🇺🇸 Pradaxa (Dabigatran etexilate) in United States

57 US adverse-event reports

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: 22 April 2025 – 22 April 2026
• Total reports: 57

Most-reported reactions

1. Diarrhoea — 8 reports (14.04%)
2. Atrial Fibrillation — 7 reports (12.28%)
3. Fatigue — 7 reports (12.28%)
4. Haemoglobin Decreased — 6 reports (10.53%)
5. Vomiting — 6 reports (10.53%)
6. Asthenia — 5 reports (8.77%)
7. Cardiac Failure Congestive — 5 reports (8.77%)
8. Pneumonia — 5 reports (8.77%)
9. Anaemia — 4 reports (7.02%)
10. Dyspnoea — 4 reports (7.02%)

Source database →

Frequently asked questions

Is Pradaxa (Dabigatran etexilate) approved in United States?

Pradaxa (Dabigatran etexilate) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Pradaxa (Dabigatran etexilate) in United States?

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