ADVERSE DRUG REACTION PROFILE OF THEOPHYLLINE IN COPD PATIENTS WITH AND WITHOUT TYPE 2 DIABETES MELLITUS

Background: Chronic obstructive pulmonary disease (COPD) is a major global health problem characterized by persistent airflow limitation and chronic airway inflammation. Theophylline is widely used as a bronchodilator in COPD management, however its narrow therapeutic index makes it prone to adverse drug reactions (ADRs). Diabetes mellitus is a common comorbidity among COPD patients and may influence drug metabolism and pharmacokinetics. Objective: To evaluate and compare the adverse drug reaction profile of theophylline in COPD patients with and without Type 2 Diabetes Mellitus. Methods: A cross‑sectional observational study was conducted including 74 COPD patients. Patients were divided into two groups: COPD without diabetes (Group A) and COPD with Type 2 diabetes mellitus (Group B). All patients received a fixed dose combination of Etofylline 77 mg and Theophylline 23 mg administered three times daily. ADRs were monitored and causality was assessed using WHO‑UMC criteria. Results: Nausea was the most commonly reported ADR followed by seizures and arrhythmias. The incidence of ADRs did not differ significantly between COPD patients with and without diabetes. WHO‑UMC causality assessment showed that most reactions were classified as possible or probable. Conclusion: The study demonstrates that theophylline therapy is associated with predictable ADR patterns and careful monitoring is essential due to its narrow therapeutic index.