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Aricept ODT Side Effects

Generic name: donepezil

Medically reviewed by Drugs.com. Last updated on Jun 5, 2023.

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:

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

Less common

Rare

Incidence not known

Symptoms of overdose

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]

References

1. Product Information. Aricept (donepezil). Pfizer U.S. Pharmaceuticals. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. 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. 1996;7:293-303.

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

6. 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. 1993;31:223-9.

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

8. Babic T, Zurak N. Convulsions induced by donepezil. J Neurol Neurosurg Psychiat. 1999;66:410.

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

10. 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. 2001;62:573-4.

11. Kawashima T, Yamada S. Delirium caused by donepezil: a case study. J Clin Psychiatry. 2002;63:250-1.

12. Onofrj M, Thomas A. Severe worsening of parkinsonism in Lewy body dementia due to donepezil. Neurology. 2003;61:1452.

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

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

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

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

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.