Aricept Side Effects

Generic name: donepezil

Note: This document contains side effect information about donepezil. Some of the dosage forms listed on this page may not apply to the brand name Aricept.

Some side effects of Aricept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to donepezil: oral tablet, oral tablet disintegrating

Get emergency medical help if you have any of these signs of an allergic reaction while taking donepezil (the active ingredient contained in Aricept) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using donepezil and call your doctor at once if you have any of these serious side effects:

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like blood or coffee grounds;

• painful or difficult urination;

• seizure (black-out or convulsions);

Less serious side effects of donepezil may include:

• nausea, vomiting, diarrhea;

• loss of appetite;

• muscle cramps;

• tired feeling; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to donepezil: oral tablet, oral tablet disintegrating

Nervous system

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

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

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

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

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

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

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.

General

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

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

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

Endocrine side effects including diabetes mellitus and goiter have been reported infrequently.

Hematologic

Hematologic side effects including anemia, thrombocythemia, thrombocytopenia, eosinophilia, and erythrocytopenia have been reported infrequently.

Respiratory

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

Psychiatric side effects including nightmares have been reported.

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