Adverse effects of iodixanol: A retrospective safety study utilizing FAERS database signal analysis

Medicine (Baltimore). 2025 Dec 5;104(49):e44714. doi: 10.1097/MD.0000000000044714.

ABSTRACT

This retrospective study utilized the Food and Drug Administration adverse event (AE) reporting system database (Q1 2004-Q4 2024) to comprehensively evaluate the safety profile of the contrast agent iodixanol. Disproportionality analysis (reporting odds ratio, proportional reporting ratio, information component, empirical Bayes geometric mean) was employed to detect AE signals. Analysis of 2212 iodixanol AE reports revealed an increasing reporting trend, peaking in 2014 (10.85%). Males reported more AEs (41.46%) than females (37.39%), and the US contributed the most reports (20.75%). Intravenous administration was predominant (57.32%), with most AEs occurring within 48 hours (79.90%). Skin/subcutaneous tissue disorders were the most frequent system organ class signal (n = 1450), followed by general disorders/administration site conditions (n = 744) and respiratory disorders (n = 681). Pruritus (n = 307), urticaria (n = 201), and dyspnea (n = 198) were the top preferred term signals. Compared to iohexol and iopamidol, iodixanol demonstrated unique high-risk cardiovascular signals (e.g., coronary no-reflow) and a higher incidence of serious reactions in specific populations (low-weight, obese, elderly). Logistic regression identified younger age (≤44 years) and procedures (computed tomography, angiography) as significant risk factors for severe skin reactions. Notably, 59 novel preferred term signals not on the label were detected. This large-scale pharmacovigilance study confirms known iodixanol risks, identifies novel safety signals, and highlights populations and procedures requiring heightened vigilance. The findings inform clinical practice and regulatory decisions regarding contrast agent safety.

PMID:41366928 | DOI:10.1097/MD.0000000000044714