Label Changes for:

Vytorin (ezetimibe/simvastatin) Tablets

June 2008

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) -- June 2008

 

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.


Summary View

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience
    • Vytorin or ezetimibe or simvastatin
      • Paresthesia

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
    • Table 3

PATIENT PACKAGE INSERT

  • What are the possible side effects of Vytorin?
    • The following side effects have been reported in general use with Vytorin or with ezetimibe or simvastatin tablets (tablets that contain the active ingredients of Vytorin):
      • Tingling Sensation (added)

Label approved 06/13/2008 is not available on Drugs@FDA

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