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

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)

 

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