🇺🇸 NIVOLUMAB in United States

24,932 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. Malignant Neoplasm Progression — 5,190 reports (20.82%)
  2. Death — 3,658 reports (14.67%)
  3. Diarrhoea — 2,791 reports (11.19%)
  4. Off Label Use — 2,668 reports (10.7%)
  5. Fatigue — 2,133 reports (8.56%)
  6. Pyrexia — 2,032 reports (8.15%)
  7. Nausea — 1,761 reports (7.06%)
  8. Dyspnoea — 1,689 reports (6.77%)
  9. Pneumonia — 1,533 reports (6.15%)
  10. Pneumonitis — 1,477 reports (5.92%)

Source database →

NIVOLUMAB 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 NIVOLUMAB approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.