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Background and Importance Graft-versus-host disease(GvHD) is a serious complication after allogeneic haematopoietic stem cell transplantation(allo-HSCT). Ruxolitinib is effective in refractory cases, but real-world safety data are limited.Aim and Objectives To evaluate the safety of ruxolitinib in patients with acute GvHD and chronic GvHD refractory to corticosteroids after allo-HSCT.Material and Methods Observational, descriptive, retrospective study, (July 2017–August 2025) including patients authorised to receive ruxolitinib by the Committee for Rational Use of Medicines and Medical Devices.Demographic, clinical (underlying disease, donor type, conditioning regimen, GvHD type), and treatment-related (dose, start/end dates, adverse drug reaction [ADR], grade, dose adjustments, reasons for discontinuation, mortality) variables were analysed. Data were obtained from electronic medical records and the software for management of oncology patients. ADRs were graded according to Common Terminology Criteria for Adverse Events v5.0.Results Thirty-six patients were included (61% male, median age 52 years). The most common underlying diseases were acute myeloid leukaemia (36.1%) and acute lymphoblastic leukaemia (16.7%). A total of 47.2% received a related donor transplant (70.6% HLA-identical) and 31% of patients underwent myeloablative conditioning. A total of 41.7% had aGvHD and 58.3% had cGvHD.Of the 36 patients included, two were excluded for not starting treatment.The initial dose was 5 mg every 12 h in 41.2% of patients; median treatment duration was 15.7 months (95% CI:6.83–50.8).ADRs were observed in 20 patients (58.8%), most frequently anaemia (n=10), thrombocytopenia (n=7), neutropenia (n=6), and renal impairment (RI)(n=4).Thirty-four ADRs were identified; 20.6% required dose reduction, mainly for RI, liver test abnormalities, and thrombocytopenia.Three patients required temporary treatment discontinuation due to cytopenias and renal impairment.Toxicity led to permanent discontinuation in 8 patients (23.5%): RI(n=2), anaemia (n=3), neutropenia (n=2), headache(n=1) and thrombocytopenia (1).Three patients experienced grade 2–3 ADRs (two with thrombocytopenia, one with thrombocytopenia and anaemia), and two patients developed grade 4 neutropenia.Eleven deaths were recorded, all due to transplant-related complications, and none drug-related. Among them, seven patients had aGvHD, four cGvHD.Conclusion and Relevance Ruxolitinib showed a high incidence of ADRs in real-world practice, affecting more than half of patients.This affected treatment continuity, causing dose reductions and permanent discontinuations in nearly a quarter of patients. Predominant toxicity was hematologic (anaemia, thrombocytopenia, neutropenia).Most adverse events were manageable, with some grade 3–4 ADRs, but no drug-related deaths occurred.Conflict of Interest No conflict of interest