PRADAX: 11 Adverse Event Reports & Safety Profile
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11
Total FAERS Reports
5 (45.5%)
Deaths Reported
6
Hospitalizations
11
As Primary/Secondary Suspect
2
Life-Threatening
First Report: 2012 · Latest Report: 201402
What Are the Most Common PRADAX Side Effects?
#1 Most Reported
Ischaemic stroke
2 reports (18.2%)
#2 Most Reported
Haemorrhage intracranial
2 reports (18.2%)
#3 Most Reported
Gastrointestinal haemorrhage
2 reports (18.2%)
All PRADAX Side Effects by Frequency
No side effect data available.
Who Reports PRADAX Side Effects? Age & Gender Data
Average age: 74.2 years. Most reports from: CA. View detailed demographics →
Is PRADAX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 1 |
| 2013 | 2 | 1 | 2 |
| 2014 | 2 | 2 | 1 |
What Is PRADAX Used For?
| Indication | Reports |
|---|---|
| Atrial fibrillation | 5 |
| Product used for unknown indication | 5 |
Official FDA Label for PRADAX
Official prescribing information from the FDA-approved drug label.