Background: Psycholeptic and psychoanaleptic drugs are associated with adverse effects which can affect the patient compliance and course of treatment. Psychiatrist awareness about this can facilitate rational and safe use of these medicines. Pharmacovigilance studies for psychiatric drugs are found to be very low in our country. Objectives: To assess the types, severity, causality, preventability, predictability and management of Adverse Drug Reactions (ADRs) among Psycholeptics and Psychoanaleptics. Method: A Prospective spontaneous reporting study was carried out for 6 months in the patients of psychiatry department. The study includes the ADRs among the Psycholeptics and Psychoanaleptics in any age of either sex from in-patients. The medication charts of patients were analysed for ADRs. Results: Among the 141 admitted psychiatric patients, 35 ADRs were reported during the course of study. Risperidone and Olanzapine were the frequently used drugs having the highest number of ADRs and tremor was the commonest ADR. Number of ADRs was found to affect the neurological system. Type A reactions were found to be more in males than in females. The causality assessment was done using Naranjo scale and majority of the reports were rated as possible (85.71%). Mild and moderate reactions accounted for 31.43% and 62.86% respectively as per Hartwig scale and only 5.71% of the reactions were found to be severe. Preventability assessment using Schumock and Thornton scale showed that most of the ADRs were definitely preventable (48.57%). Conclusion: Continuously monitoring the safety profile of psychiatric drugs fosters the rational and safe use of the medicines.

Keywords: Adverse Drug Reactions; Psycholeptics; Psychoanaleptics; Antipsychotics.