COUMADINE: 73 Adverse Event Reports & Safety Profile
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73
Total FAERS Reports
16 (21.9%)
Deaths Reported
52
Hospitalizations
73
As Primary/Secondary Suspect
11
Life-Threatening
6
Disabilities
First Report: 201012 · Latest Report: 20140516
What Are the Most Common COUMADINE Side Effects?
#1 Most Reported
Anaemia
13 reports (17.8%)
#2 Most Reported
International normalised ratio increased
12 reports (16.4%)
#3 Most Reported
Melaena
10 reports (13.7%)
All COUMADINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 13 | 17.8% | 1 | 12 |
| International normalised ratio increased | 12 | 16.4% | 5 | 9 |
| Melaena | 10 | 13.7% | 2 | 9 |
| Gastrointestinal haemorrhage | 8 | 11.0% | 2 | 5 |
| Drug interaction | 6 | 8.2% | 1 | 5 |
| Haemorrhage | 6 | 8.2% | 0 | 5 |
| Renal failure acute | 6 | 8.2% | 3 | 5 |
| Asthenia | 5 | 6.9% | 2 | 3 |
| Drug reaction with eosinophilia and systemic symptoms | 5 | 6.9% | 1 | 5 |
| Haematoma | 5 | 6.9% | 0 | 5 |
Who Reports COUMADINE Side Effects? Age & Gender Data
Average age: 74.3 years. Most reports from: FR. View detailed demographics →
Is COUMADINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 0 |
| 2011 | 3 | 0 | 3 |
| 2012 | 12 | 5 | 10 |
| 2013 | 28 | 9 | 21 |
| 2014 | 21 | 2 | 16 |
What Is COUMADINE Used For?
| Indication | Reports |
|---|---|
| Atrial fibrillation | 14 |
| Product used for unknown indication | 8 |
| Pulmonary embolism | 7 |
Official FDA Label for COUMADINE
Official prescribing information from the FDA-approved drug label.