Published January 23, 2026 | Version v1
Journal article Open

Role Of Pharmacovigillance in Oncology: Ensuring the Safety of Chemotherapy and Targeted Drugs

Description

Pharmacovigilance is a critical component of modern healthcare, playing a pivotal role in detecting, assessing, understanding, and preventing adverse drug reactions (ADRs). In oncology, its importance is heightened due to the complex and often toxic nature of anticancer therapies. Conventional chemotherapeutic agents, while effective, are non-selective and can damage healthy cells, causing systemic toxicities such as myelosuppression, cardiotoxicity, nephrotoxicity, and gastrointestinal disturbances. Targeted therapies, designed to act on specific molecular pathways, offer improved efficacy and reduced off-target effects but present unique safety challenges, including dermatologic, hepatic, cardiovascular, and hematologic toxicities. Effective pharmacovigilance systems facilitate early detection of ADRs, support regulatory decision-making, guide clinical practice, and enhance patient safety. This review provides an overview of pharmacovigilance in oncology, focusing on the safety monitoring of chemotherapy and targeted drugs, regulatory frameworks, reporting mechanisms, challenges in ADR detection, and future directions, including integration of digital tools, pharmacogenomics, and real-world data to optimize drug safety. Proactive pharmacovigilance is essential to ensure safe and effective cancer therapy, improving clinical outcomes and patient quality of life.

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