Pattern of Adverse Drug Reactions Reported from General Hospital Psychiatric Unit to Adverse Drug Reaction Monitoring Centre; A Retrospective Study

Background: Psychiatric illnesses often necessitate the use of medications for longer duration, which may lead to a wide spectrum of adverse drug reactions (ADRs). According to Indian studies, the incidence of ADRs in psychiatric outpatient departments varies from 5% to 21.5%. Despite this, the rate of reporting in India remains <1% which is significantly lower than the global average. Aim: The aim of this study was to assess the pattern of ADRs reported from the general hospital psychiatric unit to the ADR monitoring centre (AMC). Materials and Methods: This retrospective observational study is based on data collected from spontaneously reported ADRs in a General Hospital Psychiatric Unit (GHPU) from July 2022 to June 2024. Descriptive analysis was used to analyze sociodemgraphic determinants, diagnosis, treatment, and ADRs. Results: Total recorded ADRs were 201 from 165 patients. Out of which, 60 were male (36.4%) and 105 were female (63.6%). The most commonly observed ADR was sedation in 33.3% ( n = 67), followed by weight gain in 15.9% ( n = 32). Antipsychotics 40.7% ( n = 76) were the most common drug class and olanzapine 18.7% ( n = 35) was the most common drug causing ADRs. Depression 26.1% ( n = 43) was the most common clinical diagnosis. Conclusion: The findings from this study provide a representative profile of ADRs reported to AMC in a GHPU, offering valuable insights into the occurrence and pattern of ADRs associated with psychotropic medications. Psychiatrists should be sensitized regarding reporting of ADRs, as the current reporting rates are very low in India.