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U.S. Department of Health and Human Services

Safety

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Prozac (fluoxetine capsules, USP)


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

PRECAUTIONS

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