Rosuvastatin

HMG-CoA reductase inhibitors (statins)

ATC code: C10AA07

Updated 24 Sep 2026 · Methodology

Indications

Dyslipidemia, primary CV prevention

First line

Prescribed according to cardiovascular risk stratification, same as atorvastatin. Rosuvastatin's advantage is greater reduction at lower doses: 5–10 mg of rosuvastatin is equivalent to 20–40 mg of atorvastatin. Convenient when potent lipid lowering is needed at a minimal dose.

Sources

N Engl J Med: Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease. (2016)
ESC/EAS: 2019 ESC/EAS Guidelines for the management of dyslipidaemias (2019)
JAMA: Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement. (2022)
Lancet: Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. (2010)
N Engl J Med: Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. (2008)
Am J Cardiol: Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). (2003)

ICD-10: E78.5 · ICD-11: 5C80

Established ASCVD, secondary prevention

First line

High-intensity statin (rosuvastatin 20–40 mg daily) for secondary prevention in established ASCVD. 2019 target: reduction over 50% from baseline and below 1.4 mmol/L. The JUPITER trial showed a 44% reduction in cardiovascular events in patients with elevated CRP. Interchangeable with atorvastatin in the high-intensity regimen.

Sources

ICD-10: I25 · ICD-11: BA5Z

Familial hypercholesterolemia

First line

Familial hypercholesterolemia requires high-intensity statins. Rosuvastatin 20–40 mg provides the greatest reduction among oral statins. If insufficient, ezetimibe is added, followed by PCSK9 inhibitors.

Sources

ICD-10: E78.0 · ICD-11: 5C80.00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Anti-aging and longevity

Not recommended

Rosuvastatin is a high-potency statin. It is prescribed for hyperlipidemia and for primary/secondary CV prevention in high-risk patients ( 2019, 2018; the JUPITER 2008 trial showed benefit at below 130 mg/dL with elevated hsCRP). In biohacker and longevity communities, rosuvastatin is actively promoted as a life-extension drug and a suppressor of chronic inflammation of aging. In people with normal lipid profile and low CV risk, clinical studies do not justify prophylactic use: the Ridker 2012 meta-analysis showed that JUPITER's benefit is limited to patients with specific risk markers. The drug causes myalgia, elevated transaminases, risk of rhabdomyolysis, elevated glucose, and new-onset diabetes risk. If rosuvastatin was prescribed at normal lipid levels, consider seeking a second opinion.

Sources

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Competitive HMG-CoA reductase inhibitor, like atorvastatin. Key differences: more potent lowering per milligram – reduces LDL by 45–55% at the maximum dose. Hydrophilic, with minimal CYP3A4 metabolism – resulting in fewer drug interactions with macrolides, azoles, and grapefruit.

Safety

Contraindications

Active liver disease or unexplained persistent transaminase elevation
Severe renal impairment (CrCl below 30 mL/min) for the 40 mg dose
Hypersensitivity to rosuvastatin or any component

Serious adverse effects

Rhabdomyolysis (rare, under 0.1%)
Immune-mediated necrotizing myopathy (very rare)
Proteinuria and hematuria at 40 mg dose (dose-dependent, usually transient)

Common adverse effects

Myalgia without CK elevation
Headache
Dyspepsia, nausea
Arthralgia
Transient transaminase elevation

Pregnancy: can you take Rosuvastatin?

AEMPS summary of product characteristics (section 4.6): rosuvastatin is contraindicated in pregnancy, and women of childbearing potential should use appropriate contraception. Because cholesterol and other products of cholesterol biosynthesis are essential for fetal development, the potential risk of HMG-CoA reductase inhibition outweighs the benefit of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity. If a patient becomes pregnant during treatment, rosuvastatin is stopped immediately.

Breastfeeding: can you take Rosuvastatin?

Systemic safety data during lactation are limited. The manufacturer and most international sources recommend avoidance. In patients with a statin indication, options include a temporary switch to formula feeding or deferring therapy until breastfeeding is complete.

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

May be taken at any time of day, with or without food. Half-life is about 19 hours, so evening dosing is not mandatory. The key is consistent daily timing.

Special situations

The key practical difference from atorvastatin is that rosuvastatin has minimal CYP3A4 interactions. Grapefruit, macrolides, and azole antifungals do not affect its levels. This simplifies regimens for patients on multiple drugs. Caution is needed with cyclosporine and gemfibrozil, which increase rosuvastatin levels via other mechanisms.

Drug–drug interactions

8 pairs found. Sorted from critical to minor.

CriticalCiclosporinImmunosuppressants. Calcineurin inhibitors

Mechanism

Cyclosporine inhibits OATP1B1 – rosuvastatin hepatic uptake falls, plasma concentration rises 7-fold. Crestor Section 7 contraindication.

Symptoms

Myalgia, weakness, dark urine, rising CK within 5-10 days.

Management

Combination contraindicated. Alternative – pravastatin 20 mg (minimal risk).

Sources

Pair details →Ciclosporin →

MajorClarithromycinMacrolide antibiotic

Mechanism

Cytochrome P450 enzymes play almost no part in breaking down rosuvastatin, so the rosuvastatin SmPC does not expect interactions through these enzymes. The documents contain no study of rosuvastatin with clarithromycin. The rosuvastatin SmPC lists macrolide antibiotics among drugs that increased the incidence of myositis and myopathy with other statins, and the clarithromycin SmPC reports rhabdomyolysis in patients taking clarithromycin with statins.

Symptoms

Unexplained muscle pain, weakness or cramps, especially with malaise or fever, and raised creatine kinase on blood tests (rosuvastatin SmPC). In rhabdomyolysis the urine turns dark and kidney function can suffer.

Management

The clarithromycin SmPC asks for caution when clarithromycin is combined with any statin and for monitoring for signs of myopathy. If the combination cannot be avoided, the statin is prescribed at the lowest registered dose (clarithromycin SmPC), which for rosuvastatin is 5 mg. The same SmPC suggests considering a statin that does not depend on CYP3A4, such as fluvastatin. Ask the patient to report unexplained muscle pain, weakness or cramps promptly. Check creatine kinase if they occur; stop rosuvastatin if it is more than 5 times the upper limit of normal or if muscle symptoms are severe and cause daily discomfort (rosuvastatin SmPC).

Sources

Pair details →Clarithromycin →

MajorColchicineAntigout agents

Mechanism

Additive myopathy and rhabdomyolysis risk. Rosuvastatin suppresses muscle ubiquinone synthesis; colchicine disrupts microtubule function in myocytes. Severe muscle toxicity has been reported, especially in older patients and chronic kidney disease.

Symptoms

Pain and weakness in large muscle groups (thighs, shoulders, calves), dark urine, elevated creatine kinase. Severe cases progress to rhabdomyolysis with acute kidney injury. Symptoms appear within 1–4 weeks of co-administration.

Management

Avoid prolonged combination. For acute gout, a short colchicine course (3–5 days) at 0.3 mg every other day is acceptable with muscle symptom and creatine kinase monitoring. Alternative: intra-articular or short systemic glucocorticoid.

Sources

FDA: Colchicine tablet (Par Health USA, LLC) – Prescribing Information (2012)

Pair details →Colchicine →

MajorGemfibrozilLipid-lowering agent of the fibrate class

Mechanism

Rosuvastatin is an OATP1B1 substrate and gemfibrozil blocks that transporter. Statin exposure rises, and with it the risk of myopathy and rhabdomyolysis, as with other HMG-CoA reductase inhibitors.

Symptoms

Muscle pain and weakness, muscle tenderness, darkening urine, rising creatine kinase. Rhabdomyolysis brings acute renal failure with it.

Management

Spanish SmPCs for gemfibrozil and rosuvastatin contraindicate gemfibrozil with rosuvastatin 40 mg. At lower doses the combination is not recommended either: the gemfibrozil SmPC requires avoiding gemfibrozil with any statin and allows only low rosuvastatin doses when the benefit outweighs the risk, and the rosuvastatin SmPC does not recommend the combination. If it cannot be avoided, rosuvastatin is started at 5 mg once daily (rosuvastatin SmPC). The US Food and Drug Administration () labels of both drugs cap rosuvastatin at 10 mg once daily. Ask the patient to report unexplained muscle pain, weakness or cramps promptly. Check creatine kinase if they occur, and stop treatment if it is more than 5 times the upper limit of normal (gemfibrozil and rosuvastatin SmPCs). Myopathy and rhabdomyolysis have occurred as early as 3 weeks and as late as several months into combined use, and routine creatine kinase checks do not guarantee that severe muscle and kidney damage will be prevented (gemfibrozil FDA label).

Sources

Pair details →Gemfibrozil →

MajorRitonavirHIV protease inhibitor / pharmacokinetic booster

Mechanism

Rosuvastatin barely uses CYP3A4 but is a substrate of OATP1B1 and BCRP transporters, both inhibited by ritonavir. Rosuvastatin plasma levels rise 2- to 4-fold.

Symptoms

Management

On ritonavir-boosted antiretroviral therapy, cap rosuvastatin at 10 mg/day. Check creatine kinase at 4–6 weeks and on muscle symptoms.

Sources

Pair details →Ritonavir →

ModerateAmiodaroneClass III antiarrhythmics (Vaughan Williams)

Mechanism

Rosuvastatin is minimally metabolised by CYP3A4, so amiodarone's CYP3A4 inhibition has limited effect. A slight AUC rise is possible via OATP1B1 transport. Additive myopathy risk is modest.

Symptoms

Muscle pain, weakness, dark urine. Rhabdomyolysis with rosuvastatin and amiodarone is rare.

Management

No dose adjustment needed. Cap rosuvastatin at 20 mg/day with amiodarone. Check CK if muscle pain develops. Alternative: pravastatin (minimal interaction).

Sources

FDA: Crestor (rosuvastatin) prescribing information (2010)

Pair details →Amiodarone →

ModerateAtorvastatinHMG-CoA reductase inhibitors (statins)

Mechanism

Dual statin therapy – doubling the same pharmacological class with additive myopathy risk and no therapeutic benefit.

Symptoms

Pain and weakness in large muscle groups (thighs, shoulders, calves), dark urine, elevated creatine kinase. Symptoms usually appear 2–6 weeks after starting the combination.

Management

The combination is not prescribed. Use one statin titrated to target. If LDL is not at goal on the maximum statin dose, add ezetimibe or a PCSK9 inhibitor, not a second statin.

Sources

FDA: Lipitor (atorvastatin) prescribing information (2017)

Pair details →Atorvastatin →

ModerateAzithromycinMacrolides

Mechanism

Rosuvastatin undergoes limited metabolism, about 10% of the dose, mainly by the CYP2C9 enzyme (rosuvastatin SmPC). Azithromycin is a weak inhibitor of cytochrome P450 enzymes (azithromycin SmPC). There are no data on higher rosuvastatin levels with this combination, but post-marketing cases of rhabdomyolysis have been reported in patients taking azithromycin with statins (azithromycin SmPC).

Symptoms

Muscle pain, weakness, cramps or tenderness, sometimes with malaise and fever. In rhabdomyolysis, urine turns dark from myoglobin and there is a risk of acute kidney injury (statin SmPCs).

Management

Use the combination with caution: post-marketing cases of rhabdomyolysis have been reported in patients taking azithromycin with statins (azithromycin SmPC). The documents do not require a change in the rosuvastatin dose. Ask the patient to report unexplained muscle pain, weakness or cramps at once, especially with malaise or fever. If these occur, measure creatine kinase (CK): stop rosuvastatin if CK is above 5 times the upper limit of normal or if muscle symptoms are severe (rosuvastatin SmPC).

Sources

Pair details →Azithromycin →

Label mentions43 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

CriticalCiclosporin
«en pacientes con tratamiento concomitante con ciclosporina.»
AEMPS, section 4.3 · Open on CIMA
MajorAtazanavir
«Interacciones que precisan ajustes posológicos de la rosuvastatina (ver también Tabla 1): Cuando sea necesario administrar rosuvastatina conjuntamente con otros medicamentos conocidos por aumentar la…»
AEMPS, section 4.5 · Open on CIMA
MajorGemfibrozil
«De acuerdo con los resultados de los estudios de interacción específica no se espera ninguna interacción farmacocinética significativa con el fenofibrato, sin embargo, sí podría darse una interacción…»
AEMPS, section 4.5 · Open on CIMA
MajorRitonavir
«Interacciones que precisan ajustes posológicos de la rosuvastatina (ver también Tabla 1): Cuando sea necesario administrar rosuvastatina conjuntamente con otros medicamentos conocidos por aumentar la…»
AEMPS, section 4.5 · Open on CIMA
Moderateantacidsclass named in the label
«Rosuvastatin Effects on Other Drugs: See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. (…»
FDA, section 7 · Open on DailyMed
Moderateanticoagulantesclass named in the label
«Antagonistas de la vitamina K: como con otros inhibidores de la HMG-CoA reductasa, el inicio del tratamiento o la escalada de la dosis con rosuvastatina en pacientes tratados de forma concomitante…»
AEMPS, section 4.5 · Open on CIMA
ModerateMagnesium hydroxide
«Rosuvastatin Effects on Other Drugs: See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. (…»
FDA, section 7 · Open on DailyMed
ModerateTicagrelor
«Ticagrelor: Ticagrelor puede causar insuficiencia renal y puede afectar la excreción renal de rosuvastatina, aumentando el riesgo de acumulación de rosuvastatina. En algunos casos, la…»
AEMPS, section 4.5 · Open on CIMA
ModerateWarfarin
«Antagonistas de la vitamina K: como con otros inhibidores de la HMG-CoA reductasa, el inicio del tratamiento o la escalada de la dosis con rosuvastatina en pacientes tratados de forma concomitante…»
AEMPS, section 4.5 · Open on CIMA
ModerateWarfarin
«Rosuvastatin Effects on Other Drugs: See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. (…»
FDA, section 7 · Open on DailyMed
antiácidosclass named in the label
«Antiácidos: la administración concomitante de rosuvastatina con una suspensión antiácida a base de hidróxido de aluminio y magnesio, originó una disminución de la concentración plasmática de la…»
AEMPS, section 4.5 · Open on CIMA
Clopidogrel
«Variación del AUC de rosuvastatina*: Clopidogrel 300 mg de carga, seguidos de 75 mg a las 24 horas»
AEMPS, section 4.5 · Open on CIMA
Darunavir
«Variación del AUC de rosuvastatina*: Darunavir 600 mg/ ritonavir 100 mg 2 veces al día, 7 días»
AEMPS, section 4.5 · Open on CIMA
Digoxin
«Digoxina : De acuerdo a los resultados de estudios específicos de interacción no se esperan interacciones importantes con la digoxina.»
AEMPS, section 4.5 · Open on CIMA
Dronedarone
«Variación del AUC de rosuvastatina*: Dronedarona 400 mg 2 veces al día»
AEMPS, section 4.5 · Open on CIMA
Eltrombopag
«Variación del AUC de rosuvastatina*: Eltrombopag 75 mg 1 vez al día, 5 días»
AEMPS, section 4.5 · Open on CIMA
Erythromycin
«Eritromicina: el uso concomitante de rosuvastatina y eritromicina originó una disminución del 20% del AUC y una disminución del 30% de la C max de la rosuvastatina. Esta interacción puede estar…»
AEMPS, section 4.5 · Open on CIMA
Ethinylestradiol
«Anticonceptivos orales/terapia hormonal sustitutiva (THS): la administración conjunta de rosuvastatina y un anticonceptivo oral originó un incremento del AUC de etinilestradiol y norgestrel del 26% y…»
AEMPS, section 4.5 · Open on CIMA
Ezetimibe
«Ezetimiba: el uso concomitante de rosuvastatina 10 mg con 10 mg de ezetimiba provocó un aumento de 1,2 veces en el AUC de rosuvastatina en sujetos hipercolesterolémicos (Tabla 1). Sin embargo, no se…»
AEMPS, section 4.5 · Open on CIMA
Fluconazole
«Enzimas del citocromo P450: los resultados de los estudios in vitro e in vivo muestran que la rosuvastatina no es ni un inhibidor ni un inductor de las isoenzimas del citocromo P450. Además, la…»
AEMPS, section 4.5 · Open on CIMA
Itraconazole
«Variación del AUC de rosuvastatina*: Itraconazol 200 mg 1 vez al día, 5 días»
AEMPS, section 4.5 · Open on CIMA
Ketoconazole
«Enzimas del citocromo P450: los resultados de los estudios in vitro e in vivo muestran que la rosuvastatina no es ni un inhibidor ni un inductor de las isoenzimas del citocromo P450. Además, la…»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

MajorAtazanavir
«Established and Other Potentially Significant Drug Interactions: atorvastatin, rosuvastatin ↑ atorvastatin ↑ rosuvastatin Titrate atorvastatin dose carefully and use the lowest necessary dose…»
FDA, section 7 · Open on DailyMed
MajorDarunavir
«Established and Other Potentially Significant Drug Interactions: Lipid Modifying Agents: HMG-CoA reductase inhibitors: lovastatin, simvastatin atorvastatin, pravastatin, rosuvastatin Other lipid…»
FDA, section 7 · Open on DailyMed
MajorGemfibrozil
«Uso concomitante de repaglinida, dasabuvir, selexipag (ver sección 4.5) simvastatina o rosuvastatina 40 mg (ver secciones 4.4 y 4.5).»
AEMPS, section 4.3 · Open on CIMA
MajorLeflunomide
«Dosis repetidas de A771726 aumentaron la C max media y AUC (2,65- y 2,51-veces, respectivamente) de rosuvastatina. Sin embargo, no hubo impacto aparente de este aumento de la exposición en plasma de…»
AEMPS, section 4.5 · Open on CIMA
MajorLeflunomide
«DRUG INTERACTIONS: Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo . For a patient taking leflunomide, the dose of rosuvastatin should not exceed 10 mg once daily. For other…»
FDA, section 7 · Open on DailyMed
MajorRitonavir
«Inhibidores de la HMG Co-reductasa: Los inhibidores de la HMG-Co-reductasa, como lovastatina y simvastatina, son altamente dependientes del metabolismo por CYP3A, se espera que presenten un marcado…»
AEMPS, section 4.5 · Open on CIMA
MajorRitonavir
«Established and Other Potentially Significant Drug Interactions: Lipid-modifying agents HMG-CoA Reductase Inhibitor: lovastatin simvastatin atorvastatin rosuvastatin ↑ lovastatin ↑ simvastatin ↑…»
FDA, section 7 · Open on DailyMed
MajorTicagrelor
«Simvastatin, Lovastatin, Rosuvastatin: Ticagrelor increases serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4. Avoid simvastatin and lovastatin doses…»
FDA, section 7 · Open on DailyMed
ModerateDarunavir
«INHIBIDORES DE LA HMG CO-A REDUCTASA: Cuando se requiera administrar de forma conjunta rosuvastatina con darunavir potenciado, se recomienda iniciar la administración con la dosis de rosuvastatina…»
AEMPS, section 4.5 · Open on CIMA
ModerateEltrombopag
«Inhibidores de la HMG CoA reductasa: La administración de 75 mg de eltrombopag una vez al día, durante 5 días, con una dosis única de 10 mg de rosuvastatina, sustrato de OATP1B1 y BCRP, a 39 sujetos…»
AEMPS, section 4.5 · Open on CIMA
ModerateEltrombopag
«Transporters: Use caution when concomitantly administering eltrombopag and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan…»
FDA, section 7 · Open on DailyMed
ModerateEslicarbazepine acetate
«Rosuvastatina: Hubo una reducción media del 36 - 39% en la exposición sistémica en voluntarios sanos cuando se coadministró con acetato de eslicarbazepina 1.200 mg una vez al día. El mecanismo de…»
AEMPS, section 4.5 · Open on CIMA
ModerateTicagrelor
«Rosuvastatina (sustrato de BCRP): Se ha demostrado que ticagrelor aumenta las concentraciones de rosuvastatina, lo que puede resultar en un mayor riesgo de miopatía, incluida la rabdomiólisis. Debe…»
AEMPS, section 4.5 · Open on CIMA
MinorVerapamil
«Fluvastatina, pravastatina y rosuvastatina no son metabolizadas por CYP3A4 y es menos probable que interactúen con verapamilo.»
AEMPS, section 4.5 · Open on CIMA
Ciclosporin
«Número de veces que cambia la exposición con ciclosporina: Rosuvastatina»
AEMPS, section 4.5 · Open on CIMA
Clopidogrel
«Rosuvastatina: se ha demostrado que clopidogrel aumenta la exposición a rosuvastatina en los pacientes en 2 veces (AUC) y 1,3 veces (Cmáx) tras la administración de una dosis de clopidogrel de 300…»
AEMPS, section 4.5 · Open on CIMA
Cobicistat
«Established and Other Potentially Significant Interactions: Other HMG-CoA reductase inhibitors: e.g., atorvastatin rosuvastatin ↑ HMG-CoA reductase inhibitors Coadministration of atazanavir and…»
FDA, section 7 · Open on DailyMed
Ezetimibe
«Estatinas: No se observaron interacciones farmacocinéticas clínicamente relevantes cuando ezetimiba se administró junto con atorvastatina, simvastatina, pravastatina, lovastatina, fluvastatina o…»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Rosuvastatin used for?

Rosuvastatin is evaluated for the following indications with varying evidence strength: Dyslipidemia, primary CV prevention (evidence tier A), Established ASCVD, secondary prevention (evidence tier A), Familial hypercholesterolemia (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Rosuvastatin?

Common side effects of Rosuvastatin (≥ 1 in 100): Myalgia without CK elevation, Headache, Dyspepsia, nausea, Arthralgia, Transient transaminase elevation. See the Safety section for uncommon and serious reactions.

Is Rosuvastatin safe during pregnancy?

Is Rosuvastatin compatible with breastfeeding?

Who should not take Rosuvastatin?

Rosuvastatin is contraindicated in: Active liver disease or unexplained persistent transaminase elevation; Severe renal impairment (CrCl below 30 mL/min) for the 40 mg dose; Hypersensitivity to rosuvastatin or any component. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 03/19/2026
FDA / DailyMedLabel dated 06/12/2026

Other drugs in this group

Rosuvastatin + Ezetimibe, Simvastatin, Simvastatin + Ezetimibe, Atorvastatin, Cod liver oil, Gemfibrozil, Omega-3 triglycerides (EPA and DHA), Atorvastatin + Ezetimibe