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Nilutamide Pregnancy and Breastfeeding Warnings

Brand names: Nilandron

Medically reviewed by Drugs.com. Last updated on May 5, 2025.

Nilutamide Pregnancy Warnings

This drug is not indicated for use in female patients.

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

Risk summary: This drug is not indicated for use in female patients. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

There are insufficient animal toxicity data. There are no controlled data in human pregnancy.

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

Nilutamide Breastfeeding Warnings

This drug is not indicated for use in female patients.

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

Comments: The effects in the nursing infant are unknown.

See references

Does Nilutamide interact with my other drugs?

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See also

References for pregnancy information

  1. (2001) "Product Information. Nilandron (nilutamide)." Hoechst Marion Roussel
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2025) "Product Information. Nilandron (nilutamide)." Concordia Pharmaceuticals

References for breastfeeding information

  1. (2001) "Product Information. Nilandron (nilutamide)." 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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