Kcentra Side Effects
Generic name: prothrombin complex
Note: This document contains side effect information about prothrombin complex. Some of the dosage forms listed on this page may not apply to the brand name Kcentra.
Some side effects of Kcentra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Applies to prothrombin complex: intravenous powder for injection
The most common adverse reactions were headache, nausea/vomiting, arthralgia, and hypotension.
The most serious adverse reactions were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.
Common (1% to 10%): Hypotension (4.9%), tachycardia (2.9%), increased blood pressure/hypertension (2.9%)
Uncommon (0.1% to 1%): Venous thrombosis, calf (1.0%), deep vein thrombosis (1.0%), fistula clot (1.0%)
Postmarketing reports: Arterial thromboembolic events (including acute myocardial infarction and arterial thrombosis), venous thromboembolic events (including pulmonary embolism and venous thrombosis), and disseminated intravascular coagulation
Common (1% to 10%): Nausea/vomiting (3.9%), constipation (1.9%)
Postmarketing reports: Flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, and bronchospasm
Common (1% to 10%): International normalized ratio increased (2.9%), hypokalemia (1.9%)
Uncommon (0.1% to 1%): Fluid overload (1.0%)
Common (1% to 10%): Arthralgia (3.9%)
Uncommon (0.1% to 1%): Chest pain (1.0%)
Common (1% to 10%): Headache (7.8%), hemorrhage intracranial (2.9%), ischemic cerebrovascular accident (1.9%)
Common (1% to 10%): Skin laceration/contusion/subcutaneous hematoma (2.9%)
Uncommon (0.1% to 1%): Sudden death, unknown cause (1.0%)
Common (1% to 10%): Mental status changes (1.9%)
Uncommon (0.1% to 1%): Insomnia (1.0%)
Common (1% to 10%): Respiratory distress/dyspnea/hypoxia (1.9%)
Uncommon (0.1% to 1%): Abnormal breath sounds/rales (1.0%)
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