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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.

In Summary

Common side effects of Aricept include: diarrhea, insomnia, and nausea. Other side effects include: fatigue, muscle cramps, vomiting, weight loss, anorexia, and ecchymoses. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to donepezil: oral tablet, oral tablet disintegrating

Along with its needed effects, donepezil (the active ingredient contained in Aricept) 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

Less common

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

General

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]

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

References

1. "Product Information. Aricept (donepezil)." Pfizer US Pharmaceuticals, New York, NY.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Lam W "Pharmacological treatment of cognitive deficits in Alzheimer's disease." Med J Aust 176 (2002): 297; discussion 297-8

5. Rogers SL, Friedhoff LT "The efficacy and safety of donepezil in patients with Alzheimer's disease: results of a US multicentre, randomized, double-blind, placebo-controlled trial." Dementia 7 (1996): 293-303

6. Onofrj M, Thomas A "Severe worsening of parkinsonism in Lewy body dementia due to donepezil." Neurology 61 (2003): 1452

7. Rozzini L, Ghianda D, Trabucchi M, Padovani A "Severe worsening of parkinsonism in Lewy body dementia due to donepezil." Neurology 63 (2004): 1543-4; author reply 1543-4

8. Kawashima T, Yamada S "Delirium caused by donepezil: a case study." J Clin Psychiatry 63 (2002): 250-1

9. Mihara M, Ohnishi A, Tomono Y, Hasegawa J, Shimamura Y, Yamazaki K, Morishita N "Pharmacokinetics of E2020, a new compound for Alzheimer's disease, in healthy male volunteers." Int J Clin Pharmacol Ther Toxicol 31 (1993): 223-9

10. Amouyal-Barkate K, Bagheri-Charabiani H, Montastruc JL, Moulias S, Vellas B "Abnormal movements with doneprzil in Alzheimer disease." Ann Pharmacother 34 (2000): 1347

11. Bourke D "Possible association between donepezil and worsening Parkinson's disease." Ann Pharmacother 32 (1998): 610-11

12. Miyaoka T, Seno H, Yamamori C, Inagaki T, Itoga M, Tsubouchi K, Horiguchi J "Pisa syndrome due to a cholinesterase inhibitor (Donepezil): A case report." J Clin Psychiatry 62 (2001): 573-4

13. Babic T, Zurak N "Convulsions induced by donepezil." J Neurol Neurosurg Psychiat 66 (1999): 410

14. Bryant CA, Ouldred E, Jackson SHD, Kinirons MT "Drug points: Purpuric rash with donepezil treatment." BMJ 317 (1998): 787

15. Hashimoto M, Imamura T, Tanimukai S, Kazui H, Mori E "Urinary incontinence: an unrecognised adverse effect with donepezil." Lancet 356 (2000): 568

16. Iraqi A, Hughes TL "An unusual case of nightmares with galantamine." J Am Geriatr Soc 57 (2009): 565

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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