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Pharmacol."],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"<jats:p>This study analyzed safety data for atorvastatin calcium hydrate (ACH) using real\u2013world adverse event reports from the U.S. FDA Adverse Event Reporting System (FAERS, 2004\u20132024) and the European Medicines Agency\u2019s EudraVigilance (EV, 2002\u20132024). A total of 104\u2009798 ACH\u2013related reports were included: 67\u2009498 from FAERS and 37\u2009300 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\u2013induced liver injury were major designated medical events in both databases. 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