Isentress (raltegravir) Tablets October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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. Read about the new physician labeling format.

Summary View

 

Sections Modified

ADVERSE REACTIONS

• Postmarketing Experience
  • Skin and Subcutaneous Tissue Disorders
    • rash, Stevens-Johnson syndrome

PATIENT PACKAGE INSERT

• What are the possible side effects of Isentress?
  • Other side effects include rash and severe skin reactions (added)