Label Changes for:

Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

June 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) -- June 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

  • Postmarketing Reports
  • Musculoskeletal and connective tissue disorders
    • Arthralgia
    • Myalgia
  • General disorders and administration site conditions
    • Asthenia
    • Fatigue
    • Malaise

PATIENT PACKAGE INSERT

  • What are the possible side effects of Gardasil?
    • ...joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell. (added)

Label not available on Drugs@FDA

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