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Label Changes for:

Viread (tenofovir disoproxil fumarate) Tablets

May 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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 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