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Fibrate / PPAR-α agonist Pregnancy: Contraindicated in pregnancy (no data on use in human pregnancy) and contraindicated in nursing mothers (§4.3/§4.6).

Ciprofibrate

Brand names: Modalim

Ciprofibrate is a fibrate lipid-regulating drug used in the management of dyslipidaemias, particularly where hypertriglyceridaemia is prominent.

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: 100 mg (one tablet)
Route: oral
Frequency: once daily
Max: 100 mg daily — 'This dose should not be exceeded' (§4.2). §4.4: doses of 200 mg ciprofibrate per day or greater have been associated with a high risk of rhabdomyolysis, therefore the daily dose should not exceed 100 mg.
SPC §4.2 (Ciprofibrate 100mg Tablets): 'Adults — The recommended dosage is one tablet (100mg ciprofibrate) per day.' Elderly: as for adults, but see Precautions and Warnings. Use in Children: not recommended since safety and efficacy in children has not been established. For oral administration only. §4.4 monitoring/safety: patients should be advised to report unexplained muscle pain, tenderness or weakness immediately and CPK should be assessed immediately; discontinue if myopathy is diagnosed or if CPK exceeds 5 times the normal range. Risk of myopathy may be increased with impaired renal function or hypoalbuminaemia (e.g. nephrotic syndrome), hypothyroidism, alcohol abuse, age >70 years, personal/family history of hereditary muscular disorders, or previous muscular toxicity with another fibrate. Periodic hepatic function tests are recommended (every 3 months for the first 12 months); discontinue if AST/ALT rise to more than 3 times the upper limit of normal or if cholestatic liver injury is evidenced. Concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR. Secondary causes of dyslipidaemia (e.g. hypothyroidism) should be excluded or corrected before starting. Tablets contain lactose.

Dose adjustments

Renal

In moderate renal impairment it is recommended that dosage be reduced to one tablet (100 mg) every other day, with careful patient monitoring. Ciprofibrate should not be used in severe renal impairment (§4.2/§4.3).

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.

Contraindications

  • Severe hepatic impairment
  • Severe renal impairment
  • Pregnancy and lactation, or when pregnancy is suspected
  • Concurrent use with another fibrate
  • Hypersensitivity to the active substance or to any component of the product

Side effects

  • Musculoskeletal: myalgia, elevation of serum creatine phosphokinase, myopathy, myositis, rhabdomyolysis
  • Gastrointestinal: nausea, vomiting, diarrhoea, dyspepsia, abdominal pain
  • Nervous system: headache, dizziness, somnolence, vertigo
  • Skin: rash, alopecia, urticaria, pruritus, photosensitivity reaction, eczema
  • Hepatobiliary: abnormal liver function tests, cholestasis, cytolysis, cholelithiasis
  • General: fatigue; also thrombocytopenia, erectile dysfunction, pneumonitis and pulmonary fibrosis reported

Interactions

  • Other fibrates — contraindicated combination; risk of rhabdomyolysis and myoglobinuria may be increased
  • HMG CoA reductase inhibitors (statins) — not recommended; risk of myopathy, rhabdomyolysis and myoglobinuria may be increased, benefits of combined use should be carefully weighed against the risks
  • Oral anticoagulants — concomitant therapy should be given at reduced dosage and adjusted according to INR (§4.4)
  • NOTE: the fetched §4.5 was truncated at the source-fetch limit — further interactions listed in the SPC were NOT retrieved and must be checked against the full SPC

Clinical monograph

How it works

As a PPAR-alpha agonist it enhances lipoprotein lipase activity and fatty acid oxidation, lowering triglycerides and tending to raise HDL-cholesterol.

Prescribing in practice

  • Fibrates can cause myositis and rhabdomyolysis; risk is increased in renal impairment and when combined with a statin, so counsel on muscle symptoms and use combinations cautiously.
  • Avoid in significant hepatic or renal impairment and in gallbladder disease, as fibrates may increase the lithogenicity of bile.
  • May potentiate the effect of coumarin anticoagulants, requiring closer monitoring of anticoagulation.

Monitoring

Monitor the lipid profile for response, with liver function and renal function checks and creatine kinase if muscle symptoms occur.

Counselling the patient

  • Report unexplained muscle pain, tenderness or weakness promptly.
  • Continue dietary measures alongside the medicine.
  • Tell your clinician about any blood-thinning medicines you take.

Evidence & guidelines

Fibrates reduce triglycerides and are recommended by NICE chiefly for severe hypertriglyceridaemia rather than as first-line agents for cardiovascular risk reduction.

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.