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Rosuvastatin + Ezetimibe

Fixed-dose combination: statin plus intestinal cholesterol absorption inhibitor

ATC code: C10BA06(Rosuvastatin and ezetimibe)

Updated · Methodology

Indications

A

Dyslipidemia

Second line

Primary hypercholesterolemia and mixed dyslipidemia when -C goal is not met on the maximum tolerated rosuvastatin dose. Per 2019 and SEA 2023 – second-line. Dose: 5/10, 10/10, 20/10, 40/10 mg once daily anytime (rosuvastatin T½ 19 h). Full effect at 4 weeks. More effective than atorvastatin for the aggressive <55 mg/dL LDL-C goal.

Sources

  1. AEMPS: Ficha técnica de Rosuvastatina (2024)
  2. ESC/EAS: 2019 ESC/EAS Guidelines for the management of dyslipidaemias (2019)

ICD-10: E78 · ICD-11: 5C80

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

Rosuvastatin blocks HMG-CoA reductase with the highest potency among statins: 10 mg rosuvastatin ≈ 20 mg atorvastatin ≈ 40 mg simvastatin for -C reduction. Ezetimibe blocks the intestinal NPC1L1 protein, cutting cholesterol absorption. Combined LDL-C reduction reaches 50–70%. Minimal CYP metabolism – fewer drug interactions than atorvastatin.

Safety

Contraindications

  • Hypersensitivity
  • Active liver disease
  • Pregnancy and breastfeeding
  • Severe renal impairment (CrCl <30) for the 40 mg dose
  • Concomitant cyclosporine

Serious adverse effects

  • Rhabdomyolysis
  • Acute liver injury
  • Immune-mediated necrotizing myopathy
  • Interstitial pneumonitis (rare)

Common adverse effects

  • Myalgia
  • Arthralgia
  • GI upset
  • Transaminase elevation
  • Tubular proteinuria (reversible)

Pregnancy: can you take Rosuvastatin + Ezetimibe?

Contraindicated. Effective contraception in women of reproductive age; discontinue 1–2 months before planned conception.

Breastfeeding: can you take Rosuvastatin + Ezetimibe?

Contraindicated. Defer therapy until breastfeeding ends or use colestyramine only.

Calculate RID

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

Practical notes

Monitoring

Baseline ALT/AST, CK only on muscle symptoms. Start with 5 mg rosuvastatin in patients of Asian descent: longer T½ and higher myopathy risk at high doses.

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Frequently asked

What is Rosuvastatin + Ezetimibe used for?

Rosuvastatin + Ezetimibe is evaluated for the following indications with varying evidence strength: Dyslipidemia (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Rosuvastatin + Ezetimibe?

Common side effects of Rosuvastatin + Ezetimibe (≥ 1 in 100): Myalgia, Arthralgia, GI upset, Transaminase elevation, Tubular proteinuria (reversible). See the Safety section for uncommon and serious reactions.

Is Rosuvastatin + Ezetimibe safe during pregnancy?

Contraindicated. Effective contraception in women of reproductive age; discontinue 1–2 months before planned conception.

Is Rosuvastatin + Ezetimibe compatible with breastfeeding?

Contraindicated. Defer therapy until breastfeeding ends or use colestyramine only.

Who should not take Rosuvastatin + Ezetimibe?

Rosuvastatin + Ezetimibe is contraindicated in: Hypersensitivity; Active liver disease; Pregnancy and breastfeeding; Severe renal impairment (CrCl <30) for the 40 mg dose; Concomitant cyclosporine. Full list in the Safety section.

Other drugs in this group

Simvastatin, Simvastatin + Ezetimibe, Atorvastatin, Atorvastatin + Ezetimibe, Ezetimibe, Krill oil, Pitavastatin, Cod liver oil