Fenofibrate: Side Effects, Uses & Monitoring
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 hype
- Data source
- FDA labeling via NIH DailyMed (label 90970ff4…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 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 reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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…
Conditions associated with Fenofibrate in labeling
Hyperlipidemia
Elevated levels of cholesterol or triglycerides in the blood, a major risk factor for heart attack and stroke....
Hypothyroidism
A condition in which the thyroid gland does not produce enough thyroid hormone, slowing metabolism and affecti...
Pancreatitis
Inflammation of the pancreas that causes severe upper abdominal pain radiating to the back, nausea, and vomiti...
Frequently Asked Questions
What is Fenofibrate used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Fenofibrate?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Fenofibrate. Individual risk varies.
Does Fenofibrate require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Fenofibrate.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.