ALTEPLASE for Device occlusion: Side Effects & Safety Data
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There are 179 adverse event reports in the FDA FAERS database where ALTEPLASE was used for Device occlusion.
Most Reported Side Effects for ALTEPLASE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| No adverse event | 2,456 | 19.4% | 0 | 17 |
| Off label use | 1,752 | 13.8% | 137 | 135 |
| Gingival bleeding | 1,018 | 8.0% | 18 | 44 |
| Cerebral haemorrhage | 819 | 6.5% | 357 | 232 |
| Death | 818 | 6.5% | 818 | 58 |
| Haemorrhage intracranial | 615 | 4.9% | 247 | 143 |
| Angioedema | 603 | 4.8% | 37 | 192 |
| Haemorrhage | 536 | 4.2% | 172 | 107 |
| Drug ineffective | 524 | 4.1% | 69 | 99 |
| Haemorrhagic transformation stroke | 496 | 3.9% | 168 | 127 |
| Product storage error | 371 | 2.9% | 1 | 2 |
| Intercepted medication error | 244 | 1.9% | 0 | 0 |
| Hypotension | 242 | 1.9% | 48 | 80 |
| Intercepted product storage error | 227 | 1.8% | 0 | 0 |
| Vomiting | 224 | 1.8% | 25 | 76 |
Other Indications for ALTEPLASE
Ischaemic stroke (2,786)
Product used for unknown indication (2,073)
Cerebrovascular accident (1,630)
Cerebral infarction (1,334)
Thrombolysis (1,142)
Pulmonary embolism (617)
Acute myocardial infarction (610)
Myocardial infarction (193)
Complication associated with device (168)
Thrombosis (99)