Adverse reactions were reported in 22 of 1,244 patients (1.77%), and abnormal laboratory test values were reported in 82 (6.59%). (At the time of approval.)
Clinically significant adverse reactions: Shock: It has been reported that anaphylactic reactions or shock occurred with analogue compounds (omeprazole and lansoprazole). If any such abnormality is observed, treatment should be discontinued and appropriate measures taken.
Agranulocytosis, thrombocytopenia and pancytopenia: Agranulocytosis (incidence unknown), thrombocytopenia (5% > ≥0.1%) or pancytopenia (incidence unknown) may occur. If any such abnormality is observed, treatment should be discontinued and appropriate measures taken. It has been reported that hemolytic anemia occurred with analogous compounds (omeprazole and lansoprazole).
Hepatic function disorders: Hepatic function disorders (5% > ≥10%) or jaundice (incidence unknown) may occur. If any such abnormality is observed, treatment should be discontinued and appropriate measures taken.
Interstitial pneumonia: Interstitial pneumonia (incidence unknown) may occur. If symptoms such as fever, coughing, dyspnoea and abnormal lung sounds (crepitations) occur, thoracic radiography or other examination should be performed immediately. Administration should be discontinued, and appropriate measures should be taken, such as treatment with cortical steroid hormones.
Visual disturbance: Visual disturbance has been reported with an analogue compound (omeprazole).
Clostridium difficile associated diarrhea.
Vitamin B12 Deficiency.
Other adverse reactions: See Table 9.
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Post-Marketing Adverse Events: Additional adverse events reported from worldwide marketing experience with sodium rabeprazole are: sudden death, coma and hyperammonemia, jaundice, rhabdomyolysis, disorientation and delirium, bullous and other drug eruptions of the skin, interstitial pneumonia, interstitial nephritis, and TSH elevations. In most instances, the relationship to sodium rabeprazole was unclear. In addition, agranulocytosis, hemolytic anemia, leukopenia, pancytopenia and thrombocytopenia have been reported. Increases in prothrombin time/INR in patients treated with concomitant warfarin have been reported.