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U.S. Department of Health and Human Services

Safety

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Uroxatral (alfuzosin HCl extended-release tablets) September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 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. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

WARNINGS

The following sentence was added to the WARNINGS section:

There may be an increased risk of hypotension/postural hypotension and syncope when taking Uroxatral concomitantly with anti-hypertensive medication or nitrates.