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Label Changes for:

Simcor (niacin extended release/simvastatin) Tablets

February 2011

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) – February 2011



Postmarketing Experience
  • ...Erectile dysfunction, depression, interstitial lung disease, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), muscle cramps, vomiting, malaise