Rosuvastatin Accord
Rosuvastatin (as rosuvastatin calcium) – HMG-CoA Reductase Inhibitor (Statin)
Rosuvastatin Accord is a prescription statin medication used to lower high cholesterol and reduce the risk of heart attack, stroke, and other cardiovascular events. It contains the active ingredient rosuvastatin calcium, which works by blocking the enzyme HMG-CoA reductase in the liver, thereby reducing LDL ("bad") cholesterol production while increasing HDL ("good") cholesterol levels. This comprehensive guide covers dosage, side effects, drug interactions, and important safety information.
Quick Facts
Key Takeaways
- Rosuvastatin Accord is one of the most potent statins available, capable of reducing LDL cholesterol by up to 63% at the highest dose.
- Treatment should be combined with lifestyle changes including a cholesterol-lowering diet and regular exercise for optimal results.
- The most common side effects are muscle pain, headache, and gastrointestinal symptoms; serious muscle damage (rhabdomyolysis) is rare but requires immediate medical attention.
- This medication must not be taken during pregnancy or breastfeeding, and effective contraception is essential for women of childbearing age.
- Multiple drug interactions exist, particularly with cyclosporine, certain HIV and hepatitis C treatments, and fibrates – always inform your doctor of all medications you take.
What Is Rosuvastatin Accord and What Is It Used For?
Rosuvastatin Accord belongs to a class of medicines known as statins (HMG-CoA reductase inhibitors). These medications are the cornerstone of cholesterol-lowering therapy worldwide, recommended by major international guidelines including the European Society of Cardiology (ESC), the American Heart Association (AHA), and the National Institute for Health and Care Excellence (NICE).
The medication is prescribed when you have been diagnosed with high cholesterol (hypercholesterolaemia), meaning you have an increased risk of developing cardiovascular disease. High cholesterol is a major risk factor for atherosclerosis – a condition where fatty deposits (plaques) accumulate on the walls of your arteries, gradually narrowing them. If left untreated, these plaques can rupture and form blood clots, potentially leading to a heart attack or stroke.
Rosuvastatin works by selectively and competitively inhibiting HMG-CoA reductase, the rate-limiting enzyme in the mevalonate pathway responsible for cholesterol synthesis in the liver. By reducing the liver's own cholesterol production, the liver compensates by increasing the number of LDL receptors on its surface, which removes more LDL cholesterol from the bloodstream. Clinical trials have demonstrated that rosuvastatin can reduce LDL cholesterol by 45–63% depending on the dose, making it one of the most effective statins available.
Beyond lowering LDL ("bad") cholesterol, rosuvastatin also increases HDL ("good") cholesterol by 8–14% and reduces triglycerides by 10–35%. This comprehensive improvement in the lipid profile provides significant cardiovascular protection. The landmark JUPITER trial demonstrated that rosuvastatin reduced the risk of major cardiovascular events by 44% in apparently healthy individuals with elevated C-reactive protein levels.
Why Is It Important to Continue Taking Rosuvastatin Accord?
For most people, high cholesterol produces no noticeable symptoms. This often leads patients to believe they no longer need treatment once their cholesterol levels normalise. However, stopping the medication typically causes cholesterol levels to rise again within weeks, potentially accelerating the atherosclerotic process. You should continue taking Rosuvastatin Accord even after achieving target cholesterol levels, unless your prescribing physician advises otherwise.
Rosuvastatin Accord may also be prescribed for primary cardiovascular prevention – reducing the risk of heart attack, stroke, and arterial revascularisation procedures in patients who do not yet have diagnosed cardiovascular disease but carry significant risk factors such as age, hypertension, low HDL cholesterol, smoking, or a family history of premature coronary heart disease.
What Should You Know Before Taking Rosuvastatin Accord?
Contraindications
You must not take Rosuvastatin Accord if any of the following apply to you:
- You have had an allergic reaction to rosuvastatin or any of the other ingredients in this medicine (listed in the Ingredients section below).
- You are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Accord, stop immediately and contact your doctor. Women should use effective contraception during treatment.
- You have active liver disease or unexplained, persistent elevations of serum transaminases (liver enzymes).
- You have severe kidney impairment (creatinine clearance <30 mL/min).
- You have unexplained, repeated muscle pain or tenderness (myopathy).
- You are taking cyclosporine (used after organ transplantation and in certain autoimmune conditions).
- You are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C).
The highest dose (40 mg) must not be used if you have moderate kidney problems, thyroid disorders, a personal or family history of muscle disease, previous muscle problems with other statins, regular heavy alcohol consumption, are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian), or are taking fibrates.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Rosuvastatin Accord if any of the following apply to you:
- You have kidney problems of any degree – dose adjustments may be necessary.
- You have liver problems – your doctor will perform liver function tests before and during treatment.
- You have a history of muscle problems or a family history of hereditary muscular disorders. Tell your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.
- You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatin or related medications.
- You regularly consume large amounts of alcohol.
- You have thyroid problems (hypothyroidism).
- You are taking fibrates (another type of cholesterol-lowering medication).
- You are taking HIV medications such as ritonavir with lopinavir and/or atazanavir.
- You are taking or have recently taken fusidic acid (an antibiotic) within the last 7 days. The combination of fusidic acid and rosuvastatin can lead to serious muscle problems (rhabdomyolysis).
- You are over 70 years of age – your doctor may need to select a lower starting dose.
- You are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian) – pharmacokinetic differences may necessitate a lower starting dose.
- You suffer from severe respiratory insufficiency.
- You have or have had myasthenia gravis or ocular myasthenia – statins may occasionally worsen these conditions.
Serious skin reactions including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with rosuvastatin treatment. Stop taking Rosuvastatin Accord and seek immediate medical attention if you develop widespread rash, high body temperature, enlarged lymph nodes, or reddish target-shaped or circular patches on the body with blistering.
During treatment, your doctor will monitor you if you have diabetes or are at risk of developing diabetes. You are more likely at risk if you have high blood sugar and blood fat levels, are overweight, or have high blood pressure. Statin-associated diabetes is a recognised effect; however, cardiovascular benefits generally outweigh this risk for most patients.
Pregnancy and Breastfeeding
Rosuvastatin Accord is absolutely contraindicated during pregnancy and breastfeeding. Cholesterol and its biosynthetic products are essential for normal foetal development, and inhibition of HMG-CoA reductase may cause foetal harm. If you become pregnant while taking this medication, discontinue it immediately and consult your doctor. Women of childbearing potential must use reliable contraception throughout treatment.
Children and Adolescents
Rosuvastatin Accord should not be given to children under 6 years of age. In children and adolescents aged 6–17 years with familial hypercholesterolaemia, the usual dose range is 5–20 mg once daily, with a maximum of 10 mg or 20 mg depending on the underlying condition. The 40 mg tablet is not suitable for patients under 18 years.
Driving and Operating Machinery
Rosuvastatin Accord does not significantly affect driving ability or the ability to operate machinery in most patients. However, some individuals may experience dizziness as a side effect. If you feel dizzy, consult your doctor before driving or operating heavy machinery.
How Does Rosuvastatin Accord Interact with Other Drugs?
Drug interactions can alter the way Rosuvastatin Accord works or increase the risk of serious side effects. Some medications increase the blood levels of rosuvastatin, raising the risk of myopathy and rhabdomyolysis. Others may have their own effectiveness altered by rosuvastatin. The following table summarises the most important interactions.
Major Interactions
| Interacting Drug | Category | Clinical Significance | Action Required |
|---|---|---|---|
| Cyclosporine | Immunosuppressant | Increases rosuvastatin levels ~7-fold | Contraindicated – do not use together |
| Sofosbuvir/Velpatasvir/Voxilaprevir | Hepatitis C antiviral | Significantly increases rosuvastatin exposure | Contraindicated – do not use together |
| Gemfibrozil | Fibrate | Increases rosuvastatin levels ~2-fold; increased myopathy risk | Limit rosuvastatin to max 20 mg; avoid 40 mg |
| Lopinavir/Ritonavir | HIV antiviral | Increases rosuvastatin levels ~2-fold | Dose adjustment required; consult specialist |
| Atazanavir | HIV antiviral | Increases rosuvastatin levels ~3-fold | Dose adjustment required; consult specialist |
| Fusidic acid (oral) | Antibiotic | Risk of rhabdomyolysis | Suspend rosuvastatin during fusidic acid treatment |
Other Notable Interactions
| Interacting Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Warfarin / Clopidogrel / Ticagrelor | Anticoagulants/Antiplatelets | Rosuvastatin may increase INR with warfarin | Monitor INR closely when starting or changing dose |
| Ezetimibe | Cholesterol absorption inhibitor | May slightly increase rosuvastatin exposure | Use with caution; monitor for muscle symptoms |
| Fenofibrate | Fibrate | Increased risk of myopathy | Avoid 40 mg dose; monitor for muscle symptoms |
| Erythromycin | Antibiotic | May decrease rosuvastatin levels | Monitor cholesterol levels |
| Oral contraceptives | Hormonal | Rosuvastatin may increase ethinylestradiol and norgestrel levels | Consider when selecting oral contraceptive dose |
| Antacids (aluminium/magnesium) | GI medication | May decrease rosuvastatin absorption | Take antacid at least 2 hours after rosuvastatin |
| Regorafenib / Darolutamid / Capmatinib | Cancer treatments | May increase rosuvastatin levels | Inform your oncologist; dose adjustment may be needed |
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking Rosuvastatin Accord. Your doctor will advise you when it is safe to resume. Using rosuvastatin together with fusidic acid can, in rare cases, lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
What Is the Correct Dosage of Rosuvastatin Accord?
Always take Rosuvastatin Accord exactly as your doctor or pharmacist has told you. Do not change your dose without consulting your healthcare provider. The optimal dose depends on your cholesterol levels, cardiovascular risk profile, and individual factors that may affect how you respond to the medication.
Adults
Starting Dose
Treatment typically begins with 5 mg or 10 mg once daily, even if you were previously taking a higher dose of another statin. The choice of starting dose depends on your cholesterol levels, your cardiovascular risk, and whether you have factors that may make you more susceptible to side effects.
Lower Starting Dose (5 mg)
Your doctor may prescribe the lowest starting dose if you:
- Are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
- Are over 70 years of age
- Have moderate kidney impairment
- Are at increased risk for myopathy
Dose Titration
Your doctor may increase your dose at 4-week intervals until the target cholesterol level is achieved: 5 mg → 10 mg → 20 mg → 40 mg. The maximum recommended dose is 40 mg daily, reserved only for patients with high cholesterol levels at high cardiovascular risk whose levels are not adequately controlled with 20 mg.
Cardiovascular Prevention
For reducing the risk of heart attack, stroke, and other cardiovascular events: the recommended dose is 20 mg per day. Lower doses may be used if risk factors for side effects are present.
Children and Adolescents (6–17 Years)
Paediatric Dosing
The usual dose range is 5–20 mg once daily. Treatment starts at 5 mg daily, with gradual increases as needed. The maximum dose is 10 mg or 20 mg depending on the underlying condition. The 40 mg tablet should not be used in patients under 18 years. Rosuvastatin Accord should not be given to children under 6 years.
Elderly Patients (Over 70 Years)
A starting dose of 5 mg is recommended for patients over 70 years of age. The dose may be titrated upward based on response and tolerability, but caution is warranted due to age-related changes in drug metabolism and the higher prevalence of comorbidities.
How to Take This Medicine
Swallow each tablet whole with a glass of water. You may take Rosuvastatin Accord with or without food, at any time of day. Unlike some other statins, rosuvastatin does not need to be taken at bedtime to be effective. However, try to take it at the same time each day to maintain a consistent routine and improve adherence.
Attend regular follow-up appointments with your doctor for cholesterol monitoring to ensure your levels have reached and remain at the target range. Your doctor may adjust your dose based on these results.
Missed Dose
If you forget to take a dose, simply take your next dose at the usual scheduled time. Do not take a double dose to make up for a missed one. Missing an occasional dose is unlikely to significantly affect your cholesterol levels, but consistent daily use is important for optimal benefit.
Overdose
If you take more than the prescribed dose, or if a child accidentally ingests the medication, contact your doctor, nearest emergency department, or poison control centre immediately for advice. There is no specific antidote for rosuvastatin overdose; treatment is supportive and symptomatic. Take the medication packaging with you so healthcare professionals can identify what was taken.
Talk to your doctor before stopping Rosuvastatin Accord. If you stop taking it, your cholesterol levels are likely to rise again. Stopping statin therapy has been associated with increased cardiovascular risk, particularly in patients with established heart disease. Your doctor will help you weigh the benefits and risks of continued treatment.
What Are the Side Effects of Rosuvastatin Accord?
Like all medicines, Rosuvastatin Accord can cause side effects, although not everyone gets them. Most side effects are mild and tend to resolve on their own. However, it is important to be aware of serious side effects that require immediate medical attention.
- Difficulty breathing, with or without swelling of the face, lips, tongue, or throat
- Swelling of the face, lips, tongue, or throat causing difficulty swallowing
- Severe skin itching with raised bumps (hives)
- Reddish, target-shaped or circular patches with blistering, skin peeling, mouth/throat/genital sores (Stevens-Johnson syndrome)
- Widespread rash, high body temperature, enlarged lymph nodes (DRESS syndrome)
- Unexplained muscle pain, tenderness, or weakness, especially with fever or malaise
Common
May affect up to 1 in 10 people
- Headache
- Abdominal pain
- Constipation
- Nausea
- Muscle pain (myalgia)
- Weakness (asthenia)
- Dizziness
- Increased protein in urine (mainly with 40 mg dose)
- Diabetes mellitus (in patients with risk factors)
Uncommon
May affect up to 1 in 100 people
- Rash, itching, or other skin reactions
- Increased protein in urine (with 5 mg, 10 mg, and 20 mg doses)
Rare
May affect up to 1 in 1,000 people
- Severe abdominal pain (pancreatitis)
- Increased liver enzymes in blood
- Easy bruising or bleeding due to low platelet count (thrombocytopenia)
- Severe allergic reaction (angioedema) – swelling of face, lips, tongue, throat
- Muscle damage (rhabdomyolysis) in adults
- Lupus-like syndrome (skin rash, joint problems, effects on blood cells)
Very Rare
May affect up to 1 in 10,000 people
- Jaundice (yellowing of skin and eyes)
- Hepatitis (liver inflammation)
- Blood in urine (haematuria)
- Peripheral neuropathy (numbness or tingling in hands and feet)
- Joint pain (arthralgia)
- Memory loss
- Gynaecomastia (breast enlargement in men)
Frequency Not Known
Cannot be estimated from available data
- Diarrhoea
- Cough
- Shortness of breath
- Oedema (swelling)
- Sleep disturbances including insomnia and nightmares
- Sexual difficulties
- Depression
- Respiratory problems including persistent cough or fever
- Tendon disorders
- Persistent muscle weakness
- Myasthenia gravis (generalised muscle weakness)
- Ocular myasthenia (eye muscle weakness)
Muscle symptoms are more common in children and adolescents than in adults. As with all statins, a very small number of people have experienced distressing muscle effects, and in rare cases this has developed into a potentially life-threatening condition called rhabdomyolysis. If your child reports persistent muscle pain or weakness, contact their doctor promptly.
If you experience weakness in your arms or legs that worsens after periods of activity, double vision, drooping eyelids, difficulty swallowing, or shortness of breath, talk to your doctor. These may be signs of myasthenia gravis, a condition that statins can occasionally unmask or worsen.
How Should You Store Rosuvastatin Accord?
Proper storage of your medication ensures it remains effective throughout its shelf life. Follow these guidelines:
- Temperature: No special temperature requirements – store at room temperature.
- Packaging: Keep in the original packaging to protect from moisture and light.
- HDPE bottles: If your tablets are supplied in an HDPE bottle, use them within 3 months of first opening.
- Children: Store out of the sight and reach of children.
- Expiry date: Do not use after the expiry date printed on the carton, blister, or label (EXP). The expiry date refers to the last day of that month.
- Damaged packaging: Do not use if the packaging appears damaged or has been previously opened.
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused medicines to your pharmacy for safe disposal. This helps protect the environment.
What Does Rosuvastatin Accord Contain?
Active Ingredient
The active substance is rosuvastatin (as rosuvastatin calcium). Each film-coated tablet contains either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
Inactive Ingredients (Excipients)
Tablet core: Anhydrous lactose, microcrystalline cellulose (E460), light magnesium oxide, magnesium stearate (E470b), crospovidone type A (E1202).
Film coating:
- 5 mg: Hypromellose (E464), triacetin (E1518), titanium dioxide (E171), lactose monohydrate, yellow iron oxide (E172).
- 10 mg and 20 mg: Hypromellose (E464), triacetin (E1518), titanium dioxide (E171), lactose monohydrate, red iron oxide (E172), yellow iron oxide (E133), quinoline yellow aluminium lake (E104), brilliant blue FCF aluminium lake (E133).
- 40 mg: Hypromellose (E464), triacetin (E1518), titanium dioxide (E171), lactose monohydrate, sunset yellow FCF aluminium lake (E110), allura red AC aluminium lake (E129), brilliant blue FCF aluminium lake (E133).
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine. The 40 mg tablets also contain sunset yellow FCF (E110) and allura red AC (E129), which may cause allergic reactions in susceptible individuals.
Tablet Appearance
- 5 mg: Yellow, round, biconvex film-coated tablet, approximately 7.0 mm in diameter, marked "5" on one side and "R" on the other.
- 10 mg: Pink, round, biconvex film-coated tablet, approximately 7.0 mm in diameter, marked "10" on one side and "R" on the other.
- 20 mg: Pink, round, biconvex film-coated tablet, approximately 9.0 mm in diameter, marked "20" on one side and "R" on the other.
- 40 mg: Pink, oval, biconvex film-coated tablet, approximately 11.5 mm long and 6.9 mm wide, marked "40" on one side and "R" on the other.
Pack Sizes
Tablets are available in aluminium/aluminium blister packs and HDPE bottles. Common pack sizes include 7, 28, 30, 60, 84, 90, 98, or 100 tablets (blister) and 30 or 500 tablets (HDPE bottle). Not all pack sizes may be marketed in your country.
Frequently Asked Questions
Rosuvastatin Accord is prescribed to lower high cholesterol (hypercholesterolaemia) and to reduce the risk of cardiovascular events such as heart attack and stroke. It works by inhibiting HMG-CoA reductase, the liver enzyme responsible for producing cholesterol. It is used when diet and exercise alone are insufficient to achieve target cholesterol levels, or for primary prevention in patients with multiple cardiovascular risk factors.
The most common side effects (affecting up to 1 in 10 people) include headache, abdominal pain, constipation, nausea, muscle pain, weakness, and dizziness. These are generally mild and often resolve with continued use. If you experience unexplained, persistent muscle pain or weakness, especially with fever, contact your doctor immediately as this could indicate the rare but serious condition rhabdomyolysis.
No. Rosuvastatin Accord is strictly contraindicated during pregnancy and breastfeeding. Statins inhibit cholesterol synthesis, which is essential for normal foetal development. Women of childbearing age must use effective contraception while taking this medication. If you become pregnant, stop taking Rosuvastatin Accord immediately and consult your doctor.
The usual starting dose for adults is 5 mg or 10 mg once daily. Your doctor may gradually increase the dose every 4 weeks to 20 mg or, in selected high-risk patients, up to 40 mg daily. For children aged 6–17 years, the dose range is 5–20 mg. Tablets can be taken with or without food, at any time of day, but consistency in timing helps with adherence.
No. Unlike some shorter-acting statins (such as simvastatin), rosuvastatin has a long half-life of approximately 19 hours, which means it remains active in the body throughout the day regardless of when you take it. You can take Rosuvastatin Accord at any time that suits your routine. The key is consistency – taking it at the same time each day.
Rosuvastatin has clinically significant interactions with several medicines. It is contraindicated with cyclosporine and sofosbuvir/velpatasvir/voxilaprevir. Caution is required with HIV antivirals (ritonavir, lopinavir, atazanavir), fibrates (gemfibrozil, fenofibrate), oral fusidic acid, warfarin, and certain cancer medications. Always tell your doctor and pharmacist about all medicines, supplements, and herbal products you use.
References
- European Medicines Agency (EMA). Rosuvastatin – Summary of Product Characteristics (SmPC). EMA Product Database. Available at: www.ema.europa.eu. Accessed January 2026.
- Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. European Heart Journal. 2020;41(1):111–188. doi:10.1093/eurheartj/ehz455
- Ridker PM, Danielson E, Fonseca FAH, et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein (JUPITER trial). N Engl J Med. 2008;359:2195–2207. doi:10.1056/NEJMoa0807646
- National Institute for Health and Care Excellence (NICE). Cardiovascular disease: risk assessment and reduction, including lipid modification. Clinical guideline CG181. Updated 2023.
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. J Am Coll Cardiol. 2019;73(24):e285–e350.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list, 2023. Geneva: World Health Organization; 2023.
- British National Formulary (BNF). Rosuvastatin. NICE BNF. Available at: bnf.nice.org.uk. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). Rosuvastatin Calcium – Prescribing Information. Available at: www.accessdata.fda.gov. Accessed January 2026.
Editorial Team
Written by iMedic Medical Editorial Team – specialists in clinical pharmacology, cardiology, and internal medicine with extensive experience in evidence-based medical communication.
Reviewed by iMedic Medical Review Board – an independent panel of board-certified physicians who ensure all content meets international medical standards (ESC, EMA, FDA, WHO).
Evidence Standard: All medical claims in this article are supported by Level 1A evidence from systematic reviews, randomised controlled trials, and international clinical guidelines. Content is reviewed and updated at least every 12 months to reflect the latest evidence.
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