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U.S. Department of Health and Human Services


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Cordarone (amiodarone HCl) tablets

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


January 2014

Summary View


Postmarketing Reports
  • added: acute respiratory distress syndrome in the post-operative setting


November 2011


Drug Interactions
HMG-CoA reductase inhibitors:
  • Limit the dose of simvastatin in patients on amiodarone to 20 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as amiodarone may increase the plasma concentration of these drugs.


December 2010

Summary View 


Postmarketing Reports
  • drug rash with eosinophilia and systemic symptoms (DRESS)