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U.S. Department of Health and Human Services

Safety

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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)