Adverse drug reactions (ADRs) to psychotropic agents are common and maydirect to noncompliance or even termination of therapy. We considered it worthwhile to assess the suspected ADR profile of psychotropic drugs administered for schizophrenic patients in the psychiatric unit of a tertiary care teaching hospital in south India.A prospective observational study was carried out in the in-patient department of the concerned psychiatric unit. Adverse event history, medication history and other relevant details were recorded in a specially designed format.The collected ADRs were assessed for causality, probability, severity, predictability and preventability. 200 schizophrenic patients were recruited in the study. We have recorded 352 suspected ADRs. The most commonly reported ADRs are dizziness (14.20%) followed by drowsiness (6.81%), constipation (6.53%) hypersalivation (6.53%), tremor (6.25%), insomnia (5.68%),orthostatic hypotension(5.11%), sedation (4.82%) and blurred vision (4.82%).Causality assessment byNaranjo’s scale shows that out of 352 reported ADRs, 49.14% are possible. Probability assessment byWHO scale shows that 45.2% of ADRs are possible. Severity assessment by Hartwig and Siegel scaleshows that 73.3% of ADRs are mild. Predictability assessment reveals that 96.5% of ADRs are predictable. Preventabilityassessment by Modified Schumock and Thornton’s Scale shows that91.5% of ADRs are not preventable. Among the psychotropic drugs, antipsychotics represented the majority, with olanzapine topping the list (30.96%) followed by risperidone (29.26%). This study presents a representative profile of ADRs to be expected in schizophrenic in-patients in asouth Indian tertiary care hospital.
