• Gajanan P. Kulkarni Department of Pharmacology, Bidar Institute of Medical Sciences (BRIMS), Bidar, Karnataka
  • Lokesh V. Patil Department of Pharmacology, Bidar Institute of Medical Sciences (BRIMS), Bidar, Karnataka


Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.

Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.

Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.

Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

Keywords: Adverse drug reaction, Pharmacovigilance, Causality assessment, Serious reactions


1. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients, excess length of stay, extra costs and attributable mortality. JAMA 1997;227:301-6.
2. World Health Organization. Safety of Medicines. A guide to detecting and reporting adverse drug reactions. Geneva, Switzerland: World Health Organization. HO/EDM/QSM/2002; 2002.
3. Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002;24:46-54.
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. JAMA 1995;274:29-34.
5. Lexchin J. Is there a role for spontaneous reporting of adverse drug reactions? CMA J 2006;174:191-2.
6. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239‑45.
7. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229‑32.
8. Bhabhor PH, Patel KP, Vohata R, Patel PB, Desai N. Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases. Int J Basic Clin Pharmacol 2014;3:1078-85.
9. Ramesh M, Pandit J, Parthasarthi G. Adverse drug reactions in a south Indian hospital-their severity and cost involved. Pharmacoepidemiol Drug Saf 2003;37:687-92.
10. Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm 1993;28:1199-204.
11. Hettihewa LM, Sirisena B. Casualty assessment and the severity of the adverse drug reactions (adr) actively detected in hospital in patients in tertiary care hospital Sri Lanka: a Prospective observational survey. Asian J Res Biol Pharm Sci 2014;2:1-10.
12. Johnston PE, France DJ, Byrne DW, Murffy HJ, Lee B, Stiles RA, et al. Assessment of adverse drug events among patients in a tertiary care medical centre. Am J Health Syst Pharm 2006;63:2218-27.
13. 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;59:1-4.
14. Rajakannan T, Mallaya S, Lakshminarasu M, Rajendra SD. Intensive monitoring of Adverse drug reactions in a south Indian tertiary care hospital. J Clin Pharmacol 2012;52:559-65.
15. Chan AL, Lee HY, Ho CH, Cham TM, Lin SJ. Cost evaluation of adverse drug reactions in hospitalized patients in Taiwan: a prospective, descriptive, observational study. Curr Ther Res Clin Exp 2008;69:118‑29.
241 Views | 439 Downloads
How to Cite
Kulkarni, G., and L. Patil. “ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY”. International Journal of Current Pharmaceutical Research, Vol. 10, no. 1, Jan. 2018, pp. 23-25, doi:10.22159/ijcpr.2018v10i1.24403.
Original Article(s)