Published: 2019-12-24

Pattern of adverse drug reactions reported at a tertiary care teaching hospital in Punjab

Vaishalee Punj, Rahat Kumar


Background: This study was undertaken to characterize the pattern of adverse drug reactions (ADRs) reported through spontaneous reporting system at ADR reporting unit in a tertiary care teaching hospital (Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar).

Methods: A prospective, observational study was conducted over one year between 1st July, 2013 and 30th June, 2014. The ADRs reported were from patients attending outpatient department (OPD) and in-patient department (IPD) of this hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and ADR characteristics and outcome of the ADRs. Causality and severity assessment was done by WHO-UMC system and modified Hartwig and Siegel criteria.

Results: A total of 202 ADRs which were reported over one year were evaluated. Overall ADRs were more common in females than in males (60.2% vs. 39.8%). Majority of the ADRs were reported from psychiatry department (50%). Most ADRs occurred due to antidepressant drugs (55.1%). Majority of the ADRs involved the central nervous system (25.24%). Upon causality and severity assessment, majority of the reports were rated as probable (57.42%) and mild (57.92%). None of the ADRs were severe or fatal.

Conclusions: In conclusion, majority of the ADRs were reported by psychiatry department and occurred due to antidepressant drugs. Most of the ADRs were mild. This data reveals the need for regular spontaneous reporting by healthcare professionals of all specialties. This data also reveals the opportunities for interventions and policy initiatives to ensure safer use of drugs in future.


Adverse drug reactions, ADR reporting, ADR outcomes

Full Text:



WHO. Adverse reaction. WHO, 1972. Available at: Accessed on 3 June 2019.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200-5.

Lindquist M. VigiBase, the WHO Global ICSR Database System: basic facts. Drug Inf J. 2008;42(5):409-19.

Mazzitello C, Esposito S, De Francesco AE, Capuano A, Russo E, De Sarro G. Pharmacovigilance in Italy: an overview. J Pharmacol Pharmacother. 2013;4(1):20-8.

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

Rabbur RSM and Emmerton L: An introduction to adverse drug reaction reporting systems in different countries. Int J Pharm Pract. 2005;13:91-100.

Alomar MJ. Factors affecting the development of adverse drug reactions (Review article). Saudi Pharm J. 2014;22(2):83-94.

The use of the WHO-UMC system for standardized case causality assessment. Available at: Accessed on 28 October 2019.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Syst Pharm. 1992;49:2229-32.

Zopf Y, Rabe C, Neubert A, Gassmann KG, Rascher W, Hahn EG, et al. Women encounter ADRs more often than do men. Eur J Clin Pharmacol. 2008;64(10):999-1004.

Rehan HS, Chopra D, Sah RK, Mishra R. Adverse Drug Reactions: Trends in a Tertiary Care Hospital. Curr Drug Safety. 2012;7:384-8.

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.

Jayanthi CR, Bose D, Sushma M. Evaluation of pattern, predictability, severity and preventability of adverse drug reactions in the department of psychiatry at a tertiary care hospital in Bengaluru - a five years experience. Int J Res Pharmacol Pharmacotherapeutics. 2017:6(2);182-90.

Behera SK, Rath B, Biswal SB and Mohapatra S. Pattern of adverse drug reactions in a tertiary care hospital in Western Odisha. Int J Pharm Sci Res. 2018;9(6):2471-7.

Parretta E, Rafaniello C, Magro L, Coggiola Pittoni A, Sportiello L, Ferrajolo C, et al. Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy. Expert Opin Drug Saf. 2014;13(1):21-9.