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Exemestane Pregnancy and Breastfeeding Warnings

Exemestane is also known as: Aromasin

Medically reviewed on August 30, 2016

Exemestane Pregnancy Warnings

Use is contraindicated in women who are or may become pregnant.

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

Comments: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the potential risk for pregnancy loss.

Animal studies have revealed exemestane to be embryotoxic, fetotoxic, and abortifacient. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Exemestane Breastfeeding Warnings

Use is contraindicated in lactating women.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Aromasin (exemestane)" Pharmacia & Upjohn, Kalamazoo, MI.

References for breastfeeding information

  1. "Product Information. Aromasin (exemestane)" Pharmacia & Upjohn, Kalamazoo, MI.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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