Fibricor® (fenofibric acid) is an oral tablet, prescription medicine, approved by the U.S. Food and Drug Administration (FDA) to be used in connection with diet for the treatment of severely high levels of triglycerides in the blood, to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
The effect of Fibricor on coronary heart disease morbidity, mortality and non-cardiovascular mortality has not been established.
- Fibricor should not be used by patients with severe renal dysfunction (including those on dialysis), or by nursing mothers, or by patients with hypersensitivity to fenofibric acid or fenofibrate, the active ingredient in Fibricor.
- Liver function should be monitored periodically.
- Renal function should be monitored periodically in patients with renal insufficiency.
- Tell your doctor if you are also taking coumarin anticoagulants. Caution should be exercised in taking Fibricor and coumarin-type anticoagulants at the same time.
- The most common adverse reactions (>2% and greater than placebo) are increased liver function tests, abdominal pain, back pain and headache.
This product information is intended only for residents of the United States.