FDA — authorised 25 November 1996
- Application: NDA020690
- Marketing authorisation holder: EISAI INC
- Local brand name: ARICEPT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Donepezil 5 mg in United States
FDA authorised Donepezil 5 mg on 25 November 1996 · 26 US adverse-event reports
Marketing authorisations
FDA — authorised 18 October 2004
- Application: NDA021719
- Marketing authorisation holder: EISAI INC
- Local brand name: ARICEPT
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 July 2010
- Application: NDA022568
- Marketing authorisation holder: EISAI INC
- Local brand name: ARICEPT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 26
Most-reported reactions
- Somnolence — 4 reports (15.38%)
- Confusional State — 3 reports (11.54%)
- Hypotension — 3 reports (11.54%)
- Syncope — 3 reports (11.54%)
- Vomiting — 3 reports (11.54%)
- Abnormal Behaviour — 2 reports (7.69%)
- Cognitive Disorder — 2 reports (7.69%)
- Dehydration — 2 reports (7.69%)
- Drug Interaction — 2 reports (7.69%)
- Dyspnoea — 2 reports (7.69%)
Donepezil 5 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Donepezil 5 mg approved in United States?
Yes. FDA authorised it on 25 November 1996; FDA authorised it on 18 October 2004; FDA authorised it on 23 July 2010.
Who is the marketing authorisation holder for Donepezil 5 mg in United States?
EISAI INC holds the US marketing authorisation.