Descriptive study of adverse drug reaction patterns with antineoplastic and immunomodulating agents reported to the National Pharmacovigilance Centre in Saudi Arabia (2018–2020): A retrospective analysis

Adverse drug reactions (ADR) with antineoplastic agents are a common problem faced by patients and impose an economic burden on the healthcare system. The Saudi Food and Drug Authority (SFDA) collects, monitors, and analyses ADR reports from all healthcare organizations around the kingdom to understand the pattern of ADRs to find was to prevent it. The aim of this study is to investigate the pattern of reported ADRs with antineoplastic and immunomodulating agents. This was a retrospective secondary data evaluation of ADR reports submitted to the SFDA between January 2018 and December 2020. Descriptive statistics were performed, and results were presented as frequencies and percentages. Ethical approval was obtained from the research center of the SFDA. 3457 reports involved ADRs with antineoplastic and immunomodulating agents. The ratio of male to female was approximately 60:40 and adults experienced most of the ADRs (86.4%). Most of the ADRs were reported by healthcare providers in hospitals (94.3%, 3261). The majority of ADRs were found with infliximab (14.3%, 496), followed by rituximab (6.7%, 233). The majority of ADRs were serious (67.3%, 400) and one-third resulted in no harm (33%, 194) and the highest percentage of ADRs that were serious required intervention to prevent permanent impairment/damage (26.4%, 157). ADRs with antineoplastic agents are common. Increasing the knowledge of healthcare providers about these ADRs as well as motivating them to report might increase ADR reporting and help us understand ADRs causes and ways to mitigate it.