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April 20, 2026Journal of the American College of Cardiology746 citations

Statin-Associated Side Effects

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PTPaul M. ThompsonGPGregory A. PanzaAZAmanda L. Zaleski

Key Result

Statin-associated muscle symptoms are the most frequent side effect, with mild myalgia affecting 5% to 10% of users, while severe symptoms like rhabdomyolysis remain rare.

Key Points

  • The research aims to clarify the relationship between statin use and associated symptoms, particularly muscle-related issues.
  • Review of clinical trial data on statin tolerability and associated symptoms.
  • Analysis of incidence rates of statin-associated symptoms, especially muscle symptoms and diabetes mellitus.
  • 5% to 10% of statin users report mild muscle symptoms (myalgia).
  • Rhabdomyolysis and statin-induced necrotizing autoimmune myopathy are rare but serious conditions.
  • Strong association found between statins and diabetes mellitus, while other SAS evidence is mainly anecdotal.

Structured PICO

What are the common statin-associated side effects and how should they be managed in statin users?

P
Population
Statin users
I
Intervention
Statins (HMG-CoA reductase inhibitors)
O
Outcome
Statin-associated symptoms (SAS) including muscle symptoms, diabetes mellitus, and central nervous system complaintssafety

Statin-associated symptoms, particularly muscle symptoms and diabetes, are important clinical considerations that require appropriate diagnosis and management to avoid unnecessary discontinuation of life-saving lipid-lowering therapy.

Abstract

Hydroxy-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors or statins are well tolerated, but associated with various statin-associated symptoms (SAS), including statin-associated muscle symptoms (SAMS), diabetes mellitus (DM), and central nervous system complaints. These are "statin-associated symptoms" because they are rare in clinical trials, making their causative relationship to statins unclear. SAS are, nevertheless, important because they prompt dose reduction or discontinuation of these life-saving mediations. SAMS is the most frequent SAS, and mild myalgia may affect 5% to 10% of statin users. Clinically important muscle symptoms, including rhabdomyolysis and statin-induced necrotizing autoimmune myopathy (SINAM), are rare. Antibodies against HMG-CoA reductase apparently provoke SINAM. Good evidence links statins to DM, but evidence linking statins to other SAS is largely anecdotal. Management of SAS requires making the possible diagnosis, altering or discontinuing the statin treatment, and using alternative lipid-lowering therapy.

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Cite This Study

Thompson et al. (2016) conducted a review in Statin-associated symptoms. Statins (HMG-CoA reductase inhibitors) was evaluated. Statin-associated muscle symptoms are the most frequent side effect, with mild myalgia affecting 5% to 10% of users, while severe symptoms like rhabdomyolysis remain rare.

synapsesocial.com/papers/69e5ef84f5d1af861d55efa5https://doi.org/10.1016/j.jacc.2016.02.071
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