DABIGATRAN for Atrial fibrillation: Side Effects & Safety Data
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There are 997 adverse event reports in the FDA FAERS database where DABIGATRAN was used for Atrial fibrillation.
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
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)
Embolism venous (13)
Other Drugs Used for Atrial fibrillation
RIVAROXABAN (52,584)
DABIGATRAN ETEXILATE (20,492)
APIXABAN (10,500)
AMIODARONE (9,083)
WARFARIN (8,680)
EDOXABAN (3,855)
ASPIRIN (2,993)
DOFETILIDE (2,439)
PRADAXA (2,325)
METOPROLOL (1,542)