Classification of the frequency of development of side effects of the World Health Organization (WHO):
very often ≥ 1/10
often from ≥ 1/100 to <1/10
infrequently from ≥ 1/1000 to <1/100
rarely from ≥ 1/10000 to <1/1000
very rarely <1/10000
frequency is unknown - can not be estimated from the available data.
When a combination of valsartan / hydrochlorothiazide
Disorders from the metabolism and nutrition:
infrequently: dehydration.
Impaired nervous system:
often: headache;
infrequently: paresthesia;
very rarely: dizziness;
frequency unknown: faint.
Disorders from the side of the organ of vision:
infrequently: decreased visual acuity.
Hearing disorders and labyrinthine disturbances:
infrequently: noise in the ears.
Vascular disorders:
infrequent: marked decrease in blood pressure, peripheral edema.
Disturbances from the respiratory system, chest and mediastinal organs:
infrequently: cough;
frequency unknown: noncardiogenic pulmonary edema.
Disorders from the gastrointestinal tract:
infrequently: nausea;
very rarely: diarrhea.
Disturbances from the musculoskeletal and connective tissue:
infrequently: myalgia;
very rarely: arthralgia.
Disorders from the kidneys and urinary tract:
frequency unknown: impaired renal function.
General disorders and disorders at the site of administration:
infrequently: increased fatigue.
Laboratory and instrumental data:
frequency is unknown: increased serum uric acid concentration, increased serum bilirubin concentration, increased serum creatinine concentration, hyponatremia, hypokalemia, neutropenia, increased residual urea nitrogen concentration in blood serum.
When studying the clinical use of a fixed combination of valsartan / hydrochlorothiazide in patients with AH, the following adverse events (AEs) were observed without apparent association with the drug: abdominal pain, upper abdominal pain, anxiety, arthritis, asthenia, back pain, bronchitis including acute), chest pain, postural dizziness, dyspepsia, dyspnea, dryness of the oral mucosa, nosebleeds, erectile dysfunction, gastroenteritis, headache, increased sweating, hypoesthesia, influenza-like soy insomnia, sprain, muscle spasms, muscle hypertonus, nasal congestion, nasopharyngitis, nausea, neck pain, peripheral edema, otitis media, pain in the extremities, palpitations, pain in the larynx and pharynx, pyrexia, pollakiuria, hyperthermia, sinusitis , drowsiness, upper respiratory tract infections, urinary tract infections, vertigo, viral infections, visual impairment.
With the use of the combination valsartan / hydrochlorothiazide, the occurrence of AEs that occur both with valsartan and HCTZ in monotherapy and not detected in clinical trials is possible.
When valsartan is used
Violations from the blood and lymphatic system:
the frequency is unknown: a decrease in hemoglobin, a decrease in hematocrit, thrombocytopenia.
Immune system disorders:
frequency unknown: hypersensitivity reactions / allergic reactions, including serum sickness.
Disorders from the metabolism and nutrition:
frequency is unknown: increased serum potassium, hyponatremia.
Hearing disorders and labyrinthine disturbances:
infrequently: vertigo.
Vascular disorders:
frequency unknown: vasculitis.
Disorders from the gastrointestinal tract:
infrequently: pain in the abdomen.
Disorders from the liver and bile ducts:
frequency is unknown: increased activity of "liver" enzymes.
Disturbances from the skin and subcutaneous tissues:
frequency unknown: angioedema, skin rash, skin itching, bullous dermatitis.
Disorders from the kidneys and urinary tract:
frequency unknown: renal failure.
The following AEs were observed in the study of the clinical use of valsartan in patients with AH irrespective of their causal relationship withusing valsartan: arthralgia, asthenia, back pain, diarrhea, dizziness, headache, insomnia, decreased libido, nausea, edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infection.
With the use of thiazide diuretics, including HCTZ
Violations from the blood and lymphatic system:
rarely: thrombocytopenia, sometimes with purpura;
very rare: agranulocytosis, inhibition of bone marrow hematopoiesis, hemolytic anemia, leukopenia;
frequency unknown: aplastic anemia.
Immune system disorders:
very rarely: hypersensitivity reactions.
Disorders from the metabolism and nutrition:
very often: hypokalemia, increase in the concentration of lipids in the blood plasma (especially against the background of high doses of HCTZ);
often: hyponatremia, hypomagnesemia, hyperuricemia;
rarely: hypercalcemia, hyperglycemia, glucosuria and worsening of SD;
Very rarely: hypochloraemic alkalosis.
Disorders of the psyche:
rarely: sleep disturbance, depression.
Impaired nervous system:
rarely: headache, dizziness, paresthesia.
Disorders from the side of the organ of vision:
rarely: visual impairment (especially in the first few weeks of treatment);
frequency unknown: acute attack of angle-closure glaucoma.
Heart Disease:
rarely: arrhythmias.
Vascular disorders:
often: orthostatic hypotension (may be intensified with simultaneous use with ethanol, sedatives or anesthetics).
Disturbances from the respiratory system, chest and mediastinal organs:
very rarely: respiratory distress syndrome, including pulmonary edema and pneumonitis.
Disorders from the digestive system:
often: decreased appetite, mild nausea and vomiting;
rarely: abdominal discomfort, constipation, diarrhea;
very rarely: pancreatitis.
Disorders from the liver and bile ducts:
rarely: intrahepatic cholestasis or jaundice.
Disorders from the kidneys and urinary tract:
frequency unknown: impaired renal function, acute renal failure.
Disturbances from the skin and subcutaneous tissues:
often: urticaria and other forms of skin rash;
rarely: photosensitization;
very rarely: necrotizing vasculitis and toxic epidermal necrolysis, lupus-like reactions, exacerbation of cutaneous manifestations of SLE;
frequency unknown: erythema multiforme.
Disturbances from the musculoskeletal and connective tissue:
frequency unknown: muscle spasms.
Violations of the genitals and breast:
often: impotence.
General disorders and disorders at the site of administration:
frequency unknown: hyperthermia, asthenia.