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Bethanechol Pregnancy and Breastfeeding Warnings

Brand names: Duvoid, Myotonachol, Urecholine

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Bethanechol Pregnancy Warnings

Use should be avoided unless clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Animal reproduction studies have not been reported. It is unknown if this drug can cause fetal harm or affect reproduction capacity. 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 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.

See references

Bethanechol Breastfeeding Warnings

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

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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Product Information. Bethanechol Chloride (bethanechol). Wockhardt USA Inc. 2018.

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. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  4. Product Information. Bethanechol Chloride (bethanechol). Wockhardt USA Inc. 2018.

Further information

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