Donepezil is a cholinesterase inhibitor sold in the U.S. under 4 brand and generic names, for alzheimer disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Donepezil Hydrochloride (application ANDA090551). Other donepezil products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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.
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 1200 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | Not yet rated | Prescription | System | Generic | $1 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| T004 | 23 mg | white | round | — |
| T004 | 23 mg | white | round | — |
| 5 | 5 mg | white | round | — |
| 10 | 10 mg | yellow | round | — |
| X;11 | 5 mg | white | round | — |
| F;L;28;10 | 28 mg / 10 mg | blue |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 )
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.
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| 3 | Not yet rated | Prescription | Tablet | Generic | $1 | View → |
| 4 | Not yet rated | Prescription | Tablet | Generic | $1 | View → |
| capsule |
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| F;L;21;10 | 21 mg / 10 mg | blue, orange | capsule | — |
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| LPMD;14;10 | 14 mg / 10 mg | green | capsule | — |
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| LPMD;28;10 | 28 mg / 10 mg | blue | capsule | — |
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| F;L;7;10 | 7 mg / 10 mg | green, orange | capsule | — |
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| F;L;14;10 | 14 mg / 10 mg | green | capsule | — |
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