Cutaneous Adverse Reactions to Iodinated and Gadolinium-based Contrast Agents: A FAERS Disproportionality and Phenotype Analysis

Document Type

Conference Proceeding - Restricted Access

Publication Date

5-8-2026

Abstract

Iodinated contrast media (ICM) and gadolinium-based contrast agents (GBCAs) are commonly used in modern diagnostic imaging. Following ICM administration, both immediate and nonimmediate cutaneous reactions have been reported. The incidence of these reports has rapidly increased in recent years, prompting clinicians to reevaluate contrast agent safety for future imaging patients. However, research is limited on comparative, real-world data on specific cutaneous phenotypes across multiple contrast families. This study aims to provide a comprehensive overview of cutaneous adverse reactions to ICM and GBCAs using data from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS), which contains spontaneous adverse event reports submitted by healthcare professionals, manufacturers, and consumers worldwide.

We conducted a retrospective pharmacovigilance study using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). All data processing and analyses were conducted in R (version 4.5.2). Publicly available quarterly ASCII datasets were downloaded from the FDA website and included reports from 2012 Q1 through 2025 Q3. Across all FAERS quarters analyzed, over 16 million unique reports were included after deduplication. Contrast agent exposure was identified using the FAERS DRUG files, and agents were classified into two exposure groups: gadolinium-based contrast agents (GBCAs) and iodinated contrast media (ICM). Cutaneous adverse events were identified from the FAERS REAC files using MedDRA Preferred Terms (PTs). The following complementary signal-detection metrics were calculated: reporting odds ratio (ROR), proportional reporting ratio (PRR), and bayesian information component (IC).

GBCAs demonstrated strong disproportional reporting for several cutaneous reactions. The most prominent signals included: Urticaria (ROR 27.99; 95% CI 26.64-29.4; PRR 23.26; IC025 4.20), Erythema (ROR 8.42; 95% CI 7.85-9.02; PRR 7.84; IC025 2.67), and Pruritus (ROR 7.43; 95% CI 7.01-7.87; PRR 6.67). Moderate but statistically significant signals were also observed for angioedema and rash. In contrast, dermatitis, toxic epidermal necrolysis, and DRESS did not meet signal criteria for GBCAs, with ROR confidence intervals crossing unity and negative IC025 values. ICM exposure was similarly associated with multiple cutaneous adverse events, though effect sizes were generally smaller than those observed for GBCAs: Urticaria (ROR 20.08; 95% CI 19.08-21.14; PRR 17.55; IC025 3.82), Erythema (ROR 9.01; 95% CI 8.46-9.59; PRR 8.34; IC025 2.78), and Pruritus (ROR 7.8; 95% CI 7.4-8.22; PRR 6.96). Notably, severe cutaneous adverse reactions showed positive signals for ICM, including Toxic epidermal necrolysis (ROR 2.38; 95%

Both contrast agent classes-ICM and GBCAs-exhibited strong disproportionality signals for immediate hypersensitivity-type cutaneous adverse reactions, including urticaria, pruritus, erythema, and angioedema. GBCAs were associated with urticaria, pruritus, erythema, and angioedema, with higher relative reporting odds for several reactions compared with ICM. Conversely, ICM demonstrated signals for rare but severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Future research should prioritize prospective studies to validate and refine these results.

Comments

2026 Research Day Corewell Health West, Grand Rapids, MI, May 8, 2026. Abstract 1938

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