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Label Changes for:

Uroxatral (alfuzosin HCl extended-release tablets)

May 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View

Sections Modified


  • Postmarketing Adverse Event Reports
    • Hepatobiliary Disorders
      • Hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation)

Label approved 05/06/2008 is not available on Drugs@FDA