What question did this study set out to answer?

To evaluate the safety profile of ketorolac tromethamine by analyzing adverse events in a real-world setting.

January 21, 2026Medicine0 citationsOpen Access

A real-world signal detection analysis uncovering the safety profile of ketorolac tromethamine

YRyuanyuan rongQingdao University HWHaijiao WangHebei Medical University SZShasha ZhangHebei Medical University

Key Points

To evaluate the safety profile of ketorolac tromethamine by analyzing adverse events in a real-world setting.
Conducted disproportionality analysis using FDA Adverse Event Reporting System data.
Analyzed data from January 2004 to September 2024.
Identified 3655 adverse events associated with ketorolac tromethamine.
Performed subgroup analyses by gender, age, and weight categories.
Utilized Weibull analysis to assess timing of adverse events.
Identified 167 significantly preferred terms and 2 notable system organ classes related to adverse events.
Commonly reported adverse events included drug hypersensitivity and eye irritation.
Eye and immune system disorders were significant across various demographic categories.
Weibull analysis indicated that adverse event occurrence decreases over time, suggesting early failure.
Confirmed known adverse events and revealed additional risks, particularly for eye and immune system disorders.

Abstract

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.

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