Alfuzosin Pregnancy and Breastfeeding Warnings

Brand names: Uroxatral

Alfuzosin Pregnancy Warnings

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.

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.

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