Rebamid 100 Adverse Reactions

Of 10,407 patients treated, adverse reactions including abnormal laboratory findings, were reported in 54 patients (0.54%). Of 3035 patients >65 years, adverse reactions were noted in 18 patients (0.59%). The nature and incidence of adverse reactions were not different between the elderly and younger patients. The summary of data as follows includes adverse reactions voluntarily reported after marketing (figures are total cases reported from the time of approval up to June 2001).
Hypersensitivity: Rash, pruritus and eczematous drug eruption may rarely occur. If such signs of hypersensitivity reactions develop, Rebamipide should be discontinued.
Gastrointestinal: Dry mouth, constipation, sensation of abdominal enlargement, diarrhea, nausea, vomiting, heartburn, abdominal pain and belching may rarely occur.
Hepatic: Signs of hepatic function disorder including increased GOT, GPT, γ-GTP and alkaline phosphatase levels may rarely occur.
Hematologic: Leukopenia may rarely occur.
Others: Mammary gland expansion, nonpuerperal lactation, menstrual disorder, dizziness, increase in BUN level, edema and sensation of foreign body in the pharynx may rarely occur.
Seek medical attention immediately at the first sign of any adverse reaction.