Safety Profiles of Ionic and Non-Ionic Contrast Agents Used in Percutaneous Coronary Intervention: Analysis of FAERS Data

Abstract

Background: Contrast agents are used in percutaneous coronary intervention (PCI), yet differences in adverse event profiles between ionic and non-ionic agents remain incompletely characterized. This study aimed to evaluate patient demographics, adverse event patterns, and seriousness of outcomes associated with contrast agents reported in the U.S. FDA Adverse Event Reporting System (FAERS). Materials and Methods: Data were extracted from FAERS for reports involving contrast agents used during PCI, including both ionic (low- and high-osmolar) and non-ionic agents. Datasets were cleaned for duplicates and incomplete records, and product names, patient demographics, and adverse reactions were standardized. Descriptive statistics were calculated for continuous (age, weight) and categorical (sex, seriousness, adverse reactions) variables. Comparative analyses between ionic and non-ionic groups were performed using t-tests for continuous variables and chi-square tests for categorical outcomes. Data visualization was performed using Python libraries. Results: A total of 72 cases were identified, including 18 ionic (25%) and 54 non-ionic (75%) reports. Mean patient ages ranged from 52.8 to 71.0 years across individual agents, with weight varying from 69.7 to 92.9 kg. Adverse events differed by agent type: ionic agents were primarily associated with renal failure and hypersensitivity reactions, while non-ionic agents exhibited broader nephrotoxic and hemodynamic complications, including nephropathy toxic, anaphylaxis, and blood pressure decreases. All products were linked to serious outcomes, with non-ionic agents showing a significantly higher association with serious events (χ²(1, N=72) = 5.92, P = .015). No significant differences in age or weight were observed between ionic and non-ionic groups. Temporal trends varied by agent, with sporadic case reporting over the years; while Ultraist has shown increased trend till 2025. Conclusion: Ionic and non-ionic contrast agents used in PCI demonstrate distinct adverse event profiles. These findings show the importance of tailored patient monitoring and risk assessment when selecting contrast agents for PCI procedures.