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SafetyScorer

Is Rosuvastatin safe?

Rosuvastatin

Rosuvastatin (Crestor) is a strong, well-studied statin with no boxed warning and no dependence. Serious muscle injury is rare. The catch is dose: the 40 mg tablet carries more muscle risk, and people of Asian descent, people with severe kidney disease and those on certain drugs need lower caps.

High confidence#5 of 65 medicationsUpdated
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Brands
Crestor; generic rosuvastatin worldwide
Adult dose range
5 mg to 40 mg once a day (US label, 2026)
Asian patients
Start at 5 mg; about 2 times the blood levels
Boxed warning
None
Controlled substance
No
US prescriptions
About 53.7 million in 2024, 9th most prescribed (ClinCalc)
On the market
US since August 2003

How the score breaks down

The overall score is the weighted average of these factors. Scoring rules

  • Serious side effects30% of score

    84 out of 100, Good

    Rhabdomyolysis is rare but more likely at 40 mg, over 65, with kidney disease or interacting drugs. In JUPITER, diabetes was reported in 2.8% vs 2.3% on placebo; in LODESTAR it needed treatment in 7.2% vs 5.3% on atorvastatin.

  • Overdose margin20% of score

    92 out of 100, Excellent

    Serious poisoning from rosuvastatin alone is very unusual. The label lists no antidote and says haemodialysis does not clear it, but overdoses rarely cause lasting harm.

  • Interactions15% of score

    72 out of 100, Good

    Fewer than atorvastatin because it is not broken down by CYP450 enzymesA family of liver enzymes that break down many medicines. When another drug or supplement speeds them up or slows them down, drug levels change.More in the glossary, so grapefruit is not an issue. Cyclosporine raises exposure about 7-fold (cap 5 mg); gemfibrozil and some hepatitis C drugs should be avoided; it can raise INR on warfarin.

  • Dependence and misuse15% of score

    98 out of 100, Excellent

    No dependence, misuse or withdrawal. Not a Controlled substanceA medicine or drug that the law restricts because it can be misused or cause dependence. Countries group them into schedules or classes.More in the glossary.

  • Regulatory warnings10% of score

    85 out of 100, Excellent

    No Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary. In 2004 and 2005 the FDA and Health Canada issued advisories on dosing after muscle and kidney reports and a study showing about twice the levels in Asian patients, which led to the 5 mg starting dose.

  • Track record10% of score

    93 out of 100, Excellent

    Approved in the US in August 2003 and one of the ten most prescribed US drugs in 2024. Large outcome trials include JUPITER (17,802 people) and LODESTAR (4,400).

Is rosuvastatin safe?

Yes, for most people who need it. Rosuvastatin, sold as Crestor, was the ninth most prescribed medicine in the United States in 2024, with about 53.7 million prescriptions for 14.4 million people (ClinCalc). It has no Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary, no dependence and little danger in overdose. We score it 87, the same as atorvastatin.

The main catch is that rosuvastatin is potent, and its muscle risk climbs with dose. The label sets lower ceilings for three groups: people of Asian descent, people with severe kidney disease, and people taking certain other drugs. If you are in one of these groups, the dose on your box matters more than usual.

Muscle problems and the 40 mg dose

All statins can cause myopathy (muscle pain or weakness with raised CK, a muscle enzyme in the blood) and, rarely, rhabdomyolysis, in which damaged muscle releases proteins that can injure the kidneys. The 2026 US label says the myopathy risk is greater at 40 mg a day than at lower doses. Other risk factors it lists are age 65 or over, an underactive thyroid that is not controlled, kidney problems and some other cholesterol drugs.

In everyday terms, most aches in people on statins are not caused by the drug. In the JUPITER trial of 17,802 people, muscle aches were reported by 7.6% on rosuvastatin 20 mg and 6.6% on placebo. Unexplained muscle pain, tenderness or weakness, especially with fever, tiredness or dark urine, needs a doctor promptly.

Rosuvastatin has one quirk of its own. At 40 mg, trial patients more often had protein or traces of blood on urine dipstick tests. The label says this was generally temporary and did not come with worse kidney function.

Why Asian patients get a lower dose

In 2005, after a study found roughly twice the blood levels in Asian Americans compared with white volunteers, the FDA and Health Canada changed the advice. Health Canada's notice of 3 March 2005 named people of Filipino, Chinese, Japanese, Korean, Vietnamese or South Asian origin. The current US label still says to start Asian patients at 5 mg once a day and to weigh risks and benefits before going above 20 mg.

This came at the end of a rough start for the drug. Reports of muscle and kidney problems in 2003 and 2004 led to FDA advisories urging doctors to follow the label and to avoid 40 mg as a starting dose. Two decades later, with tens of millions of users, rosuvastatin's safety record at the recommended doses looks similar to other statins.

Rosuvastatin vs atorvastatin

The two are the most prescribed high-intensity statins, and the differences are small but real.

RosuvastatinAtorvastatin
Usual adult range5 to 40 mg once a day10 to 80 mg once a day
Broken down by CYP450 enzymesA family of liver enzymes that break down many medicines. When another drug or supplement speeds them up or slows them down, drug levels change.More in the glossaryNoYes
Grapefruit warning on US labelNoYes, over 1.2 litres a day
Lower cap for Asian patientsYesNo
New diabetes needing treatment (LODESTAR)7.2%5.3%
Cataract surgery (LODESTAR)2.5%1.5%

LODESTAR, published in the BMJ in 2023, randomised 4,400 Korean adults with coronary artery disease to one drug or the other for three years. Deaths, heart attacks, strokes and procedures were about equal (8.7% vs 8.2%). Rosuvastatin lowered LDL cholesterol a little more but came with more new diabetes and more cataract surgery. This was one open-label trial in one country, so it is a reason for discussion with your doctor rather than a reason to switch on your own.

Interactions to check

Because rosuvastatin does not rely on CYP450 enzymesA family of liver enzymes that break down many medicines. When another drug or supplement speeds them up or slows them down, drug levels change.More in the glossary, the common antibiotic and antifungal clashes that affect atorvastatin and simvastatin mostly do not apply. The drugs that matter work through other routes:

  • Cyclosporine: raises rosuvastatin exposure about 7-fold. Maximum 5 mg a day.
  • Gemfibrozil: avoid; if it cannot be avoided, start at 5 mg and do not exceed 10 mg.
  • Some hepatitis C and HIV drugs: sofosbuvir/velpatasvir/voxilaprevir and ledipasvir/sofosbuvir should be avoided; several others cap the dose at 10 mg.
  • Darolutamide, belumosudil: maximum 5 mg. Ticagrelor, febuxostat and fostamatinib: maximum 20 mg.
  • Warfarin: rosuvastatin can raise INR, so the label asks for INR checks when starting, changing or stopping it.
  • Antacids with aluminium and magnesium hydroxide: take rosuvastatin at least 2 hours before.

Red yeast rice contains a natural statin, so taking it on top of rosuvastatin doubles up on the same effect; see our red yeast rice page.

Who should be careful

  • People of Asian descent, who should usually start at 5 mg.
  • People with severe kidney disease not on dialysis: the label says start at 5 mg and do not exceed 10 mg.
  • Anyone on cyclosporine, gemfibrozil, hepatitis C or HIV treatment, or warfarin.
  • People with acute liver failure or decompensated cirrhosis, in whom it is ContraindicationA situation in which a medicine should not be used, because the risk clearly outweighs any benefit, such as a known allergy to it.More in the glossary.
  • Anyone pregnant, breastfeeding or planning a pregnancy.

If side effects bother you, talk to your doctor or pharmacist before stopping. Lower doses, alternate-day dosing or another statin are options a doctor can weigh.

How we scored it

Dependence (98), Overdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (92) and track record (93) are strong. Interactions (72) scores better than atorvastatin because grapefruit and the common CYP450 enzymesA family of liver enzymes that break down many medicines. When another drug or supplement speeds them up or slows them down, drug levels change.More in the glossary drugs are not a problem, while serious side effects (84) and regulatory warnings (85) reflect the dose-related muscle risk, the diabetes signal and the 2004 to 2005 advisories.

Questions people ask

Is rosuvastatin stronger than atorvastatin?

Milligram for milligram, yes. In the LODESTAR trial, people on an average of 17 mg rosuvastatin reached slightly lower LDL cholesterol than people on an average of 36 mg atorvastatin, and heart attacks, strokes and deaths were about the same in both groups. Stronger does not mean better for everyone; your doctor picks the drug and dose for your risk.

Can I drink grapefruit juice with rosuvastatin?

The Crestor label has no grapefruit warning, because rosuvastatin is not broken down by the liver enzyme that grapefruit blocks. That is one practical difference from atorvastatin and simvastatin. Ask your pharmacist if you take other medicines that do interact with grapefruit.

Why do Asian patients start on a lower dose of rosuvastatin?

Studies found that people of East and South Asian descent have about twice the blood levels of rosuvastatin at the same dose. Since 2005 the label has recommended starting at 5 mg and weighing the risks carefully before going above 20 mg.

Does rosuvastatin cause diabetes?

It can raise blood sugar slightly. In the JUPITER trial, diabetes was reported in 2.8% on rosuvastatin and 2.3% on placebo, and in a Korean trial it was a little more common than with atorvastatin. For people with heart disease or high risk, the reduction in heart attacks and strokes is usually larger; talk to your doctor about your own balance.

What should I do if I miss a dose of rosuvastatin?

The label says not to take an extra dose. Skip the missed one and take the next dose at the usual time.

Sources

  1. 1.CRESTOR (rosuvastatin) tablets label (opens in a new tab) · DailyMed / AstraZeneca, 2026
  2. 2.Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease (LODESTAR) (opens in a new tab) · BMJ, 2023
  3. 3.Health Canada advises patients about risks of CRESTOR (rosuvastatin) (opens in a new tab) · Health Canada, 2005
  4. 4.Rosuvastatin drug usage statistics, United States, 2014 - 2024 (opens in a new tab) · ClinCalc DrugStats, 2026
  5. 5.Rosuvastatin (opens in a new tab) · NHS, 2025
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