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Alfuzosin Pregnancy and Breastfeeding Warnings

Alfuzosin is also known as: Uroxatral

Medically reviewed by Drugs.com. Last updated on Jun 26, 2020.

Alfuzosin Pregnancy Warnings

Animal data have failed to reveal evidence of teratogenicity or embryotoxicity at doses up to 3 times the maximum recommended human dose (MRHD) based on body surface area. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.

This drug is not indicated for use in female patients.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk Summary: Inadequate data exists regarding the developmental risk associated with use of this drug in pregnant women.

See references

Alfuzosin Breastfeeding Warnings

This drug is not indicated for use in female patients.

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

See references

References for pregnancy information

  1. "Product Information. Uroxatral (alfuzosin)." sanofi-aventis , Bridgewater, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Xatral (alfuzosin)." Sanofi-Synthelabo Canada Inc, Markham, ON.

References for breastfeeding information

  1. "Product Information. Uroxatral (alfuzosin)." sanofi-aventis , Bridgewater, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Xatral (alfuzosin)." Sanofi-Synthelabo Canada Inc, Markham, ON.

Further information

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