Label Changes for:

Avodart (dutasteride) Soft Gelatin Capsules

March 2008

Changes have been made to the CONTRAINDICATIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT 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 Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

ADVERSE REACTIONS

  • Postmarketing Experience
    • Immune System Disorders
      • Serious Skin Reactions
      • Angioedema

PATIENT PACKAGE INSERT

  • How should I take Avodart?
    • Swallow the capsule whole because the contents of the capsule may irritate your lips, mouth, or throat.

CONTRAINDICATIONS

...Avodart is contraindicated for patients with known hypersensitivity (e.g., angioedema) to dutasteride, other 5α-reductase inhibitors, or any component of the preparation.

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