Pharmacovigilance analysis of iodinated contrast media related respiratory adverse effects based on the FDA adverse event reporting system.

AIM: Iodinated contrast media (ICM) serve as a cornerstone in diagnostic imaging; however, the risk profile of their respiratory system adverse reactions remains inadequately characterized. This study aims to quantify and compare the respiratory system adverse reaction signals associated with four widely utilized non-ionic ICMs-iohexol, iopamidol, iopromide, and ioversol-using the United States Food and Drug Administration's Adverse Event Reporting System (FAERS) database.

METHODS

We extracted data from the FAERS database spanning the first quarter of 2004 to the fourth quarter of 2024. Signal detection was performed employing the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) methodologies to identify statistically significant drug-event associations.

RESULTS

A total of 9,682 adverse event (AE) reports related to the respiratory system were analyzed, encompassing 53 distinct respiratory-related events. All four ICMs demonstrated a significant correlation with respiratory diseases. Notably, the analysis revealed that certain adverse reactions were not covered in the prescribing information. Moreover, sneezing and laryngeal edema exhibited unusually high signal intensities across all four ICMs.

CONCLUSION

This study reveals heterogeneity in the respiratory system risk profiles among the four commonly used non-ionic ICMs. These findings suggest that clinical decision-making should incorporate the distinct risk profiles of specific ICMs, and individualized monitoring strategies should be implemented for high-risk patients.