Label Changes for:

Vytorin (ezetimibe/simvastatin) tablets

November 2009

Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

ADVERSE REACTIONS

Post-Marketing Experience
  • erythema multiforme

PATIENT PACKAGE INSERT

What are the possible side effects of Vytorin?
  • Raised red rash, sometimes with target-shaped lesions
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