Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin

Am J Cardiol. 2005 Jan 1;95(1):120-2. doi: 10.1016/j.amjcard.2004.08.076.


There is an increasing trend among physicians to use 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) in combination with other antilipidemic agents. The complementary lipid-altering effects of statins and fibric acid derivatives (fibrates) have led to an increasing use of statin/fibrate combination therapy, particularly for patients who have mixed dyslipidemia. Clinical experience indicates that there may be an increased risk of myotoxicity associated with statin/fibrate combination therapy. However, it is not known whether there are differences in the rate of myotoxicity between the use of fenofibrate and gemfibrozil in combination with statins. To evaluate this question, data from the United States Food and Drug Administration's Adverse Event Reporting System was reviewed to determine how many adverse events were reported for patients who were being treated concomitantly with statins and fibrates. The findings suggest that the use of fenofibrate in combination with statins results in fewer reports of rhabdomyolysis per million prescriptions dispensed than does the use of gemfibrozil.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Drug Therapy, Combination
  • Fenofibrate / administration & dosage
  • Fenofibrate / adverse effects*
  • Gemfibrozil / administration & dosage
  • Gemfibrozil / adverse effects*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Hypolipidemic Agents / administration & dosage
  • Hypolipidemic Agents / adverse effects*
  • Retrospective Studies
  • Rhabdomyolysis / chemically induced*
  • Rhabdomyolysis / epidemiology
  • United States
  • United States Food and Drug Administration


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Hypolipidemic Agents
  • Gemfibrozil
  • Fenofibrate