Safety profile of linezolid in the elderly: National database analysis

BackgroundLinezolid is one of the most used antibacterials to treat resistant gram-positive infections, though its use may result in a number of toxic effects, especially in the older adults. There is lack of data derived from the real-world studies regarding safety of linezolid in the elderly.The aimTo disclose the structure of adverse drug reactions (ADRs) associated with linezolid in patients ≥60 years.Materials and methodsRetrospective analysis of spontaneous reports (SRs) from the Russian Pharmacovigilance database (April 2019-December 2024).ResultsSRs of patients ≥60 years accounted up to 19.9% in the total structure of SRs. Top-5 system-organ classes (SOCs) were blood and lymphatic system disorders (24.4%, <i>n</i> = 68), gastrointestinal disorders (17.6%, <i>n</i> = 49), investigations (11.1%, <i>n</i> = 31), skin and subcutaneous tissue disorders (9.7%, n = 27), and general disorders and administration site conditions (6.1%, <i>n</i> = 17). Top-5 preferred terms (PTs) were thrombocytopenia (7.9%, <i>n</i> = 22), anemia (7.2%, <i>n</i> = 20), nausea 4.3% (<i>n</i> = 12), diarrhea (3.6%, <i>n</i> = 10), vomiting (3.6%, <i>n</i> = 10), and leukopenia (3.6%, <i>n</i> = 10).ConclusionsLinezolid-induced myelosuppression was identified as the most significant safety concern in patients ≥60 years, underscoring the necessity for careful laboratory and clinical monitoring in this population.