PROTAMINE for Heparin neutralisation therapy: Side Effects & Safety Data
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There are 61 adverse event reports in the FDA FAERS database where PROTAMINE was used for Heparin neutralisation therapy.
Most Reported Side Effects for PROTAMINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Hypotension | 133 | 22.4% | 15 | 26 |
| Anaphylactic reaction | 64 | 10.8% | 8 | 19 |
| Drug ineffective | 59 | 9.9% | 13 | 14 |
| Post procedural haemorrhage | 49 | 8.2% | 5 | 15 |
| Cardiac arrest | 36 | 6.1% | 14 | 9 |
| Therapeutic product effect decreased | 31 | 5.2% | 0 | 0 |
| Haemorrhage | 29 | 4.9% | 12 | 12 |
| Blood pressure decreased | 27 | 4.5% | 4 | 3 |
| Bradycardia | 27 | 4.5% | 6 | 8 |
| Circulatory collapse | 26 | 4.4% | 11 | 6 |
| Vasoplegia syndrome | 18 | 3.0% | 4 | 12 |
| Dyspnoea | 17 | 2.9% | 1 | 3 |
| Pulmonary hypertension | 17 | 2.9% | 5 | 6 |
| Hypersensitivity | 16 | 2.7% | 6 | 3 |
| Drug interaction | 15 | 2.5% | 1 | 11 |
Other Indications for PROTAMINE
Procoagulant therapy (152)
Product used for unknown indication (125)
Surgery (19)
Coronary artery bypass (17)
Cardiac operation (15)
Haemorrhage (13)
General anaesthesia (12)
Vascular operation (11)
Angiocardiogram (9)
Aortic valve replacement (9)