ABSTRACT
Background: Many newer drugs are approved every year for the treatment of cancers. With the limitation of clinical trials data on long-term safety, there is a need for constant monitoring of drugs use in various population. Occurrence of adverse drug reactions (ADRs) due to anticancer drugs is high due to their cytotoxic effects. Aims and Objectives: This study aims to analyze ADR reported due to anticancer drugs in relation to frequency of their occurrence, causality, severity, and preventability. Materials and Methods: This was a retrospective analysis of ADRs due to cancer chemotherapeutic agents that were spontaneously reported between January 2017 and June 2018. Data were collected from the suspected ADR notification forms submitted to ADR Monitoring Centre of the institute. Data were analyzed for type of cancers, medications used, type of ADRs, causality assessment, severity, and preventability. Results: A total of 545 ADRs were reported from 391 cases, with majority in females (65.1%). Breast was more commonly involved cancer (16.62%) and cisplatin was the common individual drug reported to cause ADRs (16.15%). The most common ADR reported was paresthesia (13.03%) followed by diarrhea (12.29%). Causality assessment revealed that most cases were probably related (61.65%). Most of the cases were moderately severe (61.28%) and most of the reported ADRs were not preventable (72.65%). Conclusion: Toxicities due to anticancer drugs can affect different organs. Most of the reported cases in this study are not preventable and of moderately severe. Appropriate use of preventive strategies helps in reduction in the occurrence and severity of ADRs.