Blopress Adverse Reactions

Treatment of Hypertension: In controlled clinical studies, adverse events were mild and transient and comparable to placebo. The overall incidence of adverse events showed no association with dose or age.
Withdrawals from treatment due to adverse events were similar with candesartan cilexetil (3.1%) and placebo (3.2%).
In a pooled analysis of clinical trial data, the following common (>1/100) adverse reactions with candesartan cilexetil were reported based on an incidence of adverse events with at least 1% higher than the incidence seen with placebo: Nervous System Disorders: Dizziness/vertigo, headache.
Infections and Infestations: Respiratory infection.
Laboratory Findings: In general, there were no clinically important influences of Blopress on routine laboratory variables. As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen. Increases in creatinine, urea or potassium and decrease in sodium have been observed.
Increases in S-GPT were reported as adverse events slightly more often with Blopress than the placebo (1.3% vs 0.5%). No routine monitoring of laboratory variables is usually necessary for patients receiving Blopress. However, in patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Treatment of Heart Failure: The adverse experience profile of Blopress in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. Adverse reactions commonly (>1/100, <1/10) seen were: Vascular Disorders: Hypotension.
Metabolism and Nutrition Disorders: Hyperkalaemia.
Renal and Urinary Disorders: Renal impairment.
Laboratory Findings: Increases in creatinine, urea and potassium. Periodic monitoring of serum creatinine and potassium is recommended.
Post Marketing: The following adverse reactions have been reported very rarely (<1/10,000) in post marketing experiences: Blood and Lymphatic System Disorders: Leukopenia, neutropenia and agranulocytosis.
Metabolism and Nutrition Disorders: Hyperkalaemia, hyponatraemia.
Nervous System Disorders: Dizziness, headache.
Gastrointestinal Disorders: Nausea.
Hepato-Biliary Disorders: Increased liver enzymes, abnormal hepatic function or hepatitis.
Skin and Subcutaneous Tissue Disorders: Angioedema, rash, urticaria, pruritus.
Musculoskeletal, Connective Tissue and Bone Disorders: Back pain, arthralgia, myalgia.
Renal and Urinary Disorders: Renal impairment, including renal failure in susceptible patients.