COUMADIN: 310 Adverse Event Reports & Safety Profile
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310
Total FAERS Reports
22 (7.1%)
Deaths Reported
173
Hospitalizations
310
As Primary/Secondary Suspect
9
Life-Threatening
6
Disabilities
First Report: 199801 · Latest Report: 20140609
What Are the Most Common COUMADIN Side Effects?
#1 Most Reported
International normalised ratio increased
56 reports (18.1%)
#2 Most Reported
Anaemia
22 reports (7.1%)
#3 Most Reported
Drug interaction
21 reports (6.8%)
All COUMADIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| International normalised ratio increased | 56 | 18.1% | 1 | 40 |
| Anaemia | 22 | 7.1% | 2 | 20 |
| Drug interaction | 21 | 6.8% | 0 | 19 |
| Fall | 20 | 6.5% | 4 | 15 |
| Contusion | 19 | 6.1% | 1 | 9 |
| Epistaxis | 18 | 5.8% | 0 | 11 |
| Gastrointestinal haemorrhage | 18 | 5.8% | 1 | 16 |
| Diarrhoea | 16 | 5.2% | 1 | 12 |
| Haemorrhage | 16 | 5.2% | 0 | 11 |
| Dyspnoea | 14 | 4.5% | 2 | 8 |
| Cerebrovascular accident | 13 | 4.2% | 3 | 9 |
| Nausea | 13 | 4.2% | 1 | 7 |
| Fatigue | 12 | 3.9% | 0 | 4 |
| Haematuria | 11 | 3.6% | 0 | 7 |
| Pulmonary embolism | 11 | 3.6% | 2 | 10 |
| Anxiety | 10 | 3.2% | 1 | 10 |
| Arthralgia | 10 | 3.2% | 0 | 7 |
| Dizziness | 10 | 3.2% | 1 | 10 |
| Drug ineffective | 10 | 3.2% | 0 | 4 |
| Vomiting | 10 | 3.2% | 0 | 7 |
Who Reports COUMADIN Side Effects? Age & Gender Data
Average age: 69.5 years. Most reports from: US. View detailed demographics →
Is COUMADIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2001 | 2 | 0 | 1 |
| 2004 | 1 | 0 | 1 |
| 2007 | 1 | 0 | 1 |
| 2008 | 2 | 1 | 1 |
| 2009 | 1 | 0 | 1 |
| 2010 | 2 | 0 | 1 |
| 2011 | 12 | 3 | 7 |
| 2012 | 14 | 2 | 11 |
| 2013 | 82 | 5 | 55 |
| 2014 | 71 | 3 | 48 |
What Is COUMADIN Used For?
| Indication | Reports |
|---|---|
| Atrial fibrillation | 55 |
| Product used for unknown indication | 50 |
| Deep vein thrombosis | 18 |
| Anticoagulant therapy | 10 |
| Thrombosis | 10 |
| Cerebrovascular accident prophylaxis | 8 |
| Pulmonary embolism | 8 |
| Cerebrovascular accident | 5 |
COUMADIN vs Alternatives: Which Is Safer?
COUMADIN vs COUMADIN TABS
COUMADIN vs COVID-19 CONVALESCENT PLASMA
COUMADIN vs COVID-19 VACCINE
COUMADIN vs COVID-19 VACCINE NOS
COUMADIN vs COZAAR
COUMADIN vs CRANBERRY
COUMADIN vs CREATINE
COUMADIN vs CREON
COUMADIN vs CRESTOR
COUMADIN vs CRISABOROLE
Official FDA Label for COUMADIN
Official prescribing information from the FDA-approved drug label.