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U.S. Department of Health and Human Services

Safety

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Niaspan (niacin extended release) tablet March 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009

 

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

ADVERSE REACTIONS

  • Post-marketing adverse event
    • blurred vision, hepatitis, myopathy, creatine kinase increase, and skin discoloration

The latest label (approved 03/26/2009) is not available on this site

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