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 SHORT COMMUNICATION
Year : 2014  |  Volume : 46  |  Issue : 5  |  Page : 543-546

A prospective observational study to evaluate safety reporting of antidepressants at a tertiary care hospital in India


1 Department of Pharmacy Practice, Jagadguru Sri Shivarathreeshwara College of Pharmacy, Jagadguru Sri Shivarathreeshwara University, Mysore, Karnataka, India
2 Department of Psychiatry, Jagadguru Sri Shivarathreeshwara Hospital, Mysore, Karnataka, India

Correspondence Address:
Ramesh Madhan
Department of Pharmacy Practice, Jagadguru Sri Shivarathreeshwara College of Pharmacy, Jagadguru Sri Shivarathreeshwara University, Mysore, Karnataka
India
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Source of Support: Research grant was received from JSS university, Mysore., Conflict of Interest: None


DOI: 10.4103/0253-7613.140591

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Objective: This prospective observational study was carried out to identify the prevalence and Severity of ADRs of antidepressant in a tertiary care teaching hospital. Materials and Methods: Patients prescribed with at least one antidepressant were randomly selected and monitored for adverse drug reactions (ADRs), irrespective of their age and gender. Results: Of the 401 patients who received antidepressants, 170 patients (42.39%) experienced 204 ADRs. Selective serotonin receptor inhibitors (SSRIs) [110 (53.92)] was the most common therapeutic class of drugs associated with ADRs. Gastrointestinal system [54 (26.47)] was most commonly affected system organ class. Dry mouth (n = 30) and diaphoresis (n = 21) were the most frequently reported ADRs. As assessed by the World Health organization (WHO) probability scale, 61% of the ADRs were 'probable' causality. Among all the ADRs, 22.54% (46) were preventable. Majority of the ADRs [(n = 184) 90.17%] were 'mild' in their severity. Conclusion: In this study, incidence of adverse reaction to antidepressants was 42.3% were the most comman SSRI inplicated drug group for the ADRs.






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