🇺🇸 Rubraca in United States

FDA authorised Rubraca on 19 December 2016 · 10,769 US adverse-event reports

Marketing authorisations

FDA — authorised 19 December 2016

  • Application: NDA209115
  • Marketing authorisation holder: PHARMAAND
  • Local brand name: RUBRACA
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Fatigue — 2,503 reports (23.24%)
  2. Nausea — 2,227 reports (20.68%)
  3. Malignant Neoplasm Progression — 1,166 reports (10.83%)
  4. Decreased Appetite — 788 reports (7.32%)
  5. Constipation — 765 reports (7.1%)
  6. Vomiting — 762 reports (7.08%)
  7. Diarrhoea — 761 reports (7.07%)
  8. Asthenia — 663 reports (6.16%)
  9. Adverse Event — 571 reports (5.3%)
  10. Carbohydrate Antigen 125 Increased — 563 reports (5.23%)

Source database →

Rubraca 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 Rubraca approved in United States?

Yes. FDA authorised it on 19 December 2016; FDA has authorised it.

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

PHARMAAND holds the US marketing authorisation.