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U.S. Department of Health and Human Services


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Seroquel (quetiapine fumarate) Tablets May 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 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


  • Clinical Study Experience
    • Extrapyramidal Symptoms
      • Dystonia - Class Effect
  • Postmarketing Experience
    • Anaphylactic Reaction
    • Restless Legs


  • P450 3A Inhibitors
    • Protease Inhibitors