A disproportionality analysis of hydrocortisone-related adverse events: a real-world pharmacovigilance study using the FAERS database.

Abstract

Background: This study aims to systematically evaluate adverse events (AEs) associated with hydrocortisone through the FDA Adverse Event Reporting System (FAERS) database.

Research designs: AE reports associated with hydrocortisone from Q1 2014 to Q4 2023 were extracted from the FAERS database. Multiple disproportionality analysis techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), were employed for signal detection. In addition, we also analyzed the time to onset of AEs.

Results: Analysis of 7,532 hydrocortisone-associated AEs from the FAERS database revealed significant signals across multiple system organ classes. The strongest associations were found in endocrine disorders (ROR: 13.39), ear and labyrinth disorders (ROR: 3.05), and immune system disorders (ROR: 2.17). Additionally, the study uncovered unexpected AEs such as splenic peliosis and lymphoid tissue hypoplasia. 63.9% of the AEs occurred within 7 days of treatment.

Conclusions: Based on disproportionality analysis of FAERS data, this study provides new insights into the safety of hydrocortisone in the real-world setting. Future prospective studies should be conducted to validate the findings of this investigation.