Atorvastatin-associated neurological adverse events: a disproportionality analysis with adjustment for confounding by indication - Report - MDSpire

Atorvastatin-associated neurological adverse events: a disproportionality analysis with adjustment for confounding by indication

  • By

  • Xinjun He

  • Qi Zhou

  • Min Zhang

  • Dandan Wang

  • Xinchang Xu

  • July 7, 2026

  • 0 min

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Clinical Report: Neurological Adverse Events Linked to Atorvastatin

Overview

This study identifies multiple neurological adverse events associated with atorvastatin, based on a disproportionality analysis of the FAERS database.

Background

Atorvastatin is a commonly prescribed statin for managing hyperlipidemia and coronary artery disease. While it is known for its cardiovascular benefits, there is an association with neurological adverse events.

Data Highlights

Adverse EventPRRχ2EBGM05
Myasthenia gravis5.65748.224.82
Axonal neuropathy6.15117.784.14
Peripheral sensory neuropathy3.42182.342.80
Encephalitis toxic7.7617.112.39
Brain fog2.94168.762.46
Acute necrotising myelitis832.92N/A38.61
Vibration syndrome37.02N/A14.51
Radiculitis brachial26.03N/A13.57

Key Findings

  • 32 neurological adverse event signals remained significant after excluding confounding factors.
  • Myasthenia gravis had a PRR of 5.65, indicating a strong association with atorvastatin.
  • Axonal neuropathy and peripheral sensory neuropathy also showed significant PRR values of 6.15 and 3.42, respectively.
  • Encephalitis toxic and brain fog were identified as notable central nervous system disorders linked to atorvastatin.
  • Acute necrotising myelitis exhibited an exceptionally high PRR of 832.92, indicating a rare but significant risk.

Clinical Implications

Clinicians should be aware of the neurological adverse events associated with atorvastatin.

Conclusion

Further validation of these signals is necessary.

Related Resources & Content

  1. Attardo et al., Drug Safety, 2023 -- Neurological Adverse Events Linked to Atorvastatin
  2. FDA, ATORVALIQ (atorvastatin calcium) oral suspension, 2024 -- Label Information
  3. New England Journal of Medicine, 2006 -- High-Dose Atorvastatin after Stroke or Transient Ischemic Attack
  4. Drug Safety — Neurocognitive Adverse Drug Reactions Associated with PCSK9 Inhibitors: A Review of Individual Case Safety Reports from the Eudravigilance Database
  5. Drugs - Real World Outcomes — Evaluation of the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort Study in a Real-World Setting
  6. Frontiers in Cardiovascular Medicine — Atorvastatin and almonertinib-induced myopathy in a polypharmacy context: a case report
  7. Statin use and dementia risk: A systematic review and updated meta‐analysis
  8. ATORVALIQ (atorvastatin calcium) oral suspension
  9. High-Dose Atorvastatin after Stroke or Transient Ischemic Attack | New England Journal of Medicine

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