Adverse reactions were observed in 27 (0.61%) out of 4,451 cases included in the double-blind studies conducted for the indication (improvement of abnormal hepatic function in chronic liver diseases), the dose comparison study and the post-marketing surveillance conducted for the use in chronic liver diseases. Notable ones were serum potassium decreased in 13 cases (0.29%), blood pressure increased in 5 cases (0.11%) and upper abdominal discomfort in 3 cases (0.07%).
Clinically significant adverse reactions
1) Shock and Anaphylactic shock (frequency unknown): Since shock and anaphylactic shock (blood pressure decreased, loss of consciousness, dyspnoea, 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.
2) 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.
3) 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 below may appear. Along with increase in dose, decrease in serum potassium level and increasing tendency of elevation in blood pressure are observed.
| 0.1% to less than 5 % |
Less than 0.1% | Frequency unknown | |
| Hypersensitivity | Rash | Urticaria, itching | |
| Body fluid, Electrolytes | Decrease in serum potassium |
Oedema | |
| Cardiovascular | Increase in blood pressure |
||
| Gastrointestinal | Upper abdominal discomfort | Nausea, vomiting | |
| Respiratory | Cough | ||
| Eyes | Transient abnormal vision (filmy vision, flash vision, etc.) | ||
| Others | General malaise, myalgia, dysaesthesia (numbness, tingling, sensation, etc.), pyrexia, hyperventilation syndrome (hot feeling in shoulder, cold extremities, cold sweat, thirst, palpitations), urine sugar positive | Headache, hot feeling, feeling ill |
| Reporting of suspected adverse drug reactions |
| Please contact: |
| HI-Eisai Pharmaceutical, Inc. |
| +63 2 88875837 / +63 2 88875160 / +63 9088672236 |
| Or Report to FDA Philippines: www.fda.gov.ph |