Abstract: Objective To analyze the patterns and characteristics of adverse drug reactions (ADRs) associated with iodixanol injection, and to provide evidence for safe clinical use. Methods ADR reports submitted between January 1, 2020 and June 30, 2025 that involved iodixanol injection as the suspected drug were collected. Data on patients' gender, age, severity of ADRs, system organ classes (SOCs), routes of administration, and clinical outcomes was analyzed. Results Among the 1358 reports of ADRs, 743 (54.71%) involved males and 615 (45.29%) involved females, so the male-to-female ratio was 1.21∶1. Although the recorded ADRs were primarily expected reactions, severe ADRs made up 56.77% (771 cases). SOCs involved were mostly the skin and subcutaneous tissues (1 938 times, 89.81%). Intravenous injection was identified as the most common route of administration (765 cases, 56.33%). Most of the ADRs had an onset within 24 hours of administration, especially within 6-24 hour (319 cases, 41.37%). Furthermore, there was statistically significant difference in the proportion of severe and mild ADRs between different dosage groups (P=0.027). Conclusion ADRs induced by iodixanol injection are predominantly expected reactions and generally have favorable clinical outcomes. However, the proportion of severe ADRs remains high, which is a health concern. It is recommended that middle-aged and elderly patients as well as those with multiple underlying diseases be given special care.

Key words: Iodixanol Injection, Skin and Subcutaneous Tissue Disorders, Anaphylactic Shock, Severe Adverse Drug Reaction, Adverse Drug Reaction