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Label Changes for:

Symbyax (olanzapine and fluoxetine HCl capsules)

March 2008

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

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


  • General
    • Abnormal Bleeding
    • Hyponatremia
  • Information for Patients
    • Abnormal Bleeding
  • Drug Interactions
    • Drugs that interfere with hemostasis (e.g., NSAIDs, Aspirin, Warfarin)
  • Geriatric Use