A study on clinical profile of patients presenting with adverse drug reaction: a hospital based prospective observational study

Ram Singh, Jatinder Kumar Mokta, Kiran Mokta, Surinder Thakur, Rajesh Bhawani, Ramesh .


Background: The aim of the study was to study the clinical profile of patients presenting with adverse drug reaction.

Methods: The study was conducted in the Department of Medicine, IGMC Shimla from 01 July 2015 to 30 June 2016. A total of 129 patients were included in this study. A detailed history was taken followed by examination of patients. The routine investigations were done and special investigations as per need. For analysis patients detail, suspected drugs and the adverse drug reactions caused by them were used.

Results: Bleeding from various sites was the most common event (39.5%), followed by symptomatic hypoglycemia 22.5% of events and symptomatic hyponatremia in 16.3% events. Amongst various drug classes anticoagulants were the most commonly involved drug class followed by oral hypoglycaemic agents, diuretics and antiplatelets. Type A was predominant ADR constituting (97.7%) of total ADRs and only (2.3%) of ADRs were of type B. After causality assessment, majority 86 (66.6%) were probable related and large number 127 (98.3%) of ADRs were serious which recovered after hospitalization.

Conclusions: Our study revealed that ADRs are frequent and are easily recognized in clinical practice and are mostly preventable. Most ADRs are due to the use of drugs with high toxicity for example, warfarin often results in bleeding. It also shows that careful drug monitoring in hospitals  may lead to reduction of many such ADRs, suggesting that some type A, ADRs may be due to inadequate monitoring of therapies and doses. This study will aid the development of interventions to reduce the impact of ADRs in hospital in-patients.


Adverse drug reaction, Gastrointestinal bleeding, Anticoagulants

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