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Prothrombin complex Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 12, 2024.

Applies to prothrombin complex: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Patients receiving treatment with vitamin K antagonists (VKAs) may be at increased risk of thromboembolic events (TE) due to underlying disease states. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported. The potential benefits of reversing VKAs should be weighed against the potential risk of TE. Monitor patients receiving prothrombin complex concentrate (human) for signs and symptoms of TE. Resumption of anticoagulation should be carefully considered as soon as the risk of TE outweighs the risk of acute bleeding. Prothrombin complex concentrate (human) may not be suitable in patients with TE within the last 3 months prior to use.

Serious side effects of Prothrombin complex

Along with its needed effects, prothrombin complex may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking prothrombin complex:

Less common

Incidence not known

Other side effects of Prothrombin complex

Some side effects of prothrombin complex may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

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.[Ref]

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[Ref]

Gastrointestinal

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

Hypersensitivity

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

Metabolic

Common (1% to 10%): International normalized ratio increased (2.9%), hypokalemia (1.9%)

Uncommon (0.1% to 1%): Fluid overload (1.0%)[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia (3.9%)

Uncommon (0.1% to 1%): Chest pain (1.0%)[Ref]

Nervous system

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

Other

Common (1% to 10%): Skin laceration/contusion/subcutaneous hematoma (2.9%)

Uncommon (0.1% to 1%): Sudden death, unknown cause (1.0%)[Ref]

Psychiatric

Common (1% to 10%): Mental status changes (1.9%)

Uncommon (0.1% to 1%): Insomnia (1.0%)[Ref]

Respiratory

Common (1% to 10%): Respiratory distress/dyspnea/hypoxia (1.9%)

Uncommon (0.1% to 1%): Abnormal breath sounds/rales (1.0%)[Ref]

References

1. (2013) "Product Information. Kcentra (prothrombin complex)." CSL Behring LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.