FDA — authorised 20 August 2018
- Application: NDA206709
- Marketing authorisation holder: BIOCODEX SA
- Local brand name: DIACOMIT
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 STIRIPENTOL in United States
FDA authorised STIRIPENTOL on 20 August 2018 · 704 US adverse-event reports
Marketing authorisations
FDA — authorised 20 August 2018
- Application: NDA207223
- Marketing authorisation holder: BIOCODEX SA
- Local brand name: DIACOMIT
- Indication: FOR SUSPENSION — 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: 704
Most-reported reactions
- Seizure — 125 reports (17.76%)
- Drug Ineffective — 123 reports (17.47%)
- Off Label Use — 101 reports (14.35%)
- Decreased Appetite — 69 reports (9.8%)
- Somnolence — 63 reports (8.95%)
- Drug Interaction — 59 reports (8.38%)
- Pyrexia — 45 reports (6.39%)
- Status Epilepticus — 43 reports (6.11%)
- Generalised Tonic-Clonic Seizure — 42 reports (5.97%)
- Epilepsy — 34 reports (4.83%)
STIRIPENTOL 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 STIRIPENTOL approved in United States?
Yes. FDA authorised it on 20 August 2018; FDA authorised it on 20 August 2018; FDA has authorised it.
Who is the marketing authorisation holder for STIRIPENTOL in United States?
BIOCODEX SA holds the US marketing authorisation.