title: A prospective observational study to evaluate safety reporting of antidepressants at a tertiary care hospital in India.
abstract: OBJECTIVE
  This prospective observational study was carried out to identify the prevalence and Severity of ADRs of antidepressant in a tertiary care teaching hospital.
  
  
  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.
  
  
  CONCLUSIONS
  In this study, incidence of adverse reaction to antidepressants was 42.3% were the most common SSRI inplicated drug group for the ADRs.
authors.affiliation: Department of Pharmacy Practice, Jagadguru Sri Shivarathreeshwara College of Pharmacy, Jagadguru Sri Shivarathreeshwara University, Mysore, Karnataka, India.
authors.forename: Jisha M
authors.initials: JM
authors.lastname: Lucca
authors.affiliation: Department of Pharmacy Practice, Jagadguru Sri Shivarathreeshwara College of Pharmacy, Jagadguru Sri Shivarathreeshwara University, Mysore, Karnataka, India.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Madhan
authors.affiliation: Department of Pharmacy Practice, Jagadguru Sri Shivarathreeshwara College of Pharmacy, Jagadguru Sri Shivarathreeshwara University, Mysore, Karnataka, India.
authors.forename: Parthasarathi
authors.initials: P
authors.lastname: Gurumurthy
authors.affiliation: Department of Psychiatry, Jagadguru Sri Shivarathreeshwara Hospital, Mysore, Karnataka, India.
authors.forename: Ram
authors.initials: R
authors.lastname: Dushad
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects*; D002648:Child; D005260:Female; D006801:Humans; D015994:Incidence; D007194:India; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*; D012720:Severity of Illness Index; D062606:Tertiary Care Centers; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors
keywords: Adverse effects; antidepressants; depression; psychiatric patients; psychiatry