Risk Assessment of Linezolid-Associated Neurological Adverse Drug Reactions Based on the Food and Drug Administration Adverse Event Reporting System Database.

Objective: To conduct data mining and analysis on neurological adverse drug reactions (ADRs), defined as any unwanted neurological effects caused by the use of linezolid, affecting both the central and peripheral nervous systems. This study also aims to investigate potential drug-drug interactions that may increase the risk of these ADRs when linezolid is used in combination with other medications. The findings aim to provide guidance for the safe clinical use of linezolid. Methods: Data from the US Food and Drug Administration Adverse Event Reporting System between 1 July 2014 and 30 June 2024 were analysed to identify linezolid-related neurological ADRs. The Ω shrinkage measure was used to detect drugs associated with an elevated risk of neurological ADRs. Results: A total of 8521 reports of linezolid-related ADRs were retrieved, of which 20.12% (1720 cases) involved neurological ADRs. Forty-five signals of neurological ADRs were detected, with serotonin syndrome (436 cases, reporting odds ratio [ROR] = 43.66, representing 25.35%) and peripheral neuropathy (413 cases, ROR = 7.88, representing 24.01%) being the most prevalent. Additionally, 23 previously undocumented ADR signals and 21 drugs associated with an increased risk of neurological ADRs (Ω 025 > 0) were identified. Conclusion: This study highlights the need for careful monitoring of neurological ADRs associated with linezolid, vigilance regarding previously undocumented ADRs and the prudent management of concomitant medications. These findings provide essential guidance for the safe clinical use of linezolid.