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

Applies to donepezil: oral tablet, oral tablet disintegrating. Other dosage forms:

• transdermal patch extended release

Serious side effects of Aricept ODT

Along with its needed effects, donepezil (the active ingredient contained in Aricept ODT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking donepezil:

More common

• Diarrhea
• loss of appetite
• muscle cramps
• nausea
• trouble in sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Abnormal dreams
• constipation
• dizziness
• drowsiness
• fainting
• frequent urination
• headache
• joint pain, stiffness, or swelling
• mental depression
• pain
• unusual bleeding or bruising
• weight loss

Rare

• Black, tarry stools
• bloating
• bloody or cloudy urine
• blurred vision
• burning, prickling, or tingling sensations
• cataract
• chills
• clumsiness or unsteadiness
• confusion
• cough
• decreased urination
• difficult or painful urination
• dryness of mouth
• eye irritation
• fever
• flushing of skin
• frequent urge to urinate
• high or low blood pressure
• hives
• hot flashes
• increase in sexual desire or performance
• increased heart rate and breathing
• increased sweating
• increased urge to urinate during the night
• irregular heartbeat
• itching
• loss of bladder control
• loss of bowel control
• mood or mental changes, including abnormal crying, aggression, agitation, delusions, irritability, nervousness, or restlessness
• nasal congestion
• pain in chest, upper stomach, or throat
• problems with speech
• runny nose
• severe thirst
• shortness of breath
• sneezing
• sore throat
• sunken eyes
• tightness in chest
• tremor
• troubled breathing
• wheezing
• wrinkled skin

Incidence not known

• Back, leg, or stomach pains
• bleeding gums
• chest pain or discomfort
• coma
• convulsions
• dark urine
• difficulty breathing
• fast or irregular heartbeat
• fatigue
• general body swelling
• general tiredness and weakness
• high fever
• increased thirst
• indigestion
• light-colored stools
• muscle pain or cramps
• nausea and vomiting
• nosebleeds
• pains in stomach, side, or abdomen, possibly radiating to the back
• pale skin
• rash
• seeing, hearing, or feeling things that are not there
• seizures
• severe muscle stiffness
• severe nausea
• slow or irregular heartbeat
• stomach pain
• sweating
• swelling of face, ankles, or hands
• tiredness
• unusually pale skin
• upper right abdominal or stomach pain
• yellow eyes and skin

Symptoms of overdose

• Convulsions (seizures)
• increased sweating
• increased watering of mouth
• increasing muscle weakness
• low blood pressure
• severe nausea
• severe vomiting
• slow heartbeat
• troubled breathing

For Healthcare Professionals

Applies to donepezil: oral tablet, oral tablet disintegrating, transdermal film.

General

Frequency of common adverse effects may be influenced by the rate of titration.^[Ref]

The most common adverse events were diarrhea, muscle cramps, fatigue, nausea, vomiting, anorexia and insomnia. Most adverse events are mild in severity and transient in nature.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea, nausea

Common (1% to 10%): Vomiting, abdominal disturbance, tooth ache, fecal incontinence, gastrointestinal bleeding, bloating, epigastric pain

Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, gastric and duodenal ulcers, eructation, gingivitis, flatulence, periodontal abscess, cholelithiasis, 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, hernia hiatal^[Ref]

Nervous system

Very common (10% or more): Headache

Common (1% to 10%): Dizziness, insomnia, somnolence, tremor, paresthesia, ataxia, nervousness, aphasia

Uncommon (0.1% to 1%): Seizure, bad taste, cerebrovascular accident, intracranial hemorrhage, transient ischemic attack, neuralgia, muscle spasm, dysphoria, gait abnormality, hypertonia, hypokinesia, neurodermatitis, numbness (localized), dysarthria, dysphasia, nystagmus, pacing

Rare (less than 0.1%): Extrapyramidal symptoms

Very rare (less than 0.01%): Neuroleptic malignant syndrome^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hemorrhage, syncope, vasodilation, atrial fibrillation, hot flashes, hypotension

Uncommon (0.1% to 1%): Bradycardia, angina pectoris, postural hypotension, myocardial infarction, AV block (first degree), congestive heart failure, arteritis, peripheral vascular disease, supraventricular tachycardia, deep vein thrombosis.

Rare (less than 0.1%): SA block, AV block^[Ref]

Dermatologic

Common (1% to 10%): Eczema rash, pruritus, ecchymosis, diaphoresis, urticaria

Uncommon (0.1% to 1%): Dermatitis, erythema, skin discoloration, hyperkeratosis, alopecia, fungal dermatitis, hirsutism, skin striae, night sweats, skin ulcer^[Ref]

Genitourinary

Common (1% to 10%): Urinary incontinence, nocturia

Uncommon (0.1% to 1%): Dysuria, hematuria, urinary urgency, metrorrhagia, cystitis, enuresis, prostate hypertrophy, pyelonephritis, inability to empty bladder, breast fibroadenosis, fibrocystic breast, mastitis, pyuria, renal failure, vaginitis^[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased weight, dehydration

Uncommon (0.1% to 1%): Increased appetite, gout, hypokalemia, hyperglycemia, increased lactate dehydrogenase^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps, arthritis, bone fracture

Uncommon (0.1% to 1%): Muscle weakness, muscle fasciculation^[Ref]

Ocular

Common (1% to 10%): Cataract, eye irritation, vision blurred

Uncommon (0.1% to 1%): Dry eyes, glaucoma, blepharitis, retinal hemorrhage, conjunctival hemorrhage, spots before eyes, periorbital edema^[Ref]

Other

Common (1% to 10%): Fatigue, pain, accidental overdose, vertigo, abnormal crying

Uncommon (0.1% to 1%): Minor increase in serum concentration of muscle creatine kinase, diverticulitis, earache, tinnitus, decreased hearing, otitis externa, otitis media, ear buzzing, motion sickness, herpes zoster, coldness (localized), fever, edema face, abscess, cellulitis, chills, generalized coldness, head fullness^[Ref]

Psychiatric

Common (1% to 10%): Hallucinations, agitation, aggressive behavior, abnormal dreams, nightmares, delusions, irritability, aggression, increased libido, restlessness

Uncommon (0.1% to 1%): Emotional lability, paranoia, hostility, decreased libido, melancholia, emotional withdrawal, listlessness^[Ref]

Respiratory

Common (1% to 10%): Common cold, influenza, chest pain, dyspnea, sore throat, bronchitis

Uncommon (0.1% to 1%): Epistaxis, post nasal drip, pneumonia, hyperventilation, pulmonary congestion, wheezing, hypoxia, pharyngitis, pleurisy, pulmonary collapse, sleep apnea, snoring^[Ref]

Endocrine

Uncommon (0.1% to 1%): Diabetes mellitus, goiter^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, thrombocythemia, thrombocytopenia, eosinophilia, erythrocytopenia^[Ref]

Hepatic

Rare (less than 0.1%): Liver dysfunction (including hepatitis)^[Ref]