Medication Guide App

Label Changes for:

Viread (tenofovir disoproxil fumarate) Tablets

August 2008

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 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 Summary of Changes to Contraindications and Warnings

BOXED WARNING

WARNINGS AND PRECAUTIONS

  • Exacerbation of Hepatitis after Discontinuation of Treatment
  • Coadministration with Other Products
  • Patients Coinfected with HIV-1 and HBV
  • Decreases in Bone Mineral Density
  • Fat Redistribution
  • Immune Reconstitution Syndrome

ADVERSE REACTIONS

  • Adverse Reactions from Clinical Trials Experience
    • Clinical Trials in Patients with Chronic Hepatitis B
      • Treatment-Emergent Adverse Reactions
      • Laboratory Abnormailities
    • Table 8 (and text following Table 8)
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