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Anastrozole Pregnancy and Breastfeeding Warnings

Brand names: Arimidex

Medically reviewed by Drugs.com. Last updated on Aug 9, 2023.

Anastrozole Pregnancy Warnings

Use is not recommended.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: Based on animal findings and its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to treatment.
-Female patients of reproductive potential should be advised to use effective contraception during therapy and for at least 3 weeks after the last dose.
-Female fertility may be compromised by this drug.
-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 harm to the fetus.

Animal studies have revealed pregnancy failures, increased pregnancy loss, signs of delayed fetal development, significant incidences of infertility, and adverse effects on reproductive organs. However, there was no evidence of teratogenicity in animal data. There are no controlled data in human pregnancy.

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 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

Anastrozole Breastfeeding Warnings

Use should be avoided.
-According to some authorities: Use is contraindicated.

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

Comments:
-Female patients should not to breastfeed during treatment and for at least 2 weeks after the last dose.
-The effects in the nursing infant or milk production are unknown.

See references

See also

References for pregnancy information

  1. (2001) "Product Information. Arimidex (anastrozole)." Astra-Zeneca Pharmaceuticals
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Arimidex (anastrozole)." Astra-Zeneca Pharmaceuticals
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. 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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