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U.S. Department of Health and Human Services


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Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) 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


Sections Modified

Summary of Changes to Contraindications and Warnings


  • Reduction in Bone Mineral Density


  • Reduction in Bone Mineral Density
    • 2-Year Fluticasone Propionate Study
    • 3-Year Bone Mineral Density Study
    • 3-Year Survival Study


The latest label (3/31/2009) is not available on this site