Safety profile of linezolid in the elderly: National database analysis

Background Linezolid 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 aim To disclose the structure of adverse drug reactions (ADRs) associated with linezolid in patients ≥60 years. Materials and methods Retrospective analysis of spontaneous reports (SRs) from the Russian Pharmacovigilance database (April 2019–December 2024). Results SRs 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%, n = 68), gastrointestinal disorders (17.6%, n = 49), investigations (11.1%, n = 31), skin and subcutaneous tissue disorders (9.7%, n = 27), and general disorders and administration site conditions (6.1%, n = 17). Top-5 preferred terms (PTs) were thrombocytopenia (7.9%, n = 22), anemia (7.2%, n = 20), nausea 4.3% ( n = 12), diarrhea (3.6%, n = 10), vomiting (3.6%, n = 10), and leukopenia (3.6%, n = 10). Conclusions Linezolid-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.