Medicine guide

Donepezil Hydrochloride

10 mg · Tablet, Film Coated

Prescription only
Cholinesterase Inhibitor

Active substance: Donepezil Hydrochloride
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: Solco Healthcare US, LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-06-30

What it is

Cholinesterase Inhibitor

Used for

Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer's type.

The label’s usual adult dose

Mild to Moderate Alzheimer's disease : 5 mg to 10 mg administered once daily ( 2.1 )

10 mg administered once daily ( 2.2) 2.1 Dosing in Mild to Moderate Alzheimer's Disease The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride 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 is 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. 2.3 Administration Information Donepezil hydrochloride should be taken in the evening, just prior to retiring. Donepezil hydrochloride can be taken with or without food.

Full directions ↓

Do not take it if

Donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ( 4 )

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

65other products contain Donepezil Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Donepezil hydrochloride 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.
Donepezil hydrochloride is an acetylcholinesterase inhibitor 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 ( 1 ).

From the official label · 2025-06-30 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Half-life70 h

Mostly cleared after≈ 2 weeksfive half-lives — our arithmetic

How the body breaks it down

Donepezil is both excreted in the urine intact and extensively metabolized to four major metabolites, two of which are known to be active, and a number of minor metabolites, not all of which have been identified.

With food

The rate and extent of absorption of donepezil hydrochloride tablets are not influenced by food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-06-30

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Mild to Moderate Alzheimer's disease : 5 mg to 10 mg administered once daily ( 2.1 )
Moderate to Severe Alzheimer’s Disease :
10 mg administered once daily ( 2.2) 2.1 Dosing in Mild to Moderate Alzheimer's Disease The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride 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 is 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. 2.3 Administration Information Donepezil hydrochloride should be taken in the evening, just prior to retiring. Donepezil hydrochloride can be taken with or without food.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia ( 5.1 ).
Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block ( 5.2 ).
Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases ( 5.3 ).
Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers ( 5.4 ).
Cholinomimetics may cause bladder outflow obstructions ( 5.6 ).
Cholinomimetics are believed to have some potential to cause generalized convulsions ( 5.7 ).
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease ( 5.8 ). 5.1 Anesthesia Donepezil hydrochloride, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. 5.2 Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil hydrochloride. 5.3 Nausea and Vomiting Donepezil hydrochloride, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea, and vomiting. These effects, when they occur, appear more frequently with the 10 mg/day dose than with the 5 mg/day dose. Although in most cases, these effects have been transient, sometimes lasting one to three weeks, and have resolved during continued use of donepezil hydrochloride, patients should be observed closely at the initiation of treatment and after dose increases. 5.4 Peptic Ulcer Disease and GI Bleeding Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of donepezil hydrochloride in a dose of 5 mg/day to 10 mg/day have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. 5.6 Genitourinary Conditions Although not observed in clinical trials of donepezil hydrochloride, cholinomimetics may cause bladder outflow obstruction. 5.7 Neurological Conditions:
Seizures Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer's disease. 5.8 Pulmonary Conditions Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women.
In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data].
In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
The background risks of major birth defects and miscarriage for the indicated population are unknown.
Data Animal Data Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 20 times the MRHD on a mg/m 2 basis), respectively.
Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose.
The no-effect dose of 3 mg/kg/day is approximately 3 times the MRHD on a mg/m 2 basis.
Risk Summary There are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for donepezil hydrochloride and any potential adverse effects on the breastfed infant from donepezil hydrochloride or from the underlying maternal condition.
8.
USE IN SPECIFIC POPULATIONS Pregnancy:
Based on animal data, may cause fetal harm ( 8.1 ).
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women.
In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data].
In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
The background risks of major birth defects and miscarriage for the indicated population are unknown.
Data Animal Data Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 20 times the MRHD on a mg/m 2 basis), respectively.
Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose.
The no-effect dose of 3 mg/kg/day is approximately 3 times the MRHD on a mg/m 2 basis.
8.2 Lactation Risk Summary There are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for donepezil hydrochloride and any potential adverse effects on the breastfed infant from donepezil hydrochloride or from the underlying maternal condition.
8.4 Pediatric Use The safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use Alzheimer's disease is a disorder occurring primarily in individuals over 55 years of age.
The mean age of patients enrolled in the clinical studies with donepezil hydrochloride was 73 years; 80% of these patients were between 65 and 84 years old, and 49% of patients were at or above the age of 75.
The efficacy and safety data presented in the clinical trials section were obtained from these patients.
There were no clinically significant differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.
As in any case of overdose, general supportive measures should be utilized.
Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse, and convulsions.
Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.
Tertiary anticholinergics such as atropine may be used as an antidote for donepezil hydrochloride overdosage.
Intravenous atropine sulfate titrated to effect is recommended:
an initial dose of 1.0 to 2.0 mg IV with subsequent doses based upon clinical response.
Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate.
It is not known whether donepezil hydrochloride and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).
Dose-related signs of toxicity in animals included reduced spontaneous movement, prone position, staggering gait, lacrimation, clonic convulsions, depressed respiration, salivation, miosis, tremors, fasciculation, and lower body surface temperature.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Alzheimer's disease is a disorder occurring primarily in individuals over 55 years of age.
The mean age of patients enrolled in the clinical studies with donepezil hydrochloride was 73 years; 80% of these patients were between 65 and 84 years old, and 49% of patients were at or above the age of 75.
The efficacy and safety data presented in the clinical trials section were obtained from these patients.
There were no clinically significant differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old.

Quoted from the official label, section “Geriatric Use”.

Side effects

The following serious adverse reactions are described below and elsewhere in the labeling:
Cardiovascular Conditions [see Warnings and Precautions ( 5.2 )]
Nausea and Vomiting [see Warnings and Precautions ( 5.3 )]
Peptic Ulcer Disease and GI Bleeding [see Warnings and Precautions ( 5.4 )]
Genitourinary Conditions [see Warnings and Precautions ( 5.6 )]
Neurological Conditions: Seizures [see Warnings and Precautions ( 5.7 )]
Pulmonary Conditions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Donepezil hydrochloride has been administered to over 1,700 individuals during clinical trials worldwide. Approximately 1,200 of these patients have been treated for at least 3 months and more than 1,000 patients have been treated for at least 6 months. Controlled and uncontrolled trials in the United States included approximately 900 patients. In regards to the highest dose of 10 mg/day, this population includes 650 patients treated for 3 months, 475 patients treated for 6 months, and 116 patients treated for over 1 year. The range of patient exposure is from 1 to 1,214 days. Mild to Moderate Alzheimer’s Disease Adverse Reactions Leading to Discontinuation The rates of discontinuation from controlled clinical trials of donepezil hydrochloride due to adverse reactions for the donepezil hydrochloride 5 mg/day treatment groups were comparable to those of placebo treatment groups at approximately 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day was higher at 13%. The most common adverse reactions leading to discontinuation, defined as those occurring in at least 2% of patients and at twice or more the incidence seen in placebo patients, are shown in Table 1. Table 1. Most Common Adverse Reactions Leading to Discontinuation in Patients with Mild to Moderate Alzheimer’s Disease Adverse Reaction Placebo (n=355) % 5 mg/day Donepezil Hydrochloride (n=350) % 10 mg/day Donepezil Hydrochloride (n=315) % Nausea 1 1 3 Diarrhea 0 <1 3 Vomiting <1 <1 2 Most Common Adverse Reactions The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by donepezil hydrochloride’s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue, and anorexia. These adverse reactions were often transient, resolving during continued donepezil hydrochloride treatment without the need for dose modification. There is evidence to suggest that the frequency of these common adverse reactions may be affected by the rate of titration. An open-label study was conducted with 269 patients who received placebo in the 15- and 30-week studies. These patients were titrated to a dose of 10 mg/day over a 6-week period. The rates of common adverse reactions were lower than those seen in patients titrated to 10 mg/day over one week in the controlled clinical trials and were comparable to those seen in patients on 5 mg/day. See Table 2 for a comparison of the most common adverse reactions following one and six week titration regimens. Table 2. Comparison of Rates of Adverse Reactions in Mild to Moderate Patients Titrated to 10 mg/day over 1 and 6 Weeks No titration One week titration Six week titration Adverse Reaction Placebo (n=315) % 5 mg/day (n=311) % 10 mg/day (n=315) 5 10 mg/day (n=269) % Nausea 6 5 19 6 Diarrhea 5 8 15 9 Insomnia 6 6 14 6 Fatigue 3 4 8 3 Vomiting 3 3 8 5 Muscle cramps 2 6 8 3 Anorexia 2 3 7 3 Table 3 lists adverse reactions that occurred in at least 2% of patients in pooled placebo-controlled trials who received either donepezil hydrochloride 5 mg or 10 mg and for which the rate of occurrence was greater for patients treated with donepezil hydrochloride than with placebo. In general, adverse reactions occurred more frequently in female patients and with advancing age. Table 3. Adverse Reactions in Pooled Placebo-Controlled Clinical Trials in Mild to Moderate Alzheimer’s Disease Adverse Reaction Placebo (n=355) % Donepezil Hydrochloride (n=747) % Percent of Patients with any Adverse Reaction 72 74 Nausea 6 11 Diarrhea 5 10 Headache 9 10 Insomnia 6 9 Pain, various locations 8 9 Dizziness 6 8 Accident 6 7 Muscle Cramps 2 6 Fatigue 3 5 Vomiting 3 5 Anorexia 2 4 Ecchymosis 3 4 Abnormal Dreams 0 3 Depression <1 3 Weight Loss 1 3 Arthritis 1 2 Frequent Urination 1 2 Somnolence <1 2 Syncope 1 2 Severe Alzheimer’s Disease (donepezil hydrochloride 5 mg/day and 10 mg/day) Donepezil hydrochloride has been administered to over 600 patients with severe Alzheimer’s disease during clinical trials of at least 6 months duration, including three double-blind, placebo-controlled trials, two of which had an open label extension. Adverse Reactions Leading to Discontinuation The rates of discontinuation from controlled clinical trials of donepezil hydrochloride due to adverse reactions for the donepezil hydrochloride patients were approximately 12% compared to 7% for placebo patients. The most common adverse reactions leading to discontinuation, defined as those occurring in at least 2% of donepezil hydrochloride patients and at twice or more the incidence seen in placebo, were anorexia (2% vs. 1% placebo), nausea (2% vs. <1% placebo), diarrhea (2% vs. 0% placebo), and urinary tract infection (2% vs. 1% placebo). Most Common Adverse Reactions The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving donepezil hydrochloride and at twice or more the placebo rate, are largely predicted by donepezil hydrochloride’s cholinomimetic effects. These include diarrhea, anorexia, vomiting, nausea, and ecchymosis. These adverse reactions were often transient, resolving during continued donepezil hydrochloride treatment without the need for dose modification. Table 4 lists adverse reactions that occurred in at least 2% of patients in pooled placebo-controlled trials who received donepezil hydrochloride 5 mg or 10 mg and for which the rate of occurrence was greater for patients treated with donepezil hydrochloride than with placebo. Table 4. Adverse Reactions in Pooled Controlled Clinical Trials in Severe Alzheimer’s Disease Body System/Adverse Reaction Placebo (n=392) % Donepezil Hydrochloride (n=501) % Percent of Patients with any Adverse Reaction 73 81 Accident 12 13 Infection 9 11 Diarrhea 3 4 Anorexia 2 3 Vomiting 2 3 Nausea 1 2 Insomnia <1 2 Ecchymosis 2 3 Headache 1 2 Pain 1 2 Back Pain 4 10 Eczema 4 8 Hallucinations 4 8 Hostility 2 6 Increase in Creatine Phosphokinase 2 5 Nervousness 1 3 Fever 1 2 Chest Pain <1 2 Confusion 4 5 Dehydration 2 3 Depression 2 3 Dizziness 1 3 Emotional Lability 1 2 Hemorrhage 1 2 Hyperlipemia 1 2 Personality Disorder 1 2 Somnolence 1 2 Personality Disorder 1 2 Syncope 2 3 Urinary Incontinence 1 2 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of donepezil hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Abdominal pain, agitation, aggression, cholecystitis, confusion, convulsions, hallucinations, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, rhabdomyolysis, QTc prolongation, and torsade de pointes.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients and caregivers to take donepezil hydrochloride only once per day, as prescribed. Instruct patients and caregivers that donepezil hydrochloride can be taken with or without food. Advise patients and caregivers that donepezil hydrochloride may cause nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and decreased appetite. Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant. Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang, 317024, China Zhejiang Huahai Pharmaceutical Technology Co., Ltd. Jiangnan, Linhai, Zhejiang 317000, China Distributed by:
Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised:
06/2025 200145-04 (Huahai Xunqiao) 20090-02 (Huahai Tech) DONEPEZIL HYDROCHLORIDE PATIENT PACKAGE INSERT Donepezil (doe NEP e zil) Hydrochloride Tablets, USP
Tablets:
5 mg and 10 mg Read this Patient Information that comes with donepezil hydrochloride before you start taking it and each time
you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about Alzheimer’s disease or treatment for it.
If you have questions, ask the doctor or pharmacist. What is donepezil hydrochloride? Donepezil hydrochloride comes as donepezil hydrochloride film-coated tablets in dosage strengths of 5 mg and 10 mg. Donepezil hydrochloride is a prescription medicine to treat mild, moderate and severe Alzheimer’s disease. Donepezil hydrochloride can help with mental function and with doing daily tasks. Donepezil hydrochloride does not work the same in all people. Some people may:
Seem much better
Get better in small ways or stay the same
Get worse over time but slower than expected
Not change and then get worse as expected Donepezil hydrochloride does not cure Alzheimer's disease. All patients with Alzheimer's disease get worse over time, even if they take donepezil hydrochloride. Donepezil hydrochloride has not been approved as a treatment for any medical condition in children. Who should not take donepezil hydrochloride?
Do not take donepezil hydrochloride
if you are allergic to any of the ingredients in donepezil hydrochloride tablets or to medicines that contain piperidines. Ask your doctor
if you are not sure. See the end of this leaflet for a list of ingredients in donepezil hydrochloride tablets. What should I tell my doctor before taking donepezil hydrochloride? Tell the doctor about all of your present or past health problems and conditions. Include:
Any heart problems including problems with irregular, slow, or fast heartbeats
Asthma or lung problems
A seizure
Stomach ulcers
Difficulty passing urine
Liver or kidney problems
Trouble swallowing tablets
Present pregnancy or plans to become pregnant. It is not known if donepezil hydrochloride can harm an unborn baby.
Present breast-feeding. It is not known if donepezil hydrochloride passes into breast milk. Talk to your doctor about the best way to feed your baby
if you take donepezil hydrochloride. Tell the doctor about all the medicines
you take, including prescription and non-prescription medicines, vitamins, and herbal products. Donepezil hydrochloride and other medicines may affect each other. Be particularly sure to tell the doctor
if you take aspirin or medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). There are many NSAID medicines, both prescription and non-prescription. Ask the doctor or pharmacist
if you are not sure if any of your medicines are NSAIDs. Taking NSAIDs and donepezil hydrochloride together may make you more likely to get stomach ulcers. Donepezil hydrochloride taken with certain medicines used for anesthesia may cause side effects. Tell the responsible doctor or dentist that
you take donepezil hydrochloride before
you have:
surgery
medical procedures
dental surgery or procedures Know the medicines that
you take. Keep a list of all your medicines. Show it to your doctor or pharmacist before you start a new medicine. How should
you take donepezil hydrochloride?
Take donepezil hydrochloride exactly as prescribed by the doctor. Do not stop donepezil hydrochloride or change the dose yourself. Talk with your doctor first.
Take donepezil hydrochloride one time each day. Donepezil hydrochloride can be taken with or without food.
If you miss giving the patient a dose of donepezil hydrochloride, just wait. Take only the next dose at the usual time.
Do not
take 2 doses at the same time.
If donepezil hydrochloride is missed for 7 days or more, talk with your doctor before starting again.
If you take too much donepezil hydrochloride at one time, call your doctor or poison control center, or go to the emergency room right away. What are the possible side effects of donepezil hydrochloride? Donepezil hydrochloride may cause the following serious side effects:
slow heartbeat and fainting. This happens more often in people with heart problems. Call your doctor right away
if you feel faint or lightheaded while taking donepezil hydrochloride.
more stomach acid. This raises the chance of ulcers and bleeding. The risk is higher for people who have ulcers, or take aspirin or other NSAIDs.
worsening of lung problems in people with asthma or other lung disease.
seizures.
difficulty passing urine. Call your doctor right away if you have:
fainting.
heartburn or stomach pain that is new or won't go away.
nausea or vomiting, blood in the vomit, dark vomit that looks like coffee grounds.
bowel movements or stools that look like black tar.
new or worse asthma or breathing problems.
seizures.
difficulty passing urine. The most common side effects of donepezil hydrochloride are:
nausea
diarrhea
not sleeping well
vomiting
muscle cramps
feeling tired
not wanting to eat These side effects may get better after
you take donepezil hydrochloride for a while. This is not a complete list of side effects with donepezil hydrochloride. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Solco Healthcare U. S., LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088. How should donepezil hydrochloride be stored? Store donepezil hydrochloride at room temperature between 59° to 86°F (15° to 30°C). Keep donepezil hydrochloride and all medicines out of the reach of children. General information about donepezil hydrochloride Medicines are sometimes prescribed for conditions that are not mentioned in this Patient Information Leaflet.
Do not use donepezil hydrochloride for a condition for which it was not prescribed. Do not give donepezil hydrochloride to other people, even if they have the same symptoms or condition. It may harm them. This leaflet summarizes the most important information about donepezil hydrochloride.
If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about donepezil hydrochloride that is written for health professionals. What are the ingredients in Donepezil Hydrochloride Tablets, USP? Active ingredient:
donepezil hydrochloride Inactive ingredients:
Donepezil Hydrochloride 5 mg and 10 mg film-coated tablets:
corn starch, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The film of 5 mg tablets coating contains FD&C BLUE #2/INDIGO CARMINE ALUMINUM LAKE, hypromellose, polyethylene glycol, and titanium dioxide. The film of 10 mg tablets coating contains hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide. Rx Only Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang, 317024, China Zhejiang Huahai Pharmaceutical Technology Co., Ltd. Jiangnan, Linhai, Zhejiang 317000, China Distributed by:
Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised:
06/2025 Rx Only

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Donepezil hydrochloride is supplied as film-coated, round tablets containing 5 mg, 10 mg of donepezil hydrochloride, USP.
The 5 mg tablets are blue, round, film-coated tablets, debossed with ‘HH205' on one side.
The 10 mg tablets are light yellow, round, film-coated tablets, debossed with ‘HH210’ on one side.
Tablets: 5 mg, 10 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

16.1 Donepezil Hydrochloride Tablets Supplied as film-coated, round tablets containing 5 mg, or 10 mg of donepezil hydrochloride, USP. The 5 mg tablets are blue, round, film-coated tablets, debossed with ‘HH205' on one side.
Bottles of 30 (NDC# 43547-275-03)
Bottles of 90 (NDC# 43547-275-09)
Bottles of 1,000 (NDC# 43547-275-11) The 10 mg tablets are light yellow, round, film-coated tablets, debossed with ‘HH210' on one side.
Bottles of 30 (NDC# 43547-276-03)
Bottles of 90 (NDC# 43547-276-09)
Bottles of 1,000 (NDC# 43547-276-11) Storage
Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).

Quoted from the official label, section “How Supplied”.

How to store it

Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).

Quoted from the official label, section “Storage and Handling”.

What is in it

Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H -inden-1-one hydrochloride.
Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020.
It has an empirical formula of C 24 H 29 NO 3 HCl and a molecular weight of 415.96.
Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane.
Donepezil Hydrochloride Tablets, USP, are available for oral administration in film-coated tablets containing 5 mg or 10 mg of donepezil hydrochloride, USP.
Inactive ingredients in 5 mg and 10 mg tablets are corn starch, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose.
The film of 5 mg tablets coating contains FD&C Blue #2/INDIGO CARMINE ALUMINUM LAKE, hypromellose, polyethylene glycol, and titanium dioxide.
The film of 10 mg tablets coating contains hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide.
Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (26)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 26 of 26

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Canada23 matching products

Every strength and form (46)

Details

Made by	Solco Healthcare US, LLC
Active substance	Donepezil Hydrochloride
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	10 mg
Form	Tablet, Film Coated
Route	Oral
Packs	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
NDC	43547-276
NDC	43547-879

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

55 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated45 products
Tablet6 products
- 5 mg3
  5 mg · 3 companies
- 10 mg2
  10 mg · 2 companies
  - ACI Healthcare USA, Inc.
  - Bryant Ranch Prepack
- 23 mg
Tablet, Orally Disintegrating4 products
- 5 mg2
  5 mg · 2 companies
  - Macleods Pharmaceuticals Limited
  - Unichem Pharmaceuticals (USA), Inc.
- 10 mg2
  10 mg · 2 companies
  - Macleods Pharmaceuticals Limited
  - Unichem Pharmaceuticals (USA), Inc.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Aricept5 mgPrescription onlyTablet, Film Coated Eisai Inc. · Donepezil Hydrochloride Aricept10 mgPrescription onlyTablet, Film Coated Eisai Inc. · Donepezil Hydrochloride Aricept23 mgPrescription onlyTablet, Film Coated Eisai Inc. · Donepezil Hydrochloride Donepezil5 mgPrescription onlyTablet Camber Pharmaceuticals, Inc. · Donepezil Hydrochloride Donepezil10 mgPrescription onlyTablet Camber Pharmaceuticals, Inc. · Donepezil Hydrochloride Donepezil10 mgPrescription onlyTablet A-S Medication Solutions · Donepezil Hydrochloride

See every product with Donepezil Hydrochloride