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