Abstract
This study analyzes adverse drug events (ADEs) associated with Tivozanib, sourced from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. We collected ADE data for Tivozanib from 2021 Q2 through 2023 Q4. Post-standardization, we employed several signal quantification methods for analysis, such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propensity for Neural Networks (BCPNN), and the Multi-item Gamma Poisson Shrinker (MGPS). In this analysis of 1,142 ADE reports citing Tivozanib as the primary suspect, we identified 69 adverse reaction terms (PTs) across 21 system organ classifications (SOCs). The three most prevalent SOCs were general disorders and administration site conditions (841 incidents, ROR 1.27, PRR 1.21, IC 0.28, EBGM 1.14), gastrointestinal disorders (669 incidents, ROR 2.52, PRR 2.25, IC 1.17, EBGM 2.25), and investigations (322 incidents, ROR 1.45, PRR 1.42, IC 0.5, EBGM 1.42). Notably, fatigue and hypertension were the most frequently reported adverse events associated with Tivozanib, with hypothyroidism also demonstrating significant signal intensity. While Tivozanib offers therapeutic benefits, it also carries the risk of several adverse reactions. Clinicians should vigilantly monitor patients for signs of fatigue, hypertension, hypothyroidism, and other events during its clinical use.