Ketorolac tromethamine is a potent nonsteroidal anti-inflammatory drug commonly used to treat moderate-to-severe pain, especially in the context of postoperative and acute injury. However, real-world studies on the adverse events (AEs) associated with ketorolac tromethamine remain limited. A disproportionality analysis was performed using data from the FDA Adverse Event Reporting System between January 2004 and September 2024 to evaluate the safety profile of ketorolac tromethamine by analyzing the demographic characteristics and timing of AEs. A total of 3655 AEs associated with ketorolac tromethamine were identified, revealing 167 significantly preferred terms and 2 notable system organ classes. Commonly reported AEs included drug hypersensitivity, hypersensitivity reactions, and eye irritation. Subgroup analyses indicated that eye disorders and immune system disorders were significant across gender, age, and weight categories. Weibull analysis showed that the occurrence of AEs decreases over time, suggesting early failure. Sensitivity analyses identified eye and immune system disorders as the main safety concerns for ketorolac tromethamine, with persistent issues in both categories after ophthalmic use and immune disorders after systemic use. This study confirmed known AEs associated with ketorolac tromethamine while identifying additional risks, particularly those related to eye and immune system disorders. Continued monitoring of these AEs in clinical settings is essential to ensure patient safety.
Keywords: adverse drug events; ketorolac tromethamine; pharmacovigilance; real-world evidence; signal detection.
Copyright © 2026 the Author(s). Published by Wolters Kluwer Health, Inc.