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
