Atacand HCT (Candesartan Cilexetil / Hydrochlorothiazide) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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.

Candesartan Cilexetil

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.

Hydrochlorothiazide

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.

REPORTS OF SUSPECTED ATACAND HCT SIDE EFFECTS / ADVERSE REACTIONS

Possible Atacand HCT side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from Germany on 2011-10-03

Patient: 58 year old female

Reactions: Neutropenia, Leukopenia

Suspect drug(s):
Metoprolol Succinate
    Dosage: daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2000-01-01
    End date: 2004-01-01

Atacand HCT
    Dosage: 16/12.5 mg daily
    Administration route: Oral
    Start date: 2009-09-01

Atacand HCT
    Dosage: 16/12.5 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-01-01
    End date: 2009-03-01

Metoprolol Succinate
    Dosage: daily beloc zok mite
    Administration route: Oral
    Start date: 2004-01-01

Possible Atacand HCT side effects / adverse reactions in 79 year old female

Reported by a consumer/non-health professional from Brazil on 2011-10-04

Patient: 79 year old female

Reactions: Thrombosis, Circumstance or Information Capable of Leading TO Medication Error, Depression, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Suspect drug(s):
Atacand HCT
    Dosage: 16/12.5 mg once daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-01-01

Omeprazole
    Administration route: Oral
    Indication: Hiatus Hernia

Atacand HCT
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Citalopram Hydrobromide

Possible Atacand HCT side effects / adverse reactions in 81 year old male

Reported by a consumer/non-health professional from Brazil on 2011-10-04

Patient: 81 year old male weighing 95.0 kg (209.0 pounds)

Reactions: Blood Pressure Increased, Cardiac Failure, Drug Ineffective, Oedema Peripheral

Suspect drug(s):
Omeprazole
    Dosage: daily
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2001-01-01

Atacand HCT
    Dosage: 16+12.5 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-09-01

Atacand HCT
    Dosage: 16+12.5 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2006-01-01
    End date: 2011-09-01

Atacand
    Administration route: Oral
    Indication: Hypertension
    Start date: 2001-01-01
    End date: 2006-01-01

Other drugs received by patient: Simvastatin; Somalgin Cardio; Primide; Duomo; Citalopram Hydrobromide; Bisoprolol Fumarate; Lasix; Depakene