Donepezil side effects

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

List of side effects[edit | edit source]

Mild to moderate Alzheimer's disease

Adverse events leading to discontinuation (moderate Alzheimer's disease)
- Effect of rate of titration
Adverse events reported in controlled trials (moderate Alzheimer's disease)
Other adverse events observed during clinical trials (moderate Alzheimer's disease)

Severe Alzheimer's disease

Adverse events leading to discontinuation (severe Alzheimer's disease)
Most frequent adverse clinical events seen in association with the use of Aricept® (severe Alzheimer's disease)
Other adverse events observed during clinical trials (severe Alzheimer's disease)

Postintroduction reports

Mild to moderate Alzheimer's disease[edit | edit source]

Adverse events leading to discontinuation (moderate Alzheimer's disease)[edit | edit source]

The rates of discontinuation from controlled clinical trials of Aricept® due to adverse events for the Aricept® 5 mg/day treatment groups were comparable to those of placebo-treatment groups at approximately 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day, was higher at 13%. Return to top

Most frequent adverse clinical events seen in association with the use of Aricept® (moderate Alzheimer's disease)[edit | edit source]

The most common adverse events, defined as those occurring at a in patifrequency of at least 5%ents receiving 10 mg/day and twice the placebo rate, are largely predicted by Aricept®'s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. These adverse events were often of mild intensity and trancontinuesient, resolving during d Aricept® treatment without the need for dose modification. Return to top

Effect of rate of titration[edit | edit source]

There is evidence to suggest that the frequency of these common adverse events may be affected by the rate of titration. An open-label study was conducted with 269 patients who received placebo in the 15 and 30-week studies. These patients were titrated to a dose of 10 mg/day over a 6-week period. The rates of common adverse events were lower than those seen in patients titrated to 10 mg/day over one week in the controlled clinical trials and were comparable to those seen in patients on 5 mg/day. Return to top

Adverse events reported in controlled trials (moderate Alzheimer's disease)[edit | edit source]

The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. In general, adverse events occurred more frequently in female patients and with advancing age. Return to top

Other adverse events observed during clinical trials (moderate Alzheimer's disease)[edit | edit source]

Body as a whole (moderate Alzheimer's disease)[edit | edit source]

Frequent: influenza, chest pain, toothache;
Infrequent: fever, edema face, periorbital edema, hernia hiatal, abscess, cellulitis, chills, generalized coldness, head fullness, listlessness. Return to top

Cardiovascular system (moderate Alzheimer's disease)[edit | edit source]

Frequent: hypertension, vasodilation, atrial fibrillation, hot flashes, hypotension;
Infrequent: angina pectoris, postural hypotension, myocardial infarction, AV block (first degree), congestive heart failure, arteritis, bradycardia, peripheral vascular disease, supraventricular tachycardia, deep vein thrombosis. Return to top

Digestive system (moderate Alzheimer's disease)[edit | edit source]

Frequent: fecal incontinence, gastrointestinal bleeding, bloating, epigastric pain;
Infrequent: eructation, gingivitis, increased appetite, flatulence, periodontal abscess, cholelithiasis, diverticulitis, drooling, dry mouth, fever sore, gastritis, irritable colon, tongue edema, epigastric distress, gastroenteritis, increased transaminases, hemorrhoids, ileus, increased thirst, jaundice, melena, polydipsia, duodenal ulcer, stomach ulcer. Return to top

Endocrine system (moderate Alzheimer's disease)[edit | edit source]

Infrequent: diabetes mellitus, goiter. Return to top

Hemic and lymphatic system (moderate Alzheimer's disease)[edit | edit source]

Infrequent: anemia, thrombocythemia, thrombocytopenia, eosinophilia, erythrocytopenia. Return to top

Metabolic and nutritional disorders (moderate Alzheimer's disease)[edit | edit source]

Frequent: dehydration;
Infrequent: gout, hypokalemia, increased creatine kinase, hyperglycemia, weight increase, increased lactate dehydrogenase. Return to top

Musculoskeletal system (moderate Alzheimer's disease)[edit | edit source]

Frequent: bone fracture;
Infrequent: muscle weakness, muscle fasciculation. Return to top

Nervous system (moderate Alzheimer's disease)[edit | edit source]

Frequent: delusions, tremor, irritability, paresthesia, aggression, vertigo, ataxia, increased libido, restlessness, abnormal crying, nervousness, aphasia;
Infrequent: cerebrovascular accident, intracranial hemorrhage, transient ischemic attack, emotional lability, neuralgia, coldness (localized), muscle spasm, dysphoria, gait abnormality, hypertonia, hypokinesia, neurodermatitis, numbness (localized), paranoia, dysarthria, dysphasia, hostility, decreased libido, melancholia, emotional withdrawal, nystagmus, pacing. Return to top

Respiratory system (moderate Alzheimer's disease)[edit | edit source]

Frequent: dyspnea, sore throat, bronchitis;
Infrequent: epistaxis, post nasal drip, pneumonia, hyperventilation, pulmonary congestion, wheezing, hypoxia, pharyngitis, pleurisy, pulmonary collapse, sleep apnea, snoring. Return to top

Skin and appendages (moderate Alzheimer's disease)[edit | edit source]

Frequent: pruritus, diaphoresis, urticaria;
Infrequent: dermatitis, erythema, skin discoloration, hyperkeratosis, alopecia, fungal dermatitis, herpes zoster, hirsutism, skin striae, night sweats, skin ulcer. Return to top

Special senses (moderate Alzheimer's disease)[edit | edit source]

Frequent: cataract, eye irritation, vision blurred;
Infrequent: dry eyes, glaucoma, earache, tinnitus, blepharitis, decreased hearing, retinal hemorrhage, otitis externa, otitis media, bad taste, conjunctival hemorrhage, ear buzzing, motion sickness, spots before eyes. Return to top

Urogenital system (moderate Alzheimer's disease)[edit | edit source]

Frequent: urinary incontinence, nocturia;
Infrequent: dysuria, hematuria, urinary urgency, metrorrhagia, cystitis, enuresis, prostate hypertrophy, pyelonephritis, inability to empty bladder, breast fibroadenosis, fibrocystic breast, mastitis, pyuria, renal failure, vaginitis. Return to top

Severe Alzheimer's disease[edit | edit source]

Adverse events leading to discontinuation (severe Alzheimer's disease)[edit | edit source]

The rates of discontinuation from controlled clinical trials of Aricept® due to adverse events for the Aricept® patients were approximately 12% compared to 7% for placebo patients.
The most common adverse events leading to discontinuation, defined as those occurring in at least 2% of Aricept® patients and at twice the incidence seen in placebo patients, were anorexia (2% vs 1% placebo), nausea (2% vs <1% placebo), diarrhea (2% vs 0% placebo) and urinary tract infection (2% vs 1% placebo). Return to top

Most frequent adverse clinical events seen in association with the use of Aricept® (severe Alzheimer's disease)[edit | edit source]

The most common adverse events, defined as those occurring at a frequency of at least 5% in patients receiving Aricept® and twice the placebo rate, are largely predicted by Aricept®'s cholinomimetic effects. These include diarrhea, anorexia, vomiting, nausea, and ecchymosis. These adverse events were often of mild intensity and transient, resolving during continued Aricept® treatment without the need for dose modification. Return to top

Other adverse events observed during clinical trials (severe Alzheimer's disease)[edit | edit source]

These adverse events are not necessarily related to Aricept® treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies.

Body as a whole (severe Alzheimer's disease)[edit | edit source]

Frequent: abdominal pain, asthenia, fungal infection, flu syndrome;
Infrequent: allergic reaction, cellulitis, malaise, sepsis, face edema, hernia. Return to top

Cardiovascular system (severe Alzheimer's disease)[edit | edit source]

Frequent: hypotension, bradycardia, ECG abnormal, heart failure;
Infrequent: myocardial infarction, angina pectoris, atrial fibrillation, congestive heart failure, peripheral vascular disorder, supraventricular extrasystoles, ventricular extrasystoles, cardiomegaly. Return to top

Digestive system (severe Alzheimer's disease)[edit | edit source]

Frequent: constipation, gastroenteritis, fecal incontinence, dyspepsia;
Infrequent: gamma glutamyl transpeptidase increase, gastritis, dysphagia, periodontitis, stomach ulcer, periodontal abscess, flatulence, liver function tests abnormal, eructation, esophagitis, rectal hemorrhage. Return to top

Endocrine system (severe Alzheimer's disease)[edit | edit source]

Infrequent: diabetes mellitus. Return to top

Hemic and lymphatic system (severe Alzheimer's disease)[edit | edit source]

Frequent: anemia;
Infrequent: leukocytosis. Return to top

Metabolic and nutritional disorders (severe Alzheimer's disease)[edit | edit source]

Frequent: weight loss, peripheral edema, edema, lactic dehydrogenase increased, alkaline phosphatase increased;
Infrequent: hypercholesteremia, hypokalemia, hypoglycemia, weight gain, bilirubinemia, BUN increased, B12 deficiency anemia, cachexia, creatinine increased, gout, hyponatremia, hypoproteinemia, iron deficiency anemia, SGOT increased, SGPT increased. Return to top

Musculoskeletal system (severe Alzheimer's disease)[edit | edit source]

Frequent: arthritis;
Infrequent: arthrosis, bone fracture, arthralgia, leg cramps, osteoporosis, myalgia. Return to top

Nervous system (severe Alzheimer's disease)[edit | edit source]

Frequent: agitation, anxiety, tremor, convulsion, wandering, abnormal gait;
Infrequent: apathy, vertigo, delusions, abnormal dreams, cerebrovascular accident, increased salivation, ataxia, euphoria, vasodilatation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal syndrome, grand mal convulsion, hemiplegia, hypertonia, hypokinesia. Return to top

Respiratory system (severe Alzheimer's disease)[edit | edit source]

Frequent: pharyngitis, pneumonia, cough increased, bronchitis;
Infrequent: dyspnea, rhinitis, asthma. Return to top

Skin and appendages (severe Alzheimer's disease)[edit | edit source]

Frequent: rash, skin ulcer, pruritus;
Infrequent: psoriasis, skin discoloration, herpes zoster, dry skin, sweating, urticaria, vesiculobullous rash Return to top

Special senses (severe Alzheimer's disease)[edit | edit source]

Infrequent: conjunctivitis, glaucoma, abnormal vision, ear pain, lacrimation disorder. Return to top

Urogenital system (severe Alzheimer's disease)[edit | edit source]

Frequent: urinary tract infection, cystitis, hematuria, glycosuria;
Infrequent: vaginitis, dysuria, urinary frequency, albuminuria. Return to top

Postintroduction reports[edit | edit source]

Voluntary reports of adverse events temporally associated with Aricept® that have been received since market introduction that are not listed above, and that there is inadequate data to determine the causal relationship with the drug include the following: abdominal pain, agitation, cholecystitis, confusion, convulsions, hallucinations, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, and rash. Return to top

Adapted from the FDA Package Insert.