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U.S. Department of Health and Human Services

Safety

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Viread (tenofovir disoproxil fumarate) 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

  • Adverse Reactions from Clinical Trials Experience
  • Treatment-Naive Patients
  • Study 934 - Treatment Emergent Adverse Reactions
    • Table 4
  • Laboratory Abnormalities
    • Table 5

 

Label approved 05/16/2008 is not available on Drugs@FDA