DABIGATRAN ETEXILATE for Off label use: Side Effects & Safety Data
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There are 5 adverse event reports in the FDA FAERS database where DABIGATRAN ETEXILATE was used for Off label use.
Most Reported Side Effects for DABIGATRAN ETEXILATE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | 4,081 | 11.0% | 1,013 | 3,611 |
| Cerebrovascular accident | 2,175 | 5.9% | 216 | 1,192 |
| Fall | 1,786 | 4.8% | 315 | 1,312 |
| Ischaemic stroke | 1,581 | 4.3% | 147 | 1,054 |
| Anaemia | 1,412 | 3.8% | 240 | 1,244 |
| Haemorrhage | 1,324 | 3.6% | 397 | 735 |
| Death | 1,025 | 2.8% | 1,025 | 284 |
| Rectal haemorrhage | 964 | 2.6% | 200 | 751 |
| Cerebral haemorrhage | 946 | 2.6% | 483 | 633 |
| Upper gastrointestinal haemorrhage | 861 | 2.3% | 205 | 794 |
| Atrial fibrillation | 858 | 2.3% | 79 | 538 |
| Off label use | 840 | 2.3% | 73 | 334 |
| Acute kidney injury | 805 | 2.2% | 218 | 658 |
| Lower gastrointestinal haemorrhage | 757 | 2.0% | 141 | 702 |
| Procoagulant therapy | 737 | 2.0% | 4 | 621 |
Other Indications for DABIGATRAN ETEXILATE
Atrial fibrillation (20,492)
Product used for unknown indication (11,730)
Cerebrovascular accident prophylaxis (2,567)
Thrombosis prophylaxis (1,113)
Anticoagulant therapy (780)
Deep vein thrombosis (668)
Pulmonary embolism (527)
Cerebrovascular accident (337)
Thrombosis (229)
Atrial flutter (209)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)