Label Changes for:
Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
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.|
- Postmarketing Reports
- Musculoskeletal and connective tissue disorders
- General disorders and administration site conditions
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