Major adverse events related to atorvastatin calcium hydrocarbons: pharmacovigilance study in the FAERS database

This study analyzed safety data for atorvastatin calcium hydrate (ACH) using real-world adverse event reports from the U.S. FDA Adverse Event Reporting System (FAERS, 2004-2024) and the European Medicines Agency's EudraVigilance (EV, 2002-2024). A total of 104 798 ACH-related reports were included: 67 498 from FAERS and 37 300 from EV. Four signal detection algorithms (ROR, PRR, BCPNN, and MGPS) identified 597 significant positive signals, 356 in FAERS and 241 in EV, covering 27 system organ classes. FAERS signals mainly involved metabolic, cardiac, and nervous system disorders, while EV was dominated by examination abnormalities (66 signals, 27.39%) and musculoskeletal disorders (29 signals, 12.03%). Rhabdomyolysis and drug-induced liver injury were major designated medical events in both databases. EV also identified liver failure, hepatocellular injury, and death (1833 cases, 4.91%) as key serious outcomes. Stratified analyses showed elderly patients in FAERS had higher risks of type 2 diabetes and emotional distress. In EV, patients aged ≥65 years accounted for 34.12%, females 49.83% versus males 37.21%, and severe cases reached 94.50%. The study recommends close clinical monitoring for rhabdomyolysis, liver injury, and fatal outcomes, with special attention to liver function and muscle symptoms in elderly, diabetic, emotionally distressed, and female patients.