Leukopenia and thrombocytopenia: Leukopenia and thrombocytopenia may occur. Patient should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
Hepatic dysfunction and jaundice: 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 Rebamipide. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
Other adverse reactions: Hypersensitivity*: Rash, pruritus, drug-eruption like eczema, other symptoms of hypersensitivity and urticaria.
Neuropsychiatric: Numbness, dizziness, sleepiness.
Gastrointestinal: Constipation, feeling of abdomen enlarged, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste abnormality and dry mouth.
Hepatic**: Increased AST (GOT), ALT (GPT), γ-GTP, and alkaline phosphatase levels.
Hematologic: Leukopenia, granulocytopenia, and thrombocytopenia.
Other: Menstrual disorders, increased BUN levels, edema and feeling of a foreign body in the pharynx, breast swelling and pain, gynecomastia, induction of lactation, palpitations, fever, facial flushing, numbness of tongue, cough, respiratory distress and alopecia.
* If such symptoms of hypersensitivity occur, the drug should be discontinued.
** If transaminase levels are markedly increased or fever and rash develop, the drug should be discontinued and appropriate measures should be taken.
View ADR Monitoring Form