Adverse drug reactions to this drug, including abnormalities in laboratory data, were reported in 64 of 10,176 patients (0.63%). The most frequently observed adverse drug reactions were hepatic function abnormal in 12 patients (0.12%), increased ALT (GPT) in 12 patients (0.12%), increased AST (GOT) in 7 patients (0.07%), constipation in 6 patients (0.06%), rash in 5 patients (0.05%), itching, diarrhea and increased ALP in each 3 patients (0.03%).
(At the end of the reexamination period of Gaslon N Tablets and Fine Granules.) (See Table 3.)
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