Zetia (ezetimibe) Tablets June 2008

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
  • Paresthesia

USE IN SPECIFIC POPULATIONS

• Pediatric Use
  • Table 3

PATIENT PACKAGE INSERT

• What are the possible side effects of Zetia?
  • Tingling Sensation (added)