Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Candesartan Cilexetil - Hydrochlorothiazide Candesartan cilexetil and hydrochlorothiazide tablets have been evaluated for safety in more than 2800 patients treated for hypertension.
More than 750 of these patients were studied for at least six months and more than 500 patients were treated for at least one year.
Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall incidence of adverse events reported with candesartan cilexetil and hydrochlorothiazide tablets was comparable to placebo.
The overall frequency of adverse experiences was not related to dose, age, gender, or race.
In placebo-controlled trials that included 1089 patients treated with various combinations of candesartan cilexetil (doses of 2-32 mg) and hydrochlorothiazide (doses of 6.25-25 mg) and 592 patients treated with placebo, adverse events, whether or not attributed to treatment, occurring in greater than 2% of patients treated with candesartan cilexetil and hydrochlorothiazide tablets and that were more frequent for candesartan cilexetil and hydrochlorothiazide tablets than placebo were: Respiratory System Disorder: upper respiratory tract infection (3.6% vs 3.0%);
Body as a Whole: back pain (3.3% vs 2.4%);
influenza-like symptoms (2.5% vs 1.9%);
Central/Peripheral Nervous System: dizziness (2.9% vs 1.2%).
Post-Marketing Experience The following have been very rarely reported in post-marketing experience with candesartan cilexetil: Digestive: Abnormal hepatic function and hepatitis.
WARNINGS Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue candesartan cilexetil and hydrochlorothiazide tablets as soon as possible.
These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy.
Like all medications, Candesartan Cilexetil And Hydrochlorothiazide can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: