International Journal of Research in Medical Sciences | September 2023 | Vol 11 | Issue 9 Page 3293 International Journal of Research in Medical Sciences Agrawal P et al. Int J Res Med Sci. 2023 Sep;11(9):3293-3298 www.msjonline.org pISSN 2320-6071 | eISSN 2320-6012 Original Research Article Adverse drug reaction profile of anticancer agents in a tertiary care centre of rural Maharashtra: a cross-sectional study Palak Agrawal 1 , Sandeep Narwane 2 , Priyanka Gulve 1 , Prajkata Kolhe 1 *, Shreya Singhal 1 , Sonakshi Goyal 1 , Amitesh Shukla 1 INTRODUCTION The World Health Organization (WHO) defines ADR as “a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function” 1 . Adverse drug reactions (ADRs) are the one of the leading causes of repeated hospitalization and adversely affects the quality of life. 2 It has been observed that drug induced conditions lead to 5% of all hospital admissions and 10-20% of hospitalized patient develops ADRs. 3 Due to the soaring prevalence and at times potentially serious repercussion of drug therapy, ADRs may have a dramatic impact in clinical practice and on the health of society. 4 According to the Indian Council of Medical Research (ICMR), the estimated number of 1 Department of Pharmacology, Dr. Balasaheb Patil Rural Medical College, Pravara Institute of Medical Sciences Loni, Ahmedagar, Maharashtra, India 2 Department of Pharmacology, Smt. B. K. Shah Medical Institute & Research Centre, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat, India Received: 27 June 2023 Revised: 01 August 2023 Accepted: 03 August 2023 *Correspondence: Dr. Prajakta Kolhe, E-mail: prajakta.kolhe2@gmail.com Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: The present study was undertaken to analyse the clinical spectrum, pattern of ADR reported, most common suspected drugs, timing of reporting of suspected ADR, outcome, severity and causality assessment of adverse drug reactions among oncology patients reported at our ADR monitoring Centre. Methods: The descriptive cross-sectional study was carried out for two months in the oncology department of a tertiary care rural hospital. ADR reporting form Version 2.4 was used for recording information of all patients of any gender and age who were suspected cases of adverse drug reactions receiving chemotherapy. Results: Total 83 ADRs were reported within the duration of two months. The number of males and females were 21 and 62, respectively with mean age 56.9±11.6 years for males and 59.6±8.8 years for females. The age group most commonly reported with suspected ADR was 61-70 years (28.9%). Of the 83 ADR reported, the most common suspected drug was Paclitaxel (47, 56.6%). The most common indications for the use of these anticancer drugs was reported to be CA breast (43, 51.8%). Most of the ADRs (38, 45.8%) were reported immediately. On applying Naranjo’s Causality Assessment Scale, 61 and 22 ADRs fell in the category of Probable and Possible, respectively. Conclusions: The occurrence of ADR among patients on chemotherapy is high. The reported ADR were common and predictable. Hence diligent monitoring in ADR may help manage and prevent morbidity associated with anti-cancer drugs. Key words: Adverse drug reactions, Pattern, Oncology, Causality assessment DOI: https://dx.doi.org/10.18203/2320-6012.ijrms20232782