Methods: Individual case safety reports by RCM submitted spontaneously to our regional pharmacovigilance center from March 2014 to February 2015. We analysed all cases of adverse reactions after intravenous injection of iodinated contrast media (ICM; iohexol, iomeprol, ioversol, iopamidol, iopamide, and iobitridol) and gadolinum contrast (ganotenate, gadobutrol, gadobenate, and gadoxetate).
Results: Of total 293 adverse reactions of RCM, 278 (94.9%) were developed after ICM injection, and 15 (5.1%) was caused by gadolinum contrast. Overvall incidence of ICM adverse reactions was 1.28%. Mean age of case subjects was 54.15 ± 14.80, and 139 (46.5%) were men. There was no subject who had positive response to pre-test skin test to predict adverse reaction before imaging. Among ICMs, iobitridol showed highest rate of all adverse reactions (2.60%). Most common adverse reactions were cutaneous reactions (236, 84.9%), and gastrointestinal reactions (29, 10.4%). Classified into severity, mild reactions were 202 (72.7%), moderate and severe reactions were 65 (23.4%) and 11 (4.0%), respectively. Incidence of severe reactions was iobitridol (0.14%), iopromide (0.054%), and ioversol (0.027%). Regarding adverse reactions by gadolinium contrast, all reactions were mild (11, 73.3%), and moderate (4, 26.7%). There was no severe reaction caused by gadolinium contrast.
Conclusions: RCM skin testing for screening shows no efficacy to predict adverse reactions. The incidence of adverse reactions was relatively higher in ICM than gadolinium contrast. Among ICMs, iobitridol may develop adverse reactions more frequently, and more serious ones.