Disproportionality Analysis of Adverse Drug Reactions across NSAID Classes Using the KAERS Database
10.24304/kjcp.2025.35.4.234
- Author:
Young Ju CHEON
1
;
Kyong Nam YE
;
Sook Hee AN
Author Information
1. ONESglobal, Inc., 64 Jandari-ro, Mapo-gu, Seoul 04031, Republic of Korea
- Publication Type:Original Article
- From:Korean Journal of Clinical Pharmacy
2025;35(4):234-242
- CountryRepublic of Korea
- Language:English
-
Abstract:
Background:Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to manage pain and inflammation but are associated with adverse events (AEs) across various organ systems. However, organ-specific AE profiles among different NSAID classesremain underexplored. This study aimed to compare AE patterns across NSAID classes using national pharmacovigilance data.
Methods:A total of 54,251 NSAID-related AE reports from 2017 to 2021 were extracted from the Korea Adverse Event ReportingSystem (KAERS). NSAIDs were classified into six groups: propionic acids, acetic acids, oxicams, fenamic acids, COX-2 inhibitors, and salicylic acids. AEs were categorized into nine System Organ Classes (SOCs) based on Medical Dictionary for Regulatory Activities (MedDRA) terminology. Disproportionality analysis was performed using Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) to identify class-specific AE signals.
Results:The most frequently reported SOCs were skin disorders (30.1%) and gastrointestinal events (24.0%). Salicylic acids showed the highest disproportionality for musculoskeletal and connective tissue disorders [ROR (95% CI)=4.18 (3.56-4.90); PRR (95% CI)=4.11 (3.51-4.81)]. Fenamic acids were notably associated with skin-related AEs [ROR (95% CI)=1.86 (1.69-2.04); PRR (95% CI)=1.47 (1.40-1.55)], while COX-2 inhibitors were linked to endocrine [ROR (95% CI)=1.91 (1.47-2.47); PRR (95% CI=1.90 (1.47-2.46)] and genitourinary disorders [ROR (95% CI)=1.92 (1.59-2.31);PRR (95% CI)=1.90 (1.58-2.28)].
Conclusion:NSAID classes demonstrate distinct AE disproportionality patterns, suggesting class-specific organ susceptibilities. These findings emphasize the need for personalized NSAID selection and further research intopredictive safety models.
