Blopress Plus Adverse Reactions

Candesartan Cilexetil-Hydrochlorothiazide: Blopress Plus has been evaluated for safety in >2800 patients treated for hypertension. More than 750 of these patients were studied for at least 6 months and >500 patients were treated for at least 1 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 Blopress Plus 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 >2% of patients treated with Blopress Plus and that were more frequent for Blopress Plus than placebo were: Respiratory System Disorder: Upper respiratory tract infections (3.6% vs 3%).
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 >2% [2.9% in patients treated with Blopress Plus but was less frequent than the rate in patients treated with placebo (5.2%)].
Other adverse events have been reported whether or not attributed to treatment, with an incidence of ≥0.5% from >2800 patients worldwide treated with Blopress Plus included: Body as a Whole: Inflicted injury, fatigue, pain, peripheral oedema, 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: Hyperuricaemia, hyperglycemia, hypokalemia, increased BUN, increased creatinine phosphokinase.
Urinary System Disorder: Urinary tract infection, hematuria, cystitis.
Liver/Biliary System Disorders: Abnormal hepatic function, increased transaminase levels.
Heart Rate and Rhythm Disorders: Tachycardia, palpitation, extrasystoles, bradycardia.
Psychiatric Disorders: Depression, insomnia, anxiety.
Cardiovascular Disorders: Abnormal ECG.
Skin and Appendages Disorders: Eczema, increased sweating, pruritus, dermatitis, rash.
Platelet/Blood Clotting Disorders: Epistaxis.
Resistance Mechanism Disorders: Infection, viral infection.
Vision Disorder: 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 without regard to causality are as follows: Body as a Whole: Fever.
Metabolic and Nutritional Disorders: Hypertriglyceridemia.
Psychiatric Disorders: Somnolence.
Urinary System Disorders: Albuminuria.
Hydrochlorothiazide: Other adverse experiences that have been reported without regard to causality are as follows: 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 Finding: In controlled clinical trials, clinically important changes in standard laboratory parameter were rarely associated with the administration of Blopress Plus.
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen (BUN) and serum creatinine was observed infrequently. One patient discontinued Blopress Plus due to increased BUN. No patient 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, respectively) were observed in patients treated with Blopress Plus, but were rarely of clinical importance.
Potassium: A small decrease (mean decrease of 0.1 mEq/L) was observed in patients treated with Blopress Plus. In placebo-controlled trials, hypokalemia was reported in 0.4% of patients treated with Blopress Plus as compared to 1% 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.