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U.S. Department of Health and Human Services

Safety

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Exforge (amlodipine and valsartan) tablets

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

 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Vascular: Vasculitis

DRUG INTERACTIONS

Clinical Laboratory Findings
  • Neutropenia: Neutropenia was observed in 1.9% of patients treated with Diovan and 0.8% of patients treated with placebo.