PRAZAXA: 160 Adverse Event Reports & Safety Profile
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160
Total FAERS Reports
25 (15.6%)
Deaths Reported
76
Hospitalizations
160
As Primary/Secondary Suspect
12
Life-Threatening
12
Disabilities
First Report: 20110514 · Latest Report: 20140618
What Are the Most Common PRAZAXA Side Effects?
#1 Most Reported
Cerebral infarction
20 reports (12.5%)
#2 Most Reported
Embolic stroke
12 reports (7.5%)
#3 Most Reported
Drug ineffective
10 reports (6.3%)
All PRAZAXA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cerebral infarction | 20 | 12.5% | 1 | 7 |
| Embolic stroke | 12 | 7.5% | 1 | 7 |
| Drug ineffective | 10 | 6.3% | 2 | 6 |
| Cardiac failure | 9 | 5.6% | 0 | 4 |
| Activated partial thromboplastin time prolonged | 8 | 5.0% | 0 | 5 |
| Interstitial lung disease | 8 | 5.0% | 2 | 6 |
| Cardiac failure chronic | 6 | 3.8% | 2 | 5 |
| Fall | 6 | 3.8% | 1 | 5 |
| Death | 5 | 3.1% | 5 | 1 |
| Renal impairment | 5 | 3.1% | 0 | 3 |
Who Reports PRAZAXA Side Effects? Age & Gender Data
Average age: 76.0 years. Most reports from: JP. View detailed demographics →
Is PRAZAXA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 6 | 1 | 5 |
| 2012 | 11 | 0 | 8 |
| 2013 | 54 | 14 | 26 |
| 2014 | 40 | 6 | 23 |
What Is PRAZAXA Used For?
| Indication | Reports |
|---|---|
| Atrial fibrillation | 62 |
| Cerebrovascular accident prophylaxis | 50 |
| Product used for unknown indication | 32 |
| Prophylaxis | 6 |
PRAZAXA vs Alternatives: Which Is Safer?
PRAZAXA vs PRAZEPAM
PRAZAXA vs PRAZIQUANTEL
PRAZAXA vs PRAZOSIN
PRAZAXA vs PREDNICARBATE
PRAZAXA vs PREDNISOLONE
PRAZAXA vs PREDNISOLONE METAZOATE
PRAZAXA vs PREDNISOLONE\PREDNISOLONE\PREDNISOLONE
PRAZAXA vs PREDNISONE
PRAZAXA vs PREGABALIN
PRAZAXA vs PREMARIN
Official FDA Label for PRAZAXA
Official prescribing information from the FDA-approved drug label.