Donepezil
Donepezil is a prescription medicine used to treat dementia caused by Alzheimer's disease — mild, moderate, and severe stages.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 54 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Donepezil is the usual first-choice medicine for Alzheimer's dementia, from mild through severe stages; it blocks the enzyme that breaks down acetylcholine, a brain messenger, so more of it stays around for memory and thinking, and after decades on the market since the 1990s, it is available as a generic. Most people tolerate it reasonably well, though nausea, diarrhea, trouble sleeping and muscle cramps are common, especially after a dose increase. The one thing to watch for is a slowed heartbeat, even without known heart disease, so call promptly about feeling faint, lightheaded or fainting. It does not cure Alzheimer's, so success often looks like holding steady or slipping more slowly rather than a turnaround.
Clinical pearls
- Avoid regular ibuprofen, naproxen or aspirin unless prescribed, and report black stools or heartburn, since donepezil raises ulcer and bleeding risk.
- Tell the surgeon, anesthesiologist and dentist about donepezil, because it strengthens and prolongs muscle relaxants like succinylcholine.
- Bladder medicines such as oxybutynin and allergy aids like diphenhydramine are anticholinergic and directly work against donepezil.
- Mention any seizure history, asthma, lung disease or prostate trouble, since donepezil can worsen each of these.
Patient information guide A plain-language walkthrough of Donepezil, written from its FDA label.
What Donepezil is used for
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Donepezil is approved to treat dementia caused by Alzheimer's disease.
- Treats mild Alzheimer's disease dementia
- Treats moderate Alzheimer's disease dementia
- Treats severe Alzheimer's disease dementia
- Aricept (tablet) is indicated for mild, moderate, and severe Alzheimer's disease dementia
- Donepezil hydrochloride tablets are indicated for mild, moderate, and severe Alzheimer's disease dementia
- Donepezil Hydrochloride orally disintegrating tablets are indicated for mild, moderate, and severe Alzheimer's disease dementia
How Donepezil works
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Alzheimer's disease is linked to low levels of acetylcholine, a brain chemical that nerve cells use to communicate — especially for memory and thinking. Donepezil is a cholinesterase inhibitor, meaning it blocks the enzyme (acetylcholinesterase) that normally breaks acetylcholine down. By slowing that process, it allows more acetylcholine to remain active in the brain, which can help improve or stabilize cognitive symptoms.
Importantly, donepezil does not change the underlying Alzheimer's disease process — it manages symptoms but does not stop or reverse the condition itself.
Donepezil dosage
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Donepezil is taken once daily by mouth, in the evening just before going to bed. Both the standard tablet and the orally disintegrating tablet (ODT) can be taken with or without food. The ODT is placed on the tongue to dissolve, then followed with a drink of water. Doses are started low and increased gradually over weeks or months under a doctor's supervision — never adjust the dose on your own.
- If you miss a dose, skip it and take your next dose at the usual time — never double up
- If you miss 7 or more days in a row, check with your doctor before restarting
- The higher-strength tablet must be swallowed whole — do not split, crush, or chew it
Dosing details from the FDA-approved label
From the Donepezil prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Mild to Moderate Alzheimer's Disease
- Starting dosage 5 mg administered once per day in the evening, just prior to retiring
- 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 range 5 mg to 10 mg once daily
- Maximum: 10 mg per day
- Can be taken with or without food
- Moderate to Severe Alzheimer's Disease
- Starting dosage 5 mg administered once per day in the evening, just prior to retiring
- 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
- A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months
- Dosing range 10 mg to 23 mg once daily
- Maximum: 23 mg per day
- The 23 mg tablet should not be split, crushed, or chewed; can be taken with or without food
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Mild to Moderate Alzheimer’s Disease: 5 mg to 10 mg once daily ( 2.1 ) • Moderate to Severe Alzheimer’s Disease: 10 mg to 23 mg once daily ( 2.2 ) 2.1 Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablets is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets 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. 2.2 Dosing in Moderate to Severe Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablets is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with moderate to severe Alzheimer’s disease is 23 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. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months. 2.3 Administration Information Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food. The donepezil hydrochloride 23 mg tablet should not be split, crushed, or chewed.
2.1 Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablets is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets 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.
2.2 Dosing in Moderate to Severe Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablets is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with moderate to severe Alzheimer’s disease is 23 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.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Donepezil side effects
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The most common side effects with donepezil include:
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Trouble sleeping (insomnia)
- Muscle cramps
- Fatigue (feeling tired)
- Loss of appetite
- Weight loss
When to get medical help
- Call your doctor right away if you feel faint or lightheaded — donepezil can slow the heart rate and cause fainting
- Seek help for new or worsening stomach pain, heartburn, black tarry stools, or blood in vomit — these may signal a stomach ulcer or GI bleeding
- Tell your doctor if you have new or worsening asthma or trouble breathing
- Get medical help immediately for a seizure
- Call your doctor if you have difficulty urinating
- Before any surgery or dental procedure, tell your provider you are taking donepezil — it can interact with anesthesia medications
These effects are often temporary and tend to appear more frequently at higher doses. However, call your doctor right away if you experience fainting, chest discomfort, new or severe stomach pain, blood in your stool or vomit, a seizure, or difficulty breathing — these can be signs of a more serious problem.
Donepezil warnings and precautions
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- Heart rhythm: Donepezil can slow the heart rate (bradycardia) and cause heart block (a delay in the heart's electrical signals), even in people with no known heart disease. Fainting has been reported. Tell your doctor about any heart conditions before starting.
- Anesthesia interaction: Donepezil can intensify the effect of certain muscle-relaxing drugs used during surgery or procedures. Always tell your surgeon, anesthesiologist, or dentist that you take it.
- Nausea and vomiting: These are predictable effects, especially when doses are increased. Watch closely in the first few weeks and after any dose change.
- GI bleeding and ulcers: Donepezil can increase stomach acid, raising the risk of ulcers and GI bleeding — especially at higher doses or if you also take NSAIDs or aspirin.
- Weight loss: Significant weight loss has been reported, particularly at higher doses. Monitor weight regularly.
- Seizures: Donepezil may lower the seizure threshold. Note that seizures can also be a symptom of Alzheimer's disease itself.
- Bladder problems: Donepezil may worsen difficulty urinating, particularly in people with existing bladder or prostate issues.
- Lung disease: Use with caution if you have asthma or chronic obstructive pulmonary disease (COPD) — donepezil can worsen these conditions.
- Lower-weight patients: People weighing less than 55 kg may experience more nausea, vomiting, and weight loss due to higher drug exposure relative to body size.
Donepezil interactions
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Donepezil can interact with several types of medications — make sure your doctor and pharmacist know everything you take:
- Anticholinergic drugs (used for bladder control, allergies, Parkinson's, and more) — donepezil works against their effects, potentially making both medications less effective
- Succinylcholine and similar neuromuscular blocking agents (used during anesthesia) — donepezil can amplify and prolong muscle relaxation, raising the risk of respiratory complications
- Cholinergic agonists such as bethanechol — combining these with donepezil can produce a stronger-than-intended cholinergic effect and increase side effects
- NSAIDs (ibuprofen, naproxen, etc.) and aspirin — regular use alongside donepezil significantly raises the risk of stomach ulcers and gastrointestinal bleeding
Interactions listed in the FDA-approved label
From the Donepezil prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Anticholinergic medications: Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications.
- Succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol: A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with these agents.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications ( 7.1 ) • A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists ( 7.2 ) 7.1 Use with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications. 7.2 Use with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.
7.1 Use with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications.
7.2 Use with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Donepezil
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- Do not take donepezil if you are allergic to donepezil hydrochloride or to any piperidine-containing medicines
- Tell your doctor about any heart conditions, especially slow or irregular heartbeat, heart block, or fainting episodes
- Tell your doctor if you have asthma or any chronic lung condition (such as COPD)
- Tell your doctor if you have a history of seizures
- Tell your doctor if you have a history of stomach ulcers or GI bleeding, or if you regularly take NSAIDs or aspirin
- Tell your doctor if you have trouble urinating or an enlarged prostate
- Tell your doctor about any liver or kidney disease
- Pregnancy: animal studies suggest donepezil may cause fetal harm — talk to your doctor if you are pregnant or trying to become pregnant
- Breastfeeding: it is unknown whether donepezil passes into breast milk — discuss with your doctor before breastfeeding
- Donepezil is not approved for use in children — safety and effectiveness in pediatric patients have not been established
- People weighing less than 55 kg (about 121 lbs) may be at higher risk of side effects at higher doses
Donepezil overdose
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Taking too much donepezil can cause a dangerous condition called cholinergic crisis — with severe nausea, vomiting, sweating, drooling, very slow heart rate, low blood pressure, difficulty breathing, collapse, and seizures. Severe muscle weakness can also occur, which may become life-threatening if the breathing muscles are involved.
If you suspect an overdose, call a Poison Control Center or go to the emergency room immediately. Do not try to manage an overdose at home — medical treatment, including a specific antidote, may be needed.
What Donepezil does in the body
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Donepezil works by reversibly blocking acetylcholinesterase — the enzyme that breaks down acetylcholine in the brain. This raises acetylcholine levels at nerve synapses (the junctions between nerve cells), improving the brain's ability to send signals involved in memory and thinking. The drug does not alter the underlying Alzheimer's disease process, but by boosting cholinergic activity (the brain's acetylcholine system), it can help manage cognitive symptoms for some patients.
How your body processes Donepezil
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After a tablet is swallowed, donepezil is absorbed into the bloodstream — food does not meaningfully affect how much is absorbed. The drug has a long half-life of about 70 hours, meaning it stays active in the body for several days; with daily dosing, steady levels in the blood are typically reached within about 15 days. Donepezil is processed mainly by liver enzymes (CYP2D6 and CYP3A4) and leaves the body through both urine and stool. People with liver disease may clear the drug more slowly, while body weight also affects how quickly it is processed.
How to store Donepezil
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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Donepezil
173 supplements and herbal products have documented interactions with Donepezil in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 127
- Minor · 43
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Donepezil: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Donepezil — the kind of thing our pharmacy team would talk through with you at the counter.
Will donepezil cure my family member's Alzheimer's disease?
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When should I take donepezil, and does it matter if I take it with food?
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What side effects should I expect when starting donepezil?
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When should I call the doctor right away while taking donepezil?
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Are there any medications I need to be careful about combining with donepezil?
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Is donepezil safe during pregnancy or while breastfeeding?
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Is Donepezil available over the counter?
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When was Donepezil first available?
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Who makes Donepezil?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Donepezil on HelloPharmacist
Donepezil forms and strengths (how it comes)
Donepezil is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Aricept tablets are indicated for the treatment of dementia of the Alzheimer's type, with demonstrated efficacy in mild, moderate, and severe Alzheimer's disease
- Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type, with demonstrated efficacy in mild, moderate, and severe Alzheimer's disease
- Aricept should be taken in the evening, just before bedtime, with or without food
- Donepezil hydrochloride tablets should be taken in the evening, just before bedtime, with or without food
- The 23 mg tablet (Aricept or Donepezil hydrochloride) must not be split, crushed, or chewed — swallow it whole
Orally disintegrating tablet
How this form is used
- Donepezil Hydrochloride orally disintegrating tablets are indicated for the treatment of dementia of the Alzheimer's type, with demonstrated efficacy in mild, moderate, and severe Alzheimer's disease
- Donepezil Hydrochloride orally disintegrating tablets should be allowed to dissolve on the tongue, then followed with water
- Donepezil Hydrochloride orally disintegrating tablets can be taken with or without food
Donepezil on the U.S. market: products, makers and brands
How Donepezil appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
31 companies list 73 Donepezil product records with the FDA, mostly as tablet, orally disintegrating tablet; the earliest marketing or approval year on record is 1996. Brand names on the directory include Aricept, Aricept ODT, Adlarity; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Donepezil is used (Medicaid data)
A general measure of how commonly Donepezil is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Donepezil is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Donepezil prescribed? Of the 1,601 medications we measure, Donepezil ranks #327 by Medicaid prescriptions — more than 80% of them.
Utilization by Donepezil product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
donepezil hydrochloride 10 MG Oral Tablet Most dispensed
Summed across the 20 of 145 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997223
donepezil hydrochloride 5 MG Oral Tablet
Summed across the 19 of 150 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997229
donepezil hydrochloride 23 MG Oral Tablet
Summed across the 2 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1100184
donepezil hydrochloride 10 MG Disintegrating Oral Tablet
Summed across the 1 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997220
donepezil hydrochloride 5 MG Disintegrating Oral Tablet
Summed across the 1 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997226
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Donepezil, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 43 of 372 listed Donepezil NDCs with Medicaid activity.
Compare Donepezil products
A representative set of FDA-listed product records for Donepezil — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Orally disintegrating tablet | ||||
| 5 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 10 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 5 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 10 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 5 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 10 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 5 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 10 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 5 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 23 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 10 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 5 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 10 mg | Oral | DirectRx | ANDA | View NDC → |
| 5 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 23 mg | Oral | Dr. Reddys Laboratories Limited | ANDA | View NDC → |
| 23 mg | Oral | Edenbridge Pharmaceuticals LLC. | ANDA | View NDC → |
| 5 mg | Oral | Eisai Inc. | NDA | View NDC → |
| 10 mg | Oral | Eisai Inc. | NDA | View NDC → |
| 23 mg | Oral | Eisai Inc. | NDA | View NDC → |
| 5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 23 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 23 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 23 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 5 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 10 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 5 mg | Oral | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 23 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 5 mg | Oral | Quallent Pharmaceuticals Health LLC | ANDA | View NDC → |
| 10 mg | Oral | Quallent Pharmaceuticals Health LLC | ANDA | View NDC → |
| 5 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 5 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 5 mg | Oral | ScieGen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | ScieGen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Solco Healthcare US, LLC × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Solco Healthcare US, LLC × 2 listings | ANDA | View NDC → |
| 23 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 10 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 23 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
Showing 73 of 73 products — FDA National Drug Code Directory. See every product, package size and price: browse all 73 Donepezil NDCs →
Donepezil side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Donepezil — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Donepezil in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Donepezil FDA approval history
How Donepezil went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Donepezil recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Donepezil recall since July 2021, covering 2 product listings. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09 Lots: Batch 17605 FDA record D-0177-2024 →
- Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09 Lots: Batch 17616 FDA record D-0176-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 135447 4 dose forms · 8 strengths
-
Dose form (SCDF) Disintegrating Oral Tablet RxCUI 483068In current FDA listings -
Dose form (SCDF) Oral Solution RxCUI 483071No current FDA listingClinical drug / strength (SCD) hydrochloride 1 MG/MLRxCUI 997216 -
Dose form (SCDF) Oral Tablet RxCUI 371957In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 997223hydrochloride 23 MGRxCUI 1100184hydrochloride 5 MGRxCUI 997229 -
Dose form (SCDF) Transdermal System RxCUI 2597445No current FDA listingClinical drug / strength (SCD) 168 HR donepezil 0.208 MG/HRRxCUI 2597446168 HR donepezil 0.417 MG/HRRxCUI 2597456
Look up RxCUI 135447 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Donepezil supply and shortage status
Whether Donepezil is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Donepezil costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 23 mg | $0.735 per tablet | NDC details & price history |
| Tablet · Oral | 10 mg | $0.048 per tablet | NDC details & price history |
| Tablet · Oral | 5 mg | $0.044 per tablet | NDC details & price history |
| Tablet · Oral | 23 mg | $0.794 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Donepezil brand names
Donepezil is sold under 3 brand names in the FDA directory — Aricept, Aricept ODT, Adlarity. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Donepezil: manufacturers and labelers
31 companies list Donepezil products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Macleods Pharmaceuticals Limited, A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 7 more on the FDA NDC directory.
Donepezil drug class (RxNorm)
Donepezil belongs to the Cholinesterase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Donepezil page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. American Health Packaging is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →