Abstract
BACKGROUND: Toradol, a potent nonsteroidal anti-inflammatory drug, is widely used for perioperative analgesia, especially in orthopedic surgeries. Postmarketing surveillance is crucial due to its extensive clinical application. This study aimed to investigate adverse events (AEs) associated with Toradol using the FDA Adverse Event Reporting System (FAERS), analyze the association strengths of key AEs, and provide clinical references. METHOD: FAERS data from 2004 Q1 to 2017 Q4 were analyzed, including reports where Toradol was the primary suspect drug. Disproportionality analyses were conducted using ROR, PRR, BCPNN, and EBGM algorithms to detect safety signals. RESULT: Among 377 eligible reports, key AEs included immune system disorders (anaphylactic reaction, ROR = 16.28), renal and urinary disorders (oliguria, ROR = 25.57), and gastrointestinal disorders (erosive duodenitis, ROR = 231.08). Notably, 29.86% of reports were from consumers, with a lower proportion from healthcare professionals. Most AEs (73.10%) occurred within 7 days of administration; rare but severe events, including deafness and cardiorespiratory arrest, were also identified. CONCLUSION: Our findings, derived from hypothesis-generating signal detection analyses, provide real-world safety data on Toradol, highlighting high-risk AEs and reporting biases. Enhanced vigilance and monitoring, especially in high-risk populations, are imperative. However, these signals require confirmation through prospective, controlled studies to establish causality.