Exploring the dark side of diagnostic dyes with a focus on Indocyanine green’s adverse reactions

Indocyanine green (ICG) is a diagnostic dye commonly used in medical imaging and liver function monitoring. Given its widespread use, there is a need for detailed evaluations of its adverse drug reactions in real-world settings. As the comprehensive overview of its safety profile is very limited, this study aimed to analyze the adverse events (AEs) associated with ICG using data from the Food and Drug Administration Adverse Event Reporting System (FAERS). Data between 2004Q1 and 2023Q4 were extracted from the FAERS database. Signal detection was performed using various disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multiitem gamma Poisson shrinker. During the study period, a total of 62 ICG-related AEs were reported in the FAERS database. Significant clinical adverse reactions included anaphylactic shock (ROR: 92.10, 95% confidence interval (CI): 37.71-224.96), procedural hypotension (ROR: 1397.27, 95% CI: 443.31-4404.08), and urticaria (ROR: 10.88, 95% CI: 4.02-29.42). This study provides valuable insights into the safety profile of ICG, highlighting the need for further monitoring to ensure its safe clinical use in clinical practice. Ongoing pharmacovigilance and large-scale studies are warranted to fully understand the potential risks associated with ICG.