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Ondansetron Pregnancy and Breastfeeding Warnings

Brand names: Zofran, Zofran ODT, Zuplenz

Medically reviewed by Drugs.com. Last updated on Sep 24, 2024.

Ondansetron Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: B1
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 failed to reveal evidence of fetal harm. 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 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

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

Does Ondansetron interact with my other drugs?

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See also

References for pregnancy information

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

References for breastfeeding information

  1. (2001) "Product Information. Zofran (ondansetron)." GlaxoSmithKline
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2010) "Product Information. Zuplenz (ondansetron)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc.
  5. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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

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