DABIGATRAN for Mitral valve replacement: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where DABIGATRAN was used for Mitral valve replacement.
Most Reported Side Effects for DABIGATRAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | 210 | 10.1% | 44 | 157 |
| Hypotension | 167 | 8.0% | 11 | 139 |
| Atrial fibrillation | 150 | 7.2% | 3 | 110 |
| Drug interaction | 143 | 6.9% | 7 | 95 |
| Haemorrhage | 141 | 6.8% | 21 | 84 |
| Anaemia | 131 | 6.3% | 12 | 113 |
| Dizziness | 123 | 5.9% | 6 | 97 |
| Acute kidney injury | 120 | 5.8% | 14 | 99 |
| Drug ineffective | 118 | 5.7% | 10 | 88 |
| Fall | 117 | 5.6% | 3 | 97 |
| Gastric haemorrhage | 111 | 5.3% | 0 | 94 |
| Melaena | 100 | 4.8% | 5 | 90 |
| Haematuria | 85 | 4.1% | 2 | 62 |
| Cardiac failure | 79 | 3.8% | 7 | 65 |
| Dyspnoea | 76 | 3.7% | 7 | 61 |
Other Indications for DABIGATRAN
Atrial fibrillation (997)
Product used for unknown indication (478)
Anticoagulant therapy (127)
Deep vein thrombosis (58)
Cerebrovascular accident prophylaxis (48)
Pulmonary embolism (43)
Cerebrovascular accident (35)
Thrombosis prophylaxis (32)
Prophylaxis (23)
Atrial flutter (17)
Other Drugs Used for Mitral valve replacement
WARFARIN (218)
RIVAROXABAN (33)
HEPARIN (29)
APIXABAN (26)
ENOXAPARIN (18)
ASPIRIN (13)
PHENPROCOUMON (11)
CLOPIDOGREL BISULFATE (10)
APROTININ (9)
AMIODARONE (6)