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Clinically Significant Adverse Reactions (Frequency Unknown*): Convulsion: Incidence of convulsion was reported in dialysis patients. Patients should be carefully monitored, and appropriate measures eg, discontinuing treatment, should be taken if any abnormality is observed.
The following adverse reactions may occur. Patients should be carefully monitored and appropriate measures eg, discontinuing treatment, should be taken if any abnormality is observed.
Hypersensitivity (<0.1%): Itching, rash.
Gastrointestinal (0.1% to <1%): Anorexia, nausea, vomiting, diarrhea, heartburn.
Other (<0.1%): Drowsiness.
*The frequency of adverse reactions on the basis spontaneous reports is unknown.
Ampoule: Summary of the incidence of adverse reactions: The most frequently observed adverse reactions reported in a total of 2972 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).
Clinically Significant Adverse Reactions (Frequency Unknown*): Shock: Since shock may occur, patients should be carefully monitored and appropriate measures eg, discontinuing treatment, should be taken if any abnormality is observed. (See also Other Adverse Reactions as follows.)
Convulsion: Incidence of postsurgical convulsion was reported in patients underwent cardiac macrovascular surgery assisted with cardiopulmonary bypass and received perioperative Transamin treatment. Incidence of convulsion was reported in dialysis patients. Patients should be carefully monitored, and appropriate measures eg, discontinuing treatment, should be taken if any abnormality is observed.
Other Adverse Reactions: Hypersensitivity (<0.1%): Itching, rash.
Gastrointestinal (0.1% to <1%): Nausea, vomiting. (<0.1%): Anorexia, diarrhea.
Ocular (Unknown*): Transient defective color vision (IV injection).
Others (<0.1%): Drowsiness, headache.
*The frequency of adverse reactions on the basis spontaneous reports or overseas resources is unknown.
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