🇺🇸 Glivec in United States

16,771 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. Death — 11,155 reports (66.51%)
  2. Malignant Neoplasm Progression — 986 reports (5.88%)
  3. Pyrexia — 725 reports (4.32%)
  4. Chronic Myeloid Leukaemia — 672 reports (4.01%)
  5. Anaemia — 630 reports (3.76%)
  6. Second Primary Malignancy — 586 reports (3.49%)
  7. Gastrointestinal Stromal Tumour — 541 reports (3.23%)
  8. Vomiting — 516 reports (3.08%)
  9. Nausea — 481 reports (2.87%)
  10. Diarrhoea — 479 reports (2.86%)

Source database →

Glivec in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Glivec approved in United States?

Yes. FDA has authorised it.

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

PETHEMA Foundation is the originator. The local marketing authorisation holder may differ — check the official source linked above.