🇺🇸 NERATINIB in United States

FDA authorised NERATINIB on 29 July 2020 · 1,039 US adverse-event reports

Marketing authorisation

FDA — authorised 29 July 2020

  • Application: NDA208051
  • Marketing authorisation holder: PUMA BIOTECH
  • Indication: Efficacy
  • Status: approved

Read official source →

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. Diarrhoea — 235 reports (22.62%)
  2. Off Label Use — 167 reports (16.07%)
  3. Disease Progression — 103 reports (9.91%)
  4. Nausea — 101 reports (9.72%)
  5. Fatigue — 86 reports (8.28%)
  6. Vomiting — 83 reports (7.99%)
  7. Decreased Appetite — 73 reports (7.03%)
  8. Neuropathy Peripheral — 71 reports (6.83%)
  9. Cough — 64 reports (6.16%)
  10. Weight Decreased — 56 reports (5.39%)

Source database →

NERATINIB 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 NERATINIB approved in United States?

Yes. FDA authorised it on 29 July 2020.

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

PUMA BIOTECH holds the US marketing authorisation.