Fenofibrate: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Fenofibrate. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Respiratory disorder | 6.2% |
| Abdominal pain | 4.6% |
| Diarrhea | 4.1% |
| Back pain | 3.4% |
| Headache | 3.2% |
| Asthenia | 3% |
| Sgpt increased | 3% |
| Creatine phosphokinase increased | 3% |
| Flu syndrome | 2.7% |
| Nausea | 2.3% |
| Rhinitis | 2.3% |
| Constipation | 2.1% |
| Liver function tests abnormal | 1.4% |
| Sgot increased | 0.5% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Treatment of Hypercholesterolemia Fenofibrate tablets, USP are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (See National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate tablet, USP therapy on reducing this risk has not been adequately studi…
Medical disclaimer: Always consult a qualified healthcare professional about any medication.