Unisia Adverse Reactions

Adverse reactions to Unisia, including abnormalities in laboratory data, were observed in 35 (11.6%) of 302 patients in the clinical study before approval.
Following adverse reactions were observed in either in the previously mentioned study or spontaneous reports of candesartan cilexetil or amlodipine besilate, and so on. If any adverse reaction is observed, appropriate measures should be taken eg, discontinuation of Unisia.
Clinically Significant Adverse Reactions (Frequency Unknown): Angioedema: Since angioedema manifested by facial, labial, glossal and laryngopharyngeal swellings may occur, patients should be closely observed. If any abnormality is observed, Unisia tablets should be discontinued, and appropriate measures taken.
Shock, Syncope or Unconsciousness: Since shock, syncope or unconsciousness due to lowering of blood pressure may occur, close observation should be made. If coldness, vomiting, unconsciousness are observed, appropriate measures should be taken immediately. Condition of the patients should be closely observed during administration of Unisia tablets, especially in patients on hemodialysis, those on strict dietary salt restriction, those under diuretic therapy, and those with heart failure.
Acute Renal Failure: Since acute renal failure may occur, patients should be closely observed. If any abnormality is observed, Unisia tablets should be discontinued, and appropriate measures taken.
Hyperkalemia: Since severe hyperkalemia may occur, patients should be closely observed. If any abnormality is observed, appropriate measures should immediately be taken.
Hepatic Dysfunction or Jaundice: Since hepatic dysfunction, including increased AST (GOT), ALT (GPT), γ-GTP or jaundice may occur, patients should be closely observed. If any abnormality is observed, Unisia should be discontinued, and appropriate measures taken.
Agranulocytosis, Decreased White Blood Cell: Since agranulocytosis and decreased white blood cell may occur, patients should be closely observed. If any abnormality is observed, Unisia tablets should be discontinued, and appropriate measures taken.
Rhabdomyolysis: Since rhabdomyolysis, which is characterized by muscle ache, weakness, increased CK (CPK), and increased blood and urinary myoglobin, may occur, patient should be closely observed. In such a case, administration of Unisia should be immediately discontinued, and appropriate measures taken.
Interstitial Pneumonia: Interstitial pneumonia with fever, coughing, dyspnea, abnormal chest X-ray may occur. In such a case, Unisia should be discontinued and appropriate measures eg, treatment with an adrenocortical hormone, should be taken.
Hypoglycemia: Since hypoglycemia may occur (liable to occur in patients on diabetic therapy), close observation should be made. If feeling of weakness or hunger, cold sweat, tremor of hands, decreased mental concentration, convulsions, disturbed consciousness are observed, Unisia should be discontinued, and appropriate measures taken.
Decreased Platelet Count: Since decreased platelet count may occur, patients should be closely observed. If any abnormality is observed, Unisia tablets should be discontinued, and appropriate measures taken.
Atrioventricular Block: Since atrioventricular block (initial symptoms: Bradycardia, dizziness) may occur, patients should be closely observed. If any abnormality is observed, Unisia tablets should be discontinued, and appropriate measures taken.
Other Adverse Reactions: (See Table 5).

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