Prevalence, severity and predictors of Antipsychotic-Related Adverse Drug Reactions at the Psychiatry Clinic of a Regional Referral Hospital in Uganda

Abstract

BACKGROUND: Adverse drug reactions (ADRs) are associated with hospitalization, increased healthcare cost, morbidity and mortality. This study aimed to investigate the prevalence, severity and associated factors of ADRs among patients taking antipsychotics at Mbarara Regional Referral Hospital (MRRH). METHOD: A cross-sectional study was conducted among patients taking antipsychotics at the psychiatric clinic from March to May 2025. Consecutive sampling was employed whereby all eligible patients attending the psychiatric clinic during the study period were recruited until the required sample size was attained. All patients aged 18 years and above, diagnosed with a psychotic disorder, and who had received an antipsychotic for at least the previous one month were interviewed. STATA version 17 was used for statistical data analysis. Descriptive statistics were presented as mean and standard deviation or median and interquartile ranges. ADRs were analyzed for severity using the modified Hartwig and Siegel scale. We run multivariable logistic regression analysis to determine factors associated with ADRs. RESULTS: A total of 415 participants were included in the study with a mean age of 38. Fifteen ADRs were commonly reported among patients taking antipsychotics. More than half of the participants (256/415, 61.70%) experienced at least one ADR, with sedation being the most frequent (31.3%). Of the reported ADRs, 12/15 (80%) were moderate in severity. Separation from spouses (AOR = 2.01, 95% CI [1.08-3.77], p = 0.029), diagnosed with bipolar disorder (AOR = 2.09, 95% CI [1.07-4.07], p = 0.031), and co-administering both IM & oral antipsychotic (AOR = 1.95, 95% CI [1.03-3.70], p = 0.041) were significantly associated with ADRs. CONCLUSION: The current study showed that over 6 in 10 participants taking antipsychotics experienced at least one ADR, the majority of which were moderate in severity. Separation from a spouse, bipolar disorder, concomitant use of oral and intramascular antipsychotics were independently associated with ADRs. These findings highlight the need for strengthen monitoring and preventive strategies, particularly among high-risk patients taking antipsychotics. Integration of clinical pharmacists into the psychiatry care teams may further enhance ADR detection, monitoring and management.