Real-world safety evaluation of atorvastatin: insights from the US FDA adverse event reporting system (FAERS)

Abstract

Objective: Given the extensive use of atorvastatin in managing cardiovascular conditions and the surge in reported adverse drug reactions (ADRs), this study leverages the FAERS database to comprehensively evaluate atorvastatin-associated adverse events, thereby enhancing our understanding of its safety profile in real-world settings.

Methods: A retrospective observational pharmacovigilance study was conducted using FAERS data from Q1 2004 to Q1 2024. Four algorithms - ROR, PRR, BCPNN, and EBGM - were employed to detect signals of adverse events (AEs) linked to atorvastatin through disproportionality analysis.

Results: Out of 17,627,340 reports in the FAERS database 81,955 involved atorvastatin. Consistently identified AEs across all four algorithms included musculoskeletal and connective tissue disorders, metabolic and nutritional disorders, and hepatobiliary disorders at the system organ class (SOC) level. A total of 4,575 significant disproportionate preferred terms (PTs) were observed across 23 SOCs, with key PTs being 'immune-mediated myositis,' 'type 2 diabetes mellitus,' 'necrotizing myositis,' 'autoimmune myositis,' and 'myopathy.' Additionally, unexpected AEs such as erectile dysfunction were identified. The median onset time for these AEs was 60 days, with most occurring within the first 30 days of treatment.

Conclusion: This study identified both expected and unexpected AEs associated with atorvastatin, highlighting the need for continued surveillance and providing valuable insights for clinicians to optimize atorvastatin use and address safety concerns.

Keywords: Atorvastatin; FAERS; Statins; adverse event; pharmacovigilance.