Label Changes for:

Zetia (ezetimibe) Tablets

January 2012

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

January 2012

8 USE IN SPECIFIC POPULATIONS

8.6 Renal Impairment subsection [new]
  • reflect the results of the Study of Heart and Renal Protection (SHARP) trial

 

 

July 2009

 

ADVERSE REACTIONS

Postmarketing Experience
  • abdominal pain and headache
  • erythema multiforme

PATIENT PACKAGE INSERT

What are the possible side effects of Zetia?
  • abdominal pain and headache
  • erythema multiforme

 

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