Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg January 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 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. Read about the new physician labeling format.

Summary View

 

Sections Modified	Summary of Changes to Contraindications and Warnings
WARNINGS AND PRECAUTIONS	(5.4) Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions