Background: Advancement in modern era of Chemotherapy has brought significant survival benefits to patients. However, ADR are very common, with considerable economic and clinical implication leading to disability and even death. Documentations of ADRs associated with cancer chemotherapy and analysis of their severity and preventability would create awareness among health care providers and prevent recurrence in subsequent chemotherapeutic cycles. 1680-1700 newly diagnosed cancer patients are registered every year for Chemotherapy in this tertiary care hospital. Breast, Ovarian, lung, hematological cancers are the commonest. Most of the adverse events were non-serious like vomiting, headache, abdominal pain, itching, dyspepsia, anemia, vertigo and oral mucositis. Also, serious events like raised urea, serum creatinine, elevated liver enzymes, hyperbilirubinaemia, hematemesis, hemoptysis, thrombocytopenia and pancytopenia were also reported. This study will help to monitor the adverse events caused by the anti-cancer drugs and subsequent management and prevention of adverse events by symptomatic treatment without disturbing the cycle of chemotherapy.

Materials and Methods: All in-patients newly registered for cancer chemotherapy for whom ADR were reported by Individual Case Safety Reports (ICSR) were retrospectively analyzed from January 2018 to December 2018 .The causality Assessment was carried out by Causality Assessment Committee (CAC) using WHO Causality Assessment Scale and reported as “certain”, “probable” and “possible. The outcomes of reactions were reported as Recovered, Recovering, Not recovered, Fatal, Recovered with sequelae, and Unknown as per guidance document for spontaneous reporting, Indian Pharmacopoeia Commission-2014.

Results: Out of 72 reported ADRS 35 were male patients and 37 Female patients. Non serious reactions of 60 ICSR’s and 12 were serious reactions. Outcome of reactions was recovering/ recovered from the ADR. Most of the ICSR’s were reported as Probable as per WHO-UMC Causality assessment scale. The drugs like Cisplatin, Paclitaxel, Doxorubicin, Docetaxel, Imatinib, Oxaliplatin, Vincristine and Zoledronic acid were reported for both serious and non-serious adverse events.

Conclusion: Among 72 reported ICSR’s majority are non-serious reactions and treated symptomatically without breaking the cycle of chemotherapy. Serious ADR’s like nephrotoxicity (or) liver toxicity were monitored periodically and the dose adjusted or the cycle was stopped to prevent further catastrophe. ADR reports will help in monitoring drug safety in oncology and prevent the sufferings of patient.