Hextan/Hextan Plus Adverse Reactions

Hextan: General: Facial edema, fever, orthostatic effects, syncope.
Cardiovascular: Angina pectoris, second degree AV block, CVA, hypotension, myocardial infarction, arrhythmias including atrial fibrillation, palpitation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation.
Digestive: Anorexia, constipation, dental pain, dry mouth, flatulence, gastritis, vomiting.
Hematologic: Anemia.
Metabolic: Gout.
Musculoskeletal: Arm pain, hip pain, joint swelling, knee pain, musculoskeletal pain, shoulder pain, stiffness, arthralgia, arthritis, fibromyalgia, muscle weakness.
Nervous System/Psychiatric: Anxiety, anxiety disorder, ataxia, confusion, depression, dream abnormality, hypesthesia, decreased libido, memory disorder, sleep disorder, somnolence, tremor, vertigo.
Respiratory: Dyspnea, bronchitis, pharyngeal discomfort, epistaxis, rhinitis, respiratory congestion.
Skin: alopecia, dermatitis, dry skin, ecchymosis, erythema, flushing, photosensitivity, pruritis, rash, sweating, urticaria.
Special senses: Blurred vision, burning/stinging in the eye, conjunctivitis, taste perversion, tinnitus, decrease in visual acuity.
Urogenital: impotence, nocturia, urinary frequency, urinary tract infection.
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 0.1 per cent of patients with essential hypertension treated with losartan potassium alone.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.11 grams percent 0.09 volume percent, respectively) occurred frequently in patients treated with losartan potassium alone, but were rarely of clinical importance. No patients were discontinued due to anemia.
Liver Function Tests: Occasional elevations of liver enzymes and/or other serum bilirubin have occurred.
Hextan Plus: The adverse reactions below are classified where appropriate by system organ class and frequency according to the following convention: Very common: ≥ 1/10; Common: ≥ 1/100 to < 1/10; Uncommon: ≥ 1/1,000 to ≤ 1/100; Rare: ≥ 1/10,000 to ≤ 1/1,000; Very rare: ≤ 1/10,000; Not known: (cannot be estimated from the available data).
In clinical trials with losartan potassium salt and hydrochlorothiazide, no adverse reactions peculiar to this combination of substances were observed. The adverse reactions were restricted to those which were formerly observed with losartan potassium salt and/or hydrochlorothiazide.
In controlled clinical trials for essential hypertension, dizziness was the only adverse experience reported as substance related that occurred with an incidence greater than placebo in 1% or more of patients treated with losartan and hydrochlorothiazide.
Next to these effects, there are further adverse reactions reported after the introduction of the product to the market as: Hepato-biliary disorders: Rare: Hepatitis.
Investigations: Rare: Hyperkalaemia, elevation of ALT.
Additional adverse reactions that have been seen with one of the individual components and may be potential adverse reactions with losartan potassium/ hydrochlorothiazide are the following: Losartan: Blood and lymphatic system disorders: Uncommon: Anaemia, Henoch-Schönlein purpura, ecchymosis, haemolysis.
Immune system disorders: Rare: Anaphylactic reactions, angioedema, urticaria.
Metabolism and nutrition disorders: Uncommon: Anorexia, gout.
Psychiatric disorders: Common: Insomnia.
Uncommon: Anxiety, anxiety disorder, panic disorder, confusion, depression, abnormal dreams, sleep disorder, somnolence, memory impairment.
Nervous system disorders: Common: Headache, dizziness.
Uncommon: Nervousness, paraesthesia, peripheral neuropathy, tremor, migraine, syncope.
Eye disorders: Uncommon: Blurred vision, burning/stinging in the eye, conjunctivitis, decrease in visual acuity.
Ear and labyrinth disorders: Uncommon: Vertigo, tinnitus.
Cardiac disorders: Uncommon: Hypotension, orthostatic hypotension, sternalgia, angina pectoris, grade II-AV block, cerebrovascular event, myocardial infarction, palpitation, arrhythmias (atrial fibrillations, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation).
Vascular disorders: Uncommon: Vasculitis.
Respiratory, thoracic and mediastinal disorders: Common: Cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder.
Uncommon: Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion.
Gastrointestinal disorders: Common: Abdominal pain, nausea, diarrhoea, dyspepsia.
Uncommon: Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting.
Hepato-biliary disorders: Not known: Liver function abnormalities.
Skin and subcutaneous tissue disorders: Uncommon: Alopecia, dermatitis, dry skin, erythema, flushing, photosensitivity, pruritus, rash, urticaria, sweating.
Musculoskeletal and connective tissue disorders: Common: Muscle cramp, back pain, leg pain, myalgia.
Uncommon: Arm pain, joint swelling, knee pain, musculoskeletal pain, shoulder pain, stiffness, arthralgia, arthritis, coxalgia, fibromyalgia, muscle weakness.
Not known: Rhabdomyolysis.
Renal and urinary disorders: Uncommon: Nocturia, urinary frequency, urinary tract infection.
Reproductive system and breast disorders: Uncommon: Decreased libido, impotence.
General disorders and administration site conditions: Common: Asthenia, fatigue, chest pain.
Uncommon: Facial oedema, fever.
Investigations: Common: Hyperkalaemia, mild reduction of haematocrit and haemoglobin.
Uncommon: Mild increase in urea and creatinine serum levels.
Very rare: Increase in hepatic enzymes and bilirubin.
Hydrochlorothiazide: Blood and lymphatic system disorders: Uncommon: Agranulocytosis, aplastic anaemia, haemolytic anaemia, leukopenia, purpura, thrombocytopenia.
Immune system disorders: Rare: Anaphylactic reaction.
Metabolism and nutrition disorders: Uncommon: Anorexia, hyperglycaemia, hyperuricaemia, hypokalaemia, hyponatraemia.
Psychiatric disorders: Uncommon: Insomnia.
Nervous system disorders: Common: Cephalalgia.
Eye disorders: Uncommon: Transient blurred vision, xanthopsia.
Vascular disorders: Uncommon: Necrotizing angiitis (vasculitis, cutaneous vasculitis).
Respiratory, thoracic and mediastinal disorders: Uncommon: Respiratory distress including pneumonitis and pulmonary oedema.
Gastrointestinal disorders: Uncommon: Sialoadenitis, spasms, stomach irritation, nausea, vomiting, diarrhoea, constipation.
Hepato-biliary disorders: Uncommon: Icterus (intrahepatic cholestatis), pancreatitis.
Skin and subcutaneous tissue disorders: Uncommon: Photosensitivity, urticaria, toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: Uncommon: Muscle cramps. Renal and urinary disorders: Uncommon: Glycosuria, interstitial nephritis, renal dysfunction, renal failure.
General disorders and administration site conditions: Uncommon: Fever, dizziness.