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. |
Sections Modified
ADVERSE REACTIONS
- Postmarketing Experience
- Vytorin or ezetimibe or simvastatin
- Paresthesia
- Vytorin or ezetimibe or simvastatin
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)
- 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):
Label approved 06/13/2008 is not available on Drugs@FDA
