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Label Changes for:

Lexiva (fosamprenavir calcium) Tablets and Oral Suspension

April 2008

Changes have been made to the 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) -- April 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


  • Postmarketing Experience
    • Skin and Subcutaneous Tissue Disorders
      • Angioedema


  • What are the possible side effects of Lexiva?
    • ...Swelling of the face, lips, and tongue (angioedema) has also been reported. Tell your healthcare provider if you get a rash or develop facial swelling after starting Lexiva.

The April 2008 Label not available at this site.