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U.S. Department of Health and Human Services

Safety

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Uroxatral (alfuzosin HCl extended-release tablets)


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

ADVERSE REACTIONS

  • 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