BETRIXABAN: 35 Adverse Event Reports & Safety Profile
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35
Total FAERS Reports
2 (5.7%)
Deaths Reported
34
Hospitalizations
35
As Primary/Secondary Suspect
Jun 23, 2017
FDA Approved
Discontinued
Status
FDA Application: 208383 ·
Patent Expires: Sep 8, 2028 · First Report: 2018 · Latest Report: 201906
What Are the Most Common BETRIXABAN Side Effects?
#1 Most Reported
Traumatic haemorrhage
11 reports (31.4%)
#2 Most Reported
Gastrointestinal haemorrhage
11 reports (31.4%)
#3 Most Reported
Haemorrhage
7 reports (20.0%)
All BETRIXABAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | 11 | 31.4% | 0 | 11 |
| Traumatic haemorrhage | 11 | 31.4% | 1 | 11 |
| Haemorrhage | 7 | 20.0% | 1 | 7 |
| Haemorrhage intracranial | 5 | 14.3% | 0 | 5 |
Who Reports BETRIXABAN Side Effects? Age & Gender Data
Most reports from: US. View detailed demographics →
Is BETRIXABAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2018 | 11 | 2 | 11 |
| 2019 | 20 | 0 | 20 |
What Is BETRIXABAN Used For?
| Indication | Reports |
|---|---|
| Thrombosis prophylaxis | 35 |
Official FDA Label for BETRIXABAN
Official prescribing information from the FDA-approved drug label.