FDA — authorised 30 November 1999
- Application: NDA021035
- Marketing authorisation holder: UCB INC
- Local brand name: KEPPRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Levetriracetam in United States
FDA authorised Levetriracetam on 30 November 1999 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 15 July 2003
- Application: NDA021505
- Marketing authorisation holder: UCB INC
- Local brand name: KEPPRA
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 July 2006
- Application: NDA021872
- Marketing authorisation holder: UCB INC
- Local brand name: KEPPRA
- Indication: INJECTABLE — INTRAVENOUS
- 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: 28 March 2025 – 28 March 2026
- Total reports: 10
Most-reported reactions
- Cholecystitis — 1 report (10%)
- Convulsion — 1 report (10%)
- Gallbladder Enlargement — 1 report (10%)
- General Physical Health Deterioration — 1 report (10%)
- Haematuria — 1 report (10%)
- Hospice Care — 1 report (10%)
- Hypoalbuminaemia — 1 report (10%)
- Hypocalcaemia — 1 report (10%)
- Hypokalaemia — 1 report (10%)
- Hypotension — 1 report (10%)
Other Other approved in United States
Frequently asked questions
Is Levetriracetam approved in United States?
Yes. FDA authorised it on 30 November 1999; FDA authorised it on 15 July 2003; FDA authorised it on 31 July 2006.
Who is the marketing authorisation holder for Levetriracetam in United States?
UCB INC holds the US marketing authorisation.