Alzheimer's disease of mild to moderate severity:
More frequente (frequency ≥5% and twice as high as in the placebo group) - diarrhea, nausea, vomiting, muscle cramps, fatigue, insomnia.
Frequent (frequency ≥ 5% and ≥ than in the placebo group) - headache, pain of different locations, accidents, colds, gastrointestinal disorders and dizziness.
Rarely - fainting, bradycardia, sinoatrial and atrioventricular block. Laboratory indicators - a slight increase in the activity of the muscle isoform of creatine phosphokinase in the serum; There were no other significant deviations of laboratory parameters from the norm.
Frequent - phenomena that developed in at least 1/100 patients;
Infrequent - phenomena that developed in 1/100 - 1/1000 patients.
These side effects were not necessarily associated with treatment with Aricept®, and in most cases in controlled studies their frequency was similar to that in the placebo group.
Organism as a whole:
Frequent: flu, pain in the chest, toothache;
infrequent: fever, edema of the face, periorbital edema, hernia of the esophageal opening of the diaphragm, abscess, phlegmon, chills, general chills, sensation of head overflow, apathy.
From the side of the cardiovascular system:
Frequent: increased blood pressure, vasodilatation, atrial fibrillation, hot flushes, lowering blood pressure;
infrequent: stenocardia, postural hypotension, myocardial infarction, AV blockade (first degree), chronic heart failure, arteritis, bradycardia, peripheral vascular disease, supraventricular tachycardia, deep vein thrombosis.
From the digestive system:
Frequent: fecal incontinence, gastrointestinal bleeding, bloating, epigastric pain;
infrequent: eructation, gingivitis, increased appetite, flatulence, periodontal abscess, cholelithiasis, diverticulitis, salivation, dry mouth, herpes simplex, gastritis, irritable bowel syndrome, tongue edema, gastric discomfort, gastroenteritis, increased transaminase activity, hemorrhoids, intestinal obstruction, strong thirst, jaundice, melena, polydipsia, duodenal ulcer, stomach ulcer.
From the endocrine system:
infrequent: diabetes mellitus, goitre.
On the part of the blood and lymphatic system:
infrequent: anemia, thrombocytosis, thrombocytopenia, eosinophilia, erythropenia.
From the side of metabolism and nutrition:
Frequent: dehydration;
infrequent: gout, hypokalemia, increased activity of creatine phosphokinase, hyperglycemia, weight gain, increased lactate dehydrogenase activity.
From the musculoskeletal system:
Frequent: bone fracture;
infrequent: muscle weakness, myofascing.
From the nervous system:
Frequent: delirium, tremor, irritability, paresthesia, aggression, vertigo, ataxia, increased libido, anxiety, pathological cry, increased excitability, aphasia;
infrequent: stroke, intracranial hemorrhage, transient ischemic attack, emotional lability, neuralgia, chills (localized), muscle spasm, dysphoria, abnormal gait, increased muscle tone, hypokinesia, neurodermatitis, numbness (localized), paranoia, dysarthria, dysphasia, hostility, decreased libido , melancholy, emotional fence, nystagmus, gait in large steps.
From the respiratory system:
frequent: shortness of breath, sore throat, bronchitis;
infrequent: vomiting, the flow of mucus from the nasopharynx, pneumonia, hyperventilation, stagnation in the lungs, wheezing, hypoxia, pharyngitis, pleurisy, lung collapse, sleep apnea, snoring.
From the skin and subcutaneous tissues:
Frequent: itching, profuse sweating, urticaria;
infrequent: dermatitis, erythema, skin discoloration, hyperkeratosis, alopecia, fungal dermatitis, shingles, hirsutism, skin striae, night sweats, skin ulcers.
From the sense organs:
Frequent: cataract, eye irritation, blurred vision;
infrequent: dry eyes, glaucoma, earache, ringing in the ears, blepharitis, hearing loss, retinal hemorrhage, otitis externa, otitis media, unpleasant taste in the mouth, conjunctival hemorrhage, tinnitus, kinetosis, flies before the eyes.
From the genitourinary system:
frequent: urinary incontinence; nocturia;
infrequent: dysuria, hematuria, urination, metrorrhagia, cystitis, enuresis, hyperplasia, prostate, pyelonephritis, inability to empty the bladder, fibroadenosis of the mammary glands, fibrocystic mastopathy, mastitis, pyuria, renal failure, vaginitis.
Alzheimer's disease of severe severity:
The most frequent (frequency not less than 5% and 2 times higher than in the placebo group, in most cases effects could be predicted based on the holinomimetic effect of donepezil): diarrhea, anorexia, vomiting, nausea and ecchymosis. These adverse events in most cases were transient, characterized by mild severity, and continued with continued donepezil therapy without the need for a dose change.
Frequent - phenomena that developed in at least 1/100 patients;
Infrequent - phenomena developing in 1 / 100-1 / 1000 patients.
These side effects were not necessarily associated with treatment with Aricept®, and in most cases in controlled studies their frequency was similar to that in the placebo group.
Organism as a whole:
Frequent: abdominal pain, asthenia, fungal infection, influenza-like syndrome;
infrequent: allergic reaction, phlegmon, malaise, sepsis, edema of the face, hernia.
From the side of the cardiovascular system:
frequent: lowering blood pressure, bradycardia, abnormal abnormalities of ECG parameters, heart failure; infrequent: myocardial infarction, angina pectoris, atrial fibrillation, chronic cardiac failure, peripheral vascular disease, supraventricular extrasystoles, ventricular extrasystoles, cardiomegaly.
From the digestive system:
frequent: constipation, gastroenteritis, stool incontinence, indigestion;
infrequent: increased activity of gamma-glutamyltranspeptidase, gastritis, dysphagia, periodontitis, gastric ulcer, periodontal abscess, flatulence, pathological deviation of the results of functional hepatic tests, vomiting, esophagitis, rectal bleeding.
From the endocrine system:
infrequent: diabetes.
On the part of the blood and lymphatic system:
frequent: anemia; infrequent: leukocytosis.
From the side of metabolism and nutrition:
frequent: loss of mass, body, peripheral edema, increased lactate dehydrogenase activity, increased alkaline phosphatase activity;
infrequent: hypercholesterolemia, hypokalemia, hypoglycemia, weight gain, hyperbilirubinemia, increased blood urea nitrogen concentration, B12-deficit anemia, cachexia, increased creatinine concentration, gout, hyponatremia, hypoproteinemia,iron deficiency anemia, increased activity of ALT and AST.
From the musculoskeletal system:
Frequent: arthritis;
infrequent: arthrosis, bone fracture, arthralgia, lower extremity cramps, osteoporosis, myalgia.
From the nervous system:
Frequent: agitation, anxiety, tremor, convulsions, vagrancy, pathological gait;
infrequent: apathy, vertigo, delirium, abnormal dreams, stroke, increased salivation, ataxia, euphoria, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal syndrome, grand mal seizure, hemiplegia, increased muscle tone, hypokinesia.
From the respiratory system:
Frequent: pharyngitis, pneumonia, coughing, bronchitis;
infrequent: shortness of breath, rhinitis, bronchospasm.
From the skin and subcutaneous tissues:
frequent: rash, skin ulcer, itching;
infrequent: psoriasis, skin discoloration, shingles, dry skin, sweating, urticaria, vesicle-bullous rash.
From the sense organs:
infrequent: conjunctivitis, glaucoma, impaired vision, earache, tearing disorder.
From the genitourinary system:
Frequent: infection of the urinary tract, cystitis, hematuria, glucosuria;
infrequent: vaginitis, dysuria, frequent urination, albuminuria.
Side effects recorded in post-marketing research:
Cases of hallucinations, aggressive behavior, seizures, hepatitis, stomach ulcers, duodenal ulcers and gastrointestinal bleeding.