Kcentra Side Effects

Generic Name: prothrombin complex

Note: This page contains information about the side effects of prothrombin complex. Some of the dosage forms included on this document may not apply to the brand name Kcentra.

Not all side effects for Kcentra may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Applies to prothrombin complex: intravenous powder for injection

General

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.

Cardiovascular

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

Gastrointestinal

Common (1% to 10%): Nausea/vomiting (3.9%), constipation (1.9%)

Hypersensitivity

Postmarketing reports: Flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, and bronchospasm

Metabolic

Common (1% to 10%): International normalized ratio increased (2.9%), hypokalemia (1.9%)
Uncommon (0.1% to 1%): Fluid overload (1.0%)

Musculoskeletal

Common (1% to 10%): Arthralgia (3.9%)
Uncommon (0.1% to 1%): Chest pain (1.0%)

Nervous system

Common (1% to 10%): Headache (7.8%), hemorrhage intracranial (2.9%), ischemic cerebrovascular accident (1.9%)

Other

Common (1% to 10%): Skin laceration/contusion/subcutaneous hematoma (2.9%)
Uncommon (0.1% to 1%): Sudden death, unknown cause (1.0%)

Psychiatric

Common (1% to 10%): Mental status changes (1.9%)
Uncommon (0.1% to 1%): Insomnia (1.0%)

Respiratory

Common (1% to 10%): Respiratory distress/dyspnea/hypoxia (1.9%)
Uncommon (0.1% to 1%): Abnormal breath sounds/rales (1.0%)

More about Kcentra (prothrombin complex)

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