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HMG-CoA reductase inhibitor (statin) Pregnancy: Contraindicated in pregnancy and breast-feeding (US labelling: Pregnancy Category X). Women of childbearing potential must use effective contraception; discontinue if pregnancy occurs.

Fluvastatin

Brand names: Lescol

Fluvastatin is an HMG-CoA reductase inhibitor (statin) used to lower LDL-cholesterol in primary hypercholesterolaemia and mixed dyslipidaemia and for cardiovascular risk reduction.

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: 20 to 80 mg/day
Route: Oral
Frequency: Once daily in the evening (or 40 mg twice daily; 80 mg prolonged-release tablet once daily)
Max: 80 mg/day
Dyslipidaemia (adults): place on a standard cholesterol-lowering diet first. Recommended dosing range 20-80 mg/day, individualised to baseline LDL-C and treatment goal. For LDL-C reduction goal below 25%, a starting dose of 20 mg as one capsule in the evening may be used; for a goal of 25% or more, the recommended starting dose is 40 mg as one capsule in the evening. May be up-titrated to 80 mg daily as a single 80 mg prolonged-release tablet (any time of day) or one 40 mg capsule twice daily. Maximum lipid-lowering effect achieved within 4 weeks; adjust doses at intervals of 4 weeks or more. Secondary prevention in coronary heart disease after percutaneous coronary intervention: 80 mg daily. Paediatric (children and adolescents aged 9 years and older with heterozygous familial hypercholesterolaemia): standard cholesterol-lowering diet first; recommended starting dose one 20 mg capsule, adjusted at 6-week intervals, maximum 80 mg/day (40 mg twice daily or one 80 mg prolonged-release tablet once daily); only investigated in children 9 years and older. No per-kg dose stated. Can be taken with or without meals; swallow whole.

Dose adjustments

Renal

No dose adjustments necessary in mild to severe renal insufficiency; however, due to limited experience with doses above 40 mg/day in severe renal impairment (CrCl below 0.5 mL/sec or 30 mL/min), these doses should be initiated with caution.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known hypersensitivity to fluvastatin or to any of the excipients
  • Active liver disease, or unexplained persistent elevations in serum transaminases
  • Pregnancy and breast-feeding

Side effects

  • Insomnia (common)
  • Headache (common)
  • Nausea, abdominal pain, dyspepsia (common)
  • Blood creatine phosphokinase increased, blood transaminases increased (common)
  • Myalgia, muscular weakness, myopathy (rare); rhabdomyolysis, myositis (very rare); immune-mediated necrotizing myopathy (not known)

Interactions

  • Fusidic acid (systemic) - must not be co-administered, or within 7 days of stopping fusidic acid (rhabdomyolysis risk); discontinue statin during fusidic acid treatment
  • Ciclosporin - limit fluvastatin to 20 mg twice daily (increased fluvastatin exposure)
  • Fluconazole - limit fluvastatin to 20 mg twice daily (increased fluvastatin exposure)
  • Fibrates or lipid-modifying doses of niacin - increased risk of skeletal muscle effects; weigh benefit and risk
  • Cholestyramine or other resins - administer fluvastatin at least 4 hours after the resin
  • Warfarin/coumarin derivatives and phenytoin - monitor prothrombin time / phenytoin levels when fluvastatin is started, stopped or dose changed

Clinical monograph

How it works

It competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis, which upregulates LDL receptors and increases clearance of LDL-cholesterol from the circulation.

Prescribing in practice

  • It is contraindicated in active liver disease or unexplained persistent elevations in serum transaminases, and in pregnancy and breast-feeding.
  • Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness because of the risk of myopathy and rhabdomyolysis.
  • Review concurrent medicines for interactions, as the risk of muscle toxicity is increased by certain interacting drugs and the statin should not be combined with gemfibrozil.

Monitoring

Check liver function before starting and as clinically indicated thereafter, and measure creatine kinase if a patient reports significant muscle symptoms.

Counselling the patient

  • Take the dose as directed, typically in the evening, and continue a cholesterol-lowering diet.
  • Report any unexplained muscle pain, tenderness or weakness without delay.
  • Avoid this medicine if you become pregnant and discuss contraception if relevant.

Evidence & guidelines

Statins as a class have robust randomised trial evidence for reducing cardiovascular events, and NICE recommends statin therapy for primary and secondary cardiovascular prevention.

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.