Rosuvastatin 40 mg side effects

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Rosuvastatin 40 mg Side Effects: Safety Profile and Risks

General Safety and Common Side Effects of Rosuvastatin 40 mg

Rosuvastatin 40 mg is considered to have a safety profile similar to other statins at approved doses. The most common side effects are muscle-related, such as myopathy (muscle pain or weakness), but the risk at 40 mg is comparable to other statins. Serious muscle breakdown (rhabdomyolysis) is rare at this dose, but the risk increases significantly at higher doses (such as 80 mg) .

Muscle-Related Side Effects: Myopathy and Rhabdomyolysis

Myopathy and rhabdomyolysis are the most concerning side effects of high-dose rosuvastatin. While the incidence of myopathy at 40 mg is similar to other statins, certain patients are at higher risk. These include older adults, those with impaired kidney or liver function, and individuals taking other medications that affect statin metabolism. Genetic differences in drug metabolism (such as variations in the SLCO1B1, ABCG2, and CYP2C9 genes) can also increase the risk of muscle toxicity and rhabdomyolysis, potentially leading to acute kidney injury 135.

Liver Effects and Laboratory Abnormalities

At doses of 40 mg or higher, rosuvastatin can cause mild to moderate liver changes, such as increased liver enzymes (AST, ALT, ALP) and bilirubin. In animal studies, liver toxicity was observed at doses equivalent to or above 40 mg/kg, including changes in liver cells and bile ducts. These findings suggest that the liver is a target organ for potential toxicity, especially at higher exposures .

Kidney Effects: Proteinuria and Renal Function

A small proportion of patients taking rosuvastatin 40 mg may develop transient proteinuria (protein in the urine), which is usually mild, of tubular origin, and not associated with a decline in kidney function. Long-term studies show that serum creatinine levels remain stable, indicating no significant impact on overall renal function for most patients. However, those with pre-existing kidney disease or other risk factors should be monitored closely .

Risk Factors That Increase Side Effects

Certain factors can increase the risk of side effects with rosuvastatin 40 mg:

Advanced age
Impaired kidney or liver function
Genetic variations affecting drug metabolism
Concomitant use of drugs that interact with rosuvastatin
Higher doses than recommended, especially in specific populations (e.g., Asian descent, where 40 mg is contraindicated due to higher drug exposure) 35

Monitoring and Precautions

Patients on rosuvastatin 40 mg should have regular monitoring of muscle enzymes (creatine kinase), liver function tests, and kidney function (serum creatinine, urine protein). Genetic testing may help identify those at higher risk for side effects. Dose adjustments or alternative therapies should be considered for high-risk individuals 35.

Conclusion

Rosuvastatin 40 mg is generally safe and effective for lowering cholesterol, with a side effect profile similar to other statins at approved doses. The main risks are muscle-related side effects, liver enzyme elevations, and transient proteinuria. These risks are higher in certain populations, especially those with genetic predispositions, older age, or impaired kidney/liver function. Careful patient selection, dose adjustment, and regular monitoring can help minimize serious side effects.

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Most relevant research papers on this topic

Rosuvastatin safety: lessons from the FDA review and post-approval surveillance

Rosuvastatin has a similar safety profile to other statins up to 40 mg, with a higher incidence of adverse effects when doses increase from 40 to 80 mg.

Highly Cited

2004·

81citations

·M. Davidson

Non-clinical safety evaluation of a novel pharmaceutical salt, rosuvastatin ethanolamine, in Wistar rats

Rosuvastatin ethanolamine shows toxicities to liver at 40 mg/kg in rats, with potential implications for future assessments of potential Rosuvastatin toxicities.

Non-RCTAnimal StudyRigorous Journal

2019·

1citation

·J. Vaghasiya et al.

#2436 Genetic variability in rosuvastatin metabolism explains rhabdomyolysis and consequent acute renal failure

Genetic variability in rosuvastatin metabolism can increase the risk of rhabdomyolysis and acute renal failure, highlighting the need for cautious statin prescribing and monitoring.

Case Report

2024·

1citation

·Gregor Mlinšek et al.

Comparison of short-term renal effects and efficacy of rosuvastatin 40 mg and simvastatin 80 mg, followed by assessment of long-term renal effects of rosuvastatin 40 mg, in patients with dyslipidemia.

Rosuvastatin 40 mg effectively lowers cholesterol levels, enabling more patients to achieve LDL-C goals, with minimal long-term renal effects.

RCTLarge Human Trial

2007·

5citations

·E. Stein et al.

Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19

Hydroxychloroquine is a safe and effective treatment for early COVID-19 in nonhospitalized adults, with no known interactions or interactions with other drugs.

Case ReportRigorous JournalHighly Cited

2021·

397citations

·Claudia N. Paiva et al.

Effects of early administration of high-dose rosuvastatin on coronary microvascular function and short-term outcome in patients treated with primary percutaneous coronary intervention for acute myocardial infarction

Early administration of high-dose rosuvastatin (40 mg) improves coronary microvascular function and short-term outcomes in patients treated with primary percutaneous coronary intervention for acute myocardial infarction, with no cytotoxicity or hepatotoxicity observed.

RCT

2016·

0citations

·Guodong Chang et al.

Short Term Comparison Between Safety and Efficacy of Rosuvastatin 40 mg and Atorvastatin 80 mg in Patients with Acute Coronary Syndrome

Rosuvastatin 40 mg/day is safer and more effective than atorvastatin 80 mg/day in reducing lipid parameters and inflammatory biomarkers in patients with acute coronary syndrome.

RCT

2018·

3citations

·Sh. A. Mostafa et al.

Effects of high rosuvastatin doses on hepatocyte mitochondria of hypercholesterolemic mice

High doses of rosuvastatin can cause premature death in hypercholesterolemic mice, while moderate doses cause morphological and functional alterations in liver mitochondria, but these effects are less severe.

Non-RCTAnimal StudyRigorous Journal

2021·

8citations

·J. C. Díaz-Zagoya et al.

Lipid-lowering efficacy of rosuvastatin.

Rosuvastatin effectively reduces LDL-cholesterol by 46% to 55%, with a dose-dependent effect on total blood cholesterol, and increases HDL-cholesterol by 7%.

Meta-AnalysisVery Rigorous Journal

2017·

57citations

·S. Adams et al.

Lipid-lowering therapy for patients with arterial hypertension and concomitant chronic obstructive pulmonary disease in a south American cohort.

Rosuvastatin at a dose of 40 mg effectively reduces total cholesterol, LDL, and triglycerides, improves endothelial function, and is safe for patients with dyslipidemia, hypertension, and COPD.

Non-RCT

2023·

0citations

·Diego Lobo et al.

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