TENECTEPLASE for Ischaemic stroke: Side Effects & Safety Data
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There are 417 adverse event reports in the FDA FAERS database where TENECTEPLASE was used for Ischaemic stroke.
Most Reported Side Effects for TENECTEPLASE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 430 | 32.6% | 51 | 69 |
| No adverse event | 313 | 23.7% | 1 | 5 |
| Cerebral haemorrhage | 132 | 10.0% | 50 | 44 |
| Angioedema | 112 | 8.5% | 0 | 31 |
| Haemorrhage intracranial | 74 | 5.6% | 30 | 19 |
| Haemorrhage | 71 | 5.4% | 24 | 24 |
| Drug ineffective | 68 | 5.2% | 15 | 14 |
| Death | 60 | 4.6% | 60 | 7 |
| Haemorrhagic transformation stroke | 49 | 3.7% | 14 | 19 |
| Cerebrovascular accident | 45 | 3.4% | 19 | 17 |
| Subarachnoid haemorrhage | 42 | 3.2% | 7 | 12 |
| Ischaemic stroke | 34 | 2.6% | 13 | 21 |
| Cerebral infarction | 31 | 2.4% | 13 | 16 |
| Neurological decompensation | 29 | 2.2% | 6 | 14 |
| Treatment failure | 28 | 2.1% | 12 | 15 |
Other Indications for TENECTEPLASE
Cerebrovascular accident (246)
Acute myocardial infarction (170)
Product used for unknown indication (140)
Myocardial infarction (71)
Thrombolysis (65)
Pulmonary embolism (50)
Acute coronary syndrome (12)
Cerebral infarction (12)
Thrombosis (9)
Electrocardiogram st segment elevation (7)
Other Drugs Used for Ischaemic stroke
ALTEPLASE (2,786)
CLOPIDOGREL BISULFATE (309)
TIROFIBAN (220)
ASPIRIN (205)
ATORVASTATIN (175)
ASPIRIN DL-LYSINE (99)
RIVAROXABAN (95)
APIXABAN (89)
DABIGATRAN ETEXILATE (84)
HEPARIN (67)