BFluid Adverse Reactions

Reported incidence rates are based on the results obtained for 50 patients who had undergone gastrointestinal surgery in a phase III clinical study. With regard to adverse events (clinically significant adverse reactions), a total of 8 patients (16.0%) experienced 11 adverse reactions, including vascular pain (3), phlebitis (4), and chest discomfort (1) in a total of 7 patients as subjective or objective manifestations and elevated serum AST (GOT) levels (1), elevated serum ALT (GPT) levels (1), and elevated serum ALP levels (1) in a total of 1 patient as abnormal changes in laboratory data. (These data were obtained at the time of drug approval in Japan, 2006.) Refer to the Pharmacology: CLINICAL STUDIES under Actions.
Clinically significant adverse reactions: Shock^[Note] (frequency unknown): Shock may occur. Patients should be closely monitored, and if any signs or symptoms such as decreased blood pressure, chest discomfort, or dyspnea occur, administration should be discontinued immediately and appropriate measures should be taken.
Note: Adverse reactions commonly associated with thiamin chloride hydrochloride injections.
Other adverse reactions: If other adverse reactions are observed, take appropriate measures such as discontinuing administration. (See Table 7.)

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