Table 3.
Adverse reactions reported in (3 or more subjects) following administration of Kcentra or plasma in the randomized controlled trial for the treatment of acute major bleeding1
| Prothrombin complex concentrate (n = 103) | Plasma (n = 109) | |
| Headache | 7.8% | 1.8% |
| Hypotension | 4.9% | 2.8% |
| Nausea/vomiting | 3.9% | 0.9% |
| Arthralgia | 3.9% | 0% |
| Skin laceration/contusion/subcutaneous hematoma | 2.9% | 0.9% |
| Tachycardia | 2.9% | 0.9% |
| Blood pressure increased/hypertension | 2.9% | 0% |
| INR increased | 2.9% | 0% |
| Intracranial hemorrhage | 2.9% | 0% |
| Mental status changes | 2.9% | 0% |
| Constipation | 1.9% | 5.5% |
| Hypokalemia | 1.9% | 4.6% |
| Respiratory distress/dyspnea/hypoxia | 1.9% | 3.7% |
| Fluid overload | 1% | 5.5% |
| Breath sounds abnormal/rates | 1% | 2.8% |
| Chest pain | 1% | 2.8% |
| Insomnia | 1% | 2.8% |
| Anemia | 0% | 3.7% |
| Pulmonary edema | 0% | 3.7% |
| Transfusion reaction | 0% | 3.7% |
| Diarrhea | 0% | 2.8% |
| Hypomagnesemia | 0% | 2.8% |
Note: INR = international normalized ratio.