🇺🇸 Depakine in United States

3,049 US adverse-event reports

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: 3,049

Most-reported reactions

1. Foetal Exposure During Pregnancy — 689 reports (22.6%)
2. Epilepsy — 616 reports (20.2%)
3. Somnolence — 320 reports (10.5%)
4. Seizure — 239 reports (7.84%)
5. Drug Interaction — 223 reports (7.31%)
6. Drug Ineffective — 215 reports (7.05%)
7. Dysmorphism — 194 reports (6.36%)
8. Thrombocytopenia — 186 reports (6.1%)
9. Pyrexia — 185 reports (6.07%)
10. Off Label Use — 182 reports (5.97%)

Source database →

Frequently asked questions

Is Depakine approved in United States?

Depakine does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Depakine in United States?

Centre d'Etude des Cellules Souches is the originator. The local marketing authorisation holder may differ — check the official source linked above.