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Ondansetron Pregnancy and Breastfeeding Warnings

Brand names: Zofran, Zofran ODT, Zuplenz

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Ondansetron Pregnancy Warnings

Use is not recommended (AU, UK)
This drug should be used during pregnancy only if clearly needed (US)

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comment:
-If use is absolutely necessary, caution should be exercised, especially during the first trimester.

Animal studies have failed to reveal evidence of harm to the embryo, fetus, gestation period, perinatal/postnatal development, and/or fertility. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Ondansetron Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug (AU, UK)
Use with caution (US)

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. Product Information. Zofran (ondansetron). GlaxoSmithKline. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. Product Information. Zuplenz (ondansetron). Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc. 2010.

References for breastfeeding information

  1. Product Information. Zofran (ondansetron). GlaxoSmithKline. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. Product Information. Zuplenz (ondansetron). Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc. 2010.
  5. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 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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