🇺🇸 Thrombolytic in United States

11 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.

• Window: 28 March 2025 – 28 March 2026
• Total reports: 11

Most-reported reactions

1. Death — 2 reports (18.18%)
2. Activated Partial Thromboplastin Time Shortened — 1 report (9.09%)
3. Acute Myocardial Infarction — 1 report (9.09%)
4. Cardiac Arrest — 1 report (9.09%)
5. Cardiac Failure Congestive — 1 report (9.09%)
6. Cardiogenic Shock — 1 report (9.09%)
7. Cerebrovascular Accident — 1 report (9.09%)
8. Deep Vein Thrombosis — 1 report (9.09%)
9. Dialysis — 1 report (9.09%)
10. Drug Interaction — 1 report (9.09%)

Source database →

Frequently asked questions

Is Thrombolytic approved in United States?

Yes. FDA has authorised it.

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

Faculty Hospital Kralovske Vinohrady is the originator. The local marketing authorisation holder may differ — check the official source linked above.