Candekern Tác dụng không mong muốn

Treatment of Hypertension: In controlled clinical studies, adverse reactions were mild and transient. 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 of hypertensive patients, adverse reactions with candesartan cilexetil were defined based on an incidence of adverse events with candesartan cilexetil at least 1% higher than the incidence seen with placebo. By this definition, the most commonly reported adverse reactions were dizziness/vertigo, headache and respiratory infection.
The table below presents adverse reactions from clinical trials and post-marketing experience.
The frequencies used in the tables throughout this section are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). (See Table 1.)


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Laboratory findings: In general, there were no clinically important influences of Candesartan on routine laboratory variables. As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen. No routine monitoring of laboratory variables is usually necessary for patients receiving Candesartan. 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 Candesartan in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the CHARM clinical programme, comparing Candesartan in doses up to 32 mg (n=3,803) to placebo (n=3,796), 21.0% of the candesartan cilexetil group and 16.1% of the placebo group discontinued treatment because of adverse events. The most commonly reported adverse reactions were hyperkalaemia, hypotension and renal impairment. These events were more common in patients over 70 years of age, diabetics, or subjects who received other medicinal products which affect the renin-angiotensin-aldosterone system, in particular an ACE inhibitor and/or spironolactone.
The table as follow presents adverse reactions from clinical trials and post-marketing experience. (See Table 2.)


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Laboratory findings: Hyperkalaemia and renal impairment are common in patients treated with Candesartan for the indication of heart failure. Periodic monitoring of serum creatinine and potassium is recommended (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.