Clinically significant adverse reactions: Shock and Anaphylactic shock (frequency unknown): Since shock and anaphylactic shock (blood pressure decreased, loss of consciousness, dyspnoea, cardio-respiratory arrest, flushing, face oedema, etc.) may occur, patients should be carefully observed. In the event of any abnormality, administration should be discontinued immediately and appropriate measures should be taken.
Anaphylactoid reaction (frequency unknown): Since anaphylactoid reaction (dyspnoea, flushing, face oedema, etc.) may occur, patients should be carefully observed. In the event of any abnormality, administration should be discontinued immediately and appropriate measures should be taken.
Pseudoaldosteronism (frequency unknown): Since after increased dosage or long-term administration, there is a concern about occurrence of pseudoaldosteronism such as severe hypokalaemia, high incidence of hypokalaemia, increased blood pressure, sodium retention, fluid retention, oedema, increased weight and the like, patients should be carefully observed (including determination of serum potassium level). In the event of any abnormality, administration should be discontinued.
Feelings of weakness and muscular weakness might be caused by hypokalaemia.
Other adverse reactions: The symptoms indicated as follows may appear. Along with increase in dose, decrease in serum potassium level and increasing tendency of elevation in blood pressure are observed. (See Table 6.)
Click on icon to see table/diagram/image
View ADR Monitoring Form