🇺🇸 TNKase in United States

FDA authorised TNKase on 2 June 2000 · 954 US adverse-event reports

Marketing authorisation

FDA — authorised 2 June 2000

  • Application: BLA103909
  • Marketing authorisation holder: GENENTECH
  • Status: supplemented

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. Off Label Use — 339 reports (35.53%)
  2. No Adverse Event — 274 reports (28.72%)
  3. Cerebral Haemorrhage — 67 reports (7.02%)
  4. Angioedema — 53 reports (5.56%)
  5. Haemorrhage Intracranial — 48 reports (5.03%)
  6. Death — 42 reports (4.4%)
  7. Haemorrhage — 40 reports (4.19%)
  8. Medication Error — 33 reports (3.46%)
  9. Haemorrhagic Transformation Stroke — 31 reports (3.25%)
  10. Cerebrovascular Accident — 27 reports (2.83%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is TNKase approved in United States?

Yes. FDA authorised it on 2 June 2000.

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

GENENTECH holds the US marketing authorisation.