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Fibrate (PPAR-α agonist) Pregnancy: Fertility: there is insufficient information on the effects of bezafibrate tablets on human fertility; animal fertility studies showed no indication of reduced fertility. Pregnancy: there are limited data from the use of bezafibrate in pregnant women; animal studies are insufficient with respect to reproductive toxicity. Bezafibrate 200 mg Film-coated Tablets are not recommended during pregnancy and in women of childbearing potential not using contraception. Lactation: there is insufficient information on the excretion of bezafibrate or its metabolites in human milk; a risk to the suckling child cannot be excluded; a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from bezafibrate therapy.

Bezafibrate

Brand names: Bezalip Mono, Bezalip

Bezafibrate is a fibrate used as a lipid-modifying agent, principally to lower raised triglycerides and to treat mixed dyslipidaemias.

Adult dose

Dose: Adjunct to diet and other non-pharmacological treatment for severe hypertriglyceridaemia (with or without low HDL cholesterol) and for mixed hyperlipidaemia when a statin is contraindicated or not tolerated: one 200 mg film-coated tablet three times a day (equivalent to 600 mg bezafibrate per day)
Route: Oral
Frequency: Three times a day; each tablet swallowed whole with sufficient fluid after a meal
Source: UK SPC §4.2 for Bezafibrate 200 mg Film-coated Tablets (each tablet contains 200 mg bezafibrate, §2). The SPC states the recommended dosage as 'one tablet three times a day, equivalent to 600 mg bezafibrate'; it does not print this as a maximum, so no maxDose is recorded. Occasionally gastro-intestinal symptoms may occur; in susceptible patients a slowly increasing dosage over 5 to 7 days may help to avoid them. The response to therapy is normally rapid, although a progressive improvement may occur over a number of weeks; treatment should be withdrawn if an adequate response has not been achieved within 3 to 4 months. Elderly: physiological reduction of renal function with age — dose should be adjusted on creatinine clearance (see renal table). Children: the SPC says there is at present inadequate information regarding an appropriate dosage in children. SCOPE: this SPC covers the 200 mg immediate-release film-coated tablet only; any modified-release product (e.g. Bezalip Mono) is not covered by this source and is not dosed here.

Dose adjustments

Renal

Contraindicated in dialysis patients. Dose by serum creatinine / creatinine clearance (SPC table, dosage in 200 mg tablets/day): serum creatinine up to 135 micromol/l (creatinine clearance over 60 ml/min) = 3 tablets/day; 136 – 225 micromol/l (60 – 40 ml/min) = 2 tablets/day; 226 – 530 micromol/l (40 – 15 ml/min) = 1 tablet every 1 or 2 days; over 530 micromol/l (less than 15 ml/min) = contraindicated. Also contraindicated in nephrotic syndrome and severe renal failure (serum creatinine > 530 micromol/l; creatinine clearance < 15 ml/min) (§4.2, §4.3).

Hepatic

Contraindicated in significant hepatic disease (other than fatty infiltration of the liver associated with raised triglyceride values) and in gall-bladder diseases with or without cholelithiasis (§4.3). No dose-adjustment schedule is given.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to bezafibrate, other fibrates or any excipient
  • Significant hepatic disease (other than fatty infiltration of the liver associated with raised triglyceride values)
  • Gall-bladder diseases with or without cholelithiasis
  • Nephrotic syndrome and severe renal failure (serum creatinine > 530 micromol/l; creatinine clearance < 15 ml/min); patients undergoing dialysis
  • Combination with HMG CoA reductase inhibitors (statins) in patients with predisposing factors for myopathy
  • Known photoallergic or phototoxic reactions to fibrates

Side effects

  • Gastrointestinal disorders and decreased appetite (common); abdominal pain, constipation, dyspepsia, abdominal distension, diarrhoea, nausea (uncommon); pancreatitis (rare)
  • Myopathy: muscular weakness, myalgia, muscle cramp (uncommon); rhabdomyolysis (very rare, risk increased with higher than recommended doses and impaired renal function)
  • Dizziness, headache (uncommon); peripheral neuropathy, paraesthesia, depression, insomnia (rare)
  • Pruritus, urticaria, photosensitivity reaction, alopecia, rash (uncommon); erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (very rare)
  • Cholestasis (uncommon); cholelithiasis (very rare) — bezafibrate alters the composition of bile
  • Hypersensitivity reactions including anaphylaxis (uncommon)
  • Acute renal failure, raised creatine phosphokinase and blood creatinine, erectile dysfunction (uncommon)
  • Pancytopenia, thrombocytopenic purpura, interstitial lung disease (very rare)

Interactions

  • Coumarin-type anticoagulants — action may be potentiated; reduce the anticoagulant dose by up to 50% and readjust by monitoring blood coagulation
  • Antidiabetic medication including insulin — action may be potentiated; increased monitoring of glycaemic status may be warranted briefly after introduction
  • Ion-exchange resins (e.g. colestyramine) — leave an interval of at least 2 hours between the resin and bezafibrate
  • HMG CoA reductase inhibitors (statins) — increased incidence and severity of myopathy; contraindicated in patients with predisposing factors for myopathy; use with caution otherwise
  • Immunosuppressants in organ transplant patients — reversible impairment of renal function reported; monitor renal function closely
  • MAO inhibitors with hepatotoxic potential — should not be given together with bezafibrate
  • Oestrogens / oestrogen-containing contraceptives — may raise lipid levels; prescribing bezafibrate must be critically considered individually

Monitoring

  • Serum creatinine / creatinine clearance (dose adjustment in renal impairment and the elderly)
  • Signs of myopathy (muscle weakness or pain) and creatine kinase (CPK), especially with a statin or in patients with predisposing factors
  • Response to therapy — withdraw if an adequate response has not been achieved within 3 to 4 months
  • Blood coagulation when given with coumarin-type anticoagulants
  • Glycaemic status when given with antidiabetic medication
  • Renal function in organ transplant patients on immunosuppressants
  • Cholelithic symptoms and signs (appropriate diagnostic procedures if they occur)

Clinical monograph

How it works

It activates peroxisome proliferator-activated receptor alpha (PPAR-alpha), enhancing lipoprotein lipase activity and fatty acid oxidation to reduce triglyceride and VLDL levels.

Prescribing in practice

  • The risk of myopathy and rhabdomyolysis is increased, particularly when combined with a statin or in renal impairment; advise patients to report unexplained muscle pain.
  • Dose reduction or avoidance is required in renal impairment, and it is contraindicated in severe renal and hepatic impairment.
  • May potentiate the effect of oral anticoagulants, necessitating closer monitoring of anticoagulation.

Monitoring

Monitor the lipid profile, renal and hepatic function, and check creatine kinase if muscular symptoms develop.

Counselling the patient

  • Report unexplained muscle pain, tenderness or weakness promptly.
  • Continue dietary measures, and inform your prescriber of all other medicines, particularly blood thinners.

Evidence & guidelines

Bezafibrate is an established fibrate for hypertriglyceridaemia, with its use and cautions described in the SPC.

Reference: SmPC Bezalip Mono; ACCORD Lipid trial NEJM 2010; 362:1563-74; NICE CG181; ESC/EAS Dyslipidaemias 2019; 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.

Pathways