The pattern of reported adverse drug reactions with reference to specific drug class and organ system

Margaret Viola Jillapegu, Dhishan Sai Kumboju Srinivasulu, Umamaheswara Raju Sarikonda, Raghunatha Rao Ponnaluri, Jahnavi Tiruveedhula


Background: Adverse drug reactions (ADRs) represent a major public health problem. The overall ADR rate is estimated to be 6.5 and 28% of these are preventable.ADR incidence in Indian population ranges between 1.8-25% with 8% resulting in hospitalization. Hence, the present study was undertaken to study the pattern of reported adverse drug reactions with reference to specific drug class and organ system in a tertiary care hospital.

Methods: A cross-sectional retrospective study was carried to analyse the ADRs reported over a period of one year (January-December 2019). Individual case safety reports (ICSRs) of all patients of suspected adverse drug reactions seen in various out-patient departments and admitted in the wards of the hospital were included in the study. The ICSRs were analysed for patient demography, causality, severity and with reference to specific drug class and organ system.

Results: Among 382 reported ADRs, 27.2% of the ADRs were reported as serious. The most common therapeutic class of drugs causing ADRs where Antimicrobial agents (36.07%). The skin is the most common affected organ system (25.39%).

Conclusions: A coordinated system of identifying the ADRs early in the course of treatment and recognizing the preventable ADRs is required by the health care system. The coordination of prescribing physicians and pharmacovigilance personnel can produce better trend of reporting the ADRs.


ADRs, Pharmacovigilance, WHO causality assessment, Seriousness criteria, Therapeutic class of drugs, Specific organ system

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Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacotherap. 2013;4:73-7.

Alsbou M, Alzubiedi S, Alzobi H, Samhadanah NA, Alsaraireh Y, Alsaraireh Y et al. Adverse drug reactions experience in a teaching hospital in Jordan. Int J Clin Pharmacy. 2015;37(6):1188-93.

World Health Organization. Safety of Medicines-A Guide to Detecting and Reporting Adverse Drug Reactions-Why Health Professionals Need to Take Actions. World Health Organization, Geneva; 2002. Available at: safety/esd_safety.pdf. Accessed on 25 July 2020.

Lihite RJ, Lahkar M, Das S, Hazarika D, Kotni M, Maqbool M et al. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alexandria J Med. 2017;53(2):151-6.

Raut LA, Patel P, Patel C, Pawar A. Preventability, predictability and seriousness of adverse drug reactions amongst medicine inpatients in a teaching hospital: a prospective observational study. Int J Chem Pharmac Sci. 2012;1(3):1293-9.

Gaur S, Paramjeet S, Srivastava B, Bhardwaj R, Ahuja S, Gunjita B. Evaluation of Adverse Drug Reactions in teaching hospital in Kumoun Region. J Med Sci Clin Res. 2016;4(8):12139-45.

Srinivasan R, Ramya G. Adverse drug reaction causality assessment. Int J Res Pharmacy Chem. 2011;1(3):606-11.

Doshi MS, Patel PP, Shah SP, Dikshit RK. Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital. J Pharmacol Pharmacotherap. 2012;3(4):308-13.

Sharma PK, Misra AK, Gupta N, Khera D, Gupta A, Khera P et al. Pediatric pharmacovigilance in an institute of national importance: Journey has just begun. Indian J Pharmacol. 2017;49(5):390-5.

Mann RD, Andrews EB. Introduction. In: Mann RD, Andrews EB, eds. Pharmacovigilance. 2nd Edition. England: John Wiley and Sons, Ltd. 2007:3-11.

Brown JS, Landry FJ. Recognizing, reporting, and reducing adverse drug reactions. Southern Med J. 2001;94(4):370-3.

Shrivastava M, Uchit G, Chakravarti A, Joshi G, Mahatme M, Chaudhari H. Adverse drug reactions reported in Indira Gandhi Government Medical College and Hospital, Nagpur. J Assoc Physicians India. 2011;59:296-9.

Guidance Document for Spontaneous Adverse Drug Reaction Reporting Version: 1.0. Indian Pharmacopoeia Commission, National Coordination Centre-Pharmacovigilance Programme of India, Ministry of Health and Family Welfare, Governemnt of India. 2014-12.

Medical Dictionary for Regulatory Activities Maintance and Support Services Organization (MedDRA MSSO). Available from URL: http:// Accessed 17 Jun 2010.

Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. 2006;54(3):226-33.

Belhekar MN et al. A prospective study on causality, severity and preventability assessment of adverse drug reactions in a tertiary care hospital in India. Int J Basic Clin Pharmacol. 2019;8(1):104-10.

David P, Devinder Mohan T. Adverse cutaneous drug reactions: Clinical pattern and causative agents in a tertiary care center in South India. Indian J Dermatol Venereol Leprol. 2004;70(1):20.

Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital-their severity and cost involved. Pharmacoepidemiol Drug Safety. 2003;12(8):687-92.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. British J Clin Pharmacol. 2008;65(2):210-6.

Rao PG, Archana B, Jose J. Implementation and results of an adverse drug reaction reporting programme at an Indian teaching hospital. Indian J Pharmacol. 2006;38(4):293.

Singh H, Dulhani N, Kumar BN, Singh P, Tewari P, Nayak K. A pharmacovigilance study in medicine department of tertiary care hospital in Chhattisgarh (Jagdalpur), India. J Young Pharmacists. 2010;2(1):95-100.

Bhuvaneshwari E, Chakradhar T, Sravani M. Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India. Int J Basic Clin Pharmacol. 2019;8(11):2541-7.

Adhikari A, Bhattacharjee N, Bhattacharya S, Indu R, Ray M. Evaluation of adverse drug reports from a tertiary care hospital of Kolkata, West Bengal, India. J Young Pharmacists. 2017;9(3):311-4.

Routledge P, O’Mahony M, Woodhouse K. Adverse drug reactions in elderly patients. Bri J Clin Pharmacol. 2004;57:121-6.

Davies EC, Green CF, Mottram DR, Green CF. Adverse drug reactions in hospitals: a narrative review. Curr Drug Safety. 2007;2(1):79-87.

Venkatasubbaiah MP, Reddy D, Satyanarayana SV. Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alexandria J Med. 2018;54(4):597-603.

Sneha G, Sowmya N, Goka P, Rao N, Prasanthi N, Nadendia R et al. An observational prospective study on prevalence and monitoring of adverse drug reactions in tertiary care teaching hospital. Bri J Pharmac Res. 2016;11:1-9.

Hemavathy G, Rathinam J, Preethi A, Divakar R. A retrospective analysis of adverse drug reactions reported at a tertiary care hospital in South India. Int J Basic Cli Pharmacol. 2018;7:1257-62.

Badyal DK, Kanish B, Gulrez G. Causality assessment and pattern of adverse drug reactions in a tertiary care hospital. Int J Basic Clin Pharmacol. 2018;7:210-4.

Sood A, Sood V, Prajapati H, Sharma A, Bansal R, Mahajan V. Pharmacovigilance analysis in a rural tertiary care hospital in North India: a retrospective study. Int J Basic Clin Pharmacol. 2016;5:1425-31.

Akshaya SS, Srihitha. An Epidemiological Study on Adverse Drug Reactions in Indian Population: Meta-Analysis. Int J Pharmac Clin Res. 2017;9(10):654-9.

Prajapati K, Desai M, Shah S, Panchal J, Kapadia J, Dikshit R. An analysis of serious adverse drug reactions at a tertiary care teaching hospital. Perspectives Clin Res. 2016;7:181-6.

Kanjanarat P, Winetrstein AG, Johns TE, Hatton RC. Nature of preventable adverse drug events in hospitals: a literature review. Am J Health-System Pharmacy. 2003;60(17):1750-59.

Lakshmanan MC, Hershey Co, Brealan D. Hospital admission caused by iatrogenic disease. Arch Internal Med. 1986;146(10):1931-4.

Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D et al. Incidence of adverse drug events and potential adverse drug events. Adverse drug event prevention study group. J Am Med Asso. 1995;274:29-34.

Davies E, Green C, Taylor S, Williamson P, Mottram D, Pirmohamed M. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. Public Library Sci One. 2009;4:e4439.

Padmaja U, Adhikari P, Pereira P. A Prospective Analysis of Adverse Drug Reactions in a South Indian Hospital. Online J Health Allied Sci. 2009;8(3):12.

Sriram S, Ghasemi A, Ramasamy R, Devi M, Balasubramanian R, Ravi TK et al. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. J Res Med Sci. 2011;16(1):16-25.