Temsirolimus safety evaluation: real-world adverse event analysis from the FDA adverse event reporting system...

Temsirolimus is a mammalian target of rapamycin inhibitor primarily used to treat not only various types of renal carcinoma, but also various types of lymphomas and other tumors. However, its real-world safety profile remains inadequately characterized. By analyzing the Food and Drug Administration Adverse Event Reporting System (FAERS) database, we identified risk signals associated with temsirolimus adverse reactions and gained valuable insights for clinical decision-making and risk management. We extracted temsirolimus-related reports of adverse events (AEs) from FAERS across 68 quarters (Q2 2007-Q2 2024) and analyzed the demographic characteristics. Disproportionality analyses-including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM)-were conducted to evaluate the association between temsirolimus and adverse events. When a signal simultaneously meets the threshold criteria of all four algorithms, it is considered a significantly positive signal. We compared the significant positive signals obtained with those in the drug label and ultimately identified new adverse reactions that had not been discovered. We extracted 2,929 adverse event reports from the Food and Drug Administration Adverse Event Reporting System (FAERS) database in which temsirolimus was identified as the "primary suspect"drug. Through disproportionality analysis, we identified 128 preferred terms (PTs) associated with temsirolimus across 17 organ systems. The significant adverse reactions consistent with the drug label were observed, including hypersensitivity/infusion reactions, liver injury, hyperglycemia/insulin resistance, infections, interstitial lung disease, hyperlipidemia, intestinal perforation, renal failure, wound complications, and intracranial hemorrhage. Additionally, the new positive signals not documented in the drug label were identified, including dehydration, pleural effusion, cardiac failure, and ascites. Our findings are basically consistent with prior clinical studies, and the new potential adverse events (AEs) associated with temsirolimus were identified. These insights contribute to ongoing pharmacovigilance efforts, enhancing safety monitoring and optimizing clinical application.