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Label Changes for:

Avodart (Dutasteride) Gelatin Capsules

April 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

 

ADVERSE REACTIONS        

Postmarketing Experience
  • Psychiatric Disorders:  Depressed mood
  • Reproductive System and Breast Disorders: Testicular pain and testicular swelling

 

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