Title

A prospective cross-sectional study on pharmacovigilance of antipsychotic drugs at a tertiary care teaching hospital

Authors

Parth Jain¹, Shashi Marko¹, Lily Dubey¹ & Pawan Gupta^2,*

Affiliation

¹Department of Pharmacology, Bundelkhand Medical College, Sagar, Madhya Pradesh, India; ²Department of Dermatology, Bundelkhand Medical College, Sagar, Madhya Pradesh, India; *Corresponding author

Email

Antipsychotic medications are associated with many adverse drug reactions (ADRs) which affect patient compliance, safety and outcomes, making pharmacovigilance important, that by pharmacovigilance is performed to gather data, make decisions and prevent ADRs of antipsychotic medications. Hence, this is a prospective cross-sectional observational study WHO-UMC scale and Naranjo scale was used to assess the causality of the adverse drug reactions with oral antipsychotic medications. Total 61 patients with adverse drug reactions were observed, 168 adverse drug reactions were observed because of 5 medications; according to WHO UMC scale 52.45% adverse drug reactions were probable/likely and according to Naranjo scale 52.45% adverse drug reactions were possible. Pharmacovigilance helps us assess adverse drug reactions, it guides our clinical decision making and drug selection, it gives us data which helps us better perform risk-benefit analysis of drug administration ultimately serving patient wellbeing.

Article Type

Research Article

Date

Received April 1, 2026; Revised April 30, 2026; Accepted April 30, 2026, Published April 30, 2026

Abstract

Antipsychotic medications are associated with many adverse drug reactions (ADRs) which affect patient compliance, safety and outcomes, making pharmacovigilance important, that by pharmacovigilance is performed to gather data, make decisions and prevent ADRs of antipsychotic medications. Hence, this is a prospective cross-sectional observational study WHO-UMC scale and Naranjo scale was used to assess the causality of the adverse drug reactions with oral antipsychotic medications. Total 61 patients with adverse drug reactions were observed, 168 adverse drug reactions were observed because of 5 medications; according to WHO UMC scale 52.45% adverse drug reactions were probable/likely and according to Naranjo scale 52.45% adverse drug reactions were possible. Pharmacovigilance helps us assess adverse drug reactions, it guides our clinical decision making and drug selection, it gives us data which helps us better perform risk-benefit analysis of drug administration ultimately serving patient wellbeing.

Keywords

Adverse drug reactions (ADRs), causality assessment, WHO-UMC scale, Naranjo scale, antipsychotic drugs, preventability, schumock-thornton scale

Citation

Jain et al. Bioinformation 22(4): 2598-2601 (2026)

Edited by

Ritik Kashwani

ISSN

0973-2063

Publisher

Biomedical Informatics

License

This is an Open Access article which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. This is distributed under the terms of the Creative Commons Attribution License.