Pharmacovigilance in Oncology: A Systematic Review on Monitoring the Safety and Adverse Drug Reactions of Anticancer Therapies

Background: Cancer remains a major global health challenge, with cases projected to reach 22.2 million annually by 2030. In India, over 1.46 million new cases were reported in 2022. Although multimodal treatments such as chemotherapy, targeted therapy, and immunotherapy have improved survival, they are often associated with significant adverse drug reactions (ADRs), necessitating strong pharmacovigilance systems. Objective: To review cancer epidemiology, evaluate treatment-related ADR patterns, and highlight the importance of pharmacovigilance in oncology. Methods: A comprehensive review of oncological safety data was conducted, focusing on incidence, patient demographics, ADR patterns, causality, severity, and reporting practices among healthcare professionals. Results : Cancer incidence is slightly higher in males, but ADRs are more frequently reported in females (66.4%) and patients over 50 years. Breast and ovarian cancers are most commonly associated with ADRs. Most reactions occur during drug infusion, especially with platinum compounds and taxanes. Skin and respiratory systems are frequently affected. The majority of ADRs are moderate and classified as “probable.” Nurses contribute most ADR reports, while physician reporting remains minimal. Conclusion: Underreporting of ADRs is a major challenge in oncology pharmacovigilance. Improving multidisciplinary reporting, increasing awareness, and integrating AI and electronic health records are essential to enhance drug safety and patient outcomes.