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International Journal of Recent Trends in Science and Technology, ISSN 2277-2812 E-ISSN: 2249-8109

Volume 9, Issue 1, November 2013 pp 81-85

Research Article

Profile of Suspect Adverse Drug Reactions in a Teaching Hospital


Shubhatara Swamy, Pratibha Nadig*, Bhanuprakash**, Muralimohan***, Manjula Shetty#

{Assistant Professor, *Professor, Department of Pharmacology}{**Professor, Department of Dermatology}

{***Professor, Department of Emergency Medicine}

Vydehi Institute of Medical Sciences and Research Centre, Bangalore, Karnataka, INDIA.

#Principal Investigator, Manipal Acunova, Manipal, Karnatka, INDIA.


Academic Editor : Dr. Aher K.R.



Purpose: The present study was carried out to analyse the profile of suspect adverse drug reactions (ADRs) reported to the Pharmacovigilance unit. The primary objective was to identify the common drugs implicated and the pattern of the reactions, which would ensure a judicious prescription and further prevention. Methods: An awareness building lecture on voluntary reporting of ADRs was conducted after which ADR forms were distributed to various departments. They were assessed for the type of reaction based on Rawlins and Thomson criteria; severity based on Hartwig’s scale; seriousness as per Centre for Drugs Standards Control Organisation; expectedness as defined by International Conference on Harmonisation and causality based on Naranjo’s algorhythm. The common group of offending class of drugs were also identified. The results were analysed using descriptive statistics. Results: Out of 75 reactions 74 (98.67%) were type B and 1 reaction (1.33%) was type A. There were 5 unexpected reactions. Sixty four reactions (85.3%) were mild, 4 (5.33%) moderate and 7 (9.33%) were severe in nature. Seven (9.33%) out of 75 were considered serious as they required hospitalisation. The causality assessment for 154 drugs from 75 forms showed 118 (51%) to be possibly related, 36 (49%) as probably related and none were definitely related. The major group of drugs implicated were Antimicrobials followed by Non-steroidal anti-inflammatory drugs. Conclusion: ADRs were mostly due to antimicrobials and Non-steroidal anti-inflammatory drugs. It is necessary to create more awareness to curb irrational polypharmacy which helps in prevention and an accurate diagnosis of the reactions.