Lipid-Lowering Agent Pregnancy: Contraindicated in pregnancy and lactation. Women of childbearing potential should use appropriate contraceptive measures; if a patient becomes pregnant during use, treatment should be discontinued immediately.

Rosuvastatin

Brand names: Crestor

Rosuvastatin is an HMG-CoA reductase inhibitor (statin) used to lower LDL-cholesterol in dyslipidaemia and for primary and secondary cardiovascular prevention. It is relatively hydrophilic and undergoes little CYP450 metabolism, so it has fewer interactions than simvastatin or atorvastatin.

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: Hypercholesterolaemia: 5 mg or 10 mg orally once daily as the start dose (in both statin-naive patients and patients switched from another HMG-CoA reductase inhibitor); a dose adjustment to the next dose level can be made after 4 weeks if necessary

Route: Oral — may be given at any time of day, with or without food

Frequency: Once daily

Max: 40 mg once daily — final titration to 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular familial hypercholesterolaemia) who do not achieve their treatment goal on 20 mg and in whom routine follow-up will be performed; specialist supervision is recommended when the 40 mg dose is initiated

eMC SPC for Rosuvastatin 10 mg film-coated tablets. Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet, continued during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines. Prevention of cardiovascular events: in the cardiovascular events risk reduction study the dose used was 20 mg daily. Start dose 5 mg is recommended in patients over 70 years, in patients of Asian ancestry (40 mg contraindicated in these patients), in patients with predisposing factors to myopathy, and in moderate renal impairment. A lower daily dose is recommended for patients known to have specific genetic polymorphisms that increase rosuvastatin exposure. Hepatic impairment: no increase in systemic exposure with Child-Pugh score 7 or below; increased exposure at Child-Pugh 8 and 9 (consider assessing renal function); no experience above Child-Pugh 9; contraindicated in active liver disease. Concomitant therapy: risk of myopathy/rhabdomyolysis is increased with medicines that raise rosuvastatin plasma concentrations (e.g. ciclosporin and certain protease inhibitors including ritonavir combined with atazanavir, lopinavir and/or tipranavir) — consider alternatives or temporary discontinuation of rosuvastatin, and careful dosing adjustment where co-administration is unavoidable. PAEDIATRIC (specialist use only; not structured below because the SPC dose is age-band based, not per-kg): children and adolescents 6 to 17 years with heterozygous familial hypercholesterolaemia — usual start dose 5 mg daily; usual range 5-10 mg once daily in children 6 to 9 years (doses above 10 mg not studied) and 5-20 mg once daily in children 10 to 17 years (doses above 20 mg not studied). Homozygous familial hypercholesterolaemia in children 6 to 17 years — recommended maximum 20 mg once daily, starting at 5 to 10 mg once daily depending on age, weight and prior statin use. The 40 mg tablets are not suitable for paediatric patients. Not recommended in children younger than 6 years (safety and efficacy not studied). Clinician to verify all paediatric dosing against a children's formulary.

Dose adjustments

Renal

No dose adjustment in mild to moderate renal impairment, but the recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance < 60 ml/min) and the 40 mg dose is contraindicated in these patients. Use is contraindicated at all doses in patients with severe renal impairment (creatinine clearance < 30 ml/min).

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.

US labelling (FDA)

Reference — US labelling, may differ from UK

Take orally with or without food, at any time of day. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. ( 2.1 ) Adults : Recommended dosage range is 5 to 40 mg once daily. ( 2.1 ) Pediatric Patients with HeFH : Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. ( 2.2) Pediatric Patients with HoFH : Recommended dosage is 20 mg once daily for patients aged 7 years and older. ( 2.2 ) Asian Patients : Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-11-26. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to rosuvastatin or to any of the excipients
Active liver disease, including unexplained persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x ULN
Severe renal impairment (creatinine clearance < 30 ml/min)
Myopathy
Concomitant ciclosporin
Pregnancy and lactation, and women of childbearing potential not using appropriate contraceptive measures
The 40 mg dose is additionally contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis (moderate renal impairment CrCl < 60 ml/min, hypothyroidism, personal or family history of hereditary muscular disorders, previous muscular toxicity with another statin or fibrate, alcohol abuse, situations where plasma levels may increase, Asian patients, concomitant fibrates)

Side effects

Headache (common)
Myalgia (common)
Constipation, nausea, abdominal pain (common)
Dizziness (common)
Asthenia (common)
Myopathy (including myositis) and, rarely, rhabdomyolysis; proteinuria and haematuria have also been observed

Interactions

Ciclosporin — concomitant use is contraindicated (§4.3)
Certain protease inhibitors, including combinations of ritonavir with atazanavir, lopinavir and/or tipranavir — increased rosuvastatin plasma concentration and increased risk of myopathy/rhabdomyolysis; consider alternatives or temporary discontinuation of rosuvastatin (§4.2, §4.4)
Fibrates — concomitant use is a predisposing factor for myopathy/rhabdomyolysis and contraindicates the 40 mg dose (§4.3)
Ezetimibe — very rare cases of rhabdomyolysis reported with ezetimibe combined with HMG-CoA reductase inhibitors; a pharmacodynamic interaction cannot be excluded and caution should be exercised with combined use (§4.4)
Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP); medicines interacting with these transporters may increase its plasma concentration (§4.2). Note: eMC §4.5 was not captured in the fetched source bundle; the full interactions section must be checked on the SPC.

Clinical monograph

How it works

It competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. The resulting upregulation of hepatic LDL receptors increases clearance of circulating LDL-cholesterol.

Prescribing in practice

Muscle toxicity (myopathy and rarely rhabdomyolysis) can occur — investigate unexplained muscle pain, tenderness or weakness and check creatine kinase; risk rises with higher doses, renal impairment, hypothyroidism and certain interacting drugs.
Use lower doses and apply a maximum-dose cap in patients of South or East Asian origin, in whom plasma exposure is higher.
Transaminases may rise and new-onset diabetes can occur; avoid in active liver disease, in pregnancy and breastfeeding, and review interacting drugs (e.g. ciclosporin, certain antivirals, gemfibrozil).

Monitoring

Check a lipid profile and baseline liver function before starting, with liver function rechecked during the early months of treatment; assess the lipid response and reinforce adherence. Measure creatine kinase if muscle symptoms develop, and check renal function and HbA1c/glucose where clinically indicated.

Counselling the patient

Report promptly any unexplained muscle pain, tenderness, cramps or weakness, particularly if accompanied by feeling unwell or fever.
Tell us if you become pregnant, are planning pregnancy or are breastfeeding, as this medicine should be stopped.
Take it regularly as prescribed and continue lifestyle measures; avoid large quantities of grapefruit juice and check before starting new medicines.

Evidence & guidelines

Statins are guideline-recommended for cardiovascular risk reduction (NICE NG238; NICE CG181 lipid modification).

Reference: NICE NG185; JUPITER Trial (NEJM 2008); 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).

Curated clinical cross-links plus same-class fallbacks.

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