A retrospective analysis of adverse drug reactions reported at a tertiary care hospital in South India


  • Hemavathy G. Department of Pharmacology, Govt. Stanley Medical College, Chennai, Tamil Nadu, India
  • Jeyalalitha Rathinam Department of Pharmacology, Govt. Stanley Medical College, Chennai, Tamil Nadu, India
  • Preethi A. Department of Pharmacology, Govt. Stanley Medical College, Chennai, Tamil Nadu, India
  • Divakar R. Department of Pharmacology, Govt. Stanley Medical College, Chennai, Tamil Nadu, India




Adverse Drug Reactions, Antimicrobial agents, Causality, Preventability, Pharmacovigilance, Severity, Skin reactions


Background: Adverse drug reactions (ADRs) have a major impact on public health. Pharmacovigilance has become an integral part of pharmacotherapy. This study has been undertaken to retrospectively analyze the various adverse drug reactions and to promote the reporting of ADRs among the healthcare providers.

Methods: A retrospective analysis of the reported ADRs over a period of 3 years at a tertiary care hospital, in Chennai was done. Data related to the number of adverse drug reactions, the demographic particulars, details on the drugs administered, type of ADRs, serious events and prevention strategies undertaken was analyzed. ADRs were assessed for their causality, severity, and preventability as per the standard criteria.

Results: A total of 128 suspected ADRs were found to be reported over a period of 3 years. 81.25% ADRs were found to be of mild severity using the Hartwigs scale of assessment, 71.09% were classified as possible using the Naranjo’s causality assessment, the outcome of 63.28% were found to be recovering from the ADR and 41.40 % were under the probably preventable category. The most common ADRs were the skin reactions. The antimicrobial agents were found to have caused the highest number (58.59%) of ADRs followed by NSAIDs (14.84%) and the antihypertensive drugs (14.06%).

Conclusions: The antimicrobial agents were associated with ADRs in majority of the patients. The commonly reported ADR s were the skin reactions.


World Health Organization. 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:// www. apps. who.int/ medicinedocs/ en/d/Jh2992e/6.html. Accessed on 2018 May 12

Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother. 2013;4:S73-7.

Preventable Adverse Drug Reactions: A Focus on Drug Interactions Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm110632.htm . Accessed on 2018 May 11.

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.

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. Perspect Clin Res. 2016;7:181-6.

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

Khan FA, Nizamuddin S, Najmul H, Mishra H. A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India. Int J Basic Clin Pharmacol. 2013;2:548-53.

Lihite RJ, Lahkar M. An update on the Pharmacovigilance Programme of India. Front. Pharmacol. 2015;6:194.

Inocencia MM, Mercedes GL. A prospective study of adverse drug reactions in hospitalized children. Br J Clin Pharmacol. 2009;47:681-8.

Beijer HJM, de Blaey CJ. Hospitalisations caused by adverse drug reactions: A meta-analysis of observational studies. Pharm World Sci. 2002;24:46-54.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting ADRs. American J of Hospital Pharm. 1992;49:2229-32.

Segal AR, Doherty KM, Leggott J, Zlotoff B. Cutaneous Reactions to Drugs in Children. Pediatrics. 2007;120(4):e1082-96.

Naranj OCA, Busto U, Sellars EM, Sandor P, Ruiz I, Roberts EA, et al. Method for Estimating the Probability of Adverse Drug Reactions. Clin Pharmacol Ther. 1981;30:239-45.

Gallagher RM, Kirkham JJ, Mason JR, Bird KA, Williamson PR, Nunn AJ, et al. Development and inter-rater reliability of the Liverpool adverse drug reaction causality assessment tool. PLoS One. 2011 Dec 14;6(12):e28096.

Shamna M, Dilip C, Ajmal M, Mohan PL, Shinu C, Jafer CP, et al. A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Pharma J. 2014 Sep 1;22(4):303-8.

Sre Akshaya S, Srihitha. An Epidemiological Study on Adverse Drug Reactions in Indian Population: Meta-Analysis. IJPCR. 2017;9(10):654-9.

Farshchian M, Ansar A, Zamanian A, Rahmatpour-Rokni G, Kimyai-Asadi A, Farshchian M. Drug-induced skin reactions: a 2-year study. Clin Cosmet Investig Dermatol. 2015;8:53-56.

Sharma VK, Sethuraman G, Kumar B. Cutaneous adverse drug reactions: clinical pattern and causative agents a 6-year series from Chandigarh, India. J Postgrad Med. 2001;47:95

Patel PP, Gandhi AM, Desai CK, Desai MK, Dikshit RK. An analysis of drug induced Stevens-Johnson syndrome. The Ind J of Me Rese. 2012;136(6):1051-3.

Chan SL, Ang X, Sani LL, Ng HY, Winther MD, Liu JJ, et al. Prevalence and characteristics of adverse drug reactions at admission to hospital: a prospective observational study. Bri J of Clin Pharmac. 2016 Dec 1;82(6):1636-46.

Suke SG, Kosta P, Negi H. Role of Pharmacovigilance in India: An overview. Online J Public Health Inform. 2015;7(2):e223.




How to Cite

G., H., Rathinam, J., A., P., & R., D. (2018). A retrospective analysis of adverse drug reactions reported at a tertiary care hospital in South India. International Journal of Basic & Clinical Pharmacology, 7(7), 1257–1262. https://doi.org/10.18203/2319-2003.ijbcp20182423



Original Research Articles