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U.S. Department of Health and Human Services

Safety

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Chantix (varenicline)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • There have been reports of myocardial infarction (MI) and cerebrovascular accident (CVA) including ischemic and hemorrhagic events in patients taking Chantix