smith Laboratories LLC

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  4. (2018) "Product Information. Bethanechol Chloride (bethanechol)." Wockhardt USA Inc

Further information

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

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