Transamin Adverse Reactions

Summary of the incidence of adverse reactions:
Capsule/Tablet: The most frequently observed adverse reactions reported in a total of 2954 patients were anorexia (18 events) in 0.61%, nausea (12 events) in 0.41%, vomiting (6 events) in 0.2%, heartburn (5 events) in 0.17%, itching (2 events) in 0.07% and skin rash (2 events) in 0.07% (based on data obtained from the literature [outside the scope of re-examination]).
The following adverse reactions may occur. If any abnormalities occur, appropriate action should be taken eg, discontinuing Transamin if necessary.
0.1% to <1%: Gastrointestinal: Anorexia, nausea, vomiting, diarrhea and heartburn.
<0.1%: Hypersensitivity: Pruritus, skin rash, etc.
Others: Drowsiness.
Ampoule: The most frequently observed adverse reactions reported in a total of 2972 patients surveyed were anorexia (2 events) in 0.07%, vomiting (5 events) in 0.17%, nausea (1 event) in 0.03%, diarrhea (2 events) in 0.07% and drowsiness (1 event) in 0.03% [based on data obtained from the literature (outside the scope of re-examination)].
Clinically significant adverse reactions (frequency unknown*): Shock: Since shock may occur, the patient should be carefully monitored. If any signs of shock are observed, administration of Transamin should be discontinued and appropriate therapeutic measures taken.
Others: The following adverse reactions may occur. If any abnormalities occur, appropriate action should be taken eg, discontinuing Transamin if necessary.
0.1% to <1%: Gastrointestinal: Nausea and vomiting.
<0.1%: Hypersensitivity: Pruritus, skin rash, etc.
Gastrointestinal: Anorexia and diarrhea.
Others: Drowsiness and headache.
Unknown*: Ocular: Transient defective color vision.
*The incidence of adverse reactions on the basis of spontaneous reports or overseas resources is unknown.