Antibiotic-Associated Adverse Drug Reactions: A Prospective Observational Study

Background: Antibiotics are commonly prescribed drugs and are frequently associated with adverse drug reactions (ADRs), contributing to patient morbidity and prolonged hospital stay. Aim of the study was to evaluate the clinical pattern, causality, severity, seriousness, and outcomes of antibiotic-associated ADRs in a tertiary care hospital. Materials and Methods: This prospective observational study included 50 patients who developed suspected antibiotic-associated ADRs. Data was collected using a structured case record form (CRF). Causality was assessed using WHO-UMC scale, and severity was graded using the Modified Hartwig and Siegel scale. Statistical analysis was performed using descriptive statistics and Chi-square test. Results: The mean age was 46.8 ± 15.2 years with male predominance (56%). Cephalosporins were the most commonly implicated antibiotics (28%). Skin manifestations (42%) were the most frequent ADRs, followed by gastrointestinal reactions (28%). Type B reactions accounted for 60% of cases. Serious ADRs occurred in 16% of patients. Most patients recovered completely (74%), with no mortality. Significant associations were observed between age and severity (p = 0.041) and antibiotic class and organ system involvement (p = 0.032). Conclusion: Antibiotic-associated ADRs are common but largely manageable. Strengthening pharmacovigilance and rational antibiotic use can improve patient safety.