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Label Changes for:

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg

March 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009

 

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Discontinuation of Treatment with Cymbalta

ADVERSE REACTIONS

  • Other Adverse Reactions observed during the premarketing and postmarketing clinical trial evaluation of Duloxetine
    • Ear and Labyrinth Disorders
      • ... and tinnitus
    • General Disorders and Administration Site Conditions
      • ... gait disturbance
    • Nervous System Disorders
      • ...and poor quality sleep
    • Renal and Urinary Disorders
      • polyuria
    • Reproductive System and Breast Disorders
      • ...and sexual dysfunction
    • Skin and Subcutaneous Tissue Disorders
      • dermatitis contact
  • Postmarketing Spontaneous Reports
    • aggression and anger (particularly early in treatment or after treatment discontinuation)
    • gynecological bleeding
    • muscle spasm
    • restless legs syndrome, seizures upon treatment
      discontinuation
    • tinnitus (upon treatment discontinuation)

MEDICATION GUIDE

  • Toll free number

WARNINGS and PRECAUTIONS

  • Discontinuation of Treatment with Cymbalta
    • words "tapered" and "fatigue" inserted in the section

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