Objective To analyze the adverse events(AEs)associated with linezolid in tuberculosis treatment reported in the FDA Adverse Event Reporting System(FAERS)database,assess its safety profile,and provide scientific evidence for ra-tional clinical use.Methods Reports of adverse events related to linezolid in tuberculosis treatment from Q1 2016 to Q1 2024 were extracted.The data were cleaned and pre-processed,and signal detection was performed using the Reporting Odds Ratio(ROR)and Information Component(IC)methods.Results A total of 1,135 linezolid-related AEs were identified,with the most common types being hospitalization(18.46％)and death(10.99％).The Results indicated that linezolid AEs primarily involved disorders of the blood and lymphatic system,as well as liver and biliary system diseases.Common adverse reactions in-cluded anemia,peripheral neuropathy,and optic neuropathy.Additionally,some adverse reaction signals not mentioned in the prescribing information were identified,such as polyneuropathy(ROR=75.25,IC025=5.8),toxic optic neuropathy(ROR=776.95,IC025=8.86),and hearing loss(ROR=14.66,IC025=3.26).Conclusion This study suggests that linezolid may be associated with some serious adverse reactions in tuberculosis treatment.It is recommended that patients on long-term linezolid therapy undergo regular neurological,ophthalmological,and auditory assessments to provide a more adequate basis for rational clinical use.
维普
万方数据
