Donepezil is a cholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. It is available as tablets and orally disintegrating tablets. MedsAcross supplies Donepezil for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. ARICEPT is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type.
Source: US FDA prescribing information
Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer’s disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil alters the course of the underlying dementing process.
Source: US FDA prescribing information
Mild to Moderate Alzheimer’s Disease: 5 mg to 10 mg once daily. Moderate to Severe Alzheimer’s Disease: 10 mg to 23 mg once daily Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of ARICEPT is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of ARICEPT in patients with mild to moderate Alzheimer’s disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. Dosing in Moderate to Severe Alzheimer’s Disease The recommended starting dosage of ARICEPT is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of ARICEPT in patients with moderate to severe Alzheimer’s disease is 23 mg per day.
Source: US FDA prescribing information
ARICEPT is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives
Source: US FDA prescribing information
Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block. ARICEPT can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases. Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers. The use of ARICEPT in a dose of 23 mg once daily is associated with weight loss. Cholinomimetics may cause bladder outflow obstructions. Cholinomimetics are believed to have some potential to cause generalized convulsions. Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease
Source: US FDA prescribing information
The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions Nausea and Vomiting Peptic Ulcer Disease and GI Bleeding Weight Loss Genitourinary Conditions Neurological Conditions: Seizures Pulmonary Conditions Most common adverse reactions in clinical studies of ARICEPT are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia
Source: US FDA prescribing information
Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists
Source: US FDA prescribing information
Storage Store at controlled room temperature, 15ºC to 30ºC (59ºF to 86ºF).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
8 presentations of Donepezil, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Donepezil 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Donepezil 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Donepezil 23 mg tabletOralGeneric name | — | US FDA | Available on request |
| Donepezil 10 mg orally disintegrating tabletOralGeneric name | — | US FDA | Available on request |
| Donepezil 5 mg orally disintegrating tabletOralGeneric name | — | US FDA | Available on request |
| Aricept 10 mg tabletOral | Eisai | US FDA | Available on request |
| Aricept 23 mg tabletOral | Eisai | US FDA | Available on request |
| Aricept 5 mg tabletOral | Eisai | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 November 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Donepezil in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 8 presentations of Donepezil and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Donepezil, including Aricept.
Yes. The US FDA first approved Donepezil on 25 November 1996, according to Drugs@FDA.
No listed presentation of Donepezil is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Donepezil is classified under ATC code N06DA02 (Donepezil).
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