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Lipid-Lowering Drugs: Statins and Miscellaneous Agents01:20

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Updated: Mar 22, 2026

Induction and Assessment of Exertional Skeletal Muscle Damage in Humans
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Induction and Assessment of Exertional Skeletal Muscle Damage in Humans

Published on: December 11, 2016

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Muscle rupture associated with statin use.

Corine Ekhart1, Loek de Jong1, Liana Gross-Martirosyan2

  • 1Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.

British Journal of Clinical Pharmacology
|April 14, 2016
PubMed
Summary

Statins, commonly prescribed for high cholesterol, are linked to muscle rupture, a rare but serious adverse drug reaction. Healthcare providers and patients should be aware of this potential risk.

Keywords:
adverse drug reactionmuscle rupturestatins

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Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Musculoskeletal Medicine

Background:

  • Statins are widely prescribed globally for hyperlipidaemia management.
  • Musculoskeletal adverse drug reactions are known side effects of statin therapy.
  • Muscle rupture has not been previously established as a statin-associated adverse drug reaction.

Observation:

  • A review of pharmacovigilance databases identified cases of muscle rupture linked to statin use.
  • The Netherlands Pharmacovigilance Centre Lareb reported 15 cases.
  • The EudraVigilance database contained 165 reports of muscle rupture in statin users.

Findings:

  • A plausible temporal association between statin use and muscle rupture was observed in most cases.
  • Both databases indicated a disproportionate association between statin use and muscle rupture.
  • Reporting odds ratios were significantly elevated, suggesting a potential causal link.

Implications:

  • Findings suggest that statin use may be associated with an increased risk of muscle rupture.
  • Physicians should consider muscle rupture in patients presenting with relevant symptoms while on statin therapy.
  • Increased awareness among healthcare professionals and patients regarding this potential adverse drug reaction is warranted.