<![CDATA[Diabetes mellitus is a chronic metabolic disease associated with high morbidity and mortality worldwide. Long-term antidiabetic therapy is necessary to achieve optimal glycemic control; however, prolonged medication use may increase the risk of adverse drug reactions (ADRs), potentially affecting treatment outcomes and patient safety. Monitoring ADRs is therefore an important component of pharmacovigilance in diabetes management. This study aimed to determine the profile of ADRs associated with antidiabetic therapy among outpatients with type 2 diabetes mellitus using the Naranjo Algorithm. A retrospective cross-sectional observational study was conducted at the Internal Medicine Outpatient Clinic of RSUD Ibu Fatmawati Soekarno, Surakarta, in May 2026, using a recall method to capture antidiabetic drug-related side effects experienced over the preceding three months. A total of 118 adult and elderly patients diagnosed with type 2 diabetes mellitus and receiving antidiabetic therapy were included. Data were collected through structured patient interviews and medical record review. ADRs were evaluated using the Naranjo Algorithm, and data were analyzed using descriptive statistics and Fisher's exact test. Among the participants, 10.2% experienced ADRs related to antidiabetic therapy, with symptoms of hypoglycemia being the most frequently reported manifestation. Most ADRs were classified as possible, with the remainder classified as probable, based on the Naranjo Algorithm. Fisher's exact test analysis showed that the results were not able to demonstrate a significant association between patient characteristics and ADR occurrence. A larger sample size and a multicenter design are recommended to improve the generalizability of future findings. These findings highlight the importance of routine ADR monitoring to enhance pharmacovigilance and improve the safety of antidiabetic therapy in patients with type 2 diabetes mellitus.]]>
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