Background:Antibioticsare one of the most commonly used drugs in hospitalised patients and are sometimes associated with significant safety concerns. However, there is still insufficient data about the incidence of adverse drug reactions(ADR) especially in case of injectable antibiotics. This study was done to assess the severity and pattern of different types of adverse drug reaction that occurs with commonly used injectable antibiotics. Method: A retrospective cross-sectional study was done at Pharmacovigilance centre RIMS utilizing data from January 2018 till December 2019. Result: A total of 146patients who presented with antibiotic associated ADR reported during the study period were included in this study. Incidence was higher in males (90) as compared to females (56). The most common injectableantibiotic responsible for ADR was found to be the cephalosporin group (42.6%). A total of 178 different ADRs were observed among 146 patients, out of which the dermatological system (27.4%) was the most commonly affected system. On evaluation of WHO-UMC causality assessment of ADRs, majority were found to be possible (64.4%). Conclusion:Injectable antibioticsare one of the most importantdrugs used for treatment of various clinical conditions and the sheer magnitude of their usage among hospitalised patientsrequires special monitoring especially with respect to the adverse reactions they can cause.A more active pharmacovigilance is needed for better understanding of the types of injectable antibiotics associated ADRs. Active monitoring can also help promoterational use of these important life saving drugs.

Introduction: Anticancer drugs account to high susceptibility towards Adverse Drug Reactions (ADRs) due to their narrow therapeutic window and increased toxicity, which makes pharmacovigilance studies essential. Aim: To determine the nature and severity of ADRs in cancer patients based on the reports received from the Department of Radiation Oncology to the Pharmacovigilance centre of a tertiary care hospital. Materials and Methods: A retrospective, descriptive study was conducted in the Regional Institute of Medical Sciences (RIMS), Imphal, Manipur, India on the patients who developed ADRs due to anticancer drugs during the period from January 2018 to December 2020. These ADRs were assessed for causality using World Health Organisation- Uppsala Monitoring Centre (WHO-UMC) criteria. The data was analysed using Statistical Package for the Social Sciences (SPSS) version 21.0 and frequencies and percentages were determined for each variable. Results: A total of 913 ADRs were reported from 334 patients. Total 62.57% females developed ADRs and age group of 51-60 years (31.14%) were affected the most. Bronchogenic carcinoma (20.9%) was found to be the most common cancer and haematological system (31.11%) was mostly affected. Most common ADRs observed were alopecia (16.32%) followed by anorexia and anaemia. Carboplatin (23.21%) followed by Cisplatin, Paclitaxel, Docetaxel were the most common drugs causing different ADRs. On causality assessment, as per WHO-UMC criteria 67.25% ADRs were ‘probable’ and 32.75% were ‘possible’. Severity assessment using modified Hartwig and Siegel scale showed 56.41% ADRs as mild, 41.95% moderate and 1.64% severe reaction. Preventability assessment using Schumock-Thornton scale showed 44.69% ADRs were ‘not preventable’ whereas 41.62% ADRs were ‘definitely preventable’ and 13.69% were ‘probably preventable’. Conclusion: The use of anticancer drugs is associated with various adverse effects. However, early detection of the ADRs may help to modify the doses or the drug regimen to minimise the adverse effects.