🇺🇸 TIRABRUTINIB in United States

36 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. Leukoencephalopathy — 6 reports (16.67%)
  2. Off Label Use — 5 reports (13.89%)
  3. Drug Ineffective — 4 reports (11.11%)
  4. Enterocolitis Infectious — 4 reports (11.11%)
  5. Acute Kidney Injury — 3 reports (8.33%)
  6. Anaemia — 3 reports (8.33%)
  7. Infusion Related Reaction — 3 reports (8.33%)
  8. Neutrophil Count Decreased — 3 reports (8.33%)
  9. Pneumonia — 3 reports (8.33%)
  10. Cellulitis — 2 reports (5.56%)

Source database →

TIRABRUTINIB 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 TIRABRUTINIB approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.