🇺🇸 Recombinant tissue plasminogen activator in United States

22 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. Haemorrhage Intracranial — 9 reports (40.91%)
  2. Angioedema — 2 reports (9.09%)
  3. Condition Aggravated — 2 reports (9.09%)
  4. Paralysis — 2 reports (9.09%)
  5. Paresis — 2 reports (9.09%)
  6. Brain Oedema — 1 report (4.55%)
  7. Carotid Arterial Embolus — 1 report (4.55%)
  8. Carotid Artery Occlusion — 1 report (4.55%)
  9. Cerebral Infarction — 1 report (4.55%)
  10. Diplopia — 1 report (4.55%)

Source database →

Recombinant tissue plasminogen activator 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 Recombinant tissue plasminogen activator approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Recombinant tissue plasminogen activator in United States?

University of Cincinnati is the originator. The local marketing authorisation holder may differ — check the official source linked above.