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Dolasetron Pregnancy and Breastfeeding Warnings

Brand names: Anzemet

Medically reviewed by Drugs.com. Last updated on Dec 15, 2023.

Dolasetron Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

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

Animal studies have failed to reveal evidence of teratogenicity or impaired 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

Dolasetron Breastfeeding Warnings

AU: Use is not recommended.
US: Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

When animal models were given the oral formulation of this drug, survival, growth, and development of pups were not affected.

See references

See also

References for pregnancy information

  1. (2001) "Product Information. Anzemet (dolasetron)." Hoechst Marion Roussel
  2. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Anzemet (dolasetron)." Hoechst Marion Roussel
  2. Cerner Multum, Inc. "Australian Product Information."

Further information

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

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