Side Effects > Atacand

Atacand Side Effects

Please note - some side effects for Atacand 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 Atacand - for the Consumer

Atacand HCT

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 Atacand HCT:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Atacand HCT:

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.

Atacand

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 Atacand:

Back pain; dizziness; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur when using Atacand:

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.

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Atacand Side Effects - for the Professional

Atacand

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Hypertension

Atacand has been evaluated for safety in more than 3600 patients/subjects, including more than 3200 patients treated for hypertension. About 600 of these patients were studied for at least 6 months and about 200 for at least 1 year. In general, treatment with Atacand was well tolerated. The overall incidence of adverse events reported with Atacand was similar to placebo.

The rate of withdrawals due to adverse events in all trials in patients (7510 total) was 3.3% (ie, 108 of 3260) of patients treated with Atacand as monotherapy and 3.5% (ie, 39 of 1106) of patients treated with placebo. In placebo-controlled trials, discontinuation of therapy due to clinical adverse events occurred in 2.4% (ie, 57 of 2350) of patients treated with Atacand and 3.4% (ie, 35 of 1027) of patients treated with placebo.

The most common reasons for discontinuation of therapy with Atacand were headache (0.6%) and dizziness (0.3%).

The adverse events that occurred in placebo-controlled clinical trials in at least 1% of patients treated with Atacand and at a higher incidence in candesartan cilexetil (n = 2350) than placebo (n = 1027) patients included back pain (3% vs. 2%), dizziness (4% vs. 3%), upper respiratory tract infection (6% vs. 4%), pharyngitis (2% vs. 1%), and rhinitis (2% vs. 1%).

The following adverse events occurred in placebo-controlled clinical trials at a more than 1% rate but at about the same or greater incidence in patients receiving placebo compared to Atacand: fatigue, peripheral edema, chest pain, headache, bronchitis, coughing, sinusitis, nausea, abdominal pain, diarrhea, vomiting, arthralgia, albuminuria.

Other potentially important adverse events that have been reported, whether or not attributed to treatment, with an incidence of 0.5% or greater from the 3260 patients worldwide treated in clinical trials with Atacand are listed below. It cannot be determined whether these events were causally related to Atacand. Body as a Whole: asthenia, fever; Central and Peripheral Nervous System: paresthesia, vertigo; Gastrointestinal System Disorder: dyspepsia, gastroenteritis; Heart Rate and Rhythm Disorders: tachycardia, palpitation; Metabolic and Nutritional Disorders: creatine phosphokinase increased, hyperglycemia, hypertriglyceridemia, hyperuricemia; Musculoskeletal System Disorders: myalgia; Platelet/Bleeding-Clotting Disorders: epistaxis; Psychiatric Disorders: anxiety, depression, somnolence; Respiratory System Disorders: dyspnea; Skin and Appendages Disorders: rash, sweating increased; Urinary System Disorders: hematuria.

Other reported events seen less frequently included angina pectoris, myocardial infarction, and angioedema.

Adverse events occurred at about the same rates in men and women, older and younger patients, and black and non-black patients.

Pediatric Hypertension

Among children in clinical studies, 1 in 93 children age 1 to < 6 and 3 in 240 age 6 to < 17 experienced worsening renal disease. The association between candesartan and exacerbation of the underlying condition could not be excluded.

Heart Failure

The adverse event profile of Atacand in adult heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the CHARM program, comparing Atacand in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21.0% of patients discontinued Atacand for adverse events vs. 16.1% of placebo patients.

6.2 Postmarketing Experience

The following adverse reactions were identified during post-approval use of Atacand. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following have been very rarely reported in post-marketing experience:

Digestive: Abnormal hepatic function and hepatitis.

Hematologic: Neutropenia, leukopenia, and agranulocytosis.

Metabolic and Nutritional Disorders: hyperkalemia, hyponatremia.

Renal: renal impairment, renal failure.

Skin and Appendages Disorders: Pruritus and urticaria.

Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

6.3 Laboratory Test Findings

Hypertension

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with the administration of Atacand.

Creatinine, Blood Urea Nitrogen

Minor increases in blood urea nitrogen (BUN) and serum creatinine were observed infrequently.

Hyperuricemia

Hyperuricemia was rarely found (19 or 0.6% of 3260 patients treated with Atacand and 5 or 0.5% of 1106 patients treated with placebo).

Hemoglobin and Hematocrit

Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.2 grams/dL and 0.5 volume percent, respectively) were observed in patients treated with Atacand alone but were rarely of clinical importance. Anemia, leukopenia, and thrombocytopenia were associated with withdrawal of one patient each from clinical trials.

Potassium

A small increase (mean increase of 0.1 mEq/L) was observed in patients treated with Atacand alone but was rarely of clinical importance. One patient from a congestive heart failure trial was withdrawn for hyperkalemia (serum potassium = 7.5 mEq/L). This patient was also receiving spironolactone [see WARNINGS AND PRECAUTIONS (5.6)].

Liver Function Tests

Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients assigned to Atacand in clinical trials were withdrawn because of abnormal liver chemistries. All had elevated transaminases. Two had mildly elevated total bilirubin, but one of these patients was diagnosed with Hepatitis A.

Heart Failure

In the CHARM program, small increases in serum creatinine (mean increase 0.2 mg/dL in candesartan-treated patients and 0.1 mg/dL in placebo-treated patients) and serum potassium (mean increase 0.15 mEq/L in Atacand-treated patients and 0.02 mEq/L in placebo-treated patients), and small decreases in hemoglobin (mean decrease 0.5 gm/dL in Atacand-treated patients and 0.3 gm/dL in placebo-treated patients) and hematocrit (mean decrease 1.6% in Atacand-treated patients and 0.9% in placebo-treated patients) were observed.

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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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