A retrospective analysis of adverse drug reactions in a tertiary care teaching hospital at Dehradun, Uttarakhand

Shakti B. Dutta, Mirza Atif Beg, Shalu Bawa, Mohammed Anjoom, Amit Varma, Nand K. Singh, Anil K. Mehta, Sandip K. Kudesia


Background: Adverse drug reactions (ADRs) are one of the major causes of hospital admissions. The objective of this study was to ascertain the various ADRs occurring in a tertiary care teaching hospital at Dehradun, Uttarakhand.

Methods: The ADRs were collected from January 2010 to June 2014 by the Department of Pharmacology in Shri Guru Ram Rai Institute of Medical & Health Sciences, Dehradun, Uttarakhand. A total of 123 ADRs were collected, analyzed and assessed on WHO causality assessment scale.

Results: A total of 123 ADRs were assessed. Male:female ratio was 1.5:1. Age-wise distribution of ADRs was done: 0-15 years had 15 (12.19%), 16-30 had 50 (40.65%), 31-45 showed 25 (20.32%), 46-60 years 22 (17.88%) and >60 years had 11 (8.94%). 112 (91.05%) ADRs were serious, and 11 (8.94%) were non-serious. As per the WHO causality assessment scale, 91 (73.98%) ADRs were probable, 30 (24.39%) were possible, and 2 (1.62%) were certain. Most commonly occurring ADRs were fixed drug eruption in 42 (34.14%) patients, erythematous maculopapular rash in 20 (16.26%) patients and urticarial rash in 15 (12.19%) patients, followed by others. The drugs most frequently associated with ADRs were non-steroidal anti-inflammatory drugs (NSAIDs), fluoroquinolones, penicillins, cephalosporins and phenytoin sodium, followed by others.

Conclusions: Majority of ADRs were probable according to WHO causality assessment scale. Most common ADR was fixed drug eruption. Most frequent drugs associated with ADRs were NSAIDs. ADRscontribute to increased morbidity and mortality in patients; thereby pose a huge burden on the society.


WHO causality assessment scale, Adverse drug reaction, Fixed drug eruption, Non-steroidal anti-inflammatory drugs

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