🇺🇸 REGORAFENIB in United States

1,453 US adverse-event reports

Marketing authorisation

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.

Most-reported reactions

  1. Palmar-Plantar Erythrodysaesthesia Syndrome — 218 reports (15%)
  2. Diarrhoea — 200 reports (13.76%)
  3. Fatigue — 169 reports (11.63%)
  4. Off Label Use — 156 reports (10.74%)
  5. Asthenia — 139 reports (9.57%)
  6. Pyrexia — 117 reports (8.05%)
  7. Decreased Appetite — 115 reports (7.91%)
  8. Nausea — 115 reports (7.91%)
  9. Hypertension — 112 reports (7.71%)
  10. Malignant Neoplasm Progression — 112 reports (7.71%)

Source database →

REGORAFENIB 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 REGORAFENIB approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.