Abstract
OBJECTIVE: This study aimed to analyze the pattern, severity, and outcomes of adverse drug reactions (ADRs) associated with rituximab use reported to a regional pharmacovigilance center in Kerala, India. METHODS: This retrospective study analyzed rituximab-associated ADRs reported from 2017 to 2023. ADRs were assessed using the WHO-UMC criteria for causality and the Modified Hartwig Siegel Scale for severity. RESULTS: A total of 74 patients reported ADRs, with 49 being female. The majority (27 patients) were in the 51- to 60-year age group. Malignancies accounted for 58 cases of rituximab use. Most ADRs (69 cases) occurred with the first dose, with infusion reactions being the most common. Causality assessment revealed that 48 ADRs were probably related to rituximab. Severity analysis using the Modified Hartwig Siegel Scale showed that 67 ADRs were level two (mild), while two were level seven (severe). The majority of patients (72) recovered. However, rituximab-induced lung disease, observed in two cases, was associated with higher mortality. CONCLUSION: Rituximab demonstrated an acceptable safety profile, with most ADRs being non-serious and manageable. The high recovery rate reflects effective ADR management. However, the potential for serious complications, particularly rituximab-induced lung disease, highlights the need for vigilant monitoring, especially during the first infusions. These findings enhance understanding of rituximab's real-world safety profile and underscore the importance of standardized protocols for ADR mitigation.