Safety

Daliresp (Roflumilast) Tablets

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

November 2015

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • gynecomastia

 

August 2013

Summary View 

WARNINGS AND PRECAUTIONS

  • Cases of suicidal ideation and behavior, including completed suicide, have been observed in the post-marketing setting in patients with or without a history of depression

 

Page Last Updated: 12/11/2015
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