Monitoring of adverse drug reactions in individuals with type 2 diabetes mellitus receiving oral hypoglycemic agents

Background: This study intends to ascertain the prevalence and overall burden of various adverse drug reactions (ADRs) driven by oral antidiabetics for treating type II diabetes mellitus (T2DM) in India. Methods: Patients with T2DM taking oral antidiabetic medications participated in prospective observational research. Data collection used the pretested format by the Indian pharmacovigilance program to record the history of drugs suspected to be responsible for ADRs. The causality evaluation is according to the guidelines of the Uppsala Monitoring Center and the World Health Organization. Results: This study included 424 patients with established diabetes. Female patients showed a non-significant higher percentage of ADRs (p = 0.059). Naranjo’s assessment recorded 51 suspected ADRs with significant (p = 0.042) categorical differences in casualty. According to ADR severity, there was a significant (p = 0.048) difference between moderate 8.25% (n = 35) and mild 3.80% (n = 16); however, none of the ADRs showed severity. Metformin caused abdominal discomfort, itching, and rashes, accounting for 4.95% (n = 21) of all reported adverse reactions. Gliclazide and glimepiride induced hypoglycemia, itch, and rashes, 1.65% (n = 7), abdominal pain, 1.18% (n = 5), flatulence caused by acarbose, abdominal discomfort caused by pioglitazone, and pedal edema caused by pioglitazone 1.18% (n = 5). Conclusion: ADRs due to oral antidiabetic agents are a frequent problem. Therefore, active pharmacovigilance is essential for risk identification, management, and establishing a robust antidiabetic drug ADR database.