Background : Tramadol stands out as the predominant analgesic responsible for adverse drug events (ADEs) as reported to the Ministry of Food and Drug Safety. In this study, we analyzed the incidence rate, and types of spontaneously reported ADEs induced by tramadol and to identify related factors in hospitalized patients.
Methods :We identified spontaneously reported tramadol-induced ADEs occurrence between January 1, 2020, and December 31, 2021. The incidence rate was calculated as the number of spontaneously reported ADEs divided by the total number of patients receiving tramadol. To identify the associated factors of tramadol-induced ADEs, we constructed the 1:4 matched control group based on the year and month of tramadol administration and