Asian Journal of Medical Principles and Clinical Practice

Background: Rituximab (RTX) is widely used for autoimmune and haematological diseases, but infusion-related adverse drug reactions (ADRs) remain a clinically important safety concern in routine care.
Aim: This retrospective pharmacovigilance study described rituximab-associated adverse drug reactions reported at Marjan Teaching Hospital, Iraq, over a six-month period.

Methods: Data were collected from routine pharmacovigilance reports and medical records for patients with suspected rituximab-associated adverse drug reactions from January to 10^th June 2026. Extracted variables included demographic characteristics, underlying diagnosis, clinical manifestations, seriousness, management, outcomes, and causality assessment. Causality was assessed using the World Health Organization–Uppsala Monitoring Centre (WHO-UMC) system, and descriptive statistics were performed using GraphPad Prism version 10.0.

Results: Among 312 rituximab infusions, 56 patients experienced documented adverse drug reactions, yielding an incidence of 17.9% (95% CI: 13.8–22.5%). Most patients were female (96.4%), and the mean age was 42.8 years. Rheumatoid arthritis was the most common underlying diagnosis (64.3%), followed by systemic lupus erythematosus (25.0%). Shortness of breath, itching, and cough were the most frequently reported manifestations, while 50.0% of reactions were classified as serious. Most reactions were considered probable/likely by WHO-UMC assessment. All patients recovered, and rituximab was resumed at a slower infusion rate in 85.7% of cases.

Conclusion: The findings support careful infusion monitoring, prompt recognition of symptoms, and structured pharmacovigilance reporting to improve patient safety during rituximab therapy.