• SUNIL KUMAR MATHUR Department of Pharmacology, Jawaharlal Nehru Medical College, Ajmer, Rajasthan, India.
  • SAURABH KUMAR JAIN Faculty of Pharmacy, BN Institute of Pharmaceutical Sciences, Bhupal Nobel’s University, Udaipur, Rajasthan, India. https://orcid.org/0000-0002-1702-3626
  • AMUL MISHRA Faculty of Pharmacy, BN Institute of Pharmaceutical Sciences, Bhupal Nobel’s University, Udaipur, Rajasthan, India.




World Health Organization, Program for international drug monitoring, Uppsala monitoring center, Adverse drug reaction


Objective: The objective of this study was to analyze various parameters such as admission type, demographics, type of reaction, organ system classification, drugs involved, action is taken, reaction outcome, causality assessment, severity assessment, and the preventability of Adverse drug reactions (ADRs) in pediatric patients.

Methods: This retrospective observational study was conducted during the period of September 2017 to June 2020 (34 months) at the ADR monitoring center, Department of Pharmacology, Jawaharlal Nehru Medical College, Ajmer, Rajasthan. All spontaneously reported ADRs were evaluated using various parameters such as type of reaction, causality assessment, preventability, and severity.

Results: In the present study, 72 (7.27%) ADRs were reported in relation to 65 pediatric patients. In this study, more ADRs were reported in male (53.85%) as compared to female (46.15%) pediatric patients. The majority of ADRs were considered type B (63.89%), probable (87.5%), moderate (51.39%), and definitely preventable (88.89%) in nature. The majority of ADRs were reported due to antimicrobial classes of drugs, including anthelmintic drug (Albendazole), followed by glycopeptide antibiotic (Vancomycin) and third-generation cephalosporin antibiotics (Ceftriaxone, Cefotaxime, and Cefixime). The organ systems most commonly affected were skin and subcutaneous tissue disorders (47.22%), followed by general disorders and administration site conditions (20.83%) and gastrointestinal disorders (16.67%).

Conclusion: The present study 30 different types of suspected ADRs that were reported with multiple frequencies, with included 34 different categories of drugs and combinations of drugs. The majority of patients recovered, with associated ADR, after necessary medical intervention and management. Our purpose is to minimize the incidence rate of ADRs in the pediatric population.


Download data is not yet available.


Jones JK, Kingery E. History of pharmacovighilance. In: Mann’s Pharmacovigilance. New York: John Wiley and Sons, Ltd.; 2014. p. 11-24.

Salas RD, Soto CM. Pharmacovigiance in Pediatric Population: Pharmacovigilance. London: IntechOpen; 2019.

Guidance Document for Spontaneous Adverse Drug Reaction Reporting. Version 1.0. Reporting of Adverse Drug Reactions. Ch. 3. Indian Pharmacopoeia Commission, National Coordination Centre- Pharmacovigilance Programme of India: 2014.

Sai D, Krishnaiah V, Yashoda H, Pundarikaksha P, Kudagi B, Pathapati RM. Adverse drug reactions in pediatric patients in a tertiary care hospital in India: A prospective observational single centre study. Int J Basic Clin Pharmacol 2016;5:2130-7.

Aagaard L, Hansen EH. Adverse drug reactions reported for systemic antibacterial in Danish children over a decade. Br J Clin Pharmacol 2010;70:765-8. doi: 10.1111/j.1365-2125.2010.03732.x, PMID 21039770.

Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Development pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med 2003;349:1157-67. doi: 10.1056/NEJMra035092, PMID 13679531.

Agbabiaka TB, Savović J, Ernst E. Methods for causality assessment of adverse drug reactions: A systematic review. Drug Saf 2008;31:21-37. doi: 10.2165/00002018-200831010-00003, PMID 18095744.

Le J, Nguyen T, Law AV, Hodding J. Adverse drug reactions among children over a 10-year period. Pediatrics 2006;118:555-62. doi: 10.1542/peds.2005-2429, PMID 16882807.

Rieder M. If children ruled the pharmaceutical industry: The need for pediatric formulations. Drug News Perspect 2010;23:458-64. doi: 10.1358/dnp.2010.23.7.1458283, PMID 20862398.

Griesenauer RH, Kinch MS. 2016 in review: FDA approvals of new molecular entities. Drug Discov Today 2017;22:1593-7. doi: 10.1016/j. drudis.2017.06.011, PMID 28687460.

Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of Adverse Drug Reactions. 1st ed. Oxford: Oxford University Press; 1977. p. 44.

Medical Dictionary for Regulatory Activities Maintance and Support Services Organization (MedDRAMSSO). Available from: http://www. meddramsso.com

World Health Organization. Collaborating Centre for International Drug Monitoring. WHO Programme for International Drug Monitoring: Guide to participating countries-submission in E2B format. Geneva: World Health Organization; 2007.

World Health Organization. WHO Collaborating Centre for Drug Statistics Methodology. Geneva: World Health Organization; 2007. Available from: http://www.whocc.no/atc_ddd_index

The Use of the WHO-UMC System for Standardized Case Causality Assessment. Available from: https://www.who.int/medicines/areas/ quality_safety/safety_efficacy/WHOcausality_assessment.pdf

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-32. doi: 10.1093/ajhp/49.9.2229, PMID 1524068.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538. PMID 10118597.

Aagaard L, Christensen A, Hansen EH. Information about adverse drug reactions reported in children: A qualitative review of empirical studies. Br J Clin Pharmacol 2010;70:481-91. doi: 10.1111/j.1365- 2125.2010.03682.x, PMID 20840440.

Kalyani S, Srihitha P. An epidemiological study on adverse drug reaction in Indian population: Meta-analysis. Int J Pharm Clin Res 2017;9:654-9.

Priyadharsini R, Surendiran A, Adithan C, Sreenivasan S, Sahoo FK. A study of adverse drug reactions in pediatric patients. J Pharmacol Pharmacother 2011;2:277-80. doi: 10.4103/0976-500X.85957, PMID 22025857.

Sindhu AR, Sebastian M, Panicker PR, Muthusamy S, Nallasamy V, Ramanathan S, et al. A study on adverse drug reactions in hospitalised pediatric patients in a tertiary care hospital. J Appl Pharm Sci 2019;9:72-6.

Mrutunjay D, Jena M, Mishra S, Panda M, Patro N. Monitoring of adverse drug reaction in pediatric department of a tertiary care teaching hospital: A hospital based observational study. Int J Pharm Res Allied Sci 2015;4:69-76.

Napoleone E. Children and ADRs (adverse drug reactions). Ital J Pediatr 2010;36:4. doi: 10.1186/1824-7288-36-4, PMID 20180963.

Li H, Guo X, Ye X, Jiang H, Du WM, Xu JF, et al. Adverse drug reactions of spontaneous reports in Shanghi pediatric population. PLoS One 2014;9:e89829.

Rajalakshmi R, Brahmanapalli VD, Prasad TS, Rajesh A, Chennuru S. Analysis of adverse drug reactions in pediatric population. Int Res J Pharm 2020;11:1-5.

Smyth RM, Gargon E, Kirkham J, Cresswell L, Golder S, Smyth R, et al. Adverse drug reaction in children--a systematic review. PLoS One 2012;7:e24061. doi: 10.1371/journal.pone.0024061, PMID 22403604.

Ramesh M, Pandit J, Parthasarathi G. Adverse drug reaction in a South Indian hospital--their severity and cost involved. Pharmacoepidemiol Drug Saf 2003;12:687-92. doi: 10.1002/pds.871, PMID 14762985.



How to Cite

MATHUR, S. K., S. K. JAIN, and A. MISHRA. “A RETROSPECTIVE STUDY: ANALYSIS OF ADVERSE DRUG REACTION IN PEDIATRIC PATIENTS IN A TERTIARY CARE HOSPITAL”. Asian Journal of Pharmaceutical and Clinical Research, vol. 15, no. 9, Sept. 2022, pp. 197-01, doi:10.22159/ajpcr.2022.v15i9.45363.



Original Article(s)