Candesartan Side Effects

Brand Names: Atacand

Please note - some side effects for Candesartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Candesartan - for the Consumer

Candesartan/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Candesartan/Hydrochlorothiazide:

Back pain; diarrhea; dizziness; lightheadedness, especially when sitting up or standing; nausea; numbness or tingling of the skin; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; decrease in sexual ability; depression; drowsiness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; decreased urination; hoarseness; muscle pain, tenderness, or cramps; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dry mouth; shortness of breath; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vomiting; yellowing of the skin or eyes.

Candesartan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Candesartan:

Back pain; dizziness; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); change in the amount of urine produced; chest pain; dark urine; difficulty swallowing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain or cramps; severe or persistent stomach pain (with or without nausea or vomiting); symptoms of low blood pressure (eg, fainting, lightheadedness, severe dizziness); unusual bruising or bleeding; yellowing of the eyes or skin.

Side Effects by Body System

General

In general, candesartan has been well tolerated in large, prospective, placebo-controlled clinical trials. Overall, the rates of withdrawal of therapy due to adverse events among treated versus placebo patients were 3.3% and 3.5%, respectively.

Nervous system

Nervous system side effects have been reported the most frequently. These have included headache (3%) and dizziness. Fatigue, vertigo, and paresthesias have been reported in at least 0.5% of patients.

Cardiovascular

Cardiovascular side effects including peripheral edema and chest pain have been reported in 1% of patients and at rates similar to placebo. Myocardial infarction and angina pectoris have been reported rarely. Hypotension (18.8% vs. 9.8% in placebo), tachycardia (0.5%), and palpitations (0.5%) have been reported. Rare cases of angioedema have also been reported.

Caution should be observed when initiating therapy in patients with heart failure. Patients with heart failure given candesartan commonly have some reduction in blood pressure. In the CHARM program, the incidence of hypotension leading to drug discontinuation in candesartan-treated patients was 4.1% compared with 2.0% in placebo-treated patients.

Respiratory

Respiratory side effects have included cough, but it has been less frequent with the use of candesartan or other angiotensin II antagonists (reported in approximately 1% of treated patients and placebo patients alike) than with angiotensin converting enzyme inhibitors. Bronchitis, coughing, sinusitis, pharyngitis, upper respiratory tract infection, and dyspnea have been reported in approximately 0.5% to 1.0% of patients. Upper respiratory tract infections have been reported among 6% of treated patients (compared with 4% placebo patients) in controlled clinical trials. These infections have included pharyngitis (2% vs. 1% of patients) and rhinitis (2% vs. 1% of patients). A cause-and-effect relationship is unlikely.

Candesartan did not significantly affect pulmonary function, bronchial hyperreactivity, or cough in patients with asthma.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, abdominal pain, and diarrhea have been reported in at least 1% of patients and at rates similar to placebo. Dyspepsia and gastroenteritis have been reported in 0.5% of patients. Alteration of taste sensitivity has also been associated with candesartan use.

Musculoskeletal

Musculoskeletal side effects have included back pain (3%), arthralgias (1%), and myalgias (0.5%). Rarely, rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Endocrine

Endocrinologic side effects have been reported rarely. These have included hyperuricemia, hyperglycemia, hypertriglyceridemia, and elevated plasma creatine phosphokinase in approximately 0.5% of patients.

Hematologic

Hematologic side effects including epistaxis has been reported in 0.5% of patients. Neutropenia, leukopenia, and agranulocytosis have been reported rarely. A causal relationship has not been established.

Psychiatric

Psychiatric side effects have been reported rarely. These have included anxiety, depression, and somnolence in approximately 0.5% of patients.

Dermatologic

Dermatologic side effects have been reported rarely. These have included rash or increased sweating in approximately 0.5% of patients. Psoriasis development or exacerbation has been reported. Pruritus and urticaria have been reported in postmarketing experience.

Genitourinary

Genitourinary side effects including hematuria has been reported in 0.5% of patients. A causal relationship has not been established.

Metabolic

Metabolic side effects have rarely included increased creatine phosphokinase, hyperglycemia, hypertriglyceridemia, hyperuricemia, hyperkalemia, and hyponatremia.

Hepatic

Hepatic side effects have included transient elevations of serum liver transaminases. At least one case of hepatotoxicity with icterus, hepatomegaly, and abnormal liver function tests has been reported.

Renal

Renal side effects including renal impairment and renal failure have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have been reported rarely. At least one case of acute nephritic syndrome with accompanying pruritic rash has been reported.

Other

Other side effects including asthenia and fever have been reported in approximately 0.5% of patients.

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