Skip to content
ClinCalc Pro
Menu
Fibrate Pregnancy: No adequate data; use only after careful benefit/risk assessment. Should not be used in nursing mothers.

Fenofibrate

Brand names: Lipantil, Supralip, Fenogal

Fenofibrate is a fibrate (PPAR-alpha agonist) used mainly for hypertriglyceridaemia and mixed dyslipidaemia, typically when triglycerides remain high or as an adjunct to diet and other measures. Statins remain first-line for cardiovascular prevention.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 160 mg once daily.
Route: Oral (swallow whole during a meal)
Frequency: Once daily
Patients currently taking one fenofibrate 200 mg capsule can change to one 160 mg tablet without further dose adjustment. Elderly (≥65 y): no dose adjustment necessary except for decreased renal function. Continue dietary measures; if serum lipids not satisfactorily reduced after e.g. 3 months, consider complementary or different therapy. Not recommended in patients under 18 years (safety and efficacy not established).

Dose adjustments

Renal

Contraindicated if eGFR <30 mL/min/1.73 m². If eGFR 30–59, dose should not exceed 100 mg standard (or 67 mg micronized) once daily; discontinue if eGFR falls persistently below 30.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 160 mg once daily ( 2.2 ). Severe hypertriglyceridemia: Initial dose of 54 to 160 mg once daily. Maximum dose is 160 mg ( 2.3 ). Renally impaired patients: Initial dose of 54 mg once daily ( 2.4 ). Geriatric patients: Select the dose on the basis of renal function ( 2.5 ). Should be given with meals ( 2.1 ). 2.1 General Considerations Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablet USP, and should continue this diet during treatment with fenofibrate tablet USP. Fenofibrate tablets USP should be given with meals, thereby optimizing the bioavailability of the medication. The …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2024-04-29. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hepatic insufficiency (including biliary cirrhosis)
  • Severe renal insufficiency (eGFR <30 mL/min/1.73 m²)
  • Children
  • Hypersensitivity to fenofibrate or any component
  • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
  • Gall bladder disease
  • Chronic or acute pancreatitis (except acute pancreatitis due to severe hypertriglyceridaemia)

Side effects

  • Gastrointestinal disorders (abdominal pain, nausea, vomiting, diarrhoea, flatulence)
  • Moderately elevated serum transaminases
  • Gallstones; pancreatitis (uncommon)
  • Muscle toxicity — diffuse myalgia, myositis, muscular cramps and weakness; rhabdomyolysis (very rare/not known)
  • Increases in serum creatinine and urea

Interactions

  • HMG-CoA reductase inhibitors (statins) — increased risk of muscle toxicity/rhabdomyolysis; co-prescription reserved for severe combined dyslipidaemia at high cardiovascular risk, with close monitoring
  • Other fibrates — increased risk of muscle toxicity
  • (Full §4.5 not present in fetched bundle)

Clinical monograph

How it works

It activates peroxisome proliferator-activated receptor alpha (PPAR-alpha), enhancing lipoprotein lipase activity and fatty-acid oxidation. This lowers serum triglycerides and VLDL and tends to raise HDL-cholesterol.

Prescribing in practice

  • Muscle toxicity (myopathy, and rarely rhabdomyolysis) can occur and the risk is increased when combined with a statin — investigate unexplained muscle pain or weakness and check creatine kinase, with extra caution in renal impairment.
  • Serum creatinine can rise (usually reversible) and the risk of gallstones is increased; avoid in significant hepatic or renal impairment and in gallbladder disease.
  • Monitor liver function, and avoid in pregnancy and breastfeeding; review interacting drugs including anticoagulants (potentiated) and statins.

Monitoring

Check baseline lipids, liver and renal function, and monitor liver function periodically during treatment. Reassess the lipid response, monitor renal function, and measure creatine kinase if muscle symptoms develop; review the need for continued treatment if there is an inadequate response.

Counselling the patient

  • Report promptly any unexplained muscle pain, tenderness or weakness.
  • Seek advice if you develop upper abdominal pain, jaundice or pale stools, which may indicate gallstones or liver problems.
  • Continue dietary and lifestyle measures, and tell us if you become pregnant or are breastfeeding.

Evidence & guidelines

Considered for hypertriglyceridaemia where statins are insufficient or not tolerated (NICE CG181; NICE NG238).

Reference: NICE CG181; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.