FDA
- Status: approved
🇺🇸 Donafenib in United States
81 US adverse-event reports
Marketing authorisations
FDA
- Application: NDA008102
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: TACE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA016235
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: TACE
- Indication: CAPSULE — ORAL
- 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: 81
Most-reported reactions
- Therapy Partial Responder — 22 reports (27.16%)
- Off Label Use — 8 reports (9.88%)
- Rash — 8 reports (9.88%)
- Palmar-Plantar Erythrodysaesthesia Syndrome — 7 reports (8.64%)
- Abdominal Pain — 6 reports (7.41%)
- Diarrhoea — 6 reports (7.41%)
- Hypertension — 6 reports (7.41%)
- Myelosuppression — 6 reports (7.41%)
- Nausea — 6 reports (7.41%)
- Pyrexia — 6 reports (7.41%)
Donafenib in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Donafenib approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Donafenib in United States?
Lu Wang, MD, PhD is the originator. The local marketing authorisation holder may differ — check the official source linked above.