In clinical studies of the enalapril / hydrochlorothiazide combination, no adverse events specific to this combination drug were observed. Undesirable effects were limited to those reported earlier with enalapril and / or hydrochlorothiazide alone.
The incidence of adverse events is classified according to the recommendations of the World Health Organization (WHO):
very often (> 1/10)
often (> 1/100 and <1/10)
infrequently (> 1/1000 and <1/100)
rarely (> 1/10000 and <1/1000)
very rarely (<1/10000), including individual messages.
Enalapril
From the hemopoietic system and lymphatic system:
rarely: a decrease in hemoglobin and hematocrit;
very rarely - oppression of bone marrow function, anemia, thrombocytopenia, leukopenia, neutropenia and agranulocytosis, hemolytic anemia, lymphadenopathy, eosinophilia, autoimmune diseases;
From the endocrine system:
rarely: syndrome of inadequate secretion of antidiuretic hormone.
From the neutral nervous system:
often: headache, dizziness, fainting;
infrequently: insomnia, anxiety, panic, confusion, depression, sleep disturbance, "nightmarish" dreams, drowsiness;
rarely: paresthesia, memory impairment, peripheral neuropathy, tremor, migraine, confusion;
From the side of the organ of vision:
rarely: blurred vision, conjunctivitis, decreased visual acuity, dryness and burning eyes;
From the organ of hearing:
infrequently: vertigo, noise in the ears;
From the cardiovascular system:
often: marked decrease in blood pressure, orthostatic hypotension;
infrequent: palpitation, chest pain, arrhythmias (atrial fibrillation, sinus bradycardia, tachycardia, ventricular fibrillation), stenocardia, atrioventricular blockade of degree II, cerebral circulation disorder, myocardial infarction;
From the respiratory system:
often: cough;
infrequently: rhinitis, nasal congestion;
very rarely: sinusitis, pharyngitis, laryngitis, sore throat, hoarseness, dyspnea, bronchitis, lung infiltrates, bronchospasm / bronchial asthma;
From the digestive system:
often: nausea, diarrhea; infrequently: abdominal pain, constipation;
rarely: dryness of the oral mucosa, stomatitis, flatulence, vomiting, gastritis, taste disorder, peptic ulcer, aphthous ulcers;
very rarely: pancreatitis, intestinal obstruction, intestinal angioedema;
From the liver and bile ducts:
infrequently: increased activity of "hepatic" transaminases, increased bilirubin concentration;
very rarely: a violation of the liver, hepatitis, hepatocellular or cholestatic, jaundice;
Allergic reactions:
infrequent: skin rash, itching;
rarely: angioedema, swelling of the face, limbs, lips, tongue, vocal cords and / or larynx, dysphonia, urticaria;
very rarely: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, photosensitivity;
From the skin:
rarely: alopecia, psoriasis, dermatitis, dry skin;
very rarely: pseudolymphoma, pemphigus;
From the genitourinary system:
often: impaired renal function;
rarely: uremia, acute renal failure, proteinuria;
very rarely: oliguria, anuria;
From the musculoskeletal system:
often: muscle spasms, back pain, leg pain, myalgia;
infrequently: pain in hands, arthralgia, musculoskeletal pain, stiffness and swelling of the joints;
On the part of the reproductive system:
infrequently: impotence;
rarely: gynecomastia;
Other:
often: asthenia, fatigue, hyperkalemia;
infrequent: increased body temperature, a slight increase in the concentration of urea and creatinine;
rarely: hyponatremia;
very rarely: hyperglycemia, in patients with diabetes - hypoglycemia, epistaxis, vasculitis, Raynaud's syndrome, "tides" of blood to the skin of the face.
describes a symptom complex that may include fever, myalgia and arthralgia, serositis, vasculitis, increased erythrocyte sedimentation rate, leukocytosis and eosinophilia, skin rash, positive antinuclear antibody test.
Hydrochlorothiazide
From the side of the blood and lymphatic system:
rarely: neutropenia and agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, leukopenia, oppression of bone marrow function.
From the side of metabolism and nutrition:
infrequently: anorexia, hyperglycemia, hyperuricemia, hypokalemia, hyponatremia, hypomagnesemia,hypercalcemia and hypochloraemic alkalosis, increased concentrations of cholesterol and triglycerides, exacerbation of gout;
From the nervous system:
often: depression, sleep disturbance;
infrequently: insomnia, paresthesia, dizziness;
From the side of the organ of vision:
rarely: transient visual impairment, xantopsy;
From the organ of hearing:
rarely: vertigo;
From the cardiovascular system:
rarely: orthostatic hypotension, vasculitis, arrhythmia;
From the respiratory system:
infrequently: respiratory distress syndrome (including pneumonitis and non-cardiogenic pulmonary edema);
From the digestive system:
rarely: sialadenitis, constipation, diarrhea, irritation of the gastrointestinal mucosa;
very rarely: pancreatitis;
From the liver and bile ducts:
infrequently: jaundice (intrahepatic cholestasis), cholecystitis;
Allergic reactions:
rarely: photosensitization;
very rarely: urticaria, toxic epidermal necrolysis, Lyell's syndrome, purpura, necrotizing vasculitis, Stevens-Johnson syndrome, anaphylactic reactions up to shock;
Other: decreased potency, fever.