ArticlePloS one2025
Hepatotoxicity associated with statins: A retrospective pharmacovigilance study based on the FAERS database.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed.
- HLA and non-HLA genetic analyses reveal suggestive variants associated with statin-induced liver injury.Hepatology communications · 2026Article
- A Case of Statin-Induced Fulminant Hepatitis Presenting as Septic Shock and Multiorgan Failure.Cureus · 2026Article
- Article
- Cost-Effectiveness of Pitavastatin in Dyslipidemia: A Systematic Review.Healthcare (Basel, Switzerland) · 2026Review
- Coenzyme Q10 protects against atorvastatin-induced hepatotoxicity via attenuation of oxidative stress and functional modulation of CYP3A1.BMC pharmacology & toxicology · 2026Article
- Efficacy and Safety of Statins in MASLD and Other Chronic Liver Diseases.Medical sciences (Basel, Switzerland) · 2026Review
- Protective Role of Lipid-Lowering Drugs in Breast Cancer: Effects on Cancer Incidence and Cardiotoxicity.Life (Basel, Switzerland) · 2025Review
- Microalgae-Derived Peptides Targeting Lifestyle-Related Diseases: Discovery, Mechanisms, Structure-Activity Relationships, and Structural Modifications.Antioxidants (Basel, Switzerland) · 2025Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStatins are commonly prescribed in clinical practice and are associated with a high risk of drug-induced liver injury (DILI). This study aims to examine the real-world data on statin-induced liver injury to assess medication safety.
methodsAll DILI cases reported with statins as primary suspected drugs were extracted based on the US Food and Drug Administration adverse event reporting system (FAERS) from 2004 to 2023. A disproportional analysis was conducted using reported odds ratios (ROR) and information component (IC) to assess the significant association between statins and DILI.
resultsA total of 7779 statin-associated DILI cases were identified. DILI patients tended to be aged >65 years (45.43%), with more females than males (48.80% vs 43.75%), and 39.95% of DILI patients required hospitalization. Statin-induced DILI cases are most commonly reported with atorvastatin (53.48%), rosuvastatin (20.44%), and simvastatin (19.46%). The DILI signals (ROR; 95% CI) for statins were ranked as follows: fluvastatin (6.90; 5.89-8.10)> atorvastatin (3.09; 2.99-3.19)> simvastatin (2.96; 2.81-3.12)> lovastatin (2.77; 2.17-3.53)> rosuvastatin (2.27; 2.16-2.39)> pravastatin (2.07; 1.81-2.37). Age-stratified analysis showed that a stronger signal was detected in patients (aged ≥65 years) than patients (aged <65 years) for atorvastatin, simvastatin, pravastatin and fluvastatin. The onset time of DILI was significantly different among the different statins (p = 0.014), and simvastatin resulted in the highest mortality rate (12.15%).
conclusionBased on FAERS database, six statins are significantly associated with liver injury, and fluvastatin, atorvastatin, and simvastatin had the greatest risk of DILI.
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