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 side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%,but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - 0.01%, including individual reports.
Enalapril
From the side of the blood and lymphatic system: rarely - reduction of hemoglobin, decrease in hematocrit; very rarely - oppression of bone marrow function, anemia, thrombocytopenia, leukopenia, neutropenia and agranulocytosis, hemolytic anemia, lymphadenopathy, eosinophilia.
From the endocrine system: rarely - the syndrome of inadequate secretion of antidiuretic hormone.
From the nervous system: often - headache, dizziness, fainting; infrequently - insomnia, anxiety, panic, confusion, depression, sleep disturbance, "nightmarish" dreams, drowsiness; rarely - memory impairment, paresthesia, peripheral neuropathy, tremor, migraine, confusion.
From the side of the organ of vision: rarely - visual impairment, conjunctivitis, decreased visual acuity, dryness and burning eyes.
From the side of the hearing organ and labyrinthine disorders: infrequently - vertigo, noise in the ears.
From the cardiovascular system: often - marked decrease in blood pressure, orthostatic hypotension; infrequently - pain in the chest, stenocardia,atrioventricular blockade of II degree, cerebral blood flow disorder, myocardial infarction, palpitation, arrhythmia (atrial fibrillation, sinus bradycardia, tachycardia, ventricular fibrillation).
On the part of the respiratory system, the organs of the thorax and the mediastinum: often - cough; infrequently - a rhinitis, zalozhennost a nose; 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; very rarely - pancreatitis, intestinal obstruction.
From the liver and bile ducts: infrequently - increased activity of "liver" transaminases, increased bilirubin concentration; very rarely - a violation of the liver, hepatitis hepatocellular or cholestatic, jaundice.
From the skin and subcutaneous tissues: rarely - alopecia, psoriasis, dermatitis, dry skin; very rarely - pseudolymphoma, pemphigus.
Allergic reactions: infrequently - a skin rash,itching; rarely - angioedema, swelling of the face, extremities, lips, tongue, vocal cords and / or larynx, dysphonia, urticaria; very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, photosensitivity, intestinal edema.
From the side of the musculoskeletal and connective tissue: often - muscle spasm, pain
in the back, leg pain, myalgia; infrequently - pain in the hands, arthralgia, musculoskeletal pain,
stiffness and swelling of the joints.
From the urinary system: often - renal dysfunction; rarely - uremia, acute renal failure (ARF); very rarely - oliguria, anuria.
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, hyperkalemia; rarely - hyponatremia; very rarely - hyperglycemia, epistaxis, vasculitis, the phenomenon of Raynaud, "tides" of blood to the skin of the face; individual reports describe a symptom complex that may include fever, myalgia and arthralgia, serositis,vasculitis, an increase in the rate of erythrocyte sedimentation, leukocytosis and eosinophilia, a skin rash, a positive test for antinuclear antibodies.
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, increased cholesterol and triglycerides, 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.
From the respiratory system, chest and mediastinum: infrequently - respiratory distress syndrome, pneumonitis, 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).
Allergic reactions: rarely - photosensitivity; very rarely - hives, toxic epidermal necrolysis, Lyell's syndrome.
From the side of the musculoskeletal and connective tissue: infrequently - muscular spasm.
From the urinary system: infrequently - glucosuria, interstitial nephritis, renal failure.
Other: infrequently - fever, hyperkalemia, vasculitis.