Analysis of adverse drug reactions in a tertiary care teaching hospital in Southern India


  • Nagaraja Prasad Sai Department of Pharmacology, Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, India



Adverse drug reactions, Adverse drug reaction monitoring centre, Causality, Pharmacovigilance


Background: Medication use has been there since time immemorial. Also, it was well known that all medications carry risk of adverse drug events. Hence regular and periodic monitoring of medications for adverse events has assumed importance. With this background pharmacovigilance has an important role to play in monitoring of adverse events to medications. Hence the present study was undertaken to analyze the pattern of adverse events reported to a tertiary care teaching hospital in Southern India (Shivamogga Institute of Medical Sciences (SIMS), Shimoga).

Methods: This study is a retrospective observational study of 150 adverse drug events reported at McGann teaching hospital, SIMS, Shimoga. The adverse events reported were analyzed for their age and gender distribution, drugs causing ADRs, organ systems affected, causality, type, severity and preventability of ADRs.

Results: Patients in age groups of 21-40 were most commonly affected by ADRs with a slight increase in male population affected. Cutaneous ADRs were most common and beta lactam antibiotics were most common drug group implicated in causing these ADRs. Probable/likely category most common WHO-UMC causality category, with type A ADRs being most common. Majority of ADRs were of moderate severity and nearly 86% of ADRs were of not preventable category.

Conclusions: Antimicrobials were most commonly involved in causation of ADRs with cutaneous ADRs being most common. Most of ADR were not preventable category, majority of ADRs were of moderate severity and causality grading was probable/likely category.


Gupta SK. Textbook of pharmacovigilance. Institute of Clinical Research (India) 1st ed. New Delhi: Jaypee Publishers Pvt Ltd; 2011:13.

Pharmacovigilance: ensuring the safe use of medicines-WHO policy perspectives on medicines, No.009; Oct 2004. Available at:

World Health Organization (WHO): safety of medicines- A guide to detecting and reporting adverse drug reactions-why health professionals need to take actions. Geneva. World Health Organization; 2002. Available at: http:// (en/d/Jh2992e/6/html).

Glossary of pharmacovigilance terms. Available at: htps://

Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.

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

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279(15):1200-05.

Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohammed M. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient episodes. PLoS One. 2009;4(2):e4439.

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.

Domecq C, Naranjo CA, Ruiz I, Busto U. Sex related variations in the frequency and characteristics of adverse drug reactions. Int J Clin Pharmacol Ther Toxicol. 1980;18(8):362-6.

Beard K. Adverse reactions as a cause of hospital admission in the aged. Drugs Aging. 1992;2(4):356-67.

Martinez ML, Garcia LM, Palop V, Ferrer JM, Rubio E, Morales-Olivas FJ. A prospective study of adverse drug reactions in hospitalized children. Br J Clin Pharmacol. 1999;47(6):681-88.

Simpson J M, Bateman D N, Rawlins M D. Using the adverse reactions register to study the effects of age and sex on adverse drug reactions. Stat Med. 1987;6(7):863-7.

Sumit Verma, Yogesh Gulati. Fundamentals of Pharmacovigilance. 1st ed. Hyderabad: Paras Medical Publishers; 2017:26.

Pharmacovigilance Programme of India (PvPI). National Coordinating Centre (NCC) - Indian Pharmacopoeia Commission (IPC), Ghaziabad. Available at: http://

Pharmacovigilance Programme of India. CDSCO. Ministry of Health and Family Welfare, Govt of India; 2010. Available at: http://

The use of WHO-UMC system for standardized case causality assessment. Available at: http:// case causality assessment.

Causality assessment algorithms and scales; 2005. Available at: http:// www.

Rawlins M D, Thompson J W. Mechanisms of adverse drug reactions. In Davies D M ed. Textbook of adverse drug reactions. Oxford. Oxford University Press; 1991: 18-45.

Hartwig SC, Seigel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229-32.

Schumock GT, Thornton JP. Focusing on preventability of adverse drug reactions. Hosp Pharm. 1992;27:538.

Rajeshreddy SGSV, Patil LV. Causality assessment and the severity of the adverse drug reactions in a tertiary care hospital: a pharmacovigilance study. Int J Basic Clin Pharmacol. 2017;6:2800-3.

Subbanna P T, Chandy S J. Role of active surveillance in improving hospital adverse drug event monitoring. Indian J Pharmacol. 2006;38(5):363-4.

Rademaker M. Do women have more adverse drug reactions? Am J Clin Dermatol. 2001;2:349-51.

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.

Segal AR, Doherty KM, Leggott J, Zlotoff B. Cutaneous reactions of drugs in children. Pediatr. 2007;120(4):1082-96.

Vijaykumar TM, Dhanaraju MD. Description of adverse drug reactions in a multi-specialty teaching hospital. Int J Integr Med. 2013;1(26):1-6.

Shareef SM, Naidu CDM, Raikar SR, Rao YV, Devika U. Development, implementation and analysis of adverse drug reaction monitoring system in a rural tertiary care teaching hospital in Narketpally, Telangana. Int J Basic Clin Pharmacol. 2015;4(4):757-60.

Sen M, Singh A, Misra M. Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital. Int J Basic Clin Pharmacol. 2018;7:303-8.




How to Cite

Sai, N. P. (2019). Analysis of adverse drug reactions in a tertiary care teaching hospital in Southern India. International Journal of Basic & Clinical Pharmacology, 8(5), 934–939.



Original Research Articles