HMG-CoA Reductase Inhibitor · Brand: Crestor, Ezallor Sprinkle
Rosuvastatin Side Effects: Common, Serious & FDA Warnings
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Quick answer
Based on 223,000+ FDA adverse event reports, the most-reported rosuvastatin reactions include fatigue, nausea, and dyspnoea. FDA reports 3 active Class II recalls of rosuvastatin, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Rosuvastatin
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for rosuvastatin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Fatigue | 14,313 | 6.4% |
| Nausea | 12,070 | 5.4% |
| Dyspnoea | 11,639 | 5.2% |
| Diarrhoea | 10,982 | 4.9% |
| Pain | 10,623 | 4.7% |
| Headache | 9,811 | 4.4% |
| Myalgia | 9,923 | 4.4% |
| Dizziness | 9,087 | 4.1% |
| Arthralgia | 8,901 | 4.0% |
| Asthenia | 8,523 | 3.8% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
From the FDA-approved label, Section 5.1: Myopathy and Rhabdomyolysis
Rosuvastatin may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher rosuvastatin dosage.Show full Section 5.1
Asian patients on rosuvastatin may be at higher risk for myopathy [see Drug Interactions ( 7.1 ) and Use in Specific Populations ( 8.8 )] . The myopathy risk is greater in patients taking rosuvastatin 40 mg daily compared with lower rosuvastatin dosages. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin with cyclosporine or gemfibrozil is not recommended. Rosuvastatin dosage modifications are recommended for patients taking certain antiviral medications, darolutamide, and regorafenib [see Dosage and Administration ( 2.6 )] . Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions ( 7.1 )] . Discontinue rosuvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if rosuvastatin is discontinued. Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the rosuvastatin dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
From the FDA-approved label, Section 5.4: Proteinuria and
Hematuria In the rosuvastatin clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients. These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, consider a dose reduction for patients on rosuvastatin therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
Rosuvastatin Recalls
FDA enforcement actions matched to rosuvastatin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2026-01-14 | Out of specification for dissolution. AvKARE | Class II | 7,991 5x10 cartons | Ongoing |
| 2025-04-16 | CGMP Deviations Glenmark Pharmaceuticals Inc., USA | Class II | N/A | Ongoing |
| 2023-04-12 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Preferred Pharmaceuticals, Inc. | Class II | a) 59 Bottles, b) 77 Bottles | Ongoing |
Show 4 closed recalls (2023 to 2023)
Includes resolved and terminated recalls matched to rosuvastatin. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 43,302 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 63,247 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 102,360 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 56,862 bottles | Terminated |
Rosuvastatin Shortages
FDA-listed shortages of rosuvastatin products. Strength and dosage-form level detail.
No active or recent shortages of rosuvastatin are listed. We refresh this view daily.
Is Rosuvastatin Safe?
Rosuvastatin is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers myopathy and rhabdomyolysis (Section 5.1), immune-mediated necrotizing myopathy (Section 5.2), hepatic dysfunction (Section 5.3), proteinuria and (Section 5.4), increases in hba1c and fasting serum glucose levels (Section 5.5).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Rosuvastatin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Rosuvastatin tablets is indicated: To reduce the risk major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Show full Indications and Usage
Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin tablets is an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. to reduce LDL-C and slow the progression of atherosclerosis in adults. to reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Frequently Asked Questions
What are the most-reported side effects of rosuvastatin?
Fatigue, nausea, and dyspnoea are among the most-reported reactions in FDA FAERS data for rosuvastatin. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is rosuvastatin the same as Crestor?
Rosuvastatin is the generic name; Crestor is a brand name for the same active ingredient. Other brand names include Ezallor Sprinkle. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has rosuvastatin been recalled?
Yes. Rosuvastatin has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations and failed dissolution specifications. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are rosuvastatin's current ongoing recalls about?
Active rosuvastatin recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are CGMP deviations and failed dissolution specifications. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.