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U.S. Department of Health and Human Services

Safety

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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

ADVERSE REACTIONS

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

DRUG INTERACTIONS

  • P450 3A Inhibitors
    • Protease Inhibitors
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