Transamin Injection Adverse Reactions

Summary of the incidence of adverse reactions: The most frequently observed adverse reactions reported in a total of 2,972 patients were nausea 0.07% (2 events), vomiting 0.17% (5 events), anorexia 0.03% (1 event), diarrhea 0.07% (2 events) and drowsiness 0.03% (1 event) (based on data obtained from the literature [outside the scope of reexamination]).
(1) Clinically significant adverse reactions (frequency unknown*): 1) Shock: Since shock may occur, patients should be carefully monitored, and appropriate measures, such as discontinuing treatment should be taken if any abnormality is observed.
2) Convulsion: Incidence of postsurgical convulsion was reported in patients who underwent cardiac macrovascular surgery assisted with cardiopulmonary bypass and received perioperative Transamin treatment. An incidence of convulsion was reported in dialysis patients. Patients should be carefully monitored, and appropriate measures, such as discontinuing treatment, should be taken if any abnormality is observed.
(2) Other adverse reactions: The following adverse reactions may occur. Patients should be carefully monitored, and appropriate measures, such as discontinuing treatment should be taken if any abnormality is observed. (See Table 2.)

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