Chemical formula: C₁₉H₁₅ClN₂O₄ Molecular mass: 370.072 g/mol PubChem compound: 5042
This drug should be administered to pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk. The safety of this drug in pregnant women has not been established.
Nursing should be interrupted when this drug is administered to. Rat studies have shown that rebamipide is excreted in the breast milk.
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 showed no differences between elderly and younger patients. The following summary of data includes adverse reactions voluntarily reported after marketing (Figures are total cases reported at the time of approval and at the completion of reexamination of rebamipide tablets 100 mg).
1) 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.
2) Leukopenia (incidence <0.1%) and thrombocytopenia (incidence unknown*): 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.
3) Hepatic dysfunction (incidence <0.1%) and jaundice (incidence unknown•): Hepatic dysfunction and jaundice, as indicated by increases in AST (GOT), ALT (GPT), y-GTP, and alkaline phosphatase levels, have been reported in patients receiving rebamipide Tablets. Patient should therefore be closely monitored. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
| <0.1% | *Incidence Unknown | |
|---|---|---|
| Hyper-sensitivitynote1 | Rash, pruritus, drug- eruption-like eczema, other symptoms of hypersensitivity | Urticaria |
| Neuro-psychiatric | Numbness, dizziness, sleepiness | |
| Gastro-intestinal | Constipation, feeling of abdomen enlarged, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste abnormality, etc. | Thirst |
| Hepaticnote2 | Increased AST (GOT), ALT (GPT), y-GTP, alkaline phosphatase levels | |
| Hematologic | Leukopenia, granulocytopenia, etc. | Thrombocytopenia |
| Other | Menstrual disorders, increased BUN levels, edema, 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, alopecia |
Note 1: If such symptoms of hypersensitivity occur, the drug should be discontinued frequency
Note 2: If transaminase levels are markedly increased or fever and rash develop, the drug should be discontinued and appropriate measures should be taken.
* The incidence rates of voluntarily reported adverse reactions are not known.
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