Oralax-C Adverse Reactions

Results obtained up to the time of completion of post-marketing surveillance for reexamination: Out of a total of 11,866 patients, 298 patients (2.51%) presented adverse reactions. The primary reactions were 100 cases of vomiting (0.84%), 55 cases of abdomen enlarged feeling (0.46%), 54 cases of retching (0.46%), 40 cases of feeling cold (0.34%), 37 cases of nausea (0.31%), etc. Anomaly of laboratory findings was seen in 157 patients (0.31%) or 224 cases. The primary ones were 28 cases of ketone bodies urine positive (0.24%), 22 cases of GOT increased (0.19%) and 16 cases of LDH increased (0.13%).
Results of a controlled study dedicated to the addition of the previous day dosing method: Out of a total 147 dosed patients, 130 patients (88.4%) (including anomaly of laboratory findings) presented adverse reactions. The primary ones were 92 cases of abdomen enlarged feeling (62.6%), 52 cases of nausea (35.4%), 34 cases of abdominal pain (23.1%), 40 cases of feeling cold (27.2%), 20 cases of malaise (13.6%), 15 cases of dizzy feeling (10.2%), 9 cases of vomiting (6.1%), 7 cases of headache (4.8%), 6 cases of sleep loss (appeared only in the previous day dosing method) (4.1%). 6 cases of bilirubin value increased (4.1%), 4 cases of GOT increased (2.7%), 2 cases of GPT increased (1.4%), etc. It should be noted that in this paragraph, all subjective and symptoms with which causal relationship of product cannot be denied were included in the category of adverse reactions.
Clinically significant adverse reactions: Shock, anaphylactoid symptoms: Since shock and anaphylactoid symptoms may occur, close monitoring should be carried out and when pallor facial, blood pressure decreased, vomiting, continuous nausea, feeling bed, vertigo, feeling cold, urticaria, dyspnea, face oedema and so forth arise, administration should be discontinued and adequate treatment should be given. In the case of letting patients take product at home, it is necessary to offer them guidance by referring to Important Basic precautions under Precautions.
Intestinal perforation: Since intestinal perforation may occur, close monitoring should be carried out and when anomaly is observed, administration should be discontinued and adequate treatment should be given. In the case of letting patients take product at home, it is necessary to offer them guidance by referring to Important Basic precautions under Precautions.
Hyponatremia: Since vomiting may cause hyponatremia which can lead to the consciousness disturbed, convulsion and so on, when such symptoms arise, adequate treatment should be given such as correction of electrolytes. In the case of letting patients take drug at home, it is necessary to offer them guidance by referring to Important Basic precautions under Precautions.
Other adverse reactions: See Table 2.

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