🇺🇸 NIRAPARIB in United States

12,438 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. Nausea — 1,982 reports (15.94%)
  2. Fatigue — 1,942 reports (15.61%)
  3. Constipation — 1,625 reports (13.06%)
  4. Platelet Count Decreased — 1,309 reports (10.52%)
  5. Off Label Use — 1,166 reports (9.37%)
  6. Insomnia — 1,027 reports (8.26%)
  7. Blood Pressure Increased — 1,017 reports (8.18%)
  8. Headache — 826 reports (6.64%)
  9. Product Dose Omission Issue — 796 reports (6.4%)
  10. Decreased Appetite — 748 reports (6.01%)

Source database →

NIRAPARIB 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 NIRAPARIB approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.