Antibiotic-related adverse events and risk factors in hospitalized patients: a prospective cohort study

Purpose: The objective of this study is to identify antibiotic-related adverse events and risk factors in hospitalized patients. Materials and Methods: This prospective cohort study included 776 inpatients who received antibiotic treatment between January 2019 and December 2020. Patients who experienced "definite" or "probable" adverse drug events (ADE) were examined using the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria. The definition and severity criteria for antibiotic-related adverse events were determined according to the Common Terminology Criteria for Adverse Events (CTCAE). Results: The overall rate of antibiotic-associated ADE was 7.9 (95%CI, 6.8-9.1) per 1000 person-days. The study identified a total of 152 adverse events in 125 patients who experienced ADE. Among the 152 adverse events, 63 (41.4%) were severe, and 89 (58.6%) were non-severe. Independent risk factors for ADE included the number of comorbidities (up to 4 times higher increased risk), number of drugs used, and duration of antibiotic administration (up to 12.3 times higher and 8% increased risk for each additional day). The most common side effects were hematological, with 45 (29.6%) cases reported in the hematological system advers events. Conclusion: The management of antibiotic durations, which is a controllable factor in the development of antibiotic-related adverse events, is crucial. Rational use of antibiotics is essential, not only in terms of preventing the development of resistance but also in terms of reducing the frequency of adverse events that may become life-threatening.