Mucosta Adverse Reactions

Of 10,047 patients treated, adverse reactions, including abnormal laboratory findings, were reported in 54 patients (0.54%). Of 3,035 patients aged over 65 years, adverse reactions were noted in 18 patients (0.59%). The nature and incidence of adverse reactions were not different between the same in elderly and younger patients. The following summary of data includes adverse reactions voluntari1y reported after marketing (Figures are total cases reported at the time of approval and at the completion of reexamination of MUCOSTA Tablet 100).
Clinically significant adverse reactions: Shock, anaphylactoid reactions (incidence unknown*): Shock or anaphylactoid reactions may occur. Patients should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
Leukopenia (incidence <0.1%) and thrombocytopenia (incidence unknown*): Leukopenia and thrombocytopenia may occur. Patients should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
Hepatic dysfunction (incidence <0.1 %) and jaundice (incidence unknown*): Hepatic dysfunction and jaundice, as indicated by increases in AST (GOT), ALT (GPT), γ-GTP, and alkaline phosphatase levels, have been reported in patients receiving MUCOSTA Tablets. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken
Other Adverse Reactions: (See Table 2.)

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