Adverse Drug Event Profile of Radiocontrast Iodine in Elderly: A Retrospective Focused Pharmacovigilance-Based Disproportionality Analysis Study

Background: Radiocontrast agents are widely used in imaging procedures; however, their safety profile in elderly patients remains inadequately characterized. This study aims to evaluate the adverse drug events (ADEs) reported with radiocontrast iodine in this vulnerable population. Methods: A retrospective analysis was conducted using the US FDA Adverse Event Reporting System database. Reports pertaining to adverse events linked to radiocontrast iodine in patients aged 65 and older were extracted. Signal detection was performed using frequentist and Bayesian methods to identify significant ADEs and their relationship with specific radiocontrast agents. Demographic characteristics and outcomes were also assessed. Results: Out of 29 153 222 reports in the AERS database, 2640 unique reports related to adverse events in the elderly population were included. Key findings revealed significant signals including hypersensitivity reactions, cardiac disorders, renal failure, pancreatitis, and neuropsychiatric events. Notably, distinct adverse effects were observed for individual agents: iodixanol was linked to pancreatitis and vasculitis, while iohexol was associated with hyperthyroidism. Additionally, the study noted that 11.6% of reported cases resulted in death, 22.1% of reported adverse events were life-threatening, and 34.8% of reported cases required hospitalization. Conclusion: This study underscores the importance of vigilance in monitoring ADEs associated with radiocontrast iodine in elderly patients. Although common reactions were identified, emergent signals such as pancreatitis and neuropsychiatric events warrant further investigation to establish causality and improve patient safety. Future research should focus on prospective studies and the development of risk assessment tools tailored for this demographic.