Gastiin CR Adverse Reactions

Adverse reactions of Mosapride citrate controlled-release tablets: From the randomized, double-blind, active-controlled, parallel-group clinical trial on 138 functional dyspepsia patients, adverse reactions occurred in 12 patients, where the expression rate was found to be 13.24% (9/68, 10 cases) in the test group (controlled-release tablet), and 4.29% (3/70, 3 cases) in the control group (immediate-release tablet). No serious adverse reactions were reported in both the test group and the control group. As the result of analyzing adverse drug reaction expression rate that cannot exclude the causal relation with the clinical drug, diarrhea and nausea were reported in 1.47% each (1/68, 1 case) for total of 2.94% (2/68, 2 cases) from the test group, and none were reported from the control group.
Adverse reactions of Mosapride citrate immediate-release tablets (3 times a day): Adverse reactions were found in 40 of 998 cases (4%) in clinical trials. The main adverse reactions were diarrhea/loose stools (1.8%), dry mouth (0.5%), malaise (0.3%), etc.
Abnormal clinical laboratory test values were observed in 30 of 792 cases (3.8%), which were mainly eosinophilia (1.1%), elevations of triglyceride (1%), AST (GOT), ALT (GPT), ALP and γ-GTP (0.4% each) (at the time of approval).
Clinically Significant Adverse Reactions: Fulminant hepatitis, hepatic dysfunction and jaundice (<0.1%, each). Since fulminant hepatitis, serious hepatic dysfunction accompanied with marked elevations of AST (GOT), ALT (GPT) and γ-GTP, etc and jaundice may occur, and the patient should be monitored carefully as some of these reactions were fatal. If any abnormalities are found, discontinue the administration immediately and give appropriate measures.