Real-world evidence on gadoteridol safety: A 20-year FAERS database study revealing critical adverse reaction...

Gadoteridol, a gadolinium-based contrast agent used for magnetic resonance imaging, has been used in clinical settings since its approval in the United Kingdom in 1992. Although its efficacy in enhancing imaging results is well established, investigating its associated adverse reactions remains critically important. This study aimed to comprehensively assess the safety profile of gadoteridol-related adverse drug events (ADEs), as reported in the FDA Adverse Event Reporting System (FAERS) database. Adverse event reports on gadoteridol spanning from the first quarter of 2004 to the fourth quarter of 2024 were extracted from the FAERS database. The analysis employed 4 complementary signal-detection methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and Bayesian confidence propagation neural network (BCPNN), to identify and evaluate adverse drug event signals. The data were processed and analyzed using R software. During the entire study period, a total of 1158 reports of ADEs related to gadoteridol were identified, with the highest number reported in 2021, accounting for 11.61% of the total reports. Most reports were from patients aged > 60 years, representing 32.36% of the total. Regarding sex distribution, a greater number of reports were filed for female patients (58.17%) than for male patients (37.31%). Geographically, the United States contributed 45.63% of all reports. Notably, adverse reaction outcomes indicated that "other serious" reactions were predominant, accounting for 50.91% of all cases. Signal analysis revealed that, among 19 system organ classes examined, neurological diseases were the most frequently reported (501 cases), followed by systemic diseases (411 cases) and respiratory diseases (376 cases). Specific analyses of adverse reaction signals demonstrated the strongest associations with respiratory illnesses, immune system disorders, and skin-related conditions. This study offers a systematic examination of adverse event signals associated with gadoteridol using data from the FAERS database. These findings highlight notable reporting signals involving neurological, systemic, and immune-related conditions. This information is crucial for clinical practitioners prescribing gadoteridol and may contribute to enhancing patient safety and informing future regulatory actions concerning contrast agents.