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U.S. Department of Health and Human Services

Safety

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Daliresp (Roflumilast) Tablets

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