Atacand HCT Side Effects

Please note - some side effects for Atacand HCT 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 HCT - 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.

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 HCT Side Effects - for the Professional

Atacand HCT

Candesartan Cilexetil-Hydrochlorothiazide

Atacand HCT has 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 Atacand HCT 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 Atacand HCT and that were more frequent for Atacand HCT 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%).

The frequency of headache was greater than 2% (2.9%) in patients treated with Atacand HCT but was less frequent than the rate in patients treated with placebo (5.2%).

Other adverse events that have been reported, whether or not attributed to treatment, with an incidence of 0.5% or greater from the more than 2800 patients worldwide treated with Atacand HCT included:Body as a Whole: inflicted injury, fatigue, pain, chest pain, peripheral edema, asthenia; Central and Peripheral Nervous System: vertigo, paresthesia, hypesthesia; Respiratory System Disorders: bronchitis, sinusitis, pharyngitis, coughing, rhinitis, dyspnea; Musculoskeletal System Disorders: arthralgia, myalgia, arthrosis, arthritis, leg cramps, sciatica; Gastrointestinal System Disorders: nausea, abdominal pain, diarrhea, dyspepsia, gastritis, gastroenteritis, vomiting; Metabolic and Nutritional Disorders: hyperuricemia, hyperglycemia, hypokalemia, increased BUN, creatine phosphokinase increased; Urinary System Disorders: urinary tract infection, hematuria, cystitis; Liver/Biliary System Disorders: hepatic function abnormal, increased transaminase levels; Heart Rate and Rhythm Disorders: tachycardia, palpitation, extrasystoles, bradycardia; Psychiatric Disorders: depression, insomnia, anxiety; Cardiovascular Disorders: ECG abnormal; Skin and Appendages Disorders: eczema, sweating increased, pruritus, dermatitis, rash; Platelet/Bleeding-Clotting Disorders: epistaxis; Resistance Mechanism Disorders: infection, viral infection; Vision Disorders: conjunctivitis; Hearing and Vestibular Disorders: tinnitus.

Reported events seen less frequently than 0.5% included angina pectoris, myocardial infarction and angioedema.

Other adverse experiences that have been reported with candesartan cilexetil, without regard to causality, were: Body as a Whole: fever; Metabolic and Nutritional Disorders: hypertriglyceridemia; Psychiatric Disorders: somnolence; Urinary System Disorders: albuminuria.

Post-Marketing Experience

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

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.

Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body As A Whole: weakness; Cardiovascular: hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs); Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, constipation, gastric irritation, anorexia; Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, urticaria, purpura; Metabolic: electrolyte imbalance, glycosuria; Musculoskeletal: muscle spasm; Nervous System/Psychiatric: restlessness;Renal: renal failure, renal dysfunction, interstitial nephritis; Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: transient blurred vision, xanthopsia; Urogenital: impotence.

Laboratory Test Findings

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

Creatinine, Blood Urea Nitrogen— Minor increases in blood urea nitrogen (BUN) and serum creatinine were observed infrequently. One patient was discontinued from Atacand HCT due to increased BUN. No patient was discontinued due to an increase in serum creatinine.

Hemoglobin and Hematocrit—Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.2 g/dL and 0.4 volume percent, respectively) were observed in patients treated with Atacand HCT, but were rarely of clinical importance.

Potassium— A small decrease (mean decrease of 0.1 mEq/L) was observed in patients treated with Atacand HCT. In placebo-controlled trials, hypokalemia was reported in 0.4% of patients treated with Atacand HCT as compared to 1.0% of patients treated with hydrochlorothiazide or 0.2% of patients treated with placebo.

Liver Function Tests—Occasional elevations of liver enzymes and/or serum bilirubin have occurred.

Side Effects by Body System

Respiratory

Respiratory side effects associated with candesartan-hydrochlorothiazide have included upper respiratory tract infection (3.6%), bronchitis, sinusitis, pharyngitis, coughing, rhinitis, and dyspnea. Respiratory distress, pneumonitis, and pulmonary edema have been reported with the use of HCTZ.

Nervous system

Nervous system side effects associated with candesartan-hydrochlorothiazide have included dizziness (2.9%), vertigo, paresthesia, and hypesthesia. Restlessness has been reported with the use of HCTZ.

Musculoskeletal

Musculoskeletal side effects associated with candesartan-hydrochlorothiazide have included arthralgia, myalgia, arthrosis, arthritis, leg cramps, and sciatica. Muscle spasm has been reported with the use HCTZ.

Musculoskeletal side effects associated with angiotensin II receptor blockers including rare reports of rhabdomyolysis have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects associated with candesartan-hydrochlorothiazide have included nausea, abdominal pain, diarrhea, dyspepsia, gastritis, gastroenteritis, and vomiting. Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, constipation, gastric irritation, and anorexia have been reported with the use of HCTZ.

Metabolic

Metabolic side effects associated with candesartan-hydrochlorothiazide have included hyperuricemia, hyperglycemia, hypokalemia, increased BUN, and increased creatine phosphokinase. Electrolyte imbalance and glycosuria have been reported with the use of HCTZ.

Metabolic side effects associated with candesartan have included hypertriglyceridemia.

Hepatic

Hepatic side effects associated with candesartan-hydrochlorothiazide have included abnormal hepatic function, increased transaminase levels, and hepatitis.

Cardiovascular

Cardiovascular side effects associated with candesartan-hydrochlorothiazide have included tachycardia, palpitation, extrasystoles, bradycardia, and ECG abnormalities. Angina pectoris, myocardial infarction, and angioedema have been reported in less than 0.5% of patients. Hypotension, orthostatic hypotension, and necrotizing angiitis (vasculitis and cutaneous vasculitis) have been reported with the use of HCTZ.

Psychiatric

Psychiatric side effects associated with candesartan-hydrochlorothiazide have included depression, insomnia, and anxiety. Somnolence has been reported with the use of candesartan.

Dermatologic

Dermatologic side effects associated with candesartan-hydrochlorothiazide have included eczema, increased sweating, pruritus, and dermatitis. Photosensitivity, urticaria, purpura, exfoliative dermatitis, toxic epidermal necrolysis, and alopecia have been reported with the use of HCTZ.

Hematologic

Hematologic side effects associated with candesartan-hydrochlorothiazide have included epistaxis. Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, and thrombocytopenia have been reported with the use of HCTZ.

Immunologic

Immunologic side effects associated with candesartan-hydrochlorothiazide have included infection and viral infection.

Ocular

Ocular side effects associated with candesartan-hydrochlorothiazide have included conjunctivitis. Transient blurred vision and xanthopsia have been reported with the use of HCTZ.

Other

Other side effects associated with candesartan-hydrochlorothiazide have included back pain (3.3%), influenza-like symptoms fatigue, pain, peripheral edema, asthenia fever, and tinnitus. Weakness has been reported with the use of HCTZ.

Renal

Renal side effects associated with candesartan-hydrochlorothiazide have included urinary tract infection, hematuria, and cystitis. Renal failure, renal dysfunction, and interstitial nephritis have been reported with the use of HCTZ.

Renal side effects associated with candesartan have included albuminuria.

Genitourinary

Genitourinary side effects associated with HCTZ have included impotence.

Hypersensitivity

Hypersensitivity side effects associated with HCTZ have included erythema multiforme and Stevens-Johnson syndrome.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.