입원환자에서 자발적으로 보고된 Tramadol의 약물이상사례 프로파일과 관련 인자
Spontaneously Reported Adverse Drug Event Profile of Tramadol and Related Factors in Hospitalized Patients: A Single-Center Study
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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 conducted a multivariable logistic regression analysis. Results : Out of 50,914 tramadol-administrated patients, 499 reported ADEs. Among them, 413 (82.8%) involved intravenous injection while 86 (17.2%) were related to oral administration. The most frequently reported ADE symptom category was gastrointestinal (421 cases, 69.0%), followed by neurological (109 cases, 17.9%). Females exhibited a significant association with ADEs (adjusted OR 1.85, 95% CI 1.47-2.34) and ADEs were notably associated with intravenous injection (adjusted OR 15.90, 95% CI 12.04-20.99). Conclusion : Approximately 1.0% of inpatients receiving tramadol reported ADEs. Notably, factors associated with tramadol-induced ADEs included female sex and intravenous injection.
Abstract
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 conducted a multivariable logistic regression analysis. Results : Out of 50,914 tramadol-administrated patients, 499 reported ADEs. Among them, 413 (82.8%) involved intravenous injection while 86 (17.2%) were related to oral administration. The most frequently reported ADE symptom category was gastrointestinal (421 cases, 69.0%), followed by neurological (109 cases, 17.9%). Females exhibited a significant association with ADEs (adjusted OR 1.85, 95% CI 1.47-2.34) and ADEs were notably associated with intravenous injection (adjusted OR 15.90, 95% CI 12.04-20.99). Conclusion : Approximately 1.0% of inpatients receiving tramadol reported ADEs. Notably, factors associated with tramadol-induced ADEs included female sex and intravenous injection.
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