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Label Changes for:

Seroquel (quetiapine fumarate) Tablets

January 2008

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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


  • Leukopenia, Neutropenia and Agranulocytosis
  • Information for Patients
  • Laboratory Tests


  • Vital Signs and Laboratory Studies
    • In postmarketing clinical trials, elevations in total cholesterol (predominantly LDL cholesterol) have been observed.
  • Postmarketing Experience
    • Cardiomyopathy
    • Myocarditis

January 2008 Label not available at this site.