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Label Changes for:

Fibricor (Fenofibric Acid) Tablets

December 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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


December 2012



Skeletal Muscle
  • Fibrates increase the risk for myopathy and have been associated with rhabdomyolysis…
Paradoxical Decreases in HDL Cholesterol Levels
  • There have been postmarketing and clinical trial reports of severe decreases in HDL cholesterol levels (as low as 2 mg/dL) occurring in diabetic and non-diabetic patients initiated on fibrate therapy…