Risk factors for severe adverse drug reactions in hospitalized patients.

Background: Severe adverse drug reactions (sADRs) are becoming increasingly common nowadays. The incidence of sADRs is approaching 6.7%, and the incidence of fatal adverse reactions is 0.32% in hospitalized patients. Of these, 48.5% are, at least potentially, preventable. Aims: This study's objective was to determine factors associated with the occurrence and preventability of sADRs occurring at the tertiary level. Methods: A case-control retrospective-prospective clinical observational study design was used for the study. The research cohort included patients hospitalized at the University Clinical Center (UCC) in Kragujevac, Serbia, from January 1, 2019 to January 1, 2024. The research comprised 147 individuals who were admitted to the UCC in Kragujevac. There were 49 patients with sADRs and 98 controls. Results: Significant factors associated with sADRs in our study were a total number of consultations (ORadjusted = 5.60), Charlson comorbidity index (ORadjusted = 0.30), C-reactive protein (ORadjusted = 1.07), prescribed antihistamines (ORadjusted = 14.37), and antihypertensives (ORadjusted = 0.15). Conclusion: We have identified the factors that are associated with sADRs should be kept in mind while working with patients at the tertiary level. Early detection of those factors may help with early notification of sADRs and their prevention.