Glufast Adverse Reactions

Adverse reactions were reported in 245 patients (21.5%) of total 1142 patients. The common adverse events were hypoglycemic symptoms (5.8%: See Pharmacology: Clinical Studies under Actions), gastrointestinal disorders such as abdominal distension (1.7%), constipation (1.2%) and diarrhea (1.1%), and headache (1.0%). The laboratory abnormalities were observed in 245 patients (21.5%) of total 1137 patients. The common events were increased pyruvic acid (6.4%), increased γ-GTP (4.1%), increased lactic acid (2.9%), increased ALT (GPT) (2.8%) and increased free fatty acid (2.1%). (At the time of the latest approval of indication.)
Clinically significant adverse reactions: Myocardial infarction (0.1%): Occurrence of myocardial infarction has been reported. Therefore, adequate heart monitoring should be performed and if any abnormalities are observed, administration should be discontinued and appropriate treatment administered.
Hypoglycemia: Hypoglycemic symptoms (dizziness, hunger pangs, tremor, feeling of weakness, cold sweat, loss of consciousness, etc.) may occur. If hypoglycemic symptoms are observed, patients should be treated appropriately with sucrose, glucose or soft drinks containing sufficient amounts of glucose. If hypoglycemia occurs with the concomitant use of α-glucosidase inhibitors, glucose should be administered instead of sucrose, since α-glucosidase inhibitors delay the digestion and absorption of disaccharides. In such cases, administration should be carefully performed while considering decrease of dose to 5 mg at a time.
Hepatic dysfunction: Hepatic dysfunction associated with marked increases in AST (GOT), ALT (GPT) or γ-GTP may occur. In such cases, perform adequate monitoring and if any abnormalities are observed, treatment should be discontinued and appropriate treatment administered.
Other adverse reactions: See Table 4.

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