Applies to donepezil: oral tablet, oral tablet disintegrating
The case of restless legs, mumbling, and stuttering resolved after discontinuation of donepezil (the active ingredient contained in Aricept) and there was a positive rechallenge.
Nervous system side effects have included headache (10%), insomnia (up to 9%), dizziness (up to 8%), hostility (3%), nervousness (3%), hallucinations (3%), somnolence (2%), depression (2%), confusion (2%), emotional lability (2%), and personality disorder (2%). Delusions, tremor, irritability, paresthesia, aggression, vertigo, ataxia, increased libido, restlessness, abnormal crying, and aphasia have been reported frequently. Cerebrovascular accident, intracranial hemorrhage, transient ischemic attack, neuralgia, coldness (localized), muscle spasm, dysphoria, gait abnormality, hypertonia, hypokinesia, neurodermatitis, numbness (localized), paranoia, dysarthria, dysphasia, decreased libido, melancholia, emotional withdrawal, nystagmus, and pacing have been reported infrequently. A case of Pisa Syndrome and a dose-related case of restless legs, mumbling, and stuttering have been reported. Two cases of worsening Parkinson's disease, a case report of convulsions, and a case report of delirium which may possibly have been associated with the use of donepezil have also been reported.
Genitourinary side effects including incontinence (7%) have been reported. Nocturia has been reported frequently. Dysuria, hematuria, urinary urgency, metrorrhagia, cystitis, enuresis, prostate hypertrophy, pyelonephritis, inability to empty bladder, breast fibroadenosis, fibrocystic breast, mastitis, pyuria, renal failure, and vaginitis have been reported infrequently.
Musculoskeletal side effects including muscle cramps (6%) and back pain (3%) have been reported. Bone fracture has been reported frequently. Muscle weakness, and muscle fasciculation have been reported infrequently.
Gastrointestinal side effects reported in at least 5% of patients include nausea, vomiting, diarrhea, and anorexia. Fecal incontinence, gastrointestinal bleeding, bloating, and epigastric pain have been reported frequently. 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, and stomach ulcer have been reported infrequently.
Dermatologic side effects including eczema (3%) have been reported. Pruritus, diaphoresis, and urticaria have been reported frequently. Dermatitis, erythema, skin discoloration, hyperkeratosis, alopecia, fungal dermatitis, herpes zoster, hirsutism, skin striae, night sweats, and skin ulcer have been reported infrequently. A case of purpuric rash has been reported.
Cardiovascular side effects including hypertension (up to 3%), hemorrhage (up to 2%), and syncope (2%) have been reported. Hypotension and bradycardia have been reported in less than 1% of patients. Vasodilation, atrial fibrillation, hot flashes, and hypotension have been reported frequently. Angina pectoris, postural hypotension, myocardial infarction, AV block (first degree), congestive heart failure, arteritis, bradycardia, peripheral vascular disease, supraventricular tachycardia, and deep vein thrombosis have been reported infrequently.
Metabolic side effects have included dehydration (2%), hyperlipemia (2%), and weight loss with increasing dosage. Gout, hypokalemia, increased creatine kinase, hyperglycemia, increased weight, and increased lactate dehydrogenase have been reported infrequently.
Frequency of common adverse effects may be influenced by the rate of titration.
General side effects including fever (2%) and chest pain (2%) have been reported. Fever, facial edema, periorbital edema, hiatal hernia, abscess, cellulitis, chills, generalized coldness, head fullness, and listlessness have been reported infrequently. Side effects are generally mild in nature and well tolerated.
Other side effects including earache, tinnitus, decreased hearing, otitis externa, otitis media, bad taste, ear buzzing, and motion sickness have been reported infrequently. Cholinergic effects such as frequent urination have been reported in 2% of patients. Tremor, restlessness, hypertension, hypotension, ataxia, bradycardia, and diaphoresis have been reported in less than 1% of patients.
Ocular side effects including cataract, eye irritation, and blurred vision have been reported frequently. Dry eyes, glaucoma, blepharitis, retinal hemorrhage, conjunctival hemorrhage, and spots before eyes have been reported infrequently.
Endocrine side effects including diabetes mellitus and goiter have been reported infrequently.
Hematologic side effects including anemia, thrombocythemia, thrombocytopenia, eosinophilia, and erythrocytopenia have been reported infrequently.
Respiratory side effects including dyspnea, sore throat, and bronchitis have been reported frequently. Epistaxis, post nasal drip, pneumonia, hyperventilation, pulmonary congestion, wheezing, hypoxia, pharyngitis, pleurisy, pulmonary collapse, sleep apnea, and snoring have been reported infrequently.
Psychiatric side effects including nightmares have been reported.