ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Inflammation Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1598433
Signal mining and analysis of sepsis-related adverse events in patients using immunosuppressive drugs based on the FDA Adverse Event Reporting System(FAERS)database
Provisionally accepted
- Department of Critical Care Medicine, Nanjing First hospital, Nanjing Medical University, Nanjing, China
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Background: Sepsis, as a syndrome of organ dysfunction triggered by a dysregulated host response to infection, has an enormous disease burden. However, comprehensive clinical trials of druginduced sepsis are lacking. Given the increasing use of immunosuppressive drugs worldwide, there is a need to understand the true extent of the adverse effects of sepsis associated with immunosuppressive drugs.Methods: This pharmacovigilance study was based on the analysis of reports from the FDA Adverse Event Reporting System (FAERS) for the period Q4 2003 to Q3 2024. Analyses were compared using proportional reporting ratios (PRR), reporting advantage ratios (ROR), Bayesian confidence propagation neural network (BCPN) and multi-item gamma Poisson shrinkage (MGPS).Results: A total of 117,147 reports of adverse events (AEs) to sepsis were identified and, except for reports of unspecified nature, there was no significant gender difference between 44.54% (n = 52,179) of females and 43.45% (n = 50,906) of males. The most commonly reported country was the United States (39.87%). The top five drugs were prednisone, methotrexate, dexamethasone, cyclophosphamide and prednisolone, all immunosuppressants.A variety of drugs can cause sepsis AEs, with immunosuppressants being more common, and it should be noted that the incidence and signal strength of sepsis-related adverse reactions vary with the specific drug. In clinical practice, the selection of appropriate drugs for sepsis intervention is crucial, and monitoring for adverse reactions should be tailored to the specific situation and characteristics of the patient.
Keywords: Adverse event, Food and Drug Administration, immunosuppressive drugs, Real world, Sepsis
Received: 23 Mar 2025; Accepted: 14 Apr 2025.
Copyright: © 2025 Zhou, Chen, Xu and Sun. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
XueHui Zhou, Department of Critical Care Medicine, Nanjing First hospital, Nanjing Medical University, Nanjing, China
Jia-Kui Sun, Department of Critical Care Medicine, Nanjing First hospital, Nanjing Medical University, Nanjing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.