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image of Adverse Drug Reactions of Low and Standard Doses of Risperidone in Schizophrenia Outpatients

Abstract

Introduction

Risperidone is an atypical antipsychotic commonly used in the treatment of schizophrenia. Despite its effectiveness, several adverse drug reactions can be bothersome to patients. This study aimed to examine the prevalence and characteristics of adverse effects in outpatients with schizophrenia treated with low (<4 mg/day) and standard (≥4 mg/day) doses of risperidone.

Methods

A cross-sectional study was conducted with 64 patients at a tertiary psychiatric hospital. Data on adverse effects were collected through a self-report questionnaire, and causality was assessed using Naranjo’s Algorithm. Descriptive statistics and chi-square tests were employed for data analysis.

Results

The participants comprised 51.56% females, with a mean age of 45.16±14.32 years. Significant gender differences were observed between dose groups, with more females in the low-dose group (63.16%) than in the standard-dose group (34.62%) ( = 0.02). A total of 221 adverse effects were confirmed after assessment. The most common effects were weight gain (57.81%), increased appetite (48.44%), and dystonia (32.81%). Weight gain was more prevalent in the low-dose group (68.42%) than the standard-dose group (42.31%; Cohen's h = 0.53, 95% CI: 2.0%–50.2%), while insomnia was higher in the standard-dose group (23.08%) compared to the low-dose group (5.26%; Cohen's h = 0.54, 95% CI: 0.1%–35.5%).

Discussion

These findings highlight the importance of monitoring dose-dependent ADR patterns and tailoring interventions to individual patient needs. Several limitations should be acknowledged, including the small sample size and the cross-sectional design, which limits causal inference.

Conclusion

Weight gain was the most prevalent adverse effect associated with risperidone use, particularly at lower doses, while insomnia was more frequent at standard doses, emphasizing the need for careful monitoring and personalized dose adjustments to optimize patient safety.

© 2025 The Author(s). Published by Bentham Science Publishers. This is an open access article published under CC BY 4.0 https://creativecommons.org/licenses/by/4.0/legalcode
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2025-04-18
2025-09-16
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