A cross-sectional survey conducted at the psychiatric outpatient clinic of Mbarara Regional Referral Hospital (MRRH) between March and May 2025 included 415 adults receiving antipsychotic therapy. All participants were aged 18 years or older, had a diagnosis of a psychotic disorder, and had been on antipsychotic medication for at least one month. Using consecutive sampling, the study found that 256 of 415 participants (61.70%) reported at least one antipsychotic-related adverse drug reaction (ADR).
The mean age of participants was 38 years. The study therefore indicates that more than six in ten patients attending this regional psychiatry clinic experienced at least one ADR while on antipsychotic treatment.
Fifteen distinct ADRs were commonly reported among study participants. The single most frequent symptom was sedation, reported by 31.3% of the cohort. When severity was assessed using the modified Hartwig and Siegel scale, 12 of the 15 reported ADRs (80%) were classified as moderate in severity. The authors list other ADRs described in the study population, including examples commonly observed with antipsychotic therapy such as weight gain, sexual dysfunction, tardive dyskinesia, akathisia, muscle stiffness, hyperglycemia, vomiting, dry mouth and slurred speech; however, the full frequency distribution by ADR type is reported within the paper’s tables and figures.
This was a facility-based cross-sectional study at MRRH’s psychiatric clinic. Data collection ran for three months and used consecutive sampling: all eligible patients who attended the clinic during the study period were recruited until the target sample size was reached. Eligibility criteria were age 18 years or older, a clinical diagnosis of a psychotic disorder, and receipt of an antipsychotic medication for at least one month prior to the interview. The study followed standard ethical and methodological procedures for observational pharmacovigilance in an outpatient psychiatric setting.
Data were analyzed in STATA version 17. Descriptive statistics were summarized as means with standard deviations or medians with interquartile ranges as appropriate. ADR severity was assessed with the modified Hartwig and Siegel scale, which the investigators used to classify reported reactions as mild, moderate or severe; the majority of ADRs were moderate. To identify factors associated with experiencing an ADR, the authors fitted multivariable logistic regression models and report adjusted odds ratios (AORs) with 95% confidence intervals and p-values.
Three variables were identified as independently associated with experiencing at least one ADR in multivariable analysis:
Participants who were separated from their spouses had higher odds of reporting an ADR (AOR = 2.01; 95% CI 1.08–3.77; p = 0.029).
A diagnosis of bipolar disorder was associated with increased odds of ADRs compared with other psychiatric diagnoses (AOR = 2.09; 95% CI 1.07–4.07; p = 0.031).
Concomitant use of both intramuscular (IM) and oral antipsychotic formulations was associated with higher odds of ADRs (AOR = 1.95; 95% CI 1.03–3.70; p = 0.041).
The authors note that other drug-, patient- and illness-related factors can contribute to ADR risk, including type of antipsychotic, polypharmacy, route and frequency of administration, age, gender, social support and comorbid conditions; however, only the three factors above were independently significant in this dataset.
The high prevalence of ADRs—most of moderate severity—highlights the need for strengthened detection, monitoring and prevention strategies in the outpatient psychiatric setting. The authors recommend enhanced pharmacovigilance for patients initiating or receiving antipsychotics, with particular attention to identified high-risk groups such as patients with bipolar disorder, those receiving both IM and oral antipsychotics, and patients experiencing social stressors such as separation from a spouse.
Integration of clinical pharmacists into psychiatry care teams is suggested as a strategy to improve ADR detection, monitoring and management, and to support interventions that may reduce ADR-related morbidity, non-adherence and health-care utilization.
The study design was cross-sectional, which limits causal inference about predictors and temporality between exposures and ADRs. Detailed frequency data for each ADR type and other subgroup analyses are reported in the paper’s tables and supporting figures. The authors state that all relevant data are included in the paper and supporting information files. Funding for the study was provided by the Deanship of Research and Graduate Studies at King Khalid University in the form of a Large Research Project grant. The authors declared no competing interests.
Overall, this regional outpatient study documents a substantial burden of antipsychotic-related ADRs in Uganda and identifies actionable patient and treatment factors associated with increased risk. Strengthened monitoring, preventive measures and multidisciplinary care including clinical pharmacy input are emphasized as practical responses to these findings.