Label Changes for:
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg
January 2009
Changes have been made to the WARNINGS sections of the safety label.
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. |
| Sections Modified |
Summary of Changes to Contraindications and Warnings |
| WARNINGS AND PRECAUTIONS | (5.4) Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions |
