Patients with a more advanced stage of human immunodeficiency virus (HIV) infection are more prone to experience more complications. Meanwhile, long-term treatment of HIV with antiretrovirals (ARVs) may potentially cause adverse drug reactions (ADRs). This study aims to analyze the relationship between HIV clinical stages and the level of ADR probability based on the Naranjo scale. This study was designed as an observational, analytic cross-sectional study. Data were collected based on medical records of adult patients with HIV/AIDS under treatment with ARVs at a regional hospital in Denpasar during 2022-2024. The results showed that among the included HIV/AIDS patients (N = 69), the majority were male, aged 25-49 years (50-72%), with HIV clinical stage 3 (50.72%). The most common ADRs include itching, fever, nausea, and diarrhea (8-20%). ADR of diarrhea was found to be significantly different (p = 0.007) among HIV clinical stages. A statistically significant but weak correlation was observed between clinical stage and ADR probability (τ = 0.179; p = 0.039). Future prospective longitudinal studies are needed to clarify this relationship over time and strengthen pharmacovigilance in HIV patient care.
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